普罗塔利斯生物制药 (PLX) 2026年第二季度业绩电话会议：Elfabrio驱动营收增长

核心要点

• Protalix BioTherapeutics公布2026财年第二季度营收为1990万美元，同比增长26.8%（2025财年第二季度为1570万美元），主要反映了对Chiesi销售额的增加。
• 第二季度净利润从上年同期的16.4万美元（每股收益0.00美元）增至380万美元，基本和摊薄后每股收益均为0.05美元。
• 在前半年Elfabrio的增长以及2026财年第一季度确认的来自Chiesi的2500万美元里程碑付款的支撑下，上半年营收达到5360万美元，而上年同期为2580万美元。
• 截至2026年6月30日，现金、现金等价物及短期银行存款总计4070万美元。Protalix没有未偿还债务或认股权证。
• 管理层重申了2026财年全年营收指引，同时提醒称，合作伙伴的订单和发货时机可能会导致季度波动。
• PRX-115的RELEASE 2期研究仍在按计划推进。管理层预计入组工作将在2026年底前完成，顶线数据将于2027年下半年公布。

关键财务数据

2026财年上半年营收为5360万美元，而2025财年上半年为2580万美元。产品销售收入总计为2720万美元，而上年同期为2540万美元。

业务与运营表现

通过Protalix与Chiesi的合作，Elfabrio仍是商业化的主要增长驱动力。管理层表示，第二季度的采购额既反映了基础业务的增长，也反映了Chiesi的库存管理。因此，公司认为全年的业绩表现比单季度更有参考价值。

管理层表示，Elfabrio近期在欧洲获得每四周给药一次的批准，强化了其商业定位。公司引用数据预测，到2031年全球法布雷病市场规模将达到约32亿美元，并表示相信Elfabrio有望占据该市场15%至20%的份额。

PRX-115是Protalix用于治疗难治性痛风的长效尿酸酶候选药物，目前正在推进RELEASE 2期多剂量研究。管理层指出，几乎所有计划中的临床试验中心均已启动，可能仅剩一个中心尚未启动。

管理层指引

Protalix维持了2026财年全年营收指引，尽管业绩电话会议上未明确说明具体的指引区间。管理层表示，积极的营收趋势和Elfabrio的持续扩张为这一前景提供了支撑。

公司预计，取决于执行情况，RELEASE研究的患者入组工作将于2026年底完成，并预计在2027年下半年获得顶线结果。

随着RELEASE研究的推进以及其他前临床和临床项目的展开，预计研发支出将有所增加。管理层还预计，根据新研发法案可获得的补贴将持续有效。

风险与关注点

• 由于合作伙伴的订单时机、发货计划及库存管理，各季度之间的营收可能会出现波动。
• PRX-115 3期给药方案的选择将取决于2期研究的总体结果，包括疗效、免疫原性、抗药抗体以及输液相关反应。
• 管理层表示，现在确定优选方案是倾向于无甲氨蝶呤的每四周给药一次，还是结合甲氨蝶呤的每八周给药一次，还为时过早。
• 预定于2026年底前完成入组的目标仍取决于研究的执行情况。
• 随着时间推移，临床活动的增加预计将导致研发费用上升。

分析师问答精选

分析师关注的焦点是Protalix将如何为3期研究选择PRX-115给药方案。管理层表示，决策考虑的不仅仅是应答率或给药频率，免疫原性、抗药抗体、输液相关反应以及能否避免使用甲氨蝶呤也将影响选择。

关于36毫克固定剂量的PRX-115，管理层表示这是根据1期药代动力学和药效学数据选定的。目前正在进行的2期多剂量研究预计将更清晰地展现不同治疗组之间的抗药抗体反应。

关于Elfabrio的采购模式，管理层将第二季度强劲的订单水平部分归因于Chiesi在各个市场的库存规划和生产需求。管理层重申，不应孤立看待季度订单。

管理层还指出，现有难治性痛风市场领头羊在2025年的营收为13亿美元，并呈现趋向16亿美元的势头，管理层称这对PRX-115而言令人鼓舞。

业绩电话会议完整文字记录

完整财报电话会议逐字稿

管理层陈述

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.

分析师问答

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.