Q1 2023 Nautilus Biotechnology Inc. Earnings Call
Speaker 1: Good morning and thank you for standing by. Welcome to the Nautilus First Quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session.
Speaker 1: To ask a question during the session, you will need to press store 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press store 11 again. Please be advised that today's conference is being recorded.
Speaker 1: I would now like to hand the conference over to your speaker today, Carrie Mendoval, Investor Relations. Please go ahead.
Speaker 2: Thank you.
Speaker 3: Earlier today, Nautilus released financial results for the quarter ended March 31, 2023.
Speaker 3: If you haven't received this news release, or if you'd like to be added to the company's distribution list, please send an email to Investor Relations at Nautilus.io.
Speaker 3: Joining me today from Nautilus are Sujal Patel, co-founder and CEO , and Anna Mowry, chief financial officer.
Speaker 3: Nautilus co-founder and chief scientist, Frog Malice, will be joining us for Q&A.
Speaker 3: a Pearson inspection entitled for-looking statements in the press release not-list issue today. Except it is required by law, not-list explains any intention or obligation to update or advise any financial or product pipeline projections or for-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast May 2, 2023. With that, I'll turn the call over to Sujjal. Thanks, Kerry. Good morning and thank you to everyone for joining us today. On this call, we'll share our results for the first quarter and provide an update on recent activities.
Speaker 1: Since our call in February , we've made steady progress towards many of our key scientific and engineering objectives.
Speaker 4: That progress is the result of the outstanding work being done by our talented and dedicated teams in San Carlos, Seattle, and San Diego.
Speaker 4: Every member of the Nautilus team understands that our long-term goal is to provide ubiquitous access to the proteome to every lab, researcher, and clinician around the world. We continue to see this as our long-term purpose, where recognizing the many intermediate benefits that will accrue to biological research and health care.
Speaker 4: as we move towards that ultimate goal. We continue to believe the reach and impact of not only is innovation will be very significant. Recent estimates are that the current annual proteomics market is approximately 27 billion and growing at a 15% tanger.
Speaker 4: While this near-term opportunity is an immediate and exciting area for us to focus, we believe that easy to use high-throughput platforms that match the scale of the proteome, like Nautilus, represents a type of long-term catalyst that holds the potential to expand this market beyond what is currently envisioned.
Speaker 4: We designed the Nautilus Proteo Analysis Platform to, among other things, dramatically accelerate target identification and drug development.
Speaker 4: Using it, weak specular researchers will ultimately be able to quantify proteomes for any samples they wish.
Speaker 4: Armed with that fundamentally new insight, our platform aims to make it easier for those researchers to discover how disease processes impact our bodies and to create drugs that target the molecular underpinnings of each disease.
Speaker 4: We continue to see a broad array of potential users for our platform.
Speaker 4: from researchers in biopharma and academic institutions to clinical practitioners.
Speaker 4: We believe our instrument will fit the needs of a wide range of proteomics users.
Speaker 4: Among these groups, the common thread will be the need to dig deeper and more quickly into proteins and proteoforms of interest.
Speaker 4: We believe that Nautilus will enable them to develop more effective therapies, to build more precise diagnostics, and eventually to pick the best therapy for a particular patient.
Speaker 4: Over the past year, progress has been made in development activities surrounding each of the core components of the platform, including the core reagents, sample preparation methodologies, affinity reagent probes, chips, flow cells, the instruments, and software.
Speaker 4: These activities include hardening our standard operating procedures and improving the scale, quality and performance.
Speaker 4: while also working to define clear specifications for each competitive hardware transform.
Speaker 4: Additionally, progress has been made and advancing our integrated essay towards our product targets.
Speaker 4: In Q1, we made specific progress on several fronts, including
Speaker 4: Advances in our region development, qualification, and manufacturing pipeline.
Speaker 4: This effort not only directly supports our ability to routinely perform experiments involving many thousands of cycles in reagents, but also moves us closer to meeting our product specifications.
Speaker 4: Improving the stability, reproducibility, and performance of our integrated assay across an increasing number of cycles in reagents as we push towards larger scale experiments.
Speaker 4: And finally, it dances in our commercial instrument with a focus on integrating the hardware and software components of the platform. We also made good progress on actively identifying, developing, and qualifying multiple sources, both internal and external, for key reagent production and instrument assembly capabilities.
