Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2023 |
Significant Accounting Policies [Abstract] | |
Basis of presentation of the financial statements: | a. Basis of presentation of the financial statements: The Company’s consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (U.S. GAAP). |
Use of estimates | b. Use of estimates: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the consolidated financial statements, and the reported amount of expenses during the reporting periods. Actual results could differ from those estimates. |
Principles of consolidation | c. Principles of consolidation: The consolidated financial statements include the accounts of the Company and its subsidiary. Intercompany balances have been eliminated upon consolidation. The Company has one operating segment and reporting unit. |
Consolidated financial statements in U.S dollars | d. Consolidated financial statements in U.S dollars: The functional currency is the currency that best reflects the economic environment in which the Company and its subsidiary operates and conducts their transactions. Most of the Company’s revenues and costs are incurred in U.S. dollar. In addition, the Company’s financing activities are incurred in U.S. dollars. The Company’s management believes that the functional currency of the Company is the U.S. dollar. Accordingly, monetary accounts maintained in currencies other than the U.S. dollar are remeasured into U.S. dollars in accordance with ASC No. 830 “Foreign Currency Matters.” All transaction gains and losses of the remeasured monetary balance sheet items are reflected in the statements of operations as financing income or expenses as appropriate. |
Cash and cash equivalents | e. Cash and cash equivalents: Cash equivalents are short-term highly liquid deposits that are readily convertible to cash with original maturities of three months or less, at the date acquired. |
Short-term and long-term restricted deposits | f. Short-term and long-term restricted deposits: Restricted short-term deposits are deposits with maturities of up to one year and are used as security for the rental of premises and as guarantee for the Israeli Investment Center. Restricted long-term deposits are deposits with maturities of more than one year and are used as security for the rental of premises and for the Company’s credit cards. |
Property, plant and equipment | g. Property, plant and equipment: Property, plant and equipment are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment losses and any related investment grants, excluding day-to-day servicing expenses. Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Machinery 10-15 Leasehold improvements (*) Office, furniture and equipment 6-33 Production plant 11 (*) Over the shorter of the term of the lease or its useful life. |
Impairment of long-lived assets: | h. Impairment of long-lived assets: The Company’s long-lived assets are reviewed for impairment in accordance with ASC No. 360 “Property, Plant and Equipment,” whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If indicators of impairment exist and the undiscounted future cash flows that the assets are expected to generate are less than the carrying value of the assets, the Company reduces the carrying amount of the assets through an impairment charge, to their estimated fair values. During the years ended December 31, 2023 and 2022, no impairment indicators have been identified. |
Treasury shares | i. Treasury shares: From time to time, forfeited equity grants will be transferred to the Company and the Company holds them as treasury shares. The Company presents the cost to repurchase treasury shares as a reduction of shareholders’ equity. |
Share-based compensation | j. Share-based compensation: The Company accounts for share-based compensation in accordance with ASC No. 718, “Compensation - Stock Compensation”, which requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the award is recognized as an expense over the requisite service periods, which is the vesting period of the respective award, on a straight-line basis when the only condition to vesting is continued service. The Company has selected the binominal option-pricing model as the most appropriate fair value method for its option awards. The fair value of restricted shares is based on the closing market value of the underlying shares at the date of grant. The Company recognizes forfeitures of equity-based awards as they occur. |
Accounts receivable | k. Accounts receivable: Accounts receivable are recorded net of credit losses allowance for any potential uncollectible amounts. The Company’s accounts receivable balance consists of amounts due from product sales to a single customer which is the Company’s sole distributor of Omisirge in the United States. The Company makes estimates of expected credit and collectability trends for the allowance for credit losses based upon its assessment of various factors, the age of the trade receivable balances, credit quality of its customers, current economic conditions, reasonable and supportable forecasts of future economic conditions, and other factors that may affect its ability to collect from customers. As of December 31, 2023 no allowances for credit losses of trade receivable were recorded. |
Employee benefit liabilities | l.Employee benefit liabilities: 1.Severance payThe majority of the Company’s employees who are Israeli citizens have subscribed to Section 14 of Israel’s Severance Pay Law, 5723-1963 (the “Severance Pay Law”). Pursuant to Section 14 of the Severance Pay Law, employees covered by this section are entitled to monthly deposits at a rate of 8.33% of their monthly salary, made on their behalf by the Company. Payments made to employees in accordance with this section release the Company from any future severance liabilities with respect to such employees. Neither severance pay liability nor severance pay fund under Section 14 of the Severance Pay Law is recorded on the Company’s consolidated balance sheets.For the Company’s employees in Israel who are not subject to Section 14 of the Severance Pay Law, the Company has a liability for severance pay pursuant to the Severance Pay Law based on the most recent salary of these employees multiplied by