Protalix BioTherapeutics, Inc. (PLX) 2026 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics first-quarter 2026 financial and business results conference call. As a reminder, this conference is being recorded.

各位女士、先生，早安，歡迎參加 Protalix BioTherapeutics 2026 年第一季財務與業務成果電話會議。提醒各位，本次會議將被錄音。

I will now turn the conference over to our host, Mr. Mike Moyer of LifeSci Advisors, Investor Relations for Protalix. Thank you. Please go ahead.

現在我將把會議交給我們的主持人——LifeSci Advisors 的 Mike Moyer 先生，負責 Protalix 的投資人關係。謝謝。請開始。

Thank you, operator, and welcome to the Protalix BioTherapeutics Q1 2026 financial results and business update conference call. With me today are Dror Bashan, President and CEO of Protalix; and Gilad Mamlok, Senior Vice President and Chief Financial Officer.

謝謝接線員，歡迎參加 Protalix BioTherapeutics 2026 年第一季財務結果與業務更新電話會議。今天與我一同出席的有 Protalix 總裁暨執行長 Dror Bashan，以及資深副總裁兼財務長 Gilad Mamlok。

A press release announcing the financial results and corporate updates were issued this morning and are 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.

今早我們已發布新聞稿，公布財務結果與公司最新進展，目前可於 Protalix 官網查閱。請花點時間閱讀新聞稿中關於前瞻性陳述的免責聲明。財報新聞稿與本次電話會議均包含前瞻性陳述。這些前瞻性陳述受已知與未知風險及不確定性影響，可能導致實際結果與所述內容出現重大差異。可能導致實際結果不同的因素已在免責聲明以及 Protalix 向美國證券交易委員會提交的文件中說明。

I will now turn the call over to Mr. Bashan. Dror?

現在我將把電話交給 Bashan 先生。Dror？

Thank you, Mike, and thank you, everyone, for joining our Q1 2026 financial results and business update call. I want to begin by highlighting 2 points that underscore the strength of our business today. First, during the quarter, we received a $25 million milestone from Chiesi, following the European Commission approval of Elfabrio's every four weeks dosing regimen. As a result, we ended the first quarter of this year with $51 million in cash, providing us with a strong balance sheet and substantial financial flexibility and sufficient funds to support our ongoing operations as well as our Phase 2 RELEASE study with PRX-115.

謝謝你，Mike，也謝謝各位參加我們 2026 年第一季財務結果與業務更新電話會議。我想先強調兩點，以凸顯我們目前業務的強勁表現。第一，本季在歐盟執委會核准 Elfabrio 每四週一次的給藥方案後，我們自 Chiesi 收到 2,500 萬美元的里程碑款。因此，我們在今年第一季末的現金達 5,100 萬美元，提供我們強健的資產負債表、充足的財務彈性，以及足以支持持續營運與 PRX-115 的第二期 RELEASE 研究所需的資金。

Second, we are reaffirming our 2026 guidance. We continue to expect total revenue for the year to range from approximately $78 million to $83 million, inclusive of the $25 million milestones received from Chiesi. Within that outlook, we anticipate Elfabrio revenues, excluding milestones of approximately $33 million to $35 million and Elelyso revenues of approximately $20 million to $23 million. Taken together, this guidance reflects the strength of our commercial partnerships and our confidence in execution across our business for the year ahead.

第二，我們重申 2026 年財測指引。我們仍預期全年總營收約為 7,800 萬至 8,300 萬美元，包含自 Chiesi 收到的 2,500 萬美元里程碑款。在此展望中，我們預期 Elfabrio 營收（不含里程碑款）約為 3,300 萬至 3,500 萬美元，Elelyso 營收約為 2,000 萬至 2,300 萬美元。綜合而言，該指引反映我們商業合作夥伴關係的實力，以及我們對未來一年在各項業務執行力的信心。

We entered 2026 with a good momentum with the regulatory progress for Elfabrio in Europe, which triggered a $25 million milestone payment, the continued enrollment of our PRX-115 Phase 2 RELEASE study and a growing focus on our rare renal disease preclinical pipeline.

我們以良好動能進入 2026 年，包括 Elfabrio 在歐洲的法規進展（觸發 2,500 萬美元里程碑付款）、PRX-115 第二期 RELEASE 研究持續收案，以及我們對罕見腎臟疾病臨床前產品線日益增加的聚焦。

We remain confident in our strategy for the years ahead. Our partner, Chiesi, continues to execute well with Elfabrio across approved markets. Following the European Commission recent approval of every four weeks regimen, we believe Elfabrio is well positioned to meaningfully reduce treatment burden for eligible patients in the European Union without compromising efficacy. This added dosing flexibility strengthens Elfabrio's competitive position and supports broader adoption over time. In the United States, the FDA-approved dosing regimen remains unchanged.

