Ladies and gentlemen, welcome to the Sobi presentation of the Q2 results. I will now hand over to Guido Oelkers, CEO, Henrik Stenqvist, CFO, and Milan Zdravkovic, Head of R&D. Please go ahead.
Yeah. Thank you so much. Good morning, everybody. It's really my pleasure to kick off our Q2, the result presentation. Let's go straight to slide three. The presenters, as mentioned, forward-looking statement, obviously, as per usual. The presenters today are myself, Henrik, CFO, and Milan, our Head of R&D. Quite blessed to present some what we believe are strong results. If you go straight onto page four. Basically, when you look at it, what are the main pieces? That's the reason why we call it strong performance, sharper focus. We think that we are presenting here today a very strong quarter result, financials as well. What we also let show is that we strengthen our organization, particularly in the United States, but also in other countries where we have invested into our business.
Hence, you don't see the operating leverage at the bottom line as much. Hence, we are building our future in R&D, particularly on the stage pipeline. We need to mention in this context our programs with emapalumab in particular. We focus also on what matters. That means that we sharpen our focus on our core areas in hematology and immunology, hematology out of Sweden, immunology out of Switzerland, that resulted into an alignment of our structure. When you think about it, bring the results now into context, 38% revenue growth in the quarter is quite strong.
What is gratifying here is that our hemophilia franchise with Elocta growing at 42 and Alprolix growing at 45, shows in a good way, we see strong patient uptake in hemophilia, demonstrating that what we are doing now with our Liberating Life campaign and also the focus behind those products and the clinical work is paying dividends. When you look at the financials, we have a 25% uplift on the EBITDA, demonstrating strong financial growth or earning growth. We are also investing into our future, and we believe that this is what you want us to do, to strengthen Sobi also in the years to come. For us, very gratifying in the immunology field was the uplift of Gamifant.
Even though it's early days, we felt that the SEK 205 million in Q2 demonstrates that we are entering an area with a very high unmet medical need in HLH. We got very positive feedback from numerous physicians who are using the product now. Very pleased with the uplift of Gamifant in Q2, that increases our confidence around the product and supports our decision to have acquired this product. We have also concluded or we have signed a purchase agreement with regard to emapalumab and related assets. We reported on this earlier. You know that we got an organization as part of this transaction and very proud of it. That is now the nucleus for our immunology franchise out of Switzerland. We think that this is an organization that can be leveraged in the future significantly.
We also got an option for two immuno-oncology assets, that we are also very pleased about. That really gives you a little bit of a flavor. It's really about today, strong financial performance. It's about building our organization, it's also building tomorrow. Now to go a little bit more into the meat of the presentation and show you a little bit on the next page, what we do by the different business areas. In hemophilia, as I mentioned, we think that we have a very strong momentum. We see strong penetration in existing markets. We accept that obviously, there's increased competition out there, we are convinced by and we are gratified by the products that we have, that these are really state-of-the-art products and that factor treatment is here to stay and remains the standard of care in this area.
We benefit from further internationalization, and we got some further first really nice uplift also in Eastern Europe. This shows that we believe our growth story has a couple of more legs. We see also that the concept of individualizing and intensifying therapy, and with this allowing patient to have a more normal life, that this also resonates because it is not about making patients forget about the disease, it is about improving outcome and allowing patients to live the life that they like to live. We feel that factor replacement plays an important role in this context. We believe that factor treatment will remain the standard of care.
When you see later the results that we published at ISTH on BIVV 001, we see that when we look at the areas under the curves that you can achieve with those newer treatments, we think that we have not by far reached the end of the life cycle for this treatment and that we will be part of the future in this regard as well. Now we go to the financials. As you can see, Alprolix doing extremely well. On a year-to-date basis, we have 66% growth. Now in the quarter, we are 45%. Growth is driven by France. In Germany, as depicted here, we have now a nice franchise of countries.
