Maravai LifeSciences Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 8, 2024

There are 14 speakers on the call.

Operator

Good day, ladies and gentlemen, and welcome to the First Quarter 2024 Maravai Life Sciences Earnings Conference Call. As a reminder, this call is being recorded. At this time, all participants are in listen only mode. Later, we will conduct a question and answer session where participants are requested to limit themselves to one question and one follow-up. Thank you.

Operator

I would like to now turn the call over to Debbie Harte, Head of Investor Relations. You may begin.

Speaker 1

Good afternoon, everyone. Thanks for joining us on our Q1 2024 earnings call. Our press release and the slides that accompany today's call are posted on our website and available at investors. Maravai.com. As you can see on our agenda for today on Slide 2, Trey will first provide you with a business update and Kevin will review our financial results and guidance.

Speaker 1

Drew Burch, President of Nucleic Acid Production and Becky Bozzio, our Chief Commercial Officer, will join the call for the question and answer session following the prepared remarks. During today's call, management will make forward looking statements and refer to GAAP and non GAAP financial measures. It is possible that actual results could differ from management's expectations. We refer you to Slide 3 for more detail on forward looking statements and our use of non GAAP financial measures. Our GIST issued press release provides reconciliations to the most directly comparable GAAP measures.

Speaker 1

Please also refer to Maravai's SEC filings for additional information on the risks and uncertainties that may impact our operating results, performance and financial condition. Now, I'll turn the call over to Trey.

Speaker 2

Thank you, Deb, and good afternoon, everyone. We appreciate having you join us for our call today. Let me briefly recap the quarter, highlight some innovative new products we are introducing and provide a few business updates before turning the call over to Kevin. Let's start with our Q1 results on Slide 5. Today, we reported $64,000,000 in revenue for Q1, dollars 8,000,000 in total adjusted EBITDA and a loss of $0.02 in adjusted fully diluted EPS for the quarter.

Speaker 2

Q1 revenue results Q1 revenue results exceeded

Speaker 3

the range of expectations that we shared with you during our Q4

Speaker 2

conference call. Our Nucleic Acid Production segment had revenue of $46,000,000 Q1. The biologic safety testing revenue was $18,000,000 in the Q1 and this was our Q1 of growth for BST since Q1 of 2023. Kevin will go into more detail on these results later in the call. Slide 6 shows that our adjusted free cash flow in the quarter was $4,000,000 Cash on hand at the end of the quarter was $562,000,000 down $13,000,000 from year end as we continue to progress with the build out and equipment installation for our 2 new Flanders G and P facilities.

Speaker 2

Debt is $532,000,000 gross. Thus, we maintain a $30,000,000 net cash position. This puts us in a great position to fund our long term growth strategy through organic investments, while simultaneously pursuing external partnerships and or M and A. We continue to see multiple potential strategic opportunities in our space where we will endeavor to responsibly deploy our capital. As we sit here today, we remain focused on our return to growth strategy.

Speaker 2

To enable long term sustainable growth for our business, we expect to continue to expand our product portfolio, advance our market leadership in the mRNA space and accelerate the introduction of scientific innovations in ways that support our customers rapidly evolving needs. To the first point on product portfolio expansion and our focus on innovation, let's turn to Slide 7 and some updates in our nucleic acid production segment. In our enzyme product portfolio, I'm happy to announce that our toolkit now consists of the majority of enzymes used in the mRNA IVT process. Incorporating Alphazyme enzymes into the TriLink mRNA workflow, which we trademark as CleanScript provides our customers with industry leading high purity mRNAs with increased activity and reduced toxicity. We recently launched over 20 new catalog mRNA products from our TriLink discovery group.

Speaker 2

This project leverages our decades of RNA experience through the incorporation of our industry leading capabilities in capping, base modifications and mRNA manufacturing workflows in addition to the enzymes manufactured at Alphazyme. As many of our discovery customers look to advance their programs from mRNA design to LNP or other delivery system optimization, they need to catalog mRNAs to rapidly advance their projects. With that in mind, we've launched these new catalog mRNA offerings with CleanCap M6 and N1 methylpseudouridine. This enables customers to use the best chemistry from the outset of their programs. In addition, we've refreshed the entire catalog using the latest version of our Clean Script IVT production process.

Speaker 2

CleanScript allows us to deliver the highest purity products that have reduced double stranded RNA levels and can enhance in vivo protein expression. The innovation doesn't stop with these newly announced catalog discovery products. We intend to launch many additional mRNA products as we move forward and we are engaging more deeply with customers as we support their research programs with custom constructs. Turning to Slide 8. We continue to bolster our market leadership in the mRNA space through strategic partnerships.

Speaker 2

TriLink entered into a non exclusive license and supply agreement with Lonza for clean cap analogs for use in Lonza's global mRNA development and manufacturing services from preclinical through Phase 3 programs. Lonza is one of the world leaders for producing biologic drugs. They've elected to bring CleanCap into their portfolio to enable many more customers to benefit from the advantages of CleanCap. And we see this as an important partnership for us to seed the market with our technologies. We believe Lonza's decision to incorporate our solutions in their highly regarded development and manufacturing services is a strong endorsement that Cleancap is the optimal way to produce mRNA and we are excited for this partnership to unfold.

