ZUG, Switzerland, and BOSTON, Aug. 29, 2023 (GLOBE NEWSWIRE) — Oculis Holding AG (Nasdaq: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced second quarter and first half 2023 financial results for the period ended June 30, 2023, and an overview of the Company’s progress.
Riad Sherif MD, Chief Executive Officer of Oculis: “This has been a very exciting period for Oculis. Following our successful listing on NASDAQ, we had two OCS-01 positive Phase 3 readouts with robust statistically significant results in two different indications, further validating the potential of OCS-01 to treat both back and front of the eye conditions. We are optimistic about our portfolio and remain on track for multiple readouts in 2024. We look forward to building upon the positive momentum we’ve achieved thus far in 2023 as we continue to execute on our strategic goals.”
First Half 2023 and Recent Corporate Developments
Clinical Developments
OCS-01: a novel high concentration preservative-free topical OPTIREACH® formulation of dexamethasone with the potential to treat both front and back of the eye indications:
Key Operational Updates
Awards and Company Recognition
Upcoming Milestones
In the second half of 2023 the Company is focused on advancing its innovative pipeline and planned clinical development programs including:
Financial Highlights
Non-IFRS Financial Information
This press release contains financial measures that do not comply with International Financial Reporting Standards (IFRS) including non-IFRS loss for the period, 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 CHF 34.9 million or $38.2 million in the first quarter of 2023 and in the year-to-date total operating expenses. The non-IFRS measures presented here are also unlikely to be comparable with non-IFRS disclosures released by other companies. See the “Reconciliation of Non-IFRS Measures (Unaudited)” table below for a reconciliation of these non-IFRS measures to the most directly comparable IFRS measures.
Condensed Consolidated Balance Sheets (Unaudited)
(Amounts in CHF thousands)
As of June 30, | As of December 31, | ||||
2023 | 2022 | ||||
ASSETS | |||||
Non-current assets | |||||
Property and equipment, net | 321 | 365 | |||
Intangible assets | 12,206 | 12,206 | |||
Right-of-use assets | 835 | 758 | |||
Other non-current assets | 113 | 74 | |||
Total non-current assets | 13,475 | 13,403 | |||
Current assets | |||||
Other current assets | 6,063 | 2,959 | |||
Accrued income | 1,296 | 912 | |||
Short-term financial assets | 72,078 | – | |||
Cash and cash equivalents | 41,932 | 19,786 | |||
Total current assets | 121,369 | 23,657 | |||
TOTAL ASSETS | 134,844 | 37,060 | |||
EQUITY AND LIABILITIES | |||||
Shareholders’ equity | |||||
Share capital | 364 | 39 | |||
Share premium | 286,696 | 10,742 | |||
Reserve for share-based payment | 4,136 | 2,771 | |||
Actuarial loss on post-employment benefit obligations | (539 | ) | (264 | ) | |
Treasury shares | – | (1 | ) | ||
Cumulative translation adjustments | (3,591 | ) | (300 | ) | |
Accumulated losses | (169,870 | ) | (110,978 | ) | |
Total equity | 117,196 | (97,991 | ) | ||
Non-current liabilities | |||||
Long-term lease liabilities | 539 | 491 | |||
Long-term financial debt | – | 122,449 | |||
Defined benefit pension liabilities | 305 | 91 | |||
Total non-current liabilities | 844 | 123,031 | |||
Current liabilities | |||||
Trade payables | 3,920 | 3,867 | |||
Accrued expenses and other payables | 8,407 | 8,011 | |||
Short-term lease liabilities | 177 | 142 | |||
Warrant liabilities | 4,300 | – | |||
Total current liabilities | 16,804 | 12,020 | |||
Total liabilities | 17,648 | 135,051 | |||
TOTAL EQUITY AND LIABILITIES | 134,844 | 37,060 | |||
Condensed Consolidated Statements of Operations (Unaudited)
(Amounts in CHF thousands, except per share data)
For the three months ended June 30, |
For the six months ended June 30, |
||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
Grant income | 250 | 240 | 479 | 496 | |||||||
Operating income | 250 | 240 | 479 | 496 | |||||||
Research and development expenses | (6,198 | ) | (6,702 | ) | (12,346 | ) | (10,743 | ) | |||
General and administrative expenses | (4,797 | ) | (2,776 | ) | (8,840 | ) | (4,143 | ) | |||
