Disclaimer
The alfapump® system is currently not approved in Canada for commercial use. DSR® therapy is still in development and is currently not approved in the United States or Canada. Any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. Sequana Medical makes no claims of safety or effectiveness of the DSR® therapy in the U.S. or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.
PRESS RELEASE
REGULATED INFORMATION – INSIDE INFORMATION
18 March 2025, 07:00 CET
Ghent, Belgium – 18 March 2025 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces its financial results for the year ended 31 December 2024, and provides a business update and outlook for 2025 and beyond.
Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “2024 was a momentous year with US approval for the alfapump system – the result of many years of dedication and hard work by the entire Sequana Medical team. We believe that the alfapump has the potential to transform the treatment options for the US liver ascites community, who for too long have had to put up with a standard of care that dates back thousands of years. We are on track to commence sales in mid Q3 of this year through our own specialty salesforce that will target the 90 US liver transplant centers that we believe represents the large majority of our target patients and are highly encouraged by the strong interest seen from the doctors in the centers we are initially targeting.
We are excited by the publication in the European Journal of Heart Failure of our RED DESERT and SAHARA studies, highlighting DSR as a novel potential treatment for cardiorenal syndrome and diuretic resistance in heart failure. There is a clear need for better treatment options for congestive heart failure than loop diuretics that have well understood problems as well as widespread resistance, resulting in the very large number of hospitalizations and the huge cost to payers. With approval of the independent DSMB in hand, we look forward to commencing the randomized cohort of the US MOJAVE study
With the financing package that we announced today, comprising the continued support from existing investors, the share subscription facility from GEM and the extension to the repayments of our key loans, we expect our cash runway to be extended to the end of this year providing the opportunity to demonstrate the strong commercial interest we expect from our initial launch sites in the US.”
2024 highlights
US alfapump liver program
DSR heart failure program
Corporate
Post-period events
US alfapump liver program
Corporate
Outlook for 2025 and beyond
Detailed financial review
| in Thousand Euros (if not stated otherwise) | FY 2024 | FY 2023 | Change |
| Revenue | 106 | 712 | -85% |
| Cost of goods sold | (26) | (164) | -84% |
| Gross margin | 79 | 548 | -86% |
| Sales & Marketing | (1,058) | (1,799) | -41% |
| Clinical | (3,174) | (6,947) | -54% |
| Quality & Regulatory | (3,243) | (5,586) | -42% |
| Supply Chain | (3,315) | (4,724) | -30% |
| Engineering | (1,683) | (4,041) | -58% |
| General & Administration | (6,313) | (6,943) | -9% |
| Total operating expenses | (18,786) | (30,040) | -37% |
| Other income | 484 | 629 | -23% |
| Earnings before interest and taxes (EBIT[5]) | (18,223) | (28,862) | -37% |
| Finance income | 213 | 1,052 | -80% |
| Finance cost | (26,363) | (4,288) | 515% |
| Total net finance expense | (26,150) | (3,236) | 708% |
| Income tax expense | (280) | (466) | -40% |
| Net loss for the period | (44,654) | (32,564) | 37% |
| Basic Loss Per Share (in Euros) | (1.22) | (1.22) | 0% |
| Cash position* at 31 December | 3,807 | 2,584 | 47% |
* Cash position only includes cash and cash equivalents.
Consolidated statements of profit and loss
Revenue
Revenue decreased from €0.71 million in 2023 to €0.11 million in 2024 due to the decision to terminate European commercial activities in Q1 2024.
Cost of goods sold
Cost of goods sold decreased from €0.16 million in 2023 to €0.03 million in 2024, in line with the decrease in revenue.
Operating expenses
Total operating expenses decreased from €30.04 million in 2023 to €18.79 million in 2024, due to the measures taken to substantially reduce the cash burn in 2024.
Sales and marketing expenses decreased from €1.80 million in 2023 to €1.06 million in 2024 due to the decision to terminate European commercial activities in Q1 2024.
