Greetings. Welcome to the Immunocore 2022 Financial Results and Business Update Call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to your host, Clayton Robertson, Head of Investor Relations. Thank you. You may begin.

Thank you, Daryl. Welcome to our Q4 and 2022 financial results call. Before we begin, I would like to remind you that this call will contain forward-looking statements within the meaning of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. These include expectations and plans concerning future events, prospects and performance, including with respect to commercialization, clinical development and trials, regulatory approvals and financial results. Actual events may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those disclosed in our filings with the SEC. And such statements represent our views only as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. I'm now pleased to introduce Immunocore's CEO, Dr. Bahija Jallal.

Thank you, Clay. Good morning and good afternoon, everyone. We're very happy to share an overview of our 2022 performance. With me today are Ralph Torbay, our Head of Commercial; Brian Di Donato, our Chief Financial Officer and Head of Strategy; and David Berman, our Head of Research and Development. We will be happy to take questions at the end. 2022 was a momentous year, one that established Immunocore as the leader in TCR therapeutics. It is not every day that the company can achieve the first, which makes it even more meaningful to have delivered 3 first with the launch of KIMMTRAK. And we will not stop there. We will stay true to our mission to radically improve outcomes for patients with cancer, infectious disease and autoimmune conditions, and we're never satisfied with incremental benefit. And I'm extremely proud of how our teams had advanced this mission in 2022. So let's take a look at the highlights from 2022. KIMMTRAK is the first and only approved treatment for unresectable or metastatic uveal melanoma. It is now approved in more than 30 countries, and we have treated more than 500 patients since the end of Phase 3 trial with KIMMTRAK. We have revenues of just over $140 million with 25% quarter-over-quarter growth. For a biotech of our size, what the team has achieved is amazing. Ralph will provide you with more details about our launch performance as well as our plans to launch in more countries and make KIMMTRAK available to even more patients. Our research and development teams having successfully passed the [indiscernible] KIMMTRAK to the commercial and medical teams have delivered substantial progress with our pipeline. Starting with tebentafusp, we are screening patients with advanced melanoma in Phase 2/3 trial. We presented initial data with our ImmTAC therapy…

Thank you, Bahija. I'm delighted to be here today to provide you with an update on what was a very successful launch year. Approvals in over 30 countries and the launch of KIMMTRAK, we have strongly delivered against the promise of radically improving outcomes for patients living with metastatic uveal melanoma. This has been recognized with KIMMTRAK inclusion into the ASCO and NCCN guidelines, recommending it as a standard of care for patients with mUM and through the prestigious innovative therapy award from [indiscernible] in France and the best new drug award from script. Our teams have executed flawlessly launching KIMMTRAK just days after approval, achieving reimbursement in the U.S., Germany and France, transitioning all EAP patients to commercial supply within weeks and importantly, establishing KIMMTRAK as the most prescribed medicine for HLA-A02:01 positive metastatic tubulomynoloma patients across all countries that we've launched in. In 2022, we recognized $141 million in net sales of KIMMTRAK, primarily in 3 major countries. Our Q4 net sales of $51 million represents approximately a 25% quarter-over-quarter growth. This was driven by strong demand in the U.S., including a onetime increase in year-end stocking at our specialty distributors and single-digit demand growth in Germany and France. Let's now look at our progress in the U.S. and what to expect moving forward. The outstanding execution by our U.S. team delivered KIMMTRAK to 240 new accounts in 2022. We believe these capture approximately 50% of the patient potential, and we plan to continue increasing the number of new accounts, especially in the community. Our focus on enabling first-line patients, we closed the year with 60% of KIMMTRAK share in first line, being treated closer to home is important for patients and the future of our therapy. At the end of 2022, 1 out of 2 patients were…

Thank you, Ralph. Today, we will focus on the financial highlights in the fourth quarter and year-end 2022 and provide some insights into 2023. Please refer to the press release we issued this morning and our SEC filing on Form 20-F later today for our full financial results. Comparisons discussed versus third quarter 2022 using U.S. dollar convenience rates unless otherwise stated. On Slide 14, you see a summary of our financial results. I'm excited to report that our teams continue to execute and to deliver KIMMTRAK to patients in the United States, Germany and France, with the impressive site expansion and seamless reimbursement while continuing to expand our global early access program in new countries currently treating nearly 200 patients. In Q4, we increased vial sales in both the U.S. and Europe. Total fourth quarter net revenue, as Ralph mentioned, was $51.1 million when converted to U.S. dollars, an increase of 25% over Q3. In the U.S., we saw a 50% increase in Q4 net sales, in part due to some onetime year-end stocking and the year-end adjustment of gross to net, which produced 340B and Medicaid assumptions. In Europe, even with an increase in vial sales, net revenues decreased to $12.2 million due to new reimbursement accruals for Germany, which started on November 1 and will continue until final pricing agreement expected in Q2. On the expense side, SG&A increased to $52.1 million in Q4, partly due to a currency loss of $50 million on U.S. dollar reserves when it's translated back to great British pounds. R&D expenses for the quarter increased to $32.8 million and are expected to marginally increase throughout 2023 as we expand and accelerate our clinical development portfolio. The company has capitalized with over $400 million in cash and cash equivalents at year-end. With…

