PHARMING GROUP N.V./Earnings transcript

November 6, 2025

2025 earnings call transcript

Issuer IR↗

PHARMING GROUP N.V.

Pharming Group N.V. 3Q 2025 Results Call

November 6, 2025

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CORPORATE PARTICIPANTS CONFERENCE CALL PARTICIPANTS

Fabrice Chouraqui – Chief Executive Officer Jeffrey Jones – Oppenheimer

Stephen Toor – Chief Commercial Officer Lucy Codrington – Jefferies

Anurag Relan – Chief Medical Officer Sushila Hernandez – Van Lanschot Kempen

Kenneth Lynard – Chief Financial Officer Joshua Korsen – H.C. Wainwright

Natalia Webster – RBC

Simon Scholes – First Berlin

Fabrice Chouraqui – Chief Executive Officer:

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.

Slide 5:

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, and operating profit jumped to US$15.8 million, nearly 4x last year's result.

Operating cash flow came at US$32 million, putting 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® third quarter revenue increased by 35%, compared to third quarter 2024, reflecting the

25% year-on-year growth in patients on treatment and our increasing success in finding new APDS patients. The drug continues its uptake in the 12-year+ APDS segment. And when looking ahead, we anticipate adding new sources of growth with the pediatric indication, the reclassification of the

VUS patients and our geographic expansion.

This strong momentum for our two commercial assets support an upgrade to our full year 2025 revenue guidance to US$365-375 million from the previous US$335-350 million, for which Kenneth will provide more details later in the call.

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

Slide 6:

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 US$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 US$1 billion-plus opportunity with a positive futility analysis in the ongoing registrational 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.

Slide 7:

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®.

Stephen Toor – Chief Commercial Officer:

Thank you, Fabrice. Good morning, everybody.

Slide 9:

As Fabrice said, RUCONEST® has delivered another very successful quarter with high double-digit growth of US$82.2 million in revenue, which is up 29% on Q3 of last year. This 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 enrollment and the vial volume increase over prior year, which is at +28% versus the first nine months of 2024.

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Pharming's sustained success, unabated by the recent launch of an oral acute 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.

Slide 10:

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 Icatibant, which have not been effective for them often leading to the need to re-dose to stop their HAE attack.

As the only recombinant C1-INH 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 re- dose 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 within 4.5 hours with the vast majority within 24 hours. That efficacy is both critical and reassuring, and that is direct feedback from the patients we serve.

Slide 11:

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 US$15.1 million in revenue for the quarter.

The number of U.S. 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.

We're finding patients faster than we did in 2024 with a total number of APDS patients in the U.S. now at 270.

Importantly, the resulting significant increase in patients versus 2024, 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.

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Slide 12:

Now let’s review the next significant inflection point, which is the pediatric launch in the U.S. 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 the expected approval in January are on track.

As we approach the U.S. pediatric launch, the team has already identified 54 patients diagnosed with APDS aged 4 to 11. A 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. So 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, Steve.

Slide 14:

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, 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, and these are also on track for readouts in the second half of 2026.

And then our newest addition to the pipeline is also progressing nicely, KL1333 in a registrational study for Primary Mitochondrial Disease, where study enrollment and site activation are advancing, and we continue to expect a readout in late 2027.

Slide 15:

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 100x higher than

Pharming Group N.V. Page 4/14 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 have now started a number of activities 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 the goal then to be able to apply the model to large EMR databases.

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 VUS resolution project.

So much more to come on this exciting work.

Slide 16:

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 re-analysis 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 sebetralstat will be presented, providing additional evidence for the unique benefits that RUCONEST® offers HAE 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 – Chief Financial Officer:

Thank you, Anurag.

Slide 18:

As the new CFO, I'm excited to have joined Pharming at such an exciting time and to have the opportunity to provide more color on our strong financial performance and outlook. Q3 was an excellent quarter with revenues at US$97.3 million, up 30% versus the same quarter last year.

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We saw high double-digit revenue growth for both RUCONEST® and Joenja®. Gross profit grew by

33% to US$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 US$16.0 million compared to US$4.1 million last year. That came from growth in revenues, the improved gross margin and well-managed operating costs. Cash and marketable securities increased from US$130.8 million at the end of the second quarter to US$168.9 million at the end of Q3. This increase was driven by significant cash flow from operating activities with US$32 million.

And 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.

