Latest news with #CxbladderTriage
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)
Otago Daily Times
4 days ago
- Business
- Otago Daily Times
‘Resilient' Pacific Edge announces capital raise
Cancer diagnostics company Pacific Edge has announced a $20 million capital raise in tandem with what it describes as a "resilient" full-year financial result. In a statement yesterday, the listed company said the equity raising was about ensuring it had the cash reserves to capitalise on recent clinical and commercial milestones, grow in non-Medicare channels and regain Medicare coverage of its tests. Total revenue was down 16% to $24.6 million while an after tax net loss of $29.9 million was up 1.4%. Total laboratory throughput of Cxbladder tests fell 11.5% on FY24 to 28,894 while commercial tests fell 9.9%. Medicare coverage discontinued in April and Pacific Edge was now focused on regaining coverage for its Triage and Monitor products and obtaining coverage and launch of new products Triage Plus and Monitor Plus. Chairman Chris Gallaher said while the adverse determination was a significant disappointment, it should not overshadow the major strategic progress made over the past year. Cxbladder Triage was included in the American Urological Association's new microhematuria guideline with a grade-A evidence rating, the only biomarker to receive that level of endorsement. With the US Centers for Medicare & Medicaid Services (CMS) announcing a draft price of US$1,018.44 for Cxbladder Triage Plus — a significant premium over the current US$760 price for Pacific Edge's existing tests — the company was positioned for "a rapid acceleration of revenue growth" in the United States once Medicare coverage was achieved, Mr Gallaher said. While confident it would regain coverage for Triage, the company said there were no guarantees as to the timing or outcome of the re-coverage process — it could be delayed or not achieved at all. Chief executive Dr Peter Meintjes said the AUA guideline cemented Pacific Edge's position as the market leader in non-invasive bladder cancer diagnostics. In combination with evidence not considered during the finalisation of the determination, the guideline put the company in a strong position to regain Medicare coverage for Cxbladder Triage. The capital raise comprised a placement of $NZ15 million of new ordinary shares to be offered to selected investors and an offer of $NZ5 million of new shares to retail investors, by way of a share-purchase plan. The share issue was priced at $NZ0.10 per share. Mr Gallaher said the new capital would support the company and its operations for over 12 months, giving Pacific Edge the ability to grow testing volume as it worked to regain coverage through planned Medicare reconsideration requests and challenging the non-coverage of Cxbladder Triage through the Medicare appeals process. All of Pacific Edge's directors and senior management intended to participate in the equity raising.
Scoop
28-04-2025
- Health
- Scoop
Medicare LCD Effective; Pacific Edge Seeks Recoverage
Press Release – Pacific Edge Pacific Edge filed for a preliminary injunction and undertook political advocacy efforts directed at the incoming political appointees within CMS2, HHS3 and OGC4 that included substantial support from the American Urological Association (AUA). Pacific Edge notes the 'Genetic Testing in Oncology: Specific Tests' (L39365) Local Coverage Determination became effective on 24 April 2025 in the US, halting Medicare coverage of Cxbladder tests. Pacific Edge filed for a preliminary injunction and undertook political advocacy efforts directed at the incoming political appointees within CMS2, HHS3 and OGC4 that included substantial support from the American Urological Association (AUA). However, on Wednesday 23 April 2025 a Pennsylvania District Court Judge ruled that her court lacks jurisdiction to hear Pacific Edge's claim against Medicare Administrative Contractor Novitas and CMS. Meanwhile, the lobbying efforts have not yielded a change to the effective date or retirement of the LCD. Pacific Edge, which currently generates ~60% of its US revenue from Medicare, will now focus on the paths available, which include Medicare appeals for Cxbladder Triage to get paid based on its inclusion in the AUA microhematuria guideline5, despite the non-coverage determination and reconsideration requests for Triage and Monitor. Pacific Edge submitted a reconsideration request for Cxbladder Triage under 'Biomarkers for Oncology' LCD (L35396) on 21 March 2025, a request that has already been deemed valid by Novitas, meaning they will now assess the evidence submitted. It also expects to submit a reconsideration request for Cxbladder Monitor under 'Genetic Testing in Oncology: Specific Tests' (L39365) as soon as possible and request non-coverage to be removed. However, Pacific Edge will not seek re-coverage of Cxbladder Detect as no new evidence has been published that can be submitted for reconsideration. Detect users will be required to move over to Triage in an acceleration of a plan intended to coincide with the commercial launch of Triage Plus. Novitas controls the timeline for these reconsideration requests and is not bound by any maximum period to complete this work. Industry experts typically estimate the time at 6-9 months for a valid submission of a single product with only a small number of new supporting publications and not the protracted period of consultation that results from creating a new LCD as was done with L39365. Regarding Cxbladder Triage Plus, the company will continue to develop, publish and subsequently submit a reconsideration request in line with our previously published roadmap – those activities remain on track. The company will also continue to work with Kaiser Permanente on a peer-reviewed publication confirming the real-world utility of Cxbladder Triage. The preliminary data was presented as a poster at the AUA 2025 annual meeting (April 26–29) in Las Vegas and will be used for future reconsideration requests when published. While the impact of 'Genetic Testing for Oncology: Specific Tests' (L39365) is expected to have a significant impact on testing volume, Pacific Edge expects to continue to bill and receive reimbursement from contracted commercial US payers without interruption, notably Kaiser Permanente, the US Veterans Administration, various Blue Cross Blue Shield plans under the group purchasing agreement and from non-contracted private payers in line with historic reimbursement rates. Similarly, Pacific Edge expects collections from our enhanced patient responsibility and patient assistance programs to continue in line with the rates since the introduction of that program in July 2023. Pacific Edge Chief Executive Dr Peter Meintjes said: 'This finalization is a poor outcome for Medicare patients and urologists, as it removes coverage for guideline-recommended testing and followed a flawed process that failed to review the most-current evidence. 'We are obviously disappointed we have been unable to maintain coverage of our tests in the short term. However, as we noted when the final LCD was published in mid-January 2025, we have planned for this possibility. We will update shareholders as these plans are finalized, though our focus will remain on further evidence generation in parallel with the reconsideration pathway made available to all providers seeking Medicare coverage of their tests.' 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 Centers for Medicare and Medicaid Services. 3 The Department of Health and Human Services. 4 Office of the General Counsel (of the Department of Health and Human Services). 5 Under current legislation, MACs are required to consider consensus statements and/or guidelines in determining coverage.
