Swedish Orphan Biovitrum AB (publ) (STO:SOBI)
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Earnings Call: Q3 2019
Oct 31, 2019
Ladies and gentlemen, welcome to the SOVI presentation of our Q3 results. I'll now hand the call over to Guido Upper, CEO and Henrik Steenqvist, CFO. Please go ahead.
Yes. Thank you so much, and welcome, everybody. Really a pleasure to familiarize you with our Q3 results. You've seen this. And I think without further discussion, let's go straight into the meat.
Forward looking statement, please take note of this. And with this, I go straight to Slide number 4. And when you look at the results, I think we are quite satisfied by the fact 27% top line growth, 18% EBITDA growth, very pleased with the performance of Elocta and Alprolix. And for those who have seen some news, we shall lock on Eloctate and very gratified by the performance, the 30% for the quarter and over 40% for growth products, zinc to date and very strong patient growth. And when you look at the Gamifant, we are literally €6,000,000 to €7,000,000 You just have to see this in view of this is an ultra rare disease.
We had a couple of patients that we involved. And there were some inventory movements, as explained. But overall, we actually were very happy with our year to date performance for Gamifant. And we are considering the label that we have. And obviously our main focus is on broadening the label.
Very strong performance with Synagis and also the Kinered, particularly after the very strong Q2. And at the same time, we were able to prepare our future. Dover is a very important acquisition for us because it takes us into the broader rearm of hematology. And we have been able to opt in early for PIP-one, which demonstrates our commitment to the area in hemophilia, but also it's a signal that we are very excited about the results, and we think that we have this is productive future in our hand. And we have completed, obviously, the acquisition of MR Palomar related assets.
I'm very happy to have over 100 people now in Switzerland that basically allow us to take us to the next level. So when you basically go straight into the next slide, what you can see here is and I think that may not we have maybe not yet done the best possible job to explain this, but we have now a very nice portfolio of actually pre- and on market assets. And when you think it through what we now have created with DOPTELET in the different indications, CIT, ITP, CLD and with Gamifant in the different indications, indication expansion with FINRAID with 8897 and SVIF-1 primarily, we will have a very nice cadence of launches of key indications in the key geographies over the next 5 years. So you would expect, in an average year, to have around 3 main indications to be launched in either Europe, U. S.
Or Rest of World. And that gives you, let's say, a sense that the company is obviously extremely well positioned for future growth. And so maybe we go into the details now of this presentation. It's reasonably straightforward. We'll go through Elocta performance.
As you can see here, strong quarter on quarter growth. And the good news is that we have very strong patient growth on an incremental basis quarter on quarter. And that is not fully reflected. As obviously, you have seen the Q2 summer period is always a bit of a tough one, But it's nice to stop on a high. And growth is coming from the key EU 5 markets.
Actually, we have also nice growth in the U. K. And we have now reimbursement in 27 countries. And this shows the key. Our world is still very positive, and we keep growing this product at the right rate.
When we go then to our Alprolix, there, let's say, the sales quarter on quarter is a little bit more mixed. And basically, what you can see here is that we have 34% growth versus previous year. And also for Alprolix, very strong patient growth, even though not as many patients are initiated on a quarter to quarter basis. So frankly, I mean, let's say, the Q2 could have been a little bit too good. But overall, the trending is actually very positive and strong underlying growth.
And when you then come to the fundamentals of our hemophilia business, We think that we have we continue having a very strong momentum. We can further gain patient share by launches in new markets, Central Eastern Europe, Middle East, but also still significant growth opportunities for us in many European markets. We think that the individualized therapy, given the very low AVRs that you can achieve with this, And that also enables patients to live the life, have an active life as opposed to adjust their life to the profile of the product that this is resonating. Our liberate life campaign has gained significant traction in many markets. And we don't get the sense that we are losing, I would say, the aspirational spot versus new therapies.
