Good afternoon, everyone. Welcome to RBC Capital Markets 2024 Global Healthcare Conference. I'm Conor McNamara, the Life Science Tools and Diagnostics Analyst at RBC. It's my pleasure to have Maravai on stage. With me today are Trey Martin, the company CEO, and Kevin Herde, CFO. Gentlemen, thanks for joining us.
Thanks for having us.
Yeah, thank you.
Trey, let's just start with you. Just, we're gonna start high level, then we're gonna go into kind of, you know, the recent quarter and the near term, and then we're gonna get into things ahead if that's okay with you.
Sounds good.
So, just high level, you joined the company. You've got arguably more experience in this space with what you did in the business you sold to Danaher. Just give investors a little bit of background about what attracted you to Maravai.
Sure. So I've been in, now for 30 years in synthetic nucleic acids. And I had the benefit of working with the founder of IDT from the very beginning of my career, growing that into a very large business that, as you said, we sold to Danaher. The foundations there were in nucleic acid chemistry. The chemistry makes, in that case, the synthetic oligos, which ultimately led to synthetic genes. And honestly, it was a scale-out business. Here in healthcare, we talk a lot about scale-up businesses, things progressing from phase I, phase II , phase III clinical trials, you know, bigger bulk lots of the same thing. But in that case, we scaled out from tens to hundreds of thousands of custom sequences per day. And of course, those have applications in basic research and diagnostics and so on, also with synthetic biology.
What I saw in Maravai was, interestingly enough, one of the companies Maravai had brought in, TriLink, was founded by the last person to have my job at IDT in Iowa City, Iowa, small world, but also a company that had the very, very strong base in nucleic acid chemistry but had pivoted to therapeutic applications and had been fostering the semi-nascent mRNA space well before the pandemic, actually into the early 2000s, with some of this custom nucleic acid chemistry and indeed RUO mRNA services.
Of course, the pandemic brought Maravai fully into light and had the company scale from RUO chemistry to full GMP chemistry, inclusion in the COVID vaccines and billions of doses, which nicely, of course, proved the safety and efficacy of our technology and approach, and opened the door, I hope, for the next generation of programmable medicine, which is mRNA and CRISPR, where regardless of the end game for a neoantigen, for an infectious disease vaccine, or for a personalized cancer vaccine, or a protein replacement therapy, or a you know translating the protein for endonuclease and CRISPR gene editing, all of those mRNAs I just described are made roughly the same way, and they're just a configuration of nucleic acid sequence.
So at the end of the day, this, this medicine, will come full circle and will be programmable by scaling out the number of custom sequences that can be synthesized in a given day and a given time. And so it's hopefully the next arc for me is helping in therapeutics.
Okay. Thank you for that background. One of the questions I get a lot from investors or one of the concerns about your stock or your company is Maravai is a COVID company, and Maravai, all they make are mRNA vaccines, or they're an mRNA vaccine company. I eloquently usually try to say that's not correct. But when if you were given that, how would you respond to that to investors?
I would say that's not correct.
Okay. Well, investors want more than that, unfortunately, Trey, but.
Well, absolutely. So, look, COVID CleanCap was a massive sea change for this company. Maravai, first of all, was a focused consolidation of scientific founder-driven category-leading companies. So Maravai is TriLink, which has the CleanCap technology, but it's also a company called Glen Research, a biologic safety testing company called Cygnus, most recently an enzyme company called Alphazyme. So there are several companies in our family. CleanCap got all of the press because CleanCap went from being a differentiated technology in research mRNA to being chosen to be in the Pfizer-BioNTech vaccine. And we went from making grams of RUO-scale chemistry to making kilos of GMP-scale chemistry. And of course, that drove an amazing amount of revenue and changed the company substantially.
