Earnings Call: Q4 2020

Feb 18, 2021

Okay. Thank you. So good afternoon and good morning to all. Really excited to provide this operational update on oncopeptides, our Q4 report and reflecting back on an outstanding year that was 2020. And obviously really excited about the year that lies ahead. So as a reminder, I'll be making some forward looking statements. So please refer to some of our disclosures and filings for appropriate fair balance. And currently on Slide 3, So I'm joined today by our Chief Medical Officer, Doctor. Klasbacher and also our Chief Financial Officer, Anders unlock. So we'll handle various sections of this particular update. So moving forward to Slide 4. Update. So as mentioned, 2020 has been a transformational year for Oncopeptides and we've been able to work into a fully integrated biopharmaceutical company and had the opportunity in 2020 to beef up these 3 major sections of our company, discovery and IND generation, our portfolio and life cycle development of melflupin, our lead product, and also looking forward to the commercialization side, a significant investment and now we are prepared for our first commercial launch. So our hope is this is the last quarterly update without revenues, which would be truly exciting for all of us, obviously. So on the discovery IND generation side, as you know, we're looking at targeted therapies for hematologic diseases. And besides our product Melflupin, we have a second product in the clinic now, OPD5 and look forward to bringing new chemical entities from our peptide drug conjugate platform. So very excited about the prospects for that and we'll be guiding more specifically on developments there. We expanded our operation in Stockholm and have really beefed up our efforts in this discovery in IND generation area. In the middle, as it relates to melflupin, focus on the relapsed refractory multiple myeloma market, a huge global market. We recognize it growing to the range of $23,000,000,000 in the next couple of years. We have a very broad program. We're currently in priority review. And as you know, we have the PDUFA date that is just one and a half weeks away. So very excited about that and Doctor. Bacher will get into some of the details here with respect to the lifecycle plan. And then on the commercialization side, as you know who follow our story closely, we are ramping up for the U. S. Launch. We currently sit with a market cap of around $1,400,000,000 and our cash position at the end of Q4 is roughly 100,000,000 So really excited about moving forward. So on Slide 5, we touch on Q4 and the highlights of Q4. And we did a lot of work regarding our commercial readiness, again, prepared for this FDA user fee date February 28, which happens to be on a Sunday. So stay tuned for that news. We're poised for either Friday day or earlier, don't know the exact date. So we're pretty much to the finish line. It's an all or none proposition, but we're feeling good about where we are today. Really also pleased that in the Q4, the full data set for the Horizon study was published in the Journal of Clinical Oncology. This is really an important aspect in launching a brand to have the black and white clinical data in its full glory that will be available for our team to provide to healthcare professionals in the U. S. And around the world for that matter. So that full data set being published in the Q4 was really a highlight. At the ASH meeting, we saw the update on the ANCHOR trial and some of those details that really paved the way for the Phase 3 trial lighthouse. And that trial has been opened and in the Q4 we had the 1st patient enrolled. This is a combination with daratumumab, which is a really exciting drug, really fast growing drug and the synergistic combination of melflupin and daratumumab is quite encouraging, particularly when we look at the results of the ANCHOR arm relative to other products that have combined with daratumumab. As I mentioned with OPD5, the FDA accepted our IND application. So second drug in the clinic. So we're really playing out this peptide drug conjugate platform and are excited about a portfolio of products that could be in our future at Oncopeptides. We've also made nice progress in Europe and have discussed that a little bit. So we've switched our focus and strategy from an ocean based filing to utilizing the Verizon data. So that Verizon data was so significant and really pleased to see the FDA's obvious acceptance of that to also potentially utilize it with the EMA for an earlier launch than anticipated in Europe. So stay tuned. We'll continue to make progress and continue to guide on that front. And finally, from a financial perspective, we announced a $40,000,000 loan agreement with the European Investment Bank that really provides us some flexibility from a financing perspective as we move forward. Moving ahead to Slide 6, our commercial launch strategy and geographic expansion. And really we're focused on driving and maximizing shareholder value here. So obviously, U. S, go at it alone, launch ready PDUFA date. I'm calling from our Boston based headquarters. We've got a commercial presence. I'll go into that here in a little more detail established across the United States ready to launch melflupin into the marketplace. As it relates to Europe, we're in that regulatory phase. We have made the early indication and strategic declaration that we intend to go at it alone, having grown from European roots in Scandinavia and Stockholm. We