Advicenne: Fiscal year 2024 marked by the satisfactory commercial
performance of Sibnayal® in Europe and development in the
United States

• Total product sales of Advicenne up 9.4% to €4.9m
• Operating cash consumption below €1M by 2025 and significant improvement in cash
flow
• Cash position of €3.2 million on December 31, 2024, with a financing horizon of end-
June 2025
• European in-market sales of Sibnayal® up over 130% to €6.0M and royalties received in
excess of €0.5M
• Major regulatory advances for ADV7103 / Sibnayal® in the United States in its two
indications (dRTA and cystinuria)
• Favorable outlook with the filing of ADV7103 in dRTA in the United States, expected in
Q3 2025


Paris, France, March 27, 2025 – 6.30PM (CET) – Advicenne (Euronext Growth Paris ALDVI –
FR0013296746) a specialty pharmaceutical company dedicated to the development and
commercialization of innovative treatments for those suffering from rare renal diseases, announces
today its 2024 financial results, and provides an update on its activities.

The financial statements for the year 2024 were approved by the Board of Directors at its meeting on
March 27, 2025. The audit procedures are being finalized, and the auditors shall issue their audit report
by mid-April 2025. It will include a section on the significant going concern uncertainty related to the
financing of the Company's activities beyond June 2025. Advicenne has chosen to publish its financial
statements under French GAAP. As the company no longer publishes consolidated financial statements
since the closing of its US subsidiary in 2023, publication under IFRS is no longer relevant for Advicenne
SA's statutory financial statements. The 2024 financial statements under French GAAP will be available
in full in the Universal Registration Document 2024.

Didier Laurens, Chief Executive Officer of Advicenne, commented: “We are particularly pleased with
the performance of Sibnayal® in Europe, with in-market sales in excess of €6.0M, thanks to the
remarkable work of our team, our partners and the first patients treated outside Europe. Thanks to
these results, and to the appropriate allocation of our expenses, we were able to reduce our cash
consumption to less than €1 million for the year as a whole. Nevertheless, the year was marked by a
still restrictive pricing environment in Europe in general and in France in particular, which prevented us
from achieving our operating profitability target. Another positive result comes from the United States,
with the expected filing of the Nex Drug Application (NDA) for ADV7103 in dRTA in the third quarter of
2025, and the expected approval of the final development plan for cystinuria. These highly favorable
factors give us confidence in our ability to pursue and accelerate discussions with potential partners.
Finally, we are actively working to strengthen our financial resources, notably with our lenders, to
extend our cash horizon beyond the end of June 2025.”




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(€ thousands) December 31, 2024 December 31, 2023
Total product sales 4 877 4 458
Of which Sibnayal® 2 290 1 965
Revenue from partnerships 545 209
Current operating expenses 9 367 9 626
Of which Cost of Goods sold 2 699 1 725
of which R&D expenses 2 997 3 643
of which marketing and sales expenses 1 095 1 083
of which structural and general expenses 2 576 3 175
Current operating results -3 289 -4 628
of which pharmaceutical taxes 1 -2 878 -1 516
Impairment and other non-current items -2 537 0
Operating results -9 057 -6 473
Exceptional product 3 500 0
Financial results -1 266 -1 384
of which financial interests -1 289 -1 387
Net results -6 464 -7 528
Basic and Diluted loss per share (€/share) -0.53 -0.72

Opening cash 5 251 8 322
Cash flows from/(used in) operations -762 -6 041
Cash flows from/(used in) investing activities -108 -1 265
Cash flows from/(used in) financing activities -1 132 4 233
Closing cash 3 248 5 251


• 2024 key Financial highlights

Product sales reached 4.88 million euros in 2024, up 9.4% on 2023. Growth in gross sales was driven
mainly by Sibnayal®, which rose by almost 17% to 2.29 million euros. In France, performance was solid,
with an increase of 40% over the full year, and a marked acceleration in sales in the second half of
2024. In-market sales from partners in their respective markets reached 4.1 million in 2024. Thus, sales
of Sibnayal® in Europe and the Middle East totaled over 6.0 million euros, up by more than 130% on
2023. In addition to gross sales, Advicenne receives income from partnerships, based on the sales
generated by its partners. In 2024, Advicenne received 0.54 million euros from partnerships, compared
with 0.21 million euros in 2023.




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In France, where the price has not yet been mutually agreed with the administration, taxes set by the supervisory authorities
are paid to collecting bodies. These taxes are recorded based on the Company's best estimates or collections received from
the administration


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In-market sales Sibnayal® (m€) 2024 2023 Growth
France 1.82 1.30 40%
Europe & Middle-East 4.19 1.27 230%
Total 6.01 2.57 134%

In addition to gross sales, Advicenne receives income from partnerships, based on the sales generated
by its partners. In 2024, Advicenne received 0.54 million euros from partnerships, compared with 0.21
million euros in 2023.

The current operating loss for 2024 was reduced by almost 30% to -3.29 million euros, despite a step-
up in the cost of goods sold, marked by inventory effects. Current operating expenses, ex-COGS, fell
by more than 15% to 6.67 million euros (vs. 7.90 million euros in 2023). This improvement reflects the
ongoing strict allocation of resources to R&D and sales. R&D expenditure in 2024 was mainly allocated
to the development of ADV7103 in the United States.

