Q3 2025 Pharming Group NV Earnings Call

Speaker #2: Good day and thank you for standing by . Welcome to Pharming Group N.V. third quarter 2025 results conference Call and webcast . At this time , all participants are in a listen only mode .

Speaker #2: After the speakers presentation , there will be a question and answer session . To ask a question during the session , you will need to press star one and one on your telephone .

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Speaker #2: Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Fabrice Chouraqui, Chief Executive Officer.

Speaker #2: Please go ahead .

Speaker #3: Thank you . Operator and good morning and good afternoon , everyone , and welcome to the Pharming's Q3 2025 Earnings Call . I'll be joined on this call today by Steve Thor , our chief commercial officer .

Fabrice Chouraqui: Thank you, operator, and good morning and good afternoon, everyone, and welcome to Pharming's Q3 2025 earnings call. I'll be joined on this call today by Stephen Toor, our Chief Commercial Officer, Anurag Relan, our Chief Medical Officer, and Kenneth Lynard, our new Chief Financial Officer. On this call, we will be making forward-looking statements that are based upon our current insights and plans. As you know, these may well differ from future results. As you saw in our press release earlier today, we delivered another very strong quarter. Total revenues grew by 30% in Q3 2025 versus the same quarter last year, and operating profit jumped to $15.8 million, nearly four times last year's result.

Speaker #3: Anurag Relan . Our chief medical officer . And Kenneth Leonard , our new chief financial officer . On this call , we will be making forward looking statements that are based upon our current insights and plans .

Speaker #3: As you know, these may well differ from future results. As you saw in our press release earlier today, we delivered another very strong quarter.

Speaker #3: Total revenues grew by 30% in the third quarter of 2025 versus the same quarter last year , and operating profit jumped to $15.8 million , nearly four times last year's result .

Speaker #3: Operating cash flow came in at $32 million, putting our cash position almost back to where it was at the end of 2024, before the acquisition of Abiviva.

Fabrice Chouraqui: Operating cash flow came at EUR 32 million, turning our cash position almost back to where it was at the end of 2024 before the acquisition of Abliva. Our strong top-line growth was fueled by the continued significant growth of our two commercial assets, RUCONEST and Joenja. RUCONEST grew 29% year-on-year, fueled by continued strength in new prescribers and in new patient enrollments, even amid the launch of a new oral on-demand therapy in July. This reflects RUCONEST's unique value proposition for severely affected HAE patients, which Steve will elaborate upon in a minute. Joenja Q3 revenue increased by 35%, reflecting the 25% year-on-year growth in patient on treatment and our increasing success in finding new APDS patients. The drug continues its uptake in the 12 year-plus APDS segments.

Speaker #3: Our strong top line growth was fueled by the continued significant growth of our two commercial assets , Ruconest and Joenja . Ruconest grew 29% year on year , fueled by continued strength in New prescribers and in new patient enrollments .

Speaker #3: Even amid the launch of a new oral on-demand therapy in July, this reflects Ruconest's unique value proposition for severely affected patients, which Steve will elaborate upon in a minute.

Speaker #3: Join us . Quarter revenue increased by 35% . Reflecting the 25% year on year growth in patient on treatment and our increasing success in finding new patients .

Speaker #3: The drug continues its uptake in the 12 year plus ipds segments , and when looking ahead , we anticipate adding new sources of growth with the pediatric indication , the reclassification of US patients and our geographic expansion .

Fabrice Chouraqui: When looking ahead, we anticipate adding new sources of growth with the pediatric indication, the reclassification of the US patients, and our geographic expansion. This true momentum for our 2 commercial assets support an upgrade to our full year 2025 revenue guidance to EUR 360 to 365, 375 million from the previous EUR 335 to 350 million, for which Kenneth will provide more details later in the call. Finally, the recently announced significant reduction in G&A headcounts follows through on our plan to optimize capital deployment to high growth initiatives to fully capitalize on our significant growth prospects. Before we review our commercial and financial results in great detail, I'd like to highlight that our Q3 performance reflect our strong growth foundation.

Speaker #3: The strong momentum for our two commercial assets supports an upgrade to our full year 2025 revenue guidance to $360 to $375 million, from the previous $335 to $350 million, for which Kenneth will provide more details later in the call.

Speaker #3: Finally , the recently announced significant reduction in G&A accounts follows through on our plan to optimize capital deployment to high growth initiatives to fully capitalize on our significant growth prospects .

Speaker #3: Before we review our commercial and financial results in greater detail . I'd like to highlight that our Q3 performance reflects our strong growth foundation in just a few years , farming has transformed from a single asset company into a fast growing biotech with two high growth commercial products and a late stage pipeline with two programs .

Fabrice Chouraqui: In just a few years, Pharming has transformed from a single asset company into a fast-growing biotech with two high-growth commercial products and a late-stage pipeline with two programs with over EUR 1 billion sales potential each. As we've seen, RUCONEST continues to grow double digits after 10 years on the market. Its unique value for severe HAE patients and specific manufacturing process make it a reliable cash engine to fund our future growth. Joenja is just at the beginning of its life cycle with multiple growth catalysts. The recent data published in Cell suggests significantly higher APDS prevalence, and the expansion in larger PIDs and CVID could unlock a much larger market. KL1333 for primary mitochondrial disease is another EUR 1 billion-plus opportunity with a positive QTD analysis in the ongoing registrational study.

Speaker #3: With over $1 billion sales potential , age . As we've seen recognized , continues to grow double digit after ten years on the market .

Speaker #3: Its unique value for severe high patients and specific manufacturing process make it a reliable cash engine to fund our future growth . Georgia is just at the beginning of its life with multiple growth catalysts .

Speaker #3: The recent data , published in sales suggests significantly higher prevalence and the expansion in larger pidds and Cvid could unlock a much larger market .

Speaker #3: HCL One Three for primary mitochondrial disease is another billion-dollar-plus opportunity, with a positive futility analysis in the ongoing registrational study.

Speaker #3: So this combination of durable revenues , first indices , innovation and late stage pipeline positions , farming well for substantial value creation in the near and long term .

Fabrice Chouraqui: This combination of durable revenues, first-in-disease innovation, and late-stage pipeline positions Pharming well for substantial value creation in the near and long term. With this portfolio and pipeline as the foundation, we can leverage our strong rare disease capabilities to build a leading global rare disease company and deliver on our vision. I'll now hand over to Steve, who will discuss our commercial progress during the quarter and elaborate on the continued strong growth of RUCONEST and Joenja.

Speaker #3: With this portfolio and pipeline as the foundation , we can leverage our strong rare disease capabilities to build a leading global rare disease company and deliver on our vision .

Speaker #3: I'll now hand over to Steve , who will discuss our commercial progress during the quarter and elaborate on the continued strong growth of Ruconest and Ginger .

Speaker #4: Thank you . Fabrice . Good morning everybody . As Fabrice said , Ruconest has delivered another very successful quarter with high double digit growth of $82 million in revenue , which is up 29% on Q3 of last year .

Stephen Toor: Thank you, Fabrice. Good morning, everybody. As Fabrice said, RUCONEST has delivered another very successful quarter with high double-digit growth of $82 million in revenue, which is up 29% on Q3 of last year. The strong growth is being driven by the continued increase in prescribers quarter on quarter. New prescribers are recognizing the value RUCONEST brings to patients suffering with moderate to severe HAE, and this underpins our consistent prescriber growth over the years. In fact, we've added an average of 22 new prescribers in the past 6 quarters, which leads directly to the high level of new patient enrollments and the vial volume increase over prior year, which is at 28% versus the first 9 months of 2024.

