Genmab A/S

Hello and welcome to GenMAP's Financial Results Conference Call for the first time in months of 2024. 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. GenMab 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 GenMab may hold your personal data as indicated by you as part of our investor relations outreach activities. In order to update you on GenMab going forward, please refer to our website for more information on GenMab and our privacy policy. I would now like to hand the conference over to your first speaker today, Jan van de Winkel, please go ahead.

Hello and welcome to GENMOB's conference call to discuss the company's financial results for the period ending September 30, 2024. With me today to present these results is our CFO, Anthony Pagano, and we will also welcome our new Chief Commercial Officer, Brad Bailey. For the Q&A, we will also be joined by our Chief Medical Officer, Tai Yamadi, and our Chief Development Officer, Judith Klimovski. Let's move to slide two. 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. This slide acknowledges those relationships. At GenMob, we have a history of consistent and exceptional success. Eight products, either created by GenMob or via our technology, are currently approved and making a difference in the lives of patients. Of all approved bispecific antibodies, a third of them were created using our dual-body technology. This success allows us to continue our focus on transforming our business in a strategic and stepwise manner, with an eye to the future and how we can best serve patients through our innovative antibody medicines. At the beginning of 2024, AppKindly was the key focus of our late-stage development. Nine months later, we now have two wholly-owned late-stage assets, Rhino-S and Akkasun Limob. Recent events showcase how we are prioritizing the development of these programs, starting with AppKindly. We believe that our validated dual-body technology has given it the best-in-class profile. We are extremely pleased with the launch, especially in Japan, where we have a significant head start over other therapies, and at present, AppKinley is the only approved CD3-CD20 base by Specific. In fact, since launch, we have consistently outperformed our closest competitors globally. In August, AppKinley received its second approval in Europe. That makes it the first and only subcutaneous bispecific antibody approved in both the European Union and the US to treat both relapsed refractory follicular lymphoma and relapsed refractory diffuse large B-cell lymphoma. This demonstrates the potential of abcaritumab to provide a convenient single treatment option across multiple B-cell malignancies. We received additional support for the potential of abkinly in September. with the FDA granting a second breakthrough therapy designation for Epkinley in relapsed refractory follicular lymphoma, this time in combination with rituximab and lenalidomide. With five phase three clinical trials ongoing and more than 20 abstracts accepted at this year's S meeting, including four oral presentations, We and our partner, APFI, remain committed to exploring the development of abcaritumab as a potential core therapy across B-cell malignancies, as demonstrated through the breadth of data presentations this year across forms of lymphoma and lines of therapy. We have also seen recent progress with Reina-S and Akasunimab, our two wholly-owned programs with the potential to be best-in-class therapies. Both of these programs have now moved toward late-stage development with the recent listing of Phase III trials on clinicaltrials.gov. We presented promising dose expansion data in ovarian cancer for Rhin-asset asthma, and we also presented PKPD data at the World Conference on Lung Cancer for Acacunimab that is supportive of our every six-week dosing schedule. We continuously evaluate our clinical pipeline to ensure we are prioritizing our resources in the best and most effective way possible. After careful consideration, we have decided to terminate the early stage clinical programs, GEN1047, GEN3017, and GEN1056. And we will no longer start phase three development for TIFDAC and Second Line Plus head and neck cancer. What should be clear is that our strategic prioritization means we are very focused on maximizing the potential of our phase three programs, APKinley, Rhynas, and Akasunlimab. The number of patients who may benefit from medicines powered by our innovation continues to expand. In September, Amgen's Depessa was approved in Japan, making it the first and only treatment for active thyroid eye disease in the country. J&J achieved multiple approvals for rival funds across the US, Europe, and Japan. And J&J have also expanded Darzalex FastPros indications with additional approvals and a regulatory submission. These developments highlight significant advancements in products that fuel our growing recurring revenues. Brad will now provide you with a review of the recent performance for AppKindly and Tiffdex, both of which have consistent quarter-over-quarter growth. Brad, the floor is yours.

Thank you, Jan. I'm delighted to be joining my first earnings call as Chief Commercial Officer. And over the past several years, we've had a clear focus on building our commercialization capabilities at GenMap. To date, we've been very pleased about a strong performance of our launches in the U.S. and Japan, powered by this strategic investment at work, and this quarter is no different. Specifically, during the third quarter, our commercialization teams executed effectively to deliver our own medicines, Epkinley and TIVDAC, to even more patients worldwide. Epkinley, which is the first and only bispecific approved for both relapsed refractory third-line plus diffuse large B-cell lymphoma and third-line plus follicular lymphoma, closed Q3 with strong performance, reporting 70% growth in the quarter, 82 million in net sales globally, and year-to-date sales of 203 million. Overall, we've continued to see robust uptake across key accounts, strong field execution, and positive responses from physicians and patients. What we're seeing in the field is validating Upkinley's differentiated profile. Most importantly, patients are benefiting from its efficacy, manageable safety, and the seamless experience of subcutaneous administration. In the U.S., Epkinley continues to assert in-class leadership through competitive differentiation and targeted activation with rapid uptake and adoption by key accounts, including a meaningful acceleration following the FL approval. We attribute this performance to three key factors. First and foremost is Epkinley's clinically differentiated profile, which addresses a high unmet need across histologies. We've heard positive feedback from physicians regarding the long-term follow-up data presented at ASCO, underscoring the durability of powerful responses with Epkinley and Thirdline Plus DLBCL. And as John mentioned, we look forward to building upon this with continued follow-up at ASH in December. Second is broad U.S. market accessibility across payers, institutional formularies, and diverse sites of care. Third is the highly effective and well-coordinated execution across our field-based commercialization teams to deliver optimal customer experiences. As we look ahead, brand execution will focus on accelerating adoption and tailoring their approach to account needs. Moving on to Japan, we continue to be pleased with Epcali's performance, with growth largely driven through strong field execution and the broadening types of accounts as activated. As we move to Q4, We will continue to focus on account openings to assure a broad range become familiar with that Kenley ahead of a potential approval in FL. In Europe and the rest of the world, through our partner AbbVie, we also saw strong growth in the third quarter. Turning to TIBDAC, TIBDAC continues to demonstrate strong performance with the 12th consecutive quarter of demand growth and $32 million in sales. The increase in demand is largely driven by the strength and breadth of accounts using TIBDAC. TIVDAC provides unprecedented efficacy where previous options have typically offered low response rates and poor outcomes, and its strong performance with solid year-over-year growth builds a strong foundation to deliver future success in the guideline space. We continue to receive positive feedback from physicians around the results from the innovative 301 confirmatory trial, which demonstrated an overall survival benefit for TIVDAC, with most stating that these data established TIVDAC as the clear standard of care in Second Line Plus recurrent or metastatic cervical cancer globally. As we move ahead, we're focused on capturing more value from our own to commercialized medicines, which represented 35% of GenMAP's overall revenue growth this year. Our foundational investments and our commercialization capabilities are fueling our success and will enable us to scale functions across the business to support our long-term growth. We're building on our momentum expect a successful year-end conclusion. With that, I'll pass it over to Anthony to provide more perspective on our third quarter financials.