Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K FOR ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTIONS 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 001-33357 (Commission file number) P ...

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q3 2022 Results Conference Call November 14, 2022 8:30 AM ET Company Participants Chuck Padala - LifeSci Advisors Dror Bashan - President, CEO Eyal Rubin - SVP, CFO Conference Call Participants Boobalan Pachaiyappan - H.C. Wainwright John Vandermosten - Zacks Operator Greetings, and welcome to the Protalix BioTherapeutics Third Quarter 2022 Financial and Business Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR (201)-696-9345 (Registrant's telephone number, including area code) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 001-33357 (Commission file number) PROTALIX BIOTHERAPEUTICS, INC. (Exact name of re ...

Protalix BioTherapeutics Inc. (NYSE:PLX) Q2 2022 Earnings Conference Call August 15, 2022 8:30 AM ET Company Participants Chuck Padala - LifeSci Advisors, Investor Relations Dror Bashan - President, CEO and Director Eyal Rubin - Senior VP, CFO, Treasurer and Corporate Secretary Conference Call Participants Boobalan Pachaiyappan - H.C. Wainwright John Vandermosten - Zacks Operator Good morning, ladies and gentlemen, and welcome to the Protalix Second Quarter 2022 Financial and Business Results Conference Ca ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 001-33357 (Commission file number) PROTALIX BIOTHERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware __65-0643773__ (State or o ...

Protalix BioTherapeutics Inc. (NYSE:PLX) Q1 2022 Earnings Conference Call May 16, 2022 8:30 AM ET Company Participants Alexandra Schuman - LifeSci Advisors, IR Dror Bashan - President & CEO Eyal Rubin - SVP & CFO Conference Call Participants John Vandermosten - Zacks Small Cap Research Operator Good morning, ladies and gentlemen, and welcome to the Protalix First Quarter 2022 Financial and Business Results Conference Call. [Operator Instructions] I do reminder, this conference call is being recorded. I wil ...

OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 001-33357 FORM 10-Q (Commission file number) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 Delaware __65-0643773__ (State or other jurisdiction of incorporation or organization) Securities registered pursuant to ...

Protalix BioTherapeutics Inc. (NYSE:PLX) Q4 2021 Earnings Conference Call March 31, 2022 8:30 AM ET Company Participants Dror Bashan - President, Chief Executive Officer Eyal Rubin - Senior Vice President, Chief Financial Officer Charles Padala - LifeSci Advisors Conference Call Participants John Vandermosten - Zacks Small Cap Research Operator Good morning ladies and gentlemen and welcome to Protalix BioTherapeutics’ full year 2021 earnings conference call. At this time, all participants are in a listen ...

