MorphoSys AG (MOR) 2017 Q3 法說會逐字稿

Ladies and gentlemen, welcome to the MorphoSys Quarterly Results Conference Call. (Operator Instructions) Now I would like to turn the conference over to Anke Linnartz. Please go ahead.

(technical difficulty) 2017 Conference Call and Webcast. My name is Anke Linnartz, Head of Corporate Communications and Investor Relations at MorphoSys. With me on the call today are Simon Moroney, our Chief Executive Officer; and Jens Holstein, our Chief Financial Officer.

Before we start, I would like to remind you that during this conference call, we will present and discuss certain forward-looking statements concerning the development of MorphoSys' core technology, the progress of its current research and development programs and initiation of additional programs. Should actual conditions differ from the company's assumptions, actual results and actions may differ from those anticipated. You are, therefore, cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof.

In the presentation, Simon will start by giving you an operational review of the third quarter as well as an outlook for the rest of this year. After that, Jens will review the financial results of the third quarter and the first 9 months of 2017, before we will open the call for your questions. You will find a slide deck of this presentation on our corporate website.

I would now like to hand over to Simon Moroney.

Thank you, Anke. And also from me, a warm welcome to our Q3 call. The third quarter of 2017 and the few weeks following the end of the reporting period has been eventful and exciting for all of us at MorphoSys. There were 2 major highlights. The first came in July with FDA approval of our partner Janssen's Tremfya, guselkumab, in psoriasis and the subsequent U.S. launch of the drug. As we speak, we're waiting for the first royalty payment from Janssen. The second highlight came just 2 weeks ago when we received Breakthrough Therapy designation from the FDA for our lead compound, MOR208, for the treatment of relapsed/refractory DLBCL in combination with lenalidomide. Both events marked significant inflection points on our way to becoming a commercial product-based biopharmaceutical company: First, the guselkumab approval by providing product-based revenues, which we expect to increase substantially over the years to come; and second, the Breakthrough Therapy designation by offering us a means to bring MOR208 to market as quickly as possible.

Aside from guselkumab and MOR208, we've been seeing significant progress in our pipeline during the quarter. Overall, at the end of Q3 2017, our pipeline comprised a total of 113 investigational programs, 28 of which were in clinical development. 5 out of these 28 clinical programs are from our Proprietary Development segment, and I'll start the review with a closer look at these programs.

First to MOR208, our investigational Fc-enhanced CD19 antibody, the most advanced of our in-house programs. As a reminder, we're currently investigating MOR208 in two indications, namely relapsed/refractory DLBCL and BTK-inhibitor refractory or intolerant CLL and SLL.

The main focus of the development program is currently on relapsed/refractory DLBCL, where we're seeing particular encouraging results. The priority for the organization is to find the fastest path to market for MOR208 in this indication. Two studies have been conducted in DLBCL, namely the L-MIND and B-MIND trials, both are focusing on relapsed or refractory DLBCL patients who are not eligible for high-dose chemotherapy with subsequent autologous stem cell transplantation. For this group of patients, the available therapy options are currently very limited. As you remember, for our open-label Phase II L-MIND trial of MOR208 plus lenalidomide, we presented very promising preliminary results from the first 44 patients, 34 of whom were eligible for efficacy assessment at that time at ASCO. On an intent-to-treat basis, the data presented showed an objective response rate of 56% and a complete response rate of 32%. Although preliminary, these response rates are highly encouraging, especially when the dismal prognosis for these patients is considered.

Many of you would have seen the ASH abstracts, which were published last week, in which we highlighted a median progression-free survival of 11.3 months in this ongoing study. This preliminary PFS is particularly significant in our view, and was probably one of the main reasons we were granted Breakthrough Therapy designation by the FDA. Median PFS in this setting is typically substantially shorter, so we have first evidence that MOR208 could provide a real clinical benefit here. We're now focusing all our efforts on working closely with the FDA so as to make MOR208 a new treatment option for patients with high unmet need as quickly as possible.

