Oncopeptides AB (publ) (ONCO) Earnings Call Transcript & Summary

Welcome to the Oncopeptides Q3 conference call. [Operator Instructions] Today, I'm pleased to present CEO, Marty Duvall. Please go ahead with your meeting.

Thank you and good afternoon and good morning. Marty Duvall, the Chief Executive Officer of Oncopeptides. And I'm joined today by Anders Martin-Löf, our Chief Financial Officer, to provide this operational update based on our Q3 results here at Oncopeptides. Just a reminder at the outset that on November 30, we will have a Capital Markets Day, really looking forward to that, a deeper dive into our launch planning and key opinion leader feedback on melflufen. We'll also have a post-ASH call. So we'll let you know when we get that scheduled. If we can flip to the first slide. Our Slide 2, just our disclaimer, asking that everyone please look at some of our statements online. For balance and accuracy and correctness, I will be making some forward-looking statements. So flipping to Slide 4. So as mentioned, my joining of Oncopeptides back in July was a signal of the transformation of the company into a fully integrated biopharma company. And we're really excited about the progress we've made throughout 2020, but more specifically, over the past few months that we'll provide an update on. So again, our focus in building this fully integrated biopharmaceutical company is to enhance our discovery and IND generation engine, our life cycle management of our products as they move through, focused obviously on melflufen, our lead program, at this point in time. And then the final stool -- leg of the stool here in this transformation is our launch investment and the geographic expansion of our company has undergone significant transformation with the ramp-up in the U.S. So we'll touch a little bit on the discovery and IND generation, some advances we've made to really show that we have a peptide drug conjugate platform and a second product that's moving into the clinic. Overall with the melflufen development program focused on a very large and potentially profitable multiple myeloma market currently valued at $23 billion, very broad program. We'll touch on how we intend to use our clinical studies to expand our label and be able to reach more patients. We're in the midst of this priority review at the FDA with a PDUFA date of February 28, and I'll describe for you where we're at in that process, and we're excited about the progress and where we are today. And then thinking a little bit broader about geography, U.S. launch on track. Market cap is moving in the right direction. Anders will talk to you about the cash position. And we'll talk more about our launch preparation. So moving to the next slide. We feel that we're reducing a lot of risk and generating value here at Oncopeptides and across the spectrum of this transformation. So first and foremost, with the HORIZON data, outstanding positive results in triple-class refractory multiple myeloma, derisking from a clinical perspective, our submission to the FDA and the acceptance by priority review obviously reduces our regulatory risk. Jakob moving into the Chief Scientific Officer role and me coming in with a little more global commercial -- commercialization experience really derisk things from an operational perspective. Not listed here, but we've done some expansion on the IND and drug discovery side with our investment in a new lab in Solna in Switzerland -- I'm sorry, in Sweden where we've significantly expanded our capabilities. Our OCEAN trial is fully recruited. We'll talk about that in a little greater depth. We've talked about Europe and our intent to accelerate things in Europe. So really looking forward to beginning that build. Shared up things on the financial side with the loan. And as I mentioned briefly on the prior slide, we've announced that second product, second candidate from our peptide drug conjugate platform has been submitted -- an IND application has been submitted to the FDA. So good news there. We're now a platform play. And in 2021, we'll have 2 drugs in the clinic and a lot of things going on with melflufen, obviously. So next slide, I want to focus a little bit on what's really new and our focus on the commercial build that is underway. So really paving the way for a successful launch, and we've got a tremendous team that we've recruited to Oncopeptides. You see on the right-hand side of the slide, our focus has been on bringing in people who have very significant launch experience, specifically in hematology and oncology. We also have a good blend of folks that have worked in the multiple myeloma space, understand that space, are well connected to the key opinion leaders in this area. And those important relationships will be leveraged as we look to make sure that every patient that can benefit from melflufen gets the access and the opportunity to try melflufen. More specifically on the people side, we had announced Mohamed Ladha as our General Manager of the U.S. business. I've had the opportunity to work with Mohamed at several different companies and really, really trust and believe in his experience and expertise. And he's doing an outstanding job in leading our U.S. team. Also had the opportunity to see Sarah Donovan, our Head of Marketing, in action. She brings a tremendous amount of oncology, U.S. and global marketing experience. And she built a tremendous team, has an outstanding relationship with our sales team, with our medical affairs team and has really made inroads and influences across our entire organization on the R&D side as well based on her expertise. And Dr. Paula O’Connor, we're blessed to have someone with such deep hematology experience both in academia, but also on the industry side. So 17 years of industry experience, 30 overall years of oncology experience. And she's led the development and launch of several important programs. So really pleased that she's part of our company and playing such a key role. Next slide, please. So where are we? We've talked about and discussed in the Q3 report that we're building launch readiness in the U.S. and our organization is set for launch. So what are the key things there that you should take away? We have a field sales team that's staffed and trained. As we had the PDUFA date for February 28 in our crosshairs, internally, we were working faster than that and more ambitious and look to make sure we were launch-ready in November. So we've made tremendous strides in building the team, staffing the team, training the team. So they're in-house meeting and learning more about multiple myeloma and devising