Nicox Provides First Half 2023 and Third Quarter 2023 Financial Results and Updates Key Milestones
20 Octobre 2023 - 7:30AM
Nicox Provides First Half 2023 and Third Quarter 2023 Financial
Results and Updates Key Milestones
Press Release |
Nicox Provides First Half 2023 and Third Quarter 2023 Financial
Results and Updates Key Milestones |
- Third quarter 2023 U.S.
prescriptions for VYZULTA®
increased by 22% over third quarter
2022
- NCX 470 Phase 3 Denali
clinical trial over 65% randomized
- Net revenue €1.7 million for
first half 2023 and €1.1 million for third quarter
2023
- Cash of €14.6 million on
September 30, 2023
October 20, 2023 – release at 7:30 am CET Sophia Antipolis,
FranceNicox SA (Euronext Paris: FR0013018124,
ALCOX), an international ophthalmology company, today provided
financial results for Nicox SA and its subsidiaries (the “Nicox
Group”) for the first half of 2023 and for the third quarter of
2023 and provided an update on key future milestones.“The NCX 470
Denali trial is on track to report data in 2025, with over 65% of
the target number of patients randomized in the trial. NCX 470, a
novel nitric oxide donating bimatoprost eyedrop, is our lead
clinical asset and earlier this year we announced that potential
annual global peak net sales of NCX 470, based on the profile from
the first Phase 3 trial Mont Blanc, could exceed $300 million.”
said Andreas Segerros, Chief Executive Officer of
Nicox. “In parallel with the progress of the Denali trial,
and the upcoming commercial launch of ZERVIATE in China, we are
particularly focused on our financial situation and are evaluating
all avenues to find a sustainable solution for the Company.”
Key Future Milestones
-
Denali Phase 3 clinical trial evaluating NCX 470 in
patients with open-angle glaucoma or ocular hypertension:
The trial is on track to generate topline results in 2025, based on
current recruitment rates.
-
Initiation of Whistler Phase 3b clinical trial
investigating NCX 470’s dual mechanism of action (nitric oxide and
prostaglandin analog) in intraocular pressure (IOP)
lowering: The Whistler trial is expected to be initiated
in Q4 2023 and to take approximately one year to complete.
-
Approval and launch of ZERVIATE in China by Nicox’s
partner, Ocumension Therapeutics: Expected in 2024.
First Half 2023 Financial Results As of June
30, 2023, the Nicox Group had cash and cash equivalents of €19.0
million as compared with €21.4 million as of March 31, 2023, and
€27.7 million as of December 31, 2022. The Company is currently
funded until the end of June 2024, exclusively on the basis of the
development of NCX 470. The Company is pursuing licensing
discussions which could extend the cash runway. In parallel, the
Company has initiated strategic discussions, including regarding
potential merger and acquisition transactions and is also
initiating discussions with its creditors to restructure its
debt.Net revenue1 for the first half of 2023 was €1.7 million
(consisting entirely of net royalty payments) versus €1.4 million
(including €1.3 million in royalty revenue) for the first half of
2022. Operating expenses for the first half of
2023 were €10.4 million compared to €12.7 million for the first
half of 2022. The decrease in the operating expenses in the first
half of 2023 compared to the first half of 2022 is explained by the
completion of the first Phase 3 trial Mont Blanc in the third
quarter of 2022.The Nicox Group recorded a net loss of €6.6 million
for the six months ended June 30, 2023, compared to a net loss of
€17.0 million for the same period in 2022. The net loss in
the first half of 2022 includes €11.1 million of non-cash items due
to the decision to seek a partner to pursue the development of NCX
4251 in the U.S. As of June 30, 2023, the Nicox Group
