Swedish Orphan Biovitrum AB (publ)

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Ladies and gentlemen, welcome to the SOBI Q1 2025 report conference call and live webcast. I'm Sandra, the chorus call operator. I would like to remind you that all participants have been listened only mode and the conference has been recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Guido Oelker, CEO. Please go ahead, sir.

Thank you, Sandra. Hello, everyone. This is Guido Oelker, CEO of Sobi. We are delighted to welcome you to the first quarter video conference of 2025 Call for Investors and Analysts. We posted this presentation to Sobi.com earlier today. And, you know, straight to the forward-looking statement, We would like to remind you of the usual provisions on the statement about expectations, projections of future events. Unlike stated otherwise, we will be making comments that most relate to the first quarter at constant exchange rate in million Swedish krona. Let's move to the agenda. Today we plan to cover the following key aspects of the Q1 report. I'm joined by Henrik Stenqvist, our CFO, and Lydia Bart-Franch, head of R&D and chief medical officer. We plan to review the presentation first and then have Q&A until around 4.30 Swedish time. For those on the phone, please join the queue for questions by pressing star one. we propose that you only ask one, maximum two questions at a time. Let's go to slide number four. I mean, as you have seen, you know, this has been a pretty strong quarter with solid performance that we started in 2025. You know, and the stats are as follows, you know, 3% total growth, but I will talk more a little bit about it, and an EBITDA margin of 36%. but the portfolio grew 23% if you exclude the RSV seasonal products and the discontinued refacto manufacturing revenues. This reflects a solid performance across the strategic portfolio that grew at 46% and is now close to 50% of our entire business. And the hematology was driven by continued growth of Doctelet, Asper Valley, and the launch of Altoworked that generated $455 million in the first quarter. We continue to build and deliver on our clinical development milestones and look forward to seeing the progress of our pipeline with the exciting potential for Gamifund, Asperveli and NASP. And, you know, when you go a little bit more deeper into the different business areas, you know, obviously we look forward to continue driving the AltaWork launch. We'll talk more about it. And, you know, when you think about, you know, immunology and also a little bit more later, I mean, Gummy Fund with over 30% in kindred have performed extremely well. So in terms of pipeline, I think, you know, our progress with filing gamifond for HLHMAS and still disease in the U.S. receiving a priority review with a PDUFA date late June was clearly a highlight and Asper Valley was submitted to EMA for the potential treatment of C3G and ICMPGN. And we'll continue the discussion with health authorities and look forward to bringing this product to the market pretty soon. So overall, it's a combination of strong business momentum whilst hitting important milestones in development and filing. Let's move to slide number five. And when we look into the performance in more detail, as you can see here by business area, very strong momentum in hematology, hemophilia here slightly reduced by the discontinuation of the manufacturing. But when you think about hemophilia A products growing at 29%, I think this speaks for itself. And immunology, let's say down, But if you take away the synergist sales that we have now consolidated de facto in Q1, due to the obviously incoming bifortas, basically immunology is growing over 20%. And this shows that there's robustness across board. When you think about the geographic split, Europe having obviously a fantastic quarter with 19%, And if you take away the synergies effect on North America growing at 24% and international at 38%, I mean, these are very strong numbers and speak for a very strong commercial execution. Let's move to the next slide, number six, focusing more a bit on the portfolio. And, you know, I'd just like to highlight, you know, the performance of Altevocht, the performance of Dr. Lid with 47%, the performance of Asper Valley with 39%, the performance of Kinneret with 16% and the performance of Gamivant with 31%. So, very strong quarter and we'll talk about the performance of Wonjo in a moment. So, let's move to the next slide and a more specific review by product. We are pleased with the continued strong growth of Altowagt and the rapid adoption in quite a few markets, but foremost in Germany. And there we have achieved a market share position of 57% after nine months within the launch phase. And this shows what is possible with this product. This is over 24% market share gained within the space of time. And we see very promising trends also in other markets. So we look forward to bringing this important medicine to more markets across Europe and other SOBI territories. Let's move to Asper Valley. And, you know, what we are facing with Asper Valley, obviously quite a bit of competition from new oral medicines. We continue seeing significant growth and you can see that we had a pretty strong Q1. And this is more primarily driven by progress in international markets. But I think, as we always said, the primary story for us is really about the nephrology indication that we are looking forward to. And we are very keen now, let's say, to bring this product to the market because the combination of very significant reduction in proteinuria, clearance of C3 staining, from the kidney in a high percentage of patients and the stabilization of EGFR at such an early point of time make us really excited and make us believe that this is an important product in those two indications. So we look forward to working with the regulatory authorities to move this forward in parallel and being, let's say, building an internal infrastructure and nephrology to prepare the launch, and this is what we are currently doing across the organization. Let's talk about Wanzhou. So the demand for Wanzhou grew quarter on quarter, even though you see here a minus six in Q1 versus previous year. However, these sales were pretty much impacted primarily by stocking and partially by gross-to-net adjustment, including Medicare Part D reform in the US. And this led to a decline of 6% in revenues, and we aim to resolve this in the coming quarters. Our ambition remains unchanged, and our near-term focus is to continue growing in myofibrosis, leverage the guidelines, the NCCN guidelines, and ultimately see growth outside of the restricted area of below 50,000 plate lengths that we have on label. So, and you know, the growth strategy is more explicit than on the next slide. So, as you can see, you know, our glass for Bonjour is clearly not even half full, and there's clearly a thirst for So looking at Juonjo overall, we still see significant potential to be unlocked in myofibrosis. But we realize also that leapfrogging in terms of performance will really take a change of guidelines and label expansion. And we are working on this. This year we'll launch in some of the additional smaller countries outside of the US, but ultimately we need the PACIFICA Phase III study for both full approval in the US and filing in Europe and Japan. The next step is also to broaden the use of WONJO. And we have started a Phase III study for WONJO assessing its potential in vexers. and it's an area with currently no approved treatments, and we have a strategy with CMML, and we believe that there's a very strong mechanistic rationale for Bonjo in this space, and there's also broad overlap of prescribers with myofibrosis. So let's move to Bifortis. As the headline describes, Bifortis now follows much more the seasonal sales pattern of vaccines. And, you know, as illustrated in the graph, the sales predominantly occur in Q3 and Q4. And, you know, this is new for us at Sobe because, you know, with Synergis, we obviously had also always a very strong Q1. But given that this product is only given once a season and not five times, obviously the sales pattern has changed. So important to note that our share of sales by Fortis goes from 25% in 2024 by a tiered rate starting this year until 28, reaching a range of 30 to 35% of net sales. Beyond 2028, the royalty rates will remain fixed at these levels. So we obviously are here very much dependent on the performance of Sanofi. But for us, we may be benefiting not only from the business growth, but also from a royalty improvement. So let's move to immunology and to Kineret and Gummy Fund. And as the headline suggests, our immunology revenues grew 22% in Q1 when you exclude the RSV revenues. So outside of RSV in immunology, both Kinrad and Gamifund have shown strong and sustained performance. Gamifund continues to exhibit significant growth despite high penetration in the primary HLH market. And we are looking very much forward to the launch of secondary HLH indication with a regulatory decision to be expected by the end of June. So far, we have seen no delays and the filing Spares all on track to meet the PDUFA date of June 27th, 27th of June. Let's move to the next slide. So when you think about us or Sobi moving into the future, I think it's nice to just think of a very simple formula. Two, three, four. Because when you think about us right now, we have two major launches ongoing. One of them displaying exuberant growth with Alturoct, as you have seen. One still, you know, we have some work cut out for it. But we have very important filings ongoing with Gamifund entering secondary HLH. With Aspavelli, let's say entering into, or we have filed for the really primary indication for us in nephrology, in the two nephrology indications. and NASP, which will be also a very material product to us, as we believe, in chronic refractory gout. And then we have four projects in development, and here we're taking a stand that we take our existing compounds into settings of high unmet medical need, into IDS, interferon-driven sepsis, into Wanzhou into Vexus, as we pointed out, Wanzhou into CMML, and taking AltaWorks into survival.

