Genmab A/S

Hello and welcome to the GenMAP full year 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. GenMAP 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, GERMAP may hold your personal data as indicated by you as a part of our investor relations outreach activities in order to update you on GERMAP going forward. Please refer to our website for more information on GERMAP 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 2025. With me today is our Chief Financial Officer, Anthony Pagano, and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tanya Mahdi, and our Chief Development Officer, Judith Klimovski. As noted, we will be making forward-looking statements, so please keep that in mind. As we reflect on 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 our 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 have delivered on these commitments. And we begin 2026 with a diversified, high-quality revenue base and a late-stage portfolio that can drive sustainable growth well into the 2030s. In 2025, we grew total revenue by 19%, fueled by both our royalty portfolio and sales from our own medicines. And we also invested fully aligned with our capital allocation priorities. Importantly, we have also grown operating profit, even while making these strategic investments. 2025 was marked by some significant milestones in our mission to deliver innovative medicines to patients. Highlights include positive momentum for Epkinley as it continues to demonstrate the potential to become a core therapy in B-cell lymphomas, its FDA approval in second-line follicular lymphoma in combination with R-squareds, as well as the unprecedented data in this indication, are key milestones. Taken together, these move treatment into earlier lines of therapy and expand our impact for people living with follicular lymphoma. We also built on our commitment to the Gynonc community. In addition to the availability of TIFDAC in both Japan and Europe, we expanded the development of RENAS, ending the year with three phase three trials across PROC, and Demetrio Cancer and PSOC. Finally, a pivotal step on our journey to sustainable diversified growth was our acquisition of Meris. It's enhanced our late-stage portfolio with P2 Centum Up. P2 Centum Up, with P2 Centum Up joining up Kinley and Rinas, we have a strong pipeline of late-stage assets that will provide us with multiple value-creating catalysts in 2026 and in the future. Now let's take a look at the strength of these three programs on the next slide. With our five combined breakthrough therapy designations, these three programs have multi-billion dollar potential, and they firmly underpin our long-term growth. APKinley is currently the only bispecific antibody with a dual indication across B-cell malignancies in the US, Europe, and Japan. And following unprecedented data, APKinley plus R squared is well-positioned to become a best-in-class option in second-line plus follicular lymphoma. RENA-S is a folate receptor alpha-targeted ADC designed to broaden eligibility beyond high expressors. Based on current expression distributions, this could expand the addressable population by as much as three times versus approved medicines that are restricted to high folate receptor alpha expression. And finally, p2-centimab, a potentially transformative EGFR-LGL5 bispecific antibody with compelling data in both first-line and later-line recurrence and metastatic head and neck cancer. As a reminder, in the first-line setting, p2-centimab in combination with PEMBRO achieved a 63% response rate, and that is more than three times higher than the 19% that has been observed at the standard of care. 2026 will be a defining year for all three of these programs, as we will see on the next slide. We expect up to six potentially registrational data readouts that could set the stage for multiple important product launches at line extensions in 2027. In the second half of the year, we expect Phase II data for RhinAS and platinum-resistant ovarian cancer. We also anticipate that one or both phase three trials for P2 centromab in first and second line or third line head and neck cancer will deliver top line data in the second half. And while we anticipate around 25,000 potential patients for later lines of therapy in first line head and neck cancer, this increases to an additional 41,000 patients. For Hapkinley, we anticipate data from two phase three trials in diffuse large B-cell lymphoma. The indication with the largest addressable patient population, around 70,000 people, is, of course, frontline diffuse-slash-B-cell lymphoma. And we are looking forward to data in this indication in combination with our CHOP this year. We are also looking forward to data in the first half of the year in second-line-plus diffuse-slash-B-cell lymphoma in combination with lenalidomide. As you are aware, in January we announced top-line results from the Phase III APCOR-DL-BCL1 trial of epkinley monotherapy. The results showed an improvement in progression-free survival, as well as improvements in complete response rates, duration of response, and time to next treatments. And in fact, this is the first phase 3 study to demonstrate an improvement in progression-free survival in patients with relapsed or refractory diffuse large B-cell lymphoma who are treated with a CD3-CD20 T-cell engaging bispecific monotherapy. Overall survival did not reach statistical significance, and further analysis of the data is ongoing. including the potential impact of a variety of factors, including COVID-19, and the increasing availability of novel antilymphoma therapies. The full trial results will be submitted for presentation at a future medical meeting, and we will engage with global regulatory authorities on next steps. The monotherapy results do not change our expectations for our other Phase III trials. And we are very confident that these studies continue to have the potential to move Epkinley earlier in the treatment paradigm and significantly increase its addressable population from approximately 27,000 patients today to almost 150,000 patients by early in the next decade. The data presented across Epkinley, ReNA-S, and Petrocentumab in 2025 strengthened our conviction in these programs. Now in 2026, It is the meaningful registrational readouts that will be the catalyst that allow us to potentially bring these antibodies to patients in 2027. I'm pleased to now hand you over to Brad for a review of the recent commercial performance for Upkinley and Tiftec.

