Highlights

  • Pacific Edge posts net loss of USD 19.1M for H1 FY26 following Medicare coverage lapse.
  • Total laboratory throughput of Cxbladder tests declines 10% compared to 2H FY25.
  • CMS sets draft Triage Plus price at USD 1,328, expanding potential global market.

Pacific Edge (NZX:PEB) recorded operating revenue of USD 5.9M for the six months to 30 September 2025 (1H FY26), down from USD 10.9M in 2H FY25, following the loss of Medicare coverage. Total revenue declined to USD 7.1M from USD 12.5M. Revenue from Medicare-related tests cannot be recognized until successfully appealed, a process expected to take 6–9 months.

Laboratory Throughput and Commercial Activity
Total laboratory throughput (TLT) for Cxbladder tests was 13,191, down 10.1% from 2H FY25, while commercial test volumes fell 15.9% to 10,371 tests. US test sales per FTE reached 403 for Q2 FY26, an increase of 5.8% on Q1 FY26 after sales force reductions and focus on profitable territories. Asia Pacific (APAC) TLT increased 5.4%, reflecting non-billable tests and clinical study volumes.

Costs and Cash Position
Total operating expenses decreased 5.9% on 2H FY25, with net cash flow from operating activities at USD 19.0M, up from USD 12.3M. Cash and cash equivalents, including short-term deposits, stood at USD 22.1M, supported by a USD 20.7M capital raise in August 2025. Strategic options are being considered given the extended Medicare re-coverage timeline and appeals delays.

Strategic and Clinical Developments
Pacific Edge continues to progress its evidence portfolio for Cxbladder Triage and Triage Plus. Key publications include the Analytical Validation of Triage Plus (Harvey et al. 2025) and Clinical Validation (Savage et al. 2025; DRIVE Study). A new Kaiser Permanente study on real-world clinical utility is expected ahead of the Contractor Advisory Committee (CAC) convened by Novitas on 19 February 2026.

CMS has set a draft Triage Plus price of USD 1,328, up from USD 760 for existing products. The change increases the company’s global addressable market to USD 10.8B. Pacific Edge continues to appeal non-reimbursed Medicare claims and expects recognition only after hearings with an Administrative Law Judge.

Outlook
Revenue is expected to rise in 2H FY26 following successful Medicare appeals, although timing is subject to ALJ scheduling. Non-Medicare revenue streams remain under management focus, including Kaiser Permanente and other commercial payers.

Share Price Snapshot

PEB was trading at NZD 0.166 per share as of 25 November 2025.