Q3 2024 Maravai LifeSciences Holdings Inc Earnings Call

In This Article:

Participants

Deb Hart; Head, Investor Relations; Maravai LifeSciences Holdings Inc

Trey Martin; Chief Executive Officer; Maravai LifeSciences Holdings Inc

Kevin Herde; Chief Financial Officer; Maravai LifeSciences Holdings Inc

Dan Leonard; Analyst; UBS Group AG

Justin Bowers; Analyst; Deutsche Bank Research

Matt Hewitt; Analyst; Craig-Hallum Capital Group LLC

Dan Arias; Analyst; Stifel Financial Corp

Presentation

Operator

Good afternoon, ladies and gentlemen, and welcome everyone to the Maravai Life Sciences third-quarter 2024 earnings conference call. (Operator Instructions)
I would now like to turn the call over to Deb Hart. Please go ahead. Thank you.

Deb Hart

Good afternoon, everyone. Thanks for joining us on our third-quarter 2024 earnings call. Our press release and the slides accompanying today's call are posted on our website and available at investors.maravai.com.
As you can see from our agenda on slide 2, Trey Martin, Chief Executive Officer; and Kevin Herde, Chief Financial Officer, are joining me today. Drew Birch, President of Nucleic Acid Production; and Becky Buzio, our Executive Vice President and Chief Commercial Officer will join the call for the question-and-answer session following the 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 information about those forward-looking statements and our use of non-GAAP financial measures.
Our GIST-issued press release provides reconciliations to the most directly comparable gap measures. Please also refer to Marvite's SEC filings for additional information on the risks and uncertainties that may impact our operating results, performance, and financial condition.
Now, I'll turn the call over to Trey.

