Thank you so much. Hello, everybody. This is Guido Oelke, CEO of Sobi. Welcome to our Q1 2023 conference call for investors and analysts. As usual, the presentation was posted to sobi.com earlier today. You know, basically as per usual as well on slide 2, please take note of the Safe Harbor Statement. Unless stated otherwise, we will be making comments that relate mostly to Q1 performance in 2023 at constant exchange rate and in million Swedish kronor. Let's turn to slide number three. This is the agenda, where we plan to cover all the key aspects of the report today. We are going to share with you presentations on Q1, followed by Q&A until around 3:00 P.M. Swedish time.
Please keep your questions short, and we will try to keep our answers also pretty much to the point. For those who on the phone, please join in the queue for questions by pressing star one. We propose you ask only one or two questions at a time. In speaking order, I'm joined by Henrik, our CFO, and Tony Hoos, our new Head of R&D MA, and Armin, our Senior Scientific Medical Officer, is also participating in the Q&A session. We have Anders also, Anders Öhman on the phone, the previous Head of RDMA. You know that he's at least going to be up for election to the board and hopefully will be elected at the general meeting of shareholders.
It just shows, you know, that we do this development in RDMA in a very systematic and organic way. Please turn to slide number four. Starting off, I'm pleased to say that Q1 2023 has been a good quarter for Sobi with continued solid growth. You know, revenues increased at 6% at actual rate, contracted at by 2% at constant exchange rate. The main reason is related to phasing of sales to our partner in China and the high comparison for Kineret due to previous COVID-related sales. If we exclude these two factors, the underlying revenues increased by 8% at constant currency, and that's quite gratifying. The launch medicines increased by 66%, driven by COVID. Very proud of our hemophilia business. It grew by 10%.
Aspaveli is surfacing to become material and had sales just below 100 million, SEK 95 million. Wide immunology was overall held back with the COVID comparison for Kineret. Gamifant continued a good continued the trend with increased numbers of patients to the tune of 32%. We are glad that more patients are now benefiting from Gamifant because, you know, as you will hear from Tony later, you know, there's a lot of need in the society also, beyond or outside of the U.S. EBITDA reached SEK 2.2 billion in the quarter with a margin of 40%. As much as we like our economic progress, we are very happy with the progress that we have made with the pipeline.
You know, we have much higher certainty for efanesoctocog alfa now based on the U.S. approval and the positive Phase III results for the children's study. This means, you know, that we are, you know, ready very soon to file. SEL-212 met the primary endpoint in the two Phase 3 studies, DISSOLVE I and DISSOLVE II. This is, you know, we are still expecting more detail. Tony will update you on this. We feel that the product based on the primary endpoint data looks pretty competitive with existing therapy, and it's confirmed by market research. Simplifying our economic rights in nirsevimab by the royalty agreement was also an important move for the company.
Gives us, you know, strategic option ability to use the funds for growing the company in different forms and shape and also simplifies our interaction with Sanofi moving forward whilst preserving our economic interests. Approvals for Empaveli and Doptelet in Japan speak to the quality of the RDMA team. We have completed the enrollment for the EMERALD study or Study 4 team that is relevant for the U.S. filing. More news obviously to come. With all that considered, we confirm our outlook for the full year 2023, with revenues anticipated to grow by low-to-mid single-digit and at constant currency and for adjusted EBITDA in the low 30s.
The outlook excludes Sobi's right to royalty on net sales of tocilizumab in the U.S. As usual, I mean, we were asked earlier in some calls, you know, it's basically our main basic principle that we look at life more in a more conservative and prudent way. I would like to take the opportunity to thank all my colleagues at Sobi for their contribution in the 1st quarter and in every day striving to bring life-saving medicines or relevant medicines to patients faster. Please turn to slide number 5. Moving to disease areas and geographies, the phasing of sales to our partner in China and COVID-related business have, you know, significantly distorted this picture and the comparability of numbers, you know.
Just, you know, as a reference, Doptelet did not decline but, you know, in outside of China it grew 78% and our business international business excluding these distorting business excluding factors grew by 54. It's... We want to, we wanted to be transparent, hence, you know, we have shown this, but, you know, we have a very strong underlying business course. Let's turn to slide 6. Turning to hemophilia, this was a very good quarter. This continued stability. Elocta grew at 9% driven by patient growth, consumption and geographic expansion. Alprolix increased by 16%, driven by patient growth and geographic expansion as well. Next slide 7.
