Aug 19, 2026 earnings call — Pixclara PDUFA and BiPASS trial progress
Company reported revenue of $477 million for H1 2026, up 22% year-on-year.
Revenue $0.5B (est $0.5B) · EPS $0.11 (est $0.04) · Next-quarter revenue outlook $0.9B–$1.0B
Key quotes
"In the second quarter, we delivered $202 million in revenue, up 9% quarter-over-quarter, following $186 million in the first quarter, which was up 16% quarter-over-quarter."
"On the regulatory front, we've completed the submissions for Pixclara and Pixlumi in both the U.S. and Europe, with a PDUFA date now assigned in the U.S. of the 11th of September."
"But what pleasantly surprised us was the site in Melbourne almost had the study done and dusted by itself."
Analyst Q&A 7
TruVu impact and Zircaix resubmission
Q (Chris Cooper · JPMorgan): Asked how TruVu reimbursement (effective Oct 1) will affect market share for PSMA imaging for the rest of the year. Also asked about timing and control of the Zircaix resubmission and whether it will happen in the next month or two.
A: Management said they do not expect TruVu to have a large market impact because it is positioned as a manufacturing improvement and must be rolled out across all market segments; they have not changed their guidance. For Zircaix, management said resubmission timing is fully within their control and a resubmission in the next month or two would be a reasonable assumption.
"Our guidance bakes in what we think is going to be the realistic outcome for the year and, and really nothing has changed from our perspective." — Christian Behrenbruch (CEO)
BiPASS powering and Zircaix extension
Q (Laura Sutcliffe · Citi): Asked why BiPASS target recruitment was increased and whether that was due to statistical powering needs. Also asked if the FDA extension for Zircaix has any deadlines or is connected to the corrective CRL.
A: Management said the increase was not simply a statistical plan issue but driven by trial dynamics: rapid uptake and a backlog of patients that they elected to fulfill. They added the FDA dialogue was collaborative, and said the Zircaix extension was unconnected to the delayed CRL and did not impose restrictions on resubmission timing.
"So because of the backlog of patients that we had in the study, we actually elected to fulfill the backlog." — Christian Behrenbruch (CEO)
Antibody modality debate and competitor merger
Q (Tsan-Yu Hsieh · William Blair): Asked for a response to negative views presented about antibody modalities at ASCO and whether the Lantheus–Curium merger changes their strategy.
A: Management said data matters and rebuttals were voiced at ASCO; they remain modality agnostic and will present more detail at their R&D Day. Regarding the competitor merger, they said it is business as usual and they will continue their current plans.
"At the end of the day, what we care about is what's the pharmacology of the drug, how does it interact with the target, how does it deliver a payload." — Christian Behrenbruch (CEO)
Physician reaction and BiPASS success measures
Q (David Low · UBS): Asked for early feedback from physicians on BiPASS and what successful outcomes will look like for the study.
A: Management said enrollment was rapid and that investigators showed strong enthusiasm, with a Melbourne site enrolling a large portion quickly. They said physicians want gallium PSMA PET added to MRI because it gives more useful information for biopsy decisions and treatment planning, and that early rapid enrollment signals positive investigator views of clinical performance.
"But what that showed was that there's a very -- there's clearly a very significant physician desire to add the benefits of gallium PSMA PET imaging on top of MRI imaging." — David Cade
Pixlumi regulatory timeline
Q (David Stanton · Jefferies): Asked for an update on timelines for the Pixlumi marketing authorization decision and when a decision might be expected.
A: Management said they have not given updated timelines because early review can lead to clock stops, so it's watch-and-wait. They noted the formal review from submission is around an 18-month process, but timing can vary and they do not expect major issues with the package.
"If you follow the review time line to the letter from submission, it's around an 18-month process." — Christian Behrenbruch (CEO)
ProstACT IND and revenue guidance
Q (Melissa Benson · Barrenjoey): Asked whether the IND amendment for ProstACT Part 2 has been filed and if U.S. sites are on track this half; also asked about European CTA progress. Separately asked why revenue guidance was not raised despite strong PSMA PET performance.
A: Management said after one more FDA engagement in a couple of weeks they will file the IND amendment to start Part 2 and that U.S. patient enrollment this year is the priority; European sites will be added after the U.S. submission. On revenue, they stated they have given guidance and are maintaining it.
"So we have one more engagement coming up with the FDA in a couple of weeks' time, and then we'll be filing the IND on the back of that." — Christian Behrenbruch (CEO)
BiPASS label and TLX597 next steps
Q (Dennis Hulme · Taylor Collison): If BiPASS results are positive, what label claim do they expect and how would use be targeted across PI-RADS scores, especially PI-RADS 3 or less? Also asked next steps for TLX597 after ongoing trials.
A: Management said they do not give label guidance until negotiated with regulators but the study's intent is to guide biopsy decision-making. They said the FDA agreed the trial would enroll PI-RADS 1–4 (not 5) and the goal is to halve biopsies while not missing clinically significant cancers; on TLX597, they are awaiting initial Phase II data and will complete recruitment of their flagship 591 program before deciding next steps.
"So we agreed with the FDA that it would enroll PI-RADS 1, 2, 3 and 4, but not 5." — David Cade