Sequana Medical — MOJAVE early efficacy validates DSR 2.0

Sequana Medical (BRU: SEQUA)

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Research: Healthcare

Sequana Medical — MOJAVE early efficacy validates DSR 2.0

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.

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

MOJAVE early efficacy validates DSR 2.0

Clinical data update

Pharma and biotech

13 November 2023

Price

€2.69

Market cap

€76m

$1.07/€

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

%

1m

3m

12m

Abs

5.5

(21.8)

(58.5)

Rel (local)

8.6

(15.4)

(55.7)

52-week high/low

€6.6

€2.3

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.

Next events

Alfapump PMA submission to US FDA

Q423

Additional data from non-randomised cohort in MOJAVE Phase I/IIa DSR 2.0 study

Q423

Analysts

Pooya Hemami OD MBA CFA

+1 646 653 7026

Zoe Karamanoli

+44 20 3077 5700

Sequana Medical is a research client of Edison Investment Research Limited

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.

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. EPS are fully diluted.

DSR data point to activity in cardiorenal syndrome

Data from the first two patients in the MOJAVE study demonstrated that DSR 2.0 is safe and well tolerated and exhibits robust initial signs of efficacy. The data are consistent with the previous SAHARA and RED DESERT studies, where new biomarker data also provide insights into the DSR approach’s mechanism of action, and point to a potential use for the treatment of cardiorenal syndrome.

Alfapump continues to show efficacy advantage

Following robust six-month POSEIDON clinical data, where the alfapump showed statistically significant improvements in the need for therapeutic paracentesis (TP) procedures and in quality of life (QoL), the programme’s near-term focus is completion of an FDA Premarket Approval (PMA) application by end-2023. This strategy is supported by recent 12-month POSIDEON data, which maintain the safety and efficacy trends shown at six months, as well as a matched interim analysis of patients from the NACSELD registry and the POSEIDON study’s pivotal cohort showing that the alfapump’s safety profile is comparable to SoC.

Valuation: Maintaining €359.8m valuation

We maintain our forecasts and equity valuation of €359.8m or €12.76/share (€11.64 fully diluted given options outstanding). Obtaining financing is likely to be a near-term strategic priority, as we expect the company’s current cash on hand to maintain its operations into Q124. We continue to project €35m in new financing before end-FY24.

DSR 2.0 may help manage cardiorenal syndrome

Cardiorenal syndrome (CRS) is a series of disorders where acute or chronic dysfunction in either the heart or kidneys can have a negative impact on the function of the other organ. CRS involves a complex interplay between heart failure and kidney disease and often manifests as a self-reinforcing negative feedback cycle with reduced cardiac output leading to decreased glomerular filtration by the kidneys, increased sodium avidity (active salt and water retention) and congestion. The exact cause of CRS is not fully understood, but effective fluid management is a key component to treating these patients.

Currently, loop diuretics are the drug of choice for decongestion therapy but they may exacerbate many of the core mechanisms thought to underly CRS, leading to worsened diuretic resistance and continued CRS. There are approximately one million US hospitalisations from HF each year,1 of which 90% result from fluid overload symptoms, and patients often stay up to five days. These long stays pose a financial challenge for hospitals as existing treatments with loop diuretics show limited effectiveness, and about 25% of these cases due to congestion are readmitted within 30 days (c 50% are readmitted within six months).2 Therefore, effective management of fluid overload for a sufficient amount of time is critical both for patients and payers (insurers).

  1 Jackson SL, Tong X, King RJ et al. Circ Heart Fail. 2018 Dec; 11(12):e004873. doi: 10.1161/CIRCHEARTFAILURE.117.004873. PMID: 3056209.

  2 Costanzo MR, Ronco C, Abraham WT et al. J Am Coll Cardiol. 2017 May 16; 69(19): 2428–2445. doi: 10.1016/j.jacc.2017.03.528.

SAHARA and RED DESERT biomarker data hint to cardiorenal improvements with DSR therapy

Sequana presented recent analysis of the biomarker data from the previous RED DESERT and SAHARA studies using first-generation DSR (DSR 1.0) that gives insights into the mechanism of DSR and its potential use in CRS. As a reminder, the SAHARA top-line results showed that the DSR therapy can effectively manage fluid overload and restore euvolemia, improve diuretic response and resolve persistent congestion in diuretic-resistant CHF patients (patients who had persistent congestion despite taking maximum SoC loop diuretic therapy). SAHARA showed that the need for loop diuretic medication in CHF patients can be substantially reduced, and for a sustained period, following a first phase of intensive DSR therapy.