The outcome of that is, like I said before, we have the safety and efficacy of our chemistry and our approach proven now in billions of doses of vaccines. But we also have four new facilities, two more acquisitions, and $0.5 billion cash in the bank for what will be the next generation. Sure, there will be infectious disease vaccines. mRNA is really the best possible modality because you can go so quickly from sequence to shot. But I'm excited about the applications in oncology and gene editing and protein replacement therapy and everything else. Certainly, you could look back at the pandemic era 2021 and 2022 and say, "Most of the revenue came from COVID CleanCap from Pfizer." But all you have to do is look at our, you know, at our 10-K and see that that wasn't the case in 2023.
And so now we hope to build a broad and diversified base of business with the unique position that we span first products and technologies from RUO to GMP and now, in support of those products, service element that spans from RUO to full commercial-scale GMP. So all of those elements are what Maravai is, not just COVID CleanCap.
Thank you for that. I'll come back to that a little bit when we talk about longer term. Just maybe, Kevin, this is probably well, this for you, this is probably both for both of you. In Q1, you outperform your guidance, you outperform expectations. You look at what you're guiding for the second quarter. It implies roughly a flat first half to second half, which if you those of you that know the Life Science Tools space right now, most are facing a tough first half, and most are assuming a ramp in the second half. So I understand if there's some conservatism, you don't have to admit that.
But is there anything you're seeing in markets that would say, you know, maybe there won't be a ramp in demand in the second half versus the first half because maybe the biotech funding isn't flowing through, or pharma still isn't spending, or researchers are pulling back on the dollars? Is there anything that you see like that that led to kind of the way you think about the second half versus the first half?
You know, Conor, I'll take that, Conor. I would say that, you know, we don't see the year that much differently than we did when we gave our initial guidance three months ago. You know, what we get visibility to, the changes, timing are, you know, bulk orders of volume that our customers place with us, that run through our nucleic acid production segment predominantly, as well as the scheduling out of GMP jobs. So part of what we do is on the GMP services side where we incorporate our technologies into, you know, mRNA builds and do that as a service for a fixed price, much like some of the traditional CDMOs will do.
So we have visibility, and as those things move around a little bit, and you'd see if you know our history that our quarters don't always go in a linear fashion just because of how our customers want our products. And ultimately, that's what we're here to do, is provide them what they need when they need it and meet their schedules. So, that's just the way of saying we'll see some volatility throughout a given quarter to quarter. But overall, I think we feel as equally balanced on the years as we've recently guided. I think that's a good thing for us, certainly given the coverage we have in the second quarter. We feel good about the revenue projections there. And I think we'll wait and see on what that means for the year after report Q2.
I think we continue to see a range of outcomes. But I think on a whole, we feel about the same as we did three months ago with the overall market, which is, again, I think, a leveling out and a generally positive and cautiously optimistic tone.
Great. Thanks for that. If you just so, Trey, we've got, you know, if you look at the cell and gene therapy market, there's roughly, give or take, 2,000 programs in either discovery, preclinical, or in the clinic. And maybe there's more, maybe there's less. But how do you think about the health of those of that market, cell and gene therapy research? And of those 2,000 programs, how many do you think you are currently involved in?
Well, so here we'll give a little airplay to our other segment, which is biologics safety testing. You know, that segment really comprises our participation in what I would call the biologics market writ large. And one of the things that we continue to trumpet is that all of the FDA-approved cell and gene therapies here in the U.S. are QC'd with Cygnus kits. So there are many biologic-driven cell and gene therapy programs that are using viral vector gene therapy, for example. What we're the clinical data that we recently gave in Q4 was specific to mRNA programs. And there that was about 1,000 of the 2,000. So there are broad categories here. And one of the things that obfuscates the number of programs is that mRNA can be a vaccine. It can be a protein replacement.
It can be a tool to create a cell or gene therapy. CRISPR gene editing is the same thing. It can be a direct therapy, or it can be a tool to engineer a cell therapy. So we were specific, having done some third-party work and a deep dive to our participation in mRNA programs, at about 35%. In that case, about 350 programs.
Okay.
