Genmab A/S

Good day and thank you for standing by. Welcome to the GENMAP full year 2023 financial results conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question and answer session. To ask a question during the session, you need to press star 11 on your telephone keypad. You will then hear an automated message advising your hand is raised. To withdraw a question, please press star 11 again. Please be advised that this conference is being recorded. This presentation contains forward-looking statements. The words belief, expect, anticipate, intent and plan and similar expressions identify forward-looking statements. All statements other than statements of historical facts included in this presentation, including without limitation those regarding our financial position, business strategy, plans and objectives of management for future operations, including development plans and objectives relating to our products. are forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause our actual results, performance, or achievements to be materially different from any future results. Performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding our present and future business strategies and the environment in which we will operate in the future. The important factors that could cause our actual results, performance or achievements to differ materially from those in the forward-looking statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of our products in patients, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and the markets, our inability to attract and retain dutifully qualified personnel, The unenforceability or lack of protection of our patents or proprietary rights. Our relationships with affiliated entities, changes and developments in technology which may render our products obsolete and other factors. Further, certain forward-looking statements are based upon assumptions of future events which may not prove to be accurate. The forward-looking statements in this document speak only at the date of this presentation. GENMAP does not undertake any obligation to update or revise forward-looking statements in this presentation, nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. At this moment, I would 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 the company's financial results for the period ending December 31st, 2023. With me today to present these results is our CFO Anthony Pagano and our Chief Operating Officer Anthony Mancini. For the Q&A we will be joined by our Chief Medical Officer Tahir Mahdi. Let's move to slide two. As I already said, We will be making forward-looking statements, so please keep that in mind as we go through this call. Let's move to slide three. During today's presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships. Let's move to slide four. JanMab has continued to have transformative growth in all areas of our company. This has been possible because of what makes us unique. We firmly believe in the natural ability of the immune system to fight against disease and we use our deep understanding of disease mechanisms, targets, and antibody biology to invent proprietary technologies. This in-house expertise is matched with strategic partnerships that help us to take our products farther than we could on our own and they give us access to high quality and unique disease targets and additional cutting edge technologies that can be combined with ours. So we leverage the combination of cutting edge scientific capabilities or expertise in translational and precision medicine, data science and AI, as well as strategic partnerships to create a robust pipeline of potentially first in class and best in class products. The success of this model can be seen in the events of 2023, So let's review these now. Slide 5. 2023 was a truly remarkable year with multiple regulatory approvals for Apcoritumab. And as a reminder, GenMob is the commercial lead for Apkinly in both the US and Japan. We are pleased at how the launch is progressing so far, but the current approvals are only the first step to potentially establishing abcorritumab as the core therapy across the Fus-Las-Visa lymphoma, follicular lymphoma and beyond. In June, we announced positive top-line results for the follicular lymphoma cohort of the Phase I-II-Abcor NHL-1 trial. This data, along with preliminary dose optimization, was presented during the ASH conference in December. It also supported two exciting regulatory actions that we announced in November, that the FDA had granted breakthrough therapy designation to abcaritumab for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, and that the EMA had validated the type two variation application for abcaritumab for the same indication. Together with EPFI, we are advancing a robust clinical development program for abcaritumab across B-cell malignancies. In addition to the data in follicular lymphoma, you can also see this in the multiple phase three studies that we anticipate will be initiated in 2024. Let's move to slide six. Abcaritumab is just one example of our maturing pipeline. We also saw progress with TIVDAC last year. As we noted in January, the FDA has accepted an SBLA seeking to convert the accelerated approval of TIFDAC in recurrent or metastatic cervical cancer into a full approval. The EMA has also accepted an MAA for TIFDAC in this indication. Both of these regulatory submissions were supported by the positive results from the confirmatory innovative 301 study in cervical cancer. and we look forward to the potential availability of TIFTAC to patients in need outside the US. In 2023, we also saw positive data from the innovative 207 study for tisotamab-fidotin in head and neck cancer. And we are pleased with our plans to actively engage with health authorities on the next steps in this indication as well, along with our partner CISA, which is now part of FISO. Another program that has cleared a very high bar for continued investment in development is Acacunlimab or GEN1046, which we are co-developing with BioNTech. We were very pleased to announce in November that we have planned engagement with health authorities on the design of the physical trial for Acacunlimab in second line non-small cell lung cancer. and that we continue to plan to share the data on which this decision was based at a medical conference in the first half of 2024. In addition to maturing this program, we are also expanding it with a phase two trial in endometrial cancer, which is currently recruiting. Moving to progress, we saw with other pipeline programs, as we also noted in November, we remain very encouraged by the clinical efficacy data we are seeing with GEN1042. and we are anticipating that we will have the data we need to determine next steps for this program this year. Looking at some of our earlier stage programs, the Phase 1-2 trial of GEN1047 or dual-body CD3B7H4 is currently in the dose expansion phase, an important step in progressing our CD3-based bispecific platform in solid tumors. and GEN3017 or dual-body CD30 started recruitment for a first in human clinical trial. Finally, we had two IND submissions near the end of last year, GEN1059 or dual-body APCOM-41BB which just saw its first patient in a phase one trial and GEN1055 or hexabody OX40. Both of these antibodies are being co-developed with BioNTech. The success of the GENMAP model is also apparent in our move into the therapeutic area of INI with our partnership with Algenics. With our deep scientific knowledge of antibody biology and antibody technology, an expansion into this therapeutic area was a logical next step. And with eight approved medicines on the market, that are based on our cutting-edge innovations, we will continue to have growing recurring revenue streams that we can strategically invest in our company. Finally, Anthony Pagano, our CFO, will outline our capital allocation strategy, focused on fueling growth and enhancing shareholder value. We are investing in our mid- to late-stage pipeline and pursuing growth through targeted business development and acquisitions. After prioritizing these areas, we will consider returning capital to shareholders. And here we plan to seek authorization for a 3.5 billion kroner buyback at our upcoming ATM. I'm pleased to now turn the call over to Anthony Mancini to take you through our 2023 NAP product sales. Anthony, the floor is yours.

