Pharming Group N.V. (PHARM) Earnings Call Transcript & Summary

Good afternoon, ladies and gentlemen. I'm Paul Sekhri, Chairman of the Board of Directors. And as such, I would like to welcome you all to this Annual General Meeting of Shareholders of Pharming Group N.V. I would also like to welcome our shareholders who are following this meeting through the live webcast. This year marks the 35th year anniversary in which Pharming has been on the market. And while this is surely something to be celebrated, I'd also like to say that this is a very important year in our company's history for many other reasons as well. On March 24, we proudly announced that the U.S. Food and Drug Administration has granted approval of leniolisib for APDS. For those of you who don't know what that is, it's activated PI3 kinase delta syndrome. I'll just refer to it as APDS. Approximately 2 weeks after approval, the first shipments of Joenja, the brand name used for leniolisib, for APDS, were delivered to patients in the U.S. The U.S. launch of Joenja is an important milestone for people in the U.S. living with APDS as they now have access to the first and only approved treatment option for this debilitating disease. The approval will also support our company in delivering on our commitment to serve patients who suffer from rare diseases. Sijmen will share more details during his presentation. To let you know, I'm sitting behind this desk here with the following nonexecutive directors, Deb Jorn, our Vice Chair; Barbara Yanni, Mark Pykett, Jabine van der Meijs, Leon Kruimer; and Steven Baert. Our CEO and Executive Director, Sijmen de Vries; to my left; and our CFO, Jeroen Wakkerman, to my right. The other members of our Executive Committee are also either present today or in this meeting room or online. I'm also pleased to welcome the Chair of our Dutch Works Council, Ms. [ Jan Lou. ] Last but not least, also with us today in the meeting room are Ms. Ingrid Buitendijk, partner at external auditor, Deloitte; and Mr. Paul van der Bijl, Civil Law notary and Partner at NautaDutilh. As a reminder, this meeting will be held in English. However, and for your convenience, please feel free to ask your questions during the Q&A sessions in Dutch, and we will translate this for you into English when necessary. Please note that the use of mobile phones and recording services is prohibited. So I would just kindly ask that you switch off your devices now in case you haven't done that already. This general meeting was convened in accordance with the applicable statutory requirements. The notice to convene was published on the 5th of April 2023 by way of an announcement in Pharming's website and a press release. The agenda and all the meeting documents were published at that same moment. As a result, valid and binding resolutions can be adopted today on all voting items on the agenda. All shareholders who are following the webcast have been invited to issue a proxy with voting instructions either online to our company or to the civil law notary, Mr. Paul van der Bijl of NautaDutilh. The shareholders who are present in this room and who have not issued a proxy earlier will have the possibility to cast their votes during this meeting. I will explain the voting procedure when we arrive at the first voting item on the agenda. And at that moment, I will also inform you about the number of shareholders and shares that are being represented during this meeting. These numbers are being verified at this moment. You're all invited in the notice to convene to send us your questions on the various agenda items by e-mail. None of our shareholders use that opportunity. In addition, the shareholders that are following this meeting online were invited to indicate also by e-mail, if they would like to ask their questions online. Unique log-in details have been submitted for that purpose. All shareholders who are attending this meeting in this room will, of course, be able to ask questions today on the respective items of the agenda. For an orderly conduct of the meeting, we will first answer each agenda item under the question -- we will first answer under each agenda item. The question is to be asked in the meeting room. Thereafter, we will answer the questions to be received online. I will invite the shareholders in this meeting room who would like to ask questions to go to one of the microphones in the room when we arrive at the questions-and-answers part for any agenda item. Also please raise your hand if you are not able to walk to these microphones, and we will then come to you with a handheld microphone. For the minutes, I kindly ask that you state your name and if applicable, the name of the shareholder that you represent before asking your first question. And finally, please limit the number of your questions to 3 to make sure that all shareholders will be able to ask their questions. You are, of course, welcome to wait in line again if you would like to ask additional questions. A full audio recording will be made of this meeting to facilitate the drafting of the minutes by our Company Secretary. Within 3 months from today, the draft will be published on our website for your review. And the final minutes will be adopted within 3 months thereafter, so by the 17th of November 2023 at the latest. Ladies and gentlemen, following these opening remarks, but before we go to agenda item 2, I would like to ask your attention for a statement on behalf of the Board regarding today's agenda. As mentioned earlier, we have received proxies and voting instructions from several shareholders. The Board is pleased that these instructions indicate that the majority of our shareholders voted in favor of all proposals on today's agenda. However, the Board took notice of the voting instructions of several foreign institutional investors, following the blanket policies of certain foreign proxy advisory firms, regarding the proposal to authorize the Board to issue shares or rights to acquire shares to finance mergers, acquisitions or strategic alliances. This mandate has been proposed under agenda Item 7, sub B, in addition to the mandate for the issuance of shares for generic financing purposes. The proposal includes the authorization to include the preemptive rights of existing shareholders. Under Dutch law, such authorization requires at least a 2/3 majority of the votes cast, if less than 50% of the issued capital is represented at the AGM. According to the voting instructions, more than 54% of the votes were cast in favor of the proposal. However, less than 50% of the issued capital is represented today. The Board of Directors wants to avoid any ambiguity regarding the outcome of today's voting and therefore, decided to not put the proposal under agenda Item 7, sub B up for a vote at today's AGM. Only of the proposal under agenda Item 7, sub A, will be up for a vote today. Ladies and gentlemen, I would now like to move on to the second agenda item, the annual report for the financial year 2022. This agenda item includes several subitems. I invite our CEO, Sijmen de Vries, together with our CFO, Jeroen Wakkerman to elaborate, first of all, on the business, the operations and results for the year ending on 31 December 2022. Our Chief Medical Officer, Anurag Relan, will also share some highlights of the approval and launch process for Joenja and an update on current plans and activities.

Thank you very much, ladies and gentlemen. It's my pleasure to start presenting the results presentation from 2022. Let's first show you the business model, what the strategy for the company is, and that has not changed for a while. You see it projected here. We are -- as we have acquired commercialization capabilities with the repurchase of the North American rights for RUCONEST in the beginning of 2017, we have acquired the skill to commercialize. And that's a very important skill in addition to, of course, being able to successfully develop and get medicines approved, which was, of course, the original skills that we had in the company. Hence, we are after building a sustainable rare disease business because disease business commercialization is a very special way of commercializing. We are therefore grateful that we have in our product, RUCONEST, which comes, of course, as you all know, from our own technology platform. We are very grateful that we have a wonderful sustainable business in the form of RUCONEST that generates, as you all know, more than $200 million during 2022 and provides a strong positive cash flow from which, as you have seen from the results, we were able to fund the preparations during 2022 for the launch of Joenja in the United States and the preparations for commercialization of Joenja beyond the United States. Also, further pipeline developments can be financed from that, and that's exactly the basis upon which our company's currently operating. That, of course, brings us to the second pillar, and that allows us to basically also invest, and we have successfully done that so far as well. And we'll continue to do so, the successful commercialization of Joenja in the United States and further on after approval in, for instance, the European Union, but also countries in the Middle East and North Africa and, of course, in the future towards Japan. And last but not least, the plans for Joenja to develop it for subsequent indications because that is what -- the good news is, of course, if you get a compound from a company like Novartis in license, that a lot of research work has been done in various applications -- potential applications of Joenja. That is certainly what we will start pursuing and you will hear more about that in the near future. In addition to that, the commercialization infrastructure that we have is very nice. It is scalable. As you have also seen from the extension of the commercialization infrastructure in the U.S., that was only a minor extension compared to what we already had and what we need to commercialize RUCONEST. Hence, why we have capacity for more products, and that is actually where we are after as well. We are actively looking for additional in-licensing opportunities or acquisitions of new products, albeit that given the strength that we have in clinical development and regulatory affairs, we look for products that are, of course, in advanced stage of clinical development, i.e., a so-called product -- so-called clinical proof of concept. So we are not investing at this point in time in products that do not have that are so-called early stage of development because that, at this point in time, is not within our strategy. And therefore, we are very active, as I said, in the market to actually fill that capacity that we have in the commercialization infrastructure to find new assets. And here, you see the pipeline, of course, as this is represented today, you see there very clearly that, of course, Joenja has made a big mark in our company's history as Paul was already referring to because we're now not only depending on one product but on 2 products for our revenues. And of course, with the ambition of bringing Joenja into the European Union and in the United Kingdom, we will also extend the business significantly beyond the United States. So going forward, we're looking at the company building on 2 products and more than one geography because at this point in time, of course, the vast majority of the business comes from the United States. You also see on the pipeline here, the additional development of leniolisib for pediatrics, first, the older children and the younger children. And of course, the possibility to bring Joenja to the Japanese market, where we will have -- where we have reached an agreement with the Japanese authorities for a relatively small clinical trial to do in Japan before we can actually hand in the file. And more news about that, of course, in the very near future. And you see the first signs here of the further geographic expansion that we are planning, namely the plans that we have to actually hand in the product files to Canada, respectively, Australia. And we expect to be there in those 2 markets in the not-too-distant future as well. And as I was already alluding to, the good news is you have a compound from a company like Novartis that you have in license that a lot of research work has been done. And we are making up the priorities in which of the subsequent indications of Joenja, we will start investing. And as you know -- may well know from our previous press releases, we look forward to updating you on that in the second half of this year as and when we have made the decision. And last but not least, you see there our commitment to hereditary angioedema population. That is the project OTL-105, where we in-licensed the HAE gene therapy, and we're looking for a potential cure for hereditary angioedema patients. That is, of course, still in early stages as we look there to actually bring a preclinical proof of concept to bear in the collaboration with Orchard Therapeutics, upon which we will then start. If that is successful, we will then start with the so-called IND-enabling studies. So -- but that's a real early-stage compound. And as you can see, therefore, there is ample capacity in the commercialization infrastructure to bring more products between OTL-105 and leniolisib. And that brings me to the next topic on the agenda. It is an important aspect. That is the ESG. So we took also here significant steps in 2022 to further define our environmental, social and governance or in short, the ESG strategy. As you are aware, our company's ESG performance is considered to be a good indicator of future success, business resilience and overall company health. Pharming does not view ESG purely as an obligatory regulatory requirement, but rather has chosen to focus on embedding ESG in our mission and strategy. We will, therefore, use ESG to further enhance and build a sustainable business while recognizing our impact on the environment and the role we play in society. Accordingly, we will integrate ESG priority topics for Pharming in our overall strategy, further defining an ambition level in each of these topics while simultaneously defining value drivers and related KPIs. We expect to complete that exercise during this year. To support our efforts, we launched an ESG program and created an internal ESG Steering Committee, of which 3 of the 4 presiding members are part of the Executive Committee to oversee the daily management and the implementation of the ESG teams in a holistic way. An ESG program manager was appointed and a task force was assembled from all relevant departments within the company. Overall support is delivered by an external consultant. During 2022, we performed a baseline and benchmark analysis and also completed a stakeholder analysis to better pinpoint where Pharming is in its [indiscernible] strategy. All this importance -- all this provide important insights into the ESG topics that are relevant for Pharming, while linking to the broader ESG landscape for our industry and the ESG performance of our peers. A materiality assessment was another important first step in prioritizing our ESG topics. In parallel, we began our first mandatory ESG report in accordance with the requirements of the European Corporate Sustainability reporting directive. Pharming is required to start ESG reporting metrics over 2025 and onwards. And currently, we remain on track to meet the schedule. In our annual report, the Chapter ESG has therefore been included, which provides an outline of the existing plans, activities and initiatives linked to each of the components of ESG. We will keep you obviously updated on further progress during 2023. And now I'll switch to the base pillar and main value driver, of course, of our business, and the only value drivers during 2022, of course, RUCONEST. We are very proud, as I said before, that we have been able to bring RUCONEST back to growth during 2022, plus 3% over 2021, in a market that is fiercely competed between ever new prophylactic therapies and, of course, a lot of other therapies that are being offered also on the -- in the acute area. But RUCONEST remains a unique product, because it's the only recombinant treatment that targets the root cause for this disease, namely that is the dysfunctional missing C1 [indiscernible] inhibitor that these patients suffer from. And that means that you actually work on all the pathways. And my colleague, Anurag Relan, our Chief Medical Officer, will show you the science behind this. But it means that it takes a -- continues to take a unique position in the market. And as you can see from the numbers of efficacy and reliability, this is really a product where patients can rely on. That means that in the beginning, when we came to the market, we were suffering very severely affected patients with hereditary angioedema. In the meanwhile, the good news for these patients is that a lot of new prophylactic therapies have come on the market, and the perspectives of these patients have improved. However, all of these patients -- that is because of the working mechanism of the majority of the prophylactic therapies, all of these patients can suffer at any point in time from the so-called breakthrough attacks. And these are dangerous -- potentially dangerous. So it means that all of these patients always will have an acute medication at hands at all time to be able to actually inject in the case of RUCONEST themselves, with a shot of RUCONEST if they feel an attack like coming. And these patients are trained, these patients are helped and trained to actually self-inject those dose and the vast majority do that on the spot when they feel the attack coming. And that is where RUCONEST acts as a unique position. And that is why RUCONEST for our company will remain a very stable source of business for the foreseeable future, because that is also the fact that the exclusivity on RUCONEST will expire in 2026. Yes, that is correct. You're thinking, "Wow, that's a very short life for this product." It is not, because RUCONEST is very difficult to produce. And if you want to produce a biosimilar product of RUCONEST, you will have to start a transgenic rabbit production system. And that is not something you do very likely. And the combination of the relatively small size that RUCONEST has, yes, EUR 200 million is a relatively small product in the pharmaceutical landscape, and the fact that it is so complicated to do this will make us believe that there will be no generic competition, or biosimilar competition is a better word to use, for RUCONEST in the nearby future. Hence, it is why RUCONEST, because of its unique mode of action, because of its unique position for those patients, and because of the unique manufacturing system that RUCONEST needs to actually be produced that we will see a very long life continued for this asset. And that is why we are confident that we will -- we can rely on the cash flows from RUCONEST for the foreseeable years and that we can continue to build on our strategy to build this sustainable rare disease business. So that is our business model for you. And I will now like to hand over to my colleague, Anurag Relan, who is in the United States, our Chief Medical Officer, to give you more insight in the science behind RUCONEST, first of all, with a slide and then take you through the news about Joenja and talk to you about the background of the disease as well. Thank you.

