Genmab A/S Q3 FY2026 earnings call

• Unprecedented Phase 3 Success: October marked a historic month with three positive Phase 3 readouts across different programs: Epkinley (DLBCL), Rina-S (Ovarian Cancer), and P2-centimab/Speedosymptomab (Head and Neck Cancer). All results were consistent with earlier Phase 2 data.
• Epkinley Leadership: Remains the most prescribed bispecific antibody in lymphoma globally. Strong uptake in the US community setting and new launches in Japan for second-line follicular lymphoma (FL).
• Rina-S Potential: Positive Phase 3 data in platinum-resistant ovarian cancer supports its ambition to be the best-in-class therapy. The program has broad potential across gynecologic cancers including endometrial cancer.
• P2-centimab Expansion: First positive Phase 3 trial in first-line head and neck cancer in nearly a decade. Expanding into colorectal cancer with two ongoing Phase 3 trials.
• Commercialization Engine: GENMAP has built a robust commercial infrastructure capable of scaling with its growing portfolio, focusing on access, adoption, and launch readiness for upcoming approvals.
• Strategic Execution: Management emphasizes disciplined capital allocation, investing heavily in late-stage development and launch readiness while maintaining profitability and aiming for gross leverage below three times by the end of 2027.

The provided transcript does not explicitly break down financial performance by specific product segments (e.g., Oncology vs. Other) with distinct revenue contribution percentages for each. However, it highlights the following key revenue drivers:

• Darzalex: Revenue increased 19% year-over-year, contributing approximately half of the total year-over-year revenue growth.
• Epkinley: Net product sales reached $491 million in the first nine months, a 47% increase year-over-year.
• Tibdac: Sales totaled $131 million in the first nine months, a 9% increase year-over-year.
• Remainder of Portfolio: Increased 30% year-over-year, generating the other half of the total revenue growth alongside Epkinley.
• Total Revenue: Grew 22% year-over-year for the first nine months of 2026.

• 2026 Revenue Guidance: Maintained at a range of $4.325 billion to $4.525 billion (midpoint reflects ~19% growth). Management now expects revenue to land in the upper part of this range due to strong momentum from Epkinley and royalties.
• 2026 Operating Expenses (OPEX): Maintained at a range of $2.81 billion to $2.95 billion, with an expected midpoint of ~$2.88 billion. Q4 OPEX is expected to step up significantly due to manufacturing, clinical development, and launch readiness activities for Rina-S and P2-centimab.
• 2026 Adjusted Operating Profit: Projected range of $1.065 billion to $1.35 billion (midpoint >$1.2 billion). With revenue in the upper range and OPEX near the midpoint, management expects operating profit to exceed the midpoint.
• 2027 Outlook: While specific guidance will be released in February 2027, management expressed confidence in delivering strong profitability in 2027 and continued growth, supported by consensus expectations for OPEX that align with their investment priorities.

• Regulatory and Development Risks: Forward-looking statements acknowledge that actual results may differ materially due to delayed or unsuccessful development projects. Specific risks include the need for confirmatory Overall Survival (OS) benefits in certain trials (e.g., DL-BCL-4) to secure regulatory approval.
• Safety Signals: Minor increases in grade five events were noted in some trials, though management stated there are no isolated safety signals. Long-term safety profiles and durability of response remain areas of monitoring.
• Competitive Landscape: The oncology market is described as highly competitive and data-driven. Competitors like Polarchip (Polatuzumab vedotin + Rituximab + Cyclophosphamide + Doxorubicin + Prednisone) and Amivantamab present competitive pressures, particularly in frontline settings and colorectal cancer.
• Tax Rate Fluctuation: The effective tax rate may continue to fluctuate as integration activities from the Meris acquisition progress, though normalization is expected over the next 12-18 months.
• Launch Execution Risk: Success depends on the ability to execute successful commercial launches for multiple new products (Epkinley in earlier lines, Rina-S, P2-centimab) simultaneously, leveraging existing infrastructure.

Q: Benjamin Jackson asked about the OS hazard ratio in the DL-BCL-4 abstract, whether COVID-related deaths needed adjustment, if the short follow-up affects confirmatory status, and regarding safety signals (grade 5 events).

A: CMO Tahy Ahmadi explained that the 10-month follow-up is immature compared to prior trials (28-30 months), so OS data is not yet mature. COVID is not a major factor as trials were post-pandemic. The frontline DLBCL trial with overwhelming PFS benefit will serve as the confirmatory trial. Regarding safety, there were few death events on both arms with no isolated signal; multifactorial causes exist, and full data will be presented at ASH.

Q: Charlie Highwood asked if the positive OS data for P2-centimab increases confidence in the $1 billion sales target by 2029 and how the smaller halo indications (second/third line head and neck, endometrial) compare commercially to anchor readouts.

A: CFO Anthony Pagano reaffirmed high conviction in the multi-billion peak sales estimate for P2-centimab and specifically the $1 billion by 2029 target, backed by the strong Phase 3 results. CMO Brad Bailey noted that while these indications are smaller, they broaden the patient pool and reinforce the asset's value, with confidence in the commercial capabilities to capture this opportunity.

Q: Zain Abraham asked about the expected duration of treatment for P2-centimab given the doubling of OS vs. PFS, and the pace of rollout for Epkinley in first-line DLBCL, questioning if blockbuster sales are possible next year.

A: CMO Tahy Ahmadi declined to discuss nuanced modeling details until public data release but emphasized the transformative nature of the study. CMO Brad Bailey stated that first-line is the largest opportunity where patients are treated in the community. He expressed confidence in strong uptake at launch, driven by academics initially and then expanding to the community, validating the potential for significant sales growth.

Q: Karina (on behalf of Astika Gunnubadene) asked if Rina-S still qualifies for accelerated approval given SAC-TNT’s modest response rate and stromatitis, and if the positive ovarian data impacts recruitment for other Rina-S studies.

A: Chief Development Officer Judith Klimovsky clarified that for endometrial cancer, the filing will likely be based on the Phase 3 randomized study rather than accelerated approval from single-arm data. She added that the unprecedented results in ovarian cancer create a 'halo effect' that encourages recruitment into other ongoing Phase 3 and basket studies.

Q: Sean Beng asked about the subcutaneous formulation timeline for P2-centimab, its positioning against Polarchip in frontline DLBCL, and the role of Rina-S in maintenance settings for ovarian/endometrial cancer.

A: CMO Tahy Ahmadi highlighted Epkinley’s unprecedented hazard ratio (0.49), time advantage over competitors, and sub-Q administration/dual indication as key differentiators for community adoption. For Rina-S, she explained that its toxicity profile (mainly myelosuppression early on) makes it well-tolerated for long-term maintenance use, unlike drugs with cumulative neurotoxicity or ILD risks, supporting its inclusion in maintenance strategies.