Genmab [GMAB] Conference call transcript for 2023 q4
2024-02-14 16:17:11
Fiscal: 2023 q4
Operator: Good day, and thank you for standing by. Welcome to the Genmab Full Year 2023 Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speakers' presentation, there will be the question-and-answer session. [Operator Instructions] Please be advised that today’s conference is being recorded. This presentation contains forward-looking statements. The words believe, 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 statement includes, among other, risks associated with products discovery and development, uncertainties related to the outcome of clinical trials, slower-than-expected rate 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 suitably qualified personnel, the enforceability 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 these documents speak only as at the date of this presentation. Genmab 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.
Jan van de Winkel: Hello, and welcome to Genmab's conference call to discuss the company's financial results for the period ending December 31, 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, Tahi Ahmadi. Let's move to Slide 2. 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 3. 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 4. Genmab 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 to 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. We leverage a combination of cutting-edge scientific capabilities, our 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. Let's review these now. Slide 5. 2023 was a truly remarkable year with multiple regulatory approvals for epcoritamab. And as a reminder, Genmab is the commercial lead for EPKINLY in both the U.S. and Japan. We are pleased that how the launch is progressing so far, but the current approvals are only the first step to potentially establishing epcoritamab as the core therapy across the fuselage B-cell lymphoma, follicular lymphoma and beyond. In June, we announced positive top line results for the follicular lymphoma cohort of the Phase 1/2 Epcore 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 epcoritamab for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy and that the EMA has validated the Type II variation application for epcoritamab for the same indication. Together with AbbVie, we are advancing a robust clinical development program for epcoritamab across B-cell malignancies. In addition to the data in follicular lymphoma, you can also see this in the multiple Phase 3 studies that we anticipate will be initiated in 2024. Let's move to Slide 6. Epcoritamab is just one example of our maturing pipeline. We also saw progress with Tivdak last year. As we noted in January, the FDA has accepted an sBLA seeking to convert the accelerated approval of Tivdak in recurrent or metastatic cervical cancer and to a full approval. The EMA has also accepted an MAA for Tivdak in this indication. Both of these regulatory submissions were supported by the positive results from the confirmatory innovaTV 301 study in cervical cancer. And we look forward to the potential availability of Tivdak to patients in need outside the U.S. In 2023, we also saw positive data from the innovaTV 207 study for tisotumab vedotin 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, Seagen, which is now part of Pfizer. Another program that has cleared for very high bar for continued investment in development is Acasunlimab or GEN1046, which we are codeveloping with BioNTech. We were very pleased to announce in November that we have planned engagement with health authorities on the design of the pivotal trial for Acasunlimab 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 2 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 DuoBody-CD3B7H4 is currently in the dose expansion phase, an important step in progressing our CD3-based bispecific platform in solid tumors. And GEN3017, or DuoBody CD3xCD30, started recruitment for our first in human clinical trial. Finally, we had two IND submissions near the end of last year, GEN1059, or DuoBody-EpCAMx4-1BB, which just saw its first patient in a Phase 1 trial, and GEN1055 or HexaBody-OX40. Both of these antibodies are being codeveloped with BioNTech. The success of the Genmab model is also apparent in our move into the therapeutic area of INI with our partnership with ArgenX. With a deep scientific knowledge of antibody biology and antibody technology and 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 DKK 3.5 billion buyback at our upcoming AGM. I'm pleased to now turn the call over to Anthony Mancini to take you through our 2023 net product sales. Anthony, the floor is yours.
