Swedish Orphan Biovitrum AB (publ) (BIOVF) Q1 2023 Earnings Call Transcript

Swedish Orphan Biovitrum AB (publ) (OTCPK:BIOVF) Q1 2023 Earnings Conference Call April 27, 2023 8:00 AM ET

Company Participants

Guido Oelkers - Chief Executive Officer

Henrik Stenqvist - Chief Financial Officer

Tony Hoos - Head of RDMA, Chief Medical Officer

Armin Reininger - Senior Scientific and Medical Officer

Conference Call Participants

Eun Yang - Jefferies

Christopher Uhde - SEB

Alistair Campbell - RBC

Peter Östling - Pareto Securities

Viktor Sundberg - Nordea

Guido Oelkers

Hello, everybody. This is Guido Oelkers, CEO of Sobi. Welcome to our first quarter 2023 conference call for investors and analysts. As usual, the presentation was posted to sobi.com earlier today, and basically, as per usual, as well on slide two; please take note of the Safe Harbor statement. And unless stated otherwise, we will be making comments that relate mostly to first quarter performance in 2023 at constant exchange rate, and in million Swedish krona.

Let's turn to slide three, and 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 a Q&A, end at around 3:00 PM Swedish time. And please keep your questions short, and we will try to keep our answers also pretty much to the point. [Operator Instructions] We propose you ask only one or two questions at a time.

In speaking order, I am joined by Henrik, our CFO; and Tony Hoos, our new Head of RDMA; and Armin, our Senior Scientific and Medical Officer is also participating in the Q&A session; and we have also Anders Ullman on the phone, the previous Head of R&D and MA, and you know that he is at least going to be up for election to the Board, and hopefully he will be elected to general meeting of shareholders, and it just shows that we do this development in R&D MA in a very systematic and organic way.

So, please turn to slide four. And starting off, I am pleased to say that Q1 2023 has been a good quarter for Sobi, with continued solid growth. And also revenues increased at 6%, at actual rate contracted at by 2% at constant exchange rate. And 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 good to say.

The launch medicines increased 66% driven by COVID, very proud again of our haemophilia business, it grew by 10%, and Aspaveli is surfacing to become material, and had sales just below SEK 100 million, SEK 95 million, and while immunology was overall held back with the COVID comparison for Kineret. Gamifant continued the trend with increased numbers of patient to the tune of 32%, and we are glad that more patients are now benefiting from Gamifant because, as you will hear from Tony later, there's a lot of need in the society also beyond what's outside of the U.S. EBITDA reached SEK 2.2 billion in the quarter with a margin of 40%.

And as much as we like our economic progress, we are very happy with the progress that we have made with the pipeline. And we have much higher certainty for efanesoctocog alfa now based on the U.S. approval and the positive phase 3 results for the children's study. And this means that we are ready very soon to file SEL-212, met the primary endpoint in the two phase 3 studies, and [indiscernible] and expecting more details, and Tony will update you on this. But we feel that the product based on the primary endpoint data looks pretty competitive versus existing therapy.

And this is confirmed by market research, simplifying our economic [indiscernible] nirsevimab by the royalty agreement was also an important move for the company, gives us strategic [optionability] (ph) 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. And we have completed the enrollment for the EMERALD study or study 14 that is relevant for the U.S. filing, so more news, obviously, to come.

But with all that considered, we confirm our outlook and 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 nirsevimab in the U.S. And as usual, and we were asked earlier in some calls, it's basically our main basic principle that we look at life 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 first quarter, and in every day striving to bring life-saving medicines or relevant medicines to patients faster.

Please turn to slide five, moving to disease areas and geographies, the phasing of sales to our partner in China and COVID-related business has significantly distorted this picture and the comparability of numbers. Just as a reference, Doptelet declined but in outside of Chine it grew 78%, and our international business excluding these extraordinary factors grew by 54%. But we wanted to be transparent, and hence we have shown this but we have a very strong underlying business growth.

Let's turn to slide six, turning to haemophilia, this was a very good quarter, this continued stability in 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 seven, as earlier mentioned, Doptelet grew 78% in markets out of China, driven mainly by increased uptake of new patients in the U.S. and the ongoing launches in Europe and international markets, and it's a very gratifying development. In Europe, we saw strong growth, in Germany supported by [indiscernible], Italy and Spain, so we feel it as 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. So, 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 adversely impacted, as already previously mentioned, by the sales through our partner in China we are expecting complementary effect in Q1, but 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 eight. 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. So, these sales are really not reflective of our entire territory, really just -- it's a beginning, have around 140 patients at this juncture.

