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ZLAB

Zai LabF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-06-03
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2026-05-09
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Earnings documents stored for ZLAB.

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Investor releaseQuarter not tagged2026-05-09

Zai Lab Q1 Earnings Call Highlights

MarketBeat

Interested in Zai Lab Limited Unsponsored ADR? Here are five stocks we like better. Q1 product revenue fell 6% year over year to $99.6 million, as ZEJULA weakness and other portfolio dynamics pressured results. Zai Lab also posted a wider operating loss of $69.4 million and said it expects near-term revenue pressure in 2026 before returning to growth in 2027. Management highlighted a series of pipeline and regulatory milestones, led by oncology asset zoci, which showed encouraging intracranial response data in small cell lung cancer and could support accelerated approval timing. The company is also advancing immunology candidate ZL-1503 and noted positive partner data for povetacicept. The commercial portfolio was mixed: VYVGART saw double-digit volume growth, XACDURO faced supply constraints, and KarXT is set to launch in China for schizophrenia in Q2. Zai Lab ended the quarter with $761.3 million in cash and said it remains focused on execution and capital discipline. Zai Lab Stock Has Fallen to Value Levels Zai Lab (NASDAQ:ZLAB) reported a year-over-year decline in first-quarter 2026 product revenue as pressure on ZEJULA weighed on results, while management emphasized progress across its global oncology and immunology pipeline and pointed to multiple upcoming regulatory and clinical milestones. On the company’s earnings call, Founder, Chairperson and CEO Samantha Du said Zai Lab is at “a pivotal moment,” citing the company’s investment in a fully integrated research and development platform and its move toward global registrational studies. Du said the company expects to submit its first global biologics license application to the U.S. Food and Drug Administration in late 2027, tied to its lead asset zoci. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% “Our pipeline is expanding, our global assets are generating meaningful data, and our lead asset is in global pivotal stage,” Du said. She added that Zai Lab is using artificial intelligence and data-driven approaches across the organization to improve speed, precision and efficiency. Chief Financial Officer Yajing Chen said total product revenue in the first quarter declined 6% year over year to $99.6 million. She said the decline was driven by lower ZEJULA sales, partially offset by continued growth from ZEJULA and NUZYRA, as stated on the call. → Light Speed Returns: Corning Cashes In...

Investor releaseQuarter not tagged2026-05-07

Zai Lab Limited (ZLAB) Reports Q1 Earnings: What Key Metrics Have to Say

Zacks

For the quarter ended March 2026, Zai Lab Limited Unsponsored ADR (ZLAB) reported revenue of $99.61 million, down 6.5% over the same period last year. EPS came in at -$0.46, compared to -$0.45 in the year-ago quarter. The reported revenue represents a surprise of -8.21% over the Zacks Consensus Estimate of $108.52 million. With the consensus EPS estimate being -$0.58, the EPS surprise was +20.69%. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how Zai Lab Limited performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Product Revenue, net: $95.56 million compared to the $107.93 million average estimate based on three analysts. Product Revenue- NUZYRA: $16.3 million versus the two-analyst average estimate of $16.46 million. The reported number represents a year-over-year change of +7.8%. Collaboration revenue: $4.06 million versus the two-analyst average estimate of $0.87 million. Product Revenue- XACDURO: $8.6 million versus the two-analyst average estimate of $7.84 million. Product Revenue- ZEJULA: $30 million versus the two-analyst average estimate of $41.33 million. The reported number represents a year-over-year change of -39.4%. Product Revenue- VYVGART: $17.6 million compared to the $20.95 million average estimate based on two analysts. The reported number represents a change of -2.8% year over year. View all Key Company Metrics for Zai Lab Limited here>>> Shares of Zai Lab Limited have returned -1.8% over the past month versus the Zacks S&P 500 composite's +11.4% change. The stock currently has a Zacks Rank #4 (Sell), indicating that it could underperform the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Zai Lab Limited Unsponsored ADR (ZLAB) : Free Stock Analysis Report This article originally published on Zacks In...

Investor releaseQuarter not tagged2026-05-07

Zai Lab Announces First Quarter 2026 Financial Results and Recent Corporate Updates

Business Wire

– Total revenues of $99.6 million for the first quarter of 2026, reflecting anticipated first-quarter dynamics, including certain competitive impacts for ZEJULA and pricing adjustment related to NRDL renewal for VYVGART – Zocilurtatug pelitecan (zoci) delivered standout data at AACR 2026, with a 62.5% confirmed intracranial ORR in SCLC patients with brain metastases, and clinically meaningful activity (38.2% confirmed ORR) across epNECs; registrational DLLEVATE trial ongoing with enrollment expected to complete in the first half of 2027 – Collaborations with Amgen and Boehringer Ingelheim to evaluate zoci in combination with tarlatamab in SCLC and obrixtamig in SCLC and other NECs, positioning zoci as a potential backbone therapy – ZL-1503 (IL-13/IL-31Rα) demonstrated rapid, durable dual-pathway activity in preclinical data presented at IMMUNOLOGY2026, supporting less frequent dosing and broad potential across atopic diseases, including asthma; Phase 1/1b study underway with initial data expected in 2026 – KarXT launch preparations are underway and TIVDAK remains under regulatory review; positive Phase 3 readouts for povetacicept in IgAN and elegrobart in TED providing additional growth opportunities for our regional business Conference call and webcast today, May 7, 2026, at 8:00 a.m. ET (8:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass., May 07, 2026--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the first quarter of 2026, along with recent product highlights and corporate updates. "We continue to accelerate the development of our global pipeline, with numerous clinical trials underway across oncology and immunology," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "During the quarter, we made strong progress advancing zoci, with AACR data reinforcing its differentiated profile in both SCLC and epNECs, collaborations with Amgen and Boehringer Ingelheim to evaluate zoci as a potential backbone therapy, and rapid enrollment in the registrational DLLEVATE study, which is on track to be fully enrolled in the first half of 2027. We also continue to advance our growing portfolio of global clinical programs, including ZL-1503 (IL-13/IL-31Rα) for atopic dermatitis. This reflects the strength of our R&D engine, which is designed to scale and deliver a pipeline of differentiated new prod...

TranscriptFY2026 Q12026-05-07

FY2026 Q1 earnings call transcript

Earnings source - 59 paragraphs
Operator

Thank you for standing by, and welcome to Zai Lab's first quarter 2026 financial results conference call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Christine Chiou, Senior Vice President of Investor Relations. Please go ahead, madam.

Christine Chiou

Thank you, operator. Hello, and welcome everyone. Today's earnings call will be led by Dr. Samantha Du, Zai Lab's founder, CEO, and Chairperson. She'll be joined by Josh Smiley, President and Chief Operating Officer, Dr. Rafael Amado, President and Head of Global Research and Development, and Dr. Yajing Chen, Chief Financial Officer. Dr. Shan He, our Chief Business Officer, will also be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, we will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings. We will also refer to adjusted loss from operations, which is a non-GAAP financial measure.

Christine Chiou

Please refer to our earnings release furnished with the SEC on May 7th, 2026 for additional information on this non-GAAP financial measure. At this time, it is my pleasure to turn the call over to Dr. Samantha Du.

Samantha Du

Thank you, Christine. Good morning, and good evening, everyone. Thank you for joining us today. Zai Lab is at a pivotal moment. Since our founding, we have built a fully integrated R&D engine capable of taking assets from discovery through global registrational studies with the ability to design and execute multiple central trials globally. The impact of this investment is beginning to emerge. Our pipeline is expanding, our global assets are generating meaningful data, and our lead asset is in global pivotal stage. We are also leveraging AI and data-driven approaches across the organization to enhance speed, precision, and efficiency, strengthening overall execution and corporate productivity, which we expect will drive further results. Last month at AACR, we presented new data for zoci that reinforced our conviction, including strong efficacy, both systemically and in the brain in patients with small cell lung cancer, alongside a best-in-class safety profile.

Samantha Du

We also announced global collaborations with Amgen and Boehringer Ingelheim to explore zoci as a potential backbone therapy in small cell lung cancer and neuroendocrine carcinomas, two cancer types with significant unmet medical need. In late 2027, we expect to submit our first global BLA to the FDA, a defining milestone that marks our successful transformation to a global biotech company. Beyond zoci, we're building a growing portfolio of global clinical programs, including ZL-1311 for atopic dermatitis, now in a phase I-B study. This reflects the strength of our R&D engine, which combines rigorous science with operational speed and efficiency to advance differentiated assets into global development. Our reasonable business remains commercially profitable with a strong balance sheet.

Samantha Du

We're focused on strengthening our commercial capabilities and execution, and I'm pleased to welcome Dr. Yizhe Wang as an Operating Partner to work with me to drive commercial performance and readiness ahead of upcoming launches. The recent policy developments in the region, including the State Council directive, signal meaningful government support for innovative medicines, and we believe Zai Lab is well-positioned to benefit over the medium to long term. Given our first-in-class portfolio, we're confident in Zai's future, which will be defined by our growing global and regional pipeline of differentiated assets. With that, I'll now turn the call over to Rafael.

