Q2 2023 argenx SE Earnings Call
Good morning, My name is Sarah and I will be a conference operator today I would like to welcome everyone to the call.
At this time all lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would 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. Please press star one again thank you.
I'd like to introduce Bell, sorry, that's still Jocko, Vice President Global head of corporate Communications and Investor Relations. You May now begin your conference.
Thank you operator appropriately issued earlier today with our half year 2023 financial resolved in the second quarter business updates. This can be found on our website along with a presentation for today's webcast.
Before we begin I'd like to remind you on slide too that forward looking statements maybe prevented during this call is made those statements about our future expectations clinical development regulatory timeline, the potential success of our product candidates financial projections and upcoming milestones.
Actual results may differ materially from those indicated by these statements are jenex does not under any obligation to update statements regarding the future, Oregon confirm those statements in that relation to actual results and what's required by law.
I'm drawing on the call today by <unk>, Chief Executive Officer called Rubis to financial Officer, and Karen Massey, Chief Operating Officer, I'll now turn the cough with them.
Thank you both of them both of them everywhere.
That'll be can on slide number please.
This has been an incredibly exciting private on jeopardy.
That'd be so happy to be delivered and could use the G. M. G M C I to be.
The community.
<unk> no problem.
We have successfully achieved double T milestones.
Really though at the beginning of the year.
Bringing us one step closer to our mission symptoms.
<unk>.
Some information to us.
Patients living their lives with minimal interruption.
<unk>.
So they can have more time to do things.
I enjoy.
Let me say this is <unk>.
Waving medicine.
Some meaningful vision.
Like four.
At the beginning of the year.
We outlined an ambitious plan to please spell your property stakeholders.
<unk> <unk>.
Commercially.
Submit them both to expand into earlier G. M C station segment.
<unk> the new geography.
We have made progress across both of these goals.
Talk about.
Nicole.
From the critical advice reset.
Reschedule <unk> program.
<unk>.
Dennis.
A few fragments.
<unk> the product opportunity.
Our completion.
<unk>.
It's only grill.
<unk> date of last week.
And we expect more momentum later this year.
Two faced the leader.
<unk> <unk>.
We also commitments to continued investment and innovation.
This includes both earlier.
Earlier this program.
Superbox S T.
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And also I will <unk> <unk> <unk>.
Innovation program.
I'm proud to say there'll be relied on so I could I would go for 2023.
Having achieved the muscles fill it out.
<unk>.
Like five.
Very quickly.
I would like to reset the reasons clinical <unk>, Illinois.
Last week.
<unk>.
Studying a broad based on population is.
67% of it.
H a.
Supporting a longstanding hypothesis.
P P as in <unk>.
<unk>.
<unk>.
Primary endpoint.
With an impressive feat value.
Demonstrating that this card my poodle.
<unk>, 561%.
Based on time to first suggested.
<unk>.
We had several conversations with neurologists falling out announcements.
Which were.
Around the potential for these data to create a paradigm shift.
The payments are preparing for upcoming interaction with the F D a of the data.
Simultaneously working on it.
<unk>.
Five six.
We also shared data.
Four.
He highlights.
We are advancing forward with the other studies.
The decision is fine.
Review by an independent.
Independent data monitoring, calling T 22 patients in Cornwall.
Including line will complete with the <unk>.
<unk>.
Can you confirm it favorable safety.
Profile.
The system will result in the field of study.
I'll be able to go ahead to move forward.
Based on this recommendation.
And the internal efficacy assessment.
<unk>.
<unk>.
I will be transferring to a second dose.
We plan to report results from the <unk>.
It's just the first indication for alpha.
Can you believe this could be our second plan.
<unk>.
Your own press the start to sell <unk>.
The amount of my advice.
<unk>.
Seven.
The vision of all the leadership.
<unk> quickly emerging.
And you can see the puzzle pieces coming together.
Each quote of revenue growth from Delta.
<unk>.
Data readouts from our clinical programs.
We have generated almost $500 billion in Netflix <unk> today.
Even bicycle system.
<unk>.
<unk> was approved in June .
Now have to approve commercial products for <unk>.
Alright, I have a long term commitment.
You ready.
With a G.
Important to consider what is <unk>.
The lower muscular community.
This was the largest 12.
12 at a run.
And the first that included several unique design features.
We hope.
He will set the bar.
Trials look like going forward.
To ensure the right patients are getting into the study.
Okay, I'll be impressive efficacy and safety.
Also uncovered important biology insights showing centerpiece urgency immediately.
This is what we want to be the ship the look like for all of our indications.
