Kiniksa (KNSA) Q1 FY26 earnings call: guidance and Q&A

What early demand signals are you seeing from the new DTC campaign, and what other plans are in place to accelerate demand for ARCALYST?

Ross Moat stated it's early days for the targeted DTC campaign, which uses AI to reach potential recurrent pericarditis patients and empower them to speak with HCPs, addressing the 14% unaided awareness. He highlighted a multi-faceted approach including continued commercial execution, broader digital marketing, and peer-to-peer education to drive growth.

“So we know that there's a big awareness gap out there with patients. We know patients are very widely dispersed across the country. So this is our approach of ours of going out, trying to identify those patients and serve up appropriate, very targeted, very tailored messages that can help appropriate patients to be empowered to go and speak to their healthcare professionals about ARCALYST.”

asked by Nicholas Lorusso · answered by Ross Moat

Which endpoints from the KPL-387 Phase II study are most critical for selecting the optimal dose for Phase III?

John Paolini explained that the Phase II study aims to define the PK/PD relationship by assessing the cadence and magnitude of onset of action (suppression of pain and inflammation via C-reactive protein) and the duration of action across four dose levels. These three elements will be integrated to affirm the therapeutic concentration and the dose for Phase III.

“And then from that, we integrate all three of those elements to build the PK/PD relationship and affirm the -- what we believe to be the therapeutic concentration as well as the dose level that we would carry forward into Phase III. So it's really the integration of those three critical elements.”

asked by Anupam Rama · answered by John Paolini

Is the DTC component the sole driver of increased SG&A? Why is the KPL-387 transition study 16 weeks, differing from prior rilonacept studies?

Mark Ragosa stated SG&A growth was due to personnel and sales/marketing, including DTC, but SG&A as a percentage of sales has been consistent. John Paolini clarified that the 16-week duration for the KPL-387 transition study is appropriate for moving well-controlled patients from various prior therapies to KPL-387 monotherapy, aiming for steady state by week 16, followed by a long-term extension.

“This study is really designed to look at well-controlled patients as they move from their prior therapies to KPL-387. And in this study, patients are transitioning from regimens of NSAIDs and colchicine from corticosteroids and IL-1 pathway inhibitors, including anakinra and rilonacept.”

asked by David Nierengarten · answered by Mark Ragosa

Beyond awareness and physician adoption, what impact have reimbursement and referral patterns had on new patient starts for ARCALYST?

Ross Moat confirmed that reimbursement remains very strong across all payer mixes. He noted that while there are some centers of excellence, recurrent pericarditis patients are broadly dispersed, necessitating broad education efforts. The broad label and strong coverage support the significant opportunity, with the DTC campaign empowering patients to drive awareness.

“The reimbursement continues to be very strong across all the different payer mixes, and that's both for new patients coming on as well as the revalidation of the scripts usually after a one-year time period. So that continues to really be very positive.”

asked by Edward Nash · answered by Ross Moat

Is the Q1 co-payment dynamic a one-off or structurally favorable? Does the KPL-387 transition study imply confidence in the Phase III dose?

Mark Ragosa stated co-pay support will be favorable to gross-to-net annually, with most impact in Q1, and expects a return to historical seasonal patterns. Ross Moat detailed enhancements to the co-pay program, reducing average payouts. John Paolini noted that the KPL-387 transition study design (details in clinicaltrials.gov) does not yet include specific dose level information, and more will be shared later.

“So we will have more to say at a later date about the design of the study.”

asked by Kyuwon Choi · answered by John Paolini

Is there a tipping point for adding more patients in the first recurrence segment for ARCALYST? How does Kiniksa plan to maximize value with positive cash flow, particularly regarding BD opportunities before KPL-387 Phase III?

Ross Moat noted 20% of current ARCALYST prescriptions are in the first recurrence group, growing over time, supported by ACC guidance. Sanj Patel emphasized focus on KPL-387 Phase II/III and KPL-1161 Phase I, while continually evaluating BD opportunities with a high bar, balancing internal value creation with external growth.

“Clearly, we're very much focused on capturing further growth with ARCALYST very important continued effort for us. But then as we said, 1161 also should enter the clinic this year. So a number of milestones for us. And we balance all that consistently looking at how there are other ways to create value.”

asked by Geoffrey Meacham · answered by Sanj Patel