Speaker #4: The strong growth is being driven by the continued increase in prescribers quarter on quarter . New prescribers are recognizing the value Ruconest brings to patients suffering with moderate to severe high , and this underpins our consistent prescriber growth over the years .

Speaker #4: In fact , we've added an average of 22 new prescribers in the past six quarters , which leads directly to the high level of new patient enrollments and the vital volume increase over prior year , which is at 28% versus the first nine months of 2024 .

Speaker #4: Farming sustained success unabated by the recent launch of the oral product reflects Ruconest unique profile and strong differentiation in the acute on demand Ha market .

Stephen Toor: Pharming sustained success unabated by the recent launch of the oral product reflects Ruconest's unique profile and strong differentiation in the acute on-demand HAE market. Ruconest remains an important treatment option for moderate to severe patients who experience more frequent attacks, which explains the continued strong momentum and our confidence in the product's long-term growth prospects. As a reminder, Ruconest is a highly effective product serving all patient types: type 1, type 2, and normal C1. Specifically, those patients suffering from frequent moderate to severe debilitating HAE attacks. They've also typically failed other single pathway-specific targeted acute therapies such as eCataPAM, which have not been effective for them, often leading to the need to redose to stop their HAE attack. As the only recombinant C1 protein replacement therapy, Ruconest uniquely addresses the root cause of HAE, providing strong differentiation versus single pathway targeted therapies.

Speaker #4: Ruconest remains an important treatment option for moderate to severe patients who experience more frequent attacks , which explains the continued strong momentum and our confidence in the product's long term growth prospects .

Speaker #4: As a reminder , Ruconest is a highly effective product , serving all patient types . Type one . Type two , and normal C1 , specifically , those patients suffering from frequent , moderate to severe debilitating Ha attacks .

Speaker #4: They've also typically failed other single pathway specific targeted acute therapies , such as a icatibant , which have not been effective for them .

Speaker #4: Often leading to the need to re dose to stop their Ha attack . As the only recombinant C1 protein replacement therapy , ruconest uniquely addresses the root cause of Ha , providing strong differentiation versus single pathway targeted therapies .

Speaker #4: This differentiation is why Ruconest is a cornerstone treatment for Hae attacks . You can see in the photographs on this slide an actual ruconest patient .

Stephen Toor: This differentiation is why RUCONEST is a cornerstone treatment for HAE attacks. You can see in the photographs on this slide an actual RUCONEST patient, and this is exactly the type of patient I mean, with a more severe course of disease, attacking frequently and having to redose on other therapies, along with her recovery as she resolves the attack. HAE patients with the disease profile I've described need RUCONEST on hand, which through its IV mode of action, delivers a bolus of C1 straight in the vein, which is critical for them. As a result, by using RUCONEST, patients get complete resolution in a single dose for 97% of their attacks. Half of those patients actually get complete attack resolution in 4.5 hours, with the vast majority within 24.

Speaker #4: And this is exactly the type of patient I mean , with a more severe course of disease attacking frequently and having to re dose another therapies along with her recovery as she resolves the attack .

Speaker #4: Ha patients with the disease profile I've described need ruconest on hand , which through its IV mode of action delivers a bolus of C1 straight in the vein , which is critical for them as a result , by using Ruconest , patients get complete resolution in a single dose for 97% of their attacks .

Speaker #4: Half of those patients actually get complete attack resolution in 4.5 hours , with the vast majority within 24 . That efficacy is both critical and reassuring , and that is direct feedback from the patients we serve .

Stephen Toor: That efficacy is both critical and reassuring, and that is direct feedback from the patients we serve. Switching gears to Joenja, as with RUCONEST, we've delivered another strong third quarter. We achieved high double-digit year-over-year revenue growth of plus 35%, generating $15.1 million in revenue for the quarter. The number of US patients on paid therapy is up 25% versus Q3 2024. Importantly, we've identified 13 additional APDS patients in Q3 alone, which shows our ability to keep building the patient funnel in this ultra-rare disease. We're finding patients faster than we did in 2024, with a total number of APDS patients in the US now at 270. Importantly, the resulting significant increase in patients versus 2024 on patients' consistently high adherence to therapy is driving this strong revenue growth.

Speaker #4: Switching gears to Joenja , as with Ruconest , we've delivered another strong third quarter . We achieved high double digit year over year revenue growth of 35% , generating $15.1 million in revenue for the quarter .

Speaker #4: The number of US patients on paid therapy is up 25% versus Q3 2024 , and importantly , we've identified 13 additional APDs patients in Q3 alone , which shows our ability to keep building the patient funnel in this ultra rare disease .

Speaker #4: We're finding patients faster than we did in 2024 , with a total number of APDs patients in the US now at 270 . Importantly , the resulting significant increase in patients versus 2024 on patients consistently high adherence to therapy is driving this strong revenue growth .

Speaker #4: The launch of Ginger in the UK is also going well , and this is an important first step as we execute our focused geographic expansion plans .

Stephen Toor: The launch of Joenja in the UK is also going well, and this is an important first step as we execute our focused geographic expansion plans. Let's now, though, review the next significant inflection point, which is the pediatric launch in the US for patients aged 4 to 11. The FDA has granted priority review of our application to expand the label and assigned a PDUFA date or an approval date of 31 January 2026. Our preparations for launch after the expected approval in January are on track. As we approach the US pediatric launch, the team has already identified 54 patients diagnosed with APDS age 4 to 11. One third of those patients are already on therapy through Pharming's early access program, and with many others likely to go on therapy soon after launch.

Speaker #4: Let's now review the next significant inflection point , which is the pediatric launch in the US for patients aged 4 to 11 . The FDA , the FDA has granted priority review of our application to expand the label and assigned a due date or an approval date of January 31st , 2026 .

Speaker #4: Our preparations for launch after the expected approval in January are on track as we approach the US pediatric launch . The team has already identified 54 patients diagnosed with APDs aged 4 to 11 , one third of those patients are already on therapy through Pharming's Early Access program , and with many others likely to go on therapy soon after launch .

Speaker #4: So this represents an important growth driver for Pharming , which starts in just a few months . I'd like to now hand over to .

Stephen Toor: This represents an important growth driver for Pharming, which starts in just a few months. I'd like to now hand over to Anurag, who'll discuss our development programs and the forthcoming data presentations at the American College of Allergy, Asthma and Immunology later this week in Orlando.

Speaker #4: Who will discuss our development programs and the forthcoming data presentations at the American College of Allergy , Asthma and Immunology later this week in Orlando .

Speaker #5: Thanks , Steve . In addition to the commercial successes in the quarter , we continued to advance our pipeline in the past three months in APDs .

Anurag Relan: Thanks, Steve. In addition to the commercial successes in the quarter, we continued to advance our pipeline in the past 3 months. In APDS, as you mentioned, Steve, the FDA granted priority review for our sNDA for 4 to 11-year-old children, underscoring the seriousness of the disease and the potential to offer a new treatment option with leniolisib. We also have regulatory filings under review in Europe, Japan, and Canada, with approvals anticipated in 2026. We have two phase II proof of concept studies for PIDs with immune dysregulation, these are also on track for readouts in the second half of 2026. Our newest addition to the pipeline is also progressing nicely. KL1333 in a registrational study for primary mitochondrial disease, where enrollment and site activation are advancing, and we continue to expect a readout in late 2027.

Speaker #5: As you mentioned , Steve , the FDA granted priority review for our Snda for 4 to 11 year old children , underscoring the seriousness of the disease and the potential to offer a new treatment option with Leniolisib .

