0001104659-25-110824 | 10-Q | XBRL Viewer | Protalix Biotherapeutics INC

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OPERATING LEASES (Schedule of Operating Leases) (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
OPERATING LEASES
Operating lease costs	$ 476	$ 420	$ 1,395	$ 1,195
Cash paid for amounts included in the measurement of lease liabilities	$ 457	$ 413	$ 1,338	$ 1,207
Weighted average remaining lease term (in years)	22 years 7 months 6 days	6 years 2 months 12 days	22 years 7 months 6 days	6 years 2 months 12 days
Weighted average discount rate	13.40%	12.80%	13.40%	12.80%

STOCK TRANSACTIONS

9 Months Ended

Sep. 30, 2025

STOCK TRANSACTIONS

STOCK TRANSACTIONS

NOTE 5 – STOCK TRANSACTIONS

During the nine months ended September 30, 2025, 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. All such exercises were effected during the first quarter of 2025 and all unexercised warrants expired on March 11, 2025. Accordingly, as of March 12, 2025, no warrants remained outstanding.

During the nine months ended September 30, 2025, the Company sold, in the aggregate, 2,775,215 shares of Common Stock under the Sales Agreement. The Company generated gross proceeds equal to approximately $7.0 million in connection with such sales (issuance costs were $0.2 million). All such sales were effected during the first and second quarters of 2025.

During the nine months ended September 30, 2025, the Company issued, in the aggregate, 248,625 shares of Common Stock in connection with the exercise of options to purchase 248,625 shares of Common Stock by certain current and former employees of the Company. The Company received cash proceeds equal to $0.2 million in connection with such exercises. All such exercises were effected during the third quarter of 2025.

During the three months ended September 30, 2025, the Company granted, with the approval of the Company’s compensation committee, 10-year options to purchase 1,448,990 shares of Common Stock, in the aggregate, to certain of the Company’s officers, directors, other employees and a consultant under the Company’s Amended and Restated 2006 Employee Stock Incentive Plan, as amended (the “Plan”). The options generally vest over a three-year period in 12 equal quarterly increments. Vesting of the options granted to executive officers is subject to automatic acceleration in full upon a Corporate Transaction or a Change in Control, as those terms are defined in the Plan, and are subject to certain other terms and conditions. The Company estimated the aggregate fair value of the options on the applicable dates of grant

using the Black-Scholes option-pricing model to be approximately $1.5 million using the following assumptions (weighted average): stock price equal to $1.56, exercise price equal to $1.56, dividend yield of 0%, expected volatility of 73.64%, risk-free interest rate of 3.9% and expected life in years, 5.75.

During the three months ended September 30, 2025, the Company granted, with the approval of the Company’s compensation committee, 559,210 shares of restricted Common Stock, in the aggregate, to certain of the Company’s officers, directors, other employees and a consultant under the Plan. The shares of restricted Common Stock generally vest over a three-year period in 12 equal quarterly increments, with 52,910 of such shares of restricted Common Stock fully vested upon grant (September 22, 2025). Vesting of restricted Common Stock granted to executive officers is subject to automatic acceleration in full upon a Corporate Transaction or a Change in Control, as those terms are defined in the Plan, and are subject to certain other terms and conditions. The Company estimated the aggregate fair value of the restricted stock on the applicable dates of grant to be approximately $0.9 million using stock prices equal to $1.64 and $1.89.

- Definition

The entire disclosure for equity.

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+ Details

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2025	Nov. 01, 2025
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2025
Document Transition Report	false
Securities Act File Number	001-33357
Entity Registrant Name	PROTALIX BIOTHERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	65-0643773
Entity Address, Address Line One	2 University Plaza
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Hackensack
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07601
City Area Code	201
Local Phone Number	696-9345
Title of 12(b) Security	Common stock, $0.001 par value
Trading Symbol	PLX
Security Exchange Name	NYSEAMER
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		80,421,181
Entity Central Index Key	0001006281
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2025
Document Fiscal Period Focus	Q3
Amendment Flag	false

TAXES ON INCOME (TAX BENEFIT)

9 Months Ended

Sep. 30, 2025

TAXES ON INCOME (TAX BENEFIT)

TAXES ON INCOME (TAX BENEFIT)

NOTE 7 – TAXES ON INCOME (TAX BENEFIT)

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


		Nine Months Ended September 30,			Three Months Ended September 30,
(U.S. dollars in thousands)	2025		2024		2025		2024
Current taxes on income	$	91	$	164	$	(175)	$	164
Deferred taxes on income		177		236	$	59	$	443
Total taxes on income (tax benefit)	$	268	$	400	$	(116)	$	607

The Company had an effective tax rate of (32)% for the nine months ended September 30, 2025 compared to an effective tax rate of (13)% for the nine months ended September 30, 2024. For the nine months ended September 30, 2025, the difference between the Company’s effective tax rate and the U.S. federal statutory rate of 21% was the result of forecasted profits derived primarily from U.S. taxable GILTI income mainly due to Section 174 of the U.S. Tax Cuts and Jobs Act of 2017 (the “TCJA”), which was enacted in December 2017.

On July 4, 2025, tax reform legislation was enacted in the United States through the passage of H.R.1, One Big Beautiful Bill Act (“HR1”), which includes significant corporate tax changes, including a restoration of the current deductibility for domestic research expenditures beginning in 2025, with transition options for previously capitalized amounts.

