Maravai LifeSciences Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
February 22, 2024

There are 11 speakers on the call.

Operator

Good afternoon and thank you for standing by. At this time, I would like to welcome everyone to the Q4 2023 Maravay Life Sciences Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. I would now like to turn the conference over to Deb Harte, Head of Investor Relations.

Operator

Please go ahead.

Speaker 1

Good afternoon, everyone. Thanks for joining us for our Q4 year end 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 our agenda for today on Slide 2, Trey will first provide you with a business update and Kevin will review our financial results and guidance.

Speaker 1

Drew Burch, President of Nucleic Acid Production, will join the call for the question and answer session following our prepared remarks. We remind you that management will make forward looking statements and refer 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 detail 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.

Speaker 1

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

Speaker 2

Thank you, Deb, and good afternoon, everyone. We appreciate having you join us for our call today. Let's start with our financial results on Slide 5. Today, we reported $289,000,000 in revenue for the full year and adjusted EBITDA of $65,000,000 Our 4th quarter results of $74,000,000 in revenue were stronger than anticipated due to outperformance in our base nucleic acid production segment, specifically for Clean Cap and Custom Chemistry. Turning to Slide 6, our nucleic acid production segment had revenue of $59,000,000 in Q4.

Speaker 2

This includes an estimated $18,000,000 of COVID clean cap revenue. For the full year, total nucleic acid production revenue was $225,000,000 with the base NAP revenue at $164,000,000 COVID Clean Cap revenue was $61,000,000 for the year. Our Biologic Safety Testing segment contributed $15,000,000 in Q4 $64,000,000 for the full year. Our Q4 base non COVID revenue company wide was $56,000,000 dollars up from our Q3 total of $52,000,000 As we exit the 2023 calendar year and begin 2024, we're entering a new era for Maravai, which we are referring to as Maravai 3.0. Let me provide some context for that on Slide 7.

Speaker 2

As many of you know, Maravai was originally founded nearly 10 years ago by Carl Hull and Eric Tardiff along with the support and backing of GTCR. This was Maravai 1.0, a private equity backed company with a strategy to consolidate differentiated founder based life science tools companies with industry leading technologies and very strong brands. From 2016 through 2020, Maravai acquired 5 companies, including Trialing Biotechnologies and Cygnus Technologies in 2016, Glenn Research in 2017. Each of these acquisitions serve unique niches in the industry and this roll up strategy was extremely successful. As the pandemic hit in 2020, we entered a new phase.

Speaker 2

Many of our existing customers pivoted their focus to develop a COVID vaccine, including BioNTech, which was already using TriLink's CleanCap technology for its mRNA vaccine and therapeutic development. Marvite 2.0 was primarily focused on the scale of oleic acid products, specifically on the Cleancap product needed to meet global pandemic vaccine demand. We scaled our production of Clean Cap from grams to kilos, transitioned from RUO grade to GMP quality and move to running 24 hour shifts 7 days a week. This was an important period from Rovi as it allowed us to prove our ability to scale and demonstrate CleanCap's clinical potential in the form of billions of safe and effective vaccine doses. During this period, we decided to take the company public in November of 2020.

Speaker 2

Throughout the pandemic period, we were able to leverage our profitability and strong cash flows to reinvest into scaling our operations and expanding our footprint. We finished the build out of our Water Ridge facility well ahead of plan, started building our Flanders 1 and 2 GMP facilities and moved our biologic safety testing team into a brand new state of the art facility in Leland, North Carolina. We also made additional complementary acquisitions, including MiChem, a nucleic acid chemistry leader and Alphazyme for specialized enzymes, each of which is also part of our nucleic acid production segment. So an incredible amount of capability, capacity and infrastructure came from the pandemic era that will serve us today and throughout the next decade. Let's turn to Slide 8 and Marvye 3.0.

Speaker 2

Marvye 3.0 is the post pandemic phase for our company, our new normal. The capability and infrastructure additions that came from pandemic era investments give us a foundation for exceptional operating leverage going forward. We're not trying to replace COVID vaccine revenue with a single program or a single customer. We are focused on bringing innovation to the entire mRNA production workflow, building on capabilities in emerging adjacent product and service areas where we can differentiate ourselves and diversify the business for long term sustainable growth. In fact, we believe that 2024 will be the most diversified customer base we've had in the last 5 years.

Speaker 2

More on that in a moment. We are organized with 2 main reporting segments, nucleic acid production and biologic safety testing. Within NAP, we have TriLink Biotechnologies, Glen Research and Alphazyme. And BST is our Cygnus brand including the Mach V technology acquisition. Each of our brands have very strong histories and customer relationships.

Speaker 2

They act not only as product suppliers, but technical experts who consult and help customers through their development and scale up challenges. Acquisitions remain a key component of our strategy moving forward. We believe we're in the right markets, specifically all mRNA platforms as well as CRISPR gene editing in cell and gene therapy. It starts in the discovery market for each of our businesses and we have a unique ability to translate discovery products and services all the way through to GMP. Our value proposition of winning customers in discovery and supporting them through commercialization is stronger than ever.

Speaker 2

Marvy 3.0 is about being a leading innovator playing a key role in the future of genomic and personalized medicine. We believe we will continue to differentiate ourselves as a technology leader and the first choice partner for our customers. I think we are privileged to have the opportunity to be part of this next generation of medicines with the goal of helping to improve human health. Turning to Slide 9, let me share an update from a third party analysis we commissioned specific to our Clean Cap programs. You may recall that we first did this exercise in February 2022 and identified over 180 preclinical and clinical trials using CleanCap.

