Genmab A/S Q4 FY2025 Earnings Call
Genmab A/S (GMAB)
Call artefacts
No matching 8-K earnings release linked yet.
No 10-K stored for this quarter yet.
Call audio is not captured yet.
A slide deck is not captured yet.
Transcript
Auto-generated speakersHello, and welcome to the Genmab Full Year 2025 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 believes, 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, Genmab may hold your personal data as indicated by you as a 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 our first speaker today, Jan van de Winkel. Please go ahead.
Hello, and welcome to our financial results call for 2025. With me today is our Chief Financial Officer, Anthony Pagano; and our Chief Commercial Officer, Brad Bailey. For the Q&A, we will be joined by our Chief Medical Officer, Tahi Ahmadi; and our Chief Development Officer, Judith Klimovsky. As noted, we will be making forward-looking statements, so please keep that in mind. As we reflect on 2025, I would like to remind you of the commitments that we made at the beginning of the year. We said that we would accelerate the development of our high-impact late-stage pipeline, maximize the potential of our commercialized medicines, and deliver on our capital allocation priorities. I'm pleased to say that we have delivered on these commitments. And we begin 2026 with a diversified, high-quality revenue base and a late-stage portfolio that can drive sustainable growth well into the 2030s. In 2025, we grew total revenue by 19%, fueled by both our royalty portfolio and sales from our own medicines. We also invested fully in line with our capital allocation priorities. Importantly, we have also grown operating profit even while making these strategic investments. 2025 was marked by some significant milestones in our mission to deliver innovative medicines to patients. Highlights include positive momentum for EPKINLY as it continues to demonstrate the potential to become a core therapy in B-cell lymphomas, its FDA approval in second-line follicular lymphoma in combination with R2, as well as the unprecedented data in this indication are key milestones. Taken together, these move treatment into earlier lines of therapy and expand our impact for people living with follicular lymphoma. We also built on our commitment to the GynOc community. In addition to the availability of TIVDAK in both Japan and Europe, we expanded the development of Rina-S, ending the year with 3 Phase III trials across PROC, endometrial cancer, and PSOC. Finally, a pivotal step on our journey to sustainable diversified growth was our acquisition of Merus, which enhanced our late-stage portfolio with petosemtamab. With petosemtamab joining EPKINLY and Rina-S, we have a strong pipeline of late-stage assets that will provide us with multiple value-creating catalysts in 2026 and in the future. Now let's take a look at the strength of these 3 programs on the next slide. With the 5 combined breakthrough therapy designations, these 3 programs have multibillion-dollar potential, and they firmly underpin our long-term growth. EPKINLY is currently the only bispecific antibody with a dual indication across B-cell malignancies in the U.S., Europe, and Japan. Following unprecedented data, EPKINLY plus R2 is well positioned to become a best-in-class option in second-line plus follicular lymphoma. Rina-S is a folate receptor alpha targeted ADC designed to broaden eligibility beyond high expressers. Based on current expression distributions, this could expand the addressable population by as much as 3x versus approved medicines that are restricted to high folate receptor alpha expression. Finally, petosemtamab, a potentially transformative EGFR LGR5 bispecific antibody with compelling data in both first-line and later-line recurrent and metastatic head and neck cancer. As a reminder, in the first-line setting, petosemtamab in combination with pembro achieved a 63% response rate, which is more than 3x higher than the 19% that has been observed with the standard of care. 2026 will be a defining year for all 3 of these programs, as we will see on the next slide. We expect up to 6 potentially registrational data readouts that could set the stage for multiple important product launches and line extensions in 2027. In the second half of the year, we expect Phase II data for Rina-S in platinum-resistant ovarian cancer. We also anticipate that one or both Phase III trials for petosemtamab in first and second-line or third-line head and neck cancer will deliver top-line data in the second half. While we anticipate around 25,000 potential patients for later lines of therapy in first-line head and neck cancer, this increases to an additional 41,000 patients. For