Protalix BioTherapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
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Sep 30, 2026 · Filed Nov 10, 2026
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Notes to Condensed Consolidated Financial Statements
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
| a. | 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. Subsequently, the E4W dosage was approved in the UK and other jurisdictions. |
On March 31, 2026, following the approval of the E4W dosing regimen for Elfabrio in the EU, the Company received a $25.0 million milestone payment from its commercialization partner for Elfabrio, Chiesi Farmaceutici S.p.A. (“Chiesi”).
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). |
PRX-115 is currently the subject of a Phase 2 clinical trial for the potential treatment of uncontrolled gout (the “RELEASE study”).
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.
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 addition, Israel and the U.S. have conducted strikes against Iranian military and nuclear infrastructure which involved Iranian counterattacks as well as Hezbollah attacks on Israel. These situations remain volatile, with the potential for escalation at
any time. 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 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 development efforts with respect to its product candidates. The Company believes that its cash and cash equivalents and short-term bank deposits are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued.
| b. | Basis of presentation |
The 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.
| c. | 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, 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, non-vested restricted stock, and non-vested restricted stock units granted under employee stock compensation plans using the treasury stock method; and (ii) the exercise of warrants using the treasury stock method.
| d. | 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.
NOTE 2 - INVENTORIES
Inventories at September 30, 2026 and December 31, 2025 consisted of the following:
| · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · September 30, · · December 31, · | ||||||
| (U.S. dollars in thousands) · · 2026 · · 2025 · | ||||||
| Raw materials | | $6,396 | | $5,980 | | |
| Work in progress | | 7,093 | | | 9,375 | |
| Finished goods | | 20,808 | | | 10,374 | |
| Total inventory | | $34,297 | | $25,729 | | |
NOTE 3 – LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT
Prior to the three months ended June 30, 2026, Protalix Ltd., the Company’s Israeli subsidiary, was required in certain circumstances to make a severance payment upon retirement of certain employees. The Company recorded the liability resulting from this obligation on its balance sheets under “Liability for employee rights upon retirement.” The Company funded this liability, in part, through the purchase of insurance policies or by the establishment of pension funds, and the amounts so funded were recorded in the Company’s balance sheets under “Funds in respect of employee rights upon retirement.” Prior to June 30, 2026, the Company amended its agreements with the relevant employees to be consistent with the Company’s agreements with the remainder of its employees. Giving effect to such amendments, the Company makes deposits to certain insurance companies or pension funds for accounts controlled by each applicable employee in order to secure the employee’s rights upon retirement in lieu of severance. Accordingly, the Company no longer has any remaining funds or liabilities for employee rights upon retirement recognized in its balance sheet and has no subsequent liabilities for severance. The liability accrued and the amounts funded are not recorded in the Company’s balance sheets as the amounts funded are not under the Company’s control or management, and the liability has been irrevocably transferred to the applicable insurance companies or pension funds.
NOTE 4 – 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.
NOTE 5 – STOCK TRANSACTIONS
| a. | During the nine months ended September 30, 2026, the Company issued, in the aggregate, 453,296 shares of common stock in connection with the exercise of options to purchase 453,296 shares of common stock by certain current and former employees of the Company. The Company received cash proceeds equal to $0.5 million in connection with such exercises. |
| b. | During the three months ended September 30, 2026, the Company sold, in the aggregate, 1,613,992 shares of common stock under that certain At The Market Offering Agreement dated February 27, 2023 and amended on March 17, 2025 (as may be amended from time to time, the “Sales Agreement”) between the Company and H.C. Wainwright & Co., LLC, as the Company’s sales agent (the “Agent”). The Company generated gross proceeds equal to approximately $4.3 million in connection with such sales (issuance costs were $0.1 million). |
| c. | During the three months ended September 30, 2026, the Company granted, with the approval of the Company’s Board of Directors, 10-year options to purchase 1,317,750 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 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 date of grant using the Black-Scholes option-pricing model to be approximately $2.2 million using the following assumptions (weighted average): stock price equal to $2.59, exercise price equal to $2.59, dividend yield of 0%, expected volatility of 71%, risk-free interest rate of 4.6% and expected life in years, 5.75. |
| d. | During the three months ended September 30, 2026, the Company granted, with the approval of the Company’s Board of Directors, 702,925 restricted stock units (“RSUs”), in the aggregate, to certain of the Company’s officers, directors, and other employees under the Plan. The RSUs generally vest over a three-year period in 12 equal quarterly increments. Vesting of RSUs 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 RSUs on the date of grant to be approximately $1.8 million, based on the closing price of the common stock on the date of grant. |
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) · · 2026 · · 2025 · · 2026 · · 2025 | ||||||||||||
| Numerator: | | | | | | | | | | | | |
| Net income (loss) for basic and diluted calculation | | $26,055 | | $(1,100) | | $3,961 | | $2,355 | ||||
| Denominator: | | | | | | | | | | | | |
| Weighted average shares of common stock outstanding for basic calculation | | | 80,077,803 | | | 78,225,112 | | | 80,455,731 | | | 79,281,685 |
| Weighted average dilutive effect of stock options and unvested restricted stock | | | 2,923,180 | | | | | | 3,131,043 | | | 1,532,879 |
| Weighted average shares of common stock outstanding for diluted calculation | | | 83,000,983 | | | 78,225,112 | | | 83,586,774 | | | 80,814,564 |
Diluted earnings per share do not include 1,765,721 and 2,088,077 shares of common stock underlying outstanding stock options and restricted stock units for the nine and three months ended September 30, 2026, respectively, because the effect would be anti-dilutive.
