0001104659-26-029858 | 10-K | XBRL Viewer | Protalix Biotherapeutics INC

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TAXES ON INCOME (Summary of Taxes on Income) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
TAXES ON INCOME
Current taxes on income - US (federal)	$ 656	$ 986	$ 3,346
Deferred taxes on income - US (federal)	340	236	(3,092)
Total taxes on income	$ 996	$ 1,222	$ 254

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

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+ Details

INVENTORIES (Schedule of Inventory) (Details) - USD ($) $ in Thousands	Dec. 31, 2025	Dec. 31, 2024
INVENTORIES
Raw materials	$ 5,980	$ 4,549
Work in progress	9,375	11,245
Finished goods	10,374	5,449
Total inventory	$ 25,729	$ 21,243

PROPERTY AND EQUIPMENT

12 Months Ended

Dec. 31, 2025

PROPERTY AND EQUIPMENT

PROPERTY AND EQUIPMENT

NOTE 3 - PROPERTY AND EQUIPMENT

Composition of property and equipment grouped by major classifications is as follows:

Composition of property and equipment grouped by major classifications is as follows:
		December 31,
(U.S. dollars in thousands)		2024			2025
Laboratory equipment		$	19,043		$	20,090
Furniture and computer equipment			3,374			3,765
Leasehold improvements			17,913			18,070
		$	40,330		$	41,925
Less – accumulated depreciation and amortization			(35,739)			(37,046)
		$	4,591		$	4,879

Depreciation in respect of property and equipment during the years ended December 31, 2023, 2024, and 2025 were as follows:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Depreciation in respect of property and equipment		$	1,191		$	1,304		$	1,465

COMMERCIALIZATION AGREEMENTS

12 Months Ended

Dec. 31, 2025

COMMERCIALIZATION AGREEMENTS

COMMERCIALIZATION AGREEMENTS

NOTE 2 - COMMERCIALIZATION AGREEMENTS

In October 2015, the Company entered into the Amended Pfizer Agreement with Pfizer that amended and restated the Pfizer Agreement of November 30, 2009. Pursuant to the amendment, the Company granted Pfizer an exclusive, worldwide license, excluding Brazil. Pfizer acquired all the information, knowledge and permission to manufacture and sell Elelyso.

Protalix Ltd. also agreed to provide Pfizer with:

1.Manufacturing and supply of the drug substance for its incorporation into the licensed product in consideration of an agreed price per unit.

2.Assistance in arranging for the manufacture of the drug substance by Pfizer or by alternative supplier chosen by Pfizer in consideration of an agreed hourly rate plus reimbursement of expenses.

b. In October 2017, Protalix Ltd. entered into the Chiesi Ex-U.S. Agreement with respect to the commercialization of pegunigalsidase alfa (hereafter – the drug) for the treatment of Fabry disease. Under the terms of the Chiesi Ex-U.S. Agreement, Protalix Ltd. granted to Chiesi exclusive licensing rights for the commercialization of the drug for all markets outside of the United States. At the effective date, Protalix Ltd. had maintained the exclusive commercialization rights to the drug in the United States, which rights were subsequently granted to Chiesi in July 2018.

Protalix Ltd. is mainly responsible for (i) continuing the development of the drug until a regulatory approval is granted and (ii) manufacture and supply the drug to Chiesi, based on Chiesi’s requests.

The consideration consists of the following:

Upfront, non-refundable payment of $25.0 million.

Additional payments of up to $25.0 million in development costs, capped at $10.0 million per year.

Payments for additional studies, as may be approved from time to time by Chiesi.

Milestone payments of up to $320.0 million with respect to certain regulatory and commercial events as defined in the Chiesi Ex-U.S. Agreement, which has been reduced to $295.0 million.

Additional payments as consideration for the supply of the drug. The payment will vary from 15% to 35% of Chiesi’s average selling price of the drug, depending on the amount of annual sales.

Protalix Ltd. will be the sole manufacturer of the drug.

Chiesi does not have sublicensing rights (except for certain territories).

In July 2018, Protalix Ltd. entered into the Chiesi US Agreement with respect to the commercialization of the drug for the treatment of Fabry disease. Under the terms of the Chiesi US Agreement, Protalix Ltd. granted to Chiesi exclusive licensing rights for the commercialization of the drug for all markets in the United States. Protalix Ltd. is mainly responsible for (i) continuing the development of the drug until a regulatory approval is granted, (ii) continuing certain clinical development efforts in relation to the drug after a regulatory approval is granted and (iii) manufacture and supply the drug to Chiesi, based on Chiesi’s requests.

The consideration consists of the following:

Upfront, non-refundable payment of $25.0 million.

Additional payments of up to $20.0 million in development costs, capped at $7.5 million per year.

Payments for additional studies, as may be approved from time to time by Chiesi.

Milestone payments of up to $760.0 million with respect to certain regulatory and commercial events as defined in the Chiesi US Agreement.

Additional payments as consideration for the supply of the drug. The payment will vary from 15% to 40% of Chiesi’s average selling price of the drug, depending on the amount of annual sales.

Protalix will be the sole manufacturer of the drug.

Chiesi does not have sublicensing rights.

On June 18, 2013, Protalix Ltd. entered into the Brazil Agreement with Fiocruz for BioManguinhos. Fiocruz’s purchases of BioManguinhos alfataliglicerase to date have been significantly below certain agreed upon purchase milestones and, accordingly, the Company has the right to terminate the Brazil Agreement. Notwithstanding, the Company is, at this time, continuing to supply BioManguinhos alfataliglicerase to Fiocruz under the Brazil Agreement, and patients continue to be treated with BioManguinhos alfataliglicerase in Brazil.

SHARE CAPITAL (Additional Information) (Details) $ / shares in Units, $ in Thousands	12 Months Ended			21 Months Ended
	Dec. 31, 2025 USD ($) Vote $ / shares shares	Dec. 31, 2024 USD ($) $ / shares shares	Dec. 31, 2023 USD ($) shares	Mar. 31, 2023 USD ($) shares	Mar. 17, 2025 USD ($)	Mar. 12, 2025 shares	Feb. 27, 2023 USD ($)	Jul. 02, 2021 USD ($)
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, authorized \| shares	185,000,000	185,000,000
Common stock par value \| $ / shares	$ 0.001	$ 0.001
Preferred stock, authorized \| shares	100,000,000
Preferred stock par value \| $ / shares	$ 0.0001
Number of voting rights \| Vote	1
Shares of Common Stock remain available for grant under the plan \| shares	2,092,933
Stock issuance proceeds	$ 6,812	$ 3,626	$ 23,954
Plan
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares authorized for issuance under share-based payment arrangement \| shares	17,475,171
Private Placement
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares issued (in shares) \| shares	908,000		301,810
Proceeds from Warrant Exercises	$ 2,100		$ 700
Exercise of warrants (in shares) \| shares			237,012
Number of warrants issued (in shares) \| shares			845,000
Warrants and rights outstanding \| shares						0
Private Placement \| 2024 Notes
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Converted instrument, shares issued \| shares			4,691,623
Paid to the converting holders			$ 900
ATM Shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares issued (in shares) \| shares			12,560,150
Stock issuance proceeds			$ 24,900
Payments of Stock Issuance Costs			$ 900
2021 Sales Agreement
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares issued (in shares) \| shares				13,980,060
Sale of stock, maximum offering price								$ 20,000
Stock issuance proceeds				$ 20,000
2023 Sales Agreement
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares issued (in shares) \| shares	2,775,215	2,216,692
Sale of stock, maximum offering price							$ 20,000
Increase in aggregate gross sales price					$ 20,000
Shares remain available, total gross proceeds	$ 15,700
Stock issuance proceeds	7,000	$ 3,800
Payments of Stock Issuance Costs	$ 200	$ 100
2023 Sales Agreement \| Maximum
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Commission (as a percent)	3.00%
Options and restricted shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Term of award	10 years
Options and restricted shares \| Minimum
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Vesting period	3 years
Options and restricted shares \| Maximum
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Vesting period	4 years
Employee Stock Option
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Outstanding options intrinsic value	$ 3,400
Exercisable options intrinsic value	2,300
Unrecognized compensation cost	$ 1,300
Unrecognized weighted average period	10 months 2 days
Exercise of options \| shares	328,481	0	0
Employee Stock Option \| Private Placement
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Exercise of options \| shares	328,481
Cash proceeds from stock options exercised	$ 400
Restricted Stock
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Unrecognized compensation cost	$ 700
Unrecognized weighted average period	10 months 13 days
Vesting-date fair value of stock vested	$ 1,300

TAXES ON INCOME (Uncertain Tax Position) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
TAXES ON INCOME
Beginning balance	$ 805	$ 805	$ 530
Increase for tax position related to current year	0	0	275
Ending Balance	$ 805	$ 805	$ 805

SEGMENT INFORMATION (Schedule of Segment Information) (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2025 USD ($) segment	Dec. 31, 2024 USD ($)	Dec. 31, 2023 USD ($)
SEGMENT INFORMATION
Number of Operating Segments \| segment	1
Number of reportable segments not disclosed	true
Revenues from customers	$ 52,744	$ 53,399	$ 65,494
Depreciation	1,465	1,304	1,191
INCOME (LOSS) BEFORE TAXES ON INCOME	(5,608)	4,154	8,566
Taxes on income	996	1,222	254
NET INCOME (LOSS)	$ (6,604)	$ 2,932	$ 8,312
Segment reporting description	Other expenses included in net income (loss) includes raw materials, rent and utilities and others.	Other expenses included in net income (loss) includes raw materials, rent and utilities and others.	Other expenses included in net income (loss) includes raw materials, rent and utilities and others.
Single operating segment
SEGMENT INFORMATION
Revenues from customers	$ 52,744	$ 53,399	$ 65,494
Employee salaries and related expenses	24,722	21,780	24,075
Sub-contractors expense	12,275	8,682	14,008
Interest expense		1,062	3,180
Interest income	(1,083)	(1,299)	(1,286)
Depreciation	1,465	1,304	1,191
Other segment expenses	20,973	17,716	15,760
INCOME (LOSS) BEFORE TAXES ON INCOME	(5,608)	4,154	8,566
Taxes on income	996	1,222	254
NET INCOME (LOSS)	$ (6,604)	$ 2,932	$ 8,312

INVENTORIES (Write-Down of Inventory) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
INVENTORIES
Write-down of inventory under cost of goods sold	$ 30	$ 90	$ 800

SHARE CAPITAL

12 Months Ended

Dec. 31, 2025

SHARE CAPITAL

SHARE CAPITAL

NOTE 8 - SHARE CAPITAL

a. Authorized Capital

Under the Company’s Certificate of Incorporation, as amended, the Company is authorized to issue 185,000,000 shares of Common Stock, par value $0.001 per share, and 100,000,000 shares of preferred stock, par value $0.0001 per share.

b.Rights of the Company’s Common Stock

The Company’s Common Stock is listed on the NYSE American. The Company voluntarily delisted its Common Stock from the Tel Aviv Stock Exchange effective March 22, 2023. Each share of Common Stock is entitled to one vote. The holders of shares of Common Stock are also entitled to receive dividends whenever funds are legally available, when and if declared by the Board of Directors. Since its inception, the Company has not declared any dividends.

c. Stock based compensation

On December 14, 2006, the Board of Directors adopted the Protalix BioTherapeutics, Inc. 2006 Stock Incentive Plan, as amended (the “Plan”). The Plan has since been amended to, among other things, increase the number of shares of Common Stock available under the Plan to 17,475,171 shares. The grant of options to Israeli employees under the Plan is subject to the terms stipulated by Sections 102 and 102A of the Israeli Income Tax Ordinance (the “Ordinance”). Each option grant made to an Israeli citizen is subject to the track chosen by the Company, either Section 102 or Section 102A of the Ordinance, and pursuant to the terms thereof, the Company is not allowed to claim, as an expense for tax purposes, the amounts credited to employees as a benefit, including amounts recorded as salary benefits in the Company’s accounts, in respect of options granted to employees under the Plan, with the exception of the work-income benefit component, if any, determined on the grant date. For Israeli non-employees, the share option plan is subject to Section 3(i) of the Ordinance.

As of December 31, 2025, 2,092,933 shares of Common Stock remain available for grant under the Plan.

The vesting period of the outstanding options and restricted shares is generally three or four years from the date of grant. The rights of common stock obtained from the exercise of options (once vested) and the restricted stock are identical to those of other common stock of the Company. The contractual term of these options is primarily for ten years.

1. Options and restricted stock granted to employees and directors:

A summary of share option plans, and related information, under all of the Company’s equity incentive plans for the year ended December 31, 2025, and the effect of share-based compensation on the statement of operations for the year ended December 31, 2025, is as follows:

Options granted to employees and directors:


	Year ended December 31, 2025
			Weighted
	Number		average
	of		exercise
	options		price
Outstanding at beginning of year	7,402,295		$	1.98
Changes during the year:
Granted	1,458,990			1.56
Expired and forfeited	(258,526)			7.53
Exercised	(328,481)			1.13
Outstanding at end of year	8,274,278		$	1.76
Exercisable at end of year	5,464,917		$	1.94

Restricted stock granted to employees and directors:


	Year Ended December 31, 2025
			Weighted
	Number of		average
	Restricted		of fair value
	Stock		at grant date
Outstanding at beginning of year	862,816	$	1.70
Changes during the year:
Granted	564,010		1.66
Vested	(687,232)	$	1.81
Non vested at end of year	739,594	$	1.58

The following table summarizes information concerning outstanding and exercisable options as of December 31, 2025:


		December 31, 2025
		Options outstanding				Options exercisable
		Number of		Weighted				Weighted
		options		average				average
		outstanding		remaining		Number of		remaining
Exercise		at end of		contractual		options		contractual
prices		year		life		exercisable		life
$1.03-$2.00		7,017,970		7.44		4,208,609		6.64
$3.55-$3.73		836,308		3.65		836,308		3.65
$4.69-$5.60		420,000		2.76		420,000		2.76
		8,274,278				5,464,917

As of December 31, 2025, the aggregate intrinsic value of all the outstanding options and exercisable options was approximately $3.4 million and $2.3 million, respectively.

The weighted average grants date per share fair value of restricted stock granted in 2023, 2024, and 2025 was as follows:


		Year ended December 31,
		2023			2024			2025
Weighted average grants date per share fair value (USD)		$	1.99		$	1.24		$	1.66

The fair value of each option granted during 2023, 2024, and 2025 for both employees and directors is estimated at the date of grant using the Black-Scholes option-pricing model. The following weighted average assumptions were applied in determining the options’ fair value on their grant date:


	Year Ended December 31,
	2023		2024		2025
Weighted average grants date fair value (USD)	1.84		1.10		1.56
Exercise price (USD)	1.84		1.10		1.56
Risk free rate	4.44	%	3.55	%	3.89	%
Volatility	79.41	%	79.29	%	73.64	%
Dividend yield	0	%	0	%	0	%
Expected life (Years)	5.75		5.75		5.75

The total unrecognized compensation cost of employee stock options at December 31, 2025 is approximately $1.3 million. The unrecognized compensation cost of employee stock options is expected to be recognized over a weighted average period of 0.84 years.

During the years ended December 31, 2023 and 2024, there were no exercises of stock options, and the Company did not realize any tax benefit in connection with any exercises. During the year ended December 31, 2025, employees and former employees exercised options to purchase 328,481 shares of the Company’s common stock in the aggregate, and the Company did not realize any tax benefits equal in connection with such exercises.

