vital sign monitoring concept. 3d rendering. abstract mixed media.

Completion of POSEIDON study implantations

Sequana Medical 8 April 2022 Update
Download PDF

Sequana Medical

Completion of POSEIDON study implantations

Clinical study update

Pharma & biotech

8 April 2022

Price

€6.66

Market cap

€158m

$1.09/€

Net cash (€m) at 30 June 2021 (excluding €0.3m lease liabilities)

14.7

Shares in issue

23.75m

Free float

45%

Code

SEQUA

Primary exchange

Euronext

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

20.0

(10.8)

(26.2)

Rel (local)

6.1

(7.7)

(30.4)

52-week high/low

€9.68

€5.50

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.

Next events

Top-line results of SAHARA DESERT study

H222

Top-line results of POSEIDON study

Q422

Analyst

Pooya Hemami, CFA

+1 646 653 7026

Sequana Medical is a research client of Edison Investment Research Limited

On 5 April, Sequana announced that it has completed all implantations required for the North American POSEIDON pivotal study assessing the alfapump device for the treatment of recurrent or refractory ascites (RRA) due to liver cirrhosis. Of the 71 patients enrolled in the study’s pivotal cohort, 40 have been implanted with the device. Top-line data are expected in Q422, and 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. Sequana also recently completed a €28.4m (gross) equity raise, which should extend its operating runway into Q223. The dilutive effects of the offering are largely offset by rolling forward our estimates and our equity value per basic share is €13.55 (versus €14.55 previously).

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

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

(21.9)

(0.92)

0.0

N/A

N/A

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

Fewer evaluable patients than planned

Sequana previously planned to have c 50 implanted (and c 40 evaluable) patients in the POSEIDON pivotal cohort. We anticipate an attrition rate of around five to 10 patients by the six-month post-implantation endpoint analysis point (given the severe disease status of RRA subjects), which could cause the number of evaluable subjects to be c 13–25% below the company’s earlier target. As trends shown in recent interim analyses significantly exceed the primary endpoints as defined for the pivotal cohort, we are confident there is likely to be a sufficient efficacy buffer or margin (assuming the pivotal cohort data are similar to roll-in cohort data to date) for the pivotal cohort to meet the primary endpoint targets despite fewer evaluable patients) than originally planned.

€28.4m financing extends runway into Q223

In March, Sequana raised €28.4m (gross) though the issue of 5.167m shares at €5.50 per share. We believe this should fund operations past the POSEIDON top-line data readout, which, if positive, could trigger a re-rating on the stock. We have reduced our future total financing expectations to €100m (from €125m previously), which we model that the company will raise in the coming years as illustrative debt.

Valuation: Increasing pipeline rNPV to €296m

As the number of evaluable POSEIDON subjects will likely be lower than we anticipated, we have reduced our probability of success estimate for alfapump in North America to 55% (from 60%) but this is more than offset by rolling forward our estimates. We now obtain a pipeline rNPV valuation of €296.4m versus €255.7m, previously. After adding Q122e net cash of €25.4m, we obtain an equity valuation of €321.8m or €13.55 per basic share (versus €14.55 previously).

POSEIDON implantations now complete

Sequana met a key milestone for its North American POSEIDON pivotal study for the treatment of RRA due to liver cirrhosis, by completing all the alfapump implantations required for the study, as announced on 5 April. Enrolment was completed in December 2021 and, of the 71 patients enrolled in the study’s pivotal cohort, 40 have been implanted with the alfapump. Top-line efficacy data from this cohort are still expected in Q422 and the company expects to submit a US PMA application in mid-2023, which we believe could lead to a US launch in mid-2024.

As a reminder, POSEIDON is single-arm, open-label, within-subject crossover study, whereby patients serve as their own controls. 29 patients were enrolled in a training (or ‘roll-in’) cohort (which will be excluded from primary efficacy analysis but included in the safety analysis), to ensure centres are experienced in using the alfapump before the actual study (pivotal) cohort is enrolled.

Patients in the pivotal cohort entered a three-month pre-implant observation period in which they received standard-of-care (SoC) therapy, consisting of therapeutic paracentesis (TP), before the alfapump was implanted. Eligible patients were implanted with the alfapump.

Given the severe disease status of patients with RRA due to liver cirrhosis, as described in our initiation report, we estimate that c 44% patients who met the inclusion criteria at enrolment (71) no longer met the required criteria for implantation at the end of the three-month observation period, leading to a final implantation number of 40 patients. Furthermore, the COVID-19 pandemic, together with the resulting healthcare restrictions and effects on the RRA population (who tend to have weaker immune status than the general population), may have exacerbated the decline in the proportion of enrolled subjects in this study who eventually underwent implantation.