affected by the loss of lower margin refactor sales, as well as product and country mix in various products. And this was partially offset by lower RSV sales and royalties. And as said, the adjusted EBITDA margin reached 36% compared to 37% last year. Looking at operating expenses for the quarter, we observed an 8% growth at CER compared to the same period in 2024. FG&A, excluding non-recurring items and amortization, increased by 10% at CER in the quarter, driven by launch and pre-launch costs for Altebox, Vasta Valley Nephrology, and NASP. R&D expenses increased by 3% at CER. excluding non-recurring items, mainly due to post-approval activities for Altevoxt and development programs in Gamifund and Bonjo. We now see lower costs in NASP-related programs compared to in 2024. Operating cash flow for the quarter was 2.3 billion, slightly more than in June 1, 2024. Net debt continues to go down, ending the quarter at 12.7 billion SEC, corresponding to a net debt to EBITDA ratio of 1.3 times compared to 1.6 times at the end of the previous quarter. So please turn to slide 16 and the financial outlook for the fall year 2025. As usual, this outlook is based on revenue growth at constant exchange rates and adjusted EBITDA margin. For the full year 2025, our outlook is unchanged. We anticipate revenue to grow by a high single-digit percentage at CR and an adjusted EBITDA margin in the mid-30s percentage of revenue. On the revenue guidance, the drivers are the same as when we presented this guidance in connection with the Q4 release. First, for AltaVox, we've seen a strong launch in Germany and Switzerland, early launch sales in Spain, and we look forward to continuing to launch the product into new markets in 2025. We also expect continued progress with our existing commercial portfolio, and we continue to expect a strong contribution from Bay Fortis royalties, although this is a factor where we do not control the outcome ourselves. In regards to our Evita margin guidance, we will start to ramp up investments in our pre-launch assets specifically NASP and ASPA Valley in nephrology, starting later this year. In R&D, we will also continue with post-approval studies for Altabox and the new studies for Bongeo in Vexus and CMML, as well as the registration of efforts for ASPA Valley, Gamifat, and NASP. Please turn to slide 17. And finally, I wanted to spend A few minutes on currency exposure on our P&L, considering the recent appreciation of the Swedish krona. The chart gives an illustrative view on our exposure and the split between currencies for revenue, as well as OPEX and COGS. Our revenue is dominated by sales in US dollars and euros, with only a minimal share in Swedish krona. So anytime there is a currency movement, this will have an almost one-to-one impact on revenue in SEC. For cost of goods sold and OPEX, around 15 to 20% is in SEC, with the remainder primarily in dollars and euros. And this means that the impact from currency movements on EBITDA will be slightly larger, relatively speaking, than the impact on revenue due to the cost we have in SEC. Overall, the absolute numbers of revenue and costs will fluctuate with currency movements, but the beta margin is relatively protected from changes in FX rates due to the natural hedging that comes from the composition of currencies in our business. And with that, I hand over to Lydia. Thank you.

