Q2 2023 Zai Lab Limited Earnings Call

Okay.

Operator: Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's Q2 2023 Financial Results Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at this time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Christine Chiou, Senior Vice President of Investor Relations. Please go ahead.

Operator: Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's Q2 2023 Financial Results Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at this time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Christine Chiou, Senior Vice President of Investor Relations. Please go ahead.

Speaker 1: Hello ladies and gentlemen, thank you for standing by and welcome to Zilab's second quarter 2023 financial results conference call.

Hello, Ladies and gentlemen, thank you for standing by and welcome to Xylem second quarter 2023 financial results Conference call.

Speaker 1: At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session. And instructions will follow at this time.

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

And instructions will follow at this time.

As a reminder, today's call is being recorded.

Speaker 1: It is now my pleasure to turn the floor over to Christine Cho, Senior Vice President of Ambassador Relations.

It is now my pleasure to turn the floor over to Christine Cho.

Senior Vice President of Investor Relations.

Christine Chiou: Thank you, operator. Good morning, good evening, and welcome to Zai Lab's Second Quarter 2023 Earnings Call. Today's 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 Oncology Research and Development, Dr. Harald Reinhart, President-

Christine Chiou: Thank you, operator. Good morning, good evening, and welcome to Zai Lab's Second Quarter 2023 Earnings Call. Today's 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 Oncology Research and Development, Dr. Harald Reinhart, President-

Please go ahead.

Speaker 2: Thank you, operator. Good morning. Good evening and welcome to Zilab's second quarter 2023 earnings.

Thank you operator, good morning, good evening and welcome to Bylaw <unk> second quarter 2023 earnings call today's call will be led by doctors, Samantha Du <unk> founder CEO and chair person. She will be joined by Josh Smiley, President and Chief operating officer, Dr. Rafael Amado, President and head of Glu.

Speaker 2: Today's call will be led by Dr. Samantha Du, Zilab's founder, CEO , and chair of.

Speaker 2: She will be joined by Josh Smiley, President and Chief Operating Officer, Dr. Rafael Motto, President and Head of Global Oncology Research and Development, Dr. Harold Reinhart.

Oncology research and development.

Josh Smiley: President and Head of Global Development, Neuroscience, Autoimmune, and Infectious Diseases, and 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 all 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 product revenue growth rates on a constant exchange rate basis, which is a non-GAAP financial measure. Please refer to our earnings release furnished with the SEC on 7 August 2023 for certain disclosures regarding this non-GAAP financial measure. At this time, it is my pleasure to turn the call over to Dr.

Christine Chiou: President and Head of Global Development, Neuroscience, Autoimmune, and Infectious Diseases, and 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 all 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 product revenue growth rates on a constant exchange rate basis, which is a non-GAAP financial measure. Please refer to our earnings release furnished with the SEC on 7 August 2023 for certain disclosures regarding this non-GAAP financial measure. At this time, it is my pleasure to turn the call over to Dr.

Or how old Reinhart.

Speaker 2: President and Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases, and Dr. Yajin Chen, Chief Financial Officer.

Evidence and head of global development, neuroscience, autoimmune and infectious diseases and Dr. <unk> Chang Chief Financial Officer.

Speaker 2: Jonathan Wang, our Chief Business Officer, will also be available to answer questions during the Q&A portion of the call.

Jonathan Wang our Chief business Officer will also be available to answer questions. During the Q&A portion of the call.

Speaker 2: As a reminder, during today's call, we will all be making certain forward-looking statements based on our current expectations.

As a reminder, during today's call we will all be making certain forward looking statements based on our current expectations.

Speaker 2: 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 filing.

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.

Speaker 2: We will also refer to product revenue growth rates on a constant exchange rate basis, which is a non-GAAP financial measure.

We will also refer to product revenue growth rates on a constant exchange rate basis, which is a non-GAAP financial measure.

Speaker 2: Please refer to our earnings release furnished with the SEC on August 7, 2023, for certain disclosures regarding this non-GAAP funding.

Please refer to our earnings release furnished with the SEC on August seven 2023 for certain disclosures regarding this non-GAAP financial measure.

Speaker 2: At this time, it is my pleasure to turn the call over to Dr. Samantha.

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

Josh Smiley: Samantha Du.

Christine Chiou: Samantha Du.

Samantha Du: Thank you, Christine. Hello, everyone. Thank you all for joining us today. In Q2 2023, we continued to successfully execute across our business, achieving multiple key milestones. Our commercial products continue to deliver strong double-digit growth. We progressed several important late stage and early development programs within our pipeline. Most importantly, we gained NMPA approval of VYVGART, a first-in-class therapy that has the potential to significantly transform the lives of patients living with gMG in China. We were able to achieve this monumental milestone on 30 June, which makes us eligible for NRDL listing in 2024. Recently, we also had positive registrational data from the ADHERE trial evaluating VYVGART Hytrulo in CIDP, and the results were outstanding. Later this year, we anticipate two additional registrational data readouts for VYVGART, further supporting its potential as a blockbuster product.

Samantha Du: Thank you, Christine. Hello, everyone. Thank you all for joining us today. In Q2 2023, we continued to successfully execute across our business, achieving multiple key milestones. Our commercial products continue to deliver strong double-digit growth. We progressed several important late stage and early development programs within our pipeline. Most importantly, we gained NMPA approval of VYVGART, a first-in-class therapy that has the potential to significantly transform the lives of patients living with gMG in China. We were able to achieve this monumental milestone on 30 June, which makes us eligible for NRDL listing in 2024. Recently, we also had positive registrational data from the ADHERE trial evaluating VYVGART Hytrulo in CIDP, and the results were outstanding. Later this year, we anticipate two additional registrational data readouts for VYVGART, further supporting its potential as a blockbuster product.

Speaker 3: Thank you, Christine. Hello, everyone. Thank you all for joining us today. In a second quarter of 2023, we continue.

Thank you Christine.

Hello, everyone. Thank.

Thank you all for joining us today.

In the second quarter of 'twenty three.

We continue to successfully execute.

Across our business.

Multiple key milestones.

Speaker 2: Our commercial products continue to deliver strong double digit...

Our commercial products continue to deliver strong double digit growth.

Speaker 2: We progress several important day stage and early development programs within our

We progressed several important late stage and early development programs within our platform.

Okay.

Speaker 2: Most importantly, we gained NMP approval of this grant.

Most importantly, the King and then P approval of this car.

Speaker 2: forcing class therapy that has the potential to significantly transform the lives of patients living with J&J in China.

Our first in class therapy that has the potential to significantly transformed the lives of patients living with TNT in China.

Speaker 2: and we were able to achieve this monumental milestone on June 3rd.

And we were able to achieve a monumental milestone on from surface.

Speaker 2: makes us eligible for NRDR listing in 2024.

Makes us eligible for an archaeologist between 'twenty 'twenty four.

Speaker 2: Recently, we also had positive registration data from the HEAL trial.

Recently, we also had tough registrational data from the heat trial.

Speaker 2: evaluating Viscar-Hajulo in CIDP, and the results were outstanding.

Evaluating these cause actual E C O P P and the result of Dundee.

Later this year.

Speaker 2: we anticipate two additional registration of data results for VSCAR, further supporting its potential as a blockbuster product. The NMP's approval of VSCAR exemplifies our ability to quickly develop novel...

Two additional registrational data readouts obese clock.

Further supporting potential as a blockbuster product.

Samantha Du: The NMPA approval of VYVGART exemplifies our ability to quickly develop novel first-in-class therapies addressing significant unmet needs of patients. Today, we have over 17 pivotal trials ongoing. By 2028, we expect to more than triple the number of commercial products in our portfolio. Our world-class R&D team is a key part of our success, driving our remarkable accomplishments, consistently demonstrating an impeccable ability to identify and develop drugs of global quality. This impressive track record instills in us the confidence to bolster our global pipeline, both organically and collaboratively. In our early research efforts, we continue to pursue targets and modalities within specific areas of oncology and autoimmune disorders. We are focused in areas where there is opportunity for differentiation, where the unmet needs are high.

Samantha Du: The NMPA approval of VYVGART exemplifies our ability to quickly develop novel first-in-class therapies addressing significant unmet needs of patients. Today, we have over 17 pivotal trials ongoing. By 2028, we expect to more than triple the number of commercial products in our portfolio. Our world-class R&D team is a key part of our success, driving our remarkable accomplishments, consistently demonstrating an impeccable ability to identify and develop drugs of global quality. This impressive track record instills in us the confidence to bolster our global pipeline, both organically and collaboratively. In our early research efforts, we continue to pursue targets and modalities within specific areas of oncology and autoimmune disorders. We are focused in areas where there is opportunity for differentiation, where the unmet needs are high.

Okay, and then P cobalt Oh God.

75000 billing so.

So quickly develop novel first in class therapy.

We're seeing significant unmet needs for patients.

Speaker 2: And today, we have over 17 pivotal trials on board. And by 2028, we expect to more than triple the number of commercial products in our portfolio.

And today, we have over 17 pivotal trials I'm going by.

But 28, we expect to more than triple the number of commercial products and all told 40.

Speaker 2: Our world-class R&D team is a key part of our success, driving our remarkable accomplishments consistently.

Our World Class R&D team is a key part of our success.

Dragging lava remarkable accomplishments.

Consistently demonstrating peccable ability.

Speaker 2: to identify and develop drugs of global quality.

To identify and develop trucks of global quality.

Speaker 2: This impressive track record instills in us the confidence to bolster our global pipeline, both organically and collaboratively.

This impressive track record is still giving us the confidence to bolster our global pipeline.

Both organically and corporate type thing.

Speaker 2: In our early research efforts, we continued to pursue targets and modalities within specific areas of ecology and autoimmune disorder.

In our early research at first.

We continue to pursue targets and modalities.

In specific areas of oncology and autoimmune disorders.

Speaker 2: We're focusing areas where there is opportunity for differentiation. Where the unmet needs are high. However, make no mistake. We'll continue to be...

Our full Christine terrorists.

There is opportunity for differentiation.

Unmet needs are high.

Samantha Du: However, make no mistake, we'll continue to be prudent and capital efficient, prioritizing our R&D efforts and driving increased productivity across the organization by leveraging our existing infrastructure and creating synergies across our business. We expect that this discipline, along with our expected revenue growth, will allow us to reach corporate profitability by the end of 2025. I'm also encouraged by the continued support of innovation within the life science industry in China, as evidenced by the recently published NRDL renewal guidelines and other policy updates. I'm confident that with our world-class team and the strong foundation we have built, we will be able to reach new heights, driven by our unwavering commitment to bring innovative medicines to patients in need with Zai's speed, quality, and efficiency, and bring significant value to our shareholders as we deliver on our mission.

Samantha Du: However, make no mistake, we'll continue to be prudent and capital efficient, prioritizing our R&D efforts and driving increased productivity across the organization by leveraging our existing infrastructure and creating synergies across our business. We expect that this discipline, along with our expected revenue growth, will allow us to reach corporate profitability by the end of 2025. I'm also encouraged by the continued support of innovation within the life science industry in China, as evidenced by the recently published NRDL renewal guidelines and other policy updates. I'm confident that with our world-class team and the strong foundation we have built, we will be able to reach new heights, driven by our unwavering commitment to bring innovative medicines to patients in need with Zai's speed, quality, and efficiency, and bring significant value to our shareholders as we deliver on our mission.

However, make no mistake, we will continue to be prudent on capital efficient.

Prioritizing our R&D efforts.

Speaker 2: driving increased productivity across the organization by leveraging our existing infrastructure and creating symmetries.

<unk> increased productivity across the organization by leveraging our existing infrastructure and creating synergies across our business.

Speaker 2: We expect that this discipline along with our expected when you.

We expect that this discipline.

Along with our expected revenue growth.

Speaker 2: will allow us to reach corporate profitability by the end of 2025.

We are allowing us to reach corporate profitability by the end of 'twenty can do fine.

Speaker 2: I'm also encouraged by the continued support of innovation within the life science industry.

I'm also encouraged by the continued support of innovation within the life science industry in China.

Speaker 2: Has evidence that it recently published and our renewal guidelines and other policy updates. I'm confident that with our work class team. And the strong foundation.

As evidenced by the recently published <unk>.

D all renewable guidelines and other policy updates.

I'm confident that with our world class team.

Strong foundation, we have built.

We'll be able to reach new highs.

Speaker 2: Given by our unwavering commitment to bring innovative medicines to patients in need, with size, speed, quality, and efficiency, it brings significant value to our shareholders as we deliver on our mission.

Kevin.

Wavering commitment to bringing innovative medicines to patients who need the site speed quality.

You can see.

Significant value to our shareholders as we deliver on our mission.

Samantha Du: With that, I would like to now turn the call over to Josh. Josh?

Samantha Du: With that, I would like to now turn the call over to Josh. Josh?

Speaker 2: And with that, I'll let them now turn the call over to Josh.shotsgun just deploying at Honeywell State University computer science feeder is now tv

And with that I'll, let him I'll turn the call over to Josh Josh.

Josh Smiley: Thank you, Samantha. As Samantha mentioned, because of the proactive steps taken by our team, Zai Lab has established a good foundation for future commercial execution and strong financial performance. Product revenues in Q2 2023 grew 45% year over year to $69 million. This revenue growth was 53% on a constant currency basis. Each of our commercial products had continued revenue growth. Kyprolis and Xyriv experienced strong volume uptake as a result of their listings on the National Reimbursement Drug List or NRDL, which became effective in March. We expect the successful NRDL inclusions will continue to drive significant sales growth for these two products in the remaining months of 2023 and beyond.

Josh Smiley: Thank you, Samantha. As Samantha mentioned, because of the proactive steps taken by our team, Zai Lab has established a good foundation for future commercial execution and strong financial performance. Product revenues in Q2 2023 grew 45% year over year to $69 million. This revenue growth was 53% on a constant currency basis. Each of our commercial products had continued revenue growth. Kyprolis and Xyriv experienced strong volume uptake as a result of their listings on the National Reimbursement Drug List or NRDL, which became effective in March. We expect the successful NRDL inclusions will continue to drive significant sales growth for these two products in the remaining months of 2023 and beyond.

Speaker 4: Thank you, Samantha. As Samantha mentioned, because of the proactive steps taken by our...

Thank you Samantha as Samantha mentioned because of the proactive steps taken by our team XI Lab has established a good foundation for future commercial execution and strong financial performance.

Speaker 4: Xylab has established a good foundation for future commercial execution and strong financial performance.

Speaker 4: Product revenues in the second quarter of 2023 grew 45% years prior to $69 million. This revenue growth was 53% on a constant currency basis.

Product revenues in the second quarter of 2023 grew 45% to $69 million. This revenue growth was 53% on a constant currency basis.

Each of our commercial products that continued revenue growth.

Speaker 4: The SIRA experienced strong volume uptake as a result of their listings on the National Reimbursement Drug List, or NRDL, which became effective in March. We expect that successful NRDL inclusions will continue to drive significant sales growth for these two products in the remaining months of 2023 and 2021.

IRA experienced strong volume uptake as a result of their listings on the national reimbursement drug list or NR deal, which became effective in March we expect the successful <unk> inclusions will continue to drive significant sales growth for these two products in the remaining months of 2023 and beyond.

Josh Smiley: ZEJULA continued to perform well, increasing 26% versus prior year quarter, driven by growth in the sales of PARP inhibitors in ovarian cancer and ZEJULA's increased share of those sales. For Optune, our team further improved market access by expanding supplemental insurance coverage. We expect this strong momentum for both products to continue throughout the remainder of this year. We're also very excited to be launching our fifth approved product later this year, following the NMPA's approval of VYVGART as the first and only FcRn blocker to treat generalized myasthenia gravis or gMG in China. There are nearly 150,000 patients in China who have acetylcholine receptor antibody positive gMG, and we are thrilled to be able to provide these patients with a new treatment option that has the potential to meaningfully improve their symptoms and subsequently have a positive effect on their quality of life.

Josh Smiley: ZEJULA continued to perform well, increasing 26% versus prior year quarter, driven by growth in the sales of PARP inhibitors in ovarian cancer and ZEJULA's increased share of those sales. For Optune, our team further improved market access by expanding supplemental insurance coverage. We expect this strong momentum for both products to continue throughout the remainder of this year. We're also very excited to be launching our fifth approved product later this year, following the NMPA's approval of VYVGART as the first and only FcRn blocker to treat generalized myasthenia gravis or gMG in China. There are nearly 150,000 patients in China who have acetylcholine receptor antibody positive gMG, and we are thrilled to be able to provide these patients with a new treatment option that has the potential to meaningfully improve their symptoms and subsequently have a positive effect on their quality of life.

