Pharming Group N.V. (PHARM) Earnings Call Transcript & Summary
May 21, 2024
Earnings Call Speaker Segments
Richard Peters
executiveGood afternoon. Ladies and gentlemen, I'm Richard Peters, the Chairman of the Board of Directors. I would like to welcome you 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. I'm sitting here to get together today with the following nonexecutive directors: Deb Jorn, our Vice Chair; Barbara Yanni; Mark Pykett; Jabine van der Meijs; Leon Kruimer; our CEO and Executive Director, Sijmen de Vries; our CFO, Jeroen Wakkerman. Our other Nonexecutive Director, Steven Baert, is joining us online today. The members of our Executive Committee are also present today, either in this meeting room or online. I'm also pleased to welcome the Chair of our Dutch Works Council, Ms. Zhen Liu. In addition, also with us today in this meeting room are Ms. Louise Zwama, partner at our external auditor, Deloitte; and Mr. Paul van der Bijl, Civil Law notary and Partner at NautaDutilh. As we are a global company, this meeting will be held in English. However, for the convenience of our Dutch shareholders, please feel free to ask your questions during the Q&A sessions in Dutch, and we will translate them into English when necessary. Please note that the use of mobile phones and recording services is prohibited. I kindly ask you to switch off your devices now if you have not done so already. This general meeting was convened in accordance with the applicable statutory requirements. The notice to convene was published on the April 4, 2024 by way of an announcement on Pharming's website and a press release. The agenda and all meeting documents were published at the 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. 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 arrived at the first voting item on the agenda. At that moment, I will also inform you about the number of shareholders and shares that are represented during this meeting. These numbers are being verified at this moment. You are all invited in the notice to convene to send us your questions on the various agenda items by e-mail. We have not received any questions in advance. 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 on like -- online. Unique login details have been submitted for that purpose. All shareholders who are attending this meeting in this room will, of course, also be able to ask questions today on the respective items on the agenda. For an orderly conduct of the meeting, we will first answer under each agenda item the questions being asked in this 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-answer part of any agenda item. Please raise your hand if you are not able to walk to these microphones, we will then come to you with a microphone in hand. For the minutes, I kindly ask you to state your name and if applicable, the name of the shareholder that you represent before asking your first question. Finally, please limit your number of questions to three to make sure that all shareholders would be able to ask their questions. You are, of course, welcome to wait again in line 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. The final minutes will be adopted within 3 months thereafter, so by the 21st of November 2024 at the latest. Ladies and gentlemen, I now would like to move on to the second agenda item, the annual report for the financial year 2023. This agenda item includes several subitems. I invite our CEO, Sijmen de Vries, together with our CFO, Jeroen Wakkerman, to elaborate on the business, the operations and results for the year ending December 31, 2023. Our Chief Medical Officer, Anurag Relan, will also share some highlights of the launch process for Joenja and an update on current plans and activities, including plans to expand development into new indications. Sijmen?
Sijmen de Vries
executiveThank you, Chairman. Ladies and gentlemen, I'm very happy to take you through the annual report of 2023 and the results in the business today. I would like to have the forward-looking statement slide, please, if it is possible, yes, thank you very much because we will be making forward-looking statements today. And those are for future expectations, of course, that are based on our current plans and expectations. And I would like to remind you that the actual results could vary much different from those. So having said that, I would like to move to the next slide. And that tells you that we are building a global rare disease biopharma company. And we are in the good position to be able to do that because of RUCONEST, to start with. RUCONEST, of course, as you know, product from our own research, from our own platform, that came to the market already in 2014 -- late 2014, it was approved in the U.S. It was already earlier approved in Europe. And as you all know, the business is mainly 97%, 98% U.S. business where we talk about here. And as you can see and already have read, of course, we had a stellar year in 2023. Even after so many years in the market, RUCONEST still continues to grow very significantly, up to $227 million of revenue. And we still see till today, and you saw the results again in the first quarter results, that RUCONEST continues to grow. It continues to grow both in terms of patients that are using RUCONEST and in prescribers that are prescribing RUCONEST. And it tells you something that in a market where many, many alternatives now are available, RUCONEST has a special place, a special segment. And I will elaborate a little bit on that later in the presentation. RUCONEST enables us to actually grow the company further forward. And we took the -- now in hindsight, a very good decision, of course, back in the days in 2019; to in-license leniolisib from Novartis. And we're very proud, of course, that we could be -- we're able to launch leniolisib last year on the brand name Joenja in the United States into the U.S. market. And you probably saw that within weeks from having the product approved by the FDA, the product was not only in the hands of patients, but was also reimbursed. And this is a testament to how effective the U.S. organization is when it means to bring the product to the market and also get it commercialized and reimbursed. And you saw the revenues in 2023, $18.2 million, another almost $10 million added in 2024. That brings the first full year in the market for Joenja up to $28 million of revenues, and that in a very new disease, the disease that was only developed -- that was only discovered 10 years ago and where there is now already a disease-modifying drug on the market. That is, in itself, quite a novel event that something happens that quick. That means, however, that because we're dealing with an ultrarare disease that patient finding is a very important part of the equation of making Joenja a commercial success. And we will talk about that more. I will elaborate a little bit on that. And my colleague, Anurag Relan, will tell you more about that. In addition to that, recently, we got the approval in Israel for Joenja. And we have, of course, regulatory activities ongoing in Europe, United Kingdom, Canada and Australia. And in addition to that, the label is for children of 12 years and older. We have a couple of pediatric studies ongoing that will bring the pediatric label eventually and a clinical trial in Japan that will enable us in the not-too-distant future, and Anurag will elaborate on that as well, to actually bring the regulatory trial to Japanese authorities. Joenja, of course, is very important for the growth of the company and represents a near-term opportunity. In that respect, we're even more excited about the fact that as the next stage in further developing our pipeline, we found the possibility to actually formulate the second indication for leniolisib, PIDs with immune disregulation beyond APDS, and we are preparing a Phase II dose-finding trial. And that is, of course, a significantly bigger indication than APDS. So leniolisib has all the signs of becoming a pipeline in a product. Furthermore, to accelerate our growth further, we have a strong focus at this point in time on business development. We hired our new colleague, Alexander Breidenbach, last year as Chief Business Officer. And he and his team are making very good progress on looking for additional in-licensing opportunities or acquisition opportunities that have a clinical proof of concept or later in development to actually start -- or continue to accelerate the growth of the top line growth as a company. You also saw in this slide that we recently decided to terminate the early stage -- the very early stage development of OTL-105 because we want to focus initially on the late-stage opportunities that we have in our hands with Joenja. And that, we believe we can in-license or acquire. For 2024, because of the strong -- continued strong performance of RUCONEST, hence the continued growth of Joenja, we, therefore, for the first time in our history, gave revenue guidance of between $280 million and $295 million, which represents a growth of between 14% and 20%. So we are well on our way with building that rare disease company. And this is, of course, a depiction of the pipeline where you see RUCONEST in the market, Joenja in the market in the United States, where you see leniolisib undergoing regulatory reviews in the European Union, U.K., Canada, Australia and as said, Israel, that is now approved, of course, this slide should be updated. And you see the pediatric trials ongoing for leniolisib in Japan in the pediatrics. And then on the bottom, you see the Phase II about the start for the PIDs with immune dysregulation. So before I go into the pipeline, I would like to talk to you about another topic that is of importance, and that is the ESG program that we are engaged in. So we have taken very significant steps in 2023 to embed environmental, social and governance or in short, ESG, on our strategy, planning process and systems in order to build and maintain a sustainable business. As the field is very broad, our ESG journey is centered around the European Corporate Sustainability Reporting Directive, or CSRD. CSRD will be applicable for Pharming as of the financial year 2025, and we are on track to ensure compliance with reporting requirements in accordance with the European Sustainability Reporting Standards. However, as a dual-listed company, we will also have to ensure compliance with the SEC climate disclosure requirements that are also expected to become applicable to Pharming as of the financial year 2025. So amongst others, we performed in 2023, a double -- so-called double materiality assessment according to the CSRD requirements. We also performed a technical gap analysis and an organizational readiness analysis. The double materiality assessment assists us to assess both Pharming's most significant impacts on people and the environment and the most significant sustainability-related risks and opportunities affecting Pharming. On the screen behind me, you can now see the 10 material ESG themes that the Board of Directors endorsed for Pharming based on the outcome of that assessment. These themes are deemed to be the environmental, social and governance matters that are most relevant for Pharming, in view of our core activities as a pharmaceutical company. We are, at this moment, in the process of defining our specific ambition levels within these themes, including the targets and metrics for each of these material themes. We expect to be able to publish these targets and metrics later this year following their adoption by the Board. Assessing our compliance with European taxonomy requirements is another important priority for this year. In our annual report on the year 2023, you'll find a separate section on the ESG. I invite you to read that section, if not done already, for a detailed outline of our existing and planned activities and other initiatives linked to each of the components of ESG. In that section, you will also find more details on the double materiality assessment, any outcome of our earlier stakeholder analysis. Now I would like to continue to talk about the pipeline. And of course, here, I was already alluding to RUCONEST, the cornerstone of our development -- of the development of our company. It remains the only recombinant treatment that targets the root cause of hereditary angioedema by replacing that missing C1-INH esterase inhibitor. And is already -- as I said already, for a long time in the market, it was approved in the United States late 2014, and it's well tolerated, effective and is of course, indicated for acute treatments, which means that patients that are treating their hereditary angioedema attacks with acute medication only can use it, but also those patients that are under prophylactic treatment and who always -- almost always suffer from -- continue to suffer from breakthrough attacks. So even with better pump -- even with far better prophylactic treatments now, breakthrough attacks occur in sometimes up to 80% of those patients and in the best cases, up to 50% of patients from breakthrough attacks. It is therefore mandatory for all of the U.S. patients that are using prophylaxis to always have [ rescue ] therapy at hand. And that is where RUCONEST continues to fulfill its unique position. And you can see the efficacy numbers that are there. And you can see that there is no, speaking of, breakthrough attacks or rescue medication, which you see so often in other clinical trials about hereditary angioedema. And that explains to you why there's continued strong in-market demand in the U.S. And you see us reporting new enrollments of patients that were up significantly in '23. That, again, continue to go on in the first quarter and are predictors of course, for the stable basis of growth that RUCONEST still is for the company. You see the U.S. revenue indicators, the leading U.S. revenue indicators, active patients, vials shipped, physicians prescribed, it's all going up in the right direction. So RUCONEST continues to be the backbone of our company, and we expect it to be that for a significant period of time. And it is important also in the light of future developments because there is, of course, continuing new competition come to the market. And most notably, there is now an oral acute medication that is currently undergoing a regular -- or will be starting soon a regulatory review, we expect. And that could well come to the market. And it is important to realize that the patient population that actually uses RUCONEST has failed on all other medications. That means the products that are in the market that are not C1 inhibitors, and RUCONEST, remember, is the only C1 inhibitor; have all -- these patients have all failed before they moved on to RUCONEST. And that's a big contrast to -- for instance, if you look at clinical trials with these kind of new compounds that use exclusion criteria for the clinical trial, for patients that have failed on previous kallikrein/bradykinin inhibitors, the other mode of action. So it's an interesting observation that we make here on our side that we're serving a very special population in the market that cannot come by on any of the other compounds. And therefore, we believe that the segment that RUCONEST represents, i.e., the very sick patients that have a high frequency of attacks; is a segment that is unique for RUCONEST and can serve -- and where RUCONEST can serve the need for patients, where those patients will very much likely fail. It is not to say that if these kind of companies -- these kind of products would come to the market that they wouldn't try it. But we're very confident that we can continue to serve this patient population with a high unmet and -- continued high unmet medical need with RUCONEST to manage their hereditary angioedema. So far for RUCONEST, so let's look at the first time of the market in -- with Joenja. Strong commercial execution, I already said it. It was 28 million of sales the first 12 months, and we continue to enroll and add patients. It's a new disease, there's no competition. It means you have to find patients. And we have already got 83 patients reported on active therapy by the end of Q1 '24, with 5 additional enrollments pending authorization. It means also that we have more than 50 patients that are diagnosed, of 12 years and older, in the U.S. that are not yet enrolled and 50 -- more than 50 patients that are pediatrics that have not yet -- because they're younger than 12, but cannot yet get the benefit of Joenja, but have to wait for a periodic approval. Now I was already alluding to the revenues, and the revenues will continue to grow as we expect to get to enroll more patients. And there are more patients. And we're talking about -- when we talk about patients, we talk about genetically confirmed patients with a genetic test. We have more than 500 of those patients that we are expecting in the U.S. on the basis of literature. And we have already got more than 220 diagnosed, of which 15 were newly diagnosed during the first quarter, including some of the variants of uncertain significance resolution, and I'll talk a little bit more about that and Anurag will talk in detail about the VUS. So how do we find those new patients? Well, we find those new patients by continuing to offer the free genetic testing that we're currently offering to doctors who have patients that they are suspect -- that suffer from APDS. That's the first thing. Secondly, with the patients that we have identified, and it is a dominant autosomal mutation, it means that there will have to be family members that also have APDS. We will offer them now, on a personal basis, our genetic counsels. For instance, we'll go to them, and we'll offer them free genetic testing for the family. And I think that's important because there will be members that are in their family that have the disease that has yet gone not very well noticed or diagnosed, that's the first thing. And secondly, on the bottom of the slide, there's more than 1,100 of patients that have been undergoing genetic testing because they had the symptoms and signs for APDS, that got back a result that was a very -- so-called a variant of uncertain significance. That means that the mutation is in the relevant gene, but the specific mutation is not yet associated with the hyperactive pathway that APDS requires you to have. That means that you need to figure that out. That means it's a new disease that you have to clarify the full breadth of the disease, and that is the research that is currently ongoing. And that is when we expect next year in 2025 to have a full answer on the description of the disease [ IA ] to have a percentage of those patients and be able to diagnose definitively as APDS. And Anurag will talk a little bit more about that. So in other words, if you look at that slide over here, you see how the cascade builds up. We currently have the label for 12 years and older. We found 220 of the 500 patients. We have 83 on active treatments. We have more than 50 diagnosed, not yet enrolled, and we have the ongoing patient finding and family testing and VUS resolution efforts. Then, subsequently, we have the global expansion for leniolisib following the regulatory reviews. Then we have the pediatric studies, where once we get the label, another 25% of patients will immediately become eligible. Then we already have found more than 840 patients globally. And we have -- of those 840 patients, we have 138 patients over and above the [ U.S. ] patients that are already on therapy, either via access programs or clinical studies. And then, of course, as a big potential inflection point for the future to further accelerate the growth, we have the second indication, where a Phase II dose finding trial will soon start in this new indication, immune disregulation linked with PI3-kinase delta signaling similar to APDS. And that, as you can see on the bottom, has -- and it's not such a new disease, that's already well figured out, has prevalence of at least [ 5 per 1 million ], so at least more than 3x more than APDS. So you can see why we feel very strongly that Joenja or leniolisib represents a pipeline in a product. And that is a good moment here to ask my colleague Anurag Relan to go forward and to tell you a little bit more about Joenja and the market. Anurag, please.
