Genmab A/S (GMAB) Q2 2021 Earnings Call Transcript

Image source: The Motley Fool.

Genmab A/S (GMAB -0.70%)
Q2 2021 Earnings Call
Aug 11, 2021, 12:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Hello, and welcome to the Genmab Q2 2021 Conference Call. Throughout the call, all participants will be in a listen-only mode, and afterwards there will be a question-and-answer session. And just to remind you, this conference call is being recorded.

During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless this is required by law.

Please also note 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. And please refer to our website for more information on Genmab and our privacy policy.

Today, I'm pleased to present Jan van de Winkel. Please go ahead with your meeting.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Hello, and welcome to the Genmab conference call to discuss the Company's financial results for the first half of 2021. With me today to present these results is our CFO, Anthony Pagano. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky; our Chief Operating Officer, Anthony Mancini; and our Chief Medical Officer, Tahi Ahmadi.

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 a science-focused and 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. Referenced on this slide are some of the many successes that propelled our growth throughout our 22-year history. One key factor in our future growth is the breadth and depth of our proprietary pipeline, which we anticipate will expand to nine programs in the clinic by the end of this year.

So now, let's move to Slide 5 and look at some of the recent achievements in our pipeline and beyond. We moved a major step closer to our goal of bringing our own medicines to patients with the FDA's acceptance of the tisotumab vedotin BLA for priority review. Data from the clinical trial on which the BLA was based, the innovaTV 204 Phase II study, was also recently published in The Lancet Oncology. As we shared with you last quarter, the PDUFA target date for our potential US FDA approval is October of this year. Along with our partner CGEN, we look forward to updating you on the progress of tisotumab vedotin in metastatic cervical cancer in due course.

Data from two of our other pipeline products was also featured at recent medical conferences, including multiple presentations of updated dose escalation data for epcoritamab and a presentation of pre-clinical data for GEN1042, one of our DuoBody products in co-development with BioNTech. Excitingly, we are anticipating an additional DuoBody product in the clinic by the end of the year, following a recent CTA submission for DuoBody-CD3xB7H4 or GEN1047. This may have potential in solid tumors. We look forward to additional pipeline expansion in the future, including potentially from our oncology research and development collaboration with Bolt Biotherapeutics.

In addition to focus in our own pipeline, the power of Genmab's innovation was reflected in important updates for products being developed by other companies. Inclacumab, formerly in development with Roche, is now in Phase III development with Global Blood Therapeutics. The pivotal studies are assessing the safety and efficacy of inclacumab and reducing the frequency of vaso-occlusive crises, or VOC, related hospital readmissions in patients with sickle cell disease.

There were also exciting updates for clinical-stage products that incorporate our DuoBody technology. Novo Nordisk published pre-clinical data on the DuoBody based Mim8 in the Journal of Blood. And multiple abstracts evaluating Janssen's bispecific program leveraging Genmab's DuoBody technology platform were presented at this year's ASCO. In June, Janssen also announced that the FDA granted Breakthrough Therapy Designation for teclistamab in the treatment of relapsed or refractory multiple myeloma.

So now, let's move to Slide 6 and look at the most significant milestones to date for Genmab's DuoBody technology. In May this year, Janssen received FDA approval for RYBREVANT for patients with metastatic non-small cell lung cancer with epidermal growth factor receptor Exon 20 insertion mutations. This is the first regulatory approval for a therapy created using our proprietary DuoBody technology, and we hope this is the first validation of many of the major potential of this innovative technology to create truly differentiated bispecific antibody therapeutics.

With the approval of RYBREVANT, there are now four therapies on the market that incorporate Genmab's innovation. DARZALEX, which has now been part of the treatment regimen for over 200,000 patients, continues to evolve with additional approvals in both Europe and the US. The approved indications for multiple myeloma expanded in both territories based on the Phase III APOLLO study. And subcutaneous daratumumab is now the only approved therapy for AL amyloidosis in both US and in Europe. DARZALEX was also granted an approval in China based on the Phase III LEPUS study, which examines daratumumab in combination with VELCADE and dexamethasone in patients with relapsed or refractory multiple myeloma.

