Advicenne publishes its annual financial results as of December 31, 2020 and confirms its 2021 outlook

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PARIS–(BUSINESS WIRE) – Regulatory news:

Advicenne (Paris: ADVIC) (BSE: ADVIC) (Euronext: ADVIC), a French company specializing in the development of therapeutic products suitable for children and adults for the treatment of orphan nephrological and neurological diseases, today publishes its 2020 financial results .

2020 HIGHLIGHTS

Scientific developments

On March 10, 2020, Advicenne was authorized to make ADV7103 available as part of a Temporary Authorization for Use (TAU) scheme set up by the National Agency for the Safety of Medicine and Health Products (National Agency for the Safety of Medicines and Health Products (ANSM)). This authorization allows the exceptional use of coated granules of 8 mEq and 24 mEq in sachets for the treatment of distal renal tubular acidosis (dRTA) in France. Its prescription is reserved for doctors specializing in nephrology.

On December 10, 2020, Advicenne received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending the approval of ADV7103 (Sibnayal®) as a treatment for renal tubular acidosis distal (dRTA) in Europe.

Legal developments

In May 2020, the Company created a subsidiary in the United States to manage its activity, in particular the clinical activity. Advicenne Inc. has started recruiting a team of US specialists to deploy the Company’s activities in this key market.

In addition, the governance of the company has evolved; following the separation of the functions of CEO and Chairman of the Board of Directors at the end of 2019, Dr André Ulmann was appointed Interim CEO on March 12, 2020, replacing Dr Luc-André Granier. Ms. Hege Hellstrom was appointed independent director at the general meeting of May 26, 2020.

Financial developments

As part of its financing agreement of 20 million euros with the European Investment Bank (EIB), Advicenne strengthened its financial structure by drawing a first tranche of 7.5 million euros; this tranche provides for a one-off repayment over 5 years.

The Company also obtained 4.3 million euros in additional financing within the framework of two loans guaranteed by the State for a maximum duration of 6 years.

EVENT SINCE END 2020

On February 15, 2021, Peter Meeus assumed the role of CEO of the Company, ending Dr. André Ulmann’s tenure as interim CEO.

OUTLOOK 2021

As specified in its press release of March 25, 2021, the Company expects European marketing approval for ADV7013 (Sibnayal®) by the end of the second quarter of 2021. It is currently in discussions with several partners regarding the commercialization. of this product in Europe during this fiscal year.

The clinical development of Sibnayal®, suspended due to the pandemic, continues with the resumption of the pivotal phase III trial of dRTA in the United States and the finalization of the protocols in the orphan indication of cystinuria in Europe and the United States -United.

KEY FINANCIAL DATA AT DECEMBER 31, 2020

The main financial data for fiscal year 2020 are presented in the table below: they are taken from the financial statements prepared in accordance with IFRS standards, as approved by the Board of Directors at its meeting of April 28, 2021. full financial statements will be available on the Company’s website: www.advicenne.com.

INCOME STATEMENT (in thousands of euros)

December 31, 2020

December 31, 2019

Returned

2,062

1,663

Other exploitation products

1,503

921

Total income and other income

3,564

2,584

Functionnary costs

-17,700

-16 832

Operating loss

-14,136

-14,248

Net loss

-14 846

-14,198

Loss per share (€ / share)

-1.76

-1.74

Diluted loss per share (€ / share)

-1.76

-1.74

2020 revenue increased by 25% compared to 2019. Sales for 2020 were mainly driven by Likozam® and Levidcen®, two licensed products for the treatment of epilepsy. Advicenne marketed these drugs in response to requests from hospital doctors for an alternative treatment for children with this disease.

Sales of the Company’s flagship drug candidate, ADV7103, under the European early access programs (EAP) or the Temporary Authorization for Use (TAU), totaled € 0.8 million in 2020, up by 60% (€ 0.3 million) compared to 2019.

The increase in operating costs in 2020 is mainly attributable to overhead costs.

Advicenne thus recorded a net loss of 14.8 million euros in 2020.

BALANCE SHEET (in thousands of euros)

December 31, 2020

December 31, 2019

Non-current assets

3 215

2 241

Current assets

20 789

21 638

of which cash and cash equivalents

16,771

16 629

Total assets

24,004

23 879

Total equity

3 272

16,720

Non-current liabilities

9 366

1,536

of which borrowings and financial debts

9,247

1,324

Current liabilities

11 366

5 623

of which borrowings and financial debts

4,550

288

of which trade payables

4,434

3,907

of which other current liabilities

2 383

1427

Total responsibilities

24,004

23 879

At the end of December 2020, the Company’s cash and cash equivalents were stable at 16.8 million euros. The financial debt takes into account the loan obtained from the European Investment Bank and loans guaranteed by the State for a total amount of 12 million euros.

CASH FLOWS (in thousands of euros)

December 31, 2020

December 31, 2019

Operating cash flow

-11,694

-9,475

of which cash flow

-13,592

-13,303

of which change in working capital requirement

1,898

3 828

Cash flow from investing activities

-694

-1 112

Cash flow from financing activities

12,529

983

of which change in loans and repayable advances

12,121

276

Cash change

142

-9,603

Cash opening

16 629

26 232

Closing liquidation

16,771

16 629

In 2020, cash flow from operating activities was negative at 11.7 million euros, due to the operating loss, partially offset by a positive impact of the working capital requirement.

Cash flow from investing activity mainly related to improvements to the ADV7103 packaging line in anticipation of the commercial launch of this product.

These flows were offset by a positive cash flow of 12.5 million euros from the financing activity, which includes the issue of bonds and a capital increase of 0.7 million euros continued upon the exercise of warrants.

The Company estimates that its current resources will enable it to finance its operations planned until October 2021, on the basis of the facts and assumptions detailed in note 4.3 “Business continuity” to the 2020 consolidated financial statements of the Company prepared. in accordance with IFRS. The Company is actively studying each option with a view to obtaining additional short-term financial resources.

The audit procedures have been completed and the auditor’s certification report is pending. It will include a note on significant uncertainties related to going concern beyond October 2021.

ABOUT ADVICENNE

Advicenne (Euronext: ADVIC) is a pharmaceutical company founded in 2007, specializing in the development of innovative treatments in nephrology. Its main drug candidate is currently in advanced clinical trials for two kidney diseases: renal tubular acidosis and cystinuria. ADV7103 recently received a positive opinion from the CHMP for the treatment of dRTA.

Based in Paris, Advicenne has been listed on the Euronext Paris stock exchange since 2017 and was listed on the Euronext Brussels stock exchange in 2019.

For more information see: www.advicenne.com

Forward-looking statements

This press release contains certain forward-looking statements relating to Advicenna’s business, which should not be construed in themselves as historical facts. These statements include projections and estimates, as well as the assumptions on which they are based, as well as observations relating to operations, projects in progress, objectives, product development and their future performance and expectations regarding the future. financial results.

In some cases, forward-looking statements may be identified by words such as “may”, “should”, “may”, “expects”, “anticipates”, “believes”, “intends”, “believes”. “,” Aims, “” targets “or similar words. Although the management of Advicenna believes that these forward-looking statements are reasonably worded, investors should be aware that they are subject to a number of risks and uncertainties known and unknown and to other factors that could cause actual results, performance or achievements to differ materially. any future results, performance or achievements expressed or implied by these forward-looking statements. In particular, expectations Advicenne could be affected, among other things, by uncertainties related to the marketing and marketing of Advicenne products or by any other risks and uncertainties developed or identified in any public document concerning submitted by Advicenne to 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 fairly 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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