EPKINLY, we expect data from 2 Phase III trials in diffuse large B-cell lymphoma, with the indication having the largest addressable patient population, around 70,000 people is, of course, frontline diffuse large B-cell lymphoma, and we are looking forward to data in this indication in combination with R-CHOP this year. We are also looking forward to data in the first half of the year in second-line plus diffuse large B-cell lymphoma in combination with lenalidomide. As you are aware, in January, we announced top-line results from the Phase III EPCORE DLBCL-1 trial of EPKINLY monotherapy. The results showed an improvement in progression-free survival as well as improvements in complete response rates, duration of response, and time to next treatment. These represent the first Phase III study demonstrating an improvement in progression-free survival in patients with relapsed or refractory diffuse large B-cell lymphoma treated with the CD3/CD20 T-cell engaging bispecific monotherapy. Overall survival did not reach statistical significance and further analysis of the data is ongoing, including the potential impact of various factors, including COVID-19 and the increasing availability of novel anti-lymphoma therapies. The full trial results will be submitted for presentation at a future medical meeting, and we will engage with global regulatory authorities on next steps. The monotherapy results do not change our expectations for our other Phase III trials. We are very confident that these studies continue to have the potential to move EPKINLY earlier in the treatment paradigm and significantly increase its addressable population from approximately 27,000 patients today to almost 150,000 patients by early in the next decade. The data presented across EPKINLY, Rina-S, and petosemtamab in 2025 strengthened our conviction in these programs. Now in 2026, meaningful registrational readouts will be the catalysts that potentially bring these antibodies to patients in 2027. I'm pleased to now hand you over to Brad for a review of the recent commercial performance for EPKINLY and TIVDAK.
Thanks, Jan. 2025 marked another successful year for our commercialization team. We maintained leading positions for our proprietary brands globally and made important progress evolving into a wholly owned model, fueling our long-term growth engine. In the past year, we successfully executed 4 key launches across our portfolio, 2 of which were led entirely by Genmab, demonstrating the strength of the commercialization model we've built in the U.S., Japan, and now in Europe. We expanded our footprint to 3 additional markets, opening business operations in Germany, the U.K., and France, and we delivered on our commitment to bringing our antibody-based medicines to patients in an area of high need. To this end, TIVDAK became the first ADC approved in recurrent or metastatic cervical cancer in the EU, U.K., and Japan, providing a much-needed option for patients whose disease progresses after initial therapy and where outcomes have historically been poor. Additionally, with its approval in the U.S. in relapsed or refractory follicular lymphoma, EPKINLY became the first bispecific antibody approved in any form of non-Hodgkin's lymphoma in the second-line setting and the first bispecific combination therapy approved in the lymphoma space. These milestones represent progress for patients and set the foundation for our growth trajectory in gynecologic cancers, along with Rina-S in the future and further into B-cell malignancies. Through our efforts in 2025, sales of our proprietary medicines totaled $632 million. This is up 54% year-over-year and accounts for approximately 28% of our total revenue growth. We expect this growth trajectory to continue in 2026, grounded in the strong foundation we've built as we deliver our own medicines to an increasing number of patients around the world. Now let's take a closer look at EPKINLY. We closed out 2025 with solid performance, achieving $468 million in sales for the year, representing a 67% year-over-year increase. This performance was driven by continued growth for the brand across geographies as the first and only bispecific with approved dual indication in diffuse large B-cell lymphoma and FL in Europe, Japan, and the U.S. In fact, EPKINLY closed 2025 with regulatory approvals in more than 65 countries, nearly all of which feature the dual indication. We continue to be encouraged by EPKINLY's strong momentum and the positive feedback we hear from physicians across geographies regarding EPKINLY's differentiated clinical profile, powerful efficacy, proven safety, and the value of having a single dual indication option across DLBCL and FL. In the U.S., this momentum translated