Rafael Amado

Thank you, Samantha. For the past years, we have built a globally integrated R&D engine that spans from discovery through global registrational development while also delivering on regional development across therapy areas. Our ability to design and execute high-quality global studies with speed and discipline is a core strength that positions us well for development across regulatory geographies. We are embedding AI in R&D, including drug discovery and clinical trial design, to enhance the quality of our decisions and to more efficiently advance our pipeline. The data we presented at AACR last month highlights the output of this engine across all our global pipeline that included both externally sourced and internally discovered products. Let me start with zoci.

Rafael Amado

In extensive-stage small cell lung cancer at the go-forward dose of 1.6 milligrams per kilogram, zoci demonstrated a confirmed intracranial overall response rate of 62.5%. A best overall intracranial response rate approaching 69%, including 4 complete responses. Grade 3 or higher treatment-related adverse events were approximately 16%. Responses of this magnitude inside the brain in one of the most treatment-resistant tumor types in oncology are meaningful signals of differentiation. The safety data reinforce what we have consistently observed. This is a best-in-class profile. A registrational phase III DLLEVATE study is enrolling well and is on track to complete enrollment in the first half of 2027, positioning us for an interim analysis and potential accelerated approval submission next year.

Rafael Amado

In extrapulmonary neuroendocrine carcinoma, a setting where there is no established standard of care in the second line and beyond, zoci demonstrated a confirmed ORR of 38.2%. This compares favorably to currently used regimens, which typically show response rates of approximately 18% with limited durability. We're actively engaging with regulators on a potential registrational path and are well on our way recruiting into an extension single-arm study. Depending on the outcomes of regulatory discussions, we could initiate a registrational or confirmatory study by year-end. Now on the collaborations with Amgen and Boehringer Ingelheim, exploring zoci in combination with T-cell engagers. The scientific rationale is straightforward. zoci delivers rapid tumor debulking through targeted cytotoxicity, while T-cell engagers drive antigen-dependent immune-mediated killing. The mechanisms are complementary.

Rafael Amado

The toxicity profiles are expected to have limited overlap. Together, they have the potential to deepen and extend responses in ways neither mechanistic approach achieves alone. A phase I with Amgen, which includes a cohort of untreated patients with triple combination of zoci, IMDELLTRA, and Imfinzi, is already enrolling. The BI study is expected to follow in the coming months. We're also evaluating zoci in combination with PDL1, with or without chemotherapy, in a phase I study in first-line small cell lung cancer, with data expected later this year. A chemo-sparing approach may allow for extended treatment duration compared to chemotherapy alone, where patients typically discontinue after 4 cycles. This is the basis of our phase III strategy with IO, which we are actively discussing with regulators. Beyond zoci, our global oncology pipeline continues to advance.

Rafael Amado

ZL 6201, our LRRC15 ADC, is already in the clinic. ZL 1311, our wholly owned MUC17 targeting T-cell engager, is expected to enter the clinic by year-end. We will provide updates as data matures. On the regional oncology side, we submitted a marketing authorization application for Tumor Treating Fields in locally advanced pancreatic cancer and expect an approval for this indication by year-end, and for TIVDAK for cervical cancer in the coming months. Turning to immunology, we recently presented preclinical data for ZL 1503, our IL-13, IL-31Rα bispecific at IMMUNOLOGY2026. The data show rapid and durable inhibition of both IL-13-driven inflammation and IL-31 mediated pruritus across disease models in non-human primates, with sustained effects following single dose.

Rafael Amado

We believe this data supports the potential for differentiated efficacy, less frequent dosing, and broad application across multiple atopic diseases, including asthma, rhinitis, and conjunctivitis. Initial phase I data in healthy volunteers and atopic dermatitis patients are expected in the second half of this year. Finally, in our regional immunology portfolio, our partner, Vertex, reported positive phase III interim results from the RAINIER study of povetacicept in IgA nephropathy, achieving approximately a 50% reduction in proteinuria versus placebo and meeting both the primary and all secondary endpoints. I want to close with a broader point. The progress I've described today reflects a pipeline strategy built on biological rationale, clinical differentiation, and execution, an organization that now has the infrastructure to advance multiple programs simultaneously at speed and across geographies. I look forward to providing those updates.

Rafael Amado

With that, I'll hand it over to Josh.

Josh Smiley

Thank you, Rafael, and hello, everyone. Let me start with our first quarter performance, which reflected Chinese New Year seasonality as well as near-term product-specific dynamics. Starting with ZEJULA, performance in the quarter was impacted by a shift in hospital utilization patterns following volume-based procurement for generic olaparib and some incremental competitive pressure in the PARP inhibitor class. Our first-line positioning remains intact, supported by our label advantage, and we are working hard on stabilizing and driving demand. On VYVGART, physician confidence remains strong and our share within biologics is stable. We delivered double-digit volume growth year-on-year in the quarter, offset by a 12% price discount related to NRDL renewal. On a full year basis, we expect a similar level of volume growth as we continue to shape GMG treatment dynamics. The long-term opportunity stays significant.

Josh Smiley

Biologic penetration in the GMG maintenance setting remains around 15%, suggesting a runway for growth. Upcoming phase III readouts in new indications such as IIM and Sjögren's add potential upside. For XACDURO, patient demand was strong and hospital adoption continued to expand. Performance was constrained by supply, and we expect those constraints may persist through the remainder of the year. That said, the underlying demand is encouraging, and local manufacturing, expected in 2027, should alleviate supply pressure and support meaningful growth and margin expansion over time. Looking ahead, we see a strong set of commercial catalysts. KarXT launches in the second quarter and represents the first novel mechanism for schizophrenia in decades, a significant moment for the approximately 8 million patients living with this disease in China. KarXT's inclusion in national treatment guidelines ahead of launch reflects strong clinical confidence in this therapy.

Josh Smiley

Our focus this year is on physician education and market development, building a strong foundation for the brand. We also anticipate potential regulatory approval for TIVDAK this year and intend to leverage our existing ZEJULA infrastructure to drive commercial synergies and accelerate uptake. More broadly, our late-stage pipeline provides multiple additional growth opportunities in the region. Recent positive phase III readouts for povetacicept in IgAN and elegrobart in thyroid eye disease add further depth to our long-term growth profile, and we see both as meaningful future contributors. Lastly, we are applying AI to sharpen commercial execution from physician targeting and field force optimization to real-time competitive insights, enabling more agile and informed go-to-market decisions. 2026 is about execution, delivering on key launches, stabilizing the portfolio and building momentum. With that, I will now pass the call over to Yajing to take us through our financial results. Yajing?

Yajing Chen

Thank you, Josh. Our quarter one results reflect the near-term dynamics just described. First quarter total product revenue declined 6% year-over-year to $99.6 million, driven by lower ZEJULA sales, partially offset by continued growth from ZEJULA and NUZYRA. While we expect total product revenue to improve sequentially over the next 9 months as underlying demand continues to build, we anticipate near-term pressure for 2026 full year total product revenues with a return to growth in 2027. Turning now to our expenses. Our commitment to financial discipline is reflected in continued execution against our R&D and commercial priorities. We will expand AI utilization from process automation to agentic execution to further improve cost efficiencies.

Yajing Chen

R&D expenses for the first quarter increased 8% year-over-year, driven by increased license fees and clinical trial-related expenses, partially offset by lower personnel compensation expenses due to resource prioritization and efficiency efforts. SG&A expenses increased slightly year-over-year, mainly due to higher general selling expenses. As a result, loss from operations increased by 23% for the quarter to $69.4 million. We ended the quarter with a cash position of $761.3 million. Our regional business is commercially profitable. Our global pipeline continues to progress steadily. Our focus this year remains on strengthening the regional business, executing cross-global pipeline, and deploying capital thoughtfully to support both near-term launches and long-term growth drivers. With a strong balance sheet, we are well-positioned to execute against these priorities. Operator, please open up the line for questions.

Operator

Thank you, dear participants. As a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for your name to be announced. To withdraw your question, please press star one and one again. Please stand by while we compile the Q&A queue. This will take a few moments. Now we're going to take our first question. Just give us a moment, the question comes line of Jonathan Chang from Leerink Partners. Your line is open. Please ask your question.

Jonathan Chang

Hey, guys. Thanks for taking my questions. First question on the zoci collaborations evaluating the combinations with DLL3 T-cell engagers. How do these facilitate your longer-term strategy? Are there other combinations and collaborations that make sense to explore? Second question on the commercial business in China, can you give us a sense for how to think about revenues over the course of the year? Thank you.

Josh Smiley

Hey, good morning, Jonathan. It's Josh. Thank you. I'll ask Rafael to take the first one and then Yajing can take the second.

