Maravai LifeSciences Holdings, Inc.

and welcome to the Maravai Life Sciences Q1 2025 Results Earnings Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. You may register to ask a question at any time by pressing star 1 on your telephone keypad. We ask that you please limit yourself to one question and one follow-up. Also, today's call is being recorded, and if you should need any operator assistance during the call today, please press star 0. Now, at this time, I'll turn things over to Ms. Deb Hart, Head of Investor Relations. Please go ahead, ma'am.

Good afternoon, everyone. Thanks for joining us for our first quarter 2025 earnings call. Our press release and the slides accompanying today's call are posted on our website and available at investors.moravai.com. As you can see from our agenda for today on slide two, Trey will first provide you with a business update, and Kevin will review our financial results and guidance. Becky Buzio, our Chief Commercial Officer, will join the call for the question and answer session following the prepared remarks. During today's call, management will make forward-looking statements and refer to GAAP and non-GAAP financial measures. It's possible that actual results could differ from management's expectations. We refer you to slide three for more detail on forward-looking statements and our use of non-GAAP financial measures. Our just-issued press release provides reconciliations to the most directly comparable GAAP measures, and we also post reconciling schedules to the IR website. Please also refer to Moravai's SEC filings for additional information on risks and uncertainties that may impact our operating results, performance, and financial condition. Now I'll turn the call over to Trey.

Thank you, Deb, and good afternoon, everyone. We appreciate having you join us for the call today. I will summarize our Q1 revenue results and provide commentary on tariff and trade dynamics. I'll then showcase some of the innovative technologies we've launched and share business updates, including progress on the integration of our two recent acquisitions, before handing the call back over to Kevin. Let's start with our first quarter results on slide five. Today, we reported $47 million in revenue for Q1. This exceeded the range of expectations we shared with you during our fourth quarter conference call, and we're pleased with the base business growth of more than four million from the fourth quarter of twenty four. As a reminder, our base business excludes any revenue for high volume clean cap for commercialized vaccines, which we have not included in the forecast for twenty twenty five. Our nucleic acid production, or NAP segment, had revenue of $29 million in Q1, an increase of $1 million from the $28 million of base NAP revenue in Q4 2024. The biologic safety testing segment, or BST revenue, was $18 million in the first quarter, up $3 million over Q4 2024, and flat to Q1 2024. Q1 was the strongest quarter for our BST business last year. Revenues by customer type in Q1 were 29% biopharma, 28% life science and diagnostics, 6% academia, 7% CDMO, and 30% through distributor. Revenue by geography was 62% North America, 15% EMEA, 15% Asia Pacific, and 8% in China. Please move to slide six, and we'll discuss the potential impact of tariffs and trade to Marabai. This issue continues to be a very dynamic situation, as it is within our industry and the broader global economy. A reminder here that our manufacturing footprint for Trilink, Cygnus, and AlphaZyme is 100% U.S. based. From a cost of goods standpoint, the vast majority of our supply chain is also U.S. based, and our team is currently working to investigate Tier 2 and Tier 3 supply inputs to assess potential risks and mitigate wherever possible. I'd like to point out that our strategy of having an integrated vertical ecosystem for genomic medicines in our NAP segment has prepared us for this potentiality. Through the acquisitions we've made over the last several years, beginning with MyChem, which is U.S.-based chemistry inputs and R&D, continuing with AlphaZyme, which is US-based enzyme production in R&D, and most recently with Molecular Assemblies, which is US-based DNA production and a technology platform. We have pursued a vertical integration strategy for reasons of quality differentiation, speed, and total product cost. Due to the critical participation TriLink played in the pandemic response, out of that necessity, we had also begun supply chain security work during the pandemic. From an input cost perspective, we have therefore been in process to minimize imported inputs for the last several years. For those items which still come from other countries, we've been actively validating alternate suppliers and working with vendors. To date, we have not seen any material impact from tariffs on inputs, but we continue to work on the situation daily. On the export side, our BST business has the majority of our China exposure with $3.8 million, or 21% of the reported $18 million in BST revenue from Q1 coming from China. Based on the work we've done to date, we believe we've mitigated our first half impact from China tariffs, and we're working closely with our distribution partners to further mitigate potential impacts in the second half. Kevin will go into more detail on our Q1 results and our mitigation efforts for potential tariffs later in the call. We remain keenly focused on our return to growth strategy and building a diversified, predictable franchise as a life science tool provider and clinical partner. To enable long-term sustainable growth for our business, we continue to place prudent, educated bets and expand our product and services