Protalix BioTherapeutics - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 total revenue was $15.658M, up 16.3% year over year and up 54.8% quarter over quarter; revenue beat Wall Street consensus of $13.486M by $2.172M. EPS was $0.00 versus $0.03 consensus, a miss; gross margin expanded materially on mix shift toward Chiesi’s Elfabrio.*
• Cost of goods sold fell 38% YoY to $5.870M, driving gross margin to ~62.5% (vs. ~29.8% in Q2 2024) and EBIT margin to ~7.5% (vs. -16.9% YoY), aided by lower Pfizer/Fiocruz sales and higher Chiesi volumes.
• Management reiterated PRX-115 timelines: randomized Phase 2 initiation in H2 2025, with first patient in Q4 2025; EMA continues reviewing Elfabrio label variation for 2 mg/kg every 4 weeks, which could support broader adoption.
• Corporate catalysts include CFO transition to Gilad Mamlok (effective Aug 24, 2025) and Russell 3000/2000 index inclusion as of June 27, 2025, potentially enhancing visibility and liquidity.

What Went Well and What Went Wrong

What Went Well

• Revenue beat and gross margin expansion: “We experienced a 50% increase in revenues from selling goods in the first half of 2025… driven primarily by sales of Elfabrio® to Chiesi… we are confident in the growth of our Elfabrio franchise over the long term.”
• SG&A discipline: SG&A fell 26% YoY to $2.6M, primarily from lower salary and selling expenses, supporting operating leverage as volumes scale.
• Balance sheet strength maintained: Cash and short-term deposits were ~$33.4M at quarter-end, providing funding runway into clinical milestones.

What Went Wrong

• EPS missed consensus ($0.00 vs $0.03) as R&D ramped for PRX-115 Phase 2 and financial expenses rose on FX and lower deposit interest; Q2 financial expenses, net swung to $(0.5)M from +$0.2M YoY.*
• Customer concentration/mix volatility: Q2 increase was driven by +$8.0M to Chiesi, but offset by -$4.7M Fiocruz and -$1.2M Pfizer, highlighting early-launch ordering variability and regional procurement risks.
• Tax headwinds/uncertainty: Q2 tax expense was ~$0.5M versus a $(0.1)M benefit YoY; while U.S. tax reform restored deductibility for domestic research beginning in 2025, management is still evaluating impacts.

Transcript

Speaker 3

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.

Speaker 5

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 BioTherapeutics, and 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 BioTherapeutics 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 BioTherapeutics' filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Bashan.

Speaker 2

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 $2.3 billion 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 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, 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 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 made due to inventory destocking.

Current ordering patterns are only expected to change once the underlying demand characteristics stabilize and launch materials 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 last year in 2024, the European Medicines Agency, EMA, validated Chiesi's variation submission for the 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 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 the initiation of a phase 2 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 of widening the dose interval, which would enhance patient 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 proprietary protein engineering platforms and pegylation capabilities, evaluating drug delivery systems that may allow protective delivery of different modalities, and focusing on therapeutic areas for rare renal diseases. 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 the field 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 Protalix BioTherapeutics. Eyal and I worked closely and collaboratively on Protalix'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 Protalix 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 Mamrouk. 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's management as we continue to work towards future growth.

Eyal, now it's your turn, please.

Speaker 1

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 BioTherapeutics has a bright future. Protalix BioTherapeutics'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 three-month end of June 30, 2025, an increase of $2.1 million or 16% compared to revenues of $13.3 million for the three-month end of 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 licensed and R&D services were $0.2 million for the three-month end of June 30, 2025 and June 30, 2024. Revenues from licensed and R&D services are comprised primarily of revenues we recognize in connection with our agreements with Chiesi. We expect to generate minimal revenues from licensed and R&D services other than potential regulatory milestone payments. Cost of goods sold was $5.9 million for the three-month end of June 30, 2025, a decrease of $3.6 million or 38% from cost of goods sold of $9.5 million for the three-month end of June 30, 2024. The decrease in cost of goods sold was primarily the result of the decrease in sales to Pfizer in Fiocruz, Brazil, partially offset by the increase in sales to Chiesi.

For the three-month end of 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 $0.2 million of materials-related expenses, and approximately $0.8 million of other expenses. For the three-month end of 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 three-month end of June 30, 2025 was $3 million or 100% compared to research and development expenses of $3 million for the three-month end of June 30, 2024. The increase in research and development expenses resulted primarily from preparations for the planned phase 2 clinical trial of PRX-115.

We expect to continue to increase a significant increase 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 three-month end of June 30, 2025, a decrease of $0.9 million or 26% compared to $3.5 million for the three-month end of 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 was $0.5 million for the three-month end of June 30, 2025, compared to financial income net of $0.2 million for the three-month end of June 30, 2024.

