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Maravai LifeSciences Holdings Inc. (MRVI -0.65%)
Q4Â 2020 Earnings Call
Mar 02, 2021, 5:00 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Ladies and gentlemen, thank you for standing by, and welcome to Maravai LifeSciences' Q4 2020 earnings conference call. [Operator instructions] Please be advised that today's conference is being recorded. [Operator instructions] I would now like to hand the conference over to your host, senior director, investor relations, Debra Hart. Madam, you may begin.
Debra Hart -- Host, Senior Director, and Investor Relations
Thank you, Latif. Good afternoon, everyone. Thanks for joining us on our first quarterly earnings call as a public company. On today's call, we will cover our financial results and business highlights for Maravai's fourth-quarter and full-year 2020, and we'll provide financial guidance for 2021.
Our CEO, Carl Hull, will first provide a business update; and our CFO, Kevin Herde, will review our financial results and guidance. Our president, Eric Tardif, is joining us, along with Carl and Kevin, to answer questions following the prepared remarks. As a reminder, the forward-looking statements that we make during this call, including those regarding our business goals and expectations for the financial performance of the company are subject to risks and uncertainties that may cause actual events or results to differ. Additional information concerning these risk factors is included in the press release we issued earlier today as well as those that are more fully described in our filings with the SEC.
Today's comments reflect our current views, which could change as a result of new information, future events, or other factors, and the company does not obligate or commit itself to update these forward-looking statements except as required by law. During this call, we will be using non-GAAP measurements of certain results and in providing guidance. Reconciliations of GAAP to non-GAAP financial measures are included in the press release that we issued this afternoon, which is posted to the Maravai website and also available on the SEC website. The metrics that we will be discussing in today's call include net income, adjusted EBITDA, income tax expense, and adjusted earnings per share.
These adjusted financial measures should not be viewed as an alternative to GAAP measures but are intended to better enable investors to benchmark our current results against historical performance and the performance of our peers. Now I'll turn the call over to Carl.
Carl Hull -- Chief Executive Officer
Thank you, Deb, and good afternoon, everyone. I'd like to take a moment to welcome our newest group of investors to Maravai. As Deb said, this is our first earnings announcement as a public company, and we are very pleased to have you with us. In addition, I would like to take this opportunity to extend my personal thanks to each and every member of the Maravai team who, together, have positioned us to make meaningful contributions to the battle against the COVID-19 pandemic.
Without them and their sustained efforts, we would not be speaking with you here today. By way of introduction, for those of you new to Maravai, we provide reagents and services focused on high-growth markets in cell and gene therapies, vaccines, and biologic drug manufacturing. As a supplier of solutions to other life sciences companies, we are positioned nicely to benefit from multiple tailwinds that are affecting the sector from early discovery through clinical trials all the way to the commercialization of healthcare products. Our customers include the top 20 global biopharmaceutical companies as well as emerging biopharma and life science research companies, leading academic research institutions, and molecular diagnostic companies.
All of this resulted in our exceptional performance in 2020 with full-year revenues of $284.1 million, representing a growth of 98.5% over 2019. Kevin will take you through the details of our financial performance in just a moment. Prior to that, let me explain a bit more about each of our businesses and their current focus. Our TriLink BioTechnology subsidiary is a leader in messenger RNA synthesis, supporting a large number of vaccine and therapeutic programs, most notably with our co-transcriptional capping technology CleanCap, which has become critical to the successful scale-up of manufacturing capacity for mRNA vaccines and therapeutics, including several COVID-19 mRNA vaccines.
CleanCap is a novel chemical capping analog that optimizes the cap structure of an mRNA molecule and provides for the improved stability of and protein expression by the mRNA itself. The many advantages of CleanCap include high-capping efficiencies of greater than 94%, higher yields of usable messenger RNA, simplified manufacturing processes as well as reductions in the unwanted activation of the body's innate immune system. CleanCap enables our customers to produce large quantities of mRNA drug substance reliably and more quickly. CleanCap is provided to customers in one of three ways.
First as a stand-alone chemical component that is purchased as either a research-grade or customer-specified GMP-grade product. Second, it can be incorporated into an mRNA construct as a custom service offered by Maravai or as a catalog item. Finally, CleanCap can also be incorporated into a GMP-grade custom mRNA solution provided its scale to our biopharma and vaccine customers. As you can see from the results we released today, 2020 was a year of exceptional growth, profitability, and transformation for Maravai.
While we are very pleased by these results, it is not lost on us that much of that performance has been driven by the work we're doing to help address a global health crisis that has had such a devastating impact upon so many. We are extremely proud of our contributions to the fight against the pandemic and of our ability to scale our operations to meet the explosive demand we are seeing for our products. You can be assured that we'll continue to work diligently to support all of these public health efforts in the future. We and others in the field believe that the intense worldwide efforts to develop mRNA vaccines for the COVID-19 pandemic have helped to accelerate the development of mRNA applications of all stripes and by several years.
The rapid success of these pandemic mRNA programs has validated therapeutic modality that is built around messenger RNA, not only for use in COVID-19 vaccines and any potential boosters that may be needed to address variance of the virus but also as a platform technology for seasonal flu and other infectious disease vaccines, along with cell and gene therapeutics. COVID-19 vaccination programs remain a significant immediate opportunity for Maravai and CleanCap, and we expect demand to continue to increase during 2021 as vaccine manufacturers scale production, as additional mRNA vaccine programs receive regulatory authorization for use and as modified vaccines are developed to address multiple new strains of the virus over time. While the definitive clinical research is still very much under way, it's becoming increasingly likely that a periodic booster shot to counter threats from emerging strains of SARS-CoV-2 or from waning natural immunity will be an important part of public health toolbox for some time to come. As a vaccine platform technology, mRNA has demonstrated its unique ability to be rapidly and accurately modified as the virus evolves.