have the talent and we believe the know how to also go at it alone from a European point of view. You'll see some work to that end upcoming as we are recruiting leadership and expanding our talent and capabilities to commercialize drug in Europe. RAPTOR and CO RAPTOR were assigned in Q4 and we look forward to continued discussions there and providing updates as we move forward. As it relates to Japan and other Asian opportunities, likely a partnering strategy as most biotech companies of our size would be thinking that way. We're looking at the current gaps, what we need to do from a clinical development perspective to have a full package for PMDA and for continued progress in Japan. We're engaging with KOLs and making sure our data is known in the Asian geography as well. So that's kind of our thinking from a geographic perspective. Moving forward to Slide 7, We are paving the way for a successful launch and ready for that successful launch. Our organization has grown very significantly. We put the emphasis on a couple of different factors. 1, we want experienced oncology, hematology professionals, and We have done that. And secondly, we've made sure that we've also built into the team a lot of multiple myeloma expertise. So really pleased with the mix of folks that we have available. You see some of our leaders here and their backgrounds outlined. And at the bottom of the slide, you see that we've attracted talent from the who's who related to the oncology hematology space in the United States and globally. So really excited about the team and moving things forward. So on Slide 8, just being now 2 weeks from the PDUFA date, just to provide a checklist here, field based hiring done both on the commercial and medical side, training, account profiling. Update. So a lot of details regarding who we're calling on, the priority of this calling, the call list, promotional materials, submitting these materials in advance to the FDA. We'll be under the subpart H as an accelerated approval drug. So these materials need to go in with our filing, state licensures. We've really put the emphasis on patients and we put patients first at oncopeptides. So related to co pay and really white glove service as it relates to taking care of patients, communication with patients, making sure that they're getting the best possible experience that they can get in utilizing moflufen as part of their disease and multiple myeloma treatment. Distribution strategy in place, GPO agreements in place, excited about some of the connections we have there and what we're going to be able to do in the marketplace. Speakers KOL engagement, supply chain preparedness and really built a state of the art system that is going to help our internal team communicate, understand dynamics, changes in the system when there's a prescription, there's alerts at the field level and we're able to support whether it be through our oncology nursing team for our oncology account managers or medical science liaisons. People are aware and we're there to support to healthcare professionals that are helping to support the patients. So moving forward to Slide 9, connecting again the clinical development program, our excitement there with the relapsed refractory multiple myeloma market. And first of all, we have the horizon trial. Think about the fact that the horizon trial when it was kicked off, we did not anticipate that this trial would rise the level of leading to an early approval of the drug in the United States or Europe. So outstanding data focus on triple class 3 patients. This is obviously an area of high unmet need. We've kind of characterized this market in the U. S. As being roughly 20,000 patients. Really key milestone for us in the first half of this year besides the launch is the OCEAN trial. So the head to head comparison with pomalidomide moves us up in line of therapy. So this more than doubled the number of patients that may be available to us from a labeling perspective. But also keep in mind what we put at the top of the slide here, as we move up in therapy, not only do we expand the patient number, but also the expectations in terms of the duration of therapy on melflutin and the length of time in which a patient can benefit from the drug on average also increases significantly. So this speaks to a growing revenue opportunity as we continue to play out this clinical development plan. So on the Lighthouse trial, the green box is the combination with either PI proteasome inhibitor or anti CD38. Obviously, Lighthouse is focused on daratumumab, again, an increased patient population and longer duration therapy based on the outstanding data from ANCHOR that Doctor. Bachter will speak to. So with that, I will turn the program over on Slide 10 to our Chief Medical Officer, Doctor. Klosbacher. So thanks Klos. Thanks, Marty, and good afternoon, good morning, everybody. If we go to Slide 11, please. So on Slide 11, we see the clinical development program of Melifen. And some of you may have seen this slide before. Update. I will touch briefly on it, after which I will go into some details of the specific trials. So these are the studies that are currently ongoing. The 12M1 study on the far left was the dose finding study. Horizon, obviously, our pivotal study for which we anticipate an approval soon. The OSHU study fully enrolled and slated for a readout in the first half of this year. ANCHOR, our very important combination trial where we combine melflufen with various