Genmab A/S Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 2, 2024

There are 15 speakers on the call.

Operator

Hello, and welcome to the Genmab First Quarter 2024 Conference Call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward looking statements that include words such as believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delays or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future nor to confirm such statements in relation to actual results unless this is required by law.

Operator

Please also note that Genmab may hold your personal data as indicated by you as part of our Investor Relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. I would now like to hand the conference over to your first speaker today, Jan van der Winkle. Please go ahead.

Speaker 1

Hello, and welcome to Genmab's conference call to discuss the company's financial results for the period ending March 31, 2024. With me today to present these results is our CFO, Anthony Pagano and our Chief Operating Officer, Anthony Monsigni. For the Q and A, we will be joined by our Chief Medical Officer, Tay Yamadi and Chief Development Officer, Judith Klimovsky. As already said, we will be making forward looking statements. So please keep that in mind as we go through this call.

Speaker 1

During today's presentation, we will reference products being developed under some of our strategic collaborations, and this slide acknowledges those relationships. Before we look at our Q1 results, I want to remind you of our consistent track record of success. Our proprietary technologies fuel our robust product pipeline, which is both expanding and maturing. And our growing revenue streams allow us to continue to invest in our people and in our pipeline. These are investments that will further accelerate our evolution into a fully integrated biotech innovation powerhouse.

Speaker 1

In addition to our existing technologies and mid to late stage pipeline, a key investment that will enhance our long term growth profile is the exciting proposed acquisition of Profound Bio. So let us turn to that briefly now. The proposed acquisition of ProFound Bio firmly aligns with our core vision and strategy of transforming the lives of people with cancer and other serious diseases. It is highly complementary to our business and the addition of Perform Bio's next generation ADCs, including Ryna S plus its novel ADC technology will further strengthen our already very strong and innovative mid to late stage clinical pipeline. This will also strengthen and accelerate our capabilities in the ADC space, in addition to helping to propel us towards a 100% owned model with more value captured.

Speaker 1

So we are investing to unlock meaningful value by the end of the decade with significant upside into the 2030s. We expect to close the acquisition in the first half of twenty twenty four, subject to the receipt of regulatory clearances. So now let us turn to other important recent events. Aperitimab continues to receive regulatory approvals in relapsed or refractory diffuse large B cell lymphoma in various territories with additional filings underway. We and our partner AbbVie have a robust development plan for epegaritumab and in the Q1 of the year, we took significant steps to move into follicular lymphoma.

Speaker 1

In March, we along with AbbVie initiated the first of multiple Phase 3 trials anticipated to start this year. Abcuritumab in combination with rituximab and lenalidomide for the treatment of patients with previously untreated follicular lymphoma. Looking at relapsed or refractory follicular lymphoma, in addition to the JNDA submission in Japan, the FDA granted priority review to a supplemental biologics license application for Abkinli as a treatment for relapsed or refractory follicular lymphoma following at least 2 prior lines of therapy with a PDUFA date of June 28. If approved, Abkinli will be the 1st and only subcutaneous bispecific antibody approved to treat this indication. And these were not the only regulatory events.

Speaker 1

Excitingly, the FDA has now approved the supplemental biologics license application for TifDAC for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. And this converts the 2021 accelerated approval of TIVDAC to a full approval, making TIVDAC the 1st ADC with demonstrated overall survival data to be granted full approval in this patient population. This approval represents a significant achievement for women with recurrent or metastatic and metastatic cervical cancer as it reinforces TIVDAC as a survival extending treatment option in patients whose disease has advanced after initial treatments. In addition to this approval, I'm very excited to share that at the end of April, we filed a JNDA requesting approval for TIVTAC for patients with advanced or recurrent cervical cancer in Japan. And this is excellent news for patients in Japan in need of this potential therapy and a milestone for Genmab as we continue to build our presence in Japan.

Speaker 1

I would like to thank the patients and investigators who took part in the clinical trials that form the basis of the U. S. Approval and Japanese submission, our partners at Pfizer for their collaboration and the passionate and determined teams at Genmab whose hard work and commitments made these events possible. Before moving on, I would also like to note that we were very pleased to hear that in March, Tivtek was added to the NCCN Clinical Practice Guidelines in Oncology for vaginal vaginal cancer under other recommended regimens. In the Q1, there were several data presentations across our programs, including an oral presentation for Tivtek at the SGO Annual Meeting on Women's Cancer and presentations for Abkinli at conferences, including the Annual Meeting of the Japanese Society of Medical Oncology and the AACR Annual Meeting.

Speaker 1

We are also looking forward to multiple upcoming data presentations at ASCO. These include 2 rapid oral presentations for Abkinley of new data in both relapsed or refractory and untreated follicular lymphoma, a rapid oral presentation on TIVDAC in head and neck cancer and a poster presentation for acasunlimab or GAN1046 in second line non small cell lung cancer. And this is of course the data that we and our partner BioNTech anticipated presenting in the first half of this year. And we are currently engaging with health authorities on the design of a pivotal trial in this patient population with an aim to start this trial in late 2024. Finally, turning to medicines powered by our innovation.