Anthony Mancini: Thanks, Jan. I'll review our Q4 and full-year 2023 product revenue performance on Slide 7. 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, KESIMPTA, TEPEZZA, TECVAYLI, RYBREVANT and TALVEY. DARZALEX showed continued strong demand growth in Q4 with over $2.5 billion in net sales, a 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 MAIA OS 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 subcu 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 DuoBody medicines, TECVAYLI and TALVEY. 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 U.S. It is now the NBRx share leader in 7 of 10 major markets outside the U.S. 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, TEPEZZA, the first and only FDA-approved treatment for thyroid eye disease continued to grow in the quarter. TEPEZZA was also approved in Brazil and was submitted for regulatory review in Japan in Q4. European filings are planned in 2024. TECVAYLI and TALVEY, two bispecific T-cell engagers based on our DuoBody technology, both in launch mode continue to perform well in relapsed or refractory multiple myeloma. For RYBREVANT, another DuoBody, data from the Phase 3 Mariposa and Phase 3 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 3 data from the RYBREVANT 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 8. EPKINLY 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. We're very pleased with EPKINLY's early launch demand performance across geographies. In the U.S., we continue to see robust uptake across key accounts. In Japan, EPKINLY 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 have continued to effectively leverage the first-to-market advantage in the CD3, CD20 class in both the U.S. and Japan. EPKINLY'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 EPKINLY as the core therapy across B-cell malignancies like follicular lymphoma and in earlier lines of treatment. Turning to Tivdak. Tivdak 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 Tivdak's performance and growth, primarily driven by an increasing breadth of ordering accounts. Genmab and MedOnc customers continue to provide positive feedback on the impact Tivdak is making on the lives of women with cervical cancer. On January 9, along with Pfizer, we announced the FDA granted priority review for the sBLA for Tivdak based on innovaTV301, which showed meaningful OS data with an FDA PDUFA action date of May 9. The customer reaction to innovaTV301 has been very positive, with most stating that this data establishes Tivdak as a clear standard of care in second-line plus 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 EPKINLY and Tivdak will contribute just under 40% of Genmab'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?
Anthony Pagano: Thanks, Anthony. We continue to strengthen our foundation during 2023. To start, as Jan said, together with our partner, AbbVie, we've achieved our goal of regulatory approvals and launches for EPKINLY in the U.S., Europe and Japan. And as we'll see, our financials for the year were strong. Recurring revenues grew by 22% on a reported basis. And this was principally driven by strong royalties from DARZALEX along with significant growth from the other approved medicines based on our innovations, including Tivdak and EPKINLY. Our solid balance sheet, growing recurring revenues and significant underlying profitability allow us to continue to invest in our business and our pipeline in a very focused and disciplined way. And an important part of this has been to continue to build the team and capabilities we need to succeed. So let's take a look at those revenues in a bit more detail. We grew total revenue to around DKK 16.5 billion in 2023. And as I've already highlighted, that included a 22% increase in our recurring revenue. And to be clear, that's on a reported basis. Excluding some FX headwinds, which I've described throughout the year, recurring revenues grew by 31% on an operational basis. Operational growth in 2023 continued to be strong, driven by higher DARZALEX royalties as well as royalties from other products, and this really illustrates the power of our recurring revenue. We also recognized the first quarters of net product sales for EPKINLY in Q3 and Q4. And we're really pleased with how the launch is progressing so far with around DKK 421 million in sales since launch. Of note, EPKINLY net product sales by Genmab contributed more than 20% of our overall revenue growth in 2023. Overall, our strong recurring revenue growth enables continued highly focused investment, as you can see on the next slide. A year ago, we were very clear that we would continue to invest to capture the opportunities we see in front of us, and that's exactly what we've done here with total OpEx up 33% in 2023. At that time, I outlined our top four investment priorities: First, securing a successful EPKINLY launch by investing in our two key markets, the U.S. and Japan. Second, continuing to advance our pipeline. Here, the lion's share of our investment was directed to our most advanced programs, including EPKINLY, Tivdak, 1046 and 1042. Third, investing in our world-class discovery engine. And fourth, foundational investments in enabling functions to achieve required scale. Here, it's