Speaker 2

We updated that research in December 2022 and saw overall growth of over 70 programs. Our annual refresh of that work was recently completed and we have now identified over 3 50 programs that use Clean Cap or more than 100 new programs in the last 12 month period. This includes preclinical through commercialized programs for a variety of different conditions. Note that 3 different CleanCap analogs are used in the production of 3 different mRNA products that have received full regulatory approval, which is really exciting. CLINCAP AG3 Primal methyl is in the Pfizer BioNTech vaccine.

Speaker 2

ClinCap AU is used in a self amplifying vaccine approved for use in Japan. And ClinCap AG is also in a vaccine approved for use and marketed in Japan. Looking at the pipeline by clinical phase, you'll note that 3 out of 4 of the identified programs are in the preclinical or early discovery phase. This supports our strategy to win in discovery and grow with our customers as they advance through the clinic and to approval. This is true for CleanCap and for many of our other products and services.

Speaker 2

Let's turn to Slide 10. Specific to the CleanCap analysis, growth in the mRNA pipeline was seen across multiple modalities as shown in the left ring chart and for multiple applications including cancer vaccines, infectious disease vaccines and cell therapies that use mRNA. This reflects the widespread interest of big pharma in the mRNA platform technologies and foreshadows what we believe will be a sustained future investments in the field. And as the heat map on the right shows you, the top disease targets of these programs are cancer and infectious disease. Within the infectious disease programs, 16% are COVID related.

Speaker 2

So what we're really pleased with in this latest data is twofold. 1st, we see a notable increase in the programs headed to the clinic and the discovery pipeline is accelerating. 2nd, Phase 3 programs that moved into the clinic 3 to 5 years ago use Cleancap less often than the Phase 1 programs that moved into the clinic last year, suggesting that our strategy to win in discovery is playing out. We intend to support these customers through the lifespan of their developmental programs. One important note, this data does not yet reflect CleanCap M6, which we introduced just last May in 2023.

Speaker 2

Our long term history with mRNA manufacturing process provides a smooth path for our early phase customers looking for ways to move quickly into scale up and clinical manufacturing without having to do a tech transfer. We provide these customers with a faster route by plugging into our platform workflow technology called Clean Script. Our Clean Script platform gets at the heart of what these customers need like reducing double stranded RNA in the manufacturing process instead of trying to remove it downstream. Working with an established partner like TriLink reduces the time and risk for clinical stage production. Specific to TriLink, in Q4, we provided a limited set of customers with early access to a small scale mRNA offering for screening and sequence optimization.

Speaker 2

We have received multiple orders from industry leading organizations, early evidence that we're on the right track with how we evolve our portfolio to enable early stage discovery programs. Through this offering, we expect to expand into key screening markets upstream from the current marketplace, providing cross selling opportunities and adding to our customer base. And after launching CLNCAP M6 last year, we have over 170 discovery customers working with it. Several of whom have shared their intent to incorporate M6 their preclinical and clinical studies over the next several quarters, reinforcing our strategy of winning in discovery. We are also pleased to share that Alphazyme now sells enzymes used in the IVT process for mRNA production.

Speaker 2

We believe we can gain both market share and share of wallet here through continuous innovation, new product development and exceptional service. We are in a truly unique commercial position in this market because a very large number of biopharma innovators of all sizes come to us first at the earliest stage of their programs for our products and services. Our customer pipeline reflects the future contours of the industry. Let's move to Slide 11. 2023 was another record year of FDA approvals and the development pipeline is meaningfully higher than at any point in history.

Speaker 2

In fact, the FDA approved nearly 50% more novel drugs in 2023 than in 2022, putting it back on pace with historically high levels. The FDA approved 55 new innovative therapies containing an active ingredient or molecule not previously approved in 2023, up from 37 in 20 22 51 in 2021. The agency also approved 7 new cell and gene therapies in addition to the 55 novel drugs. You've no doubt seen in the news and heard commentary from some of our peers that the FDA is increasing staff and aiming to improve the drug approval process and expedite drug approvals for orphan diseases, in particular, establishing an accelerated approval for gene therapies. This bodes well for our products and service offerings now and in the future as we work to support our customers' programs from discovery to late phase development.

Speaker 2

Let's move to Slide 12 and the facilities update. We are poised to achieve late phase manufacturing capabilities for cGMP mRNA in 2024 and continue the acceleration of our innovation across all businesses. Specific to our Flanders 1 site, we've had several requests for GMP CleanCap M6 and plan to start producing it in Flanders 1 by mid year. For Flanders 2, we received our first booking from a customer to produce late stage mRNA drug substance in 2024 and other customers are showing strong interest. The pipeline for IND enabling clinical materials is strong and the moves we made in early 2023 to upgrade our commercial teams and our facilities are getting us in front of customers and their RFP processes.

Speaker 2

Our customers have confidence in our operational readiness plans and our technical and manufacturing teams to meet their clinical timelines. With both of our Flanders facilities coming online and our new analytical sciences center of excellence in San Diego, we will be well positioned to be our customers' partner of choice as the number of mRNA drugs moving into clinical phases continues to accelerate. Our commercial strategy under Becky Buzzo's leadership is to win in discovery with the right products and services and to continue to support the unique needs of our mRNA and cell and gene therapy customers during their clinical development programs through to full commercialization. The strategy also includes fostering key academic and industry partnerships to enhance innovation and accelerate market adoption of the latest technology. Our 2024 return to growth requires that we protect and grow the unique core capabilities we currently have in each business.