Doing what is best for patients.
Physician.
Frozen our fundamental understanding of disease biology.
The next <unk>.
French fries will be <unk>.
We are also innovating without a file a dime.
Including.
<unk> and <unk>.
<unk>.
That's a unified by muscle degeneration associated with the progression of the disease.
But can presented very differently with all the physical manifestations in the joints.
<unk>.
Okay.
Confirm.
Mmm.
Also characterized by the <unk> auto antibody.
We believe the field is ready to use.
To your auto antibodies signature.
Reclassify my balance.
You expect a decision next year.
Which will inform us.
With fans of the services.
And then provide the underlying biology inside.
To the <unk>.
You'll also building up our <unk>.
<unk> and then the next 119.
To have two of <unk>.
But it has also published significant demonstration data.
Underlying biology.
From a franchise perspective.
Memphis squarely into the core capabilities, we are building.
We are currently in your face.
Without James 19.
Which we will be 3000 potential income.
19 syndrome.
Yeah.
April the patient cohort.
Our commitment within the mustard with extensive cross.
First the relationships with billing commercially.
<unk> community.
Including patients physicians and advocacy groups.
We're also building a reputation clinically.
Clinical trials to be patient friendly and unlocked.
Bottles of insight.
And all of this is rooted in the scientific foundation the building in the space.
The bleeding.
And speaking of opportunities to innovate and expand out with five line going forward within neuromuscular.
And with that I'm going to turn the call over to Carl to talk to you and ask your financial.
Recent equity race.
Thank you with them.
Right.
<unk> 2023 financial results are detailed in your press release from this morning.
Only highlight the key points here.
Continued momentum Okay launch is available reflected in your second quarter revenues.
Right at 281 million total revenues.
269 in global net product sales and 12 collaboration and other revenues.
Looking at the original breakdown global pro reptiles.
Can see about 244 million was from the U S.
Million from Japan, and $12 million from Europe , and I'll distribute the mortgage.
Launched in Europe is largely Germany.
But beginning in March we started to agree with you.
In Germany at the projected negotiated price.
In September .
<unk> account for.
<unk> in Europe .
I have a mortgage will contribute in Q3 one word.
Launched in Italy.
<unk> 383 million for the second quarter.
Getting an operating loss of 2 million fill the quota.
<unk> <unk> $2 billion in cash cash equivalents and current financial assets.
With extra <unk> of approximately 1.3 billion.
The global offering we complete good last week, which will allow us to execute.
The menu opportunity said.
Perfectly on the heels of positive adhered data conviction.
Conviction and Zip code.
Pipeline.
We are still in the process.
L L increased ambition level will change our operational spin.
A day, we are not able to confirm.
Aspirin guidance of $500 million will provide an update at a later date.
Oh, now and you'll go to <unk> for a commercial update.
Let's go to slide nine.
We started the year with a clear and simple vision commercially to reach more patience with they've got glibly we.
We plan to do this by driving multi dimensional expansion in G. M G, including geographic expansion the launch about subcutaneous product and my driving usage into early at G. M G treatment lines.
We also looked ahead to the multiple data readouts expected this year and how this would drive expansion interviews patient segments over time.
I'm going to talk today about the continued strong performance from at G. M. D launch, but also about the pivot point, we are facing as you look ahead to the evolving opportunity before us.
The outstanding results from it here have strengthened conviction that we will be a litre beyond M. G. In your muscular and that we can start to leverage the launch capability to your bill to prepare for multi dimensional expansion across product presentation.
Murphy and towards your portfolio vindication.
10.
Starting with a recent commercial performance.
Great first half of the generating $489 million they've got sales over the first two quoted.
Impressive revenue number translates to more patients getting access to we've got and more opportunity for us to change patients' lives were incredibly happy with the results.
We can point to several key drivers of the momentum in the second quarter.
We are seeing consistent growth looking at month or the month you patient stuff.
We are reaching patients in earlier lines of therapy.
Still at the front end of reaching the 17000 patients. We believe we can address <unk>.
The task before us is the shift into early lines of treatment and overcome neurologist inertia.
It will take time and you're eligible game deeper experience with they've got and will also require persistent Matthew obtained.
We had been consistent prescribed growth both in terms of breads and get.
Now has more than 2100 prescribed in the U S.
A greater percentage of them each quarter are moving beyond that first script and putting additional pain patients on treatment.
We also think that we've got high true I will help with this shift.
Slide 11.
Well now a couple of weeks into the hydrilla launch and I've received scripts and shipped after five.
