Yeah. Welcome everybody. It's really a great pleasure to have you here on the Sobi call, knowing that we are competing with quite a few other earning calls. I go right into it. We'll start with a forward-looking statement as per usual. Please take note 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. With this having said, these are obviously unprecedented times. I go to slide number four. Very challenging times. Before we talk about our very significant top and bottom line growth, just wanted to tell you that we absolutely take the situation very seriously and take charge. For us, the first priority was to make sure that patients requiring any of our products get access to, and we have achieved this.
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 measures at an early stage in terms of virtuality of our office environment and also travel restrictions. We also want to make sure that we are staying in contact with our HCPs in a proper way and make sure that we respect, obviously, their priorities of today, but also make sure they understand that we do care. In addition, we have been able to launch 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 are as few compromises for hemophilia patients as possible. I think this was an important strategic move for the group.
And we have expanded our footprint internationally with China, and we are on the way to do the same in Japan. This bolsters by a very strong financial profile that Henrik is going to explain further this part. With this having said, what are the results? I think you have headline results, 42% growth on the top line, 44% earning growth. Pretty strong results. 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 at constant currency with Kineret, driven by COVID-related indications of the hyperinflammation as a result of the COVID-19 infection. We had spectacular growth with Synagis, so we ended the season very strongly and have been able to confirm our Q4 results with Synagis. The product has performed extremely well under our ownership.
With Gamifant, I think it is important to note that we had 17% at actual currency, 11% at constant. We had a strong quarter patient growth. Please remember that the Q4 results were very strong of 21% patient growth. This 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, I am very happy that we have been growing to drive this franchise at 30%. Obviously, driven by our hemophilia products, and I will come back to in the later part of the presentation. We made our first strides with Doptelet. Basically, when you think about on page six how the group is developing, basically what we have told you in the past is happening now and justified by our results.
The two core businesses have really grown exponentially, and immunology has become an important second pillar in this franchise. That's very gratifying that basically our strategy is yielding the results. When you go to the next slide on page seven, basically, if you summarize this, we still have the appetite to grow haemophilia, and we see the positive momentum to do so. I will talk about some of the nuggets in a few moments. We have launched Florio, just one example. With Doptelet, we have made our first imprint, the first 450 patients in ITP. Not insignificant already the impact in a very difficult environment. CLD, we are planning for launching in the EU and we got recently also the CLD indication approved in China.
Basically, when you come then to 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 trials that are currently ongoing and the clinical activities with Gamifant and also with Kineret. Obviously, for us, it's important that we continue driving Synagis. Basically, what we want to leave you with these challenging times really stimulate our appetite to do more and to do 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 are staying connected to our key customers and think about new tools and new ways of interacting with our customers. Staying true to our values, whether about ambition, about urgency, ownership, but also about care.
With this having said, I go straight to the hematology business review on page 10. As you have seen on the report already, the hematology business has been doing extremely well. I just wanted to bring a little bit alive the first data points for Doptelet to SEK 65 million in the Q1 was quite gratifying for us. Particularly as we were the transition on the CLD indications in the U.S. to transition out of Cellerix and taking charge ourselves. We think that with Doptelet we made the first impact. Obviously, it's not easy to launch a product in a more virtual access model, but we believe that we will have a stronger Q2 and be finally adjusting our commercial model accordingly. Going into the hemophilia products at 11.
Elocta has made significant strides in the growth countries that it's coming from is Spain, is CE. It's also 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 gains. And Henrik will talk more about this. Let's say there is a supply chain effect, but this is a minority part of these gains. With regard to Alprolix, also here it's a very strong demand growth. This continues in key markets. It's quite nice to see that we have got Spain approved. With this having said, I just want to have a couple of words on our digital platform called Florio.
As you can see here, this is a fully integrated platform that allows patients to basically know exactly what they can do at one given point of times and how they can adjust their life and basically are in a position to have a very active life. Manage their disease as opposed to forget about it. And on top, we are connecting the patient to physician. We feel that this 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 think it will be very useful for the patient community. Coming to immunology. As you can see here on page number 14, the immunology business has benefited from a fantastic season with Synagis. Significant uplift. And the product is really performing well.