Following implantation, a three-month stabilisation period began whereby the patients’ alfapump settings were adjusted as needed and patients were fully trained. After the stabilisation period, a three-month, post-implant observation period began. Primary effectiveness outcomes include:

the proportion of patients with a 50% reduction in the overall average frequency of TP per month in the post-implant observation period (reflecting month four to month six after implantation) compared to the pre-implant observation period; and

whether at least 50% of patients receive a 50% reduction in their monthly frequency of required TP post-implantation compared to the average monthly number of TP required pre-implantation.

POSEIDON evaluable patients could be lower than planned

In December 2021, Sequana reiterated its objective for POSEIDON, which was to enrol c 70 patients in the pivotal cohort, implant the alfapump in 50 of those patients and obtain c 40 patients evaluable for the primary efficacy analysis. Within this, given the severe disease status and lower life expectancy of the RRA population, is the assumption that a number of implanted patients may not be evaluable six months post-implantation.

With Sequana now confirming that the total number of implanted patients within the pivotal cohort is 40, we estimate that the number of patients evaluable for primary efficacy analysis is likely be c 30–35, or c 13–25% below the company’s earlier target. As described in a prior note, the second interim analysis of the study roll-in cohort from July 2021 showed that subjects had a greater than 90% reduction in mean frequency of TP versus baseline, and 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 in the pivotal cohort, we are confident that there is likely to be a sufficient efficacy buffer or margin (assuming the pivotal cohort data would be similar to the roll-in cohort data to date) for the pivotal cohort to still meet the primary endpoint targets despite the lower number of evaluable patients than originally planned. For instance, we estimate that a 90% reduction in the overall average frequency of TP (similar to that shown in the roll-in cohort) in a sample size of 30–35 would provide a stronger statistical signal than a 50% reduction in a sample size of 40. Further, as stated above, once enrolment in the pivotal cohort began, study centres had already accumulated more experience with the alfapump system (compared to when they were enrolling the roll-in cohort). We believe this provides the potential for the data resulting from this cohort to be more robust than that reported to date from the roll-in cohort.

Patient survival trends generally favourable in roll-in cohort

Given that the overall intent of alfapump is to improve quality of life (by reducing the need for TP) in RRA patients, Sequana has not attempted to assess whether the alfapump could have any effect on overall mortality. In addition, designing a study to assess mortality would require larger enrolment and a control arm, which would greatly lengthen development times and costs. Nonetheless, Sequana reported a preliminary interim analysis (as of 25 March 2022) of patient survival in the roll-in cohort following alfapump implantation, which showed a mean survival probability of 70% at 12 months. This compares favourably with published reports (Biggins et al. as cited in the American Association for the Study of Liver Diseases Practice Guidance; Moreau et al),1 which found a 12-month survival rate for refractory ascites patients of only c 50%.

Exhibit 1: Kaplan Meier – preliminary survival rate analysis of roll-in cohort, 25 March 2022

Source: Sequana Medical, GlobeNewswire

Given the general poor state of health of patients with RRA, including weakened immunity and poor renal function, we believe it would be challenging for any treatment to show a significant change in mortality, taking account of the multitude of conditions or events that such patients could inevitably experience and the difficulty in controlling a trial for such aspects. Hence, while we apply caution in comparing the roll-in cohort result with historical outcomes in the RRA population (given differing study and inclusion criteria), the company’s reporting of lower 12-month mortality may potentially bode well for the overall safety dossier of the device (when the PMA is to be filed in 2023). Further, we reiterate that the primary benefit of the alfapump in the RRA population is to provide a convenient and unobstructive long-term therapy to improve patient independence and quality of life (QoL) and reduce the need for TP. Ascites results in a loss of appetite, sleeping and mobility difficulties and commonly requires time-consuming and burdensome TP procedures, which must often be repeated as the ascites re-accumulate. By reducing the frequency of required TP post-implantation, the alfapump can potentially greatly improve patient independence and QoL.

Financials

Sequana strengthened its balance sheet through an equity issue in early March, raising €28.4m (gross) though the issue of 5.167m shares at €5.50 per share. Notably, Partners in Equity (PiE), an experienced institutional investor in healthcare companies, subscribed to 3.6m shares, representing 15.3% of the company's shares after the offering.