You'll save specific throughout the protocol, but I was very impressed by the team's readiness at the time of approval to get dragged into the channel and two patients as quickly as possible.
I'll go with this golf actually low is the only way of long term commitment to the G. M. G community with a second product options now subcutaneous.
And also to drive broke into earlier line patients by simplifying or democratizing the treatment of G. M G.
We believe out positioning should be first line after oral therapy and that will require further expansion into community practices.
The diagnosis and treatment of M. G patients can be complex and can be associated with a trial and error approach or a battery of tests.
Current treatment options, often call me safety and Tolerability challenges, which require the patient to decide between symptom control emerging side effects.
Long term safety concerns.
Requires close management from a G. M G specialist, which is why patience directly to refer to a specialist centres.
Al conviction is that with the efficacy of good got established safety and Tolerability and now it's 80, 92nd injection with high Trullo, we can expand usage deeper into the community of patient and prescribed it.
More experienced community prescribed gain more expert that will become at diagnosing M G and trading with <unk>.
Now that we have the results of the trial, we can take many of the same themes that we've seen with G. M G and apply them to C. I D P as well.
C. I D. P community has been waiting for innovation for over 30 years, and we need data. We believe we can bring transformational change to patients.
To me one of the most compelling data points for me here within 91% of eligible patients who rolled over into the open label extension study, including patience you relax in puppy and were given the option to go back to their prior therapy or to stay on this <unk>.
We see this is a good indication that the patient experience with we've got is different.
We know that there will also be unique challenges associated with a C. I D. P market based on the comfort level and loyalty associated with current treatment.
But we also see the opportunity to raise the bar on water treatment can offer taking into account the full patient experience advocacy safety and the burden associated with administration.
July 12th.
Before I wrap up until the call back with him.
Shipped to the progress, we're making with that global geographic expansion. We've had three G update since I last call and feel more ahead D C. Demonstrating the speed at which we are executing on a global strategy.
We received approval for ZIP got in China throughout partner.
At the end of June .
You will be eligible to apply to the N. R. A D. L. In 2024, which is important from a timing perspective, because it will open the opportunity to patients who are not privately insured.
I also I submitted the <unk> F Scott and it was accepted.
Oh, you're in July we also successfully completed reimbursement negotiations in Italy, marking the second country within Europe to have officially launched they've got.
Credibly proud of the team expanding access for Italian patience, just 11 months after European approval.
And loved we finalize the commercial and distribution agreement in South Korea will handle a team with a great track record as a commercial partner.
Similar to our other distribution agreements Handbook will take the lead on all regulatory and commercial activities associated they've got in South Korea.
Slide 13.
I wanted to close with the why behind all of our expansion strategies, which of the patients who are living with severe auto immune disease.
On the heels of another strong quota and a positive outcome and C. I D. P. We are more motivated than ever to drive a paradigm shift in how auto immune is treated.
Current auto immune treatments come with many tradeoffs and now with the opportunity transformative change.
Take the full patient experienced into account efficacy safety and treatment bed.
Give patients more days within not reminded of the disease.
It's the right time to meaningful change and we believe we have a unique medicine patient centric strategies and a talented team to deliver.
It back to Jim.
Thank you Karen slash 14th.
Coming back to where we started which is to look back at the plans we set forth.
Part of the year.
We have the liver from our promise to execute.
And drive sustained grove across our business.
I'm incredibly proud of the team for these children.
Do not come without your love of hard work.
We continue to show.
All the <unk>.
Commitment to innovation and execution on behalf of vision.
Our work is no problem.
And they still has a lot to look forward to.
2023.
<unk> to transform the treatment of surgery auto immune diseases.
Thank you.
The question and answer session.
The question please.
On your telephone keypad.
We ask that you please limit yourself to one question one moment. Please for your first question.
Your first question comes from the line of Caffeine a match with Bank of America. Please go ahead.
Hi, good morning, and thanks for taking my question, maybe I just wanted to focus on one of the two data catalysts that you have in the fourth quarter, specifically for the 10th against read out maybe 10 can you frame for us.
In terms of the top line results that you're going to be presenting and in terms of feedback that you've gotten from physicians of what would be considered good data banks.
Good morning, and thanks for being with US today and thank you for your password discretion is one of the key cancel if I think of the remaining part of the year.
<unk>. The primary endpoint is mainly comes through and around I'm, just pulling a statistically significant.
<unk> possible, so interesting I've got taken off versus placebo.
Big round of steroids siblings.
So the address to show statistically significant vanilla plan at any point on which is going to information on minimum update unusual in minimum dose of steroids.
