MorphoSys AG (NASDAQ:MOR) Q4 2022 Earnings Call Transcript

MorphoSys AG (NASDAQ:MOR) Q4 2022 Earnings Call Transcript March 16, 2023

Julia Neugebauer: Ladies and gentlemen, good afternoon and good morning. My name is Julia Neugebauer, Head of Investor Relations at MorphoSys, and it’s my pleasure to welcome you to our Fourth Quarter and Full Year 2022 Financial Results Conference Call. Joining me on the call today are Jean-Paul Kress, Chief Executive Officer; Sung Lee, Chief Financial Officer; Tim Demuth, Chief Research and Development Officer; and Joe Horvat, US General Manager who will join for the Q&A. Before we begin, I’d like to remind you on slide two that some of our statements made during the call today are forward-looking statements, including statements regarding our expectations for the commercialization of our products and our development plans and expectations for the compounds in our pipeline as well as the development plans of our collaboration partners.

These forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in MorphoSys’ 20-F and annual report, all for the year ended December 31, 2022, and from time to time in other SEC documents of MorphoSys. It is important to keep in mind that our statements in this webcast speak as of today. On slide three, you’ll find the agenda for today’s call. Jean-Paul will begin with an overview and will give an outlook. Then Tim will provide an update on our development pipeline, before turning the call to Sung for a summary of our fourth quarter and full year 2022 financial results. Following these prepared remarks, we will open the call for your questions.

With that, I now hand the call over to Jean-Paul.

Jean-Paul Kress: Thank you Julia. Good morning and good afternoon, everyone. Thanks for joining us today. 2022 was another transformative year for MorphoSys. We are determined to have two medicines available to cancer patients by 2025, and we are confident that we will accomplish this. This confidence is reinforced by our clear strategy, highly qualified team, financial strength, and most importantly, the best-in-class mid to late stage pipeline. Pelabresib, our investigational best inhibitor, represents our largest and most immediate opportunity. This investigational medicine has great potential to improve the standard-of-care in myelofibrosis. Today myelofibrosis treatments revolve around the use of JAK inhibitors. These medications focus on relieving symptoms of myelofibrosis rather than treating its goals.

But with this treatment strategy, only about 50% of patients achieve adequate symptom control and for many that relief fades with time. People suffering from myelofibrosis are in critical need of treatment options that not only address their symptoms, but also act to change the overall course of their disease. Phase 2 results from our MANIFEST study suggest that pelabresib in combination with a JAK inhibitor may offer prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks. In speaking with physicians who treat myelofibrosis patients, we hear that depth and durability of responses are limited with current first-line therapy. During these conversations, physicians reiterate the excitement about the latest pelabresib data and the therapies potential in helping address their patient’s needs.

We continue to prioritize the Phase 3 MANIFEST-2 study of pelabresib in myelofibrosis. We look forward to sharing top line data from this trial in early 2024 in less than a year from now. Beyond myelofibrosis, we also see potential with pelabresib in treating other myelo diseases. We continue to educate the medical community on the efficacy and safety profile of Monjuvi in combination with lenalidomide as a treatment for patients with relapsed of refractory diffuse large B-cell lymphoma, also known as DLBCL. When speaking with treating physicians, we focus our efforts at increasing median time on therapy to achieve the most durable results in the eligible patients. Monjuvi addresses an important need for patients as the only outpatient in office immunotherapy in so compliant DLBCL.

We are on track with the number of prescriptions we have seen thus far in 2023. In the future, we also see these established relationships helping us educate physicians on the benefits of pelabresib if it’s approved by regulatory authorities, as many of these doctors treat patients with both conditions. We believe the largest opportunity for Monjuvi is yet to come. Beyond the currently approved indication, we are exploring Monjuvi use in two pivotal studies for patients with first-line DLBCL and for patients with in the lung lymphomas. The frontMIND study in first-line DLBCL is progressing very well and we look forward to sharing data from the trial in the second half of 2025. Over the past 12 months, we also took steps to optimize our cost structure and to further strengthen our financial position.

