Page | |
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS: | |
F-2 | |
F-3 | |
F-4 - F-5 | |
F-6 | |
F-7 - F-14 |
December 31,
|
June 30,
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|||||||
2024
|
2025
|
|||||||
Assets
|
||||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Bank deposits
|
|
|
||||||
Marketable securities
|
|
|
||||||
Accounts receivables
|
|
|
||||||
Prepaid expenses and other current assets
|
|
|
||||||
TOTAL CURRENT ASSETS
|
|
|
||||||
NON-CURRENT ASSETS:
|
||||||||
Restricted long-term deposits and cash equivalents
|
|
|
||||||
Long-term receivables
|
|
|
||||||
Property and equipment, net
|
|
|
||||||
Operating lease right-of-use assets
|
|
|
||||||
Other long-term assets
|
|
|
||||||
Funds in respect of employee rights upon retirement
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|
|
||||||
TOTAL NON-CURRENT ASSETS
|
|
|
||||||
TOTAL ASSETS
|
$
|
|
$
|
|
||||
Liabilities and shareholders' equity
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Accounts payable
|
$
|
|
$
|
|
||||
Other accounts payable
|
|
|
||||||
Current maturities of operating leases
|
|
|
||||||
TOTAL CURRENT LIABILITIES
|
|
|
||||||
LONG-TERM LIABILITIES:
|
||||||||
Operating leases liabilities
|
|
|
||||||
Liability for employee rights upon retirement
|
|
|
||||||
Other long-term Liability
|
|
|
||||||
TOTAL LONG-TERM LIABILITIES
|
|
|
||||||
TOTAL LIABILITIES
|
|
|
||||||
SHAREHOLDERS' EQUITY:
|
||||||||
Ordinary shares, NIS
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
TOTAL SHAREHOLDERS' EQUITY
|
|
|
||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
|
$
|
|
$
|
|
Six months ended
June 30
|
Three months ended
June 30
|
|||||||||||||||
2024
|
2025
|
2024
|
2025
|
|||||||||||||
REVENUE
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
RESEARCH AND DEVELOPMENT EXPENSES
|
|
|
|
|
||||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
|
|
|
|
||||||||||||
OPERATING INCOME (LOSS)
|
$
|
(
|
)
|
|
$
|
|
$
|
|
||||||||
FINANCIAL INCOME, net
|
|
|
|
|
||||||||||||
NET INCOME (LOSS) FOR THE PERIOD
|
$
|
(
|
)
|
|
$
|
|
$
|
|
||||||||
BASIC AND DILUTED EARNINGS (LOSS) PER ORDINARY SHARE
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
|
|||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED EARNINGS (LOSS) PER SHARE *
|
|
|
|
|
Ordinary shares
|
Additional
paid-in capital
|
Accumulated
deficit
|
Total
|
|||||||||||||||||
Number of
shares *
|
Amounts
|
Amounts
|
||||||||||||||||||
BALANCE AS OF JANUARY 1, 2024
|
|
|
|
(
|
)
|
|
||||||||||||||
CHANGES DURING THE SIX MONTHS ENDED JUNE 30, 2024:
|
||||||||||||||||||||
Loss for the period
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||
Share-based compensation
|
|
|
|
|
||||||||||||||||
BALANCE AT JUNE 30, 2024
|
|
|
|
(
|
)
|
|
||||||||||||||
BALANCE AS OF JANUARY 1, 2025
|
|
|
|
(
|
)
|
|
||||||||||||||
CHANGES DURING THE SIX MONTHS ENDED JUNE 30, 2025:
|
||||||||||||||||||||
Income for the period
|
|
|
|
|
|
|||||||||||||||
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
BALANCE AT JUNE 30, 2025
|
|
|
|
(
|
)
|
|
Ordinary shares
|
Additional
paid-in capital
|
Accumulated
deficit
|
Total
|
|||||||||||||||||
Number of
shares *
|
Amounts
|
Amounts
|
||||||||||||||||||
BALANCE AS OF APRIL 1, 2024
|
|
|
|
(
|
)
|
|
||||||||||||||
CHANGES DURING THE THREE MONTHS ENDED JUNE 30, 2024:
|
||||||||||||||||||||
Income for the period
|
|
|
|
|
||||||||||||||||
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
