Hello, and welcome to the Genmab Q1 2022 conference call. Throughout the call, all participants will be in listen-only mode, and afterwards there'll be a question and answer session. Just to remind you, this conference call is being recorded. During the teleconference, 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.
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Today, I am pleased to present Jan van de Winkel. Please go ahead with your meeting.
Hello, and welcome to the Genmab conference call to discuss the company's financial results for the period ended March 31, 2022. With me today to present these results is our CFO, Anthony Pagano. Let's move to slide 2. As 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. Genmab has an innovation-based culture, and collaborations and partnerships have always been part of our DNA.
During today's presentation, we will reference some of the products being developed under these strategic collaborations, and this slide acknowledges those relationships. Let's move to slide 4.
I would like to begin with a reminder that thanks to our consistent and solid track record of success, our world-class team and our strong financial foundation, we have never been in a better position to achieve our ambitious vision of transforming cancer treatments. During the first quarter of 2022, we continued to build on this foundation with multiple advancements in our pipeline. Now let's move to slide 5 and take a look at some of the recent achievements and updates.
I'm excited to start with the fact that last month, we and AbbVie announced top-line results from the first cohort of the phase 1-2 study of epcoritamab in patients with relapsed or refractory large B-cell lymphoma who have received at least two prior lines of systemic therapy, including 38.9% who received prior treatment with CAR T therapy.
In these high-risk, heavily pretreated patients, epcoritamab demonstrated an overall response rate of 63.1% with a median duration of response of 12 months. The data will be submitted for presentation at a future medical meeting, and based on these results, together with AbbVie, we will engage global regulatory authorities to determine next steps. In March, we announced another important milestone for epcoritamab, that the FDA has granted orphan drug designation for the treatment of follicular lymphoma. Let's now turn to tisotumab vedotin.
Together with Seagen, we presented tisotumab vedotin data at a number of conferences during the first quarter. Key among, these presentations was preliminary data from the Innovative 207 study of tisotumab vedotin monotherapy in patients with squamous cell carcinoma of the head and neck who experienced disease progression on or after a first-line platinum-containing regimen and a checkpoint inhibitor.
Early results showed tisotumab vedotin demonstrated manageable safety profile and promising preliminary antitumor activity in this patient population, with the primary endpoint of confirmed overall response rate per investigator achieved in 16% of head and neck cancer patients. The findings were presented as part of a plenary session at the ASTRO 2022 Multidisciplinary Head and Neck Cancer Symposium in Arizona in February. We also presented interim results from the Innovative two-oh-five study during a virtual oral session at SGO in March.
Excitingly, as you may have seen, on the ASCO 2022 website, an abstract on the Innovative two-oh-five data was also accepted for oral presentation at ASCO. This is one of multiple tisotumab vedotin and epcoritamab abstracts that have been accepted for presentation.
Our clinical pipeline also expanded in the first quarter with the first patient dosed in the first-in-human study of DuoBody-CD3xB7H4. The power of Genmab's innovation was reflected in updates for therapies created by Genmab that are being developed by other companies. A variety of programs either added or initiated clinical studies.
With regard to Janssen's products incorporating our DuoBody technology, as Janssen announced, they submitted a marketing authorization application to the EMA seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma and their U.S. FDA BLA for teclistamab in this indication received priority review from the U.S. FDA.
Sales for DARZALEX over the quarter were also strong, and we reported $1,856 million in net sales by J&J, an increase of 36% over the first quarter of 2021, resulting in DKK 1,501 million in royalties. This brings me to the resolution of our arbitration with Janssen relating to our daratumumab license agreement. As we announced in the beginning of April, the arbitral tribunal decided both issues in favor of Janssen. We did not seek a review of the awards, and it's now final.
As the arbitration is confidential, we do not intend to comment further, and we look forward to our continued collaborations with Janssen. Finally, we expanded our executive management team on March first with the appointment of Birgitte Stephensen to Chief Legal Officer and Chris Cozic to Chief People Officer.
These appointments elevate the critical work of their groups as well as further strengthens our world-class executive management team. I'm pleased to now turn the call over to Anthony Pagano to take you through our first quarter financial results. Anthony, go ahead.
Great. Thanks. Thanks, Jan. Let's move to slide 6. First off, as Jan just said, we're not gonna comment any further on the arbitration, but as a reminder, we already assumed a royalty reduction of around DKK 700 million when we issued our 2022 guidance in February. Now, with that behind us, let's take a look at Q1, where we continue to strengthen our foundation and drive towards our 2025 vision. Our first commercial launch, bringing Tivdak to U.S. Cervical Cancer patients, is progressing well. We grew recurring revenue by 84% in Q1.
This was driven by strong royalties from DARZALEX and other approved medicines. You'll remember, of course, that we essentially had no TEPEZZA revenues in Q1 of last year. Now, especially in these volatile times, the strength of our financial profile really stands out.
