Sequana Medical — PMA application submitted to FDA for alfapump

Sequana Medical (BRU: SEQUA)

Last close As at 24/04/2024

2.95

0.14 (4.98%)

Market capitalisation

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Research: Healthcare

Sequana Medical — PMA application submitted to FDA for alfapump

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.

Written by

Pooya Hemami

Analyst - Healthcare

Close up of Doctor is showing medical analytics data of Coronavirus (Covid-19), Medical technology concept

Healthcare

Sequana Medical

PMA application submitted to FDA for alfapump

Regulatory milestone

Pharma and biotech

3 January 2024

Price

€4.15

Market cap

€117m

Net cash (€m) at 30 June 2023, excluding leases

0.3

Shares in issue

28.2m

Free float

45%

Code

SEQUA

Primary exchange

Euronext

Secondary exchange

N/A

Share price performance

Business description

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

Analyst

Pooya Hemami, OD MBA, CFA

+1 646 653 7026

Sequana Medical is a research client of Edison Investment Research Limited

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
end

Revenue
(€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

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.

General disclaimer and copyright

This report has been commissioned by Sequana Medical and prepared and issued by Edison, in consideration of a fee payable by Sequana Medical. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

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Australia

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New Zealand

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United Kingdom

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London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

General disclaimer and copyright

This report has been commissioned by Sequana Medical and prepared and issued by Edison, in consideration of a fee payable by Sequana Medical. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2024 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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