Basically, for us, the main theme is here to make sure that in factor IX, it is not just about trust, it is about the distribution of the product and Alprolix has demonstrated that in the clinical benefits in the extra vascularization. We were quite gratified to see in our recent publication that was published at ISTH, where Alprolix even showed zero bleeds, unlike other EHLs. This confirmed our view that Alprolix is really a fantastic product in the factor IX treatment, and more patients should benefit from it. Next slide. Maybe we go to our performance with Elocta. With Elocta, we had a very strong quarter as well, with 42% growth. Also here, no surprise, mainly driven by the main markets in Europe. Also very positively affected in the Middle East. We have now here very nice already distribution by countries in 27.
We think that, yes, there is a lot of noise in the hemophilia A market, but people also recognize in daily practice that factor treatment has an important role to play. Let me go maybe to the next slide, and I refer to Milan, who will share with you some exciting data that were recently published at ISTH.
Thanks, Guido. This slide shows the data from the completed single dose study with BIVV001 in patients with hemophilia A. Now, BIVV001 has been designed to have a half-life that is decoupled from the von Willebrand factor-mediated half-life ceiling. Hereby, not only prolonging the half-life, but also giving greater exposure, and thereby potentially also enabling better protection. As shown here on the slide, at the clinically relevant dose of 65 units per kilogram, the half-life of BIVV001 was 43 hours versus 13 hours for traditional recombinant human factor VIII. This was associated with factor VIII levels with BIVV001 of 38 and 17% after five and seven days, respectively. In addition, as can be seen from the figure, normal factor VIII levels were obtained in the first days after dosing with BIVV001.
In summary, these data supports that BIVV001 may have the opportunity to bring unprecedented protection and to liberate the lives of people with hemophilia A. If I can have the next slide. Immune tolerance induction is the standard of therapy for eradication of inhibitors, and there are experimental data and retrospective clinical data suggesting that there may be immunomodulatory effects and also favorable effects on ITI of Fc fused factor therapy. This slide shows the interim results from the prospective clinical study with Elocta for first-time ITI in subjects with severe hemophilia A and high titer inhibitors. What we saw was that in six out of 15 patients, we saw an ITI success after a median of 11.7 weeks, suggesting that Elocta may offer rapid time to tolerization.
While these data are early and not all patients have completed the study, the time to tolerization compares very favorably to the international ITI study. We are very encouraged by these interim data, and we look forward to sharing the full data set when it's available. Back over to you, Guido.
Thank you so much. Now it's time to talk about our other leg, main leg, which is immunology. As you have probably seen, very strong results, with all three products. I start with Kineret where we had now 24% growth in the quarter. This demonstrated that we were able to overcome some of the turbulences that we had with the distributor change and now reposition the product for growth. Gamifant, obviously, as I already alluded to at the beginning, very high unmet medical need, and this is propelling our growth in this sector. We are obviously continuously looking for opportunities to expand the franchise. We'll report back to you when it's the right time. Maybe we go into the meat of the presentation.
Here you can see the step change that we inflicted to our business with the acquisition of Synagis preliminarily in Q1 and obviously now the launch of Gamifant. We are really now resetting the base of the business on a completely new level. Please take note that obviously Synagis is a very seasonal product as we reported. Actually, the main sales are happening in Q1. Also for us this year, particularly will be Q4. Depending on the virology, there will be an onset already in September. Please also take note that we only closed the transaction on the 24th of January, so we are missing an important part of the January sales in our books. Notwithstanding this, what we can say is that the business is really taking off very nicely. We had nice sales of Synagis in Q2.
Really what is the shining star now emerging is Gamifant and the very positive trend now for Kineret in Q2, this is driven by our U.S. performance, but also by the rollout of the Still's disease indication in Europe. Next slide. Here, basically, you see the Kineret in more detail. You have the very strong growth in the quarter. I mentioned the U.S. now, which is pulling through. There was a leadership change in the U.S. and a refocusing of the team. Overall very gratifying results. What we basically can see is that we improved the fill rate, but also new patients now enrolled, and we have improved the stickiness of the product by basically working better with this new distributor, specialized distributor, and this is now paying dividends. Next slide. It's the largest with SEK 148 million, very strong sales for this off-season quarter.