There's obviously a new there's obviously a demand. But we think that we have a credible alternative, and we don't think that there's going to be one size fits all because there will be people with different needs. And we think that we're addressing the needs of a large group. And then we and then I think when you look also realistically at the data, and I think this is many times forgotten, The Factor replacement therapy is here to stay because when you look at the data of some of the latest introduction in the non factor space, they actually cannot show the results without additional factor consumption. So it is also, let's say, and by definition, if eat the kind of activity level that you need, you cannot achieve as new therapies.
If you want to have an active life, there is actually no alternative. And we think that with the Fc fusion, we have the best factor replacement therapy more stable. Coming now to the broader rearm of hematology, when you think it through, we're very happy with our existing products and the way they're doing. We think that we with a very strong focus on individualization and protection with the data we have and we are now in the process to further generate, we have a very strong alternative for patients in our stable. We have now acquired Doctor.
Let comes into the market environment. Well, not yet acquired. We have an intent to consume the deal within the next few weeks, and it looks very positive in this regard. So we are entering into a market with $2,000,000,000 with an underlying growth rate of 5%. And let's say and we can we believe that we're coming with a better product, highly efficacious, no food interaction and not associated with liver toxicity and oral.
So we think that there's going to be a significant opportunity for us in this regard. And on top, we were going to be the 1st, as it looks right now, TPO that will be indicated in the CIT indication, which is very material given the number of patients, 70,000 patients concerned overall in the U. S. So if you get a couple of those, that will make a material difference to our revenue forecast, we'll start second half sorry, Q2 next year. And then we have F-one.
And when you look at these data in a once a week environment, and you have in the 65 microgram dose per milligram dose, you have an activity level of leaking percent after a week. We think that we have the future in our hands, and this is this cannot be matched by current available treatments. And so you have an unprecedented level of protection with, let's say, there's a promise of very low side effects. And so the trade off decision that you have to take here is very favorable. So overall, a very nice franchise.
And we made great strides to complement this portfolio in Q3. So coming to the acquisition pieces, I think we have reported on this. Here you can see this is more per usual. We have 3 indications, as I talked about it. We have the tender offer out there, and we expect to finalize the it's on the 8th November end of business.
So mid of November, this deal is going to be going to come into play. And as I outlined, I'm very excited about this transaction because it also comes with a team of over 120 people. And with this key. We get also an R and D setup in United States, which we think is very important for us because you need to be close to the key opinion leaders and thinkers in the largest rare disease market of the world. And that will really bring us closer, and we were excited about the quality of work that has been performed at Dova.
Coming to immunology, I think we are gratified. I mean, the backbone business, FINARET, is still plowing along with scummy front. We're entering, obviously, a space with high unmet medical need. But overall, when I look at it on a year to date basis, I think this is a very positive performance, and we'll talk a little bit more about it. And obviously, we are now preparing synergies for the RSV season and have positive indicators there.
So coming to the next slide. Here, you can see the overall uptake. I just want to remind everybody, let's say, that the key season for Synagis, as you know, is in Q1 and Q4. So the in Q2 and Q3, you have officially preparing, let's say, for the next season. And therefore, the shape of the curve looks a bit counterintuitive even though we have made substantial progress.
Kineret, obviously, as I mentioned, doing extremely strong. And let's say, and Synagis, we obviously now really laser sharp focused on the new season, and we have very strong signals. The RSV season is making its way now from the south. We have a very strong update uptick data from Puerto Rico. And we can see that the number of referrals is actually at a very encouraging level.
So very positive about Synagis. And maybe we can then talk a little bit about Dummy Fund. And when you think about Gummy Fund Q3, the $67,000,000 the sales pattern for this for these ultra rare diseases is obviously volatile. I mean, we looked at many different launches that have happened over the last 10 years in this overall rare disease space. And very few are able to achieve a straight line and so are we.