The company expects net proceeds from the offering to extend its operating cash runway into Q223 (from Q222 previously). Importantly, the financing should fund the company well through the POSEIDON study’s top-line data readout, expected in Q422. We believe this particular milestone is very critical and, if positive, could trigger a re-rating of the stock as it would signal an improved likelihood of success for advancing the alfapump system in RRA for the all-important US market, which is the largest driver of our valuation for the product in this indication. As well as completing the POSEIDON study, the company indicates that portions of the funding will be allocated to: the preparation of the PMA filing for alfapump (which we assume is contingent on positive POSEIDON data), activities for the completion of the SAHARA DESERT study (expected in H222), continuing to develop its proprietary DSR Infusate 2.0 and working on initiation for the MOJAVE DESERT US feasibility study for short-term direct sodium removal (DSR) therapy (which will use DSR Infusate 2.0 and is scheduled to start in H222).

Following the Q122 equity raise, we have reduced our future total financing expectations to €100m (from €125m previously), which we model that Sequana will raise over the next few years until it starts to generate sustained positive operating cash flows (which we continue to expect in H127). We have not modified our forecasts in local currency terms (for instance, in US dollars for the US market) but have adjusted our FX rate to $1.09/€ (from $1.13/€ previously). Following minor financial income/expense adjustments, our net operating cash burn rate assumptions are little changed, and we expect rates of €22.6m and €23.0m for 2021 and 2022 respectively. Sequana reported H121 net cash of €14.7m (excluding lease liabilities) and, based on our assumptions described above and the Q122 financing, we currently estimate 31 March 2022 net cash of c €25.4m. The company is expected to report FY21 results on 12 April 2022, and we will update our forecasts following this release.

Valuation

We continue to value Sequana Medical using a risk-adjusted NPV model with a 12.5% cost of capital for alfapump in North America and alfapump DSR, and a 10% rate for alfapump in ex-North American markets (where it is commercialised). Given the reduction in our estimate of the number of evaluable patients in the pivotal arm of the POSEIDON study (30–35 vs 40 previously), we have mildly reduced the probability of success for alfapump in the North American market to 55%, from 60% previously. We continue to remain confident in alfapump’s efficacy profile to date (given the interim POSEIDON data cited above) and in the likelihood that POSEIDON will meet the efficacy endpoint, but we believe that a mild adjustment in our probability estimate is warranted as the statistical power of the overall data set will be affected by the reduced evaluable subject sample size. We have also adjusted our forex forecasts (as described above) and rolled forward our estimates.

Exhibit 2: Sequana Medical rNPV assumptions

Product contribution

Indication

Stage

NPV
(€m)

Prob of success

rNPV
(€m)

rNPV/basic share (€)

Launch year

Sales (€m) in 2032

alfapump in North America (net of R&D and SG&A costs)

Refractory and recurrent ascites and malignant ascites

Pivotal study ongoing

250.5

55%

135.1

5.69

Mid-2024

191.7

alfapump in Europe and ex-NA regions (net of SG&A costs)

Refractory and recurrent ascites and malignant ascites

Commercial/ marketed

3.6

100%

3.6

0.15

2013

3.4

alfapump DSR and short-term DSR

Fluid overload in heart failure

Human feasibility studies

891.4

25%

212.8

8.96

H226 in US

473.8*

Corporate costs

(55.1)

100%

(55.1)

(2.32)

Total

1,090.4

296.4

12.48

Net cash (Q122e) excluding lease liabilities

25.4

25.4

1.07

Total equity value

1,115.8

321.8

13.55

Basic shares outstanding (000) (10 March 2022)

23,747

Outstanding warrants and share options

1,812

Fully diluted shares outstanding (000) (10 March 2022)

25,559

Source: Edison Investment Research. Note: *Reflects estimate of projected transfer pricing revenue to Sequana Medical rather than end-market commercial sales.

Following these adjustments, we now obtain a pipeline rNPV valuation of €296.4m versus €255.7m, previously. After adding Q122e net cash of €25.4m (excluding lease liabilities), we obtain an equity valuation of €321.8m or €13.55 per share (€12.59 fully diluted), versus €14.55 previously (€13.30 fully diluted).

Exhibit 3: Financial summary

€’000s

2018

2019

2020

2021e

2022e

2023e

2024e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

1,029

971

963

525

1,214

1,396

3,793

Cost of Sales

(158)

(198)

(202)

(105)

(243)

(279)

(759)

Gross Profit

871

773

761

420

971

1,117

3,035

General & Administrative

(8,206)

(7,102)

(6,738)

(7,103)

(7,038)

(8,529)

(14,066)

Net Research & Development

(5,816)

(7,652)

(11,835)

(15,606)

(15,500)

(12,000)

(12,500)

Operating profit before exceptionals

(13,150)

(13,981)

(17,813)

(22,289)

(21,567)

(19,412)

(23,531)

EBITDA

 

 

(13,070)

(13,737)

(17,506)

(22,117)

(21,380)

(19,275)

(23,427)

Depreciation & other

(81)

(244)

(307)

(172)

(187)

(137)

(104)

Operating Profit (before amort. and except.)