Part I [Business](index=4&type=section&id=Item%201.%20Business) Protalix BioTherapeutics leverages its ProCellEx® platform for therapeutic protein production, marketing Elelyso® and advancing PRX-102 for Fabry disease - The company's core technology is the **ProCellEx® platform**, a plant cell-based system for producing recombinant therapeutic proteins, making it the **first and only company to gain FDA approval** for a protein produced this way[13](index=13&type=chunk)[19](index=19&type=chunk) - The lead product candidate is **pegunigalsidase alfa (PRX-102)** for **Fabry disease**, which is in advanced clinical stages, with other pipeline products including PRX-115 for gout and PRX-119 for NETs-related diseases[17](index=17&type=chunk)[27](index=27&type=chunk) - **Elelyso®**, for Gaucher Disease, is the company's **first and only approved product**, marketed globally through an exclusive licensing agreement with Pfizer (excluding Brazil), and in Brazil as BioManguinhos alfataliglicerase through an agreement with Fiocruz[26](index=26&type=chunk)[48](index=48&type=chunk) 2021 Revenue from Elelyso® in Brazil | Region | Product Name | 2021 Sales (in millions) | Source | | :--- | :--- | :--- | :--- | | Brazil | BioManguinhos alfataliglicerase | $6.4 | Fiocruz (Brazilian MoH) | [Product Pipeline Overview](index=6&type=section&id=Product%20Pipeline%20Overview) The company's pipeline is led by PRX-102 for Fabry disease, with other candidates in preclinical or early clinical development for various indications Product Development Pipeline Status | Product Candidate | Indication | Development Stage | | :--- | :--- | :--- | | pegunigalsidase alfa (PRX-102) | Fabry Disease | Marketing Application | | alidornase alfa (PRX-110) | Various Respiratory Indications | Phase 2 Completed | | uricase (PRX-115) | Refractory Gout | Preclinical | | Long Acting (LA) DNase I (PRX-119) | NETs Related Diseases | Preclinical | [Pegunigalsidase alfa (PRX-102) for Fabry Disease](index=9&type=section&id=Pegunigalsidase%20alfa%20%28PRX-102%29%20for%20Fabry%20Disease) PRX-102 for Fabry disease completed Phase III, with an EMA MAA submitted and BLA resubmission to the FDA planned for H2 2022 after a CRL - A **Marketing Authorization Application (MAA)** for PRX-102 was submitted to and validated by the European Medicines Agency (**EMA**) on **February 7, 2022**[29](index=29&type=chunk)[38](index=38&type=chunk)[53](index=53&type=chunk) - The U.S. FDA issued a **Complete Response Letter (CRL)** for the PRX-102 BLA on **April 28, 2021**, citing the inability to conduct a required manufacturing facility inspection and noting the recent full approval of **Fabrazyme®**, but not raising safety or efficacy concerns[30](index=30&type=chunk)[46](index=46&type=chunk)[56](index=56&type=chunk) - Following a Type A meeting with the FDA, the company plans to **resubmit the BLA** with a data package including the final **two-year analyses of the BALANCE study**, which has the potential to support a traditional approval[31](index=31&type=chunk)[57](index=57&type=chunk)[72](index=72&type=chunk) - The **Phase III BRIGHT study** showed that PRX-102 administered at **2 mg/kg every four weeks** was well tolerated and **maintained disease stability** in patients switched from other ERTs, suggesting a **reduced treatment burden**[80](index=80&type=chunk)[85](index=85&type=chunk) [Intellectual Property](index=29&type=section&id=Intellectual%20Property) The company protects its ProCellEx® technology and products with over 80 granted patents and 30 pending applications, securing its 2024 Notes - The company holds a global portfolio of over **80 patents** and has more than **30 pending patent applications** to protect its technology, products, and methods[102](index=102&type=chunk) - The company's outstanding **2024 Notes** are secured by perfected liens on all material assets, primarily consisting of its intellectual property[105](index=105&type=chunk) [Agreements and Partnerships](index=35&type=section&id=Agreements%20and%20Partnerships) Protalix partners with Pfizer for Elelyso® and Chiesi for PRX-102, with the latter offering potential for over **$1.0 billion** in milestones and tiered royalties - The company has two exclusive global licensing and supply agreements with Chiesi for PRX-102, with potential revenue from up to **$45 million** in development cost reimbursements, over **$1.0 billion** in milestone payments, and tiered royalties from **15% to 40%**[125](index=125&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk) - In May 2021, Chiesi made a **$10.0 million payment** in exchange for a **$25.0 million reduction** in a long-term regulatory milestone, providing Protalix with near-term capital[45](index=45&type=chunk)[128](index=128&type=chunk) - Under the Amended Pfizer Agreement, Pfizer holds global rights to Elelyso (ex-Brazil), retains **100% of revenue**, and reimburses **100% of direct costs**, with Protalix continuing to supply the drug substance to Pfizer[120](index=120&type=chunk) [Government Regulations and Programs](index=39&type=section&id=Government%20Regulations%20and%20Programs) The company is subject to extensive FDA and international regulations, benefiting from PRX-102's Fast Track and Orphan Drug designations, and receives Israeli government grants with associated obligations - The FDA granted **Fast Track designation** to PRX-102 in January 2018 to facilitate its development and expedite its review[58](index=58&type=chunk)[155](index=155&type=chunk) - The European Commission granted **Orphan Drug Designation** for PRX-102 in December 2017, which could provide **10 years of market exclusivity** in the EU if approved[59](index=59&type=chunk)[151](index=151&type=chunk) - The company's Israeli subsidiary has received grants from the National Authority for Technological Innovation (NATI) totaling approximately **$53.2 million**, with a contingent liability to repay up to **$38.6 million** through royalties of **3-6%** on revenues from NATI-funded projects[198](index=198&type=chunk) - Receiving NATI grants restricts the company from manufacturing products or transferring technology outside of Israel without special approval, which may require increased royalty payments[199](index=199&type=chunk)[200](index=200&type=chunk) [Risk Factors](index=63&type=section&id=Item%201A.