And basically, I think what you just have to recognize is our current label includes, give and take, 100 patients. And as we explained, there are around 1700 to 1800 patients in the United States. So if you have a couple of patients that are weaned off, then you have and plus inventory, let's say, movement, you have, by definition, a little bit more of a lumpy, let's say, sales uptake in the earlier at the earlier stage. And for me, key is not now to get excited around this, but to be clear about the North Star. The North Star in United States, the enabling 1800 patients who have access to this medicine.
And that's really what is at the really at our foremost idea base is debate. Is actually a primary and a secondary or is it one HLH and how many of those patients really have a genetic signature. And we are very keen to drive this debate. And in the meantime, we have various encouraging signals, interim results on secondary age of age in children, MAS, and this looks very promising. We have shared interim data with the FDA, and we intend to do this shortly again.
And we have initiated now the we are in the program process now to initiate the secondary study in adults during the course of this quarter. So actually, the main focus is really enabling the larger patient population. That's really the mark up in my books of success. And we just have to accept that there's a bit of lumpiness in the scales. But all the indicators that we have tell us that we are able to penetrate more hospitals, we are able to make the product.
We gain momentum within the primary HOH community further. So it looks for me, it looks very positive. But the materiality of the sales we kick in once we have unlocked the secondary indication, and this will make a significant difference also to our economic results. So coming to the financial results, I would like to refer to Henrik before we then round it off.
Thank you, Guido, and good morning, everyone. So let's look at the financial summary of the quarter. Revenues, as we saw, amounted to $2,930,000,000 that corresponded to an increase of 27% and 22% in constant currencies. The year on year growth was driven both by our product sales of Elocta and Alkermes and, of course, the new products in immunology. Elocta sales for the quarter was impacted by positive revenue adjustment of €35,000,000 related to French pharmaceutical taxes.
We had the same kind of adjustment in France in Q3 'eighteen, but then it was $52,000,000 positive for Elocta. In terms of organic growth, that is adjusting for synergies, this was 17% for the quarter. Gross margin for the quarter was 74% and year to date is 76%. The slightly lower gross margin for this quarter compared to previous quarter was due to the seasonal product mix effect coming from lower sales of synergies and also lower sales of Gametant and lower royalty revenues. And as a natural consequence of the RSV season and corresponding expected higher sales from synergies, we expect gross margin in Q4 to increase compared to Q3.
EBITDA increased by 18% and reached CHF1.99 billion for the quarter corresponding to a margin of 38%. In a similar way as in Q2, the seasonality of Synagis revenue impacted the EBITDA margin negatively in Q3. On the other hand, operating expenses for the quarter were a bit lower due to the lower activity level during the summer period. And for clarity, we have not yet booked any expenses to the restructuring provision from Q2 as this is expected to start gradually in Q4. The Q3 EPS number was 1.84%, a decline of 20% for the quarter, mainly impacted by the increase in amortizations following the investments in intangibles and the high number of shares.
Furthermore, the operating cash flow of €995,000,000 for the quarter and the €2658,000,000 year to date is signaling continuous from operating cash flows. So as a result of that, net debt amounted to $7,600,000,000 at the end of the quarter as we completed the acquisition of enapalumab and related assets amounting to ZAR4.9 billion and that asset priority review voucher for consideration of just above DKK900 1,000,000. Dollars The next slide shows the development of operating cash flow per quarter and our cash conversion over EBITDA calculated on a latest 12 month basis. We see a continued very strong cash conversion, close to 70% on EBITDA. Net debt of SEK 7,600,000,000 at the end of the quarter corresponds to pro form a leverage of less than 1.5x.
The contemplated acquisition of Dovahtrolleys, of course, which will be debt financed, is expected to increase this leverage in Q4. But with a continued strong operating cash flow, we will be able to deleverage quickly. And as a reminder, operating cash flow and the cash conversion will have a seasonal pattern because of the strong seasonality of the synergies, meaning a slightly lower cash conversion in Q4. And with that, I hand back to Nido. Thank you.
Yes. Thank you, Henrik. And we're going to round it off with our financial outlook. Basically, we see the results in Q3 as very encouraging. We are very upbeat about it.