This included, for example, the adjustment of our selling expenses are most recently the decision to stop work and operations on our preclinical research programs. We continue to concentrate our investments on our most advanced clinical programs that will create near term value. As part of this focused strategy, last year we also outlicensed product candidates that are outside our focus in oncology or are in early stage development. This included a licensing agreement with Novartis for preclinical inhibitors of a new cancer target and with HI-Bio for felzartamab and MOR210. And other terms of these agreements, we received competitive upfront payments and we will be eligible to receive certain milestone payments and royalties. Also, three of our partner programs, ianalumab, abelacimab and setrusumab are now in late page clinical development.

At the end of last year, we announced that Sung Lee, our Chief Financial Officer, will leave MorphoSys at the end of this week. I would like to thank Sung for his contributions and I wish him the best for his future. I am very pleased that Lucinda Crabtree will join MorphoSys as our Chief Financial Officer. She will start in the third quarter of 2023 at the latest. Lucinda joins us from Autolus. She’s a seasoned executive with broad biotech experience in corporate roles and as an investment professional, both on the buyside and the sellside. I would now like to turn the call over to Tim to provide a development update. Tim, over to you.

Tim Demuth: Thank you, Jean-Paul. In 2022, we advanced our ongoing clinical programs and made great strides. Let’s start with pelabresib. As Jean-Paul mentioned, the Phase 3 MANIFEST-2 through study of pelabresib in combination with ruxolitinib in patients with myelofibrosis is our key priority. The trial is progressing well and we expect to report top line data in early 2024. The primary endpoint of the study is a proportion of patients who achieve a 35% or greater reduction in spleen volume at week 24, known as SVR35. Reduction in spleen size is used as a clinical endpoint in myelofibrosis because spleen enlargement causes significant pain and is associated with disease activity. The key secondary endpoint of this study is a proportion of patients achieving a 50% or greater improvement in total symptom score as measured by the myelofibrosis symptom assessment form, or MFSAF, from baseline at week 24.

Patients with myelofibrosis experience a severely diminished quality of life due to symptoms such as fatigue, fever, and weight loss. The MFSAF is a validated tool specifically for myelofibrosis patients that can track changes in these symptoms. Please recall that when we took over the program from Constellation, we optimized the study by increasing the number of patients to approximately 400, and we feel very confident with the improved trial design. The MANIFEST-2 study is supported by findings from the Phase 2 MANIFEST trial of pelabresib in combination with ruxolitinib in patients with myelofibrosis, including those who were JAK inhibitor naive. Updated results from MANIFEST were presented at the ASH annual meeting in December, 2022. These results suggest that pelabresib in combination with ruxolitinib provides prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks.

We also presented preliminary research indicating the association of biomarkers with disease modifying activity of pelabresib. The results from the MANIFEST study were also recently published in the Journal of Clinical Oncology. Based on the body of data we have presented thus far, our confidence in pelabresib and the Phase 3 MANIFEST-2 study is high. Moving on to tafasitamab. This medicine continues to address an important need for patients with relapsed or refractory DLBCL. At the 2023 AACR annual meeting final data from our pivotal L-MIND study will be presented during an oral presentation spot lining five-year efficacy and safety results in these patients. The results which build on the data presented at SOHO last year further support the curative treatment potential of the tafasitamab and lenalidomide combination for patients with DLBCL, as these patients are experiencing durable remissions and long-term responses with treatment.

Beyond the currently approved indication, we’re exploring tafasitamab in two Phase 3 studies, frontMIND and first-line DLBCL and inMIND in relapsed or refractory follicular or marginal zone lymphoma, which is being driven by our partner Incyte. For about 50% of patients with high intermediate and high risk DLBCL, the standard-of-care first-line therapy R-CHOP is ineffective, and the prognosis for patients with relapsed or refractory disease is very poor. We are investigating the potential of adding tafasitamab and lenalidomide to R-CHOP to increase the DLBCL cure rate in the first-line and help more patients avoid relapse. At the 2022 ASH Annual Meeting, we presented final safety and efficacy results from our Phase 1b trial firstMIND, the precursor study to frontMIND.

