0001104659-26-059756 | 10-Q | XBRL Viewer | Protalix Biotherapeutics INC

FAIR VALUE MEASUREMENT	3 Months Ended
Mar. 31, 2026
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.

FAIR VALUE MEASUREMENT

3 Months Ended

Mar. 31, 2026

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.

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+ Details

INVENTORIES

3 Months Ended

Mar. 31, 2026

INVENTORIES

INVENTORIES

NOTE 2 - INVENTORIES

Inventories at March 31, 2026 and December 31, 2025 consisted of the following:


		March 31,			December 31,
(U.S. dollars in thousands)		2026			2025
Raw materials		$	6,007		$	5,980
Work in progress			9,083			9,375
Finished goods			15,384			10,374
Total inventory		$	30,474		$	25,729

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

3 Months Ended

Mar. 31, 2026

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

NOTE 8 – SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

Balance sheets:


		March 31,			December 31,
(U.S. dollars in thousands)		2026			2025
Accounts payable and accruals – other:
Payroll and related expenses		$	3,706		$	1,629
Provision for vacation			2,448			2,309
Accrued expenses			9,685			9,790
Royalties payable			973			799
Income tax payable			3,203			2,950
Payable to customer			1,369			2,029
Property and equipment suppliers			286			369
		$	21,670		$	19,875

Statements of Operations:


(U.S. dollars in thousands)		Three Months Ended March 31,
Research and development expenses:		2026			2025
Employee salaries and related expenses		$	2,762		$	1,894
Subcontractor-related expenses			1,435			805
Materials-related expenses			417			216
Depreciation			132			114
Other expenses			680			446
		$	5,426		$	3,475

STOCK TRANSACTIONS (Details) - Options $ in Millions	3 Months Ended
STOCK TRANSACTIONS (Details) - Options $ in Millions	Mar. 31, 2026 USD ($) shares
STOCK TRANSACTIONS
Exercise of options \| shares	145,661
Cash proceeds from stock options exercised \| $	$ 0.2

- Definition

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

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+ Details

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Accounts Payable and Accruals - Other) (Details) - USD ($) $ in Thousands	Mar. 31, 2026	Dec. 31, 2025
Accounts payable and accruals - other:
Payroll and related expenses	$ 3,706	$ 1,629
Provision for vacation	2,448	2,309
Accrued expenses	9,685	9,790
Royalties payable	973	799
Income tax payable	3,203	2,950
Payable to customer	1,369	2,029
Property and equipment suppliers	286	369
Accounts payable and accruals - other	$ 21,670	$ 19,875

STOCK TRANSACTIONS	3 Months Ended
Mar. 31, 2026
STOCK TRANSACTIONS
STOCK TRANSACTIONS	NOTE 4 – STOCK TRANSACTIONS During the three months ended March 31, 2026, the Company issued, in the aggregate, 145,661 shares of Common Stock in connection with the exercise of options to purchase 145,661 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.

STOCK TRANSACTIONS

3 Months Ended

Mar. 31, 2026

STOCK TRANSACTIONS

STOCK TRANSACTIONS

NOTE 4 – STOCK TRANSACTIONS

During the three months ended March 31, 2026, the Company issued, in the aggregate, 145,661 shares of Common Stock in connection with the exercise of options to purchase 145,661 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.

- Definition

The entire disclosure for equity.

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+ Details

SEGMENT INFORMATION (Schedule of Disaggregation of Revenues) (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
SEGMENT INFORMATION
TOTAL REVENUE	$ 33,750	$ 10,113
GOODS
SEGMENT INFORMATION
TOTAL REVENUE	7,419	9,995
LICENSE AND R&D SERVICES
SEGMENT INFORMATION
TOTAL REVENUE	26,331	118
Pfizer \| GOODS
SEGMENT INFORMATION
TOTAL REVENUE	1,452	6,979
Fiocruz \| GOODS
SEGMENT INFORMATION
TOTAL REVENUE	2,454	$ 3,016
Chiesi \| GOODS
SEGMENT INFORMATION
TOTAL REVENUE	$ 3,513

