0001558370-25-003039 | 10-K | XBRL Viewer | Protalix Biotherapeutics INC

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TAXES ON INCOME (Additional Information) (Details) - USD ($) $ in Thousands	1 Months Ended	12 Months Ended
	May 31, 2023	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
TAXES ON INCOME
Statutory income tax rate		21.00%	21.00%	21.00%
Amount of milestone payment received	$ 20,000
Valuation allowance related to deferred tax assets	$ (3,100)	$ (953)	$ (6,932)	$ (2,970)
Deferred tax liability of research and development costs		$ 11,900	14,400	$ 28,500
Amortization period research and development costs		15 years
Operating Loss Carryforwards		$ 227,200	234,800
Maximum
TAXES ON INCOME
Statutory income tax rate		21.00%
Subsidiaries
TAXES ON INCOME
Operating Loss Carryforwards		$ 205,000	$ 210,400
Subsidiaries \| Tax Year Thereafter
TAXES ON INCOME
Statutory income tax rate		23.00%	23.00%	23.00%	23.00%	23.00%	23.00%	23.00%
Parent Company
TAXES ON INCOME
Operating Loss Carryforwards		$ 22,200	$ 24,400
Chiesi Agreements
TAXES ON INCOME
Amount of milestone payment received			$ 20,000

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Accounts Payable and Accruals - Other) (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Accounts payable and accruals - other:
Payroll and related expenses	$ 1,343	$ 1,437
Interest payable		511
Provision for vacation	1,811	1,605
Accrued expenses	9,568	9,009
Royalties payable	1,080	637
Income tax payable	3,476	2,876
Payable to customer	2,056
Sales reserve		2,861
Property and equipment suppliers	254	614
Accounts payable and accruals - other	$ 19,588	$ 19,550

SHARE CAPITAL (Summary of Share Options Outstanding and Exercisable) (Details) - Employee Stock Option	12 Months Ended
	Dec. 31, 2024 $ / shares shares
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Number of options outstanding at end of year	7,402,295
Number of options exercisable	4,247,896
$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	5,899,166
Weighted average remaining contractual life	7 years 11 months 8 days
Number of options exercisable	2,744,767
Weighted average remaining contractual life	6 years 11 months 12 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	994,679
Weighted average remaining contractual life	4 years 7 months 9 days
Number of options exercisable	994,679
Weighted average remaining contractual life	4 years 7 months 9 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	435,500
Weighted average remaining contractual life	3 years 10 months 17 days
Number of options exercisable	435,500
Weighted average remaining contractual life	3 years 10 months 17 days
$17.20
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items]
Exercise price, upper range \| $ / shares	$ 17.2
Number of options outstanding at end of year	72,950
Weighted average remaining contractual life	2 months 15 days
Number of options exercisable	72,950
Weighted average remaining contractual life	2 months 15 days

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, 2021	$ 46		$ 368,852		$ (374,934)		$ (6,036)
Beginning balance (in shares) at Dec. 31, 2021	45,556,647
Issuance of common stock under the Sales Agreement, net	$ 7		8,229				8,236
Issuance of common stock under the Sales Agreement, net (in shares)	7,473,038
Share-based compensation related to stock options			1,124				1,124
Share-based compensation related to restricted stock awards	$ 1		960				961
Share-based compensation related to restricted stock awards (in shares)	759,482
Exercise of warrants			2				2
Exercise of warrants (in shares)	1,000
Net income (loss)					(14,927)		(14,927)
Ending balance at Dec. 31, 2022	$ 54		379,167		(389,861)		(10,640)
Ending 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 (ASU 2020-06) at Dec. 31, 2023		$ (393)		$ 224		$ (169)
Ending balance at Dec. 31, 2023	$ 73		415,045		(381,549)		$ 33,569
Ending balance (in shares) at Dec. 31, 2023	72,952,124						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 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

Pay vs Performance Disclosure - USD ($) $ in Thousands	12 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
Pay vs Performance Disclosure
Net Income (Loss)	$ 2,932	$ 8,312	$ (14,927)

- 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

NET EARNINGS (LOSS) PER SHARE (Tables)

12 Months Ended

Dec. 31, 2024

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)		2022		2023		2024
Numerator:
Net income (loss) for diluted calculation	$	(14,927)	$	8,312	$	2,932
Add:
Financial expenses of 2024 Notes*				(1,168)		39
Net income (loss) for diluted calculation	$	(14,927)	$	7,144	$	2,971
Denominator:
Weighted average shares of Common Stock outstanding for basic calculation		48,472,159		67,512,527		72,530,698
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		48,472,159		82,424,016		81,057,176

* 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 (Tables)

12 Months Ended

Dec. 31, 2024

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

Schedule of Supplemental Information of Balance Sheets



	December 31,
(U.S. dollars in thousands)	2023		2024
a. Other assets:
Institutions	$	482	$	486
Prepaid expenses		444		500
Sundry		129		110
	$	1,055	$	1,096


	December 31,
(U.S. dollars in thousands)	2023		2024
b. Accounts payable and accruals – other:
Payroll and related expenses	$	1,437	$	1,343
Interest payable		511		-
Provision for vacation		1,605		1,811
Accrued expenses		9,009		9,568
Royalties payable		637		1,080
Income tax payable		2,876		3,476
Payable to customer		-		2,056
Sales reserves (1)		2,861		-
Property and equipment suppliers		614		254
	$	19,550	$	19,588

(1) The balance as of December 31, 2024 is based on a final reconciliation that was performed with the customer.

SIGNIFICANT ACCOUNTING POLICIES (The Impact to the Company's Consolidated Balance Sheet) (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
SIGNIFICANT ACCOUNTING POLICIES
Convertible notes	$ 0	$ 20,251
Additional paid-in capital	421,528	415,045
Accumulated deficit	$ 378,393	381,549
ASU 2020-06 \| Cumulative Effect, Period of Adoption, Adjusted Balance
SIGNIFICANT ACCOUNTING POLICIES
Convertible notes		20,420
Additional paid-in capital		414,652
Accumulated deficit		381,325
ASU 2020-06 \| Effect of Change
SIGNIFICANT ACCOUNTING POLICIES
Convertible notes		169
Additional paid-in capital		(393)
Accumulated deficit		$ 224

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

TAXES ON INCOME (Tables)

12 Months Ended

Dec. 31, 2024

TAXES ON INCOME

Schedule of Taxes on Income

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


		Year Ended December 31,
(U.S. dollars in thousands)	2022		2023		2024
Current taxes on income	$	530	$	3,346	$	986
Deferred taxes on income				(3,092)		236
Total taxes on income	$	530	$	254	$	1,222

Schedule of Deferred Tax Assets

The components of the Company’s net deferred tax assets at December 31, 2023 and 2024 were as follows:


	December 31,
(U.S. dollars in thousands)	2023		2024
In respect of:
Research and development expenses	$	4,625	$	3,055
Other timing differences		(1,387)		452
Net operating loss carry forwards		51,472		50,014
Valuation allowance		(51,618)		(50,665)
		3,092		2,856

Schedule of Reconciliation of Tax Expense

A reconciliation of the statutory U.S. federal income tax rate of 21% in 2024, 2023 and 2022 to the effective income tax rate is as follows:


	Year Ended December 31,
(U.S. dollars in thousands)	2022		2023		2024
Tax computed at the statutory U.S. income tax rate	$	(3,023)	$	1,799	$	872
Differences in tax rate		1,512		(899)		(436)
Statutorily non-deductible expenses		2,979		1,684		506
Change in Valuation allowances		(2,970)		(6,932)		(953)
Utilization of carry-forward losses and other temporary items without deferred taxes recognition		2,032		3,602		1,233
Withholding tax		-		1,000		-
	$	530	$	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)
Additions to valuation allowance		-
Reductions to valuation allowance		953
Balance at December 31, 2024	$	(50,665)

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

Schedule of Open Tax Years

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


Jurisdiction:		Years:
Israel		2020-2024
United States (*)		2021-2024

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

NET EARNINGS (LOSS) PER SHARE

12 Months Ended

Dec. 31, 2024

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)		2022		2023		2024
Numerator:
Net income (loss) for diluted calculation	$	(14,927)	$	8,312	$	2,932
Add:
Financial expenses of 2024 Notes*				(1,168)		39
Net income (loss) for diluted calculation	$	(14,927)	$	7,144	$	2,971
Denominator:
Weighted average shares of Common Stock outstanding for basic calculation		48,472,159		67,512,527		72,530,698
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		48,472,159		82,424,016		81,057,176

* 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.

