Maravai LifeSciences - Q3 2023

Transcript

Operator (participant)

Ladies and gentlemen, thank you for standing by. My name is Demi, and I will be your conference operator today. At this time, I would like to welcome everyone to the third quarter 2023 Maravai LifeSciences Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number 1 on your telephone keypad. If you would like to withdraw your question again, press the star 1. I would now like to turn the conference over to Miss Deb Hart. Please go ahead.

Deb Hart (Senior Director of Investor Relations)

Good afternoon, everyone. Thanks for joining us on our third quarter 2023 earnings call. Our press release and the slides that accompany today's call are posted on our website and are available at investors.maravai.com. As you can see on the agenda on slide 2, joining me today are Trey Martin, Chief Executive Officer, and Kevin Herde, Chief Financial Officer. Drew Burch, President of Nucleic Acid Production, and Becky Buzzeo, our Executive Vice President and Chief Commercial Officer, will join the call for the question and answer session following our prepared remarks. We remind you management will make forward-looking statements, and we refer you to GAAP and non-GAAP financial measures during today's call. It is possible that actual results could differ from management's expectations. We refer you to slide 3 for more details on forward-looking statements and our use of non-GAAP financial measures.

Our just-issued press release provides reconciliations to the most directly comparable GAAP measures. 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.

Trey Martin (CEO)

Thank you, Deb, and good afternoon, everyone. We appreciate having you join us for our call today. Let me give a quick recap of the third quarter, provide some color on the cost-cutting initiatives we announced today, and highlight a few business updates before turning the call over to Kevin. Let's start with our third quarter results on slide 5. Today, we reported $67 million in revenue for the quarter, $12 million in total Adjusted EBITDA, and a loss of $0.01 in adjusted fully diluted EPS for the quarter. Q3 results were below our expectations, with persistent macroeconomic and industry-specific conditions impacting the top line. As we mentioned during our last quarterly update, and as referenced by many of our peers, we've seen continued softness as customers adjust their spending priorities in the wake of broader economic uncertainty and lower levels of venture and private equity-backed investment.

As a result, key customers continue to focus on capital conservation efforts, which has constrained research and development budgets. This continues to result in a longer decision-making process, causing customers to strategically prioritize and stage their programs. We are not seeing signs of near-term recovery that we expected when we provided prior guidance and expect those trends to persist at least through the end of 2023. Unfortunately, this has been a consistent theme throughout our industry. Our nucleic acid production segment had revenue of $51 million in Q3. This includes an estimated $36 million of base nucleic acid production revenue. The biologics safety testing revenue was $16 million in the third quarter. Turning to slide 6.

As you're all aware, Maravai grew at an exceptional rate during the pandemic as we scaled the manufacturing of CleanCap to unprecedented quantities for mRNA-based COVID-19 vaccines in the global pandemic response. We rose to serve a critical global need and are immensely proud of our accomplishments in that regard. During this period, we were also able to significantly scale our GMP capabilities to build four new facilities, to increase R&D and commercial investments, and to acquire the MyChem and Alphazyme businesses. As we evolve Maravai post-pandemic, industry needs have changed. Upon taking over as CEO at the end of July, the leadership team and I have taken a hard look at our requirements moving forward. The actions we announce today will enable us to rebalance the organization by significantly reducing labor and discretionary costs and to focus on key strategic areas of investment to accelerate long-term and sustainable growth.

We've made several difficult decisions, including resizing and reorganizing many teams throughout the company, to ensure we're serving our customers' needs in the most nimble and efficient ways possible. Please refer to slide 7 for details on the restructuring initiative. We are eliminating approximately 100 positions and making significant reductions to other non-labor expense areas to enable more efficient operations while continuing to support investment in our high-growth focus areas. We are targeting at least $30 million in annualized cost reductions to be realized over the course of 2024 from these actions.... It is difficult to say goodbye to the many talented and committed colleagues who were integral to our success through the pandemic, and I want to thank them for their many contributions.

We will actively support them as they identify their next opportunities, and we look forward to what they will achieve as they bring their experience from Maravai to their next roles. Let's move to Slide 8 to provide more color on the organization shape moving forward. As we resize the organization, we are streamlining and clarifying our organizational structure, roles, and responsibilities to support our strategy, enable sustainable growth, and better serve our customers. Maravai has a strong reputation of making smart acquisitions, and each of our company brands have a long history of being best in class. Customers rely on TriLink, Cygnus, Glen Research, and Alphazyme to support their scientific endeavors. Moving forward, operating divisions have been redefined and renamed to reinforce our strong brands, where we've specialized expertise, insight, and experience needed by our customers to advance their work.

In our Nucleic Acid Production segment, or NAP, we now have four business units, TriLink Discovery, TriLink GMP, Glen Research, and Alphazyme. Drew Burch has been promoted to the role of President for the Nucleic Acid Production segment. Each business unit within the NAP segment will be led by a general manager, who will drive focus around developing solutions that meet customer needs at the appropriate stage of their development. Our TriLink Discovery and TriLink GMP business units are now better positioned to respond to those different needs. Diving into the different needs of our customers, the TriLink Discovery business unit will be focused on working with customers at the front end of the funnel. TriLink Discovery will include all research use only, or RUO, products and services, including all reagents, the MyChem custom chemistry business, and mRNA manufacturing for screening and target discovery.