- 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

INVENTORIES (Schedule of Inventory) (Details) - USD ($) $ in Thousands	Mar. 31, 2026	Dec. 31, 2025
INVENTORIES
Raw materials	$ 6,007	$ 5,980
Work in progress	9,083	9,375
Finished goods	15,384	10,374
Total inventory	$ 30,474	$ 25,729

SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2026

SIGNIFICANT ACCOUNTING POLICIES

General

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

The Company’s commercial product portfolio consists of two enzyme replacement therapies (ERTs):

●

Elelyso^® (taliglucerase alfa) for the treatment of adult patients and children four years of age and older with Gaucher disease. This product is approved in the United States, Brazil, and Israel, as well as many other jurisdictions.

●

Elfabrio^® (pegunigalsidase alfa) for the treatment of adult patients with a confirmed diagnosis of Fabry disease. This product is approved in the United States, the European Union, and other jurisdictions with a 1 mg/kg every-two-weeks (E2W) dosage. In March 2026, Elfabrio was approved for a 2 mg/kg every-four-weeks (E4W) dosage in the European Union.

In addition, the Company’s product pipeline currently includes, among other candidates:

●

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

●

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

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

Consistent with its strategy, the Company continuously evaluates potential strategic marketing partnerships as well as collaboration programs with biotechnology and pharmaceutical companies and academic research institutions.

Because the Company’s operations are conducted in the State of Israel, the Company’s business and operations face risks related to the military, economic, political, and geopolitical conditions in Israel. Since October 2023, Israel has suffered from missile and other similar attacks and has been engaged in military activity on a number of fronts, including with the Hamas and other terrorist groups in the Gaza Strip, with Hezbollah in Lebanon, in Iran, with the Houthis terrorist group that controls parts of Yemen, and others, and both civilian and military targets in Israel have been attacked. In June 2025 and again in February 2026, Israel and the United States conducted strikes against Iranian military and nuclear infrastructure, both of which involved Iranian counterattacks as well as Hezbollah attacks on Israel. Ceasefires have been declared in connection with all of these military actions. Despite the ceasefires, the situation remains volatile, with the potential for renewed escalation involving Iran or other terrorist organizations. 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. It is currently not possible to predict whether or not such ceasefires will be maintained, or the duration or severity of the above conflicts or the effects of such conflicts, or any of them, on the Company’s operations. As of the issuance of these financial statements, the impacts of the military actions described above have not had a material adverse effect on the Company’s business, results of operations, and financial condition.

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 March 31, 2026 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, 2025, filed by the Company with the U.S. Securities and Exchange Commission (the “Commission”) on March 18, 2026. The comparative balance sheet at December 31, 2025 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, 2025.

Net earnings (loss) per share

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

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; and (ii) the exercise of warrants using the treasury stock method.

New accounting pronouncements

New accounting pronouncements

Recently issued accounting pronouncements, not yet adopted

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

In December 2025, the FASB issued ASU 2025-10 “Government Grants (Topic 832)” to establish authoritative guidance on the accounting for government grants received by business entities. This update is effective beginning with the

Company’s 2029 fiscal year annual reporting period, with early adoption permitted. The Company is currently evaluating the impact that the adoption of this standard will have on its consolidated financial statements.