Sales in the first half of the year were also strong. And we reported $2,798 million in net sales by J&J, an increase of 52% over the first half of 2020, resulting in DKK2,360 million in royalties to Genmab. We are enthusiastic about the future of all four of these medicines, as they exemplify our commitment to applying our world-class antibody expertise to create differentiated antibody therapeutics with the potential to fundamentally improve patients' lives. The collaborations for these medicines provide us with recurring revenue from royalties, which we can then use to invest further in our business to deliver on our inspirational vision.

I'm now pleased to turn the call over to Anthony, who will discuss our revenue in more detail. Anthony?

Anthony Pagano -- Executive Vice President and Chief Financial Officer

Great. Thanks Jan. Let's move to Slide 7. As I've done in the past, I'd like to start with an overview of our financial framework and the related key drivers. First off, let's think about our revenue profile. On the left, you can see our current and future recurring revenue streams. There are now four approved products created using our innovation. That's DARZALEX, Kesimpta, TEPEZZA, and most recently, RYBREVANT. Each of these have exceptional growth profiles. Taken together, we expect them to generate significant cash flows for us in the years to come. Then we have an additional potential revenue stream that could come online later this year, as we submitted the BLA for tisotumab vedotin in Q1. If tiso is approved, that will bring the total number of approved products to five, which for me is really exciting.

Now, on to our focused approach to investment shown on the right. We'll continue to invest in our business and capabilities to position us for sustained success. And we will accelerate and expand the potential winners in our pipeline, and we'll also ensure we are ready to launch should tiso and in the future epcoritamab be approved. As well as investing, we will of course remain focused on the bottom line.

Now with this context set, let's take a closer look at an important component of our recurring revenue growth, DARZALEX sales on Slide 8. We saw continued strong performance for DARZALEX in the first half of 2021. You can see that in the chart on the left. Overall DARZALEX sales grew by 52%. That's net sales of approximately $2.8 billion, which translates to DKK2.36 billion in royalty revenue. This exceptional growth was driven by continued strong market shares across all lines and by the strong uptake of the SubQ formulation. So DARZALEX remains a key driver of our revenue, as you can see on Slide 9.

Looking at the graph on the left, you can see our recurring revenues grew by 49% in the first half of the year, primarily due to higher DARZALEX royalties. We've already spoken about DARZALEX and the very strong performance there.

Moving to Kesimpta, we're encouraged by the nice quarter-over-quarter growth seen in the first half of the year. For TEPEZZA, due to the supply chain disruption, we didn't record any royalties for the first quarter. However, Horizon started to supply the market again in April with strong sales reported in Q2. We're also enthusiastic about the recent approval of RYBREVANT and look forward to seeing how sales progress.

So, our revenue profile continues to get stronger with increases both in recurring and non-recurring revenue, after excluding of course the one-time upfront payment from AbbVie in 2020. And we're taking our strong recurring revenues and investing in a highly focused way, as you can see on the next slide.

Total operating expenses grew 26% in the first half of the year. And here, you can see where we invested. We continue to accelerate our investment in our product portfolio, especially the advancement of both epco and DuoBody-PD-L1x4-1BB. We've also continued to strategically spend on expanding our team, hiring key team members to support our growing product pipeline. And we've continued to build our commercialization and broader organizational capabilities to support our expansion. Finally, we are leveraging the AbbVie collaboration by utilizing their expertise and significant financial contributions to further expand and accelerate our partnership programs.

Now let's look at our financials as a whole on Slide 11. Here you can see our summary P&L. For H1, revenue came in at approximately DKK3.6 billion. That's up 83% on last year, if we exclude the one-off payment from AbbVie in 2020. Total expenses were about DKK2.2 billion, with 79% being R&D and 21% G&A. Operating income was DKK1.3 billion compared to DKK4.6 billion last year. This was also impacted by the upfront payment from AbbVie. Our net financial items amounts to a gain of DKK527 million, which was primarily driven by the strengthening of the US dollar against the Danish kroner on our US dollar denominated cash and investments. Then we have tax expense of DKK444 million, which equates to an effective tax rate of 24%. And that brings us to our net income of around DKK1.4 billion. So, as you can see, extremely strong financial performance for the first half of 2021.

