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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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For the fiscal year ended December 31, 2022
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
Commission file number 001-39725
Maravai LifeSciences Holdings, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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85-2786970 |
(State or other jurisdiction of incorporation or
organization) |
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(I.R.S. Employer Identification No.) |
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10770 Wateridge Circle Suite 200
San Diego, California
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92121 |
(Address of principal executive offices)
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______________________________
Registrant’s telephone number, including area code: (858)
546-0004
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Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Class A common stock, $0.01 par value |
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MRVI |
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The Nasdaq Stock Market LLC |
Securities registered pursuant to section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned
issuer, as defined in Rule 405 of the Securities Act. Yes
x
No
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Indicate by check mark if the registrant is not required to file
reports pursuant to Section 13 or Section 15(d) of the Act.
Yes
o
No
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Indicate by check mark whether the registrant: (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports); and (2) has been subject to such filing requirements
for the past 90
days. Yes x No o
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate web site, if any, every
Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files).
Yes x No o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer” and
“smaller reporting company” in Rule 12b-2 of the Exchange Act.
(Check one):
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Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act.
o
Indicate by check mark whether the registrant has filed a report on
and attestation to its management's assessment of the effectiveness
of its internal control over financial reporting under Section
404(b) of the Sarbanes-Oxley Act by the registered public
accounting firm that prepared or issued its audit report.
x
If securities are registered pursuant to Section 12(b) of the Act,
indicate by check mark whether the financial statements of the
registrant included in the filing reflect the correction of an
error to previously issued financial statements. ▢
Indicate by check mark whether any of those error corrections are
restatements that required a recovery analysis of incentive-based
compensation received by any of the registrant’s executive officers
during the relevant recovery period pursuant to §240.10D-1(b).
▢
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Act).
Yes ☐ No x
The aggregate market value of the registrant’s voting and
non-voting common equity held by non-affiliates as of June 30,
2022, the last business day of the registrant’s most recently
completed second fiscal quarter, was approximately $3,121.1
million, based on the closing price of the registrant’s common
stock on the Nasdaq Global Select Market of $28.41 per
share.
As of February 21, 2023, 131,785,305 shares of the
registrant’s Class A common stock were outstanding and 119,094,026
shares of the registrant’s Class B common stock were
outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
The information required by Part III of this Report, to the extent
not set forth herein, is incorporated herein by reference from the
registrant’s definitive proxy statement relating to the Annual
Meeting of Shareholders to be held in 2023, which definitive proxy
statement shall be filed with the Securities and Exchange
Commission within 120 days after the end of the fiscal year to
which this Report relates.
TABLE OF CONTENTS
SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS
This Annual Report on Form 10-K contains “forward-looking
statements” within the meaning of the safe harbor provisions of the
U.S. Private Securities Litigation Reform Act of 1995. Investors
are cautioned that statements which are not strictly historical
statements constitute forward looking statements, including,
without limitation, statements under the captions “Risk Factors,”
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations” and “Business” and are identified by words
like “believe,” “expect,” “may,” “will,” “should,” “seek,”
“anticipate,” “intend,” “plan,” “goal,” “project,” “estimate,”
“likely,” or “could” and similar expressions.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, projections,
anticipated events and trends, the economy and other future
conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of our control. Our actual results and financial
condition may differ materially from those indicated in the
forward-looking statements. Therefore, you should not rely on any
of these forward-looking statements. Important factors that could
cause our actual results and financial condition to differ
materially from those indicated include those discussed under the
heading “Summary of Risk Factors” and “Item 1A. Risk Factors” as
well as those discussed elsewhere in this Annual Report on Form
10-K.
Any forward-looking statement made by us in this report is based
only on information currently available to us and speaks only as of
the date of this report. We undertake no obligation to publicly
update any forward-looking statement, whether written or oral, that
may be made from time to time, whether as a result of new
information, future developments or otherwise.
Part I.
