Nicox Provides Fourth Quarter 2023 Financial and Business Highlights
25 Gennaio 2024 - 7:30AM
UK Regulatory
Nicox Provides Fourth Quarter 2023 Financial and Business
Highlights
Press Release |
Nicox Provides Fourth Quarter 2023 Financial and Business
Highlights |
- NCX 470
Phase 3 Denali clinical trial 75%
randomized
- Net
revenue €1.3 million for fourth quarter 2023 and €4.2 million for
the full year 2023, an increase of
29% compared to the full year
2022
- Cash of
€11.9 million on December 31, 2023
-
The
Company is financed to
June 2024, based on the development of NCX
470 alone, and continues to seek opportunities to increase the cash
runway
January 25, 2024 – release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Growth Paris: FR0013018124,
ALCOX), an international ophthalmology company, today provided
financial and business highlights for the fourth quarter of 2023
for Nicox SA and its subsidiaries (the “Nicox Group”).
“The Denali trial is progressing to plan with 75% of the target
number of patients now randomized. A significant milestone has also
been reached as all patients for the 12-month safety extension have
been enrolled. In parallel, all activities to support the NCX 470
New Drug Application are continuing as planned. The Company remains
focused on the financial situation and finding solutions to extend
the cash runway.” said Andreas Segerros, Chief
Executive Officer of Nicox. “Licensing
revenues, which today come principally from VYZULTA sales, continue
to grow, with annual net royalty payments to Nicox exceeding €4
million for the first time. In 2024 we are expecting approval and
commercialization of ZERVIATE in China, which should further
contribute to licensing revenue growth.”
Fourth Quarter 2023 Financial Highlights
Net revenue1 for the fourth quarter of 2023 was €1.3
million, compared to €1.0 million of net revenue for the fourth
quarter of 2022. Net revenue for the full year 2023 was €4.2
million which is an increase of 29% compared to net revenue for the
full year 2022 of €3.3 million. The net revenues for 2022 and 2023
consisted entirely of net royalty payments.
As of December 31, 2023, the Nicox Group had cash and cash
equivalents of €11.9 million, compared with €14.6 million as of
September 30, 2023 and €27.7 million as of December 31, 2022. The
Company estimates it is financed until June 2024, based exclusively
on the development of NCX 470. The Company is pursuing licensing
and other business development discussions, exploring multiple
strategic options and is also discussing with its creditors to
restructure its debt.
As of December 31, 2023, the Nicox Group had financial debt of
€21.0 million, consisting of (i) €18.9 million in the form of a
bond financing agreement with Kreos Capital signed in January 2019,
(ii) a €1.3 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. prescriptions data were not available for the last
month of 2023, for technical reasons outside of the control of the
Company. 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 intraocular pressure (IOP) in
patients with open-angle glaucoma or ocular hypertension.
Post Fourth Quarter 2023 Events
- 75% of
the number of patients targeted to be included in NCX 470 Denali
Phase 3 clinical trial, which is being conducted in both the U.S.
and China, have been randomized. All patients required for the
12-month safety extension of this trial have now been
enrolled.
Key Future Milestones
-
Approval and launch of ZERVIATE in China by Nicox’s
partner, Ocumension Therapeutics: Expected in early
2024.
-
Whistler Phase 3b clinical trial investigating NCX 470’s
dual mechanism of action (nitric oxide and prostaglandin analog) in
IOP lowering: Results of the Whistler trial initiated in
December 2023 are currently expected in the first quarter of
2025.
-
Denali Phase 3 clinical trial evaluating NCX 470 in
patients with open-angle glaucoma or ocular hypertension:
The Denali trial is on track to generate topline results in 2025,
based on current recruitment rates.
Achievement of milestones relating to NCX 470 are dependent on the
Company increasing its cash runway to cover the completion of those
activities.
Only the December 31, 2022 cash figure 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 www.nicox.com. |
Analyst coverage |
Bryan, Garnier & Co
Eric
Yoo Paris,
France
H.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 |
|
Nicox
Gavin Spencer
Executive Vice President, Chief Business Officer
& Head of Corporate Development
T +33 (0)4 97 24 53 00
communications@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 2
Bât D, 2405 route des Dolines
06560 Valbonne, France
T +33 (0)4 97 24 53 00
F +33 (0)4 97 24 53 99 |
|
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.
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