Genmab A/S (GMAB) 2015 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by and welcome to the first-quarter financial results for Genmab. At this time, all participants are in a listen-only mode. There will be a presentation followed by a question-and-answer session. (Operator Instructions).

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 it is required by law.

I must advise you that this conference is being recorded today, Tuesday, May 12, 2015.

I would now like to hand the conference over to your speaker today, Genmab CEO, Jan van de Winkel.

Hello and welcome to the Genmab conference call to discuss the Company's financial results for the quarter ended March 31, 2015. Joining me on today's call is David Eatwell, our CFO.

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. At the core of Genmab is a desire to improve the lives of cancer patients. To do this successfully, we aim to build a sustainably profitable company that creates value for shareholders and patients alike.

Our robust product development product pipeline includes ofatumumab, on the market as Arzerra, for refractory and first-line CLO; daratumumab, for which we have announced five Phase III studies in multiple myeloma; HuMax tissue factor ADC in Phase I development; and numerous preclinical products. Our future clinical pipeline will include products based on our cutting-edge DuoBody and HexaBody platforms, as well as oral technologies such as antibody drug conjugate technologies, also known as ADCs.

Partnerships are a key part of our business model, but we also seek to build greater value in the Company in the future by holding onto products longer and through potential product opt-in deals where we retain a greater share of product rights. All together, these elements will help us achieve our vision for the future -- by 2025 our own products have transformed cancer treatments and we have a pipeline of knock-your-socks-off antibodies.

Let's move to Slide 4. So far this year, we have made important progress with our two most advanced efforts, daratumumab and ofatumumab. As we discussed at the year-end results call, we reported positive preliminary results from the Phase II study of daratumumab in double refractory multiple myeloma at the beginning of February this year. The results showed a 29.2% overall response rate, a 7.4 month median duration of response in patients treated with 16 milligram per kilogram of daratumumab, and a manageable safety profile.

We very much look forward to presenting additional data in an oral presentation at the 2015 annual meeting of the American Society of Clinical Oncology to be held at the end of this month in Chicago. As the abstract for this presentation was classified by ASCO as latebreaking, it will not be released tomorrow together with the other accepted abstracts. Results will instead be released during an ASCO press briefing at the meeting on Saturday, May 30. Together with Janssen, we have productively discussed the Phase II data with the US and key EU regulatory authorities but we are not able to provide any details on those discussions at this time.

We also recently announced the fifth milestone of the daratumumab collaboration with Janssen, this time a $10 million payment for progress in the Phase III study of daratumumab in combination with Velcade, melphalan and prednisone, or VMP, versus VMP in front-line multiple myeloma.

The ofatumumab agreement with GSK has now been fully transferred to Novartis and we are very pleased to report the positive topline data from the Phase III study of ofatumumab in combination with fludarabine and cyclophosphamide, or FC, in relapsed CLO. The study met the primary endpoints and together with Novartis, we intend to discuss the potential for a label expansion for ofatumumab with the regulatory authorities. We plan to present additional data from this study at a key upcoming medical conference.

On the partnering front, we entered a commercial DuoBody technology agreement with BioNovion following a July 2014 research collaboration. We will work together with BioNovion to create and evaluate a number of DuoBody product candidates that target central immune checkpoints. The rights to the products will be shared 50-50 if we select a product candidate for joint clinical development. We are enthusiastic about this partnership in immuno-oncology, one of the most exciting areas in cancer therapy that has shown a lot of potential.

We continue to look for opportunities to build a truly differentiated future product pipeline, and to that end, we recently acquired antibodies, patents, and know-how from the French biotech company iDD. The antibodies are directed DR5, also known as the TRAIL Receptor 2. This could have potential in treating various cancers. The antibodies are in preclinical development where we use our world-class next-generation antibody technology expertise to create potential leapfrog antibody therapeutics. And the next step will be to select a lead candidate for clinical development.

Consistent with our wish to selectively invest only in the promising projects, we decided not to opt into a 50-50 cost and posit sharing for the HuMax TAC ADC program under our collaboration with ADC therapeutics. We will, however, retain 25% of the rights to that product without bearing any costs.

Lastly, we remain focused on the financial bottom line and have improved the Q1 operating result by DKK77 million compared to Q1 last year.

I will now hand over the call to David to discuss in detail our financial results for the period. David?

