- Significant regulatory and commercial progress for
SibnayalTM
- Control of expenses with a net loss reduced to €12.4 million
(vs. €14.8 million)
- Closing cash position at €12.7 million.
- Commercial launch of SibnayalTMin Europe expected in
2022.
Regulatory News:
Advicenne (Euronext: ALDVI) (Paris:ALDVI), a pharmaceutical
company specializing in the development and commercialization of
innovative treatments for those suffering from rare renal diseases,
today announces the publication of its financial results for the
year ended 31 December 2021 and provides an update on its
activities.
The audited financial statements for the year 2021 were approved
by the Board of Directors at its meeting on March 31, 2021.
Didier Laurens, Chief Executive Officer of Advicenne,
commented: "We are very pleased with the achievements in 2021,
which will no doubt be a springboard for our future success. During
the past year, SibnayalTM became the first treatment to obtain
marketing authorization in Europe and the United Kingdom for the
treatment of distal renal tubular acidosis (dRTA). In line with our
timetable, we signed our first commercial agreements at the end of
2021 in Europe, covering one-third of the European patients
affected with dRTA. In parallel we have made good progress with the
British and French health authorities (NHS and HAS) to market
SibnayalTM in optimal conditions for Advicenne. On the financial
front, our sales have increased by 20% while controlling our
expenses.
The year 2022 is indeed shaping up positively. We remain focused
on preparing for the commercial launch of SibnayalTM and to record
our first sales outside of any early availability regulatory
process. In parallel with the gradual ramp-up of SibnayalTM sales
through our distribution agreements with Frost Pharma, ExCEEd
Orphan and TwinPharma, we intend to continue the search for
partners in target areas both in and outside Europe. With the
appointment of a strong management team, we are confident that we
will be able to continue delivering on our strategy. Our objectives
remain clear and unchanged: continuing the launch of SibnayalTM,
pursuing its clinical development for the treatment of dRTA in the
United States, and for the treatment of cystinuria, while also
extending its indications to other renal diseases for which there
is no effective therapeutic solution.”
(€ thousands)
December 31, 2021
December 31, 2020
Total revenue and other income
3 766
3 564
Operating expenses
16 210
17 700
of which R&D expenses
8 964
8 146
of which marketing and sales expenses
1 569
3 827
of which structural and general
expenses
4 703
4 841
Operating loss
-12 444
-14 136
Net loss
-12 427
-14 846
Diluted loss per share (€/share)
-1,34
-1,76
Opening cash
16 771
16 629
Cash flows from operations
-12 525
-11 694
Cash flows from investing activities
-451
-694
Cash flows from financing activities
8 909
12 529
Closing cash
12 685
16 771
- Key financial Highlights (31/12/2021)
Operating income amounted to €3.8 million in 2021,
slightly higher (+5.7%) compared to previous year. Sales generated
by SibnayalTM, Likozam and Levidcen reached €3.3 million, up 20%
year-on-year. After considering rebates and provisions, accounting
revenues for 2021 were up nearly 30% to €2.7 million. In detail,
operating revenues also include the Research Tax Credit (“Crédit
Impôt Recherche”) for an amount of €1.1 million vs. €1.4 million in
2020. This decrease is explained by the transition of SibnayalTM
clinical development in Europe and the increase in R&D expenses
in the United States, which are not eligible for the CIR.
Current operating expenses were down 8.4% to €16.2
million (€17.7 million in 2020). R&D expenses increased to
reach about €9 million. During the year, Advicenne continued the
clinical development of ADV7103 and pursued the implementation of
Phase III studies in dRTA in the United States and in cystinuria in
Europe. Marketing and sales expenses were significantly reduced in
line with the promotion needs of Levidcen and Likozam. Finally,
general expenses amounted to €4.7 million, compared with €4.8
million in 2020. This decrease is the result of stronger control of
expenses incurred by the new management, offset by one-offs
following the implementation of the new management.
As a result, the Company recorded an operating loss of
€-12.4 million (€-14.1 million in 2020). In 2021, the Company
recorded a net financial product of €0.1 million, of which mostly
an interest charge of €1.0 million from both the €7.5 million
tranche of its loan from the EIB (European Investment Bank) and the
implementation of the French state-guaranteed loan (EMP). This has
been offset by revised valuation of the EIB debt of €1.2 million
according to IFRS standards. The Company did not record any
corporate income tax expense for fiscal year 2021.