important to note that as we exit Q4 of 2023, we believe we have reached scale in our enabling functions. So as you can see, our investments in 2023 were fully in line with these priorities. Now with that, let's take a look at our financials as a whole. Here, you can see our summary P&L for 2023. Revenue came in at around DKK 16.5 billion. That's up 14% on last year. Total expenses were about 10.9 billion with 70% being R&D and 30% SG&A. And that compares to 68% in R&D and 32% in SG&A in 2022. And even with this increased investment, we're still delivering around DKK 5.3 billion of operating profit. Moving now to our net financial items. Here, we have a gain of DKK 316 million in 2023. This is driven by an increase in interest income due to higher effective interest rates which offset the negative impact of the weakening U.S. dollar against the Danish kroner. Then we have tax expense of about 1.3 billion, which equates to an effective tax rate of 22.8%. And that brings us to our net profit of nearly DKK 4.4 billion. So as you can see, continued strong underlying financial performance. And with that, let's take a minute to revisit our robust financial framework. First off, our revenue profile on the left. With the approval of EPKINLY in May and TALVEY in August of 2023, there are now eight products on the market that are generating significant recurring revenues for us. And we expect significant cash inflows in the years to come. Moving to the right. We remain focused on our investments as we evolve our organization for continued success. At the top of the list is accelerating and expanding EPCORE with three new Phase 3 trials planned for 2024. But that's just one of the exciting opportunities that provide us with a compelling rationale for investing back in our business. As we've told you before, if we want to seize these meaningful opportunities, we've got to invest, and that's exactly what we're doing. With planned Phase 3s, not only for EPCORE, but also for Tivdak and 1046 in 2024. So with that background, let's move to our 2024 financial guidance. Before getting into the specifics, let's cover the highlights. We anticipate strong growth in revenue and operating profit for 2024 at 19% and 10% at the midpoint, respectively. For revenue, this growth will be driven by our royalty medicines and also importantly, we will have over DKK 1.2 billion of growth from EPKINLY and Tivdak. In fact, EPKINLY and Tivdak are driving nearly 40% of our total revenue growth in 2024. And note, our revenue growth of 19% will exceed our OpEx growth of 18%. On the investment side, our OpEx growth is projected to slow down significantly year-over-year. Last year, we saw a growth of 33%. And now for 2024, we're projecting 18%. And our projected DKK 2 billion increase in OpEx for 2024 at the midpoint is down from the 2.7 billion increase that we saw in 2023. So clearly, this is a significant reduction in both percentage terms and absolute Danish kroner terms. The vast majority of the increase in our investments in 2024 is directly related to mid- to late-stage R&D investments. And the increase in SG&A is muted and is primarily related to the annualization or timing impact of investments that came online in 2023 related to the launches of EPKINLY in the U.S. and Japan. And finally, the significant revenue growth and our continued focused approach to managing our investments translates to a projected double-digit or 10% growth in operating profit at the midpoint of the guidance range. So with that background, let's take a look at the components of our strong recurring revenue. For 2024, we anticipate another year of strong underlying revenue growth at 19%. Before I get into the detail, note that these projections are based on an assumed U.S. dollar Danish krone exchange rate of 6.8%. Looking at our total revenue, we're expecting to be in the range of DKK 18.7 billion to DKK 20.5 billion. A significant part of this will come from recurring revenue, where we expect around 25% growth at the midpoint. And as a reminder, our recurring revenue is comprised of our royalties and our net product sales and collaboration revenue. We anticipate that DARZALEX sales will continue to ramp up to be in the range of $10.9 billion to $11.5 billion. So we're projecting DARZALEX royalties to be between DKK 12.6 billion to DKK 13.3 billion. Most excitingly, as mentioned, nearly 40% of the revenue growth is projected to come from our two marketed products: EPKINLY and Tivdak. This really illustrates how we're crystallizing and realizing value from the important and focused investments we've made over the last several years in both R&D and commercialization. Now for our non-recurring revenue, we expect this to be 1.5 billion at the midpoint. The decrease is primarily related to lower reimbursement revenue. Note that we've included a significant sales milestone related to KESIMPTA, both in the bottom and top end of our guidance range. With that, let's take a look at our planned investments for 2024. We expect total OpEx to be between DKK 12.4 million and DKK 13.4 billion. This truly reflects the evolution of our pipeline and indeed, our entire business. We have two near-term investment priorities. First, the continued commercialization, development