Speaker 4: as we build towards and prepare for full commercial availability.
Speaker 4: for full commercial availability. And.
Speaker 4: Building on the near doubling of our patent portfolio in 2022, we added five new patent applications in Q1 and were granted four new U.S. patents, raising our total to 12 granted U.S. patents.
Speaker 4: Our IP strategy will remain global and reached as we seek protection in the US and in foreign markets where we expect to commercialize our platform.
Speaker 4: On our last call, we shared our excitement for our first access challenge, a contest designed to enable researchers from a broad spectrum of disciplines to uncover new biological insights and explore new areas of the proteome at massive scale.
Speaker 4: The response from researchers across the globe to the FIRST Access Challenge was incredibly rewarding.
Speaker 4: It unlocked the type of creativity we hope to see when we offered them the chance to apply Nautilus's novel platform to ask and answer important biological questions.
Speaker 4: Research groups from a dozen countries across North America, Europe , and Asia submitted grant-like applications to participate.
Speaker 4: In reviewing the submissions, it was clear that each of them understands how important single molecule intact protein analysis and the resulting sensitivity and dynamic range that our platform is designed to deliver can be to their explorations of the proteome.
Speaker 4: The applications covered a wide variety of research areas, including oncology, neuroscience, kidney disease, and inflammation across human tissues, cell lysates, blood, serum, and cerebral spinal fluid.
Speaker 4: They also included some of the top research laboratories and pioneers in our field, which is an encouraging indication that the broader proteomics community is excited about what we are building and understands the potential of our platform.
Speaker 4: The winners announced that the US Hupo conference in early March and who samples will be run as part of our Early Access program represent the first set of investigators spanning a wide range of exciting areas of study across aging, inflammatory disorders, and cancer.
Speaker 4: Dr. Stuart Abond and Jordan Burton post-utctoral research scientist in the Schilling lab at the Buck Institute for Research and Aging will use our platform to investigate total proteome remodeling in acute kidney injuries of a Schemic Reprefusion injury and Cisplatin Indies K.I. to identify potential biomarkers or therapeutic targets.
Speaker 4: Dr. Samuel Payne, Associate Professor at Brigham Young University, will apply our platform to analyzing a three-dimensional lung alveolar organized model to better understand the system's biology of organoids and potential applications to the pathology of human diseases.
Speaker 4: And Dr. Nicholas Graham, associate professor at the University of Southern California, will use Nautilus' platform to identify protein biomarkers of sensitivity to arginine deprivation-induced cancer cell death, aiming to enable a deeper understanding of metabolic vulnerabilities in glioma, a type of aggressive primary brain tumor.
Speaker 4: We've always envisioned our platform as one of great interest to researchers across the spectrum from small undergraduate institutions to large pharmaceutical companies. The participants in our first access challenge, along with existing collaborations with Genentech, Amgen, MD Anderson, and Pee Gen.
Speaker 4: A moment ago, I mentioned that the U.S. human proteome organization conducted their annual conference in early March. Nautilus had a focused and effective presence at the event. Designed to both educate the community about the underpinnings of our technology and to encourage that community to reimagine what's possible in proteomics. From our field to capacity, our long luncheon seminar to our four-postor and proteome presentations, non-less scientists led by broad shared insights on topics such as...
Speaker 4: The theoretical foundations of our protein identification by short epitope mapping methodology commonly referred to as Prism. Data demonstrating the beginning to end instantiation of prism, spanning from sample preparation to multi-facal measurement to the machine learning analysis that enables the translation of those measurements into the identification of model proteins. Additionally, we introduced the rigorous strategies that we've built and are now routinely employing for estimating false discovery rates and for investigating the robustness of protein identification.
Speaker 4: This unusual transparency among new entrants in our market was very well received by the community and underscored our commitment to building long-term trust and scientific credibility.
Speaker 4: Parag and all the notalypes in attendance engaged in conversations with researchers, many of whom are current mass spec users, excited to know more about the potential of our platform to complement their existing workflows and address their unmet needs. We see the positive attention our presence at HUPO received as a good sign for things with respect to our platform.