to sustained growth for EPKINLY across sites of care with an acceleration in new sites ordering, including in the community, and the majority of health systems now ordering from multiple sites. Following the launch of EPKINLY in second-line FL in November, we're seeing increased uptake suggesting that this approval will be a growth driver for the brand. In Japan, we continue to see EPKINLY's launch in third-line plus FL build on the brand's success in large B-cell lymphoma, driven largely by EPKINLY's dual indication differentiation and execution by our field teams to activate sites. Across all other markets, we continue to increase our presence through our partner, AbbVie, and its global footprint. We closed out the year with yet another quarter of solid sales for EPKINLY in these markets as we continue to see rapid uptake in countries gaining access and reimbursement. Looking ahead, 2026 will be a pivotal year for EPKINLY as we advance our position in early lines of therapy and anticipate key data readouts supporting EPKINLY's versatility and status as the core therapy in B-cell malignancies. Our focus is on delivering EPKINLY to as many patients as possible, particularly in early lines of therapy where we see the market opportunity, and critically where we may have the opportunity to truly transform the trajectory of these diseases for patients. To that end, we're maximizing our first-mover advantage in second-line FL in the U.S., and we expect to build on this opportunity across markets with anticipated approvals in this setting in Europe and Japan later this year. With this traction in earlier lines of FL, we're looking towards key readouts in 2026 in first- and second-line DLBCL with fixed-duration EPKINLY combination therapies to further strengthen EPKINLY's position in DLBCL. Together with a robust development program for EPKINLY and strong execution by our teams, we see a clear opportunity for EPKINLY to achieve blockbuster status over the next few years. Moving now to TIVDAK. TIVDAK continues to be recognized as the global standard of care in recurrent or metastatic cervical cancer. In 2025, TIVDAK generated $164 million in sales, representing a 26% year-over-year increase. TIVDAK continues to perform well across both new and established markets, highlighting the clear need for treatments that improve survival for women with advanced cervical cancer worldwide. In the U.S., notably, TIVDAK posted its fourth consecutive year-over-year growth, underscoring its continued market leadership. This strong, stable performance continues to be driven by the depth and breadth of sites of care using TIVDAK. In Japan, TIVDAK demonstrated another strong quarter, underscoring the traction it's gaining in the second-line setting and the high patient need in recurrent and metastatic cervical cancer in the country. This trend continued in Europe, where the launch in Germany continues to be off to an encouraging start with strong, consistent uptake and positive physician feedback. As the first medicine we've launched in Europe independently, our efforts in recent months have demonstrated our ability to strategically build infrastructure and scale in new markets. We received MHRA approval in December in the U.K. and are now working towards reimbursement to bring TIVDAK to more patients as soon as possible. As we look ahead to the new fiscal year, we have the foundation in place to continue this momentum and bring TIVDAK to additional markets. Infrastructure and operations are well underway in new markets, with our teams executing in preparation for exciting launches on the horizon. We expect to see continued positive performance across markets as we strengthen and scale our presence and broaden our impact within the gynecologic cancer community. Wrapping up, 2025 was a critical year in our company's evolution. We built on our proven launch expertise and scientific strength and achieved key milestones to solidify our commercialization model and business operations that will unlock our ability to deliver on the significant growth opportunities ahead of us. Our proven ability to evolve our model in the U.S. and Japan, coupled with the early traction we are seeing in Europe, gives us the confidence that we have the pieces in place today to drive future growth and expansion. With this strong foundation, 2026 is shaping up to be another meaningful year for Genmab. We will grow the impact of our proprietary portfolio, expand our footprint, and sharpen our capabilities as we look to enter new and larger market opportunities and deliver on the blockbuster potential of EPKINLY, Rina-S, and petosemtamab in the coming years. With that, I'll hand the call over to Anthony to discuss our financials.
