MorphoSys AG (OTCPK:MPSYF) Q3 2017 Earnings Conference Call November 7, 2017 8:00 AM ET
Anke Linnartz - Head of IR
Simon Moroney - CEO
Jens Holstein - CFO
James Gordon - JPMorgan
Anastasia Karpova - Kempen
Igor Kim - Oddo
Ladies and gentlemen, welcome to the MorphoSys' Quarterly Results Conference Call. Please note that for the duration of the presentation, all participants will be in listen-only-mode. And the conference is being recorded. After the presentation, there will be an opportunity to ask questions. [Operator Instructions]
Now, I would like to turn the conference over to Anke Linnartz. Please go ahead.
Welcome to 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 technologies, the progress of its current research and development programs and the 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 overview 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 nine months of 2017, before we will open the call for your questions. You will find the slide deck for this presentation on your corporate website.
I would now like to hand over to Simon Moroney.
Thank you, Anke and also from me 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 in MorphoSys. There were two 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 are waiting for the first royalty payment from Janssen.
The second highlight came just two 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 of this marked significant inflection point 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.
The slide from Guselkumab and MOR208 is 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. Five out of these 28 clinical programs overall 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 are 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 particularly encouraging results. The priority to the organization is to find the fastest path to market for MOR208 in this indication.
Two studies are being 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 trial open-label Phase 2 L-MIND trial with MOR208 plus lenalidomide, we presented very promising preliminary results from the first 44 patients, 34 offering of whom were eligible for efficacy assessment of that time at ASCO. On an intensive 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 will 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 regard to breakthrough therapy designation by the FDA. Median PFS in this setting is typically substantially shorter, so we have first evidence but MOR208 could provide a real clinical benefit here.
We're now focusing all our efforts on working closing with the FDA so as to make MOR208 a new treatment options for patients who is in 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 post to presentation at this year's ASH conference in December.
We will provide an update from the sorry - the data will be based on 51 patients enrolled, 44 of whom are eligible for efficacy assessment and will be based on the same cutoff 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 for the respect of the MOR208 program.
B-MIND, the other clinical trial with MOR208 and 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 progress them to Phase three parts in June of this year. We currently expect an interim analysis of the trial in late 2018 and the primary endpoint readout in the first half of 2020.
The interim analysis is event driven and we'll be performed when 50% of the progression of debt events required for the final analysis have occurred. The purpose is two-fold. 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 trial and second, check for utility.
In addition to the two combination trials in relapsed-refractory DLBCL, we're evaluating MOR208 in the Phase 2 COSMOS trial. The trial is working at MOR208 in combination with idelalisib or venetoclax in relapsed or 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 of the presentation that one or more major medical conferences in 2018.
I'll turn now to MOR202, our investigational anti-CD38 antibody. Patient's enrollment for the study has now been completed. Everything was seemed 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 the 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 and other therapeutic fields including solid tumors in ultra-immune diseases. These results hint at wider fields of application from MOR202.
As we have said previously, we feel this program is best pursuit together with the 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've received a ruling from the second Markman hearing three 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 8263746 and 9200061. The court construed the claims at least five or two-fold better efficacy, isolated and volume Sanofi type of CD-38 that contains one or more immunoacid residues within 192 to 206 of sequence ID number 22 in accordance with our view.
We believe that daratumumab infringes three granted U.S. patents are in final process and this recent ruling on claims instruction further strengthens our view. We are seeking financial compensation on sales of daratumumab.
We turn now to MOR106. This is the investigational antibody from our Ylanthia platform directed against IL-17C, which we're co-developing with our partner Galapagos. At the end of September, we announced first results of the Phase 1 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 progression into the next clinical stage and together with our colleagues in Galapagos, we currently finalizing the design of the planned Phase 2 study.
In September, following a review of our development portfolio, we decided to terminate our collaboration with Activo Therapeutics for the development of MOR209 in prostate cancer. The program was in Phase 1 developments and the rights to the drugs developments and commercialization have been returned to Activo.
Turning to MOR103 or as it's now called GSK3196165. Our partner GSK is currently evaluating this investigational anti-GMCSF antibody in three clinical trials. The Phase 2b study and patients with rheumatoid arthritis. The Phase 2a biomarker study in rheumatoid arthritis and a Phase 2a study in patients suffering from inflammatory hand osteoarthritis. According to Clinicaltrial.gov, the trial was 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, five of which are in the clinic and one of which MOR103 is out licensed to GSK.
