Advicenne Presents 2019 Half-Year Financial Report and Confirms Financial Outlook

NÎMES, France--(BUSINESS WIRE)-- Regulatory News:

Advicenne (Paris:ADVIC) (BSE:ADVIC) (Euronext: ADVIC - FR0013296746), a specialty pharmaceutical company focused on the development and commercialization of therapeutic products for rare kidney disease, announces today its financial results for the six months ending on June 30, 2019, and confirms its operational outlook.

2019 Half-Year Highlights

• January 7: Advicenne received authorization from the Belgian health authority (Federal Agency for Medicines and Health Products (FAMHP)) to begin a pivotal Phase II/III CORAL clinical trial in cystinuria with its lead drug candidate, ADV7103
• March 12: The company submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for ADV7103 as a treatment for distal renal tubular acidosis (dRTA)
• June 12: Advicenne announced the successful listing of its shares on the Euronext Brussels regulated market
• June 13: The company confirmed prevalence rates of dRTA and cystinuria, presenting studies in three posters at the 2019 conference of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in New Orleans (USA)

Recent Highlights

• July 18: Advicenne announced the signing of a financing agreement in the amount of €20 million with the European Investment Bank (EIB) in 3 tranches of €7.5, €5 and €7.5 million, respectively
• August 30: The company announced the enrollment of the first patient in its US pivotal Phase II/III ARENA-2 clinical trial evaluating ADV7103 in the treatment of dRTA
• September 4: Advicenne announced the signing of a supply agreement with the pharmaceutical subcontractor Elaiapharm Lundbeck for the global manufacturing of ADV7103, with a view to its long-term commercialization
• September 20: The company announced that 8 new posters relating to its lead drug candidate will be presented at several major international nephrology conferences

Outlook

• In the second half of 2019 Advicenne continues investment in its imminent industrial and commercial phase, as well as in late-stage clinical trials currently being conducted in Europe, Canada and the United States
• The company remains confident that it will meet its short- and mid-term objectives, including obtaining orphan drug designation (ODD) for ADV7103 in the United States, and the expansion of its product portfolio

Key Financial Data for the First Half of 2019

The Advicenne Board of Directors met on September 23, 2019, under the chairmanship of Dr. Luc-André Granier and approved the company's half-year financial statements as of June 30, 2019. A limited review by approved independent auditors did not identify any accounting or presentation anomalies.

Income Statement

Revenue in the first half of 2019 rose to €757 thousand, or an increase of 72.8% relative to the first half of 2018. This revenue was driven primarily by Likozam® and Levidcen®, two in-licensed products for the treatment of epilepsy, as well as by sales of ADV7103 under temporary use authorization (TUA).

Other revenue derives from a research tax credit of €358 thousand.

The increase in operating costs is due largely to investment in clinical trials for ADV7103 in dRTA in the United States and in trials for cystinuria in Europe. The increase is also tied to preparations for the commercial launch of ADV7103 in Europe.

The increase in non-current assets, as well as the increase in borrowing and debt, in the amount of €1.2 million is a result of the application of norm IFRS16 which requires that leased assets be reported on the balance sheet. This increase has no bearing on the company’s cash position.

As of June 30, 2019, the company’s cash and cash equivalents amounted to €21.8 million. These resources, taken together with the non-dilutive financing in the amount of €20 million signed with the EIB at the beginning of July, provide Advicenne with the necessary financial resources for its continued development.

In the first half of 2019 cash flow from operations was negative €4 million due to an operating loss, partially offset by a €3 million milestone payment from Primex Pharmaceuticals.

“Our financial results as of June 30, 2019, are in keeping with the plan presented at our initial public offering,” affirms Paul Michalet, Chief Financial Officer of Advicenne, “and we have been able to limit our cash consumption during this period, all the while dynamically pursuing our development.”

“The first half of 2019 was marked by several strategic achievements,” adds Dr. Luc-André Granier, Co-founder et Chief Executive Officer of Advicenne, “such as the submission of a marketing authorization application (MAA) for ADV7103 in Europe, the cross-listing of our shares on the Euronext Brussels and, more recently, the establishment of a manufacturing agreement with our historical partner Elaiapharm Lundbeck. Our solid cash position will allow us to take the coming steps in Advicenne’s industrial and commercial deployment strategy with ease.”

About Advicenne

Advicenne (Euronext - ADVIC) is 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.

In 2017, ADV7103 was granted orphan drug designation by the European Commission in the treatment of distal renal tubular acidosis (dRTA), a rare kidney disorder that occurs when the kidneys are unable to effectively remove the buildup of circulating acids in the blood. ADV7103 is currently in Phase III clinical trials for this indication in Europe, the United States and Canada, and a marketing application for the drug candidate has been submitted for centralized European review.

While we prepare its European commercial launch for dRTA, we are simultaneously conducting trials for ADV7103 in the treatment of cystinuria, a genetic disease characterized by a buildup of the amino acid cystine in the kidneys and bladder. ADV7103’s Phase II/III European clinical trials for this second indication were recently expanded to Belgium.

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 Nîmes, 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.

www.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 reference document, filed with the latter on December 3, 2018, under number R.18-073, and in Section 8 of its annual financial report published on April 30, 2019. 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.

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Advicenne

Luc-André Granier, Paul Michalet, Julie Rachline
E-mail: [email protected]

+33 (0)4 66 05 54 20

Financial Communications

NewCap

Emmanuel Huynh & Alexia Faure
E-mail: [email protected]

+33 (0)1 44 71 94 94

Press Relations

Alize RP

Caroline Carmagnol

E-mail: [email protected]

+33 (0)6 64 18 99 59

US Investor Relations

Rx Communications Group, LLC

Paula Schwartz
Email: [email protected]

+001 917-322-2216

Source: Advicenne