Thank you, Henrik. And hello, everyone. We will start with the pipeline milestones on the next slide, please. Can you move to the next slide, please? Thank you. We had a very productive first quarter seeing important regulatory filings and clinical progress. In February, we successfully submitted the EU application for Aspavelli in C3G and ICMPGN, which has since been confirmed by EMA and it's now making steady progress. Gamifam received FDA priority review for our HLH-MAS-US application with a PDUFA date at the end of June. On the clinical side, we initiated a research collaboration to explore Gamifam in interferon gamma-driven sepsis, also known as IDS. The synovitis shine phase four study with Altubox in hemophilia started enrolling patients. And the VEXAS proof-of-concept study with pacretinib, which we discussed at the last quarterly call, is starting up. Finally, our Japanese study with kineret in Stills disease delivered positive top-line data, paving the way for a submission later in the year. As Guido said, we are maximizing the opportunities to innovate and expand the use cases for our medicines. The synovitis and the IBS sepsis studies demonstrate this well, so I would like to explain them a bit more in depth. Next slide, please. Thanks. Starting with gamifan and interferon gamma-driven sepsis, which could address a significant and medical need with important burden to healthcare systems. Sepsis is a life-threatening medical condition which arises when the body's response to infection causes injury to its own tissues and organs. This can lead to shock, multi-organ failure, disability and death, especially if it's not recognized early and treated promptly. It is a leading cause of death worldwide, responsible for about one in five deaths. Almost 50 million people suffer from this condition and 14 million died from it. It also leads to high healthcare costs with an estimated $60 billion in the US alone. Recently, an endotype of sepsis has been identified, which is characterized by elevated interferon gamma and CXCL9. Referred to as interferon gamma-driven sepsis, IDS, this endotype represents an increased risk for 28-day mortality, irrespective of the type of infection, comorbidities, or organ dysfunction. Since emapalumab neutralizes interferon gamma and blocks signaling that leads to hyperinflammation, we have initiated a research collaboration with the Hellenic Institute for the Study of Sepsis. The Phase IIa EMBRACE proof-of-concept study in patients with IDS will explore if emapalumab can improve outcomes in IDS. The study has started, is actively enrolling, and the first patients have been dosed. It has two treatment arms, and one placebo arm each with 25 patients. And we expect top-line data in the second half of this year, which will inform next steps for this indication. Next slide, please. The Shiner study for Altubox in patients with synovitis is building on the ability of Altubox to maintain factory levels in the non-hemophilia range for most of the week. This changes the treatment paradigm for this chronic condition, allowing for unprecedented levels of protection. Increasingly, targeting non-hemophilia levels is seen as achievable and recommended, for example, by the German Society of Thrombosis and Hemostasis. Joint health is becoming a focus. It is a key concern for hemophilia patients and their physicians because most patients experience joint deteriorations from microbleeds, which cannot heal without adequate hemostasis. In haemophilia patients, bleeding inside a joint lead to blood accumulation in the joint space. This repeated bleeding irritates the lining of the joint called synovium. It becomes inflamed and thickened over time. Untreated synovitis evolves to irreversible chronic arthropathy. And between 22 and 55% of people on prophylactic treatment have synovitis, making it the most common complication in haemophilia. The medical community is very keen to know if the high sustained factor VIII levels provided by Altubox can contribute to prevent and improve synovitis and joint damage. The SHINE study aims to analyze hand-dread joints with synovial hypertrophy from approximately 35 patients. Additionally, our partner Sanofi is conducting a twin study in their territories. with the same setup, allowing us to perform post-hoc analysis with combined data from the two studies and evaluate up to 200 joints with synovial hypertherapy. Next slide, please. Looking ahead, we continue to be busy with the submissions to the major regulatory agencies, FDA, EMA, and PMDA, for our key assets, Gamifan, Aspavelli, and NAS. In the U.S., the focus will be on the approval of Gamifan for HLH mass in Stills disease and on finalizing the submission of NAS for uncontrolled gout. In Europe, the focus will be on the approval of Aspavelli for the nephrology indications C3G and ICMPGN. And in Japan, we will be submitting three dossiers, Gamifan for HLH mass in Stills disease, Kineret in Stills disease, and Aspavelli for the nephrology indications. The Aspavelli submission in Japan will now include the 52-week data, which moves the submission timeline to the second half of this year. And with that, I would like to hand back to Guido. Next slide, please.