我們對未來數年的策略仍具信心。我們的合作夥伴 Chiesi 持續在已核准市場中良好推進 Elfabrio。隨著歐盟執委會近期核准每四週一次的療程，我們相信 Elfabrio 能在不犧牲療效的前提下，為歐盟符合條件的患者顯著降低治療負擔。新增的給藥彈性強化了 Elfabrio 的競爭定位，並支持其隨時間推進更廣泛的採用。在美國，FDA 核准的給藥方案維持不變。

Looking longer term with the global Fabry market projected to approach approximately $3.2 billion by 2031, we believe Elfabrio has the potential to achieve a meaningful 15% to 20% market share globally, supported by its differentiated profile.

從更長期來看，全球法布瑞（Fabry）市場預計到 2031 年將接近約 32 億美元；我們相信在其差異化特性支持下，Elfabrio 有潛力在全球取得具意義的 15% 至 20% 市占率。

We believe our revenue mix, particularly the continued expansion of Elfabrio positions us well for substantial long-term value creation. On our clinical side, PRX-115 continues to move forward as planned. The Phase 2 RELEASE study is actively enrolling, and we remain encouraged by the program profile based on the Phase 1 data. We believe it has the potential to improve outcomes for patients with uncontrolled gout. We continue to expect top line results in the second half of 2027.

我們認為我們的營收組合，特別是 Elfabrio 的持續擴張，使我們具備創造可觀長期價值的良好定位。在臨床方面，PRX-115 依計畫持續推進。第二期 RELEASE 研究正積極收案，我們也基於第一期數據對該計畫的特性持續感到鼓舞。我們相信其有潛力改善未受控制痛風患者的治療結果。我們仍預期在 2027 年下半年取得主要（top line）結果。

Beyond 115, our strategy remains centered on rare renal diseases where we believe our capabilities and platform offer a clear advantage. In our view, our business model limits downside risk while preserving meaningful upside as we advance our clinical programs and continue our commercial partnership.

除 115 之外，我們的策略仍聚焦於罕見腎臟疾病領域，我們相信自身能力與平台在此具備明確優勢。依我們看法，我們的商業模式在推進臨床計畫並延續商業合作夥伴關係的同時，能限制下行風險並保留可觀的上行潛力。

With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook.

接下來我將把電話交給 Gilad，請他詳細說明我們的財務結果與展望。

Thank you, Dror. For the first quarter of 2026, total revenue was $33.8 million, driven mainly by the $25 million milestone payment received from Chiesi, following approval of the every four weeks dosing regimen for Elfabrio in Europe. This milestone underscores the value embedded in our commercial partnerships.

謝謝你，Dror。2026 年第一季總營收為 3,380 萬美元，主要由 Chiesi 支付的 2,500 萬美元里程碑款所帶動，該款項係因 Elfabrio 在歐洲獲核准每四週一次的給藥方案而取得。此里程碑凸顯我們商業合作夥伴關係中所蘊含的價值。

Revenues from selling goods were $7.4 million compared to $10 million in the first quarter of 2025. This change reflects lower Elelyso purchases by Pfizer and Fiocruz, mainly due to timing and inventory dynamics and was partially offset by sales to Chiesi.

商品銷售收入為 740 萬美元，較 2025 年第一季的 1,000 萬美元下降。此變動反映 Pfizer 與 Fiocruz 對 Elelyso 的採購量較低，主要由於時點與庫存動態所致，並部分被對 Chiesi 的銷售所抵銷。

As we have noted previously, quarterly product revenues can fluctuate based on partner purchasing patterns, and we encourage investors to focus on full year performance rather than quarter-to-quarter variability.

如我們先前所述，季度產品收入可能會因合作夥伴的採購模式而波動；我們建議投資人著重於全年表現，而非逐季的變動。

Cost of revenues was $4.1 million compared to $8.2 million for the same period in 2025. The decrease was mainly attributable to lower sales volumes to Pfizer and Fiocruz, partially offset by increased sales to Chiesi.

營收成本為 410 萬美元，較 2025 年同期的 820 萬美元下降。下降主要歸因於對 Pfizer 與 Fiocruz 的銷售量較低，部分被對 Chiesi 銷售增加所抵銷。

R&D expenses increased to $5.4 million, up from $3.5 million in the prior year period, driven mainly by preparations for and initiation of the PRX-115 Phase 2 RELEASE study. This increase reflects a deliberate allocation of capital towards advancing PRX-115, which remains our top clinical priority.

