Good day, and welcome to the Oncopeptides Q2 2022 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question you may press star then one on a touch-tone phone. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Jakob Lindberg, CEO of Oncopeptides. Please go ahead, sir.
Thank you very much and a warm welcome everyone, to this, quarter two webcast of Oncopeptides AB. Let's go straight to the disclaimer slide number two. As always, we're gonna make future-looking statements, et cetera. For anyone interested in the legal sort of weeds of this, just read the disclaimer. It's available on our webpage, and it's just the usual disclaimers, of course. Going to slide number three. With me today, I also have Dr. Klaas Bakker, Chief Medical Officer, and Annika Muskantor, Chief Financial Officer. We will all be available for questions and answers at the end of this session, obviously. Going straight to slide number four, we're gonna give a brief update of the quarter as such, and obviously it has been a very eventful quarter for us.
To some of you it might even have included some surprising news, not so much for us in the company, and we'll go into some detail of that. I'm gonna summarize some of the events. Klaas will go through very much of the regulatory pieces, which is of course the core of the update today. Annika will then go through the financials. I will wrap it up and then Q&A. Going to slide number five, the highlights. The big news this quarter and slightly afterwards is of course, that the CHMP issued a positive opinion recommending the full approval marketing authorization of Pepaxti in the European Union. We also got the news that this was after the second quarter that the FDA announced a new Oncologic Drugs Advisory Committee meeting for Pepaxto. That is a broad topic so far, the general benefit risk of Pepaxto.
This is scheduled for September 22nd. We have continued to advance our preclinical portfolio, which includes the follow-on compound to melflufen, OPD5, which is an improved version, and it's ready for clinical development. Obviously prior to this quarter, we had no financial resources to push the clinical development onwards, but that is something that we have started to plan for now. We have also announced a biologics construct that belongs to the NK cell engager platform that we call SPiKE, and all of these things have progressed according to plan throughout the quarter. Quite importantly, we also performed a directed share issue of a bit more than $40 million straight after the European approval. We did this to 0% discount, so at market, which under these conditions must be seen as highly unusual and a sign of strength.
With that, I will go to slide number 6. What are we now focusing on? We are of course trying to capitalize on the full marketing authorization that is expected by the European Commission within the next few days to commercialize Pepaxti in Europe. We are also working diligently on supporting the Type II variation for Pepaxti in Europe based on the OCEAN trial for earlier line patients. We expect to submit that and initiate the procedure at the end of the year. That's a 6-month procedure, and then of course a 60-day European Commission decision. Assuming that everything goes according to plan, that would lead to broader indication in Europe by the third quarter of 2023. At the same time, we are to some extent at risk creating the foundation for marketing of Pepaxti in the U.S.
We are currently not marketing this product, but we are building the infrastructure again so that we can deliver this drug to patients so that scripts can be written assuming that we have a positive outcome one way or the other with the FDA, which of course we don't know at this point in time. We are investing to make sure that it at least will be commercially available within a decent timeframe. This is different from full-blown commercialization, which we are not doing before we have more direction from the FDA of the U.S. We are obviously also given everything we have been through, working very hard to attract and especially retain good people in this industry.
We went through a very hard time from last summer until the European marketing authorization, where we reduced staff with basically 90% or so, and reduced our cost base very harshly to be able to reach that point in time because otherwise we would not have been. While we were confident in our science, there was a level of uncertainty, and now we need to sort of heal the wounds and make sure that we can retain and also attract new people as we slowly build the organization again. With that, I'm gonna leave the word for a regulatory update to Dr. Klaas Bakker, Chief Medical Officer. Thank you. Klaas?
Thank you very much, Jakob, and good afternoon, good morning, everyone. If we go to slide number eight, please. A quick recap of the CHMP positive opinion. This was unanimous, so all member states agreed that a positive opinion was appropriate for this product for triple-class refractory multiple myeloma. As you all know, this opinion is based on the phase II HORIZON study, but also the phase III OCEAN study was already used as a confirmatory study. Importantly, with this confirmation, EMA confirms that the overall survival data in OCEAN, which has a lot of intriguing results, is a case of true survival heterogeneity. This is important because this explains the directionally different overall survival results.