Speaker 1

In March, Janssen announced that the FDA approved Ribofant in combination with chemotherapy for the first line treatment of patients with non small cell lung cancer with EGFR exon 20 insertion mutations, converting the May 2021 accelerated approval to a full approval. In addition, in Q1, Janssen submitted applications for approval in both the U. S. And Europe for subcutaneous daratumumab based on data from the Phase 3 PERSEYS study. I'm pleased to now hand over the call to Anthony Monsigni to take you through our Q1 2024 net product sales, including for DARZALEX.

Speaker 1

Anthony, the floor is yours.

Speaker 2

Thank you, Jan. In Q1, product performance across our 2 key revenue streams, Royalty Medicines and Genmab Commercialized Medicines showed very strong growth. Our portfolio includes 6 royalty medicines DARZALEX, COSIMTA, TEPEZZA, TEGVYLE, RIBRUVANT and TALVAY. DARZALEX demonstrated strong demand growth in Q1 with just under US2.7 billion dollars in net sales, a 19% year over year growth driven predominantly from share gains in frontline multiple myeloma. With the recent filing of Perseus, there are continued growth opportunities ahead with DARZALEX subcutaneous based therapies in the frontline transplant eligible multiple myeloma space, including maintenance.

Speaker 2

DARZALEX is also being combined with both newer and older therapies in multiple myeloma, including with 2 of our recently approved dual body medicines, tekvyle and talve. We expect continued growth and use of DARZALEX as a backbone in later line settings as well. Casympta achieved continued strong demand growth with $637,000,000 in Q1, a 66% year on year growth. COSYMTA demand growth is not only progressing well in the United States, but also outside the United States. It continues to be the new to brand share leader in 7 of 10 major markets outside the U.

Speaker 2

S. The performance across our other recently launched royalty medicines, TEGFILI, TALVAY and RIBRUVENT, all bispecifics based on our dual body technology, each delivered strong growth in the quarter. The TEGFILI launch is continuing to go very well and delivered $133,000,000 in the quarter with strong uptake and rapid adoption in the U. S. And other key markets, reflecting a best in class off the shelf BCMA bispecific therapy that's offering deep and durable responses in relapsed or refractory multiple myeloma.

Speaker 2

We expect to see continued strong Genmab revenue growth from our diverse royalty medicines portfolio in 2024 and beyond. Turning to our Genmab commercialized medicines on Slide 8, Abkinley delivered US54 $1,000,000 in net sales for Q1, with over 90% coming from strong launch performance in both the U. S. And Japan. We are very pleased with the Abkinley launch performance across geographies.

Speaker 2

In the U. S, we continue to see robust uptake across key accounts. Abkinley was launched in Japan late last year and we're highly encouraged by the early launch uptake and overall positive response from our customers there. Epkinley is the 1st and only approved bispecific antibody in the U. S, the EU and Japan for patients with 3rd line plus diffuse large B cell lymphoma.

Speaker 2

And we are preparing for potential approvals for Fkenley in 3rd line plus follicular lymphoma with U. S. PDUFA date of June 28. We're also pleased to announce that earlier this week, the NCCN has included Epkinley monotherapy as a preferred regimen with a 2A designation in follicular lymphoma after 2 prior lines of therapy. Our first indication in 3rd line plus DLBCL, an area of significant unmet need is the first step to establishing at Kinley as the core therapy across B cell malignancies, including follicular lymphoma and in earlier lines of treatment.

Speaker 2

TIVDAC delivered $27,000,000 in net sales for Q1, representing the 10th consecutive quarter of demand growth. We're pleased with Tivdaq's performance, which was primarily driven by an increasing breadth of ordering accounts. Gynomp and MedOnc customers continue to provide positive feedback on the impact TIDDAC is making on the lives of women with cervical cancer. As Jan mentioned, the Japan new drug application for TIVDAC was submitted in late April. And the FDA approval on April 29 based on the innovative 301 study, which demonstrated a 30% improvement in overall survival and a 33% improvement in progression free survival will help establish TIVDAC as the clear standard of care in second line plus recurrent or metastatic cervical cancer.

Speaker 2

We're enthusiastic about the proposed acquisition of ProFound Bio, whose lead asset RENA S is a potential best in class ADC in ovarian cancer that would add a second ADC in gynecologic oncology to our portfolio in addition to TypDAC. As an end to end biotech company, we're very pleased with the performance of our Genmab commercialized medicines and look forward to carrying this momentum through 2024 and beyond. Thanks to our partners and thanks to the entire cross functional Genmab team for all they do every day to deliver for the patients we serve. With that, let me hand it off to Anthony Pagano to provide additional perspective on our Q1 financials. Anthony?

