Earnings Transcript for EQRXW - Q1 Fiscal Year 2022

Operator: Good day, and welcome to the EQRx First Quarter 2022 Financial Results Conference Call. At this time, all participants are on a listen-only mode. After the speakers' presentation there will be a question and answer session. [Operator Instructions] As a reminder, this call may be recorded. I would now like to turn the call over to Neil Swami, Head of Investor Relations. You may begin.

Neil Swami: Thank you, Operator, and good morning everyone. Earlier today, we issued a press release providing an overview of our first quarter 2022 financial results and our recent corporate progress. A copy of this release and presentation to accompany this call are available on the investor relations section of our website at investors.eqrx.com. Joining me on the call this morning are Melanie Nallicheri, President and Chief Executive Officer; Jami Rubin, Chief Financial Officer, and Dr. Eric Hedrick, Chief Physician Executive. Before we get started, I would like to remind everyone that, some of the statements that we make on this call and information presented in the slide deck include forward-looking statements as outlined on Slide 2. Actual events and results could differ materially from those expressed or implied by any forward-looking statements, as a result of various risks, uncertainties, and other factors, including those set forth in our most recent filings with the SEC and other future filings that we may make with the SEC. You are cautioned not to place any undue reliance on these forward-looking statements and EQRx disclaimed any obligation to update such statements. I will now turn the call over to Melanie.

Melanie Nallicheri: Thank you, Neil. Good morning, everyone. And thank you for joining us for our first quarterly investor conference call. Turning to Slide 3, our mission is to improve health for all with great, innovative, affordable medicines. We're doing this by creating a network of payers and health systems that are true partners to us, our Global Buyers Club, they help drive the pull through of our therapies for patients. Our platform aims to align incentives across the healthcare ecosystem and create true population level access by offering radically lower prices. We are enabling our Global Buyers Club members to pull through and the more they save, the more their patients save generating greater volumes for EQRx. And we are doing this at scale. Our aim is to create a large catalog of high quality branded medicines that are equally good or better than what is currently available to patients. Our focus is on addressing high cost diseases of today and tomorrow, starting with cancer and immune inflammatory disorders. Simply put, we are providing a market based solution to address the rising costs of prescription medicines around the world. We believe this platform will enable EQRx to be a profitable and sustainable company. Moving to our performance, in the first quarter, our team continued its relentless focus on execution. We made great progress in advancing both our future catalog of medicines and the Global Buyers Club. We would like you to come away with three key takeaways from today, as outlined on Slide 4. First, our lead oncology programs, aumolertinib and sugemalimab are differentiated programs with promising clinical evidence. Constructive conversations are ongoing with the FDA to create greater clarity on the regulatory path forward in the US. We will share additional details when appropriate. Outside the US, we remain on track while first regulatory submissions for these programs during the second half of this year, our mission is global and there are important and sizable market opportunities outside the US. We look forward to next month's ASCO Annual meeting, where new data will be presented for our aumolertinib and sugemalimab, including an oral presentation featuring sugemalimab in relapsed or refractory ENKTL array type of lymphoma with no FDA approved therapies, as well as the first presentation of sugemalimab interim overall survival data from a pre-specified analysis in previously untreated stage four non small cell lung cancer. Second, turning to our Global Buyers Club, we converted our first memorandum of understanding to a pre-commercialization agreement and we will continue to work to progress other MOUs to this next phase. We have multiple discussions, ongoing and payer and health system interest in our programs remain strong. Third, we are very fortunate to be in an exceptionally strong financial position. We ended Q1 with 1.6 billion in cash and cash equivalent, are on track to achieve 400 million or less of operating expenses in 2022, and continue to expect to have cash runway into 2025. With that introduction, I will now turn the call over to Eric who will discuss aumolertinib and sugemalimab in greater detail. Eric?