Diluted loss per share do not include 34,097,716 shares of Common Stock underlying outstanding stock options, warrants and convertible notes of the Company for the year ended December 31, 2022 because the effect would be anti-dilutive. 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 warrants and stock options because the effect would be anti-dilutive.

NET EARNINGS (LOSS) PER SHARE (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
Numerator:
Net Income (Loss)	$ 2,932	$ 8,312	$ (14,927)
Financial expenses of 2024 Notes	39	(1,168)
Net income (loss) for diluted calculation	$ 2,971	$ 7,144	$ (14,927)
Denominator:
Weighted average shares of Common Stock outstanding for basic calculation	72,530,698	67,512,527	48,472,159
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	81,057,176	82,424,016	48,472,159
Outstanding Stock Options And Warrants
Denominator:
Antidilutive securities excluded from computation of earnings per share, amount	16,661,907	18,254,264
Outstanding Stock Options Warrants And 2024 Notes
Denominator:
Antidilutive securities excluded from computation of earnings per share, amount			34,097,716

SEGMENT INFORMATION (Tables)

12 Months Ended

Dec. 31, 2024

SEGMENT INFORMATION

Schedule of Segment Information

Segment information:


	Year Ended December 31,
(U.S. dollars in thousands)	2022		2023		2024
Revenues from customers	$	47,638	$	65,494	$	53,399
Less:
Employee salaries and related expenses		19,388		24,075		21,780
Sub-contractors expense		24,181		14,008		8,682
interest expense		2,529		3,180		1,062
Interest income		(1,146)		(1,286)		(1,299)
Depreciation		1,086		1,191		1,304
Other segment expenses*		15,997		15,760		17,716
Income before income taxes		(14,397)		8,566		4,154
Taxes on income		530		254		1,222
Segment net income	$	(14,927)	$	8,312	$	2,932

* Other expenses included in net income 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)	2022		2023		2024
Gaucher disease:
Pfizer (Ireland)	$	12,403	$	12,522	$	12,617
Fiocruz (Brazil)	$	9,452	$	10,401	$	11,031
Fabry disease:
Chiesi (Italy)	$	3,437	$	17,495	$	29,333
Total revenues from selling goods	$	25,292	$	40,418	$	52,981
Revenues from license and R&D services	$	22,346	$	25,076	$	418

SUBSEQUENT EVENTS

12 Months Ended

Dec. 31, 2024

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

NOTE 16 - SUBSEQUENT EVENTS

Since December 31, 2024, the Company has collected approximately $4.0 million from sales to Pfizer and approximately $2.9 million from sales to Brazil.

Since December 31, 2024, the Company sold, in the aggregate 1,223,935 shares of Common Stock under the 2023 Sales Agreement. The Company generated gross proceeds equal to approximately $2.5 million in connection with such sales. As a result of such sales, no shares remain available for sale under the 2023 Sales Agreement and the ATM program thereunder is now complete.

Since December 31, 2024, the Company issued 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. The warrants expired on March 11, 2025. Accordingly, as of March 12, 2025, no warrants remain outstanding.

In January 2025, the Company deregistered Protalix BV in the Netherlands thereby ending its corporate existence.

LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT

12 Months Ended

Dec. 31, 2024

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. In the years ended December 31, 2022, 2023 and 2024, the Company deposited approximately $96,000, $142,000 and $32,000, respectively, with insurance companies in connection with its severance payment obligations.

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”).

The amounts of severance pay expenses were approximately $945,000, $801,000 and $820,000 for each of the years ended December 31, 2022, 2023 and 2024, respectively, of which approximately $800,000, $798,000 and $859,000 in the years ended December 31, 2022, 2023 and 2024, respectively, were in respect of the Contribution Plans. Gain (loss) on amounts funded in respect of employee rights upon retirement totaled approximately $(3,000), $50,000 and $18,000 for the years ended December 31, 2022, 2023 and 2024, respectively.

The Company expects to contribute approximately $956,000 in the year ending December 31, 2025 to insurance companies in connection with its severance liabilities, approximately $931,000 of which will be contributed to one or more Contribution Plans.

During the five-year period following December 31, 2024, the Company expects that up to 10 employees may retire upon normal retirement age.

- Definition

The entire disclosure for retirement benefits.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 715
-SubTopic 70
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480794/715-70-50-1

Reference 2: http://www.xbrl.org/2003/role/exampleRef
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-Name Accounting Standards Codification
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-Paragraph 17
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480482/715-20-55-17

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: 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 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 715
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-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480126/715-20-S99-2

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480266/715-60-50-3

+ Details

RELATED PARTY TRANSACTIONS (Tables)

12 Months Ended

Dec. 31, 2024

RELATED PARTY TRANSACTIONS

Schedule of Related Party Transactions

Non-Executive Director Compensation


	Year Ended December 31,
(U.S. dollars in thousands)	2022		2023		2024
Compensation (including share-based compensation) to the non-executive directors	$	368	$	429	$	555

INVENTORIES

12 Months Ended

Dec. 31, 2024

INVENTORIES

INVENTORIES

NOTE 4 - INVENTORIES

Inventories at December 31, 2023 and 2024 consisted of the following:


	December 31,
(U.S. dollars in thousands)	2023		2024
Raw materials	$	4,176	$	4,549
Work in progress		9,055		11,245
Finished goods		5,814		5,449
Total inventory	$	19,045	$	21,243

b. During the years ended December 31, 2022, 2023 and 2024, the Company recorded approximately $0.04 million, $0.8 million and $0.09 million, respectively, for write-down of inventory under cost of goods sold.

PROPERTY AND EQUIPMENT (Schedule of Property and Equipment) (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	$ 40,330	$ 39,661
Less - accumulated depreciation and amortization	(35,739)	(34,688)
Property, plant and equipment, net, total	4,591	4,973
Laboratory equipment
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	19,043	18,933
Furniture and computer equipment
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	3,374	3,084
Leasehold improvements
Property, Plant and Equipment [Line Items]
Property, plant and equipment, gross	$ 17,913	$ 17,644

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Other Assets) (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Other assets:
Institutions	$ 486	$ 482
Prepaid expenses	500	444
Sundry	110	129
Other assets	$ 1,096	$ 1,055

SHARE CAPITAL (Schedule of Stock Option Valuation Assumptions) (Details) - Employee Stock Option - $ / shares	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Weighted average grants date fair value (USD)	$ 1.1	$ 1.84	$ 1.03
Exercise price (USD)	$ 1.1	$ 1.84	$ 1.03
Risk free rate	3.55%	4.44%	3.32%
Volatility	79.29%	79.41%	85.94%
Dividend yield	0.00%	0.00%	0.00%
Expected life (Years)	5 years 9 months	5 years 9 months	6 years

- 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 35
-Paragraph 1D
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480483/718-10-35-1D

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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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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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 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

OPERATING LEASES

12 Months Ended

Dec. 31, 2024

OPERATING LEASES

OPERATING LEASES

NOTE 7 - OPERATING LEASES

The Company is a party to several lease agreements for its facilities, the latest of which has been extended until 2026. The Company has the option to extend certain of such agreements on one additional occasion for an additional five-year period. During the extended lease period, the aggregate monthly rental payments will increase by 7.5%-10% for the option. The Company expects to exercise the final option in future periods. As of December 31, 2024, the Company provided bank guarantees of approximately $513,000, in the aggregate, to secure the fulfillment of its obligations under the lease agreements.

