Q4 2020 Legend Biotech Corp Earnings Call

[music].

Ladies and gentlemen, thank you for standing by and welcome to the <unk>.

Operator: and gentlemen, thank you for standing by, and welcome to the Legend Biotech Report's fourth quarter 2020 financial results. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded, and if you require any further assistance, please press star 0. I would like to hand the conference to your speaker today, Jessie Yeung. Please go ahead, ma'am.

Legend biotech reports fourth quarter 2020 financial results.

At this time all participant lines on the listen only mode. After the speaker presentation. There will be a question and answer session to ask the question. During the session you will need to press star one on your telephone. Please be advised that today's conference is being recorded and if you require any further assistance. Please press star zero I would now like to hand, the conference to speak of today.

Jessie Young please go ahead ma'am.

Good morning, everyone I hope, everyone is safe and healthy.

Jessie Yeung: Good morning everyone. I hope everyone is safe and healthy. Welcome to Legend Biotech's fourth quarter and full year 2020 earnings conference call. This is Jessie Yeung, Head of Corporate Finance and Investor Relations for Legend Biotech. Joining me on today's call is Steven Huang, Chief Executive Officer and Chief Financial Officer of Legend Biotech. A few logistics before we get into the details.

For the legend biotech fourth quarter and full year 'twenty 'twenty conference call.

Jessie young head of corporate finance and Investor Relations for legend biotech funding.

Joining me on today's call is being won Chief Executive Officer, and Chief Financial Officer for legend biotech.

I feel logistics before we get into that detail.

Jessie Yeung: This review is being made available via webcast, accessible through the industrialization session of the Legend Biotech website. Please note that today's presentation includes forward-looking statements. We encourage you to review the cautionary statements regarding the statements in today's presentation, as well as the communist prospectus filed with the SEC on June 8, which identifies certain factors that may cause the communist actual results to differ materially from those projected should one or more of these risks or authorities materialize, or should underlying assumptions prove incorrect. Actual results may vary materially from those described in this presentation. Legend Biotech specifically disclaims any obligation to update any forward-looking statement.

This review is being made available via webcast accessible food.

The impression of the legend biotech website.

Please note that today's presentation includes forward looking statements.

Oh encourage you to refer the cautionary statement regarding the statement in today's presentation.

At the time of these towards that is filed with the SEC on June eight.

Identify certain factors that may cause the company's actual results could differ materially from those projected.

One of them off the risks or uncertainties materialize also on the line.

The assumptions prove incorrect.

What are your thoughts may vary materially from those described in this presentation.

Well I think biotech specifically disclaims any obligation to update any forward looking statements.

Moving to today's agenda, we will be starting with the opening remarks, followed by the financial results and we will do a quick we feel of the Ash 2020 data before the end todays call with the Q&A session.

Jessie Yeung: Moving to today's agenda, we will be starting with opening remarks followed by the financial results. Then we will do a quick review of the ASH 2020 data before we end today's call with a Q&A session. I would now like to turn the conference call over to Ying. Thank you, Jed.

I would now like to turn the conference call for you.

Thank you Jessie and good morning, everyone.

Welcome to our.

The fourth quarter and 2020 of results earnings call for <unk>.

Ying Huang: Thank you, Jessie, and good morning, everyone. Welcome to our fourth quarter in 2020 results earnings call. So before I start, I would like to thank everyone and hope everyone is safe and healthy. Let me begin today's call by reminding you what we do here and why we do what we do here at Legend.

Before I start I would like to thank everyone.

And I hope everyone's safe and healthy.

Let me begin today's call by reminding what.

We do here in the why we do what we do share the legend it is to serve the patients.

Our team of legend biotech worked tirelessly to bring innovative therapies to patients living with debilitating diseases.

I am extremely proud to be a part of the team and grateful for this effort.

Within the fourth quarter of plenty of 'twenty.

We achieved critical milestones.

At the recent Ash 2020 of conference our collaboration partner J&J and legend shared exciting results from the combined phase one b and the phase two of college of the one study of the future film.

Ying Huang: It is to serve the patient. Our team at Legend Biotech works tirelessly to bring innovative therapies to patients living with debilitating diseases. I am extremely proud to be a part of this team and grateful for this effort.

And the investigation of <unk> targeted car T therapy.

Yeah.