This is where the majority of our TriLink customers are today, in the discovery and preclinical position. Our clients typically start working with us by purchasing research use only grade mRNA or reagents. Many customers start with us in discovery before they have identified their targets. With these inputs, they are screening, developing, scaling up their processes, and overcoming development challenges. They want to get to market faster with the best possible candidates. They need rapid turnaround and would like to run larger screens at smaller scales. Once our customers have refined their targets and selected lead candidates, that is when TriLink GMP can step in seamlessly and help them progress through their clinical phases. TriLink GMP products and services are extremely important and highlight how we are partnering with customers throughout their journey into late phase GMP manufacturing.

We ensure that RUO-grade material provided in discovery can translate right to our GMP suites, including the new Flanders One and Two facilities. Our TriLink GMP includes GMP CleanCap analogs, GMP NTPs, analytical services, and GMP mRNA production services. Our biologics safety testing segment still comprises Cygnus Technologies and includes the MockV brand. Cygnus continues to be led by Executive Vice President Christine Dolan. We believe these changes better define roles and responsibilities for our leadership teams, for decision-making, agility, and accountability for business success. Moving to Slide 9. Our commercial team, led by our Chief Commercial Officer, Becky Buzzeo, is evolving to ensure they are a comprehensive strategic organization that can provide critical functional and system support across all businesses.

Our traditional founder-based acquisitions are generally product and technology-led and do not have mature commercial organizations or funnel systems, so we expect our new commercial organization to accelerate growth and increase visibility. This consolidated commercial engine will provide key enabling resources and tools to all of the Maravai businesses. Becky oversaw the genesis of TriLink GMP, formerly referred to as Nucleic Acid Services, and helped recruit its General Manager, Kevin Lynch. I want to thank her for pulling double duty over the past year, and now this new structure will allow her to focus solely on sales and commercial execution. We will also continue to invest in our unique analytical capabilities. We have launched TriLink's Analytical Sciences Center of Excellence, a centralized hub for advancing testing of nucleic acids to simplify mRNA drug substance characterization and accelerate critical therapeutic development.

Leaning on decades of technical expertise, TriLink continues to lead the market with mRNA-specific analytical services, having developed and qualified 10 types of unique methods for the characterization of mRNA, covering 40 various constructs. With this expansion, the Center of Excellence builds upon TriLink's comprehensive method development for construct-specific assays and has added new instrumentation to enable NMR, next-gen sequencing, and lipid nanoparticle characterization. The Center of Excellence will continue to be responsible for developing cutting-edge analytical methodologies, including mRNA fingerprinting and sequencing. We believe these changes better reflect our core strengths, highlight our best-in-class brands, and support the different RUO and GMP needs of our customers, and enable all of our teams to work effectively and grow sustainably.

Moving into our future growth on slide 10, we see many opportunities ahead, and as we outlined at our Investor R&D Day in September, we have identified a path over the 5-year term to greater than $700 million in organic revenue. We will continue to focus on driving improvements to regain our industry-leading Adjusted EBITDA margin, and we believe the cost realignment initiatives we are taking now will allow us to realize that goal even at today's volumes. Our partnership agreements continue to expand. We entered into 5 new agreements in the third quarter, 2 for new kits, 1 clinical licensing agreement, and 2 CDMO enablement agreements. On slide 11, we highlight a few of these agreements. Our newly signed partnership agreement with Thermo Fisher has CleanCap incorporated into their bench-scale in vitro gene messenger machine in vitro transcription kits.

For those of you not familiar with these kits, the products are used by many researchers for in vitro transcription of RNA synthesis for a variety of purposes, including in vitro functional studies, labeling and tagging, small animal studies, and therapeutics development. These types of partnerships allow Maravai to expand our product and technology reach and get into more customer workflows early, to partner from discovery through commercialization. We also signed a clinical license agreement with Precision Biosciences for them to utilize GMP inputs in their mRNA ARCUS genome editing platform. In vivo gene editing has the potential to permanently cure genetic diseases. ARCUS is a precise and versatile genome editing technology with the distinct potential to insert, excise, or eliminate DNA in a broad spectrum of genetic diseases.

In late September, we entered into a non-exclusive supply agreement for several of our CleanCap analogs to be used in the Elixirgen Scientific Japan Incorporated mRNA development and manufacturing services for preclinical through Phase Three programs, including CleanCap M6, CleanCap AG, and CleanCap AG 3'OMe. This agreement aligns with our objective to enable greater access worldwide to all CleanCap mRNA tech, technologies. In addition, we also renewed a multi-year supply agreement with Intellia Therapeutics, a pioneering genome editing company. This strategic collaboration ensures the consistent provision of cap analogs and other reagents, and strengthens our partnership devoted to advancing the development of mRNA-based solutions in gene editing. We, along with Intellia, recognize the transformative potential of mRNA technologies in gene editing, and are resolute in our joint endeavor for groundbreaking innovations.

