Q3 2025 Zai Lab Ltd Earnings Call

Hello, ladies and gentlemen, thank you for standing by and welcome to zylabs, third quarter 2025 Financial results conference call.

At this time, all participants are in a listen-only mode. Later, we will conduct the question and answer session.

And instructions will follow at the time. As a reminder, today's call is being recorded.

It is now my pleasure to turn the floor, over to Christine Joe, senior vice president of investor relations. Please go ahead.

Thank you, operator. Hello and welcome everyone. Today's earnings call will be led by Dr. Samantha do silabs, founder CEO and chairperson. She'll be joined by Josh, Smiley president and Chief Operating Officer Dr. Rafael Amato president and head of global research and development and Dr. Yajing Chen Chief Financial Officer.

As a reminder during today's call, we'll 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 also refer to adjusted loss from operations, which is a non-gaap financial measure.

Please refer to our earnings release, furnace with the SEC on November 6th 2025 for additional information on this non-gaap financial measure.

At this time, it is my pleasure to turn the call over to Dr. Samantha do.

Thank you, Christine.

Good morning and good evening, everyone.

Thank you for joining us today.

Before we discuss the quarter, I want to take a moment.

To reflect on who we are, where we're headed.

That life was built on a clear region.

To bring the best Global Innovation to patients in China.

And to discover and develop new innovations that can compete on the world stage.

That Vision remains unchanged.

Today, our Global pipeline is studying to the Forefront.

Becoming the next key chapter in size growth story.

Josie. Oh TL 1310 has now entered the pivotal stage.

I spent 2 years from Phase 1, 190

The extraordinary Pace, but any standard in our industry?

And we're on the path for our first Global approval by 2027 or early 2028.

Beyond toi. We're expanding our Global portfolio with other highly differentiated programs.

Our l13 L 31 best specific, the topic demo Titus.

Our 12.

TV1, best specific and lrc 15 ADC, for solid tumors.

more importantly, we have built a global R&D organization that combines speed scientific rigor

and quality expected of a global B farmer.

On our Commercial Business in China.

We are commercially profitable today.

And on the study profitable growth path.

However,

Pace has been slower than expected.

The environment is complex and dynamic.

But at the same time, there are encouraging signs of progress.

Regulatory reveals a faster.

And ennard negotiations are more transparent.

We have 1 of the strongest commercial teams in the industry.

Backed by a portfolio of differentiated high potential assets.

And we remain confident in the long-term potential of this business.

This next chapter will take focus and persistence.

But we have the right signs, the right team, and the right vision.

Together. We're building a company that will make a lasting difference for patients and create long-term value for our shareholders.

With that, I'll now hand the call over to our field.

Who will walk you through the progress of our R&D pipeline Rafael.

Thank you so much. I will begin with a few highlights from our Global pipeline, starting with ZL 1310 or zozi

2 weeks ago at the triple meeting conference. We presented updated Phase 1 data and previously treated its expenses. Stay small till lung cancer.

This Global study enrolled 115, patients across the US, Europe and China.

A baseline 90% of patients had received a TV1 or pdl1 therapy. Nearly 1, sir, had bring the dusty and several hot progress on a prior deal of 3 targeted therapy including tarat. Making this a very difficult to treat heavily pre-treated patient population.

At the 1.6 milligrams per kilogram dose. We observe an overall response rate of 68% and a Disease Control rate of 94% among the strongest. Efficacy signals reported in the second line setting.

Importantly, we also saw robust activity in patients with brain metastases including an 80% overall response rate in lesions which had received no prior treatment of any kind suggesting that zozi may offer a new way to control both systemic, as well as intracranial disease without interrupting therapy. A potential Game Changer in terms of speed to treatment for these patients whose tumors tend to be growing very fast.

Across all Doses and lines. The median duration of response was 6.1 months and the median progression. Free survival was 5.4 months, which is highly encouraging for a monotherapy in this refractory population, across Doses, and lines of therapy.

Data from the 1.2 and 1.6 milligrams per kilogram cohort, continue to mature as enrollment continues and patients remain on treatment.