Speaker 3

Great. Thanks, Anthony. We continue to strengthen our foundation in Q1. Having reached our goal of successful regulatory approvals and launches for Abkinley in the U. S, Europe and Japan in 2023, we are pleased with how the launches are progressing into Q1.

Speaker 3

Now we're looking forward to the potential for additional approvals in these territories for late line follicular lymphoma and continuing to expand and accelerate EPCOR's clinical development. And as we'll see, our financials remain strong. Recurring revenues grew by 42% in Q1. This was principally driven by strong royalties from DARZALEX, KASIMTA and other approved medicines, as well as net product sales for Epkinley. 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.

Speaker 3

And an important part of this has been to continue to build the team and capabilities that we need to succeed. So let's take a look at those revenues in a bit more detail. We grew total revenue to over DKK 4,100,000,000 in Q1. And as I've already highlighted, that included a 42% increase in our recurring revenue. This strong growth was driven by higher DARZALEX and KASIMTA royalties as well as royalties from other products.

Speaker 3

And we're really pleased with how Epkinley and TIVDAC are performing. Taken together, these two products contributed 27% of the total growth in revenue that we realized in Q1. And this really illustrates the power of our recurring revenue. And overall, this strong recurring revenue growth enables our continued highly focused investment as you can see on the next slide. In line with our significant growth opportunities, total OpEx grew 31% in Q1.

Speaker 3

In R and D, we've accelerated our investment into our product portfolio, especially the advancement of our mid to late stage pipeline. Here, we're expanding the development for Epkinley, DIVDAC, Gen1046 and Gen1042. And we continue to invest to secure a successful epkinley launch in our 2 key markets, the U. S. And Japan.

Speaker 3

Now let's take a look at our financials as a whole. Here you can see our summary P and L for Q1. Revenue came in at over DKK 4,100,000,000 and that's up 46% on last year. Total expenses were just under $3,200,000,000 with 73% being R and D and 27% SG and A. And even with the increased investment, we're still delivering over DKK 800,000,000 of operating profit and that's up more than 90%.

Speaker 3

Moving now to our net financial items. Here we have a gain of DKK915,000,000. This gain was driven by the strengthening of the dollar against the kroner in Q1 as well as by an increase in interest income. Then we have tax expense of just over $390,000,000 which equates to an effective tax rate of 22.8%. And that brings us to our net profit of over DKK 1,300,000,000.

Speaker 3

So as you can see, continued strong underlying financial performance. With that, let's take a minute to revisit our robust financial framework. First off, our revenue profile on the left. There are now 8 products in the market that are generating recurring revenues for us. 3 of these are already blockbusters and the remaining 5 all have significant potential for future revenue growth.

Speaker 3

So for this year, we're anticipating 25% recurring revenue growth at the midpoint 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. And at the top of the list is accelerating and expanding EPCOR. But that's just one of the exciting opportunities that provide us with a compelling rationale for investing back into our business.

Speaker 3

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 the Phase 3 trials, we anticipate we'll start in 2024. And on top of this, we also have the proposed acquisition of Profound Bio, including its most advanced program, RENA S. RENA S is potentially best in class and registration trial ready.

Speaker 3

We anticipate the first potential approval for RENA S in 2027 and importantly, we are anticipating blockbuster peak sales potential. So with that background, let's now take a look at our guidance. Here you can see our existing guidance which we announced in February. We're currently on track to meet these financial targets excluding the impact of the proposed ProFound Bio acquisition and related deal costs. We continue to anticipate strong growth in revenue for 20.24 of 19% at the midpoint, driven by both our royalty medicines and importantly we anticipate that we will have over DKK 1,200,000,000 of growth from Epkinley and TIVDAC.

Speaker 3

In fact, Ept Kinley and TivDak are driving nearly 40% of our total revenue growth in 2024. Now as I told you back in April, we anticipate that the proposed acquisition of Profound Bio will impact our guidance. Pending closing of the deal, OpEx before transaction expenses are now anticipated to be at or moderately above the upper end of the guidance range of DKK 12,400,000,000 to DKK 13,400,000,000. The anticipated increase reflects the incremental R and D investment to support the advancement of ProFound Bio's clinical programs primarily RENA S. This potential incremental investment is fully in line with our previously communicated priority of increasingly focusing our investment on mid to late stage R and D programs with high potential.

Speaker 3

And finally, as a reminder, we plan to update our overall guidance no later than our Q2 2024 earnings. Now let me provide a few closing remarks. In summary, we've had a very solid start to the year. We have growing recurring revenue streams increasingly from our proprietary products 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.

Speaker 3

And on that note, I'm going to hand you back over to Jan.

Speaker 1

Thanks, Anthony. Let's move to our final slide. Over the past few months, we have made significant progress towards our 2024 goals. Especially for Abkenley, we made strides towards both goals you see here with the initiation of a new Phase 3 trial, as well as priority review from the FDA for relapsed or refractory follicular lymphoma. We look forward to the PDUFA date and potential approval of this new indication in June.