Hi. Yeah, thanks, Lydia. I mean, and let's go straight to the summary. You know, as you can see, you know, we were very pleased with Zuby's development during the first quarter. We saw significant top-line growth of 23% excluding the seasonal RSV revenues and the final manufacturing sales from Q1 last year. The overall strategic portfolio is delivering well and growing at 46%. Our R&D pipeline has shown tremendous progress with the continued successful launch of Altevocht in Europe the filing and granting of a priority review for GAMI Fund in the U.S. for secondary HLH and the filing in the EU for Aspar Valley and nephrology. We will continue this pace with the planned completion of the NASP filing of uncontrolled gout in the U.S. by Q2. Building on these, we have four areas that we are going to leverage in our portfolio with the studies that you just saw in synovitis, in hemophilia, interferon, gamma-driven sepsis, vexes and CMML. This will open tremendous opportunities for SOBE in the coming years and we are actively preparing of these new launches in 2025 and continuing the expansion of ongoing launches with the strategic portfolio products. We have some momentum in this business, in our business, and obviously momentum also in the pipeline development. And we are continuing, looking forward to continue this journey with our colleagues and stakeholders around the globe. And now please move to slide number 23. We now open the floor for questions. For those on the phone, please remember to press star one to ask the question. Can I ask everybody please to limit questions to one or two to be fair to all callers. Thanks in advance and perhaps we can take the first question. Back to the operator.

Thank you, sir. The first question comes from Shirley Chen from Barclays. Please go ahead.