<unk> secondary endpoints, we're going to unpack uhm elements, which are really critical to patients.
So what is the extent to which we can pay for steroids. That's very important <unk> and also what is the speech a disease control that means stopping the formation of newly issues and then followed by the closing of the Elysian. So this is this is in a nutshell the key points blending both directly.
Scared about location scared of us.
Thanks for the question.
Your next question comes from the line of Derek <unk>. Please go ahead.
Hey, good morning, and thanks for taking my questions I actually have two brief questions. If I may so first.
Hoping you could talk a little bit about the sales momentum for dessert you.
You're talking about somebody X U S. G O coming online you've launched high school Oh now in this pushed into earlier line. So I guess, if you think about the second half which of these do you think it's gonna be the biggest incremental contributor to sales growth and then the second question you stay within the P. R.
To start the Ted trial for <unk>, given what we're seeing with <unk> recent performance in the thyroid disease market has your optimism around that commercial opportunity changed at all and when will you communicate the full details of that trial design.
Thank you and thanks for being with Us today Uhm.
You're a Christian 182, <unk> and then I will take your questions won't be okay.
Thanks, Tim <unk>.
Thanks for the question and did you say I think we we continue to see strong momentum and I'll say consistent momentum in the the the launcher and they've got and and actually I would say that in the second half of the year.
Continue to see that consistency across all of the factors that you mentioned I I think we we continue to see that with penetrating earlier lines of treatment and expanding that prescriber base I see no reason why that won't continue through the year.
Try to get reimbursement discussion ongoing in Europe , and so we believe those will continue through the year and the high to low early indications that that we have positive feedback and that will also contribute to outgrow. It. So I think one of the one of the strengths that we have is that we are driving growth across all.
But as I mentioned and I think that should help us just to maintain some consistent momentum. Thank you Karen.
Let's see the question.
Just <unk> around and try to start the trial.
<unk> smiled design addicted to those will start to talk Elizabeth about how do we think about positioning.
Do you believe that is an urgent G G as in disease.
Business Douglas.
Correlation between the size of your auto antibody on the one hand and your clinical symptoms on the other hand, <unk> as well please to shine on all three dimensions of application safety.
So stay tuned on the T V story. Thank you.
Negative.
Your next question comes from the line of the Iron Werebear with T. D. Cowan. Please go ahead.
Thanks for taking my question and congrats on a great quarter.
Maybe as we look into the <unk> decision early next year <unk> can you give us any parameters at all as to what you're looking for you know from a power perspective.
Those first you know 30 or 40 patients.
What is the actual go go no go electric thank you.
No. Thank you you're the best technology to draw associated with the Chevy Beach lines. So I think we need to see a minimum level of responds in the first 40 patients.
Give us a convention the dishes not April <unk> and as I see it which confirms the dishes of George G. Mediated diseases. We believe so think of a seamless face to face three <unk> of course, we will look at the totality of the data into the safety.
But as a seamless phase two three design in order not to lose <unk> wide space, which means face to face.
You know that we have conviction D T.
<unk> extra sauce to a certain extent as a delisting steps for <unk>.
We believe based on all the homework visit this is truly allergies with a disease.
Very exciting indication as to to focus on.
35, and my medical needs.
Innovation and the safety profile of <unk> turned out to be even more important.
That is will be in touch with us. So we very much looking forward to the decision for me. Thank you.
Okay is it just based on placebo or you drinking a little bit on the corollary of some of the competition out there with the rhythm Sylvia <unk>, but some of it is showing robust responses or you sort of do you have that in your sights as well into the go they'll go decision. Thank you.
Gonna go over the basically look at the initial picture, which is emerging I mean being a position there to look at longterm effects of the drugs, maybe you're alluding to the long term clinical benefits, we have seen in some of the political stations and fish too.
We actually changed the course of disease.
Database, we will also collect deeply trial, but they will not be part of the Golden rule decision points.
Okay.
Thank you.
Okay here.
Your next question comes from the line of Danielle, which Raymond James. Please go ahead.
Hi, good morning.
So much have a question I have a follow up on on the growth outlets have gotten a second half.
I'm just curious I'm from a modeling perspective, how we should think about <unk>, even sang a consistent may 20th <unk> quarter over quarter growth in the U S is.
Is it fair motto that moving forward and what kind of impact if any should we expect from the recent <unk>. Thank you.
Hi, Danielle this call. Thank you for your question I mean, I think that as a a dollar numbers become bigger we cannot expect it continued 20% gross court reporter of course also whereby thriller loans.