Speaker 2

There are also markets for us to disrupt and differentiate ourselves, such as the evolution of our enzyme capabilities at Alphazyme, MachD viral clearance testing at Cygnus and custom mRNA at TriLink discovery. As we look to 2024 and beyond, the need for Maravise products and services for these early stage programs is greater than ever. Let's move to Slide 13 and an update on our intellectual property. Our recent patents issued in China and Canada reinforced the global strength and protection of TriLink's intellectual property, adding new jurisdictions of enforcement to the Clean Cap Patent Estate, which already includes the United States, European Union, Australia, Japan, Korea and Hong Kong. We now hold the IP for Cleancap materials and methods in major markets across the globe.

Speaker 2

Importantly, drug developers in China will now have expanded access to license authentic Clean Cap technology. Now please turn to Slide 14 and some further exciting developments from Rovi. We signed clean cap mRNA programs in clinical trials. We have enabled Fujifilm Toyama Chemical as a CDMO with the ability to manufacture CleanCap mRNA to further enable our global customers with access to an in country CDMO of choice in Japan. The agreement includes all forms of QueenCap, including our latest Queen Cap and 6.

Speaker 2

As we continue to focus on new product innovation, Glenn Research, our high quality provider of fluorophores, Quentrus labels and modifiers for oligonucleotide synthesis published Glenn Report 35.2. The Glenn Report has been in publication since 1987 and serves as a well regarded resource for the many scientists engaged in DNA and RNA research and oligonucleotide synthesis. 3 new phosphoramidate products were announced in our latest issue, including M6AM. The M6AM phosphoramidite is the same monomer that is found in clean cap M6 affording access to the modification in RNA oligos for future biologic study. Our Cygnus team recently signed a strategic partnership with Dyadic to provide a new C1 host cell protein ELISA assay, extending our product leadership in HCP detection.

Speaker 2

The kit has been qualified with many drug substances and in process samples, providing the specificity and sensitivity to detect C1 host cell protein impurities with reproducibility that supports the downstream purification monitoring, product lot release and regulatory compliance. And Cygnus continues to shine in the cell and gene therapy market supporting all 19 of the 19 CAR T gene and cell therapy approvals for Lant Release. Cygnus is with the drug developers all the way from process development through commercialization. Now turning to slide 15. You saw in our press release that we're introducing our 2024 revenue guidance of $265,000,000 to $285,000,000 As I mentioned earlier in the call, we believe our 2024 revenue will be the most diversified since 2019.

Speaker 2

Prior to the pandemic, our top 10 customers represented about a third of the overall business. Then during the pandemic, our top 10 customers jumped up to represent over 80% of total revenue. Last year, our top 10 customers accounted for less than 50% of overall revenue. We believe our top 10 revenue concentration will continue to decline over time we expand our customer base, increase our product offerings and take advantage of cross selling opportunities. We believe we will continue to build stronger customer intimacy and drive sustainable durable growth as Maravai 3.0.

Speaker 2

We are in a unique position to provide a concierge level experience for customers that makes it easy to do business with us, whether through enabling faster turnaround time, incorporating novel chemistries or creating flexible partnerships. We are viewed as a high quality experienced partner that can manage a very challenging technology, which many others in the industry are not equipped to do. I couldn't be more excited for Maravide 3.0 and I know that we can continue to make significant contributions to improving human health. We are energized for a new year and our renewed focus on supporting our customers to accelerate their discoveries to provide life changing medicines for patients worldwide. I'll now ask Kevin to cover our Q4 and full year performance along with more details on our guidance and our model assumptions.

Speaker 2

Kevin?

Speaker 3

Thanks, Trey, and good afternoon, everyone. As Trey mentioned, we are pleased to have finished 2023 ahead of expectations and we are excited to move forward into 2024. I will briefly cover our financial results for the Q4 full year of 2023 and then discuss financial guidance for 2024. Before I get started on our results of core operations, I want to address the 2 large GAAP based non operating line items on Slide 17 that likely drew some attention in our press release issued earlier today. As a result of shifting to a GAAP based pre tax loss in 2023 and assessing our forward looking GAAP book income projections, we have recognized a valuation allowance against our deferred tax assets as of year end.

Speaker 3

The recent history of our pre tax loss is considered a significant piece of objective evidence that is difficult to overcome and limits the ability to consider other subjective evidence such as future growth projections. Thus, in consultation with our technical accounting and tax advisers, we believe it is appropriate to establish a full valuation allowance against our deferred tax assets. Given our Up C structure and the nature of the deferred tax assets predominantly recognized as a result of our IPO in 2020 and subsequent exchanges in 2021, generally no partial valuation allowance is available. Additionally, as our long term tax receivable agreement or TRA and related liability is tied to the usage of our deferred tax assets created via the FTE structure, we have also removed that liability from our GAAP based financial statements. The net impact of these two items is a non cash, non EBITDA, non operating GAAP tax expense of $764,000,000 to establish a full valuation allowance against our deferred tax assets and a corresponding $669,000,000 non cash, non EBITDA, non operating GAAP other income gain tied to the relief of the TRA liability.

Speaker 3

As many of them understand the nature of this, the liability was approximately 85% of the underlying deferred tax asset as is typical in an Up C structure. To conclude on this matter, the underlying deferred tax assets are still available to the company to utilize to reduce taxable income in the future and we may be able to release the valuation allowance once GAAP pre tax income is substantiated. To the extent that deferred tax assets are utilized, the corresponding payment of approximately 85% of those benefits to the owners of the tax receivable agreement will be made and we will include the TRA liability again at the time we release the valuation allowance. The last item to note here is that our GAAP based results are in a book box primarily due to the extent of non cash charges such as depreciation and amortization tied to the accounting for acquisitions and our facility build outs as well as stock based compensation charges. If there are any questions on this technical accounting matter, I'll be happy to take them at a later time, so we can focus this call on the operating results of Maravai.

