Swedish Orphan Biovitrum AB (publ)

Yes. Welcome everybody.

It's really a great pleasure to have you here on the Sobi call knowing that we are competing this quite another -- quite a few other earnings calls. So I go right into it.

We'll start with the forward looking statement as per usual, and please take not of this. And then I come to the presenters of today, this is Henrik, our CFO and Milan, our Head of R&D, who will join me for this call.

And with this having said, these are obviously unprecedented times, so I go to slide number four, and very challenging times. So before we talk about our very significant top line and -- top and bottom line growth, just wanted to tell you that we the absolutely take this situation very seriously and take charge.

So for us the first priority was to make sure that patients requiring any of our products get access and we have achieved this. So we made sure that the supply chain has been ramped up in view of this new situation.

For us, it was also important to make sure that our team is protected and we took the right measure in the early stage in terms of virtuality of our office environment and also travel restrictions. But we also want to make sure that we are staying in contact with our HCPs in the proper way and to make sure that we respect obviously their priority of today, but still make sure that they also understand that we do care.

In addition we have been able to launch indeed and bring on board the digital agenda for Sobi. We have launched Florio, and Florio is really all about liberating life and making sure that there's few compromises for haemophilia patients as possible.

I think this was an important strategic move for the group. And we have expanded our footprint internally into China and we are on the way to do the same in Japan.

And this bolstered by a very strong financial profile that Henrik is going to explain further in his part. With this, having said, what are results?

I mean, I think you have all seen the headline results, 42% growth on the topline, 44% earnings growth, so pretty strong results. And when we go straight into the different business areas, you can see these results become pretty much alive.

We had a very significant uptake, also a constant currency with Kineret, driven by the COVID related indications of the hyper-inflammation as a results of COVID infection. We had spectacular growth Synagis, so we ended to see very, very strongly, and has been able to confirm our Q4 results with Synagis.

So the product has to form extremely well under our ownership. And with Gamifant, I think its important to note that we had 17% at actual currency, 11% at constant, but we had a quarter-on-quarter patient growth and please remember that the Q4 results were very strong of 21% patient growth and the current sales situation is basically a transition into a larger patient pool that we have followed with some concessions on pricing.

So when we come to hematology, we are very happy that we have been growing to drive this franchise at 34%, obviously driven by our hemophilia products and I will come back to in the later part in the presentation and we made our first strides with some Doptelet. Basically when you think about on page six, how the group is developing.

So basically what we have told you in the past is happening now and is supported by our results. The two core businesses have really grown exponentially, and Immunology has become an important second pillar in this franchise, and that's very gratifying that basically, our strategy is yielding the results.

When you go to the next slide on page seven, basically the -- if you summarize this, we still have the appetite to grow haemophilia as we see the positive momentum to do so and I will talk about some of the -- some of the markets in a few moment. We have launched Florio is just one example.

With Doptelet, we have made our first imprints -- the first 450 patients in ITP, so not significant, already the impact in a very difficult environment. And CLD, we are planning for launching in the EU and we just got recently also the CLD indication approved in China.

And basically when you come then Immunology, we really want to further expand Gamifant, as we told you earlier into secondary HLH indication and acute graft failure. Milan will talk about the clinical trial that we are currently -- that are currently ongoing and the clinical activities with Gamifant and also with Kineret.

And obviously for us its important that we continue driving Synagis. So basically what we want to leave you that these challenging times really stimulate our appetite to do more and to more in terms of supply chain ramp up, making sure that our products go through the clinical process and obviously that we make sure we stay in connected to our key customers and think about new tools and new ways of interacting with our customers and staying true to values, know that about ambition, about urgency, ownership, but also about care.

With this having said, I'll go to straight to the Hematology business review on page 10. As you have seen from our report already, the Hematology business has been doing extremely well.

I just want to bring a little bit of light to the first data for Doptelet, to SEK65 million in the first quarter was quite rectifying to us, particular as we were in the transition on the CLD indications in the U.S. to transition out of Salix and taking charge ourselves.

We think that with Doptelet we made the first impact. Obviously, its not easy to launch the product in a more virtual access, but we believe that we will have strong second quarter and we're currently adjusting our commercial model accordingly.

So going into the hemophilia products on slide 11, Elocta has made significant strides and the growth countries that the customer is coming from is Spain and CEE, but also -- it's Germany and Italy that have significantly contributed to the growth. One should also highlight that the largest part of this growth is really coming from patient acquisition and share gain.