Speaker 2

Alphazyme announced a collaboration with Applied DNA for scale up manufacturing enabling the linea RNA polymerase. Under the terms of the agreement, Alphazyme will perform manufacturing process development enabling the scaling of their RNA polymerase manufacturing from its current research scale to the commercial scale necessary to empower the growing demand for the company's Linea IVT platform. We developed a full enzyme production process and have made breakthroughs in the manufacturing workflow for Applied DNA. We're fully able to support their forecasted demand and help enable their growth. We also continue to foster key academic partnerships to enhance innovation and accelerate market adoption of the latest technology.

Speaker 2

We currently have active research collaborations with 5 top tier academic institutions to address a wide range of disease indications and custom nucleic acid applications, demonstrating our desire to be a technology partner to scientists developing the next generation of medicines. We believe that in new product innovation and partnering with leading academic and industry partners is a key driver for creating long term value. We are in an exceptional position to win customers early for product and technology adoption. Turning to Slide 9 and tying innovation to our commercial strategy, which is a critical part of our return to growth. Again, we're in a unique position producing the process inputs used in the IVT reaction as well as the full clinical scale production of mRNA.

Speaker 2

As we work to improve mRNA production, we see several opportunities to drive new product and process innovations to improve the overall manufacturing workflow. This is a luxury and that it helps us move the mRNA field forward in a unique and differentiated way. By winning early in the discovery process with our CleanCap and our CleanScript technologies, Our commercial team can cross sell NTPs, enzymes and other raw materials at earlier stages of the clinical pipeline, putting us in a position to grow with our customers to support them with their later stage development. This can include providing either RUO or GMP materials depending on their needs. This year has started with exciting positive momentum, thanks to the efforts from our commercial operations and business teams.

Speaker 2

We have made great progress in evolving and building our commercial team and building the flywheel between our products and services activities. As we continue to expand our customer funnel for RUO and GMP offerings, it is important that we offer an unmatched customer experience from day 1 and for as long as the customer is with us. Our enhanced commercial team has the talent, tools and processes to help build Maravai 3.0 in support of our return to growth strategy. Let's turn to Slide 10 and our Biologic Safety Testing segment updates under the Cygnus Technologies brand. As with the nucleic acid segment, we continue to innovate to bring improved products to market to support our customers.

Speaker 2

Cell and gene therapy development has experienced tremendous growth as the FDA and other regulatory agencies worldwide continue their efforts to enable innovators in this new class of medicines. The FDA and other global regulatory agencies have approved several cell and gene therapy products and we are very proud that Cygnus kits now support all 21 of the 21 FDA approved CAR T cell and gene therapies. We are also pleased that Marubai was recognized as among fast companies most innovative companies in biotech in 2024 for our Cygnus Mach V RVLP kit, which detects retrovirus like particles that can be produced during the manufacturing of biologic drug products. The kit, which uses a surrogate non infectious virus like particle can be run without extra safety and containment measures. This enables faster, easier and more cost effective optimization of viral clearance to assure biopharmaceutical safety prior to human clinical trials, regulatory approval and commercialization.

Speaker 2

This award adds to the many recognitions received since its introduction in 2022. We remain very optimistic about the Mach V product line and our ability to disrupt the viral clearance market. As in the NAPP segment, we plan to continuously improve our offerings in BST to ensure superior technical support, the highest quality services and offerings and the most comprehensive catalog of products to meet our customers' needs. Cigna's consistently supports and advances the technology to improve biotherapeutic safety and accelerate the movement of new therapeutic monoclonal antibodies, biosimilars and cell and gene therapies through the development and regulatory approval process. Now moving to Slide 11 and our facilities update.

Speaker 2

As many of you are aware, Flanders 1 is our new GMP manufacturing site for small molecules. I am pleased to report that we have produced our first engineering batch of GMP small molecule products in the new facility and are quickly migrating our CleanCap M6 to GMP quality. As we approach the 1 year anniversary of the M6 launch, customers have lined up for M6 GMP batches and are eager to move CleanCap M6 into the clinic. GLINDERS-one adds scale and mitigates operational risk as we now have redundant capacity to manufacture small molecules. This includes the CleanCap analogs as well as other NTPs such as N1 methylsuyauredine, which are needed as GMP grade inputs for mRNA production.

Speaker 2

This will not only bolster our supply chain resilience, Flanders 1 is a designated facility to aid the U. S. Government in future pandemic preparedness. We hosted our Flanders 2 grand opening in April and are now officially in the market for late phase cGMP mRNA production. Flanders II was designed to meet the manufacturing requirements of mRNA based medicines through all drug development phases.

Speaker 2

We have enabled mRNA clinical programs for over 10 years from discovery through investigational new drug or IND filings. Our new cGMP facility will serve our partners with late phase clinical and commercial mRNA drug substance manufacturing. The 32,000 foot facility includes 3 Great C manufacturing clean rooms, a dedicated fill suite and an independent buffer prep and staging area. We have on-site quality control, EM monitoring and release testing supporting 1 gram to 100 gram batch sizes. We couldn't be more excited to open our doors and help enable the life saving medicines our customers are developing.

