Q4 2023 Legend Biotech Corporation Earnings Call

March 11, 2024

Step ups youre going to ask the FDA to grant this year. Thank you.

Yeah.

Hey, Jeff This is Jim.

Thank you for the question about manufacturing so I'll take that one.

We did mention at the beginning of last year that our goal is to provide the micro both IL 10000 doses per year.

Is it 2025.

Beyond that we're not providing any guidance on 2024 manufacturing scale up but I can tell you that just if you look at last year.

We applied for FDA approval for two capacity increases in archive and buyers in New Jersey, and we did successfully achieved both approval from FDA. This.

This year. Our plan is the same that is we our opinion additional <unk> capacity increases that we plan to request the FDA.

So that's the same cadence as last year.

That's our plan for 2024.

Thank you.

Okay.

Thank you. Our next question comes from Jonathan Miller with Evercore ISI. Your line is open.

Hi, guys. Thanks, so much for taking the question.

I'd like to ask about your early pipeline are.

Both.

Beyond <unk> three in that in that arm recall, what can investors look forward to it and even if you are not specifying targets can you give us a little bit of color about whether the your choices are likely to be familiar to folks will be familiar targets or if these are new a new places to go looking for a car and then separately.

Do you have any plans to get into the autoimmune space like so many of our other peers.

Yeah.

Thanks, Jonathan This is part of your question Yeah. So on the pocket of from some of our.

Fantastic.

Among others our novel I, probably can provide some high level thinking about.

Heavy truck and.

Hello, Patrick.

I'll have a few.

Apologies, firstly, so really trying to do the nomadic whom our franchise, especially for patients post treatment.

That space of AD targeting.

I'm, a little pocket as well as in our positive.

<unk> is a research empty land, that's why you see a fairly diverse appaloosa hypothesis west.

Rich.

Second upon what happens with focusing on the auto immune disease. These patients. We see this is an emerging area on the screen.

Opportunities.

In this space I think that differentiate approach is critical.

Our internal focus.

Thank you for your question.

Yes.

Alright. Thanks, so much and then one follow up if I may I noticed your your burn here at about $103 million a quarter.

It looks like you're not.

And a runway guidance to end of 'twenty five it seems like you're not guiding for a lot of improvement in burn rate or any improvements in.

Revenue was offset by a corresponding increases in spend is that a fair way to think about it.

That's correct.

<unk> been conservative.

From a premium with growth.

It's really going to be dependent upon our pipeline into our pipeline.

I mean, I think we're comfortable with our cash balance.

Pretty crazy on that program.

Yeah.

Thank you so much.

Yeah.

Thank you. Our next question comes from the Chen with Goldman Sachs. Your line is open.

Thank you for taking my questions and Ah for the upcoming <unk> meeting on Friday, So could you share a bit more about that.

Cutoff date for those data could potentially share with the committee and also for the OSP data for the <unk> treated group, who was shared in 2023 ash, which showed a very strong OS benefit compared to intent to treat group.

So, we'll discuss including as trader group as well, so which Google will likely be more important.

Per your previous communication with our regulators.

And also we're trying to understand about your initial thoughts on the Europe European countries launches, so any incremental updates on the launch and any preliminary strategy on that thank you.

Hey, this is <unk>.

I'll take your first question around <unk> so.

At this point I can tell you we submitted three data to the FDA and also EMEA overall survival because we were told by the FDA that we focus on the upcoming OTA alcohol March 15th will be overall survival. So as you mentioned the first data was submitted in the BLA.

Last year and that was part of the effort.

If that interim analysis with a data cut on November <unk> 2022.

Then as part of the day, one <unk> safety update we submitted to the FDA in October of last year, we put in another.

Update on survival from Khartoum before that with a data cut of April of last year and then most recently on January seven we submitted latest survival data from part two to start with a data cutoff December 13th.

2023, so those are the three different overall survival analysis that we provided to the FDA and those are three data that will be discussed on Friday biotech as well.

In terms of ITT versus as treated I can tell you that all our data analysis on survival benefit was provided on the basis of intention to achieve ITG and that is the all cause mortality.

Which is the most conservative scenario here, we do not plan to submit to the agency the data off of viable on the basis of that.

So I hope that answers your question about the <unk> and then I'll ask my colleague Steve to comment on the European launch given the most recent see HMP opinion, yes. Thanks.

A couple of things just to remind the listeners that our partner is responsible for the group.

For our victories launch planning outside of the United States.

And with exception of China.

As far as Europe goes.

As you mentioned.

Maybe I don't think you did mentioned we are currently in Germany.

With core victory as well as Austria, and Austria came onboard in December of last year. The intention and this is through a partner or partners in active negotiations currently around our new card or two for data.

In terms of guiding in terms of the country launch planning, we don't have anything yet to guide because I know this is a pretty fluid environment right now with the agencies in Europe and our partners are unfortunate I can't guide you at this point in time.

Got it thank you Yang anesthesia.

Thank you. Our next question comes from Yaron Werber with TD Cowen Your line is open.

Hi, This is Gino honestly as Alan Thanks for taking our question I kind of wanted to ask about Pakistan as long which is seamless.

Why do you think when we think uniquely produces.

Although we spoke to handle all of that said that it can have pretty irreversible effects. So can you.

At this point to determine useful earlier line setting, especially as competing hard to start service.

Thanks.

Hey, Dan This is Ed.

I'll take your question on Parkinsonian, well first of all if you look at the data that's both in clinical trials and also from the FDA AUR database.

This phenomenon.

Pakistan is not unique archive AJ in fact, it was reported on patients who are taking on gift Karla kimrey here and all of our banks and so forth.

<unk>.

As of end of last year, we could see about seven cases reported in the FDA database from the U S patient. So that's the number that's actually the facts.

With regard to why Youre seeing just kind of delayed parties on it I will say, there's a couple of hypothesis out there.

For example, it could be because of the T cell trafficking into the CNS on your brand when the patient has a leaky blood brain barrier after years of.

Or is the patient already had preexisting you argued situations such as by neuropathy, so that could be one of the our hypothesis. Although at this point I don't think Theres any started clinical evidence to show, which is the root cause of our pocket.

Regarding your question on <unk> in the earlier lines as we reported the agco.

Given the.

Risk mitigation strategies, we implemented following the 6K to reported from <unk>. One we were able to show that the incidents of Parkinson's was going down from about 6% and car to one to about <unk>, 5% and cartoons for that was.

Great wine case, we reported that Africa.

So we believe that if you look at the <unk>.

Earlier line patient population because of the risk mitigation and also potentially because of the patient baseline difference.

Think that is the entirety of manageable a phenomena here. Thank you.

Thank you. Our next question comes from Kelly <unk> with Jefferies. Your line is open.

Okay.

Hi, This is Dave on for Kelly.

Hey, congrats on the progress I have a couple of questions. One is the as the multiple b B C. A major inside of Labor now have you received any feedback from physician on how does the stipulation corrective versus other treatment.

Also on sale.

When do you expect to provide sales guidance and although you mentioned J&J will be responsible for all study that any color on when should we expect.

To record the first revenue in other countries and U S EU and Japan.

Yes.

Yeah.

Why don't I take the last question around sales so.

As far as the EU and Japan, I mentioned that we're already in Austria and Germany.

And unfortunately because of negotiations being ongoing we cannot comment on what country may be up next in Europe.

That includes Japan for that matter.

I think your other question had to do with selection our victory in terms of patient type what we're seeing obviously right now within the U S and in Europe.

Offsetting here in the states.

He mentioned in his opening remarks, we're running about an 80% market share insights where we are.

We are basically competing against the back months. So I think that speaks volumes in terms of preference in terms of physicians and it's an all in all risk categories, whether it be standard risk or high risk.

I think where you see some other product use around by specific uses when potentially RBC may not be available.

If a physician wants to bridge to a car T therapy, you are seeing some uptick for sure in the Bispecific space I think that has.

In terms of market erosion, where you are seeing at least in the research that were doing is youre seeing the market erosion occurring with the back book.

The device specific is used in front of car T therapy as opposed to sort this out.

Hey, Doug I'll take your first question I think it was long a label update so.

I'll provide an intuitive or is that number one is that youre all aware that in late last year. We did receive an official label update that includes a two year minimum falloff off the car to the one in.

In late line multiple myeloma with that <unk>.

Also included label update on Am Al and also Mds. So I wanted to provide a little clarification on this so if you look at the total of 97 patients from car to what we saw nine patients with 10 cases, if you look at accumulative rate.

