Protalix BioTherapeutics(PLX) - 2025 Q2 - Quarterly Results

Executive Summary Q2 2025 Performance Overview Protalix BioTherapeutics reported Q2 2025 financial results, with first-half revenues from product sales increasing 50% year-over-year, driven by Elfabrio® sales to Chiesi, anticipating quarterly fluctuations in global orders but strong long-term growth - Revenues from product sales increased by 50% year-over-year in the first half of 2025, primarily driven by Elfabrio® sales to Chiesi[2] - Elfabrio®, for Fabry disease treatment, has a current global market size of approximately $2.3 billion, projected to grow to $3.2 billion by 2030[2] - The company anticipates quarterly fluctuations in Elfabrio®'s global order patterns during its early launch phase but remains confident in its long-term growth potential[2] Strategic Business and Clinical Updates The company is advancing PRX-115 development, with a randomized Phase II trial expected to commence in H2 2025 and the first patient enrolled in Q4 2025 - Development of PRX-115, a recombinant PEGylated uricase product candidate for uncontrolled gout, continues to advance[2] - A randomized Phase II trial for PRX-115 is expected to be initiated in H2 2025, with the first patient enrolled in Q4 2025[2] Corporate and Management Changes The company announced Eyal Rubin's departure as CFO, with Gilad Mamlok appointed as his successor, effective August 24, 2025, to ensure a smooth transition - Eyal Rubin will step down as Chief Financial Officer, with Gilad Mamlok appointed as the new Senior Vice President and CFO, effective August 24, 2025[3][4] Business and Financial Highlights Corporate Developments The company was included in the Russell 3000® and Russell 2000® Indexes and completed a smooth CFO transition, with Gilad Mamlok succeeding Eyal Rubin - The company was included in the Russell 3000® and Russell 2000® Indexes at market close on June 27, 2025[7] - Gilad Mamlok has joined the company and is collaborating with outgoing CFO Eyal Rubin to ensure a smooth transition, with Eyal Rubin providing support until October 2025[4][5] Clinical and Regulatory Progress The European Medicines Agency (EMA) is evaluating Chiesi's Elfabrio® label change application to include a 2 mg/kg dose every four weeks for adult Fabry disease patients - The European Medicines Agency (EMA) is evaluating Chiesi's application for an Elfabrio® label change to include a 2 mg/kg dose every four weeks for adult Fabry disease patients[7] - This label change application was accepted for review in December 2024[7] Financial Performance Analysis In Q2 2025, the company's revenues from product sales grew 16% year-over-year, R&D expenses surged 100% due to PRX-115 trial preparations, and net income turned profitable Revenue Breakdown Company Q2 revenues from product sales increased 16% year-over-year, primarily driven by higher sales to Chiesi, while license and R&D services revenue remained stable | Revenue Type | Q2 2025 (million USD) | Q2 2024 (million USD) | Y-o-Y Change (%) | | :------------------------- | :-------------------- | :-------------------- | :--------------- | | Revenues from Product Sales | 15.4 | 13.3 | 16% | | License and R&D Services Revenue | 0.2 | 0.2 | 0% | - The increase in revenues from product sales was primarily due to an $8.0 million increase in sales to Chiesi, partially offset by a $4.7 million decrease in sales to Fiocruz (Brazil) and a $1.2 million decrease in sales to Pfizer[7] - License and R&D services revenue is expected to remain minimal, excluding potential regulatory milestone payments[7] Operating Expenses Q2 cost of goods sold decreased by 38%, R&D expenses surged 100% due to PRX-115 clinical trial preparations, and SG&A expenses declined by 26% | Expense Type | Q2 2025 (million USD) | Q2 2024 (million USD) | Y-o-Y Change (%) | | :--------------------------------- | :-------------------- | :-------------------- | :--------------- | | Cost of Goods Sold | 5.9 | 9.5 | -38% | | Research and Development Expenses | 6.0 | 3.0 | 100% | | Selling, General and Administrative Expenses | 2.6 | 3.5 | -26% | - The decrease in cost of goods sold was primarily due to reduced sales to Pfizer and Fiocruz (Brazil), partially offset by increased sales to Chiesi[7] - The increase in R&D expenses primarily stemmed from preparations for the planned Phase II clinical trial for PRX-115, with R&D expenses expected to continue to increase significantly as product candidates advance into later-stage clinical trials[7][8] - The decrease in selling, general and administrative expenses was mainly due to a $0.6 million reduction in salaries and related expenses and a $0.3 million decrease in selling expenses[9] Net Income, EPS, and Cash Position The company achieved net income of $0.164 million and $0.00 EPS in Q2 2025, holding $33.4 million in cash and cash equivalents and short-term bank deposits | Metric | Q2 2025 | Q2 2024 | | :------------------------------- | :------------- | :------------- | | Net Income (Loss) | $0.164 million | ($2.20 million) | | Earnings Per Share (Basic and Diluted) | $0.00 | ($0.03) | - As of June 30, 2025, the company held $33.4 million in cash and cash equivalents and short-term bank deposits[9] Tax Implications Q2 tax expenses were $0.5 million, primarily due to GILTI income and TCJA Section 174, with the company evaluating the impact of the H.R.1 bill | Metric | Q2 2025 | Q2 2024 | | :------------------ | :------------- | :------------- | | Tax Expenses (Benefit) | $0.5 million | ($0.1 million) | - Tax expenses primarily resulted from GILTI income and the impact of Section 174 of the U.S. Tax Cuts and Jobs Act (TCJA), which requires capitalization and amortization of R&D expenses[9] - The