Protalix BioTherapeutics, Inc. Q2 FY2025 Earnings Call

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 are 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. 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 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 the 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 due to inventory destocking. Current ordering patterns are only expected to change once the underlying demand characteristics stabilize, the launch matures, and market share gradually grows. Orders placed by Chiesi are not made in direct relation to the pace of patient acquisition and retention, so they cannot be used as a substitution for estimates of end-user demand for Elfabrio. With that said, I have to emphasize that we continue to anticipate Elfabrio royalties 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 late last year, in 2024, the European Medicine Agency, EMA, validated Chiesi's variation submission for Elfabrio's label to include a less frequent dosing regimen, once every 4 weeks, versus the current standard of care every 2 weeks dosing regimen for all current Fabry injectable medications. This variation submission is still under review by the EMA. 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's partnership and dedication to Fabry disease patients and the patient community. I now turn to our gout product candidate, PRX-115. Given the promising results obtained in 2024 from our first-in-human study of PRX-115, 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 PRX-115 in subjects with elevated uric acid levels. The encouraging results from the study suggest a long-acting effect and the potential for 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 Protalix platform and PEGylation capabilities, evaluating drug delivery systems that may allow prospective delivery of different modalities, and focusing on therapeutic areas for renal rare diseases. These efforts will continue throughout 2025, and we intend to provide further updates as these programs mature. We are excited about the groundwork 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 6 years of dedicated service to Protalix. Eyal and I worked closely and collaboratively on Protalix's successful transformation. We contributed greatly to strengthening the company's capital and preparing us for future growth. On behalf of the Board and the Protalix family, we thank Eyal for all his contributions and wish him continued and well-earned success in the future. As we have previously announced, Eyal is to be succeeded by Gilad Mamlok. 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 Protalix management as we continue to work towards future growth. Eyal, now it's your turn, please.

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 in subcontractor-related expenses, approximately $2 million in salary and related expenses, approximately $0.2 million of materials-related expenses, and approximately $0.8 million of other expenses. For the 3 months ended June 30, 2024, our total research and development expenses were approximately $3 million, comprised of approximately $1.6 million of salary and related expenses, approximately $0.5 million in subcontractor-related expenses, approximately $0.2 million of materials-related expenses, and approximately $0.7 million of other expenses. The total increase in research and development for the 3 months ended June 30, 2025, was $3 million or 100% compared to research and development expenses of $3 million for the 3 months ended June 30, 2024. The increase in research and development expenses resulted primarily from preparations for the planned Phase II clinical trial of PRX-115. We expect to continue to incur significant increases in research and development expenses as we enter into a more advanced stage of preclinical and clinical trials for certain of our product candidates. Selling, general and administrative expenses were $2.6 million for the 3 months ended June 30, 2025, a decrease of $0.9 million or 26% compared to $3.5 million for the 3 months ended June 30, 2024. The decrease resulted primarily from a decrease of $0.6 million in salary and related expenses and a decrease of $0.3 million in selling expenses. Financial expenses, net, were $0.5 million for the 3 months ended June 30, 2025, compared to financial income net of $0.2 million for the 3 months ended June 30, 2024. The increase in financial expenses net resulted primarily from exchange rate costs and lower interest income on bank deposits, partially offset by lower notes interest expenses due to the September 2024 repayment in full of all the outstanding principal and interest payable under the convertible promissory notes that were then outstanding. We recorded tax expenses of approximately $0.5 million for the 3 months ended June 30, 2025, compared to a tax benefit of approximately $0.1 million for the 3 months ended June 30, 2024. Tax expenses or benefit resulted primarily from taxes on income mainly derived from GILTI income, mainly in respect of Section 174 of the U.S. Tax Cuts and Jobs Act of 2017, the TCJA. Effective in 2022, Section 174 of the TCJA requires all U.S. companies, for tax purposes, to capitalize and subsequently amortize R&D expenses that fall within the scope of Section 174 over 5 years for research activity conducted in the United States and over 15 years for research activity conducted outside the United States, rather than deducting such costs in the current year. On July 4, 2025, tax reform legislation was enacted in the United States through the passage of H.R.1, The One Big Beautiful Bill Act, which includes significant corporate tax changes, including a restoration of the current deductibility for domestic research expenditures beginning in 2025, with transition options for previously capitalized amounts. We continue to evaluate the impact that the new legislation will have on the consolidated financial statements. At June 30, 2025, we had $33.4 million in cash and cash equivalents and short-term bank deposits. Net income for the 3 months ended June 30, 2025, was approximately $164,000 or $0 per share basic and diluted, compared to a net loss of approximately $2.2 million or $0.03 per share basic and diluted for the same period in 2024. In closing, I wish to extend my sincere thanks to the many investors and stakeholders in Protalix that have supported us in the last 6 years. It has been an honor to work with you all. I will now turn the call back to you, Dror.

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 a foundation for our future. We are excited to begin a Phase II program for PRX-115 later this year and to make 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.

The first question is from John Vandermosten from Zacks SCR.

Great. Welcome to the CFO seat, Gilad, and best wishes, Eyal. It feels like a long time since we first met in New York before COVID. I would like to start with a question about Chiesi. It seems they have either started or plan to launch a study called PEGASO. From my perspective, it appears to be a Phase IV trial for Elfabrio, focusing on the product's use in a real-world setting. Could you share any insights on that trial and its objectives?

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 have, of course, outcomes, we will continue to update.

Okay. My second question is about the 115 program. I understand that you'll begin Phase II soon and aim to enroll participants before the year concludes. How many sites do you anticipate for that trial? Additionally, could you provide more details on its structure? I'll wait for my answers offline.

We plan to establish around 20 to 30 sites, with most of them located in the U.S. A few sites will be outside the U.S. As we begin recruitment, we will assess if we need to adjust the number of sites or if 20 to 25 will suffice. Currently, our target is to open 25 sites.

It seems he has disconnected. We can move on to the next question. The next question comes from Robert Raju 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 the 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 calls, Chiesi is doing well in the marketplace, actually better than we expect. We continue to see growth in patient acquisition and actually a significant growth. As time goes by, they are growing 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 gradual 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?

I would like to add that Gilad has extensive experience in various areas of financial and business activities. Currently, Protalix is not planning any mergers or acquisitions as far as I know; our focus is on growing our pipeline. If there were to be any minor licensing deal, it would be quite small. We are not currently exploring mergers and acquisitions. We intend to grow our company through internal efforts and hopefully a few programs, but this will be done in a gradual and responsible way. This does not imply that Gilad or anyone else in management lacks experience in business development and mergers. However, let’s not get carried away with those concepts. We are not in a position to pursue such options, and I hope we operate in a responsible manner without putting the company at risk. This will not happen.

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 the royalties, which, as Dror mentioned, and we have it also in our presentation, we believe that 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 to 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.