and expansion of EPKINLY, including initiating new Phase 3 trials that will really maximize its potential. Second is progressing the other promising programs in our pipeline, especially 1046 and Tivdak. These are our immediate priorities. But we're not just focused on today. In line with our vision, we're also very focused on long-term value creation. We're investing to maximize the value of our current technologies, and we're also investing to generate the next wave of IND candidates and to progress our early-stage pipeline. In terms of SG&A, as I highlighted a year ago and mentioned earlier today, we've been super focused on getting this number to scale. Evidence of this is that our total Q4 2023 investment in SG&A was around DKK 900 million. So you can see that off this Q4 2023 run rate, the growth here in 2024 is minor. So with that, let's break out our 2024 investment profile for you with a few numbers on the next slide. Here, we've outlined our incremental investments we're expecting to make our top priorities in 2024. Starting at the top, you can see the biggest overall increase in investment will be in advancing our portfolio. More specifically, the several Phase 3s that we’re planning for EPCORE, Tindak and 1046 that eventually may support revenue growth in the future. This is an investment for now as well as for the future as we look to expand development of our mid- to late-stage programs as well as the growth of our overall portfolio. The continued successful commercialization of EPKINLY will continue to require our focus and investment, especially in our two key markets, the U.S. and Japan. Now having a look at the framework and the constituent parts, let's look at how this all comes together. Here, you can see our 2024 guidance. We expect our revenue to be in the range of DKK 18.7 billion to DKK 20.5 billion, and that's up 19% at the midpoint. And most of this is made up of recurring revenue which is comprised of our royalties and net product sales and collaboration revenue from EPKINLY and Tivdak. And our recurring revenues is expected to account for 92% of our total revenue in 2024 compared to 88% in 2023 and 81% in 2022. And this really illustrates the improving quality of our revenue profile. For operating expenses, we expect to be in the range of DKK 12.4 billion to DKK 13.4 billion, and that's up 18% at the midpoint. As I've previously highlighted, this step-up in investment is fully in line with our strategy and our focus on creating long-term value. Putting all this together, we're planning for substantial operating profit in a range of DKK 4.6 billion to DKK 7.1 billion, with the midpoint of guidance amounting to a significant growth or significant growth in profitability at 10%. So now having covered our results for 2023 and our guidance for 2024, let me now walk you through our focused capital allocation strategy aimed at fueling growth and enhancing shareholder value. First, we will continue to invest in our proprietary pipeline and technology platforms. In particular, we're focused on investing in our mid- and late-stage programs. In addition, we need to invest to maintain our leadership in innovation and antibody tech and delivering on our promise of groundbreaking CISO medicines. Second, we're pursuing focused business development and M&A opportunities. Our objective here is clear: to accelerate our growth trajectory and broaden our portfolio. And here, we'll seek out opportunities that fit within our core focus areas. As you know, historically, we focused on external opportunities where we brought in tools and components to augment our research and discovery engine. Now, as we further built out our development and commercialization capabilities, we are well positioned to also consider development and commercial stage opportunities. This will allow us to further leverage investments we made in these areas. And finally, at our upcoming AGM, we will be asking for the authorization to launch a DKK 3.5 billion or approximately $500 million share buyback program. This underscores our confidence in Genmab's future and our commitment to delivering value to shareholders, both in the short and long term. In summary, our capital allocation strategy is straightforward. Invest in our business and in particular, our mid- to late-stage pipeline and to see growth through focused BD and acquisitions. And after these two priorities are evaluated, we can consider return of capital to our shareholders. And that's what we've done here in terms of the proposal at the upcoming AGM. Taken together, this balanced approach positions us for sustained success and long-term value creation. Now for my final slide, let me provide a few closing remarks. In summary, we had a very solid 2023. And our 2024 guidance highlights our highly compelling growth profile. We created additional growing recurring revenue streams, increasingly from our proprietary products, including Tivdak and EPKINLY. And that gives us a strong backbone of significant underlying profitability, and we're investing those revenues in a highly focused way to realize our vision and to capitalize on the very significant growth opportunities in front of us. And on that note, I'm going to hand you back over to Jan.