As Jakob alluded to, the European Commission will now very soon make a legally binding decision within 60 days after the positive opinion. Once granted, the marketing authorization is valid in the EU and EEA countries, namely Iceland, Liechtenstein, and Norway. We go to slide number nine. As you may have noted, we haven't press released this as we know this is not a material event, we have withdrawn the orphan designation of melflufen for the treatment of plasma cell myeloma. I will go into a little bit more detail here. When you want to remain or keep your orphan designation, you need to prove that you are at least comparable or better than products in the same indication. As you may know, we have been approved in patients with three prior lines.
With that, we are an earlier treatment opportunity than, for example, belantamab mafodotin or selinexor. That also means that the therapy to which we are compared to is CAR-T therapies. As you may know, response rate and PFS are extremely high for these CAR-T cell therapies. As such, we deemed it to be not feasible to show data showing equivalence or superiority over these CAR-T cell therapies. However, what I would like to emphasize is that this has no impact for our market exclusivity, no impact on pricing. The reason is that we also have already comparative data with pomalidomide with the OCEAN label. The orphan drug designation is valid or very useful when you only have a limited number of patients based on a single arm phase II trial, because then you need to really protect it with the orphan drug status.
In our case, that was no longer necessary since we also have the OCEAN data to support the full indication. I just want to make also sure that this has nothing to do with the orphan drug status in the U.S., since that is another framework. This was within the EMA framework and we decided ourselves to withdraw. Next slide, please. Slide number 10. We have the next big event scheduled for the twenty-second of September, the Oncologic Drugs Advisory Committee. Following the positive CHMP opinion, as we have stated before, we have had an intensified dialogue with the FDA, which is still ongoing. This has resulted now in the announcement of a public hearing with the FDA's Oncologic Drugs Advisory Committee scheduled for the twenty-second of September. Preparations are naturally ongoing, and that also includes third-party engagement.
What we mean by that is that we will also have speakers on behalf of us speaking about Pepaxto and the need for Pepaxto. The briefing book, which will give a little bit more flavor of the meeting, will be publicly available the third week of September, the latest twentieth of September, which is two days before the ODAC actually happens. Until then, and I think this is important to emphasize, we as Oncopeptides do not anticipate any public communication. The communication with the regulatory authority in the lead up to such an event is confidential, and until the briefing books are published, we do not anticipate to make any forward-looking statements with regards to the regulatory interactions we have with the FDA. With that, I would like to hand the mic to Annika Muskantor, our CFO. Thank you.
Thank you, Klaas, and thank you for giving me the chance to talk about the numbers. If I can ask you actually to go straight to slide number 12. Let's focus on the second quarter first. Now, the swift and decisive measures that we initiated last year have lowered costs significantly. The operating loss decreased from SEK -344.8 million- SEK -61.1 million. The largest decreases, as you can see, in operating costs is under marketing and sales. That decreased from SEK 204 million- SEK 10 million . To put those expenditures into perspective, it's worth noting that marketing and sales expenditures last year supported double-digit sales month-over-month throughout the quarter.
The costs that did remain during the quarter of this year are preparations mainly for market access in Germany and to some extent for the EMA application process. G&A has also decreased from SEK 41 million- SEK 17 million, which can both make sense given that certain administrative resources are still required to support ongoing operations. Anything above and beyond that, had been removed by that quarter. It's also worth noting that we are running a very tight ship, and the costs have continued to come down since the first quarter of this year. R&D has decreased but proportionately less and have gone from SEK 167 million- SEK 44 million. The R&D expenditures support our very important pipeline development, that Jakob alluded to previously, and the decrease in cost is mostly attributed to the tail end of cost to close studies.
You will, in the report, see net sales of SEK 8.8 million reported for the period, and that is for quite a reversal of a provision based on sales during 2021 in anticipation of possible returns after the withdrawal in the U.S. We will of course be very transparent as new sales are booked. At the end of the period, we had 44 employees. Of these, 37 were active, with various redundant employees at tail end of their notice period. On to cash flow. Cash flow from operating activities amounted to a negative SEK 106 million, which can be compared to a negative SEK 346.7 million for the corresponding period last year.
On the note of transparency, and given that the individual months cannot be discerned from a quarterly figure, I'd like to take the opportunity to actually now confirm, that the company reached the target announced in January for H1 of achieving an underlying operational burn rate of SEK 12 million-SEK 15 million per month, excluding remaining costs for discontinuation of clinical studies and expenses related to the EMA process. Also on cash, an update on the EIB loan, which is still under renegotiation. Simply in light of all the positive events during the summer, it is relevant to go back to the drawing board to align the discussion with our future needs and to match them with any loan-related obligations.
