Regulatory News:
Advicenne (Paris:ADVIC) (BSE:ADVIC) (Euronext: ADVIC), a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for those suffering from rare renal diseases, today announces the publication of its financial results for the six months ending on June 30, 2021.
Key Events-- First Half 2021
On Sibnayal/ ADV 7103, lead Advicenne product
- Received authorization by the European Commission to market Sibnayal for the treatment of distal Renal Tubular Acidosis (dRTA). The approval makes it the first and only label-approved drug for the treatment of dRTA in adults, adolescents, and children aged one year and older.
- Received approval from the Medicines Healthcare products Regulatory Agency (MHRA) to market Sibnayal in the UK, for the treatment of dRTA.
- Received US Food and Drug Administration (FDA) acceptance of the amended protocol of the Company's US-based Phase III pivotal trial of Sibnayal for the treatment of dRTA.
On Corporate Governance and financing
- Successfully completed a capital increase of €9.4 million to finance the ongoing clinical development of Sibnayal, its lead product.
- Strengthened leadership team with the appointment of Mr Didier Laurens as CEO.
- Set out a new strategic vision, Advicenne 2.0, to maximize value for shareholders. Under the new strategy, the first priority is to secure partnerships in Europe to generate commercial sales of Sibnayal in dRTA. The second priority is to optimize the clinical development of Sibnayal in the US.
Key Financial Data
The H1 2021 financial results are reported according to IFRS rules. The results have been approved on September 28, 2021 by the Board of Directors of the Company. Key financial data are reported in tables below. The H1 2021 financial report is available on Company's website: www.advicenne.com.
INCOME STATEMENT (€ thousands) | June 30, 2021 | June 30, 2020 |
Revenue | 1 364 | 1 096 |
Other operating income | 383 | 523 |
Total revenue and other income | 1 746 | 1 619 |
Operating expenses | -9 293 | -9 334 |
Operating loss | -7 547 | -7 715 |
Consolidated net profit loss | -7 990 | -7 696 |
Earnings per share (€/share) | -0,93 | -0,92 |
Diluted earnings per share (€/share) | -0,93 | -0,92 |
BALANCE SHEET (en 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 shareholders' equity | 4 491 | 3 272 |
Non-current liabilities | 13 930 | 9 366 |
of which borrowings and financial debt | 13 848 | 9 247 |
Current liabilities | 5 705 | 11 367 |
of which borrowings and financial debt
| 260 2 847 2 598 | 4 550 4 434 2 383 |
Total liabilities | 24 125 | 24 004 |
CASH FLOW (€ thousands) | June 30, 2021 | June 30, 2020 |
Cash flow from operations | -8 527 | -5 279 |
of which self-financing capacity
| -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 |
Opening cash Closing cash | 16 771 16 733 | 16 628 17 825 |
About Advicenne
Advicenne (Euronext: ADVIC) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product SibnayalTM (ADV 7103) has received its Marketing Approval for distal renal tubular acidosis in EU and the UK. ADV 7103 is currently in late-stage development in cystinuria in Europe and in dRTA and cystinuria in the US. Headquartered 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 additional information see: https://advicenne.com/
Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Advicenne, which shall not be considered per se as historical facts. Such statements include projections and estimates, and the hypotheses on which these are based, as well as observations relating to operations, ongoing projects, objectives, the development of products and their future performance, and expectations regarding financial results.
In some cases, forward-looking statements can be identified by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets" or similar words. Although the management of Advicenne believes that these forward-looking statements are reasonably made, investors should be aware that they are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. In particular, the expectations of Advicenne could be affected by, among other things, uncertainties involved in the placing on the market and commercialization of Advicenne products or any other risks and uncertainties developed or identified in any public documents filed by Advicenne with the French Financial Markets Authority (Autorité des marchés financiers (AMF)), including those listed in Chapter 4, "Risk Factors," of its universal registration document, filed with the latter on December 22, 2020. Notwithstanding the compliance with article 223-1 of the General Regulation of the AMF (the information disclosed must be "accurate, precise and fairly presented"), Advicenne disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210929005478/en/
Contacts:
Advicenne
David Solomon, Chairman
Didier Laurens, CEO
+33 (0)4 66 05 54 20
Email: investors@advicenne.com
Consilium Strategic Communications
Mary-Jane Elliott, Ashley Tapp, Davide Salvi
+44 (0)20 3709 5700
Email: advicenne@consilium-comms.com
Ulysse Communication
Media relations
Bruno Arabian
+33 (0)6 87 88 47 26
Email: advicenne@ulysse-communication.com