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spk04: Stand by. We thank you for your patience. Today's conference is scheduled to begin shortly. Please continue to stand by. We thank you for your patience. Thank you. Thank you. Thank you. Hello, ladies and gentlemen. Thank you for standing by and welcome to Xylep's first quarter 2022 financial results conference call. At this time, all participants are in the listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. 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 Xylep, who will make introductory comments.
spk12: Thank you, operator. Good morning, good evening, and welcome, everyone. Xyleb recently issued a press release providing the details of the company's financial results for the first quarter ended March 31, 2022, as well as product highlights and corporate updates. The press release is available in the investor relations section of the company's corporate website at ir.xylebatory.com. Today's call will be led by Dr. Samantha Duke, Zalash founder, chairperson, and chief executive officer. She'll be joined by Dr. Alan Sandler, president and head of global development oncology, who will discuss advances with our oncology product candidates. Dr. Harold Reinhart, president and head of global development, neuroscience, autoimmune, and infectious diseases, who will speak about progress we have made in those three therapeutic areas. And I will discuss the performance of our market products and conclude with comments on our financial results. Additional executives will also be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, Dylab 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 timing and success of our clinical trials, our sales and revenue forecasts for our products and product candidates, regulatory applications, and commercial launches. These forward-looking statements are not guarantees of future performance. and therefore you should not put unduly lines upon them. These statements are subject to numerous risks and uncertainties. Actual results could differ materially from what we expected due to a variety of factors, including those discussed in our SEC filings. At this time, it is my pleasure to turn the call over to Dr. Aleph Stoller, Chairperson and Chief Executive Officer, Dr. Samantha Du.
spk03: Thank you, Billy. Hello, everyone, and thank you all for joining us today. Our first quarter results reflect Xi's solid foundation and track record of consistent execution and were marked by progress across the entire portfolio. To kick off today's call, I'd like to highlight the progress made on Xi's proprietary pipeline, which consists of 11 internally developed methods with global rights. Building upon last year's proof-of-concept treatment for GL1102, our anti-L17A human body for chronic plaque psoriasis, I recently unveiled preclinical data from four key young hazard programs at the 2022 AACR Annual Meeting. With this asset, just beginning to enter first-in-human and proof-of-concept clinical studies, we're in the exciting early days of demonstrating Tsai's commitment to in-house discovery and translational research. And of course, this proprietary pipeline complements the advancements within our latest partner pipeline which is expected to produce numerous pivotal study readouts through 2022. As you may recall, at the beginning of this year, we established 2022 strategic priorities that aimed to lead the next wave of biopharma innovation. I'm pleased to say we continue to progress toward achieving these priorities, including progress toward filing the NDA for FGT-MOD in China in mid-2022, initiation of a registration study for bimethylamine with first-line gastric cancer in Greater China, and top-line data readout for CAR-ST from a phase III emergency trial by third quarter 2022 We continue the investment in R&D to advance our proprietary pipeline with global rights, including moving CL1102 into full global development. Importantly, our commercial team continues to drive significant growth with our full market products in Greater China. Before turning the call over to Alan to discuss our oncology franchise in more detail, I'd like to make a brief comment on the ever-evolving COVID-19 situation in China. Tsai continues to monitor the potential impact in certain regions in China, while COVID-19 did not have a significant impact on our business in the first quarter. has presented access difficulties which we believe are likely to have a modest impact in the second quarter in China. Even so, we remain very confident in the underlying strength of our business despite the COVID-19 situation in China and the current macro and geopolitical hazards The fundamental drivers of value at TriLab have further strengthened our expanding leadership team, global talent, and our ever-growing pipeline. The steps we have taken to facilitate access to global capital markets and our track record of consistent execution in putting global first-in-banking costs and assets to patients in China and beyond We at Xilab remain committed to pursue our overall goal of improving human health worldwide and to build a leading global biopharmaceutical company. Now I'd like to turn the call over to Dr. Alan Sandler. Alan?