- Definition

The entire disclosure for income tax.

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+ Details

SUBSEQUENT EVENTS

9 Months Ended

Sep. 30, 2025

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

NOTE 10 – SUBSEQUENT EVENTS

Since the end of the quarter ended September 30, 2025 and through the issuance of these financial statements, the Company collected approximately $3.0 million from sales to Fiocruz (Brazil), approximately $9.9 million from sales to Chiesi and $1.4 million from sales to Pfizer.

Since the end of the quarter ended September 30, 2025, the Company issued, in the aggregate, 79,856 shares of Common Stock in connection with the exercise of options to purchase 79,856 shares of Common Stock by a former employee and a current employee of the Company. The Company received cash proceeds equal to approximately $94,200 in connection with such exercise.

OPERATING LEASES

9 Months Ended

Sep. 30, 2025

OPERATING LEASES

OPERATING LEASES

NOTE 4 – OPERATING LEASES

The Company is a party to several lease agreements for its facilities that included varying lease periods and options for extensions. The Company is currently in the second option period for each of the three leases, which periods are not uniform. In the three months ended September 30, 2025, the Company amended all of the facility leases, collectively, to provide that the third option period for each lease will end on December 31, 2031 and will be associated with a unform rent increase equal to 7.5%. Thereafter, each lease will extend automatically, on an individual basis, for up to four additional five-year periods unless the Company provides the lessor with six months’ advance notice that it does not intend that any individual option extension become effective. Each option to renew a lease in each of the four option periods shall include a rent increase equal to 5% of the rent payable for the applicable previous option period. Prior to the amendment, the options to extend the leases were associated with increases of either 7.5% or 10%. The Company expects to exercise the options in future periods. As of September 30, 2025, the Company provided bank guarantees of approximately $0.6 million, in the aggregate, to secure the fulfillment of its obligations under the lease agreements.

The Company adjusted the operating lease right of use assets by $3.1 million reflecting the amount of remeasurement of the lease liability using a new discount rate at the amendment date.

The Company is a party to 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 three and nine months ended September 30, 2024 and 2025:


	Nine Months Ended September 30,						Three Months Ended September 30,
(U.S. dollars in thousands)	2025			2024			2025			2024
Operating lease costs	$	1,395		$	1,195		$	476		$	420
Cash paid for amounts included in the measurement of lease liabilities		1,338			1,207			457			413
Weighted average remaining lease term (in years)		22.6			6.2			22.6			6.2
Weighted average discount rate		13.4	%		12.8	%		13.4	%		12.8	%

The following table sets forth a maturity analysis of the Company’s operating lease liabilities as of September 30, 2025:


(U.S. dollars in thousands)	September 30, 2025
First year	$	1,397
Second year	$	1,141
Third year	$	1,074
Fourth year	$	1,040
Fifth year and thereafter	$	22,273
Total undiscounted cash flows	$	26,925
Less: imputed interest	$	18,748
Present value of operating lease liabilities	$	8,177

TAXES ON INCOME (TAX BENEFIT) (Tables)

9 Months Ended

Sep. 30, 2025

TAXES ON INCOME (TAX BENEFIT)

Schedule of Taxes on Income

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


		Nine Months Ended September 30,			Three Months Ended September 30,
(U.S. dollars in thousands)	2025		2024		2025		2024
Current taxes on income	$	91	$	164	$	(175)	$	164
Deferred taxes on income		177		236	$	59	$	443
Total taxes on income (tax benefit)	$	268	$	400	$	(116)	$	607

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Parenthetical) - $ / shares	Sep. 30, 2025	Dec. 31, 2024
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
Common Stock, Par or Stated Value Per Share	$ 0.001	$ 0.001
Common Stock, Shares Authorized	185,000,000	185,000,000

EARNINGS (LOSS) PER SHARE (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
Numerator:
Net income (loss)	$ 2,355	$ 3,236	$ (1,100)	$ (3,562)
Financial expenses of 2024 Notes		(503)
Net income (loss) for diluted calculation	$ 2,355	$ 2,733	$ (1,100)	$ (3,562)
Denominator:
Weighted average shares of Common Stock outstanding for basic calculation	79,281,685	73,549,745	78,225,112	73,301,091
Weighted average dilutive effect of 2024 Notes		7,667,323
Weighted average dilutive effect of stock options and restricted stock	1,532,879
Weighted average shares of Common Stock outstanding for diluted calculation	80,814,564	81,217,068	78,225,112	73,301,091
Outstanding Stock Options and Unvested Restricted Stock
Denominator:
Antidilutive securities excluded from computation of earnings (loss) per share, amount	3,745,682
Outstanding Stock Options, Unvested Restricted Stock and Warrants
Denominator:
Antidilutive securities excluded from computation of earnings (loss) per share, amount		20,173,438	11,288,007
Outstanding Stock Options, Unvested Restricted Stock, Warrants and Convertible Notes
Denominator:
Antidilutive securities excluded from computation of earnings (loss) per share, amount				30,515,287

INVENTORIES

9 Months Ended

Sep. 30, 2025

INVENTORIES

INVENTORIES

NOTE 2 - INVENTORIES

Inventories at September 30, 2025 and December 31, 2024 consisted of the following:


