Genmab A/S

Hello and welcome to the GenMAP full year 2024 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 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 der Winkel. Please go ahead.

Hello and welcome to GenMob's conference call to discuss our financial results for the period ending December 31st, 2024. With me today to present these results is our CFO, Anthony Pagano, and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tai Yamadi, and 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. 2024 was marked by significant milestones towards our mission to deliver innovative medicines to patients. We made strategic investments to both accelerate the development of late-stage programs with the potential to generate meaningful revenue by the end of the decade, and to maximizing the success of our commercialized medicines. So we delivered on our capital allocation priorities in 2024, and as Anthony will describe later, we will do so again in 2025. Overall, our financial performance in 2024 was exceptionally strong, And we have further solidified our foundation for sustainable future success. Let's take a look at this in more detail. 2024 was a year of strong execution and disciplined investments, driving 31% total revenue growth, fueled by the success of our eight commercialized medicines, including Apkinly and Tifdac. Our investments were fully aligned with our strategic priorities, supporting key late-stage pipeline programs and commercial expansion, allowing us to grow operating profit by an impressive 26%, demonstrating the strength of our business. Despite significant investments, including the $1.8 billion acquisition of ProfoundBio and a $500 million share buyback, we ended the year with nearly $3 billion in cash, reinforcing our financial strength. This exceptionally strong financial position gives us the flexibility to continue investing in innovation while delivering long-term value to shareholders. Taken together, our financial results for 2024 exemplify our ability to deliver strong revenue growth while simultaneously advancing high potential programs. Now let's look forward, starting with our pipelines. We currently have 12 products or product candidates in 30 clinical trials, either ongoing or recruiting. This includes seven phase three trials between AppKinley, RhynAS, and Akkasunlimob. And based on the strong emerging data, we expect more to come. Because these three programs are poised to drive significant revenue growth for GenMob by the end of this decade. We have prioritized investments for 2025 and purposely reallocated our R&D dollars to these programs. Now let's take a deeper look at why we are confident in their significant potential. Starting with APKINDY. Together with APFI, we continue to advance an ambitious clinical development program for apcaritumab across B-cell malignancies, including frontline studies in diffuse large B-cell lymphoma and follicular lymphoma. Three of five ongoing phase three studies have been fully recruited well ahead of schedule. And in addition to confirmatory data based on accelerated enrollment, we now anticipate three potentially significant pivotal readouts by the end of 2026. Second line plus follicular lymphoma, front line diffuse large B cell lymphoma, and in second line plus diffuse large B cell lymphoma for transplant in illegible patients. If successful, this could lead to significant market expansion, especially as frontline diffuse LASB cell lymphoma represents the single largest indication. As you can see, see this on the next slide, where we summarize the significant market opportunity for APKinley. We have successfully obtained multiple regulatory approvals for APKinley, making this therapy accessible to a broader patient population. And thanks to our exceptionally strong performance in key markets like the U.S. and Japan, we are confident in our ability to expand AppKinley's reach even further. In fact, our commitment to advancing AppKinley across multiple indications in B-cell cancers underscores its potential as a best-in-class treatment with a peak sales opportunity exceeding $3 billion. Let's now turn to Reiner S., As we have shared previously, we have now initiated the first phase three trial for rhinoacin second-line plus platinum-resistant ovarian cancer. This trial is designed to address all comers, regardless of folate alpha receptor alpha expression, expanding its potential reach to a broader patient population. We intend to present meaningful follow-up data from the expansion cohort with PROC early in the first half of 2025. Additionally, we are actively generating combination data to inform next steps in platinum-sensitive ovarian cancer. Beyond development in ovarian cancer, we are also planning to present data in endometrial cancer in the first half of this year. And based on the strong signals we are seeing, we plan to start a phase 3 study in second-line plus endometrial cancer by the end of the year. All this adds up to a significant market opportunity for Reina S, which you can see on the next slide. Reina S's differentiated profile has the potential to address a broader patient population than is served by current standard of care, including low to medium folate receptor alpha expression, targeting about 85% of the platinum-resistant ovarian patient population. We are exceptionally well positioned to maximize the potential of Reina-S, given our proven clinical development capabilities, track record of acceleration, and our experience in the Gynon space with TiffDeck. Based on the exceptionally strong execution of the team post acquisition, we remain on track to bring Reina-S to patients by 2027. With its best in class profile, expected to achieve peak sales exceeding $2 billion. And with the two phase 3s we plan to have underway by year's end, we are well on track to putting in place the building blocks to achieve this target. Finally, let's take a look at the market opportunity for Akkasun Limob. In 2024, Genmob took full control of the Akkasun Limob program, providing us with a remarkable opportunity to fully own and advance this promising asset. Non-driver mutated second line non-small cell lung cancer continue to be an area of significant need. Given the worsening of performance status as patients progress through lines of therapy, physicians are interested in more tolerable, chemo-free regimens. Yet with many novel treatments failing in phase three trials, docetaxel continues to be the current standard of care. By identifying potential synergies of IO therapies, we have the potential to unlock clinical benefits that are not possible with monotherapy alone. So there is meaningful opportunity for novel treatments like acasulimab in the second line plus setting to provide not just improved response rates, but durability of response. And we are progressing a strategic development program to explore acasulimab's full potential across solid tumors. So in summary, in 2025, we will be in execution mode. We will continue to deliver on our financial commitments through focused investments in our high-priority, late-stage and commercial programs. Because it is the investment in these areas today that will position us well at the end of the decade. I will now hand over the presentation to Brad, who will provide you with a review of the recent performance for Tiffdeck and Upkinley, both of which have seen growth in 2024. Brad, the floor is yours.