Speaker 2

Many of our customers have been asking to stay with our talented team as their clinical programs advance into Phase 2, Phase 3 and beyond. And I'm so pleased that we can now support them. In fact, we have already signed statements of work to support a Phase 2 clinical trial and our first Phase 3 batches. We believe this is a capability extension that will make it easier for drug developers to select us for Phase 1 or even preclinical batches at the beginning stages of their development as they know they will have a partner who can support them through commercialization. We have a long history of innovation in mRNA.

Speaker 2

Our significant investment in these two facilities underlines our commitment to innovate the process for producing the next generation of genomic medicines and the raw materials that enable their production. This expands our capabilities to help our customers unlock the potential of mRNA and develop life changing vaccines and therapies. The Water Ridge facility will continue to support the important work underway in TriLINK discovery and act as a key partner providing development expertise to our customers. Moving to Slide 12, I'll now ask Kevin to provide more details on our Q1 performance and our expectation for the balance of the year. Kevin?

Speaker 4

Thanks for the hand off, Trey. Echoing Trey's remarks, we are pleased with the top line performance in the quarter and excited about the business accomplishments that are laying a solid foundation for our future. Today, I will summarize our financial results for Q1 and then discuss our reaffirmed financial expectations for the full year. Let's start with the Q1 financial results on Slide 13. As Trey mentioned, our revenue for the quarter was $64,000,000 Our GAAP net loss before non controlling interest was $23,000,000 for the Q1 of 2024.

Speaker 4

This compares to a net loss of $1,000,000 for the comparable Q1 of 2023. Adjusted EBITDA, a non GAAP measure, was $8,000,000 for Q1 2024 compared to $24,000,000 for Q1 2023. Our adjusted EBITDA margin was 12% in Q1 2024. Biff's adjusted EBITDA margin was slightly below our internal forecast for the quarter by about $1,000,000 partially tied to the timing of some operational readiness period costs for our new Flanders facility, which we are incredibly excited about. For the trailing 12 months or last 4 quarters combined, our adjusted EBITDA margin was 18% on revenues of $274,000,000 Overall, our adjusted EBITDA margin in any given quarter will vary primarily based on revenues given the high proportion of labor and facility related costs and the relatively low revenue based variable costs.

Speaker 4

As it relates to labor and our previously discussed cost reduction actions, you'll see on Slide 14, we ended the quarter with 5 75 full time employees compared to 673 employees we had at the end of September 2023 prior to our restructuring initiatives. And we completed all of the related actions over the course of Q4 2023 and Q1 2024. As we look forward, we continue to evolve our organization with an eye to the future. This includes continued investment in innovation, commercial infrastructure and GMP operations that are at least partially funded by the targeted reductions in our G and A structure and balancing our NAP operations team to the current demand profile. We continue to be focused on funding future growth opportunities while maintaining a cost effective structure.

Speaker 4

With 5.75 employees, our revenue per employee metric for 2024 is just under $500,000 in revenue per employee, which is amongst the best in life science tools. This coupled with the broad and expanding capabilities of Marabai positions us well for operating efficiency moving forward. I will discuss EBITDA by segment in a few slides. Moving to Slide 15 and EPS. Basic and diluted EPS for the Q1 was a loss of $0.09 per share compared to breakeven EPS in the Q1 of 2023.

Speaker 4

Adjusted EPS was a loss of $0.02 per share for Q1. Moving forward to the year end balance sheet, cash flow and other financial metrics on Slide 16. We ended the quarter with $562,000,000 in cash and $532,000,000 in long term debt, resulting in a $30,000,000 net cash position. Adjusted free cash flow was $4,000,000 for the quarter. That calculation of adjusted free cash flow, a non GAAP measure, is based on our adjusted EBITDA less capital expenditures, which were $8,000,000 $4,000,000 in the quarter respectively.

Speaker 4

For Q1 2024, cash used in operations was $8,000,000 primarily associated with the $20,000,000 in planned retention payments associated with the 2 year anniversary of the Mican acquisition. Capital expenditures net of BARDA reimbursements were $4,000,000 in the quarter. We anticipate our quarterly 2024 capital expenditures to peak in Q2 of this year corresponding with the final outfitting stage of our Flanders buildings. Depreciation and amortization was $12,000,000 in the quarter, which is in line with our expectations and previous guidance. Interest expense net of interest income was $4,000,000 in the quarter, slightly better than our expectations as our interest rate cap contract maintained higher values and excess cash yield stayed high based on the evolving expectation that rates will not shift downward in 2024 as quickly as previously expected.

Speaker 4

Stock based compensation, a non cash charge was $12,000,000 for the quarter also in line with our expectations. We ended Q1 with 133,000,000 Class A shares outstanding and 119,000,000 Class B shares outstanding for a total of 252,000,000 shares outstanding March on an as of fully converted basis, in line with our expectations for Q1 and flat versus the same time 8 year ago. Next to Slide 17 and the discussion of segment performance in the quarter. Our nucleic acid production segment which includes both our Discovery and GMP products and services, market under our TriLink Glen Research and Alphazyme brands, had revenues in the Q1 of $46,000,000 and adjusted EBITDA of $10,000,000 a margin of 22%, a lower margin than previous quarters as anticipated based on the lower revenue level over our cost base. Our Biologics Safety Testing segment, which includes products from our Cygnus brand, had revenues of $18,000,000 in the Q1 and adjusted EBITDA of $14,000,000 a strong and consistent adjusted EBITDA margin of 77%.