Item 1. Business
Overview
Maravai LifeSciences Holdings, Inc. (also referred to in this
document as “Maravai”, “we”, “us” or “the Company”) is a leading
life sciences company providing critical products to enable the
development of drug therapies, diagnostics, and novel vaccines and
to support research on human diseases. Our customers include the
top global biopharmaceutical companies ranked by research and
development expenditures according to industry consultants, and
many other emerging biopharmaceutical and life sciences research
companies, as well as leading academic research institutions
and
in vitro
diagnostics companies. Our products address the key phases of
biopharmaceutical development spanning research to
commercialization and include complex nucleic acids for diagnostic,
vaccine and therapeutic applications, and antibody-based products
to detect impurities during the production of biopharmaceutical
products.

Our businesses principally address high growth market segments in
biopharmaceutical development. In particular, the field of cell and
gene therapy has emerged as one of the fastest growing treatment
modalities to address a host of human conditions. There are more
than 2,000 cell and gene therapies in development or launched and
sales in this category are expected to grow more than 5 times by
2027, according to industry consultants and management estimates.
Our portfolio offers key products for each stage of the cell and
gene therapy development lifecycle. For example, our messenger RNA
(“mRNA”) products are used in drug development to assist in the
production of immune-activating antigens; our CleanCap® technology
is used to stabilize mRNA and streamlines mRNA manufacturing; we
were one of the first companies to provide the essential modified
uridine, N1-methyl-pseudouridine triphosphate, for research
applications; our catalog mRNA products are frequently used by
lipid developers to test and validate new mRNA delivery platforms;
and our plasmid DNA products are used as templates for the
production of our ribonucleic acid mRNA products. Our
oligonucleotide and oligonucleotide supply products are included in
the supply chain of several diagnostic platforms. We also provide
biologics safety testing technology used to ensure the safety of
the biological drug manufacturing process and drug products.
Developers of therapeutics and vaccines, including cell and gene
therapies, comprise about 85% of our customer base.
Our proprietary capabilities and products underpin the value we aim
to provide to our customers. Among other capabilities, we are
experts in RNA and mRNA products, which are challenging and often
unstable molecules requiring significant chemical modifications to
ensure their stability and efficacy in our customers’ applications.
Notably, according to research commissioned by us in November 2021
consisting of over 55 interviews and in November 2022 consisting of
30 additional interviews with our current and former customers, our
competitors and industry experts focused across our two ongoing
business segments (the “Industry Analysis”), we believe CleanCap is
viewed as a leading solution to incorporate the five prime (“5’”)
cap into mRNA. CleanCap is a novel chemical approach to produce the
5’ cap analog, which, in addition to making mRNA more stable, aids
in protein production and helps prevent an unwanted immune response
to the mRNA. CleanCap had been incorporated into several mRNA
programs targeting immunization against the novel strain of
coronavirus, SARS-CoV-2 (“COVID-19”). These
programs included two commercial programs led by Pfizer in
partnership with BioNTech and one led by BioNTech in partnership
with Fosun Pharma, as well as the bivalent booster vaccine
developed by Pfizer in partnership with BioNTech to address the
Omicron strain of the virus.
In addition to these commercialized programs, CleanCap has been
incorporated into many earlier stage programs addressing COVID-19
that have not yet been commercialized. Additionally, the U.S. Food
and Drug Administration (“FDA”) issued policies on February 22,
2021 to guide medical product developers concerning the development
of products to address the future of variants of the COVID-19 virus
specifically covering vaccines and therapeutics. We believe this
guidance may streamline the future development and approval of mRNA
vaccines utilizing our products and that they would likely be
incorporated into customer regulatory filings as a
result.
We believe our CleanCap products have also been incorporated into
vaccine development programs from several of our licensed clients
for infectious diseases, including Influenza, lyme disease,
malaria, HIV, tuberculosis, shingles, rabies, yellow fever,
respiratory syncytial virus (“RSV”) and Zika.