Speaker 4: Zajula continued to perform well, increasing 26% versus prior year, a quarter driven by growth in the sales of PARP inhibitors in ovarian cancer and Zajula's increase in increased by a quarter driven by growth in the sales of PARP inhibitors in ovarian cancer

<unk> continued to perform well, increasing 26% versus prior year quarter driven by growth in the sales of PARP inhibitors in ovarian cancer and the jewel is increased share of those sales.

Speaker 4: For Optune, our team further improved market access by expanding supplemental...

Barack tune our team further improved market access by expanding supplemental insurance coverage.

Speaker 4: We expect a strong momentum for both products to continue throughout the remainder of this year. We're also very excited to be...

We expect the strong momentum for both products to continue throughout the remainder of this year.

We're also very excited to be launching our fifth approved product later this year. Following the <unk> approval of Bib guard at the first and only SCR and blocker to treat generalized myasthenia gravis or gmg in China. There are nearly 150000 patients in China, who have asked the choline receptor antibody positive.

Speaker 4: following the NMPA's approval of BivGuard as the first and only FCRN blocker to treat generalized myasthenia gravis or GMG in China.

Speaker 4: There are nearly 150,000 patients in China who have ostacoline receptor antibody positive GM.

Speaker 4: we are thrilled to be able to provide these patients with a new treatment option that has the potential to meaningfully improve their symptoms and subsequently have a positive effect on their quality of life.

Gmg and we are thrilled to be able to provide these patients with a new treatment option that has the potential to meaningfully improve their symptoms and subsequently have a positive effect on their quality of life or.

Josh Smiley: Our specialized and experienced team of about 100 employees in the field are already engaging key opinion leaders and healthcare professionals and are establishing a strong network across all sites of care. We are building brand awareness through activities that include broad-reaching campaigns and through our ongoing named patient program, which is generating initial clinical data among Chinese patients. VYVGART, which is eligible for NRDL listing in 2024, will be our fourth product on the list, and we are ready for a full commercial launch later this year. Moreover, another significant milestone we achieved with VYVGART was the positive results from the registrational ADHERE study in CIDP. The safety and efficacy profile of VYVGART represents a significant advancement for patients, one that has the potential to change the treatment paradigm for those living with CIDP.

Josh Smiley: Our specialized and experienced team of about 100 employees in the field are already engaging key opinion leaders and healthcare professionals and are establishing a strong network across all sites of care. We are building brand awareness through activities that include broad-reaching campaigns and through our ongoing named patient program, which is generating initial clinical data among Chinese patients. VYVGART, which is eligible for NRDL listing in 2024, will be our fourth product on the list, and we are ready for a full commercial launch later this year. Moreover, another significant milestone we achieved with VYVGART was the positive results from the registrational ADHERE study in CIDP. The safety and efficacy profile of VYVGART represents a significant advancement for patients, one that has the potential to change the treatment paradigm for those living with CIDP.

Speaker 4: Our specialized and experienced team of about 100 employees in the field are already

Our specialized and experienced team of about 100 employees in the field are already engaging key opinion leaders and health care professionals and are establishing a strong network across all sites of care we.

Speaker 4: and healthcare professionals, and are establishing a strong network across all...

Speaker 4: We're building brand awareness through activities and include broad reaching campaigns and through our ongoing name-to-patient program, which is generating initial clinical data among Chinese.

We are building brand awareness through activities and include broad reaching campaigns and through our ongoing named patient program, which is generating initial clinical data among Chinese patients.

Speaker 4: VivGuard, which is eligible for NRDL listing in 2024, would be our fourth product on the list. And we are ready for a full commercial launch later.

They've guard, which is eligible for NRG lifting in 2024 will be our fourth product on the list and we are ready for a full commercial launch later this year.

Speaker 4: Moreover, another significant milestone we achieved with DIVGART was the positive results from the registrational adhere study in CIT.

Moreover, another significant milestone we achieved with depth guard with the positive results from the Registrational study in CIBC.

Speaker 4: safety and efficacy profile of VivGARC represents a significant advantage.

The safety and efficacy profile of <unk> represents a significant advancement for patients one that has the potential to change the treatment paradigm for those living with CIBC.

Speaker 4: One that has the potential to change the treatment paradigm for those living

Josh Smiley: Similar to the ADHERE study, Zai is also participating in two registrational studies evaluating VYVGART in pemphigus and immune thrombocytopenia, where we expect data later this year. In these four indications alone, we have a total addressable population of over 400,000 patients, highlighting the significant opportunity we have with this product. Over the next few years, we expect to further drive innovation through our expertise in research and development. We intend to do this both as a trusted partner with our demonstrated capabilities in contributing to global, high-quality, multi-center trials and through the successful execution of trials for our own assets with global rights. The strong foundation we have built puts us in an excellent position to execute our five-year strategic plan, which we announced at our Investor Day.

Josh Smiley: Similar to the ADHERE study, Zai is also participating in two registrational studies evaluating VYVGART in pemphigus and immune thrombocytopenia, where we expect data later this year. In these four indications alone, we have a total addressable population of over 400,000 patients, highlighting the significant opportunity we have with this product. Over the next few years, we expect to further drive innovation through our expertise in research and development. We intend to do this both as a trusted partner with our demonstrated capabilities in contributing to global, high-quality, multi-center trials and through the successful execution of trials for our own assets with global rights. The strong foundation we have built puts us in an excellent position to execute our five-year strategic plan, which we announced at our Investor Day.

Speaker 4: Similar to the adheres study, Zai is also participating in two Registrational Studies evaluating VibGuard in Pemphagus and Immune thrombocytopenia, where we expect data later to...

Similar to the adhere study <unk> also participating in two Registrational studies evaluating zipcard in Tampa and immune thrombocytopenia, where we expect data later this year.

Speaker 4: In these four indications alone, we have a total addressable population of over 400,000.

In these four indications alone we have a total addressable population of over 400000 patients highlighting the significant opportunity we have with this product over the next few years, we expect to further drive innovation through our expertise in research and development.

Speaker 4: highlighting the significant opportunity we have with this product. Over the next few years, we expect to further drive innovation through our expertise in research and development.

Speaker 4: We intend to do this both as a trusted partner with our demonstrated capabilities in contributing to global, high quality, multi-center trials, and through the successful execution of trials for our own assets with global rights.

We intend to do this both as a trusted partner with our demonstrated capabilities and contributing to global high quality multi center trials and through the successful execution of trials for our own assets with global rights.

Speaker 4: The strong foundation we have built puts us in an excellent position to execute our five year strategic plan.

The strong foundation, we have built puts us in an excellent position to execute our five year strategic plan, which we announced at our Investor day.

Josh Smiley: By the end of 2028, we expect to have over 15 commercial-stage products with at least one IND per year for global best-in-class, first-in-class assets. Our robust portfolio is expected to drive a revenue compound annual growth rate of over 50% from 2023 to 2028. As we launch new products and indications, we'll be able to leverage our infrastructure and scale to drive profitability. We expect to be commercially profitable by the end of 2023 and to achieve corporate profitability by the end of 2025. Now I will turn the call over to Dr. Amado. Rafael?

Josh Smiley: By the end of 2028, we expect to have over 15 commercial-stage products with at least one IND per year for global best-in-class, first-in-class assets. Our robust portfolio is expected to drive a revenue compound annual growth rate of over 50% from 2023 to 2028. As we launch new products and indications, we'll be able to leverage our infrastructure and scale to drive profitability. We expect to be commercially profitable by the end of 2023 and to achieve corporate profitability by the end of 2025. Now I will turn the call over to Dr. Amado. Rafael?

Speaker 4: By the end of 2028, we expect to have over 15 commercial stage products, with at least one IND per year for global Vestin Class, Versin Class A.

By the end of 2028, we expect to have over 15 commercial stage products with at least one IND per year for global best in class first in class assets.

Speaker 4: Our robust portfolio is expected to drive a revenue compound annual growth rate of over 50% from 2023 to 2028.

Our robust portfolio is expected to drive a revenue compound annual growth rate of over 50% from 2023 to 2028.

Speaker 4: As we launch new products and indications, we'll be able to leverage our infrastructure and scale to drive profitability.

As we launch new products and indications, we will be able to leverage our infrastructure and scale to drive profitability and we expect to be commercially profitable by the end of 2023 and to achieve corporate profitability by the end of 2025.

Speaker 4: and we expect to be commercially profitable by the end of 2023, and to achieve corporate profitability by the end of 2025.

And now I will turn the call over to Dr. Mato Raphael.

Rafael Amado: Thank you, Josh. In Q2 2023, Zai Lab's oncology franchise continued to make progress across all stages of development. Within oncology, our R&D team will remain sharply focused on the execution of our late-stage product development, and we expect several important updates from some of our key programs over the next 6 to 12 months. Starting with repotrectinib in June, we announced that the National Medical Products Administration in China has accepted a new drug application for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer after granting priority review in May 2023. Repotrectinib is a potential next-generation best-in-class treatment for ROS1-positive non-small cell lung cancer in both TKI naive and pretreated patients. We look forward to bringing this important medicine to patients in need as early as possible.

Rafael Amado: Thank you, Josh. In Q2 2023, Zai Lab's oncology franchise continued to make progress across all stages of development. Within oncology, our R&D team will remain sharply focused on the execution of our late-stage product development, and we expect several important updates from some of our key programs over the next 6 to 12 months. Starting with repotrectinib in June, we announced that the National Medical Products Administration in China has accepted a new drug application for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer after granting priority review in May 2023. Repotrectinib is a potential next-generation best-in-class treatment for ROS1-positive non-small cell lung cancer in both TKI naive and pretreated patients. We look forward to bringing this important medicine to patients in need as early as possible.

Speaker 5: Thank you, Josh in the second quarter of 2023, Xilab's oncology franchise continue to make progress across all stages of development. Within oncology, our R&D team will remain properly focused on the execution of our late-stage product development, and we expect several important updates from some of our key programs over the next 6 to 12 months.

Thank you Josh in the second quarter of 2023 dial up some quality franchise continued to make progress across all stages of development within oncology R&D team will remain sharply focused on the execution of our late stage product development and we expect several important updates from some of our key programs over the next six.

Two to 12 months.

Speaker 5: Starting with Repotectinib in June , we announced that the National Medical Products Administration in China has accepted a new drug application for the treatment of adult patients with locally advanced or metastatic ROS1 positive non-small cell lung cancer after granting priority review in May 2020. I still don't know what this is yet, but, regarding Ch minimalist

Starting with <unk> effective in June we announced that the National Medical products Administration, China has accepted our new drug application for the treatment of adult patients with locally advanced or metastatic <unk> positive non small cell lung cancer. After granting priority review in May 2023 April .

Speaker 5: People tracking every type of potential next generation best in class treatment for Rosh 1 positive non-smost among cancer in both TKI naive and pre-treated patients.

<unk>, maybe just have potential next generation best in class treatment for Russ one positive non small cell lung cancer in both Teekay <unk> nave and pretreated patients. We look forward to bringing this important medicine to patients in need as early as possible.

Speaker 5: We look forward to bringing this important medicine to patients in need as early as possible.

Rafael Amado: For Tumor Treating Fields, in June, our partner, Novocure, presented the full results of the LUNAR clinical trial evaluating TTFields in non-small cell lung cancer. The primary endpoint of median overall survival was met, and a meaningful overall benefit was demonstrated when TTFields therapy was added to immune checkpoint inhibitors with a median overall survival of 18.5 months versus ICI alone of 10.8 months. TTFields therapy was well-tolerated with no added systemic toxicities. We're also participating in several other pivotal trials, including METIS in brain metastasis from lung cancer, as well as PANOVA-3 in locally advanced pancreatic cancer, and look forward to these data readouts over the next year.

Rafael Amado: For Tumor Treating Fields, in June, our partner, Novocure, presented the full results of the LUNAR clinical trial evaluating TTFields in non-small cell lung cancer. The primary endpoint of median overall survival was met, and a meaningful overall benefit was demonstrated when TTFields therapy was added to immune checkpoint inhibitors with a median overall survival of 18.5 months versus ICI alone of 10.8 months. TTFields therapy was well-tolerated with no added systemic toxicities. We're also participating in several other pivotal trials, including METIS in brain metastasis from lung cancer, as well as PANOVA-3 in locally advanced pancreatic cancer, and look forward to these data readouts over the next year.

Speaker 5: For tumor-treating fields, in June , our partner, Novocure, presented the full results of the Luna's Ventus trial evaluating PT fields in non-smoke-sabon camp.

For tumor treating fields in June our partner Novocure presented the full results of the doughnut clinical trial evaluating <unk> in non small cell lung cancer.

Speaker 5: The primary endpoint of median overall survival was met and a meaningful overall benefit was demonstrated when T-Tixwell therapy was added to immune checkpoint inhibitors with a median overall survival of 18.5 months versus ICI alone of 10.8 months.

Primary endpoint of median overall survival with med.

Meaningful overall benefit was demonstrated when T cell therapy with the added to immune checkpoint inhibitors with a median overall survival of $18 five months versus ICI alone of $10 eight months.

Speaker 5: DPCO therapy was well tolerated with no added systemic.

You can feel therapy was well tolerated with no systemic toxicity.

Speaker 5: but also participating in several other pivotal trials, including matches, in-brain metastasis from lung cancer, as well as panobasturi in locally advanced pancreatic cancer, and look forward to these data readouts over the next year.

We're also participating in several of our other pivotal trials, including Metis in brain metastases from lung cancer as well as Panama City in locally advanced pancreatic cancer and look forward to these data readouts over the next year.

Rafael Amado: For bemarituzumab, Zai Lab enrolled the first patient in the mainland China portion of the global Phase 3 FORTITUDE-101 study, which was initiated by our partner Amgen and is evaluating bemarituzumab plus chemotherapy versus placebo plus chemotherapy in first-line gastric cancer with FGFR2b overexpression. Gastric cancer is a significant burden in China, where nearly 90% of patients are HER2-negative patients, and of those, about 30% are FGFR2b positive. Bemarituzumab has the potential to become the standard of care as a first-line treatment for FGFR2b-positive gastric cancer, where no specific targeted therapies exist to date. For adagrasib, we're on track to finish accrual this year on the KRYSTAL-12 trial against docetaxel and have completed the second-line CRC study KRYSTAL-10, which will form the basis for the submissions in these indications together with the global single-arm study.

Rafael Amado: For bemarituzumab, Zai Lab enrolled the first patient in the mainland China portion of the global Phase 3 FORTITUDE-101 study, which was initiated by our partner Amgen and is evaluating bemarituzumab plus chemotherapy versus placebo plus chemotherapy in first-line gastric cancer with FGFR2b overexpression. Gastric cancer is a significant burden in China, where nearly 90% of patients are HER2-negative patients, and of those, about 30% are FGFR2b positive. Bemarituzumab has the potential to become the standard of care as a first-line treatment for FGFR2b-positive gastric cancer, where no specific targeted therapies exist to date. For adagrasib, we're on track to finish accrual this year on the KRYSTAL-12 trial against docetaxel and have completed the second-line CRC study KRYSTAL-10, which will form the basis for the submissions in these indications together with the global single-arm study.

Speaker 5: For Benmarituzumab, Zai Lab enrolled the first patient in the mainland China portion of the global Phase III Fortitude 101 study, which was initiated by our partner Amgen, and is evaluating Benmarituzumab plus chemotherapy versus placebo plus chemotherapy in first-line gastric cancer with STFR2B overexpression.

Programmatic just in that side.

<unk> enrolled the first patient in the mainland China portion of the global Phase III project to 101 study, which was initiated by our partner Amgen and is evaluating <unk> plus chemotherapy versus placebo plus chemotherapy in first line gastric cancer with <unk> over expression Cascade.

Speaker 5: Gastic cancer is a significant burden in China where nearly 90% of patients are HER2 negative patients. And of those, about 30% are FTFR2B.

<unk> cancer is a significant burden in China were nearly 90% of patients that hurt too negative patient and of those about 30% <unk> to be positive.

Speaker 5: The marigisima has the potential to become the standard of care as a first line treatment for Fgfr2b positive gastric cancer where no specific targeted therapies exist today.