We expect to be an important part of these new and modified programs being developed by our existing CleanCap customers. Multiple recent industry developments bode well for the accelerating momentum we are already seeing within our nucleic acid production business. The rapid expansion of manufacturing capacity for COVID-19 vaccines has involved multiple, new, large-scale commercial partnerships, some of which would have been quite hard to imagine pre-pandemic. Examples include Novartis and Sanofi have been contracted by Pfizer and BioNTech to support their recently revised 2021 production goal of 2 billion vaccine doses, up from the previous target of 1.3 billion doses.
CureVac and Bayer have joined forces to accelerate the production and global distribution of the first generation CureVac COVID-19 vaccine with expectations to begin shipments by the end of 2021. CureVac and GlaxoSmithKline announced a parallel effort to expand the production of that first-generation vaccine further by over 100 million doses during 2021 while beginning the immediate joint development of a multivalent second-generation vaccine intended to address future virus mutations. And finally, we have this morning's announcement about Merck supporting Johnson & Johnson with their vaccine program. Pfizer's project Lightspeed is reducing the manufacturing time needed to produce a COVID-19 vaccine batch from 110 days to an average of just 60 days, allowing for an increase in weekly U.S.
production from 5 million to 10 million doses in March within their existing facilities. CureVac's European regulatory review is now progressing rapidly. The EMA just initiated a rolling review of the vaccine candidate. The rolling review will assess the vaccine's efficacy and immunogenicity as the data become available, speeding the final decision process for eventual marketing authorization.
Various recent comments from industry leaders, including the CEOs of Pfizer and Johnson & Johnson, have highlighted the potential need for COVID vaccine boosters similar to seasonal flu shots for the foreseeable future. And our partners at Pfizer and BioNTech are taking the necessary steps and engaging in the appropriate conversations with regulators to be in a position to develop and seek authorization for an updated mRNA vaccine or booster once a strain that significantly reduces the protection provided by the existing vaccines is identified. The FDA just last week issued guidance concerning the much more limited clinical testing that they will require for such modifications to the existing COVID-19 vaccines. Moreover, the significant investments made in vaccine development have paved the way for mRNA's use in other areas as we are seeing a resumption of activity in a number of mRNA therapeutic programs that were paused at various points last year.
These programs include cell and gene therapies, addressing other high-value, unmet clinical needs such as immuno-oncology vaccines, enzyme replacement therapies, immunotherapy or CAR-T treatments and recently emerging gene-editing approaches. We are well-positioned to serve our biopharmaceutical customers throughout the explosively growing mRNA field and across a wide range of clinical programs for multiple different diseases. In addition to COVID vaccines and the therapeutic GMP service programs that utilize CleanCap today, we have also worked with over 400 customers who have used our CleanCap technology in support of their own research and preclinical work. Our nucleic acid production business also includes Glen Research, which provides a wide range of reagents used in the synthesis of DNA and RNA.
Glen supplies our reagents to researchers investigating diverse genetic diseases and disorders, companies developing new genetic therapies and molecular diagnostics, and life science OEM partners who incorporate Glen Research offerings into their products. Biopharmaceutical customers are increasingly relying on outside parties to provide important inputs and services for their clinical research and manufacturing programs, a development driving growth for those suppliers with unique capabilities and the ability to manufacture at an appropriate scale and level of quality to support these customer programs. We believe that our rare combination of scientific capabilities, proprietary technology, and the requisite investment in manufacturing and quality systems positions us well for continued growth. To ensure our ability to stay ahead of demand and be a trusted partner to our customers, we made significant investments in 2019 and 2020 to expand our nucleic acid manufacturing capacity, expanding initially to five dedicated manufacturing suites to produce materials under customer-specified GMP conditions.
In addition, our three new CleanCap manufacturing suites and three new plasma DNA manufacturing suites are now up and operational as of the first quarter of 2021, allowing us to supply our customers with much-needed CleanCap reagents and DNA plasmid for their own mRNA, gene editing, or cell therapy programs. Turning to biologics safety testing. Cygnus Technologies is a global leader in providing critical assays for detecting impurities during biotherapeutic process development and commercial manufacturing. This technology is used to ensure the safety of the biologics manufacturing process and the drug products themselves.
We are known for our quality, consistency, and for the broad menu of kits we have available. We saw strong demand for all categories of these assays, especially for our host-cell protein ELISA kits. Our HCP antibodies are proprietary, and therefore, can only be supplied by us. We believe that the proprietary nature of our know-how and the long-standing quality reputation of our products has solidified our long-term customer relationships here.
Our MockV acquisition in early 2020 is now fully integrated as part of the biologics safety testing segment, and we expect that it will contribute to growth beginning in the 2022 time frame. Turning to protein detection. Our vector laboratories brand provides research products for labeling and detecting proteins in cell and tissue samples. Our protein detection assays have been recognized for their performance for over 40 years, and we continue to innovate as we see a large and growing need for the accurate characterization of protein expression patterns in tissue samples during early research.
While our protein detection business was negatively impacted last year by COVID-related lab closures, we expect to return to 2019 revenue levels during 2021 as scientists and academics continued to return to their laboratories full time. Finally, I'd like to comment briefly on the M&A landscape. As you know, we built our business by acquiring established and emerging companies with strong scientific foundations in our target markets and then by investing in their systems, processes, and people in order to accelerate their growth and expand the application for their technologies. Going forward, we will continue to seek a balance between driving substantial organic growth and opportunistic acquisitions that meet our stringent financial and operational requirements.
Let me now ask Kevin to cover our fourth quarter and 2020 performance in some more detail and to provide our initial guidance for 2021. Kevin?
Kevin Herde -- Chief Financial Officer
Thank you, Carl, and good afternoon, everyone. First, I'd like to echo Carl's remarks and thank all of our employees and business partners for their tireless commitment and efforts over the last year. It's through these efforts that we have become the strong company we are today. Now I will review our financial results for the fourth quarter and full year of 2020 and provide our financial guidance for the full year of 2021.