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

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Mar. 31, 2026
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

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2026	May 01, 2026
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2026
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		80,571,642
Entity Central Index Key	0001006281
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2026
Document Fiscal Period Focus	Q1
Amendment Flag	false

EARNINGS (LOSS) PER SHARE (Tables)

3 Months Ended

Mar. 31, 2026

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:


			Three Months Ended March 31,
(In thousands, except share data)		2026			2025
Numerator:
Net income (loss) for diluted calculation		$	18,317		$	(3,619)
Denominator:
Weighted average shares of Common Stock outstanding for basic calculation			79,848,892			76,611,980
Weighted average dilutive effect of stock options and unvested restricted stock			3,199,704
Weighted average shares of Common Stock outstanding for diluted calculation			83,048,596			76,611,980

SIGNIFICANT ACCOUNTING POLICIES (Additional Information) (Details) - $ / shares	Mar. 31, 2026	Dec. 31, 2025
SIGNIFICANT ACCOUNTING POLICIES
Common Stock, Par or Stated Value Per Share (in dollars per share)	$ 0.001	$ 0.001

TAXES ON INCOME (TAX BENEFIT) (Tables)

3 Months Ended

Mar. 31, 2026

TAXES ON INCOME (TAX BENEFIT)

Schedule of Taxes on Income

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


	Three Months Ended March 31,
(U.S. dollars in thousands)	2026		2025
Current taxes on income - US (federal)	$	2,753	$
Deferred taxes on income - US (federal)	$	71	$	(113)
Total taxes on income	$	2,824	$	(113)

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Research and Development Expenses) (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Research And Development Expenses [Line Items]
Depreciation	$ 404	$ 346
Research and Development Expense, Total	5,426	3,475
Research and development expenses
Research And Development Expenses [Line Items]
Employee salaries and related expenses	2,762	1,894
Sub-contractors expense	1,435	805
Materials-related expenses	417	216
Depreciation	132	114
Other expenses	680	446
Research and Development Expense, Total	$ 5,426	$ 3,475

TAXES ON INCOME (TAX BENEFIT)

3 Months Ended

Mar. 31, 2026

TAXES ON INCOME (TAX BENEFIT)

TAXES ON INCOME (TAX BENEFIT)

NOTE 6 – TAXES ON INCOME (TAX BENEFIT)

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


	Three Months Ended March 31,
(U.S. dollars in thousands)	2026		2025
Current taxes on income - US (federal)	$	2,753	$
Deferred taxes on income - US (federal)	$	71	$	(113)
Total taxes on income	$	2,824	$	(113)

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

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2026	Dec. 31, 2025
CURRENT ASSETS:
Cash and cash equivalents	$ 41,001	$ 14,680
Short-term bank deposits	10,082	15,593
Restricted deposit	711	702
Accounts receivable	2,939	8,840
Other assets	1,149	1,129
Inventories	30,474	25,729
Total current assets	86,356	66,673
NON-CURRENT ASSETS:
Funds in respect of employee rights upon retirement	589	578
Property and equipment, net	5,153	4,879
Deferred income tax asset	2,445	2,516
Operating lease right of use assets	7,793	7,700
Total assets	102,336	82,346
Accounts payable and accruals:
Trade	4,285	5,259
Other	21,670	19,875
Operating lease liabilities	1,433	1,384
Total current liabilities	27,388	26,518
LONG TERM LIABILITIES:
Liability for employee rights upon retirement	671	661
Operating lease liabilities	7,048	6,937
Total long-term liabilities	7,719	7,598
Total liabilities	35,107	34,116
COMMITMENTS
STOCKHOLDERS' EQUITY	67,229	48,230
Total liabilities and stockholders' equity	$ 102,336	$ 82,346

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

Common Stock

Additional Paid-in Capital

Accumulated Deficit

Total

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

$ 1

2,860

2,861

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

^[1]

1,325,179

Share-based compensation related to stock options

336

Share-based compensation related to restricted stock awards

204

Exercise of warrants and options

$ 1

2,214

2,215

Exercise of warrants and options (in shares)

^[1]

958,375

Net Income (Loss)

(3,619)

Ending balance at Mar. 31, 2025

$ 78

427,142

(382,012)

45,208

Ending balance (in shares) at Mar. 31, 2025

^[1]

78,133,829

Beginning balance at Dec. 31, 2025

$ 80

433,147

(384,997)

48,230

Beginning balance (in shares) at Dec. 31, 2025

^[1]

80,425,981

Share-based compensation related to stock options

362

Share-based compensation related to restricted stock awards

170

Exercise of warrants and options

$ 1

149

150

Exercise of warrants and options (in shares)

^[1]

145,661

Net Income (Loss)

18,317

Ending balance at Mar. 31, 2026

$ 81

$ 433,828

$ (366,680)

$ 67,229

Ending balance (in shares) at Mar. 31, 2026

^[1]

80,571,642

[1]	Common stock, $0.001 par value; Authorized – as of March 31, 2026 and December 31, 2025 – 185,000,000 shares.