Overall, net income showed a loss of €12.4 million
(compared with €-14.8 million euro in 2020). This loss represents
€1.34 euro per share in 2021 compared to €1.76 per share in
2020.
Net cash flow from operating activities amounts to €-12.5
million in 2021, compared to €-11.7 million in 2020. Cash flow from
operations improved significantly to €-11.8 million (vs. €-13.6
million in 2020). The sharp reduction in trade payables impacts the
WCR and consumes operating cash flow.
Net cash flow from investing activities amounts to €0.5
million and corresponds mainly to investments in production
operations.
Net cash flow from financing activities amounts to €8.9
million in 2021 of which €9.4 million gross proceeds from a capital
increase in June 2021.
Finally, Advicenne closed the year 2021 with a net cash
position of €12.7 million.
- Operational Highlights 2021
Registration and regulatory advances in Europe. Advicenne
has achieved important milestones during the year 2021. Last May,
SibnayalTM (ADV 7103), Advicenne's most advanced drug candidate,
was granted marketing authorization by the European Commission for
the treatment of distal renal tubular acidosis (dRTA) in adults,
adolescents and children aged one year and older. This was quickly
followed by the approval of SibnayalTM by the Medicines &
Healthcare products Regulatory Agency (MHRA) in the United Kingdom
in July 2021 for the treatment of dRTA in the same indication.
These authorizations have opened discussions with the health
authorities with a view to setting the price and conditions for
reimbursement of the drug. Thus, in France, the Haute Autorité de
Santé (HAS) validated last December the reimbursement of Sibnayal™
in its indication and assigned a level IV ASMR. Discussions are
underway to set the reimbursement price. In the United Kingdom,
after obtaining a list price from the National Health Service (NHS)
in December 2021, discussions are continuing to set the conditions
for reimbursement.
Strategic alliances. As expected, last year Advicenne
initiated the implementation of its strategy to commercialize
Sibnayal™ in Europe. The Company signed several exclusive
distribution partnerships covering the Benelux, Central and Eastern
European countries, and the Nordic countries. The three selected
partners (TwinPharma, ExCEEd Orphan, and FrostPharma AB) all work
within the exclusive European network, "Your Pharma Partner," whose
role is to make innovative therapies available to patients in 25
European countries. In total, these agreements cover approximately
one third of the European dRTA population. The Company is
continuing discussions with potential partners to cover other
geographical areas in Europe and beyond. Partners conduct local
negotiations with health authorities regarding pricing and
reimbursement. Sibnayal™ is available in post-ATU in France and 4
other European countries and approximately 100 patients are being
treated.
Clinical developments in the United States and Europe.
Advicenne continued the development of ADV7103 in dRTA in 2021 with
the initiation of a pivotal Phase III trial in the U.S. The primary
endpoints of the study have been validated by the U.S. Food and
Drug Administration (FDA). Advicenne is also pursuing the
development of ADV7103 in cystinuria. In this indication, urine
alkalinization remains the main objective of the treatment and
explains the interest of ADV7103 in twice-daily administration to
improve compliance.
Financial and managerial strengthening. In June 2021, the
Company strengthened its financial position through the completion
of a reserved capital increase of €9.4 million. This financing will
allow the Company to pursue the commercial, regulatory, and
clinical development of its lead drug. Advicenne's management team
has also been strengthened with the appointment of Didier Laurens
as Chief Executive Officer, as well as several high-level
executives in the areas of production, quality, and regulatory
affairs.
In fiscal year 2022, Advicenne expects to commercialize
Sibnayal™ in Europe and achieve its first sales outside the early
access setting. The Company also intends to enter new partnerships
in selected geographic areas. Advicenne plans to pursue the
clinical development of ADV7103 in the U.S in dTRA and in
cystinuria in Europe.
***
About Advicenne
Advicenne (Euronext: ALDVI) is a specialty pharmaceutical
company founded in 2007, specializing in the development of
innovative treatments in Nephrology. Its lead product SibnayalTM
(ADV 7103) has received its Marketing Approval for distal renal
tubular acidosis in EU and the UK. ADV 7103 is currently in
late-stage development in cystinuria in Europe and in dRTA and
cystinuria in the US and in Canada. Headquartered in Paris,
Advicenne has been listed on the Euronext Paris stock exchange
since 2017. For additional information see:
https://advicenne.com/.