And that has the potential to become the standard of care as a first line treatment for <unk> positive gastric cancer, we're not specific targeted therapeutics to date.

Speaker 5: For our aggressive, we're on track to finish accrual this year on the K-12 trial against Docetaxel and have completed the second line CRC study K-10, which will form the basis for the submissions in these indications together with the global single-arm study.

Put out aggressive we're on track to finish accrual this year on the K 12 trial against Docetaxel and have completed the second line CRC study 10, which will form the basis for the submission in these indications together with the global single arm study.

Rafael Amado: For tisotumab vedotin, we also remain on track executing on the randomized study in cervical cancer, and we will also join the global study in squamous cell carcinoma of the head and neck, both also pivotal for registration in these indications in the Greater China region. Moving to our internal global research and development programs, in July 2023, we enrolled the first patient in the global phase 1 study for ZL-1218, an anti-CCR8 antibody in solid tumors in the United States. Regarding our DLL3 ADC, ZL-1310, we remain on track and expect an IND submission by the end of the year. With many potential best-in-class and first-in-class products both in China and globally, we are very excited about our expanding oncology pipeline at Zai Lab. Now I will turn the floor over to Dr.

Rafael Amado: For tisotumab vedotin, we also remain on track executing on the randomized study in cervical cancer, and we will also join the global study in squamous cell carcinoma of the head and neck, both also pivotal for registration in these indications in the Greater China region. Moving to our internal global research and development programs, in July 2023, we enrolled the first patient in the global phase 1 study for ZL-1218, an anti-CCR8 antibody in solid tumors in the United States. Regarding our DLL3 ADC, ZL-1310, we remain on track and expect an IND submission by the end of the year. With many potential best-in-class and first-in-class products both in China and globally, we are very excited about our expanding oncology pipeline at Zai Lab. Now I will turn the floor over to Dr.

Speaker 5: For T-STAC, we also remain on track, executing on the randomized study in cervical cancer, and we will also join the global study in squamous cell carcinoma of the head and neck, but also pivotal for registration in these indications in the greater channel.

For <unk>, we also remain on track executing on the randomized study in cervical cancer and we will also joined the global study in squamous cell carcinoma of the head and neck, but also pivotal for registration in this indication in the greater China region.

Speaker 5: Moving to an internal global research and development program in July 2023, we enroll the first patient in the global phase one study for ZL-1218, an anti-CCR-AID antibody in solid tumors in the United States.

Moving to an internal goal of research and development programs in July 2023 win grow the first patient in the global Phase One study for <unk> 2018, and anti <unk> eight antibody in solid tumors in the United States.

Speaker 5: Regarding our DLC, ADC, ZL 1310, we remain on track and expect an IND submission by the end of the year.

Regarding our idea of the ADC <unk> 10, we remain on track and expect an IND submission by the end of the year.

Speaker 5: With many potential best in class and first in class products, both in Canada and globally, we are very excited about our expanding oncology pipeline as I laugh. And now I will turn the floor over to Dr. Harald Rainhard to discuss the progress in up to a million infectious diseases and neuroscience therapeutic areas. Harald. Thank you.

With many potential best in class and first in class product, both in China and globally. We're very excited about our expanding oncology pipeline, a very loud and now I will turn the floor over to Dr. Harald Reinhart to discuss the progress in auto immune infectious diseases and neuroscience therapeutic area.

Rafael Amado: Harald Reinhart to discuss the progress in autoimmune, infectious diseases, and neuroscience therapeutic areas. Harald?

Rafael Amado: Harald Reinhart to discuss the progress in autoimmune, infectious diseases, and neuroscience therapeutic areas. Harald?

Harald Reinhart: Yeah. Thank you, Rafael. We have made excellent progress across our autoimmune infectious disease and neuroscience therapeutic areas. Starting with VYVGART or efgartigimod, we had several significant achievements in Q2. In June, we received NMPA approval for VYVGART intravenous injection for the treatment of generalized myasthenia gravis or gMG in adult patients who are acetylcholine receptor antibody positive. gMG is a chronic debilitating disease characterized by a loss of muscle function and severe muscle weakness. In China, patients are often treated with acetylcholinesterase inhibitors, steroids, immunosuppressants, and IVIG, and acetylcholinesterase inhibitors and steroids are used as initial therapies. The current available treatments for gMG have limited efficacy and are associated with significant side effects. With the high prevalence of these diseases, coupled with the current unsatisfactory treatment options, patients are in urgent need of a safe and effective treatment option that can control symptoms faster.

Harald Reinhart: Yeah. Thank you, Rafael. We have made excellent progress across our autoimmune infectious disease and neuroscience therapeutic areas. Starting with VYVGART or efgartigimod, we had several significant achievements in Q2. In June, we received NMPA approval for VYVGART intravenous injection for the treatment of generalized myasthenia gravis or gMG in adult patients who are acetylcholine receptor antibody positive. gMG is a chronic debilitating disease characterized by a loss of muscle function and severe muscle weakness. In China, patients are often treated with acetylcholinesterase inhibitors, steroids, immunosuppressants, and IVIG, and acetylcholinesterase inhibitors and steroids are used as initial therapies. The current available treatments for gMG have limited efficacy and are associated with significant side effects. With the high prevalence of these diseases, coupled with the current unsatisfactory treatment options, patients are in urgent need of a safe and effective treatment option that can control symptoms faster.

<unk>.

Yes, Thank you Rafa.

Speaker 6: We have made excellent progress across our autoimmune infectious disease and neuroscience therapeutic areas.

We have made excellent progress across our autoimmune infectious disease at neuroscience therapeutic areas.

Speaker 6: Starting with VifGuard, or if get TIGIMOD, we had several significant achievements in the...

Starting with Lyft correct.

Demand, we had several significant achievements in the second quarter.

Speaker 6: In June , we received an NMPI prophylaxis intervenous injection for the treatment of T. myosinib gravis, which we enjoy.

In June we received an NPA approved previous got intravenous injection for the treatment of generalized myasthenia gravis with gmg.

Speaker 6: in and out patients who are acetylcholine receptor antibody positive.

All patients were acetyl choline receptor antibody positive.

Speaker 6: GMG is a chronic debilitating disease characterized by a loss of muscle function and severe muscle.

CMT is a chronic debilitating disease characterized by loss of muscle function and muscle weakness.

Speaker 6: In China, patients are often treated with atrifugiline esterase inhibitors, steroids, immunosuppressants, and IVIG. Atrifugiline esterase inhibitors and steroids are used as initial therapies.

Kinda pieces are often treated with <unk> inhibitors steroids.

Immunosuppressants and <unk>.

And <unk> inhibitors and steroids.

<unk> initial therapies.

Speaker 6: The current available treatments for GMG has limited efficacy and ISO she would significantly...

The occurred available treatments for TMT have limited efficacy and are associated with significant side of things.

Speaker 6: the high prevalence of these diseases, coupled with the current unsatisfactory treatment

With a high prevalence of these diseases, coupled with the current unsatisfactory treatment options patients are in urgent need of a safe and effective treatment option that can control symptoms faster.

Speaker 6: patients are in urgent need of a safe and effective treatment option that can control

Harald Reinhart: Furthermore, in July, we announced the NMPA's acceptance of the biologic license application or BLA for the subcutaneous formulation of VYVGART for gMG. Once approved, this will provide patients with increased dosing flexibility and convenience. In July, we and our partner, argenx, were happy to announce positive top-line results in the ADHERE study, a trial in patients with CIDP or chronic inflammatory demyelinating polyneuropathy. Before presenting the key results, I would like to provide background information on CIDP in China. In China, the prevalence of disease is estimated at approximately 50,000 patients. CIDP is a chronic progressive autoimmune disease that is characterized by weakness and impaired sensory function that often worsens over time. The disease is debilitating, causing immobility, difficulty with walking and balance, and patients are often left unable to perform simple daily tasks.

Harald Reinhart: Furthermore, in July, we announced the NMPA's acceptance of the biologic license application or BLA for the subcutaneous formulation of VYVGART for gMG. Once approved, this will provide patients with increased dosing flexibility and convenience. In July, we and our partner, argenx, were happy to announce positive top-line results in the ADHERE study, a trial in patients with CIDP or chronic inflammatory demyelinating polyneuropathy. Before presenting the key results, I would like to provide background information on CIDP in China. In China, the prevalence of disease is estimated at approximately 50,000 patients. CIDP is a chronic progressive autoimmune disease that is characterized by weakness and impaired sensory function that often worsens over time. The disease is debilitating, causing immobility, difficulty with walking and balance, and patients are often left unable to perform simple daily tasks.

Speaker 6: Furthermore, in July , we announced the NMPA's acceptance of the biological license applications of BLA with a subcutaneous formulation of VSCI.

Furthermore, in July we announced the Npa's acceptance of the biologic license application BLA for the subcutaneous formulation of this guide for Gmg.

Speaker 6: Once approved, this will provide patients with increased dose inflexibility and convenience.

It's approved this will provide patients with increased dosing flexibility and convenience.

Speaker 6: Shulali, we, you know, part-dargenics were happy to announce positive top-line results in the ad-t- s- s- s- s- s- s- s- s- s- s- s- s- s- s- s- s- s- s- s- s- s- s-

In July .

And because we are happy to announce positive top line results in the FCS study.

Speaker 6: Attrial in patients with CIDP or chronic inflammatory demyelinating polinous.

A trial in patients with C IDP or chronic inflammatory demyelinating polyneuropathy.

Speaker 6: Before presenting the key results, I would like to provide background information on CIDP.

Before presenting the key results I would like to provide background information see ADP in China.

Speaker 6: In China, the prevalence of disease is estimated at approximately 50,000...

China has a prevalence of disease is estimated at approximately 50000 patients.

Speaker 6: DIP is a chronic progressive autoimmune disease that is characterized by weakness and impaired by sensory function that often worsens over time.

<unk> is a chronic progressive autoimmune disease.

Characterized by weakness in impaired sensory function that often worsens over time.

Speaker 6: The disease is debilitating causing immobility, difficulty with walking and balance, and patients are often less unable to perform simple daily tests.

The disease is debilitating, causing E mobility difficulty with walking imbalance and patients are often less unable to perform simple daily tasks.

Harald Reinhart: Current treatment options are primarily steroids and intravenous immunoglobulin, IVIG, or plasma exchange, PLEX, generally reserved for refractory patients. There are limitations to each of these therapies, including the well-known shortage of IVIG, as well as the significant burden associated with administration, especially for PLEX and IVIG. With long-term steroid use, adverse events become a concern. As most patients require chronic treatment, there remains a significant unmet need for alternative treatment options that are effective, well-tolerated, and convenient for patients with CIDP in China. The Attias study was the largest CIDP trial ever conducted, with 322 patients entering stage A. The enrolled patient population was representative of the real world of CIDP patients and included treatment-naive patients off treatment for at least six months, and those who have been on IVIG or steroids within the last six months.

Harald Reinhart: Current treatment options are primarily steroids and intravenous immunoglobulin, IVIG, or plasma exchange, PLEX, generally reserved for refractory patients. There are limitations to each of these therapies, including the well-known shortage of IVIG, as well as the significant burden associated with administration, especially for PLEX and IVIG. With long-term steroid use, adverse events become a concern. As most patients require chronic treatment, there remains a significant unmet need for alternative treatment options that are effective, well-tolerated, and convenient for patients with CIDP in China. The Attias study was the largest CIDP trial ever conducted, with 322 patients entering stage A. The enrolled patient population was representative of the real world of CIDP patients and included treatment-naive patients off treatment for at least six months, and those who have been on IVIG or steroids within the last six months.

Speaker 6: Current treatment options are primarily steroids and intravenous immunoglobulin IVIG, or plasma exchange plex. Generally reserved for all certain levels of immunoglobulin positive indices of extremeaid monstrously Ionizing COVID-10 Powerazer arranged it to suggest price level levels as imagined, and thenORPGlaughing originally MeatyG lady Oh TC What it might ma st Over mutant in We have

Current treatment options are primarily steroids and intravenous immunoglobulin IV AIG webcast may exchange clinics.

Generally reserved for refractory patients.

Speaker 6: There are limitations to each of these therapies, including the well-known shortage of IVIG, as well as the significant burden associated with administration, especially for plexin IVIG. With long-term steroid use at...

There are limitations to each of these therapies, including the well known shortage of IV.

As well as a significant burden associated with administration basically for flex and IV.

With long term steroid use entries events become a concern.

Speaker 6: As most patients require chronic treatment, there remains a significant unmet need for alternative treatment options that are effective, well tolerated, and convenient for patients with CIDP in China.

As most patients require chronic treatment.

Means a significant unmet need for alternative treatment option to the effective well tolerated and convenient for patients with CDP in China.

Speaker 6: The ATIA study was the largest CICP trial ever conducted with 322 patients entering stage A.

The <unk> study was the largest CSP trial ever conducted with 322 patients entering stage eight.

Speaker 6: The enrolled patient population was representative of the real world of CIDP patients and included treatment naive patients, patients off treatment for at least six months, and those who have been on IVIG or steroids within the last

The enrolled patient population was representative of the real world.

Patients and included treatment naive patients patients are treatment for at least six months and those who have been on <unk> or steroids within the last six months.

Harald Reinhart: In stage A, we saw that 67% of patients demonstrated evidence of clinical improvement and up to 78% in patients that received a full series of 4 doses of VYVGART. In stage B, we made our primary efficacy endpoint, demonstrating a significantly lower risk of relapse with VYVGART Hytrulo. This was a well-designed placebo-controlled trial with time to first adjusted INCAT deterioration as its primary endpoint. The P value was highly significant, driven by a hazard ratio of 0.39, indicating that VYVGART Hytrulo reduces the risk of relapse by 61%. This positive data provides strong clinical evidence that VYVGART Hytrulo meaningfully improves and stabilizes disease symptoms in CIDP patients. As in other studies, efgartigimod treatment had a favorable safety profile. We believe with this profile there's a clear benefit over existing treatments.

Harald Reinhart: In stage A, we saw that 67% of patients demonstrated evidence of clinical improvement and up to 78% in patients that received a full series of 4 doses of VYVGART. In stage B, we made our primary efficacy endpoint, demonstrating a significantly lower risk of relapse with VYVGART Hytrulo. This was a well-designed placebo-controlled trial with time to first adjusted INCAT deterioration as its primary endpoint. The P value was highly significant, driven by a hazard ratio of 0.39, indicating that VYVGART Hytrulo reduces the risk of relapse by 61%. This positive data provides strong clinical evidence that VYVGART Hytrulo meaningfully improves and stabilizes disease symptoms in CIDP patients. As in other studies, efgartigimod treatment had a favorable safety profile. We believe with this profile there's a clear benefit over existing treatments.

Speaker 6: In stage A, we saw that 67% of patients demonstrated evidence of clinical improvement and up to 78% in patients that received a full series of four doses of COVID-19.

In <unk>, we saw that 67% of patients demonstrated evidence of clinical improvement and up to 78% in patients that received a full series of full doses of this guy.

Speaker 6: In stage B, we made our primary efficacy endpoint, demonstrating a significantly lower risk of relapse with contingent ascending Affectation.

In stage B, we made our primary efficacy endpoints, demonstrating a significantly lower risk of relapse with risk ahead, hi tuna.

Speaker 6: This was a well-designed placebo control trial, with time to first adjusted in-cat deterioration as its primary endpoint.

This was a well designed placebo controlled trial with time to first adjusted inkjet deterioration as its primary endpoint.

Speaker 6: P value was highly significant driven by a hazard ratio of 0.39 indicating that risk-guide hydrolysis or risk-of-free lapse by 61.

P value was highly significant driven by a hazard ratio of <unk> 39, indicating the risk architectural or reduce the risk of relapse by 61%.

Speaker 6: This process data provides strong clinical evidence that we've got a true or meaningfully improved and stabilizes disease symptoms in CID.

This positive data provide strong clinical evidence that we've got.

Trudeau meaningfully improves and stabilize the disease symptoms in <unk> patients.

Speaker 6: other studies. If got teagamut treatment had a favorable safety probe.

And other studies if got taken my treatment had received verbal safety profile.

Speaker 6: We believe with this profile there is a clear benefit over existing

We believe with this profile there is a clear benefit over existing treatments.