When you think about the quarter to quarter effect, you take away some of the considerations for a lot of the organic growth would be even higher. And this happened with the strong momentum we have on patient acquisition. So we feel good. We prepare the future. The dummy front looks very promising.
There's a bit of lumpiness, but the opportunity is so large. And a good way to enable the broad pool of patients. And now Doctor. Let gives us a fantastic opportunity to broaden hemophilia into the realm of hematology, which we think is very exciting. And feel very much confirmed by what we have started and expect strong revenues for the year.
Don't see at this juncture any reason to deviate from our forecast for this year in top line, but also not in bottom line. But as you can see from the Q3 results, we are in a good way. And I think this is I think it's reasonably straightforward. Mainly, this is the time now to open the discussion and be ready for questions as they may arise.
Your first question comes from the line of Raveen Shamit from Deutsche Bank.
Bank. Firstly, just on DOPTOLAT in chemotherapy induced indication. So that looks like it will probably be the major differentiator for the product if the trial is successful.
But I
was just wondering if you could kind of walk us through the Phase 3 trial design and what the challenges are in that setting given that physicians currently manage thrombocytopenia by reducing dose of chemotherapy. Is that something you can control in the clinical trials? And then second, just a question on Elocta. So you've seen Henley kind of made broad reimbursement wins in the U. K.
And Ireland. And I was wondering if you could discuss what you're seeing in those regions and what your expectations are going forward? And then just on elotrigan, were there any true ups in the hemophilia royalty there? Because it doesn't seem that that's consistent with the sales trend.
Yes. With regard to DOPTELET now in CIT, I think if you could bear with us because we currently have not consummated the transaction. And I think it would be appropriate for us to come back to your questions. We can provide to the extent possible in a more volatile discussion some further color definitely in the Q4 earnings. We would go in great lengths into this.
But at this stage, we have not consummated it either. So it would feel a little bit inappropriate now to go into this. But the I mean, obviously, we think we share your excitement around CIT, and we think we're optimistic that GCIT indication can be enabled during Q2 next year. So it's I mean, we have a readout whether we have a positive readout in the study. But I think it would go too far now at this stage, and I'm just mindful of the current state of the transaction.
The other thing is with regard to U. K. And Ireland. I think the headline is impressive, obviously. Reality may vary, yes?
So I think our understanding of the tender situation varies a little bit bit from the impression that has been generated. We think that there is going to be an opportunity for a new tender in the U. K. Mid of next year. And there where basically everybody will then be invited to participate.
So I don't think you can I would think that this already constitutes progress as such? And we and frankly, we have not lost any patients on a net basis in the UK or Ireland. And in Ireland, let's say, we have made an announcement or we'll make an announcement on the current status of the tender. And yes, I mean, I think you have to recognize that currently, we have we are in the market there. So yes, there will be patients who will want to benefit from alternative treatment.
Our ambition is going to be to make sure that patients understand the trade off. And then we'll see what the impact of those 2 initiatives will be in reality. So I would have there, Richard, a more nuanced view. But I agree that the headlines when you basically just focus on this unreflected looks impressive. But the reality, we think, may vary.
And we will make an effort, to be honest, to make sure that the reality is different. With regard to the royalties, yes, I think you have 2 effects. And I think we need to hold our horses, obviously, for the presentation of Sanofi later during the day, where you will get a good view from them on what the business is. But you have also different effects. You have and we commented on this that we are very optimistic, at least, about Sanofi's ability to drive the business globally given their phenomenal footprint.
Okay. And the next question is from Christopher Hughey from SEB. Please go ahead. Your line is open. Yes.
Just to start by asking you, you got cut off on the last comment you said about optimistic about their ability to drive sales in rest of the world. But then Yes.
You got cut off. I just realized, it's a little bit lonely. Yes, so basically, just coming back, basically you look at Sanofi, I mean this probably one of the most strongest engines in emerging markets and has a very broad international footprint overall. So you will see, I guess, and this is at least our hope, You will see compensatory effects in the royalty development. And but I don't want to comment on this much more because I think it's the Sanofi's privilege to comment on their performance later this afternoon.