%20Risk%20Factors) Protalix faces substantial risks including regulatory uncertainty for PRX-102, financial instability, dependence on key partnerships, and operational challenges compounded by its Israeli base - A primary risk is the uncertainty of U.S. regulatory approval for PRX-102 following the FDA's **Complete Response Letter (CRL)**, which requires a facility inspection delayed by COVID-19 and must address the full approval of a competing therapy, **Fabrazyme®**[219](index=219&type=chunk)[225](index=225&type=chunk) - The company is heavily dependent on the successful commercialization of its lead candidate, **pegunigalsidase alfa (PRX-102)**, and any failure or significant delay would materially harm the business[256](index=256&type=chunk)[259](index=259&type=chunk) - Financial stability is a risk, as the company has a limited operating history, is not currently profitable, and will need to raise additional capital, which may not be available on favorable terms[255](index=255&type=chunk)[309](index=309&type=chunk)[311](index=311&type=chunk) - The company's outstanding **2024 Notes** are secured by all of its assets, including intellectual property, where a default could lead to foreclosure on these critical assets[297](index=297&type=chunk)[335](index=335&type=chunk) - Operations are concentrated in Israel, exposing the company to potential political, economic, and military instability that could disrupt research, development, and manufacturing[349](index=349&type=chunk) [Properties](index=115&type=section&id=Item%202.%20Properties) The company's primary operations, including headquarters and manufacturing, are in a leased facility in Carmiel, Israel, with a U.S. corporate office in Hackensack, New Jersey - The main facilities, including manufacturing, R&D, and offices, are located in a leased property in Carmiel, Israel, with the lease running until **2026** and an option to extend for another **five years**[379](index=379&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=116&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock is dual-listed on the NYSE American and TASE under 'PLX', with equity compensation plan details provided as of December 31, 2021 - The company's common stock is dual-listed on the **NYSE American** and the **Tel Aviv Stock Exchange** under the ticker symbol **\"PLX\"**[384](index=384&type=chunk) Equity Compensation Plan Information (as of Dec 31, 2021) | Plan Category | Securities to be Issued Upon Exercise of Outstanding Options | Weighted Average Exercise Price ($) | Securities Remaining Available for Future Issuance | | :--- | :--- | :--- | :--- | | Approved by Stockholders | 2,259,020 | $4.42 | 1,786,256 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=117&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Total revenues decreased to **$38.4 million** in 2021, leading to a **$27.6 million** net loss, despite improved liquidity from a **$40.2 million** public offering and debt restructuring Financial Performance Summary (2021 vs. 2020) | Metric | 2021 (in millions) | 2020 (in millions) | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $38.4 | $62.9 | -39% | | - Revenues from Selling Goods | $16.7 | $16.2 | +3% | | - Revenues from License & R&D | $21.6 | $46.7 | -54% | | Cost of Goods Sold | $16.3 | $10.9 | +50% | | R&D Expenses, Net | $29.7 | $38.2 | -22% | | SG&A Expenses | $12.7 | $11.1 | +14% | | Net Loss | $(27.6) | $(6.5) | Increased Loss | - The decrease in total revenue was primarily due to a **$25.1 million (54%) decrease** in revenues from license and R&D services recognized from the Chiesi Agreements, resulting from lower costs incurred during the year[436](index=436&type=chunk) - The company strengthened its balance sheet in 2021 by raising approximately **$40.2 million** from a public offering and **$8.8 million** from its ATM program[444](index=444&type=chunk) - In August 2021, the company exchanged **$54.65 million** of its 2021 Notes for **$28.75 million** of new 2024 Notes and **$25.90 million** in cash, extending its debt maturity[390](index=390&type=chunk)[445](index=445&type=chunk) - The company ended 2021 with **$39.0 million** in cash and cash equivalents and believes these funds are sufficient to meet capital needs for at least the next **12 months**[443](index=443&type=chunk)[451](index=451&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=134&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are currency exchange rate fluctuations, with **31%** of costs in NIS, and interest rate risk on cash and equivalents, with no current hedging strategies employed - The company's primary market risk is currency exchange risk, as its functional currency is the U.S. dollar, but approximately **31%** of its costs are incurred in **New Israeli Shekels (NIS)**[462](index=462&type=chunk)[464](index=464&type=chunk) - Interest rate risk is limited to cash and cash equivalents, with the main objective being principal preservation, and the company does not use derivative financial instruments to hedge this risk[465](index=465&type=chunk) [Controls and