As you have seen in our press release this afternoon, we delivered strong financial performance for both the fourth quarter and full year of 2020. Our Q4 revenues of $98.4 million represent 173.5% reported growth from Q4 2019. For the full year of 2020, we reported record revenue of $284.1 million. This year-over-year increase of $141 million represents 98.5% annual revenue growth.
Operationally, we continue to prioritize key areas of investment in the company. We made important capital investments in our San Diego nucleic acid production manufacturing site with a significant portion of our spend dedicated to increasing overall production capacity, quality systems, and automation. We have also continued to invest meaningfully in our infrastructure to support long-term growth through investments in further enhancing our IT systems and security, our quality systems and processes, our environmental health and safety programs, and our global supply chain efforts. Now to provide more insights into our overall financial performance.
As Carl mentioned earlier and as shown in our press release, our nucleic acid production business fueled the most significant portion of the revenue growth for the fourth quarter and the year. Our nucleic acid production segment represented 79% of the company's total revenue in the fourth quarter and 73% for the full year, compared to 51% for the full year of 2019. CleanCap revenue to support only our COVID-19 vaccine customers was $51.4 million in the fourth quarter of 2020 and was $99.3 million for the full year of 2020, showing the accelerated demand we saw in the second half of the year. Our biologics safety testing business contributed 14% of the company's revenue in Q4 and 19% for the full year.
This business grew by 21.8% in the quarter and 23.6% in the year driven by the ongoing market growth of biologic drug development programs and the high quality and breadth of our host-cell protein ELISA kits. Our protein detection business accounted for 7% of revenue for the fourth quarter and 8% for the full year of 2020. Now moving on to our statement of operations. Our GAAP-based net income before the amount attributable to noncontrolling interests was $14.5 million for the fourth quarter of 2020 and was $78.8 million for the full year of 2020.
Adjusted EBITDA, a non-GAAP measure, was $64.4 million for Q4 and $169.2 million for the full year of 2020, compared to $13.9 million for Q4 2019 and $62 million for the prior year. This is a 363% increase for the quarter and 173% increase year over year. This overall full-year increase in adjusted EBITDA of $107 million was primarily driven by overall sales, volume leverage, and margin improvements from our nucleic acid production business. Our cash and cash equivalents, which are both GAAP metrics, totaled $236 million at December 31, 2020.
With a year-end cash balance of $236 million, $550 million in long-term debt, and our trailing 12-month adjusted EBITDA of $169 million, we exit the year with a 3.3 times gross debt-to-adjusted EBITDA ratio and 1.9 times net debt-to-adjusted EBITDA ratio We continue to have a strong balance sheet and cash flows. And these factors, along with the $180 million available on our undrawn credit revolver, combined with the growth that we see for 2021 that I'll talk to next, continues to provide us with the strategic flexibility to make investments to fuel organic growth while also actively evaluating M&A opportunities. Now moving to our 2021 guidance. Because of the restructuring of the company associated with the November IPO and the Up-C structure that was put in place, we will not be referring back to or attempting to reconcile historical GAAP EPS or share count information as it is not consistent with our current structure moving forward.
Today, we are setting our 2021 full-year revenue guidance at $580 million to $630 million, reflecting growth in the range of 104% to 122%. Included in that range is our estimate for 2021 CleanCap revenues directly attributable to COVID-19 vaccine customers that we are estimating at $370 million to $400 million. Because of the continually evolving demand for CleanCap as well as the inherent choppiness in supporting our gene and cell therapy customers through their multiple manufacturing cycles, we will not be providing individual quarterly breakouts of revenues at this stage. However, we expect Q1 2021 total revenues to be up sequentially in the range of 30% to 35% over our reported Q4 2020 total revenues.
For background on how we establish revenue guidance, our largest customers are generally under master supply agreements in which they provide us with rolling forecast out for several quarters that are further supported by binding POs that may go out for several months. On top of that, we have a forecasted funnel for our GMP suites, which are used to mainly support builds for our customers' nucleic acid therapeutic programs. Based on these factors, our 2021 revenue guidance is based on a good degree of forward visibility. Based on those revenue expectations, we expect our adjusted EBITDA, a non-GAAP measure, to be in the range of $350 million to $390 million, which, at the midpoint of that range, represents growth of 119% and an implied adjusted EBITDA margin percentage of 61% when applied to the midpoint of our 2021 revenue range.
Adjusted fully diluted EPS, a non-GAAP measure, is expected to be in the range of $0.80 to $0.90 per fully diluted and fully converted share. Adjusted fully diluted EPS is based on the assumption that all Class B shares are converted to Class A shares, which results in a forecasted fully diluted share count of approximately 260 million shares for the full year of 2021. The net income included in the adjusted fully diluted EPS has been adjusted to eliminate any net income or loss attributable to noncontrolling interests as a result of the assumed full conversion of Class B shares for Class A shares. Additionally, our adjusted fully diluted EPS, including certain adjustments that do not reflect our core operations, are based on an adjusted effective tax rate range of 24% to 26%.
Now as it relates to certain adjustments to get to our non-GAAP adjusted EBITDA range, we see the following items in 2021: interest expense between $30 million and $35 million; depreciation and amortization, also between $30 million and $35 million; and adjusted tax rate of 24% to 26%; and lastly, we expect equity-based compensation, which we show as a reconciling item from GAAP to non-GAAP adjusted EBITDA to be $10 million to $12 million in 2021. I would like to note that our Q4 2020 results had approximately $21.5 million in equity-based compensation tied primarily to the vesting of certain performance-based units within the pre-IPO LLC structure that was above the normal run rate for this non-cash expense line item. For 2021, we expect to invest an estimated $20 million to $25 million for capital expenditures, including approximately $5 million to complete the last planned phase of our San Diego facility expansion. As you can see, we've successfully scaled the organization in the midst of tremendous growth.
We delivered a record year of performance in 2020, including making substantial investments in the company to further support our continued success. Our 2021 guidance is a reflection of these investments, our view of continued strong growth, and the overall strength of our business model. I'll now turn it back to Carl for some final remarks.