Anurag Relan
executiveThank you, Sijmen. So let's continue the discussion about Joenja. Joenja was approved, as Sijmen said, in 2023, by FDA for patients who are 12 years and older with APDS. This approval was based on a randomized double-blind, placebo-controlled study, in which Joenja met both primary endpoints, with significant efficacy results. It demonstrated a significant improvement in other secondary parameters also, which I'll be reviewing with you. Importantly, there were no drug-related serious adverse events or study withdrawals in these studies. And on top of that, what we saw from the long-term use of Joenja from ongoing open-label studies was similar results to what we had seen in the randomized study. And in addition, what we saw was that patients were actually able to stop the use of immunoglobulin replacement therapy, and we also saw a reduction in infections over time. These results were consistent with what we've seen in the double-blind placebo-controlled study, and we continue to collect additional data on long-term use of Joenja in APDS patients. But having a therapy for patients is not enough in the world of rare disease. Unfortunately, these patients often go on a long journey to get a diagnosis. So we're doing several things to help these patients arrive at the correct diagnosis. The first part is trying to educate physicians to think of APDS in the right setting. So we're doing a lot of work here, and I'll be sharing with you some of the recent abstracts and publications that we have about APDS as well as Joenja on the use in these patients. But as Sijmen said, the diagnosis of APDS is made through genetic testing. And we have a sponsored no-cost genetic testing program now available in the United States and Canada for these patients so that there is limited barriers for them to obtain a genetic test. On top of that, we provide genetic counselors to help patients with the pretest as well as post-test counseling that can be needed in these -- interpreting these results. And then because APDS is an autosomal dominant disease that's inherited in families, we know that there are additional patients likely undiagnosed within a given family. So we've also made genetic testing available to family members of APDS patients to assist them in getting the correct diagnosis. But unfortunately, this isn't the end of the story. A patient can go on a long journey, get a genetic test finally done, but then end up with a result which is inconclusive. And this is what Sijmen referred to earlier as a VUS or variant of uncertain significance. So in this case, the result comes back as inconclusive because the variant or the specific mutation that these patients have been found with has not been previously seen. And we're doing several things here to help patients arrive at a correct diagnosis. The first is that we're making available functional testing so they can actually have their pathway activity measured to determine whether or not they have APDS. And then on top of that, we're actually doing a large scale experiment whereby we're testing every possible variant or generating cells that have every possible variant and then testing those cells to determine conclusively, whether or not a given variant can cause APDS. We already know this is a serious problem within the APDS and in general, the primary immune deficiency community because there are more than 1,100 patients that have a diagnosis of VUS, basically an unconfirmed diagnosis, and they are stuck. They're stuck in limbo because they don't know what to do with this. The doctor doesn't know what to do with this. So we believe that by offering further results here and offering further testing, we will be able to help these patients arrive at a correct diagnosis. And we expect that many of them will actually turn out to have APDS. We expect that these studies will be completed in the fourth quarter of this year and in early '25 be able to report back to you on some of those results. So let's talk a little bit about some of the data that we presented recently at some medical conferences. The first, it's important to recognize that we talked about it frequently that APDS is a serious condition. It's associated with a lot of morbidity and mortality. And so we did a study review to see what the costs are associated with APDS. And as you can imagine, there are significant costs with the care -- associated with the care of APDS patients. On top of that, we've done a review of the mortality in APDS. This hasn't been done before. People knew that it was a serious condition, but we went through the literature and found the actual mortality. And again, there is significant mortality associated with APDS. Most of that is actually due to the development of lymphoma. Frequently, these patients develop lymphoma and as a result, have many complications related to the treatment of lymphoma. But unfortunately, many of these patients also die from other complications related to APDS. And that's one of the other bits of information that we're putting out there in the medical literature, so that people know about APDS and know that this is a serious condition and demands treatment. And as I mentioned earlier, we also have long-term data use of leniolisib in these patients. And we've been publishing a good amount of this data showing how patients' infection rates decrease, showing how their use of immunoglobulin therapy can also decrease. And we've been able to show importantly that some of the long-term complications are able to be stopped with the use leniolisib, and we've been able to see that bronchiectasis, for example, this lung complication is -- it doesn't worsen when patients are started on leniolisib. And then lastly, we shared some data recently on the use of the sponsored testing program. This sponsored testing program has led many patients now to be able to have the correct diagnosis, whether it's APDS or some other condition. And this has been actually a very welcome program by the primary immune deficiency community. So that's a lot of the work that we're doing in terms of helping patients arrive at the correct diagnosis. Let's talk a little bit about other things that are going on with Joenja. In Europe, we are currently awaiting the CHMP opinion on our marketing application, and we expect to be on the agenda for an opinion later this month. So we're anxiously awaiting that. You heard Sijmen mention that we have now a marketing authorization in Israel, and that was just a couple of weeks ago that we received that. We've also completed enrollment in our Japanese clinical study, which paves the road for an eventual application in Japan. We have several reviews ongoing sale in the U.K., Canada and Australia, and these are all under review by the health authorities. And then there's 2 pediatric studies because we know that APDS begins really at birth, it's a genetic disease. And we have 2 studies going on, the first of which has already completed enrollment, and this is in children ages 4 to 11, and we have a study going on in children ages 1 to 6, which is continuing to enroll. And that first patient was treated just a few months ago, about 6 months ago. And then you heard Sijmen mentioned that we also have expanded access programs. These are programs whereby we make Joenja or leniolisib available to patients who don't otherwise have access through a clinical trial or through a commercial authorization. And then lastly, I'll be spending a little more time talking about this, but we're really excited about the possibility of using leniolisib in other primary immune deficiencies. And one of the things that we've learned in engaging with the immunology community is that there are other primary immune deficiencies that are similar to APDS. APDS really has 2 prominent features, one, is immune deficiency, which I think is clear to understand. And what that means is these patients get frequent infections. But APDS patients also have what's called immune dysregulation. And that means their body attacks themself. So that's a form of autoimmunity. And you also see this in terms of the manifestations of lymphoma or some of the other complications that APDS patients experience. What we've learned from talking to the immunology community is that there are other patients who have a similar clinical feature set, similar to APDS, who could also benefit potentially from leniolisib. And what we see on the next slide is some of those clinical features. So on the right side, you see all of these features, lymphoproliferation, autoimmunity, the gut disease, the lung disease, infections, lymphoma. All of these things, again, are very similar to what we see in APDS, and we know that in APDS that is driven through this pathway, what's called a PI3K pathway. And because of that pathway being overactive, we know that, that pathway drives these clinical manifestations. We also have another set of conditions and you see some of those mentioned there where there's also altered signaling. And because of that altered signaling, they also end up with the same clinical problems. So when we speak to doctors and specifically, we talk to doctors at the NIH who are involved in actually discovering APDS, they said, look, "we have another group of patients that we want to use and study leniolisib in." And they actually went on to -- if you see in the next slide, you can see what that study design looks like. And this is a Phase II proof-of-concept dose-finding study, a single-arm study in 12 patients where we're taking patients with other genetic diseases, but these are also other primary immune deficiencies with immune dysregulation. We're taking those patients and we will give them 3 doses of leniolisib over a period of several weeks. And again, the researchers involved in this are the same ones that we studied -- that studied leniolisib and APDS. And they're actually again, Dr. Uzel, for example, she is the one who discovered APDS 10 years ago. She is also the one who discovered one of the other conditions mentioned here, CTLA4. So we're talking really to the world's experts who came to us and said there's an unmet need in this other population similar to APDS, and we think that leniolisib is worth studying in this group. So as Sijmen mentioned, we're in the process of getting that study underway and hope to be able to report on the study start and the first patient treated soon. And if we think, on the last slide, what does this patient population look like? There's actually quite a number of these patients already described. And there are several large cohorts with each of these different mutations, each of these different primary immune deficiencies already described. And these cohorts, when we add them together and think about the size, it actually is about 5 per million when we think about number of patients that could benefit from treatment with leniolisib that have 1 of these 3 conditions. So we think the opportunity is significant here, much greater than it is with APDS, but the unmet need is also significant. And we have many patients and doctors, again, already wanting access for this. And so that's the reason that we're so excited about the opportunity to be able to start this clinical trial soon. So with that, I'm going to ask Jeroen to come up and continue.
Jeroen Wakkerman
executiveYes. Thank you, Anurag, and good afternoon. I'm very happy to take you through the financial highlights of 2023, starting off with the revenues. And revenues grew in 19 -- in 2023 by 19%, which was a result of higher RUCONEST sales volumes supported by a price increase below CPI in the U.S. market. And in the U.S., the revenue of RUCONEST grew from $200 million to $221 million in 2023. RUCONEST revenues in Europe and the rest of the world increased by 12% to [ $5.9 million ] in 2023. And the initial revenue of Joenja was $18.2 million following the launch of the product in April 2023. The gross profit increased by $32 million to -- or about 17%, which was in line with revenue growth. You see a box of other income with a few elements. Well, the other income reflects the sale of the priority review voucher to Novartis for a preagreed onetime payment of USD 21.3 million. And in 2022, the other income was largely determined by the reduction in the minority stake in our production partner, BioConnection. And at that time, we recognized a gain of USD 12.2 million. The operating expenses, or OpEx, increased by USD 64.5 million to USD 248.8 million, mainly in the category marketing and sales in support of the commercial launch of Joenja in the United States. $10.4 million of those costs are attributed to a milestone payment for Joenja following its first commercial sale in the second quarter of last year. An additional $25.7 million in expenses is related to the research and development expenses for leniolisib and marketing and sales expenses for Joenja. And our expansion efforts, driven by preparation for the launch and further commercialization of Joenja, led to an increase in payroll expenses of USD 24.2 million. And finally, on OpEx, we incurred impairment expenses related to our DSP production facilities amounting to USD 4.7 million. The operating profit decreased from USD 18.2 million to minus USD 5.4 million as a result of this increase in operating costs to build our Joenja business. The total net loss in 2023 amounted to $10.5 million compared to a total net profit of $13.7 million in 2022. And this decrease was again primarily caused by higher operating costs. And in addition, fluctuations in foreign exchange rates adversely impacted the foreign currency results in the statement of income. This slide shows the longer-term revenue development at Pharming with steady revenue growth until 2020, after which we saw the impact of COVID. And we're very pleased with the continued growth of RUCONEST from 2021. RUCONEST revenue grew by 10% in 2023 to $227.1 million, and we saw a record RUCONEST quarterly revenues in Q4 last year. And that's a record since the launch of the product in the U.S. over 9 years ago. Joenja is now driving enhanced growth with USD 18.2 million of revenue in 2023. And overall, we achieved 19% revenue growth in 2023. Then moving on to the development on cash flow and the cash position. The combined total of cash and marketable securities increased from $208.7 million at year-end 2022 to $215 million at year end 2023. The drivers of that were net cash flow from operating activities, and that was minus $17.3 million and was offset by incoming cash flow from investing activities, which was largely due to the sale of the priority review voucher that I mentioned earlier. Additional positive cash flow was generated due to favorable currency exchange rate fluctuations. Hence, we ended the year with a positive cash position of USD 215 million. For 2024, we've given the following guidance. Externally -- the revenue guidance for 2024 we have provided externally earlier this year is a revenue growth of 14% to 20%, i.e., we expect the revenue to land between USD 280 million and USD 295 million. We have also said that we expect RUCONEST revenue to show low to mid-single-digit growth. So for RUCONEST low to mid-single-digit growth. And that guidance is still valid today. Other key assumptions on the guidance is that we expect quarterly fluctuations and Joenja to be a significant driver of growth. And the key Joenja assumptions is that we continue to see growth in the patient on paid therapy, which we have witnessed in the Q1 of this year. And the U.S. pricing is at an annual cost, WAC of USD 566,000 per patient per annum. With that, I would like to hand over to Sijmen de Vries for the outlook for 2024. Thank you.
