Advicenne (Paris: ADVIC) (BSE: ADVIC) (Euronext Paris & Brussels: ADVIC - FR0013296746), a specialty pharmaceutical company focused on the development and commercialization of therapeutic products for rare kidney diseases, today announced its financial results for the year ended December 31, 2019 and confirmed its 2020 operational outlook.
2019 Highlights
2019 was a year of significant development for Advicenne as the company approaches the European commercialization of its lead drug candidate, ADV7103, in the treatment of distal renal tubular acidosis (dRTA). Preparations for the candidate's anticipated 2020 market launch, as well as ongoing Phase III clinical trials for dRTA in the United States and Canada, and for cystinuria in Europe, were the main investment items impacting the year's income statement.
Financial and Commercial Developments
In 2019, Advicenne has: Announced a successful cross-listing on the Euronext Brussels, making shares of the company available on the two largest Euronext markets in the life sciences sector.
Signed a financing agreement with the European Investment Bank (EIB) in the amount of EUR20 million, structured in three tranches of EUR7.5 million, EUR5 million and EUR7.5 million, respectively.
In another major step, Advicenne secured the commercial production of its lead drug candidate, ADV7103, through a long-term manufacturing supply agreement with Elaiapharm Lundbeck.
Scientific, Clinical and Regulatory Developments
Advicenne has also: Announced that it had received authorization from Belgium's Federal Agency for Medicines and Health Products (FAMHP) to begin a pivotal Phase II/III CORAL clinical trial for cystinuria with ADV7103.
Filed the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ADV7103 in the treatment of dRTA.
Announced the enrollment of the first patient in its United States pivotal Phase III Arena-2 clinical trial evaluating ADV7103 in the treatment of dRTA.
Presented additional European efficacy data on ADV7103 in the treatment of dRTA through oral and poster presentations at the 18th annual congress of the International Pediatric Nephrology Association (IPNA).
Announced that ADV7103 had been approved for orphan drug designation by the European Medicines Agency (EMA) for the treatment of cystinuria in Europe.
Corporate Governance and Oversight Developments
In 2019 Advicenne named Implid Audit a co-auditor in addition to KPMG, whose mandate was renewed. This choice was made in anticipation of the consolidation of accounts planned as part of the company's international deployment.
In the interest of corporate governance best practices, Advicenne separated the functions of Chief Executive Officer and Chairman of the Board of Directors, naming David Horn Solomon Chairman in an important step for the company's international strategy.
The company appointed Dr. Andre Ulmann interim CEO on March 12, 2020.
2020 and 2021 Outlook
For Advicenne, 2020 will primarily be devoted to preparing the European launch of ADV7103, whose application for marketing authorization is under review with the EMA's Committee for Medicinal Products for Human Use (CHMP). A decision is expected in 2020.
In 2020 Advicenne will also continue to pursue its investment in Phase III clinical trials in Europe, Canada and in the United States in the treatment of dRTA and cystinuria.
The company has also submitted its first requests for orphan drug designation in the United States.
Key Financial Data for 2019
The Advicenne Board of Directors met on March 12, 2020, under the chairmanship of David Horn Solomon, and approved the company's consolidated financial statements for the year ended December 31, 2019. Audit work has been undertaken by approved independent auditors whose report is ongoing.
About Advicenne
Advicenne (Euronext ADVIC) is a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for those suffering from rare kidney disease. Our lead drug candidate is currently in late-stage clinical trials for two indications.
ADV7103 was granted orphan drug designation by the European Commission in the treatment of Cystinuria in late 2019 and distal renal tubular acidosis (dRTA) in 2017, two rare renal diseases.
Cystinuria is a genetic disease characterized by cystine accumulation in the kidneys, leading to the recurrent formation of cystine stones.
dRTA is a serious condition that occurs when the kidneys are unable to effectively remove the buildup of circulating acids in the blood, resulting in metabolic imbalance.
In 2019, ADV7103 received the same designation for the treatment of cystinuria, a genetic disease characterized by a buildup of the amino acid cystine in the kidneys and bladder, leading to the recurrent formation of kidney stones, among other complications.
ADV7103 is currently in Phase III clinical trials for dRTA in the United States and Canada, and for cystinuria in Europe. In 2019, a European marketing authorization application for the drug candidate in the treatment of dRTA was submitted for centralized review.
At Advicenne, we are committed to innovating in the areas of formulation and dosage. Tasteless and easy to administer, our products are commercialized in small-size formats that offer flexible, personalized dosing - because path-breaking treatments for rare diseases should be available to patients of all ages.
Headquartered in Nimes, France, Advicenne has been listed on the Euronext Paris stock exchange since 2017 and was cross-listed on the Euronext Brussels stock exchange in 2019.
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 (Autorite des marches financiers (AMF)), including those listed in Chapter 4, 'Risk Factors,' of its reference document, filed with the latter on December 19, 2019, under number D.19-1036. 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.
Any information relating to the use of drug candidates contained in the present press release is based on the results of ongoing studies at the time of the release's publication. A drug candidate is a product that has not yet received marketing authorization from a health agency.
Contact:
Julie Rachline
Tel: +33 (0)4 66 05 54 20
Email: investors@advicenne.com
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