By combining our expertise in nucleic acid-based products with Intellia's groundbreaking genome editing capabilities, we are poised to make significant strides in shaping the future of medicine and bettering global human health. Moving to slide 12, Maravai's innovation and people continue to receive recognition. In this quarter, we were honored with several awards. Cygnus Technologies received a 2023 R&D 100 award from R&D World Magazine in the analytical test category for the MockV RVLP Kit. The MockV RVLP Kit enables bioprocess scientists to determine retrovirus-like particle, or RVLP, removal during biopharmaceutical manufacturing in Chinese hamster ovary, or CHO, cell lines.

By using the MockV RVLP Kit, scientists can gain actionable insight into retroviral clearance whenever they wish from their own lab bench, rather than requiring the use of a contract research organization, and do their own testing at a fraction of the cost associated with prior viral clearance studies. CleanCap M6, our next generation cap analog, received the 2023 Pharma Innovations Award from Pharma Manufacturing. We spoke about M6 during our last conference call and also highlighted its benefits during our R&D Day. But to suffice to say, we are really excited by the product and expect M6 to help developers and researchers maximize the impact of their mRNA programs while reducing overall manufacturing costs, ultimately bringing life-changing medicines to the market faster.

Drew Burch, who leads our nucleic acid production segment, was named to the San Diego Business Journal's 2023 list of Leaders of Influence in Life Sciences. Our Chief Innovation Officer, Dr. Kate Broderick, was named to the 2023 PharmaVoice 100 list, which recognizes the most inspiring leaders in the life sciences. We couldn't be more proud of Drew and Kate and their accomplishments, and for the industry's recognition of our innovative products. Turning to slide 13, as we look ahead to the completion of 2023 and prepare for 2024, we believe we have the right technologies and are in the right markets to achieve long-term growth. We remain focused on growing our base business across all business units and on expanding margins through significant operating leverage.

I remain excited about our future, our capabilities, and what we can achieve together with the mission to make a meaningful impact improving human health through the next generation of medicines. I'm confident that with the realignment of our businesses, we have the team, the organizational structures, technologies, and talent to deliver on our long-term objectives. As we close out the third quarter of the year, we remain focused on expanding our product portfolio, advancing our market leadership in the mRNA space, and continuing to strategically invest in innovative R&D and our commercial operations to support our base business growth. Our revised outlook for 2023, which Kevin will discuss in greater detail in a moment, considers the Q3 results and more modest expectations for the fourth quarter, due mainly to the broader market headwinds previously discussed.

I'll now ask Kevin to provide the details on our third quarter performance and our updated guidance. Kevin?

Kevin Herde (CFO)

Thank you, Trey, and good afternoon, everyone. Starting on slide 15. As per our press release this afternoon, our Q3 2023 revenues were $67 million, below our expectations for the quarter, as the ongoing macro and industry-specific softness continues to pressure the base business across both segments. As for earnings per share, both our GAAP-based basic and diluted EPS were at $0.05 per share loss, while adjusted fully diluted EPS was a $0.01 per share loss for the quarter. Our GAAP-based net loss before the amount attributable to non-controlling interests, was $15.1 million for the third quarter of 2023. Adjusted EBITDA, a non-GAAP measure, was $11.9 million for Q3, up from $9.1 million in the most recently completed second quarter of 2023. Our adjusted EBITDA margin was 18% in the third quarter.

For the first nine months of 2023, our adjusted EBITDA, a non-GAAP measure, was $44.8 million, resulting in an adjusted EBITDA margin of 21%. As discussed in the last quarter, we remain focused on balancing our investment in our facilities and our labor to best position us for the future, while also actively managing our expense structure to address our current revenue outlook. As we continue to see the soft market conditions, we decided it was necessary to realign our cost structure more aggressively to the current demand environment. As Trey previously covered, today, we announced a structured initiative that is targeting at least a $30 million reduction in our annualized spend based on recent expense levels.

These decisions are never easy, but we feel reflect a necessary adjustment to address the broader business pressure we've all been faced with in 2023 and heading into 2024. We will be actively reducing our labor force by approximately 15%, or about 100 employees, primarily in the nucleic acid production operations areas and in our supporting general and administrative functions. This reduction yields roughly $23 million in lower labor expenses that will be realized in 2024. In addition to these reductions, we've identified another $7 million in non-labor expense reductions to achieve a minimum of $30 million in total annualized cost savings.

We believe these cost reductions help to align our cost structure to the current environment and are prudent actions as we await the broader market conditions to improve and a return to revenue growth over time that we are confident in, given the markets we serve and the strength and quality of our technology, products, and services. Now let's turn to slide 16. We ended Q3 with $580 million in cash, a level flat to the end of the second quarter. Gross debt, which has a term until late 2027, is at $534 million. Our Adjusted Free Cash Flow for the quarter was $0.4 million. Adjusted Free Cash Flow is a non-GAAP measure that we define as Adjusted EBITDA less capital expenditures.