Speaker #5: We also have regulatory filings under review in Europe , Japan and Canada with approvals anticipated in 2026 . We have two phase two proof of concept studies for Pidds with immune dysregulation , and these are also on track for readouts in the second half of 26 .

Speaker #5: And then our newest addition to the pipeline is also progressing nicely . CLL one and three in a registrational study for primary mitochondrial disease , where enrollment and site activation are advancing and we continue to expect to readout in late 2027 .

Speaker #5: As a recall , there was an important publication in cell in June . This work has implications for the variants of uncertain significance , or VUS reclassification work , which is ongoing by the labs .

Anurag Relan: As you recall, there was an important publication in Cell in June. This work has implications for the variance of uncertain significance or VUS reclassification work, which is ongoing by the labs. The publication in Cell, however, also opens another potential avenue to expand the APDS population. Specifically, the paper found more than 100 new gain-of-function PI3K delta variants. What surprised the researchers was that these gain-of-function variants were much more commonly found in population databases, suggesting an APDS prevalence up to 100 times higher than current estimates, as well as a broader set of clinical symptoms. This raises a number of key questions to determine how these variants may cause disease, including which variants cause clinically meaningful gain-of-function? What symptoms and diseases do these variants cause, and how do we find patients with these variants?

Speaker #5: The publication in cell , however , also opens another potential avenue to expand the APDs population , specifically , the paper found more than 100 new gain of function Pi3-k delta variants .

Speaker #5: With surprise . The researchers was that these gain of function variants were much more commonly found in population databases , suggesting an APDs prevalence up to 100 times higher than current estimates , as well as a broader set of clinical symptoms .

Speaker #5: This raises a number of key questions to determine how these variants may cause disease , including which variants cause clinically meaningful gain of function , what symptoms , and diseases do these variants cause , and how do we find patients with these variants ?

Speaker #5: We started a number of activities now to help answer these questions . First , we're convening a global Kol ad board this month to address how these variants can cause disease .

Anurag Relan: We started a number of activities now to help answer these questions. First, we're convening a global KOL at Ad Board this month to address how these variants can cause disease. In parallel, we're sponsoring work to build a predictive AI-driven model that could identify patients who could benefit from targeted PI3K delta inhibition with a goal to best then to be able to apply the model to large EMR databases. Given the significant findings, we can actually identify more gain-of-function variants with newer base editing technologies. Generating additional variants will be important not only to understand the broader prevalence, but also for the ongoing VUS resolution project. Much more to come on this exciting work. We also have new data being presented at the American College of Allergy, Asthma, and Immunology.

Speaker #5: In parallel , we're sponsoring work to build a predictive AI driven model that could identify patients who could benefit from targeted pi3-k delta inhibition , with the goal to then to be able to apply the model to large EMR databases .

Speaker #5: And given the significant findings , we can actually identify more gain of function variants with newer base editing technologies , generating additional variants will be important not only to understand the broader prevalence , but also for the ongoing US resolution project .

Speaker #5: So much more to come on this exciting work . We also have new data being presented at the American College of Allergy , Asthma and Immunology .

Speaker #5: There are five posters on Ruconest where we performed a re-analysis of our clinical trial data with recently used definitions of key endpoints . These data highlight the key symptom benefits in high patients experience with Ruconest across a number of clinically relevant outcomes .

Anurag Relan: There are five posters on RUCONEST, where we performed a reanalysis of our clinical trial data with recently used definitions of key endpoints. These data highlight the key symptom benefits in HAE patients experience with RUCONEST across a number of clinically relevant outcomes. In addition, an indirect treatment comparison with Cevotrazumab will be presented, providing additional evidence for the unique benefits that RUCONEST offers HAE patients. On the APDS side, we have poster describing the treatment burden of the disease on both patients and caregivers. We also have a number of posters on Joenja with real-world data highlighting key benefits, including a reduction in infections. Lastly, ahead of our expected pediatric approval, we have new data in this 4 to 11-year-old APDS population showing important outcomes, especially on quality of life improvements seen in the study.

Speaker #5: In addition , an indirect treatment comparison with Sebetralstat will be presented , providing additional evidence for the unique benefits that Ruconest offers , high patients on the APDs side , we have posters describing the treatment burden of the disease on both patients and caregivers .

Speaker #5: We also have a number of posters on joenja with real world data highlighting key benefits , including a reduction in infections . Lastly , ahead of our expected pediatric approval , we have new data in this 4 to 11 year old APDs population showing important outcomes , especially on quality of life improvements seen in this study .

Speaker #5: I'll turn it over now to Kenneth , our newest member of the team , to review our financials .

Anurag Relan: I'll turn it over now to Kenneth, our newest member of the team, to review our financials.

Speaker #6: Thank you . Anurag , as the new CFO , I'm excited to have joined farming at such an exciting time and have the opportunity to provide more color on our strong financial performance and outlook .

Kenneth Lynard: Thank you, Anurag. As the new CFO, I'm excited to have joined Pharming at such an exciting time and have the opportunity to provide more color on our strong financial performance and outlook. Q3 was an excellent quarter with revenues at EUR 97.3 million, up 30% versus the same quarter last year. We saw double-digit revenue growth for both RUCONEST and Joenja. Gross profit grew by 33% to EUR 90.2 million, mainly due to the higher revenues, and accordingly, we recorded a gross margin of 93% versus 91% same quarter in 2024. Our operating profit with a slight adjustment, as it's noted here on the slide, almost increased to 4x to EUR 16.0 million compared to EUR 4.1 last year. That came from growth in revenues, the improved gross margin, and well-managed operating costs.

Speaker #6: Q3 was an excellent quarter with revenues at 97.3 million , up 30% versus the same quarter last year . We saw double digit revenue growth for both Ruconest and younger gross profit grew by 33% to 90.2 million , mainly due to the higher revenues and accordingly , we recorded a gross margin of 93% versus 91% same quarter in 2020 .

Speaker #6: For our operating profit , with a slight adjustment . As it's noted here on the slide , almost increased to four x to 16.0 million compared to 4.1 last year .

Speaker #6: That came from growth in revenues. The improved gross margin and well-managed operating costs resulted in cash and marketable securities increasing from $130.8 million at the end of Q2 to $168.9 million at the end of Q3.

Kenneth Lynard: Cash and marketable securities increased from EUR 130.8 million at the end of Q2 to EUR 168.9 million at the end of Q3. This increase was driven by significant cash flow from operating activities with EUR 32 million. As Fabrice Chouraqui mentioned, the total balance of cash and marketable securities is now back in line with the end of 2024 prior to the Abliva acquisition. Our year-to-date consolidated financial numbers for the first nine months show continued strong execution of our strategy. Total revenues grew by 32% to EUR 269.6 million, due to strong double-digit revenue growth for both products, and gross profit grew by 35%.

Speaker #6: This increase was driven by significant cash flow from operating activities , with 32 million . And a mentioned the total balance of cash and marketable securities is now back in line with the end of 2024 .

Speaker #6: Prior to the acquisition, our year-to-date consolidated financial numbers for the first nine months show continued strong execution of our strategy.

Speaker #6: Total revenues grew by 32% to $269.6 million due to strong double-digit revenue growth for both products, and gross profit grew by 35%.

Speaker #6: Operating expenses increased by $29.2 million, excluding $20.4 million of related acquisition expenses, and our operating expenses were up by only 4%.