Thanks, Brad. 2025 was a year of strong execution for Genmab with solid revenue growth, expanding profitability, and disciplined investment. Looking ahead, our 2026 guidance reflects the same framework we outlined at Q3 and at the time of the Merus acquisition. It also reflects our continued commitment to funding growth while maintaining substantial profitability. Now before diving into the numbers, please note that the results and guidance I will review exclude the impact of acquisition-related expenses, including amortization. A reconciliation to our reported results is included in the appendix. In 2025, total revenue increased 19% to $3.7 billion, reflecting strong execution across our royalty portfolio as well as continued progress for our commercialized medicines. We also continue to improve the quality of our revenue profile with a higher contribution from our own medicines, especially EPKINLY, further diversifying our revenue base. In addition, we strengthened our long-term growth potential with the addition of petosemtamab to our late-stage pipeline. Alongside the Merus acquisition, we made targeted strategic investments during the year, with operating expenses up 13%. The investments we've made in building our commercialization capabilities are already delivering for us today. Importantly, they are positioning us to support expansion into earlier lines for EPKINLY and the potential launches of Rina-S and petosemtamab in 2027. Even with these investments, we expanded operating profit to $1.26 billion, reflecting strong execution and increasing operating leverage as the business scales. Overall, 2025 demonstrates the strength and quality of Genmab's underlying financial performance. Turning to our 2026 guidance, our framework is straightforward. Revenue growth enables strategic investment, which supports long-term value creation. At the midpoint, we expect 14% total revenue growth, driven by continued momentum in EPKINLY and our royalty portfolio, further enhancing revenue quality. More specifically, we expect DARZALEX net sales in the range of $15.6 billion to $16.4 billion. As discussed previously, expectations for operating expenses are reasonable. For 2026, the increase in operating expenses reflects planned investments to advance late-stage development for petosemtamab and Rina-S, as well as launch readiness activities to support multiple potential product launches. Even with the strategic step-up, our guidance delivers on our commitment to maintain substantial profitability in 2026. With that, I would like to provide some context for how revenue growth supports a deliberate increase in investments while delivering $1.15 billion of operating profit at the midpoint for 2026. What stands out is the strength of our underlying business, demonstrated by strong organic operating profit growth before our planned investments in petosemtamab. We are choosing to reinvest part of the operating leverage now to strengthen future growth drivers while continuing to actively manage costs and maintain profitability discipline. This balance, reinvesting to support growth while driving substantial profitability is a core feature of our operating model. Taken together, our 2025 results and 2026 guidance demonstrate consistent delivery against our financial commitments. Our capital allocation framework remains fully aligned with our strategy to drive sustainable growth well into the 2030s. First, we will continue to invest to accelerate our late-stage pipeline and maximize the success of our commercialized medicines, including launch readiness. These investments are intended to generate meaningful revenue for us in the future. Second, we will continue the rapid integration of Merus to accelerate value capture while maintaining focus and prioritization. Third, we remain committed to deleveraging, targeting gross leverage below 3x by the end of 2027, maintaining balance sheet strength and flexibility. In summary, our performance in 2025 underscores our ability to deliver revenue growth, advance key pipeline assets, and maintain strong profitability through disciplined execution. Looking ahead to 2026, we are building on this momentum through disciplined prioritization of our investments, continued operating discipline, and expansion of market opportunities. This positions us for sustained growth and long-term value creation. On that note, I'm going to hand you back over to Jan.
Thank you, Anthony. Our confidence in our ability to execute on key data readouts in 2026 and subsequent high-impact launches in 2027 come from our track record. We have proven that we are excellent evaluators of innovation and that we deliver on our promises. We have also proven that we are disciplined in our execution against our capital allocation framework and in the prioritization of our investments, and we are committed to delivering profitable growth. Genmab is a scaled oncology biotech business with strong momentum, an increasingly diversified growth profile, and multiple catalysts ahead. As we begin 2026, our focus remains on translating our antibody science and development expertise into meaningful breakthroughs for patients and long-term value for shareholders. That ends our formal presentation. Thank you for listening. Operator, please open the call for questions.
And now we're going to take our first question, and it comes from the line of Jonathan Chang from Leerink.
Can you discuss what the next steps are for EPKINLY following the results of the EPCORE DLBCL-1 study? Can you still get the second-line plus label with the EPCORE DLBCL-4 combination study? And what was the rationale behind using the monotherapy DLBCL-1 study as the confirmatory study in the first place?
Thanks, Jonathan, for the questions. I will hand it over to Tahi to explain in further detail what the next steps are for the regulatory part.