Thank you, Sijmen. And as we see on this slide, HAE is caused by an interaction amongst numerous pathways that lead to the production of Bradykinin, down on the bottom of the slide. And it's really these complex interplay of these pathways that illustrate what the point that Sijmen made is why there's an underlying continued need for a product like RUCONEST. There has been significant advances in the past 10 years, 15 years over understanding HAE and new products to help address these different parts of the pathway. But fundamentally, HAE is a C1 inhibitor deficiency disease. And you can see here the numerous red boxes where C1 inhibitor acts to interrupt these pathways. And again, these pathways are interconnected. So stopping one aspect of the pathway doesn't necessarily address the other aspects. And this is why we believe that there is a continued need for a product like RUCONEST that is a C1 inhibitor product that acts immediately. It's 100% bioavailable. It's immediately bioavailable. And I think that illustrates why we continue to believe that this is a sustainable business with RUCONEST. Now turning on to the next slide, we can see a little bit about APDS. APDS is caused by a genetic defect that leads to the hyperactivity of this PI3K delta pathway inside the cell. As a result of that hyperactivity, the B and T cells of the immune system do not develop properly. And because they don't develop properly, this leads to an imbalance in the immune system. And specifically, you have cells that are both, immature and not functional. And because they're not functional, you have problems with recurrent infections, and you see that on the right, but you also have this problem where the lymph nodes and other lymph organs overgrow and you get lymphoproliferation or enlarged spleen or liver or other lymphoid tissue throughout the bottom. But because of the imbalance, you also have problems with what's called autoimmunity and enteropathy. And in this instance, it's really this disregulation of the immune system that causes these problems. Because of these disregulated features as well as the infections, patients can also develop a serious irreversible process in their lungs called bronchiectasis. And the most feared complication of APDS is lymphoma, which develops unfortunately in a significant proportion of these patients. Next slide. And as you can imagine, given all of those different aspects of the body where APDS acts and causes consequences, there's many impacts on these patients' lives. Of course, there's the physical manifestations, which we saw in the previous slide, including the frequent infections, swollen glands and the whole list of symptoms that you see there on the top left. But there's also all of the other impacts on these patients' lives. There's social aspects that are not able to often go to school or work, or they're engaging their usual daily activities. There's a significant treatment burden from the therapies that are applied for these patients to the frequent hospitalizations due to infections and other procedures that need to be done. And of course, there are numerous doctor visits because of these therapies that are applied. All of this together has a significant impact on these patients' quality of life and their mental health. Next slide. Joenja, now approved in the U.S. by FDA, is an immune modulator that targets the root cause of APDS. And by binding to this subunit complex of the PI3K delta enzyme, it leads to a balanced pathway activation, so that there is no longer this hyperactivity inside the cell and so that the immune system can now develop properly. And what that means is that you have a proper balance of both, immature cells as well as functional cells. And we've seen that in the clinical trials. Next slide. With this, we have a significant advancement in the field of APDS for these patients and a significant opportunity to help these patients for Pharming. As you see on the top left, this is the indication statement for Joenja. It's a medication that's used to treat APDS in adult and pediatric patients who are 12 years of age and older. This indication and this approval was supported by data on the randomized controlled trial, where Joenja met both primary endpoints. We also saw improvement in other endpoints and other secondary exploratory parameters. On the safety side, there were no drug-related serious adverse events or study withdrawals due to Joenja in the clinical trial program. Importantly, we also have long-term data with the use of Joenja. And we have data now going out several years in many patients, including data showing a reduction in infections and a reduction in the use of what's called IRT or immune globulin replacement therapy. All of these data demonstrate consistent results that include the consistent safety that was seen in the double-blind placebo-controlled study, but also consistent and durable efficacy that we see in terms of some of the hallmarks of the disease, specifically the winter proliferation or the solar lymph nodes as well as some of the other markers of the immune cell function, including what are called naive B cells and levels of the IgM antibody. With this, and we are well positioned to hit the ground running with Joenja. And I think you've seen already from the results that we reported last week in terms of getting Joenja to patients quickly. And now looking ahead, we have, of course, launched the product and providing it already to patients as of last month. On top of that, we are in the process of finalizing our submission to the European authorities. And we expect that an opinion from their review will be provided in the second half of the year with the potential approval 2 months later. With the U.K., we also expect to be able to file in the second half of this year. Coming up soon, we're expecting to begin, as Sijmen mentioned, a study in Japan to be able to support the filing there of Joenja for adult and adolescent patients. And then there were -- we have 2 studies that we're developing, Joenja for both, in pediatrics; one is in the older population of children 4 to 11 years of age, and this study has already begun; and later this year, we'll be starting a second pediatric study and even younger children, because we recognize that this is a genetic disease, it's a progressive disease. It's a serious disease and the ability to be able to intervene and interrupt the progression of this disease at an early age is important. Next slide. And with that, I turn it over to my colleague, Jeroen Wakkerman, to review our financials.