Hi, thanks for taking my question. Congratulations on AutoVox to achieve 57% share in Germany. Just wondering if this would adjust your expectations for the market share of AltoVogt in the market across Europe? And also, can you perhaps share some initial feedback from Switzerland and Spain markets? Thank you so much.

Thank you. I mean, the 50%, sorry, I should be precise, includes also Elocta, while the vast majority is coming from AltoVogt. So it's our Haemophilia A share, primarily driven by Altovox, and the 24% gain in the Haemophilia A class in Germany is driven, obviously, by the Altovox expansion. But, you know, it is now an example, I mean, the launch successes in Switzerland also look very promising, you know, In fact, the trajectory doesn't, you know, it's earlier, but it doesn't look less impressive, just less, there's a lower number, obviously, of patients in Switzerland and Germany. And, you know, in Spain, it will take, we have some very strong signaling already, but it takes a little bit of time because you need to get the reimbursement accepted by the regions, and this is currently ongoing. But we are very optimistic that, you know, This is ahead of our expectations, to be quite frank. I mean, we always said 30 to 40 would be a good ambition on a consolidated share. As you can see, we can break through this, but we'll have to see whether this is already indicative, this high number. But I'm sure that our country managers in other countries don't want to look too shy. But if anything, we are more confident about the product in our territory. Maybe the next question.

The next question comes from Mattias Heggeldvorm from Handelsbank. Please go ahead.

Good afternoon, Mattias Heggeldvorm from Handelsbank. Two questions, please. So firstly, your partner Sanofi stated last week that due to lower immunization rates in the US during Q1 before the shift in Q4 may be stored and used for RSVCs in 2025-2026. So the question goes, Has your partner quantified the SOGA, how much they think remains in stock, and how, if at all, has that informed your outlook for 2025? And then secondly, if you could remind us of your appetite for M&A in light of the very rapidly deleveraging balance sheet. And if there is appetite, what profiles are you looking for? And if there is no appetite, why not? Thanks so much.

Yeah, thank you Matthias for the two questions. So the first one, I mean, you know, basically our annual ambition for the product is unchanged because, you know, we have also no indication from Sanofi that they revised their annual ambition. Yes, there is stock, but, you know, as the opponent will out, but, you know, frankly, I mean, we know this from our own experience, you know, there's always an overhang of stock. in the trade. And then the question is, can this be digested and at what rate? But the fact remains that the majority of the sales are there, but not very long ago. I think Sanofi mentioned also that given the relatively low immunization last year of 55, 60%, let's say they feel that as a gross opportunity, we'll have to find out in this environment how this works. given that the royalty rate is going to increase. So we'll figure. But we have no indication from Sanofi in this, let's say, to dampen our expectations for the year. And one has to say also that Sanofi can only share things with us within reason. I mean, given the residual competitiveness with Synergist. And with regard to M&A, it wouldn't surprise you that we are very vigilant right now and thinking how we can intelligently expand. I mean, you see from the portfolio that we have that we have quite a bit to do now very near term. And therefore, we are now thinking how we can develop the company on a going concern basis also into the mid and longer term and looking for products that are giving us leverage and uh and are suitable to our existing portfolio and and this process is ongoing and we're looking currently for for various opportunities thank you thank you and then maybe move to the next question the next question comes from christopher ud from seb please go ahead uh yeah there hi um thanks for taking my questions um i think uh my uh

The thing I'm wondering most about is what are the gating factors for launching Altevocht in France and UK now left? That's my first. And my second is just with Aspavelli competition, we saw this kind of, I mean, decent performance last quarter, but definitely missed expectations. Now well ahead of expectations and very good growth. How should we think about the dynamics in P&H? And let's say, are there specific patient groups or niches where you feel more, I don't know, insulated or stronger relative to the competition? Could we see price pressure, or was that a factor in Q424? Thank you.

Yeah, thank you, Christopher. So maybe with regard to the easy one, In the UK, we are currently operationalizing this. We have got the positive votum from NICE and working on this now. We don't see any more problems. And in France, we are in active discussion with the Transparency Commission to resolve this and look forward to a launch during the course of this year. But we don't want to put ourselves under too much pressure because we have Strong momentum in any case, and we have enough countries currently on the plate already. But we want to launch obviously in France and to make this product available everywhere in our territory. As far as Asper Valley is concerned, it's good that, as you see, we had a pretty satisfactory Q1. I mean, primarily, let's say, driven by the launches in international region. And what we can see is also that we are now getting all the patients back from the orals because it seems, you know, that sometimes, you know, a more central, you know, effect on the C3 inhibition for certain patients, not for all, may be more beneficial and to be more proximal. And, you know, but we have not yet deciphered, you know, major patterns, but we know that the product is... is very suitable, and we also think that the launch by end of the year in various countries of the new device will make the administration easier, take away the burden of administration, and will strengthen our competitive offering in P&H. May we go to the next question?