Thank you very much Jan. Let's move to Slide 5. Over the next few slides, I'd like to discuss the results for our first quarter of 2015 and review the guidance for the full year. Let's start on Slide 5 by looking at the income statement for the quarter.

Revenue for the quarter came in at DKK107 million, and that was a decrease of DKK140 million, or 57%, compared to Q1 2014. This decline was anticipated as it mainly relates to the timing of daratumumab milestones. I'll show you more details when we get to the revenue slide.

Expenses also came in lower than last year though at DKK110 million compared to DKK151 million in the first quarter of 2014. I expect the expenses to increase in the coming quarters as investments in new projects begin to come through. Again, more on the expenses in a later slide.

Next, the other income. This is a new line item in our income statement for this year and this year only. As previously discussed, with the transfer of the ofatumumab collaboration from GSK to Novartis, we agreed with GSK that they would forgive Genmab's long-term liability. And as the transaction was completed in early March, we have reported this one-off credit of DKK176 million as a separate line in our income statement.

Moving to the operating income for the first quarter, 2015 came in at DKK173 million compared to DKK96 million in the same period last year. That's an increase of DKK77 million, or around 80%.

The net financial items and tax were also a positive DKK44 million in Q1, compared to just DKK3 million in Q1 2014. The improvement was mainly due to foreign currency related gains. And that takes us to the net result, which was DKK217 million, compared to DKK99 million in Q1 2014.

Finally, on this slide, our cash position. This increased by DKK285 million in the first quarter, mainly due to income from warrant exercises. This resulted in a cash position at the end of the quarter of nearly DKK3 billion.

Moving on to Slide 6 and the revenue, this slide shows the breakdown of revenue by category and a bridge between the two periods. In Q1 2015, the largest portion of the revenues was deferred revenue from our partnerships with GSK, Novartis, and Janssen at DKK73 million. In Q1 last year, milestones were the largest category and we recorded a large milestone from our daratumumab collaboration with Janssen of $22 million, or the DKK119 million that you can see on this slide. As previously discussed, milestones will be lumpy quarter to quarter and year to year. And although there were no milestones in Q1 2015, as Jan mentioned earlier, we did achieve a $10 million milestone for daratumumab in April 2015, and that of course will be recorded in Q2.

At DKK22 million, the Arzerra royalty was DKK6 million lower in Q1 this year compared to Q1 2014. As anticipated, sales was negatively impacted by increased competition in the CLO market. We look forward to working with Novartis to complete regulatory filings for both relapsed and maintenance CLL and hopefully widen the label for Arzerra going forward. Also, you can see on this slide the cost reimbursements to Genmab were lower compared to last year, as Janssen is now executing all of the new daratumumab studies.

Next, the expenses and the operating income on Slide 7. The graph on the left shows the change in expenses between Q1 2014 and Q1 2015. As you can see, the reduction was due to lower development expenses relating to ofatumumab and daratumumab. As mentioned earlier, Janssen are running and paying for all of the new and more expensive daratumumab trials. And for ofatumumab, as part of the transfer to Novartis, we no longer have to contribute to the development cost of ofatumumab.

Ofatumumab accounted to DKK44 million of the reduction shown here. The ofatumumab savings will be invested in strengthening our pipeline, and you've already seen new projects this year following the deals with BioNovion and the DR5 target that we acquired from iDD.

Looking at the chart on the right, you can see a significant increase in the operating income to DKK173 million largely due to the reversal of the GSK liability.

Now let's discuss the guidance on Slide 8. We are reiterating our guidance which was updated on March 11 to include the cash received from the March 2015 warrant exercises. There were no other changes to the guidance.

This slide shows the overview of the 2015 guidance compared to the actual result for 2014 and 2013. The revenue range for 2015 remains at DKK650 million to DKK725 million and includes projected daratumumab milestones of DKK180 million to DKK240 million. As a reminder, the daratumumab milestones are associated with clinical progress and assumed regulatory filings but do not include any commercial milestones. Arzerra royalties of DKK125 million have also been included in the revenue guidance, so we do need to see a pickup from the DKK22 million recorded in Q1.