backbone drug in multiple myeloma. And then we have BRIDGE and PORT studies where we respectively look at patients with renal impairment and we look at possibility and feasibility of peripheral infusion of Nafluk and with port. And both bridge and port Lighthouse trial started in Q4 last year and very important for us moving forward as we aim to move upswords in the treatment trajectory. We have started to also study naflutide in other indications. And the first one where you have a trial ongoing is the ASCEND trial, and that is a trial in light chain amyloidosis. And we hope to provide you with some first results there by the end of this year. If we go to Slide 12, please. And this is quite an exciting slide from our perspective because update. What you've seen before on Slide 11 was the known clinical development plan, but we are planning to expand update on the next slide, both in multiple myeloma, but also in new indications. So if we first focus on myeloma, we will have a study specifically in patients with tranabulary disease. And as you may know, this is the most difficult to treat patient population in multiple myeloma. Update. And here we will look at a combination study with bortezomib, nalfluffin, dexamethasone in soft tissue extramedullary disease and especially the soft tissue extramedullary disease is known to be very difficult to treat. But we were very encouraged by the data in extramedullary disease in Horizon. So this made us very excited about the opportunity to now have a study fully focused on extramedullary disease, and we expect to have the first patient in there in the second half of 2021. Moving forward, we are looking actively at a combination study with an anti BCMA agent, either a BiTE compound or CAR T, and this will hopefully enable label expansion in the future in combination treatment. And this will be a very important study moving forward where we anticipate a first patient in around year end this year. That's for myeloma on the short term, but we're also expanding in new indications. And important to note is that this is all based on highly encouraging preclinical data in these other indications. Update. As our company is focused on difficult to treat hematological diseases, we and the very encouraging data from a preclinical perspective. We have decided to move forward in acute mildly leukemia, a disastrous disease. Patient after 1 year have an overall survival of less than a year, sorry, after the first treatment. And here we will start a Phase I study in relapsed patients, and we expect the first patient in also around year end this year. And then based on the positive results that we have seen in non Hodgkin lymphoma, we have decided to move forward with a Phase III study in relapsed diffuse large B cell lymphoma. We are also an area of high unmet medical need, limited survival in relapsed patients, especially the relapsed high risk patients. And here, we expect the first patients in the second half of 2021. So a lot of ongoing activity in the near future, all focused on first broadening our footprint in multiple myeloma, but also now focusing on other indications of high unmet medical need. If we go to Slide 13, please. This is where we have a snapshot about what we presented at ASH in December last year. And just very briefly, I think it's important to note that If we look at competitors like GSK, like Karyopharm, we actually had more presentation at ASH than these main competitors from us with 8 clinical presentations, 4 preclinical presentations and notably one oral presentation based on the daratumumab arm of ANCHOR. Update. And if we speak more about ANCHOR and if we go to Slide 14, please. So ANCHOR, as mentioned, is a BOSCET study. This is a Phase III study where we look at the combinability of nalflucan with either vortezanib, Velcade or with daratumumab DARZALEX. And these are patients who have undergone 1 to 4 previous line of therapy and they should be refractory to either an image or a PI or both. So please note that all of these patients are refractory. We look at PFS from an efficacy perspective. And of course, we also look at early signal in overall survival. And if we take a look at the results in the daratumumab arm on Slide 15, please, we see on the left hand, we see the so called swimmer lane of the patients. So this is really all the individual patients depicted and their ongoing responses. Currently, we see an overall response rate of 73%, which is very encouraging, and I will speak to that later when we make a comparison, the competition. But very importantly, a median PFS of almost 13 months, 12.9 months to be exact, and we still have patients ongoing. Overall survival, immature, but still 18.4 months at the time of the data cut. All in all, very encouraging data. I'm very pleased with that and this laid the foundation for our Lighthouse trial on which I will speak shortly. Update. If we go to Slide 16, please. This is the responses in the bortezomib trial. We have now completed the Phase I part of the study with a 62% overall response rate. Also encouraging, most importantly, no new safety signals with both combination both with daratumumab and bortezomib. We have, from a safety perspective, the so called go ahead opportunity to further expand our clinical footprint. And at this stage, the bortezinib combination is too early to have a median progression free survival that we are currently enrolling the Phase 2 part of the study. Update. Now what does that mean? And