spk07: Thank you, Samantha. Xilab's oncology franchise continued to make progress in the first quarter. And we expect to have a busy and productive remainder of 2022. As Samantha mentioned, most recently, we unveiled initial preclinical data at the AACR annual meeting from key programs within our growing internally discovered oncology pipeline. In an oral presentation, the company presented data on our CCR8 targeted antibody, ZL1218. ZL1218 is a novel antibody that targets the CCR8 receptor selectively expressed on resident Tregs in solid tumors. I highlighted the anti-tumor activity of ZL1218 in an animal model, both as a single agent and in combination with anti-PD1. Additional poster presentations at AACR included Preclinical data from our CD47 targeting antibody, ZL1201, which is being studied in both advanced lymphomas and solid tumors. Our Clawdin 18.2 specific antibody, ZL1211, which has potential applications in gastric and pancreatic cancer. And our highly selective small molecule DNA PK inhibitor, ZL2201, which has potential broad anti-cancer applications. In 2022, we plan to submit up to two INDs from our internal R&D platform with the goal of filing at least one IND per year going forward. Our late-stage development programs in oncology continue to make progress on all fronts in the first quarter. For Repotrectinib, we recently announced efficacy data from the Phase I-II Trident I study revealing comparable results for ROS1-positive non-small cell lung cancer cohorts in China and global clinical trial sites. In TKI-naive patients in China, the confirmed objective response rate was 91% and 79% for global sites. In TKI-pretreated patients in China, The ORR was 36% in those treated with one prior line TKI compared to 36% for global sites. The ORR was 67% in those treated with one prior line TKI and one prior line platinum-based chemotherapy compared to 42% for global sites. and the ORR was 50% in those treated with two prior lines TKI globally compared to 28% for global sites. Notable, all of those numbers represent confirmed responses. It is encouraging to see this comparative efficacy data analysis exploring clinical trial data from sites in China and globally for Reprotrectinib, a potentially best-in-class drug candidate for patients with ROS1-positive TKI advanced non-small cell lung cancer. With over 800,000 newly diagnosed lung cancer patients every year in China, non-small cell lung cancer accounts for approximately 85% of the cases, and ROS1 rearrangements occur in 2% to 3% of those patients with advanced non-small cell lung cancer. The majority of these patients are diagnosed with advanced disease, representing a significant unmet medical need. We will continue to work closely with Turning Point to advance this program to help support non-small cell lung cancer patients in China and around the world. Moving to Zejula, we presented positive results from the phase three prime study of Zejula as maintenance therapy at the Society of Gynecologic Oncology annual meeting in March this year. In the prime study, median progression-free survival was significantly longer for patients treated with the raparib compared to placebo, 24.8 months versus 8.3 months. For G-braca mutated patients, median PFS was not reached versus 10.8 months for the non-G-braca mutated patients. Median PFS was 19.3 months versus 8.3 months. Overall survival data was still immature, although there was a trend favoring norepinephrine at the data cutoff. We believe that the prime study further underscores the status of Zejula as the first and only PARP inhibitor approved globally as monotherapy for all-comer patients in the first-line maintenance treatment settings. Now, touching briefly on our later-stage pipeline, 2022-2021, is poised to be another productive year with important pivotal data readouts, including top-line data from the TT Field's Phase III Pivotal Lunar Clinical Trial and a clinical data update from the Adagraphib Phase II Registration-Enabling Non-Small Cell Lung Cancer Cohort of the CRYSTAL-1 Study. With an abundance of potentially best-in-class and first-in-class products, We're very excited about our oncology pipeline at Xylem. And now, I will turn the floor over to Dr. Harold Reinhardt to discuss progress in our autoimmune and neuroscience therapeutic areas. Harold?