As earlier mentioned, Doptelet grew 78% in markets out of China, driven by increased uptake of new patients in the U.S. and the ongoing launches in Europe, international markets. That's a very gratifying development. In Europe, we saw strong growth in Germany supported by recent reimbursement in Italy and Spain, so we feel that there's much bigger news to come. In the U.S., the trend continued with more new patients, new prescribers and higher share, and also longer duration of treatment. The market share gained at this juncture is mainly from the injectable competitors giving rise to believe that we could do more. The first quarter was also adversely impacted as already previously mentioned by the sales to our partner in China.
We are expecting ambulatory effect in Q2, future Doptelet beyond Q2 will be determined really by the U.S., Europe and other international markets due to the generic entry in China in 2023. Please turn to slide number 8. The launch of Aspaveli continued well with quarterly sales just below SEK 100 million. As previously said, we launched now in Germany, U.K., France, part of the Middle East, Australia, with some early sales in some other countries where reimbursement is starting to come in. These sales are really not reflective, of our entire territory. We are just a bit the beginning. Have around 140 patients at this juncture. Next slide. Slide that's number nine.
Turning to immunology, Kineret really declined only because of COVID-related sales and the rebasing will be flushed out in the next quarter and then you should see a growing business again. Gamifant increased by 5%. The growth was mainly driven due to increased number of patients which I quoted already and, you know, but shorter in the U.S., shorter treatment cycles. We are working on this and we feel that we are on a good way. The Study 6 of the Phase II study in secondary HLH was published. We'll talk more about this later. You know, our D share is actually... Its study demonstrated really favorable efficacy and safety and about EMERALD study I talked about. Also strategically the window for Gamifant is opening up. Please turn to slide number 10.
We are now moving to Synagis and Synagis was really in line with our expectations. There's a small variation which versus the last year, the first quarter. Please bear in mind that we had a very strong season in the in the end, at the end of last year. I think there's nothing to read into it. product has done very well and we're very gratified with the evolution. In April, as mentioned, we announced a new royalty agreement with Sanofi for nirsevimab, the termination of the participation agreement with AstraZeneca. This has highlighted this new structure that provides simplification gives only increased strategic flexibility. nirsevimab is under regulatory review in the U.S. and was recently approved in Europe. I will now hand over to Henrik for the financials. Please go ahead, Henrik.
Please turn to slide 11 I think.
Thank you, Guido. Hello everyone. I think it is slide 12. I'm pleased to take you through the key financials for the first quarter of 2023. Starting with the top line, Q1 was a good quarter with a solid business performance. Revenue of more than SEK 5.2 billion was the highest Q1 ever as reported in SEK, and the second highest quarter, benefiting from both underlying performance but also currency tailwinds. As we saw, the reported growth was 6% and corresponding to -2% at CER, explained really by the lack of sales of Doptelet to China in the quarter and last year's COVID-related sales of Kineret.
Looking at the bars to the left, in immunology, we see the impact in the quarter of the seasonal pattern of Synagis with high sales in Q1, however, lower sales in the previous quarter. Furthermore, a strong trend in hematology driven by the strong performance of Doptelet in the United States and Europe and the hemophilia products. If we go back to the table, the gross margin in the quarter of 80% is strong because of the seasonality with Synagis, but it's also increased from a year ago due to product mix, not at least the lower sales of Doptelet to China, which is a low-margin business, and the favorable FX impact.
The EBITDA margin was 40%, equal to the adjusted EBITDA margin for the same period in 2022, and there were no items affecting comparability in the quarter this year. The operating expenses, excluding amortization, came in slightly below the previous quarter, but increased versus Q1 2022 by 4% at CER, driven by increased R&D expenses, mainly related to SEL-212, where we had the readout in the quarter. Good cost control remains in focus for Sobi. Earnings per share for the quarter ended at SEK 3.60, just below the adjusted EPS from last year. The operating cash flow was strong in the quarter at close to SEK 2 billion, reflecting increased operating profit. As anticipated, in Q1, we had some important milestone payments.