Harald Reinhart: Therefore, VYVGART Hytrulo has the potential to dramatically change the treatment paradigm for CIDP in China. We also see a significant potential of efgartigimod across multiple indications, and we will continue to work with our partner, argenx, on indication expansion similar to the ADHERE study, where Zai Lab contributed a significant number of patients. Regarding our infectious diseases portfolio, in May, our partner, Entasis, now Innoviva, announced that the FDA approved XACDURO or sulbactam-durlobactam for the treatment of adults with hospital-acquired pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii. Our NDA was accepted by the NMPA in China in February and is now under priority review. We look forward to bringing this novel drug to China and Asia Pacific, where severe carbapenem-resistant or CRAB infections are frequent and often can no longer be adequately treated because of multidrug resistance. Switching now to KarXT.

Harald Reinhart: Therefore, VYVGART Hytrulo has the potential to dramatically change the treatment paradigm for CIDP in China. We also see a significant potential of efgartigimod across multiple indications, and we will continue to work with our partner, argenx, on indication expansion similar to the ADHERE study, where Zai Lab contributed a significant number of patients. Regarding our infectious diseases portfolio, in May, our partner, Entasis, now Innoviva, announced that the FDA approved XACDURO or sulbactam-durlobactam for the treatment of adults with hospital-acquired pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii. Our NDA was accepted by the NMPA in China in February and is now under priority review. We look forward to bringing this novel drug to China and Asia Pacific, where severe carbapenem-resistant or CRAB infections are frequent and often can no longer be adequately treated because of multidrug resistance. Switching now to KarXT.

Speaker 6: Therefore, Vivkatatrulo has the potential to dramatically change the treatment paradigm for CIDP in China.

Therefore, <unk> has the potential to dramatically change the treatment paradigm for <unk> in China.

Speaker 6: We also see a significant potential of F-GAT TIGIMOD across multiple indications. It will continue to work with our partner, Igenix, on indication expansion similar to the ATIA study where PSI contributed a significant number of cases.

We also see a significant potential of <unk> across multiple indications and as they continue to work with our partner clinics when indication expansion similar to the <unk> study were Si contributed a significant number of patients.

Speaker 6: Regarding our infectious diseases portfolio in May, our partner in cases now in O'Viva announced that the FDA approved suck duoro or so the back-down, duolo back-down for the treatment of adults with hospital acquired pneumonia and fatally nervous surgery picture pneumonia caused by susceptible strains of acid-bacter bulmonia.

Our infectious disease portfolio in May our partner in cases, now at Aviva and announced that the FDA approved.

We pulled back and <unk> for the treatment of adults with hospital acquired pneumonia and ventilator. So if you picture pneumonia.

First by susceptible strains of acinetobacter by ammonia.

Speaker 6: Our NDA was accepted by the NNP in China in February . It is now under priority rules.

Our NDA was accepted by the NFPA, China in February and is now under priority review.

Speaker 6: We look forward to bringing this novel to China and Asia Pacific with the cover pen resistance or crap infections of frequent.

We look forward to bringing this novel direct to China and Asia Pacific.

Cover pin resistant.

Crap infections are frequent and often can no longer be adequately treated because of multi drug resistance.

Good thing now to car T.

Harald Reinhart: We initiated a clinical bridging study in China in June to support China registration. KarXT is the combination of xanomeline and trospium, which we are developing with our partner Karuna for acute schizophrenia. Karuna plans to submit a new drug application to the FDA in Q3 2023, with a potential launch in H2 2024 if approved. KarXT could be a very important treatment option as a new class of medicine for schizophrenia patients in China and globally. Now Yajing will speak about progress with our commercial products and financial results. Yajing.

Harald Reinhart: We initiated a clinical bridging study in China in June to support China registration. KarXT is the combination of xanomeline and trospium, which we are developing with our partner Karuna for acute schizophrenia. Karuna plans to submit a new drug application to the FDA in Q3 2023, with a potential launch in H2 2024 if approved. KarXT could be a very important treatment option as a new class of medicine for schizophrenia patients in China and globally. Now Yajing will speak about progress with our commercial products and financial results. Yajing.

Speaker 6: We initiated a clinical bridging study in China in June to support

We initiated a clinical bridging study in China in June to support China registration.

Speaker 6: CARDS T is the combination of pranomidine and TROS.

<unk> is the combination of phenomenal interest PM, which we're developing with our current partner Corona for acute schizophrenia.

Speaker 6: are developing with our partner Karuna for acute schizophrenia.

Speaker 6: Corona plans to submit a new drug application to the FDA in the third quarter of 2023 with a potential launch in the second half of 2024 if approved. Car-XT could be a very important treatment option as a new class of medicine.

Corona plans to submit a new drug application to the FDA in the third quarter of 2023 with a potential launch in the second half of 2024 if approved.

<unk> could be a very important treatment option as a new class of medicine for schizophrenia patients.

China and globally.

Speaker 6: And now, Yachin, we'll speak about progress with our commercial products and financial research.

And now <unk> will speak about progress with our commercial products and financial results.

Yajing Chen: Thank you, Harold. Now I will discuss our Q2 2023 financial results compared to the prior year period. Total net product revenue for the Q2 2023 was $69 million, compared to $48 million for the same period in 2022, representing year-over-year growth of 45%. On a constant currency basis, growth year-over-year was 53%. The increase in net product revenue was primarily due to increased sales volume and a decreased negative effect from the COVID-19 pandemic. Our total net product revenue included $43 million for ZEJULA, which increased 26% year-over-year, $14 million for Optune, which increased 18% year-over-year, and $7.5 million for QINLOCK, which increased from $0.6 million for the same period in 2022.

Yajing Chen: Thank you, Harold. Now I will discuss our Q2 2023 financial results compared to the prior year period. Total net product revenue for the Q2 2023 was $69 million, compared to $48 million for the same period in 2022, representing year-over-year growth of 45%. On a constant currency basis, growth year-over-year was 53%. The increase in net product revenue was primarily due to increased sales volume and a decreased negative effect from the COVID-19 pandemic. Our total net product revenue included $43 million for ZEJULA, which increased 26% year-over-year, $14 million for Optune, which increased 18% year-over-year, and $7.5 million for QINLOCK, which increased from $0.6 million for the same period in 2022.

Speaker 7: Thank you, Harold. Now, I will discuss our second quarter, 2020-3 financial result, compared to the prior year period.

Thank you now I will discuss our second quarter 2023 financial results compared to the prior year period.

Speaker 7: Total net profit revenue for the second quarter of 2023 was $69 million. Compared to $48 million for the same period in 2022. Representing year over year growth.

Hold on that property revenue for the second quarter of 2023 was $69 million.

Compared to $48 million for the same here in 2022.

<unk> year over year growth of 45%.

Speaker 1: On a constant currency basis, growth year over year was 53.

Constant currency basis.

Ill begin with 53%.

Speaker 1: The increasing that parking revenue was primarily due to increase sales volume and a decreased negative effect from the COVID-19 to that.

The increasing that parking revenue was primarily due to increased sales volume and a decrease negative effects from the COVID-19 pandemic.

Speaker 1: Our total net park revenue included 43 million dollars for the jeweler, which increased 26% year over year. 14 million dollars for up to which increased 18% year over.

Our total net pocket revenue included $43 million for the Qunar, which increased 26% year over year $14 million for our Q, which increased 18% year over year.

Speaker 1: $7.5 million for Tinga, which increased from 0.6 million for the same period in 2020.

$7 $5 million for Cunard, which increased from $6 million for the thank you in 2022.

Yajing Chen: $4.6 million for NUZYRA, which increased from $1.3 million for the same period in 2022. Research and development expenses were $77 million for Q2 2023, compared to $66 million for the same period in 2022. The increase in R&D expenses was primarily due to increased research activity and clinical pipeline advancement. Selling, general, and administrative expenses were $68 million for Q2 2023, compared to $63 million for the same period in 2022. The increase was primarily due to higher general selling expenses to support new product launches.

Yajing Chen: $4.6 million for NUZYRA, which increased from $1.3 million for the same period in 2022. Research and development expenses were $77 million for Q2 2023, compared to $66 million for the same period in 2022. The increase in R&D expenses was primarily due to increased research activity and clinical pipeline advancement. Selling, general, and administrative expenses were $68 million for Q2 2023, compared to $63 million for the same period in 2022. The increase was primarily due to higher general selling expenses to support new product launches.

Speaker 1: And $4.6 million for New Zayra, which increased from $1.3 million for the same period in 2022.

And $4 $6 million towards the Q4, new silo, which increased from $1 3 million for the same period in 2022.

Speaker 1: Research and development expenses were $77 million for the second quarter of 2023, compared to $66 million for the same period in 2022.

Research and developing census was $77 million for the second quarter of 2020.

Compared to $66 million for the same period in 2022.

Speaker 1: The increase in R&D expenses was primarily due to increased research activities and clinical pipeline advances in the clinical pipeline.

The increase in R&D expenses was primarily due to increased research activity and clinical pipeline advancement.

Speaker 1: Selling general and administrative expenses was $68 million for the second quarter of 2023, compared to $63 million for the same period in 2022.

Sony General and administrative expenses of $268 million for the second quarter of 2020 compared to $63 million for the same period in 2022.

Speaker 1: The increase was primarily due to higher genocidal expenses to support new popular loans.

The increase was primarily due to higher selling expenses to support new pocket launch it.

Yajing Chen: Zai Lab reported a net loss of $121 million, or a loss per ordinary share of $0.13 for Q2 2023, compared to a net loss of $138 million for the same period in 2022, or a loss per ordinary share of $0.14. The decrease in net loss was primarily due to product revenue growing faster than net operating expenses. We are in a strong financial position, ending the quarter with $876 million in cash and cash equivalents, short-term investment, and restricted cash, compared to $931 million as of 31 March 2023. Based on our operating plan and our anticipated revenue growth, we expected to be able to fund our business until we reach profitability, which is currently expected by the end of 2025.

Yajing Chen: Zai Lab reported a net loss of $121 million, or a loss per ordinary share of $0.13 for Q2 2023, compared to a net loss of $138 million for the same period in 2022, or a loss per ordinary share of $0.14. The decrease in net loss was primarily due to product revenue growing faster than net operating expenses. We are in a strong financial position, ending the quarter with $876 million in cash and cash equivalents, short-term investment, and restricted cash, compared to $931 million as of 31 March 2023. Based on our operating plan and our anticipated revenue growth, we expected to be able to fund our business until we reach profitability, which is currently expected by the end of 2025.

Speaker 1: Right, a report is in that lot of $121 million. Or a lot per ordinary share of 13 cents for the second quarter of 2020.

<unk> reported a net loss of $121 million or a loss per ordinary share of <unk> for the.

Quarter of 2023.

Speaker 1: Compared to a net mass of 138 million dollars for the same period in 2022, or last per ordinary share of 14...

To a net loss of $138 million for the same period in 2022 loss per ordinary share of <unk> 14.

Speaker 1: The decreasing net loss was primarily due to your profit revenue growing faster than net operating expense.

The decrease in net loss was primarily due to project revenue is growing faster than net operating expenses.

Speaker 1: We are in a strong financial position and in the quarter with $876 million in cash and cash equivalent, short and investment and restricted.

We are having a strong financial position ending the quarter with $876 million in cash and cash equivalents and short term investment and the restricted cash.

Speaker 1: compared to $931 million as of March 31, 2020.

Two $931 million as of March 31, 2023.

Speaker 1: Based on our operating plan and our anticipated revenue growth, we expected to be able to fund our business until we reach profitability, which is currently expected by the end of 2025.

Based on our operating plan and our anticipated revenue growth.

Actually to be able to fund our business until we reach profitability, which is currently expected by the end of 'twenty three.

Yajing Chen: With that, I would now like to turn the call back over to the operator to open up the line for questions. Operator?

Yajing Chen: With that, I would now like to turn the call back over to the operator to open up the line for questions. Operator?

Speaker 1: And with that, I would now like to turn the call back over to the operator to open up the line for questions operator.

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

Operator.

Operator: Thank you. We would now like to open the line for questions. If you have questions, please press star one one at this time. To withdraw your question, please press star one one again. Our first question comes from the line of Ziyi Chen from Goldman Sachs. Please ask your question, Ziyi.

Operator: Thank you. We would now like to open the line for questions. If you have questions, please press star one one at this time. To withdraw your question, please press star one one again. Our first question comes from the line of Ziyi Chen from Goldman Sachs. Please ask your question, Ziyi.

Thank you.

We would now like to open the line for questions.

Speaker 8: If you have questions, please press star 11 at this time. To withdraw your question, please press star 11 again.

You have a question. Please press star one one at this time to withdraw your question. Please press star one again.

Speaker 8: Our first question comes from the line of Zhi Chen from Goldman Sachs. Please ask your question, Zhi.

Our first question comes from the line of <unk> Chen from Goldman Sachs. Please ask your question C.

Ziyi Chen: Thank you for giving me the opportunity to raise the first questions. I got two questions. I think in the past two weeks in China, the anti-corruption campaign has been one of the key topics in the healthcare industry. We try to understand a bit more about that, and particularly the potential impact on Zai Lab's commercial activities, including efgartigimod, the launch event, 'cause we think that's gonna be really important for not only this year but also over the next few years. Our second question also regarding efgartigimod. While the positive top-line data coming for CIDP is pretty encouraging, we're trying to understand a bit more about the clinical practice difference in China versus in the US, and how that could potentially affect the clinical development in China and also the potential in China.

Ziyi Chen: Thank you for giving me the opportunity to raise the first questions. I got two questions. I think in the past two weeks in China, the anti-corruption campaign has been one of the key topics in the healthcare industry. We try to understand a bit more about that, and particularly the potential impact on Zai Lab's commercial activities, including efgartigimod, the launch event, 'cause we think that's gonna be really important for not only this year but also over the next few years. Our second question also regarding efgartigimod. While the positive top-line data coming for CIDP is pretty encouraging, we're trying to understand a bit more about the clinical practice difference in China versus in the US, and how that could potentially affect the clinical development in China and also the potential in China.

Speaker 9: Thank you for giving me the opportunity for a raise of first questions. I got two questions. I think in the past two weeks in China, the anti-corruption campaign has been one of the key topic in the healthcare industry. So we try to understand a bit more about that and particularly the potential impact on Zilab's commercial activities, including F-Grotagemod, the long-term care

Thank you for giving me the opportunity for our recent first questions I've got two questions I think in the past two weeks in China. The anti corruption campaign has been one of the key topic in the health care industry. So we try to understand a bit more about that particularly the potential <unk>.

<unk> commercial activities.

<unk> <unk> at the launch event.

Speaker 9: because we think that's gonna be really important for not only this year but also over the next few years.

Think thats going to be really important for not only this year, but also over the next few years.

Speaker 9: Our second question also regarding F-Cartage Mod, well, the positive top-line data coming for CIDP is pretty encouraging, but we try to understand a bit more about the clinical practice difference in China versus in the US, and how that could potentially affect the clinical development in China, and also the potential in China. Thank you.

Second question also regarding <unk>.

While the positive topline data coming for CIB piece pretty encouraging.

But we're trying to understand a bit more a bit more about the clinical practice difference in China versus in the U S and how that could potentially affect the clinical development in China and also the potential in China. Thank you.

Ziyi Chen: Thank you.

Ziyi Chen: Thank you.

Josh Smiley: Great. Thank you for the question. It's Josh Smiley. I'll take the anti-corruption question first, and it's important, and then I'll ask Harald Reinhart to provide a little bit more color on current clinical practice and where we see efgartigimod fitting in CIDP. On anti-corruption first, we don't expect any impact operationally to our commercial business or practices. In fact, I think we believe the anti-corruption focus is gonna be a positive force in the healthcare industry, since it promotes high standards of care and it's a positive point of comparison for companies like Zai Lab. If you look at our portfolio, it's been highly innovative and differentiated products, so our commercial practice is focused on medical education.

Josh Smiley: Great. Thank you for the question. It's Josh Smiley. I'll take the anti-corruption question first, and it's important, and then I'll ask Harald Reinhart to provide a little bit more color on current clinical practice and where we see efgartigimod fitting in CIDP. On anti-corruption first, we don't expect any impact operationally to our commercial business or practices. In fact, I think we believe the anti-corruption focus is gonna be a positive force in the healthcare industry, since it promotes high standards of care and it's a positive point of comparison for companies like Zai Lab. If you look at our portfolio, it's been highly innovative and differentiated products, so our commercial practice is focused on medical education.

