Q2 2025 Zai Lab Ltd Earnings Call

August 7, 2025

Operator: Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's Q2 2025 Financial Results Conference Call. At this time, all participants are in the listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.

Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's second quarter 2025 financial results conference call.

Christine Chiou: 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, ma'am.

Operator: 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, ma'am.

At this time, all participants are in the listen. Only mode later, we will conduct the 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 Cho, senior vice president of investor relations.

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. Jonathan Wang, 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.

Ma'am.

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

Christine Chiou: Please refer to our earnings release furnished with the SEC on 7 August 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 Du.

Jonathan Wong 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 4 looking statements based on our current expectations. These statements are subject to numerous risks in the 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 August 7th, 2025 for additional information on this non-gaap financial measure.

Christine Chiou: Thank you, Christine. Good morning and good evening, everyone. Thank you for joining us today. As we've reached the midpoint of 2025, Zai Lab is entering a pivotal phase, scaling our commercial business, advancing our global pipeline, and executing on the goals we outlined at the beginning of the year. Our long-term vision of becoming a leading global biopharma remains strong, grounded on consistent execution and meaningful progress across the business. We are reaffirming our full year revenue guidance of $560 million to 590 million. We remain on track to achieve profitability in Q4, a milestone made possible by the efficient, scalable model we have built over the years. In our original business, momentum is building as we head into a period of significant growth, supported by multiple near-term launches.

Samantha Du: Thank you, Christine. Good morning and good evening, everyone. Thank you for joining us today. As we've reached the midpoint of 2025, Zai Lab is entering a pivotal phase, scaling our commercial business, advancing our global pipeline, and executing on the goals we outlined at the beginning of the year. Our long-term vision of becoming a leading global biopharma remains strong, grounded on consistent execution and meaningful progress across the business. We are reaffirming our full year revenue guidance of $560 million to 590 million. We remain on track to achieve profitability in Q4, a milestone made possible by the efficient, scalable model we have built over the years. In our original business, momentum is building as we head into a period of significant growth, supported by multiple near-term launches.

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.

as we've reached the midpoint of 2025,

That life is interesting. A pivotal phase?

Filling our Commercial Business, advising our Global Pipeline and executing on the goals. We outlined at the beginning of the year.

Our long-term vision of becoming a leading Global biofarma remains strong.

Grounded on consistent execution, the meaningful progress, the business.

we are reaffirming our full year Revenue, guidance of 56 million, to find 90 million USD,

In Romanian track to achieve profitability in the fourth quarter.

A milestone met possible by the efficient scalable model we have due to over the years.

In our original business.

Christine Chiou: This includes pipeline product opportunities like VYVGART in multiple autoimmune indications and povetacicept, a new BAFF/APRIL inhibitor with broad potential. We also anticipate approvals for KarXT in schizophrenia and TIVDAK in cervical cancer, both currently under regulatory reviews in China. We're preparing for submissions for other later-stage assets, including Vimatus map for gastric cancer and Tumor Treating Fields for pancreatic cancer. Combined with our broader regional pipeline, these programs position us well for long-term growth. On the global R&D front, we're advancing a pipeline of innovative, globally competitive programs. GL1310, our DLL3 ADC, continues to demonstrate best-in-class potential in small cell lung cancer, as illustrated by the updated data presented at ASCO. We also see encouraging early signals in other difficult-to-treat tumors, such as neuroendocrine carcinoma.

Samantha Du: This includes pipeline product opportunities like VYVGART in multiple autoimmune indications and povetacicept, a new BAFF/APRIL inhibitor with broad potential. We also anticipate approvals for KarXT in schizophrenia and TIVDAK in cervical cancer, both currently under regulatory reviews in China. We're preparing for submissions for other later-stage assets, including Vimatus map for gastric cancer and Tumor Treating Fields for pancreatic cancer. Combined with our broader regional pipeline, these programs position us well for long-term growth. On the global R&D front, we're advancing a pipeline of innovative, globally competitive programs. GL1310, our DLL3 ADC, continues to demonstrate best-in-class potential in small cell lung cancer, as illustrated by the updated data presented at ASCO. We also see encouraging early signals in other difficult-to-treat tumors, such as neuroendocrine carcinoma.

Momentum is building as we head into a period of significant growth supported by multiple near-term allowances.

This include pipeline the product opportunities.

Like zip code in multiple autoimmune indications.

And POV tax accept a deal back April. Inhibitor that brought the potential.

We also anticipate approvals for Cy in schizophrenia.

Antibac in cervical, cancer.

Both currently under regulatory views in China.

We're preparing for submissions for other latest States assets, including premature map for cure cancer.

And tumor treating fields for pancreatic cancer.

Combined with our broader Regional pipeline.

this programs positionals, while for long-term growth

On the globe warranty front.

We're advancing a pipeline of innovative globally, competitive programs.

GL 1310.

Our dl3 ADC.

Continues to demonstrate first in class and passing class potential.

In small cell, lung cancer.

As illustrated by the updated data presented at Asco.

We also see encouraging early signals in other difficult to treat tumors.

Christine Chiou: Beyond that, we're advancing our next wave of innovative global programs into the clinics, including ZL-1503, a bispecific IL-13, IL-31 body for atopic dermatitis, and ZL-6201, our LRRC15 ADC for solid tumors. Business development continues to be a core pillar of our growth strategy. As global interest in China-originated innovation rises, Zai Lab is uniquely positioned to act as a bridge between China's thriving bio ecosystem and global markets. Our deep local know-how and global R&D expertise allow us to source and develop high-potential assets emerging from China and the rest of the world, while continuing to expand our internally discovered global pipeline. We're also leveraging AI across the organization. For example, automating clinical trials, accelerating timelines, and sharpening our commercial analytics. These ongoing efforts are already improving our speed, precision, and efficiency. Going forward, we will apply more AI tools to accelerate our future growth.

Samantha Du: Beyond that, we're advancing our next wave of innovative global programs into the clinics, including ZL-1503, a bispecific IL-13, IL-31 body for atopic dermatitis, and ZL-6201, our LRRC15 ADC for solid tumors. Business development continues to be a core pillar of our growth strategy. As global interest in China-originated innovation rises, Zai Lab is uniquely positioned to act as a bridge between China's thriving bio ecosystem and global markets. Our deep local know-how and global R&D expertise allow us to source and develop high-potential assets emerging from China and the rest of the world, while continuing to expand our internally discovered global pipeline. We're also leveraging AI across the organization. For example, automating clinical trials, accelerating timelines, and sharpening our commercial analytics. These ongoing efforts are already improving our speed, precision, and efficiency. Going forward, we will apply more AI tools to accelerate our future growth.

Such as neuroendocrine tumors.

Beyond that.

For advancing, our next wave of innovative Global programs into the clinics.

Including the 1503.

A bite, specific, our 13 or 31 body for topic dermatitis.

And Co 60201 our lrrc15 ADC for solid tumors.

This development continues to be a core pillar of our growth strategy.

AS Global interests in China oriented, Innovation crisis, sell life is uniquely positioned to act as a bridge between China's thriving bow, ecosystem and Global markets.

Our team local, no home and Global Warranty expertise.

Allow us to source and develop high potential assets emerging from China and the rest of the world.

While continuing to spend our internally discovered Global pipeline.

Ition.

For example.

Automating. Clinical trials. Accelerating timeline

And sharpening our commercial Analytics.

This ongoing experts already improving our speed, precision and efficiency.

Christine Chiou: We remain disciplined in our operations, scaling efficiently while investing strategically in both commercial execution and pipeline innovation. The progress we have made this quarter reinforces our conviction in what Zai Lab is becoming: a profitable, high-growth company with global impact, powered by innovation, disciplined execution, and a deep commitment to delivering long-term values for patients and shareholders alike. Now I turn the cover to Josh. Josh?

Samantha Du: We remain disciplined in our operations, scaling efficiently while investing strategically in both commercial execution and pipeline innovation. The progress we have made this quarter reinforces our conviction in what Zai Lab is becoming: a profitable, high-growth company with global impact, powered by innovation, disciplined execution, and a deep commitment to delivering long-term values for patients and shareholders alike. Now I turn the cover to Josh. Josh?

Going forward, we will apply more AI tools to accelerate our future growth.

We remain disciplined in our operation.

Scaling efficiently while investing strategically in both commercial, execution and pipeline innovation.

The progress we have made this quarter, reinforces our conviction.

Gain what cell life is becoming.

A profitable high growth company with global impact.

This spring execution.

And a deep commitment to delivering long-term values for patients and shareholders alike.

Josh Smiley: Thank you, Samantha. Hello, everyone. Let me start with VYVGART, where strong commercial execution continues to drive momentum in GMG. In Q2, we saw record levels of patient utilization supported by a steady flow of new patient starts and increasing treatment duration. We are seeing a meaningful shift toward maintenance use, a reflection of growing physician confidence in VYVGART's long-term benefits. These positive trends are supported by ongoing physician education and patient support programs aimed at extending treatment duration. We expect this momentum to further accelerate following the July update to China's national GMG guidelines, which meaningfully elevate VYVGART's positioning. The new guidelines recognize minimal symptom expression, or MSE, as the primary treatment goal in GMG and highlight VYVGART's ability to achieve MSE rapidly and durably.

Now, I turn the call over to Josh.

Josh.

Yes. Thank you. Samantha. And hello, everyone.

Let me start with vivart where strong commercial execution continues to drive momentum in GMG.

In the second quarter, we saw record levels of patient utilization, supported by a steady flow of new patient starts and increasing treatment duration.