The Company 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, 2022, 2023 and 2024:


	Year ended December 31,
(U.S. dollars in thousands)	2022			2023			2024
Operating lease costs	$	1,398		$	1,471		$	1,639
Cash paid for amounts included in the measurement of lease liabilities		1,404			1,484			1,634
Weighted average remaining lease term (in years)		8.2			6.8			6.0
Weighted average discount rate		12.8	%		12.8	%		12.8	%

The following table sets forth a maturity analysis of the Company’s operating lease liabilities as of December 31, 2024:


(U.S. dollars in thousands)	December 31, 2024
2025	$	1,500
2026	$	1,241
2027	$	1,085
2028	$	1,040
2029 and thereafter	$	3,003
Total undiscounted cash flows	$	7,869
Less: imputed interest	$	2,343
Present value of operating lease liabilities	$	5,526

INVENTORIES (Schedule of Inventory) (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
INVENTORIES
Raw materials	$ 4,549	$ 4,176
Work in progress	11,245	9,055
Finished goods	5,449	5,814
Total inventory	$ 21,243	$ 19,045

CONVERTIBLE NOTES (Tables)

12 Months Ended

Dec. 31, 2024

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)	2022		2023		2024*
Contractual interest expense	$	2,156	$	2,534	$	1,022
Amortization of debt issuance costs and debt discount		300		267		—
Total	$	2,456	$	2,801	$	1,022

* See also Note 1(r).

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

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Dec. 31, 2024	Dec. 31, 2023
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	75,850,275	72,952,124
Common Stock, outstanding	75,850,275	72,952,124

OPERATING LEASES (Tables)

12 Months Ended

Dec. 31, 2024

OPERATING LEASES

Schedule of Operating Leases

The following table sets forth data regarding the Company’s operating leases for the years ended December 31, 2022, 2023 and 2024:


	Year ended December 31,
(U.S. dollars in thousands)	2022			2023			2024
Operating lease costs	$	1,398		$	1,471		$	1,639
Cash paid for amounts included in the measurement of lease liabilities		1,404			1,484			1,634
Weighted average remaining lease term (in years)		8.2			6.8			6.0
Weighted average discount rate		12.8	%		12.8	%		12.8	%

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, 2024:


(U.S. dollars in thousands)	December 31, 2024
2025	$	1,500
2026	$	1,241
2027	$	1,085
2028	$	1,040
2029 and thereafter	$	3,003
Total undiscounted cash flows	$	7,869
Less: imputed interest	$	2,343
Present value of operating lease liabilities	$	5,526

SEGMENT INFORMATION

12 Months Ended

Dec. 31, 2024

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 CODM. The CODM makes decisions on resource allocation, assesses performance of the business and monitors budget versus actual results on a consolidated basis.

Segment information:


	Year Ended December 31,
(U.S. dollars in thousands)	2022		2023		2024
Revenues from customers	$	47,638	$	65,494	$	53,399
Less:
Employee salaries and related expenses		19,388		24,075		21,780
Sub-contractors expense		24,181		14,008		8,682
interest expense		2,529		3,180		1,062
Interest income		(1,146)		(1,286)		(1,299)
Depreciation		1,086		1,191		1,304
Other segment expenses*		15,997		15,760		17,716
Income before income taxes		(14,397)		8,566		4,154
Taxes on income		530		254		1,222
Segment net income	$	(14,927)	$	8,312	$	2,932

* Other expenses included in net income 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)	2022		2023		2024
Gaucher disease:
Pfizer (Ireland)	$	12,403	$	12,522	$	12,617
Fiocruz (Brazil)	$	9,452	$	10,401	$	11,031
Fabry disease:
Chiesi (Italy)	$	3,437	$	17,495	$	29,333
Total revenues from selling goods	$	25,292	$	40,418	$	52,981
Revenues from license and R&D services	$	22,346	$	25,076	$	418

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

TAXES ON INCOME

12 Months Ended

Dec. 31, 2024

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 following table summarizes the Company’s taxes on income:


		Year Ended December 31,
(U.S. dollars in thousands)	2022		2023		2024
Current taxes on income	$	530	$	3,346	$	986
Deferred taxes on income				(3,092)		236
Total taxes on income	$	530	$	254	$	1,222

Following the regulatory approvals for Elfabrio in May 2023, the receipt of the $20.0 million milestone payment and the launch of Elfabrio in the United States, the Company released 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 Section 174 of the U.S. Tax Cuts and Jobs Act, which was enacted into law in December 2017 (the “TCJA”) which requires the Company to capitalize and amortize its research and development expenses over 15 years; and (iii) its forecasted profits in the United States following the regulatory approvals of Elfabrio.

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.

Section 174 of the TCJA requires taxpayers to capitalize and amortize research and development expenses for tax years beginning after December 31, 2021. This rule became effective for the Company during the year ended December 31, 2022, and resulted in the capitalization of research and development costs of approximately $28.5 million, $14.4 million and $11.9 million in 2022, 2023 and 2024, respectively. The Company will amortize these costs for tax purposes over 15 years for research and development performed outside the United States and over five years in the United States.

The Company believes that all future profits of its Subsidiaries will be indefinitely reinvested or that there is no expectation to distribute any taxable dividends from these Subsidiaries. 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” or “Benefited 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 and “Benefited Enterprise” plan since 2009. The period of benefits in respect of the main enterprise of the Company has not yet commenced. The period during which the Company is entitled to benefits in connection with the Benefited Enterprise expired in 2022.

If the Israeli Subsidiary subsequently pays a dividend out of income derived from the “Approved Enterprise” or “Benefited 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. Accelerated depreciation

The Israeli Subsidiary is entitled to claim accelerated depreciation, as provided by Israeli law, in the first five years of operation of each asset, in respect of buildings, machinery and equipment used by the Approved Enterprise and the Benefited Enterprise.

c. 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.

d. 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 2023, the Company had aggregate NOL carry-forwards equal to approximately $227.2 million and $234.8 million, respectively, that are available to reduce future taxable income as follows:

The Company

The Company’s carry-forward NOLs, equal to approximately $24.4 million and $22.2 million as of December 31, 2023 and 2024, 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, 2023 and 2024, the Israeli Subsidiary had approximately $210.4 million and $205.0 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, 2023 and 2024 were as follows:


	December 31,
(U.S. dollars in thousands)	2023		2024
In respect of:
Research and development expenses	$	4,625	$	3,055
Other timing differences		(1,387)		452
Net operating loss carry forwards		51,472		50,014
Valuation allowance		(51,618)		(50,665)
		3,092		2,856

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 2024, 2023 and 2022 to the effective income tax rate is as follows:


	Year Ended December 31,
(U.S. dollars in thousands)	2022		2023		2024
Tax computed at the statutory U.S. income tax rate	$	(3,023)	$	1,799	$	872
Differences in tax rate		1,512		(899)		(436)
Statutorily non-deductible expenses		2,979		1,684		506
Change in Valuation allowances		(2,970)		(6,932)		(953)
Utilization of carry-forward losses and other temporary items without deferred taxes recognition		2,032		3,602		1,233
Withholding tax		-		1,000		-
	$	530	$	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)
Additions to valuation allowance		-
Reductions to valuation allowance		953
Balance at December 31, 2024	$	(50,665)

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

h. Tax assessments

In accordance with the Income Tax Ordinance, as of December 31, 2024, all of Protalix Ltd.’s tax assessments through tax year 2019 are considered final.

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


Jurisdiction:		Years:
Israel		2020-2024
United States (*)		2021-2024

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

- Definition

The entire disclosure for income tax.

