Beyond this, we have a series of other potential approvals, including repotrectinib and SUL-DUR later this year, followed by a series of other new product indications, including efgartigimod in CIDP, bemarituzumab and KarXT. Each of these products has the potential to meaningfully enhance the growth of our business. We are also already deeply committed to building our global pipeline by adding new assets through both our internal discovery efforts and external opportunities, and I look forward to providing updates on our progress in this regard throughout the year. And of course, we'll maintain disciplined capital allocation practices, as we strive to achieve profitability. As we execute on these corporate objectives, we expect to deliver value not only to patients, but also to our shareholders.

Thank you for your support as we continue on our journey of innovation and growth together. And with that, I'll pass the call over to Josh. Josh?

Josh Smiley: Thank you, Samantha, and thank you, everyone, for joining the call today. Zai Lab delivered strong full year revenue growth of 25% year-over-year and 31% on a constant exchange rate basis, driven by robust volume growth across our existing product portfolio and the launch of VYVGART. These revenue increases were partially offset by an increase in sales rebates, both in Q1 of 2023 in connection with new listings for our product on China's 2022 National Reimbursement Drug List or NRDL, and in Q4 of 2023 in connection with new and renewed NRDL listings for our products on China's 2023 NRDL. A pivotal achievement for us was the approval and subsequent launch of VYVGART in September, followed by its inclusion in the NRDL, which became effective at the beginning of this year.

Throughout the fourth quarter, we implemented comprehensive commercial strategies to drive awareness and adoption of VYVGART, and we entered 2024 with considerable momentum. I'm also pleased to announce that in 2023, we achieved our goal of having net product revenue exceed the cost of sales and sales and marketing expenses for our commercial products, which we refer to as commercial profitability. Our commitment to financial prudence remains steadfast as we work towards achieving and maintaining profitability. Lastly, we made substantial progress on key clinical development programs such as efgartigimod in CIDP and KarXT in schizophrenia, while further enriching our global pipeline with the introduction of a next-generation DLL3 ADC. In 2023, we announced our five-year strategic plan aimed at positioning Zai Lab as a leading global biopharmaceutical company characterized by substantial revenue growth, achievement of profitability and a strong global pipeline.

This strategic vision is underpinned by three corporate objectives. First, we are focused on accelerating top line growth. With a strong foundation in place supported by both new product approvals and label expansions within our existing portfolio, we anticipate substantial revenue growth in the coming years. By 2028, we aim to have a significantly larger commercial portfolio with the launch of potential blockbusters such as VYVGART leading the way. Subsequent potential launches include SUL-DUR later this year and TIVDAK, bemarituzumab and KarXT in 2025 and beyond. Such launches would further drive revenue growth with our projections exceeding $2 billion in 2028, reflecting our estimated five-year compound annual growth rate of 50%. Furthermore, we are committed to building our global portfolio through internal discovery initiatives and strategic business development endeavors.

Our goal is to advance at least one global IND into clinical trials annually as we continue to evaluate and pursue synergistic global and regional business development opportunities, leveraging Zai Lab's reputation as a trusted brand and preferred strategic partner. As we continue to grow and develop our commercial portfolio and pipeline, we remain focused on scaling with purpose, and this brings us to our third objective, which is to achieve corporate profitability by the end of 2025. To realize this objective, we will continue to enhance efficiency and productivity, prioritize research and development initiatives and execute cost optimization strategies. Our existing infrastructure is agile and sized to support multiple new launches. We maintained a robust reserve of cash and cash equivalents of $807.6 million as of the end of 2023, providing ample financial resources to sustain our operations through profitability and beyond.

Now, I will briefly review the performance of each of our commercial products and our expectations for 2024. ZEJULA maintained its position as the leader in hospital sales for PARP inhibitors in ovarian cancer in China, exhibiting growth in the fourth quarter and the entire year. In 2024, we will continue to focus on driving further growth in the first-line setting and extending the duration of therapy. In 2023, QINLOCK and the IV formulation of NUZYRA joined ZEJULA on the NRDL. And these listings help drive substantial sales increases for these products. We expect this positive momentum to continue, supplemented by the additional listing for the oral formulation of NUZYRA in January 2024. As OPTUNE is a medical device and not eligible for NRDL inclusion, we are focused on expanding access and improving affordability for this important treatment through commercial health insurance coverage.