- 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

- Definition

Equity impact of the value of new stock issued during the period. Includes shares issued in an initial public offering or a secondary public offering.

+ References + Details

- Definition

Amount of equity (deficit) attributable to parent. Excludes temporary equity and equity attributable to noncontrolling interest.

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+ Details

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Mar. 31, 2026	Mar. 31, 2025
Pay vs Performance Disclosure
Net Income (Loss)	$ 18,317	$ (3,619)

- Definition

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

+ References

+ Details

SEGMENT INFORMATION

3 Months Ended

Mar. 31, 2026

SEGMENT INFORMATION

SEGMENT INFORMATION

NOTE 7 – 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 based on net income (losses).

Segment information:


	Three Months Ended March 31,
(U.S. dollars in thousands)	2026		2025
Revenues from customers	$	33,750	$	10,113
Less:
Employee salaries and related expenses		6,697		5,205
Sub-contractors expense		4,441		2,689
Interest expense		-		6
Interest income		(188)		(419)
Depreciation		404		346
Other segment expenses*		1,255		6,018
Income (loss) before taxes on income		21,141		(3,732)
Taxes on income (tax benefit)		2,824		(113)
Segment net income (loss)	$	18,317	$	(3,619)

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

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


	Three Months Ended March 31,
(U.S. dollars in thousands)	2026		2025
Gaucher disease:
Pfizer (Ireland)	$	1,452	$	6,979
Fiocruz (Brazil)	$	2,454	$	3,016
Fabry disease:
Chiesi (Italy)	$	3,513	$	-
Total revenues from selling goods	$	7,419	$	9,995
Revenues from license and R&D services	$	26,331	$	118

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

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Tables)

3 Months Ended

Mar. 31, 2026

SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION

Schedule of Supplemental Information of Balance Sheets


		March 31,			December 31,
(U.S. dollars in thousands)		2026			2025
Accounts payable and accruals – other:
Payroll and related expenses		$	3,706		$	1,629
Provision for vacation			2,448			2,309
Accrued expenses			9,685			9,790
Royalties payable			973			799
Income tax payable			3,203			2,950
Payable to customer			1,369			2,029
Property and equipment suppliers			286			369
		$	21,670		$	19,875

Schedule of Supplemental Statements of operations


(U.S. dollars in thousands)		Three Months Ended March 31,
Research and development expenses:		2026			2025
Employee salaries and related expenses		$	2,762		$	1,894
Subcontractor-related expenses			1,435			805
Materials-related expenses			417			216
Depreciation			132			114
Other expenses			680			446
		$	5,426		$	3,475

EARNINGS (LOSS) PER SHARE

3 Months Ended

Mar. 31, 2026

EARNINGS (LOSS) PER SHARE

EARNINGS (LOSS) PER SHARE

NOTE 5 – EARNINGS (LOSS) PER SHARE

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


			Three Months Ended March 31,
(In thousands, except share data)		2026			2025
Numerator:
Net income (loss) for diluted calculation		$	18,317		$	(3,619)
Denominator:
Weighted average shares of Common Stock outstanding for basic calculation			79,848,892			76,611,980
Weighted average dilutive effect of stock options and unvested restricted stock			3,199,704
Weighted average shares of Common Stock outstanding for diluted calculation			83,048,596			76,611,980

Diluted earnings per share do not include 1,340,697 shares of Common Stock underlying outstanding stock options, unvested shares of restricted stock for the three months ended March 31, 2026 because the effect would be anti-dilutive.