We had some initial topics with the supply chain. We are now in the process to fix those and be even stronger for the next season. And so for us this was a fantastic acquisition and supported this strong organic growth. Kineret also for Gamifant. Overall, the franchise has performed very well. When you come to Kineret the good news is we keep growing our existing business very well. This positive CHMP opinion for special indication called familial Mediterranean fever. Basically, our original, let's say, strategy to build this business based on rare disease indication we continue. Now basically we got on top the opportunity in the COVID-19 pandemic.
And here the opportunity in the hyperinflammation rhinosinusitis and already a few thousand patients have been treated and the product is in clinical research cooperation is 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. What we can say is there's a compelling evidence that interferon gamma contributes to clinical conditions seen in HLH patients. There's a 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 in sJIA study enrollment has been completed. So we are on track with the study, very gratified that we were able to do so.
The secondary HLH adult patient study has been opened for enrollment and we are also preparing the graft failure study. 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 a significant role in the cytokine storm syndrome. This led us to believe that we should study this, and this we have been doing or we are doing currently in the Italian trial that Milan will talk about later. 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 it covers in the U.S. a broader patient pool, and we are trying very hard to enable this move.
And then basically the 21% patient growth versus Q4 is the first proof point of this endeavor. 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 expect to submit before end of year. And basically then we will take this franchise internationally with these indications into Europe, Japan, and China, followed by other indications that will open up the product. So we are very happy that we have this product. This is in a very exciting compound. We are obviously now with the potential utility in COVID-19 induced cytokine storm syndrome. We are on the way to show additional utility.
That's the reason why this is more of an illustrative example that build upon what we have already announced. We think that we may be able to do more for this product and would like to update you in due course. 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. Hello, everyone. On this slide, we are illustrating the role of the cytokine storm syndrome within patients with severe COVID-19 infection. As you're probably well aware of, there's accumulating evidence now indicating that hyperinflammation 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 morbidity and also the mortality of the disease. What we find is that this disease has some characteristics that are similar to what we are seeing in HLH, including the elevated cytokines. If I can have the next slide, please.
This is what we are 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-one and interferon gamma. 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 care in patients with known hyperinflammation and with a high risk of requiring ICU admission and also mechanical intervention. 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. 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 hematology and immunology. We have two ongoing Phase III studies, one with BIVV001 in collaboration with Sanofi, and one for avatrombopag in chemotherapy-induced thrombocytopenia. We have the Phase II/III study with emapalumab in adults with non-primary 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 a favorable opinion from CHMP for familial Mediterranean fever with anakinra.
We have the chronic immune thrombocytopenia application with avatrombopag under review in Europe. We plan to also submit to FDA the indication DIRA or deficiency of the interleukin-one receptor antagonist in the U.S. in 2020. So in addition to that, we have the option for the immuno-oncology 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. All in all, we have a very strong pipeline, I think with the potential to really keep the company growing also into the future. With that, I want to hand over to Henrik for the financial results.
Thank you, Milan, good afternoon, everyone. Let's start with the revenue bridge since Q1 2019. Revenues for Q1 amounted to SEK 4.639 billion. That corresponded to an increase of 42% and 37% at constant currencies. SEK 179 million of the reported number was related to the impact from positive FX movements. Our hematology franchise, consisting of hemophilia and Doptelet, was the largest contributor to growth with SEK 588 million, an increase of 34% at CER. Elocta and Alprolix both showed strong growth, 33% and 41% at CER respectively. This growth was mainly driven by continued patient growth but was also impacted by increased stocking due to the uncertainty of COVID. For clarity, outside of hematology, we saw only limited stocking impact during the quarter. Furthermore, we also saw first full quarter of Doptelet sales with reported revenue of SEK 65 million.
In immunology, we saw Synagis sales of SEK 1,196,000 corresponding to a growth of SEK 471 million at CER year-on-year. 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. 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 SEK 312 million from Q3 to this quarter. We do not expect any material sales in Q2, this is anyway a double-digit growth compared to the previous season. Kineret sales for the quarter were SEK 501 million, an increase of 39% at CER.
