Hello everyone. I'm Deb Hart, Head of Investor Relations. On behalf of Maravai LifeSciences, I welcome you to our first ever Investor R&D Day. Thank you all for joining us. Let me start off with some housekeeping. Our R&D Day presentation and other supporting materials will be available in the Investor Relations section of our website under events and presentations. A replay of the webcast will be available after the conclusion of the event. Turning to the next slide, we may make forward-looking statements during this event, including those regarding our business goals, product launches, and expectations for the financial performance of the company. These statements are subject to risks and uncertainties that may cause actual events or results to differ. I encourage you to view our various filings with the SEC for a description of our risk factors. Additionally, today's comments reflect our current view, which could change as a result of new information, future events, or other factors, and the company does not obligate or commit itself to update these forward-looking statements except as required by law. During this event, we will be using non-GAAP measurements of certain of our historic results. Reconciliations of GAAP to non-GAAP financial measures can be found on our website and at the end of our slide deck. These adjusted financial measures should not be viewed as an alternative to GAAP measures, but are intended to better enable investors to benchmark our current results against historic performance and the performance of our peers. Turning to slide four in our agenda. We're excited about the opportunity for you to hear from leaders from across Maravai who will be sharing information about our markets and opportunities, some scientific and technical developments being made in our divisions, investments we're making in infrastructure, and other ways we are deploying our balance sheet, including some detail on our announcement this morning of our acquisition of MyChem. Additionally, we're pleased to welcome two key opinion leaders, Dr. Mike Mitchell and Dr. Mohamad-Gabriel Alame, both from the University of Pennsylvania, for an engaging panel discussion on cell and gene therapies. As a reminder, our Q4 earnings date is scheduled for February 23, and that's when we'll discuss financial results for 2021 and our 2022 guidance, and we do not intend to do so here today. Again, welcome. Thank you for joining us. I'm pleased to introduce Carl Hull, our Chief Executive Officer, who will kick things off today. Carl? Well, thank you, Deb, and I'd like to add my personal welcome to all of our attendees today. We certainly appreciate your taking the time to join us. It's a very exciting day for us here at Maravai. Not only are we very pleased to be able to share with you quite a bit more about our science and technology, but we also announced this morning our first acquisition as a public company. The founders of MyChem and the members of their team here in San Diego are joining TriLink to extend our capabilities in the manufacturing of critical raw materials that are used in cell and gene therapy, molecular diagnostics, and mRNA vaccine manufacturing. You'll be hearing a bit more about MyChem later in today's presentation. The assignment I have been given is to set the stage for what is to follow by telling you a bit more about the markets that we operate in and the commercial opportunities that we are pursuing. Let me begin on the next slide, please. The numbers that you see here reflect only our performance through the third quarter of 2021, but they do give you something of a feel for the super exciting trajectory that our business remains on. Our TTM revenues of $669 million grew at 202%, while our Adjusted EBITDA grew 308% during that same time period. This explosive growth has been managed by a team of over 500 people across our two business segments, Biologics Safety Testing and Nucleic Acid Production. Our customers include the world's leading biopharma companies who are making massive strategic investments in the fields of RNA therapeutics and mRNA vaccines. We are pleased to be a trusted supplier of components, nucleic acids, and biologics assays to all of these folks. Our particular expertise in making messenger RNA has combined with the exploding demand for outsourced and novel nucleic acids to create a seemingly endless series of new commercial opportunities for us. Could I have the next slide? Historians will look back at this period as something of a golden age for the life sciences industry. It comes as a result of a confluence of factors, each one of which would have represented quite a significant industry tailwind on its own. Years of government and private investment have created an ever-expanding base of scientific understanding of human biology. In particular, that understanding has been driven by the many advances in genetic sequencing, along with the development of analytical tools that allow scientists to examine what is occurring at the cellular level in real time. We've also seen the rapid development of new therapeutic modalities, such as mRNA, that allow scientists and clinicians to do things that were not even remotely possible five or ten years ago. These developments and the occasional pandemic have accelerated product development timelines across the board. Regulators and governments have dramatically changed their philosophies about how to manage risks versus rewards. As a result, investors of all stripes have funded innovation in life sciences at an unprecedented rate and continue to do so. Next slide. As a direct and indirect beneficiary of some of that investment, we have built Maravai to provide solutions across the entire continuum of life sciences, from early discovery to the full commercialization of healthcare products. I mentioned our two businesses earlier, Nucleic Acid Production and Biologics Safety Testing. Each offers multiple products and services at different points across the continuum, as you can see here. Next slide. This slightly more granular view shows you which of our operating companies, TriLink BioTechnologies, Glen Research, Cygnus Technologies, and now MyChem, offer what kinds of products and services across the various end markets that are our areas of strategic focus. These end markets include messenger RNA vaccines, cell and gene therapies, biologics and biosimilars, and molecular diagnostic. Taken together, could I have the next slide, please, these market segments have us competing in a large addressable market of $4.7 billion projected to grow at a very attractive 7% rate for each of the next three years. By contrast, this compares quite well with the broadest view of the entire life sciences industry seen in light blue here, which is about 3 x the size of our addressable market. Next slide. The novel therapeutic modalities that our customers are developing are going through an amazing growth spurt themselves. The number of programs that are in the mRNA pipeline today have way more than doubled in the past two years, while gene and cell therapies under development have increased by 44% and 71% respectively. The major application of these technologies are found in infectious disease vaccines, hematology and oncology therapeutics, which include immuno-oncology vaccines, and in a slew of rare genetic diseases, many of which have no therapeutic alternatives available today. Moving to the next slide. It turns out that warp speed is indeed a very good way to describe the world of messenger RNA during the last couple of years. This month marked exactly two years since the SARS-CoV-2 virus was first sequenced. Since then, multiple vaccines and therapeutics for COVID have been discovered, developed, and marketed. It's now such that the WHO estimates 9.6 billion doses of vaccine have been administered as of last week. Truly remarkable. That's not where the story ends. If I could have the next slide. That's actually where it begins. Messenger RNA applications and the science behind them have grown at breakneck speed now that their clinical potential is more fully appreciated. Albert Bourla from Pfizer said that it felt like the science behind mRNA had progressed 10 years during the past two years. We would agree with that. In the mRNA vaccines field, there are now four flu vaccines in clinical trials. There are 50 non-flu vaccines in the clinic and another 84 pre-clinical vaccine programs that have been disclosed. In the mRNA therapeutics field, we believe that there are 16 drugs in the clinic today and another 63 pre-clinical programs that have been disclosed. This totals to 217 mRNA-based drug development programs out there today. This robust view of messenger RNA drug development pipeline is supported by other industry participants who have been quoted recently as saying that there may now be 200 different mRNA programs at some stage of development. As you can see, mRNA should clearly not be considered a one-trick pony entirely dependent on COVID vaccines alone, as some have suggested, nor is it a technology platform that has itself plateaued and is now facing some sort of terminal cliff in the near future. Instead, the entire field has a substantial opportunity ahead. First, to complete the critically important work of vaccinating the remaining billions of people in the world who have not yet received a single dose of vaccine. As an aside, it is truly sobering to realize that about one-fifth of the world's countries have only been able to vaccinate less than 10% of their citizens. The second massive opportunity that we see is in those pipeline numbers on this slide. These are largely early-stage programs where the TriLink outsource development model works particularly well as companies spool up their own capabilities, in some cases from scratch. In addition to those hundreds of programs, we fully expect that much of the funding for mRNA that has, at least up until recently, been focused on COVID will ultimately be redirected to a number of new therapeutic applications for nucleic acids. What is also very important to understand is that these therapies will ultimately require much more mRNA per patient than even repeated doses of a COVID vaccine. As you'll see at the bottom left-hand column here, individual dosings of mRNA for therapeutic purposes may require 100-500 x more messenger RNA than a vaccine uses today. These drugs may need to be administered multiple times during a patient's life. Could we have the next slide? We are also directly involved in the more broadly defined cell and gene therapy market outside of the mRNA world. This comes from both our Biologics Safety Testing business at Cygnus and our Nucleic Acid Production operations. Our host cell protein assays are not only the market leaders when it comes to producing biologics, such as monoclonal antibodies, but we are also an active participant in multiple gene therapy programs where host cell protein assays are used during the manufacturing of viral vectors and plasmid DNA. Further, we participate in a number of gene editing programs by providing RNA guide strands or messenger RNA that encodes for gene editing enzymes such as Cas9. One of the most exciting and rapidly growing applications for a number of our products is base editing, where technology now exists to allow for the permanent repair of single nucleotide mutations that cause diseases as diverse as sickle cell anemia, progeria, or even high cholesterol. Hundreds of companies now have direct gene editing drugs or genetically modified cell therapies such as CAR-T therapies under development, and those therapeutic product markets are projected to exceed $30 billion in sales as soon as 2024. Next slide, please. While immensely exciting science and technology are at work here, there are a number of challenges the biopharma world faces as we strive to industrialize the development and commercial manufacturing of these novel drugs. You can see some of those listed here. To further validate numerous comments that have been made elsewhere about the complexity and fragmented nature of the supply chain for novel therapeutics, consider the example provided by Pfizer concerning its own COVID-19 vaccine requirements. There are over 280 separate components used in making this one vaccine from 86 different suppliers operating in 19 different countries. We see opportunity in that complexity for Maravai to offer more of these cutting-edge components to all of our existing customers. Next slide, please. We are pursuing these opportunities by expanding our product offerings and capabilities as we are doing today with MyChem, by making larger focused investments in R&D across the company, by continuing to invest in our own capacity and in our people, and by innovating with our customers. Next slide. It goes without saying that Maravai is in a unique position to do this right now, thanks to our superior growth and profitability along with the resulting cash flows. On the organic front, we are employing novel technologies to improve and scale our manufacturing processes, and we are adding tightly controlled GMP manufacturing capabilities and new facilities. On the inorganic side, as you can see through the MyChem acquisition, we are committed to expanding our reach in this entirely new industrial supply chain, and we are actively looking to expand our international footprint so that we may directly serve our growing global customer base. Next slide. What I hope you will see in the presentations that follow is first, that Maravai is uniquely well positioned in some of the most exciting target markets that exist in life sciences today, and there's a clear opportunity for us to be a long-term player as a supplier of complex and differentiated solutions to the biopharma industry, and finally, that we are building this business for long-term sustainable growth. Could I have the final slide, please? It's now my pleasure to introduce you to Doreen Pippen, Maravai's Vice President of Marketing, who will be moderating our KOL panel discussion on cell and gene therapies. Doreen? Thank you, Carl. The power of mRNA has been realized through the COVID-19 vaccine in our fight against the pandemic. Today, we are grateful to have two leading mRNA enthusiasts from the University of Pennsylvania, Dr. Mike Mitchell and Dr. Mohamad-Gabriel Alameh. Join us to share their insights on the impact of mRNA in non-COVID-19 applications, particularly in the exciting field of cell and gene therapy. Gentlemen, welcome. We're going to start with you, Dr. Alameh. Your research is focused on the design of nanomaterials for vaccine development. How pivotal do you think mRNA will become in the future of non-COVID vaccines and why? I do believe that mRNA has a great potential beyond vaccination. Applications such as, for example, genome editing and CAR T cells are crucial, and mRNA would be able to to deliver on the promise because of the half-life of the mRNA, for example. In certain application where you want to edit a gene, but you don't want the protein to stay in the cells for a very long time, mRNA would be an ideal molecule in order to create that peak of protein expression and elimination. That's one of the reason why mRNA will be basically a workhorse in those type of applications. Yes, that's exciting. Dr. Mitchell, your work focuses on the interface of biomaterial science, drug delivery, and cellular and molecular bioengineering, and this can be applied to a range of human health areas, including cancer metastasis, immunotherapy, genome editing as Dr. Alameh had highlighted, and regenerative medicine. Why is mRNA essential to your research? Yeah, I would say, you know, why mRNA is essential to our research is we're trying to develop new types of drug carriers for nucleic acid therapy. You know, as Dr. Alameh was just mentioning, you know, we have certain applications right now for mRNA therapeutics that are hitting the clinic quite rapidly with vaccines, and we're also seeing more and more gene editing work. One of the things we're most excited about in the mRNA space is extrahepatic delivery and going beyond vaccines as well. To really do that, you need drug delivery systems with novel tropism properties to target cells and tissues in the body in a very specific manner. That's what our lab really works on, drug delivery technologies, and mRNA