Zai Lab Ltd Q1 FY2021 Earnings Call

Hello, ladies and gentlemen, thank you for standing by, and welcome to Zai Lab's First Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Billy Cho, Chief Financial Officer of Zai Lab, who will make introductory comments.

Good morning, and welcome to Zai Lab's first quarter 2021 financial results and corporate update conference call. Earlier this morning, Zai Lab issued a press release providing the details of the company's financial results for the three months ended March 31, 2021, as well as product highlights and corporate updates. The press release is available in the Investor Relations section of the company's corporate website. Today's call will be led by Dr. Samantha Du, Zai Lab's Founder, Chairperson and Chief Executive Officer. She will be joined by Tao Fu, Chief Strategy Officer, who will provide more details on our recent commercial and pipeline progress; Jonathan Wang, Head of Business Development; Dr. Alan Sandler, President, Head of Global Development, Oncology; and Dr. Harald Reinhart, Chief Medical Officer for Autoimmune and Infectious Diseases, who will also be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, Zai Lab will be making certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including our business plans and objectives and the timing and success of our clinical trials, regulatory applications and commercial launches. Such forward-looking statements are not guarantees of future performance, and therefore, you should not put undue reliance upon them. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. I refer you to our SEC filings for a discussion of risk factors that could cause our actual results to differ materially from those discussed today. At this time, it is my pleasure to turn the call over to Zai Lab's Founder, Chairperson and Chief Executive Officer, Dr. Samantha Du.

Thank you, Billy. Hello, everyone, and thank you all for joining us. On this call, I'll discuss some of the highlights from the first quarter to provide remarks as to why we believe Zai Lab's future has never been brighter. We are off to a great start this year and believe 2021 will be another strong year of execution with quality and speed that Zai Lab has been known to deliver; therefore to become a leading global pharmaceutical company by executing our growth strategy. Since Zai Lab was founded in 2014, we have quickly expanded to create a portfolio of 21 innovative products across more than 30 indications. We have now commercialized the first two of these products in China with four indications. In March 2021, we gained approval for QINLOCK, our third oncology product approved within the last 15 months in China. In addition, we recently received encouraging news on several of our key assets from our customers, BLA filing for Efgartigimod in gMG was accepted by the FDA with a PDUFA date of December 17, 2021. The Phase III pivotal LUNAR trial of tumor-treating fields in non-small cell lung cancers was recommended to continue with reduced sample size based on an accelerated interim analysis. Bemarituzumab was granted breakthrough therapy designation by the FDA as first-line treatment for gastric cancer patients who overexpress FGFR2b. We now have a total of 17 products in clinical development, of which 11 are in late-stage development and five have already been approved in the U.S. In short, we have a broad innovative portfolio with a visible pathway to achieve significant sales within just a few years. I also want to highlight that along with our growing platform of utilizing products, we have seven early-stage programs with worldwide rights, including three in global clinical trials. In the first quarter, Zai Lab continues to execute well in all aspects of our business. We entered into several strategic collaborations to further strengthen our gastric and lung cancer disease strongholds; significantly bolstered our autoimmune franchise with an exclusive agreement with argenx for Efgartigimod, a true pipeline-in-a-product; advanced numerous clinical programs towards key data readouts; gained regulatory approval for QINLOCK, our third commercial product in what we expect to become a leading gastric cancer franchise. We generated strong revenue growth with ZEJULA, which was added to NRDL in December of last year. The implementation started in March 2021. Although we are just getting started, we expect to see continued strong volume growth of ZEJULA and remain confident in our abilities to be the market share leader in China for ovarian cancer. With the closing of our recent global public offering with gross proceeds of nearly $860 million, we significantly strengthened our capital position. This new capital will allow us to expand our pipeline through additional strategic partnerships, accelerate the clinical development of our product portfolios, scale R&D and commercialization efforts to drive strong revenue growth and enhance our global pipeline. We remain on target to advance all aspects of our platform throughout 2021. We continue to expect an NMPA approval of NUZYRA for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. We plan to file margetuximab for HER2+ breast cancer, tumor-treating fields for mesothelioma, and ZEJULA for late-line ovarian cancer in China. We're actively engaging with NMPA on a regulatory filing strategy for Efgartigimod in gMG. And we anticipate numerous data readouts, including for tumor-treating fields in liver cancer and ovarian cancer, for QINLOCK in second-line GIST, for margetuximab in gastric cancer, for CLN-081 in non-small cell lung cancer, and for TPX-0022 in non-small cell lung cancer and gastric cancer. In our mission to address serious unmet medical needs for patients in China and around the world, we continue to execute on our aggressive growth strategy to create substantial value. As demonstrated by our progress in the first quarter, we remain focused as ever on achieving our mission, and our future has never been brighter. With that, I'll now ask Tao to discuss our performance and prospects in more detail. Tao?

