New Risk • Jun 30
New major risk - Revenue and earnings growth Revenue has declined by 100% over the past year. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If revenues are declining, then it is difficult for the company to prevent its earnings from declining as well. A trend of falling revenue can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Negative equity (-€39m). Revenue has declined by 100% over the past year. Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported June 2025 fiscal period end). Share price has been volatile over the past 3 months (5.3% average weekly change). Shareholders have been diluted in the past year (25% increase in shares outstanding). Market cap is less than US$100m (€43.6m market cap, or US$49.7m). Announcement • May 29
Sequana Medical Presents Data on Recompensation of Decompensated Cirrhosis Following Alfapump Placement At EASL Congress 2026 Sequana Medical NV announced the presentation of data from a post-hoc analysis of the Phase 3 POSEIDON study of alfapump at the European Association for the Study of the Liver (EASL) Cong ress 2026 in Barcelona, Spain. EASL Congress is one of the world’s premier events dedicated to liver health, bringing together physicians, scientists, and allied health professionals from across the globe to share knowledge and highlight breakthroughs across the full spectrum of hepatology. The poster, titled “Recompensation of decompensated cirrhosis and long-term resolution of ascites in patients undergoing alfapump placement: experience from the multi-centre POSEIDON study,” was presented in the Portal Hypertension session. The alfapump is a subcutaneous implantable device that automatically and continuously moves ascites fluid from the abdominal cavity into the bladder, where it is eliminated naturally, freeing patients from dependence on repeated large-volume paracentesis procedures. Of 48 subjects with a functioning alfapump at six months post-implant, 10 achieved recompensation, with a median time to recompensation of 519 days. Key markers of recovery, including declining MELD-Na (Model for End-Stage Liver Disease-Sodium, a standard measure of liver disease severity) scores and rising serum albumin, differentiated those who recompensated from those who did not. Both the Recompensation group (n = 10) and those with Ongoing Decompensation (n = 38) experienced similar post-implant improvements in ascites complaints (Ascites-Q). These findings are preliminary and further data collection is ongoing. The alfapump system received U.S. FDA Premarket Approval in December 2024 for the treatment of recurrent or refractory ascites due to liver cirrhosis. It is the first and currently only U.S.-approved active implantable medical device (Class III) that automatically and continuously removes ascites from the abdomen into the bladder. In August 2025, CMS approved the New Technology Add-on Payment for the alfapump when performed in the hospital inpatient setting, effective October 1, 2025. Price Target Changed • May 20
Price target decreased by 46% to €1.50 Down from €2.77, the current price target is provided by 1 analyst. New target price is 145% above last closing price of €0.61. Stock is down 40% over the past year. The company is forecast to post a net loss per share of €0.17 next year compared to a net loss per share of €1.22 last year.