+ References

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-Topic 740
-SubTopic 10
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+ Details

INVENTORIES (Additional Information) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
INVENTORIES
Inventory write-down	$ 90	$ 800	$ 40

PROPERTY AND EQUIPMENT (Tables)

12 Months Ended

Dec. 31, 2024

PROPERTY AND EQUIPMENT

Schedule of Property and Equipment

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


	December 31,
(U.S. dollars in thousands)	2023		2024
Laboratory equipment	$	18,933	$	19,043
Furniture and computer equipment		3,084		3,374
Leasehold improvements		17,644		17,913
	$	39,661	$	40,330
Less – accumulated depreciation and amortization		(34,688)		(35,739)
	$	4,973	$	4,591

TAXES ON INCOME (Schedule of Open Tax Years) (Details)	12 Months Ended
TAXES ON INCOME (Schedule of Open Tax Years) (Details)	Dec. 31, 2024
Israel \| Minimum
Income Tax Contingency [Line Items]
Open tax year	2020
Israel \| Maximum
Income Tax Contingency [Line Items]
Open tax year	2024
UNITED STATES \| Minimum
Income Tax Contingency [Line Items]
Open tax year	2021
UNITED STATES \| Maximum
Income Tax Contingency [Line Items]
Open tax year	2024

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

12 Months Ended

Dec. 31, 2024

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

NOTE 14 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

a. Balance sheets:



	December 31,
(U.S. dollars in thousands)	2023		2024
a. Other assets:
Institutions	$	482	$	486
Prepaid expenses		444		500
Sundry		129		110
	$	1,055	$	1,096


	December 31,
(U.S. dollars in thousands)	2023		2024
b. Accounts payable and accruals – other:
Payroll and related expenses	$	1,437	$	1,343
Interest payable		511		-
Provision for vacation		1,605		1,811
Accrued expenses		9,009		9,568
Royalties payable		637		1,080
Income tax payable		2,876		3,476
Payable to customer		-		2,056
Sales reserves (1)		2,861		-
Property and equipment suppliers		614		254
	$	19,550	$	19,588

(1) The balance as of December 31, 2024 is based on a final reconciliation that was performed with the customer.

SIGNIFICANT ACCOUNTING POLICIES (Schedule of Useful Life) (Details)	Dec. 31, 2024
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

SHARE CAPITAL

12 Months Ended

Dec. 31, 2024

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 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, 2024, 4,139,412 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.

For purposes of determining the fair value of restricted stock granted to employees and non-employees, the Company’s management uses the fair value of the Common Stock. The fair value of options granted for both employees and directors is estimated at the date of grant using the Black-Scholes option-pricing model.

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, 2024, and the effect of share-based compensation on the statement of operations for the year ended December 31, 2024, is as follows:

Options granted to employees and directors:


	Year ended December 31, 2024
		Weighted
	Number	average
	of	exercise
	options	price
Outstanding at beginning of year	6,965,601	$	2.13
Changes during the year:
Granted	1,015,725		1.10
Forfeited	(326,969)		1.36
Expired	(252,062)		3.60
Outstanding at end of year	7,402,295	$	1.98
Exercisable at end of year	4,247,896	$	2.49

Restricted stock granted to employees:


	Year Ended December 31, 2024
			Weighted
	Number of		average
	Restricted		of fair value
	Stock		at grant date
Outstanding at beginning of year	1,173,670	$	2.16
Changes during the year:
Granted	704,869		1.24
Forfeited	(23,410)		1.99
Vested	(992,313)	$	1.91
Non vested at end of year	862,816	$	1.70

The following table summarizes information concerning outstanding and exercisable options as of December 31, 2024:


	December 31, 2024
	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	5,899,166	7.94	2,744,767	6.95
$3.55-$3.73	994,679	4.61	994,679	4.61
$4.69-$5.60	435,500	3.88	435,500	3.88
$17.20	72,950	0.21	72,950	0.21
	7,402,295		4,247,896

As of December 31, 2024, the aggregate intrinsic value of all the outstanding options and exercisable options was approximately $1.0 million and $0.5 million, respectively.

The weighted average grants date fair value of restricted stock granted in 2022, 2023 and 2024 was $0.82, $1.99 and $1.24, respectively.

The fair value of each option granted during 2022, 2023 and 2024 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,
	2022		2023		2024
Weighted average grants date fair value (USD)	1.03		1.84		1.10
Exercise price (USD)	1.03		1.84		1.10
Risk free rate	3.32	%	4.44	%	3.55	%
Volatility	85.94	%	79.41	%	79.29	%
Dividend yield	0	%	0	%	0	%
Expected life (Years)	6		5.75		5.75

The total unrecognized compensation cost of employee stock options at December 31, 2024 is approximately $1.3 million. The unrecognized compensation cost of employee stock options is expected to be recognized over a weighted average period of 0.8 years.

During the three years ended December 31, 2024, there were no exercises of stock options, and the Company did not realize any tax benefit in connection with any exercises.

The total vesting-date value of equity classified restricted stock vested during the year ended December 31, 2024 was $1.2 million. As of December 31, 2024, the unrecognized compensation cost related to all unvested equity classified restricted stock of $0.6 million is expected to be recognized as an expense over a weighted-average period of 0.7 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)	2022		2023		2024
Cost of goods sold	$	135	$	596	$	631
Research and development expenses		518		777		589
Selling, general and administrative expenses		1,432		2,075		2,033
	$	2,085	$	3,448	$	3,253

d. Private and 144A Offerings

During the year ended December 31, 2022, the Company issued 1,000 shares of Common Stock in connection with the cash exercise of a warrant issued in 2020 and generated proceeds equal to $2,360 from such exercise.

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.

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.

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, 2022, the Company sold, in the aggregate, 7,473,038 shares of Common Stock under the 2021 Sales Agreement. The Company generated gross proceeds equal to approximately $8.7 million in connection with such sales.

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. All such sales were completed during the quarters ended March 31, 2023 and June 30, 2023. No sales were completed during the six months ended December 31, 2023.

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). All such sales were completed during the quarter ended December 31, 2024. Subsequent to December 31, 2024, the Company sold the remaining amount of shares of Common Stock available for sale under the 2023 Sales Agreement thereby completing the ATM program thereunder.

- Definition

The entire disclosure for equity.

+ References

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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

PROPERTY AND EQUIPMENT

12 Months Ended

Dec. 31, 2024

PROPERTY AND EQUIPMENT

PROPERTY AND EQUIPMENT

NOTE 3 - PROPERTY AND EQUIPMENT

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


	December 31,
(U.S. dollars in thousands)	2023		2024
Laboratory equipment	$	18,933	$	19,043
Furniture and computer equipment		3,084		3,374
Leasehold improvements		17,644		17,913
	$	39,661	$	40,330
Less – accumulated depreciation and amortization		(34,688)		(35,739)
	$	4,973	$	4,591

b. Depreciation in respect of property and equipment totaled approximately $1.1 million, $1.2 million and $1.3 million for the years ended December 31, 2022, 2023 and 2024, respectively.

OPERATING LEASES (Schedule of Maturity Analysis of Operating Leases) (Details) $ in Thousands	Dec. 31, 2024 USD ($)
OPERATING LEASES
2025	$ 1,500
2026	1,241
2027	1,085
2028	1,040
2029 and thereafter	3,003
Total undiscounted cash flows	7,869
Less: imputed interest	2,343
Present value of operating lease liabilities	$ 5,526

COMMERCIALIZATION AGREEMENTS

12 Months Ended

Dec. 31, 2024

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 license in the entire world, including Israel but 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.

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, which has been reduced to $735.0 million.

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 (Tables)

12 Months Ended

Dec. 31, 2024

SHARE CAPITAL

Summary of Stock Option Activity

Options granted to employees and directors:


	Year ended December 31, 2024
		Weighted
	Number	average
	of	exercise
	options	price
Outstanding at beginning of year	6,965,601	$	2.13
Changes during the year:
Granted	1,015,725		1.10
Forfeited	(326,969)		1.36
Expired	(252,062)		3.60
Outstanding at end of year	7,402,295	$	1.98
Exercisable at end of year	4,247,896	$	2.49

Summary of Restricted Stock Activity

Restricted stock granted to employees:


	Year Ended December 31, 2024
			Weighted
	Number of		average
	Restricted		of fair value
	Stock		at grant date
Outstanding at beginning of year	1,173,670	$	2.16
Changes during the year:
Granted	704,869		1.24
Forfeited	(23,410)		1.99
Vested	(992,313)	$	1.91
Non vested at end of year	862,816	$	1.70

Summary of Share Options Outstanding and Exercisable

The following table summarizes information concerning outstanding and exercisable options as of December 31, 2024:


	December 31, 2024
	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	5,899,166	7.94	2,744,767	6.95
$3.55-$3.73	994,679	4.61	994,679	4.61
$4.69-$5.60	435,500	3.88	435,500	3.88
$17.20	72,950	0.21	72,950	0.21
	7,402,295		4,247,896