Okay. Should we go back to the previous questioner or should I stay on?
Yes. Yes, please.
So if you repeat that one.
If you repeat the other question, maybe we will cut off from the other question, let's say, there.
Yes. So I guess in terms of Gamifant, can you comment on the proportion of adults there? And I
mean, is
pricing a factor in the results or pricing changes?
Not in Q3. And we had there are some the primary adult patients, let's say, obviously, and we had less of those in Q3, and some of them were weaned off or moved on. And that basically affected because they are heavier patients that affected our results in Q3. And it is and then plus, it's never perfect. It's some patients come in and we had a couple of more patients coming in, in September, but then you don't have them for the full course.
And therefore, you have a bit of lumpiness. I hope that this is basically overall washing out in the next couple of months this effect.
And then when it comes to hemophilia, so Alkrelix is down a bit as you pointed out and it's a little bit like what we saw before last year. And then similarly, if you exclude the one off for Elocta, it's slightly down sequentially.
Is this
the same kind of thing as we saw with Alprolix last year in Q3? And is there anything else going on? And can you comment on the sales impact of HEMLIBRA in Germany at this point?
Yes.
So either in the quarter and then
Maybe I'll give you a reference point. So the effect when you compare it at least Q3 2019 versus Q3 2018, actually, our growth in 'nineteen without those special effects would have been even larger, yes, let's say than what we have shown in our results because the effect and basically the clawback of the let's say that basically has happened here is just this would have been part of our sales during the course of the year anyway. We are not having here an extraordinary benefit. It is just that we realized this during the quarter. And but I think the marker of progress, because you have a lower activity level, first of all, probably there have been been some adjustments of inventory between Q2 and Q3.
Very difficult to get a good grip on this because these are decisions definitely you're not in use of the hospitals. But what we see is a very strong progress in the patient acquisition or the netting off. And we haven't seen on a net basis material impact of FEMLIBRA. In fact, we have seen in Germany very substantially is one of our strongest growth markets.
Okay, great. And so that's the same then for Alprolix?
Anything for Alprolix. And then Alprolix, we obviously we have a head on head competition with GSL. And let's say, in there, it is just overall growth is very material still. You look at the year to date growth very strong. Yes, there has been an adjustment on the there's no adjustment, sorry.
There is a the relative growth rate in Q3 is lower than year to date, but this is partially seasonally driven. And you would also, over time, obviously, see that the relative growth rates cannot be at the historical level because we have significant market shares now in the meantime of paying a number of markets. And it will take us some time also to unlock again new opportunities. We are not on the schedule, for instance, in Spain. And we are rolling out the product now.
So now in Central Eastern Europe, where it's not material and in the Middle East. So there is there will be still significant growth, let's say, and we see very strong patient acquisition. There's nothing wrong, to be honest, with the quarter on quarter comparison is not reflective of the progress we are making as a product, of the demand growth of the product.
Right, great. And then for Cenad, just should we see this early stock buildup as potentially weakening the sales performance in Q4? I mean, if they already have it now, they don't need to buy as much later.
I would say it's more as an offsetting effect for the reduction of inventory after the last season. And then basically, you would have to build up. I'm very optimistic for the Q4 performance of Synagis because all the indicators tell us like referral rate, very strong, even double digit increase. We have, let's say, we know from the last season, we had a 2.5% organic growth rate. We see that which we reported, all the indicators that we have now tell us it's better.
We'll need to still convert. Nothing beats money in the bank. But what we can see in terms of indicators from the because we said there were certain leakage points that we wanted to address. And let's say, like improving number of cycles, giving improving the number of overall referrals and scripts. Just to take advantage of the current labor, we also think there's a case to be made to expand the labor.
So Synergis world still looks good.
Great. And then so last two questions are, I guess, so on R and D or is the last question really. So should we be expecting any more restructuring costs during the year? And is there any other I mean, what other explanations are there for the low I mean, it's relatively low after making the adjustment.