Thank you very much, Brian. We are very proud to have brought KIMMTRAK as the first approved medicine for metastatic uveal melanoma. Gp100 which is the target of KIMMTRAK, is also expressed in other melanoma types, including cutaneous melanoma. All of the efficacy signals we observed in early trials for tebn in mUM are also replicated in cutaneous melanoma, and this gives us confidence to initiate a registrational program in previously treated cutaneous melanoma with a survival endpoint. The study is now screening patients, and we estimate the opportunity in this indication is 2x to 4x the size of uveal melanoma. Gp100 is a melanoma specific target. And with PRAME, we have the opportunity to go to other solid tumors. And based on the strength of the Phase 1 data, we have invested in building a franchise around this target. The lead program, F106C targets a PRAME peptide presented by HLA-A02. At ESMO last year, we showed that F106C induced durable PRs in uveal melanoma, cutaneous melanoma and ovarian carcinoma. And our focus now is to expand the trial footprint globally and enrolled 4 monotherapy expansions as well as combinations. We expect to have efficacy data by the first half of '24. In January, we announced that we will be bringing 2 new PRAME impacts to IND in the next 18 months. T119C targets a PRAME peptide presented by HLA-A24 and this will expand the potential addressable population by 30%. In Japan alone, for example, 60% of patients are positive for A24. P115C targets the same HLA-A02 peptide as the lead program that has an extended half-life. We know that our current platform with a standard half-life is very active with durable PRs in multiple solid tumors and for tebentafusp a dramatic survival benefit. Nevertheless, given our enthusiasm for PRAME,…

Thank you, David, Brian, and thank you, Ralph. As you have heard, 2022 was an amazing and transformative year for the company. We have definitely written the next chapter in oncology treatment as we pioneered and now launched KIMMTRAK. This pipeline reflects the large potential that our ImmTAC platform can offer to patients across many cancer types, and as you just heard, also infectious diseases. Given the breadth and depth of our pipeline, we need to continually prioritize our portfolio candidates. You'll note that we have removed our ImmTAC candidate targeting MAGE-A4(AO2). We have opted out of our co-funding agreement with Genentech, given our focus on PRAME. In the collaboration, we are eligible to receive development of commercial milestones if Genentech advances the MAGE-A4(A02) therapy. This is a robust pipeline based on which we will continue building Immunocore as the growing leader in TCR therapeutics. So officially, Immunocore is now a commercial stage biotech company. I'm very proud to report such revenues for Q4 and 2022 and a cash runway into 2026 that will allow us to continue delivering against our commitment as we have done to date. Our performance is even more significant in the context of what has been another challenging year for the biotech sector. So as we wrap up our remarks, I'm excited for the year ahead. So if 2022 was a transformative year, 2023 will be a year expanding on those successes. Our priorities are clear. We are focused on launching and growing KIMMTRAK and enrolling the cutaneous melanoma trial. For our PRIME program, we are investing in increasing the site footprint and enrolling patients in multiple tumor types as well as in combination with standards of care. We are also expanding the PRAME franchise with an eye towards multiple INDs in the next 18 months. Also in oncology, we plan to file an IND for our first-in-class therapy targeting PIWIL1 later this year. And infectious disease, we have finished a single ascending dose portion of the HIV trial and started the multiple ascending dose part to identify safety and also antiviral activity that could lead to a functional cure. Along the way, we will continue to focus on cost and cash discipline the way we have been every step of the way. So as we enter 2023, we do so with same drive, determination and sense of urgency to radically improve outcomes for patients. With that I want to thank every single employee at Immunocore. I want to thank you as our investors and shareholders for your support. But most importantly, I want to thank our patients and our -- and their families. And now, I'll be happy with the team to take your questions, and we'll open the call for questions. Thank you.

[Operator Instructions] Our first question comes from the line of Michael Yee with Jefferies.

Congrats on a great year. Two questions. On the KIMMTRAK sales in U.S., there was a very strong number there. And then you mentioned that there were some onetime positive impacts like gross to net and also some inventory. Could you just help us understand what the underlying number of demand there was in the fourth quarter, so that could help us get a good run rate going into 2023? And describe what you think the growth rate looks like throughout 2023 for the U.S.? And then a question on PRAME, maybe for David. I know you're enrolling the Phase 2 or Phase 1 the expansion cohorts. Can you talk to us a little bit about how you think about the bar for lung cancer and the expectation for lung cancer, given what you've seen previously and to help right size us or what is good lung cancer data?