Eric Hedrick: Thanks Melanie. I'll begin with aumolertnib on Slide 5. As many of you are aware aumolertinib is a third generation EGFR inhibitor intended for the treatment of patients with advanced EGFR mutated non-small cell lung cancer. In the Phase 3 AENEAS trial aumolertnib was shown to provided clinically and statistically significant improvement in progression-free survival, the endpoint of clinical and regulatory interest in the initial treatment setting of metastatic EGFR mutated lung cancer. Consistent with aumolertnib’s metabolic profile, the study also suggested that aumolertnib might provide an advantage over currently available EGFR inhibitors with respect to toxicity, such as rash and diarrhea. We're looking forward to a presentation at the upcoming ASCO annual meeting of data from the AENEAS trial describing the benefit of aumolertnib in patient’s brain metastasis. Given the frequency of brain metastases in this type of lung cancer and the significant morbidity and profound quality of life impact associated with brain metastases, robust benefit in this setting is paramount. With respect to additional evidence generation, in the second half of this year, we are planning to initiate a randomized multi-regional US-wide clinical trial, which will evaluate the clinical comparability between aumolertnib and osimertinib with a third study on assessing the potential clinical benefit of the addition of chemotherapy to aumolertnib in the first line metastatic treatment setting. This study designed to enroll a diverse and inclusive patient population will address the applicability of the results of the AENEAS trial to current U.S. medical practice will also assess potential tolerability differences between these two third generation EGFR inhibitors. This study will also evaluate important questions regarding the optimal use of EGFR inhibitors in this treatment of this disease. In addition, a clinical trial in the adjuvant treatment setting of each EGFR-mutated lung cancer is ongoing in China, and we are planning to expand this study to include multi-regional enrollment. Given the magnitude of benefit established with other EGFR inhibitors in this setting, establishing the efficacy and safety of aumolertnib and assessing the impact of potential safety differences on tolerability, a critical consideration in patients with earlier stages of disease, will be important in understanding the role of aumolertnib in the breadth of management of EGFR-mutated lung cancer. We are continuing to engage with various regulatory authorities across the world around potential filings for approval. In the UK, for example, we've received Innovation Passport designation for aumolertnib from the MHRA, which provides an opportunity for coordinated review amongst agencies in an expedited review process. Based on the nature of the discussions with regulators outside the U.S. we remain confident that we are on track for our first submissions in the second half of this year. We also continue what we consider to be a constructive dialogue with the U.S. FDA regarding conditions under which aumolertinib may be filed for approval. Understanding that there are concerns about the applicability of single country ex-U.S. data to current us practice, we are committed to addressing these concerns and are working with the FDA to define a path to U.S. approval for aumolertinib. I'll now turn to Slide 6 to discuss sugemalimab, which is our anti PD-L1 monoclonal antibody for the treatment of non-small cell lung cancer and other diseases. As a reminder, sugemalimab has completed two large Phase III studies, one in Stage IV non-small cell lung cancer and the other in Stage III non-small cell lung cancer. Note that sugemalimab has also been evaluated in a now completed pivotal study in relapse or refractory extra nodal NKT cell lymphoma, a rare type of lymphoma with no approved therapies. As Melanie mentioned, we are looking forward to two key presentations of new sugemalimab data at ASCO. This includes the first presentation of interim overall survival data of the pivotal Phase III GEMSTONE-302 study of sugemalimab in combination with chemotherapy in previously untreated stage four lung cancer. Recall that in January, we announced that sugemalimab in combination with chemotherapy that demonstrated a statistically and clinically significant overall survival improvement, in patients with Stage IV disease, including patients with both squamous and non-squamous histology. Of note, these overall survival findings were based on a pre-specified alpha controlled analysis, which is an important regulatory consideration. Also at ASCO, there will be an oral presentation featuring the primary analysis from the Phase II GEMSTONE-201 study or sugemalimab in relapsed or refractory extra nodal NKT cell lymphoma. This trial met its primary endpoint of objective response rate and response duration in patients with relapse to refractory ENKTL. These two ASCO presentations will add to a growing body of clinical evidence for sugemalimab in a number of different cancer treatment settings. We also anticipate additional Phase III sugemalimab data in the not too distant future. This includes overall survival results from the GEMSTONE-301 study evaluating sugemalimab in the maintenance setting, following chemo-radiotherapy for Stage III non-small cell lung cancer. Again, these results will be from a pre-specified analysis and are expected in 2023. Importantly, the study evaluates sugemalimab following either sequential or concurrent chemo radiotherapy. The inclusion of patients who had received sequential chemo radiotherapy is of particular importance as the population enrolled in this study, is reflective of current U.S. practice, in which approximately 40% of Stage III patients in the U.S. received chemo radiotherapy in the sequential fashion. To-date, other immune checkpoint inhibitors have been studied and approved only as maintenance therapy, following concurrent chemo radiotherapy. We are also supporting an expanded access program in ENKTL that is open to patients in the U.S. which reinforces our commitment to addressing unmet medical needs. A regulatory submission for relapsed or refractory ENKTL is expected in the U.S. in 2023. And as a reminder, sugemalimab was granted breakthrough therapy designation by the FDA for ENKTL. To further dwell on sugemalimab's body of evidence, we are planning to initiate a US-led randomized clinical trial that is intended to support a future U.S. filing in consultation with the FDA, which will provide comparative data for sugemalimab with other approved immune checkpoint inhibitors and into diverse and inclusive population of non-small cell lung cancer patients. Regarding regulatory processes for sugemalimab, we are continuing to engage with regulatory authorities across the globe around potential filings and approval in non-small cell lung cancer. As I mentioned, these are important robust market opportunities, we remain on track for our first submissions for sugemalimab outside the U.S. in the second half of this year. We also continue what we consider to be a constructive dialogue with the U.S. FDA regarding conditions under which sugemalimab may be filed for approval in the U.S. Understanding that there are concerns about the applicability of single country ex-U.S. data to current US practice, we're committed to addressing these concerns and working with the FDA to find a path forward for aumolertinib. And with that, I will turn the call back over to Melanie. Melanie?