Next slide nine, so 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. And Gamifant increased by 5%. The growth was mainly driven due to an increased number of patients, which I quoted already, 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 2 study in secondary HLH was published, and we'll talk more about this later in the audition, as its study demonstrated really favorable efficacy and safety. And about EMERALD study, I talked about. So, also strategically, the window for Gamifant is opening up.

Please turn to slide 10; we are now moving to Synagis. And Synagis was really in line with our expectations. There is a small variation versus the last year, the first quarter. But please bear in mind that we had a very strong season at the end of last year. So, I think there is nothing to read into it. Product has done very well, and we are 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 new structure that provides simplification, and so we 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 update.

Henrik Stenqvist

Thank you, Guido, and hello everyone. And I think it is slide 12, yes. So, 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 ever, so, benefiting from both underlying performance, but also currency tailwinds. And as we saw, the reported the growth was 6%, and corresponding to minus 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 haemophilia products. If we go back to the table, the growth margin in the quarter of 80% is strong because of the seasonality with Synagis, but it's also increased from the year ago due to the product mix, not at least the lower sales of Doptelet to China, which is a low-margin business, and a 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 '22 by 4% at CER, driven by increased R&D expenses mainly related to SEL-212 where we had the readout in the quarter. And a good cost control remains in focus for Sobi. And 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.

And as anticipated in Q1, we had some important milestone payments. And cash flow from investing activities was minus SEK 3.2 billion, and included milestones related to nirsevimab of $175 million, the sales milestone for Doptelet on $65 million and the EU approval milestone for Zynlonta of $50 million. And as a consequence, net debt in the quarter ended at SEK 8.7 billion, and this corresponds to net debt to EBITDA ratio of about 1.25. And for details on the items affecting comparability that we had in Q1 '22, please see page four in the Q1 report.

So, please go to slide 13, and we turn to the financial outlook for the full-year '23 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. And we confirm the previous outlook for 2023, which reads as follows. So, revenue is anticipated by grow by low-to-mid single-digit percentage at CER. And we continue to invest in launches and advance our pipeline of new medicines, and emphasize the long-term value of the business. And therefore we anticipate an adjusted EBITDA margin at a low 30s percentage of revenue.

And as before, this outlook excludes any element from nirsevimab, and 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.

And with this covered, I will now hand over to Tony for the pipeline. Thank you.

Tony Hoos

Henrik, thank you very much. So, 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. And another word of introduction, Anders Ullman, who is on the call today, my predecessor, and I have made a real effort to ensure that this transition occur seamless, like 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. And in addition to Armin, we also have Anders here to take any questions you may have that may be better addressed by him.

So, 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. And thank you if you already turned to slide 15. So, let me walk you through. If we start with haemophilia, 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 kids trial, the XTEND-Kids phase 3 pediatric study. If we think about the FDA approval, [indiscernible] prophylaxis on-demand treatment and control of bleeding episodes, and perioperative management of bleeding, so, really good and meaningful labels for the product, and again primarily based on the data of the XTEND-1 phase 3 study where the once-weekly dosing at the primary endpoint, which I personally believe is a significant improvement for patients to protect bleeding for people who suffer from severe haemophilia A.

And then the second line is 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.

And personally, I was quite interested in seeing that we had no factor VIII inhibitors observed in the 74 children who enrolled in the study. And thereof, we had 65 who experienced at least 50 exposure days. So 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. And since I just mentioned Europe, you may recall that we were granted the orphan drug designation by the European Commission already, in June 2019.

So maybe I continue not to Kineret. Kineret, our IL-1 receptor antagonist, during the quarter the third regulatory submission was made for Kineret in China, and this time for the potential use in the treatment of cryopyrin-associated periodic syndromes, or CAPS, we would expect a regulatory decision in 2024. And just as a recap, we had two other China submissions, FMF and Still's disease. Probably going back to Guido mentioned already, you will recall SEL-212, [pegylated uricase] (ph) ImmTOR for chronic refractory gout. In March, Sobi and Selecta announced positive top line results of the Phase 2 DISSOLVE programs.

