Financial Performance - Protalix BioTherapeutics reported Q3 2024 revenues of $17.8 million, a 75% increase from $10.2 million in Q3 2023, primarily driven by a $6.8 million increase in sales to Chiesi and a $1.1 million increase in sales to Pfizer[9]. - Total revenues for the nine months ended September 30, 2024, were $35,181,000, an increase from $30,309,000 for the same period in 2023, representing a growth of approximately 16.5%[27]. - Net income for Q3 2024 was approximately $3.2 million, or $0.04 per share, compared to a net loss of $1.9 million in Q3 2023[17]. - The net loss for the period was $3,562,000, compared to a net income of $14,356,000 for the same period in 2023, indicating a significant decline in profitability[27]. - Operating income for the nine months ended September 30, 2024, was a loss of $3,292,000, contrasting with an operating income of $16,075,000 for the same period in 2023[27]. - The company reported a basic loss per share of $0.05 for the nine months ended September 30, 2024, compared to earnings of $0.22 for the same period in 2023[27]. Expenses - The cost of goods sold for Q3 2024 was $8.4 million, a 71% increase from $4.9 million in Q3 2023, attributed to higher sales volumes[11]. - Research and development expenses decreased by 19% to approximately $3.0 million in Q3 2024, down from $3.7 million in Q3 2023, due to the completion of the Fabry clinical program[13]. - Selling, general and administrative expenses were $2.6 million in Q3 2024, a 30% decrease from $3.7 million in Q3 2023, primarily due to reduced salary and professional fees[14]. - Research and development expenses for the nine months ended September 30, 2024, were $8,846,000, down from $13,991,000 for the same period in 2023, a decrease of approximately 36.5%[27]. - Selling, general and administrative expenses decreased to $9,194,000 for the nine months ended September 30, 2024, from $10,816,000 in the same period in 2023, a reduction of about 15%[27]. Cash and Assets - Cash and cash equivalents stood at approximately $27.4 million as of September 30, 2024[16]. - Cash and cash equivalents increased to $27,409,000 as of September 30, 2024, up from $23,634,000 at the end of 2023[26]. - Total current assets decreased to $47,853,000 as of September 30, 2024, down from $69,932,000 at the end of 2023, reflecting a decline of approximately 31.6%[26]. - Total liabilities decreased to $29,126,000 as of September 30, 2024, compared to $50,865,000 at the end of 2023, a reduction of about 42.5%[26]. Clinical Development - The company completed all eight cohorts of its Phase I clinical trial for PRX-115, with 64 subjects enrolled, and is planning to initiate a Phase II trial in the second half of 2025[2][3]. - Preliminary results showed that PRX-115 effectively reduced plasma uric acid levels, maintaining levels below 6.0 mg/dL for up to 12 weeks at the highest dose[4]. - Protalix's development pipeline includes PRX-115 for uncontrolled gout and PRX-119 for NETs-related diseases, among others[22]. Debt Management - The company repaid all outstanding principal and interest on its 7.50% Senior Secured Convertible Promissory Notes in September 2024, financed entirely with available cash[8].

Company Overview - Protalix BioTherapeutics, Inc. is a biopharmaceutical company focused on the development, production, and commercialization of recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based protein expression system [4] - The company is notable for being the first to receive U.S. FDA approval for a protein produced through a plant cell-based suspension expression system [4] - Protalix has licensed worldwide development and commercialization rights for taliglucerase alfa, its first product for Gaucher disease, to Pfizer Inc., while retaining full rights in Brazil [4] Recent Developments - Protalix announced that Dror Bashan, the Company's President and CEO, will present live at the Life Sciences Investor Forum on September 19, 2024 [1] - The event will allow real-time interaction with investors, and an archived webcast will be available for those unable to attend live [2] Product Pipeline - Protalix's development pipeline includes proprietary versions of recombinant therapeutic proteins targeting established pharmaceutical markets, such as: - PRX–115: a plant cell-expressed recombinant PEGylated uricase for uncontrolled gout [5] - PRX–119: a plant cell-expressed long-action DNase I for NETs-related diseases [5] - The company's second product, Elfabrio®, received approval from both the FDA and the European Medicines Agency in May 2023 [4] Partnerships - Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio [5]