Melanie Nallicheri: Thanks, Eric. Moving to Slide 7, as you can see, we are building a robust pipeline, which includes multiple clinical stage programs beyond aumolertinib and sugemalimab. We currently have more than 10 ongoing programs, five of which are in the clinic addressing some of the highest cost areas in oncology and immune inflammatory diseases. These other clinical stage programs include nofazinlimab, a PD-1 also known as EQ176 for solid tumors, lerociclib, a CDK4/6 inhibitor for metastatic breast cancer, EQ121, a highly selective JAK-1 inhibitor for immune inflammatory diseases. We plan to provide a more comprehensive update on our clinical stage pipeline during the next quarterly earnings call. In addition to in-licensing, another source of therapy candidates in development is to create molecules from scratch against targets of interest through our early stage R&D collaborations with leading drug engineering companies. We have signed collaboration agreements with now six of the leading drug engineering platform companies, including Exscientia, AbCellera, Relay Therapeutics, Absci, Evotec, and most recently Insilico Medicine. We will leverage each partner's different computational platform approaches for small molecule protein and antibody based drug discovery to create new molecules for EQRx. We believe these collaborations provide a capital efficient way to build our pipeline and will provide sources of revenue in the future. Let me now turn to Slide 8. As I mentioned at the beginning of the call, we continue to make progress in assembling our Global Buyers Club. We're entering into long term trusted strategic partnerships with private and public payers and health systems, so they and the patients they serve can gain access to our future medicines when approved at radically lower prices. In the first quarter, we converted our first memorandum of understanding to a pre-commercialization agreement we have now finalized the details and keep terms of the partnership after establishing a roadmap in the MoU. These terms will then be implemented upon receipt of necessary approvals, which provides for broad access for the partners members. Demand remains strong for high quality innovative medicines at dramatically lower prices. And we look forward to keeping you updated on our progress. I will now turn the call over to Jami to discuss our financial position.