And Henrik will talk more about this. And let's say, there has been a supply chain effect, but this is minority part of these gains.

With regard to Alprolix, also here it’s a very strong demand growth and this continues in key markets and its quite nice to see that we got Spain approved. With this having said, I just want to have a couple of words on our digital platform called Florio.

So as you can see here, this is a fully integrated platform that allows patients to basically know exactly what they can do at a given point of time and how they can adjust their life and basically are in a position to have a very active life to manage disease as oppose to forget about it and on top we are connecting the patient with the physician. So we feel that it is a very relevant tool and we are now in the launch phase.

We have set up a separate company to enable this technology and we're saying that will be very useful for the patient community. Coming to Immunology, as you can see here on page number 14, the Immunology business has penetrated from fantastic season with the Synagis.

So significant uplift and the product is really performing well. We have some initial topics with the supply chain.

So we are now in the processes to fix those and be even stronger for the next season. And so for us, this is a -- this was a fantastic acquisition and supported the strong organic growth.

Kineret, I will come back later and so also for Gamifant. But overall, the franchise has performed very well.

And when you come to Kineret, the good news is we keep growing our existing business very well. We got a positive CHMP opinion for the specialized indication called Familial Mediterranean Fever.

Basically, our original, let's say, strategy to build this business based upon rare disease indication, we continue. And now basically, we got on top the opportunity in the COVID-19 pandemic.

And here, we have utility in the hyper-inflammation as we rise out of this and already a few thousand patients have been treated, and the product is in clinical research corporations, over 500 patients. And this number is bound to increase over the next couple of weeks.

So very excited that Kineret can help patients in this very serious situation. Coming to Gamifant, I think it's important to have a relatively quick recap what the product is really all about.

The -- what we can say is there's a compelling evidence that interferon gamma contributes to clinical condition seen in HLH patients. It has demonstrated efficacy in neutralizing interferon gamma.

Our clinical development programs are continuing very well and Milan will talk about this, but only as much, the MAS/sJIA study enrollment has been completed. So we are on track with this study, very gratified that we were able to do so.

The secondary HLH adult's patient study is -- has been opened for enrollment, and we are also preparing the graft failure study. So basically, what we announced some time ago, we are doing and we are staying true to our strategy.

In addition, interferon gamma now has very likely and some significant role in the cytokine storm syndrome. And this led us to believe that we should study this, and this we have been doing -- what we're doing currently in the Italian trial that Milan will talk about later.

So when you think about our Gamifant strategy, we are basically in the midst right now to evolve from an ultra-niche rare indication, primary HLH in a narrowest definition to a primary HLH that basically according to the natural definition that covers in the U.S. a broader patient pool.

And we are trying very hard to enable this move and basically the 21% patient growth versus Q4 is the first proof point of this develop [ph]. But this will take some time during the next 12 to 18 months to basically take a fair share of this larger indication.

MAS/sJIA is going to come after we have submitted our trial and Milan can give you there an outline, but we are on track as we told you and we expect to submit before end of year. And basically, then we will take this franchise internationally with these indications into Europe, Japan and China and followed by other indications that will open up the product.

So we are very happy that we have this product. It's in a very exciting compound.

We are obviously now with the potential utility in COVID-19 induced cytokine storm syndrome, we have -- we are on the way to show additional utility. That's the reason why this is more of a illustrative example that build upon what we have already announced that we -- we think that we may be able to do more for this product and would like to update you in due course.

But at this point of time, I would like to refer now to Milan who will share with you some of these exciting developments that we are currently doing in R&D and then has a particular, let's say, part of his presentation where he talks about the cytokine storm syndrome and the role of our products in this. Thank you.

Milan, please?

Thank you very much, Guido, and hello, everyone. On this slide, we're illustrating the role of the cytokine storm syndrome within patients with severe COVID-19 infection.

So as you're probably well aware of, there's accumulating evidence now indicating that hyper-inflammation caused by cytokine storm syndrome contributes to the complications of severe COVID-19 infection, which also includes the acute respiratory distress syndrome that significantly contributes negatively to the mobility and also the mortality of the disease. And what we find is that this disease has some characteristics that are similar to what we're seeing in HLH, including the elevated cytokines.

If I can have the next slide, please. So this is what we're illustrating.

