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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 001-33357 (Commission file number) PROTALIX BIOTHERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware __65-0643773__ (State or other jurisdiction of incorpor ...

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q2 2021 Earnings Conference Call August 16, 2021 8:30 AM ET Company Participants David Holmes - LifeSci Advisors, Investor Relations Dror Bashan - President & Chief Executive Officer Eyal Rubin - Senior Vice President & Chief Financial Officer Conference Call Participants Boobalan Pachaiyappan - H.C. Wainwright John Vandermosten - Zacks Investments Operator Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Second Quarter 2021 Financial ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 001-33357 (Commission file number) 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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading Symbol(s) | registered | | -- ...

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q1 2021 Earnings Conference Call May 14, 2021 8:30 AM ET Company Participants Chuck Padala - LifeSci Advisors Dror Bashan - President & Chief Executive Officer Eyal Rubin - Senior Vice President & Chief Financial Officer Conference Call Participants Boobalan Pachaiyappan - H.C. Wainwright John Vandermosten - Zacks Investments Operator Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics First Quarter 2021 Financial and Business Results Con ...

Table of Contents 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 March 31, 2021 ☐ 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 __65-06437 ...

Financial Data and Key Metrics Changes - For the year ended December 31, 2020, the company recorded revenues from selling goods of $16.2 million, compared to $15.8 million for the same period in 2019, indicating a slight increase [26] - Revenues from license and R&D services for the year ended December 31, 2020 were $46.7 million, up from $38.8 million in 2019, primarily due to revenue recognized from updated cost estimations of completed Phase III clinical trials of PRX-102 [26] - Research and development expenses net for 2020 were $38.2 million, down from $44.6 million in 2019, attributed to the completion of two Phase III clinical trials and reduced costs related to the BALANCE study [27] - Selling, general and administrative expenses increased to $11.1 million in 2020 from $9.9 million in 2019, mainly due to higher share-based compensation costs [28] - Cash, cash equivalents, and short-term bank deposits were approximately $38.5 million at the end of 2020, compared to approximately $18 million at the end of 2019 [29] Business Line Data and Key Metrics Changes - The lead pipeline candidate, PRX-102, is aimed at treating Fabry disease, with the therapeutic market forecasted to be around $1.9 billion in 2021, growing at a CAGR of approximately 9.5% [10] - The company has submitted a BLA for PRX-102 to the U.S. FDA, with a priority review status and an adjusted PDUFA date of April 27, 2021 [11] Market Data and Key Metrics Changes - The company anticipates that the market opportunity for moderate to severe pulmonary sarcoidosis could be significant, potentially reaching hundreds of millions of dollars, although it is difficult to estimate if it will exceed $1 billion in the coming years [39] Company Strategy and Development Direction - The company aims to advance its clinical programs and has a roadmap for upcoming strategic milestones, including the potential commercial launch of PRX-102 later in 2021 [6][8] - The company is also developing additional candidates such as PRX-110 for respiratory diseases and PRX-115 for refractory gout, with plans to commence Phase 1 clinical trials in 2022 [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and operational readiness despite challenges posed by the global pandemic, looking forward to an exciting year ahead [23][32] - The company is prepared for the commercial launch of PRX-102, with all necessary preparations in place, including marketing and sales teams [38] Other Important Information - The company raised approximately $40 million in gross proceeds through a public equity offering in early 2021 and an additional $8.8 million through its ATM program [30] - The company has $58 million of convertible notes on its balance sheet that could potentially be redeemed in December 2021 [30] Q&A Session Summary Question: What are your thoughts on Elelyso sales performance in 2020, and what are your expectations for 2021? - Management indicated that Elelyso sales were approximately $16 million in 2020, with expectations for 2021 to remain similar, potentially slightly better, but impacted by the pandemic in Brazil [34] Question: What are your expectations regarding the PDUFA date for PRX-102? - Management confirmed the PDUFA date is April 27, 2021, and they are prepared for a launch shortly after approval [35] Question: Can you comment on the launch preparation activities for PRX-102 and pricing information? - Management stated that preparations are complete and will discuss pricing post-approval [37] Question: What is the market opportunity for moderate to severe pulmonary sarcoidosis? - Management noted that there is a significant unmet need in this area, estimating a market potential of hundreds of millions of dollars [39] Question: What are the implications of the BRIGHT study for modifying the label for PRX-102? - Management indicated that the BRIGHT study outcomes are not part of the submitted BLA, but they plan to submit a clinical supplement post-approval [43] Question: How are FDA inspections going? - Management did not provide specific insights but assured that updates will be shared once available [49]