ways in which we can win for patients with melflufen. Our MSL team has been onboard a little bit longer. They're now a full team engaged with key opinion leaders and also community-based oncologists and building the important relationships that will need to be successful. Market access, of course, will be important. We want to make sure that no patient is left behind as it relates to our market access activity. So we've done a tremendous amount of work, background work, working with payers to establish the relationships that are needed there. We think we're going to have a key interesting advantage, particularly in the COVID environment with our convenient 30-minute administration. And the interest -- high interest in the utilization of doublets in resistant refractory multiple myeloma in the community oncology setting in the U.S. So the oncology networks and GPOs are really an important piece of that. And we're working hard to build the relationships to make for a smooth launch. Really proud of the customer information management system that we built. We really try to make this state of the art here. We're tapping into resources, on product utilization, on the managed care side of the business to make sure that the latest and greatest real-time information is put in the hands of our field sales team, both our MSLs and our oncology account managers to understand where the activity is going in terms of ordering the product, using the product, challenges with the product so that we can be a resource to help make sure that things go smoothly. On the distribution side, our strategy set, product flow set, network established. Patient advocacy, we're doing a tremendous amount of work and relationships are strong. Medical information, a bevy of response letters and systems in place. We're going to have new data at ASH that will be incorporated into the medical information materials and responses. Our marketing materials, as you may be aware that as a Subpart H accelerated approval product, the FDA will be reviewing all of our marketing materials. We finalize them. They're just waiting for us to drop in approved label. So those will go down to the agency. We put a lot of time and effort into our patient support services. Patients are the focus for us. They're our ultimate customer. So we've built a program that looks at access, helping patients with any prior authorization support that's needed, any denials, any benefit investigation that will need to occur, looking at affordability, co-pay programs, free drug programs for the underinsured or non insured, refunding referral programs and adherence. So once a patient gets on the product, we're building in the support that is necessary for patients to make sure that they're receiving all the value they spend from melflufen. And product supply, launch quantities are built. We're awaiting the -- that label. And shipping to the U.S. So a lot of details, and we'll come back to these a little bit more in the Capital Markets Day, but exciting progress as it relates to our launch readiness in the U.S. Next slide, please. So those familiar with our program and know our clinical trials, I won't go into too much depth on each of these, just pointing out some of the key points. The HORIZON trial obviously is forming the basis for approval of the product around the globe, starting with the U.S. and then to Europe, the change in strategy there from a European perspective. We have been waiting for the OCEAN trial. And obviously, the OCEAN trial is a milestone that we really look forward to. As a reminder, this is a head-to-head comparison of melflufen versus pomalidomide in a lenalidomide refractory population. We've accrued close to 500 patients into this trial. We completed that accrual. We're in the process of tracking the events. It will take 339 events to reach a point where we'll begin to have top line results, and we'll talk about when we proceed having the results of the OCEAN trial, but very important to us. ANCHOR is really, really another important trial for us. And for those that have reviewed the program for ASH in the next couple of weeks are aware that we have an oral presentation on ANCHOR. Happy to report that the team has done an outstanding job updating the data, a new data cut. So what you will see at ASH at our oral presentation during that oral presentation will be a much more mature data, looking at the important combination data of melflufen with daratumumab and also with bortezomib. And this begins to build that foundation for moving into earlier lines of therapy and making sure that we're maximizing the value that patients can get from melflufen through combination treatment. BRIDGE study is ongoing, highlighting our unique -- what we believe is a unique benefit based on the fact that renal impaired patients, we believe, can uniquely benefit without significant dose reduction. So we're continuing that study. Importantly, it's more than just multiple myeloma as it relates to melflufen. So we have a trial in amyloidosis, and we're actively, as we think about 2021, putting in some signal-seeking trials and other hematologic malignancies that we think will be value creation points and also expand the opportunity to treat more patients outside of the diseases that we're currently focused on. Again, these value-building opportunities are obviously important to all of us. Another Phase III trial, the LIGHTHOUSE trial combination with daratumumab. We're excited to get that trial started. And then PORT, as most of you are aware, is a open-label, small study, randomized crossover, looking at the central PORT cap delivery of melflufen that we've utilized in our clinical program to date compared to peripheral infusion. So looking to provide some flexibility in the way the product is administered. So an outstanding and deep clinical development program from melflufen that we look to add to in 2021 and beyond. Next slide, please. So when we step back and thought about the target product profile for melflufen and what would make this product a potential winner in the relapsed/refractory multiple myeloma market, you see how it stacks up on the left-hand side of the slide. So as it relates to activity and that activity needing to be over 20%, we've delivered in the 2 early trials, the O-12-M1 and HORIZON, with response rates that are north of that target. Single agent approval, it's the key here in the oncology space. Even though there's a lot of combination use, it's important from a regulatory perspective as well as confidence from a clinician perspective that you prove that your agent as a single agent is an effective