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 SEK 104 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 SEK 445 million. As we mentioned in Q4, we expect specialty care to decline by SEK 300 million to SEK 400 million in 2020 compared to 2019 as we are discontinuing various products now. If we go to next slide, please. Move on from the revenue, we saw a gross margin of 78% in Q1 compared to 76% in Q1 2019. Due to the seasonal product mix effect, primarily driven by Synairgen's gross margin will likely be slightly lower in Q2 and Q3.
The adjusted EBITDA number reached SEK 2,173,000 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. And to the adjusted EPS, adjusted for non-recurring items for the quarter was up 32%. Furthermore, operating cash flow of SEK 2 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 SEK 15.4 billion at the end of last year to SEK 14.2 billion at the end of this quarter, which we will now take a look at on next slide, please. I return to the development of net debt per quarter. In 2019, we completed the acquisitions of Synagis, Semoparm and Adova.
And with that, we levered up to a net debt of SEK 15.4 billion. In Q1, we reduced net debt by SEK 1.2 billion due to the strong operating cash flow of SEK 2 billion, partially offset by the currency effects from our debt, EUR and USD. At the end of Q1, this gives us a pro forma leverage of well below two point five times and an available liquidity of about SEK 7 billion, which provides us with opportunities going forward. If we go to the next slide, please. Finally, I wanted to give a perspective of where we stand with our business during COVID-19 times. And this relates to what we've seen in Q1, and we are, of course, aware of the considerable 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. Next, thanks to our technical operations team and our partners, we continue to be able to supply product to our customers. Furthermore, our strong cash flow relies on receipts 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 SEK 7 billion, which provides not only a safety net for our business, but also continue to invest in our business and to look for new business opportunities. With that, I say thank you and back to Guido again.
Yes. Sorry, we have a technical glitch here. But I just wanted to share with you that just to summarize, we have an appetite to further expand our position in hemophilia. 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 % growth of patient growth versus Q4 and Q1 for both products. This just showed that we are still relevant and we have a fantastic team to drive growth in this area. With our Doptelet, we are obviously super excited to drive the product into the new indication here, promo CIT. We have over 100 patients now recruited or enrolled in the study, 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.
We think that this is going to be a significant product for us. With regard to immunology, as we explained, we have anakinra and emapalumab now in COVID-19-related hyperinflammation studies in the pivotal environment. We have also quite numerous research collaborations that we would like to update you on this during the Q2. We think that there's potentially quite a bit of utility beyond, particularly with regard to emapalumab. Synergies, we obviously want to further improve our value chain and basically ensure that we have the correct dosing cycle, reducing leakage. Obviously we're quite gratified that we can further internationalize our business into relevant markets such as Japan and China for a rare disease player like us. And basically with this having said, as you can see, we have a lot of very positive data points from the business in Q1.
We are quite bullish for business, given the uncertainty of today's environment, we didn't think it was appropriate at this time to increase the guidance. And that's the reason why we stick to the guidance and focus on the business and to keep driving this. Obviously our ambition remains unchanged. We want to drive double-digit growth in our two core businesses, hematology and immunology. And our earning forecast or earning guidance stays the same. And we still believe that with emapalumab and Doptelet, we have a product in our hand that will make a very significant difference to the group over the years to come. With this having said, I think we are open to questions.
Thank you.
I'm sorry for this little technical glitch.
Thank you. If you have a question for the speaker, please press zero one on your telephone keypad. The first question comes from the line of Eun Yang from Jefferies. Please go.
Thank you. I have a few questions. One on hemophilia. For the Q1 of this year and now, have you seen some extra buying of hemophilia products because of the COVID-19 pandemic? And also are you seeing any impact from Hemlibra yet? Second question is on Doptelet. I think on the slide about 400 patients are 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-six data doesn't seem very promising. 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.
Thank you, Eun. Maybe I start off and then hand over to Milan later for the COVID-19 trial. With regard to hemophilia, I think what we have seen is, given this is not accurate science, but magnitudinally. Probably around two-third demand. One-third is the stocking effect or basically an effect where we make product available for patients who want to secure supply. 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. Did we see an impact of Hemlibra? They are obviously a factor, and they are there, but I think they are probably more focusing or their current conversion is probably more from other products.