Overall, we anticipate year-over-year revenue growth in 2024 for these four products in aggregate to be comparable to that of 2023. Turning now to the recent launch of VYVGART. I want to take a moment to acknowledge the tremendous effort of our medical and regulatory and commercial teams behind VYVGART. We were able to reach important milestones at a swift pace achieving our best case scenario with regards to the timing for approval, launch and NRDL listing. We are pleased to see the regulatory authorities recognize the innovation of VYVGART and its substantial clinical benefit to patients living with generalized myasthenia gravis or gMG. In China, where there are over 170,000 patients with gMG, many patients endure residual symptoms or inadequate treatment, making everyday tasks challenging and unpredictable.

The scarcity of innovative therapies, the persistent shortage of IVIg therapy and the chronic and progressive nature of the disease, can present a formidable challenge for both patients and healthcare providers alike, further underscoring the significance of the VYVGART's approval. Throughout the fourth quarter, our primary focus was on strategically targeting key hospitals and fostering awareness while delivering timely support to physicians and patients alike. And we made great progress. As of December, we have successfully engaged 100% of our top 200 target hospitals and over 90% of our top 100 physicians integrated VYVGART into their treatment protocols. Based on a survey of 250 physicians, awareness of VYVGART grows from 54% to 72% following four months of promotion, and we continue to see this rise.

From launch in September through the end of the year, we estimate that nearly 1,000 patients were treated with VYVGART. Turning now to more recent updates on the launch. VYVGART's listing on the NRDL became effective on January 1 this year with a price of $800 a vial or $32,000 per patient per year based on clinical study usage. We estimate that in January 2024 alone, nearly 1,000 new patients were treated with VYVGART, indicating promising progress at this early stage of launch. This demand is being driven by an unmet need in the treatment of gMG, a willingness of physicians to adopt VYVGART into treatment protocols and increased patient access as hospitals add VYVGART to their formularies. We are very pleased with the progress achieved thus far with the launch of VYVGART, and we anticipate sales to exceed $70 million in 2024.

Our strategic focus for the year will be to expand outreach to approximately 1,000 hospitals with a concentrated effort on accelerating VYVGART listing at top-tier hospitals. Already, as of the end of January, our team has engaged 100% of our top 600 hospitals in person. Supported by our dedicated sales force of approximately 150 reps, we anticipate robust coverage to facilitate this expansion. Additionally, pending regulatory approval, we expect to launch of VYVGART's subcutaneous formulation for gMG later this year, which will offer enhanced dosing flexibility for physicians and patients. We're also excited about potential indication expansion for VYVGART. This year, we expect to submit a supplemental Biologics License Application or sBLA in China for CIDP, which presents another substantial growth opportunity.

This marks an exciting period for Zai Lab and an important year of execution for our team. And with that, I would like to pass the call to Rafael, who will provide an update on our oncology pipeline. Rafael?

Rafael Amado: Thank you, Josh. Let me begin by highlighting some of the key progress updates in our oncology pipeline since our last earnings call, along with our next steps. Starting with bemarituzumab, our FGFR2b inhibitor in collaboration with Amgen. We are enrolling in both FORTITUDE-101 and FORTITUDE-102 Phase 3 study, evaluating bemarituzumab in FGFR2b-positive gastric cancer as a doublet therapy with chemo and a triplet with chemo and a checkpoint inhibitor, respectively. We expect both studies to enroll well, and we're eager to introduce this much-needed therapy to China, where we estimate an incidence of 126,000 FGFR2b-positive gastric cancer patients each year. Next, our Tumor Treating Fields franchise. In January 2024, our partner, NovoCure, announced that the FDA had accepted the filing of their pre-market approval application for TTFields in non-small cell lung cancer, following progression on or after platinum-based therapy and a regulatory decision is expected in the second half of this year.

In China, we expect to file a marketing authorization application for TTFields in this indication later this year. We also expect two pivotal readouts for Tumor Treating Fields, including in brain metastases from non-small cell lung cancer and in pancreatic cancer, both in the first-line setting. Also in lung cancer, repotrectinib is currently under priority review for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer in China. The filing was based on the results from the pivotal TRIDENT-1 study, which were published in the New England Journal of Medicine in January this year. Findings demonstrated the potential of repotrectinib to overcome limitations of first-generation tyrosine kinase inhibitors in terms of responses and durability in ROS1- resistant mutation.