Thanks Jan. I'll review our Q4 and full year 2023 product revenue performance on slide seven. Our business is comprised of two key revenue streams, royalty medicines, shown here, and in-market or launch medicines, which we commercialize ourselves with partners. Our portfolio includes six main royalty medicines, Darzalex, Cosimta, Tepeza, Tecvile, Ribervant, and Talve. Darzalex showed continued strong demand growth in Q4, with over $2.5 billion in net sales. at 22% year-over-year growth, and the full-year result was over $9.74 billion driven by volume growth, also a 22% year-on-year growth. Over 450,000 patients have been treated with Darzalex around the world. We're encouraged by the continued market share gains in the first-line setting. The J&J focus in this setting is anchored by compelling long-term MyaOS data, which is helping establish Darzalex as a foundation to overall survival in the first-line multiple myeloma space. With the recent filing of Perseus, there are continued growth opportunities ahead with Darzalex sub-Q-based therapies in the frontline transplant-eligible multiple myeloma space, including maintenance. Darzalex is also being combined with both newer and older therapies in myeloma, like two of our recently approved dual body medicines, Tefile and Talve. We expect continued growth and usage of Darzalex as a backbone in later line settings as well. Kesimpta achieved continued strong demand growth with 640 million in the quarter and 2.2 billion for the full year 2023. Kesimpta demand growth is not only progressing well in the United States, but also ex-US. It is now the NBRX share leader in seven of 10 major markets outside the US. Over 85,000 patients have now been treated since the launch in August 2020. On our other royalty medicines, with the acquisition of Horizon by Amgen, Tepeza, the first and only FDA-approved treatment for thyroid eye disease, continued to grow in the quarter. Tepeza was also approved in Brazil and was submitted for regulatory review in Japan in Q4. European filings are planned in 2024. Tecvali and Talde, two bispecific T-cell engagers based on our dual-body technology, both in launch mode, continue to perform well in relapsed to refractory multiple myeloma. From Ribravent, another dual-body, data from the Phase III Mariposa and Phase III Mariposa II studies have been filed in Q4 in the first line treatment of patients with locally advanced or metastatic EGFR mutation positive non-small cell lung cancer, as well as in patients with EGFR mutated non-small cell lung cancer who failed prior therapy. There have been three submissions based on Phase III data from the Ribovent Clinical Development Program in the last four months of 2023. We expect to see continued strong GenMab revenue growth from our diverse Royalty Medicines portfolio in 2024. Turning to our in-market performance on slide eight, Epp Kinley delivered 36 million in net sales in Q4 and 64 million for the full year 2023, of which 55 million is from the U.S. market. were very pleased with Epkinley's early launch demand performance across geographies. In the US, we continue to see robust uptake across key accounts. In Japan, Epkinley was launched in late November after receiving a national health insurance price listing. We're also highly encouraged by the early launch momentum and overall positive response received from our customers in Japan. We've continued to effectively leverage are first to market advantage in the CD3, CD20 class in both the U.S. and Japan. Epkinley's clinically differentiated profile is making a meaningful impact in our first indication, third line plus diffuse large B-cell lymphoma in an area of very high unmet medical need. Our third line plus DLBCL indication is the first step to establishing Epkinley as the core therapy across B-cell malignancies like follicular lymphoma and in earlier lines of treatment. Turning to TIVDAC, TIVDAC delivered 25 million in net sales in Q4 and 90 million for the full year 2023. This represents the ninth consecutive quarter of demand growth. We are pleased with TIVDAC's performance and growth, primarily driven by an increasing breadth of ordering accounts. and MedOnc customers continue to provide positive feedback on the impact TIBDAC is making on the lives of women with cervical cancer. On January 9th, along with Pfizer, we announced the FDA-granted priority review for the SPLA for TIBDAC based on Innovative 301, which showed meaningful OS data with an FDA PDUFA action date of May 9th. The customer reaction to Innovative 301 has been very positive with most stating that this data establishes TIBDAC as a clear standard of care in second-line-class recurrent metastatic cervical cancer. As an end-to-end biotech, we're very pleased with our in-market medicines performance and look forward to carrying this momentum into 2024. We anticipate that our in-market medicines at Kinley and TIBDAC will contribute just under 40% of GMAT's total revenue growth in 2024. I want to take this opportunity to thank our partners, and I want to thank the GenMab team across commercialization, research and development, and enabling functions for all they do every day to deliver our commitment to the patients we serve. With that, let me hand it off to Anthony Pagano to provide more perspective on our total company performance and our guidance for 2024. Anthony?