The data continued to show a very high overall response rate.

Typically 97% of patients achieved a response.

More importantly, 67% of the patients achieved the stringent complete response at a median follow up of $12 for months.

Ying Huang: Within the fourth quarter of 2020, we achieved critical milestones. At the recent ASH 2020 conference, our collaboration partners J&J and Legend shared exciting results from the combined Phase I-B and Phase II-Cardioid-1 study of the supercell and the investigation of DCMA-targeted CAR-T therapy. The data continue to show a very high overall response rate.

Also in December 2020, we initiated rolling submission of BLA or biologics license application for the U S. FDA frankly with the sale.

The submission is based on results from the pivotal phase <unk> phase II card issued one study that evaluated the efficacy and safety of two of the sale in the treatment of patients with relapsed and refractory multiple myeloma.

We also announced the U S. FDA cleared the IND application for <unk> 109 zero.

Legend biotech investigation autologous car T.

Ying Huang: Specifically, 97% of patients achieved a response. And more importantly, 67% of the patients achieved a stringent complete response at a median follow-up of 12.4 months. Also, in December 2020, we initiated rolling submission of a BLA, or Biologics License Application, to the U.S. FDA for pseudocell. This submission is based on results from the Pivotal Phase 1B, and phase 2, Cartitude 1 studies that evaluated the efficacy and safety of pseudocell in the treatment of patients with relapse and or reflux remarkable myeloma.

Targeting <unk> for for the shaping of the T cell lymphoma.

Given that a substantial portion of patients with peripheral T cell lymphoma, and also the Japan is the T cell lymphoma experience relapse, even with the current treatment options. There remains a high unmet medical need for these patients.

With this R&D Claris, we're planning to initiate the phase one first in human study for <unk> 190, ROA in the United States.

Lastly, we also achieved the designation of accelerated assessment in Europe for the treatment of.

Relapsed and refractory myeloma for fear of the south.

The <unk> committee for medicinal products for for human use in European Medicine agency, except for the request from Janssen.

Accomplished partner for this assessment.

Which means instead of the 210 evaluation days for the evaluation process by May of this accelerated assessment, usually takes the 150 evaluation days.

Now, let's turn it over to the financial results from 2020, and also of fourth quarter 2020.

Ying Huang: We also announced the U.S. FDA cleared the IND application for LB1901, which is Legend Biotech's investigation of autologous CAR T targeting CE4 for the treatment of T-cell lymphoma. Given that a substantial portion of patients with peripheral T-cell lymphoma and also cutaneous T-cell lymphoma experience relapse even with the current treatment offerings, there remains a high unmet medical need for these patients

Our net loss on the <unk> accounting standards in 2020 was about three.

$103 million.

This compared to a loss of $133 million of in 2019.

Loss per share for.

For 2020 was $1 28.

Compared to <unk> 66.

Loss per share for 2019.

And these results were driven mostly by.

Larger team and also a higher number of clinical trials as well as the higher number of clinical trial of patients in our car type of program as of all after cardiac program in China.

In terms of quarter over quarter comparison in.

In the fourth quarter of 2020, our net loss was about $58 million.

That compared to the $64 million loss in the clock for quarter of 2019.

Ying Huang: With this IND clearance, we're planning to initiate a Phase I First-In-Human study for LB190i in the United States. Lastly, we also achieved the designation of accelerated assessment in Europe for the treatment of relapse and reflux myeloma for filter cell. The CHMP, or Committee for Medicinal Products for Human Use, in the European Medicine Agency accepted the request from Jensen. Our collaborative partner for this assessment, which means instead of the 210 evaluation days for the evaluation process by EMA, this accelerated assessment usually takes 150 evaluation days.

Loss per share for the fourth quarter of 2020 with 22.

Compares to 32 cents loss per share in the Q4 of 2019.

And the next slide.

As you can see we continue to push forward with a robust pipeline of next generation cell therapies.

Defense of the Bcm per one for which we are conducting the card of two to one in the U S. The card of two to five cohort phase II.

While.

Globally and also the ongoing phase III randomized active control of the car to the for phase III trials.

In China for conducting the pivotal phase III trial card if I owned one.

Yeah.

Besides the Bcm of program, we're continuing to conduct the phase of our first in human studies studies in China. This includes.

But you are targeting CD 19, CD 22 auto car T for non Hodgkin's lymphoma.