Joe also continues to demonstrate a best-in-class safety profile at the 1.6 milligrams per kilogram dose grade 3 or higher treatment related, Adverse Events were observed in. Only 13% of patients far below the 35 to 50% rate. Seen with other adcs in this setting,

There were no drug-related discontinuous or debts and only 2 grade 1 interstitial land disease cases across both expansion doses of 1.2 and 1.6 milligrams per kilogram.

This combination of deep efficacy and favorable tolerability positions Z as an ideal candidate for the first line combinations where safety is Paramount.

With and without chemotherapy, in addition, we see significant opportunity for zi as a backbone therapy in Noble mechanism combinations. We plan to initiate studies with agents with orthogonal and complimentary mechanisms of action and we will share details. Once the studies are posted on clinical draw,

Beyond small cell. Lung cancer. Justice is being evaluated in neuroendocrine carcinomas or ACS which have poor prognosis and no targeted therapy despite High dll3 expressions.

Early data with ZL, 1310 are encouraging and we plan to present results in the first half of next year, and to move into a registration of study thereafter.

Beyond our next wave of innovative, Global assets. Continue to advance rapidly.

CL 1603 are internally discovered IO 13 IO 31 by specific antibody for a topic dermatitis. Recently, entered Phase 1, its dual mechanism targets, both each and inflammation and its extended Half-Life offers potential for Less frequent dosing. It's up to 10 formulation as being developed.

For clinical results supports its use in other inflammatory diseases. First in human data are expected in 2026.

CL 6201 is an internally discovered lrrc15 targeted antibody with an Next Generation payload Linker. It remains on track for a Us in this submission by year end and a global Phase 1, Study initiation early next year for patients with cancer that has tumor cell or tumor stomach expressing this target.

CL 1222 is another internally discover asset. It is an Next Generation pd1. Il124

Now, turning to our key, lay stage, Regional programs in immunology and Neuroscience.

A cartisian map continues to expand across multiple or immune indications. The adapt serum study insert negative GMG was positive. The first Global safety trial to show clinically meaningful improvements across all 3 GMG subies MK Plus lrp for plus and triple Sarah negative.

3 additional phase 3. Read out an ocular MD mayasiz and thyroid, idc's are expected next year with China contributing to Global enrollment.

For poaces help. Our partner vertex, recently received FDA brexit therapy designation for an

enrollment of the global raineer phase. 3 is complete with an interim analysis plan, for the first half of 2026 where patients are China are included and potentially supporting and accelerated, approval submission next year.

The global pivotal Phase 23, study in primary member of nephropathy was initiated in October, and we're on track to enroll patients in China, this quarter.

Together this achievements, reflect the depth and quality of our pipeline 1. That is advancing with speed and efficiency and with a clear focus on novel, mechanisms and clinical differentiation.

In summary over the next 12 months, we expect to reach several important Milestones across our Global portfolio.

For soie, we expect a catalyst Rich here with updated in the cranial data, first line, small cell, lung, cancer combination data, and resulting in neuroendocrine carcinoma in the first half. In parallel, we plan to initiate registration of studies. And first lines was a lung cancer and other neuroendocrine carcinomas as well as starting price with Noble combinations across line of therapy.

Beyonce. We expect first in human data, for ZL1 1503 or is 1331 and to advance, ZL6, 201 or lrc 15 into Global Phase 1 development.

We're also progressing in ZL1 222 or as ipv1 is 12 Agonist I look forward to sharing additional data in the coming year.

And with that, I'll hand it over to Josh.

Thank you. Raphael and hello everyone before we turn to our third quarter results at like to start by welcoming Dr. Shan he as our new Chief business office.

Champs brings both deep scientific expertise and investment experience and we'll play a central role. In expanding our portfolio, and unlocking value through Partnerships and out licensing.

Helping build the strong foundation and now supports our next phase of growth.

now, turning to our commercial performance,

Total revenues were 116. Million representing 14% growth year-over-year.

To 27.7 million which includes a 2.4 million reduction, following a voluntary price adjustment on high trullo to align with ennard guidelines ahead of national pricing negotiations.