The free cash flow in the quarter reflected our Adjusted EBITDA less net capital expenditures of $11.5 million, tied to the ongoing outfitting of our nucleic acid production GMP facilities at our Flanders location in San Diego. Now turning to slide 17. I'll now provide some more insights into our business segment financial performance for the quarter. The nucleic acid production business revenues were $51 million in the third quarter, down slightly from the $53 million for the second quarter. Nucleic acid production represented 77% of the company's total revenue in the quarter and generated $17 million in Adjusted EBITDA in the quarter, a segment margin of 32%. On a year-to-date basis, Adjusted EBITDA for the segment was $59 million, a margin of 35% on the nine-month revenues of $166 million.

Included in the results of the Nucleic Acid Production segment for the third quarter is our estimate of CleanCap revenues from our large COVID-19 vaccine customers of $15 million, consistent with our previously discussed expectations for the quarter. Our biologics safety testing business revenues were $16 million in the third quarter, contributing 23% of our total revenues. Our biologics safety testing business contributed $11 million of adjusted EBITDA in the quarter, a margin of 72%. For the first nine months of 2023, our BST segment recorded adjusted EBITDA of $35 million on revenues of $49 million, a 72% adjusted EBITDA margin. Corporate expenses that are not included in the segment adjusted EBITDA totals I just spoke, were $16 million in the quarter, in line with recent averages. Now turning to slide 18, and our updated financial guidance for 2023.

We are lowering our expected range of total revenues for 2023 to between $275 million-$285 million at the midpoint. This is slightly more than a $30 million reduction in revenues for the year.... This is disappointing given the reduction in the full-year 2023 guidance from our last quarter call, but reflects our view that we are a little less optimistic about signs of near-term recovery in the broader markets. We expect our base business to remain around the recent quarterly levels in Q4. To break this down a little further, on the top line, we see the nucleic acid production segment at around $213 million-$221 million, which includes an estimate of $61 million in CleanCap sales for COVID-related vaccine demand.

As you recall, on our prior call, we had stated we had $65 million in CleanCap POs for the year and that those POs all remain. However, one customer has communicated that they anticipated using about half of their orders to support non-COVID programs that are advancing in clinical trials. Thus, we have adjusted our estimate for the fiscal year down $4 million to best reflect what we understand to be our customer's COVID vaccine-specific demand for CleanCap. As we have discussed previously, our CleanCap franchise has multiple chemical analogues, which are not target-specific, and thus can be used across indications by our end customers. We feel this dynamic likely extended the usage of existing inventory by our customers across their mRNA programs, thus further complicating the assessment of end market demand and future large volume CleanCap visibility.

Now, removing the $61 million estimated COVID demand, our base NAP segment is estimated about $156 million in projected revenues for fiscal year 2023 at the midpoint. This reflects a decline of roughly 27% from 2022 levels. We expect our biologics safety testing revenues this year to be about $62 million-$64 million, shifting slightly lower than our previous estimate of $65 million-$70 million for 2023. The business continues to see the leveling of demand in the $15 million-$18 million per quarter ranges that we have seen since Q2 of 2022, and we've also seen fourth quarter levels dip a little bit historically, tied to CDMO manufacturing cycles.

Based on this updated full-year guidance and the 9 months that are in the books, the resulting expectations for the fourth quarter are for total revenues of between $60 million and $70 million, with the NAP segment at around $51 million at the midpoint of our range, including an estimate of $18 million of CleanCap COVID vaccine revenues, and our BST segment to be around $14 million or so at the midpoint of our range for Q4. Due to the lower revenue expectations for 2023, we are updating our estimated earnings metrics. We now anticipate adjusted fully diluted EPS in the range of a $0.01 loss to a $0.01 per share in earnings, and our adjusted EBITDA to be between $55 million and $60 million, an adjusted EBITDA margin of about 20%-21% on our updated revenue guidance.

Additionally, we expect the following financial expectations as listed on slide 19. Interest expense and net of interest income, between $16 million and $18 million. Depreciation and amortization, between $40 million and $42 million. Stock-based compensation, which we show as a reconciling item from GAAP to non-GAAP EBITDA, to be between $34 million and $36 million. This also includes an as-if fully converted share count of about 252 million shares and an adjusted effective tax rate of about 24%. Now, before I turn it back over to Trey, I want to mention that due to the limited 2024 demand visibility from our larger customers, combined with the ongoing work surrounding our cost realignment initiative, we do not yet have the level of confidence to provide initial guidance for next year as we have historically done on our Q3 call.

We believe it prudent to focus on closing out the current year, executing our cost reduction work, and continuing to work with our customers to understand their 2024 needs. We anticipate providing 2024 guidance in the early part of next year. I will now turn the call back over to Trey. Trey?