We're targeting CD 33 for all one autocar T for acute leukemia.

Ying Huang: Now let's turn over to the financial results for 2020 and also fourth quarter 2020. Our net loss under IFRS accounting standards in 2020 was about $303 million dollars. This compared to a loss of $133 million dollars in 2019.

And also of CB for targeting T cell lymphoma program.

In the field of allo or allogeneic car T. We're conducting two active phase one studies. The first one is a <unk>.

<unk> 20 of targeting allogeneic car T for non Hodgkin's lymphoma.

The second one is a comment delta be CMA targeting.

T cell program for the treatment of myeloma.

In the solid tumor fields, we're conducting a study for clouding 18.2 targeting autocar <unk> for gastric cancer and pancreatic cancer.

Ying Huang: [inaudible] for 2020 was $1.28, compared to 66 loss per share for 2019. And these results were driven mostly by larger teams and also a higher number of clinical trials, as well as a higher number of clinical trial patients in our CardiTube program, as well as the CardiFan program in China. In terms of a quarter-over-quarter comparison, in the fourth quarter of 2020, our net loss was about $58 million, and that compared to a $64 million loss in the fourth quarter of 2019. Loss per share for the fourth quarter of 2020 was $0.22, compared to 32 cents loss per share in the Q4 of 2019, in the next slide.

In addition, we recently started a phase III study for a mesothelium targeting auto car T for ovarian cancer.

Now I would like to take a moment to highlight some of the clinical data from the car to the one study that was presented recently at the Ash 2020 of conference.

As you can see from the slide the data continues to show a very high overall response rate.

Typically 94 out of the 97 patients enrolled achieved a response.

More importantly, 67% of those patients achieved the stringent the complete response.

The median follow up of 12.4 months with the data cut.

The median progression free survival has not been reached yet.

The study also demonstrated a manageable safety profile for three of the sale at the recommended phase II dose, which is <unk> 70.

75 million cells per kilogram of body weight.

Given that these patients were heavily pretreated.

In fact, the median lines of prior therapy with six we believe these results are really.

Excellent.

As we look into the rest of 2021 in non flow into 2022.

I'd like to discuss the near term target for the company.

In the first half of 2021, we're working with our collaboration partner Janssen Pharmaceuticals.

Initially filed the MAA application with the EMA for through the sale.

Ying Huang: As you can see, we continue to push forward with a robust pipeline of next-generation cell therapies. Besides the BCMA program, for which we're conducting the CARTITUDE I in the U.S., the CARTITUDE II, five-cohort, phase two, trial globally, and also the ongoing Phase 3 randomized active controlled CAR-T4 Phase 3 trials. In China, we're conducting the pivotal phase 2 trial called Cardiff-N1. Besides the BCMA program, we're continuing to conduct the Phase I First in Human Studies AIT studies in China. This includes a dual-targeting CD19, CD22 autocar T4 non-harmful lymphoma, and a dual-targeting CD33, CLR1 autocar T4 acute leukemia.

As I just previously mentioned recently the.

For the EMA accepted a request from Janssen of etc assessment for the marketing application for fear of the film.

We're also planning to file the BLA in China pending discussion with CD for fear of the sell in the second half of this year.

In the United States, which is the most important market for <unk> to sell.

We're targeting FDA approval by end of 2021.

Lastly.

We're planning to initiate the phase I of first in human study for <unk> 190 per euro for the T cell lymphoma in the United States.

Our collaboration partner Channel is also working to file an NDA to the Japan Ministry of Health Labor and welfare policy of the sale in the second half of this year.

In 2022, we're expecting the EMA approval for fear of the sell in European Union.

We're also expecting the CD approval for <unk> in China.

Yeah.

In terms of the data update for fear of to sell I'm pleased to announce that legend biotech in collaboration with Janssen intend.

We intend to present updated data from the constitute the one and cartoon two phase II studies at major medical conferences in 2021.

In addition, legend biotech along with Janssen.

Anticipates to publish the data from the legend to phase one first in human studies in 2021 as a reminder, this phase one study enrolled a total of 74 patients in the phase II study.