Cash flow from investing activities was SEK -3.2 billion and included milestones related to nirsevimab of $175 million, a sales milestone for Doptelet of $65 million, and the EU approval milestone for Zynlonta of $50 million. As a consequence, net debt in the quarter ended at SEK 8.7 billion, and this corresponds to a net debt to EBITDA ratio of about 1.25. For details on the items affecting comparability that we had in Q1 2022, please see page 4 in the Q1 report. Please go to slide 13. We turn to the financial outlook for the full year 2023, which is as before, on revenue growth at constant exchange rates and the adjusted EBITDA margin.
We will continue to expand our presence in hematology, immunology, and specialty care through our ongoing launches and new medicines and geographic markets, and we anticipate sustained sales growth. We confirm the previous outlook for 2023, which reads as follows. Revenue is anticipated to grow by low- to mid-single-digit percentage at CER. We continue to invest in launches and advance our pipeline of new medicines and emphasize the long-term value of the business. Therefore, we anticipate an adjusted EBITDA margin at the low 30s % of revenue. As before, this outlook excludes any element of, from nirsevimab. With the new agreement in place, this means that it excludes Sobi's right to royalty on net sales of nirsevimab in the U.S. With this covered, I will now hand over to Tony for the pipeline. Thank you.
Henrik, thank you very much. I'm Tony Hoos. If you allow me a personal word, this is day 17 of my journey with Sobi, and I personally really look forward to making a contribution to Sobi's success. Another word of introduction, Anders Öhman, who is on the call today, my predecessor, and I have made a real effort to ensure that this transition occurs seamless, that we have no gaps and nothing is lost, which I think is really in the best interest of everyone, last but not least, our patients. In addition to Armin, we also have Anders here to take any questions you may have that may be better addressed by him. That being said, allow me to walk you through the continued progress of the pipeline that we can share and the news flow in the first quarter. Thank you.
You already turned to slide number 15. Let me walk you through. If we start with hemophilia, Guido highlighted two events already. I think this has been really, really nice for us with the two events, as you see here highlighted once more, the regulatory approval in the U.S. and the positive XTEND-Kids Phase III pediatric study. If we think about the FDA approval, the label is routine prophylaxis, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding. Really good and meaningful label for the product, and again, primarily based on the data of the XTEND-1 Phase III study, where the once-weekly dosing met the primary endpoint, which I personally believe is a significant improvement for patients to protect bleedings for people who suffer from severe hemophilia A.
Then the second light in haemophilia, as you can see here. The XTEND-Kids Phase 3 pediatric study did meet its primary endpoint. I think this is very exciting. Just to recap, we had safety, efficacy, and pharmacokinetics of efanesoctocog alfa as a once-weekly prophylaxis in these previously treated kids, and they were all under 12 years. Personally, I was quite interested in seeing that we had no factor VIII inhibitors observed in the 74 children who enrolled in the study. Thereof, we had 65 who experienced at least 50 exposure days. Again, I would say this is a very, very good result, and Guido hinted at that already. These two trials combined, of course, will form a basis for a future European submission.
Since I just mentioned Europe, you may recall that we were granted the orphan drug designation by the European Commission already in June 2019. Maybe I continue now to Kineret. Kineret, our IL-1 receptor antagonist. During the quarter, the third regulatory submission was made for Kineret in China, this time for the potential use in the treatment of cryopyrin-associated periodic syndromes or CAPS. We would expect a regulatory decision in 2024. Just as a recap, we had two other China submissions, FMF and Still's disease. Probably going back to what Guido mentioned already, you will recall SEL-212, that's the pegloticase ImmTOR for chronic refractory gout. In March, Sobi and Selecta announced positive top-line results of the Phase III DISSOLVE programs.
Those were two placebo-controlled, randomized clinical studies, of course, to determine safety and efficacy of 2 different dose levels in adult patients with CRG. The primary endpoint of the program was met. The primary endpoint was serum urate control during month 6. Now having the top-line data, it's extremely important that we very diligently analyze everything that we have, including secondary endpoints, get the full dataset and a full study report as soon as possible. We'll also now check very carefully what additional evidence, including CMC, we'll need to include in a future license application with the regulators. Perhaps the next point to tackle is Doptelet, our thrombopoietin receptor agonist for chronic liver disease. It did receive regulatory approval by the PMDA in Japan on March 27, 2023.
