-- Sibnayal(R) end-market sales (Europe and Middle East) up 27% to EUR6.6
million, with royalties received increasing 45% to EUR0.54 million.
-- Positive half-year net result of EUR4.6 million, compared with a net
loss of EUR4.9 million in the first half of 2025.
-- Net debt reduced by nearly EUR6.0 million following the pricing
agreement for Likozam(R) on the French market.
-- Cash position of EUR1.55 million and financial visibility extended into
the second quarter of 2027, supported by a bond financing facility of up
to EUR3.8 million.
-- Post-closing events:
-- Reimbursement approval for Sibnayal(R) in Spain
-- Withdrawal of the marketing authorization application for
ADV7103 in the United States
PARIS--(BUSINESS WIRE)--September 17, 2026--
Regulatory News:
Advicenne (Euronext Growth Paris - FR0013296746 - ALDVI), a pharmaceutical company specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases, today reports its 2026 first half financial results, as approved on September 17, 2026, by the Board of Directors. The first half financial report is available on the Company's website: www.advicenne.com.
Didier Laurens, Chief Executive Officer of Advicenne, commented: << The first half of fiscal year 2026 was marked by very significant developments, chief among them the long-awaited conclusion of price negotiations for Sibnayal(R) and Likozam(R) in France. Therefore, these agreements drove a significant increase in sales of both products in France. This success has also enabled us to reduce our debt by approximately EUR6.0 million and to report a positive net result for the first time in Advicenne's history. Regarding in the United States, following the withdrawal of the registration application, we are assessing the various options available to us to create maximum value for ADV7103 and are continuing discussions with potential partners, who do not appear to be discouraged by this episode".
Highlights of 2026 Half-year financials
An extract from the 2026 half-year financial statements prepared in accordance with French standards, as approved by the Board of Directors, is presented below. Audit procedures were carried out by the Statutory Auditors, who, following a limited review, did not identify any material accounting or presentation anomalies. The complete financial statements and notes are available in the Half-Year Financial Report.
(in KEUR) June 30, 2026 June 30, 2025
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Total revenues(1) 2 919 2 782
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Partnership revenue 539 372
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Revenue from ordinary activities 3 696 3 260
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Current operating expenses 5 308 5 167
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Costs of goods sold 2 007 1 507
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R&D expenses 1 868 2 016
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Sales & marketing expenses 232 322
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G&A expenses 1 202 1 322
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Current operating result -1 612 -1 907
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Pharmaceutical taxes 5 989 -2 256
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Depreciation and other non-recurring expenses 1 112 -112
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Operating income 5 490 -4 276
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Financial result -872 -683
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including financial interests -884 -653
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Net income 4 618 -4 957
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Earnings per share (EUR/share) 0,32 -0,40
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Opening cash & cash equivalent (as of Dec 31(st)
) 1 345 3 248
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Closing cash & cash equivalent 1 549 515
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-- Product sales amounted to EUR2.92 million in the first half of the
current fiscal year, up 5% compared with the first six months of 2025.
These sales were driven by accelerating volume growth for Sibnayal(R) and
Likozam(R) in France--up 41% and 13%, respectively. These results reflect
the impact of improved patient access to these treatments in France. This
strong performance was offset by the price reduction for Sibnayal(R)
agreed upon as part of the transition out of the early access program.
-- Total revenues from ordinary activities amounted to EUR3.70 million for
the period, up 13% compared to the first half of 2025. This marked
increase is driven by significant growth in product sales and royalties
received from Sibnayal(R) distributors in Europe and the Middle East,
with total revenues reaching EUR6.6 million for the first half of
2026--up 27% compared to the first half of 2025.
-- The current operating loss amounted to EUR1.61 million for the period
compared with a loss of EUR1.91 million a year earlier. This improvement
is driven by revenue growth and a slight reduction in R&D spending
related to the ADV 7103 project in the United States. Cost of sales has
risen due to inventory build-up to support the continued growth in sales
volumes for Sibnayal(R) and Likozam(R). Overhead costs have continued the
steady decline observed over several fiscal years.
