Latest news with #TriagePlus
Scoop
3 days ago
- Business
- Scoop
Pacific Edge Reports Resilient Performance In FY25
Press Release – Pacific Edge Pacific Edge also announces a NZ$20 million equity raising to capitalize on recent clinical and commercial milestones, grow in non-Medicare channels and regain Medicare coverage. The details of the capital raising are covered in a separate announcement … AUDITED FINANCIAL RESULTS FOR THE YEAR TO 31 MARCH 2025 30 May 2025 Pacific Edge today reports a resilient financial result for the year to the end of March 2025. Improvements in the performance of the sales force, operating efficiencies and cash collection gains over the financial year have positioned the company well as it works towards regaining Medicare coverage of its tests. Pacific Edge today also announces a NZ$20 million equity raising to capitalize on recent clinical and commercial milestones, grow in non-Medicare channels and regain Medicare coverage. The details of the capital raising are covered in a separate announcement to the NZX and ASX today. FY25 FINANCIAL PERFORMANCE2 Operating revenue down 8.6% on FY 24 to $21.8 million, reflecting Medicare uncertainty. Total revenue is down 16% on FY 24 to $24.6 million Total laboratory throughput3 (TLT) of Cxbladder tests fell 11.5% on FY 24 to 28,894; commercial tests fell 9.9% on FY 24 to 26,42 tests Tests/Sales FTE in the US for Q4 25 were reported at 405.6, up 6.4% on Q4 24; ASP4 for all commercial tests in the US increases to US$594 in FY 25 vs US$584 in FY 24 as operating efficiencies and cash collection gains continue to improve Strong performance from the Southern California Permanente Medical Group, increased APAC volume and sustained sales force efficiencies reduce the impact of Medicare uncertainty and the reduced sales team reach Net loss after tax +1.4% on FY 24 to $29.9 million, 2H 25 net loss +6.4% on 1H 25 led by increased expenditure on clinical research, Triage Plus commercialization and legal fees Cash, cash equivalents and short-term deposits of $22.6 million at the end of FY25; cash burn of $13.4 million in 2H 25 down 6.7% on 1H 25 FY 25 STRATEGIC PERFORMANCE Cxbladder Triage included in the American Urological Association (AUA) guidelines with a 'Grade A' evidence rating, the only biomarker to achieve this status Triage Plus achieves a draft Medicare price of US$1,018.44, a significant premium to the current US$760 per test; full scale commercial launch is now contingent on re-coverage Medicare coverage discontinued following Genetic Tests for Oncology (Specific Tests) (L39365) becoming effective after balance date (24 April 2025); Pacific Edge is now focused on regaining coverage for Triage and Monitor and obtaining coverage and launch of new products Triage Plus and Monitor Plus Commercial team focused on profitable territories, non-Medicare revenue streams and selling the clinical and economic value of Cxbladder; Cxbladder Detect discontinued FY25 Climate Disclosures released in compliance with NZCS NOTE: PEB HAS RELEASED THIS UPDATE TO THE NZX AND ASX AS PER LISTING RULES [1] 1 PEB has released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act. 2 All comparisons are to the same period of the prior financial year unless otherwise stated. 3 Total Laboratory Throughput (TLT) includes commercial, pre-commercial and clinical studies testing. 4 ASP: US Average Sales Price (US Operating Revenue in USD / US Commercial Test Volumes)
Scoop
4 days ago
- Business
- Scoop
Pacific Edge Reports Resilient Performance In FY25
AUDITED FINANCIAL RESULTS FOR THE YEAR TO 31 MARCH 2025 30 May 2025 Pacific Edge today reports a resilient financial result for the year to the end of March 2025. Improvements in the performance of the sales force, operating efficiencies and cash collection gains over the financial year have positioned the company well as it works towards regaining Medicare coverage of its tests. Pacific Edge today also announces a NZ$20 million equity raising to capitalize on recent clinical and commercial milestones, grow in non-Medicare channels and regain Medicare coverage. The details of the capital raising are covered in a separate announcement to the NZX and ASX today. FY25 FINANCIAL PERFORMANCE2 Operating revenue down 8.6% on FY 24 to $21.8 million, reflecting Medicare uncertainty. Total revenue is down 16% on FY 24 to $24.6 million Total laboratory throughput3 (TLT) of Cxbladder tests fell 11.5% on FY 24 to 28,894; commercial tests fell 9.9% on FY 24 to 26,42 tests Tests/Sales FTE in the US for Q4 25 were reported at 405.6, up 6.4% on Q4 24; ASP4 for all commercial tests in the US increases to US$594 in FY 25 vs US$584 in FY 24 as operating efficiencies and cash collection gains continue to improve Strong performance from the Southern California Permanente Medical Group, increased APAC volume and sustained sales force efficiencies reduce the impact of Medicare uncertainty and the reduced sales team reach Net loss after tax +1.4% on FY 24 to $29.9 million, 2H 25 net loss +6.4% on 1H 25 led by increased expenditure on clinical research, Triage Plus commercialization and legal fees Cash, cash equivalents and short-term deposits of $22.6 million at the end of FY25; cash burn of $13.4 million in 2H 25 down 6.7% on 1H 25 FY 25 STRATEGIC PERFORMANCE Cxbladder Triage included in the American Urological Association (AUA) guidelines with a 'Grade A' evidence rating, the only biomarker to achieve this status Triage Plus achieves a draft Medicare price of US$1,018.44, a significant premium to the current US$760 per test; full scale commercial launch is now contingent on re-coverage Medicare coverage discontinued following Genetic Tests for Oncology (Specific Tests) (L39365) becoming effective after balance date (24 April 2025); Pacific Edge is now focused on regaining coverage for Triage and Monitor and obtaining coverage and launch of new products Triage Plus and Monitor Plus Commercial team focused on profitable territories, non-Medicare revenue streams and selling the clinical and economic value of Cxbladder; Cxbladder Detect discontinued FY25 Climate Disclosures released in compliance with NZCS NOTE: PEB HAS RELEASED THIS UPDATE TO THE NZX AND ASX AS PER LISTING RULES [1] 1 PEB has released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act. 2 All comparisons are to the same period of the prior financial year unless otherwise stated. 3 Total Laboratory Throughput (TLT) includes commercial, pre-commercial and clinical studies testing. 4 ASP: US Average Sales Price (US Operating Revenue in USD / US Commercial Test Volumes)
