- Nicox Group revenue of €4.4
million (net revenue1 €3.9
million) for first quarter 2024
- Nicox Group cash of €9.1
million on March 31, 2024 which finances the Company until at least
November 2024
April 22, 2024 – release at 7:30 am CETSophia Antipolis,
FranceNicox SA (Euronext Growth Paris:
FR0013018124, ALCOX), an international ophthalmology company, today
provided the revenue and cash position for Nicox SA and its
subsidiaries (the “Nicox Group”) for the first quarter of 2024 and
financial results for Nicox SA (the “Company) for the full year of
2023, as approved by the Board of Directors on April 19, 2024, and
provided an update on key future milestones. As previously
announced, the Company is no longer reporting consolidated accounts
under IFRS standards and figures communicated for the Nicox Group
are for information only. The Company also announced that its CEO,
Gavin Spencer, has joined the Board of Directors.“Nicox made good
progress in 2023 as we move towards topline results of the Denali
Phase 3 trial which we expect in H2 2025. We implemented the cost
reduction previously communicated in order to focus on the Denali
trial. We also entered into a new licensing agreement for NCX 470
with Kowa for Japan and completed the signature of our debt
restructuring amendment with BlackRock,” said Gavin
Spencer, Chief Executive Officer of Nicox. “We are fully
focused on development of NCX 470 and the Denali trial, which
should confirm the profile of NCX 470 in glaucoma and open up
further strategic options and routes to commercialization, beyond
our existing partnerships. Our cash runway has been extended to
November 2024 and we continue to consider all options for further
financing, including a number of business development discussions
which could provide non-dilutive capital, in parallel with planning
to raise funds from equity capital markets.” “We are very pleased
to welcome Gavin Spencer, our new CEO, as a member of the Nicox
Board of Directors. Gavin will provide valuable expertise as a
member of the Board, based on his wide-ranging experience across
all aspects of the biopharma industry and deep knowledge of the
Nicox business,” said Jean-François Labbé, Chairman of
Nicox.Revenue, Cash Position for the Nicox Group
for the First Quarter 2024
- Nicox
Group revenue of €4.4 million (net revenue1 €3.9 million, including
a €3.0 million license payment) for the first quarter of 2024
compared to €1.3 million (net revenue1 €0.8 million, entirely
composed of net royalties) for the first quarter 2023;
- Cash of
€9.1 million at 31 March 2024 compared to €11.9 million at 31
December 2023;
- As of
March 31, 2024, the Nicox Group had financial debt of €20.6 million
(entirely held by Nicox SA), consisting of €19.4 million in the
form of a bond financing agreement with Kreos Capital (an affiliate
of BlackRock), and a €1.2 million credit agreement guaranteed by
the French State, and granted in the context of the COVID-19
pandemic.
As part of the restructuring of the Company’s debt announced on 28
February 2024, the Company is required to raise at least €3 million
in equity financing by 30 September 2024 in order to extend its
interest-only period, which would increase the cash runway into Q1
2025. The second call of an Extraordinary General Meeting is being
held on May 6 to approve the resolutions for this financing.The
Company is pursuing business development discussions, including the
sale or license of certain assets, and exploring multiple other
strategic options which could further extend the cash runway. The
Company is evaluating all options for financing and will use the
most appropriate at the time.Post First Quarter 2024
Events
- The
Nicox Board of Directors has co-opted Dr Gavin Spencer, CEO of
Nicox, as a Board member with effect from April 8, 2024. This
co-optation will be put to a vote at the General Meeting for the
approval of the 2023 accounts.
- The
World Health Organisation (“WHO”) has recommended the International
Nonproprietary Name (“INN”) bimatoprost grenod for NCX 470.
- The U.S.
patent 8,058,467 for VYZULTA® (latanoprostene bunod ophthalmic
solution), 0.024%, has been extended to 2029 under the Drug Price
Competition and Patent Term Restoration Act of 1984 (also known as
the “Hatch-Waxman Act”). 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.
- The debt
restructuring amendment which was agreed in principle between Nicox
and BlackRock and announced on February 28, 2024 was signed.
- Posters
originally planned to be presented at the upcoming Association for
Research in Vision and Ophthalmology (ARVO) Annual Meeting 2024
will not be presented for organisational reasons.
Key Future Milestones
-
Approval and launch of ZERVIATE in China by Nicox’s
partner, Ocumension Therapeutics: Expected in 2024.
-
Whistler Phase 3b clinical trial, initiated in December
2023, investigating bimatoprost grenod (NCX 470)’s dual mechanism
of action (nitric oxide and prostaglandin analog) in IOP
lowering: Results are currently expected in the first
quarter of 2025.
-
Denali Phase 3 clinical trial evaluating bimatoprost grenod
(NCX 470) in patients with open-angle glaucoma or ocular
hypertension: The Denali trial is over 80% randomized and
expected to generate topline results in H2 2025, based on current
recruitment rates.
Achievement of milestones relating to NCX 470 is dependent on the
Company increasing its cash runway to cover the completion of those
activities. Revenue and Cash Position for the Nicox Group
for 2023
- Nicox
Group revenue of €6.7 million (net revenue1 €4.2 million) at 31
December 2023 compared to €5.2 million (net revenue1 €3.3 million)
for the same period in 2022, both entirely composed of net
royalties.
- Cash of
€11.9 million at 31 December 2023 compared to €27.7 million at 31
December 2022.
Full Year 2023 Financial Results For Nicox
SA Revenue for the full year of 2023 was €6.9
million, consisting of royalty payments and internal rebilling
versus €5.5 million (same sources) for the full year of
2022. Operating expenses for the full year of 2023
were €24.2 million compared to €24.8 million for the full year of
2022. Nicox SA recorded a net loss of €20.9 million for the twelve
months ended December 31, 2023, compared to a net loss of €31.3
million for the same period in 2022. The difference is due to
the variation of the provision for depreciation of shares in the
American affiliate in 2022.As of December 31, 2023, Nicox SA had
cash and cash equivalents of €11.3 million compared to €27.1
million as of December 31, 2022. The Company is currently funded
until at least the end of November 2024, based on focusing
exclusively on the development of NCX 470. As of December 31, 2023,
Nicox SA had financial debt of €20.9 million, consisting of €19.6
million in the form of a bond financing agreement with Kreos
Capital (an affiliate of BlackRock), including €0.1 million of
interest due, and a €1.3 million credit agreement guaranteed by the
French State, and granted in the context of the COVID-19 pandemic.
The audit procedures on the 2023 statutory financial
statements of Nicox SA have been completed and the certification
report is in the process of being issued. All other figures in this
press release are non-audited. |
|
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 bimatoprost
grenod (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. |
|
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).Finally, this press release may be drafted in the
French and English languages. If both versions are interpreted
differently, the French language version shall prevail. |