Speaker 3

So now diving into the financial results for the quarter on Slide 18. Our GAAP net loss before non controlling interests was $110,000,000 for the Q4 of 2023. This compares to net income of $87,000,000 for the Q4 of 2022. Our GAAP net loss for the year was $138,000,000 compared to income of $491,000,000 for 2022. As noted in the consolidated statement of operations, we incurred a GAAP based charge in the quarter of $6,000,000 associated with our previously announced cost restructuring actions.

Speaker 3

Moving to Slide 19. Adjusted EBITDA, a non GAAP measure, was $21,000,000 for 20242023 compared to $130,000,000 for Q4 2022. Our adjusted EBITDA margin was 28% in Q4 2023, above our expectations for the quarter as a result of the higher than anticipated revenues in the quarter and the efficiency of initiating our cost restructuring actions that also benefited Q4 2023. Adjusted EBITDA for the year was $65,000,000 and adjusted EBITDA margin of 23%. This was above the high end of our last updated full year guidance for 2023 for adjusted EBITDA of 55,000,000 dollars to $60,000,000 I will discuss EBITDA by segment in a few slides.

Speaker 3

Moving to Slide 20 and EPS. Basic and diluted loss per share for the Q4 was $0.80 driven primarily by the net impact of the GAAP non cash non operating charges associated with the net impact of the deferred tax asset valuation allowance expense and the change in the TRA liability. Adjusted fully diluted EPS and non GAAP measure was $0.01 a share. For the year, our EPS metrics were basic and diluted loss per share of $0.90 and adjusted fully diluted EPS and on GAAP measure of $0.03 per share. Moving forward to the year end balance sheet cash flow and other financial metrics on Slide 21.

Speaker 3

We ended the year with $575,000,000 in cash and $533,000,000 in long term debt, resulting in a $42,000,000 net cash position. Adjusted free cash flow was $8,000,000 for the quarter and $13,000,000 for the full year of 2023. That calculation of adjusted free cash flow, a non GAAP measure, is based on our adjusted EBITDA less capital expenditures, which were $21,000,000 $13,000,000 in the quarter respectively, and $65,000,000 $53,000,000 for the fiscal year, respectively. For fiscal year 2023, we generated $126,000,000 in cash flow from operations. With that strong operational cash flow, we invested $122,000,000 into expanding our offerings and capabilities to support future growth factors with the acquisition of Alphazyme and investment in our Flanders GMP facility.

Speaker 3

This includes the capital expenditures for 2023 of a net total of 50 $3,000,000 Depreciation and amortization ended the year at $40,000,000 in line with our expectations in previous guidance. Interest expense net of interest income ended the year at $18,000,000 in line with our expectations and previous guidance. This represents effective interest rate of about 3.4 percent for the year, reflecting strong execution on our treasury operations. Stock based compensation and non cash charge was $35,000,000 for the year also in line with our previous guidance range. We ended 2023 with 132,000,000 Class A shares outstanding and 119,000,000 Class B shares outstanding for a total of 251,000,000 shares outstanding at the year end on an as if fully converted basis.

Speaker 3

Fully diluted weighted average share count for 2023 was also 251,000,000 shares. I note that our total Class A plus Class B shares at the end of 22. Thus, our total shares have declined over the past 3 years. As a result of our bifurcated ownership structure, cash that accumulates at PubCo as a result of our equalization of tax distributions have been utilized to effectively retire B units outstanding, increasing the level of Class A ownership. These transactions occurred during 2021 and in conjunction with the acquisition of Alphazyme in Q1 2023 and have effectively used around $180,000,000 of cash to reduce overall Class B shares.

Speaker 3

This has more than offset the dilution associated with stock options and restricted stock issuances to employees and directors of Maravai since the IPO, leading to the reduction of overall shares outstanding over the past 3 plus years. Simply put, while we've issued equity compensation and have seen the non cash stock based compensation charges increase annually, we have also reduced total shares outstanding by virtue of the tax distribution mechanism whereby Pupco has used excess cash received to retire total shares outstanding. Next to Slide 22 and the discussion of segment performance in the quarter. Our nucleic acid production segment, which includes both our Discovery and GMP products and service is market under our TriLink, Glen Research and Alphazyme brands, had revenues in the Q4 of $59,000,000 and adjusted EBITDA of $24,000,000 a margin of 41 percent. For the year, revenues for our NAPP segment were $225,000,000 with adjusted EBITDA of $83,000,000 for a margin of 37 percent.

Speaker 3

Included in the revenues in the Q4 was our estimate of $18,000,000 in revenues associated with CleanCap for COVID-nineteen related vaccine demand. This brings the total estimate of CleanCap for COVID-nineteen related vaccine demand to $61,000,000 in line with our expectations and previous guidance statements. Now to slide 23. Our Biologic Safety Testing segment, which includes products from our Cygnus brand, had revenues of $15,000,000 in the 4th quarter and adjusted EBITDA of $12,000,000 a margin of 76%. For the year, revenue for this segment was $64,000,000 adjusted EBITDA was $47,000,000 for a margin of 73%.

Speaker 3

As detailed in these segment results, the combined adjusted EBITDA, just our operating segments prior to the corporate shared services expenses was $130,000,000 for 2023, a combined margin of 45%, clearly highlighting the financial strength and health of our core operational segments. The corporate shared service expenses impacting total adjusted EBITDA includes centralized functions such as human resources, finance and accounting, legal, IT the incremental expenses associated with being a public company and totaled $15,000,000 in the quarter $64,000,000 for the year. Now getting to our financial expectations for 2024 on Slide 24. We are guiding 2024 total revenues to be in the range of $265,000,000 to $285,000,000 Breaking down the anticipated revenue by segment, we see our nucleic acid production segment to be down about 8% at the midpoint, mostly due to anticipated declines in high volume GMP clean cap demand. And we see the Biologic Safety Testing business achieving low to mid growth over 2023.