Jami Rubin: Thanks Melanie. I'm now on Slide 9, a summary of our first quarter 2022 financial results can be found in the press release that we issued this morning. More detail is included in our 10-Q filing, which we will file later today. We ended the first quarter of 2022 with approximately 1.6 billion in cash and cash equivalents. Total operating expenses were 86 million versus 27 million for the same period a year ago. R&D expenses accounted for over 60% of our spend this quarter as we continue to advance our portfolio, ramp up clinical trials across all stages of development and build important infrastructure to support our operations. For the full year, we continue to expect 400 million or less in operating expenses, which assumes initiation of comparative studies in the second half of this year. To reiterate Melanie's earlier comment, we are very fortunate to be in an exceptionally strong financial position, which will enable us to grow thoughtfully shape our portfolio and enable us to get through significant development and commercial milestones. We expect to have cash runway into 2025. To that end, we will continue to be disciplined in managing our spend and continuously evaluate our portfolio. That means that we will look to selectively add or advance a pipeline program if it meets our strict criteria of what makes an EQRx medicine. It addresses a high cost burden. It represents a therapeutic area of known and causal mechanism of action. It has potential to demonstrate equal or better clinical evidence to existing drugs in this class. Its patent protected with sufficient patent runway and provides us with the opportunity to capture significant market share. Now, moving to slide 10, I would like to reiterate today's key takeaways and summarize the multiple milestones we are expecting for the remainder of 2022. As you heard during the call today, these include our first regulatory submissions outside the U.S. for aumolertinib and sugemalimab, the planned initiation of our first comparative studies, additional data presentations and readouts, including those at the upcoming ASCO meeting and continuing to add members to our Global Buyers Club. Let me now turn the call back over to Melanie.

Melanie Nallicheri : Thank you, Jami. In closing, I would like to thank all of our employees, partners, and stockholders for your support. We can now go ahead and turn the call back over to the operator so we can take any questions. Operator?

Operator: [Operator Instructions] Our first question comes from Steve Scala with Cowen. Your line is open.

Steve Scala : Thank you, and congratulations on all the progress. I have two questions, first, when we see the GEMSTONE-302 data at ASCO, should we expect median OS to improve or decline versus what was presented at World Lung? And maybe as a second part to that first question more generally, versus data we have seen for aumolertinib and sugemalimab previously, what should be our expectations for data at ASCO? So that's the first question. The second question is based on conversations with FDA so far, is there a maybe small, but non zero chance, further trials won't be needed? And if the chances are zero, then has FDA guided to any particular design. Thank you.

Eric Hedrick : Thanks for the question, Steve. This is Eric. With respect to the first part of your question, GEMSTONE-302, I wouldn't speculate on things relative to previous presentations, the data. But, the overall survival improvement, we believe is robust and compelling, both clinically and statistically, and that's what you should expect to see at ASCO. Regarding, your question about the FDA, we are operating under the premise that we will need to produce additional data to address applicability, right? That's been clear. And part of the process now in discussion with the FDA is defining exactly what that looks like, and it has elements of diversity inclusivity of the U.S. population. It all also has elements of the comparator osimertinib or aumolertinib and other checkpoint inhibitors for sugemalimab. And those design issues, those analysis issues are exactly the subjective conversation with the FDA.

Melanie Nallicheri: And Steve, this is Melanie. I just want to add one comment. As you know, with our unique business model generating additional evidence such as what we are proposing is really helpful when you think about it, both for the physician community and is really helpful for our partners to further their efforts in helping to create that pull through that we have been talking about and creating the adoption. So, there is a reason that goes beyond regulatory for us to do these studies. And we are actually very, very excited about these studies, because we think this is the kind of clinical evidence that many of the stakeholders in our ecosystem are looking forward to.

Operator: Our next question comes from Chris Scott with JP Morgan. Your line is open.

Unidentified Analyst : Great. Thanks so much. Just a couple questions here about the kind of ex-U.S. opportunity given seems like that's going to be where your first filings are coming in. So maybe just first, can you just talk about how quickly you would expect a UK ramp to play out for your medications, assuming all goes well with the filing and approval? I just trying to get my hands around the kind of steps to get reimbursement, then commercialization in place, as I just kind of trying to translate, how we think about second half approvals, and then when we could see kind of relevant commercial revenues coming out of those? And the second question made in the same vein. I know the UK has provided you with an accelerated pathway for the application. As we think maybe more broadly about continental Europe, how attractive of an opportunity are those markets for your products? And are there particular countries we should be thinking about where either the payer or reimbursement systems would be particularly favorable to an EQRx type of model? Thanks so much.

