Maravai LifeSciences Holdings, Inc. (NASDAQ:MRVI) Q3 2023 Earnings Call Transcript

Maravai LifeSciences Holdings, Inc. (NASDAQ:MRVI) Q3 2023 Earnings Call Transcript November 8, 2023

Operator: Ladies and gentlemen, thank you for standing by. My name is Tammy 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. [Operator Instructions] I would now like to turn the conference over to Ms. Deb Hart. Please go ahead.

Deb Hart: 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: 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 in private equity-backed investment.

As a result, key customers continue to focus on capital conservation efforts, which is 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 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 Biologic Safety Testing revenue was $16 million in the third quarter. Turning to Slide 6, as you are all aware, Maravai grew at an exceptional rate during the pandemic as we scale 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 4 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 announced 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 are 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 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 are 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’s 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’s, Cygnus, Glenn Research and Alphazyme to support their scientific endeavors. Moving forward, operating divisions have been redefined and remained to reinforce our strong brands, where we have 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, Glenn 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’s Discovery internally 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’s Discovery will include all research use only for 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’s 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’s 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 1 and 2 facilities. Our TriLink’s GMP includes GMP CleanCap Analogs, GMP and 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 defined 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 traditionally 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.

Meaning on decades of technical expertise, TriLink’s 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 in 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, 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 turn 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, 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 Invitrogen mMessage 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 in 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 a distinct potential to insert, excise or eliminate DNA in a broad spectrum of genetic diseases.

In late September, we entered into a nonexclusive supply agreement for several of our CleanCap analogs to be used in the Elixirgen Scientific Japan Inc, mRNA development and manufacturing services for preclinical through Phase 3 programs, including CleanCap M6, CleanCap AG and CleanCap AG 3’Ome. This agreement aligns with our objective to enable greater access worldwide to all clean cap mRNA technologies. In addition, we also reviewed a multiyear 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 and 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 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. Cygnu’s Technology 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 retrovital clearance whenever they wish from their own lab rather than requiring the use of a contract research organization.

and do their own testing at a fraction of the costs associated with prior viral clearance studies. CleanCap M6, our next-generation Cap analog received a 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 suffice it 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 needed to the San Diego Business Journal’s 2023 list of leaders of influence and LifeSciences. And 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 for the industry’s recognition of our innovative products. Turning to Slide 13. As we look ahead to the completion in 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: Thank you, Trey, and good afternoon, everyone. Starting on Slide 15. As per our press release this afternoon, our Q3 2023 revenue 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 basic and diluted EPS were at $0.05 per share loss, while adjusted fully diluted EPS was $0.01 per share loss for the quarter. Our GAAP-based net loss for 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 9 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 reflecting 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% on 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 our prudent actions as we wait the broader market conditions to improve and 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 determined 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 this segment was $59 million, a margin of 35% on the 9-month revenues of $166 million. Including 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 9 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 apertures. 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 to $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 to $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 have stated we had $65 million in CleanCap POs for the year-end 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 customers’ COVID vaccines specific demand for CleanCap.

As we have discussed previously, our CleanCap franchise has multiple chemical analogs, which are not target specific and this 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 disability. 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 Biologic Safety Testing revenues this year to be about $62 million to $64 million, shifting slightly lower than our previous estimate of $65 million to $70 million for 2023.

The business continues to see the leveling of demand in the $15 million to $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 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 negative $0.01 per share in earnings and our adjusted EBITDA to be between $55 million and $60 million and adjusted EBITDA margin of about 20% to 21% on our updated revenue guidance. Additionally, we expect the following financial expectations as listed on Slide 19. Interest expense, 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 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’s 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: 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 gene and cell therapy. We believe our serviceable addressable market will double over the next 5 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 organic and 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.

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Q&A Session

Operator: [Operator Instructions] Your first question comes from the line of Tejas Savant with Morgan Stanley. Your line is open.

Tejas Savant: Hi, 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 to sounds like it’s a very similar dynamic at your larger biopharma customers as well. Is that a fair interpretation?

Trey Martin: Hi, Tejas. Yes, thank you that your number is about right for a small mid public company exposure around 20% of our revenue year-to-date. And also correct that 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 see, again, that rationalization of program progression and, of course, a completely different time frame expectations than we experienced through the pandemic for that progression and a return to normalcy that, I think we all the industry hope is somewhere in between the rapid – the rapid progression of the pandemic and the time before. But I would say probably the best person for me to add color, color there might be Becky, who has just recently had some pretty high-level large pharma customer visits.

Becky Buzzeo: Yes, we’ve been talking to many clients, 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 derisking 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 kind of going back and doing further optimization on sequences and analytics.

Operator: Next question comes from the line of Catherine Schulte with Baird. Your line is open.

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

Drew Burch: Yes, sure. We have a bit of a third month effect. I think we’ve described that previously where we have rescheduled shipments to go out at the end of each quarter. Largely speaking, though, part of the reason for our guide 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: Our next question comes from the line of Matt Larew with William Blair. Your line is open.

Matt Larew: Hi, good afternoon. One thing you reiterated today was the long-term guidance through 2028 and 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 the base business grew around 23% from 2018 to 2022. So this would be a faster CAGR on a larger base through 2028. So given how much uncertainty there is in the end markets, could you just maybe speak to the confidence level in the long-term trajectory? And understanding you’re not giving 2024 guidance, they hit those levels, we have to start growing again at some point. So 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?