Sequana Medical FIRST LOOK: FY23 update comes with 90-day FDA letter for alfapump PMA
Sequana reported FY23 results with a cash position of € 2.6m (YE22: € 18.9m), which together with the € 3m convertible loan in February 2024 and € 11.5m equity placement in March 2024, provides a cash runway to end of 3Q24. The company is evaluating the feedback received last night in the 90-day letter from the FDA. Given the short timeframe, management is unable to provide more details on the FDA comments, and will update the market in due course. The company has a day-100 meeting scheduled with the FDA on 9 April 2024, and we expect a more detailed update on timelines subsequently. For now, we reiterate our BUY rating and € 6 TP.Sequana Medical NV. Sequana Medical NV is a Belgium-based company, which manufactures medical devices. The Company focuses mainly on the development of treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders. Sequana Medical NV provides alfapump, which is an implantable, programmable, wireless-charged and battery-powered system that is CE-marking for the management of refractory ascites due to liver cirrhosis and malignant ascites. Over 650 alfapump systems have been implanted. Apart from the Alfapump, the Company also aims to develop a direct sodium removal (DSR) therapy, which is a propriety approach to the treatment of volume overload in heart failure.
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