Immunocore Holdings Plc Q4 FY2024 earnings call

• Bahija Jallal highlighted 2024 as a year of strong execution, with KymTrak delivering growth, progress in the clinical pipeline including three ongoing phase three trials, initiation of two phase one trials, completion of HBV single ascending dose trial, and advancement of autoimmune candidates.
• Ralph Torbay discussed KymTrak's commercial success, global expansion, lifecycle management plans, and details of the TEBIAM phase three trial in second-line metastatic cutaneous melanoma.
• David Berman provided pipeline updates, including on Frame in melanoma, HIV trial progress with upcoming data, and details of autoimmune candidates for type 1 diabetes and atopic dermatitis.
• Travis Coy shared financial highlights for 2024, noting SG&A and R&D expense increases, and provided 2025 guidance on KymTrak revenue growth, R&D and SG&A expense expectations, and the company's strong cash position.

KymTrak was the key segment. In 2024, KymTrak generated $310 million in revenue, marking a 30% year-on-year growth. In the fourth quarter, it reported $84.1 million in net revenues, a 5% increase from the prior quarter. The revenue growth was driven by volume growth in the US and continued launches outside of the US. KymTrak accounted for a significant portion of the company's overall revenue, with its commercial success contributing to the firm's financial performance for the period.

• For KymTrak, revenue is expected to grow incrementally in 2025, led primarily by growth in the US through community setting penetration and growth from launches in the EU and international markets.
• R&D expenses are anticipated to increase relative to 2024 as the company further advances its clinical and preclinical pipeline candidates.
• SG&A expenses are expected to be mostly consistent with Q4 2024 levels over 2025, with typical quarterly variability.

• Reimbursement challenges in Europe for KymTrak, as the company continues to finalize price negotiations and navigate a challenging reimbursement environment.
• Uncertainties related to clinical trial outcomes, including the need for sufficient data in phase three trials to determine next steps, and potential delays or setbacks in trial enrollments and data readouts.

Q: Michael Yee asked about the upcoming HIV results, specifically regarding the sixteen patients in the trial and European sales.

A: David Berman responded on the HIV trial that all patients will be off therapy and entered the ATI, and he discussed what a good rate of viral control would look like. Ralph Torbay addressed European sales, stating challenges in the reimbursement environment and ongoing price negotiations in Germany and France.

Q: Jessica Fye inquired about HIV dose selection and next steps.

A: David Berman explained that factors for selecting the go-forward dose include tolerability and evidence of antiviral activity, and mentioned that after dose escalation, they would move to an expansion and potentially a randomized phase two trial.

Q: Tyler Van Buren asked about the twelve-week time point in the HIV trial and KOL feedback.

A: David Berman stated that twelve weeks is used to get initial evidence of activity, and referred to a meta-analysis for what a commercially successful target product profile looks like.

Q: Eric Schmidt asked about branetafus dose selection and phase one data.

A: David Berman said the ninety-patient dose selection analysis follows patients for 8-12 weeks to assess safety and initial response rate.

Q: Jonathan Chang asked about business development opportunities in 2025.

A: Travis Coy mentioned the company is excited about its pipeline and continuously looks for strategic business development opportunities that leverage its expertise and capabilities.

Q: Michael Schmidt asked about KymTrak's US market penetration and treatment duration.

A: Ralph Torbay said KymTrak has 65% market penetration in the US and is continuing work in the community setting, and he noted treatment duration is trending over twelve months but difficult to predict long term.

Q: Nick Lenard asked about branetafus dose selection metrics and futility analysis.

A: David Berman said there will be no futility analysis, the IDMC will use efficacy and safety to select the dose, and they'll use modeling if large differences aren't seen.

Q: Ethan Markowski asked about reimbursement challenges for branetafus in Europe.

A: Bahija Jallal and Ralph Torbay discussed ongoing negotiations in Europe and the company's track record with KymTrak, expressing hope for similar success with branetafus.

Q: Peter Lawson asked about HIV program success metrics.

A: David Berman said success in the HIV program would be showing signals of activity like reservoir reduction and viral control after interruption, and details on doses and expansion were provided.

Q: Patrick Trucchio asked about HIV combination strategies and regulatory incentives.

A: David Berman mentioned the program is combinable with LRAs and discussed potential regulatory interactions but noted data needs to be generated first.

Q: Rajan Sharma asked about atopic dermatitis benchmarks and HIV data crossover to HBV.

A: David Berman talked about atopic dermatitis initial entry points and the importance of HIV and HBV data for validating the platform in infectious diseases.

Q: David Dye asked about preclinical data supporting HIV viral control.

A: David Berman highlighted preclinical data showing the molecule can redirect T cells to kill HIV-infected CD4 T cells and bridging of T cells to infected cells.

Q: Jeff Hung asked about applicability of autoimmune program to oncology.

A: David Berman explained the common tissue targeting aspect but differences in effector mechanisms between oncology (activating T cells) and autoimmune (turning off T cells) were noted