Earnings Call: Q1 2021

May 26, 2021

Thank you and good morning to everyone. Marty Paul, CEO of OncoPeptides, really pleased to be with many of you again this morning, this time to talk about our Q1 results. And I'm sure we'll have the opportunity also to touch on some of the discussions from yesterday and the top line release of the OCEAN trial. So on Slide 2 participants joining me in today's call are Doctor. Klosbacher, our Chief Medical Officer and our Chief Financial Officer, Anders Martenloft, almost gave him a promotion there. And on Slide 3 is a disclaimer. We're going to be making some forward looking statements. So please look online for fairness, accuracy and balance. And let's move then to Slide 4. So I think the key takeaways that we want you to walk away from on this update is that we are excited about the launch of COPAXONE in the United States. It's off to a very strong start. I'll provide some details regarding things like the awareness of our drug among our targeted customers, which is at 90%, which I think is pretty much where anyone would be happy with that level of awareness. In terms of our reach to customers and I'll talk a little bit more about this as it relates to COVID-nineteen. Over 90% of our top tier targets have been reached as we've reported in the in our release. And we opted to provide a little bit of clarity and a lot of my discussion will include April, because the view was 6 weeks of ramp would be much easier to interpret. So you see in our release $2,300,000 of net sales in March followed by an increase to $3,300,000 in April. We are on track. We track our uptake relative to number of unique accounts. We think that breadth of prescribing the drug is really important. And we match this against the highest performing analogs in relapsedrefractorymultiple myeloma. And we think the fact that 6 weeks in, we have 100 unique accounts ordering the drug. We believe that to be very strong. We know that the Phase 3 OCEAN data with the positive top line results, this comparative data versus pomalidomide will certainly have an impact when this data is presented in a peer review conference and we'll begin to change what's already a very strong perception of COPAXONE in the market. So I'll provide some glimpse of some primary marketing research here that will kind of provide some perspective on that. And we think those two things combined put us on a path to make propaxel a foundational treatment in relapsedrefractory multiple myeloma. So the next slide is our agenda. So I will talk about the launch success and building momentum. Then Klosbacher will provide an R and D update, include including a reiteration of the Ocean top line results and some of the key highlights from an R and D perspective. And Anders Martin Lauch will provide the financial update, our quarterly results, milestones, news flow and some adjustments to our calendar as it relates to future earnings calls. So with that, I'll move into the launch update and we can flip forward to Slide 7. So just as a reminder, we were very pleased to get accelerated approval on February 26 by the FDA. Just as a reminder on the labeled indication, it's in relapsedrefractorymultiple myeloma, triple class refractory population and patients who have received at least 4 prior lines of therapy. So this was based on a subpopulation from the ORISE and study, a group of 97 patients, which included a very high percentage of patients with extramedullary disease. So as we've kind of talked about the see data in the marketplace. We certainly point out that this is a group of patients with extremely high unmet need. And as we released early to keep it in perspective and why I talked about 6 weeks of drug availability is the commercial availability of COPAXONE began around March, March 15. So very expedited product of getting or process of getting the drug into the U. S. Market through customs, labeled into our distribution channel and ready for patients to be treated just in a couple of weeks. So very excited about that. On Slide 8, just wanted to provide a little bit more clarity on the account based approach that we're using to ensure an optimal customer experience. And I put into the slide here the size of the footprint that we currently have with our oncology account managers, sales representatives approximately 40 spread out across the country. And really, we see them as the quarterback in terms of our customer interactions. But they have a tremendous amount of support around them, including key medical affairs functions, the medical science liaison team of about 10, oncology nurse educators, which are doing that team is doing a fabulous job in the marketplace, helping with dosing administration, talking about side effect management, etcetera. So really outstanding group have nurses that are also helping our oncology account managers. We have some key customer marketers that are really driving a lot of programming across the country, be that through advisory boards or other group customer meetings, speaker programs, they're doing an outstanding job. Of course, we have a headquarters team here in Boston and also a team of national account executives that includes the market his team and we'll talk about the great work that they've done, making sure that every patient has access to COPAXO in the U. S. Marketplace. So we've also included a series of pictures here and that's really a statement about the changing environment here in the United state and really excited about that, launching into a COVID world that is evolving. And with that comes a different experience as it relates to interacting with customers. I would say, by and large, we're moving from a 