Jan van de Winkel: Thanks, Anthony. So let's move to Slide 21. In 2023, Genmab made great strides towards our 2030 vision, making for a transformative year in our company's history and on patient care. Our CISO antibody medicines have become a new chapter in transforming the lives of people with cancer and other serious diseases. In 2024, we will continue to work diligently towards this vision with a number of key goals for the company, starting with our currently approved medicines EPKINLY and Tivdak. And as I mentioned, we will work with our partner, AbbVie to continue to maximize the potential of epcoritamab with the initiation of new trials as well as an expanded label with the potential to move into relapsed or refractory follicular lymphoma. We will also work with our new partner, Pfizer, pending health authority feedback to advance the development of Tivdak in head and neck cancer. Turning to our clinical stage programs, along with our partner, BioNTech, we plan to progress both Acasunlimab, or GEN1046 and GEN1042. For Acasunlimab, we see the potential to initiate a Phase 3 trial in second-line non-small cell lung cancer. For GEN1042, we anticipate Phase 2 data in frontline head and neck cancer that will allow us to determine next steps for the program. So we anticipate expanding and advancing these and other clinical stage programs in our CISO product portfolio. Fundamental to the success of these programs is having the right team and culture in place. We are very well prepared to continue to scale our company based on our planned portfolio development and business needs. We will be maintaining and enhancing the science-driven, patient-focused courageous and inspirational Genmab culture and doing so with integrity. Finally, we will continue to leverage our solid financial base to support our growth, including to grow and broaden our exciting product and technology portfolio. We will look at both our existing strategy and new opportunities to do just that. We have much to look forward to in 2024. That ends our presentation to Genmab's financial results for 2023. So operator, please open the call for questions.
Operator: [Operator Instructions] And now we're going to take our first question, and it comes from line of James Gordon.
James Gordon : James Gordon, JPMorgan. My question is just would be on the buyback. Just how should we read the buyback? Should we think of this as a batch of confidence that J&J opt-in on HexaBody-CD38. So this is a great time to buy the shares? Or is it a bit more opportunistic about your share price in general or that you aren't finding attractive pipeline you could buy in, but just isn't much out there at good valuations and it's inefficient to have lots of cash on the balance sheet. So how should we read the decision to do the buyback, please?
Jan van de Winkel: So James, the decision to go for the $500 million buyback is actually a sign of confidence in our capacity to further build value for shareholders. As Anthony and I explained, we first will invest in the pipeline, and we are going to robustly progress our pipeline and technology platforms this year with multiple Phase 3 trials initiated for at least three or more of our programs. Second, we really are looking very, very actively a lot of product candidates, which could actually help us to turbo-accelerate our growth trajectory and broaden the portfolio, so we actually can increase revenue much quicker in the coming years than with own products in the pipeline. And then finally, you could see that as a sign of confidence, we believe that this is the right moment to show really strong confidence in our future and the commitment to deliver value to shareholders. So it’s a sign of strength and confidence in our own ability to further build value to our shareholders. So there will be a lot of activity this year.
Operator: Now we're going to take our next question and it comes from line of Kaveri Pohlman.
Kaveri Pohlman: My question is basically on EPKINLY. Now that it has a well-established profile, any thoughts of developing it for autoimmune diseases?
Jan van de Winkel: Right now, we are focusing on B-cell cancers and we're going to dramatically expand into different cancers, not only diffuse B-cell lymphoma and follicular but we're also certainly going to press forward in CLL as well as potentially some other B-cell cancers. And we are not considering to move into autoimmune at this moment, Kaveri, but that may very well change in the future.
Operator: Now we will take our next question. And the next question comes from the line of Peter Verdult.
Peter Verdult: Just one question maybe for Tahi, just on scene setting for 1046 in the second-line non-small cell lung cancer trial. Could you just remind us how many patients and duration of follow-up you have on what you base that decision? And then just what would you consider to be the PFS and OS hurdles you would be looking to beat in that setting?
Jan van de Winkel: So I hand it over to Tahi. Tahi, you're best placed, I think, to answer this question for Peter.