Merger and listing expense | – | – | (34,863 | ) | – | ||||||
Operating expenses | (10,995 | ) | (9,478 | ) | (56,049 | ) | (14,886 | ) | |||
Operating loss | (10,745 | ) | (9,238 | ) | (55,570 | ) | (14,390 | ) | |||
Finance income | 216 | 7 | 253 | 8 | |||||||
Finance expense | (17 | ) | (1,665 | ) | (1,297 | ) | (3,285 | ) | |||
Fair value adjustment on warrant liabilities | (2,625 | ) | – | (2,203 | ) | – | |||||
Foreign currency exchange gain (loss), net | 408 | (1,406 | ) | 161 | (1,832 | ) | |||||
Finance result, net | (2,018 | ) | (3,064 | ) | (3,086 | ) | (5,109 | ) | |||
Loss before tax for the period | (12,763 | ) | (12,302 | ) | (58,656 | ) | (19,499 | ) | |||
Income tax expense | (114 | ) | (42 | ) | (236 | ) | (64 | ) | |||
Loss for the period | (12,877 | ) | (12,344 | ) | (58,892 | ) | (19,563 | ) | |||
Loss per share: | |||||||||||
Basic and diluted loss attributable to equity holders | (0.38 | ) | (3.64 | ) | (2.53 | ) | (5.84 | ) | |||
Reconciliation of Non-IFRS Measures (Unaudited)
(Amounts in CHF thousands, except per share data)
For the three months ended June 30, |
For the six months ended June 30, |
||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
IFRS loss for the period | (12,877 | ) | (12,344 | ) | (58,892 | ) | (19,563 | ) | |||
Non-IFRS adjustments: | |||||||||||
Merger and listing expense (i) | – | – | 34,863 | – | |||||||
Non-IFRS loss for the period | (12,877 | ) | (12,344 | ) | (24,029 | ) | (19,563 | ) | |||
IFRS basic and diluted loss attributable to equity holders | (0.38 | ) | (3.64 | ) | (2.53 | ) | (5.84 | ) | |||
Non-IFRS basic and diluted loss attributable to equity holders | (0.38 | ) | (3.64 | ) | (1.03 | ) | (5.84 | ) | |||
IFRS weighted-average number of shares used to compute loss per share basic and diluted | 33,565,542 | 3,392,346 | 23,274,136 | 3,350,458 | |||||||
(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. |
About Oculis
Oculis (Nasdaq: OCS) is a global biopharmaceutical company purposefully driven to save sight and improve eye care. Oculis’s highly differentiated clinical-stage pipeline comprises multiple innovative product candidates in development for eye diseases of high unmet need. It includes OCS-01 eye drops, a topical candidate in Phase 3 development for diabetic macular edema (DME) and inflammation and pain following ocular surgery; OCS-02 eye drops, a topical biologic candidate in Phase 2 development for dry eye disease (DED) and uveitis; and OCS-05, a disease modifying candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders, such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. The first in-patient, proof-of-concept trial with OCS-05 is currently ongoing in France. Headquartered in Switzerland and with operations in the US, Oculis’ goal is to deliver life-changing eye treatments to patients worldwide. The company is led by an experienced management team with a successful track record in the pharmaceutical industry, supported by leading international healthcare investors.
For more information, please visit: www.oculis.com
Oculis Contacts
Mrs. Sylvia Cheung, CFO
sylvia.cheung@oculis.com
Investor & Media Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
1-212-915-2577
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of OCS-01, including patient impact and market opportunity; the potential of OCS-01 for treating front- and back-of-the-eye diseases; the potential for OCS-01 to become a new standard of care with the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery; the potential of OCS-01 for the treatment of DME, inflammation and pain following ocular surgery and CME; expected cash runway; expected future milestones and catalysts; the initiation, timing, progress and results of Oculis’ clinical and preclinical studies; Oculis’ research and development programs, regulatory and business strategy, future development plans, and management; Oculis’ ability to advance product candidates into, and successfully complete, clinical trials; and the timing or likelihood of regulatory filings and approvals, 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 any 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.
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