Clinical expenses decreased from €6.95 million in 2023 to €3.17 million in 2024 mainly as a result of lower costs related to the North American pivotal POSEIDON study of the alfapump and the decision to postpone the randomized phase of the MOJAVE DSR study in the US.
Quality and Regulatory expenses decreased from €5.59 million in 2023 to €3.24 million in 2024, mainly due to the measures taken to reduce cash burn in 2024 and higher expenses in 2023 for external advice solicited for the preparation of the submissions for marketing approval of the alfapump in the US.
Supply chain expenses decreased from €4.72 million in 2023 to €3.31 million in 2023 largely driven by the measures taken to reduce the cash burn in 2024 and higher spend in 2023 for additional staffing and external advice for the preparation of the submissions for marketing approval of the alfapump in the US.
Engineering expenses decreased from €4.04 million in 2023 to €1.68 million in 2024, largely driven by the measures taken to reduce the cash burn in 2024 and the one off costs for test samples in 2023 required for the preparation of the submissions for marketing approval of the alfapump in the US.
General and Administration expenses decreased from €6.94 million in 2023 to €6.31 million in 2024 largely driven by the measures taken to reduce the cash burn in 2024.
Other income remained broadly unchanged at €0.63 million in 2023 and €0.48 million in 2024 and includes recognized income from Belgian Research & Development (R&D) incentives with regard to incurred R&D expenses.
EBIT
As a result of the above, earnings before interest and taxes (EBIT) evolved from a loss of €28.86 million in 2023 to a loss of €18.22 million in 2024.
Total net finance expenses
Net finance cost increased from €3.24 million in 2023 to €26.15 million in 2024, mainly resulting from the fair value measurements of i) the Kreos Loan (most recently amended in 2024), ii) the September – December 2024 unsecured subordinated convertible loan agreements, and iii) the different subscription rights. All of these items are non-cash items.
Income tax expense
Income tax expense remained broadly unchanged at €0.28 million in 2024 and €0.47 million in 2023.
Net loss for the period
As a result of the above, the net loss increased from €32.56 million in 2023 to €44.65 million in 2024.
Basic losses per share (LPS)
Basic losses per share remained stable, from €1.22 in 2023 to €1.22 in 2024.
Consolidated balance sheet
Net debt
Net debt[6] at 31 December 2024 was €36.30 million, an increase of €21.37 million compared to 31 December 2023. The increase is mainly driven by (i) issuance of new convertible loans (September-December unsecured subordinated convertible loan agreements), and (ii) the fair value measurements of the Kreos Loan (most recently amended in 2024) and the September – December 2024 unsecured subordinated convertible loan agreements. These fair value measurements are non-cash items.
On 24 January 2025, Sensinnovat, Kreos and certain others converted some or all of their debt positions into equity of Sequana Medical NV for an amount of €4.50 million. Excluding this debt from the 31 December 2024 position, and assuming that all remaining September – December 2024 unsecured subordinated convertible loans convert, the remaining principal, accrued interest and fees at 31 December 2024 would have been €13.03 million.
Working Capital
Working capital[7] in 2024 dropped €1.44 million compared to 31 December 2023. The decrease is largely driven by measures taken to reduce cash burn in 2024.
Liquidity
Although the Company received approval for the alfapump from the US FDA, the Company still has to execute on its alfapump US commercialization strategy. Furthermore, DSR is still in its development phase and further clinical trials will be required to achieve regulatory marketing approvals. Both programs incur various risks and uncertainties, including but not limited to the uncertainty of the development & commercialization process and the timing of achieving profitability. The Company’s ability to continue operations also depends on its ability to raise additional capital and to refinance existing debt, in order to fund operations and assure the solvency of the Company until revenues reach a level to sustain positive cash flows.
The impact of macroeconomic conditions and geopolitical situation on the Company’s ability to secure additional financing rounds or undertake capital market transactions remains unclear at this point in time and will remain under review by the Executive Management and the Board of Directors.
