MRVI - NASDAQ

Good afternoon, everyone. Welcome to today's Maravai LifeSciences Third Quarter 2025 Earnings Results Conference Call. [Operator Instructions] Also, today's call is being recorded. [Operator Instructions] Now at this time, I'd like to turn things over to Ms. Deb Hart, Head of Investor Relations. Ms. Hart, please go ahead, ma'am.

Good afternoon, everyone. Thanks for joining us on our third quarter 2025 earnings call. The press release and slides accompanying today's call are posted on our website and available at investors.maravai.com. During today's call, management will make forward-looking statements and refer to GAAP and non-GAAP financial measures. It's possible that actual results could differ from management's expectations. We refer you to Slide 3 for details on forward-looking statements and our use of non-GAAP financial measures. The press release provides reconciliations to the most directly comparable GAAP measures, and we also post a reconciling schedule to our investor website. 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 our Chief Executive Officer, Bernd Brust.

Good afternoon, and thank you all for joining. Let's begin with a review of our third quarter performance on Slide 5. For Q3, we reported $41.6 million in total revenue with Biologic Safety Testing generating $16.3 million, growing at 7% and Nucleic Acid Products contributing $25.4 million, declining at 53% year-over-year. Cygnus continues to perform well with strength from the U.S. and European markets. Although we experienced a decline in Q3 revenue performance from TriLink, this was in line with our expectations and driven by order timing in our GMP and CDMO businesses, segments that by nature are lumpy. Excluding COVID GMP CleanCap, we expect strong top line growth for NAP in Q4 with the majority of orders already in hand. Please turn to Slide 6. As we shared during our Q2 call in August, our immediate focus as a new management team was to get our cost structure in line and position the company for both positive adjusted EBITDA and cash flow in 2026. We have stabilized our operations and significantly reduced expenses, strengthening our balance sheet going forward. We are on track to lower our expected annualized expenses by greater than $50 million. We expect to see more than $7 million in sequential adjusted EBITDA improvement in Q4. The execution of the restructuring is largely complete and the remaining initiatives are progressing to plan. The work we have done to reset, refocus and strengthen the company, positions us to deliver attractive growth in Q4, while continuing to serve our customers with the same dedication we've had in the past. Turning to Biologics Safety Testing on Slide 7. Our sickness business continues to deliver strong recurring revenue with broad adoption across novel monoclonal antibodies, biosimilars, recombinant vaccines and all 25 approved CAR-T cell and gene therapy products, maintaining our 100% coverage in this space. We are expanding our HCP assay portfolio, including novel mass spectrometry-based assays and seeing robust demand for contract services, MockV viral clearance kits and custom assays. Q3 marks our second quarter of year-over-year growth in BST. The strength in Q3 came largely from our core markets in the Americas and Europe, which were up 8% and 17% year-over-year, respectively. We believe this growth reflects renewed focus on biologics development and manufacturing by biopharma and CDMO companies. Cygnus's position as the gold standard and thought leader with regulatory agencies and throughout the industry helps ensure customer retention, and we believe our expanding full-service offerings can fuel continued growth for our BST segment. Turning to our Nucleic Acid Products segment on Slide 8. We offer discovery consumables, GMP consumables and CDMO services for therapeutic, vaccine and diagnostics applications. TriLink's discovery market continues to be influenced by the broader macroenvironment and lower funding levels. While a portion of our discovery revenue comes from early-stage basic research, a substantial share, approximately 60% is generated from larger orders that typically reflect more advanced programs that have moved beyond early discovery into later-stage screening and preclinical development activities. We are encouraged by early signs of stability and renewed growth in these higher-value orders. In Q3, our Discovery business achieved modest sequential growth, and we are seeing strong momentum into Q4, supported by a healthy funnel and strong start in October. In TriLink GMP consumables, historically, we have presented GMP CleanCap sales related to COVID, amounting to approximately $66 million in 2024 with no projected revenue for 2025. The fourth quarter will mark our last period of negative comparison of $14.3 million. Beginning in 2026 onwards, we anticipate annual revenues of roughly $10 million to $20 million from COVID vaccines