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, 2024 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 ...

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].

CARMIEL, Israel, Sept. 16, 2024 (GLOBE NEWSWIRE) -- 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 announced that Dror Bashan, the Company's President and Chief Executive Officer, will present live at the Life Sciences Investor Forum, hosted by VirtualInvestorConferences.com, on September 19, ...

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].

Protalix BioTherapeutics, Inc. (NYSE:PLX) Q2 2024 Earnings Conference Call August 14, 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 John Vandermosten - Zacks Small Cap Research Unidentified Analyst - H.C. Wainwright Operator Good morning, ladies and gentlemen and welcome to the Protalix BioTherapeutics Second Quarter 2024 Financial and Business Results Conference Call. As a reminder, ...

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, 2024 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 ...

Financial Performance - Protalix recorded revenues of $13.3 million for Q2 2024, a decrease of $1.8 million, or 12%, compared to $15.1 million in Q2 2023[4] - Revenues from license and R&D services fell to $0.2 million, a decrease of $19.8 million, or 99%, from $20.0 million in Q2 2023, primarily due to the absence of a regulatory milestone payment from Chiesi[4] - Total revenue for the six months ended June 30, 2024, was $17,222,000, a decrease of 61.4% compared to $44,663,000 for the same period in 2023[15] - Revenues from selling goods for the three months ended June 30, 2024, were $13,304,000, down 11.7% from $15,075,000 for the same period in 2023[15] - The net loss for Q2 2024 was approximately $2.2 million, or $0.03 per share, compared to a net income of $19.3 million, or $0.29 per share, in Q2 2023[7] - The company reported a net loss of $(6,798,000) for the six months ended June 30, 2024, compared to a net income of $16,208,000 for the same period in 2023[15] - Basic earnings per share for the six months ended June 30, 2024, was $(0.09), compared to $0.26 for the same period in 2023[15] Expenses - Cost of goods sold increased to $9.5 million, up $3.4 million, or 56%, from $6.1 million in Q2 2023, driven by higher sales to Pfizer and Brazil[4] - Total research and development expenses were approximately $3.0 million, a decrease of $1.5 million, or 33%, compared to $4.5 million in Q2 2023, mainly due to the completion of the Fabry clinical program[4] - Selling, general and administrative expenses decreased to $3.5 million, down $0.5 million, or 13%, from $4.0 million in Q2 2023[6] - Research and development expenses for the six months ended June 30, 2024, were $5,848,000, down 43.3% from $10,322,000 for the same period in 2023[15] Assets and Liabilities - Total current assets increased to $77,367,000 as of June 30, 2024, from $69,932,000 as of December 31, 2023, representing an increase of 10.4%[14] - Total liabilities rose to $62,959,000 as of June 30, 2024, compared to $50,865,000 as of December 31, 2023, indicating a 23.8% increase[14] - Cash and cash equivalents decreased slightly to $23,399,000 as of June 30, 2024, from $23,634,000 as of December 31, 2023[14] - Total assets increased to $91,540,000 as of June 30, 2024, from $84,434,000 as of December 31, 2023, reflecting an increase of 8.3%[14] Clinical Trials and Future Plans - Protalix anticipates topline results from the phase I clinical trial of PRX-115 for uncontrolled gout in Q3 2024[2] - The company has initiated preparations for a phase II clinical trial of PRX-115 based on encouraging safety results from the phase I trial[2] - Protalix's leadership provided insights into its strategy and future plans during an Investor Day event in June 2024[3]

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 ...

Company to host conference call and webcast at 8:30 a.m. EDT CARMIEL, Israel, Aug. 7, 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 announced that it will release its financial results for the quarter ended June 30, 2024 and provide a business and clinical update on Aug ...

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 ...