Speaker 3

Now as we enter the Maravai 3.0 era, we will no longer be carving out our estimates of COVID related Clean Cap in our guidance or attempting to estimate it on a quarterly or annual basis prospectively. We understand that our customers use our GMP Cleancap for a variety of end uses, including supporting commercially approved vaccines and in research and development programs as our Clean Cloud is a platform technology that is not indication specific and thus fungible in the hands of our customers. Now our 2024 guidance does consider around $50,000,000 in fiscal year contractual non cancelable GMP clean cap commitments made by our customers. As for the cadence of estimated revenues, we have seen in each of our quarters over the past few years less the impact of COVID related Clean Cap carrying between 23% to 29% of the annual total, so a little bit of variability within each year. As we look at 2024 revenues, we see the Q1 carrying about 22% of our 2024 revenues and the first half of the year carrying about 47% of the total for the year.

Speaker 3

So we see the second half weighting slightly higher than the first half, but consistent with our historical variability and consistent with many of our peers' outlook for 2024. Moving to the rest of the P and L. We're on track to realize the previously targeted cost reductions of $30,000,000 of which about 2 thirds were tied to the reduction in our labor force at our San Diego based nucleic acid production and corporate headquarters that was substantially completed in the Q1 of 2024. These targeted reductions will be partially offset by annual cost increases associated with the remaining ongoing labor force and focused investments in our commercial and R and D teams to drive organic growth. Overall, we expect gross margins to be flat to slightly lower than 2023 based on an unfavorable product mix compared to 2023.

Speaker 3

R and D and sales and marketing expenses are estimated to be up slightly on an absolute dollar basis, reflecting our ongoing investment in these areas. G and A expenses are expected to be down about 5% on an absolute basis versus 2023. Overall, we estimate 2024 adjusted EBITDA margins up between 23% to 25%. We see adjusted EPS in the range of $0.00 per share to a $0.06 per share loss. Our guidance also contemplates the following expectations in 2024.

Speaker 3

Interest expense and net of interest income between $25,000,000 $30,000,000 depreciation and amortization between $40,000,000 $50,000,000 equity based compensation, which we show as a reconciling item from GAAP to non GAAP EBITDA to between $45,000,000 $50,000,000 as a fully converted share count of 254,000,000 shares and an adjusted effective tax rate 24%. Lastly, as we have discussed, we are outfitting the final stages of our Flanders facility in the first half of twenty twenty four, which will result in us being substantially complete with all facility investments that we expect will be needed to support our business for the foreseeable future. As such, we anticipate total net capital expenditures to shift down to $30,000,000 to $35,000,000 in total for 2024. Subsequent to this completion, mainly over the first half of twenty twenty four, we anticipate capital expenditures moving down further to annual maintenance and growth investments closer to 5% of total revenues over time. I'll now turn the call back over to Trey.

Speaker 2

So to wrap up on slide 26, we believe we have transitioned during a challenging 2023 to Maravai 3.0 and they're at a new normal poised for a solid and more diversified 2024. From new combo vaccines to cell and gene therapies battling cancer, we believe that the transformative impact that mRNA has on global human health will only accelerate. We believe we are playing in the right target markets with strong leadership positions. We are building our product and services portfolio and expanding our strong brands in strategically important high value areas to support genomic medicine. We are committed to building a strong foundation for long term sustainable and profitable growth with a focus on innovation, scaling our commercial organization, leveraging our new manufacturing scale and inorganic growth opportunities.

Speaker 2

We have this incredible opportunity still ahead of us to participate in the next generation of medicines that are going to better treat and in some cases literally cure disease. This is what fuels our team every single day. We at Maravai are proud of the key role that our customers, partners and employees are playing in making that happen. Then finally, thank you for your attention. To our investors, thank you for your trust and support and we look forward to continued collaboration around fulfilling our mission over the coming years.

Speaker 2

I would now like to turn the call back over to the operator and open the line for your questions.

Operator

Thank you. The floor is now open for your questions. Your first question comes from the line of Mac Leeroux with William Blair. Your line is now open.

Speaker 4

Hey, good afternoon and thank you for taking my question. I wanted to ask just about the guidance. The first would be sort of on the top line you referenced $50,000,000 of non cancelable orders. For the whole space, obviously visibility has been an issue over the past year, year and a half. I'm just curious as you thought about constructing the guidance for a year, if there's any difference in the way you thought about approaching communicating guidance relative to internal expectations or should you see more end market improvement or just some general thoughts on sort of the guidepost around the guide?

Speaker 3

Yes, sure, Matt. Thanks. This is Kevin. I'll take that. Look, I think we feel good about the guidance range.

Speaker 3

I think as we sit here today versus where we were say a year ago, the overall percentage of our revenue that we see either having been recognized throughout the course of the year, sitting in PEO or sitting in some of these contractual commitments like you mentioned, is higher than it was. And that puts us on a good spot. It's near 40% of our full year guidance and it was closer to a third probably a year ago. So that gives us some conviction that we do have a good grasp of the full year and that's incorporated in our guidance.

Speaker 4

Okay. Thank you, Kevin. And then just on the EBITDA guide, I think the midpoint of that sort of margin and revenue mix is around $66,000,000 You just reported about $20,000,000 in the 4th quarter. And recognizing that there are things like incentives, comp reset in the Q1, just curious if I sort of look at the distinction between the annualization of Q4, which I know is a fool's errand. But if I do that relative to the midpoint of the guide, maybe just help us understand the other moving parts beyond top line here in 2024?