Following this intensive DSR therapy round, the diuretic response (in terms of both urinary output and urinary sodium excretion) following a diuretic challenge increased markedly versus baseline (pre-DSR treatment), and this improvement in response persisted for up to a year post the intensive DSR therapy round. As a result of a marked improvement in diuretic response, patients in SAHARA were able to significantly reduce the need for loop diuretics medication for at least six to 15 months following the DSR therapy phase of the study, with nine out of 10 evaluable SAHARA patients having had a reduction of more than 90% of their required dosing. Exhibit 1 shows the reduction in diuretic dose required over the 12 months post the intense therapy round.

Exhibit 1: Improvement in oral loop diuretic dose over 12 months of follow-up

Source: Sequana Medical presentation

The SAHARA trial demonstrated proof-of-concept that DSR can resolve persistent congestion in diuretic-resistant CHF patients, and the treatment led to lasting improvements in kidney function and cardiometabolic parameters. Importantly, all evaluable patients improved their New York Heart Association status by at least one class (in a four-class scale) and experienced no congestion-related hospital readmissions during the study.

Because of the complexity of CRS, biomarkers are important tools in assessing diagnosis, risk prediction and prognosis in patients with HF and impaired kidney function. Some of the most commonly used biomarkers are described below.

B-type natriuretic peptide (BNP) and N-terminal pro B-type natriuretic peptide (NT-proBNP): these biomarkers are often used to assess heart function. Elevated levels of BNP or NT-proBNP may indicate advancing heart failure.

CA125: a glycoprotein that is often associated with ovarian cancer and used as a tumour biomarker, it has also garnered interest for its potential use as a marker for fluid retention and inflammation in HF.

Serum creatinine: creatinine is a waste product that the kidneys normally filter out of the blood. Increased levels of serum creatinine can be a sign of kidney dysfunction.

Blood urea nitrogen (BUN): this is a measure of the amount of urea nitrogen in the blood. Urea nitrogen is normally filtered and excreted through the kidneys, and hence elevated amounts of BUN may indicate suboptimal kidney function.

Uremic toxins: these are biologically active metabolites or compounds that are retained in the bloodstream due to impaired kidney function. Examples include indoxyl sulphate, indol acetic acid, phenyl sulphate and p-cresyl sulphate hippuric acid.

More recently, Sequana reported additional biomarker data from the SAHARA and RED DESERT studies. When examining biomarkers NT-proBNP and CA125, which are barometers of cardiac stress due to volume overload and important for CRS, both SAHARA and RED DESERT showed statistically significant improvements in both parameters post-DSR therapy for up to at least five months. Similar improvements were also seen in the kidney function biomarkers: there was a sustained reduction of blood urea nitrogen and increase in creatine clearance, both indications of improved renal function, maintained up to 12 months post treatment. In addition, based on the overall kidney improvement function, the excretion of uremic toxin indoxyl sulphate improved and remained high until the end of the follow-up period.

In cardiovascular parameters, there was a significant improvement in the left ventricular ejection fraction in patients in both studies, with the responses maintained up to 12 months post treatment. With regard to systolic blood pressure, there was a transient increase in blood pressure (BP) during the active DSR treatment period, which normalised to baseline levels within five months following completion of this treatment round. The company interprets the transient BP increase as an indication that the Hawthorne effect (where study subjects modify their behaviour because they are aware they are being observed) can likely be ruled out as a meaningful factor in these studies. The reason why this effect is believed to be inconsequential is that the BP would not be expected to increase if the improvements in the other discussed clinical data points were strictly due to improved medication compliance (given that this medication is normally more likely to reduce BP rather than increase it).

Exhibit 2: Improvement in LV ejection fraction

Exhibit 3: Improvement is systolic blood pressure

Source: Sequana Medical

Source: Sequana Medical

Exhibit 2: Improvement in LV ejection fraction

Source: Sequana Medical

Exhibit 3: Improvement is systolic blood pressure

Source: Sequana Medical

Collectively, these biomarker results from the SAHARA and RED DESERT studies suggest that DSR treatment can not only reduce the need for loop diuretics but also result in sustained improvements of both cardiac and renal parameters. We note that the company has estimated, based on the Seattle Heart Failure Model, using post-hoc data, that at six weeks post an intensive DSR therapy round (as per Phase I of SAHARA and RED DESERT studies), subjects having completed the DSR therapy would have a c 75% lower predicted one-year mortality (c 5%) versus at screening (c 20%).