While this adjustment affected reported sales, the underlying fundamentals of the launch remain very strong.

Vivart continues to be 1 of the most successful Immunology, launches, ever in China. Ranking as the number 1 Innovative drug by sales, among all new launches in the past 2 years,

more importantly, the trends beneath the headline numbers point to durable long-term growth.

There are 2 key Drive, growth drivers, underpinning, the trajectory of Viv guard and GMG patient demand and treatment duration, the latter of which is particularly important, given the chronic nature of the disease.

First on demand, we continue to see steady new patient editions each month with nearly 21,000 patients, treated a date.

They've got penetration in GMG remains only around 12%. Meaning we are still in the early stages of Market development with significant room for expansion,

second on treatment duration, the updated mg guidelines published in July have been a meaningful catalyst

To emphasize both the importance of Rapid symptom control, where vivu demonstrated strong efficacy, and a minimum of 3 treatment Cycles to reduce the risk of relapse and maintain durable, Disease Control.

Since publication, we've seen clear signs of positive impact in real world practice.

Physicians are becoming receptive to maintaining patients on therapy. Even after achieving symptom control signaling, a shift from episodic to maintenance use.

as a result of our efforts, the average files per patient have increased over 30% year to date year to date versus last year with a notable acceleration in Q3

in vivart volumes have grown sequentially in the mid-. Teens

We see this level of growth as realistic and sustainable as we head into 2026.

Now admittedly the pace of Market build for this first and last therapy for chronic disease, has been more measured than we initially anticipated.

With vyvgart.

Through physician education and Real World experience. We aim to change long-standing treatment patterns.

While the ramp is slower than expected, the long-term potential of vyvgart.

GMG, we're making progress in cidp, expanding access across both supplemental and Commercial health insurance plans.

We will continue to add new layers of growth with new indications and formulations with the most immediate being Cerro negative GMG and the pre-filled syringe.

Looking ahead. Our next major launch opportunity is karxt currently under regulatory review.

Karxt has the potential to redefine schizophrenia treatment in China. Introducing the First new mechanism of action in more than 70 years.

Notably, it has already been included in the China. Schizophrenia prevention and treatment guidelines 2025 Edition.

the first national guideline globally to do so underscoring, its strong differentiation and anticipated, clinical impact

Across the company, we remain disciplined in our operations scaling efficiently, while investing strategically in commercial execution, in pipeline innovation.

And with that, I will now pass the call over to ya Jing to take us through our financial results judging.

Thank you, Josh.

Now, I will review highlights from our third quarter, 2025 Financial results compared to the prior period.

Total revenue grew 14% year-over-year to 160 million dollars in the third quarter.

primarily driven by higher sales of new Zyra supported by increasing Market coverage and penetration,

Demand for that. Duro remains robust and we aim to normalize Supply by year end.

The July grew sequentially, but declined year-over-year, and made evolving competitive Dynamics within the pop class.

Given this trend as well as Vivid art Dynamics discussed earlier.

We are updating our 4 year, total revenue guidance to at least 460 million dollars.

The percentage of Revenue declining significantly year-over-year.

On the expenses for the third quarter, decreased 27% year-over-year.

To decrease in licensing, fees in connection with upfront and Milestone payments.

188 expenses for the third quarter increased 4% year-over-year, many due to higher general and selling expenses to support the growth of new Zyra and the Visa card, partially offset by lower selling expenses for the jeweler.

As a result lock from operations. Improved 28% in the third, quarter to 48.8 million

And the adjusted loss from operations, which excludes certain non-cash items.

Depreciation and share based compensation.

Was 28 million dollars in the third quarter, a 42% improvement from the prior year.

While we expect meaning for quarter over, quarter Improvement in adjusted operating loss.

We now expect profitability to shift beyond the fourth quarter.

Reflecting the lower Revenue based this year.

Importantly, our fundamentals remain strong.

Our China business is already commercially profitable and growing and we are executing strong, financial discipline and investing strategically in R&D.