National Business Review
29-04-2025
- Business
- National Business Review
Investors cheered by Pacific Edge news
An optimistic update from cancer diagnostics company Pacific Edge gave its shares a boost after a trading halt this morning interrupted investor gloom over bad news from the US. In a statement to the NZX, Pacific Edge said it had been notified its Triage Plus product could receive a price of US$1018
Scoop
29-04-2025
- Health
- Scoop
Triage Plus Price Set To Lift Pacific Edge's Economics
Pacific Edge notes today that the draft 'Gapfill' prices for Cxbladder Triage Plus2 have been published by the US Centers for Medicare & Medicaid Services (CMS) proposing a draft price for the test of US$1,018.44. When finalized, the CMS price for Triage Plus sets the amount Pacific Edge will be reimbursed for all patients with Medicare and Medicare Advantage insurance. This will be subject to Pacific Edge's Medicare Administrative Contractor (MAC), Novitas, providing coverage of the test. The test is currently listed as non-covered on Novitas' 'Genetic Testing in Oncology: Specific Tests (L39365)' Local Coverage Determination (LCD). Private health insurance companies make separate coverage and pricing decisions based on their own medical policy and contracting for a test. In the Gapfill process CMS asks each MAC to propose prices for any new testing services based on estimates of the resources needed to develop and run the test, then recommends the median of those prices as its final price. The seven MACs responsible for processing Medicare claims across various jurisdictions in the United States have published their draft pricing for Triage Plus. While Novitas priced Triage Plus at US$1,587.69, due to its agreements with multiple MACs, the price provided by MolDX3 is the de facto median price, because MolDX pricing is used in 28 of the 50 states. The draft pricing for MolDX was US$1,018.44, and subject to public comments that are due by 28 June 2025, and some possible adjustment based on those comments, CMS is expected to make that price effective on 1 January 2026. Hematuria evaluation tests currently represent around 81% of Pacific Edge's total US laboratory throughput4. The US$1,018.44 price is a meaningful increase compared to the US$760 CMS price of our existing tests, because it increases the margin and margin percentage per test and improves the profitability of operating our front-line sales force. When coverage of Triage Plus is established, Pacific Edge will make migration from Triage a priority, noting that Detect tests are being migrated to Triage tests effective immediately given the February 2025 inclusion of Triage in the American Urological Association's microhematuria guideline. Pacific Edge expects to submit a reconsideration request for coverage of Triage Plus as soon as the analytical validation (AV) and clinical validation (CV) studies have been published. The AV publication is being reviewed by the submitting authors and the CV publication, the DRIVE study5, has already been submitted for publication. Pacific Edge Chief Executive Dr Peter Meintjes said: 'We are very pleased that both MolDX and Novitas have recognized the novelty of Triage Plus in their pricing determinations with prices of US$1,018.44 and US$1,587.69 respectively. We have invested significant resources in Triage Plus – a multimodal test that combines DNA and RNA workflows with the outputs analyzed by a novel algorithm that provides dramatic performance improvement over existing tests and can be used on a broader patient population to assist clinicians to manage their hematuria patients as high, intermediate or low risk. 'The resources needed to develop, validate and operate Triage Plus commercially are substantial, thus necessitating a higher price, but importantly when Triage Plus' performance characteristics6 are used in our existing budget impact model7 we observe that the improved performance characteristics has the potential for even greater savings to the Medicare system by reducing more unnecessary procedures and allowing clinicians to spend more time and clinical resources on those who need it most.' Notes: 1 PEB has released the information contained in this update to the NZX and ASX as it regards it to be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act. 2 Cxbladder Triage Plus has CPT Code 0420U and has not yet completed the administrative name change from Cxbladder Detect+. 3 MolDX is a coverage and reimbursement program run by the Palmetto MAC that provides unique test registrations and technical assessments for molecular diagnostics products to which other MACs can subscribe. The majority of MACs have elected to do so, but Novitas and National Government Services do not. 4 Half year to 30 September 2024. 5 Detection and Risk stratification In Veterans presenting with hematuria: Savage S.J., et al (2025) The Prognostic Performance of Cxbladder Triage Plus for the Identification and Priority Evaluation of Veterans at Risk for Urothelial Carcinoma: The Drive Study, Abstract submitted to the AUA 2025 meeting. 6 Lotan Y, Raman JD, Konety B, Daneshmand S, Schroeck F, Shariat SF, Black P, de Lange M, Asroff S, Goldfischer E, Efros M, Chong KT, Huang E, Chua HL, Wu QH, Yeow S, Lau W, Yong J, Eng M. Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. J Urol. 2022 Dec 30:101097 JU0000000000003126. 7 Tyson MD, Abouassaly R, Durant A, Smith AB, Seemann K, Shoskes DA. Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients. Urol Pract. 2024 Jan;11(1):54-60. doi: 10.1097/UPJ.0000000000000489. Epub 2023 Nov 1. PMID: 37914255.