We estimate our mRNA and CleanCap products have also been
incorporated in over 250 vaccine and therapeutic programs in
development as of December 31, 2022, including at least 60
programs that our mRNA CDMO services group manufactured the mRNA
APIs using CleanCap. In addition to infectious diseases, these
programs address a number of disease states, including ornithine
transcarbamylase deficiency, glycogen storage disorders, Alpha-1
antitrypsin deficiency, acute lymphoblastic leukemia, Hurler
syndrome, ovarian cancer and cardiovascular disease. These
therapeutic programs also use multiple therapeutic modalities,
including CRISPR/Cas-9, transcription activator-like effector
nuclease (TALENS), enzyme replacement therapies, allogeneic CAR-T
cells and base editing. Should one or more of these programs
proceed to commercialization, we believe we will continue to supply
our customers and our products will likely be incorporated in
customer regulatory filings.
mRNA is at the core of our capabilities. We developed our expertise
in mRNA with a belief in its potential as a therapeutic modality.
The first clinical trial for an mRNA therapeutic agent occurred in
2016. Now, more than
750
clinical trials are in the pipeline, principally focused on
vaccines against viruses and cancer vaccines. With the COVID-19
pandemic, mRNA has shown its potential for more rapid vaccine
design and manufacture when compared to traditional techniques
involving culturing inactivated virus to elicit an immune response.
COVID-19 has helped highlight the potential advantage of mRNA as a
treatment modality and directed significant resources to the
growing base of knowledge about mRNA. This knowledge is now being
directed at future vaccine programs addressing infectious diseases
as well as for therapeutic agents for a host of human diseases. We
are positioned to serve our biopharmaceutical customers in the
fast-growing field of mRNA across a range of clinical programs for
a variety of diseases.
Forming long-term partnerships with our customers is core to our
strategy. Today, we primarily serve our customers during the
product development and process development phases. During product
development, we collaborate with our customers to develop and
synthesize nucleic acids, which in some cases comprise the active
pharmaceutical ingredient (“API”) of our customers’ products in
development. We also provide our customers a host of chemically
complex and highly specialized raw materials. Process development
is a complex phase that establishes highly validated procedures and
determines the investment in facilities and equipment required to
bring biopharmaceutical products to market. These decisions impact
the viability of our customers’ products for the long term. During
process development, we provide enzyme-linked immunosorbent assays
(“ELISAs”) that reduce the risk posed by impurities and
contaminants in biological drugs, a critical step to ensure the
safety of the drug product.
While we do not provide products that are themselves regulated as
drugs or
in vitro
diagnostics, our customers frequently incorporate our products into
their highly validated products and processes. For example, we
provide oligonucleotides and antibody-based products used by
in vitro
diagnostic product manufacturers for their on-market products.
Because of the extensive validation required for these products,
these components are frequently purchased for the life of our
customers’ products and we believe they are unlikely to be
substituted. In addition, our analytical tools are used in the
design and development of manufacturing processes and often will be
used throughout the life cycle of our customers’ manufactured
products. Once our services or products are qualified by our
customers, we are written into regulatory documents and standard
operating procedures. As a result, our customer relationships
frequently span many years.
The nature of our products and their uses require that they be
manufactured by highly trained personnel in state-of-the-art
facilities following exacting procedures to ensure quality. As of
December 31, 2022, approximately 18% of our workforce have
earned advanced degrees and all receive rigorous training on our
procedures. We manufacture our nucleic acid products at our San
Diego, California facility (“Wateridge facility”). The Wateridge
facility was purpose-built to address our customers’ needs for
critical raw materials manufactured under certain good
manufacturing practices (“GMP”) conditions and APIs for
investigational use. Our raw material products are manufactured
following the voluntary quality standards of ISO 9001:2015. Our
GMP-grade raw materials follow ISO 9001:2015 standards, additional
voluntary GMP quality standards and customer specific requirements.
Our API products are manufactured following the voluntary quality
standards of ISO 9001:2015, the International Council for
Harmonisation’s GMP Guide, comparable GMP principles for the
European Union and customer specific requirements. We believe our
products are exempt from compliance with the current GMP (“cGMP”)
regulations of the
FDA, as our products are further processed or incorporated into
final drug products by our customers and we do not make claims
related to their safety or effectiveness. As of December 31,
2022, we had invested $90.9 million in our Wateridge facility.
Our other facilities are similarly designed for specific
applications with quality systems to match our customers’
requirements. All of our manufacturing facilities meet applicable
ISO standards.
