PARIS--(BUSINESS WIRE)--Regulatory News:
Advicenne (Paris:ADVIC) (BSE:ADVIC) (Euronext: ADVIC), a French company specialized in the development of therapeutic products adapted to children and adults for treating nephrological and neurological orphan diseases, today reported its 2020 financial results.
2020 HIGHLIGHTS
Scientific developments
On March 10, 2020, Advicenne was authorized to make ADV7103 available within the framework of a Temporary Authorization for Use (TAU) scheme established by France’s National Agency of Medicine and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé (ANSM)). This authorization allows the exceptional use of coated 8 mEq and 24 mEq granules in sachets for the treatment of distal renal tubular acidosis (dRTA) in France. Its prescription is reserved for physicians specializing in nephrology.
On December 10, 2020, Advicenne received a positive opinion from the CHMP (Committee for Medicinal Products for Human Use) of the European Medicines Agency recommending approval of ADV7103 (Sibnayal®) as therapy for distal renal tubular acidosis (dRTA) in Europe.
Legal developments
In May 2020, the Company created an affiliate in the United States to steer its activity, notably the clinical activity. Advicenne Inc. has begun recruiting a team of American specialists to deploy the Company’s activities in this key market.
Furthermore, the Company’s governance has evolved; following the separation of the functions of Chief Executive Officer and Chairman of the Board of Directors at the end of 2019, Dr. André Ulmann was appointed as Interim CEO on March 12, 2020, replacing Dr. Luc-André Granier. Mrs. Hege Hellstrom was appointed as an independent director at the general assembly of May 26, 2020.
Financial developments
Within the framework of its €20 million financing agreement with the European Investment Bank (EIB), Advicenne has strengthened its financial structure via the drawdown of a first tranche of €7.5 million; this tranche provides for a bullet repayment in 5 years.
The Company also obtained €4.3 million in additional financing within the framework of two State-Guaranteed Loans with a maturity of up to 6 years.
EVENT SINCE END-2020
On February 15, 2021, Peter Meeus assumed the position of the Company’s Chief Executive Officer, ending Dr. André Ulmann’s mandate as Interim CEO.
2021 OUTLOOK
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 talks with several partners regarding the marketing of this product in Europe during this financial year.
Sibnayal®’s clinical development, which had been suspended because of the pandemic, is continuing with the resumption of the pivotal Phase III trial for dRTA in the United States and the finalization of protocols in the cystinuria orphan indication in Europe and the United States.
KEY FINANCIAL DATA AT DECEMBER 31, 2020
The main financial data for the 2020 financial year are presented in the table below: they are taken from the financial statements drawn up under IFRS, as approved by the Board of Directors at its meeting of April 28, 2021. The full financial statements will be accessible on the Company’s website: www.advicenne.com.
INCOME STATEMENT (€ thousands) |
December 31, 2020 |
December 31, 2019 |
|
|
|
Revenue |
2,062 |
1,663 |
Other operating income |
1,503 |
921 |
|
|
|
Total revenue and other income |
3,564 |
2,584 |
|
|
|
Operating expenses |
-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 was up 25% compared with 2019. Sales recorded in 2020 were primarily driven by Likozam® and Levidcen®, two in-licensed products for treating epilepsy. Advicenne has marketed these drugs to meet hospital physicians’ requests for an alternative treatment for children suffering from this condition.
Sales of the Company’s lead drug candidate, ADV7103, within the framework of European Early Access programs (EAP) or French Temporary Authorization for Use (TAU), totaled €0.8 million in 2020, up 60% (€0.3 million) compared with 2019.
The increase in operating costs in 2020 was primarily attributable to structural costs.
Advicenne hence recorded a net loss of €14.8 million in 2020.
BALANCE SHEET (€ thousands) |
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 shareholders’ equity |
3,272 |
16,720 |
|
|
|
Non-current liabilities |
9,366 |
1,536 |
of which borrowings and financial debt |
9,247 |
1,324 |
|
|
|
Current liabilities |
11,366 |
5,623 |
of which borrowings and financial debt |
4,550 |
288 |
of which trade payables |
4,434 |
3,907 |
of which other current liabilities |
2,383 |
1,427 |
|
|
|
Total liabilities |
24,004 |
23,879 |
At the end of December 2020, the Company’s cash and cash equivalents were stable at €16.8 million. The financial debt takes into account the loan obtained from the European Investment Bank and the State-Guaranteed Loans for a total of €12 million.
CASH FLOW (€ thousands) |
December 31, 2020 |
December 31, 2019 |
|
|
|
|
|
|
Cash flow from operations |
-11,694 |
-9,475 |
|
|
|
of which self-financing capacity |
-13,592 |
-13,303 |
of which variation in working capital |
1,898 |
3,828 |
|
|
|
Cash flow from investing activities |
-694 |
-1,112 |
|
|
|
|
|
|
Cash flow from financing activities |
12,529 |
983 |
|
|
|
of which variation of borrowings and refundable advances |
12,121 |
276 |
|
|
|
Change in cash |
142 |
-9,603 |
|
|
|
Opening cash |
16,629 |
26,232 |
Closing cash |
16,771 |
16,629 |
In 2020, cash flow from operating activity was negative by €11.7 million, due to the operating loss, partially offset by a positive impact from working capital.
Cash flow from investment activity mainly related to improvements in the ADV7103 packaging line in anticipation of this product’s commercial launch.
These flows were offset by the positive €12.5 million in cash flow from financing activity, an amount that includes the issuance of bonds and a €0.7 million capital increase following the exercise of warrants.
The Company estimates that its current resources will enable it to finance its operations scheduled through to October 2021, based on the facts and assumptions detailed in note 4.3, “Business Continuity”, of the Appendix to the Company’s 2020 consolidated financial statements prepared in accordance with IFRS. The Company is actively looking into every option with a view to obtaining additional financial means in the short term.
Audit procedures have been completed and the statutory auditor’s certification report is pending. It will include a note on significant going concern uncertainties 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 lead drug candidate is currently in late-stage clinical trials for two kidney diseases: the renal tubular acidosis and cystinuria. ADV7103 has recently received a positive CHMP opinion for the treatment of dRTA.
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: 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 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.