And they all flash and yes, it's roughly 10%, but recall. This trial was started back in 2019, so essentially in the last five years the accumulated rate of AML Mds is roughly 10% now there's a paper that was published in.

In December of last year, which looked at insurance that same database over 1000 patients were triple exports, which means these patients have been treated with triple class, including one dropped from amid cost one dropdown potent behavior and then one drop on fees or the antibody.

So.

If you look at that patient population without any treatment the background rate of developing Mds or AML is roughly 3% each year. Therefore, if you look at the data from Carter, what we don't believe that is actually higher than the background rate and we already got the label update on AML and Mds now regarding the second one as you guys.

From the public communication from the FDA all six brands of car T therapies will receive label update on T cell lymphoma, and FDA believes this is a class effect. So everyone will get similar or the same language and right now we and J&J are in discussion with the FDA about exact language.

Label update.

To say that given the 23 cases reported.

The FDA and also denominated is over 27000 patients who are treated with those two trends at some of our clinical trial patients. It is a small and where risk and we think we will get the label update in the near future.

You also have a question about.

Feedback from physicians on how they think about <unk> versus other novel therapies I think now.

We have been.

In touch with the physicians and care off since the ash and at this point, we have not the Indian prescription behavior that's changed.

Based on the T.

T cell lymphoma, or <unk> and Mds, a label change and if you look at efficacy.

Physicians continue to believe that <unk> provides best in class efficacy with nearly three years PFS in late line and then also again if you saw the results from Khartoum compared to our standard of care such as CPD XIAFLEX Farmington Bank in Mexico, we saw a 74% risk reduction in progression of that and you.

We'll see you on Friday, and how <unk> has helped those patients with survival as well so at this point.

I think it is still positioned as best in class efficacy with a onetime injection convenience that is how physicians view perfect. Thank you.

Thank you.

Thank you. Our next question comes from Liana <unk> with RBC capital markets. Your line is open.

Hi, yes. Thanks for taking my question I also wanted to ask on the <unk> and I guess, specifically, how you're thinking about competitive implications coming out of that meeting I guess with regards to the drug youre going to be sharing a committee with do you think any setbacks for them are going to be a positive for you is there is less market splitting potentially less competition or do you think if they succeed.

I'm going to be helpful. Given that they can drive greater awareness and I guess is there any risk the car T space broadly being painted with the same brush depending on what.

Yes competitor present.

Thanks, Joe for the question.

So I think if you look at the <unk>.

Federal Register publications, you will see even though it's the same roster over that but it's actually two different panels on the morning of March 15, or that we'll discuss the application from.

US on our second line indication for <unk> and then in the afternoon <unk>.

Same old aircraft or Kols and experts, who will discuss the application from our competition in a third line application.

So I think it is a separate panel, it's not necessarily a panel on a car class and I believe each application will be discussed and also.

Debated by the tail end of the agency on its merits.

So I can't comment on our competition.

Applications of the data, but we firmly believe that <unk> provides overwhelming benefit or.

In the PFS and also overall survival endpoints here. So that's why we can say about this and.

If you look at car T as a cost in general in late line multiple myeloma.

Clearly the class of therapy has provided a new option for patients who are treated who have been treated and also failed all major classes, including in mid April as a leader in all phases of the antibody at that point. These states that really did not have much choice.

Besides the bcm a direct agents. So we firmly believe that there is a very important place for a <unk> directed car T. In the treatment of multiple myeloma. Thank you.

Yes.

Thank you. Our next question comes from Vikram <unk> with Morgan Stanley. Your line is open.

Hi, Good morning. Thank you for taking our sense is that we had two one on the pipeline and what on commercialization so on the pipeline.

For the <unk> two study we.

We were just curious what your latest thoughts were on timing for data from cohorts E&S.

And then on commercialization you mentioned that around 30% of patients are administered <unk> in the outpatient setting.

Hi, do you think that could go kind of in the near to midterm and what do you think facilitate some greater use in the outpatient setting if you think that's on.

Number that can move up significantly in the near term. Thanks.

Yeah.

Hey, good morning, Vikram. So I'll take the first question on car two two cohort and up question and then my colleagues will probably answer on the second.

Or <unk> cohort and that as a reminder.

We enrolled a total of roughly 50 patients in cohort UNF and these are newly diagnosed multiple myeloma patients.

So we're not providing any guidance, but at this point I think the early timing and what we have reported data probably will be towards the end of this year and as you know Vikram. We always report data at major medical conferences. So that's what we can say about timing or cohort yet.

Yes, yes.

Yeah. The outpatient metric is an important metric, especially as we stand into earlier lines with much larger patient population. So to the question about what's causing the increase I mean, there's a number of things that are driving outpatient use in that stage. One as I mentioned just around volume itself. Our sites are recognizing the fact that they.

They need to look at other options other than admitting patients into their into their hospital in terms of what are we assuming I mean like you said we are at a 30 share today roughly thereabouts I think we could easily double that.

Thank you.

The issue of rate limit around the doubling of the outpatient.

Eric will be largely on our ability to get product into the market with very clear with our sites.

Are sites that have been with us since the very beginning.

Have much much higher outpatient uses or rates of 30%.

As new sites come onboard and were hoping to get pushing to around 100 this year.

I just need to have patient reps quite frankly to ensure that what youre seeing in the verbal setting from a safety perspective is consistent to that of the label. So it's really right now just a matter of getting products into the hands of physicians and allowing them to use this drug to get comfortable with it and then I'll also put the necessary infrastructure that they need to put.

In place for outpatient use.

Very helpful. Thank you.

Sure.

Thank you. Our next question comes from cost of Polaris with BMO capital markets. Your line is open.

Thanks for taking our questions and congrats on the progress a couple of questions from us. So the first one is around the 10000 slots by year end 2025, which is great to see again I'm wondering how should we be thinking beyond 2026 is that any saturation.

Of the slots you can produce audio can potentially even double this 10000 slots that you are guiding in the pure Teddy Betty do not supply and the second question is on coffee to support data if I recall correctly last year you showed that during the breeding face they've got Vicki item had.

More events on the stand out of cat items, although both items were in.

I understand that a cat.

I recall that there was no really any characteristic between the two populations that good.

Playing defense I'm wondering if there is any update.

On these fronts. Thank you.

Okay.

Hey, good morning, this is Ian.

I'll take your question. So on the first one regarding the 10000 lots by end of 2025.

Obviously, we and our partner Jan do you have plans to extend beyond that 10000 of capacity.

Because we do see that there will be quite significantly men one side of the drugs approved in second line and beyond so.

So I would say we cannot provide any specific guidance.

Each year, but I can tell you given the roughly $1 billion of Capex program, we are conducting now.

Think with certain incremental investment, we can actually get to.

A larger number.

In the near future. After about 2026 now of course, there is a limit of what we can do with this current round of Capex. So.

When our partner already are thinking about the next step in fact, the musician could potentially be made this year in 2020, as well where do we need to conduct another round.

Capex or not at all it depends on obviously, a regulatory approvals and also the.

Market assessment based on the feedback from the physicians. So we do surveys of physicians from time to time based on latest clinical data and also the competitive landscape and you guys can't stay tuned on our Capex next year.

On your second question on the initial imbalance of PFS events in the first couple of months when both arm of the cartoon for patients are receiving exactly the same.

Either bridging therapy on the Auryxia arm or the standard of care in the control arm.

We and our partner have tried exhaustively to look at all the subgroup analysis and also a baseline characteristics and in fact, our cost I can assure you that that was a question from regulators because we did have the <unk> meeting.

<unk>.

When <unk> conducted that committee to look at cardiac flooded and now it's a key question. So.

I can tell you that after the exhaustive analysis. The only thing we found was that there is a slight imbalance on the dosing density for a couple of standard of care regimens, including from dose difference in palm lift and then some dose difference in our pocket and you guys will see that on the briefing book.

I think I believe that will be published on a Wednesday. So thats. The only difference we could obviously now does that difference in dose intensity of a permanent or Velcade account for the imbalance in the first couple of months. Unfortunately post hoc analysis, it's difficult to conclude that but that's pretty much. The only thing we could find out.

And that is also why after looking at all the data at.

As you see we did receive a very clean label from Marci HMP recommendation right. If you look at the document you said that correct is recommended for second line treatment of <unk>.

On myeloma after patient has received the one item treatment, adding through an image and also appropriate dividend and also the patients are refractory to revlimid.

