普羅塔利斯生物製藥 (PLX) 2026年第二季度業績電話會議：Elfabrio驅動營收增長

核心要點

• Protalix BioTherapeutics公佈2026財年第二季度營收為1990萬美元，同比增長26.8%（2025財年第二季度為1570萬美元），主要反映了對Chiesi銷售額的增加。
• 第二季度淨利潤從上年同期的16.4萬美元（每股收益0.00美元）增至380萬美元，基本和攤薄后每股收益均為0.05美元。
• 在前半年Elfabrio的增長以及2026財年第一季度確認的來自Chiesi的2500萬美元里程碑付款的支撐下，上半年營收達到5360萬美元，而上年同期為2580萬美元。
• 截至2026年6月30日，現金、現金等價物及短期銀行存款總計4070萬美元。Protalix沒有未償還債務或認股權證。
• 管理層重申了2026財年全年營收指引，同時提醒稱，合作伙伴的訂單和發貨時機可能會導致季度波動。
• PRX-115的RELEASE 2期研究仍在按計劃推進。管理層預計入組工作將在2026年底前完成，頂線數據將於2027年下半年公佈。

關鍵財務數據

2026財年上半年營收為5360萬美元，而2025財年上半年為2580萬美元。產品銷售收入總計為2720萬美元，而上年同期為2540萬美元。

業務與運營表現

通過Protalix與Chiesi的合作，Elfabrio仍是商業化的主要增長驅動力。管理層表示，第二季度的採購額既反映了基礎業務的增長，也反映了Chiesi的庫存管理。因此，公司認為全年的業績表現比單季度更有參考價值。

管理層表示，Elfabrio近期在歐洲獲得每四周給藥一次的批准，強化了其商業定位。公司引用數據預測，到2031年全球法佈雷病市場規模將達到約32億美元，並表示相信Elfabrio有望佔據該市場15%至20%的份額。

PRX-115是Protalix用於治療難治性痛風的長效尿酸酶候選藥物，目前正在推進RELEASE 2期多劑量研究。管理層指出，幾乎所有計劃中的臨牀試驗中心均已啟動，可能僅剩一箇中心尚未啟動。

管理層指引

Protalix維持了2026財年全年營收指引，儘管業績電話會議上未明確説明具體的指引區間。管理層表示，積極的營收趨勢和Elfabrio的持續擴張為這一前景提供了支撐。

公司預計，取決於執行情況，RELEASE研究的患者入組工作將於2026年底完成，並預計在2027年下半年獲得頂線結果。

隨着RELEASE研究的推進以及其他前臨牀和臨牀項目的展開，預計研發支出將有所增加。管理層還預計，根據新研發法案可獲得的補貼將持續有效。

風險與關注點

• 由於合作伙伴的訂單時機、發貨計劃及庫存管理，各季度之間的營收可能會出現波動。
• PRX-115 3期給藥方案的選擇將取決於2期研究的總體結果，包括療效、免疫原性、抗藥抗體以及輸液相關反應。
• 管理層表示，現在確定優選方案是傾向於無甲氨蝶呤的每四周給藥一次，還是結合甲氨蝶呤的每八周給藥一次，還為時過早。
• 預定於2026年底前完成入組的目標仍取決於研究的執行情況。
• 隨着時間推移，臨牀活動的增加預計將導致研發費用上升。

分析師問答精選

分析師關注的焦點是Protalix將如何為3期研究選擇PRX-115給藥方案。管理層表示，決策考慮的不僅僅是應答率或給藥頻率，免疫原性、抗藥抗體、輸液相關反應以及能否避免使用甲氨蝶呤也將影響選擇。

關於36毫克固定劑量的PRX-115，管理層表示這是根據1期藥代動力學和藥效學數據選定的。目前正在進行的2期多劑量研究預計將更清晰地展現不同治療組之間的抗藥抗體反應。

關於Elfabrio的採購模式，管理層將第二季度強勁的訂單水平部分歸因於Chiesi在各個市場的庫存規劃和生產需求。管理層重申，不應孤立看待季度訂單。

管理層還指出，現有難治性痛風市場領頭羊在2025年的營收為13億美元，並呈現趨向16億美元的勢頭，管理層稱這對PRX-115而言令人鼓舞。

業績電話會議完整文字記錄

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完整財報電話會議逐字稿

管理層陳述

Operator

Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics Second Quarter 2026 Financial and Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to your host, Mr. Mike Moyer of LifeSci Advisors, Investor Relations for Protalix. Please go ahead.

Mike Moyer

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

Dror Bashan

Thank you, Mike, and 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 entered 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, 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 4 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 continues 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 revenue 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.