Speaker 4: Great, thank you for the question. It's Josh Smiley. I'll take the anti-corruption question first and it's important and then

Great. Thank you for the question.

Josh Smiley I I'll take the anti corruption question first and that's important and then.

Speaker 4: I'll ask Carol to provide a little bit more color on current clinical practice and where we see F-Cartagemont fitting in in CIPP. On anti-corruption first, we don't expect any impact operationally to our commercial business or practices. In fact, I think we believe the anti-corruption focus is going to be a positive force in the healthcare industry.

I'll ask Carol to provide a little bit more color on.

Current clinical practice, and where we see <unk> fitting in in CIB on anti corruption first.

We don't expect any impact operationally to our commercial business our practices. In fact, I think we believe the anticorruption focus is going to be a positive force in the health care industry.

Speaker 4: since it promotes high standards of care and it's a positive point of comparison for companies like ZyLab.

It promotes high standards of care and it's a positive point of comparison for companies like XI lab. If you look at our portfolio, we've got highly innovated and differentiated products. So our commercial practices focused on.

Speaker 4: If you look at our portfolio, we've got highly innovative and differentiated products. So our commercial practices focus on medical education. And we believe those will be unaffected and unimpacted by any of this focus. I think as you all know, we've always been committed to serving the needs of patients with highly innovative first in class, best in class types of products.

Josh Smiley: We believe those will be unaffected and unimpacted by any of this focus. I think as you all know, we've always been committed to serving the needs of patients with highly innovative first-in-class, best-in-class types of products. Our commercial practices adhere to the highest standards of ethics and regulations across China. Also, you know, one of the things that's made us very attractive to global partners is our focus on commercial excellence and ethics and compliance. Again, I think from a general standpoint, we don't see any changes or operational impact as a result of this focus.

Medical education.

Josh Smiley: We believe those will be unaffected and unimpacted by any of this focus. I think as you all know, we've always been committed to serving the needs of patients with highly innovative first-in-class, best-in-class types of products. Our commercial practices adhere to the highest standards of ethics and regulations across China. Also, you know, one of the things that's made us very attractive to global partners is our focus on commercial excellence and ethics and compliance. Again, I think from a general standpoint, we don't see any changes or operational impact as a result of this focus.

We believe those will be unaffected and not impacted by any of this any of this focus I think as you. All know we've always been committed to serving the needs of patients with highly innovative first in class best in class types of products or commercial practices adhere to the highest standards of.

Speaker 4: our commercial practices here to the highest standards of ethics and regulations across China and also one of the things that's made us very attractive to global partners is our focus on.

S.

Sex and regulations across China and also.

One of the things that made us very attractive to global partners is our focus on.

Speaker 4: commercial excellence and ethics and compliance. So again, I think from a general standpoint, we don't see any changes or operational impact as a result of this focus. And we think the more any country focuses on quality education and emphasis on differentiated products, I think, is a good thing long term. As it relates specifically to F. Garcigia Mod, again, our focus here with this best in class and first in class product is educating.

Our commercial excellence and <unk>.

<unk> and compliance so again I think from a general standpoint, we don't see any changes or operational impact as a result of this focus and we think the more.

Josh Smiley: We think the more any country focuses on, you know, quality education and emphasis on, you know, differentiated products, I think is a good thing long term. As it relates specifically to efgartigimod, again, our focus here with this best-in-class and first-in-class product is educating the healthcare provider community. We've been doing that, you know, since the approval. We're in the process of doing that now. We haven't stepped back or been impacted in any way by this emphasis. We don't expect there to be any impact on the launch activities that we have planned. We have. We'll move into a full commercial launch later this year.

Josh Smiley: We think the more any country focuses on, you know, quality education and emphasis on, you know, differentiated products, I think is a good thing long term. As it relates specifically to efgartigimod, again, our focus here with this best-in-class and first-in-class product is educating the healthcare provider community. We've been doing that, you know, since the approval. We're in the process of doing that now. We haven't stepped back or been impacted in any way by this emphasis. We don't expect there to be any impact on the launch activities that we have planned. We have. We'll move into a full commercial launch later this year.

Any country focus is on <unk>.

Quality.

<unk> and emphasis on.

Differentiated products I think is a good thing long term as it relates specifically to <unk> again, our focus here with this best in class and first in class product is educating.

Speaker 4: the healthcare provider community. We've been doing that since the approval were in the process of...

The health care provider community, we've been doing that since the approval we are in the process of.

Speaker 4: Of doing that now we haven't stepped back or been impacted in any way by by this emphasis. So we don't expect there to be any impact on the launch activities that we have planned. And we have.

Doing that now we haven't stepped.

Step back or been impacted.

And any way bye bye. This emphasis so we don't expect there to be any impact on the launch activities that we have planned and we have.

Speaker 4: We'll move into a full commercial launch later this year, but for now we're educating physicians and providers in major cities and we'll continue to do that. So again, overall, we are excited about the opportunity to bring Vivgard to a Chinese patient.

We will move into a full commercial launch later this year, but for now we're educating physicians and providers in major cities and we'll continue to do that so again overall, we are excited about the opportunity to bring.

Josh Smiley: You know, for now we're educating physicians and providers in major cities and we'll continue to do that. Again, overall, we are excited about the opportunity to bring new VYVGART to Chinese patients. We think that the emphasis that we're seeing from the anti-corruption campaign will not impact that and in fact will help us from a differentiated perspective. I think transitioning now to CIDP, Harald, maybe you could provide a little bit more on current treatment paradigms and how VYVGART will fit.

Josh Smiley: You know, for now we're educating physicians and providers in major cities and we'll continue to do that. Again, overall, we are excited about the opportunity to bring new VYVGART to Chinese patients. We think that the emphasis that we're seeing from the anti-corruption campaign will not impact that and in fact will help us from a differentiated perspective. I think transitioning now to CIDP, Harald, maybe you could provide a little bit more on current treatment paradigms and how VYVGART will fit.

They've got to Chinese patients, we think that the emphasis that we are.

Speaker 4: We think that the emphasis that we're seeing from the anti-corruption campaign will not impact that, in fact will help us from a differentiated perspective.

Seeing from anti corruption campaign.

Might impact that in fact will help us from a differentiated perspective.

Speaker 4: I think transitioning now to CIVP, Harold, maybe you could provide a little bit more on current treatment paradigms and how VibGardle fit.

Transitioning now to see IDP, Harold maybe you could provide a little bit more on current treatment paradigms and how they've guard will fit.

Harald Reinhart: Yeah, thank you. The question was about clinical practice, US versus China for CIDP treatment. Overall, the treatment is fairly similar. It is, as we said before, it usually starts with steroids, long-term steroids in those milder patients. If necessary, the next step would be IVIG. This is by guidelines that were recently, you know, promulgated in Europe and in the US, and China is using the same kind of regimen. Steroids followed by IVIG based on supply. This is a treatment in these patients that is oftentimes required for a long, long time. Let me just add a sentence about the disease because it's not so well understood and often spoken about. This is a chronic demyelinating disease, and the progression is usually over months to years.

Harald Reinhart: Yeah, thank you. The question was about clinical practice, US versus China for CIDP treatment. Overall, the treatment is fairly similar. It is, as we said before, it usually starts with steroids, long-term steroids in those milder patients. If necessary, the next step would be IVIG. This is by guidelines that were recently, you know, promulgated in Europe and in the US, and China is using the same kind of regimen. Steroids followed by IVIG based on supply. This is a treatment in these patients that is oftentimes required for a long, long time. Let me just add a sentence about the disease because it's not so well understood and often spoken about. This is a chronic demyelinating disease, and the progression is usually over months to years.

Speaker 6: Yeah, thank you. The question was about clinical practice, US versus China for CIDP treatment and overall the treatment is fairly similar. It is as we said before, it usually starts with...

Yes. Thank you.

Question was about clinical practice U S versus China from CIB P treatment and overall the treatment is fairly similar.

It is as we said before it's usually starts with.

Speaker 6: steroids, long-term steroids in those milder patients. And if necessary, the next step would be IVIG. This is my guidelines that go recently.

Long term steroids in those minded patients.

Yes.

This is really the next step would be IV AIG.

This is my guidelines that were recently.

Speaker 6: propagated in Europe and in the US, and China is using the same kind of regimen. So steroids followed by IVIG based on supply, this is a treatment in these patients that is oftentimes required for a long, long time.

Promulgated in Europe , and in the U S and.

China is using the same kind of regimen. So steroids, followed by IV based on supply.

A treatment in these patients.

Oftentimes required for a long long time.

Speaker 6: I just add a sentence about the disease because it's not so well understood and often spoken about. This is a chronic demyelinating disease and the progression is usually over months to years.

Just in a sentence about the disease, because it's not well understood and often spoken about.

This is a chronic demyelinating disease and the progression is usually over months two years. These patients once they asked the damage to the neurons and to the myelin sheath.

Harald Reinhart: These patients, once they have the damage to the neurons and to the myelin sheaths, they have a downhill course. Having only IVIG as a resort at the current time, efgartigimod really fits nicely into the treatment paradigm here. I do believe that we have a very, very underserved disease here, and as such, it has a really high potential to be used, and efgartigimod is filling a gap. Thank you so much for the question.

Harald Reinhart: These patients, once they have the damage to the neurons and to the myelin sheaths, they have a downhill course. Having only IVIG as a resort at the current time, efgartigimod really fits nicely into the treatment paradigm here. I do believe that we have a very, very underserved disease here, and as such, it has a really high potential to be used, and efgartigimod is filling a gap. Thank you so much for the question.

Speaker 6: These patients won't say have the damage to the neurons and to the myelons. Sheesh.

Speaker 6: They have a downhill course and having only IVIG as a resort at the current time, FGM really fits nicely into the treatment paradigm here. I do believe that we have very, very underserved disease here and as such it has a really high potential to be used and FGM is feeling agab. Thank you so much for the question. Thanks, Harold. Thank you.

They have a downhill course, and having only IV is a resort at the current time, if particular really fits nicely into the treatment paradigm here.

I do believe that.

We have.

Very very underserved disease here and as such it has really high potential to be used.

<unk> is filling a gap. Thank you so much for the question.

Josh Smiley: Thanks, Harald.

Josh Smiley: Thanks, Harald.

Thanks Sarah.

Jonathan Wang: Thank you, Josh, and thank you, Harald. Thank you.

Jonathan Wang: Thank you, Josh, and thank you, Harald. Thank you.

Thank you Joshua and thank Carol Thank you.

Operator: Thank you. Our next question comes from the line of Yigal Nochomovitz from Citi. Please ask your question, Igor.

Operator: Thank you. Our next question comes from the line of Yigal Nochomovitz from Citi. Please ask your question, Yigal.

Thank you.

Speaker 8: Our next question comes from the line of Ego Nocivmovic from City. Please ask your question Ego.

Our next question comes from the line of Eagle No just move it from Citi. Please ask your question igo.

Yigal Nochomovitz: Oh, yeah. Hi. Thank you very much for taking the questions. Just a few specific ones on VYVGART and then one on the finances. For VYVGART, for gMG, is there any potential to sell this product on a private pay basis, in the H2 before you get the NRDL listing?

Yigal Nochomovitz: Oh, yeah. Hi. Thank you very much for taking the questions. Just a few specific ones on VYVGART and then one on the finances. For VYVGART, for gMG, is there any potential to sell this product on a private pay basis, in the H2 before you get the NRDL listing?

Speaker 10: Yeah, hi, thank you very much for taking the question. Just a few specific ones on and then 1 on finances. Um, for ViGART for MG, is there any potential to sell this product on a private pay basis in the 2nd, half of the year before you get the NDRL listing?

Yes, hi, Thank you very much for taking the questions. Just a few specific ones on F. Garden, then one on the finances.

For <unk> for for MG is there any potential to sell this product on a private pay basis.

In the second half of the year before you get the <unk> listening.

Josh Smiley: Hey, Yigal, it's Josh Smiley. Yes, for sure. You know, we are, as I mentioned, we're in the midst of educating providers now. We'll have a full commercial launch later this year, and we do expect, you know, certainly expect commercial sales in Q4. Of course, we're, you know, very excited about the opportunity to list on NRDL early in 2024. So we've got a lot of activity going into that preparation. In the meantime, we will look to the private pay and supplemental insurance market for primarily the, you know, the third and fourth quarter of this year.

Josh Smiley: Hey, Yigal, it's Josh Smiley. Yes, for sure. You know, we are, as I mentioned, we're in the midst of educating providers now. We'll have a full commercial launch later this year, and we do expect, you know, certainly expect commercial sales in Q4. Of course, we're, you know, very excited about the opportunity to list on NRDL early in 2024. So we've got a lot of activity going into that preparation. In the meantime, we will look to the private pay and supplemental insurance market for primarily the, you know, the third and fourth quarter of this year.

Speaker 4: Hey, it's Josh. Yes, for sure. We are as I mentioned, we're in the midst of educating. Providers now we'll have a full commercial launch later this year and we do expect, you know, certainly expect commercial.

Hey, Yigal, it's Josh yes for sure.

We are as I mentioned, we're in the midst of educating providers now will have a full commercial launch later this year and we do expect.

Certainly expect commercial.

Speaker 4: sales in the fourth quarter of course were you know very excited about the opportunity to list on NRDL early in 2024 so we've got a lot of activity going into that preparation but in the meantime we will look to the private pay.

Sales in the fourth quarter of course, we're very excited.

About the opportunity to.

List on <unk> early in 2024, so we've got a lot of activity going into that preparation, but in the meantime, we will look to private pay and supplemental insurance market for primarily that.

Speaker 4: supplemental insurance market for primarily the third and fourth quarter of the

The third and fourth quarter of this year.

Yigal Nochomovitz: Okay. I'm not sure if I saw it, but when are you planning to file for CIDP in China and the timing to launch that?

Yigal Nochomovitz: Okay. I'm not sure if I saw it, but when are you planning to file for CIDP in China and the timing to launch that?

Speaker 10: Okay, and then I'm not sure if I saw it, but when are you planning to file for CIDP?

Okay, and then I'm not sure if I saw it but when are you planning to file for first the IDP.

Speaker 10: in China and the timing to launch that. I'll ask Carol to provide some comments but we'll, you know, we participated in the trial and we'll, you know, follow our Genics at the A-Semission. I hope you won't add anything to that. No, you're pretty much said it. We will follow the path that our Genics will use for CIDP and we will file in two time afterwards.

China and the timing to launch that I'll ask Carol to provide some comment but.

Josh Smiley: Yeah. I'll ask Harald to provide some comment, but we'll, you know, we participated in the trial and, we'll, you know, follow argenx FDA submission. Harald, if you wanna add anything to that.

Josh Smiley: Yeah. I'll ask Harald to provide some comment, but we'll, you know, we participated in the trial and, we'll, you know, follow argenx FDA submission. Harald, if you wanna add anything to that.

We participated in the in the trial and we will follow our genetics FDA submission Harold if you want to add anything to that.

Harald Reinhart: No, you pretty much said it. We will follow the path that argenx will use for CIDP, and we will file in due time afterwards.

Harald Reinhart: No, you pretty much said it. We will follow the path that argenx will use for CIDP, and we will file in due time afterwards.

We're pretty much said it we will fund over the past that we.

We use for CDP and we will file in <unk>.

Two time afterwards.

Yigal Nochomovitz: Okay.

Yigal Nochomovitz: Okay.

Josh Smiley: 2024 H1 filing, I think.

Josh Smiley: 2024 H1 filing, I think.

Speaker 4: Okay, 2024, 2024 first half filing. I think that's pretty much for the current anticipating.

The 2020 for 2024 first half filing I think that's pretty much what we're currently anticipating.

Harald Reinhart: That's pretty much what we are currently anticipating. Yes.

Harald Reinhart: That's pretty much what we are currently anticipating. Yes.

Josh Smiley: Yes.

Josh Smiley: Yes.