We are on a path to profitability and I will provide updated 2,726 Financial guidance. When we report our 4 year 2025 earnings,

Zap is at a major value inflection point.

With a rapidly advancing Global pipeline a commercially profitable, China business and a path to profit profitability.

We also maintain a strong financial foundation and in the quarter with 817 million dollars in cash.

Which provide?

Invest.

In both in.

Innovation.

And with that, I would now like to turn the call back over to the operator, to open up the line for questions.

Operator.

Thank you.

We will now begin the question and answer session.

To ask a question, please press *1, 1 on your telephone and wait for your name to be announced to redial your question. Please press *1, 1 again.

Please limit to 2 questions at a time. If you have follow-up questions, please request to rejoin.

Please stand by while we compare the Q&A roster.

We will now take our first question from the line of Jonathan Chang from lorinc Partners. Please go ahead.

Hi guys, thanks for taking the questions and best wishes to Jonathan Wong.

Um, first question on the revised Revenue guidance, how should you be thinking about the key drivers for growth and the path to profitability?

And then second question on zetal, 1503.

Can you help set expectations for the initial data readout?

Expected in 2026. And how are you guys seeing the opportunity in a topic dermatitis? Thank you.

Uh thanks Jonathan. Hey it's Josh Smiley uh good morning everybody. Um any good evening, uh, thanks for the questions. I'll I'll take the first 1 on Revenue. Uh, drivers. And then Raphael will talk about 1503. Uh, I think, as we think about Revenue, uh, headed into the fourth quarter here, uh, drivers will continue to be, uh, Viv guarde, you know, continued good, sequential growth driven by new patient additions and continued um uh, growth and durability or in, in terms of the number of doses patients. Get we are seeing. As I mentioned, in the opening remarks, we're seeing good progress. Uh, as a result of the national guidelines that were issued in July, which focus on getting patients, uh, into at least 3 courses of therapy. So, we'll, we'll see, we expect to see continued growth there, a Zula. Uh, you know, we are seeing a return to growth, you know, as we've mentioned throughout the year, the quarterly numbers, I think will be a little bit choppy because of the generic, um, uh,

Will face Supply constraints. So, uh, we'll be, you know, somewhat limited as we come into the fourth quarter here there, but overall, uh good momentum in the portfolio and good growth drivers uh, will give uh more specific guidance for 2026 as as we get into next, um, next year. But obviously, we're looking forward to the launch of karxt. The potential, uh, approval of tivdak, and, you know, continued growth in these, uh, in the core part of the portfolio. Um, uh, as it relates to profitability, again, our profitability will be driven by uh, growth in the business in China. It the the China business of course, is profitable today and as we continue to drive um, Topline growth that profitability will be enough to cover the R&D and corporate, uh, costs that we have. So, you know, we're still on that path. It's just, uh, we just need the growth to continue in the portfolio with that. I'll, I'll turn it to Rafael to talk about 1503.

Thanks, Josh, and thanks Jonathan. So 1503, we're really excited about this molecule. Uh, as you know, is uh, both dual IO, 1331 Inhibitors, um, you know, drop File 13 and, um, we know that that is a true and pathway and 31 is a very potent, uh, pathway in initiating providers. So, uh, within the combination plus, uh, the long Half-Life is is going to, uh, translate into a really brisk effect, which is very fast and

Sustain, um, we have uh, initiated the IMD already, we plan to uh, do a multi-country study um, and obviously it's a first in human study. We will do single ascending dose in normal volunteers, and then multiple doses in patients with atopic dermatitis. Um, in the lab we've been looking at other models of th2 diseases. And, um, we are very encouraged with what we're seeing on asthma or nitus and, and other, uh, disorders, uh, uh, that affect, uh, uh, T, helper 2. Um, so, uh, in addition to this, we're going to be looking at efficacy endpoints, given the half-life that is long. We think that, uh, we will be able to see effects on easy scores as well as ID. And so this is going to be measure uh very frequently. Uh, we hope to have the data available by the middle of next year, um but it will obviously accumulate

Uh, throughout next year, and we will present when we have, uh, sufficient sufficient data. Um, it's a placebo control trial. So, um, uh, we'll be able to have comparisons and, and obviously we know what, uh, the landmarks are here with other products. Um, so, uh, again a very large opportunity, this is a very common disease, even a fraction percentage of capturing, uh, in ad would be a large opportunity and also

So, uh, the possibility of expanding into other gh2 diseases that we make this a very promising product.