Yes. Thank you very much, Anurag. And ladies and gentlemen, I'm very happy to provide you some color on the financial results of 2022. The revenues in 2022 grew by 3.4% from EUR 199 million to EUR 205.6 million, and that is in line with the single-digit growth guidance that we've given over the year. Gross profit increased by 5.8% to $188 million, and we improved our gross margin. Operating cost increased by EUR 17.6 million to EUR 184 million, which is an increase of 10.5%. And that was mainly driven by the investments in leniolisib or Joenja. Operating profit increased from EUR 13.6 million to EUR 18.2 million, and the net profit decreased from EUR 16 million to EUR 13.7 million. So overall Pharming grew the sales, and we also grew the investments in leniolisib. That's the very short of it. If we look at the several elements of the profit and loss accounts, starting with the revenue. As I said, we grew the revenues by 3.4%, mainly driven by the U.S. U.S. grew by 3% and in Europe, the sales were fairly stable. The increase in the U.S. was supported by a price increase, which was below the CPI inflation index and also supported by an increase in the number of doctors prescribing RUCONEST and an increase in the number of patients. Moving to gross profit and other income. Gross profit increased, and the gross margin increased from 89% to 91%. That was because of favorable production results and also because of an inventory impairment in the year before in 2021. And you see the big blue block, the other income, and that includes R&D grants and they are fairly stable over the years. And in 2022, we had a profit here, profit on disposal from the transaction related to BioConnection. BioConnecton is our fill and finish production partner. And we reduced our minority stake in BioConnecton from 44% to 23% of the shares. And the profit on disposal was EUR 12.2 million, and that is included in this EUR 14.5 million you see on the graph. Operating costs increased from EUR 166.8 million to EUR 184.4 million. And I made a split here in normal operating costs and leniolisib out-of-pocket costs. And you see that the leniolisib out-of-pocket cost, there is anything not related to payroll and normal cost increased from EUR 17.6 million to EUR 33.9 million. So that's a big driver of the increase in the cost, and it's almost a doubling of the cost of leniolisib versus the previous year. And looking at the cost category development. So it's the same numbers in total, but just a different split of those numbers. R&D went from EUR 70 million to EUR 53 million in '22. And that was because in '21, we had a big one-off related to OTL-105 that was just referred to by Sijmen. So on a like-for-like basis, if you compare 2021 to 2022, the R&D costs, they are fairly stable. G&A cost, that is general and admin costs went up from EUR 37 million to EUR 46 million. And that is a combination of additional payroll costs, additional IT costs, compliance costs and impairment. You see the biggest increase in the cost driver is M&S costs. Marketing and sales went from EUR 59 million to almost EUR 86 million. And that is -- the increase is mostly led by the leniolisib cost increase. These marketing and sales costs are mainly related last year to market access costs and marketing efforts. The operating profit went up to EUR 18.2 million. So that was driven by the increase in the gross profit, the profit on disposal from BioConnecton transaction and offset by higher cost due to leniolisib. Net profit went down from EUR 16 million to almost EUR 14 million. And that was mainly related because of the finance results and within that, that was mainly the foreign exchange effect. And similar -- same data from a different lens, profit before tax compared in 2022 to 2021. Starting off with the profit before tax in 2021 was EUR 23.1 million on the left-hand side. In 2021, we had a few one-offs that I mentioned, so OTL-105 and the write-off that was in total about EUR 20 million. So you could argue that the like-for-like profit before tax in 2021 was a sum of the 2 amounts, so that's about EUR 43 million. So what happened in -- to come to EUR 15 million profit before tax in 2022? Obviously, we had the growth in gross profit that I just mentioned. We increased our R&D expenditure, mainly from leniolisib. We increased our G&A expenditure, as I just mentioned. And mainly, we increased our marketing and sales expenditure. We saw the profit from BioConnecton coming in. We had a decrease in financial results and overall, profit before tax was EUR 15 million. I'm saying profit before tax here. The good news is that the profit on disposal from the BioConnection transaction was tax exempt. And the result of that was that our effective tax rate in 2022 was relatively low at 8.8%, whereas the year before it was 31%. Moving from the P&L to cash flow. We started the year with a cash position of $191.9 million. We ended the year with $207.3 million. So an increase of USD 15.4 million. What drove the change? Well, first of all, and mostly, it's the cash generated from operating activities. It's mainly operating profit, because the working capital was fairly stable during the year. We generated cash flow from investing activity, and that's again, it's the BioConnection transaction. Cash impact there was different to the profit impact. That was $7 million positive. And we spent just over $2 million on investments in CapEx. So think about property, equipment and software. We used cash flow in financing activity, the $5 million. That's just a regular interest on the convertible bond that we have outstanding and regular lease costs. We had negative exchange rate effects. And hence, we ended up the year with a very positive $207 million cash position. Looking at this year, 2023, what is the outlook? We continue the guidance of a low single-digit growth in RUCONEST revenues. We had the approval on the 24th of March of Joenja by the FDA in the U.S., and we started launching and commercializing in April 2023. In the UA -- EU, sorry, we expect a positive CHMP opinion from the EMA in the second half of this year and the marketing authorization to follow 2 months later. In the U.K., we will file leniolisib with the U.K. authorities, and that is subject to the positive outcome of the EMA CHMP review. We will continue to invest in -- to accelerate our future growth. So that will be mainly in research and development and marketing and sales cost in leniolisib. So that's both, for the launch but also for additional indications on leniolisib. And we will provide further detail on the plans to develop leniolisib in additional indications in the second half of this year. And we will continue to focus on potential investments in acquisitions and in-licensing of late-stage opportunities in rare diseases, as Sijmen mentioned as well. So overall, 2022 could be summarized as a good financial year. We saw sales growth, an increase in operating profit, good cash generation and a cash balance in excess of $200 million. And for 2023, obviously, the year -- this is the year of leniolisib and Joenja. And we are very pleased with the first sales results of Joenja in 2023. That was a summary of this year's financial results. Thank you very much.

Thank you, Sijmen and Anurag and Jeroen. And now I'd like to invite our shareholders in the room to ask their questions regarding this agenda item. Please go to one of the microphones for that. As mentioned during my opening remarks, please state your name and, if applicable, the name of the shareholder that you represent before asking the first question. And please don't ask more than 3 questions at the same time. Are there any questions?

Yes, one question. I'm [indiscernible]. I'm speaking in Dutch. [Interpreted] So I thought, Jeroen, you were going to present the second quarter figures because there were some great numbers there. But I understood that the comma had to shift 3 places. I was a little bit disappointed. I thought you were going to present the 2 quarter -- second quarter segments, but it was from 2022. There were millions, but there was a lot of numbers. So the future of Pharming, you had 2 slides about the numbers, and there were lots of numbers on there. Only then did you get the comma and then millions. You didn't notice? No one gets it? Now that it was different on the screen than it was on the print. So also, we all saw something else, but it wasn't the second quarter figures. That's a shame. Beyond that, it was great. It was clear.

[indiscernible] speaking on behalf of [ VEB ]. First, congratulations. I'm happy to see this state which Pharming has been able to achieve in many, many years. We've got actually 2 points for this agenda item. The first one already [indiscernible] elaborated on. And I'm actually curious how long the cash flow from RUCONEST can last. And of course, the 2 parameters which influenced that one. The first one, and I don't have any knowledge about that, is a competitive landscape. So are you aware of any rumors that somebody may be inventing something which may be as powerful or even better than what RUCONEST is doing? And if so, how many more years would it take for that kind of competitive product to come on the market? That's question number one. I hope that there's nothing happening in the next 5 to 10 years. Secondly, that's connected to that one, assuming that the market remains more or less like it is, where you're also even benefiting from the preventive competition that despite the patients are taking this kind of medication, they still may need RUCONEST from time to time. So that's good news for shareholders, not good news for the patients maybe, but for us, it's very good news. I'm wondering if there's any kind of upward potential as far as pricing is concerned? And we all know that a lot of criticism coming from lots of governments and patients and hospitals and so on, about pricing. Also in the U.S., even though prices are very, very high there, but what degree do we have opportunity to increase prices 1 year to the other one? So that's the cash flow part. The second question, I think, is much more interesting. I admire the creativity you've managed to create in trying to find the leftovers of the big companies and really make this as something valuable for Pharming because actually that is the truth. The big pharma, they are not interested in products which generate $100 million or $200 million a year. It's not relevant for them at all. Could you maybe explain to me how easy it is to find those kind of leftovers and how many small players like Pharming are fighting about those leftovers? So is it realistic to be very, very practical? Is it realistic to assume that in 2, 3 or 4 years from now, Pharming may have got 4 or 5 of these kind of things like Joenja in the portfolio? Those are my 2 topics, Mr. Chairman.

It's always very nice to see you here again. You memorized that already. Yes, with regards to your first question about the competition in the hereditary angioedema market, as it was hopefully made clear by this wonderful slide that Anurag Relan presented, we are the only protein replacement therapy on the market, because nobody can make recombinant C1 esterase inhibitor. There has been, of course, a lot of innovation that's good for the patients to actually cover 1 of these 3 pathways that you see on that slide. That means, however, that there's nothing new on the horizon with regards to any of the development -- any of the products that are coming. And by the way, we keep a very good -- keep them very well on our radar screen. We know them very well. And obviously, we're potentially even interested in any of those products, should they be good, right? Because we are a commercialization company, and those companies are far earlier stage of development. That's one remark. Secondly, there's nothing new on the horizon, as I said. They all are covering that one pathway, and there is, therefore, the breakthrough attack or the nonresponse in case if you have an acute medication. It's well-known, patient research, and this is from some of these companies do that patient research, and you can clearly see all the time when you ask patients, would you be able -- would you be willing to actually trade efficacy for convenience? And in prophylaxis therapy, there is some extent of that. And therefore, you see for instance, the oral prophylaxis therapies have more breakthrough attacks, but it's much more convenient. However, in acute medication, there's no such willingness of those patients. And as you saw from the results of the RUCONEST efficacy and reliability, it can hardly come any closer to 100%. So therefore, it means that RUCONEST will continue to have that new space. That's a unique niche, if you were, because we're a relatively small player in this market. It has that unique niche in the market, and we'll continue to have that. Now whether there will be any inventions in towards the future, of course, that will cure, we are working on our own version. That will be quite a few years down the line before that happens. There is some other alternatives going on in that respect as well, but they are also quite far from the market away. So therefore, a combination of that, that there is a lack, in fact, of something new apart from those [indiscernible] horizon gene therapy approaches is -- and the fact that RUCONEST cannot be produced in any other way -- sorry, C1 -- recombinant C1 esterase inhibitor cannot be produced in any other way than with the pump makes us believe that the revenue stream for RUCONEST will continue to go on for quite a few more years. Now is that 5 or 10 years? That's difficult to say here. Is that going to be a product that's currently $200 million and will grow to $250 million or reduced to $150 million? I'm just throwing out some numbers here with your approval. That, we don't know, of course. But there is a niche in that market that continues to be served. And you heard also from my colleagues that we take also strength from the fact that more and more doctors prescribe RUCONEST. And more and more patients are using RUCONEST, also because that paradigm towards that [indiscernible] inhibition is slowly moving the realization of people that it is for -- it's very rational to use that C1 inhibitor as breakthrough medication.

If I may interrupt. I'm trying to listen very carefully to you. What I do not understand from your story is that there would be any kind of scenario based on what you've just explained that the revenue from RUCONEST would drop to $150 million.

No, nor do I, but I'm just...

But you say, for instance, that I don't understand but I do understand $250 million or $300 million step-by-step inflation increase or whatever. But $150 million, that means something new would happen in the market.