and we'll manage the business holistically, embedding COVID GMP CleanCap as part of our ongoing GMP consumables portfolio. In the third quarter, our base GMP consumables revenue declined due to the timing of CleanCap GMP orders, which typically align with customer programs advancing into next stage trials. This revenue stream traditionally has quarter-to-quarter variability. Despite lower third quarter revenue, we have strong visibility into our fourth quarter forecast and expect strong sequential and year-over-year growth in base GMP consumables. On the innovation front, we launched our ModTail technology. ModTail enhances mRNA protein expression and duration, both key for next-generation RNA medicine and is showing promising results in early trials at both established customers and internal trials. We are aggressively driving adoption through targeted marketing and customer sampling with ModTail now offered as an opt-in on every quote. We believe this innovation will help broaden our customer base, drive new customers into our ecosystem and is expected to be a future revenue driver, especially in CAR-T and oncology applications. While our ModTail works seamlessly with our CleanCap technology, there are also significant improvements seen even when using an enzymatic capping mechanism, thus opening the sales channel to non-CleanCap users. Through Q3 2025, we've already had 9 clients use our new mRNA plus ModTail services, some for multiple programs and another 14 clients have ordered our catalog ModTail products. We're also pleased with the reception of our IVT kits, which combines several of TriLink's innovative RNA discovery products to create an all-in-one solution for high-performance RNA synthesis. These kits were launched in May and although still early days, the momentum has been terrific. We've had consistent bookings growth month-over-month since launch with both existing and new customers. Importantly, these kits serve as an entry point for customers who may transition into using our GMP products over time, expanding our user base, strengthening cross-product adoption and fostering long-term relationships. Based on their early success, we plan to launch additional kits in 2026. Last quarter, I highlighted the launch of our computer-aided design and order platform, mRNA Builder. I'm pleased to report an encouraging early response. Customers are now designing and ordering mRNA constructs through our fully guided self-service workflow, enabling us to serve more clients with greater operational efficiency. Since the launch of the platform, we've seen a doubling of the number of orders placed. Customers require minimal or no direct interaction during the purchasing process and increasing our quote-to-order conversion rate to over 80%. We are working to expand the platform and to commercially launch on a larger scale, broadening our digital ecosystem. Within the NAP business, we also have our CDMO services. Please turn to Slide 9. Our CDMO capabilities set us apart, offering comprehensive support from discovery through late-stage clinical development. We are seeing increased engagement from both new and repeat customers, particularly in the cell and gene therapy market and have secured multiyear supply agreements, which enhance our revenue visibility and strengthen our long-term partnerships. Maravai is uniquely positioned for this industry, and we plan to continue to add capabilities to support our cell and gene therapy customers. The anticipated growth in this sector suggests that our CDMO business can support the mRNA market without depending solely on infectious disease vaccine manufacturing. In 2026, we are expecting an increase in the number of CDMO programs we support as well as an increase in the average batch size per build. Please turn to Slide 10. While Maravai has had challenges over the last year, my team and I have taken decisive actions to adjust our cost structure and to reinforce our foundation. Our core technologies, deep customer relationships and strong end market exposure remain powerful assets that position us for growth in Q4 into 2026 and beyond. What I would like to leave you with today is that I continue to be energized by the opportunity to lead Maravai. Being in the CEO seat for 5 months now, I, along with my leadership team, have developed our strategy based on 3 fundamental pillars for results: operational excellence, revenue growth and of course, return to positive adjusted EBITDA in 2026. We are operating with greater financial discipline, prioritizing cash generation and aligning investments with clear ROI. With a strong balance sheet and healthy liquidity, we have the flexibility to invest in the highest return opportunities, while maintaining profitability improvement as a top priority. I have the utmost confidence in our future. Now I'd like to turn the call over to Raj Asarpota, our CFO, for more details on the quarter and our financial guidance.