Carl Hull -- Chief Executive Officer
Thanks very much, Kevin. Before we wrap up and turn to questions, I'd like to provide some very high-level perspective on 2022 and beyond. While we aren't ready to provide guidance for 2022 yet, we are seeing customers already booking production capacity for the first half of that year. As Kevin just mentioned, we have a direct line of sight into the book of CleanCap demand for 2021, which continues to grow, and our 2022 outlook is starting to build nicely with additional mRNA vaccines coming to market and the expansion of our strong existing partnerships with industry leaders in mRNA therapeutics.
It is our belief that COVID-19 vaccinations will continue to be needed for years to come in order to address new strains of the virus that emerge as selective evolutionary pressure is created by partially completed immunization programs. This suggests that we should expect COVID-19 to become either an endemic disease or similar to seasonal influenza requiring multipronged and ongoing public health interventions. We expect that mRNA vaccines will continue to be very relevant, if not essential, to those interventions. Unfortunately, the science is now telling us that our initial high hopes of this being a one-and-done vaccination effort are unlikely to be realized anytime soon.
We have all learned a lot about viruses, infectious diseases, critical care, PPE, diagnostics, and vaccines in the past 14 months. It's time now to apply that knowledge to comprehensive public health programs that aim to successfully eliminate new COVID-19 infections in all communities across the globe. I'd now like to turn the call back over to Latif to open the line for your questions. Thanks.
Questions & Answers:
Operator
Thank you, sir. [Operator instructions] Our first question comes from the line of Tejas Savant of Morgan Stanley. Your question, please.
Tejas Savant -- Morgan Stanley -- Analyst
Yes. Hi, guys, and congrats on the solid performance out of the gate here. So one quick question for you, Carl. Your updated '21 guide seems to suggest an incremental sort of 650 million doses or so versus the 750 million that at least we had in our model.
That comes to about 1.4 billion doses for '21. First of all, is that in the right ZIP code? And if so, how should we juxtapose that versus the comments you made on BioNTech's goal of 2 billion doses for '21 as well as potentially some upside from CureVac toward year end?
Carl Hull -- Chief Executive Officer
Yes. Well, thanks for the question, Tejas. And I think what we're dealing with here is a question of apples and oranges. I know that the models are out there that look at consumption by unit of vaccine and what that dose equilibrates to in terms of revenue for us.
We do it from the opposite direction. We are actually looking at the orders that we have on the books today from our customers and the projections that they have given us for their future demands. So to the degree that there is a difference between the output of the model and that order book, it's really a function both of timing and calculations and other things like that. So I'll never be able to reconcile those adequately for you, but I can just tell you that we're guiding to what our customers tell us they're going to buy for us.
Tejas Savant -- Morgan Stanley -- Analyst
Got it. Very helpful, Carl. And then in terms of just the ongoing steady-state consumption of the vaccine, it's still early days, and there this -- your comments around the likelihood of a booster shot and the virus becoming endemic and so on. How should we think about sort of a normalized run rate in sort of '22 and beyond? I mean, the question that we've been getting, obviously, is around now you've had this nice pull forward in '21, but what does it mean for an ongoing run rate for CleanCap in '22, '23, and '24?
Carl Hull -- Chief Executive Officer
Yes. Very good question. It's going to depend on evolution. Right? As the virus evolves to the degree that it evolves in a way that it escapes the existing vaccine protections that are provided, then you're going to have to modify it.
That could be something that happens once a year. It could be something that happens once every three years, you just don't know. But that's going to be the catalyst for changes in the vaccine, and thus, the frequency of the reinoculation programs. I think the other issue is this whole question of waning immunity, and we really don't know yet how durable the immune response is from a completed two-dose vaccine or even a single-dose vaccine.
It's thought to be good, but we don't have a lot of experience under our belts. So to the degree that, that happens and the absence of the antibodies is indicative of perhaps ineffective immune response, that will also drive the frequency of repeat inoculations. So my honest answer to you is, I don't know, but we're thinking, and our customers seem to be signaling that you're going to see some reinoculation every 12 to 18 months.
Tejas Savant -- Morgan Stanley -- Analyst
Got it. Very helpful. And then one quick one on CleanCap sort of production capacity. I mean how future-proofed are you? I know you opened up the three suites here.
But beyond that, I mean, is there anything incremental you need to do to deal with sort of this unprecedented demand situation?
Carl Hull -- Chief Executive Officer
Kevin, would you like to take a shot at that?
Kevin Herde -- Chief Financial Officer
Yes. Sure. I'm happy to. Certainly, the expansion we made here in San Diego included a lot of automation, a large-scale waste management, numerous manufacturing efficiencies.
We continue to see improvements in that yield, better utilization, more efficiencies, and certainly CleanCap orders at large scale. So as we look at this today through our current lens of pricing and mix, we actually see a little higher capacity than we had previously projected. Now comfortable that we can support over $1 billion in revenue annually for a nucleic acid production out of the San Diego facility.
Tejas Savant -- Morgan Stanley -- Analyst
Perfect. Got it. And then, Carl, any early color you can share on the plasmid DNA launch? I mean, obviously, since you guys have invested in that capacity, you still have some of the competitors. Thermo had some scale up there.
Catalent acquired Delphi, etc. So it sounds like the demand/supply -- this equilibrium continues here. Any early feedback on sort of customer traction?
Carl Hull -- Chief Executive Officer
Yes. This equilibrium is definitely still there and perhaps even growing based on the number of programs that are out there. Our customer reaction has been extremely positive to the capability to produce the plasmids for integrated program. We have a couple of different and very exciting programs that we're in sort of the mid-stages of negotiation over to actually provide the soup-to-nuts capabilities that we had anticipated in the first place.
So I'd say it's all tracking as expected or better.
Tejas Savant -- Morgan Stanley -- Analyst
Got it. Very helpful. Thanks so much for the time here this evening, and congrats on the quarter, guys.
Kevin Herde -- Chief Financial Officer
Thanks.
Carl Hull -- Chief Executive Officer
Thank you.