Exactly the enrollment criteria for cartoon NASA clean naval we got from from Europe. So that hopefully that gives you a hint. Thank you.

Super helpful. Thank you.

Thank you. Our next question comes from Ashwin <unk> with UBS. Your line is open.

Hi, Thanks for taking our questions. So.

And those are the best to get to 10000 annual doses exiting 2025 by our math you'll need.

Scott expansion of dropping 20% every six months.

To get to those levels does that align with your thinking and then how much of the 10000 doses are you expecting Europe to contribute so that that's one and then secondly can you can you comment on the European pricing in the long run would it trend.

Trend more towards a U S pricing is or is there any different dynamic at play there.

Thanks.

Maybe I'll take the last question.

First one on converting.

On the manufacturing question.

Yes in terms of the European pricing Youre going to see some guidance coming out shortly related to Germany or pricing.

I would expect to see that by the end of the month, possibly going into the early part of April.

Say tuned on that.

You want to talk about the manufacturing, yes. So let me talk about how we plan to get to that 10000 number by end of FY 'twenty five.

First of all we have.

Three internal nodes right.

And like I mentioned earlier in this call we already got too.

Increases in capacity and we're planning something similar this year and we will continue to do that.

25, <unk>, that's part of that but beyond that we are.

Ginger are doing actually the physical expansion of the router.

Essentially after this physical construction is down this year in 2020, we're doubling our effective area of manufacturing and the router side. So that will also figure into the capacity increase in the year of 2025, because once the physical construction is down this year, we'll spend months installing the equipment training.

That and then get all the suites validated on the current bridge MTF vendor. So thats an important part of the railroad increase right and then let's talk about the two other notes in Belgium.

So the first one is called <unk>, which is a stand alone beauty released that started clinical batch production in January and our plans to bring that tie to our commercial production for European demand by end of this year.

What the end of this year, we're up another commercial note at Dunkin' and then the much larger facility called <unk>.

Which is roughly 240000 square foot by design.

The physical construction will be done by end of this year. So our plan is to bring that tech lab facility to clinical production early next year and again in the second half of 2025 that tech client facility will enter into commercial production mode. So those are the three internal nodes and those are very important cornerstone strategy.

How we can get you that has not beyond that you guys. All know we executed a three way agreement with Novartis last year. It was four three year clinical supply right now we're expecting novartis to file for <unk> potentially first half of this year not that that pending FDA approval.

Novartis will start to produce clinical trial material for us.

So that external CMO strategy is often important pillar of our strategy to get to that 10000, so honest combined.

End of 2025, we're on track at this point to get to that $10000 annual capacity.

Thank you.

Oh and last I think as you asked about the revenue split obviously its way too early for us to comment because Ryan up whatever revenue, we generate for corrective from Europe, it's really by allocation because there's only so much capacity, we could allocate to Europe.

Yes.

And then in the future once we have enough capacity to satisfy demand from both the U S and European demand Danny if you look at some of the prior car T.

The revenue split it's usually roughly maybe 50 50 slightly favoring the U S.

And then the <unk>.

Especially the European revenues, just shy of 50%. So we think that should be the same dynamic for <unk> car T in myeloma.

Thank you. Our next question comes from Edward 10th off with Piper Sandler Your line is open.

Great. Thank you very much for taking my question and I appreciate all the good color the update today Cologuard tunnel.

Progress. So my question really has to do with.

Kind of second line plus utilization.

How do you envision.

Physicians prioritizing patients assuming that label expansion do you think that we'll see.

Perfect to use move earlier line as evidenced by the superior results that we saw from Carter to four.

Is it really going to be up to the site how they're allocating.

Correct.

Any color on your early thoughts on that would be appreciated. Thank you.

Yes, why don't I take that since we we just have some data readout specific to that question.

If you step back and look at the myeloma population segmented by standard risk versus high risk.

That's how we do it and if you assume that of the high risk population. They represent about 25% of the total and that's pretty consistent across all lines of therapy.

What our data is showing.

We ran some research right after last year's Aska won't release, this data and we actually just reran. It recently and some fairly consistent so based upon the results that English shared earlier in terms of our quarter two or data.

We're seeing for sure that 20% to 25% high risk group.

Moving over a physician is going through very quickly with the with car T therapy like <unk> cel up front and second line and then we're also seeing and this was a bit of a change which was a positive change for patients is yes with even within the standard risk population of physicians have said that they see them moving forward with.

Our victory in standard risk in second line, plus Fox that population as well.

So that's quite exciting as you know thats quite a sizable patient population for us.

But that data like I said is fairly fresh now we've just said that readout here in the first quarter.

I guess lastly, maybe tidbit of information if this real quickly.

The new dynamic that this launch represents as a referral dynamics, especially in the standard risk group.

As opposed to recorded Q1 launch, which was pretty much most of those with one plus patients were already within our hospitals.

Through our partner and our partners fully staffed trained up and ready to go.

There'll be pushing from a referral upfront in the outpatient setting where most of the standard risk patients are today to refer those patients that are car T eligible to our site. So that's the only I would say added wrinkle to that second line plus indication is really this active engagement in terms of referrals from the outpatient clinics into a hospital.

Great Super helpful color I appreciate it and good luck this week.

Thank you.

Thank you. Our next question comes from Justin Zealand with BTG. Your line is open.

Thanks for taking my question and congrats on the progress. So I wanted to ask if you could give us some update on the out of spec rate that you're seeing and your confidence on the fda's widening of the out of spec window with the most recent submission.

Hey, Justin Thanks for the question. So I think what I can say is that in a lot my amongst all three quarter also the Arctic.

Spec grade has been quite stable.

We mentioned it's in the teens range. So at this point that we are seeing very stable trend of OS and the next leg up would be.

Pending FDA approval, we hope, we'll get a wider release back and then we hope to have another significant reduction in the August back right now regarding the FDA approval. So as you know Justin we did submit it in the supplemental BLA in June of last year asking FDA.

To widen our release back based on the clinic.

Clinical data we received from credit Suisse for data. So we provided a wealth of <unk>.

Recall, the sensitivity analysis by correlating the release back with clinical outcome.

At this point.

We are still confident that we should be able to receive the wider effect.

But we don't comment on detailed interaction with the agency you're going to have to wait and see when we received.

FDA approval Danville.

Well I'll, let you guys know what kind of.

Regulatory action the agency has taken thank you.

Thanks for taking my questions.

Thank you. Our next question comes from Mitchell Kapoor with H C. Wainwright Your line is open.

Everyone. Thanks for taking the questions I have two the first one is.

Kind of on the strategy of moving into earlier lines, knowing that you will undoubtedly treat patients who would have otherwise been treated in the later line setting can you kind of help us contextualize the true additional expansion opportunity of moving into earlier lines and then the second is on the strategy of the Salesforce messaging, assuming a new approval.

In the earlier line settings.

With new accounts.

You expect asset position to potentially put patients on <unk>. In later lines first and then move to earlier lines or would you initially asked them.

To begin locations in earlier line settings.

Yes, I think as Steve Thanks for that question. It's a good one so so we will be obviously be in launch mode with part of Q4. So we will be messaging hard obviously, the new indications second line plus nature of it and all the patients that meet the eligibility criteria. So we will be really from a messaging perspective really dominating.

<unk> four in second line plus.

As far as the eligible patient population I think actually give you. Some numbers here that may help you and these are folks who have patients. These are global numbers that meet the eligibility criteria not necessarily accretive population, but at least for those patients that are eligible. This may help with some of your math and your modeling so in the frontline setting. This is a global number we foresee about a 22.

Patient opportunity globally policy for us by the tripling of that moving to 60000 by about 28006 around around the same number 2020 to 28000.

So hopefully that will give you some perspective in terms of an incremental impact as we go into earlier lines.

Great. Thank you.

Got it.

Thank you. Our next question comes from George Farmer with Scotiabank. Your line is open.

Hi, Good morning, Thanks for taking my questions you guys mentioned.

80% market share.

Perfect.

In multiple myeloma versus effect can.

Can you comment on what's driving that decision for physicians.

To use a back might even in the first place and do you think that can improve and then second question. Maybe I missed this are you still guiding for profitability in 2026.

Hi, This is Steve again, we got a little mechanical difficulty on online could you repeat that first question I think the question was related to our Beckman Beckman use yes.

Yeah. So you guys said you had about 80% market share.

<unk>.

Right and just like wondering what's driving that decision to even use it back Max do you think and overcome victim can you improve upon that and then the second question has to do with that.