Those were two placebo-controlled randomized clinical studies, of course, to determine safety and efficacy of two 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 six. And of course 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. And of course 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.

So, perhaps the next point to tackle is Doptelet, our e 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. And 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 in China, two approvals in Japan, I'm very, very happy with that I should say.

And there is another piece of information I'd want to share with you on pegcetacoplan. Some of you may remember that pegcetacoplan has a study in ALS. We have an updated regarding this open-label long-term extension portion of the phase 2 MERIDIAN study that has been led by Apellis. All of these studies -- or usually these studies have independent data monitoring committees. They did an un-blinded 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.

And so, 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 FIA, all patients had completed the randomized treatment portion of that study. And, of course, all data will be reviewed as planned.

So maybe this allows us now to go into the outlook. So, if we go to the next slide. We talked already about haemophilia, 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 data is second-half of 2023, as we've shown on this slide. Again, if we go to China, you will see two events for China. You will see Doptelet and you will see Kineret, and we expect a regulatory decision for Doptelet in ITP and Kineret in FMF, i.e., familial Mediterranean fever.

So moving on to Gamifant, for Gamifant, we expect to receive data from the EMERALD phase 3 study, this is we call the Still's disease cohort, and we aim regulatory submission for this Still's disease cohort in the second-half of 2023. And 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 2 study in patients with macrophage activation syndrome secondary to Still's disease, and that was published in the Annals of Rheumatic Diseases. Again, 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. So, we see that a real unmet medical need. And again, we are super happy to help in this regard wherever we can. So, 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 a right to royalties on Sanofi's future net sales of nirsevimab in the United States.

So, that concludes my outlook for the second-half of 2023. You will see some anticipated milestone 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. And 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 trails 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.

So, thank you very much. And let me turn it back to Guido.

Guido Oelkers

Thanks, Tony. Let's go straight to slide 18. And just to quickly summarize. This was a good, very solid quarter. And as you have seen, there is a lot of reasons to believe that we have a pretty exciting future ahead of us with all the progress we made on pipeline and restructuring agreements and also on approvals and study readouts. So, the business is in a good shape. As you have seen that we are bullish about the prospects of this business. And as Tony said well, thanks everybody at Sobi who made this possible. And we hope to continue to provide good news for patients all this year, and as we move forward with, let's say, our business.

So, we now go to Q&A. Slide 19. [Operator Instructions] And I also remind you that limit your questions, and we will also try to be sharp regarding the answer. So, let's go right into the first question.

Question-and-Answer Session

Operator

Our first question comes from the line of Eun Yang from Jefferies. Please go ahead.

Eun Yang

Thank you. I have a couple of questions. The first one is on the nirsevimab. So, Guido, you mentioned that the recently simplified royalty arrangement with Sanofi, there could be increased U.S. strategic flexibility. So, can you comment on what kind of strategic options that you are considering? And the second question is on Doptelet. So, there were no sales to China this quarter. Are you expecting sales to China second beyond? Thank you.

Guido Oelkers

Yes, thank you. Basically, we have start with the business, and this is easy question. So, on Doptelet, we're expecting a material order in the near-term. And that should bring us back on track. But looking forward, I think, beyond this, we have to see that the landscape in generic entries in China is changing. So, our revenue expectations are going to be rather moderate. And when you look at our existing business, and just for -- 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 in the second-half maybe there is not too much business or nothing in the most extreme case here; we don't know at this stage.

But, so this will be a growing business in regards that we said that this business has to grow, even if notwithstanding what your aspiration for China is any other which way because now we are launching in Europe, we got [the approval trend] (ph). So, there is going to be -- there's longer patent protections there is going to be a certain dynamic.

Regarding on nirsevimab and it's pretty straightforward. I mean, we like nirsevimab because it props up our earnings, royalties, meaning that you record earnings in 100%, so that's useful for your ratios, and basically helps us to fund the projects that are a priority to us where we take ownership. So, that's option number one. And 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 need just to find somebody who likes the prospect of nirsevimab, and there are obviously many forecast on.

So, both options are relevant at this stage. Nothing has been decided. In the meantime we love the earnings, and look forward to a successful launch of Sanofi and [indiscernible] [nice proceed and via royalties] (ph) uncertainty around investing into what would be for us non-core, so it voids -- this agreement [indiscernible] investments. Also moving into the future in areas that are not core to our business, meaning hope that this answers, and we may be go to the next question.