had financial debt of €21.6 million, consisting of (i) €18.8
million in the form of a bond financing agreement with Kreos
Capital signed in January 2019, (ii) a €1.6 million credit
agreement guaranteed by the French State, and granted in August
2020 in the context of the COVID-19 pandemic and (iii) €1.2 million
of present value attributed to the put option2 granted in the
November 2022 equity financing. The payment of this latter debt
would only occur if the put option was exercised, subject to the
conditions set out in footnote 2 below. Third
Quarter 2023 Financial Highlights As of September 30,
2023, the Nicox Group had cash and cash equivalents of €14.6
million as compared with €19.0 million as of June 30, 2023, and
€27.7 million as of December 31, 2022. Net revenue for the
third quarter of 2023 was €1.1 million (entirely composed of net
royalty payments). Net revenue for the third quarter of 2022
was €0.8 million (entirely composed of net royalty
payments). As of September 30, 2023, the Nicox Group had
financial debt of €21.1 million, consisting of (i) €18.8 million in
the form of a bond financing agreement with Kreos Capital signed in
January 2019, (ii) a €1.5 million credit agreement guaranteed by
the French State, and granted in August 2020 in the context of the
COVID-19 pandemic and (iii) €0.8 million of present value
attributed to the put option2 granted in the November 2022 equity
financing. The payment of this latter debt would only occur if the
put option was exercised, subject to the conditions set out in
footnote 2 below. VYZULTA® (latanoprostene bunod
ophthalmic solution), 0.024% U.S. prescriptions3 increased by 22%
in the third quarter of 2023 compared to the same period in
2022. VYZULTA, exclusively licensed worldwide to Bausch +
Lomb, is commercialized in more than 15 countries, including the
U.S., and is also approved in a number of other countries.
VYZULTA is indicated for the reduction of IOP in patients with
open-angle glaucoma or ocular hypertension. Only the
figure related to the cash position of the Nicox Group as of
December 31, 2022, is audited; all other figures in this press
release are non-audited. |
About Nicox |
Nicox SA is an international ophthalmology company developing
innovative solutions to help maintain vision and improve ocular
health. Nicox’s lead program in clinical development is NCX 470, a
novel nitric oxide-donating bimatoprost eye drop, for lowering
intraocular pressure in patients with open-angle glaucoma or ocular
hypertension. Nicox generates revenue from VYZULTA® in glaucoma,
licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in
allergic conjunctivitis, licensed in multiple geographies,
including to Harrow, Inc. in the U.S., and Ocumension Therapeutics
in the Chinese and in the majority of Southeast Asian
markets.Nicox, headquartered in Sophia Antipolis, France, is listed
on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the
CAC Healthcare index.For more information on Nicox, its products or
pipeline, please visit: www.nicox.com. |
Analyst coverage |
Bryan, Garnier & Co
Eric
Yoo Paris,
FranceEdison Investment
Research Pooya
Hemami London,
UKH.C. Wainwright &
Co Yi
Chen New York,
U.S. |
|
The views expressed by analysts in their coverage of Nicox are
those of the author and do not reflect the views of Nicox.
Additionally, the information contained in their reports may not be
correct or current. Nicox disavows any obligation to correct or to
update the information contained in analyst reports. |
Contacts |
|
NicoxGavin SpencerExecutive Vice President, Chief
Business Officer& Head of Corporate Development T +33 (0)4 97
24 53 00communications@nicox.com |
|
Forward-Looking Statements |
The information contained in this document may be modified without
prior notice. This information includes forward-looking statements.
