NÎMES, France–(BUSINESS WIRE)–Regulatory News:
Advicenne (Paris:ADVIC) (Euronext: ADVIC – FR0013296746), a
pharmaceutical company specializing in the development of adult and
pediatric therapeutic products for the treatment of orphan renal and
neurological diseases, announces its financial results for the full year
ended December 31, 2018. The late-stage French biopharmaceutical company
also confirms its operational outlook for 2019.
2018 Highlights
-
European marketing authorization (AMM) granted for Ozalin®
(ADV6209), licensed to Primex Pharmaceuticals-
This approval allows Primex to commercialize Ozalin® in several
European countries. -
As provided for in the licensing agreement with Primex, the AMM
also triggered a second milestone payment of 3 million euros as
well as the definitive payment status of 2 million euros
previously accounted for as an advance received.
-
This approval allows Primex to commercialize Ozalin® in several
-
Significant clinical progress in the development of Advicenne’s
lead drug candidate, ADV7103-
The company received authorization from the French National Agency
for Medicines and Health Products Safety (Agence national de
sécurité du médicament et des produits de santé (ANSM)) to
begin pivotal Phase II/III CORAL trials of ADV7103 for the
treatment of cystinuria. -
Advicenne also announced preliminary results of the drug
candidate’s European Phase III extension study (B22CS) for the
treatment of distal renal tubular acidosis (dRTA): the open-label
clinical trial confirmed, after twenty-four months of treatment,
the positive B21CS study results. -
In North America, ADV7103 was granted investigational new drug
(IND) status by the U.S. Food and Drug Administration (FDA),
making it possible for the company to advance to pivotal Phase
II/III ARENA-2 trials for patients with dRTA in the United States. -
Also in North America, Advicenne received a No Objection Letter
(NOL) from the Health Canada Office of Clinical Trials, making it
possible to extend a pivotal Phase III ARENA-2 study of ADV7103
for patients with dRTA in Canada.
-
The company received authorization from the French National Agency
- Product sales grew 72% to reach 963,000€ net
-
Advicenne is poised for accelerated growth
-
The company’s staff grew 36% in 2018, with notable appointments
including:-
Dr. Linda Law, who will serve as U.S. Vice President of
Clinical Development and Medical Affairs, and who will
supervise clinical trials in the U.S. beginning in March -
Charlotte Sibley, who joined the Board of Directors as an
American Independent Director in September -
Paul Michalet, who was appointed to the post of Chief
Financial Officer, also in September
-
Dr. Linda Law, who will serve as U.S. Vice President of
-
Advicenne’s burn rate has stabilized, and a cash position
of 26.2 million euros on
December 31, 2018 – to which 3
million euros forthcoming from partner Primex Pharmaceuticals can
be added – offering the company a financial visibility of two
years.
-
The company’s staff grew 36% in 2018, with notable appointments
Recent Highlights
-
In January of 2019, Advicenne received authorization from the Belgian
health authority (FAMHP) to extend to Belgium its pivotal Phase II/III
CORAL clinical trial in cystinuria with its lead drug candidate,
ADV7103. -
In March of 2019, 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).
2019 Outlook
-
Accelerated recruitment for two pivotal studies of ADV7103 in:
-
Pivotal Phase II/III ARENA-2 trials for patients with dRTA (United
States). -
Pivotal Phase II/III CORAL trials for patients with cystinuria
(Europe).
-
Pivotal Phase II/III ARENA-2 trials for patients with dRTA (United
-
Preparation for commercial launch of ADV7103 in five European
countries (Germany, Spain, France, Italy, United Kingdom)
including the establishment of field structures and “market access”
initiatives. -
Conclusion of agreements for distribution outside these five
European countries -
Receipt of orphan designation for ADV7103 by regulatory authorities
in the United States (dRTA, cystinuria) and in Europe (cystinuria) -
Continued new product development with a goal of expanding the
company’s portfolio - Industrial and logistical deployment
Key Financial Data for 2018
The Advicenne Board of Directors met on March 20, 2019, under the
chairmanship of Dr. Luc-André Granier, and approved the company’s
consolidated financial statements for the year ended December 31, 2018.
Audit work has been completed by approved independent auditors whose
report is ongoing.
|
IFRS Income Statement |
||||
| INCOME STATEMENT (K€) | December 31, 2018 | December 31, 2017 | ||
| Revenue | 963 | 557 | ||
| Partnership revenue | 5,000 | 1,091 | ||
| Other operating revenue | 961 | 924 | ||
| Total revenue from current activity | 6,924 | 2,572 | ||
| Operating expenses | -12,216 | -8,546 | ||
| Operating loss | -5,292 | -5,974 | ||
| Net loss | -5,015 | -6,048 | ||
| Loss per share (€/share) | -0.62 | -1.01 | ||
| Diluted loss per share (€/share) | -0.62 | -1.01 | ||
Revenue in 2018 and 2017 was driven primarily by Likozam® and Levidcen®,
two in-licensed products for the treatment of epilepsy. Advicenne has
commercialized these medications in order to respond to the requests of
physicians for alternative treatments for children with epilepsy. In
2018, Advicenne began its first sales of ADV7103 on a temporary
authorization for use (ATU) basis.