Scoop
27-04-2025
- Health
- Scoop
Medicare LCD Effective; Pacific Edge Seeks Recoverage
Pacific Edge notes the 'Genetic Testing in Oncology: Specific Tests' (L39365) Local Coverage Determination became effective on 24 April 2025 in the US, halting Medicare coverage of Cxbladder tests. Pacific Edge filed for a preliminary injunction and undertook political advocacy efforts directed at the incoming political appointees within CMS2, HHS3 and OGC4 that included substantial support from the American Urological Association (AUA). However, on Wednesday 23 April 2025 a Pennsylvania District Court Judge ruled that her court lacks jurisdiction to hear Pacific Edge's claim against Medicare Administrative Contractor Novitas and CMS. Meanwhile, the lobbying efforts have not yielded a change to the effective date or retirement of the LCD. Pacific Edge, which currently generates ~60% of its US revenue from Medicare, will now focus on the paths available, which include Medicare appeals for Cxbladder Triage to get paid based on its inclusion in the AUA microhematuria guideline5, despite the non-coverage determination and reconsideration requests for Triage and Monitor. Pacific Edge submitted a reconsideration request for Cxbladder Triage under 'Biomarkers for Oncology' LCD (L35396) on 21 March 2025, a request that has already been deemed valid by Novitas, meaning they will now assess the evidence submitted. It also expects to submit a reconsideration request for Cxbladder Monitor under 'Genetic Testing in Oncology: Specific Tests' (L39365) as soon as possible and request non-coverage to be removed. However, Pacific Edge will not seek re-coverage of Cxbladder Detect as no new evidence has been published that can be submitted for reconsideration. Detect users will be required to move over to Triage in an acceleration of a plan intended to coincide with the commercial launch of Triage Plus. Novitas controls the timeline for these reconsideration requests and is not bound by any maximum period to complete this work. Industry experts typically estimate the time at 6-9 months for a valid submission of a single product with only a small number of new supporting publications and not the protracted period of consultation that results from creating a new LCD as was done with L39365. Regarding Cxbladder Triage Plus, the company will continue to develop, publish and subsequently submit a reconsideration request in line with our previously published roadmap – those activities remain on track. The company will also continue to work with Kaiser Permanente on a peer-reviewed publication confirming the real-world utility of Cxbladder Triage. The preliminary data was presented as a poster at the AUA 2025 annual meeting (April 26–29) in Las Vegas and will be used for future reconsideration requests when published. While the impact of 'Genetic Testing for Oncology: Specific Tests' (L39365) is expected to have a significant impact on testing volume, Pacific Edge expects to continue to bill and receive reimbursement from contracted commercial US payers without interruption, notably Kaiser Permanente, the US Veterans Administration, various Blue Cross Blue Shield plans under the group purchasing agreement and from non-contracted private payers in line with historic reimbursement rates. Similarly, Pacific Edge expects collections from our enhanced patient responsibility and patient assistance programs to continue in line with the rates since the introduction of that program in July 2023. Pacific Edge Chief Executive Dr Peter Meintjes said: 'This finalization is a poor outcome for Medicare patients and urologists, as it removes coverage for guideline-recommended testing and followed a flawed process that failed to review the most-current evidence. 'We are obviously disappointed we have been unable to maintain coverage of our tests in the short term. However, as we noted when the final LCD was published in mid-January 2025, we have planned for this possibility. We will update shareholders as these plans are finalized, though our focus will remain on further evidence generation in parallel with the reconsideration pathway made available to all providers seeking Medicare coverage of their tests.' 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 Centers for Medicare and Medicaid Services. 3 The Department of Health and Human Services. 4 Office of the General Counsel (of the Department of Health and Human Services). 5 Under current legislation, MACs are required to consider consensus statements and/or guidelines in determining coverage.
