NZ$13.6m Revenue And NZ$35.8m Loss Define FY26

Pacific Edge Limited (NZX:PEB) is betting that a pending US Medicare decision can reverse the damage from a sharp fall in reimbursement-driven revenue, after raising NZ$36.1 million to fund its next phase of commercial execution. The Dunedin diagnostics company says Novitas has issued positive draft coverage for its Cxbladder Triage and Triage Plus tests, with Triage Plus assigned draft pricing of US$1,328 per test.

Medicare decision remains the central catalyst

The proposed coverage applies to appropriately counselled intermediate-risk patients with microhematuria who are considering deferring cystoscopy. Pacific Edge says it expects Novitas to publish a final Local Coverage Determination by January 2027, although the presentation makes clear that the current position remains draft coverage rather than a settled reimbursement outcome.

That distinction matters. The company’s US strategy is built around converting eligible patients to Triage Plus, which it says combines sensitivity of 93.6%, specificity of 98.2%, a negative predictive value of 99.4% and a positive predictive value of 74.6% in the cited 2025 validation study. Those figures relate to the study and selected test cut-points, not to every patient population or future commercial result.

Revenue has not yet caught up with the opportunity

FY26 total revenue fell 44.8% to NZ$13.6 million, including NZ$11.5 million of operating revenue, while the net loss widened 19.5% to NZ$35.8 million. Cash receipts from customers dropped to NZ$13.2 million and operating cash outflow increased to NZ$31.9 million. Pacific Edge reduced operating expenses by 9.5% to NZ$49.4 million, but ended the year with NZ$7.8 million of net cash and an average monthly cash burn of NZ$2.9 million.

The May capital raising therefore provides time rather than proof of a turnaround. Pacific Edge says the proceeds strengthened its balance sheet as it pursues Medicare recapture, commercial payer adoption and product development. The company’s own modelling puts group profitability at roughly 55,000 tests a year, based on an annualised blended average selling price above NZ$1,450.

Volumes show a split between the US and APAC

US total laboratory throughput reached 4,973 tests in the March 2026 quarter, up from 4,025 in the June 2025 quarter, but commercial throughput was described as stable over the last three quarters. Pacific Edge has also reduced sales headcount to address cash burn and wants to shift the US product mix towards the higher-priced Triage Plus test once coverage permits.

APAC offers a steadier operating picture. Total quarterly throughput rose to 1,518 tests from 1,281 over the same comparison, with commercial volumes increasing for four consecutive quarters. The region contributed 19% of operating revenue in the second half of FY26, generated NZ$2.0 million for the full year and recorded a direct operating and clinical cash burn of NZ$0.17 million in the March 2026 quarter. Management says repricing in 2025 lifted revenue per test by an average 25%.

Surveillance Plus adds a longer-dated growth bet

Beyond hematuria evaluation, Pacific Edge is developing Surveillance Plus as a potential alternative to cystoscopy for monitoring recurrence in non-muscle invasive bladder cancer. The test remains in development, with clinical performance data not yet published in the presentation. The company is targeting a US CPT-PLA coding submission in June 2027 and claim-by-claim revenue from January 2028, while seeking a Medicare price of US$1,800.

The company also plans to simplify its next-generation tests into kitted in vitro diagnostic products for decentralised laboratory deployment outside the US. Those plans depend on budget approval, regulatory pathways and country-specific reimbursement, while several clinical studies scheduled through 2027 and 2028 remain important to the evidence case.

Cash runway now meets execution risk

Pacific Edge has a sizeable addressable-market narrative, including a company-estimated global opportunity of US$10.6 billion across the US, Europe and APAC. But the near-term investment question is narrower: whether draft Medicare coverage becomes final, whether clinicians actually order the higher-priced test, and whether resulting volumes can outrun the company’s cash consumption.