Thank you very much. Good morning, good afternoon. Welcome to our nine months 2021 results call. I will be happy taking you through the call with a couple of my colleagues, who I’ll introduce later. But before I do that, I would like to point out to the forward-looking statement slide that you see here because we will be making some forward-looking statements that are based upon our current beliefs, expectations and assumptions regarding the future of our business and things can always change, as you know. So, let me go to the next slide, please. And my colleagues who would -- who will be speaking to you as well will be our Chief Medical Officer, Dr. Anurag Relan; and our Chief Financial Officer, Mr. Jeroen Wakkerman, who will speak to you as well. So -- but I will be kicking it off and give you an introduction and talk about the operational growth. Next slide, please. Yes. Thank you. So if we’re looking at our business today, we see a well-funded business supported by commercial sales and a growing pipeline for the treatment of rare diseases and unmet medical needs. And our lead product, RUCONEST, or recombinant human C1 esterase, inhibitor is launched in over more than 40 countries with a sales of more than $146 million in the first 9 months of 2021. And very important, we have a potential near inflection point, a significant inflection point with the anticipated end of 2022 launch of leniolisib, in-licensed from Novartis, for the treatment of orphan disease APDS, activated phosphoinositide 3-kinase delta syndrome, we will now call it APDS going forward. We’re also targeting new large indications to C1 inhibitor within Phase II studies, and we have an early stage pipeline assets, including recently in-licensed potentially curative gene therapy treatment…

Thank you, Sijmen. I’d like to begin by talking about hereditary angioedema and our new collaboration with Orchard Therapeutics with our product, OTL-105. And with this collaboration, the goal is to develop and commercialize an ex vivo autologous stem cell therapy product, gene therapy product for hereditary angioedema. The product will insert one or more functional copies of the SERPING1 gene into patients, and this will use their own hematopoietic stem cells. And this is done ex vivo, which are then transplanted back into the patient. And the goal is to be able to provide a potential durable C1 expression. In preclinical studies to date, we have seen that OTL-105 demonstrates high expression levels of the C1 inhibitor protein using lentiviral-mediated transduction in multiple cell lines, including stem cells. And we’ve also been able to see that the C1 inhibitor that’s produced is functional in a clinically validated assay. Together with Orchard Therapeutics, we’re able to leverage each of our expertises. And with Orchard, we have a partner that has expertise in gene therapy, in developing these vectors. They have an established network to manufacture the product. They’ve done many animal studies, and they have discovery capabilities. And on our side, we have significant clinical and commercial expertise in HAE, of course. We have an ability to assist with the preclinical disease models for HAE. And we have, as you’ve heard from Sijmen, capital to fund ongoing development and future commercialization. Together, this combined expertise goal is to bring a best-in-class HAE gene therapy to provide a potential cure for these patients with a single administration of OTL-105. The way this works is that it begins with harvesting cells from the patient. These stem cells are then purified. And then outside the body, again, ex vivo, a working copy of…

Yes. Thank you very much, Anurag. The financial highlights for the first 9 months of 2021, and there’s a subtitle called building a sustainable business, and that’s obviously reflecting the efforts we’re taking on having RUCONEST as the cash generator at the moment, but also building more and more for the future. So that is leniolisib for the, let’s say, medium term and OTL-105 for the longer term, next to our other in-house product development efforts. So we are creating a more balanced portfolio for the future. And that’s also what you will see when I go through the numbers, amongst others in the operational cost. Q3 showed a 6% increase in sales from Q2 this year. And looking for the year-to-date numbers, we have a 4% decrease. So what we basically see in the sales is an ongoing recovery quarter-on-quarter in sales following the impact from COVID-19, especially in Q1, on the U.S. health care economy. And that was previously noted in our earlier financial reports as well. Then if I look at the sales and especially the regional split. The recovery in the U.S. was sharp with an increase of 6%, and the drivers being basically new patient enrollment. Every quarter, we increased the number of new patients being enrolled. But also ongoing product demand despite the prophylactic products that Sijmen also talked about, which seems that the growth seems to be stabilized against acute products. For the first 9 months in the U.S., we had a decrease of 3%. And in Q3, in the rest of the world and Europe, sales were $1.9 million, which is a big increase compared to Q2. But that is mainly because of phasing and which we have seen quarter-on-quarter in Europe and the rest of the world. But also, we entered…

