MorphoSys AG (NASDAQ:MOR) Q2 2018 Earnings Conference Call - Final Transcript

Aug 02, 2018 • 08:00 am ET

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MorphoSys AG (NASDAQ:MOR) Q2 2018 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Ladies and gentlemen, welcome to the MorphoSys Half Year Results 2018 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. (Operator Instructions)

Now, I would like to turn over the conference over to Alexandra Goller. Please go ahead.

Executive
Alexandra Goller

Good afternoon, good morning and welcome to our Q2 2018 conference call and webcast. My name is Alexandra Goller, Associate Director, 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.

(Forward-Looking Cautionary Statements)

In the presentation, Simon will start by giving you an operational review of the second quarter as well as an outlook of the rest of this year. After that, Jens will review the financial results of the second quarter and the first six months of 2018. The presentation will last about 20 minutes. After the presentation, we will be available for your questions. You will find the slide deck for this presentation on our corporate website.

I would now like to hand over to Simon Moroney.

Executive
Simon Moroney

Thank you, Alex, and also from me, a warm welcome to our Q2 call. We're really thrilled with the progress that we've made as an organization in the second quarter of 2018 and the few weeks after the end of the reporting period. Our very successful NASDAQ listing was obviously a major highlight together with very encouraging progress across our therapeutic pipeline. In the next few minutes, I'll go through some of these events, focusing on individual programs and starting with our Proprietary Development segment. I'll begin with our most advanced compound, MOR208. As a brief reminder, we're currently investigating MOR208 in two types of B cell malignancies. In our L-MIND and B-MIND trials, we focus on patients with relapsed/refractory DLBCL, whereas our COSMOS trial enrolled patients with BTK inhibitor refractory or intolerant CLL and SLL.

For L-MIND, our open-label Phase II trial of MOR208 in combination with lenalidomide in patients with relapsed/refractory DLBCL, who are ineligible for high-dose chemotherapy and autologous stem cell transplantation, we are well on track. The trial is fully recruited and treatment and follow-up with patients is ongoing as planned. We will submit an abstract at this year's ASH Conference in December to present updated clinical data from all 81 patients enrolled and expect to have final data from the study available to present at an appropriate medical conference in the middle of next year. Armed with breakthrough therapy designation for MOR208, plus lenalidomide, we are in ongoing discussions with the FDA regarding a potential filing based on the L-MIND study. If everything goes well with our preparations and our alignment with the FDA and, of course, if the data are positive, we expect to be able to start with our rolling submission in the second half of 2019, which would allow for a potential approval in the first half of 2020.

B-MIND is our Phase