Part I [Business](index=4&type=section&id=Item%201.%20Business) Protalix BioTherapeutics develops and commercializes recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based system, with Elelyso® marketed and PRX-102 under FDA Priority Review [Our ProCellEx Platform](index=6&type=section&id=Our%20ProCellEx%20Platform) ProCellEx is a proprietary plant cell-based protein expression system, FDA-approved for Elelyso®, offering scalable manufacturing and no viral contamination risk - ProCellEx is a proprietary platform for manufacturing recombinant proteins using plant cell-based expression in suspension, which avoids the use of mammalian components and the associated risk of viral contamination[17](index=17&type=chunk)[18](index=18&type=chunk) - The system utilizes genetically engineered plant cells, such as carrot and tobacco, grown in custom-designed, sterile, disposable polyethylene bioreactors, allowing for rapid and low-cost horizontal scale-up[21](index=21&type=chunk)[22](index=22&type=chunk) [Our Marketed Product and Clinical Pipeline](index=8&type=section&id=Our%20Marketed%20Product%20and%20Clinical%20Pipeline) The company's portfolio includes Elelyso® for Gaucher disease and a clinical pipeline led by PRX-102 for Fabry disease, currently under FDA Priority Review Product Pipeline Status | Product Candidate | Indication | Development Stage | | :--- | :--- | :--- | | **Elelyso®** | Gaucher Disease | Marketed | | **pegunigalsidase alfa (PRX-102)** | Fabry Disease | BLA Submitted (FDA Priority Review) | | **alidornase alfa (PRX-110)** | Respiratory Diseases | Phase IIa completed; Licensed to SarcoMed | | **uricase (PRX-115)** | Refractory Gout | Preclinical | | **Long Acting DNase (PRX-119)** | NETs Related Diseases | Preclinical | - Elelyso® is approved and marketed in 23 countries for Gaucher disease. Sales in Brazil, marketed as BioManguinhos alfataliglicerase, generated **$8.0 million in 2020**[23](index=23&type=chunk)[47](index=47&type=chunk) - The FDA accepted the Biologics License Application (BLA) for PRX-102 for Fabry disease, granting it **Priority Review** with a PDUFA action date of **April 27, 2021**. However, FDA inspections of manufacturing facilities may be delayed due to COVID-19 travel restrictions[24](index=24&type=chunk)[38](index=38&type=chunk)[54](index=54&type=chunk) - The company entered an exclusive worldwide license agreement with SarcoMed for alidornase alfa (PRX-110) for use in human respiratory diseases, including sarcoidosis and pulmonary fibrosis[29](index=29&type=chunk)[34](index=34&type=chunk) [Intellectual Property](index=26&type=section&id=Intellectual%20Property) The company holds over 90 global patents and 35 pending applications protecting its ProCellEx technology and products, serving as collateral for 2021 convertible notes - The company holds a global portfolio of over **90 patents** and has more than **35 pending patent applications** to protect its technology, products, and methods of use[97](index=97&type=chunk) - In **2020**, the company secured new patents in Europe for its "Large Scale Disposable Bioreactor" and in Israel and the U.S. for "Stabilized Alpha-Galactosidase and Uses Thereof" (related to PRX-102)[98](index=98&type=chunk) - The company's material assets, primarily its intellectual property, are pledged as collateral to secure its outstanding **7.50% convertible promissory notes due in 2021**[101](index=101&type=chunk) [Agreements and Partnerships](index=32&type=section&id=Agreements%20and%20Partnerships) Protalix maintains strategic partnerships with Pfizer for Elelyso® and Chiesi for PRX-102, involving significant upfront payments, potential milestones, and royalties - Pfizer holds the exclusive global rights to Elelyso (excluding Brazil) under an amended agreement where Pfizer covers **100% of costs** and retains **100% of revenue**, while Protalix serves as the drug substance manufacturer for a **10-year period**[116](index=116&type=chunk)[117](index=117&type=chunk) - The company has two exclusive global agreements with Chiesi for PRX-102, covering ex-U.S. and U.S. markets. These agreements include **$50 million in upfront payments**, up to **$45 million in development cost reimbursements**, over **$1.0 billion in potential milestones**, and tiered royalties ranging from **15% to 40%**[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - The company commercializes Elelyso in Brazil as BioManguinhos alfataliglicerase through an agreement with Fiocruz. However, Fiocruz has not met certain purchase commitments, and discussions are ongoing to address this[118](index=118&type=chunk)[119](index=119&type=chunk) [Manufacturing and Government Regulations](index=36&type=section&id=Manufacturing%20and%20Government%20Regulations) The company operates an FDA-approved cGMP manufacturing facility in Israel and is subject to extensive global regulations, benefiting from Israeli government tax and R&D programs - The manufacturing facility in Carmiel, Israel, is **FDA-approved** as a multi-product facility and has sufficient capacity for current and expected commercial and clinical needs, including the anticipated launch of PRX-102[123](index=123&type=chunk)[124](index=124&type=chunk) - The company is subject to extensive regulation by the FDA and other global authorities, covering preclinical studies, clinical trials (Phase I-III), manufacturing (cGMP), and post-approval requirements[129](index=129&type=chunk)[132](index=132&type=chunk)[135](index=135&type=chunk) - The company's Israeli facility has "Approved Enterprise" status, making it eligible for a **10-year tax exemption period** once it generates taxable income. It also receives R&D grants from NATI, which require royalty payments on future sales of funded products[126](index=126&type=chunk)[182](index=182&type=chunk)[192](index=192&type=chunk) [Risk Factors](index=61&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including PRX-102 approval delays, clinical and regulatory uncertainties, dependence on key products and partners, financial instability, and geopolitical risks in Israel - A key risk is the potential delay or failure to obtain FDA approval for PRX-102 by the **April 27, 2021 PDUFA date**, as COVID-19 travel restrictions may prevent the FDA from conducting required pre-license inspections of manufacturing facilities[213](index=213&type=chunk) - The company's financial stability is at risk due to its history of net losses, significant indebtedness from **$57.9 million in convertible notes due 2021**, and the need to raise additional capital to fund operations and clinical trials[278](index=278&type=chunk)[285](index=285&type=chunk) - Heavy reliance on the commercial success of PRX-102 and the performance of collaboration partners like Chiesi and Pfizer creates significant business risk. Failure in these areas would materially harm the company's financial condition[238](index=238&type=chunk)[243](index=243&type=chunk) - Operations are concentrated in Israel, exposing the company to risks from political, economic, and military instability, as well as restrictions tied to Israeli government R&D grants that limit the transfer of technology and manufacturing outside of Israel[327](index=327&type=chunk)[334](index=334&type=chunk) [Properties](index=110&type=section&id=Item%202.