These results underscore the therapeutic potential of tafasitamab in combination with lenalidomide added onto standard R-CHOP therapy for patients with first-line DLBCL. Finally, let’s turn our attention to tulmimetostat, our mid-stage investigational next generation EZH2 inhibitor. Abnormal EZH2 function is implicated in several ways in cancer and may make tumors more resistant to anti-cancer treatment. Tulmimetostat is designed to improve on first generation EZH2 inhibitors to increase potency, longer resonance time on target, and a longer half-life. Our excitement about this mid-stage program increased in 2022 with the release of early proof-of-concept data. Initial data from our Phase 1/2 Basket study showed encouraging monotherapy responses in heavily pretreated patients with ovarian and endometrial cancers, as well as mesothelioma and peripheral T-cell lymphoma.

These preliminary results are promising, and we look forward to learning more as the trial progresses. We have a strong mid to late stage pipeline. We look forward to sharing pivotal data over the next few years with the MANIFEST-2 trial results expected in less than 12 months. With that, and now turn the call over to Sung to review the financials.

Sung Lee: Thank you, Tim. We’re pleased to share our financial results for the fourth quarter and full year of 2022. Moving to slide 17. Monjuvi sales were $25.3 million in the fourth quarter of 2022, reflecting a 7% year-over-year growth driven by demand. Sales in the fourth quarter benefited approximately $1.2 million from seasonal inventory dynamics. For the full year, Monjuvi sales were $89.4 million, delivering 13% year-over-year growth. In the fourth quarter of 2022, we recorded oh €0.7 million in royalty revenue for Minjuvi sales outside of the US from our partner Incyte and recognize €3 million for the full year. As our partner Incyte has recently seated, the Minjuvi launch is ongoing in four key markets with the majority of sales thus far coming from Germany.

Total revenues in 2022 were €278.3 million compared to €179.6 million in 2021. This increase resulted mainly from higher revenues from licenses driven by the out licensing agreements with HI-Bio and Novartis. Total cost of sales was €48.6 million in 2022 compared to €32.2 million in 2021. Cost of sales specific to Monjuvi US product sales was €22.6 million in 2022 compared to €12.3 million in 2021. The year-over-year increase was driven by higher sales of Monjuvi and a €5.1 million charge related to activities to optimize the Monjuvi supply chain. Turning to operating expenses. R&D expenses in 2022 were €297.8 million compared to €225.2 million in 2021. The growth was driven primarily by the advancement of our clinical programs and the full year impact of the Constellation acquisition.

Selling expenses decreased to €92.4 million in 2022 compared to €121.5 million in 2021. Recall that we made additional investments in 2021 to support the first full year of the Monjuvi launch. We will continue to carefully monitor our Monjuvi co-commercialization investment to ensure that it is commensurate with revenue expectations. G&A expenses in 2022 were €60.1 million compared to €78.3 million in 2021. The year-over-year decrease is primarily due to the transaction costs for the Constellation and Royalty Pharma agreements completed in the third quarter of 2021. For the full year of 2022, we reported a consolidated net loss of €151.1 million compared to a net loss of €514.5 million for the same period a year ago. The lower consolidated net loss in 2022 was driven mainly by the recognition of finance income triggered by the reduction in financial liabilities from collaborations.

Turning to our balance sheet. We ended 2022 with cash and investments of €907 million compared to €977 million at the end of 2021. Our solid cash position enables us to not only reach the pivotal data milestone for the Phase 3 study of pelabresib, which has anticipated in early 2024, but to also provide a cash runway of at least 12 months before the pivotal data readout. Turning to our guidance for 2023 on slide 19. We are reiterating our guidance that was provided at the beginning of January this year. All aspects of our guidance remain the same. Specifically to Monjuvi US net product sales and the expected pace this year, we expect to see the first quarter of 2023 sequentially lower due to seasonal dynamics and remain on track to deliver within our full year guidance range.