Diluted earnings (loss) per share does 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, and 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.
NOTE 7 – TAXES ON INCOME
| a. | 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) · · 2026 · · 2025 · · 2026 · · 2025 | ||||||||||
| Current taxes on income - U.S. (federal) | | $4,356 | | $91 | | $590 | | $(175) | ||
| Deferred taxes on income - U.S. (federal) | | | 212 | | | 177 | | $71 | | $59 |
| Total taxes on income | | $4,568 | | $268 | | $661 | | $(116) | ||
On July 4, 2025, tax reform legislation was enacted in the United States through the passage of H.R.1, The One Big Beautiful Bill Act, 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.
| b. | On March 31, 2026, the Israeli Knesset enacted the “Law for the Encouragement and Incentivization of Research and Development, 2026” (the “R&D Law”). The R&D Law introduces a refundable tax credit regime calculated as a percentage of qualifying research and development expenditures incurred in Israel (with respect to clinical trials, expenses incurred outside of Israel may, under certain conditions, also qualify), effective from tax year 2026. Subject to certain conditions, eligible companies may apply the credit against Israeli income tax liabilities or the Israeli qualified domestic minimum top-up tax, or, alternatively, to receive a government grant if the credit is not utilized or if the eligible company chooses irrevocably to receive a grant instead of the credit. |
The R&D Law requires income from a “Preferred Enterprise” or a “Preferred Technological Enterprise” in order to be eligible for the tax credit, and does not include reference to the historic “Approved Enterprise” track.
Following analysis, and after considering, inter alia, (i) the existing tax regime in Israel, including the benefits described above, (ii) the Company’s existing net operating loss carryforwards (“NOLs”), (iii) the ability to apply for additional governmental grants for capital investments, (iv) the short-, medium- and long-term benefits as compared with the longer-term benefit available under the Company’s current structure, and (v) the 7.5% flat tax rate applicable to “Preferred Technological Income” of a “Preferred Technological Enterprise” (“PTE”), the Company elected to waive its “Approved Enterprise” status and to have the Lawfor the Encouragement of Capital Investments, 1959, as amended, apply to it under the PTE benefit track. As a result, the Company is eligible to, and intends to, file for grants under the R&D Law (as noted above, the R&D Law includes an option pursuant to which a qualifying company entitled to a tax credit that has not utilized such credit by the tax year ending three years following the year in which the related R&D activity was performed, or if the Company chooses irrevocably, to receive the full amount of the unused credit as a grant payment instead of the credit).
Government grants and refundable tax credits, such as those provided under the recently enacted R&D Law, are recognized as a reduction of the related expense when there is reasonable assurance that the Company will comply with the required conditions and that the incentive will be received. The R&D grant asset is recognized on a discounted basis. For the nine and three months ended September 30, 2026, the Company recorded$3.1 million and$1.0 million, respectively, as a reduction of research and development expenses.