Affected also by a one-off of SEK 81, which is related to a more informed understanding now on what basically is Medicaid and Medicare. Hence, we felt that it was an indication to have this one-off of SEK 81 million, this reversal. Still, the viral season lasted longer this year, and this helped us to achieve this result. I think for you, more importantly, I think you should understand that the product underlying demand is still increasing at 2.5%. Obviously, working very intensively to improve the product. That was our, let's say, main objective when we did the acquisition, that we wanted to show by focusing on this product, that we can do a better job and drive growth. Our main focus is obviously reducing the leakage and improve adherence to the protocol.
We think that we are by far not yet we have reached the end of this objective. We hope that we can do better. Proof is in the pudding in particular than in Q4. With Gamifant, let's say very strong Q2, but it's early days, so we want also to have here more of a measured approach. Let's say we can see that there is a very significant uplift. Physicians see that a lot of utility for this product. Basically, it's too early for us now to revise our guidance, but obviously, as you can see, we are very positive, and it looks to the future of the product, and we are on the right track. In Europe, we had a dialogue with CHMP, and we think, based on the normalized approval timeline, that we should have an approval more like mid-2020.
This is not obviously in our hands. We will do everything we can to make sure that CHMP can make an informed decision. This gives you a little bit of a flavor on the product, and now I refer back to Milan, who will show you the clinical trial program, which is very important to us.
Thanks, Guido.
Over to you, Milan.
Thanks, Guido. This slide gives an overview of the completed, ongoing, and planned clinical activities with emapalumab. We have the original pivotal trial in primary HLH, including the extension study, the 04 and 05, as well as the 09 study in primary HLH to accrue more information also on long-term outcomes and quality of life. The study in malignancy and non-malignancy associated HLH in adults is about to be initiated. Finally, we have the secondary HLH study that I'll share more details with you on the next slide. This slide shows the design and outcomes from the ongoing study in patients with systemic juvenile idiopathic arthritis developing secondary HLH or macrophage activation syndrome. sJIA is part of the juvenile idiopathic arthritis diseases and also has systemic features beyond arthritis, such as fever and rash.
Around 10% of patients with sJIA, a secondary HLH or MAS, may develop, and this is associated with significant morbidity and mortality. There is today no treatment available for this secondary HLH, MAS, and patients are typically initially treated with high-dose steroids. As we have presented previously, patients with this form of secondary HLH, they have an elevated interferon gamma levels, and this was the rationale for initiating this study. As shown here, we enrolled patients with MAS secondary to sJIA, having failed high dose of steroids. They were treated with an initial dose of emapalumab of 6 mg/kg for two weeks, followed by a dose of 3 mg/kg for the subsequent two weeks. The dose of steroid could be changed during the course of the study.
What we observed in this difficult-to-treat population with high morbidity and mortality was quite remarkable in our view. We saw a complete response to emapalumab in six out of six patients, all of whom had failed conventional steroid therapy. We saw a rapid decrease in CXCL9, demonstrating complete neutralization of interferon gamma. We saw the treatment response occurring early and also with a clinically meaningful tapering of the steroid dose already from week one. Finally, emapalumab was well-tolerated. There were a few infections. There was one case of CMV reactivation that was considered related and serious, but this was resolved with conventional antiviral therapy with no sequelae. In summary, we are very encouraged by these interim clinical data, and we plan to share these with the FDA to discuss a potential way forward for this indication.
I hand it over to Henrik, I believe, for the presentation of the financial results.
Thank you, Milan. Let's start with a financial summary of the quarter. Revenues for Q2, as we saw, amounted to SEK 3.163 billion, corresponding to an increase of 38% and 32% at constant currencies. The year-on-year growth was driven in almost equal parts by hemophilia and immunology. In terms of organic growth, that is adjusting for Synagis, it was 25% for the quarter. Gross margin jumped to 76%, positively impacted by the addition of the high-margin products Gamifant and Synagis, the continued positive product mix effect driven by the hemophilia franchise. At the same time, a lower revenue sale from some of the specialty care products. EBITDA adjusted for the restructuring charge in Q2 of SEK 157 million, reached SEK 1.193 billion for the quarter, corresponding to a margin of 38% versus 42% in Q2 2018. The finality of Synagis here has an impact.