Gilad Mamlok

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 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. Cost of revenues were $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 [indiscernible] and partially offset by lower sales to Pfizer. R&D expenses were $4.4 million, down from $6 million in the prior year period, a decrease of $1.6 million. The decrease was mainly driven by a $2.1 million 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. G&A expenses were $3.1 million, up $0.5 million from the prior year period, largely attributable to higher salary and related expenses. Finance 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 tax 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 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 advancements. 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.

Dror Bashan

Thank you, Gilad. In closing, positive revenue trends keeps 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.

Operator

[Operator Instructions] And our first question -- our first question will come from Raghuram Selvaraju with H.C. Wainwright.

分析師問答

Unknown Analyst

This is [ Yuan Zhi ] sitting in for Ram Selvaraju. I have 2. The first is, so your presentation highlights E4W without methotrexate and the E8W with MTX as the 2 differentiated profiles within RELEASE. What totality of evidence framework will determine which regimen advances to Phase 3? And could a modest month 6 responder rate difference be outweighed by eliminating MTX or extending dosing to E8W?

Dror Bashan

I repeat the question? Actually, both. I mean if you manage to 1 of the 5 [indiscernible] without methotrexate [indiscernible], which can be a huge competitive edge, but also a lower frequency of using the drug is also a big advantage, and we potentially can have both.

Unknown Analyst

Right. Okay. So yes, I'll repeat the question. It's -- my question is what totality of evidence will determine which regimen advances to Phase 3? And could a modest month 6 responder rate difference be outweighed by eliminating the methotrexate or extending dosing to every 8 weeks?

Dror Bashan

We are running now the multiple dose study on the Phase 2. We have to see the outcome. And by the outcome, we can decide with which regimens we continue. It's difficult to tell you today. I mean, 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 4 arms, 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 an IRR aspect. So it's not just the frequency. But 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.

Unknown Analyst

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 does the combined PK, PD and immunogenicity data support selecting that fixed 36-milligram dose? And what ADA profile and RELEASE would support every 4 weeks dosing without methotrexate?

Dror Bashan

So we will -- in Phase 2, we will have the, I would say, the ADA against the enzyme. So we have, I think, a clearer picture of the different ADAs and how -- and what are the outcomes, of course, the different arms. So then we'll see where we are. Don't forget the Phase 2 is the multiple dose. Phase 1 was a single ascending dose chose 36-milligram 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, regimen could be the highest or the more, I would say, convenient and by the way, for the patients, if I may say, both once in 4 weeks without methotrexate and the once in 8 weeks with methotrexate, which call them like the highest outcomes if possible.

Operator

Our next question will come from John Vandermosten with Zacks SCR.

John Vandermosten

Great. Nice to hear from you guys. And congratulations on Elfabrio's patent term extension and the approval in South Korea. Things are going pretty good for that product. I 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. And I'm wondering, is that due perhaps to the new approvals in certain geographies? Or is there some other reason in terms of like product runs or some other reason why it makes sense to have lumpy rather than steady purchases of Elfabrio?

Gilad Mamlok

John, thank you. As we always say, 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.

John Vandermosten

Okay. So there's no -- I mean, there's no rationale behind why they wouldn't make it smooth rather than lumpy.

Dror Bashan

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 have their own -- they see the demand. They know how much they sit on certain amount of inventories globally or continent. And of course, their manufacturing plant vis-a-vis other programs that are marketing with a big company. So all in all, this is how it was decided and applied. And of course, to make sure we sit on enough stocks, both [ DS and DP ].

John Vandermosten

Okay. And 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 -- early 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? And then how many more do you think might be opening in the future so far in 2026?

Dror Bashan

We have actually maybe one site is missing. That's it. And we -- at present, we expect to finalize enrollment within the next 5 months, I mean by year-end as we planned. We'll have to see if things indeed will go this way. So far, so good, knock on wood. That's it. I think overall, except one site that maybe is missing, we are actually signed on whatever we plan to course.

John Vandermosten

And 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. And 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 have any thoughts on what that dramatic price increase means for the space.

Dror Bashan

I don't have any insights on that. And I don't know, you get it from what they say or you get it from calculating sales to estimate the number of patients or...

John Vandermosten

It was in the press release or second quarter press release, they said 23% increase in and pricing, even the volumes were down. And they didn't go into it, but I mean, my thought was there's -- the market will accept a higher price, which may make it look more attractive for you guys for 115. So I just wanted to see if that had any impact on your thoughts for this product and the pathway forward.

Gilad Mamlok

The revenues keep growing. It was $1.3 billion in 2025. We see now the trend going to $1.6 billion. So it's very encouraging for 115 as well, as we said.

Operator

And this now concludes our question-and-answer session. I would like to turn the floor back over to Dror Bashan for closing comments.

Dror Bashan

Thank you. So I just like to thank everybody that joined our call, and 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. And again, we are confident in the momentum behind our business and about the opportunities ahead. So thank you very much.

Operator

Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines, and have a wonderful day.