We are seeing a meaningful shift toward maintenance, use a reflection of growing physician confidence in divarty.

These positive Trends are supported by ongoing physician education and patient support programs aimed at extending treatment duration.

Josh Smiley: VYVGART has the highest MSE rates, ranging from 40% to 73% across clinical studies, and stands out for its rapid onset and deep and sustained efficacy. VYVGART is now recommended for early use in mild to moderate and highly active patients and for sustained long-term treatment to maximize benefit, marking a major step forward for biological adoption for treating gMG in China. We see significant long-term potential for VYVGART. Physicians are initiating treatment earlier and shifting away from steroids, yet VYVGART penetration in gMG is only 10%. We are well-positioned to drive broader adoption and to capture the substantial opportunity that lies ahead. Once listed on NRDL, we believe that subcutaneous formulation will further accelerate uptake by driving deeper market penetration and expanding patient access. The launch in CIDP is also underway, with efforts focused on increasing supplemental health insurance coverage and driving awareness.

We expect this momentum to further accelerate following the July update to China's national MG guidelines, which means we elevate gift cards' positioning. The new guidelines recognize minimal symptom expression, or MSE, as the primary treatment goal in GMG and highlight DivGuard's ability to achieve MSE rapidly and durably.

Gift card has the highest MSE rates ranging from 40 to 73% across clinical studies and stands out for its rapid onset and deep and sustained. Efficacy.

Bidart is now recommended for early use in mild to moderate and highly active patients, and for sustained long-term treatment to maximize benefit.

Marking, a major step forward for biological adoption for treating GMG in China.

We see significant long-term potential for bisgard Physicians, who are initiating treatment earlier and shifting away from steroids. However, Vivart penetration in GMG is only 10%.

We are well positioned to drive broader adoption and to capture the substantial opportunity that lies ahead.

once listed on ennard, we believe that subcutaneous formulation will further accelerate uptake by driving deeper Market, penetration and expanding patient access

Josh Smiley: Our planned submission of the prefilled syringe remains on track and will further differentiate the brand through added convenience and improved adherence. Beyond GMG and CIDP, we are actively pursuing label expansion opportunities across a range of immunology indications with significant unmet need, including seronegative GMG, ocular MG, myositis, lupus nephritis, and Sjogren's. Taken together, these efforts reinforce our view that VYVGART can exceed $1 billion in peak sales and become a foundational immunology brand in China. Turning to the broader commercial portfolio, ZEJULA had a softer quarter due to evolving competitive dynamics within the PARP class. That said, we are already seeing signs of stabilization entering the second half of the year.

The launch in cidp is also underway with efforts focused on increasing supplemental, health insurance coverage and driving awareness.

Our plan submission of the pre-filled syringe remains on track and will further differentiate the brand through added convenience and improved appearance.

Beyond GMG and cidp. We are actively pursuing label expansion opportunities across a range of Immunology indications, with significant unmet need, including Sarah negative GMG ocular mg meiosis. Lupus nephritis, enforce.

Taken together, these efforts reinforce our view that bibart can exceed 1 billion dollars in Peak sales and become a foundational Immunology. Brand in China.

Turning to the broader commercial portfolio.

Had a softer quarter, due to evolving competitive Dynamics, within the park class.

Josh Smiley: We anticipate continued volume expansion across the PARP class and expect ZEJULA's sales to strengthen in first-line ovarian cancer, where it maintains a differentiated safety and efficacy profile supported by strong China patients data and first-to-market advantage. We are confident in ZEJULA's return to growth later this year. XACDURO continues to see robust demand and highly positive feedback from physicians treating CRAB infections, a serious and underserved public health threat in China, with approximately 300,000 Acinetobacter cases annually. As we work to localize manufacturing, supply constraints may modestly limit near-term growth in 2025, but underlying demand remains strong. With Ontyro, we are taking a focused, efficient approach to commercialization.

That said, we are already seeing signs of stabilization entering the second half of the year. We anticipate continued volume expansion across the park class and expect the jewel of sales to strengthen in first line, ovarian cancer where it maintains a differentiated safety and efficacy profile supported by strong China patients data and first to Market advantage,

We are confident as the Jewelers return to growth later this year.

Zakuro continues to see robust demand and highly positive feedback. From Physicians treating crab, infections a serious and underserved Public Health threat in China with approximately. 300,000 ASA, cases, annually.

As we work to localized, manufacturing Supply constraints May modestly limit near-term growth in 2025 but underlying demand remains strong.

Josh Smiley: While near-term revenue is expected to be limited, we believe its best-in-class clinical profile in ROS1-positive non-small cell lung cancer, including strong CNS activity and durability in both TKI naive and pretreated patients, positions Augtyro as an important treatment option for patients. We will continue to pursue efficient ways to broaden our reach to realize the full value of its long-term potential. Turning to our financial position, we continue to execute against our profitability plan, maintaining disciplined spending while investing in growth. For Q2 2025, operating loss improved by 28% to $54.9 million. On an adjusted basis, which excludes certain non-cash expenses, operating loss was reduced by 37% to $34.2 million, keeping us firmly on track to reach profitability on an adjusted basis in Q4. We also expect a strong set of near-term regulatory milestones ahead.

With October, we are taking a focused efficient approach to commercialization.

While near-term revenue is expected to be limited. We believe its best-in-class clinical profile in Ross 1, positive non small cell, lung cancer, including strong CNS activity and durability in both pki naive and pre-treated patients positions on Tyro as an important treatment option for patients.

We will continue to pursue efficient ways to broaden our reach to realize the full value of its long-term potential.

We continue to execute against our profitability plan, maintaining disciplined spending while investing in growth.

For the second quarter of 2025 operating loss improved by 28% to 54.9 million on an adjusted basis. Which excludes certain non-cash expenses. Operating loss was reduced by 37% to 34.2 million. Keeping us firmly on track to reach profitability on an adjusted basis in the fourth quarter.

Josh Smiley: KarXT and TIVDAK are under review by the NMPA. We plan to submit applications for VYVGART's prefilled syringe for GMG and CIDP, bemarituzumab for gastric cancer, and TTFields for pancreatic cancer in the coming months. To support these potential near-term launches, we are leveraging a scalable, resource-efficient commercial model, repurposing teams where possible and targeting field force deployment in high-impact areas. For example, our ZEJULA team will support TIVDAK, our Qinlock team will lead efforts for bemarituzumab, and we plan to cover 85% of the schizophrenia market with a highly focused team of approximately 150 representatives for KarXT. At the same time, we are advancing several operational efficiencies, including scaling support for VYVGART, localizing manufacturing for key products, and improving cost leverage across the portfolio, all of which will drive both strong top-line growth and margin expansion.

We also expect a strong set of near-term regulatory. Milestones ahead, karxt and taimak are under review by the nmpa and we plan to submit an applications for Vis pre-filled syringe for GMG and cidp. Femoratus is a map for gastric, cancer, and TT fields for pancreatic cancer in the coming months.

To support these potential near-term. Launches, we are leveraging a scalable resource. Efficient commercial model, repurposing teams where possible and targeting Field Force deployment in high impact areas.

For example, our zagula team will support tip back. Our kinloch team will lead efforts for Beamer Tusa map and we plan to cover 85% of the schizophrenia Market with a highly focused team of approximately 150 representatives for car XP.

At the same time, we are advancing several operational efficiencies, including scaling support for Vyvgart.

Josh Smiley: Business development remains a strategic priority. We are focused on three core areas: strengthening our global pipeline with externally sourced innovation, expanding our China portfolio with best-in-class assets, and pursuing out licensing and global partnerships to unlock the full value of our pipeline on the global stage. With continued commercial momentum, an innovative and advancing pipeline, and a path to profitability, we are confident in our ability to deliver meaningful long-term growth and value. With that, I will now pass this all over to Rafael to discuss the great progress within our pipeline.

All of which will drive both strong, Topline growth and margin expansion.

Business Development remains a strategic priority. We are focused on 3 core areas.

Strengthening our Global Pipeline with externally sourced, innovation.

Expanding our China portfolio with best-in-class assets and pursuing out licensing and Global Partnerships to unlock the full value of our Pipeline on the global stage.

With continued commercial momentum, and Innovative and advancing Pipeline and a past profitability. We are confident in our ability to deliver meaningful long-term, growth and value.

Rafael Amado: Thank you, Josh. I'll start with highlights from our global pipeline since our last earnings call. Then cover upcoming milestones. Let's start with ZL-1310 or zocilurtatug pelitecan or Zoci for short, our first-in-class DLL3 targeting ADC for small cell lung cancer and other neuroendocrine tumors. At ASCO this year, we presented dose-finding results in patients with previously treated extensive stage small cell lung cancer. Across all dose levels in the second line setting, the unconfirmed response rate was 67%. The disease control rate was 97%. The most promising combination of response and tolerability was observed at 1.6 mg/kg, which showed a 79% unconfirmed overall response rate. A 100% control rate of the disease, which is among the strongest efficacy response signals seen in this setting to date.

And with that, I will now pass the call over to Rafael to discuss the great progress within our pipeline. Thank you. Josh, I'll start with highlights from our Global pipelines since our last earnings call. And then cover upcoming milestones,

Let's start with zero 1310 or so to alert the politician or zoie for short. Our first in class el3 targeting ABC for small cell, lung, cancer, and other neuroendocrine tumors at ASCO this year we presented those finding results in patients with previously treated, extensive stage small cell, lung cancer,

Across all those levels in the second line setting, the unconfirmed response rate was 67% and the Disease Control rate was 97%.