drug. So we do that in our single-arm HORIZON trial, but also the OCEAN trial, that pivotal head-to-head study versus pomalidomide. And pomalidomide was selected because it's a workhorse in relapsed/refractory multiple myeloma. So establishing that our activity is equivalent or potentially superior to pomalidomide is the key in making melflufen a foundational product in the future treatment of multiple myeloma and moving it up in therapy. Synergy with other drugs. We talked about the ANCHOR study, daratumumab, bortezomib. Combination in early-stage disease is important. We've demonstrated good quality of life, and we have a poster at ASH that will speak to this a little bit more related to the HORIZON trial. And I also touched on this convenient administration, this 30-minute infusion and how that's going to be helpful, particularly in the COVID-19 era where chair time is -- we're looking to minimize that, but still have patients coming into the oncology office, into the clinic, into the outpatient clinic on a regular basis to monitor how they're doing with their disease and how they're doing on therapy. So a lot of good feedback on the profile of the drug as it relates to that convenient administration. Next slide, please. So here, we link that clinical development program to opportunity. So HORIZON, our anticipated label would be in a triple-class refractory population. We have -- we call out the EMD patients, the extramedullary patients, that are at high risk. So that's a 20,000-plus patient population. EMD expands that a little bit. There is overlap as many of the patients are later stage, these high-risk patients, and have been exposed to all 3 classes of drugs. So it's a little bigger than just that triple-class refractory population. The OCEAN trial, that head-to-head superiority study versus pomalidomide puts us in a different category, a little bit earlier in terms of the course of the disease and additional 25,000 patients when we look at the U.S. market of patients that are treated with a single regimen, so not in combination. Now the ANCHOR and LIGHTHOUSE study move us to the final run here of the circles. So important that we show that combinability, that the benefit risk profile of melflufen works with some of the other key workhorse agents in multiple myeloma. And we're doing that through the ANCHOR and LIGHTHOUSE trial, and that brings the opportunity higher to more than 20,000 additional patients. So pretty exciting out of the gate and building in the future with OCEAN results targeted for the first half of 2021. We can see that working into our label in the near term as well. What does this translate into in terms of on the next slide, thinking about products, effective products in relapsed/refractory multiple myeloma? So here, we take a look at a rolling 12-month through Q3 of 2020 worldwide sales of products in the market. So clearly, a large opportunity. We see year-on-year growth across the spectrum of these products ranging from as small as 4% but up to 37% growth on an annual basis. Looking at daratumumab, there's a $3.4 billion drug in worldwide sales and growing at a pretty strong rate. At the bottom, you get a feel for first year sales of products in the category. So even at the lower end, we see sales in that $60 million to $100 million range. So exciting sales potential, exciting future potential as it relates to melflufen in relapsed/refractory multiple myeloma. Next slide, please. So I alluded a little bit to ASH, and it's an exciting way for us to end the year. Product approval would be another exciting way to end the year. But certainly, here, we know the data that's been accepted, the new data has been accepted for presentation at ASH. We think it really validates the strength of our peptide drug conjugate platform. So 12 data presentations have been accepted. The hallmark here or the key that we're most excited about is the oral presentation of the ANCHOR study. As I mentioned, that is based on a later data cut. So stay tuned for some very interesting data, updated data of melflufen in combination with daratumumab and also bortezomib. There's also some interesting posters. So we get a lot of feedback from key opinion leaders as we look at the HORIZON study, how did you do specifically in elderly patients? What about the high-risk cytogenetic patients? They're a patient that I believe could benefit from melflufen. This extra medullary cohort you mentioned is 42% of the HORIZON. How did the product do specifically in that area? If you're talking about melflufen that delivers an alkylating payload in a unique way through this peptide drug conjugate, how did the product do in clinical trials against patients who had prior alkylating therapies, 1, 2 alkylators? And we answer all of those questions at ASH in these unique posters. And by and large, the conclusion is the benefits that we see across -- the risk-benefit profile that we see across the entire HORIZON study also rings true for these unique categories. So take a look at that at ASH. And again, we'll probably have a webcast soon thereafter that we can dive a little bit deeper. And also some important signals as it relates to quality of life and quality of life analysis on patients who have been in clinical trial for melflufen. And we're also committed again to continuing to build a differentiated profile and continuing to prove that this product works different than other products. So we'll continue this investment in areas that demonstrate this differentiation of melflufen. So specifically, a multidrug resistance in certain models based on prior drug exposure or resistance, carfilzomib, bortezomib. Also some interesting preclinical work that may speak to why, from a quality of life perspective, we may be getting some good feedback as it relates to pain through this osteoclastogenesis poster that is being presented. So very exciting stuff from both clinical and preclinical perspective at ASH. And really a nice way to cap off the year as we've been monitoring and building how we're growing the awareness of melflufen from a prelaunch perspective in the U.S. and monitoring based on the evolving profile of the drug the percentage of physicians who claim that they would be very likely or likely to use melflufen in their patients. So good trends as it relates to awareness. We certainly look forward to the January time frame where we can reflect back on that large ASH presence to see how we continue to move the needle on that and also grow interest in utilization of the drug. With that, I'm going to turn it over to Anders to provide an update on the financial side related to Q3.