spk00: Thank you, Alan. I'll start with autoimmune diseases and F-Cartigimod, or its marketed name, VivCard. In March 2022, Xipartner Argenics announced positive top-line data from the Phase III ADAPT-SC study, evaluating subcutaneous F-card tigemod for the treatment of generalized myasthenia gravis, or GMG. SubqF-card tigemod achieved the same amount of IgG reduction as the F-card tigemod IV formulation in GMG patients, specifically Sub-QF Gartigimod demonstrated mean total IgG reductions of 66.4% from baseline at day 29, compared to 62.2% with IV F-Gartigimod. Results were consistent across the entire population, irrespective of acetylcholine receptor antibody status. Our partner, Igenix, plans to submit a BLA to the FDA by the end of 2022. Just a few weeks ago, Argenix announced interim results from the ongoing Phase III ADAPT-Plus study, a three-year extension study evaluating long-term safety, tolerability, and efficacy of F-Gar-Tigimod for the treatment of adults with GMG. These data suggest that long-term treatment with repeated cycles of FKTG-MOD provide undiminished benefits with each treatment course. The safety profile was consistent with what was observed in the pivotal program. Moving to CL1102, our topical IL-17 monoclonal antibody fragment. Last quarter, we reported that we were very excited to show skin penetration and early clinical benefit in a proof-of-concept trial in patients with chronic plaque psoriasis. As many of you know, the market opportunity for CL1102 is quite significant. Psoriasis affects approximately 125 million people worldwide, of which 80% to 90% suffer from chronic plaque psoriasis, and 70% to 80% of these patients have mild to moderately severe disease. There is a strong rationale and patient need to develop a topical formulation with IL-17 directive therapy that works directly on the lesion and avoids systemic exposure and side effects. Current topical therapies provide limited efficacy or have safety issues with longer-term use. We are working hard to bring this innovative treatment option to patients in need as quickly as possible. In March 2022, we filed a patent for topical hydrogel, ramped up drug substance product production to support Phase II clinical trial activities and submitted a pre-IND meeting dossier to the FDA. We are on track to start a dose finding phase two trial of CL1102 in the second half of this year. Moving on to the neuroscience area. As you recall, last November, we entered into an agreement with Corona Therapeutics for rights to CAR XT in Greater China. CAR XT, is an oral investigational drug combination consisting of xenomaline, a muscarinic agonist that stimulates the M1, M4 receptors in the central nervous system, and traspium, a muscarinic antagonist that reduces the incidence of peripheral GI side effects. In the phase two emergent one trial, CAR-XT demonstrated clinically meaningful and statistically significant improvements in the positive and negative syndrome score, or PANS total score, and also in the PANS positive and PANS negative sub scores. CARXT was well tolerated, much better than Xanomalin alone. Our partner, Corona, expects to report top line data from the pivotal phase three study, AKA also known as the emergent two trial in third quarter 2022. In addition, Karuna expects to initiate a study in Alzheimer patients with psychosis in mid 2022. As part of a bridging program, the XAI team is getting ready to submit the clinical trial application for pharmacokinetic study in China, designing a clinical trial program in collaboration with Chinese key opinion leaders, and preparing for a meeting with the CDE in mid-2022. Now, switching over to our two antibiotic programs, we will have major regulatory interactions for both of these this year. First, an update on Zolobactam-Dolobactam, our drug for multidrug-resistant Acinetobacter infections. Our partner, Intasis, had a successful PNDA meeting with the FDA this spring, and is on course for US NDA submission in mid-2022. Likewise, XAI will hold meetings with the CDE to discuss CMC filing requirements as there are subtle differences between the US and China, and to respond to CDE queries from the last meeting. Our current plan is for a China submission in the fourth quarter of 2022. We will request breakthrough designation and ask for expedited review given the high unmet medical need for this important new drug in China. Omadacycline, Nuzaira, was just launched in China with our China partner, Hanway. On the commercial front, We hope to see the same strong healthcare provider and patient uptake in China that has been seen in the United States. Zai will meet with CDE later this year to discuss post-approval studies, which we are currently designing with expert input to meet both regulatory expectations and to support marketing efforts. And now, Billy will speak about progress with our commercial products and financial results.