Our strong balance sheet and growing recurring revenues allow us to continue to invest in our business and our pipeline in a very focused and disciplined way. An important part of this has been to continue to build the team and capabilities to enable us to succeed. Let's take a look at those revenues in a bit more detail on the next slide. We saw continued strong performance for DARZALEX in the first quarter. You can see that in this chart.
Overall, net sales grew by 36%. That's net sales of $1.86 billion, which translates to DKK 1.5 billion in royalty revenue. This exceptional growth was driven by continued strong market share across all lines and continued uptake of the subQ formulation. DARZALEX remains a key driver of our revenue, as you can see on slide eight.
Our recurring revenues grew by 84% in the first quarter of the year. We've already spoken about DARZALEX and the very strong performance there. We're also encouraged by the growth of Kesimpta and TEPEZZA, where we saw an increase of almost DKK 300 million in royalties compared to last year. This growth really illustrates the power of our recurring revenues. In fact, 88% of our Q1 revenue was recurring revenue, and that's compared to 64% in Q1 of last year.
So our revenue profile continues to get stronger, and we're taking those revenues and investing in a highly focused way, as you can see on the next slide. In line with our significant growth opportunities, total OpEx grew 53% in the first quarter. Here you can see where we invested.
We accelerated our investment into our product portfolio, especially the advancement of both Epco and DuoBody-CD40x4-1BB. We've also further strengthened the Genmab team to support our growth and commercialization and our expanding pipeline. That includes supporting Tivdak and preparing for the potential filing and launch for Epco. Finally, we're leveraging our collaboration with AbbVie by utilizing their expertise and significant financial contributions to further expand and accelerate our partnership programs.
Now, let's take a look at our financials as a whole on slide 10. Here you can see our summary P&L. Revenue for Q1 came in at approximately DKK 2.1 billion. That's up 34% on last year. Total expenses were about DKK 1.6 billion, with 72% being R&D and 28% SG&A. We expect our investment levels to ramp up during the year as our pipeline and launch readiness activities continue to progress.
We again reported very strong operating profit. For me, this result is particularly impressive given the context. Why do I say that? Last year's Q1 makes for somewhat a tough comparator as it included more than DKK 400 million of milestone payments. This year, we've also increased our total investment in Q1 by more than DKK 500 million. Even considering these items, we still delivered some DKK 514 million of operating profit for the quarter.
Turning now to our net financial items. Here we have income of DKK 98 million, which was primarily driven by two partially offsetting items. First, we have the strengthening of the US dollar against the Danish kroner positively impacting the value of our cash and investments.
On the other side of the ledger, we have losses on our marketable securities due to rising interest rates and some losses on our public equity investments that we made in conjunction with recent licensing deals. We have tax expense of DKK 147 million, which equates to an effective tax rate of 24%. That brings us to our net profit of DKK 465 million. As you can see, extremely strong financial performance for the first quarter of the year.
Now, before we turn to our 2022 guidance, I want to take a minute to revisit our robust financial framework on the next slide. First off, let's think about our revenue profile, which you can see on the left. At the beginning of 2020, DARZALEX was our only product on the market.
Today, we have 5, and that provides us with expected recurring revenue growth of 40% in 2022. There's a clear path to potentially expand the number of approved products with Janssen's BLA for teclistamab and our planned submission for epco this year. Taken together, we expect significant cash inflows for us in the years to come. Moving to the right, we continue to be focused in our investments as we evolve our organization for continued success.
At the top of the list is accelerating and expanding the development of epco. Based upon the work we've done so far and the data we've seen, including the recent top line data, we're convinced epco is a drug that has the potential to really make a difference for patients. Epco is just one of the exciting opportunities that provide us with a compelling rationale for increasing our investment.
As we told you before, if we want to seize these meaningful opportunities, we've got to invest, and that's exactly what we continue to do. With that background, let's look at our guidance on slide 12. Driven by strong DARZALEX growth, we are updating certain aspects of our 2022 guidance. We now expect our revenue to be in a range of DKK 11-12 billion, and that's an increase of DKK 200 million to the bottom end of our range.
This increase is primarily driven by higher DARZALEX royalties following the strong Q1 performance. Here, we've increased the bottom end of our guidance range for DARZALEX net sales from $7.3 billion to $7.5 billion while keeping the upper end of our range at $8 billion. Our OpEx guidance remains in the range of DKK 7.2-7.8 billion.
As I've previously highlighted, this 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 3.2 billion-DKK 4.8 billion. Finally, we've maintained our guidance rate for the Danish kroner U.S. dollar at 6.4. Clearly, as we've all seen, there's been some rather significant volatility here, and that may continue.
Now, to give you just a bit of color on this topic, every 10-point move in this exchange rate relative to our guidance rate is worth around DKK 70 million in our operating income. Now, for my final slide, let me provide a few closing remarks. In summary, we've had a very solid start to the year, and we continue to execute against our 2025 vision.