Trey Martin (CEO)

Thanks, Kevin. So to wrap up our prepared remarks on slide 21, we believe the cost-cutting initiatives we announced, while difficult, position us well for the future. Our overall base of customers is expanding and diversifying. This, along with our new corporate structure that is better equipped to serve those customers' needs, will support a future of sustainable growth. Though market conditions remain challenging in the near term, we are confident in the expected long-term growth rates for biologics, for mRNA medicines, for gene editing, and for cell and gene therapy. We believe our serviceable addressable market will double over the next five years, and we expect to be able to outpace market growth with differentiated technology, products, and services. We will continue to put our cash flow and balance sheet to work with select organic investments in our facilities and analytics and product innovations.

We will also continue to look for opportunities for inorganic investment to bolster our market position and provide our customers with additional solutions. We are committed to building a strong foundation for long-term, profitable, and sustainable growth for our base business. Kevin, Becky, Drew, and I are all happy to answer your questions. So now I'll turn the call back over to the operator for instructions.

Operator (participant)

The floor is now open for your questions. To ask a question this time, please press star, then the number one on your telephone keypad. You'll be provided the opportunity to ask one question and one further follow-up question. We'll pause for just a moment to compile the Q&A roster.

... Your first question comes from the line of Tejas Savant with Morgan Stanley. Your line is open.

Tejas Savant (Executive Director and Senior Healthcare Equity Analyst)

Hey, guys. Good evening, and thanks for the time here. Maybe I'll start with one big picture, one on Trey, and just the visibility, particularly into the pharma customer base, right? So emerging biotech, I believe, is about 30% of your total revenue exposure. Can you share just some color on the customer conversations there that you're hearing, especially through November here? And you also mentioned some key customers focusing on capital conservation. So it sounds like it's a very similar dynamic at your larger biopharma customers as well. Is that a fair interpretation?

Trey Martin (CEO)

Hi, Tejas. Yes, thank you. Your number's about right for small and mid-public company exposure, around 30% of our revenue year to date. And, also correct that the, you know, the activity through, large cap pharma has continued consistently. There have been actually quite a few, recent licensure announcements that I'm sure everyone has noticed. But we, we, we see again, that rationalization of program progression and of course, a completely different timeframe expectation than we experienced through the pandemic, for that progression and a return to normalcy that I think we all in the industry hope is, somewhere in between, the, the rapid, you know, the rapid progression of, of the pandemic and, and the time before.

But I would say probably, probably the best person for me to add color, to add, add color there might be Becky, who has just recently had some pretty high-level large pharma customer visits.

Becky Buzzeo (EVP and Chief Commercial Officer)

Hi there. Yeah, you know, it's, we've been talking to many clients, you know, big pharma, small biotech, even academic clients. For sure, budgets are tight. We also are getting a lot of information around program rationalization, so, slowing new entrants into their pipeline and really progressing programs that have the best view of a positive outcome. There are continual conversations around de-risking programs. So, many times what this means is getting additional development data packages so that the filing is successful. So with that, we're seeing some delay in filing those initial INDs and instead, you know, kind of going back and doing further optimization on sequences and analytics.

Operator (participant)

Next question comes from the line of Catherine Schultz with Baird. Your line is open.

Tom Peterson (Senior Research Associate)

Hi, thanks. This is Tom Peterson on for Catherine. I appreciate you taking the time for our questions today. I was wondering to start, if you could first speak to, you know, what you saw throughout the business as the quarter progressed, and particularly in September. I guess, you know, what was the exit rate in the quarter and, you know, what have you seen into October?

Trey Martin (CEO)

Yeah, sure. We have a bit of a third-month effect. I think we've described that previously, where we have rescheduled shipments that go out at the end of each quarter. Largely speaking, though, part of the reason for our guide down is, I would say, a particularly soft July and August, more in line with that July. So September, again, with the third-month effect, was relatively strong, actually. But we are now guiding to essentially a constant rate for the rest of the year, of what we saw in Q3.

Operator (participant)

Our next question comes from the line of Matt LaRue with William Blair. Your line is open.

Matt LaRue (Analyst)

Hi, good afternoon. You know, one thing you reiterated today was the long-term guidance through 2028, and, you know, assuming that the COVID contribution you gave at the R&D Day holds, that would require a base business CAGR of 25%, over that time frame. And, you know, the base business grew around 23% from 2018 to 2022, so this would be, you know, a faster CAGR on a larger base through 2028. So, you know, given how much uncertainty there is in the end market, could you just maybe speak to the confidence level, you know, in the long-term trajectory? And understanding you're not giving 2024 guidance, you know, to hit those levels, we have to, we have to start growing again at some point.

You know, when do you really start tracking back or working your way back to that level of growth that's required to hit those long-term targets?

Trey Martin (CEO)

... Yeah, sure. Thanks, Matt. This has obviously been a bit of a correction year, and we are, you know, I think from a correction standpoint, the TAM and SAM markets, you know, the estimates that people use, including us, will probably be adjusted down for a bit of a step down. And as you say, then it's about what the growth rates are coming back out. And as you identified, we have our base business, and we have the COVID program material. I would say the example we had where we took single digit millions out of the COVID is a good example of how we see activity already starting to shift across a broader base of non-COVID programs. And again, our material inputs are fungible in that way.