is essential for that because if we can develop a new delivery system that could bring nucleic acids to muscle or brain or stem cells, we could then use mRNA. Once we get it to the site of interest, we could use it for any sort of protein replacement application, gene editing or, you know, vaccines or anything like that. Yeah, that's exciting. We've seen enormous interest and investment in cell and gene therapy, from new companies being formed to increasing R&D budgets. Dr. Alameh, why is that? That's mainly, in my opinion, and I guess Dr. Mitchell will agree, it's mainly because of the success that COVID-19 vaccines, you know, have had in the past, and also because the mRNA as a molecule, the production of the molecule is easy, straightforward. It's quick also. Once we reach our certain capabilities to manufacture it in large scale, and we have these manufacturing sites all over the world, it becomes very commoditized. It becomes very quick. From the design of the protein to the production of the vial would be very, very quick and cheap as well. That's one of the reasons, I guess. The other reason is the versatility, actually, of the molecule. You basically can encode any type of protein with whatever you want as a protein with an mRNA. The bottleneck, as Mike mentioned, is really delivering it to tissues that are of interest. That's great. Dr. Mitchell, anything to add in terms of the influx of interest and why that might be? I think, you know, one of the things I'll add, you know, Dr. Alameh said it beautifully, but, you know, one of the great things that we've seen, you know, and that investors have clearly seen is these nanoparticles and mRNAs have now been injected into over 1 billion patients, right? So I mean, if you're thinking about an important safety marker for a technology, what better than having, you know, data behind, you know, billions of patients being dosed with these therapeutics or vaccines? So, you know, from a company perspective, from a VC perspective, they see this incredible safety in this new and emerging technology. It becomes easier for them to see how this could expand into different areas. Of course, there's gonna be challenges when you move from a vaccine to something that goes into your bloodstream. There are additional challenges with facing the immune system, and there's gonna be requirements of new technologies to deliver it, but you can see that next step in terms of replacing potentially current pharmaceutical drugs with mRNA therapeutics, particularly in the protein replacement space. Rather than developing a recombinant protein, it could be much easier to develop an mRNA and then have a cell of interest secrete that protein. Yeah, that's so exciting. What, why is it so important now? What's happened to really make this acceleration possible? I know you both mentioned COVID-19, and that's really the onset, but is there anything else that's really making this so important now in the cell and gene therapy space? In my opinion, actually, one of the basically most important element that enabled all this is the nucleoside modifications of the mRNA. Without the nucleoside modifications, mRNA was very immunogenic and created a lot of side effects, right? Especially for, you know, application beyond vaccines, we need the mRNA molecule to be immune silent and not trigger any immune effect, you know, once delivered. That's one side of the story. The other side is the development of lipid-based system that actually was being validated with small interfering RNA in the clinic, and those delivery systems played a crucial role also in translating the technology. Both the nucleoside modification and the lipid played a very important role in my opinion. That's fantastic. Dr. Mitchell, anything else that's helping with this acceleration? You know, I'll add to that in basically saying this was in the making, you know, before COVID. You know, right before COVID happened, we had significant advancements in this field. If we think about Alnylam Pharmaceuticals, they had their lipid nanoparticle siRNA drug Onpattro approved. We had great companies such as Moderna and BioNTech already had clinical trials in the mRNA space ongoing for vaccines and cancer immunotherapy. At the same time, we had the CRISPR revolution occurring, so the ability to gene edit different cell and tissue types and using mRNA to do that, mRNA coding for Cas9. We had a lot of pieces that were already being developed. There was a lot of interest already building in this field before COVID. I think what COVID did was just accelerate that process by, you know, maybe five years. That's great. I'd add, as Mike mentioned actually, that people's enthusiasm is very important, right? That's that excitement that they had throughout, you know, the last 10 years or the last decade, that's what's pushing and continuing to push now the effort to these novel medicines. Yeah. That's an important part, the passion there. Are there particular cell and gene therapy areas that you do find promising? Let's start with you, Dr. Alameh. I do believe in CAR-T, in vivo CAR-T, for example, and genome editing. Also targeting hematopoietic stem cells, for example, would be a very important and promising approach to treat virtually any disease, and combining actually these application together is very powerful actually for the future of therapies. Yeah. Yeah. Thank you. Dr. Mitchell? Yeah, I'll add onto that, you know, our lab's really a nanomedicine and drug delivery lab, you know, before lipid nanoparticles, before mRNA, you know, when people were thinking about treating things such as cancer, they were developing nanoparticle drugs with the idea that they have to get into tumors and reach every cell type of interest. But what's been exciting about immunotherapy is we don't need to do that potentially. We can hit immune cells that are much more accessible in the bloodstream with nanoparticles to treat disease, and we think that this is a broadly enabling concept going forward with lipid nanoparticles and mRNAs. Dr. Alameh said developing CAR-T cells in the body could be of interest. This could be applied to potentially autoimmune disorders as well as targeting hematopoietic stem cells and blood and bone marrow for targeting. There's a lot of great work being done in this space showing that this is possible, that we can reach these immune cell types. Given that the immune system plays a role in so many different diseases, cancer, neurological disorders, muscle diseases, the ability to develop these nanoparticle mRNA therapeutics further just to target immune cells in general can be applied to various disease applications, even beyond cancer. Yeah. Yeah. Makes good sense. Dr. Mitchell, in your opinion, how and you've touched on this a little, but how critical is mRNA in enabling these successful outcome with cell and gene therapy? How pivotal will that, you know, the mRNA modality be? Yeah. I think that's a very good question, and I think it depends, you know, what you compare it against. You know, we work very closely with clinicians here at Penn too who work on viral therapies. These viral therapies can be used for protein replacement therapies, so cells can re-secrete proteins. They could be used for gene editing as well. These have had some success in the clinic, but they've also had some challenges with translating these therapeutic technologies. In that space, you know, mRNA is really exciting because you have the RNA transiently expressed in the cell. There's no genomic integration or anything like that. It only needs to reach the cytosol to then ultimately trigger protein expression. We can think about that for, you know, some of the traditional viral-based methods for protein secretion, we can now do it with an RNA that's safer, but we can also apply that to CRISPR-Cas9 as well. We think about, you know, viral-based methods. A challenge with gene editing using viruses is you could have the gene editing material essentially hanging out or swimming in a cell for too long, and there could be off-target effects. With RNA, you could get temporal expression of gene editing cargo, get the cell to do its job, and then eventually, you know, it that degrades over time, and you no longer have it present in the cell. Its transient expression is definitely a huge value for a variety of therapeutic applications. That's great. Dr. Alameh, anything to add? I basically totally agree with Mike, and one of the things that maybe it's not interesting to the mRNA molecule itself, but to the delivery system with lipid or polymeric, it's easier actually to do a repeated administration compared to viral vectors, for example, where one can develop an immune response against the viral vector itself and then neutralize it upon a second infection. So both these, the carrier and the mRNA play a very important role for the success of this technology. Yes. Yes. Definitely. What I'll add too is that these delivery technologies with mRNA therapeutics, the speed at which you can make these is incredible. If you're developing a protein replacement or, you know, gene editing therapy using a virus, it can take a lot of time, cost, and labor to develop these. You know, Momo is a close collaborator of ours at Penn. We work closely in the LNP and mRNA space. We'll have our labs working together and, you know, within a matter of a week, Momo will have new RNAs designed, and then we can evaluate those therapies quite rapidly. As you can see, Momo's a big fan. I'm a big fan. The collaborations and the speed at which we move is incredible. Yeah. That's fantastic. I know it's been very exciting to see how fast things have moved. What are the critical capabilities that are needed for mRNA to be a successful modality in cell and gene therapy? Can you expand a little bit on some of the things that you've shared? Mike, you can start if you want. The question is, what are some of the things for mRNA to be a successful modality? Correct. What are the critical capabilities that need to be in place? You've talked about the delivery systems as being something that really has catapulted for the research. Are there any other critical capabilities that you feel are really important in order for mRNA to be really successful in the clinic for cell and gene therapy? Yeah, I think that's an excellent question. One thing I'll comment on in this space is the temporal nature of mRNA could be a huge advantage, but it could also be something that we want to improve upon as well. For certain protein replacement therapies, you know, we could deliver mRNA, we could secrete therapeutic proteins. I think one thing that we might need going further for certain applications is longer term expression of therapeutic proteins. If we think about something like a virus, or think about something like plasmid DNA, we could get longer secretion of a therapeutic protein. With mRNA right now, I think there's going to be technologies to do this, is typically the expression that we get, and Momo could detail it further, but it's typically shorter than what we would get with a virus or DNA. There's a lot of exciting technologies in the works in this space right now to increase the duration of therapeutic protein expression using mRNA. I think that's going to be a focus area moving forward. Great. Great. I do believe, and I agree with Mike, that extending actually the expression levels of expression level and durability of the mRNA is an area of focus. I also would believe that expertise is key here. Whether it's expertise in designing the molecule itself, you know, the protein that you want to deliver, and also how to translate this protein into an mRNA that is effectively expressed for a long period of time is critical. I do also believe from our experience here at Penn that production and from things that we've seen with different manufacturers, that production of mRNA is not as easy as people believe. It is as a process very straightforward, but there is very small technical details that people need to understand and control in order to have high quality RNA. This expertise in my opinion is kind of lacking to date, I mean. Great. It sounds like we have some more to do there, but I know in the area of expertise, we've come a long way in the last- Yeah ... 10 years, definitely. Are there any advancements on the horizon in cell and gene therapy that excite you both? I know there's a lot of enthusiasm I'm hearing already, but anything else coming on the horizon that the community would be interested to hear more about? Dr. Alameh, let's start with you. I mean, in the short future, I would see, as Mike mentioned as well, a CAR-T, in vivo CAR-T being the next big thing. Also therapies for example, using gene therapies and genome editing in order to excise for example, viral genome that are integrated into cells like HIV would be something really big. Targeting the nanoparticle to subsets of cells is a very important area where people now are putting a lot of effort, including our lab and Mike's lab, and we've seen actually data where we can, for example, transfect or deliver mRNA LNPs into a specific cell types, or for example CD4+, or CD8s, and then we can either genetically manipulate these cells to, for example, excise a genome or to deliver, like a chimeric antigen receptor, and these cells are able to go and do their job in vivo. I think in the near future, these kind of therapies are going to be the next big thing, I would assume. That's great. Dr. Mitchell? Yeah. I think the big three things that, you know, we think about are, you know, as Momo was saying, is tropism and delivery of RNA cargos using delivery systems. You know, we have great delivery systems right now for the liver and for vaccines. The question is how do we hit other cells and tissues in the body while also avoiding accumulation in the liver. The liver acts almost like a sponge for lipid nanoparticles. If we can de-target away from the liver and enrich for different cell and tissue types, it's gonna give rise to a lot of different applications. Somewhat related to that is once we develop the systems to deliver RNA to those different cell and tissue types, as I was mentioning before, improving therapeutic secretion of these proteins using RNAs, messenger RNA is going to be very important. This could be in the form of messenger RNA. This could be in the form of replicon mRNAs as well. This could be in the form of what's emerging now in the field of circular RNAs. There are new companies forming that improve the therapeutic secretion of proteins using a circular RNA construct. I think over the next couple of years, in addition, very much related to mRNA, new RNA technologies that are either RNA based or very similar to RNA are going to emerge, and I think as we have new technologies for delivery and new RNA cargos, we're going to have to figure out how do we manufacture these at a very large scale. As Momo was mentioning, you know, making the RNA is very challenging and, you know, making the lipids very challenging. But perhaps what is most challenging is when they all come together and formulate nanoparticles, and how do we do that at a very large scale? We also collaborate, you know, with Momo on this, developing new microfluidic devices that could enable scale up. As more and more companies emerge and they have to develop facilities to develop these LNPs, they're going to need the technologies to do that. There's a lot of room to innovate in this space as well. That's fantastic. Thank you both so much, Dr. Alameh and Dr. Mitchell. I feel like we could have probably spent another 30, 40 minutes or more learning about this exciting field of, you know, mRNA in cell and gene therapy. Thank you for sharing your time, your expertise, your perspective with us today, your insights on the positive impact that mRNA is having currently, your enthusiasm about the possibilities moving forward is inspiring. Really appreciate your time. Thank you. Thank you so much. Thank you. While this discussion focused on mRNA for cell and gene therapy and non-COVID vaccines, both of these rapidly evolving and growing application areas are key growth drivers for our biologics safety testing portfolio. Next, Christine Dolan, the Chief Operating Officer for Cygnus Technologies, and her team will share more about this exciting innovations in this area