And let's say for us, we are focusing obviously on the benefits of our products. Hence, we enable patients now with this Florio, with this digital solution, to really manage their disease, don't have to worry so much about compromises in terms of safety or side effects and liberating their lives. This is our story. We haven't really seen any material effect here on our business. With regard to Doptelet, yes, it's quite difficult for us to see really the pro we have, I would say a significant chunk are switchers from other TPOs, really focusing on the TPO market alone. This market is large enough for us. And then there are some new patients, but to quantify this, I think we don't have this granularity of data and probably we'll look into this as part of the Q2.
It's quite nice to see that the product is actually considered relevant and that there's an uptake. With regard to COVID-19, maybe Milan, you want to share your thoughts?
Absolutely
on the efficacy? Yeah.
Absolutely. Thanks for your question. I think we, as a company, sort of affected also by the COVID pandemic and wanted to do as much as we could for the community. It was on that basis that we also initiated the trial in Italy also as a response to the Italian government. I think it's too early to say what that trial would have as a readout. What I can say is that we have seen some similarities between the HLH genotype and some of the characteristics that we see in patients that are most severely affected by COVID-19. These hyperinflammatory characteristics and this unperpetrated activation of the immune system. We think there is potential to study in the development of this disease, but I think it's too early to say what the readout would look like.
Thank you.
Thank you.
The next question comes from the line of Christopher Uhde from SEB. Please go ahead.
Hi there. Congrats on a good quarter, obviously. My first question is about the timing of the shift to higher royalty rate from the lower rate to them from you guys on Elocta and Alprolix. When should we expect for both products? What kind of a discount did you have to offer in Saudi Arabia to convert the entire market? I guess last on hemophilia would be with BIVV002. It was not listed on your slide. Obviously, preclinical there on the 2021 wasn't showing that. Can you give us any update on that?
Yeah. Maybe on the royalty, Henrik, you want to comment?
Yeah, sorry. Yeah, but that is at the time of launch of BIVV001.
Yeah. I think we are not increasing our royalty now. Yeah. I think that the royalties will increase when we have the BIV launch, but that's still a few years ahead.
I thought they shift from seven to 12% when you pay off the debt for the development of Elocta.
No, that is not the case.
Sorry about that.
Yeah. With regard to discounts in Saudi Arabia, I think we were quite gratified that in Saudi Arabia, people were thinking that there is a high utility obviously of extended half-life products versus other therapies with newer therapies. Actually, there was not a commercial stretch necessary. But it was mostly done on the strength of the product profile. And maybe with regard to the other question, Milan, you want to come back to this?
Absolutely. With regard to BIVV002, correctly, it's in the preclinical phase, and that's why we don't put it in our pipeline slide. We will give an update when and if it progress. It is correct that it's for hemophilia B, it's a specific factor IX phase for this II/III included in the pipeline slide because we have set the lens to Phase I and onwards.
Okay, thanks. On Doptelet. When should we actually expect top line for the CIT study? Can you guide to that? Can you also talk about the rationale for doing a pivotal trial without survival as an endpoint?
Milan?
With regards to the CIT trial, enrollment is progressing well. We have just over 100 patients enrolled. We are on track towards delivering top line results in the H2 of 2020. As we discussed, I think also at a previous call, the primary endpoint was agreed with the FDA. It is a composite endpoint. It is not different from another compound in this class. The primary endpoint that we are studying has been agreed with the FDA.
Okay, thanks. Lastly, for now on treating cytokine release syndrome in COVID-19. Uh so Gamifant and Kineret trials in Italy, I guess obviously the epidemic there is receding, is there a risk that the trial will not be able to fully accrue similarly to the remdesivir in China? And can you comment on the timing of the planned CRS trial that was mentioned in the report? I guess lastly would be, 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-19?
Yeah.
Milan?