Profitability in 2026 or is that still.

Message you guys are communicating.

Sure Al.

I'll take the first one.

Okay.

We are reconnected now.

Alright, guys, rather than Wi Fi across when I got here.

Can you guys hear me Okay on your end.

Yes, Okay. Okay. I think the first question has to do with once again at Beckman juice and why even bother using it back but I think what's happening here and this is a research now speaking is there still a large number of patients in the supply and setting that we just quite frankly can't satisfy yet.

So therefore, thankfully theres other car T therapy available and Youre seeing a best in disease in that setting it's quite that simple. The other thing to think about and we in the United States. We don't have marrying sure territories, where commercial map so to speak where not all identical centers. So in some centers.

Baxter is obviously the only car T. In towns are going to get it back book, but that doesn't happen very frequently so that is the other area, where you might see some effect for us just in terms of our commercial footprint.

Or even talk about processor. So the messaging is still consistent with profitability in 2026.

We've talked in operating profitability could be CMA program. The sandy critical there is their penetration into earlier lines of therapy and kind of uptake on our revenues will continue to drive our cost down and then the other component of that is really I talked about earlier is pipeline advancement so by 2026.

We're projecting that we can break even or be profitable from an overall company perspective.

Great. Thanks very much.

Thank you. Our next question comes from Gena Wang with Barclays. Your line is open.

Thank you for taking my questions sorry.

Sorry, I'll Darling late so apologizes those questions already been asked.

So our first question is regarding I think you mentioned that in the past by the end of 2025 yield capacity can reach 10000 doses and what would take for you to reach 20 to 25000 doses and how long would that take and then second question is regarding <unk>.

Dirk.

Later this week.

So.

Maybe if you can share like what kind of data you submit to the FDA and do you expect some discussion regarding the toxic.

Toxicity profile, such as a neurotoxin.

Hey, Good morning. This is the I'll take your question.

<unk>.

On the first one.

I think.

Covenants previously that with this current around the very extensive.

Capital investment between Us and our R&R J&J, we think we can go beyond that 10000 and potentially go to the numbers you quoted.

It will take some incremental investments and it will take probably another couple of years to get there but at this point.

I'd, rather not share any details around that just suffice to say that yes. We will go beyond 10000 with this current round of Capex and also potentially help from our external partners.

So that's the answer for your question. The first question and then the second one regarding or that.

I can tell you that it's very clear from the FDA communication and writing and also very body that the focus of the Odessa will be discussed.

Discussing the overall survival benefit <unk> provides in this patient population you value targets.

How did you what study and in the context of some early imbalance, which you have seen from the PFS curve rate. So that's really the focus of all of that here.

In terms of.

What they're focusing on now I'm sure.

For our <unk> session.

Daniel.

Meeting they always talk about the overall range.

And that probably will touch upon some of the adverse events, including.

Crs neuro tox.

Second primary malignancies, but.

Like I mentioned again.

The survival, it's a focus.

I will benefit is the focus.

Not the SPM issue or a neurotoxin issue at this point based on what we heard from FDA. Thank you.

Thank you. Our next question comes from Kelsey Goodwin with Guggenheim. Your line is open.

Oh, Hey, good morning, Thanks for taking my questions.

First I guess.

How should we think about the first quarter 'twenty for sale given kind of the step up in the back half of 'twenty, three and likely not being fully recognized events the fourth quarter sales that we saw.

And then secondly on the AD comps.

So given both are on the same day and crossover is obviously our main focus could you remind us the rationale for not allowing crossover and part of Q4 and do you think that that might be a hang up for the FDA in any way. Thank you.

So quarter over quarter growth.

We're not giving specific guidance, but I can tell you, we do anticipate whatever quarter growth, it's more pronounced breath in the second half of the year with anticipated launches in the second line setting.

Yeah.

Sure. So thank you for the question calcium as you know there is some difference between the two trials.

And in the cartoon fast study, we did not allow crossover which means we did not provide the patients who progressed all the standards.

Sure.

To cross over into <unk>.

Okay.

However, once the patient.

<unk> instead of a chore they can actually get any commercially available therapy, including the two commercially available car T therapies and also the commercially available.

By specifics and also they can enroll into clinical trials. So youll see some of the details on Wednesday, when the briefing book comes out what those subsequent therapies those patient receive but I can tell you. Yes. There are patients who did receive car T therapies after.

After progression.

So that's.

Now on the other hand.

Even though we did not allow the crossover but.

Before we started enrolling patients we actually had a very frequent communication with both FDA.

Yes, I may add to global regulators to talk about the protocol of car two to four including the.

Not align a crossover design so.

At this point I don't think that will be a.

Big focus of debate here at all of that.

Perfect. Okay. Thank you so much.

Yeah.

That's all the questions we have for today. Thank you for your participation you may now disconnect everyone have a great day.

No.

Okay.

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Okay.

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Yes.

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Earnings call at this time, all participants are in a listen only mode.

Later, we will conduct a question and answer session and instructions will be given at that time.

As a reminder, this call is being recorded.

And I like to hand, the call over to Jessie Young head of Investor Relations and public relations you may begin.

Good morning. This is Jessie young head of Investor Relations and public relations at legend biotech.

Thank you for joining our conference call today to review, our fourth quarter and full year 2023 kopelman.

Joining me on today's call are getting Wang the company's Chief Executive Officer, and Molly Mccumber, the company's Chief Financial Officer.

Following the prepared remarks, we will open up the call for a Q&A, we have called Wei fan Chief Scientific Officer, and Steve Gaffle head of commercial development for the U S and Europe churning the Q&A session.

Joined today's call, we will be making forward looking statements, which are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied here with.

These forward looking statements are discussed in greater detail in our SEC filings.

We encourage you to read and can be found under the investors section of our company website.

I will now turn the call over to Iain.

Good morning, everyone. We're glad you could join US today, because a lot has happened since our last earnings call.

First we're excited at the prospect of bringing our leap therapy convicted to more multiple myeloma patients in Europe.

As many of you have heard Kovykta you received a positive opinion from the committee for medicinal products for human use to expand into earlier lines of treatment.

<unk> is the first car T therapy to receive a positive <unk> opinion in the second line setting for patients with relapsed and Atlanta, They don't mind refractory multiple myeloma.

The formal European Commission decision is expected in April.

As for the approval of convicted in the United States in the second line. We are scheduled to meet with the Fda's Oncologic drugs Advisory Committee. This Friday.

The 15th to answer any outstanding questions. They have we are preparing for a potential launch in this expanded indication on the <unk> date of April 5th and we will of course keep you posted.

Now I'd like to turn to other achievements and activities since our last earnings call.

Our work to bring <unk> to more patients globally resulted in total net sales for the fourth quarter of 2023 of $159 million for.

For the full year total sales for correct you were half a billion dollars.

The increase in our fourth quarter performance versus the third quarter was a result of the ongoing launch of car victory and share again from capacity expansion and manufacturing efficiencies.

We have now been in the market for seven full quarters, and we are the fastest launch to car T therapy.

We anticipate continued quarter over quarter growth throughout 2024 as well.

We believe our cash balance of $1 3 billion provides us with financial runway through the end of 2025.

In order to serve more patients and meet our revenue targets, we have expanded our supply of lengthy viral vector significantly through a large reactor in Switzerland operated by our partner Jonathan Johnson. In addition, Johnson <unk> Johnson has another factory under construction in.

The Netherlands.

We also continued to expand our internal manufacturing capacity in partnership with Janssen.

Our cell processing side in Ghent, Belgium called <unk> produced the first batches of corrective for clinical use in January 2024, we.

We hope to start commercial production in the second half of the year.

Construction progressed on our second manufacturing site Tech land in Belgium, and is expected to be complete at the end of the year.

We have increased capacity at our Raritan, New Jersey facility doubling cell processing capacity since the beginning of 2023.

The increases to our production capacity will help ensure we meet our target of supplying corrected to 10000 patients by the end of 2025.

I am excited to announce we have a new bedroom leader with more than 25 years of experience now overseeing our manufacturing sites are own Burke vendor wind has been promoted to senior Vice President global manufacturing and technical operations.

Our previous head of global Tech off lease Cosan has stepped aside from full time work for personal reasons and is now serving as a senior advisor for us.

Burke joined US in 2021 to start our European organization in the manufacturing facilities I just mentioned the site in against that is just can't online and second one under construction.

Before joining legend he served at Janssen Teva and Astrazeneca.

