- 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
Regulatory News:
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.”
(€ 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.
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.
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.
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.
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.
⁂
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/.
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 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 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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250327471522/en/
Advicenne Didier Laurens, Directeur Général +33 (0) 1 87
44 40 17 Email : investors@advicenne.com
Ulysse Communication Media relations Bruno Arabian +33
(0)6 87 88 47 26 Email : advicenne@ulysse-communication.com
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