We've created growing recurring revenue streams, and that gives us a strong backbone of significant underlying profitability. 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. On that note, I'll hand you back to Jan to discuss our key priorities for 2022.
Thanks, Anthony. Let's move to slide 14. Our key priorities are essential to our success, and thanks to the excellent work and tireless dedication of our team members, we are on track to meet these goals. We will continue to focus our resources progressing, expanding, and developing our world-class antibody product pipeline and on further scaling our organization based on our planned innovative portfolio developments.
We very much look forward to providing you with updates on our clinical programs over the course of this year as we continue to evolve into a leading, fully integrated biotech innovation powerhouse. Let's move to our final slide. That ends our presentation of Genmab's first quarter 2022 financial results. Operator, please open the call for questions now.
Thank you. If you wish to ask a question, please dial 01 on your telephone keypads now to enter the queue. Once your name has been announced, you can ask your question. If you find your question has been answered before it's your turn to speak, you can dial 02 to cancel. Please, in the interest of time and fairness, limit yourself to one question per turn. You can rejoin the queue to ask more questions. Our first question comes from the line of Peter Verdult of Citi. Please go ahead. Your line is open.
Thank you, Pete with Citi. Anthony, thank you for the clarification and sensitivity on the FX. My only question then is, Jan, anything incremental you can say on the ongoing HexaBody-CD38 dose escalation study, as well as the timelines for the FASPRO head-to-head and the DLBCL studies that I believe are part of the requirements relating to the J&J potential opt-in. Thank you.
Thanks, Peter, for the question, questions. HexaBody-CD38 is going very well. We are still testing out some different doses for HexaBody-CD38. In the second half of this year we're going to initiate the head-to-head against SubQ daratumumab in multiple myeloma patients. The diffuse large B-cell lymphoma cohort will probably be added next year, Peter. We will hope to progress first with the multiple myeloma head-to-head against SubQ daratumumab.
Thank you.
Thank you.
Thank you.
Thank you. Our next question comes from the line of James Gordon at JP Morgan. Please go ahead. Your line is open.
Hello, James Gordon, J.P. Morgan. Thanks for taking the question. My question is about confidence in epco filing. One question but two parts. For our R/R DLBCL and follicular, how different will the data that you actually intend to potentially file on be to the data we've already seen? So are you going to be enrolling or need the data on a lot more patients or much longer follow-up, or have we substantially seen the data now that you're going to file on? The other part of the question was just, I know FDA's got a bit tougher on blood cancer drugs and single-arm studies for a different class, the PI3 kinases.
Have you had a chance to have interactions with the FDA since some of their commentary has come out?
Any concerns that FDA might be tougher on single-arm studies or that's not a worry?
Thanks, James, for the questions on epco and the potential filing of epco. We are very excited about the data. This will be the data you've seen in the top line results, James. All the data we are going to present at a conference and all the data we are going to share with not only the FDA but also with other regulators. I can assure you that a lot of data you haven't seen yet. I mean, this is a very heavily pretreated population, and we have not told you anything yet on complete responses, duration, et cetera, of those responses and other column in the data set. We believe the data set is very encouraging.
We have scheduled meetings with the FDA on this data. We believe that because of the unmet medical need here and the strength of the data that we actually are very encouraged by the prospect of moving this forward towards a filing. I don't think that is necessarily impacted by the very stringent way the regulators looked at the PI3 kinase inhibitors recently. I think this is a very different situation. Of course, James, we need to first hear the feedback from the regulators. We also are going to move forward in other territories than the U.S. with this data.
We can't wait to share it with you and with all others at a medical meeting, which will hopefully be in the middle of this year. We are very excited about sharing the data with the medical community. I think we have caught up quite a bit with some of our competitors like Roche and Regeneron. I think the data set continues to be very strong. We are also going to share other data at, for example, ASCO and several other meetings in the coming time, which are data of combination therapies in different settings, which we are very, very excited about how they progress.
No, I think epco is basically developing very well, James. We are highly encouraged by the data. That's probably where I should leave it at this time.
Thank you.
Thank you. Our next question comes from the line of Wimal Kapadia at Bernstein. Please go ahead. Your line is open.
Oh, great. Thank you very much for taking my question. Can I just come back to the HexaBody-CD38, please? Just, Jan, I want to get your view on what's the real unmet need for a superior CD38 in myeloma? You know, DARZALEX's pretty good. How much higher can you actually push the efficacy bar? You know, is it a case of a year on PFS in first line, could it be more? And then just, you know, tied to that, is it really then the non-myeloma indication, which could be the more interesting opportunity? Thanks.