Partnership revenue comprises milestone payments of 3 and 2 million
euros under an agreement signed with Primex Pharmaceuticals in February
2016. As noted above, these payments were made as a result of Ozalin®
having been granted European marketing authorization.
Other revenue derives from a research tax credit up to 0.8 million euros.
The increase in operating costs is due largely to investment in clinical
trials for ADV7103, in particular for the preparation and launch of the
pivotal Phase III ARENA-2 trials for patients with dRTA in the United
States, and the pivotal Phase III CORAL trials for a second indication,
cystinuria, in Europe. Costs incurred in the preparation for the
European commercial launch of ADV7103, as well as those relating to
Advicenne’s listing on Euronext, also contributed to the increase in
operational expenses.
|
IFRS Balance Sheet |
||||
| BALANCE SHEET (K€) | December 31, 2018 | December 31, 2017 | ||
| Non-current assets | 254 | 226 | ||
| Current assets | 32,585 | 38,308 | ||
| Cash and cash equivalents | 26,232 | 36,183 | ||
| Total assets | 32,839 | 38,533 | ||
| Total shareholders’ equity | 29,394 | 33,511 | ||
| Non-current liabilities | 321 | 560 | ||
| Borrowings and financial debt | 172 | 454 | ||
| Current liabilities | 3,123 | 4,463 | ||
| Loans and financial debt | 248 | 248 | ||
| Suppliers | 1,569 | 1,314 | ||
| Other current liabilities | 1,306 | 2,901 | ||
| Total liabilities | 32,839 | 38,533 | ||
At the close of 2018, Advicenne’s burn rate had stabilized, and the
company’s cash and cash equivalents were at 26.2 million euros, ensuring
strong financial visibility for two years.
|
IFRS Cash Flow Statement |
||||
| CASH FLOW (K€) | December 31, 2018 | December 31, 2017 | ||
| Cash flow from operating activities | -10,181 | -5,801 | ||
| Self-financing capacity | -4,484 | -5,032 | ||
| Variation in working capital | -5,697 | -769 | ||
| Cash flow from investing activities | -342 | -338 | ||
| Cash flow from financing activities | 571 | 40,739 | ||
| Capital increase | 744 | 40,830 | ||
| Changes in loans and repayable advances | – | 500 | ||
| Change in cash | -9,951 | 34,600 | ||
| Opening cash | 36,183 | 1,583 | ||
| Closing cash | 26,232 | 36,183 | ||
In 2018, cash flow from operations was negative 10.2 million euros. This
cash requirement can be explained by an operating loss and an increase
in working capital needs, of which a sum of 3 million euros remained
outstanding from Primex Pharmaceuticals on December 31, 2018, and by the
need to establish inventory to sustain anticipated growth.
Cash flow of 0.7 million euros connected to financing activities was
generated from the exercise of the over-allotment option following the
initial public offering in December 2017.
Paul Michalet, Chief Financial Officer, states: “We have
controlled our spending while maintaining our operational objectives. We
have good financial visibility and the trust of our partners should we
further accelerate our development.”
“2018 was a year of growth for Advicenne, in which we effectively
accomplished everything we announced at our initial public offering,” concludes
Dr. Luc-André Granier, Chief Executive Officer of Advicenne.
“Our positive results were unaffected during a difficult financial
period in which the market was disturbed by a considerable amount of bad
news. We will persevere despite such a climate because the current and
planned development of Advicenne makes it one of the most advanced
companies in the biotech sector, and also perhaps one of the least
risky. I have assembled an outstanding team of professionals that gives
me confidence in our trajectory.”
About Advicenne
Advicenne (Euronext: ADVIC) specializes in pediatric-friendly
therapeutics for the treatment of orphan renal and neurological
diseases. The French pharmaceutical company’s lead product, ADV7103, has
achieved positive results in Europe in a pivotal Phase III study of
distal Renal Tubular Acidosis (dRTA) in children and adults, leading to
its recent submission for European marketing authorization. The
commercial launch of ADV7103 in Europe is anticipated for late-2020.
In North America, ADV7103 has received clearance from the US FDA and
Health Canada for a pivotal Phase III clinical trial for the treatment
of dRTA patients. Commercial launch in the United States is anticipated
for 2021.
In addition to dRTA, ADV7103 is currently in Phase III clinical studies
for a second indication, cystinuria, an inherited renal tubulopathy.
Advicenne is listed on the Euronext Paris stock exchange (ISIN:
FR0013296746; Euronext ticker: ADVIC). Established in 2007, the company
is headquartered in Nîmes, France.
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 estimates for future
performance and estimates regarding anticipated operating losses, future
revenues, capital requirements and needs for additional financing. 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, they are based largely on the current expectations
of Advicenne as of the date of this press release and 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. 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.
Contacts
Advicenne
Luc-André Granier, Paul Michalet, Julie Rachline
E-mail:
investors@advicenne.com
+33
(0)4 66 05 54 20
Financial Communications
NewCap
Emmanuel Huynh & Alexia
Faure
E-mail: advicenne@newcap.eu
+33
(0)1 44 71 94 94
Press Relations
Alize RP
Caroline Carmagnol & Tatiana
Vieira
E-mail: advicenne@alizerp.com
+33
(0)1 44 54 36 66
US Investor Relations
Rx Communications Group, LLC
Paula
Schwartz
Email: pschwartz@rxir.com
+001
917-322-2216