Thank you, Samantha. I will comment on the performance of our ongoing launches and discuss recent product highlights. First, I'd like to touch on ZEJULA. As a reminder, ZEJULA is approved in China for first- and second-line ovarian cancer and is the only PARP inhibitor approved for all-comers in first-line. In comparison, Lynparza has a label restricting its use to patients with gBRCA mutation, which comprised only about 15% of overall patients in this study. No other PARP inhibitors have been approved for either first- or second-line. The results of the PRIMA study conducted by GSK globally and of the NORA study sponsored by Zai in China demonstrated that an individualized starting dose regimen of ZEJULA preserved efficacy while improving the product's side effect profile. This further differentiates ZEJULA from other PARP inhibitors. This quarter, we achieved an important milestone. Our team was successful in gaining inclusion on the National Reimbursement Drug List for second-line ovarian cancer within the same year of our launch. This further underscores ZEJULA's significant clinical value for a broad range of ovarian cancer patients. The rapid NRDL inclusion provides patients with much greater access, and we're already starting to see strong volume growth. In addition, our team has also been successful in gaining coverage for commercial health insurance, with coverage currently being provided by 67 commercial health insurance plans and 52 supplemental insurance plans. We're very pleased with our launch performance so far. And over time, we believe that ZEJULA will become the leading PARP inhibitor in China. Moving to Optune. As you recall, we launched Optune in China in the second half of 2020. The product is the first novel treatment in GBM approved by the NMPA in the last 15 years. It was highly anticipated by the medical community, and it was already recommended by the national glioma guideline prior to launch. With our team's efforts, Optune became the first innovative medical device supported by commercial health insurance in China, and is also covered in 13 supplemental insurance plans. We deployed an innovative strategy to support patient access and rapid uptake, including establishing 28 direct-to-patient centers in China. Importantly, we're working with our partner, Novocure, to potentially expand the indications of tumor-treating fields in areas of large unmet medical need. Additional late-stage studies are underway in tumor types potentially affecting over 1.5 million new patients a year in China, including in non-small cell lung cancer, where there have been significant developments. Last month, our partner, Novocure, announced an update regarding the global Phase III pivotal LUNAR trial. After the review by an independent data monitoring committee, Novocure was informed that the prespecified interim analysis for the LUNAR trial had been accelerated given the length of accrual and the number of events observed. The DMC further concluded that it is likely unnecessary and possibly unethical for patients randomized to the control arm to continue accrual to 534 patients with 18 months follow-up. The DMC recommended a reduced sample size of approximately 276 patients with a 12 months follow-up, which could potentially accelerate the overall timeline of the trial by more than a year. Novocure has filed an IDE supplement with the FDA and is awaiting the agency's response. We're encouraged by this important update in lung cancer, an area of huge unmet medical need in China. And look forward to additional clinical data readouts for Novocure in pancreatic, liver, and ovarian cancers, in brain metastasis and in glioblastoma with high-intensity arrays. We also have a China-only Phase II pilot trial in gastric cancer that is expected to complete enrollment this year. And we continue to be on target to file tumor-treating fields in mesothelioma later this year. Now, I'd like to discuss the recent regulatory approval for QINLOCK. We filed QINLOCK for approval in China last July. It was accepted under priority review, and the NDA was approved in March, one full quarter ahead of the original schedule. We expect to launch the product in fourth-line GIST in the second quarter. QINLOCK is the first approved tyrosine kinase inhibitor designed specifically for GIST patients regardless of mutational status. The INVICTUS trial demonstrated a significant benefit versus placebo in progression-free survival and overall survival, and served as the basis of the QINLOCK approval in both the U.S. and China. Top-line data for the Phase III global pivotal INTRIGUE trial in second-line GIST are expected in the second half of 2021, and could potentially support label expansion in this important indication. We have many other products we'd like to discuss with you, but in the interest of time, I will highlight one, bemarituzumab. This compound is a first-in-class antibody that is being developed in gastric and gastroesophageal junction cancer as a targeted therapy for tumors that overexpress FGFR2b. In data presented at ASCO GI in January, bemarituzumab, in combination with modified FOLFOX, demonstrated statistically significant improvement versus placebo versus modified FOLFOX in all three efficacy endpoints of the FIGHT trial, including progression-free survival and overall survival. Bemarituzumab could address a significant unmet need in China. There are 680,000 new cases of gastric cancer every year, approximately 87% to 88% of which are HER2 negative, and about 30% of these are potential patients for bemarituzumab. The compound was a key driver in Amgen's $1.9 billion acquisition of Five Prime in April when bemarituzumab also received breakthrough designation from the FDA. Amgen is actively planning for a pivotal Phase II study and is considering expanding the compound into additional indications such as squamous cell non-small cell lung cancer. We will work closely with our new partners to maximize the full potential for this exciting product. I would like to say a few words about our business development execution last quarter and beyond. We entered into three highlighted strategic collaborations recently with argenx, Turning Point, and Cullinan Oncology in Greater China. Efgartigimod became the anchor asset for our autoimmune franchise with true pipeline-in-a-product potential. Since we entered into the partnership, Efgartigimod's BLA for gMG was accepted with a PDUFA date of December 17, 2021. Phase III trials are ongoing in CIDP, pemphigus, and ITP, and Zai Lab plans to enroll Chinese patients in these trials. Argenx also plans to identify and begin clinical testing in two additional indications this year with more being planned for future years. CLN-081 and TPX-0022 significantly bolstered our lung cancer and gastric cancer franchises, two areas where we have built world-class portfolios. These fields are excellent examples of how we use business development as a key strategy to quickly expand our business vertically and horizontally, and create a sustainable platform for Zai Lab. Going forward, with our strong track record of execution and the new capital we raised through recent equity offerings, we will continue to leverage our target choice status to strengthen our pipeline through business development efforts. Our business development pipeline remains very strong. Looking ahead into the remainder of 2021; Zai Lab, alongside our development and commercial partners, is once again positioned to achieve key milestones, which are summarized in our press release. We plan to expand the indications of commercial products, achieve approval for new products, submit for new regulatory approvals, provide key clinical data readouts from both late- and early-stage programs, initiate numerous pivotal studies across our pipeline, advance internally developed assets with global rights, and aggressively pursue new business development opportunities. It goes without saying, we're committed to continuing Zai's track record of efficient and effective execution. Now, I would like to turn the floor over to my colleague, Billy Cho, Chief Financial Officer, to discuss our recent financing and our first quarter 2021 financial results.

