Equity research Immunovia Q4 2025: Targeting Medicare sub-mission by mid-2026

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Immunovia shows solid progress in increasing the penetration of US centres for surveillance of pancreatic cancer risk. It plans to submit for Medicare coverage for the PancreaSure test in mid-2026 to support more meaningful sales from 2027 onwards.

Modest sales in Q4, but broadened availability of the PancreaSure test

Following the launch of the PancreaSure test in the US in Q3 2025, Immunovia recorded its first commercial sales in Q4. From the total net sales of SEK 0.4m (0.5), which also include non-related royalty income, we deduce that initial test sales were modest in absolute terms and that test volumes were lower than we had anticipated. However, as the test is not yet reimbursed, the initial phase of commercialisation is primarily focused on achieving targeted adoption in a gradually expanding number of key high-risk surveillance centres. In this regard, Immunovia states that approximately 20 centres have either used the test or registered to use it. This is up from ten in September 2025, and in line with previously stated ambitions. So far in 2026, Immunovia has also made headway toward state approvals in California and New York for the PancreaSure test and has strengthened the sales team by three people. We expect net sales to gradually increase, albeit still modest in absolute terms, in H1 2026.

Submission for Medicare coverage key expected milestone in 2026

Immunovia says it expects to have initial clinical utility data in Q2 and plans to submit for Medicare coverage in mid-2026. Hence, the company targets rapid progress towards securing some reimbursement, possibly already this year. The progress is contingent on successful penetration into and increased test usage in a growing number of high-risk surveillance centres to secure sufficient real-world clinical utility data for Medicare submission.

Shares are trading close to our updated bear case valuation

Operating cash flow in the period at SEK -20m (-28.3) was again better than the previous guidance of a negative SEK 8-10m per month and our expectations. The lower-than-expected costs are partly due to the timing of sales team/key account manager recruitment, which was delayed to the current quarter. Also, R&D costs declined. Immunovia reiterated the expected financial runway through Q3 2026.

Following the Q4 2025 report, we have lowered our sales estimates by on average about eight per cent 2026-2028E, driven by a somewhat slower test sales trajectory, exacerbated by a weaker USD than previously assumed and uncertainty regarding reimbursement timelines. Chiefly due to a review of our assumptions about future equity financing and dilution following the recent share price slump, we have adjusted our base-case valuation. Potential catalysts include progress in clinical development and reimbursement, as well as a long-term funding solution.

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