of our business. To talk about Cygnus Technologies. Moving to the first slide, please. Biologics Safety Testing is an integral part of the protein-based drug, gene therapy, and vaccine development continuum. The safety market is typically broken down by the types of testing performed: endotoxin, sterility, and pyrogen testing, process-related impurity testing, and viral clearance testing. Cygnus Technologies is the leader and innovator in the latter two segments. Host cell proteins, or HCPs, represent the most complex group of process-related impurities, a biological drug produced using cell culture technologies. Even at extremely low levels, HCPs can be immunogenic or interfere with the drug efficacy or stability. Thus, regulatory agencies require that biopharmaceutical manufacturers use broadly reactive HCP immunoassays to track HCP removal and ensure process consistency and final drug substance purity. Cygnus' core competency is development of broadly reactive HCP antibodies in qualified ELISA. Regulators also require that developers use orthogonal methods to prove that the immunoassay and the antibody on which this assay is based are a good fit for a given process. Cygnus leads the industry with state-of-the-art orthogonal testing services such as AAE, antibody affinity extraction for coverage, and mass spec for identification. Other process-related impurities include purification resin leachates, growth media additives, and bioprocessing enzymes. Likewise, these impurities are required to be reduced to the lowest practical levels. Cygnus provides the most comprehensive portfolio of process-related impurity immunoassay kits for our global biopharmaceutical manufacturers. Finally, regulatory agencies require proof of viral clearance before clinical and commercial approval. Our viral clearance prediction, MockV product line, is the newest IP protected addition to the Cygnus product portfolio. MockV revolutionizes viral clearance studies and helps de-risk downstream purification early in the process development. Let's move to slide two and note that Cygnus operates in a niche submarket that has experienced sustained long-term growth as the biopharmaceutical product industry continues to innovate and bring effective products to market. As Cygnus has established itself as the gold standard for host cell protein and other bioprocess impurity detection, our portfolio of products is selected and used by the global industry very early on in the drug development cycle and at high volume as manufacturers develop and qualify their processes. As this is the case, Cygnus' growth has outpaced the market and is expected to continue to do so. We have grown an average of 20% year-over-year for the past decade. The availability of our generic or off-the-shelf kit products, coupled with our best-in-class technical support and orthogonal and custom services, make us the provider of choice throughout the product life cycle. If we move to the next slide. We have delivered this growth on the strength and depth of our portfolio. Ken Hoffman, the Founder of Cygnus, invested early on in visionary R&D programs, developing immunoassays and orthogonal analytics for every expression platform available during the 2000s. At this time, CHO, our Chinese hamster ovary, and E. coli platforms were widely used for therapeutic protein and monoclonal antibody programs. Cygnus leveraged the success of these platforms as a benchmark to develop immunoassays not only for host cell protein detection for all the expression platforms, but also to address the process impurities presented as part of the downstream purification process. As a result, Cygnus has the most extensive portfolio on the globe. As these assays take a minimum of three years to develop and deploy, this visionary early investment strategy paid off. ELISA assay for HEK 293, for example, was developed in 2005 and did not have much industry application for 10 years. However, with the recent focus on gene and cell therapy, this platform has grown over 500% and is now our number two product. Cygnus has the only reliable commercial product on the market to support these programs. We also support 10 out of 10 of the recent FDA-approved CAR T gene therapy programs. Finally, on the next slide, you can see that Cygnus provides support from development through commercialization. We are continuously innovating to add to our portfolio, refine and improve the existing products, as well as adding the viral prediction MockV portfolio, which brings a similar innovative and disruptive technology to the viral clearance testing market as Cygnus did 2.5 decades ago to the host cell protein market. While we enjoy the regulatory stickiness of our products, we do not take it for granted. We understand that we must continue to invest and innovate to ensure the safety of these important drug products and anticipate the needs of the market. Next, Eric Bishop, Vice President of R&D, will talk about recent and future innovations in the HCP space, followed by David Cetlin, Senior Director, who will speak about the progress we have made in the development of the MockV product line. Thank you, and over to you, Eric. Thank you, Christine. It's a pleasure to be here this morning, and I'm really excited to share some of the new things going on at Cygnus Technologies. Cygnus has a complete offering of all common expression platforms currently used for production of therapeutic proteins and in cell gene therapy. We also continually explore the market for new expression platforms and innovations in purification strategies. This allows us to stay ahead of the market needs and release new products that can support new expression platforms and technologies as soon as they're ready for commercial launch. We are currently working on PG13 host cell protein ELISA. PG13 is a retrovirus packaging cell line derived from the NIH 3T3, which is of mouse origin. These cells produce high quality, high titer viral vectors for cell and gene therapy. C1 is an upcoming fungal expression platform used for the production of biologics and vaccines. We're currently working on a new Protein A ligand with a partnership with JSR, and we are partnered with two companies that are working on affinity ligands for the purification of AAV. Along with this, we continually support 25-30 custom assays for our customers. Next slide, please. Cygnus maintains a commanding lead in orthogonal services. We pioneered the antibody affinity extraction for performing coverage analysis in 2013, and we have changed how the industry has evaluated if a host cell protein ELISA was fit for purpose. We have now expanded that advantage by coupling the antibody affinity extraction to mass spectrometry. This allows our clients to know exactly what host cell proteins are present in their samples and which ones the antibody reacts to. In addition to the identification of the individual host cell proteins, we know the isoelectric point and the molecular weight of the individual proteins. Using this information, we can also prepare virtual images that are color-coded to spot trends in protein reactivity in addition to providing the coverage of the antibodies to the host cell protein population. Next slide, please. This slide, I believe, will eventually, if not currently, change the entire industry. As an industry, we have always known that mass spec would be a great tool in understanding host cell proteins. However, the bar graph on the left demonstrates why mass spec has had limited success in HCP analytics. As you can see, the product related proteins on the left are in such high abundance that the detector is swamped and very few host cell proteins are detected. The image on the right is our visibility when incorporating antibody affinity extraction as a sample preparation tool in mass spec. As you can see, the product related peptides have greatly been depleted and the host cell proteins have been enriched. This means that for the very first time, we truly have the ability to know what host cell proteins are persisting through the purification process and into the final drug substance. This knowledge will allow us to perform accurate risk assessments on identified host cell proteins, enable decisions about which host cell proteins have the ability to cause negative effects with respect to patient safety or product stability. Next slide, please. Regulatory agencies require a sponsor to demonstrate that a host cell protein ELISA that's going to be used for process monitoring and release testing is appropriate for use. This includes coverage analysis to demonstrate that the assay is reactive to the majority of the host cell proteins in an upstream sample. Our superior service offerings make it possible for a client to know that the host cell protein ELISA that they have selected is appropriate for use. This data is then included into the regulatory filings and method SOPs. At that point, our host cell protein ELISA is used to release that product for its entire life cycle. Next slide, please. Finally, our complete offerings from generic and custom kits to orthogonal services makes us an extension of our clients' critical reagent capabilities. Cygnus is here to provide generic kits for testing early in a project. As a project moves through the stages of clinical development, we can assist them in understanding if they can continue to use the generic host cell protein ELISA or if a custom ELISA is needed. If a custom host cell protein ELISA is required, Cygnus can produce that assay and offer assistance required to transition between the generic kit and the custom host cell protein ELISA. This service is extremely valuable to our clients as generation and maintenance of host cell protein ELISAs and the associated components require a very high level of expertise not generally found in many biopharmaceutical companies. With that, I would like to introduce David Cetlin. He's the Senior Director of R&D, and he will discuss the MockV product line at Cygnus Technologies. Thank you very much, Eric. Happy to be here. Next slide, please. We've all just heard, Cygnus is the world leader in biopharmaceutical impurity detection, offering the industry's most diverse range of products from host cell proteins, host cell DNA, process-related leachables, and other impurities such as endotoxins. These kits provide invaluable data that enable scientists to develop, optimize, validate, and manufacture their pipeline of therapeutics. However, until recently, one particular process-related impurity has been unaddressed from a kitting perspective, that is virus. Next slide, please. Virus can arise during biopharmaceutical manufacture through exogenous contamination events or through the use of endogenous raw materials such as cell lines. Indeed, viral contamination events have occurred, and as a result, regulatory agencies around the world have established guidelines on how to demonstrate the effective removal of virus from a biopharmaceutical manufacturing process. Proof of effective clearance is required before clinical trials can commence, and again prior to commercial approval. So-called spiking studies are the means by which this proof is established. These studies require live mammalian viruses, specialized facilities, and involve a panel of mammalian viruses. Next slide, please. Due to the use of live infectious mammalian virus, spiking studies are performed off-site at contract research organizations. These CROs are equipped with highly trained personnel and biosafety level two or three containment systems. As a result of the required specialization and complex logistics, IND and BLA enabling studies can range from $100,000-$500,000. These costs present a major hurdle during process development as the scientists rely on readily available data from impurity kits as they develop and optimize their manufacturing process steps. Typically, during these years, viral clearance is left out of the equation and is first addressed during regulatory enabling validation studies, a bad time to learn if viral clearance effectiveness is not up to par. Next slide, please. To address the issues with this current paradigm, Cygnus Technologies has introduced a new technology platform, the MockV kit product line. MockV kits provide non-infectious viral surrogates that mimic the physical chemical properties of live viruses used by CROs. These BSL-1 compatible particles enable scientists to conduct their own predictive viral clearance studies on their own bench at a fraction of the cost and time. Each kit contains the analytical components necessary to carry out roughly 10 small-scale experiments, and different kits are being developed to model the different viruses used for validation studies. The image to the right depicts our first commercial kits, the MockV MVM Kits, which contains a mock parvovirus particle, which is used internationally as a cornerstone for demonstrating viral clearance. The table below highlights the unique value proposition offered by our kits. Next slide, please. We will now watch a short video clip highlighting our customer's perspective of the MockV approach. My name is Michael Winkler. I work at REGENXBIO in Rockville, Maryland. I lead the downstream process development team here, and we're one of the leaders in AAV gene therapy. My name is David Kahn. I'm Vice President of Biopharmaceutical Development at MacroGenics. Our focus is on developing therapies that we hope to be effective in treating multiple different types of cancers, both solid tumors and blood-borne cancers. Viral clearance studies are an important part of the regulatory expectation from the FDA or regulatory agencies in other countries. It's a requirement to prove as part of the safety of your drug that you don't have any endogenous virus or unwanted virus in your product. Viral clearance comes with a host of challenges. One of the challenges is that you need to find a contract research organization that you can work with that has the appropriate facilities and know-how to handle these viruses. The key limitation in exploring viral clearance in our downstream process is that if you're doing it with a live virus, you won't be able to execute that in our laboratory. If you're doing it at a contract research organization, you're gonna be limited by the expense. You typically don't have good insight into your process's capability until you actually do the studies. Mock V is a new product on the market that can really help alleviate some of these challenges. It mimics MVM, a small non-enveloped virus. It has all the physicochemical properties, but it's not an infectious virus. You can bring this Mock V particle into your lab and do some initial screening studies to get an idea of what the capability of your process would be. With Mock V, you have a cost-effective way to screen your process and get some indication of the viral clearance capability earlier in the development life cycle. Mock V sort of lands in that sweet spot of affordability and safety where we can answer these questions in our own laboratory. It's another advantage of Mock V is its ease of use. You don't have to be an expert in PCR. You don't have to be an expert in handling live virus. Again, some of the challenges that are faced in viral clearance studies, you literally are looking for changes in the level of infectivity to get a titer of the virus particles, and that's very complex. Typically in downstream labs, you won't find that expertise. It enables us to execute the studies, but then get the results on our own, which is very enabling. Thinking about the future of viral clearance, it's something that's been around a long time and I anticipate will remain. It's a key component of proving that your product is safe. The MockV particles potentially provide a way to reduce the overall burden for companies that have multiple products on sort of a platform approach. I think as an industry, we're at a very interesting time with regards to viral clearance. I think the combination of a breadth of really now multiple decades of viral clearance studies, but also a demonstration that we understand our operating space that these steps are being run in. This gets us to a place where maybe we don't have to keep doing these studies and investing resource and taking the time to replicate something we really already are highly confident