the number of years of employment as of the balance sheet date. Accrued severance pay for these employees was $1,482 and $1,914 as of December 31, 2023 and 2022, respectively. The Company’s liability for these employees is fully provided for by monthly deposits with severance pay funds, insurance policies and accruals. The deposited funds include profits accumulated up to the balance sheet date. The deposited funds may be withdrawn only upon the fulfillment of the obligation pursuant to the Severance Pay Law or labor agreements. The severance pay fund amounted to $1,359 and $1,703 as of December 31, 2023 and 2022, respectively.Severance expense for the years ended December 31, 2023 and 2022, was $483 and $895, respectivelyThe Company offers a defined contribution 401(k) plan (the “Plan”) covering all eligible US employees. Participants are permitted to make contributions up to the maximum amount allowed under the Internal Revenue Code. The Company’s contributions to the Plan for the years ended December 31, 2023 and 2022 were $515 and $424, respectively. |
Fair value of financial instruments | m. Fair value of financial instruments: The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable inputs that are based on inputs not quoted on active markets but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data are available. |
Leases | n. Leases: The Company accounts for leases according to ASC 842, “Leases”. The Company determines if an arrangement is a lease and the classification of that lease at inception based on: (1) whether the contract involves the use of a distinct identified asset, (2) whether the Company obtains the right to substantially all the economic benefits from the use of the asset throughout the period, and (3) whether the Company has a right to direct the use of the asset. The Company elected the practical expedient for lease agreements with a term of twelve months or less and does not recognize right-of-use (“ROU”) assets and lease liabilities in respect of those agreements. The Company also elected the practical expedient to not separate lease and non-lease components for its leases. An ROU asset represents the right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease agreement. An ROU asset is measured based on the discounted present value of the remaining lease payments, plus any initial direct costs incurred and prepaid lease payments, excluding lease incentives. The lease liability is measured at lease commencement date based on the discounted present value of the remaining lease payments. The implicit rate within the operating leases is generally not determinable, therefore the Company uses the Incremental Borrowing Rate (“IBR”) based on the information available at commencement date in determining the present value of lease payments. The Company’s IBR is estimated to approximate the interest rate for collateralized borrowing with similar terms and payments and in economic environments where the leased asset is located. Certain leases include options to extend the lease. An option to extend the lease is considered in connection with determining the ROU asset and lease liability when it is reasonably certain that the Company will exercise that option. An option to terminate is considered unless it is reasonably certain that the Company will not exercise the option. Payments under the Company’s lease arrangements are primarily fixed however, certain lease agreements contain variable payments, which are expensed as incurred and not included in the operating lease right-of-use assets and liabilities. Variable lease payments are primarily comprised of payments affected by common area maintenance and utility charges. |
Inventories | o. Inventories: Inventories are stated at the lower of cost or net realizable value; cost is determined using the average cost method. The Company regularly evaluates its ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand of the Company’s therapies deteriorates, or if market conditions are less favorable than those projected, inventory reserves or write-offs may be required. As of December 31, 2023, a reserve for slow-moving inventory approaching expiration dates and inventory write-offs of $357 was recorded. |
Revenue recognition | p. Revenue recognition: Revenues are recognized in accordance with ASC 606. Revenue from contracts with customers is recognized when control of the promised goods or services is transferred to the customers, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company’s revenues are comprised of product revenue which represents the sales of Omisirge. The Company has a sole distributor in the United States and sells to this customer. To determine revenue recognition for arrangements the Company determines that are within the scope of Topic 606, the Company performs the following five steps: (i) Identify the contract(s) with a customer: The Company enters into an enforceable contract with customer that defines each party’s rights regarding delivery of and payment for a Product, (ii) the contract has commercial substance and (iii) the Company determines that collection of substantially all consideration for such Product is probable based on the payer’s intent and ability to pay the promised consideration. (ii) Identify the performance obligations in the contract: The Company’s contracts include the sale and delivery of Omisirge, which represent the Company’s single performance obligation under each contract. (iii) Determine the transaction price: The transaction price is determined based on the consideration to which the Company will be entitled in exchange for providing a Product to the customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Product revenues are recognized at the time of delivery to the transplant center. (iv) Allocate the transaction price to the performance obligations in the contract: The entire transaction price is allocated to the single performance obligation. (v) Recognize revenue when (or as) the entity satisfies a performance obligation: Revenue is recognized when or as performance obligations are satisfied by transferring control of a promised good or service to a customer. Control either transfers over time or at a point in time, which affects when revenue is recorded. Revenues from sales of products are recognized at a point in time based on the transfer of control of the product, which is 24 hours after delivery to a transplant center. The Company applied the practical expedient in ASC 606 and did not evaluate payment terms of one year or less for the existence of a significant financing component. For the year ended December 31, 2023 all of the company’s revenues were incurred in USA and the payment terms are typically 95 days based on customary practices. |