Rafael Amado

Yes, thanks for the question. This combination, I spoke about the rationale of it during the prepared remarks. The expectation is that we would get better efficacy in terms of responses, durability and eventually, you know, better survival than with each agent alone. We're testing it in second line in tarlatamab naive patients, tarlatamab experienced patients, but importantly also in first line. Our first line study will not include tarlatamab, the pivotal trial, to begin with until we get more data. If the data are positive, we may consider, you know, progressing this and developing it as a, you know, best-in-class regimen.

Rafael Amado

It's really improving the baseline treatment of this disease, with two really very active mechanisms.

Josh Smiley

Thanks, Rafael. Yajing?

Yajing Chen

Yes. Hi, Jonathan. Thanks for the question. As I mentioned before, our revenue in the next nine months, you're going to expect to see some sequential growth. For the full year revenue, we are going to continue express experience some short-term pressure. We are seeing the return to growth in 2027.

Josh Smiley

Thanks, Yajing. Next question operator.

Jonathan Chang

Thank you.

Operator

Yes, of course. Now we're going to take our next question. The next question comes line of Michael Yee from UBS. Your line is open. Please ask your question.

Kyle Yang

Hey, guys. Thanks for taking our questions. This is Kyle Yang for Michael Yee from UBS. 2 for us. The first question is for your upcoming data readout for IL-13 and IL-31, what is the expectation for data, and how do you expect the data set in healthy volunteers to de-risk the asset? When do we expect data from moderate to severe atopic dermatitis patients? The second question is that for your data set in frontline small cell lung cancer in the second half, what is the expectation for that? Also what's good data? How do you pick the go forward regimen in terms of a double it versus triple it? Thank you.

Rafael Amado

Thanks, Kyle. Go ahead, Rafael.

Rafael Amado

With the first question in terms of expectations for ZL-1503, the healthy volunteers data I think is going to be very useful. We actually have progressed the study quickly with those cohorts. We would be looking at safety obviously, pharmacokinetics, you know, to evaluate dosing interval, which we expect to be, you know, prolonged dosing. Pharmacodynamics, such as phospho-STAT and others, an anti-drug antibody. All of these, I think will inform, you know, the basic parameters that will allow us to, you know, continue the development of the product.

Rafael Amado

With regards to what to expect, obviously, it depends on how much data we have on atopic dermatitis, but we should have data on healthy volunteers by the end of the year and at least some of the cohorts with atopic dermatitis. Our expectation is that we may publish this data before the end of the year. With regards to first line, we, the question was what do we consider, you know, as go forward? Well, you know that the chemotherapy plus checkpoint inhibitor, which would be the control of our study, has a PFS of about 5 months or so.

Rafael Amado

Our response rate in second line, with 1.6 milligrams per kilogram is in the order of 68%. Obviously there's still room for improvement there. We will be looking for higher response rates, and also longer PFS than that we believe is clinically significant. And we plan to present this data towards the, you know, fall or so. And by then we should have sufficient follow-up to really be able to evaluate that. We're currently, you know, planning to proceed with this study before the end of the year and in discussions with regulators.

Kyle Yang

Thank you.

Operator

Thank you. Now we're going to take our next question, and it comes line of Anupam Rama from JPMorgan. Your line is open. Please ask your question.

Anupam Rama

Hey, guys. Thanks so much for taking the question. Just with the recent positive data for povetacicept in IGAN, what are the plans to submit in regional China? Just remind us, is there gonna be any bridging work required? Thanks so much.

Josh Smiley

Thanks, Anupam. Okay, Rafael.

Rafael Amado

Yeah. We were very pleased to see the results of the RAINIER study. The really a good advance for IgAN. The filing of our partner has taken place, and we will discuss with CDE what the regulatory requirements for filing. We expect that we would be able to proceed because we did include patients from China in the study. A bridging study is not expected to be required. As our partner, we would discuss with CDE our approach to an accelerated approval with this product.

Anupam Rama

Great. Thanks so much for taking our question.

Operator

Thank you. Now we're going to take our next question. The question comes line of Li Watsek from Cantor. Your line is open. Please ask your question.

Speaker 10

Good morning. This is Vin on for Li. Question about ZL-1503, the bispecific antibody. It seems like data is going to come in the second half of this year. There's a lot of bispecific antibody out there in AD. We'd like to know what's your base assumption on the market differentiation for this drug and also your.

Speaker 10

Give us strategy there? Are you planning to run a phase II trial, or are you potentially going to form a result? Thank you.

Josh Smiley

Rafael, why don't you address that, and I can make a couple commercial comments.

Rafael Amado

Sure. Yeah, in terms of differentiation, you know, as I mentioned, I think long-term dosing is important. We still have to evaluate how often that would be, but we expect that that would be the case for ZL-1503. In terms of activity, you know, the key activity is obviously decreasing pruritus because our product inhibits the IL-31 receptor. We expect using the numerical rating scale that we would have a meaningful decrease in pruritus that's also occurring early on in the treatment. 'Cause I think that's really the important and differentiating from other products. The same for skin pain, which is, you know, something that affects the quality of life of patients.

Rafael Amado

Of course, the main endpoint, which tends to be EASI-75, which you know what the benchmark out there is, you know, in the 40% range. You know, surpassing these numbers, you know, would be together with the extended dosing, something that we would consider, you know, very positive for us to move forward with phase II. As of the question of whether or not we plan to do that, the answer is yes, we plan to do our phase II study and evaluate these parameters as I mentioned before.

Speaker 10

Thank you.

Josh Smiley

Yeah, I think just to comment, it's Josh. Obviously it's a competitive class, but there's lots of room for differentiation still, you know, very undertreated. I think as Rafael said, what we know about patients is, dosing convenience makes a difference. Relief on itch and speed of onset are all important things that will, you know, elucidate over the course of the clinical development program. We're quite excited about the opportunity here. Thanks.

Speaker 10

Thank you.

Operator

Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for a name to be announced. To withdraw a question, please press star one and one again. Now we're gonna take our next question. The question comes to line of Weiyi Chen from Goldman Sachs. Please ask your question. Your line is open.

Ziyi Chen

Oh, great. Thank you for taking my questions. I got a 2 question. The first one is on zoci. We noticed that Amgen has initiated phase I study for tarlatamab plus zoci with and without PDL1 in small cell lung cancer. Could you share a bit more about your thoughts on potential dose levels you're gonna explore, particularly considering for tarlatamab, FDA has actually has a black box in their label. What are the potential dose levels you're gonna be exploring for zoci and also for tarlatamab? And also, have you considered to test a sequential use of those 2 drugs, or instead you're gonna be more focusing on administer those 2 drugs together to patients?

Ziyi Chen

My second question is regarding the efgartigimod in China. Could you please comment on the evolving landscape, given that now Regeneron's telitacicept has been also enrolled into an NRDL, particularly in the first quarter? Have you seen any of the change to the market dynamics? Thank you.

Josh Smiley

Thanks. Rafael, do you wanna start on zoci and then I'll comment on VYVGART?

Rafael Amado

Sure. Thanks for the question. Yeah, the study is actually enrolling now. In terms of the dose levels, we wanted to have a Q3 weekly regimen with both drugs. The dose of tarlatamab will be fixed. We will do, you know, hopefully a rapid dose escalation with zoci up to 1.6 mixture kit, which is the go-to dosing that we have for Elevate, our phase III study in second line. You know, as I mentioned before, this will be in various clinical settings, including the triplet combination with checkpoint inhibitors, as you mentioned, in front line and 3 patients.

Rafael Amado

In terms of whether it's sequential versus together, there's, you know, Given the mechanism of action, you know, we want the rapid devolving to be present when the T-cell engager is given. They're given in fast sequence. We're not gonna test, you know, alternating sequences or other schedules. I hope that that helps. Thanks for the question.

Josh Smiley

Thanks, Rafael. On VYVGART, at first, as we mentioned, we're seeing, you know, double-digit volume increases in Q1 as a function both of new patients continuing to come in and get started and extending duration of therapy. That being said, there's still only about 15% of patients with that would qualify for a biologic therapy in GMG are getting it. I think having, you know, additional competition is fine. We don't really see an impact from telitacicept to any measurable degree in Q1. Again, we would expect as we get through the year that continuing to emphasize getting patients with GMG on to biologic therapy and getting them the benefits of longer term maintenance is gonna help everybody. That's what we're focused on. Thanks.

Ziyi Chen

Thank you.

Operator

Thank you. Dear participants, as a final reminder, if you would like to ask a question, please press star one one. Dear speakers, those are further questions for today. I would now like to hand the conference over to your speaker, Samantha Du, for any closing remarks. Samantha, please go ahead.

Samantha Du

Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you again after the second quarter of 2026. Operator, you may now disconnect this call. Thank you.

Operator

This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.