The revenue will negatively impact the margin in Q2 and Q3, whereas we will see the positive impact on the product in Q1 and Q4. Finally, the Adjusted EPS number was SEK 2.12, - 17% for the quarter, and we're growing 16% in H1 compared to last year. Furthermore, the operating cash flow was very strong during the quarter of SEK 1.275 billion, catching up from the weaker cash flow that we had in Q1. As a result, net debt amounted to SEK 4.4 billion at the end of the quarter, which is a decrease of about SEK 1.1 billion compared to Q1. We go to next slide. On this slide, we have a crosswalk illustrating how we are building our business. We're comparing Adjusted EBITDA for Q2 2019 with the same period 2018. Again, Adjusted EBITDA, meaning excluding restructuring costs.
Overall, the Adjusted EBITDA of SEK 1.193 billion corresponds to an increase of SEK 242 million year-on-year. First of all, the increase in revenues coming from highly profitable products in hemophilia, as well as Gamifant and Synagis, has contributed an increase in gross profit of SEK 736 million. However, as we are building the business, that means also increasing efforts in SG&A. We've taken over the Synagis business and established a commercial infrastructure in the U.S., and we have launched Gamifant in the same U.S. market. At the same time, we've increased our investment into hemophilia as we continue to drive that growth. As a consequence, SG&A increased by SEK 377 million. We are obviously dealing with a much larger and a growing business.
The R&D line increased by SEK 115 million, including the restructuring costs, and this relates to the increased activities in our R&D programs with emapalumab obviously being the major driver. We expect to continue to see some increase in spend in both cell and marketing and R&D as we move into H2. Finally, I want to bring up the financial impacts of two important events this quarter. On next slide. First, we have the intention to discontinue early research and R&D programs outside of core areas. Restructuring costs for the quarter amounted to SEK 175 million, whereof SEK 157 million impacted EBITDA, and SEK 18 million related to the impairment of intangible assets.
We expect that this restructuring will release SEK 200 million-SEK 300 million in 2020, giving us the possibility to reinvest in our core areas. Secondly, there is the impact of the agreement to acquire emapalumab and the related assets.
The consideration for the acquisition is CHF 515 million, of which CHF 400 million was previously committed in the emapalumab license agreement. Through the acquisition, we gain access to three main items, all assets relating to emapalumab, including the in-house expertise, options for the shared financial rights of two immuno-oncology products, and a priority review voucher with the FDA. This acquisition was debt-financed and will increase our net debt position to SEK 9.3 billion on a pro forma basis as of Q2. Leverage, however, will remain below two, as we can comfortably lever up to three to 4x the EBITDA, and we continue to see very strong cash flow from operations, there is significant additional net capacity for further M&A. With that, I hand over to Guido again.
Thank you so much, Henrik. Let's go straight to the key messages. Basically, we are committed to the strategic direction.
As we actually laid out as early as September 2017, obviously, with the refinement now that immunology is our second leg. Clearly, we are committed to further drive penetration in hemophilia. We are excited about the opportunities related to BIVV001, and we see a lot of excitement still around our existing franchise, and recent data demonstrate that we have fantastic products. When you look at the opportunities in the U.S., we obviously have a very different setup in the U.S. This you have seen also in the financials. We strengthened this organization, but now we have a significant platform in the United States, and we are very well positioned, obviously, in EMENA, and we have strengthened this position, particularly, by the investment into our hemophilia organization.
We are also working on our late-stage pipeline, we see a significant opportunity related to emapalumab beyond also HLH, but even within. We're committed to M&A because we want to make sure that we remain also forward-looking, a strong, growing company in this rare disease space, we can assume now in this pathway to assume a leadership position in a rare disease context. With regard now to our financials, we come, obviously, with very strong financials into this first half. As a consequence, we felt that it was appropriate to uplift guidance from SEK 13 billion-SEK 13.5 billion. Basically, here, the current trend makes us more confident that this is appropriate. Also on the EBITDA, we think that we can uplift the range, excluding, obviously, the restructuring cost, as explained by Henrik.