No, I think the R and D expenses will increase during Q4 because we had quite a number of studies that we are, let's say, that we are now commencing like secondary, for instance, HLA and adult. So you should see the Q2 expense line more like this summer period, but now a lot of things are ramping up. So we are not going to slow down in R and D. Henrik, do you want to comment on the restructuring?
Yes. We don't expect any further restructuring expenses. And we have not yet charged any expenses to the reserve that we made in Q2. But that will come gradually from Q4 and onwards.
And next question is from Victoria English from Tavernall. Please go ahead. Your line is now open.
Yes. Good morning. Thank you for taking my call. I'm calling to ask I'm curious about your comments on replacement factory replacement therapy and whether you see any scope within your development strategy for investigating gene therapy. I'm mentioning that because there are a number of other companies that are looking into gene therapy.
And I'm just wondering what your thoughts are.
Yes. No, absolutely. I mean, basically, when we look at the means, we have at Sobeys the size of the company and the overall risk reward decisions that we have to take within those logistics business in this regard. We think that we are extremely well positioned with 8,001 because very high probability of success, very favorable profile versus existing therapy, even versus new therapies. Essentially, the promise of normalizing the patients for 4 days out of 7.
And then you say, yes, well, would you now need more you need to diversify to the gene therapy? Then you have the question mark around hepatotoxicity. With gene therapy, you have the question mark whether the effect size can be sustained. And then you have the question for us, is this other vectors of today already the vectors of tomorrow? And there is is a debate and I'm not professing that we have now the ultimate wisdom of this.
I think what we are currently doing is more looking at it from a perspective that we say, we feel quite good with what we have with Alprolix every other week. We have very encouraging data points from Ireland where very significant trough levels can be obtained after 1 or 2 weeks of dosing, we have GLP-one knocking at the door, creating a lot of excitement in the key opinion leaders with the medical community and also I think it's maybe a little bit underappreciated potential. We believe in this product and gave opted in early. So I don't think it's coming immediately, but we will obviously we are not ignorant to the fact. We think that this is something we want to look at on a continuous basis.
But I think the gene therapy piece is also the question is going to be how impactful is it going to be particularly in our territory, it will be Europe, what is going to be the pricing and, let's say, and the funding of this. So we are not totally to be honest, we are at this stage a little bit more reluctant to jump on the vent wing. I know it's very fashionable. And that is very much and the promise of cure is obviously phenomenal. But when you look at the profile of VIF-1, you are pretty close to normalization.
So we think that at this stage, maybe not, but we will continuously review the area. And when we feel that risk reward decision is looking differently, we probably will think about something. But for now, we are covered. But it doesn't mean that we are against gene therapy. I mean, that's we see that I mean, we are not oblivious to this, yes.
Thanks very much.
You're welcome.
And next question is from Victor Sundberg from ABG Colliers. And Victor from ABG Sundal Collier. Please go ahead. Your line is open. Okay.
We'll just go to the next question. It is from Yingying from Jefferies. Please go ahead. Your line is now open. I have a couple of questions on genifent.
Number 1, first, what do you think you need in your secondary hives indication on the label? Have you spoken with the regulators in terms of requirements for approval? And second question is, as you're moving into secondary HLH Appalachian with tissue macerulizers in the primary form, We saw currently there is some off label use. So how are you addressing the pricing point, which could be more accessible for secondary population? Thank you.
Thank you, Eun. So first of all, we have had, as I mentioned, interaction. And I will refer to actually, we have Milan here as well, and he will talk you through in a few seconds. So we had already interactions with the regulator. And let's say, they indicated to us that they what they would like to see and we'll work on this.
And obviously, with regard to the price, we have made a step in this regard, let's say, in the higher dose to enable, let's say, patients. But the thing is, we don't because of the label, we cannot obviously encourage usage there. What we do is, we will focus totally on broadening the indication by the clinical trials. That's really our main focus. Maybe Mila, you want to talk about those indications?