Thanks, Jan. 2025 marked another successful year for our commercialization team. We maintained leading positions for our proprietary brands globally. and we made important progress evolving into a wholly-owned model, fueling our long-term growth engine. In the past year, we successfully executed four key launches across our portfolio, two of which were led entirely by GenMab, demonstrating the strength of the commercialization model we've built in the US, Japan, and now in Europe. We expanded our footprint to three additional markets, opening business operations in Germany, the UK, and France, and we delivered on our commitment to bring in our antibody-based medicines to patients in area of high need. To this end, CYPDAC became the first ADC-approved in recurrent or metastatic cervical cancer in the EU, UK, and Japan, providing a much needed option for patients whose disease progresses after initial therapy and where outcomes have historically been poor. Additionally, With its approval in the U.S. and relapsed refractory follicular lymphoma, Epkinley became the first bispecific antibody approved in any form of non-Hodgkin's lymphoma in the second-line setting, and the first bispecific combination therapy approved in the lymphoma space. These milestones represent progress for patients, and they set the foundation for our growth trajectory in gynecologic cancers, along with RENAS in the future, and further into B-cell malignancies. Through our efforts in 2025, sales of our proprietary medicines totaled $632 million. This is up 54% year-over-year and accounting for approximately 28% of our total revenue growth. We expect this growth trajectory to continue in 2026, grounded in the strong foundation we've built as we deliver our own medicines to an increasing number of patients around the world. Now let's take a closer look at Epkinley. We closed out 2025 with solid performance, achieving $468 million in sales for the year, which represents a 67% year-over-year increase. This performance was driven by continued growth for the brand across geographies as the first and only bispecific with approved dual indication in diffuse large B cell lymphoma and FL in Europe, Japan, and the US. In fact, Epkinley closed 2025 with regulatory approvals in more than 65 countries, nearly all of which feature the dual indication. We continue to be encouraged by Epkinley's strong momentum and the positive feedback we hear from physicians across geographies regarding Epkinley's differentiated clinical profile, powerful efficacy, and proven safety, and the value of having a single dual indication option across DLBCL and FL. In the U.S., this momentum's translated to continued growth for Epkinley across sites of care, with an acceleration in new sites ordering, including in the community, and the majority of health systems now ordering from multiple sites. As expected, following the launch of Epkinley and Second Line FL in November, we're seeing increased uptake, suggesting that this approval will be a growth driver for the brand. In Japan, we continue to see Epkinley's launch in third line plus FL build on the brand success and large B cell lymphoma. This is driven in large part by Epkinley's dual indication differentiation and execution by our field teams to activate sites. Across all other markets, we continue to increase our presence through our partner AbbVie and its global footprint. We closed out the year with yet another quarter of solid cells for Epkinley in these markets as we continue to see rapid uptake in countries gaining access and reimbursement. Looking ahead, 2026 will be a pivotal year for Epkinley as we advance our position in early lines of therapy and anticipate key data readouts supporting Epkinley's versatility and status as the core therapy in B-cell malignancies. Our focus is on delivering Epkinley to as many patients as possible, particularly in early lines of therapy where we see the market opportunity and critically, where we may have the opportunity to truly transform the trajectory of these diseases for patients. To that end, we're maximizing our first mover advantage in second-line FL in the U.S., and we expect to build on this opportunity across markets with anticipated approvals in this setting in Europe and Japan later this year. With this traction in earlier lines of FL, we're looking towards key readouts in 2026 in first- and second-line DLBCL with fixed duration, Epkinley combination therapies to further strengthen Epkinley's position in DLBCO. Together with robust development program for Epkinley and strong execution by our teams, we see a clear opportunity for Epkinley to achieve blockbuster status over the next few years. Moving now to TIVDAC. TIVDAC continues to be recognized as the global standard of care in recurrent or metastatic cervical cancer. In 2025, TifTac generated $164 million in sales, representing a 26% year-over-year increase. TifTac continues to perform well across both new and established markets, highlighting the clear need for treatments that improve survival for women with advanced cervical cancer across geographies. In the U.S., notably, TifTac posted its fourth consecutive year-over-year growth, underscoring its continued market leadership. This strong, stable performance continues to be driven by the depth and breadth of sites of care using TIBDAC. In Japan, TIBDAC demonstrated another strong quarter of continued performance, underscoring the traction it's gaining in the second-line setting and the high patient need in recurrent and metastatic cervical cancer in the country. This trend continued in Europe, where the launch in Germany continues to be off to an encouraging start with strong, consistent uptake and positive physician feedback. As the first medicine we've launched in Europe independently, our efforts in recent months have demonstrated our ability to strategically build infrastructure and scale in new markets. We received MHRA approval in December in the UK and are now working towards reimbursement to bring TIVDAC to more patients as soon as possible. As we look ahead to the new fiscal year, we have the foundation in place to continue this momentum and bring TIVDAC to additional markets. Infrastructure and operations are well underway in new markets, with our teams executing in preparation for exciting launches on the horizon. We expect to see continued positive performance across markets as we strengthen and scale our presence and broaden our impact within the gynecologic cancer community. Wrapping up, 2025 was a critical year in our company's evolution. We built on our proven launch expertise and scientific strength, and achieve key milestones to solidify our commercialization model and business operations that will unlock our ability to deliver on the significant growth opportunities ahead of us. Our proven ability to evolve our model in the U.S. and Japan, coupled with the early traction we are seeing in Europe, gives us the confidence that we have the pieces in place today to drive future growth and expansion. With this strong foundation, 2026 is shaping up to be another meaningful year for GenMap. We will grow the impact of our proprietary portfolio, expand our footprint, and sharpen our capabilities as we look toward entering new and larger market opportunities and delivering on the blockbuster potential of McKinley, Rena S., and Peter Simpson Mav in the coming years. With that, I'll hand the call over to Anthony to discuss our financials.