This updated outlook really reflects the feedback we get on the product sales in hemophilia, but also from the strong uptake of Gamifant in the U.S. I think now it's time to open the floor for questions as they may arise. Thank you.
Thank you. Ladies and gentlemen, if you do have a question for the speakers, press zero one on your telephone keypad now. That's zero one on your telephone keypad. We now have our first question from Eun Yang of Jefferies.
Hello.
Good morning, Eun.
Good morning. Thank you. I have two questions. One is on hemophilia and second one is in Gamifant. On hemophilia, you mentioned that most growth in the quarter came from major EU markets, but also it was positively impacted by the ordering patterns in the Middle East. Can you quantify the impact from the Middle East and comment on whether you expect that ordering pattern to continue in the second half of this year?
Yeah. The Middle East, this is more driven by the way these tenders go, and we have, obviously, a very strong position in the Middle East, particularly, in markets like Saudi Arabia and the UAE. When you look at the overall performance in case of Elocta now, basically, we have shown now, if I just look at the first half, we have, give and take, SEK 670 million gross in absolute terms. Basically, the effect from the Middle East overall on the half year is a 5% effect. It's not the main activity. Really what drives the growth are the primary markets, obviously, in Europe, where we still see a strong patient uptake. Then we have some growth now that we see in Central Eastern Europe, and granted, this is early days.
Also, obviously, there, the legacy is these are more traditional plasma markets, and there we basically see a gradual shift now towards more modern therapy. Yeah.
Okay. Do you think that the Middle East ordering pattern that you saw in the second quarter to continue in the second half of this year?
Basically, there is nothing unusual, let's say, to this because it is just the way these legal setups are in the Middle East. Yes, you will not see it now every month, but on a half-a-year basis, yes, you should see the business repeating. Absolutely.
Okay. Thank you. Gamifant. The pretty strong growth since the launch in the U.S. Do you think that the growth is largely driven by off-label use in primary HLH, or do you think that it is also coming from off-label use in secondary form?
What we see is that there is a strong uplift, obviously, in primary HLH. You can also see that there is utility of the product in very severe cases in the overall HLH indication, and there physicians obviously make decisions, let's say, to basically rescue patients and with due respect to this.
Okay. The last question on Gamifant. You mentioned that you met with the EMA, now approval is expected in mid next year. That is about six months push from year-end of this year. Is that because approval process is more standardized than accelerated as you expected?
Milan, you want to comment. Because you have been in close contact with the authorities.
Yeah. I think this is just based on the way the clock stop works and our ability to provide questions and answers to these. That's why we have postponed, you can say, when we expect the approvals from mid-2020.
Thank you.
Our next question comes from the line of Richard Parkes from Deutsche Bank. Please go ahead. Your line is now open.
Hi. Thanks very much for taking my questions, and congratulations on a great quarter. Firstly, I'll take them in turn. Got a few questions. Firstly, on hemophilia, can you talk about any geographies in your hemophilia territories where you're seeing the access to reimbursement of Hemlibra in the non-inhibitor setting as being approved, or you're expecting it to be approved imminently and can start to impact your close prospects? That's just the first question.
Yeah. Richard, I think you may want to understand that, yes, we have obviously some visibility on this, but I think this will be a very good question for the earning call of Roche, which is happening one of those days. I think then you get a much more profound answer to this.
Okay. No problem. Then second question on the Gamifant EMA process. I just wanted to push you a little bit more. In a clock stop, I assume there's either sort of questions or data requests from the EMA as part of that. I'm just wondering if you could give us some kind of clarity on what issues the EMA has and how confident you are that that can be addressed based on the current data set.
I think, before Milan answers, if we wouldn't be confident that we can resolve it, we would not give you a timeline, obviously, as the way we have done. Maybe, Milan, you can provide some more color.