Speaker 1

And of course, we are extremely pleased with the recent approval for TIVDAC. We are also very much looking forward to presenting the Phase 2 acasunlimab data at ASCO next month. We continue to have a lot to look forward to in 2024 and we look forward to providing you with additional updates. That ends our presentation of Genmab's financial results for the Q1 of 2024. Operator, please open the call for questions.

Speaker 4

Thank

Operator

We will take our first question. And your first question comes from the line of James Gordon. Please go ahead. Your line is open.

Speaker 1

Maybe move on to the next one, operator, and then take James back when he is back online.

Operator

Of course. Yes, of course. Please stand by. The next question comes from the line of Sachin Jain.

Speaker 5

Two pipeline questions, if I may. Firstly, just post recent FDA adcom on MRD negativity in first line myeloma, just I wondered on your headline thoughts as to how that may change development and whether you sense any shift in J and J as well this is a key decision metric for them as part of the HexaBody decision expected end of this year, early into next year. And then secondly on 1046, just two quick questions. 1 at ASCO, should we be thinking about potential OS data in addition to the PFS you flagged before? And then on the Phase III trial design discussions with regulators, just wondering if that's taking a little bit longer than expected.

Speaker 5

And are there any specific aspects of the design that is holding us up at this moment? Thank you.

Speaker 1

Thanks, Sachin, for the questions. I think I'm going to hand over both of the questions to Tahi and then maybe Judith can add to that. Tahi, why don't you start with the MOD negative molecular endpoints?

Speaker 4

Sure. Thank you for the question. So the first question, M ID negative, I think the reaction generally to this is that this is a good thing for patients with multiple myeloma because it frankly allows the opportunity to the development of novel mechanisms in frontline, which otherwise would have been extremely challenging. And I think as it relates to J and J, they also, in their own call, recognized the opportunity that MRD negativity as a surrogate endpoint provides for the development of novel mechanisms in multiple myeloma. I think we can leave it at that.

Speaker 4

As it relates to 1046, where we actually had all of our health authority interactions. So we met with the FDA, European and Japanese health authorities and have gotten the feedback in the corporate meeting as we speak and are continually operationalizing towards activating the study by the end of the year. So there's nothing really to hold up. Your other question is around the specifics of the abstract. We've done this many times.

Speaker 4

I tried to avoid getting into the details of the abstract or the presentation. But I would again emphasize that OS is the appropriate endpoint in that space and of course an important data point, probably the most important data point in the decision making process for us.

Speaker 1

Thanks, Thijs. I think Sachin, we probably need to keep it to that.

Speaker 5

Perfect, Nick. Thanks very much.

Speaker 1

Thanks, Sachin, for the questions. So maybe, operator, let's see whether we can get James Gordon back.

Operator

One moment, please. At the moment, he's not in the queue. Are you happy to move to the next question?

Speaker 1

Absolutely. Operator, please move on to the next one. He may have lost the line.

Operator

Of course. Your next question comes from the line of Vikram Parrajit. Please go ahead. Your line is open.

Speaker 6

Hi. Thank you for taking our questions. So we had 2, 1 on Gen 30, 14 and then one on just your thoughts on business development broadly. So on 3,014, just wanted to see if there's any updated thoughts from your side on timelines to the next data update and then also how much of a time lapse there may be between the release of the data and the potential decision from J and J regarding potential next steps? And then on business development, moving forward, how are you thinking about prioritizing between opportunities in oncology and potential efforts in immunology?

Speaker 6

Thank you.

Speaker 1

Thanks for the question. So I will pass the first one to Tai. So let me start with the second one on BD. I mean, we are going to be very, very focused on oncology. I mean, currently, the dominant focus is on oncology.

Speaker 1

And priority 1 is to actually, as it relates to the opportunities, is closing Perfon Bio acquisition that we hope to do after getting the regulatory clearance in the coming months and then integrate and execute the development plan for RINA S. And then beyond that, we continue to look for opportunities such as bringing in tools and components for the R and D engine. And oncology is getting a lot of attention, but also INI, because we are increasingly also looking at immunology and inflammation. But the dominant focus is oncology for the time being. So let me move to TAI now for the JEN-three thousand 14 data and the decision timing for JNGA Ty?

Speaker 4

Yes. I think on this particular question, I think we have been very clear and consistent. There's a pre agreed data set with J and J that includes a number of patients and the number of months follow-up for these patients. And also have in previous calls repeatedly reiterated that the there's a predefined time window and that is relatively confined for J and J to make that decision. And if you take this all together, you can imagine that we said we are continuing to operationalize towards providing that data by the end of the year.

Speaker 4

And the time window probably between that data becoming public then and the decision is not that long. I should probably leave it at that. I don't think we can be more specific about this, but it's a very clearly laid out timetable potentially.