Slide 19:

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 US$269.6 million due to strong double- digit revenue growth for both products and gross profit grew by 35%.

Operating expenses increased by US$29.2 million, excluding US$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 US$29.7 million, compared to a loss of US$15.3 million for the first nine months of 2024. Cash flow from operating activities was

US$44.0 million in the first nine months of the year.

Slide 20:

Following the strong results for the first nine months, we are raising our 2025 total revenue guidance to US$365-375 million, up from US$335-350 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.

We continue to expect total operating expenses between US$304-308 million. This assumes constant foreign exchange rates for the remainder of the year, includes US$10.2 million of non- recurring Abliva acquisition-related transaction expenses and excludes approximately US$7 million in one-time restructuring costs in Q4 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 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 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 a great opportunity to sharpen our focus on profitable growth, effectively allocate capital to

Pharming Group N.V. Page 6/14 maximize return on investments and improve transparency and predictability in our financial reporting. And with that, let me hand back now to Fabrice for closing remarks.

Fabrice Chouraqui – Chief Executive Officer:

Slide 22:

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 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 proportion 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. And we are also taking decisive steps to enhance financial discipline, including optimizing G&A headcount to ensure efficient capital allocation and maximize returns.

I'd like to end by expressing my sincere gratitude to Steve Toor for his contribution 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.

QUESTIONS AND ANSWERS

Operator

(Operator Instructions) First question comes from Jeff Jones of Oppenheimer.

Jeffrey Jones (Oppenheimer): 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 on to the market? Where do you see it being adopted? Do you anticipate any pressure on your patient base?

And then 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?

Fabrice Chouraqui

Thank you so much, Jeff, for your question.

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So on RUCONEST®, I mean clearly, we don't see RUCONEST® competing head-to-head with sebetralstat. And so that's why I cannot comment 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. And 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. 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 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 U.S. 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. And 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 that we will strive hard to ensure that they can benefit from Joenja®. And then will 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 that will probably come on drug if the doctors decide so. And then new patients that you identify.

So really, that sequence will probably happen next year. And given the number of patients that we have already identified, 54, it's a large number, we believe that the expansion of 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+ segment.

Operator

Next, we have Lucy Codrington from Jefferies.

Lucy Codrington (Jefferies): 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, I was late joining. The plan to stop RUCONEST® outside of the U.S., have you given a timeframe on when that will become effective?

And then just in terms of the competitive threat from Ekterly. I'm totally understanding the different positioning of the drugs. But how often are typically HAE patients seen by their specialist if there were to be any switching for that to potentially become apparent?

And then moving on to Joenja®. In terms of the VUS opportunity, are you happy with the rate at which this -- I mean my understanding is we might start to see VUS patients in the second half. And

I noticed that the kind of details with your outlook no longer kind of suggest that. So is that

Pharming Group N.V. Page 8/14 something that you think is now more likely to be pushed into 2026? And what is the process for

VUSs outside of the U.S.?

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%. 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

U.S.? Sorry for so many.

Fabrice Chouraqui

Thank you, Lucy. I'll try to cover all your questions.

So 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 the 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 don't see the commercialization of RUCONEST® in these countries that's 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 treatment and if needed, ensure continuity of supply of RUCONEST® through compassionate use access mechanism.

When it comes to Ekterly, I mean I said that clearly, for me, that RUCONEST® and Ekterly are serving two different types of patients. And 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 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. And as such, it has a unique value proposition for more difficult-to-treat patients. That's 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 crisis.

All right, moving to Joenja® and your question about the U.S. as Anurag said, test labs are in ongoing conversations with the researchers, which published this paper in Cell. And we expect that over time about 20% of VUS patients to be reclassified as APDS.

We have obviously to remain at arm’s 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 U.S., 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 test labs feel that those patients needs to be reclassified, then they'll call the doctors and then the doctors will probably reach out to the patients.

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The adherence rate, 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 identified 13 new APDS patients in the U.S. in Q3. That shows our capability to identify patients suffering from this ultra-rare disease. You asked about the peak. I mean there are in the U.S., 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 VUS patients actually could be reclassified as APDS, and that could increase the potential of this population by 50%. And then 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.

So again, I think there are some very concrete numbers I've shared with you. And on top of it, the potential upside, which we cannot quantify today. The authors suggested up to 100x. 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 come back to you with more next year.

I hope I have addressed your question, Lucy.

Operator

Next we have Sushila Hernandez from Van Lanschot Kempen.