	September 30,		December 31,
(U.S. dollars in thousands)	2025		2024
Raw materials	$	4,983	$	4,549
Work in progress		5,355		11,245
Finished goods		10,917		5,449
Total inventory	$	21,255	$	21,243

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2025
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($)
$ in Thousands

Common Stock

Additional Paid-in Capital

Adjustment

Additional Paid-in Capital

Accumulated Deficit

Adjustment

Accumulated Deficit

Adjustment

Total

Beginning balance (ASU 2020-06) at Dec. 31, 2023

$ (393)

$ 224

$ (169)

Beginning balance at Dec. 31, 2023

$ 73

$ 415,045

$ (381,549)

$ 33,569

Beginning balance (in shares) at Dec. 31, 2023

^[1]

72,952,124

Share-based compensation related to stock options

1,191

Share-based compensation related to restricted stock awards

$ 1

1,407

1,408

Share-based compensation related to restricted stock awards (in shares)

^[1]

681,459

Net Income (Loss)

(3,562)

Ending balance at Sep. 30, 2024

$ 74

417,250

(384,887)

32,437

Ending balance (in shares) at Sep. 30, 2024

^[1]

73,633,583

Beginning balance at Jun. 30, 2024

$ 73

416,631

(388,123)

28,581

Beginning balance (in shares) at Jun. 30, 2024

^[1]

73,292,674

Share-based compensation related to stock options

358

Share-based compensation related to restricted stock awards

$ 1

261

262

Share-based compensation related to restricted stock awards (in shares)

^[1]

340,909

Net Income (Loss)

3,236

Ending balance at Sep. 30, 2024

$ 74

417,250

(384,887)

32,437

Ending balance (in shares) at Sep. 30, 2024

^[1]

73,633,583

Beginning balance at Dec. 31, 2024

$ 76

421,528

(378,393)

43,211

Beginning balance (in shares) at Dec. 31, 2024

^[1]

75,850,275

Issuance of common stock under the Sales Agreement, net

$ 3

6,809

6,812

Issuance of common stock under the Sales Agreement, net (in shares)

^[1]

2,775,215

Share-based compensation related to stock options

1,004

Share-based compensation related to restricted stock awards

561

Share-based compensation related to restricted stock awards (in shares)

^[1]

559,210

Exercise of warrants and options

$ 1

2,419

2,420

Exercise of warrants and options (in shares)

^[1]

1,156,625

Net Income (Loss)

(1,100)

Ending balance at Sep. 30, 2025

$ 80

432,321

(379,493)

52,908

Ending balance (in shares) at Sep. 30, 2025

^[1]

80,341,325

Beginning balance at Jun. 30, 2025

$ 80

431,671

(381,848)

49,903

Beginning balance (in shares) at Jun. 30, 2025

^[1]

79,732,115

Share-based compensation related to stock options

405

Share-based compensation related to restricted stock awards

193

Share-based compensation related to restricted stock awards (in shares)

^[1]

559,210

Exercise of warrants and options

Exercise of warrants and options (in shares)

^[1]

50,000

Net Income (Loss)

2,355

Ending balance at Sep. 30, 2025

$ 80

$ 432,321

$ (379,493)

$ 52,908

Ending balance (in shares) at Sep. 30, 2025

^[1]

80,341,325

[1]	Common stock, $0.001 par value; Authorized – as of September 30, 2025 and December 31, 2024 – 185,000,000 shares.

SEGMENT INFORMATION (Schedule of Segment Information) (Details) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2025 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2025 USD ($) segment	Sep. 30, 2024 USD ($)
SEGMENT INFORMATION
Number of Operating Segments \| segment			1
Number of reportable segments \| segment			1
Revenues from customers	$ 17,851	$ 17,959	$ 43,622	$ 35,181
Depreciation			1,078	970
INCOME (LOSS) BEFORE TAXES ON INCOME	2,239	3,843	(832)	(3,162)
Taxes on income (tax benefit)	(116)	607	268	400
NET INCOME (LOSS)	$ 2,355	$ 3,236	$ (1,100)	$ (3,562)
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.	Other expenses included in net income includes raw materials, rent and utilities and others.
Single operating segment
SEGMENT INFORMATION
Revenues from customers	$ 17,851	$ 17,959	$ 43,622	$ 35,181
Employee salaries and related expenses	5,853	4,734	16,502	15,091
Sub-contractors expense	1,886	1,649	9,348	6,413
Interest expense		260		1,021
Interest income	(289)	(212)	(817)	(970)
Depreciation	372	329	1,078	970
Other segment expenses	7,790	7,356	18,343	15,818
INCOME (LOSS) BEFORE TAXES ON INCOME	2,239	3,843	(832)	(3,162)
Taxes on income (tax benefit)	(116)	607	268	400
NET INCOME (LOSS)	$ 2,355	$ 3,236	$ (1,100)	$ (3,562)

SEGMENT INFORMATION

9 Months Ended

Sep. 30, 2025

SEGMENT INFORMATION

SEGMENT INFORMATION

NOTE 8 – 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:


