Legend Biotech - Earnings Call - Q4 2020

Transcript

Speaker 0

Ladies and gentlemen, thank you for standing by, and welcome to the Legend Biotech Reports Fourth Quarter twenty twenty Financial Results. At this time, all participant lines are in a listen only mode. After the speaker presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference to your speaker today, Jessie Young.

Please go ahead, ma'am.

Speaker 1

Good morning, everyone. I hope everyone is safe and healthy. Welcome to Legend Biotech's fourth quarter and full year twenty twenty earnings conference call. This is Jessie Young, Head of Corporate Finance and Investor Relations for Legend Biotech. Joining me on today's call is Jing Huang, Chief Executive Officer and Chief Financial Officer for Legend Biotech.

A few logistics before we get into the details. This review is being made available via webcast accessible through the Investor Relations section of the Legend Biotech website. Please note that today's presentation includes forward looking statements. We encourage you to review the cautionary statement regarding such statements in today's presentation as well as the company's prospectus filed with the SEC on June 8, which identifies certain factors that may cause the company's actual results to differ materially from those projected. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, Actual results may vary materially from those described in this presentation.

Lightning Biotech specifically disclaims any obligation to update any forward looking statements. 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 twenty '20 data before we end today's call with a Q and A session. I would now like to turn the conference call to Ying.

Speaker 2

Thank you, Jessie, and good morning, everyone. Welcome to our fourth quarter and twenty twenty 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 what we do here and why we do what we do here at Legend. It is to serve the patients.

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. Within the 2020, we achieved critical milestones. At the recent ASH twenty twenty conference, our collaboration partner JNJ and Legend shared exciting results from combined Phase 1b and Phase two CARLITUDE-one study of sutra cell and the investigation of BCMA targeted CAR T therapy. The data continued to show a very high overall response rate, specifically ninety seven percent of patients achieved a response.

More importantly, sixty seven percent of the patients achieved a stringent complete response at a median follow-up of twelve point four months. Also in December 2020, we initiated rolling submission of BLA or Biologics license application to the US FDA for Silto Cell. This submission is based on results from the pivotal Phase 1bPhase two CARTITUDE one study that evaluated the efficacy and safety of Silto Cell in the treatment of patients with relapsed and or refractory mycomyeloma. We also announced the US FDA cleared the IND application for LB1901 which is Legend Biotech Investigational Autologous CAR T targeting CE4 for 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 options, there remains a high unmet medical need for these patients.

With this IND clearance, we're planning to initiate a Phase one first in human study for LB1901 in The United States. Lastly, we also achieved the designation of accelerated assessment in Europe for the treatment of relapsed and refractory myeloma for Futa cell. The CHMP or Committee for Medicinal Products for Human Use in European Medicine Agency accepted the request from Janssen, our collaboration partner for this assessment, which means instead of the two ten evaluation days for the evaluation process by EMA, this accelerated assessment usually takes one hundred and fifty evaluation days. Now let's turn over to the financial results from 2020 and also fourth quarter twenty twenty. Our net loss under IFRS accounting standards in 2020 was about $3.00 $3,000,000 This compared to a loss of $133,000,000 in 2019.

Loss per share for 2020 was $1.28 compared to $0.66 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 CAR TUTO program as well as CARDIFANG program in China. In terms of quarter over quarter comparison, in the 2020, our net loss was about $58,000,000 and that compared to $64,000,000 loss in the 2019. Loss per share for the 2020 was $0.22 compared to $0.32 loss per share in the 2019. In the next slide, 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 CARDITUDE one in The U. S, the CARDITUDE two five cohort Phase two trial globally and also the ongoing Phase three randomized active controlled CAR T2 four Phase three trials. In China, we're conducting the pivotal Phase two trial called CARDIFY-one. Besides the BCMA program, we're continuing to conduct the Phase one first in human studies, IIT studies in China. This includes a duratogin CD19, CD22 auto CAR T for non Hodgkin's lymphoma, a dual targeting CD33 CLR1 auto CAR T for acute leukemia and also a CD4 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 CD20 targeting allogeneic CAR T for non Hodgkin's lymphoma. The second one is a gamma delta BCMA targeting T cell program for the treatment of myeloma. In solid tumor fields, we're conducting a study for Cloudin eighteen point two targeting auto CAR T for gastric cancer and pancreatic cancer. In addition, we recently started a Phase one study for a mesothelin targeting auto CAR T for ovarian cancer.

Now I'd like to take a moment to highlight some of the clinical data from the CAR TUDE-one study that was presented recently at the ASH twenty twenty conference. As you can see from this slide, the data continues to show a very high overall response rate, specifically ninety four out of the ninety seven patients enrolled achieved the response. More importantly, sixty seven percent of those patients achieved a stringent complete response. At the median follow-up of twelve point four months with a data cut, the median progression free survival has not been reached yet. This study also demonstrated a manageable safety profile for silted cell at the recommended Phase two dose which is zero point seven five million cells per kilogram body weight.

Given that these patients were heavily pretreated, in fact median life of prior therapy was six. We believe these results are really excellent. As we look into the rest of twenty twenty one and also into 2022, I would like to discuss the near term targets of the company. In the 2021, we're working with our collaboration partner Janssen Pharmaceuticals to potentially file the MAA application with EMA for psuta cel. As I just previously mentioned, recently the EMA accepted a request from Janssen on accelerated assessment for the marketing application for psuta cel.