Before I hand the call back to Jean-Paul, I would like to conclude by thanking you, the investment community, I have truly enjoyed our interactions over the past two years. Back to you Jean-Paul.

Jean-Paul Kress: Before we go into Q&A, I would like to conclude with a few words. We remain focused on driving our mid to late stage pipeline forward. With pelabresib, we have a tremendous opportunity to improve the standard-of-care for patients with first-line myelofibrosis, and we expect the top line data from our Phase 3 study in less than a year from now. We are well financed to advance our clinical programs, and we will continue to focus on our resources, on our strategic priorities. And with that, I’d like to open the call for questions. Operator, please open the line.

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Q&A Session

Operator: Ladies and gentlemen, at this time we will begin the question-and-answer session. The first question comes from James Quigley from Morgan Stanley. Please go ahead.

James Quigley: Great. Thank you for taking my questions. I’ve got two please. So, first of all on the POLARIS Adcom. So, Tim, I’ve been interested in your views here, particularly around the relative importance of the endpoints. And also, again, maybe it’s before your time, but in terms of your discussions with the FDA, did they give you any indication of what they think would be a clinically meaningful absolute PFS benefit? And also their thoughts on the importance of the OS trend? And then secondly with — again, related to POLARIS, and the Adcom. What was your thoughts on the fact that most of the OS benefit or the OS was driven by the high grades DLBCL patients? And is that something you’ve seen in earlier studies? Then — and the quick one on firstMIND as well.

When can we expect the next cut of the data? You said in the slide that 94% of patients are alive after 24 months. Have you done any work to track what this looks like versus historical or — and the in POLARIS? And then also on firstMIND, can you give us an idea of what the CR rates was as it wasn’t split out in the slides or in the ASH presentation? Thanks.

Tim Demuth: Thank you, James. So, let me try to summarize the questions you asked. First of all, you wanted to hear importance of the endpoint FDA expectations on the PFS benefits, importance of OS trends and the contribution of high grades, and then, some more details on the firstMIND results. So, let me try to start with the importance of the endpoint. So, first of all, I think the ODAC was a very positive ODAC for first on DLBCL patients. It’s clearly has a positive read through on our frontMIND trial. The panel very clearly endorsed PFS as an accepted endpoint without the need to wait for many, many years to show an oval survival benefit that I think is a very important message for us and gives us an even greater confidence being able to get frontMIND to approval and to patients.

I guess that also answers your question around the relative importance of that OS trend. It was clear from the advisors that OS could not be shown in a reasonable period of time. At the same time, of course, you want to see a positive trend in OS. And if I go back to the data we’ve presented from our firstMIND, there was the poster at ASH last year. It very nicely shows and gives us a lot of confidence. Hitting the relevant end point here. If I can just quote the overall response rates that you were asking for, we’re talking about response rates of close to 94%, 93.9%, to be correct in the overall population, which I think tracks very nicely against what’s the pertuzumab trial showed as well. Again, additional confidence. I’m looking at our 24-month PFS rate, which is right up there with pertuzumab.

So, I think taking all this together, we have great confidence in being able to have a positive readout from the frontMIND study.

James Quigley: Great. Thank you.

Operator: The next question comes from James Gordon from J.P. Morgan. Please go ahead.

James Gordon: Hello. James Gordon, J.P. Morgan. Thanks for taking two questions. One question was just on Pela. So, hematology being a pretty popular area with lots of companies. Is it possible we see anything ahead of you actually announcing the data early next year in terms of partnerships or sort of involvement with other companies? Or is it really just wait for the data now? Could there be anything else that happens ahead of it? And then the other question was on Monjuvi. So, the Symphony data, when I look at it for February is showing a sequential decline. And is your competitive intelligence saying that’s just seasonality, or is that the step up in competition that I think you’re expecting to see as well? So, do you think we are going to then see a sequential growth in Q2 and Q3 as we move through the year?