Disclaimer
This press release contains certain forward-looking statements
concerning Advicenne group and its business, including its
prospects and product candidate development. Such forward-looking
statements are based on assumptions that Advicenne considers to be
reasonable. However, there can be no assurance that the estimates
contained in such forward-looking statements will be verified,
which estimates are subject to numerous risks including the risks
set forth in the 2020 universal registration document filed with
the French Financial market authority on December 6, 2021 under
number D.21-0962 (a copy of which is available on
www.advicenne.com) and to the development of economic conditions,
financial markets and the markets in which Advicenne operates. The
forward-looking statements contained in this press release are also
subject to risks not yet known to Advicenne or not currently
considered material by Advicenne. The occurrence of all or part of
such risks could cause actual results, financial conditions,
performance, or achievements of Advicenne to be materially
different from such forward-looking statements. Advicenne expressly
declines any obligation to update such forward-looking
statements.
Appendices
IFRS consolidated financial statements for
the year ended December 31, 2021
Balance Sheet
ASSETS
December 31, 2021
December 31, 2020
(in thousands of euros)
Intangible assets
167
38
Property, Plant and Equipment
1 836
2 785
Other financial assets
263
392
Non-current assets
2 265
3 215
Inventory
717
735
Accounts receivable
802
818
Tax credit
1 126
1 406
Other current assets
1 286
1 059
Cash and cash equivalents
12 685
16 771
Current assets
16 616
20 789
Total Assets
18 881
24 004
LIABILITIES and CAPITAL
December 30, 2021
December 31, 2020
(in thousands of euros)
Capital stock
1 990
1 724
Capital-related premiums
24 469
29 799
Reserves
-13 723
-13 404
Net Income
-12 427
-14 846
Total equity capital
309
3 272
Provisions
96
118
Long-term debt
12 371
9 247
Non-current liabilities
12 467
9 366
Financial liabilities
165
4 550
Accounts payable
2 929
4 434
Other current liabilities
3 012
2 383
Current liabilities
6 105
11 366
Total Liabilities
18 881
24 004
Income Statement
CONSOLIDATED INCOME STATEMENT
December 30, 2021
December 31, 2020
(in thousands of euros)
Revenues
2 670
2 062
Income from partnerships
19
73
Other operating income
1 078
1 430
Total revenue and other income
3 766
3 564
Cost of goods sold
-973
-886
Research and development expenses
-8 964
-8 146
Sales and marketing expenses
-1 569
-3 827
Overhead and general expenses
-4 703
-4 841
Operating Income
-12 444
-14 136
Net financing costs
139
-553
Other financial expenses
-148
-260
Other financial income
14
133
Income before taxes
-12 438
-14 136
Income taxes
11
-29
Consolidated net profit / loss
-12 427
-14 846
- Attributable to shareholders of
Advicenne SA
-12 427
-14 846
- Attributable to non-controlling
interests
-
-
Earnings per share (€/share)
-1,34
-1,76
Diluted earnings per share (€/share)
- 1,34
-1,76
Cash Flow Statement
CASH FLOW (in thousands of
EUR)
December 31, 2021
December 31, 2020
Net result (loss)
-12 427
-14 846
Amortisation, depreciation and
provisions
426
217
Share-based payments
347
605
Other calculated income and expenses
3
-122
Net financial costs
-139
553
Self-financing capacity
-11 782
-13 592
Changes in inventory
18
-239
Changes in trade and other receivables
296
1 035
Changes in trade and other payables
-1 057
1 102
Cash flow from operations
-12 525
-11 694
Acquisition of PPE and intangible
assets
-297
-575
Treasury shares
-56
-41
Acquisition of financial assets
-78
Disposal of financial assets
-98
Cash flow from investing
activities
-451
-694
Capital increase
9 088
662
Net borrowings and refundable advances
45
12 121
Repayment of borrowings and refundable
advances
-225
-254
Cash flow from financing
activities
8 909
12 529
Impact of changes in foreign exchange
rates
-18
Change in cash
142
142
Opening cash position
16 771
16 629
Closing cash position
12 685
16 771
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220331005815/en/
Advicenne Didier Laurens, CEO +33 (0)1 87 44 40 17 Email:
investors@advicenne.com
Consilium Strategic Communications Mary-Jane Elliott,
Ashley Tapp, Davide Salvi +44 (0)20 3709 5700 Email:
advicenne@consilium-comms.com
Ulysse Communication Media relations Bruno Arabian +33
(0)6 87 88 47 26 Email: barabian@ulysse-communication.com
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