Yeah. Thanks, Vimal, for the questions. We believe that with a molecule which is at least tenfold and in some experiments hundredfold more potent than daratumumab, that there is actually a room to really push the responses further. For example, Vimal, when you look at the data of daratumumab monotherapy versus teclistamab, the CD3 BCMA bispecific created with the DuoBody technology from Janssen, the data from teclistamab is a lot better than the monotherapy daratumumab data.
I think there is room, I think, to further improve on the efficacy of daratumumab for sure in multiple myeloma, even better in other indications like AML, diffuse large B-cell lymphoma.
Potentially the biggest, I think, potential impact the HexaBody-CD38 could make is in solid cancers because there was still very strong data, Wimal, you know, in the effect of anti-CD38 antibodies in actually stimulating the immune system to attack cancer in animal models. That has not yet led to convincing data in the clinic with daratumumab. Also not with Sarclisa from Sanofi.
I think a far better molecule which can actually kill tumors with lower levels of expression of CD38, and that's definitely what we see with HexaBody-CD38 in the laboratory, could be very meaningful, I think, to broaden the market.
We also see a very good possibilities in multiple myeloma, and I think that is shared with what Janssen is seeing because we are having a very open interaction with Janssen. We share the data of HexaBody-CD38 with them. I think finally, what could be a possibility is to develop the candidate therapeutic Vmal in other indications like autoimmune diseases. Because remember, we have already in the early 2005-2006 timeframe, we had fantastic data in like SCID-RA models and other autoimmune models with daratumumab.
Janssen never developed it in autoimmune, which may be related to the fact that it is difficult to dose, as you look at the dosing, because you need completely different doses in cancer therapy versus autoimmune diseases. It may be difficult to price a drug which is used in autoimmune and cancer. But when you have a completely novel drug, Vimal, which is working well and is super potent in targeting CD38, perhaps the biggest opportunity is in diseases outside of cancer. I think that's all speculative as we speak, but we're super excited about what we see in the data, Vimal.
We are going to share that with you, the dose escalation data, hopefully also at the end of the year, some early head-to-head data against the subQ Dara, which is arguably one of the most successful medicines ever developed for a heme indication. I heard recently that this is the fastest launching medicine ever in heme, Daratumumab. I think, yeah, it is a good hurdle to beat, Vimal. I think if there is any molecule which has the potential to do that targeting CD38, it is HexaBody CD38.
We are really, really encouraged by what we see. What I told you already in December last year is the safety profile looks very, very good and clean, which is I think where we were most worried about, not the efficacy.
We can't wait, Wimal. This is going to be a very good year as it relates to, I think, data, clinical data from Genmab. I can assure you.
Oh, thank you.
Thank you.
Thank you. Our next question comes from the line of Peter Welford at Jefferies. Please go ahead. Your line is open.
Hi. Thanks for taking my question. It's actually a sort of contract legal question, if like in the sense. I noticed that the report says that epcoritamab uses a CD20 antibody that's derived from Medarex. Now, if I recall, all of the core ultimab technology came from Medarex. I wonder if you can just go. Has the number of paid-up initial licenses to Medarex expired? You know, which products, if any, in your pipeline are potentially now eligible for royalties, if you can say that, on the Medarex technology, if that still applies.
Apologies if that's completely off base, but wondering if you possibly just outlined your obligations under that IP. Thank you.
Thanks, Peter, for the question. I don't know whether we have any slots left under the original Medarex agreement. I don't know whether that's actually public information, Peter, so we may have to come back to you and others on that. What I can tell you is that basically we use a variety of technologies now, also other technologies to create antibodies which can be the basis for the next generation antibody-based therapeutics which are outside of the original Medarex contract.
Also some of the options we got for free, remember? That was because we gave Medarex shares in Genmab in 1999 when we founded the company.
I don't know, I don't remember whether for epcoritamab we owe any royalties for epco to Medarex, because it may have been one of the free slots which we actually don't have to pay any royalties on anymore. I will definitely check that. If that is public information, Peter, we will get back to you and others on that. I think that we still have some remaining slots under the original Medarex agreement, and I don't know whether we have used them or for all of the candidate therapeutics because the volume of new antibodies which are being created by Genmab goes up tremendously.
We have invested really significantly in building a stronger and stronger pipeline. I think that is what we need to do as an innovation powerhouse, which is very much science-focused. I can assure you that we're going to expand the clinical pipeline this year as well as in the coming years with novel candidates. Basically none of those molecules are traditional human antibodies from technologies like the Medarex transgenic mouse technology anymore.
They're all based on our new technology platforms, Peter. I think over 50% of our pipeline right now is based on the DuoBody technology, about 30% on the HexaBody technology. You will see new HexaBody molecules move into the clinic soon.
The remaining part of the pipeline is ADCs, and not only with toxic payloads, we also have now in our preclinical pipeline immune stimulatory ADC concept. We have never been more excited, Peter, on the pipeline. The exact answer on how many slots left, I don't have that here in front of me. Sorry.
That's great. Thank you very much, Gerard.