We're also planning to file BLA in China pending discussion with CDE for Siltacell in the second half of this year. In The United States, which is the most important market for Siltacell, We're targeting FDA approval by 2021. Lastly, we're planning to initiate the Phase one first in human study for LV-nineteen oh one for the T cell lymphoma in The United States. Our collaboration partner Janssen is also working to file an NDA to the Japan Ministry of Health, Labor and Welfare for FutaCell in the second half of this year. In 2022, we're expecting the EMA approval for FutaCell in European Union.

We're also expecting the CD approval for FutaCell in China. In terms of the data update for our TUTOCELL, I'm pleased to announce that Legend BioTek in collaboration with Janssen intends to present update data from the CAR TUDE-one and CAR TUDE-two Phase two studies at major medical conferences in 2021. In addition, Legend Biotech along with Janssen anticipates to publish the data from the Legend two Phase one first in human studies in 2021. As a reminder, this Phase one study enrolled a total of 74 patients in the Phase one study and every patient has completed the required three year follow-up as of November 2020. In the next slide, as you can see we have a comprehensive clinical development program for TutaCell in patients with multiple myeloma.

In 2020, we initiated a global Phase three study called CAR TU-four. We also expanded the multi cohort Phase two study called CAR TU-two. 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 conference in 2021. And then as I mentioned, we also anticipate to publish in a paper format the Phase one Legend two long term follow-up.

With that Victor can you please open the Q and A?

Speaker 0

Of course. Our first question will come from the line of Matthew Harrison from Morgan Stanley. Your line is open.

Speaker 3

Great. Good morning. Thanks for taking the questions. Guess two for me. Ying, I believe you said your plan is to have the BLA approved in The U.

S. By the 2021. Can you maybe just comment where in the progress of the rolling submission you guys are now? And to be able to beat that timeline, I assume you're assuming an accelerated assessment. So if you could comment on that, that would be great.

And then second, maybe you could just we haven't talked about this before, but maybe you could just comment broadly on your expectations around the commercial opportunity in China and what sort of work you're doing to prepare for that given you're planning to submit sometime later this year? Thanks.

Speaker 2

Thank you, Matthew for the question. So let me address your first question about the BLA in The United States. So we did say that both J and J and Legend expect the sertral cell 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's a two month acceptance period following which there's a six month review period.

So the total is eight months after we complete the BLA package. So broadly speaking, JNJ and Legend have stated that we expect the drug to be approved by 2021. Therefore, if you do the math, that means we should expect the BLA package to be completed by 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 sericel to be approved and launched by 2021 end of this year. So that's what we'll say about the BLA submission timeline. As a reminder yes, go ahead.

Speaker 3

Sorry, I was going say before you answer the second question, can I just ask a quick follow-up on that? Will you announce when you complete the submission or only when you have acceptance from the FDA?

Speaker 2

So J and 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. Suffice to say that you will hear from the partners here about this. Probably the only thing I can say is stay tuned, But you will hear something from the Indian legend about this. So to address your 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 or two product candidates namely Yescarta from Forson Kite which is JV from Forson and Kite Pharma has been submitted. And right now it's still being reviewed by CDE. The other one is the lysocell product from Wuxi Juno, which is a JV between Wuxi and Juno Pharmaceutical. And again, that is in the review process. 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 comment on for example pricing and also the coverage from commercial insurance or reimbursement from the healthcare plans in China. However, if you look at the sheer number of patients who suffer from myeloma or fourth 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 fourteen thousand 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. However, since there's no commercial product that's been 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 self pay mechanism that is out of pocket from patients for this because right now there's a ceiling for China 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 plan coverage.

Speaker 3

Great. Thanks very much.

Speaker 2

Thank you.

Speaker 0

Our next question will come from the line of Daiwan Ahmed from Jefferies. You may begin.

Speaker 4

Hi, guys. Thanks for taking my questions. Ying, on CARTITUDE II, I believe you're 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 or five cohorts in the trial that you guys are investigating.

So any color you could provide there would be helpful.

Speaker 2

Sure. Thanks, Biren, for your question. So as you know, we have already opened five cohorts for the CAR T2 program so far which is a global trial. And if you look at the patient population we're enrolling because we opened the cohort A first. So I just want to remind you that in the cohort A, we were planning to enroll 20 to 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 global Phase three trial called CAR TUDE-four. However, this is a single arm Phase two study here. So as you can imagine, if we do plan to publish or present any data from the COLIDIUSE two trial, most likely it will start with cohort A. That is the most likely patient population in which we will present data in 2021.

Speaker 4

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

Speaker 2

Absolutely, happy to answer that question. So, Bill, 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 we're opening sites getting through the ethical committee approvals. In some programs we're 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 these Phase one programs would be 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, you know, reasonable number of patients in terms of data.

Speaker 4

And would these data readout coincide with the IND filing here in The U. S. For these programs?

Speaker 2

Not necessarily, Bill. For example, we're already working on IND for the Cloudin 18.2 targeting auto CAR T 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. Although 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 CARD18.2 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.

So we're actually actively preparing for IND application in The U. S. For that program later this year.

Speaker 4

Great. Thank you.

Speaker 2

Thank you.

Speaker 0

Thank you. And I'm actually not showing any further questions in the queue. I'd like to turn the call over to Ying for any closing remarks.

Speaker 2

Okay, great. Again, I just want to thank everyone for dialing in and thank you very much for interest in Legend Biotech and Jesse and I will be standby. 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.

Speaker 0

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