In 2024, Advicenne recorded non-current charges of €5.31 million, including:
• a €2.88 million charge for pharmaceutical taxes set by the French health authorities in the
absence of an agreement on the health insurance reimbursement price for Sibnayal® and
Likozam®. This amount includes a catch-up on 2023 taxes,
• a charge of 2.53 million euros relating mostly to the total depreciation of a primary packaging
machine (bagging machine). The latest development work has confirmed the technical quality
of the machine, but the economic operating conditions justify the depreciation of this asset,
without calling into question the trajectory of Sibnayal® production cost reduction. These
charges include part of the acquisition costs of the machine and its pharmaceutical
development. This items has no impact on Advicenne's cash position.

Furthermore, Advicenne booked an exceptional product of 3.50 million euros linked to the conclusion
of the agreement with Primex Pharmaceuticals AG, a Swiss biopharmaceutical company, announced
in December 2024. Under this agreement, Advicenne received 1.75 million euros in December 2024,
with the balance to be received by mid-2026.

Financial losses came to €1.23 million, almost entirely represented by interest on the EIB loan and the
French State Guaranteed Loan (PGE), down slightly on 2023 due to lower royalties paid to the EIB.

The Company recorded a research tax credit of 0.38 million euros in 2024, compared with 0.32 million
euros in 2023.

Overall, net income showed a loss of 6.46 million euros, compared with 7.53 million euros in 2023.

Cash consumption from operations is 0.76 million euros in 2024, compared with 6.04 million euros in
2023, thanks to the agreement with Primex Pharmaceuticals AG. This agreement has also favored cash
flow, which continues its significant improvement to -2.97 million euros (vs. -6.46 million euros in
2023), by a factor of 3 in 3 years.

Investments in 2024 fell significantly following the decision to halt the development of the primary
packaging machine.




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In 2024, Advicenne has repaid 1.13 million euros of state guaranteed loan (PGE) principal to its lending
banks.

Finally, Advicenne ended 2024 with a net cash position of 3.25 million euros, compared with 5.25
million a year earlier. Excluding non-recurring items, this amount gives a cash horizon at the end of the
second quarter of 2025.


• 2024 highlights

Major regulatory progress for ADV7103 in the United States. The year 2024 was marked by significant
progress in the development of ADV7103 in the United States for both distal renal tubular acidosis
(dRTA) and cystinuria.

In dRTA, the Food and Drug Administration (FDA) has judged the European clinical data satisfactory for
an NDA without additional specific clinical studies in the United States. The FDA's positive opinion was
based on all the clinical data available in Europe, especially the one from the European pivotal study
(B21CS) and the long-term follow-up study (B22CS). Both provide clinical efficacy and safety data on
patients followed for over 6 years. Advicenne is actively working on finalizing the marketing
authorization application, including additional analyses of the natural history of patients and the
disease. Advicenne expects to file the NDA in the third quarter of 2025. ADV7103 has orphan drug
status in the dRTA indication in the United States.

In cystinuria, Advicenne has reached a key milestone with the FDA on the development plan for
ADV7103, as part of a renewed round of exchanges. Backed by preliminary clinical data, the support
of several American and European opinion leaders, and the International Cystinuria Foundation, the
leading cystinuria patient association, Advicenne has convinced the FDA to select a surrogate marker
that is easier to measure and more predictive of disease progression than a clinical endpoint such as
stones in the evaluation of ADV7103 in cystinuria. Advicenne is preparing to submit the final draft of
the pivotal study in this indication to the FDA. The choice of a biological primary endpoint should make
it possible to recruit patients in both the United States and Europe, and to consider filing applications
simultaneously in both regions.

In cystinuria, 2024 was also marked by the granting of orphan drug status for ADV7103 in the United
States.

Finalization of an agreement with Primex Pharmaceuticals AG. Advicenne has signed an agreement
with Primex Pharmaceuticals AG, a Swiss biopharmaceutical company. This agreement finalizes the
restructuring of contracts signed in 2016. Under this agreement, Advicenne will receive 3.5 million
euros, half of which already paid in December 2024; the balance will be received over the next 18
months. Advicenne is also eligible for additional amounts for commercial rights outside Europe.

• 2025 outlook: a pivotal year

Further growth in Sibnayal® sales. Advicenne expects sales of its main product, Sibnayal®, to grow in
Europe in 2025. Advicenne and its partners are committed to the continued commercial success of
Sibnayal®, which meets an important medical need.



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Filing of ADV7103 in the United States. The major objective is to file ADV7103 in the dRTA in the
United States during the third quarter. This will be a major step in creating value for the product and
for Advicenne. In parallel, Advicenne plans to finalize the development plan for ADV7103 in cystinuria.

Extending the cash horizon. Advicenne is actively working to extend its cash horizon beyond the first
half of 2025. Discussions with the Company's lenders, including the European Investment Bank, are
ongoing. The Company is also pursuing its efforts to finalize additional sources of financing through
the signature of a partnership around ADV7103 in the USA and outside Europe.


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ABOUT ADVICENNE

Advicenne (Euronext: ALDVI) is a specialty pharmaceutical company founded in 2007, specializing in the
development of innovative treatments in Nephrology. Its lead product Sibnayal® has received Marketing
Approval for distal renal tubular acidosis (dRTA) in EU and GB. ADV7103 is currently in late stage development in
cystinuria in Europe and in dRTA and cystinuria in the US and Canada. 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/.




CONTACTS


Advicenne Ulysse Communication
Didier Laurens, Directeur Général Media relations
+33 (0) 1 87 44 40 17 Bruno Arabian
Email : investors@advicenne.com +33 (0)6 87 88 47 26
Email : advicenne@ulysse-communication.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 2023 Universal Registration Document filed with the French financial market
authority on April 5, 2024 (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 not currently
considered material by Advicenne. The occurrence of all or part of such risks could cause actual results, financial


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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.




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