20eighty mix of in person to virtual to more of a fifty-fifty blend. And we do see the light at the end of tunnel the tunnel here in terms of this normalizing in the United States. And I've had the pleasure of joining Mohammad Lada and our leadership team to meet with our sales team, field team around the country and talk about the launch of COPAXONE and also take the opportunity to meet with customers when we're able to do so as we do this tour. So moving forward to Slide 9, want to provide a reiteration of our strategy. And our strategy is really a 2 pronged approach now being one of the drugs that's approved with in the triple class refractory marketplace for multiple myeloma. On the left hand side, we see those 3 classes that dominate the prescribing pattern over the past decade plus the image, the PIs, anti CD38 led by daratumumab. And in today's marketplace, we see mostly a recycling of these classes through the patient the management of a patient through many lines of therapy. But now we have the availability of products with new mechanisms of action and we joined that class as Popaxo. We also have belantamab, selinexor, Idecel or Vecna that has launched recently. So our 2 pronged strategy is first to position ourselves strongly and become a treatment of choice amongst these products with new mechanisms of action. And the second strategic initiative here is to stop the recycling of old classes. And that ties directly into the results that we see in the OCEAN trial. Keep in mind that trial is in failure in patients who have failed lenalidomide and we see a randomization to a new mechanism of action, COPAXO, or the same mechanism of action with pomalidomide. And the results that we shared yesterday show that the patient experience, ability to induce a response, a longer progression free survival is improved by switching mechanism of action. So certainly, we will use that Phase III trial as we move forward to help bolster this strategy and expand the use of propaxone. So moving forward to Slide 10. So to reiterate some of the numbers here in terms of being off to a very strong start. So as it relates to our revenue metrics, the $5,600,000 in net sale is over the 1st 6 weeks of commercial availability. I had mentioned the number of unique accounts, 100. We'll take a look at some of those accounts, high profile accounts, both in the community and academic center. And also that we've shipped greater than 700 vials of Copaxone, the 20 milligram vials into the distribution channel here in the United States in the 1st 6 weeks of availability. As it relates to the field team and the activity of the field team, the team is doing an excellent job prioritizing and meeting with top tier customers. We've seen more than 90% of our targeted top tier customers in this 1st 6 weeks. As mentioned, a 90% or greater than 90% customer awareness among this target audience is excellent and the payer coverage at 97% highlights some of the other key metrics and key successes out of the gate here with the launch of COPAXONE. Moving forward to Slide 11. We were very pleased just a couple of weeks into post approval, post accelerated approval in the U. S. At the NCCN, include COPAXO in the guidelines, Category 2A, uniform consensus that COPAXO is indeed a treatment of choice for relapse and refractory multiple myeloma. So certainly that's helping us to build confidence, become part of pathways within the United States treatment community and will also help us on a global stage to build our product. Moving forward to the next slide. So a little bit of color here on the payer coverage with 97% of payers covering COPAXONE to the label or better. So in this particular case, I'm pleased to report that we've had 0 coverage issues in the 1st 6 weeks of product availability. And this is really a tribute to the outstanding early payer engagements by that national accounts team that I talked about. So tying in the first bullet point here, the number of interactions, compliant interactions that occurred to help prep the marketplace, convey results of the horizon trial to payers, paving the way for this coverage to be seamless to make sure that the product was available to customers upon launch. We're not seeing any issues as it relates to payments to providers. We're very pleased to see that the Pacsto is on 98% of electronic medical record systems by the end of April. So just reinforcing the bottom line here is no reimbursement challenges to date. We're extremely excited about what that means in terms of patients who need propaxo are able to get propaxo. So turning to the next slide, just want to reinforce on this 100 unique accounts, a really impressive breadth in the use of pacaxone. And we've talked about the importance of academic centers, but also community practices based on the profile of our drug. And as we look at some of the who's who as it relates to both community practices around the country as well as academic institutions, I see I think you see a very impressive snapshot of some of the customers that are utilizing COPAXONE today. So on the community side, the standout, Florida Cancer Specialists, Texas Oncology, the Cancer Center of Kansas, and you see some of the premier academic institutions in Memorial Sloan Kettering, Dana Farber here in Boston, MD Anderson, UCSF, University of Pennsylvania and others. So really pleased with the breadth of experience being gained, a number of unique accounts. This is going to help fuel sales trends in the future. The consult of academic physicians gaining experience with COPAXO and their discussions and influence on community physicians is all part of this uptake process through the launch of a drug. And we