Genmab A/S

Hello and welcome to the GenMAP first half 2025 financial results conference call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as beliefs, anticipates, plans, or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. GenMav is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless this is required by law. Please also note that GenMav may hold your personal data as indicated by you as part of our investor relations outreach activities in order to update you on GenMav going forward. Please refer to our website for more information on GenMav and our privacy policy. I would now like to hand the conference over to our first speaker today, Jan van der Winkel. Please go ahead.

Hello, and welcome to our financial results call for the first nine months of 2025. With me today is our Chief Financial Officer, Anthony Pagano, our Chief Commercial Officer, Brad Bailey, and our Chief Medical Officer, Taya Mahdi. And for the Q&A, we will be joined by our Chief Development Officer, Judith Klimowski. As noted, we will be making forward-looking statements, so please keep that in mind. During today's presentation, we will reference products being developed under some of our strategic collaborations, and this slide acknowledges those relationships. As we near the end of 2025, I would like to remind you of the commitments that we made at the beginning of the year. We said that we would accelerate the development of a high-impact late-stage pipeline that we would maximize the potential of our commercialized medicines, and that we would deliver on our capital allocation priorities. I'm pleased to say that we are following through on these commitments, supporting our continued growth and long-term value creation. Over the past nine months, our total revenue grew by 21%, fueled by increased recurring revenue. and we have invested fully in line with our capital allocation priorities. Importantly, we have grown operating profit by 52% even while making these strategic investments. We ended the first half with around $3.4 billion in cash. Our strong financial foundation has given us the flexibility for continued growth and expansion through investment in our high-impact late-stage programs. Abkinli and Rina S have both progressed rapidly over the course of this year with extremely encouraging data sets. And for Rina S, we have initiated additional phase three clinical trials. As part of our disciplined investment into the highest potential programs, together with BioNTech, we have agreed that the current data in frontline head and neck cancer for Gen 1042 did not meet our high bar for continued development. As part of our capital allocation priorities was our promise to explore focused M&A opportunities. We have delivered on this commitment with the potentially transformative proposed acquisition of Meris. So let's briefly review the highlights. The proposed acquisition of Meris is an exceptional opportunity that advances our evolution into a global biotech leader. It accelerates our shift towards a 100% owned model It expands and diversifies our revenue, and it brings us closer to achieving our 2030 vision to improve the lives of patients. With this proposed acquisition, we will add PaetoSymptomUp, or Paeto, to our already compelling portfolio. High-potential assets like Paeto, which has received two breakthrough therapy designations, are truly rare. The totality of data we have seen for PATO underscores the potential as a best-in-class EGFR bispecific across head and neck cancer indications, as well as in other EGFR-expressing tumors. And with data anticipated in 2026 from one or both of the ongoing Phase III trials, we expect PATO will also be first-in-class, with an initial launch expected in 2027. We are confident that our expertise and leadership in antibody-based innovation, as well as our swift and broad clinical development of both APKinley and RENAS, demonstrate our ability to fully realize PETOS potential. We will also see real promise for it to join APKinley and RENAS as multi-billion dollar program. We expect to close the acquisition by early in the first quarter of 2026, subject to the satisfaction of customary closing conditions. And combined with our disciplined capital allocation, strong financial foundation, and proven commercial execution, this transaction sets us up for durable long-term growth into the next decade. Now let's turn to some of the recent advancements for our late-stage programs. Beginning with Upkinley. We eagerly await its potential approval in second-line follicular lymphoma later this month. In addition to the unprecedented phase 3 second-line follicular lymphoma data we discussed during our second quarter call, recently we announced updated results for abcaritumab in the outpatient setting. These data evaluated the feasibility of treating and monitoring patients with relapsed or refractory diffuse large piece of lymphoma in this setting. Data from both the Phase III second line and outpatient studies are included in more than 20 EPCOR abstracts that have been accepted for presentation at this year's ASH meeting end of the year. Excitingly, the second line follicular lymphoma data will be one of seven oral presentations for EPCOR at ASH. These abstracts highlight advances that expand abcaritumab's clinical profile, supporting use in earlier lines of therapy, and across additional B-cell malignancies. So now let's turn to RENA-S. Last month at ASMO, we presented an update of the data for single-agent RENA-S in patients with advanced endometrial cancer. Today, Ty will provide a brief overview of this data, which further supports the encouraging results that we showed at ASCO. This progress reflects our vision to accelerate our innovative late-stage pipeline and shows additional momentum behind the possibilities of RINA-S. Our confidence in the potential of RINA-S in endometrial cancer is reinforced by the Breakthrough Therapy designation granted by the US FDA. As a reminder, this indicates that the FDA considers RINA-S to have the potential to significantly improve patient outcomes compared with existing therapies. The data we have seen, and the recognition from the FDA, both support our development plans for RENAS. And I am pleased to tell you that we have initiated a phase three trial in endometrial cancer. So our rapid development of RENAS continues. And we are also preparing for potential commercialization. TifTac is now available for prescribing in Germany, our first European market. And the foundation that we are building in the European Guyana community with TIFTAC will set us up for future success with RINA-S. Now over to Thay and the updated RINA-S data from ESMO. Thay, go ahead.

Thank you, Jan. At ASCO, we presented the first results for single-agent RINA-S in patients with advanced endometrial cancer from the ongoing Phase I-II Rainfall-01 study. And at ESMO, just a few weeks ago, We provide an update on that data with four additional months of follow-up. What we saw was that at a median follow-up of around a year, reNA-S dose at 100 mg per meter squared showed deep and durable responses regardless of foliar receptor alpha expression. The disease control rate at that dose continuing to be at 100% and a confirmed ORR remaining at 50%, including two complete responders. and with seven out of the 11 confirmed responses still ongoing at that data cutoff. This compares to the standard-of-care chemotherapy, which delivers approximately a 15% OR and a limited durability roughly around six months. In addition to the durable efficacy, reNA-S continues to have a manageable safety profile. There are still no signals of ocular toxicity, interstitial lung disease, or neuropathy across the entire program. So in summary, the data we have seen for vena S, both in endometrial cancer and the data we've presented on clock, reinforce our conviction that vena S is best in class ADC across efficacy, safety, and durability across the entire spectrum of folate receptor alpha expression. And we are maximizing its potential with an accelerated and extremely comprehensive development plan that includes Now, three ongoing Phase 3s, if you follow today's disclosure on clinicaltrials.gov, and two Phase 3s that are intended for potential registration under the accelerated approval pathway in the United States, one in PARCC and one in second line endometrial cancer. And we expect a first launch in 2027, and we also are generating data beyond Gynonc with signal-seeking Phase 2 trial in non-small cell lung cancer. And now over to Brad for a review of the recent commercial performance for Epkinley and Tiftac.