Tahi Ahmadi : Well, I mean, we've decidedly never really commented on what number we actually base the decision. But trial as it is designed was enrolling 40 patients in different cohorts. On these patients we have and sort of follow-up, it’s reasonable because there will be an earlier look that what we presented at in an abstract that was submitted in the near future what we presented at the conference, and there will be a more updated look at the conference on the data also with longer follow-up. What the PFS is -- actually median PFS is a little bit problematic, if you think about all the fair trials because it is in the population partly driven by the patients who are actually not responding to therapy. So a better way to think about this is actually landmark PFS. So how many patients are actually still in remission or have not progressed and not died at, let's say, six months. I think that would be something where I would guide you to pay attention to because that tail up is also what's going to drive the next part, which is the overall survival question, I think there's plenty of data sets that hovers the curve somewhere harvest around 11 months. So we look at this since this is an IO opportunity that the strength of the data comes to the duration of the response that we’re observing in those patients where traditionally has been incredibly hard to get any response with an IO approach since they have already exhausted as an approach. And we also believe that this actually increases the profit of success in winning on these trials given the fact that the number of trials have been negative where the focus was maybe delivered too much on initiative or reduction, but not on durability of responses if that makes sense.
Operator: Now we're going to take our next question. And it comes from the line of Sachin Jain.
Sachin Jain: Just to go back on the capital allocation. I wonder if you could just clarify, Anthony, the size of the BD opportunities you're looking at, I think you phrased them as more later stage than what you've done before. So if you could just give us a sense of what stays development, commercial stage, size of assets? And then just a quick follow-up question. HexaBody-CD38 wasn't really mentioned today. Thank you for clarifying the 1046 data will be coming in 1H. Should we expect any further dose expansion data from the cohort we saw at ASH at any point, 1H pre the head-to-head 2H?
Jan van de Winkel: So Anthony Pagano on the capital allocation and then maybe, Tahi, you can give a bit more color on the head-to-head data with the HexaBody-CD38 next. Maybe, Anthony, you can start?
Anthony Pagano: Yes. Thanks, Sachin. As you highlighted and just reiterate what I said on the call, when I talked about, I think, a little bit more informally over the last year or so that we would be willing to open up the aperture in terms of what we would be thinking about for external opportunities. And this is fully in line with if you think about the concept of natural ownership, where you a good evaluator and then good owners. And over the last couple of years, we've invested quite a bit to build out our mid- to late-stage development capabilities as well as our commercialization capability. So we're looking to leverage those investments as we move forward. And here, we're therefore, pursuing potential BD and M&A opportunities that align with our core focus areas. And of course, as you would expect, Sachin, any external opportunities will be carefully evaluated. And only if they clear the high bar that we set for ourselves, both internally but also for these external opportunities, so if they clear this high bar will be moved forward. We're going to take that same focused and disciplined approach that we've utilized in evaluating our organic investments as well as that the same approach we've taken, making the discovery-oriented inorganic investments that we've made here historically. And any external opportunities and be carefully selected again, this is really important to align with our core focus areas and to complement our existing portfolio, bring in novel antibody technologies or expand our presence in some key therapeutic areas. Further, any focused BD and M&A for clinical or commercial stage programs is really going to an important point to allow us to leverage the investments we've made and the capabilities we've built out in these key areas over the last number of years. Particularly on your question, Sachin, in terms of deal size, I'm not going to provide any guardrails out there right now. But again, as you would expect, the starting point will be to ensure that any external opportunity fully aligns with our strategic objectives and our core focus areas and most importantly, right, that it offers a clear path to creating value for our shareholders. So hopefully, that gives you a little bit more color. But at this point, we're not going to put out any specific guardrail.
Jan van de Winkel: And to add to that, Anthony, these molecules will need to be best-in-class or first-in-class at the minimum, Sachin. So we are going to be very, very critical there, and we have firepower and we have the ability to execute and leverage on the investments we made over the last few years. Let's move to Tahi now and maybe ask Tahi to give some further color on the HexaBody-CD38 data this year.