feel we're in a very good and growing position as it relates to that. Flipping over to Slide 14, just wanted to provide a little bit more detail around the targeting and the execution by our standing field sales team. So on the left hand side of the slide, you see from an account perspective, there are about 5,200 accounts that we are targeting. From a priority perspective, it's about 1500 that are most important. And we believe those 1500 represent about 80% of the multiple myeloma prescribing activity in the United States. The breakout here is about 10.50 of these accounts are community based accounts and 450 are academic. And on the right hand side of the slide, you see in the bar chart, the percent reach from our sales team that's been achieved through the 1st couple of months of availability. So this is through the April 30 time frame. So as an example, the decile 9 to 10, 94% of those targets have been called on at least once during this 2 month time frame, 91% for DUSAL seven and eight. So very pleased with our execution and calling on the top accounts. Flipping over to the next slide. Looking at the messaging and key customer insights, we feel that the receptivity to our drug and the messaging has been very strong. The unique mechanism of action is playing out well. This balance of efficacy and tolerability and also the convenient dosing schedule is a key part of that. The unique mechanism action, of course, we're emphasizing this peptide drug conjugate platform and all that does in terms of allowing for the cytotoxic payload to be more preferentially delivered directly into the tumor cells, emphasizing the strong efficacy, emphasizing the indication statement, patients eligible for therapy, the manageable safety profile of the drug and the ease of use in terms of this once monthly 30 minute infusion schedule is all playing out quite well. On the next slide, this is interesting data that comes from a proprietary marketing research that I mentioned earlier at the outset of the call. And his study was done last month with approximately 60 physicians that are on our call list. And these physicians were asked to rate the attributes, several attributes as listed here on the slide for individual drugs. So in this case, it's a comparison of propaxo to pomalidomide. They were asked to rate these drugs on a 7 point Likert scale, where 1 was the drug does not exhibit strong attributes in this area. And 7 is stream the drug or this particular attribute is extremely strong for the drug. So the ratings here are the percent of physicians surveyed who deemed on the 7 point Likert scale that the product was a 6 or 7. So very strongly related on the attribute. So two observations comparing propaxo to pomalidomide. I think on one hand, we can say that what a great job the team is doing from our publications team to our sales team to our MSL team in terms of describing the data that's available on COPAXONE, the top two boxes are very strong as it relates to propaxo on progression free survival, overall survival response rate, duration, etcetera. But we also see that we fall short of pomalidomide, not unexpected, right? Pomalidomide is the most widely prescribed drug in relapsed refractory multiple myeloma. So I think this then speaks to the OCEAN study and having a head to head comparison with the leading drug in the category will help to drive the perception of COPAXONE relative to pomalidomide forward. And we believe that what occurs when that happens in terms of mindset his preferential choice of one drug over another. So we're excited about where we sit today as it relates to the perception of the drug, but have also great hope as we look to build, propaxo as a foundational treatment in relapsedrefractory multiple myeloma. Looking forward to the next slide, just want to emphasize the fact that we believe we're particularly well position in community based care. Obviously, the academic market will be important to us, but just wanted to provide a little bit of flavor on the community based care. So on the left hand side of the slide, you see the use of doublets like COPAXODEX and the percent by line of therapy. And what you see is that the use of monotherapy or doublet therapy is much higher in later lines of therapy. That plays well to our profile, our approval, efficacy in later lines therapy, manageable safety profile, convenient administration and better compliance as we look into the later lines of therapy. And we're really pleased on the right hand side of the slide. But when we look at the accounts, the 100 accounts that have prescribed the Paxo or unique users of Paxo through the 1st 6 weeks. 65% are in the community setting and 35% in the academic setting. So we are beginning to build that footprint and add uptake in the community setting where we feel our product will play particularly well. Of course, we also want to be in the academic centers and and our development plan is focused to help us in creating data on combination usage that will also improve utilization in that area. Flipping forward to the next slide, I touch just a little bit on the European organization and what's going on there. So we're excited about our progress as it relates to Europe. The top hand slide top portion of the slide focuses on some of the communication we've had regarding submission. But here we forecast when we expect CHMP decision and potential approval of the product in Q2 of 2021. So likewise, below that, we are beginning our organizational buildup. We've announced the hiring of our outstanding leadership team in March of 2021. We're in the process of doing the work necessary to prepare for launch readiness in one of the early launch