Sushila Hernandez (van Lanschot Kempen): This is Myrthe on 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? And second, how is your basket PID trial progressing? And when can we expect top line?

Fabrice Chouraqui

Hi, thank you. Thank you for calling out the disciplined capital allocation. That's true. And hopefully, it was very apparent. And 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.

So when it comes to value inflection points, growth catalysts, we have a lot, and we are committed to showing that we can execute.

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 capability platform that we have built over the years in clinical development, in supply chain, in commercial,

Pharming Group N.V. Page 10/14 in market access, I believe we can be much more ambitious, and we should be looking at the continued expansion of our portfolio and our pipeline. 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. But clearly, this is something that we keep in mind. It is part of the work that we're doing. And if we find the right opportunity, obviously we will engage with our shareholders.

Anurag Relan

And I think you had asked also about the basket PID trial. And if you remember, this is a study with multiple genes that can drive the PI3K pathway, a Phase II proof-of-concept study.

And this study is actually progressing very nicely.

We continue to expect readout from the study in the second half of 2026. So a very exciting program, along with the CVID program, both on track for second half 2026 readout.

Operator

Next we have Joe Pantginis from H.C. Wainwright.

Joshua Korsen (H.C. Wainwright): This is Josh on for Joe. So 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 1- to 6-year-old group? And if there's any specific manufacturing hurdles that you may need to clear for this formulation?

Anurag Relan

Josh, so we have indeed a new pediatric formulation for the youngest population, again, because this youngest population of children wouldn't 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. And so these granules, we've manufactured them, we've done PK work on them, and we've actually completed the study with this 1- to 6-year-old population. So we expect to follow a similar process in terms of the regulatory path.

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 remains on track.

Operator

Next, we have Natalia Webster from RBC.

Natalia Webster (RBC): 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®. And then in particular, for RUCONEST®, how you're expecting that to develop into Q4 and 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 is on Joenja® 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?

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And then thirdly, just around the RUCONEST® withdrawal from ex U.S. markets. Are you able to comment a bit on the savings you'll make from this and where you plan to redirect those resources?

Fabrice Chouraqui

Thank you, Natalia.

So 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.

So obviously RUCONEST® plays an important role because of the size of the drug, of the RUCONEST® revenues in the total size of the revenues. But 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's serving a differentiated population and has a unique value proposition for these more severe patients. And 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+ 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. And 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. And then we have other growth opportunities that we have elaborated upon in detail, the U.S. and then the geo expansion.

That was actually one of your points.

I think the launch in the U.K. is going very well. So 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 U.S. where we believe we can develop a significant business for Joenja®. And so we will roll out this strategy.

Obviously we will make sure that reimbursement authorities in these countries reimburse the drug at the right price. It's absolute. So the goal is not to launch just for the sake of launching. We have access programs 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, 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

Pharming Group N.V. Page 12/14 these countries was not financially sustainable. We'll take great care and attention to ensure that patients can continue to access the right treatment.

In terms of financial implications, 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 U.S. So 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.

Operator

Our last question comes from the line of Simon Scholes from First Berlin.

Simon Scholes (First Berlin): 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 2024. I was just wondering how we should think about the gross margin in your existing markets going forward? So, do you think this 93% is sustainable going forward?

And then 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

So I'll start with the latter, and I'll let Kenneth actually elaborate on the gross margin point.

So it is true that RUCONEST® is serving a quite distinctive population in the on-demand market, more severe patients. And by more severe patients, I mean patients who are having more severe crises, often life-threatening crises and more frequent crises. And so that's basically the bulk of the patients. And so as the revenue of RUCONEST® developed, we see that pattern being reinforced.

So RUCONEST® is a drug that is primarily used on more severe patients, patients who are having more severe crisis, more frequent crisis. And I don't think that, that will change.

I think there will be other treatment options for other types of patients. And RUCONEST® will be able to continue to serve those patients, leveraging, again, the reliability that is built among this patient category and with prescribers. And 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

Yes. 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 across different geographies. As you see, so to say, the Joenja® share growing and faster growing than

RUCONEST®, we're having a benefit coming from that. So we don't want to kind of give specifics in terms of the forward-looking performance, but I think you have seen kind of a slight increase on a continuous basis as we start to build out the Joenja® sales to a larger extent.

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

Operator

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

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.

Operator

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

[END OF TRANSCRIPT]

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