We expect the operating expenses for 2015 to be between DKK600 million and DKK650 million, a growth is 7% at the midpoint of the range compared to 2014. The operating result guidance is a range of DKK200 million to DKK275 million, or a midpoint of DKK238 million. And that would be a small decrease of DKK27 million from 2014, although we will of course work hard to try and achieve the top end of the range, so that we can still beat 2014. Again, the operating result includes the reversal of the GSK liability of DKK175 million, or in fact it came out finally at DKK176 million.

We expect our year-end cash position to be in the range of DKK2.6 billion to DKK2.7 billion, including the March warrant exercises but not including any further exercise receipts.

Also note that, as usual, the 2015 guidance does not include any new potential deals although the recent deals that were announced have been absorbed into our current guidance.

Now back to Jan to discuss our 2015 goals.

Thank you David. Let's move to Slide 9 now.

Our goals for this year are focused on our marketed and late stage clinical products, advancing our pipeline, and making progress with our next-generation antibody technologies. We will continue to focus on maximizing daratumumab's progress through clinical development and have already announced positive pivotal data which may result in regulatory filings.

Together with Janssen, we intend to start new studies in multiple myeloma and begin to make clinical progress in other disease indications. With ofatumumab, we announced positive data from the Phase III study in relapsed CLL, and our new partner, Novartis, will discuss the potential for regulatory filings in this indication with health authorities, as well as working on a potential filing for our label expansion in the maintenance setting.

We continue to build our pipeline by progressing the Phase I study of HuMax tissue factor ADC, and for reporting progress on other preclinical programs. In fact, we will present the first clinical data for the HuMax tissue factor ADC program at ASCO in addition to preclinical data on HuMax-AXL-ADC, five presentations on daratumumab, and one on ofatumumab. We expect to enter new collaborations for both DuoBody and HexaBody technologies.

Finally, we will remain focused on controlling our financials so that we selectively invest in our pipeline to ensure we can effectively reach our goal of becoming a sustainably profitable company.

Let's move to Slide 10. That ends our presentation of Genmab's Q1 2015 results. Operator, please open the call for questions.

Thank you. (Operator Instructions). Michael Novod, Nordea.

Yes, hello. It's Michael Novod from Nordea Markets in Copenhagen. Just two questions, one relating to Arzerra. Now you've seen Novartis having the asset for I'd say a month or two. Maybe you could just elaborate a bit on whether you see any difference in traction and difference in how they, say, nurse the asset, just to see whether it's actually realistic that they will see a pick-up in royalties going through 2015.

And then secondly to Arzerra, maybe you could -- I know it's very, very difficult, but maybe you could put a bit more flavor to the initial comments. You have already now discussed this with US and EU authorities. So what is actually, say, holding back further communication on potential filing, and when do you expect, in terms of timing, that we should be able to hear more around ASCO, or should we expect it to go later into the year? Thank you very much.

Thanks, Michael, for the questions. First, let's start with Arzerra. We are very enthusiastic about the initial interactions with Novartis. We had our first meetings, Michael, but it's still in the starting-up phase. I mean the teams are being put in place. They are very encouraged by the positive data, strong positive data, in the ofatumumab Phase III trial that's read out recently. It will be presented at the medical conference pretty soon. I think that has further stimulated the enthusiasm.

But I would qualify the starting-up phase right now, the initial interaction is very, very positive. We have now met with them in person with the team in East Hannover end of April. I think it will take a few months to get everybody up to full speed because there's a lot of changes as you can imagine. But the tone is very, very good. Also, Novartis does have some very good targeted small molecule inhibitors that are basically begging to be combined to the CD20 antibody for treatment of B-cell cancers like CLL. And the more data we see from Arzerra, the more we become encouraged that this actually is a pretty good asset. And Novartis is a fabulous cancer company with a very robust expertise and a strong sales force.

So I would say that it will take some time to get everything up to the maximum level, but the first indications are very, very positive and so are the interactions we have with Novartis on our DuoBody platform. That is also going very, very well, and probably more news on that during this year.

Then move over to daratumumab. We are highly excited about the assets. The clinical data is very, very strong, which we have already signaled to the market before. We are very enthusiastic that ASCO has picked this data to be featured in a press briefing on Saturday, May 30, as I said. We had very positive and productive interactions with both US and European authorities up to this moment. But there will be lots of news in the coming months. Probably the first time that you will probably hear more about that May 20 R&D day from Janssen, but it certainly will focus on data and definitely ASCO and around ASCO there will be further update, I believe. But that needs to be aligned and coordinated with Janssen. They still need to take some of these internal decisions but that's all I think well on schedule and in the coming time, you can expect to hear more on the progress for next steps with daratumumab. But the interest level has gone up and not down as of the interactions with the regulatory authorities. That's probably all I can say about it at this time.