Ying Huang: And also a CD4-targeting T-cell lymphoma program. In the field of allo or allogenic CAR-T, we're conducting two active phase one studies. The first one is a CD20 targeting allergenic CAR-T for a non-harmful lymphoma. The second one is a gamma delta BCMA targeting T-Cell Program for the Treatment of Myeloma

And every patient has completed the required for three year for us as of November of 2020.

In the next slide as.

As you can see we of a comprehensive clinical development program for two of the cells in patients with multiple myeloma.

In 2020, we initiated a global phase III study called card to the fall. We also expanded the multi cohort phase II study called the car does you too.

The most recent cohort cohort is enrolling patients with newly diagnosed multiple myeloma for first line myeloma.

Ying Huang: In the solid tumor field, we're conducting a study for Claudine 18.2, targeting autocardi for gastric cancer and pancreatic cancer. In addition, we recently started a phase one study for a mesothelium-targeting autocardi for ovarian cancer. Now I'd like to take a moment to highlight some of the clinical data from the CAR-201 study that was presented recently at the ASH 2020 conference. As you can see from this slide, the data continues to show a very high overall response rate. Specifically, 94 out of the 97 patients enrolled achieved the response. Furthermore, 67% of those patients achieved a stringent complete response, and the median fallout of 12.4 miles with the data cut.

We intend to present data from quite a few of the one off of cartoon studies at major conference in 2021, and then as I mentioned that we also anticipate to publish in the paper format.

The face of our legend to long term fallout.

With that Victor can you. Please open the Q&A.

Of course.

I would remind you of ladies and gentlemen asked the question you will need to press star one on your telephone.

The only other question Chris of the town.

Please stand by.

The new roster.

The first question will come from the line of Matthew Harrison from Morgan Stanley.

Your line is open.

Great. Good morning, Thanks for taking the questions I guess two for me.

Yes, I believe you said your plan is the half.

Oh, Hey approved in the U S by the end of 2021.

Can you, maybe just comment where in the progress of the rolling submission of you guys are now in.

And the able to beat that timeline I assume you're assuming an accelerated assessment of the comment on that that would be great and then.

The second.

Maybe you could just we haven't talked about this before but maybe maybe you could just comment broadly on your expectations around the commercial opportunity in China, and what sort of work youre doing to prepare for that given youre planning.

Later this year.

Thank you Matthew for the question. So let me address your first question is about the BLA in the.

Ying Huang: The median progression-free survival has not been reached yet. This study also demonstrated a manageable safety profile for sigma cell at the recommended phase 2 dose, which is 0.75 million cells per kilogram body weight. Given that these patients were heavily pre-treated, in fact, the median life of prior therapy was six, we believe these results are really excellent.

For the United States.

So we did say that both J&J and legend expect the filter sales to be approved by FDA by end of this year.

So we're expecting to ask FDA for priority review, given our breakthrough designation by the FDA and as you know typically after a BLA package has been completed.

There is a true mass acceptance period, following which there is a six month review period for the total is eight months after we complete the BLA package.

So broadly speaking of J&J and legend the have stated that we expect out of the drug to be approved by end of 2021. Therefore.

If you do the math that means.

Should expect the BLA package it could be completed by end of April.

So we're not providing any guidance or provide any clarity on exactly when this is completed but what we can tell you today is that.

We're completely on track in terms of the BLA submission here and again, we stand by the.

Expectation that we expect to hear the cell to be approved and launched by 2021 end of this year.

So that's what we'll say about the BLA submission timeline.

Ying Huang: As we look into the rest of 2021 and also into 2022, I would like to discuss the near-term targets for the company. In the first half of 2021, we're working with our collaboration partner, Janssen Pharmaceuticals, to potentially file an MAA application with EMA for Acetacel. As I just previously mentioned, recently...

And as a reminder for yeah.

Go ahead, sorry, I would just say before you answer the second question can I just ask a quick follow up on that.

For you announce when you announce when you complete the submission or only when you have acceptance from the yes, yes.

So J&J and legend are actually discussing the disclosure around the BLA submission and the also the BLA acceptance.

Unfortunately, I am not at Liberty to tell exactly today, what our plan is.

Suffice to say that you will hear from the.

But part of it.

The partners here about this.

<unk>.

Probably the only thing I can say stock day stay.

Stay tuned, but you will hear something from J&J legend about this.

So to address the second question Matthew in terms of commercial market potential in China.

I guess, if you look at the current landscape in China. There is no commercial car T therapy yet.