Diluted loss per share do not include 18,216,366 shares of Common Stock underlying outstanding stock options, unvested shares of restricted stock and warrants for the three months ended March 31, 2025 because the effect would be anti-dilutive.

SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2026

SIGNIFICANT ACCOUNTING POLICIES

SIGNIFICANT ACCOUNTING POLICIES

NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES

General

The Company’s commercial product portfolio consists of two enzyme replacement therapies (ERTs):

●

In addition, the Company’s product pipeline currently includes, among other candidates:

●

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

●

Basis of presentation

Net earnings (loss) per share

New accounting pronouncements

Recently issued accounting pronouncements, not yet adopted

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)	$ 18,317	$ (3,619)
Adjustments required to reconcile net income (loss) to net cash provided by (used in) operating activities:
Share-based compensation	532	540
Depreciation	404	346
Financial (income) expenses, net	158	(375)
Changes in accrued liability for employee rights upon retirement	5	3
Changes in deferred income tax asset	71	(113)
Changes in operating assets and liabilities:
Decrease (increase) in accounts receivable-trade and other assets	6,408	(2,275)
Changes in operating lease right of use assets, net	55	(18)
Decrease (increase) in inventories	(4,745)	1,737
Increase (decrease) in accounts payable and accruals	820	(1,284)
Net cash provided by (used in) operating activities	22,025	(5,058)
CASH FLOWS FROM INVESTING ACTIVITIES:
Investment in bank deposits	(5,000)
Short-term deposit withdrawal	10,000
Purchase of property and equipment	(761)	(306)
Amounts funded in respect of employee rights upon retirement, net	(7)	(6)
Increase in restricted deposit	(9)
Net cash provided by (used in) investing activities	4,223	(312)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock under the Sales Agreement, net		2,861
Exercise of warrants and options	150	2,215
Net cash provided by financing activities	150	5,076
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS	(77)	(8)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	26,321	(302)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD	14,680	19,760
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD	41,001	19,458
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
Purchase of property and equipment	286	427
Operating lease right of use assets obtained in exchange for new operating lease liabilities	284	33
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS
Tax paid	2,500
Interest received	$ 688	$ 166

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
TOTAL REVENUE	$ 33,750	$ 10,113
COST OF REVENUES	(4,127)	(8,180)
RESEARCH AND DEVELOPMENT EXPENSES	(5,426)	(3,475)
SELLING, GENERAL, AND ADMINISTRATIVE EXPENSES	(3,051)	(2,603)
OPERATING INCOME (LOSS)	21,146	(4,145)
FINANCIAL EXPENSES	(193)	(6)
FINANCIAL INCOME	188	419
FINANCIAL INCOME (EXPENSES), NET	(5)	413
INCOME (LOSS) BEFORE TAXES ON INCOME	21,141	(3,732)
TAXES ON INCOME (TAX BENEFIT)	(2,824)	113
NET INCOME (LOSS)	$ 18,317	$ (3,619)
EARNINGS (LOSS) PER SHARE OF COMMON STOCK - BASIC (in dollars per share)	$ 0.23	$ (0.05)
EARNINGS (LOSS) PER SHARE OF COMMON STOCK - DILUTED (in dollars per share)	$ 0.22	$ (0.05)
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING EARNINGS (LOSS) PER SHARE - BASIC (in shares)	79,848,892	76,611,980
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING EARNINGS (LOSS) PER SHARE - DILUTED (in shares)	83,048,596	76,611,980
Goods
TOTAL REVENUE	$ 7,419	$ 9,995
License and R&D Services
TOTAL REVENUE	$ 26,331	$ 118

