Pharming Group - Earnings Call - Q3 2025

Transcript

Operator (participant)

Today, 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. After the speaker's presentation, there will be a Q&A session. To ask a question during the session, you'll need to press * one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press * one and one again. 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. Please go ahead.

Fabrice Chouraqui (CEO)

Thank you, Operator. Good morning and good afternoon, everyone, and welcome to the Pharming 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 plan. 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 the third quarter of 2025 versus the same quarter last year. Operating profit jumped to $15.8 million, nearly four times last year's result. Operating cash flow came at $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 Stephen will elaborate upon in a minute. Joenja's third-quarter 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, and when looking ahead, we anticipate adding new sources of growth with the pediatric indication, the reclassification of VUS patients, and our geographic expansion.

The strong momentum for our two commercial assets supports an upgrade to our full-year 2025 revenue guidance to $360-$365 million from the previous $335-$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 prospect. 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, 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 $1 billion sales potential each. As we've seen, Ruconest continues to grow double-digit after 10 years on the market.

Its unique value for severe HAE patients and specific manufacturing process makes 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 billion-dollar-plus opportunity with a positive futility analysis in the ongoing registry study. 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 Stephen, who will discuss our commercial progress during the quarter and elaborate on the continued strong growth of Ruconest and Joenja.

Stephen Toor (Chief Commercial Officer)

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 six quarters, which leads directly to the high level of new patient enrollments and the volume increase over prior year, which is at 28% versus the first nine months of 2024. Pharming's 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 sebetralstat, 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. 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 four and a half hours, with the vast majority within 24. 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 +35%, generating $15.1 million in revenue for the quarter. The number of U.S. patients on paid therapy is up 25% versus Q3 2023. 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 2023, with the total number of APDS patients in the U.S. now at 270. Importantly, the resulting significant increase in patients versus 2023 and patients' consistently high adherence to therapy is driving this strong revenue growth. The launch of Joenja in the U.K. 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 January 31, 2026. Our preparations for launch, after being expected to be approved 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. 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 will discuss our development programs and the forthcoming data presentations at the American College of Allergy, Asthma, and Immunology later this week in Orlando.

Anurag Relan (Chief Medical Officer)

Thanks, Stephen. In addition to the commercial successes in the quarter, we continue to advance our pipeline in the past three months. In APDS, as you mentioned, Stephen, 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 two proof-of-concept studies for PIDs with immune dysregulation, and 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.

As you 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. 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. We started a number of activities now to help answer these questions.

First, we're convening a global KOL and 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 the goal 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. 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 HIV patients' experience with Ruconest across a number of clinically relevant outcomes. In addition, an indirect treatment comparison with sebetralstat will be presented, providing additional evidence for the unique benefits that Ruconest offers HIV patients. On the APDS side, we have posters 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 improvement seen in the study. I'll turn it over now to Kenneth, our newest member of the team, to review our financials.

Kenneth Lynard (CFO)

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 $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 $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 $16.0 million compared to $4.1 million last year. That came from growth in revenues, the improved gross margin, and well-managed operating cost. Cash and marketable securities increased from $130.8 million at the end of the second quarter to $168.9 million.

At the end of Q3. This increase was driven by significant cash flow from operating activities with $32 million. As Fabrice 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 $269.6 million due to strong double-digit revenue growth for both products, and gross profit grew by 35%. Operating expenses increased by $29.2 million, excluding $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, was $29.7 million, which compared to a loss of $15.3 million for the first nine months of 2024. 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're raising our 2025 total revenue guidance to $365 million-$375 million, up from $335 million-$350 million. This implies full-year revenue growth between 23%-26%. The increase is due to continued strong performance and outlook for the remainder of the year. We continue to expect total operating expenses between $304 million-$308 million. This assumes constant foreign exchange rate for the remainder of the year, includes $10.2 million of non-recurring Abliva acquisition-related transaction expenses, and excludes approximately $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 cost.

Going forward, we'll further accelerate setting the foundation for strong financial discipline with investments into areas that matter 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. 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. With that, let me hand back now to Fabrice for closing remarks.

Fabrice Chouraqui (CEO)

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 remainder 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 a meaningful value creation catalyst for shareholders.

We are also taking decisive steps to enhance financial discipline, including optimizing G&A accounts to ensure efficient capital allocation and maximizing our return. I would 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. We are very excited to welcome Leigh Vernon March as our new Chief Commercial Officer to drive the next phase of commercial growth. Let me now open the line for questions.

Operator (participant)

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

Jeff Jones (Senior Analyst)

Good morning, guys. Good afternoon. Thanks for taking the question. 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 oral that has come onto the market? Where do you see it being adopted? 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.

Fabrice Chouraqui (CEO)

Thank you so much, Jeff, for your question. On Ruconest, clearly, we do not see Ruconest competing head-to-head with sebetralstat. That is why I cannot comment on how sebetralstat is doing. As I mentioned, I believe we have a highly distinctive, valuable position that serves a different type of patients, more severe patients. This is due to a unique mode of action that replaces 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 is 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. 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 bolus of patients to come on drug. This will then add to the patients that are already identified. We will strive hard to ensure that they can benefit from Ruconest. 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 the doctors decide so, and 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 is a large number. We believe that the expansion of the 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.

Jeff Jones (Senior Analyst)

Thank you very much for answering the questions, Fabrice.

Fabrice Chouraqui (CEO)

Thank you.

Operator (participant)

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

Lucy Codrington (Associate Research Analyst)

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 sebetralstat, given I'm totally understanding the different positionings of the drugs, 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, in terms of the VUS opportunity, are you happy with the rate at which—I mean, my understanding was we might start to see VUS patients in the second half.