Yeah, no, I agree, Guido. Based on the visibility we have, we expect an approval by around mid-2020, and this is as far as we can discuss today, I think.
Okay, no problem. Finally, I just wondered if you could talk around scenarios for the secondary HLH setting and potential for filings. I know you plan to discuss that data with the FDA later this year. What's your kind of thoughts around best case, worst case filing timelines? Is it possible that you could be able to file based on this clinical study, or do you think further clinical trials will be required? Thanks very much.
Thanks for your question. I would prefer to answer that question once we have discussed with the FDA. I think we will be able to provide a bit more specificity around what it would really take. Needless to say, we are encouraged by these emerging six patients. I prefer to get back with more specificity once we have discussed with the FDA.
Okay, great. Thanks very much.
Thank you, Richard. Yeah. Appreciate it. You can see that for Gamifant, obviously, in particular, there will be some broader horizons that will open up the new indications. Also, over time, we would like to update you on our plans for new geographies because we think that there's a broader utility of the product.
Perfect.
Our next question comes from the line of Chris Riuti from SEB. Please go ahead. Your line is now open.
Chris? Can you hear me?
Yes, we can hear you now.
Okay.
Yeah, Chris.
Yeah. Great. Regarding Elocta, to start with that, and ITI, do you plan to apply for approval for ITI? I guess we can just take them one by one.
Yeah. Obviously, these are interim results of verITI-8 , and we have another study ongoing for reiterative. It may be a little bit premature to talk about before the final readout of the study in what way this way may suffice for publication. The way the studies were set up was primarily to elucidate the overall knowledge in ITI and the benefit of treatment. Obviously, very gratified to see the relatively fast response to tolerize patients. Milan, maybe you can talk more about that.
No, I agree. I think once we have completed the studies, we will evaluate the outcomes. Then based on that, we will take a decision as to whether these data merits approaching the regulatory agencies. As we said, we are quite encouraged by the early interim data, in particular on time to tolerization.
Okay, great. I guess, just wondering in terms of, obviously very strong results, so there's no signal in the numbers. Have you had any pricing pressure in Sobi territory for hemophilia? Particularly, I guess, with respect to how much they're preparing to come on the market or something like that.
I think any data point that we have learned so far indicates to us that the launch may not affect negatively the price level. Basically is also a question you need to refer to Roche, honestly, on their pricing strategy. Anyway, the data point that we have collected don't suggest this. Let's say the other thing is that, yes, there has been, obviously, in the normal course of business, there have been renegotiations. The overall demand growth has been strong so that the mix effect, it basically shows still a very positive variance. We have not seen now a dramatic shift on the price level when you look at it on the business in its entirety, yeah.
Okay, great. Just with Synagis sort of details, we have in the past seen negative sales at AstraZeneca. Is this something that we could see in future off-season quarters, do you think? Is there a specific reason that sort of thing happened?
Yeah. No, basically, this is it. You know that basically the accrual mechanisms, when you sell, you don't know sometimes how much goes into Medicaid and how much goes into the private channel, and then you have to make a certain peg in the ground. We don't profess that we can predict these things though with 100% accuracy. This is not a science. This is to a certain degree, is a judgment and an art. We think that we are very much on the ball because obviously, for us, obviously, the relative impact of Synagis is much larger than it was with AstraZeneca. We want to get it right.
What you see now in the Q2 results is really emphasizing that we want to do it right and get it right, and we basically use all the data points that we were able to get our hand on and basically do this. That's the reason we have not seen the negative result, yet we got an advantage of the virology. There's always this, you will never have a 100% prediction on the result. They could continue, and you know the way this works with Medicaid, they can come back to you even up to two years later. There's always an opportunity for, let's say, for a surprise. From our perspective, we just looked at the way we think the product is going. We studied it very carefully, let's say, at a detailed level.
