Sequana Medical - On track to meet key milestones
Sequana Medical has affirmed its guidance for its two lead programmes, the implantable alfapump device for recurrent and refractory ascites (RRA) and Direct Sodium Removal (DSR) 2.0 for diuretic-resistant congestive heart failure (CHF). Sequana is on track to submit a PMA application for the alfapump with the US FDA in Q423, which we believe could lead to US commercialisation in H224. Pre-launch activities are advancing and Sequana seems optimistic about the reimbursement path. It estimates the alfapump could be priced at $25k or more, with potential for higher payments via the NTAP designation. With the enrolment of the first patient in the non-randomised cohort of the MOJAVE Phase I/IIa DSR 2.0 study in July, the company continues to expect to report interim data on this cohort (n=3) by the end of 2023. It seeks to confirm the safety and efficacy shown with the first-generation product (DSR 1.0) and provide an early efficacy signal in US patients of DSR 2.0’s potential as a disease-modifying CHF treatment. After rolling forward our estimates and adjusting for forex, we obtain a pipeline rNPV valuation of €359.5m (€334.1m previously).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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