Schedule of Stock Option Valuation Assumptions


	Year Ended December 31,
	2022		2023		2024
Weighted average grants date fair value (USD)	1.03		1.84		1.10
Exercise price (USD)	1.03		1.84		1.10
Risk free rate	3.32	%	4.44	%	3.55	%
Volatility	85.94	%	79.41	%	79.29	%
Dividend yield	0	%	0	%	0	%
Expected life (Years)	6		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)	2022		2023		2024
Cost of goods sold	$	135	$	596	$	631
Research and development expenses		518		777		589
Selling, general and administrative expenses		1,432		2,075		2,033
	$	2,085	$	3,448	$	3,253

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Dec. 31, 2024
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

COMMERCIALIZATION AGREEMENTS (Details) - USD ($) $ in Millions	Jul. 23, 2018	Oct. 19, 2017	Dec. 31, 2024
Chiesi US Agreement
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		$ 735.0
Chiesi US Agreement \| Maximum
Payment on net sales percentage	40.00%
Chiesi US Agreement \| Minimum
Payment on net sales percentage	15.00%
Chiesi Ex-US Agreement
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
Chiesi Ex-US Agreement \| Maximum
Payment on net sales percentage		35.00%
Chiesi Ex-US Agreement \| Minimum
Payment on net sales percentage		15.00%

RELATED PARTY TRANSACTIONS (Details) - Related Party - Director - USD ($)	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
Related Party Transaction [Line Items]
Compensation (including share based compensation) to the non-executive directors	$ 555,000	$ 429,000	$ 368,000
Consulting fees	$ 1,350	$ 35,475

Document and Entity Information - USD ($) $ in Millions	12 Months Ended
Document and Entity Information - USD ($) $ in Millions	Dec. 31, 2024	Mar. 14, 2025	Jun. 30, 2024
Document and Entity Information
Document Type	10-K
Document Annual Report	true
Document Period End Date	Dec. 31, 2024
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 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			$ 82.0
Entity Common Stock, Shares Outstanding		78,032,585
Entity Central Index Key	0001006281
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	FY
Amendment Flag	false
Entity Voluntary Filers	No
Entity Well-known Seasoned Issuer	No
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 2025 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.

SEGMENT INFORMATION (Schedule of Disaggregation of Revenues) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
SEGMENT INFORMATION
TOTAL REVENUE	$ 53,399	$ 65,494	$ 47,638
GOODS
SEGMENT INFORMATION
TOTAL REVENUE	52,981	40,418	25,292
LICENSE AND R&D SERVICES
SEGMENT INFORMATION
TOTAL REVENUE	418	25,076	22,346
Pfizer \| GOODS
SEGMENT INFORMATION
TOTAL REVENUE	12,617	12,522	12,403
Fiocruz \| GOODS
SEGMENT INFORMATION
TOTAL REVENUE	11,031	10,401	9,452
Chiesi \| GOODS
SEGMENT INFORMATION
TOTAL REVENUE	$ 29,333	$ 17,495	$ 3,437

- 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).

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+ Details

COMMITMENTS

12 Months Ended

Dec. 31, 2024

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.

Royalty expenses to NATI or the IIA are included in the statement of operations as a component of the cost of revenues and were approximately $1.2 million, $1.9 million and $1.6 million during the years ended December 31, 2022, 2023 and 2024, respectively.

At December 31, 2023 and 2024, the maximum total royalty amount payable by the Company under these funding arrangements is approximately $35.5 million and $33.9 million, respectively (without interest, assuming 100% of the funds are payable).

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, 2024, total commitments under said agreements were approximately $1.5 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, including to support the global launch of 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.

SHARE CAPITAL (Summary of Stock Option Activity) (Details) - Employee Stock Option - Employees and directors	12 Months Ended
	Dec. 31, 2024 $ / shares shares
Number of options
Outstanding at beginning of year \| shares	6,965,601
Granted (in shares) \| shares	1,015,725
Forfeited (in shares) \| shares	(326,969)
Expired (in shares) \| shares	(252,062)
Outstanding at end of year \| shares	7,402,295
Exercisable at end of year \| shares	4,247,896
Weighted average exercise price
Outstanding at beginning of year \| $ / shares	$ 2.13
Granted \| $ / shares	1.1
Forfeited \| $ / shares	1.36
Expired \| $ / shares	3.6
Outstanding at end of year \| $ / shares	1.98
Exercisable at end of year \| $ / shares	$ 2.49

SHARE CAPITAL (Additional information) (Details)		6 Months Ended	12 Months Ended			21 Months Ended	36 Months Ended
SHARE CAPITAL (Additional information) (Details)	Jul. 02, 2021 USD ($)	Dec. 31, 2023 shares	Dec. 31, 2024 USD ($) Vote $ / shares shares	Dec. 31, 2023 USD ($) $ / shares shares	Dec. 31, 2022 USD ($) $ / shares shares	Mar. 31, 2023 USD ($) shares	Dec. 31, 2024 USD ($) Vote $ / shares shares	Feb. 27, 2023 USD ($)
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Common stock, authorized \| shares		185,000,000	185,000,000	185,000,000			185,000,000
Preferred stock, authorized \| shares			100,000,000				100,000,000
Preferred stock par value \| $ / shares			$ 0.0001				$ 0.0001
Number of voting rights \| Vote			1				1
Shares of Common Stock remain available for grant under the plan \| shares			4,139,412				4,139,412
Proceeds from Warrant Exercises			$ 0	$ 712,000	$ 2,000
Stock issuance proceeds			$ 3,626,000	$ 23,954,000	$ 8,236,000
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				17,475,171
Private Placement
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares issued (in shares) \| shares				301,810	1,000
Exercise of warrants (in shares) \| shares				237,012
Number of warrants issued (in shares) \| shares		845,000		845,000
Proceeds from Warrant Exercises				$ 700,000	$ 2,360
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				$ 900,000
ATM Shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares issued (in shares) \| shares		0		12,560,150
Stock issuance proceeds				$ 24,900,000
2021 Sales Agreement
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares issued (in shares) \| shares					7,473,038	13,980,060
Sale of stock, maximum offering price	$ 20,000,000
Stock issuance proceeds					$ 8,700,000	$ 20,000,000
2023 Sales Agreement
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares issued (in shares) \| shares			2,216,692
Sale of stock, maximum offering price								$ 20,000,000
Stock issuance proceeds			$ 3,800,000
Payments of Stock Issuance Costs			$ 100,000
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]
Exercised \| shares							0
Unrecognized compensation cost			$ 1,300,000				$ 1,300,000
Unrecognized weighted average period			9 months 18 days
Outstanding options intrinsic value			$ 1,000,000				1,000,000
Exercisable options intrinsic value			500,000				500,000
Restricted Stock
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Vesting-date fair value of stock vested			1,200,000
Unrecognized compensation cost			$ 600,000				$ 600,000
Unrecognized weighted average period			8 months 12 days
Granted \| $ / shares			$ 1.24	$ 1.99	$ 0.82

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
CURRENT ASSETS:
Cash and cash equivalents	$ 19,760	$ 23,634
Short-term bank deposits	15,070	20,926
Accounts receivable - Trade	2,909	5,272
Other assets	1,096	1,055
Inventories	21,243	19,045
Total current assets	60,078	69,932
NON-CURRENT ASSETS:
Funds in respect of employee rights upon retirement	462	528
Property and equipment, net	4,591	4,973
Deferred income tax asset	2,856	3,092
Operating lease right of use assets	5,430	5,909
Total assets	73,417	84,434
Accounts payable and accruals:
Trade	4,533	4,320
Other	19,588	19,550
Operating lease liabilities	1,500	1,409
Convertible notes	0	20,251
Total current liabilities	25,621	45,530
LONG TERM LIABILITIES:
Liability for employee rights upon retirement	559	714
Operating lease liabilities	4,026	4,621
Total long term liabilities	4,585	5,335
Total liabilities	30,206	50,865
COMMITMENTS
STOCKHOLDERS' EQUITY
Common Stock, $0.001 par value: Authorized - as of December 31, 2023 and 2024, 185,000,000 shares; issued and outstanding - as of December 31, 2023 and 2024, 72,952,124 and 75,850,275 shares, respectively	76	73
Additional paid-in capital	421,528	415,045
Accumulated deficit	(378,393)	(381,549)
Total stockholders' equity	43,211	33,569
Total liabilities and stockholders' equity	$ 73,417	$ 84,434