Yigal Nochomovitz: Okay. You know, I was looking at the slides from the Analyst Day from June, and I noticed that myositis was one of the indications that's got about a threefold higher representation in China, but it's not part of the global Phase 3 registration. I'm just wondering what the thoughts are there because it looked like a potentially attractive opportunity, but it doesn't seem to be emphasized right now. Harald Reinhart, if you want to-

Yigal Nochomovitz: Okay. You know, I was looking at the slides from the Analyst Day from June, and I noticed that myositis was one of the indications that's got about a threefold higher representation in China, but it's not part of the global Phase 3 registration. I'm just wondering what the thoughts are there because it looked like a potentially attractive opportunity, but it doesn't seem to be emphasized right now. Harald Reinhart, if you want to-

Speaker 10: Okay, and then, you know, I was looking at the slides from the analyst day from last, from June , I noticed that myositis was one of the indications that's got about a three-fold higher representation in China, but it's not part of the global phase three registration. I'm just wondering what the thoughts are there, because it looked like potentially attractive opportunity, but it doesn't seem to be emphasized right now.

Okay, and then I was looking at the slides from the analyst day from last from Jim I noticed myositis was one of the indications that's got about a three fold higher representation in China, but it's not part of the global Phase III registration I'm just wondering what the thoughts are there because it looks like a potentially attractive opportunity.

But it doesn't seem to be emphasized right now.

Harald Reinhart: Yes. Yeah, thanks for the question. It's indeed one of those many, many autoimmune diseases for which efgartigimod has a wonderful way of, hopefully turning around the course for patients. Myositis is like many of those indications are being considered by us and have been considered by us. We cannot do all of them, but we have decided instead to go with the, TED or other indications going forward. These decisions, you know, are being made with a partner, and we are in constant discussions with argenx here to select the next indications if we indeed go into myositis or into TED. These kinds of indications are open fields for an efgartigimod, treatment, and we believe that, we will, over time, address the needs of patients in these diseases, which are clearly all antibody-driven.

Harald Reinhart: Yes. Yeah, thanks for the question. It's indeed one of those many, many autoimmune diseases for which efgartigimod has a wonderful way of, hopefully turning around the course for patients. Myositis is like many of those indications are being considered by us and have been considered by us. We cannot do all of them, but we have decided instead to go with the, TED or other indications going forward. These decisions, you know, are being made with a partner, and we are in constant discussions with argenx here to select the next indications if we indeed go into myositis or into TED. These kinds of indications are open fields for an efgartigimod, treatment, and we believe that, we will, over time, address the needs of patients in these diseases, which are clearly all antibody-driven.

Speaker 4: Harold, if you want to. Yeah, thanks for the question. It's indeed one of those many, many autoimmune diseases for which, if the TIGIMOD has a wonderful way of hopefully turning around the course.

Apparel, if you will.

Okay, yes. Thanks for the question. It is indeed, one of those many many autoimmune diseases for which <unk> has a wonderful way of hopefully trading around the course for patients. My aside is like many of those indications are being considered by us.

Speaker 4: My aside is like many of those indications are being considered by us.

Speaker 4: They have been considered by us. We cannot do all of them, but we have decided in the Statue Goal with the...

Have been considered by US we cannot do all of them, but we have decided instead to go with the <unk>.

Speaker 4: Ted or other indications going forward. These decisions are being made with a partner and we are in constant discussions with our genics here to select.

Ted or other indications going forward. These decisions are being made with a partner and we are in constant discussions with I would say next year to select the next indications you see <unk> go into minus cytosorb into Ted So these kinds of.

Speaker 4: The next indications is if we, indeed, go into myocytes or intute. So these kinds of...

Speaker 4: indications are open fields for the F-CategiMod treatment and we believe that we will over time.

Indications are open fields for TD months' treatment and we believe that these are.

Sure.

Overtime.

Speaker 4: Address the needs of patients in these diseases which are clearly all in a bandage room.

Address the needs of patients in these diseases, which are clearly only into management.

Yigal Nochomovitz: Okay. Thanks, Harald. Then just two very quick ones. You mentioned the IVIG shortage in China. Is that sort of a permanent feature of the landscape there, or is that expected to resolve at some point? Then lastly, on the finances, I think this is the first time you've reported sales on a constant currency basis, if I recall. Is there a-

Yigal Nochomovitz: Okay. Thanks, Harald. Then just two very quick ones. You mentioned the IVIG shortage in China. Is that sort of a permanent feature of the landscape there, or is that expected to resolve at some point? Then lastly, on the finances, I think this is the first time you've reported sales on a constant currency basis, if I recall. Is there a-

Speaker 10: Okay, thanks Harold. And then just two very quick ones. With you mentioned the IVIG shortage in China, is that sort of a permanent feature of the landscape there or is that expected to resolve at some point? And then lastly, on the finances, I think this is the first time you've reported sales on a constant cardancy basis, if I recall, is there just a reason for the change there? And is that should we expect that metric going forward? Thanks.

Okay. Thanks, Harold and then just two very quick ones you mentioned the <unk> shortage in China is that sort of a permanent feature of the landscape there or is that expected to resolve.

At some point and then lastly on the finances I think this is the first time you've reported sales on a constant currency basis, if I recall.

Harald Reinhart: Mm-hmm

Harald Reinhart: Mm-hmm

Yigal Nochomovitz: ... just a reason for the change there? Should we expect that metric going forward? Thank you.

Yigal Nochomovitz: ... just a reason for the change there? Should we expect that metric going forward? Thank you.

Just a reason for the change there and is that should we expect that that.

Metric going forward. Thank you.

Josh Smiley: Yeah, just yeah, briefly, I think on IVIG, I think there's a, you know, it's a perpetual challenge, I think, in terms of supply. Jonathan, if you wanna add anything to that when I'm done here, you can. I think then on constant currency, Yigal, it was really just the fact that we've seen a, you know, over the course of the last year, a pretty significant depreciation relative to the US dollar. We wanted to make sure that, you know, given the fact that we report in dollars here, but, you know, are translating from RMB, we just wanna make sure that it was clear here. You should expect to see both going forward.

Josh Smiley: Yeah, just yeah, briefly, I think on IVIG, I think there's a, you know, it's a perpetual challenge, I think, in terms of supply. Jonathan, if you wanna add anything to that when I'm done here, you can. I think then on constant currency, Yigal, it was really just the fact that we've seen a, you know, over the course of the last year, a pretty significant depreciation relative to the US dollar. We wanted to make sure that, you know, given the fact that we report in dollars here, but, you know, are translating from RMB, we just wanna make sure that it was clear here. You should expect to see both going forward.

Speaker 11: Yeah, briefly, I think, I think it's an IDIG. I think there's, you know, it's a perpetual challenge.

Yes, just briefly.

I think there is.

Perpetual challenge I think in terms of supply.

Speaker 11: and if you want to add anything to that, when I'm done here, you can. But I think then on constant currency, I think all is really just the fact that we've seen over the course of the last year a pretty significant depreciation relative to the US dollar. We wanted to make sure that given the fact that we've reported dollars here, but our translates.

Jonathan if you want to add anything to that when I'm done here you can but.

I think that on constant currency.

Really just the fact that we've seen.

Over the course of the last year, a pretty significant depreciation.

Relative to the U S dollar and we wanted to make sure that.

Given the fact that we've reported dollars here, but are translating from.

Speaker 11: from RMB, we just want to make sure that it was clear here. So you should expect to see both going forward. We do, you know, expect some volatility in the currency and want to make sure that you get as clear, investors get a clearer picture of the overall operational impact of the business in China as we move forward. Okay, thank you.

From RMB, we just want to make sure that was clear here. So you should expect to see both going forward.

Josh Smiley: We do, you know, expect some volatility in the currency and wanna make sure that investors get as clear a picture of the overall operational impact of the business in China as we move forward.

Josh Smiley: We do, you know, expect some volatility in the currency and wanna make sure that investors get as clear a picture of the overall operational impact of the business in China as we move forward.

We do expect some volatility in the currency and want to make sure that you get it is clear investors get a clearer picture of the overall operational impacted the business in China as we move forward.

Yigal Nochomovitz: Okay. Thank you.

Yigal Nochomovitz: Okay. Thank you.

Okay. Thank you.

Josh Smiley: I think we can go to the next question, please, Amber.

Josh Smiley: I think we can go to the next question, please, Amber.

I think we can go to the next question. Please number.

Operator: Thank you. Our next question comes from the line of Michael Yee from Jefferies. Please ask your question, Michael.

Operator: Thank you. Our next question comes from the line of Michael Yee from Jefferies. Please ask your question, Michael.

Speaker 8: Thank you. Our next question comes from the line of Michael Wynn from Jefferies. Please ask your question, Michael. Hey guys, good morning, good afternoon. It's Michael Lee from Jefferies. Oh, we had two questions. One was on a particular mod. If you could just take a step back for us and remind us how we should think about reimbursement and pricing structure for rare orphan diseases. Here I know, for example, I think.

Thank you our.

Next question comes from the line of Michael win from Jefferies. Please ask your question, Michael Hey, guys. Good morning. Good afternoon, It's Michael <unk> from Jefferies.

Michael Yee: Hey, guys. Good morning. Good afternoon. It's Michael Yee from Jefferies. We had two questions. One was on efgartigimod. If you could just take a step back for us and remind us how we should think about reimbursement and pricing structure for rare orphan diseases here. I know, for example, I think if you look at SPINRAZA, it's a pretty low number compared to the US pricing. So just kinda walk us through the bookends on how to think about orphan pricing for efgartigimod, given that there's a potential big impact there on how to think about peak sales. Then, second question is going back to ZEJULA. I know there was a little bit of a slowdown here in Q2 versus Q1. Could you just remind us how to think about future growth here for the next year or so?

Michael Yee: Hey, guys. Good morning. Good afternoon. It's Michael Yee from Jefferies. We had two questions. One was on efgartigimod. If you could just take a step back for us and remind us how we should think about reimbursement and pricing structure for rare orphan diseases here. I know, for example, I think if you look at SPINRAZA, it's a pretty low number compared to the US pricing. So just kinda walk us through the bookends on how to think about orphan pricing for efgartigimod, given that there's a potential big impact there on how to think about peak sales. Then, second question is going back to ZEJULA. I know there was a little bit of a slowdown here in Q2 versus Q1. Could you just remind us how to think about future growth here for the next year or so?

Two questions one was on a particular market. If you could just take a step back for us and.

Remind us how we should think about reimbursement and pricing structure for rare orphan diseases here I know for example, I think.

Speaker 12: If you look at Spinraza, it's a pretty low number compared to the US pricing. Just walk us through the bookends on how to think about orphan pricing for F-Cartagemod, given that there's a potential big impact there on how to think about peak sales. Then the second question is going back to Zajulia. I know there was a little bit of a slowdown here in the second quarter versus the first quarter. Could you just remind us how to think about future growth here for the next year or so? I can't remember if.

If you look it's been rather it's a pretty.

Low number compared to the U S pricing, so just kind of walk us through the bookends on how to think about orphan pricing for a particular market given that there is a.

Potential big impact there on how to think about peak sales.

And then second question is going back to Julia I know that there was a little bit of a slowdown in the second quarter versus the first quarter could you just remind us how to think about future growth here for the next year or so I can't remember if.

Michael Yee: I can't remember if, obviously, the GSK compound may go generic or how to think about that, if there's any impact we should be aware of, in 2024. Thank you.

Michael Yee: I can't remember if, obviously, the GSK compound may go generic or how to think about that, if there's any impact we should be aware of, in 2024. Thank you.

Speaker 12: Obviously the GSK compound may go generic or how to think about that if there's any impact we should be aware of in 2024. Thanks.

I've received the GSK compound may go generic or how to think about that if there's any impact we should be aware of.

Josh Smiley: Great. Thank you, Michael. I guess first would say that you know, when you look at the patient populations across China for the various indications we're pursuing with VYVGART, it's sort of not really all that rare. I mean, we're looking at probably 400,000 patients across four lead indications now. So pricing, of course, is gonna reflect that, those kind of patient volume opportunities. I will say that we're, as I mentioned, preparing for a full commercial launch, but we do have a pre-NRDL price that's in US dollar terms, at least for gMG.

Josh Smiley: Great. Thank you, Michael. I guess first would say that you know, when you look at the patient populations across China for the various indications we're pursuing with VYVGART, it's sort of not really all that rare. I mean, we're looking at probably 400,000 patients across four lead indications now. So pricing, of course, is gonna reflect that, those kind of patient volume opportunities. I will say that we're, as I mentioned, preparing for a full commercial launch, but we do have a pre-NRDL price that's in US dollar terms, at least for gMG.

Thank you.

Speaker 11: Great. Thank you, Michael. And I guess first would say that, you know, when you look at the patient populations across China for the various indications we're pursuing with Deb Gart, you know, it's sort of not really all that rare. I mean, we're, you know, we're looking at probably 400,000.

Great. Thank you, Michael and I would say that.

When you look at the patient populations across China for the various indications we're pursuing.

Pursuing with depth guard.

It's sort of not really all that we're I mean, we're looking at probably 400000 patients across four lead indications now.

Speaker 11: across for lead indications now. And so pricing, of course, is going to reflect that those kind of patient volumes opportunities. I will say that we're, as I mentioned, we're preparing for a full commercial launch, but we do have a pre-NRDL price that's in US dollar terms at least for GMG when we look at cycles. And otherwise, it's about $47,000 per year. So that'll be our starting.

<unk>.

So pricing of course is going to reflect those kind of patient volumes opportunities I will say that we're as I mentioned were preparing for a full commercial launch, but we do have.

Our pre NR deal price.

In U S dollar terms at least for Gmg.

Josh Smiley: You know, when we look at cycles and otherwise, it's about $47,000 per year. So that'll be our starting pre-NRDL price. You know, as we've been very clear with everyone with the approval by 30 June this year, we expect to enter and be successful with NRDL negotiations for 2024.

Josh Smiley: You know, when we look at cycles and otherwise, it's about $47,000 per year. So that'll be our starting pre-NRDL price. You know, as we've been very clear with everyone with the approval by 30 June this year, we expect to enter and be successful with NRDL negotiations for 2024.

We look at cycles and otherwise, it's about $47000 per year, so that'll be our starting.

Speaker 11: pre-NRDL price and you know, we've been very clear with with everyone with the Approval by June 30th of this year we expect to enter and be successful within our DL negotiation

Pre at our Dl price and we've been very clear with what.

With everyone with the.

Approval by June 30 of this year, we expect to enter in and be successful within our deal negotiations for for 2020 for 2024. So I think if you look at.

Speaker 11: for 2020, for 2024. So I think if you look at price ranges for drugs that are highly differentiated and first in class in rare conditions, that bring the kind of benefits that... ...and the kind of benefits that are highly differentiated and first in rare conditions, that bring the kind of benefits that are highly differentiated and first in rare conditions.

Josh Smiley: I think, you know, if you look at price ranges for drugs that are highly differentiated and, you know, first in class in rarer conditions that bring the kind of benefits that we believe VYVGART does and that the data supports, you know, you should think about, you know, pricing on a net basis that's, you know, it's gonna be less than the launch $47,000 price. Certainly we see a robust pricing opportunity on a relative basis in China. Of course, we'll have more to disclose on that as we work through the negotiations for next year.

Josh Smiley: I think, you know, if you look at price ranges for drugs that are highly differentiated and, you know, first in class in rarer conditions that bring the kind of benefits that we believe VYVGART does and that the data supports, you know, you should think about, you know, pricing on a net basis that's, you know, it's gonna be less than the launch $47,000 price. Certainly we see a robust pricing opportunity on a relative basis in China. Of course, we'll have more to disclose on that as we work through the negotiations for next year.

Price ranges for for drugs that are highly differentiated and.

First in class in rarer condition that bring the kind of benefits that.

Speaker 11: that we believe Viscart does and that the data supports, you should think about pricing on a net basis that's going to be less than the launch $47,000 price, but certainly we see a robust price.

We believe that guard does and that the data supports.

You should think about.

Pricing.

On a net basis.

It's going to be less than the launch $47000 price, but certainly we see robust pricing opportunity.

Speaker 11: on a relative basis in China. And of course, we'll have more of the disclose on that if we work through the negotiations for next year. I think, as we talked about at the investor day, given the patient volumes that we're talking about, the unmeting being in the benefit that VivGart can bring with first with GMG, followed by CIDP and other hopefully other indications. It helps

On a relative basis and in China and of course, we'll have more to disclose on that as we work through the.

The negotiations for for next year, I think as we talked about at the Investor Day.