Thank you, Tao. I will give a brief summary of our recent financing and review of our financial results for the first quarter of 2021. Last month, we closed on a global offering of both American depository shares and ordinary shares with gross proceeds to Zai Lab of approximately $857.5 million. This offering was the first-ever dual-tranche offering in both NASDAQ and the Hong Kong Stock Exchange. As mentioned before, this new strategic capital will allow us to expand our pipeline through additional collaboration agreements, accelerate the clinical development of our product portfolio and scale the R&D and commercial organizations to drive strong revenue growth and enhance our global pipeline for years to come. Moving to our financial results for the three months ended March 31, 2021. Net product revenues were $20.1 million compared to $8.2 million for the same period in 2020. Revenues for the period were comprised of $12.6 million for ZEJULA compared to $6.3 million for the same period in 2020; and $7.1 million for Optune compared to $1.9 million for the same period in 2020. Research and development expenses were $203.9 million for the three months ended March 31, 2021, compared to $33.7 million for the same period in 2020. The increase in R&D expenses was primarily attributable to the $62.3 million upfront payment in Zai Lab equity, which was determined at the fair value of the shares on the closing date given certain restrictions, and the $75 million development cost-sharing payment to argenx, as well as the $25 million upfront to Turning Point. There were also additional expenses related to ongoing and newly initiated late-stage clinical trials and payroll and payroll-related expenses from increased R&D headcount. Selling, general, and administrative expenses were $35.8 million for the three months ended March 31, 2021, compared to $18.7 million for the same period in 2020. The increase was primarily due to payroll and payroll-related expenses from increased commercial headcount and related costs as Zai Lab continued to expand its commercial operations in China. For the three months ended March 31, 2021, Zai Lab reported a net loss of $232.9 million, or a loss per share attributable to total stockholders of $2.64 compared to a net loss of $48 million or a loss per share attributable to common stockholders of $0.66 for the same period in 2020. As previously highlighted, the increase in net loss was primarily attributable to the new collaboration agreements with argenx and Turning Point recorded in R&D expenses. As of March 31, 2021, cash and cash equivalents, short-term investments, and restricted cash totaled $1.014 billion compared to $1.188 billion as of December 31, 2020. In addition, in April 2021, Zai Lab announced the closing of a global follow-on offering. The expected total proceeds to Zai Lab, including both the American depository shares offering and the ordinary shares offering, net of underwriting fees and other operating expenses, are approximately $818.1 million. We would now like to turn the call back over to the operator to open up the line for questions.