Thanks, Peter.
Thank you. Our next question comes from the line of Michael Schmidt at Guggenheim Securities. Please go ahead. Your line is open.
Hey, thanks for taking my question. I had a bigger picture question as well. Yeah, I guess to what degree does the outcome of the Janssen arbitration, in particular the ending of the DARZALEX royalty payments now in the U.S., at least in the late 2020s, to what degree does this, you know, clear visibility on that, perhaps impact your longer-term R&D strategy or does it impact your, you know, perhaps aggressiveness to move new projects forward or perhaps even your business development strategy longer term? Thanks so much.
Thanks, Michael, for the question. I can tell you it will have very minimal impact on our strategy because we are already having a very aggressive strategy. Epcoritamab will be an important swing factor, of course, in the early 2030s, Michael, to really keep the same growth, the compound annual growth rates. We are building up now with the very strongly increasing recurring revenue streams over the coming years until the early 2030s.
Dara is, of course, playing a key role in that. Also, we believe that we have the pipeline already which will allow us to accelerate some of the programs, like for example, the BioNTech partnered bispecific programs massively in the coming years.
That will be, as all models predict or long-range plans predict, Michael, we'll be able to fill up the hole, which is of course created by the loss of the income in time for daratumumab very well. Of course we will try to add other antibody programs and product programs to that as rapidly as we can. We will increase the number of INDs which we start per year in the coming years to keep filling that pipeline, because that has been one of the things, Michael, we have been unusually good at Genmab in creating very good therapeutic candidates.
I mean, we have, I think, an unparalleled hit rate in molecules we brought in the clinic and still actively clinically developing them alone or with our partners, of which over 50% of the molecules we ever brought into the clinic, Michael, are still in active clinical development, and 5 of these products are now on the market. Several of them are on the slate to become basically blockbusters or multi-blockbusters.
That is a really good, I think, hit rate. I think we are getting better now. I think we're going to see that the efficacy of bringing molecules through to products and which can really in a meaningful way impact the lives of patients.
I think we'll get better at that, not worse. I've never been more excited about the pipeline than I am today. I mean, we see amazing things, Michael, with the candidate products in the preclinical and early clinical pipeline. This year, we will share some of the data with you of some of the younger clinical programs. I think all of these could be used to basically continue the growth rate up, which is needed from the early 2030s on to the end 2030s. We're very excited, and I don't think the verdict of the arbitration will make any difference to that.
It has not slowed down our ambition level, I can tell you, to create a game change and potentially game changing products, Michael, but I think it has more. It has stimulated it actually from here.
All right. Thanks so much.
Thank you.
Thank you. Our next question comes from the line of Asthika Goonewardene of Truist Securities. Please go ahead. Your line is open.
Hey, guys. Thanks for taking my question. I kind of want to build on James Gordon's question a little bit here and maybe ask it in a different way. How confident are you that the data you have in hand right now can be the basis of a filing, and potential approval of epco? And then would this be in sort of a general all-comer third-line plus DLBCL population, or are you specifically gonna go after a subgroup like CART progressors? And then if I can also just be cheeky and add in, what can you tell us what the pre-specified efficacy threshold was for this, for this study? Thanks.
Hey, Asthika. Thanks for the questions. We need to be very careful until we have spoken with the regulators, as you know, to basically give you any further color on the confidence level. But what I can tell you is that we are super enthusiastic about the data ourselves, and we have also now discussed them with independent experts in the field. I mean, this is one of the most heavily pre-treated populations of large cell B-cell lymphoma patients.
There is actually no good comparative data. I think we need to await the interactions with the regulators, which have been scheduled now. I can tell you before I can give you any further color on the level of confidence, but internally that's very high.
The independent consultants are very, very enthusiastic about the data. This is I think unprecedented data, whether that will be good enough for filing in the different territories or some of the territories. I cannot tell you that right now. I can tell you what the exact indication is, which we will be seeking if the regulators are positive about the data. But we will let you know. I said already the top line data is released, and we will let you know once we have taken a decision.
Based on the feedback from the regulators, Asthika, we will let you know via press release what the next steps will be, and we are still very, very confident that we can actually go forward with a potential filing in the second half.
Not so much later than Roche and or Regeneron. I think this is going to be a pretty good competition, I think, in the coming years. We are very, very enthusiastic about moving into that competition and helping more and more patients. I think we're doing a good thing there, Asthika.
Thanks, Jan. About the pre-specified efficacy threshold.
We have not discussed that publicly because this is a heavily beaten up and pretreated population. We are going to share data sets with the regulators, but we have not done that publicly. We will do that after we have engaged with the regulators for sure.
Wonderful. Thanks for that.
Thanks, Asthika.
Thank you. Our next question comes from Xian Deng of Berenberg. Please go ahead. Your line is open.