Melanie Nallicheri: Hi, Chris. Good morning. This is Melanie. Thank you for both of these questions. First of all, as you know, as a very young company that has not yet commercialized therapy, I think it would be getting a little bit ahead of over our skis to talk about exactly what our ramp looks like. Having said that, with 65 million lives in the UK and given our Population Health partnership that, we are going to work on with the NHS, we believe that, that is really fertile ground to create much broader access to innovative cancer therapies. And as you know, because we've previously talked about it, in the UK in particular, there's an important strategic goal that the UK has to expand cancer care and to extend cancer survival. And we are a key part of reaching that goal. So, I would say, we all win patients of course, first and foremost, but the NHS and we will equally win if we have a better and faster ramp. And of course, that's what we're hoping for. For your second question on Europe, first of all, let me just put some parameters around your question and then come back to the question around attractiveness. So, if you look at insured lives in the OECD countries alone, then the U.S. is less than 25%, 23% to be exact. Europe is close to 40% and all other OECD countries include another close to 40% of insured lives. So those are really big markets. If you look at it in terms of the number of lung cancer cases, so what I'm quoting now are 2020 new lung cancer cases. The US is at 15% or 14% to 15%. Europe is about a third. APAC, excluding China is about a third, and then you have the Latin American and African markets. So all of that again, to just reinforce that the opportunity in Europe, in particular, which you were asking about is really sizable and very attractive to us. Now, with regards to the question around, in which order, or how would we prioritize them?As you would imagine, you know, size of course matters. But at the same time, what also is important to us and goes back to our mission is that in some of these countries you actually don't have the same choice that we have here in the United States. So in some cases, you may not have as many, or in some cases, no checkpoint inhibitors, or you may not have a third-generation in EGFR inhibitor. So for us, it's also important that we are doing the right thing, and we are bringing an option forward to patients where perhaps today they may not be an option. And that in turn we believe creates opportunity for us because those stakeholders we believe are very -- going to be very interested in what we have to offer.

Operator: Our next question comes from Akash Tewari with Jefferies.

Unidentified Analyst: Hi, this is Amy on for Akash. Thanks so much for taking our question. So just on the head to head trial, can you go over how you're defining the problem you mentioned today that the study is aiming to apply prior generated data to U.S. current medical practice in a diverse population. How are you planning on addressing this in the design of your head-to-head? And additionally, can you kind of go over what the threshold for non-inferiority is for these studies? And if there could be some flexibility on statistics or powerings for these studies.

Eric Hedrick: It's Eric, thanks for the question. I think, -- there's a few things to say, one, we anticipate the trial that will directly compare aumolertinib with osimertinib to initiate in the second half of this year. And obviously that would be posted on clinicaltrials.gov. And that would give you a lot of insight into the specific design details. And come back to the point that again, what these trials are trying to do is address applicability, and applicability has a couple of main components. One is representation of a study population which is representative of the U.S. right. FDA's been pretty clear about that, and so just the composition of the patient population would be one important factor. The second element is comparability, note that I use that term and not necessarily non-inferiority, but comparability to the current standard. And that's an area where I would say there's the most focus on our continuing discussions with the FDA. How is that defined? What does that look like in terms of efficacy? What does that look like in terms of safety? And I think that the design issues here are a little bit more complex than one would see in a study that was just establishing safety and efficacy, which is not the point for these drugs. These are safe and effective drugs. This is about applicability. So I think, the brief answer to your other question is we're looking at both of those elements and the design we're discussing those design issues with the U.S. FDA. We're confident that we'll be able to reach alignment on how comparability and diversity is addressed in the study. And again we're hoping to initiate that study in the second half of this year.

Operator: Our next question comes from Eric Percher with Nephron Research. Your line is open.

