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 Protalix; Eyal Rubin, Senior Vice President and Chief Financial Officer. A press release announcing the financial results for the quarter and corporate updates was issued this morning and is now available on the Protalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings release and 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 Protalix's filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Bashan. Dror?

Thank you, Mike, and thank you, everyone, for joining our second quarter 2025 financial results and business update call. I will begin 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 Elfabrio 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 USD 2.3 billion in 2025 and is forecasted to reach approximately USD 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 Elfabrio, including distribution, patient acquisition, retention and payer reimbursement. And Protalix 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 Protalix since regulatory approval for Elfabrio since it was launched or approval was obtained in 2023. Once a bulk order has been delivered to Chiesi, Protalix recognizes such an order as a sale. Since commercialization of Elfabrio 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 quarters with no bulk orders are made due to inventory destocking. Current ordering patterns are only expected…

Thank you, Dror, for your very kind words. It has been a pleasure to work with you these last years. I'm sure that under the continued leadership and with the support of Gilad, my very capable successor, Protalix has a bright future. Protalix's financial management will be in good hands under his leadership. With that, I will now review our second quarter 2025 financials. We recorded revenues from selling goods of $15.4 million during the 3 months ended June 30, 2025, an increase of $2.1 million or 16% compared to revenues of $13.3 million for the 3 months ended June 30, 2024. The increase resulted primarily from an increase of $8 million in sales to Chiesi, partially offset by a decrease of $4.7 million in sales to Brazil, which is a timing difference, and $1.2 million in sales to Pfizer. Revenues from license and R&D services were $0.2 million for the 3 months ended June 30, 2025, and June 30, 2024. Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with our agreement with Chiesi. We expect to generate minimal revenues from license and R&D services other than potential regulatory milestone payments. Cost of goods sold was $5.9 million for the 3 months ended June 30, 2025, a decrease of $3.6 million or 38%, from cost of goods sold of $9.5 million for the 3 months ended June 30, 2024. The decrease in cost of goods sold was primarily the result of a decrease in sales to Pfizer in Fiocruz Brazil, partially offset by the increase in sales to Chiesi. For the 3 months ended June 30, 2025, our total research and development expenses were approximately $6 million comprised of approximately $3 million subcontractor-related expenses, approximately $2 million in salary and related expenses, approximately…

Thank you, Eyal. Again, we appreciate everything you have done for Protalix. To conclude, for the first half of 2025, we continued to execute our strategic plan and build for the foundation of our future. We are excited to begin a Phase II program for PRX-115 later this year and to making progress on our early-stage R&D efforts. I'm confident that our strategy, balance sheet and streams of revenue will create value for the stockholders. We look forward to updating you on our progress as we continue to drive innovation and create long-term value for both patients and stockholders. Now I will turn to the operator to open the call for questions, please.

[Operator Instructions] The first question is from John Vandermosten from Zacks SCR.

Great. And welcome to the CFO seat, Gilad. And best wishes, Eyal, and it seems like a long, long time since we first met back in New York, pre-COVID. A world away, definitely. Thought I'd start out with a question on Chiesi. It looks like they started -- or are planning to launch a study called PEGASO. I guess, the way I see it, maybe it's a Phase IV trial or something for Elfabrio, looks at real-world setting use of the product. Any comments on that on how that trial, what its objectives are?

So John, this is part of their Phase IV program in order to enhance, I would say, the merits and strengths of the program. Once we will have, of course, outcomes, we will continue, of course, to update.

Okay. And second question is on the 115 program. I know you're going to start the Phase II pretty soon and then also, I think, try to enroll it before the end of the year. How many sites do you expect for that trial? And what -- any other detail that you can provide on how that's going to be structured? And I'll take my answers offline.

Sure, it's okay. So we plan a couple of dozens of sites. It depends. We will operate mainly -- or most of the sites supposed to be in the U.S., I would say, between 20 to 30 sites overall. And a couple of sites will be outside the U.S. As we will start recruitment, we'll see if we need to expand it or we are okay with 20 or 25, or give or take, this number. Right now, we open, I think, 25, I mean, as a plan. John?

Looks like he disconnected. We can go to the next question. The next question is from Robert Raju (sic) [ Ram Selvaraju ] from H.C. Wainwright.

This is Dan on for Ram. Just wanted to say good luck to Eyal. I haven't been here for very long, but it's been a lot of fun. So basically kind of curious, has Chiesi mentioned what percentage of the market share they hold in Fabry disease? Or do you guys have an indication on that? And does Chiesi have any specific market strategies in place currently to expand Elfabrio sales? If so, what are those? And I'd like to ask a follow-up, if I could.

So first, thank you for that. I think we have discussed we have an agreement in place with Chiesi. We do not disclose number of patients and/or market share, and we respect that, of course. I can assure you, and we say it again and again, not only on earnings call, Chiesi does well on the marketplace, actually better than we expect. We continue to see growth of patient acquisition and actually a significant growth. And as time goes by, they grow their market share. And I assume going back to what I've said at the beginning that, within 1 year, 1.5 years, we will see something which is much more gradually growth than fluctuations of sales from Protalix to Chiesi's inventory.

All right. And during your opening remarks, maybe I'm reading into this a little bit, but you mentioned that Gilad has significant experience in business development and mergers and acquisitions. Could you expand on how Protalix might utilize this experience to that degree?

Again, can you repeat the last sentence?

Just can you expand on how Protalix might utilize his experience in that avenue of, I guess, general interest in business development and mergers and acquisitions?

So I would like to add. Gilad brings, I would say, deep experience or vast experience in multiple aspects and discipline of financial and business activity and know-how and knowledge. Protalix right now is not planning, as far as I know, any mergers and acquisitions. We are focusing on growing our pipeline right now. If there will be a small licensing deal, it would be very small. We are not going to -- I mean, unless there will be an opportunity. I'm not familiar at this stage. I would like to explain, we are not opening now with avenue of mergers and acquisitions. This is not the case. We will grow our company through internal, and I would say, inorganic, hopefully, a couple of programs, but it will be done in a gradually and responsible manner. This does not mean that Gilad or anyone else on the management does not have experience in business development and mergers, but let's leave these big words. We are not in a situation and we -- I hope we operate in a responsible and rational way and we're not going to risk the company. It will not happen.

[Operator Instructions] The next question is from [ Dara Barshes ], a private investor.

Eyal, thank you so much for your dedicated service over the past 6 years. We appreciate it. And can you please give me an idea of what the remaining value of our contract with Chiesi is, please?

So other than -- a, the numbers were never public, but just to give a sense and since it's in our presentation and I've mentioned it on calls, other than the royalties, which as Dror mentioned and we have it also in our presentation, we believe that the sales to Chiesi are going to exceed $100 million by 2030. On the regulatory and commercial milestones, we believe, again, based on the projected 2030 market and based on their penetration and the market share that they are sharing with us, the forecasted market share they are sharing with us, we believe that Protalix can be entitled up to $0.5 billion in milestones, both commercial and regulatory. But again, it's far out. We're talking about by 2030 and it all depends on the market and the penetration. But those can be achievable numbers.

There are no further questions at this time. I would like to turn the floor back over to Dror Bashan for closing comments.

Thank you. So thank you all for joining the call today. We truly appreciate your trust and continued support of shareholders, and we look forward to keeping you updated on our progress in the future, of course. So thank you very much.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.