Now, let's look at our guidance on Slide 12. Following our strong first half numbers, we are improving certain aspects of our 2021 guidance. We now expect our revenue to be in the range of DKK7.3 billion to DKK7.9 billion, driven primarily by the continued strong growth of DARZALEX. Our OpEx guidance will stay in the range of DKK5.5 billion to DKK5.8 billion, as we continue to step-up our investments in the second half of the year, in line with our overall strategy and our 2021 key priorities. Putting this together, we're planning for substantial operating income in 2021 in a range of DKK1.5 billion to DKK2.4 billion.

Now, for my final slide, let me provide a few closing remarks. In summary, we've had a very solid first half. We've created growing recurring revenue streams based on products with exceptional growth profiles. 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 capitalize on the significant growth opportunities in front of us.

And on that note, I'll hand you back to Jan to discuss our key priorities.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thank you, Anthony. Let's move to Slide 14. Our world-class team continues to work tirelessly to meet the many ambitious goals we set for ourselves for this year. We are especially excited to share updates on our clinical programs, including data from both our DuoBody and our HexaBody-based proprietary programs. As we continue to build our pipeline and evolve into a leading fully integrated biotech innovation powerhouse, we are looking forward to a busy second half.

So, let's now move to our final slide, which is Slide 15 that ends our presentation of Genmab's first half of 2021 financial results. Operator, please open the call for questions.

Questions and Answers:

Operator

[Operator Instructions] Our first question comes from the line of Wimal Kapadia from Bernstein. Please go ahead.

Wimal Kapadia -- Bernstein -- Analyst

Great. Thank you very much for taking my question. So, can I just ask on epco, just curious how you think about the POLARIX data from earlier this week from Roche suggesting we have a new standard of care in first-line DLBCL. Just wanted to hear your thoughts on a potential trial for epco with POLIVY, how quickly you could begin a pivotal trial in this setting. And curious if you actually believe first-line DLBCL is the largest opportunity for epco at least based on what we know about the molecule today. Thank you.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Wimal for the question. And I'm going to pass the question on the POLIVY trial to Judith Klimovsky, and then Anthony Mancini can potentially detail the first line diffuse large B-cell lymphoma market opportunity. I can tell you Wimal, we are going for that for sure. And Judith can explain how the POLARIX data may potentially impact the route for diffuse large B-cell lymphoma. Judith?

Judith Klimovsky -- Executive Vice President and Chief Development Officer

Yeah. Thank you, Jan. So, we are aware of the result same as you. Thank you for the question. So far, we have a high level announcement without details on the data. As soon as the granularity of the data become available, we will assess it thoroughly and determine what is the impact or what other steps we need to take to ensure our clinical development plan is aligned with the most current potentially standard of care. So, it's very premature to say because we don't know the results in detail.

Anthony Mancini -- Executive Vice President and Chief Operating Officer

And Wimal, just to follow on, on that in terms of the market opportunity, we certainly see the frontline DLBCL opportunity as a significant one for epcoritamab, but we also see a broader lymphoma opportunity as well. So I think again, as Judith commented, it's early -- too early to comment at this point, and we'll certainly ensure you're informed as we evolve the strategy.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thank you both. Wimal, I think I'll give it back to you now.

Wimal Kapadia -- Bernstein -- Analyst

Okay, great. Thank you very much.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thank you.

Operator

And the next question comes from the line of Matthew Weston from Credit Suisse. Please go ahead.

Elizabeth Wilson -- Credit Suisse -- Analyst

Hello, good afternoon, this is Elizabeth Wilson on for Matthew Weston. I'm wondering if you can help us a little bit on costs. We've seen you raise your sales guidance but not your guidance for your operating expenses. Perhaps you can help us think about the cadence of your commercial spending, given that tisotumab Japanese submission is delayed. And then perhaps on the R&D spending, you've underspent versus consensus expectations for this quarter. Can you also help us there in thinking about your cadence of R&D spending going forward? Thank you.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Elizabeth for both questions. And I will hand them over to Anthony Pagano. Anthony?

Anthony Pagano -- Executive Vice President and Chief Financial Officer

Sure. Thanks. Thanks, Elizabeth. You're right. I think overall, H1 costs were a bit on the low side relative to our full year guidance. Maybe starting on the R&D, expenses were impacted by phasing of costs related to the various pipeline programs and particularly epco and DuoBody-PD-L1x4-1BB. Here from our perspective, it's a matter of timing, and we expect cost related to these programs and other programs and sort of R&D activities more broadly to ramp up in the coming quarters. And we also had some chunky CMC investments to come later in the year. And as a reminder on epco together with AbbVie, we are still planning some additional late-stage trials. So more to come on that.

