Thank you, operator, and welcome to the Protalix BioTherapeutics Q2 2026 financial results and business update conference call. With me today are Dror Bashan, President and CEO, and Gilad Mamlok, Senior Vice President and Chief Financial Officer.

The press release announcing the financial results and corporate updates was issued this morning and is available now 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 US Securities and Exchange Commission. I will now turn the call over to Mr.

Bashan. Dror?

Thank you, Mike. Thank you, everyone, for joining this morning.

Our results today reflect the strength of our profitable commercial partnerships, and we remain confident in our outlook for this year. We enter the second half of 2026 with Elfabrio sales through Chiesi continuing to drive growth of our business.

Gilad will walk through the financial details, but the key driver in the first half was continued growth in Elfabrio's revenues together with the previously reported $25 million Chiesi milestone payment recognized in the first quarter of this year. Elfabrio sales through Chiesi continue to drive revenues from selling goods, and this performance reflects further global penetration of Elfabrio and continued growth.

This continued growth keeps us on track with our full-year 2026 revenue guidance. With the global Fabry market projected to reach approximately $3.2 billion by 2031, Elfabrio is positioned to capture 15% to 20% of this market, supported by our partnership with Chiesi, which is strengthened by the recent approval of the once-every-four-weeks dosing regimen in Europe.

We believe our revenue mix, particularly the continued expansion of Elfabrio, position us well for sustained long-term value creation and profitability. On the clinical side, PRX-115 continued to advance as planned.

PRX-115 is designed as a long-acting, differentiated uricase, and we believe it has the potential to meaningfully improve quality of life for patients with uncontrolled gout, which could be a significant inflection point and value driver for Protalix. There is a significant unmet need in this population, and we expect top-line results from our Release study in the second half of 2027.

Beyond PRX-115, our strategy remains centered on rare renal diseases where we believe our capabilities and platform offer a clear advantage, and we remain focused on execution across our partnerships and pipeline, and we believe our business model limits downside risks while preserving meaningful upside as we advance our clinical programs. With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook.

Gilad, please.

Thank you, Dror. For the second quarter of 2026, total revenues were $19.9 million compared to $15.7 million in the second quarter of 2025.

For the first half of 2026, total revenues were $53.6 million compared to $25.8 million for the first half of 2025. For the second quarter of 2026, revenues from selling goods were $19.8 million compared to $15.4 million in the second quarter of 2025, an increase of $4.4 million.

For the first half of 2026, revenues from selling goods were $27.2 million compared to $25.4 million for the first half of 2025, an increase of $1.8 million. The increase was driven mainly by higher sales of Elfabrio to Chiesi.

For the remainder of the results, I will report only on the second quarter, and you can refer to this morning's press release for additional year-to-date data. Cost of revenues was $7.8 million compared to $5.9 million in the same period in 2025, an increase of $1.9 million.

The increase was mainly attributable to higher sales volumes to Chiesi in finished goods, partially offset by lower sales to Pfizer. R&D expenses were $4.4 million, down from $6.0 million in the prior-year period, a decrease of $1.6 million.

The decrease was mainly driven by a $2.1 million grant recorded under the new R&D law as a reduction of R&D expenses. As of 2026, this grant is available for us under the R&D law on an ongoing basis.

We expect to continue to incur expenses as the Release study progresses and additional preclinical and clinical programs advance. SG&A expenses were $3.1 million, up $0.5 million from the prior-year period, largely attributable to higher salary and related expenses.

Financial income, net, was $0.2 million compared to financial expenses, net, of $0.5 million in the second quarter of 2025. The change was mainly due to exchange rate fluctuations.

Taxes on income were $1.1 million compared to $0.5 million in the second quarter of 2025, an increase of $0.6 million. This increase resulted mainly from taxes on income derived from Global Intangible Low-Taxed Income, or GILTI, resulting from limitations under IRC Section 174.

Net income for the quarter was $3.8 million, or $0.05 per share, basic and diluted, compared to net income of $164,000, or $0.00 per share, basic and diluted, in the second quarter of 2025. Turning to the balance sheet, cash, cash equivalents, and short-term bank deposits totaled $40.7 million as of June 30, 2026.

We have no outstanding debt or warrants, providing us with substantial financial flexibility to support our continued pipeline advancement. As we have noted in prior quarters, our revenues can vary from quarter to quarter based on the timing of shipments and orders from our partners.

We believe it is more useful to evaluate our business on a full-year basis, and we remain confident in our full-year 2026 guidance. With that, I will turn the call back over to Dror.

Thank you, Gilad. In closing, positive revenue trends keep us firmly on track to meet our full-year 2026 guidance.

We have a strong cash position to maintain our operations and advance our clinical and preclinical assets. We are confident in the momentum behind our business and about the opportunities ahead.

Now I will ask the operator to open the line for questions.

Hi, this is Yan Z sitting in for Ram Selvaraju. Thanks for taking my questions.

I have two. The first is, your presentation highlights E4W without methotrexate and the E8W with MTX as the two differentiated profiles within RELEASE.

What totality of evidence framework will determine which regimen advances to Phase 3, and could a modest month-six responder rate difference be outweighed by eliminating MTX or extending dosing to E8W?