The total vesting-date value of equity classified restricted stock vested during the year ended December 31, 2025 was $1.3 million. As of December 31, 2025, the unrecognized compensation cost related to all unvested equity classified restricted stock of $0.7 million is expected to be recognized as an expense over a weighted-average period of 0.87 years.

The following table illustrates the effect of share-based compensation on the statement of operations:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Cost of goods sold		$	596		$	631		$	431
Research and development expenses			777			589			680
Selling, general, and administrative expenses			2,075			2,033			1,186
		$	3,448		$	3,253		$	2,297

d. Private and 144A Offerings

During the year ended December 31, 2023, the Company issued (i) 301,810 shares of Common Stock in connection with the cash exercise of a warrant issued in 2020 and generated proceeds equal to $0.7 million from such exercise and (ii) 237,012 shares of Common Stock in connection with the cashless exercise of a warrant to purchase 845,000 shares of Common Stock issued in 2020. The Company did not generate any proceeds from the cashless exercise.

During the year ended December 31, 2023, the Company issued, in the aggregate, 4,691,623 shares of Common Stock in connection with the conversions of 2024 Notes. In connection with such conversions, during the year ended December 31, 2023, the Company paid to the converting holders $0.9 million representing cash payments due to accrued but unpaid interest, make-whole interest payments and payments in lieu of fractional shares.

During the year ended December 31, 2025, the Company issued:

(i)

908,000 shares of Common Stock in connection with the exercise of warrants issued in 2020 generating proceeds equal to approximately $2.1 million from such exercises. All unexercised warrants expired on March 11, 2025. Accordingly, as of March 12, 2025, no warrants remained outstanding.

(ii)

328,481 shares of Common Stock in connection with the cash exercise of options to purchase 328,481 shares of Common Stock by certain current and former employees of the Company. The Company received cash proceeds equal to $0.4 million in connection with such exercises.

e. At-the-Market (ATM) Offering

On July 2, 2021, the Company entered into an At The Market Offering Agreement (the “2021 Sales Agreement”) with H.C. Wainwright & Co., LLC, as the Company’s sales agent (the “Agent”) which was amended on May 2, 2022. Pursuant to the terms of the 2021 Sales Agreement, the Company was able to sell from time to time through the Agent, shares of Common Stock having an aggregate offering price of up to $20.0 million (the “ATM Shares”). During the term of the 2021 Sales Agreement which ended during the quarter ended March 31, 2023, the Company sold a total of 13,980,060 ATM Shares for total gross proceeds of approximately $20.0 million, thereby completing the ATM program under said agreement.

On February 27, 2023, the Company entered into an At The Market Offering Agreement (the “2023 Sales Agreement”) with the Agent. Pursuant to the terms of the 2023 Sales Agreement, the Company may sell, from time to time through the Agent, ATM Shares having an aggregate offering price of up to $20.0 million. On March 17, 2025, the Company entered into an amendment to the 2023 Sales Agreement pursuant to which the Company increased the aggregate gross sales price of shares of Common Stock available for offer and sale under the Sales Agreement by $20.0 million.

The Company has no obligation to sell any shares of Common Stock under the 2023 Sales Agreement, and may at any time suspend sales under the 2023 Sales Agreement or terminate the 2023 Sales Agreement in accordance with its terms. The Agent is entitled to a commission of up to 3.0% of the aggregate gross proceeds from the shares of Common Stock sold under the 2023 Sales Agreement.

During the year ended December 31, 2023, the Company sold, in the aggregate, 12,560,150 shares of Common Stock under the 2021 Sales Agreement and 2023 Sales Agreement. The Company generated gross proceeds equal to approximately $24.9 million in connection with such sales (issuance cost was approximately $0.9 million).

During the year ended December 31, 2024, the Company sold, in the aggregate 2,216,692 shares of Common Stock under the 2023 Sales Agreement. The Company generated gross proceeds equal to approximately $3.8 million in connection with such sales (issuance cost was approximately $0.1 million).

During the year ended December 31, 2025, the Company sold, in the aggregate, 2,775,215 shares of Common Stock under the 2023 Sales Agreement. The Company generated gross proceeds equal to approximately $7.0 million in connection with such sales (issuance costs were $0.2 million). All such sales were effected during the first and second quarters of 2025.

As of December 31, 2025, shares of Common Stock for total gross proceeds of approximately $15.7 million remain available to be sold under the Sales Agreement.

- Definition

The entire disclosure for equity.

+ References

+ Details

Insider Trading Policies and Procedures	12 Months Ended
Insider Trading Policies and Procedures	Dec. 31, 2025
Insider Trading Policies and Procedures [Line Items]
Insider Trading Policies and Procedures Adopted	true

INVENTORIES (Tables)

12 Months Ended

Dec. 31, 2025

INVENTORIES

Schedule of Inventory

Inventories at December 31, 2024 and 2025 consisted of the following:


	December 31,
(U.S. dollars in thousands)	2024		2025
Raw materials	$	4,549	$	5,980
Work in progress		11,245		9,375
Finished goods		5,449		10,374
Total inventory	$	21,243	$	25,729

Schedule of Write-down of Inventory

Write-down of inventory under cost of goods sold recorded during the years ended December 31, 2023, 2024, and 2025 were as follows:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Write-down of inventory under cost of goods sold		$	800		$	90		$	30

SIGNIFICANT ACCOUNTING POLICIES (Schedule of Accounts Receivables) (Details) - USD ($) $ in Thousands	Dec. 31, 2025	Dec. 31, 2024
Significant Accounting Policies [Line Items]
Accounts receivable	$ 8,840	$ 2,909
Chiesi
Significant Accounting Policies [Line Items]
Accounts receivable	5,473
Pfizer
Significant Accounting Policies [Line Items]
Accounts receivable	1,426	1,192
Fiocruz
Significant Accounting Policies [Line Items]
Accounts receivable	$ 1,941	$ 1,717

CONVERTIBLE NOTES (Tables)

12 Months Ended

Dec. 31, 2025

2024 Notes

Schedule of Interest Expense Recognized

The following table sets forth total interest expense recognized related to the 2024 Notes:


	Year Ended December 31,
(U.S. dollars in thousands)	2023			2024
Contractual interest expense	$	2,534		$	1,022
Amortization of debt issuance costs and debt discount		267			—
Total	$	2,801		$	1,022

RELATED PARTY TRANSACTIONS (Tables)

12 Months Ended

Dec. 31, 2025

RELATED PARTY TRANSACTIONS

Schedule of Related Party Transactions

Non-Executive Director Compensation


		Year Ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Compensation (including share-based compensation) to the non-executive directors		$	429		$	555		$	478

TAXES ON INCOME (Tables)

12 Months Ended

Dec. 31, 2025

TAXES ON INCOME

Schedule of Deferred Tax Assets

The components of the Company’s net deferred tax assets at December 31, 2024 and 2025 were as follows:


		December 31,
(U.S. dollars in thousands)		2024			2025
In respect of:
Research and development expenses		$	3,055		$	3,717
Other timing differences			452			684
Net operating loss carry forwards			50,014			48,479
Valuation allowance			(50,665)			(50,364)
			2,856			2,516

Schedule of Reconciliation of Tax Expense

A reconciliation of the statutory U.S. federal income tax rate of 21% in 2025 to the effective income tax rate is as follows:


		Year Ended December 31, 2025
(U.S. dollars in thousands)		$		%
U.S Federal Statutory tax rate			(1,178)	(21)
Foreign Tax Effects (Israel):
Change in Valuation allowances			(301)	(5)
Share based compensation			528	9
Other			(10)	-
Effect of changes in tax law enacted in the current period			105	2
Effect of Cross Border Tax Laws, net			1,735	31
Non-taxable or non-deductible items			117	2
Effective tax rate			996	18

A reconciliation of the statutory U.S. federal income tax rate of 21% in 2024 and 2023 to the effective income tax rate is as follows:


		Year Ended December 31,
(U.S. dollars in thousands)		2023			2024
Tax computed at the statutory U.S. income tax rate		$	1,799		$	872
Differences in tax rate			(899)			(436)
Statutorily non-deductible expenses			1,684			506
Change in Valuation allowances			(6,932)			(953)
Utilization of carry-forward losses and other temporary items without deferred taxes recognition			3,602			1,233
Withholding tax			1,000			-
		$	254		$	1,222

Schedule of Company's Valuation Allowance

The following table presents the change in the Company’s valuation allowance during the periods presented:


(U.S. dollars in thousands)
Balance at December 31, 2022	$	(58,550)
Additions to valuation allowance		(728)
Reductions to valuation allowance		7,660
Balance at December 31, 2023	$	(51,618)

Balance at December 31, 2023	$	(51,618)
Reductions to valuation allowance		953
Balance at December 31, 2024	$	(50,665)

Balance at December 31, 2024	$	(50,665)
Reductions to valuation allowance		301
Balance at December 31, 2025	$	(50,364)

Schedule of Reconciliation of the Beginning and Ending Amount of Unrecognized Tax Benefits

Provisions of ASC 740-10, Income Taxes, clarify whether to recognize assets or liabilities for tax positions taken that may be challenged by a tax authority. A reconciliation of the beginning and ending amount of unrecognized tax benefits, is as follows:


(U.S. dollars in thousands)
Balance at December 31, 2022	$	530
Increase for tax position related to current year		275
Balance at December 31, 2023	$	805

Balance at December 31, 2023	$	805
Increase for tax position related to current year		-
Balance at December 31, 2024	$	805

Balance at December 31, 2024	$	805
Increase for tax position related to current year		-
Balance at December 31, 2025	$	805

Schedule of Open Tax Years

A summary of open tax years by major jurisdiction is presented below:


Jurisdiction:		Years:
Israel		2021-2025
United States (*)		2022-2025

(*)	Includes federal, state and local (or similar provincial jurisdictions) tax positions.

Schedule of Income (loss) before taxes

i. Income (loss) before taxes on income is composed of the following:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Domestic			(7,061)			(4,548)			(4,579)
Foreign			15,627			8,702			(1,029)
		$	8,566		$	4,154		$	(5,608)

Schedule of Taxes on Income

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


			Year Ended December 31,
(U.S. dollars in thousands)		2023		2024		2025
Current taxes on income - US (federal)		$	3,346	$	986	$	656
Deferred taxes on income - US (federal)			(3,092)		236		340
Total taxes on income		$	254	$	1,222	$	996

Schedule of Income taxes paid

The income taxes paid by the Company are as follows:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
United States (federal)		$	-		$	385		$	1,183

NET EARNINGS (LOSS) PER SHARE (Tables)

12 Months Ended

Dec. 31, 2025

NET EARNINGS (LOSS) PER SHARE

Schedule of Basic and Diluted Net Earnings (Loss) per Share

Basic and diluted net earnings (loss) per share attributable to common stockholders were calculated as follows:


		Year Ended December 31,
(In thousands, except share data)		2023	2024			2025
Numerator:
Net income (loss)	$	8,312	$	2,932		$	(6,604)
Add:
Financial expenses of 2024 Notes*		(1,168)		39
Net income (loss) for diluted calculation	$	7,144	$	2,971		$	(6,604)
Denominator:
Weighted average shares of Common Stock outstanding for basic calculation		67,512,527		72,530,698			78,546,234
Weighted average dilutive effect of 2024 Notes		13,335,430		7,667,323
Weighted average dilutive effect of stock options and restricted stock		1,576,059		859,155
Weighted average shares of Common Stock outstanding for diluted calculation		82,424,016		81,057,176			78,546,234

* Financial expenses on 2024 Notes consists of add back of financial expense incurred during the year and inclusion of make-whole interest payments that will be incurred upon conversion.

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Other Assets) (Details) - USD ($) $ in Thousands	Dec. 31, 2025	Dec. 31, 2024
Other assets:
Institutions	$ 634	$ 486
Prepaid expenses	394	500
Sundry	101	110
Other assets	$ 1,129	$ 1,096

INVENTORIES

12 Months Ended

Dec. 31, 2025

INVENTORIES

INVENTORIES

NOTE 4 - INVENTORIES

Inventories at December 31, 2024 and 2025 consisted of the following:


	December 31,
(U.S. dollars in thousands)	2024		2025
Raw materials	$	4,549	$	5,980
Work in progress		11,245		9,375
Finished goods		5,449		10,374
Total inventory	$	21,243	$	25,729

Write-down of inventory under cost of goods sold recorded during the years ended December 31, 2023, 2024, and 2025 were as follows:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Write-down of inventory under cost of goods sold		$	800		$	90		$	30

COMMITMENTS (Tables)

12 Months Ended

Dec. 31, 2025

COMMITMENTS

Schedule of Royalty Commitments

Royalty expenses to NATI or the IIA are included in the statement of operations as a component of the cost of revenues during the years ended December 31, 2023, 2024, and 2025 were approximately as follows:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Royalty expenses to NATI or the IIA		$	1,868		$	1,582		$	1,557

The maximum total royalty amount payable by the Company under these funding arrangements at December 31, 2024 and 2025 (without interest, assuming 100% of the funds are payable) is as follows:


		December 31,
(U.S. dollars in thousands)		2024			2025
Maximum total royalty amount payable (without interest, assuming 100% of the funds are payable)		$	33,900		$	32,391

SIGNIFICANT ACCOUNTING POLICIES (Additional Information) (Details) $ / shares in Units, $ in Millions	1 Months Ended		12 Months Ended
	Oct. 31, 2025	May 31, 2023 USD ($)	Dec. 31, 2025 USD ($) item agreement $ / shares	Dec. 31, 2024 USD ($) $ / shares	Dec. 31, 2023 USD ($)	Sep. 30, 2024
SIGNIFICANT ACCOUNTING POLICIES
Number of global licensing and supply agreements \| agreement			2
Accounts receivables write-off			$ 0.0	$ 0.0
Accounts receivables recoveries			$ 0.0	$ 0.0
Common Stock, Par or Stated Value Per Share (in dollars per share) \| $ / shares			$ 0.001	$ 0.001
2024 Notes
SIGNIFICANT ACCOUNTING POLICIES
Interest rate (as a percent)						7.50%
Minimum
SIGNIFICANT ACCOUNTING POLICIES
Short-term deposits average annual rate			5.05%	5.05%
Maximum
SIGNIFICANT ACCOUNTING POLICIES
Short-term deposits average annual rate			5.75%	5.75%
Payment Terms			45 days
Amended Pfizer Agreement \| Protalix Bio Therapeutics Incorporation \| Brazil
SIGNIFICANT ACCOUNTING POLICIES
Collaborative arrangement revenues and expenses sharing percentage	100.00%
Chiesi Agreements
SIGNIFICANT ACCOUNTING POLICIES
Performance obligation number \| item			2
Amount of milestone payment received		$ 20.0			$ 20.0

PROPERTY AND EQUIPMENT (Depreciation) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
PROPERTY AND EQUIPMENT
Depreciation	$ 1,465	$ 1,304	$ 1,191

PROPERTY AND EQUIPMENT (Tables)

12 Months Ended

Dec. 31, 2025

PROPERTY AND EQUIPMENT

Schedule of Property and Equipment

Composition of property and equipment grouped by major classifications is as follows:

Composition of property and equipment grouped by major classifications is as follows:
		December 31,
(U.S. dollars in thousands)		2024			2025
Laboratory equipment		$	19,043		$	20,090
Furniture and computer equipment			3,374			3,765
Leasehold improvements			17,913			18,070
		$	40,330		$	41,925
Less – accumulated depreciation and amortization			(35,739)			(37,046)
		$	4,591		$	4,879