spk12: Billy? As Samantha mentioned, we have taken multiple actions to facilitate access to global capital markets, and we expect Xilab to continue to have strong liquidity in the future. In April, we announced the engagement of KPMG LLP, a U.S. auditor, as our independent registered public accounting firm. KPMG will be engaged to audit the annual consolidated financial statement of Xilab filed with the US SEC and our internal controls over financial reporting for the fiscal year ending December 31, 2022. The engagement of KPMG is a natural outlet of our continued evolution into a global biopharmaceutical company. Consistent with our globalization strategy, we view our global shareholder base as key to our future success and to achieving our vision of improving human health worldwide. KPMG's engagement facilitates continued global liquidity for our shareholders through our NASDAQ and Hong Kong Stock Exchange listings. The transition to a U.S. auditor like KPMG also fits well with our existing and growing presence in the United States. In addition, we have announced our plan to pursue voluntary conversion to dual primary listing on the main board of the Hong Kong Stock Exchange recently. Becoming a dual primary listed company will enable us to be eligible for Stock Connect, which is a key channel by which investors in mainland China can invest in stocks traded on the Hong Kong Stock Exchange. We want to provide all investors with robust liquidity for our ADSs traded on NASDAQ, as well as ordinary shares traded on the Hong Kong Stock Exchange. This follows from our share split of our ordinary shares in issue, which became effective March 30, 2022. Moving to our commercial performance, our strong commercial execution continues to drive robust revenue growth in our four marketed products, Zijula, Optune, Kinloch, and Luzara. Zijula continues to perform well, building on the news from year end 2021, when the first line of ovarian cancer indication was included in the NRDL. With this favorable reimbursement decision and Zijula's unique label for ovarian cancer patients regardless of biomarker status, we are seeing a promising trend of gaining market share of Zijula in the first three months of this year. And we continue to expect it to achieve a leadership position among therapies available to treat ovarian cancer no later than next year. In addition, as of March 31, 2022, Jijula was listed in over 1,500 hospitals in China, providing a strong foundation for post-NRDO performance. Similarly, we continue to achieve solid growth in Optune. In the first quarter, Optune continued to be one of the top three treatments reimbursed. As for Likimlox, we are committed to establishing it as a standard treatment for fourth-line GIST. which has over 7,000 new patients every year in China and growing. As of March 31, 2022, Optune and Kinloch are covered by 37 and 58 municipal or provincial supplemental insurance plans in China, respectively. As we noted last year, Nezira was successfully launched in China in December. It is a novel antibiotic with both oral and intravenous formulation. It has treatment of community-acquired bacterial pneumonia, or CAP, and acute bacterial skin and skin structure infection, or APSE. Nuzara was approved as a Category 1 innovative drug and is locally manufactured in China. We believe Nuzara is a potential best-in-class tetracycline with demonstrated efficacy comparable to moxifloxacin in CAP and to linazolid in APSE. With significant unmet needs for broad-spectrum antibiotics addressing MDR infections with a favorable safety profile, We expect to seek NRDL inclusion for both indications this year to benefit many more patients in need. Now I will discuss first quarter financial results. Total revenues for the first quarter of 2022 were $46.7 million, up from $20.1 million for the same period in 2021. As mentioned, we are very pleased with the successful launches and sales trajectory of our market products. With many more product launches to come, our commercial platform over time is expected to generate strong continued growth and considerable operating leverage. Zedula sales for first quarter of 2022 were $29.6 million. Over the same period in 2021, Zedula sales were $12.6 million. Optum sales for first quarter were $12.8 million. Over the same period in 2021, Optum sales were $7.1 million. Kinloch sales for first quarter were $3 million. Over the same period in 2021, Kinlog sales were $0.4 million. Desire sales for the first quarter were $0.7 million. Research and development expenses were $53.9 million for the first quarter of 2022, compared to $203.9 million for the same period in 2021. The decrease in R&D expenses was primarily due to no upfront payment for new licensing agreements, partially offset by increased expenses related to ongoing and newly initiated late-stage clinical trials, and higher payroll and payroll-related expenses from increased R&D headcount. Excluding upfront payments for new licensing agreements, the core R&D expenses were $53.9 million for the first quarter of 2022 compared to $41.6 million for the same period in 2021. Selling, general, and administrative expenses were $57 million for the first quarter of 2022 compared to $35.8 million for the same period in 2021. The increase was primarily due to payroll and payroll-related expenses from increased commercial and general administrative headcount, as Xilab continues to expand and invest in its commercial operations in China in anticipation of substantial top-line growth over the next few years. Xilab reported a net loss of $82.4 million for the first quarter of 2022, or a loss per share attributable to common stockholders of 9 cents. compared to a net loss of $232.9 million, where a loss per share attributable to common stockholders of $0.26 for the same period in 2021. As of March 31, 2022, cash and cash equivalent, short-term investment, and restricted cash totaled $1.31 billion, compared to $1.41 billion as of December 31, 2021. We would now like to turn the call back over to the operator to open up the line for questions. Operator?
spk04: Thank you. We would now like to open the line for questions. If you have a question, please press star 1 at this time. If you wish to cancel your request, please press the pound or hash key. Once again, this is star 1 for questions. Our first question comes from the line of Michael E. from Jefferies. Please ask your question.