we know the answer to. The Mock V pipeline is expected to grow over the course of 2022 and beyond. As previously mentioned, the Mock V MVM kit is currently on the market. We expect to release a second generation version of this kit in Q2, which will allow for greater analytical sensitivity. Also in Q2, we expect the release of our highly anticipated RVLP kit containing a non-infectious retrovirus-like particle, which may in time replace the need for live retrovirus validation spiking studies. Beyond 2022, additional kits will be developed and commercialized to meet our customers' needs. Last slide, please. Mock V will be a solid contributor to the Biologics Safety Testing revenues in the near and long term. We address the unmet need in the biopharmaceutical process development industry. Our underlying technology built upon the use of non-infectious viral surrogates is patent protected in the U.S. and globally, and we have a rich pipeline of kits under development. Now I'd like to introduce Brian Neel, the Chief Operating Officer of Nucleic Acid Production at TriLink. Thank you, David. Appreciate the introduction, and thanks to everyone who's taken the time to join us today. Next slide, please. Look, I'm really looking forward to getting the chance to talk to everybody about the developments at TriLink as we take a deeper dive into the rapidly evolving future of mRNA technology. First, as I like to typically do, I'd like to take a moment to reflect a little bit before I dive deeper with a little bit of a backstory. It was around mid-2018 when TriLink made the decision to further accelerate into the mRNA space as a strategic focus area. We made sizable investments in product innovation, services, and infrastructure in order to improve customer outcomes to the clinic and beyond. This really was a turning point in our story as we were starting to see the amazing progress in the mRNA programs we were making towards the clinic and several of our early adopters of CleanCap technology. We knew we needed to scale up with them, provide the quality material needed for the clinical and commercial use, and build the facilities needed to be able to produce therapeutic-grade mRNA, CleanCap, and other critical raw materials. Our state-of-the-art mRNA facility we sit in today in San Diego opened in November 2019, just months before the COVID-19 pandemic. Around March 2020, we were starting to get an early and very telling glimpse of the promise of mRNA vaccines as a key way to fight in the global pandemic. It was at this point we immediately started to design space for additional capacity in San Diego to scale up CleanCap. That was what this facility was ultimately designed for. Fast forward to today, TriLink has emerged over the last two years as critical leaders in the space, providers of the CleanCap technology, which was included in the first ever commercial mRNA vaccine with Pfizer and BioNTech. As Carl mentioned before, that really is just the beginning of the story. It's one incredible example of the power of mRNA. Today, I would like to talk about the broad range of products and outsourced development services we are focused on along with CleanCap. I'm proud of the fact that in our pipeline, over 500 mRNA service customers, the vast majority utilize CleanCap today. Each one of these mRNA service customers represents the potential for a new therapeutic or vaccine coming to the market. At TriLink, we're uniquely positioned as leaders in chemically produced raw materials as well as biological products, services, including our plasmid and mRNA IVT services. We're continuing to aggressively innovate and expand across the spectrum, and I'll cover that more today. Next slide, please. Over the last six years, customers have typically come to us to help advance their mRNA API development programs into the clinic. It is at this point where they make decisions on their targets, sequence, modifications, manufacturing, regulatory strategy, and ultimately what I like to call their platform decision. Our goal has always been to help develop this platform strategy, which will ultimately become difficult to change following phase I clinical without major program modifications. We believe CleanCap and its one-pot transcription process and potential for modifications has emerged as a leading platform choice for mRNA capping. The vast majority of our 500 mRNA customers utilize CleanCap technology, and I'd like to expand on that journey a bit. This early work around platform development, selection, and target scaling into the clinic starts in our Wateridge facility. We have invested over $75 million over the last few years to develop the capabilities for screening, scale-up, and engineering to producing clinical grade API. We're typically scaling the range of 1 gram to tens of grams of mRNA at this point. We do have the capability to go much higher in scale at our Wateridge facility, and we'll continue to invest in scaling to stay ahead of the customer base. For later phase clinical work and commercial raw materials, including CleanCap, we are in the middle of design and construction of our new Flanders facility in San Diego. It is here that we plan to progress customer programs toward later clinical phases and continue to scale up their targets of interest as they prepare for commercialization. Next slide, please. I wanted to share an overview of the overall discovery to GMP funnels that sits today with the company. Most of our customers are somewhere between discovery to early GMP clinical work. There's been an absolute explosion of interest in mRNA over the last few years. In fact, our mRNA discovery customers have nearly doubled in the last year alone. It is at this discovery phase where we drive the adoption of CleanCap as best-in-class platform option. Over 85% of our customers are using CleanCap from discovery and into the GMP phase. Once in the GMP phase, our customers begin to make greater investment on target scaling and preparation for tox in phase I studies, where we often see what we'll call a lock-in of CleanCap into programs. Within the mRNA services funnel, we segment in three key areas. Each area continues to grow year-over-year. Our first segment, which is on the left, is the mRNA discovery, where we have over 500 customers ordering mRNA with CleanCap. It's at this stage where customers typically are screening and identifying targets of interest in order to develop their platform. The materials we manufacture at this point are typically research grade. The customer is narrowing their candidates and selection at this point. Our next segment, which is in the middle, is comprised of our GMP mRNA customers. Today, 50 of our mRNA service customers are actively at this phase utilizing CleanCap mRNA. It is at this point where scale-up, engineering, and tox studies and clinical builds are being performed. We'll often cross over into the gram scale manufacturing at this point, and the customers start to commit to CleanCap in their platform. Of these 50 customers on the right, 15 of them make up our last segment. These are the customers that have actively entered the clinic with CleanCap mRNA. This is an exciting point in any program, and we're now planning to be able to progress with our customers into phase II for the future. I also want to point out that we have several hundred customers that also purchase CleanCap as a reagent as well, and this slide is really just meant to focus on the service customers today, not the reagent customers. The majority of our GMP customers, at about 60%, are working on non-COVID-related vaccines and therapeutics. We currently have several GMP customers who have focused the platform development on COVID-19 due to the global need and often have other target aspirations. This platform development could aid in developing new targets for them in the future. For me, this chart really shows the incredible presence of CleanCap in the global drug development funnel and represents an amazing opportunity to bring new therapeutics to market. TriLink plays a key role in providing CleanCap mRNA services to these customers, and we see a bright future ahead. Next slide, please. In order to understand a typical customer journey from discovery to the clinic, I wanted to highlight a blinded customer program that has been ongoing and active for about the last 18 months and where we provide services. This program is from a customer's oncology program working on cell therapy technology, which includes CleanCap as part of the mRNA platform. The customer initially came to us with around 200 targets with a plan to work on target selection over several steps. At each step, they narrowed the set of targets, and we increased the quality, quantity, and scale of the mRNA production. During the initial phase, they were in the 10- to 80-mg scale range and selected down to 45 targets. Following this phase, they entered engineering phase with five targets and moved to the gram scale, followed by tox studies and GMP production at an 8-gram scale for clinical studies. I think this progression really highlights our ability to deliver high scale and high quality levels across programs where needed. This is a typical journey and one we could expect to see for the 500+ customers in our active funnel as they have success along their discovery phase and platform development. This is where TriLink excels, and we are investing not only in improving screening, scale, quality, and turnaround time, but also in progressing with our customers in the later phase scale-up development and manufacturing at our future Flanders facility. Next slide, please. Now I'd like to take you through a quick overview of the customer journey in our Wateridge facility in San Diego. We're proud of the capabilities and design of this facility, and it has been instrumental in creating the capacity needed to bring customers through the discovery and early clinical phases of development. Before I start, I also want to note that it's also within this facility that we started 24/7 operations during the pandemic, along with three emergency construction projects with cooperation from the great city of San Diego in order to deliver GMP-grade CleanCap for the Pfizer BioNTech COVID-19 vaccine. We have continuously delivered high quality material without a single delay in shipment. I'm so proud of the efforts of the team at TriLink as this work continues. The timing of the facility could not have been more perfect, and the efforts by our teams in working with Pfizer and BioNTech truly transformed our company. Now I'd like to share the video representing a customer's journey. TriLink BioTechnologies, a division of Maravai, is a global leader in RNA synthesis and scale-up, including mRNA production, yield enhancing proprietary CleanCap mRNA capping technology, and CDMO services ranging from research to GMP grades. We work closely with our customers throughout their journey from discovery to commercialization, and our capabilities scale with our customers throughout development. During the discovery process, customers consult with our team to discuss conducting research use only screening studies to identify the optimal construct for their application. They may screen several products, varying sequences, and modified nucleotides at small scales. These products are manufactured in our RUO manufacturing lab using benchtop equipment such as thermal cyclers, water baths, and centrifuges. After the discovery process, customers may choose to move on to process development to optimize for highest yield and quality. They also speak with our business development team regarding their path to GMP. Benchtop equipment is used in this early development work, and feasibility runs begin to utilize mid-scale equipment. We hold regular status meetings with our customers to keep them informed of their development and manufacturing progress. Following successful testing of the feasibility material by the customer, we design and execute engineering batches to meet their desired GMP scale requirements. Engineering lots can make use of TriLink manufactured plasmid, which is generated in a dedicated ISO 8 clean room manufacturing facility. Once the engineering builds are completed, batch records and product specific specifications are finalized, and our customer moves to GMP manufacturing. GMP manufacturing is completed in one of our ISO 8 clean room suites with a highly trained and GMP dedicated team. Following completion of manufacturing and quality control assays, the product is released by our quality assurance team. We provide the customer with executed and reviewed batch records along with a campaign summary report. With our state-of-the-art facilities, we're working with our customers to provide the next generation of therapies, diagnostics, and novel vaccines. San Diego, it is the people that truly make a difference at TriLink as we continue to innovate and lead in this space. Now, as I mentioned, we are also designing and constructing two additional state-of-the-art buildings in San Diego with a focus on the production of GMP raw materials for commercial use and later phase mRNA manufacturing. These sites will enable seamless progression for our customer base. Our Flanders 1 facility will be dedicated commercial site for CleanCap and other nucleic acid raw materials for use in vaccines and therapeutics. This site will give us redundant chemistry capabilities as well as space design for larger scale processes. Our Flanders 2 facility will be dedicated to manufacturing mRNA for later phase to early commercial applications. This building will provide seamless transition for our growing clinical customer base as they progress to later phases of clinical to commercial development. Next slide, please. With the additional capabilities and capacity we're bringing online, we'll also be investing in innovation in both our products and services. I wanted to share a roadmap for the introduction of additional offerings we plan to bring to market over the next three years. We really have three main objectives here. One is to enable seamless transition of mRNA programs from discovery to clinical to commercial phases. This includes further investment in our plasmid capabilities to streamline programs. Two, we plan to further innovate our product portfolio with next generation CleanCap products and to expand GMP raw material offerings including CleanCap analogs and modified NTPs. Our focus will be on chemical synthesis of these products. Third, we want to improve the CleanCap mRNA transcription process with our new CleanScript technology to improve yields, quality, and protein production. I'd like to note that Mike Houston, our CSO, will walk through these products and services later. We earn a unique opportunity to drive CleanCap inclusion across our growing mRNA customer base while providing critical GMP raw materials and technology to improve the IVT reaction. These programs will continue to bring value to our customers and help improve the quality of mRNA for years to come. I believe the combination of the innovative products along with our people and added facilities will allow us to continue to grow and lead the way as pioneers in mRNA technology and services. Next slide, please. Well, the last area I wanted to cover today is around the exciting announcement this morning of our acquisition of MyChem in San Diego. MyChem was founded by Chanfeng Zhao and Tao Jiang and has developed a strong expertise in nucleic acid chemistry. Chanfeng and Tao, along with their team, have been able to achieve amazing results in rapidly developing, optimizing, and scaling nucleic acid products. They have been a go-to for years as their customers have had challenging products to develop and needed innovative chemistry development to meet their technology needs. I truly see them as partners with the development teams they serve within their customer base. MyChem specializes in ultra-pure chemically synthesized nucleotides and has been a critical supplier of key raw materials for several TriLink products over the last few years, and I'm pleased that this acquisition will strengthen our supply chain for chemistry products. I'm also looking forward to continuing to work with the team at MyChem to accelerate the discovery and development of critical nucleic acid products for our therapeutic