Sequana Medical (BRU: SEQUA)

Currency in EUR

Last close As at 30/11/2023

EUR2.65

0.19 (7.72%)

Market capitalisation

EUR75m

Based in Belgium, Sequana Medical develops products to treat diuretic-resistant fluid overload, a frequent complication of liver disease and heart failure (HF). Its proprietary alfapump and Direct Sodium Removal (DSR) approaches aim to provide significant clinical and quality-of-life benefits.

Given positive efficacy, safety and quality of life data from its POSEIDON North American registration study for the alfapump in recurrent and refractory ascites, Sequana expects to submit a US Premarket Approval application in Q423, with US approval anticipated in H224. Supported by encouraging data from its Phase IIa SAHARA DSR study in HF patients with persistent congestion, in July 2023 Sequana started a MOJAVE US Phase I/IIa study assessing its second-generation product (DSR 2.0) in a similar patient population. Positive results from the first two MOJAVE patients was reported in October, including the safe and effective treatment of congestion with maintenance of euvolemia without the need for loop diuretics, as well as material benefits in cardiorenal status and in diuretic response.

Latest Insights

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Healthcare | Update

Sequana Medical — MOJAVE early efficacy validates DSR 2.0

Healthcare | Update

Sequana Medical — On track to meet key milestones

Healthcare | Flash note

Sequana Medical — MOJAVE enrols first patient

Healthcare | Update

Sequana Medical — Additional POSEIDON data confirm benefits

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Sector

Healthcare

Equity Analyst

Pooya Hemami

Analyst - Healthcare

Key Management

  • Kirsten Van Bockstaele

    CFO

  • Ian Crosbie

    CEO

Balance Sheet

Forecast net debt (€m)

15.1

Forecast gearing ratio (%)

80

Share Price Performance

Price Performance
% 1M 3M 12M
Actual (4.0) (28.0) (59.7)
Relative (10.0) (24.4) (58.0)
52 week high/low €6.5/€2.3

Financials

Sequana Medical recently announced positive interim data, from the non-randomised cohort of the Phase I/IIa MOJAVE study, in patients with chronic heart failure (CHF) and severe diuretic resistance treated with Direct Sodium Removal (DSR) 2.0. Data from the first two patients demonstrated that DSR 2.0 is safe and well tolerated and that it exhibits robust initial signs of efficacy, confirming the efficacy signals seen with the first-generation product (DSR 1.0) in the SAHARA and RED DESERT studies and highlighting potential of a disease-modifying treatment. Sequana also reported favourable developments with its recurrent and refractory ascites (RRA) programme for the alfapump, including positive efficacy and safety in 12-month data from the POSEIDON pivotal study, a patient preference study showing positive potential demand among the US RRA population, and a comparable safety profile to standard-of-care (SoC) following a matched interim analysis between POSEIDON and the NACSELD registry. Importantly, the company remains on track to submit a PMA application in Q423, which could lead to US approval in H224.

Y/E Dec Revenue (€m) EBITDA (€m) PBT (€m) EPS (fd) (c) P/E (x) P/CF (x)
2021A 0.4 (23.4) (24.4) (136.37) N/A N/A
2022A 0.9 (28.3) (30.9) (137.33) N/A N/A
2023E 0.7 (29.9) (31.8) (113.66) N/A N/A
2024E 1.8 (29.7) (33.1) (117.06) N/A N/A

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