SEGMENT INFORMATION (Schedule of Segment Information) (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2026 USD ($) segment	Mar. 31, 2025 USD ($)
SEGMENT INFORMATION
Number of Operating Segments \| segment	1
Number of reportable segments \| segment	1
Revenues from customers	$ 33,750	$ 10,113
Depreciation	404	346
INCOME (LOSS) BEFORE TAXES ON INCOME	21,141	(3,732)
Taxes on income (tax benefit)	2,824	(113)
NET INCOME (LOSS)	$ 18,317	$ (3,619)
Segment reporting description	Other expenses included in net income include raw materials, rent and utilities, and others.	Other expenses included in net income include raw materials, rent and utilities, and others.
Single reporting segment
SEGMENT INFORMATION
Revenues from customers	$ 33,750	$ 10,113
Employee salaries and related expenses	6,697	5,205
Sub-contractors expense	4,441	2,689
Interest expense		6
Interest income	(188)	(419)
Depreciation	404	346
Other segment expenses	1,255	6,018
INCOME (LOSS) BEFORE TAXES ON INCOME	21,141	(3,732)
Taxes on income (tax benefit)	2,824	(113)
NET INCOME (LOSS)	$ 18,317	$ (3,619)

EARNINGS (LOSS) PER SHARE (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
Numerator:
Net income (loss) for diluted calculation	$ 18,317	$ (3,619)
Denominator:
Weighted average shares of Common Stock outstanding for basic calculation	79,848,892	76,611,980
Weighted average dilutive effect of stock options and unvested restricted stock	3,199,704
Weighted average shares of Common Stock outstanding for diluted calculation	83,048,596	76,611,980
Outstanding Stock Options and Unvested Restricted Stock
Denominator:
Antidilutive securities excluded from computation of earnings (loss) per share, amount	1,340,697
Outstanding Stock Options, Unvested Restricted Stock and Warrants
Denominator:
Antidilutive securities excluded from computation of earnings (loss) per share, amount		18,216,366

- Definition

Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities, and addition from assumption of issuance of common shares for dilutive potential common shares; of income (loss) available to common shareholders.

+ References + Details

INVENTORIES (Tables)

3 Months Ended

Mar. 31, 2026

INVENTORIES

Schedule of Inventory

Inventories at March 31, 2026 and December 31, 2025 consisted of the following:


		March 31,			December 31,
(U.S. dollars in thousands)		2026			2025
Raw materials		$	6,007		$	5,980
Work in progress			9,083			9,375
Finished goods			15,384			10,374
Total inventory		$	30,474		$	25,729

TAXES ON INCOME (TAX BENEFIT) (Summary of Taxes on Income) (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2026	Mar. 31, 2025
TAXES ON INCOME (TAX BENEFIT)
Current taxes on income - US (federal)	$ 2,753
Deferred taxes on income - US (federal)	71	$ (113)
Total taxes on income	$ 2,824	$ (113)

- Definition

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

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+ Details

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Parenthetical) - $ / shares	Mar. 31, 2026	Dec. 31, 2025
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

SEGMENT INFORMATION (Tables)

3 Months Ended

Mar. 31, 2026

SEGMENT INFORMATION

Schedule of Segment Information

Segment information:


	Three Months Ended March 31,
(U.S. dollars in thousands)	2026		2025
Revenues from customers	$	33,750	$	10,113
Less:
Employee salaries and related expenses		6,697		5,205
Sub-contractors expense		4,441		2,689
Interest expense		-		6
Interest income		(188)		(419)
Depreciation		404		346
Other segment expenses*		1,255		6,018
Income (loss) before taxes on income		21,141		(3,732)
Taxes on income (tax benefit)		2,824		(113)
Segment net income (loss)	$	18,317	$	(3,619)

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

Schedule of Disaggregation of Revenues

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


	Three Months Ended March 31,
(U.S. dollars in thousands)	2026		2025
Gaucher disease:
Pfizer (Ireland)	$	1,452	$	6,979
Fiocruz (Brazil)	$	2,454	$	3,016
Fabry disease:
Chiesi (Italy)	$	3,513	$	-
Total revenues from selling goods	$	7,419	$	9,995
Revenues from license and R&D services	$	26,331	$	118