We do definitely have 2023's post-COVID CleanCap to work around, but we also have a lot of confidence in the long-term growth rates, and in particular, look forward to, as we announce two partnerships that are in the CRISPR gene editing area today. We look forward to what we think will be a very exciting growth and market uptake for CRISPR gene editing, which is both a therapy in itself and a tool, you know, to make cell and gene therapies. And I think a lot of the activity there has been well publicized.

We're looking forward to, you know, a much broader and less concentrated customer base, with many more programs progressing, and are very optimistic about the growth in the mRNA, gene and cell therapy and CRISPR gene editing markets over that five-year period.

Operator (participant)

Our next question comes from `the line of Michael Ryskin with Bank of America. Your line is open.

Michael Ryskin (Managing Director)

Great, thanks. I'm actually going to ask a two-parter. First, I want to follow up on exactly the last point, but maybe I'll just drill in on the near term, a little bit more on the non-COVID piece. I mean, you've had just on dollar terms, declines there for three or four quarters in a row now, and you're guiding to another decline in Q4, I believe. Can that segment grow next year, or have you sort of, you know, zeroed out all the adjustments and all the, you know, rebasing that needs to happen? Just because there was a period of such elevated growth in the prior years, and especially as you say, some of that stuff can move between COVID and non-COVID pretty easily.

I'm just trying to figure out what the right floor for that is when, when that can start growing again, and, you know, this year in the 150s, is that a floor or is there still some more, some more excess, non-COVID to come out of that? And then, if I can squeeze in a second part, I want to ask about the cost cuts, the $30 million. First, I want to make sure, is any of that having a benefit in Q4, or is it only really kicking in next year? And if you could just provide a little bit more specifics, you know, is it on the—it sounds like it was pretty heavily on the, on the manufacturing side, but also on SG&A.

If you could just sort of break that through across the different buckets, how we should think about it, that'd be helpful. Thanks.

Kevin Herde (CFO)

Yeah, Michael, I'll start with the second part of your question on the cost realignment initiative. Yeah, I would say geographically on the P&L, it's roughly going to be 50% hitting the COGS line in the operational reductions, primarily in our nucleic acid production segment, sort of rightsize those operations to the post-pandemic volumes that we're seeing. And the other 50% predominantly is going to hit our SG&A line. We'll focus a little bit more on the G&A component of that as we continue to see the appropriate investments in our commercial channel, paying dividends for us over time. So basically, a 50/50 split between COGS and SG&A. We have been cognizant, certainly, of the revenue declines throughout the course of this year, and thus have cut back certain discretionary spend items.

Actually, yesterday was the primary day in which we took action on the elimination of roughly 100 positions. So those certainly will incur a one-time severance charge here in our fourth quarter and roughly be out of our ongoing P&L for a portion of this quarter. So that's why I think when you see the decline in our revenue guidance, you see that coming in with a little less dynamic impact to the EBITDA guidance that we had previously given in previous quarters. It's partially mitigated by some of the conscientious cost controls, as well as the impact of the layoffs that we did yesterday. Trey, I don't know if you want to comment on the revenue progression.

Trey Martin (CEO)

Yeah, I mean, a big part, admittedly, in the first 90 days here for me, has been looking at our monthly, you know, revenue progression and performance and focusing really on the reorg and restructure activities. With, with, you know, facing the reality that we see today, we are certainly optimistic that this, the, the, let's say, the, the leg down in July and August will be, you know, will, will set the stage for, you know, the next level of growth, but are certainly not ready to call, you know, that pivot point. So the, the, again, the reorg, the realignment has been based on the first three months where I've been in seat here, which, unfortunately, have been three lower months of revenue compared to the past.

But we're on a, you know, I think, a relatively stable keel now going forward and have taken basically a more of the same approach for Q4 for the rest of the year, which is the reason for the guide, the guide down.

Operator (participant)

Our next questions come from the line of Conor McNamara with RBC Capital Markets. Your line is open.

Hey, guys. Thanks for taking the questions. I think I've got one for each of you around the $30 million cost cuts. First, Trey, if you think about those cost cuts, I mean, it sounds like they're in manufacturing and probably some in sales. Does that - How does that, if any, impact your ability to hit the growth rates that you've talked about historically? And, you know, at your R&D day, if you're still gonna hit that target, will these cuts allow that? And then, as a follow-up, Kevin, just, you know, assuming you still can't hit your revenue, is it, you know, should we just think about that $30 million helps that whatever your EBITDA margin target was that you had outlined for those plans?

Kevin Herde (CFO)

Yeah, I'll take the first, the last second part of that and just touch on it. Yeah, again, those reductions are about half in the operating lines and about half in the SG&A line, but predominantly more in SG&A and not on the commercial side, as again, we continue to invest there. It's also important, I think, as we went through this exercise, it was, you know, we looked at the business in a couple different manners. You know, we looked at the overall reduction in kinda cash costs, which are predominantly labor and variable costs, and it's around a 20% reduction of those of the company.