DSR 2.0 efficacy trends shown in early MOJAVE non-randomised cohort data

Sequana announced positive interim data from the two patients within the non-randomised cohort (total planned n=3) from the US Phase I/IIa MOJAVE study in patients with HF and severe diuretic resistance treated with DSR 2.0. Data from the first two patients from this cohort demonstrated that DSR 2.0 is safe and well tolerated and exhibits robust initial signs of efficacy. While the data are only from a small cohort of two patients, it is reassuring to see that US CHF patients treated with DSR 2.0 exhibit comparable responses to those seen in patients recruited in the Republic of Georgia and treated with DSR 1.0 in the SAHARA and RED DESERT trials. While the sample is extremely small, the interim data still provide an early indicator of an efficacy signal, highlighting the potential for DSR 2.0 in CHF as a potential disease-modifying therapy.

As a reminder, DSR 2.0 (a proprietary formulation of icodextrin and dextrose sugars) is designed to provide an improved therapeutic and a more favourable safety profile versus DSR 1.0. Further, we understand that an alternative sodium-free solution of icodextrin and dextrose is not commercially available for medical use. Compared to DSR 1.0, which is essentially a 10% dextrose solution, DSR 2.0 is designed to provide a longer dwelling time with slower sodium removal. Unlike in the RED DESERT and SAHARA studies, where DSR 1.0 was administered using an implanted alfapump device, DSR 2.0 is dosed through a peritoneal catheter. A key reason for this evolution in the DSR drug delivery approach was the observation of sustained and longer-term beneficial treatment effects following the DSR therapy treatment periods in the SAHARA and RED DESERT studies (and hence the implantation of a permanent alfapump device is no longer believed to be required in order to deliver persistent and lasting DSR-mediated treatment effects)

The MOJAVE Phase I/IIa study assesses the safety and efficacy of DSR 2.0 in diuretic-resistant CHF patients and consists of two groups: an open-label cohort with three patients receiving DSR 2.0 alongside optimised usual care for up to four weeks, and a randomised cohort where 20 patients will receive DSR 2.0 administered via a peritoneal dialysis (PD) catheter on top of optimised usual care for CHF for up to four weeks, and 10 patients randomised to receive intravenous loop diuretic treatment as part of maximised usual care for CHF. Both cohorts will have a three-month safety follow-up period after the four weeks of therapy.

Exhibit 4: Design of MOJAVE Phase I/IIa study

Source: Sequana Medical H123 presentation

Data from the first two patients showed comparable improvements in congestion management, diuretic response and cardiorenal status to those shown in RED DESERT and SAHARA. At the start of the study treatment period, loop diuretics were withheld and patients were treated with DSR 2.0 (up to once-daily doses) for four weeks. After the four-week treatment period, both patients maintained euvolemia without the need of loop diuretics and demonstrated improved cardiorenal status. Their diuretic response (as measured by six-hour excretion of sodium after IV administration of 40mg of furosemide diuretic) nearly normalised, with one patient showing a 712% increase in their six-hour urinary sodium excretion versus baseline, and the other showing a 195% increase. The interim data also showed a strong improvement in their kidney function, with an improvement in estimated glomerular filtration rate (eGFR) of 64% and 49% in the two patients and decreases of blood urea nitrogen of 65% and 52%.

No serious adverse events had occurred, indicating that DSR 2.0 was safe and well tolerated in these first two US patients, and both patients are currently in the follow-up period without any loop diuretics. The third patient in the non-randomised cohort has been enrolled and is expected to complete DSR treatment and initial follow-up before year-end. An independent Data and Safety Monitoring Board meeting is planned in Q124 to review the data from the three patients in the non-randomised cohort. If successful, the company plans to start the randomised cohort of the MOJAVE study in Q124. The company expects to report interim data from the randomised cohort in H224, followed by top-line data from this cohort in 2025.

Altogether, we believe the positive data from the first two patients in the non-randomised cohort are promising and provide very preliminary confirmation of the proof-of-concept shown in the SAHARA and RED DESERT studies, indicative of DSR 2.0’s potential as a disease-modifying CHF treatment.