country, so which of course will be Germany. So we are on track and thinking and projecting in terms of a launch in Germany in 2021. And I did want to highlight before moving forward that we do have an early this program that is now open in Europe. And I'm very pleased to respond that we have patients on drug in all of the each of the EU 5 countries. And this program is growing on a month to month basis and we're really excited about the interest. It really speaks to the again to the global unmet need, in this particular case, the unmet need in the EU and the positive receptivity to a unique agent like COPAXO in Europe. So very excited about the groundwork being laid in Europe. Flipping then to Slide 19. So we're off to a great start with our launch. We're really excited about, of course, how our clinical development program ties into expanded market and expanded market opportunity. Ocean, we talked about pomalidomide, the largest one of the largest drugs or the largest drug in relapsed refractory multiple myeloma. Dollars 3,000,000,000 worldwide over $2,000,000,000 in the U. S, dollars 600,000,000 in sales attributed to the Palmdex combo. And of course, with our strong Ocean results, we see ourselves playing very well against pomalidomide. And from a future perspective, we are linked to DARZALEX. So daratumumab is a $4,200,000,000 product. And we see an additional 600,000,000 of utilization of the Palmdex combo adding daratumumab. So again, Lighthouse points to a major opportunity for us to impact more patients. So we look forward to realizing that as we continue on path of making COPAXO a foundational treatment in relapsedrefractory multiple myeloma. Slide 20 is one we've highlighted before. So with the horizon data, triple class refractory population being about 20,000 plus, average duration of therapy when we look back at the HORIZON study and patients in these later lines of therapy according to our progression free survival would be in the 3 to 4 month range. When we look at moving up in line of therapy, not only do we increase the eligible population in the case of Ocean, the 3rd line plus, but the average duration of therapy would also increase. The same to be said for Lighthouse as we see from the ANCHOR study, the triplet combination of pacaxo dex with daratumumab provides a longer duration. So really excited about the continued work on the Lighthouse trial. Flipping then to Slide 21, just to put this in picture again from an ocean perspective, pomalidomide, the largest drug. We see the strong sales growth from 20 $16,000,000,000 to $20,000,000,000 in global sales in 2020. On the right hand side of the slide, from the intrinsic data set, we look at the 3rd line plus patient market share and the portion that is highlighted in the top right hand corner suggests that 33% of the use of or 33% of the patient market share is somehow tied to a Palmdex combination. So that speaks to the great opportunity, the significant opportunity that is the data with the OCEAN trial. To slide 22 kind of brings that fully into scope. We have a very an emerging profile, a growing and improved profile as we commercialize the drug in later lines of therapy and the profile will continue to improve as we create and generate new data in earlier lines of therapy. Ocean is the start of that, really setting a new bar with head to head positive head to head comparisons to pomalidomide. Lighthouse will be our entree into combination therapy. So I'll stop there and turn the conversation over to Klotz to talk about the Ocean top line results and some of our key R and D highlights. Thank you, Marty. And I'm more than pleased to be able to speak again to the Ocean top line results. And if we go to Slide 24, we see the overview of our clinical development program, which is currently ongoing. And When you look at the left, we see O12M1 followed by Horizon and then, of course, Ocean, which is meant to be a confirmatory trial for Horizon in the U. S. But also in the EU. In addition, we have ANCHOR, the combination trial where we show good combinability of maflucan with various other drugs Enbridge where we expect results soon in patients with renal impairment. When it comes to the administration mode, peripheral versus central infusion, port does provide data this year, which will hopefully support the use of Noflutin also via a peripheral catheters. Lighthouse, as mentioned, an important opportunity, and I will speak about that a little bit more. Well, ASCEND is our first study and another indication being AL amyloidosis. Now let's go to Slide 25. And this, again, are the top line results for the primary endpoint and progression free survival. And before I jump to the table, I think it is important to stress that once you do an add on trial, so if you have a triplet versus a doublet with a hazard ratio of 1, that means the addition of the new drug does nothing. It's equal. So if you then look at successful drugs from a triplet perspective versus a doublet, you see a hazard ratio on average of 65 to 70%. So 0.65, 0.70%. Now what we do here with Ocean is comparing head to have. There is no addition. So it's really a highly active drug, omaledomite, where we actually, with COPEXTO overachieve with a more than 40% improvement in median PFS, vote for IRC and investigator assessed results. On top of that, if we look at the overall response rate, we see a solid above 30% number for melflufen versus a 26.5% for pomalidomide. And if we then look to the next slide where we try to put it a little bit into perspective, our results. And I think this slide is important, Slide 26. This is a slide which we showed earlier to talk about the various scenarios for Ocean. And if