Josh Smiley: I think, you know, as we talked about at the Investor Day, given the patient volume that we're talking about, the unmet need and the benefit that VYVGART can bring with, first with GMG, followed by CIDP and other, hopefully other indications, we definitely see a billion-dollar opportunity, and more for this product. We expect, with an NRDL listing at a good price, we expect to see the kind of launch uptake, you know, that you have come to expect from efgartigimod in other markets around the world. We're really excited about that opportunity. I think then moving on to ZEJULA, yeah.

Josh Smiley: I think, you know, as we talked about at the Investor Day, given the patient volume that we're talking about, the unmet need and the benefit that VYVGART can bring with, first with GMG, followed by CIDP and other, hopefully other indications, we definitely see a billion-dollar opportunity, and more for this product. We expect, with an NRDL listing at a good price, we expect to see the kind of launch uptake, you know, that you have come to expect from efgartigimod in other markets around the world. We're really excited about that opportunity. I think then moving on to ZEJULA, yeah.

Given the patient volumes that we're talking about the unmet need and the benefit that they have got can bring with first with gmg, followed by CIBC and other hopeful hopefully other indications.

Speaker 11: We definitely see a billion dollar opportunity and more for this product. We expect with an NRDL listing at a good price, we expect to see this kind of... want to...

We definitely see a billion dollar opportunity and more for this for this product and we expect.

With an NRG listing at a good price.

We expect to see this kind of launch uptake.

Speaker 11: You know that you have come to effect from F-Cortigian Maud in other markets around the world. So we're really excited about that opportunity.

That you have come to expect from.

For FY.

<unk> and other markets around the world. So we're really excited about about that opportunity.

Speaker 11: I think then moving on to the Jula. Yeah, so first, we're squeezed with the performance of the Jula so far this year, current market share, value share across all in the...

I think then moving on to the jeweler, yes, so first.

Josh Smiley: First, you know, we're pleased with the performance of ZEJULA so far this year. Current market share, value share across all indications for ZEJULA in the PARP class is 44%. Given that we're, you know, focused in ovarian and then LYNPARZA's got broader indications, we're clearly the market share leader in ovarian cancer for PARP inhibitors, any way you cut it, whether it's by value or by number of prescriptions. You know, we had said we were on track to become the market share leader, and we have in fact done that. We've seen really good growth in share over the last year. I think in terms of growth, you know, we you know, it's not a surprise.

Josh Smiley: First, you know, we're pleased with the performance of ZEJULA so far this year. Current market share, value share across all indications for ZEJULA in the PARP class is 44%. Given that we're, you know, focused in ovarian and then LYNPARZA's got broader indications, we're clearly the market share leader in ovarian cancer for PARP inhibitors, any way you cut it, whether it's by value or by number of prescriptions. You know, we had said we were on track to become the market share leader, and we have in fact done that. We've seen really good growth in share over the last year. I think in terms of growth, you know, we you know, it's not a surprise.

We're pleased with the performance of the dollar so far this year current market share value share across all indications for <unk>.

Speaker 11: for Zadula in the PAR class is 44%, given that we're focused in Overy and then LAMPARZ has got broader indication.

<unk> and the PARP class is 44%.

Given that we're focused in ovarian and lung pars has got broader indications, where clearly the market share leader in ovarian cancer for PARP inhibitors.

Speaker 11: We're clearly the market share leader, you know, very intensive for part inhibitors in any way you cut it, whether it's by value or by...

Any way you cut it whether it's by value or buy.

Speaker 11: number of prescriptions. So, you know, we had said we were on track to become the market share figure and we haven't backed up. Done that, we've seen really good growth in share over the last last year. I think in terms of growth, you know, we, you know, it's not a surprise, we've known

Number of prescription. So we had said we were on track to become the market share.

Haven't backed.

<unk> done that we're seeing really good growth in share over the last the last year.

I think in terms of growth.

Josh Smiley: We've known for a long time that LYNPARZA will go, you know, will face generic competition at the end of 2024. You know, as you know, we've got a differentiated label. We've got all comers in first line, where LYNPARZA has only got the BRCA mutation. While there will be, of course, some generic impact in second line and maybe in the more targeted first line setting, we still see lots of room for growth for ZEJULA into 2024 and beyond. If you look at our sales today, about 60% of ZEJULA sales are in the first line setting. Penetration in the first line for PARPs is also, you know, somewhere around 60% or so.

Josh Smiley: We've known for a long time that LYNPARZA will go, you know, will face generic competition at the end of 2024. You know, as you know, we've got a differentiated label. We've got all comers in first line, where LYNPARZA has only got the BRCA mutation. While there will be, of course, some generic impact in second line and maybe in the more targeted first line setting, we still see lots of room for growth for ZEJULA into 2024 and beyond. If you look at our sales today, about 60% of ZEJULA sales are in the first line setting. Penetration in the first line for PARPs is also, you know, somewhere around 60% or so.

It's not a surprise we've known.

Speaker 11: for a long time that Limparza will go, we'll face generic competition at the end of 2024. And as you know, we've got a differentiated label. We've got all comers in first line.

For a long time that <unk> will go well.

Generic competition at the end of 2024.

As you know we've got a differentiated label we've got the all comers in first line.

Speaker 11: where Limparza only got the BRAC mutation. So while there will be of course some generic impact in second line and maybe in the more targeted first line setting, we still see lots of room for growth for Zajula into 24 and beyond. If you look at our sales today about 60 percent.

<unk> only got the BRCA mutation so while there will be of course, some generic impact in second line and maybe in the more targeted first line settings, we still see lots of room for growth for us in July .

Into 'twenty four and.

And beyond if you look at our sales today about 60% of.

Speaker 11: of the dual sales are in the first line setting and penetration in the first line for parps is also somewhere around 60% or so. So we've still got a lot of room to grow penetration in the first line setting where there's great data and that's where we'd expect to see the good growth even in the face of generic competition in 2025 and beyond. Thank you and particularly on the 47th.

<unk> sales are in the first line setting.

And penetration in the first line for parts is also somewhere around 60% or so so we still got a lot of room to grow penetration in the first line setting where there is great great data and that's where we'd expect to see the good growth even in the face of generic competition in 2025 and beyond.

Josh Smiley: We've still got a lot of room to grow penetration in the first line setting where there's great data. That's where we'd expect to see the good growth, even in the face of generic competition in 2025 and beyond.

Josh Smiley: We've still got a lot of room to grow penetration in the first line setting where there's great data. That's where we'd expect to see the good growth, even in the face of generic competition in 2025 and beyond.

Michael Yee: Good. Thank you. Particularly on the 47,000 number.

Michael Yee: Good. Thank you. Particularly on the 47,000 number.

Yeah.

Okay. Thank you in particular in the 47 DUC number I appreciate that thank you.

Josh Smiley: Yeah.

Josh Smiley: Yeah.

Michael Yee: Appreciate that. Thank you.

Michael Yee: Appreciate that. Thank you.

Josh Smiley: Yeah.

Josh Smiley: Yeah.

Operator: Thank you.

Operator: Thank you.

Josh Smiley: Next question, Amber.

Josh Smiley: Next question, Amber.

Thank you.

Okay.

Operator: Our next question comes from the line of Anupam Rama from J.P. Morgan. Please ask your question, Anupam.

Operator: Our next question comes from the line of Anupam Rama from J.P. Morgan. Please ask your question, Anupam.

Speaker 8: Next question comes from the line of Anupam Rama from J.P. Morgan. Please ask your question Anupam.

Our next question comes from the line of <unk> Rama from Jpmorgan. Please ask your question in Nepal.

Malcolm Kuno: Hi. Thank you for taking the question. This is actually Malcolm Kuno on for Anupam. Just one question from us. Across your commercial portfolio, where are you seeing the most growth in terms of private pay?

Malcolm Kuno: Hi. Thank you for taking the question. This is actually Malcolm Kuno on for Anupam. Just one question from us. Across your commercial portfolio, where are you seeing the most growth in terms of private pay?

Speaker 10: Hi, thank you for taking the question. This is actually Malcolm Kuno on for Anupam. Just one question from us. Across your commercial portfolio, where are you seeing the most growth in terms of private pay?

Hi, Thank you for taking the questions. This is actually Malcolm kudo on for <unk>.

One question from us across your commercial portfolio, where are you seeing the most growth in terms of private pay.

Josh Smiley: Thanks, Malcolm. I'll ask maybe Jonathan, who's on the line here, to take the question on private pay and how it's impacting our portfolio.

Josh Smiley: Thanks, Malcolm. I'll ask maybe Jonathan, who's on the line here, to take the question on private pay and how it's impacting our portfolio.

Speaker 11: Thanks, Malcolm. I'll ask maybe Jonathan, who's on the line here, to take the question on private pay and how it's impacting our portfolio.

Thanks Mark.

Scott, maybe Jonathan Who's on the line here to take the question on private pay and how it how it's impacting our portfolio.

Jonathan Wang: Yeah. Thanks for the question. For us, the main product since the beginning of the year, which is on private pay, is Optune, because both QINLOCK and NUZYRA, you know, entered into the NRDL as of 1 June. We see pretty good growth for Optune. You know, that growth is coming from an increasing, you know, KOL patient adoption, that is particularly driven by the growth in supplemental health insurance. You know, Optune today is available in something like 68, 70 major cities across China with supplemental insurance. When we started the program in early 2021, the H1 of that year, you fast-forward, you know, almost two years. At the beginning of that, you know, we were low single digits penetration with supplemental insurance.

Jonathan Wang: Yeah. Thanks for the question. For us, the main product since the beginning of the year, which is on private pay, is Optune, because both QINLOCK and NUZYRA, you know, entered into the NRDL as of 1 June. We see pretty good growth for Optune. You know, that growth is coming from an increasing, you know, KOL patient adoption, that is particularly driven by the growth in supplemental health insurance. You know, Optune today is available in something like 68, 70 major cities across China with supplemental insurance. When we started the program in early 2021, the H1 of that year, you fast-forward, you know, almost two years. At the beginning of that, you know, we were low single digits penetration with supplemental insurance.

Speaker 10: Yeah, thanks for the question. So for us, the main product since the beginning of the year, which is on private pay, is off-tune, because both Qinglock and Yuzhira enter into the NIPL as of June 1st.

Yes, thanks for the question.

So for US the main product since the beginning of the year, which is on private pay is auction because about ching lock and use our antenna.

<unk> and IPL as of June .

Speaker 10: So we see pretty good growth for option. That growth is coming from an increasing KOL patient adoption that is particularly driven by the growth in supplemental health insurance.

So we've seen pretty good growth for option.

That growth is coming from and increasing.

Patient adoption.

That is particularly driven by the growth in supplemental health insurance.

Speaker 10: You know, opportunity is available in something like 68, 70, and major cities across China with supplemental insurance.

June today is available is something like 60, 70 major cities across China with supplemental insurance.

Speaker 10: when we started the program in early 2021, in the first half of that year, you fast forward almost two years. So at the beginning of that, we were low single digit penetration with supplemental insurance today, we're about 30% of our total sales, and we project that to continue to grow quite rapidly. So you should expect continued strong growth for options. Thank you. Thank you. Thank you. Appreciate it.

When we started the program in early 2021 in the first half of that year.

You fast forward.

Almost two years so at the beginning of that we were low single digits penetration with supplemental insurance today, we're about 30%.

Jonathan Wang: Today, we're about 30% of, you know, our total sales, and we project that to continue to grow quite rapidly. You know, you should expect continued strong growth for Optune. Thank you.

Jonathan Wang: Today, we're about 30% of, you know, our total sales, and we project that to continue to grow quite rapidly. You know, you should expect continued strong growth for Optune. Thank you.

Our total sales.

That continued to grow quite rapidly.

So you should expect continued strong growth blockchain.

Malcolm Kuno: Great. Thank you. Appreciate it.

Malcolm Kuno: Great. Thank you. Appreciate it.

Great. Thank you appreciate it.

Josh Smiley: Thanks, Jonathan. Amber, next question.

Josh Smiley: Thanks, Jonathan. Amber, next question.

Thanks, Jonathan.

Amber next question.

Operator: Thank you. Our next question comes from the line of Jonathan Chang from Leerink Partners. Please ask your question, Jonathan.

Operator: Thank you. Our next question comes from the line of Jonathan Chang from Leerink Partners. Please ask your question, Jonathan.

Speaker 8: Thank you. I'll make question comes from the line of Jonathan Chang from LeVrink Partners. Please ask your question, Jonathan.

Thank you.

Our next question comes from the line of Jonathan Chang from Leerink Partners. Please ask your question Jonathan.

Speaker 15: Hi, guys. Thanks for taking the questions. Can you please confirm that Zai Lab did not participate in the INNOVATE-3 study? And if that is true, can you provide some color around that? What does that mean for Zai Lab if the INNOVATE-3 study reads out positively? Thank you.

Jonathan Chang: Hi, guys. Thanks for taking the questions. Can you please confirm that Zai Lab did not participate in the INNOVATE-3 study? And if that is true, can you provide some color around that? What does that mean for Zai Lab if the INNOVATE-3 study reads out positively? Thank you.

Speaker 13: Hi, guys, thanks for taking the questions. Can you please confirm that Zilab did not participate in the Innovate 3 study? And if that is true, can you provide some color around that? And what does that mean for Zilab if the Innovate 3 study reads out positively? Thank you.

Hi, guys. Thanks for taking my questions.

Can you please confirm that dry lab did not participate in the innovate three study.

And if that is true can provide some color around that and what does that mean for XI lab innovate <unk> III study reads out positively. Thank you.

Josh Smiley: Rafael, you wanna go ahead with that one?

Josh Smiley: Rafael, you wanna go ahead with that one?

Raphael I'm going to go ahead with that one.

Rafael Amado: Yes. Thank you, Jonathan, for the question. You are correct. Zai Lab did not participate on INNOVATE-3. Just as a reminder, this is a study, a survival study, of TTFields plus Taxol versus Taxol alone in patients with platinum-resistant ovarian cancer. It's supposed to report soon. We did participate on METIS, which is a brain metastasis from lung cancer study, as well as PANOVA-3. You may have heard, Novocure reported that the study is continuing to completion of survival after a DMC review. With regards to the consequences were the study to be positive, which hopefully it will be, we have options to register with an NMPA for the indication of ovarian cancer.

Rafael Amado: Yes. Thank you, Jonathan, for the question. You are correct. Zai Lab did not participate on INNOVATE-3. Just as a reminder, this is a study, a survival study, of TTFields plus Taxol versus Taxol alone in patients with platinum-resistant ovarian cancer. It's supposed to report soon. We did participate on METIS, which is a brain metastasis from lung cancer study, as well as PANOVA-3. You may have heard, Novocure reported that the study is continuing to completion of survival after a DMC review. With regards to the consequences were the study to be positive, which hopefully it will be, we have options to register with an NMPA for the indication of ovarian cancer.

Speaker 5: Yes, thank you, Jennifer, for the question. You are correct. I didn't know or dissipate on Inu-A3. This is a reminder, this is a survival study of TTC fields plus Tatsuo versus Tatsuo alone in patients with climate consistent awareness cancer. And it's supposed to report

Yes.

Thank you Jonathan for the question.

You are correct.

I did not participate on innovate three.

And just as a reminder.

Study a survival study.

Of.

TT fields.

Plus.

So versus Texas alone in patients with platinum resistant ovarian cancer.

And it's supposed to report.

Speaker 5: We did participate on medias, which is a very metastasis from lung cancer study. As well as panoeuvres three, you may have her Novocere reported that the study is continuing to completion of survival after an IDMC review.

Soon we did participate on <unk>, which is a brain metastases from lung cancer study.

As well as Panama City, you may have for.

<unk> reported that the study is continuing to completion of survival astronaut DMC review.

Speaker 5: And with regards to the consequences where the study to be positive, which hopefully will be, we have options to register with an MPA for the indication of ovarian cancer.

And with regards to.

The consequence is where the study to be positive, which hopefully will be.

We have options to register with an NPA or the indication of ovarian cancer.

Rafael Amado: The most logical way to go is, after consultation with an MPA, to do a bridging study. Obviously, there's no PK study 'cause this is a device. To do a bridging study and submit that together with the global package of INNOVATE-3 for approval, the equivalent of pre-market approval in the United States in China. We were eagerly awaiting the results as well, and we will make the decision as we see them.

Rafael Amado: The most logical way to go is, after consultation with an MPA, to do a bridging study. Obviously, there's no PK study 'cause this is a device. To do a bridging study and submit that together with the global package of INNOVATE-3 for approval, the equivalent of pre-market approval in the United States in China. We were eagerly awaiting the results as well, and we will make the decision as we see them.