Ying Huang: The EMA accepted a request from Jensen for an accelerated assessment for the marketing application for ThetaCell. We're also planning to file a PLA in China, pending discussion with CDE for filter cells in the second half of this year, in the United States, which is the most important market for filter cells. We're targeting FDA approval by end of 2021.

If you look at the CD process so far.

Two product our two product candidates, namely, yes, Carter from for Shanghai to which of the JV from zone and kite pharma.

Has it been submitted and right now it's still being reviewed by the CD the.

Of the one is the life of cell product from Wuxi, Juno, which is the JV between in Wuxi and the Juno pharmaceutical and again that is in the review process the application of being submitted to CD.

So given that there is no commercial car T therapy, yet in the Chinese market, it's difficult to comment the all for example pricing and also the.

Coverage from commercial insurance or reimbursement from the healthcare plans in in China.

Ying Huang: We're planning to initiate the Phase 1 First in Human Study for LB1901 for T-cell lymphoma in the United States. Our collaboration partner, Jensen, is also working to file an NDA with the Japan Ministry of Health, Labor, and Welfare for Siltacel in the second half of this year. In 2022, we're expecting the EMA approval for pseudocell in the European Union. We're also expecting the CD approval for pseudocell in China. In terms of the data update for our filter cell, I'm pleased to announce that Legend Biotech, in collaboration with Janssen, intends to present updated data from the CAR-T2-1 and CAR-T2-2 Phase II studies at major medical conferences in 2021.

However, if you look at the sheer number of patients.

For the suffer from myeloma or false and beyond myeloma.

<unk>.

Similar of bigger number compared to what we have in the states as you know.

In the states every year about 14000 patients Unfortunately die from multiple myeloma and thats the minimal addressable market for for us pending FDA approval and we believe the size of the patient population in China is actually larger.

However, since there is no commercial product.

Already approved in the market yet we have no benchmark.

To assess debt.

In our opinion in the first.

Launch phase.

The stock is most likely going to be paid through self pay.

That is out of pocket from patients for the.

Because right now there is a ceiling for China national coverage for the drug cost and we just don't think any car to you would come to the market immediately with the National Health plan coverage.

Okay.

Great. Thanks very much.

Thank you.

And once again as a reminder, the follow on for questions number one.

Next question will come from the line of Brian Aman from Jefferies.

You may begin.

Yeah, Hi, guys. Thanks for taking my questions.

Yeah on the <unk> two.

I believe youre going to have some data. This year can you just maybe talk about which cohorts. We should expect data in because I think there's about four of five cohorts in the trial that you guys are investigating so any color you could provide there would be helpful.

Ying Huang: In addition, Legend Biotech, along with Jensen, anticipates publishing the data from the Legend 2 Phase 1 Virgin Human Studies in 2021. As a reminder, this Phase 1 study enrolled a total of 74 patients in the Phase 1 study, and every patient has completed the required three-year fallout as of November of 2020. In the next slide, as you can see, we have a comprehensive clinical development program for filter cell inpatients with multiple myeloma.

Sure. Thanks, Peter for your question. So as you know we have already opened five cohort for the.

Current you tube programs, so far which of the global trial and.

If you look at the patient population, we're enrolling because we opened the cohort eight first.

So I just want to remind you that the cohort eight we were planning to enroll 20 of $2 30 patients who were treated with one to three prior lines of therapy and also refractory to Revlimid. So this is essentially the same patient population we're testing in the randomized <unk>.

Ying Huang: In 2020, we initiated a global phase 3 study called CAR T2-4. We also expanded the multi-cohort phase 2 study called CAR T2-2. The most recent cohort, cohort E, is enrolling patients with newly diagnosed multiple myeloma or first-line myeloma. We intend to present data from CAR-T1 and also CAR-T2 studies at major conferences in 2021.

Global Phase III trial called <unk> for <unk>.

However, this is the single arm phase II study here. So as you can imagine if we do plan to.

Published or presented any data from the constitutes two trial.

Most likely it will start with cohort.

That is the most like the patient population in which we will present data in 2021.

Great and then maybe on some of your phase one programs you've got several programs of CD 19, CD 22 60 <unk>.

