Core Viewpoint - Protalix BioTherapeutics reported a significant increase in revenues driven by the sales of Elfabrio® and provided updates on its product pipeline and management changes [2][4][6]. Financial Highlights - Revenues from selling goods for Q2 2025 were $15.4 million, a 16% increase from $13.3 million in Q2 2024, primarily due to an $8.0 million increase in sales to Chiesi [6][7]. - Cost of goods sold decreased by 38% to $5.9 million in Q2 2025 from $9.5 million in Q2 2024 [7]. - Research and development expenses doubled to approximately $6.0 million in Q2 2025 from $3.0 million in Q2 2024, mainly due to preparations for the Phase 2 trial of PRX-115 [7][17]. - Selling, general, and administrative expenses decreased by 26% to $2.6 million in Q2 2025 from $3.5 million in Q2 2024 [7]. - The net income for Q2 2025 was approximately $164,000, compared to a net loss of $2.2 million in Q2 2024 [7][17]. Business Updates - Protalix is advancing the development of PRX-115, with a Phase 2 trial expected to start in the second half of 2025 [2][4]. - The company appointed Gilad Mamlok as the new Chief Financial Officer, succeeding Eyal Rubin, who will assist during the transition until October 2025 [3][6]. - Protalix has been added to the Russell 3000® and Russell 2000® Indexes as of June 27, 2025 [6]. Product Pipeline - Elfabrio® is positioned for growth in the Fabry disease market, which is currently valued at approximately $2.3 billion and is expected to grow to $3.2 billion by 2030 [2][12]. - The European Medicines Agency is reviewing a submission for a new dosing regimen for Elfabrio® [6].

Core Viewpoint - Protalix BioTherapeutics, Inc. will release its financial results for the quarter ended June 30, 2025, and provide a business and clinical update on August 14, 2025 [1] Group 1: Financial Results and Conference Call - The management will host a conference call to discuss the financial results and provide updates on recent corporate and regulatory developments [2] - The conference call is scheduled for August 14, 2025, at 8:30 a.m. EDT [3] Group 2: Webcast and Participation Details - The conference will be webcast live from the Protalix website, and participants are encouraged to access the call at least 15 minutes early [4] - A replay of the call will be available for two weeks on the Events Calendar of the Company's website [4] Group 3: Company Overview - Protalix is focused on the development and commercialization of recombinant therapeutic proteins using its proprietary ProCellEx plant cell-based expression system [5] - The company has FDA approval for its first product, taliglucerase alfa, for the treatment of Gaucher disease, and its second product, Elfabrio®, was approved in May 2023 [5][6] - Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio [6]

Core Viewpoint - Protalix BioTherapeutics reported strong financial results for Q1 2025, with significant revenue growth driven by increased sales, and is advancing its clinical pipeline, particularly focusing on the gout treatment candidate PRX-115 [2][7][14]. Financial Highlights - Revenues from selling goods reached $10.0 million for the three months ended March 31, 2025, an increase of $6.3 million, or 170%, compared to $3.7 million for the same period in 2024 [7]. - Revenues from license and R&D services were $0.1 million for both Q1 2025 and Q1 2024, primarily from agreements with Chiesi [7]. - Cost of goods sold was $8.2 million for Q1 2025, up $5.6 million, or 215%, from $2.6 million in Q1 2024 [7]. - Total research and development expenses were approximately $3.5 million for Q1 2025, a 21% increase from $2.9 million in Q1 2024 [8][13]. - The net loss for Q1 2025 was approximately $3.6 million, or $0.05 per share, compared to a net loss of $4.6 million, or $0.06 per share, for the same period in 2024 [13][20]. Clinical and Pipeline Developments - Protalix is preparing to initiate a phase II clinical trial for PRX-115, a treatment for uncontrolled gout, later in 2025, following promising results from a phase I trial completed in 2024 [2][6]. - The preliminary results of the phase I trial indicated that PRX-115 has the potential for effective uric acid-lowering treatment with a wide dosing interval [6]. - The company is also evaluating additional pipeline candidates, including PRX-119 and various early-stage clinical assets [2]. Partnerships and Collaborations - Protalix has partnered with Chiesi Global Rare Diseases for the global development and commercialization of its products, including Elfabrio® [4][15]. - The company has licensed worldwide development and commercialization rights for taliglucerase alfa to Pfizer Inc. for the treatment of Gaucher disease [14]. Market Presence - Protalix is recognized for its proprietary ProCellEx® plant cell-based protein expression system, which is a novel method for developing recombinant proteins at an industrial scale [14]. - The company has achieved FDA approval for its products, marking significant milestones in its commercialization efforts [14].