So overall, from the R&D perspective, it's primarily timing and phasing, and we expect to make up a lot of it in the second half of the year.

On the SG&A side, our focus here really is on the near-term potential launch of tisotumab vedotin. Team is really geared up to make sure we're ready if that -- ultimately the PDUFA date is hit in October. Team is working hard on that. Maybe in a minute, Anthony Mancini will put [Phonetic] a bit of color on that one. And at the same time, we're also super excited about epco in this regard. The team is preparing for epco in potential launch and overall making some important investments in building the overall commercialization infrastructure and a lot of exciting pre-launch activities.

So in summary, Elizabeth, we believe our 2021 guidance on opex to be at the right level for now. Anthony, anything you want to add as it relates to SG&A and some of the prep going on for tiso?

Anthony Mancini -- Executive Vice President and Chief Operating Officer

Yeah. I just, Anthony, would add just a couple of comments as it relates to tisotumab vedotin. And one of the important things is that we are now, as Jan alluded to earlier, working toward launch readiness for the target PDUFA date of October 10 for tisotumab vedotin in collaboration with our partner, CGEN. We actually are now launch already in the US with fully trained field teams in place in anticipation of that PDUFA date, and we're really looking forward to a robust launch. We have robust launch plans in place, and we're confident that we can ensure broad awareness and adoption of TV upon approval. So that's kind of where I'll leave it.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Anthony and Anthony. Thank you, Elizabeth, for the question.

Operator

And the next question comes from the line of Emily Field from Barclays. Please go ahead.

Emily Field -- Barclays -- Analyst

Hi. Thank you for taking my question. I hope I'm not getting too sleuthy here, but it looked like in your internal development chart that the color bar for GEN1042 advanced this quarter from last quarter. So I was just wondering if you could give us an update on when we may see that dose escalation data in the back half of this year and any guidance into what tumor type we may potentially see that in?

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Emily. I think what I can say is that we have submitted multiple abstracts to different conferences and also an abstract for GEN1042 for one of the conferences in the coming months. We haven't yet received feedback on whether it's accepted. But what I can tell you is that we are super, super excited about the data, the 1042, and I hope that you will share that sentiment with us once you see the data. It's a bit too early to comment on the exact tumors. But what I can tell you is that we have seen signals in multiple tumors. So we have to further explore probably which ones to pursue, but we are very, very excited about 1042.

Emily Field -- Barclays -- Analyst

Thank you.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thank you, Emily.

Operator

And the next question comes from the line of James Gordon from J.P. Morgan. Please go ahead.

James Gordon -- J.P. Morgan -- Analyst

Hello. James Gordon, J.P. Morgan. Thanks for taking the question. A question on GEN1046 please. The question is that GEN1046 is the only [Indecipherable] PD-L1 bispecific in the clinic. So, beyond maybe time to market, where are you seeing differentiation versus some other companies that are also following the same approach? And also just in terms of how we might think about what data we're going to see next, is it logical to think that we're going to see the data all in one big lump, so potentially something like SITC in mid-November? Or are we going to get the data at various different conferences over the year for the 9 or 10 cohorts, please?

Jan G. J. van de Winkel -- President and Chief Executive Officer

So this is a question related to GEN1046 I think, James. I didn't catch that in the beginning. Why don't we pass over that -- yeah, why don't we pass it over to Tahi Ahmadi, and Tahi can give you some further color on the type of data you can expect in the coming time, James. Tahi?

Tahamtan Ahmadi -- Executive Vice President and Chief Medical Officer, Head of Experimental Medicines

Yeah. So if I understood -- thank you. If I understood the question correctly, there were two components. One was on the construct in and of itself. And I think we've spoken many times about the complicated biology of engaging 41BB in this conditional activation that we try to achieve with our model. And as it relates to the advantages that come from the DuoBody platform to try to interrogate that complicated biology, so we feel very comfortable and confident in our asset because we knew how difficult it was to get actually [Indecipherable] the biology that we were looking for.