Investor releaseQuarter not tagged2026-04-22

Zai Lab to Announce First Quarter 2026 Financial Results and Recent Corporate Updates on May 7, 2026

Business Wire

- Company to host conference call and webcast on May 7, 2026, at 8:00 a.m. ET (8:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass., April 22, 2026--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report its first quarter 2026 financial results and provide recent corporate updates on May 7, 2026, before the opening of U.S. equity markets. The announcement will be followed by a conference call and webcast at 8:00 a.m. ET (8:00 p.m. HKT). Conference Call and Webcast Information The live webcast can be accessed by visiting the Company's website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details are as follows: Registration link for webcast (preferred): https://edge.media-server.com/mmc/p/s7q4ox5h Registration link for dial-in: https://register-conf.media-server.com/register/BI802954894429400baf012f775762af29 All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering. A replay will be available shortly after the call and can be accessed by visiting the Company's website. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.X.com/ZaiLab_Global. View source version on businesswire.com: https://www.businesswire.com/news/home/20260422384100/en/ Contacts For more information, please contact: Investor Relations: Christine Chiou / Cyan Liu +1 (917) 886-6929 / +86 195 3130 8895 [email protected] / [email protected] Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015 5011 [email protected] / [email protected]

Investor releaseQuarter not tagged2026-02-28

Zai Lab Q4 Earnings Call Highlights

MarketBeat

zoci is in a global registrational Phase III for second/third‑line SCLC (~480 patients) with Zai targeting an accelerated approval submission in 2027 and a first global approval in 2028, and the program has shown notable intracranial activity (an 80% ORR in 10 untreated brain metastasis patients) with ~75% enrollment expected by end‑2026. Zai’s commercially profitable China business is funding global R&D while fourth‑quarter revenue rose 17% YoY to $127.6 million (full‑year $460M), operating loss improved 19% to $229.4M, and the company closed the quarter with $790 million in cash as it pursues a corporate cash‑flow breakeven objective. The broader global pipeline is advancing with U.S. IND clearance for ZL‑6201, IND‑enabling work for ZL‑1222, a planned ZL‑1311 IND by year‑end, enrollment of ZL‑1503 with first‑in‑human data expected in 2026, plus near‑term readouts including a povetacicept interim analysis and REVEAL TED top‑line results in early/mid‑2026. Interested in Zai Lab Limited Unsponsored ADR? Here are five stocks we like better. Zai Lab Stock Has Fallen to Value Levels Zai Lab (NASDAQ:ZLAB) executives used the company’s fourth-quarter and full-year 2025 earnings call to outline progress toward a more globally oriented pipeline while emphasizing that the company’s China commercial business remains a key source of stability and funding for research and development. Founder, CEO, and Chairperson Dr. Samantha Du said Zai Lab is “building a company increasingly defined by global innovation,” supported by a “commercially profitable China business and R&D infrastructure.” She highlighted the company’s global oncology and immunology pipeline as reaching “a scale and maturity that fundamentally changes the profile of this company,” and pointed to a “clear path toward our first potential U.S. approval by 2028.” → SoundHound’s New Sales Assist Agent Put Voice AI Back in the Spotlight President and Head of Global R&D Dr. Rafael Amado detailed progress for zoci (a DLL3-targeting antibody-drug conjugate), which the company is advancing in small cell lung cancer (SCLC) and neuroendocrine carcinomas (NECs). Amado said Zai initiated a global registrational phase III study in second- and third-line SCLC designed to enroll about 480 patients. The control arm is intended to reflect “real-world global practice,” including topotecan, lurbinectedin, or amrubicin. Amado s...

Investor releaseQuarter not tagged2026-02-27

Zai Lab Ltd (ZLAB) Q4 2025 Earnings Call Highlights: Strong Revenue Growth and Strategic ...

GuruFocus.com

This article first appeared on GuruFocus. Fourth Quarter Revenue: $127.6 million, a 17% year-over-year increase. Full Year Revenue: $460.2 million, representing 15% year-over-year growth. R&D Expenses: Declined 6% for the full year. SG&A Expenses: Decreased 12% for the fourth quarter and 7% for the full year. Loss from Operations: Improved 19% for the full year to $229.4 million. Adjusted Loss from Operations: Improved 25% excluding non-cash expenses. Cash Position: Ended the quarter with $790 million. Warning! GuruFocus has detected 8 Warning Signs with ZLAB. Is ZLAB fairly valued? Test your thesis with our free DCF calculator. Release Date: February 26, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Zai Lab Ltd (NASDAQ:ZLAB) reported a 15% year-over-year growth in full-year revenue, demonstrating resilience despite a challenging macro environment. The company has advanced its global oncology immunology pipeline rapidly, with zoci reaching pivotal stage trials and a potential US approval by 2028. Zai Lab Ltd (NASDAQ:ZLAB) has a strong cash position, ending the quarter with $790 million, which supports its strategic initiatives and growth plans. The company is leveraging its integrated US and China development model to accelerate clinical trials and achieve faster, more capital-efficient execution. Zai Lab Ltd (NASDAQ:ZLAB) is focused on expanding its global pipeline with innovative assets, including a promising IL-13/IL-31R bispecific program in atopic dermatitis. The company faces pricing dynamics and evolving competition, which may impact near-term growth for products like VYVGART. Zai Lab Ltd (NASDAQ:ZLAB) is navigating supply constraints that have limited the full realization of demand for certain products. There is uncertainty regarding the regulatory pathway for zoci in neuroendocrine carcinomas, as discussions are ongoing about whether a single-arm study will suffice for approval. The company is experiencing variability in hospital purchasing patterns, which could affect revenue projections. Zai Lab Ltd (NASDAQ:ZLAB) has not provided full-year guidance for 2026 due to several moving pieces, including price adjustments and rebate dynamics. Q: Can you provide any color on how we should be thinking about revenues and expenses for 2026? Also, what are the implications of the intracranial activity...

Investor releaseQuarter not tagged2026-02-26

Zai Lab Announces Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Updates

Business Wire

– Total revenues grew 17% y-o-y to $127.6 million for the fourth quarter of 2025 and 15% y-o-y to $460.2 million for the full-year 2025 – Zocilurtatug pelitecan (zoci) on track to become Zai Lab’s first global oncology launch, with three registration-enabling studies across 2L+ SCLC, 1L SCLC, and extrapulmonary NECs by the end of 2026 – Advancing a differentiated global pipeline, including ZL-1503 (IL-13/IL-31Rα), ZL-6201 (LRRC15 ADC), ZL-1222 (PD-1/IL-12) and ZL-1311 (MUC17/CD3 TCE) – Key regional programs continue to advance, with KarXT approved in China and commercial launch preparations underway; pivotal data readouts for povetacicept in IgAN and elegrobart in TED expected in 2026 Conference call and webcast today, February 26, 2026, at 8:00 a.m. ET (9:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass., February 26, 2026--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the fourth quarter and full-year 2025, along with recent product highlights and corporate updates. "2025 was a year of disciplined execution across both engines of our business with significant advancement across our global innovation pipeline and steady progress in our commercial business," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "We accelerated multiple global programs, including the rapid progression of zoci into pivotal development, enabled by our integrated U.S./China infrastructure which allows us to operate with speed and capital efficiency. In 2026, our focus is on executing against important catalysts – advancing late-stage immunology and oncology programs while preparing for the next wave of commercial growth. Together, these efforts mark an important step in Zai Lab’s continued evolution into a global biopharma leader." "KarXT represents a significant new growth driver for Zai Lab, and its recent inclusion in a national expert consensus underscores the growing recognition of its novel mechanism and potential to meaningfully impact patients living with schizophrenia," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "We are strengthening the VYVGART franchise by expanding hospital coverage and supporting longer treatment persistence. Concurrently, we are preparing for the potential approvals of TIVDAK, which would further strengthen our women’s health franchise, and TTFields in p...

Investor releaseQuarter not tagged2026-02-26

Zai Lab Limited (ZLAB) Q4 Earnings: How Key Metrics Compare to Wall Street Estimates

Zacks

For the quarter ended December 2025, Zai Lab Limited Unsponsored ADR (ZLAB) reported revenue of $127.6 million, up 17% over the same period last year. EPS came in at -$0.46, compared to -$0.80 in the year-ago quarter. The reported revenue represents a surprise of +6.85% over the Zacks Consensus Estimate of $119.42 million. With the consensus EPS estimate being -$0.44, the EPS surprise was -4.55%. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance. Here is how Zai Lab Limited performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Product Revenue, net: $127.09 million compared to the $132.11 million average estimate based on three analysts. Product Revenue- XACDURO: $10.7 million versus the two-analyst average estimate of $9.6 million. Product Revenue- VYVGART: $21.9 million compared to the $39.74 million average estimate based on two analysts. The reported number represents a change of -27% year over year. Product Revenue- NUZYRA: $16 million versus $17.22 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a +45.5% change. Collaboration revenue: $0.51 million compared to the $19.34 million average estimate based on two analysts. Product Revenue- ZEJULA: $56 million versus the two-analyst average estimate of $49.17 million. The reported number represents a year-over-year change of +15.7%. View all Key Company Metrics for Zai Lab Limited here>>> Shares of Zai Lab Limited have returned +12.7% over the past month versus the Zacks S&P 500 composite's +0.6% change. The stock currently has a Zacks Rank #4 (Sell), indicating that it could underperform the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Zai Lab Limited Unsponsored ADR (ZLAB) : Free Stock Analysis Repo...

