NAUT - NASDAQ

Good morning and thank you for standing by. Welcome to the Nautilus First Quarter 2023 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would not like to hand the conference over to your speaker today, Carrie Mendivil, Investor Relations. Please go ahead.

Thank you. Earlier today, Nautilus released financial results for the quarter ended March 31, 2023. 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 e-mail to [email protected]. Joining me today from Nautilus are: Sujal Patel, Co-Founder and CEO; and Anna Mowry, Chief Financial Officer. Nautilus Co-Founder and Chief Scientist, Parag Mallick, will be joining us for Q&A. Before we begin, I'd like to remind you that management will make statements during this call that are forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Additional information regarding these risks and uncertainties appears in the section entitled "Forward-Looking Statements" in the press release of Nautilus issued today. Except as required by law, Nautilus disclaims any intention or obligation to update or revise any financial or product -- pipeline projections or forward-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 Sujal.

Thanks, Carrie. 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. Since our call in February, we've made steady progress towards many of our key scientific and engineering objectives. That progress is the result of the outstanding work being done by our talented and dedicated teams in San Carlos, Seattle and San Diego. 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, while recognizing the many intermediate benefits that will accrue to biological research and healthcare as we move towards that ultimate goal. We continue to believe the reach and impact of Nautilus' innovation will be very significant. Recent estimates are that the current annual proteomics market is approximately $27 billion and growing at a 15% CAGR. 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 catalysts that hold the potential to expand this market beyond what is currently envisioned. We've designed a Nautilus Proteome Analysis Platform to, among other things, dramatically accelerate target identification and drug development. Using it, we expect researchers will ultimately be able to quantify proteomes for any samples they wish. 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. We continue to see a broad array of potential users for our platform. From researchers in biopharma and academic institutions to clinical practitioners, we believe our instrument will fit the needs of a wide range of proteomics users. Among these groups, the common thread will be the need to dig deeper and more quickly into proteins and proteoforms of interest. 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. 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 instrument and software. These activities include, hardening our standard operating procedures and improving the scale, quality and performance, while also working to define clear specifications for each component of our platform. Additionally, progress has been made in advancing our integrated assay towards our product targets. In Q1, we made specific progress on several fronts, including advances in our reagent development, qualification and manufacturing pipelines. This effort not only directly supports our ability to routinely perform experiments involving many dozens of cycles and reagents, but also moved us closer to meeting our product specifications. Improving the stability, reproducibility and performance of our integrated assay across an increasing number of cycles and reagents, as we push towards larger scale experiments. And finally, advances in our commercial instruments 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 as we build towards and prepare for full commercial availability. And building on the near doubling of our patent portfolio in 2022, we added 5 new patent applications in Q1, and were granted 4 new U.S. patents, raising our total to 12 granted U.S. patents. Our IP strategy will remain global and reached as we seek protection in the U.S. and in foreign markets where we expect to commercialize our platform. 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. The response from researchers across the globe to the First Access Challenge was incredibly rewarding. It unlocks the type of creativity we hope to see when we offered them the chance to apply Nautilus' novel platform to ask and answer important biological questions. Research groups from a dozen countries across North America, Europe and Asia, submitted grant-like applications to participate. 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. The applications cover a wide variety of research areas, including oncology, neuroscience, kidney disease and inflammation across human tissues, cell lysates, blood, serum and cerebrospinal fluid. They also included some of the top research laboratories and pioneers in our field, which is an encouraging indication that the broader proteomic community is excited about what we are building and understand the potential of our platform. The winners announced that the U.S. HUPO Conference in early March and whose samples will be run as part of our Early Access program, represents a diverse set of investigators spanning a wide range of exciting areas of the study across aging, inflammatory disorders and cancer. Doctors Joanna Bons and Jordan Burton, postdoctoral research scientists in the Schilling Lab at the Buck Institute for Research on Aging, will use our platform to investigate total proteome remodeling in acute kidney injuries of ischemic-reperfusion injury and cisplatin-induced AKI to identify potential biomarkers or therapeutic targets. Dr. Samuel Payne, Associate Professor at Brigham Young University will apply our platform to analyzing a 3-dimensional lung alveolar organoid model to better understand the systems biology of organoids and potential applications to the pathology of human diseases. 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. 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 TGen, are reflective of the broad set of use cases, our collaborators, partners and future customers envision for our platform. I'm pleased that we've been successful in building a balanced portfolio of relationships that reinforce our stated goal of democratizing access to high-value proteomic data. 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 fill-to-capacity hour-long lunch seminar to our poster and podium presentations, Nautilus scientists led by Parag, shared insights on topics such as 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-cycle 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 identifications. 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. Parag and all the Nautilites [ph] 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 HUPA received, as a good sign for things to come with this critically important and influential buying audience. Based on what we heard at HUPA and from many other conversations in Q1, I believe more than ever that the Nautilus platform is going to spur tremendous creativity and innovation in the broader proteomics community. 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. 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. A critically important part of that effort is the disciplined 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. We're successfully balancing financial and operational efficiency with appropriate levels of investment in key areas that will enable us to drive our scientific progress forward. One area in which we are investing, without overextending 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 proteomic space. They and others understand, as we do, that when you look across the landscape of our sector, Nautilus is a unique company on a path to revolutionize biomedical research by unlocking the full potential of proteome. They see what we are 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. For a look at our Q1 financials, let me hand the call over to Anna. 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. 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. 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. 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. 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. As we've consistently said, we are continuing to invest in the business but in a conservative intentional manner. 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 equivalents and investments, compared to $314 million at the end of last year. 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 Sujal.

