Nicox Provides Second Quarter 2023 Financial and Business Highlights
19 Luglio 2023 - 7:30AM
Nicox Provides Second Quarter 2023 Financial and Business
Highlights
Press Release |
Nicox Provides Second Quarter 2023 Financial and Business
Highlights |
- Net revenue1 of
€0.9 million for the
second quarter of 2023
- Cash position of
€19.0
million, with a
12-month cash
runway, as of June 30,
2023
- NCX 470 Denali Phase 3 clinical
trial
~55%
randomized
July 19, 2023 – release at 7:30 am CET Sophia Antipolis,
FranceNicox SA (Euronext Paris: FR0013018124,
ALCOX), an international ophthalmology company, today provided
financial and business highlights for the second quarter 2023 for
Nicox SA and its subsidiaries (the “Nicox Group”).“We are pleased
to be able to report the continued progress in recruitment in the
Denali Phase 3 trial, which remains on track for results expected
in 2025, and also to have been able to announce the over $300
million annual global net sales potential for NCX 470, along with
the additional Mont Blanc trial sub-group analysis, showing
superiority over latanoprost in certain patient groups, presented
by leading ophthalmologists at the World Glaucoma Congress a few
weeks ago.” said Andreas Segerros, Chief Executive Officer
of Nicox. “In the last few months, we got the good news
that our Chinese partner, Ocumension Therapeutics, received
Priority Review Status for the ZERVIATE New Drug Application in
China. We look forward to the expected launch of this in 2024,
bringing an additional revenue stream to Nicox. Our development
team remains focused on delivering the Denali trial, and we
continue to review opportunities to expand our pipeline with
additional programs.”Second Quarter
2023 Financial
HighlightsNet revenue1 for the second quarter of 2023 was
€0.9 million (consisting entirely of net royalty payments). This
compares to net revenue for the second quarter of 2022 of €0.7
million (consisting entirely of net royalty payments). 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 estimates it is
financed until June 2024, based exclusively on the development of
NCX 470. The Company is evaluating all possible options to extend
the company’s cash runway, including through business development
and licensing activities and potential additional financing
associated with acquiring new pipeline assets.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.VYZULTA® (latanoprostene
bunod ophthalmic solution), 0.024% U.S. prescriptions3 increased by
26.2% in the second 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 intraocular pressure (IOP) in
patients with open-angle glaucoma or ocular
hypertension.Post Q2
2023 Events
- Around
55% of the number of patients targeted to be included in NCX 470
Denali Phase 3 clinical trial have been randomized.
-
Laboratorios Grin, Nicox’s exclusive partner for ZERVIATE™
(cetirizine ophthalmic solution), 0.24% in Mexico, has provided
notice to Nicox of the termination of this agreement, effective
July 23, 2023. The termination has no financial impact on
Nicox.
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 with topline results expected in 2025. This
date is based on current recruitment rates.
-
Initiation of two new Phase 3b clinical trials
investigating NCX 470’s dual
mechanism of action (nitric oxide and prostaglandin analog) in IOP
lowering and potential benefits on the
retina: The trial, named Whistler,
evaluating NCX 470’s dual mechanism of action in IOP lowering is
expected to be initiated in the next few months. Planning is
continuing for the trial exploring retinal benefits however it is
now expected to start in 2024. Each trial is expected to take
approximately one year to complete.
-
Approval and launch of
ZERVIATE in China by
Ocumension: expected in
2024.
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, for lowering intraocular
pressure in patients with open-angle glaucoma or ocular
hypertension. The company is also conducting research on NCX 1728,
a nitric oxide-donating phosphodiesterase 5 inhibitor, in retinal
conditions. NCX 4251, a novel, patented, ophthalmic suspension of
fluticasone propionate nanocrystals for topical ocular application
for dry eye disease, is being developed by Ocumension Therapeutics
in China under an exclusive license agreement and is available for
partnering elsewhere. Nicox generates revenue from VYZULTA® in
glaucoma, licensed exclusively worldwide to Bausch + Lomb, and
ZERVIATE® in allergic conjunctivitis, licensed in multiple
geographies, including to Eyevance Pharmaceuticals, LLC (a wholly
owned subsidiary of Santen Pharmaceutical Co., Ltd.), 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.Kepler
Cheuvreux Arsene
Guekam Paris,
France |
|
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’ which is 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 |
|
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 April 7, 2023 to June 30,
2023 with the period of the weeks ending April 8, 2022 to July 1,
2022.
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