Core Viewpoint - Protalix BioTherapeutics has successfully repaid all outstanding convertible notes, achieving a debt-free status and strengthening its financial position for ongoing operations [1][2]. Financial Position - The company has eliminated a total of $78.0 million in convertible notes, which had previously contributed to its financing over the last decade [2]. - The repayment was financed entirely with available cash, indicating strong financial discipline and a robust balance sheet [1][2]. Company Overview - Protalix BioTherapeutics specializes in the development and commercialization of recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based expression system [3]. - The company is notable for being the first to receive FDA approval for a protein produced through a plant cell-based expression system [3]. Product Pipeline - Protalix has licensed the worldwide rights for taliglucerase alfa, its first product for Gaucher disease, to Pfizer Inc., retaining full rights in Brazil [3]. - The company’s second product, Elfabrio®, received approval from both the FDA and the European Medicines Agency (EMA) in May 2023 [3]. - Protalix is collaborating with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio [4]. - The development pipeline includes PRX–115 for uncontrolled gout and PRX–119 for NETs-related diseases, among other proprietary therapeutic proteins [4].

Company to host conference call and webcast today at 8:30 a.m. EDT CARMIEL, Israel, Aug. 14, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the quarter ended June 30, 2024, and provided a business update. "In the second quarter, Protalix ha ...

Core Viewpoint - Protalix BioTherapeutics, Inc. will release its financial results for Q2 2024 and provide a business and clinical update on August 14, 2024 [1] Group 1: Financial Results and Updates - The company will host a conference call with investors to discuss financial results and recent corporate and regulatory developments [2] - The conference call is scheduled for August 14, 2024, at 8:30 a.m. EDT [3] Group 2: Conference Call and Webcast Details - Toll-free and international call details are provided for participants [3] - A webcast will be available, and participants are encouraged to access the call 15 minutes early [4] Group 3: Company Overview - Protalix specializes in the development and commercialization of recombinant therapeutic proteins using its ProCellEx plant cell-based expression system [5] - The company has FDA approval for its first product, taliglucerase alfa, for Gaucher disease, and its second product, Elfabrio®, was approved in May 2023 [5] - Protalix has partnered with Chiesi Farmaceutici for the global development of Elfabrio and has a pipeline of therapeutic proteins targeting various diseases [6]

About Aleš Linhart, DSc, FESC Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale ma ...

Corporate presentation scheduled for Monday, June 3, 2024 at 2:30 P.M. PDT CARMIEL, Israel, May 29, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell based protein expression system, announced today that Dror Bashan, its President and Chief Executive Officer, will present at the upcoming 2024 BIO International C ...

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q1 2024 Earnings Conference Call May 10, 2024 8:30 AM ET Company Participants Mike Moyer - Managing Director, LifeSci Advisors Dror Bashan - President and CEO Eyal Rubin - SVP and CFO Conference Call Participants Raghuram Selvaraju - H.C. Wainwright John Vandermosten - Zacks Small Cap Research Operator Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics First Quarter 2024 Financial and Business Results Conference Call. As a reminder, this ...