Operator
Thank you. Our next question comes from Matt Sykes of Goldman Sachs. Your line is open.
Matt Sykes -- Goldman Sachs -- Analyst
Great. Thank you. Congrats on the quarter, and thanks for taking my question. My first question was just regarding the non-COVID-related mRNA therapy in vaccine work.
You guys talked a little bit during the IPO about other programs you're involved with. I'm just curious in terms of the number of those programs or the growth that you've seen there, how can we think about that non-COVID-related mRNA therapy and vaccine work that you guys are doing?
Carl Hull -- Chief Executive Officer
Sure. Look, I think the pipeline there is growing, and we're seeing a resumption of the programs that had been delayed due to the pandemic at various points last year. So we're working with our customers to support the need for additional infectious disease but non-COVID vaccines. We expect to see those programs accelerate here, benefiting from the mRNA COVID work that's being done today.
I believe Pfizer mentioned recently in their conference call that they will use an mRNA platform for their seasonal flu vaccine program. Other examples include non-COVID therapeutic products. Many of these are for rare conditions or orphan diseases that can incorporate CleanCap. Examples of the disease states include OTC deficiency, glycogen storage disorders, acute lymphatic leukemia, etc.
So there's a bunch of those applications. I can't really comment much further on those partnerships unless the sponsors have disclosed publicly their own detailed production methods. That generally doesn't happen in this hypercompetitive field, but we have multiple of those programs continuing, and we see a number of them in the clinic already with the vast majority of those being Phase 1.
Matt Sykes -- Goldman Sachs -- Analyst
Great. That's very helpful. And just when you look at the '21 guide, you had mentioned that you're baking in the assumptions from a number of customers on the COVID vaccine side. I'm just wondering in terms of CureVac, how we should expect that to ramp up? Should it be sort of back half-loaded? Or is there some manufacturing taking place now that requires some purchase orders, increase in growth in purchase orders?
Carl Hull -- Chief Executive Officer
Let me think about how best to answer that. That's a little bit tough because it's probably getting into close details about the relationship. I would just say we have an excellent relationship with our partners at CureVac. We've been working with them for a number of years prior to the onset of COVID-19, and we have pretty good visibility to their program.
They're, obviously, from their public announcements, accelerating those efforts. So I think it is totally fair for you to expect to see impact from CureVac's efforts in the first half of this year. And if it scales anything like the relationship with Pfizer and BioNTech, then you will see that continue to accelerate in the back half of the year and beyond.
Matt Sykes -- Goldman Sachs -- Analyst
Thanks for that. And just my last question on biologic safety. You guys have a pretty good competitive advantage in terms of the breadth of your generic test kit and far above what some of your competitors have. I'm just wondering, have the competitive dynamics changed at all in that over the past few quarters? Or do you still find yourself in a pretty good position with that generic test kit?
Carl Hull -- Chief Executive Officer
No. They haven't changed one iota. We're continuing to see strong growth in that business. And as you can imagine, a lot of the new therapeutic programs that are targeting COVID-19 themselves are now spooling up and utilizing our product based on legacy relationships.
So it seems to be in a good spot.
Matt Sykes -- Goldman Sachs -- Analyst
Great. Thanks very much. Appreciate it.
Carl Hull -- Chief Executive Officer
Thank you, Matt.
Operator
Thank you. Our next question comes from Brandon Couillard of Jefferies. Your line is open.
Brandon Couillard -- Jefferies -- Analyst
Hey. Thanks. Good afternoon.
Carl Hull -- Chief Executive Officer
Hey, Brandon.
Brandon Couillard -- Jefferies -- Analyst
Carl or Kevin, as we think about the '21 outlook, can you help us with the phasing in terms of the first half versus the second half in terms of dollars? Should we assume a fairly linear progression through the year? And what would be the most important upside or downside variables that we should consider that might steer you toward the low or high end of the revenue outlook?
Carl Hull -- Chief Executive Officer
Yes. I think Kevin has got the best perspective.
Kevin Herde -- Chief Financial Officer
Yes. I think from a -- as we said in our prepared remarks, I think we're looking at the first quarter, up 30% to 35% sequentially from Q4 on total revenues. I think the business can get a little choppy as we start to go out. So I think we're going to keep our quarterly gating at that level for now.
Certainly, as it relates to CleanCap, we had a solid fourth quarter, but it will be moving up meaningfully in the first quarter, but we don't see the first quarter of 2021 being the largest quarter for CleanCap at this stage either. So you have to take that into account when looking at the range that we're giving for the CleanCap for COVID vaccine customers that we put in our prepared remarks. And that's kind of where we're going to stop as far as the quarterly gating at this stage.
Brandon Couillard -- Jefferies -- Analyst
Gotcha. And then on the plasmid DNA for understanding, it's still very early into the launch. But I'm curious, how would you measure success here near term? And given the huge supply/demand imbalance, are you already thinking about adding additional capacity here? And could you speak to kind of the revenue potential with the three suites that you just recently brought online?
Carl Hull -- Chief Executive Officer
Yes. Well, look, you know we're pretty conservative as we project. So we have not baked in a lot of plasma DNA-only revenues into our 2021 numbers. So I think it's fair to think of that as an area of potential upside as time develops.
But I'm going to measure success by capacity utilization, how many jobs do I have, and how occupied are the suites. That's how we'll look at it. And I think realistically, given the initial indications of interest, we are spooling up jobs and performing jobs as we speak, and that's the measure of success. So it just tells us that all the things that everyone has heard about shortages of plasma continue to be true, and when you see investments like Catalent making -- and Delphi just confirms that further.
Brandon Couillard -- Jefferies -- Analyst
Super. Thank you.
Carl Hull -- Chief Executive Officer
Thank you.
Operator
Thank you. Our next question comes from Matt Larew of William Blair. Please go ahead.
Carl Hull -- Chief Executive Officer
Hey, Matt.