Kenneth Lynard: Operating expenses increased by EUR 29.2 million, excluding EUR 20.4 million of Abliva-related acquisition expenses, and our operating expenses were up by only 4%. Adjusted operating profit, excluding non-recurring Abliva acquisition-related expenses, well, was EUR 29.7 million, which compared to a loss of EUR 15.3 million for the first 9 months of 2024. Cash flow from operating activities was EUR 44 million in the first 9 months of the year. Following the strong results for the first 9 months, we're raising our 2025 total revenue guidance to EUR 365 to 375 million, up from EUR 335 to 350 million. This implies full-year revenue growth between 23% to 26%. The increase is due to continued strong performance and outlook for the remainder of the year.

Speaker #6: Adjusted operating profit, excluding non-recurring acquisition-related expenses, was up compared to $29.7 million, which is an improvement from a loss of $15.3 million for the first nine months of 2020.

Speaker #6: For cash flow from operating activities , was 44 million . In the first nine months of the year . Following the strong results for the first nine months , we are raising our 2025 total revenue guidance to 365 to 375 million , up from 335 to 350 million .

Speaker #6: This implies full year revenue growth between 23 to 26% . The increase is due to continued strong performance and outlook for the remainder of the year .

Speaker #6: We continue to expect total operating expenses between 304 to 308 million . This assumes constant foreign exchange rates for the remainder of the year , includes 10.2 million of non-recurring ab-liva acquisition related transaction expenses , and excludes approximately 7,000,000 in 1 time restructuring costs related to the implementation of our G&A reduction plan .

Kenneth Lynard: We continue to expect total operating expenses between EUR 304 to 308 million. This assumes constant foreign exchange rate for the remainder of the year, includes EUR 10.2 million of non-recurring Epleeva acquisition-related transaction expenses, and excludes approximately EUR 7 million in one-time restructuring costs related to the implementation of our G&A reduction plan. We continue to expect that our available cash and future cash flows will cover the current pipeline and related pre-launch costs. Going forward, we'll further accelerate setting a foundation for strong financial discipline with investments into areas that matters the most to spark near and long-term value creation. On a personal note, I came to Pharming given my deep belief in its mission to bring life-changing therapies to rare disease patients and for the strong potential to develop a leading global rare disease company.

Speaker #6: We continue to expect that our available cash and future cash flows will cover the current pipeline and related prelaunch cost going forward . We'll further accelerate setting the foundation for strong financial discipline with investments into areas that matters the most to spark near and long term value creation on a personal note , I came to farming , giving my deep belief in its mission to bring life changing therapies to rare disease patients and for the strong potential to develop a leading global rare disease company .

Speaker #6: I see great opportunity to sharpen our focus on profitable growth effectively allocate capital to maximize return on investment , and improve transparency and predictability in our financial reporting .

Kenneth Lynard: I see great opportunity to sharpen our focus on profitable growth, effectively allocate capital to maximize return on investments, and improve transparency and predictability in our financial reporting. With that, let me hand back now to Fabrice for closing remarks.

Speaker #6: With that, let me hand back now to Fabrice for closing remarks.

Speaker #3: Thank you . Kenneth . So in summary , we are really pleased to report , yet another strong quarter reinforcing the strength of our business for sustainable growth and long term value creation .

Fabrice Chouraqui: Thank you, Kenneth. In summary, we are really pleased to report yet another strong quarter, reinforcing the strength of our business for sustainable growth and long-term value creation. As you heard from Kenneth, as a result of this performance and our outlook for the remaining of the year, we are raising again our full-year guidance. Looking ahead, RUCONEST is poised to continue to grow and to remain a cornerstone treatment for severe HAE patients, underpinning a strong revenue base. Joenja is well-positioned to generate a significant portion of our revenues in the future, given its strong growth and the additional opportunities we are actively unlocking. Our high-value pipeline is advancing rapidly with a clear objective to deliver two potential blockbuster assets, creating meaningful value creation catalyst for shareholders.

Speaker #3: As you heard from Kenneth, as a result of this performance and our outlook for the remainder of the year, we are raising again our full-year guidance.

Speaker #3: Looking ahead , Ruconest is poised to continue to grow and to remain a cornerstone treatment for severe Ha patients , underpinning a strong revenue base .

Speaker #3: Jahangir is well positioned to generate a significant portion of our revenues in the future , given its strong growth and the additional opportunities we are actively unlocking our high value pipeline is advancing rapidly with a clear objective to deliver two potential blockbuster assets , creating meaningful value creation catalysts for shareholders .

Speaker #3: And we are also taking decisive steps to enhance financial discipline, including optimizing headcount to ensure efficient capital allocation and maximizing our return.

Fabrice Chouraqui: We are also taking decisive steps to enhance financial discipline, including optimizing G&A outcomes to ensure efficient capital allocation and maximizing our return. I'd like to end this call by expressing my sincere gratitude to Stephen Toor for his contributions to Pharming over the past nine years. We look forward to his continued support as an advisor to the company, and we are very excited to welcome Leverne Marsh as our new Chief Commercial Officer to drive the next phase of commercial growth. Let me now open the line for questions.

Speaker #3: I would like to end this call by expressing my sincere gratitude to Steve Thor for his contribution to farming over the past nine years.

Speaker #3: We look forward to his continued support as an advisor to the company, and we are very excited to welcome Le'Veon March as our new Chief Commercial Officer to drive the next phase of commercial growth.

Speaker #3: Let me now open the line for questions .

Speaker #2: Thank you . As a reminder to ask a question , please press star one and one on your telephone and wait for your name to be announced .

Operator: Thank you. As a reminder, to ask a question, please press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. Please stand by as we compile the Q&A roster. First question comes from Jeff Jones of Oppenheimer. Please go ahead.

Speaker #2: To withdraw your question, please press star one and one again. Please stand by as we compile the Q&A roster. The first question comes from Jeff Jones of Oppenheimer.

Speaker #2: Please go ahead .

Speaker #7: Good morning guys , and thanks for taking the question . And congrats on a really strong quarter . Two questions from us . With respect to .

Jeff Jones: Good morning, guys, or afternoon, and thanks for taking the question, and congrats on a really strong quarter. Two questions from us. With respect to RUCONEST, can you speak to any impact you're seeing from the new world that is coming onto the market? Where do you see it being adopted, and do you anticipate any pressure on your patient base? For Joenja, you mentioned that one-third of the pediatric patients already identified are currently on therapy through early access. Any impact on revenue from these patients when the product is formally approved next year? Thank you.

Speaker #7: Ruconest. Can you speak to any impact you're seeing from the new oral treatment that has come onto the market? Where do you see it being adopted?

Speaker #7: And any do you anticipate any pressure on your patient base ? And then for Joneja , you mentioned that one third of the pediatric patients already identified are currently on therapy through early access .

Speaker #7: Any impact on revenue from these patients when the product is formally approved next year? Thank you.

Fabrice Chouraqui: Thank you so much, Jeff, for your question. On RUCONEST, I mean, clearly we don't see RUCONEST competing head-to-head with sebetralstat. That's why I cannot comment, you know, on how sebetralstat is doing. As I mentioned, I believe we have a highly distinctive value proposition that serves a different type of patients, more severe patients. This is due to a unique mode of action that replace the missing, the deficient protein underlying the biology of the disease, and a very specific mode of administration. As such, I believe that many more patients could benefit from RUCONEST. Many more patients who are not yet well controlled on an on-demand treatment. That's the vast majority of the RUCONEST patients.

Speaker #3: Thank you so much for your question . So on Ruconest . I mean , clearly we don't see Ruconest competing head to head with with Sebetralstat .

