Pacific Edge Release Quarterly Volumes for Q2 FY25

PACIFIC EDGE RELEASES QUARTERLY VOLUMES FOR Q2 FY25

Cxbladder test volumes slightly down; Kaiser Permanente and APAC volumes up; US sales force efficiency gains sustained

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today announces tests processed at its laboratories in the three months to the end of September 2024 (Q2 25) were slightly lower on the prior quarter (Q1 25).

As detailed in the Q2 25 investor update released today, the Centers for Medicare & Medicaid Services (CMS)’ July 2024 decision to grant an extension to Novitas, our Medicare Administrative Contractor, on its deliberations over Medicare coverage of our tests and the uncertainty associated with the extension added to the challenges faced by the sales team.

However, continuing strong demand from our US customer Kaiser Permanente, the sustained benefits of our sales force efficiency gains and a lift in volume in the APAC region diluted the impact of these factors.

The investor update also provides detail on the catalysts for positive progress in the coming months including:

• The American Urological Association’s review of its microhematuria guideline, and the review’s potential to recognize the clinical and economic value of urine biomarkers such as Cxbladder and drive changes in clinical practice and the medical and reimbursement policies of healthcare payers, including Medicare.
• A study by the Southern California Permanente Medical Group, whose preliminary data demonstrates the clinical utility of Cxbladder Triage, and advances in our clinical evidence program, could provide for clinical practice and payer reimbursement policy change.
• Our approach to achieving a CMS price for Detect+ that recognizes its clinical and economic value in the evaluation of hematuria and our strategy (and required antecedents) for the commercial launch of the test in 2025.

Total laboratory throughput (TLT) in Q2 25 fell 2.0% to 7,045 tests, a figure slightly down on the 7,188 tests in Q1 25. US TLT was 5,682 tests down 3.8% on the 5,905 in Q1 25. The average US sales force was steady at 15 FTE against Q1 25.

The sales force efficiency metric fell to 379 tests per sales FTE down from 403 in the prior quarter, consistent with the lower US volumes. Tests per unique ordering clinician (our preferred metric for measuring customer commitment to Cxbladder) was down slightly to 6.4 in Q2 25 from 6.8 in Q1 25 reflecting the lower volume (ordering clinicians were slightly higher at 890).

Asia Pacific volumes were up 6.2% to 1,363 tests from 1,283 in Q1 25 reflecting a lift in volume in New Zealand and growing, albeit still small volumes, from Australia and our distributors in Asia.

Group total test volumes for the half year (1H 25) were down 22% to 14,233 from 18,240 in 1H 24, the period just ahead of Pacific Edge undertaking a reorganization to reduce the size of the sales team to preserve cash to weather the Medicare uncertainty.

Released for an on behalf of Pacific Edge by Grant Gibson, Chief Financial Officer.

For more information:

Investors:
Dr Peter Meintjes
Chief Executive
Pacific Edge
P: +64 22 032 1263

Media:
Richard Inder
The Project
P: +64 21 645 643

OVERVIEW
Pacific Edge: www.pacificedgedx.com
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way in the development and commercialization of bladder cancer diagnostic and prognostic tests for patients presenting with hematuria or surveillance of recurrent disease. Headquartered in Dunedin, New Zealand, the company provides its suite of Cxbladder tests globally through its wholly owned, and CLIA certified, laboratories in New Zealand and the USA.

Cxbladder: www.cxbladder.com
Cxbladder is a urine-based genomic biomarker test optimized for the detection and surveillance of bladder cancer. The Cxbladder evidence portfolio developed over the past 14 years includes more than 20 peer reviewed publications for primary detection, surveillance, adjudication of atypical urine cytology and equivocal cystoscopy. Cxbladder is the focal point of numerous ongoing and planned clinical studies to generate an ever-increasing body of clinical utility evidence supporting adoption and use in the clinic to improve patient health outcomes.

Cxbladder has been trusted by over 4,400 US urologists in the diagnosis and management of more than 100,000 patients, including the option for in-home sample collection. In New Zealand, Cxbladder is accessible to 75% of the population via public healthcare and all residents have the option of buying the test online.

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Announcement PDF