	Nine Months Ended September 30,				Three Months Ended September 30,
(U.S. dollars in thousands)	2025		2024		2025		2024
Revenues from customers	$	43,622	$	35,181	$	17,851	$	17,959
Less:
Employee salaries and related expenses		16,502		15,091		5,853		4,734
Sub-contractors expense		9,348		6,413		1,886		1,649
Interest expense		—		1,021		—		260
Interest income		(817)		(970)		(289)		(212)
Depreciation		1,078		970		372		329
Other segment expenses*		18,343		15,818		7,790		7,356
Income (loss) before taxes on income		(832)		(3,162)		2,239		3,843
Taxes on income (tax benefit)		268		400		(116)		607
Segment net income (loss)	$	(1,100)	$	(3,562)	$	2,355	$	3,236

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

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


	Nine Months Ended September 30,				Three Months Ended September 30,
(U.S. dollars in thousands)	2025		2024		2025		2024
Gaucher disease:
Pfizer (Ireland)	$	15,431	$	11,431	$	2,805	$	3,430
Fiocruz (Brazil)	$	9,121	$	9,314	$	6,105	$	2,048
Fabry disease:
Chiesi (Italy)	$	18,556	$	14,075	$	8,763	$	12,361
Total revenues from selling goods	$	43,108	$	34,820	$	17,673	$	17,839
Revenues from license and R&D services	$	514	$	361	$	178	$	120

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

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
Pay vs Performance Disclosure
Net Income (Loss)	$ 2,355	$ 3,236	$ (1,100)	$ (3,562)

- 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

OPERATING LEASES (Additional Information) (Details) $ in Millions	9 Months Ended
	Sep. 30, 2025 USD ($) item facility	Jun. 30, 2025
OPERATING LEASES
Option to extend	true
Number of facilities leased \| facility	3
Operating lease, term of agreement	5 years
Notice period for termination of lease agreement	6 months
Operating lease rent increase rate for renewal period	5.00%
Percentage of change in operating lease monthly rental payments	7.50%
Bank guarantee	$ 0.6
ROU asset adjustment	3.1
Lease liability adjustment	$ 3.1
Vehicles
OPERATING LEASES
Operating lease, term of agreement	3 years
Minimum
OPERATING LEASES
Percentage of change in operating lease monthly rental payments		7.50%
Maximum
OPERATING LEASES
Operating lease, renewable term \| item	4
Percentage of change in operating lease monthly rental payments		10.00%

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Tables)

9 Months Ended

Sep. 30, 2025

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

Schedule of Supplemental Information of Balance Sheets


	September 30,		December 31,
(U.S. dollars in thousands)	2025		2024
Accounts payable and accruals – other:
Payroll and related expenses	$	745	$	1,343
Provision for vacation		2,209		1,811
Accrued expenses		8,126		9,568
Royalties payable		558		1,080
Income tax payable		2,385		3,476
Payable to customer		920		2,056
Property and equipment suppliers		230		254
	$	15,173	$	19,588

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Accounts Payable and Accruals - Other) (Details) - USD ($) $ in Thousands	Sep. 30, 2025	Dec. 31, 2024
Accounts payable and accruals - other:
Payroll and related expenses	$ 745	$ 1,343
Provision for vacation	2,209	1,811
Accrued expenses	8,126	9,568
Royalties payable	558	1,080
Income tax payable	2,385	3,476
Payable to customer	920	2,056
Property and equipment suppliers	230	254
Accounts payable and accruals - other	$ 15,173	$ 19,588

SIGNIFICANT ACCOUNTING POLICIES (Details) $ / shares in Units, $ in Millions	1 Months Ended
	Oct. 31, 2015	Sep. 30, 2025 USD ($) agreement $ / shares	Mar. 17, 2025 USD ($)	Jan. 31, 2025 $ / shares shares	Dec. 31, 2024 $ / shares	Sep. 30, 2024
SIGNIFICANT ACCOUNTING POLICIES
Number of global licensing and supply agreements \| agreement		2
Common Stock, Par or Stated Value Per Share (in dollars per share) \| $ / shares		$ 0.001			$ 0.001
Sales Agreement
SIGNIFICANT ACCOUNTING POLICIES
Shares remain for sale \| shares				0
Increase in aggregate gross sales price \| $			$ 20.0
Shares remain available, total gross proceeds \| $		$ 15.7
Common Stock, Par or Stated Value Per Share (in dollars per share) \| $ / shares				$ 0.001
2024 Notes
SIGNIFICANT ACCOUNTING POLICIES
Interest rate (as a percent)						7.50%
Amended Pfizer Agreement \| Protalix Bio Therapeutics Incorporation \| Brazil
SIGNIFICANT ACCOUNTING POLICIES
Collaborative arrangement revenues and expenses sharing percentage	100.00%

OPERATING LEASES (Schedule of Maturity Analysis of Operating Leases) (Details) $ in Thousands	Sep. 30, 2025 USD ($)
OPERATING LEASES
First year	$ 1,397
Second year	1,141
Third year	1,074
Fourth year	1,040
Fifth year and thereafter	22,273
Total undiscounted cash flows	26,925
Less: imputed interest	18,748
Present value of operating lease liabilities	$ 8,177

TAXES ON INCOME (TAX BENEFIT) (Summary of Taxes on Income) (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
TAXES ON INCOME (TAX BENEFIT)
Current taxes on income	$ (175)	$ 164	$ 91	$ 164
Deferred taxes on income	59	443	177	236
Total taxes on income (tax benefit)	$ (116)	$ 607	$ 268	$ 400