Speaker 5: And the most logical way to go is to, after consultation with an MPA.

<unk>.

Most logical way to go to after consultation with an NDA.

Speaker 5: is to do a bridging study. Obviously, there's no PK study because this is a device, is to do a bridging study and to make that together with the global package of innovate three for approval, the equivalent of a pre-marketing approval in the United States.

To do a bridging study, obviously theres no PK study.

<unk> is to do a bridging study.

So that together with a global package innovate three.

Four.

Approval, the equivalent of a pre market approval in the United States.

Speaker 5: So, we are eagerly awaiting the response as well, and we will make the decision as we see them. Thank you.

In China, So we well.

Well eagerly awaiting the results as well and we will make the decision.

We see them.

Speaker 15: Got it. Thank you.

Jonathan Chang: Got it. Thank you.

Okay got it thank you.

Yajing Chen: Our next question comes from the line of Jason Liu from Credit Suisse. Please ask your question, Jason.

Yajing Chen: Our next question comes from the line of Jason Liu from Credit Suisse. Please ask your question, Jason.

Okay.

Speaker 8: Next question comes from the line of Jason Lillap from Credit Suisse. Please ask your question Jason.

Our next question comes from the line of Jason <unk> from Credit Suisse. Please ask your question Jason.

Speaker 16: Two questions from my end. One on just overall kind of policy. We do know that for national reimbursement, that there has been kind of changes in rules lately as well. Going forward, based on some of these renewal rule updates, how does that impact Zai Lab's products and products that may be up for renewal going forward? Second question just on the strategic plan for five years. We've mentioned again that the breakeven target is by 2025. Was wondering if there can be any more color as to how we plan to meet that target. Thanks.

Jason Liu: Two questions from my end. One on just overall kind of policy. We do know that for national reimbursement, that there has been kind of changes in rules lately as well. Going forward, based on some of these renewal rule updates, how does that impact Zai Lab's products and products that may be up for renewal going forward? Second question just on the strategic plan for five years. We've mentioned again that the breakeven target is by 2025. Was wondering if there can be any more color as to how we plan to meet that target. Thanks.

Speaker 14: Okay, two questions from my end. One on just overall kind of policy, we do know that for...

Two questions from my end one on just overall kind of policy, we do know that for.

Speaker 14: National reimbursement that there had been kind of changes in rules lately as well. So going forward, it's not some of these renewal rules updates. How does that impact size products and products that may be up for renewal going forward?

National reimbursement that there has been kind of changes in real estate, we as well so going forward based on some of these renewal updates how does that impact <unk> products and products that may be up for renewal going forward and then second question just on the strategic plan for five years.

Speaker 14: And then second question just on the circuitial plan for five years.

Speaker 14: We've mentioned again that the breakeven target is by 2025. So, I was wondering if there can be any more color as to how we plan to meet that target.

We've mentioned again that the breakeven target is by 2025% so.

I was wondering if there can be any more color as to how we plan.

To meet that target. Thanks.

Josh Smiley: Thanks, Jason. I think on NRDL, you know, we've been pretty clear that the renewal policies are, I think, very favorable, you know, good transparency, should yield lower reductions on a biannual basis. Samantha, I don't know if you wanna make any comments on NRDL or policy environment more generally. I think we may have,

Josh Smiley: Thanks, Jason. I think on NRDL, you know, we've been pretty clear that the renewal policies are, I think, very favorable, you know, good transparency, should yield lower reductions on a biannual basis. Samantha, I don't know if you wanna make any comments on NRDL or policy environment more generally. I think we may have,

Speaker 11: Thanks, Jason. I think on NRDL, we've been pretty clear that the renewal policies are, I think, very favorable good transparency should yield lower reductions on a, you know, on a biannual basis. To me, as I don't know if you want to make any comments on NRDL or policy environment in more general.

Thanks, Jason I think on NR Dl.

We've been pretty clear that the.

<unk> policies are I think very favorable.

Good transparency.

Should yield lower reductions on a on a biannual basis.

Samantha I don't know if you want to make any comments on every deal or policy environment more generally.

Okay.

Speaker 11: I think we may have a... Oh, okay. Okay, you got it? Okay, you got it. I actually have a thunderstorm on my background.

Samantha Du: Oh, okay.

Samantha Du: Oh, okay.

I think we may have.

Josh Smiley: Okay, you got it? Okay, got it. Okay.

Josh Smiley: Okay, you got it? Okay, got it. Okay.

Samantha Du: Yeah.

Samantha Du: Yeah.

Josh Smiley: Thanks.

Josh Smiley: Thanks.

Samantha Du: I actually have a thunderstorm on my background.

Samantha Du: I actually have a thunderstorm on my background.

Got it okay got it.

I am actually have all have a thunderstorm on my background.

Josh Smiley: Ah.

Josh Smiley: Ah.

Samantha Du: If you cannot hear me better, I'm sorry about that. Yes, I think I agree with Josh. It's actually, especially in terms of we have like new indications coming in with an updated NRDL guidance will really help us to say that, you know, the price we initially you know developed. There are other things like the questions raised about the opportunities, the new indications. Some of them we participated, some we don't. Just to be clear, even the first approval in China, and that data was based on the US data. There are a lot of potentials based on the unmet needs. We need to work with the regulator locally.

Samantha Du: If you cannot hear me better, I'm sorry about that. Yes, I think I agree with Josh. It's actually, especially in terms of we have like new indications coming in with an updated NRDL guidance will really help us to say that, you know, the price we initially you know developed. There are other things like the questions raised about the opportunities, the new indications. Some of them we participated, some we don't. Just to be clear, even the first approval in China, and that data was based on the US data. There are a lot of potentials based on the unmet needs. We need to work with the regulator locally.

Speaker 2: I cannot hear me better, I'm sorry about that. So yes, I think I agree with Josh. We are, it's actually especially in terms of we have like new indications coming in with an updated the NARDO guidance. We don't really help us to say that, you know, the price we are initially in this development.

Thank you cannot hear me better I'm, sorry about that so, but yes I agree.

With Josh.

It's actually especially in terms of rehab.

Like many indications coming along with an updated pool.

Knock me all our guidance really help us.

Okay.

Alright.

Well, mostly.

So that alone.

Speaker 2: But there are other things like the questions raised about for the, you know, for the opportunity, the new indication. Some of them we participated, some we don't. But just be clear, even the first approval in China, that data was based on the U.S. data. So there's a lot of potential based on the MIT needs. We need to work with the regulator locally.

But there are other things that I thought the questions raised about full.

So the opt to sell new indications.

Some of them they participated some we don't.

The clear even the first approval in China and that was based on that.

That data was based on the U S and so there's lots of potential based on the unmet needs we need to work with the regulator low quick so.

Samantha Du: That's just a few quick comments. Thank you all.

Speaker 2: So just that just for you comments, quick comments, thank you all.

Samantha Du: That's just a few quick comments. Thank you all.

That just comment quick comments. Thank you.

Josh Smiley: Thanks, Samantha. Jason, on your second question around the five-year strategic plan, and our cash position and profitability. First, we're certainly on track for the guidance that we gave out in June at our Investor Day, which is 50% compound annual growth rate in sales from 2023 to 2028, profitability by the end of 2025, and of course, increasing margins from there on. I think if you look at the quarter, I think you can see you know, the beginnings of that, you know, greater than 50% growth in sales, and good expense management. Of course, that's the formula that will lead to profitability in 2025 and beyond.

Josh Smiley: Thanks, Samantha. Jason, on your second question around the five-year strategic plan, and our cash position and profitability. First, we're certainly on track for the guidance that we gave out in June at our Investor Day, which is 50% compound annual growth rate in sales from 2023 to 2028, profitability by the end of 2025, and of course, increasing margins from there on. I think if you look at the quarter, I think you can see you know, the beginnings of that, you know, greater than 50% growth in sales, and good expense management. Of course, that's the formula that will lead to profitability in 2025 and beyond.

Speaker 11: Thank you, Samantha. And Jay is from your second question around the five year.

Thanks Samantha.

And Jason on your second question around the five year strategic plan and.

Speaker 11: strategic plan and our cash position and profitability. First, we're certainly on track for the guidance that we gave out in June at our investor day, which is

Our cash position and profitability first work.

We're certainly on track for the guidance that we gave out in June at our Investor Day, which is a 50% compound annual growth rate in sales from 23% to 28 <unk>.

Speaker 11: 50% compound annual growth rate it sales from 23 to 28 profitability by the end of 2025 and of course increasing margins from there on and I think if you look at the quarter I think you can see the you know the beginnings of that 50% you know greater than 50% growth in sales

Profitability by the end of 2025.

And of course, increasing margins from there on and I think if you look at the quarter.

I think you can see the beginnings of that 50% greater than 50% growth in sales.

Speaker 11: and good expense management. Of course, that's the formula that will lead to profitability in 2025.

And good expense management.

Of course.

Formula that will lead to profitability in 2025.

Speaker 11: and beyond. I think as if you look at our cash position, our burn.

Josh Smiley: I think if you look at our cash position, our cash burn, it's coming down significantly, so we feel good about where we are from that perspective, and I think have plenty of capacity to invest in all of our new launches, starting with efgartigimod, this year, continue to pursue good targeted business development opportunities. I think we've got plenty of capacity within the R&D line to finish the studies that we're participating in now for registration and be able to bring, you know, new ones on board within that same envelope of R&D spend. I'll ask Yajing Chen to make a couple comments specifically about the balance sheet and cash position.

Josh Smiley: I think if you look at our cash position, our cash burn, it's coming down significantly, so we feel good about where we are from that perspective, and I think have plenty of capacity to invest in all of our new launches, starting with efgartigimod, this year, continue to pursue good targeted business development opportunities. I think we've got plenty of capacity within the R&D line to finish the studies that we're participating in now for registration and be able to bring, you know, new ones on board within that same envelope of R&D spend. I'll ask Yajing Chen to make a couple comments specifically about the balance sheet and cash position.

And beyond I think if you look at our cash position and burn it is coming down significantly. So we feel good about where we are from that perspective, and I think have plenty of capacity to invest in all of our new launches starting with <unk>. This year continue to pursue good.

Speaker 11: it's coming down significantly. So we feel good about where we are. I'm not perfect even I think have plenty of capacity to invest in all of our new launches starting with that partridge of mod this year. Continue to pursue good targeted business development opportunities. And I think we've got plenty of capacity within the R&D line to finish the studies that we're participating in now for registration and be able to bring on board within that same envelope of R&D spend. I'll ask you being a chair to make a couple comments specifically about the balance.

Targeted business development opportunities and I think we've got plenty of capacity within the R&D line to finish the studies that were participating in now for registration and be able to bring new ones onboard within that same envelope of R&D spend I'll ask Dr. Bing Chen to make a couple comments.

Specifically about the balance sheet cash position.

Speaker 11: Gotcha.

Yajing Chen: Thank you, Josh. Yeah. We have a very strong sort of position in terms of a cash flow right now. We have $876 million of cash right now. For the next few years, the way that we're looking at the sort of productivity gain is, first of all, the revenue growth, 50% year over year. That's a huge leverage for us to go down the path to profitability. Secondly, when we look at our sort of a commercial organization, there's a lot of new launches that there are a lot of synergies for us to shoot for, right? We're going to optimize our commercial growth in the next five years. When we look into all the expenditures in the R&D side, we have 17 pivotal trials.

Yajing Chen: Thank you, Josh. Yeah. We have a very strong sort of position in terms of a cash flow right now. We have $876 million of cash right now. For the next few years, the way that we're looking at the sort of productivity gain is, first of all, the revenue growth, 50% year over year. That's a huge leverage for us to go down the path to profitability. Secondly, when we look at our sort of a commercial organization, there's a lot of new launches that there are a lot of synergies for us to shoot for, right? We're going to optimize our commercial growth in the next five years. When we look into all the expenditures in the R&D side, we have 17 pivotal trials.

Speaker 1: Thank you, Josh. Yeah, so we have a very strong sort of a position in terms of a cash.

Thank you guys. Yeah. So we have very strong set of acquisition in terms of our cash level right. Now so we are not at all.

Speaker 1: So we are in $176 million right now of the patch. For the next few years, the way that we're looking at those productivity things, is first of all, the revenue growth 60% of your year, that's a huge leverage for to go down the path to profitability. Secondly, when we look at our...

Right now.

Yes.

Yes, the way that we're looking at those.

Typically it's first of all does that mean growth cyclical Danielle yes.

<unk> leverage.

You go down the path to profitability secondly, when we look at our.

Speaker 1: sort of a commercial organization, there are a lot of new launches that there are a lot of images to shoot for. So we're going to optimize our commercial growth in the next five years.

So look our commercial organization a lot of new launches.

Please go ahead.

Tissue.

So we're going to optimize our commercial growth in the next five years.

Speaker 1: And then when we look into all the expenditures in R&D sites, we have 17 pivotal trials. We see a slight increase in R&D expenses this year, but that hasn't continued for the next two years. So we are going to continue to drive productivity in R&D organizations.

Now when we look into all the commentary.

The site, we have 17 pivotal trials.

Yajing Chen: We see slight increase in R&D expenses this year, but that's going to continue for the next two years. We are going to continue to drive productivity in R&D organization. On the other R&D side, the infrastructure, we already have a strong infrastructure right now. We don't expect any growth in that, so we're gonna leverage that. With all that, you know, very, very high revenue growth, and much, much smaller sort of expenditure expansion. That's how we get to the profitability by the end of 2025.

Yajing Chen: We see slight increase in R&D expenses this year, but that's going to continue for the next two years. We are going to continue to drive productivity in R&D organization. On the other R&D side, the infrastructure, we already have a strong infrastructure right now. We don't expect any growth in that, so we're gonna leverage that. With all that, you know, very, very high revenue growth, and much, much smaller sort of expenditure expansion. That's how we get to the profitability by the end of 2025.

By increasing our R&D focus.

How can continue for the next two years.

We have continued to drive productivity.

Speaker 1: And on the other DNA side, the infrastructure, we already have a strong infrastructure right now. We don't expect any growth in that, so we're going to be loving that.

<unk> been strong.

On the other side the infrastructure, we already have very strong infrastructure that now we don't expect any growth in that but we're going to leverage that.

Speaker 1: So we all got, uh, very very high in Fab ??? cans and new

So with all of that.

High revenue growth.

Speaker 1: and much much smaller sort of a signature extension and that's how we get to the profitability by the end of the presentation.

And much much smaller.

Thank you Cheng.

That's how we got the profitability by the end of <unk>.

Josh Smiley: Thank you, Yajing, and thanks, for the question. I think at this point I'll turn it back over to Samantha to close out the call.

Josh Smiley: Thank you, Yajing, and thanks, for the question. I think at this point I'll turn it back over to Samantha to close out the call.

Speaker 15: Thank you, Yajing, and thanks for the question. I think at this point, I'll turn it back over to Samantha to close out the call. Sure.

Thank you Jim and thanks.

For the question.

At this point I'll turn it back over to Samantha close out the call.

Samantha Du: Sure. Operator, do you want to say something? Okay. Thank you, Josh. 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 2023. Operator, you may now disconnect this call.

Samantha Du: Sure. Operator, do you want to say something? Okay. Thank you, Josh. 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 2023. Operator, you may now disconnect this call.

Sure.

Operator, do you want to say something.

Speaker 2: Okay, thank you Josh. I want to thank everyone. We'll take you in the time for Joe and not down the call today

Okay. Thank you Josh.

I want to thank everyone for taking the time to join us on the call today.

Speaker 2: We appreciate your support and look forward to updating you again after third quarter of 2020-23. Upreader, you may now disconnect this call.

We appreciate your support and look forward to updating you again after the third quarter of 2023.

You may now disconnect this call.

Yajing Chen: This concludes today's conference call. Thank you for participating. You may now disconnect.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

Speaker 7: This concludes today's conference call. Thank you for participating. You may now disconnect.

This concludes today's conference call. Thank you for participating you may now disconnect.

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Q2 2023 Zai Lab Limited Earnings Call

Demo

Zai Lab

Earnings

Q2 2023 Zai Lab Limited Earnings Call

ZLAB

Tuesday, August 8th, 2023 at 12:00 PM

Transcript

No Transcript Available

No transcript data is available for this event yet. Transcripts typically become available shortly after an earnings call ends.

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