Immunocore Holdings plc (NASDAQ:IMCR) Q4 2022 Earnings Call Transcript

Immunocore Holdings plc (NASDAQ:IMCR) Q4 2022 Earnings Call Transcript March 1, 2023

Operator: Greetings. Welcome to the Immunocore 2022 Financial Results and Business Update Call. 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.

Clayton Robertson: 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.

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 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 targeting PRAME-A02 at ESMO, showing 3 things: RECIST responses, reduction in circulating tumor DNA across multiple solid tumors and most importantly, durability of response. Our focus now is increasing the trial footprint for the PRAME-A02 Phase 1/2 trial across multiple tumor types as well as in combination with standards of care. In addition, we have announced 3 new candidates in our pipeline. The first to expand our PRAME franchise with ImmTac therapies targeting PRAME-A24 and PRAME-A02 half-life extended. The third one is an exciting one, is a first-in-class novel immunotherapy targeting PIWIL.

PIWIL has the potential for patients with colorectal cancer and other GI tumors, which are so far insensitive to checkpoint inhibitors. Confirming further the potential of our ImmTac platform, we presented the first safety and pharmacodynamic activity with our ImmTac in HIV just last week at CROI. With this HIV candidate and our HBV therapy, we presented data last year, our aim is to evaluate their potential as a functional cure. As you can see, we had a very busy and productive 2022. We are well placed to deliver these ambitious goals with our projected financial runway taking us into 2026. I will now hand it over to Ralph.

Ralph Torbay: 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 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 being treated in the community. I’m pleased to see the efficacy and tolerability of KIMMTRAK reported in our Phase 3 clinical trial playing out in the real-world setting. While it remains early to confirm the average duration of therapy, our commercial persistence models indicate that KIMMTRAK duration of therapy is tracking to a mean of around 9 months, which is broadly in line with our expectations. From an access perspective, our teams have done a tremendous job in securing formal policy coverage for over 90% of all potential patients in the U.S. And last year, we saw 99% of prescription covered. We continue to work hard towards our goal of supporting access for every single patient who needs KIMMTRAK to our KIMMTRAK Connect program.

Let’s move on to Europe, where we’ve had a fantastic launch as well. With over 100 accounts treating patients with KIMMTRAK across Germany and France, we are capturing nearly all potential patients with mUM in these key markets. The European team are dedicating their efforts to increasing patients treated with KIMMTRAK in first line by working to expand our treatment footprint into office-based physicians in Germany and with dermato-oncologist in France. The clinical value of KIMMTRAK has been recognized in Germany by the GBA with a considerable added benefit rating. This is particularly important as KIMMTRAK becomes 1 of only 3 oncology products in the last 10 years to have received a strong rating, which will support our ongoing price negotiations.

We expect to reach a negotiated price by the first half of the year. This negotiated price will apply retroactively and we have started accruing for this potential discount in our German net sales as of November 2022. In France, we have received an ASMR rating of 3 and then SMR benefit of importance. With no restrictions and not relevant clinical comparators, this strong rating will enable us to begin pricing negotiations in the second half of 2023, with an agreement expected in the first half of 2024. 2022 was certainly a historic year for patients with mUM and for Immunocore. One year ago, we began delivering the amazing innovation that is KIMMTRAK to patients. Today, we have successfully launched in 3 countries, radically improved outcomes for more than 300 patients, and our early access program has benefited over 500 patients globally.

Looking ahead, we expect to launch KIMMTRAK in one major European country around midyear and in up to 5 additional countries by year-end. Across countries where reimbursement is not yet available, we continue to offer KIMMTRAK to nearly 200 patients through the EAP. We remain focused on our ambition of making KIMMTRAK available to over 1,000 patients by 2025. With that, I want to thank the team for an excellent 2022. Thank you for your support. And now I invite Brian to take you through our financial results.