development programs. Their ability to address broad life science markets, including diagnostics and therapeutics, will provide a nice synergy with both of our customer bases as a combined company. I'm quite excited about the addition of MyChem to the Maravai family and believe this will allow us to accelerate new products to the market. I truly look forward to this next exciting chapter, and I wanna thank you all for your time today. With that concludes my remarks, and at this point I'll turn it back over to Deb for our first Q&A session. Thanks, Brian. This is our first of two Q&A sessions for the day. All of the presenters that you heard from this morning are available for your questions, with the exception of our expert panelists. For the analysts in our Zoom room, if you would like to ask a question, please raise your hand by clicking the Raise Hand button under the reactions at the bottom of your Zoom window. Before asking your question, we ask you to please unmute your audio and be sure that your video is on. For the other participants on our web stream, you can enter your questions in the question box on the right side of your screen. Rebecca, let's take our first question from the sell-side analysts. Our first question comes from Tejas Savant from Morgan Stanley. Tejas, can you please unmute your audio and video and ask your question? Hey, guys. Thanks for all the content today. Carl, one for you maybe just to kick things off. The broadening of the demand beyond sort of the COVID vaccines for mRNA was clearly an important sort of point of emphasis in the presentation today. As you think about that 100x- 500x more material per dose and potentially multiple doses per indication, one of the things that, you know, we've been grappling with is to what degree does that sort of provide an offset for you in terms of patient numbers being generally a lot smaller for some of these indications? As these pipelines have matured here a little bit over the last, you know, six months or so, can you share your updated thoughts on that, please? Oh, sure, Tejas, I'd be happy to do so. Look, I think that the move into other vaccines and therapeutics broadly is one that's just accelerating daily and I can't even really do it justice to describe what Brian and his team are dealing with right now. What we see happening is that the volumes obviously continue to grow in the COVID world, and that's as expected, and we can always talk about, you know, the future of vaccination strategies. When we think about the therapeutics, you're now looking at more and more indications. As we began our journey in mRNA land, a decade or two ago, we were really working with customers who were only focused on exceptionally rare genetic diseases because that's all that you could do in those days or that people thought you could do. Now with the advancements that you heard about from our panelists and the delivery systems and the deeper understanding of the biology, what we're finding is that our customers are targeting diseases that are much more widespread and larger patient populations. While you may say progeria is a relatively extremely rare disease, when you think about something like hypercholesterolemia, it has a huge broad indication. We think we're just scratching the surface here, and you're seeing the tip of that iceberg that's out there. Quite honestly, at those kind of volumes, there will be lots and lots of mRNA being made and lots and lots of CleanCap being consumed. Got it. That's helpful. Then, congrats on the MyChem news this morning. Thank you. Couple of quick questions there. Can you maybe share some insight on, first of all, the competitive differentiation for their process versus standard enzymatic approaches, what the competitive landscape looks like? I have a quick follow-up. Well, sure. I think if you look at the approach taken by MyChem's founders to producing ultrapure material that cannot be equaled enzymatically, that's the major differentiation, right? It's really analogous to what we do with CleanCap. CleanCap being a chemical capping method versus the preexisting enzymatic methods, Qianfeng and her team are doing exactly the same thing, just applying it to nucleotide production. We see the fit, the philosophy, and the science actually being quite similar, and we think they're well-differentiated because nobody else can do what they do, and we know that as a customer. Got it. What fraction of MyChem's revenue was essentially, you know, coming from Maravai? Just trying to get a sense of the degree to which you have customer overlap, you know, with them already for the non-Maravai portion of their revenue, and how do you see that sort of expanding over the next couple of years over here? Yeah. Tejas, we're not gonna get into the numbers today just because we wanted this focus to be on the science and technology. We'll have more to say on the acquisition and what the expectations should be at the earnings call. Got it. Fair enough. Just one final one for me here. In terms of just you know the rest of the portfolio as you look about you know potential you know M&A opportunities perhaps on the Biologics Safety Testing side or other low-hanging fruit even on the Nucleic Acid Production side following MyChem what are your thoughts there Carl? We're gonna be as active as we always have been. I think you saw us take a little bit of a pause when there was a distraction around the IPO, but I think we're back on focus now, and you should expect to see more of similar types of deals in the future. I would point out this is very much exactly like the other deals that we did with wonderful scientifically driven companies led by their founders, and it's a model that we're exceptionally familiar with and comfortable with. Got it. Thank you, guys. Thank you, Tejas. Thanks for the question, Tejas. Rebecca, can we go to the next question from an analyst? Our next question comes from Matthew Sykes from Goldman Sachs. Matthew, please unmute yourself and ask your question. Great. Thanks very much for taking my questions, and really appreciate the presentation today. It's been very helpful. Maybe my first question for Christine and Eric on biologics safety. I know that during the IPO you talked about the competitive advantage of the generic test kit having I think it was over 21 assays relative to the competition, which was sort of anywhere from one to three, that allowed your customers to cast a really wide net, and by the time they kind of narrowed it down, they were very familiar with your product, and you got, you know, kind of more shots on goal to get specced in. Can you talk about that competitive environment and the other types of generic test kits that are out there? Have they expanded their generic test kits to better match yours, or do you still have that competitive advantage, in that particular case? Christine? Sure, yeah. I'll start this, and I'll kick it over to Eric. Yes, we still maintain the competitive advantage in this space. As we said during the time of the IPO, you know, we have 28 host cell protein kits with 23 expression cell lines. We're adding two more, as Eric identified earlier in his presentation. And our competitive landscape looks like this. I mean, we have a couple of competitors that have one or two kits in the host cell protein space, and then maybe one or two in the bioprocess space. We are, like we said before, the gold standard in terms of the depth of our portfolio, and we're not gonna stop in terms of adding to it as we see fit. Anything to add there, Eric? I think I would only add that, you know, because of our longevity in the industry, we've gained the trust of the largest biopharmaceutical companies in the world as well as regulatory agencies around the world. Cygnus truly has become the go-to company for host cell protein analytics, and just for that, it's really helped us keep a competitive advantage. Got it. Thank you for that. Carl, maybe just one for you on MyChem. I know you're not gonna go through numbers, but just more a high-level strategic standpoint, kind of along the lines of what Tejas was asking. You know, part of the acquisition seems to be to better integrate the supply chain that you have. But there also seems to be a number of cross-selling opportunities with those non-Maravai customers that you spoke about. I'm just wondering, as you think about the opportunity of MyChem maybe 1- 3- 5 years later, do you feel like the benefits early on will be from the integration of the supply chain and then future revenue opportunities from the cross-selling opportunities, and could that future opportunity dwarf what you see on the integration side? I guess to simplify it, is this sort of a early defensive acquisition and a later offensive acquisition? Is that how we should think about it, or is that not the right way to characterize it? Well, I don't wanna call any acquisition an offensive acquisition, but I get your point. No, I think it's very insightful, Matt, and the right way to think about it. We clearly like the supply chain integration, as a first point. The second is that we feel that the science that is behind Chanfeng and her team is outstanding, and we know it from a first-hand experience. We also reflect on our previous acquisitions of similar companies, and you may recall around the time of the IPO, we told you that our previous deals, the businesses were all nice. They were growing sort of 8% on average at the time that we did the acquisitions. Shortly after the acquisitions, we were able to increase that growth rate of revenues by over 20% up to 20%. I think that shows you that not only is there a long-term potential benefit, as you suggest, there's probably gonna be some pretty quick low-hanging fruit that we're gonna be able to access. I am bullish about that cross-selling impact even from day one. Great. Thanks. I'll leave it there and let others jump in. Thanks so much. Thank you very much. Thanks, Matt. Rebecca, let's take one from the web platform. Carl, this has to do with our organic investments. Someone is asking for an update on our plasmid DNA offering. Sure. The plasmid DNA offering is active, and maybe I'll turn to Brian and ask him to comment a little bit on what we're seeing there. Yeah. I mean, I think we're at an exciting point right now, and as you saw on the NPI funnel, we're planning to launch a 3-liter scale. We've already launched 6-liter scale here at the Wateridge site. It really is forward-thinking at that point. We're getting to those larger scales, thinking about the Flanders building and crossing over to that space. What we're seeing now is what we thought we'd see, is when we can get into programs early and catch them in the early part of development as they enter into the GMP funnel, it's actually the perfect place to catch these customers. We're seeing a nice uptick in statements of work getting signed right now with new GMP customers coming to the funnel. I'd say, you know, it's gonna be a good progress for us this year. We have plans to bring some additional expertise as well to help, you know, our multi-year plan here to get this up and running at a larger scale as well. Great. Thanks, Brian. Rebecca, let's go to the south side room again for the next question. Our next question comes from Catherine Schulte from Baird. Catherine, please unmute your audio and video and ask your question. All right. Thanks everybody for hosting today. Maybe one for Carl or Brian. You know, what kind of role do you see self-amplifying RNAs playing in the future, either in next generation vaccines or as we get into treatments where we need, you know, higher levels of mRNA per dose? You know, how should we view the trade-offs between some of the delivery challenges of those versus the advantages of, you know, having, being able to get higher protein expression for lower doses? Yeah, I think it's a great question, Catherine. Look, self-amplifying RNAs are being developed apace. They're every bit as much a focus as traditional mRNAs are among our customers. The reports that we get back, which obviously are somewhat limited, have identified challenges that you alluded to associated with saRNAs, and not the least of which is the size of the combined sequence and replicase that you're talking about, and then how do you deliver that thing reliably. I think it's a little bit more technically challenging for our customers, but we know that they are looking at it for those specific indications. The difference for us is simply the amount of mRNA that is utilized. Obviously with the self-replicating mRNA, it's gonna be a lesser amount of initial starting material that is used to deliver that greater amount of protein. But right now I think we're playing in both areas, and we'll see which one, you know, survives or thrives the best. Okay. Got it. Appreciated the color on the GMP CleanCap customers, but maybe from a program perspective, is there a way to frame of those, I think it was 217 mRNA programs that you laid out, you know, what portion of those are using CleanCap? It is tough, and we have a project underway right now to do exactly that, but it's gonna require some outside help to survey the universe. That number of 217 programs in fact changed two days before this presentation, so it is a very dynamic area, and you have to be very careful to make sure that you're assessing it. We don't know. What I would say is if you were trying to infer from Brian's slide, well, you've got 15 programs in your mRNA services out of 217, that's not an apples to apples comparison because, as Brian pointed out, we sell a lot of just plain CleanCap to customers who themselves then are making the mRNA and may well be in the clinic. That one won't give you a good proxy. Yeah. Okay. Got it. Last one for me, for David on the MockV team. You know, do you have a sense for what kind of failure rates are out there in industry for viral clearance tests? Just trying to get a sense for, you know, how big of a pain point this is in industry. Sure, sure. Just so I'm clear about your question, are you asking how many contamination events occur at large scale, or how often does a company develop a process, and then during validation does it not achieve the effective clearance for a BLA application? Right, more the latter. They send that to the Yeah CRO for that test Yeah They come up with a failure. No, gotcha. That's a great question. The truth is we don't know except for anecdotally, because those, that data does not have to be reported. When there's a failure for a validation study, there's an interest that that company actually does not wanna let that out because that could tip off a regulator to look with more scrutiny into that validation study. I can only say from my own experience, I've spent about eight years at Human Genome Sciences and GlaxoSmithKline before MockV. I did about a dozen viral clearance tests. It happened maybe 10% of the time, but when it does, it's a bad scenario. We spent three years developing and optimizing process, and in a matter of months you have to retool that whole entire process just to hit a viral clearance target. It's something that everyone knows can happen, and even the infrequency of that, it's still bad enough that with an economic tool like MockV, we think that will, kind of, you know, tip the scales, and it'll be widely adopted because of that value proposition. All right, great. Thanks everyone. Good. Catherine, thanks for the question. Rebecca, let's go to another question. Our next question comes from Michael Ryskin from BofA Securities. Michael, please unmute yourself and ask your question. Hey, thanks. Can you guys hear me? Yes. Great. Hey, Carl. I'll try to be quick. A couple follow-ups that are kind of gonna get at the same point. One is you called out some of the new mRNA vaccines you're working on or you're seeing in the market require 100x-500x bigger dose than COVID mRNA. I'm just wondering if you could go into a little bit more detail in terms of what's driving that, and does that necessarily translate to 100x-500 x more revenue to Maravai per dose? Sort of how does that translate, the dosage amount versus what you're seeing in your economics? Sure. I may have not been clear on that, Mike, about the source of that increased demand. That's actually from the mRNA therapeutics, not from other mRNA vaccines. Got it. Right now what we see is mRNA vaccines tend to hover in the same range that's been established, which is sort of 25-100 micrograms per dose. When you compare it to a therapeutic dose that would be administered to a patient for these other applications, that's 100x-500 x. Gotcha. I appreciate that. I must have missed that. Yeah. Sorry about that. No, it's all right. Then when you're talking about the customer journey, I think you had a great slide, I think it was slide 42, you were talking about, you know, you showed that great ramp of how the micrograms and the grams that the customer uses increases. You move from, you know, pre-clinical to late development into the clinicals. I'm just wondering how much variability is there customer to customer to customer? Anything you can say in terms of, again, is the revenue per stage similar for you? It's a different way of asking. You know, we're trying to all model when you're gonna see this gradual increase in revenues as the non-COVID projects mature, right? As demonstrated, there's obviously going to be a massive step-up as you get into those later phases. Anything you can tell us in terms of the variability there, sort of, what the revenues are and where the exposure is. Then also the customers you have that are non-COVID now that are in the clinic, the 15 you highlighted from the service GMP business or in the others, are they approaching phase I, phase II, phase III? Give us a sense of when that algorithmic step-up is gonna happen. Sure. I think Brian's probably in the best position to tell you how typical that progress is and, you know, where these other customers are. Brian? Yeah, I mean, I think typically, you know, the example I showed was about 18 months. We typically say, you know, 12-24 months is kind of how these programs evolve to get to a phase I position. That's assuming a lot of things, that they've got a platform that's, you know, gonna be able to move forward. I think that seems 18 months is kind of a typical range from, hey, a customer comes in from a discovery perspective, they've got a good candidate or a set of candidates, and they want to progress a few of those to a phase I clinical. 