Thank you. Thank you for taking my question. I actually have a question on DARZALEX, regarding the potential future competition. Now, the CAR T from J&J and Legend Biotech has been approved. They are actually doing a range of studies. I noticed one of the studies, CARTITUDE-4, is actually a study in second line onward patients, is actually looking to compare CARVYKTI versus DARZALEX combo, BPD.
I mean, I know this is, you know, CAR T and it's a different target, but given the trial design, I mean, if this trial is positive, then it means CARVYKTI is more efficacious than Dara combo. Just wondering, you know, do you think that could be a competitive threat to DARZALEX in the future?
Thanks for the question. I mean, no, we never know, of course. I think what Janssen is doing, they're very broadly developing different combinations in multiple myeloma. I heard yesterday, I was speaking with one of the Janssen colleagues, and they are super enthusiastic about the teclistamab, the molecule I already referred to, which has the same efficacy as some of the CAR T approaches. I can tell you that that will be combined with daratumumab. Also, CAR T is in some trials combined with daratumumab, and in other trials they run it against daratumumab to really see what the best regimen is.
Janssen is very actively now thinking about the sequencing, the order of the different therapies, because an anti-BCMA therapy one can only use once. Maybe it's good in the future to start with a CD38 therapy with daratumumab and then follow it up when the tumor relapses with a CAR T. I've not heard that there is any plans of replacing daratumumab. Most of the plans, I think over 80% of the trials right now are combinations with dara, not competition. I think they're properly exploring the area. I think what you should do is ask Peter Lebowicz from J&J what the long-term strategy is for J&J.
They seem to be pretty happy with daratumumab and how it's developing. It's the most successful heme product launch ever in history up to now from all products. So I think we couldn't be more pleased with how daratumumab is doing. And I think the perfect competitor to daratumumab we are developing right now ourselves, which is HexaBody-CD38. We have never seen a more potent molecule.
Yes, CAR T is effective, but it's also very, very laborious and expensive and certainly not ready for prime time in community healthcare centers and so on and so forth. The biggest markets will be for multiple myeloma, definitely in front line.
When you ask me, "Well, are you intimidated by them doing one of the trials?" Maybe one out of the 50 or so or 60 trials where CARVYKTI is being run against the dara. The answer is full-blown no. Absolutely not. I think it's good to explore. I think also J&J is a science-focused company, a data-driven company, and I think that's the thing to do. I think you should probably ask Peter Lebowicz or one of the other Janssen colleagues about their strategy there.
Thank you so much.
Thank you.
Thank you. Our next question comes from the line of Matthew Harrison at Morgan Stanley. Please go ahead. Your line is open.
Hi. Thanks for taking my question. This is Charlie Young for Matthew. For the 4-1BB combinations, can you just point out more clearly, I think do you still expect to present the data this year, or will they just be an update on the program and with data presentation in 2023? And maybe just in terms of kind of potential launch timing, like what will be the realistic expectation on when we can see, you know, if everything goes well, when can we see the product launch? Will that be in the 2024 or 2025 and beyond timing? Thank you.
Thank you for the question. I can assure you that both of the 4-1BB targeted bispecific programs are going very well. We have multiple cohorts that are actively recruiting patients as we speak. We believe that, for either the CD40 4-1BB or the PD-L1 4-1BB programs, we can actually take a decision in the coming, in this year, in the coming months to take them forward to late stage clinical development. We believe that we are in a position to share data for both programs, this year.
Whether that will be at a medical conference, we don't know because there's two things important. One is, the response rate and the depth of response, and then the second component is of course the duration of response.
We don't know how much duration data we will have for the different arms of these two bispecific programs. What I said publicly before is that we could potentially have a scenario that you see limited data from both of these programs this year and then full-blown data at a prestigious medical conference next year. That you will hear from us and BioNTech that we have already used the data which we have collected in-house to accelerate the program and move it to the next stage of clinical development. That is a realistic scenario that you will end up in that type of scenario.
It's a bit premature to discuss about the timeline for potential approval for either one of these programs, because a lot depends on where we will see the responses and in what line of treatment we will see the responses. Now with the new so-called FDA Project FrontRunner program, where the FDA is actually stimulating companies to move to frontline earlier on, we believe that definitely for the CD40x4-1BB program, we could potentially move to frontline in one of the cancers based on solid data, and then by hopefully being allowed to use surrogate endpoints have pretty quick readouts.
I think yeah let us come back after we get the data this year with some firmer estimates on the timelines.
I think the 2024, 2025 timeline sounds ambitious to me, but possible potentially in some of the cancers. When you ask me about our enthusiasm level, we are super enthusiastic about both bispecific programs, and we welcome the data this year, but maybe more extensive data next year in 2023. I hope that answers your questions.
Yes, that's super helpful. Thank you.
Thank you.
Thank you. Just as a reminder to participants, if you do wish to ask a question, please dial zero one on your telephone keypads now. We have one further one in the queue so far. That's from Yaron Werber at Cowen. Please go ahead. Your line is open.