Thank you.

We will now take our next question from the line of anupam Rama from JP Morgan. Please go ahead.

Hi. This is Jory phone for aom. Thanks for taking your question, the press release today. Really LED with progress on your own, internal Global development programs is this a shift in higher thinking about the resource allocation in terms of your prior focus on external? BD versus now the internal pipeline. Thanks so much.

Thanks, it's, it's Josh. I'll start. Um, but first we we, we are very excited about the pipeline that we have today with the global emphasis. And of course, that will be a priority to invest in and Raphael outlined, uh, you know, our near-term focus in terms of um, 1310 and uh, getting the registration trial up and running and and expanding into the first line and into neuroendocrine tumors. So that's going to be a focus. Uh, we've got a really exciting Global portfolio behind that. Um, we think we have the capacity here to fully invest in those programs. Uh, we have a strong balance sheet with, with, uh, plenty of cash to continue to pursue on a targeted basis. The right kind of external opportunities to bring in both on a global and

Profitable over time.

Thank you.

We will now take our next question from the line of ego novix from CT. Please go ahead ego.

Hi. This is Caroline on for your goal. Thanks for taking your question. We were wondering where you're seeing the greatest opportunity and greatest likelihood for success for your internal Global pipeline among lrrc and pd1 is 2 and others. Uh, the second question is okay, um,

Raphael jump in. On this 1, please.

Sure, um, obviously the the most immediate 1 is 1310. Uh, I mean it clearly is quite active. Uh It is Well tolerated. Uh, very few, uh, related grade 3 and above uh uh, 3 minute effects, uh, 3 minutes side effects, um, a strong brisk effect on brain. Metastasis is even untreated brain metastases and again, very high percent of patients responding. Um, we are starting up the the face, uh, 3 study for second line. Uh, we've had recent discussions with FDA and we're sharpening, the, uh, the design, uh, to the point that, uh, it's already started. Um, we, uh, we will continue to do some work on the dose, but I think, uh, that is, you know, going to finish.

Pretty quickly, uh, with regards to the rest of the products, obviously 1503. I mean, these are proven Pathways. So, uh, you know, the bar for activity is pretty low. Uh, and also, the characteristics of the product, uh, with FC modification for long Half-Life, makes it, uh, very ideal for patients with this, chronic diseases. Um, and then, with regards to, uh, some of the other ones lrc 15 is, is particularly interesting because it would be the first time where, um, a tumor is being targeted where the target is not necessarily in the tumor. So, um, there will be these 2 groups of patients. Uh, like seroma patients where, uh, the 2 more that's expressed lrc 15 but others in which, uh, the tumor, uh, only expresses the Target in fibroblasts. And if that is the case, if we can actually abrogate tumors, uh, where the tumor is negative, that the tumor and

Like environment is positive. Then it opens, uh, a whole host of tumor types. Uh, so pretty excited about this. And I think, uh, we are, you know, we saw this leading in ADC, which is 1 of our, uh, focusing in, in, in oncology and then I'll finish with a p p. 1 is 12. It's been very hard to Target io2 because it's toxic. So we've, uh, been able to engineer an aisle 12, uh stimulated uh, muy which actually

It's attenuated. So it doesn't really cause side effects of T Cell Activation. And at the same time, uh, with full block gate of pd1. So in animal models, we can see that we can actually restore pd1 resistant tumors uh which would be uh uh, pretty exciting to see. Um, and we have seen as, you know, more uh, enhancements on pd1 uh as a checkpoint uh with other molecules and within that other than I 12 would be would be 1 of them. Um so um um I'll just finish by saying that we can move these things. Uh pretty quickly. We'll have 2 in this this year 1 of them will enroll this year. The other 1 will start enrolling in in January and 31 l 12 uh is a candidate that will have an IND next year and hopefully the first patient as well in the second half. So um, yeah, we're excited about all of them. But obviously, our, our our strongest Focus right now is

making sure that we capitalize on 13%.

and on my second question,

uh we're wondering what you're doing to set yourself up for a strong car, XT launch. And what more have you learned about the schizophrenia Market in China to best position car XT in the marketplace? Thanks.