18 months is a good indicator, I think, an average. You know, in terms of the actual scale, you know, I think that the way I like to look at that too is in discovery, we're typically in the milligram range of scale, so it's a bench scale, it's more high throughput. As you're starting to select targets, you start scaling to where we are now. You get ready for the clinical study, you're in the gram scale, and we have a lot of customers that are desiring to go to reactors for that and column purification. You know, we could see definitely, you know, kind of a 1 gram minimum up to, you know, tens of grams to get into phase I clinical, and that's typically what we're seeing right now. As we have programs go beyond that, we'll have more to share in the future, but right now most of our customers are in that kind of preparation for phase I. That's really helpful. Much appreciated. I'll get back in queue. Thanks. All right. Well, thanks for all the great questions. Apologies to anyone we didn't get a chance to get to yet. We will have another Q&A session in a bit. For now we're gonna take a 10-minute break, and after which time Mike Houston, our Chief Scientific Officer from TriLink, will present. See you soon. Welcome back everyone. Hope you had a nice little break. I'm very pleased to introduce Mike Houston, our Chief Scientific Officer for TriLink, who's gonna do a deep dive into CleanCap and CleanScript. Mike? Thanks, Deb. I'm excited to update everyone on new developments relating to our CleanCap technology and NTPs, and I'll do that in the first section of this presentation, as well as the progress that we've made in improving and scaling our mRNA manufacturing during the second part of the pre-presentation. Before I start, I'd like to give some background information on the screening methodology that we use to evaluate our CleanCap and NTP analogs. First off, we utilize firefly luciferase or fLuc as a reporter system. This is an mRNA. This mRNA is our standard fLuc sequence. The sequence was uridine depleted and modified by N1-methylpseudouridine, which is the modification found in the BioNTech and Pfizer vaccines, as well as the Moderna vaccine as well. All our mRNAs were made in-house and underwent extensive analysis. To reiterate, all the mRNA is exactly the same except for the different cap analogs that we were using. Because we were evaluating these mRNAs in mice, they were formulated into an LNP by our friends at Precision NanoSystems in Vancouver using their GenVoy lipid system. This lipid system shares similarities to mRNA COVID-19 vaccines as well as other mRNA clinical applications as well. Now I'd like to briefly discuss why we chose luciferase as a reporting system using two mRNAs capped by either ARCA or first-generation CleanCap analog CleanCap AG, which is shown on the slide. These two mRNAs were injected into mice via tail vein injection at a dose of 1 mg per kg. The size and characteristics of these LNPs are such that the vast majority of these LNPs go to the liver. Once inside the liver, the FLuc mRNA directs the synthesis of the luciferase protein. Luciferase protein is an enzyme, and in the presence of a substrate induces bioluminescence. This bioluminescence can be captured by a camera system, and images of such are shown above the bar graph here. Intensity of bioluminescence or fluorescence is shown by different colors, blue being low, red being high. The luciferase can be integrated and quantitated numerically, and this is what is represented in the bar graph below. By giving mice the substrate at different time points, one can measure luciferase expression as a function of time, which is what we did in this case from 3 - 96 hours. All right. I know this was a lot, but the take-home message here, more bioluminescence corresponds to more protein. With that in mind, I'd like to discuss the results that we see on this slide. I wanna direct you to the bar graph. If one compares ARCA or anti-reverse cap analog to CleanCap AG, one sees that fluorescence as a function of time is 300% higher for CleanCap AG. This difference highlights one of the advantages of CleanCap, namely the extraordinarily high capping efficiency we and our customers observe, and this is generally greater than 95% or above. For ARCA, this is typically 70%-80%. For a highly functional mRNA, an intact 5' cap is required for efficient translation. Next slide, please. Next, I'd like to look at a comparison between our original CleanCap analog, CleanCap AG, versus a second generation CleanCap analog, which is CleanCap AG (3' OMe). This is the cap analog that's found in the BioNTech and Pfizer COVID-19 vaccine. This analog contains a 3'- O-methyl group, which is highlighted in pink in the structural diagram here on the terminal N7-methyl-G. Following the same study design from the previous slide, what we're observing is an 80%-100% increase in total luciferase activity for CleanCap AG 3'- O-methyl. To reiterate, the only difference between these two cap analogs is the addition of an extra methyl group. This gave us our first hint that there may be a structure-activity relationship around cap analogs that we could use to approach the design and synthesis of novel cap analogs from a more medicinal chemistry approach, and I'll discuss this more on this shortly. Next slide, please. We often get asked to compare CleanCap with enzymatic capping. In the following study, we did a comparison of ARCA, CleanCap AG, CleanCap AG 3'- O-methyl, and enzymatic capping. I'll draw your attention to the last two bars on the right. While CleanCap AG, the green bar, results in slightly higher luciferase levels relative to enzymatic capping, the orange bar, they were not statistically significant. In this study, which has been repeated, the two approaches are equivalent in this model. However, the key advantage of CleanCap is that the mRNA is added co-transcriptionally, meaning that during the transcription reaction, a fully capped mRNA is synthesized. For enzymatic capping, the IVT reaction must be completed first, followed by a second capping reaction to form the fully capped mRNA. Usually, there are additional steps between the IVT reaction and capping step as well. Resulting extra steps are more time-consuming, potentially more expensive. Given the somewhat fragile nature of mRNA, a faster and simplified manufacturing process is preferred. CleanCap offers a much more efficient and direct process with similar lab levels of capping for mRNA manufacturing. Next slide, please. On this slide, we're looking at four different novel CleanCap analogs, which are all structurally distinct from what I presented previously. I'm also presenting data in a little bit of a different situation here, showing luciferase expression at different time points. Interestingly, for all these novel analogs, if we add the same modification to them, this modification substantially increases the levels of luciferase activity. This is similar to the result we saw what between CleanCap AG and CleanCap AG (3' OMe). Subtle changes can have significant effects on luciferase protein expression. This lends further credence to the fact that we believe there is an SAR, structure-activity relationship around capping analogs with respect to protein expression. We believe we can borrow facets of medicinal chemistry to understand the structural requirements of capping with the goal of improving protein expression. This is something that we're actively focusing on at TriLink. Next slide, please. In addition to cap analogs, we have also been working on changes to how and under what conditions we make NTPs, in particular, the key raw material N1-methylpseudouridine. In this particular example, we are evaluating FLuc mRNA made using N1-methylpseudouridine from an existing process which generates a lithium salt to a new cleanroom-made material which generates a sodium salt form. For this new N1-methylpseudouridine offering, we completely revamped the process which has resulted in a highly pure NTP. For these mRNAs, CleanCap AG (3' OMe) served as the cap. On the left-hand side in gray is the luciferase activity resulting from mRNA containing pseudouridine made from the old process. On the right, this represents mRNA made with the new cleanroom grade N1-methylpseudouridine. Somewhat surprisingly, we see a statistically significant increase in luciferase expression of 40%. This is a significant new product introduction for TriLink for a number of reasons. One, the sodium salt is a more appropriate salt for biologics in mRNA. Two, this will be one of the only cleanroom versions of N1-methylpseudouridine on the market, and three, this is a completely synthetic process devoid of enzymes, so customers need not worry about protein-based impurities derived from the enzymatic synthesis falling into their mRNAs. Next slide, please. Now I'd like to switch gears and discuss the progress we've made in improving and scaling mRNA production at TriLink. We have completely revamped our IVT purification and tangential flow or TFF processes. For IVT, we've developed our CleanScript IVT reaction, more on that in the following slide, and instituted a single-use bioreactor platform with temperature control and low shear mixing. On the purification front, we have optimized the purification to increase mRNA quality, remove untailed impurities, as well as protein impurities resulting from the IVT reaction. The purification media is single-use and highly scalable. For TFF, we have identified low shear conditions with high recovery. This is also single-use and scalable platform. While the title says 2 liters, this process is scalable to adjust the needs of our customer requirements from 2 liters and beyond. Next slide, please. Our new CleanScript IVT conditions results in higher yields, which is shown on the right-hand side, and substantially lower double-stranded RNA, which is a key impurity that arises during transcription. We are seeing double the yields on a mg per mL basis. Typical characteristics for the batch are shown below. From a 2-liter IVT reaction, we're typically seeing on the order of up to 18 grams with a final yield of up to 9 grams per liter. We're seeing highly pure material, low double-stranded RNA, and residual protein and residual DNA levels, which are really key impurities, are below the limit of detection. Next slide, please. This particular slide illustrates the purity one can achieve using the new process. HPLC analysis pre- and post-purification, second chromatogram on the left, illustrates the enrichment of full-length material observed during the purification by eliminating untailed material, which is the large black peak that you're seeing in the second chromatogram, as well as truncated species that arise during transcription. Overall purity from this batch was 91.6% pure. Similarly, using an orthogonal electrophoretic method, we see similar full length enrichment and overall purity of around 85%. Next slide, please. Regarding double-stranded RNA, which is a key impurity in mRNA, we synthesized four different mRNAs ranging in size from 1,000 nucleotides to 4,600 nucleotides and compared the levels of double-stranded RNA from our standard or original IVT conditions versus our new CleanScript IVT reaction. What is clear is that we see significant decreases in double-stranded RNA across the board for all four mRNAs. As we continue to use this process for both internal and customer programs, we are seeing this reduction in double-stranded RNA independent of mRNA sequence or size. Furthermore, from a scalability perspective, for FLuc independent of scale, we are seeing a lowering of double-stranded RNA from 3 mL to 2,000 mL or 2 liters. On a final note, we have successfully performed our first GMP manufacturing campaign using this process and look to many more successful campaigns in the future. With that, I'd like to thank you for your time and attention, and I'd now like to introduce Kevin Herde, who is the CFO of Maravai. Great. Thanks, Mike. That's some really compelling data there, and what a great day so far. Hi, everyone. I'm Kevin Herde, CFO of Maravai, and I'm gonna spend a few minutes on our financial position and then discuss how we're investing in Maravai and our opportunities. I realized as we were preparing for this day that much of this is probably very eye-opening to you as we're inherently a company that's so focused on our work, our technology, employees, and our customers, that we don't spend a lot of time on press releases or presentations that don't have solid data or meaningful content. We live it what you've seen here with these great leaders every day, and I truly hope you grasp an increased appreciation of why we invest in this business as aggressively as we do because it's a great business, and it's a personal pleasure to wake up every day and help lead Maravai. Moving to slide 60. Here on slide 60, you'll see our financial performance through the third quarter of 2021. One of the many strengths of Maravai is our EBITDA margin and free cash flows that enable great financial flexibility, allowing us to invest in both organic and inorganic opportunities. Also, as you're getting a sense of throughout this day, our core base business, excluding the spike in COVID pandemic vaccine contributions, is a great business today and has been performing extremely well. In fact, our non-COVID-related business revenues grew 50%, that's 50, for the nine months ending 9/30/2021 and shows no sign of slowing down. Move to slide 61. At the end of the third quarter, we had total cash of $548 million and total debt of $545 million, with trailing 12-month EBITDA of $487 million, creating a net leverage of 0x. Recently, as announced on our press release on January 20, following recent rating agency upgrades and our strong financial performance, we repriced our debt, lowering our effective interest rate by about 125 basis points, which will save us about $7 million in cash interest expense annually with no change in total debt, terms or covenants. On slide 62, as we discussed earlier in the year, we're making meaningful organic expansion investments to support long-term growth. This includes adding a new facility