In parallel, we've been driving the study forward with full speed and recruitment is ahead of forecast. As we speak, we'll complete enrollment of the projected 80 patients shortly. We'll provide an update from the L-MIND trial and a poster presentation at this year's ASH conference in December. We will provide an update from the -- the data will be based on 51 patients enrolled, 44 of whom are eligible for efficacy assessment, and will be based on the same cut-off date that we had used for the application to the FDA for the Breakthrough Therapy designation.

We're also going to have a separate conference call for analysts and investors after the ASH meeting, where we will walk you through the data and provide some strategic insight and outlook with respect to the MOR208 program.

B-MIND, the other clinical trial with MOR208 in relapsed/refractory DLBCL, is making good progress as well. The study is comparing MOR208 in combination with the chemotherapeutic agent, bendamustine with rituximab plus bendamustine, and progressed into its Phase 3 part in June of this year. We currently expect an interim analysis of the trial in late 2018 and a primary endpoint readout in the first half of 2020.

The interim analysis is event-driven and will be performed when 50% of the progression or death events required for the final analysis have occurred. The purpose is twofold: First, to check the necessity for potential increase in number of patients to be enrolled to be able to draw solid statistical conclusions at the end of the trial; and second, to check for futility.

In addition to the 2 combination trials in relapsed/refractory DLBCL, we're evaluating MOR208 in the Phase II COSMOS trial. This trial is looking at MOR208 in combination with idelalisib or venetoclax in relapsed/refractory CLL or SLL patients after discontinuation of a BTK inhibitor therapy. The study is progressing well and is investigating the clinical safety of the treatment combinations. We plan to submit the first data for presentation at one or more major medical conferences in 2018.

I'll turn now to MOR202, our investigational anti-CD38 antibody. Patient enrollment for the study has now been completed. Everything we've seen since we presented updated safety and efficacy data from the ongoing study in relapsed/refractory multiple myeloma in June at ASCO confirms that MOR202 has an efficacy profile comparable to competitive compounds and shows a significant advantage with respect to safety, tolerability and convenience. Beyond multiple myeloma, we've seen intriguing preclinical findings, highly supportive of an anti-CD38 approach in other therapeutic fields, including solid tumors and autoimmune diseases. These results hint at wider fields of application for MOR202.

As we've said previously, we feel that this program is best pursued together with a partner. We're in discussions and are confident that we can achieve an outcome, which will enable us to extract the full potential of this molecule.

On the subject of CD38, we'd like to give you an update on the patent situation. In the litigation before The United States District Court for the District of Delaware, we received a ruling from the second Markman hearing 3 weeks ago. We're very pleased with the outcome. The court agreed with all of our constructions for certain term claims of U.S. patents 8,263,746 and 9,200,061. The court construed the claims at least five or twofold better efficacy, isolated and binds an epitope of CD38 that contains 1 or more amino acid residues within 192 to 206 of sequence ID number 22 in accordance with our view. We believe that daratumumab infringes 3 granted U.S. patents owned by Morphosys, and this recent ruling on claim construction further strengthens our view. We're seeking financial compensation on sales of daratumumab.

I'll turn now to MOR106. This is the investigational antibody from our Ylanthia platform directed against the IL-17C, which we're currently developing with our partner, Galapagos. At the end of September, we announced first results of a Phase I clinical study with MOR106 in healthy volunteers and in patients with atopic dermatitis. MOR106 was generally well-tolerated in the trial and demonstrated promising signs of clinical efficacy of the highest dose. This supports its progression into the next clinical stage. And together with our colleagues at Galapagos, we're currently finalizing the design of a planned Phase II study. In September, following a review of our development portfolio, we decided to terminate our collaboration with Aptevo Therapeutics for the development of MOR209 in prostate cancer. The program was in Phase I development, and the rights to the drug's developments and commercialization have been returned to Aptevo.