%20Properties) The company's primary operations, including manufacturing and R&D, are in a leased Carmiel, Israel facility, with a corporate office in Hackensack, New Jersey - The main facility in Carmiel, Israel, houses manufacturing, R&D labs, and offices, totaling approximately **58,900 sq/ft** of utilized space, with an additional **14,500 sq/ft** available for future expansion[357](index=357&type=chunk) [Legal Proceedings](index=110&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - As of the report date, the company is not a party to any material legal proceedings[358](index=358&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=111&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 trades on NYSE American and TASE, with details on equity compensation plan securities and outstanding options Equity Compensation Plan Information (as of Dec 31, 2020) | Plan Category | Securities to be Issued Upon Exercise of Outstanding Options | Weighted Average Exercise Price of Outstanding Options | Securities Remaining Available for Future Issuance | | :--- | :--- | :--- | :--- | | Approved by Stockholders | 2,551,650 | $5.30 | 1,493,626 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=112&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Total revenues increased to $62.9 million in 2020, net loss narrowed to $6.5 million, and recent financing activities strengthened liquidity for future operations and debt repayment Financial Performance Summary (Years ended Dec 31) | Metric (in millions) | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $62.9 | $54.7 | +15.0% | | - Revenues from Selling Goods | $16.2 | $15.9 | +1.9% | | - Revenues from License and R&D | $46.7 | $38.8 | +20.4% | | R&D Expenses, Net | $38.2 | $44.6 | -14.3% | | Net Loss | $(6.5) | $(18.3) | +64.5% improvement | - The increase in **2020 revenue** was primarily due to a **$7.9 million** rise in license and R&D service revenue from the Chiesi agreements, reflecting an updated cost estimation for completing clinical trials[411](index=411&type=chunk) - R&D expenses decreased by **$6.4 million** in 2020 compared to 2019, mainly because two of the three Phase III trials for PRX-102 were completed and costs for the ongoing BALANCE study were reduced[413](index=413&type=chunk) - As of December 31, 2020, the company had **$38.5 million** in cash and short-term deposits. Subsequent financing activities in early 2021, including a public offering and ATM sales, raised gross proceeds of approximately **$49.0 million**[418](index=418&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=127&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is currency exchange rate fluctuations, as 43% of costs are in NIS while its functional currency is USD - The company's main market risk is currency fluctuation, as approximately **43% of its costs** are in New Israeli Shekels (NIS) while its functional currency is the U.S. dollar[429](index=429&type=chunk)[432](index=432&type=chunk) [Financial Statements and Supplementary Data](index=129&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited consolidated financial statements and the independent auditor's report, highlighting revenue recognition for Chiesi agreements as a critical audit matter Consolidated Balance Sheet Data (as of Dec 31) | Metric (in thousands) | 2020 | 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents, and short-term deposits | $38,545 | $17,792 | | Total Current Assets | $55,723 | $32,479 | | Total Assets | $67,934 | $45,392 | | **Liabilities & Capital Deficiency** | | | | Total Current Liabilities | $86,474 | $40,175 | | Total Liabilities | $94,971 | $115,714 | | Total Capital Deficiency | $(27,037) | $(70,322) | - The independent auditor, Kesselman & Kesselman (PwC), identified revenue recognition for the license and R&D services performance obligation as a critical audit matter, citing the significant management judgment required to estimate total costs to completion[487](index=487&type=chunk)[489](index=489&type=chunk) [Controls and Procedures](index=129&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2020, with no material changes reported - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of **December 31, 2020**[440](index=440&type=chunk) - Management assessed internal control over financial reporting based on the COSO framework and concluded that it was effective as of **December 31, 2020**[443](index=443&type=chunk) Part III [Directors, Executive Officers, Corporate Governance, Compensation, and Principal Accountant Fees](index=134&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%20and%2014) Information on directors, executive officers, corporate governance, compensation, and principal accountant fees is incorporated by reference from the 2021 Proxy Statement - Information regarding directors, executive officers, corporate governance, executive compensation, security ownership, and principal accountant fees is incorporated by reference from the registrant's **2021 Proxy Statement**[451](index=451&type=chunk)[452](index=452&type=chunk)[453](index=453&type=chunk)[454](index=454&type=chunk)[455](index=455&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=135&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section provides an index of exhibits and financial statement schedules filed with the 10-K report, including key corporate and contractual documents - This section contains the index to the Consolidated Financial Statements and a list of all exhibits filed with the **10-K report**[457](index=457&type=chunk)[458](index=458&type=chunk)