in San Diego called Flanders near our existing Wateridge facility to expand our nucleic acid production capacity and capabilities now up to 183,000 sq ft. This will bring our total nucleic acid production capacity to at least $2 billion in potential revenues. For our Biologics Safety Testing business, we'll be moving from our current Southport facility to a new purpose-built facility in Leland, closer to the Wilmington area. That will double the size of our physical footprint to 45,000 sq ft and further enable expansion of our service offerings, which have been growing tremendously, and support our Mock V program, as David outlined, which has major market potential that we're ready to capitalize on with this new facility. On to slide 63. To go a bit deeper on the expansion of our Nucleic Acid Production footprint, having these two adjacent facilities in San Diego will allow us to have multiple facility redundancy as well as adding the ability to focus teams in the new facility on innovation, oligos, and chemistry. This investment will lay the groundwork towards supporting the strategic initiatives to add capacity and support the strategy that Brian articulated so well and has us so enthusiastic about our future. Now as we can see on slide 64, we continue to invest to ensure we can capitalize on our market opportunities. This timeline shows this formula that has served us extremely well over the years and created tremendous value. Now on slide 65, our state-of-the-art purpose-built facility in Leland will double our square footage when we occupy it later this year and really give us a significant increase in capacity and expand our R&D services and automation, optimizing manufacturing for today's business as well as future volumes. This will also serve as the foundation to deliver on more custom services and our promising Mock V products. On slide 66. Many of you asked what we're going to do with this tremendous cash flow outside of our organic investments. Well, as you saw this morning, we've applied some of that excess cash flow and our strong financial position to buy with cash off our balance sheet, one of our best suppliers and an innovator in high-quality nucleotides that address our growing markets, and that is MyChem. This is a great deal for us. It's another founder-based company with great growth, great reputation, quality customers, and margins for which we believe we can amplify with further investment and integration into our Nucleic Acid Production segment. This is a perfect example of how our balance sheet, along with our strategy of fostering relationships with founder-based companies that we know and trust, can come together to add value. This also demonstrates our continued patience, diligence, and focus on this part of our strategy. We will continue this path of adding assets at the right time, naturally, and through our exhaustive diligence processes, as has been the case since we established Maravai in 2014. This business we acquired is roughly the size of the divested protein detection business, with the $240 million in upfront consideration reflecting around 20x current year EBITDA, but with the growth trajectory of our base non-COVID nucleic acid production business, a segment that it will seamlessly integrate into quickly. We know how to do this, we do it well, and that's exactly what's going to happen here. Now changing gears slightly as we move to slide 67. The focus on our people, our true talent, and the energy and spirit of Maravai has never been more important. We recognize it is a very challenging labor market, but one we continue to be very successful in. One of the main reasons for that success is building our business infrastructure with mindful ESG considerations. We have quickly become recognized as having a well-focused program, particularly for a relatively young public company. Our focus on environmental sustainability, engagement with our employee base, our quality efforts and innovation, along with our commitment and understanding that we must support the communities in which we do business, are reflective of the core foundational values for Maravai. When you look at the experience, reputation, track record of our leadership team and our board, you know this is more than just words on paper. Here we walk the walk. I'll now move to conclude my part of this great day here on slide 68. These core values, plus our foundational attributes reflected in our ESG initiatives, equal a great place to work at Maravai. With all that having been said, let me kick off a video about our culture, after which Carl will take us home with some closing remarks. What gets me really excited about working here is the science part of it. Every day here is something different. Working in the life science industry has definitely been a game changer in my life as far as challenging me to learn something different. I personally have always been interested in human biology, how the body knows what to do, how to heal a wound, how to overcome a cold. As most people were sent home last spring, the research teams really went into overdrive. It is with such passion that we feel like we can say something about what we make. I'm carrying a little bit of my company in my bloodstream, and so does, you know, billions of people in the world. Collaboration here is really critical. It is a team effort. All the departments are like a puzzle piece that have to come together in order for the product to be its best. Being a part of this global change, toward mRNA vaccines, it motivates me. I'm excited to come to work and see the progress we're making. I think the proudest moments I've been here was when we celebrated mRNA Day, just seeing what we started and what it was growing into. Even from then, you know, now with the pandemic, how important RNA is, it just made me really reflect on what this journey has been, and so it's just very exciting to be part of. What really keeps me here is the people that I work for, what we believe in, the support that they give myself and the team. I think it's incredible what we have done, where we're going. Because of that, it helps me want to actually see the future of where I want to keep my career. Caring and respect are everywhere. You can sense it. We have seen in the past year or two more women in higher positions. As well, last year, Maravai offered a contribution match for any Black Lives Matter donations. We have people from many backgrounds, people from different countries working together. You know, we've seen growth more than double in the past two years. Everybody has been able to come together, and I feel that my contributions are important. I not only do my work for my organization, but I look at what's happening around the world, and I know that everything they're saying in one way or another has a connection with what we do here. Our work is part of a solution to a problem worldwide. I wouldn't change it. Well, thank you, Kevin. I'm tempted to end the whole day on that very high note, but I think we are obligated to take a few of your remaining questions, so we're happy to do so. I guess let me turn it over to Deb to emcee the Q&A session. There may be a slight delay as we do this. Thanks, Carl. This Q&A session will be the same as the first. Analysts in the Q&A room, please raise your hand, and for others on the webcast, please enter your questions in the question box. For this session, we'll have Carl, Christine, Brian, Mike, and Kevin all available to answer your questions. Rebecca, let's start with the analyst room. Our first question will be from Daniel Arias from Stifel. Daniel, please unmute your audio and video and ask your question. Yep. Hi, guys. Thanks for putting all this together. I just wanted to follow up on Matt's line of questioning during the first Q&A session and ask about the HCP ELISA business because, you know, to his point, when we were going through the IPO process, you kind of did talk about competition and your high share as being the rationale for some moderation and growth in that piece, which is the largest segment of the Biologics Safety Testing. To the comments that were made, I mean, it doesn't really sound like you're sort of ceding any of that market position. Is moderation still the right way to think about that, or can we keep that flat or maybe even grow that portion of that business? Well, why don't we ask Christine to comment first, and then Kevin can fill in if he has anything to add. We had an extraordinary year last year, and we did see some COVID fueling, as we posted those results from last year. Any non-mRNA COVID vaccine program we support from Cygnus Technologies with our analytics. We continue to operate broadly within that growing market. We've seen the acceleration of the cell and gene therapy space, which uses the novel expression platforms that we spoke about earlier. Cygnus Technologies is the only organization that has analytics for the broad range of those platforms. Novel platforms such as Sf9 and NS0 are used in some of these applications, and we have generic off-the-shelf kits for the early program development of these novel technologies. We also partner with our customers in terms of making sure that the analytics are fit for purpose with the services that Eric detailed, and we feature in the INDs and BLAs, so very, very sticky for the lifelong, you know, of the products. Kevin, anything you'd like to add? No, I think that's a good summary right there, Carl. Okay. Thanks for that. Just maybe a follow-up for Carl. Carl, how much more, Kevin for that matter, how much can price play a role in the CleanCap business going forward, just with the thought that, you know, Pfizer was buying so much from you that I imagine their volume-based discounting was about as good as it gets. I know you're not trying to make life difficult for your customers, but presumably with some of these smaller projects and with relationships that are a little different than they were, you know, in the early stage of the pandemic, it seems like there's room there for you to be more aggressive on price. Is that the right way to think about it or not really? Kevin, you want to take a shot? Yeah, sure. Look, I think we've always been very disciplined with our overall pricing. You know, from day one, a lot of our contracts had kind of multi-year components to them. You're right, it's really been about volume, for us. The more you go up on the volume scale, you know, the more we can volume price discount. You know, as we sit here today, I think we're happy with the stability of the pricing. We're happy with the margins. We're happy with the demand. You know, I think that we'll continue to evaluate that as we go forward. You know, at this stage, I think we've set pricing. We've been very disciplined with both CleanCap pricing at the high end of the scale, so when you're selling kilograms worth of products, all the way down to the lower end research size. A lot of the jobs we custom quote that are in the GMP suites and things of that nature have very, you know, disciplined margin calculators that we use. At this stage, really it's about us having the capacity, which we do. It's about quality. It's about on-time delivery. Pricing has been consistent, stable, and, you know, not. I wouldn't say we would look to take up price going forward. I think stability in pricing is really what we're focused on as far as our projections and our strategy. I think I would add that in an inflationary environment, obviously our contracts have some provisions for CPI adjustments as appropriate. We'll make those kind of adjustments. I don't think in the current environment, especially given what the world is trying to do with vaccines, that we're gonna be very aggressive on price increases in the future. Okay. I'll hop back in the queue. I know there are a couple of guys still looking to jump in here. Sure thing. Thank you, guys. Yep. Okay. Thanks, Dan. Rebecca, can we now go to the next question, please? Our next question comes from Paul Knight from KeyBanc. Paul, can you please unmute yourself and ask your question? Yeah, thanks, guys. Carl or Kevin, or who's the right person, could you square up at June you had mentioned 13 signed customers, up to, you know, the total was up to 50 that you were hoping to sign. And that, what is that group of customers versus the 500 plus customers you mentioned earlier today? What's kind of the square up on that? Yeah. Paul, we were talking, I think at that time, about the number of customers that have signed license and supply agreements, not necessarily customers who've been using the product without going to that next step. We'll have an update for you on that at our earnings call here in the not too distant future. Okay. Regarding the technology that's linked to the mass spectrometry, is it going to be generic for the mass spec marketplace, or is it a particular vendor that has that type of technology that you'll use? We actually do that or offer that as a service. What would happen typically is a customer would come to us and ask for a quote for that particular service. We then provide it, and the combination of the AAE, which is our own proprietary methodology and would be used in this case for sample prep, would then be combined with mass specs in our own facility. Not being distributed out. Okay. Thank you. You bet. Thanks, Paul. Okay, Rebecca, let's stick with the analyst room for the next question. Our next question comes from John Sourbeer at UBS. John, please unmute yourself to ask your question. Hi. Thanks for taking my question. You know, the opportunity around mRNA and cell and gene therapy sounds pretty exciting. You know, any way to q uantify this opportunity for Maravai and maybe, you know, specific to cell and gene therapy, you know, how many programs you're working on, and are any of these actually in the clinic today or what phase of trial these may be? Yeah, John, we'll have more to say on that in the future. As I mentioned earlier, we're doing an active study right now to try and determine the sort of market share, which is where I think you're headed there. The sizing of the opportunity, I'll tell you just from a dollar point of view, you know, we did work at the time of the IPO. We updated that work in November of last year, and the stuff that we did in November would be outdated today. That's how dynamic the opportunities are, and obviously those numbers are only getting bigger, not smaller. Thank you for that, and I guess, you know, appreciate the color on CleanCap or co-transcriptional capping earlier. You know, any thoughts on the competitive landscape there and any changes? You know, there were some announcements back in the fall with some synthetic biology players potentially partnering with some established players there. You know, anything changing you're seeing on your end? No, we're not seeing anything different. I think that was a comment that, or a release that Kevin was referencing there. Sometimes you just need to say, "Show me the data," and we feel pretty comfortable that the performance of CleanCap in the hands of our customers does speak for itself. I would also just, you know, reemphasize that these platform decisions were made long ago generally by the key players today. They selected their method, and they've stuck with it as they went through their own warp speed development efforts. We feel very comfortable about our presence in the largest players in the field right now. Great. Well, thanks for taking my questions. Sure. Thank you. Thanks, John. Carl, we have a question coming in on the web platform related to quality control. How does quality control work? How do you ensure the quality of the product, and which tools do you use for this? How much is sequencing used as part of this, and at what stages? Sure. Well, it's a great question. Obviously for us, ensuring the quality of our product is the most important thing that we do as we're providing it to our customers. We have a very large quality organization divided into quality assurance and quality control functions that is responsible for helping us maintain that level of quality. The company is governed by a quality management system, which is fairly typical in the industry, and we are installing automated tools to help us further advance that system. We use a number of analytical methods, and