Speaker #3: And so that's why I cannot comment on on how . Service trust is doing . As I mentioned , I believe we have a highly distinctive value proposition that serves a different type of of patients .

Speaker #3: More severe patients . And this is due to a unique mode of action that replace the missing the deficient protein underlying the biology of the disease .

Speaker #3: And a very specific mode of administration . As such , I believe that many more patients could benefit from ruconest many more patients who are not yet well controlled on an on demand treatment .

Speaker #3: And that's the vast majority of the Ruconest patients. These are patients who have not been able to be controlled appropriately with other treatments and ultimately got the efficacy that they needed with a treatment with Ruconest.

Fabrice Chouraqui: These are patients who have not been able to be controlled appropriately with other treatments, and ultimately got the efficacy that they needed with a treatment, with RUCONEST. When it comes to the pediatric, the question on Joenja and pediatric, as you rightly said, we have identified already 54 pediatric patients in the US, and about one-third of them are on our early access program. We expect to convert these patients, those patients who are already on the drug, fairly quickly. As such, which is typically what you see in rare disease, in ultra-rare disease, we expect somehow a bonus of patients to come on drug. This will then add to the patients that are already identified, that we will strive hard to ensure that they can benefit from RUCONEST.

Speaker #3: When it comes to the the pediatric , the question on joint and pediatric , as you rightly said , we have identified already 54 pediatric patients in the US and about one third of them are on our early access program .

Speaker #3: We expect to convert this this patients , those patients who are already under drug fairly quickly and as such , which is typically what you see in in rare disease , in ultra rare disease , we expect somehow a bolus of patient to common drug .

Speaker #3: This will this will then add to the patient that are already identified that we will strive hard to ensure that they can benefit from ruconest .

Speaker #3: And then we'll come . Additional patients , pediatric patients that we are committed to identifying . So the normal sequence where you have first patients who are on access program , that will convert , second , patients who are already identified .

Fabrice Chouraqui: Then will come additional patients, pediatric patients, that we are committed to identifying. The normal sequence where you have first patients who are on access program that will convert. Second, patients who are already identified that will probably come on drug if their doctors decide so. Then new patients that you identify. Really, that sequence will probably happen next year. Given the number of patients that we have already identified, 54, it's a large number. We believe that pediatric, the expansion of the pediatric label to the pediatric population will be a significant growth driver that we add to the current source of business in adults in the 12-year plus segment.

Speaker #3: That will probably come on drug if their doctors decide . So . And then new patients that you identify . So really that sequence will probably happen next year .

Speaker #3: And given the number of patients that we have already identified , 54 , it's a large number . We believe that pediatric , the expansion of the pediatric , the label to the pediatric population will be a significant growth driver that will add to the current source of business in adults in the 12 year plus segment .

Speaker #7: Thank you very much for answering the questions .

Jeff Jones: Thank you very much for answering the questions, Fabrice.

Speaker #3: Thank you .

Fabrice Chouraqui: Thank you.

Speaker #2: Thank you . Just a moment for our next question . Please . Next we have Lucy quarantine from Jefferies . Please go ahead .

Operator: Thank you. Just a moment for our next question, please. Next we have Lucy Codrington from Jefferies. Please go ahead.

Speaker #8: Hi there . Thank you for taking my questions . I've got a few , if I may . So just following , then on Ruconest and apologies if I missed this at the beginning of the call .

Lucy Codrington: Hi there. Thank you for taking my questions. I've got a few, if I may. Just following then on RUCONEST, and apologies if I missed this at the beginning of the call. I was late joining. The plan to stop RUCONEST outside of the US, have you given a timeframe on when that will become effective? Just in terms of the competitive threat from Acturly, given I totally understand your the different positionings of the drugs, but how often are typically HAE patients seen by their specialist for then any, if there were to be any switching for that to potentially become apparent? Moving on to Joenja.

Speaker #8: I was late joining the plan to stop Ruconest outside of the U.S. Have you given a time frame on when that will become effective?

Speaker #8: And then , just in terms of the competitive threat from Italy , given totally understanding your the different positionings of the drugs , but how often are typically ha patients seen by their specialist for then any if there were to be any switching for that to potentially become apparent .

Speaker #8: And then moving on to Joenja in terms of the the US opportunity , are you happy with the rate at which the this I mean , my understanding is we might start to see Voss patients in the second half .

Lucy Codrington: In terms of the US opportunity, are you happy with the rate at which this I mean, my understanding was we might start to see the US patients in H2. I noticed that the guide no longer, the kind of details with your outlook no longer kind of suggest that. Is that something that you think is now more likely to be pushed into 2026? What is the process for VUSs outside of the US? Then, if I may, two more. Just in terms of the compliance rates on Joenja, I think before it's been roughly around 85%. Is that something you're still happy with?

Speaker #8: And I noticed that the guide no longer has the kind of details regarding your outlook; it no longer suggests that. So is that something that you think is now more likely to be pushed into 2026?

Speaker #8: And what is the process for the US outside of the US ? And then , if I may , two more , just in terms of the compliance rates on Joenja , I think before it's been roughly around 85% .

Speaker #8: Is that something you're still happy with ? And then just in general , your rate of progress identifying patients . What do you think the anticipated peak could be within the US ?

Lucy Codrington: Then just in general, your rate of progress identifying patients, what do you think the anticipated peak could be within the US? Thank you. Sorry for so many.

Speaker #8: Thank you . Sorry for so many .

Speaker #3: Thank you Lucy . I'll try to cover all all your questions . So I'll start with with Ruconest and your questions related to the the listing of recognized in some countries in in Europe , we plan to complete this by by the first half , first quarter , end of the first quarter , first half of next year .

Fabrice Chouraqui: Thank you, Lucy Codrington. I'll try to cover all your questions. I'll start with RUCONEST and your questions related to the delisting of RUCONEST in some countries in Europe. We plan to complete this by H1 of next year. And again, this is really driven by the fact that we don't see the commercialization of RUCONEST in this country that's financially sustainable. Given the number of growth drivers that we have, we hope to be financially disciplined. Ensure that we deploy our capital appropriately.

Speaker #3: When it comes to and again , this is really driven by the fact that we don't see the commercialization of ruconest in these countries as financially sustainable , given the number of growth drivers that we have , we hope to be financially disciplined and ensure that we we deploy our capital appropriately .

Speaker #3: Obviously , we are working with all stakeholders in those countries to ensure that those patients will be able to access the right treatments and if needed , ensure continuity of supply of Ruconest through compassionate use , access mechanism .

Fabrice Chouraqui: Obviously, we are working with all stakeholders in those countries to ensure that those patients will be able to access the right treatments and, if needed, ensure continuity of supply of RUCONEST through compassionate use access mechanism. When it comes to Acturly, I mean, I said that clearly, for me, the RUCONEST and Acturly are serving two different types of patients. As such, I don't see a significant threat for RUCONEST. I mean, RUCONEST is a drug that has a unique mode of action that replace the missing of deficient protein underlying the biology of the disease. RUCONEST has a very unique mode of administration that allow a very fast onset of action. As such, it has a unique, valuable position for more difficult to treat patients.

Speaker #3: When it comes to to actually , I mean , I said that clearly the for me , the ruconest and actually are serving two different types of of of patients and as such I , I don't see a significant threat for , for recognized .

Speaker #3: I mean , ruconest is a drug that has a unique mode of action that replace the missing or deficient protein underlying the biology of the disease .

Speaker #3: Recognized has a very unique mode of administration that allows a very fast onset of action , and as such , it has a unique value proposition for more difficult to treat patients .