- 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/exampleRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

INVENTORIES (Schedule of Inventory) (Details) - USD ($) $ in Thousands	Sep. 30, 2025	Dec. 31, 2024
INVENTORIES
Raw materials	$ 4,983	$ 4,549
Work in progress	5,355	11,245
Finished goods	10,917	5,449
Total inventory	$ 21,255	$ 21,243

EARNINGS (LOSS) PER SHARE (Tables)

9 Months Ended

Sep. 30, 2025

EARNINGS (LOSS) PER SHARE

Schedule of Basic and Diluted Earnings (Loss) per Share

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


	Nine Months Ended September 30,					Three Months Ended September 30,
(In thousands, except share data)	2025		2024		2025		2024
Numerator:
Net income (loss)	$	(1,100)	$	(3,562)	$	2,355	$	3,236
Add:
Financial expenses of 2024 Notes*								(503)
Net income (loss) for diluted calculation	$	(1,100)	$	(3,562)	$	2,355	$	2,733
Denominator:
Weighted average shares of Common Stock outstanding for basic calculation		78,225,112		73,301,091		79,281,685		73,549,745
Weighted average dilutive effect of 2024 Notes								7,667,323
Weighted average dilutive effect of stock options and restricted stock						1,532,879
Weighted average shares of Common Stock outstanding for diluted calculation		78,225,112		73,301,091		80,814,564		81,217,068

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

SEGMENT INFORMATION (Tables)

9 Months Ended

Sep. 30, 2025

SEGMENT INFORMATION

Schedule of Segment Information

Segment information:


	Nine Months Ended September 30,				Three Months Ended September 30,
(U.S. dollars in thousands)	2025		2024		2025		2024
Revenues from customers	$	43,622	$	35,181	$	17,851	$	17,959
Less:
Employee salaries and related expenses		16,502		15,091		5,853		4,734
Sub-contractors expense		9,348		6,413		1,886		1,649
Interest expense		—		1,021		—		260
Interest income		(817)		(970)		(289)		(212)
Depreciation		1,078		970		372		329
Other segment expenses*		18,343		15,818		7,790		7,356
Income (loss) before taxes on income		(832)		(3,162)		2,239		3,843
Taxes on income (tax benefit)		268		400		(116)		607
Segment net income (loss)	$	(1,100)	$	(3,562)	$	2,355	$	3,236

* 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:


	Nine Months Ended September 30,				Three Months Ended September 30,
(U.S. dollars in thousands)	2025		2024		2025		2024
Gaucher disease:
Pfizer (Ireland)	$	15,431	$	11,431	$	2,805	$	3,430
Fiocruz (Brazil)	$	9,121	$	9,314	$	6,105	$	2,048
Fabry disease:
Chiesi (Italy)	$	18,556	$	14,075	$	8,763	$	12,361
Total revenues from selling goods	$	43,108	$	34,820	$	17,673	$	17,839
Revenues from license and R&D services	$	514	$	361	$	178	$	120

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (1,100)	$ (3,562)
Adjustments required to reconcile net loss to net cash provided by (used in) operating activities:
Share-based compensation	1,565	2,599
Depreciation	1,078	970
Financial expenses, net	136	173
Changes in accrued liability for employee rights upon retirement	14	32
Changes in deferred income tax asset	177	236
Gain on amounts funded in respect of employee rights upon retirement	(18)	(20)
Gain on sale of fixed assets		(3)
Changes in operating assets and liabilities:
Decrease (Increase) in accounts receivable-trade and other assets	(11,768)	3,069
Changes in operating lease right of use assets, net	(62)	13
Decrease (increase) in inventories	(12)	1,846
Decrease in accounts payable and accruals	(4,033)	(670)
Net cash provided by (used in) operating activities	(14,023)	4,683
CASH FLOWS FROM INVESTING ACTIVITIES:
Short-term deposit withdrawal		20,420
Purchase of property and equipment	(1,235)	(857)
Proceeds from sale of property and equipment		3
Amounts funded in respect of employee rights upon retirement, net	(19)	(25)
Net cash provided by (used in) investing activities	(1,254)	19,541
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment for convertible notes redemption		(20,420)
Proceeds from issuance of common stock under the Sales Agreement, net	6,812
Exercise of warrants and options	2,368
Net cash provided by (used in) financing activities	9,180	(20,420)
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS	(16)	(29)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	(6,113)	3,775
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD	19,760	23,634
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD	13,647	27,409
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
Purchase of property and equipment	230	402
Exercise of options	52
Operating lease right of use assets obtained in exchange for new operating lease liabilities	3,104	376
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS
Tax paid	1,182
Interest paid		1,532
Interest received	$ 258	$ 1,481