TranscriptFY2025 Q42026-02-26

FY2025 Q4 earnings call transcript

Earnings source - 45 paragraphs
Operator

Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's Fourth Quarter and Full Year 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, today's call is being recorded. It's now my pleasure to turn the floor over to Christine Chiou, Senior Vice President of Investor Relations. Thank you. Please go ahead.

Christine Chiou

Thank you, operator. Hello, and welcome, everyone. Today's earnings call will be led by Dr. Samantha Du, Zai Lab's Founder, CEO and Chairperson. She will be joined by Josh Smiley, President and Chief Operating Officer; Dr. Rafael Amado, President and Head of Global Research and Development; and Dr. Yajing Chen, Chief Financial Officer. Dr. Shan He, our Chief Business Officer, will also be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, we will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings. We will also refer to adjusted loss from operations, which is a non-GAAP financial measure. Please refer to our earnings release furnished with the SEC on February 26, 2026, for additional information on this non-GAAP financial measure. At this time, it is my pleasure to turn the call over to Dr. Samantha Du.

Ying Du

Thanks, Christine. Good morning, and good evening, everyone. Thank you for joining us today. Zai Lab is at an important point in our evolution. We are building a company increasingly defined by global innovation, resting on a foundation supported by a commercially profitable China business and R&D infrastructure. Today, our global oncology, immunology pipeline is reaching a scale and maturity that fundamentally changes the profile of this company. We have multiple global programs advancing rapidly through the clinic and with zoci in pivotal stage. We see a clear path toward our first potential U.S. approval by 2028. Importantly, we advanced zoci from IND to global Phase III in less than 2 years, an industry-leading pace that reflects the strength of our integrated U.S. and China development model. This capability enables faster, more capital-efficient execution, is now being applied across our broader pipeline. Our China business continues to provide stability and leverage for our global R&D efforts. Despite a challenging macro and operating environment, full year revenue grew 15% year-on-year, and our commercial profitability continues to improve. Looking ahead to 2026, our priorities are very clear. This is a year focused on execution and preparation. We expect several meaningful pipeline catalysts, including clinical data for zoci in brain metastasis, neuroendocrine carcinoma and first-line small cell lung cancer as well as first-in-human data from our IL-13/IL-31 receptor bispecific program in atopic dermatitis. On the regional side, we have important pivotal data readouts for large opportunities such as povetacicept in IgAN and elegrobart in thyroid eye disease, both of which enhance the durability of our China growth engine. Business development remains an important lever for us. Our presence and capabilities in China provides access to one of the world's most important fast-evolving innovation ecosystems, creating opportunities that can meaningfully strengthen and prioritize both our global and regional pipeline. Ultimately, our objective is to build a company that can make a lasting difference for patients while creating substantial value for shareholders. With that, I'll now hand the call over to Rafael, who will walk you through the progress of our R&D pipeline. Rafael?

Rafael Amado

Thank you, Samantha. 2025 was a year of significant progress for our R&D organization as we continue to build globally competitive pipeline. Over the course of the year, we initiated a pivotal trial in oncology, advanced one additional oncology program into the clinic and moved our lead immunology asset into clinical development. With that, I'd like to walk you through our progress, starting with zoci, our potential first and best-in-class DLL3-targeting ADC and a cornerstone of Zai Lab's global oncology portfolio. In second-line and third-line small cell lung cancer, we have initiated a global registrational Phase III study, which will enroll approximately 480 patients across second-line post-platinum and third-line post-tarlatamab settings with a control arm reflecting real-world global practice, including topotecan, lurbinectedin or amrubicin. Importantly, zoci has advanced at a rapid pace, significantly faster than is typically observed for programs in this space. Based on current time lines, we anticipate a potential accelerated approval submission in 2027 and our first global approval in 2028. Clinically, zoci has demonstrated encouraging efficacy in heavily pretreated extensive-stage small cell lung cancer, including an 80% objective response rate in 10 patients with untreated brain metastases. The ability to treat both intracranial and extracranial disease without treatment interruptions represent a meaningful potential advantage for patients, and we look forward to presenting this data in the coming months. Equally important, zoci continues to stand out for its favorable safety profile with low rates of severe treatment-related adverse events. We believe this profile supports zoci's potential role as a backbone ADC in first-line combination regimens, including those that reduce chemotherapy burden. We plan to initiate a first-line pivotal trial in small cell lung cancer and to advance zoci into additional novel combination regimens before year-end. Beyond small cell lung cancer, we see a compelling opportunity for zoci in neuroendocrine carcinomas or NECs, a large underserved population with no approved DLL3-targeted therapies. Enrollment in our global Phase Ib/II is progressing very well, and we plan to present initial data this year with the goal of initiating a registration-enabling study by the year-end. Taken together, we believe zoci's differentiated efficacy and safety profiles, including activity in brain metastases, positions it to address a significant unmet need across small cell lung cancer and neuroendocrine carcinomas where the total addressable global market is estimated to exceed $9 billion. Beyond zoci, our next wave of innovative global assets continues to advance rapidly. ZL-6201, our internally discovered LRRC15-targeting ADC, received U.S. IND clearance and the global Phase I study was quickly initiated thereafter. ZL-1222, our PD-1/IL-12 immunocytokine is progressing through IND-enabling studies and ZL-1311, a next-generation T-cell engager or TCE targeting MUC17, represents our first globally owned TCE with an IND planned by year-end. In immunology, ZL-1503 is our internally discovered IL-13/IL-31 receptor alpha bispecific antibody for atopic dermatitis and is designed to address both itch and inflammation with the potential for enhanced and faster onset of efficacy associated with less frequent dosing than current biologics. The global Phase I/Ib study is enrolling well, and we expect first-in-human data later this year. Now turning briefly to our key late-stage regional programs, starting with our immunology portfolio. Efgartigimod continues to expand across multiple autoimmune indications with ongoing development across a broad clinical program. Recent late-stage results support further label expansion and additional Phase III readouts are expected this year and next with China being a valuable contributor to global enrollment. Povetacicept remains on track with an interim analysis for the global RAINIER Phase III study for IgAN planned for the first half of 2026, and enrollment is ongoing in the global pivotal OLYMPUS Phase II/III study for primary membranous nephropathy. Lastly, for elegrobart, our partner, Viridian expects to report top line data for the global registrational REVEAL-1 study in active TED. This will be in the first quarter of 2026, followed by top line results from the global registrational REVEAL-2 study in chronic TED in the second quarter of 2026. Elegrobart has the potential to become the first subcutaneous IGF-1R therapy approved for TED in China. Turning to our local oncology portfolio. For TIVDAK, we expect approval in China in the first half of 2026, which will build naturally on our established ZEJULA commercial platform, further deepening our leadership in women's cancers. Finally, for Tumor Treating Fields, the FDA approval for Optune Pax in locally advanced pancreatic cancer earlier this month represents an important milestone in this disease, and we will work closely with China's NMPA under the innovative medical device pathway to support an expedited review. Together, these achievements reflect the depth and quality of our pipeline, one that is advancing with speed and efficiency. And with that, I'll hand it over to Josh.

Joshua Smiley

Thank you, Rafael, and hello, everyone. Before getting into quarterly performance by product, I want to briefly frame how the business progressed more broadly in 2025. During the year, we made important progress across market access, portfolio optimization and business development. We successfully completed NRDL renewals for key products and achieved guideline updates supporting VYVGART in generalized myasthenia gravis and KarXT in schizophrenia, both of which strengthen the durability of our commercial portfolio over the long term. At the same time, we sharpened our focus by divesting noncore assets and regions, allowing us to reallocate resources toward higher priority growth opportunities and to improve operational efficiency. From a business development perspective, we maintained a highly selective and strategic approach. During the year, we entered targeted collaborations to explore novel combination strategies in first-line small cell lung cancer and strengthen our oncology platform with the addition of a MUC17/CD3 T-cell engager. Together, these actions reflect our disciplined approach to external innovation, complementing our internal pipeline while preserving financial flexibility. With that broader context, I'll now turn to our quarterly commercial performance. Fourth quarter revenues increased 17% year-over-year to $127 million, and full year revenues grew 15% to $460 million, reflecting steady progress across our commercial portfolio. Starting with VYVGART. Physician confidence remains strong and patient demand has been stable. Fourth quarter revenues, however, reflected channel dynamics related to NRDL renewal and hospital purchasing patterns. In 2026, we expect a more measured near-term growth profile influenced by pricing dynamics and evolving competition. The long-term trajectory of the franchise remains intact, supported by clinical guideline expansion, affordability initiatives and additional indications and formulations. Turning briefly to ZEJULA. We delivered a strong fourth quarter driven by first-line BRCA-positive new patient starts. While some variability is expected early in the year due to volume-based procurement dynamics for olaparib and seasonality, ZEJULA remains well positioned in the first-line setting. Looking ahead, KarXT represents a significant near-term growth opportunity. We expect to initiate the commercial launch in the second quarter of 2026 with a clear focus on disciplined execution, building disease awareness, establishing clinical confidence and laying the groundwork for broader adoption. Recent inclusion in a national expert consensus on negative symptom management builds on last year's inclusion in national treatment guidelines and reinforces growing recognition of KarXT's profile. In summary, 2026 is a year focused on maintaining the strength and stability of our existing business while preparing for multiple growth opportunities ahead. That includes continuing to build the VYVGART franchise, executing a high-quality launch for KarXT in schizophrenia and advancing key late-stage assets such as povetacicept in IgAN, elegrobart in TED and TTFields in pancreatic cancer. The investments we are making across commercial and R&D today are designed to support a multiyear growth trajectory extending well beyond 2026. And with that, I will now pass the call over to Yajing to take us through our financial results. Yajing?