Really important but we operations, while we get those by your contract to replace it could take a quarter.
<unk> to to get that remember <unk>.
That's how long it took us with this card Uhm 18 months ago, you terms of competition. Yes. We now do you have competition in terms of Verizon.
And of course, nothing good comes diabetes T. Five <unk> <unk> the market is getting more competitive and also we have another C. Five.
The T V campaign, and it's getting a little bit more crowded overall of course, we still expect to grow but I figured withdrawals. We'll go we'll be paying for it to ask are you into the second half of the year.
Thank you. Thank you for your questions.
[noise] question comes from the line of Thomas Smith.
Partners. Please go ahead.
Good morning, Thanks for taking my questions and let me have my congrats on a great quarter.
Just wanted to ask you a little bit of a tie level question you have a really strong balance sheet pretty incredible launch momentum and G. M G.
Comment on how you're thinking about straight strategic priority given to your significant cash balance how're you thinking about investing in between commercial infrastructure.
The guard indication expansion or early pipeline development are you considering any other.
The opportunities.
Mmm. Thank you for your question.
Thank you for being with us today.
We can apply for most of them so the.
<unk> have such a strong cash balance.
Was in a position to fully assess any promotions I mentioned.
Nothing on the table of your emails opportunity behavior, followed us we do have an incredible pipeline with more than 60 clinical trials swelling now.
The message full you will receive a sense of urgency to move forward.
This trial designs and packing.
The clinical potential Lovato drugs, you didn't see that 117 has proven to be a drug with the first efficacy data and <unk> and <unk> two.
The <unk>.
A new wave of innovation, which is progressing smoothly clinical towards the clinic, so filing from all services.
Also means that within the position of science I think there's a ton of innovation, which we are bringing forward from our platform throughout a firefly and into the marketplace.
Of course always externally focused looking carefully fold opportunity this real life.
<unk>, we also do not a social <unk> cheese symptom so.
<unk> with a new life.
Without any doubt you know until two partnership conversations remember the double discovery mobile by our I T programs that email is renovation program by definition is a partnership model. So <unk> is in the DNA of the company.
Thank you for the question.
[noise]. Your next question comes from the line of miles Minter with William Blair. Please go ahead.
Uh huh.
Question on the potential self administration and for Scott Hartzell or did you have conversations during lively and when the product got approved from us any drive us and what it would take.
<unk> to get self administration in the libel the ability to potentially self administer and the <unk> extension, if it's sufficient to get a self administration option on that <unk> <unk> pay and modest any grab it. Thanks.
Okay. Thanks, Thanks for being with US today and thank you for the question.
Just a quick recap on the situation.
Thank you for the first generation so Q V. C. A combination of you know a relative complex interface.
<unk> steps you need to do.
No specifics of the disease indication like double vision.
Limited dexterity muscle weakness and the combination of the two made it properly too high barriers or sell the administration and in the United States remember that the.
Discussions are still ongoing in Japan and Europe .
<unk> delivered.
It's too early to get ahead of ourselves, hoping for C. I D P.
To go for a fee uhm, you'll be meeting with the F. D. A calibrating expectations, we need to prepare.
Mm submitted and as part of this conversation. So I think we will also tackle the topic of self administration.
Importantly, you'll need to know that you know we are working very hard on the second generation of the subcutaneous probably presentation of a <unk> that is a prefilled syringe.
Is a simplification of the user interface and I think there'll be happy again.
A real shot on goal to go to sell the administration, but stations you know step by step.
I think the curtains.
<unk> is already a significant.
For helping us to penetrate on the market.
Decoupling the patient from the infusion change should be avoiding the infusion bottlenecks advil simplifying access for the station to the drug because now any S. G T.
Administer the drugs anywhere.
Thank you for the question.
Thanks for the questions congrats on the quota.
Your next question comes from the <unk>.
Line reactions to media.
<unk>. Please go ahead.
Thank you for taking my question just two quick ones for me in terms of the patient makes currently on on the drug can you just comment you know where are we in comes with refractory patients and what percentage of the patients are getting three treatment and at what frequency and.
And then the second question is.
Thoughts on providing that Avenue guide is not that you have.
We have lots of experience with the launch thanks.
Yeah. Thank you Justin and thanks for being with US and I will give the question all percentage of recycling stations and numbers will be treatments. After Karen and then mail it out again very quickly per months.
On your revenue questions. Thank you yeah.
Yeah. Thanks for the question, so I would take the patient mix any particular refractory week at.