we went from the left to the right, that superiority, non inferiority, non conclusive and inferiority. So as you can see, the non inferiority bar in black, the lowest bar was kind of the average non inferiority result. If we look at the superiority bar, you will see that it just passes the 0.8 hazard ratio. If we then look at the actual Ocean results, you see that we actually are on that line of 0.8. So where we previously stated, we consider a non inferiority result a positive outcome when it comes to regulatory interaction because we believe the totality of the data speaks. And you'll see now how much we are into that non inferiority margin. Tipping over to superiority in the investigator test response. We are very pleased with this result. And we believe that and this is also exemplified by the early interactions that we have had with key opinion leaders. And with that, I mean, investigators in the trial who have been able to see the full data set. So because we are discussing it for publications, for conferences. And so far, also when compared to yesterday, there is consensus that if you look at the numbers, if you look at subgroups, etcetera, melfthufen clearly beat pomalidomide in this trial from a physician's perspective. Looking at the data, everyone, every single physician I spoke to Was very impressed with the data. Hence, our commitment to bring this data forward to a scientific conference as soon as possible because we are eager to show the full results, which we believe are truly strong. We then go to the next slide, Slide 27, the safety summary. Now this was an area of concern for some KOLs with Ocean, where they thought that pomalidomide would have a much better safety profile. It's a daily pill. It's considered to be very tolerable. And then we add an intravenous new peptide drug conjugate with relating properties and how could we stack up against pomalidomide, especially given the relatively high number of hematological tox, which we call paper tox because so far it hasn't translated into more bleedings or infections. And the fact that we, in Ocean are able to confirm the safety profile. Maflufen is just very positive because that again means that the AEs were very much clinically manageable. And from a physician perspective, this is important. Pomalidomide, and this is really a surprise for physicians had more infections than nalflutane when you talk about Grade 3, Grade 4 infections. There was a significant delta here despite naltfluthing having higher levels of neutropenia. So we are very encouraged by this result. Similar levels of other non hematological tox, no outliers there. And importantly, the discontinuation rates were similar. So despite the on paper, more tolerable profile of pomalidomide and the expectation of pomalidomide being a more easy or tolerable drug does not turn out to be true in Ocean as the discontinuation rates for adverse events were similar in both arms. So if we go to Slide 28, what does this mean for our regulatory interactions? And I know this is an area of high interest for everyone, but I can tell that we are currently in the process engaging the FDA on the OCEAN data. We are planning for presentations at key conferences and the publication is already in progress. We will file a supplementary NDA in Q4 2021. Preparations are underway, and we feel very strongly that in light of the totality of the data of the OCEAN trial that we will not only ask for full approval, but also for a label change to earlier lines of treatment. Now this is not a given, but we feel very confident given the totality of the data that we have seen and we have pressure checked it with KOLs. This is a really clinically meaningful result that we show with Ocean. In the meantime, of course, we continue to focus on our commercialization efforts with Putexo in the U. S, as Marty already alluded to. But if we then go to the next slide. This is already our next Phase III trial, Lighthouse, currently enrolling. And also a randomized Phase III, melflufen plus daratumumab versus daratumumab, and this is really based on the positive data that we have seen from Anker. The aim is to enroll 2 40 patients, again, with a primary endpoint of PFS, and this will give us a significant opportunity to increase the market potential. And if you then think about the fact that the current combination of pomalidomide, terexetimlimab, dexamethasone is used very often relapse refractory multiple myeloma. And one then considers the fact that we performed better than pomalidomide in the OCEAN study. There is an easy lab to think that if we then show a superior outcome in the Lighthouse study that a combination with daratumumab is really feasible. Then if we go to Slide 30, I'm very pleased to share that we have been accepted by EHA for several abstract. One is the BRIDGE study, and we are looking forward to share this data because we believe that we have a very tolerable drug also in patients with renal impairment, and we are looking forward to present the data set off bridge at EHA. We, as previously announced, have also been looking into other indications or we are aiming to look in other indications. And here at EHA, we laid a foundation from a preclinical perspective showing high efficacy in cytarabine and venetoclax resistant AML models. And as you will know, or otherwise, I will mention it in two slides, we are aiming to start our AML study later this year. Also for DLBCL, we see some very encouraging preclinical data that will also be presented at EHA. And then really for regarding the new mode of action. Mofluthen is considered to be an alkylating drug, what we know it is in the nuclear, but there is no drug which has shown