Trey Martin

Thank you, Deb, and good afternoon, everyone. We appreciate you joining our call today. I'll give a quick recap of the third quarter and provide some commentary on the market dynamics we are experiencing. I'll then provide a few business updates and discuss our plans to acquire the DNA and RNA business of Officinae Bio.
Let's start with our third quarter results on slide 5. Today, we reported $65 million in revenue $13 million in total adjusted EBITDA, and a loss of $0.02 in adjusted fully diluted earnings per share. Our nucleic acid production, or NAP, segment had revenue of $50 million.
Biologic safety testing, or BST, had revenue of $15 million. Q3 results were slightly below our expectations, primarily due to a few customer-requested program timing shifts, muted demand in research and discovery products within our NAP businesses, and persistent softness in the global biologics market, which impacted our BST segment.
In our NAP businesses, we recently achieved a key milestone, celebrating our largest service bill to date at our Water Ridge site, consisting of 26 grams of mRNA material for a preclinical cell and gene therapy customer. This program was initially slated for completion during Q3, but was delayed by one week into Q4 at the customer's request. Therefore, only a portion of the service revenue was recognized in Q3 versus the full amount we had assumed in our forecast. We will recognize the remainder of the revenue related to this program in Q4.
This is an example of the way customers' clinical program timing can affect our service revenue realization. We also commenced our first customer bill that Flanders II, meeting another major milestone in our NAP segment. You'll see some photos on slide 6.
This program is for a cell and gene therapy customer using mRNA as an ex-Vivo tool to create the therapy. The engineering run is complete and work is underway, preparing for batch one of GMP during Q4. We remain committed to advancing the field by playing a key role in the development of mRNA-based in vivo gene editing, gene-edited cell therapies, protein replacement therapies, cancer vaccines, and infectious disease vaccines.
Flanders II codifies this commitment to our customers through Phase 3 and commercial production. The fact that this customer chose to be the very first in our new facility is a testament to their confidence in our team's capabilities, expertise, and commitment to high quality, and we are delivering on all fronts.
We built a robust funnel for GMP services for our Flanders II facility, and are excited to be underway producing our first revenue in Q3. In the near term, I would expect the revenue contribution from Flanders to be a bit lumpy as we scale up. Similar to the customer requested delay at Water Ridge in Q3, a Flanders II customer with a Q4 scheduled service build has requested to move the program to early 2025 due to clinical trial delays on their end.
Our enhanced commercial team is working diligently with our customer funnel to fill capacity in the near term. We're encouraged by research that shows improved biotech financing and healthy new program starts in the industry related to our NAP businesses. However, we continue to transition through a period of contracting mRNA clinical trial starts led by the steady annual decreases of new COVID mRNA vaccine and therapeutic clinical trials.
Let's turn to slide 7 to understand what I mean by that. The chart on the left side of the slide shows mRNA clinical trials initiated each year. As you can see, 2021 saw the highest number of trials initiated, but a very high percentage, 77% of those were related to COVID-19 vaccines and therapeutics. You can see those declined by about 20% each year for the past few years.
The good news is that during this timeframe, the non-COVID mRNA trials represented by the orange portion of the chart have steadily increased each year and are up 29% year to date through Q3. At some point, indication diversity will overcome the impact of the COVID-driven decline in starts, and we believe the COVID program proportional impact is nearly behind us.
We believe we are the innovation leader and well positioned to service the growing segments of mRNA therapeutics discovery and development. The right chart shows clinical trials initiated for guide RNA-mediated gene editing, which is an exciting emerging opportunity for us. This market has been primarily CAR-Ts using [lintoviral] delivery approaches. However, developers are increasingly choosing mRNA as the preferred cast delivery vehicle.
We can and do support this market from RUO to GMP inputs and with RUO to commercial scale production across Water Ridge and now Flanders II. As you can see, this market growth is far outpacing prior years, up 75% year to date through Q3. Gene editing is a market we're excited about as a driver for our future growth potential.
In both charts, this data reflects new program starts, not total active programs. Our research shows the total mRNA programs continue to increase, and we are now tracking close to 1,500 active programs. We will continue to focus on innovation to move the industry forward and build new revenue streams as a leading supplier, mRNA producer and raw material supplier.
In that regard, I'd like to highlight three areas on slide 8. Within our NAP business segment, we've introduced 21 new products here today and continue to drive innovation as a critical KPI for our return to growth strategy. We've expanded our Discovery mRNA synthesis services offerings with new custom sets of mRNA, providing flexible options that customers need for screening and hit to lead optimization.
This plate-based mRNA launch supports our efforts to enable and lead the field sets of up to 96 mRNA constructs. These custom mRNA construct libraries enable the testing of multiple candidate sequences with different combinations of five prime caps, modified NTPs, and poly A tails, all with industry-leading cost and turnaround times. This new service enables our customers to optimize the performance of their specific targets, accelerating their development, and improving the efficacy of life-changing mRNA-based therapeutics.
Notably this quarter, Alphazyme and TriLink collaborated to launch CleanScribe RNA Polymerase. The CleanScribe RNA Polymerase is a novel enzyme that catalyzes the in vitro transcription, or IVT, of a recombinant gene regulated by the T7 promoter.
During the IVT reaction, CSRNA can be produced as a byproduct and trigger undesirable inflammatory responses in the cells. The CleanScribe enzyme dramatically reduces double-stranded RNA formation during the IVT compared to wild-type T7 RNA polymerase, which is the current industry standard. This new product reduces double-stranded RNA by up to 85% and is positioned to help our customers develop safer, more potent mRNA therapeutics.