Rafael Amado: At a median follow-up of 3.4 months, median duration of response had not yet been reached. Twenty-nine of 38 responders remain on study. Importantly, we observed compelling intracranial activity, an important unmet need in small cell lung cancer, where up to 70% of patients develop brain metastases. Among these patients, the ORR was 68%, and it was 86% in patients without prior cranial irradiation. Again, the highest intracranial responses reported. Zoci also demonstrated a well-tolerated and differentiated safety profile. At target doses below 2 milligrams per kilogram, there were no grade 2 or higher interstitial lung disease cases, and grade 3 and above treatment-related adverse events occur in just 6% of patients with no drug-related discontinuation.

The most promising combination of response and vulnerability was observed at 1.6 milligrams per kilogram, which showed a 79% unconfirmed overall response rate and a 100% control rate of the disease. This is among the strongest efficacy and response signals seen in this setting today.

At a medium. Follow-up was 3.4 months median duration of response, had not yet been reached and 29 of 38 responders remain on study.

Importantly, we observed compelling intracranial. Activity and important amenities in small cell lung cancer were up to 70% of patients developed brain metastases

And on this patience, the Orr was 68% and it was 86% in patients without prior cranial. Irradiation again, the highest intracranial responses reported

SOI also demonstrated a well, tolerated and differentiated safety profile.

Rafael Amado: This data support the potential of Zoci as a clinically meaningful treatment for patients in second-line small cell lung cancer and other lines of therapy, either as monotherapy or in combination. We're pleased to receive a Fast Track designation from the FDA in small cell lung cancer, adding to the Orphan Drug Designation granted earlier this year, and are pursuing Breakthrough Therapy Designation. We have aligned with the FDA on the accelerated approval pathway and are finalizing details on the pivotal study design in second-line small cell lung cancer. We remain on track to initiate the registrational study later this year. Given its favorable safety profile at 1.6 milligrams per kilogram, Zoci is also well-suited for use in the first-line setting.

A Target doses below 2 milligrams per kilogram. There were no grade 2 or higher interstitial lung disease cases, and grade 3. And above treatment related Adverse Events occur, in just 6% of patients with no drug related discontinuation.

This data support the potential associate as a clinically meaningful treatment for patients in second lines, small cell, lung cancer, and other lines of therapy either as monotherapy or in combination, we're pleased to receive a FasTrak designation from the FDA in small cell. Lung cancer adding to the orphan drug designation, granted earlier this year and are pursuing brexit therapy, designation

we have a line with the FDA on the accelerated approval pathway and are finalizing details on the pivotal study design in second line, smoke Salon cancer,

We remain on track to initiate the registration of study later this year.

Rafael Amado: We are rapidly enrolling patients in a combination dose escalation portion of the study, which will be followed by dose optimization and then a pivotal combination trial after the defined follow-up period. We expect to provide a clinical trial update of Zoci in combination with atezolizumab in the next year. Beyond small cell lung cancer, Zoci is also being studied in other neuroendocrine carcinomas, where enrollment is ongoing in a global phase I, II study, which may have registration potential pending regulatory discussions. We plan to present preliminary data at a medical conference in the first half of the next year. Moving to ZL-1503, our internally developed IL-13/IL-31 bispecific antibody for atopic dermatitis. In June, we presented preclinical data showing durable dual inhibition of both itch and inflammation pathways.

It's also well suited for use in the Frontline setting.

We are rapidly enrolling patients in the combination dose. Escalation portion of the study, which will be followed by those optimization and then a pivotal cam computation trial after the defined follow-up period.

We expect to provide a clinical trial update of Seco in combination with a Tesla map in the next year.

Beyond small, lung cancer. So it's also being studied in other neuroendocrine carcinomas where enrollment is ongoing in a global Phase 1 to study which may have registration potential pending regulatory discussions, we plan to present preliminary data at a medical conference in the first half of the next year. Moving to CL 1503, are internally developed by 13 IO 31 by specific antibody for a topic dermatitis.

Rafael Amado: While IL-4/IL-13 inhibitors have markedly improved outcomes in atopic dermatitis, symptoms mediated by IL-31 often remain only partially alleviated, contributing to limited and incomplete clinical responses to currently available medications for many patients. ZL-1503 dual mechanism and extended half-life may enable less frequent dosing and more comprehensive disease control. We are on track to initiate a phase 1 study for moderate to severe atopic dermatitis later this year, with both IV and subcutaneous formulations progressing as planned. Importantly, 1503 exhibits immunomodulatory properties that are extending beyond atopic dermatitis, with potential applications across a range of interleukin-driven diseases, laying the foundation for a pipeline of future indications. More broadly, across our global portfolio, we're advancing our internal discovery efforts in parallel. We are actively pursuing external opportunities to expand our pipeline with early-stage compounds from China and beyond. Turning to our regional programs.

in June, we presented preclinical data showing durable dual inhibition of both each and inflammation pathways

while iso4 il13 Inhibitors, have marketed outcomes in a topic dermatitis symptoms. Mediated by all 31 often remain only partially alleviated contributing to limited and incomplete, clinical responses to currently available medications for many patients.

Do 1503 dual mechanism, and extend, the half-life may enable less frequent dosing and more comprehensive Disease Control.

We are on track to initiate a phase 1, study for moderate to severe atopic dermatitis later this year, with both Ivy and subcutaneous formulations progressing as planned.

Importantly, 1503 exhibits, immunomodulatory properties, that are extending Beyond a topic dermatitis with potential applications across a range of interloop line of future indications.

More broadly across our Global portfolio. Where advancing our internal Discovery efforts in parallel.

Rafael Amado: Let's start with oncology. Bemarituzumab, a first-in-class FGFR2B-targeting therapy for gastric cancer. In June, we announced positive top-line results from the global Phase 3 FORTITUDE-101 study in first-line FGFR2B-positive gastric and gastroesophageal junction cancer. Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in patients with unresectable, locally advanced, or metastatic gastric or gastroesophageal junction cancer with FGFR2B overexpression and who are non-HER2-positive. FGFR2B overexpression was defined as 2+ or 3+ staining greater than 10% of tumor cells by centrally performed immunohistochemistry. The most common treatment effects, adverse events, in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, Keratitis, anemia, neutropenia, nausea, corneal epithelium defect, and dry eye.

We are actively pursuing external opportunities to expand our Pipeline with early stage compounds from China and Beyond.

Now, turn into our regional programs, let's start with oncology.

The Muma a first in class, FTS are 2v targeting therapy for gastric cancer.

In June, we announced positive Topline results from the global phase 3, 42 to 101, studying first line stfr, 2B positive, disaster of a deal Junction cancer.

And my do some chemotherapy demonstrated that statistically, significant and clinically meaningful Improvement in overall survival as compared to Placebo plus chemotherapy in patients, with unrespectable locally Advanced or metastatic gastric or gastric esophageal Junction cancer with ft fr2. V of our extraction, and we are known her to positive.

FGFR2 overexpression was defined as 2+ or 3+ staining greater than 10% of tumor cells by centrally performed immuno stream.

Rafael Amado: While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 of the bemarituzumab arm. This data, which our partner Amgen plans to present at an upcoming medical meeting, support a regulatory submission in China. Meanwhile, we look forward to the top-line results from our second global Phase 3 study, 4202, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab in patients with first-line gastric cancer. Phase 3 data readout is anticipated in the second half of 2025 or the first half of 2026. In pancreatic cancer, our partner, Novocure, announced positive results from the Phase 3 PANOVA-3 trial evaluating Tumor Treating Fields with chemotherapy in newly diagnosed patients with unresectable locally advanced pancreatic adenocarcinoma.

The most common treatment effects uh Adverse Events uh in patient treated with varus chemotherapy were reduced visual Acuity, keratitis anemia and neutropenia nausea uh corneal epithelium defect and dry eye.

While ocular events were consistent with the face to experience and observe in both arms, they occur with greater frequency and severity in the face 3 the Meritus of alarm.

This data, which our partner plans to present at an upcoming medical meeting, supports a regulatory submission in China. Meanwhile, we look forward to the topline results from our second global Phase 3 study 42102, a Phase 1b/3 study of a marathon and evolvement in patients with first-line gastric cancer.

I see that I read out is anticipated in the second half of 2025 for the first half of 2026.

Rafael Amado: The study met its primary endpoint of overall survival, representing the first Phase 3 study success in this setting. We believe this therapy could meaningfully expand treatment options for patients with limited alternatives in pancreatic cancer, and we expect to submit in China this year. Now moving to our key late-stage regional programs in immunology. For efgartigimod, we continue to explore its potential to treat other IgG-mediated autoimmune indications, including thyroid eye disease or TED, myositis, seronegative gMG, ocular MG, Sjogren's disease, and lupus nephritis. In the second half of this year, we expect top-line results from the global Phase 3 study of seronegative gMG and the Phase 2 study of lupus nephritis. In addition, we will join the registrational UNITY study of efgartigimod subcutaneously administered by prefilled syringe in Sjogren's disease in Greater China in Q3 of this year.

In pancreatic cancer, our partner novocure announced positive results. From the 5th Street pinova 3 to evaluating tumor, treating Fields with chemotherapy in. Newly diagnosed patients with unresectable locally Advanced pancreatic adenocarcinoma.

The study met its primary and point of overall survival representing the first phase 3 study uh success in this setting.

We believe this therapy could meaningfully expand treatment options for patients with limited Alternatives in pancreatic cancer and we expect to submit in China this year.

No, moving to our key late stage, Regional programs in Immunology,

My sites, their negative GMG ocular, mg shrines disease and lupus nephritis.