Procedures](index=136&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2021, with no material changes in the fourth quarter - Management concluded that as of **December 31, 2021**, the company's disclosure controls and procedures were effective[471](index=471&type=chunk) - Based on an assessment using the **COSO framework**, management concluded that the company's internal control over financial reporting was effective as of **December 31, 2021**[474](index=474&type=chunk) Part III [Directors, Executive Officers, Corporate Governance, Compensation, and Principal Accountant Fees](index=140&type=section&id=Items%2010-14) Information regarding directors, executive officers, corporate governance, compensation, and principal accountant fees is incorporated by reference from the company's 2022 Proxy Statement - Information regarding directors, executive officers, corporate governance, executive compensation, security ownership, and principal accountant fees and services is incorporated by reference from the registrant's **2022 Proxy Statement**[481](index=481&type=chunk)[482](index=482&type=chunk)[483](index=483&type=chunk)[484](index=484&type=chunk)[485](index=485&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=142&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section provides an index to the consolidated financial statements and a comprehensive list of all exhibits filed with the Form 10-K report - This section provides an index to the consolidated financial statements and a list of all exhibits filed with the **Form 10-K**, including material agreements and corporate governance documents[487](index=487&type=chunk)[488](index=488&type=chunk) Financial Statements [Consolidated Balance Sheets](index=154&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2021, total assets increased to **$73.7 million**, while total liabilities decreased to **$79.7 million** due to debt restructuring, improving capital deficiency Consolidated Balance Sheet Highlights (as of Dec 31) | Account (in thousands) | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $38,985 | $18,265 | | Total current assets | $61,666 | $55,723 | | **Total assets** | **$73,665** | **$67,934** | | **Liabilities & Capital** | | | | Total current liabilities | $33,176 | $86,474 | | Total long term liabilities | $46,525 | $8,497 | | **Total liabilities** | **$79,701** | **$94,971** | | **Total capital deficiency** | **$(6,036)** | **$(27,037)** | [Consolidated Statements of Operations](index=156&type=section&id=Consolidated%20Statements%20of%20Operations) For the year ended December 31, 2021, total revenues decreased to **$38.4 million**, resulting in an operating loss of **$20.5 million** and a net loss of **$27.6 million**, or **$(0.62)** per share Consolidated Statement of Operations (Year Ended Dec 31) | Account (in thousands) | 2021 (in thousands) | 2020 (in thousands) | 2019 (in thousands) | | :--- | :--- | :--- | :--- | | Total Revenue | $38,350 | $62,898 | $54,693 | | Operating Income (Loss) | $(20,462) | $2,710 | $(10,717) | | Financial Expenses, Net | $(7,120) | $(9,233) | $(7,559) | | **Net Loss** | **$(27,582)** | **$(6,523)** | **$(18,276)** | | **Loss Per Share (Basic & Diluted)** | **$(0.62)** | **$(0.22)** | **$(1.23)** | [Consolidated Statements of Cash Flows](index=158&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$10.3 million** in 2021, with investing and financing activities providing **$18.9 million** and **$12.1 million** respectively, increasing cash by **$20.7 million** Consolidated Statement of Cash Flows Highlights (Year Ended Dec 31) | Account (in thousands) | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,285) | $(26,106) | | Net cash provided by (used in) investing activities | $18,921 | $(19,952) | | Net cash provided by financing activities | $12,078 | $46,467 | | **Net increase in cash and cash equivalents** | **$20,720** | **$473** | | **Cash and cash equivalents at end of year** | **$38,985** | **$18,265** | [Notes to Consolidated Financial Statements](index=161&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, commercial agreements, debt instruments, and share capital, including revenue recognition for Chiesi agreements, the August 2021 debt exchange, and **$247.9 million** in tax loss carryforwards - Revenue from the Chiesi agreements' license and R&D services is recognized over time using a **cost-to-cost method**, based on the ratio of costs incurred to date to total estimated costs at completion[516](index=516&type=chunk)[578](index=578&type=chunk) - The August 2021 exchange of 2021 Notes for 2024 Notes was accounted for as a **debt extinguishment**, resulting in a recognized loss of **$0.8 million** and a reduction of stockholders' equity of **$12.2 million**[433](index=433&type=chunk)[667](index=667&type=chunk) - As of December 31, 2021, the company had aggregate **Net Operating Loss (NOL) carryforwards** of approximately **$247.9 million** available to reduce future taxable income[701](index=701&type=chunk) - The company has royalty commitments to Israel's NATI, with a maximum total royalty amount payable of approximately **$38.6 million** as of December 31, 2021, contingent on sales of products developed with NATI funding[630](index=630&type=chunk)

Start Time: 08:30 January 1, 0000 8:48 AM ET Protalix BioTherapeutics, Inc. (NYSE:PLX) Q3 2021 Earnings Conference Call November 15, 2021, 08:30 AM ET Company Participants Dror Bashan - President and CEO Eyal Rubin - SVP and CFO Chuck Padala - LifeSci Advisors, IR Conference Call Participants Boobalan Pachaiyappan - H.C. Wainwright John Vandermosten - Zacks Operator Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Third Quarter 2021 Financial Results and Business Update Confer ...