Speaker 3

Yes. Well, I think if you take the 275 times the mid range of the EBITDA, you get 66 And again, that's relatively consistent with where we ended the full year of 2023. We do see certainly a step down in revenue versus where we ended up $23,000,000 in the midpoint of our guidance. So that's a big component of it. I'll also tell you that we did put in obviously some cost actions.

Speaker 3

We did benefit probably off the tune of around $4,000,000 in the Q4 of 2023 of that $30,000,000 overall target. So the year over year benefit there is about $26,000,000 So about half of that is coming down due to lower revenue at the midpoint and the remainder are some of the things, one you mentioned the normalization of compensation practices and then certainly the continued investment in commercial and R and D. As we sit here today, we have about 40% more sales heads than we did at the end of 2022. And that's been a concerted focus of us, particularly as we morph into Maravai 3.0 to have that strong sales force. So that's a reinvestment, as we move forward.

Speaker 3

As it relates to the margin cadence, we're going to see some continued variability quarter by quarter as we did in 2023. I think if you see the 2nd Q3 of 2023, our EBITDA margins were in the mid teens. They're down in the low 60s of revenue. And certainly given our implied guidance for the Q1 based on the Q1, roughly 22% of the full year, that's about a $60,000,000 number for Q1. We expect the EBITDA margin for the Q1 to be relatively consistent with that mid teens sort of level and then increasing from there.

Speaker 3

And as it has done historically, our key toggle for margin expansion is really the top line and we'll continue to see margin expansion as top line grows moving into that full year estimate of 23% to 25%.

Operator

Our next question comes from the line of Justin Bowers with Deutsche Bank. Please go ahead.

Speaker 1

Justin, are you there?

Speaker 5

Yes. Good afternoon. I was on mute. Sorry about that. I just wanted to take a step back.

Speaker 5

At a high level, can you just talk about the demand environment and how that's evolved, let's say, over the last 3 to 6 months? It looks like you're sort of calling for an inflection and a bit of a return to growth when we strip out some of the COVID clean caps. So just wanted to get a sense of sort of the drivers behind that as a starting point?

Speaker 2

Yes, thanks. This is Trey. We are seeing, I'd say, 1st and foremost, willingness to make binding commitments again, which is something that is obviously a welcome change. As you identified and as we discussed in the material, we're coming off of a period, well, the pandemic period really was intensely weighted toward heavy customers with large orders. We're coming into a very nice diversification, growing the number of customers significantly and so on, seeing demand.

Speaker 2

But of course, these are smaller POs and smaller checks. Ultimately, it will lead to a much more diversified and, I would say stable and predictable business. But in this transition, we are, I would say, for demand, seeing more customers come in. We are they're unfortunately not massive customers of the pandemic era, but we've also seen again this recommitment to binding forecasts. And maybe I'll hand it to Drew for a little more color.

Speaker 6

Yes. Thanks, Trey. I think Trey described it well. We've annualized some of the pandemic era commitments. So we'll move past that.

Speaker 6

We have seen a greater diversity of customers and I think the chart that Trey showed on the number of clinical trials using CleanCap speaks to some of those dynamics as you see those numbers continuing to go up at a pretty significant rate. So we'll replace some of those larger commitments with a broader diversity of customers and I think that augurs well for the future.

Speaker 5

Thank you. And then just maybe just a quick follow-up. What sort of the shelf life or the process to validate efficacy on the clean cap? There's been it's a question that we get a lot and there's been, I guess, a wide range of estimates out there. So we'd just like to get your perspective on that.

Speaker 6

Yes, sure. It's true. I'll take that. It's a customer driven decision how they will choose to use their inventory and we support customers with retest dates and also with retesting services. We're pleased that Cleancap has held up well from a stability standpoint and our customers work to make decisions about how they want to manage their own inventories.

Speaker 5

That's it for me. Thank you.

Operator

Our next question comes from the line of Catherine Schulte from Baird. Please go ahead.

Speaker 7

Great. Thanks for the questions. In your prepared remarks, you mentioned that a larger portion of programs entering Phase 1 last year used Cleancap versus that stat a few years ago. I guess what was that number in terms of the portion of programs entering Phase 1 last year that utilized Cleancap just to try to get a sense for market share?

Speaker 1

Catherine, we're looking at that stat.

Speaker 2

We've got a table with all of them. So you're asking the number of Phase 1 programs at the end of last year versus this year? Yes. Total in Phase 1 at the end of 2022 was 69 and total of Phase 1 at the end of 2023 was 86.

Speaker 7

Okay. I was more referencing you mentioned that a larger CleanTAP was used more

Speaker 5

frequently in programs entering Phase

Speaker 7

1 if you had like a what

Operator

stuff?

Speaker 2

Yes, yes. It's about 40%.

Speaker 7

Okay, great. That's very helpful. And then maybe for the Q1 guide, implies a decent sequential step down in revenue. How should we think about the outlook for biologic safety testing versus nucleic acid production in that first quarter number?

Speaker 3

Yes. So most of that MAP segment. Again, a lot of that is tied to the high volume GMP clean cap. We actually see biologic safety testing stepping up in the Q1 as it has done a lot historically having strong Q1 performance. So I think you'll see a step up in BST over Q4 and then offset by NAP coming down again predominantly due to the high volume GMP clean capital pattern that we're seeing for 2024.

Speaker 7

All right, great. Thank you.