That's fine. Thank you very much.

Richard Parkes, Deutsche Bank.

Hi guys. Just got a couple of questions. Just firstly on the dara filings, I'm assuming that you've had the meetings with the regulators but you're just waiting for the notes to come back from those meetings. Obviously, it sounds like they've gone positively. If you walked away from either of those meetings feeling that a filing wasn't likely to be recommended, I'm assuming you would've had to change the guidance. I just kind of hypothetically wanted to confirm that sort of scenario.

Then on the guidance, it's obviously implying a significant uptick in expenses as we go through the year. Just wondering if you could discuss how much of that is sort of the investment in fixed cost, as it were, in terms of your own sort of preclinical and clinical work and how much of it is maybe milestones or payments that you're expecting to make as part of collaborations. So yes, I'll just leave it at those two.

Thanks Richard. Let me see what I can say more on filing time line. Today, there's no further updates, but I can tell you that we have very productive interactions with the regulators. And yes, we would probably have selected something to the market. We would not intend to file this year in both territories. The milestones for filing in both the US and European Union are in our current guidance, and we would likely have changed that. So I think your assumption there is probably right. I cannot say, give any further details. Probably the next time will be around ASCO and also probably the R&D day from Janssen we'll give further flavor with regard to dara pipelines etc.

Then with regard to the guidance, I will definitely ask David to give further input but I will briefly say something on how we actually decreased the expenses, and that by selectively accelerating very, very exciting components in our own preclinical pipeline. You were asking also about potential payments to partners like we did with iDD for the DR5 assets. It is probably a combination of both. And David can give you further color on that, Richard.

Very Good. Thank you. Thanks, Jan. Thanks for the question, Richard. Yes, it's fairly low expenses of DKK110 million in the first quarter when you look at the full-year expectation of DKK600 million to DKK650 million. And what we have always said before is look, we are getting the savings from ofatumumab, but we are reinvesting those savings. So it's really a timing phasing issue as we go throughout the year. But clearly if you take sort of four times Q1, you're going to end up at DKK440 million, but our expectation is to still be at around that mid-point range there of around DKK625 million.

The items that are really going to be the big drivers of the increased expense in the next three quarters, the biggest one by far, and that is about probably a third of the uptick that we need to get to reach that guidance number, is tissue factor ADC. That's going to get more expensive this year. Assuming things continue positively with the current Phase I trial, then we will be looking to expand the current existing trial, add more patients in, and then also look to design and to start new trials as well. The other big item of expense there will be additional CMC or materials to actually run those clinical trials as well. So that's the largest driver of the phasing and increased expense in 2015.

The next largest one is probably AXL-ADC. You've heard us talk about that one before as an expectation for AXL to be into the clinic next year to file the IND in 2016. So there's a lot of prework goes in the year before the IND, particularly again on CMC, on toxicology and other R&D preparation. So that's probably the next largest one in terms of a driver.

And then we've got our new programs working with BioNovion and sharing the cost there, and then our new asset that we acquired from iDD to really start working at a high pace on DR5. So those are probably the largest items that will drive most of that increase, so that's where most of it comes through.

When we are looking to acquire programs in, often they go onto the balance sheet and then we get the amortization, so there is an increase in amortization coming throughout the next three quarters as well based on some of the acquisition of those assets.

Perfect. Thank you very much.

Sarah Potter, Bank of America.

I have four questions please. Firstly, could you run through which studies you might be able to include in the potential filing package for daratumumab? Would it just be the double refractory data or would you be able to supplement the file with the early combo and mono data that you've shown to maybe get that on the label as well?

Second question on the sub-cut of dara. I can see you're starting Phase Ib in the third quarter of this year. Could you remind us of the route to market for this product, for example if Phase III studies are needed, and what the timing might be for this reach in the market?

Thirdly, just an update on the recruitment of the Phase II studies and when we may expect the first PFS data for dara.

And then finally, could you give us a little bit of color on which Phase III studies you've included a maintenance analysis in the study? I can see you've mentioned that in your report, but you didn't highlight which studies. An update on that would be great. Thank you.