Cell and Gene Therapy, I'll knock wood, that Cygnus so far, on the biologic side is participating in 100% of those programs in their niche, of biologic safety testing.
Once those are approved, or is there participation prior?
Prior, for sure. In fact, Cygnus does more work with partners early phase while they're doing their process development. So they actually consume more Cygnus kits in, you know, preclinical phase I and process development. But then, of course, we're spec'd in and stay with them through commercialization.
And in the queue, thank you. Then in the 350 mRNA programs within the cell and gene therapy on the non-Cygnus side, what's the typical revenue ramp as a program goes from preclinical to phase I, phase II, etc.?
We actually showed some data like that, I believe, in a quarter that preceded me. So maybe I'll tap the resident historian to talk about what we've seen.
Yeah. I think it was a 10x number or something like that.
Yeah. And again, it all these programs will vary. I think, you know, one of the things, again, getting back to being a vaccine company versus, you know, a tools company, which we are more broadly, certainly, is the level of mRNA that you have in different end applications is incredibly different, right? A prophylactic vaccine's going to be very small.
Right.
Something that's doing a gene or cell replacement that's going to be substantially larger and could dose multiple times in a given year. So you have a wide range of potential outcomes here, as far as the amount of mRNA or the amount of capping material that you'd need that correlates to that mRNA. But generally speaking, we do see nice inflections as we stay with people through phase progression. And that's a big part of the future Maravai as we sit here today. We historically were very successful and continue to be successful in the discovery side and the research side and the preclinical support. But where we start to get bigger inflections and bigger moves is when people go to phase I, phase II, phase III, and obviously what we've seen with the commercial impact of vaccines and because of the volume demands that those include.
The nice thing about where we are today, we're still growing. We're still successful. We like our position. But we haven't started stacking multiple approved products yet. Really, that is when we look forward over the next, you know, 5 years -10 years, specifically as mRNA modalities move more into the later stage and hopefully multiple approvals come, that's when you really start to build in that annuity stream with your participatory in your technologies or you're building it or both. And we're unique because we're one of those companies that provides both the products and the services.
So as we start stacking those approvals, you do move from a lower run rate of dollars to a nice inflection when they do a phase II build, for example, then they might go away for three or four quarters and then hopefully do a phase III or get approved and then you start to see that build up. So they can be, you know, go from a $1 million to a $5 million to a $10 million campaign, then hopefully something at that level in perpetuity annually that once they get approved is really kind of how we can build our business over and above the market growth rates that we're already seeing.
Great. And does having the GMP facility online now, does that allow you to address more of those programs as they go from you know, as they go into phase I? Because you've got to have GMP product to go into phase I. Is that correct?
Yeah, for the API, you do. So it's something included in the final product. But we really have, first of all, scaled. So Flanders One, the facility has scaled to commercial-scale cGMP inputs like CleanCap, like NTPs. We are working on the same transition for our enzyme business. And then Flanders Two is the service-oriented piece, the building specifically designed to do full mRNA builds. Under the delta for us was that we were supporting many. We've actually done over 100 GMP mRNA runs, preclinical and phase I in our prior building. But we needed a different level of facility control and quality system to support phase II, three, and commercial. So what we just opened last month, Flanders Two, is our new essential asset that allows us to support people all the way through if need be.
Got it. Okay. At what point in that process does Maravai get spec'd in on these programs?
Typically, you're completely locked at phase two plus. But very often, well, I mean, honestly, with the long history in discovery, one of the reasons you hear us talk about winning in discovery is that very often people will, you know, accumulate their data and stick with particular technologies like CleanCap all the way through from discovery on.
Yeah.
In fact, almost all of our GMP service business starts in discovery.
Okay. Is there an opportunity for you to take other, you know, you get 35%, you have 35% of the programs as the other 65%. As they go into phase II, is there a chance, is there an opportunity for you to win that business now that you have the capacity?