Thank you, Michael. Great questions. Brian, you’ll take the first one and then David.

Yes. So Michael, some more specifics around those 2 increases in Q4. Together, they're about $5 million that we saw for increase in stocking and a reduction in gross to net, mostly 340 the assumptions that we use. We're probably a little bit conservative, so about $5 million. So the U.S. instead of being $38 million it was probably around $33 million in real end demand. So that's probably a pretty good number as we move into Q1 for benchmarking. And as we mentioned, as we have saturated or have now penetrated most of the academic centers, and we're moving in community growth, you should expect growth to be slower in 2023 in the U.S. The other dynamic is we'll have another month of German discount for Q1 versus Q4. So that will reduce it a little bit more as well from a benchmark perspective.

Yes, Michael, I guess I would answer it in 2 ways. The first is that lung is a very complex tumor. So we need to study different populations. For example, the EGFR ALK mutation is historically IO insensitive. And of course, we're studying patients now who've also failed on checkpoints. So there's that lung complexity we need to take into account. But in terms of expectations of what we’re looking for, I think I would look at it 2 ways. One is we’re looking to get confidence that F106C is active in line. Is there any evidence of activity, i.e., ctDNA reductions? And then we’re looking for confidence in RECIST endpoint. Is there the opportunity for response rate or PFS. And so I think those are the 2 levels of activity that we're looking at.

Our next questions come from the line of Jessica Fye with JPMorgan.

This is Nick [ph] on for Jess. Today, you mentioned that you're about 50%, 60% patients on therapy in the first-line study. How does that -- did that hold true across the U.S. or Europe? Or is one region more heavily weighted towards first line or second line versus the other?

Great. Ralph, you can take that one.

Nick, thank you for the question. So look, in the U.S., we are seeing 60% of the KIMMTRAK patients in first line. So the remainder of them are in second line plus. In Europe, specifically in Germany and France, we’re seeing around 45%, and that’s where we’re focused on increasing because our focus is first line. That’s where we see OS that’s where we see the duration of therapy. We’re focused on increasing that as high as we can get it.

Our next questions come from the line of Tyler Van Buren with Cowen.

This is Tara [ph] on for Tyler. So when you say that the PRAME dose expansion data are expected by the first half of 2024, is there a chance that it could come later in 2023, maybe at ESMO or one of those conferences? And are there any other data updates this year that we can look forward to?

Yes. It’s really the -- our strategy was to invest early into expanding the footprint for the clinical footprint. I think that in any drug development, that’s what takes the longest. And that’s exactly what we want to focus the team on and that it’s a pretty comprehensive program with multiple arms for the monotherapy plus the combination. So that’s really the focus, and that’s why we are going globally and we said we’ll bring the data by the first half of 2024.

Our next question comes from the line of Patrick Trucchio with H.C. Wainwright.

I actually have a follow-up question on the capital allocation focus. Specifically with KIMMTRAK revenues ramping, while multiple programs continue through development and these new programs emerge. I’m wondering if you can discuss the focus for capital allocation in the next year and beyond, particularly as it relates to balancing the focus on R&D and pipeline development with the potential eventual pivot to profitability. How do you balance these priorities? And when might the company achieve profitability?

Yes. Thank you. Thank you for the question. I'll start and then Brian. Really, our focus is expanding the pipeline. As you have seen, the pipeline is expanding, and that's exactly what we will be -- the dollars will go there. I think it's very important. We have some great assets. But Brian, do you want to comment on that as well?

Yes. Great question, Patrick. If you look at our research expenses over the last 3 years, we’ve been pretty consistent in our research expenses, and we’ve been able to deliver these new ImmTAC molecules like well PIWIL, PRAME-A24, PRAME half-life extension with those research expenses. So we don’t expect that to change dramatically. Well, what will change and will scale as you would expect, would be the development cost as we move and advanced PRAME. And it’ll really be driven in the large part by how many large pivotal trials we need to run for PRAME. So that’s where we’re focused. We have those in the budget now. You’ll notice that we did opt out of the co-development co-funding of MAGE as we focus on the PRAME expansion. And however, we still appreciate the collaboration with Genentech, and we’ll still be in collaboration with them and be able to receive milestones and royalties from MAGE-A4 if they move that forward.

Our next question comes from the line of Justin Kim with Oppenheimer.

With regards to the median [indiscernible] duration, does the team have any intake on how physicians are managing patients through situations of potential to the progression? And are there any tools to observationally compare how the experience might be additive to the clinical trial experience, perhaps benchmarking against HLA-A02 negative patient?

Great, Justin. I think Ralph you can talk about the DOT and where we are compared with clinical trials, go ahead.

