Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the Protallix Biotherapeutics Fiscal Year 2023 Financial and Business Results Conference Call. As a reminder, this conference call is being recorded. I'll now turn the conference over to our host, Ms. Lauren Marrick of LifeSci Advisors, Investor Relations for Protallix. You may now begin.

Thank you, Rob, and welcome to the Protallix Biotherapeutics Fiscal Year 2023 Financial Results and Business Update Conference Call. With me today are Dror Boshan, President and CEO of Protallix, and Eyal Rubin, Senior Vice President and Chief Financial Officer. A press release announcing the results and the update was issued this morning and is available now on the Protallix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings released in this teleconference include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in Portalix's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Dror Bashan. Dror?

Thank you, Lorraine, and welcome everyone to our fiscal year 2023 financial results and business update course. I will begin by reviewing our accomplishments over the past year and recent progress. Following my remarks, Eyal will provide a more detailed review of our financial results. We will then open the line for questions. 2023 marked a significant year for Portalix as we received regulatory approvals for our second drug, Elfabrio, for the treatment of adult patients with Fabry disease. In May of 2023, both the FDA and the EMA approved Elfabrio for the treatment of adult patients with Fabry disease. Since then, El Fabrio has been granted additional regulatory approvals in other markets like UK, Switzerland, and most recently in Israel as well. Our commercial partner, Chiesi Global Royal Diseases, remains focused on the commercial launches which are underway in the United States, in the European Union, the UK, and additional markets where approvals are granted. We are confident that Chiesi will continue to position Elfabrio for success, and we look forward to continued growth of Elfabrio's franchise. Elfabrio is now the second approved drug expressed via our proprietary plant called based protein expression system Procelix, which further highlights the success of our unique platform. With these significant milestones behind us, and while we are supporting Chiesi's operations, we are continuing to focus on building the development of our pipeline of innovative assets for the treatment of genetic and non-genetic rare diseases. Our next clinical development candidate is PRX115, which is being developed for the potential treatment of severe gout. PRX115 is a recombinant pegylated uricase product candidate that is also produced using our Procelex platform. In March of 2023, we have initiated a phase one first in human clinical trial of PRX115 to evaluate its safety, pharmacokinetics, pharmacodynamics, and immunogenicity. This is a double-blind placebo-controlled single ascending dose study being conducted in New Zealand in approximately 56 patients with elevated uric acid levels. We are pleased to announce that the trial is now fully enrolled, and we expect to report preliminary results from this study in the second quarter of 2024. Our next pipeline candidate, also being expressed through Porcelix, is PRX119. PRX119 is a pegylated recombinant human DNase-1 candidate in developing for the potential treatment of diseases associated with neutrophil extracellular traps, or NECs. Additional preclinicals are ongoing We will update you accordingly, of course. In addition to PRX115 and PRX119, we have multiple preclinical programs in progress, and we look forward to providing with the updates on these potential development candidates as they become more mature. On the corporate side, in 2023, we welcome Dr. Elliot Forster as chairman of our board of directors and a member of our nominating committee. Dr. Forster is succeeded Ze'ev Braunfeld who retired and we are grateful to Ze'ev for his dedication and leadership since the founding of Protonix. And we are grateful for Elliot's contributions thus far as we prepared for an exciting phase of development of the company. Finally, and before turning the call over to Eyal, I want to note that our strong balance sheet provides us with sufficient cash runway to support our operations And in addition, as Eyal will discuss, sales of a Fabrio to Chiesi increased after regulatory approvals of a Fabrio, while Chiesi builds its inventory to support a successful launch. We expect sales to Chiesi to gradually continue as they anticipate future approvals and launches in additional countries throughout the world. With that, it is now my pleasure to turn the call over to Eyal for a review of our financials And Eyal, please go ahead.