Depreciation in respect of property and equipment during the years ended December 31, 2023, 2024, and 2025 were as follows:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Depreciation in respect of property and equipment		$	1,191		$	1,304		$	1,465

SHARE CAPITAL (Schedule of Stock-Based Compensation Expense in Statement of Operations) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	$ 2,297	$ 3,253	$ 3,448
Cost of goods sold
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	431	631	596
Research and development expenses
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	680	589	777
Selling, general, and administrative expenses
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	$ 1,186	$ 2,033	$ 2,075

NET EARNINGS (LOSS) PER SHARE (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
Numerator:
Net income (loss)	$ (6,604)	$ 2,932	$ 8,312
Financial expenses of 2024 Notes		39	(1,168)
Net income (loss) for diluted calculation	$ (6,604)	$ 2,971	$ 7,144
Denominator:
Weighted average shares of Common Stock outstanding for basic calculation	78,546,234	72,530,698	67,512,527
Weighted average dilutive effect of 2024 Notes		7,667,323	13,335,430
Weighted average dilutive effect of stock options and restricted stock		859,155	1,576,059
Weighted average shares of Common Stock outstanding for diluted calculation	78,546,234	81,057,176	82,424,016
Outstanding Stock Options And Warrants
Denominator:
Antidilutive securities excluded from computation of earnings (loss) per share, amount			18,254,264
Outstanding Stock Options, Unvested Restricted Stock and Warrants
Denominator:
Antidilutive securities excluded from computation of earnings (loss) per share, amount	10,672,506	16,661,907

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Dec. 31, 2025
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Tables)

12 Months Ended

Dec. 31, 2025

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

Schedule of Supplemental Information of Balance Sheets


		December 31,
(U.S. dollars in thousands)		2024			2025
a. Other assets:
Institutions		$	486		$	634
Prepaid expenses			500			394
Sundry			110			101
		$	1,096		$	1,129


		December 31,
(U.S. dollars in thousands)		2024			2025
b. Accounts payable and accruals – other:
Payroll and related expenses		$	1,343		$	1,629
Provision for vacation			1,811			2,309
Accrued expenses			9,568			9,790
Royalties payable			1,080			799
Income tax payable			3,476			2,950
Payable to customer			2,056			2,029
Property and equipment suppliers			254			369
		$	19,588		$	19,875

Schedule of Supplemental Statements of operations

b. Statements of operations:


(U.S. dollars in thousands)	Year ended December 31,
Research and development expenses:	2023			2024			2025
Employee salaries and related expenses	$	7,758		$	7,068		$	9,696
Subcontractor-related expenses		6,345			2,432			5,631
Materials-related expenses		596			885			1,288
Depreciation		391			428			515
Other expenses		2,003			2,157			2,439
	$	17,093		$	12,970		$	19,569

CONVERTIBLE NOTES (Schedule of Interest Expense Recognized) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
Debt Instrument [Line Items]
Amortization of debt issuance costs and debt discount	$ 0	$ 0	$ 267
2024 Notes
Debt Instrument [Line Items]
Contractual interest expense		1,022	2,534
Amortization of debt issuance costs and debt discount			267
Total		$ 1,022	$ 2,801

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

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+ Details

LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Postemployment Expenses) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT
Total Severance Expenses	$ 1,044	$ 820	$ 801
Severance Expenses in respect of Contribution Plans	1,022	859	798
Gain on amounts funded in respect of employee rights upon retirement	$ 20	$ 18	$ 50

NET EARNINGS (LOSS) PER SHARE

12 Months Ended

Dec. 31, 2025

NET EARNINGS (LOSS) PER SHARE

NET EARNINGS (LOSS) PER SHARE

NOTE 11 – NET EARNINGS (LOSS) PER SHARE

Basic and diluted net earnings (loss) per share attributable to common stockholders were calculated as follows:


		Year Ended December 31,
(In thousands, except share data)		2023	2024			2025
Numerator:
Net income (loss)	$	8,312	$	2,932		$	(6,604)
Add:
Financial expenses of 2024 Notes*		(1,168)		39
Net income (loss) for diluted calculation	$	7,144	$	2,971		$	(6,604)
Denominator:
Weighted average shares of Common Stock outstanding for basic calculation		67,512,527		72,530,698			78,546,234
Weighted average dilutive effect of 2024 Notes		13,335,430		7,667,323
Weighted average dilutive effect of stock options and restricted stock		1,576,059		859,155
Weighted average shares of Common Stock outstanding for diluted calculation		82,424,016		81,057,176			78,546,234

* Financial expenses on 2024 Notes consists of add back of financial expense incurred during the year and inclusion of make-whole interest payments that will be incurred upon conversion.

In the year ended December 31, 2023, the diluted earnings per share do not include 18,254,264 shares of Common Stock underlying outstanding warrants and stock options because the effect would be anti-dilutive. In the year ended December 31, 2024, the diluted earnings per share do not include 16,661,907 shares of Common Stock underlying outstanding stock options, unvested restricted shares and warrants because the effect would be anti-dilutive. In the year ended December 31, 2025, the diluted earnings per share do not include 10,672,506 shares of Common Stock underlying outstanding stock options, unvested restricted shares and warrants because the effect would be anti-dilutive.

COMMERCIALIZATION AGREEMENTS (Details) - USD ($) $ in Millions	Jul. 23, 2018	Oct. 19, 2017	Dec. 31, 2025
Chiesi US Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Non-refundable payment receivable	$ 25.0
Additional amounts payable to cover development costs	20.0
Maximum entitlement of development costs to cover per year	7.5
Additional amount payable for achievement of regulatory and commercial milestones	$ 760.0
Chiesi US Agreement \| Maximum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Payment on net sales percentage	40.00%
Chiesi US Agreement \| Minimum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Payment on net sales percentage	15.00%
Chiesi Ex-US Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Non-refundable payment receivable		$ 25.0
Additional amounts payable to cover development costs		25.0
Maximum entitlement of development costs to cover per year		10.0
Additional amount payable for achievement of regulatory and commercial milestones		$ 320.0	$ 295.0
Chiesi Ex-US Agreement \| Maximum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Payment on net sales percentage		35.00%
Chiesi Ex-US Agreement \| Minimum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Payment on net sales percentage		15.00%

SHARE CAPITAL (Summary of Share Options Outstanding and Exercisable) (Details) - Employee Stock Option	12 Months Ended
	Dec. 31, 2025 $ / shares shares
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Number of options outstanding at end of year	8,274,278
Number of options exercisable	5,464,917
$1.03 - $2.00
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price, lower range \| $ / shares	$ 1.03
Exercise price, upper range \| $ / shares	$ 2
Number of options outstanding at end of year	7,017,970
Weighted average remaining contractual life	7 years 5 months 8 days
Number of options exercisable	4,208,609
Weighted average remaining contractual life	6 years 7 months 20 days
$3.55 - $3.73
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price, lower range \| $ / shares	$ 3.55
Exercise price, upper range \| $ / shares	$ 3.73
Number of options outstanding at end of year	836,308
Weighted average remaining contractual life	3 years 7 months 24 days
Number of options exercisable	836,308
Weighted average remaining contractual life	3 years 7 months 24 days
$4.69 - $5.60
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price, lower range \| $ / shares	$ 4.69
Exercise price, upper range \| $ / shares	$ 5.6
Number of options outstanding at end of year	420,000
Weighted average remaining contractual life	2 years 9 months 3 days
Number of options exercisable	420,000
Weighted average remaining contractual life	2 years 9 months 3 days

COMMITMENTS (Additional Information) (Details) $ in Millions	1 Months Ended		12 Months Ended
	Nov. 30, 2024	Sep. 30, 2024 EUR (€)	Dec. 31, 2025 USD ($)
Chiesi Agreements
Commitments And Contingencies [Line Items]
Extended term of agreement		7 years
Contract amount		€ 2,500,000
Fill/Finish Agreement
Commitments And Contingencies [Line Items]
Initial term of arrangement	10 years
Contracted share of facility cost amount		€ 400,000
Arrangement Other than Collaborative
Commitments And Contingencies [Line Items]
Subcontracting commitment amount \| $			$ 17.7
Minimum \| Royalty Agreement Terms \| Office of the Israeli Innovation Authority
Commitments And Contingencies [Line Items]
Royalties based on sale of products developed from funded projects, percentage			3.00%
Maximum \| Royalty Agreement Terms \| Office of the Israeli Innovation Authority
Commitments And Contingencies [Line Items]
Royalties based on sale of products developed from funded projects, percentage			6.00%
Percentage of Royalties to Grant Received			100.00%

SHARE CAPITAL (Summary of Stock Option Activity) (Details) - Employee Stock Option - $ / shares	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
Number of options
Exercised	(328,481)	0	0
Employees and directors
Number of options
Outstanding at beginning of year	7,402,295
Granted	1,458,990
Expired and forfeited	(258,526)
Exercised	(328,481)
Outstanding at end of year	8,274,278	7,402,295
Exercisable at end of year	5,464,917
Weighted average exercise price
Outstanding at beginning of year	$ 1.98
Granted	1.56
Expired and forfeited	7.53
Exercised	1.13
Outstanding at end of year	1.76	$ 1.98
Exercisable at end of year	$ 1.94

COMMITMENTS (Schedule of Royalty Expenses) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
Royalty Agreement Terms \| Office of the Israeli Innovation Authority
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Royalty expenses to NATI or the IIA	$ 1,557	$ 1,582	$ 1,868

FAIR VALUE MEASUREMENT

12 Months Ended

Dec. 31, 2025

FAIR VALUE MEASUREMENT

FAIR VALUE MEASUREMENT

NOTE 10 - FAIR VALUE MEASUREMENT

The Company discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received from the sale of an asset, or paid to transfer a liability, in an orderly transaction between market participants at the measurement date.

The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:

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 prices 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 is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value.

The fair value of the financial instruments included in the working capital of the Company is usually identical or close to their carrying value.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

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+ Details

Document and Entity Information - USD ($) $ in Millions	12 Months Ended
Document and Entity Information - USD ($) $ in Millions	Dec. 31, 2025	Mar. 01, 2026	Jun. 30, 2025
Document and Entity Information
Document Type	10-K
Document Annual Report	true
Document Period End Date	Dec. 31, 2025
Document Transition Report	false
Securities Act File Number	001-33357
Entity Registrant Name	PROTALIX BIOTHERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	65-0643773
Entity Address, Address Line One	2 University Plaza
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Hackensack
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07601
City Area Code	201
Local Phone Number	696-9345
Title of 12(b) Security	Common stock, $0.001 par value
Trading Symbol	PLX
Security Exchange Name	NYSEAMER
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
ICFR Auditor Attestation Flag	false
Document Financial Statement Error Correction [Flag]	false
Entity Shell Company	false
Entity Public Float			$ 113.1
Entity Common Stock, Shares Outstanding		80,571,642
Entity Central Index Key	0001006281
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2025
Document Fiscal Period Focus	FY
Amendment Flag	false
Auditor Name	Kesselman & Kesselman C.P.A.s
Auditor Firm ID	1309
Auditor Location	Tel Aviv, Israel
Documents Incorporated by Reference	Portions of the registrant’s proxy statement related to its 2026 Annual Stockholders’ Meeting to be filed subsequently are incorporated by reference into Part III of this Annual Report on Form 10-K. Except as expressly incorporated by reference, the registrant’s proxy statement shall not be deemed to be part of this report.

LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Severance Payment Obligations) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT
Deposits with insurance companies in connection with severance payment obligations	$ 26	$ 32	$ 142

SEGMENT INFORMATION

12 Months Ended

Dec. 31, 2025

SEGMENT INFORMATION

SEGMENT INFORMATION

NOTE 13 – SEGMENT INFORMATION

The Company operates in Israel as a single operating segment. The Company’s President and Chief Executive Officer is the chief operating decision maker (the “CODM”). The CODM makes decisions on resource allocation, assesses performance of the business and monitors budget versus actual results on a consolidated basis. For additional information see Note 14.

Segment information:


	Year Ended December 31,
(U.S. dollars in thousands)	2023		2024			2025
Revenues from customers	$	65,494	$	53,399		$	52,744
Less:
Employee salaries and related expenses		24,075		21,780			24,722
Sub-contractors expense		14,008		8,682			12,275
Interest expense		3,180		1,062			-
Interest income		(1,286)		(1,299)			(1,083)
Depreciation		1,191		1,304			1,465
Other segment expenses*		15,760		17,716			20,973
Income (loss) before taxes on income		8,566		4,154			(5,608)
Taxes on income		254		1,222			996
Segment net income (loss)	$	8,312	$	2,932		$	(6,604)

* Other expenses included in net income (loss) includes raw materials, rent and utilities and others.

The following table summarizes the Company’s disaggregation of revenues:


	Year Ended December 31,
(U.S. dollars in thousands)	2023		2024		2025
Gaucher disease:
Pfizer (Ireland)	$	12,522	$	12,617	$	18,227
Fiocruz (Brazil)	$	10,401	$	11,031	$	11,062
Fabry disease:
Chiesi (Italy)	$	17,495	$	29,333	$	22,513
Total revenues from selling goods	$	40,418	$	52,981	$	51,802
Revenues from license and R&D services	$	25,076	$	418	$	942

Long lived assets are located in Israel.

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

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+ Details

RELATED PARTY TRANSACTIONS (Details) - Related Party - Director - USD ($)	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
Related Party Transaction [Line Items]
Compensation (including share based compensation) to the non-executive directors	$ 478,000	$ 555,000	$ 429,000
Consulting fees	$ 0	$ 1,350	$ 35,475

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Additional Information) (Details)	Dec. 31, 2025 USD ($) employee
Maximum
Liability For Employee Rights Upon Retirement [Line Items]
Number of benefit eligible employees \| employee	15
Contribution to Insurance Companies
Liability For Employee Rights Upon Retirement [Line Items]
Contribution in connection with severance liabilities	$ 1,180,000
Contribution to Defined Contribution Plans
Liability For Employee Rights Upon Retirement [Line Items]
Contribution in connection with severance liabilities	$ 1,152,000

Pay vs Performance Disclosure - USD ($) $ in Thousands	12 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (6,604)	$ 2,932	$ 8,312

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

SIGNIFICANT ACCOUNTING POLICIES (Schedule of Useful Life) (Details)	Dec. 31, 2025
Laboratory equipment
Property, Plant and Equipment [Line Items]
Property and equipment, useful life	5 years
Furniture \| Minimum
Property, Plant and Equipment [Line Items]
Property and equipment, useful life	10 years
Furniture \| Maximum
Property, Plant and Equipment [Line Items]
Property and equipment, useful life	15 years
Computer equipment
Property, Plant and Equipment [Line Items]
Property and equipment, useful life	3 years

PROPERTY AND EQUIPMENT (Schedule of Property and Equipment) (Details) - USD ($) $ in Thousands	Dec. 31, 2025	Dec. 31, 2024
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	$ 41,925	$ 40,330
Less - accumulated depreciation and amortization	(37,046)	(35,739)
Property, plant and equipment, net, total	4,879	4,591
Laboratory equipment
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	20,090	19,043
Furniture and computer equipment
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	3,765	3,374
Leasehold improvements
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	$ 18,070	$ 17,913

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

12 Months Ended

Dec. 31, 2025

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

NOTE 14 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

a. Balance sheets:


		December 31,
(U.S. dollars in thousands)		2024			2025
a. Other assets:
Institutions		$	486		$	634
Prepaid expenses			500			394
Sundry			110			101
		$	1,096		$	1,129


		December 31,
(U.S. dollars in thousands)		2024			2025
b. Accounts payable and accruals – other:
Payroll and related expenses		$	1,343		$	1,629
Provision for vacation			1,811			2,309
Accrued expenses			9,568			9,790
Royalties payable			1,080			799
Income tax payable			3,476			2,950
Payable to customer			2,056			2,029
Property and equipment suppliers			254			369
		$	19,588		$	19,875

b. Statements of operations:


(U.S. dollars in thousands)	Year ended December 31,
Research and development expenses:	2023			2024			2025
Employee salaries and related expenses	$	7,758		$	7,068		$	9,696
Subcontractor-related expenses		6,345			2,432			5,631
Materials-related expenses		596			885			1,288
Depreciation		391			428			515
Other expenses		2,003			2,157			2,439
	$	17,093		$	12,970		$	19,569

LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Tables)

12 Months Ended

Dec. 31, 2025

LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT

Schedule of Postemployment Benefit Obligations

For the years ended December 31, 2023, 2024, and 2025, the Company’s deposits with insurance companies in connection with its severance payment obligations were approximately as follows:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Deposits with insurance companies in connection with severance payment obligations		$	142		$	32		$	26


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Total Severance Expenses		$	801		$	820		$	1,044
Severance Expenses in respect of Contribution Plans		$	798		$	859		$	1,022
Gain on amounts funded in respect of employee rights upon retirement		$	50		$	18		$	20

COMMITMENTS

12 Months Ended

Dec. 31, 2025

COMMITMENTS

COMMITMENTS

NOTE 6 - COMMITMENTS

a. Royalty Commitments

The Company is obligated to pay royalties to the National Authority for Technological Innovation (“NATI”) on proceeds from the sale of products developed from research and development activities that were funded, partially, by grants from NATI or its predecessor, the Office of the Israeli Innovation Authority (IIA). At the time the grants were received, successful development of the related projects was not assured.