I'll turn now to our partner discovery segment. We believe that this segment comprising dozens of product candidates in development, who'll be at extremely lucrative royal based revenue generation from offers in the years ahead.
The approval of Guselkumab represents the tip of an iceberg that will be an enormous source of value for 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 yet give guidance regarding royalties, we can expect on this product. But overall, we see 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.
Although, the positive event came in mid-September when the CHMP Committee of the EMA recommended the approval of Guselkumab in moderate-to-serve 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 two new Phase 3 clinical studies with Guselkumab in psoriatic arthritis, thus further expanding the potential therapeutic scope of the drug.
Overall with a total of 100 programs, 23 of which are in clinical development, our Partnered Discovery pipeline continues to progress well. There is 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 on November 1, 2017. Markus has been the company's interim CSO since April 15th of this year and succeeds Dr. Marlies Sproll, who ha's been on temporary leave from her CSO position for family reasons since that date.
Marlies resigned effective October 31st due to ongoing family matters and has now taken on a new part time role in MorphoSys as Special Advisor 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're 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 Partnered 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.
Thank you, Simon. Ladies and gentlemen, also from my side a warm welcome to all of you and thanks 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 nine months of 2017.
Starting with our P&L statement on page 11, you can see that in Q3 of 2017, Group revenues amounted to EUR15 million, up 20% compared to EUR12.5 million in Q3 of 2016. The revenue increase was mainly driven by licensing milestone payments of Janssen. Thus, we emphasize that Q3 revenues do not include royalties on Tremfya sales as the first loyalty report from Janssen has not been received yet. Thus, royalties on Tremfya Guselkumab sales of Q3 2017 since launch in late July 2017 will be part of Q4 2017 results.
Total operating expenses increased by 39% to EUR38.2 million in Q3 2017. The expenses thereof for research and development amounted to EUR34.1 million, as compared to EUR22.1 million in 2016.
As planned, we have spent more on clinical development for our proprietary drug candidates than last year. Three Phase 2 studies started with our lead program MOR208 and selected blood cancer indications during 2016, one of which transitioned into a Phase 3 clinical trial in Q2 of 2017. In addition, general and administrative expenses increased to EUR4.1 million from EUR3.4 million.
As anticipated, our earnings before interest and taxes, the EBIT, came in at a minus EUR23.5 million for the third quarter of 2017 in comparison to minus EUR13.1 million in Q3 2016. Our consolidated result after taxes in the third quarter of 2017 amounted to minus EUR24 million compared to minus EUR12.8 million in Q3 of 2016. The consolidated net result per share for Q3 2017 was minus EUR0.83, after minus EUR0.49 for Q3 of 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, this segment recorded revenues of EUR0.2 million, after EUR0.1 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 EUR3 million, an increase of 68%. As a result of this cost increase, we reported an EBIT of minus EUR29.8 million after minus EUR17.7 million of 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 EUR14.8 million, after EUR12.3 million in Q3 2016. Correspondingly, the EBIT came in at plus EUR10.4 million for Q3 2017 compared to EUR7.7 million for Q3 2016.
So, now briefly, sum up the key figures for the first nine months of the year 2017, please turn to slide 13. Group revenues amounted to EUR38.6 million, 5% higher than the EUR36.7 million for the first nine months of 2016.
Again, royalties on Tremfya, sales for Q3 2017 since launch in late July when it will be part of Q4 2017. As planned, total R&D expenses rose from EUR58.8 million for the first nine months of 2016, to EUR80.5 million for the first nine months of 2017. Thereof, R&D expenses for proprietary drug development including technology development increased to EUR67.9 million for the first three quarters of 2017, after EUR46.2 million for the comparable period of the previous year.
This increase is to great extent in consequence of our intensified activities in the clinical development of our proprietary drug candidate, that are transitioning into advanced development stages. Those activities require larger clinical studies, hence the EBIT in the first nine months of 2017 came in at minus EUR53.8 million, compared to minus EUR32.3 million for the nine months of 2016.
Let's move on to the balance sheet on slide 14, as of September 30, 2017, we recorded total assets of EUR420.3 million after EUR463.6 million at year-end 2016. At the end of Q3, we had a cash position of EUR319.5 million, compared to EUR359.5 million on December 31, 2016.