As it relates to the data, and then it's probably fair to say that there will be some data readouts as data becomes available. We're continuously enrolling and obviously generating data, and we will probably add some updated data at SITC, again similar to the comment that was made at 1042. Obviously, we have submitted some data, but we have not yet confirmation that this will be presented. And for the other tumor types, as we generate the data, we'll present them at an opportune time when the data is mature in the updating conferences, probably more in the first half of next year.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Tahi. Thanks James for the question. Operator, next one.

Operator

The next question comes from the line of Michael Novod from Nordea. Please go ahead.

Michael Novod -- Nordea -- Analyst

Yeah. Thanks a lot. So just a question to epco in CLL. Maybe you could just provide weather some of the data you've submitted at conferences also include some of the initial data, I know it's early, but data in CLL. And then secondly, maybe you could just remind us about the inclacumab royalties and economics with [Indecipherable]? And then, last in terms of your data sales guidance, I know it's of course also based on what sort of feedback you get from J&J, but the midpoint indicates no growth between the first half and -- or the low point -- no growth between the first half and second half. Is that even realistic? And if it is realistic, then what should drive no growth in sales in the second half? Thanks.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks for the questions, Michael. I will handle the first two and then pass the third question over to Anthony Pagano. So definitely, epco multiple datasets submitted, Michael. And I'm willing to say here also including the early data for CLL from the first patients. And let's hope that we can present them near the end of the year. Then economics for epcoritamab, this is another program, which we started off with Roche in the early -- I think it was around 2003 to 2004 time frame. Economics are very similar I can tell you to the TEPEZZA economics, Michael. I don't know the exact milestones here, but they're very, very similar. The contract -- the molecule was made in the same era as teprotumumab, so I probably want to leave it with that and hand the other question over to Anthony Pagano.

Anthony Pagano -- Executive Vice President and Chief Financial Officer

Yes. Thanks Michael. And I guess, after a strong start to the year, I can see why you'd ask the question. For me at this stage, our guidance sort of feels at the right level. And let me spend a couple of moments and explain to you why. To start and sort of thinking about the growth rates that we saw in the first half of the year, I think it's useful to remember that the year-over-year growth rates that we saw were positively impacted by some of the favorable comps due to the softness we experienced in the early parts of 2020 due to COVID.

And turning to our guidance, when we think about our revised guidance for dara, we really focused on two main scenarios to kind of bookend it for you, Michael. First, the 5% sequential growth rate we saw in Q2, and this is really the most recent data point we have and reflects the continued very strong fundamentals for dara, where we've seen very nice market shares across the board, particularly in frontline where we've seen some meaningful gains in the US, and this, of course is coupled with ongoing strong uptake of the SubQ formulation. So this level of continued growth gets us toward the top end of our guidance range of DKK5.9 billion.

So, the second scenario and the second sort of point I'd like to make, Michael, is unfortunately, as you know, we also find ourselves in the midst of a global pandemic. As we've heard from a number of the other companies, COVID continues to represent a challenge in diagnosing new cancer patients, and in some cases, getting the needed treatment to existing cancer patients. Now, for sure, so far, this doesn't seem to have been a significant barrier for dara. But it's something I think we do need to be mindful of and take into consideration when formulating our guidance. So here, to reflect what I just explained and the fact that we could see some unexpected choppiness in the second half of the year, we assume that H2 sales level that approximates H1, and that gets us to the bottom end of our guidance range of DKK5.6 billion. So, when you take this all together, we believe that the DKK5.6 billion to DKK5.9 billion is the right level for us overall.

And maybe just to step back for a second though, overall, we continue to be super pleased with the very, very strong fundamentals of dara, the continued investment that's being made in terms of continued development of dara, as well as the overall growth profile for DARZALEX sort of generally.

Michael Novod -- Nordea -- Analyst

Okay, great. Thank you.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Anthony. Next question, operator?

Operator

The next question comes from the line of Michael Schmidt from Guggenheim Securities. Please go ahead.

Michael Schmidt -- Guggenheim Securities -- Analyst

I had another one on epcoritamab. I noticed that your broad Phase I/II study, the 480-patient study is still enrolling patients. Just curious if you could update us how you're tracking toward completion of enrollment of some of those cohorts and how you're thinking about potential time lines for accelerated regulatory submission in some of those indications.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks for the question, Michael. I will hand it over to Tahi Ahmadi, who is on top of the recruitments. Tahi?

