PARIS–(COMMERCIAL THREAD) – Regulatory news:
Advicenne (Paris: ADVIC) (ESB: ADVIC) (Euronext: ADVIC), a specialist pharmaceutical company dedicated to the development and commercialization of innovative treatments for people with rare kidney diseases, today announces the publication of its half-year financial results ending June 30, 2021.
Key events – First half of 2021
On Sibnayal â„¢ / ADV 7103, Advicenne main product
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Received clearance from the European Commission to market Sibnayal â„¢ for the treatment of distal renal tubular acidosis (dTRA). The approval makes it the first and only drug approved by the label for the treatment of dRTA in adults, adolescents and children aged one year and older.
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Received Medicines & Healthcare products Regulatory Agency (MHRA) approval to market Sibnayal â„¢ in the UK for the treatment of dATR.
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Obtained US Food and Drug Administration (FDA) acceptance of the company’s modified protocol for the company’s US pivotal Phase III trial on Sibnayal â„¢ for the treatment of dATR.
On corporate governance and financing
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Carrying out a capital increase of 9.4 million euros to finance the continued clinical development of Sibnayal â„¢, its flagship product.
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Strengthening of the management team with the appointment of Mr. Didier Laurens as CEO.
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Define a new strategic vision, Advicenne 2.0, to maximize shareholder value. Under the new strategy, the first priority is to secure partnerships in Europe to generate commercial sales of Sibnayal â„¢ in dRTA. The second priority is to optimize the clinical development of Sibnayal â„¢ in the United States.
Key financial data
The financial results for the first half of 2021 are presented in accordance with IFRS rules. The results were approved on September 28, 2021 by the Board of Directors of the Company. The main financial data are presented in the tables below. The H1 2021 financial report is available on the Company’s website: www.advicenne.com.
|
REVENUE STATEMENT (in thousands of euros) |
June 30, 2021 |
June 30, 2020 |
|
Returned |
1,364 |
1,096 |
|
Other exploitation products |
383 |
523 |
|
Total income and other income |
1,746 |
1,619 |
|
Operating Expenses |
-9,293 |
-9 334 |
|
Operating loss |
-7 547 |
-7 715 |
|
Consolidated net income |
-7 990 |
-7,696 |
|
Earnings per share (€ / share) |
-0.93 |
-0.92 |
|
Diluted earnings per share (€ / share) |
-0.93 |
-0.92 |
|
BALANCE SHEET (in € K) |
June 30, 2021 |
December 31, 2020 |
|
|
|
|
|
Non-current assets |
3,200 |
3 215 |
|
|
|
|
|
Current assets |
20,925 |
20 789 |
|
of which cash and cash equivalents |
16,733 |
16,771 |
|
Total assets |
24,125 |
24,004 |
|
|
|
|
|
Total equity |
4,491 |
3 272 |
|
|
|
|
|
Non-current liabilities |
13 930 |
9 366 |
|
of which borrowings and financial debts |
13 848 |
9,247 |
|
Current liabilities |
5,705 |
11 367 |
|
of which borrowings and financial debts |
260 2,847 2,598 |
4,550 4,434 2383 |
|
Total responsibilities |
24,125 |
24,004 |
|
CASH FLOWS (in thousands of euros) |
June 30, 2021 |
June 30, 2020 |
|
|
|
|
|
Operating cash flow |
-8,527 |
-5,279 |
|
of which cash flow |
-7 185
-1 342 |
-7,147
1,418 |
|
Cash flow from investing activities |
-459 |
-473 |
|
|
|
|
|
Cash flow from financing activities |
8 948 |
7 398 |
|
of which capital increase |
9,089
– |
16
7,500 |
|
Change in cash |
-38 |
1,197 |
|
Checkout opening
Closing box |
16,771
16,733 |
16 628
17 825 |
About Advicenna
Advicenne (Euronext: ADVIC) is a specialized pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its flagship product SibnayalMT (ADV 7103) has received marketing authorization for distal renal tubular acidosis in the EU and UK. ADV 7103 is currently in advanced stages of development in cystinuria in Europe and in dRTA and cystinuria in the United States. Based in Paris, Advicenne has been listed on the Euronext Paris stock exchange since 2017 and was cross-listed on the Euronext Brussels stock exchange in 2019.
For more information, see: https://advicenne.com/
Forward-looking statements
This press release contains certain forward-looking statements relating to Advicenna’s business, which should not in themselves be regarded as historical facts. These statements include projections and estimates, and the assumptions on which they are based, as well as observations relating to operations, current projects, objectives, product development and future performance, and expectations regarding results. financial.
In some cases, forward-looking statements may be identified by words such as “could”, “should”, “could”, “expects”, “anticipates”, “believes”, “intends”, “Believes,” “aims,” ​​”targets,” or similar words. While management of Advicenna believes these forward-looking statements are reasonable, investors should be aware that they are subject to a number of risks and risks. known and unknown uncertainties and other factors which may cause actual results, performance or achievements to differ materially from future results, performance or achievements expressed or implied by these forward-looking statements. In particular, Advicenna’s expectations could be affected, among other things, by uncertainties related to the marketing and marketing of Advicenna’s products or by any other risk and uncertainty developed or identified in any public document filed by r Advicenne with the French financial markets. Authority (Financial Markets Authority (AMF)), including those listed in Chapter 4 “Risk factors†of its universal registration document, filed with the latter on December 22, 2020. Notwithstanding compliance with article 223-1 of the general regulations of the AMF (the information disclosed must be “accurate, precise and faithfully presented”), Advicenne disclaims any intention or obligation to update or publicly revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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