spk01: Thank you. Good morning. Appreciate the update. We had two questions. One was a big picture question and one was a pipeline question. From a big picture perspective, obviously investors are watching afar but a bit concerned about the various challenges in China. Maybe you could just talk a little bit about some of the commercial dynamics and whether there's any impact due to lockdowns and access to hospitals and particularly with respect to enrolling clinical trials in A lot of different companies are saying different things, so if you could give us a snapshot of what's going on there, that would be helpful. And the pipeline question is, you affirmed in your press release that you are planning to submit F-Card Digimod to China FDA in the middle of this year. Did you actually meet with the FDA and confirm that that's okay, or are you still in discussions? If you could shed some light there, that would be great. Thank you.
spk12: Hey, Mike. Thanks for your questions. I'll take the first one and give the second one to either Samantha or Harold. So in terms of the COVID situation, we've been operating under a COVID environment for well over two years now and have developed protocols and procedures which have now been in place to minimize impact throughout this time. Now, as you maybe heard from prepared remarks, remarks, there are some challenges in the second quarter, particularly in Shanghai. So we're continuing to monitor very closely, but I would like to report that as of the most recent statistic, the number of new cases are less than 5%. It may be even less than 4% of the peak. And yesterday, there were zero cases found in the community. So most importantly, overall, at this particular point in time, we do not feel a need to make any changes to our previously communicated execution goals for this year, including all of our clinical development and regulatory milestones. And in terms of the global programs and strategies that we have, there's no impact there. And all of our programs are on track, including initiating our global phase two trial of the L17 program called GL1102 in the second half of this year.
spk06: Great to hear on that. And FGAR, to Jamon.
spk00: Yes. Yeah, hi. Thank you so much for the question on FGAR and this regulatory pathway forward. Yes, we have indeed plans to meet with, not FDA, but CDE, the middle of this year. And we have already submitted a dossier to them in follow-up to a communication which we had with them last year. You may recall, and we mentioned it in our press releases, that we had a very good meeting with them about what would be the ingredients they expect in our dossier. In the meantime, since that meeting last year, a lot of things have happened, including the results of our PK studies in China came through, and more importantly, even the Japan approval for F-Gytegumon, which is a broad label for this drug. So we are now ready and awaiting a response from the CDE. on our proposed plans going forward. So when that meeting will be exactly, we don't know, but it will hopefully happen in the middle of this year, and that will dictate what we will do subsequently.
spk06: Got it. Thank you very much.
spk04: Thank you. Our next question comes from Ego from CT Group. Please ask your question.
spk13: Hey, Samantha and Billy and team, thank you for taking the questions. I have one for you, Billy. Just regarding the news last month that you announced KPMG will be engaged as ZEI's independent registered accounting firm, just wondering, are there any other operational or technical steps that you need to gain compliance with HFCAA at this point? Or is the inspection by the PCAOB the only step? And if inspection is the only step left, Could you just clarify what sign KPMG need to demonstrate on this inspection to satisfy the regulators? Thank you.
spk12: Yeah, hey, Igor. Thanks for your question. You're right. On April 21st, we did make a press release and problem 8K where our audit committee or our board appointed KPMG US as our auditor for the purposes of filing the financial statements with the SEC and Hong Kong for that matter. And as many of you know, a county from the U.S., like you can be U.S., is subject to inspection by the PCOD. And therefore, consistent with what we've been stating and also filing in our Qs last year and our most recent K, we don't expect any interruption to our NASDAQ listing. And we expect and with very high confidence that we will comply with HFCAA, and we do fully expect to be off the list in the next 10K cycle. Okay, gotcha.
spk13: And then maybe a question for Samantha or Alan, shifting to the pipeline, regarding the in-house topical IL-17. I think you indicated that ZEI is meeting with FDA soon to design a comprehensive Phase II program, which, as you noted in the call, is expected to be a global multicenter study in chronic plaque psoriasis. So first question is, operationally, have you had that engagement yet with FDA? And if so, what were the takeaways? And then secondly, looking further down the road, since 1102 is obviously a wholly-owned program, I'm just curious, what are your thoughts on whether you would launch this product beyond China? Obviously, this is a highly appealing product for the U.S., European, and Japanese markets. And additionally, given the recent addition of Josh Smiley to the team, his experience at Lilly in scaling pharma businesses I think could prove very useful in building an international franchise for 1102. So if you could offer your thoughts there, that would be great. Thank you.