Thank you, Marty. If we then turn to Slide #15, you see an overview of the financial results for the January to September period for 2020. And as you can see, the operating loss increased to SEK 1, 079,900,000 for the 9-month period. That's quite an increase from SEK 495.1 million for the same period last year. If you then a look at the quarter, the loss was SEK 383.5 million, up from SEK 189.6 million compared to last year. Quarter-by-quarter, the cost is actually lower in the third quarter than in the second quarter when the loss was up to SEK 399 million. So R&D costs are down a little bit quarter-over-quarter whilst marketing and sales is continuing to increase. Going back to the 9-month figures, looking at R&D first, as you can see, the R&D costs increased from SEK 391 million to SEK 638 million. This is primarily driven by an increase in clinical and drug supply. That was SEK 470 million for this current period. The biggest contributor here is the OCEAN trial where we spent SEK 246.9 million for the 9-month period. Roughly SEK 107 million after that was drug supply. So we spent lots of money on this for the 9 period. Second on trial is the HORIZON trial where we spent SEK 49 million. Marketing and sales costs went up from SEK 71 million last year to SEK 282.9 million this year. This is, of course, driven by the buildup of the marketing [ events ] organization in the U.S. The full cost for a U.S. subsidiary was roughly SEK 249 million. Not all of that is reported in the marketing itself. SEK 61 51 million is in the admin line. A spectacular figure is the number of coworkers that increased during the period. We have grown tremendously, like 200% for the year, growing from 73 people as of September 30 last year to 232 this year. All of that -- those are now in the U.S. subsidiary. We're continuing to grow there during the fourth quarter. Cash flow for the January to September period was a negative SEK 939 million. For the quarter, it was SEK 340 million. Cash flow -- the negative cash flow will continue to increase a little bit for several years. So we're expecting somewhere around SEK 400 million in negative cash flow for the fourth quarter. So cash position was SEK 1,251,600,000 as of September 30. This was, of course, an increase as we concluded the directed share issue of SEK 1.4 billion in July. This number does not include any funding from a loan facility that we secured with the EIB in October. That's a EUR 40 million loan facility that will be available to us reaching certain milestones relating to the commercialization of that in 2021. With that, I leave the word back to Marty to go through the news for the remainder of the year.