Thanks, and before I do that -- thanks, Jeroen. Before I do that, I would like to summarize that you’ve seen our well-funded business, supported by commercial sales and a growing pipeline for the treatment of these rare and ultra-rare diseases and unmet medical needs. The lead product from our platform, RUCONEST, as you’ve seen, stable, growing, picking up growth again, and we are optimistic towards the future that growth continues. And we realized $146 million in the first 9 months. I’d point out again that we have a significant potential near inflection point with the anticipated launch of leniolisib towards the end of next year that we in-licensed from Novartis and you heard Anurag talk about it and about our patient finding efforts that have just started and already have yielded more than 350 APDS patients that were identified, and we continue -- in fact, we will increase the activities of this next year for this, of course. We’re targeting the new launch indications for C1 inhibitor. We have early-stage pipelines. Again, you heard Anurag explain our in-licensing of OTL-105. And of course, we are able to leverage further our commercialization infrastructure in the U.S. and Europe for in-licensed products and expanding manufacturing capacity. And we’re on the hunt for additional late-stage assets to add to our portfolio and further leverage the commercialization infrastructure of the company with products that can be launched between now and 3 years’ time. And last but not least, the experienced leadership team and strong balance sheet that continues and can support our ambitious growth strategy, including those potential M&A transactions. With that, I would like to hand over back to the operator now and open the floor for any questions that you may have. And we also have here present our Chief Commercial Officer, Stephen Toor, to answer any questions that you may have on commercialization. So operator, please open the floor for questions. Thank you.

[Operator Instructions] We have one question from Hartaj Singh from Oppenheimer & Co.

Great. I just got a couple of questions and then 1 housekeeping question after that. So, on the OTL-105, can you just kind of walk us through, Anurag, where you are or where Orchard is in terms of just the manufacturing of that product? Are you in that sort of clinical stage? When will we get to commercial state sort of manufacturing? And then, what are some of the investments that will be sort of needed around that? For leniolisib, I just have a question in terms of -- if you recruit that close to 40 patients that it seems on ClinicalTrials.gov that you’re going to recruit, you’re going to have more than 10% of the patient population you identified in the United States. But how certain are you that, that 1 trial is going to be enough, Anurag? That the -- what is your level of conviction and certainty that the regulators are going to be comfortable with 1 trial in this indication? Again, like I said, you’ve got a big patient population there as a percentage of the total in terms of approval next year, hopefully, assuming the trial is positive. And then I’ll just follow up with a quick housekeeping matter question on manufacturing.

Anurag, can you -- want to take these, please?

Sure, thanks for the questions. On OTL-105 in the collaboration with Orchard, this is still -- the work that’s going on right now is still in the preclinical stage. So the manufacturing is really centered around that. I think over the course of the coming quarters, we’ll be able to provide you a little more information on how that’s progressing and the investments that we’ll be making there. Now to take your question on leniolisib, the pivotal study is 30 patients, as I mentioned, and this is a randomized double blind placebo-controlled study. This was designed really with feedback from the regulators. And as you’re probably aware, this is a typical design that’s required -- in a single study, that’s required in this type of rare and ultrarare diseases. So we’re fairly confident that -- and I think not only is the study hitting the endpoints, but really looking at the totality of the data so that we see the endpoints that I’ve mentioned on the immunophenotype, but also on the lymphadenopathy as well as other measures that are likely to be observed, secondary endpoints, and really the overall picture that we observed from the study will be supportive and potential for regulatory approval, both here as well as in Europe. And you said you had a follow-up question, Hartaj.

Yes, Anurag. And just the follow-up question was that as you build up the manufacturing for leniolisib, I assume you’re going to sort of expense that through the R&D line, but then it becomes inventory assuming approval next year, which has certain implications on your cost of goods sold in your gross margin, assuming leniolisib is going to get approved next year.

Jeroen, you want to answer that?

Yes. So the products that will be commercially used will indeed just go to inventory next year and the rest will go -- some for development purposes, will go through the P&L. That’s the way we will treat it going forward.

We have another question from Joe Pantginis from H.C. Wainright.

Just a couple of logistical questions, I guess. First, Sijmen, do you think you can give us any more color on the additional indications you might be looking at? Obviously, we’ve talked about things like pre-eclampsia in the past. With regard to the AKI study as well as combining with the other studies, are you seeing any impact yet with regard to opening up sites or current sites about how it might be loosening up due to -- from COVID restrictions? And then, lastly, on your regulatory efforts for RUCONEST, what -- how should we sort of define your efforts to get it approved in additional countries?

Yes. Okay. First, with regards to clinical trial progress. In general, we see still, of course, that clinical trials are not on top of the priority list of many centers. That means that we are working on expanding the number of sites that are participating, for instance, the AKI study, to expedite the recruitment of that study. You’ve seen the sort of forward-looking statement that we were making on when we expect that study to be fully enrolled. But again, as you rightfully point out, COVID is not over yet. In fact, it’s coming back in a lot of areas in hospitals. And as many of our other colleagues in the industry, we’re not yet out of the woodworks at all with regards to the normal speed of clinical development. That’s one thing. Would you like to add something to that, Anurag? Or is that sort of reasonably summarized?