No, no, no. If something drastic would happen, a product like that would, of course, go down probably even further. But I'm just giving you a range that we do not know that, of course. But we see at least that this business is a sustainable business. And whether it will grow to $250 million or whether it will decline slowly to $150 million, that we don't know, of course, because there's always people that change behaviors. And it is a complex market. Like I said, patients should always have more than one medication in their hands. That's why it's also very difficult to model this. But no, we do not expect that at all. And the future is an innovative industry as this is very difficult to predict. So they can, of course, come development. But for the foreseeable years, we don't see that. That is with regards to the competitive landscape. Then with regards to the pricing landscape in the United States, as you heard mentioning, we have increased the price below the cost of living index over the last few years. All industries do that. That is normal in the United States. We also do that as well. And at this point in time, going forward, we expect that this will continue to be taking place unless there's a drastic policy change in the United States market. And the United States market is very different than the European markets. It's very fragmented as well. There is government-funded patients that are Medicare and Medicaid who get a mandatory rebate, by the way, on the published price of all products, all pharmaceutical products. And there is, of course, private insurance companies who pay the full price. That has always been the case. We expect that, that used to be the case. Excessive price increases are no longer happening in the United States. That is definitely not the case anymore, and it was in the past, of course, sometimes occasion, sometimes very, very high increases in prices, but that's no longer the case. So price increases below the cost or around the cost of living index is in the model. So therefore, from that perspective, you're absolutely right. A product like RUCONEST could slowly grow in its revenues going forward. I hope that answered that question as well. Then with regards to your questions about Joenja and leniolisib, how easy is it to new assets? Well, our business development group is a small group. It is a very efficient group. They have looked at about 150 of these opportunities over the last year. So they're very active. Now the majority of those do not require any further analysis. So they've been kept -- they are -- that's the next stage. Then we have a committee in the company that looks at it in the next stage. There, let's say, a small amount -- a relatively small amount comes further. And we've also gone into due diligence -- technical due diligence with a couple of those opportunities during the year. That's the typical filter that you see in the business development, whether you are in Novartis business development or whether you're here. This is a typical funnel that you actually see. And that actually -- that applies to us as well. So in other words, it is not easy to find something. It's a lot of leg work, as we call it, in big companies like Novartis, where Paul and I used to work together more than 20 years ago. Paul had a whole army of people going around and visiting all the biotech companies in the United States, and we were trying to find products like that. But that, of course, that luxury we don't have. However, you heard already, 150 opportunities we looked at.

Are there many competitors similar to Pharming that are fighting with the leftovers?

There are.

It sounds more negatively than it really should but...

Yes and no. Yes, there's many companies who had -- who aspire to become a sustainable rare disease company as well. However, what we are doing at Pharming in a way is also quite unique, because we differentiate ourselves from most of our American peers, for instance, because we have commercialization capabilities in Europe, outside of Europe, in the near future in Japan and in the United States. And we differentiate ourselves from the European competitors, most of them that we also -- for the same reasons as well because they probably -- or in most cases, have either no capabilities yet or have only small capabilities. In that respect, I think we have more of an advantage in this case. And certainly, as we go forward, and that is the great thing about Joenja, because it will basically help us to not be able to only be dependent on this geography, but also make us a more an attractive partner of choice. Lastly, of course, if we make a success out of a product like Joenja, we're in the good books of a company like Novartis, for instance. And they prefer to work with partners that's basically have done a good job already for them. It's not to say that we're the first ones to be called, but it is, you move up on the list. And equally, of course, this radiates as well. And when we talk to other companies, big pharmaceutical companies where we also have on a regular basis from time to time in discussions about what they have, where you then show up on the list and not totally at the bottom of the list but also move. So it's a -- it is, as we were already alluding to, it has been a patient game to come here today to reach what we have reached today. We need a lot more patients going forward. We are on a good stretch, and we are certainly not without chances to get on a regular basis. And that's our aspiration to launch on a regular basis new products in those rare disease arenas to further leverage our commercialization capabilities.

I'm [indiscernible]. I have 2 questions. First off, Joenja, is there any qualification in respect of the revenues to be gained this year?

I can answer that question very quickly. There's analysts who, of course, give predictions for that and the various banks that cover us. And I would recommend you read the analyst reports because we don't give any guidance on that yet. We also think it's too early days, of course, to do that. In the future, we may actually start giving more guidance or not, but not for this year yet. But I would like you to -- refer you to the various analyst reports that have been written about this, both, for the targets that they see reachable for this year as well as the peak sales levels that they predict for the future for Joenja.

O'm a little bit disappointed, Sijmen. Yes, because you are the first one to -- yes, you guys are the first one to ask that and not the analysts.

The analysts are the experts, right?

Yes. I have another question, yes? I was very disappointed by stopping the pipeline of RUCONEST. Now I was wondering what causes that?

Yes, you're referring to the announcements last year. We came to the conclusion that when we started this project on the subsequent indication for RUCONEST. As you well remember, that had to be also in conjunction with switching platform from rabbit to cattle because of those large volumes of indications. So when we set off to do these clinical trials, we only had, of course, the rabbit product available, and we started to do the clinical trials, for instance, in AKI. And we had some interesting results. We started the second trial for that because of those interesting results. But the whole hypothesis of this was based upon the fact that under normal circumstances, we could use bridging studies to go from the rabbit platform to the cattle platform. That means that you can actually use -- you can -- the results that you've updated your clinical trial for the rabbit platform are valid more or less for -- to switch over to the other platform. Now unfortunately, we had extensive discussions with the regulators, like for instance, the FDA. And they told us in no uncertain terms -- and EMA, and they told us in no uncertain terms there was no chance that they would accept that. Probably has to do with the fact that transgenic platform is not very well known to the regulators, but they had no intention to take that risk and to allow us. So in other words, we had to go despite the fact having good clinical results in Phase II, for instance, in AKI. If we would have had that, we would have gone back all the way to the very beginning as if there was a totally new product and had to start from scratch. That meant that the products, if they were successful, could not be introduced until 2032 or something like that. And that means you throw a lot of money at uncertain projects. And you start from scratch where you have a lot of chance to fail. And we decided that apart from the fact that these trials and these bigger indications will be very, very expensive, we decided that an opportunity like Joenja would give us a lot quicker payback and return on investment and continue to invest a lot of money in that. And therefore, we decided to change the strategy during the last year into that specifically focused on rare disease strategy that we were already hinting towards, but now we have basically fully dedicated us to that. So it's really about faster growing the company and leveraging the capabilities that we have.

Regretfully, it wasn't mentioned by discontinuation.

Congratulations on the approval of Joenja for U.S. market. I have a question on the profit per share, the development of this. Last few years, nice revenue for RUCONEST. What we see is -- what we maybe could expect is a few cents on profit. And we see a small profit over the year because of the one-off cost impairments and other things. What is your expectation of the profit for RUCONEST? Will it be like $0.05 in the future or cost savings because of the R&D?

Maybe I can generally answer that question. At this point in time, as Jeroen is already also outlining for the guidance and as you can see from the numbers, we are really not focusing on short-term profit optimization. That must be clear to everybody. That is not what you should expect. Pharming became, all of a sudden, very profitable, of course, with the buyback of the North American rights. But then you can also see that the profits were going down. And that's, of course, because we are investing in accelerating the growth in the product like Joenja. And if we in-license more products or acquire more products, those investments really again increase. However, they can be borne by the cash flows from RUCONEST and of course, the expected future cash flows from Joenja. That's the business model. So we are working on long-term growth and acceleration of the growth and not on short-term profit optimization. So I'm afraid unless you want to [ wait on that run ], I can't give you any sort of predictions on how many cents RUCONEST will actually bring for profit. Do you want to comment on that, Jeroen?

No, I would agree to that. It's -- we are not focusing on short-term profit. And for now, we are investing, as you've seen in the 2022 results builds on '21 on the launch of Joenja. In '23, that will continue. That's also the guidance that we've given before. And the benefits will, yes, come after them.

These investments are likely to be larger than the savings with stopping products in the pipeline?

Sorry?

Stopping the research should bring some savings?

Yes.

But you are expecting the investments to be larger than the savings for...

Yes. What I've just shown is if you look at the R&D costs for '22 versus '21, on a like-for-like basis without all the exceptions, it's fairly stable. And why is that? We have invested a lot more in leniolisib in R&D. But indeed, as you say, the -- we reduced the investments in AKI, in Pompe and the -- basically the transgenic platform R&D. So it balances out. But within there, there's a mix towards leniolisib and less on the transgenic platform.

Okay. Then a question on merchant acquisitions. The process, Pharming would like in-licensing product in -- or, let's say, it's opportunity as it says on the sheet. Are you also looking at acquiring a company? So I'm looking for the risk level Pharming is seeking here. Leniolisib was about $20 million. The money is in the bank. It has still effect on the profit. Are you also looking at hundreds of millions of acquisitions or...

The preferred way to do this, of course, is in-licensing. It's much easier for a company like ours. But there could also be a possibility where there is no such choice of in-licensing because that company only has one asset. And actually, the only way to get it is to acquire that company. That is, of course, not impossible. And of course, that will mean that there will be a lot more investment. But that will, of course, mean that we have to organize probably a shareholder meeting to actually get the approval from the shareholders for that. But in all, I think we can summarize it. The preferred way to do this is in-license compound. And if not possible, then we will have to do an acquisition.

And what were the comments on the [indiscernible] was skipped? What were the comments of the investors?

There were no comments, but the so-called proxy advisers have certain policies. Certain policies are associated with the market where you operate. And so the country where you operate or, in this case, the European area where operate. And they have a very strong opinion that companies should not have more than 10% of the shares at the disposal to actually use for investments. That includes, of course, for share-based compensation. So then there's only probably 7% left that we can actually do without that second authorization. We were kind of surprised, because we know that there was, of course, in the past, that policy has already existed. But in previous years, 2/3 majorities were obtained to actually get this second 10%, and we think that's very important because it will be helpful if we can do small acquisitions, which we prefer to do very quickly without having to organize an AGM with 6 weeks' notice. But unfortunately, that is not the case. Therefore, we will research and try to find out what has changed this year. And of course, we'll basically think about this and about next steps.

All right. Last question on the U.S. listing. If you're looking for a product in-licensing, is the listing still necessary? Or does it bring a lot of costs, some regulation to keep it up, the company?

Yes, it does. And it's always hindsight, of course, but yes, we did it for a certain reason, namely to have that currency of ADRs available in case we have to do an acquisition. I think still that's still valid. Yes, there's cost associated with it. But on the other hand, the company needed to come into better and improved compliance anyway because it's growing. So yes, it's not funny to actually do the Sarbanes-Oxley compliance, but it is a necessity, I think. And we're working on it towards becoming compliant with Sarbanes-Oxley. And yes, it costs money. But again, if there is an opportunity that comes, you have very little time, and it's much easier if you have already have a listing and just have to upgrade the listing to a Level 3 whereby you can actually do a fundraising on NASDAQ. And let me just also say that we're in a very fortunate position, of course, that we did never have to actually raise any funds and issue any shares since December 2016, when we acquired the commercialization rights for RUCONEST. And that's something that is, of course, unique, but it is -- also has a disadvantage because it means there's very limited liquidity at the moment as of NASDAQ listing.

