Genmab A/S Q2 FY2025 earnings call

• Accelerated development of high-impact late-stage pipeline, with Epcoritamab, Rina-S, and acasunlimab showing progress. - Epcoritamab's EPCORE FL-1 study met dual endpoints of progression-free survival and overall response rate in a preplanned interim analysis, supporting global regulatory submissions. - Rina-S data from the Phase I/II RAINFOL-01 study in advanced endometrial cancer was unveiled at ASCO, with plans to broaden its development into multiple Phase III trials. - Commercial performance: EPKINLY had $211 million in global sales, a 74% y-o-y increase; Tivdak had $78 million in global sales, a 30% y-o-y increase. - Financials: 19% total revenue growth, 56% operating profit growth, $3 billion in cash at the end of the first half.

Total revenue grew by 19% in the first half of 2025, fueled by increased recurring revenue. EPKINLY posted $211 million in global sales, a 74% year-over-year increase. Tivdak had global sales of $78 million, up 30% year-over-year. DARZALEX net sales grew by nearly 22% to $6.8 billion, contributing over $1 billion in royalty revenue. Recurring revenues represented 97% of total revenue in the first half of 2025, compared to 90% in the first half of the previous year.

• Revised revenue guidance to $3.5 billion to $3.7 billion, with a midpoint growth of 15%, up from previous guidance. - Recurring revenue growth expected to be 22%, up from 18% in previous guidance. - OpEx expected to be in the range of $2.1 billion to $2.2 billion. - Operating profit expected to be in the range of $1.1 billion to $1.4 billion, with a midpoint over $1.2 billion.

Q: Congrats on the positive Phase III EPCORE FL1 results. What is your latest thinking on the positioning of epco versus other CD20 bispecifics in the competitive landscape, both in terms of clinical development and your commercial experience?

A: Tahi mentioned a broad and aggressive development plan, with a head start in second-line follicular lymphoma, and accrual progress in frontline studies. Brad added on the strong sales position globally as the only off-the-shelf dual indication bispecific.

Q: So there is a lot of chaos at the FDA right now or calamity, whatever you want to call it. As we think about some of the regulatory filings you have coming up, I want to -- so I have a 2-part question on that. One, how confident do you feel that you can file RAINFOL-01 Part C, which is a single-arm cohort? How confident you feel you can file that for accelerated approval? And secondly, is there any risk of pushback from the FDA on EPCORE FL-1 to wait until OX is more mature?

A: Judith stated no reason to believe FDA pushback on RAINFOL-01 Part C for accelerated approval, and confident in path forward with EPCORE FL-1 as indication got BTD in September 2024 and sBLA accepted with PDUFA date in November.

Q: So firstly, on EPKINLY, so assuming you get the approval in November, could you just outline your initial launch strategy? Is there a specific patient group that you might be targeting? Or yes, and how should we think about revenue contribution in '25 and '26? And then just on the label there, do you expect that there will be no requirement for hospitalization? And then the second question was just on the pipeline. I noticed that the HexaBody-OX40 or GEN1055 has been discontinued in solid tumors. Could you just talk to the rationale here? And I think that's the second HexaBody asset now that's not been progressed this year. So it would be great to just hear your confidence in that platform? And could that OX40 asset be used in immunology potentially?

A: Brad commented on EPKINLY's launch strategy focusing on expanding into earlier lines of therapy. Tahi talked about discontinuing HexaBody-OX40 due to not being differentiated enough from other assets and prioritizing resources, and mentioned acasunlimab will use Q 6-week dosing as optimal.

Q: Now that follicular lymphoma is really a growing part of the conversation for EPKINLY, how are you thinking about EPKINLY's opportunity and differentiation versus [mosunetuzumab] specifically?

A: Tahi mentioned EPKINLY has a positive Phase III in second line with a head start, better efficacy, subcutaneous administration advantage, and lower CRS rates compared to [mosunetuzumab].

Q: I had another one on Rina-S and specifically around your plans for development outside ovarian cancer. You did talk about this new Phase II study in non-small cell lung cancer. And yes, just wondering if you could expand upon that opportunity. Do you have any data in-house, Phase I data in-house supporting this? And what do we know about the folate receptor alpha expression in lung cancer?

A: Tahi explained Rina-S's potential in non-small cell lung cancer due to folate receptor alpha expression, with a Phase II study exploring the opportunity in EGFR-mutated non-small cell lung cancer, and initial data showing encouraging signals.

Q: Congrats on the strong EPCORE FL-1 data. Maybe a question for Tahi. You mentioned the broad development plan with epcoritamab as being a strength. I was wondering what you think about ADC combinations. And do you see a role for those longer term in lymphoma, maybe how you will continue to explore those? And then quickly, acasunlimab in melanoma, will that use the same Q 6-week dosing? Or do you need to explore additional dosing regimens in melanoma?

A: Tahi discussed epcoritamab's development plan and combination with ADCs, and Judith confirmed acasunlimab will use Q 6-week dosing as optimal.

Q: I just have one follow-up question on the Rina-S in non-small cell lung cancer. Is the Phase II trial going to test Rina-S in patients in the first-line or second-line setting of the non-small cell lung cancer or all comers? And just a quick follow-up. Is the Rina-S going to be tested as monotherapy or in combination with other checkpoint inhibitors?

A: Tahi stated the Phase II study will interrogate Rina-S in monotherapy and combination therapy, but details on line of therapy and specific combinations were not fully disclosed.