Sequana Medical - Key programmes advancing as expected
Sequana recently reported FY22 results and essentially confirmed its development guidance trajectory for its two key programmes, the implantable alfapump device in patients with recurrent and refractory ascites (RRA) and its direct sodium removal (DSR) 2.0 programme for diuretic-resistant chronic heart failure (CHF). The company remains on track to file a US premarketing approval (PMA) application with the FDA for its alfapump in H223, which we assume could lead to US market launch in mid-2024. Having recently reported positive Good Laboratory Practice (GLP) animal studies for DSR 2.0, the company continues to aim to start the US MOJAVE Phase I/IIa study for DSR 2.0 in Q223, with interim data still planned in H223. Top-line MOJAVE data are now guided for H224, a minor shift from mid-2024 previously, but this does not affect our launch timing forecasts for DSR 2.0. After making the minor adjustments to our valuation discussed below, we now have an rNPV valuation to €344.3m (previously €345.0m).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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