Thank you very much. Let's move on and just -- we'll now also answer questions that were asked online. And I think I see there are no questions that have been asked online. So we will move on.

We'd now like to close agenda item 2A and ask that Steven Baert, the Chair of the Remuneration Committee, to present to you the remuneration report for the year 2022. This report is included in our annual report and on today's agenda as item 2b.

[Interpreted] Thank you, Paul, and good afternoon. I'd like to welcome you as well. Hand it over the chair of the Remuneration Committee to me. I would like on behalf of the committee thank Deb for an excellent job. And we were also very happy that she stayed on as a member of the Remuneration Committee. I would now like to present to you the remuneration report for the financial year 2022, which underwent significant changes in terms of the disclosures, as you may have noted. The Remuneration Committee considered all the feedback we received from the shareholders as well as from our proxy advisers and implemented changes accordingly. For example, we included retrospective disclosures of effectively all targets that had been agreed with the CEO for his 2022 short-term incentive plan but also for the testing of the shares granted in 2020 under the onetime transition arrangement. And so you will hear more about that soon. We also included the full outline of the performance measures and the weightings that have been agreed with the CEO for the 2023 short-term incentive. And we will, again, retrospectively disclose the achievements against these actual targets in the remuneration report next year. We have, however, identified a few targets that will not be disclosed, because they are commercially too sensitive. Last but not least, we went one step further for the long-term incentive plan, and we are already disclosing upfront all nonfinancial targets that will have to be satisfied by the CEO in the performance period between 2023 and 2025. We will continue to monitor the need for transparency for further changes to our remuneration design and disclosures to ensure that we deliver the highest level of transparency as required by our shareholders and proxy advisers. In the middle of 2022, the Remuneration Committee also engaged [indiscernible], an international compensation expert, for a market review of the compensation of both, the nonexecutive directors and the Executive Committee. I will come back in a few minutes in terms of the conclusions for the Executive Director, the CEO's remuneration package. Regarding the compensation of the nonexecutive directors, the Remuneration Committee concluded that the fees for the Board were aligned with the benchmark. However, the compensation for the Chair of the Board was concluded based on the data we received to be below the benchmark. And as you will hear later, in terms of chair transition, we will submit a proposal to our shareholders for a fee adjustment at the moment that we will be able to nominate the new chair to the Board. The fee levels of the chairs and the members of the respective committees of the Board Directors -- of the Board of Directors was also found to be below benchmark. We've seen that these fees went up significantly in other companies due to the increase in workload that now goes through these committees. As a result, we have started an additional review of the fee levels of the committee chairs and members. And once we have that information and the data, we may have to present a proposal for adjusting the fee levels to our shareholders during any of our future meetings. Let me now move to the CEO pay. Looking at the implementation of the remuneration policy in 2022. The Remuneration Committee, first of all, was pleased to note that Pharming had a positive year, as you've heard from Sijmen and Jeroen that growth in its existing portfolio and strong continued momentum behind RUCONEST but also the preparation of the launch of leniolisib earlier this year then received the FDA approval. Solid financial results were delivered that enabled the company to continue on its path for growth. And in doing so, Pharming continued to deliver on its mission and purpose of serving the unserved rare disease patients and becoming the rare disease company of choice. Translating therefore those results in the short-term incentive targets that have been set for the CEO for the year for 2022, the Remuneration Committee calculated a total score of 89%, within the range of 0 to 200% on all financial and nonfinancial targets. Within that, this included a 75% achievement score for the financial targets as the revenue target was not entirely met. However, the remuneration committee acknowledged that management under the CEO's leadership delivered on the additional goal to return the annual revenues to single-digit growth in 2022 compared to 2021, [ 3.3 ] growth in revenues was achieved. A summary of the results of 2022 for each of the 4 components of the short-term incentive plan is visible on the screen behind me. If you want more detail, I also invite you to read the detailed scorecards on all financial and nonfinancial targets. That can be found on Pages 109 up to Pages 111 of the annual report that you have in that beautiful pack behind you. According to the remuneration policy as adopted by all of you, our shareholders and on-target performance by the CEO would result in a payout in cash equal to 70% of the gross annual salary with a maximum payout of 140%. So if you now apply the 89% achievement score to the 70% on-target score, this resulted in a cash payment to the Executive Director equal to 62% of the fixed annual salary for 2022. Or the long-term incentive share plans in this year, none of the outstanding shares for the CEO were scheduled to vest. However, there was a one-off transition arrangement, which was agreed with the CEO in December 2020 to facilitate the implementation of a new performance-based long-term incentive plan and there, the third tranche and also the final tranche of shares granted under this arrangement vested on December 31, 2022. The vesting percentage here is based on the performance by the CEO in 2022 against 2 metrics. One is total shareholder return which accounts for 40% and strategic corporate objectives, which account for 60%. The Remuneration Committee concluded that the CEO had satisfied 90% out of a total of 100% of the corporate strategic objectives. Again, a detailed scorecard was included and can be found on Pages 113 and 114 of the annual report. On the total shareholder return compared to the AScX Index and the NASDAQ Biotechnology Index. This resulted in a vesting percentage of 115%. So applying the weighted percentages, this resulted in the vesting of 100% of the 1.4 million shares that had been granted for the third tranche. The CEO is required to retain these shares for a total period of 5 years as from the moment that these shares were granted early 2021. And as I mentioned earlier, the Remuneration Committee engaged AON Radford to do a market review for the compensation of the members of the Board, but of course, also the executive committee and therefore, the CEO. The Remuneration Committee concluded that the compensation level for the CEO is positioned in the upper 75th of the EU benchmark group. However, in the upper 25th of the U.S. benchmark. So compared that against revenues where we see that the benchmark data indicated that Pharming is currently positioned between the 50th and the 75th of the EU benchmark where for the U.S. benchmark Pharming is positioned just below the top 50 of the benchmark group. In light of these assessments, it was decided to increase the fixed salary of the Executive Director, so the CEO by 3.5% from EUR 603,000 to EUR 624,000 for 2023. This salary increase takes into consideration, of course, inflation, the solid performance by the CEO in 2022. The Remuneration Committee also took into account the average increase for Pharming employees in Europe in 2022 and that was 4.9%. So as such, the CEO received an increase below the average of the Pharming employees in Europe. More details on the CEO total remuneration package for 2023 can be found on Page 118 of the annual report. And so we can now move to any questions from our shareholders on compensation poll.

Thanks, Steven. I would now like to invite our other shareholders to ask their questions to Steven on this agenda item. Please go to one of the microphones and state your name. And again, if applicable, the name of the shareholder you represent before asking the first question. Are there any questions? Thanks, Steven. We will now answer any questions that were asked online and there are no questions online. We will now proceed with the voting on the remuneration report for the financial year 2022. In accordance with the European shareholder rights directive as implemented in Dutch Law, you are asked to cast an advisory vote. All votes in favor of the report mean that the remuneration report is appreciated and deemed positive. Any votes against the proposal are understood to imply that the report does not meet the expectations of these shareholders. The advisory vote will not be binding, but we will explain in next year's remuneration report how the vote of the general meeting was taken into account. As promised during my opening remarks, I will first explain the procedure for the voting during today's meeting. Prior to this meeting, we received proxies and voting instructions from several shareholders on the designated voting items on the agenda. All shareholders that are following the webcast and would like to vote also had to issue a proxy prior to this meeting. All proxies have been processed and verified by our civil law notary. Shareholders who are with us in this meeting room and who have not yet issued a proxy will be able to cast their vote on designated voting items during this meeting. The shareholders have received at the registration desk today, their personal login credentials to log into this meeting to cast their votes. Please raise your hand if you have not received these log-in details or if you are encountering any technical problems. Once I have opened the voting on any agenda item you are invited to press for, if you wish to vote in favor of the proposal; or to press against, if you would wish to vote against the proposal; or to press abstain, if you would wish not to vote. These votes will not be included when determining the voting result. You will be able to change your vote until the voting round has been closed by me. After each voting -- after each round of voting, the total number of votes cast and the final voting result will be shown on screen. This will be done by adding up all votes already received by means of proxy and the votes cast during this meeting. The civil law notary will monitor this. A total number of 1,026 shareholders and [ 92,034,877 ] shares is represented today and is entitled to vote on all items on the agenda. We will now proceed with the voting on agenda Item 2B, our shareholders are proposed to give a positive advice on the presented remuneration report for 2022. I've opened the voting, and please cast your votes now. [Voting]

I will now close the voting. The voting result will be shown on the screen in a few seconds. I am pleased to confirm that the proposal is supported by advisory vote by our shareholders with a 95.05% majority. The next item on the agenda is Agenda Item 2C on corporate governance. Sijmen, could you please introduce this item and also the subsequent agenda Item 2D for a summary of the dividend policy. We will address the questions of our shareholders on both sub items after your introduction.

Thank you, Paul. Agenda Item 2C has been included to update our shareholders and material developments in the field of corporate governance. As you are aware, our American depository shares have been listed on the NASDAQ stock market since 23 December 2020. Our ordinary shares have continued to trade on Euronext Amsterdam. Pharming continues to take all steps required to ensure compliance with the applicable U.S. regulatory requirements [indiscernible], as announced on 5 April 2023, Pharming filed at the same day its annual report for 2022 on Form 20-F with the U.S. Securities and Exchange Commission. You can find a document on our website. In addition, we've taken further significant steps in 2022 for implementing an enhanced internal control framework to ensure compliance by our company with U.S. Sarbanes-Oxley Act. On Page 65 and 66 of the annual report, you will find an outline of how Pharming has applied to the Dutch Corporate Governance Code in 2022. Slide that is now shown on the screen provides a summary of a few remaining deviations that are deemed consistent with the size and activities of our company. There are no material changes compared to our 2021 Annual Report. As for the dividend policy Item 2D, Pharming continues to follow its existing policy not to pay dividends -- board of Directors does not envisage the payment of dividends in the coming years. Payments of future dividends, if any, would be at the discretion of the Board, taking into account various factors, including business prospects, cash requirements for the business, financial performance and product development opportunities.

Thanks, Sijmen. We will now address the questions on corporate governance and our dividend policy. I'm now inviting our shareholders present today to ask their questions on corporate governance and on our dividend policy. Please go to one of the microphones in the room and mention your name. Again, if applicable, the name of the shareholder you represent before asking the first question, I would like to ask Sijmen to answer any of these questions. Are there any questions?