Speaker 4

As detailed in these segment results, the combined adjusted EBITDA of our operating segments prior to the corporate shared service expenses was $24,000,000 for Q1 2024, a combined margin of 37%. Corporate shared service expenses including the impact adjusted EBITDA, which includes centralized functions such as human resources, finance and accounting, legal, IT and the incremental expenses associated with being a public company, totaled $60,000,000 in the first quarter, down almost $2,000,000 from the comparable Q1 of 2023. Let's move on to our current thinking around the full year of 2024 on Slide 18. Based on a solid start to the year and our current assessment of the likely range of revenue outcomes, we are comfortable with the existing 2024 total revenue guidance range of $265,000,000 to $285,000,000 in revenues. Looking at the segments, our Biologics Safety Testing business printed a strong $18,000,000 first quarter, which we see as the high quarterly mark this year consistent with previous years and achieving an overall load of mid single digit growth over 2023 for this segment.

Speaker 4

After taking this estimated range for the BST business of around $65,000,000 to $70,000,000 for the year, we expect the NAC segment will be roughly $200,000,000 to $215,000,000 for the year 2024. As for the cadence of estimated revenues, we estimate the first half of the year now carrying close to 50% of the year, up from our previous expectation of 47%, which based on the midpoint of our full year range and the Q1 results would result in a second quarter revenue estimate at about $73,000,000 or so. So we see the top line firming up after a solid start and balancing the first and second half of the year. We anticipate that margin will expand from Q1 with the sequential increase in revenues as we have seen in the past. We see the range of our profitability metrics within the same range as our initial guidance.

Speaker 4

Adjusted EBITDA margin expectations of 23% to 25% and our full year adjusted EPS in the range of $0.00 per share to a $0.06 per share loss. Guidance also holds the following expectations in 2024. Interest expense net of interest income to be between $25,000,000 $30,000,000 depreciation and amortization between $40,000,000 $50,000,000 equity based compensation which shows the reconciling item from GAAP to non GAAP EBITDA to be between $45,000,000 $50,000,000 has a fully converted share count of 254,000,000 shares and an adjusted effective tax rate of 24%. Finally, net capital expenditures of $30,000,000 to $35,000,000 in 2024. Overall, a solid start to the year.

Speaker 4

I'll now turn the call back over to Trey. Thanks, Kevin.

Speaker 2

So to wrap up on Slide 20, we had a solid start to the year and are tracking against the revenue guidance range that we've communicated to you in March. We are executing on our return to growth strategy and year to date have introduced significant new innovations to the market that further extend our leadership across the entire mRNA production workflow, as well as increasing our manufacturing capacity at our TriLink Flanders 1 and Flanders 2 facilities in these high value areas. We have also strengthened our commercial team and continue to bolster our market leadership in the mRNA space through key industry and academic partnerships. Our TriLink, Glen Research, Alphazyme and Cygnus brands all continue to lead their fields, while pushing the boundaries of innovation to offer unique and even better solutions to solve customer problems and advanced discoveries. Our balance sheet remains strong and we are well positioned to execute on opportunities for inorganic investments to bolster our market position and provide our customers with additional solutions.

Speaker 2

We remain confident in the fundamental strength of our end markets and the value we provide our customers for the life changing development of drug therapies, diagnostics and novel vaccines. We remain committed to building strong foundation for the long term sustainable growth of our businesses. I would now like to turn the call back over to the operator to open the line for your questions. Thank you.

Operator

We will now begin the question and answer session. And your first question comes from the line of Matt Hewitt with Craig Hallum. Please go ahead.

Speaker 5

Good afternoon and congratulations on the strong start to the year. Maybe first up, congratulations on the Lonza contract. How should we be thinking about the ramp of that relationship? Is it something that will kind of build over time? Or is there an initial kind of order flow that you would expect and then kind of stabling from there?

Speaker 5

Just help us walk through that relationship a little bit.

Speaker 2

Sure. Thanks for taking my question. The arrangement with Lonza is similar to others we've announced where we just want to make sure that we open all avenues for customers' development programs to CleanCap and our other technologies. As you might guess, it's not an instant moment where things start up. It's an enablement that will take time build, particularly you see in GMP services and particularly at the high level Lonza operates that these are contracts that are negotiated several quarters ahead of time typically.

Speaker 2

So we would expect a ramp in the consumption. But again, the idea is to make sure that there are many avenues toward incorporating our technologies, whether we are producing or others are.

Speaker 5

That's great. And then maybe a separate follow-up question. I've been getting a lot of questions from investors asking about the BioSecure Act and impact that that may or may not have on respective businesses. And I'm just curious as it sounds like there's a markup meeting next week with the House. How would that impact your business, if in fact that becomes law?