The above conditions indicate the existence of material uncertainties, which may also cast significant doubt about the Company’s ability to continue as a going concern.
The Company will continue to require additional financing in the near future and in 2024 i) entered into a €3.0 million mandatory convertible loan agreement in February with Partners in Equity and Rosetta Capital, ii) successfully raised €11.5 million gross proceeds in March in a private equity placement via an accelerated bookbuild offering, iii) entered into several unsecured subordinated convertible loan agreements for a total amount of €7.6 million in Q3 and Q4. With the financing package announced today, comprising the €4.0 million unsecured subordinated convertible loan from existing investors, the GEM share subscription facility of up to €60 million and the extension to the repayments of key loans, the Company expects the net proceeds from these financings, based on the expected drawdown of the initial €20 million commitment of the share subscription facility, together with the existing cash resources to extend the current cash runway to the end of 2025. The Company continues to evaluate equity and other financing options, including discussions with existing as well as new investors.
The Executive Management and the Board of Directors remain confident about the strategic plan, which comprises additional financing measures including equity and/or other financing sources, and therefore consider the financial information in this press release on a going concern basis as appropriate.
Consolidated statement of cash flows
Net cash outflow from operating activities was €20.26 million in 2024 compared to €29.06 million in 2023. The lower outflow was driven by the measures taken in 2024 to reduce the cash burn.
Cash flow from investing activities resulted in a net outflow of €0.10 million in 2024, compared to a net outflow of €0.72 million in 2023.
Cash flow from financing activities resulted in a net inflow of €21.56 million in 2024, mainly as a result of the proceeds from the equity placement and the various convertible loan arrangements, partially compensated by repayments of financial debt and interest.
The Company ended 2024 with a total cash and cash equivalents amount of €3.81 million (2023: €2.58 million).
2025 Financial Calendar
22 April 2025 Online publication of Annual Report 2024
22 May 2025 Annual General Meeting 2025
For more information, please contact:
Sequana Medical
Investor Relations
T: +44 (0) 797 342 9917
About Sequana Medical
Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility. Although diuretics are standard of care, they become ineffective, intolerable or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing “diuretic resistant” patient population. alfapump® and DSR® are Sequana Medical’s proprietary platforms that work with the body to treat diuretic-resistant fluid overload, and are intended to deliver major clinical and quality of life benefits for patients, while reducing costs for healthcare systems.
The Company received US FDA approval for the alfapump System for the treatment of recurrent or refractory ascites due to liver cirrhosis in December 2024, following the grant of FDA Breakthrough Device Designation in 2019. Sequana Medical intends to start US commercialisation early in the second half of 2025 through a small specialty salesforce that it will establish to target the 90 US liver transplant centers that perform 95% of liver transplants.
Results of the Company’s RED DESERT and SAHARA proof-of-concept studies in heart failure published in European Journal of Heart Failure in April 2024 support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements[8].
Sequana Medical is listed on the regulated market of Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
Important Safety Information: For important safety information regarding the alfapump® system, see https://www.sequanamedical.com/wp-content/uploads/ISI.pdf.
The alfapump® System is currently not approved in Canada.
DSR® therapy is still in development and is currently not approved in any country. The safety and effectiveness of DSR® therapy has not been established.
Note: alfapump® and DSR® are registered trademarks.
Forward-looking statements
This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.
Financial information
The financial statements have been prepared in accordance with IFRS, as adopted by the EU. The financial information included in this press release is an extract from the full IFRS consolidated financial statements which will be published on 22 April 2025.
As of the date of this press release, the statutory auditor, PricewaterhouseCoopers Bedrijfsrevisoren BV, with registered office at Culliganlaan 5, 1831 Machelen, Belgium, represented by Peter D’hondt, auditor, has not yet completed his audit procedures on the IFRS consolidated statements as of and for the year ended 31 December 2024.
The statutory auditor has confirmed that the audit, which is substantially complete, has not to date revealed any material misstatement in the draft consolidated accounts, and that the accounting data reported in the press release is consistent, in all material respects, with the draft consolidated accounts from which it has been derived.
