We use cookies to improve your experience, analyze site usage, and show relevant ads. Go to our Privacy Policy for details.
The call conveyed meaningful commercial, scientific and reimbursement progress: a successful product launch, strong clinical publications and podium presence, an awarded Medicare pricing of USD 897, state approvals in 48 states, targeted hiring of account managers, and a completed rights issue that improved cash position. However, near-term revenue remains limited, full payer coverage is not yet granted, cash runway extends only to Q3 2026 without additional capital, and realized per-test pricing and collections are still uncertain. The company emphasized disciplined spending, planned clinical utility data collection (including a 400-patient registry) and a mid-2026 Medicare submission with rolling data updates to mitigate coverage risk.
Management guided that PancreaSure’s targeted advocacy phase (launched Sept 2025) will continue through Q2 2026 with a Medicare coverage submission planned mid‑2026 and meaningful revenue expected in 2027; they’ve hired 3 strategic account managers, received California approval in January, expect New York approval shortly, note approvals in 48 states with all 50 expected by mid‑2026, and have begun billing insurers. Key metrics cited: 5 clinical studies published (CLARITI honored), SEK 140m+ raised for launch, Q4 revenue SEK 354k (vs SEK 455k prior year), Q4 operating loss SEK 16.4m (vs SEK 30.1m), Q4 cash burn SEK 6.6m/month (guidance to return to SEK 8–10m/month), cash SEK 77.5m at Dec‑31 after a SEK 100m rights issue (SEK 69.8m net proceeds) giving runway through Q3 2026, a registry target of ~400 patients in 2026, commercial traction of 4 new centers in Q4 with a pipeline of 6 centers regularly using, 6 in early use, 8 registered and 9 late‑stage prospects (UC Health >100 tests), and a Medicare price established at USD 897 per test.
PancreaSure commercially launched in September 2025 with initial adoption at high-risk surveillance centers; 6 centers regularly using the test at year-end and 4 new centers added in Q4. UC Health >100 tests performed; strong order activity reported at Northwestern Medicine and HonorHealth.
Secured a Medicare reimbursement rate of USD 897 and an appropriate billing code, positioning the company for substantial per-test reimbursement once coverage decisions are granted.
Five clinical studies published in scientific journals, PancreaSure data selected for podium presentations at five meetings, and the CLARITI study named best of DDW, demonstrating robust scientific validation and visibility.
Laboratory/service approvals in 48 of 50 U.S. states (96%); California approval received in January 2026 and New York approval pending (inspection completed with 4 minor findings already addressed).
Completed a rights issue of SEK 100 million (88% subscribed by existing shareholders) delivering a net cash injection of SEK 69.8 million; earlier fundraising referenced of over SEK 140 million to support launch and studies. Achieved reduced operating losses and lower cash burn via R&D cost reductions and cost discipline.
Hired 3 strategic account managers with industry experience (Exact Sciences, Quest, Myriad) to expand outreach, accelerate pipeline conversion, integrate the test into center protocols, and deepen relationships across surveillance center teams.
Three clinical validation studies completed (two published with AFFIRM pending publication), two clinical utility studies underway, and a planned registry targeting ~400 patients in 2026; plan to submit for Medicare coverage mid-2026 with rolling data updates.
Q4 operating loss narrowed to SEK 16.4 million from SEK 30.1 million year-over-year (approximate reduction of 45.5%), and cash burn in Q4 was SEK 6.6 million/month, below prior guidance of SEK 8–10 million/month (17.5%–34% lower).
Good morning, everyone. This is Jeff Borcherding. Thank you very much for joining the call this morning. We are excited to speak with you about the fourth quarter for 2025 and what lies ahead as we continue to build on the success of the PancreaSure launch and prepare for securing reimbursement and continuing to drive the success of this product as we move to achieve our mission of changing the way we detect cancer in pancreatic cancer and making a significant difference in people's lives. For our agenda today, we will do a brief review of 2025. We'll go into more detail about the PancreaSure commercial results in the fourth quarter of the year. We'll then talk about our progress towards reimbursement with a special focus on the clinical studies that lie ahead as well as the steps that we've already accomplished. And then finally, I'll turn it over to my colleague, Adam Backstrom, to discuss the Q4 financial results and our cash position.
In 2025, more than 2 years of development and clinical research culminated in the commercial launch of PancreaSure. And as we look back on 2025, there are a number of things that we're proud of as a company, but here are some of the highlights. Certainly, at the top of the list has to be the commercial launch of the PancreaSure test. A couple of years ago, we made the difficult decision to remove our IMMray PanCan-d test from the market and bring to the market a better test that could detect cancers earlier, could do it with a greater level of sensitivity and specificity, particularly for those people who don't secrete CA19-9. We also wan...