Genmab A/S

Hello and welcome to the GENMAB 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 believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. GENMAB is not under any obligation to update statements regarding the future nor to confirm such statements in relation to the actual results unless this is required by law. Please note that GENNAB may hold your personal data as indicated by you as part of our investor relations outreach activities in order to update you on GENNAB going forward. Please refer to our website for more information on GenMap and our privacy policy. I would now like to turn the conference over to your first speaker today, Jan van de Winkel. Please go ahead.

Hello, and welcome to our financial results for the first half of 2025. With me today is our Chief Financial Officer, Anthony Pagano, our Chief Commercial Officer, Brad Bailey, and our Chief Medical Officer, Tai Yamadi. And for the Q&A, we will be joined by our Chief Development Officer, Judith Klimowski. As we have already said, we will be making forward-looking statements, so please keep that in mind during the call. During today's presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships. I would like to start with a reminder of our commitments for 2025. In February, 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, supporting our continued growth and long-term value creation. Let's review how we have delivered on these commitments in the first half. Over the past six months, our total revenue grew by 19%, fueled by increased recurring revenue. And we have invested fully in line with our capital allocation priority, focusing on our high impact programs. More on that in a moment. Importantly, we have grown operating profit by 56%, even while making these strategic investments. In addition, in June, we completed share buyback, underscoring both our confidence in GenMob's future and our commitment to delivering value to our shareholders. We ended the first half with around $3 billion in cash. And that not only reinforces the strength of our financial foundation, But importantly, it gives us the flexibility for continued growth and expansion. Now let's turn to some of the recent advancements for our late-stage programs, as well as a reminder of the overall potential. AppGorita MOP, RENA-S, and Akasuni MOP are all poised to drive significant revenue growth for GenMOP by the end of this decade. And all three programs made progress towards this potential over the past few months. Excitingly, for Abkinley in May, we submitted an SBLA to the FDA for abcaritumab in second-line follicular lymphoma in combination with rituximab and lenalidomide, or R-square, based on a statistical and clinically significant improvement in overall response rates. In July, the FDA accepted this BLA for priority review with a target action date of November 30, 2025. If approved, abcaritumab plus R-square has the potential to be the first bispecific antibody combination regimen available as a second line treatment option for patients with relapsed or refractory follicular lymphoma. Even more excitingly, today we announced that the EPCORF-FL1 study met its dual endpoints of progression-free survival and overall response rate in a pre-planned interim analysis. These unprecedented positive results will be the basis for global regulatory submissions. And Thay will share some of the details of this promising data with you in just a moment. These important Phase III results support our goal to move Epkinley into earlier lines of therapy in order to benefit more cancer patients. Also supporting this goal, in recent months, we and EPFI have presented data highlighting the depth, breadth, and strength of the comprehensive epiretinal development program. This includes 14 abstracts at EHA, including two oral presentations, and 28 abstracts, including one oral, at ICML. So, Abkinly, with its rapid clinical development and over 40 active clinical trials, remains positioned to become the core therapy in B-cell lymphomas, with anticipated peak sales exceeding $3 billion. Turning to RINA-S. The first disclosure for single-agent RINA-S in patients with advanced endometrial cancer from a dose expansion cohort of the Phase I-II Rainfall-01 study was unveiled at ASCO. Today, Thay will provide a brief reminder of this exciting data. During our post-ASCO event, we also announced our plans to broaden the reach of RINA-S. and we anticipate that we will have three phase three trials underway by the end of the year. In addition to our ongoing trial in platinum-resistant ovarian cancer, we plan to initiate a phase three in endometrial cancer and a phase three trial in platinum-sensitive ovarian cancer. Beyond gynecologic cancers, we also announced our intent to begin a phase two trial in non-small cell lung cancer. So, you can see our track record of being able to accelerate the clinical development of key programs continues. Based on this exceptionally strong execution, we remain on track to bring RENA-S to ovarian cancer patients in 2027. And given its best-in-class profile, we expect to achieve peak sales in ovarian and endometrial cancers exceeding $2 billion. We're also launching a phase two study for akasundimab as we evaluate its potential in advanced melanoma. And we continue to look forward to additional data for this program in non-small cell lung cancer in the second half of the year. Now over to Thay, who will provide a brief review of our recent company announcement on EPCOR-RITMOP, followed by an overview of the promising RINA-S data from ESCO. Thay, the floor is yours.