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q3 2020 Results Conference Call October 29, 2020 8:30 AM ET Company Participants Chuck Padala - LifeSci Advisors, Investor Relations Dror Bashan - President & Chief Executive Officer Eyal Rubin - Chief Financial Officer Conference Call Participants Boobalan Pachaiyappan - H.C. Wainwright Operator Greetings and welcome to the Protalix Biopharmaceuticals Third Quarter 2020 Financial Results and Business Update. At this time all participants are in a listen-only mode. ...

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q2 2020 Results Earnings Conference Call August 10, 2020 8:30 AM ET Â Company Participants Chuck Padala - LifeSci Advisors, Investor Relations Dror Bashan - President and CEO Eyal Rubin - Chief Financial Officer Conference Call Participants Boobalan Pachaiyappan - H.C. Wainwright Operator Good morning, ladies and gentlemen. And welcome to the Protalix BioTherapeutics Second Quarter 2020 Earnings Call. As a reminder, this conference is being recorded. I would now lik ...

Protalix Bio Therapeutics (NYSE:PLX) Q1 2020 Earnings Conference Call June 1, 2020 8:30 AM ET Company Participants Dror Bashan - President, Chief Executive Officer Eyal Rubin - Senior Vice President, Chief Financial Officer Chuck Padala - Investor Relations Conference Call Participants Boobalan Pachaiyappan - HC Wainwright Philippa Gardner - Jefferies Walter Goering - private investor Operator Greetings and welcome to the Protalix Bio Therapeutics first quarter 2020 earnings conference call. At this time, a ...