activity in the mitochondria. And if we look at that, it seems that naflufen also works on the DNA in the mitochondria of the cell, actually providing proof that it not only easily transfers the cell membrane, but it also actually easily passes intracellular membranes, which is very important if you want to have cyclotoxic effects not only in the nucleus but also to the mitochondria. Then at ESCO, Slide 31, ANCHOR. We will have a new update of ANCHOR data, which particularly now also more data in the bortezomib arm. Lighthouse, an ongoing trial abstract where we will express full confidence in this study. And then we will have the pooled analysis of the O12M1 and Horizon study where we looked at the activity of Merckinfen relapsedrefractory multiple myeloma with alkylator news. This is important since we believe that this is a key differentiator form a fluthen when compared to alkylating drugs who would normally not work in this patient population. So when we go to Slide 32, our planned future studies and new indications. As mentioned, AML, high unmet medical need, OS less than a year, and we will have a Phase III study in relapsed patients where we expect a first patient in the second half of this year. And then the same is true for the FUTURE STAR2 B cell lymphoma, high unmet medical need in the relapse setting and this is also where we expect our first patients in the second half of twenty twenty one. But we feel that we built a foundation with Ocean where we can now build from further to validate our peptide drug conjugate platform. And with that, I'm happy to hand over to Anders Martin Luft, our CFO. Anders, over to you. Thank you, Claus. If you turn to Slide 34, you see the numbers for the Q1, and I'm happy then to be able to report revenues for the very first time. However, it was only for 2 weeks. So the SEK 19,400,000 that we reported are not representative of the full quarter of revenues. So that's why we also presented the April data to give the shareholders some indication on where we are heading in terms of revenues. And for March, the revenues were $90,400,000 and for April, 28.0, I. E, dollars 2,300,000 $3,300,000 To give you some color, roughly 70% of that was real demand, so not much stocking. Gross to net reductions were in the high teens. So nothing strange to report there really. And it's really hard to draw any conclusions confirm these numbers. I think the most important thing in the beginning of the launch is having clinics trying the drug for the first time. So we want to have as many clinics as possible trying the drug and then when they have seen what it does for patients, they will start to implement or sort of expand the use of the bupag in early lines of patients. So key number here is to see that we are in a high number of clinics, and we're then really happy with the number of roughly 100 clinics that Martin talked about. So a really strong start from a revenue perspective. If we then turn to the cost, you see them on the left hand side of the slide. We, for the very first time in a really long time at least, so declining R and D costs going from $230,000,000 in 2020 to $178,500,000 in 2021, whereas our marketing and sales costs are, of course, growing, thanks to the buildup of the U. S. Organization that was just buzzing in 2020 and is now in full bloom in 2021. So roughly the same amount stands on R and D and marketing and sales. So operating loss as a total decline them from the Q4. So the operating loss was to SEK 348,000,000. It was SEK 5.11 million in the 4th quarter and EBITDA in the Q3. So a lot lower and that is then explained by the lower R and D costs where the Ocean costs went down from send the $8,000,000 last year to $49,000,000 this year. Cash flow from operating activities was 386 $700,000 So roughly $400,000,000 cash burn. And the cash position, as state in the balance sheet was SEK 372,500,000. However, that does not take into account the money that we raised through our capital raise that was decide this in March but concluded in April. So pro form a included the raise. We had roughly SEK 1,400,000,000 in cash. That does not include the EUR 40,000,000 loan facility that we have with EIB that remains unused to life. Turning then to Slide 35. You see the upcoming news flow or maybe I should state that we have had a lot of interesting events, and we have delivered roughly on time in the last few quarters, so we're really happy with that. If we look forward to what's happening next, we have the presentation of the ocean full data set at an upcoming conference that will, of course, be important. That's where we can really start to talk about the data to physicians, and that will have an impact also on sales since more and more doctors will learn more about the product, they are more likely to utilize it also in later lines. Later in the year, we will also then have a submission for Ocean in the Q4. And then turning to 2022, we can then get approval in the EU, as Marty already mentioned, with birth sales in Germany probably during the Q2. And then we hope to get the extended label approved in the U. S. In the second half of twenty twenty two. So lots of things coming up. If we turn to Slide 36, I just want to mention that we have revised our reporting schedule. So you see the times on the slide here. So the second quarter report will be available on August 'nineteen. That will then potentially be the first time when we can see more of trend lines in our revenues. That will be followed by the Q3 report when you see the 1st 7 months of sales on November 4. With that, I think I should turn back to Marty to sum up the quarter and where we stand on Slide 37. Thank you Anders and thank