In the case of failure of a project that was partly financed as described above, the Company is not obligated to pay any such royalties or repay funding received from NATI or the IIA.

Under the terms of the applicable funding arrangements, royalties of 3% to 6% are payable on the sale of products developed from projects funded by NATI or the IIA, which payments shall not exceed, in the aggregate, 100% of the amount of the grant received (dollar linked), plus, commencing upon January 1, 2001, interest at an annual rate based on SOFR. In addition, if the Company receives approval to manufacture products developed with government grants outside the State of Israel, it will, subject to certain exceptions, be required to pay an increased total amount of royalties, depending on the manufacturing volume that is performed outside the State of Israel, and, possibly, an increased royalty rate.


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Royalty expenses to NATI or the IIA		$	1,868		$	1,582		$	1,557

The maximum total royalty amount payable by the Company under these funding arrangements at December 31, 2024 and 2025 (without interest, assuming 100% of the funds are payable) is as follows:


		December 31,
(U.S. dollars in thousands)		2024			2025
Maximum total royalty amount payable (without interest, assuming 100% of the funds are payable)		$	33,900		$	32,391

b. Subcontracting Agreements

The Company has entered into sub-contracting agreements with several clinical providers and consultants in Israel, the United States and certain other countries in connection with its primary product development process. As of December 31, 2025, total commitments under said agreements were approximately $17.7 million.

c. Fill/Finish Agreement

On August 29, 2022, the Company entered into a Fill/Finish Agreement (the “F/F Agreement”) and a Letter Agreement, in each case with Chiesi. The Company agreed to supply Chiesi with drug substance for pegunigalsidase alfa and, following relevant technology and technical information transfer activities, Chiesi has agreed, among other things, to provide the Company with commercial fill/finish services for pegunigalsidase alfa. The F/F Agreement did not change the terms and conditions of the Chiesi Agreements. Subsequently, in November 2024, the Company and Chiesi amended the F/F Agreement to provide that a different Chiesi facility may act as a secondary supplier of such services and that the F/F Agreement shall have an initial term of 10 years, unless terminated earlier in accordance with the terms of the F/F Agreement. Prior to expiration of the initial term, the term may be extended by mutual agreement for an additional period of seven years upon mutual written agreement prior to expiration of the initial term. Under the F/F Agreement, the Company is obligated to pay to Chiesi an amount equal to €2.5 million in connection with the necessary technology transfer, QA tests and capital expenditures. Such amount is to be paid over the term of the F/F agreement based on the actual vials produced by Chiesi thereunder. Under the amendment, the Company and Chiesi agreed to share equally the costs of establishing the new facility as an alternative source for Fill/Finish. The Company’s share of such costs amounting to €400,000 shall be due and payable upon Chiesi’s completion of the manufacture of the requisite validation batches and issuance of the process validation report.

CONVERTIBLE NOTES (Additional Information) (Details) - 2024 Notes - USD ($) $ in Thousands		1 Months Ended
	Aug. 25, 2021	Sep. 30, 2024
Debt Instrument [Line Items]
Interest rate		7.50%
Mature term	3 years
Payment for promissory note		$ 20,420

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

SUBSEQUENT EVENTS (Details) - Subsequent Event $ in Millions	3 Months Ended
	Mar. 18, 2026 USD ($)
Pfizer Agreement
Subsequent Event [Line Items]
Total proceeds from sale of products	$ 1.4
Chiesi Agreements
Subsequent Event [Line Items]
Total proceeds from sale of products	5.5
Change in amount receivable for achievement of regulatory and commercial milestones	25.0
Brazil Agreement with Fiocruz
Subsequent Event [Line Items]
Total proceeds from sale of products	$ 1.9

COMMITMENTS (Maximum Total Royalty Payable) (Details) - USD ($) $ in Thousands	Dec. 31, 2025	Dec. 31, 2024
Maximum \| Royalty Agreement Terms \| Office of the Israeli Innovation Authority
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Maximum total royalty amount payable (without interest, assuming 100% of the funds are payable)	$ 32,391	$ 33,900

TAXES ON INCOME (Schedule of Deferred Tax Assets) (Details) - USD ($) $ in Thousands	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
In respect of:
Research and development expenses	$ 3,717	$ 3,055
Other timing differences	684	452
Net operating loss carry forwards	48,479	50,014
Valuation allowance	(50,364)	(50,665)	$ (51,618)	$ (58,550)
Total net deferred tax assets	$ 2,516	$ 2,856

OPERATING LEASES (Schedule of Operating Leases) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
OPERATING LEASES
Operating lease costs	$ 1,815	$ 1,639	$ 1,471
Cash paid for amounts included in the measurement of lease liabilities	$ 1,804	$ 1,634	$ 1,484
Weighted average remaining lease term (in years)	22 years 7 months 6 days	6 years	6 years 9 months 18 days
Weighted average discount rate	13.40%	12.80%	12.80%

OPERATING LEASES (Schedule of Maturity Analysis of Operating Leases) (Details) $ in Thousands	Dec. 31, 2025 USD ($)
OPERATING LEASES
First year	$ 1,384
Second year	1,192
Third year	1,104
Fourth year	1,058
Fifth year and thereafter	22,445
Total undiscounted cash flows	27,183
Less: imputed interest	18,862
Present value of operating lease liabilities	$ 8,321

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Dec. 31, 2025	Dec. 31, 2024
CURRENT ASSETS:
Cash and cash equivalents	$ 14,680	$ 19,760
Short-term bank deposits	15,593	15,070
Restricted deposit	702	0
Accounts receivable	8,840	2,909
Other assets	1,129	1,096
Inventories	25,729	21,243
Total current assets	66,673	60,078
NON-CURRENT ASSETS:
Funds in respect of employee rights upon retirement	578	462
Property and equipment, net	4,879	4,591
Deferred income tax asset	2,516	2,856
Operating lease right of use assets	7,700	5,430
Total assets	82,346	73,417
Accounts payable and accruals:
Trade	5,259	4,533
Other	19,875	19,588
Operating lease liabilities	1,384	1,500
Total current liabilities	26,518	25,621
LONG TERM LIABILITIES:
Liability for employee rights upon retirement	661	559
Operating lease liabilities	6,937	4,026
Total long term liabilities	7,598	4,585
Total liabilities	34,116	30,206
COMMITMENTS
STOCKHOLDERS' EQUITY
Common Stock, $0.001 par value: Authorized - as of December 31, 2024 and 2025, 185,000,000 shares; issued and outstanding - as of December 31, 2024 and 2025, 75,850,275 and 80,425,981 shares, respectively	80	76
Additional paid-in capital	433,147	421,528
Accumulated deficit	(384,997)	(378,393)
Total stockholders' equity	48,230	43,211
Total liabilities and stockholders' equity	$ 82,346	$ 73,417

SHARE CAPITAL (Summary of Restricted Stock Activity) (Details) - Restricted Stock - $ / shares	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
Weighted average exercise price
Granted	$ 1.66	$ 1.24	$ 1.99
Employees and directors
Number of options
Outstanding at beginning of year	862,816
Granted	564,010
Vested	(687,232)
Non vested at end of year	739,594	862,816
Weighted average exercise price
Outstanding at beginning of year	$ 1.7
Granted	1.66
Vested	1.81
Non vested at end of year	$ 1.58	$ 1.7

TAXES ON INCOME (Valuation Allowance) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
TAXES ON INCOME
Beginning Balance	$ (50,665)	$ (51,618)	$ (58,550)
Additions to valuation allowance			(728)
Reductions to valuation allowance	301	953	7,660
Ending Balance	$ (50,364)	$ (50,665)	$ (51,618)

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
TOTAL REVENUE	$ 52,744	$ 53,399	$ 65,494
COST OF GOODS SOLD	(26,993)	(24,319)	(22,982)
RESEARCH AND DEVELOPMENT EXPENSES	(19,569)	(12,970)	(17,093)
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES	(11,682)	(12,193)	(14,959)
OPERATING INCOME (LOSS)	(5,500)	3,917	10,460
FINANCIAL EXPENSES	(1,191)	(1,062)	(3,180)
FINANCIAL INCOME	1,083	1,299	1,286
FINANCIAL INCOME (EXPENSES), NET	(108)	237	(1,894)
INCOME (LOSS) BEFORE TAXES ON INCOME	(5,608)	4,154	8,566
TAXES ON INCOME	(996)	(1,222)	(254)
NET INCOME (LOSS)	$ (6,604)	$ 2,932	$ 8,312
EARNINGS (LOSS) PER SHARE OF COMMON STOCK - BASIC (in dollars per share)	$ (0.08)	$ 0.04	$ 0.12
EARNINGS (LOSS) PER SHARE OF COMMON STOCK - DILUTED (in dollars per share)	$ (0.08)	$ 0.04	$ 0.09
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING EARNINGS (LOSS) PER SHARE - BASIC (in shares)	78,546,234	72,530,698	67,512,527
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING EARNINGS (LOSS) PER SHARE - DILUTED (in shares)	78,546,234	81,057,176	82,424,016
Goods
TOTAL REVENUE	$ 51,802	$ 52,981	$ 40,418
License and R&D Services
TOTAL REVENUE	$ 942	$ 418	$ 25,076

CONVERTIBLE NOTES

12 Months Ended

Dec. 31, 2025

CONVERTIBLE NOTES

CONVERTIBLE NOTES

NOTE 9 - CONVERTIBLE NOTES

In September 2024, the Company repaid all of the $20.42 million outstanding principal and interest payable under the 2024 Notes. The repayment of the convertible notes at maturity was financed entirely with available cash.

The 2024 Notes were issued pursuant to an indenture entered into between the Company, the guarantors party thereto, The Bank of New York Mellon Trust Company, N.A., as trustee and Wilmington Savings Fund Society, FSB, as collateral agent. Interest on the 2024 Notes was payable semi-annually at a rate of 7.50% per annum. The outstanding 2024 Notes matured three years after the issuance thereof and were guaranteed by the Company’s subsidiaries. The 2024 Notes were secured by perfected liens on all of the assets of the Company and its subsidiaries.

The following table sets forth total interest expense recognized related to the 2024 Notes:


	Year Ended December 31,
(U.S. dollars in thousands)	2023			2024
Contractual interest expense	$	2,534		$	1,022
Amortization of debt issuance costs and debt discount		267			—
Total	$	2,801		$	1,022

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 8A
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480434/815-10-50-8A

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480738/235-10-S50-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
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-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://fasb.org/us-gaap/role/ref/legacyRef
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-URI https://asc.fasb.org/470/tableOfContent

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section 45
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-Publisher FASB
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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Reference 20: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

TAXES ON INCOME (Additional Information) (Details) - USD ($) $ in Thousands	1 Months Ended	12 Months Ended			96 Months Ended
	May 31, 2023	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2025
TAXES ON INCOME
Income tax rate		21.00%	21.00%	21.00%
Change in Valuation allowances	$ (3,100)		$ (953)	$ (6,932)
Deferred tax liability of research and development costs		$ 14,600	11,900	14,400	$ 14,600
Amortization period research and development costs		15 years
Operating Loss Carryforwards		$ 219,800	227,200		219,800
ISRAEL
TAXES ON INCOME
Change in Valuation allowances		(301)
Subsidiaries
TAXES ON INCOME
Operating Loss Carryforwards		199,800	205,000		$ 199,800
Subsidiaries \| ISRAEL
TAXES ON INCOME
Income tax rate					23.00%
Parent Company
TAXES ON INCOME
Operating Loss Carryforwards		$ 20,000	$ 22,200		$ 20,000
Chiesi Agreements
TAXES ON INCOME
Amount of milestone payment received	$ 20,000			$ 20,000

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Accounts Payable and Accruals - Other) (Details) - USD ($) $ in Thousands	Dec. 31, 2025	Dec. 31, 2024
Accounts payable and accruals - other:
Payroll and related expenses	$ 1,629	$ 1,343
Provision for vacation	2,309	1,811
Accrued expenses	9,790	9,568
Royalties payable	799	1,080
Income tax payable	2,950	3,476
Payable to customer	2,029	2,056
Property and equipment suppliers	369	254
Accounts payable and accruals - other	$ 19,875	$ 19,588

OPERATING LEASES

12 Months Ended

Dec. 31, 2025

OPERATING LEASES

OPERATING LEASES

NOTE 7 - OPERATING LEASES

The Company is a party to several lease agreements for its facilities that included varying lease periods and options for extensions. The Company is currently in the second option period for each of the three leases, which periods are not uniform. In September 2025, the Company amended all of the facility leases, collectively, to provide that the third option period for each lease will end on December 31, 2031 and will be associated with a uniform rent increase equal to 7.5%. Thereafter, each lease will extend automatically, on an individual basis, for up to four additional five-year periods unless the Company provides the lessor with six months’ advance notice that it does not intend that any individual option extension become effective. Each option to renew a lease in each of the four

option periods shall include a rent increase equal to 5% of the rent payable for the applicable previous option period. Prior to the amendment, the options to extend the leases were associated with increases of either 7.5% or 10%. The Company expects to exercise the final option in future periods. As of December 31, 2025, the Company provided bank guarantees of approximately $586,000, in the aggregate, to secure the fulfillment of its obligations under the lease agreements. The Company adjusted the operating lease right of use assets by $3.1 million reflecting the amount of remeasurement of the lease liability using a new discount rate at the amendment date.

The Company has entered into several three-year leases for vehicles which are regularly amended as new vehicles are leased.