Yeah, go ahead. Yeah. Maybe if I start with the Italian Phase II trial. At this point in time, we have enrolled 80 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 are right in the sense that the pandemic is decreasing, which is good, you can say, for the population as such. I think what we are doing now is we are finding the sites where we can see the right population. Actually for us, the lens that we have applied in our trial is we want patients with hyperinflammation, but we don't want patients that are already mechanically ventilated.
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 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 could 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.
anakinra is also included in a number of ISS studies that are ongoing right now.
Okay, thanks very much. I'll get back in the queue.
Thank you.
The next question comes from the line of Peter Sehested from Handelsbanken. Please go ahead.
Yeah, it's Peter from Handelsbanken, thank you for taking my question. I had a few. Back to the pricing of Gamifant with patients. You also said at the same time that quarter-over-quarter increase patients growth Gamifant. Should we see this as sort of a new normal in terms to revenues, in terms of lowering our price assumption, or could you just give us some hints as to how we should understand your comments regarding these patient volumes and low cost? So far the volatility has been due to the limited patient numbers, but also the high variation-
Yeah
Due to the weight dosing.So just give us some details.
Yeah, absolutely. I mean, basically, you know, if you would have had the same weight of patients like in Q4, we would have seen a significant increase versus Q4 despite the price decrease. The price decrease essentially is in the magnitude, is a little bit lower than what we have had as a volume increase. But the key driver was here that we have had lighter or younger patients for us now, this is to come back to the slide 17. I think that explains, for us the price is now to say how can we reposition the product to a population which is essentially 10-fold where we are today. That's the reason why we had some concessions now trying to appeal to this larger audience. We are now in the transition.
Obviously, COVID doesn't help, but even in this situation, what I wanted to say is we have increased patient numbers quite considerably. For us now, the key is really with our medical team, and we have made some changes there to really propel growth towards this large 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, you can have different bias. This is obviously influencing this. If you are able to get a significant share of 1,300 patients, then obviously the product will gain relatively quickly in terms of materiality, and this is what we are currently working on. I hope that in the H2 , you will see 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. But on the opportunity for the product is very significant.
It is basically we are now in this 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 approved by end of year or before end of year, and then also go into the other geographies. That basically then should 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 the macrophage activation syndrome study where you saw good responses in six patients. Could you give us an update there? I have a question for Henrik after that.
Yeah. Milan, you want to comment on the MAS sJIA trial?
Absolutely. We continue to be encouraged by the evidence that we get out of the macrophage activation syndrome trial secondary to juvenile idiopathic arthritis. 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. But we continue to be encouraged by the evidence with emapalumab here.
Okay, thank you. My question for Henrik is this, I'm just trying to understand the underlying cost development. Looking at your cost development in Q1 of last year, just looking at costs excluding depreciation amortization, I see an increase of around SEK 380 million compared to Q1. I've had some acquisitions since then, could you just give me a little flavor on this increase of SEK 381 million in total OpEx, excluding depreciation amortization, decomposing that in how much comes from the Dova acquisition, how much of this is related to SG&A, et cetera. Just to get a feeling for how I should model this for the rest of this year, potentially also going into next-
Henrik?
Sorry, I was on mute, Peter. Thank you for the question. Well, if you're comparing Q1 with Q1 last year, obviously we are comparing slightly different businesses because first of all, we have a full quarter of Synagis which is a major product during the season. Then we also have the consolidation of Dova, where we are in launch phase and where we are running clinical trials. It's difficult. It's almost two different animals. 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 likely in the quarters to come.
Yeah, I guess that's also what is expected. My sort of essentially what I'm trying to get at is you are mentioning that you have great opportunities with Gamifant. Whether this also implies substantially higher costs than we currently anticipate to generate those opportunities.
Yeah. 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 SEK 500 million during 2020, and that still stands.
Perfect. Thank you very much. I'll jump back in the queue.
Thank you.
Thank you.
The next question comes from the line of Johan Unnerus from Pareto Securities. Please go ahead.
Hi, Johan.
Thank you for taking my question. Yes. The understanding or the impression we get is that NRS, especially, I guess to some extent already used them among severe COVID-19 patients. Is that correct? Of course, they have very few alternatives medically.