Thank you, Anders. So we have here projecting out into 2022 some of the highlights from a news flow and major milestones. So in green, you see things that we've accomplished in the past couple of quarters. So really excited about again hitting on the milestones and providing that news flow. Two things remain here in 2020. Publication of the HORIZON data in the Journal of Clinical Oncology, we're in the final stages of that and expect that, that will be published in -- still within the calendar year. So really important for that to be part of what the sales force has in demonstrating the benefit risk profile of HORIZON. The Capital Markets Day, as mentioned, November 30. So stay tuned on that one. Look forward to that deeper dive on the clinical program and KOL feedback on melflufen, the multiple myeloma landscape we're launching into. So we think that will be a pretty exciting program. ANCHOR data at ASH. And as mentioned, we'll talk -- we'll likely have a webcast to kind of review some of the data in-depth that I hit at a very high level on the ASH slide. Looking into first quarter of next year. Again, OPD5, a sister analog to melflufen, this is a different formulation, different -- and a new chemical entity that would be focused on the stem cell transplant area. So we're really looking forward to that. The formulation enables us to deliver in a convenient way we believe higher doses of product that can positively impact these stem cell transplant patients. So early days in that program, but we're certainly looking forward to getting the first patient in, again, showing that we have a real platform in the peptide drug conjugate platform and the second product in the clinic. Results from PORT, the potential approval and launch in Q1. From an EU perspective, moving forward with our work towards gaining approval. The top line results on OCEAN. So as we track those 339 events that I mentioned, we believe that we'll have those -- we'll have reached the magical event number in time for disclosure in the first half of 2021 and would target having top line results, hopefully, at the ASCO meeting. Then we'll move to the European Hematology Meeting. ANCHOR, more data. BRIDGE study that I talked about, we'll have an update there. And then thinking even further out, it's about translating that OCEAN data into labels in the U.S. and in Europe. So exciting news flow as we move forward. And again, I think a really strong quarter, really proud of the team and how we're able to operate in what is a challenging time globally for us regarding the -- for everyone regarding the pandemic, but we continue to be focused on delivering, delivering to you, our shareholders, and delivering to the patients. So with that, I'll turn it back to the operator for the Q&A portion.