if we go to Slide 17, please. So Slide 17 shows from the left to the right, the refractory status of the patient. So as you may be aware of, a patient can be relapsed or refractory, But there is always a kind of level of refractory net. Is it all patients? Is it 60%, 80%? And that is very important if you look at what does good look like because the earlier the patient, so the less refractory the patient, Actually, you expect better results. And if we then position Anchor, and that's above the blue arrow. And we compare that to the major trials of combinations with both bortezomib and daratumumab. We actually matched them to the refractory status that we have actually enrolled in this postulation. And if you then look at the daratumumab arm, 30 months holds really well up with Eloquent 3, but also with the recently presented APOLLO data. And then for ANCHOR, later patient population, full refractory 62 percent ORR. So we feel very confident with these results from ANCHOR that we will be able to compete in this space as well. Next slide, please. So Lighthouse, as mentioned, based on the previous mentioned results on ANCHOR study of NALFluft and plus there are 2 in lab versus deratumumab randomized 1 to 1. Importantly, the subcutaneous version of deratumumab and this is really to expand our market potential, where we really hope to show an efficacious and safe observation. And the study is ongoing. Primary endpoint is PFS with secondary endpoints, OS. Opportunity and the study is at this moment recruiting patients. Then to Slide 19, please, where I will briefly touch on the OCEAN study. We are very easily anticipating the results. We still expect that to be in the first half of this year. As said, fully enrolled trial, 4 95 patients, naflutin dex versus thromalidomide dex, head to head, quite unique in this setting, not the typical triplets versus doublet with primary endpoint of PFS and secondary endpoint of overall survival. And this study basically is reaching its primary endpoint when we are either non inferior or superior. And I'll talk about that a little bit in the next slide. So if we go to Slide 20, please. So this is a graphical depiction of what a non inferiority and a superiority result mean. Update. So if we focus on the graph on the left lower side first, this is actually a slide where from left to right, the handset ratio is depicted with 1.0 in the middle. And if you actually are at 1.0, that means that both drugs are performing identical in the study. To the left, with hazard ratios below 1.0, that means that naltlutphen does better opportunity to the right from a little mitralized data. A superiority result would mean a hazard ratio below 0.8, and that is the dark green example. But importantly, a non inferiority result would still mean a hazard ratio between 0.81.0. So in both the non inferiority and the superiority design nafluthan will beat thromalidomide in the study, albeit with different levels of significance. So comedodumai casano is widely used in par and we feel that both the non inferiority result and the superiority result will significantly expand market opportunity. From a regulatory perspective, if we look at the superiority result that will lead to full approval in the U. S. As well as in the EU. If we look at non inferiority, while it is sufficient in the EU for the FDA. That means that we will have to look at the totality of the data, which means that we look at the combined efficacy and safety results. And this is then basically a negotiation with the agency, outlook, something we feel very confident about should we reach that non inferior OEQ result as well. Update. So with that event being the next big event from a clinical perspective, I would like to hand over now to Anders Martin Lutz, our CFO. Andres, over to you. Thanks, Iclos. If we turn to Slide 22, you see the figures for the year. Update. First of all, you can see that operating loss increased from roughly SEK 739,000,000 in 2019 to SEK 1,600,000,000 in 2020. We saw the same trend during the last quarter of the year where we went from $204,000,000 in Q4 2019 to $511,000,000 in Q4 2020. I would say that the Q4 2020 costs were exceptionally high due to some accruals of R and D costs in the quarter. So So that was quite a steep increase from the Q3, but we will not create sort of a similar increase going forward. If you look on the left hand side, you see in the graph that R and D costs went from SEK548,000,000 to SEK 866,000,000 That's primarily then driven by the increase in clinical studies costs and drug supply. That was SEK 600,000,000 roughly after the SEK 866,000,000 and also the 600, OCEAN, the OCEAN trial for sero costs and clinical supply pickup for roughly half of SEK 340,000,000. So it's a massive project for us that is now getting close to completion. The marketing sales cost went from $127,000,000 to $456,000,000 That's, of course, driven of the buildup of our commercial and medical affairs infrastructure in the U. S. That was roughly 3 quarters of the cost, so 329 out of the 456 was U. S.