Speaker #3: And that's why the vast majority of patients on Ruconest are more severe. Patients who often have failed other treatments, or patients who actually need that level of efficacy.

Fabrice Chouraqui: That's why the vast majority of patients on RUCONEST are more severe patients, are patients that often have failed other treatments, are patient that needs actually that level of efficacy, that speed of onset to really address their more frequent and more severe crisis. Moving to Joenja and your question about the US. As Anurag said, test labs are in ongoing conversations with the researchers which published this paper in Cell. We expect that over time, about 20% of the US patients to be reclassified as APDS. We have obviously to remain arm length, obviously, to what's happening, and hope that the discussion will progress well, and that we will see some patients being reclassified. Outside the US, the process will be the same.

Speaker #3: That's speed of onset to really address their more frequent and more severe crisis . Moving to join . And your question about views as Anurag said are labs are in ongoing conversations with the researchers , which published this paper in Cell .

Speaker #3: And we expect that over time , about 20% of the US patients to be reclassified as as a PBS , we have obviously , to to remain arm's length .

Speaker #3: Obviously to to what's happening and hope that the discussion will , will will progress well and that we will see some patients being reclassified outside the US .

Speaker #3: The process will be the same . Test labs will have to again understand the data , incorporate the data , identify patients who are carriers of those newly identified variants , and if those if those test labs feel that those patients needs to be reclassified , then they'll call the doctors .

Fabrice Chouraqui: Test labs will have to again understand the data, incorporate the data, identify patients who are carriers of those newly identified variants. If those test labs feel that those patients needs to be reclassified, they'll call the doctors, and the doctors will probably reach out to the patients. The adherence rate is, we don't see any change actually in the adherence rate for Joenja. It is actually remains extremely strong and around the magnitude that you have mentioned. When it comes to patient identification, you're right that we're very pleased to see that our efforts continue to pay off and that we have added 13 new APDS patients. In Q3, we have identified 13 new APDS patients in the US in Q3.

Speaker #3: And then the doctors will probably reach out to the patients . The adherence rate is we don't see any change , actually , in the adherence rate for for JNJ , it is actually remains extremely strong .

Speaker #3: And around the magnitude that that you have mentioned . When it comes to patient identification , you're right that we're very pleased to see that our efforts continue to pay off and that we have added 13 new APDs patients in Q3 .

Speaker #3: We have identified 13 new IPD Ipds patients in the US in Q3 . That shows our capability to identify patients in this ultra rare suffering from these ultra rare disease .

Fabrice Chouraqui: That shows our capability to identify patients in this ultra-rare suffering from this ultra-rare disease. You ask about the peak. I mean, they are in the US, if you consider the prevalence, at least 500 patients suffering from APDS. On top of it, we've said that we expect that 20% of the US patients actually could be reclassified as APDS, that could increase the potential of this population by 50%. Then on top of that, Anurag mentioned the efforts that we are making to really leverage the work that has been published in Cell which suggests that APDS prevalence may be far higher. That could be actually an upside. Again, I think there are some very concrete numbers I've shared with you.

Speaker #3: You ask about the peak . I mean , they are in the US . If you consider the prevalence at least 500 patients suffering from APDs on top of it , we've said that we expect that 20% of the US patients actually could be reclassified as APDs , and that could increase the potential by of this population by 50% .

Speaker #3: And then on top of that , Anurag mentioned the efforts that we are that we are making to really leverage the the the work that has been published in cell and which suggests that APDs prevalence may be far higher and that could be actually an upside .

Speaker #3: So again , I think there are some very concrete numbers that I've shared with you . And on top of it , the potential upside , which we cannot quantify today , the the authors suggested up to 100 times .

Fabrice Chouraqui: On top of it, the potential upside which we cannot quantify today. The authors suggested up to one at times. Again, this needs to be verified, and you can see that we have a very concrete and solid plan of action to be able to come back to you with more next year. Hope I've addressed your question, Lucy.

Speaker #3: Again , this needs to be verified . And you can see that we have a very concrete and solid kind of action . To be able to back to you with more next year , hope I address your question .

Speaker #8: Great . Thank you very much .

Lucy Codrington: Great. Thank you very much.

Speaker #2: Thank you . Just a moment , please , for our next question . Next we have Susheela Hernandez from Van Kempen . Please go ahead .

Operator: Thank you. Just a moment, please, for our next question. Next, we have Sushila Hernandez from Van Lanschot Kempen. Please go ahead.

Speaker #9: Hello . Thank you for taking our question . This is Mirtha , for Sheila from Kempa . I have two questions . First , given

[Analyst] (Van Lanschot Kempen): Hello. Thank you for taking our question. This is Mirta for Sushila from Van Lanschot Kempen. I have two questions. First, given your more disciplined approach, what are your priorities for capital allocation? Can we expect another M&A transaction similar in size to Abliva? Second, how is your basket, PID trial progressing? When can we expect something? Thank you very much.

Speaker #9: your priorities for come capital allocation ? Can we expect another M&A transaction similar in size to Ab-liva ? And second , how is your basket ?

Speaker #9: P r I'd trial progressing and can and when can we expect something . Yeah . Thank you very much .

Speaker #3: I think this is Sheila for calling out the the disciplined capital allocation that that's true . And hopefully it was very apparent and with Kenneth joining clearly an extremely happy that given his track record and be able to to really embed that mindset which is absolutely essential if if you want to run a high performing organization , I think as you as you see , we have a number of growth catalysts in our commercial portfolio , in the in the short term , we also have a number of pipeline catalysts next year , in the year to come .

Fabrice Chouraqui: All right. Thank you, Sheila. Thank you for calling out the disciplined capital allocation. That's true, hopefully it was very apparent. With Kenneth joining, clearly, I'm extremely happy that given his track record, I'll be able to really embed that mindset, which is absolutely essential if you want to run a high-performing organization. I think as you see, we have a number of growth catalysts in our commercial portfolio in the short term. We also have a number of pipeline catalysts next year and the year to come. When it comes to value inflection point growth catalysts, we have a lot, we are committed to showing that we can execute.

Speaker #3: So when it comes to value inflection point , growth catalysts , we have a lot and we are committed to showing that we can execute .

Speaker #3: Now , it is true that we have higher ambitions , but there is no rush actually , in doing any any M&A . Obviously , given the the strong .

Fabrice Chouraqui: Now, it is true that we have higher ambitions, but there is no rush actually, in doing any M&A. Obviously, given the strong growth platform, our ability to generate cash, the very strong scalability platform that we have built over the years in clinical development, in supply chain, in commercial, in access, I believe we can be much more ambitious, and we should be looking at the continued expansion of our portfolio and our pipeline. As such, we are continuously looking at potential opportunities to expand our portfolio and pipeline. There is nothing planned. There is no rush. Anything that we would want to do will have to be value accretive for our stakeholders and shareholders. Clearly, this is something that we keep in mind.

Speaker #3: growth platform , our ability to generate cash , the Thank you very strong capability platform that we have built over the years and clinical development , its supply chains and commercial and access , I believe we can be much more ambitious and we should be looking at the continued expansion of our portfolio and our pipeline .

Speaker #3: And as such , we are continuously looking at potential opportunities to expand our portfolio and pipeline . So there is nothing planned . There is no rush , anything that we would want to do will have to be value accretive for our stakeholders and shareholders .

Speaker #3: But clearly this is something that we keep in mind . It is part of the work that we are doing . And if we find the right opportunity , obviously we will engage with our shareholders .