Speaker 1

Thanks, Thijs. Thanks, Thijs. Thanks, Fikram, for the questions. So let's move back to the operator.

Operator

Thank you. We will take our next question. Your next question comes from the line of Zaiyan Deng. Please go ahead. Your line is open.

Speaker 7

Hi. Could you hear me all right?

Speaker 1

Yes, we can hear you.

Speaker 7

Yes, perfect. Yes, three questions please, if I may, all on 1046 please. The first one is, your data so far on liver tox seems to be quite manageable, but just wondering what are your thoughts on the long term safety profile on that side, any potential for accumulated liver tox for the patient who use it for longer? Have you seen any accumulated sort of liver tox data? That's the first one.

Speaker 7

And the second question is, so just wondering, I mean, understand the 1046 for ASCO, this is a poster presentation, not an oral presentation. So just wondering whether it's possible to disclose the data cutoff for the abstract you submitted and what is the data cutoff roughly for the actual data to be presented, please? Just wondering whether the data has evolved a lot since that. And then the third one is, given the feedback you had from the FDA on Phase III trial design, just wondering whether you could disclose that you will focus on PD-one positive only or it's going to be more defined such as PD-one high only? Thank you.

Speaker 1

Thanks, Dion. These are very good questions. I will again hand them over to Thijs and maybe Judith can step in there. Tai on Levitox maybe to start off with. Kai, are you there?

Speaker 4

Yes, I was on mute.

Operator

Hi, Kai. Yes.

Speaker 4

Thank you for the question. On Libertox, you're absolutely correct, and we have now a substantial amount of experience with the asset also in combination with PD-one and also a decent follow-up. It seems manageable in our hands. Patients can get re exposed after a recovery period. And broadly speaking, tolerate re exposure really well, and we have absolutely no evidence with accumulation of liver toxicity with a, as I said, substantial amount of patients across many trials with a relatively long follow-up?

Speaker 4

So that was the first question. The second question was on cutoffs. I'm not really going to go into the specifics, but as previous calls already indicated that there is a cutoff used for the abstract and then there is an updated more timely cut off use for the presentation. So there will be updated data at the presentation. There is more follow-up, obviously, and more data as in the abstract.

Speaker 4

And then the last question was on the trial design of the population, and I think we've also been very clear on this. The intent is and then there's nothing changed on this, to explore the combination of 1046 plus pembo in control against the current standard of care which is foslitaxel in patients who are PD L1 positive. And PD L1 positivity here predominantly is necessary because the drug is PD L1-four MB and it requires PD L1 tumor cells activate formulb on T cells.

Speaker 1

Thank you, Thijs. Very clear. Thanks, Ion. Let's move on to the next operator.

Operator

Of course. Please stand by. Your next question comes from the line of Edsard Dalot. Please go ahead. Your line is open.

Speaker 8

Thanks. Thank you for taking the question. Just a couple of questions, if you can, on sort of Phase III design. 1st around TIVDAC and head and neck, your sort of thoughts around sort of the patient population control arm for that study as well as sort of your sort of expectations around sort of the initial indication for RINA S for the 2027 potential launch that you highlight in terms of sort of what population you would go into there and sort of the line of treatment as well? Just a little bit more color on those Phase 2 designs, if you can.

Speaker 8

Thank you.

Speaker 1

Thanks, Edsall, for the question. So Judith, why don't you take the first one on head and neck design for Phase III for TIVDAC? And then Tay can potentially give a bit more color on the RINOS first trial. We hope to actually put into place several trials, but the one leading to a potential 2027 initial approval. Judith, maybe you can start.

Speaker 9

Yes. So with the Phase III, we're engaging with health authorities as we speak to finalize the details of the study design. But it's based on the initial data presented at ASTRO and the updated data that will be present in an oral this year at ASCO. So more to come. So but the population that we presented at Aptro consistent what we will present is second, third line after checkpoint inhibitors, platinum and we allow for cetuximab as well.

Speaker 9

And as you know, the 3 of them are given almost in the majority of the industry in ASTRO. And with regard to the Phase III design, more to come based on the interactions that we are currently having.

Speaker 1

Thanks, Judith. And then maybe we can move to Rainer S and then maybe, Tai, you can start and then potentially, Judith, you can add to that. Tai?

Speaker 4

Yes. I want to be very careful what I'm going to say because we're still in the HRS period. And so I'm going to stay with what Perfon Bio has publicly already stated on their end, which is that they are planning to initiate a Phase III in PROC and that they are planning to initiate a study that looks at folate receptor expression across the spectrum.

Speaker 1

Thanks, Tayo. I think that's very wise to stay on the right side of the line because we still need regulatory clearance for that proposed acquisition. Could probably, absolutely not be further detailed at this moment. We will do that after we hopefully execute successfully.

Speaker 8

I appreciate the color. Thank you.

Speaker 1

Thanks. Thanks. Let's move on to the next analyst.

