Protalix BioTherapeutics, Inc. (DE)

Good morning, ladies and gentlemen, and welcome to the ProTalix Biotherapeutics Second Quarter 2025 Financial and Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to our host, Mr. Mike Moyer with LifeSci Advisors. You may begin your conference.

Thank you, Operator, and welcome to the ProTalix Biotherapeutics Second Quarter 2025 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO of Portalix, I.L. Rubens, Senior Vice President and Chief Financial Officer. A press release announcing the financial results for the quarter in corporate updates was issued this morning and is now available on the Portalix 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 Bratalex's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Bishan. Sure.

Thank you, Mike, and thank you, everyone, for joining our second quarter of 2025 financial results and business update call. I will begin with... with reviewing our accomplishments over the quarter and recent weeks. Following my remarks, Eyal will provide a detailed review of our financial results. We will then open the line for questions, of course. In the first half of 2025, we experienced a 50% increase in revenues from selling goods compared to the same period last year. Revenue growth was driven primarily by sales of El Fabrio to Chiesi. As you know, Chiesi is an international biopharmaceutical group with 31 affiliates worldwide and a dedicated global rare disease division. They're an ideally suited partner for the commercialization of Elfabrio for Fabry disease, which represents a global market of approximately 2.3 billion US dollars in 2025 and is forecasted to reach approximately 3.2 billion by 2030. As we have discussed in the past, under the terms of our partnership, Chiesi is solely responsible for the commercialization of El Fabrio, including distribution, patient acquisition, retention, and payer reimbursement. And Portalix is responsible for manufacturing and product distribution to Chiesi. Operationally, Chiesi conducts its own internal commercial forecasting to guide its inventory needs, and to date has placed bulk orders with Portalix since regulatory approval for El Fabrio, since it was launched or approval was obtained in 2023. Once a bulk order has been delivered to Chiesi, Portalic recognizes such an order as a sale. Since commercialization of El Fabio is still in early phase of market launch, it is important to emphasize certain aspects of this relationship and how it is expected to function in the near future. In the early phase of the launch, there may be quarter with no bulk orders are made due to inventory destocking. Current ordering patterns are only expected to change once the underlining demand characteristics stabilize and launch matures and market share gradually grows. Orders placed by Chiesi are not made in direct relation to pace of patient acquisition and retention, so they cannot be used as a substitution for estimates of end-user demand for El Fabrio. With that said, I have to emphasize that we continue to anticipate that Fabio O'Reilly is exceeding $100 million by 2030, based on the projected 15% to 20% market share of the estimated 3.2 billion Fabry total market. In addition to these elements, I remind you that last year, in 2024, the European Medicine Agency, EMA, validated PSD's variation submission for Elfabrio label to include a less frequent dosing regimen, once in four weeks, versus the current standard of care, every two weeks dosing regimen, for all current Fabri injectable medications. This variation submission is still under review by CMA. To reiterate, we have a committed partner, and Chiesi has consistently increased its focus on Elfabrio by making substantial investments in medical, regulatory and successful commercialization programs. We continue to appreciate Chiesi partnership and dedication to Fabry disease patients and the patients community. I now turn to our Gout product candidate, PRX115. Given the promising results obtained in 2024 from our first in human study of PRX115, we are focused on building on the momentum and continue to progress towards initiation of a Phase II study in the second half of 2025 and enrollment of the first patient in the fourth quarter. As we announced with our results for 2024, the first in-human study involved a single dose of PRX115 in subjects with elevated uric acid levels. The encouraging results from the study suggest a long-acting effect and the potential of widening the dose interval, which would enhance patients' compliance, and treatment flexibility. As we have been discussing throughout the past year, our R&D efforts are focused on early-stage development assets to build our product development pipeline. This includes leveraging our prosthetics platform and regulation capabilities, evaluating drug delivery systems that may allow protective delivery of different modalities, and focusing on therapeutic areas for renal rare disease. These efforts will continue throughout 2025, and we intend to provide further updates as these programs mature. We are excited about the groundwork, and we are laying for future developments. Before turning the call over to Eyal for a review of our financials, I will close my remarks with a personal note. As we recently announced, Eyal is stepping down as our Chief Financial Officer after six years of dedicated service to Protanx. And Eyal and I worked closely and collaboratively on Protalic's successful transformation. We contributed greatly to the strengthening of the company's capital and preparing us for future growth. On behalf of the board and the Protalic family, we thank Eyal for all the contributions and wish him continued and well-earned success in the future. As we have previously announced, Eyal is to be succeeded by Gilad Mablo. Gilad is a seasoned financial executive with deep experience in healthcare and technology companies and has an extensive background in capital markets, transactions, mergers, acquisitions, and business development. We are happy to welcome Gilad to the team and have every confidence that he will play an important role in Portalix management as we continue to work towards future growth. Eyal, now it's your turn, please.