Insider Trading Policies and Procedures	12 Months Ended
Insider Trading Policies and Procedures	Dec. 31, 2024
Insider Trading Policies and Procedures [Line Items]
Insider Trading Policies and Procedures Adopted	true

FAIR VALUE MEASUREMENT

12 Months Ended

Dec. 31, 2024

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

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
TOTAL REVENUE	$ 53,399	$ 65,494	$ 47,638
COST OF GOODS SOLD	(24,319)	(22,982)	(19,592)
RESEARCH AND DEVELOPMENT EXPENSES	(12,970)	(17,093)	(29,349)
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES	(12,193)	(14,959)	(11,711)
OPERATING INCOME (LOSS)	3,917	10,460	(13,014)
FINANCIAL EXPENSES	(1,062)	(3,180)	(2,529)
FINANCIAL INCOME	1,299	1,286	1,146
FINANCIAL INCOME (EXPENSES), NET	237	(1,894)	(1,383)
INCOME (LOSS) BEFORE TAXES ON INCOME	4,154	8,566	(14,397)
TAXES ON INCOME	(1,222)	(254)	(530)
NET INCOME (LOSS)	$ 2,932	$ 8,312	$ (14,927)
EARNINGS (LOSS) PER SHARE OF COMMON STOCK - BASIC (in dollars per share)	$ 0.04	$ 0.12	$ (0.31)
EARNINGS (LOSS) PER SHARE OF COMMON STOCK - DILUTED (in dollars per share)	$ 0.04	$ 0.09	$ (0.31)
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING EARNINGS (LOSS) PER SHARE - BASIC (in shares)	72,530,698	67,512,527	48,472,159
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING EARNINGS (LOSS) PER SHARE - DILUTED (in shares)	81,057,176	82,424,016	48,472,159
Goods
TOTAL REVENUE	$ 52,981	$ 40,418	$ 25,292
License and R&D Services
TOTAL REVENUE	$ 418	$ 25,076	$ 22,346

PROPERTY AND EQUIPMENT (Additional Information) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
PROPERTY AND EQUIPMENT
Depreciation	$ 1,304	$ 1,191	$ 1,086

SIGNIFICANT ACCOUNTING POLICIES (Additional Information) (Details) $ / shares in Units, $ in Millions	1 Months Ended		12 Months Ended
	May 31, 2023 USD ($)	Oct. 31, 2015	Dec. 31, 2024 USD ($) item agreement $ / shares	Dec. 31, 2023 USD ($) $ / shares	Sep. 30, 2024	Aug. 25, 2021
SIGNIFICANT ACCOUNTING POLICIES
Number of global licensing and supply agreements \| agreement			2
Amount of milestone payment received	$ 20.0
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%	7.50%
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
Amount of milestone payment received				$ 20.0
Performance obligation number \| item			2

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

SIGNIFICANT ACCOUNTING POLICIES (Policies)

12 Months Ended

Dec. 31, 2024

SIGNIFICANT ACCOUNTING POLICIES

General

a. General

Protalix BioTherapeutics, Inc. (collectively with its subsidiary, the “Company”) and its wholly-owned subsidiaries, Protalix Ltd. and Protalix BV (collectively, the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx^® protein expression system (“ProCellEx”). 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 with Gaucher disease. Elfabrio, which the Company referred to as PRX-102 during its development stage, has been approved for marketing in the United States, the European Union, Great Britain, Switzerland, Peru, Israel, Russia and Singapore. The Company has partnered with Chiesi Farmaceutici S.p.A. (“Chiesi”) for the development and commercialization of Elfabrio.

The Company has licensed the rights to commercialize Elelyso worldwide (other than Brazil) to Pfizer Inc. (“Pfizer”), and in Brazil to Fundação Oswaldo Cruz (“Fiocruz”), an arm of the Brazilian Ministry of Health (the “Brazilian MoH”). Elelyso is marketed as BioManguinhos alfataliglicerase in Brazil.

The Company is committed to leveraging its track 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. 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.

On May 5, 2023, the European Commission (“EC”) announced that it had approved the Marketing Authorization Application (“MAA”) for Elfabrio and on May 9, 2023, the U.S. Food and Drug Administration (“FDA”) announced that it had approved the Biologics License Application (“BLA”) for Elfabrio (pegunigalsidase alfa), each for adult patients with a confirmed diagnosis of Fabry disease. Both approvals cover the 1 mg/kg every two weeks dosage.

The Company has entered into two exclusive global licensing and supply agreements for Elfabrio with Chiesi. On October 19, 2017, Protalix Ltd., the Company’s wholly-owned subsidiary, 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.

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:

(1)

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

(2)

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 in accordance with the exclusive license and supply agreement entered into between Protalix Ltd. and Pfizer, which is referred to herein as the Pfizer Agreement. In October 2015, Protalix Ltd. and Pfizer entered into an amended exclusive license and supply agreement, which is referred to herein as the Amended Pfizer Agreement, pursuant to which the Company sold to Pfizer its share in the collaboration created under the Pfizer Agreement for the commercialization of Elelyso. As part of the sale, the Company agreed to transfer its rights to Elelyso in Israel to Pfizer while gaining full rights to it in Brazil. Under the Amended Pfizer Agreement, 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 Fiocruz 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.

Because the Company’s operations are conducted in the State of Israel, the business and operations may be directly affected by economic, political, geopolitical and military conditions in Israel. In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel attacking a number of civilian and military targets while simultaneously launching extensive rocket attacks on the Israeli population and industrial centers. At the same time, clashes between Israel and Hezbollah in Lebanon increased. In response, Israel’s security cabinet declared war against the Hamas and a military campaign against these terrorist organizations commenced in parallel to their continued rocket and terror attacks. Moreover, the attacks by Hamas and Hezbollah, and Israel’s defensive measures, may result in a greater regional conflict. Since the outbreak of the war, other regional actors, including Iran, have taken military action against Israel. It is currently not possible to predict the duration or severity of the ongoing conflict or its effects on the Company’s business, operations and financial conditions. The situation could disrupt certain of the Company’s business and operations, among others. The Company has elected to store manufactured drug substance in multiple locations, both within and outside of Israel, to mitigate the risk of loss due to the military operations. As of the issuance of these financial statements, the impact of the war has not had an adverse effect on the Company’s operations.

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 as of December 31, 2024, are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued.

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

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.

Functional currency

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.

Cash equivalents

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.

Accounts Receivables

f. Accounts Receivables

Accounts receivable have been reduced by 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 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, 2024 and 2023, the allowance was negligible.

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

Inventories

g. 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.

Property and equipment

h. 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 in value of long-lived assets

i. Impairment in value of long-lived assets

The Company tests long-lived assets for impairment if an indication of impairment exists. If the sum of expected future cash flows of definite life assets (undiscounted) is less than the carrying amount of such assets, the Company recognizes an impairment loss, and writes down the assets to their estimated fair values.

Income taxes

j. 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.

Revenue recognition

k. 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.

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 transaction price is the consideration to which the Company expects to be entitled from the customer. 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.

2. Revenues from Chiesi Agreements

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.

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

3. Revenue from R&D services

Revenue from 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.

Research and development costs

l. 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.

Concentration of credit risks and trade receivable

m. Concentration of credit risks and trade receivable

Financial instruments that potentially subject the Company to concentration of credit risk consist principally of bank deposits 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, 2023, the accounts receivables balance was composed of $0.7 million from Chiesi and $4.6 million from Pfizer and as of December 31, 2024, the accounts receivables balance was composed of $1.7 million from Fiocruz and $1.2 million from Pfizer.

Share-based compensation

n. 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 has a graded vesting schedule using the accelerated method.

The Company elects to account for forfeitures as they occur.

Net earnings (loss) per share

o. 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 the convertible notes using the “if-converted” method.

Convertible notes

p. 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 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. See Note 1(r).

Leases

q. 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.