Speaker 2

Well, there's definitely a lot of conversation about this. And like you say, it's not law yet. As we've looked at things, we have a significant proportion of our business in the U. S. And Europe.

Speaker 2

And from the perspective of CDMO Services, if something like that were to go into effect, we think it would essentially lead to a new equilibrium across geographies. And as we are majority U. S. And Europe, we would be able to participate in that.

Speaker 5

Understood. Thank you very much.

Speaker 1

Thanks, Matt.

Operator

Question comes from the line of Tejas Savant with Morgan Stanley.

Speaker 6

Hey, guys.

Speaker 3

Good evening and thanks for the time here. I just want to follow-up on that Lonza question from earlier, Trey. Can you just give us some color on how the deal came about? Was this unsolicited inbound? Did Lonza consider alternatives as they chose Maravai?

Speaker 3

And has this contract win sparked further discussions with either pharma customers or other CDMOs? And does it come with any minimum volume commitments at all?

Speaker 2

Great questions, Tejas. Let me hand that over to Becky, who was actually directly involved in those discussions. Becky, are you with us?

Speaker 7

Yes. Hey, Tejas. How are you doing? Yes. So look, I think this is really a broader strategy that we have.

Speaker 7

We see CDMOs as a very good channel for our GMP Biomanufacturing Materials and to enable the adoption of Clean Cap. We realized that, there are customers that have many choices and there are many choices to and certainly capacity, expertise and desire and different partnership structures that have with different CDMOs are all part of the driver of selection. So what we're looking to do is build enablement structures to partner with Tier 1 CDMOs that have a desire to partner with us. And yes, we have a contract with them. And so there's typically a mutual agreement around wanting to bring Cleancap in as a platform technology and then have a wide path for customers to have the ease of use with that CDMO and really streamline activities between the two companies and make it easier.

Speaker 3

Got it. That's super helpful color. Yes. And then Trey, one for you on the opening of the San Diego facility here. Is there a backlog of work that's already in place there or building up the book of business is still ahead of you?

Speaker 3

Just help us think through sort of the capacity utilization ramp at the site and what's the max sort of potential revenue that we can expect to see there over time?

Speaker 2

Sure. There is definitely a buildup to be had because in no small part because we did not have the late phase clinical capabilities from an infrastructure point of view until the opening of the facility. But I will hand it to Drew who has been living this life and give you some more color there.

Speaker 8

Sure. Good afternoon. We do have we have taken our first committed orders for that facility. It is as you would expect, it's a funnel we expect to continue to grow over time. But we have already contracted late phase mRNA builds for the facility.

Speaker 4

Got it. Thanks guys. Appreciate the time. Sure.

Operator

Your next question comes from the line of Dan Leonard with UBS.

Speaker 9

Thank you all. So I know it's gotten harder to unscramble the egg between what's COVID and what's non COVID nowadays. But as best you can tell, did the base business, the non COVID business with the nucleic acid production, did that grow sequentially versus the 4th quarter?

Speaker 4

Versus the 4th quarter? Yes.

Speaker 2

Well, and you're saying base non COVID Q4, Q1 sequential?

Speaker 9

Yes. It's best at first because I know it's hard to unscramble that.

Speaker 4

I mean Dan, I mean obviously we're not breaking that out now, so I can't directly answer the question. What I would say to that generally speaking is certainly the clay gas production business obviously was down versus the 4th quarter sequentially as expected. And one component of that were these GMP orders for Clean Cap, which we had scheduled coming into this year. And that took a step down from the run rate we had been seeing throughout the course of 2023. And that was the largest contributor to that sequential decline.

Speaker 4

I think that's the best way for me to answer that question.

Speaker 9

Got it. No, I appreciate that. Thanks, Kevin. And my follow-up, I could use a bit of help on the gross margin line. I know you said that margins came in near your plan, but I think perhaps our model wasn't dialed in appropriately and cost of goods were higher than we expected and they were up year over year despite lesser revenue.

Speaker 9

So how can we think about better think about the gross margin progression from here? Thank

Speaker 4

you. Yes, certainly Dan. Certainly gross margin as well as our EBITDA margin will fluctuate predominantly based upon revenues. And when you really take that down to next layer, it's within the nucleic acid production segment and even a layer lower tied to our manufacturing facilities here in San Diego, where we have the most substantial amount of fixed costs and overall labor. I think another component of that that we saw here in the Q1, which is relatively as anticipated, was just the mix.

Speaker 4

I mean, we did have a lower overall clean cap quarter versus some of the previous quarters we had seen and that's certainly a higher margin product, particularly when we're doing it at higher volumes and in sort of bulk to some of our larger pharma customers for their needs. So you'll see that margin ebb and flow a little bit with the overall volume of of Clean Cap when you look back at, say, the Q4 of 'twenty 3 or the Q1 of 'twenty 3, we had those larger Clean Cap quarters, you see those gross margins higher. And then I think as we go into the Q2, we do see a substantial step in clean cap based upon those contracted shipments that we have visibility to today. So lower revenue margin predominantly. And then I mentioned a little bit startup costs related to Flanders.