Thanks, Anna. We're excited about what lies ahead for Nautilus and the difference our platform aims to make in biological science and healthcare. Our mission to positively 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 and empower the scientific community in ways never before I 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. With that, I'll turn the call back to the operator. Operator?

[Operator Instructions] The first question comes from Tejas Savant with Morgan Stanley.

Hi, this is Yuko on for Tejas. Thank you, Sujal, for providing color around the winning projects for the First Access Challenge. How do you anticipate each of these projects will specifically highlight and demonstrate the differentiated capabilities in the Nautilus platform?

Yes. Maybe I'll actually pass that question over to Parag, who has got a lot of detail on our First Access Challenge there [ph].

Yuko, 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 are also excited by the different types of materials being studied. So as Sujal mentioned, 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 we'll be able to work with the sensitivity of the platform as well as the dynamic range 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 with Nautilus, bringing the 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, 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 our -- really, the breadth and scale to be able to look more deeply, more widely, and more reproducibly, those are really key aspects that all of the projects are going to leverage.

Great. That was really helpful color. And then 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? And 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 onboard? And finally, what attributes of the Next-Gen Proteomics platform do you think are the most important in driving that penetration?

Yes. Maybe, I'll tackle this one and then see if Parag has any comments to add. This is Sujal. So I think that if you look at the importance of proteomics today across the biomedical research spectrum, talking about translational research leading to those clinical applications, imagine in pharmaceutical development, 90% of our proteo -- or biomarkers that drugs target are proteins, 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 or 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 much more complete picture is not just, "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 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. 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 and sell our platform and consumables to a company developing [ph] diagnostic, they'll make a breakthrough, they'll realize that this combination of a genomic marker and these 4 protein biomarkers is indicative of a therapeutic response, and we'll participate in the discovery, but then let them build a high-throughput assay that goes and takes that test into the clinic, where it gives you 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 that really you need an instrument like Nautilus' in order to be able to do that analysis. And we would view that as the type of catalyst that would -- one can make us invest in the regulatory path to create a clinical offering. But really, that's more of a 5-year to 7-year after launch type position.

Great, that was super helpful. And one more. Could you also provide a progress update towards the internal development of the multi-affinity probes with commercialization expected in mid-'24?

Yes. Parag, do you want to take this one?

Sure. I think, we've been making really fantastic progress. As we noted in previous calls, we've built a very substantial team and program around multi-affinity 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 for producing the multi-affinity probes as well to further accelerate our pipeline. So we're really pleased with the progress of those efforts and of the team that has done just a remarkable job of building a great pipeline.

Please stand by for our next question. The next question comes from Daniel Brennan with Cowen.

Maybe just the first one, just on the Early Access. I don't know what you've specifically shared in the past, but how do we think about kind of the 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 actually opening that Early Access, what are like the -- I'm sure, there is 50 things that you're working on, but are there a handful of key improvements that still need to be made in order to launch Early Access on time?

Yes. So, this is Sujal, and I'll tackle this is one. Dan, welcome to your first Nautilus earnings call here. So the Early Access program is really the first chance that customers will have to test out our technology. And so, this is a service offering that will be provided to customers ahead of our commercial launch of our instrument. 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, margins that we've announced, and 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. And I don't have the exact number for you or how many more will join it. But you should think about something roughly in the range of that many number of customers or maybe upto a dozen of kind of our initial focus as we go and get that Early Access program out there. And the Early 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 this very novel platform and as well driving preorders 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. 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 and we can do that in a repeatable, reliable manner with a very good type cohesion of variants; we will go and use that as kind of our indication that we're going to kick-off those Early Access programs. And really, I think that when we talk to investors, we really tell them to watch for the announcement of that with the scientific community, because that's probably the same catalyst that many investors are looking for that really show our progress towards that in '24 onwards [ph].

Got it, great. And then maybe the second one, just when you do ultimately launch in 2024, have you shared like 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 kind of get this commercial product up and running. I'm just kind of wondering when that starts, I can see what consensus numbers are roughly like $20 million in '24, call it, high-70s in '25. Just wondering, if you could give any color about the type of kind of pace of that full commercial launch?