<unk> has earned the trust and respect of our global manufacturing teams and he has already made a big impact.

The increase in production capacity, enabling us to meet growing patient demand comes in parallel with new data, we presented at the American Society of Hematology meeting in December.

In an oral presentation, we unveiled data showing improvements in patient outcomes as early as second line treatment in our pivotal phase III <unk> study.

The results demonstrated clinically meaningful improvements in health related quality of life measures and reductions in symptoms following treatment with <unk> compared to standard of care.

In other news from the fourth quarter, we continue to bring more hospitals online and we now have a total of 65 U S hospitals certified to treat with car victory patients.

Additionally, about 30% of patients are now administered.

Administered in the outpatient setting.

Turning to the pipeline, we're investigating the potential of our cell therapies in blood cancers beyond multiple myeloma and also in solid tumors.

We have started dosing patients in our D. O L. Three targeted program the phase one clinical trial <unk> 210 to in lung cancer.

Dr Marine using <unk> zero two can also be deployed in other pipeline programs if validated in the clinic.

After phase one novartis will takeover and conduct any further development, including manufacturing and commercial activities.

To sum up 2023, we closed the year with accomplishments on several fronts now I would like to turn the call over to Laura to walk you through the financials for 2023, sorry.

Thank you <unk> and good morning, everyone as Ian mentioned, we generated approximately $159 million in total net sales for <unk> during the fourth quarter, an increase of 189% year over year driven by the progress we have made.

With ongoing market launches expanding market share and capacity improvements as.

As a reminder, we share equally in all profits and losses occur Vickie ex China with our partner Johnson.

Turning to our revenue total revenues for the fourth quarter were $79 5 million consisting almost entirely of collaboration revenue from the cello her victory.

Net loss for the quarter ended December 31, 2023 was 144 8 million or a loss of <unk> 40 per share compared to a net loss of $135 9 million or a loss of 41 per share for the same period last year.

For the year ended December 31, 2023, net loss was $518 3 million or a loss.

Loss of $1 47 per share compared to a net loss of $446 3 million or a loss of $1 40 per share for the year ended December 31 2022.

Moving on to expenses collaboration cost of revenue for the fourth quarter 2023 was $32 5 million compared to 23 million for the same period last year.

These are lessons portion of collaboration cost of sales in connection with the collaboration revenue under the option agreement along with expenditures to support the manufacturing capacity expansion.

Research and development expenses for the fourth quarter 2023.

$105 7 million compared to $80 8 million for the same period last year.

The increase of $24 9 million for the three months ended December 31, 2023 compared to three months ended December 31 2022.

Due to primarily due to continuous research and development activities and set to sell including higher patient enrollment for phase III clinical trials for CIT to sell and an increase in research and development activities for other pipeline items.

Administrative expenses for three months ended December 31, 2023, or $28 7 million compared to $26 7 million for the same period last year.

The increase of $2 million year over year is primarily due to the expansion of administrative functions to <unk>.

Silicate continuous business growth and continued investment in building legend biotech global information technology infrastructure.

Selling and distribution expense for three months ended December 31, 2023 was $33 7 million compared to $25 8 million for the same period last year, the increase of $7 9 million year over year due to costs associated with the commercialization of <unk>.

To summarize our spending remains on track and we continue to maintain a strong balance sheet as of December 31, we had $1 3 billion in cash and equivalents deposits and investments. Additionally, as we enter the new year, we received $100 million upfront payment in early January and connection.

With our global license agreement with Novartis for certain car T therapies targeting D. L. Three.

Thus, we believe we have sufficient capital to fund, our operating and capital expenditures through the end of 2025.

Thank you I'll now pass it back to Ian for closing remarks.

Thank you Laurie 2023 was an impressive year for legend carve it has proven to be the fastest launched car T therapy. The achievements of our global teams have set us up for great success in 2024, and we're poised to provide more therapy to even more patients around the world.

I want to thank each of our 1900 employees for their commitment and dedication to legend and with that we'd like to take your questions.

Operator, we're ready for the first question.

Thank you.

I'd like to ask a question. Please press star one one question has been answered and you'd like to remove yourself from the queue. Please press star one again.

Our first question comes from Jessica Fye with Jpmorgan. Your line is open.

Great. Good morning, Thanks for taking my questions a question on supply and I. Appreciate the color on prepared remarks, and you put the year end 'twenty five target out there for 10000 doses do you have a year end 'twenty four target you could share and if not I guess, what's the right way to think about for example, the.

<unk> step ups youre going to ask the FDA to grant this year. Thank you.

Hey, Jeff.

Thank you for the question about manufacturing so I'll take that one.

We did mention is beginning of last year that our goal is to provide micro both IL 10000 doses a year when we exit 2025.

Beyond that we're not providing any guidance on 2024 manufacturing scale up.

I can tell you that just as you look at last year.

<unk> applied for FDA approval for two capacity increases and archive and buyer to New Jersey, and we did successfully achieved both approval from FDA.

This year. Our plan is the same that is we are an additional two capacity increases that we plan to request the FDA.

So that's the same cadence as last year.

That's our plan for 2024.

Thanks.

Okay.

Thank you. Our next question comes from Jonathan Miller with Evercore ISI. Your line is open.

Hi, guys. Thanks for taking the question.

I'd like to ask about your early pipeline.

Both.

Beyond <unk> three in that in that armored car, what can investors look forward to it and even if you are not specifying targets can you give us a little bit of color about whether the your choices are likely to be familiar to folks will be familiar targets or these are new new places to go looking for call and then separately.

Do you have any plans to get into the autoimmune space like so many of our other peers.

Thanks, Jonathan This is bothering the question yeah. So on the pocket of from some of our pipeline targets.

Among others our novel I, probably can provide some high level thinking about where we are having.

Hello, Patrick.

I'll have a few.

Apologies for US is to really try to do the nonmedical, whom our franchise, especially for patients post treatment.

That space is ad targeting.

Im a little pocket as well now currently as a research and development, while you see a fairly diverse platform boots.

Yes.

Second apology will have these vessels.

We see this is emerging areas of the screen.

Opportunities.

In this space I would say the differentiated approach is critical our internal focus is at this point in time with energy.

And we also.

Have a program office space by really focusing on the differentiation.

Focusing on that.

This is approach can lead to the patient prescreening through the tool.

We also have some investment in solid tumor space.

Focusing on some of the key.

Hurdles associated with disease the disease.

These peso for example.

<unk> expression is generic.

Not only is through a company associated with the us start with the trade War.

Casey, which is the major limitation.

The ratio.

From.

Turning to our full yet so.

The key.

Key technological innovation to address.

Ill.

Solid tumor targeting.

She and hope to generate a bystander.

The toxicity, and therefore being able to extend it.

TFS.

Benefit to after treatment with <unk>.

This revenue will be just the high level.

Thank you for your question.

Thanks, So much and then one follow up if I may I noticed your burn here at about $103 million a quarter looks like you're not.

Runway guidance to end of 'twenty, five seems like Youre not guiding for a lot of improvement in burn rate or any improvements in <unk>.

Revenue was offset by a corresponding increases in spend.

Is that a fair way to think about it.

That's correct if you take a look.

<unk> been conservative Democratic.

Primarily through the end of.

It's really going to be dependent upon our pipeline into our pipeline of answers, but we do believe as it stands today.

With our cash balance.

Our ability to form a program.

Thank you so much.

Okay.

Thank you. Our next question comes from <unk> Chen with Goldman Sachs. Your line is open.

Thank you for taking my questions.

And for.

For the upcoming <unk> meeting on Friday, So could you share a bit more about the cutoff date for those data could potentially share with the committee and also follow On's data for the <unk> treated group, who was shared in 2023, ash, which showed a very strong or better fair compared to intent to treat group.

So, we'll discuss including as trader group as well, so which Google will likely to be more important.

Per your previous communication with the regulators.

And also we're trying to understand about your initial thoughts on the Europe European countries launches, so any incremental updates on the launch and any preliminary strategy on that thank you.

Casey This is Ian I'll take your first question around <unk>. So.

At this point I can tell you we submitted three data cuts to the FDA and also overall survival because we were told by the FDA that we focus on the upcoming OTA alcohol March 15th will be overall survival. So as you mentioned the first data was submitted in the BLA in June of last year and that was part of the.

First <unk>.

Specified interim analysis with a data cut on November <unk> 2022.