There is certainly in preclinical, a little bit in phase I. What we're seeing, though, is, you know, the mRNA industry is still relatively new. And one of our later phase commitments was not taken from some other CDMO, but is a conversion from in-house production. So we think there's quite a bit of opportunity there where so far, companies have been doing their own work internally. Obviously, they need to switch over when it's phase II plus. And so that's a conversion to us either just on the service and sometimes on the chemistry.
Okay. And that's what's the sell of why would you switch from enzymatic capping to CleanCap? And I assume that's what you're talking about. Is it or is it?
Well, this was just internal production to outsource production to us. But the reason that CleanCap is so great is that it is a, well, it's called co-transcriptional capping IP. And the point is actually not only a reagent, but a method of producing mRNA in a way that saves an extra purification and an extra step. So it's actually faster and higher yielding. That's the process improvement that led to the first three caps. The first of the new generation of caps, M6, is one that includes all the process benefits but adds a functional benefit in that we're now tweaking the chemistry in ways that have functional benefits in vivo. And the example in M6 is that we get higher protein expression per molecule, with this chemical modification. So we call it the Gen II of the caps.
I'm really excited biochemically about what we can do with that going forward. That's the first of what I hope for many.
Great. You recently announced an agreement with Lonza for CleanCap and their mRNA programs. Can you just walk through, you know, what's the opportunity there and what is this or is this signaling thing? Is it, you know, they're going to switch everything over to you guys? How big of how should investors think about this opportunity?
We want to make sure that we get the best possible chance to help all programs succeed and participate in them, obviously, as much as possible. So we know that even though we have now full clinical scale capability, that there is regionalization. You'll probably recall that in Q4, we announced a partnership with Fuji in Japan. So Fuji in Japan, Lonza in Europe, you know, thematically, there is regionalization in CDMO services. There are people that have a significant scale, Lonza's, you know, an absolutely world-class CDMO. So we are excited to enable them, and they are excited to be enabled to support clinical trial builds up to and, potentially including commercialization. And that's just a recognition that our services will probably play in a certain part of the market, in a certain region of the market.
And we want, as you've seen with licenses to Thermo and others to seed the discovery space. And, with Lonza and Fuji to seed the CDMO and GMP space.
So I'm assuming you're not going to tell us the revenue opportunity there. What about the partnership with Thermo? Are you going to tell us? Is that?
Well, in all of these cases, we are selling a product and giving a license pass-through to Thermo, Lonza, Fuji. Their ability to sell and book contracts is what will ultimately determine the participation there.
Got it.
Which is why it's that would be a, you know, a derivative forecast for us. We want to help them be successful, and they want to be successful, so.
Got it.
All of those are great partnerships. You know, we are open to those because, again, the idea is to populate and seed the industry with the best technology.
Great. All right, guys. five minutes left. Challenges upon you. Let's see if you guys can multitask while I throw some questions at you. See how far you can get on the Rubik's Cube. I've asked all of my management teams to do this. No one's gotten close, so good luck. And luckily, you don't have a screwdriver because otherwise and he's going to do it. Well, there we go. See, this is the innovative nature of-
I remember in grade school, I would take these apart.
Now, my 11-year-old son is going to kill you, but no fun.
So what happens when you bring a scientist up?
Yeah. I don't know.
We're going to disassemble and reassemble. This is perfect.
Okay. All right.
Ask Kevin a modeling question.
No, I'm distracted. What did I say about multitasking? What about you mentioned the regional nature of the CDMOs? Any fallout from what's going on in China? And, you know, are you able there's a very big CDMO in China that I've, you know, we've heard may be losing some business to other CDMOs? How does that impact you guys?
Yeah. Our overall exposure to China is pretty de minimis. So it's about $15 million of revenue in total. We don't source hardly anything from the region, so we're protected there. Most of that exposure, 90%+ of it's in our biologics safety testing region. And it really follows, you know, where the CDMO work where the bioprocessing outsource CDMO work is. We use a distributor there and actually, you know, this last quarter was, I think, the second highest over the last five as far as revenue contribution. So it's leveled out. It's performing well. We're not baking in any growth there. And if anything, we have a pretty minimal exposure. And if that business were to move to another region, you know, those Cygnus kits are baked into the approvals, and they're going to follow that with it.