Yes. Thank you, Jan, and thank you, Jonathan, for the question. Yes, as we already indicated in the press release, the study is positive by PFS as a single agent beating a chemo-immuno regimen. However, it missed the overall survival confounded by aspects that are already discussed in the community. One is being COVID; the study was involved heavily during the Omicron wave. The second is the emergence of access to bispecifics, of which we are an important part. We will have this discussion with the agencies. There are prespecified analyses in the protocol that were already agreed prior to the readout on these 2 major biases. We will have this discussion with both the FDA and European health authorities, and we will communicate with you once it is in the public domain. Regarding the rationale for why this is the confirmatory study, it's important to remember when this program started. This was the first Phase III to be initiated. Hence, it was a confirmatory study because the requirement for an accelerated approval is that you have a confirmatory study initiated and well-enrolled by the time you file for accelerated approval. This was initially the only diffuse large B-cell study. Discussions are ongoing with the agencies about all the other Phase III studies we have ongoing to specifically demonstrate that we will have a readout this year. There is no indication from our end, nor any readout to the failability of the other study that is being conducted, which we already indicated will read out in the first half of this year; this is a different study with different opportunities.
Thanks, Tahi. Jonathan, I think that answered your question?
Understood. Thank you very much.
The next question comes from the line of Asthika Goonewardene from Truist.
So you presented EPCORE outpatient data late last year. I just want to get an update on how this data has been adapted to change in practice in the U.S. I guess, could you give us an idea of what proportion of community clinics still send DLBCL patients to large centers to get that step-up dose monitoring? Additionally, could you reassure us about the likelihood of convincing the regulatory agencies to consider one of the other EPCORE Phase III study readouts that are coming this year as the confirmatory study?
Thanks, Asthika, for the questions. I will first hand it over to Tahi; then Brad will definitely be able to comment.
Yes. Thank you, Asthika, for this question. We have, at this point, 3 Phase IIIs in diffuse large B-cell lymphoma. One that we already announced the results on, and then 2 more that are set to read out this year, one in the first half at least, and the other one we have not committed to defining. We are very comfortable regarding the confirmation trial, particularly with precedent already set with other programs. As for outpatient, I'll leave it to Brad.
Yes, Tahi. Dovetailing off that, you're absolutely correct. We do see this as an enabler. As we continue to evolve and receive physician feedback, moving into even earlier lines of therapy, we see this as a significant opportunity for us.
Now we're going to take our next question. And it comes from the line of Xian Deng from UBS.
I have one on Rina-S, please. Given the pivotal Phase II that's due to come out this year, and considering this is a pivotal Phase II and it's not a formal Phase III, I'm wondering what determines when you can decide to have a readout. Also, for EPKINLY frontline DLBCL trial, could you confirm whether you have passed the interim?
Thanks, Xian, for the questions. The first one, I will ask Judith to address, and then Tahi can give a brief answer about the interim question.
Yes. Thank you for the question. The study was designed as pivotal with a potential outcome supporting accelerated approval, which is a path the FDA has when the results predict substantial benefits over the current standard of care. The Phase II design includes ORR and duration of response, our validated endpoints for clinical benefit. The accelerated approval also depends on having Phase IIIs with clinical endpoints.
Thank you, Judith. Tahi, can you provide some information regarding the frontline diffuse large B-cell lymphoma study?
Thank you for the question. We expect the readout for that study to happen in 2026.
Now we are going to take our next question and it comes from Rajan Sharma from Goldman Sachs.
Could you discuss your expectations into the EPCORE DLBCL-4 trial? What do you think is a clinically meaningful outcome relative to LUNSUMIO and POLIVY?
Thanks, Rajan, for the question. Tahi, can you address the DLBCL-4 question?
The anticipation is that it will be a trial that will be registered, which differentiates it from the studies you mentioned. This study is set up to test a combination regimen with lenalidomide and was enrolled exclusively after the Omicron wave, which was a significant confounder for many studies with bispecifics. We are excited and look forward to this dataset, which will also have a larger portion of second-line patients. The expectation is that this trial will be positive and lead to registration in second and third lines.
Thanks, Tahi. Let us move to the next question.
And now, we're going to take our next question from Judah Frommer from Morgan Stanley.
Just curious on your thoughts on the pembro approval in PROC recently, and its implications for Rina-S. Additionally, could you share any high-level thoughts on the DARZALEX trajectory over the coming years?