In the second half of this year, we expect Topline results from the global history study of s negative GMG and the face to study of lupus nephritis.

Rafael Amado: Povetacicept is a dual antagonist of the BAFF and APRIL pathway. China has already joined the global phase 3 RAINIER trial in IgA nephropathy, and enrollment of the interim analysis cohort is now completed. Our partner, Vertex, will conduct an interim analysis once this cohort reaches 36 weeks of treatment, with the potential to file for accelerated approval in the US in the first half of 2026. We also plan to join the global pivotal phase 2/3 study in primary membranous nephropathy, expected to start in the second half of this year. Moving to VRDN-003, an anti-IGF-1R antibody, a potentially best-in-class therapy in thyroid eye disease. It has the same binding domain as elegrobart, and it is administered subcutaneously. Elegrobart has consistently demonstrated reductions in proptosis, diplopia, and clinical activity score across both active and chronic thyroid eye disease in phase 3 studies.

In addition, we will join the registrational. Unity study of a particular subcutaneously administered by pre-filled syringe in struggling China. In the third quarter of this year

Obviously, s is a dual of the buff on April pathway.

China has already joined the global phase 3 reniers trial in IGA nephropathy, and enrollment of the interim analysis. Cover is now completed.

Our partner vertex will conduct an interim analysis. Once this cohort, reaches 36 weeks of treatment with the potential to file for accelerating approval, in the US, in the first half of 2026,

We also plan to join the global of Philadelphia Phase 23 study in primary member of nephropathy expected to start in the second half of this year.

Moving to VRDN-003, an anti-IDF 1R antibody, a potentially best-in-class therapy in thyroid eye disease.

Rafael Amado: The infrequent dosing regimen of every 4 weeks or every 8 weeks presents significant potential as a transformative option for patients with TED. The two global registrational REVEAL-1 and REVEAL-2 studies are enrolling. Our partner, Viridian, is expected to provide top-line results in the first half of 2026. We are working on initiating phase 1 PK study in China and a phase 3 registrational study in TED upon CDE agreement expected in Q4 2025. These updates underscore our continued focus on pipeline renewal as well as discovery and development, innovation, and execution across oncology and immunology. I look forward to sharing further progress updates in the coming quarters. Now, Yajing will give an overview of our financial results. Yajing?

It has the same binding domain as related drugs and it is administered. Subcutaneously has consistently demonstrated reductions in proptosis diplopia and clinical activity score across both active and chronic started idc's in Phase 3 studies.

the infrequent dosing regimen of every 4 weeks or every 8 weeks, present significant potential as a transformative option for patients with CAD

The two global registrations of Reveal 1 and Reveal 2 studies are enrolling, and our partner, Videon, is expected to provide topline results in the first half of 2026.

we are working on initiating Phase 1 PK study in China and a phase 3 registration was studying Ted upon CDE agreement expected in the fourth quarter of 2025

These updates underscore our continuous, focus on Pipeline renewal as well as Discovery and development, Innovation and execution across oncology and Immunology.

Yajing Chen: Thank you, Rafael. I will discuss highlights from our Q2 2025 financial results compared to the prior year period. Total revenue grew 9% year-over-year to $110 million in Q2, primarily driven by higher sales of VYVGART, supported by durational therapy expansion and increase in market penetration, as well as Vydura, which was launched since Q4 2024. Our focus on financial discipline and efficiency efforts was also reflected on the expenses side. R&D and SG&A as a percentage of revenue declined significantly year-over-year. R&D expenses for Q2 decreased 18% year-over-year, mainly due to decreased personnel costs and the clinical trial costs as a result of resource prioritization and efficiency efforts.

I look forward to sharing further progress updates in the coming quarters. And now yeah, Gene will give an overview of our financial results.

Again.

Thank you. Raphael, now I will discuss highlights from our second quarter 2025 financial results compared to the prior year period.

Total revenue grew 9% year-over-year to 110 million in the second quarter.

primarily driven by higher sales of vehicles, supported by duration of therapy, extension and increasing Market penetration,

as well as the Dora which was launched since the fourth quarter of 2024,

Our focus on financial discipline and efficiency efforts was also reflected on the expense side.

R&D and HDA as a percentage of Revenue declined, significantly year-over-year.

Yajing Chen: SG&A expenses for the Q2 decreased 11% year-over-year, mainly due to the strategic resource allocation and the efficiency improvements. As a result of operating leverage we're building into our business, our loss from operations decreased 28% for the Q2 to $54.9 million. When you adjust our loss from operations to exclude certain non-cash items, specifically depreciation, amortization, and share-based compensation, we had adjusted loss from operations of $34.2 million in the Q2, reflecting year-over-year improvement of 37%. Based on our operating plan and our anticipated revenue growth, we expect to achieve profitability on the adjusted basis by the Q4 of this year. Looking ahead, we expect to deliver quarter-over-quarter total revenue growth in 2025, with a meaningful acceleration anticipated in the later part of the year.

On the expenses for the second quarter, decreased 18% year-over-year. Mainly due to decreased Personnel costs and the clinical trial costs as a result of resource prioritization and efficiency efforts.

188 expenses for the second quarter, decreased 11% year-over-year, mainly due to the Strategic resource allocation and efficiency improvements.

As a result of operating leverage, we're building into our business.

Our large farm operations, decreased 28%, for the second quarter to 54.9 million.

When you adjust our last 4 operations to exclude certain non-cash items. Specifically depreciation amortization and share based compensation.

We had adjusted lot from operations of 34.2 million dollars in the second quarter.

Reflecting year-over-year Improvement of 37%.

Based on our operating plan and our anticipated Revenue growth.

We expect to achieve profitability on the adjusted basis by the fourth quarter of this year.

Yajing Chen: We remain confident in reaffirming our full year 2025 total revenue guidance of $560 million to $590 million. This revenue forecast reflects strong growth for ZEJULA franchise, continued growth for our base business, and contributions from newly launched products. We are in a strong financial position, ending the quarter with a cash position of $832.3 million. With that, I'd now like to turn the call back over to the operator to open up line for questions. Operator?

Looking ahead. We expect to deliver a quarter over quarter total revenue growth in 2025, with a meaningful acceleration and anticipated in the later, part of the year.

This revenue forecast, reflects strong growth for Visa franchise continued growth for our base business and contributions from newly launched products.

We are in a strong financial position and in the quarter with a cash position of 832.3 million.

And with that, I would now like to turn the call back over to the operator to open up 9 for questions.

Operator: Thank you. We will now open the line for questions. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. We will now take our first question from the line of Jonathan Chang from Leerink Partners. Please go ahead, Jonathan.

Operator.

Thank you.

We will now open the line for questions to ask a question. Please press star 1, 1 on your telephone and wait for your name to be announced to withdraw your question. Please press star 1 1 again.

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

Jonathan Chang: Hi, guys. Thanks for taking the questions. First question. Congrats on the positive FORTITUDE-101 study results. Can you help us understand the potential opportunity for Bema in frontline gastric cancer? What biomarker status and FGFR2b threshold would patients need for treatment with Bema? Can you help us characterize the safety profile observed in the 101 study?

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

Josh Smiley: Morning, Jonathan, it's Josh. Thanks for the message. I'll start on commercial and then turn it over to Rafael to talk a little bit more about the profile. First, you know, there's over 450,000 patients with gastric cancer in China. A third of about a third of whom overexpress FGFR2B. Very significant patient population. I think given what we know of the clinical benefits of this product and potential treatment duration, we're, you know, quite excited and confident that there's over time, a billion-dollar sales potential opportunity in this potential indication. We're already in this space with Qinlock. We've got about 100 sales reps who promote Qinlock today.

Question: Congrats on the positive 42-101 study results. Can you help us understand the potential opportunity for Bimmia and Frontline in gastric cancer? What biomarker status and FGFR2? Be threshold with patients in need of treatment with BMA and can help us characterize the safety profile observed in the 101 study.

Josh Smiley: We'll use that sales force and build on it to take advantage of the opportunity here. Again, we're quite excited by this product. It's gonna deliver significant benefits to a very big patient population in China, and I'll ask Rafael to make some more comments.

Rafael Amado: Yeah. Thanks, Josh. Thanks for the question. As I said in the prepared remarks, this is a drug for patients with overexpression of FGFR2B, and that's about a third of patients, 30% or so. The cutoff is 2+ to 3+, at least 10% of the cells. In terms of patient numbers, it's, you know, close to 140,000, 150,000 new cases in China per year, which is very sizable. We are preparing to launch this product with diagnostic as well.

Good morning. Uh, Jonathan, it's Josh. Thanks for the message. I, I'll start on Commercial and then turn it over to Rafael to talk a little bit more about the, the profile. First, you know, there's over 450,000 patients with gastric cancer in China. Uh, the third of about a third of whom overexpressed fgfr to be. So, very significant patient population. And I think given what we, uh, know of the clinical benefits of of this product, and, and potential treatment duration, uh, we're, you know, quite, quite excited and confident that there's a overtime, a billion dollar, uh, sales potential opportunity, in this, um, in this potential indication, we're already in, uh, in this space with kinloch, we've got about a hundred sales reps, who promote kinloch today, we'll use that sales force and build on it to, uh, take advantage of the opportunity here. And again, we're we're quite excited by this uh, this product. It's going to deliver significant benefits to a very big patient population in China.