Q - Eric Percher : Thank you. Question on the Buyers Club and the move toward commercial agreements, as we see you moving MoU to pre-commercial, what mechanisms are you building into the agreements to drive the poll model that you've talked about? What advantages relative to simply having payer coverage do you see?

Melanie Nallicheri: This is Melanie. As you know, there are a pretty wide range of levers that payers and health systems have at their disposal. All of them are very impactful. There is a slight difference if you look at it from a regional payer point of view in the U.S. to a national payer, to a national payer who may include a pharmacy or PBM business versus for instance an integrated delivery network or a single payer system with universal healthcare coverage. But I would say in all of those, just going back to the fundamentals and the key principles, everybody ends up winning if we see greater adoption. So if we see greater adoption, and they truly create the pull through, then they generate greater savings, because they're effectively replacing a higher cost unit, if you will, by a lower cost unit. Secondarily, we will see a positive impact for patients because one of our important goals is to lower the out of pocket burden for patients where that is an issue such as in United States, perhaps less so in certain European countries. And ultimately, of course, it drives volumes for EQRx. So, the levers may differ ever so slightly, but they are all levers to make it really clear that, it is better to leverage an equally good or better medicine at radically lower prices.

Eric Percher : Okay. And when we look at the pace progress on the development side, have you seen any impact to the pace of commercial development? And I know that early on, you said you had talked to us when there are new type of agreements, and today we have the pre-commercial, but any commentary on increasing penetration of the types you have called out in the past regional, national health system that gets you on the past from 180 million to 350 million lives.

Melanie Nallicheri: Yeah. I'll answer both of these questions, Eric. This is Melanie. First of all, in terms of the pace of progress, part of the reason we wanted to lay out on the slide that we shared how this process works is, because it is a new process and it's a very different process from what we are seeing today or what we have seen up to now in most cases for innovative medicines, where they get developed, they get regulatory approval. And very shortly before that, but then also very much post that regulatory approval, the biopharma company engages with payers and really is focused on getting reimbursement coverage. And that can sometimes take up to 3 months in the United States when P&T committees review these new drugs and make those reimbursement decisions. In our case, it's a really different way of partnering and therefore, the upfront work, if you will, the effort on both parties, by the way, takes more time, because we are starting out with needing to establish very clearly that we are going to be able to prove that, this particular medicine that we are talking about is equally good or better, because of course, nobody would want to make the trade off and have a medicine that is radically lower priced, but not as good. So that's really job one. And that is a really strict threshold for every single one of our EQRx medicines. And that's one of the reasons, why we are pointing to these upcoming presentations at the ASCO Annual Meeting, because all of that additional clinical evidence is important to further establish that. Then as we were talking about the core terms of how we are working together at that memorandum of understanding stage, that is really where we are talking about what is each party's commitment. And I want to stress something. There is the very important commercial component here, but many of our partners have so much more to offer to enable our business model. There are true participants here, because they realize that for instance, if they have clinical evidence or if there is claims data that can be really valuable for us as we are developing our medicines, whereas, we are thinking about what the right pricing approach is, where they have the ability to participate for instance, in our clinical trials, they have the ability to lower our cost of development, which of course further enables us to lowering our prices. So I want to make sure that when we think about these two stages, the MOU stage in the pre-commercialization stage that we understand, that there is a lot that goes into that, and it's not just, here's a price in exchange for reimbursement. And then as you said, this is new, and there's no template for it. So these take some time, but I would say, all in all, we are on a great pace and the pace has continued unabated in the way that we've seen it in 2021. And then Eric, you asked the penetration question. I mean, of course, that's ultimately the goal, and the goal here is to enable as broad a population as possible. And so ultimately, our goal when we've quoted numbers like the 180 million number, that's really important to us. I mean, we are going ultimately after that entire market of insured lives in the OECD countries.

Eric Percher : A quick follow-up there to Chris's earlier question, has there been any change in prioritization of the commercial organization toward Europe relative to the U.S.?