Speaker 4

We do have some period costs to go through as we're validating new equipment and putting in disposable things, tips and gloves and chemicals and other things we need. So that was another part of it. So you'll see the margin bounce around a little bit. And that really flows down overall to the EBITDA margin as well. But as we look forward, particularly here in the second quarter, we see that bouncing back and likely to be very consistent with some of what we saw in the Q4 of 2023.

Operator

Question comes from the line of Catherine Schulte with Baird.

Speaker 10

Hey, everyone. This is Tom Peterson on for Catherine. Thanks for taking the question. Just to start, I guess, we've heard from peers that there is perhaps a slower than normal budget early from pharma this year. I guess, did you see any of these dynamics in the quarter, particularly just any atypical phasing that you saw in the Q1?

Speaker 2

Sure. With our 2 different segments, they are different dynamics. Typically in BST, we see our high point in Q1. And that has to do, I think, mostly with calendar budget, pharma program planning and really consequentially CDMO program planning. In NAP, we did see a little bit of that.

Speaker 2

I'll hand that over to Drew specifically.

Speaker 8

Yes. I would say we saw a couple of different dynamics. It's a little tough to disentangle. I think we've seen some rationalization both among big pharma and small pharma. That said, we also saw some situations where people are continuing to push pipelines ahead and we saw a stronger funding environment in the public and the venture capital markets.

Speaker 8

So a little bit crosscurrents. I don't think in our business we see any discernible trends from that. We assume it's probably going to take a bit of time before that those funding dynamics, the strengthening in funding shows up in orders. But I guess that's how I would characterize the environment.

Speaker 10

Okay. That's helpful. And then maybe just one for Kevin on some of the cost actions and restructuring. How right size do you feel that the corporate and structure is today given some of the comments around some of the commercial focus on today's call? Should we be thinking about incremental actions in 2024 in either direction?

Speaker 10

And should we still be thinking about kind of $26,000,000 of net benefit from the cost actions here in 2024?

Speaker 4

Yes. I think absolutely. I think that the cost actions about what we're talking about $30,000,000 about 2 thirds of those tied to labor, those have all happened. So with that influx in the headcount and some of the metrics that I spoke of. And we will continue to, as we spoke of, make targeted investments in commercial.

Speaker 4

So we'll continue to see, I think, that line and R and D line particularly continue to see incremental investments throughout the course of the year. And again, I think the right way to sort of look at this as we tried to frame in last call, is if you have 200 units of cost, we weren't necessarily going from 200 units to down to 170 units. It was more like as opposed to going from 200 units to where it would naturally have been something like 240 or closer to 210. We sort of took some of that out of our run rate, but we also wanted to make sure we were still investing in R and D for innovation sake. And we talked a lot about that progress.

Speaker 4

In commercial, we talked a lot about that progress as well as in Alphazyman and Cygnus, which continue to show good momentum and good growth. So our focus was really in taking those costs specifically out of G and A and specifically about rightsizing the operations at Trialing here in the San Diego facility and then kind of also converting some of that labor and making them fungible to move over and take care of some of the increasing demand we'll be seeing that will be driven by Flanders too. So again, it's a very focused effort. We're very happy with how we've executed that and we're on track to realize all those savings that we articulate.

Operator

Your next question comes from the line of Matthew Sykes with Goldman Sachs.

Speaker 11

Hi, this is Yvie on for Matt. Thanks for taking my questions. Could you walk through the current GMP to RUO split and how you see that trending throughout this year with the new facilities coming online?

Speaker 4

Yes, I could take that. It's not something that's necessarily broken out, but I would say that when we look down into our business, particularly nucleic acid production, we see we look at it in different ways. We obviously have our business units that we look at those represent both our Alphazyme business, which continues to grow and perform well, our Glenn Research business unit, which is part of the structure, but tied more predominantly to diagnostic sequencing in some of those applications, which continues to perform extremely well. And then we have within what we brand as our trialing products, really the bifurcation between discovery and that kind of RUO business, if you will, on the research side. And then we have GMP.

Speaker 4

And certainly, as the course of the year, I would say, the discovery has been fairly steady in that it will ebb and flow a little bit, but it won't have some of the volatility that we see in GMP, meaning you have ongoing purchases, lower ticket items, more recurring purchases and a longer tail of customers there. So that's a unique dynamic and why we're managing it slightly differently. But with GMP, that's where we will see sort of the spikiness in our business as we have large bulk orders for CleanCap or as we do those GMP mRNA jobs. And certainly those are the areas as we go throughout the course of the year with the Flanders capabilities and moving into next year, we see the opportunity to grow the business. So I would say we're focused on discovery, a little less dynamic historically, And then GMP is the one that could be a lot more dynamic.

Speaker 4

And right now when we look at the quarter, the 2 within TriLink were relatively evenly split this quarter. I think that dynamic will change next quarter, even as we grow because we're aware of some of the GMP jobs and commitments that we have there as well as the uplift in the GMP clean cap orders that we already have booked for the Q2.