Yes. That's -- it's a good question, Daniel. We have not given any formal color with respect to what the revenue run rate or the launch rate, the lift off rate will look like, and we haven't really gone and provided any color on the estimates that you noted are in consensus today. What I will tell you is that, we spend a lot of time looking at the launches of many of the pure proteomics new names out there as well as we spent time looking at the wider Dx and tool space. And there are two things about our strategy that I think are, for me, personally focused on trying to lift off our revenue run rate with some acceleration. Number one is that we have an 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 off of our platform. And if you look at some of the recent launches of other new companies in the Dx and tool space, many of them don't have as robust programs out of their launches. I can think of 2, in particular, where there was just one paper's worth of data from one study and the other had no data ahead of launch. And so, I think that, that Early Access program designed for us is really to help us accelerate once we get that -- once we get to commercialization. The second thing that's important to remember is that the instrument deal for us is roughly a $1 million deal. And so, it takes less salespeople, it takes less sales cycles for us to be able to start to generate meaningful revenue. And as well, unlike many other platforms and 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 extremely differentiated from the products that are in the marketplace today. So that product market fit, we think as well to a good successful launch once we complete development of the platform.

Terrific.

Please stand by for our next question. The next question comes from Matt Sykes with Goldman Sachs.

Maybe Sujal, just to start on your comments in the prepared remarks about looking for additional suppliers on the reagent and instrument assembly capabilities. Could you just give a little bit more color on kind of where you stand with the supplier base? And how comfortable you are in terms of the potential risk there in terms of sole supplier versus multi-suppliers or dual suppliers?

Yes, it's a good question, Matt. And nice comparison this morning. So let me tackle this in 2 pieces. I'll tackle it first on the instrument side, and then I'll tackle it on the consumable side; and consumables breaks up one more time between chip and flow cell, and then the actual reagent. On the instrument side, we have a well-known and large manufacturer who is going to be our contract manufacturer and help us with the actual instrument builds providing us with a significant scale capability. That is a partner we know well, we've been working with. We feel good about the manufacturing capabilities, the quality on that front. In terms of the instrument itself, as I said on previous earnings calls, there is not a lot of sole source types of issues within the instrument. There is maybe a couple of components where I would say that the key derivatives of those components are not super rare, but it would take us some time to qualify as a replacement. And so, we do maintain -- of the sensitive components, maintain some stock of them. But you don't see a -- that's just not material in dollars because as we've said, all of our revenue streams are high gross margin. And so, 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 is not a lot of additional supplier type of work going on that. Now, turning my attention to the consumables. On the chip 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, but all in pretty good shape on that front. And then on the reagent side, that's an area -- well, that's the area where in our prepared remarks, we 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 in are the instrument kit, for example. And those are the sorts of things where we can have multiple partners to outsource those -- the creation of those reagents, and we have some today, and we continue to add partners on that front. And there is little rig there. On the other side of the reagent is really the creation of our antibody. And we have our own internal manufacturing organization, which can build antibodies. We already have more than one external partner, which is capable of producing antibodies. But we need to move those partners to manufacturing scale, manufacturing SOPs, manufacturing quality. And then as well, we continue to think about new partners to add 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 consumables side is to have a very robust strategy like we do on the instruments [ph], chip and flow cell side.

Got it. That's really helpful color. 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 it would 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 biopharma opportunity and clinical opportunity. But could you just maybe help us understand a little bit sort of early adopters? Do you think that, that will, similar to other types of tools companies, that they have started out to start in the academic arena and then expand outward more towards biopharma translational and clinical? Do you think, do you expect that cadence to be kind of similar to what others have done in the past?

So, I've touched about this a little bit in the past. And I think that there are -- there's a few lessons to be learned from history here in terms of where new entrants start. I think that if you look at the companies that starts in academic and research, and nonprofit types of research organizations, they fall into 2 camps usually. If you take a lesson from the NGS world, when Illumina brought the GA, and GA II and GA IIx to market in '07, '08, the early customers were all academic and nonprofit research. The genomics market really didn't exist. Nobody knew what to deal with a complete human genome. And so those applications started invasively search, and they were slow to move up to biopharma. And if you think about, well, when does that happen in today's world? In today's world, companies that start academic and research are those that usually have point solutions for a small improvement somewhere in the workflow, as opposed to a platform that's a fundamental game changer for the customer. 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, our sales 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 towards all academic and research and then we have to expand them from there.

Got it. And just one more for Anna. Just, 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 launch? And so, sort of the OpEx increase that we might see in '24 is either similar or maybe even more modest given that you're probably doing some upfront spending to prepare for that? I'm just trying to get a sense for that cash runway that you say that's well into 2025, but just sort of on a post-launch basis, how 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 questions. 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, higher 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 a 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 levels than what we see in '23.

Got it.