With that, I'd like to ask you to turn to slide 13, which will take us to the financial highlights for the first half of the year. Operating losses decreased to SEK 160 million, compared to a loss of SEK 692 million for the comparable period last year. Cash flow from operating activities decreased from SEK -733 million- SEK 272 million. I'll actually not make any further comments on that since the comments made for the quarter are totally applicable for the first half of the year. Of course, happy to take questions, but I am going to leave the financials on that and hand back to Jakob, please.
Thank you, Annika. Before we hit the Q&A, I would just like to leave a few concluding remarks and let's jump to slide number 15. We had a very eventful second quarter, and we actually expect no less of an eventful third quarter and probably a bit into the fourth quarter as well. Many events are ahead of us. We obviously gonna get the full approval within the next few days from the European Commission for the European Union and the European Economic Area in the next few days. We expect a potential resolution with the FDA near term. The ODAC is one piece in that, but also of course, discussions like Klaas alluded to, that are not public.
We will prepare and execute launch in Germany and German-speaking countries, and we will of course expect them both to communicate what is going on with regulators when we can. I know that Klaas alluded to this as well, that sometimes it's frustrating because we sit on half-baked information that might be relevant, and our silence is not because we want to be silent, it's silent. It's because we have to be silent. Unfortunately, this is just the nature of the business that we're operating in. We are continuing to develop our preclinical portfolio, and given everything we have been through, we expect towards the end of the year to be able to give much more clear guidance on exactly what type of commercial organization we're gonna build and where, and what that means for 2023.
We are right now building and running at the same time. It's just given where we were in the second quarter, which is a highly unusual situation, that we might actually be a company with more or less around mid-thirties full-time equivalents of people that are on permanent contracts and potentially have global rights to a fully approved oncology product in a major indication. You will simply not find an analog for that situation because it shouldn't really occur. It is what it is. We, so far, we have done the best I think we could possibly do with the cards that have been played to us, and hopefully, we can continue to use the trust that U.S. shareholders have put in us that we can continue on that path for the coming few months as well.
With that, I would like to open the floor for questions and answers. Thank you.
Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Adam Karlsson with ABG. Please go ahead.
Hello. Thank you for taking my questions. I have two, please. First, on the upcoming ODAC meeting, can you elaborate on what any of the specific questions are that the committee are tasked with providing input on? I know your constraint and what you can say, but specifically, I mean, are we expecting a vote on whether to lift the clinical hold, what the label amendment should be, whether the OCEAN study should be deemed confirmatory? Any confirmation on if any of those sort of votes are expected, or any more specifics would be appreciated if possible.
Secondly, a question on how you see the ESMO and IMWG treatment guidelines having been updated just last year, how that might be impacting the commercial launch of melflufen. The timing of those guidelines obviously meant that melflufen doesn't feature especially prominently at all, and the guidelines presumably won't be updated now for a couple of years. Your thoughts on the headwinds this creates for the uptake of melflufen, I guess in particular outside of the academic setting where melflufen was thought to have an edge, but perhaps where all the protests around the OCEAN study may not come to light. Your thoughts on that as well, please.
Yes. Thank you. I can give initial commentary and Klaas, please add if you would like to add something. On your first topic, unfortunately, we cannot give any guidance on the specific questions. It has to come from the agency. It's their questions, and it has to come through their briefing document and official communication. To the extent we know them, they have to be deemed confidential for us and will have to come from them. It's not because I don't want to talk about it. It's, I just can't to the extent I would know them today. To be frank, I don't. The specifics are not known to me now, but even if they were, I would not be able to comment on it.
As to the second question, I think that, while IMWG treatment guidelines and ESMO guidelines are relevant, I would argue that there are two different levels that are really relevant here. The first one is the NCCN guidelines that are updated more regularly, but obviously you need to come into the queue and be on schedule again, assuming that the FDA would come to a position where we would remain on the market in the US. The second is that in Europe, most guidelines are in reality national. The weird part with the national guidelines is that, as you know, in Europe, cost benefit is a central piece.
