Protalix Revenue Jumps 16 Percent in Q2

Protalix BioTherapeutics (PLX -1.83%), a biopharmaceutical company specializing in plant cell-based protein production, announced its second quarter results on August 14, 2025. Revenues from product sales grew 16% to $15.4 million compared to Q2 2024. GAAP revenue of $15.6 million was slightly ahead of the $15.53 million analyst estimate. Despite this top-line beat, the company reported GAAP earnings per share (EPS) of $0.00, missing analyst expectations of $0.04 GAAP EPS. The result was influenced by a significant increase in research and development costs as the company prepared for a key clinical trial. Overall, the quarter showed strong commercial traction for Elfabrio®, gains in gross profit, and a return to quarterly profitability (GAAP).

Source: Analyst estimates for the quarter provided by FactSet.

Company Overview and Strategic Focus

Protalix BioTherapeutics develops and markets enzyme replacement therapies using its proprietary ProCellEx technology, a plant cell-based system for manufacturing complex proteins. This technology supports its two commercial enzyme replacement therapy (ERT) products: Elfabrio, for Fabry disease, and Elelyso, for Gaucher disease. Both address rare genetic disorders by replacing missing enzymes in patients. The company is also advancing new drug candidates, with its most developed pipeline asset being PRX-115 for uncontrolled gout.

The ProCellEx platform remains at the heart of Protalix's competitiveness. It allows for scalable, flexible protein manufacturing and offers potential safety and cost benefits over traditional approaches. The company's recent business efforts have centered on scaling Elfabrio sales globally through its partnership with Chiesi and progressing clinical trials for new indications. Key success factors include successful commercialization of current therapies, advancing the pipeline, managing costs, and maintaining productive strategic partnerships.

Quarter in Review: Product Sales, Pipeline Progress, and Financial Shifts

Sales momentum remained strong, led by a substantial increase in Elfabrio enzyme therapy shipments. Sales to Chiesi, the global commercialization partner for Elfabrio, grew by $8.0 million versus Q2 2024, highlighting robust early demand and successful commercial execution. Management called this out as a highlight, stating sales performance was “beyond our expectations.” Shipments to Fiocruz (Brazil) fell by $4.7 million, and Sales to Pfizer dropped by $1.2 million. Despite these declines, overall goods revenue from commercial products increased 16% year over year, underscoring the growing importance of Elfabrio to the business.

This improvement was supported by higher product revenue and a sharp 38% drop in cost of goods sold, driven by reduced sales to lower-margin legacy markets (Pfizer and Fiocruz). Operating income (GAAP) swung to $1.2 million from a prior-year operating loss

The company's research and development spending jumped to $6.0 million, Research and development spending increased by 100% to $6.0 million for the three months ended June 30, 2025, compared to $3.0 million in the prior-year period. This was primarily due to preparations for a phase II clinical trial of PRX-115, a biologic drug candidate targeting uncontrolled gout. This molecule aims to address a form of gout that does not respond to typical therapies, potentially opening up a valuable new indication. The investment in pipeline advancement contributed to the quarter’s earnings miss, but reflects the company’s strategy of expanding its therapeutic reach over time. Notably, selling, general, and administrative expenses declined 26% to $2.6 million, showing restraint on non-R&D costs.

During the period, Protalix continued to benefit from its strategic collaboration with Chiesi. The company expects milestone payments from this agreement to be a key driver of future revenue, with remaining regulatory milestone payments described as "milestone by milestone" and potentially up to $75 million, depending on achievement of specific regulatory events, with up to $500 million possible over time tied to commercial and regulatory goals, as referenced in management commentary regarding the aggregate potential milestone payments. However, management stated that ongoing license and research revenue outside of these milestones will remain minimal. On the regulatory front, the company noted the ongoing review at the European Medicines Agency for a proposed change to the Elfabrio dosing schedule, with the submission accepted for review in December 2024. The European Medicines Agency is reviewing the proposed change to the Elfabrio dosing schedule. There was also a key management announcement: Gilad Mamlok will succeed Eyal Rubin as Chief Financial Officer, with a transition planned to help ensure continuity.

Product Portfolio and Key Assets

Elfabrio is an enzyme replacement therapy designed for the treatment of Fabry disease, a rare inherited disorder. Commercial launch momentum for this therapy is driving current revenue growth, especially through global sales booked by Chiesi. Elelyso, another enzyme replacement therapy, targets Gaucher disease, but sales from this program declined.

On the research side, PRX-115 is a biologic candidate expected to enter a phase II trial for uncontrolled gout in the second half of 2025, with first patient dosing planned for the fourth quarter. Development of other early-stage candidates, such as PRX-119 for diseases linked to neutrophil extracellular traps, continued but did not materially affect financials. Protalix’s core technology platform, ProCellEx, underpins both the current commercialized products and pipeline molecules by supporting plant-based production of recombinant proteins. This platform is a strategic differentiator in biologics manufacturing by offering flexible and potentially safer processes than mammalian cell systems.

Looking Ahead: Management Outlook and Key Watch Areas

Management did not provide explicit forward guidance for future revenue or earnings. Instead, it reiterated confidence in Elfabrio’s long-term sales outlook and noted that fluctuations in revenue may continue as inventory orders normalize following product launch. The company expects research and development expenses to remain elevated as it advances its pipeline programs, particularly with the initiation of the PRX-115 phase II clinical trial.

For future quarters, critical watch points include progress on the Elfabrio European label application, evolving sales patterns for both commercial products, and execution through the CFO transition. Investors should also note that potential milestone-related revenues may cause variability in reported results depending on product and regulatory achievements.

PLX does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.