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, today announced that gross sales1 for the first half of 2024 totaled 2.4 million euros, up 8.8% over the same period last year. Gross sales do not include royalties receivable from partners for the first half.
In line with the Company's strategic plan, sales growth was sustainably driven mainly by Sibnayal® sales. The latter posted gross sales of 1.1 million euros, up 12.9% for the first six months of the year compared with the first half of 2023. In France, performance was solid, reflecting the strengthening of the sales and marketing team. In other European countries, Sibnayal® recorded several successes, but continued to be penalized by difficulties in gaining access to reimbursement. In addition, inventory effects in the first half of 2023 significantly limited growth in H1 2024. Likozam® and Levidcen® recorded sales of 1.0 and 0.3 million euros respectively.
Gross sales (m€) | H1 2024 | H1 2023 | Growth |
Sibnayal® | 1,08 | 0,96 | +12,9% |
Neurology of which Likozam® of which Levidcen® | 1,33 0,99 0,34 | 1,26 0,93 0,33 | +5,5% +6,5% +3% |
Total | 2,42 | 2,22 | +8,8% |
In the latest discussions between Advicenne and Primex International AG during this period, it became apparent that Primex is not in a position to honor all the commitments made in the contract signed in 2016 concerning the payment of royalties in 2025. In order to protect its interests, Advicenne is continuing discussions with Primex and hopes to reach a final agreement by the end of the year.
Finally, following the granting of orphan drug status for ADV7103 in cystinuria in April 2024 and an initial round of exchanges with the FDA on the basis of European clinical data in distal renal tubular acidosis, Advicenne is continuing its work over the summer to clarify the regulatory pathway for ADV7103 in the US in these indications. To this end, Advicenne enjoys the support of several key opinion leaders, both American and European, as well as patient associations.
At the date of this press release, the Company's cash flow horizon is Q1 2025.
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.
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1 Gross sales represent the gross amount invoiced to customers for the quantities of products delivered during the year. In countries where the price or reimbursement terms have not yet been set by the authorities, annual sales correspond to gross sales less taxes and rebates set by the regulatory authorities. These taxes and rebates are recorded on the basis of the company's best estimates, or the assessments received from the authorities.
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Contacts:
Advicenne
Didier Laurens, CEO
+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