Thank you, Bernd. Let's turn to the Q3 financial results on Slide 12. Revenue for the quarter was $41.6 million compared to $69 million in Q3 2024. Excluding revenue for COVID GMP CleanCap, base revenue in Q3 2024 was $50.8 million. For the base business, which excludes GMP CleanCap orders, primarily related to COVID vaccine programs, was down 18% for Q3 versus 2024. Our Nucleic Acid Products or NAP segment had revenue of $25.4 million in Q3. The Biologics Safety Testing segment, or BST revenue, was $16.3 million in the third quarter. I will discuss segment results a little later in the call. Revenues by customer type in Q3 were 27% biopharma, 32% Life Sciences and Diagnostics, 4% academia, 8% CRO, CMO, CDMO and 29% through distributors. Revenue by geography was 60% North America, 19% EMEA, 12% Asia Pacific, excluding China, 8% in China and 1% from Latin and Central America. Turning to Slide 13. Our GAAP net loss before non-controlling interest was $45.1 million for the third quarter of 2025. This compares to a GAAP net loss before non-controlling interest of $172.5 million for the comparable third quarter of 2024. Note that in Q3 2024, there was a goodwill impairment charge of $154.2 million. Adjusted EBITDA, a non-GAAP measure, was a negative $10.8 million for Q3 2025 compared to a positive $16.2 million for Q3 2024. Moving to Slide 14 and EPS. Basic and diluted EPS for the third quarter was a loss of $0.18 per share compared to a loss of $0.68 per share in the third quarter of 2024. Adjusted EPS in Q3 2025 was a loss of $0.08 compared to a loss of $0.01 in Q3 2024. Advancing to the balance sheet, cash flow and other financial metrics on Slide 15. We ended the quarter with $243.6 million in cash and $295.6 million in long-term debt. For Q3 2025, cash used in operations was $15.2 million. This includes a $1.6 million impact from restructuring expenses. Depreciation and amortization was $13.2 million and interest expense net of interest income was $4 million in the quarter. Stock-based compensation, a non-cash charge was $9.1 million for the quarter. Next to Slide 16 and the discussion of segment performance. The NAP segment had revenue of $25.4 million in Q3, 61% of total revenue. Base NAP business, excluding GMP COVID CleanCap was down 29% year-over-year. The year-over-year revenue decline in NAP was driven by the following. First, the timing of GMP product orders we saw in Q3 2024 not recurring in Q3 of this year. As Bernd mentioned, this part of the business can receive large orders as customer programs advance in clinical trials, and we already have strong order velocity for GMP consumables in Q4 and into 2026. Second, CDMO build from Q3 last year did not repeat in Q3 of 2025. We have a strong funnel for contracted CDMO services revenue, some of which is expected to be recognized in Q4. And third, discovery continues to be impacted by the current funding environment and other macro conditions. While discovery was down year-over-year, we did see growth in Q3 over Q2 for our discovery consumables, and we've seen a strong start to Q4. Bernd discussed some of the trends we are seeing in discovery, particularly in the screening and preclinical part of the business that is less impacted by funding dynamics. Adjusted EBITDA for NAP was negative $7.9 million in Q3. We view Q3 as a low bar and see significant growth in Q4 for NAP. BST grew 7% year-over-year to $16.3 million in the third quarter or 39% of total revenue. The strong year-over-year growth was driven by demand for wholesale protein kits and quantification services and increasing adoption of MockV viral clearance products. In BST, we saw strength in the U.S. and European markets, while China was down. Adjusted EBITDA for BST was $10.5 million for an adjusted EBITDA margin of 64.8%. We incurred an increase in cost of goods sold in Q3 in BST due to a change in our labor and overhead capitalization methodology tied to team realignments, which temporarily reduced EBITDA margins, but creates greater operational efficiency and long-term margin improvements. Corporate shared service expenses impacting adjusted EBITDA totaled $13.4 million in the third quarter. These services include centralized functions such as human resources, finance and accounting, legal, information technology and the incremental expenses associated with being a public company. This is another large pocket of cost within the organization that we have reduced with the cost actions announced last quarter. We are on track for the expected greater than $50 million annualized reduction in expenses and expect that we will have reduced expenses by more than $10 million in the second half of 2025. The strategic realignment and cost reduction initiatives are proceeding according to plan and the foundation focused on executional rigor has been established with the aim of expanding margins. We expect more than $7 million in sequential adjusted EBITDA improvements in Q4. Now, let's address our guidance for 2025 on Slide 17. As you likely recall, as a new leadership team, we made the decision to withdraw the company's prior guidance range to give us a chance to complete a full business review. That process is now complete. We're also confident that we have a disciplined forecasting process in place with cross-functional engagement embedded in monthly planning and visibility improving across our business units. We anticipate closing 2025 with revenue of approximately $185 million. This implies Q4 growth of 18% over the third quarter and excluding GMP COVID CleanCap, Q4 base business growth of 16% year-over-year. We also expect our 2025 adjusted EBITDA loss to be roughly $35 million for the year, which would mean an adjusted EBITDA loss of $3.5 million in Q4. In closing, I'm encouraged by the steps we have already taken and continue to position Maravai for long-term success. Our financial discipline is evident in our ongoing efforts to align investments with strategic priorities and to optimize operational execution across all segments. We're committed to driving efficiencies, enhancing our cost structure and ensuring that every dollar invested yields measurable value for our shareholders. With clear financial targets and a road map for returning to revenue growth and expected positive adjusted EBITDA in 2026, I'm confident in the trajectory of our business. We will offer detailed guidance for 2026 during our fourth quarter call. The progress we have made so far, combined with our operational rigor, sets the stage for sustainable growth and value creation in the quarters and years ahead. I'm optimistic about what lies ahead for Maravai. I'll now turn the call back to the operator to begin the Q&A session.