Brian Di Donato: 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 projected KIMMTRAK revenue, this provides a runway into 2026 with the current development plans, including our new ImmTACs portfolio candidates. Ralph has shared with you some of the key drivers for KIMMTRAK looking ahead. On Slide 15, it summarizes some of these insights as we head into 2023. In Europe, a key dynamic will be formal reimbursement agreement in Germany and France as well as the expected launch of commercial KIMMTRAK in one additional major European country by midyear, and we expected 5 additional new countries by year-end.

In the U.S., one opportunity for growth is new community oncology accounts, which tend to be lower density than academic centers, which may lead to lower U.S. growth rates as we move into 2023. Globally, it’s too still too early to know real-world ration of treatment. However, currently, we are approaching the 9 months observed in the clinical trials. Another consideration in the U.S. is the 2021 Refund Act. TAP requires drug manufacturers to rebate CMS for discarded drug events. Starting in Q4 2023, CMS may request a rebate of a portion of our CMS sales for KIMMTRAK. We plan to seek an exemption from CMS as we follow FDA and USP guidance regarding required fill to ensure patients safely and consistently receive 68 micrograms of KIMMTRAK. Given the number of moving revenue targets in 2023, it is still too early to accurately provide sales guidance for the year.

The team and I are extremely pleased with the commercial team’s execution and bringing KIMMTRAK to patients globally, and we look forward to continuing to health and support patients with metastatic uveal melanoma. I will now turn the call over to David, who will review our portfolio updates. David?

David Berman: 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, we are also investing in an HLA version, which could enhance patient convenience. Our discovery engine has a pipeline of unique targets where we will push the boundaries of using TCRs to unlock solid tumors. And here, I’m delighted to present a novel TCR target called PIWIL1. PIWIL1 have several features reminiscent of PRAME, one of which is that it’s a negative prognostic marker, suggesting it has an important role in tumor progression. PIWIL1 has broad homogenous expression in about colorectal cancer patients.

And CRC historically has been insensitive to checkpoints, reminiscence of uveal melanoma. We believe the addressable population is 35,000 patients per year and an IND is planned for fourth quarter of this year. Our T cells scan for cancer, but they also scan for virally infected cells. And therefore, it was logical to apply our technology to attempt functional therapy HBV and HIV. Both have viral reservoirs where current therapy cannot remove or eliminate the residual virus. The goal of TCR by specifics are to eliminate these reservoirs. 113V, our HIV ImmTAC is potent at killing HIV infected CD4 T cells and works by recruiting the cytotoxic CD8 T cell to punch holes in the infected T cell. We opened a single ascending dose portion of the HIV trial last year and have had very strong enthusiasm in enrollment of people living with HIV who are stable on antiretroviral therapy.

The primary objective was safety and to identify a dose for the multiple ascending dose portion. We identified 15 micrograms as a dose that was well tolerated with no clinical cytokine release syndrome, but induced IL-6 in the blood. We have found in our oncology programs that IL-6 is a sensitive downstream biomarker of T cell engagement and redirection and this consistency from oncology to infectious disease is striking for us and provides reason to move to the MAD. We have now opened the MAD portion where participants living with HIV will receive 3 months of 113V on top of antiretroviral therapy. The primary endpoint of safety and to determine a Phase 2 dose, but we are very keen to also look at antiviral activity, including stopping the ImmTAC 113V and the antiretroviral treatment after 3 months to see if we can affect slow or decrease the kinetics and magnitude of HIV viral rebound.

We believe this trial should provide early POC for a functional care. I’ll now hand back to Bahija.

Bahija Jallal: 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.

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Q&A Session

Operator: Our first question comes from the line of Michael Yee with Jefferies.

Michael Yee: 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?

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

Brian Di Donato: 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.

David Berman: 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.

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

Unidentified Analyst: This is Nick 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?

Bahija Jallal: Great. Ralph, you can take that one.

Ralph Torbay: 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.

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

Unidentified Analyst: This is Tara 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?

Bahija Jallal: 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.

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

Patrick Trucchio: 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?

Bahija Jallal: 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?

Brian Di Donato: 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.

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

Justin Kim: With regards to the median 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?

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

Ralph Torbay: 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.