Oculis Reports Q4 and Full Year 2024 Financial Results and Provides Company Update
-- Successful 2024 marked by significant clinical advancements across
Oculis' late-stage and highly differentiated clinical pipeline targeting
retina (OCS-01 in diabetic macular edema), neuro-ophthalmic (Privosegtor,
OCS-05, in acute optic neuritis) and precision medicine (Licaminlimab,
OCS-02, in dry eye disease) treatments
-- Recent positive topline results in the ACUITY Phase 2 trial showed
Privosegtor (OCS-05)'s neuroprotective benefits in anatomical
preservation of the retina and visual function improvements in acute
optic neuritis
-- Oversubscribed $100 million equity financing completed to support the
advancement of Oculis' late-stage clinical portfolio
-- Upcoming R&D Day planned on April 15, 2025, to showcase pipeline
potential and company strategy
-- Cash, cash equivalents and short-term investments of $109 million as of
December 31, 2024, together with approximately $93 million net proceeds
of recent financing provides cash runway into early 2028
ZUG, Switzerland, March 11, 2025 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) ("Oculis" or the "Company"), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced results for the quarter and full year ended December 31, 2024, and provided an overview of the Company's progress.
Riad Sherif M.D., Chief Executive Officer of Oculis: "We had a momentous year in 2024, and a strong start to 2025. We delivered two positive Phase 2 topline readouts from the ACUITY Privosegtor (OCS-05) trial in acute optic neuritis showing neuroprotective effects and the RELIEF trial of Licaminlimab (OCS-02) in dry eye disease (DED) with a precision medicine approach. In addition, we are on track to complete enrollment in the coming months for both Phase 3 DIAMOND trials of OCS-01 in diabetic macular edema $(DME.AU)$. The recent $100 million equity financing is another significant milestone for Oculis to propel its pipeline. As we continue to execute on our vision to be a leader in ophthalmic and neuro-ophthalmic fields and to bring innovative sight-saving treatments to market, 2025 will be a year in which we remain focused on execution to advance our late-stage clinical portfolio. We look forward to sharing updates on our portfolio strategy at our upcoming R&D Day."
Q4 2024 and Recent Highlights
Clinical Highlights and Upcoming Milestones:
-- OCS-01:
-- On-track to complete enrollment in Phase 3 DIAMOND program in DME
with top-line data readout expected in first half of 2026.
-- NDA submission readiness for post-ocular surgery also on track in
Q1 2025.
-- Privosegtor (OCS-05):
-- Positive topline results from the Phase 2 ACUITY trial in patients
with acute optic neuritis where Privosegtor (OCS-05) achieved
primary endpoint of safety and three secondary efficacy endpoints
demonstrating improvement for Privosegtor (OCS-05) compared to
placebo in objective structural measures of retinal thickness and
functional vision improvement.
-- FDA interactions are planned for the second half of 2025 to
discuss the ACUITY trial results and align on the next steps,
including a registrational development program for acute optic
neuritis.
-- Licaminlimab (OCS-02):
-- Positive readout from the Phase 2b RELIEF trial in signs of DED
and FDA interaction conducted in Q1 2025 confirmed development
path forward with a precision medicine approach.
Further business and pipeline development updates to be provided during the R&D Day on April 15, 2025 in New York City.
Q4 and Full Year 2024 Financial Highlights
-- Cash position: As of December 31, 2024, the Company had total cash, cash
equivalents and short-term investments of CHF 98.7 million or $109.0
million, compared to CHF 91.7 million or $108.9 million as of December
31, 2023. The increase in cash position from December 31, 2023 reflects
the proceeds from the registered direct offering in the second quarter of
2024. Based on its cash, cash equivalents and short-term investments at
December 31, 2024 and approximately $93 million in net proceeds received
from the recent financing, and its development plans, the Company's cash
balances are expected to fund operations into early 2028.
-- Research and development expenses were CHF 11.8 million or $13.4 million
for the three-months ended December 31, 2024, compared to CHF 8.0 million
or $9.0 million in the same period in 2023. Research and development
expenses for the year ended December 31, 2024 were CHF 52.1 million or
$59.1 million, compared to CHF 29.2 million or $32.6 million in the
previous year. The increase was primarily due to clinical development
expenses for the active clinical trials for OCS-01 in DME, Privosegtor
(OCS-05) in acute optic neuritis and Licaminlimab (OCS-02) in DED.
