Genmab A/S Q1 FY2026 earnings call

• Growth: Total revenue grew by 25% in Q1 2026, with continued momentum across the portfolio. Grew operating profits even with strategic investments. - Kinley-Courtain: Hospitalization recommendation removed from third-line plus relapsed or refractory diffused large B-cell lymphoma label, and on track with integration of mirrors. - RINA-S: Data presented at STO in April supported its promise, including in combination with Bevacizumab. Anticipate starting two new Phase III trials for RNA-S in coming months, including a Phase III chemoreplacement trial in platinum-sensitive ovarian cancer and first frontline trial in endometrial cancer. Phase III RAINFALL-02 trial in second-line plus platinum-resistant ovarian cancer completed enrollment, bringing forward pivotal Phase III data into 2026. - Epkinley: Continued to gain traction, grew 52% year-over-year globally, with recent label change in U.S. expected to broaden use. - TIBDAC: Grew 18% year-over-year, leading the market in U.S., with encouraging progress in newer launch markets and working to expand patient access in U.K. and prepare for additional launches in key European markets.

Total revenue grew by 25%. Sales for the quarter totaled $176 million, representing 43% growth compared to Q1 last year. Epkinley grew 52% year-over-year, reaching $137 million in sales. TIBDAC grew 18% year-over-year, reaching $39 million in sales in the quarter. Revenue growth was driven by strong royalties from Darzalex and Cosimta, and product sales from own medicines like Epkinley, diversifying the revenue base.

• Revenue: Expect 14% total revenue growth at midpoint, driven by continued momentum in Epkinley and royalty portfolio. - Operating expenses: Expected to be in range of around $2.7 to $2.9 billion, reflecting planned investments to advance late-stage development for Pitocentamab and Rina S, and launch readiness activities. - Tax: Currently evaluating integration of merits operations from tax perspective, effective tax rate may experience volatility but expected to normalize within 12 to 18 months. - Leverage: Targeting gross leverage below three times by end of 2027 while maintaining balance sheet strength and flexibility.

Q: On the frontline pedosymptomab head and neck cancer study, it looks like the size of the study has been increased. Can you discuss the rationale behind any changes to the study and implications of those changes?

A: Thay said they increased the study size to ensure highest probability of success, details not discussed in public space, and changes won't impact timelines and stay with guidance of one or both PATO studies reading out this year.

Q: Follow-up on previous question about increased size of first-line trial, why it doesn't impact timing, enrollment progress, and whether it's for HPV-negative patients?

A: Tai said increase was to ensure appropriate data for probability of success, won't change timelines, and didn't comment on enrollment progress or HPV-negative patients specifically.

Q: On re-nurse, 01 and 02 coming in H2, will report as separate results, and if phase two is positive will file without waiting for phase three? And on B7H4 ADCs vs FOLA ADCs in gynecological cancers?

A: Judith said phase 3 accrued ahead of projections, stay behind guidance of RHNA-S launch in PROC in 2027, and stand behind strength of RINA data in competitive landscape.

Q: On Epkinley frontline DL-BCL trials, expected change in hazard ratio in typical PFS curve and impact of 30% cap on IPI stage 2 patients?

A: Tai said can't comment on hypothetical hazard ratio changes, and cap is 30% but didn't comment on actual demographics or impact on powering and timing.

Q: On AppKindly, relevant benchmark for AppCode DLBCL4 second-line trial and if new RINA-S trial is K-truda combination?

A: Thij said 128 study compares against RGEMOX, intent is to generate patient-friendly regimen, and Judith said combination with Bev is ongoing and others are actively enrolling.

Q: On EPCOR DLBCL2 enrollment relative to expectations and confidence in fixed duration paradigm replicating Phase II data?

A: Tai said trials accrued faster than projected, feel confident fixed duration paradigm doesn't impact ability to achieve CR and MRD negativity.

Q: On sequencing of drugs through lines of therapies in DLBCL, preference for biospecifics upfront?

A: Tai said sequencing is function of efficacy and safety, and Brad said physicians value bispecifics in earlier lines for convenience.

Q: On PITO Phase 2 OS rates, directional comment on OS curve and timeline of data; and on RENA-S in second line endometrial timelines?

A: Tai said will update phase two data but more meaningful is phase 3, and Judith said phase three is actively enrolling but no guidance on readouts.

Q: On PETO as it relates to CRC development, timing for announcements and other mechanisms to combine with beyond chemo?

A: Tai said will update closer to public domain, and there are interesting things in combination with PETO.

Q: On fetal symptomatic enrollment, breakdown of patients by baseline characteristic and change in ORR analysis?

A: Tai said increase in study size intended to increase probability of success, no impact on timelines.

Q: On LIGER program, filing with both studies and timeline of data by year end?

A: Tai said guide one or more studies to read out this year, won't comment on which first.

Q: On epkinley, key features driving enthusiasm in first-line setting as per survey?

A: Tai said CD3C20 mechanism, safety profile, subcutaneous administration, and time advantage in readout drive enthusiasm.

Q: On Epkinley Q1 performance driven by recent label change in U.S. and hurdles to further penetration?

A: Brad said strong start driven by efficacy, safety, subcutaneous administration, and hospital removal update, and looking to remove barriers.

Q: On EPCMLE EPCOR DLVCL2 trial, PFS hazard ratio for clinical meaningfulness and OS benefit for commercial uptake?

A: Tai said can't speculate on hazard ratio, and OS benefit is function of PFS effect size.

Q: On PDO trial upsizing, whether upsizing occurs at already enrolled centers and adding investigation sites?

A: Tai said amendment had no impact on additional sites or need for additional sites, study enrolling well