As a reminder for those 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 sell financial assets, once available for sale and current and non-current financial assets classified as loans and receivables. The number of shares issued totaled 29,345,748 at the end of Q3 2017, compared to 29,159,778 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.
More of the financial year 2017, we continue to expect group revenues in the range of EUR46 million to EUR51 million. R&D expenses for proprietary drug development and technology development are confirmed to be in the corridor of EUR85 million to EUR95 million.
The guidance for earnings before interest and taxes to EBIT continues to be in the range of minus EUR75 million to minus EUR85 million. As usual, this guidance definitely includes any additional revenues from potential future collaborations and our licensing partnerships nor effect from potential in licensing of core development deals for new development candidate.
As first, royalty reporting from Janssen has not been received yet. Royalties on net sales of 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 for sales on Tremfya. As previously communicated and as reflected in our guidance for 2017, the collaboration with Novartis will conclude at the end November 2017 in accordance with contract.
Before I hand back to my colleagues, I would like to reiterate that our portfolio is growing nicely and mostly 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 progress.
The receipt of breakthrough therapy designation from 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 commerce [ph] in Q4 and the quarters beyond.
Ladies and Gentlemen, that concludes my review of the third quarter of 2017. And I will now hand back to Anke for the Q&A session. Thank you.
Thank you. We will now open the call for your questions.
Thank you. [Operator Instructions] The first question is from the line of James Gordon from JP Morgan. Please go ahead.
Hello. Thanks for taking the questions. Couple of questions on MOR208 please. One is looking at the abstract, the MOR208 looked pretty strong from the abstract splash [ph]. We also saw some good data for Roche [ph] - you had the stronger PFS, they had stronger ROI data, just which metrics do you think are more important.
Is it all about PFS, does RR [ph] matter and to what extent do you think we can compare the data, is it like to say the patients in your charts are less heavily pretreated and that could mean is it's difficult to do a direct comparison?
And just a final MOR208 question, we're just - to the breakthrough therapy designation. What is the earliest that you could potentially follow on Phase 2 data as opposed to Phase 3?
Thanks, James. Yeah, let me take those two questions. First of all, regarding the 208 data versus Roche's ADC that you pointed out.
And first of all, and this is generally a true statement. One should be extremely careful comparing data from different clinical trials. By necessity one can't match patient of course because they are completely separate trials. And so, one should be extremely cautious of comparing data between trials.
We're very, very happy and very delight about the data that we have generated. What we do know from this field is that there's not necessarily correlation between response rates and duration of survivals. In other words, between depths of response as measured by RRR or CR and duration of response as 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 with 208 has always been to provide a treatment that is effective, that is safe and well tolerated as possible and can get patient into remission and keep them there for the long-term and we feel very good about the data that we've seen so for and that 208 has the possibility to become exactly such a treatment, which is solely 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 2 study that's almost completed enrolling. That remains to be seen.
So, we're in discussion across with the FDI on exactly that point and it's too early as yet to say what the outcome of those discussions would be, but happily - the whole purpose of breakthrough therapy designation is so that the FDA can work as closely as possible when asked 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 had those discussions with the FDA and of course as soon as we have that information we'll share it with you.
Thank you. The next question comes from the line of Anastasia Karpova from Kempen. Please go ahead.
Good afternoon, and a few questions from me mostly on MOR208. In your early and preliminary discussion with FDA has dispatched that lenalidomide is not approved in DLBCL and probably will be approved in or potentially will be approved in untreated. DLBCL being a balance to any acceleration in the approval based on month [ph] study and specifically for month [ph] study do you have a possibility to change the project or to increase the recruitment and the trial size.
And more of the semantics questions, but is it true that you've made some covers in the discussion for MOR208, MOR202 partnership since your last communication of Q2 results or it's just specialist [ph]. Thanks.
Thanks, Anastasia. Let me take those, it was - your line was not so great, I think I heard them properly, but if I miss 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 have shared with the FDA, which is of course 208 plus lenalidomide.
We know that lenalidomide on its own in the setting and 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 are 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 will be interesting as what we have to do in order to get to an approval for 208. In other words, can the existing 80 patients L-MIND trial be sufficient on its own and 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 the single-arm trial of course.
These are all questions that we don't know the answers too and which are the subject to be exactly that discussion with the FDA, and as I said as soon as we have reliable feedback from those discussion, we'll certainly share it with you.