Sijmen de Vries
executiveThank you very much Jeroen. So yes, the last slide for this part of the presentation, the outlook for 2024. As you heard, we, for the first time, have given guidance on revenues, and Jeroen explained the details along those. You heard the important progress and the continued progress that we think about finding additional APDS patients, namely via the sponsored program, the family testing, the VUS validation efforts that will come and subsequently will convert those patients to pay therapy towards the end of the year, the outcome of that recombinant that's not -- that silico expert -- and [ silico ] experiment that will clarify the full breadth of the disease where Anurag was referring to, which means that we can expect a significant [ growth ] of patients in the subsequent year 2025 to add in United States and to the rest of the world. Also, you will see that ex U.S. increasing revenues are to be expected from the commercial availability through our Named Patient Program where patients in Southeast Asia are benefiting from, in the Middle East are benefiting from and also patients in the European Union and certain countries, there paid early access programs that are running. And other funded early access programs in those key global markets. The completion of the leniolisib clinical trials to support the filing in Japan, we were alluding to earlier and the pediatric trial that will start reporting very likely somewhere in the beginning of next year. The first pediatric trial that Anurag was referring to. Then of course, we expect regulatory actions in the European Union, United Kingdom, Canada and Australia. And then, of course, Anurag was referring to the fact that we will start very soon the Phase II clinical trial for the subsequent indication for leniolisib, which will -- could mean a very, very significant inflection point in the future. And last but not least, Alexander Breidenbach's team is very active in the search for in-licensing acquisition opportunities that at least clinical proof of concepts. So it means they have at least a clinical proof of concept in patients or are further in development stage towards commercialization to leverage and -- to leverage our commercialization infrastructure and to further accelerate the growth of the company. So you can see we're investing -- continue to invest very heavily this year not only because we are in launch mode with Joenja, but also we are expanding the indications for Joenja, and we continue to find those patients. But you can also see that the increase in revenue of Joenja that we expect. And you can see the level of operating expenses that the company is on a very healthy growth trajectory for the foreseeable future. Thank you.
Richard Peters
executiveThank you, Sijmen. Thank you, Jeroen. Thank you, Anurag. I would now like to invite our shareholders in this 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. Please do not ask more than 3 questions at the same time. Are there any questions? First question, please state your name and shareholding.
Unknown Attendee
attendeeGood afternoon. My name is [ Keyner ]. I speak on behalf of VEB [indiscernible]. I've got plenty of questions, 2 questions concerning the products, but I will ask that in a second round if you allow me to, Mr. Chairman. The first question I would like to raise the 2 elephants in the room. The first elephant, as we all know in here, is still very disappointing share price development. And we are happy at least to see that [ Mr. de Vries ] shares are concern and that he even is expressing his frustration very loudly in the last year. Now the relevant question would then be, if you're so dissatisfied about the share price performance is do the other potential shareholders are ignorant. For sure, it's all of us here because we did invest in Pharming. Is the rest of the world, are they crazy? Are you lacking in communicating your strategy and your results in a not-so-positive or constructive way, or are you communicated it very effectively, but the market doesn't believe you. So I was wondering what your assessment is of that situation, if there's anything you can change regarding that one. That will be the first question. Shall I continue or you want to?
Richard Peters
executiveWhy don't you want to give us the second question, and then I'll open up.
Unknown Attendee
attendeeThe second elephant in the room is, of course, the refinancing of the convertible, we all know that. I can imagine that something -- we have to do something which is -- which seems negatively on the short term, but which will make us all very happy in the much longer term share price while the interest rates have gone up. So obviously, if you're refinancing something, you pay more interest rate. Unfortunately, also the strike of the convertible has gone down. So it's much more likely that there will be more shares if this will be exercised in the end by the bondholders. The market reacted very negatively. So again, that's similar to the first point. Is there anything wrong with your communication and setting the expectations right in the market. So the market isn't surprised by these kind of relatively bold moves. That will be the second question. The third question, and that's something which I applaud. You've got something within your Board of Directors, a transaction committee. Very obviously, you want to move beyond having 2 major products, even though the second product may be a pipeline in itself, but we have to wait and see. But has this transaction committee refused any suggestion of Mr. Sijmen de Vries as CEO in the past year. So I would like to know, maybe he's too optimistic, too aggressive and you're putting your feet on the brake or the other way around that there's nothing to be found so far. There's nothing to be approved or disapproved.
Richard Peters
executiveThank you for these 3 excellent questions. Regarding the share price and a question about our communication strategy. Sijmen, do you want to address that?
Sijmen de Vries
executiveMr. [ Keyner ], of course, I would like to address that and indeed, I agree. If you look at the history of this company, of course, we were very much in survival mode for a long period of time. I don't need to remind you of that. Then the company, very quickly, became very profitable. And then, of course, we started to invest quite heavily in our new product, which of course is a necessity if you want to continue to accelerate the growth and derisk the company. However, when your profits go down, that's often not very well understood. That's the first thing. And I think that is one of the things that continues. I also see a lot of people asking questions about the level of our operating expenses, of course, that we have become a loss-making company in 2023, and we don't give any guidance this year on any profitability. This comes with the part -- and again, that you have to invest into the future and investing in launches of products. It tells you that the commercialization is a very expensive business. Investing in launches of products is always costing very much a lot of money. And you will have to basically, for lack of a better word, dig a hole before you get out of that hole because the product starts to perform. Joenja will perform and you can see it's already performing, but it will take a lot of investment. And that means that it is also difficult to understand. Also in the context, and I think that's the other element here is that [indiscernible] of rare diseases is even more of a challenge where in hereditary angioedema, we have a lot of competition. We have no competition in APDS, but we have to find the market. And that takes money, but it takes also time. And that's the other element, I think, that the market is always looking for more and more quickly. And here in also rare, the markets doesn't sort of believe the story yet. I think, I believe it's maybe not the right word, but doesn't perceive the story yet. And so I think we are very confident, and we also know that there is quite a few of institutional investors already invested in the company. You saw one of them sticking up above 5% briefly last year, which was a quick sign of confidence and they quickly built a position in the market. But we also know that quite a few of these names are below the 3% threshold. You don't see them because they are still sitting "on the fence" for lack of a better word. But we do get a lot of traction. And I was again last week on [indiscernible] roadshow in New York, where most of these investors are after the first quarter results, you see a lot of traction with the institutional investors. But traction and actually picking up the shares is, of course, a different thing. So the market is impatient, has not got a lot of patience, but you need a lot of patience. But we are very confident in the growth story. And yes, we are all the depressed about share price, but.
Unknown Attendee
attendeeIf I may react Mr. Chairman. I would like to react. And the latter part, you say, okay, the market show me first, and then we believe then we appreciate the share price, as we all wish it would be. The first part of your answer, I'm not so happy or convinced about. Your first part you're explaining very well we're still in investing mode, and that shows also that's why we're not so profitable anymore. Maybe a lot of investors would have liked to hear this story 1 or 2 years earlier. And if your answer is investors hate these kind of stories, I'd like to refer you to a company like Amazon.com, for years and years, they've been in investing mode, not making any profit, no cash flow whatsoever just investing, investing and the market appreciated this company like [indiscernible]. So it is possible if you got a strong story, a convincing story that some shareholders will believe it and appreciate I want to buy and hold to those shares. So I'm not so happy with the first part of your answer. The second part, I understand that the market, they understand your story, but they say, "Well, let's wait and see because a lot of examples in your sector in your industry, but the stories have been great, but in the end, the results have been disappointing.
Richard Peters
executiveThank you for that feedback. Thank you for that feedback. I'm going to move on to your second question, which was around the refinancing into the convertible notes and the reaction of the market. And is there something wrong with our communication strategy? Or could we do better? By the way, I always think we can do better. So I agree with you. And we're always constantly in the learning phase and trying to do better. So with regard to refinancing the convertible note, I will tell you that we were all involved in this decision. We knew it was not going to be an easy thing to do. But we are thinking long term about building value for the company. And by strengthening our cash position, it allows us over time to really look at -- and we should back to your third question around the transaction to look at potential targets and pull the trigger whenever we're going to be ready for that opportunity. So it was a matter of like figuring out how hard do we position the company for optimal success, not necessarily short term. We could try to manage the company on a weekly basis, on a monthly basis for the share price. But our role as a Board is to really manage the company and work with the management to put the company on track for long-term value creation. I don't know if Jeroen or Sijmen want to comment on the reaction of the market to the convertible notes?
Jeroen Wakkerman
executiveYes, so share for -- Yes, so share price has been indeed going down for a while now. And in that period, we also issued the convertible bonds. We had expected a short bounce of the share price, which is normal for convertible bond transactions, and we saw that as well. And, yes, so you mentioned the dilution, and that's indeed because of the parameters of this transaction the -- well, the premium or the conversion price is lower than it was the one from 5 years ago. And that's just basically reflecting the current status of the market. So there's nothing we can do about that. That's basically what happened. But overall, we're very happy that we safeguard the balance sheets that we secured funding for the next 5 years. And if you look at the cost of this transaction with the coupon of 4.5%. That is very competitive. And if we have done different ways of refinancing, it would have likely been much higher cost.
Unknown Attendee
attendeeThe third question?
Richard Peters
executiveI'm going to go now to the third question, which was the transaction committee and whether we have refused some proposal or presented to the transaction committee. We do have the Chair of our transaction committee here, Barbara Yanni, and we'll let you comment on that.
Barbara Yanni
executiveYes. Thank you very much for that question. I think we -- I can tell you, we look at transactions very carefully. We have a strong group within the company that filters -- looks at transactions filters them down to something that would be interesting. It's -- I have a long history of being in the business development world, and it is very, very hard to find appropriate transactions. And -- but to your specific questions, have we turned down any of Sijmen's ideas? No. Maybe some people on the other side have turned down our ideas on how much we're willing to pay or whether how we might want to structure a transaction? So I think we look carefully. I can tell you that we want to find appropriate transactions. They're hard to find. There's a lot of competition for products or potential products that might be out there. So I think we have -- I feel good about the process, and I don't think we've missed anything that we could have done. And -- but we will keep our eye on what's out there.
Unknown Attendee
attendeeThank you. Let me applaud a kind of mentality of not overpaying out of a kind of desperation. That's much better even than I do at least I hope you do, that the biotech sector, big tops and daily troughs as well. And of course, timing that one is a very delicate matter, it's better to be a little bit more patient and then take the step if it's appropriate instead of you feel the pressure of everybody, you need to make sure you got 3, 4, 5 products in license and whatsoever. Maybe that will boost the share price. The risk of overpaying that can be a big burden indeed.
Richard Peters
executiveWell, thank you for those comments. And again, it resonates what I was saying before is that we are looking to build value long term. And we can afford to be patient because we strengthened our balance sheet with the convertible loan. Are there any other questions in the room here before I go to online. Please state your name and your affiliation, please.
Unknown Attendee
attendeeYes. Good afternoon. My name is [indiscernible]. I have a couple of questions, which I would like to ask. But first of all, congratulations on the approval of the country Israel for Joenja. Very nice to hear that. Last year, the Pompe research was stopped. Does it also mean that Gaucher and Fabry will not be started up or this also stopped with that?
Richard Peters
executiveThank you for that question. Sijmen, do you wish to answer?
Sijmen de Vries
executiveThat's correct, [indiscernible].