The following table sets forth data regarding the Company’s operating leases for the years ended December 31, 2023, 2024, and 2025:


	Year Ended December 31,
(U.S. dollars in thousands)	2023			2024			2025
Operating lease costs	$	1,471		$	1,639		$	1,815
Cash paid for amounts included in the measurement of lease liabilities		1,484			1,634			1,804
Weighted average remaining lease term (in years)		6.8			6.0			22.6
Weighted average discount rate		12.8	%		12.8	%		13.4	%

The following table sets forth a maturity analysis of the Company’s operating lease liabilities as of December 31, 2025:


(U.S. dollars in thousands)		December 31, 2025
First year		$	1,384
Second year		$	1,192
Third year		$	1,104
Fourth year		$	1,058
Fifth year and thereafter		$	22,445
Total undiscounted cash flows		$	27,183
Less: imputed interest		$	18,862
Present value of operating lease liabilities		$	8,321

SUBSEQUENT EVENTS

12 Months Ended

Dec. 31, 2025

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

NOTE 16 - SUBSEQUENT EVENTS

Since December 31, 2025, the Company has collected approximately $5.5 million from sales to Chiesi $1.4 million from sales to Pfizer and approximately $1.9 million from sales to Brazil.

The Company became entitled to a regulatory milestone payment of $25.0 million from Chiesi in connection with the EC’s approval of the E4W dosing regimen.

SHARE CAPITAL (Schedule of Stock Option Valuation Assumptions) (Details) - Employee Stock Option - $ / shares	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Weighted average grants date fair value (USD)	$ 1.56	$ 1.1	$ 1.84
Exercise price (in dollars per share)	$ 1.56	$ 1.1	$ 1.84
Risk free rate (in dollars per share)	3.89%	3.55%	4.44%
Volatility (as percentage)	73.64%	79.29%	79.41%
Dividend yield (as percentage)	0.00%	0.00%	0.00%
Expected life (Years)	5 years 9 months	5 years 9 months	5 years 9 months

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (f)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480429/718-10-50-2

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

SEGMENT INFORMATION (Tables)

12 Months Ended

Dec. 31, 2025

SEGMENT INFORMATION

Schedule of Segment Information

Segment information:


	Year Ended December 31,
(U.S. dollars in thousands)	2023		2024			2025
Revenues from customers	$	65,494	$	53,399		$	52,744
Less:
Employee salaries and related expenses		24,075		21,780			24,722
Sub-contractors expense		14,008		8,682			12,275
Interest expense		3,180		1,062			-
Interest income		(1,286)		(1,299)			(1,083)
Depreciation		1,191		1,304			1,465
Other segment expenses*		15,760		17,716			20,973
Income (loss) before taxes on income		8,566		4,154			(5,608)
Taxes on income		254		1,222			996
Segment net income (loss)	$	8,312	$	2,932		$	(6,604)

* Other expenses included in net income (loss) includes raw materials, rent and utilities and others.

Schedule of Disaggregation of Revenues

The following table summarizes the Company’s disaggregation of revenues:


	Year Ended December 31,
(U.S. dollars in thousands)	2023		2024		2025
Gaucher disease:
Pfizer (Ireland)	$	12,522	$	12,617	$	18,227
Fiocruz (Brazil)	$	10,401	$	11,031	$	11,062
Fabry disease:
Chiesi (Italy)	$	17,495	$	29,333	$	22,513
Total revenues from selling goods	$	40,418	$	52,981	$	51,802
Revenues from license and R&D services	$	25,076	$	418	$	942

SHARE CAPITAL (Tables)

12 Months Ended

Dec. 31, 2025

SHARE CAPITAL

Summary of Stock Option Activity

Options granted to employees and directors:


	Year ended December 31, 2025
			Weighted
	Number		average
	of		exercise
	options		price
Outstanding at beginning of year	7,402,295		$	1.98
Changes during the year:
Granted	1,458,990			1.56
Expired and forfeited	(258,526)			7.53
Exercised	(328,481)			1.13
Outstanding at end of year	8,274,278		$	1.76
Exercisable at end of year	5,464,917		$	1.94

Summary of Restricted Stock Activity

Restricted stock granted to employees and directors:


	Year Ended December 31, 2025
			Weighted
	Number of		average
	Restricted		of fair value
	Stock		at grant date
Outstanding at beginning of year	862,816	$	1.70
Changes during the year:
Granted	564,010		1.66
Vested	(687,232)	$	1.81
Non vested at end of year	739,594	$	1.58

Summary of Share Options Outstanding and Exercisable

The following table summarizes information concerning outstanding and exercisable options as of December 31, 2025:


		December 31, 2025
		Options outstanding				Options exercisable
		Number of		Weighted				Weighted
		options		average				average
		outstanding		remaining		Number of		remaining
Exercise		at end of		contractual		options		contractual
prices		year		life		exercisable		life
$1.03-$2.00		7,017,970		7.44		4,208,609		6.64
$3.55-$3.73		836,308		3.65		836,308		3.65
$4.69-$5.60		420,000		2.76		420,000		2.76
		8,274,278				5,464,917

Summary of Weighted Average Grant Date Per Share

The weighted average grants date per share fair value of restricted stock granted in 2023, 2024, and 2025 was as follows:


		Year ended December 31,
		2023			2024			2025
Weighted average grants date per share fair value (USD)		$	1.99		$	1.24		$	1.66

Schedule of Stock Option Valuation Assumptions


	Year Ended December 31,
	2023		2024		2025
Weighted average grants date fair value (USD)	1.84		1.10		1.56
Exercise price (USD)	1.84		1.10		1.56
Risk free rate	4.44	%	3.55	%	3.89	%
Volatility	79.41	%	79.29	%	73.64	%
Dividend yield	0	%	0	%	0	%
Expected life (Years)	5.75		5.75		5.75

Schedule of Stock-Based Compensation Expense in Statement of Operations

The following table illustrates the effect of share-based compensation on the statement of operations:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Cost of goods sold		$	596		$	631		$	431
Research and development expenses			777			589			680
Selling, general, and administrative expenses			2,075			2,033			1,186
		$	3,448		$	3,253		$	2,297

TAXES ON INCOME (Summary of Income Taxes Paid) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024
TAXES ON INCOME
United States (federal)	$ 1,183	$ 385

SHARE CAPITAL (Summary of Weighted Average Grants Date Per Share Fair Value) (Details) - $ / shares	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
Restricted Stock
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Weighted average grants date per share fair value (USD)	$ 1.66	$ 1.24	$ 1.99

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Research and Development Expenses) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
Research And Development Expenses [Line Items]
Depreciation	$ 1,465	$ 1,304	$ 1,191
Research and Development Expense, Total	19,569	12,970	17,093
Research and development expenses
Research And Development Expenses [Line Items]
Employee salaries and related expenses	9,696	7,068	7,758
Sub-contractors expense	5,631	2,432	6,345
Materials-related expenses	1,288	885	596
Depreciation	515	428	391
Other expenses	$ 2,439	$ 2,157	$ 2,003

LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT

12 Months Ended

Dec. 31, 2025

LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT

LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT

NOTE 5 - LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT

The Israeli Subsidiary is required to make a severance payment upon dismissal of an employee or upon termination of employment in certain circumstances. The severance pay liability to the employees (based upon length of service and the latest monthly salary - one month’s salary for each year employed) is recorded on the Company’s balance sheets under “Liability for employee rights upon retirement.” The liability is recorded as if it were payable at each balance sheet date on an undiscounted basis.

The liability is funded in part from the purchase of insurance policies or by the establishment of pension funds with dedicated deposits in the funds. The amounts used to fund these liabilities are included in the Company’s balance sheets under “Funds in respect of employee rights upon retirement.” These policies are the Company’s assets. However, under labor agreements and subject to certain limitations, any policy may be transferred to the ownership of the individual employee for whose benefit the funds were deposited.

For the years ended December 31, 2023, 2024, and 2025, the Company’s deposits with insurance companies in connection with its severance payment obligations were approximately as follows:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Deposits with insurance companies in connection with severance payment obligations		$	142		$	32		$	26

In accordance with the current employment agreements with certain employees, the Company makes regular deposits with certain insurance companies for accounts controlled by each applicable employee in order to secure the employee’s rights upon retirement. The Company is fully relieved from any severance pay liability with respect to each such employee after it makes the payments on behalf of the employee. The liability accrued in respect of these employees and the amounts funded, as of the respective agreement dates, are not reflected in the Company’s balance sheets, as the amounts funded are not under the control and management of the Company and the pension or severance pay risks have been irrevocably transferred to the applicable insurance companies (the “Contribution Plans”).


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Total Severance Expenses		$	801		$	820		$	1,044
Severance Expenses in respect of Contribution Plans		$	798		$	859		$	1,022
Gain on amounts funded in respect of employee rights upon retirement		$	50		$	18		$	20

The Company expects to contribute approximately $1,180,000 in the year ending December 31, 2026 to insurance companies in connection with its severance liabilities, approximately $1,152,000 of which will be contributed to one or more Contribution Plans.

During the five-year period following December 31, 2025, the Company expects that up to 15 employees may retire upon normal retirement age.

- Definition

The entire disclosure for retirement benefits.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2025

SIGNIFICANT ACCOUNTING POLICIES

SIGNIFICANT ACCOUNTING POLICIES

NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES

a. General

Protalix BioTherapeutics, Inc. (collectively with its subsidiary, the “Company”) and its wholly-owned subsidiary, Protalix Ltd., are commercial stage biopharmaceutical companies focused on the discovery, development, production and commercialization of innovative therapeutics for rare diseases with significant unmet needs. ProCellEx^®, the Company’s proprietary plant cell-based protein expression system (“ProCellEx”), represents a new method for developing recombinant proteins in an industrial-scale manner.

To date, the Company has successfully developed two enzyme replacement therapies (ERTs); Elfabrio^® (pegunigalsidase alfa) for the treatment of adult patients with a confirmed diagnosis of Fabry disease and Elelyso^® (taliglucerase alfa) for the treatment of adult patients and children four years of age and older with Gaucher disease.

Elelyso, the Company’s first commercial product, was approved by the U.S. Food and Drug Administration (“FDA”) in 2012 for injection as an ERT for the long-term treatment of adult patients with a confirmed diagnosis of type 1 Gaucher disease. Elelyso is the first plant cell derived recombinant protein to be approved by the FDA for the treatment of Gaucher disease and is now approved in 40 markets including the United States, Brazil, Israel and others. It is not approved in the European Union (EU). In August 2014, the FDA approved Elelyso for injection for children four years of age and older.

Elfabrio, the Company’s second commercial product which was referred to as PRX-102 during its development stage, for the treatment of adult patients with Fabry disease, is our proprietary, plant cell culture expressed enzyme, and a chemically modified stabilized version of, the recombinant α-Galactosidase-A protein, a lysosomal enzyme. It was approved by the European Commission (“EC”) for marketing in the EU and by the FDA for marketing in the United States in May 2023 for adult patients with Fabry disease, and subsequently in more than 10 additional markets. The approvals cover the 1 mg/kg every-two-weeks (E2W) dosage.

On March 5, 2026, the EC ratified the positive opinion issued in January 2026 by the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”). The EC decision approves, in the EU, the 2 mg/kg E4W dosing regimen for Elfabrio in Fabry disease adult patients stable with an ERT treatment.

The Company is committed to leveraging its record of success as the Company progresses with the development of treatments for rare and orphan diseases. In addition, the Company continuously works on the further development and enhancement of its ProCellEx technology. Accordingly, the Company is turning its focus to new, early-stage product candidates that treat indications for which there are high unmet needs in terms of efficacy and safety, including renal diseases. The Company believe that its treatments of interest will address both genetic and non-genetic diseases. The Company intends to use its ProCellEx platform and PEGylation capabilities, as well as other modalities such as small molecules and antibodies, to take advantage of highly innovative opportunities. The Company is also exploring novel platform technologies. Consistent with its strategy, the Company continuously evaluates potential strategic marketing partnerships as well as collaboration programs with biotechnology and pharmaceutical companies and academic research institutions. Except with respect to Elfabrio and Elelyso, the Company holds the worldwide commercialization rights to its other proprietary development candidates.

The Company’s product pipeline currently includes, among other candidates:

PRX-115, the Company’s plant cell-expressed recombinant PEGylated uricase (urate oxidase) – a chemically modified enzyme to treat uncontrolled gout; and

PRX-119, the Company’s plant cell-expressed PEGylated recombinant human DNase I product candidate for long and customized systemic circulation in the bloodstream for NETs-related diseases.

Obtaining marketing approval with respect to any product candidate in any country is dependent on the Company’s ability to implement the necessary regulatory steps required to obtain such approvals, and demonstrate the safety and efficacy of its product candidates. The Company cannot reasonably predict the outcome of these activities.

Since its approval by the FDA, Elelyso has been marketed by Pfizer Inc. (“Pfizer”) originally pursuant to an exclusive license and supply agreement between Protalix Ltd. and Pfizer which was amended and restated in October 2015 (the “Amended Pfizer Agreement”). Pursuant to the Amended Pfizer Agreement, the Company sold to Pfizer its share in the collaboration worldwide except for Brazil. Pfizer is entitled to all of the revenues, and is responsible for 100% of expenses globally for Elelyso, excluding Brazil where the Company is responsible for all expenses and retains all revenues.

On June 18, 2013, the Company entered into a Supply and Technology Transfer Agreement (the “Brazil Agreement”) with Fundação Oswaldo Cruz (“Fiocruz”), an arm of the Brazilian Ministry of Health (the “Brazilian MoH”) for BioManguinhos alfataliglicerase. Fiocruz’s purchases of BioManguinhos alfataliglicerase to date have been significantly below certain agreed-upon purchase milestones and, accordingly, the Company has the right to terminate the Brazil Agreement. Notwithstanding the termination right, the Company is, at this time, continuing to supply BioManguinhos alfataliglicerase to Fiocruz and patients continue to be treated with BioManguinhos alfataliglicerase in Brazil.

The Company, through its wholly-owned subsidiary, Protalix Ltd., has licensed the rights to commercialize Elelyso worldwide (other than Brazil) to Pfizer, and in Brazil to Fiocruz. Elelyso is marketed as BioManguinhos alfataliglicerase in Brazil.

The Company has partnered with Chiesi Farmaceutici S.p.A. (“Chiesi”) for the development and commercialization of Elfabrio through two exclusive global licensing and supply agreements. On October 19, 2017, Protalix Ltd. entered into an Exclusive License and Supply Agreement with Chiesi (the “Chiesi Ex-US Agreement”) pursuant to which Chiesi was granted an exclusive license for all markets outside of the United States to commercialize Elfabrio. On July 23, 2018, Protalix Ltd. entered into an Exclusive License and Supply Agreement with Chiesi (the “Chiesi US Agreement”), with respect to the commercialization of Elfabrio in the United States.

Because the Company’s operations are conducted in the State of Israel, the business and operations may be directly affected by military, economic, political and geopolitical conditions in Israel. Since October 2023, Israel has suffered from missile and other similar attacks and has been engaged in military activity on a number of fronts, including with the Hamas in the Gaza Strip, Hezbollah in Lebanon, Iran, the Houthis terrorist group that controls parts of Yemen, and others, and both civilian and military targets in Israel have been attacked. Such clashes may escalate in the future into a greater regional conflict. In October 2025, Israel and Hamas entered into a ceasefire agreement intended to permanently end the war between Israel and Hamas. However, there are no assurances regarding continued compliance with such agreement. While the conflict created and continues to create heightened security concerns, disruptions to business operations, and economic instability within Israel, the ceasefire may contribute to improved regional stability. The security situation remains fluid and any renewed military actions, restrictions, or government-imposed measures could have a material adverse effect on the Company’s business, results of operations, and financial condition. On February 28, 2026, the US and Israeli militaries commenced air-based campaigns in Iran which have resulted in a larger regional event and has resulted in increased missile and similar attacks on civilian and military targets in Israel and in other countries in the region. This has resulted in global security concerns that may result in a greater or lasting regional conflict. It is currently

not possible to predict the duration or severity of the ongoing conflict or its effects on the Company’s business, results of operations, and financial conditions.