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? 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? 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.

Fabrice Chouraqui (CEO)

Thank you, Lucy. I'll try to cover all your questions. I'll start with Ruconest and your questions related to the listing of Ruconest in some countries in Europe. We plan to complete this by the first quarter, end of the first quarter, first half of next year. When it comes to, and again, this is really driven by the fact that we do not 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 deploy our capital appropriately. 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, actually, I mean, I said that clearly.

For me, the Ruconest and actually are serving two different types of patients. As such, I do not see a significant threat for Ruconest. I mean, Ruconest is a drug that has a unique mode of action that replaces the missing or deficient protein underlying the biology of the disease. Ruconest has a very unique mode of administration that allows a very fast onset of action. As such, it has a unique valuable position for more difficult-to-treat patients. That is why the vast majority of patients on Ruconest are more severe patients, are patients that often have failed other treatments, are patients that need actually that level of efficacy, that speed of onset to really address their more frequent and more severe crises. Moving to Joenja and your question about VUS. 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 VUS patients to be reclassified as APDS. We have obviously to remain arm-length, obviously, to what's happening. We 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. 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 need to be reclassified, then they'll call the doctors, 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 Joenja. It 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. That shows our capability to identify patients suffering from this ultra-rare disease. You ask about the peak. I mean, there 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 VUS patients actually could be reclassified as APDS, and that could increase the potential of this population by 50%. On top of that, Anurag mentioned the efforts that we are making to really leverage 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.

Again, I think there are some very concrete numbers I've shared with you. On top of it, the potential upside, which we cannot quantify today. The authors suggested up to 100 times. 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.

Lucy Codrington (Associate Research Analyst)

Great. Thank you very much.

Operator (participant)

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

Merethe Forsila (Senior Responsible Investment Adviser)

Hello. Thank you for taking our question. This is Merethe Forsila 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 to start that? Yeah. Thank you very much.

Fabrice Chouraqui (CEO)

Hi, Sushila. Thank you for calling out the disciplined capital allocation. That's true, and 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, and we are committed to showing that we can execute. 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.

Capability platform that we have built over the years. In clinical development, in supply chains, 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-appreciative for our stakeholders and shareholders. Clearly, this is something that we keep in mind. It is part of the work that we're doing. If we find the right opportunity, obviously we will engage with our shareholders.

You had asked also about the basket PID trial.

This is a study with multiple genes that can drive the PI3K pathway, a phase two proof of concept study. This study is actually progressing very nicely. We continue to expect readout from the study in the second half of 2026. A very exciting program along with the CVID program, both on track for second half 2026 readout.

Merethe Forsila (Senior Responsible Investment Adviser)

Thank you.

Operator (participant)

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

Joe Pantginis (Managing Director Equity Research)

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.

Fabrice Chouraqui (CEO)

Hi, Josh. We have indeed a new pediatric formulation for the youngest population. Again, because this youngest population of children would not be expected to be able to swallow a tablet, which we currently have available for the older kids as well as the adolescents. For this youngest population, the formulation is granules. These granules, we have manufactured them. We have done PK work on them, and we are going through the, we have actually completed the study with this one to six-year-old population. We expect to follow a similar process in terms of the regulatory path. Obviously, we have engaged with FDA both with discussions on the formulation, as well as on the study design. I think all of it remains on track.

Joe Pantginis (Managing Director Equity Research)

Thank you so much.

Operator (participant)

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

Natalia Webster (Equity Research Senior Associate)

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, 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.

Fabrice Chouraqui (CEO)

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 have 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, the new guidance suggests a growth for the year between 23% and 26%. 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 is 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 will 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 is a large number of patients, a third of whom are already on drug, which we will be able to convert, I hope, and fast. 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. We have other growth opportunities that we have elaborated upon in detail, the BUS, and then the geo-expansion. That was actually one of your points. I think the launch in the U.K. 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. Obviously, we will make sure that reimbursement authorities in these countries reimburse the drug at the right price. The goal is not to launch just for the sake of launching. We have an 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. It cannot be done at any cost, and 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. We'll pay great care to ensure 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 going to be minimal. I mean, you know that actually the vast majority of revenues came from the US. I don't expect 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.

Natalia Webster (Equity Research Senior Associate)

Great. Thank you.

Fabrice Chouraqui (CEO)

Thank you.

Operator (participant)

Thank you. Our last question comes from Alliance of Assignment Schools from First Berlin. Please go ahead.

Yes. Good afternoon. I've just got two questions. You recorded a gross margin of 92.7% in the third quarter, which I think compares with 90% in the first half 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 93% is sustainable going forward? You also say in the presentation, I mean, you said 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?

Fabrice Chouraqui (CEO)

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 crises, often life-threatening crises, and more frequent crises. That's basically the bulk of the patients. 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 crises, more frequent crises. I don't think that that will change. I think there'll be other treatment options for other types of patients. Ruconest will be able to continue to serve those patients, leveraging, again, the reliability that is built among this patient category.

With prescribers. I think that also illustrates 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.

Kenneth Lynard (CFO)

Yeah. Thank you. Thank you for briefs. 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 across different geographies, as you see. Joenja share is growing and faster growing than Ruconest, we're having a benefit coming from that. We don't want to kind of give specifics in terms of the forward-looking performance, but I think you've seen kind of a slight increase on a continuous basis as we start to build out the Joenja sales to a larger extent.

I think Q3's performance is very encouraging, but we're not at this point of time giving the specifics around forward-looking, but think about it in that context of the Joenja share growth.

Okay. Thanks very much.

Operator (participant)

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

Fabrice Chouraqui (CEO)

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.

Operator (participant)

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