National guidelines are not just built on the clinical data, but also clinical data juxtaposed with the cost of the treatment, which of course they look a little bit at ESMO and IMWG, but ultimately treatment guidelines are very local. This also means that you will not be able to get a really good position in national guidelines until you have a price in that geography in Europe. As you know, that will take time. The first step for us is of course Germany, as we announce our price, opening price, since you have a 12-month free pricing period before you have the negotiated price.
I don't think that IMWG and ESMO will impact this a lot, but obviously, to your point, we have a lot of work ahead of us the moment, assuming that the FDA turns around here to get into the NCCN. The second step is the moment we have a price to influence the national guidelines in each country specifically. It's a bit of a mosaic to get that right in Europe.
Okay. No, that's very helpful. Thanks. Can I maybe follow up on the second point then, given what you were just saying? What, if anything, can you say on how you're thinking about pricing in Europe, say, relative to what we learned about the pricing last year in the U.S.? Yeah. How should we be thinking about the pricing?
We fundamentally have the same price philosophy as we had last year. We think that is appropriate. With that we mean that we have shown superiority over pomalidomide. We price at a slight premium to pomalidomide, but below the latest generation of drugs, below selinexor, belantamab and the CAR-Ts of course. If you think about that as a mental framework, you will find because we think that that is the appropriate pricing for us, which means that we are sort of less. We are priced below the other new entrants, but at a slight premium to pom. If you look at pom pricing in Germany, for example. Well, it's around depending on the exact month below, but around EUR 7,500-EUR 8,000 a month right now.
They had a higher, of course, starting price. That means mostly since when you have your free pricing period, you then have a mandatory rebate, et cetera, on top of that. Normally then you would try to aim for a price slightly above that price level. With the mandatory rebate after the free pricing period, you end up roughly where I just now stated. With that, you will be able to get that. You probably have a price around, you know, the EUR 10,000 mark per month initially through the free pricing period with a reduction. That's our aim, right? Our aim. This needs to be supported by the value dossier and as well as in the negotiation with German authorities.
Okay. No, great. Thank you very much, Jakob.
Thank you.
Our next question comes from Boris Peaker with Titan Partners. Please go ahead.
Thank you.
Great. Thanks for taking my questions. Maybe the first one, I just wanna follow up the discussion on the commercialization in Germany. If we just focus on Germany alone, is there a path to just being profitable in Germany? Or maybe let's just open it to kind of a wider question in general. If you get approved in Europe over the next few days, let's say, how much money would it take to get to some kind of a profitability or cash flow breakeven in Europe alone before we even consider kind of the cost of U.S. commercialization?
I'm gonna answer this by not answering certain aspects of your question because I'm not in a position to give appropriate guidance yet. I can tell you that assuming that you get the price level. If you look at the basket of myeloma drugs in Germany, for example, you find that the average price for myeloma products, with the exception of generic Revlimid now, a basket price is around EUR 8,000 a month, right, for the basket. At that price level, it is no problem to be profitable on a country level. It's not. It's a question, what is the optimal level of investment in terms of medical affairs function, et cetera, to support that. This is especially true in light of the lack of post-marketing requirements and post-marketing commitments for us.
It's absolutely a very profitable business to be in as a company, assuming that we can get the price that I just talked about. The exact right investment level to hit the sweet spot in terms of how much medical affairs resources do we want, do we want sales reps or not, where there are a lot of philosophies out there right now in Europe. As you know, sales reps can hardly get their foot through the door in multiple hospitals and institutions nowadays. You can think about this in various ways. We are running all these models. We have a fairly set view now that will be taken by the board how we wanna do this, of course. The profitability is not the question. The optimal investment level is a topic.
How elastic is that in terms of what can be achieved by adding additional resources, you know? I don't have the solid answer to that yet.
Got it. Maybe just quickly on the U.S. If you get a positive ODAC vote on the twenty-second of September, what's the kind of the timeline after that, do you think, in this scenario?
First of all, I think, as you know, the ODAC, I think, might be a little bit. I think you should look at the events following the ODAC, right? Like what happens after the ODAC. Sometimes an ODAC can be fairly hard to interpret, and sometimes a no becomes a yes, and sometimes a yes becomes a no. I would really look at the events following the ODAC. I think everyone wants to do chronology on the actual ODAC in itself, but ultimately it's the events that follow. Klaas, you could comment on that after I finish here. The second topic is how fast can it go? We have a few positives. We already have a J-code, but we're not in the NCCN guidelines, right?