Matt Larew -- William Blair -- Analyst
Hi. Good afternoon, guys. Carl, wanted to follow up on your commentary around M&A. As you think about how rapidly this market is progressing and just how much bioprocessing demand is accelerating, how do you balance the idea of building capability organically like plasmid that maybe it leverages your existing infrastructure but it might take some time to sail to maturity versus adding something a little more established really in the way you've built this business with TriLink, Cygnus, Vector Labs, etc.?
Carl Hull -- Chief Executive Officer
Yes. That's a great question. Eric, do you want to take a shot at that?
Eric Tardif -- President -- Analyst
Yes. Sure. I'd be happy to. So I think as we've told you and as we've discussed on the road in the past, I think our activities in M&A have a lot to do with shoring up our strategic capabilities and really solidifying our position primarily in M&A -- in mRNA rather, and then followed by biologics and then protein detection.
And so we look very much at our capabilities and what we need to fill that pipeline and ultimately be able to provide a complete service offering and product offering to our customers. We obviously do the build versus buy analysis, and we absolutely factor in time to market. But in addition to that analysis, it really is about finding those differentiated capabilities out of the market that, frankly, we couldn't build ourselves. When it comes to just pure capacity, we certainly look at acquiring capacity and we look at building capacity, that's much more of a build versus buy.
But the majority of our M&A activity is centered on strategic moves that shore up our capabilities.
Matt Larew -- William Blair -- Analyst
Yes. That makes sense. And then, obviously, we spent a lot of time talking about the ramp-up in infrastructure and manufacturing capacity. But just curious as you're thinking of 2021, how are you thinking about ramping up the spend in terms of customer support, customer engagement, building out a team to support, obviously, all of this increased demand that you're seeing? And then maybe, Kevin, to the extent you can help put any numbers around that, that might be helpful, too.
Carl Hull -- Chief Executive Officer
Yes. I'll just offer a first comment and then turn it over to Kevin. We certainly see the need to stay in close, close touch with our customers throughout this period of hyper expansion. Their needs are changing day to day, so their forecasts are changing day to day.
And we have to be on top of that so that we can be that trusted partner that they need right now. We don't want to be the squeaky wheel in anybody's supply chain. So we are expanding the resources that we have in all those areas: marketing, customer support, etc. We will spend more time on voice of customers, about what customers' desires are.
We think there's some obvious areas that we can and have been expanding in based on customers' needs already expressed to us, but we want to get better and tighter with them in the very near future. So that will happen during 2021. Kevin?
Kevin Herde -- Chief Financial Officer
Yes. I think we continue to see SG&A expenses increasing on an absolute basis for some of those investments, but certainly less than revenue growth. I think we'll see them in the mid to high teens for 2021 with some specific increases within marketing, as Carl just talked about, to really inform some potential R&D decisions as well, and certainly, with regards to increasing to support the public company costs that we'll have for a full year in 2021. Now we're still relatively light on R&D expenses as a percentage of revenue.
And I think the further input from our marketing organization, the voice of the customer, and working with some of our scientists will help to define some programs there that we hope to invest inorganically as well going forward.
Matt Larew -- William Blair -- Analyst
OK. That makes sense. Thanks, guys.
Carl Hull -- Chief Executive Officer
Thank you.
Operator
Thank you. Our next question comes from Catherine Schulte of Baird. Your line is open.
Catherine Schulte -- Baird -- Analyst
Hey, guys. Thanks for the questions. First, you had a press release out last month about a new issue patent for CleanCap. Can you just talk through how you feel from an IP perspective and if you're seeing any new competitors coming to market with an increased excitement around mRNA-based vaccines and therapeutics?
Carl Hull -- Chief Executive Officer
Yes. That's an important point, Catherine. The newest patent that issued is our third patent here in the U.S. It covers multiple advancements on the proprietary CleanCap technology, and we think it further demonstrates our kind of scientific leadership position here in figuring out novel ways to enable this co-transcriptional capping of mRNAs.
So it's turned out that's important all of a sudden, and it's turned out we've got a very good solution that meets the customers' needs there as they scale up some of these incredibly large manufacturing operations for mRNA. So we're feeling pretty good about it, and we believe that the IP would encourage people to come to us first. And that, in fact, is what's happening.
Catherine Schulte -- Baird -- Analyst
All right. Got it. And then on the M&A side, when you have the type of adjusted EBITDA margins that you do, it'd be hard for an acquisition to not be margin dilutive. Can you just walk us through kind of what those financial requirements are when you're looking at an asset and the type of leverage that you would be comfortable with?
Carl Hull -- Chief Executive Officer
Sure. Eric, you want to do that one?
Eric Tardif -- President -- Analyst
Yes. For sure. And look, you're right that we have margins that are hard to beat, and it's hard to find M&A targets that would be accretive to our margins. Certainly, I think we don't really look at the margin as a calculation when we're doing the math.
We're looking at return on invested capital, for example, and the impact on our earnings over time. So it's not really a margin percentage calculation that we do. We are very mindful of keeping our margins where we are, but I think really our target right now is on acquiring strategic assets rather than trying to do financial modeling or financial engineering by acquiring assets. So we have great organic growth.
We've got great margins. Really the focus in M&A is on strategic capabilities. And in terms of the leverage, Kevin, you might want to address that one.
Kevin Herde -- Chief Financial Officer
Sure. I mean with our net debt, just over $300 million in our projected adjusted EBITDA for 2021, that puts us about a one times net leverage for the -- looking forward to 2021. Obviously, that's something we're very comfortable with. We certainly feel we can take on board, if needed, for the right asset and also with cash on hand and our immediate liquidity with our undrawn revolver.
We like to be in a position to assess and act quickly, either some more organic investments in our product lines or through M&A. So we like the flexibility that our balance sheet affords us.
Catherine Schulte -- Baird -- Analyst
Great. Thank you.
Carl Hull -- Chief Executive Officer
Thank you.
Operator
Thank you. Our next question comes from Erin Wright of Credit Suisse. Your line is open.