Tahamtan Ahmadi -- Executive Vice President and Chief Medical Officer, Head of Experimental Medicines

Yes, I am on top of the recruitment but I'm not entirely sure if I will communicate them in detail. But, the study has multiple arms with different B-cell malignancies that are obviously accruing at different speeds because of the different incidence prevalence as it relates to the specific inclusion exclusion criterias for relapsed/refractory diffuse large B-cell, relapsed/refractory follicular lymphoma and relapsed/refractory large B-cell lymphoma. So, it's a little bit too early to speculate on the time lines. But we are quite happy with where we are in the recruitment, particularly with the COVID challenges that certainly have had implications broadly across the entire landscape. We've been enrolling basically on our projections.

Michael Schmidt -- Guggenheim Securities -- Analyst

And as a quick follow-up...

Jan G. J. van de Winkel -- President and Chief Executive Officer

Michael, please go ahead.

Michael Schmidt -- Guggenheim Securities -- Analyst

I was just curious, sorry, Jan, about the data update on epco later this year. Will this be another follow-up on the Phase I data, or will this include some of those Phase II cohorts as well?

Jan G. J. van de Winkel -- President and Chief Executive Officer

What I can say, Michael, is that we have submitted multiple abstracts, and that will include data. I already said that in my answer, the first answer on CLL, but it will also be potentially some combination data -- combination therapy data, which is new, which you haven't seen anything from -- and potentially updates, of course, on the -- already the Phase I/II data, which you have seen already before. So, it will be a combination of data. And I think we're very excited about, I think, the potential of epco. We believe it will be an absolute transformative therapy in the lymphoma space, and we can't wait to hear back from the conferences, Michael, that the objects are accepted. And then, we will have an open discussion on that.

Tahamtan Ahmadi -- Executive Vice President and Chief Medical Officer, Head of Experimental Medicines

And maybe to add to the question, I think that general like registration-enabling -- or potential registration-enabling data sets are usually first submitted to health authorities before they are presented in the public.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Tahi.

Operator

And the next question comes from the line of Graig Suvannavejh from Goldman Sachs. Please go ahead.

Graig Suvannavejh -- Goldman Sachs -- Analyst

Hey. Thank you very much. Good afternoon, everyone. Thanks for the update as well. Just two questions. One, in your interim report, you quantified the potential impact of the outstanding DARZALEX litigation at DKK146 million. I was just wondering if you could provide any color on the math on how you got to that. And then, assuming continued growth in DARZALEX SubQ, would you expect that for the second half, it would be somewhere in that neighborhood or slightly greater? So, that's my first question.

And then second, just on DARZALEX SubQ. Halozyme reported earlier this week and they shared that they had data to suggest that the conversion from IV to SubQ was about 66% in the US. So, I was just wondering if you -- if that data matches kind of what you're seeing in the US? And can you comment on what you think that conversion looks like outside the US? Thanks so much.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Graig for the question. So the first one can probably best be handled by Anthony Pagano and the second question on the conversion rate and then how it looks in the US versus rest of the world can probably be addressed by Antony Mancini. Maybe Anthony Pagano, you can start.

Anthony Pagano -- Executive Vice President and Chief Financial Officer

Yeah, Graig. So, we'll just have some fun, just some math together here. We provided our original [Technical Issues] for 2021. I talked about, call it, the headwind as it relates to what Janssen is doing in terms of withholding some royalty from us [Technical Issues] the appropriate thing is [Technical Issues] not recognize that revenue. That's exactly what we've done. I highlighted at the beginning of the year that we thought the impact [Technical Issues] DKK150 million. Now with the improved guidance, that would be DKK500 million on a full year basis.

How do you get to that number? So effectively, it's a function of what the total SubQ sales are relative to total sales. If you multiply that through and [Technical Issues] you referenced here for H1 [Technical Issues] or so. I think on a go-forward basis, as we've kind of already seen [Technical Issues] total level of sales of SubQ to be higher, continue to grow as we move forward. So, we do expect that number to increase significantly in the second half of 2021, as total sales increase [Phonetic] but also as the total amount of SubQ sales relative to IV sales also continues to grow up. Hopefully, that helps you get to the math. I can't give you [Technical Issues] royalty rates, etc., specific amounts what Janssen is withholding. It's just something we're not part [Technical Issues].