That combined with the approval of Empaveli Aspaveli on the very same date in Japan, I think is a very powerful story for patients in Japan. You can look at all the details, obviously, in the respective pieces of information. But I would say just looking at geography, look at what happened in the U.S. regulatory submission, China, two approvals in Japan, I'm very, very happy with that, I should say. There is another piece of information I'd want to share with you on pegcetacoplan. Some of you may remember that pegcetacoplan had or has a study in ALS. We have an update regarding this open-label long-term extension portion of the Phase II MERIDIAN study that has been led by Apellis. All of these studies or usually these studies have independent data monitoring committees.
They did an unblinded review of the available data. They didn't find any safety concerns, but the IDMC concluded that the available data did not support continuation of the treatment. In consequence, as you will have seen in the press release, the decision has been made to discontinue treatment with systemic pegcetacoplan related to this open-label long-term extension study. Just as an FYI, all patients had completed the randomized treatment portion of that study, and of course, all data will be reviewed as planned. Maybe this allows us now to go into the outlook. If you go to the next slide. We talked already about hemophilia, efanesoctocog alfa. We of course now the regulatory submission in the European Union. We'll do everything we can to be as quick as possible.
The scheduled date is second half of 2023, as we've shown on this slide. Again, if you go to China, you will see two events for China. You will see Doptelet, and you will see Kineret. We expect a regulatory decision for Doptelet in ITP and Kineret in FMF, i.e., familial Mediterranean fever. Moving on to Gamifant. For Gamifant, we expect to receive data from the EMERALD Phase 3 study. This is what we call the Still's disease cohort. We aim regulatory submission for the Still's disease cohort in the second half of 2023. Perhaps I offer two additional bits of information for Gamifant. One, you will have seen Guido refer to that already, the results of Study 6.
This is a Phase II study in patients with macrophage activation syndrome secondary to Still's disease. That was published in the Annals of the Rheumatic Diseases. I personally think this has been very meaningful data. In addition to that, I always have a pretty good signal about how high the medical need is when we receive urgent calls from physicians and requests for compassionate use, and we get quite a lot for this drug. We see there's a real unmet medical need. Again, we're super happy to help in this regard wherever we can. Perhaps this allows us to move on. Just one word about nirsevimab in the U.S., it's progressing with a regulatory review, with a decision anticipated at the end of the third quarter.
You know, AstraZeneca and Sanofi here play a role, and Sobi has the right to royalties on Sanofi's future net sales of nirsevimab in the United States. That concludes my outlook for the second half of 2023. You will see some anticipated milestones for 2024 on the right-hand side of this slide. My suggestion would be, we will keep this without commenting further at this stage. These are certainly our targets, and we will update you with refined goals, targets, timelines as we progress through 2024. Maybe before I close this session and hand it back to Guido, if you allow me again to say a personal word. I really want to say a heartfelt thank you, first of all, to all my colleagues at Sobi for the hard work they do.
I also want to express an appreciation for our external experts and in particular to all our patients and their families who participate in our trials, because without what they are doing, we would never be able to help advance the science and really care for those who we strive to help. Thank you very much, and let me turn it back to Guido. Guido?
Sorry, I was on mute. Sorry. Thanks, Tony. Let's go straight to slide number 18. You know, just to quickly summarize, this was a good, very solid quarter. You know, as you have seen, you know, there's a lot of reasons to believe that we have a pretty exciting future ahead of us with all the progress we made on pipeline, on restructuring agreements, and also on approvals and study readouts. The business is in a good shape. You know, as you have seen, you know, that we are bullish about the, you know, the prospects of this business.
As Tony said, well, you know, thanks everyone at Sobi who made this possible, we hope to continue provide good news for patients all this year and as we move forward with our business. We now go to Q&A, slide 19. For those on the phone, please remember to press star one and ask the question. Can I please remind you that limit your questions, and we will also try to be sharp on the regarding the answer. Let's go right into the first question.
We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the touch-tone telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to use only handsets and eventually turn off the volume from the webcast. Anyone who has a question may press star and one at this time. Our first question comes from the line of Yun Yang from Jefferies. Please go ahead.