Yes. My name is Keyner. I speak on behalf of VEB. Mr. Chairman, I've got 2 elements, 2 points. The first one relates to kind of surprise, which you started the meeting with today that the voting of large number of investors or maybe a few big investors was surprising that they did not support one of the agenda points enough for you to continue with this agenda point. But I would like to go back to last year. At the end of last year, I was very surprised, and I think so were you that a large percentage of investors did not discharge the Board of Directors from liability. And I know in many cases, this is just symbolic, but it's more or less getting a yellow or red card, I remember it was 14%. 14%. Yes, exactly. So I ask you at the end of the meeting, wow, this is very surprising. So were you, you said. And ask you, well, maybe should investigate what happened. So I'm just asking for feedback. So what came out of your analysis? Sure. You want to know why some investors are not happy with you.

That's a very interesting question, Mr. Keyner. Unfortunately, of course, we have a -- as you well know, we have a lot of retail investors following. We are not aware of any big items with regards to the -- to any of the institutional shareholders that we know nor of the quite substantial numbers of long-term shareholders that are private shareholders, which we have very good contacts with as well and have organized themselves in the voluntary sort of group. And we were not aware of anything coming from that. So yes, we have -- we were surprised, you're absolutely right. And I think I'm not speculating on any of the voting today, but I hope today there will be a better thought. But if there would have been, of course, feedback from one of the institutional investors, we would have discussed that here.

Okay. Well, that's unfortunate. But in any way, I was surprised because I think you would have deserved to get the discharge. The second point is also a repeat of last year's question. Mr. De Vries has now been the CEO for at least 14 years. Difficult start, but in the end, it's getting more and more successful, and the sun is shining more and more. But I've got a question to the normal executives. How are you progressing in the succession planning at some point, even Mr. de Vries, he looks great. He looks young and full of energy. But even at some point, he may decide to stop. How is succession planning progressing?

And we're doing very well. As you've seen in the report, we now spend our time dedicating focusing to replace Paul as the Chair of our Board. At the same time, we're having a lot of conversations, both around what internal candidates do we have and what we will look for in the replacement of Sijmen. So it's clearly on the agenda and is regularly being discussed.

Do you already have at least some potential names. Or is it only a discussion? At some point, we need to find and maybe we already need to contact a headhunter that if the time arrives that this headhunter can start immediately? Or do you really have some internal candidates?

We don't have hard, firm names. What we've said is that we take the chair role first because we think it's very important to have the Board complete again. And then the next step is creating that firmness around the names of potential replacement of Sijmen as and when it's required.

Thank you very much. Thank you. We will now ask -- answer any questions that have been asked online. And there are no questions that have been asked online. So we will proceed with the next agenda item. The financial statements of 2022 as included in the agenda as Item 2E. Financial statements are included in the Annual Report. Financial statements were audited by our external auditor, Deloitte Accountants BV. In accordance with the assignment given by your General Meeting on 20th of May 2020. Deloitte has issued an unqualified auditor's report for the financial statements 2022. That can be found on Pages 210 up to and including Page 219 of the annual report. And I invite Ms. Ingrid Buitendijk, Partner at Deloitte to present the highlights and main findings that followed from the audit by Deloitte.

Welcome. I'm Ingrid Buitendijk. I'm audit partner with Deloitte, and I'm pleased to say that we finalized the audit of Pharming. And we have issued our unqualified auditor's report as of April 4. I will now highlight some of the main topics and items of our audit as you are used to in the last couple of years as well. We also, as part of our work on the annual report, of course, reviewed the management report prepared by the Board and management to determine whether it is complying with the requirements of Part 9, Book 2 of the Dutch Civil Code. Next to that, we have included in our auditor's opinion, the key audit matters that we identified for the Audit '22, which are the rebate accruals in the U.S. that's consistent also with last year. And also, we determined the transaction with BioConnection, as Jeroen referred to earlier as well to be a key audit matter. You can find the details of what we did and the conclusions in our auditor's report. Another area of our audit, which we have put more interest in, of course, is the launch of leniolisib and the preparations for that in 2022. Scope and the coverage of our audit. We have performed full scope audit procedures for the significant entities of Pharming, and we have performed analytical reviews for the other entities. As you can see, the audit coverage has been 99% of revenues and 98% of total assets of significantly high, I would say. Materiality was determined at $2.4 million. And for the components, we use the lower materiality level of $1.4 million. We have reported any misstatements in excess of $118,000 to the Audit Committee and management, of course. In terms of communication, we have had several calls and meetings with the Board of Directors, the Audit Committee and the Executive Board, and we have issued written communications being the audit plan, management letter and year-end report. Next slide, please. It's already there. I also wanted to highlight some other procedures that we did, of course, in relation to the audit which are also further detailed in our auditor's report. On compliance with laws and regulations. We have obtained sufficient and appropriate audit evidence regarding compliance with laws and regulations, which mainly relate to whether they have an impact on the financial statements, of course. We have been during the whole audit attentive to indications of any suspected noncompliance with laws and regulations. Again, we also conducted interviews with all relevant people, CEO, CFO, legal counsel, et cetera. We've read the minutes of the Board of Directors and Executive Committee meetings. And also, we looked specifically at the fraud risk of management override of controls, which is a presumed risk which we identify with every audit that we do. So we evaluated the design and implementation of relevant internal controls. And we also paid specific attention to certain elements like the processing and controls around journal entries, the significant management estimates, any significant transactions like, for example, the BioConnection transaction. And also, we have held fraud interviews with all the people relevant to our audit as mentioned here on the slide as well. We have evaluated disclosures prepared by management regarding fraud risk management estimates and uncertainties and also, we have evaluated Pharming's own fraud risk assessment framework, code of conduct, whistleblower policy and incident registration. Last but not least, of course, we have also evaluated the going concern assumption based on which the financial statements have been prepared, and we performed several procedures in order to do so like evaluating the reasonableness of the assumptions used by management, whether all relevant information that we were aware of was included in those assumptions. And also reviewing management's future outlook as part of those procedures. And with that, I would like to close my presentation. Happy to answer any questions.

Thank you, Ms. Buitendijk for your explanation. Are there any shareholders in the room that would like to ask any questions on this agenda item, please go to one of the microphones.

[ Keyner ] on behalf of VEB. Just one question. I understand very well that Pharming in the past decided that there was no need or urgency to have an internal audit department and this may still be the case, even though I think Pharming is becoming a more complicated company. Bigger distribution network, but also more risk here and there. It's more difficult to get controlled to keep control of the whole company. So my question to the auditor, to the external auditor is, to what degree does the fact that Pharming doesn't have an internal audit department made your job more difficult or maybe asking the same question in a different way. Would you recommend Pharming to really start implementing an internal audit department.

Well, as you know, Pharming is also subject to the SOX rules and regulations. So in that process, Pharming is also currently pursuing on the internal control framework as Jeroen or others have been mentioning as well right now. So in that perspective, yes, going forward, when more controls have been implemented, you probably also have seen our auditors report on internal control in the process going forward on implementing more controls, it could become relevant to also have an internal auditor in place. Right now, there is not really a need for that considering the control environment.

Thank you. We'll now answer any questions that were asked online. And I note that no questions have been asked online. So we will now proceed with the voting on the financial statements. Our shareholders are proposed to adopt the financial statements of the financial year 2022. Once I have opened the voting on this agenda item, again, you were invited to press 4, if you wish to vote in favor of the proposal; or against. If you wish to vote against the proposal; or abstain, if you wish not to vote. And these votes will not be included when determining the voting results. I will now open the voting, so please cast your votes. [Voting]

We'll now close the voting. The voting results, including the votes received by means of proxy will be shown on the screen in just a few seconds. I'm pleased to confirm that the proposal has been adopted by our shareholders with a 99.66% majority. So the financial statements of the financial year 2022 have been adopted. On behalf of the entire Board of Directors, I'd like to thank our management and all the employees of Pharming for their dedication and congratulate them on the results achieved on the year 2022. The next topic on the agenda is Item 2F, the proposal to discharge the members of the Board of Directors. Scope of this discharge extends to the exercise of the duties during the financial year 2022. And so far, this is reflected in the annual report, in the financial statements and other public disclosures or in statements made during the general meeting. I'd like to invite our shareholders to ask any questions on this agenda item. Please go to one of the microphones if you have any questions. Okay. And we'll ask if there are any questions online. And I note that no questions have been asked online. So we will now proceed with the voting on this agenda item. Our shareholders are proposed to discharge the members of the Board of Directors and therefore, to release them from liability for the exercise of their duties throughout the financial year 2022. I will now open the voting and invite our shareholders in this meeting room to cast their votes. [Voting]

I'll now close the voting. The voting results, including the votes received by means of proxy will be shown on the screen in a few seconds. And I am pleased to confirm that the proposal to discharge the members of the Board of Directors has been adopted by our shareholders with a 99.04% majority. We will now proceed to agenda item 3, the proposal to reappoint myself and Deborah Jorn, our Vice Chair. I'll now hand over to Jabine van der Meijs, our Chair of the Corporate Governance Committee, to introduce this item and also to leave the voting on both proposals.