Our first question comes from Yigal Nochomovitz from Citigroup.

Tao, you mentioned that the business development pipeline remains very strong. So what should we expect in terms of the pace of new business development initiatives over the near-term? And is the plan to continue to expand into these areas where you already have exposure, such as oncology, autoimmune, and infectious disease? Or would you consider branching out perhaps into new areas such as rare disease and into additional treatment modalities, for example, cell therapy, where you currently don't have exposure?

Thank you, Yigal. Jonathan, do you want to address that question?

Sure. Thanks for the question, Yigal. So I think over the last few years, we have really established a very sustainable platform as a company. And I think really to our development, commercialization, and regulatory team's combined efforts, we've built up scale, we've built up leadership in China and demonstrated our track record. As a result of that, these days, as Tao mentioned, we're getting a lot of inbound interest from potential partners as well as some existing partners across diverse areas and products. For us, always, we aspire to bring in global quality, best-in-class, first-in-class assets. The quality is always the most important. And I think if you looked at our track record over the last couple of years, it speaks for itself. And as we continue to build, our business development strategy is always to support the company's growth. Our ambition is ultimately to become a global biopharmaceutical company. And so your question also asked about therapeutic areas. If you look at, especially in the last 12 months, we've done a number of deals that actually expanded our therapeutic areas. For example, the Regeneron deal as well as the argenx deal allowed us to get into areas such as hematology and autoimmune diseases, which we did not have a strong presence in beforehand. And very quickly through these anchor assets, we're able to build a nice pipeline in those new areas. So going forward, I think we will continue to strengthen existing disease strongholds in oncology, for example, in lung and gastric areas, and we may also explore new therapeutic areas like what we've done with argenx and Regeneron, as well as potential collaborations that would further accelerate our global ambitions. Hopefully, that answers your question, Yigal.

Our next question is from Seamus Fernandez of Guggenheim.

On targeted therapy. Just hoping you could help us understand amongst the U.S. companies, there are some concerns raised about the pace of targeted therapy and patient identification in the market today. I was hoping to just understand better, given your broad targeted therapy portfolio, how this might differ in China? Or if you just think that the market is misinterpreting the pace of uptake relative to the U.S. market and some other developed markets of these targeted therapies that you have partnered relative to COVID? So, I'm just trying to maybe ask if you guys can tease out a little bit more of the strategy and optionality with your broad targeted portfolio. And if you see that having significant advantages in China or if you just think that the concerns raised today by investors around the pace of targeted therapy update and patient identification are more of a COVID-related issue in your view?

We actually have targeted therapies, immunotherapies, and tumor-treating fields. All three offer functional approaches for combination opportunities. Specifically for targeted therapies, we have, for example, in lung cancer and gastric cancer, special targeted therapies addressing different patient populations. I don't think COVID has much impact on our business from last year and this year; you can see that from our revenue and clinical development perspective. Furthermore, China is aligning closer to developed countries' treatment standards and companion diagnostics companies are also growing well. Together with these global diagnostic companies, we don't see much issue with patient segmentation or finding the right patient population. That being said, if you look at our platform, the current three approved products, they all have all-comer status. For example, ZEJULA is the only first-line all-comer monotherapy ovarian cancer patient, in both first-line and second-line. QINLOCK also has all-comer status for later lines, and Optune has no diagnostic requirement. We are in a very good position to provide broader coverage to patient populations, which each one has a much greater patient population than in other countries. Seamus, did I answer your questions?

Yes, that makes sense. As you move forward, the question is whether there are opportunities to use your wider portfolio to enhance patient identification for the targeted therapies. I understand this is something unique to Zai Lab compared to others. I believe you have addressed my question.