And I'll ask Raphael to make some more comments. Yeah, thanks Josh. Uh, um, and thanks for the question. Uh, as I said in the prepared remarks, this is, uh, um a a drug for patients with our expression of FDA for to be uh and that's about a third of patients 30% or so. Uh the cutoff is uh uh 2 plus 3 plus uh, at least 10% of the cells.

Rafael Amado: In terms of the toxicity, as I mentioned, the key toxicity was mild suppression, which is probably more related to chemotherapy and then ocular toxicity, which was expected, and it was seen in the Phase 2 study, the PHI trial. Toxicity greater than 25% included mostly corneal toxicity that affected visual acuity. Either contact keratitis or epithelial defects as well as dry eyes. We saw this actually in the placebo arm as well. It's more pronounced in the treatment arm and more common in the 101 study than it was seen in the Phase 2 study. That may be because we included a more comprehensive and standardized ocular monitoring in that trial. This is expected.

Um, so, uh, in terms of patient, numbers is, you know, close to 140, 150,000 new cases in China, uh, per year, which is uh, very sizable. And we, um, are preparing to to launch the product with diagnostic as well.

Um, in terms of the toxicity, uh, as I mentioned, the GTO system was not suppression, which is probably more related to chemotherapy and then ocular toxicity, which was expected and it was seen in the phase 2 study the, the fight draw.

Rafael Amado: As I said, the receptor is expressed in epithelial cells in the cornea. It can be monitored by ocular consultation. Patients can be prophylaxed. It happens well into the treatment, so it doesn't happen right away. At least in the phase 2 study, they were reversible. The details of all the safety will be presented at an upcoming meeting that Amgen has guided towards. In terms of, you know, how this will play out with regards to benefit risk, well, you know, it depends on the benefit that you will see when the presentation comes up.

So, uh, toxicity greater than 25% included uh, mostly corneal, uh, toxicity, uh, that affected the visual Acuity. Uh, so, um, either um, contact keratitis or epithelial defects as well as dry eyes. Um, and we saw this actually in the Placio arm as well, um, uh, but it's more pronounced uh, in the treatment arm and uh, more common in the uh, 101 study than it was seen in the phase 2 study. Um and that maybe because we included a more comprehensive and standardized ocular um monitoring in that trial.

Rafael Amado: These are patients that have a particularly poor prognosis, and there is a meaningful treatment effect that, you know, needs to be taken into account with this very aggressive form of cancer that has very limited treatment options.

Jonathan Chang: Understood. Maybe second question, if I may. Can you discuss your confidence levels in achieving your 2025 revenue guidance?

Jonathan Chang: Understood. Maybe second question, if I may. Can you discuss your confidence levels in achieving your 2025 revenue guidance?Profitability goal by year end. How should we think about the contribution of VYVGART in achieving these goals? Thank you.

The presentation comes up, um, but uh, these are patients that have a particularly poor prognosis. Um, and there is a a meaningful, uh, treatment effect that uh, um, um, you know, needs to be taken into account. Uh, with this very aggressive form of cancer that has very limited treatment options.

Understood.

Yigal Nochomovitz: Profitability goal by year end. How should we think about the contribution of VYVGART in achieving these goals? Thank you.

Josh Smiley: Thanks, Jonathan. It's Josh. First, we reaffirmed our top-line guidance of $560 million to $590 million in sales. Obviously we're confident in that range. On profitability, we also have reconfirmed that we see us achieving profitability on a non-GAAP basis in Q4. I think full speed ahead on both of those. As it relates to the sales, we do expect accelerating growth in the second half of this year, driven certainly by VYVGART as one of the big drivers here.

And maybe second question if I may, um, can you discuss your confidence levels in and achieving your 2025 Revenue guidance and profitability goal by year end? And how should we think about the contribution of of Viv guard, uh, in achieving these goals? Thank you.

Josh Smiley: We're pleased with our performance in Q2, saw, you know, record patient numbers in terms of patient starts, and we're seeing, you know, every month, we're seeing an increase in patient duration or numbers of doses or cycles per patient. We expect that to accelerate in the second half of the year, both as we continue to build experience with physicians and patients, but also leveraging the new national guidelines for gMG that were issued in July. You know, you should expect to see the kind of quarter-over-quarter acceleration or a growth in sales for VYVGART that we saw in Q2. Again, we're quite happy with those trends. ZEJULA, we expect growth in the second half of the year.

Thanks Jonathan. It's Josh, uh, first, you know, we reaffirmed our, uh, Topline guidance of 560 million to 590 million dollars in sales. So obviously we're we're confident, uh, in in that range. Um, and on profitability we also, uh, have reconfirmed that we see us achieving, uh, profitability on the non non-cap basis, um, in Q4. So I, I think, uh, Full Speed Ahead on both of those as it relates to the sales, we do expect uh accelerating growth in the second half of this year uh driven uh certainly by Viv guard, as 1 of the big drivers here, we're pleased with our performance in the second quarter. Uh, saw you know, record patient numbers in terms of patient starts and we're seeing, uh,

Josh Smiley: We did see some declines in Q2, but I would say that's mostly related to the choppiness and disruption that comes with a major competitor going off patent, that's Lynparza and, you know, new competitors coming on. We're quite confident in our position with ZEJULA as the market leader in first line ovarian cancer. Again, we are already seeing good recovery in Q3, so we'd expect to see sales growth there. Again, confident about the trajectory and the shape of the growth for the second half of the year. With that growth then, if you look at our overall operating expenses, that growth drives us towards profitability.

You know, every month we're seeing an increase in patient, um, duration or numbers of doses or cycles per patient. We expect that to accelerate in the second half of the year, uh, both as we continue to build experience with, um, uh, with Physicians and patients. But also leveraging the new National guidelines for, uh, GMG that were issued in July. So, uh, you know, you should expect to see the kind of, um, quarter of a quarter acceleration in in or, or a growth in sales for vivart that we saw in the second quarter. And again, we're we're quite happy with those Trends. Um, so joola we expect growth in the second half of the year. We did see some, uh, uh, declines in the second quarter. But I would say, that's mostly related to the the choppiness and, and, um, uh, disruption that comes with a major, uh, competitor going off patent, that's limp, para, uh, and, uh, you know, new competitors coming on, but we're we're quite, uh, uh, uh, to, um,

Josh Smiley: You know, if you look historically quarter-over-quarter, we continue to see good improvement each quarter and have good confidence that we'll get there in Q4 of this year. Thanks.

Confident in our position with the, juul as the market leader, and first line, uh, ovarian cancer. And again, we are already seeing good recovery and the the third quarter. So we would expect to see sales growth there. So again, uh, confident about the trajectory and the shape of the growth for the second half of the year with that growth. Then if you look at our, uh, overall operating expenses, um, that growth drives us towards profitability. And, you know, if you look historically quarter over quarter, we continue to see

Yigal Nochomovitz: Thanks for taking the questions.

Jonathan Chang: Thanks for taking the questions.

Good Improvement, each quarter and uh, uh, have good confidence that we'll get there in the fourth quarter of this year. So, thanks,

Operator: Thank you. Our next question comes from the line of Anupam Rama from J.P. Morgan. Please go ahead, sir.

thanks for taking the questions.

Thank you.

Anupam Rama: Hey, guys, thanks so much for taking the question. You talked about the second half growth levers with VYVGART, and you talked about the stabilization of Zejula, looking to the second half, but just wondering if there's any outsized growth expected from the broader commercial franchise in terms of Nuzyra or XACDURO that might, you know, contribute meaningfully to getting to guidance and profitability by the end of the year?

Our next question comes from the line of anupam Rama from JP Morgan. Please go ahead sir.

Josh Smiley: Thanks, Anupam. It's Josh. Yeah, I think first, if you look at Zagdoro and Onkyro, both of, you know, both products are in the beginnings of the launch phases. We're really excited about the potential of both products. I think with Zagdoro, we expect to see continued good growth. As we mentioned it in the beginning of the call, I think the demand is strong. We're still working through, you know, supply and making sure we can fill as much of that demand as possible. The more product we can, we can get into the country, the better off we'll be. We should expect to see continued good growth there, somewhat limited, I think, in the second half of the year by supply constraints.

Hey guys, thanks so much for taking the question. Um, you talked about the the second half growth lovers with, um, this card and you talked about the stabilization of Zula, um, looking to the second half, but just wondering if, if there's any outsized growth expected from the broader commercial franchise in terms of new Zyra or extura that might, you know, contribute meaningfully to getting to getting to, to to to, to guidance and profitability by the end of the year.

Thanks Anna Paul, it's Josh. Um, yeah, I I think first, if you look at Zack Doro and OG Tyro, both of, you know, both products are in the beginnings of the launch phases were really um, excited about the potential of both products. I think was Zack Doro. She expect to see continued good growth as we mentioned that in the beginning of the the call, um I think the the demand is strong. Uh we're still working through, you know, Supply and making sure we can fill as much of that demand as possible. So the more product we can, uh, we can generate get into the, the country, the, the better off we'll be and, and, uh, we should expect

Josh Smiley: I think long-term for this product, we're, you know, quite excited. I think with Onkyro, we're taking a focused approach to the launch here, but also would expect to see good growth in the second half of the year. We have good pricing on NRDL, and of course, this is a product for patients with the mutation that provides really significant benefit. I think as you know, look at your models, having more growth in the second half of the year from those products is important. NUZYRA continues to be a strong driver of growth for us and expect that to continue in the second half as well.

Patients with the mutation that provides really significant benefit. So yeah. So I I think as you, you know, look at your models having, um, more growth in the second half of the Year from from those products is important. As Ira continues to be a, a strong driver of growth for us and and uh, expect that to continue in the second half as well.