Legacy on positive symptoms, negative symptoms in cognition is, is I think um well, anticipated and and and uh, thought leaders are anxious for this drug to come. So we'll launch, um, with a targeted sales force. The I think the difference in China versus what we see in some of the western markets, certainly in the US is it's a more concentrated approach uh, patients tend to be in bigger institutions. So with a relatively targeted, sales force and education, uh, program, we should be able to touch a significant portion of the market, um, at launch. And again, just to remind, uh, you know, people that the, the opportunity here is is, um, you know, is quite quite significant with millions of patients today, um, suffering from schizophrenia obviously, it's a life lifelong disease. So, uh, we're anxious to get the approval first to get up and running in 2026 and then move toward uh, ennard listing in 2027.

Thank you.

Our next question comes from the line of Lee. Walk from Canto fix Gerald. Please go ahead.

Uh, hey, good morning guys. Thanks for taking our questions. I have 1 commercial 1 pipeline question. Um, I guess just given some of the complex commercial Dynamics in in China and your revised guidance. Can you provide your updated views on the 2 billion dollar Revenue Target by 2028?

Um and then second is for those sea. Sounds like you're expending to new endocrine tumors next year. Uh, I wonder if you can just, you know, talk a little bit about the pathway to approval and what would be the bar?

Thanks Lee. It's it's Josh. I think, first on the 2 billion dollar 2028, uh, goal. Uh, you know, we will look at all the, the moves that we've had in the portfolio and we'll provide a, a more wholesome update, uh, you know, next next year, you know, maybe starting at JP Morgan, but but to comment we feel really good about the portfolio. We have today, as Samantha mentioned up front, I think the most exciting piece is the opportunity for um, sales outside of China. In 2028, we mentioned that 1310. We see a path for an approval as early as late 2027. Um, so to have, you know, some significant sales in 2028 coming from the US in small cell lung, cancers, I think quite exciting and and you know certainly represents a new uh, inflection point in phase of growth for us the portfolio, in China continues to grow and uh you know, we've talked about the Dynamics with with vivart, which we continue, we expect, you know, over the course of the next number of years to continue to grow at a

Good and steady rate, uh, supplemented by additional indications, you know, since we, uh, have talked about that Revenue goal, we've added a POV and I both of, which can, uh, launched in the, in the 2028 time frame. So we're we're quite excited about the long-term growth potential of portfolio and most excited this year about the progress on 1310 and what it means for sales, not just in China, but outside of China within this time frame

Yes. So you can. Yeah, jump in please. Yeah, thanks Caroline. So I'll talk a bit about uh NEC so the study that we have has uh 2 cohorts of carcinoma. So these are highly proliferative tumors that have a poor prognosis 1. Our gastroenteropancreatic tumors or GBS and the others are other necessities that can arise from from other sites, uh, or other organs. Um, we are seeing responses in both groups, um, it's still early days obviously, uh, and we're accumulating more and more, uh, evidence of activity. These are patients that have had more than 1 line of therapy, which tends to be platinum. Uh, base therapy, uh, and there really isn't any standard for these patients, um, uh, the tumors tend to grow fast and and actually, the mortality is quite High. Um, so, in terms of, uh, how we want to proceed with this, um, the

With this kind of results, could result in an accelerated approval. The alternative is to do a physician Choice compared to, uh, which uh, also we would be prepared to launch. Uh, and, you know, given the activity that we are seeing if it continues, uh, it wouldn't be a very large study, particularly given the, the large Amendment need. Uh, and, and, and the fact that this is an orphan indication. So a pretty excited about what the agency will see, uh, and and find Once, uh, we have, uh, sufficient follow-up and sufficient patience, uh, to characterize the activity.