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
TOTAL REVENUE	$ 17,851	$ 17,959	$ 43,622	$ 35,181
COST OF GOODS SOLD	(8,324)	(8,375)	(22,374)	(20,433)
RESEARCH AND DEVELOPMENT EXPENSES	(4,467)	(2,998)	(13,934)	(8,846)
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES	(2,929)	(2,595)	(8,156)	(9,194)
OPERATING INCOME (LOSS)	2,131	3,991	(842)	(3,292)
FINANCIAL EXPENSES	(180)	(299)	(808)	(1,056)
FINANCIAL INCOME	288	151	818	1,186
FINANCIAL INCOME (EXPENSES), NET	108	(148)	10	130
INCOME (LOSS) BEFORE TAXES ON INCOME	2,239	3,843	(832)	(3,162)
TAXES ON INCOME (TAX BENEFIT)	(116)	607	268	400
NET INCOME (LOSS)	$ 2,355	$ 3,236	$ (1,100)	$ (3,562)
EARNINGS (LOSS) PER SHARE OF COMMON STOCK - BASIC (in dollars per share)	$ 0.03	$ 0.04	$ (0.01)	$ (0.05)
EARNINGS (LOSS) PER SHARE OF COMMON STOCK - DILUTED (in dollars per share)	$ 0.03	$ 0.03	$ (0.01)	$ (0.05)
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING EARNINGS (LOSS) PER SHARE - BASIC (in shares)	79,281,685	73,549,745	78,225,112	73,301,091
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING EARNINGS (LOSS) PER SHARE - DILUTED (in shares)	80,814,564	81,217,068	78,225,112	73,301,091
Goods
TOTAL REVENUE	$ 17,673	$ 17,839	$ 43,108	$ 34,820
License and R&D Services
TOTAL REVENUE	$ 178	$ 120	$ 514	$ 361

SIGNIFICANT ACCOUNTING POLICIES (Policies)

9 Months Ended

Sep. 30, 2025

SIGNIFICANT ACCOUNTING POLICIES

General

Protalix BioTherapeutics, Inc. (collectively with its subsidiary, the “Company”) and its wholly-owned subsidiary, Protalix Ltd., 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 and children four years of age and greater with Gaucher disease.

Elelyso was first approved by the U.S. Food and Drug Administration (“FDA”) in May 2012 and is now approved for marketing in 23 markets including Brazil, Israel and others. In May 2023, both the European Commission (“EC”) and the FDA announced the approval of Elfabrio, each for adult patients with a confirmed diagnosis of Fabry disease. Both approvals cover the 1 mg/kg every two weeks dosage. 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, Singapore, Australia and Taiwan.

The Company is committed to leveraging its record of success as the Company progresses with the development of treatments for rare and orphan diseases. In addition, the Company continuously works on the further development and enhancement of its ProCellEx technology. Accordingly, the Company is turning its focus to new, early-stage product candidates that treat indications for which there are high unmet needs in terms of efficacy and safety, including renal diseases. 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.

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 (neutrophil extracellular traps).

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.

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

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 and restated 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.

On February 27, 2023, the Company entered into that certain At The Market Offering Agreement (as may be amended from time to time, the “Sales Agreement”) with H.C. Wainwright & Co., LLC, as the Company’s sales agent (the “Agent”). After giving effect to the sales under the Sales Agreement in January 2025, no shares of common stock, par value $0.001 per share (the “Common Stock”), remained available for offer and sale under the Sales Agreement. On March 17, 2025, the Company entered into an amendment to the Sales Agreement pursuant to which the Company increased the aggregate gross sales price of shares of Common Stock available for offer and sale under the Sales Agreement by $20.0 million. As of September 30, 2025, approximately $15.7 million in shares of Common Stock remain available to be sold under the Sales Agreement.

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. Since October 2023, following an infiltration by Hamas terrorists of Israel’s southern border from the Gaza Strip and attacks on civilian and military targets, Israel has been engaged in military activity on a number of fronts, including with the Hamas in the Gaza Strip, Hezbollah in Lebanon, Iran, the Houthis terrorist group that controls parts of Yemen, and others. Such clashes may escalate in the future into a greater regional conflict. On October 9, 2025, Israel and Hamas entered into a ceasefire agreement intended to permanently end the war between Israel and Hamas. However, there are no assurances regarding continued compliance with such agreement. While the conflict created and continues to create heightened security concerns, disruptions to business operations, and economic instability within Israel, the ceasefire may contribute to improved regional stability. However, the security situation remains fluid and any renewed military actions, restrictions, or government-imposed measures could adversely affect the Company’s business, operations and financial condition. The Company’s facilities are deemed an “essential enterprise” which means it operates or can be operated for the purposes of state defense or public security or for the maintenance of essential supplies or services, allowing the Company to maintain operations during emergencies. The Company has elected to store manufactured drug substance in multiple locations, both within and outside of Israel, to mitigate the risk of loss. As of the issuance of these financial statements, the impact of the military action 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 September 30, 2025, 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

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal recurring nature) considered necessary for a fair statement of the results for the interim periods presented have been included. Operating results for the interim period are not necessarily indicative of the results that may be expected for the full year.

These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements in the Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company with the U.S. Securities and Exchange Commission (the “Commission”) on March 17, 2025. The comparative balance sheet at December 31, 2024 has been derived from the audited financial statements at that date. There have been no material changes in our significant accounting policies as described in our consolidated financial statements for the year ended December 31, 2024.

Net earnings (loss) per share

Basic earnings (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of Common Stock outstanding for each period.

Diluted earnings per share is calculated by dividing the net income by 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 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

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

Prior to January 1, 2024, the Company’s outstanding 2024 Notes were accounted for as a liability (debt) and equity component (conversion option) as the Company had the option to settle such notes may be settled wholly or partly in cash.