Thank you. I have a couple of questions. The first one is on nirsevimab. Guido, you mentioned that, you know, the recently, simplified arrangement, royalty arrangement with Sanofi, that could increase your strategic, flexibility. Can you comment on what kind of strategic options that you are considering? The second question is on Doptelet. there were no sales to China, this quarter. Are you expecting sales to China in second quarter beyond? Thank you.
Yeah. Thank you. Basically, let's start with the easy question. You know, on Doptelet, we're expecting a material order in, you know, in the near term, and that should bring us back on track. You know, looking forward, I think beyond this, it's, you know, we have to see that, you know, the landscape with generic entries in China is changing. Our revenue expectations are going to be, you know, rather moderate.
When you look at our existing business, you know, just for, you know, that was north of SEK 140 million last year, growing at 78% right now, you can understand why we believe that this business has a very good future, even if basically, you know, in the second half, maybe there's not so much business or nothing in the most extreme case. Yeah. We don't know at this stage. You know, so this will be a growing business irregardless. We always said that, you know, this business has to grow, you know, even if you're notwithstanding what your aspiration for China is. We're on a good way because, you know, now we are launching in Europe. We got the approval in Japan. I mean, so there is going to be a...
With longer patent protection, there's going to be a certain dynamic. Regarding nirsevimab, that is pretty straightforward. I mean, yes, we like nirsevimab because it props up our earnings. Royalties mean, you know, that you record earnings at 100%, so that's useful for your ratios and basically helps us to fund the projects that are of priority to us, that we take ownership. That's option number one. Option number two, is if we really would have no other way of funding, obviously you could monetize this royalty stream now because it's pretty transparent. You know, we need to just find somebody who likes the prospect of nirsevimab, and there are obviously many forecasts on. Both options are relevant at this stage. Nothing, you know, nothing has to be decided.
In the meantime, we love the earnings and look forward to a successful launch of Sanofi and good books and nice proceeds, and we avoid this uncertainty around investing into what we would be for us non-core. It, it avoids, you know, this agreement avoids an investment also moving into the future in areas that are not core to our business. Maybe. Hope that this answers it. Yep. Maybe we go to the next question.
The next question comes from the line of Charlie Mabbutt with Morgan Stanley. Please go ahead.
Hi. Thanks for taking my questions. I'm Charlie Mabbutt from Morgan Stanley. Firstly, I'd say the growth of two hemophilia products was a decent step up year on year. At the start of the year, you suggested stability for the franchise in 2023, but is this rather conservative? Secondly, on Zynlonta, given this was the first sales quarter, could you please talk a little bit about the physician feedback and the cadence of uptake you expect over the year? Thanks very much.
Yeah. Thank you. You know, Let's say this regard to hemophilia, you know, we always like to hold our horses, obviously. You know, the growth was driven by a strong, you know, patient growth, internationalization, and also, let's say the internationalization. That there we still have a little bit of more room. We don't underestimate competitors, you know. That's the reason why we always take a conservative stand, you know, and there will be some price effects also kicking in. You know, indeed the franchise is in a good way. Yeah. There's no question. Yeah. I mean, it's 9%, respectively 16%. Can't complain too much. You know, it's too early now to change our view.
I mean, we are excited about efanesoctocog alfa and with a bit of luck we already have some one or the other Middle Eastern country launching during the course of this year and then definitely Europe in the following. I think that will be the engine that will give us reason to have a lot of optimism. With regard to Zynlonta, it's a bit early. I mean, we have 3 patients now, and they're very recent. I would refrain from now in Saudi Arabia, now giving you feedback. From what I hear, the therapy has worked well, to be honest, now to draw, to extrapolate from there, I think would be premature.
I think we are When we have the next market, you know, next market will be German launch, and then, you know, the rollout across Europe, I think then, you know, I would like to come back and give you a more profound perspective. You know, it's nice to launch it, you know, and nice to make it available because there was a high demand, and we are convinced that this product can play a role. You know, this, we don't need a lot of effort to it, because we are already in the target audience. Thank you.
Thanks.
The next question comes from the line of Christopher Uhde with SEB. Please go ahead.
