Immunocore Holdings plc (IMCR) Q4 2024 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

Despite increased R&D expenses and competition, the company showed strong revenue growth (30% YoY), a solid cash position, and successful loan repayment. The Q&A highlighted ongoing developments and market penetration, with analysts showing interest in future prospects. The company's financial health and optimistic guidance, along with a market cap under $2 billion, suggest a positive stock price movement.

Key Financial Performance

Total Revenue $310 million for the year, representing a 30% year-on-year growth.

Q4 Revenue $84.1 million, representing a 5% increase from the prior quarter.

U.S. Revenue $226 million, growing at an impressive 34% year-on-year.

R&D Expenses Increased due to investments in three Phase III trials and Phase I/II cohort expansions.

SG&A Expenses Increased slightly due to general business functions needed to support operations.

Cash Position $820 million in cash and marketable securities at the end of the year.

Loan Repayment $50 million loan with Pharmakon was repaid in November.

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Operating Highlights

KIMMTRAK Revenue: KIMMTRAK generated $310 million in net revenues for the year 2024, representing a 30% year-on-year growth.

KIMMTRAK Q4 Revenue: In Q4 2024, KIMMTRAK reported $84.1 million in net revenues, a 5% increase from the prior quarter.

KIMMTRAK Market Expansion: KIMMTRAK has been launched in 14 new countries in 2024, totaling 39 countries approved, including recent approvals in Brazil, U.K., and Poland.

KIMMTRAK Patient Treatment: In 2024, KIMMTRAK successfully treated two out of three patients in the community, with nearly half of new patients starting treatment there.

Market Penetration: KIMMTRAK has an estimated market penetration of around 65% in the U.S.

Global Expansion: KIMMTRAK is now established as standard-of-care across most major markets with over 80% share of HLA-A 201 positive patients.

Phase III Trials: Immunocore advanced three ongoing Phase III trials, including TEBE-AM and ATPM for melanoma, and randomized the first patient in the PRISM-MEL trial.

R&D Pipeline: In 2024, Immunocore initiated two Phase I trials with novel molecules and completed the HBV single ascending dose trial.

Strategic Focus: Immunocore is expanding into autoimmune diseases with two candidates targeting type 1 diabetes and atopic dermatitis.

Financial Position: Immunocore ended 2024 with $820 million in cash and marketable securities, indicating a strong financial position.

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Risk or Challenges

Regulatory Issues: The reimbursement environment in Europe remains challenging, impacting revenue recognition as price negotiations are finalized.

Supply Chain Challenges: No specific supply chain challenges were mentioned, but the overall context of expanding operations and launching products in multiple countries may imply potential risks.

Competitive Pressures: The company faces competition in the oncology market, particularly in the second-line metastatic cutaneous melanoma setting where patient survival rates are poor.

Economic Factors: The company anticipates increased R&D expenses due to investments in clinical trials, which may impact financial performance.

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Guidance & Outlook

KIMMTRAK Revenue Growth: Achieved $310 million in total revenue for 2024, representing a 30% year-on-year growth.

Phase III Trials: Advanced three ongoing Phase III trials, including TEBE-AM and ATPM, and randomized the first patient in the PRISM-MEL trial.

Expansion into Autoimmune Diseases: Initiated two Phase I trials targeting type 1 diabetes and atopic dermatitis.

Global Expansion of KIMMTRAK: Launched KIMMTRAK in 14 countries, now approved in 39 countries, with a focus on community expansion.

2025 KIMMTRAK Revenue Expectations: Expect incremental growth in KIMMTRAK revenue, primarily driven by U.S. community expansion and new launches in international markets.

R&D Expenses for 2025: Anticipate R&D expenses to increase relative to 2024 due to advancements in clinical and preclinical pipeline candidates.

SG&A Expenses for 2025: Expect SG&A expenses to remain consistent with Q4 2024 levels, with typical quarterly variability.

Cash Position: Reported $820 million in cash and marketable securities at the end of 2024.

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Shareholder Return Plan

Cash Position: $820 million in cash and marketable securities at the end of the year.

Loan Repayment: Repayment of $50 million loan with Pharmakon in November.

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Key Q&A

Q:In the 16 patients, would they all have 12 weeks or so off therapy, off all the therapy?

A:Yes, all patients will have been off of therapy and entered the ATI and all will have been available to see whether there is antiviral activity and, of course, whether there is a viral reservoir reduction during the treatment phase.

Q:What rate of patients not rebounding would you deem to be good?

A:I wouldn't focus necessarily on rate at this point. I think we need to get to a top dose and then expand. Essentially, it is copies -- they would like to see suppression of viral copies to less than 200 copies per ml for two years in about 20% to 30% of people.

Q:Can you elaborate on what factors are going to help you determine a go-forward dose?

A:In terms of the factors we would use to select the go-forward dose, of course, safety. This is a relatively healthy population. So it needs to be a well-tolerated regimen. We need to see evidence of antiviral activity.

Q:Is 12 weeks of patients being controlled following ART interruption enough to have confidence that they would maintain control over the longer term?

A:The 12 weeks is historically being used in these initial Phase I trials to get a sense of whether you have any activity because the percentage of people who will have viral control at 12 weeks is about 1%. So it's extremely low.

Q:What kind of follow-up will you have in terms of duration for the first 90 patients in the PRISM-MEL study?

A:Those patients will be followed up for between 8 and 12 weeks.

Q:What would be the minimum commercially successful TPP in infectious disease settings?

A:In terms of infectious disease, we would expect to see mild cytokine release syndrome, and we think that's really achievable.

Q:Can you provide an update on the current efforts to generate data in ovarian and lung cancers?

A:With ovarian, we're building up the initial signals. In the lung setting, we're more in the signal detection phase.

Q:How are you thinking about business development opportunities for 2025?

A:We do continuously look for opportunities to enhance the value of the portfolio. Those opportunities need to be a good strategic fit.

Q:How much additional headroom do you see in the US market for KIMMTRAK?

A:We are at 65% penetrated, which is good news because we've been growing significantly, 34% growth last year in the US.

Q:What metrics do you expect the IDMC will use to make a dose selection decision?

A:The IDMC will use both efficacy and safety.

Q:Do you anticipate similar reimbursement challenges for brenetafusp in Europe?

A:The reimbursement landscape is challenging for all companies.

Q:How should we be thinking about the bar for success for the upcoming HIV data?

A:What we're looking for in a Phase I dose escalation is do we have signals of activity? Can we reliably reduce the reservoir?

Q:Could you highlight some of the preclinical data that gives you confidence of potential viral control for the Phase I trial?

A:We've shown that this molecule can redirect T cells to kill HIV-infected CD4 T cells.

Q:How are you thinking about applicability of the autoimmune program to the oncology programs?

A:What they have in common is the tissue targeting part that we can show exquisite tissue targeting with our cancer program.

Q:Review of Unclear Management Responses

A:Management avoided giving a direct answer regarding the specific timeline for sharing data on the ovarian and lung cancer studies, stating they would share data when there is a complete understanding of what's going on. Additionally, there was a lack of clarity on the exact metrics the IDMC would use for dose selection, as they mentioned modeling would be involved without specifying further.

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Earnings Word Cloud

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