On this slide where essentially an overactivation of the immune system following the COVID-19 infection leads to an uncontrolled self-stimulatory activation of the immune system with some of the main culprits being IL-1 and interferon gamma. And it's on this basis and also in response to a request of the Italian government that we initiated the clinical study looking at anakinra and emapalumab on top of standard of care in patients with known hyper-inflammation and with a high-risk of requiring ICU admission and also mechanical intervention.

And our fundamental hypothesis is that anakinra and/or emapalumab, these interventions would reduce the number of patients requiring mechanical ventilation. And if I can have the next slide.

So this slide illustrates our R&D pipeline. As Guido mentioned and as discussed previously, we have made a significant effort to strengthen our pipeline within the areas of our core strengths, being within Haematology and Immunology.

So we have two ongoing Phase III studies, one with the BIVV001 in collaboration with Sanofi and one for avatrombopag in chemotherapy-induced thrombocytopenia. Then we have the Phase II/III study with emapalumab in adults with nonprimary HLH, and we have the COVID-19 study that we just mentioned and the Phase II study where we recently completed enrollment in patients with MAS, being treated with emapalumab.

In the registration phase on the right-hand side, we have the primary HLH indication with emapalumab in Europe. As Guido mentioned, we have favorable opinion from CHMP for Familial Mediterranean Fever with anakinra.

We have the chronic immune thrombocytopenia application with the avatrombopag under review in Europe. And we've hence, also filed the -- or to submit to FDA the indication DIRA, or deficiency of the interleukin-1 receptor antagonist, in the U.S.

in 2020. So in addition to that, we have the option for the immuno-oncology at Phase I asset on the left-hand side, and we also have the financial rights to the follow-on molecule within RSV virus, which is in Phase III now.

So all in all, we have a very strong pipeline, I think, with the potential to really keep the company growing also into the future. And with that, I want to hand over to Henrik for the financial results.

Thank you, Milan, and good afternoon, everyone. So let's start with the revenue bridge since Q1 2019.

Revenues for Q1 amounted to SEK4.639 billion, and that's corresponded to an increase of 42% and 37% at constant currency. SEK179 million of the reported number was related to the impact from positive FX movements.

Our Haematology franchise, consisting of haemophilia and Doptelet, was the largest contributor to growth, with SEK588 million, an increase of 34% at CER. Elocta and Alprolix export showed strong growth, 33% and 41% at CER, respectively.

This growth was mainly driven by continued patient growth, but was also impacted by increased stockings due to the uncertainty of COVID. And for clarity, outside of Haematology, we saw only limited stocking impact during the quarter.

Furthermore, we also saw first full quarter of Doptelet sales with reported revenue of SEK65 million. In Immunology, we saw Synagis sales of SEK1.196 billion, corresponding to a growth of SEK471 million at CER year-on-year.

And as a reminder, the year-on-year growth was partially impacted by the full quarter of sales compared to Q1 2019. AstraZeneca reported sales of $26 million in Q1 2019 for the period before we took over the product.

And since we need to evaluate Synagis not on a quarterly basis, but rather over the RSV season, we should also consider the season-to-date revenue number, which was $312 million from Q3 to this quarter. And we do not expect any material sales in Q2, but this is anyway a double-digit growth compared to the previous season.

Kineret sales for the quarter were SEK501 million, an increase of 39% at CER. And as we heard, we saw continued strong underlying growth fueled by the increased clinical interest related to the potential treatment in connection with COVID-19.

Gamifant sales of SEK104 million continues to show the volatility in the quarters due to the nature of the disease and the still small patient population. In the Specialty Care area, revenue for the quarter declined by 2% at CER to SEK445 million.

And as we mentioned in Q4, we expect Specialty Care to decline by SEK300 million to SEK400 million in 2020 compared to 2019 as we are discontinuing various products now. And if we go to next slide, please.

And move from -- move on from the revenue. We saw gross margin of 78% in Q1 compared to 76% in Q1 2019.

And due to the seasonal product mix effect, primarily driven by Synagis, gross margin will likely be slightly lower in Q2 and Q3. The adjusted EBITDA number reached SEK2,173 million for the quarter, an increase of 48% and corresponding to a margin of 47%.

Obviously, the margin in this quarter as well as in Q4 is impacted favorably by the seasonality that I just mentioned. Also, the adjusted EPS adjusting for nonrecurring items for the quarter was up 32%.