Richard Peters
executiveAnd that's already a competitive market, the Pompe market. Is that the main reason? Or is it a more technical reason for stopping this research?
Sijmen de Vries
executiveBoth.
Unknown Attendee
attendeeOkay. Then a question on the RUCONEST revenue. There's a population using RUCONEST as their first medication and there's a part of the patient population that uses RUCONEST as C1 on board. Can you tell anything on the percentage of these populations and their repeat sales as someone who has C1 on board by every year or once or twice or how does this work?
Richard Peters
executiveSijmen, do you care to answer?
Sijmen de Vries
executiveYes. So obviously, on an anonymized basis, we can follow our patient journeys. We do not know though how or in what context the patients are using the drug, right? So if you think about U.S. patients that are either on acute only or also on prophylaxis, we do not know that. We, however, see that we are serving the average use of RUCONEST per patient is much higher in RUCONEST than we see in all of the other products. And in combination with the fact that all patients that are RUCONEST failed or all other therapies, you can see why we are in a very special segment of that market that actually patients do need to use RUCONEST. So the other treatments, we said this many times before, the other treatments that are on the market are much more convenient, right? There are oral sometimes or they are subcutaneous. But RUCONEST is the one that they are relying on because that is basically speaking, the missing protein that they are replacing, and therefore, you see the results. It doesn't come that much closer to 100% than you see with the RUCONEST clinical trial results. Hence why RUCONEST continued to play that special -- very special role in that segment plus we see -- we think we see because we never know for sure, as I said before, where we see patients that are using less -- RUCONEST less frequently, and we suspect that we are also making more and more inroads in the segment of breakthrough medication. Especially in the context, we think, and we don't know, that could be the case where, for instance, an oral prophylaxis enter the market where there is significantly breakthrough attacks than on the brake -- than on the Gold Standard Takhzyro, for instance, that was in the market for prophylaxis. So in other words, we do not precisely know, but we have our suspicions any combination with -- that they all failed on everything else before they went to RUCONEST.
Unknown Attendee
attendeeAll right. I didn't know that there was not -- you are not able to make a distinction between the patients.
Richard Peters
executiveYour third question?
Unknown Attendee
attendeeYes. On the first indication or study or patient finding that has been done. What is the process for the FDA to approve this? Or because it's not in the pipeline as a study, for example.
Richard Peters
executiveSo you're asking a question around the life cycle management of Joenja, which Anurag mentioned?
Unknown Attendee
attendeeYes, for the first part. So there's 1,100 possible patients. And when -- are they -- is it okay by the FDA? Is the latter or how does that work?
Richard Peters
executiveAnurag?
Anurag Relan
executiveYes. So for the patients who have this current VUS result, it is basically an inconclusive result. And we are doing further testing to be able to categorize those patients as having APDS or not. So once they're diagnosed with APDS, then they fit under the current label. So there isn't any additional clinical trial work and that's why it's not listed under the pipeline segment because they are basically a group of patients who don't have APDS yet. But in the future, with further testing, may be diagnosed with APDS correctly and then be eligible for treatment.
Richard Peters
executiveMay I ask -- before you ask any additional question, may I ask to see if somebody else has any questions. I just want to be fair. Yes, there's somebody behind you.
Unknown Attendee
attendee[Interpreted] Yes. My name is [indiscernible]. I'm a private investor, you do testing, but I get the impression that you are paying for all the testing, than patients are paying for the tests. So that must cost tens of thousands of euros.
Sijmen de Vries
executiveThe tests are paid by us. That's correct. The genetic testing the gentleman suggests costs tens of thousands of dollars. No, that's not correct. A couple of hundred dollars are the costs for the tests, which we indeed carry, so a couple of hundred dollars per test.
Richard Peters
executiveYou have other question?
Unknown Attendee
attendeeYes. I have two more, if I may. Yes. One is on the OpEx. Also kind of referred to that. What we see is there's a lot of costs involved in investing for a new product. How does this work in future, you are in the U.S. market now. European market might be opened this year. So does that also mean then there's more investing needed also for Japan or rest of the world? Are you keeping on investing for the next couple of years?
Richard Peters
executiveSijmen?
Sijmen de Vries
executiveYes, to a certain extent, of course, yes. First of all, it will be market by market in most cases, right, because reimbursement will take considerable time in some markets and somewhat short in other markets. Then the level of investment will be significantly lower than in the U.S. market. We already have a great deal of infrastructure on board with regards to the European markets. We also have [indiscernible] person even in Japan for the clinical trial and for the patient finding going on already. We also have 1 person employed in Australia already for the same reason, so we are. And for Southeast Asia, certainly Southeast Asian patients finding activities where they are on either of these early access programs either paid or not paid. So there is already a lot of this activity going on. So in other words, investment continues. Does investment significantly increases going forward, we do not expect that. Jeroen also gave some guidance on that in the first quarter results and at year-end last year as well. But it is in the story of investing, but you also see that when the sales grow, you can very easily see that we very -- in the very near future, will become a profitable company again.
Unknown Attendee
attendeeYes. And then in respect to new licenses, does it mean that the investing part will be 30% lower because you already have more infrastructure available? Or does per license, you need to invest just as much as now with the Joenja?
Richard Peters
executiveAre you talking about licenses of line extension of Joenja itself in other indication? Or are you talking about other products?
Unknown Attendee
attendeeNo in-licensing of new products, I mean, so would that be the same investment amount or because as an investor looking at the company. Oh, yes, there's a lot to be invested there. If you buy -- after we buy, let's say, a license for 2, you need to invest [ 10 ] and with the new license, then need to invest [ 6 ] or?
Richard Peters
executiveDo you want to answer?
Sijmen de Vries
executiveIt depends entirely on the situation, obviously. As you saw with Joenja, we added another sales force, but the back -- the supporting side of the U.S. organization, which was the majority of colleagues on board in the U.S. did not have to be significantly expanded. So in other words, it's a very scalable model that we have. And that's the beauty of operating in these rare diseases because it's very scalable. And every time, let's say, you add -- a product you add for instance, sales force in the U.S. and Joenja sales force is 24 plus 3 sales leaders. And Anurag get a few other medic support as well and maybe the old marketing person. Now I'm simplifying it a little bit. But it means it's a very scalable model. And you can see why adding on another product will indeed bring on by the time that product comes to the market, we'll indeed bring some expansion to the organization and ditto for the other markets where you are commercializing but not so much in that respect.
Unknown Attendee
attendeeIt will put the product in the bucket of the salespeople already there?
Sijmen de Vries
executiveYes. Of course, before that, you do invest in clinical trials, of course.
Richard Peters
executiveThere is some -- there's a gentleman right behind you, I think, he wants to ask a question.
Unknown Attendee
attendeeShort last question. Because -- well, Joenja, I'm quite amazed by the new indication, had the possibilities if you look at statistical numbers from research down, then almost the term blockbuster comes to mind for the product. It has thousands of people. And if the prices at that level are almost the same as in the U.S. for Europe. Are you thinking as Joenja being a blockbuster in the 5 to 10 years.
Richard Peters
executiveI can answer that and then you can answer. So I know a little bit about rare disease having run the global rare disease business at Genzyme. This is interesting about rare disease. You develop a drug and then all of a sudden, you start finding patients that can become way more eligible for the drug. So when I actually was looking at joining the Board of Pharming, I was very interested in the Joenja opportunity, we talked about this because I saw it as a pipeline within a drug, which I think you picked up on. Whether we will reach blockbuster level or not, we don't know yet. But I think investing right now, going back to the earlier questions, investing into the product in doing life cycle management not only in terms of testing, but also looking for adjacent, what we call adjacent indications is the important investments that we have to make for the company. You are bringing gifts?
Unknown Attendee
attendeeA little gift. Yes. Can I put it first in front of you.
Richard Peters
executiveThank you very much.
Unknown Attendee
attendeeThank you for your plans. But I like -- I don't have a question, but I want to say something. If you don't mind, I will do it in Dutch. We are a Dutch company. We are beside [indiscernible] a nice place here at Leiden. So if you don't mind, in Dutch. [Interpreted] So at the beginning of this year, we were made happy. You gave us an update. And have all to myself same, you almost kind of guide to 180 million to 195 million. You have a sense of humor, you're only talking RUCONEST, but we sold the figures for the first quarter. And I believe -- well, I have to be honest, I'm very disappointed. Now it is very strong that you are behind your team, that you are behind your company and that you give us guidance and you gave us the figures for RUCONEST. And at the beginning of the year, we had the update, and we thought that RUCONEST is a fantastic product, it is out there. People understand and that's why I gave you the flowers. It's for your team. And there are 3 feathers in it by a peacock. You can use it as a metaphor, but I put them in the flower. And for me it represents the hereditary angioedema and APDS and amongst from that PID. So your 3 major drugs when it enters Phase II. I could add 2 feathers in your cap, the VUS that you will have at the end of the year. Really, it should be above PID because it's going to be a big boy, I believe. And then in the third quarter, you came up with the in-licensing story. We could add it though. So 5 feathers in total how about that? But those 5 feathers or 3 that we have right now should be fully used for your patients. As a shareholder, we have to be patient as well. Right now, it's difficult to stay above the [ $0.80 ] threshold or cutoff point. So they represent patience. And I want to bow to you, bow to your patience that you have to exercise to talk to all of the bodies and work with them. And I don't have to name names right, and I'm curious to learn maybe next week, you get the bill. And there will be $10 million on that bill, will you just add a PV to it of all sorts. And it's PV, is a priority voucher, of course.
Richard Peters
executiveYou, all, [indiscernible], for those of who you are online, who don't understand Dutch. This is a very nice gift from one of our shareholders, presenting us flowers for the team, thanking us for our patience, but we also thank you for your patience because it's rare disease, it takes time to build the business.
Unknown Attendee
attendee[Interpreted] I know. And of course, you have the cost before you have the income, not the other way around. But it's disappointing here in Europe, of course, for sure. But that's what I wanted to share with you, but let's add positivity. We can all use it.
Unknown Executive
executiveThere's one more question in the room? Yes.
Unknown Attendee
attendeeYes. All this positivity. Maybe a few more comments from my side. My name is Keyner, behalf on VEB. I've got 2 questions concerning your products. The first one concerning APDS, you've been writing, also presenting today that there may be similar diseases, which may give similar or even much similar -- much larger opportunities for your product in the future. Now I've been an investor in plenty of biotech companies for the last more than 3 decades, not in Pharming not allowed to, maybe otherwise I would. And what I've learned from [indiscernible] exactly what I'm going to say right now, from earlier experiences, I can say that all of the companies who had one successful product. For instance, in autoimmune diseases like, I don't know, multiple sclerosis is very, very similar to RA or [ CU ] or the Crohn's disease. So far, I've always been very disappointed in the fact to the degree to those companies being able to address those kind of different markets, even though the diseases have got lots of similarities and so on. My question to you is to what degree are those APDS family members very different or more similar than the examples I've been seeing in the past 3 decades.
Richard Peters
executiveAnurag, do you want to answer that question?
Anurag Relan
executiveSure. It's actually a very good question. And when we looked at the spectrum of opportunities with leniolisib, there is so many different choices. There were autoimmune choices. Novartis at 1 point was thinking about rheumatoid arthritis. We really try to focus and look at targeted therapy, right? So we have targeted therapy for Joenja in APDS, and what we said was where else can leniolisib rationally applied where it -- this class of drugs hasn't been evaluated before or it's not just some large disease like inflammatory bowel disease or rheumatoid arthritis. And what we found was that again led by the immunologists who came to us, so not -- our team even looking at this, they said there are these other primary immune deficiencies that have a similar immune dysregulation phenotype. That's number one, so the clinical features are the same. Number two, they measure the pathway, and they see the increased activity of that pathway. So if you remember the name of the condition APDS is activated PI3K delta syndrome. So these other patients also have that same type of activity in the pathway. And then number three, they use medications like they use for APDS in these patients too, not successful -- not great success because of the tolerability of those medications, but they tried to control it in the same way. So together, all of those things suggested to us that there was a real opportunity here and that it's probably not the type of risk as going into oncology or going into rheumatoid arthritis. And that's one of the big reasons why we said, okay, this is a well-defined population and it's a -- and we're using a targeted approach to control that pathway and which gives us a lot of confidence in trying to conduct this study. And I mentioned in our quarterly call, too, is that this is the second indication. There is a third also that we're still working on. We haven't disclosed it yet, but I hope to be able to do that later this year with even, again, same type of scientific rationale.
Unknown Attendee
attendeeI have to disappoint you. I'm not a doctor. I'm an engineer, nobody would believe it, but actually, I'm an engineer. I cannot touch whether pathway and so on is relevant. I have to believe you. Maybe to put it in layman terms, is it correct to assume that the family ties between the APDS similar diseases, the family ties are stronger -- more stronger than they are between RA and multiple sclerosis and [ CU ] and so on. Is that a correct assumption I think in layman terms?