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Anthony. Maybe Anthony Mancini, some color on the conversion from IV to SubQ?

Anthony Mancini -- Executive Vice President and Chief Operating Officer

Thanks Jan, and thanks Graig for the question. On IV and SubQ usage, it's really about data set. So what Halozyme [Technical Issues] depend on the data set. But it's largely in line with what we're seeing based on IQVIA and Symphony data. And at the end of Q2, what we saw about 64% of US [Technical Issues] expressed in terms of [Technical Issues]. Your question about outside the [Technical Issues] and obviously, Graig, that number continuing to evolve in a positive way with [Technical Issues] steady positive trend in favor [Technical Issues] US. If you look at more recent [Technical Issues] IQVIA and Symphony data. But if you look at outside of the US, now that the [Technical Issues] formulation is launched in the EU and [Technical Issues] achieved public reimbursement in a good majority of countries, in fact, one of the top five EU countries, we can say that it's about 54% already SubQ, and that's really highly very [Technical Issues] on the system [Technical Issues] in each of the countries, which, as you know, are very different. So hopefully, that gives you a little bit of color on SubQ inside the US and outside [Phonetic].

Graig Suvannavejh -- Goldman Sachs -- Analyst

That's great. If I could, just a quick follow-up. What do you think that max conversion could look like? I think there's a good reason to think that some patients would prefer to stay on IV for a variety of different, whether it's social factors. But can you help us think about where you think ultimately this conversion could go to?

Jan G. J. van de Winkel -- President and Chief Executive Officer

Anthony, do you want to comment on that?

Anthony Mancini -- Executive Vice President and Chief Operating Officer

Yeah. I can sort of give you my sense of this. Look, normally, when you have a subcutaneous version and an IV version practice, economics play a factor in sort of determining where it could go. Because in the case of FASPRO, that's really not a factor because they continue to both be in Part B. We really don't see any huge barriers to continued SubQ adoption in the US. And so, I think because of the -- in fact, it's quite the opposite. It's three to five-minute injection versus a multi-hour infusion. So, we actually see more advantages than any disadvantages. And you mentioned kind of the social aspect of the infusion. It's hard to tell exactly where that would sit, but there's no other real reasons to not use SubQ. Just hopefully, that gives you a little bit of color, Graig.

Graig Suvannavejh -- Goldman Sachs -- Analyst

Yeah. Thank you very much.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Graig.

Operator

And the next question comes from the line of Jonathan Chang from SVB Leerink. Please go ahead.

Jonathan Chang -- SVB Leerink -- Analyst

On the Bolt collaboration, can you discuss the rationale behind partnering with Bolt to evaluate bispecific immune stimulating antibody conjugate therapeutics? And how does this platform compare to others, you may have evaluated in the process? I'd also be curious to know how you think about target selection for this approach. Thank you.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Jonathan for the questions. I will happily hand it over to Tahi, but I can tell you that we have had intense discussions with multiple candidates for these type of conjugates. And we're super excited about the Bolt Biotherapeutics technology and platform. And we have -- we are already working with them now on a very large number of target programs. But, let me ask Tahi to first give a perspective on why we have selected the Bolt technology, and then maybe I can add to that at the end. Tahi?

Tahamtan Ahmadi -- Executive Vice President and Chief Medical Officer, Head of Experimental Medicines

Well, so -- I mean, let's start -- first, thank you for the question -- that we have -- as Jan was saying, we're very enthusiastic about the potential of engaging in the immune -- innate immune system and see this very complementary to some of our mechanisms that we are currently having in clinical development or that are going to come in clinical development in the very near future. So, it's very -- a complementary strategy to the things that we have already been working on, either stand-alone or collaboration BioNTech. We have looked, of course, at a number of companies that are working on this. We felt at the time that all of these deals that there was a good collaborative spirit and a joint scientific idea and belief with the colleagues at Bolt. So, this was one important part, and we also felt that they were very much leading, or at least on top of the field as it is emerging. And I think it's -- all that is as to say at this point, as Jan alluded to, as these discussions went on, we had a lot of work that was already done in terms of proof-of-concept. And so, we are quite happy with what we saw, which led to the deal, and I don't think we would, at this call, give any indications on targets, except that this is a very important cornerstone of our future strategy.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Tahi. What we should also say is that the approach is, of course, already clinically validated, Jonathan, in the HER2 space. This is very different from some other technology platforms. So, we are very, very excited. We have already, I think, more than several handful of potential targets we are pursuing, both at monospecific and with bispecific. So, I think there's definitely more to come here, Jonathan. And we're very, very excited about this new partnership, and we will focus it maximally from here.