Operator

The next question comes from the line of [indiscernible] with Morgan Stanley. Please go ahead.

Unidentified Analyst

Hi, thanks for taking my questions, [indiscernible] from Morgan Stanley. So, firstly I would say the growth for two haemophilia products was a decent step-up year-on-year. So, at the start of the year you suggested stability for the franchise in 2023, but is this rather conservative? And secondly, on the Zynlonta, given this is 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.

Guido Oelkers

Yes, thank you. Let's say, in this regard to haemophilia, we always like to hold our horses, obviously. The growth was driven by strong patient growth, international engagement, and also, let's say, the international basin. So, there we still have a little bit of more room. We don't underestimate competitors [indiscernible] always take a conservative stand, and there would be some price effect also kicking in. But indeed the franchise is on a good way. Yes, so there's no question here. I mean this was 9% was effectively 16%, can't complain too much. But it's too early now to change our view. I mean we are excited about obviously efanesoctocog alfa, and with a bit of luck we maybe already have [indiscernible] Middle Eastern country launch through the course of this year, and then definitely Europe in the following. So, I think that will be the engine that will give us good reading to have a lot of optimism.

With regard to Zynlonta, it's a bit early. I mean, we have three patients now, and they are very [wheezy] (ph). So, I would refrain from now in Saudi Arabia they are now giving you feedback. From what I hear, the therapy has worked well, but to be honest like how to draw extrapolate from there I think would be premature. I think when we have seen the next markets, next market will be German launch, and then the rollout across Europe, I think I would like to come back and then give you a more profound perspective. But it's nice to launch it and nice to make it available because there was a high demand and we are convinced that this product can play a role. And this -- you don't need a lot of effort, right, because we are already in the target ordered. Thank you.

Unidentified Analyst

Thanks.

Operator

The next question comes from the line of Christopher Uhde with SEB. Please go ahead.

Christopher Uhde

Hi there. Hope you can hear me. My question first is on Elocta and Alprolix again. So, you mentioned phasing. So, do you expect the phasing to unwind in Q2 or later this year? And would you please quantify the impact it had on Q1? And then also, if you could give us any more detail on the price cuts, where and roughly how much? And the second question I'd like to ask is, so the two-year period of investment that you guided to two years ago has, of course, come to an end. And perhaps you could give us some more color on the expenses for R&D going forward for the next two years for the existing product and pipeline portfolio? Thanks.

Guido Oelkers

Yes, sure. So, with regard to Elocta and Alprolix, they are -- and maybe I've never really come out, like we would have expected a couple of SEK 100 million of impact, yes, out of these price adjustment and cost containment measures, including global actually, in Europe. But because we had a little bit of -- there is still room to improve consumption per capita, and we have a strong momentum from international, we figured that we should be able to have a stable, at least, haemophilia business, whatever that means. There could be also a slight growth. We start well, we like it, but that's already -- anything else is a bonus. And we are relentless; we will not give any [indiscernible].

But order of magnitude, they have a couple of SEK 100 million headwind, but you've seen that they are applicable already now. So, having the momentum we had from the consumption [indiscernible] outweigh that impact, which is nice. But that we come in and we will have to keep going. But the hope is that we have still a little bit long to take and that we can keep this moderately going, but our guideline was always stable -- has stable growth or stability, and we don't change this. It is [indiscernible] because we want to understand this is a -- the issue is also that the more you have losers in this game who have nothing to offer but price, potentially, that could also have effects in the one or the other market.

I mean on a materiality basis this has not provided additional pressure. But we know that there are relevant [indiscernible]. 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.

And with regard to the investment, I mean I hope that we can defend a strong R&D spend where we haven't by further significantly growing our business so that basically from a -- you see some leverage coming in over the years. But when you look at it, I mean this is -- we have now nice endpoints in R&DMA which clearly gives you visibility to a future beyond also '25, and gives reasons to believe that we are strongly growing the business. So we are not yet, at least at the juncture, in a phase where we would optimize because we still have a couple of things to do. But we hope that the spiraling effect that we have seen, that that basically, over the next years, will come down.