(13,150)

(13,981)

(17,813)

(22,289)

(21,567)

(19,412)

(23,531)

Exceptionals including asset impairment

74

18

41

17

0

0

0

Operating Profit

(13,077)

(13,964)

(17,771)

(22,272)

(21,567)

(19,412)

(23,531)

Net Interest

(883)

(878)

(1,178)

(416)

(322)

(1,323)

(3,394)

Profit Before Tax (norm)

 

 

(14,033)

(14,859)

(18,991)

(22,705)

(21,888)

(20,735)

(26,925)

Profit Before Tax (FRS 3)

 

 

(13,960)

(14,841)

(18,949)

(22,688)

(21,888)

(20,735)

(26,925)

Tax

(24)

(136)

(157)

(129)

0

0

0

Profit After Tax and minority interests (norm)

(14,057)

(14,995)

(19,148)

(22,834)

(21,888)

(20,735)

(26,925)

Profit After Tax and minority interests (FRS 3)

(13,983)

(14,977)

(19,106)

(22,817)

(21,888)

(20,735)

(26,925)

Average Number of Shares Outstanding (m)

10.0

12.3

15.3

18.3

23.7

23.8

23.9

EPS - normalised (€)

 

 

(1.41)

(1.22)

(1.25)

(1.25)

(0.92)

(0.87)

(1.13)

EPS - normalised and fully diluted (€)

 

(1.41)

(1.22)

(1.25)

(1.25)

(0.92)

(0.87)

(1.13)

EPS - (IFRS) (€)

 

 

(1.40)

(1.22)

(1.25)

(1.25)

(0.92)

(0.87)

(1.13)

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

242

829

772

640

486

385

376

Tangible Assets

184

765

705

561

407

305

296

Investments in long-term financial assets

58

63

67

79

79

79

79

Current Assets

 

 

3,099

8,522

13,441

12,142

16,846

20,603

19,415

Short-term investments

0

0

0

0

0

0

0

Cash

1,318

5,586

11,016

11,035

15,574

20,013

17,601

Other

1,782

2,935

2,425

1,107

1,273

590

1,814

Current Liabilities

 

 

(18,727)

(5,315)

(5,966)

(4,950)

(3,464)

(2,490)

(2,846)

Creditors

(6,654)

(4,855)

(5,966)

(4,950)

(3,464)

(2,490)

(2,846)

Short term borrowings

(12,073)

(459)

0

0

0

0

0

Long Term Liabilities

 

 

(3,374)

(3,110)

(8,135)

(7,839)

(7,839)

(32,839)

(57,839)

Long term borrowings

(2,582)

(2,261)

(7,473)

(7,089)

(7,089)

(32,089)

(57,089)

Other long-term liabilities

(792)

(849)

(662)

(750)

(750)

(750)

(750)

Net Assets

 

 

(18,760)

926

113

(8)

6,029

(14,342)

(40,895)

CASH FLOW

Operating Cash Flow

 

 

(8,987)

(17,596)

(15,791)

(22,087)

(22,674)

(19,202)

(23,923)

Net interest and financing income (expense)

(883)

(878)

(1,178)

(416)

(322)

(1,323)

(3,394)

Tax

(5)

(9)

(36)

(85)

0

0

0

Net Operating Cash Flow

 

 

(9,875)

(18,482)

(17,005)

(22,588)

(22,995)

(20,526)

(27,317)

Capex

(39)

(106)

(138)

(71)

(34)

(35)

(95)

Acquisitions/disposals

0

0

0

0

0

0

0

Financing (net of costs)

2

26,165

19,000

22,768

27,567

0

0

Dividends

0

0

0

0

0

0

0

Other

0

0

0

0

0

0

0

Net Cash Flow

(9,912)

7,576

1,857

109

4,538

(20,560)

(27,412)

Opening net debt/(cash)

 

 

0

13,337

(2,866)

(3,543)

(3,946)

(8,484)

12,076

HP finance leases initiated

0

0

0

0

0

0

0

Other

(3,425)

8,627

(1,179)

293

0

0

0

Closing net debt/(cash)

 

 

13,337

(2,866)

(3,543)

(3,946)

(8,484)

12,076

39,488

Lease debt

N/A

504

387

343

343

343

343

Closing net debt/(cash) inclusive of IFRS 16 lease debt

13,337

(2,362)

(3,157)

(3,603)

(8,141)

12,419

39,831

Source: company data, Edison Investment Research


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 2022 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

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

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 2022 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

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

Share this with friends and colleagues