-based organization. And all of this increase is, of course, driven by a massive increase of the company, both in marketing and sales, but also in R and D and I've been hearing in Europe. We went from ACH to 280 in 1 year, which is just astonishing to me. It will not be repeated next year. We will see some increases in marketing and sales that will continue. But looking forward to next year, I would say that R and D costs are going to be roughly in line with the 2020 costs in 2021. So will G and A that will also be I think we have a modest increase there, whereas the marketing and sales cost will continue to increase. It was 4.56 in 2020. I think the cost was SEK 173,000,000 in the 4th quarter. That's the best approach for where we're going. But I think that will increase slightly over the coming quarters. So that should give you a view on basically where we end up for 2021. Update. Turning then to cash flow. We spent roughly SEK1.3 billion in 2020. For the Q4, the cash flow from operating activities was SEK357,000,000. So that was an increase from the 3rd quarter. We were also hit by a negative exchange rate effect of SEK 53,000,000. So the current the total net cash decrease was SEK 411,000,000 for quarter. And that left us with a cash position of SEK 840,000,000 as of December 31. You see where we have raised money And we also have then a €40,000,000 loan facility that we secured in October. So all in all, we have Before that we have roughly cash to go through the Q2 of the year, excluding the loan facility, and we sort of reiterate that guidance at this point. I think that was all for me. And then I'll leave the word back to Martin to summarize. Thanks Anders. And moving then to Slide 24, you see the focus update of the call here has been on the accomplishments in Q4. And then of course, the emphasis here on Q1 potential accelerated approval in the U. S. And the commercial launch. So excited about those milestones. And then, of course, in the first half of twenty twenty one and more specifically in Q2, top line Ocean results. So still tracking towards, as we know, this is an event driven trial. We believe we're in a place where that guidance continues to work. So please look forward to the Phase 3 results, top line results being communicated on the OCEAN trial in the first half of twenty twenty one. Update. We'll also continue of course with our 2nd Phase 3 trial and look forward to very significant increases in our accrual to that trial and guiding towards getting last patient in the earlier part of 2022 on the Lighthouse trial. And we see a number of other things that will contribute to our progress that will impact the label, impact perceptions of Melfluffin and to expand our opportunities in bringing new peptide drug conjugates to patients throughout the world. So I think I'll stop there and we'll move to the question and answer phase of the call. So thank you. Thank you. Our first question comes from the line of Victor Sundal Collier. Please go ahead. Your line is open. Yes. Hi, and thank you for taking my question. So you said that FDA will come with their decision on a Sunday. Do you think they would press release if either a CRL on approval came during the weekend? Or do we have to wait until Monday? Have you looked at any other approvals and so on? Maybe understand that better. Yes, good question. Yes, I think it's look, it's just the kind of the way the math worked out the calendar worked out. I don't think there'll be anything on a Sunday. So we would more anticipate something either on Friday or Monday, but there's no real way of telling. That's what the assumption we're on track. And from our perspective, everything seems to be in place. But you never know until you get there. But I would not expect that to happen over the weekend from an FDA perspective. Okay, great. And on Ocean also a question. Could you perhaps be a bit more specific what kind of discussions you would have with the FDA if you would reach non inferior results? Have you had any strategy in the mines since before and how you would approach that results to the FDA in order to get approval? Yes. So I'll start and then maybe ask Vas to comment. So from an FDA perspective, the typical agency response is it will be a data driven decision. So, I think it's a matter of let's see the data, the compelling nature of the data. This is a large trial head to head comparison against a very important and growing product pomalidomide now, dollars 3,000,000,000 worth of usage around the world. So very important drug in multiple myeloma. We're excited about the opportunity to show that either non inferior or superior to it in the selected patient population. So I don't know that I could say anything above and beyond data driven decision, but we certainly would be encouraged by something a hazard ratio that doesn't quite meet the 0.8 and believe that that would open up an interesting discussion with the agency costs. Yes, I completely agree, Marty, I think one thing to consider there is that there will always be a decision on the benefit risk totality. And this is where it's good to keep in mind the very tolerable nature of Nalpruitment. So this will not only look efficacy, which in itself is already would be, I would say, stunning if we would beat pomalidomide, but It will also then look the agency will also look at the safety there. And we feel we have a very good and tolerable drug there. So guidance, the general picture that I would take. Yes. I got the question on the hazard ratio. I think before you communicated, if I don't remember it, if I'm not mistaken, that the asset ratio or the primary endowment was a asset ratio of 0 point SEVEN. Is that not correct or The hazard ratio where we reached yes, the hazard ratio where we reached cyclical significance as 0.8. Okay. Okay. Thank you. Thank you. Our next question comes from the line of Chris Worriede from NBB. Please go ahead. Your line