portfolios. We expect to further advance our market leadership in genomic medicines and drive the introduction of scientific innovation in ways that support and accelerate our customers' program to build long-term value across Marwai. To the point on our portfolio expansion and business diversification, let's turn to slide 7 for some updates in our nucleic acid production segment. In our TriLink Discovery product portfolio, we're very excited to launch a new technology to enhance mRNA performance, our PolyA Plus line. mRNA, through its natural design, is a linear molecule, meaning that it has a beginning, a front end, and a back end. The information that sits between those bookends is the genetic code that is specific to the protein the mRNA will express in the natural process called translation. Recent research and clinical development have demonstrated the importance of various modifications through chemical or enzymatic methods across the entire mRNA sequence from cap to tail and everything in between, which can result in translational activity being enhanced while reducing innate immunogenicity risks. TriLink's CleanCap technology was developed to be the gold standard for the cap or to protect and enhance the front end of the mRNA molecule. Intuitively protecting both ends of the molecule is critical from the perspective of extending the stability and longevity of the mRNA. With that in mind, Trilink has developed a proprietary toolkit of poly-A tail modifications to protect and enhance the back end of the molecule, which in early data have shown in vitro and in vivo to both increase protein expression and extend duration of expression of the mRNA molecule in certain circumstances. We believe that simultaneously optimizing both the cap and the tail, or the beginning and the end, will enhance the potency of the molecule to expand the potential use of mRNA in the next generation of genomic medicines. We demonstrate the impact of this enhancement on slide eight, where a picture speaks a thousand words. Here you can visually appreciate the extension of expression pattern of a fluorescent reporter gene in mice who have been injected with the mRNA with and without the new tail modification. The combination of the M6 cap with the modified tail results in an extension of the standard kinetic expression profile. The inclusion of these modifications into an mRNA product could potentially expand its clinical application and the therapeutic window is being considered. This new technology, which is patent-pending, is now available as a service offering from Trilink, and we will be presenting it at an industry conference in San Diego next week. Turning to slide 9 for some further NAP innovation highlights, I'm pleased to announce that our TriLink discovery unit now offers high fidelity HPLC purified guides for CRISPR. TriLink offers custom individualized discovery guide RNAs designed to advance CRISPR-based cell and gene therapies through high purity processes, expanded modifications, and links up to 160 bases. With over two decades of DNA and RNA manufacturing experience, our guide RNA synthesis services are customizable featuring process development and consulted support from our oligo experts. Our guide RNAs, which have improved impurity and expanded modification capabilities, are preferred by CRISPR cell and gene therapy customers for preclinical projects and are often ordered in combination with high-fidelity mRNA, also from TriLink Discovery. We've enhanced our oligo business with the recent acquisition of Molecular Assembly's assets, which closed in Q1. We have completed the chemistry tech transfer and are already producing oligos over 200 bases. This technology is well suited to moving to 400 bases and beyond, which can enable and enhance several applications. The integration is ahead of schedule, and we're very pleased with the high purity results from our early synthesis runs. Not only does this expand our oligo product portfolio, as planned, we are on track to vertically integrate this process by using our own chemistries enzymes, and proprietary technologies as inputs to provide significant cost of goods benefit that we can pass on to our customers. These long-ago inputs will also be used to create DNA templates for our mRNA production. We have officially launched our process development services. This is something we've done informally for our customers on a project-to-project basis and have built on that successful foundation to offer a formal service to all customers. With the acquisition of vCNAbio, we now offer adaptive machine learning DOE optimization strategies for faster and more efficient identification of optimal reaction conditions. Our process development services include bespoke mRNA sequence and manufacturing optimization, including codon optimization and UTR tuning to boost in vivo expression, design of experiment studies to meet manufacturing targets, and scale-up support for our clinical customers. This will help our customers confidently move from product inception through clinical development, all while leveraging our full suite of tailored analytical services. And we believe these services can bring real value to our customers. We continue to leverage the synergies between TriLink and AlphaZyme by launching additional IBT enzymes to improve the mRNA workflow and provide additional cost benefits through vertical integration. During the first quarter, we had 30 trialing customers also order IVT enzymes through our cross-selling efforts. Our innovation engine is strong in both NAP and BST. More on BST in a few slides. We intend to launch many additional products as we move forward, and we are engaging more