And then as part of the day, one funding safety update we submitted to the FDA in October of last year, we put in another update on survival from Khartoum before that with the data cutoff April of last year and then most recently on January seven we submitted latest survival data from parts.

With a data cutoff December 13th of 2023. So those are the three different overall survival analysis, we provided to the FDA and those are three data that will be discussed on Friday biotech as well.

In terms of ITT versus.

I can tell you that all our data analysis.

Survival benefit was provided on the basis of intention to treat ITT and that is the all cause mortality analysis, which is the most conservative scenario here.

Not planned to submit to the agency the data off of viable on the basis.

So I hope that answers your question about the <unk> and then I'll ask my colleague Steve to comment on the European launch given the most recent DHS. The opinion, yes. Thanks, a couple of things just to remind the listeners that our partner is responsible.

Our victories launch planning outside of the United States.

And with exception of China.

As far as Europe goes.

As Jim mentioned.

Maybe I don't think you did mentioned we are currently in Germany.

Our victory as well as Austria, and Austria came onboard in December of last year. The intention and this is through a partner or partners in active negotiations currently around our new <unk> four data. So in terms of guiding in terms of the country launch planning, we don't have anything yet to guide because I know this is a pretty fluid environment.

Right now with the agencies in Europe, and our partners unfortunate I can't guide you at this point in time.

Okay.

Got it thank you Yang MST.

Thank you. Our next question comes from Yaron Werber with TD Cowen Your line is open.

Hi. This is gena honestly is Alan thanks for taking our question I kind of wanted to ask about parkinsonism, which is seen more convicted and other car Ts why do you think when we think uniquely produces parkinsonism, although we spoke to paywall at that that it can have pretty irreversible effects. So do you think at this point to deter Houston earlier line setting, especially as competing.

Don't show this.

Thanks.

Hey, Dan.

This is <unk> I'll take your question on Proteus owner, well first of all if you look at the data that's both in clinical trials and also from the FDA AUR database.

This phenomenon.

Pakistan is not unique oncology in fact, it was reported from patients who are taking <unk>, Kim Ryan and <unk> and so far.

As.

As of end of last year, we could see about seven cases reported in the FDA database from the U S patient. So that's the number that's actually the facts.

With regard to why our team just kind of delayed parties on it I will say, there's a couple of hypothesis out there.

For example, it could be because of the T cell trafficking into the CNS or new brands when the patient had the leaky blood brain barrier after years of therapy or.

Or is the patient already had preexisting argued situations such as a neuropathy so that could be one of the our hypothesis. Although at this point I don't think Theres any started clinical evidence to show, which is the root cause of our pocket.

Regarding your question on Parkins donors in the earlier lines as we reported <unk> <unk>.

Given the <unk>.

Risk mitigation strategies, we implemented following the 6K to reporting from our Q1, we were able to show that the incidents of Parkinson's was going down from about 6% and car to one to about 0.5% new cartoons for that was.

One case, we reported at <unk>.

So we believe that if you look at the earlier line patient population because of the risk mitigation and also potentially because of the patient baseline difference. We think that is entirely manageable a phenomena here. Thank you.

Thank you. Our next question comes from Kelly <unk> with Jefferies. Your line is open.

Okay.

Hi, This is Dave on for Kelly <unk>. Congrats on the progress I have a couple of questions. One is the as the multiple b B C. A major and sort of label now have you received any feedback from physician on how does that position Carr with divorces that those treatment also on sale.

When do you expect to provide.

Sales guidance and although you mentioned J&J will be responsible for all study that any color on when should we expect.

To record the first revenue in other countries in the U S EU and Japan. Thank you.

Yeah.

Why don't I take the last question around sales so.

As far as the EU and Japan, I mentioned that we're already in Austria and Germany.

And unfortunately, because of negotiations being ongoing we cannot comment on what country, maybe in Europe and that includes Japan for that matter.

I think your other question had to do with it.

Selection of victory in terms of patient types.

We're seeing obviously right now within the U S and in Europe.

One offsetting here in the states.

You mentioned in his opening remarks, we're running at about an 80% market share insights where we are.

We are basically competing against the back months. So I think that speaks volumes in terms of preference in terms of physicians and.

All in all risk categories, whether it be standard risk or high risk.

I think where you see some other product use around by specific uses when potentially RBC may not be available.

If the physician wants to bridge to a car T therapy, you are seeing some uptick for sure in the Bispecific space I think that has.

In terms of market erosion, where you are seeing at least in the research that were doing is youre seeing the market erosion occurring with the backbone.

Device specific is used in front of car T therapy as opposed to sopra itself.

Hey, Doug I'll take your first question I think it was long a label update so.

I'll provide us into <unk>.

Number one is that you're all aware that in late last year. We did receive an official label update that includes a two year minimum follow up off the car to the one in.

In late line multiple myeloma with that of <unk>.

It also included label update on Am Al and also Mds, So I want to provide a little bit clarification on this so if you look at the total of 97 patients from car to what we saw nine patients with 10 cases, if you look at accumulative rate.

And we all flash MBS, it's roughly 10% of recall.

This trial was started back in 2019, so essentially in the last five years the accumulated rate of AML Mds is roughly 10% now there is a paper that was published in December.

December of last year, which looked at insurance that same database over 1000 patients were triple exports, which means these patients have been treated with triple causes, including one dropdown amid cost one dropdown potent behavior and then one dropped from fees.

So.

If you look at that patient population.

Any treatment.

<unk> rate of developing Mds or AML, it's roughly 3% each year. Therefore, if you look at the data from Carter, what we don't believe that is actually higher than the background rate and we already got the label update on AML and Mds now regarding the second one as you guys. All saw from the public communication from the FDA asks.

<unk> brands of car T therapies will receive label update all T cell lymphoma, and FDA believes this is a class effect. So everyone will get similar or the same language and right now we and J&J are in discussion with the FDA about exact language off label update for <unk>.

To say that given the 23 cases reported.

From the FDA and also denominated is over 27000 patients who are treated with OTC brands at some mahyco trial patients. It is a small and where risk and we think we'll get the label update in the near future.

You also have a question about.

Feedback from physicians on how they think about <unk> versus other novel therapies I think now.

We have been.

In touch with the physicians and care often saw ash and at this point, we have nausea, and new prescription behavior that has changed.

Based on the.

T cell lymphoma, or <unk>, a label change and if you look at efficacy.

Physicians continue to believe that <unk> provides best in class efficacy with nearly three years PFS late line and then also again as you saw the results from cartoon for compared to standard of care, such as <unk> Select Farmington Bank in Mexico, we saw a 74% risk reduction in progression on debt and <unk>.

We'll see you on Friday, and how <unk> has helped those patients with the buybacks as well so at this point.

I think it's still positioned as best in class efficacy with a onetime injection convenience that is how physicians view perfect. Thank you.

Thank you.

Thank you. Our next question comes from Liana <unk> with RBC capital markets. Your line is open.

Hi, yes. Thanks for taking my question I also wanted to ask on the <unk> and I guess, specifically, how you're thinking about competitive implications coming out of that meeting I guess with regards to the drug youre going to be sharing a committee with do you think any setbacks for them are going to be a positive for you is there is less markets building potentially less competition or do you think if they succeed.

It's going to be helpful. Given that they can drive greater awareness and I guess is there any risk of the car T space broadly being painted with the same brush depending on.

Yes competitor present.

Thanks, Joe for the question.

So I think if you look at the <unk>.

Federal Register fabrication, you will see even though it's the same roster of all of that but it's actually two different panels on the morning of March 15th or <unk>.

We'll discuss the applications from us on the second line indication for <unk> and then in the afternoon.

Same old aircraft or.

Allison experts will discuss the application from competition in a third line application.

So I think it is a separate panel, it's not necessarily a panel on a car class and I believe each application will be discussed and also.

Debated by the tail end of the agency on its merits.

So I can't comment on our competition.

Applications of the data, but we firmly believe that <unk> provides overwhelming benefit or.

In the PFS and also overall survival endpoints here so.

What we can say about this and if.

If you look at car T as a cost in general in late line multiple myeloma.

Clearly the class of therapy has provided a new option for patients who are treated will be treated and also failed all major classes, including an image a probably the leader in all phases of the antibody at that point, we faced it really did not have much choice.

Besides the Bcm, Hey, direct agents. So we firmly believe that there is a very important space called <unk> directed car T. In the treatment of multiple myeloma.

Thank you.

Okay.

Thank you. Our next question comes from Vikram <unk> with Morgan Stanley. Your line is open.