研發費用增加至 540 萬美元，高於前一年同期的 350 萬美元，主要由 PRX-115 第二期 RELEASE 研究的準備工作與啟動所帶動。此增加反映我們有意將資本配置於推進 PRX-115，該計畫仍是我們最優先的臨床重點。

SG&A expenses were $3.1 million, up $0.5 million, reflecting modest growth year-over-year, largely attributable to personnel-related costs. As a result of the milestone revenues and ongoing cost discipline, net income for the quarter was $18.3 million or $0.23 per share and $0.22 on a fully diluted basis compared to a net loss of $3.6 million or $0.05 per share in the prior year period.

銷售、一般及行政（SG&A）費用為 310 萬美元，增加 50 萬美元，反映年增幅度溫和，主要歸因於人員相關成本。受惠於里程碑收入與持續的成本紀律，本季淨利為 1,830 萬美元，或每股 0.23 美元；以完全稀釋基礎計為每股 0.22 美元；相較之下，前一年同期為淨損 360 萬美元，或每股虧損 0.05 美元。

Importantly, the company continues to operate a profitable commercial business and milestone provides additional upside without changing our underlying expense base.

重要的是，公司持續經營一項獲利的商業業務，而該里程碑在不改變我們基本費用結構的情況下，提供了額外的上行空間。

Turning to the balance sheet. Cash, cash equivalents and short-term bank deposits totaled $51 million as of March 31, 2026. We have no outstanding debt or warrants, providing us with substantial financial flexibility to support our continued pipeline advancement. In summary, we remain in a strong financial position and well capitalized to advance our key programs to the next set of clinical and commercial milestones.

接著談資產負債表。截至2026年3月31日，現金、約當現金及短期銀行存款合計為5,100萬美元。我們沒有任何未償債務或認股權證，這為我們提供了充足的財務彈性，以支持我們持續推進研發管線。總結而言，我們仍維持強勁的財務狀況，資本充裕，可推進我們的關鍵專案邁向下一階段的臨床與商業里程碑。

With that, I will turn the call back over to Dror. Dror?

接下來，我把電話交回給Dror。Dror？

Thank you, Gilad. To conclude, as we look ahead, we do so from a position of strength. With the $25 million milestone triggered by the EC approval, we hold approximately $51 million in cash as of March 31 of this year, giving us the financial flexibility to continue investing in programs and partnerships that will drive our next stage of growth.

謝謝你，Gilad。最後總結，展望未來，我們是以強勢的姿態前進。隨著EC核准所觸發的2,500萬美元里程碑款，截至今年3月31日我們持有約5,100萬美元現金，讓我們具備財務彈性，得以持續投資於將推動下一階段成長的專案與合作夥伴關係。

We are reaffirming our 2026 guidance and our expectation that Elfabrio can achieve 15% to 20% market share of the Fabry market by 2031. This reflects our confidence in the product, our partnership with Chiesi and the continued expansion of Elfabrio global.

我們重申2026年財測指引，並維持我們對Elfabrio在2031年前可達成法布瑞（Fabry）市場15%至20%市占率的預期。這反映了我們對產品、與Chiesi的合作夥伴關係，以及Elfabrio全球持續擴張的信心。

Now I will turn -- I would like to ask the operator to open the call for questions.

現在我將把電話交出——我想請接線員開放提問。

(Operator Instructions)

（接線員指示）

Ram Selvaraju, H.C. Wainwright.

Ram Selvaraju，H.C. Wainwright。

Congratulations on a good quarter. I wanted to ask if you could comment on the core determinants of the cadence with which you expect to receive revenue from Chiesi regarding Elfabrio sales? And if -- what you think the likelihood is, if any, of increases to the full year 2026 guidance for Elfabrio-related royalty-based revenue?

恭喜本季表現不錯。我想請問，您是否可以評論一下，您預期從Chiesi就Elfabrio銷售所取得收入的節奏，其核心決定因素是什麼？以及——您認為是否有可能、若有的話，2026全年與Elfabrio相關、以權利金為基礎的收入指引會上調的可能性有多大？

So I think as we mentioned last time, we just -- Chiesi, we received the approval for every four weeks on March 5. And Chiesi is now in the process of going country-by-country and getting the local reimbursement approval. So I think we are going to see the effect mostly in the second half of the year, and we expect the second half of the year to be much stronger with regards to Chiesi sales. At that point of time, we still stick to the same guidance we provided.

我想如同我們上次提到的，我們——Chiesi在3月5日取得了每四週一次給藥的核准。Chiesi目前正逐國推進並取得各地的本地給付核准。因此我認為其影響主要會在今年下半年顯現，我們預期下半年在Chiesi銷售方面會強勁得多。在此時點，我們仍維持先前提供的相同指引。

And secondly, can you provide any commentary on how enrollment is going in the RELEASE trial? And if you can potentially provide us with the timing for completion of enrollment?