Research and development expenses | q. Research and development expenses: Research and development expenses net of grants are recognized in the consolidated statements of operations when incurred. Research and development expenses consist of personnel costs (including salaries, benefits and share-based compensation), materials, consulting fees and payments to subcontractors, costs associated with obtaining regulatory approvals, and executing preclinical and clinical studies. In addition, research and development expenses include overhead allocations consisting of various administrative and facilities related costs. The Company charges research and development expenses as incurred. Royalty-bearing grants from the Israeli Innovation Authority (the “IIA”) of the Ministry of Economy and Industry in Israel for funding of approved research and development projects are recognized at the time the Company is entitled to such grants, on the basis of the costs incurred, and are presented as a reduction from research and development expenses. In the event of failure of a project that was partly financed by the IIA, the Company will not be obligated to pay any royalties or repay the amounts received. The Company recognized the amounts of grants received in research and development as a reduction from research and development expenses in the amount of $309 and $978 for the years ended December 31, 2023 and 2022, respectively. |
Cost of sales | r. Cost of Sales: Cost of sales includes direct costs attributable to the production of Omisirge. Cost of sales includes raw materials, production, labor, and certain maintenance and indirect manufacturing overheads costs, quality testing directly related to the product, and depreciation on equipment used in the manufacturing of Omisirge. It also includes any cost of batch failure losses and royalty expenses. Cost of sales for Omisirge are recognized when batch failure or revenue is recognized. |
Excess Capacity | s. Excess Capacity: Excess capacity costs reflect labor and manufacturing overhead costs incurred above the amount of these costs absorbed in cost of sales as part of standard costs, which are based on staffed capacity levels, given that the Kiryat Gat facility is staffed to produce the anticipated demand over the course of the coming year. |
Selling, General & Administrative (SG&A) | t. Selling, General & Administrative (SG&A): Beginning July 1, 2023, reporting of Operating Expenses has been modified to reflect the Company’s transition to commercial stage. Costs that were previously reported as Commercial and General & Administrative costs, are currently being reported as part of Selling, General & Administrative (SG&A) expenses. SG&A Costs consist mainly of personnel costs (including salaries, benefits and share-based compensation), supply chain and quality assurance indirect expenses, medical affairs expenses, marketing and selling, finance, and legal expenses. |
Income taxes | u. Income taxes: The Company accounts for income taxes in accordance with ASC 740, “Income Taxes”, which prescribes the use of the liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, to reduce deferred tax assets to their estimated realizable value, if needed. ASC 740 offers a two-step approach for recognizing and measuring a liability for uncertain tax positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. Any interest and penalties related to unrecognized tax benefits are recorded as income tax expense. As of December 31, 2023 and 2022, no liability for unrecognized tax benefits was recorded as a result of ASC 740. |
Basic and diluted net loss per share | v. Basic and diluted net loss per share: The Company computes net loss per share using the two-class method required for participating securities. The two-class method requires income available to ordinary shareholders for the period to be allocated between ordinary shares and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. The Company considers its restricted shares to be participating securities as the holders of the restricted shares would be entitled to dividends that would be distributed to the holders of ordinary shares, on a pro-rata basis. These participating securities do not contractually require the holders of such shares to participate in the Company’s losses. As such, net loss for the periods presented was not allocated to the Company’s participating securities. The Company’s basic net loss per share is calculated by dividing net loss attributable to ordinary shareholders by the weighted average number of ordinary shares outstanding for the period, without consideration of potentially dilutive securities. The diluted net loss per share is calculated by giving effect to all potentially dilutive securities outstanding for the period using the treasury share method or the if-converted method for the convertible senior notes if the assumed conversion into ordinary shares is dilutive. Diluted net loss per share is the same as basic net loss per share in periods when the effects of potentially dilutive ordinary shares are antidilutive. |
Recently adopted accounting standards | w. Recently adopted accounting standards: In June 2016, FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the more timely recognition of losses. Topic 326 is effective for the Company beginning on January 1, 2023. Effective January 1, 2023, the Company adopted the standard. Adoption of the standard did not have material impact on the financial statements. |
Recently issued accounting pronouncements not yet adopted | x. Recently issued accounting pronouncements not yet adopted: In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. For the Company, ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09. |