Thank you, Paul, and good afternoon to all our shareholders. As explained in the explanatory note, the terms of our Chairman, Paul Sekhri; and our Vice Chair, Deborah Jorn, in the capacity of nonexecutive directors are scheduled to expire at the closing of today's general meeting. The Board of Directors appoints the Chair and the Vice Chair from its Non-Executive Directors. So the expiration of their term as nonexecutive directors also impacts their mandate as Chair or Vice Chair. The agenda for today's General Meeting includes proposals for the reappointment of Paul and Deb, each time by way of binding nominations to facilitate their reappointment as Chair and Vice Chair, respectively. I will briefly summarize. The highlights of these proposals in accordance with the outline in the explanatory notes, starting with the proposed reappointment of Paul Sekhri. Paul was first appointed on 30th of April 2015. In consideration of the restrictions imposed by the Dutch Corporate Governance Code on the maximum term of office for nonexecutive directors, Paul is not available for reappointment for a full term of 4 years. We are pleased that Paul has confirmed to be available to stay on, depending on the search for a new chair that I just referred to. The Board is well aware and as duly considered, the comments from investors and proxy advisers with regard to the number of other directorships held by Paul. Therefore, I would like to reemphasize the special reason for nominating Paul today for a temporary appointment. The Board of Directors intended to appoint Steven Baert as a new Chair. However, as a result of his appointment as Chief People Officer and Member of the Executive Committee of GE Vernova. As per 1st of April 2023, Steven is regretfully not available for appointment as Chair of the Board. None of the other nonexecutive Board members were available either. And therefore, the Board had to initiate a search for a new nonexecutive director to be appointed as a Chair of the Board. The Board is of the opinion that it is in the best interest of the company and stakeholders to follow a prudent process to find the best candidate to succeed Paul Sekhri. In our view, quality should prevail over speed. This will ensure continuity and will also facilitate a smooth handover process when a new Chair will have been selected. Therefore, we propose to our shareholders today to reappoint Paul Sekhri as Non-Executive Director for a period of one year, expiring at the closure of the Annual General Meeting to be held in 2024. Paul Sekhri will resign from the Board as per the moment that a new chair has been appointed should that be earlier than the AGM of 2024. I can assure you that the Board is searching for candidates for the position of Chair who have sufficient time available in order to be an effective representative of our shareholders' interest with due observation of prevailing regulations, best practices and view of investors and proxy advisers. An Extraordinary General Meeting of Shareholders will be convened for the appointment of the new Chair to the Board if the search process has been completed well ahead of the Annual General Meeting of Shareholders in 2024. We are pleased that Deborah Jorn has also indicated to be available for reappointment. For personal reasons, Deborah wishes to limit her new term to 2 years. Therefore, we propose to our shareholders today to reappoint Deborah Jorn as a Nonexecutive Director for a period of 2 years expiring at the closing of the Annual General Meeting to be held in 2025. We will commence the search to ensure that the successor of Deborah will be available upon the expiration of our new term. The Works Council submitted a positive point of view with regard to the proposed reappointment of both Paul and Deborah. Documents summarizing the Works Council's point of view are part of the meeting documents for today's meeting. I'm now inviting our shareholders in this room to go to one of the microphones to ask any questions they may have.

Yes. My name is Keyner on behalf of VEB. You may be surprised, but I want to thank, especially Mr. Sekhri for being available. The special situation, which was not foreseeable. So thank you for that. However, it is very difficult for an outsider to step into a company and be the Chair from day one. So I was wondering whether it is indeed wise to immediately leave as soon as the new candidate has been proposed to the shareholders and has been appointed. Or maybe if it is wiser that the new person starts as a normal nonexecutive. And after half year, he or she really take over as Chair since it will take some time to get a better feel about the dynamics within an organization.

Thank you very much for your question. It's a very good question. How we see it is that we're taking this appointment very seriously. We have engaged an external search company who's doing so far an outstanding job. We're forecasting well in the whole search. And we're very comfortable with the candidates we're seeing. And in that process, upon appointment, we will make sure that handover is done effectively and successfully and completely. And that means that up to the point that we're comfortable, Paul will be remain available within this year. So we'll make that decision based on the candidate that we find and the comforts that we, as a team, get in being able to hand over the Chair role from Paul to a new board member.

We will now answer any questions that may have been asked online. And Paul, you would be the one. If there are no further questions online, we will now move on to the voting on the proposals presented under this agenda item. Each time by binding nomination as explained in explanatory notes to the agenda for today's meeting. In accordance with Pharming's Articles of Association, the binding nominations may each be rejected with a simple majority of the votes cast if these votes represent at least 1/3 of the issued capital. If any nomination is rejected by a simple majority of the votes cast, but such majority does not represent at least 1/3 of the issued capital, a new meeting could be convened. During the new meeting, the nomination may be rejected with a simple majority of votes cast. In that event, the Board will draw up a new nomination. I'm now opening the voting on the proposal to reappoint Paul Sekhri on way of binding nomination for the period for 1 year. [Voting]

Let's close the voting.

The voting results, including the votes received by means of proxy are now shown on the screen. And I'm pleased to confirm that the proposal has been adopted by our shareholders with a 63.88% majority. Congratulations, Paul, and thank you. On behalf of the Board, I would like to thank you for your availability to stay on pending the search of a new chair, as we discussed just now, also with support from the room. I'm now opening the voting on the proposal to reappoint Deborah Jorn by way of binding nomination for a period of 2 years. [Voting]

Let's close the voting.

I'm please to confirm that the proposal has been adopted by our shareholders with the 98.96% majority. Congratulations, Deb and thank you to you, too, for staying for 2 more years.

Great. Thank you, Jabine. And to the next agenda Item 4, we present the proposal to our shareholders to approve the payment of annual fees for the Chair and members of our new transaction committee. Steven, could you please introduce this agenda item as Chairman of the Remuneration Committee.

With pleasure, Paul. So as set out in the explanatory notes to the agenda, the Board of Directors decided to establish a transactions committee in January '23. The transactions committee supports the Board on any mergers, acquisitions, licensing or business development transactions. However, the remuneration policy of the Board of Directors as adopted by all of the shareholders in December 2020 did not yet provide for the payment of fees for the Chair and members of this new committee as it obviously did not exist at the time. So therefore, the Board of Directors proposes by way of a supplement to the remuneration policy to approve the payment of the following annual fees in cash to the chairs and the members of the transaction committee with retrospective effect as of January 2023. And for the Chair of the committee, EUR 6,000 gross annually; for each member of the committee, EUR 3,000 gross annually. These fees are the same and have been aligned with the fees payable to the Chair and members of the Corporate Governance Committee and the Remuneration Committee, respectively. So we stay in line there. That's all I have to say about this, Paul.

Great. Thanks, Steven. I'd now like to invite any shareholders in the room to go to one of the microphones to ask your questions. And if not, we will answer any questions that were asked online. And I note that no questions were asked online. So thanks, Steven. So we'll now move on to the voting of the proposals presented under this agenda item as explained in the Explanatory Notes to the Agenda for today's meeting. I'm now opening the voting. [Voting]

I will now close the voting. The voting results, including the votes received by means of proxy will be shown on the screen in just a few seconds. And I'm pleased to confirm that the proposal has been adopted by our shareholders with a 98.62% majority. Under the next agenda item 5, we will address the proposal to reappoint Deloitte Accountants as the company's external auditor for the financial years '23 and '24. Leonard, could you please introduce this agenda item as Chairman of the Audit Committee.

Certainly, Paul. Deloitte Accountants was first appointed as our external auditor during the general meeting in 2019. They were then reappointed for 1 year on 20 May 2020, and then again for another 2 years, the next year on the 21st of May in 2021. In March of this year, the Board of Directors supported by the Audit Committee evaluated the performance by Deloitte with duties in the past year and has reached a positive conclusion on their reappointment. Therefore, we propose to our shareholders to reappoint Deloitte as the company's external auditor for the financial year of 2023 and 2024. This proposal extends to the examination of Pharming's annual report and financial statements, the report to the Audit Committee and the Board of Directors and to issue an auditor's statement opinion on each financial year. Proposal to reappoint Deloitte for 2 years ensures continuity and basically builds upon the knowledge and the experience that they've got it in the firm. Thank you very much.

Thanks, Leonard. I'd now like to invite our shareholders in the room to go to one of the microphones to ask any questions. Is there are no questions in the room? Have any questions been received online? It looks like no. So thanks again, Leonard. We'll now move on to the voting on the proposal presented under this agenda item as explained in the explanatory notes of the agenda for today's meeting. I'm now opening the voting. [Voting]

We will now close the voting. The voting results, including the votes received by means of proxy will be shown on the screen in a few seconds. I'm pleased to confirm that the proposal has been adopted by our shareholders with a 99.66% majority. Congratulations to Deloitte. We will now proceed with the proposal under agenda Item 6 to amend the Articles of Association. The proposed amendment will result in an increase in the authorized capital by 20% to EUR 10,560,000. This represents 1,056,000,000 shares with a nominal value of EUR 0.01 each. The authorized capital sets the maximum number of shares that can be issued by the company. The proposed increase will facilitate the issuance of new shares to support the further growth of our company and avoid the need to amend the articles of association at regular intervals. I would like to emphasize that the actual issuance of new shares by the Board of Directors remains conditional upon the authorization granted by the General Meeting of Shareholders. The renewal of the existing authorization is on the agenda of today's meeting under agenda Item 7. Any issuance of shares in excess of such authorization will each time require a decision to that effect by our shareholders. It is also proposed to authorize each civil law notary candidate, civil law notary and lawyer working with NautaDutilh to execute the deed of amendment to implement the aforementioned amendment. I'd like to invite any shareholders to go to one of the microphones to ask any questions. And we'll now also ask if there were any questions asked online. They were not, so we will move on to the voting of the proposal presented under this agenda item as explained in the explanatory notes through the agenda for today's meeting. I'm now opening the voting. [Voting]

I will now close the voting. The voting results, including the votes received by means of proxy will be shown on the screen in a few seconds. I'm pleased to confirm that the proposal has been adopted by our shareholders with a 96.62% majority. The next item on the agenda is Item 7, the proposed authorization of the Board of Directors to issue new shares or rights to acquire shares. As mentioned during my introductory remarks, the Board decided to withdraw agenda Item 7 sub-B. So the only proposal under agenda Item 7 sub-A will be up for a vote today. This proposal covers the designation of the Board of Directors for a period of 18 months starting today as the body authorized to issue new shares or the rights to acquire shares. The authorization is limited to 10% of the issued share capital as intended for generic corporate purposes. This authorization may be used, for example, for Pharming's general financing purposes. This includes up to 3% of the issued capital share issuances under the remuneration policy for our Board members and the incentive arrangements in place for the CEO. The issuance of stock options or restricted shares under the equity incentive plans for our staff are also covered by this authorization. The Board will be also authorized to limit or exclude the preemptive rights of existing shareholders when issuing shares or rights to acquire shares. Once approved by our shareholders, the authorization will replace the existing authorization for general purposes that was granted on the 18th of May 2022. I'm now inviting our shareholders in this room to go to one of the microphones to ask any questions.

Keyner on behalf of VEB, just to be 100% clear. I think I know the answer, but this still means that you can use about 7% of the shares to make any kind of acquisition or in-licensing agreement or whatsoever.