Hi there. Hope you can hear me. My question, first is on Elocta and Alprolix, again. You mentioned phasing. Do you expect the phasing to unwind in Q2 or later this year? Would you please quantify the impact it had on Q1? Then also if you could give us any more detail on the price cuts, where and roughly how much? Thanks. Oh, the second question I'd like to ask is, so the 2-year period of investment has sort of, that you guided to, two years ago, has of course come to an end.
Perhaps you could give us some more color on the expenses for R&D going forward for, you know, over the next few years, for the existing product and pipeline portfolio. Thanks.
Yeah, sure. Sure. You know, with regard to Elocta and Alprolix, you know, I mean, we have never really come out but, you know, we would have expected a SEK couple of 100 million of impact, yeah, out of these price adjustments and cost containment measures, including clawbacks in Europe. Because we had a little bit of, you know, we have still room to improve consumption per capita, and we have a strong momentum from international. We figured that, you know, we should be able to have a stable, at least, hemophilia business, whatever that means. You know, it could be also slight growth. We start well. We like it. You know, that's already, you know... Anything else is a bonus. You know, we are relentless. We will not give in here.
But, you know, order of magnitude, you know, they have a couple of 100 million SEK headroom. You know, you've seen, you know, they are applicable already now, so, you know. As in the momentum we had from the consumption and the nationalization outweighed that impact, which is nice. It will come in, and we will have to keep going. The hope is that we are still a little bit low in the tank and that we can keep this moderately growing. Our guideline was always stable. Stable growth or stability. We don't change this at this juncture because we want to understand.
You know, we see that the issue is also that the more you have losers in this game, who have nothing to offer but, you know, price potentially, you know, that could also have effects in the one or the other market. I mean, on a materiality basis, this has not yet it provided additional pressure. You know, we know that there are, you know, that this is, this is coming. The more we are looking forward to the efanesoctocog alfa launch, where we are able to step out of this with a better product, at least to a large degree.
With regard to the investment, I mean, you know, I hope that we can defend a strong R&D spend the way we have it by further significantly growing our business, so that basically from a-- you see some leverage coming in over the years. When you look at it, I mean, you know, this is, you know, we have now nice endpoints in our RDMA, which clearly gives new visibility now to a, to a future beyond also 2025 and, gives them reasons to believe that we strongly grow the business. We are not yet at this juncture in a, in a phase where we will optimize because we still have a couple of things to do.
We hope that, you know, that the spiraling effect that we have seen, that basically over the next years will come down. It will also depend on which opportunities, you know, we will be able to source in. I think, you know, as a mix, this is a good business and, you know, I like where we are today. It's a much more, much better strategic position than we have been 1 year ago or 2 years ago. There is a nicely balanced portfolio with access to the earnings at least of 3 main assets. I mean, that is in a part fantastic. Yeah. I don't give you now because typically we don't give guidance beyond one year.
You know, for the end of the year, so we would not. You know, I see the point. I understand, you know, we have obviously given you guidance on 25 by 25. I've got to copy this. Haunts me nearly every call. We have given guidance on the delivery. I mean, when you look at it, you know, we have invested obviously in substantially broadening the company. You know, you had China many times, Japan, Australia. All of those companies were not around some time ago. I think, you know, it's, we are acting in the best interest of shareholders.
Okay. Thank you very much.
Thank you. Next, next question maybe?
The next question comes from the line of Alistair Campbell with RBC. Please go ahead.
Oh, yeah. Good morning. Thanks very much for taking the questions. I've got two, please. First of all, just, I wanted to talk a bit more, if you can, about Beyfortus, about nirsevimab. Just in terms of that new agreement with Sanofi, I'm sort of keen to understand how that negotiation originated. Was that something that you sought to do? Ultimately, is the outcome of that value neutral or have you had to give up some value to sort of gain more flexibility in that deal? The other point of that is just basically Sanofi this morning is still saying that, you know, that they remain optimistic they'll be able to get to the U.S. market with Beyfortus to participate in the RSV season before the end of the year.
I mean, technically, if they did get sales before the end of the year, in terms of the timing of when you receive royalties, could that fall into this year, or is that more likely to fall into next year? Thanks.
Yeah. I mean, firstly, you know, with nirsevimab, I mean, when you dabbed with, obviously two very large companies as you know, you need to wait for the right moment. We basically, we knew that we could be a piece of the puzzle that these other two companies were trying to address.