At the early stages of launch we were seeing a lot high usage and the refractory patients when physicians with just starting to get experience with the medicine and what we've seen over time is consistent movement into those earlier lines of treatment and we continue to see that that shift and that momentum as the execute on our plans.
The in terms of the re treatment with frequency what you can imagine it cause it the bell curve. Some patients are individualized dosing since I'm, a very frequent somewhat less frequent but what we see in the data is that is right in line with what our assumptions what are and what we provided before which is around five cycles for a patient that kept me.
Changed.
And you have to install your thank you for your question in terms of Finance Gardens, I mean, we're not ready yet they're still too many variables.
The gentleman costs will be really important China alone should we only charge <unk> cute. So I think we need to see if your <unk> will get back to you on finance Department. Thank you.
Okay.
Your next question comes on the line.
<unk> with Morgan Stanley . Please go ahead.
Hi, good morning, Thanks for taking my question.
So we just had one on the recent launch of <unk> got into my senior Gravis.
Understanding it's early but is there any color you could provide on the demand trends, you're seeing from prescribers and patience towards subcu verses Ivy in and if you've been able to glean any transit this space with the launch on the types of patients better leaning more towards so cute.
On that same topic.
Are you able to provide any commentary at this point on how you're finding early receptivity towards that's up to.
<unk> option for <unk>.
No. Thank you I'm going to try and limit the question to one.
Can you comment on a few lost on Alex and and any plans, which which we received thank you yeah, absolutely I mean, it's really too early to tell.
Any of the details that you asked about that but what we are saying we believe we have strong value proposition and the outlook outlook is strong we are getting early positive signal those available for one more out speaking with your allergist and and the feedback we're getting <unk>, obviously it takes awhile.
To get the pay a policy in place we have had one policy that's been put in place, but we need to continue to work on that so that it impacts the uptake right at this moment, but we are seeing enrollment come in we are being positive feedback and we strongly believe uhm you'll have the conviction that the 30 to 92nd is it is a real advantage for patients.
Thank you Karen and thanks for beta further questions. Thank you. Thank you.
Hey, good morning, and thanks for taking my question, maybe just a follow up on an earlier question. Please don't syringe could could you just remind us of the <unk> update so Q uhm Prefilled syringe. It it does look like even enrolling us <unk>.
Trailing healthy volunteers for the <unk> for a few months based on <unk>, just curious what other clinical work, we would need to be.
Carrying out for that to be <unk>. If you could just outline the expected date of phone development path there uhm that'd be helpful. Thank you.
Elephant, thank you for being with us today, and I'm I'm I'm going to comment on your questions. So the couple of data you should always needs to be generated in <unk> in order to file for the P. S. S. So we have the Bible study.
Connect your call out to be you're going to have the human factor stall is you need to complete but then of course, there's a whole invisible train <unk>.
Needs to happen with our let's see the animals. So it's spelled D C come together and generate all the data including stability data.
I should be ready to submit uhm, we will be getting more granular on the timeline over the course of next year.
So they should release a priority for us because we think it's gonna be in a neighbor off the longterm rollout of dogs and of course, a key enabler for solid administration. So stay tuned fluffy works with the data stream generations.
Your next question comes from the line of Alex Thompson with Stifel. Please go ahead.
Yeah. Good morning, Thanks for taking my question I guess had a quick follow up on pemphigus as we think about steroid papering in the drug arm what does it look like they're in in your view is it no steroid or what is a good dose of steroids and these patients look like to be clinically meaningful. Thanks.
Thanks for the session and just to get into <unk>, we actually just extra versus placebo and in both arms. The background is Thursday evening protocol. So all patients thoughts on the same amount of steroids and then you know with a <unk>.
Find protocols you need to step down.
Jews and.
And the iPhone actually is a complete remission that means that you're free of skin lesions on the minimum dose of steroids and does the minimum doors. The way. It is used in the investigators so it's a very stringent endpoints.
To reach and actually you need to be at eight weeks and see our unlimited minimum dose of steroids in order to effectively <unk> is very high.
You cannot expect you know, we're very hardest upholstered in excess but it's really designed to push placebo as close to zero as possible. So let's look for the telephone.
The city is statistically significant between active and placebo and that will be six three and the primary endpoint.
In the secondary influences I've said pickles unpacks, all the information, which actually is very relevant for patients.
Okay. The total curious abuse of steroids and the ability to effectively stay at her meaningfully and level.
Of course speech, a disease control and you know episodes of formation of <unk>. So.
Full expense, which we will be able to unpack in the top line data.
Alright, Thanks question.
Your next question comes from the line of a cached Hilary with Jeffrey Please go ahead.