Thanks, Judah. Judith, can you start and perhaps Tahi can chip in.
We are aware of the data and the approval; it's a good potential option for patients. However, please note that the approval is in PD-L1 positive CPS above 1%, which encompasses around 70% of the population, and the combination includes chemotherapy, which is significant for patients. It is great that patients have another option. However, we believe that Rina can be more transformative and serve the full broad population.
Thanks, I think that addresses your question, Judah. So let's move on to the next one.
The next question comes from the line of James Gordon from Barclays.
A question on EPKINLY in first-line DLBCL. What are you hoping to see in terms of OS benefit, and what is the efficacy bar? How do you expect to compare against POLIVY, particularly given Roche is also developing a CD3/CD20 combo?
Thank you, James, for the questions. These are very exciting questions. Tahi, let's see what you answer.
The primary endpoint is PFS. We believe that the combination will be transformative. The data needs to show this, and our robust Phase II datasets have been quite informative in guiding our development. There is a reason for enthusiasm and expectation on our part that this study will be positive. As it relates to OS, you're right; in diffuse large B-cell lymphoma, OS is an endpoint that lags. This will be a discussion we can have once we recognize the dataset and can evaluate the improvement in PFS and its translation to us.
Thanks, Tahi. We have to leave it with that, but that was a very good answer. Thanks, James, for the question. Let's move on to the next question.
And the next question comes from the line of Zain Ebrahim from JPMorgan.
Can you clarify on EPKINLY; how is the events tracking running relative to your expectations? Additionally, following the Merus acquisition, have you spoken to the FDA about trial designs for ongoing Phase III trials, and based on those conversations, how confident are you that the response rate is sufficient as a regulatory endpoint?
Thanks, Zain, for the question. I will ask Tahi to talk about events tracking, and then Judith can respond about the design.
On events tracking, while we do track these metrics, this is not something we can discuss in calls like this.
Thanks. Now let's move on to Judith.
The 2 Phase III studies have dual endpoints of ORR and OS. In areas of unmet medical need, the FDA is open to earlier endpoints that can predict overall survival. We feel good about the design for both studies.
Thanks, Judith. Thanks, Zain. Let's move on to the next question.
And the next question comes from the line of Suzanne van Voorthuizen from Van Lanschot Kempen.
For petosemtamab, are we expecting a Phase I/II data update in head and neck cancer during this year at a medical conference? If so, could you elaborate on what you believe the expectations should be on duration metrics and survival?
Thanks, Suzanne. I will ask Judith to comment on that.
The last readout for the peto-pembro combination went through around 15 months of follow-up, which allowed us to see 79% of patients at 12 months landmark overall survival. There is some censoring involved, but the censoring happened past the 12 and 16 months, which is expected from the control arm. The last ASCO presentation provides useful information for the probability of success of the Phase III trial, and we planned to update you as data progresses.
Let's move on to the next question.
And our next question comes from the line of Yaron Werber from TD Securities.
Quick follow-up on the OrigAMI-5 study. Given that it uses KEYTRUDA and chemo, would you consider a similar trial design with peto?
Judith, can you address Yaron's question regarding the OrigAMI-5?
We stand behind our original strategy of combining peto with pembro. Given our data with peto, we believe the CDP could expand in many directions. However, we believe the chemo-free combination is a strong value proposition.
More to come.
And the next question comes from the line of Qize Ding from Rothschild & Co.
I noticed that petosemtamab is at Phase II stage for combining pembrolizumab in first-line non-small cell lung cancer. Did this trial start in Q4 2025? What are your high-level thoughts and expectations behind this study?
Thanks, Qize, for the question. Judith, can you comment on the lung cancer trial for peto?
Yes, the study was planned as a signal-seeking study, targeting indications where cetuximab shows maximum benefit in combination with pembro, given the known synergy between peto and pembro. We will update you when we have data.
Thanks, Judith. Thanks, Qize, for the question. Let's move on to the next one.
And the next question comes from the line of Matthew Phipps from William Blair.