But it will also depend on which opportunities we will be able to source in. But I think as a mixed use of the business and -- I like where we are today, so much more -- much better strategic position than we have been a year ago or two years ago, [indiscernible] nicely balanced on four-year with access, through the earnings at least, of three main assets that is in the pipeline is fantastic. Yes, so I don't have -- I don't give you now because typically we don't give guidance beyond one year. But I think -- and this is the year, so we would not particular -- I see the point, I understand. We have obviously given you guidance on '25. By '25 I've forgotten this that haunts me and nearly every call. And we have given guidance on [indiscernible]. I mean we have also, when you look at it -- we have invested, obviously, in substantially broadening the company. And you heard China many times, Japan, Australia, all of those companies were not around some time ago. So, I think it's -- we are acting in the best interest of shareholders.

Christopher Uhde

Okay, thank you very much.

Guido Oelkers

Thank you. Next question maybe?

Operator

The next question comes from the line of Alistair Campbell from RBC. Please go ahead.

Alistair Campbell

Yes, good morning. Thanks very much for taking the questions. I've got two, please. First of all, wanted to talk a bit more, if you can, about [indiscernible] nirsevimab, just in terms of that new agreement with Sanofi, I'm keen to understand how that negotiation originated? Is that something that you sought to do? And ultimately, is the outcome of that value neutral or have you had to give up some value to gain more flexibility in that deal? Then the other point of that is just basically Sanofi, this morning, is still saying that they remain optimistic of able to get to the U.S. market-based orders to participate in the RSV seasons 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.

Guido Oelkers

Yes, so firstly, with nirsevimab, I mean when you dance with obviously two very large companies as Sobi, you need to wait for the right moment. So, we basically -- we knew that we could be a piece of the puzzle that these other two companies are trying to address. But we did not really champion this because, otherwise, this would have impaired our -- the economic outcome of the negotiation. And that basically was the reason -- was our strategy all along. And as you can see, very positive because, clearly, very neutral to your other question.

And because we also saved milestones, and simplified the agreement, and obviously are now not forced to invest into a product that we don't control or manage, also 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, what, and how to define profit or revenues or other things. So, I really 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.

And with regard to RSV, I cannot speak, obviously, on behalf of Sanofi; they know this better. In a previous call, we did an outside-in where we -- I think the last one where we also asked people close to the subject matter in the committees and everything [indiscernible]. So, I can report on both assumptions. Yes, I think there is a high probability that they will have sales.

And in that case, depending on how they will record them, I think there is a good chance that we have already material earnings this year because the -- we are proud of this because the way this works is that, normally when a proficient in this space or when you look at analogues' launches you can, even in two months, can achieve a significant market penetration, and there you just need one shot and you have accomplished the sale for that patient there. So, we are cautiously optimistic to see something, but you have to really ask Sanofi how they view this because we can only draw -- extrapolate from what they have said, and we are not in charge.

Alistair Campbell

Great, thank you.

Guido Oelkers

Yes, you're welcome, and thank you.

Operator

The next question comes from the line of Peter Östling with Pareto Securities. Please go ahead.

Peter Östling

Yes, thank you. Can you hear me all right?

Guido Oelkers

Yes.

Peter Östling

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 for '24, and beyond that?

Guido Oelkers

Yes, I mean there is -- it's prudent for sure, yes. It cannot be less than zero, yes. And then you're very prudent there. We hope that in the further discussions that the brand that we owned carries some weight, and we are now rethinking also how to look at this, how to restructure this partnership with [indiscernible], so that maybe we can preserve something. But in terms of materiality, it's not going to be to what we have seen, obviously, last year by any respect. And that's the reason why you need to grow what we have. And we have some really explosive growth right now in Europe even though we don't have all the markets there and we are continuously growing strong.

I look forward to the launches also in Japan and Australia, and then taking the product into Latin America and in the big markets. So, I think that we will -- 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 '24.

Peter Östling

Okay. And just to confirm, did you say that you expect material order in Q2, and then more or less nothing?

Guido Oelkers

Yes, I'm always cautious because we are dependent here on the ordering of our partner. But that is -- we are expecting at least one big order here, and -- yes, absolutely.

Peter Östling

Okay, thank you.

Guido Oelkers

You're welcome.

Operator

The next question comes from the line of Viktor Sundberg with Nordea. Please go ahead.

Viktor Sundberg

Yes, I hope you can hear me well.

Guido Oelkers

Yes.

Viktor Sundberg

So, I had a question on nirsevimab but that was partly answered. But I can go ahead with another question on nirsevimab. So, the payments here to AstraZeneca and Sanofi, will they be booked in the P&L or any other way? So that was my first question.