Turning to MOR103, or as it's now called GSK3196165. Our partner GSK is currently evaluating this investigational anti-GM-CSF antibody in 3 clinical trials: A Phase IIb study in patients with rheumatoid arthritis; a phase IIa biomarker study in rheumatoid arthritis; and a Phase IIa study in patients suffering from inflammatory hand osteoarthritis. According to clinicaltrials.gov, the trial is scheduled for primary completion towards the end of this year. We look forward to learning the results.

To close out this part of the presentation, our Proprietary Development segment comprises 13 therapeutic programs, 5 of which are in the clinic, and 1 of which, MOR103, is out-licensed to GSK.

I'll turn now to our Partnered Discovery segment. We believe that this segment comprising dozens of product candidates in development will be an extremely lucrative royal-based revenue generator for MorphoSys in the years ahead. The approval of guselkumab represents the tip of an iceberg that will be an enormous source of value for the company in the future. We're looking forward to learning about the launch of guselkumab. But at this time, we've not yet received our first royalty report from our partner, Janssen. As Jens will explain, that's why we cannot give guidance regarding royalties we can expect on this product. But overall, we feel that guselkumab has the potential to be a very successful drug in psoriasis as well as other indications and, therefore, a major source of revenue for us.

A further positive event came in mid-September when the CHMP Committee of the EMA recommended the approval of guselkumab in moderate-to-severe plaque psoriasis in Europe. We expect the approval decision by the European Commission before the end of the year. Also in September, we announced that Janssen has initiated 2 new Phase III clinical studies with guselkumab in psoriatic arthritis, thus further expanding the potential therapeutic scope of the drug.

Overall of a total of 100 programs, 23 of which are in clinical development, our Partnered Discovery pipeline continues to progress well. There's a lot of near-term potential news flow from this segment. In the remaining months of the year, according to clinicaltrials.gov, 19 studies conducted by our partners are due for primary completion. As always, we have no control over what and when our partners communicate, but we aim to inform you of progress as soon as we learn about it.

Before I hand over to Jens, I'd like to mention a recent change in management. Dr. Markus Enzelberger has been appointed Chief Scientific Officer as of November 1, 2017. Markus has been the company's interim CSO since April 15 of this year, and succeeds Dr. Marlies Sproll, who has been on temporary leave from her CSO position for family reasons since that date. Marlies resigned effective October 31, due to ongoing family matters, and has now taken on a new part-time role at MorphoSys as special adviser to me.

On behalf of the entire Management Board, I'd like to thank Marlies for all her incredible service and contribution to MorphoSys over the past 17 years. And we're very happy that we were able to keep her and her expertise available to the company. Markus has been with the company since 2002, being responsible for our own and our partners' discovery activities and our technology development. He's a fantastic scientist and one of the industry's leading experts in our field. My colleagues and I look forward to working with him to advance the company's platform and product portfolio.

With that, I'll hand over to Jens for his wrap-up of the financials.

Yes, thank you, Simon. Ladies and gentlemen, also from my side, a warm welcome to all of you, and thank you for your interest in the company. Let me kick off the financial section with an overview of the most important financial figures for the third quarter and the first 9 months of 2017.

Starting with our P&L statement on Page 11, you can see that in Q3 of 2017, group revenues amounted to EUR 15 million, up 20% compared to EUR 12.5 million in Q3 of 2016. The revenue increase was mainly driven by license income and milestone payments of Janssen. It has been reemphasized that Q3 revenues do not include royalties on Tremfya sales as the first royalty reporting from Janssen has not been received yet.

Last royalties on Tremfya, guselkumab, the sale for Q3 2017 since launch in late July 2017 will be in part of Q4 2017 results. Total operating expenses increased by 49% to EUR 38.2 million in Q3 2017. The expenses thereof for research and development amounted to 31 -- EUR 34.1 million as compared to EUR 22.1 million in 2016. As planned, we spent more than -- more on clinical development for our proprietary drug candidates than last year. Three Phase II studies started with our lead program MOR208 in selected blood cancer indications during 2016, one of which transitioned into a Phase III clinical trial in Q2 of 2017. In addition, general and administrative expenses increased to EUR 4.1 million from EUR 3.4 million.