Operator

Thank you. Your next question comes from the line of Yaron Werber. Please go ahead. Your line is open.

Speaker 10

Hi. This is Jaina on for Yaron. I have 2, 1 on DARZALEX and 1 on McKinley. You mentioned on the call that DARZALEX you expected to continue to have some presence in the relapsed refractory setting. Can you actually give us a breakdown of DARZALEX share across lines of therapy?

Speaker 10

And then for Akkinley, how are you thinking about Akkinley's advantage of kind of subcutaneous administration versus Columbia's advantage of fixed duration dosing? And do you think that Akinley is also going to have fixed duration dosing over time? Thank you.

Speaker 1

Thanks very much for the questions. And Anthony Montsilicon, I think, best go into the first question and then Thijs can give further color on subcu of Abkinli and then fixed duration of dosing in newer studies? Maybe Anthony Molcini, you can start.

Speaker 2

Yes. So thanks for the question. I'll just start by summarizing what I said earlier, which is the DARZALEX share gains are really driven by frontline continued growth in frontline. So if you look at the frontline new patient share, it's now 53%, which is a over 14% absolute growth versus same time last year, which is really the key driver. And I would just the other key number is overall DARZALEX patient share was about 43%.

Speaker 2

This is based on IQVIA Brand Impact Rx data. And the new patient share overall is exceeding the total patient share with a year on year 4 point uptake versus last year on an absolute basis. So we continue to see that leading indicator being really important to predict continued growth of DARZALEX. Front line and second line were where the majority of the growth came and at the expense of 3rd and 4th line. I think I'll leave it there and pass it to Tahit to talk a little bit about the duration.

Speaker 2

I'm happy to add in on that one too. Tahit?

Speaker 4

Yes, sure. So I'll take the first question and then also answer the second question. So generally, I think this discussion, this messaging around duration of treatment is a very academic one in my mind. As you noted, in combination, Epkine will also be given an FX duration that is because in combination, the efficacy is, of course, enhanced and the CR rates are higher. So potential to achieve long term durable emissions is higher.

Speaker 4

I would say like the final judgment on whether it is wise to stop treatment in the relapsedrefractory setting with a single agent will probably come from the updated longer term follow-up data and then people can cross compare. Anyhow, they can stop if they would like so, but they can probably not start if they are forced to stop by label. So that's my first thing. I think this is a less of an important differentiator, frankly, as you can hear from my commentary, than IV versus subcu because fundamentally the subcu route together with the also optimized safety profile gives us the opportunity to reach the patients with the different health care settings than Colombia with this IV administration.

Speaker 1

Thanks, Tayo. Maybe you can give a bit more color on the more recent studies in earlier lines of treatments where we don't use fixed where we also use a fixed duration. Yes. So

Speaker 4

all APCO studies that are in combination, either in the Fusas B cell or in follicular lymphoma, in combination have a fixed duration treatment. And that, as I kind of alluded to in the earlier commentary, is a function of our belief that in combination, we have seen increased significantly in times increased CR rates. And this is fundamentally all about CR. The durability of the remission, which is driven by the CR, the potential to give these patients the benefit of a very long, sometimes maybe possibly a curative response to Abkinje is significantly enhanced when it comes in combination. And then it makes sense to think about stopping treatment vis a vis as a monotherapy, at least in the refractory to FUZAZBIZA setting.

Speaker 1

Thanks, Thijs. I think that should be hopefully, it's clear now, Janna.

Speaker 11

Yes. Thank you.

Speaker 1

All right. Thanks. Let's move on to the next.

Operator

Thank you. Your next question comes from the line of Athisa Gounvardhane.

Speaker 12

So I've got a couple on McKinley please. How much of your sales are coming from academic centers versus community? And then are you getting any pushback from the community practitioners about having to send the patient to the academic center to get to be admitted for the monitoring required on just the one dose. Related to that, how are things going with the outpatient study? I'm wondering when we could see that data presented and perhaps filed.

Speaker 12

And then if I can sneak one in on 1046 on the pivotal trial design that you discussed with regulators, I'm wondering if you had any differential dosing of 1046 based on PD L1 status, maybe in the 1% to 49% if you were dosing at a different rate versus patients who had about 50% PD L1 expression? Thank you.

Speaker 1

Thanks, Asthika for the question. So the first two, I think I want to hand over to Anthony Montini, then Thij can address the last one. Anthony?

Speaker 2

Yes. Thanks, Asthika, for the question. So I think it's a great question, academic versus community. I think in the earlier part of our launch, we really had a focus on new starts that were heavily pretreated, patients were being treated that was really largely academic focused. We've started to see in recent months now that there's been a modest shift beyond the major academic centers.

Speaker 2

Of course, our key accounts are primarily major research institutions and health systems that have CAR T capabilities. So we have seen a shift of late beyond major academic centers and we're encouraged by our ability to get to broader sites of care and we've now seen large physician group practices starting to use at Kinley, but it's at the early stages, Asthika, at this point in the community. Of course, that's a U. S. Dynamic.