Anurag Relan
executiveI think that's true, but I think what's even probably important to answer your question is conditions like rheumatoid arthritis, inflammatory bowel disease, they're much, much more complex in terms of our understanding of them. There's so many other factors, so many pathways involved here. We're talking -- we think that we have a better understanding of what leading in this inside the cell to the clinical part. That's really, I think, the answer to your question.
Unknown Attendee
attendeeThat's an answer, which even an engineer understands. I've got the second question, Mr. Chairman, if you allow me to. That's maybe also something which you tried to answer of the previous person, not the one with the flowers, this person here. It concerns for virus. And you already explained in your presentation there's lots of competition, but somehow, RUCONEST seems to survive and needs -- you're capturing your market share because you are by far, the most effective -- not maybe the easiest to apply, but the most effective treatment you can imagine. So this kind of market share is more or less protected. What makes you think that Pharvaris is similar to the other competitors who are already on the market.
Richard Peters
executiveAnurag, do you want to answer that question?
Anurag Relan
executiveSure. So the drug that Pharvaris is developing is called a Bradykinin 2 receptor antagonist. It's an oral bradykinin 2 receptor antagonist. But there's already an oral -- there's already another injectable bradykinin 2 receptor on the market, and it's been on the market for more than 10 years. That is a product called Icatibant. The trade name is FIRAZYR. That product, and Sijmen mentioned, many of the patients, if not all, of the patients who use RUCONEST have already tried that product. And the reason that they use RUCONEST is primarily because of that efficacy or the lack of efficacy they see with that product. Nothing wrong with that product. It works great from most patients, but for many patients, it doesn't. And this oral product is just a new version of that injectable product, but it has exactly the same target.
Unknown Attendee
attendeeIn addition, let me as an engineer add to that for the other people who don't know anything about medicines. Normally, usually it is that oral medication is less effective than you do it by injections and so on, it goes directly into the blood. So by definition, this unlikely will be more effective than the one which already exists for 10 years.
Anurag Relan
executiveThat's correct. I think that's a fair general statement.
Richard Peters
executiveAll right. Are there any -- oh, there's one more.
Unknown Attendee
attendeeI'm [indiscernible]. Mr. -- you gave an outlook of the total revenues, but you did not give an outlook of the total costs and costs are easier to manage by you than the revenues. So why don't you give an outlook about the cost?
Richard Peters
executiveThank you for the question, Sijmen or Jeroen, Jeroen?
Jeroen Wakkerman
executiveYes. Thank you for the question. So basically, we did give some guidance in earlier calls, and that was along the following lines. Last year, in Q4, we had a big increase in cost. It was $73 million in the fourth quarter. And what we said is we will not repeat that. So on average, the cost on a quarterly basis in 2024 will be below that $73 million level. How big exactly is going to be, we don't know, but we are managing towards that level, so not to get above $70 million per quarter this year on average.
Richard Peters
executiveAre there other questions here in the room? A couple of more people, yes, please go ahead.
Unknown Attendee
attendee[Interpreted] My name is [indiscernible]. How do you recruit patients? Are they referred to you by a doctor? Or can they just sign online, for example, because you were saying that they sometimes change medication. Does the doctor need to give a prescription for that? Or can you as a patient or a private person just use the drug for $550,000 because I think first, probably you need to have the disorder, right?
Richard Peters
executiveTranslate it and then answer the question.
Sijmen de Vries
executiveYes. So the question is, how does that work with Joenja patients, right? I assume you're asking, is there a prescription necessary? Or can you just get the drug? Well, there is -- of course, first of all, there is a genetic test that has to be confirmed that you have APDS and this hyperactive pathway. And then, of course, and this is done by highly specialized doctors. Then of course, there is a necessity for a prescription and a prescription then will go to an insurance company and will have to be approved. And you have seen that we have a very high rate of approval for those prescriptions. So it is on prescription only by highly specialized doctors. I hope that answers your question.
Richard Peters
executiveNext question? Yes.
Unknown Attendee
attendeeI'm [ Jan Hoard ], shareholder from 2008. So my patience is enormous. But I hope one thing and I go now to Dutch now. [Interpreted] Now that the share price is so low, I mean you want to take over companies you say, aren't you afraid that someone might go after you that you might be taken over yourself because -- that is my question as what I fear the most. I've been sitting and waiting quietly for such a long time. So why -- I mean there's -- there have been people here who said, "Well, it needs to be more robust. The communication needs to be better," and I agree with that, I have to say. So how do you view that yourselves?
Sijmen de Vries
executiveMr. [indiscernible] is asking, have we become -- with the low share price [indiscernible] afraid you a takeover target and says that maybe we should communicate a little bit more robust about this. So to actually have not -- so bring the share price up, I suppose, and be less of a target.
Richard Peters
executiveSo I will -- can I answer in English? So takeover target, any company can be a takeover target. And we don't make -- we don't comment on these kinds of things that could happen or not, we want to build a sustainable, independent rare disease company, everybody in this room here, that's what we want to do. We are an independent rare disease company that now has a portfolio of products with 2 products, and we intend to expand on that. So then comes the question of the share price, which was already asked earlier. It is a subject of frustration for all of us. But at the same time, we have to build the fundamentals of the business. And as we prove that we can actually execute on the fundamental business and build a diversified premier rare disease company, then eventually the share price should follow. When will that happen? If I knew that, I would be buying all the companies in the world because you cannot predict the markets. The best thing we can do here is to run the business as disciplined as possible, build it for a long-term potential and then over time communicate constantly. We also want to make sure that we don't overpromise. Some management teams and some boards get so desperate, they start overpromising and then that's -- you can run to real problems by doing that. So I think the way we've been running the company, both as management and as the Board, we've been very, very respectful of our shareholders and of the rules and regulations.
Unknown Attendee
attendeeWhy I chose you as my investing. You have profit, you have a product, you have -- now okay, losses this year may be and you -- yes, [indiscernible]. And that's the 3 things I believe in because I'm also holding by myself. But I have one question to Barbara or to all of you. You are looking for new indications, but you say no, you have [ $100 million ] [Interpreted] You say the loan has been $100 million. You've got money in the bank. What is the amount of the indications you're looking for? Is it $10 million, $20 million, $500 million, you never really say that. And let's say you were to have an indication right now, and you'd need to pay maybe $400 million, then you've got a huge dilution.
Richard Peters
executiveBecause I understood that. So the question was, well, you've got this convertible note that we did. And then we're looking at potential acquisition, what is going to be the size of these acquisitions? Is it $10 million, $20 million, $40 million, $400 million. We are -- basically, we have a clear strategy what we are looking for with -- led by the transaction committee. And we've given that the guidance to our management team. It is based first on the quality of the asset, right? And then once we find assets of high quality that we fit well within our portfolio within the company, then we look for a price that would be acceptable to us. And as you heard from Barbara, it may be acceptable to us, may not be acceptable to the other party that wants more. So we're being very disciplined about that. As far as the size, that remains to be determined based on the opportunity. Do you want to add anything to this?
Sijmen de Vries
executiveNo. I think to summarize it. And of course, it's all rare diseases, right? You have to realize that as well. On the other hand there, as Barbara has alluded to, there's a lot of competition around all this, and they sometimes pay crazy prices.
Unknown Attendee
attendeeYes, but I hope they should not pay crazy prices. [Interpreted] Thank you very much for the past year. I thought it was very exciting, and it's going to be another exciting year, I think. But certainly, thank you very much for the past year. I think you're very welcome.
Unknown Attendee
attendeeMr. Chairman, Keyner of VEB. I've got one more question based on your earlier response. One advantage of being here, I think, for the 21st year or so, I've said maybe 1 or 2 years, but most have been here during all those difficult times as well. But I do remember, Mr. Sijmen is very clearly explaining your strategy, almost like a religion about being taken off or not. And remember, very, very clearly, his explanation was 2 and 3 and 4 or 5 years ago have we repeated the same story or similar questions like the previous gentlemen. We are not against being taken over. However, for us to be able to get a good price for being taken over, need to build a portfolio big in 1 product. Now been listening very carefully since that maybe there's a nuance right now and saying, we want to remain independent, of course, on the market. But has anything changed as far as that is concerned that you're saying want -- our goal is to remain independent to build our own portfolio, to keep our future in our own hands. And it will be very unfortunate if anybody would take us over for any price.
Richard Peters
executiveI didn't say that. I said that we want to build an independent company. Companies are not sold, they're bought, right? And so our goal is to build the best company possible. We also know as a Board that we have a responsibility to maximize shareholder value. So if somebody were to decide to make a play for the company that makes sense for our shareholders, we would have to look at that very carefully. But again, companies don't get sold, they get bought. Why do they get bought because they built the quality. It doesn't look like there are any more questions here. Oh, there's one more in the room. Yes, sir.
Unknown Attendee
attendee[Interpreted] I'm also going to be speaking Dutch, since that's easier. I've been here since 2011, so not that long with still. In view of my -- with the people behind me, it's a large group. The question is, was it a rebound new because of the convertible instruments and it was expected to go down? And my question is, over what period this year, will there be a rebound upwards? Or do you not know when I'm asking that because I have quite a lot of people behind me. It's a short question. And of course, no one can predict the future, but still.
Richard Peters
executiveCan you translate and then.
Sijmen de Vries
executiveYes. The question is whether we expect the share price that has been hit by, let's say, for instance, market conditions, but also a convertible bond because there were also very negative market conditions for the entire biotech sector recently. That -- whether we expect that to be over now or to continue. And of course, Mr. [indiscernible], it is very difficult, as you know, to predict. We, of course, believe that we continue to execute on RUCONEST and Joenja that the market will catch up eventually. When that will be is, of course, not very clear because otherwise, you wouldn't sit here if we could predict share prices, right? Maybe, Jeroen, do you want to add something to that?
Jeroen Wakkerman
executiveI concur with that. And the normal price reaction -- share price reaction to a convertible bond is over a week or so. So the market just needs some time to adjust to the volume that is created by the issuance of a convertible bonds. That time is over now. So now it's up to the market to determine where the share price is going. But it's not related that much to the convertible anymore normally.
Richard Peters
executiveCan you state your name as well for the recording...
Unknown Attendee
attendee[indiscernible] The fact is for financial. [Interpreted] that fiscally speaking it is still going up this year. Is that something you see is effect or not? I get that question a lot, of course, from private investors, not from companies investing because, of course, in the Netherlands, we deal a lot with shareholder owners.
Sijmen de Vries
executiveWe cannot predict the share price, obviously. We have -- for this year, because you ask if this fiscal year, there will be changes. We have half year results in August, we have third quarter results in October. So there's two opportunities. There's many more opportunities for shareholders to let you on to more positive news with regards to execution and all sorts of things you heard about. So we are optimistic about this, but we don't know, is the answer. I'm sorry.
Richard Peters
executiveDug well. By the way, for those of you who might be listening online, if you hear a lot of background, I think the sky is hauling on us. It's raining a lot here in the Netherlands. So if you hear some backgrounds, that's what you're hearing. Are there any more questions here. Yes. No. Great. I was also notified there are no questions online. So therefore, I would like now to close agenda Item 2A and ask Steven Baert, the Chair of the Remuneration Committee to present to you the Remuneration Report for the year 2023. This report is included in our annual report and on today's agenda as Item 2B. Steven Baert?