We look forward to a potential regulatory approval and launch this year to bring this best-in-class ROS1/TRK inhibitor to patients in need in China. Now moving on to adagrasib. We will continue to accelerate the regulatory pathway for second-line non-small lung cancer monotherapy by leveraging the global data package for the FDA approval, the ongoing PK study in China and the global confirmatory KRYSTAL-12 study with Zai Lab joined in July 2022, and we await the results for a filing submission in China this year. In addition, our partner, BMS, announced this month that the FDA has accepted its supplemental NDA for priority review for adagrasib in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer with a PDUFA goal date of June 21, 2024.

For this indication, adagrasib has the potential to be the first to market KRASG12C inhibitor in China. We completed enrollment in the global Phase 3 KRYSTAL-10 confirmatory study in 2023. Lastly, for TIVDAK, we have participated in the confirmatory Phase 3 innovaTV-301 global trial in second-line cervical cancer and continue an extension portion in China, and we intend to file a new drug application or NDA in China this year. In addition to our late-stage programs, our DLL3 ADC ZL-1310 has shown promising preclinical data and is progressing through a global Phase 1 study in relapsed and refractory small cell lung cancer, who has progressed after platinum-based treatment in the United States and in China. In March, we will present the preclinical data at the European Lung Cancer Congress in Prague.

And depending on the dose escalation level, we could potentially see early clinical results at the end of 2024 or early 2025. We're also selecting internally discovered product candidates to achieve our goal of generating at least one IND per year, and we continue to assess external opportunities to introduce a new product in development this year. And now, I will turn the floor over to Dr. Harald Reinhart to discuss the progress in our autoimmune, infectious disease and neuroscience therapeutic areas. Harald?

Harald Reinhart: Thank you, Rafael. This is truly a very exciting time for our neuroscience, autoimmune and infectious diseases or NSAID franchise, as we made significant progress in the past year advancing our pipeline. Starting with VYVGART or efgartigimod. Beyond what Josh shared about the progress for gMG, we are excited about the positive data for treating patients with CIDP or chronic inflammatory demyelinating polyneuropathy. There are an estimated 50,000 patients diagnosed with CIDP in China. And today, only a small fraction are able to achieve remission on their current standard of care, and the majority of patients continue to be burdened with symptoms that can have a debilitating impact on quality of life. Existing treatment options are limited and quite problematic given the general reliance on long-term steroid or chronic immunoglobulin therapy.

In China, the situation has worsened due to the persistent shortage of IVIg therapy. Our partner, argenx, announced this month that the FDA had accepted for priority review the sBLA for subcu administered VYVGART Hytrulo in CIDP. It was granted a PDUFA goal date of June 21 of this year. We plan to submit an sBLA to the NMPA in China for this indication in the first half of 2024. In addition, our sBLA for efgartigimod subcu in gMG is under regulatory review in China with potential NMPA approval this year. This approval would give patients flexibility in treatment with either IV or more convenient subcu dosing. Efgartigimod subcu has the advantage of simplicity and speed as administration takes only 30 to 90 seconds for a single dose. We see significant potential fo efgartigimod across multiple additional indications, and we will continue to work with our partner argenx on indication expansion.

For example, we expect to join them in the registrational study of efgartigimod in thyroid eye disease or TED in Greater China in the second half of this year. Turning to KarXT. This is the first-in-class antipsychotic, combining a centrally active muscarinic agonist called xanomeline with a peripheral antagonist called trospium, which we are developing with our partner Karuna for patients with acute schizophrenia. In November 2023, the FDA accepted Karuna's NDA for KarXT for the treatment of schizophrenia in adults with a PDUFA goal date of September 26, 2024.We continue to enroll patients in the registrational bridging study in Mainland China, and we expect to complete enrollment this year. We believe that KarXT could become an important new treatment option China, where more than 8 million people are living with schizophrenia and where severe under treatment and inadequate symptom improvement or even disease control persists despite currently available antipsychotics.