Anupam Rama: Thanks so much for taking the question.

Josh Smiley: Thanks, Anupam.

Thanks so much for taking a question.

Operator: Thank you. We will now take our next question from the line of Yigal Nochomovitz from Citigroup. Please ask your question, Yigal.

Thanks.

Thank you.

Yigal Nochomovitz: Yeah. Hi. Thank you very much. I had a bunch of questions on the bemarituzumab topic. Obviously, you can't tell us the data, but you have said that it's statistically significant and clinically meaningful. Obviously in FIGHT, in the Phase 2 FIGHT trial, the OS delta was over 13 months. Can you just help put in perspective what the expectations should be around the OS data for 4201 in terms of the expected delta? Then for 4202, given that it's with nivo, I'm also curious whether you would expect that the delta would be less because you have nivo on both sides of the equation.

We will now take our next question, from the line of ego. No, to Move It from City Group. Please ask your question ego.

Yeah. Hi. Thank you very much. Uh, I had a bunch of questions on, on the bema topic. So obviously, you can't tell us the data, but you have said that, it's statistically significant and clinically meaningful and obviously, in fight, uh, in the phase 2 fight trial, the the OS, Delta was

Yigal Nochomovitz: Also in China, what's going to be the regimen that is more likely to get the uptake in gastric? Is it with the chemo or also with the nivo? Thank you. I have another one on DLL3. Thank you. I'll ask Rafael to jump in here on the question, Yigal. Thanks.

Over over 13 months. So can you just help put in perspective, what the expectations should be around the the OS data for um, for 4 to 2 101? In terms of the the expected Delta, um, and then for 1 102 given that it's with nivo, I'm also curious whether you would expect the, the Delta would be less because you have Neo on both sides of the equation.

And then also in China, what's going to be the the regimen that is more likely to get the uptake in in uh, in gastric. Is it with the chemo or also with the, uh, with the Neo?

Josh Smiley: I'll ask Rafael to jump in here on the question, Yigal. Thanks.

Thank you. And then I have another 1 on T3. Thank you.

Rafael Amado: I mean, I think with regards to the magnitude of the treatment effect, I'm afraid I can't comment because it's embargoed until the presentation, obviously. I think other than the qualitative statements that Andre and us have made with regards to the clinical meaningfulness of the differences between placebo and Bema, I can't really say very much more. So stay tuned for that. I think with regards to the differences in survival between what is seen in one oh one and one oh two, again, I would be speculating. The difference in survival of nivo in gastric and G junction tumors is not very pronounced. As you know, it's about a couple of months or so.

I'll I'll ask Rafael to jump in here on the on the questions. You call. Thanks.

Rafael Amado: You know, if one maintained, you know, the same sort of survival difference with Bema, you know, you could potentially have an additive effect to that, those two months. Again, difficult to speculate. We will know when we see, you know, when we see the data. In terms of uptake in China, it's difficult to tell, but FORTITUDE-101 is a particularly important study for us in China. The use of nivo is relatively low, but there are other PD-1 inhibitors and many patients are treated without PD-1 as well. Chemotherapy plus Bema, if it's perceived to be a very important advance, it will be used.

Yeah, I mean, I think with regards to the magnitude of the treatment effect, I'm afraid. I can't comment because, uh, it's uh, uh, embargoed until the presentation of obviously. Um, uh, but uh, I think, uh, other than the qualitative statements that uh, I'm doing. And as made with regards to the uh, clinical meaningfulness of of of the differences between uh, black people and Dina um, I can't really say very much more and and so stay tuned for that. I think with regards to the differences in uh um, survival between what is seen in 101 and 102 again. I would be speculating, um, the difference in survival of New Orleans gastric and G Junction, tumors is not, um, very pronounced as you know, it's about a couple of months or so. Um, you know, 1 maintain, you know, the same sort of survival difference with dimma, um, you know.

Rafael Amado: It remains to be seen how much traction the PD-1 inhibitor will have. You know, there will be a difference in time also, of the launch of one versus the other, which may affect as well, uptake of a potential PD-1. I'm afraid I can't really give you I mean, a concise and accurate answer, but this is sort of my qualitative statement.

You, you could potentially have and add it to the factory that those 2 months, but uh, Again difficult to speculate, uh, and then we will know when when we see, um, you know, when we see the data and then in terms of uptake in China. Um, um, it's difficult to tell but the the 101 is a particularly important study for us in China. Um, the the the use of Neo is, uh, relatively low, but there are other, uh, P1 Inhibitors and and many patients are treated without P1 as well. Um, and, uh, so chemotherapy plus plus BMA, if it's perceived to be, uh, uh, uh, a very important Advanced, uh, it will be used. Uh, so, uh, it remains to be seen how much, uh, destruction, the be1 inhibitor will have. But, um, you know, there will be a difference in time also, uh, of uh, the launch of 1 versus the others, which may affect

Yigal Nochomovitz: Okay. All right. For the DLL3, it looks like you're somewhere in the 1.6 mg/kg for the dose that you've so far. With the combo with the Tezo, how are you thinking about the combo dose for DLL3? Do you think you can stay at the 1.6, or may you need to be a little lower potentially for combo tox, or do you see that you're not gonna have, you know, overlapping tox, and it's fine just to go with what you saw already in the monotherapy?

As well, uh, uptake of, uh, of of a potential td1. So I'm afraid I I can't really give you a concise. I mean, a concise and accurate. Uh, answer. But this is sort of my qualitative statements.

Rafael Amado: It's a bit premature to say with certainty, but the toxicity of these two agents are very different. Actually at 1.6, ZL-1310 is very well tolerated. We only had 6% grade three and above. With the non-overlapping toxicities, we believe that the combinability with 1.6 is very possible, and we're working towards that. In addition to that, we're also trying to do an etoposide-sparing regimen as well, we continue to study the triplet with carbo. All this data will, as it matures in terms of follow-up, response, and safety, we will present it most likely in the first half of next year.

Okay, all right. Um, and then for the dl3, so it looks like the, you're somewhere in the 1.6 migs per kg for the for the dose that you've, uh, so far. So, with the combo, with the tzo, what, how are you thinking about the combo dose for for dll3? Do you think you, you can stay at the 1.6 or may you need to be a little lower potentially for for combo talks or do you see that it's not? You're not going to have, you know, overlapping toxin. It's fine. Just to go with the what you saw saw already in the monotherapy.

Um, it's I'll be premature to say uh, with certainty. Uh, but uh, the uh, toxicity of these 2 agents, uh, uh, are are are very different, uh, and actually at 1.6, uh, um,

Yigal Nochomovitz: Okay. If I could have one for Josh. Josh, obviously, there's a lot of momentum with efgartigimod, but you have these four new trials: the lupus, seronegative gMG, myasthenia gravis, and Sjogren's disease. I'm just kinda curious, when you put all those together, how does that change your perspective on the potential overall peak for this drug relative to the, you know, the initial rollout of indications? Can you just kind of frame that so we can get a sort of a zip code of how much more that's gonna drive the overall franchise long term? Thank you.

3 and above. Um, and so um, with the, the non overlapping toxicities, we believe that the combination with 1.6 is uh, is is very possible and we're working uh, towards that. Um, and then um in addition to that we're also trying to do an opposite sparing regimen as well and and we continue to uh to study uh, the triplet with carbo. So um, all this data will as as as it matures in terms of follow-up and response and and safety, uh, we will present it most likely, uh, in the first up and next year,

Josh Smiley: Sure. Thanks, Yigal. you know, first, you know, we've said consistently that over time, we see a greater than billion-dollar sales potential on an annual basis in China for VYVGART when you look at the various indications. I think we're certainly on the way there. Of course, you know, today the opportunity is to drive penetration, usage, and duration in GMG. I think if you look at the indications you mentioned, certainly those that are complementary in the GMG space can add, you know, somewhere, you know, in the range of 25% or more, you know, sort of patient opportunity within GMG. This, you know, this would be ocular and seronegative. Lupus, you know, we're, you know, excited to see the data.

Okay. And and if I could have 1 for Josh, Josh obviously there's a lot a lot of momentum with eschar but you have these 4 new uh trials the lupus or negative GMG my my stenograph of Swords disease. I just kind of curious when you put all those together, how does that change your perspective on the potential overall, Peak for this drug uh, relative to the, you know, the initial roll out of indications, can you just kind of frame the frame that so we can get a sort of a zip code of of how much more, that's going to drive the, the overall franchise long term. Thank you.

Josh Smiley: That's a very, you know, big potential indication but still, you know, still more to come. I think myositis and Sjogren's, again, also pretty big indications. I think if you look at the total patient population, then add in thyroid eye disease, you know, we go from a starting point of about 170,000 patients with GMG in China, to something well over 500,000 when you start to put these indications together. You know, as we've said, the billion-dollar type of opportunity, you don't have to assume, you know, huge penetration rates or otherwise. And again, I think the data that we've seen so far that have been released, you know, give us a lot of confidence that there's gonna be significant benefits across the various indications here.

Sure, thanks eal, you know, first we, you know, we've said, consistently that over time. We see a greater than billion dollar, uh, sales potential on an annual basis in China for uh, for vyvgart

So, I think if you look at the total patient population, then add in thyroid eye disease, you know, we go from a starting point of about 170,000 patients with GMG in China, uh, to something well over 500,000 when you start to put these indications uh together. So uh, you know as we've said the the billion dollar type of opportunity, you don't have to assume, you know, huge penetration rates, or otherwise uh and and again I think the data that we've seen

Josh Smiley: For us today, it's drive penetration in GMG, look forward to the supplementary indications that can build out that patient population. For 2026, get Hytrulo approved through NRDL. We think that'll bring significant patient benefits, then supplement that with the prefilled syringe, which we'll work towards submitting later this year. A lot to come in VYVGART and a lot to be excited about in terms of date, you know, the current performance and things to look forward to.