Speaker 4: Party our mayor for the community
Speaker 4: We're excited to get our platform into the hands of researchers and see the type of impact their work can have on biology and healthcare.
Speaker 4: As I mentioned on our last call, in 2023, we will continue to make steady progress in addressing key scientific and business milestones leading to the planned launch of our platform, instruments, reagents, and software in mid-2024.
Speaker 4: A critically important part of that effort is the discipline and efficient way in which we have and we will continue to manage our resources to maximize Nautilus' cash runway through the planned launch and well into 2025.
Speaker 4: We are successfully balancing financial and operational efficiency with appropriate levels of investment in key areas that will enable us to drive our scientific progress forward.
Speaker 4: One area in which we are investing without overexcending is in hiring. We're excited that Nautilus' culture, mission, and product value proposition continue to attract the attention of some of the best and brightest scientific minds in the proteomics space.
Speaker 4: They and others understand, as we do, that when you look across the landscape of our sector, Nonwis is a unique company on a path to revolutionize biomedical research by unlocking the full potential of the podium.
Speaker 4: They see what we're doing and want to participate in revolutionizing biomedical research. We will continue to take full advantage of this valuable and timely opportunity to increase the strength and experience of our team across the board.
Speaker 4: For a look at our Q1 financials.
Speaker 4: financials. Let me hand the call over to Anna.
Speaker 3: Anna? Thanks, Sujal. Total operating expenses for the first quarter of 2023 were $18.1 million, up $2.1 million compared to the first quarter of 2022, and $1.8 million above last quarter.
Speaker 3: This increase is largely driven by an uptick in the pace of hiring as we continue to invest in the development of our platform. Research and development expenses for the first quarter of 2023 were $10.9 million compared to $9.7 million in the first quarter of 2022.
Speaker 5: General and administrative expenses were $7.2 million in the first quarter of 2023, compared to $6.4 million in the first quarter of 2022.
Speaker 5: Overall, net loss for the first quarter of 2023 was $15.0 million, compared to $15.8 million in the first quarter of 2022. Now, turning to our 2023 guidance.
Speaker 5: On our last call, we stated that we expect our overall operating expenses to be up approximately 40% from 2022 levels, ahead of a more meaningful ramp in 2024 along with our commercial launch.
Speaker 5: As we've consistently said, we are continuing to invest in the business, but in a conservative, intentional manner.
Speaker 5: That will continue over the remaining quarters of 2023. Finally, turning to our balance sheet, we ended the quarter with approximately $302 million in cash, cash equivalence and investment, compared to $314 million at the end of last year.
Speaker 5: While we expect that our cash burn will increase going forward, we continue to anticipate our cash runway extending well into 2025. We believe this puts us in a strong position to focus on our scientific progress and to deliver the type of platform that we believe will enable our customers to achieve new levels of proteomic insight.
Speaker 5: While we expect that our cash burn will increase going forward, we continue to anticipate our cash runway extending well into 2025. We believe this puts us in a strong position to focus on our scientific progress and to deliver the type of platform that we believe will enable our customers to achieve new levels of proteomic insight. With that, I'll turn it back to Sue-Jal.
Speaker 4: Thanks, Nana. We're excited about what life ahead for NONLIS and the different short platform aims to make in biological science and healthcare.
Speaker 4: Our mission to possibly impact the health and lives of people around the world remains our guiding light. I'm grateful to our investors, our strategic partners, our research collaborators, and our team for joining us on this journey to transform proteomics.
Speaker 4: and empower the scientific community in ways never before thought possible. We continue to make solid and steady progress and look forward to updating all of you along the way as we move towards commercialization of our platform and beyond.
Speaker 4: With that, I'll turn the call back to the uprhythm. Uprhythm?
Speaker 1: As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced.
Speaker 1: To withdraw your question, press star 11 again.
Speaker 1: Please stand by while we compile the Q&A roster. The first question comes from Tejas Savon with Morgan Stanley . Your line is now open.
Speaker 6: This is Yucle on Verteges. Thank you for taking our questions.
Speaker 6: Thank you, Susan, for providing color around the winning projects of the first access challenge. How do you anticipate each of these projects will specifically highlight and demonstrate the differentiated capabilities in the NOTALIS platform?