Oh, fine.
We did not really champion this because otherwise this would have impaired our the economic outcome of the negotiation. Yeah.
Mm-hmm.
You know, that basically was the reason, was our strategy all along. As you can see, you know, very positive because clearly very neutral to your other question and because we also saved milestones and, you know, and simplified the agreement and obviously are now not forced to invest into a product that we don't control or manage. Forward-looking, there are obviously opportunities for this product, and we basically participate in a very meaningful way in the economics of this product without taking any risk and without having lengthy discussions and negotiations every quarter on how much on how to define profit or revenues or other things. I-- we like that. It's simple and clearly keeps us harmless, but it gives us also, as I mentioned earlier, an asset that has a currency.
With regard to RSV, you know, I cannot speak obviously on behalf of Sanofi. They know this better. We have in a previous call, we did an outside-in where we, I think the last one where we also asked, you know, people close to the subject matter in the committees and everything, you know, ask a consulting firm. At that, you know, so I can report on both assumptions. I think the there's a high probability that they will have sales.
In that case, depending on how they will record them, you know, I think there's a good chance that we have already material earnings this year because, you know, the way this works is that normally, when a proficient company in this space or when you look at analogs launches, you can, even in 2 months, can achieve a significant market penetration, and you just need one shot, and you have accomplished the sales for that patient. I-- we are cautiously optimistic to see something. You know, you have to really ask Sanofi how they view this because we can only extrapolate from what they have said, and we are not in charge.
Great. Thank you.
Yes. You're welcome. Thank you.
The next question comes from the line of Peter Östling with Berenberg. Please go ahead.
Thank you.
Yes. Thank you. Can you hear me all right?
Yes.
Yes. Just a question on Doptelet in China. How should we look at this? Is it prudent to take away all sales beyond Q2 this year, even in for 2024 and beyond that?
Yeah. I mean, you know, it's prudent for sure, yeah. It cannot be less than zero, yeah. You're very prudent. We hope that, you know, in the further discussions that the brand that we own carries some weight and we are now rethinking also how to look at this, how to restructure this partnership with Sanofi so that maybe we can preserve something. You know, in terms of materiality, it's not gonna be to what we have seen obviously last year by any respect. That's the reason, you know, why we need to grow what we have. You know, we have some really explosive growth right now in Europe, even though we don't have all markets there. We're continuously going strong.
I look forward to the launches also in Japan and Australia, then taking the product into Latin America and in the big markets. I think, you know, that we will, you know... We are absolutely optimistic that this is a growing product for us, despite the fact that it is conceivable that we flush out the China business as of 2024.
Okay. just to confirm, did you say that you expect a material order in Q2 and then more or less nothing?
Yeah. I mean, you know, I'm always cautious because, you know, we are dependent here on the ordering of our partner. You know, we're expecting at least one big order, yeah.
Okay. Okay.
That should, yeah. Absolutely.
Okay. Thank you.
You're welcome.
The next question comes from the line of Viktor Sundberg with Nordea. Please go ahead.
Mm-hmm.
Yes. I hope you can hear me well.
Yes.
Yeah, I had a question on nirsevimab, but that was partly answered. I can go ahead with another question on nirsevimab. The payments here to AstraZeneca and Sanofi, will they be booked in the P&L or in any other way? That was my first question.
No. They are milestone payments. They are not P&L related.
Okay. Perfect. On Doptelet, I mean, if you strip out the China sales historically, and look at the growth here, it looks like quarter-on-quarter that it's quite flat, you know, 4.6% quarter-on-quarter growth since Q4. Are there any, like, gross to net dynamics that we should be aware of or do you have any comment on that? Maybe also, if you can comment on the growth in Europe versus the U.S. here as well.
Yeah. No, I think what we see is really, I mean, exponential growth in Europe because, you know, we broaden the base. The product responds extremely well to promotional effort. We are coming in at the right time. In the U.S., you know, I mean, this is always, you know, you basically when you go through this really exponential growth, you always hit at certain points of time, you know, certain milestones where you think, "Okay, am I still collecting enough new patients?" That has absolutely, you know, when you look at the trend, it's very powerful and also at the latest indicators of new patients, new prescribers. This is, you know, we are by far not done. Yeah. It's. You know, there is.