As anticipated, our earnings before interest and taxes, the EBIT, came in at minus EUR 23.5 million for the third quarter of 2017 in comparison to minus EUR 13.1 million in Q3 2016.

Our consolidated result after taxes in the third quarter of 2017 amounted to minus EUR 24 million compared to minus EUR 12.8 million in Q3 of 2016. The consolidated net result per share for Q3 2017 was minus EUR 0.83 after minus EUR 0.49 for Q3 2016.

Let's move to our segment reporting on Page 12 of the presentation. In our Proprietary Development segment, we focus on the research and clinical development of our own drug candidates in the fields of cancer and inflammation. For Q3 2017, the segment recorded revenues of EUR 0.2 million, after EUR 0.1 million in the corresponding quarter of last year. Compared to the previous year, our expenses for our Proprietary R&D activities were influenced by the write-off of MOR209. Expenses for Proprietary Development came in for the reporting quarter of EUR 30 million, an increase of 68%. As a result of this cost increase, we reported an EBIT of minus EUR 29.8 million after minus EUR 17.7 million for Q3 2016.

In the Partnered Discovery segment, we apply our proprietary technology to discover new antibodies for third parties. For Q3 2017, revenues in this segment reached EUR 14.8 million after EUR 12.3 million in Q3 2016. Correspondingly, the EBIT came in at plus EUR 10.4 million for Q3 2017 compared to EUR 7.7 million for Q3 2016.

To now briefly sum up the key figures for the first 9 months of the year 2017, please turn to Slide 13. Group revenues amounted to EUR 38.6 million, 5% higher than the EUR 36.7 million for the first 9 months of 2016. Again, royalties on Tremfya sales for Q3 2017 since launch in late July will be part of Q4 2017. As planned, total R&D expenses rose from EUR 58.8 million for the first 9 months of 2016 to EUR 80.5 million for the first 9 months of 2017. Thereof, R&D expenses for Proprietary Drug development, including technology development, increased to EUR 67.9 million for the first 3 quarters of 2017 after EUR 46.2 million for the comparable period of the previous year. This increase is to great extent the consequence of our intensified activities in the clinical development of our proprietary drug candidates that are transitioning into advanced development stages. Those activities require larger clinical studies. Hence, the EBIT in the first 9 months of 2017 came in at minus EUR 53.8 million compared to minus EUR 32.3 million for the 9 months of 2016.

Let's move on to the balance sheet on Slide 14. As of September 30, 2017, we recorded total assets of EUR 420.3 million after EUR 463.6 million at year-end 2016. At the end of Q3, we had a cash position of EUR 319.5 million compared to EUR 359.5 million on December 31, 2016. As a reminder for those of you that do not know the company that well, on the balance sheet this cash position is reported under the following balance sheet items: Cash and cash equivalents; available-for-sale financial assets; bonds available for sale; and current and noncurrent financial assets classified as loans and receivables.

The number of shares issued total 29,345,748 at the end of Q3 2017 compared to 29,159,770 at year-end 2016.

Before we open the call for your questions, we would like to reconfirm our financial guidance for 2017, which was published in March in connection with the presentation of our 2016 annual report. For the financial year 2017, we continue to expect group revenues in the range of EUR 46 million to EUR 51 million. R&D expenses for proprietary drug development and technology development are confirmed to be in the corridor of EUR 85 million to EUR 95 million. The guidance for earnings before interest and taxes, EBIT, continues to be in the range of minus EUR 75 million to minus EUR 85 million. As usual, this guidance does not include any additional revenues from potential future collaborations and/or licensing partnerships, nor effects from potential in-licensing or co-development deals for new development candidates.

As first royalty reporting from Janssen has not been received yet, royalties on net sales for Tremfya could not be accurately projected at this point in time. Hence, this guidance for the financial year 2017 does not include any royalty income in the sales of Tremfya. As previously communicated and as reflected in our guidance for 2017, the collaboration with Novartis will conclude at the end of November 2017 in accordance with the contract.