New accounting pronouncements

r. New accounting pronouncements

Recently adopted accounting pronouncements

In August 2020, the FASB issued ASU 2020-06 “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40)” (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for convertible instruments by removing certain separation models in ASC 470-20, Debt—Debt with Conversion and Other Options, for convertible instruments. ASU 2020-06 updates the guidance on certain embedded conversion features that are not required to be accounted for as derivatives under Topic 815, Derivatives and Hedging, or that do not result in substantial premiums accounted for as paid-in capital, such that those features are no longer required to be separated from the host contract. The convertible debt instruments will be accounted for as a single liability measured at amortized cost. This will also result in the interest expense recognized for convertible debt instruments to be typically closer to the coupon interest rate when applying the guidance in Topic 835. On January 1, 2024, the Company adopted ASU 2020-06 using the modified retrospective method of adoption. Under this method, the Company applied the guidance to the 2024 Notes at the adoption date and was required to make an adjustment to January 1, 2024, opening accumulated deficit balance and additional paid in capital. The prior period consolidated financial statements have not been retrospectively adjusted and continue to be reported under the accounting standards in effect for those periods. Under ASU 2020-06, the 2024 Notes (debt and conversion option) are accounted for as a liability. The impact to the Company’s consolidated balance sheet as of January 1, 2024 resulting from its adoption of ASU 2020-06 is as follows:


	As Reported		Updated
	December 31,		January 1,		Effect of
(U.S. dollars in thousands)	2023		2024		Change
Convertible notes	$	20,251	$	20,420	$	169
Additional paid in capital		415,045		414,652		(393)
Accumulated deficit		381,549		381,325		224

In November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures.” This guidance expands public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker (the “CODM”) and included within each reported measure of segment profit or loss and an amount and description of its composition for other segment items. The Company adopted this standard in the current period retrospectively to all prior periods presented in its consolidated financial statements. See Note 13.

Recently issued accounting pronouncements, not yet adopted

In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily 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 is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.

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.

CONVERTIBLE NOTES

12 Months Ended

Dec. 31, 2024

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)	2022		2023		2024*
Contractual interest expense	$	2,156	$	2,534	$	1,022
Amortization of debt issuance costs and debt discount		300		267		—
Total	$	2,456	$	2,801	$	1,022

* See also Note 1(r).

- 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 470
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)	$ 2,932	$ 8,312	$ (14,927)
Adjustments required to reconcile net income (loss) to net cash provided by (used in) operating activities:
Share-based compensation	3,253	3,448	2,085
Depreciation	1,304	1,191	1,086
Financial income, net	310	(446)	(989)
Changes in accrued liability for employee rights upon retirement	(151)	3	(543)
Changes in deferred income tax asset	236	(3,092)	0
Loss (gain) on amounts funded in respect of employee rights upon retirement	(18)	(50)	3
Loss (gain) on sale of fixed assets	(3)	9	0
Gain on conversions of convertible notes	0	(421)	0
Amortization of debt issuance costs and debt discount	0	267	300
Changes in operating assets and liabilities:
Decrease in contracts liability	0	(13,178)	(7,162)
Decrease (increase) in accounts receivable-trade and other assets	2,317	(428)	(1,194)
Changes in operating lease right of use assets, net	(4)	13	(5)
Decrease (increase) in inventories	(2,198)	(2,241)	1,150
Increase (decrease) in accounts payable and accruals	696	5,295	(4,804)
Net cash provided by (used in) operating activities	8,674	(1,318)	(25,000)
CASH FLOWS FROM INVESTING ACTIVITIES:
Investment in bank deposits	(15,000)	(20,420)	(16,000)
Short-term deposit withdrawal	20,420	5,000	11,000
Purchase of property and equipment	(1,282)	(1,149)	(628)
Proceeds from sale of property and equipment	3	0	0
Amounts paid (funded) in respect of employee rights upon retirement, net	80	(142)	593
Net cash provided by (used in) investing activities	4,221	(16,711)	(5,035)
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment for convertible notes redemption	(20,420)	0	0
Proceeds from issuance of common stock under the Sales Agreement, net	3,626	23,954	8,236
Exercise of warrants	0	712	2
Net cash provided by (used in) financing activities	(16,794)	24,666	8,238
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS	25	(114)	(77)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	(3,874)	6,523	(21,874)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR	23,634	17,111	38,985
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF YEAR	19,760	23,634	17,111
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
Purchase of property and equipment	254	614	143
Operating lease right of use assets obtained in exchange for new operating lease liabilities	376	1,567	794
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	385
Interest paid	1,532	2,742	2,198
Interest received	$ 1,487	$ 355	$ 93

SEGMENT INFORMATION (Schedule of Segment Information) (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2024 USD ($) segment	Dec. 31, 2023 USD ($)	Dec. 31, 2022 USD ($)
SEGMENT INFORMATION
Number of Operating Segments \| segment	1
Revenues from customers	$ 53,399	$ 65,494	$ 47,638
Employee salaries and related expenses	21,780	24,075	19,388
Sub-contractors expense	8,682	14,008	24,181
interest expense	1,062	3,180	2,529
Interest income	(1,299)	(1,286)	(1,146)
Depreciation	1,304	1,191	1,086
Other segment expenses	17,716	15,760	15,997
INCOME (LOSS) BEFORE TAXES ON INCOME	4,154	8,566	(14,397)
Income tax expenses	1,222	254	530
NET INCOME (LOSS)	$ 2,932	$ 8,312	$ (14,927)
Segment reporting description	Other expenses included in net income includes raw materials, rent and utilities and others.	Other expenses included in net income includes raw materials, rent and utilities and others.	Other expenses included in net income includes raw materials, rent and utilities and others.

RELATED PARTY TRANSACTIONS

12 Months Ended

Dec. 31, 2024

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS

NOTE 15 - RELATED PARTY TRANSACTIONS

Non-Executive Director Compensation


	Year Ended December 31,
(U.S. dollars in thousands)	2022		2023		2024
Compensation (including share-based compensation) to the non-executive directors	$	368	$	429	$	555

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. For the years ended December 31, 2023 and 2024, we recorded an expense of a total of $35,475 and $1,350 for such consulting fees, 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.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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-URI https://asc.fasb.org/1943274/2147480990/946-20-50-2

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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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: 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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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483326/850-10-50-1

+ Details

SIGNIFICANT ACCOUNTING POLICIES (Tables)

12 Months Ended

Dec. 31, 2024

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 ASU 2020-06 Impact to the Consolidated Balance Sheet

The impact to the Company’s consolidated balance sheet as of January 1, 2024 resulting from its adoption of ASU 2020-06 is as follows:


	As Reported		Updated
	December 31,		January 1,		Effect of
(U.S. dollars in thousands)	2023		2024		Change
Convertible notes	$	20,251	$	20,420	$	169
Additional paid in capital		415,045		414,652		(393)
Accumulated deficit		381,549		381,325		224

TAXES ON INCOME (Reconciliation of Tax Expense) (Details) - USD ($) $ in Thousands	1 Months Ended	12 Months Ended
	May 31, 2023	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
TAXES ON INCOME
Tax computed at the statutory U.S. income tax rate		$ 872	$ 1,799	$ (3,023)
Differences in tax rate		(436)	(899)	1,512
Statutorily non-deductible expenses		506	1,684	2,979
Change in Valuation allowances	$ (3,100)	(953)	(6,932)	(2,970)
Utilization of carry-forward losses and other temporary items without deferred taxes recognition		1,233	3,602	2,032
Withholding tax			1,000
Total taxes on income		$ 1,222	$ 254	$ 530

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 270
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (i)
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

OPERATING LEASES (Additional Information) (Details)	12 Months Ended
OPERATING LEASES (Additional Information) (Details)	Dec. 31, 2024 USD ($) item
Disclosure of Leases Operating [Line Items]
Option to extend	true
Operating lease, Renewable term \| item	1
Operating lease, term of agreement	5 years
Cash deposited as bank guarantee \| $	$ 513,000
Vehicles
Disclosure of Leases Operating [Line Items]
Operating lease, term of agreement	3 years
Minimum
Disclosure of Leases Operating [Line Items]
Percentage of change in operating lease monthly rental payments	7.50%
Maximum
Disclosure of Leases Operating [Line Items]
Percentage of change in operating lease monthly rental payments	10.00%