Thank you. Yes, again, you brought a very good point because in each strong disease cohort, we have multiple targeted therapies, so when we go to a doctor, we can offer many different treatment options based on the mutation types. Thank you.

Our next question is from the line of Ziyi Chen of Goldman Sachs.

Congratulations on a strong quarter! With the recent public offering, I think Zai Lab now has a very strong cash position of about $1.8 billion. It would be great if management could share more color on how you're going to spend that money? Are you going to accelerate the pace for business development deals? Or will you focus more on in-house discovery team build-up? Or any color on building out the significantly bigger commercial team? I'm trying to understand how you're going to allocate resources and enhance both the in-house pipeline and commercial strength.

That's a very good question, Ziyi. I'll ask Billy to address the questions.

Sure. Ziyi, thanks for the question. So you're right. Right now, if you add in the capital raised during April, we do have a little over $1.8 billion in cash if you combine that with the March close balance. Specifically to the capital raises from last month, it is based on our fundamental strategic need. So to your question, the answer is yes, in terms of the strategic capital being applied to accelerate the timeline to scale the trial further. Breaking down further into specific areas within the functional departments, a good part of it will go to fund new business opportunities in terms of business development, corporate development, and licensing opportunities that were talked about on the call as well as in the earnings release. Additionally, we've identified opportunities to complete clinical trials, advance drug candidates, and overall scale up our R&D platform. The same goes for our commercial efforts. We have a significant schedule, not only ramping up the three innovative products we have right now but we have many more Q4 potential approvals over the next few years, as you know, with over 10 approval launches in the medium term. Thus, we want to allocate some funding to expand our commercialization efforts. Last but not least, we will also enhance our global pipeline. So these are the four broad areas where we see ourselves deploying this capital to create additional shareholder value.

Our next question is from the line of Anupam Rama of JPM.

Congrats on all the progress. Maybe I can ask a quick one on QINLOCK here. I know it's early days and the GIST launch is expected later this month. But just wondering how we should be thinking about that launch curve relative to ZEJULA?

Thank you for your questions. Billy, do you want to address that?

Yes, sure. Anupam, thanks for the question. You're right; it's an exciting time right now. We're going to have our first launch in the gastric cancer franchise with QINLOCK in advanced GIST. We expect to launch this month in May. We believe we have an opportunity here to establish a new standard of care for treating patients with advantages in China. Later this year, we also have top-line data coming out, so we'll see. As you know, Anupam, there are approximately 30,000 newly diagnosed GIST patients in China every year. It's quite significant, as many as in the U.S. and Europe combined. We see a considerable opportunity ahead. Our commercial team in the gastric cancer franchise is already prepared to launch QINLOCK well and we're ready to go. So we're not giving guidance yet, but it's an exciting time.

Next question is from the line of Jonathan Chang of SVB Leerink.

Congrats on the progress! With the recent approvals of anti-PD-1 drugs in frontline gastric cancer, can you talk about how this impacts your gastric cancer strategy with multiple partner programs in this space?

Thank you for the question. Alan, do you want to address that?

Sure. Thank you very much. As you know, gastric cancer is the second largest cancer in China, both in terms of incidence and mortality, and there is significant unmet need. Fortunately, more treatment options are available. Tao mentioned bemarituzumab earlier. In the meantime, FGFR2b expression appears orthogonal; it appears to occur in those patients not necessarily expressing HER2, for example. There is definitely an unmet need and opportunity in this area. Regarding HER2 and the recent accelerated approval for pemetrexed, we still believe, as do our partners, MacroGenics, that there are considerable opportunities, and we will continue to evaluate margetuximab with PD-1 checkpoint blockades. We believe this may create synergistic antitumor activities to enhance tumor-specific T cell immunity. So we still see considerable opportunities in this important area. Did I address your question?

Yes, partially. Maybe I can just sneak in a follow-up then on bemarituzumab. Specifically, how should we be thinking about next regulatory and development steps? What could a potential Phase III study look like in the context of this evolving gastric cancer landscape?

Jonathan, definitely can.

I think it's safe to say we're working with our partners at Amgen in evaluating the recent changes that have occurred in this particular area. We'll be working towards the optimal design of that Phase III study moving forward.

Next question is from the line of Michael Yee of Jefferies.