Yajing Chen

Thank you, Josh. Now I will discuss highlights from our fourth quarter and full year 2025 financial results compared to the prior year period. Fourth quarter total revenue grew 17% year-over-year to $127.6 million, driven by strong contributions from XACDURO and NUZYRA. XACDURO performance reflected strong patient demand and expanding hospital adoption, though supply constraints during the year limited the full realization of underlying demand. NUZYRA continued to benefit from broader market coverage and increased penetration. Total revenues for the full year were $460.2 million, representing 15% year-over-year growth. Turning now to our expenses. Our commitment to financial discipline is reflected in improved operating leverage with both R&D and SG&A declining as a percentage of revenue year-over-year. R&D expenses for the full year declined 6%, driven by lower personnel compensation costs and increased in the fourth quarter due to fast progression of global clinical trials. SG&A expenses decreased 12% and 7% year-over-year for the fourth quarter and full year, mainly due to the reduction in general and administrative expenses because of strategic resource optimization. As a result, loss from operations improved 19% for the full year to $229.4 million and improved 25% when adjusted to exclude noncash expenses, including depreciation, amortization and share-based compensation. We maintain a strong cash position, ending the quarter with $790 million. Looking to 2026, our focus remains on strengthening the foundation of our regional business, executing across our global pipeline and thoughtful capital deployment to support both near-term launches and the long-term growth drivers. With a strong balance sheet, we are well positioned to execute against these priorities. And with that, I would now like to turn the call back over to the operator to open up lines for questions. Operator?

Operator

[Operator Instructions] Our first question comes from the line of Jonathan Chang of Leerink Partners.

Jonathan Chang

First question, can you provide any color on how we should be thinking about revenues and expenses for 2026? And then second question on the global pipeline for zoci, can you remind us of the implications of the intracranial activity in patients with brain mets? And how does this impact the opportunity and positioning of the drug?

Joshua Smiley

Thanks, Jonathan. It's Josh. I'll start with 2026, ask Yajing to make a comment, and then we'll hand it over to Rafael to talk about zoci. I think as we think about 2026, as we mentioned on the upfront comments, we see good growth opportunities for VYVGART. We're seeing good volume gains throughout the second half of the year. We expect that to continue in 2026. We're pleased with how we're -- how we ended the year with ZEJULA. And while we're facing a generic market now for Lynparza, we expect to continue to hold our position and in some cases, hopefully grow. XACDURO should be a good driver for us this year. And of course, then we've got a couple of important launches coming. COBENFY in the second quarter, we will begin our commercial launch and then TIVDAK later this year. So I think when you think about those things together, certainly, we're looking for good commercial performance and good growth on the top line for the year. For expenses, I think we're in good shape on SG&A, very modest investments required to support launches. Obviously, we're going to put the field sales force in place to launch COBENFY, and that will drive some incremental costs. But I think otherwise, we're in good shape as it relates to synergies and efficiencies across our SG&A. R&D should be relatively in line with what we've seen in the last few years. Obviously, big focus and resource allocation to our global portfolio. But as some of our late-phase opportunities start to -- in China start to come offline, we've got capacity there. So I think sort of flat to very modest growth in R&D. So this year, pretty straightforward thinking. Obviously, we've got some pushes and pulls as it relates to when things are approved and when we get them into the market and otherwise. I think then as we think about '27 and on, we'll start to get the benefits of these launches like COBENFY and TIVDAK and some of the assets that Rafael talked about in his upfront comments. Yajing, I don't know if you want to add anything to that?

Yajing Chen

Maybe just to add a little bit more dynamics in 2026. I mean 2026 is a transition year. I think underlying demand growth, as Josh talked about, is very true. Also, we want to be mindful of other dynamics, moving pieces, including the IV -- the VYVGART IV price adjustment and maybe later on the rebate dynamics in the fourth quarter for VYVGART, the Hytrulo. So -- and then we are sort of like looking at the hospital budgeting purchasing behavior as well. So this is part of the reason that we want -- we are probably not going to provide the full year guidance at this time, but those are the moving pieces. When we get more clarity, we can share more specifics later in the year.

Joshua Smiley

Thanks, Yajing. Rafael, do you want to talk about zoci, please?

Rafael Amado

Yes, absolutely. So brain metastases, obviously, in this disease is a big problem. About 70% of patients develop brain metastases. And I think the speed with which patients' experience responses with zoci is well appreciated among investigators and it's actually one of the key properties of the molecule. So we've reported up to 80% response rates in patients with untreated metastases. So there are 2 situations. If a patient comes in with brain metastases, oftentimes, they have to have brachytherapy or some local regional therapy, which delays systemic therapy, whereas if it's an uncomplicated untreated met, patients can go into zoci directly. And we see, again, pretty high activity in the brain. The other is there are some drugs that may have activity, but then there is a high rate of relapse in the brain where the brain is a sanctuary site. So using zoci prevents recurrences in the brain, which is really important. So we've reported in RECIST criteria before, and we're planning to report now in the first half of the year using RANO criteria, which is a response assessment that is used in neuro-oncology is a much more stringent one where it's bidimensional and uses 50% instead of 30%. So it really characterizes the responses in the brain, and we look forward to presenting that in the first half of this year.

Operator

[Operator Instructions] Our next question comes from the line of Li Watsek from Cantor.

Li Wang Watsek

I guess my first question is more about sort of the U.S.-China development model that you alluded to in the opening. So I just wonder, can you elaborate a little bit more other than maybe sourcing assets from the region? I guess, how much clinical derisking or time line acceleration can you achieve by leveraging some of the resources in the region?

Joshua Smiley

Thanks, Li. It's Josh. Rafael, why don't you talk a little bit about this point to Li's question?

Rafael Amado

Sure. So our model obviously has been speedy development in China based on pretty efficient development structure as well as regulatory and other functions in China, and that's led to the success of registrations local regionally. And now we're applying that speed, relationship with investigators and sites to add China to global trials or to be the sole site when we want go/no-go decisions with products. So we now have all our global trials really, including China participation, and that really has allowed us to move with speed and quality. So, that will be also the case for Phase III studies. We expect that China will participate and enroll about 1/3 of the patients, at least that's our expectation, for instance, on our current pivotal trial in second-line with zoci. So I think all in all, this efficiency that we have built over the course of the past 10 years in China is serving us well as we are now expanding our pipeline towards global assets. And we are seeing the fruits of that by, for instance, zoci moving within 2 years to Phase III from IND as an example.

Li Wang Watsek

Okay. And then my second question is on zoci. And obviously, you guys are going to present data in neuroendocrine. So just wanted to get a little color in terms of expectations, what sort of data you guys going to present, what's good data? And in terms of regulatory pathways, can you maybe just conduct a single-arm study to get approval, maybe expand a little on that as well?

Rafael Amado

Yes. NEC is a complex group of diseases and first-line is treated with chemotherapy. There is the gastroenteropancreatic subgroup and then other neuroendocrine carcinomas that exclude lung because lung tends to have a different prognosis. And when you look across the board in second-line, chemotherapy really has dismal activity in terms of response rate and PFS. So our study has started in second-line and is looking at GEP, neuroendocrine carcinoma, non-GEP neuroendocrine carcinomas or extrapulmonary. And then there's a group that is looking at neuroendocrine tumors, which are less aggressive. So an initial data set will be presented in second-line. We are pleased with what we're seeing thus far. We will have, I think, sufficient patients to make an assessment in terms of the response. The durability may be limited, but we think that there's enough information there to present in the first half of this year. And there may be about 60-plus patients that will be included in this analysis. Like you said, we are sort of ourselves seeking a regulatory path for NEC in second-line. And this is actually the subject of regulatory discussions that we're initiating now in terms of whether a single-arm would be sufficient or whether a randomized trial would be required. It's unclear what the control arm would be in the second option, but it's still a possibility. So those discussions are beginning now as we uncover the data. And we're also thinking about what to do in frontline as well. As you know, some T-cell engagers are getting into this space, and we would probably consider something in first-line in combination, but that is standalone in the future. We want to sort of see what we can do to help patients in second-line where options are just scarce.