Erin Wright -- Credit Suisse -- Analyst
Great. Thanks. So on CleanCap, again, you mentioned the high visibility on the CleanCap revenue, but I'm just trying to frame maybe the level of conservatism in the guidance or other factors that you may be considering relative to what's been publicly disclosed out there from Pfizer and others. And has there been any sort of dilution or other factors that would help us reconcile with those numbers? And just to clarify, does your guidance assume any meaningful contribution from relationships outside of Pfizer COVID vaccine for CleanCap?
Carl Hull -- Chief Executive Officer
OK. Sure. Let me see if I can hit those maybe in reverse order. Yes, there are other relationships outside of Pfizer CleanCap.
So a considerable number of them, in fact, and they do contribute materially to our estimates for the full year. And you are right that we do tend to be conservative when we put together our forecast, but we don't sandbag intentionally. We just are realistic and gimlet-eyed about what do we know, what is our degree of probability of confidence in that particular projection, and what could go wrong. And we sort of go through a fairly systematic way of digesting all of those data points and coming up with a combined forecast.
You won't see us putting out something that's moon in the stars that we have an area chance of meeting. But at the same time, we think we're being realistic based on what we know today. Now the one qualifier I would offer to you is that the situation does change. Sometimes, it seems like on a daily basis.
So our customers are figuring out what they need as they go. And I think as you could imagine, with the complex supply chains that are being -- multiple supply chains that are involved here, a customer is looking at a particular problem being constrained and gives all their other vendors' projections based on that constraint being in place. Once they fix that constraint, they rethink it and look at it and move on to what the next problem child is. And our objective is not to be that problem child.
Erin Wright -- Credit Suisse -- Analyst
OK. That's fair. And then you mentioned 2022 and your remarks is potentially shaping up nicely here. What are you referring to on that front? Is it largely COVID-related work or outside of COVID or across the board? I'm curious how you're seeing things shape up on that front.
Carl Hull -- Chief Executive Officer
Yes. It is two elements. One is the COVID-related work, and that just reflects the growing sentiment that there will be repeat vaccinations needed and that they will be enduring. So I think that gives us a greater degree of confidence in what the 2022 opportunity may well be versus what was known even as recently as four months ago at the time of the IPO.
The second contributor there is just our better understanding of the therapeutic pipeline. These resumed programs and the time line that these resumed programs would be on and a bunch of that because, obviously, these development time lines are not COVID, super accelerated. Those look like they come into play significantly in 2022 as well.
Erin Wright -- Credit Suisse -- Analyst
OK. Great. Thank you.
Carl Hull -- Chief Executive Officer
Thank you.
Operator
Thank you. Your next question comes from Dan Brennan of UBS. Your line is open.
Dan Brennan -- UBS -- Analyst
Great. Thank you. Thanks for taking the questions. I guess the first question was, I know it was asked earlier, what is your capacity for doses on COVID CleanCap? Did you disclose that earlier in the call?
Carl Hull -- Chief Executive Officer
We did not. Kevin indicated that we feel comfortable that our ability to produce and support over $1 billion in annual revenue on CleanCap is -- we're comfortable with that.
Dan Brennan -- UBS -- Analyst
Got it. OK. And then kind of back to '22, if you don't mind. I believe when we were looking out at the time of the IPO, we were thinking or the company was thinking about an annual dosing regimen in the out years, which is, I guess, where we're getting centered on now today with all the variants out there.
So maybe just another follow-up on the '22 outlook. So when you talk you're pleased with how things are progressing, could you give us any sense about some of the committed orders may be in hand or just pleased? It's hard to frame what pleased would mean given the range of outcomes that we could see in '22. So without giving a specific number, just trying to get directionally how we think about that '22 outlook.
Carl Hull -- Chief Executive Officer
Yes. Look, that's a possible one. Realistically, we're not projecting a specific variant becoming the dominant on the globe, and now we know that there's going to have to be a new vaccine by x date. But we are realizing how fast the rollout of the existing vaccines is going or not going depending on where you are.
We're recognizing then the delta at the end of -- people who haven't yet been vaccinated or completely vaccinated and then thinking about the number of potential doses that could come from a change being required. And those changes are breaking down into one of two areas. I kind of alluded to it. One is a true modification of the underlying vaccine sequence.
And there, it looks like if you see a variant that you have to change for, the regulators globally are going to have you on an expedited path to get that product authorized and into people's arms. So that's one element of it. And then the other elements are or the other approach is as Pfizer and BioNTech just announced their study of the impact of yet a third dose. So initial dosage with two boosters, what does that do to your immune response to variants? And those are the things that are driving potential demand in 2022 and beyond.
Dan Brennan -- UBS -- Analyst
Great. And then maybe you talked about the tremendous interest, I think you called it the transformation just over in the mRNA class, just given the success so far of the mRNA vaccines. Could you give us a sense of how we should be thinking about, A, just your base nucleic acid non-COVID business in '21? Like what's kind of baked in there? And then B, if we think about like what this opportunity beyond '21, how would you characterize kind of a steady-state normalized growth rate for the non-COVID-related opportunity at mRNA?
Carl Hull -- Chief Executive Officer
Kevin, do you want to take a shot at that? Or you want me to?
Kevin Herde -- Chief Financial Officer
Yes, Carl. I think when you look at our business and you look at the midpoints of our guidance, particularly given the midpoint of the COVID-19 vaccine CleanCap-related revenue, you see the remaining business growing roughly 20%, and that's across the three segments excluding the impact from the COVID vaccine virus and CleanCap. And I think that's very consistent with some of the underlying market trends that we've been seeing, particularly where we performed in biologics and then in nucleic acid production, and certainly, the protein detection business being a low single-digit grower from a market perspective.
Dan Brennan -- UBS -- Analyst
And that 20% because I know historically, they're not -- in the nucleic acid, business grew 30% in '17 and 26% -- 30%, so I mean the growth rates certainly have been above that level. I'm just wondering, as we look out, given the excitement and efficacy and success so far of mRNA, just how we might think about without giving a specific number, just how do we think about this transformation or opportunity and what it means for Maravai?