Hi, Good morning, Thank you for taking our funds that we had two one on the pipeline and what on commercialization. So on the pipeline for the <unk> two study.

We were just curious what your latest thoughts were on timing for data from cohorts E&S.

And then on commercialization you mentioned that around 30% of patients are administered <unk> in the outpatient setting.

Hi, do you think that could go.

In the near to midterm and what do you think facilitates.

Greater use in the outpatient setting if you think thats a.

A number that can move up significantly in the near term. Thanks.

Okay.

Hey, good morning, Vikram. So I'll take the first question on car two two cohort and question then my colleagues, both avia and <unk>, So <unk> cohort and that as a reminder.

We enrolled.

Roughly 60 patient cohort.

These are newly diagnosed multiple myeloma patients.

We're not providing any guidance, but at this point I think the early timing and where we can report data probably will be towards the end of this year and as you know Vikram. We always report data at major medical conferences. So that's what we can say about hanging or cohort yet.

Yeah. Thanks, Nick Yeah. The outpatient metric is an important metric, especially as we stand into earlier lines with much larger patient population. So to the question about what's causing the increase I mean theres a number of things that are driving outpatient use of United States. One as I mentioned just around volume itself. Our sites are recognizing the fact that they.

They need to look at other options other than admitting.

C patients into their into their hospital in terms of what are we assuming I mean like you said we are at a 30 share today roughly thereabouts I think we could easily double that.

Thank you.

The issue of rate limit around the doubling of the outpatient.

Eric will be largely on our ability to get product into the market with very clear with our sites.

Are sites that have been with us since the very beginning.

They have much much higher outpatient uses or rates of 30%.

As new sites come onboard and were hoping to get pushing to around 100 this year.

I just need to have patient reps quite frankly to ensure that what youre seeing in the <unk> setting, let's safety perspective is consistent to that of the label. So it's really right now just a matter of getting products into the hands of physicians, allowing them to use this drug to get comfortable with it and then I'll also put the necessary infrastructure that they need to put.

In place for outpatient use.

Very helpful. Thank you.

Sure.

Thank you. Our next question comes from cost of Polaris with BMO capital markets. Your line is open.

Of the slots you can produce audio can potentially even double DS 10000 slots that you are guiding in the pure Teddy Betty do not supply and the second question is on constitute forward data if I recall correctly last year you showed that during the briefing face they've got Vicki Adam had.

More events on the standout of cat items, although both items were you understand that of CAD I recall that there was no really any characteristic between the two populations that good explain these different and so I'm wondering if there is any update.

On this front thank you.

Okay.

Hey, everyone comfort.

I'll take your question. So on the first one regarding the 10000 lots by end of 2025.

Obviously, we and our partner Jan do you have plans to extend it beyond that 10000 of capacity.

Because we do see that there will be quite significant demand one side of the drugs approved in the second line and beyond.

So I would say we cannot provide any specific guidance.

Each year, but I can tell you given the roughly $1 billion of Capex program, we are conducting now.

With certain incremental investment, we can actually get to.

A larger number.

In the near future. After about 2026 now of course, there is a limit of what we can do with this current round of Capex. So.

We and our partner already are thinking about the next step in fact, the musician could potentially be made this year in 2020, as well where do we need to conduct another round.

Capex on that it all depends on obviously regulatory approvals and also the market assessment based on the feedback from our physicians. So we do surveys of physicians from time to time based on latest <unk> clinical data and also the competitive landscape and you guys can stay tuned on our Capex next year.

On your second question on the initial imbalance of PFS events in the first couple of months when both arm of the cartoon for patients are receiving exactly the same.

Either bridging therapy on the harvest arm or standard of care in the control arm.

We and our partner have tried exhaustively to look at all these subgroup analysis and also a baseline characteristics and in fact our cost.

I can assure you that that was a question from regulators because we did have the <unk> meeting in February.

When <unk> conducted that committee to look at Cardiome now is a key question. So.

I think I believe that will be published on a Wednesday. So thats. The only difference we could obviously now does that difference in dose intensity of a palm loads are velcade account for the imbalance in the first couple of months. Unfortunately post hoc analysis, it's difficult to include that but thats pretty much the only thing we could find that.

And that is also why after looking at all the data at.

As you see we did receive a very clean label from Marci HMT recommendation right. If you look at the bucket when you said that.

Perfect is recommended for second line treatment.

Myeloma after patients had received one of treatment that includes <unk>.

And also approach the dividend and also the patients are refractory to revlimid.

Exactly the enrollment criteria for cartoon for NASA clean label, we got from from Europe. So that hopefully that gives you a negative thank you.

Super helpful. Thank you.

Thank you. Our next question comes from Ashwin <unk> with UBS. Your line is open.

Hi, Thanks for taking our questions. So.

In terms of the belt to get to 10000 annual losses exiting 2025 by our math you'll need.

Scott expansion of dropping 30% every six months.

Trend more towards a U S pricing is or is there any different dynamic at play there. Thanks.

Yeah, maybe I'll take the first one.

<unk>.

Manufacturing.

Yes in terms of the European pricing Youre going to see some guidance coming out shortly related to Germany pricing.

I would expect to see that by the end of the month, possibly going into the early part of April.

Stay tuned on that.

<unk>.

And if you want to talk about the manufacturing, yes. So let me talk about how we plan to get to that 10000 number by ended up at 525.

First of all we have.

Three internal node right.

And like I mentioned earlier in this call we already got too.

Increases in capacity and we're planning something similar and we'll continue to do that.

25, as well that's part of that but beyond that we have.

Ginger are doing actually the physical expansion of the router side.

Essentially after this physical construction is down this year in 2024, we're doubling our effective area of manufacturing and the router side. So.

So that will also figure into the capacity increase in the year of 2025, because once the physical construction is down this year, we'll spend months installing the equipment training and then get all the suites are validated.

The current <unk> standard so that's an important part of the rarity of increase and then let's talk about the two other notes in Belgium.

The first one is called <unk>, which is a stand alone beauty release that started clinical batch production in January and our plans to bring that to a commercial production for European demand by end of this year.

So towards the end of this year, we'll have another commercial note at Dunkin' and then the much larger facility called <unk>, which is roughly 240000 square foot by design.

The physical construction will be done by end of this year. So our plan is to bring that tech land facility to clinical production early next year and again in the second half of 2025 that Tech plan facility will enter into commercial production mode. So those are the three internal nodes and those are very important cornerstone strategy.

How we can get you that.

Not beyond that you guys. All know we executed a three way agreement with Novartis last year. It was four three year clinical supply Brian now, we're expecting novartis to file for <unk> potentially first half of this year and after that pending FDA approval.

Novartis will start to produce clinical trial material.

So that external CMO strategy is often important pillar of our strategy to get to that 10000, so honest combined.

End of 2025, we're on track at this point to get to that $10000 annual capacity.

Thank you.

Yes.

And then in the future once we have enough capacity to satisfy demand from both the U S and European demand then if you look at some of the prior car T.

Our revenue split it's usually roughly maybe 50 50 slightly favoring the U S.

And then the <unk>.

Especially the European revenues, just shy of 50%. So we think that should be the same dynamic for <unk> car T in myeloma.

Thank you. Our next question comes from Edward 10th off with Piper Sandler Your line is open.

Great. Thank you very much for taking my question and I appreciate all the good color the update today Congrats tunnel.

Progress. So my question really has to do with.

Kind of second line plus utilization.

How do you envision.

Physicians prioritizing patients assuming that label expansion do you think that we'll see.

Perfect to use move earlier line as evidenced by the kind of superior results that we saw from a quarter to four.

Or is it really going to be up to the site how they're allocating.

Correct.

Any color on your early thoughts on that would be appreciated. Thank you.

Yes, why don't I take that since we we just have some data readout specific to that question. So if you step back and look at the myeloma population segmented by standard risk versus high risk.

It's how we do it and assume that of that high risk population. They represent about 25% of the total and that's pretty consistent across all lines of therapy.

Our data is showing.

Ran some research right after last year's Aska won't release, the stay that we actually just reran. It recently and it's been fairly consistent so based upon the results that English shared earlier in terms of according to our data.

We're seeing for sure that 20% to 25% high risk group.

Moving over a physician is going through very quickly with with car T therapy like <unk> cel up front and second line and then we're also seeing and this was a bit of a change which is a positive change for patients is yes with even within the standard risk population of physicians have said that they see them moving forward with.

