Genmab A/S

Hello and welcome to the GENmaps financial results conference call for the first quarter of 2025. 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. GENmaps is not under any obligation to update statements regarding the future, not to confirm such statements in relation to actual results, unless this is required by law. Please also note that GENMAP may hold your personal data as indicated by you as a part of our investor relations outreach activities in order to update you on GENMAP going forward. Please refer to our website for more information on GENMAP and our privacy policy. I would now like to hand the conference over to our first speaker today, Jan van de Winkel. Please go ahead.

Hello, and welcome to GenMob's conference call to discuss our financial results for the period ending March 31st, 2025. With me today to present these results is our Chief Financial Officer, Anthony Pagano, our Chief Commercial Officer, Brad Bailey, and our Chief Medical Officer, Tai Yamadi. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimowski. As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. During today's presentation, we will reference products being developed under some of our strategic collaborations, and this slide acknowledges those relationships. In 2025, we continue to advance towards becoming a fully integrated biotech, independently developing and commercializing wholly owned antibody differentiated therapies. Our disciplined capital allocation strategy and sustained execution support our continued growth and long-term value creation. In the first quarter, we continue to deliver on our strategic priorities. Our total revenue grew by 19%, fueled by the solid performance of Upkinley and TifDoc and increased recurring revenue. Our investments remain fully in line with our capital allocation priorities, supporting key late-stage pipeline programs and maximizing the success of our commercialized medicines. And we made these important investments while growing our operating profit by 62%. In addition, in March we initiated our planned share buyback of up to 2.2 million shares. This share repurchase underscores both our confidence in Genwap's future and our commitment to delivering value to shareholders. We ended the quarter with over $3 billion in cash, reinforcing the strength of our financial foundation. And this strength gives us the flexibility for continued growth and expansion. We will continue to prioritize our investments with a laser-sharp focus on our late-stage proprietary clinical pipeline, specifically Apcaritumab, Reina-S, and Acacunlimab, and maximizing the success of our commercialized medicines. Now let's turn and focus for a moment on the overall potential of our promising late-stage pipeline, where we see multiple billion-dollar opportunities. Abcurritumab, Rhinas, and Acasulimab are all poised to drive significant revenue growth for GenMob by the end of this decade. Abkinley, with its rapid clinical development, is positioned to become the core therapy in B-cell lymphomas with anticipated peak sales exceeding $3 billion. This will be driven by three expected Phase III readouts. Two of these, including in frontline diffuse large B-cell lymphoma, are anticipated by the end of 2026. Excitingly, we recently announced our intention to submit a supplemental biologic license application to the FDA for apcoritumab in second-line follicular lymphoma. And this decision was supported by positive top-line results from the Phase III APCOR-FL1 trial. We are pleased with the strength of this initial data and we plan to submit the full results for presentation at an upcoming medical conference in 2025. Turning to Rhino-S, we are exceptionally well positioned to maximize its blockbuster potential. And I say this because we have got a powerful combination of proven clinical development capabilities, a track record of acceleration and deep expertise in the Gynon space with TIFDAQ. Based on the exceptionally strong execution of the team post-acquisition of ProfoundBio, we remain on track to bring Reina S to ovarian cancer patients in 2027. And given its best-in-class profile, we expect to achieve peak sales exceeding $2 billion. There is also a meaningful opportunity for novel treatments like acasunimab in non-driver mutations, second-line plus non-small cell lung cancer to provide both improved response rate and durability of response. So here we anticipate a peak sales opportunity of a billion dollars. And as you know, beyond these programs, we are continuing to actively look for opportunities to further grow our pipeline, both organically and inorganically. Now, let's turn to some of our first quarter advancements. APKINDY's robust clinical development and regulatory approvals reinforce its market-leading position. As I just noted, last week we announced our intent to seek approval in the U.S. for apcaritumab plus rituximab and selenalidomide in patients with relapsed or refractory follicular lymphoma, following at least one prior systemic therapy. we intend to submit this supplemental BLA in the first half of 2025. And this milestone illustrates our commitment, together with APFI, to the ongoing development of abcaritumab. In February, Abkinley became the first and only subcutaneous T-cell engaging bispecific antibody approved in Japan to treat both relapsed or refractory follicular lymphoma and relapsed or refractory large B-cell lymphomas after two or more lines of therapy. In addition, Abcurritumab in combination with GemOx was added to the NCCN guidelines for second-line patients with diffuse lymphoma who are ineligible for a transplant. TIFDAC expanded its presence with approvals in both Europe and Japan. It's now the first and only ADC approved in both territories for the treatment of recurrent or metastatic cervical cancer after prior therapy. Excitingly, the launches of TifTec in Japan and Europe will be the first time that GenMop will lead commercialization efforts on our own without a partner. This will bring us closer to achieving our goal of bringing our own medicines to patients and will strengthen our growing leadership in transforming care for patients with gynecological cancers, which also positions us for success for the potential launch of Reina S. Our potential for future success is also reflected in the multiple data presentations that either occurred recently or that we anticipate in the coming months. In March, we presented the highly anticipated updated results of Reina S in advanced ovarian cancer at the 2025 Society of Gynecologic Oncology Annual Meeting on Women's Cancer, or SGO, in Seattle. Last month, we had data from a variety of programs presented at AACR, This included preclinical data from Reiner S, as well as the early stage bispecifics Gen 1057 and Gen 1059. And we are now looking forward to ESCO, where we will have multiple presentations, including data for Reiner S in endometrial cancer. Thay will now bring you up to date with the status of this program, followed by an overview of the promising Reiner S data from SGO. Thay, the floor is yours.

Thank you, Jan, and if you could make sure that we're now on slide eight. We're confident that vena S has the potential to become a best-in-class treatment for ovarian cancer, endometrial, and other folate receptor alpha-expressing solid tumors. This confidence has led us to accelerate the development of vena S, first into a phase three trial in second-line plus platinum-resistant ovarian cancer, and also we are now on track to start a phase three study in second-line plus endometrial cancer for the end of the year. Behind this confidence is encouraging data, including the results we will present at ASCO in endometrial cancer, as well as the data that we recently presented at SGO in Prague. Now let's take a brief look at the SGO data. You could go to slide nine, please. We told you in February that we intended to present meaningful follow-up data from the expansion cohort for Prague early in the first half of 2025. and we did just that last month at SGO. The data presentation included updated efficacy and safety data with around 24 weeks of additional follow-up from the data curve of the color previously presented at ESMO last year. As a reminder, these are heavily pre-treated ovarian cancer patients. Regardless of folate receptor alpha expression, Results showed that RINA-S dosed at 120 mg per meter squared every three weeks led to a confirmed objective response rate of 55.6%. And this encouraging antitumor activity was doable. With a median on study follow-up of 48 weeks, the median duration of response was not reached as only one of the 10 patients experienced disease progression. ReNAS was well tolerated, and once again, no signs of ocular toxicity or ILD were observed. Altogether, this data reinforces the potential of ReNAS to become a best-in-class treatment for ovarian cancer, benefiting a broader patient population than currently approved therapies, with a differentiated efficacy signal across the entire patient population, that is, with no need for selection based on folate receptor alpha expression, better and differentiated safety profile, that is, without ocular toxicity or ILD, and an unprecedented durability. Now over to Brad for a review of the solid recent commercial performance for Epkindy and Tiftac.