Operator

[Operator Instructions] Our next question comes from Michael Yee of UBS.

Michael Yee

We have 2 questions. First, just wanted to understand, given all the thoughts and comments you have talked about regarding steady revenue growth and pushes and pulls as it relates to financials this year. Does the company believe that they could achieve breakeven or profitability by the end of the year? Do you think that's something that is achievable given what we had expectations for last year? And then the second question is, obviously, zoci and DLL3 are critically important. What is the expectation for completion of enrollment and the timing of reading out the primary endpoint on response rate in order to file?

Joshua Smiley

Great. Thanks, Mike. How about Yajing, you talk about the cash flow, and then we'll hand it over to Rafael.

Yajing Chen

Yes. So our corporate profitability, I mean the cash flow breakeven is definitely continue to be a very clear objective for Zai Lab. We will manage the business accordingly. Our business right now is commercially profitable today. That provides a stable foundation for the company. At the corporate level, I think the timing of the profitability is really driven by the 2 primary factors. One is the top line growth, the rate of the growth and the other one is the level of investment that we choose to make in the high-value global programs. So I think at this time, we remain efficient, disciplined in our spending. We do expect the corporate profitability to emerge. I won't be able to share the guidance for 2026, where we're going to be, but that's definitely the goal for us to continue to drive. And also, I want to mention that we are focused on progressing towards the goal, but also focus on continue to expand our global pipeline. So we do want to preserve the flexibility to invest when we see the strong value.

Joshua Smiley

Thanks, Yajing. Go ahead, Rafael.

Rafael Amado

Thanks, Josh, and thanks, Michael, for the question. So the study started in December. It's a global trial. It started in the U.S. first, and China is coming online imminently as Europe will and North America and other countries in Asia as well, Asia Pacific. Our plan is to have about 75% of the patients enrolled by the end of the year. We have to have everybody enrolled before we do the interim analysis for response. And we think that we will finish enrollment at the end of the first quarter of next year and do the analysis and subsequently file. So we're hoping for an approval in 2028. And the study, as you know, is a combination of second-line as well as post-tarlatamab patients, and we're balancing the accrual of each one of those subgroups in the study. So 2027 end of accrual and filing and 2028, hopefully, accelerated approval.

Operator

[Operator Instructions] Our next question comes from Yigal Nochomovitz from Citigroup.

Caroline DePaul

This is Caroline on for Yigal. Could you talk about your strategy to grow VYVGART, specifically how to increase cycles per patient?

Joshua Smiley

Thanks, Caroline. VYVGART, we are focused on moving the cycles per patient to the minimum of 3, which is what's embedded in the national myasthenia gravis guidelines in China that were updated in July of last year. Of course, in the clinical data, getting out to 5 or more over a 12-month period demonstrates really significant benefits. But our focus right now is on 3. We're making reasonable progress, and we made reasonable progress in 2025. We -- if you just look at average cycles closing out the year in 2025, we improved versus 2024 by more than 50%. So we're on the way, but we're not yet on average at 3. So I think we've got a couple of key initiatives to help drive that focus. I mean the first is to leverage the guidelines, and that's through our medical professionals and our sales professionals. And I think that's really important, and we're seeing the benefit of that. We know guidelines make a big difference in China. They make a big difference in most markets. And this has been just -- it's been a build the market approach with VYVGART. So I think we're making good progress there and certainly have the clinical data and now the national guidelines to support that. We are also working on affordability initiatives, while NRDL listing is clear for VYVGART, patients do pay co-pay and pay out of pocket. So we've got in place an online support program that helps patients navigate things like appointments and resources and otherwise to help on the logistics and the co-pay. We have a targeted co-pay assistance program that helps, and it really is focused on the national guidelines and focused on ensuring we can get patients out to 3 cycles without -- with as minimum economic burden as possible. We are seeing the benefits of those focus points. And I do expect during the year that we'll continue to see good expansion in duration of therapy and get the majority of our -- certainly patients who are in the acute phase of the disease, the majority of those patients, I think this year are going to get to 3 and more cycles. We also, this year, though, are expanding, really focusing on patients who are in the non-acute phase. They, of course, also benefit from long-term therapy and getting 3 or more cycles, but that's probably going to be a little bit longer climb to get there. So I think as we look at the data throughout the year, we've got great patient expansion opportunities by leveraging our strength in acute patients, moving to non-acute. Those acute patients, I think the initiatives are underway and having results that will get us out to those on average, 3 or more cycles. And then the non-acute patients will start to pick up and add certainly good volume growth throughout the year. So I think that's -- we're quite excited about the opportunities with VYVGART this year, the opportunities to get to many more patients and for them to get the full benefits of the drug through persistence and duration.

Operator

[Operator Instructions] Our next question comes from Anupam Rama from JPMorgan.

Anupam Rama

On the global second, third-line DLL3 study, which is enrolling patients, you kind of talked about this, but can you remind us what the ultimate regional breakdown of sites is going to be given this is a global effort? And is there a breakdown of patients that need to be ex China, for U.S. and more global approvals?

Joshua Smiley

Thanks, Anupam. I'll start, but Rafael can talk about the enrollment and how we're thinking about that. But I think first, if we look at small cell lung cancer and focus first on the U.S., I think in the second-line and later settings, we see about 15,000 patients available. First-line is probably 25,000. If we sort of look at that on a major market, Western market sort of look, that's probably 100,000 patients total in small cell lung cancer that are eligible for treatment in first or later-line settings. So it's a big opportunity. And of course, when we sort of size that and you guys have done this as well, it's approaching $10 billion probably in terms of total opportunity, and we think zoci can fit really well in that space. I think when we look at neuroendocrine, we're probably in the U.S., it's somewhere in that [ 5,000 to 10,000 ] sort of range, maybe similarly in other markets. We have more to learn here, I think, as we continue to work through the trial. But it's not insignificant, I guess, is what I would say. Rafael, maybe you can talk about enrollment.

Rafael Amado

Sure. The distribution, I think, of the countries and patients coming from China and other regions is really designed to make sure that we have enough patients post-tarlatamab that reflect real-world usage in the United States. That may be up to 30% of patients or so coming from the United States. About 30% of patients will come from China. This is a reasonable number. I don't think it's ever been questioned that a percent of patients of that magnitude can jeopardize approval in a positive study. The rest of the patients will come from Europe. in terms of post-tarlatamab patients, obviously, we count on Japan as well. We count on the U.K., some countries where a lot of studies have been done with tarlatamab. And obviously, the United States where tarlatamab is gaining market share. So I think that's probably the distribution that you should expect on the study.

Operator

[Operator Instructions] Our next question comes from the line of Cui Cui of Jefferies.

Cui Cui

So I have 3 questions for the management team. The first one is as a follow-up to the JPMorgan question. So could you please share some more details on zoci? So because for this time, we are also very excited to see the clinical trial design for the first-line small cell lung cancer, including the [ combo regimen ] and also for the strategy of NEC. Will it also be advanced to the first-line treatment in the future? And my second question is regarding the KarXT. So what should we expect from KarXT in 2026 and 2027? And how will you build your commercialization team going onward? And my last question is also -- because for the past 1 year, we also saw some deals regarding the autoimmune bispecific. So can we talk about some [Technical Difficulty]...

Joshua Smiley

Thanks, Cui Cui. Rafael, why don't you start and then I'll come back in with the next 2.

Rafael Amado

Yes. Maybe I'll focus on the first-line opportunity. I mean just the overarching sort of desire for zoci to be the centerpiece ADC for different lines of therapies and combinations. And that is because of its low incidence of grade 3 toxicity, activity in the brain and high response rate really and durability. So on first-line, we've seen in the first study, the Phase I/II study 001, we've been enrolling patients in first-line for some time. We started with a doublet with atezolizumab and then a triplet adding carboplatin. And we hope to present mature data towards the second half of this year. We have -- just to give you a sense, we've treated about 60 patients or so, and we continue to follow these patients. I think once we have an idea of the activity, we will then make a decision of what the design of the frontline study should be. Our desire is for it to be one that spares chemotherapy. But also, we have our eyes on how the frontline set of landscape is going to change with the entrance of IMDELLTRA potentially in frontline and other TCEs in frontline. And if we continue to see this high level of activity, we will be testing with other agents as well to see whether this combination offers even more activity for patients in first-line. So I think stay tuned to the data, but our final design will be when we actually see the entire durability and activity in first-line with the data that we've been able to elicit from the Phase I/II study.