Vicky and standard risk in second line plus Fox popular.

Population as well so that's quite exciting now as you know thats quite a sizable patient population for us.

But that data like I said is fairly fresh now we've just said that readout here in the first quarter.

I guess the last thing maybe tidbit of information if this real quickly.

The dynamic that this launch represents as a referral dynamics, especially in the standard risk group.

So as opposed to recorded two one launch which was pretty much most of this with one plus patients were already within our hospitals.

Through our partner and our partner is fully staffed trained up and ready to go.

There'll be pushing from a referral upfront in the outpatient setting where most of the standard risk patients are today to refer those patients that are car T eligible to our sites. So that's the only I would say added wrinkle to that second line plus indication is really this active engagement in terms of referrals from the outpatient clinics into a hospital.

Great Super helpful color I appreciate it and good luck this week.

Thank you.

Thank you. Our next question comes from Justin Zealand with BTG. Your line is open.

Hey, Justin Thanks for the question.

I think what I can say is that in a lot my amongst all three quarter also the auto spec grade has been quite stable.

We mentioned it's in the teens range. So at this point, we are seeing a very stable trend of OS and the next leg up would be.

Pending FDA approval, we hope, we'll get a wider release back and then we hope to have another significant.

Reduction in the August back right now regarding the FDA approval. So as you know Justin we did submit it in the supplemental BLA in June of last year, asking us FDA.

To widen our release back based on the clinic.

Clinical data we received from <unk> for data. So we provided a wealth of <unk>.

Recall, the sensitivity analysis by correlating the release back with the clinical outcome.

At this point.

We are still confident that we should be able to receive the wider back.

But we don't comment on detailed interaction with the agency you're going to have to wait and see when we received.

FDA approval Danville.

Well I'll, let you guys know what kind of.

Regulatory action the agencies have taken thank you thanks for taking.

My question.

Thank you. Our next question comes from Mitchell Kapoor with H C. Wainwright Your line is open.

Everyone. Thanks for taking the questions I have two the first one is kind.

<unk> in the earlier line setting.

With new accounts, you expect asset position to potentially put patients on <unk>. In later lines first and then move to earlier lines or would you initially asked them.

To begin their patients in earlier line settings.

Yes, Steve Thanks for that question. It's a good one so so we will be obviously will be in launch mode with fortitude for so we will be messaging hard obviously, the new indications second line plus nature of it and all the patients that meet the eligibility criteria. So we will be really from a messaging perspective really dominating.

And part of Q4 in second line plus.

As far as the eligible patient population I think actually give you. Some numbers here that may help you and these are folks who have patients. These are global numbers that meet the eligibility criteria not necessarily accretive population, but at least for the patients that are eligible. This may help with some of your math and your modeling so in the frontline setting. This is a global number we foresee about its 22.

Patient opportunity globally policy for us by the tripling of that moving to 60000 by about 28006 around around the same number $2820 to 28000.

So hopefully that will give you some perspective in terms of an incremental impact as we go into earlier lines.

Great. Thank you.

You bet.

Thank you. Our next question comes from George Farmer with Scotiabank. Your line is open.

Hi, Good morning, Thanks for taking my questions you guys mentioned.

80% market share.

<unk>.

In multiple myeloma versus affect my can.

Can you comment on what's driving that decision for physicians.

To use a back might even in the first place and do you think that can improve and then second question. Maybe I missed this are you still guiding for profitability in 2026.

Hi, This is Steve again, we got a little mechanical difficulty annoying could you repeat that first question I think the question was related to our beckman back to us.

Yeah. So you guys said you had about 80% market share.

And just like wondering what's driving that decision to even use it back Mark do you think and over cardiac team can you improve upon that and then the second question has to do with that.

Profitability in 2026 is that still.

Message you guys are communicated.

Sure Al.

I'll take the first one.

Yeah.

Okay.

We have reconnected now.

Alright, guys, rather than Wi Fi across when I got here.

And you guys hear me Okay on your end.

Yes, okay. Good Okay. I think the first question has to do with once again at Beckman and why even bother using it back but I think what's happening here and this is a research now speaking is there still a large number of patients in the supply and setting that we just quite frankly can't satisfy yet.

So therefore, thankfully theres another car T therapy available and Youre seeing a that can be used in that setting it's quite that simple. The other thing to think about and we are in.

In the United States, we don't have marrying territories.

Territories, where commercial map, so to speak where not all identical centers. So in some centers, where Baxter is obviously they are the only car T. In towns are going to get it back but that doesn't happen very frequently so that is the other area, where you might see some effect for us just in terms of our commercial footprint.

A difference at all or even talk about processor. So the messaging is still consistent with profitability in 2026.

We've talked in operating profitability for the TMA program is going to be critical there is our penetration into earlier lines of therapy and kind of our uptake on our revenues will continue to drive our cost down and then the other component of that is really I talked about earlier is our pipeline advancement so by 2026.

We are projecting that we can break even or be profitable from an overall company perspective.

Great. Thanks very much.

Thank you. Our next question comes from Gena Wang with Barclays. Your line is open.

Thank you for taking my questions.

L'oreal Darling late so apologize if those questions already been asked.

Our first question is regarding I think you mentioned that in the past by the end of 2025 year capacity can reach 10000 doses and what would take for you to reach 20 to 25000 doses and how long would that take and then second question is regarding <unk>.

Back at that later this week.

So.

Maybe if you can share like what kind of data you submit to the FDA and do you expect.

From a discussion regarding the.

Toxicity profile, such as a neurotoxin.

Hey, Good morning. This is the I'll take your question.

On the first one.

I think.

Covenants previously that with this current round the very extensive.

Capital investment between Us and our R&R J&J, we think we can go beyond that 10000 and potentially go to the numbers you quoted.

It will take some incremental investments and it would take probably another couple of years to get there but at this point.

I'd, rather not share any details around that just suffice to say that yes, we will go beyond <unk>.

With this current round of Capex and also potentially help from our external partners.

So thats the answer for your question. The first part and then the second one regarding <unk>.

I can tell you that it's very clear from the FDA communication and writing and also very body that the focus of the Alaska will be discussed.

Discussing the overall survival benefit perfect you provide in this patient population the value and the target for study and in the context of some early imbalance, which you have seen from the PFS curve rate. So that's really the focus.

Oh that's here.

In terms of.

What they are focusing on now I'm sure.

For our <unk> session.

Annual meeting.

Meeting they always talk about the overall range.

Maybe not.

And that probably will touch upon some of the adverse events, including CRM neuro Tox.

Second primary.

Nancy's, but.

Like I mentioned again.

The survival Easter focus.

Survival benefit is the focus.

Not the <unk>.

SPM issue or neurotoxicity issue at this point based on what we heard from FDA. Thank you.

Thank you. Our next question comes from Kelsey Goodwin with Guggenheim. Your line is open.

Oh, Hey, good morning, Thanks for taking my questions.

First I guess.

How should we think about the first quarter 'twenty four sales given kind of the step up in the back half of 'twenty, three and likely not being fully recognized given the fourth quarter sales that we saw.

And then secondly on the AD comps.

So given both are on the same day and crossover is obviously our main focus could you remind us the rationale for not allowing crossover and credited for and do you think that that might be a hang up for the FDA in any way. Thank you.

So quarter over quarter growth.

We're not giving specific guidance, but I can tell you, we do anticipate quarter over quarter growth, it's more pronounced breath in the second half of the year with anticipated launches in the second line setting.

Yeah.

Sure. So thank you for the question calcium.

No there is.

Some difference between the two trials.

And in the <unk> study, we did not allow crossover which means we did not provide the patients who progressed all the standard of care.

Q plus overdue.

Okay.

However, once the patient.

West is almost every day.

They can actually get any commercially available therapy, including the two commercially available car T therapies and also the commercially available.

<unk> and also they can enroll into clinical trials. So youll see some of the details on Wednesday, when the briefing book comes out what those subsequent therapies those patients receive but I can tell you. Yes, there are patients who did receive car T therapies.

After progression so that that's now on the other hand.

Even though we did not allow the crossover but.

Before we started enrolling patients we actually had a very frequent communication with both FDA.

Global regulators to talk about the protocol of car T before including the.

Not allowing a crossover design so.

At this point I don't think that will be a.

Big focus of debate here at <unk>.

Perfect. Okay. Thank you so much.

That's all the questions we have for today. Thank you for your participation you may now disconnect everyone have a great day.

Q4 2023 Legend Biotech Corporation Earnings Call

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