Fabrice Chouraqui: It is part of the work that we're doing. If we find the right opportunity, obviously, we will engage with our shareholders.

Speaker #5: And I think you had asked also about the basket trial . And if you remember , this is a study with multiple genes that can drive the pi3-k pathway .

Anurag Relan: I think you had asked also about the basket PID trial. If you remember, this is a study with multiple genes that can drive the PI3K pathway, a phase II proof of concept study. This study is actually progressing very nicely. We continue to expect readout from the study in H2 2026. A very exciting program along with the CVID program, both on track for H2 2026 readout.

Speaker #5: A phase two proof of concept study . And this is study is actually progressing very nicely . We continue to expect readout from the study in the second half of 26 .

Speaker #5: So a very exciting program along with the Cvid program both on track for second half , 26 readout .

Speaker #9: Thank you .

[Analyst] (Van Lanschot Kempen): Thank you.

Speaker #2: Thank you . Just a moment for our next question , please . Next , we have Joe from H.C. Wainwright . Please go ahead .

Operator: Thank you. Just a moment for our next question, please. Next, we have Joe Pantginis from H.C. Wainwright. Please go ahead.

Speaker #10: Hi . This is Josh on for Joe . Thanks for taking our question . So I just wanted to ask a question about the new formulation .

Josh: Hi, this is Josh on for Joe. Thanks for taking our question. I just wanted to ask a question about the new formulation. If you could give any more color on this new pediatric formulation for the one to six-year-old group, and if there's any specific manufacturing hurdles that you may need to clear for this formulation. Thanks.

Speaker #10: If you could give any more color on this new pediatric formulation for the 1 to 6 year old group . And if there's any specific manufacturing hurdles that you may need to clear for this formulation , thanks .

Speaker #3: Hi , Josh .

Anurag Relan: Hi, Josh. We have indeed a new pediatric formulation for the youngest population. Again, because this youngest population of children are, won't be expected to be able to swallow a tablet, which we currently have available for the older kids as well as the adolescents. These are, for this youngest population, the formulation is granules. These granules, we've manufactured them, we've done PK work on them, and we, you know, we've actually completed the study with this 1 to 6-year-old population. We expect to follow a similar process in terms of the regulatory path. We've engaged with FDA, both with discussions on the formulation, but as well as on the study design. I think all of it is, remains on track.

Speaker #5: So we have indeed a new pediatric formulation for the youngest population . Again , because this youngest population of children are wouldn't be expected to be able to swallow a tablet , which we currently have available for the the older kids as well as the adolescents .

Speaker #5: These are for this youngest population . The formulation is granules . And so these granules we manufactured them . We've done PK work on them and we you know , we're going through the process .

Speaker #5: We've actually completed the the study . And with this 1 to 6 year old population . So we expect to follow a similar process in terms of the regulatory path .

Speaker #5: And obviously we've engaged with FDA both with discussions on the formulation . But as well as on the study design . So I think all of it is remains on track .

Josh: All right. Thank you so much.

Speaker #10: Thank you so much .

Speaker #2: Thank you . Next we have Natalia Webster from RBC . Please go ahead .

Operator: Thank you. Next, we have Natalia Webster from RBC. Please go ahead.

Speaker #11: Hi there . Thanks for taking my questions . Firstly , I just wanted to ask around your revenue guidance uplift . Just confirming how much of this comes from better than expected ruconest versus Joenja .

Natalia Webster: Hi there. Thanks for taking my questions. Firstly, I just wanted to ask around your revenue guidance uplift, just confirming how much of this comes from better than expected RUCONEST versus Joenja. In particular for RUCONEST, how are you expecting that to develop into Q4 in 2026, given that you're not seeing much pressure from competition and also continue to see increases in prescribers and patients there? My second question's on Joenja and the international rollout. It seems that this is contributing around 11% this quarter. Curious to hear a bit more about how that's evolving and how you expect that mix to evolve over time. Thirdly, just around the RUCONEST withdrawal from ex-US markets.

Speaker #11: And then in particular for Ruconest . How are you expecting that to develop into Q4 in 2026 , given that you're not seeing much pressure from competition and also continue to see increases in prescribers and patients , there ?

Speaker #11: My second question is on Jeongja and the international rollout , it seems that this is contributing around 11% . This quarter . So curious to hear a bit more about how that's evolving and how you expect that mix to evolve over time .

Speaker #11: And then thirdly , just around the Ruconest withdrawal from ex-US markets , are you able to comment a bit on the savings you'll make from this and where you plan to redirect those resources ?

Natalia Webster: Are you able to comment a bit on the savings you'll make from this and where you plan to redirect those resources? Thank you.

Speaker #11: Thank you .

Speaker #3: Thank you . Natalia . So when it comes to our revenue guidance , as as Kenneth said , it was driven by the continued strength of of our business .

Fabrice Chouraqui: Thank you, Natalia. When it comes to our revenue guidance, as Kenneth said, it was driven by the continued strength of our business that we've seen in Q3 and throughout the year in 2025. Obviously, RUCONEST plays an important role because of the size of the drug, of the RUCONEST revenues, in the total size of the revenues. This upgrade is driven by both obviously the continued performance of RUCONEST and also the continued performance of Joenja. As Kenneth said, you know, the new guidance suggests a growth for the year between 23% and 26%.

Speaker #3: That we've seen in , in Q3 and throughout the , the year in 2025 . So obviously Ruconest plays an important role because of the size of the of of of the drug of the ruconest revenues in the total size of the revenues .

Speaker #3: But this this upgrade is driven by both , obviously , the continued performance of Ruconest and also the continued performance of of Ginger as Kenneth said , you know , the new guidance suggests a growth for the year between 23 and 26% .

Speaker #3: We have not yet provided guidance for for next year , but as we mentioned during the call , we expect Ruconest to continue to grow as it is serving a differentiated population and has a unique value proposition for these more severe patients .

Fabrice Chouraqui: We have not yet provided guidance for next year, but as we mentioned during the call, we expect RUCONEST to continue to grow as it's serving a differentiated population and has a unique value proposition for these more severe patients. Obviously, the acceleration of the growth of Joenja. Acceleration because until now we were able to source patients from only a unique source of business, the 12-year-old plus APDS patient population, and that tomorrow we'll be able to unlock new source of business with the expected expansion of the label to the pediatric population. That will add a significant number of patients. We have already identified 54 patients, that's a large number of patients. A third of whom are already on drug, which we'll be able to convert, I hope, and fast.

Speaker #3: And obviously , the acceleration of the growth of Georgia acceleration , because until now we were able to source patients from only a unique source of business .

Speaker #3: The 12 year old plus APDs patient population . And that tomorrow we'll be able to unlock new source of business with the expected expansion of of the label to the pediatric population .

Speaker #3: That will add a significant number of patients . We have already identified 54 patients . That's a large number of patients . A third of whom are already on drug , which will be able to convert .

Speaker #3: I hope , and fast . And then obviously , having already identified patients , these patients are more likely to be put on drug .

Fabrice Chouraqui: Then, obviously, having already identified patients, these patients are more likely to be put on drug, and we will continue our efforts to identify more patients. Then we have other growth opportunities that we have elaborated upon in detail, the US, and then the geo expansion. That was actually one of your points. I think the launch in the UK is going very well. We are very encouraged to see this. I think that shows our ability to launch a drug like Joenja in other countries. We have selected eight markets outside of the US where we believe we can develop a significant business for Joenja. We will roll out this strategy.

Speaker #3: And we will continue our efforts to identify more patients. And then we have other growth opportunities that we have elaborated upon in detail.