Great. Thanks for taking my question. Jan, I have a question that's sort of interrelated, and it's two parts. The first one is, the Halozyme patents, or at least some of them in the U.S. expire in 2027, in Europe in 2024.
Do you have anything you can say as to what connotation, if any, does that have on your share of royalties, you know, on DARZALEX before the expiration of those patents? And then secondly, from a best commercial effort sort of clause in your relationship and your deal with Janssen, what their own patents on FASPRO obviously won't expire until 2036, so it gives them a long horizon to sort of get the next product approved. I imagine they need to be on some kind of a clock based on best commercial efforts.
I don't know if you can talk about that at all to expedite development to market. Thank you.
Yeah. These are two very sharp questions, Yaron. Thank you for joining the team, following us very actively. We're super pleased with that. As it relates to the Halozyme patents, I cannot give you any further information 'cause it basically boils down to the Janssen contract with Halozyme. I don't have any insight into that contract. It has been kept hidden from me. The lawyers have seen it, Yaron, and I think you need to ask J&J.
Also the best commercial effort question is probably a question for J&J. I probably cannot go into that 'cause then my lawyers will hit me after the call. I think I should probably refer you to J&J.
Anyhow, welcome to the team covering us, and we're really pleased and look forward to meet you soon in person. Now, we are living in a post-pandemic era at this time.
Awesome. Thank you. Thanks, Jan. Maybe I'll call your lawyer. I'm kidding, of course.
Very good. Maybe the J&J lawyers, then you probably get the answer there.
Thank you. Our next question comes from the line of Jonathan Chang at SVB Securities. Please go ahead. Your line is open.
Hi, guys. This is Faslon for Jonathan. Just wanted to ask, are we still expecting to see data in the second half for GEN3009 and GEN3014? Could you help set expectations for those data readouts?
3009 and 3014, that is the CD37 and CD38 programs, I think. Yes. You definitely will get data for both, for the dose escalation of the DuoHexaBody CD37 and for the HexaBody CD38 program. You will get data at a medical meeting from the dose escalation and probably for the CD37 program, hopefully some early data perhaps of the combination with epcoritamab, which preclinically synergizes greatly. For the HexaBody CD38 program, you will get data from the dose escalation and maybe some very early data from the head-to-head against subQ dara.
Great. Thank you.
Thank you. Our next question comes from Asthika Goonewardene of Truist Securities. Please go ahead. Your line is open.
Hey, guys. Two questions in one call. Love it. Jan, I traditionally ask you about GEN1046 and 1042, but let me get back to that. Talk to us a little bit about the development strategy here of these two assets. Do you see much of a overlap between these two, or are you looking to develop these in some very unique indications? Can you maybe talk to us a little bit more about the FDA's interest for pushing companies going to the front line setting a little bit more? I think we need to appreciate that a little bit more here with these two assets. Thanks.
Thanks, Asthika. Let me talk about ten forty-two and ten forty-six. It's too early. We don't know basically whether we can position both of these bispecifics into different indications. Right now, we are testing different combinations. As you know, we are doing frontline melanoma, lung cancer, head and neck cancer, pancreatic cancer with ten forty-two, either together with Pembro or Pembro plus chemo in these different settings.
For ten forty-six, I think we have now 12 cohorts in different tumors, I think six or seven different tumors, where we also combine some of the cohorts, ten forty-six with Pembro. And then other cohorts, ten forty-six with chemo, with Taxotere.
It's a bit too early, I think, to talk about positioning, but what we see is a difference in safety profile. 1042 seems to be a bit cleaner than 1046. We believe that they may in the end both find a place, Asthika, for use in solid cancer therapy. We are actually very excited, and I think we have done more with 1046 up to now and 1042 and what we learned about biomarkers and what was needed in order to get good and solid responses which are durable.
I think this year will be the year of truth that we can actually get a good idea about positioning of these molecules and then move it further from there. Your second question is on the FDA FrontRunner program, which was only introduced a few weeks ago. This is a program from the FDA, where the FDA basically says, "Well, we really don't want to use accelerated approvals in the future so much for like really end-stage patients with diseases like cancer with which have no other treatment options anymore.
We think it's actually more valuable and more impactful for patients to move to frontline treatment of these patients.
We will help the sponsor by not asking for the traditional frontline endpoints, Asthika, like a PFS or overall survival. Because in some cancers, the time that you need to wait to reach the endpoints are so long that it is simply not practical to move to frontline therapy. We will help the sponsors by using surrogate endpoints, which can be molecular endpoints like MRD or other surrogate endpoints, depending on which tumor one is studying, so that you can actually come quicker to a readout. Then it needs to be a control arm-based study.
