Pharming Group N.V.

Good day and thank you for standing by. Welcome to the Farming Group N.V. Q3 2026 results conference call and webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today. Kenneth Lynard, please go ahead.

Thank you, operator. Good morning and good afternoon, everyone. And thank you for joining Farming's third quarter 2026 call. I'm joined today by Leverne Marsh, my fellow interim co-CEO and our chief commercial officer, and Dr. Anurag Relan, our chief medical officer. After my opening remarks, Leverne will review our commercial performance, Anurag will cover R&D, and I'll return to take you through the financials and outlook before we open the line for questions. As you know, on September 29th, stepped down as CEO, and the board appointed Leverne and me as interim co-CEOs while it conducts a formal search for permanent successor. As of now, there are no additional updates to report, and despite these changes, our strategy, pipeline, and commitment to patients remain unchanged. Before we begin, Please note that we will be making forward-looking statements on this call. These are based on our current expectations and plans, and actual results may differ materially. Please refer to the full statement on this slide. We are pleased to report a strong third quarter performance. Before I go further, I want to comment on why we decided to report results today rather than on November 5th as originally scheduled. Because our third quarter results came in above analyst consensus, we did so on October 22nd in a pre-release with top line revenues and operating expenses only. We appreciated that once these numbers were public, investors would want to see the full details behind the numbers as soon as possible and have the opportunity to ask questions. As a result, we moved the date up for our full third quarter disclosure to today. The change in date is not related to any transaction or restructuring of the company. Getting back to this slide, as many of you know, as many of you have followed farming know, our strategy rests on three pillars. RUCONEST continues to provide a durable source of cash flow, and I'm pleased to report it has returned to growth this quarter. Gioenja, a high growth asset still early in its life cycle, is expanding geographically and with a new pediatric indication. And a high value clinical pipeline with two potential billion dollar opportunities. Leniolisib in broader primary immunodeficiencies, including CVID, and napasimone in mitochondrial DNA-driven primary mitochondrial disease. Turning to the quarter in more details, total revenue grew 21% to $117.6 million ahead of market expectations. This quarter, Rucanest's return to revenue growth during sales grew 58%, and our operating profit increased by 89%. We are also tightening our full-year revenue guidance to $380 to $390 million and lowered our operating expense guidance to 310 to 315 million. Both of our commercial products contributed to growth. Rukinest returned to growth in the quarter with U.S. demand back to prior year levels in volume terms. Joengia continued to grow strongly in the U.S. and internationally. That performance carried through to a significant increase in operating profit and strong operating cash flow. Leverne will take you through each product shortly, and I'll come back to the full financials and our guidance later in the course. At the start of the second half, we laid out three goals for 2026, and I'm happy to report that we made notable progress on each of these during the quarter. First, RUCANEST, which stabilized demand and returned revenue to growth in the quarter ahead of our own projections and furthermore saw stabilization in underlying demand. Second, Joenja and APDS, geographic and pediatric expansion continued. We launched in Germany in July and Japan in August, with Japan becoming the first market where Joenja is commercially available for children aged 4 to 11. In the U.S., the FDA approved our pediatric label expansion on September 11th, ahead of the PDUFA date, and shipments for this newest market segment began this month. Third, advancing linealysib in conditions beyond APDS. On October 14th, we presented positive Phase II top-line data in genetic PIDs with immune dysregulation. and we expect to report top-line data from our CVID study in November. These updates represent substantial growth for Lineolisib in the years ahead. With that, I'll hand the call over to Leverne to discuss our commercial performance. Leverne.