Consolidated statement of profit and loss
| in Thousand Euros (if not stated otherwise) | Year ended 31 December | |
| 2024 | 2023 | |
| Revenue | 106 | 712 |
| Cost of goods sold | (26) | (164) |
| Gross margin | 79 | 548 |
| Sales & Marketing | (1,058) | (1,799) |
| Clinical | (3,174) | (6,947) |
| Quality & Regulatory | (3,243) | (5,586) |
| Supply Chain | (3,315) | (4,724) |
| Engineering | (1,683) | (4,041) |
| General & Administration | (6,313) | (6,943) |
| Total operating expenses | (18,786) | (30,040) |
| Other income | 484 | 629 |
| Earnings before interests and taxes (EBIT) | (18,223) | (28,862) |
| Finance income | 213 | 1,052 |
| Finance cost | (26,363) | (4,288) |
| Total net finance expense | (26,150) | (3,236) |
| Income tax expense | (280) | (466) |
| Net loss for the period | (44,654) | (32,564) |
| Basic losses per share (in Euro) | (1.22) | (1.22) |
Consolidated statement of comprehensive income
| in Thousand Euros (if not stated otherwise) | Year ended 31 December | |
| 2024 | 2023 | |
| Net loss for the period | (44,654) | (32,564) |
| Components of other comprehensive income (OCI) items that will not be reclassified to profit or loss: | ||
| Remeasurements of defined benefit plans | (105) | (356) |
| Items that may be reclassified subsequently to profit or loss: | ||
| Currency translation adjustments | (34) | (64) |
| Total other comprehensive income/(loss)-net of tax | (138) | (420) |
| Total comprehensive income | (44,792) | (32,984) |
| Attributable to Sequana Medical shareholders | (44,792) | (32,984) |
Consolidated balance sheet
| in Thousand Euros (if not stated otherwise) | As at 31 December | |
| 2024 | 2023 | |
| ASSETS | ||
| Property, plant and equipment | 1,774 | 2,316 |
| Financial Assets | 104 | 100 |
| Other non-current assets | 1,649 | 1,388 |
| Total non-current assets | 3,527 | 3,805 |
| Trade receivables | – | 43 |
| Other receivables and prepaid expenses | 563 | 1,373 |
| Inventory | 2,046 | 2,296 |
| Cash and cash equivalents | 3,807 | 2,584 |
| Total current assets | 6,417 | 6,296 |
| Total assets | 9,944 | 10,101 |
| EQUITY AND LIABILITIES | ||
| Share capital | 4,604 | 2,926 |
| Share premium | 201,565 | 185,644 |
| Reserves | (721) | (2,896) |
| Loss brought forward | (250,676) | (206,022) |
| Cumulative translation adjustment | 849 | 882 |
| Total equity | (44,379) | (19,465) |
| Long term financial debts | – | 8,969 |
| Long term lease debts | 358 | 464 |
| Retirement benefit obligation | 754 | 668 |
| Total non-current liabilities | 1,112 | 10,101 |
| Short term financial debts | 39,698 | 7,818 |
| Short term lease debts | 55 | 269 |
| Other current financial liabilities | 7,387 | 2,767 |
| Trade payables and contract liabilities | 1,889 | 2,907 |
| Other payables | 1,693 | 2,257 |
| Accrued liabilities and provisions | 2,488 | 3,448 |
| Total current liabilities | 53,211 | 19,466 |
| Total equity and liabilities | 9,944 | 10,101 |
Consolidated statement of cash flows
| in Thousand Euros (if not stated otherwise) | Year ended 31 December | |
| 2024 | 2023 | |
| Net loss for the period | (44,654) | (32,564) |
| Income tax expense | 280 | 466 |
| Financial result | 26,203 | 3,271 |
| Depreciation | 615 | 661 |
| Change in defined benefit plan | (7) | (50) |
| Share-based compensation | (179) | 564 |
| Changes in trade and other receivables | 592 | (543) |
| Changes in inventories | 211 | 483 |
| Changes in trade and other payables/provisions | (2,948) | (905) |
| Taxes paid | (371) | (446) |