Thanks for the questions. Let me give you further guidance of what will potentially be included in the first regulatory filings. It's definitely the Phase II study in the brachytherapy population in the double refractory patients. Then for sure, both safety and efficacy data of the early -- of the first Phase I/II study, the very first study with the daratumumab monotherapy. And then likely safety data from both the Phase Ib multi-combo study which is the three Velcade based regimens as well as the pomolid's dextera based regimen and the rough dextera Phase I/II study which is a 48 patient study. Also the safety data from that study will likely be included in the first regulatory filing. So, it will be a pretty comprehensive filing involving at least 250 patient data.

Then the sub-Q data, we have not publicly reported the exact scenario, but they are fully worked out now. It will definitely involve a Phase I study comparing the sub-Q with the IV formulation in multiple myeloma patients. That will start in the second half of this year. All preparations are geared up towards that and that will likely be followed by a Phase III study which can then lead to a label for the sub-Q formulation.

We haven't further guided for timelines, because I believe we are still discussing with the authorities the exercise of a potential Phase III study, so we cannot give any further color there.

Then moving to your third question, the Phase II studies, there will be further updates on combination data of the rough Dex Dara Phase I/II study at ASH this year. Also the Phase Ib multi-combo study, it has the three, Velcade, dara combination regimens, dosing regimens, as well as the Dex Dara on that Dex Dara arm which was originally six patients, then moved up to 12 patients, then moved to 50 patients, has now been increased to 100 patients, and very likely more than six months data from a large number of those plum Dex Dara patients will be updated at ASH. So we intend to give further updates on the combination regimens at ASH. And that may also conclude the early PFS indications for the monotherapy study. The original study, the Phase I/II study that started in 2008 was the dose escalation study with daratumumab. I can assure you that a very sizable number of patients on the 60 milligram per kilogram, those cohorts are still on treatment as we speak. With dara, you may get updates probably around the ASH timeframe on that study as well. But ASCO will focus almost exclusively on the Phase II study in the brachytherapy population because that is likely to be the first pivotal study which can lead to an application for a label.

Then with regard to the Phase III studies with maintenance components, actually several of the Phase III studies have maintenance components in it, but the most I think important is the VTD study, Velcade thalidomide dexamethasone Dex Dara which has not yet started up. It's an over-1,000 patient study, but that study has a very clear maintenance arm of more than two years built-in, which can also lead to maintenance type regulatory applications. So several of the other topline Phase III also have maintenance components of two to three years treatment in it.

Perfect. Thank you very much.

Thomas Bowers, Danske Bank.

Yes, just a few questions for me. Just off, sort of a follow-up on the ASCO and the R&D data. I'm just a bit curious whether we should expect potential updates on the Len Dex combination trial. I'm primarily thinking about the antibody interference that we've seen also presented in connection with ASH, so given the number of complete responders. And also in that sense in the detailed data to be presented at ASCO on dara, the mono trial, I'm just wondering. Will those potential CRs, will that be adjusted for this interference or not adjusted, so E sort of know what to aim for.

And then just very briefly on the Janssen and BioNovion collaborations, actually primary the Janssen deal, is there anything that has -- is that still progressing as planned, or are you just moving on with the BioNovion? Thank you.

Thanks Thomas. At ASCO, we will focus on the monotherapy study in the brachytherapy population because that is the absolute key part of the potential first regulatory filing. And I believe that right now, Janssen is not scheduled to give updates on the dara Revdax Phase I/II study. That data will actually come at ASH, which will be much more robust, substantial data.

What I can tell you is that, in all the studies, we have now made the corrections for the interference in the immunofixation electrophoresis assay. There will be preclinical data on that interference correction in that assay presented at ASCO, and that will be preclinical data. There may be some patients that this will be flagged up as examples of how a very good partial response can actually move up to complete response. But the full update of the Revdex dara trial will likely be slotted for ASH later this year in December. That is a choice just keep life a little bit simple for us because people start confusing different trials, we know. And so monotherapy will be the focus of ASCO. Combination therapy, which is likely going to be the biggest market for dara going forward will be at ASH, which is the biggest, most influential hematology conference. I cannot probably say anything further on that now.

Can I just ask, because it wasn't regarding any more mature dates. I'm well aware that will likely be at ASH. But it was just the data that we already had presented at ASH from the Len Dex trial whether those will be corrected with -- given that you now have updated data from the antibody interferon integration.