Thank you, Kenneth. Good morning, good afternoon, everyone. I'll provide an update on our third quarter commercial performance. and the growth opportunities ahead for Rukinest and Joenja. Starting with Rukinest, the third quarter marked a return to revenue growth for Rukinest. As you heard from Kenneth, Rukinest revenue reached $93.8 million, an increase of 14% year over year. Importantly, We have stabilized underlying U.S. demand with volume returning to prior year levels. This compares favorably to declines we reported in Q1 and Q2 and we expect this positive trend in demand to continue into Q4. We're encouraged by the stabilization that came only one year after the introduction of the first oral on-demand treatment. And as we communicated previously, RUCNES demand has not been impacted by any new prophylaxis treatments that were launched in 2025. We continue to maintain the overwhelming majority of our active patient base with particularly strong retention amongst patients experiencing more frequent or severe HAE attacks. And we continue to attract new patients and new prescribers. To put our revenue performance into context, though, there's one additional factor worth highlighting. Rukines' third quarter revenue benefited from a seasonal increase in channel inventory that came a quarter earlier than expected. This contributed approximately nine percentage points of the quarter's 14% year-over-year growth. While these inventory levels can fluctuate, The underlying patient demand remains our most meaningful indicator of the franchise performance. And so the stabilization that we've seen in Rukines demand reinforces our confidence in its resilient and differentiated position within the HAE treatment landscape. While treatment options are expanding choices for patients, we know that HAE is not a one-size-fits-all disease. Patients who are experiencing more frequent or more severe attacks often have very distinct treatment needs, and Rucanus continues to play an important role for this population. By replacing deficient or dysfunctional C1 esterase inhibitor, Rucanus targets the root cause of HAE across all pathways, offering high efficacy and a fast, complete resolution of attacks. We believe that these attributes are particularly important for patients with a higher disease burden and helps explain the strong patient retention that we've seen. More than a year after the launch of the first oral on-demand competitor, the overwhelming majority of ruchiness patients have remained on therapy and physicians continue to prescribe ruchiness for new patients with more severe disease. In addition, RUCNES' highly specialized manufacturing process may present challenges for direct biosimilar competition, and these factors combined further support our confidence in its long-term commercial position. Now, turning to Joendra. We continue to build on our commercial momentum in the third quarter, with global revenue increasing 58% year-over-year to $23.8 million. This is driven by continued U.S. patient growth and an increased contribution from international markets. In the U.S., revenue increased 19% to $15.9 million, supported by continued growth in patients on therapy. We ended the quarter with 136 U.S. patients on paid therapy, up 17% year over year, also an increase of four patients from the end of the second quarter. Internationally, our revenue increase is $7.9 million compared to $1.7 million a year ago. And right now, the international business represents approximately one-third of Joendra's global revenue. This growth reflects our expanding international presence, including launches in Germany and Japan, alongside continued penetration in the UK. At quarter end, 75 patients were receiving paid therapy internationally, including 50 patients in launch markets and 45 patients through paid access programs in other markets. It's worth noting that international revenue for Joengia also benefited from ordering patterns in certain markets that we consider temporary. As a result, there is a $2 to $3 million in earlier revenue recognition that benefited Q3 that we originally expected in Q4. Importantly, the growing number of patients receiving treatment across markets demonstrates continued progress in expanding Joandra's global commercial reach. And additionally, our third quarter results do not yet reflect any revenue contribution from the newly approved U.S. pediatric doses which began shipping in October. This brings me to our next slide. A notable next phase of Joenger's U.S. growth is now underway, following FDA approval of the new pediatric doses in September. This approval expands access to Joenger for eligible children aged 4 to 11, an important population that was previously outside of the approved age range. On September 11th, as Kenneth mentioned, the FDA approved our supplemental new drug application for the 40 and 50 milligram twice daily doses for children, age four to 11, weighing at least 27 kilograms. This happened ahead of the anticipated October 24th Biduva date. Our shipments began in October, marking a significant milestone in our efforts to expand treatment across younger patients with APDS. We're also pursuing further expansion of our pediatric label and in July we submitted a separate supplemental application for the lower doses for children aged 4 to 11 between 13 and less than 27 kilograms. The FDA has accepted the application with priority review and we have an assigned PDUFA date of January 30th, 2027. To date, we've identified over 60 children aged 4 to 11 with APDS in the United States. The newly approved doses address 38 of these patients, with remaining children potentially becoming eligible under the lower dose application if approved. We've seen a strong start to the pediatric launch in the U.S., and we are expecting an initial bolus of new patients on therapy throughout Q4. in the range of 15 to 20 patients on therapy. And we look forward to providing an update on patients receiving treatment when we report our full year results early in 2027. Looking ahead, we see several growth drivers that can build on Joenger's established commercial foundation in APDS. In the U.S., we expect continued patient finding, increased genetic testing, and expanded treatment access for younger pediatric patients. As of September 30th, we had identified 304 patients with APDS in the United States and 1,056 globally, reflecting continued progress in identifying individuals living with this rare disease. Internationally, our focused geographic expansion can result in a doubling of the addressable APDS opportunity. is now approved in all our target launch markets with Germany launching in July, Japan in August, building on our established presence in the UK. Beyond APDS, our clinical development programs are exploring lamiolisis potential in significantly larger populations of patients with immune dysregulation. For common variable immune deficiency or CVID with immune dysregulation, where we plan to pursue a registrational trial, there are more than 13,000 patients in the United States, a 26 times prevalence compared to APDS. Anurag will review our clinical programs with Leniolisib in just a few minutes. While this remains investigational, it certainly represents a potentially significant expansion of Joenger's addressable opportunity. And together, These growth drivers provide a clear path to build on Joendra's existing commercial foundation with continued expansion in APDS to the potential treatment of substantially larger patient populations in CVID. Our ambition is to establish Joendra as a broader immunology franchise with blockbuster potential. And with that, I'll turn the call over to Anurag to discuss our clinical development programs.