第二個問題，您能否就RELEASE試驗的收案情況提供一些評論？以及是否可以提供完成收案的時間點？

As we said before, we are not updating regarding the continuing progress of the enrollment. It does progress. As we mentioned, we have many sites open. Our target is to finish enrollment by the end of 2026 and have the top-line results in the second half of 2027.

如同我們先前所說，我們不會就收案持續進展提供更新。收案確實在推進。我們也提到，我們已開設許多試驗中心。我們的目標是在2026年底前完成收案，並在2027年下半年取得主要（top-line）結果。

And then lastly, with respect to the positioning of 115 in the overall gout market, do you expect this to change meaningfully with the advent of next-generation URAT1 inhibitors? Or do you anticipate that the treatment refractory -- the refractory gout market -- segment is more or less likely to remain the same?

最後，關於115在整體痛風市場中的定位，隨著下一代URAT1抑制劑的出現，您預期這個定位會有顯著改變嗎？或者您預期治療難治——難治性痛風市場——這個分群大致上會維持不變？

So Ram, this is Dror. Thank you. We believe that, I would say, this segment of uncontrolled gout patients will stay and there will be, I would say, enough room and growing even for patients qualified for Uricase.

Ram，我是Dror。謝謝。我們相信，我會說，這一群控制不佳的痛風患者將會持續存在，而且我會說，即使是符合使用尿酸酶（Uricase）資格的患者，也會有足夠的空間，甚至還會成長。

John Vandermosten, Zacks.

John Vandermosten，Zacks。

I know you mentioned that it's only the very first initial stages of the launch of Elfabrio for every four weeks. But do you have any initial data or initial insight into the uptake in the market on that approach?

我知道你提到Elfabrio每四週一次給藥的上市才剛開始、仍在非常初期的階段。但你們是否有任何初步數據或初步洞見，關於市場對這種方式的採用情況？

It's too early for that, John. But we do see -- I mean, when we talk with Chiesi, I mean, they're optimistic about the progress and they expect to see the progress. But again, in terms of seeing the actual results, I don't think we're going to see them before the second half of the year.

John，現在談這個還太早。不過我們確實看到——我的意思是，當我們與Chiesi溝通時，他們對進展感到樂觀，也預期會看到進一步的進展。但再次強調，就實際結果而言，我不認為在今年下半年之前會看到。

Understood. And there was a mention in the press release about Chiesi continuing launches and regulatory efforts around the globe. And can you give us an update on how things are going in that respect? Any new geographies and any geographies that we should expect in the next few months or next quarters in terms of expanding exposure of patients to Elfabrio?

了解。另外，新聞稿中提到Chiesi在全球持續推進上市與法規工作。你能否就這方面提供最新進度？是否有新的地理市場？以及未來幾個月或接下來幾季，是否有我們應該期待的地區，能讓更多患者接觸到Elfabrio、擴大覆蓋？

So there are a few targets from here in the next 12 months, I would say. Some are more significant, some are less, but we are going to report them immediately once there's approval. But it's a continuous route of getting more approvals, and we see what they have in the pipeline, and we will update as soon as they receive the approval.

我會說，接下來12個月有幾個目標。有些更重要，有些相對沒那麼重要，但一旦獲得核准我們就會立即對外公告。這是一條持續取得更多核准的路徑；我們也看到他們管線中的規劃，我們會在他們取得核准後盡快更新。

And then there's also a mention of PRX-119. And I was wondering what's the next milestone for PRX-119? And I'm thinking also in terms of like getting into the clinic or IND submission or something like that. How does that look, that program?

另外也提到了PRX-119。我想請問PRX-119的下一個里程碑是什麼？我也在想，例如進入臨床、或提交IND之類的。這個專案目前看起來如何？

We are developing and putting together different activities, if I may say, to make sure that we have -- we are on the right path, if I may say. We will update soon. I believe I hope by the end of this quarter, what we -- I mean, to which specific indication this mechanism of action works. And then we will, of course, detail when we expect to start Phase 1.

我們正在開發並整合不同的工作項目，如果我可以這麼說，以確保我們——如果我可以這麼說——走在正確的道路上。我們很快會更新。我相信、我希望在本季末之前，能說明我們——也就是這個作用機轉適用於哪一個特定適應症。接著我們當然也會詳細說明我們預期何時啟動第一期（Phase 1）。

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

目前沒有其他問題。我想把時間交回給Dror Bashan做結語。

So thank you, everybody, for joining us today, and we are looking forward to talk to you next quarter. Thank you.

謝謝各位今天加入我們，我們期待在下個季度再與各位交流。謝謝。

Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.

謝謝。今天的電話會議到此結束。您現在可以掛線，感謝您的參與。