Speaker 4: Yeah, they still actually passed that question over to Perot who's got a lot of detail on our perspective, Challenge Writers.
Speaker 7: Super, it's a great question. I think when we were looking at the projects, we were very excited by the range of questions being asked across different medical domains. We were also excited by the different types of materials being studied. So as Sujal mentioned, one of the...
Speaker 7: One of the projects is using a really unique and interesting organoid model and that particular project really helps demonstrate both the diversity of types of materials that will be able to work with the sensitivity of the platform as well as the dynamic range.
Speaker 7: to look at important questions. One of the other areas that we're excited about is the incorporation of multiple different types of data together, so Nautilus bringing a proteomics component to other multi-omic, multi-data studies. And so when one looks at the study, for instance, from Nick Graham's lab, looking very specifically at metabolism...
Speaker 7: it's a really interesting opportunity to bring together proteomics and metabolomics data. Some of the other key aspects of the platform that we're seeing stretched are really the breadth and scale to be able to look more deeply, more wildly, more...
Speaker 7: reproducibly, those are really key aspects that all of the projects are going to leverage.
Speaker 6: That was really helpful, Color. Thank you. As a separate follow-up, I wanted to follow up with a high-level question. Clinical market is clearly a very large opportunity for proteomics. Where do you think that current biology is in supporting multi-analyte proteomics?
Speaker 6: Do you think the clinical market is receptive to that kind of thinking or do you think that more education will be needed to get folks fully on board and finally what attributes with the next program is platform do you think are the most important in driving that penetration
Speaker 4: Yes, maybe I'll tackle this one and then see if the program any comments to add this is usual. So I think that...
Speaker 4: If you look at the importance of proteomics today across the biomedical research spectrum, you can talk about translational research leading to a clinical application, the imagined you know, in pharmaceuticals all 90% of our proteomicers that drugs target our proteins.
Speaker 4: Even with this massive revolution over the last decade in liquid biopsy, most diagnostics are still protein targeting diagnostics. And so as we talk to customers who are potential customers who are building diagnostics, we hear a tremendous amount of interest in being able to have a much more complete picture of the proteome. And a much more complete picture is not just...
Speaker 4: hey, I have a technology that can see all of the proteins in the sample, which I can't see today, but also that I have the dynamic range and the sensitivity to dig deeply into samples like blood serum and pick out rare biomarkers that are in those samples in very, very small quantities. And so we think that...
Speaker 4: supporting the translational research that builds these diagnostics and gets them into the clinics is really an important part of our strategy and will be a big business driver.
Speaker 4: Now, recall our strategy is to play in the research-only market for at least the medium term here. And so what that means is we will go to fellow platform and consumables to accompany them in a diagnostic. They'll make a breakthrough. They'll realize that this combination of a genomic marker and these four protein biomarkers...
Speaker 4: is indicative of a therapeutic response and will participate in the discovery, but then let them go to high throughput assay that goes and takes that test into the clinic where it can do good for patients. Now in the longer term, certainly some of these combinations of biomarkers may become so complicated and we expect it will become so complicated.
Speaker 4: that really you need an instrument like Nautilus in order to be able to do that analysis. And we would view that as that.
Speaker 6: type of catalyst that would want to make us invest in the regulatory path to create a clinical offering. But really that's more of a five to seven year after launch type of vision. Great, that was super helpful, thank you. And one more, could you also provide a progress update towards the internal development of the multi affinity pros?
Speaker 6: commercialization expected in mid-24? Yeah, probably. You want to take this one?
Speaker 7: Sure, I think we've been making really fantastic progress as we noted in previous calls.
Speaker 7: We've built a very substantial team and program around multi-assignity probe development. A key aspect of that was increasing the scale by which we could make them, increasing the quality. We've also been working with outsourcing partners in that area.
Speaker 7: for producing the multi-finity probes as well to further accelerate our pipelines. So we're really pleased with the progress of those efforts and of the team that has done just a remarkable job of building.
Speaker 1: a great pipeline. Thank you. Please stand by for our next question.
Speaker 1: The next question comes from Daniel Brennan with Cohen. Your line is now open.
Speaker 8: Great, thank you. Thanks for taking the questions. Congrats on the quarter. Maybe just the first one, just on the early access. I don't know what you specifically shared in the past, but how do we think about...