Before I hand back to my colleagues, I would like to reiterate that our portfolio is growing nicely, and most importantly, maturing year-over-year. We invest in the development of our own drug candidates going forward to grow the company's value. In particular, we will focus on the development of our blood cancer candidate, MOR208. Our goal is to develop MOR208 to the market as fast as possible, and we are hopeful for continuous

positive news flow. Also receipt of Breakthrough Therapy designation for MOR208 and the approval of Tremfya mark our transition to a product-based biopharmaceutical company, whose revenue will be increasingly based on recurring income from product sales in the years to come. We intend to reinvest those cash flows into the development of our proprietary drug candidates. We believe we have an exciting time in front of us, and are looking forward to report more news on the development of our compounds in Q4 and the quarters beyond.

Ladies and gentlemen, that concludes my review for the third quarter of 2017. And I'll now hand back to Anke for the Q&A session. Thank you.

Thank you. We would now open the call for your questions.

(Operator Instructions) The first question comes from the line of James Gordon with JP Morgan.

Couple of questions on MOR208, please. One is, looking at the abstract for the MOR208 data, it looks pretty strong in the abstract for ASH. We also saw some good data from Roche's polatuzumab vedotin. You had the stronger PFS, they had stronger ORR data. Just, which metrics do you think are more important? And is it all about PFS or does ORR matter? And to what extent do you think we can do really compare the data? Is it fair to say that the patients in your trials are less heavily pretreated, in that could it mean that if it's going to a direct comparison? And then just a final MOR208 question is just, in light of the Breakthrough Therapy designation, what is the earliest that you could potential follow on Phase II data as opposed to Phase III?

Thanks, James. Yes, let me take those 2 questions. First of all, regarding the 208 data versus Roche's ADC that you pointed out. And first of all, and this is a generally true statement, one should be extremely careful comparing data from different clinical trials. By necessity, one can't match patients, of course, because they're completely separate trials. And so one should be extremely cautious of comparing data between trials. We're very, very happy and very delighted about the data that we've generated. What we do know from this field is that there's not necessarily correlation between response rates and duration of survival. So in other words, between depth of response as measured by ORR or CR and duration of response is measured by progression-free survival. The more important metric we believe is progression-free survival. That's usually the most important primary endpoint, and certainly for us, the most important and the chosen primary endpoint in our trials. And if you think about it, that's what really counts for patients. And certainly our objective for 208 has always been to provide a treatment that is effective, that is as safe and well tolerated as possible, and can get patients into remission and keep them there for the long-term. And we feel very good about the data that we've seen so far. And that 208 has the possibility to become exactly such a treatment, which is sorely needed, one has to say, in DLBCL. Regarding your second question, will Breakthrough Therapy designation now enable us to file on the outcome of the Phase II study that's almost completed enrolling? That remains to be seen. So we're in discussions, of course, with the FDA on exactly that point. And it's too early as yet to say what the outcome of those discussions will be. But happily, the purpose -- the whole purpose of Breakthrough Therapy designation is so that the FDA can work as closely as possible with us to figure out what the best path forward to an approval is for the drug. So we hope to have feedback on that in Q1 of next year. Once we've had the discussions with the FDA and, of course, as soon as we've that information, we'll share it with you.

The next question comes from the line of Anastasia Karpova from Kempen.

Few questions, if I may, mostly on MOR208. In your early and preliminary discussions with the FDA, has the fact that lenalidomide is not approved in DLBCL, and probably will be approved in -- or potentially will be approved in untreated DLBCL been a proponent to any acceleration in the approval based on L-MIND study? And specifically for L-MIND study, do you have a possibility to change the protocol to increase recruitment on the trial side? As more of a semantic question, but is it true that you did make some progress in the discussions regarding MOR208 -- MOR202 partnership since you're not communicating that in Q2 results? Or it's just a rephrasing from the press release?