Furthermore, operating cash flow of SEK2 billion for the quarter, signaling continued strong operating cash flow, coming from a controlled working capital and a very strong underlying performance. And as a result of the strong operating cash flow, net debt decreased from SEK15.4 billion at the end of last year to SEK14.2 billion at the end of this quarter, which we will now take a look at on next slide, please.

And we turn to the development of net debt per quarter. In 2019, we completed the acquisitions of Synagis, emapalumab and Dova, and with that, we levered up to a net debt of SEK15.4 billion.

Now in Q1, we reduced net debt by SEK1.2 billion due to the strong operating cash flow of SEK2 billion, but partially offset by negative currency effects from our debt in euro and dollars. And at the end of Q1, this gives us a pro forma leverage of well below two and half times and an available liquidity of about SEK7 billion, which provides us with opportunities going forward.

And if we go to the next slide, please. Finally, I wanted to give a perspective of where we stand with our business during COVID times.

And this relates to what we've seen in Q1, and we are, of course, aware of the considerably uncertainty related to this pandemic going forward. First of all, we continue to see an unchanged strong demand for our products, in some cases, like in Kineret even an increased demand.

And next, thanks to our technical operations team and our partners, we continue to be able to supply product to our customers. And furthermore, our strong cash flow relies on receivables being under control, and we do get paid timely by our customers.

And finally, we have very strong liquidity reserves with available liquidity of about SEK7 billion, which provides not only a safety net for our business but also allows us to continue to invest in our business and to look for new business opportunities. And with that, I say thank you, and back to Guido again.

Yes. Sorry, we have a technical glitch here.

So I just wanted to share with you that we -- just to summarize, we have an appetite to further expand our position in haemophilia. We think that there are significant opportunities, when we see that we can still convert patients.

When you think about it, we had a high single-digit percentage growth of patient growth versus Q4 and Q1 for both products. And this does show that we are still relevant and we have a fantastic team to drive growth in this area.

With avatrombopag, we are obviously super excited to drive the product into the new indication here for more CIT. We have over 100 patients now recruited or enrolled in the study, and this means that we're actually well on track to meet our endpoints with the study.

In ITP, we are filing in Europe. CLD, we got approved in China.

So we think that this is going to be a significant product for us. With regard to Immunology, we -- as we explained, we have anakinra and emapalumab now in COVID-related hyper-inflammation studies in the pivotal environment.

We have also tried numerous research collaborations that we would like to update you on this during the Q2. And we think that there is potentially quite a bit of utility beyond, particularly with regard to emapalumab.

Synagis, we obviously want to further improve our value chain and basically ensure that we have the correct dosing cycle reducing leakage. And obviously, we are quite gratified that we can further internationalize our business into relevant markets, such as Japan and China for the rare disease player like us.

And basically, with this having said, as you can see, we have a lot of very positive data points in -- from the business in Q1. We are quite bullish about our business.

But given the uncertainty of today's environment, we didn't think it was appropriate at this time to increase guidance. And that's the reason why we stick to the guidance and focus on the business and to keep driving this.

And obviously, our ambition, let's say, remains unchanged. We want to drive double-digit growth in our two core businesses, Haematology and Immunology.

And our earnings forecast -- or earning guidance stays the same, and we still believe that with emapalumab and Doptelet, we have products in our hand that will make a very significant difference to the group over the years to come. And yes, with -- basically with this having said, I think we are open to questions.

I'm sorry for this little technical glitch.

Thank you. I have a few questions.

One on haemophilia. So for the first quarter of this year and now, have you seen some extra buying of haemophilia products because of the pandemic?

And also, are you seeing any impact from Hemlibra yet? And second question is on Doptelet.

I think you -- on the slide about 400 patients on the drug, I'm assuming it's commercial patients. Where these patients come from?

Are they switching from other TPO mimetics or are they new patients? And the last question is on COVID-19 trial.

Recently, Regeneron's IL-6 data doesn't seem very promising. So when you look at your current trial, assessing Gamifant as well as Kineret, do you have any view whether Gamifant could be more efficacious than Kineret?

Thank you.

Yes. Thank you, Eun.

Maybe I start off and then hand over to Milan later for the COVID-19 trial. With regard to haemophilia, I think what we have seen is -- I mean, given this is not accurate signs, but magnitudenally, probably around two-third demand, one-third is stocking effect or basically an effect where we make product available for patients who want to secure supply, and so there is an effect.