Operator: And then, as I mentioned, we also anticipate publishing the faith and legend for long-term fallout. With that, Victor, can you please open the Q&A? Of course. I would remind you, ladies and gentlemen, to ask a question, you will need to press star 1 on your telephone. And to withdraw your question, press the pound. Please stand by while we compile the Q&A rollout. Our first question will come from the line of Matthew Harrison from Morgan Stanley.

CD 20, allogeneic can you just maybe talk about when we could expect data from some of the phase one studies should we expect that this year or is it more likely next year.

Absolutely happy to answer that question. So we do have six active phase one ongoing studies in China for various indications and.

Depending on which program. We're in also different stage in some programs we're screening patients in some programs for opening the sites getting through the ethical committee approvals in some.

<unk> actually already dosing patients by now.

So given the pace of the enrollment.

We're not providing any official guidance. However, I think the earliest possible time for us to report any data from the phase one program that would be the second half towards the end of this year, we should be able to have some data in hand and that is we should have a.

Matthew Harrison: Great. Good morning. Thanks for taking me.

The reasonable number of patients in terms of data.

Ying Huang: I guess two for me, Ying. I believe you said your plan is to have the CLA approved in the U.S. by the end of 2021. Can you maybe just comment on where in the progress of the rolling submissions we are now? Be able to meet that timeline, I assume you're... Accelerated Assessment.

And what these data readout coincide with the IND filing here in the U S for these programs.

Not necessarily bid for example, we're already working on.

And for the cloud the 18.2 of targeting.

Auto car T for gastric cancer and pancreatic cancer.

Right now at the same kind of we're also conducting a phase II study in China for the.

From a program in gastric cancer patients.

Ying Huang: If you could comment on that, that would be great. Second, maybe you could just, we haven't talked about this before, but maybe you could just comment broadly on that. [inaudible] Thank you, Matthew, for the questions.

We don't have much clinical data for that program, yet, but we have made the decision to move forward.

Given our belief in the scientific rationale for targeting car of the ATM point to as a treatment for gastric and pancreatic cancer.

And also.

Ying Huang: So let me address your first questions about the BLA in the United States. As you know, both J&J and Legend expect the filter cell to be approved by FDA by the end of this year. So we're expecting to ask FDA for priority review, given our breakthrough designation by the FDA. And as you know, typically, after a BLA package has been completed, there's a two month acceptance period, following which there's a six month review period.

Given the preclinical data we have the observed in all of that we have made the decision to move forward. So we are actually actively preparing for.

And the IND application in the U S for that program later this year.

Great. Thank you.

Thank you.

Thank you and actually nationally for the questions in the queue I'd like to turn the call over to Yang for any closing remarks.

Okay great.

I just want to thank everyone for dialing in and thank you very much for interest in legend biotech and digestion.

The standby if you of any further questions feel free to contact us for engineers and again. Thank you very much and we look forward to a very productive year in 2000 for anyone.

Ying Huang: So the total is eight months after we complete the BLA package. So broadly speaking, you know, J&J and Legend have stated that we expect the drug to be approved by the end of 2021. Therefore, if you do the math, that means, you know, we should expect the BLA package to be completed by the end of April.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

Okay.

Yes.

Yes.

Okay.

[music].

Yeah.

Ying Huang: So we're not providing any guidance or providing any clarity on exactly when this is completed, but what we can tell you today is that we're completely on track in terms of the BLA submission here. And again, we stand by the expectation that we expect the filter cell to be approved and launched by 2021, the end of this year. So that's what we'll say about the BLA submission timeline. And as a reminder, yeah, go ahead.

[music].

Ying Huang: Sorry, I was going to say, before you answer the second question, can I just ask a quick follow-up on that? Will you announce it? Will you announce your submission or only when you have acceptance from the FDA? So, J&J and Legend are actually discussing the disclosure around the BLA submission and also the BLA acceptance. Unfortunately, I am not at liberty to tell exactly today what our plan is, so I'd like to say that you will hear from the partners here about this. You know, probably the only thing I can say is stay tuned, but you will hear something from J&J and Legend about this.

Ying Huang: So, to address the second question, Matthew, in terms of commercial market potential in China, I guess if you look at the current landscape in China, there's no commercial CAR T therapy yet. If you look at the CD process so far, two product candidates, namely, Yescata from Fosun Kite, which is a JV between Fosun and Kite Farmer, have been submitted, and right now, it's still being reviewed The other one is the Lifesell product from Wuxi Juno, which is a JV between Wuxi and Juno Pharmaceutical, and again, that is in the review process.