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

Recently issued accounting pronouncements, not yet adopted

Recently issued accounting pronouncements, not yet adopted

In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis with the option to apply the standard retrospectively. The Company expects the adoption of this standard to result in expanded disclosures in its consolidated financial statements.

In November 2024, the FASB issued ASU 2024-03 “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses,” which requires disclosure about the types of costs and expenses included in certain expense captions presented on the income statement. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted, and may be applied either prospectively or retrospectively. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.

In July 2025, the FASB issued ASU 2025-05, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets. This amendment introduces a practical expedient for the application of the current expected credit loss (CECL) model to current accounts receivable and contract assets. The

amendments will be effective for annual reporting periods beginning after December 15, 2025, and interim reporting periods within those annual reporting periods, on a prospective basis, with early adoption permitted. Based on the Company’s evaluation of this guidance, no material impact is expected on its consolidated financial statement disclosures.

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

9 Months Ended

Sep. 30, 2025

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

NOTE 9 – SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

Balance sheets:


	September 30,		December 31,
(U.S. dollars in thousands)	2025		2024
Accounts payable and accruals – other:
Payroll and related expenses	$	745	$	1,343
Provision for vacation		2,209		1,811
Accrued expenses		8,126		9,568
Royalties payable		558		1,080
Income tax payable		2,385		3,476
Payable to customer		920		2,056
Property and equipment suppliers		230		254
	$	15,173	$	19,588

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2025	Dec. 31, 2024
CURRENT ASSETS:
Cash and cash equivalents	$ 13,647	$ 19,760
Short-term bank deposits	15,723	15,070
Accounts receivable	14,425	2,909
Other assets	1,452	1,096
Inventories	21,255	21,243
Total current assets	66,502	60,078
NON-CURRENT ASSETS:
Funds in respect of employee rights upon retirement	549	462
Property and equipment, net	4,724	4,591
Deferred income tax asset	2,679	2,856
Operating lease right of use assets	7,810	5,430
Total assets	82,264	73,417
Accounts payable and accruals:
Trade	5,375	4,533
Other	15,173	19,588
Operating lease liabilities	1,397	1,500
Total current liabilities	21,945	25,621
LONG TERM LIABILITIES:
Liability for employee rights upon retirement	631	559
Operating lease liabilities	6,780	4,026
Total long term liabilities	7,411	4,585
Total liabilities	29,356	30,206
COMMITMENTS
STOCKHOLDERS' EQUITY	52,908	43,211
Total liabilities and stockholders' equity	$ 82,264	$ 73,417

EARNINGS (LOSS) PER SHARE

9 Months Ended

Sep. 30, 2025

EARNINGS (LOSS) PER SHARE

EARNINGS (LOSS) PER SHARE

NOTE 6 – EARNINGS (LOSS) PER SHARE

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


	Nine Months Ended September 30,					Three Months Ended September 30,
(In thousands, except share data)	2025		2024		2025		2024
Numerator:
Net income (loss)	$	(1,100)	$	(3,562)	$	2,355	$	3,236
Add:
Financial expenses of 2024 Notes*								(503)
Net income (loss) for diluted calculation	$	(1,100)	$	(3,562)	$	2,355	$	2,733
Denominator:
Weighted average shares of Common Stock outstanding for basic calculation		78,225,112		73,301,091		79,281,685		73,549,745
Weighted average dilutive effect of 2024 Notes								7,667,323
Weighted average dilutive effect of stock options and restricted stock						1,532,879
Weighted average shares of Common Stock outstanding for diluted calculation		78,225,112		73,301,091		80,814,564		81,217,068

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

Diluted earnings (loss) per share do not include 11,288,007 shares of Common Stock underlying outstanding stock options, unvested shares of restricted stock and warrants for the nine months ended September 30, 2025 because the effect would be anti-dilutive.

Diluted earnings (loss) per share do not include 3,745,682 shares of Common Stock underlying outstanding stock options and unvested shares of restricted stock for the three months ended September 30, 2025 because the effect would be anti-dilutive.

Diluted earnings (loss) per share do not include 30,515,287 shares of Common Stock underlying outstanding stock options, unvested shares of restricted stock, warrants and the 2024 Notes for the nine months ended September 30, 2024, and 20,173,438 shares of Common Stock underlying outstanding stock options, unvested shares of restricted stock and warrants for the three months ended September 30, 2024, because the effect would be anti-dilutive.

FAIR VALUE MEASUREMENT

9 Months Ended

Sep. 30, 2025

FAIR VALUE MEASUREMENT

FAIR VALUE MEASUREMENT

NOTE 3 – 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 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.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
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+ Details

OPERATING LEASES (Tables)

9 Months Ended

Sep. 30, 2025

OPERATING LEASES

Schedule of Operating Leases

The following table sets forth data regarding the Company’s operating leases for the three and nine months ended September 30, 2024 and 2025:


	Nine Months Ended September 30,						Three Months Ended September 30,
(U.S. dollars in thousands)	2025			2024			2025			2024
Operating lease costs	$	1,395		$	1,195		$	476		$	420
Cash paid for amounts included in the measurement of lease liabilities		1,338			1,207			457			413
Weighted average remaining lease term (in years)		22.6			6.2			22.6			6.2
Weighted average discount rate		13.4	%		12.8	%		13.4	%		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 September 30, 2025:


(U.S. dollars in thousands)	September 30, 2025
First year	$	1,397
Second year	$	1,141
Third year	$	1,074
Fourth year	$	1,040
Fifth year and thereafter	$	22,273
Total undiscounted cash flows	$	26,925
Less: imputed interest	$	18,748
Present value of operating lease liabilities	$	8,177

SIGNIFICANT ACCOUNTING POLICIES

9 Months Ended

Sep. 30, 2025

SIGNIFICANT ACCOUNTING POLICIES

SIGNIFICANT ACCOUNTING POLICIES

NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES

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)

Basis of presentation

Net earnings (loss) per share

Basic earnings (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of Common Stock outstanding for each period.

