TAXES ON INCOME

9 Months Ended

Sep. 30, 2023

TAXES ON INCOME

TAXES ON INCOME

NOTE 7 – TAXES ON INCOME

The following table summarizes the Company’s taxes on income:

	Three Months Ended		Nine Months Ended
(U.S. dollars in thousands)	September 30, 2023		September 30, 2023
Current taxes on income	$	95	$	3,728
Deferred taxes on income		38		(3,092)
Total taxes on income	$	133	$	636

The Company had an effective tax rate of 4% for the nine months ended September 30, 2023, compared to an effective tax rate of 0% for the nine months ended September 30, 2022. For the nine months ended September 30, 2023, the difference between the Company’s effective tax rate and the U.S. federal statutory rate of 21% was the result of the provision for current taxes on income mainly derived from U.S. taxable GILTI income mainly in respect of milestone payments and Section 174 of the U.S. Tax Cuts and Jobs Act, which was enacted in December 2017 (the “TCJA”), partially offset by the release of the valuation allowance on net operating losses (NOLs) in the United States.

Following the regulatory approvals for Elfabrio in May 2023, the receipt of the $20.0 million milestone payment and the launch of Elfabrio in the United States, the Company released valuation allowance previously recorded on deferred tax assets in respect of its NOLs in the United States resulting in a net tax benefit of $3.1 million. The Company concluded that, based upon the preponderance of positive evidence over negative evidence and the anticipated ability to use the deferred tax assets, it was more likely than not that these deferred tax assets would be realizable due to forecasted profits. The Company considered the following: (i) cumulative profits for tax over the previous 12 quarters in its U.S. operations; (ii) the impact of

Section 174 of the TCJA which requires the Company to capitalize and amortize its research and development expenses over 15 years; and (iii) its forecasted profits in the United States following the regulatory approvals of Elfabrio.