[Operator Instructions] We'll go first this afternoon to Justin Bowers with Deutsche Bank.

So just curious on the anticipated $10 million to $20 million of revenue contribution in 2026 from CleanCap, do you have commitments for those orders? Or is that more around just conversations that you're having with the customer and for customers and indications there?

Justin, this is Bernd. It's a combination of 2. We have some orders in hand and others tied to customer discussions. That $10 million to $20 million is a good number.

Okay. And then in terms of the cost savings that you have running through in the fourth quarter and next year as well, is that coming out of the COGS line, SG&A? Sort of what's the split, and the thinking there?

Yes, I'll take that. This is Raj. So as we've communicated previously, the $50 million plus comes through a bunch of different categories. We expect about 40% to 50% of those kind of realizing from labor cost reductions, another 15% to 20% on facilities, 15% to 20% on CapEx and then another 15% to 20% on other controllable spend. And if you look at the split between COGS and OpEx, it's roughly 50-50.

We go next now to Matt Larew of William Blair.

This is [ Jake Kim ] on for Matt. Just wanted to ask about that strategic review. It sounds like it's largely been completed, which is -- it's good to hear. So maybe just more high level on the first part. Wondering if you could just talk a little bit about your key findings from the review? What was the most surprising or maybe stuck out to you? And what we say like the actual outcome of the review is? It sounds like the adjusted EBITDA and free cash flow positive targets for '26 are still intact. But maybe what are the sensitivities to that time line to the target and visibility into achieving them, both on sooner than expected, but also potentially then being pushed out?

Let me maybe take the high-level side here and then hand it over to you. I think specifically to the findings, so we've been here for, respectively, 4, 5 months now or so together. And the choices we made to restructure the business and obviously impact quite a few people's careers here is tough, but I think ultimately went as smooth as it could have gone. So I think the finding here for sure has been the company was probably structured a little too heavily for what its base is. And so I think ultimately, what we have experienced here is a business today that runs much better. I think we have a leadership team that's highly engaged and focused on building this business to where it needs to be again. But ultimately, I think the impact on the business with the changes we've made have been minimal. And so I think findings of being heavily structured in areas where we shouldn't have been. Those are now downsized has worked out great for the business.

Great. And then just a follow-up. I wanted to ask about the BST performance in the quarter. Good to see this business now return to growth for 2 consecutive quarters now. I imagine a lot of that has to be driven by like improving biotech funding backdrop. But really wanted to unpack where you're seeing strength here on a regional perspective? I think you mentioned strength in the U.S. and Europe, while China remains weak. We've heard from peers in this reporting cycle, China seems like it's starting to recover. So just wondering what you're seeing there and maybe what's embedded in your outlook?

I think you're spot on with what you said. I mean I think in our last earnings call, there was some question whether strength was coming because of some related tariffs in China and people stocking up and that clearly is not the case here. It's nice to see strength coming back in the core markets of the U.S. and Europe. I'm in agreement with you. I think it's starting to show improvement on funding. We'll see how the continuing quarters will be. But certainly, we're optimistic about where this business is heading.

We'll go next now to Doug Schenkel of Wolfe Research.