Speaker 8: kind of a number of customers that we should expect to kind of get into that early access and when you think about the key deliverables from where you sit today versus
Speaker 8: Actually opening that early access what I like to I'm sure there's 50 things that you're working on, but there are a handful of key improvements that still need to be made in order to. Launch early access on time.
Speaker 4: Yes, so this is Sujol and I'll tackle this one. Dan welcome you, first not with any calls here. So the early access program is really a first chance that customers will have to test out our technology. And so this is a service offering that will be...
Speaker 4: provide its customers ahead of our commercial watcher our consumers. And we think that these engagements will probably be pretty programmatic types of engagements, maybe 12 or 48 samples. And the first customers through our early access program will be the existing collaborations that we have today, largely that we've announced.
Speaker 4: then as well the winners of our first access challenge. If you kind of think about that, that's a small handful of potential customers. I don't have an exact number for you for how many more will join it, but you should think about something roughly in the range of that many number of customers or maybe up to a dozen. It's kind of our initial focus as we go and get that early access program out there.
Speaker 4: And the only access program is not just about generating a little bit of revenue and learning about how the performance is in the hands of customers, but most importantly, that program is about showing the scientific community the data coming off of.
Speaker 4: this very novel platform, and as well, driving pre-orders with a significantly improved data center for anything else that's out there. And so those are the major goals of that program. We have not announced...so the only guidance we've provided in terms of timelines is a mid-2024 launch of our commercial platform.
Speaker 4: We haven't provided any intermediate guidance to when that Early Access Program will start, but once we're able to identify a meaningful number of proteins with single molecule sensitivity and all the things our platform is designed to do, we can do that in a repeatable, reliable manner with a very good type coefficient of variance. We will go and use that as kind of our indication that we're going to kick off those Early Access Programs.
Speaker 8: When you do ultimately launch in 2024, have you shared the scale of that launch? Presumably, it's going to be pretty gated, given the uniqueness of the platform. And you're working with a lot of different factors to get this commercial product up and running. I'm just kind of wondering.
Speaker 8: You know, when when that starts, I can see what consensus numbers are roughly like 20 million and 24 and call it high 70s and 25. just wondering if you've given any color about. You know, the, you know, the type of kind of piece of that full commercial launch.
Speaker 4: Yeah, that's a good question, Dan. We have not given any.
Speaker 4: with respect to what the revenue, the launch rate, the liftoff rate will look like, and we haven't really gone and provided any color on the estimates that you noted are in the consensus today. What I will tell you is that we've spent a lot of time looking at the...
Speaker 4: to lift off our revenue run rate with some acceleration. Number one is that we have a early access program ahead of our commercial launch that is really designed to show the scientific community the very unique and very valuable data that's coming up on our platform. Thank you again.
Speaker 4: Some of the recent launches of other new companies in the EXC and Toolspace, many of them don't have as robust programs out of their launch. I can think of two in particular where there was just one paper source of data from one study and the other had no data out of launch. So I think that that early access program.
Speaker 4: goals for us to be able to start to generate meaningful revenue and as well unlike many other
Speaker 4: platforms in DX and tools, we have an existing budget pool to go after, which is the proteomic solutions that are in the customer's hands today. And through conversations with hundreds of potential customers, we know that the specifications of what we're building are highly desired and viewed.
Speaker 4: extremely differentiated from the products that are in the marketplace today. So that product market fit we think as well, deals to a good successful launch once we complete development of the platform. Terrific, thanks a lot and congrats.
Speaker 4: So that product market set we think as well you're good successful launch once we complete the development of a platform. Perfect, thanks a lot Congrats.
Speaker 1: Please stand by for our next question. The next question comes from Matt, Sikes with Goldman Sachs, your line is now open.
Speaker 8: Hey, good morning. Thanks for taking my questions. Maybe Sudo just to start on your comments and the prepared remarks about looking for additional suppliers on the reagent and instrument assembly capabilities. You just give a little bit more color on kind of where you stand with the supplier base and how comfortable you are.
Speaker 4: in terms of the potential risk there in terms of sole supplier versus multi-suppliers or dual suppliers. Yeah, good question Matt and then, Matt, we do hear this morning. So let me tackle this in two pieces. I'll tackle it first on the instrument side and then I'll tackle it on the consumable side.