is open. Update. Thank you. I have a few short questions. So can you comment at all on what you see as the likelihood at this point, very close to FDA decision of getting either the data or language in the actual indication on the label for extramedullary disease, subtypes or high risk cytogenetics. And then I guess I just roll them off. In terms of potential to expand Anchor to add more arms basically other combination of possibly larger groups. Is that something for us to look forward to? And then might you do a trial just collecting stem cells after melflufin exposure to try to an easy relatively low risk way to demonstrate difference from Melfolan. Those are my questions. Thanks. Okay. Thanks, Chris. I'll take the first one and then turn it over to Klas. So certainly commenting on the specifics of the label and where we're at is not something I'd feel comfortable with at this point in time. I think from a general perspective, if we think about the RYISON trial, we took on all comers and really had a high percentage to patients that were extramedullary disease, a high percentage of patients that were high risk. We outlined at the ASH program, high percentage to patients that were out delayed or refractory and what we see is the consistency of efficacy and benefit that benefit risk profile throughout those subpopulations. It's important to note that with an accelerated approval, One typically does not get subpopulation called out specifically in any way from an indication perspective. So it probably is unreasonable to think about those types of callouts, but the opportunity again to promote reflecting on the Horizon trial and those patient types that were in the Horizon trial. We would believe we'd have the opportunity to promote specifically to those patients. Class as it relates to the anchor expansion? Yes. Thanks. Very good question. Yes, we are looking at other combinations as well other potential combination. With regards to the daratumumab and bortezomib arms, those won't be further expanded on daratumumab. We basically expanded with the Lighthouse trial. Should the results of the bortezomib arm also be that compelling. We may build on the results there with bortezanib. But in the meantime, we will also adding newer agent to look at the safety and efficacy there as well. On the question about looking into the bone marrow of patients. Yes, we are actually amping up our translational research in general. In the company, we have now established a translational research group as well. And one of the things that we will be specifically looking at It's the impact of notifen on the bone marrow, but also on the clonal evolution before, during and after treatment. So a very good question and yes, we look into that. Okay. Thank you very much. Thank you. Our next question comes from the line of Rene Badish from Kempen. Please go ahead. Your line is open. Hi, guys. Thanks for taking my question. 2, the first one is with regards To the planned future studies, do you have certain BiTEs or CAR Ts already in mind for the multiple myeloma combination study? And will you choose 1 compound to combine with or do you rather want to do study with milk for combos? And then I have a follow-up. Unable to comment on the specific agents that we have in mind, but we're actively investigating various options there. We're looking for in principle, we're looking at a compound which we believe is the best combination for meloxicillin and not so much as a signal seeking trial with various compounds. I hope that answers your question. Yes, that's helpful. And then the follow-up question is about your strategy in Japan. You elaborated already a little bit to it during the call, but When do you expect that we can have more specific guidance and or a partnership being announced? Could you just repeat the first part of that, Renee? I missed the Yes, sure. So I think you already elaborated on some of the plans that you have in Japan for Malthusen. When can we expect to hear more about that? Yes, I think as we've Looking at the major inflection points and milestone, our focus has been on kind of the U. S. Launch and then the ocean data being a big driver of potential value, whether that be partnerships in Japan or thinking about other regional opportunities. So our focus has been on those two milestones, but we'll begin shifting our attention. Obviously, with approval in the U. S. And moving forward in Europe, getting the patient getting our product and leveraging the results of the trial and the OCEAN trial as quickly as possible, will become more and more important to us and those other geographies will come in more focus in the quarter or 2 ahead. All right. Thanks a lot. Thank you. Our next question comes from the line of Boris Peaker from Cowen. Please go ahead. Your line is open. Good morning. First question on manufacturing. Can you comment who manufactures melflufin And what are the key steps or if there are parties involved? And has FDA inspected the manufacturing facilities already? Update. And I'll volley that one to Anders for us. Good morning to you or good afternoon. So the drug substance is produced by Chemo Sweat in Southern Sweden and the drug product is currently produced by Cenex C in Belgium. Cenex C in Belgium have been inspected by the FDA in the beginning of 2020. So we're not expecting a repeat of that inspection for our approval. Update. Got you. And my second question, in terms of the commercial expectation, I'm sure a lot of