-- General and administrative expenses were CHF 5.5 million or $6.3 million
for the three-months ended December 31, 2024, compared to CHF 4.3 million
or $4.9 million in the same period in 2023. General and administrative
expenses for the year ended December 31, 2024 were CHF 21.8 million or
$24.8 million, compared to CHF 17.5 million or $19.5 million in the
previous year. The increase was primarily due to share-based compensation
expenses.
-- Q4 net loss was CHF 28.7 million or $32.6 million for the fourth quarter
ended December 31, 2024, compared to CHF 12.5 million or $14.1 million
for the same period in 2023. The increase was primarily driven by changes
in the fair value (non-cash) of outstanding warrants, increased clinical
development costs and increased share-based compensation expenses.
-- FY2024 net loss was CHF 85.8 million or $97.4 million for the year ended
December 31, 2024, compared to CHF 88.8 million or $98.8 million for the
same period in 2023. The decrease was primarily due to a non-recurring
and non-cash merger and listing expense recorded in 2023 of CHF 34.9
million or $38.2 million, partially offset by changes in the fair value
of outstanding warrants, increases in clinical development costs and
expenses incurred to operate as a dual-listed public company.
-- FY2024 non-IFRS net loss was CHF 85.8 million or $97.4 million, or CHF
2.12 or $2.41 per share, for the year ended December 31, 2024, compared
to CHF 49.0 million or $54.5 million, or CHF 1.64 or $1.83 per share, for
the same period in 2023. The increase in non-IFRS net loss was primarily
driven by changes in the fair value of outstanding warrants and the
advancement of clinical development programs during the year, including
the Phase 3 DIAMOND-1 and DIAMOND-2 trials for DME, Phase 2 ACUITY trial
for acute optic neuritis, and Phase 2 RELIEF trial for DED.
Non-IFRS Financial Information
This press release contains financial measures that do not comply with International Financial Reporting Standards (IFRS) including non-IFRS loss, and non-IFRS loss attributable to equity holders per common share. These non-IFRS financial measures exclude the impact of items that the Company's management believes affect comparability or underlying business trends. These measures supplement the Company's financial results prepared in accordance with IFRS. The Company's management uses these measures to better analyze its financial results and better estimate its financial outlook. In management's opinion, these non-IFRS measures are useful to investors and other users of the Company's financial statements by providing greater transparency into the ongoing operating performance of the Company and its future outlook. Such measures should not be deemed to be an alternative to IFRS requirements.
The non-IFRS measures for the reported periods reflect adjustments made to exclude:
-- Merger and listing expense, which was a one-time and non-cash expense of
CHF 34.9 million or $38.2 million in the year-to-date 2023 total
operating expenses.
-- During the third quarter of 2023, the Company gave effect to the
dissolution of its Merger Sub 2 entity pursuant to the Business
Combination Agreement with EBAC. As a result, the cumulative translation
adjustments related to Merger Sub 2 previously reported in equity and
recognized in other comprehensive loss, were reclassified from equity to
the Condensed Consolidated Interim Statement of Loss for the year ended
December 31, 2023. The resulting non-cash foreign exchange impact of such
reclassification amounted to CHF 5.0 million or $5.7 million for the year
ended December 31, 2023.
