Genmab A/S

Hello and welcome to the GENMAB first quarter 2024 conference call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements. They'll include words such as believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delays 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 GenMap and our privacy policy. I would now like to hand the conference over to your first speaker today, Jan van der Winkel. Please go ahead.

Hello and welcome to GenMap's conference call to discuss the company's financial results for the period ending March 31st, 2024. 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, Tai Yamadi, and Chief Development Officer, Judith Klimovski. 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. Before we look at our first quarter results, I want to remind you of our consistent track record of success. Our proprietary technologies fuel our robust product pipeline, which is both expanding and maturing. and our growing revenue streams allow us to continue to invest in our people and in our pipeline. These are investments that will further accelerate our evolution into a fully integrated biotech innovation powerhouse. In addition to our existing technologies and mid to late-stage pipeline, a key investment that will enhance our long-term growth profile is the exciting proposed acquisition of ProfoundBio. So let us turn to that briefly now. The proposed acquisition of ProfoundBio firmly aligns with our core vision and strategy of transforming the lives of people with cancer and other serious diseases. It is highly complementary to our business. And the addition of ProfoundBio's next generation ADCs, including Reina S, plus its novel ADC technology, will further strengthen our already very strong and innovative mid- to late-stage clinical pipeline. This will also strengthen and accelerate our capabilities in the ADC space, in addition to helping to propel us towards a 100% owned model with more value captured. So we are investing to unlock meaningful value by the end of the decade, with significant upside into the 2030s. We expect to close the acquisition in the first half of 2024, subject to the receipt of regulatory clearances. So now let us turn to other important recent events. Abcurritumab continues to receive regulatory approvals in relapsed or refractory diffuse large B-cell lymphoma in various territories, with additional filings underway. We and our partner, APVI, have a robust development plan for abcaritumab, and in the first quarter of the year, we took significant steps to move into follicular lymphoma. In March, we, along with APVI, initiated the first of multiple phase 3 trials anticipated to start this year. Abcaritumab in combination with trituximab and lenalidomide for the treatment of patients with previously untreated follicular lymphoma. Looking at relapsed or refractory follicular lymphoma, in addition to the JNDA submission in Japan, the FDA granted priority review to a supplemental biologic license application for Abkinley as a treatment for relapsed or refractory follicular lymphoma following at least two prior lines of therapy with a PDUFA date of June 28th. If approved, Abkinley will be the first and only subcutaneous bispecific antibody approved to treat this indication. And these were not the only regulatory events. Excitingly, the FDA has now approved the supplemental biologics license application for TIFDAC for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. And this converts the 2021 accelerated approval of TIFDAC to a full approval. making TIFDAC the first ADC with demonstrated overall survival data to be granted full approval in this patient population. This approval represents a significant achievement for women with recurrent or metastatic cervical cancer as it reinforces TIFDAC as a survival-extending treatment option in patients whose disease has advanced after initial treatments. In addition to this approval, I'm very excited to share that at the end of April, we filed a JNDA requesting approval for TIFTEC for patients with advanced or recurrent cervical cancer in Japan. And this is excellent news for patients in Japan in need of this potential therapy and a milestone for GENMOP as we continue to build our presence in Japan. I would like to thank the patients and investigators who took part in the clinical trials that formed the basis of the U.S. approval and Japanese submission, our partners at Pfizer for their collaboration, and the passionate and determined teams at GenMob whose hard work and commitment made these events possible. Before moving on, I would also like to note that we were very pleased to hear that in March, TifDec was added to the NCCN clinical practice guidelines in oncology for vaginal cancer under other recommended regimens. In the first quarter, there were several data presentations across our programs, including an oral presentation for TifDec at the SGO annual meeting on women's cancer. and presentations for at Kinley at conferences, including the annual meeting of the Japanese Society of Medical Oncology and the AACR annual meetings. We are also looking forward to multiple upcoming data presentations at ASCO, These include two rapid oral presentations for APKinley of new data in both relapsed or refractory and untreated follicular lymphoma, a rapid oral presentation on TIFDAC in head and neck cancer, and a poster presentation for acrosunlimab, or GEN1046, in second-line non-small cell lung cancer. And this is, of course, the data that we and our partner, BioNTech, anticipated presenting in the first half of this year. And we are currently engaging with health authorities on the design of a pivotal trial in this patient population with an aim to start this trial in late 2024. Finally, turning to medicines powered by our innovation, in March, Janssen announced that the FDA approved Ribofant in combination with chemotherapy for the first-line treatment of patients with non-small cell lung cancer with EGFR exon 20 insertion mutations, converting the May 2021 accelerated approval to a full approval. In addition, in Q1, Janssen submitted applications for approval in both the U.S. and Europe for subcutaneous daratumumab based on data from the Phase III Perseus study. I'm pleased to now hand over the call to Anthony Mancini to take you through our first quarter 2024 net product sales, including for Darcelex. Anthony, the floor is yours. Thank you, Jan.