Carl Hull -- Chief Executive Officer
Well, look, I would say this, that I think the 20% in the rest of the business is a blend of the three different units that Kevin was talking about. And when you look at the historical numbers, you do have to remember that there was CleanCap in those numbers, albeit not for COVID-related purposes. So it's also a little bit of apples and oranges. I would say this that we've thought about our SAM pretty carefully and spelled that out at the time of the IPO and how large that market is.
And I do think in the broader oligo nucleic acid business that we would expect growth rate outside of some of this stuff. Could be in the mid-20s, and I think we've come up with a 28% SAM increase. That may have included CleanCap, but it will be a little bit higher than the other areas.
Dan Brennan -- UBS -- Analyst
Great. Thank you.
Carl Hull -- Chief Executive Officer
Thank you. Appreciate it.
Operator
Thank you. Our next question comes from Michael Ryskin of Bank of America. Your question, please.
Michael Ryskin -- Bank of America Merrill Lynch -- Analyst
Hi. Thanks for taking the question. Thanks for squeezing me in. I want to ask just one sort of big picture one at the end.
A lot of the topics have been covered, but I want to go back to sort of CleanCap broader adoption and some of the longer-term growth opportunities in the space. I mean if we -- obviously, CleanCap, you're already working with a number of leading pharma and biotech customers: Pfizer, BioNTech, CureVac, and a number of others you've disclosed. But there are other prominent leaders in mRNA therapeutics on utilizing the technology. So I'm just wondering, over the last three, six months as Pfizer, BioNTech success in the vaccine program has become more and more prominent, has gotten a lot more attention, are you able to take any steps in terms of penetration into some of these other customers? I guess in other words, I'm just wondering on whether CleanCap will be the dominant capping method for future programs even beyond your existing customers.
I realize it's a very long adoption cycle with new technology, but I'm just curious what your ability to penetrate into that basis then.
Carl Hull -- Chief Executive Officer
Yes. That is a very important point. Look, we have seen a number of new customers come to us early in their own therapeutic development programs now because of our involvement in some of the vaccine-related work that's ongoing and has caught them early. So I think there's a greater market awareness of the benefits of utilizing CleanCap as part of your early phase work, and we are aggressively marketing our capabilities to companies early enough so that it's not a disruptive change to their own plans and methods.
Now in fairness, the other side of that is anybody who's making COVID-19 vaccines using mRNA and if they're using enzymatic capping, which is the alternative method here, they're not going to change to CleanCap overnight. It would be a reregistration and a very, very big change at a time when nobody wants anything to change just so they can keep up with demand. So we're not expecting to see vaccine programs change in methodologies either toward us or away from us.
Michael Ryskin -- Bank of America Merrill Lynch -- Analyst
All right. Thank you.
Carl Hull -- Chief Executive Officer
Thank you. Appreciate it. Yes. We have time for one more question I think.
Operator
OK. Our next question comes from the line of Dan Arias of Stifel. Your line is open.
Carl Hull -- Chief Executive Officer
Hey, Dan.
Dan Arias -- Stifel Financial Corp. -- Analyst
Hi, guys. Thanks. Hey, Carl. Thanks for getting me in here.
I just -- I wanted to ask about the capacity expansion in January. If I remember correctly, that was for CleanCap and small molecule. I'm just curious whether you found the need to sort of borrow from the small molecule side in order to get you where you needed to be for vaccines? Or were you able to build out on both there?
Carl Hull -- Chief Executive Officer
Yes. The lines that we use for CleanCap and other small molecule work are relatively fungible, so we can move them as demand requires. So we haven't robbed Peter to pay Paul on this one. The other thing that came online in the first quarter is the plasmid suite, which are entirely distinct from this.
Dan Arias -- Stifel Financial Corp. -- Analyst
Yes. OK. If I could sneak one more in.
Carl Hull -- Chief Executive Officer
Sure.
Dan Arias -- Stifel Financial Corp. -- Analyst
Last year, when we were going through the process, you had talked about being sort of locked in with six mRNA vaccine providers and that there were three additional ones that I think were just sort of sitting out there as potentials. It sounds like there could be others there. So wondering if you would just be sort of willing to update us on where that tally of firmly committed customers lies at the moment.
Carl Hull -- Chief Executive Officer
We think that tally is still representative of what's going on. And if we have material developments where there's a significant program that makes progress, we'd probably disclose that at a future point. But I would say no major changes right now.
Dan Arias -- Stifel Financial Corp. -- Analyst
OK. Very good thank you.
Carl Hull -- Chief Executive Officer
All right. Thank you very much. We appreciate it.
Operator
Thank you. At this time, I'd like to turn the call back over to Debra Hart for closing remarks. Madam?
Debra Hart -- Host, Senior Director, and Investor Relations
Great. Thank you. Thanks, everyone, for joining us today. I did want to let you know we'll be participating at the Cowen Healthcare Conference tomorrow, March 3rd, and we'll also be at the KeyBanc Capital Markets, Life Science and Med Tech Investor Forum on March 23rd.
Both presentations can be accessed via live or replay from the Maravai Investor Relations website. So feel free to contact me with any questions, and we look forward to updating you during the course of 2021. Thank you.
Operator
[Operator signoff]
Duration: 64 minutes
Call participants:
Debra Hart -- Host, Senior Director, and Investor Relations
Carl Hull -- Chief Executive Officer
Kevin Herde -- Chief Financial Officer
Tejas Savant -- Morgan Stanley -- Analyst
Matt Sykes -- Goldman Sachs -- Analyst
Brandon Couillard -- Jefferies -- Analyst
Matt Larew -- William Blair -- Analyst
Eric Tardif -- President -- Analyst
Catherine Schulte -- Baird -- Analyst
Erin Wright -- Credit Suisse -- Analyst
Dan Brennan -- UBS -- Analyst
Michael Ryskin -- Bank of America Merrill Lynch -- Analyst
Dan Arias -- Stifel Financial Corp. -- Analyst
