Verici Dx reports record Tutivia orders, downgrades revenue outlook

(Sharecast News) - Verici Dx has reported its highest-ever quarterly order rate for its Tutivia transplant diagnostic test in an update on Monday, with 292 orders in the first quarter of 2025, representing a 68% increase over the prior quarter, although it revised down its revenue forecasts amid some market delays. The AIM-traded company highlighted the figure as a strong signal of early adoption, particularly notable as it preceded a decision on Medicare reimbursement coverage.

Revenue recognition for Tutivia remained contingent on a pending decision from Medicare contractor MolDX.

The price per test under Medicare was set at $2,650, and the company said it expected an outcome on the technical assessment shortly.

Verici said it was continuing to engage with 19 leading US transplant centres, where Tutivia was being embedded into clinical pathways, as it reported encouraging levels of repeat orders.

The firm also confirmed the achievement of a $0.75m milestone under its commercial agreement with Thermo Fisher Scientific for the PTRA assay.

It said the payment was invoiced in the first quarter, and was expected to be received in the second.

Cash as at 31 March stood at $1.63m, and with ongoing cost controls, the company said it expected sufficient runway through to the end of June, subject to receipt of the milestone.

It said its partnership with Thermo Fisher remained active, with further research underway to expand the utility of PTRA to earlier stages of transplant care.

However, that had delayed the second milestone payment originally expected in 2025.

The company also noted that full-year 2024 revenue would now be reported at $3.3m, following the deferral of that milestone payment, with an adjusted EBITDA loss of $5.4m, in line with expectations.

Due to market uncertainty and a more conservative approach to forecasting, Verici said it was revising down its 2025 revenue expectations for the services division from $5.9m to $0.5m.

Licensing and product development timelines for Protega and a urine-based test had meanwhile been extended to the end of 2025.

Verici said it was focussed on raising industry awareness through active participation in major first quarter transplant conferences, including CEoT, NATCO, and the ASTS Winter Symposium, which it said helped increase visibility of both Tutivia and PTRA among key clinical audiences.

"I am extremely proud of the progress we have made since our last update, particularly when viewed in the context of limited resources and, ahead of the local coverage determination for Tutivia," said chief executive officer Sara Barrington.

"The significant increase in orders for Tutivia in the last quarter reflects how it directly addresses areas of unmet need in transplant, as well as general utility, and demonstrates it is being very well received by clinicians who are passionate about improving their patient outcomes.

"Verici has proven to lead the way in developing a new wave of technology for transplant with both Tutivia and PTRA being clinically launched, and there is a high degree of interest in the progress in our other programs which have the potential to add significantly to the field."

Barrington noted that the company had previously said that adoption of innovative products was sensitive to establishing comprehensive insurance coverage, adding that it recognised that the lack of coverage through 2024 slowed the pace of adoption.

"That said, we are pleased with the initial Tutivia test ordering, the levels of repeat ordering, and we still expect volumes to further accelerate as insurance coverage is established."

At 1103 BST, shares in Verici Dx were down 46.15% at 1.75p.

Reporting by Josh White for Sharecast.com.