Advicenne Announces 51% Growth in Sibnayal® Gross Sales in H1 2023 to almost €1.0 Million

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 sales reached 2.2 million euros for the first half of 2023, up 23% on the previous year.

For the first time, and in line with the Company's strategic plan, gross sales growth was mainly driven by Sibnayal® sales. Those posted a 128% increase in volume over the first six months of the year compared with the first half of 2022. In value terms, gross sales of Sibnayal® rose by 51% over the same period to 0.96 million euros (vs. 0.64 million euros in first-half 2022). Sibnayal® became the Group's leading product, ahead of Likozam® and Levidcen® with sales of 0.93 and 0.33 million euros respectively. Overall, gross sales for the Neurology franchise (Likozam® and Levidcen®) rose by more than 8% over the period.

The discrepancy between growth in value and volume is largely due to the implementation of partnerships and the transfer pricing structure. A more detailed analysis of sales shows an acceleration in half-yearly growth in both volume and value.

Didier Laurens, Chief Executive Officer of Advicenne, commented: "The first half of 2023 saw the implementation of our partnerships throughout Europe, and their first results. This first half is in line with our expectations, with more and more patients being treated across Europe and beyond; and very limited drop-out. It fits with our mission to meet unmet medical needs in rare diseases with drugs that significantly improve the daily lives of patients and their families.”

Sibnayal® achievements and prospects in Europe:

• Setting up marketing structures in the UK and France: these are beginning to bear fruit. In the UK, although negotiations with hospitals are taking time, several agreements with major hospitals were signed in the first half of the year, with more to follow in the second half. In France, the number of hospitals to be supplied has risen significantly, reflecting the growing distribution of the product across the country; to date, Sibnayal® has been delivered to 76 hospitals.

• Continued deployment of commercial partnerships in the rest of Europe: all partners, including the most recently signed, are now recording sales in their respective geographic zones, particularly in Germany, Denmark, and certain Eastern European countries. The first sales have also been recorded in the Middle East, thanks to the implementation of early access programs.

• First publication of long-term results for ADV7103 in the treatment of distal renal tubular acidosis (dRTA): presented at the European Renal Association congress in Milan, these 72-month follow-up results for patients treated with ADV7103 enabled European doctors specializing in rare kidney diseases to assess the benefits of the drug in this indication.

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® (ADV7103) has received its Marketing Approval for distal renal tubular acidosis in EU and GB. ADV7103 is currently in late-stage development in cystinuria in Europe and in dRTA and cystinuria in the US and in 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 2022 Universal Registration Document filed with the French financial market authority on April 28, 2023 (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 Gross sales correspond to the gross amount invoiced to customers for products that were delivered during the year. For countries where the price has not yet been agreed with Health Administration, the revenue for the year represents the Gross sales less rebates owed to Health Administrations. Such rebates are accrued based on the company’s best estimate and/or claims received from the administration.

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