Speaker 2

I think that's well said. We expect the Discovery business to be much broader, diversified and like Kevin said, lower ticket item, which means probably less lumpy, which is a term you're hearing thrown around a lot this season. GMP will of course be more of the late phase pharma lumpiness. So we tend not to look at the business that way necessarily. As Kevin said, we have we operate trialing discovery and trialing GMP differently.

Speaker 2

But because GMP is so subject to those large order swings, the proportion can ebb and flow quite a bit. It's something that has to be tracked over probably longer periods.

Speaker 11

Okay, definitely. That makes sense. Thank you. And then second on the EBITDA margin, could you talk about what an exit rate might look like compared to last year? I know there's a lot of puts and takes with less COVID volume, but also taking into consideration some of the cost savings.

Speaker 11

So just thinking about like cadence, especially as we get into like Q4 and then into 2025?

Speaker 4

Yes, sure. Certainly, with the revenue being in a low mark here in the Q1 versus what we've seen, that translates into the lower EBITDA margin that we've seen and the lowest we've seen looking back certainly over the last 5 quarters. And we certainly see that growing. I think if you just look, I'll just refer to the midpoints of our guidance for simplicity, that will see us printing revenue numbers on average of around $71,000,000 for the next few quarters and EBITDA probably around on average $19,000,000 or so to get to the middle of that range. That would be 27 percent on average EBITDA margins for the next three quarters.

Speaker 4

There'll be some ebb and flow there certainly, again, tied to some of these spikes and quarterly sequential moves on Clean Cap and some of our higher margin products. But I think you'll see again those sort of on average numbers and kind of moving again with revenue. Again, as we see it right now, we see we're saying that the second quarter here will likely be up in that in the low 70s. That will probably carry a much higher margin, and we'll kind of revisit the rest of the year as we get into it. But I think as we're looking at the business right now, getting back into the type of margins we saw exiting Q4, certainly up in the 25% to 30% range is what we're looking to do.

Speaker 4

And certainly that will be tied to the revenue profile of the business particularly the NAPP segment.

Operator

Your next question comes from the line of Matt Larew with William Blair.

Speaker 6

Hey, good afternoon. First question, Trey, you talked about a litany of new products and service offerings, which sort of has been the theme of the last year. But obviously, the top line impact maybe hasn't been apparent just because of the broader headwinds your business is facing. Could you maybe help us point to 1 or multiple products you see as the or service offerings you see as the most potentially needle moving in terms of helping to inflect the top line, be it from traction you're seeing with customers, most promising funnel building, maybe where you have the most apparent right to win, just because there's so much sort of new that's going on, maybe help us focus in on what you see as most meaningful?

Speaker 2

Yes, absolutely. That's a good way to look at it actually and it sort of dovetails into the previous question about the business dynamics that are different between the discovery business, which is where those RNA, mRNA catalog products be announced here. They sit in discovery RUO versus of course GMP services where we do contract mRNA production for people, but also where GMP clean cap and other process inputs sit. I would say probably the most needle moving and most exciting over the past year. We are, I guess, about to hit the 1 year anniversary of the launch of CleanCap M6, which was an RUO product.

Speaker 2

I would say that that product exceeded our initial expectations pretty significantly. And as we just announced, taking that to GMP where we've already run an engineering batch, we're going to hit we're going to hit GMP M6 within a year of the launch of the RUO product and that's pretty exceptional. And of course, the historical participation of this company in pandemic vaccines and other things comes from the GMP reagent space. So those are definitely needle movers. So I would say that probably the most exciting and needle moving of the NPIs is a great example because it was an RUO from almost exactly a year ago and now will be a GMP going forward shortly here.

Speaker 6

Okay. Thank you. And then one for Kevin, just sort of on the cadence of G and A. You'd referenced on the last call, G and A being down about 5% for the full year. And so we modeled it down sequentially.

Speaker 6

You may have referenced some one timers, but I think just to start hitting that upper 20s EBITDA margin range, particularly the gross margins you outlined, there would seem to be that require like a significant step down sequentially in G and A in the second quarter and then beyond that. Is that still right? And just maybe remind us again on the moving pieces from Q4 to Q1 and Q1 to Q2?

Speaker 4

Yes. I think that one of the things you have to obviously carve out of there are the non EBITDA impacting items. That's certainly part of that view. So when you look at that, you have the I guess I would say the stock which is going up fairly materially this year versus last year's. And so, I think, we're going to continue to see with what we're seeing in the G and A line as far as the trends there.

Speaker 4

And so I think that that's when you peel back that we are seeing that decline and that added contribution to the overall EBITDA margins. When I look at our adjusted just G and A expense for the Q1 here versus where we were a year ago, that is down gosh, let me just look at this real quickly. It's down just under 20% year over year on the expenses that hit the EBITDA line. So I think we're very happy with the progress we're making there and have made and see that as a steady run rate to achieve that full year savings.

Operator

Your next question comes from the line of Michael Ryskin with Bank of America Securities.

Speaker 12

So I wanted to pick back up on the kind of biotech funding line of questioning. Understandably, an uptick in biotech funding isn't going to immediately become revenues for Merivai, but I'm interested in your thinking around, are you seeing this reflected in your conversations? Or how should we kind of think about the lag between an improvement in the end market and then that translating into your order book and eventually revenues?