Steven Baert
executiveThank you, Richard, and good afternoon to our shareholders. Apologies for joining you remotely. My daughter graduated from university. And as a proud father. It's very important that I could attend the ceremony in person. So I trust you will understand my decision. On behalf of the Remuneration Committee, I will present to you the Remuneration Report of Pharming for the financial year 2023. This report, the Remuneration Committee reports on how the remuneration policy for the Board of Directors was implemented. You will have noticed that the Board of Directors has submitted a new draft remuneration policy for adoption by our shareholders. And during today's meeting, I will come back to that under a separate agenda Item #3. The Remuneration Report was submitted for today's meeting, still covers the implementation of the existing policy in 2023. The Remuneration Committee very much appreciates the highly positive advisory vote at the Annual General Meeting of last year held on the 17 of May 2023, where 95.05% of the votes were cast in favor of the presented report. And as such, I'm pleased to confirm that we have maintained the same template for this year's report and even added several other disclosures to ensure continued alignment with best practices and to meet feedback from shareholders and proxy advisers. For example, we included an explanation of changes made to the peer group in 2023. And an extended clarification of the reasons for the increase of the base salary of the Executive Director. In addition, the vesting schedule applied for the short-term and long-term incentive plan to determine payout and vesting percentage for each of the quantifiable targets, now include a threshold of 80% for each quantifiable target. Furthermore, the Board of Directors has undertaken action to ensure that dilution limits for Pharming due to the equity plans for staff and the Executive Director will be prudently applied. And that in any event, grants of equity or equity rights under these plans will not result in Pharming exceeding 10% of all issued and outstanding shares of Pharming on a diluted basis. Last but not least, from the 2024 short-term incentive plan onwards, we will get a full retrospective disclosure of all targets and apply a 50% weighting for financial targets. We will continue to monitor the need for further appropriate changes to our remuneration design and disclosures to ensure a high level of shareholder support. Before sharing you a few highlights regarding implementation of the remuneration policy in 2023. I would like to ask your attention for some important activities of the Remuneration Committee during the year 2023. Firstly, as already announced in last year's Remuneration Report, the Remuneration Committee engaged AON Radford, as international compensation expert, for a new market review of the compensation of the members of the Board of Directors, including the fees of the chairs and the members of the committees, The resulting proposals have been included in the updated remuneration policy, which we will further explain under agenda Item 3. The Remuneration Committee furthermore engage Georgeson, as international strategic consultant, for the review of the 2022 and 2023 Remuneration Reports and the Remuneration Policy for the Board of Directors, respectively, to ensure continued alignment with market practice and applicable rules and regulation. Also, we consulted proxy advisers on the proposed changes and their feedback has been considered. I already mentioned the resulting additional changes that were made to the 2023 Remuneration Report, under agenda Item 3. I will, as said, explain to you the new Remuneration Policy for the Board of Directors. Looking at the implementation of the Remuneration Policy in 2023, the Remuneration Committee was pleased to note that Pharming had a positive year with solid full year financial results, including significant growth in RUCONEST in the revenues. And of course, the launch of Joenja, leniolisib for APDS in the U.S. In April 23, shortly after the FDA approval on March 24 in 2023. In doing so, Pharming continue to deliver on its strategic objectives that are aimed at serving the unserved rare disease patients and becoming the rare disease company of choice. Translating those results to the targets that have been set for the CEO for the year 2023, the Remuneration Committee calculated a total score of 130.5% on all financial and nonfinancial targets. A summary of the financial results in 2023 for the short-term incentive plan is now being projected on the screen. These results reflect the company's strong financial performance over 2023. I also invite you to read the detailed scorecard on all financial and nonfinancial targets, which can be found on Pages 96 up to and including Pages 99 of the Annual Report. According to the Remuneration Policy as adopted by our shareholders an on-target performance by the CEO results in a payout in cash equal to 70% of his gross annual salary. With a maximum payout of 140%. So the Remuneration Committee multiplied the total of 130.5% score by the 70% on target score, and this resulted in a gross cash payment to the CEO equal to 91.35% of the fixed annual salary for 2023. For the long-term incentive share plans, the first set of conditional shares awarded to the CEO for the performance year 2023 -- sorry, for the performance period 2021 until 2023 was scheduled to vest in the first quarter of this year. The vesting percentage is based on the performance by the CEO against the long-term targets that were set at the start of this performance period which were a combination of total shareholder return, which has a 40% weighting and strategic corporate objectives, which have a 60% weighting. The Remuneration Committee concluded that the CEO had satisfied 99.5% out of the 100% of the corporate strategic objectives. Detailed scorecard again can be found on the Pages 101 and 102 of the annual report. The score on the total shareholder return compared to the AScX Index and the NASDAQ Biotechnology Index resulted in unfortunately, vesting percentage of 0%, as a result of the share price performance. Applying the weighting percentage of 60% to the score on the corporate strategic objectives, all of this results in a total vesting level of 59.7%. And therefore, a total number of 789,719 (sic) [ 798,719 ] shares that vested for the CEO in the first quarter of 2024. The CEO is required to retain these shares for a total period of 5 years as from the moment that these shares were granted in early 2021. More details on the CEO's total remuneration package for 2023 can be found on the Page 95 of the Annual Report. Finally, I would like to make a few comments regarding the salary of the CEO for 2024. The Board decided to increase the fixed salary of the CEO by 3% from EUR 624,000 in 2023 to EUR 642,720 for 2024. This salary increase takes into consideration the solid performance by the Executive Director in 2023, the strong performance delivered by the company over 2023 under the CEO's leadership, the 2023 pay ratio that stayed flat at 12:1 compared to 2022, and the benchmark data provided by AON Radford. This increase is also equal to the average merit increase for Pharming employees in Europe for 2023. We will now answer the questions that our shareholders may have on this section of the agenda. Richard, back to you.
Richard Peters
executiveThank you, Steven. I would now like to invite our shareholders to ask their questions to Steven of this agenda item. Please go to one of the microphones and state your name and if applicable, the name of the shareholder you represent before asking the first question.
Unknown Attendee
attendeeMy name is Keyner. I speak on behalf of VEB. Very clear presentation. 60% of the long-term bonus is determined by strategic objectives. Of course, strategy is very important. 40% by total shareholder return, since there's no dividend, of course, there's the share price appreciation, which hasn't been any. Because this kind of policy close to the maximum 60% of the long-term incentive is being paid out or is being granted. I must say, on behalf of shareholders, this for. This hurts because in the end, the share price development, including any kind of dividend is affect the end results, which encompasses everything that you're trying to do. Its operational excellence, its defining a good strategy, implementing the strategy in a good way, having in the meantime results, which are at least reasonable and a balance sheet, which is not collapsing. So my point is, are you satisfied yourself as the Remuneration Committee, as the nonexecutive Board, are you satisfied yourself that in a period where the share price has been lagging the market overall in a very, very strong way, and that you're granting any kind of bonus at all, and I understand this is the policy. And of course, it's up to you to say, we respect the policy. But in the end, this hurts. And let me give you a -- kind of answer, which I would have hoped to come from the your side. In the end, it's up to you to convince market that your strategy and the strategic objectives are wise that they're helping the company and the shareholders in the long run. That if you're investing right now and if the corporate strategic objectives are being defined and implemented in a correct way. This will definitely lead to a very strong share price increase in the future and maybe even some dividend. Obviously, the market sees it differently. And I was wondering how you see your own and see the result of this kind of policy in the past year?
Richard Peters
executiveThank you for your question. Steven, do you want to answer question regarding the Remuneration Committee and its comfort level with how people are being compensated and rewarded?
Steven Baert
executiveYes. Thank you, Richard. Thank you for the feedback. I think your question is as much feedback as it is a question rightfully so. I would answered in the same line as what Richard said, we are building a rare disease company, and we're building that company for the long term. The plans are designed to do exactly that. So are we satisfied, the parts where we are satisfied in terms of the continued growth of RUCONEST despite competition. The launch of Joenja in the United States, which is a significant milestone to get the product approved and commercially reimbursed. And so from that perspective, the CEO and the team definitely delivered and achieved their results. The part where as the Board, we are also responsible is to make sure that, that ultimately results in shareholder return. As you put your money in the hands of the team to invest. With that part, we were obviously not satisfied. That 40% of the long-term incentives resulted in a 0 payout for the CEO and the team. We could have a discussion whether that mix needs to shift, whether 40% is too little, too much. We tend to look at the markets. We tend to work with external companies that compare various biotech companies. And of course, we are in it for the long game, but I take your feedback, and we will further discuss that as the Remuneration Committee sets the targets and the percentages for next year as we will approach the end of 2024.
Unknown Attendee
attendeeIf I may react, Mr. Chairman, if I may react, because this comes back to my very first question. So assuming that your strategy and your objectives are the right ones. The market is not consisting of only unreasonable people or stupid people. I can prove you that there are lots and lots of companies who had very good strategic objectives and the strategic objective didn't include making a profit or even being cash flow positive. But there was a clear path for the future, addressing -- describing the kind of market, how it would be developing and the way how this company would capture a major part of this kind of market. So maybe something is wrong in the way you're communicating to the market and that may be more you should be -- put more effort or should become more effective in that. Maybe that is the key thing, which is lagging. If not, if not. Why not wait until the results are there, that cash is coming out of your years that you can give a lot of dividend and so. And I can guarantee you the share price will be very, very high. And also your bonus will come back to you. That's also long term. So my point is, we all agree this strategy is very important. And you should also measure the CEO based on strategic objectives. But the end result is always a share price appreciation. It has to be. And you have to explain to the market why this company is worth much more than what it is right now?
Richard Peters
executiveThank you for that feedback again. I think we heard you loudly. Thank you. Any other questions? All right. I'm going now to online to see if there are any questions online. I'm being informed there are no questions online. We will now proceed with the voting on the Remuneration Report for the financial year 2023. 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 been positive. Any votes against the proposal are understood to imply that the report does not meet the expectations of the shareholders. The advisory vote will not be binding, but we will explain in the next year Remuneration Report how the vote of the general meeting was considered. As promised during my opening remarks, I will first explain the procedure for 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 the designated voting items during this meeting. These 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 the press against, if you wish to vote against the proposal or to press abstain, if you will wish not to vote. These votes will not be included when determining the voting results. You will be able to change your vote until the voting round has been closed by me. After each round of voting the total number of votes cast, and the final voting result will be shown on the 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 1,010 shareholders and 75,893,426 shares are represented today and are entitled to vote on all items on the agenda. We will now proceed with the voting on agenda 2B. Our shareholders are proposed to give a positive advice on the presented Remuneration Report for 2023. I have opened the voting. Please cast your votes now. [Voting]
Richard Peters
executiveI will now close the voting. The voting results will be shown on the screens in a few seconds. And I'm pleased to confirm that the proposal is supported by an advisory vote by our shareholders with 95.62% majority. The next item on the agenda is Item 2C on corporate governance. Sijmen, could you please introduce this item and 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.
Sijmen de Vries
executiveThank you, Richard. Thanks. Agenda Item 2C has been included to update our shareholders on material developments in the field of corporate governance. As you are aware, our American Depository Shares have been listed on NASDAQ Stock Market in the U.S. since 23 December 2020. Our ordinary shares have continued to trade on Euronext Amsterdam. Pharming continues to take steps required to ensure compliance with the applicable U.S. regulatory requirements [indiscernible], announced on the fourth of April 2024. We filed that same day, our annual report for 2023 on Form 20-F with the U.S. Securities and Exchange Commission. You can find a document on our website. In addition, we have further significant steps in 2023 for implementing an enhanced internal control framework to ensure compliance by our company with the U.S. Sarbanes-Oxley Act. On Page 66 of the Annual Report, you will find an outline of how Pharming has applied to Dutch Corporate Governance Code in 2023. The slide is now shown on the screen provides a summary of the few remaining deviations that are deemed consistent with the size and activities of the company. Compared to 2022, we report new deviation from the Dutch Corporate Governance Code. This new deviation results from the new provisions included in the updated Corporate Governance Code that entered into force on the first of January 2023. The new deviation refers to the new requirements that we should draw up a policy to facilitate a dialogue with the relevant stakeholders of the company on sustainability aspects of our long-term strategy. While a stakeholder analysis is already covered by our ESG program, the policy is being drafted within the framework of that program, building on our existing investor dialogue policy. We expect to publish the policy on our website this year. To conclude, I'm pleased to inform you that the Board has decided to establish an internal audit function effective this year in 2024 in accordance with provisions 1.3 to 1.7 of the Dutch Corporate Governance Code. As for dividend policy. Agenda Item 2D, Pharming continues to follow its existing policy to not pay dividends. The Board of Directors does not envisage the payment of dividends in the coming years. Payments of future dividends, if any, would be at a discretion of the Board, considering numerous factors, including business prospects, cash requirements, financial performance and product developments.
Richard Peters
executiveThank you, 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 dividend policy. Please go to one of the microphones in this room and mention your name again. And if applicable, the name of the shareholder that you represent. Before asking the first question. I would like to ask Sijmen to answer these questions. Are there any questions? Yes.
Unknown Attendee
attendeeYes. Keyner, VEB. A similar question that I asked maybe a couple of years ago. At this moment, there's one executive in the Board and the CFO, for instance, is not an executive. He's the part of the management team. What makes you decide to continue on this kind of setup? Because I can imagine that as a Mr. Sijmen looks very young and healthy, but at some point, he will retire or we will go to another company. And then suddenly, you have to move even more quickly. Isn't it wise have at least 2 executives in the Board?
Richard Peters
executiveJabine, you are the Chair of Nomination Committee do you want to address whether we want to have 2 Executive Directors instead of one?
Jabine van der Meijs
executiveWhat we do is with these things, we take it very organized, if you like. So last year, when the question was raised, what do we do with our Chair. We said, we're working on that, and that was progress. We now have -- Mr. Peters has joined us, and we are really looking at all the different elements in our portfolio that we think is relevant. And also, on a regular basis, look at things like that. For the time being, we're very happy with what we have. But we do ask questions like that on a regular basis, constantly test our strategy and our -- some of the scenarios that we have available to us to assess what's best for us.