-- Operating income stands at EUR5.49 million. It benefits from two
significant factors: 1) the reversal of a EUR1.3 million provision
established upon the launch of the Likozam(R) early access program in
2017 (this provision covered the period up to July 2021); and 2)
compensation for Likozam(R) early access rebates following the pricing
agreement reached in May 2026.
-- Net profit for the first half of 2026 stood at EUR4.61 million,
compared to a loss of EUR4.96 million a year earlier. This turnaround is
attributable to the recognition of non-recurring items related to the
reimbursement of Likozam(R) and Sibnayal(R) in France. Net profit is also
impacted by financial losses of EUR0.87 million as of June 30, 2026 (vs.
losses of EUR0.68 million in H1 2025), impacted by the rise in royalty
and interest rates resulting from the debt restructuring agreements
concluded in July 2025.
-- Net debt decreased by nearly EUR6 million to EUR25.5 million, driven by
the offsetting of debts related to early access in France in connection
with the pricing agreement for Likozam(R) and Sibnayal(R).
-- As of June 30, 2026, Advicenne reports cash & equivalents of EUR1.55
million. Following a bond financing arrangement with a nominal value of
up to EUR3.8 million--concluded in June 2026--and the immediate receipt
of EUR1.4 million in net proceeds thereunder, Advicenne has financial
visibility extending to the second quarter of 2027 as of the date of this
document. These resources are sufficient to cover the observation period
of the safeguard proceedings.
Highlights of the first half of 2026
Continued business development in Europe and the Middle East
In Europe, Sibnayal(R) sales in its end markets totaled EUR6.6 million, a 27% increase compared to the same period in 2025. This growth is reflected in a steady rise in royalties recorded in the first half of 2026, which increased by 45% to EUR0.54 million. These results demonstrate the continued growth in the number of patients treated, confirming the product's established role in patient care.
Opening of safeguard proceedings
-- On May 5, 2026, Advicenne announced the initiation of safeguard
proceedings aimed at restructuring all its debt. The finalization of
pricing agreements for Likozam(R) last May has already made it possible
to offset a sizable portion of Advicenne's social liabilities.
-- The observation period runs until November 5, 2026, and may be extended
until May 6, 2027.
Post-closing events
Voluntary withdrawal of the marketing authorization application for ADV7103 in the United States
-- In August 2026, the Company decided to withdraw the registration
application for ADV7103 in North America. This decision was driven by the
need for additional work in the CMC (Chemistry, Manufacturing and
Controls) area, which could not be completed within the timeframe of the
ongoing review.
-- To date, Advicenne continues discussions with potential partners.
In Spain, Sibnayal(R) is now reimbursed, following many years of discussions with Spanish health authorities.
Outlook for the second half of 2026
For the second half of the 2026 fiscal year, Advicenne anticipates continued strong sales growth in both Europe and the Middle East, as well as a significant reduction in operating expenses.
A key milestone in the safeguard procedure is expected with the conclusion of the six-month observation period next November.
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About Advicenne
Advicenne (Euronext Growth Paris ALDVI - FR0013296746) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product Sibnayal(R) (ADV7103) has received its Marketing Approval for distal Renal Tubular Acidosis (dRTA) in EU, the UK, KSA and UAE, and is marketed in more than twenty-five countries in Europe. Headquartered in Paris, Advicenne, listed on the Euronext Paris stock exchange since 2017, has now been listed on Euronext Growth Paris since its transfer on March 30, 2022. For additional information, see: https://advicenne.com/.
Disclaimer
This press release contains certain forward-looking statements concerning Advicenne group and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Advicenne considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the 2025 Universal Registration Document filed with the French financial market authority on April 26, 2026 (a copy of which is available on www.advicenne.com) and to the development of economic conditions, financial markets and the markets in which Advicenne operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Advicenne or currently not considered material by Advicenne. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Advicenne to be materially different from such forward-looking statements. Advicenne expressly declines any obligation to update such forward-looking statements.
(1) Excluding non-recurring items of EUR1.3 million corresponding to the reversal of provisions set aside for "early access" programs.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260917527890/en/
CONTACT: Advicenne
Didier Laurens, Chairman and CEO
+33 (0) 1 87 44 40 17
Email: investors@advicenne.com
Maarc -- Media relations
Bruno Arabian
+33 (0)6 87 88 47 26
Email: bruno.arabian@maarc.fr