Absolutely. That data is going to be corrected for sure and will move up to what's more deep responses for sure as already factored by Torben Plesner at our Post-ASH seminar in San Francisco. But you will only hear about it at ASH and no longer this year. So you have to wait another six months.

Okay.

Unfortunately, but that's decided I think by our colleagues at Janssen, and that would be the scenario. But it will be corrected for sure in a positive sense, I can also tell you.

Then with regard to the immuno-oncology collaborations with BioNovion and Janssen, right now the BioNovion collaboration is most of our capabilities right now at Janssen is still working with both, for sure with the DuoBody technology, but also interest in other technologies, but that's a research collaboration. And that may or may not progress into commercial license interaction. That has not yet taken place. So most of the activity right now is in BioNovion. We are working on five active programs, as the BioNovion website clearly states, and these are all key immune checkpoints we are creating by specific antibodies as we speak. Genmab now has a robust robotized technology which allows us to create more than 1,500 biospecifics every 24 hours basically in a completely automated fashion so we can really optimally select unique candidates which has the most optimal profile. And the colleagues at BioNovion are wonderful experts in the immune checkpoint area. They have a lot of expertise with PD-1. They developed pembrolizumab while they were still at Organon, which is now part of Merck, Keytruda, and they really know how to play in that field in a very -- I would say very clever way. And together with scientists from Genmab, we are now creating several product candidates against unique target combinations. But BioNovion is far higher activity as we speak than at Janssen but also Janssen is very actively testing out the DuoBody technology platform in-house. I cannot say anything further on that.

Perfect. Thank you.

Peter Welford, Jefferies.

Thanks for taking my questions. I've got two left. Firstly, just with regards to the Lilly collaboration, or research collaboration I think it was, that's concluded I think you said during not this quarter but May. I presume, from that, that has concluded and there is no further progress of any programs going forward from that? I just wanted to check if I understood the wording of that correctly.

And then just returning to dara a minute and the sub-cut formulation. I guess I'm just curious. The Phase Ib, is this likely to be a head-to-head sort of looking versus the IV formulation, or how would you structure a Phase Ib I guess for this, given obviously the drug isn't yet approved and we haven't got any sort of data from the later stage patients -- from the late stage trials, sorry. So I am just sort of wondering how at this sort of early stage Janssen can best proceed with that formulation to obviously get extracted to the market. Thank you.

Thanks, Peter, for the questions. Let me first start with the Lilly research collaboration. I can tell you that Lilly has evaluated DuoBody platform in-house, and they are highly interested in the DuoBody platform. At this moment, however, Lilly doesn't have a suitable project for a specific approach which would need a commercial license, so they have not moved at this moment to a commercial agreement with Genmab. But they remain very enthusiastic, so there is still very active interaction between Lilly and Genmab scientists. And I think this may very well in the future develop into a commercial agreement very much like we did with BioNovion. You start off with a research collaboration and then it develops into a commercial license interaction. But it also depends on of course on the product candidates, which have already been created in the sense of antibodies against interesting targets.

So Lilly right now is not active commercially, and research interaction has ended because it has certain finite time, but they remain highly enthusiastic. And this may very well pop up at some point later.

So then with regard to daratumumab, the Phase Ib -- Phase I study, this is being written up right now. It will work in that we will indeed compare the sub-Q formulation in MM patients with the IV formulation. The doses have already been determined, and we will primarily look at PK and PD. If we actually see a good profile with the sub-Q formulation and good depletion of the tumor cells, and good clinical responses to the sub-Q formulation, that can straightforwardly move into a Phase III trial. Also that trial, as I already described before in the Q&A, has been written up and has been designed, but I believe there still are some discussions with the authorities presently on exactly how the powering and the size and so on of the Phase III trial will have to be designed. It's too early to comment upon. The second half of this year, we will start with the Phase I. And we expect it to be very quickly because what we see up to now is that all the trials for daratumumab recruits a lot more rapidly than even our most optimistic projections. So you can expect updates on recruitment rates once we see finished recruitment in a number of the trials, especially the Phase III. We'll report it back to the market via our quarterly update. So we hope to keep these type of calls interesting. It's relevant information. But with dara, everything seems to be progressing well ahead of schedule and that continues to be the case.