Justin, look, it's really great when we launched a new medicine, and we see the experience in the clinical trial being replicated in the real world because that means that the safety and efficacy that we've seen in the clinical trial is true and physicians are able to really use the medicine the way that is intended. And the patients are seeing the benefit and physicians are seeing that the patients benefit. So from a medium perspective, we’re at 6 months. And from a mean, we’re tracking to 9 months. And if you recall, that’s what we saw exactly in the clinical trial. As that relates subset progression, we keep educating on that aspect or treatment beyond progression, we keep educating on that aspect. Of course, today, we see treatment patterns to -- very similar to what we’re seeing in academic accounts, which is why we’re also seeing this mean duration of treatment at tracking to 9 months.

Our next question comes from the line of Justin Zelin with BTIG.

Maybe just a follow-up on the prior question just on duration of therapy. Do you expect that this duration of therapy, what kind of tick in the results seen thus far mirroring the clinical trials in the real world? Or do you think that it’s possible that you could see extension with more follow-up here?

Go ahead.

So Justin, that’s what we expect. We expect to see so far what we’ve seen in the clinical trial. And if you look at our clinical trial to a clinical trial, you see the median staying somewhat the same and then the mean growing not significantly, and that’s driven mostly by the tale. So we do expect that the longer we’re in the market, if physicians keep treating the way they’re treating, we do expect the mean to be growing, not significantly, and I think you can use the clinical trial the benchmark to see where this is going.

Our next question comes from the line of Peter Lawson with Barclays.

I guess more of a follow-up here, just around where you think that duration of treatment could eventually settle for KIMMTRAK? And the half-life extension, is that for patient convenience? Or do you think that could help with durability as well?

Yes. Great. I think Ralph you take the duration and maybe David on the half-life expected -- extension.

So, I think the best answer I can give you is that we're going to be providing an update of our 3-year overall survival, which will include duration of therapy in PFS at an upcoming conference. So I invite you to take a look at that. So you can see where we expect the mean duration of treatment to go. David?

Yes. Peter, you know what’s remarkable with KIMMTRAK with a plasma half-life of 8 hours, we saw survival benefit with a hazard ratio of 0.51. So we know that our current platform is, of course, very highly active. I think it’s an open question about whether a half-life extension will have any improvement in efficacy or durability. We’ll have to just be data driven on that.

Our next question comes from the line of Jeff Hung with Morgan Stanley.

For advanced melanoma, can you talk about why you’re using ctDNA in Phase 2? And how predictive do you think that is for survival endpoint in Phase 3? And then for PRAME, how do you think about treating multiple HLAs? And what needs to be done to get there?

Right. Great question. David?

So for the advanced melanoma, the dual endpoints for the Phase II are both ctDNA and overall survival. The reason we’re doing ctDNA is because that gives us the earliest fastest read so that we can make the decisions for the Phase 3, i.e., drop one of the arms, repower it. We also designed it though, because ctDNA is not yet completely validated in cutaneous melanoma, we realize that. It’s going to give us a directional look. We designed it also to have a survival look. We realized survival won’t be mature at that point, but we will have enough power to get an estimate about whether survival is trending. So that’s really the reason for the ctDNA. With regard to the second question, I think you’re asking about different alleles for PRAME. Is that Correct?

Yes.

So after A2, the most attractive HLA allele for PRAME A24, and that’s why we announced that we are pursuing this HLA-A24. And we’ll take the learnings from the HLA-A2 allele and apply it to A24 to make it develop faster. We estimate this will increase the opportunity 30% from a patient population opportunity.

Our next question comes from the line of Nick Gallo with Goldman Sachs. [Technical Difficulty] Looks like we lost Nick. I'm going to bring through the next questioner. Our next questions come from the line of Ahu Demir with Ladenburg Thalmann.

Congrats on a good quarter and a year. My first question is on KIMMTRAK. Could you maybe provide more color on discontinuation rates and treatment beyond progression in the real world?

Great. Thank you. Ralph, do you want to...

Great question. So we are seeing the treatment discontinuations to be in line with what we expected in the clinical trial experience. In fact, we look at closely the reasons for discontinuation and they're really tracking very well. We're not seeing any surprises, which is always great to see when you go into the real world. With regard to treatment beyond progression, what we do is we ask physicians, whether they are comfortable treating beyond progression. And then obviously, that’s part of our conversations that we have from a medical affairs perspective with physicians. And so far, we are seeing that level of comfort. Of course, as we go into the community, more education needs to be had, and that’s what we're focused on.

Yes. I think it's a really good point because in the academic centers, there -- the investigators are the ones who actually saw that there is benefit beyond progression. So I think there is more work to be done when we go into the community, but that's where the MSLs and the education and the science will come in.

There are no further questions at this time. I would now like to hand the call back over to Bahija Jallal for any closing remarks.

Yes. So, thank you so much for your questions, and thank you for your support, and we’re going to now close the call. Thank you.

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.