Consolidated Statements of Financial Position
(Amounts in CHF thousands) As of December 31, As of December 31,
------------------ ------------------
2024 2023
------------------ ------------------
ASSETS
Non-current assets
Property and equipment, net 385 288
Intangible assets 13,292 12,206
Right-of-use assets 1,303 755
Other non-current assets 476 89
Total non-current assets 15,456 13,338
------------------ ------------------
Current assets
Other current assets 5,605 8,488
Accrued income 629 876
Short-term financial assets 70,955 53,324
Cash and cash equivalents 27,708 38,327
Total current assets 104,897 101,015
------------------ ------------------
TOTAL ASSETS 120,353 114,353
================== ==================
EQUITY AND LIABILITIES
Shareholders' equity
Share capital 446 366
Share premium 344,946 288,162
Reserve for share-based
payment 16,062 6,379
Actuarial loss on
post-employment benefit
obligations (2,233) (1,072)
Treasury shares (10) -
Cumulative translation
adjustments (271) (327)
Accumulated losses (285,557) (199,780)
Total equity 73,383 93,728
------------------ ------------------
Non-current liabilities
Long-term lease liabilities 865 431
Long-term payables - 378
Defined benefit pension
liabilities 1,870 728
Total non-current liabilities 2,735 1,537
------------------ ------------------
Current liabilities
Trade payables 5,871 7,596
Accrued expenses and other
payables 18,198 5,948
Short-term lease liabilities 315 174
Warrant liabilities 19,851 5,370
Total current liabilities 44,235 19,088
------------------ ------------------
Total liabilities 46,970 20,625
------------------ ------------------
TOTAL EQUITY AND LIABILITIES 120,353 114,353
================== ==================
Consolidated Statements of Loss
(Amounts in CHF
thousands,
except per share For the three months ended For the years ended
data) December 31, December 31,
-------------------------- ---------------------
2024 2023 2024 2023
------------ ------------ ---------- ---------
Grant income 3 185 686 883
Operating income 3 185 686 883
------------ ------------ ---------- ---------
Research and
development
expenses (11,763) (8,029) (52,083) (29,247)
General and
administrative
expenses (5,500) (4,340) (21,807) (17,487)
Merger and
listing expense - - - (34,863)
Operating
expenses (17,263) (12,369) (73,890) (81,597)
------------ ------------ ---------- ---------
Operating loss (17,260) (12,184) (73,204) (80,714)
------------ ------------ ---------- ---------
Finance income 371 656 2,168 1,429
Finance expense (247) (12) (639) (1,315)
Fair value
adjustment on
warrant
liabilities (13,387) 1,207 (15,531) (3,431)
Foreign currency
exchange loss,
net 1,630 (2,179) 1,269 (4,664)
Finance result,
net (11,633) (328) (12,733) (7,981)
------------ ------------ ---------- ---------
Loss before tax
for the period (28,893) (12,512) (85,937) (88,695)
------------ ------------ ---------- ---------
Income tax
expense 238 13 160 (107)
Loss for the
period (28,655) (12,499) (85,777) (88,802)
============ ============ ========== =========
Loss per share:
Basic and diluted
loss
attributable to
equity holders (0.67) (0.34) (2.12) (2.97)
Reconciliation of Non-IFRS
Measures (Unaudited)
(Amounts in CHF thousands,
except per share data)
For the years ended December 31,
------------------------------------
2024 2023
---------------- ----------------
IFRS loss for the period (85,777) (88,802)
Non-IFRS adjustments:
Merger and listing
expense (i) - 34,863
Merger Sub 2
reclassification from
equity to foreign
exchange loss (ii) - 4,978
Non-IFRS loss for the period (85,777) (48,961)
---------------------------- ---------------- ----------------
IFRS basic and diluted loss
attributable to equity
holders (2.12) (2.97)
Non-IFRS basic and diluted
loss attributable to equity
holders (2.12) (1.64)
---------------------------- ---------------- ----------------
IFRS weighted-average number
of shares used to compute
loss per share basic and
diluted 40,406,551 29,899,651
---------------------------- ---------------- ----------------
(i) Merger and listing expense is the difference between
the fair value of the shares transferred and the fair
value of the EBAC net assets per the Business Combination
Agreement. This merger and listing expense is non-recurring
in nature and represented a share-based payment made
in exchange for a listing service and does not lead
to any cash outflows.
(ii) The reclassification of cumulative translation
adjustments from equity to foreign exchange loss results
from the impact of the dissolution of Merger Sub 2.
This exchange loss is non-recurring in nature and
does not lead to any cash outflows.
About Oculis
Oculis is a global biopharmaceutical company (Nasdaq: OCS / XICE: OCS) purposefully driven to save sight and improve eye care. Oculis' highly differentiated pipeline of multiple innovative product candidates in clinical development includes: OCS-01, a topical eye drop candidate for diabetic macular edema (DME); Privosegtor (OCS-05), a neuroprotective candidate for acute optic neuritis with potentially broad clinical applications in other neuro-ophthalmic diseases; and Licaminlimab (OCS-02), a topical biologic anti-TNF<ALPHA> eye drop candidate for dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and is supported by leading international healthcare investors.
For more information, please visit: www.oculis.com
Oculis Contacts
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com
Investor & Media Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company's product candidates, the timing, progress and results of current and future clinical trials, including the Company's Phase 3 DIAMOND program in DME, Oculis' research and development programs, regulatory and business strategy, future development plans; the timing or likelihood of regulatory filings and approvals; and the Company's expected cash runway are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis' control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis' annual report on Form 20-F and other documents filed with the U.S. Securities and Exchange Commission (the "SEC"). Copies of these documents are available on the SEC's website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
(END) Dow Jones Newswires
March 11, 2025 16:30 ET (20:30 GMT)