deeply with customers as we support their research programs with custom constructs. We also continue to bolster our market leadership in the mRNA and genomic medicine space through strategic partnerships and CleanCap license and supply agreements. We have signed five additional license and supply agreements for CleanCap year-to-date, bringing our total to 48. Our licensees represent global customers spanning the spectrum from large pharma to innovative biotech and a mix of clinical, commercial, academic, CDMO enablement and nucleic acid manufacturing platforms. Additionally, we're proud of our 18 current academic innovation partnerships and collaborations to allow us to maintain cutting edge science and research. By fostering these relationships, we are able to provide foundational support to universities, enhancing our synergistic research, while additionally assisting these entities to navigate current funding challenges. We believe that investing in new products and services and partnering with leading industry and academic partners is a key driver for creating long-term value. We are in an exceptional position to win customers early for product and technology adoption and grow with them as their programs advance through the clinic. Let's turn to slide 10 for an update on the pipeline for preclinical and clinical programs. Following our Q4 call, we received positive feedback from many of you regarding the business intelligence tool we have developed to track mRNA and guide RNA pipeline progression. You may recall that we identified approximately 1,500 discovery and development stage candidates currently in the pipelines we track, and that through the end of 2024, 477 of those programs were in the clinic. Today we're showing updated insights from the pipeline database in response to some follow-up questions we received last quarter, particularly around the program attrition and exit velocity. The data continues to show sustained investment and interest in early-stage research. In Q1 alone, 95 new preclinical programs were added and 14 programs advanced into clinical development. Ninety-one preclinical programs were discontinued or became inactive during the quarter. While attrition is a natural part of the process, the overall trend across discovery and clinical remains positive. We continue to see estimated net growth in the development pipeline, with CleanCap customers representing over 35 percent of these programs. Although not all preclinical drug assets are publicly disclosed and captured in our data, for the programs that are covered in our data more than 25% advance into the clinic. Let's turn to slide 11 in our biologic safety testing business updates under the Cygnus Technologies brand. As with the nucleic acid segment, we continue to innovate to bring improved products and services to market that support our customers. In collaboration with the TriLink team, Cygnus expanded the AccuRES host cell DNA quantification portfolio with two additional kits. We now have analytics in this portfolio for CHO, E. coli, and all human cell lines. All kits in the AccuRES portfolio contain TriLink's CleanAm technology, building on the collaboration between our two brands. A new kit was also added to the Mach-V product line, the RVLP inactivation kit. Like the original Mach-V RVLP kit, it lets researchers include viral clearance testing early in the development and optimization of their manufacturing processes. By integrating viral analytical studies early, companies can streamline development timelines and move more confidently into clinical and commercial manufacturing. We also recently developed process-specific host cell protein analytics for one of the world's top three biologic CDMOs, supporting their two premium CHO cell line-based development and manufacturing activities. Many biopharma companies rely on this CDMO for their clinical program development. Similar to our approach in the NAP segment, we expect to continually enhance our BST offerings to provide exceptional technical support, services, and a comprehensive catalog of products to meet our customers' needs. Cygnus consistently supports and advances technologies to enhance safety and help accelerate the progress of new therapeutic monoclonal antibodies, biosimilars, cell and gene therapies, through the development and regulatory approval process. We're very proud that Cygnus kits continue to have a 100% participation rate and support the safety testing of all 24 of the 24 FDA or EMA approved CAR T cell and gene therapies. Before I turn the call over to Kevin, I'd like to mention that later this week we'll be publishing our 2024 sustainability report. Without question, our commitment to sustainability goes hand-in-hand with achieving our company's long-term strategic objectives. On slide 12, you'll find a preview of the report. This new report covers the 2024 calendar year and provides an expansive look into our evolving sustainability program with tangible examples of how we're making a positive impact in positioning our business for sustainable growth. Along with the safety and quality of our products, We take pride in our sustainability advancements. We are working diligently to enhance transparency for our customers and investors and to build the infrastructure necessary to return to growth in a socially and environmentally responsible manner. This team has accomplished significant work today, and we are committed to being responsible corporate citizens. We look forward to keeping you informed about our journey. Moving to slide 13, I'll now ask Kevin to provide more details on our first quarter performance and our expectations for the balance of the year. Kevin?