Thank you, as a reminder, before we take our next, it is star. 1 1 1 on your telephone keypad, if you wish to ask a question,

Our next question comes from the line of from from Sac, please go ahead.

Uh, thank you for, uh, taking my questions. Uh, can you hear me?

Yes.

Oh, great. Uh, thank you Josh, um, 2 questions. Um, the first 1 is uh, regarding the guidance. Uh, we try to understand a bit more about, you know, compared to the expectations set in any guidance previously in which areas as a company encountered deeper than and anticipated challenges. You know in China environments um particularly for you know, gift card and the Julia

Um, um, could you elaborate a bit more and also um, you know, I think beginning of the year in uh, in terms of the guidance. Um, not only about the Topline. But also you mentioned about uh, first quarter, cash Break, Even Target, uh, is that still intact? Uh, that's my first 1. Second is regarding the R&D because, um, on zap is really pivoting, you know, towards a global, uh, R&D company. So in terms of the pipeline build up, particularly for the early stage pipeline, build up. Um, now we got oncology, you know, adcs we have um, 2 different adc's, we have P1 L2. And we also have imin so um we try to understand a bit more about uh, the strategy. The portfolio strategy. You know, when you deciding um what to go after and I want what not to do so um could you providing a bit more color on that? Thank you.

Sure, thanks Steve. Uh, um, first on the, the performance this year, I would say relative to our initial expectations, uh vyvgart to get uh to the, you know, the rate that we of of treatment that we see in the, the US market, for example. So we're focused now on getting patients up to, at least, you know, 3 cycles of treatment. And we're seeing progress there, it's just slow. So I would say that's our

Um, you know, sort of, uh, on the vivart piece. That's the piece that has been the the slowest relative to our expectations. Again, I think this is uh, what we're realizing is, it's a long-term build the market opportunity. We have the long term with this product and we're seeing good response to things like the national guidelines and our, you know, continued um, uh, Promotional and educational efforts. So, uh, just a slower, uh, ramp to get to the kind of um, uh, treatment duration that we see in the uh, in the western markets, um, on uh, on um, Zula. Uh, we, you know, we expect to gain share as a function of Limp para going generic. And we saw some delays there in terms of relative to our initial expectations relative to vbp again. We we expect that to kick in uh beginning in the fourth quarter and set us up well for uh for next year. Uh, you know, certainly again there are dynamics related to affordability and and and Hospital purchasing and otherwise

That may make that a bit, you know, choppy but I think the underlying opportunity for residual is to gain share, uh, you know, from uh, from what had been lump para as it goes to generic the third piece process then just Zack, Doro, we've talked about this through the year. Uh, it's it's a great product and our partner, uh fizer, you know is seeing really good, great response, and demand uh in the hospital setting for this uh for this drug. And we've had more Supply constraints than we anticipated.

Our non-gaap number, you see continued good progress in that regard. Um, and I that, that progress should continue, we'll give you an update for 2026, but really, it's just going to be a function of continued growth on the, on the top line. And I think at the numbers that were suggesting here for, um, you know, for the fourth quarter, we probably won't quite get there. But we'll still, you know, we'll still still show, good Improvement and and we'll be on that path as we head into 2026, uh, Rafael if you can talk about the, you know, how we think about the portfolio and the the next opportunities

Sure. Um, so the portfolio will continue to grow as a blend of both internal as well as external opportunities. I, I'm really proud of the fact that many of the products that are now, uh, in development, uh, came from our protein science, Laboratories, which uh have been very productive. But in terms of strategy in oncology, um, we will continue with, uh, antibody drug conjugates and we will continue to innovate there. There are other antibodies that we haven't mentioned that are in the pipeline at the moment. And, uh, we spend a lot of time, trying to characterize the antibody Visa with the targets, uh, and then use the right payload Linker, so that's going to continue to grow. Um, we also have an interesting