spk00: Yeah, this is, I guess, a question for me. IL-17 and 1102 is indeed now going and getting ready for a phase two study in the US. This is something which we need to still discuss with FDA. So to your question, we did not have this meeting yet, but we have submitted the dossier. So we will hear from them back and adjust accordingly, but we still believe that we can start this study Phase II study, multicenter, as you said, placebo-controlled and all the rest by the end of this year. As far as your question goes about The global reach, maybe I can hand over to others, but I do believe this has indeed attractiveness in many, many regions, and we will discuss this in-house and with our marketing people in great, great detail how to stagger our approach. Over to you, Billy.
spk03: Thank you, Carol.
spk12: Samantha, please.
spk03: Yeah, yes. Thanks, Nicole. And just as you said, as we announced in the release, Josh will be the CEO of Satellite beginning August 1st. And you are correct. Josh has great experience in building our business on a global basis. You have no doubt he will be a key contributing member of our globalization effort. In terms of where this project is going, I think we are very open. We have the capability to do it in-house, but we're also open to potential partners.
spk13: Got it. Thank you. Thank you very much. Thank you, all.
spk04: Thank you. Our next question comes from Anupam Rama from JP Morgan. Please ask your question.
spk02: Hey, guys. Thanks so much for taking the question. Maybe following up on one of the prior questions, can you give us a sense of the strategies that you have in place for your sales team to continue to engage with physicians in the region, given, you know, the COVID-19 restrictions we've kind of talked about on this call in certain regions? Thanks so much.
spk12: Hey, Anupam. Yeah, I'm happy to, you know, give some examples. You know, when we stated earlier, how you know working under this environment and we've developed some protocols and procedures so uh some examples uh there's a range but two that can spit out to you one would be um you know figuring out a way where you know with a digital solution um you can promote engage with the medical community in a compliant way uh so you know we had to actually build that um and uh so that's an example another example would be where a patient with prescription let's say, due to, and there's been flare-ups, right, historically in China over the past two-plus years, and, you know, figuring out ways and having tactical strategies in place to help to build that prescription potentially at another facility and having protocols and systems in place for that. So hopefully that gives you a little bit of a flavor of what we're talking about here.
spk02: Thanks so much for taking our questions.
spk04: Thank you. Our next question comes from Jonathan Chang from SBB Securities. Please ask your question.
spk08: Hi, guys. Thanks for taking my questions. First question, with the recent volatility in the markets, can you discuss how your strategy around business development, especially with smaller and earlier stage companies, has changed, if at all?
spk10: John, do you want to take this one? Yeah, sure. Hi, Jonathan. Thanks for the question. So, you know, we are, as always, focused on continually building a pipeline of world-class assets with a balance of both internal as well as external efforts. In the current environment, you know, we also do see a lot of interesting and promising opportunities, you know, which is very good from BD perspective. You know, if you sort of look at more than half of the U.S. biotech companies today are trading under cash. So we do see potential opportunities to pick up great assets, you know, at good prices. At the same time, you know, we continue to also have very strong interest from Western companies as they think about China, how to leverage China to access the second largest pharmaceutical market, but also to accelerate their global timeline. So, you know, we have continued good source of those type of opportunities as well. As always, I think we'll be very selective when it comes to any BD opportunity. We have a very high bar in green assets. I'll also acknowledge that today our share price is severely dislocated. So any opportunity, you know, we'll have an even higher bar to meet in today's market in the current environment. And we certainly think about BD in light of this context.
spk08: Got it. Thanks for taking that question. And I guess second question for me, can you provide some color on the Zerula sales trend since first line and our tail inclusion?
spk12: Hey, Jonathan. Yeah. So, you know, we're not giving script data, market share data publicly, although we have them internally. And some of the data are available through our QV, etc., But what you will see is a very clear market share gain that actually starts from even, you know, let's say third quarter last year, fourth quarter, you know, and into this year. You saw that the Jula, you know, it was, of course, year over year up substantially and even fourth quarter, the first quarter, you know, in the first quarter where you have the NRDO implementation and a seasonally low quarter, right, seasonally low quarter in China through the holidays, et cetera, you saw that we were able to offset, you know, the 23% price discount with nice revenue. And that's on, that's in a situation where, you know, it's not like you flip on a switch on January 1st and all of a sudden nationwide you have listings and prescriptions. You actually have to go out and now in a very robust fashion get on the hospital list, then try prescription and re-prescription. So it's a credit to our commercial team, you know, that, you know, that we had the first quarter performance and we're quite pleased with that. And a lot of that, of course, is coming from first-line on the NRDL. And you should expect to see a similar trend second, third, fourth quarter and beyond. And you should also expect to see market share gains along the way as well.