| Cash flow used in operating activities | (20,258) | (29,063) |
| Investments in tangible fixed assets | (95) | (711) |
| Investments in financial assets | (5) | (11) |
| Cash flow used in investing activities | (100) | (721) |
| Proceeds from capital increase | 11,665 | 15,786 |
| (Repayments) from leasing debts | (472) | (414) |
| (Repayments) from financial debts | (158) | (982) |
| Proceeds from financial debts | 10,682 | – |
| Interest paid | (162) | (929) |
| Cash flow from financing activities | 21,555 | 13,461 |
| Net change in cash and cash equivalents | 1,197 | (16,324) |
| Cash and cash equivalents at the beginning of the period | 2,584 | 18,875 |
| Net effect of currency translation on cash and cash equivalents | 26 | 33 |
| Cash and cash equivalents at the end of the period | 3,807 | 2,584 |
Consolidated statement of changes in equity
| in Thousand Euros (if not stated otherwise) | Share capital | Share premium | Reserves | Loss brought forward | Currency translation differences | Total shareholder equity |
| Balance at 1 January 2023 | 2,460 | 170,324 | (2,426) | (173,458) | 946 | (2,153) |
| Net loss for the period | (32,564) | (32,564) | ||||
| Other comprehensive income | (356) | (64) | (420) | |||
| April 2023 Equity Placement | 461 | 15,320 | 15,780 | |||
| Capital increase 10/23 | 5 | 0 | 6 | |||
| Transaction costs for equity instruments | (678) | (678) | ||||
| Share-based compensation | 564 | 564 | ||||
| Balance at 31 December 2023 | 2,926 | 185,644 | (2,896) | (206,022) | 882 | (19,465) |
| Balance at 1 January 2024 | 2,926 | 185,644 | (2,896) | (206,022) | 882 | (19,465) |
| Net loss for the period | (44,654) | (44,654) | ||||
| Other comprehensive income | (105) | (34) | (138) | |||
| March 2024 Equity Placement | 794 | 10,706 | 11,500 | |||
| Capital increase convertible loans to shares | 824 | 5,108 | 2,853 | 8,785 | ||
| Capital increases RSU and Retention shares | 59 | 106 | 165 | |||
| Transaction costs for equity instruments | (393) | (393) | ||||
| Share-based compensation | (179) | (179) | ||||
| Balance at 31 December 2024 | 4,604 | 201,565 | (721) | (250,676) | 849 | (44,379) |
[1] Based on US market assessment conducted by highly experienced international consulting group
[2] as defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q)
[3] Data on file; statements from “The Effects of alfapump on Ascites Control and Quality of Life in Patients with Cirrhosis and Recurrent or Refractory Ascites” American Journal of Gastroenterology [January 2025]
[4] Tan HK, James PD, Wong F. Albumin may prevent the morbidity of paracentesis-induced circulatory dysfunction in cirrhosis and refractory ascites: A pilot study. Dig Dis Sci 2016;61:3084-3092; b) Salerno F, Cammà C, Enea M, Rössle M, Wong F. Transjugular intrahepatic portosystemic shunt for refractory ascites: a meta-analysis of individual patient data. Gastroenterology 2007;133:825-834.
[5] EBIT is defined as revenue less cost of goods sold and operating expenses.
[6] Net debt is calculated by adding short-term, long-term financial and lease debt and deducting cash and cash equivalents
[7] The components of working capital are inventory + trade receivables + other receivables and prepaid expenses – trade payables – other payables – accrued liabilities and provisions.
[8] Data reported in press release of March 25, 2024; mean increase of 326% in six-hour urinary sodium excretion at 3 months follow up vs baseline, and 95% reduction of loop diuretics over same period