The next question comes from Harry Gills from Birnberg. Please go ahead.

Thank you for taking the questions. You mentioned some operational improvements relating to Bongeo. I was just wondering if you could please expand on those and what they entail and perhaps some of the measures you're taking to help drive growth on that product. And then just a quick one on the gamma band indication expansion. It's obviously the PDUFA's end of June. Just wondering, should we see some sort of sales inflection in the second half of this year, or will this be more of a gradual increase over the next couple of years? Thank you.

Thank you. Let's start operationally with Wonjo. I mean, we have a two-pronged approach. significantly strengthened our medical area and we have Jamie Freeman from previously head of medical at Genentech in the US and we have also recruited quite a few, you know, we have now retained a very strong KOL in the field and on a permanent basis and we have also, we are also let's say improving the the medical organization as such as we speak. Then we also realized that because we needed to have a stronger outreach to the key centers again, we are working obviously, the two studies that we are currently working on will help us also to reconnect to the academic centers and bring us back in on top of mind And then we are working through the metrics with our team. And there we saw some softening and we have taken and we have introduced some change at leadership levels. So this is what we are doing for Wonjo. And with regard to Gummy Fund sales, I mean, the product is utilized already and other indications, as physicians indicate. So this will probably be a gradual, but we expect that this obviously will enable Gummy Fund. We indicated in the past that we're expecting to double the product, essentially. But this will not be from zero to hero. It's more a gradual buildup now of the product over time. Next question, please.

The next question comes from from HSBC. Please go ahead.

Thank you. Hello. Hello. Thanks for taking my question. I was wondering if you could comment on the sort of environment of BD and given all the macro volatility and unknowns, et cetera. And has anything changed on your approaches to BD? And secondly, perhaps you could comment on some of the changes we see. maybe with the FDA and how do you see that affect your regulatory activities? Thanks.

Thank you. I think, you know, every, you know, in a way crisis is, you know, a threat and obviously an opportunity at the same time. It's a, you know, as we know, many, you know, companies are running right now out of funding and, you know, it's You could argue that some of the companies who run out of funding, probably should run out of funding, some others become obviously significant opportunities. The value of cash is clearly more pronounced, why it's for good assets. There's always competition, but it's clear that the environment for buyers right now is more favorable than it was maybe a year ago. And so this opens up for opportunities for a sourcing company. And therefore, we are quite encouraged to look for this because, you know, there is more uncertainty baked in. But if you have a, I would say, more level-headed view and a longer-term view and you believe in this industry, you should be undeterred. With regard to the changes of the FDA, We have not felt, I know that there have been reports recently out, but we have not felt this. We have seen that we have got the priority review for GAMI Fund and we are working towards these timelines. So we cannot comment that we have any changes to the FTA. But obviously, we also read about those changes in terms of employment structure. But so far, we cannot comment anything in either direction. I think we look forward to launching GAMI Fund pretty soon.

Thank you.

Thank you. Next question, please.

The next question comes from Natalia Webster from RBC. Please go ahead.

Hi there, thanks for taking my questions. I have two follow-ups. The first on Bonjoe, given Q1 was also impacted by some stocking effects, are you expecting this product to grow on a full year basis given the operational improvements you talked about? And my second question following up on BD, Is there a desire to add novel molecules to the pipeline as apart from NASP, the development pipeline looks to be predominantly focused on line extensions for marketed drugs at the moment? Thank you.

Thank you. Yeah, no, it's clear. You know, we will, I mean, we are absolutely convinced that we can grow one draw doing this course also here. For us, anything less would be big disattainment. I mean, Frankly, we had a couple of disappointments with the product already and I wished we would have made faster progress. It's clearly not a lack of effort. It's tough. We obviously, a further guideline change and a label change would make it much