Made an effort, uh, in diesel engagers and, uh, we will, uh, be, uh, reporting with time, you know, some of these candidates and entering the clinic, uh, outside of oncology. Um, you're right, I mean, we have been focusing on our immunity is neuroscience and Immunology. Um, in autoimmunity, we're focusing on Saito, uh, both antibodies, or by specific, um, you know, perhaps cell depletion as well and then signal transaction of some of these Saito Pathways, uh, which involves small molecules as well. Um, and so overall, um, we will remain opportunistic obviously for, uh, either Regional or Global opport opportunities that have novel mechanisms of action and have differentiation and really make a big difference for patients. Uh, but the guard rails, if you will, are the ones that that I just described to you. Um, so thanks for the question.

Yeah, I think, uh, Joey, just like, uh, Rafael was saying.

We, even though our pipeline in China regional pipelines has, uh, oncology, autoimmune, and, uh, neuro, and, uh, you know, and they are under anti-infectives. But for our global pipeline, we are focusing on oncology and autoimmune and, uh, and.

Anti-inflammatory specifically, like to refill things. So, internal internally for Global development pipelines. We are only focused on those 2 areas.

Right. Thank you.

Our last question today comes from the line of Claritin. From Jeffrey's please go ahead, Clara.

Hi, good morning, thanks for taking our questions. This is Jenna on for Clara. Um, we have 2 questions if we met, um, first, um, on this card. Um,

Uh, I think previously, we were under the impression that sales will be back half loaded. Um, so it was just curious what, um, kind of visibility or leading indicators. You may have for Q4 and 2026 and more specifically can you comment on? Um you know, for example Pace um number of Cycles on average patients are getting today. How does the pace look like to over the next few years? To reach the fee 3, average doses. Um,

And then our second question is on bema and in the context um, of the uh, Amgen announcement uh was just curious if it's still possible to have a path forward for just China based on the trials, you're running or the data you have in hand. Thank you so much.

Acute setting, but to get the full benefit for patients with GMG that allows them to work and live their lives fully. You know, you need to get the maintenance benefits which which kick in at at least 3 Cycles through this year, we're seeing progress towards an average of 2 cycles per year. And as you mentioned in your question, the the goal is to get to at least 3 and over time, you know, aspirations toward 5 where we see the full benefits in clinical, trial, and real world setting. Um, so I think as we, we look into next year, we'd expect the underlying growth to continue. Probably at this, you know, what we're seeing in terms of, um, uh, volume, you know. So, it's sort of number of vials in total is sequential quarterly growth in the, you know, sort of low teens. And I think that, that

Uh reasonable to expect as we head into to next year and continue to sort of climb towards that you know, on average uh you know, 3 cycles of um of use uh, Again supplemented by or or accelerated by the national guidelines that that were issued in July and our efforts to educate physicians in that regard. So we're, you know, we're looking forward to the continued underlying growth here. And, uh, I think expect that to continue on a, on a, a good basis as we head into 2026. Um, Rafael, if you want to talk about bema,

Sure. So, uh, we're still digesting the data. You saw the data at asthma that was presented with the primary analysis or 096. And then the final analysis with this attenuated 3 main effect. Um, and then I'm then announced that 098 was, uh, negative study in terms of not meeting, uh, statistical significance. So we're looking at, uh, with with Amgen and our partner at, uh, you know, translational markers and subgroups, uh, and we will be doing this in the upcoming weeks, uh, and make a decision. But, um, you know, our opinion is that it will be very challenging, uh, to get an approval in China with, uh, this data set. Um, so as such, we're thinking about how to deploy these resources to the rich pipeline, that, that we've seen discussing today, uh, and try to, uh, uh, capitalize on the fact that we will have uh, you know, this opportunity of uh time people.

Resources and effort, uh, to advance the current pipeline.

Thank you. We have come to the end of the question and answer session. Thank you all very much for your questions and I'll turn the conference back to Dr. Samantha to for her closing commands.

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 again, after the fourth quarter of 2025.

Operator. You may now disconnect this call.

Thank you for your participation. In today's conference, this does conclude the program. You may now disconnect your lines.