We built our business through a combination of acquisitions and
subsequent investments in our acquired companies to grow their
commercial capabilities, upgrade and expand their research and
production facilities, deploy stringent quality systems, integrate
their back-office functions, and develop the personnel and
management to fuel continued growth. Today, we offer an integrated
portfolio that enables innovation across the biopharmaceutical and
academic markets. Mergers, acquisitions and strategic partnerships
that complement our capabilities in cell and gene therapy and
biopharmaceutical production remain core to our strategy. Our
strategy aims to augment our strong organic growth with the
addition of synergistic products and capabilities.
Our Portfolio and Capabilities
We provide products that support our customers’ needs from
discovery through commercialization of their vaccines, therapeutic
agents and
in vitro
diagnostic products. Our products are frequently incorporated into
our customers’ products, whether as research products or APIs used
in development or research products incorporated as raw materials
into on-market products. They may also be incorporated into the
manufacturing process itself. We are therefore a critical part of
our customers’ supply chain and they frequently seek to maintain
their supply relationship with us for the life of their products or
development programs.
Our products address our customers’ needs for nucleic acid
production and biologics safety testing, and our operations are
aligned to these two segments. Our products and the end markets
they serve are depicted in the following image:
Nucleic Acid Production (92% of Revenue for the Year Ended
December 31, 2022)
We are a global provider of highly modified, complex nucleic acids
and related products. We have recognized expertise in complex
chemistries and products provided under exacting quality standards.
Our core offerings include mRNA, long and short oligonucleotides,
our proprietary CleanCap mRNA capping technology, mRNA building
blocks and oligonucleotide building blocks. Our offerings address
key customer needs for critical components, from research to
GMP-grade raw materials and API manufacturing. We market our
nucleic acid products under the TriLink BioTechnologies® and Glen
Research brands.
The growth in our nucleic acid production business segment has been
fueled by the significant growth in biological drugs in
development, many of which are cell and gene therapies, and by the
rapid rise in mRNA vaccines. mRNA as a treatment modality has been
an area of acute interest for many years.
The success of COVID-19 vaccines has helped highlight the potential
advantage of mRNA as a treatment modality and significant
investments have been made industry wide to developing future mRNA
vaccines as well as for therapeutic agents for
a host of human diseases. We are positioned to serve our
biopharmaceutical customers in the fast-growing field of mRNA
across a range of clinical programs for a variety of
diseases.
We offer the following nucleic acid products: mRNA, RNA Capping
(CleanCap), oligonucleotides, oligonucleotide inputs, nucleoside
triphosphates, custom nucleic acid chemistry and plasmid
DNA.
mRNA.
mRNA is an intermediary molecule that translates the genetic
information stored in DNA into proteins. The genetic information
stored in DNA is transferred to mRNA in a cellular process called
transcription. This process occurs in the nucleus of cells. DNA, a
double stranded molecule, is unwound and copied as mRNA by the
enzyme RNA polymerase. mRNA is then transferred out of the nucleus
to the cytosol, a component of the cytoplasm of a cell, where it
serves as a blueprint for making cellular proteins by a
multi-component organelle complex called the ribosome.
mRNA has traditionally been a difficult molecule for vaccine and
therapeutic purposes. mRNA is inherently unstable compared to DNA
and is susceptible to degradation by ubiquitous enzymes called
RNases. mRNAs are also physically and chemically fragile and can
degrade at elevated temperatures and under shear forces that occur
during downstream manufacturing processes. We have developed
manufacturing processes that overcome many of these obstacles,
resulting in highly effective mRNA.
We develop and manufacture mRNA products to support vaccine and
therapeutic programs from pre-clinical development through and
including clinical phases, including scale-up and analytical
development services. The mRNA molecules may serve as APIs for
diverse applications, such as enzyme replacement therapies, gene
editing therapies and vaccines. We offer both research grade
material and material made under GMP conditions for early phase
clinical trials.
RNA Capping.
Within the mRNA category, we also offer our CleanCap products. Our
proprietary CleanCap analogs principally serve the mRNA vaccine and
therapeutics markets, including vaccine candidates in development
for immunizing against COVID-19. Cap analogs are a component of
mRNA that aids in protein production as well as in making mRNA more
stable inside cells. For mRNA to serve as a template to make a
protein, it requires a special cap at the 5’ end of the molecule.