Hi, This is Amy I'm, sorry card. Thanks, so much for taking my question just two from US first on <unk>.
After I take him out to be getting chronically as long term maintenance or would it be more of a one time treatment and then finally on your expectations could you. Please visit your expectations for when you reach profitability. Thanks, so much.
Thank you uhm.
Two questions for the price of <unk>.
I'll get a second question very quickly to Carl.
Comment on parts first.
This is a key question alone coverage. So uhm, if my colleague and Chief Medical Officer local T V into the call. He would say look we need to learn whether you know it's sufficient to cleanse the body one in a one off treatment side of it they've got to be.
Symptom free oranges would you need to go into more chronic dosing in Monica with pulse to basically effectively take care of the patients. This is one of the key questions. We need to address thanks to the biology question industry stream comes to file Uhm. So stay tuned to it all for you to learn about it and Carl would you prefer.
Commenting on the question <unk>.
Yeah, she path to profitability available not gonna common to invest in terms of timing what I will say is that we order sustainable company, which stands on your own legs and yeah. I think that's all we will say for now thank you.
Your next question comes from the line of June .
Securities. Please go ahead.
My apologies.
Your next question comes from the line of <unk> <unk>.
<unk>. Please go ahead.
It's.
Thanks for taking the question just on.
And.
Is it safe to assume that you're positioning.
First one option that you compete directly with I G. And then what kind of additional work chasing you need to do to convince the teaching community that.
<unk>.
The disease than previously assumed.
Yeah. Thanks for this question.
I think that will be just like for M. G. A lot of education going on you know uhm educating of an audience on the effect is an urgency mediated disease based on data.
And and the things you could I. Please call out the way the trial of designs and debated data handouts is that there's no need to need to deposit into reflects the line or you know a line of <unk>.
The drug was equally effective in patients you know which were on steroids uhm, a diaper on therapy, which had been on the idea G. R. S. G. I G a background therapy, or which would either newly diagnosed for <unk> in the last six months, so equal advocacy equal wanting to respond to the drug are closed.
So we do not see any reason to actually go and activity niche ourselves and what we think is the size of a opportunity.
Thanks for the question.
Your next question comes from the line of June Lee.
Securities. Please go ahead.
Hey, Yeah, congrats on the progress and thanks for taking our questions you know with Capt data on hand, how are we thinking about commercial competitors mess up as <unk> versus I V. I G and C. I D. P S.
Steady state how do you think have you see the breakdown of I V. I G versus F. C. R. F C R and targeted products.
Thank you.
Yes, uhm. Thank thanks for the question and I can take that it's a little bit too early for us to come in and instead of Ivy I G. <unk> market share. If you will we still need to continue to do the work up in the commercialization plan, but but what I can take it to your first question, we see a really strong value property.
And when we look at the holistic.
The the holistic picture they've got in Civ P. When you think about the efficacy and just talk to that the strength of the day to day at the safety and Tolerability I think was incredibly impressive weekly it would weekly dosing and we feel that the safety profile continues to hold off the tolerability.
It is really clear uhm and then obviously the 30 to 92nd injection and we believe that we have a full package uhm that will be able to compete really well in the market and we have conviction in the product and will do the work up and share some thoughts around what that might look like this is I V I G and in the coming months.
Thank you.
Your next question comes from the line.
With Citigroup. Please go ahead.
Good morning, and thanks for taking my question just to follow up on <unk> on that the primary and secondary implants in that.
<unk>, how do you envision that sir fitting into the treatment paradigm. Just curious what is your compensation Smith physicians and how you decided that Kyle.
Uhm and is there anything you would have to overcome by transferring the patterns. Thank you.
Mmm no. Thank you sign up for this question I'm excited about our opportunity and you can get interesting disease space.
Interesting thing about <unk> is that actually it's it's an area which is wide open.
So the only treatment options in patients have today is actually steroids, which they hate with a passion.
And then redo some us which you know has a slow onset of action significant side effects and actually we will efficacy, which is significantly lower than what they have shown into clinical trials. So if you know look at the fish too clinical data for a cottage amongst you know with a very fast ball setup action.
A very highly this old space and an unexpected usability.
Difficult to see that you can start to drive a wedge between the <unk>. So I think the unique opportunity here to <unk>.
But let's not get ahead of ourselves, let's wait for the fish speed data because they will inform us about you know the best with your physician to drug going forward with excited about the opportunity and thank you for the question.
Your next question comes from the line of Chill out.
Please go ahead.
Hi, Thanks for taking the question what's the for the starting on high true, though what's the medications you're seeing switching from <unk>.