Speaker 4: the actual instrument builds, providing us with a significant scale capability. It's a partner we know well, we've been working with. We feel good about the manufacturing capabilities, calling you on that front. In terms of the instrument itself, as I've said on previous earnings calls, there's not a lot of.
Speaker 4: source types of issues within the instrument. There's maybe a couple of components where I would say that the release of those components are not super rare, but it would take us some time to qualify a replacement. So we do maintain other sensitive components, maintain some stock of them. But you know, to see that that's not material with dollars because
Speaker 4: As we've said, all of our revenue streams are hyper-smart and it's you can imagine any individual parts, not a really big ticket item. And so from that standpoint, I think we're really comfortable with the strategy. And I would say that there's not a lot of additional supply or type of work going on there. Now turning my attention to the consumables.
Speaker 4: On the ship and flow cell side, which is a key part of the consumables as well, on that front, we have our suppliers selected, we've made good progress in terms of establishing quality metrics and scaling up. We have our assemblies going through some changes as we move towards finalizing them.
Speaker 4: but all in pretty good shape on that front. And then on the reagent side, that scenario, that's the area where an upper part of the marks were referring to continuing to go and work with suppliers and working on scale. And so for those reagents, there are things that are pretty standard, fairly easy types of reagents, like the bulk reagents that are in the instrument.
Speaker 4: kit, for example. And those are the sorts of things where we can have multiple partners to have those, the creation of those reagents. And we have some today and we continue to add partners on that front. And that's, there's little risk there. On the other side of the reagents is really the creation of our antibodies. And we have our own internal manufacturing of our actual organization.
Speaker 4: on that front. And so I'd say that hopefully that gives you a little bit of color where things are at on those various pieces. But certainly our goal on the consumable side is to have a very robust strategy like we do on the instrument chip.
That's really helpful, Collar. Thanks, Sujul. And then just as you think about...
customer exposure when we get closer to launch. Just given the sort of the depth and breadth of the technology, it would seem to lend itself to sort of unbiased, maybe academic type work, but I know you have obviously a partnership with Genentech and others, and you've talked a little bit about the bio-farm opportunity in clinical...
Do you expect that cadence to be kind of similar to what others have done in the past? So, I've talked about this a little bit in the past and I think that...
There are a few lessons to be learned from history here in terms of where new entrance starts. I think that if you look at the companies that start in academic and research and non-profit types of research organization, they fall into two camps usually. If you take a lesson from the NGS world when Luminina brought the GA and GA2, J2,
In the conversations we've had with biopharma, the type of dynamic range and sensitivity combined with complete coverage of the proteome provides a game-changing data set. And with that, we see a ton of interest from biopharma predominantly with academic and research as kind of the supporting market. And so I think that, I think ourselves will be pretty, will be pretty consistent across both of those areas pretty quickly after we launch. And so I don't think we'll have that pronounced effect where it's all academic and research and then we have to expand out from there.
Got it, thanks. And just one more for Anna. Thank you for the color I know you provided before about the OPEX increase 23 over 22. If I could ask you to maybe think about as we get closer to launch, is a lot of that increase in OPEX this year in preparation for a launch, and so sort of the OPEX increase that we might see in 24.
the balance sheet would look like in order for you to kind of take advantage of sort of the early traction that you might have in 24 and having the cash available to do that. Matt, thanks for the question.
We are still very much a development focused organization, so this year the majority of our spending is going, continuing to go towards R&D hires, R&D types of activities. Towards the end of the year we'll certainly do some targeted market development activities, but for the most part, our commercial expansion.
is anticipated to be or at least be felt in the operating expense line more into 2024. With a cash balance of $302 million at the end of this quarter, last quarter we burned $12 million. We've got significant runway, which is why we think...
In a range of scenarios, we have cash well into 2025, and certainly through commercialization. I do think that means, though, that the growth in expenses in 24 will still continue to be meaningful, and probably a similar or higher level, than what we see in 23.
Thanks, Anna. Thanks for taking my questions. I show no further questions at this time. This concludes today's conference call. Thank you for participating. You may now disconnect.
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