[Operator Instructions] Our first question comes from the line of Viktor Sundberg from ABG.

So three questions from me. I noticed that you expected a readout promotion, as you said, in the first half of 2021 before, but now you communicated in quarter 2 in 2021. Any reason for that? Why you did a -- why you -- can we get a more detailed time line? Are patients still going on longer than you anticipated without an event in the study? Or what's the reason? If you could give some more flavor on that.

Well, I don't think there's a real change there, just being slightly more definitive. Obviously, as you know, as the events come in, that triggers a lot of work that needs to be done on the clinical operations side in terms of data cleaning and scrubbing and verifying results, quality assurance checks. And those things typically take a few months. So as you -- as we proceed with time, we're able to hone in on that being us feeling that this would more concretely be in the second quarter. I think we had talked a little bit about, generally, the concept you're talking about, about patients perhaps staying on drug longer, which, of course, is a very positive thing from a patient perspective. No way in which we can determine how that impacts one arm versus another. But good news overall for patients, but there was no intent to signal anything any different than just the normal process here of reaching the events, cleaning the data and having it available.

Okay. And with regards to the survey you showed of around 100 doctors, it seems like a lot of doctors want to use that in triple-class refractory patients that maybe have an extramedullary disease. Did you anticipate a higher response given your data? Or should we read it as doctors aren't yet aware of your data in that subgroup. And also, did you get any comments as well on how physicians are viewing your drug? And not only yes or no answers that you could share?

Yes. No. Good question. So I would say on the EMD, it is related to the specificity of understanding and knowing that data. We don't -- we're in a situation right now where there really aren't kind of regulatory standards and key definitions and parameters that are universally agreed upon that designate whether a patient is extramedullary disease patient or not. I believe this will grow over time. I mean it's -- we're -- we don't have a final label and approval. We're not sure exactly how EMD will be handled in our final label. Certainly, if there's any type of call out, we would expect that we would be able to move the needle here. I think overall, from a feedback perspective, we get good feedback. We get feedback that this product, the profile is very interesting. The results are compelling. We know it's a crowded field. We know there are a lot of exciting things going on. We hear. Because of the time frame that we're launching in, right, and other products with similar labels in the triple-class refractory population, there's immediate thinking about the melflufen benefit risk profile relative to XPOVIO, which, I think, by and large, as you would expect, our product is seen as a product that is more tolerable, appears to be equally as efficacious. And there's a preference towards the convenient 30-minute infusion. So we get good feedback on those parameters as one thinks about some of the other choices and selinexor being one. And also with the launch of belantamab, we're early days related to belantamab. Of course, the BCMA target is one of interest and will continue to be of interest as we look at the approval and continued growth in thinking about the CAR T-type therapies. But as it relates to belantamab, a challenging product we use, particularly in a community setting with the need for the ophthalmologic kind of consult, these visual acuity, very unique adverse event profiles. So I think it's -- when it comes to the nonhematologic toxicities, which, from a melflufen perspective, there's pneumonia at fairly expected rates when we look across products. The cytopenia issue is an issue that oncologists, hematologists are used to dealing with. And there are no other large outliers on the nonhematologic toxicity profile. So it's pretty expected and a product that they think is -- will be quite manageable, that is delivering efficacy, that appears to be durable in patients of high unmet need. So early days regarding moving the line here and influencing the very likely and likely to prescribe, but we're encouraged by the numbers. And it's pretty typical, right, to see this type of flipping back to Slide 13, a stepwise fashion in terms of use in earlier patients. We know there's more work we need to do on the clinical development side to move the product up in therapy and some of the keys there being that OCEAN trial, the direct head-to-head comparison and also the combinability question. So hopefully that helps a little bit, Viktor.

Yes. And one final question here as well. So on one of your abstracts, you showed some more data on patients on previous alkylator therapy. But I kind of missed the subset of patients that were refractory to melphalan not only exposed. Will we get some more flavor on that specific group, melflufen refractory patients on ASH maybe, if you could comment on that?

Yes. Yes. I think look forward to hearing a little bit more about that, and we certainly can tease that out for the Capital Markets Day as well and post-ASH. So yes, that's an important component for us. So thanks for the questions.

The next question comes from the line of Christopher Uhde from SEB.

I just had some questions on, first of all, just sort of housekeeping. Should we expect much in the way of remaining costs from HORIZON? And then on clinical development, what -- obviously, you're going to need to do more combo trials to keep driving sales and broaden the label of melflufen once it gets approved. So other than LIGHTHOUSE, when and what -- when could we expect that you would announce new trials? And what do you need to see before you do it? And also, let's say, I guess it presumably depends a bit on what the FDA decides to do on the label now. But with respect to EMD, do you have any plans to add to the clinical data for that subpopulation specifically?

