Genmab A/S Q4 FY2025 earnings call

Jan van de Winkel mentioned that in 2025, Genmab delivered on commitments to accelerate late-stage pipeline development, maximize commercialized medicines' potential, and allocate capital. Highlights included EPKINLY's positive momentum, FDA approval in second-line follicular lymphoma, expansion of Rina-S development with 3 Phase III trials, and acquisition of Merus enhancing the late-stage portfolio. Brad Bailey discussed commercial performance, with EPKINLY showing strong growth across geographies and TIVDAK performing well in various markets. Anthony Pagano talked about 2025's strong execution, revenue growth, improving revenue profile, and 2026 guidance focusing on revenue growth, strategic investments, and maintaining profitability.

In 2025, total revenue grew by 19%. Sales of proprietary medicines totaled $632 million, up 54% year-over-year, accounting for approximately 28% of total revenue growth. EPKINLY achieved $468 million in sales in 2025, a 67% year-over-year increase, with regulatory approvals in more than 65 countries. TIVDAK generated $164 million in sales in 2025, a 26% year-over-year increase.

Genmab expects 14% total revenue growth in 2026, driven by momentum in EPKINLY and royalty portfolio. Operating expenses increase reflects planned investments for late-stage development and launch readiness. Midpoint of operating profit for 2026 is $1.15 billion. Commitment to deleveraging, targeting gross leverage below 3x by end of 2027.

Q: Discuss next steps for EPKINLY following EPCORE DLBCL-1 study results, ability to get second line plus label with EPCORE DLBCL-4 combination study, and rationale for monotherapy study as confirmatory.

A: Tahi Ahmadi discussed regulatory discussions, protocol prespecified analyses, and that other Phase III studies are ongoing.

Q: Update on EPCORE outpatient data adaptation to U.S. practice change and likelihood of convincing regulators to use other EPCORE Phase III study readouts as confirmatory.

A: Tahi and Brad Bailey addressed outpatient data as an enabler and confidence in having multiple confirmatory studies.

Q: On Rina-S, what determines Phase II readout and status of EPKINLY frontline DLBCL trial.

A: Judith Klimovsky discussed Phase II design for Rina-S and Tahi mentioned EPKINLY frontline trial readout expected in 2026.

Q: Expectations for EPCORE DLBCL-4 trial and clinically meaningful outcome relative to LUNSUMIO and POLIVY.

A: Tahi Ahmadi said trial is expected to be positive and lead to registration.

Q: Thoughts on pembro approval in PROC and implications for Rina-S, and DARZALEX trajectory.

A: Judith Klimovsky commented on pembro approval and Rina-S's potential.

Q: Thoughts on EPKINLY in first-line DLBCL trial OS benefit, efficacy bar, and MONJUVI frontline trial.

A: Tahi Ahmadi discussed expectations on PFS and OS, and Phase III study design.

Q: Clarification on EPKINLY first-line DLBCL trial events tracking and Merus acquisition trial design for peto.

A: Tahi and Judith Klimovsky addressed events tracking and trial design.

Q: Expectation of Phase I/II data update for peto in head and neck cancer and duration metrics.

A: Judith Klimovsky mentioned last ASCO presentation and data sensoring.

Q: Petosemtamab Phase II trial in first-line non-small cell lung cancer.

A: Judith Klimovsky commented on the trial.

Q: Phase III for peto in 2026 and colorectal cancer cohorts.

A: Judith Klimovsky discussed data growth and clinical development plan.

Q: Early-stage pipeline, priorities, and potential M&A.

A: Jan van de Winkel and Tahi Ahmadi discussed pipeline, INDs, and internal capabilities.

Q: Additional information needed for petosemtamab peak sales potential.

A: Anthony Pagano discussed multibillion-dollar potential and focus on data and CDP.

Q: Size of Rina-S opportunities and debt offering terms.

A: Anthony Pagano discussed Rina-S's peak sales guidance and debt offering details.

Q: Sales and marketing investments needed for potential launches.

A: Brad Bailey discussed disciplined OpEx and strategic investments.