POSEIDON 12-month data confirm continued efficacy

Sequana announced new 12-month positive data on the alfapump in RRA from the POSEIDON study, which were recently shared with the FDA as part of its pre-PMA discussions. As reported previously, the alfapump convincingly met the six-month primary efficacy endpoints. The first effectiveness endpoint is the median reduction in TP, where among the 40 patients, POSEIDON achieved 100% median reduction (p<0.001) in the post-implant observation period (reflecting months four to six) compared to the pre-implant observation period, while the study’s aim was to show at least a 50% reduction. For the second effectiveness endpoint, 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 three-month pre-implant observation period (p<0.001). The study’s aim was to show that at least 50% of patients achieve a 50% reduction in TP procedures.

The company has now reported that over the seven to 12 months following implantation versus the three month pre-implant period, 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. While two patients needed explantation over this period (one due to recurrent urinary tract infections and one due to wound dehiscence), this was within expectations given the high disease burden among recruited patients.

The rate of major adverse events and serious infections remained within anticipated levels, underscoring the device’s manageable safety profile during this extended follow-up. Additionally, patients maintained stable renal function, with creatinine and eGFR levels exhibiting no adverse changes.

Patients’ QoL also benefited from the alfapump. Their well-being was assessed using metrics like the SF36 physical component score and the Ascites-Q score, and despite the progression of their underlying condition (RRA), a meaningful improvement in their QoL was maintained at 12 months post-implant (vs three months pre-implant). Furthermore, the alfapump continued to demonstrate a favourable overall trend in survival. The Kaplan-Meier estimate suggested a survival probability of over 70% at both 12 and 18 months post-implant, which compares favourably to published literature citing a c 20%3 to 50%4 one-year survival rate for refractory ascites patients. Altogether, these findings underline the alfapump’s consistent ability to reduce paracentesis frequency and improve patients’ sense of well-being and QoL.

  3 Salerno F, Cammà C, Enea M et al. Gastroenterology. 2007 Sep;133(3):825-34. doi: 10.1053/j.gastro.2007.06.020. Epub 2007 Jun 20. PMID: 17678653

  4 Biggins et al., Hepatology, Vol. 74, No. 2, 2021, AASLD Practice Guidance; Moreau R et al., Liver International 2004: 24: 457-464

Altogether, while the new 12-month data were in line with our expectations, the data reinforce our confidence in a positive outcome from the PMA process. The company remains on track to file by the end of the year, and we continue to expect an FDA decision in H224.

Exhibit 5: QoL at 12 months maintained, despite disease progression

Exhibit 6: More than 70% survival at 12 and 18 months post-implant

Source: Sequana Medical

Source: Sequana Medical

Exhibit 5: QoL at 12 months maintained, despite disease progression

Source: Sequana Medical

Exhibit 6: More than 70% survival at 12 and 18 months post-implant

Source: Sequana Medical

NACSELD registry study supports safety profile

The North American Consortium for the Study of End Stage Liver Disease (NACSELD)-III registry is an institutional review board-approved outpatient cirrhosis registry established in 2019 among 10 tertiary-care hepatology centres in North America. A matched cohort analysis was performed by an independent entity with the goal of comparing outcomes of decompensated cirrhosis patients from the NACSELD-III registry to those from patients who participated in the POSEIDON study. Patients were matched based on the baseline Ascites-Q score (reflecting burden of disease) and gender; patients also were comparable for age and baseline MELD (model for end-stage liver disease) score after the matching. The analysis found that the proportions of all-cause hospitalisation and death within six months were similar between POSEIDON pivotal cohort patients and those from the NACSELD-III registry matched patients. For instance, the six-month data found that among the 40 matched NACSELD-III registry patients, the rates of any death or hospitalisation were similar to those found with the POSEIDON group (55.0%). A full data set is shown in the Exhibits 7 and 8.

Exhibit 7: NACSELD registry vs POSEIDON, baseline

Exhibit 8: NACSELD registry vs POSEIDON, 6 months

Source: Sequana Medical

Source: Sequana Medical

Exhibit 7: NACSELD registry vs POSEIDON, baseline

Source: Sequana Medical

Exhibit 8: NACSELD registry vs POSEIDON, 6 months

Source: Sequana Medical

The analysis confirmed that the safety profile of the alfapump is consistent with expectations and is comparable to RRA patients undergoing regular TP procedures. Altogether, the results suggest that patients implanted with the alfapump benefit from significantly reduced number of TP procedures (resulting in improved QoL) without an increased risk of death or hospitalisation compared to SoC. We believe this finding will further support Sequana’s upcoming PMA application, and this reinforces our confidence in a positive FDA decision (expected in H224).