Yes, that’s a reasonable summary, I think. Joe, there’s still a lot of COVID-related fatigue also out there. A lot of these centers were involved in COVID studies, and it’s just -- they’re still trying to climb out of all of that mess. So I think things are improving, and we’re going in the right direction. But it’s still -- it’s been a slow, sputtering start coming out of COVID.

And with regards to pre-eclampsia, we haven’t started at all coming out of COVID at all. So I think that was your question, right, Joe?

Correct.

Yes. Then with regards to getting RUCONEST approved in more territories. Yes, we’re taking a selective look at this, obviously. But you’ve seen that we recently got the reimbursement sorted out in Spain. We’re also obviously looking for another country that is typical -- that’s one of the big 5 Europeans, that’s Italy, and we’re working towards getting reimbursement there as well. Obviously, the product was approved a long time ago, but reimbursement is a different game in these kind of territories. And you saw, of course, the collaboration with NewBridge where we expand as well into the North African and Middle Eastern territories. So, step by step, we’re taking it further forward. As you know, RUCONEST is hampered by the fact that in the rest of the world outside of the U.S. or everything is referenced to European prices, which are coupled to 1980s [blocked] product prices. And therefore, hereditary angioedema, for none of the companies involved, is commercially very interesting indication in this respect. So therefore, it’s difficult. But on the other hand, our strategy is to get a bigger geographical footprint, obviously, because rolling out leniolisib will be a very different story in this respect. And therefore, we will continue to add additional territories for RUCONEST. And of course, when leniolisib comes on, it may actually drag RUCONEST with it into new markets where we might enter. Does that answer your question, Joe?

It certainly does.

Any more questions, Joe? Thanks.

We have another question from Simon Scholes from First Berlin.

I’ve got 2 or 3. I mean, first of all, I was wondering if you could give us a timing on submission of the IND application in Pompe? Secondly, I was wondering -- I mean, I’ve noticed over that a number of gene therapy-based approaches are now in trials on Pompe. And I was just wondering if you could comment on how your own approach stacks up against those? And thirdly, just on the marketing costs. I think year-on-year, you’ve had a $7.7 million increase. I was just wondering if you could split out how much of that increase relates to leniolisib and other items and how much relates to RUCONEST?

Yes. Shall I answer -- the first one first then, Simon, about Pompe. Pompe’s disease, we’ve taken -- of course, our product -- our development is hampered significantly at this point in time by unavailability of materials necessary for manufacturing. That is a problem that we have in the pharmaceutical supply chains widely, and we are no exception for that, unfortunately. Secondly, so I can’t give you a proper date for the IND. With regards to the uncontinued medical -- unmet medical need. We’ve just done a deep dive into this indication. And we concluded that the unmet medical need is there -- is still there, and we expect it also to continue to be there. Also, because gene therapy might have some additional hurdles in such a lysosomal storage disease as Pompe compared to many of the other diseases. So the answer is we continue to be interested in Pompe. We’re significantly delayed because of the COVID issues with manufacturing, and we have no data at the moment for an IND, therefore, as these supply chain disruptions are widely spread and COVID is not going back and not retreating, in fact. So it’s difficult to say at the moment. That’s my first question. Second one -- the second one, Jeroen, could you answer that?

Yes, that was on the marketing cost. So the increase of $7.7 million, how much of that is leniolisib. Out-of-pocket expenses for leniolisib was $2 million out of the increase of $7.7 million. And the rest is, I would call it, kind of infrastructure cost. So higher spend in general in Europe and the rest of the world. Some of that is for RUCONEST, but we are building our commercial infrastructure in Europe and the rest of the world. And that is not only for RUCONEST. That’s also looking forward to leniolisib. So part of that will -- is RUCONEST, part of it is leniolisib. Difficult to say now what exactly the split is, but the out-of-pocket expenses increase for leniolisib was $2 million.

This is clearly a strategic investment, right? So we want to launch leniolisib far more -- far faster than we did RUCONEST. And of course, the opportunity for leniolisib is significantly bigger -- very significantly bigger in Europe than, of course, this for RUCONEST.

Yes.

Okay. And is the $2.2 million, when you’re saying -- when you’re talking about the $2.2 million, are you talking there about the patient finding costs mainly?

Yes. Yes, that’s a big part of it. Yes, exactly.

And you had more questions, Simon, you said?

No, that’s it.

[Operator Instructions] It appears we have no further questions at this time.

Okay. Thank you. Maybe some closing remarks then. Thank you very much for attending our conference. And we clearly look forward to, as I said in my quote, to the next milestones. We clearly look forward to seeing the results of the leniolisib trial results in the beginning of next year because we believe that this product especially is important for the execution of our strategy because we think it’s a transformational -- not only transformational potential product for APDS patients’ lives, but it’s also a transformational commercial potential for our company. And that’s why we’re looking very much forward to that. So, thank you for attending here, and we look forward to seeing you again at our next conference with our next results sometime in March. Thank you. Goodbye.