Speaker 2

Yes. I think we touched the idea that the let's call it the sawing of that environment will be beneficial going forward. Definitely not an immediate thing, but maybe Drew, if you have some color or anonymized examples.

Speaker 8

Yes, sure. Look, I think every customer has their own journey and kind of translating through their new funding where they have achieved such into new clinical plans, putting those to work, purchasing raw material inputs or purchasing purchasing mRNA, it's going to be a variety of time. I think what we landed we expected to land for Q1 or maybe a little bit stronger, we haven't seen any kind of dramatic change as a result of the funding in aggregate, but every customer journey is maybe a little bit bespoke.

Speaker 12

Got it. Appreciate the color there. And then kind of tippening a bit, I noticed through the presentation you mentioned your openness to M and A a couple of times. Wondering if there are any areas of the portfolio that you see is particularly suited to inorganic additions. Then are you what are you seeing in terms of seller expectations in terms of regarding valuation now that the broader sector has started to catch a bit?

Speaker 2

Very insightful question. We have definitely been active and one of the tricks with all of this is that we can't really talk about it until it's official. But the one of the things I would say is we have seen a tremendous number of things that are strategically aligned. And obviously, that's what we look for first. The challenge to date has been finding strategically aligned opportunities that are also financially aligned.

Speaker 2

At the our specialty at Maravai has been scientific founder driven category leading companies. We think that's a very good niche that we fill and there's certainly plenty of opportunities to do that. But your comment is correct about expectations. This has been such a dynamic environment with the pandemic, with the pandemic fall off, with interest rates, with funding. It has been head spending to be sure.

Speaker 2

The challenge I would say for us has not been a challenge of finding strategically aligned opportunities more so financially aligned. But we continue to look for that right fit and we're definitely still very active in that area.

Operator

Your next question comes from the line of Connor McNamara with RBC Capital Markets.

Speaker 13

Hi, this is Dave Ricardo on for Connor. Thanks for taking the call. I just wanted to touch on what the step up in volume and revenue is for customers as they move up in clinical trials?

Speaker 2

Okay.

Speaker 13

For your Flanders to, I'd say, come up.

Speaker 2

Okay. Yes, I mean this comes back a little bit to the prior theme where in RUO you have PO sizes in the 5 to 6 figures, sometimes in the 7 figures. In GMP, you typically start in the figures and go into the 7 or even 8 figures, but it's completely program dependent. When you sell a GMP reagent, for example, it's simply a function of scale. But when you do a contract mRNA service under GMP, each and every program is unique, bespoke and it completely depends on yield, purity, analytical services, all sorts of litany of things.

Speaker 2

They're all custom quoted. So there's not unfortunately, if I understand your question correctly, there's not necessarily a standard expectation there. Those are big line items and they're big projects, but they're all very different.

Speaker 13

Thank you. Could you also provide some color on the impact of the Thermo Clean Cap partnership that you announced in relation to the M message?

Speaker 2

What was the last part of that, sorry?

Speaker 13

The thermal including your MCAP in there in vitrogen kits.

Speaker 2

Yes. Okay. So that's another example I would say of our wanting to make sure that we are seeding the market with our technology, whether the discovery market or the GMP market. So we that's another public license where Thermo is licensed to incorporate clean cap chemistries in their in vitro transcription kits. This is one of the many ways that developers will get mRNA in their own hands.

Speaker 2

In that case, they might have the template themselves and run the IVT process on the bench. That's an RUO only application. But that's I think just another of the broad examples of our trying to make sure that we have broad accessibility for all of our technical solutions in the market.

Operator

That concludes our Q and A session. I will now turn the conference back over to Debbie Hart.

Speaker 1

Great. Well, thank you everyone for joining us today. We'll be attending several conferences in the coming months. So I encourage you to look at our Events section of our website and hopefully we can catch up with you in person at one of those events. Feel free to connect with us with any further questions and we hope you have a great evening.

Speaker 1

Good night.

Operator

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

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Key Takeaways

  • Maravai reported $64 million in Q1 revenue—beating guidance—with $8 million of adjusted EBITDA and an adjusted loss per share of $0.02.
  • In nucleic acid production, Maravai expanded its IVT toolkit—now covering most mRNA enzymes—and launched over 20 new catalog mRNAs featuring CleanCap M6 and N1-methylpseudouridine via its CleanScript platform.
  • Key partnerships include a non-exclusive license with Lonza for CleanCap analogs in global mRNA services, a scale-up collaboration with Applied DNA for the Linea polymerase, and research alliances with five top-tier academic institutions.
  • Facility build-outs are advancing: Flanders 1 produced its first GMP small-molecule batch and is converting CleanCap M6 to GMP, while newly opened Flanders 2 provides late-phase cGMP mRNA drug substance manufacturing and has already secured Phase 2/3 work.
  • With $562 million in cash versus $532 million in debt (net cash of $30 million), Maravai reaffirmed its 2024 guidance of $265–285 million in revenue and a 23–25% adjusted EBITDA margin, while maintaining capacity for organic and inorganic growth.
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Earnings Conference Call
Maravai LifeSciences Q1 2024
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