Versus patience for <unk>.
First experience with.
Sorry, I think I heard your question that it was around switches from actually low Uhm, Oh, they've got <unk> and it's just too early to tell we haven't seen.
The data on that yet, but I understand we're getting some feedback on the value proposition of <unk>.
Sure It would be disappointing if I did this will just be a switch dynamic yeah <unk> yeah, absolutely I can comment on that I can be calling in on that before the strategy here is not that way switching from <unk> to <unk>, but rather we try to open up access.
Patients in the community and elsewhere Wednesday, 92nd injection is a better option sort of getting into their lives. So yeah.
Thank you thanks for the question.
Your next question comes from the line <unk> with H T rain.
Wainwright. Please go ahead.
Hi, Good morning. Thank you for taking my questions just just following up.
Hi, Charles Ciullo, you guys actually spoken about the opportunity now too.
Get into the into the community more I'm just curious as you've been in the field more what percentage of the market does this now open up needing how many patients were sort of community based and we didn't really have great access to <unk> for whatever reason.
Yeah. It's look it's a great question I mean, I think the we still see the address <unk> is that 17000 that we've shared before uhm and we think high school allows us to really penetrate more into the community get closer to be used after the hours and so.
Really opened up that segment of the market, but with the way that I would think about it is that the address ma'am I can assist you.
Seven $8 and we're on the front end of that.
At this point in in March.
Okay, great. Thank you.
Thanks.
Your next question comes from the line of Leland.
Please go ahead.
Hey, Thanks for taking my questions with respect to emphasize apart as we look forward to the fees to a second <unk>.
Is there a particular bar you're looking to meet or is it the data merely to inform next steps and also wanted to ask with respect to that I said are you expecting to start either or both of the POC studies and G M or kidney.
Yeah, I'm unimpressed by How're Ya from.
<unk> the the name of <unk>, I mean, I would like to recall that.
So <unk> is actually molecule the fish to file asleep designed to generate P. J P. G data.
And efficacy and safety data to inform our mobile.
Ideally to those course give us a sufficient information to triangulate what was the single should be.
What we have said publicly that on a dose for number one.
Not only past independence and data does your properties a blessing from a safe can tell the ability point of view does nothing to be all sorts of completing efficacy, allowing us to version two dose cohort to.
The I D that you know, we see a separation between the two of <unk> P. K P. T mobile is fully informed.
But I believe that based on the efficacy we have seen already.
Think we have a drug <unk>.
The remaining question is <unk> what is the dog is going to be for phase three continue to document of course safety and Justice is a 500, a product of opportunity and that is very exciting as an indication.
But boy yoga to indications, which red lining up on you pretty exciting.
On track to start both files as we line up in the press release. So soon this molecule will be putting all of the three indications and we think that there's more to in fact in terms of opportunity. So.
<unk>. Thank you for your questions.
Once again, ladies and gentlemen, if you have a question.
Please pass Taiwan.
Your next question comes from the line.
C.
C. B S. Please go ahead.
Hi, Thank you for taking my question. So you have quite a few of <unk> coming up P. P. <unk> T D et cetera.
More indications in the pipeline I'm just wondering with so many indication is there anyone that you would like to highlight as he you know if there's any one is higher risk than others.
If there's any one that you can make it that will be much bigger than others in terms of commercial opportunities.
Uhm, yeah anyone anyone that you would like to highlight in particular, thank you.
Thank you.
<unk> charged some question to me because I'm easily excited about medications and it's very difficult to tell you, which one is going to be ultimately the biggest one.
No that you know the magenta Max this is going to be in his totality, a very sizable 500 products.
Quickly call optional I G T will be around trying to get our marketing authorization in Japan. So should we will have two indications on the market and then I'm very excited about my diapers file which has varied over does it surpassed the trial. The first one will be go after three distinct population in my scientists.
People are in 30 hired on the medical needs.
Really effective treatment options at all so really you're looking forward to the <unk>, the swelling and I'm paying close attention to it.
I'm very excited about the universe of opportunity indeed, all the new listing diseases.
<unk> progressing very well and then of course, we have a whole third wave indications with frankly speaking <unk>.
Still you know in the sweet spot of the drug where there is strong conviction on biology.
<unk> feasibility from a clinical electronic security point of view and revealed commercial opportunity to transform the loss of these patients. So this is.
This is the University did you go to first of opportunity, which we repulsion.
Thank you for the question.
No further questions at this time.
Conclude today's conference call. Thank you for joining US you may now disconnect your lines.
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Mmm.
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