This is Madeline Mollman on for Doug Schenkel. I just wanted to touch on the gross margin. Gross margin has been in the teens so far this year. I know you talked about taking about $25 million of the $50 million out of the COGS line. How should we think about the gross margin expansion in Q4 and then into 2026, especially if you do get that contribution from the COVID CleanCap, which is typically one of your higher-margin products?

Yes. It's a good question. And I think as we feel -- as we kind of look ahead into Q4, you can definitely kind of think about modeling improvements with the cost reductions we've announced. And we'll give more specific guidance in our fourth quarter call, but there will be improvement in gross margin, primarily related to product mix. So like you said, as we start to get more GMP orders in, that gross margin rate will improve.

Great. And then just one clarification. You talked last quarter about some of the like high-volume CleanCap orders that could come in 2026. Is that $10 million to $20 million of COVID orders the same as what you mentioned last quarter? Or would this be on top of that?

That is the same.

We go next now to Catherine Schulte of Baird.

This is Tom Peterson on for Catherine. Just want to maybe dig in on the TriLink funnel and order velocity that you spoke to. You mentioned orders in hand thus far kind of supporting this outlook. So I guess, is this just kind of typical order timing or lumpiness? Or do you think there's something else that's really contributing to the sequential improvement?

I think it's a combination of both again here. When you look at Q3, it's hard to feel great, obviously, about the revenues that happened in the GMP business there, but nothing was unexpected as far as what our forecast were from our customers. So I think part of this is just purely timing that we normally experience in this part of our business. But I do think we're seeing some positive direction of seeing incremental orders coming in. We've seen a number of larger orders coming through our system in the last couple of months. And all of that is pretty much tied to either screening kind of activities or sort of earlier-stage clinical trial work. So it's nice to see some of that movement happening.

Great. And then maybe just wanted to get a few more comments on the discovery funding environment, in particular. You mentioned the macro and kind of the challenging funding environment that we've seen. I guess what are you hearing from customers today? We maybe heard a little bit more positive developments given some of the policy outcomes around [ MFN ] and things like that. So I guess what are you hearing from this customer set?

Yes. I think it's becoming more neutral, but I don't think it's great yet. I think the important part in our business, when you think about discovery, we look at the business kind of in 2 segments, right? Orders over $25,000, which we don't consider Discovery with more screening and clinical trial kind of activity that's still using RUO consumables. That's about 60% of our revenues in that segment, and we feel really good about what's happening in that segment. And if you look at orders under $25,000 in that Discovery segment, that's -- I still think fairly tough. However, if you think that's primarily academic for us, that's less than 4% of our revenues today. So we're fairly well shielded from what's happening in that market. So do I think you're hearing some positive things? Yes. Do I think Maravai as a company is at this point very well protected against some of that funding challenge? I think we're in a good place.

We'll go next now to Subbu Nambi with Guggenheim.

This is [ Ricky ] on for Subbu. Maybe just if you could provide a little bit of color on the confidence you had in the ex-COVID GMP CleanCap in 4Q and then also in 2026? And maybe just any changes to your expectations or your outlook for excluding COVID, that GMP business longer term?

Well, certainly, on Q4, we have a high level of confidence and most of these orders are in hand. And we have 2 months left in the year. October was strong. So I think we're in a good place for what the Q4 forecast is. I think macro level for 2026, we feel good. And if you look at the number of orders in hand today for 2026 versus similar orders in 2024 for 2025, we're materially greater now than we were last year. So I think all those indicators show the right direction that we have to take here. Raj, I'm not sure if there's more specific numbers you want to add, but I'd leave it with that.

No, I think like Bernd said, we are already seeing a lot of good visibility through our customer forecast. We've got binding purchase commitments. We've got multiyear supply agreements, and that visibility gives us really kind of strong confidence not just in Q4, but as we kind of look at the growth trajectory for '26, we feel pretty good about it.

That's helpful. And then maybe just on that same topic, the visibility you have, is there any differences geographically that you'd speak to? You already talked a little bit about some of the different customer sizes and end markets, but just geographically speaking, that visibility [ and thing ]?

I think we should not give guidance on that. I think it's -- obviously, we're seeing good strength outside the U.S. at the moment, but I think there's some nice movement happening here as well. I wouldn't go into specifics on that at this point.