You listed an additional Phase III for peto in 2026. Is that the locally advanced trial that you've already discussed, or is it something different? Do you anticipate providing any update from the colorectal cancer cohorts that we saw in the fall?
Thank you, Matt, for the question. Judith, can you address both?
Yes, the data presented in December on colorectal was encouraging, albeit with a limited number of patients. Each cohort enrolls 40, 40, and 60 patients. The dataset is growing, and we plan to inform the medical community as this develops. In terms of future Phase IIIs, we have already mentioned the locally advanced head and neck study and actively work on a comprehensive clinical development plan.
Thanks, Judith. Let's move on to the next question.
And now we're going to take our next question, and it comes from the line of Victor Floch from BNP Paribas.
Your early-stage pipeline has significantly streamlined over the last 12 months. Do you believe you have enough candidates in-house? Should we expect early-stage M&A at some point?
Victor, we have recently filed 3 INDs: one for a bispecific antibody, one for an ADC, making use of the linker and payload technology acquired via ProfoundBio, and another for a bispecific using the HexaBody technology. Our pipeline is diversified, with 45% ADCs, 50% DuoBody, and 5% HexaBody based. We are integrating the Merus pipeline while prioritizing high-impact candidates for further development. Tahi can provide more color on the organic pipeline.
We’ve recently filed 3 INDs with expectations of more to come this year. Our focuses after the integration will be in antibodies and the next-generation ADC platforms, increasing our interest in research capabilities. The landscape is changing, and we are also thinking about combinatorial strategies for our internal assets.
Now we are going to take our next question. And the question comes from the line of Mattias Haggblom from Handelsbanken.
On peto, what additional information would you need from ongoing or future clinical trials to specify your peak sales potential from multibillion-dollar to an actual number?
Thanks, Mattias. I will hand it over to Anthony Pagano to discuss the multibillion-dollar potential of these molecules.
As we've stated since the acquisition, we're encouraged by the data for petosemtamab, and its potential for breakthrough therapy designations. We're looking forward to pivotal readouts in 2026 and the potential to expand into earlier lines. For now, we maintain our guidance of multibillion-dollar blockbuster potential, and as we refine our CDP and observe more data, we will look for the right time to update guidance.
Thanks, Anthony. Let's leave it at that, Mattias, but thank you for the question.
And now we'll take our next question from the line of Sarah B from Guggenheim Partners.
I want to circle back to Rina-S. Can you comment on the size of the opportunities both in and outside the ongoing Phase II? Also, if you could clarify the terms of the debt offering announced late last year.
Thank you, Sarah. Anthony, can you address the size of Rina’s opportunity and the debt offering terms?
For Rina-S, like petosemtamab, we're very excited about this asset, with guidance of $2 billion plus underpinned by second-line PROC, second-line endometrial, and second-line PSOC. We've initiated Phase III trials for these indications. Regarding the debt offering, we experienced strong demand from quality investors. The offering totalled $5.5 billion, with roughly $2.5 billion fixed and $3 billion floating rate debt. We have hedged around $1.6 billion for the floating part to make it fixed, resulting in $4.1 billion fixed overall. We're committed to getting below 3x gross leverage by the end of 2027.
Thank you, Anthony. Thanks, Sarah, for your questions. Let's see if there are any further questions. Operator?
Now we’re going to take our last question for today. And it comes from the line of Benjamin Jackson from Jefferies.
Conscious of time, just one for me. How are you thinking about the sales and marketing investments needed ahead of any potential launches? How comfortable are you with the current team size and geographic locations?
Thank you, Ben. I will ask Brad to give you feedback on this.
We continue to be disciplined on operational expenses as guided. We'll invest strategically to strengthen the development and commercialization to bring our medicines to as many patients as possible. We're pleased with where we are today, with both U.S. and Japan showing early signs of good performance in Europe. We look forward to sharing more in the near future.
More to come, Ben, in the future.
There are no further questions today. I'll hand the conference over to Jan van de Winkel for closing remarks.
Thank you for calling in today. If you have additional questions, please reach out to our Investor Relations team. We very much look forward to speaking with you again soon.
This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.