Tahi Ahmadi: I will try my best. I mean I think there is not much to add to the commentary that we've made over the last couple of once essentially, in that the head-to-head is ongoing, is on track in the timeline. We are actively and very successfully enrolling these patients. And we are on track to have all patients enrolled and then with a sufficient follow-up and to then have that discussion with Janssen once we have that follow-up. And it's important on the sell forward as important as getting the patients in because it will, in the end, be a decision made on, I suspect, response rate, but also depth of response percentage of patients who achieved VGPR better. And of course, also under the assumption that the safety profile is not materially different from DARZALEX given the fact that the success of DARZALEX to a large degree is also depending on the relative ease of combination. So that's what we are generating right now. And when we have the data, we'll have the conversation with our colleagues at Janssen and eventually also present that data to the public and the plan is on track.
Sachin Jain: Tahi, apologies the question was whether we would get any further dose expansion data relative to what we saw at ASH?
Tahi Ahmadi: No, no. We went straight into the head to head because that’s really irrelevant. So the next data update that you will get is the actual head to head, which I think will be most informative for our parties involved including you.
Operator: And then the next question comes from the line of Jonathan Chang.
Jonathan Chang: On the 2024 net product sales and expense guidance, are you able to provide any more color around how those break down by program? And maybe just adding on that on the early Epcoritamab launch, how has that impacted your thinking on the CD20 by CD3 competitive landscape and your ability to be the market leader in this space?
Jan van de Winkel: So the first one, and I think be handled by Anthony Pagano. And the second one, certainly, Anthony Mancini can give you a bit more color there because we're very optimistic about EPKINLY. Anthony Pagano, maybe you can start?
Anthony Pagano: Thanks, Jonathan. I think in my prepared remarks, I gave quite a bit of detail in terms of breaking down both the overall composition of our revenue. As you can see, we kind of took it to a different level in terms of breaking out the net product sales and the collaboration revenue gave kind of very explicit guidance there, combining EPKINLY and Tivdak can give you a good sense of the overall trajectory. We're not going to provide specific guidance for EPKINLY or Tivdak at this stage. You would also have noted Jonathan, I did highlight in terms of the non-recurring revenue, the step-down being driven by reimbursement revenue declining and that being partially offset by an increase in milestones. There I highlighted KESIMPTA. I can also share with everybody on the call that in addition to the significant sales milestone KESIMPTA, we also have a relatively significant milestone related to Epcoritamab with the filing and acceptance of the filing in the U.S. for the refractory late line FL indication. That's another significant milestone. So it's probably about as much detail as we can give on revenue. In terms of OpEx, again, here, I think if you look at the detailed page that we presented really highlighting where the vast majority of the growth is going to our mid- to late-stage programs, particularly Epcoritamab is driving a fair amount of the year-over-year increase. And then secondly, behind that, you'd have 1046 and Tivdak with the potential launch of the Phase 3s there. And then there is still a substantial increase in investment doing continued expansion work for 1042 and also a fair amount of expansion work and other related work for our CD3 B7-H4 program. And as you can see, that's driving around -- in totality, the point that as mentioned are driving around DKK 1.6 billion of our total investment increase and I provided a lot of color in terms of SG&A and how we're really getting that number to scale. It's been a key focus area in terms of really driving operational performance, if you like, in our business and getting that number to scale. And as we exit Q4 of 2023, we feel we've made a ton of progress here moving forward. So that's the additional color I’d provide in terms of the top line revenue and the investments. Maybe Anthony Mancini, do you want to provide maybe any additional color, particularly as it relates to EPKINLY?
Anthony Mancini : Yes. Thanks, Anthony, and thanks, Jonathan, for the question. I think if I understand the question is a little bit about based on how our start has gone. What confidence do we have in our performance going forward to be the market leader. And I would say that the healthy uptick we’ve seen driven really by strong execution gives us a high degree of confidence that we can continue to retain our market leader status, particularly the reactions that we’re getting, the strong access that we’re getting in the U.S. And now that we know more about the profile really the feedback that we’re getting from customers and the enthusiasm based on the reactions they’re seeing with patients around not just the power of the overall responses, but the manageable safety profile and the seamless and efficient step-up dosing and subcutaneous administration as well as reduced patient in-office administration time and efficiency and throughput, we think we’re really well positioned to continue to retain a market leadership position, and we’re really excited about additional launches in the B-cell malignancy space with FL being next on the docket. So Jonathan, we feel really confident that we can continue to perform strongly going forward.