In Q1, product performance across our two key revenue streams, Royalty Medicines and GenMav Commercialized Medicines, showed very strong growth. Our portfolio includes six Royalty Medicines, Darzalex, Casimta, Tepeza, Tecvile, Ribravent, and Talve. Darzalex demonstrated strong demand growth in Q1 with just under $2.7 billion U.S. dollars in net sales, a 19% year-over-year growth driven predominantly from share gains in frontline multiple myeloma. With the recent filing of Perseus, there are continued growth opportunities ahead with Darzalex subcutaneous-based therapies in the frontline transplant-eligible multiple myeloma space, including maintenance. Darzalex is also being combined with both newer and older therapies in multiple myeloma, including with two of our recently approved dual body medicines, Tecvile and Talve. We expect continued growth and use of Darzalex as a backbone in later line settings as well. Kesimpta achieved continued strong demand growth with $637 million in Q1, a 66% year-on-year growth. Casinta demand growth is not only progressing well in the United States, but also outside the United States. It continues to be the new-to-brand share leader in 7 of 10 major markets outside the U.S. The performance across our other recently launched royalty medicines, Tecfili, Talve, and Ribervent, all bispecifics based on our dual-body technology, each delivered strong growth in the quarter. The Tecfiley launch is continuing to go very well and delivered 133 million in the quarter with strong uptake and rapid adoption in the U.S. and other key markets, reflecting a best-in-class, off-the-shelf BCMA bispecific therapy that's offering deep and durable responses in relapsed or refractory multiple myeloma. We expect to see continued strong GENMAB revenue growth from our diverse royalty medicines portfolio in 2024 and beyond. Turning to our GENMAB commercialized medicines on slide eight, Epkinley delivered $54 million in net sales for Q1, with over 90% coming from strong launch performance in both the U.S. and Japan. We are very pleased with the Epkinley launch performance across geographies. In the U.S., we continue to see robust uptake across key accounts. Epkinley was launched in Japan late last year and we're highly encouraged by the early launch uptake and overall positive response from our customers there. Epkinley is the first and only approved bispecific antibody in the U.S., the EU, and Japan for patients with third-line plus diffuse large B-cell lymphoma. And we are preparing for potential approvals for Epkinley in third-line plus follicular lymphoma with U.S. PDUFA date of June 28th. We're also pleased to announce that earlier this week, the NCCN has included epkinley monotherapy as a preferred regimen with a 2A designation in follicular lymphoma after two prior lines of therapy. Our first indication in third-line plus DLBCL, an area of significant unmet need, is the first step to establishing epkinley as the core therapy across B-cell malignancies, including follicular lymphoma. and in earlier lines of treatment. TIBDAC delivered $27 million in net sales for Q1, representing the 10th consecutive quarter of demand growth. We're pleased with TIBDAC's performance, which was primarily driven by an increasing breadth of ordering accounts. Gynonc and Medonc customers continue to provide positive feedback on the impact TIDDAC is making on the lives of women with cervical cancer. As Jan mentioned, the Japan New Drug Application for TIDDAC was submitted in late April. And the FDA approval on April 29th, based on the innovative 301 study, which demonstrated a 30% improvement in overall survival and a 33% improvement in progression-free survival, will help establish TIBDAC as the clear standard of care in second-line plus recurrent or metastatic cervical cancer. We're enthusiastic about the proposed acquisition of ProfoundBio, whose lead asset, RNA-S, is a potential best-in-class ADC in ovarian cancer that would add a second ADC in gynecologic oncology to our portfolio in addition to TIBDAC. As an end-to-end biotech company, We're very pleased with the performance of our GenMav commercialized medicines and look forward to carrying this momentum through 2024 and beyond. Thanks to our partners and thanks to the entire cross-functional GenMav team for all they do every day to deliver for the patients we serve. With that, let me hand it off to Anthony Pagano to provide additional perspective on our Q1 financials. Anthony?