Thank you, Jan. We are, of course, extremely pleased to announce today the results of the Phase 3 EPCOR-FL1 trial, which met its dual primary endpoints of overall response rate and progression-free survival. demonstrating statistically significant and remarkably clinical data and differences in both endpoints, reducing the risk of disease progression or death by 79%, in other words, a hazard ratio of 0.21. These results, which were derived from a pre-planned interim analysis, will be submitted for presentation at this year's ASH meeting, and they will serve as the basis for global regulatory submissions. Now here, I would like to note that the supplemental BLA submission that Jan mentioned earlier with the FDA was actually based on data from an earlier interim analysis in the beginning of this year. These results also demonstrated comparable consistent statistically significant improvements in OR and PFS and the details you can see on this slide. For both interim analysis, the safety profile of epcaridomab in combination with R-squared was consistent with the known safety profile of the individual regimens, and no new safety signals have been observed. Patients with relapse and refractory follicular lymphoma do have therapeutic options available. However, responses become progressively shorter and less doable with each subsequent line of therapy, and this is accompanied by an increased risk of transformation into aggressive large-cell lymphoma. What the data we shared today for Epruridamab highlights is the potential to completely transform and disrupt this current treatment paradigm. And this is really also reflected in the collaboration with the FDA as we were able to accelerate the submission in the United States. Both the recent SBRA submission and these data, which will support the planned global regulatory submissions, as mentioned, bring us closer to being able to offer Epkini to patients in need of innovative therapies earlier in their treatment journey where they can have a much larger impact. Now let's move on to the recent VENA-S data that was shared at ASCO. Previously, we discussed the medical need for patients with ovarian cancer. There's also continued to be a significant unmet medical need for the treatment of women with endometrial cancer. At ASCO, we presented the first results for single agent VENA-S in women with advanced endometrial cancer from the dose expansion cohort B2 of the ongoing Phase 1-2 Rainfall-01 study. This cohort includes 64 patients with heavily pretreated endometrial cancer who were randomized one-to-one to receive either renal S at 100 mg per meter squared or renal S at 120 mg per meter squared. In the efficacy value of patients, the confirmed ORR was 50%, including two complete responses with RINA-S 100 milligram per meter square, and the disease control rate at that dose was 100%. Antitumor activity was observed regardless of exploratory folate receptor alpha expression levels. In addition to a superior response rate, treatment with vena S at 100 milligram per meter square led to deeper, more meaningful tumor size reductions. At the time of the data cutoff for the presentation, the median duration of response was not yet reached. And with a median follow-up of 7.7 months, eight of the 11 confirmed responses were still ongoing. And shown in the swimmer plot, Responses with RINA-S were observed early with a median time to response of six weeks for both groups, that is de facto at the first response assessment. RINA-S also had a manageable safety profile consistent with previous reports. And the safety profile was broadly similar between the two dose levels. The most common treatment emerging AEs were cytopenias and grade one and two gastrointestinal events. Notably, there were no signals of ocular toxicity, interstitial lung disease, or neuropathy observed in these reported patient cohorts. And the data we've now seen in both ovarian and especially in the meteor cancer, which is known to actually have a much lower expression of folate receptor alpha, support the important hypothesis that vena S potentially works irrespective of the level of folate receptor alpha expression. And as folate receptor alpha is expressed across a broad range of solid tumors, this, of course, presents an opportunity to broaden the potential across a diverse array of tumor types, opening multiple avenues for therapeutic expansion. So our ambition is to expand both within gynecological cancers across lines and move vena S into the early lines as fast and efficient as possible, but also beyond targeting additional solid tumors such as, in the first step, non-small cell lung cancer. To that end, a proof-of-concept phase two study is indeed planned to start dosing patients in the fourth quarter of this year. And as Jan mentioned, we are accelerating expanding the development of vena S into additional trials, which already announced three phase threes to dose their first patient in 2025, one of them already well ongoing. And now I hand it over to Brad for a review of the solid recent commercial performance for AppKinley and TIFDAG.