Unknown Attendee
attendeeThat's very good that you assess this kind of things. My question is, why is the result of your assessment that one executive in your Board is appropriate? Instead of 2 or 3?
Richard Peters
executiveWell, I can tell you as the Chairman of the Board, I think we have a highly functioning board at the moment. And of course, the other thing too is that we do meet regularly, not only as a group, but also one-on-one with members of the Executive Committee. So they have direct access to each of us individually as well. So right now, we feel that we have a highly functioning not only Board but also executive team. Over time, we constantly reassess these things. But at the moment, we don't think there is a need for adding an additional Executive Director. Are there any other questions? Okay. Are there any questions online? I've been informed that there are no questions online. We will now proceed with the next agenda item, the financial statements of 2023 as included in the Agenda Item 2E. The financial statements are included in the Annual Report. The financial statements were audited by our external Deloitte Accountants B.V., in accordance with the assignment given by our general meeting on the May 17, 2023. Deloitte has issued an unqualified auditor's report for the financial statements 2023. That can be found on Pages 180 and up to and including 186 of the Annual Report. I invite Ms. Louise Zwama, partner at Deloitte to present the highlights and main findings that followed from the audit by Deloitte. Louise?
Louise Zwama
attendeeThank you. Welcome. My name is Louise Zwama, I'm an Audit Partner at Deloitte. I'm here today to represent Ingrid Buitendijk, who is the partner the Audit Partner that is responsible for signing the audit' opinion to the financial statements, '23. She could not be here. Sorry, I'm replacing her because she's purely abroad and was unable to attend in person. I was not involved in the audit of '23, but I will take over the engagement from Ingrid because she exceeded her 5-year term. Where I say, we, in the short presentation that we have prepared, I mean, the Deloitte order team because, as I said, I was not part of the audit '23. As mentioned by the Chair of the Supervisory Board, we issued our independent auditor's report on April 3 of '24. Both on the statutory financial statements that are filed with the AFM as well as the Annual Report and Form 20-F are filed with the SEC. In our audit report, we disclosed that the management report, including remuneration report and other information, comply with requirements of the Dutch Civil Code and the Dutch Standard on Auditing 720. We report on key audit matter in our reports, that is focus on the U.S. Revenue Rebate Accruals. This is reported as a key audit matter due to the use of significant assumptions and judgments in its calculation. I will explain later what procedures we have done to address this matter. Other focus areas in the audits of '23 included the launch of Joenja. Can you go to the next slide, please. Our materiality is determined based on revenue and slightly increased compared to prior year. It was set at USD 2.6 million, and we have set our reporting threshold to management and the Audit Committee at USD 120,000, or lower if we deem it's relevant for qualitative reasons. We set a component materiality at a lower level, not exceeding USD 1.5 million. Our scope covers the significant entities, and we realized the coverage of 99% of revenue and 98% of assets. For a non-significant entities, we perform analytical procedures. Can you please move to the next slide. The U.S. Revenue Rebate Accruals, specifically aimed at the Medicaid rebates, was identified as a key audit matter. Due to the complexity of the estimates, together with limited historical data available, judgments necessary to develop this estimate and also the control deficiencies identified. Auditing this estimate required both extensive audit efforts and a high degree of audit and judgments when performing auditing procedures and evaluating the results of those procedures. We addressed this matter in the audit by performing a set of procedures. Amongst others, we evaluate the appropriateness of the consistency of the company's methods, data and assumptions used to calculate the accrual. We tested the mathematical accuracy of the accrual. We tested significant assumptions and key inputs used to calculate the accrual. We evaluated the company's ability to estimate the accrue accurately by comparing actual claims received during the year to historical estimates and through the use of data visualizations, we compare it to U.S. Revenue Rebate Accrual against historic data to evaluate the reasonableness of the estimates. And we have no material findings to report. With respect to communication with the Board of Directors and the Audit Committee, we met on several occasions during the year, where we presented the audit plan, management letter and our report to the Board of Directors about the results of the audit. We also have periodic update calls with the Chair of the Audit Committee and management separately during the year. During the audit, we made use of specialists in the area of share based compensation, valuation of the preference shares and around fraud risks. None of these areas gave rise to a key audit matter, which we reported upon in our audit reports. In terms of internal controls, we assess controls that are relevant to the audits. We reported our observations to management and the audit committee in the form of a management letter. The main observations are disclosed in the Annual Report by management on Page 43. Material weaknesses or significant deficiencies were identified over financial reporting across each of the components of the COSO framework, and across the business and IT processes. Pharming is in process of remediating those deficiencies through further development and -- of and implementation of formal policies, processes, internal controls and documentation relating to financial reporting. Our approach with respect to evaluating the IT environment is that IT auditors are integral part of the audit team. Testing is performed by the IT auditors to identify, analyze and test relevant application and general computer controls. And cybersecurity is part of our risk assessment and IT audits. We paid specific attention to fraud risks in the audits. We evaluate the design and implementation of relevant controls, including tone at the top, and paid specific attention to the following elements: How Pharming generates and processes journal entries; how management estimates are determined; the identification and accounting of significant transactions outside of the normal course of business; we held interviews regarding fraud with the CEO, CFO and other senior finance personnel; we evaluated the disclosures regarding fraud risk assessments, management's estimates and uncertainties; and we evaluated Pharming's fraud risk assessments, Code of Conduct, whistleblower policy and incident registration. In terms of addressing risk of compliance with laws and regulations, we performed following procedures: We obtained sufficient and appropriate evidence regarding compliance with laws and regulations that directly affects the financial statements; we were attentive to indications of suspected non-compliance with laws and regulations; we again conducted interviews amongst others, CEO, CFO, Legal Counsel and senior finance personnel; and last but not least, we also read the minutes of the Board of Directors and the Executive Committee. We have no material financial report on that aspects either. The financial statements have been prepared on a going concern basis. This has been disclosed in Note 3 of the financial statements and Note 26. And we performed, amongst others, the following procedures: We evaluate the reasonableness of the assumption used by management; we also took into account all relevant information, which we were aware -- we became aware during the audits, and if those were included in the management assessments; we also reviewed management's future outlook as part of procedures on the Annual Reports. And for the audit of the financial statements, '24, we expect that our procedures will remain largely consistent with '23. Well, this concludes our presentation, and we're happy to answer any questions that you might have.
Richard Peters
executiveThank you for your explanation, Louise. Are there any shareholders in this room who would like to ask questions on the agenda item. Please go to the one of the microphones. And Sijmen, could you please address the questions on the financial statements. I would also like to invite Louise to answer questions on the Deloitte's audit report.
Unknown Attendee
attendeeYes. My name is Keyner, I speak on behalf of VEB. Actually it's the first time that as the partner of a counter company presenting this without having been actively personally involved in the numbers which we are discussing today. I put it more strongly. I'm happy that you're here, by the way, so covering for your colleague. But I was wondering, why didn't you invite? Why don't you send somebody from the team itself? Since they are all very qualified, you don't need to be a partner to be able to say -- to tell the story, I guess, because I think at this moment, there are no major issues from a financial point of view, but if there would be, it would be more than wise that you were involved during the year as well. So that will be the first question?
Richard Peters
executiveLouise, do you want to answer the question?
Louise Zwama
attendeeSure. Sure, yes, we gave it careful consideration. We would be presenting here. I also brought someone from the audit team if we got the detailed questions that my colleague could answer it. And I'm not completely new to the Pharming audits, I was involved a couple of years ago as a director at that point time. So I know the company very well. And that's also the reason why I returned to the engagement. And I've been briefed very carefully by the audit partner and the engagement team on the procedures that we have performed and also the results of the audits.
Unknown Attendee
attendeeWell, welcome back, very clear answer. Now the real questions that I prepared for this session. I'm happy to see that Pharming, and this is very wise as well as seeing the majority of the company at this point. I'm very happy that Pharming has decided to install an internal audit department. That is very important because you sometimes see that companies get into a big mess operationally because the internal controls are not solid enough and they go far beyond the pure accounting stuff and all the admin processes that those are very, very important. I know that you installed it formally, I think, at the beginning this year, but I hope that already some people started last year. And I was wondering whether Deloitte has had any kind of context so far with the internal audit department. And if these kind of discussions so far that you've encountered something which was surprising or remarkable.
Richard Peters
executiveLouise, do you wish to answer?
Louise Zwama
attendeeYes. Yes, I personally also had interactions with the individuals in the internal audit department. As I said, that Pharming is in the process of remediating deficiencies and it's working very hard to get those remediated as soon as possible. And as such, we have, I think, even weekly contract with the internal audit department, making sure that the right steps are taken and that our testing goes along with the progress that the company is making. So far, no surprises, at least not to me. It is a very normal process. The company is following as I see at similar companies going through this process of remediating deficiencies.
Unknown Attendee
attendeeAnd again, I applaud internal department. Thank you.
Richard Peters
executiveThank you very much. Are there any other questions in the room? Great. I have also be informed there are no questions online. We will now proceed with the voting on the financial statements. Our shareholders are proposed to adopt the financial statements for the financial year 2023. Once I have opened the voting on this agenda item, the shareholders in this meeting room 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 to not vote. These will not be included when determining the voting result. I will now open the voting. Please cast your votes. [Voting]
Richard Peters
executiveI will now close the voting. The voting results, including the votes received by means of proxy will be shown screen in a few seconds. And I'm pleased to confirm that the proposal has been adopted by our shareholders with a 99.31% majority. So the financial statements financial year '23 has been adopted. On behalf of the entire Board of Directors, I would like to thank our management and employees of Pharming for their dedication and congratulate them on the results achieved over the year 2023.
Richard Peters
executiveThe next topic on the agenda is Agenda Item 2F. The proposal to discharge the members of the Board of Directors. The scope of this discharge extends to the exercise of the duties during the financial year 2023. As far as this is reflected in the Annual Report, in the financial statements, in other public disclosures or in statements made during this General Meeting. I would like to invite our shareholders to ask their questions on this agenda item. Please again go to one of the microphones if you have any questions. I know there are no questions in the room, and I also note there are no questions online. We will now then 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 of 2023. I will now open the voting and invite our shareholders in this meeting room to cast their votes. [Voting]
Richard Peters
executiveI 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. And I'm pleased to confirm that the proposal to discharge the members of the Board of Directors has been adopted by our shareholders with a 98.07% majority. We will now proceed to agenda Item #3, adoption, updated -- adoption of the updated remuneration policy for the Board of Directors. I would like to ask Steven Baert, the Chair of the Remuneration Committee to present to you the updated remuneration policy for the Board of Directors. Steven?