Operator: Now we're going to take our next question. And the next question comes from the line of Michael Schmidt.
Paul Jeng: This is Paul on for Michael. My question was touched on a bit in prior questions. But generally, what can we expect from your immunology efforts in the coming year, either internally or externally? Is this possibly an area of BD focus? And then along those lines, on your collaboration with Argenx, which I think is approaching a year, any near-term plans to disclose a target or program from that either in oncology or immunology?
Jan van de Winkel: I think I can handle those questions. So we have a lot of activity in the I&I area. And these are twofold, basically. We have our own programs. We have a number of programs with is Genmab working on itself. And we actually have a number of programs, and we actually expanded the number together with Argenx, where we actually work in I&I as well as in oncology. This year, you’ll probably not hear a lot from those programs, Paul, because we only actually speak about these programs once we have a clinical candidate selected to move into the clinic imminently because we learned that in the hard way. In the past, we don't get any credit basically for early-stage programs, which you flag up. But we get credit once they move into the clinic, and they begin to build further value for the company, for stakeholders. And so it is not from the Argenx or from our own programs. I think they are two early stages. We are in the process of selecting the clinical candidates. But we are certainly looking as it relates to investments in BD into candidates outside of the company, and that could be a repo to actually accelerate the development in the I&I area for Genmab by simply acquiring a product candidate in late-stage development or even commercial stage to develop further. And then as Anthony Pagano explained, leverage our considerable investments in development and also large-scale development of antibody-based medicines in that area. I think it's too early to say more explicitly speak about that. But we certainly are looking very, very proactively at the landscape. And we are looking at some candidate targets and timing is very difficult to give further color on. But actually, that is a realistic area where you could see progress from Genmab in 2024. I think we should move on to the next question, operator?
Operator: Now we're going to take our last question for today. And it comes from the line of Peter Welford.
Peter Welford: So just a question on the outlook, please. I guess, for Anthony. Really, the question is -- so I'm trying to just piece together the pieces as far as -- you talk about the fact that the reimbursement revenue that you're assuming within 2024, is going to decrease. But equally, you talked about a significant part of the investment in R&D is related to 1042 and 1046, which obviously are shared, I guess, with BioNTech. So I guess I'm trying to square that given that presumably 50% will be paid back to you. And equally, why the gross profit guidance less the forecast for the operating expenses doesn't give you the EBIT outlook. So what the sort of disparity is to get from gross profit down to EBIT based on your OpEx outlook?
Jan van de Winkel: Thanks, Peter. Anthony?
Anthony Pagano: Yes. Thanks, Peter. In terms of the reimbursement revenue and what you're pointing out, that number coming down, but investment in 1042 and 1046 and other BioNTech partnered programs going up, this is all true and both true at the same time. In terms of what's driving that, there are probably -- there are two things. First is the composition of the work that's being done by the parties. So to the extent that BioNTech is doing more work for certain of the programs, that will not flow through reimbursement revenue, will only pick up half of the cost. And secondly, for some of the larger investments we're making for 1042 and 1046, we have just looked at our overall setup with BioNTech in terms of how some of those contracts are set up with third parties and looking to optimize our cash flow. And some of that then translates through into slightly different accounting where I'm only picking up half of the cost in my P&L and not picking up 100% like we have done historically and then 50% coming back through the reimbursement line, Peter. In terms of your more granular question on this sort of very specific thing. I'm going to have to suggest that we take that, have you follow-up with Andrew, we can work through the mechanics of your other question as it relates to how the P&L all flows together.
Operator: Thank you. There are no further questions for today. I would now like to hand the conference over to your speaker, Jan van de Winkel for any closing remarks.
Jan van de Winkel: So thank you all for calling in today to discuss general financial results for 2023. And if you have additional questions, that is certainly possible, then please reach out to the Investor Relations colleagues from Genmab. We hope that you all stay safe, keep optimistic and remain healthy, and we very much look forward to speaking with you all again soon.
Operator: That does conclude our conference for today. Thank you for participating. You may now all disconnect. Have a nice day.