Thanks, Anastasia. Let me take those. But your line was not so great. I think I heard them, probably, but if I missed something, please let me know. Regarding lenalidomide in DLBCL, I think an important point to make here is that the Breakthrough Therapy designation is granted for the combination. So it's granted for the data that we've -- on the basis of the data that we've shared with the FDA, which is, of course, 208 plus lenalidomide. We know that lenalidomide on its own in the setting, in this relapsed/refractory DLBCL setting, does not do particularly well. But that's not really relevant to the Breakthrough Therapy designation, which is granted because in combination, 208 plus lenalidomide seems to work actually very well. So we're not sure that Len alone is relevant, which kind of leads into the second part of the question. I think you said, can we change the protocol of the current L-MIND trial? I think the purpose of the discussion with the FDA and what will be interesting is, what do we have to do in order to get to an approval for 208? In other words, can the existing 80-patient L-MIND trial be sufficient on its own? Or do we have to adapt it? For example, do we have to add additional patients to it? Do we have to add a control arm? Currently, it's a single arm trial, of course. These are all questions that we don't know the answers to, and which are the subject of exactly that discussion with the FDA. And as I said, as soon as we have reliable feedback from those discussions, we'll certainly share it with you. And the third question, I think, regarding progress on partnering of 202. Yes, there has been progress. But as always with these things, we don't comment on where things stand and who we're talking to and time line and so on and so forth. We prefer to focus on getting the best possible outcome in the interest of the program. And as soon as we are in a position to talk about the outcome of those discussions, we'll certainly do so.

And the next question comes from the line of Gunnar Romer from Deutsche Bank.

The first one would be again on MOR208. So I guess, that your confidence and interest from potential partners must have increased substantially on the back of the PFS data. So in this context, can you just quickly remind us of your main priorities now when it comes to partnering of the company, given that timelines are likely to accelerate? And then on -- second question would be on MOR202 and the patent litigation here, pleased to see that you have made further progress. How should we be thinking about further decisions, milestones and the final ruling in the months ahead? Any additional color on there would be super-helpful? And then last but not least, for Jens, regarding the cash position. Now that you have seen that impairment on 209, still maintaining the guidance corridor, I would believe that your cash guidance would probably slightly increase? Any update on that front would be super-helpful as well?

Thanks, Gunnar. Let me start with the 208 question. Partnering, we don't feel in any -- under any huge pressure to secure a partner for that program at this time. We are committed to both the B-MIND and the L-MIND trials. We're thinking very carefully and analyzing very deeply at the moment what commercial -- commercialization strategy for 208 could look like. We're reanalyzing some of the preliminary decisions we took earlier about where we could commercialize the program. This is, we feel, an ideal program for us to establish MorphoSys as a commercial entity around, and could be, we think, a real important value driver for us. So there is interest, of course, no surprise, given the strength of the data and the results we've shown in the ASH abstract, and we'll go into detail around at ASH. So there's certainly interest from potential partners, but we don't feel any particular hurry to partner the program. Regarding 202 litigation, kind of working backwards, if you remember, the trial is scheduled for early 2019. So that date got pushed back. You may remember it was originally in the summer of next year, but the addition of a third patent to that case has pushed the date of the trial back. So we now have a trial date in February '19. And leading up to that, of course, there are a series of four more steps that are normal procedure for our litigation before U.S. court. And so that's -- if we go all the way through the formal legal process, that's when you can expect the first decision at the trial in February of '19. Of course, whatever else could happen before that could happen, but that remains to be seen.

And then on the cash question, Gunnar, your expectation regarding a change in the cash position is correct. I would increase the former guidance that we have given out of EUR 275 million to EUR 285 million, by EUR 10 million, to EUR 285 million to EUR 295 million at year-end 2017.

Our next question comes from the line of Igor Kim of ODDO BHF.

I've got a couple of questions shortly on MOR208, during the ASH conference. Do you expect to give a bit more details regarding the confidence interval for the PFS? Or maybe update on that, could we expect that it's during the ASH conference and terms? Second question regarding Tremfya. In case it will be approved in Europe, let's say in November or sometime in December, can we expect as fast launch as we saw in U.S. within 2 weeks after the approval?