BALANCE AT JUNE 30, 2024
|
|
|
|
(
|
)
|
|
||||||||||||||
BALANCE AS OF APRIL 1, 2025
|
|
|
|
(
|
)
|
|
||||||||||||||
CHANGES DURING THE THREE MONTHS ENDED JUNE 30, 2025:
|
||||||||||||||||||||
Income for the period
|
|
|
|
|
|
|||||||||||||||
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
BALANCE AT JUNE 30, 2025
|
|
|
|
(
|
)
|
|
Six months ended
June 30
|
||||||||
2024
|
2025
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Imcome (loss) for the period
|
$
|
(
|
)
|
$
|
|
|||
Adjustments required to reconcile loss to net cash used in operating activities:
|
||||||||
Depreciation
|
|
|
||||||
Changes in accrued liability for employee rights upon retirement, net
|
(
|
)
|
(
|
)
|
||||
Share-based compensation expenses
|
|
|
||||||
Financial expenses (income), net
|
(
|
)
|
|
|||||
Net changes in operating leases
|
(
|
)
|
|
|||||
Changes in fair value of marketable securities
|
(
|
)
|
|
|||||
Changes in operating asset and liabilities:
|
||||||||
Accounts receivables
|
(
|
)
|
(
|
)
|
||||
Prepaid expenses and other current assets
|
|
|
||||||
Accounts payable, accrued expenses and other
|
|
|
||||||
Net cash provided by (used in) operating activities
|
(
|
)
|
|
|||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchase of property and equipment
|
|
(
|
)
|
|||||
Proceeds from sale of property and equipment
|
|
|
||||||
Investment in marketable securities
|
|
(
|
)
|
|||||
Proceeds from maturity of marketable securities
|
|
|
||||||
Short-term deposits
|
|
|
||||||
Long-term deposits
|
|
(
|
)
|
|||||
Net cash provided by (used in) investing activities
|
|
(
|
)
|
|||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
||||||
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS
|
|
(
|
)
|
|||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AND CASH EQUIVALENTS
|
|
(
|
)
|
|||||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD
|
|
|
||||||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AND CASH EQUIVALENTS AT END OF THE PERIOD
|
$
|
|
$
|
|
||||
Cash and Cash equivalents
|
|
|
||||||
Restricted cash equivalents included in restricted long-term deposits and cash equivalents
|
|
|
||||||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH SHOWN IN STATEMENT OF CASH FLOWS
|
|
|
||||||
SUPPLEMENTARY INFORMATION:
|
||||||||
Interest received
|
$
|
|
$
|
|
a. |
$
|
b. |
$
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands)
(Unaudited)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands)
(Unaudited)
a. |
Basis of Presentation
The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial statements. Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of June 30, 2025, the consolidated results of operations and the statements of changes in shareholders' equity for the six and three month periods ended June 30, 2025 and 2024 and the statements of cash flows for the six month periods ended June 30, 2025 and 2024.
|
b. |
Earnings (Loss) per share
|
Basic earnings (loss) per share is computed on the basis of the net earnings (loss) for the period divided by the weighted average number of ordinary shares outstanding during the period. Diluted earnings (loss) per share is based upon the weighted average number of ordinary shares and of potential ordinary shares outstanding when dilutive. Potential ordinary shares include outstanding stock options and warrants, which are included under the treasury stock method when dilutive.