The cap structure also affects the stability of the mRNA. Lack of a
cap can result in activation of the innate immune system, which can
affect the production of the desired protein or elicit undesired
biological effects. We offer a suite of CleanCap analogs that are
specifically made for therapeutics and vaccines. Based on the
Industry Analysis, we believe our cap analogs are critical features
of several mRNA vaccines in development.


Traditionally, the 5’ cap has been added in one of two ways. The
cap can be added post mRNA synthesis by an enzymatic process. This
enzymatic method has several drawbacks, including the high cost of
the capping enzymes as well as the need to perform additional
processing steps to the mRNA to remove enzymes and byproducts of
the capping reaction. While capping efficiency is usually high, the
extra processing steps typically result degradation and mRNA of
poorer quality. The second method is to add a synthetic cap analog
into the transcription reaction such that the mRNA is transcribed
and capped in a single step. Anti-reverse cap analog (“ARCA”) is an
example of a cap analog that is added to the transcription
reaction. This avoids the workflow challenges of the enzymatic
process, but typically results in lower yields.
Like ARCA, CleanCap is a synthetic, chemically-made mRNA 5’ cap
analog added to the transcription process in a single step. Unlike
ARCA, however, CleanCap results in significantly higher levels of
capping efficiency, resulting in very low levels of uncapped mRNA,
which in turn minimizes the risk of activation of the innate immune
system. In addition, CleanCap’s higher mRNA yields compared to ARCA
result in lower cost of goods. When compared to enzymatic capping,
CleanCap removes the
additional downstream purification steps required. We have
developed a suite of CleanCap analogs that are specifically
designed for therapeutics and vaccines. CleanCap is sold as a
stand-alone reagent or bundled with other mRNA
products.
We currently offer several variations of the CleanCap molecule,
serving the needs of mRNA and self-amplifying RNA developers.
CleanCap is in two quality grades, research use only for discovery
and development activities, and a GMP-grade for clinical and
commercial applications. CleanCap mRNA products represented 89% of
our nucleic acid production revenue for the year ended
December 31, 2022 (including the revenue from CleanCap
products).
Oligonucleotides.
The oligonucleotide product category supports broad customer
applications, including therapeutics,
in vitro
diagnostics, next generation sequencing (“NGS”) and CRISPR-based
gene editing. Most of our TriLink BioTechnologies oligonucleotide
products are custom manufactured DNA or RNA sequences, often highly
modified and produced as research grade or under GMP conditions for
use in development, clinical and commercial
applications.
Oligonucleotide Synthesis Inputs.
Our product offerings through Glen Research include reagents and
support supplies for DNA and RNA oligonucleotide synthesis,
labeling, modification and purification. We are a reputable and
trusted vendor with a large portfolio, quality brand, knowledgeable
technical support, and responsive customer service. In addition to
oligonucleotide synthesis service providers, our customer base
includes life science, biopharma, and diagnostic companies as well
as academic institutions and government organizations, all of which
internally manufacture their own oligonucleotide
products.
Nucleoside triphosphates.
Nucleoside triphosphates (“NTPs”) are the precursors to DNA and
RNA. They are composed of a nitrogen base bound to either ribose or
deoxyribose with three phosphate groups added to the sugar. We
manufacture NTPs that are used in polymerase chain reactions
(“PCR”), in sequencing reactions and in the manufacture of mRNA.
The NTPs can be unmodified, composed of the four standard bases, or
modified, with a base altered to enhance a particular biological
property, such as the ability to evade the innate immune system in
therapeutic applications. TriLink BioTechnologies NTPs are used by
customers in both research and clinical trial applications. Our
manufacturing capabilities for NTPs now includes both research use
and GMP-grade.
Custom Nucleic Acid Chemistry.
Through our acquisition of MyChem LLC in the first quarter of 2022,
TriLink BioTechnologies expanded its synthetic chemistry expertise
and added proprietary manufacturing processes allowing for the
highest purity NTP, amidite and custom nucleotide services. We
serve a diverse market of diagnostics and therapeutic developers
that require novel molecules that are otherwise unavailable on the
market. Typically, these molecules are initially manufactured in
small quantities, and then scaled to meet the need of larger
diagnostic platform or therapeutic applications once positive
candidates have been identified by the customer.