Furthermore, we and our customers have found that this product is a very natural and easy substitution into existing IVT protocols and does not require extensive rework or further workflow optimization to achieve the exceptional performance. This product's robustness, reproducibility, and double-stranded RNA reduction make it ideal for mRNA synthesis, self-amplifying RNA synthesis, RNA-pro preparation, and RNA construct development for additional studies. In addition to improving the final product, it further improves the economic and process advantages that already make co-transcriptional capping with CleanCap the preferred approach for producing mRNA.
Initial feedback on CleanScribe has been very positive. In fact, a top pharma customer shared that they saw a 50% reduction in double-stranded RNA in their self-amplifying IVT process. This impressed them so much, they planned to switch over to CleanScribe as their default enzyme for self-amplifying RNA production.
Alphazyme continues to work closely with TriLink and external partners to collaborate on the next generation of enzymes. As with CleanScribe, next generation enzymes have the potential to boost the efficiency, yield and cost effectiveness of mRNA manufacturing. And we are committed to being the innovation leader in this area.
Finally, we expanded our TriLink-owned IP around co-transcriptional capping technology with the issuance of an additional patent in the US. We now hold over 20 US and international patents on our CleanCap capping technology.
Let's turn to slide 9. We continue to foster key academic partnerships to enhance innovation and accelerate market adoption of the latest technologies. We currently have active research collaborations with nine top tier academic institutions, some of which are listed here. The most recent is our collaboration with the University of California San Diego. We believe investing in new product innovation and partnering with leading academic and industry partners is a key driver for creating long-term value.
Now let's turn to slide 10 and discuss the pending acquisition of Officinae Bio. We have signed a definitive agreement to acquire the DNA and RNA businesses of Officinae Bio. Officinae is a provider of precision DNA and RNA services through an AI-driven digital platform that automates and iteratively improves large and complex DNA assembly from oligos to gene fragments, mRNA synthesis, and downstream cell-based screening. The team includes bioinformatics and data scientists, developing end-to-end software and synthesis automation solutions, enabling the design-build test cycles for mRNA therapeutics candidate discovery.
During the discovery phase, customers need to be able to experiment and develop multiple constructs as they test to find the most promising candidate to advance to the next phase. Today, there are many barriers to efficiently and effectively moving through these phases, and Officinae has created a solution set that enables this process. Just as our Alphazyme acquisition expanded our offering for mRNA transcription tools and key enzymes, Officinae will enhance our mRNA offering for early phase discovery work.
The addition of the Officinae's front-end development and production expertise is expected to add complementary capabilities to Maravai's NAP product portfolio and allow us to offer our customers even more complete and timelier mRNA solutions. As has been the case with our past acquisitions, Officinae is a founder-led and comprised of an experienced team focused on cutting-edge science, bioinformatics, and software services.
We expect this acquisition will accelerate and de-risk our e-commerce roadmap, enable mRNA discovery offerings and portfolio attachment, and access differentiated mRNA design and bioprocess optimization capabilities to enhance our customer experience using AI and machine learning.
As many of you are aware, our TriLink Discovery business unit is focused on working with customers at the front end of the drug development funnel. TriLink Discovery includes all research use only products and services, including all reagents, our custom chemistry business, and MR&E manufacturing for screening and target discovery. This is where the majority of our TriLink customers are today in the discovery and preclinical stage and why this acquisition fits so well.
The Officinae front end ordering platform is expected to provide current customers with a home for construct design and integrates a full catalog of CAP and novel chemistries. We believe the addition of this e-commerce and AI offering will help our TriLink Discovery customers get to the next stage of development faster and more effectively with the best possible candidates.
We know our ability to provide end-to-end service from sequence to drug product is a resounding value proposition for customer's choice. With the acquisition of a Officinae, our enzyme portfolio expansion through Alphazyme, our TriLink Discovery products, and TriLink GMP capabilities, we can incorporate raw materials and production expertise into our end-to-end service and supply offering, which is totally unique in the industry.
Now, let's turn to slide 11 and highlight innovation within the biologic safety testing segment. Collaboration with the TriLink team, Cygnus launched the first kit in their new generation of DNA quantification products, the AccuRes kit. This residual host cell DNA quantification kit and all future kits in this portfolio include a probe-based master mix that contains TriLink's clean AMP dNTPs and the Hot Start Taq DNA polymerase. The assay has higher sensitivity and specificity than the industry standards and the kits will help biopharma manufacturers ensure drug safety and stability for their patients.
The Cygnus DNA Extraction Kit, which is sold separately, be used to isolate the residual DNA from any cell line. The resulting purified DNA can be quantified in its corresponding DNA amplification and quantification kit. The AccuRes Kit is the first of many products we have in development to grow our host cell DNA portfolio and we expect to launch two more products in this portfolio by the end of the year.
Like the AlphaZyme and TriLink launch of the CleanScribe RNA polymerase, this new product demonstrates collaboration between our brands as the Cygnus DNA extraction kits use TriLink's Cclean Amp technology.
Now, turning to slide 12. We've continued to evolve through what we knew would be a transition year in 2024. As we prepare for 2025, we believe we have innovative technologies, have built the right capabilities and infrastructure, and are in the right markets to position us to achieve long-term growth. We've expanded our market position throughout the year with the industry and academic partnerships, and look forward to welcoming the Officinae team when the acquisition closes. I remain excited about our future, our capabilities, and what we can achieve together with the mission to make a meaningful impact in improving human health through the next generation of medicines.
I'll now ask Kevin to provide details on our third-quarter performance and our updated guidance. Kevin?