|
c. |
Newly issued accounting pronouncements, not yet adopted:
|
1) |
In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily though changes to disclosure regarding rate reconciliation and income taxes paid. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands)
(Unaudited)
2) |
In November 2024, the FASB issued ASU 2024-03 “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses”, which requires disclosure about the types of costs and expenses included in certain expense captions presented on the income statement as well as disclosures about selling expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted, and may be applied either prospectively or retrospectively. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
|
December 31,
|
June 30,
|
|||||||
2024
|
2025
|
|||||||
Level 2 securities:
|
||||||||
Corporate bonds*
|
$
|
|
$
|
|
||||
U.S government
|
$
|
|
||||||
Total
|
$
|
|
$
|
|
Marketable securities
|
||||||||
For the year ended
|
For the Six Months
|
|||||||
December 31, 2024
|
ended June 30, 2025
|
|||||||
Balance at beginning of the period
|
$
|
|
$
|
|
||||
Purchases
|
|
|
||||||
Maturity
|
(
|
)
|
(
|
)
|
||||
Changes in fair value during the period
|
(
|
)
|
(
|
)
|
||||
Balance at end of the period
|
$
|
|
$
|
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands)
(Unaudited)
Six months ended
June 30
|
Three months ended
June 30
|
|||||||||||||||
2024
|
2025
|
2024
|
2025
|
|||||||||||||
Royalties revenue
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Sale of IP
|
|
|
|
|
||||||||||||
License revenue
|
- |
|
- |
|
||||||||||||
Support services
|
|
|
|
|
||||||||||||
Total revenue
|
$
|
|
$
|
|
$
|
|
$
|
|
Six months ended
June 30
|
Three months ended
June 30
|
|||||||||||||||
2024
|
2025
|
2024
|
2025
|
|||||||||||||
Payroll and related expenses
|
$
|
|
|
$
|
|
$
|
|
|||||||||
Clinical and preclinical trials expenses
|
|
|
|
|
||||||||||||
Professional consulting and subcontracted work
|
|
|
|
|
||||||||||||
Supplier-led manufacturing development
|
|
|
|
|
||||||||||||
Other
|
|
|
|
|
||||||||||||
Total Research and development expenses
|
$
|
|
$
|
|
$
|
|
$
|
|
a. |
In June 2021, the Company entered into two exclusive license agreements with Galderma for the commercialization of two of the Company's most advanced investigational drug products (Twyneo® and Epsolay®) in the United States. During the six months ended June 30, 2025 and 2024 the Company recognized $
|
b. |
On June 6, 2023, the Company and Searchlight Pharma Inc. (“Searchlight”), a private Canadian specialty pharmaceutical company, signed on an exclusive license agreements for Twyneo® and Epsolay® for the Canadian market,
Under the agreement, the Company will receive up to $
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands)
(Unaudited)
c. |
In August 15, 2024, the Company entered into a Termination Agreement ("the Agreement") with the Padagis Israel Pharmaceuticals Ltd (“Padagis”). The purpose of the Agreement is to terminate the Development, Manufacturing and Commercialization Agreement dated June 28, 2020, and to sell its rights to Padagis in relation to Roflumilast cream and Roflumilast foam. As consideration for the Agreement between the parties, Padagis will pay to the Company $
The Company has identified one performance obligation in the agreement. Revenue from sale of IP is recognized at a point in time, upon transfer of control over the sale of the IP to Padagis. Royalties from sale of IP are included in the transaction price based on expected value method but included in the transaction price only when it is probable that a significant reversal of cumulative revenues will not occur. For the year ended December 31, 2024, the Company recognized revenue for a total amount of $
|
d. |
On May 15, 2024, the Company and Beimei, a private Chinese company, signed an agreement for purchase by Beimei of certain rights in the intellectual property ("IP") related to Twyneo, for the treatment of acne vulgaris, in the mainland of China, Hong Kong, Macau, Taiwan and Israel. Under the terms of the agreement, Beimei will purchase from the Company the IP in these territories. The Company is also required to support Beimei to a certain extent during the period until obtaining regulatory approval. The Company may provide further support services to Beimei, if needed, based on agreed upon rates. In return, Sol-Gel is to receive payments of up to $
The Company has identified multiple performance obligations in the agreement. Revenue from sale of IP is recognized at a point in time, upon transfer of control over the IP to Beimei. Support services are recognized over time as the services are performed.
In July and November 2024, the Company received $
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands)
(Unaudited)
For the six months ended June 30, 2025, the Company did not recognize any revenue from the sale of intellectual property (IP), compared to $
In addition, the Company allocated $
|
e. |
On April 17, 2025, the Company entered into a product purchase agreement with a subsidiary of Mayne Pharma Group Limited (“Mayne Pharma”) for the sale and exclusive license of the U.S. rights to EPSOLAY and TWYNEO. Under the terms of the agreement, the Company is entitled to receive a total of $
|
a. |
Ordinary shares |
b. |
Options grants
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands)
(Unaudited)
2025
|
|
Value of one ordinary share
|
$
|
Dividend yield
|
|
Expected volatility
|
|
Risk-free interest rate
|
|
Expected term
|
|
a. |
Related parties include the controlling shareholder and companies under his control, the board of directors and the executive officers of the Company.
|
b. |
As to options granted to executive officers, see note 6.
|
c. |
As of January 1, 2025, Mr. Mori Arkin, the Company’s Executive Chairman and controlling shareholder serves as the interim CEO of the Company. Mr. Arkin will not be entitled to any compensation for assuming this position.
|