Yeah. No, that's correct. Yeah. It is used, let's say, by physicians upon their own decision, obviously. Yeah. When you have these patients about to enter the ICU, you have to make some choices. And given the role of interleukin one, there are quite a few choices made in favor of Kineret.
Thanks. That's helpful. 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 hear positive feedback. And back on the proof is obviously in readouts of studies. 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.
You're welcome.
The next question comes from the line of Victor Sandstrom from ABG. Please go ahead.
Yeah. Hi. Thank you for taking my question.
Yes.
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 the strong sales in Q1 and how to extrapolate that going forward? Thank you.
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. Basically, we were able to improve compliance on the prescribed dosing scheme because there was always an issue that patients would not take the full cycle. And also what there COVID-19 has helped, is that basically people don't want to take any chances to protect their preterm babies or their 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 basically was able to work on some of these inefficiencies in the chain. I'm not aware that the product is used for COVID-19 related indication.
Yeah. Thank you. On Doptelet also, the trajectory in the U.S. is still quite flat. 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 realized is the product was a little bit held back by some of the transition period on CLD. We had a bit of a more decline on CLD. Actually, the patient acquisition in ITP is quite positive. I think in the moment our teams can have direct face-to-face interaction again which is now partially opening up, you will see a 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 you know, we are now doing some other programs that basically are more in line to 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 find its way.
Honestly, I think in this environment, I think the Q1 was a decent quarter. We think that we can do better in Q2. Yeah.
Thank you. Just a final question. 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? 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 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 timeline that we have outlined. With regard to BIVV001, Milan, you want to comment? I don't think we have any indications yet. Maybe you want to give a perspective.
I think with the CIT trial, we have all sites up and it's going well, we have just enrolled above 100 patients and we're on track towards delivering the results in the half. I think when it comes to BIVV001, we have a few patients enrolled. It's too early to say whether there will be an impact of COVID. We have seen a decreased ability to initiate sites, I think it's too early to say whether this will have an impact on timelines.
Okay. Thank you very much. That's all from me.
You're welcome. Thank you. Appreciate it.
The next question comes from the line of Magnus Bernet from Direkt. Please go ahead.
Yes, hello. I was wondering a little bit about the stocking effects. If you could tell me the magnitude of the stocking effects 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 you see the potential for it? Thanks.
Thank you. Maybe we start with the stocking effect. Henrik, you want to give it a little bit more color?
Sure. When it comes to stocking, we have observed stocking almost exclusively in the hemophilia products, so not really any measurable outside of that. We see that it's about one-third to 40% of the Elocta growth that will be stocking, which means that the major part of the growth compared to previous quarters is really demand growth.
Yeah.
In the case of Alprolix, it's similar that it's only a minor part which is stocking.
Maybe, and I give you some color on Florio. Florio is a platform, where this basically allows the patient to see quite a few parameters, coming that he inputs, and basically that cover different areas of well-being but also combines it with a individualized PK profile. But essentially, the patient can see at any given point of time what his factor activity level is. 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. This is basically fully enabled for different devices like an iWatch or a mobile phone. And basically the revenue model, we make this available to the community.
For us, we believe that the best product, and we think that this is Elocta and Alprolix, that they will benefit from this simply because of their advantageous profile and that basically patients will want to 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 think it's so convenient to get maybe a once a week subcut, but not realizing that their factor activity level is not high enough to cover the fact that activity level is high enough to cover a more active life. So lets say that's basically the thought process behind it, and we think that this will pay dividends. We will see hopefully the payback via increased revenues in our core products.
Very well. Thank you.
You're welcome.
The last question comes from the line of Brian Balchin from Barclays. Please go ahead.
Hi. Thanks for taking the 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. Milan, you want to take it?
Yeah. I think we're quite comfortable with the CIT indication with avatrombopag. I think there is a wealth of data that supports 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 do 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 effect of avatrombopag, but also something that is clinically meaningful for the patients and the medical community.
Great. Thank you very much.
You're welcome. Basically what you can see in summary maybe is that the business performing well on the key endpoints that we are driving. We think that we can make substantial progress. And we think that we are very 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. Wish you a great day. Talk to you soon. Bye.