Operator

[Operator Instructions] We have one more question from the line of Asthika Goonewardene from Truist Securities. Please go ahead.

Asthika Goonewardene -- Truist Securities -- Analyst

I hate to dwell on this, but it's just important for us to understand. So, I appreciate any color you can give here. For SITC, so GEN1042, Jan, you mentioned that there was a single abstract submitted. I'm curious if you can tell me how many abstracts with clinical data were submitted for GEN1046? And then, if I can tag on just another catalyst related question here. Previously, you've alluded that you might have epcoritamab NHL expansion data this year. I just want to know if you have any abstracts for that -- the NHL expansion being submitted. Thank you.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Asthika. I think I can answer you that for 1046, we have submitted any abstracts. And for epcoritamab, we are not commenting on that because we have multiple abstracts data from different studies. So, we are not going to comment on that until we have heard back from the conference, Asthika, on whether that's acceptable or not.

Asthika Goonewardene -- Truist Securities -- Analyst

Got it. Thanks guys.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thank you.

Operator

And we have one final question from Kennen MacKay from RBC. Please go ahead.

Kennen MacKay -- RBC -- Analyst

Hi. Congrats on the quarter and guidance. And thanks for squeezing me in here. Jan, you mentioned epco potentially being a blockbuster therapy. I think another one from your pipeline that could fit that though is Cami, the ADC in development in collaboration with ADC Therapeutics. Just wanted to get your perspective on that asset and whether or not that GBS signal that's being seen there is something that could improve as that moves forward in standard of care and Hodgkin's are in solid tumors, or if there's really any understanding of sort of where that's coming from? Thanks and congrats again.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Kennen for the kind remarks and for the question. I'm going to hand over the ADC Therapeutics question on to Tahi. I think, he is always on top of that data. And Tahi can maybe give you a bit of perspective on how we look at that on the IL-2 receptor ADC concept. Tahi?

Tahamtan Ahmadi -- Executive Vice President and Chief Medical Officer, Head of Experimental Medicines

Sure. Yes. So, the challenge with this concept, of course, is the toxicity related to the payload, which is difficult to manage. And I think the team at ADCT is continuously working to optimizing the management of these toxicities. And so, I think there's still some work to be done in order to fully assess the opportunity for Cami in both, solid as well as in Hodgkin. Because as the data right now, there are some concerns around the tolerability, particularly if you want to go into combination in the future. It's probably all we can say from our end.

Jan G. J. van de Winkel -- President and Chief Executive Officer

Thanks Tahi.

Operator

And as there are no further questions, I'll hand it back for closing remarks.

Jan G. J. van de Winkel -- President and Chief Executive Officer

So, thank you for calling in today to discuss Genmab's financial results for the first half of 2021. If you have any additional questions, please reach out to our Investor Relations team. We hope that you all stay safe and remain healthy. And very much look forward to speaking with you again soon.

Operator

[Operator Closing Remarks]

Duration: 45 minutes

Call participants:

Jan G. J. van de Winkel -- President and Chief Executive Officer

Anthony Pagano -- Executive Vice President and Chief Financial Officer

Judith Klimovsky -- Executive Vice President and Chief Development Officer

Anthony Mancini -- Executive Vice President and Chief Operating Officer

Tahamtan Ahmadi -- Executive Vice President and Chief Medical Officer, Head of Experimental Medicines

Wimal Kapadia -- Bernstein -- Analyst

Elizabeth Wilson -- Credit Suisse -- Analyst

Emily Field -- Barclays -- Analyst

James Gordon -- J.P. Morgan -- Analyst

Michael Novod -- Nordea -- Analyst

Michael Schmidt -- Guggenheim Securities -- Analyst

Graig Suvannavejh -- Goldman Sachs -- Analyst

Jonathan Chang -- SVB Leerink -- Analyst

Asthika Goonewardene -- Truist Securities -- Analyst

Kennen MacKay -- RBC -- Analyst

More GMAB analysis

All earnings call transcripts