Operator

Our next question comes from the line of Michael Ryskin with Bank of America. Please go ahead.

Speaker 8

Great. Thanks guys. Got a couple of quick questions here. Appreciate the Q and A. One was on the $50,000,000 in contractual in 2024.

Speaker 8

I know you also just said you really don't want to talk about it, but still I just want to make sure we're thinking about it correctly. You had about $60,000,000 or $65,000,000 I believe that was $60,000,000 to $65,000,000 that was contractual in 2023, you got $50,000,000 in 2024. Anything you can say in terms of when that ends? I just want to make sure we're modeling it correctly when that rolls off, just because that could be a pretty meaningful headwind, in 2025 if that all comes to an end. And I've got a follow-up.

Speaker 8

Yes.

Speaker 3

Well, I think as you know with under most of our license and supply agreements, we work with our customers for rolling annual rolling 12 month forward looking forecasts, right? So certainly, as we sit here today, we're very comfortable with our guidance and what we're speaking of related to those commitments. And as we go through the year, we'll be working with our customers as that rolls forward into 2025 and certainly thereafter.

Speaker 9

I think

Speaker 3

it's I mean that's sort of the mechanisms on how that works. But right now we're sticking sort of to that clear view that we have right now today.

Speaker 8

Beautiful. Thanks. And then sorry,

Speaker 2

go ahead.

Speaker 9

I was

Speaker 2

going to say the last year number that we what we were publicly sharing was the carve out for COVID specific large committed programs and that number was 61 as we had forecast before.

Speaker 9

Okay.

Speaker 8

Yes. Thank you. And then my follow-up question I was going to ask on this Fujifilm partnership. We've gotten a bunch of questions over that in the last couple of weeks. Anything any additional comments you can make beyond what you had in the prepared remarks?

Speaker 8

And any way to possibly size that because that seems like it could be pretty meaningful, sort of how much of that is assumed in 2024? Thanks.

Speaker 2

Yes. The key that will depend on Fuji's customer signings as a CDMO. So that's sort of a 2 degrees of separation for us that would be difficult to forecast, but really key partnership in country in Japan, and notable because it includes the entire portfolio of Clean Cap. But we have several CDMOs that have been enabled, giving hopefully as customers have the opportunity to work with us particularly in later phases as Flanders 2 opens later this year. But if they need more scale or they need geographic choice, that's the reason for the in multiple jurisdictions like that.

Speaker 2

And this is, as you say, this could be very meaningful, but it does depend on the programs that they are able to book in Japan.

Speaker 9

Okay. All right. Thanks. I'll get back in the queue.

Speaker 1

Thanks, Dan.

Operator

Our next question comes from the line of Connor McNamara with RBC Capital Markets. Please go ahead.

Speaker 9

Hey, guys. Congrats on a solid quarter and thanks for taking the question.

Speaker 6

Just if you do look

Speaker 2

at Q4 results, you came

Speaker 9

in about $5,000,000 ahead of what you were expecting, if my math is correct. And just was there anything in there as far as bulk purchases or anything pull forward from 2024 that's worth calling out or is that just execution?

Speaker 3

Yes, I would say thanks, Connor. I would say one, nothing pulled forward. I think it was pretty normal quarter for us in that regard. We did have what we kind of call some drop in orders, meaning things that weren't really in our funnel that our customers came in and that really provided the upside to what we are thinking for the quarter. And that happens occasionally, again, as our and mostly for Clean Cap, certainly as customers maybe enter a new phase or start a new program, they're going to order in bulk and there was a larger order that came in again not in our funnel that we see and that happens periodically and leads to some of that quarterly volatility.

Speaker 3

But it's just a strong quarter versus our internal estimates and we're happy about that.

Speaker 6

Yes. It's Drew. I would add on I think the efforts that have been undertaken in the past few quarters on our commercial execution for fruit. So we saw some good traction with the commercial team and really just getting that clean cap opportunity and other offerings in front of the customer base in a more forward leaning way.

Speaker 2

I think we talked last year about how there was some reticence for these committed orders, the take or pay type arrangements, which may also largely dissipate with the pandemic. But this is a sort of upside positive consequence of people not necessarily committing to take or pay, but still needing the material. And that's the reason, as Kevin said, that it was not in funnel, but we were able to take it and execute within the quarter.

Speaker 3

Got it. Great.

Speaker 9

And then as it relates to guidance, looking at what you said about the first half or second half on revenue, that implies the second half, you'll do roughly $75,000,000 a quarter in the second half. Should we expect then EBITDA margins would be roughly in line in the second half of twenty twenty four to what you guys did this year? Or is there any headwinds or tailwinds that would make that much different? And then just as a follow on, I mean is that a

Speaker 2

good place to start for

Speaker 9

as we think of beyond 2024?

Speaker 3

Yes, I think you got it exactly right, Conor. Obviously, as we move up into the type of revenue performance that we saw in the Q4 of 2023, we had a strong EBITDA margin exiting the year of 28%. And I think as we're in and around that revenue level, that's certainly what you can expect

Speaker 9

Great. Thanks guys. Appreciate it.

Operator

Our next question comes from the line of Matt Sipes with Goldman Sachs. Please go ahead.

Speaker 10

Hi, this is Eva Koslowski on for Matt. Thanks for taking my questions. The first one, how are customer conversations trending in terms of bioprocessing recovery within the different modalities that you called out in the slide? So basically, is there one modality where you're seeing more positive commentary relative to the others?

Speaker 2

Well, yes, that's an interesting question. The distribution of that you would be getting into cell platforms that people are using for production. And I would say we are returning back to normal for BST, where there was some distortion, for example, in a bit I mean, this gets into the technical weeds, but in CHO versus E. Coli and so on, where we had some platform slowdown, they have recovered, I would say back to the normal proportion of sales. But there are multiple modalities that can be expressed in the different cell lines.

