Release Date: August 04, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Record FILSPARI demand with over 2,000 new patient start forms across IgA nephropathy and FSGS, and record US revenue of more than $141 million for the quarter.
- Successful early adoption of FILSPARI in FSGS exceeded high expectations, with all fundamentals regarding demand, payer access, fulfillment, and revenue exceeding metrics seen during the initial phase of the IgA nephropathy launch.
- Continued growth in IgA nephropathy demand despite additional market entrants, reinforcing FILSPARI's established and differentiated positioning as the most widely utilized treatment option approved for the condition.
- The USPTO issued a Notice of Allowance for a US patent application directed to certain methods of using sparsentan in IgA nephropathy, providing additional US patent coverage upon issuance.
- Closed an exclusive licensing agreement with Everest Medicines for civorebrutinib, adding a differentiated upstream immune modulating approach to the rare kidney disease portfolio with potential application across multiple immune-mediated kidney diseases.
- Strengthened the balance sheet through successful convertible note transactions, ending the quarter with approximately $489.2 million in cash, cash equivalents, and marketable securities.
- Pegtibatinase Phase III HARMONY study enrollment is continuing, with top line results expected in the second half of 2027, positioning it as a potential first and only disease-modifying therapy for classical homocystinuria.
Negative Points
- Gross-to-net discounts for FILSPARI are expected to be slightly higher in the third and fourth quarters due to more FSGS patients initiating therapy with higher CMS utilization.
- The company recognized a $40 million inducement expense related to the repurchases of 2029 convertible notes during the quarter, impacting total other expense net.
- It is still early in the FSGS launch, and the company cautions against extrapolating from a single quarter, with potential seasonal impact during the summer months expected to cause some quarter-to-quarter variability in patient starts.
- The company paid a $112.5 million upfront amount to Everest Medicines following the close of the civorebrutinib transaction, which is a significant cash outflow.
- There is ongoing uncertainty regarding payer pushback on combining FILSPARI with other branded agents like APRIL inhibitors, as physicians express angst about using multiple therapies to achieve treatment targets.
- The company has not yet provided an update on the FSGS method of use patent, with patent prosecution still ongoing and no specific timeline for resolution.
Q & A Highlights
Q: Can you help us understand how much of the upside in the record 2,000+ patient start forms (PSFs) was driven by stronger-than-expected FSGS uptake versus continued acceleration of the IgA nephropathy launch?
A: Eric Dube (CEO) confirmed that demand for IgA nephropathy grew quarter-over-quarter despite new market entrants, reinforcing FILSPARI's established positioning. Peter Heerma (CCO) added that FILSPARI remains the most utilized treatment option approved for IgA nephropathy, and the FSGS launch was highly anticipated, with strong physician and patient enthusiasm driving rapid early adoption.
Q: Regarding the FSGS launch, what are you seeing on timelines from start form to paid script, and how do you expect this to evolve?
A: Peter Heerma (CCO) stated that conversion from patient start forms to paid prescriptions is faster in FSGS than it was initially in IgA nephropathy, as expected. However, it still takes time to educate payers and get FILSPARI included in formularies. While ahead of the IgA nephropathy launch pace, there is still work to be done, but the team is pleased with the progress and continues to educate payers on the label and health economic evidence.
Q: For FSGS, where is the demand coming from in terms of prescribers and patients? Are there notable patterns among academic centers, community nephrologists, or prior DUPLEX investigators?
A: Eric Dube (CEO) highlighted the breadth of prescribing as the most striking learning, with physicians trying the drug but still having room to deepen prescribing. Peter Heerma (CCO) added that about 70% of FSGS prescribers had prior experience with FILSPARI in IgA nephropathy, while 30% are new to the brand, creating a potential halo effect. Early patients tend to have high proteinuria levels, but the broad prescriber base with most physicians having only a single patient supports confidence in continued demand.
Q: How do you expect persistency in FSGS to track relative to IgAN, and can you quantify any bolus or pent-up demand seen in the early launch?
A: Eric Dube (CEO) clarified that the company did not see evidence of a bolus, but rather rapid uptake based on high anticipation of the approval. Peter Heerma (CCO) noted it is too early to assess persistency differences, but compliance rates in IgA nephropathy are high, and early FSGS data shows similar up-titration behavior from 400mg to 800mg consistent with the label.
Q: You noted conversion rates are exceeding what you saw in IgAN previously. What was the rate with IgAN, and are you being too conservative in modeling 70% conversion?
A: Peter Heerma (CCO) did not disclose specific rates but explained that the established patient services team, experience with the REMS process, and FILSPARI's existing formulary presence have resulted in higher conversion rates in FSGS than early IgA nephropathy. Eric Dube (CEO) added that from near day one of the FSGS launch, the company is in a much stronger position than when starting with IgA nephropathy, aligning to a very strong outlook.
Q: Has the strong FSGS launch changed your confidence in the prior estimate of the $3 billion peak sales opportunity for FILSPARI across IgAN and FSGS?
A: Eric Dube (CEO) reaffirmed confidence in the revenue opportunity exceeding $3 billion at peak across both indications. He noted the company is only scratching the surface of the addressable FSGS patient population, and while other therapies are in development, they are seen as complementary rather than competitive, with combination therapy likely to emerge as a standard approach.
Q: Otsuka disclosed that approximately 50% of VOYXACT's prescriptions are switches. Do you have patient-level switch data quantifying outflows in 2Q?
A: Peter Heerma (CCO) stated that the company has not disclosed whether prescriptions are new or switches, but most FILSPARI prescriptions are new to branded therapies. This is consistent with the positioning of FILSPARI as the first change physicians make, moving from generic RAS inhibition to FILSPARI before considering other branded modalities.
Q: Last quarter, you mentioned the "without nephrotic syndrome" language would be an education opportunity rather than a barrier. Has this held true?
A: Peter Heerma (CCO) confirmed that physicians understand the indication well, as it is consistent with how they practice nephrology in FSGS and aligns with KDIGO guidelines. While there is still education to be done, physicians understand the positioning for patients not currently in nephrotic syndrome, and no unexpected issues have been encountered.
Q: Regarding civorebrutinib, what could be the potential outcome in membranous nephropathy with the PARASOL group, and could there be a faster path to pivotal development?
A: Jula Inrig (CMO) stated the company is excited by efforts to define endpoints to accelerate therapies for high unmet need. The standard development strategy in membranous nephropathy is looking at complete remission over 2 years, but there is interest in shorter durations or biomarkers. Any acceleration will require data analysis and alignment with regulatory agencies, and the company will align its development strategy with available data.
Q: Following the restart of HARMONY enrollment, what gives you confidence in maintaining the 2H '27 top line timeline, and how should we think about enrollment momentum?
A: Jula Inrig (CMO) did not provide specific enrollment targets but cited progress to date, patient identification work over the last couple of years, continued execution of clinical operations teams, and engagement with the patient community and sites as reasons for confidence in the second half of 2027 top line data timeline.
Q: What clinical or practical experience do physicians need before prescribing FILSPARI more broadly across their eligible FSGS patients, and when should we see breadth translate into depth?
A: Peter Heerma (CCO) explained that it is early in the launch, and consistent with previous launches, physicians initially prescribe to specific patients they have in mind. After seeing positive experiences, they are encouraged to prescribe more. The company expects depth of prescription to increase quickly, given the broad prescriber base and the majority of physicians having only a single patient so far.
Q: Is there any update on the FSGS method of use patent or extension of
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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