Patient preference study supportive of market demand

The patient preference study was recommended by the FDA, to elicit patient preference attributes for using an implantable pump as treatment for RRA. The study was a survey (using discrete-choice experiment methodology, conducted by RTI Health Solutions) in 125 patients with physician-confirmed RRA due to liver cirrhosis. The purpose of the study was to determine what level of risk of treatment-related adverse events they would be willing to accept (ie risk tolerance) in order to achieve certain efficacy outcomes. Overall, the study confirmed that the surveyed US patients desired a reduction in TP, similar to what was reported in the POSEIDON study. Interestingly, the study also revealed that these US patients have a higher risk tolerance threshold compared to patients recruited in the POSEIDON study. In summary, we view these findings as encouraging and we believe they will be important for alfapump’s commercial uptake.

Exhibit 9: Patient preference study indicates compelling profile for alfapump

Source: Sequana Medical presentation

Financials and valuation

We leave our forecast assumptions unchanged and we continue to estimate that the company will require €130m in additional financing through the end of FY27 prior to reaching operating profitability (which we continue to anticipate in H128), including €35m before the end of FY24. As per our usual policy, we model all future fund-raising requirements as illustrative debt. We continue to assume that the company’s gross cash on hand (€17.1m at 30 June) will be sufficient for it to maintain operations into Q124.

The additional progress for the alfapump and DSR 2.0 programmes is encouraging, and we maintain our probabilities of success for alfapump and DSR 2.0 at 80% (for North America; 100% in Europe where it is already approved) and 25%, respectively.

We maintain our rNPV valuation of €359.5m. After adding €0.3m H123 net cash (€17.1m gross cash offset by €16.8m in H123 total debt, excluding €0.85m in lease liabilities), we obtain an equity valuation of €359.8m or €12.76/share (€11.64 fully diluted given options outstanding).

Exhibit 10: Sequana Medical rNPV assumptions

Product

Indication

Stage

NPV
(€m)

Probability of success

rNPV
(€m)

rNPV/ basic share (€)

Launch year

Sales in 2032 (€m)

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

Refractory and recurrent ascites and malignant ascites

Pivotal studying ongoing

275.4

80%

220.3

7.81

H224

195.2

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

Refractory and recurrent ascites and malignant ascites

Commercial/ marketed

(1.5)

100%

(1.5)

(0.05)

2013

1.0

DSR 2.0 (short-term DSR)

Fluid overload in heart failure

Human feasibility studies

852.2

25%

201.1

7.13

2028

356.9*

Corporate costs

(60.4)

100%

(60.4)

(2.14)

Total

1,065.6

359.5

12.75

Net cash (30 June 2023) excluding lease liabilities

0.3

0.3

0.01

Total equity value

1,066.0

359.8

12.76

Basic shares outstanding (000)

28,192

Outstanding warrants and share options (000)

2,722

Fully diluted shares outstanding (000)

30,914

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

As a sensitivity, our equity valuation per basic share would be adjusted to €5.95/share if we assume that total future funding need (€130m) is met through equity issuances at the current share price (c €2.69/share).

Exhibit 11: Financial summary

€000s

2018

2019

2020

2021

2022

2023e

2024e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

1,029

971

963

371

923

707

1,767

Cost of Sales

(158)

(198)

(202)

(77)

(205)

(153)

(353)

Gross Profit

871

773

761

294

718

554

1,414

General & Administrative

(8,206)

(7,102)

(6,738)

(7,177)

(8,927)

(9,822)

(14,480)

Net Research & Development

(5,816)

(7,652)

(11,835)

(16,935)

(20,416)

(21,157)

(17,250)

Operating profit before exceptionals

(13,150)

(13,981)

(17,813)

(23,818)

(28,625)

(30,426)

(30,317)

EBITDA

 

 

(13,070)

(13,737)

(17,506)

(23,409)

(28,313)

(29,889)

(29,662)

Depreciation & other

(81)

(244)

(307)

(409)

(312)

(537)

(654)

Operating Profit (before amort. and except.)