The data points suggest right now a demand increase of 2.5% of the product. And if we can increase demand over a period of time, then obviously the actual sales will follow. And for us, to be honest, Synagis is the product in the United States, and it is the number one product at this point of time for immunology. Maybe at one stage, Gamifant will surpass it. But, for now, it is clearly the priority, and we think that we should do a good job, let's say, when you look at the later part of the year. Obviously, to be proven. And let's say nothing beats than the proof, but you have to be patient a little bit with us to see the Q4 results. And let's say we are doing now in the off-season, obviously, everything we can to build up the right patient flow.
Okay. Great. The last thing is sort of related to sort of strategy on R&D. So notwithstanding the sort of refocusing on Hematology and Immunology, you've stated very clearly you want to expand the late-stage pipeline, okay, fine. But I guess the downside of focusing on the late stages that there tends to be lower return on investment, assuming in-house origination, business development for early-stage candidates. So I mean unless you're just trying to sell Sobi off, why sell off SOBI003 and the rest of of the early-stage assets assuming you believe in them?
Yeah. When you think about our pathway, I think strategy is as much about what you do as what you don't do. Here, basically, we said, when you read it carefully, let's say, or we try to say anyway, is we stopped research in our non-core areas, but we didn't say that we stopped research in our core areas. Yeah. Let's say, basically, what we now, obviously, the emphasis is clearly on late stage. When you look at, you do a risk adjustment, with the probabilities on an early stage versus a late stage. I'm not sure that your ratios or your return ratios, when you risk adjust them, will be really much better, provided you make smart buys of late-stage assets.
So far, we feel that we have been actually reconfirmed by what we are doing. We see a much bigger opportunity in the now development of emapalumab indications than we saw, to be honest, in the case of the assets that we are now going to divest. What you will see is hopefully that over time, we can articulate clearer that more projects will come our way. We think that for the company size we are, you need to basically balance it off, and clearly, there is no mandate now to sell the company or to do the short term. When you look at our financials, how we have investing in the business, then actually, no matter what the gospel is you think we are selling here, just look what we are doing, then you understand what our real strategy is.
Our real strategy is that we are investing into the business, and we don't deleverage. Because if you want to get a leveraged P&L, obviously, we would have a short-term ambition. You could arrange this, yeah. We believe in the long-term or longitudinal nature of this business. Therefore, we're doing investing into good projects, we think. We think that SOBI003 could be a great project in somebody else's system. It leads us into an area that we think, because then you need to build up an entire value chain, and we think that there's more to gain for us in the value chains in our core areas. Yeah. I hope I didn't avoid the question. We think this is a pretty sound strategy.
When you look at some of the most prominent biotech companies in the world, one of them owned by a large, big pharma company, you ask yourself, how many projects did they bring from the bench to commercialization? Maybe not so many, yeah. Let's say, there are a lot of projects coming because they were interfacing and connecting competently with certain areas, and that's basically we want to get entrenched in our core areas so that we become the partner of choice and then can bring the scale, let's say, to those projects, and then bring them to the market. Yeah. That's really what is the reasoning behind.
Okay, thanks very much.
You're welcome.
Our next question comes from the line of Johan Unnérus from Pareto Securities. Please go ahead. Your line is now open.
Hello? Excuse me, we cannot hear you.
Please go ahead. Your line is now open.
Yes, I'm trying. Can you hear me?
Yes, we can hear you now.
Oh, brilliant. Thank you. Congratulations. Great quarter. Just a few questions on Gamifant. It seems to be an extraordinarily good launch. Q1 was strong. You were alluding to some inventory effect, as often is the case in the initial launch. Q2 is clearly very solid again. Can you provide us with some details what to expect? You're not guiding on particular products, of course, but should we expect very rapid uptake in the initial label, or is this just a very good start? How should we look at it?
I think it's early days for the project, but obviously, the Q2 data are very encouraging. For me, what is more important is that we got very strong data points from the physicians who treat patients. Now, the reason why we are refraining right now from providing more detailed guidance, obviously, we normally don't provide product guidance anyway. You've seen that we are more bullish, obviously, for the second half, and clearly, Gamifant plays a role in this context. It's also that you want to have a couple of more data points on the percentages, on the, so to say, repeat prescriptions. You have, obviously, now the product is used in numerous centers. You have also an uptake across centers. Where you see repeat, you see also obviously satisfaction with outcome. That's the reason why we are at this stage.