I would not worry too much about now the comparisons the way you've done them there, Christopher. The, you know, the 78% is quite indicative of what we are, you know, where the product is right now. In terms of acceleration also and all of these other parameters, the leading indicators, they're pointing all into the right direction. Sometimes, you know, there's also some inventory left and right, you know, which we don't obviously encourage in any whatever form or shape. When it impacts a little bit when you do the corporate quarterly comparison, but when you look at the leading indicators, they are all very solid.
Okay. Thank you.
You're welcome.
As a reminder, if you wish to register for a question, please press star and one on your telephone. Star followed by one. The next question is a follow-up from Mr. Uhde with SEB. Please go ahead.
Yeah, sure. Thanks very much for taking my follow-up. I guess in terms of SG&A and the number of employees at the end of last year was unchanged from the year before. SG&A excluding amortization was up 25% and salaries were as well. What factors are behind that? How much was related to the restructuring and how much to other reasons, you know, but why we're exceeding core inflation? What should we expect in terms of inflationary impact on overhead in 2023? What were the 56 new hires in the quarter for? Thanks.
Yeah. Henrik, you wanna take it?
Yeah. To start, to be clear, if we look at SG&A in Q1 compared to Q1 last year, excluding amortization at constant currencies, it is virtually flat.
No. I was looking at the full year, from last year, from the annual report.
Oh, yeah. Okay. It's Your question relates to 2022 compared to 2021?
Mm.
Yeah.
I'm trying to use that to get a sense of the trajectory going forward, what, you know.
Yeah.
What factors are involved. Yeah.
Well, when it comes to the increase in 2022 over 2021, it's really about the launches of Aspaveli and Doptelet worldwide and also our internationalization. When it comes to where we go from here during the rest of the year, we expect some increase in SG&A compared to Q1 because of the same reasons. We continue to try to accelerate both Doptelet worldwide and Aspaveli in our territories. That will lead to a slight increase from the Q1 level in the coming quarters.
In terms of number of FTEs, similarly, the gentleman here next to me, Tony, he is planning to have some increase in staff and similarly in SG&A. That's really balanced increase across the board.
Okay. Inflationary impact?
For the rest of this year. Sorry,
Inflationary impact.
Well, we think we can handle inflation fairly well. Like everybody else, we've tried to curb salary increases. We also focus quite a lot on procurement, where we try to, through an improved procurement, actually, mitigate or offset some of the inflationary pressures.
Okay. Thank you very much.
Thank you.
Today's last question comes from the line-
Next question.
Sorry. Today's last question comes from the line of Peter Östling with Pareto Securities. It's a follow-up. Please go ahead.
Yes. It's not a question, just another confirmation. When it comes to price reductions within your hemophilia business, did you say that you had already seen some or that you expect some for the rest of the year?
We have seen some. I mean, the effect, because they have been executed and we are expecting also, let's say, well, you know, more to come because of not they are less because of government, but more because of further competitive pressure. But, you know, we think that we can, the way we look at it, that we can, we can compensate this in a way that we have seen, you know, also in the first quarter, maybe not to the full extent. I mean, this was a very nice, obviously evolution here. But, you know, that's how we look at it, yeah. Okay. Thank you, Billy. Yes. Yes, you know it. You're welcome, Peter. Okay. I think, you know, we can have probably more questions if you and answers, you know.
I guess we have tomorrow a call as well. You know, and if you have questions, please refer to us. I mean, this was just a first, you know, meeting in private. You know, as you, as you can see, you know, we are pretty quite happy with where we are today. Would I like to present to you an order for Doptelet or since Q1? Absolutely wasn't the case. You know, what I like is that our underlying business grows very strongly and that we're doing the right things on our pipeline. On this note, I wish you a great week and look forward to hearing from you.
If there are any questions, please refer to our, as per usual, funders, you know, and, you know, from a, from a summary, I mean, you know, just a short detail, you know. We think, you know, that, you know, our perspectives on 2023 is unchanged, but this is more probably also driven by the fact that, you know, this Q1, it's... Well, why would we go ahead of ourselves at this juncture? This is a good business and strong earnings, strong growth as a product. Yes, some headwinds, but as you can see, we manage. All right. On this note, I wish everybody a good day. Thank you.