spk08: Got it. Thanks for taking my questions.
spk04: Thank you. Next question comes from from Goldman Sachs. Please ask your question.
spk11: Thank you for taking my questions. Just one simple question on the cash burn. So first quarter cash burn has been significantly below, you know, previous quarters. And so that's a pretty deal-like quarter. There was no licensing fees in the first quarter. what would that guide us to think about the overall budgeting for the rest of the year and particularly facing the tough funding environment? What are the possible ways, strategies to extend the cash runway? And if, you know, you have to manage your budget, how will that affect your BD commitment? Thank you.
spk12: Yeah, I see. I'm happy to take this one. So I guess, you know, first of all, you know, we have a very, and we've been saying this all along, but we actually have a very, you know, kind of productive and efficient, you know, platform by design and by strategy. You know, I think that historically, you know, and more recently we've been giving guidance around, okay, BD cost versus core R&D. But it's not really BD versus R&D. It's really integrated. And, you know, by being able to, you know, build a portfolio with much higher probability of success, and a development and regulation strategy, regulatory strategy that plugs into a global trial, it really is by design in terms of efficiency. So you're seeing some of that. But yeah, I mean, so overall, in terms of cash sort of firm runway type of commentary, even with BD deals, we're going to have runway to the end of 2024. and there even could be a future where BD activity results in capital inflow. So today, you know, we have 1.3 billion in cash. Our cash burned for first quarter was 97 million. That's on a net loss basis, on a P&L basis, but cash burned was 97 million, and that's down from 160 in Q4 of last year, and also down from 171 million in, you know, year over year. So, you know, I think You know, we can't, you know, it's difficult to give guidance, you know, on upfront payment for the year, but it won't be at 2021 levels. And, you know, as we've, you know, spoke before with you, you should look at the historical three-year range. And over 19, 20, and 21, you know, those numbers were $59 million, $108 million, $384 million, respectively. And I already told you that it's not going to be 384.
spk11: Got it. Thank you, Billy.
spk04: Thank you. Our next question comes from Yang Huang from Credit Suisse. Please ask your question.
spk09: Thanks for giving me opportunity to ask. I have two quick ones. First is kind of quick follow-up on COVID. So given lockdown in some of Chinese cities in first quarter and the second quarter, I wonder, do we see any drug-stalking and dynamic change in the first quarter and also the second quarter this year compared to last year? That's my first question.
spk12: Hey, Yong. Yeah, in terms of inventory to channel stocking strategy, there's no material change. There could be some kind of nuanced incremental activity given what's going on, but nothing material. So our strategy there is quite comparable, quite consistent.
spk09: Okay, I see. And my second question is on our SG&A expense. So compared to the same period last year, we still see significant increase on SG&A, which is due to our headcount increase. So I'm wondering during this kind of difficult period, what is our overall plan for headcount increase for the whole year, and what's the rationale behind it?
spk12: Yeah, so SG&A, you're right, Yang, in terms of year-over-year, so first quarter compared to first quarter last year to first quarter this year, our SG&A was up 59%. But it was actually down Q4 to Q1. So what that means is that at Q1 of last year, we were still in build mode, you know, namely in our commercial team as well. But this year, we don't expect that, you know, we don't need to expand on our commercial presence. You know, we already have 950 employees And we're going to be able to ramp up revenue while not adding a material number, right? It could be just incremental at most. So that's operating leverage kicking in. And so SG&A will be up overall year over year, but it will not be close to the level from first quarter of last year to first quarter this year for the reasons I stated.
spk09: Okay, got it. Thanks a lot.
spk04: Great. Thank you. We have reached the end of the question and answer session. I will turn the call back to Xylef's CEO, Samantha Du, for closing remarks.
spk03: Thank you, Arthur. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you again after the second quarter. Operators, you may now disconnect this call.
spk04: Thank you. That does conclude our conference for today. Thank you for participating.
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