That was actually, if I can, a follow-up question on that. The VMP milestone in April for the Acyclone, or however you pronounce it, trial. Is that -- obviously that was $10 million. Hypothetically, what sort of events could we think of that could trigger that sort of milestone other than completion of recruitment? Thank you.

We have not exactly described to you how exactly the milestones are being defined, but most of them are defined either for clinical progress or for concrete steps, for example the filing or of course commercial milestones later on. So further progress in clinical studies in different indications will likely trigger further milestones. I cannot give you any further color there.

Thank you.

Sachin Soni, Kempen.

Good afternoon everyone. My question is regarding should we expect some updated efficacy numbers in the abstracts tomorrow night?

And the second question is regarding the potential label you could get with the upcoming filing. As you mentioned, you're submitting a lot of data from other trials as well. What kind of label are you expecting? Is it going to be narrow or do you have a chance to get a slightly broader label than just the efficacy indication you have?

And lastly, how do you see the positioning and maintenance at the launch when it's compared to alituzimab? Thanks a lot.

Thanks, Sachin, for the questions. Updated efficacy data, I mean for daratumumab for the Phase II trial, this is absolutely key. You will not see an abstract tomorrow evening. We apologize for that. But that's up to the wisdom of ASCO, pointing out this -- selecting this abstract as a latebreaking abstract. So you have to wait until May 30 until the press briefing from ASCO for further data. I cannot tell you what type of data it will be, but will definitely give you more insight into the type of patients treated with daratumumab. You know that they all fit into the brachytherapy category, so at least three lines of therapy, one line involving an image, another line involving a proteasome inhibitor or double refractory 2 combination of an IMiD and proteasome inhibitor. But what you of course will want to see is since this was primarily a US clinical trial with over 90% of the patients treated in the United States, you want to of course know whether they were being treated with Pomalyst or with carpolis already before. But that type of data will only become apparent on I believe May 30, and also further information. It will be very important on the depth of the responses, because you have not heard anything of that. But you can sense from my optimism and hopefully also you will soon hear about Janssen's optimism at the R&D day that the data is very, very strong, we believe. So other data from other abstracts will certainly contain data on efficacy of compounds, and I think you can hopefully see from abstracts, like the tissue factor ADC abstract, some encouraging efficacy information as well as the ofatumumab abstracts that will be presented. This will contain data on efficacy together with idelalisib, which is a study by Gilead. So definitely efficacy data there, but updates on dara, you have to wait May 30 for that.

The second question is actually with regard to the label. From what I described to Sarah, you can conclude the study actually included a lot of data. We will definitely try to get a broader label, and the end is of course up to the authorities to see what they grant us. But what we have seen in the daratumumab is the drug is very, very active in all the settings, both in monotherapy as well as in combination therapy. But of course it is up to the decisions of the regulators about the breadth and the strength of the label. But I can assure you that Janssen is a phenomenal development partner with a lot of expertise in the multiple myeloma therapeutic space and they will try to get an optimal label. I cannot give you any further comments on that.

Then positioning, the third question with regard to Elotuzumab, Elotuzumab has -- is only a trial where we may actually see more data on at ASCO in combination with Revlimid. Dara will initially be launched as a monotherapy, because that will be the first set of data which will be submitted to the authorities. So the positioning will be different. I mean dara will be in a different line of treatment than Elotuzumab will likely be positioned there. But we have not seen any Elotuzumab pivotal data.

What we do know is that Elotuzumab has no monotherapy efficacy, and also there is some very interesting data, together with the proteasome inhibitors, which is endobalming, together with Elotuzumab we have seen some very strong data of that both at proteasome inhibitors as well as with IMiDs, which is, we believe, far stronger than comparable data with Elotuzumab. So we have to see how the ultimate positioning will be in the labels of daratumumab versus Elotuzumab, but we right now believe that daratumumab has the potential to be positioned as a backbone therapy at all the lines of treatments of multiple myeloma in the future, but we of course will have to collect good data. But the initial hints are that it is a very, very active drug, so we continue to be very optimistic about the potential of daratumumab. And I hope you can share some of that optimism in the future.

Sounds good. Thanks a lot.

There are no further questions at this time, sir.

All right. Thank you for calling in today to discuss Genmab's first-quarter 2015 financial results. We look forward to speaking with you all again soon.

Thank you. That does conclude our conference for today. Thanks for participating. You may now all disconnect.