Guido Oelkers

No, they are milestone payments, they are not really related.

Viktor Sundberg

Okay, perfect. And on Doptelet, 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, 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, and maybe also if you can comment on the growth in Europe versus the U.S. here as well?

Guido Oelkers

Yes. No, I think what we see is really exponential growth in Europe because we broadened the base, the product responds extremely well to promotional effort, and we are coming in at the right time.

In the U.S., I mean this is always you basically -- when you go through this really exponential growth you always hit, at certain point of time, certain milestones. So you think, okay, am I still [collecting] (ph) enough new patients. But that has absolutely -- when you look at the trend this is very powerful [indiscernible] of new patients, new prescribers, this is -- we are the -- we have a ton of them, yes. There is -- I would not worry too much growth now in comparison the way you have done when their government -- the 78% is quite indicative of what we are -- where the product [indiscernible].

And in terms of acceleration also [indiscernible] parameters and the leading indicators, they're pointing all into the right direction. And sometimes there is also some inventory that [indiscernible], which we don't obviously encourage in whatever form or shape. And when it impacts a little bit when you would do the quarterly comparison, but when we look at the leading indicators, they are all very solid.

Viktor Sundberg

Okay, thank you.

Guido Oelkers

You're welcome.

Operator

[Operator Instructions] The next question is a follow-up from Mr. Uhde with SEB. Please go ahead.

Christopher Uhde

Yes, sure, thanks very much for taking my follow-up. So, I guess in terms of SG&A and -- well, so the number of employees basically at the end of last year was basically unchanged from year before, but SG&A excluding amortization was up 25%, and salaries were as well. So, what factors are behind that? How much was related to the restructuring, and how much to other reasons, but while or exceeding core inflation on, what should we expect in terms of inflationary impact on overhead in 2023? And also, what were the 56 new hires in that quarter 4? Thanks.

Guido Oelkers

Yes, Henrik, do you want it?

Henrik Stenqvist

To start, to be clear, if we look at the SG&A in Q1 compared to Q1 last year, excluding amortization at constant currencies, it is virtually flat. So, there is --

Christopher Uhde

And I was looking at the full-year from last year, from then NL report?

Henrik Stenqvist

Yes, okay. So your question relates to '22 compared to '21?

Christopher Uhde

Yes, and then trying to use that to get a sense of the trajectory going forward and what factors are involved there.

Henrik Stenqvist

Yes. Well, when it comes to the increase in '22 over '21, 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. So 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, but that's really balanced increase across the board and for the rest of this year.

Christopher Uhde

Sorry, inflationary impact?

Henrik Stenqvist

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.

Christopher Uhde

Okay, thank you very much.

Guido Oelkers

Thank you.

Operator

Today's last question comes from the line of Peter Östling with Pareto Securities, and his follow-up. Please go ahead.

Peter Östling

Yes. It's not a question, just another confirmation. When it comes to price reductions for within your haemophilia business, did you say that you had already seen some or that you expect some for the rest of the year?

Guido Oelkers

Yes, we have seen some, well, I mean the effect, because we have been executed and we are expecting also, let's say, more to come because they are less because of government but more because of further competitive pressure. But we think that we can -- the way we look at it, that we can compensate this in a way that we have seen also in the first quarter, maybe not to the full extent I mean as far as -- also very nice, obviously, evolution here. But that's how we look at it there.

Peter Östling

Okay, thank you, Guido.

Guido Oelkers

You're welcome, Peter.

Guido Oelkers

I think we can have probably more questions and answers. I guess we have, tomorrow, a call as well. And if you have questions please refer to us. I mean, this was just a first meeting [indiscernible]. And as you can see, we're quite happy with where we are today. Would I have liked to present to you an order for Doptelet also in Q1? Absolutely; wasn't the case. But what I like is that we have -- that our underlying business grows very strongly and that we're doing the right things, and for our pipeline.

On this note, I wish you a great weekend, and look forward to hearing from you. And if there are any questions, please refer to our, as per usual, [indiscernible] coming from a summary, just a short detail.

We think that our perspectives on 2023 is unchanged, but this is more probably also driven by the fact that this is Q1, it's -- and then why would we go ahead of ourselves at this juncture. This is a good business and stronger earnings, strong growth was a product [indiscernible] but as you can see, we manage.

I wish everybody a good day. Thank you.