Genmab right now has the financial robustness, Asthika, that with good early data from the ongoing studies, we could actually potentially engage with the regulator like the FDA and move forward under the Project FrontRunner program if they would allow us to frontline patients, which, of course, is where the market is much bigger and where we can be much more impactful to the lives of patients. We are actually super excited, and we are thinking of that in the context of GEN1042, GEN1046, but also of course for epcoritamab, because we have started later than Roche in some of the areas.
This could be an excellent molecule also to move under the Project FrontRunner program to actually penetrate frontline settings much more quickly.
We are very excited, I can tell you, about the new way of thinking of the regulator. I think it's the right thinking. We think that Genmab is the perfect company to actually use that type of program. There's of course the other program which I've spoken about at the full-year results in February, the Optimus program, which is requiring more dosing iterations, which is certainly going to be asked from Genmab as well as from all other companies in the oncology area.
Under the rationale that perhaps in some combinations one could use a lower dose of the therapeutic candidates than what is used in monotherapy, Asthika.
That could, of course, slow down a bit the development unless you agree with the regulator to do multiple arm studies. Genmab is now in a position with a better pipeline than we ever had before, a better team than we ever had before in our history, and a robust cash position to do actually multiple arm studies, also under the Project Optimus program, to actually very quickly titrate and obtain the optimal doses of new therapeutic antibody candidates. Yeah, we are very busy.
I can assure you that it may sound silent around Genmab, but we are like buzzing like never before in our history with better molecules than we ever had before in our history, Asthika.
This year there will be a firework, I can tell you, at all levels here from our side.
Thanks, Jan. Appreciate it.
Thank you.
Thank you. We have one final question. That's from the line of Matthew Harrison, Morgan Stanley. Please go ahead. Your line is open.
Hi, it's Charlie Young for Matthew. Maybe just if you can tell us a little bit more about the B7H4 molecule and how do you see this bispecific compete with the current ADC in development and whether you're looking at the other kind of B7 targets such as B7-H3. Maybe if I can squeeze in on one last one. Can you just reiterate the 2025 vision? Are there any kind of financial guidance that you have in mind, or maybe other metrics that you could point us to? Thank you.
Thank you, Charlie, for the question. The B7H4 molecule is a super potent bispecific, a CD3 engaging bispecific. B7H4 is very attractive as a target. Preclinically, it's very selectively expressed on cancers, on a number of cancers, so we are doing a whole group of cancers now. It's all overexpressing B7H4. In dose escalation, we are doing that as we speak.
I can tell you that preclinically, we have compared our CD3 bispecific with a number of other approaches, including ADC approaches, and this one was always the more potent molecule. We don't know yet, Charlie, whether this is going to be reflected in better potency in the clinic, but we are highly encouraged by what we see preclinically.
I think we will come this year again at conferences with more preclinical models and to basically show you the underlying data for our enthusiasm for this molecule. I think next year you will get probably the dose escalation data from the CD3 B7H4 program. We are very, very enthusiastic. We are also looking at other family members. I can tell you preclinically, Charlie, but we have not yet presented any data from other family members of B7H4.
We are looking broader at a family of targets, 'cause it's very difficult, as you and I know, to find really truly tumor-selective and tumor-specific targets for solid cancers, and I think this is one of the really, really good ones. I think it's preclinically differentiates quite nicely from other approaches. As it relates to our 2025 vision, we are well on track, I think, to actually reach that vision. We have never had a better pipeline than we have right now.
It's all based on the next-generation antibody technologies. We have already, of course, one product on the market together with Seagen, Tivdak, which is doing well. It's well received. Doctors are really positive and about the molecule.
It's very, very potent and straightforward to work with. We are pleased with how the early launch is going for Tivdak. Hopefully we will add epcoritamab next year to that clinical product pipeline which we own together with AbbVie. We have never been more enthusiastic about any molecule than about epco. I think this is potentially a very, very good medicine. We're well on track, I can tell you, to really hit our vision, reach our vision by 2025.
I can tell you very soon, we start speaking about our 2030 vision, where we hope to actually make an even more impactful impact on the lives of patients, cancer patients and perhaps even patients outside of cancer. 'Cause some of our products are being used now like TEPEZZA in thyroid eye disease and of course Kesimpta in relapsing MS. We are going to make a bigger and bigger impact on the lives of patients with our products. I think we're gearing up towards the 2030 vision. 2025, we're well on track.
Hopefully we can get our second product, which we own 50% or more on the markets, by next year, so we can actually build a very solid market for treatment of patients.
Thank you.
Thank you.
Thank you. As there are no further questions at this time, I'll hand the floor back to our speakers for the closing comments.
Thank you all for calling in today to discuss Genmab's financial results for the first quarter of 2022. If you have any additional questions, please, do not hesitate to reach out to our investor relations team. We hope that you all stay safe, remain healthy and optimistic, and very much look forward to speaking with all of you again soon.
This now concludes the conference. Thank you all very much for attending. You may now disconnect your lines.