Sequana Medical — POSEIDON enrolment completed on schedule

Sequana Medical (BRU: SEQUA)

Last close As at 01/11/2024

2.95

0.14 (4.98%)

Market capitalisation

83m

More on this equity

Research: Healthcare

Sequana Medical — POSEIDON enrolment completed on schedule

Meeting its recent Q421 guidance, Sequana has completed patient enrolment for the POSEIDON North American pivotal study assessing the alfapump system for the treatment of recurrent or refractory ascites (RRA) due to liver cirrhosis. 70 patients have been enrolled in the pivotal cohort, with Sequana expecting to implant 50 of these with the alfapump by the end of Q122. This should allow Sequana to meet its pre-defined target of having 40 evaluable patients for the primary efficacy analysis at six months post-implantation, which continues to be expected in Q422. The company expects to submit a US pre-market approval (PMA) application in mid-2023, which we believe could lead to a US launch in mid-2024.

Written by

Pooya Hemami

Analyst - Healthcare

Healthcare

Sequana Medical

POSEIDON enrolment completed on schedule

Clinical trial update

Pharma & biotech

6 December 2021

Price

€6.92

Market cap

€129m

Net cash (€m) at 30 June 2021

(excluding €0.3m lease liabilities)

14.7

Shares in issue

18.58m

Free float

50%

Code

SEQUA

Primary exchange

Euronext

Secondary exchange

N/A

Share price performance

Business description

Based in Belgium, Sequana Medical develops devices based on its alfapump platform for the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure. Alfapump is CE marked for refractory ascites and is in a pivotal North American study for this indication.

Analysts

Pooya Hemami, CFA

+1 646 653 7026

Maxim Jacobs, CFA

+1 646 653 7027

Sequana Medical is a research client of Edison Investment Research Limited

Meeting its recent Q421 guidance, Sequana has completed patient enrolment for the POSEIDON North American pivotal study assessing the alfapump system for the treatment of recurrent or refractory ascites (RRA) due to liver cirrhosis. 70 patients have been enrolled in the pivotal cohort, with Sequana expecting to implant 50 of these with the alfapump by the end of Q122. This should allow Sequana to meet its pre-defined target of having 40 evaluable patients for the primary efficacy analysis at six months post-implantation, which continues to be expected in Q422. The company expects to submit a US pre-market approval (PMA) application in mid-2023, which we believe could lead to a US launch in mid-2024.

Year end

Revenue (€m)

PBT*

(€m)

EPS*
(€)

DPS
(€)

DPS
(%)

Yield
(%)

12/19

1.0

(14.9)

(1.22)

0.0

N/A

N/A

12/20

1.0

(19.0)

(1.25)

0.0

N/A

N/A

12/21e

0.5

(22.7)

(1.25)

0.0

N/A

N/A

12/22e

1.2

(22.8)

(1.22)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

Sequana reported its second interim results in July from the POSEIDON study roll-in cohort. As outlined in our prior note, this second interim analysis showed that subjects in the roll-in cohort had a greater than 90% reduction in mean frequency of therapeutic paracentesis (TP) versus baseline. Furthermore, all patients experienced at least a 50% reduction in mean TP frequency per month versus baseline. As these trends substantially exceed the primary endpoints as defined for the pivotal cohort, we anticipate that the POSEIDON study would meet the primary endpoint if trends shown in the roll-in cohort are maintained. Provided alfapump receives North American approval, we expect sales prospects to be driven by the rising prevalence of non-alcoholic steatohepatitis, which we project will contribute to the US incidence of RRA rising by c 7% pa through 2030.

We continue to expect that Sequana’s funds on hand should be sufficient for it to maintain operations into Q222 and model that the company will raise €20m in 2022 (modelled as illustrative debt). Our unchanged financial assumptions are described in our most recent update note.

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 2021 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.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

More on Sequana Medical

View All

Latest from the Healthcare sector

View All Healthcare content

Research: Consumer

bet-at-home — FY21 guidance reiterated

bet-at-home (BAH) has reported headline figures for its delayed Q321 results. The results reflect a combination of a tough comparative from Q320, the ongoing effects of German regulation changes from the middle of October 2020, and evidence of good cost control. Full financials have not been disclosed as the company continues to evaluate the accounting treatment of activities post the decision to cease some operations in Austria. Management has reiterated its guidance for FY21, indicating a better performance on an underlying basis.

Continue Reading

Subscribe to Edison

Get access to the very latest content matched to your personal investment style.

Sign up for free