Plasmid DNA.
Unlike genomic DNA, which constitutes the chromosome, plasmid DNA
exists outside the chromosome and represents small circular
double-stranded constructs. Plasmid DNA is frequently used as a
vector for replicating nucleic acid products. Plasmid DNA is
integral to the production of mRNA, serving as the nucleic acid
template for the DNA-dependant RNA polymases that frequently are
used in the manufacturing of mRNA. Our plasmid DNA offering allows
us to ensure the quality and timeliness of the mRNA API
manufacturing campaigns that we service for our
customers.
Biologics Safety Testing (8% of Revenue for the Year Ended
December 31, 2022)
We provide products and services under the Cygnus Technologies®,
LLC (“Cygnus Technologies”) brand that ensure the purity of our
customers’ biopharmaceutical products, including biological drugs.
For over 20 years, the Cygnus Technologies brand has been
associated with products and services that enable the detection of
impurities present in bioproduction. Our biologics safety testing
products are used during development and scale-up, during the
regulatory approval process and throughout commercialization. We
are recognized globally for the detection of host cell proteins
(“HCPs”) and process-related impurities during
bioproduction.
Our customers in this segment manufacture a broad range of
biopharmaceutical products. These include monoclonal antibodies and
recombinant proteins, both as novel biologics and biosimilars, and
recombinant vaccines, including vaccines to prevent COVID-19 and to
treat cancer. We also provide products in support of the
development of cell and gene therapies. Recombinant vaccines and
cell and gene therapies rely on manufacturing of various viral
vectors produced using recombinant nucleic acid and cell culture
technologies. Viral vector manufacturing processes require rigorous
analytics, including testing for process-related impurities such as
HCPs, host cell DNA, purification leachates, growth media additives
and enzymes used in viral vector purification processes. Of all
process-related impurities, HCPs present the most complex impurity.
Per regulatory requirements, viral vectors used as a component of
CAR-T cell therapies or as gene therapies must be produced in
certain cell lines, purified and tested for the presence of host
cell proteins. All of the 15 existing FDA-and EMA-approved CAR-T
Cell and Gene Therapies use Cygnus Host Cell Protein ELISA kits for
HCP testing for commercial product lot release. Five of these 15
therapies were approved in 2022.
ELISA is the benchmark method for monitoring levels of
process-related impurities during the purification process and in
product release testing. The advantages of well-developed ELISA
kits include the ability to measure very low levels of
impurities in the presence of high amounts of drug product, without
requiring a high level of expertise to execute and interpret, and
are readily transferable across an organization from process
development to manufacturing and quality control bioanalytical
groups. Though relatively simple to run, these ELISA kits require a
high level of expertise to design, develop and
qualify.
Customers establishing biopharmaceutical manufacturing processes
may use off-the-shelf or generic HCP kits provided by manufacturers
like ourselves, or they may choose to design their own in-house
assays for their specific processes. Some customers may choose to
use generic assays early in development and migrate to
process-specific assays later. The trend in recent years has been
for customers to increasingly use generic assays throughout their
development pathway, relying on our expertise and the established
performance of our assays. If customers choose to develop
process-specific assays, we offer custom antibody production and
assay development as well as characterization services to meet
their needs.
Our comprehensive catalog of Cygnus Technologies HCP ELISA kits
cover 23 expression platforms and provides the specificity and
sensitivity to detect impurities with reproducibility, which
supports regulatory compliance. Our reputation for quality is
recognized by the industry and global regulatory agencies, with
Cygnus Technologies assays used as reference methods throughout the
industry and to support manufacturing and quality control of
commercialized biologics.
Our customers in this segment are biopharmaceutical companies,
contract research organizations (“CROs”), contract development and
manufacturing organizations (“CDMOs”) and life science
companies.
Cygnus Technologies product categories include HCP ELISA kits,
other bioprocess impurity and contaminant ELISA kits, viral
clearance prediction kits, ancillary reagents and custom
services.