But as Henrik pointed out, it's not the majority of effect. So the products are doing quite well, and we keep seeing conversions of patients even in the virtual environment, which is quite gratifying.

So did we see an impact of Hemlibra? Yes, I mean, they are obviously a factor there, but I think they are probably more focusing or their current conversion is probably more from other products.

And let's say, the -- for us, let's say, we are focusing, obviously, on the benefits of our products. And hence, we enable the patients now with Florio, with this digital solution, to really manage the disease, don't have to worry too much about compromises in terms of safety or side effects and having liberating their lives.

So this is our story. So we haven't really seen any material effect here on our business.

With regard to Doptelet, yes, this is basically we -- I mean, it's quite difficult for us to see really the -- we have, I would say, a significant chunk are switches from other TPOs. We're really focusing on the TPO market alone, and this market is large enough for us.

And there are some new patients. But to quantify, this is -- I think we -- is currently not -- we don't have this granularity of data.

Probably, we'll look into this in the -- as part of the Q2, but it's quite nice to see that the product is actually considered relevant and there is an uptake. With regard to COVID-19, maybe, Milan, you want to share your thoughts on the efficacy, yes.

Absolutely, and thanks for your questions. So I think we, as a company, are sort of affected also by the COVID pandemic and wanted to do as much as we could for the community, and it was on that basis that we also initiated the trial in Italy, also as a response to the Italian government.

And I think it's too early to say whether we -- what that trial would have as a readout. But what I can say is that we have seen some similarities between the HLH phenotype and some of the characteristics that we see in the patients that are most severely affected by COVID-19.

So these hyper-inflammatory characteristics and this -- the unperpetuated activation of the immune system. So we think there is potential to study emapalumab in this disease, but I think it's too early to say what the readout would look like.

Thank you.

Thank you.

Hi, there. So congrats on a good quarter, obviously.

My first question is about the timing of the shift to higher royalty rate from Sanofi, lower rate to them from you guys on Elocta and Alprolix, what can you -- when should we expect that for both products? And then what kind of a discount did you have to offer in Saudi Arabia to convert the entire market?

And, I guess, last on haemophilia would be with BIVV002, it was not listed on your slide, obviously, it's a preclinical out there on Slide 21, it wasn't showing that. But can you give us any update on that?

Yes. Maybe on the royalty.

Henrik, do you want to comment?

Yes, sorry. Yes, but that is at the time of launch of BIVV001.

Yes, I think that we are not increasing our royalty now this year for Elocta. I think that the royalties will increase when we have the BIVV launch, but that's still a few years ahead.

I thought they shift from 7% to 12% when you pay off the debt for the development of Elocta?

No, that is not the case.

Okay. Sorry about that.

Yes. And with regard to discounts in Saudi Arabia, I think we were quite gratified that in Saudi Arabia people were thinking that there's a high utility obviously of extended half-life products versus other therapies and newer therapies.

And actually, there was not so much commercial stretch necessary. So the -- this was mostly done on the strength of the product profile.

And maybe with regard to the other question, Milan, do you want to come back to this?

Absolutely. So with regards to BIVV002, correctly, it's in the preclinical phase and that's why we don't include it in our pipeline slide.

We will give an update when and if it progresses. It is correct that it's for haemophilia B.

So it's a -- you could say, it's a factor IX-based product, but it's too early to include it in the pipeline slide because it's -- we have set the lens to Phase I and onwards.

Okay. And then on Doptelet.

So when should we actually expect top line for the CIT study? I mean, can you guide to that?

And then can you also talk about the rationale for doing a pivotal trial without survival as an endpoint?

Milan?

Yes. So with regards to the CIT trial, enrollment is progressing well.

We have just over 100 patients enrolled. So we are on track towards delivering top line results in the second half of 2020.

As we discussed, I think also on previous call, the primary endpoint was agreed with the FDA. It is a composite endpoint, and it is not different from another compound in this class.

So this -- the primary endpoint that we are starting has been agreed with the FDA. It is a composite endpoint, and it is not different from another compound in this class.

So this is a primary endpoint that we are starting has been agreed with the FDA.

Okay. Thanks.

And lastly, then so for now on treating cytokine release syndrome in COVID-19, so Gamifant and Kineret trials in Italy, I guess, obviously, the epidemic there is receding. So is there a risk that the trial will not be able to fully accrue similarly to the remdesivir in China?