The Company expects to continue to incur significant expenditures in the near future due to research and developments efforts with respect to its product candidates. The Company believes that its cash and cash equivalents and short-term bank deposits are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued.

b. Basis of presentation

The Company’s financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”).

c. Use of estimates in the preparation of financial statements

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates.

d. Functional currency

The dollar is the currency of the primary economic environment in which the operations of the Company and its Subsidiaries are conducted. The Company’s revenues are derived in dollars. Most of the Company’s expenses and capital expenditures are incurred in dollars, and the major source of the Company’s financing has been provided in dollars.

Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions and other items (stated below) reflected in the statements of operations, the following exchange rates are used: (i) for transactions – exchange rates at the transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation and amortization, etc.) – historical exchange rates. Currency translation gains and losses are recorded as financial income or expenses, as appropriate.

e. Cash equivalents

The Company considers all short-term, highly liquid investments, which include short-term bank deposits with original maturities of three months or less from the date of purchase, that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash, to be cash equivalents.

f. Short-term bank deposits

Bank deposits with original maturity dates of more than three months but less than one year are included in short-term deposits. Such short-term deposits bore interest at an average annual rate of approximately 5.05%-5.75% for the years ended December 31, 2025 and 2024.

g. Restricted deposit

Restricted deposit is deposited in an interested-bearing saving account which is used as a security for the Company's potential hedging activities.

h. Accounts Receivables

Accounts receivable are recorded net of an allowance for credit losses. The Company maintains the allowance for estimated losses resulting from the inability of the Company’s customers to make required payments. The allowance represents the current estimate of lifetime expected credit losses over the remaining duration of existing accounts receivable considering historical collection experience, current market conditions and supportable forecasts when appropriate. The estimate is a result of the Company’s ongoing evaluation of collectability, customer creditworthiness, historical levels of credit losses and future expectations. As of December 31, 2025 and 2024, the allowance was negligible.

No write-off activity and recoveries for the periods presented were recognized.

i. Inventories

Inventories are valued at the lower of cost or net realizable value. Cost of raw and packaging materials and purchased products is determined using the “moving average” basis.

Cost of finished products is determined as follows: the value of the raw and packaging materials component is determined primarily using the “moving average” basis; the value of the labor and overhead component is determined on an average basis over the production period.

Inventory is written down for estimated obsolescence based upon management assumptions about future demand and market conditions.

j. Property and equipment

1. Property and equipment are stated at cost, net of accumulated depreciation and amortization.

2. The Company’s assets are depreciated by the straight-line method on the basis of their estimated useful lives as follows:


		Years
Laboratory equipment		5
Furniture		10-15
Computer equipment		3

Leasehold improvements are amortized by the straight-line method over the shorter of (i) the expected lease term and (ii) the estimated useful life of the improvements.

k. Impairment of long-lived assets

The Company tests long-lived assets for impairment if an indication of impairment exists. If the sum of expected undiscounted future cash flows of definite life assets is less than the carrying amount of such assets, the Company recognizes an impairment loss in the amount by which the carrying amount of the assets exceeds their fair value.

l. Income taxes

1. Deferred income taxes

Deferred taxes are determined utilizing the assets and liabilities method based on the estimated future tax effects of the differences between the financial accounting and tax bases of assets and liabilities under the applicable tax laws. Deferred tax balances are computed using the tax rates expected to be in effect when

those differences reverse. A valuation allowance in respect of deferred tax assets is provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

2. Uncertainty in income taxes

Tax benefits recognized in the financial statements are those that the Company’s management deems at least more likely than not to be sustained, based on technical merits. The amount of benefits recorded for these tax benefits is measured as the largest benefit the Company’s management deems more likely than not to be sustained. Liabilities relating to uncertain tax positions are classified as current in the consolidated balance sheets to the extent the Company anticipates making payments within one year.

m. Revenue Recognition

Under Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers, a contract with a customer exists only when: the parties to the contract have approved it and are committed to perform their respective obligations, the Company can identify each party’s rights regarding the distinct goods or services to be transferred (“performance obligations”), the Company can determine the transaction price for the goods or services to be transferred, the contract has commercial substance and it is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer.

Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for performance obligations upon transfer of control to the customer.

Revenue is recognized net of any taxes collected from customers which are subsequently remitted to governmental entities (e.g., indirect taxes).

1. Revenues from selling products

The Company recognizes revenues from selling goods at a point in time when control over the product is transferred to customers (upon delivery).

The consideration promised in a contract with a Company’s customer is based on either fixed amounts or variable amounts. Variable amounts are based on the average net selling price of the drug product in the applicable territory. The Company estimates the variable consideration and recognizes revenue only to the extent the variable consideration is probable and that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Prior to recognizing revenue from variable consideration, the Company uses significant judgment to determine the probability of significant reversal of such revenue. The Company’s payment terms are generally 45 days or less.

2. Revenues from license and R&D services

The Company has identified two performance obligations in each of the Chiesi Ex-US Agreement and the Chiesi US Agreement (collectively, the “Chiesi Agreements”) as follows: (1) the license and research and development services and (2) the contingent performance obligation regarding future manufacturing.

The Company determined that the license together with the research and development services should be combined into a single performance obligation since Chiesi cannot benefit from the license without the research and development services. The research and development services are highly specialized and are dependent on the supply of the drug.

The future manufacturing was contingent on regulatory approvals of the drug and the Company deems these services to be separately identifiable from other performance obligations in the contract. Manufacturing services post-regulatory approval are not interdependent or interrelated with the license and research and development services. Following the regulatory approvals for Elfabrio received in May 2023, the Company started recognizing revenue from manufacturing. See also revenue from selling products above.

The transaction price was comprised of fixed consideration and variable consideration (capped research and development reimbursements). Under ASC 606, the consideration to which the Company would be entitled upon the achievement of contractual milestones, which are contingent upon the occurrence of future events, are a form of variable consideration. The Company estimates variable consideration using the most likely amount method. Amounts included in the transaction price are recognized only when it is probable that a significant reversal of cumulative revenues will not occur. Prior to recognizing revenue from variable consideration, the Company uses significant judgment to determine the probability of significant reversal of such revenue. Following the approval of Elfabrio by the FDA in 2023, the Company received a milestone payment equal to $20.0 million which was recognized as revenue from license and R&D services.

Since the customer benefits from the research and development services as the entity performs the service, revenue from granting the license and the research and development services is recognized over time using the cost-to-cost method since the customer benefits from the research and development services as the entity performs the service.

Revenue from additional research and development services ordered by Chiesi, is recognized over time using the cost-to-cost method.

n. Research and development costs

Research and development costs are expensed as incurred and consist primarily of personnel, subcontractors and consultants (mainly in connection with clinical trials), facilities, equipment and supplies for research and development activities. In connection with purchases of assets, amounts assigned to intangible assets to be used in a particular research and development project that have no alternative future use are charged to research and development costs at the purchase date. Costs incurred for performing research and development services are included in research and development expenses.

o. Concentration of credit risks and trade receivable

Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash, bank deposits, restricted deposit and account receivables - trade. The Company’s deposits are instruments with highly rated financial institutions, mainly in Israeli banks, and, as a matter of policy, limits the amounts of credit exposure to any one financial institution. The Company has not experienced any credit losses in these accounts and does not believe it is exposed to any significant credit risk on these instruments. The Company’s trade receivables represent amounts to be received from its customers. The Company does not require its customers to post collateral with respect to receivables.

As of December 31, 2024 and 2025, the accounts receivables trade balance was composed of the following:


		December 31,
(U.S. dollars in thousands)		2024			2025
Chiesi		$	-		$	5,473
Pfizer			1,192			1,426
Fiocruz			1,717			1,941
		$	2,909		$	8,840

p. Share-based compensation

The Company accounts for share-based payment awards classified as equity awards, including stock-based option awards and restricted stock, using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period.

The Company calculates the fair value of stock-based option awards on the date of grant using the Black-Scholes option pricing model. This option pricing model requires estimates as to the option’s expected term and the price volatility of the underlying stock.

The Company measures compensation expense for restricted stock based on the market value of the underlying stock at the date of grant.

The Company elected to recognize compensation cost for awards to employees with only service conditions that have a graded vesting schedule using the accelerated method.

The Company elects to account for forfeitures as they occur.

q. Net earnings (loss) per share

Basic earnings (loss) per share is calculated by dividing the net income (loss) by the weighted average number of shares of common stock, par value $0.001 per share (the “Common Stock”), outstanding during each period.

Diluted earnings per share is calculated by dividing (a) the net income that includes addition of financial expenses related to convertible notes by (b) the weighted-average number of shares of Common Stock outstanding during each period increased to include the number of additional shares of Common Stock that would have been outstanding if the potentially dilutive shares had been issued.

In computing diluted earnings per share, basic earnings per share are adjusted to take into account the potential dilution that could occur upon: (i) the exercise of options and non-vested restricted stock granted under employee stock compensation plans using the treasury stock method; (ii) the exercise of warrants using the treasury stock method; and (iii) the conversion of convertible notes using the “if-converted” method.

r. Convertible notes

In September 2024, the Company repaid in full all of the outstanding principal and interest payable under its 7.50% Senior Secured Convertible Promissory Notes due 2024 (the “2024 Notes”). The repayment of the convertible notes at maturity was financed entirely with available cash.

Prior to January 1, 2024, the Company accounted for its outstanding convertible notes using the guidance set forth in the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 815 which required that the Company determine whether the embedded conversion option must

be separated from the other features of the applicable note instrument and accounted for separately. ASC 470-20 regarding debt with conversion and other options requires the issuer of a convertible debt instrument that may be settled in cash upon conversion to separately account for the liability (debt) and equity (conversion option) components of the instrument in a manner that reflects the issuer’s nonconvertible debt borrowing rate. The Company’s outstanding 2024 Notes were accounted for as a liability (debt) and equity component (conversion option) as the convertible notes may be settled wholly or partly in cash, at the option of the Company, when converted.

Starting from January 1, 2024, the convertible debt instruments were accounted for as a single liability measured at amortized cost.

s. Leases

Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company determines if an arrangement is a lease at inception. Lease classification is governed by five criteria in ASC 842-10-25-2. If any of these five criteria is met, the Company classifies the lease as a finance lease. Otherwise, the Company classifies the lease as an operating lease. The Company does not have any finance leases.

Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the consolidated balance sheets.

ROU assets represent the Company’s 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. Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date to determine the present value of the lease payments.

The Company elected the short-term lease recognition exemption for all leases with a term shorter than 12 months. This means, for those leases, the Company does not recognize ROU assets or lease liabilities.

Lease terms include options to extend or terminate the lease when it is reasonably certain that the Company will either exercise or not exercise the option to renew or terminate the lease. The Company recognizes lease expenses over the lease term on a straight-line basis.

The Company applies the portfolio approach to account for the operating lease ROU assets and liabilities for certain car leases and incremental borrowing rates.

t. New accounting pronouncements

Recently adopted accounting pronouncements

In December 2023, the FASB issued Accounting Standards Update (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 through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. 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 adopted this standard on a prospective basis. See Note 12.

Recently issued accounting pronouncements, not yet adopted

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. 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.

In December 2025, the FASB issued ASU 2025-10 “Government Grants (Topic 832)” to establish authoritative guidance on the accounting for government grants received by business entities. This update is effective beginning with the Company’s 2029 fiscal year annual reporting period, with early adoption permitted. The Company is currently evaluating the impact that the adoption of this standard will have on its consolidated financial statements.

In December 2025, the FASB issued ASU 2025-11 to amend the guidance in “Interim Reporting” (Topic 270). The update provides clarifications intended to improve the consistency and usability of interim disclosure requirements, including a comprehensive listing of required interim disclosures and a new disclosure principle for reporting material events occurring after the most recent annual period. The amendments do not change the underlying objectives of interim reporting but are designed to enhance clarity in application. The ASU is effective for fiscal years beginning after December 15, 2027, and interim periods within those fiscal years. The Company is currently evaluating the effects that ASU 2025-11 will have on its interim consolidated financial statements and related disclosures.

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)	$ (6,604)	$ 2,932	$ 8,312
Adjustments required to reconcile net income (loss) to net cash provided by (used in) operating activities:
Share-based compensation	2,297	3,253	3,448
Depreciation	1,465	1,304	1,191
Financial (income) expenses, net	606	310	(446)
Changes in accrued liability for employee rights upon retirement	22	(151)	3
Changes in deferred income tax asset	340	236	(3,092)
Gain on amounts funded in respect of employee rights upon retirement	(20)	(18)	(50)
Loss (gain) on sale of fixed assets	0	(3)	9
Gain on conversions of convertible notes	0	0	(421)
Amortization of debt issuance costs and debt discount	0	0	267
Changes in operating assets and liabilities:
Decrease in contracts liability	0	0	(13,178)
Decrease (increase) in accounts receivable-trade and other assets	(5,890)	2,317	(428)
Changes in operating lease right of use assets, net	(15)	(4)	13
Increase in inventories	(4,486)	(2,198)	(2,241)
Increase in accounts payable and accruals	292	696	5,295
Net cash provided by (used in) operating activities	(11,993)	8,674	(1,318)
CASH FLOWS FROM INVESTING ACTIVITIES:
Investment in bank deposits	(5,000)	(15,000)	(20,420)
Short-term deposit withdrawal	5,000	20,420	5,000
Purchase of property and equipment	(1,638)	(1,282)	(1,149)
Proceeds from sale of property and equipment	0	3	0
Amounts paid (funded) in respect of employee rights upon retirement, net	(26)	80	(142)
Increase in restricted deposit	(702)	0	0
Net cash provided by (used in) investing activities	(2,366)	4,221	(16,711)
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment for convertible notes redemption	0	(20,420)	0
Proceeds from issuance of common stock under the Sales Agreement, net	6,812	3,626	23,954
Exercise of warrants and options	2,514	0	712
Net cash provided by (used in) financing activities	9,326	(16,794)	24,666
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS	(47)	25	(114)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	(5,080)	(3,874)	6,523
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR	19,760	23,634	17,111
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF YEAR	14,680	19,760	23,634
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
Purchase of property and equipment	369	254	614
Operating lease right of use assets obtained in exchange for new operating lease liabilities	3,185	376	1,567
Convertible notes conversions	0		7,783
Partial settlement of liability for employee rights upon retirement through transfer of the related funds	0		882
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS
Tax paid	1,183	385
Interest paid	0	1,532	2,742
Interest received	$ 651	$ 1,487	$ 355

TAXES ON INCOME (Summary of Income (loss) Before Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
TAXES ON INCOME
Domestic	$ (4,579)	$ (4,548)	$ (7,061)
Foreign	(1,029)	8,702	15,627
INCOME (LOSS) BEFORE TAXES ON INCOME	$ (5,608)	$ 4,154	$ 8,566

- Definition

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

+ References

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Reference 11: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 14: http://www.xbrl.org/2003/role/exampleRef
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+ Details