| c. | On April 2, 2026, the President of the United States issued Proclamation 11020 under Section 232 of the U.S. Trade Expansion Act of 1962 imposing tariffs on imports of certain patented pharmaceutical products and their active pharmaceutical ingredients, including their key starting materials. The tariffs took effect on September 29, 2026 for products of companies that are not listed in Annex III to Proclamation 11020. Different rates apply to patented pharmaceutical products and associated ingredients from certain jurisdictions, from companies with U.S. Department of Commerce-approved onshoring agreements, and from companies with “most-favored-nation” pricing agreements with the U.S. Department of Health and Human Services. There are also exceptions for certain specialty drugs and products imported solely for clinical trials or research and development. The Company is actively pursuing measures to mitigate or eliminate the adverse effect of the applicable tariffs. Increased tariffs may impact the Company’s ability to commercialize its current and future products under development in the U.S. The extent of the impact that such tariffs will have on the Company specifically, or on the U.S. market and global economy generally, is uncertain and unpredictable, and could have a material adverse effect on the Company’s business, results of operations, and financial condition. |
NOTE 8 –SEGMENT INFORMATION
| a. | 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). |
| b. | Segment information: |
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Nine Months Ended September 30, · · Three Months Ended September 30, | ||||||||||||
| (U.S. dollars in thousands) · · 2026 · · 2025 · · 2026 · · 2025 | ||||||||||||
| Revenues from customers | | $75,571 | | $43,622 | | $21,925 | | $17,851 | ||||
| Less: | | | | | | | | | | | | |
| Employee salaries and related expenses | | | 21,738 | | | 16,502 | | | 7,386 | | | 5,853 |
| Sub-contractors expense | | | 14,443 | | | 9,348 | | | 6,103 | | | 1,886 |
| Interest expense | | | - | | | - | | | - | | | - |
| Interest income | | | (911) | | | (818) | | | (366) | | | (288) |
| Depreciation | | | 1,231 | | | 1,078 | | | 424 | | | 372 |
| R&D grant | | | (3,089) | | | | | | (989) | | | |
| Other segment expenses, net* | | | 11,536 | | | 18,344 | | | 4,745 | | | 7,789 |
| Income (loss) before taxes on income | | | 30,623 | | | (832) | | | 4,622 | | | 2,239 |
| Taxes on income (tax benefit) | | | 4,568 | | | 268 | | | 661 | | | (116) |
| Segment net income (loss) | | $26,055 | | $(1,100) | | $3,961 | | $2,355 | ||||
*Other expenses included in net income include raw materials, rent, and utilities, and others.
| c. | 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) · 2026 · · 2025 · · 2026 · · 2025 · | ||||||||||||
| Gaucher disease: · · · · · · · · · · · | ||||||||||||
| Pfizer (Ireland) | $10,062 | | $15,431 | | $4,331 | | $2,805 | | ||||
| Fiocruz (Brazil) | $8,333 | | $9,121 | | $4,365 | | $6,105 | | ||||
| Fabry disease: | | | | | | | | | | | | |
| Chiesi (Italy) | $30,686 | | $18,556 | | $13,138 | | $8,763 | | ||||
| Total revenues from selling goods | $49,081 | | $43,108 | | $21,834 | | $17,673 | | ||||
| Revenues from license and R&D services | $26,490 | | $514 | | $91 | | $178 | | ||||
| d. | Long lived assets are located in Israel. |
NOTE 9 –SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION
| a. | Balance sheets: |
| | | | | | | |
|---|---|---|---|---|---|---|
| · · September 30, · · December 31, | ||||||
| (U.S. dollars in thousands) · · 2026 · · 2025 | ||||||
| Accounts payable and accruals – other: | | | | | | |
| Payroll and related expenses | | $2,044 | | $1,629 | ||
| Provision for vacation | | | 2,699 | | | 2,309 |
| Accrued expenses | | | 12,004 | | | 9,790 |
| Royalties payable | | | 655 | | | 799 |
| Income tax payable | | | 2,936 | | | 2,950 |
| Payable to customer | | | 3,032 | | | 2,029 |
| Property and equipment suppliers | | 399 | | | 369 | |
| | | $23,769 | | $19,875 | ||
| b. | Statements of Operations: |
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (U.S. dollars in thousands) · · Nine Months Ended September 30, · · Three Months Ended September 30, | ||||||||||||
| Research and development expenses: · · 2026 · · 2025 · 2026 · · 2025 | ||||||||||||
| Employee salaries and related expenses | | $8,872 | | $6,528 | | $3,049 | | $2,588 | ||||
| Subcontractor-related expenses | | | 7,363 | | | 4,316 | | | 3,788 | | | 504 |
| Materials-related expenses | | | 1,147 | | | 880 | | | 414 | | | 454 |
| Depreciation | | | 402 | | | 388 | | | 138 | | | 157 |
| Other expenses | | | 2,005 | | | 1,822 | | | 523 | | | 764 |
| Less - R&D grant | | | (3,089) | | | — | | | (989) | | | — |
| | | $16,700 | | $13,934 | | $6,923 | | $4,467 | ||||
NOTE 10 – SUBSEQUENT EVENTS
| a. | Since the end of the quarter ended September 30, 2026, the Company collected approximately $9.3 million from sales to Chiesi and approximately $3.0 million from sales to Fiocruz (Brazil). |
| b. | Since the end of the quarter ended September 30, 2026, the Company sold, in the aggregate, 1,798,325 shares of common stock under the Sales Agreement and the Company generated gross proceeds equal to approximately $4.9 million in connection with such sales (issuance costs were $0.1 million). |
| c. | Since the end of the quarter ended September 30, 2026, the Company issued, in the aggregate, 27,329 shares of common stock in connection with exercises of options to purchase 27,329 shares of common stock by certain current and former employees of the Company. The Company received cash proceeds equal to approximately $50,000 in connection with such exercises. |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.