We were taken out, so we need to return to that. I don't have a timeline for how fast that can happen. For many, it's important to be in the NCCN guidelines to actually be there. The J-code is alive and kicking, which normally takes a long time to get. That's a huge positive in terms of speed to market. When it comes to the actual commercialization, I would separate that into two topics. One is commercially available, which means that a physician can write the script, and we can deliver the product, and we can get paid for it. That is built on having sufficient pharmacovigilance infrastructure, medical information, as well as the financial backbone and the supply and drug supply apparatus in place. We deem that we can have the
We are already doing this, but of course, we took this decision early this summer. It is roughly a six-month period, which means we cannot straight after a positive opinion of an ODAC and an FDA decision actually charge money for the drug. We gonna make everything we can to make the drug available, but we will not be able to charge money on day one because simply the backbone will not be there since we broke it down. Then to the commercial buildup, we get reps, et cetera, in place. That will of course take several months, and I will need to return to that, the exact plans and the scale-up and the amount of investment we are willing to take, as well as potential partnering discussions in parallel run.
Klaas, maybe you would like to comment on the events following the ODAC or the ODAC itself there?
No, actually, I think you mentioned the most important piece, which is that the ODAC itself is just one piece.
In the chain of events that most of the time happen within the weeks after the ODAC, where the FDA takes a formal position that may or may not be aligned with the ODAC's views. I think that's the most important thing to consider when listening to the ODAC.
Just as a final note, Boris Peaker, we have remained in contact with HCPs, et cetera, and they are actually very interested in the product. I think my biggest headache, so to say, is to actually get the backbone so that we can have drug supply and charge money for the product and the NCCN guidelines. I think those are the two key components, and we cannot do the NCCN guideline part until the FDA has lifted, if they do that, the current situation, have resolved the current situation. When it comes to the supply piece and to be able to charge money, we're doing it right now at our own risk. That's important to be able to so that we can achieve that goal before the end of the year.
Great. Thank you very much for taking my questions.
Thank you.
The next question comes from Patrik Ling with DNB. Please go ahead.
Yes, hello, everyone. Could I just follow up on one of your previous questions? You, Jakob, you mentioned partnering discussions. Maybe you can elaborate a little bit on that given how much you talked about building an organization now, both in Europe and in Germany, how we should view a potential partnering for melflufen going forward.
I mean, given this weird situation we're in that we discussed before, we are both in the fortunate and unfortunate situation that we need to look at all these alternatives in parallel. We cannot just wait for one thing to materialize. The one thing we can control is to make sure that the drug gets available, can be prescribed, and we can charge money for it. We have to do that also for ethical reasons. In parallel with that, we are obviously looking at the partnership tracks and for part or whole of geographies, right? It's ultimately an NPV calculation for the board. What is, A, achieving the goal of making this product available for patients, and B, creating the most value for shareholders?
Obviously, it's hard to answer that question without getting appropriate term sheets on the table, but we are doing everything in parallel, and then the board can make the decision whether we should continue to do it alone or whether we should take a partnership offer that has been given to us. I can't give more guidance than that, but we are just doing this very rationally, in the best interest of patients and the company, so.
Okay, great. I also have a few questions to Annika regarding the financials. I mean, the reversal that we saw now, I mean, your comments seem to imply that there might be more reversals coming in coming quarters. Is that the case, or is this a one-time event?
We still have a reserve on the book or provision on the books. Yes, there could be more reversals coming. As we obviously reevaluate them each quarterly report, every month, actually. Yes, that could be the case. As per publishing the report, we still have the provisions that we think are relevant and prudent to have at this point.
Okay, great. Could I also ask about net working capital, how you think that will develop going forward? Because that had a quite significant impact this quarter.
Yes. As always, when you grow, there's considerable tied-up capital, even though it's, so to say, recoverable. Again, how that's gonna develop is going to depend quite a bit on the speed and what we decide to do where. I realize that's not really a number, or an answer that you can do numbers on, but that's the best I can do right now.
Okay, great. Last question. When it comes to R&D to support the pipeline, you mentioned OPD5 and your NK engager. Could you elaborate a little bit on how much you're willing to commit to the pipeline right now and how we should see your spending going forward?
