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Research: Healthcare
Sequana Medical announced in late December that it has submitted a Premarket Approval (PMA) application to the US FDA regarding its alfapump device for use in patients with recurrent and refractory ascites (RRA), meeting its guidance for a submission in Q423. This marks a critical milestone for the company and we expect an FDA decision in H224. Given robust primary efficacy data from the POSEIDON North American pivotal study, as well as favourable safety and efficacy trends maintained at 12 months post-implantation, we are confident that there is a high likelihood of a positive outcome and commercial approval of the product. We believe US approval would mark a pivotal shift in Sequana’s commercial profile, given the strong market need for improved treatments for RRA that can boost patient quality-of-life (QoL), particularly in light of rising prevalence of non-alcoholic steatohepatitis.
Sequana Medical |
PMA application submitted to FDA for alfapump |
Regulatory milestone |
Pharma and biotech |
3 January 2024 |
Share price performance
Business description
Analyst
Sequana Medical is a research client of Edison Investment Research Limited |
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Sequana Medical announced in late December that it has submitted a Premarket Approval (PMA) application to the US FDA regarding its alfapump device for use in patients with recurrent and refractory ascites (RRA), meeting its guidance for a submission in Q423. This marks a critical milestone for the company and we expect an FDA decision in H224. Given robust primary efficacy data from the POSEIDON North American pivotal study, as well as favourable safety and efficacy trends maintained at 12 months post-implantation, we are confident that there is a high likelihood of a positive outcome and commercial approval of the product. We believe US approval would mark a pivotal shift in Sequana’s commercial profile, given the strong market need for improved treatments for RRA that can boost patient quality-of-life (QoL), particularly in light of rising prevalence of non-alcoholic steatohepatitis.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
0.4 |
(24.4) |
(1.36) |
0.0 |
N/A |
N/A |
12/22 |
0.9 |
(30.9) |
(1.37) |
0.0 |
N/A |
N/A |
12/23e |
0.7 |
(31.8) |
(1.14) |
0.0 |
N/A |
N/A |
12/24e |
1.8 |
(33.1) |
(1.17) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
The PMA filing is based on the positive results and successful execution of Sequana’s pivotal POSEIDON study across 18 sites in the US and Canada where 69 patients were implanted with the alfapump, including the 40 patients in the pivotal cohort that comprised the primary efficacy analysis. The primary effectiveness endpoints recorded at six months post-transplantation were convincingly met, with the first being the median reduction in therapeutic paracentesis (TP). Among the 40 pivotal cohort patients, POSEIDON achieved 100% median reduction (p<0.001) in the post-implant observation period (reflecting months four to six) compared to the three-month pre-implant observation period, while the study’s aim was to show at least a 50% reduction. The second effectiveness endpoint was that 77% of the 40 patients experienced at least a 50% reduction in the frequency of TP procedures in the post-implant observation period versus the pre-implant observation period (p<0.001). The study’s aim was to show that at least 50% of patients would achieve this reduction rate.
Sequana in Q423 reported 12-month post-implantation data, showing that 19 evaluable patients with refractory ascites consistently experienced a 100% median reduction in TP, affirming the sustained effectiveness of the alfapump in managing ascites and reducing the need for invasive TP procedures. Importantly, the rate of major adverse events and serious infections remained within anticipated levels, reflecting the device’s manageable safety profile, and patients maintained stable renal function. Patients’ QoL also benefited from the alfapump, where despite the progression of their underlying condition (ascites), a meaningful improvement in their QoL was maintained at 12 months post-implant (vs three months pre-implant). Altogether, the 12-month data reinforce our confidence in a positive outcome from the PMA process, which we anticipate can lead to US launch in H224.
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Research: Metals & Mining
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