TAXES ON INCOME (Schedule of Deferred Tax Assets) (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
In respect of:
Research and development expenses	$ 3,055	$ 4,625
Other timing differences	452	(1,387)
Net operating loss carry forwards	50,014	51,472
Valuation allowance	(50,665)	(51,618)	$ (58,550)
Total net deferred tax assets	$ 2,856	$ 3,092

TAXES ON INCOME (Summary of Taxes on Income) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
TAXES ON INCOME
Current taxes on income	$ 986	$ 3,346	$ 530
Deferred taxes on income	236	(3,092)	0
Total taxes on income	$ 1,222	$ 254	$ 530

- Definition

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

+ References

+ Details

COMMITMENTS (Details) € in Millions	1 Months Ended		12 Months Ended
COMMITMENTS (Details) € in Millions	Nov. 30, 2024	Sep. 30, 2024 USD ($)	Dec. 31, 2024 USD ($)	Dec. 31, 2023 USD ($)	Dec. 31, 2022 USD ($)	Sep. 30, 2024 EUR (€)
Commitments And Contingencies [Line Items]
Purchase of property and equipment			$ 254,000	$ 614,000	$ 143,000
Chiesi Agreements
Commitments And Contingencies [Line Items]
Extended term of agreement		7 years
Contract amount \| €						€ 2.5
Fill/Finish Agreement
Commitments And Contingencies [Line Items]
Contracted share of facility cost amount		$ 400,000
Initial term of arrangement	10 years
Arrangement Other than Collaborative
Commitments And Contingencies [Line Items]
Subcontracting commitment amount			1,500,000
Royalty Agreement Terms \| Office of the Israeli Innovation Authority
Commitments And Contingencies [Line Items]
Royalty expense included in cost of revenue			$ 1,600,000	1,900,000	$ 1,200,000
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%
Accrued royalties			$ 33,900,000	$ 35,500,000

SIGNIFICANT ACCOUNTING POLICIES (Concentration of Credit Risks and Trade Receivable) (Details) - USD ($) $ in Thousands	Dec. 31, 2024	Dec. 31, 2023
Significant Accounting Policies [Line Items]
Accounts receivable - Trade	$ 2,909	$ 5,272
Fiocruz
Significant Accounting Policies [Line Items]
Accounts receivable - Trade	1,700
Chiesi
Significant Accounting Policies [Line Items]
Accounts receivable - Trade		700
Pfizer
Significant Accounting Policies [Line Items]
Accounts receivable - Trade	$ 1,200	$ 4,600

SUBSEQUENT EVENTS (Details) - USD ($)	3 Months Ended	6 Months Ended	12 Months Ended
SUBSEQUENT EVENTS (Details) - USD ($)	Mar. 16, 2025	Dec. 31, 2023	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022	Mar. 12, 2025
Subsequent Event [Line Items]
Stock issuance proceeds			$ 3,626,000	$ 23,954,000	$ 8,236,000
Exercise of warrants			$ 0	$ 712,000	$ 2,000
ATM Shares
Subsequent Event [Line Items]
Number of shares issued (in shares)		0		12,560,150
Stock issuance proceeds				$ 24,900,000
2023 Sales Agreement
Subsequent Event [Line Items]
Number of shares issued (in shares)			2,216,692
Stock issuance proceeds			$ 3,800,000
Private Placement
Subsequent Event [Line Items]
Number of shares issued (in shares)				301,810	1,000
Exercise of warrants				$ 700,000	$ 2,360
Exercise of warrants (in shares)				237,012
Number of warrants issued (in shares)		845,000		845,000
Subsequent Event \| 2023 Sales Agreement
Subsequent Event [Line Items]
Number of shares issued (in shares)	1,223,935
Stock issuance proceeds	$ 2,500,000
Shares remain for sale	0
Subsequent Event \| Private Placement
Subsequent Event [Line Items]
Number of shares issued (in shares)	908,000
Exercise of warrants	$ 2,100,000
Warrants and rights outstanding						0
Subsequent Event \| Pfizer Agreement
Subsequent Event [Line Items]
Total proceeds from sale of products	4,000,000
Subsequent Event \| Brazil Agreement with Fiocruz
Subsequent Event [Line Items]
Total proceeds from sale of products	$ 2,900,000

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

SHARE CAPITAL (Summary of Restricted Stock Activity) (Details) - Restricted Stock - $ / shares	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
Weighted average exercise price
Granted	$ 1.24	$ 1.99	$ 0.82
Employee
Number of options
Outstanding at beginning of year	1,173,670
Granted	704,869
Forfeited	(23,410)
Vested	(992,313)
Non vested at end of year	862,816	1,173,670
Weighted average exercise price
Outstanding at beginning of year	$ 2.16
Granted	1.24
Forfeited	1.99
Vested	1.91
Non vested at end of year	$ 1.7	$ 2.16

SHARE CAPITAL (Schedule of Stock-Based Compensation Expense in Statement of Operations) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	$ 3,253	$ 3,448	$ 2,085
Cost of goods sold
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	631	596	135
Research and development expenses
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	589	777	518
Selling, general and administrative expenses
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based compensation expense	$ 2,033	$ 2,075	$ 1,432

LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Details)	12 Months Ended
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Details)	Dec. 31, 2024 USD ($) employee	Dec. 31, 2023 USD ($)	Dec. 31, 2022 USD ($)
Employee severance obligation payments	$ 32,000	$ 142,000	$ 96,000
Severance expense	820,000	801,000	945,000
Contributions	859,000	798,000	800,000
Gain for the period	$ 18,000	$ 50,000	$ (3,000)
Maximum
Number of benefit eligible employees \| employee	10
Contribution to Insurance Companies
Contribution in connection with severance liabilities	$ 956,000
Contribution to Defined Contribution Plans
Contribution in connection with severance liabilities	$ 931,000

INVENTORIES (Tables)

12 Months Ended

Dec. 31, 2024

INVENTORIES

Schedule of Inventory

Inventories at December 31, 2023 and 2024 consisted of the following:


	December 31,
(U.S. dollars in thousands)	2023		2024
Raw materials	$	4,176	$	4,549
Work in progress		9,055		11,245
Finished goods		5,814		5,449
Total inventory	$	19,045	$	21,243

CONVERTIBLE NOTES (Schedule of Interest Expense Recognized) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
Amortization of debt issuance costs and debt discount	$ 0	$ 267	$ 300
2024 Notes
Contractual interest expense	1,022	2,534	2,156
Amortization of debt issuance costs and debt discount		267	300
Total	$ 1,022	$ 2,801	$ 2,456

SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2024

SIGNIFICANT ACCOUNTING POLICIES

SIGNIFICANT ACCOUNTING POLICIES

NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES

a. General

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

(1)

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

(2)

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.

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

d. Functional currency

e. Cash equivalents

f. Accounts Receivables

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

g. 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.

h. 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.

i. Impairment in value of long-lived assets

j. Income taxes

1. Deferred income taxes

2. Uncertainty in income taxes

k. Revenue Recognition

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.

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 Chiesi Agreements

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

3. Revenue from R&D services

l. Research and development costs

m. Concentration of credit risks and trade receivable

n. 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 has a graded vesting schedule using the accelerated method.

The Company elects to account for forfeitures as they occur.

o. Net earnings (loss) per share

p. Convertible notes

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

q. 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.

r. New accounting pronouncements

Recently adopted accounting pronouncements


	As Reported		Updated
	December 31,		January 1,		Effect of
(U.S. dollars in thousands)	2023		2024		Change
Convertible notes	$	20,251	$	20,420	$	169
Additional paid in capital		415,045		414,652		(393)
Accumulated deficit		381,549		381,325		224

Recently issued accounting pronouncements, not yet adopted

OPERATING LEASES (Schedule of Operating Leases) (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2024	Dec. 31, 2023	Dec. 31, 2022
OPERATING LEASES
Operating lease costs	$ 1,639	$ 1,471	$ 1,398
Cash paid for amounts included in the measurement of lease liabilities	$ 1,634	$ 1,484	$ 1,404
Weighted average remaining lease term (in years)	6 years	6 years 9 months 18 days	8 years 2 months 12 days
Weighted average discount rate	12.80%	12.80%	12.80%