Yigal Nochomovitz: Got it. Okay. Thank you very much.

So far that that have been released, um, you know, give us a lot of confidence that there's going to be significant benefits across the various indications here. But for us today, it's Drive penetration in GMG look, forward to the supplementary indications that can can build out that patient population for 2026. Get high trullo, uh, approved through ennard, uh, we think that'll bring significant patient benefits, then uh, supplement that with the pre-filled syringe, which will, uh, work towards submitting later this year. So, uh, lot to come in, um, in vyvgart,

Operator: Thank you. As a reminder, before we take our next, it is star one one for questions. We will now take our next question from the line of Ziyi Chen from Goldman Sachs. Please go ahead, Ziyi.

Got it. Okay, thank you very much.

Ziyi Chen: Hi, thank you for taking my questions. Two questions from me. The first one is for VYVGART. I understand that as you mentioned in Q1, there has been some inventory management that lead to weaker sales. I'm wondering, was VYVGART still under this type of inventory management in Q2? How should we look into the second half, and particularly in July, what has been the momentum versus previous months in the first half? Also, we look at argenx, they observed very strong, you know, sub-Q formulation uptake. What will be the strategy in China between sub-Q and the IV formulation for VYVGART from your perspective? My second question is regarding the DLL3 ADC. Now the asset's gonna be moving into pivotal study pretty soon.

Thank you as a reminder before we take our next. It is start 1 1, 1 4 questions. We will now take a next question from the line of Zion from Cox. Please go ahead. Z

Thank you for taming taking my questions. Uh, 2 questions for me. Uh, the first 1 is for this art. Um, I understand that measure mentioned in first quarter, there has been some Inventory management dialing to weaker um, cells, and uh, I'm wondering was Swift car. Still under this type of inventory management and 7 quarter and how she would look into the second half and particularly in July. Uh, what has

The moment.

Ziyi Chen: At this juncture, we're trying to understand a bit more about the company's strategy in the US market. Are you still actively looking for a partner for clinical development? The strategy is going to be pivoting towards self-sponsoring the pivotal study and potentially the future commercialization to capture all the economics? Thank you.

Josh Smiley: Thanks. I'll start on VYVGART and then turn it to Rafael for the discussion on DLL3. I think first on the inventory piece that, you know, I just would remind you that in, you know, 2024 was our first year of launch. As you would in any, you know, new launch product on NRDL, we, you know, built inventory through the year to keep up with demand. At the end of Q4, stocked the channel for the approval of Hytrulo. You do have some inventory, you know, build in the 2024 numbers, again, as you would expect.

Study and potentially future commercialization to capture all the economics. Thank you.

Josh Smiley: I think first half of this year, for VYVGART, we tried to manage that inventory closely. I would say in the second half of the year, you should expect normal types of build to prepare for 2026 and what we, you know, presume will be robust sales, including, as I mentioned in the last discussion or question, our expectation that Hytrulo will be added to NRDL. I think to your, to your question, I think from what we see around the world where Hytrulo is available, it becomes, you know, a very important treatment option and treatment choice relative to IV.

Thanks, I'll I'll start on devart and then turn it to Raphael for the the discussion on dl3. Uh, I think, first on on the inventory piece that, you know, I just would remind you that in, you know, 2024 was our first year of launch and and as you would in any, um, you know, new launch product on ennard, we we, you know, build inventory through the through the year to keep up with demand. And at the end of Q4, uh, stock the channel for the approval of, uh, itool. Um, so you do have some inventory, um, you know, build in, in the 2024 numbers again. At as you would expect, I think first half of this year, uh, for vivart, we tried to, uh, manage that inventory closely. And I would say, in the second half of the year, you should expect normal, uh, types of, uh, Bill to prepare for, uh, 2026. And what we, you know, presume will be robust sales including, uh, as I mentioned, uh, in the last discussion or question,

Josh Smiley: I think we would expect over time that Hytrulo would become a very meaningful formulation for patients with gMG. We'll again pursue NRDL appropriately in that regard. I think as you get into 2026, you should expect to see a, you know, a shift from, of course, today, almost exclusively IV use to significant Hytrulo and then, you know, certainly followed in the coming years by the PFS version as well. I'll ask Rafael to comment then on DLL3.

Our expectation that, um, I trullo will be, um, will be added, uh, to uh, to ennard. And then, uh, I think to your, to your question, I think, from what we see, um, around the world where I trullo is available, uh, it becomes the, you know, a very important, um, uh, treatment option and treatment Choice relative to Ivy. So I, I think we would expect

Rafael Amado: Yeah. With regards to the pivotal trial, we have said before that we've been in discussions with FDA, and this accelerated approval pathway is still viable. It would be a randomized trial, and we're on track to initiate this trial before the end of the year. We have to align on the dose, as we presented at ASCO, 1.6 mgs per kilogram is looking very strong and probably the best sort of combination on benefit risk. We will continue to generate data. We will present some data as well on the durability. Our goal is to get agreement on the dose and initiate this trial.

Expect over time that high trullo would become a, a very meaningful, um, formulation for patients with, uh, with the GMG and will, uh, again will pursue an RDL appropriately in that regard. So, I think as you get into 2026, you should expect to see, uh, uh, you know, a shift from, uh, of course today almost exclusively IV use to uh, significant high trouillot. And then, you know, certainly followed uh, in the in the coming years by the the the PFS version as well. Um, I'll ask Rafael to comment them on dl3.

Rafael Amado: You know, with regards to partnership, our, you know, initial pursuit is gonna be to go ahead and launch this trial ourselves. You know, the discussions, I think we may remain open, but we're pretty committed to moving this forward by ourselves, and this study will be launched by us.

Yeah, so with regards to the uh, pabel trial. Um, we said before that, we've been in discussions with FBA, um, and uh, the suo pathway, uh, is still viable. Um, it would be around the last trial, and we're on track to initiate this trial before the end of the year. Uh, we have to align on the dose, but, uh, as we present the Rosso 1.6 mix per kilogram is looking very strong and probably the best sort of combination and benefit risk. Um, we will continue to, uh, to generate data. We will present some data as well, uh, on the durability. Um, but, uh, our goal is to get agreement on the dose, uh, and initiate this trial and, you know, with regards to, uh, partnership or, you know, initial, um, um, um, Pursuit is going to be to, to go ahead.

A launch is for ourselves. Uh, and you know, we did discussions, uh, I think we may remain open but we're pretty committed to moving this uh, forward um, by ourselves. And this study uh, will be launched by us.

Ziyi Chen: Got it. Thank you.

Operator: Thank you. Our next question comes from Li Watsek from Cantor. Please go ahead, Li.

Got it. Thank you.

Thank you.

Josh Smiley: Hey, good morning, guys. Thanks for taking our questions. I have two pipeline questions. First on Bema, just wondering what steps are left to file in China. Is it possible to get an NRDL listing in 2027, or should we assume it's more of a 2028 event? Then for DLL3 ADC, how are you guys thinking about the data from Hengrui, DLL3 program next month? Any reshoot your own program? For data update later this year, what additional information do you hope to share relative to the ASCO update? Thank you. Thanks, Lee. I think first on Bema, you know, Rafael can provide some more comments here, but our focus now is to, you know, get the file submitted and approved.

Li Watsek: Hey, good morning, guys. Thanks for taking our questions. I have two pipeline questions. First on Bema, just wondering what steps are left to file in China. Is it possible to get an NRDL listing in 2027, or should we assume it's more of a 2028 event? Then for DLL3 ADC, how are you guys thinking about the data from Hengrui, DLL3 program next month? Any reshoot your own program? For data update later this year, what additional information do you hope to share relative to the ASCO update? Thank you.

Our next question comes from Lee Watson from Cantor. Please go ahead, lie.

Uh hey, good morning guys. Thanks for taking our questions. I have 2 pipeline questions.

Uh, first on bema, um, just wondering what steps are left to file, uh, in China. Um, any is it possible to get an idea listing 2027, or should we assume it's more of a 2028 event?

Josh Smiley: Thanks, Lee. I think first on Bema, you know, Rafael can provide some more comments here, but our focus now is to, you know, get the file submitted and approved.You know, as you know, NRDL timing, you know, is dependent on when you're approved during the year, and that always changes and everything else. We're just focused right at this point on getting that product approved as quickly as possible and then moving as quickly as possible into NRDL listing. We'll have more to, you know, more to come there as we, as we move through the regulatory process. I think, Rafael, if you could jump in on both of the questions.

Um, and then for the office 3DC, um, how are you guys thinking about? Um, the data from Henry, um, dl3 uh, program, uh, next month, um, any reach to your on, uh, program and for data, um, update later this year, um, what additional information do you hope to share relative to the uh ASCO update. Thank you.

Josh Smiley: You know, as you know, NRDL timing, you know, is dependent on when you're approved during the year, and that always changes and everything else. We're just focused right at this point on getting that product approved as quickly as possible and then moving as quickly as possible into NRDL listing. We'll have more to, you know, more to come there as we, as we move through the regulatory process. I think, Rafael, if you could jump in on both of the questions.