And can you just comment on the timing of the planned CRS trial that was mentioned in the report? And, I guess, lastly would be, so yes, into -- tocilizumab has read out positively in RCT.

Can you perhaps give us some guidance around where we might see Gamifant fitting into and for that matter, Kineret, fitting into the treatment algorithm for severe COVID?

Yes. It's Milan here.

Yes, go ahead. Yes, so maybe if I start with the Italian Phase II trial.

So at this point in time, we have enrolled 80 [ph] patients out of the 54 patients. We have four sites in Italy.

We plan to enable more sites, and we may even go outside. I think you're right in the sense that the pandemic is decreasing, which is good, you can say, for the population as such.

And I think what we are doing now is we are finding the sites where we can see the right population. So actually, for us, we are less -- the lens that we have applied in our trial is we want patients with hyper-inflammation, but we don't want patients that are already mechanically ventilated.

So I think there will be a switch in the population, but we see that we will be able to fulfill enrollment of the trial, and we have said that we expect to be able to have top line results in Q3 this year. I think when it comes to tocilizumab, I think I will probably answer the same way as I just did.

I think we see some encouraging similarities in the underlying biology between what is being seen in these COVID-19 patients with severe respiratory distress. That gives us reason to hope that this looks similar to HLH and emapalumab, but it's too early to comment on what role either anakinra or emapalumab would play.

We have seen quite a lot of interest in anakinra in the medical community, and I think that's also reflected in the numbers. And anakinra is also included in a number of ISS studies that are ongoing right now.

Okay. Thank very much.

I'll get back in queue.

Thank you.

It's Peter from Handelsbanken. Thank you for taking my questions.

I had a few with respect to the pricing of Gamifant with [Indiscernible]. And you also said at the same time that the quarter-on-quarter increase patients both for Gamifant.

Do we see this as sort of a new novel in terms to revenues to in terms of lowering our price assumptions? Or could you just give us some hints as to how we should understand your comments regarding these patient volumes and/or cost because so far, the volatility has been as due to limited patient numbers, but also the high variation due to the weight dosing.

So just to give us some...?

Yes, absolutely. I mean, basically, if you would have the same weight of patients like in Q4, we would have seen a significant increase versus Q4 despite of the -- let's say, despite the price decrease.

I mean, the price decrease essentially is in the magnitude -- is a little bit lower than what basically we have had as a volume increase. But the key driver was here that we have had lighter younger patients.

And basically, the -- for us now -- and this is basically -- just come back to the Slide 17, I think that explains, basically, there's a -- for us, the price is now, say -- to say it, how can we reposition the product to a target population, which is essentially tenfold where we are today. And that's the reason why we had made -- had some concessions.

And basically, now trying to appeal to this larger audience. And we are now in the transition.

Obviously, COVID doesn't help. But even in the situation, what I wanted to say is we have -- excuse me, we have increased patient numbers quite considerably.

So for us now, the key is really with our medical team, and we have made some changes there to really propel growth towards this larger indication and make a significant impact there. And then I think you will not see this volatility as much anymore because when you are fishing in a pond of 100, 150 patients, let's say, 150, that is -- you can have different bias.

And we obviously -- this is obviously influencing this. So -- but if you are able to get a significant share of 1,300 patients, yes, then, obviously, the product will gain relatively quickly in terms of materiality, and this is what we are currently working on.

So I hope that in the second half that we will get to a more -- you will see the -- this effect of a lot of medical work, obviously, in the community, and providing clarity on the data and that this will yield the right results. The opportunity for the product is very significant here.

And it's -- so there's -- it is basically, we are now in the in between situation, but we want to enable this broader patient pool and then, obviously, relatively quickly then broaden it further with MAS and sJIA. And then obviously, hope to see already Europe approval by end of year or before end of year and then also go into the other geographies.

So that basically then -- we should then get into this more upward spiral.

Okay. Thank you.

I just have a couple of additional questions before I jump into the line. In terms of -- staying on Gamifant, I believe it was alongside the Q4 report you mentioned some interim data in macrophage activation symptom study where you saw good responses in six patients.

Could you give us an update there? And then I have a question for Henrik after that.

Yes. Milan, you want to comment on the MAS/sJIA trial?

Yes. So absolutely.

So we continue to be encouraged by the evidence that we get out of the macrophage activation syndrome trial secondary to juvenile idiopathic arthritis. And once we have all data from the 14 patients that we have enrolled, we plan to meet with the FDA and discuss what could the next steps forward be, including a potential indication.