Can you repeat the question? Actually both.

As you see, one of the five arms is without methotrexate, which can be a huge competitive edge, but also a lower frequency of using the drug, it's also a big advantage, and we potentially can have both.

Right. I'll repeat the question.

My question is what totality of evidence will determine which regimen advances to Phase 3? Could a modest month-six responder rate difference be outweighed by eliminating the methotrexate or extending dosing to every eight weeks?

We are running now the multiple dose study the Phase 2. We will have to see the outcome and by the outcome, we can decide with which regimen we continue.

It's difficult to tell you today. Under what we have from the mechanism of action and the data from the Phase 1 and whatever we understand about the molecule and the pegylation of the molecule and the outcomes we have so far, we think that these four arms of I'm not speaking about the placebo could be met.

Which one will be met better, we have to consider there is an immunogenicity aspect, there is the IRR aspect, it's not just the frequencies. Let's say, under the assumption immunogenicity is good or low or whatever the definition is, and with a pretty low IRR, and then it's only about the frequency and/or with or without methotrexate.

We have to see.

Got it, understood. The other question I have is relating to the 10-K, which reports approximately about 50% of Phase 1 subjects who have developed ADAs, and that comes with lower incidence at higher doses.

My question is how did the combined PK/PD and immunogenicity data support selecting that fixed 36 mg dose? What ADA profile in RELEASE would support every-four-week dosing without methotrexate?

In Phase 2, we will have I would say the ADA against the PEG, against the enzyme, we'll have I think a clearer picture of the different ADAs and how and what are the outcomes, of course, per the different arms. Then we will see where we are.

Don't forget, the Phase 2 is the multiple dose. Phase 1 was a single ascending dose.

We chose the 36 mg according to, one, I would say the PK/PD, if I may say, of course, and also under the assumption that this specific, I would say, regiment could beat the highest or the more, I would say, convenient and, by the way, for the patients, if I may say, both the once in four weeks without methotrexate and the once in eight weeks with methotrexate, which let's call them the highest outcomes, if possible.

Got it. Thank you so much for taking my questions.

Of course. Thank you.

Great. Nice to hear from you guys, Dror, Gilad, and congratulations on Elfabrio's patent term extension and the approval in South Korea.

Things are going pretty good for that product. Want to start out with a question on just the trend in purchases of Elfabrio.

I'm wondering, is there any benefit to having lumpy purchases, because we had a nice increase this quarter? I'm wondering, is that due perhaps to the new approvals in certain geographies or is there some other reason in terms of product runs or some other reason why it makes sense to have lumpy rather than steady purchases of Elfabrio?

John, good morning, and thank you. As we always say, in one quarter, we prefer to look at the picture always year-to-date.

We did have a nice quarter from Chiesi, which reflects also their growth of the business, but mainly reflects their inventory management.

There's no rationale behind why they wouldn't make it smooth rather than lumpy?

John, this is not a fair definition, I would say. They operate with a lot of sense and logic, of course, and they are responsible for what they are doing.

They see the demand, they know how much they sit on certain amount of inventories globally or per continent, and of course, they have manufacturing plan vis-à-vis other programs that are marketing. It's a big company.

All in all, this is how it was decided and applied. Of course, to make sure we sit on enough stocks, both DS and DP.

Okay. Jumping to 115, I believe you've opened up some new sites, or at least on clinicaltrials.gov, it seems like there are a number of sites listed there compared to previous or earlier in the year.

How is that going in terms of site activation and kind of where are you right now? How much can you tell me?

Then, how many more do you think might be opening in the future so far in 2026?

We have actually maybe one site is missing, that's it. At present, we expect to finalize enrollment within the next five months, by year-end, as we planned.

We'll have to see if things indeed will go this way. Far, good, knock on wood.

That's it. Nothing are fine.

It's I think overall, except one site that maybe is missing, we are actually signed on whatever we planned to, of course. A

last question is on kind of a bigger picture question on Amgen. They raised price pretty significantly this year.

First quarter and second quarter saw 20-plus percent price increases on Krystexxa. I'm wondering, what does that tell you about the market?

Does it make it look more attractive? I'm not sure of the details, perhaps it was a payer mix or something like that.

I didn't get into that, but I'm just wondering if you had any thoughts on what that dramatic price increase means for the space.

I don't have any insights on that. You get it from what they say, or you get it from calculating sales to estimated number of patients, or Oh,

it was in their press release, their second quarter press release. They said 23% increase in pricing even though volumes were down.

I didn't go into it, but my thought was the market will accept a higher price, which may make it look more attractive for you guys for 115. Just wanted to see if that had any impact on your thoughts for this product and the pathway forward.

The revenues keep growing. It was $1.3 billion in 2025.

We see now the trend going to $1.6 billion, it's very encouraging for 115 as well, as you said.

Exactly. Okay.

Great. I appreciate you guys' time and thanks for taking my questions.

Thank you.

Thank you. I just ask to thank everybody that joined our call.

We look forward to report on our Q3 results as well. I think overall, we have a good, strong cash position to maintain our operations and advance our clinical and preclinical assets.

Again, we are confident in the momentum behind our business and about the opportunities ahead. Thank you very much.