PART I – FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Protalix BioTherapeutics, Inc. as of March 31, 2024, and for the three months then ended [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2024, the company reported total assets of $89.8 million, an increase from $84.4 million at year-end 2023, driven by increases in cash and inventories Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $27,209 | $23,634 | | Inventories | $22,346 | $19,045 | | **Total Assets** | **$89,825** | **$84,434** | | **Liabilities & Equity** | | | | Contracts liability | $11,039 | $0 | | Convertible notes | $20,420 | $20,251 | | **Total Liabilities** | **$60,039** | **$50,865** | | **Total Stockholders' Equity** | **$29,786** | **$33,569** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2024, the company reported a net loss of $4.6 million, or ($0.06) per share, compared to a net loss of $3.1 million, or ($0.05) per share, for the same period in 2023 Q1 2024 vs. Q1 2023 Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Total Revenue | $3,748 | $9,588 | | Cost of Goods Sold | ($2,602) | ($3,085) | | R&D Expenses | ($2,887) | ($5,847) | | Operating Loss | ($4,856) | ($2,459) | | Net Loss | ($4,595) | ($3,131) | | Loss Per Share (Basic & Diluted) | ($0.06) | ($0.05) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the first quarter of 2024, net cash provided by operating activities was $4.2 million, a significant improvement from the $3.0 million used in the same period of 2023 Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $4,188 | ($2,998) | | Net cash provided by (used in) investing activities | ($606) | $4,732 | | Net cash provided by financing activities | $0 | $14,233 | | **Net increase in cash and cash equivalents** | **$3,575** | **$15,925** | | **Cash and cash equivalents at end of period** | **$27,209** | **$33,036** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes provide detailed information on the company's accounting policies, business operations, and financial items, including its ProCellEx® platform and commercialization partnerships - The company's two commercialized products are Elfabrio® for Fabry disease and Elelyso® for Gaucher disease, both developed using the proprietary ProCellEx® protein expression system[23](index=23&type=chunk) - The development pipeline includes PRX-115 for uncontrolled gout, which is in a Phase I trial, and PRX-119 for NETs-related diseases[33](index=33&type=chunk)[35](index=35&type=chunk) Disaggregation of Revenues (in thousands) | Revenue Source | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Pfizer | $1,127 | $2,266 | | Brazil | $2,550 | $2,800 | | **Total revenues from selling goods** | **$3,677** | **$5,066** | | Revenues from license and R&D services | $71 | $4,522 | - The company believes its cash, cash equivalents, and short-term bank deposits as of March 31, 2024, are sufficient to fund capital needs for at least 12 months from the financial statement issuance date[47](index=47&type=chunk) - Subsequent to the quarter's end, the company collected approximately **$1.1 million** from Pfizer and **$2.6 million** from Brazil sales[72](index=72&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance for Q1 2024, recent developments, and strategic outlook, highlighting product commercialization and pipeline progress [Marketed Products and Development Pipeline](index=22&type=section&id=Products%20and%20Product%20Pipeline) The company has two commercial products: Elelyso for Gaucher disease and Elfabrio for Fabry disease, with a development pipeline focused on rare diseases, led by PRX-115 for gout - Elfabrio® was approved by the FDA and European Commission in May 2023 for adult patients with Fabry disease[95](index=95&type=chunk) - The Phase I trial for PRX-115 (gout) was expanded to an eighth cohort to test a higher dose, and preparations for a Phase II trial have commenced[76](index=76&type=chunk)[156](index=156&type=chunk) - The pipeline also includes PRX-119, a long-acting DNase I for NETs-related diseases, which is in preclinical development[162](index=162&type=chunk)[163](index=163&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Comparing Q1 2024 to Q1 2023, total revenues decreased by 61% to $3.7 million, primarily due to a $4.4 million drop in license and R&D service revenues, partially offset by a 50% reduction in R&D expenses Comparison of Operations for Three Months Ended March 31 (in millions) | Item | 2024 | 2023 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenues from Selling Goods | $3.7 | $5.1 | -27% | Decrease in sales to Pfizer and Brazil due to timing of delivery | | Revenues from License and R&D Services | $0.1 | $4.5 | -98% | Completion of R&D obligations and regulatory processes for Elfabrio | | R&D Expenses | $2.9 | $5.8 | -50% | Completion of the Fabry clinical program | | SG&A Expenses | $3.1 | $3.1 | 0% | Remained stable | [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2024, the company had $48.5 million in cash, cash equivalents, and short-term bank deposits, which management believes are sufficient to cover capital needs for at least the next 12 months - The company had **$48.5 million** in cash, cash equivalents, and short-term bank deposits as of March 31, 2024[180](index=180&type=chunk) - Management asserts that current cash is sufficient to satisfy capital needs for at least 12 months from the report's issuance date[185](index=185&type=chunk)[191](index=191&type=chunk) - Net cash provided by operations was **$4.2 million** for Q1 2024, primarily due to an **$11.0 million** increase in contracts liability[186](index=186&type=chunk) - As of March 31, 2024, approximately **$6.4 million** remains available for sale under the 2023 At-The-Market (ATM) Sales Agreement[194](index=194&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is currency exchange risk between the U.S. dollar and the New Israeli Shekel (NIS), as approximately 44% of its operational costs are incurred in NIS - The company's main market risk is currency fluctuation between the U.S. dollar (functional currency) and the New Israeli Shekel (NIS), as approximately **44%** of its costs are in NIS[197](index=197&type=chunk)[198](index=198&type=chunk) - The company does not currently engage in hedging transactions to mitigate currency exchange risk[198](index=198&type=chunk) [Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that as of the end of the quarter, the company's disclosure controls and procedures were effective[200](index=200&type=chunk) - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[202](index=202&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not involved in any material legal proceedings - The company is not involved in any material legal proceedings[204](index=204&type=chunk) [Risk Factors](index=43&type=page&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2023 - No material changes to risk factors were reported since the last Annual Report on Form 10-K[205](index=205&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[206](index=206&type=chunk) [Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the CEO and CFO pursuant to the Sarbanes-Oxley Act of 2002 and XBRL data files - Exhibits filed include CEO and CFO certifications (31.1, 31.2, 32.1, 32.2) and Inline XBRL documents[211](index=211&type=chunk)

Exhibit 99.1 Protalix BioTherapeutics Reports First Quarter 2024 Financial and Business Results Company to host conference call and webcast today at 8:30 a.m. EDT CARMIEL, Israel, May 10, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the q ...