 

(13,150)

(13,981)

(17,813)

(23,818)

(28,625)

(30,426)

(30,317)

Exceptionals including asset impairment

74

18

41

1,205

530

0

0

Operating Profit

(13,077)

(13,964)

(17,771)

(22,613)

(28,095)

(30,426)

(30,317)

Net Interest

(883)

(878)

(1,178)

(608)

(2,282)

(1,377)

(2,738)

Profit Before Tax (norm)

 

 

(14,033)

(14,859)

(18,991)

(24,426)

(30,907)

(31,803)

(33,054)

Profit Before Tax (FRS 3)

 

 

(13,960)

(14,841)

(18,949)

(23,221)

(30,377)

(31,803)

(33,054)

Tax

(24)

(136)

(157)

(393)

(387)

(255)

0

Profit After Tax and minority interests (norm)

(14,057)

(14,995)

(19,148)

(24,819)

(31,294)

(32,059)

(33,054)

Profit After Tax and minority interests (FRS 3)

(13,983)

(14,977)

(19,106)

(23,614)

(30,764)

(32,059)

(33,054)

Average Number of Shares Outstanding (m)

10.0

12.3

15.3

18.2

22.8

28.2

28.2

EPS - normalised (€)

 

 

(1.41)

(1.22)

(1.25)

(1.36)

(1.37)

(1.14)

(1.17)

EPS - normalised and fully diluted (€)

 

 

(1.41)

(1.22)

(1.25)

(1.36)

(1.37)

(1.14)

(1.17)

EPS - (IFRS) (€)

 

 

(1.40)

(1.22)

(1.25)

(1.30)

(1.35)

(1.14)

(1.17)

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

242

829

772

1,814

2,936

2,963

2,731

Tangible Assets

184

765

705

1,732

2,850

2,875

2,644

Investments in long-term financial assets

58

63

67

82

86

88

88

Current Assets

 

 

3,099

8,522

13,441

12,890

23,089

1,938

4,478

Short-term investments

0

0

0

0

0

0

0

Cash

1,318

5,586

11,016

9,600

18,875

1,651

3,605

Other

1,782

2,935

2,425

3,290

4,214

287

873

Current Liabilities

 

 

(18,727)

(5,315)

(5,966)

(7,180)

(15,149)

(9,051)

(9,221)

Creditors

(6,654)

(4,855)

(5,966)

(7,180)

(10,666)

(6,169)

(6,339)

Short term borrowings

(12,073)

(459)

0

0

(4,483)

(2,882)

(2,882)

Long Term Liabilities

 

 

(3,374)

(3,110)

(8,135)

(8,312)

(13,030)

(14,867)

(49,867)

Long term borrowings

(2,582)

(2,261)

(7,473)

(7,325)

(12,193)

(13,909)

(48,909)

Other long term liabilities

(792)

(849)

(662)

(987)

(837)

(958)

(958)

Net Assets

 

 

(18,760)

926

113

(788)

(2,154)

(19,017)

(51,878)

CASH FLOW

Operating Cash Flow

 

 

(8,987)

(17,596)

(15,791)

(22,786)

(24,822)

(30,326)

(29,887)

Net interest and financing income (expense)

(883)

(878)

(1,178)

(608)

(2,282)

(1,377)

(2,738)

Tax

(5)

(9)

(36)

(222)

(378)

0

0

Net Operating Cash Flow

 

 

(9,875)

(18,482)

(17,005)

(23,616)

(27,482)

(31,704)

(32,624)

Capex

(39)

(106)

(138)

(326)

(677)

(210)

(423)

Acquisitions/disposals

0

0

0

0

0

0

0

Financing (net of costs)

2

26,165

19,000

22,771

28,420

15,780

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

(1,171)

261

(16,133)

(33,047)

Opening net debt/(cash)

 

 

0

13,337

(2,866)

(3,543)

(2,275)

(2,199)

15,140

HP finance leases initiated

0

0

0

0

0

0

0

Other

(3,425)

8,627

(1,179)

(97)

(337)

(1,206)

0

Closing net debt/(cash)

 

 

13,337

(2,866)

(3,543)

(2,275)

(2,199)

15,140

48,186

Lease debt

N/A

504

387

760

916

853

853

Closing net debt/(cash) inclusive of IFRS16 lease debt

13,337

(2,362)

(3,157)

(1,515)

(1,283)

15,992

49,039

Source: Company accounts, 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 2023 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

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 2023 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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