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 ...

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q4 2023 Earnings Conference Call March 14, 2024 8:30 AM ET Company Participants Lauren Merrick - Investor Relations Dror Bashan - President and Chief Executive Officer Eyal Rubin - Senior Vice President and Chief Financial Officer Conference Call Participants John Vandermosten - Zacks Operator Good morning, ladies and gentlemen and welcome to the Protalix BioTherapeutics Fiscal Year 2023 Financial and Business Results Conference Call. As a reminder, this conference ...

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, 2023 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 ...

Exhibit 99.1 Protalix BioTherapeutics Reports Fiscal Year 2023 Financial and Business Results Company to host conference call and webcast today at 8:30 a.m. EDT CARMIEL, Israel, March 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 f ...

Financial Data and Key Metrics Changes - Cost of goods sold decreased by $2.2 million, or 31%, to $4.9 million for Q3 2023 compared to $7.1 million for Q3 2022, primarily due to decreased sales to Pfizer, partially offset by increased sales of Elfabrio to Chiesi and Elelyso to Brazil [8] - Net loss for Q3 2023 was approximately $1.9 million, or $0.03 per share, compared to a net loss of $3.6 million, or $0.07 per share, for the same period in 2022 [10] - Revenues from selling goods increased by $1.4 million, or 16%, to $10.2 million in Q3 2023 compared to $8.8 million in Q3 2022, driven by increased sales to Chiesi and Brazil, offset by decreased sales to Pfizer [31] - Total research and development expenses decreased by $3.7 million, or 50%, to approximately $3.7 million in Q3 2023 compared to $7.4 million in Q3 2022, primarily due to the completion of the Fabry clinical program [32] Business Line Data and Key Metrics Changes - Revenues from license and R&D services decreased by $5.2 million, or 96%, to $0.2 million in Q3 2023 compared to $5.4 million in Q3 2022, due to the transfer of sponsorship of extension studies to Chiesi [18] - Selling, general and administrative expenses increased by $0.9 million, or 32%, to $3.7 million in Q3 2023 compared to $2.8 million in Q3 2022, primarily due to increased salary and related expenses [19] Market Data and Key Metrics Changes - The company has received regulatory approvals for Elfabrio in the UK and Switzerland, with plans to expand into other markets, including Japan [38] - The company is focusing on building market presence and inventory with Chiesi, which is expected to fluctuate over the next couple of years [37] Company Strategy and Development Direction - The company is committed to developing its pipeline assets to address high unmet medical needs, following the approval of Elfabrio and Elelyso [15] - The company aims to maintain a strong balance sheet to support strategic plans without the need for near-term capital infusion [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to operate without disruptions despite challenging circumstances in Israel [14] - The company does not provide specific revenue guidance for Q4 2023 due to the dynamic nature of orders from Chiesi and Pfizer [42] Other Important Information - The company announced the appointment of Dr. Eliot Forster as Chairman of the Board, succeeding Mr. Zeev Bronfeld [30] - Cash, cash equivalents, and short-term bank deposits were approximately $41 million as of September 30, 2023 [20] Q&A Session Summary Question: What are the underlying factors for the drop in revenue from $15 million in Q2 to $10 million in Q3? - Management indicated that the decrease was due to reduced sales to Pfizer and inventory buildup by Chiesi, which may lead to fluctuations in sales as they penetrate the market [12][37] Question: Can you discuss the Fabry disease market opportunity in the UK and Switzerland? - Management noted that the drug has been approved in most Western countries, including the UK and Switzerland, and they are looking to expand into other markets like Japan [38] Question: What are the next steps for the PRX-115 program? - The company plans to gather data from the ongoing Phase 1 study and will decide on further steps based on safety and efficacy results [60] Question: How does the company view its capital structure with two revenue-generating products? - Management stated that the company is self-sustained and does not foresee the need for additional capital in the near future, expecting gradual changes in capital structure as revenues ramp up [52] Question: What are the expectations for the topline results from the PRX-115 study? - Management indicated that topline results are expected in mid-2024, and they will assess the data to determine the next steps for the program [16][54]