Melanie Nallicheri: Yeah, I would say it the following way, Eric, we feel that we are growing incredibly fast and when you are inside EQRx, it feels like you've stepped into a rocket ship. We are still only 350 people, we need to grow. And we definitely -- I mean, we have a small team now outside of the U.S., but we definitely need to grow that team to be able to support all of the conversations that are ongoing.

Jami Rubin: But Eric, I think just to add to that, we are planning on our first filings outside the U.S. this year, so you can assume that our first revenues will be outside the U.S.. And it's important to understand that because of our radically lower price model, we expect a more narrow pricing corridor. So the prices between the U.S. and Europe won't be exactly the same, but they will be more narrow. So the opportunity for EQRx relative to another biotech is very significant outside the U.S.

Operator: Our next question comes from Chris Shibutani with Goldman Sachs.

Chris Shibutani : Jamie, you're operating as a CFO in an especially challenging environment right now, macro uncertainties, regulatory challenges that the company's trying to address. And yet, also in trying to take a long view, you're also trying to figure out how to build your portfolio. I think at the start of the year, you talked about providing some guidance on how you're looking to really shepherd the company's current healthy balance sheet, but with a name to addressing needs, but also finding the growth. Can you talk about that 400 million? What is embedded within that? How much of that is tied perhaps to the trials that are really front and center for you? How much is possibly earmarked towards the longer-term view on BD?

Jami Rubin: You're right, it is clearly a very challenging capital markets environment, and which is why we feel so fortunate to have such a strong cash position on our balance sheet. We ended the quarter with $1.6 billion in cash. And again, just to reiterate, we expect that cash runway to last through into 2025. So with respect to your specific question on our 400 million or less guidance for the year, first of all, we are more than a third into the year, and we have a very good handle on all of our activities for our level of spend. So with respect to the comparative trials that we expect to begin to initiate in the second half, that is already incorporated in that $400 million number. Second, on your question related to BD, this is clearly an important part of our model. And you can be rest assured that we would only bring in an asset if we believed it would bring significant value to our Global Buyers Club and our shareholders. And we talked about what that criteria is. So yes, we are going to be very prudent with our spending. And if we have to, we will make trade offs. We are constantly evaluating our portfolio. Frankly, we do this if we were in a great capital markets, because that's what a good CFO does. But the bottom line is that we have enough cash to last us through 2025 to help build shape, grow our portfolio, and still be very judicious with our spend.

Chris Shibutani : And linked over to that, particularly on the side they're thinking about doing the discovery work with some of your partners, the artificial intelligence framed companies, such as Exscientia, Recursion, et cetera, that you outlined, I think one of the fundamental tenets of their approach is to do things in a more efficient cost effective sort of a faster, cheaper way. Are you seeing that as an opportunity and any sense for when we might be able to get some of the indications of how progress is going specifically in that regard, both with assets and the efficiencies that you are aiming for?

Melanie Nallicheri: Yeah, Chris, thank you for the question. This is Melanie. As you just said and we agree with that, it is a truly capital efficient way of identifying and actually creating a new molecule with a very clear profile where we can -- where we have the expectation that it's going to perform equally good or better for a particular indication or a set of indications. And so that you will be able to hear more about this over the next couple of years, because as you know, we just got started with those. So I would say stay tuned on those. And on the clinical side, we'll be able -- on the clinical stage portfolio, we will be able to provide more insight and clarity on that in one of our upcoming calls. We wanted to focus today on aumolertinib and sugemalimab, given just how important those are, and of course, the questions that have come up previously around what the path forward is both outside the U.S. and in the U.S.

Operator: Thank you. There are no further questions. I would like to turn the call back over to Melanie for any closing remarks.

Melanie Nallicheri : Thank you so much operator. I would like to thank everybody for joining us today for our first quarterly earnings call. And I just wanted to reiterate we're really excited about the progress that we have continued to make. Our team is firing on all cylinders and on all of the aspects of our business we've continued to make great progress, despite the fact as Chris rightly said, these are challenging times for any biopharma company. And so, we feel that we are in an incredibly fortunate position and we will continue to focus on what's important, and we are looking forward to seeing you at the next call.

Operator: This concludes the program. You may now disconnect. Everyone, have a great day.