actually in this field, one of the underappreciated things that our KOLs were speaking to earlier today is that you're analyzing things that have never been analyzed before in many cases. You need to develop the analytical methods necessary to support your own quality initiatives and improve the performance of the product. We are very active in the development of those. Sequencing is used at various points along the way, particularly when you're thinking about the DNA sequence that you're gonna use as your plasmid at the starting point for manufacturing mRNA, and it's one of many tools that our team uses. Great. Thanks, Carl. Rebecca, can we go back to the analyst room? Our next question comes from Matt Larew from William Blair. Matt, please unmute yourself and ask your question. Yeah. Thanks, and good afternoon. Wanted to follow up on MockV. I think you said you were excited about the near and long-term potential there. Just curious what the sales cycle looks like to get that into customers. Are they typically doing redundant studies when they're outsourcing to a CRO? Is that, you know, sort of sold to a program manager, or is that potentially like an enterprise level sale to like a chief scientific officer? Sure. Let me ask Christine and Dave to comment on it since they've lived it. I would tell you that the timing of our launch coinciding with COVID was not particularly easy for anybody because of the restrictions on physical visits, but with that, Christine. Typically, where we're working with our customers is on the process engineering side and then in the laboratory application. As you saw in the video, we actually partner with the developers of the process so that they can bring this analysis in-house as opposed to outsourcing it. Gives them a lot more control and a lot more early indication of the viability of their process. To answer your question, you know, the thought process whenever we're talking to customers is to demonstrate the value early on that process engineering side, and then they bring in their laboratory authorities and partner with them to get the product into the lab. Okay. The second relates back to the two panelists. I know they're not with us. A couple of things they mentioned as focus areas were tropism and improving protein secretion. I'm just curious if there's any role that you can play there with your customers or if a lot of that is done by the therapeutic companies themselves. If there's anything you can do, it'd be piece one. The second would just be maybe an update on your thoughts on the LNP market. Again, dial back that discussion. It still appears to be extremely fragmented, and it may be underdeveloped and an opportunity for consolidation. Yeah, I think that a lot of the work that you're talking about is in fact done by the customers. What we're focusing our research efforts on is trying to understand ways that we can improve expression translation, transcription, along that continuum. But there, as Mike mentioned, there are slight subtle changes that when made can have material effects, both good and bad, and we're consistently and systematically characterizing those in our domain so that we can provide the customers a library of possible solutions, you know, in particular problems that they have. I'm sorry, the second part of the question, Matt, was? Yeah, just, you know, the LNP market is something I know you discussed in the past, and it's kind of a fragmented- Oh ... maybe a sort of underdeveloped space, and just would be curious to get your thoughts and if there's an opportunity for consolidation there. On LNPs, I do believe that the behavior is actually pretty similar to what we've seen with CleanCap, which was everybody who had an mRNA platform at the inception of COVID stuck with that lipid program that they had at that period of time. Now we're seeing more movement with people, more people entering the lipid space. You got to divide it into two things. One is the sourcing and supply of the lipids themselves, and then the second is the actual manufacturer of the lipid nanoparticle. I think I know for a fact there's a lot of IP around both of those aspects, if you will. I think people are not... I don't get the sense that people are dramatically changing, but a lot of the research that's being directed, as you heard this morning, is focusing on optimization and in particular the organ delivery. How do you get it out of the liver, and how do you get it to what you're interested in? In some cases in the immuno-oncology field is how do you get it into a tumor? Okay. Thank you. You bet. Thanks, Matt. Rebecca, can we go back to the analyst room for the next question? Our next question comes from Brandon Couillard from Jefferies. Brandon, please unmute yourself and ask your question. Hey, good afternoon. Carl, just one clarification. I believe you framed the addressable market growth as something like 7% in your introductory remarks. Just elaborate on the delta of that number relative to kind of prior sort of high teens, 20% growth rate you talked about for the market historically, especially now that you're out of protein detection. What's the difference there? It's the billions of dollars that got spent last year. It was the growth attributable to COVID and that extreme contribution in 2020 and 2021. Now the base is much larger obviously, the math just says it's gonna grow those rates. It's consistent with the overall life sciences market as we project it today. Any chance you have an estimate if we sort of just stripped out COVID programs, what sort of base market growth rate would look like? Oh, gosh, I can't tell you that for sure. But I would say that, if you think about it, when we started this, what did we say our addressable market was around the IPO time? About half of the number that we just discussed. I think that gives you a sense of what's happened in the last year and two months. Understood. Okay. Thank you. You bet. Thanks, Brandon. Rebecca, the next question, please. Our next question comes from Matthew Sykes from Goldman Sachs. Matthew, please unmute yourself and ask your question. Great. Thanks very much. Just one quick question for you, Kevin. As you kind of laid out the CapEx plans, and you've already planned for, you know, I think you mentioned $2 billion, I believe that's for nucleic acid, going forward. But as I think about that slide with, as compounds kind of move through the pipeline and the quantity of materials needed accelerates so fast, how do you think about planning that CapEx to prepare for that eventuality of the significant kind of quantum leap in materials needed? And will your CapEx plan eventually become rather lumpy in order to prepare for that, or can you scale it up? Is it a linear relationship between CapEx spend and that chart that we saw? Yeah. I think there's a few things to look at there. First and foremost is that, you know, we're always looking out 18-24 months in advance to make sure that we're, you know, putting in the infrastructure to where we think the market's gonna be and demand's gonna be, and that's certainly served us well. We have the capacity to meet all the demand we have here in 2022 with our existing facilities. The things we're bringing online in the second half of this year are really to address 2023 and beyond and the demand that we're seeing. I think the ongoing investment in facilities will continue. You know, I think we'll continue to be looking to add facilities in the right locations to complement what we have and potentially look at other locations internationally as well. That's all one part of it, and that part of the CapEx I think will start becoming a little more steady, probably a little less lumpy than we've seen in the past, frankly, 'cause I think we'll continue to look. The second area, some of the things that Mike and Brian have touched about is just the manufacturing efficiencies, the scale, things like continuous manufacturing versus batch manufacturing, and all the improvements we're getting that allow us to continue to scale up, not only what we're doing today, but some of the additional things that we're looking forward on, that Brian talked about as far as the pipeline's concerned. That's internal processes, equipment, and people, a lot of that we're really focused on right now. It's a combination of not only the physical footprint, but the process improvements and the scale and the efficiencies that we have and the expertise that we have to be able to do these things at high quality and high scale. You know, we've always kinda had that, you know, 2%-3% of maintenance CapEx and then these spikes, but I think as we look forward, we'll probably be a little smoother going out just because we wanna continue to make these investments, and the return on them, historically and what we're modeling as we look forward are extremely high. We're continuing to support our businesses with capital and with people, and that's really what our focus is, and that's really been the successful formula for us so far. Great. Thanks very much. Appreciate the day today, everybody. Thanks. Thanks. Hey, Carl, let's take one from the web platform. Has Maravai explored opportunities for automation for R&D and process chemistry development applications? Well, it's a great and very insightful question. We were probably a little bit slow at that in the past, but I think right now it's a key focus for us. The automation, especially of some of our chemical synthesis processes, is a top priority, and Mike and his team have some very interesting approaches to doing that. You know, we have scaled or changed our scale of operation almost 1,000 in the past couple of years as we've moved facilities, as we've gone up that curve that Brian showed us. I think it becomes an important part of what we're doing in process chemistry that begins in R&D, and trying to automate some of the ways that we do these developments. The answer is yes. Great. Thanks. Another question from the web platform. If you were to see 50% growth in the demand of your nucleotides, would the manufacturing footprint today be able to support it? Brian, that sounds like a great question for you, and I'm curious as to the answer too. Well, it's actually a pretty easy one. The answer is yes. You know, we have, you know, built this facility in Wateridge to ultimately be able to add an additional manufacturing line, which we haven't done yet. There's a doubling right there, and then there's also some shift opportunity here as well in the current building. It kinda gives perspective on the new Flanders building, where we'll also be building out more capacity that's somewhat equivalent to the type of manufacturing line we have in Wateridge, but we have space reserved in there to go even bigger than that. I think we have lots of runway from that perspective. Great. Thanks, Brian. Here's one more from the web platform. Are there any manufacturers that have capping technology that achieves the same one-step process as CleanCap? We are not aware of them. Great. Rebecca, let's take the last question from the analyst room. Our last question from today is from Tejas Savant from Morgan Stanley. Please unmute yourself and ask your question. Hey, guys. Thanks for the time here again. Just a couple of quick ones for Mike, actually. Mike, what's the regulatory hurdle for current users of CleanCap technology to switch to, you know, some of the next gen extensions that you mentioned? I was just trying to get a sense of whether these new sort of CleanCap modalities are more for new adopters of the technology or even existing users already in the clinic or commercial with their products. I should start off by saying I'm not a regulatory expert. To make a significant change like that might require some sort of bridging study or, you know, something along those lines. It could be in animals. I mean, you know, it depends how the FDA is feeling when it comes to that. You know, typically you make the decision for what you're gonna use going forward, prior to your pre-IND tox package. It can be a pretty difficult change, and it can add a significant amount of time to people's development timeline. Yeah. Tejas, I think we would agree that changing existing platforms, especially if you're doing billions of vaccines a year, is probably not easy, and it's probably not something that would be done. Given the number of new customers that we have and the numbers Brian shared with you, we see ample opportunity to introduce those kind of changes and let the customers make the decision very early on. Got it. In terms of, you know, CleanCap having, you know, lower immunogenicity potential versus some of the other synthetic cap analogs, is that a feature that you expect these new extensions will also retain? Mike? You know, I think that's a really good question. You know, in my mind, I've always thought, you know, we develop a CleanCap analog for vaccine purposes. It might be able to stimulate some aspect of the immune system, whereas in other cases we might have something that's more benign for making of a therapeutic. When you test and look at those things, for instance, if you run a cytokine panel y ou tend to generate a lot of noise when you're looking at these things in animal models. It's a really difficult thing to understand. Got it. One final one for Kevin here. I'm not sure you can answer this, but I'll try anyway. If you were to strip out, you know, COVID related CleanCap revenue from the model, Kevin, of the sort of medium term here, can you just give us an updated sense for what the base business will grow at and what EBITDA margins for the rest of the base business will look like? I appreciate the question, Tejas. I mean, look, I think what we've seen over the past nine months has been great. I mean, looking back from, well, the last 12 months, but we're just reporting the nine months in this package, that 50% growth that we're seeing is great, and you have to take that in the context of, you know, not everyone being at their bench as well. You know, it's, we're still in this period of recovering from a labor perspective and getting people on their missions that they intended to do. So we feel real good about that growth rate, even though those numbers are increasing. You know, we continue to see that as a very good trajectory for our core business. It's, as I said, it's not slowing down. I think, you know, Brian obviously talked about some of the numbers on February 23 during our earnings call. We'll get into more of that detail, talk about the fourth quarter of the year and our 2022 extended guidance, and we're looking forward to updating you with some of those statistics and being able to answer that a little more directly. All right. Fair enough. Appreciate the time today, guys, and this was great, so thank you for hosting the Analyst Day. Well, thank you, Tejas. We appreciate the feedback. Deb, I don't know, are we gonna do any more questions, or do we have any more questions here? That's it. We've gone through all the questions, so thank you all for participating. Let me and Deb maybe I'll just add a final comment. We hope today established for you a good understanding of the exciting technologies and science that we're pursuing. We like to leave people with a very clear message, and that message today is we feel we're targeting the right markets. We're well-positioned from a leadership point of view in the markets that we have chosen to go after. We see an ample opportunity in front of us on multiple different fronts, and we couldn't be more pleased to be one of the leading commercial partners in mRNA development programs globally. And finally, we want to reassure you that we are building this business with the expectation of long-term growth opportunities and being able to meet and sustain those growth opportunities. With that, Deb, I'll turn it over to you to say goodbye. Great. Well, thanks Carl, and thanks for all of your questions today and being part of our first ever R&D day. We, as I said earlier, will have this available on replay at our website, so we hope you can go back and re-listen to pieces you know want more information for. On behalf of all of us at Maravai, I thank you for participating and hearing about our exciting opportunities, and we hope you have a great afternoon and a wonderful weekend. Thank you. Thanks.