you Klas as well. So on Slide 37, just pleased to come full full cycle here in terms of being a fully integrated biotech company, again, going where not many not many get to be in terms of bringing a product from an idea stage through the bench enter the clinic and now into the marketplace. And we're just so pleased to be able to make that happen. So with Vipaxo, we are addressing a growing unmet need. We've had an outstanding 1st 5 months of 2021. Our center of focus is, of course, on the patients that we serve. I also want to recognize our Oncopeptides team and it comes down to our core values starting with the science. But the passion of the team, the courage of the team, the trust win one another and the collaboration is what's helping us to achieve these milestones. And we certainly appreciate the support of our investors as well. And with that, we'll move into the Q and A. Thank you. Thank you. Our first question comes from the line of Peter Welford from Jefferies. Please go ahead. Hi. Thanks for taking the question. Just two quick ones, please. Firstly, just with regards to the 70% real demand figure for the sales of the PAXTO that you cited. Was that relevant to March sales? Or was that referring to the March April period together? And then secondly, just on Lighthouse, wonder if you can possibly talk about the statistical analysis plan for the Lighthouse trial and the powering and what you're assuming for the hazard ratio to that study when you anticipate that could potentially read out with data. Thank you. Thanks, Peter. And the figures that I covered were comprehensive through the 2 weeks in March and the 4 weeks in April as it relates to the commercial uptake. And for Lighthouse, I turn that over to Klas. Thank you, Marty. Yes, for Lighthouse, we do expect currently to have the high level results ready by the end of 2022, beginning of 2023. With regards to the hazard ratio, we shoot for a hazard ratio lower than then 0.7 in that study. So I just threw it back to the sorry, the it wasn't so much the adoption. It is more of the comments at the end where I think the comment was that the sales figure that's been recognized in the P and L around 70% of that, which I can give you real demand versus 30%, I presume, is stocking. I just want to move in that the bit, sorry, that rather close to Is that just referring to the March period, the March sales? I'm sorry to answer that. I was referring to combined March and April figures. It's slightly above 70%, but it's really math. That's right. Thank you. Thank you Anders. And the next question comes from the line of Victor Sundberg from ABG. Please go ahead. Hi, and thanks for taking my questions. So first one on sales. You mentioned in your report that in April, you had sales of SEK 21,000,000. That seems kind of flat compared to SEK 90,000,000 for only 2 weeks in March. Any reason why we aren't seeing an accelerated sales curve? And maybe also what have you been seeing in the month of May so far to get a feel for what the sales curve look back. Thank you. Yes. So good question. And no, I wouldn't look at this flat. Remember, there's going to be a little bit of stocking that would take place in the 1st couple of weeks that would inflate the March figure. So I think that's the major explanation there. Okay. And And as it relates to Yes. Yes. Go ahead, sorry. No. If you had a comment on May sales, that would be interesting if you could give that. Yes. We're not going to go that foreign comment on May at this point. Okay. Yes. And it also seems like oncologists prefer PePax from the community centers that do not have access to, for example, REMS program. Any color on what like what the mix is for centers that prescribe the tax at the moment? Yes, so we know from the initial approximately 100 unique accounts that 65% are in the community. Okay. And then also I had some questions on Ocean since I hadn't the opportunity to take part in So you said that you would file for a supplementary NDA in Q4 'twenty one. Any reason for that time lag From when you report the results now. And what have you included in that time line? Like what kind of interactions have you anticipated? And what kind of additional data that you need to provide? Yes. Good question. And I'll start then turn it over to Klav. So there's not much time lag there. If you think about we just got top line results to just a couple of days ago. So fairly standard practice, but I'll let Klas fill in some of the details. Yes, right. And with the planned submission in Q4, there's actually no delay. Actually, the work for the submission has already begun way before the Ocean high level results. It's just getting to clinical study report, which in general takes between 2 3 months before we have digested the data and have compiled a 200 page study report. And then that needs to be translated in all kinds of modules for the FDA filing. I would say from a pharma perspective, the get the timeline that we're having is pretty aggressive, basically from the high level results to submission. So there is no time left. There is no need for new data. We're not waiting anything else. We do have the data in hand. It's just that we now need to better understand them and put them into the right context for a submission. So the data that we need, we have. Okay. Because they are thinking of your CARiFirm, when they get Got their BOSTON trial. It just took 2 months before they filed for an sNDA. But of course, they met their primary endpoint to them. Is that the reason why If we would have met our superiority, compare IRC that would not have changed the time lines at all. We are working for exactly the same time lines independent of the study