Speaker 2

In Japan, it's really a hospital based dynamic overall. But I think this will continue to evolve over time. And as data evolves with outpatient data, as you mentioned and optimization data both in DLBCL and FL, I think we'll start to see more large physician group practices start to use McKinley in a greater way. But again, this is the shift. And with that, maybe I'll pass it to Tahi to talk about the next 1046 design question.

Speaker 1

And maybe Tahi can start with the status of the outpatient study, the Phase 2 out patient study. That's one of the questions from Asthika. Any update, Tay, on the status of that Phase II study?

Speaker 4

Well, I mean, it's occurring quite well. And I think there are also plans to present some of the data towards the end of the year, but that's probably all I can say. It's ALFI runs for the actually. So that's all there is. And on 1046, what a simple question is no answer is no.

Speaker 4

So one dose, one schedule, regardless of the PDI-one status. Also not entirely sure if I would understand how that would work with the bispecific that once they engage for maybe a simple answer, one dose, one schedule.

Speaker 1

All right. Thanks. All right. Thanks, Vasika, for the question.

Operator

Thank you. We will take our next question. Your next question comes from the line of Emily Field. Please go ahead. Your line is open.

Speaker 13

Hi. Thanks for taking my question. I'll just ask 2 quick ones. So the first one for acosomalumab, are we going to be seeing the data at ASCO in the cluster for both cohort A and cohort B? And then a question on DARZALEX and just sort of the multiple myeloma competitive environment.

Speaker 13

Obviously, earlier this year, we saw the DREAM 7 data for blood wrap, which was had DARZALEX in the comparator arm. I know this is second line plus and the share numbers you gave earlier in first line are super helpful. But are you seeing that asset reentry into the market, based on the data you've seen so far as a competitive threat to DARZALEX? Thank you.

Speaker 1

Thanks, Emily, for the questions. I think, Tay, you can probably handle both of the questions. The data at the poster at ASCO for acacitilimumab and then the blend rep new data from GSK and the impact on the DARCELL X landscape?

Speaker 4

Well, so the first thing, I'll take the 1046 and I'll give my impression on the BLENWeb data and then maybe Anton Masini may also have his own view on this. But on 1046, what you will see is the data that we used to make the decision and obviously the decision was 2 fold. 1, what is the appropriate dosing schedule? And B, overall, is there a path forward? What's the proof of concept for this combination?

Speaker 4

And you will see essentially the answer to both of these questions. So that means you will see the relevant data from the arms. On Glenweb, I don't want to sound this way, but it's almost it feels like it's a little bit, I think, a little bit too late as the treatment paradigm has changed and daratumumab has moved into earlier lines. I think the study asked a question that was certainly relevant at the time when it was designed, but may not be necessarily relevant at the time it was answered. And I don't know if Anthony wants to add further to that.

Speaker 2

No, I think you covered it.

Speaker 1

All right. I think we need to leave it with that, I think there's no probably better BCMA targeted molecules like bispecifics and teclistamab as we're doing really well as you heard from Anthony Monsigni.

Speaker 4

Great.

Speaker 1

All right. Operator, let's move to the next question.

Operator

Thank you. Your next question comes from the line of Peter Verdult. Please go ahead. Your line is open.

Speaker 14

Thank you. Peter Verdult, Citigroup. Two questions please. To Yan or Tahira and I ask for your patience here, but I just want to ask Sachin's question differently. On this GENTEEN1046 data, we're going to see why you moved into Phase 3.

Speaker 14

Can I rather than trying to be cute, can I just be a bit blunt? I mean, it's a big area, huge commercial opportunity, but also very competitive. So my simple question is, is there enough data to materially change consensus applications in this drug? Do you feel that there could be a pivotal moment in terms of how people view 1046 given how long we've been waiting for this data to come through? So that's question number 1.

Speaker 14

And then number 2 for Anthony Pagano, just ballpark, when we think about ProFound on an annualized basis, is a good starting point to think of a cost base around $100,000,000 including what might be needed to prosecute reenoracts. Just anything you can help with in terms of a run rate in terms of the profound bio cost base? Thank you.

Speaker 1

Thanks, Peter, for the questions. The first one, I will move on to Thij because he is really on top of that data together with Judith. And we are very excited to present that. And I think it's going to be very clear Peter and take and underlining the decisions we have taken towards Pivotal. But with time, maybe you can give a bit more color for Peter here?

Speaker 4

Yes. I will try. It's not that easy because I don't necessarily know how you guys are going to react because it all depends on like what one has in mind in terms of expectations and reality. The way I look at this and the way I think about this and the way we think about this and the reason we are excited is go something like this. This is going to be an IO option with similar benefits that immune oncology approaches in the past have shown when they were compared against chemotherapy in our mind And that we would be what we hope to achieve with the study, what we hope you will appreciate in the data set is that efficacy is important, durability is probably even more important and overall survival is to zenek or not.