Yes. Thanks, Chris. I'll take them and if you need follow-up for any clarification, I'll certainly come back to you. So on the HORIZON, I mean the good news is there's -- we're continuing to follow some patients, but those costs are obviously coming down. I don't know, Anders, is there anything specific that we can provide at this point in time related to that?

Yes. Sure. So for this year, I think HORIZON will be sort of in SEK 60 million range for 2020. I think you should expect that to go down to roughly half that in the next year.

Okay. And then on the clinical development side, yes, we're with you in terms of more combinations needed. My understanding is the ANCHOR trial, the way it's built, we have the opportunity to open up other cohorts of patients. The focus out of the gate has been on the combinations with daratumumab and bortezomib. So that affords us the opportunity to look at some of the safety efficacy issues in a Phase II setting with those combination trials. And as you mentioned, LIGHTHOUSE is one where we're moving into a Phase III setting. We're certainly taking around internally and getting feedback from key opinion leaders on what's next, another effort in terms of combining melflufen with a backbone agent in the multiple myeloma space. As we kind of finalize and hone in on our 2020/'21 operational plan, I think as the year unfolds, you'll get a little bit more guidance on where we intend to go relating to those future studies on melflufen. We're certainly not done as it relates to relapsed/refractory multiple myeloma. And as I alluded to in some of the opening remarks, the other considerations and, of course, these are much, much lower in scope from an investment perspective would be smaller Phase II signal-seeking trials in indications that are beyond the scope of multiple myeloma. So kind of building on our platform in multiple myeloma, amyloidosis and then a couple of other heme malignancies. So I'd say stay tuned for early days in 2021 once we finalize the budget and plans and prioritization, balancing again, we -- it's exciting. When you look at the transformation of the company and you think about it from the platform and the platform delivering with multiple products, life cycle plan and a lead program that from a preclinical perspective, we have activity across a range of tumor types. And then thinking about the commercialization front and the opportunities in the U.S. and Europe, a lot of places where we can invest capital. So it's exciting. Some of those choices are tough choices. And we look forward to making them and disclosing them as we move into 2021. So yes, and your final point regarding extramedullary disease patients. So we do and do put into our kind of portfolio of trials on melflufen in the EMD trial. I think we are, in some ways, waiting to see what happens from a label perspective. But we certainly believe that more evidence in that patient population can be helpful in establishing a unique and differentiated profile for the drug. So it would be money well invested on that front should we get positive data in EMD patients.

Yes. Okay. And I mean I guess following on from the earlier combo question. I mean I guess one thing we were wondering about is whether sort of something along with like conceptually an OCEAN 2.0 were replacing not just sort of as a single agent, but replacing the combo backbone and targeted agent type of concept. So instead of continuing with VR and something else, head-to-head of VR or whatever it would be and -- versus [ Y gallo ] and some or the other newer products like or that. So that seems like a place where you might be able to show superiority with the same number of drugs again.

Yes. Interesting thoughts, Chris. Really appreciate your engagement and thinking along those lines. And I've had the opportunity over the past -- since I joined to trying to get a sense from key opinion leaders, predominantly in the U.S. and Europe and their thinking. And certainly, they mentioned some of the things that you're describing. So appreciate that thinking, and we'll certainly get back to you as the program evolves. As we commercialize it, it becomes more interesting from the standpoint of there's access to drugs in these cooperative groups that have interesting ideas, interesting studies, investigator-sponsored trials. Obviously, you would expect our medical affairs team is -- has opened up such a program globally in the U.S. with areas of interest. And certainly, combining -- and combining with new products, looking for differentiated signals would be part of our interest in looking to make melflufen even more effective for more patients. So we're certainly thinking along the same lines.

And the next question comes from the line of Boris Peaker from Cowen.

Two questions from me. First, from the regulatory perspective, I'm just curious where is the drug manufactured? And has the FDA conducted or required site inspection? And second, just thinking commercial development of melflufen, do you think XPOVIO provides a good launch trajectory that we should use as a reference?

Yes. So Anders, can you remind me on the manufacturing? It's kind of sudden. It's just not there from my slide.