We have yet another substantial opportunity for KarXT, which is for the treatment and prevention of psychosis in Alzheimer's disease patients or ADP for short. There are approximately 8 million people with Alzheimer's disease in China and about 45% of these patients display psychotic symptoms. We believe that there is a significant unmet need for patients with ADP or Alzheimer's disease with psychosis in China as there are no approved treatments. Karuna initiated the Phase III ADEPT-2 and ADEPT-3 clinical trials in the third quarter of 2023, and we plan to participate in both studies in Greater China in mid-2024.Regarding our infectious diseases portfolio, sulbactam-durlobactam or SUL-DUR is a treatment for hospital-acquired and ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii.

In China, there are 240,000 to 300,000 cases of Acinetobacter infections annually, with the majority of strains being carbapenem-resistant. Latest countrywide surveillance data from China indicated a rise in overall resistance to approximately 80%. With limited treatment options for these patients, the mortality rate is around 43%, even with the best available therapy and care. The WHO has listed Acinetobacter baumannii as the number one problem pathogen and the high incidence in China has prompted the Chinese government to prioritize efforts to combat this multidrug-resistant bacteria. Our NDA submission is under priority review, and we are looking forward to a potential approval later this year. Last, not least, ZL-1102, our IL-17 Humabody for the topical treatment of chronic plaque psoriasis or CPP is in the final stages of preparation for a global Phase II dose-finding trial, and we intend to initiate the study in mid-2024.

So plenty of exciting progress within our NSAiID portfolio, and I look forward to providing updates at our next earnings call. And now, Yajing will provide an overview of our financial results. Yajing?

Yajing Chen: Thank you, Harald. Now, I will discuss our full year financial results compared to the prior year. In 2023, total net product revenues grew to $266.7 million. This represents year-over-year growth of 25% or 31% on a constant currency basis. Our revenue growth was driven by increased sales volumes and the launch of VYVGART, partially offset by an increase in our sales rebates to distributors resulting from price reductions in connection with additional NRDL listings. Sales rebates in connection with NRDL listings rose to $13 million for 2023. These NRDL listings play a crucial role in maintaining patient access to our existing products on NRDL, while significantly expanding access for our new products. Growth was also negatively impacted by the temporary effects on the hospital and physician practices that resulted from industry-wide anti-corruption enforcement efforts in China in the second half of the year.

Now, looking at each individual product, the ZEJULA net product revenue increased 16% year-over-year to $168.8 million in its third year under NRDL, driven by increased hospital sales in first-line ovarian cancer and a duration of treatment improvement, partially offset by an increase in sales rebates in the fourth quarter in connection with the renewal of the NRDL listing for ZEJULA as a maintenance treatment. VYVGART net product revenue was $10 million following the launch in China in September 2023. We successfully negotiated for VYVGART's first listing on the NRDL with pricing that took effect on January 1, 2024. OPTUNE, net product revenue was relatively flat year-over-year at $47 million, as continued growth in supplemental insurance coverage was offset by the disruption in hospital and physician practices resulting from anti-corruption efforts.

QINLOCK grew 29% year-over-year to $19.2 million and NUZYRA increased 316% to $21.7 million. This growth was supported by the inclusion of QINLOCK and the IV formulation of NUZYRA in the NRDL in the first quarter of 2023, partially offset by sales rebates in connection with this NRDL listing, as well as sales rebates in the fourth quarter in connection with the inclusion of the oral formulation of NUZYRA, which became effective in January 2024. Turning now to our expenses, research and development expenses declined $21 million to $265.9 million, primarily due to decreased upfront and milestone payments for our license and collaboration agreement, partially offset by an increase in personnel compensation and related costs. Selling, general and administrative expenses grew $23 million to $281.6 million, primarily due to higher general selling expenses to support the launch of VYVGART, partially offset by a decrease in professional services fee.

Both R&D and SG&A expenses significantly declined as a percentage of revenue, and we expect this trend to continue as a result of our growing revenues and our ongoing cost and efficiency initiatives. Zai Lab reported a net loss of $334.6 million for 2023, which improved by $108 million versus prior year. The decrease in net loss reflects our continued progress towards profitability, primarily due to our product revenue growing faster than net operating expenses, as well as increased interest income and decreased foreign currency loss. We are in a strong financial position, ending the year with a cash position of $807.6 million, compared to $1 billion as of December 31, 2022. Based on our operating plan and our anticipated revenue growth, we expect to be able to fund our business through profitability.

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

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