Yes. So, hi, Johan. This is Mila. So, as we discussed earlier, we reported some early data in patients with Sawyer that developed secondary MAS. And we continue to feel that these data are very,
very encouraging.
We have a dialogue with the FDA around this data set, and we plan to meet with the FDA again once we have data from at least 10 evaluable patients. So once we have an agreement with the agency around what the requirements are, then we will update you on how that looks. And as Steve already mentioned, we plan to initiate the drug study of the patients' secondary hilumase in adults later this year. And once we start accruing data, then we will also meet with regulators to better understand the requirements.
Can I ask you a follow-up question? So in the Q1, as any from sales, I mean, there is some negative impact from inventory shift, but do you see some negative impact from pricing perspective on secondary form?
No, I think actually, the heavier patients that we had were actually primary HLH patients. And let's say, there were a group of 3 patients that got off the drug. And no, we haven't seen this. I think also for us, that's the reason why we said, sales are obviously important. We are a profit organization.
It's clear. But our primary focus is now enabling the secondary indication. And we have encouraging signals, as Milan just pointed out, for children now. And we will promote the debate because ACE is on a given suspicion that ACE is a genetic signature with secondary HLH patients as well. And we will engage into this debate and will set up various centers of excellence now in United States and work there is hand in hand with the key opinion leaders because we understand that there's a significant demand and how we can do the best for patients here.
And the next question is from Victor Svanbergen from ABG Sundance Collier. Please go ahead, Victor. Your line is now open.
Yes. Hi. Thank you for taking my question. I just wondered first if you could comment in which market you compete right now with Hemlibra in Europe. Of course, they're reimbursed with the UK and then Germany, but I wondered if any other markets if you're competing in other markets in Europe?
And secondly, the Dola acquisition, would that be consolidated into your numbers
for the
Q1 in 2020, if that is materialized? And my final question was if you can give any more details on the strong development of Cineref, maybe some details what drove the strong deal to the quarter and what is your expectations for the future? Thank you.
You're welcome. We have I mean, HEMLIBRA, as such, is available now in Europe basically nearly everywhere because it is and they got approved in the non inhibitor education some time ago. And they got sorry, in the inhibitor indication some time ago in the non inhibitor indication, obviously, earlier during the year. And they are basically now going through the pricing approval processes, And they are visible, obviously, now in a number of markets. And we but we haven't seen the effect yet on our business, let's say, in terms of patient acquisition.
So it will take some time. We'll see when I think the good news is in 9 months from now, we will have a good perspective here on what the impact is and then we don't probably need to speculate too much. And let's say, with regard now to Kineret, I think there it is we have changed the focus, commercial focus in the U. S. And changed leadership there.
This is very beneficial because it brings it down now to down further. Obviously, as we reported, there's a huge increase of scientific interest in the product and represented by the significant number of applications that are coming out on IL-one inhibition every year. That stimulates clearly the product. And then it's Europe, the Stills indication. And we have a number of ideas how to expand the product further.
The product is very current. Then sorry, there was a third element to your question. Can you repeat this? Yes.
It was about the timing for consolidation of course.
Yes, the consolidation, yes. Yes.
Well, we are now in the process between signing and closing. And what we've communicated is that we are expecting this transaction to close by mid November, and that would mean that we would consolidate it by mid November. That's just our expectation. Yes.
Thank you very much.
Already didn't go to Q4, but definitely Q1. If it closes.
Okay. And just And there will be no further questions. So I'll hand the call back to the speakers. Please go ahead.
Yes. Thank you so much for
your interest and very much appreciated the questions and hope that we could, let's say, make this reasonably interesting for you. But just to sum it up, very confident about the performance of the company today and very happy that we were able to prepare the future for the group. And there's something to do with you know, but this is what the team is up for. Appreciate it. I wish everybody a great day.
And this now concludes the conference call. Thank you all for attending and you may now disconnect your lines.