So I think it's pretty well covered there. If anything, just given we are a fully staffed, located, manufacturing-based U.S. company. So if anything, I think we're well positioned to probably be incrementally seeing net benefit from that.
Okay.
Versus maybe some other people that either have operations or have more products that are, you know, in China, for China.
Right.
We don't have a lot of exposure.
One of the things.
How's that going?
I need a tabletop. One of the things about.
You guys are going to miss your flight now.
Our approach is that we make the input reagents, so the NTPs, CleanCap, product level, and then we have the service level. And one of the things that we've certainly heard a lot from customers, even talking about the service level, is the idea of the supply chain. You know, so people are already thinking about supply chain as they enter into early phase programs. And, you know, 10 years ago, it might have sounded crazy to make GMP nucleic acid chemistry in San Diego and make input enzymes in Jupiter, Florida. But now it doesn't sound so crazy. And so we've got vertical supply chain feeding either other, you know, partners or feeding our service business itself.
Kevin, more for you since Trey seems to have his hands full. On capital allocation, you guys are in a great position, you know, from cash. You know, how much potential M&A is there still out there in the space? Maybe it's for both of you. And how do you think about M&A targets? Is it, you know, now you want to have a bundle strategy or are there specific technologies or do you want to expand into, you know, be bigger in viral vectors or how have you thought about that?
Yeah. I mean, part of Maravai, obviously, since day one is identification of acquisition targets, the evaluation and integration of them. I mean, that's what we've done, and that's what we've been successful at doing and have the capacity to certainly do both operationally as well as financially. I would say, you know, as we sit here today, there's a lot of very interesting emerging technologies that I think could be very complementary to what we do. I would say this we get a lot of checks on strategic fit and scientific opportunity. We've been getting a lot of minuses when it comes to my desk and we do the financial review. Unfortunately, there's a lot of companies out there that are, you know, in a tough spot. I would say they're interesting.
They're at a certain level, but they're not at a level that we're interested in acquiring them all out. So, you know, because of that, I think we're starting to look at alternative structures, which is not something we've done a lot of, you know, as far as collaborations or potentially license deals or other more innovative structure that aren't full M&A. We do still have some traditional companies we're looking at that I think would be good acquisition targets. And that's why we keep our growth sub-structure and, you know, keep that cash on hand that we have a net interest rate that's pretty effective to be able to work quickly on those deals. And we still see, but for us, that's, you know, $200 million or lower.
Yeah.
You know, and these are going to be founder-based companies or companies that aren't probably doing traditional auctions with the bigger serial acquirers. You know, let them play in that bigger space. We're going to find things that are very on point strategically, work with our customers' needs, and have a financial profile that is more mature than a venture-type equity investment. And that's, you know, that's so that's kind of narrowing the bottom of the.
Yeah. And there are enough targets out there for you guys?
There are. We're constantly diligent having diligence on multiple targets. We've just walked away from several already this year. And that's just the nature, again, of I think where they're at in their maturation process and some of the financial discipline we put into the diligence process.
Awesome.
Yeah, I would say one of the things that attracted me to Maravai with my history as a small startup that became a big company was really that scientific founder-driven focus. And the other great track record that all the Maravai acquisitions have is that they've been acquired and then invested in. You know, the play is upside, not necessarily looking for cost synergy, but looking for profitable, ideally, businesses that have a great category lead that are differentiated and can grow with the proper investment. And then now our shared service, particularly with Kevin's finance team, allows them essentially to transition into public life with a lot of the difficult things for a company like that handled.
Great. Well, Trey, Kevin, thanks for joining us. Really appreciate it.
Thanks, Connor.
All right. Safe travels back to San Diego.
Thank you.