Congrats on a great quarter of progress. Going back to the follow-up about the recent significant capital raise. I was wondering about your consistent stated goal to become a global pharmaceutical company. But wondering if that specifically means that you would be interested in expanding more into other geographies, Asia, East or West? And thinking about what that means to become a global pharmaceutical company beyond China? And how the capital raise may play a role in that, if at all?

Michael, thank you. It's early morning for you, right, on the West Coast. As we mentioned earlier, we definitely aspire to be a global biopharma company. In the next three to four years, we're planning to launch an additional 10 products without taking into account any new partnerships, indication expansions, or combination statuses. Additionally, I would like to highlight that China is now the second largest global market, and it is expected to continue with double-digit growth. We're doing well in China and globally. We also have a very strong pipeline. In addition to what we discussed, we already have three approved products, one more expected to be approved this year, and we anticipate 10 more over the next three to four years. We believe our commercial position is strong in Greater China and Asia. However, we have a strong pipeline with both late- and early-stage products that carry global rights, including three in global Phase I products. We believe that in the next three to four years, some of them will enter pivotal stages. Moreover, we have a strong business development team that continues to seek strategic collaborations for promising assets that address unmet medical needs. Some of these can have global rights, while others can have China rights based on the stage and patient population. This aligns with our strategy to supplement our internal pipeline. We have also been expanding our R&D footprint and global R&D team, with teams not only in China but also in Boston and San Francisco. We believe that through all these approaches, we are well positioned to realize our ambitions in the near future.

We have Yang Huang of Crédit Suisse for the next question.

My question is on tumor-treating fields commercialization progress in China. It's been almost a year since we launched the product commercially in China. Can you give us more color on commercial progress? For example, do Chinese patients use the device longer or shorter compared to those in developed countries? Also, how does our collaboration with supplemental insurance in China increase the number of new patients using our devices? Any color on commercialization would be helpful.

Sure. I'll let Billy address your question.

Yang, thanks for the question. The sales of Optune in China have been robust. As you saw from our earnings release, the first quarter of 2021 came in at $7.1 million compared to $1.9 million in the same period last year, and the momentum is quite strong as we continue into the second quarter and beyond. We're not providing full-year guidance yet. However, we did double the number of sales teams from about 50 at launch to about 100 now. To your point about payer types, we agree that our strategy has involved leveraging supplemental insurance coverage to facilitate adoption. Over the longer term, the additional payer pools will likely be favorable. We're currently collecting good data about patient experiences, which is trending in the right direction. We expect Optune to set a new benchmark in terms of sales in its first 12 months.

We have David Ng from Macquarie.

If I may, I can focus on ZEJULA and Optune again. For the first quarter, very strong year-over-year sales. Can you tell a little about the quarter-over-quarter trend for ZEJULA? Specifically after March, when the new price and NRDL coverage kicks in, can you share your on-the-ground observations, especially in terms of volume expansion? Is the speed satisfactory? Has the ramp-up continued into April and May? Sorry, a couple of questions on ZEJULA. On Optune, strategically, in the next three to four years, with fewer competitive threats in China, does it make sense not to go after NRDL at the national level? If that's the case, does it afford your team more time to ramp up gradually and potentially achieve even higher peak sales compared to other innovative drugs that have to go intensive in the first two years post-NRDL inclusion?

Yes. David, I think you asked a lot of questions. For the interest of time, I would like Billy to give some answers.

Sure. Thanks, Samantha. Thanks, David, for the question. Let me address your questions. Regarding Optune, we have robust sales, and as for ZEJULA’s competitive landscape, we believe we are becoming an important asset class, addressing not only ovarian cancer patients but beyond that in China. We've positioned ZEJULA as a best-in-class PARP inhibitor, and although we are not providing specific guidance, we can see positive momentum as we move into our second quarter. Our sales team has doubled, which we think is essential for leveraging the NRDL implementation. We expect good momentum and overall, the outlook for ZEJULA is positive.

Regarding ZEJULA’s competitive landscape, we currently hold the only all-comer status approved for ovarian cancer. In contrast, the two competitors you mentioned are limited to BRCA and later lines; they only launched this year. So, we do not view them as immediate competitors. Therefore, we do not see the need to adjust our strategy due to these newcomers.

I am showing no further questions at this time. I will now turn the call back over to Zai Lab's CEO, Samantha Du, for closing remarks.

Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you periodically on our progress throughout the year. Operator, you may now disconnect this call. Thank you all.

Thank you. And this concludes today's conference call. Thank you for participating. You may now disconnect.