Speaker 4

And so it is indeed a competitive space, but I think it's also fair to say that a lot of the approaches have not met the criteria that I just laid out. They've met maybe one, but not all of them. And I think this is how we look at it. This is why we're excited about it. It's in many ways also validation of a long effort to validate form will be as a mechanism.

Speaker 4

And that in and of itself also has some value for us.

Speaker 1

Thanks, Tayo. I think we should keep it to that. And then finally, also a question for Antony Parcano. I was worried that there wouldn't be a question for you, Anthony, but now you can go.

Speaker 14

I stayed

Speaker 3

on the line, Jan. No worries. And thanks, Pete. Yes, maybe to start off with the shorter term, Pete, in terms of our 2024 guidance is what we indicated as part of announcing the proposed acquisition. And I reiterated again today that for 2024, we expect to be at or moderately above the upper end of our current guidance range, which is DKK 12,400,000,000 to DKK 13,400,000,000.

Speaker 3

And to be clear, as I sort of think about what the upper bound of could be, it's certainly going to have a 13 handle on it, meaning our OpEx numbers are going to start with a 13. We're really focused on, as you would expect, continuing to manage our overall investments in a focused and disciplined way, as we've done historically. Now if I just want to zoom out a little bit, Pete, as you'd expect, we have to invest to unlock the full potential, particularly around RENA S as well as our existing late stage programs. So as I highlighted on our call to announce the proposed acquisition of ProFound, we do expect R and D investments to step up over the near to medium term. What you should be really clear on though is that we fully intend to remain substantially profitable throughout this investment period.

Speaker 3

So we're going to manage our expenses accordingly. And that means that moving forward, we're going to continue to be focused and disciplined in our approach to allocating the capital across these mid to late stage R and D programs with the most potential. As we've done in the past, we're not going to shy away from deprioritizing other programs, particularly early stage programs that won't meet our high bar for continued development. And then finally, and as we talk about RINA S in a little bit more detail, we expect RINA S could be accretive to earnings by the 1st full year of launch given its potential approval in 2027. And as Jan highlighted, we do anticipate that we're going to unlock meaningful value from this program by the end of the decade with significant further upside into the 2030s.

Speaker 3

Maybe one other point Pete, you might have seen this in the Q1 print. When we gave our guidance for 2024, we're very clear that we're managing our investments, particularly as it relates to SG and A. You can see the SG and A print here in Q1 is further evidence of that. We're absolutely focused on making the appropriate investments to run our business the right way. But also when we have clear investment opportunities, particularly these, let's call it registration trials, we can't shy away from making these investments.

Speaker 3

And likewise, when the data aren't clearing the very high bar, we can't shy away that from that either. So I'm not going to give you a precise number. We've highlighted, Pete, that we are

Speaker 7

to run RINA S and then we'll

Speaker 3

be back as part to run RINA S. And then we'll be back as part of our Q2 earnings to provide some incremental detail, particularly as it relates to 2024 numbers.

Speaker 1

Thanks, Anton. Thanks, Peter. Let's see whether there are further questions, operator.

Operator

Thank you. We will take our next question. The question comes from the line of Suzanne Van Voorheesen. Please go ahead. Your line is open.

Speaker 11

Hi, team. This is Suzanne from CLK. Thanks for taking my question. I got disconnected for a bit, so apologies if this is maybe a repetitive question. But I wondered if you can elaborate on the tisotumab data set in head and neck cancer that is coming at ASCO.

Speaker 11

Could you remind us of the potential that you see for the drug in this setting and expand on what we should expect for next month's update in terms of sample size, efficacy metrics and follow-up time? Thank you.

Speaker 1

Thanks, Susan, for the question. And I think, yes, you did miss, I think, some of the updates, but I will ask Una to give you further color on the data set at ASCO for head and neck and TIFTAK at Tigeon Tigeon Fedotan. Judith?

Speaker 9

Yes. Thank you, Ian. So the data is based on a Phase 2 study, RMC. The initial data was presented at ASTRO. So this is a much more substantial data set with longer follow-up.

Speaker 9

The setting is the same. So it's patients with head and neck that failed standard of care, meaning PD-one, chemo and cetuximab.

Speaker 1

Thanks, Judith. And only a few weeks, Susanna, then you will know it all.

Speaker 11

Thanks, Anal.

Speaker 1

Thank you. Let's see, operator, whether there are further questions.

Operator

Thank you. In the interest of time, I will hand back for closing remarks.

Speaker 1

All right. So thank you all for calling in today to discuss Genworth's financial results for the Q1 of 2024. If you have additional questions, don't hesitate to reach out to our Investor Relations team. We hope that you all stay safe and keep optimistic, and we very much look forward to speaking with you all again soon.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

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Earnings Conference Call
Genmab A/S Q1 2024
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