Thanks. Igor. Regarding the 208 question, yes, I'm sure that there will be a detailed presentation of the data, which I assume will include the information that you asked about there. So that will be a complete data presentation that you get at ASH. Regarding Tremfya in Europe, as we said, we would, under normal circumstances, expect the decision by European Commission here in November. And whether Janssen is in a position to launch as quickly as they did in the U.S., we simply don't know. You have to direct that question to them as to timing for potential launch in Europe.

We currently have no questions coming through. (Operator Instructions) The next question comes from the line of Mick Cooper from Trinity Delta.

Just one question, and I'm afraid, again, on 208. I was wondering what the impact of recruitment was in the various trials on the back of the data that you presented in the Breakthrough Therapy designation for 208?

Thanks, Mick. We've already had a renewed increased interest since presenting data earlier. We had a particularly successful event at EHA, The European Hematology Association, conference in June that sparked really a lot of interest. We had, I think, over 200 people show up to that Satellite Symposium there. So this program, MOR208 under the L-MIND, B-MIND and COSMOS trial, has already some time ago sparked interest in the community. And that's certainly one of the reasons why we're ahead of schedule on L-MIND. I'm very happy with the way it's going. And I think the Breakthrough Therapy designation has raised the profile of the program even further, but it's too soon to say whether that is having any impact on the rates of recruitment in the various trials. We're happy with the way it's going. It's a high-profile program. It's got a lot of attention, a lot of interest. And we're delighted by the way it's going.

The next question comes from the line of Thomas Schießle from EQUI.TS.

Actually it's one concerning on 107, so the first human study on dermatology. Could you shed a little bit light on the actual situation? And do you have any clue on the dose you might -- will apply in the next study?

Thanks, Thomas. Perhaps you're referring to more 106 actually, the IL-17C program together with Galapagos.

Indeed, yes.

So the planning for that Phase II trial is ongoing at the moment with our friends at Galapagos. And it's simply too early to say what dose we're going to go with at this stage.

Do you have any clue concerning the competition, which dose might be appropriate?

This is the only IL-17C antibody in the clinic. In fact, the only program as far as we're aware against IL-17C at all in clinical trials right now. So we've got nothing to go off other than that -- our own Phase I study, which will, of course, be a guide for us. So trying to read across from other drugs with other mechanisms doesn't really help us there. So it's really a case of looking at the data we have from Phase I, and the modeling data and designing the Phase II trial accordingly.

And commentary to the time frame.

As I said, we're currently planning the Phase II trial with Galapagos right at the moment. We're confident that, that will get going next year. I can't give you color on precisely when that will get going. But it is based on the encouraging data we've seen, which we're very happy about the Phase I data. But it's a priority for both companies. And so we're looking to push it forward as quickly as possible.

(Operator Instructions) We have no further questions coming through. So I will now hand back over to Dr. Simon Moroney to wrap up today's call.

Thank you. And to conclude the call, I'd just like to remind you of the main points to takeaway. First, MOR208. We'll use the momentum from the FDA's Breakthrough Therapy designation to focus on developing 208 plus lenalidomide in relapsed/refractory to approval as fast as possible. I'd like to remind you that data from the ongoing L-MIND trial will be presented at ASH in Atlanta on December 11 from 6:00 p.m. to 8:00 p.m. Eastern Standard Time as well as in our conference call for investors and analysts one day later, December 12, at 11:00 a.m. Eastern Standard Time. Further details on that will follow. MOR202, we're happy with progress on 202, both clinically and in terms of the work we're doing to secure the program's future. 106, we're excited about the potential of this compound based on the promising data we've seen so far. I look forward to working with our partners from Galapagos on further development. Guselkumab, Tremfya, will soon have insight into the U.S. launch, and look forward to approval in Europe. Altogether, it will be busy last few weeks of the year, and we look forward to keeping you informed of progress.

Thank you. That concludes the call. Please be reminded full year results will published March 13, 2018. I'd like to thank you for your support and for joining us today. Thank you. Goodbye.

Ladies and gentlemen, the conference is now concluded, and you may disconnect your telephone. Thank you for joining, and have a pleasant day.