Ying Huang: The application has been submitted to CDE. So, given that there's no commercial CAR T therapy yet in the Chinese market, it's difficult to get coverage from commercial insurance or reimbursement from healthcare plans in China. However, if you look at the sheer number of patients who suffer from myeloma or false-positive line and beyond myeloma, it's actually a similar or bigger number compared to what we have in the States. As you know, in the States, every year, about 14,000 patients unfortunately die from multiple myeloma, and that's the minimal addressable market for us pending FDA approval, and we believe the size of the patient population in China is actually larger.

Ying Huang: However, since there's no commercial product that's already approved in the market yet, we have no benchmark to assess that. In our opinion, in the first launch phase, this drug is most likely going to be paid through a self-pay mechanism that is out-of-pocket from patients. This is because right now there's a ceiling for China's national coverage for the drug cost, and we just don't think any CAR T would come to the market immediately with the National Health Bank coverage.

[music].

Ying Huang: Great, thanks very much. Thank you. And once again, as a reminder, that's star number one for questions, star number one. Our next question will come from the line of Byron Ahmed from Jefferies.

Byron Ahmed: Yeah, hi guys. Thanks for taking my questions. Ying, on CARTITUDE 2, I believe you're going to have some data this year. Can you just maybe talk about which cohorts we should expect data from? Because I think there are about four or five cohorts in the trial that you guys are investigating. So any color you could provide there would be helpful.

Ying Huang: Sure. Thanks, Biren, for your question. So, as you know, we have already opened five cohorts for the CAR-T2-2 program, which is a global trial. And...

Ying Huang: If you look at the patient population we're enrolling, because we opened Cohort A first, so I just want to remind you that in Cohort A, we were planning to enroll 20 to 30 patients who were treated with one to three prior lines of therapy and also reflux rate to rev limit. So this is essentially the same patient population we're testing in the randomized global phase 3 trial called QALYTUDE4. However, this is a single-arm phase 2 study here.

Ying Huang: So, as you can imagine, if we do plan to publish or present any data from the QALYTUDE2 trial, it will probably start with Cohort A. That is the most likely patient population in which we will present data in 2021.

Ying Huang: Great, and then maybe on some of your Phase I programs. You've got several programs, CD19, CD22, CD3 CLL, and CD20 Allogeneic. Can you just maybe talk about when we could expect data from some of the Phase I studies? Should we expect it this year, or is it more likely next year?

Ying Huang: Absolutely, happy to answer that question. So, we do have six active Phase I ongoing studies in China for various indications, and depending on which program, we're also in different stages. In some programs, we're screening patients. In some programs, we're opening sites, and getting through the ethical committee approvals. In some programs, we're actually already building patients by now. So, given the pace of enrollment, we're not providing any official guidance. However, I think the earliest possible time for us to report any data from these Phase I programs would be the second half, towards the end of this year. We should be able to have some data in hand, and that is, we should have a reasonable number of patients in terms of data.

[music].

Ying Huang: And would these data readouts coincide with the IND filing here in the U.S. for these programs? I'm not necessarily sure...

Ying Huang: Not necessarily, Biren. For example, we're already working on an IND for clouding 18.2, targeting autoclarity for gastric cancer and pancreatic cancer. Right now, at the same time, we're also conducting a phase one IIT study in China for this same program in gastric cancer patients. We don't have much clinical data for that program yet, but we have made a decision to move forward. Given our belief in the scientific rationale for targeting clouding 18.2 as a treatment for gastric and pancreatic cancer and also given the preclinical data we have observed in our lab, we have made a decision to move forward.

Ying Huang: So we're actually actively preparing for an IND application in the U.S. for that program later this year. Great. Thank you. Thank you. Thank you. And we're actually not showing any further questions in the queue. I'd like to turn the call over to Ying for any closing remarks. Okay, great.

Ying Huang: Again, I just want to thank everyone for dialing in, and thank you very much for your interest in Legend Biotech. Jessie and I will be on standby.

Ying Huang: If you have any further questions, feel free to contact us through any means. And again, thank you very much. And we look forward to a very productive year in 2021. Ladies and gentlemen, this concludes today's conference call. Thank you for participating.

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