So we continue to be encouraged by the evidence with emapalumab here.

Okay. Thank you.

So my question for, Henrik, is this, looking at the -- I'm just trying to understand the underlying cost development. Looking at your cost development in Q1 of last year and just looking at costs, excluding depreciation amortization, I see an increase of around SEK380 million compared to Q1 and you had some acquisitions since then to use it, but could you just give me a little flavor on this increase of SEK381 million in total OpEx, excluding depreciation and amortization, decomposing that and how much comes from the Dova acquisition, how much of this is related to SG&A, et cetera, et cetera?

Just to get a feeling for how we should model this for the rest of this year. Potentially also going into next [Indiscernible].

Henrik?

Sorry, I was on mute. Peter, thank you for the question.

Well, if you're comparing Q1 with the Q1 last year, I mean, obviously, we are comparing slightly different businesses because, first of all, we have full quarter of Synagis, which is a major product during the season, and then we also have the consolidation of Dova where we are in launch phase and where we are running clinical trials. So it's difficult.

It's almost two different animals. But if you look at Q1 and you compare it more with Q4, you see that it's actually a similar level.

Having said that, we don't guide on a quarterly basis, but our OpEx base is likely to increase slightly in the quarters to come.

Yes, I guess that's also, I guess, what is anticipated. My sort of -- what I'm trying to get at is you are mentioning that you have great opportunities with Gamifant and whether this also implies substantially higher costs than we currently anticipate to generate those opportunities?

Yes. Now maybe to help you further, if I repeat what we've said about Doptelet and how that will impact us, we said that Doptelet would impact our earnings by about minus SEK500 million during 2020, and that still stands.

Perfect. Thank you very much.

I'll jump back in queue.

Thank you.

Hi, Johan.

Thank you for taking my question. Yes, the understanding or the impression we get is that in rest, especially, I guess, these, to some extent already used them among severe COVID patients.

Is that correct? Of course, they have very few alternatives medically.

Yes. No, that's correct.

Yes, it is used, let's say, by physicians upon their own decision, obviously. Yes.

Because when you have these patients about to enter the ICU, you have to make some choices. And given the role of Interlukin-L1, so there are quite a few choices made in favor of Kineret.

Thanks. That's helpful.

And even if at this stage, it would be very anecdotal and not subject to any statistical relevance, but do you have any sort of flavor or feedback from that use?

I think we have -- we hear positive feedback. And -- but the proof is obviously in readouts of studies.

And we think that there will be quite a bit of data for Kineret, in particular coming up within the next couple of months.

Thank you. That's all.

Hi, and thank you for taking my question. So do you see any different prescribing patterns among physicians that are prescribing Synagis in the COVID-19 pandemic?

Maybe that they prescribe that product more to protect patients? Or how do you think we should view this strong sales in Q1 and how to extrapolate that going forward?

Thank you.

Yes. I think the Q1 data are influenced by the fact that our hub that we had in place started working much better in Q1 even than Q4.

So basically, we were able to improve compliance on the prescribed dosing scheme because we -- there was always an issue that patients would not get -- takes a full cycle. And also what basically COVID has helped is that basically people don't want to make -- take any chances to protect the preterm babies or the compromised babies.

And I think that helps here, but I think it's primarily really the job of the team that really shaped up in Q1. And yes, and basically, was able to work on some of these inefficiencies in the chain.

But I don't -- I'm not aware that the product is used for COVID-related indications.

Yes. And on Doptelet also, the trajectory in the U.S.

is still quite flat, but how do you see that going forward in 2020? When do you expect a larger adoption of that product and more switches going forward?

I think what we realize is the product was a little bit held back by some of the transition period on CLD. So we had a bit of more decline on CLD.

Actually, the patient acquisition in ITP is quite positive. I think in the moment we -- our teams can have a direct face-to-face interaction again, which is now partially opening up, you will see material increases because we have seen that basically -- once we basically get really started on this, the product is responding well.

So it is -- and we are now doing some other programs that basically are more in line through today's access realities and let's see whether they bear fruits already. But I think the real impact, you will see already when we have the team again in the field because the product has distinct advantages as we have discussed.

And it will make -- it will find its way. And I'm not -- honestly, I think will -- for the -- in this environment, I think the first quarter was a decent quarter.