Joshua Smiley

Thanks, Rafael. I'll talk about KarXT for a minute. Cui Cui, we're really excited about this opportunity, was approved without only -- product approved without a black box in this setting, first new mechanism in more than 70 years. So there's a really exciting introduction here. We'll launch the product commercially in the second quarter. So we're going through all the process now of getting product in and labeled and inspected and otherwise. So second quarter, we'll be out with the product in the market. Of course, we don't have NRDL listing this year, just given the timing, but we do expect that in 2027. So this year's focus will be on getting physicians' experience using the drug, getting a commercial team up and running. I think prescribing here is really concentrated in China. So while there were, I think, in 2024, over 2 billion days of atypical antipsychotic prescription use. We -- when we look at how that's prescribed and how it's managed, it's probably 800 institutions, give or take, that make up a vast majority of that volume, at least from a sort of initial prescribing and monitoring perspective. So we'll focus on those institutions at launch. That generates something in the range of 100 plus or minus sort of commercial team. So very focused this year, and we'll expand as necessary, but we do see this as a relatively efficient big opportunity. And again, for this year, I think in terms of financials, I wouldn't expect significant sales. Again, this is going to be a non-NRDL product for patients who otherwise aren't going to have things like commercial insurance or other access to payment mechanisms. But for 2027, I think if you look at NRDL and how to think about this, if you look at the branded olanzapine, for example, it's in the range, I think, of about $5 a day on NRDL, paliperidone, similar. So there's, I think, a pretty straightforward reference here. Final comment I'll make on KarXT is I do think this is a relatively straightforward opportunity. Atypical antipsychotics are monotherapy, is like 90-plus percent of the standard of care today. This is a drug that brings great additional benefits in terms of safety and negative symptoms, and we'll be educating physicians on those points this year in preparation for what I think will be an exciting unlock in terms of financial value beginning in 2027. On business development, we've got Shan on the phone and Rafael, we're spending a lot of time around the world looking at opportunities. But certainly, as you mentioned, I think if you look at the innovation happening in China, particularly in areas that we're interested in oncology and immunology modalities like ADCs and T-cell engagers, there's a lot of good opportunities to pick from, and you should expect us to continue to do that. We announced recently a deal on the MUC17, which I mentioned earlier. And I think that's kind of our typical kind of deals you should think about from us would be late preclinical targets that are -- have some biological precedence and where we can move fast, leverage the clinical development expertise that Rafael talked about earlier and have a chance to introduce first and best-in-class products in oncology and immunology to the world, and we're really excited about that.

Operator

We will now take the last question from Linhai Zhao from Goldman Sachs.

Linhai Zhao

My question is around zoci. The first one is regarding the Phase III trial for the second-line small cell lung cancer. Understood that the current clinical protocol does not take tarlatamab as a control arm, but it was allowed to be available both as a prior treatment option and the post-progression treatment options. So on that end, I want to collect your thoughts on the potential risk of having an elongated OS for the control arm given that you're allowing tarlatamab both before and after the second-line treatment? That's the first question. And the second question is about first-line. Understood that you're going to share the Phase I trial data for both doublet and triplet in the second half. And just want to collect your detailed plans about when do you want to make a decision on what to choose from doublet versus triplet in first-line?

Joshua Smiley

Go ahead, Rafael.

Rafael Amado

Thanks for the question. Maybe let's start from the second one. In terms of first-line, we would like to start the first-line study, Phase III study this year. So in spite of the fact that it may take some time for us to see durability, we may just use a landmark in terms of patients without progression at a given number of months and then make a decision. And again, our strong desire is to spare chemotherapy because that's really what leads to most of the morbidity. And most patients can only get about 4 cycles of carbo/etoposide and a checkpoint inhibitor because they progress, actually, the majority of them, some of them are intolerant. So if we're able to give more therapy with ZL-1310 plus a checkpoint inhibitor with the kinds of responses that we see in second-line, we should be better in first-line, and we think we stand a good chance of actually having a positive trial. So that's for first-line. I expect that we will launch a study by the end of the year. And then with regards to your question about tarlatamab, I mean, the patients will be post-tarlatamab in both arms, but they can only come in if they have progressed on tarlatamab. So they -- some may have responded and progressed, some may have been de novo resistant patients, but they will be equally in each arm and the study is stratified for post-tarlatamab versus no tarlatamab. So in that regard, I think each arm will perform equally. With regards to post-progression therapies, the same things apply. We obviously cannot control post-progression therapy. Some patients may get tarlatamab, some may get lurbi, some may get something else. But they should, because it's a sufficiently large study, get those therapies equally in each arm. So whatever advantage tarlatamab may afford in terms of survival, it should be the same in each one of the arms. So we're not really concerned about bias here, particularly in the post-tarlatamab patients that entered the study because they're stratified, and again, they can only come in if they have progressed. So I hope this answers your question.

Linhai Zhao

Just to quickly clarify that you're saying that you're not really concerned about bias between the 2 arms. Can you share a bit more because I would say if the patients use zoci in the second-line, would the physicians still wish to use tarlatamab after zoci?

Rafael Amado

The physician may use tarlatamab after zoci, but so could they after topotecan, for instance, or lurbinectedin. So I guess what I was saying is that tarlatamab is a post-progression therapy, which, again, in survival studies, in any study, we cannot control, but they should be used equally frequently in both arms, because once they progress, it's up to the investigator to decide what therapy to use.

Operator

We have come to the end of the question-and-answer session. With that, I would like to hand the call back to Samantha Du for closing remarks.

Ying Du

Thank you, operator. Thanks, everyone, for taking the time to join us on the call. We appreciate all your support and look forward to updating you again after the first quarter of 2026. Operator, you may now disconnect this call.

Operator

Thank you. That concludes today's conference call. Thank you all for participating. You may now disconnect your lines.

Investor releaseQuarter not tagged2026-02-10

Zai Lab to Announce Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Updates on February 26, 2026

Business Wire

- Company to host conference call and webcast on February 26, 2026, at 8:00 a.m. ET (9:00 p.m. HKT) SHANGHAI & CAMBRIDGE, Mass., February 10, 2026--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will report its fourth quarter and full year 2025 financial results and provide recent corporate updates on February 26, 2026, before the opening of U.S. equity markets. The announcement will be followed by a conference call and webcast at 8:00 a.m. ET (9:00 p.m. HKT). Conference Call and Webcast Information The live webcast can be accessed by visiting the Company's website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details are as follows: Registration link for webcast (preferred): https://edge.media-server.com/mmc/p/ftt8dzjp Registration link for dial-in: https://register-conf.media-server.com/register/BI3888301d591947ae8d0ccb041164c8e6 All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering. A replay will be available shortly after the call and can be accessed by visiting the Company's website. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.X.com/ZaiLab_Global. View source version on businesswire.com: https://www.businesswire.com/news/home/20260210221858/en/ Contacts For more information, please contact: Investor Relations: Christine Chiou / Cyan Liu +1 (917) 886-6929 / +86 195 3130 8895 [email protected] / [email protected] Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015 5011 [email protected] / [email protected]

Investor releaseQuarter not tagged2025-11-07

Zai Lab Ltd (ZLAB) Q3 2025 Earnings Call Highlights: Strong Revenue Growth Amid Market Challenges

GuruFocus.com

This article first appeared on GuruFocus. Release Date: November 06, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Zai Lab Ltd (NASDAQ:ZLAB) reported a 14% year-over-year revenue growth, reaching $116 million in Q3 2025. The company is on track for its first global approval of ZL 1,310 (Zozi) by 2027 or early 2028, with promising data in small cell lung cancer. Zai Lab Ltd (NASDAQ:ZLAB) has a commercially profitable business in China, with a strong commercial team and differentiated high-potential assets. The company is advancing its global pipeline rapidly, with several innovative programs in oncology and immunology. Zai Lab Ltd (NASDAQ:ZLAB) maintains a strong financial foundation, ending the quarter with $817 million in cash, providing flexibility for future investments. The pace of market build for Vivguard in China has been slower than initially anticipated, affecting revenue expectations. Zai Lab Ltd (NASDAQ:ZLAB) revised its full-year revenue guidance to at least $460 million, reflecting slower growth in some areas. The company faces supply constraints for certain products, impacting its ability to meet demand fully. Despite being commercially profitable in China, the overall pace of growth has been slower due to a complex and dynamic environment. Zai Lab Ltd (NASDAQ:ZLAB) expects profitability to shift beyond the fourth quarter, reflecting a lower revenue base this year. Warning! GuruFocus has detected 7 Warning Signs with ZLAB. Is ZLAB fairly valued? Test your thesis with our free DCF calculator. Q: How should we be thinking about the key drivers for growth and the path to profitability given the revised revenue guidance? A: Josh Smiley, President and COO, explained that revenue growth will continue to be driven by Vivguard, with expectations of continued sequential growth due to new patient additions and increased treatment duration. They anticipate growth in Zajula as well, despite some competitive dynamics. The path to profitability will be driven by growth in the China business, which is already profitable, and continued top-line growth to cover R&D and corporate costs. Q: Can you set expectations for the initial data readout for ZL 1,503 expected in 2026, and how do you see the opportunity in atopic dermatitis? A: Dr. Rafael Amato, President and Head of Global R&D, expressed excitement...

As of 2026-05-18 • Updated weeklySource: Earnings sourceIngestion runbook