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Dec. 31, 2025	Dec. 31, 2024
CONSOLIDATED BALANCE SHEETS
Common Stock, Par or Stated Value Per Share (in dollars per share)	$ 0.001	$ 0.001
Common Stock, Shares Authorized	185,000,000	185,000,000
Common Stock, issued	80,425,981	75,850,275
Common Stock, outstanding	80,425,981	75,850,275

SIGNIFICANT ACCOUNTING POLICIES (Tables)

12 Months Ended

Dec. 31, 2025

SIGNIFICANT ACCOUNTING POLICIES

Schedule of Useful Life

The Company’s assets are depreciated by the straight-line method on the basis of their estimated useful lives as follows:


		Years
Laboratory equipment		5
Furniture		10-15
Computer equipment		3

Schedule of Accounts Receivables

As of December 31, 2024 and 2025, the accounts receivables trade balance was composed of the following:


		December 31,
(U.S. dollars in thousands)		2024			2025
Chiesi		$	-		$	5,473
Pfizer			1,192			1,426
Fiocruz			1,717			1,941
		$	2,909		$	8,840

Cybersecurity Risk Management and Strategy Disclosure	12 Months Ended
Cybersecurity Risk Management and Strategy Disclosure	Dec. 31, 2025
Cybersecurity Risk Management, Strategy, and Governance [Line Items]
Cybersecurity Risk Management Processes for Assessing, Identifying, and Managing Threats [Text Block]	Our operations include the creation, collection and maintenance of sensitive information, including proprietary and confidential business information, intellectual property, third-party information and employee information. To protect this information, we use external and internal services to managed detection and response services to monitor our network infrastructure and associated endpoints for possible cybersecurity threats on a constant basis. In addition, we use multi-factor authentication (MFA) for external use, perform penetration testing and engage third parties to assess the effectiveness of our cybersecurity practices. We conduct a thorough risk assessment by identifying critical assets, recognizing potential threats and vulnerabilities, and implement strategies to mitigate these risks and their possible impacts. We establish incident response plans and provide cybersecurity and phishing training to our employees and monitor their activity to ensure adherence to our security protocols. A material cyber-attack on our systems, or any other third-party partners or vendors and their key operating systems, may interrupt our ability to operate our business, damage our reputation, or result in monetary damages. We have implemented a Data Protection Policy, or the DPP, in order to establish the high-level direction for properly managing the use, privacy, security, retention, and disposal of our information, data and assets, and to manage identified material cybersecurity risks. The DPP was prepared using relevant guidance issued and technology standards that are used across various industries. It applies to all entities who are using our equipment and resources, including but not limited to, employees and temporary workers. Our Senior Director, Information Technology, is a certified information security officer (CISO). He is primarily responsible for implementing and overseeing the DPP and identifying, measuring, monitoring, and reporting on key enterprise-wide risks, including cybersecurity risks. Our DPP includes an incident response process that includes reporting thresholds and follows standardized identification and authentication practices. If an incident is identified, it is documented by our Senior Director, Information Technology, who is required to report the incident to management. We work with third-party service providers that monitor our systems on a continuous, round-the-clock basis, and assist us to identify, assess and manage cybersecurity risks, including professional SEIM SOC and other services firms, threat intelligence service providers, cybersecurity consultants, cybersecurity software providers, managed cybersecurity service providers, and penetration testing. No risks from cybersecurity threats have occurred that have materially affected or are reasonably likely to materially affect our business, results of operations or financial condition.
Cybersecurity Risk Management Processes Integrated [Flag]	true
Cybersecurity Risk Management Processes Integrated [Text Block]	Our operations include the creation, collection and maintenance of sensitive information, including proprietary and confidential business information, intellectual property, third-party information and employee information. To protect this information, we use external and internal services to managed detection and response services to monitor our network infrastructure and associated endpoints for possible cybersecurity threats on a constant basis. In addition, we use multi-factor authentication (MFA) for external use, perform penetration testing and engage third parties to assess the effectiveness of our cybersecurity practices. We conduct a thorough risk assessment by identifying critical assets, recognizing potential threats and vulnerabilities, and implement strategies to mitigate these risks and their possible impacts. We establish incident response plans and provide cybersecurity and phishing training to our employees and monitor their activity to ensure adherence to our security protocols. A material cyber-attack on our systems, or any other third-party partners or vendors and their key operating systems, may interrupt our ability to operate our business, damage our reputation, or result in monetary damages. We have implemented a Data Protection Policy, or the DPP, in order to establish the high-level direction for properly managing the use, privacy, security, retention, and disposal of our information, data and assets, and to manage identified material cybersecurity risks. The DPP was prepared using relevant guidance issued and technology standards that are used across various industries. It applies to all entities who are using our equipment and resources, including but not limited to, employees and temporary workers. Our Senior Director, Information Technology, is a certified information security officer (CISO). He is primarily responsible for implementing and overseeing the DPP and identifying, measuring, monitoring, and reporting on key enterprise-wide risks, including cybersecurity risks. Our DPP includes an incident response process that includes reporting thresholds and follows standardized identification and authentication practices. If an incident is identified, it is documented by our Senior Director, Information Technology, who is required to report the incident to management. We work with third-party service providers that monitor our systems on a continuous, round-the-clock basis, and assist us to identify, assess and manage cybersecurity risks, including professional SEIM SOC and other services firms, threat intelligence service providers, cybersecurity consultants, cybersecurity software providers, managed cybersecurity service providers, and penetration testing.
Cybersecurity Risk Management Third Party Engaged [Flag]	true
Cybersecurity Risk Third Party Oversight and Identification Processes [Flag]	true
Cybersecurity Risk Materially Affected or Reasonably Likely to Materially Affect Registrant [Flag]	false
Cybersecurity Risk Board of Directors Oversight [Text Block]	Our Board of Directors addresses our cybersecurity risk management as part of its general oversight function. Our Chief Financial Officer and IT consultant provide periodic briefings to the Board of Directors regarding our cybersecurity risks and activities, including any recent cybersecurity incidents and related responses, if any, cybersecurity systems testing, activities of third parties, and the like.
Cybersecurity Risk Board Committee or Subcommittee Responsible for Oversight [Text Block]	Board of Directors
Cybersecurity Risk Process for Informing Board Committee or Subcommittee Responsible for Oversight [Text Block]	Our Board of Directors addresses our cybersecurity risk management as part of its general oversight function. Our Chief Financial Officer and IT consultant provide periodic briefings to the Board of Directors regarding our cybersecurity risks and activities, including any recent cybersecurity incidents and related responses, if any, cybersecurity systems testing, activities of third parties, and the like.
Cybersecurity Risk Role of Management [Text Block]	Our cybersecurity risk assessment and management processes are implemented and maintained by certain members of our management, including our Senior Director, Information Technology, who reports to our Sr. Vice President, Operations. Management is also responsible for hiring appropriate personnel, integrating cybersecurity considerations into our overall risk management strategy, and for communicating key priorities to employees, as well as for approving budgets, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports. Our incident response process involves management, who participates in our disclosure controls and procedures. Our incident response process is designed to escalate certain cybersecurity incidents and vulnerabilities to members of management depending on the circumstances, including work with our incident response team to help the company mitigate and remediate cybersecurity incidents of which they are notified. In addition, our incident response processes include reporting to our Board of Directors for certain cybersecurity incidents. Management is involved with our efforts to prevent, detect, and mitigate cybersecurity incidents by overseeing preparation of cybersecurity policies and procedures, testing incident response plans and engaging vendors to conduct penetration tests. Management participates in cybersecurity incident response efforts by being a member of the incident response team and helping direct our response to cybersecurity incidents.
Cybersecurity Risk Management Positions or Committees Responsible [Flag]	true
Cybersecurity Risk Management Positions or Committees Responsible [Text Block]	Senior Director, Information Technology
Cybersecurity Risk Management Expertise of Management Responsible [Text Block]	Our Senior Director, Information Technology, is a certified information security officer (CISO). He is primarily responsible for implementing and overseeing the DPP and identifying, measuring, monitoring, and reporting on key enterprise-wide risks, including cybersecurity risks.
Cybersecurity Risk Process for Informing Management or Committees Responsible [Text Block]	Management is involved with our efforts to prevent, detect, and mitigate cybersecurity incidents by overseeing preparation of cybersecurity policies and procedures, testing incident response plans and engaging vendors to conduct penetration tests. Management participates in cybersecurity incident response efforts by being a member of the incident response team and helping direct our response to cybersecurity incidents.
Cybersecurity Risk Management Positions or Committees Responsible Report to Board [Flag]	true

TAXES ON INCOME

12 Months Ended

Dec. 31, 2025

TAXES ON INCOME

TAXES ON INCOME

NOTE 12 - TAXES ON INCOME

The Company

Protalix BioTherapeutics, Inc. is taxed according to U.S. tax laws. The Company’s income is taxed in the United States at a rate of up to 21%.

The U.S. Tax Cuts and Jobs Act, which was enacted into law in December 2017 (the “TCJA”) represents fundamental and dramatic modifications to the U.S. tax system. It contains several key tax provisions that impacted the Company including the reduction of the maximum U.S. federal corporate income tax rate from 35% to 21%, effective January 1, 2018. Other significant changes under the TCJA includes, among others, a one-time repatriation tax on accumulated foreign earnings, a limitation of NOL deduction to 80% of taxable income, and indefinite carryover of post-2017 NOLs. The TCJA also repealed the corporate alternative minimum tax for tax years beginning after December 31, 2017. Losses generated prior to January 1, 2018 will still be subject to the 20-year carryforward limitation and the alternative minimum tax. Other impacts due to the TCJA included the repeal of the domestic manufacturing deduction, modification of taxation of controlled foreign corporations, a base erosion anti-abuse tax, modification of interest expense limitation rules, modification of limitation on deductibility of excessive executive compensation, and taxation of global intangible low-taxed income.

Modification of interest expense limitation rules under the TCJA provides generally that for taxable years 2019-2022 interest expense deduction shall be limited to 50% of the EBITDA and for taxable years 2022 onwards to 30% of EBIT. Disallowed interest deduction may be carried forward indefinitely. The Company believes that any potential impact (if applicable) of this limitation will be offset by utilization of available NOLs.

On July 4, 2025, tax reform legislation was enacted in the United States through the passage of H.R.1, The One Big Beautiful Act, which includes significant corporate tax changes, including a restoration of the current deductibility of domestic research expenditures beginning in 2025 under IRC Section 174A, with transition options for previously capitalized amounts. Foreign research expenditures continue to require capitalization subject to the mandatory 15-year amortization period under existing IRC Section 174. The Company implemented the transition options permitted.

Section 174 which requires taxpayers to capitalize and amortize research and development expenses for tax years beginning after December 31, 2021, resulted in the capitalization of research and development costs of approximately $14.4 million, $11.9 million and $14.6 million in 2023, 2024, and 2025, respectively. The Company will amortize these costs for tax purposes over 15 years for research and development performed outside the United States.

The Company believes that all future profits of its Subsidiary will be indefinitely reinvested or that there is no expectation to distribute any taxable dividends from the Subsidiary. The determination of the amount of the unrecognized deferred tax liability related to the undistributed earnings is estimated as an immaterial amount.

b. Protalix Ltd.

The Company as a “foreign-investment company” measures its results for tax purposes in dollar based on Income Tax Regulations (Bookkeeping Principles of Foreign Invested Companies and of Certain Partnerships and the Determination of Their Taxable Income), 1986. The Israeli Subsidiary is taxed according to Israeli tax laws:

Tax rates

The income of the Israeli Subsidiary, other than income from “Approved Enterprises,” is taxed in Israel at the regular corporate tax rates.

The corporate tax rate was 23% for 2018 and thereafter.

Capital gain on a sale of assets is subject to capital gain tax according to the corporate tax rate in effect in the year during which the assets are sold.

The Law for the Encouragement of Capital Investments, 1959 (the “Encouragement of Capital Investments Law”)

Under the Encouragement of Capital Investments Law, including Amendment No. 60 to the Encouragement of Capital Investments Law as published in April 2005, by virtue of the “Approved Enterprise” status the Israeli Subsidiary is entitled to various tax benefits as follows:

a. Reduced tax rates

Income derived from the Approved Enterprise during a 10-year period commencing upon the year in which the enterprise first realizes taxable income is tax exempt, provided that the maximum period to which it is restricted by the Encouragement of Capital Investments Law has not elapsed.

The Israeli Subsidiary has an “Approved Enterprise” plan since 2004. The period of benefits in respect of the main enterprise of the Company has not yet commenced.

If the Israeli Subsidiary subsequently pays a dividend out of income derived from the “Approved Enterprise” during the tax exemption period, it will be subject to tax on the gross amount distributed (including the company tax on these amounts), at the rate which would have been applicable if such income not been exempted.

b. Conditions for entitlement to the benefits

The Israeli Subsidiary’s entitlement to the benefits described above is subject to its fulfillment of conditions stipulated by the law, rules and regulations published thereunder, and the instruments of approval for the specific investment in an approved enterprise. Failure by the Israeli Subsidiary to comply with these conditions may result in the cancellation of the benefits, in whole or in part, and the Israeli Subsidiary may be required to refund the amount of the benefits with interest. The Israeli Subsidiary received a final implementation approval with respect to its “Approved Enterprise” from the Investment Center.

c. Amendment of the Law for the Encouragement of Capital Investments, 1959

In recent years, several amendments have been made to the Encouragement of Capital Investments Law which have enabled new alternative benefit tracks, subject to certain conditions.

The Encouragement of Capital Investments Law was amended as part of the Economic Policy Law for the years 2011-2012 (amendment 68 to the Encouragement of Capital Investments Law), which was passed by the Israeli Knesset on December 29, 2010. The amendment sets alternative benefit tracks to those currently in effect under the provisions of the Encouragement of Capital Investments Law. On December 29, 2016, Amendment 73 to the Encouragement of Capital Investments Law was published. This amendment sets new benefit tracks, inter alia, “Preferred Technological Enterprise” and “Special Preferred Technological Enterprise” (the “Capital Investments Law Amendment”).

To date, the Company has elected not to have the Capital Investments Law Amendment apply to the Company.

c. Tax losses carried forward to future years

As of December 31, 2024 and 2025, the Company had aggregate NOL carry-forwards equal to approximately $227.2 million and $219.8 million, respectively, that are available to reduce future taxable income as follows:

The Company

The Company’s carry-forward NOLs, equal to approximately $22.2 million and $20.0 million as of December 31, 2024 and 2025, respectively, may be restricted under Section 382 of the Internal Revenue Code (“IRC”). IRC Section 382 applies whenever a corporation with NOL experiences an ownership change. As a result of IRC Section 382, the taxable income for any post change year that may be offset by a pre-change NOL may not exceed the general IRC Section 382 limitation, which is the fair market value of the pre-change entity multiplied by the IRC long-term tax exempt rate.

Protalix Ltd.

At December 31, 2024 and 2025, the Israeli Subsidiary had approximately $205.0 million and $199.8 million, respectively, of carry-forward NOLs that are available to reduce future taxable income with no limited period of use.

