Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to Protallix Biotherapeutics Full Year 2025 Financial Results and Business Update Conference Call. As a reminder, this call is being recorded. I will now turn the conference over to Mike Moyer, Managing Director of LifeSite Advisors and Investor Relations Representative for Protallix. Thank you. You may begin.

Thank you, Operator, and welcome to the Portalix Biotherapeutics Full Year 2025 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO, and also with Portalix, Gilad Mamlok, Senior Vice President and Chief Financial Officer. A press release announcing the financial results and business updates were issued this morning and are available now on the Portalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings released in the teleconference include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause the actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in Fatalex's filings with the Securities and Exchange Commission. I will now turn the call over to Mr. Bashan. Dror?

Thank you, Mike. And thank you everyone for joining this call. Today's discussion will include our forward-looking financial outlook, which emphasizes the strength and durability of our business as we enter 2026. However, I want to first discuss our important recent news. As previously announced, the European Commission has approved the 2 mg per kg every four weeks dosing regimen for El Fabrio for adults living with Fabry disease who are stable with an enzyme replacement therapy. This approval strengthens the treatment landscape for adult patients with Fabry disease across the European Union by introducing an additional dosing regimen that has the potential to enhance long-term management and represent a meaningful advancement, not only for the adults with living Fabry disease, but also for their families. The FDA-approved dosing regimen in the U.S. remains 1 mg per kg every two weeks. Protalyx is proud of this achievement. We also want to thank our partner Chiesi. This achievement is a testament to Chiesi's dedicated efforts and professional execution for which we are most appreciative. The every four weeks approval in the EU entitles us to $25 million regulatory milestone payment from Chiesi. Having earned this milestone, we project a cash balance of approximately $50 million by early April 2026. This enables us to execute comfortably our strategy, including our clinical trials. For 2026, we expect total revenues to range from approximately $78 million to $83 million, including the $25 million milestone payment. This projection includes expected total revenues of approximately $33 to $35 million from Chiesi, excluding milestones, and approximately $20 to $23 million from El Eliza. Gilad will walk through the full financial details later in this call. Operationally, 2025 was a year of consistent execution with our partners. Chiesi continued to perform well across the United States and key ex-US markets, with consistent increasing patient numbers in all markets. The recent approval of the every-four-weeks regimen in Europe significantly enhances El Fabrio's competitive positioning. We remain encouraged by the long-term trajectory of the Fabri market which is projected to reach approximately 3.4 billion by 2030. El Fabrio's differentiated profile and strong commercial execution strengthen its position in the market. Turning to our pipeline, we continue to advance PRX115 with strong momentum. Our phase two trial, our release study, is now enrolling, and the first patients have been randomized. We anticipate top line results in the second half of 2027. Uncontrolled gout remains a high need indication. And we believe that PRX115 has the potential to become a best-in-class therapy and ultimately our third commercial product. We are also expanding our renal pipeline with PRX119, our long-acting DNA candidate, and through our RNA-based collaboration with CECARNA, as well as other programs. With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook. Thank you.