Speaker 2

And so that's really a couple of clicks further than we get, in particular since many of the Cygnus customers are also CDMOs or distributors. So there is we unfortunately we don't have that level of visibility into which specific program they're in or how many kits they're using for a certain cell line for a certain expression of a Mab or things like that, if that's what you're asking?

Speaker 10

Yes. I think more in terms of like cell therapy versus mRNA vaccines in those types of modalities And how customer comments like comments are trending within each of those modalities?

Speaker 6

Yes, it's Drew. Maybe I'll jump in on that. I think the I can't say we've seen a market difference between cell therapy and mRNA. I think we've got engaged customer dialogues on both fronts. The data you saw the data in terms of growth of clinical trials.

Speaker 6

There's a1000 near a1000 clinical trials underway clinical and preclinical trials underway for mRNA, smaller number for gene editing, but both those numbers have grown quite a bit over the past year and both are forecasted to grow by 30% or more over the upcoming few years. And our dialogues, I would say, are consistent with that. We're excited about the customer traction. We're excited to have a customer signed up to initiate production with us in Flanders 2. So overall, I would say it's kind of a balanced optimism across the portfolio.

Speaker 10

Okay, great. That's super helpful. And then with your 2020 revenue target of $700,000,000 and taking into consideration the new 2024 guide, how confident are you in the step up of growth necessary in the 2025 to 2028 in order to reach this target? Thanks.

Speaker 3

Yes, sure. I think that if you just look at the math there, I think you're looking at a CAGR that would be in in the range of $1,000,000. Certainly, we're building this business out and making investments with those targets in mind. And that's the reason why we continue to be focused on things like Flanders 2, expansion of commercial, R and D innovation, etcetera. And I think that is not a growth target that we're unfamiliar with.

Speaker 3

If you look back to our core business growth from 2018 to 22, we grew at 23%. So and I think as we sit here today, as we look forward under Maravide 3.0 versus those previous years, you have a lot more programs, a lot more dollars flowing into this space, a lot more excitement in and around it. And we have a lot more, as Trey alluded to, capabilities, products and opportunities and customers involved. So I think it's something that we continue to be focused on certainly as we build out our footprint strategically. But having been said, our goal right now is really focused on delivering what we just put out there for 2024 and starting to get the business returning to growth.

Speaker 10

Okay, great. Super helpful. Thank you.

Speaker 1

Thanks, Edi. And operator, I think we have time for one last question, please.

Operator

Yes. And for our last question, this comes from the line of Paul Knight with KeyBanc. Please go ahead.

Speaker 2

Yes. Thanks for the time. As we look at various biotechnology firms, are they dedicated to 1 capping technology or are they agnostic and do they really look at alternatives? Yes. I think when anyone that's insightful question by the way.

Speaker 2

When anyone is starting a new program or ideally in discovery, they should be looking for the best technology at that time. So I think to that extent, you're as a given customer may be agnostic at a moment in time. They certainly have their favorites and then it depends on whether they producing themselves or have a partner. If we are the partner, as I mentioned in my comments, we have

Speaker 8

a

Speaker 2

We're sorry about the planes going overhead. And that also is quite efficient and quick. But I would say though we have people who are dedicated clean cap customers, partly the reason that we're so excited to continue innovating and adding new options to the menu is that we think at a given stage of their clinical development, they should always try to incorporate all of the best technologies with M6 being the most recent example. What's the last stage they what can they are they limited at they really have to commit what at Phase 1, I'm guessing they committed Phase 2, right?

Speaker 6

I think that's usually the case that people are going to commit as they go into clinical trials, maybe switch a little bit later. We see the greatest degree of switching as products and programs are entering the clinic. But I think to Trey's point, we continue to work hard to bring new options that are going to help customers optimize their programs. And so we're excited that KLEENCAP AG, KLEENCAP 3 Primo Methyl and KLEENCAP SA are all in KLEENCAP AU are all in products that have been approved at this point. M6 is moving along nicely and we have quite a bit of interest there to move that into GMP production.

Speaker 6

And so there's not one size fits all. We continue to try to bring innovation to customers to help their programs achieve as much as they can possibly achieve.

Speaker 9

Thank you.

Speaker 1

Great. Well, with that, we would just like to thank everyone for joining us today. We'll be at several conferences over the coming months, so hope to catch up with some of you in person there and feel free to contact us with any follow-up questions. Hope you have a great night.

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Key Takeaways

  • For full year 2023, Maravai reported $289 million in revenue with $65 million of adjusted EBITDA, and Q4 revenue of $74 million, driven by stronger‐than‐expected nucleic acid production sales.
  • In Maravai 3.0, the company will shift away from pandemic‐dependent revenue, focusing on post-pandemic diversification across all mRNA platforms and CRISPR gene editing, aiming for its most varied customer base in five years.
  • The CleanCap pipeline has expanded to 350+ mRNA programs (including 100+ new in the last year), with three CleanCap analogs already in approved vaccines and early traction for the M6 variant among discovery customers.
  • By mid-2024, Maravai will bring its Flanders 1 and 2 GMP facilities online for late-stage mRNA production and launch a new San Diego analytical center, positioning it for scale-up and commercial manufacturing.
  • For 2024, revenue is guided to $265–285 million with an adjusted EBITDA margin of 23–25%, while capital expenditures are expected to decline to $30–35 million as facility build‐outs wrap up.
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Earnings Conference Call
Maravai LifeSciences Q4 2023
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