Significant judgment is required in determining any valuation allowance recorded against deferred tax assets. In assessing the need for a valuation allowance, the Company considered all available evidence, including past operating results, the most recent projections for taxable income, and prudent and feasible tax planning strategies. The Company reassesses its valuation allowance periodically and if future evidence allows for a partial or full release of the valuation allowance, a tax benefit will be recorded accordingly.

d. Deferred income taxes:

The components of the Company’s net deferred tax assets at December 31, 2024 and 2025 were as follows:


		December 31,
(U.S. dollars in thousands)		2024			2025
In respect of:
Research and development expenses		$	3,055		$	3,717
Other timing differences			452			684
Net operating loss carry forwards			50,014			48,479
Valuation allowance			(50,665)			(50,364)
			2,856			2,516

Deferred taxes are computed using the tax rates expected to be in effect when those differences reverse.

e. Reconciliation of the theoretical tax expense to actual tax expense

A reconciliation of the statutory U.S. federal income tax rate of 21% in 2025 to the effective income tax rate is as follows:


		Year Ended December 31, 2025
(U.S. dollars in thousands)		$		%
U.S Federal Statutory tax rate			(1,178)	(21)
Foreign Tax Effects (Israel):
Change in Valuation allowances			(301)	(5)
Share based compensation			528	9
Other			(10)	-
Effect of changes in tax law enacted in the current period			105	2
Effect of Cross Border Tax Laws, net			1,735	31
Non-taxable or non-deductible items			117	2
Effective tax rate			996	18

A reconciliation of the statutory U.S. federal income tax rate of 21% in 2024 and 2023 to the effective income tax rate is as follows:


		Year Ended December 31,
(U.S. dollars in thousands)		2023			2024
Tax computed at the statutory U.S. income tax rate		$	1,799		$	872
Differences in tax rate			(899)			(436)
Statutorily non-deductible expenses			1,684			506
Change in Valuation allowances			(6,932)			(953)
Utilization of carry-forward losses and other temporary items without deferred taxes recognition			3,602			1,233
Withholding tax			1,000			-
		$	254		$	1,222

f. Valuation allowance roll-forward

The following table presents the change in the Company’s valuation allowance during the periods presented:


(U.S. dollars in thousands)
Balance at December 31, 2022	$	(58,550)
Additions to valuation allowance		(728)
Reductions to valuation allowance		7,660
Balance at December 31, 2023	$	(51,618)

Balance at December 31, 2023	$	(51,618)
Reductions to valuation allowance		953
Balance at December 31, 2024	$	(50,665)

Balance at December 31, 2024	$	(50,665)
Reductions to valuation allowance		301
Balance at December 31, 2025	$	(50,364)

g. Uncertain tax position


(U.S. dollars in thousands)
Balance at December 31, 2022	$	530
Increase for tax position related to current year		275
Balance at December 31, 2023	$	805

Balance at December 31, 2023	$	805
Increase for tax position related to current year		-
Balance at December 31, 2024	$	805

Balance at December 31, 2024	$	805
Increase for tax position related to current year		-
Balance at December 31, 2025	$	805

h. Tax assessments

In accordance with the Income Tax Ordinance, as of December 31, 2025, all of Protalix Ltd.’s tax assessments through tax year 2020 are considered final.

A summary of open tax years by major jurisdiction is presented below:


Jurisdiction:		Years:
Israel		2021-2025
United States (*)		2022-2025

(*)	Includes federal, state and local (or similar provincial jurisdictions) tax positions.

i. Income (loss) before taxes on income is composed of the following:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Domestic			(7,061)			(4,548)			(4,579)
Foreign			15,627			8,702			(1,029)
		$	8,566		$	4,154		$	(5,608)

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


			Year Ended December 31,
(U.S. dollars in thousands)		2023		2024		2025
Current taxes on income - US (federal)		$	3,346	$	986	$	656
Deferred taxes on income - US (federal)			(3,092)		236		340
Total taxes on income		$	254	$	1,222	$	996

Following the regulatory approvals of 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 the 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 IRC Section 174 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.

k. Income taxes paid:

The income taxes paid by the Company are as follows:


		Year ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
United States (federal)		$	-		$	385		$	1,183

- Definition

The entire disclosure for income tax.

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+ Details

SIGNIFICANT ACCOUNTING POLICIES (Policies)

12 Months Ended

Dec. 31, 2025

SIGNIFICANT ACCOUNTING POLICIES

General

a. General

The Company’s product pipeline currently includes, among other candidates:

PRX-115, the Company’s plant cell-expressed recombinant PEGylated uricase (urate oxidase) – a chemically modified enzyme to treat uncontrolled gout; and

PRX-119, the Company’s plant cell-expressed PEGylated recombinant human DNase I product candidate for long and customized systemic circulation in the bloodstream for NETs-related diseases.

not possible to predict the duration or severity of the ongoing conflict or its effects on the Company’s business, results of operations, and financial conditions.

Basis of presentation

b. Basis of presentation

The Company’s financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”).

Use of estimates in the preparation of financial statements

c. Use of estimates in the preparation of financial statements

Functional currency

d. Functional currency

Cash equivalents

e. Cash equivalents

Short-term bank deposits

f. Short-term bank deposits

Restricted deposit

g. Restricted deposit

Restricted deposit is deposited in an interested-bearing saving account which is used as a security for the Company's potential hedging activities.

Accounts Receivables

h. Accounts Receivables

No write-off activity and recoveries for the periods presented were recognized.

Inventories

i. Inventories

Inventories are valued at the lower of cost or net realizable value. Cost of raw and packaging materials and purchased products is determined using the “moving average” basis.

Inventory is written down for estimated obsolescence based upon management assumptions about future demand and market conditions.

Property and equipment

j. Property and equipment

1. Property and equipment are stated at cost, net of accumulated depreciation and amortization.

2. The Company’s assets are depreciated by the straight-line method on the basis of their estimated useful lives as follows:


		Years
Laboratory equipment		5
Furniture		10-15
Computer equipment		3

Leasehold improvements are amortized by the straight-line method over the shorter of (i) the expected lease term and (ii) the estimated useful life of the improvements.

Impairment of long-lived assets

k. Impairment of long-lived assets

Income taxes

l. Income taxes

1. Deferred income taxes

2. Uncertainty in income taxes

Revenue Recognition

m. Revenue Recognition

Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for performance obligations upon transfer of control to the customer.

Revenue is recognized net of any taxes collected from customers which are subsequently remitted to governmental entities (e.g., indirect taxes).

1. Revenues from selling products

The Company recognizes revenues from selling goods at a point in time when control over the product is transferred to customers (upon delivery).

2. Revenues from license and R&D services

Revenue from additional research and development services ordered by Chiesi, is recognized over time using the cost-to-cost method.

Research and development costs

n. Research and development costs

Concentration of credit risks and trade receivable

o. Concentration of credit risks and trade receivable

As of December 31, 2024 and 2025, the accounts receivables trade balance was composed of the following:


		December 31,
(U.S. dollars in thousands)		2024			2025
Chiesi		$	-		$	5,473
Pfizer			1,192			1,426
Fiocruz			1,717			1,941
		$	2,909		$	8,840

Share-based compensation

p. Share-based compensation

The Company measures compensation expense for restricted stock based on the market value of the underlying stock at the date of grant.

The Company elected to recognize compensation cost for awards to employees with only service conditions that have a graded vesting schedule using the accelerated method.

The Company elects to account for forfeitures as they occur.

Net earnings (loss) per share

q. Net earnings (loss) per share

Convertible notes

r. Convertible notes

Starting from January 1, 2024, the convertible debt instruments were accounted for as a single liability measured at amortized cost.

Leases

s. Leases

Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the consolidated balance sheets.

The Company applies the portfolio approach to account for the operating lease ROU assets and liabilities for certain car leases and incremental borrowing rates.

New accounting pronouncements

t. New accounting pronouncements

Recently adopted accounting pronouncements

Recently issued accounting pronouncements, not yet adopted

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY) - USD ($) $ in Thousands	Common Stock	Additional Paid-in Capital Adjustment	Additional Paid-in Capital	Accumulated Deficit Adjustment	Accumulated Deficit	Adjustment	Total
Beginning balance at Dec. 31, 2022	$ 54		$ 379,167		$ (389,861)		$ (10,640)
Beginning balance (in shares) at Dec. 31, 2022	53,790,167
Issuance of common stock under the Sales Agreement, net	$ 13		23,941				23,954
Issuance of common stock under the Sales Agreement, net (in shares)	12,560,150
Convertible notes conversions	$ 5		7,778				7,783
Convertible notes conversions (in shares)	4,691,623
Share-based compensation related to stock options			1,928				1,928
Share-based compensation related to restricted stock awards	$ 1		1,519				1,520
Share-based compensation related to restricted stock awards (in shares)	1,371,362
Exercise of warrants			712				712
Exercise of warrants (in shares)	538,822
Net income (loss)					8,312		8,312
Ending balance at Dec. 31, 2023	$ 73		415,045		(381,549)		33,569
Ending balance (in shares) at Dec. 31, 2023	72,952,124
Issuance of common stock under the Sales Agreement, net	$ 2		3,624				3,626
Issuance of common stock under the Sales Agreement, net (in shares)	2,216,692
Share-based compensation related to stock options			1,593				1,593
Share-based compensation related to restricted stock awards	$ 1		1,659				1,660
Share-based compensation related to restricted stock awards (in shares)	681,459
Net income (loss)					2,932		2,932
Ending balance (ASU 2020-06) at Dec. 31, 2024		$ (393)		$ 224		$ (169)
Ending balance at Dec. 31, 2024	$ 76		421,528		(378,393)		$ 43,211
Ending balance (in shares) at Dec. 31, 2024	75,850,275						75,850,275
Issuance of common stock under the Sales Agreement, net	$ 3		6,809				$ 6,812
Issuance of common stock under the Sales Agreement, net (in shares)	2,775,215
Share-based compensation related to stock options			1,494				1,494
Share-based compensation related to restricted stock awards			803				803
Share-based compensation related to restricted stock awards (in shares)	564,010
Exercise of warrants and options	$ 1		2,513				2,514
Exercise of warrants and options (in shares)	1,236,481
Net income (loss)					(6,604)		(6,604)
Ending balance at Dec. 31, 2025	$ 80		$ 433,147		$ (384,997)		$ 48,230
Ending balance (in shares) at Dec. 31, 2025	80,425,981						80,425,981

SEGMENT INFORMATION (Schedule of Disaggregation of Revenues) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
SEGMENT INFORMATION
TOTAL REVENUE	$ 52,744	$ 53,399	$ 65,494
GOODS
SEGMENT INFORMATION
TOTAL REVENUE	51,802	52,981	40,418
LICENSE AND R&D SERVICES
SEGMENT INFORMATION
TOTAL REVENUE	942	418	25,076
Pfizer \| GOODS
SEGMENT INFORMATION
TOTAL REVENUE	18,227	12,617	12,522
Fiocruz \| GOODS
SEGMENT INFORMATION
TOTAL REVENUE	11,062	11,031	10,401
Chiesi \| GOODS
SEGMENT INFORMATION
TOTAL REVENUE	$ 22,513	$ 29,333	$ 17,495

- Definition

Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss).

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
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-Section 50
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+ Details

OPERATING LEASES (Tables)

12 Months Ended

Dec. 31, 2025

OPERATING LEASES

Schedule of Operating Leases

The following table sets forth data regarding the Company’s operating leases for the years ended December 31, 2023, 2024, and 2025:


	Year Ended December 31,
(U.S. dollars in thousands)	2023			2024			2025
Operating lease costs	$	1,471		$	1,639		$	1,815
Cash paid for amounts included in the measurement of lease liabilities		1,484			1,634			1,804
Weighted average remaining lease term (in years)		6.8			6.0			22.6
Weighted average discount rate		12.8	%		12.8	%		13.4	%

Schedule of Maturity Analysis of Operating Leases

The following table sets forth a maturity analysis of the Company’s operating lease liabilities as of December 31, 2025:


(U.S. dollars in thousands)		December 31, 2025
First year		$	1,384
Second year		$	1,192
Third year		$	1,104
Fourth year		$	1,058
Fifth year and thereafter		$	22,445
Total undiscounted cash flows		$	27,183
Less: imputed interest		$	18,862
Present value of operating lease liabilities		$	8,321

TAXES ON INCOME (Schedule of Open Tax Years) (Details)	12 Months Ended
TAXES ON INCOME (Schedule of Open Tax Years) (Details)	Dec. 31, 2025
Minimum
Income Tax Contingency [Line Items]
Open tax year	2022
Maximum
Income Tax Contingency [Line Items]
Open tax year	2025
Israel \| Minimum
Income Tax Contingency [Line Items]
Open tax year	2021
Israel \| Maximum
Income Tax Contingency [Line Items]
Open tax year	2025

OPERATING LEASES (Additional Information) (Details)	12 Months Ended
OPERATING LEASES (Additional Information) (Details)	Dec. 31, 2025 USD ($) item facility	Aug. 31, 2025
OPERATING LEASES
Bank guarantee	$ 586,000
ROU asset adjustment	$ 3,100,000
Second option period
OPERATING LEASES
Option to extend	true
Number of facilities leased \| facility	3
Plan \| Third option period
OPERATING LEASES
Percentage of change in operating lease monthly rental payments	7.50%
Operating lease, term of agreement	5 years
Notice period for termination of lease agreement	6 months
Plan \| Fourth option period
OPERATING LEASES
Percentage of change in operating lease monthly rental payments	5.00%
Vehicles
OPERATING LEASES
Operating lease, term of agreement	3 years
Minimum
OPERATING LEASES
Percentage of change in operating lease monthly rental payments		7.50%
Maximum
OPERATING LEASES
Percentage of change in operating lease monthly rental payments		10.00%
Maximum \| Plan \| Third option period
OPERATING LEASES
Operating lease, renewable term \| item	4

TAXES ON INCOME (Reconciliation of Tax Expense) (Details) - USD ($) $ in Thousands	1 Months Ended	12 Months Ended
	May 31, 2023	Dec. 31, 2025	Dec. 31, 2024	Dec. 31, 2023
Amount
U.S Federal Statutory tax rate		$ (1,178)	$ 872	$ 1,799
Change in Valuation allowances	$ (3,100)		(953)	(6,932)
Effect of changes in tax law enacted in the current period		105	(436)	(899)
Utilization of carry-forward losses and other temporary items without deferred taxes recognition			1,233	3,602
Withholding tax				1,000
Effect of Cross Border Tax Laws, net		1,735
Non-taxable or non-deductible items:		117	506	1,684
Total taxes on income		$ 996	$ 1,222	$ 254
Tax Jurisdiction of Domicile [Extensible Enumeration]		country:US	country:US	country:US
Percentage
U.S Federal Statutory tax rate		(21.00%)	(21.00%)	(21.00%)
Effect of changes in tax law enacted in the current period		2.00%
Effect of Cross Border Tax Laws, net		31.00%
Non-taxable or non-deductible items		2.00%
Effective tax rate		18.00%
Israel
Amount
Change in Valuation allowances		$ (301)
Share based compensation		528
Other		$ (10)
Percentage
Change in Valuation allowances		(5.00%)
Share based compensation		9.00%

RELATED PARTY TRANSACTIONS

12 Months Ended

Dec. 31, 2025

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS

NOTE 15 - RELATED PARTY TRANSACTIONS

Non-Executive Director Compensation


		Year Ended December 31,
(U.S. dollars in thousands)		2023			2024			2025
Compensation (including share-based compensation) to the non-executive directors		$	429		$	555		$	478

In September 2023, with the consent of the Audit Committee of the Board of Directors, the Company engaged one of its non-executive directors to advise the Company regarding business development and licensing efforts on a consultancy basis. The engagement expired in September 2025. For the years ended December 31, 2023, 2024, and 2025, we recorded an expense of a total of $35,475, $1,350, and $0 for consulting fees under such engagement, respectively.

- Definition

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

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+ Details