Rafael Amado: Yeah. With regards to Bema, we have Breakthrough Therapy Designation, and we will be working with Amgen, our partner, in potential registration in China expeditiously. We obviously will have to do a pre-BLA meeting and get feedback from CDE. This is a priority for us. Again, we're in discussions with Amgen as to the initiation of the submission. With regards to the competition from Hengrui, yeah, we know, I think what everybody knows, which is that they're presenting ASCO later on next month.

Uh, jump in on both of the questions.

Uh yeah, so with regards to um to the email, we have breakthrough designation and uh we will um uh be working with amen. Our partner in uh potential uh registration in China expeditiously. Um we obviously will have to do a previously meeting and get feedback from CV. Uh and so um, um, this is a, a priority for us. Um, and again, we're in discussions with an engine.

As to, uh, the initiation of of, of the submission.

Rafael Amado: I would just only highlight the fact that products can, especially ADCs, can be differentiated by many factors, including the type of antibody, the epitope, the avidity, the payload, the linker, et cetera. We think that we have the best-in-class antibody as we showed at ASCO a couple of months ago with 79% response rate, which is yes, confirmed and unconfirmed, but among the highest that has ever been seen, and great activity in the brain as well. We are really advanced already with regards to getting the dose ready for execution of the phase three study, as I mentioned before.

Um, with regards to the company, the competition from Henry. Um, yeah, we, we know, um, I think what, what everybody knows which is that they're presenting a, a word long, um, later on, uh, uh next month. Um,

And I would just, uh, just only highlight the fact that, uh, you know, products that especially adcs can be differentiated by, um, you know, many factors including the type of antibodies, the epauto, the ability, the payload, the Linker, Etc. We think that we have the best in class to anybody as, uh, as as we showed at ASCO a couple of months ago with 79% uh, response rate which is um um yes confirm an unconfirmed. Uh, but among the highest I have uh ever been seen uh and great activity in the brain as well. Um uh and

Rafael Amado: We have, you know, a good time difference with regards to the competition. In terms of what we will present, there will be another four months worth of data, which will include updated response and time to event endpoints, both durability of response as well as progression-free survival. Importantly, we will also, we're characterizing these responses in the brain because they are really unprecedented, and it's something that we're hearing a lot from our investigators in terms of the high incidence and the durability.

Uh, uh, we are really, uh, Advanced already, uh, with regards to, um, you know, getting the dose, uh, uh, ready for, uh, execution of the F3 study, as I mentioned before. So, we have, um, you know, a good, uh, time, uh, um, the difference with regards to the competition, uh, and in terms of what we will present, that will be, uh, another 4 months worth of data, uh, which will include updated response. Uh, and

Rafael Amado: You will see run on, which is the way that brain metastases are assessed, as well as response for the brain metastases in the totality of the population. We may present some data on biomarker as well. I think the principal update will be updated responses on the dose optimization as well as durability.

Time to event, uh, end points both durability of response, as well as, uh, progression free survival. Uh, and importantly, um, we will also, we're characterizing these responses in the brain because, uh, they are really unprecedented and it's something that we're hearing a lot from from our investigators, um, uh, in terms of, uh, um, the the high incidence and the durability. Uh, so, um, we you will see, um, uh, run of which is, uh, the way that the brain metastasis is, as well as response, uh, for, uh, the brain metastases in the totality of the population, uh, and we may present some data on biomarker as well, but I think the principle, um, update will be updated responses uh, on the uh, toss optimization as well as durability.

Operator: All right. Thank you. We will now take our next question from the line of Jack Lin from Morgan Stanley. Please go ahead, Jack.

All right. Thank you.

Jack Lin: Hi. Thank you for taking my question. I have two brief questions. First one regarding the DLL3. I just would hope to, I think, clarify a bit on the catalyst with data timeline. If I could confirm again in terms of when we might expect the next data update from the second-line treatment, and especially I think on the expansion cohort. I think it was mentioned previously at the ASCO call, you know, we also have first line data upcoming. I'd just like to reconfirm on the timeline to expect for that.

We will now take our next question, from the line of Jack. Lin from Morgan Stanley. Please go ahead Jack.

Jack Lin: A second one, I think on, briefly on whether the company has review or update in terms of, you know, some of the policy news update regarding commercial insurance ramp up, and if there's any implications or changes to our commercial strategy for products like Optune. Just these two questions. Thank you.

Josh Smiley: Rafael, why don't you go ahead?

Rafael Amado: Yeah. For ZL-1310, we expect to provide this update before the end of the year on second line, as you mentioned. I explained before what the nature of the update will be. We had 89 patients at ASCO. Here we will have upwards of 110 patients, and obviously, 4 more months of follow-up, as I mentioned. With regards to first line, because, you know, we are prioritizing the second line study, we continue to enroll in the first line cohorts both with atezolizumab and carbo. If we have meaningful data, then perhaps it will be this year, but most likely it will be next year, early next year, that we will provide that information.

Hi. Uh, thank you for taking my question. I have a 2, uh, brief questions. First 1 regarding the T3, I just would hope to, I think clarify a bit on the, um, the Catalyst with data timeline. So, in fact to confirm again, in terms of when we might expect the next, um, data update from the second line treatment. And especially I think on the expansionary covert and also, I think it was mentioned previously at the Esco called. You know, we also have first sign data upcoming. I just like to reconfirm on the timeline to expect for that and the second 1, I think on a briefly on whether the company has any view or update in terms of, you know, some of the, the policy news update regarding the commercial insurance ramp up. And if there's any implications or um changes to our commercial strategy for products, like optune just these 2 questions. Thank you.

Yeah, why don't you go ahead? Yeah, so uh um for DL 31510 uh we expect to provide this update before the end of the year and the second line as you mentioned. Um, and and I, uh, explained before what the, the nature of the update will be, um,

Rafael Amado: We are spending time enrolling in the second line and standing up the phase 3 study. I hope this helps with the cadence of data. Just to mention that we are doing well on the neuroendocrine carcinoma, neuroendocrine tumors. These are distinct cohorts. We will provide an update as soon as we have meaningful information on that. So far the accrual has been very favorable. We think that it will be relatively quickly. We wanna wait until we see enough durability before we actually, you know, until that we can present a meaningful update.

Josh Smiley: Jack, I think on the commercial insurance policy changes, we're quite encouraged by the trend here. You know, keep in mind, I know you know this, you know, this, the reimbursement or funding for innovative drugs in China through a commercial insurance channel is considerably less than 10% today. I think as we look at the policy changes to try to drive that number higher, it certainly benefits us as we launch new innovative products, not just Optune or TTFields, but any of the products we've discussed today, there's always a lag between when they're approved through NMPA and when they are eligible for NRDL listing.

Uh, uh, the phase 3 study. Um, so um, so I hope this this helps with the the Cadence of, uh, of data. Um, and then just to mention that, uh, we are doing well on the neuroendocrine carcinoma or neuron tumors. These are distinct cohorts and um, um, we um, will provide an update as soon as we have uh meaningful information on that. But uh, so far the uh um, the approval has has has been very favorable. So we think that it will be uh relatively quickly. We want to wait until we see enough durability before we we actually you know uh uh until that we can present a meaningful aspect

Josh Smiley: I think that time period, as commercial insurance expands, gives us a really good opportunity, as we get drugs like Bema approved or KarXT or others to leverage these channels and drive good experience and sales in that stub period between approval and NRDL listing. I think that's important. Certainly, as it relates to Optune, and as we think about PANOVA or the opportunity in pancreatic cancer, I think that's one that we'll certainly be able to time that well with some of these policy changes.

And Jack, I think on the commercial insurance, um, policy changes. We're we're quite encouraged, uh, by the the trend here, you know, to keep in mind. I, I know, you know, this, um, you know, this, the, the, the reimbursement or funding for, Innovative drugs, in China, through a commercial insurance, uh, uh, channel is, is considerably less than 10%, uh, today. Um, so I think, as we, we look at the policy changes to try to drive that number, uh, higher. It, it certainly benefits us as, as we launch new Innovative products, not just, um, uh, optune or TT Fields, but any of the products we've discussed today, there's always a, a lag between when they're approved, uh, through nmpa. And when

Josh Smiley: Again, I think it's positive for all companies who are bringing innovative drugs to market in China, and we look forward to participating and taking advantage of that policy, those policy changes.

Rafael Amado: Got it. Thank you so much.

Jack Lin: Got it. Thank you so much.

They are eligible for an RDL listing. So I think that that, uh, time period. Um, as Commercial Insurance, um, expands uh, gives us a really good opportunity, uh, as we get uh, drugs, like bema approved or or car, XT or others, to leverage these channels and drive good experience in sales in that stub, period between approval and, uh, and, um, and our DL listing. So I think that's, that's important. Certainly as it relates to, um, to oportun. Uh, and as we think about, uh, pinova, or the opportunity in pancreatic cancer. I, I think that's 1 that we, we'll certainly be, um, able to time that well, with some of these policy changes. So, again, I think it's, I think it's positive for, uh, for all companies who are um, uh, bringing Innovative drugs uh to Market in in China and we look forward to participating and and taking advantage of that that uh that policy, those policy changes.

Operator: Great. Thank you. We have now come to the end of the question and answer session. Thank you all very much for your questions. I'd now like to turn the conference back to Dr. Samantha Du for her closing comments.

Got it. Thank you so much.

All right. Thank you.

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 Q3 2025. Operator, you may now disconnect this call.

We have now come to the end of the question and answer session. Thank you all very much for your questions. I now like to turn the conference back to Dr. Samantha do 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 you again after the third quarter of 2025.

Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect your lines.

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.

Q2 2025 Zai Lab Ltd Earnings Call

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