Thank you, Jan. Over the course of 2024, our commercialization teams executed effectively to bring Epkinley and TIBDAC to an increasing number of patients around the world. Overall, Epkinley and TIBDAC ended the year in a strong position, demonstrating the strength of our commercialization strategy and the performance of our field teams. We also achieved critical milestones, including two new regulatory approvals in the US and continued our work to rapidly progress our development program to fuel our future growth. Through these efforts, our commercialized medicines contributed 29% of our revenue growth for the year. Moving to highlights from our commercialized portfolio, we achieved meaningful milestones with both medicines that contributed to their overall growth. Over the past three months, TVDAC and Depp Kinley have collectively received three new or updated NCCN guidelines designations. First, in December, Tyvdak monotherapy was upgraded from Category 2A to Category 1 designation for the treatment of recurrent or metastatic cervical cancer, further validating its clinical benefit for these patients. Tyvdak, in combination with pembrolizumab, was also added as a Category 2B designation for patients with PD-L1-positive disease. And earlier this month, Epkinley, in combination with Gemox, received a Category 2A designation for the treatment of diffuse large B-cell lymphoma in the relapsed refractory setting. This is especially notable as we look to bring the potential of Epkinley into earlier lines of therapy in the future. Lastly, for Epkinley at ASH, we presented a three-year long-term data from our EPCOR NHL-1 study, which evaluated Epkinley in patients with third-line or later relapsed or refractory DLBCL. These data showed that over half of patients who achieved a complete response in the trial maintained their response for more than three years with no new safety signals identified. These results represent the longest duration of CRs reported by a bispecific in this setting, further reinforcing Epkinley's clinically differentiated profile and potential to deliver deep, durable responses. Now let's turn to performance, beginning with Epkinley. Epkinley's continued to perform exceptionally well since its initial launch in 2023. It closed 2024 in a position of strength achieving $78 million in sales in the quarter and $281 million in sales for the year. This growth was driven primarily by sales in the United States and Japan. In the U.S., Epkinley remains the first and only bispecific approved with a dual indication in third-line plus DLBCL and follicular lymphoma. Throughout 2024, we continue to see sustained uptake across sites of care driven by targeted field execution and the successful FL launch in June. Since the FL launch, we have observed accelerated growth in positive physician feedback, highlighting the value of Epkinley's dual indication, its uniquely differentiated clinical profile, and seamless administration. Moving forward, we will continue to focus on accelerated adoption across broad sites of care. In Japan, Epkinley is the only approved CD3-CD20 bispecific and third-line-plus relapsed or refractory large B-cell lymphoma, and we continue to see strong, stable performance, largely driven by field execution and account activation. We are well positioned to build on this leadership position in Japan with the anticipated approval for third-line plus relapsed or refractory follicular lymphoma in early 2025. With this indication, Epikinley will become the first and only bispecific approved in Japan with a dual indication in LBCL and FL. In the rest of the world, we're seeing increased utilization of Epkinley through our partner, AbbVie, and achieved approvals in more than 50 countries worldwide by the end of 2024. We look forward to this trajectory continuing in 2025 and beyond. Looking ahead, our teams remain focused on driving adoption in priority markets while accelerating our robust development program to establish Epkinley as the core therapy in B-cell lymphomas, including in earlier lines of therapy. As we continue to target areas of high-end med need, Our commercialization teams remain focused on creating optimal customer experiences through the disciplined execution of our targeted go-to-market strategy that has consistently driven our success to date. Turning now to TIVDAC. As the only ADC with a proven survival benefit in advanced cervical cancer, TIVDAC has continued to achieve solid growth since its launch in 2021 and is regarded by physicians as the global standard of care and the clear answer in second-line plus recurrent or metastatic cervical cancer. TIVDAC produced $131 million in sales during the year, including $38 million in the fourth quarter, driven by depth and breadth of ordering accounts. With strong utilization rates in this setting, we anticipate modest growth in the U.S. in 2025. Looking ahead, we see opportunities to expand the potential of TIVDAC in advanced cervical cancer to new markets where patients' needs remain high. We expect approval in Japan early this year, where GENMAB will lead full commercialization responsibilities, and in Europe later this year following a positive CHMP opinion issued in January. Importantly, the anticipated launch in Europe provides a catalyst to enter the next phase of our commercialization strategy as we expand our work to new markets. As of January 1st, GENMAB and Pfizer have agreed to transition full commercialization responsibilities for TEPDAC in Second Line Plus recurrent or metastatic cervical cancer to GENMAB for all countries outside the U.S. and China, where Pfizer will continue to partner with GENMAB and Zylab, respectively. We're pleased with the terms of this updated agreement as it optimally positions us to expand our commercialization capabilities first to Europe in a strategic and financially disciplined manner, just as we have successfully done in the U.S. and Japan to date. We're confident that with this approach, we can optimize the launch opportunity for TIVDAC and also build a strong foundation for the potential launches of RHNA-S and aclosunumab in the future. We are extremely pleased by the performance of our commercialized brands in 2024, validating our strategic approach and investments to date. As we look toward 2025 and beyond, our focus remains on building upon the strong foundation we've established in the U.S. and Japan to capture more value from our commercialized medicines, increasing utilization of epikinley and tib-dac across regions, and strategically entering new markets to prepare for the launches of our wholly-owned medicines to reach even more patients in the future. With that, I'll hand the call to Anthony to provide more perspective on our financials.