I'll now answer any questions that were asked online. And having seen no questions online. We will now move on the voting proposal presented under agenda Item 7 sub-A. This proposal entails the authorization of the Board of Directors to issue shares up to 10% of the issued capital for generic purposes, such as financing. I'm now opening the voting and invite our shareholders in this meeting room to cast their votes on this proposal that is described in more detail in the Explanatory Notes to the agenda. [Voting]

I will now close the voting. The voting results, including the votes received by means of proxy will be shown on the screen in a few seconds. I'm pleased to confirm that the proposal has been adopted by our shareholders with a 97.24% majority. The next item on the agenda is agenda Item 8. This item relates to the proposed designation of the Board of Directors for a period of 18 months starting as of today as the corporate body authorized to repurchase fully paid up shares in Pharming's own capital up to 10% of the issued capital. I kindly refer you to details of the Explanatory Notes of the agenda for today's meeting. The proposed designation will replace the current authorization as granted by the general meeting on the 18th of May 2022. Are there any questions? Are there any questions online? There are no questions online, so we'll move on to the final voting round for today's general meeting. I'm opening the voting and invite our shareholders in this meeting room to cast their votes on the proposed authorization of the Board of Directors to repurchase not more than 10% of the issued capital. The proposal is described in more detail in the Explanatory Notes to the agenda for today's meeting. [Voting]

And I will now close the voting. The voting results, Including the votes received by means of proxy will be shown on the screen in a few seconds. I'm pleased to confirm that the proposal has been adopted by our shareholders with a 99.29% majority. Final item 9 is any other business. Under this agenda item, we will address the questions that are of a more generic nature Obviously, to the extent the topics are in the scope for this meeting, and please go to one of the microphones if you have any questions.

[Interpreted] My name is [indiscernible] I understand it correctly that in the presentation sheet, for your presentation, the additional platform program of [indiscernible] was left out?

And that is correct. Yes. We recently announced that we ceased that project. You have seen that in the results for the first quarter, the presentation of last month.

[Interpreted] Good afternoon. My name is [indiscernible] A few years ago, you invested -- or you took over the business of Sobi rather in order to better serve Europe. So what happened there? I've not heard anything about that anymore.

The repurchase of the commercialization rights for Europe from Sobi was done, indeed, to actually get to full revenues, of course. And you see that we have -- we are generating sales in Europe, and we are now getting the full revenues of that. So in fact, whereas before, it was not -- we were actually handing in money for the business. We were -- since we took back the rights, we are making a small profit in Europe. That's the first thing. Secondly, of course, we already had leniolisib in licensed from Novartis. And of course, we knew that this business was very sort of promising for a European area as well. And it was deemed to be a strategic move to also have our own people on the ground already and build relationships in those European markets. It has been taking place and is taking place. We are further extending our commercial footprint as well and preparing for the launch of Joenja in Europe, of course, following the subject to, of course, the positive opinion and approval in the European Union. So therefore, this was the reason, and we're executing on it, and we actually expect, as you heard in the earlier presentation today, the European business will become a very substantial part of our business going forward. Thanks to the fact that we have been making those relationships over the years because that takes a long time to get relationships in the market.

Are there any online questions -- sorry, we have a question here.

[Interpreted] Yes. So I understand that this is the last item. Any other business? Or will we get any other business in a minute. No this is any other business. I was afraid of that. So I'll have to do this now. So I have a lot of paper, but I'm limited to 3 questions. My name is [indiscernible]. 3 questions. That was it. I didn't get that because it was said in English, right? Here's the thing. APDS as a disease does have gradations levels or not like [indiscernible] you have those stages or gradations as well? You need to have an injection a couple of times per week, sometimes per month, sometimes per year?

Can I please answer the question in English? There is, of course, different manifestations, clinical manifestations of such a disease that is correct. However, What you see in contrast to hereditary angioedema where you have attacks and those attacks go away once it treated and patients can have a normal life in between the attacks. Of course, always threatened by the attacks and the attacks are stress related. APDS is a different disease. APDS is a progressive disease that continues to go and get worse and worse and worse. So you have seen the presentation by Dr. Relan. You've seen the clinical manifestations that occur already very early in childhood and start progressing down that certain part eventually leading to in a very high percentage of malignancies of the lymph system, and of course, malignancies are associated with a very bad lymphomas -- are associated with a very bad outcome. And therefore, it is a very different disease. So yes, the clinical manifestations can be at any point in time, different between patients, but eventually, they all go down the spiral and go from bad to worse. I hope that answers your question.

[Interpreted] Yes. But still, everybody who is suffering from this disease is eligible or qualifies for drugs like Joenja. And I think admission was 46 weeks before you could have access to the medicine. They found 200 patients in [indiscernible]. So here's my logic. You have 500 patients suffering from the disease at the end of the year. So 300, 400 patients, 500 in total. And that is if we have an admission for 46 weeks, right? There's a high need.

[indiscernible] Reports because, as you well know, we do not give any guidance. We have said that before. And of course, I would like to make the point though that getting these patients into the therapy will require a lot of practicalities here. You have read that in various articles and newspapers as well. But indeed, we are working very hard to get those patients as soon as possible on therapy because the therapy is now available for those patients. And make a belief that we will not wait and those -- most of those doctors also would not like to wait. However, it will take time for those patients to come into therapy.

[Interpreted] So I'm still working through my questions. So below the age of 12, you estimate you have 25% of the population, right, [ APDS ] population. So statistically speaking, that's up to 50 years. And then it's 25% [indiscernible]. So there are a few people over the age of 50 who have APDS.

10 to 12 years ago. So we do not have full insights in that. But we are -- and the estimation is that about 20 -- you're correct, about 25% of the patients that we have so far identified are below the age of 12. So are not yet eligible for access to therapy until such time that we have the periodic approval. And the first, as you heard already presented, the first trial from 4- to 11-year olds will cover the majority we expect of those children. So once that trial is there, the majority of those 25% of patients will be available -- will be reachable for therapy until such time they are not. And as I said, we have no further insights because it's such a new disease and how many people are older than that. But the majority of patients, and that's also important to note here in the clinical trial, the vast majority of patients that were included in the trial were between the age bracket of 12 and 24 years old. So it's a fairly young population that's already severely affected by this disease.

[Interpreted] So that's going on. So it's only increased? So when you're 60, 70 years old, you're suffering from this disease. It won't burden you as much but it is a progressive disease. And that was still my first question, right? I have lots more. My most important question is this. In view of the indication of leniolisib, at the beginning of the presentation, you talked about the future of Pharming, et cetera, and that was 2 years ago. My neighbor said as well. RUCONEST, of course, was the promising drug. And it was like a miracle cure, right? The silver bullet. But now it's only leniolisib with everything attached to it in the second half of this year. So a lot will be published. I understand can wait, August, September, when we hear more about this?

On the feedback of the regulatory authorities, and that's always difficult to gauge, but it's certainly going to happen in the second half of this year. That has been assured by our Medical -- Chief Medical Officer. And I can't speculate yet which month that will be, but you will be notified by means of a press release.

[Interpreted] Well, I thought you showed more before. So you're physician, right? And you're an immunologist. Well, there was something about immunology. So bacteriophages, right? I talked about this more often here. Let me press home to you, bring home to you. You quoted this in the past. It is not that easy to get into this world. I have no idea why but very difficult world to access. But we read more about the hospital bacteria, the flesh-eating bacteria. Penicillin. Apparently, the bacteria don't respond to it anymore. So we need to talk more about the bacteriophages, especially in the short run. And before you take over the position of [indiscernible], right, if I understood it correctly.

We have, indeed, in the past, investigated that and came to the conclusion that it was not viable to unfortunately invest in that opportunity. So of course, we are scanning the horizon as we already illustrated for in-licensing opportunities that have clinical proof of concept. In other words, solid clinical trials have to be already performed before we engage in this. Otherwise, this is not consistent with our risk profile.

[Interpreted] bacteriophages are proven. The East of Europe are participating in this. And we are a Western country -- the Western world, we're totally dependent on something that comes from the East.

That has to be it for your last question. I'm sorry, there's another question.

I am going to pose my first question, a rather morbid question. You had the patient with APDS. If they get treatment, they will stay in treatment for the rest of their lives. So it's a growing market. Each patient we have is one patient for the rest of the life and each patient discovered is a new patient.

That's correct. Joenja is actually changing the -- it's a disease-modifying therapy as we call it. That means that you heard explanation of how it actually works. Joenja brings back the PI3 kinase delta enzyme to normal levels like people that are not affected with APDS. So the immune system can start functioning again, and you see it in all the parameters. Indeed, if you stop it, and we have data also for that virtually almost immediately parameters go in the wrong direction. And if you start Joenja, the parameters go back to the healthy balanced immune system. So yes, you are correct. Joenja is a disease-modifying therapy and will have to be taken for the rest of your life.

[Interpreted] Can you say a bit more about the enthusiasm of physicians and patients who are taking Joenja. Are they happy with it?

As part of the dossier, the regulatory dossier, the Joenja was used by -- Joenja was offered to continue to use by the patients that were participating in the 12-week study. Virtually all those patients actually committed to that and continue to use Joenja for a long time. So at a point in time, when we actually submitted the regulatory file to the FDA and EMA, an average of more than 2 years. These patients have been using the product and up to 7 years in individual cases. All patients continued. And you heard Dr. Relan explain that the good news is not only that Joenja was approved on the basis of a double-blind placebo-controlled trial, but also that the side effect profile during the 12 weeks was equal to placebo. That's the first thing. And secondly, and that's also very important. This is what actually presented at the American Hematology Conference, Hematology Conference in December. The long-term follow-up of all those patients that were using showed that the tolerability and the side effect profile remained consistently over those years. In other words, you have a drug now that actually has -- is efficacious, that has proven to be efficacious in the short-term trial with side effect profile equal to placebo and also the side effect profile and tolerability stays like that during the long-term follow-up. That means important thing for chronic medicine, of course, that you have a very favorable risk-benefit ratio for this compound. And that means also that it's a clear sign of all your patients in those long-term follow-ups continue to use the product. And that was data until the end of '21. And the European authorities have asked us to submit more data follow-up. And we have, of course, more data because that study still continues. And I'm glad to tell you that the results remain consistent, and that is, of course, now has been submitted to the European authorities for the further review. So yes, that is correct. Everybody is -- by that means very enthusiastic about the compound and continues to use it.

I missed the words enthusiastic. The rest was scientific and things like that.

Okay. Thank you very much. There were no questions online. But just prior to formally closing our meeting, and I realize I'm the person standing between you and drinks in the foyer. I just simply want to personally thank a few people. This will be the last time that I'll chair an AGM and would, therefore, like to thank, first of all, Sijmen, who I've known for 25 years and his entire leadership team for their passion, their dedication and commitment to patients. the company and to our investors and shareholders, our devoted Board of Directors with whom it's been an honor and a privilege to work with these past 8 years. And finally, to all of you, our shareholders, for your unwavering support of this company and this mission and vision. Thank you so much. And with that, we look forward to having a drink with you outside in the foyer. Thanks. [Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.]