investors are going to be looking at XPOVIO as a guide. Is it reasonable to anticipate you guys to beat exovio even in the first initial few quarters? Or how are you thinking about that? Well, I think as we good question. I think as we look at the profiles of the 2 drugs, we believe our drug is superior. Obviously, we're launching into a little bit different marketplace with them being a competitor that they didn't interface and also belantamab being approved in the space. But certainly our ambitions mid term and long term for sure our that we see melfalutin being a superior backbone product with at risk profile that we think is better than selinexor. Great. Thank you for taking my question. Update. Our next question comes from the line of Peter Welkert from Jefferies. Please go ahead. Your line is open. Hi. Thanks for taking my questions. Got a couple. So firstly, if you just get on Anders, I think on the cost base. Just curious, I think I'm right in saying and you cut out a bit, but I think you said sales and marketing will likely further grow on the 4th quarter run rate. I guess just curious does that You do continue hiring in European infrastructure or is that just based on the sort of the U. S. Alone? And I think you said the U. S. Is 3.29 of the spend this year, but if you could just confirm that, that was the number you said. And then just continuing in Europe, you obviously gave some helpful details in terms of the field based team in the U. S. Any sort of initial guide you can give us in terms of what you were thinking in terms of Europe and how that theme may differ in size versus the U. S? Update. And then just lastly, just with regards to when we think about the Ocean readout, I guess curious there in terms of what you'd give us in terms of the granularity there. Should we anticipate just a headline press release or are you will you provide more details from that do you think in the press release that was announced with the decision there? Sorry, just finally as well on the U. S. Approval. Are you ready to go ship drug, get on the ground as soon as the 28th February whenever this happens? Or Should we anticipate a little while after that before the actual first patient is able to receive drug in the U. S? Thank you. Yes, I'll take the last one first and maybe go over to Anders on the costs. Well, maybe I'll touch on the European just a little bit, then I'll turn it over to Anders on costs and to Klas on the Ocean Point. So yes, within a couple of weeks, I would say, there's the once we get the approval, we have to print the labels, put the labels on the drug and then get them into distribution system. We believe that that can up within 2 business weeks. So there won't be any big delay there. As it relates to Europe and the projections on sales force size, too early to tell. There are different ways in which our strategy can go. Stay tuned on that from a go forward basis. Maybe this ties a little bit into what Anders will talk about. But As our strategy plays out on the regulatory front, we will phase in investment accordingly. So right now, we don't have a big build in Europe that's currently in the plan. That will be based on the opportunities, near term opportunities playing out. So with that, I'll turn it over to Anders to touch on the costs. Thanks, Marty. And yes, so starting then with the $456,500,000 that we had in marketing and sales costs in 2020, roughly you're correct, roughly 329 of those were in the U. S. And to then look try to figure out what's going to happen in the 2021. It's probably more relevant to look at the Q4 cost of SEK 173,000,000. That number will increase somewhat. The full organization was not there the full quarter in the U. S. So we will see some increase in the U. S. And we'll add some positions in the U. S. During the year. And then towards the end of the year, we opportunity. We will most likely have some people in Europe. It really depends on what happens update in terms of EMA approvability, if we can get accelerated approval or not. So we're not sure really what will happen there. But if you assume that we will go up maybe around 15% from the Q4 rate and apply that as a proxy for next year, that probably gives you the right ballpark figure for the full year number. Hope that helps. Klas on the Ocean results? Yes, sure. And you may appreciate that for these types of big Phase III studies, it's an awful lot of data that comes in at various time points. So as soon as we are able to communicate the primary endpoint and when we reach that or not, that will be something we press release for more detailed data. We would anticipate that to be shared at a conference in the future. Update. Great. Thank you. Thank you. We have no more questions I will hand it back to our speakers. Okay. Thank you and thanks to everyone. Obviously a good quarter for us and looking forward to even a more exciting Q1 here in 2021 in the 6 weeks that or so that remain. And certainly, I've been doing this for a long time and I can look at 2021 from an oncopeptides perspective and hear out of the gate with a Phase 3 readout in the first half of the year, potential U. S. Launch, progress in Europe, really, really exciting year. So look forward to continuing to update everyone on the story and the milestones as we move forward with our ambition to bring melflupine to patients around the world. So thank you for continued digging in and covering oncopepides and look forward to future discussions. Thank you very much.