I mean, I can't give you financial forecast for that. It's Jakob here. What I can say is that we are planning full steam ahead unless we hit some unexpected setback to actually since OPD5 preclinically is clearly a superior product to melflufen to run the phase I/ phase II trial that we hope to initiate next year, right? We are doing the plans to do that. The second is to make the NK cell engager platform ready for the clinic, and as previously discussed, to be able to enter the clinic early 2024, which means, of course, CMC and toxicology programs in 2023. We will come back to see if we can give more appropriate guidance on those.
It is important to note that the NK cell engager platform, given that it is a biologic, will require toxicology in primates. That is, of course, more expensive. You can look at analog companies to understand roughly what costs that entails.
Maybe I can just add some more color to your question as well, which is, I mean, as you realize, we're running an extremely tight ship right now. That way of running the company will continue. Even if we grow, we will do it with the smartest available resources that we can at the time.
Okay
Kind of effects and cost consciousness that you've seen throughout the strength.
Yeah.
Okay.
Just, Jakob, general comment to your. It's not only your question but other questions is, given the unusual situation we're in, we're right now scrambling to create the foundational strategy with what we have now. That will take us a few months to sort out between partnerships, what do we do alone, exactly, so that we can give appropriate strategic guidance for 2023. Once we have that, we can also quite easily start to give a, you know, a better view of what the cost base will be in 2023, right? This all happens as we speak. We of course, regardless whether we want it or not, we need to have landed on our feet in exactly what this plan looks like in the next 2 months-4 months. Basically during the autumn.
Great. Thank you very much, guys. I'll jump back into the queue.
Thank you, Patrik.
As a reminder, if you have a question, please press star then one to be joined in the queue. Our next question comes from Valentin Champagne with Kempen. Please go ahead.
Hi, good afternoon. Thank you for taking my questions. Perhaps I missed it, but what is the new cash runway guidance now after the recent capital increase? Secondly, could you provide some more color on the potential for a partnership in Europe? Any context you can give on ongoing discussions, what types of parties, and how far along are you would be appreciated. Thank you.
Thank you very much. On the first question, it kind of links to my recent commentary. If you just look at our current activity level and some sort of, to be a bit rough, sort of a tent, trying a kitchen and hot dog commercialization process in Europe, this money will easily last us way into 2024. The core question is really what exactly are we gonna do? Will we increase the spend on commercialization in Europe? How aggressive will we be in the clinical development program? Most importantly, what exactly will happen in the U.S.? Right now we have a very good cash runway, but obviously, to really answer your question, we need to internally answer those three questions I've just listed, and we are developing that plan right now.
This is just because of the funny way that this has played out now for us, that these questions cannot be answered until, you know, during this autumn. Hopefully towards the end of the year, we can give much more appropriate guidance. For now, we are very well capitalized. When it comes to your second question, can you repeat the second question again? Sorry.
Yeah, of course. Could you provide some more color on the potential partnership in Europe and maybe some context?
Yeah.
On the ongoing discussions, what type of parties and how far along are you in?
You know, basically we lifted the phone the moment that we had a positive CHMP opinion, and we have been very, very much at work during the summer. I think actually, it says more that some of the counterparts have been on vacation. We're in the middle of it. We're having multiple discussions right now, and I don't want to comment more on that than that.
All right.
Just to be clear, as a company, we have no interest to sign a dotted line regarding European rights until we know where we land in the U.S., since everyone will see whatever the FDA comes out with as something that impacts the peak sales potential in Europe. It would be really wrong from a shareholder value point of view to sign any agreement prior to we know the color of the FDA outcome.
Okay. Thank you very much for your answers.
Thank you.
This concludes our question and answer session. I would like to turn the conference back over to Jakob Lindberg for any closing remarks.
Thank you very much. I don't know, it's unusual to apologize. I just would like to apologize for the lack of clarity we can give to certain topics. I just hope that you as shareholders understand that the way that this has developed has created a situation where we are sort of. We are really putting the tarmac down as we use it, which means that some of these topics will not be answered until they will first be answered over the coming months. We will of course try to answer them as diligently as possible. I hope you can also take with you what an amount of positive development that we have had lately, and we hope to continue to have that over the next few months.
We think the data supports it, and we have continuously said that science leads the way, and we have science on our side. Hopefully this also materializes in regulatory actions and commercial potentials that reflect that. With that, thank you very much, and do not hesitate to contact us or through the investor relations function if you have any further questions. Thank you.