And I think -- we think that we can do better in Q2.

Thank you. And just a final question.

So you have some clinical trials now in Phase III, such as BIVV001, nirsevimab and CIT for Doptelet. Have you seen any impact on these trials due to the COVID-19 pandemic?

Or could you give any update on recruitment for these studies? Thank you.

I think maybe we start with the CIT trial. Milan has pointed out, we have well above some 100.

We have now the first patient also coming in out of China. That basically makes us quite hopeful that we can deliver the goods in line with the time line that we have outlined.

With regard to BIVV001, Milan, do you want to comment? But I don't think we have any indications yet, but maybe you want to give a perspective.

Yes. So I think with the CIT trial, we have all sites up, and it's going well, and we have just enrolled about 100 patients, and we are on track towards delivering the results in second half.

I think when it comes to BIVV001, we have a few patients enrolled. It's too early to say whether there would be an impact of COVID.

We have seen a decreased ability to initiate sites. But I think it's too early to say whether this would have an impact on time lines.

Okay. Thank you very much.

That's all from me.

You're welcome. Thank you.

Appreciate it.

Yes. Hello.

I was wondering a little bit about the stocking effect. If you could tell me the magnitude of the stocking effect in the Q1.

Could it possibly be quantified as well? Also, I was wondering about the Florio.

Could you tell me a little bit about the revenue model behind it? And what do you see the potential for it?

Thank you. Maybe we start with the stocking effect.

Henrik, do you want to give it a little bit more color?

Yes. Sure.

When it comes to stocking, we have observed stocking almost exclusively in the haemophilia product. So not really any measurable outside of that.

We see that it's about one-third to 40% of the Elocta growth that we'll be stocking, which means that the major part of the growth compared to previous quarters is really demand growth.

Yes. And so I think..

And, in the case of Alprolix, it's similar that it's only a minor part which is stocking.

So maybe we -- and I give you some color on Florio. So Florio is a platform where -- which basically allows the patient to see quite a few parameters coming that he inputs and basically that cover different areas of well-being.

And -- but also combines it with individualized PK profile. So essentially, the patient can see at any given point of time what his factor activity level is.

And this basically means that the patient knows, if I want to play soccer now, then I need to have a certain activity level in order to avoid bleeding. So this -- and this is basically fully enabled for different devices like an iWatch or a mobile phone.

And basically, the revenue model, I mean, we have -- we make this available to the community. There is no for us, we believe that's the best product, and we think that this is Elocta and Alprolix, that they will benefit from this simply because they -- of the advantageous profile.

And that basically, patients will want to be basically know how they can actively live, let's say, manage their life and not believe that they are healthy and then start bleeding because they're thinking of it's so convenient to get maybe once a week subcut but not realizing that their activity level is not high enough to cover -- the factor activity level to cover more active life. So that's basically the thought process behind this.

And we think that this will pay dividends, and you will see the, hopefully, the payback and via increased revenues in our core product.

Very well. Thank you.

You're welcome.

Hi. Thanks for taking question.

I only have one on the Doptelet Phase III study in CIT. Can you just remind us of any trial design or patient recruitment differences versus the Promacta trials that you think would favor a positive outcome in H2?

Thank you.

Sure. I mean, Milan, you want to take it?

Yes. So I think we are quite comfortable with the CIT indication with avatrombopag.

I think there is a wealth of data that supports a TPO agonist to increase platelet counts in patients that are undergoing chemotherapy-induced or have chemotherapy-induced thrombocytopenia. We have taken the learnings from the other programs and implemented that into our program.

As we discussed before, we have a composite primary endpoint that, I think, is clinically meaningful and that has been agreed with the FDA, which essentially is proportion of subjects who do not require platelet transfusion, who do not require dose reduction and who does not have to have a chemotherapy delay. So -- and our patients essentially they have to go through one cycle where we document that they have low platelet counts and this is when we initiate treatment.

So we think this trial has been optimized in order to show an effective avatrombopag, but also something that is clinically meaningful for the patients and the medical community.

Great. Thanks very much.

You're welcome. Yes.

So basically, what you can see in summary maybe is that the business is performing well. On the key endpoints that we are driving, we think that we can make substantial progress.

Hence, we think that we are very well equipped for the rest of the year. Any other questions?

If not, then I would like to close this conference call. Really appreciate your interest in Sobi, and wish you a great day, yes.

Talk to you soon. Bye.