H.R.1 bill, passed on July 4, 2025, reinstated current deductions for domestic R&D expenditures, and the company is evaluating the new legislation's impact on its consolidated financial statements[9] Company Profile and Outlook About Protalix BioTherapeutics Protalix is a biopharmaceutical company focused on developing and commercializing recombinant therapeutic proteins using its proprietary ProCellEx® plant cell expression system, with FDA approval, partnerships with Pfizer and Chiesi, and a pipeline including PRX-115 and PRX-119 - Protalix is a biopharmaceutical company focused on developing and commercializing recombinant therapeutic proteins through its proprietary ProCellEx® plant cell expression system[12] - The company is the first to receive U.S. FDA approval for a protein produced through a plant cell suspension expression system[12] - Protalix licensed global development and commercialization rights for taliglucerase alfa, for Gaucher disease, to Pfizer, retaining full rights in Brazil; its second product, Elfabrio®, received FDA and EMA approval in May 2023, and is partnered with Chiesi Farmaceutici S.p.A. for global development and commercialization[12][13] - The company's development pipeline includes product candidates such as PRX-115 for uncontrolled gout and PRX-119 for NETs-related diseases[13] Forward-Looking Statements and Risks This press release contains forward-looking statements subject to known and unknown risks and uncertainties that could cause actual results to differ materially from expectations, including commercialization risks for Elfabrio®, market acceptance, competition, regulatory actions, impact of the Israeli regional conflict on operations, clinical trial failures or delays, and global economic conditions - Non-historical statements in this press release are forward-looking statements, subject to known and unknown risks and uncertainties that could cause future actual experiences and results to differ materially from those expressed[14] - Key risks include those related to Elfabrio® commercialization (market acceptance, competition, reimbursement, and regulatory actions, including a black box warning in FDA approval), potential disruptions to company operations from the Israeli regional conflict, regulatory approval and commercial success risks for other products and candidates, clinical trial failures or delays, and global economic conditions and supply chain challenges[14] - The company undertakes no obligation to update this information unless required by law[15] Financial Statements Consolidated Balance Sheets As of June 30, 2025, total assets were $78.486 million, an increase from December 31, 2024, primarily due to higher trade receivables, with total liabilities slightly decreasing and shareholders' equity increasing Summary of Consolidated Balance Sheets (in thousand USD) | Metric | June 30, 2025 | December 31, 2024 | | :------------------------------- | :------------ | :---------------- | | Assets: | | | | Cash and Cash Equivalents | 17,895 | 19,760 | | Short-term Bank Deposits | 15,503 | 15,070 | | Trade Receivables | 9,443 | 2,909 | | Inventories | 21,131 | 21,243 | | Total Current Assets | 65,485 | 60,078 | | Total Assets | 78,486 | 73,417 | | Liabilities and Shareholders' Equity: | | | | Total Current Liabilities | 24,091 | 25,621 | | Total Liabilities | 28,583 | 30,206 | | Shareholders' Equity | 49,903 | 43,211 | Condensed Consolidated Statements of Operations In Q2 2025, total revenue was $15.658 million, with net income of $0.164 million and $0.00 EPS, a significant improvement from the prior year's net loss of $2.203 million and $0.03 loss per share Summary of Condensed Consolidated Statements of Operations (in thousand USD, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :------------------------------- | :------ | :------ | :------ | :------ | | Revenues from Product Sales | 15,440 | 13,304 | 25,435 | 16,981 | | License and R&D Services Revenue | 218 | 170 | 336 | 241 | | Total Revenues | 15,658 | 13,474 | 25,771 | 17,222 | | Cost of Goods Sold | (5,870) | (9,456) | (14,050) | (12,058) | | Research and Development Expenses | (5,992) | (2,961) | (9,467) | (5,848) | | Selling, General and Administrative Expenses | (2,624) | (3,484) | (5,227) | (6,599) | | Operating Income (Loss) | 1,172 | (2,427) | (2,973) | (7,283) | | Financial Expenses (Income), Net | (511) | 155 | (98) | 278 | | Tax Expenses (Benefit) | 497 | (69) | 384 | (207) | | Net Income (Loss) | 164 | (2,203) | (3,455) | (6,798) | | Earnings (Loss) Per Share - Basic | 0.00 | (0.03) | (0.04) | (0.09) | | Earnings (Loss) Per Share - Diluted | 0.00 | (0.03) | (0.04) | (0.09) | Additional Information Conference Call and Webcast Details Protalix BioTherapeutics hosted a conference call and webcast on August 14, 2025, to discuss financial results and provide business updates, with detailed participation and replay information provided Conference Call Details | Date: | August 14, 2025, Thursday | | :------------ | :------------------------ | | Time: | 8:30 AM ET | | Toll-Free: | 1-877-423-9813 | | International: | 1-201-689-8573 | | Conference ID: | 13755073 | Webcast Details | Company Link: | https://ir.protalix.com/news-events/events | | :-------------- | :--------------------------------------- | | Webcast Link: | https://tinyurl.com/yc272tbr | | Conference ID: | 13755073 | - A replay of the conference call will be available for two weeks in the investor section's events calendar on the company's website[11] Investor Contact Investor relations contact information is provided for inquiries - Investor Contact: Mike Moyer, Managing Director, LifeSci Advisors[16] - Contact Phone: +1-617-308-4306, Email: mmoyer@lifesciadvisors.com[16]