Steven Baert
executiveThank you Richard. I'm back and I'm pleased to present to you the updated remuneration policy for the Board of Directors. In accordance with Dutch statutory provisions, the remuneration policy for the Board of Directors should be submitted for adoption by the Annual General Meeting at least every 4 years. And since the remuneration policy for the Board of Directors was last adopted by our shareholders December 11 of 2020, we have submitted the updated remuneration policy for adoption by our shareholder during today's meeting. The proposed policy has been updated to ensure continued alignment with market practice, applicable and regulations and expectations from shareholders. And as already explained, under agenda Item 2, we engaged Georgeson as the international strategic consultant for the review of the current Remuneration Policy. And we engaged with proxy advisers to obtain their feedback on the new draft remuneration policy. As part of the meeting documents for today's meeting, you have received a presentation with a summary of the main proposed amendments, including the rationale for the change. And we have also published the full text of the updated Remuneration Policy, clearly reflecting all changes compared to the current policy. As you will have seen, it is proposed to add the following provisions for the remuneration of our CEO. Derogations of the policy shall going forward be permitted in case of exceptional circumstances if necessary to serve the long-term prospects and sustainability of the company. Deviations are also not -- shall also need to be aligned with the main objectives of the Remuneration Policy to ensure a consistent approach. We've added a peer group guiding principle, which provides that Pharming shall align itself with European best practices in the field of remuneration, while remaining competitive in the United States labor market to support the successful execution of its strategy. The latter is important as in 2023, U.S. market accounted for than 97% of sales generated by Pharming. The policy provides that the remuneration of the executive directors is reviewed according to the benchmark of the region, whether as the EU or the U.S. in which they reside. In relation to an increase of the base salary of the Executive Director, the policy is proposed to provide that any increase is required to be substantiated by the outcome of the directors' annual performance review, the company's performance changes in roles and responsibilities, changes in pay and conditions across Pharming and 2-yearly market benchmarks. The policy provides that salary levels are each time determined based on the country of residents of the Executive Director. In relation to the short-term and long-term incentive plans, we've included an extended outline governance process for target setting, including a link of all targets to strategy and measuring. For the short-term incentive plan, we also added a confirmation of retrospective disclosure of all targets and a weighting of financial targets of at least 50%. For all the incentive plans, a detailed vesting schedule for all quantifiable targets has been added, including a threshold and a maximum vesting percentage for each target. The Board of Directors will also undertake to ensure the dilution limits due to the equity plans for staff and the Executive Director are prudently applied. The related grants will not result in exceeding 10% of all issued and outstanding shares of Pharming on a diluted basis. And last but not least, we propose to extend the clawback provisions in the incentive plan in line with the SEC requirements, Dutch law and Dutch Corporate Governance Code. For the nonexecutive directors. The proposed changes can be summarized as follows. As I explained on the agenda Item 2B on the Remuneration Report for the year 2023, we engaged AON Radford, as an international compensation expert for a new market review of the compensation of the members of the Board of Directors, including the fees of the chairs and the members of the committee. Taking the advice from AON Radford into account, we will not propose any changes to the base fee and equity of the nonexecutive directors. For their membership of the Board of Directors as these fees were found to be in line with the European and the U.S. 58th percentile market benchmarks. We did, however, notice that the committee fees have not changed since 2020, and that the frequency of committee meetings and the workload in these meetings has increased significantly as a result of Pharming's growth, its significant presence in the U.S. market and the company's long-term strategy and ambitions. In view thereof, we propose to increase the fees paid to the chairs and members of the respective Board committees as summarized on the screen. The proposed increase will ensure that the fees will be aligned with the European market benchmark for the fees of committee members. The nonexecutive directors have received shares as part of their fixed annual remuneration since 2020, consistent with U.S. market practice and in accordance with the Remuneration Policy for the Board of Directors as adopted by our shareholders on December 11, 2020. To safeguard the independence of the nonexecutive directors, the number of shares awarded has been fixed and the grant has not been linked to the performance of Pharming. To avoid that impression, we proposed to delete the current condition that all shares held by nonexecutive directors will be a long-term investment only. We are aware that this will constitute a deviation from the Corporate Governance Code that we will report in the Annual Report of the year 2024. Last, but not least, I would like to mention that the updated Remuneration Policy, and therefore, all changes are proposed to become effective with retrospective effect from the 1st of January 2024. Dear shareholders, the Dutch Workers' Council (sic) [ Dutch Works Council ] submitted a positive advice regarding the proposed updated Remuneration Policy. The Workers' Councils (sic) [ Works Council's ] advice was also part of the meeting documents for the AGM. I have the pleasure to give the floor now to the Chair of the Works Council. Mrs. Zhen Liu for an explanation of the advice.
Zhen Liu
executiveGood afternoon, [Foreign Language]. Dear Chair, Board of Directors, dear shareholders and the guests. My name is Zhen Liu. I'm the Chair of Pharming's Dutch Works Council. I would like to thank you to begin with the invite to me to this annual meeting. And then indeed, in March, Dutch Works Council received the request of advice from CEO, Sijmen de Vries, about the intended decision of submitting new Remuneration Policy. And the existing regulation policy was adopted by the shareholders in 2020 which is 4 years ago. To meet the requirement of Dutch Civil code, which is listed company to submit their Remuneration Policy, at least once every 4 years. Hence, we fully understand the necessity of submitting a new Remuneration Policy. We also appreciate that the Board of Directors engage leading consultants and aligned with the proxy advisers to ensure the continued alignment with best practice for the new policy. Some of the efforts have been invested the quality and the compliance of the new Remuneration Policy, particularly in line with SEC requirements, Dutch Law and Dutch Corporate Governance code, the clawback provision for incentive plan was included in the new Remuneration Policy. With that, on behalf of all members of Works Council, I'm happy to share that the Works Council advice, based on the Works Council Act Wet op de OndernemingsRaden the Works Council has no objection to the intended decision of adopting the new policy. Thank you.
Richard Peters
executiveThank you, Zhen, and thank you, Steven. I propose that we will now answer the questions that our shareholders may have. I would like to invite our shareholders to ask their questions to Steven on this agenda item. Please go to one of the microphones here in the room and state your name. And if applicable the name of the shareholder you represent before asking your first question. Are there any questions here in the room? I note that there are no questions in the room, and I've just been informed there are no questions online. We, therefore, now proceed with the voting on this agenda item. Our shareholders are proposed to adopt the updated remuneration policy for the Board of Directors with retrospective effect from the 1st of January 2024. This resolution includes the approval of the long term incentive plan for the Executive Director in accordance with the parameters and other conditions set out in the updated remuneration policy within the meaning of the Dutch Civil Code. I kindly remind you that in accordance with the Dutch Law, the adoption of the proposed remuneration policy requires a 75% majority of the votes cast. I will now open the voting and invite our shareholders in this meeting room to cast their votes. [Voting]
Richard Peters
executiveI will now close the voting. The voting result 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 to approve the updated Remuneration Policy for the Board of Directors has been adopted by our shareholders with a 94.17--sorry, 94.17% majority. Under the next agenda item 4, we present the proposals to our shareholders to reappoint Ms. Barbara Yanni and Mr. Mark Pykett. I'm now handing over to Jabine van der Meijs, our Chair of the Corporate Governance Committee, to introduce this agenda item. Jabine?
Jabine van der Meijs
executiveThank you, Richard, and good afternoon to our shareholders. As explained in my explanatory notes, the terms of our Nonexecutive Directors, Barbara Yanni and Mark Pykett are scheduled to expire at the closing of today's general meeting. Both were first appointed to the Board of Directors on the 11th of December 2020. The members of the Board of Directors were appointed in different years. And it implies that all mandates are also scheduled to expire at different moments in time, which is helpful to preserve continuity. . In this context, it is worth mentioning that the mandates of a few members are scheduled to expire during the AGM scheduled next year, so in 2025. This applies to the mandate of Sijmen de Vries as Executive Director/CEO, but also to the mandate of the Deborah Jorn, Leonard Kruimer, Steven Baert and me as Nonexecutive Directors. The Board is, of course, well aware of this and the potential scenarios are under review by us. As soon as we have more information on the reappointment or succession of each Director, we will disclose that. As said, the mandates of Barbara Yanni and Mark Pykett are scheduled to expire at today's general meeting. The agenda includes proposals for the reappointment of Barbara Yanni and Mark Pykett as Nonexecutive Directors each time by way of binding nominations. We are pleased that both Barbara Yanni and Mark Pykett have indicated to be available for reappointment. I will briefly summarize the highlights of the proposals on the agenda in accordance with the outline in the explanatory notes. The Board of Directors have assessed the performance of Barbara and Mark over the past 4 years and reached a positive conclusion. The Board also assessed that Barbara Yanni and Mark Pykett continue to be independent under the Dutch Corporate Governance Code and comply with the maximum number of other outside positions as set by the Dutch Civil Code. An up-to-date overview of their other positions can be found on our website. Therefore, we propose to our shareholders today by way of binding nomination to reappoint Barbara Yanni and Mark Pykett as Nonexecutive Director for a period of 4 years expiring at the closing of the Annual General Meeting to be held in 2028. To enable our company to continue to benefit from their knowledge and experience in the coming years. The Works Council submitted a positive point of view regarding the proposed reappointment of Barbara Yanni and Mark Pykett. The documents summarizing the Works Council point of view are part of the meeting documents for today's meeting. I would like to again invite the Chair of the Works Council, Ms. Zhen Liu, for an explanation of the opinion of the Works Council.
Zhen Liu
executiveBoard of Directors and dear shareholders, guests, my name is Zhen Liu,, Chair of Pharming's Works Council. I'm happy to be here again to share the opinion of Works Council this reappointment of Nonexecutive Directors. In March, the DutchWorks Council received a request for opinion from CEO, Sijmen de Vries, about the intent decision of reappointments, Ms. Yanni and Mr. Pykett as Nonexecutive Directors following the current term. We appreciate that Ms. Yanni and Mr. Pykett's willingness to carry on their significant contribution to the Pharming's Board of Directors and their appointment will surely benefit the continuity of ongoing activities. We also appreciate that the Corporate Governance Committee has evaluated and confirmed that the reappointment comply with the Dutch Corporate Governance Code and the Dutch Civil Code. With that, on behalf of the Works Council members, I'm happy to share the Works Council opinion. Based on the Works Council Act Wet op de OndernemingsRaden we endorsed the intended decision of reappointing Ms. Yanni and Mr. Pykett as Nonexecutive Director for the period of 4 years. Congratulations.
Richard Peters
executiveThank you, Zhen, and thank you, Jabine. I propose that we will now answer the questions that our shareholders may have and would like to invite our shareholders to ask their questions directly to Jabine have been on this agenda. I note that there are no questions here in the room, and I've also been informed that there are no questions online. We will now move on to the voting of the proposals presented under this agenda item each time by binding nomination as explained in the 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 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 that new meeting, the nomination may be rejected with a simple majority of the votes cast. In that event, the Board will draw up in your nomination. I'm now opening the voting on the proposal to reappoint Barbara Yanni by way of binding nomination for a period of 4 years. [Voting]
Richard Peters
executiveI 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. And I'm pleased to confirm that the proposal has been adopted by our shareholders with a 90.23% majority calculations, Barbara? And now opening the voting on the proposal to reappoint Mark Pykett by way of binding nomination for a period of 4 years. So please go ahead and vote for Mark Pykett or against or abstain. [Voting]
Richard Peters
executiveI will now close the voting. The voting results, including the votes received by the means of proxy will be shown on the screen in a few seconds. And I'm pleased to confirm that the proposal has been adopted by our shareholders with a 98.88% majority. Congratulations, Mark. The next item on the agenda is item 5, the proposed authorization of the Board of Directors to issue new shares or rights to acquire shares. 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 and is intended for general 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 also be 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, we replace the existing authorization for general purposes that was granted on May 17, 2023. I'm now inviting our shareholders in this room to go to one of the microphones to ask their questions. I know that there are no questions in the room, and I'm noting also there are no questions online. We will now move on to the voting on the proposal presented under agenda Item 5. This proposal entails the authorization of the Board of Directors to issue shares up to 10% of the issued capital for general purposes [indiscernible] and financing. I'm now opening the voting and invite our shareholders in this meeting room to cast their votes on this proposal, which is described in more detail in the exploratory notes to the agenda. The polls are open. [Voting]
Richard Peters
executiveI will now close the voting. The voting results, including the votes received by the means of proxy will be shown on the screen in a few seconds. And I'm pleased to confirm that the proposal has been adopted by our shareholders with a 93.49% majority. The next item on the agenda is agenda item 6. 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 the details in the explanatory notes to the agenda for today's meeting. The proposed designation will replace the current authorization as granted by the general meeting on May 17, 2023. And I would like to invite our shareholders to ask their questions. Are there any questions on this agenda item here in the room? I know that there are no questions, and I'm also being informed that there are no questions online. So we will 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 vote on the proposed authorization of the Board of Directors to repurchase not more than 10% of the issued capital. This proposal is described in more detail in the explanatory notes to the agenda for today's meeting. The poles are open. [Voting]
Richard Peters
executiveI'm now closing the voting. The voting result including the votes received by the means of proxy will be shown on the screen in a few seconds. And I'm pleased to inform that the proposal has been adopted by our shareholders with a 96.33% majority. The final agenda item 7, any other business. Under this agenda item, we will address the questions that are of a more generic nature. Obviously, to the extent topics are in scope for this meeting. Please go to one of the microphones if you have any questions.
Unknown Attendee
attendeeYes. My name is Keyner. I'm speaking on behalf of VEB. I was wondering whether at the beginning of this year, you had the first press release about results. Revenues were much better than the market expected. And a month later, the final numbers came out. Costs were even much higher than the market was fearing. So profits were down actually it was a loss-making period. Now the market was obviously very disappointing. They're disappointed and surprised. I was wondering were any of the Nonexecutive Directors surprised?
Richard Peters
executiveNo, you cannot grow a company without investing. And especially when you're launching a new drug, the worst thing that we can do is waste time by being penny wise, pound foolish or something like that, they say in English, right? We have to invest.
Unknown Attendee
attendeeI agree fully. Now the point I'm trying to make is something very different. The fact that none of the Nonexecutives were surprised about that was a loss-making year, that the costs were much higher even than we would assume based on the very high revenue, the fact that the market was disappointing -- disappointed? By definition, it means that the expectations were not set correctly in the market. So again, this reconfirms my earlier point that the way you're communicating and setting expectations for the market needs to improve?
Richard Peters
executiveWe appreciate that, and we've heard you loudly a few times today. So thank you very much for emphasizing that. Are there any other questions in the room? I also note there are no questions online. And therefore, I'm now closing this meeting, and thank you all for your attendance today. We look forward to meeting all of you again soon during one of our webinars or one of our many planned corporate events. And I also would like now to invite our shareholders present in the room here in this -- today to join us in the foyer for drinks and some additional conversations. Thank you so much. [Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.]
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