Speaker #3: The the US and then the Geo expansion that was actually one of your points . I think the the , the launch in the UK is is going very well .

Speaker #3: So we are very encouraged to see this . I think that shows our ability to launch a drug like Georgia in other countries .

Speaker #3: We have selected eight markets outside of the US where we believe we can develop a symptom business for ginger and and so we will we will roll out this this strategy obviously we are we will be we will make sure that reimbursement authorities in these countries reimburse the the drug at the right price .

Fabrice Chouraqui: Obviously, we'll make sure that reimbursement authorities in these countries reimburse the drug at the right price. It's absolutely. The goal is not to launch just for the sake of launching. We have access program in place to allow patients to benefit from the drug at the present time. Obviously, we are not a philanthropic company, and we need to have our drug reimbursed, but it cannot be done at any cost. We will be working actively on this. When it comes to the RUCONEST withdrawal, as I said, we have to be more disciplined in the way we allocate our capital. Clearly, we felt that maintaining the commercialization of RUCONEST in these countries was not financially sustainable.

Speaker #3: It's absolute . So the goal is not to launch just for the sake of launching . We have access program in place to allow patients to benefit from the drug .

Speaker #3: At the present time . Obviously , we are not a philanthropic company and we need to to have our drug reimbursed , but it cannot be done at any cost .

Speaker #3: And we will be working actively on this when it comes to the recognized withdrawal . As I said , we have to be more disciplined in the way we allocate our capital .

Speaker #3: We felt clearly , we felt that maintaining the commercialization of ruconest in this , in this countries was not financially sustainable . Will pay great care to ensuring great attention , to insure that patients can continue to access the right treatment in terms of financial implications , it's difficult to quantify .

Fabrice Chouraqui: We'll take great care to ensuring great attention, to ensure that patients can continue to access the right treatment. In terms of financial implication, it's difficult to quantify. It's gonna be minimal. I mean, you know that actually the vast majority of revenues came from the US. I don't expect, you know, meaningful impact whether on the top line and in the bottom line. This is actually combined with our financial discipline efforts to really manage our cost structure more tightly.

Speaker #3: It's going to be minimal . I mean , you know that actually the vast majority of revenues came from from the US . So I don't expect , you know , meaningful impact , whether on the top line and in the bottom line , this is actually combined with our financial discipline efforts to , to to really manage our , our cost structure more tightly .

Speaker #11: Great . Thank you .

Natalia Webster: Great. Thank you.

Speaker #12: Thank you .

Fabrice Chouraqui: Thank you.

Speaker #2: Thank you . Our last question comes from the line of Simon Scholes from First Berlin . Please go ahead .

Operator: Thank you. Our last question comes from the line of Simon Scholes from First Berlin. Please go ahead.

Speaker #13: Yes . Good afternoon . I've just got two questions . So you recorded a gross margin of 92.7% in the third quarter , which I think compares with 90% in H1 and 89% in 24 .

Simon Scholes: Yes, good afternoon. I've just got two questions. You recorded a gross margin of 92.7% in Q3, which I think compares with 90% in H1 and 89% in 2024. I was just wondering how we should think about the gross margin in your existing markets going forward. Do you think this 92%, this 93%, is sustainable going forward? You also say in the presentation, I mean, you've seen an increase in more severe frequent attack patients. Does that mean that these more severe frequent attack patients are actually increasing as a proportion of the overall number of patients?

Speaker #13: I was just wondering how we should think about the gross margin in your existing markets going forward . And do you think this 92 , this 93% is sustainable going forwards and then you also say in the presentation , I mean , you say you've got a you've seen an increase in more severe frequent attack patients .

Speaker #13: Does that mean that these more severe frequent attack patients are actually increasing as a proportion of the overall number of patients ?

Speaker #3: So I'll start with the latter , and I'll let Kenneth actually elaborate on the on the gross margin point . So it is true that Ruconest is serving a quite distinctive population in the on demand markets .

Fabrice Chouraqui: I'll start with the latter, and I'll let Kenneth actually elaborate on the gross margin point. It is true that RUCONEST is serving a quite distinctive population in the on-demand market, more severe patients. By more severe patients, I mean patients who are having more severe crisis, often life-threatening crisis, and more frequent crisis. That's basically the bulk of the patients. As the sales of, as the revenue of RUCONEST developed, we see that pattern being reinforced. RUCONEST is a drug that is primarily used on more severe patients. Patients who are having more severe crisis, more frequent crisis. I don't think that will change. I think there'll be other treatment options for other type of patients.

Speaker #3: More severe patients and by most severe patients , I mean , patients who are having more severe crisis , often life threatening crisis and more frequent crises .

Speaker #3: And . So that's basically the the bulk of the of the patient . And so as the cells of , as the revenue of ruconest developed , we see that pattern being reinforced .

Speaker #3: So Ruconest is a drug that is primarily used on more severe patients , patients who are having more severe crisis , more frequent crises .

Speaker #3: And I don't think that that will change . I think there'll be other treatment options for other type of patients . And Ruconest will be able to continue to to serve those patients .

Fabrice Chouraqui: RUCONEST will be able to continue to serve those patients, leveraging again, the reliability that it has built among this patient category and with prescribers. I think that also illustrate the fact that quarter after quarter, although 10 years on the market, we see more prescribers using the drug. When it comes to the gross margin, I'll let Kenneth elaborate.

Speaker #3: Leveraging again , the the reliability that is built . Among these patient category and and with with fresh products . And I think that's also illustrates the fact that quarter after quarter , although ten years on the market , we see more prescribers using the drug .

Speaker #3: When it comes to the gross margin , I'll let's Kenneth elaborate .

Speaker #6: Yeah . Thank you . Thank you . Fabrics . And thanks for the thanks for the question . It's obvious that we have a high gross margin and it's impacted also by the mix of sales and , you know , across different geographies .

Kenneth Lynard: Yeah, thank you. Thank you, Fabrice, and thanks for the question. It's obvious that we have a high gross margin, and it's impacted also by the mix of sales, and, you know, across different geographies. As you see, so say the Joenja share growing, and faster growing than RUCONEST, we're having a benefit coming from that. We don't wanna kind of, you know, give specifics in terms of the forward-looking performance. I think you have seen, kind of, you know, a slight increase on a continuous basis as we start to build out the Joenja sales to a larger extent. I think year-to-date performance is very encouraging.

Speaker #6: As you see . They share a growing and faster growing than Ruconest . We're having a benefit coming coming from that . So we don't want to kind of , you know , give specifics in terms of the forward looking performance .

Speaker #6: But I think you seen kind of , you know , a slight increase on a continuous basis as we start to build out the ginger sales to a larger extent .

Speaker #6: So thank you . Three's performance is very encouraging . But we are not at this point in time , giving the specifics around forward looking .

Kenneth Lynard: We're not at this point of time giving the specifics around forward-looking, but think about it in that context of the Durenza share growth.

Speaker #6: But think about it in that context of the joint growth .

Speaker #13: Okay . Thanks very much .

Simon Scholes: Okay. Thanks very much.

Speaker #2: Thank you. That concludes the Q&A session. I will now hand back to Fabrice for closing remarks.

Operator: Thank you. That concludes the Q&A session. I will now hand back to Fabrice for closing remarks.

Speaker #3: Thank you very much . Operator . Thank you all for attending this call and for your continued interest in in our company . With that , I'll I'll close the call .

Fabrice Chouraqui: Thank you very much, operator. Thank you all for attending this call and for your continued interest in our company. With that, I'll close the call. Thank you.

Speaker #3: Thank you .

Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.