But we were very specific in targeting areas that we thought we could reduce without impacting our ability to grow at the rates in, in the modeling in which we're projecting going forward. And I think we've done that, and the, all the teams across the company and, and the new, the leadership that we have, you know, came together to, you know, agree on a plan that both had financial targets, but also made sense operationally and made sense to Trey as he's reorganizing the company in the manner that we wanna move going forward. So yes, I think we feel we've made the right reductions that are realistic and prudent based on where revenue currently has, but does not hamstring us to hit our long-term growth objectives. So I'll just, I'll leave that component of the question there.

Trey Martin (CEO)

Yeah, and I'll add, it's an insightful question. I would say that really our... Again, 50/50 between operations and G&A, so there are two elements to it. From an operations footprint perspective, this is all essentially fixed labor, where you set up shifts and have capacity available, whether it's chemistry, production or contract mRNA, or, and so on. And I would say the level that we made changes there is really a function of two overlapping principles. One being that we were holding some capacity for residual COVID business, and the decline of the residual, you know, legacy-type pandemic COVID business is faster than expected over the last two quarters. So that's a faster decline.

And then the diversified next generation mRNA business, we're essentially dialing in, you know, a slower potential growth rate of that in conjunction with the faster decline in COVID. So it is an insightful question because we certainly have the capacity and capability needed for the broader and more diversified customer group to do many more things with mRNA. It unfortunately will not be, you know, 70% of sales for one compound, for one customer like it was, you know, in 2021 and 2022. It will be a much more diversified group of smaller projects, which I hope brings stability and predictability to the business.

On the G&A side, it's a similar, I would say, realization that, our company in its current size, that you're all very well aware of, and, can't afford or sustain necessarily the level of corporate shared services that we had imagined, you know, in a size, 3-4x our current size. So we will, we do obviously intend to be a high growth, high, high Adjusted EBITDA company, and, as we, as we grow at a slower rate back from this place, we will have the ability to incrementally add. But our fundamental structural capabilities and operations are still there where they need to be, strategically aligned.

Kevin Herde (CFO)

Yeah, and specific to the question on margin, Conor, I mean, certainly one way to look at this is certainly to look at this as if it sort of had occurred at the beginning of this year. You know, which would take, sort of on an adjusted basis, our roughly low 20% margin that we're talking about today in our guidance and increasing that to roughly 30% or so. You know, and I think that from our perspective, you know, it's the right thing to do in the current environment. I will tell you that, you know, we are not a big cost structure company, so you know, this was a big, a big reduction for us....

And a lot of our ability to derive margin expansion from the levels we're at now will certainly come from top-line growth, and that will continue to be the case. But we did feel, obviously, that it is prudent to adjust our cost structure, and be able to reset, streamline our operations in light of a tough macro environment. And just frankly, because, you know, certainly the visibility to this return to growth is still hazy for most people in our industry and not overly clear. I don't think anyone's assuming that there is a spring back January 1, 2024. I think it's gonna continue to be working with our customers, understanding their needs and, you know, positioning ourselves to support that.

That's what we're currently doing, and that's certainly one of the main reasons we're deferring our 2024 guidance until we complete those discussions and get as good of an understanding as we can have heading into 2024 and completing that year.

Operator (participant)

Our next question comes from the line of Dan Arias with Stifel. Your line is open.

Dan Arias (Managing Director)

Thanks for the questions here. Trey or Kevin, can you just maybe talk to biologics safety performance in China and then outside of China, to kind of compare what's going on there, and then how you might expect those two buckets to trend into year-end? I imagine China is the softer of the two, but curious about what the difference might actually look like there.

Kevin Herde (CFO)

Yeah.

Trey Martin (CEO)

Yeah. Thank you. We looking specifically at China BST, which again, was a big growth driver for them in 2021 and 2022, really, the difference between what we've been talking about so far and that, is that the leg down for China in BST really started in the second half of last year. Having just looked at a lot of the numbers, obviously, we are, I would say, relatively stable at this new level. So there are year-over-year comparisons from growth that are now steady, that were harder for us, certainly in the second half last year and first half this year. So we see China, not so far, not taking any further steps down, but at a relatively stable rate for the past three quarters in BST, specifically.

Kevin Herde (CFO)

Yeah, just to put some numerical context to that. In the second quarter of 2022, when we first saw this decline that Trey alluded to, China was about 19.5% of the revenues for our BST business. In the most recently completed quarter, China was 19.5% of the revenues in the BST business, and it's ranged from 18.4%-22.9% in those periods that I just spoke to. So it's leveled out, we don't have, we believe, ongoing exposure to see that go much lower than that. I think that's the level that's gonna support the current environment that we're seeing for biologic manufacturing in China.

Operator (participant)

Our next question comes from the line of Matthew Skys with Goldman Sachs. Your line is open.