Convertible notes

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

Recently issued accounting pronouncements, not yet adopted

STOCK TRANSACTIONS (Details) $ / shares in Units, $ in Millions	3 Months Ended	9 Months Ended
	Sep. 30, 2025 USD ($) installment $ / shares shares	Sep. 30, 2025 USD ($) installment $ / shares shares	Mar. 12, 2025 shares
STOCK TRANSACTIONS
Term of award	10 years
Number of options to purchase shares	1,448,990
Vesting Period	3 years
Number of vesting installments on a quarterly basis \| installment	12	12
Aggregate fair value of the options \| $	$ 1.5
Stock price (in dollars per share) \| $ / shares	$ 1.56	$ 1.56
Exercise price (in dollars per share) \| $ / shares	$ 1.56	$ 1.56
Dividend yield (as percentage)	0.00%
Volatility (as percentage)	73.64%
Risk -free interest rate (in dollars per share)	3.90%
Expected life (Years)	5 years 9 months
Sales Agreement
STOCK TRANSACTIONS
Number of shares issued (in shares)		2,775,215
Gross stock issuance proceeds \| $		$ 7.0
Stock issuance costs \| $		$ 0.2
Private Placement
STOCK TRANSACTIONS
Number of shares issued (in shares)		908,000
Exercise of warrants \| $		$ 2.1
Warrants and rights outstanding			0
Restricted Stock
STOCK TRANSACTIONS
Vesting Period	3 years
Number of vesting installments on a quarterly basis \| installment	12	12
Granted (in shares)	559,210
Vested (in shares)	52,910
Aggregate fair value of the restricted stock \| $	$ 0.9
Restricted Stock \| Share Based Compensation Award Tranche One
STOCK TRANSACTIONS
Stock price (in dollars per share) \| $ / shares	$ 1.64	$ 1.64
Restricted Stock \| Share Based Compensation Award Tranche Two
STOCK TRANSACTIONS
Stock price (in dollars per share) \| $ / shares	$ 1.89	$ 1.89
Options
STOCK TRANSACTIONS
Exercise of options		248,625
Cash proceeds from stock options exercised \| $		$ 0.2

INVENTORIES (Tables)

9 Months Ended

Sep. 30, 2025

INVENTORIES

Schedule of Inventory

Inventories at September 30, 2025 and December 31, 2024 consisted of the following:


	September 30,		December 31,
(U.S. dollars in thousands)	2025		2024
Raw materials	$	4,983	$	4,549
Work in progress		5,355		11,245
Finished goods		10,917		5,449
Total inventory	$	21,255	$	21,243

SUBSEQUENT EVENTS (Details) - USD ($)	1 Months Ended	9 Months Ended
SUBSEQUENT EVENTS (Details) - USD ($)	Nov. 13, 2025	Sep. 30, 2025
Options
SUBSEQUENT EVENTS
Exercise of options		248,625
Cash proceeds from stock options exercised		$ 200,000
Subsequent Event
SUBSEQUENT EVENTS
Exercise of options	79,856
Cash proceeds from stock options exercised	$ 94,200
Subsequent Event \| Pfizer
SUBSEQUENT EVENTS
Total proceeds from sale of products	1,400,000
Subsequent Event \| Fiocruz (Brazil)
SUBSEQUENT EVENTS
Total proceeds from sale of products	3,000,000
Subsequent Event \| Chiesi Agreements
SUBSEQUENT EVENTS
Total proceeds from sale of products	$ 9,900,000

SEGMENT INFORMATION (Schedule of Disaggregation of Revenues) (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024	Sep. 30, 2025	Sep. 30, 2024
SEGMENT INFORMATION
TOTAL REVENUE	$ 17,851	$ 17,959	$ 43,622	$ 35,181
GOODS
SEGMENT INFORMATION
TOTAL REVENUE	17,673	17,839	43,108	34,820
LICENSE AND R&D SERVICES
SEGMENT INFORMATION
TOTAL REVENUE	178	120	514	361
Pfizer \| GOODS
SEGMENT INFORMATION
TOTAL REVENUE	2,805	3,430	15,431	11,431
Fiocruz \| GOODS
SEGMENT INFORMATION
TOTAL REVENUE	6,105	2,048	9,121	9,314
Chiesi \| GOODS
SEGMENT INFORMATION
TOTAL REVENUE	$ 8,763	$ 12,361	$ 18,556	$ 14,075

- 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

TAXES ON INCOME (TAX BENEFIT) (Additional Information) (Details)	9 Months Ended
	Sep. 30, 2025	Sep. 30, 2024
TAXES ON INCOME (TAX BENEFIT)
Effective income tax rate (as a percent)	(32.00%)	(13.00%)
Statutory income tax rate	21.00%