The increase in financial expenses net resulted primarily from exchange rate costs and low 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 three-month end of June 30, 2025, compared to a tax benefit of approximately $0.1 million for the three-month end of June 30, 2024. Tax expenses or benefit resulted primarily from taxes and income merely 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 five years for research activities conducted in the United States and over 15 years for research activities 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 HR1, the One Big Beautiful Bill Act, which includes significant corporate tax changes, including a restoration of the current deductibility for domestic research expenditure beginning in 2025, with transition options for previously capitalized amounts. We continue to evaluate the impact that new legislation will have on the consolidated financial statements. As of June 30, 2025, we had $33.4 million in cash and cash equivalents and short-term deposits.

Net income for the three 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 BioTherapeutics that have supported us the last six years. It has been an honor to work with you all. I will now turn the call back to you, Dror.

Speaker 2

Thank you, Eyal. Again, we appreciate everything you have done for Protalix BioTherapeutics. To conclude, for the first half of 2025, we continue to execute our strategic plan and build for the foundation of our future. We are excited to begin a phase 2 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 three 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 the operator to open the call for questions, please.

Speaker 3

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. The first question is from John Vandermosten from Zacks Investment Research. Please go ahead.

Speaker 4

Great, thank you. Welcome to the CFO seat, Gilad, and best wishes to you all. It seems like a long, long time since we first met, back in New York, pre-COVID, a world away, definitely. I thought I'd start out with a question on Chiesi. It looks like they started or are planning to launch a study called PAGASO. I guess the way I see it, maybe it's a phase 4 trial or something for Elfabrio. It looks at real-world setting use of the product. Any comments on that, on how that trial, you know, what its objectives are?

Speaker 2

You know, John, this is part of their phase 4 program 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.

Speaker 4

Okay. Second question is on the 115 program. You're going to start a phase 2 pretty soon and then also, I think, try to enroll before the end of the year. How many sites do you expect for that trial and what, you know, any other detail that you can provide on how that's going to be structured? I'll take my answers offline. Thank you, Dror.

Speaker 2

Sure, it's okay. We plan a couple of dozens of sites. It depends. We will operate mainly, or most of the sites are 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 will see if we need to expand it or we are okay with 20 or 25 or, you know, give or take this number. Right now, we open, I think, 25, I mean, as a plan. John?

Speaker 3

Looks like he disconnected. We can go to the next question. The next question is from Ram Selvaraju from H.C. Wainwright. Please go ahead.

Speaker 0

Good morning. This is Dan Al-Farram. Thanks for taking our questions. I just wanted to say good luck to you all. I haven't been here for very long, but it's been a lot of fun. Basically, kind of curious, has Chiesi mentioned what % of the market share they hold in Fabry disease? Do you guys have an indication on that? Does Chiesi have any specific market strategies in place currently to expand Elfabrio sales? If so, what are those? I'd like to ask a follow-up if I could.

Speaker 2

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 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. As time goes by, they grow their market share. I assume, going back to what I've said at the beginning, that within a year, a year and a half, we'll see something which is much more gradually growth than fluctuations of sales from Protalix to Chiesi's inventory.

Speaker 0

All right, thank you for that. 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 BioTherapeutics might utilize his experience to that degree? Thank you.

Speaker 2

Can you repeat the last sentence?

Speaker 0

Can you expand on how Protalix BioTherapeutics might utilize his experience in that avenue of, I guess, general interest in business development and mergers and acquisition?

Speaker 2

I would like to add, Gilad brings, I would say, deep experience or vast experience in multiple aspects and disciplines of financial and business, you know, activity and know-how and knowledge. Protalix BioTherapeutics 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 will 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 an 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.

Speaker 0

All right, thank you so much.

Speaker 2

This does not mean that Gilad or anyone else on the management does not have experience in business development, mergers and acquisitions, but let's leave these big words. We are not in a situation where we open, I hope we operate in a responsible and rational way. We are not going to risk the company. It will not happen.

Speaker 3

As a reminder, to ask a question, please press star one. The next question is from Dror Bashan, a private investor. Please go ahead.

Speaker 2

Yes, good morning, gentlemen. Eyal, thank you so much for your dedicated service over the past six years. We appreciate it. Can you please give me an idea of what the remaining value of our contract with Chiesi is, please?

Speaker 1

Other than the royalties, which 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 forfeited market share that they are sharing with us, we believe that Protalix BioTherapeutics can be entitled up to half a billion dollars in milestones, both commercial and regulatory. Again, it's far out. We're talking about, you know, by 2030, and it all depends on the market and their penetration. Those can be achievable numbers.

Speaker 2

Thank you.

Speaker 1

You're welcome, and thanks for the kind words.

Speaker 3

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

Speaker 2

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

Speaker 3

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