Vivian Cai (Investment Banking Analyst)

Hi, this is Vivian for Matt. Any updates on the progress of Flanders Two, and how are you thinking about bringing on additional capacity in a year where demand is being impacted by destocking, COVID rolling off and weaker pharma spend?

Kevin Herde (CFO)

Yeah, I'll start. Yeah, certainly not ideal to bring online additional capacity in this year, but you know, these are decisions you make at least two years in advance, just given the length it takes some of these facilities. And frankly, that it's still necessary, and we still think it was the right decision. We need to have redundancy for our manufacturing of CleanCap. Flanders One accomplishes that, and obviously, it was funded through our BARDA grant. Flanders Two, again, a big part of our commercial strategy, and I'll let the others in the room comment on that.

That's certainly something that, you know, we're not rushing to finish, obviously, given the demand, but it is certainly something that in the context of commercial discussions, is an incredibly important asset that we need to have and is frankly table stakes to be a key, key competitor in the nucleic acid solutions part of our business.

Trey Martin (CEO)

Yeah. So Flanders Two, specifically, is where the mRNA services happen, you know, at phase two and beyond. We have our existing GMP services for chemistry and for mRNA, all in the Wateridge facility that there's a nice picture of in our, in our deck here. So as we talk through customer program progression, we have the ability to turn that on at the right time for the right customers. And obviously, with all the work we've done this quarter on right-sizing and realigning our operations footprint, we have not, you know, proactively leaned into Flanders Two until we have solid bookings scheduled. And I, Becky can probably just add a few comments because that's been her primary focus here this last quarter.

Becky Buzzeo (EVP and Chief Commercial Officer)

Yeah, sure. I mean, look, we're incredibly excited about the Flanders Two building, and I think that you know, you're always gonna be building ahead when you're offering more of that GMP manufacturing facility footprint. We have a number of customers that have come through our research use only manufacturing services. They've then progressed to file an IND, and we've made that GMP material for them, and now they have interest, and they're going into phase 2, and then sometimes it's a phase 2-3 combo. And so in those cases where it lines up that we're going to be, you know, GMP ready mid-next year, those are the customers that we're engaging with that are on that same pathway to need that clinical material for phase 2 or a phase 2-3 combo.

And so we continue to progress that, and I think that's a, you know, definitely a great development in our ability to continue to service customers, and be best in making CleanCap mRNA, which is what, you know, is really what we do well.

Operator (participant)

Next question comes from the line of Jaquet Boris with Deutsche Bank. Your line is open.

Boris Jaquet (Global Head Distribution, Corporate Bank, Trade Finance & Lending)

Hi, good afternoon, everyone. As you look at the composition of the NAP revenue to date and the funnel that you have now, is there a way to help us think about what proportion is sort of a recurring revenue or a way to think about visibility going forward? That's sort of like part one. Then part two would be just any thoughts on the competitive landscape. I know that, you know, your lead times have come down a lot, and there's also been a lot of capacity that has come online across the industry as well. It'd just be helpful to have a sense of your perspective on the landscape there as well.

Trey Martin (CEO)

Yeah, I'll take a quick stab at the competitive landscape, and then hand to Drew for your first question. So the, you know, as we focus on the front end of the development funnel, there's more diffuse competition there, where the competition in services specifically has come up significantly is really at the, you know, large CDMO level, where there are fewer programs. So there's, you know, the competitive landscape is sort of meeting in the middle with large CDMOs who have recently brought mRNA capacity to the market, reaching back into earlier phases and discovery folks such as us progressing through from discovery through phase one, through phase two, and so on.

Since about two-thirds of our TriLink revenue is discovery, we are really, I think, being more affected there by new project starts, slowdowns, or delays than specific competition. So then I'll hand to Drew for the first part of your question.

Kevin Herde (CFO)

Sure. Thanks, Trey. Look, I think it's difficult to put a precise percentage on it in recurring revenue terms. I think we have, you know, there are customers in discovery who order from us on a regular basis and that tends to recur. We have some platforms that were built into that that do order on a quarterly basis and we supply regularly. As you get further into clinical trials, you know, whether we're supporting with reagents like CleanCap or whether we're supporting with clinical trial services, you know, it may be a recurring piece of business so long as that program continues to advance through the clinic, but the advancement of that program through the clinic may not occur on a regular quarterly basis.

So there may be stocking events at certain phases of the clinical trial, and there may be manufacturing events at certain phases of the clinical trial. So hopefully that helps get to your question, but it's really a mix of both and not always in a consistent quarterly pattern on the clinical trial activities.

Operator (participant)

We are now out of time. I'd like to turn the call back over to Deb Hart, Senior Director, Investor Relations.

Deb Hart (Senior Director of Investor Relations)

Thank you, Jenny, and thanks, everyone, for your time today and for joining the call. We'll be at a couple of conferences next week and hope to catch up with many of you there. Have a good evening.

Operator (participant)

This concludes today's conference call. You may now disconnect.