프로탈릭스 바이오테라퓨틱스(PLX) 2026년 2분기 실적 발표 콜: 엘파브리오가 매출 성장 견인

핵심 요약

• 프로탈릭스 바이오테라퓨틱스는 2026년 2분기 매출액이 1,990만 달러로, 주로 키에시 대상 매출 증가에 힘입어 2025년 2분기 1,570만 달러 대비 26.8% 증가했다고 발표했다.
• 2분기 순이익은 380만 달러(기본 및 희석 주당순이익 0.05달러)로, 전년 동기 16만 4,000달러(주당순이익 0.00달러)에서 증가했다.
• 상반기 매출액은 엘파브리오의 성과와 2026년 1분기에 인식된 키에시 마일스톤 2,500만 달러에 힘입어 전년 동기 2,580만 달러 대비 5,360만 달러에 달했다.
• 2026년 6월 30일 기준 현금, 현금성 자산 및 단기 은행 예금은 총 4,070만 달러였다. 프로탈릭스는 미상환 부채나 워런트가 없는 상태다.
• 경영진은 파트너사의 주문 및 출하 시점에 따라 분기별 변동성이 발생할 수 있다고 주의를 당부하면서도, 2026년 연간 매출 가이던스를 재확인했다.
• PRX-115의 RELEASE 임상 2상 연구는 순조롭게 진행되고 있다. 경영진은 2026년 말까지 환자 등록을 완료하고 2027년 하반기에 톱라인 결과를 발표할 것으로 예상한다.

주요 재무 데이터

2026년 상반기 매출액은 5,360만 달러로, 2025년 상반기의 2,580만 달러와 비교된다. 제품 판매 매출은 전년 동기 2,540만 달러 대비 2,720만 달러를 기록했다.

사업 및 영업 실적

엘파브리오는 프로탈릭스와 키에시의 파트너십을 통해 주요 상업적 성장 동력으로 자리를 지켰다. 경영진은 2분기 구매 실적에 기저 사업 성장과 키에시의 재고 관리가 모두 반영되었다고 밝혔다. 이에 따라 회사는 개별 분기보다 연간 실적을 살펴보는 것이 더 유용하다고 보고 있다.

경영진은 최근 유럽에서 엘파브리오의 4주 1회 투여 방식이 승인됨에 따라 상업적 입지가 강화되었다고 전했다. 회사는 2031년까지 전 세계 파브리병 시장이 약 32억 달러 규모로 성장할 것으로 전망하며, 엘파브리오가 이 시장의 15%~20%를 점유할 수 있을 것으로 본다고 밝혔다.

난치성 통풍 치료를 위한 프로탈릭스의 지속형 유리카제 후보물질 PRX-115는 RELEASE 임상 2상 다중 투여 연구에서 계속 순항하고 있다. 경영진은 계획된 임상 기관이 거의 모두 활성화되었으며, 단 1개 기관만 남아있을 가능성이 있다고 전했다.

경영진 가이던스

프로탈릭스는 2026년 연간 매출 가이던스를 유지했으나, 실적 발표 전화회의에서 구체적인 가이던스 범위를 제시하지는 않았다. 경영진은 긍정적인 매출 흐름과 엘파브리오의 지속적인 확장이 이러한 전망을 뒷받침한다고 설명했다.

회사는 차질 없는 진행을 전제로 RELEASE 연구의 환자 등록이 2026년 말까지 완료될 것으로 기대하며, 2027년 하반기에 톱라인 결과가 나올 것으로 예상한다.

RELEASE 임상 진행과 추가 전임상 및 임상 프로그램 진전에 따라 R&D 지출이 증가할 것으로 예상된다. 경영진은 또한 신규 R&D 법안에 따른 보조금 지원도 계속 유지될 것으로 기대하고 있다.

리스크 및 관전 포인트

• 파트너사의 주문 시점, 출하 일정 및 재고 관리에 따라 분기 간 매출이 변동될 수 있다.
• PRX-115 임상 3상 용법 선택은 유효성, 면역원성, 항약물 항체 및 주사 관련 반응을 포함한 임상 2상 결과 전체를 종합적으로 고려하여 결정될 예정이다.
• 경영진은 선호 용법이 메토트렉세이트 없이 4주 1회 투여하는 방식이 될지, 메토트렉세이트와 함께 8주 1회 투여하는 방식이 될지 판단하기에는 아직 이르다고 밝혔다.
• 목표로 하는 2026년 말 환자 등록 완료 일정은 연구 진행 상황에 따라 변동될 수 있다.
• 임상 활동 증가로 인해 향후 R&D 비용이 늘어날 것으로 예상된다.

애널리스트 Q&A 주요 내용

애널리스트들은 프로탈릭스가 PRX-115의 임상 3상 용법을 어떻게 결정할지에 주목했다. 경영진은 반응률이나 투여 빈도 외에도 다양한 요소를 반영할 것이라고 밝혔다. 면역원성, 항약물 항체, 주사 관련 반응, 그리고 메토트렉세이트 투여를 피할 수 있는지 여부도 결정에 영향을 미치게 된다.

36mg 고정 용량의 PRX-115에 대해 경영진은 임상 1상의 약동학 및 약력학 데이터를 기반으로 결정된 것이라고 설명했다. 진행 중인 다중 투여 임상 2상 연구를 통해 군별 항약물 항체 반응을 더욱 명확히 파악할 수 있을 것으로 예상된다.

엘파브리오 구매 패턴과 관련해 경영진은 2분기의 견조한 주문 수준이 부분적으로 각 시장 및 제조 요건에 맞춘 키에시의 재고 계획에 따른 것이라고 전했다. 아울러 분기별 주문을 단독으로 해석해서는 안 된다는 점을 재차 강조했다.

경영진은 또한 기존 난치성 통풍 시장 선도 제품의 매출액이 2025년 13억 달러에서 16억 달러 추세로 증가하고 있음을 지적하며, 이는 PRX-115에 고무적인 상황이라고 평가했다.

실적 발표 전화회의 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.

질의응답

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.