And the third question, I think regarding progress on planning 202, yes, there has been progress, but as always with these things, we don't comment on where things stand and who we are talking to and timelines 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 earn a position to talk about the outcome of those discussion and certainly to do so.
Thanks for taking my questions.
Thank you. And our next question comes from the line of Guna [ph] from Deutsche Bank. Please go ahead.
Guna [ph], Deutsche Bank. Thanks for taking my questions. 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. And so, I 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, please to see that you have made further progress and 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 get the guidance corridor, I would believe that your cash guidance would probably slightly increase any update on that front? Thank you.
Thanks, Guna [ph]. Let me start with the 208 question. We don't feel under any huge pressure to secure a part of that program at this time. And we are committed to both the B-MIND and the L-MIND trials and we are thinking very carefully and analyzing very deeply at the moment what commercialization strategy for 208 could like.
We are 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 more processes 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 have shown in the ASH abstract and we'll go into detail around at ASH, but certainly interest from potential partners, but we don't feel any particular hurry to plan the program.
Regarding 202 litigation, kind of working backwards if you remember the trial is scheduled for early 2019, and so that date got pushed back, you may remember it was regionally in the summer of next year, but the addition of the third patent to that case has pushed date of the trial back, so we now have a trial date in February 19.
And leading up to that, of course there are series of formal steps that are normal procedure for 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 that remains to be seen.
And then on the cash question Guna [ph], your expectation regarding the change in the cash position is correct. I would increase the formal guidance that we have given out of 275 to 285 by $10 million to 285 to 295 at year-end 2017.
Okay. Thank you very much.
Thank you. The next question comes from the line Igor Kim from Oddo BHS. Please go ahead.
Yes, hello. I've got a couple of questions. On 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 it during the ASH conference? And second question regarding Tremfya.
In case it will be approved in the Europe let's say in November or sometime in December. Can we expect as fast launch as with so in U.S. within two weeks after its approval? Thanks.
Thanks, Igor. Regarding 208 question, yeah, I'm sure that it will be detailed presentation of the data, which I assume will include the information you asked about that. So, there will be a complete data presentation that we get at ASH.
Regarding Tremfya in Europe, as we said we would under normal circumstance expect the decision by European Commission here in November. And with the Janssen is in a position to launch as quickly as they did in the U.S. recently, then you have to direct that question to them as to timing for potential launch in Europe.
Thank you. We currently have no questions coming through. [Operator Instructions]. Okay the next question comes from the line of Lee Cooper [ph] from Trinity Dalton. Please go ahead.
Good afternoon, everyone, and congratulations on your progress on all front. And 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 date that you've presented in the breakthrough therapy designation for 208?
Thanks, Lee [ph]. We've already had 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 satellites symposium there.
So, this program MOR208 and 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 am 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 with the event that's 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've delighted with the way it's going.
Thank you. The next question comes from the line of Thomas Hue [ph] from Equity [ph]. Please go ahead.
Thank you for taking my question. Actually, it's one concerning MOR107, so the first human study on dermatology. And could you shade a little bit light on the actual situation. And do you have any clue on the dose you might will apply in the next studies? Thank you.
Thanks, Thomas. Perhaps you're referring to MOR106 actually, the IL-17C, are ultimately T [ph] program to get with Galapagos.
Yeah. To the planning for this Phase 2 trial is ongoing at the moment, with our friends in Galapagos, and it's simply too early to say what dose we're going to go at this stage.
Do you have any concern in the competition to which dose might be held 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 in Phase 1 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 1 and the modeling data and designing the Phase 2 trial accordingly.
And commentary to the timeframe?
As I said, we're currently planning the Phase 2 trial with Galapagos right at the moment. We confirm 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 1 data, but it's a priority for both companies. So, we're looking to push it forward as quickly as possible.
Okay, fair enough. Thank you.
Thank you. [Operator Instructions] Thank you. 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 take away. There is MOR208, we'll use the momentum from the FDA's breakthrough therapy designation to focus on developing 208, plus lenalidomide and relapsed-refractory DLBCL to approval as fast as possible.
I'd like to remind you that data from the ongoing L-MIND trial would be presented at ASH, in Atlanta on December 11th, from 6 to 8 PM Eastern Standard Time, as well as in our conference call for investors and analysts one day later, December 12, at 11 AM Eastern Standard Time. Further details on that will follow.
MOR202, we're happy with progress from 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, and 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 a 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 that full year results will be 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.