result. Of course, if the study was negative, that would be another study. But now that we have a positive study, we believe the time lines do not change. Why Karyopharm did it in 2 months, I cannot comment on. But the 5 months that we're talking about here today is quite typical. So I have nothing else to comment on there. Okay. And also, what have you pre agreed with the FDA if you would read out non inferior. Are there any agreements in place, what that would entail and so on? Or is it more oral agreement between you and FDA for what would have happened in that case? Well, it has always been on the table. And based on a non inferior results, the agreement is to look at the totality of the data. And one can imagine that if you have a non inferior result with a hazard ratio of 0.98 or 0.96 with a safety signal, then the FDA may not be that eager to give us full approval based on a non inferiority. Hence, they didn't want to sign up beforehand for a non inferiority study, giving us full approval. They would instead look at the totality of the data. That is the agreement we have. Now if you look to our non inferiority result, we are doing like the best non inferiority result you can have. We're tipping against superiority. So the efficacy is really there. And on top of that, we do not see any safety signals. In contrast, we are seeing less of some severe complications that are seen with pomalidomide. So when I say that we are very confident and positive in our interaction with the FDA, that is based on previous interactions. And if you look at the non inferiority result, it's not just non inferiority, it's also within non inferiority where are you. And on a scale from 0 to 100, we are almost close to 100 with this efficacy and safety result. Hence, our confidence for positive FDA interaction regarding our sNDA. Okay. And maybe also a question from a clinician standpoint. Most Pomalidomide regimens guidelines are for combination of this treatment setting after lenalidomide failure. What are the arguments that you're hearing for switching out pomalidomide to melsulufin if it's labeled non inferior, given that pom is oral and an infusion, Talk with the port as of now, as you've illustrated in your slides here. So very briefly, new mode of action, switching drug class is considered to be an important one. It's patient adherence with bill. You never know if a patient takes the bill every day. We know from oncology studies that even in the oncology setting, there is between 60% 70% compliant. Hear you have a once monthly infusion, 30 minutes. So you know the patient gets the drug, you see the patient and you know that the patient is treated. On top of that, and this is something that we hope to be able to disclose soon at the scientific conference, we have many efficacy parameters where we outperform pomalidomide. So from that perspective, the physicians that we've spoken to so far, say in this setting, I would clearly use moclufan over polynomial might given what you have just showed me. Yes, sorry. Yes, maybe another an additional comment there just around what we talked about yesterday was how important it is to establish single agent efficacy, right? And we did that with Verizon in a non randomized trial. So to randomize head to head, I mean, we want to be a long term foundational treatment in relapsedrefractory multiple myeloma. So with the starting point beating a widely used agent, the most widely used agent in the world is a very important part of that. So we'll build from there, right? We'll have combination data with daratumumab. As I mentioned, the Palmdex Dara combination is a big commercially used combination. We will have peptide data with Lighthouse. We have it already with ANCHOR. So it's one step in the process. But any drug that's an important drug in the oncology, hematology world has demonstrated very strong single agent efficacy. Okay. And how data driven do you think clinicians will be here at first since we do not have any data for a combination with Zemelfluff and elotuzumab and dexamethasone, just making up a combination here. For example, would perform against the same combo with Amalidomide instead that is supported by the Eliquent study in this specific example. Yes. So our immediate goals from a commercialization perspective aren't to switch out every Palmdex combo to with the Popaxto. Keep in mind the slide that I shared that was showing the concentration of doublet use in later lines of therapy, there's significant opportunity to play with a doublet. So establishing pacaxo dex as an important doublet and one that was a victor in a head to head trial is an important part of building the commercial momentum and uptake of the drug. And how much of doublet use is used after, say, previously lenalidomide failure or lenalidomide failure within a couple of months and so on. Do you have any feeling for that? Well, I could get back to you on some of the specifics. I think if you flip back to one of the slides I showed, we looked at Palmdex alone being 12% when we look across 3rd line and later. But again, you've got a very high proportion of doublet use in those later lines of therapy. Okay. Thank you very much. I'll jump back in the queue. Okay. And as there seems to be no further questions, I'll hand it back for any closing remarks. Fantastic. So thanks everyone for joining us for these exciting announcements. It was a great Q1, Q2 is shaping to be equally as strong, certainly highlighted by the ocean data, but also then our continue the commercialization. So really look forward to future interactions and really appreciate your support and interest in Oncopeptides. Thank you very much and have a great day.