We'll go next now to Nathan Bolanos with UBS.

Obviously, there's a lot of moving pieces, but do you have any initial thoughts on what a long-term -- mid to long-term normalized growth rate for the Nucleic Acid segment could be?

Difficult question to answer. I think we continue to feel good about growing in line with what our market peers are saying in their various earnings calls. Now do I think that mRNA specifically and our weighting toward mRNA gives you some material upside depending on what happens with so many of the clinical trials that are going on. Yes, there's upside. I think whether that takes place and when that takes place is hard to judge. It's very much tied to how these trials are moving forward. But if you put a high level of confidence in that mRNA therapeutics and a very bright future and our position within that, you have to kind of assume that greater growth will come. How to truly kind of quantify an exact number is very hard to do at this stage.

[Operator Instructions] We'll go next now to Matt Stanton with Jefferies.

Maybe going back over to Cygnus. I think year-to-date growth is kind of tracking mid-single-digits. Just talk about kind of durability and visibility returning here? Any pockets that are still lagging and maybe we don't go back to the mid-teens we saw historically, but is there a pathway for this to get kind of towards more bioprocessing consumable type growth? And then I know it's still very small today, but just any more color to share on MockV and the growth there? And then just more broadly, the potential opportunity within the viral clearance market for that product, which seems to be getting nice traction.

Raj, you want take that?

Yes. Sure. For Cygnus, if you look at the broad portfolio, our wholesale protein kits, that's kind of like our gold standard. That's been growing at -- that grew 7% in the quarter, and it kind of demonstrates our position with customers who remain loyal to us. And then to your question around MockV, yes, that continues to grow at a pretty rapid clip due to, again, industry adoption and confidence in the product. So we're seeing really good traction there as well. And then even on HCP quantification services, we are continuing to grow there due to repeat customers and our focus on tactical programs to kind of engage new accounts. And then just across -- if you look at the different geographies, APAC was strong, and it's been at 18% year-over-year this quarter. 8% of that growth came from the Americas, 12% in APAC and 17% in Europe. So all in all, the whole portfolio is holding pretty strong.

I think we're seeing the biggest weakness is China still, right?

Yes.

Or was still down? So when we say Asia, we kind of exclude China?

Exclude China. Yes, China was down 12%.

Okay. And then, I appreciate all the color on some of the new products with ModTail, the IVT kit. It sounds like there's more coming in the mRNA builder. Maybe just talk about the pipeline of innovation more broadly? It feels like you're taking maybe more of a refined approach for less numbers of products, but maybe those that are more impactful or more impactful sooner. And then as we try to start to think about what that can mean for '26 and beyond, any of these, can they move the needle on their own? Or if we kind of package some of the meaningful launches up together, is there a chance that those could add a couple of points to growth or something next year as you continue to get traction there?

We have our Chief Scientific Officer, Chanfeng

Yes, sure. This is Chanfeng

Specifically, right, to our strategic direction of do we think new products in our portfolio will drive growth beyond just CleanCap in this segment? The answer is yes. I mean there's no question that our goal is to continue to innovate consumables in the discovery world that we then take into GMP manufacturing and then have those used, obviously, in various clinical trials and commercialization eventually. I think when you look at our ModTail product, amazing opportunity to be not just in products that use CleanCap, but also enzymatic capping. We have an enzymes business that we're trying to bring into a GMP world. We're finishing our GMP facility in Florida up on that, I think, in the next 3 months or so. And there'll be a variety of other consumables over the next years to come that we will bring forward into GMP manufacturing. So I think that the overall depth of our pipeline through R&D is incredible with some really outstanding potential high flyers there as well like ModTail.

And ladies and gentlemen, it appears we have no further questions today. Mr. Brust, I'd like to turn things back to you, sir, for any closing comments.

Well, I appreciate everybody dialing in again. Q3, obviously, from a growth perspective, not something that we can all feel great about, but expected within [ mind ] of what we felt as a management team. I truly believe that the vast majority of this is due to timing, and we're seeing that materialize in Q4 here. So we appreciate your continued support and are excited to bring Q4 to closure here and have the next call where we can talk about all that having happened in a great 2026. So I appreciate your support, and we look forward to speaking with you again in the next 3 months.