Such forward-looking statements are not guarantees of future
performance. These statements are based on current expectations or
beliefs of the management of Nicox S.A. and are subject to a number
of factors and uncertainties that could cause actual results to
differ materially from those described in the forward-looking
statements. Nicox S.A. and its affiliates, directors, officers,
employees, advisers or agents, do not undertake, nor do they have
any obligation, to provide updates or to revise any forward-looking
statements.Risks factors which are likely to have a material effect
on Nicox’s business are presented in section 2.7 of the “Rapport
Annuel 2022” and in section 4 of the “Rapport semestriel financier
et d’activité 2023” which are available on Nicox’s website
(www.nicox.com). |
Nicox S.A.Drakkar 2Bât D, 2405 route des
Dolines06560 Valbonne, FranceT +33 (0)4 97 24 53 00F +33 (0)4 97 24
53 99 |
nicox saInterim
Consolidated statement of Comprehensive Income
|
6 Months period ending June 30, |
|
2023 |
2022 |
|
(in thousands of € except for per share data) |
|
|
|
Revenues from collaborations |
2,772 |
2,322 |
Royalty payments |
(1,039) |
(892) |
Net
Profit from collaborations |
1,733 |
1,430 |
|
|
|
Research and
development expenditures |
(6,690) |
(7,778) |
Administrative
expenses |
(3,511) |
(3,724) |
Other
income |
457 |
371 |
Other
expenses |
(232) |
(1,190) |
Operating loss before amortization of intangible
assets |
(8,243) |
(10,891) |
Amortization
of intangible assets |
- |
- |
Impairment of
intangible assets(1) |
- |
(10,472) |
Operating loss |
(8,243) |
(21,363) |
|
|
|
Finance
income |
3,314 |
3,915 |
Finance expense |
(1,657) |
(1,237) |
Net financial income/(expense) |
1,657 |
2,678 |
|
|
|
Loss before tax |
(6,586) |
(18,685) |
|
|
|
Income tax
(expense) / benefit |
(20) |
1,679 |
|
|
|
Net loss for the period |
(6,606) |
(17,006) |
(1) Non-cash
adjustment on NCX 4251 estimated fair value due to the Group
decision to seek a partner to pursue the development in the
U.S.
nicox saInterim
consolidated statement of financial position
|
As of June 30, 2023 |
As of Dec. 31, 2022 |
|
(in thousands of €) |
ASSETS |
|
|
Non-current assets |
|
|
Goodwill |
26,722 |
27,223 |
Intangible
assets |
31,136 |
31,692 |
Property, plant
and equipment |
414 |
240 |
Non-current
financial assets |
224 |
325 |
Total non-current assets |
58,496 |
59,480 |
Current
assets |
|
|
Clients |
1,911 |
2,639 |
Government grants
receivables |
756 |
504 |
Other current
assets |
1,118 |
1,279 |
Prepayments |
991 |
1,612 |
Cash and cash equivalents |
19,011 |
27,650 |
Total current assets |
23,787 |
33,684 |
TOTAL ASSETS |
82,283 |
93,164 |
EQUITY
AND LIABILITIES |
|
|
Shareholder’s equity |
|
|
Issued
capital |
50,170 |
50,100 |
Share
premium |
538,132 |
538,202 |
Cumulative
translation adjustment |
7,405 |
7,665 |
Treasury
shares |
(989) |
(978) |
Accumulated
deficit |
(549,188) |
(542,556) |
Total Equity |
45,530 |
52,433 |
Non-current liabilities |
|
|
Non-current
financial liabilities |
19,614 |
24,606 |
Deferred tax
liabilities |
7,206 |
7,341 |
Non-current
provisions |
686 |
578 |
Total non-current liabilities |
27,506 |
32,525 |
Current
liabilities |
|
|
Current financial
liabilities |
2,773 |
828 |
Trade
payables |
3,530 |
3,102 |
Deferred
income |
1,792 |
2,183 |
Other current liabilities |
1,152 |
2,093 |
Total current liabilities |
9,247 |
8,206 |
|
|
|
TOTAL LIABILITIES AND EQUITY |
82,283 |
93,164 |
1 Net revenue consists of revenue from
collaborations less royalty payments which corresponds to Net
profit in the consolidated statements of profit or loss.2 In the
case of a merger by acquisition (fusion par absorption), merger
(fusion par création d’une nouvelle société), division (scission),
or a change of control within the meaning assigned in article
L.233-3 I of the French commercial code (Code de commerce) where
the consideration for such transaction is Nicox shares at a value
of less than €1.70, the exercise price of the warrants, Armistice
can request that Nicox purchases the warrants granted to Armistice
at their Black Scholes value (using pre-defined terms). The present
value of this option is revised at each closure and the non-cash
adjustment of the present value is recognized in the consolidated
statement of profit or loss as a finance income or finance
expense. 3 Bloomberg data comparing the period of the
weeks ending July 7 to September 29, 2023 with the period of the
weeks ending July 8 to September 30, 2022.
- EN_2023H1&Q3Results PR _ 20231020_F
Nicox (EU:ALCOX)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Nicox (EU:ALCOX)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024