We want to make sure that we get it right. We think, though, that it's a fantastic product in making a significant difference to patients' lives in the broader HLH indication, and that's the reason why we're actually quite confident. Yeah.
Thank you. Synagis, now, when you have more experience from the U.S. market, even though, of course, Q2 is not in season. In retrospect, Q1, when we're thinking about what's a reasonable baseline for a more typical Q1, if you would have had the product for the full quarter, can you give us some more details? It was obvious that you didn't have the support from the full Q1, what's a reasonable baseline? How much more should we base it on for Q1 going forward?
You see, there were two effects that we tried to provide quite a bit of data points at the Capital Market Day, on how to read the performance. Because there was an inventory effect and there was an effect that basically, let's say, was driven by the later close on the 24th. Obviously, as we also explained, we got a compensation of a lower purchase price that unfortunately didn't find its way into our P&L, but basically meant less cash out for the transaction. We got a compensatory effect of over $30 million. Let's say, that basically I think you have to add back. I think for you as a data point, I think, let's say, and maybe what we could do is trying to provide you with the presentation from the Capital Market Day, which is public knowledge.
For you then maybe to do your own adjustment, because when you then think this is one-offs through and we give you the data point of 2.5% ongoing demand, and I give you another data point that obviously we think, with what we are doing, we can hopefully do better. Yeah. You might be able to compute this. Also here, in the case of Synagis, we don't give guidance on an individual product. We think that if you take away these one-offs, we will be able to grow the product and basically create a solid foundation for the product and make sure that within the guidelines that have been established three years ago, we can basically grow the product by improving adherence and reducing leakage.
No changes there from the capital market then. Finally, you alluded to that we should expect some growth then from R&D and SG&A in the second half of the year. That could be a broad indication. What is some growth? Is it 10% more, 5%, or 15% more?
Henrik, you want to answer this?
Yeah. We increased our guidance on revenue. We think it's only natural that also the OpEx will increase. This is no major increase. It is slightly higher number for H2 than we expect for H1.
Great. Thank you.
As a reminder, if you do wish to ask a question, please press zero one on your telephone keypad now. If you find your question has already been answered, please press zero two to cancel. We now have our next question from Jon Berggren from DNB. Please go ahead. Your line is now open.
Yes. Hi. Thank you for taking my questions. I have a quick one for Milan. If I understood your comment on BIVV001 correctly, I think you said that it has the potential to offer not only longer half-life but also greater exposure. Please just elaborate a little bit on what you mean by greater exposure. Thank you.
Yes. Thanks for the question. I think if you look at the curve, I think historically there's been a lot of discussions about trough levels in the hemophilia space. What we want to do is we want to move the conversation to talk about the total, you could say, area under the curve that we are providing of hemophilia protection. That's why when you look at the 65 units per kilogram dose, you can see not only a very good trough level, assuming a once-weekly dosing algorithm, which is a speculation for now, but what you can also see is you see very high exposures in the beginning of the week supporting more protection, a better ability for patients to normalize their lives. This is the conversation that we want to move or the direction of the conversation that we want to take.
Okay, good. Thank you.
It is the area under the curve that you can say provides a better measure of what level of protection you can get. On top of the fact that you also have very good peaks that normalizes, at least in the beginning of the week, you can say the factor VIII exposure. That essentially means that in that period of the week, these patients would be normalized essentially. We want to move away from the trough discussion, and we want to move towards the full exposure and describing that, because we think that's more meaningful clinically. We also think that that is connected to our fundamental vision of being able to liberate the lives of people with hemophilia A and B. Thank you for your question.
Thank you.
Thank you, Jon.
We have no further questions. At this time, I'd like to hand back to our speakers.
Thank you so much for your interest, I know that this was probably an inconvenient hour for those dialed in from the U.S. We try to do this better next time. We respect your interest, and we very much appreciate it. Look forward to staying in contact with you and keep you tuned. Thank you so much. Appreciate it.
Thanks.
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