HCP ELISA kits.
HCP ELISAs are kits used to detect residual proteins from the
expression system used in bioproduction. HCPs constitute a major
group of process-related impurities produced using cell culture
technology no matter what cell expression platform is used. HCPs
pose potential health risks for patients and the risk of failure of
safety endpoints for drug manufacturers. When present in the
administered product, even at low levels, HCPs can induce an
undesired immune response, interfere with drug efficacy and impact
drug stability. HCPs are a critical quality attribute for biologics
safety testing development and must be adequately removed during
the downstream purification process.
Other impurity and contaminant kits.
Products in this category include kits for measuring Protein A
leachate, which results from the affinity purification method used
for monoclonal antibody therapeutic agents; ELISA kits for
measuring additives in growth media, such as bovine serum albumin;
kits for measuring host cell DNA; ELISA kits to detect and quantify
residual endonuclease impurities in recombinant viral vector and
vaccine preparations: and ELISA kits to quantify residual AAV2,
AAV8, AAV9 ligands resulting from affinity purification method used
for adeno associated virus (AAV)-based gene therapies.
Viral Clearance Prediction kits.
In 2020, Cygnus Technologies introduced the MockV® Minute Virus of
Mice (“MVM”) kit, a novel, proprietary viral clearance prediction
tool that includes a non-infectious “mock virus particle” mimicking
the physicochemical properties of live virus that may be present
endogenously in the drug substance or introduced during
bioproduction. The kit enables manufacturers to conduct viral
clearance assessments easily and economically and to predict
outcomes in-house ahead of costly and logistically challenging live
viral clearance studies. In 2022, Cygnus Technologies introduced
MockV® RVLP Kit. This kit enables bioprocess scientists to quantify
the removal of Retrovirus-like Particles
(RVLPs) produced endogenously by Chinese Hamster Ovary (CHO) cell
lines during biopharmaceutical manufacturing. The kit includes a
highly purified and concentrated stock solution of RVLP, an actual
non-infectious retrovirus-like contaminant generated during CHO
production. In the early 1990s, global regulatory agencies such as
the FDA realized the prevalence of this particle and became
concerned about the retroviral safety of CHO-derived
biopharmaceuticals. Since then, the biopharmaceutical industry has
relied on CROs to propagate Xenotropic Murine Leukemia Virus
(XMuLV) as a model retrovirus to demonstrate effective clearance.
With the availability of the MockV® RVLP Kit, biopharmaceutical
companies can now independently assess the removal of the original
retroviral particle of regulatory concern, derived directly from
CHO cells.
Ancillary reagents.
These products include antibodies, antigens, sample diluents and
other auxiliary products necessary to optimize applications for
customer processes.
Custom services.
We provide process-specific antibody and ELISA development,
qualification and maintenance services. In addition, we have
pioneered advanced orthogonal methods including antibody affinity
extraction (AAE™) and mass spectrometry for HCP antibodies coverage
analysis and HCP identification, which we provide as custom
services.
Our Competitive Strengths
We believe we are a leader in providing nucleic acid products and
biologics safety testing products and services to biopharmaceutical
customers worldwide. Our success is built on the ability of our
proprietary technologies and products, provided under exacting
quality standards, to reliably serve our customers’ needs for
critical raw materials.
Leading Supplier of Critical Solutions for Life Sciences from
Discovery to Commercialization
We seek to be an important component of our customers’ supply chain
by providing inputs that are central to the performance of their
products and processes throughout the product lifecycle. By
collaborating with customers early in the development phase, our
products frequently follow our customers’ development path to
commercialization and are likely to be incorporated as raw
materials in their on-market products and processes. Our
decades-long experience and track record, coupled with our ongoing
investment in facilities and quality systems, allow our customers
to rely on us for their critical products. Our approach is to be a
trusted partner throughout the life cycle of our customers’
products.
Innovation, Proprietary Technologies and Expertise Underpin Our
Portfolio
Our expertise in complex chemistries leads customers to seek our
collaboration in designing complex products that meet high
performance expectations. Based on the responses to the Industry
Analysis, we believe the solutions we provide, in many cases,
cannot be provided effectively by our competitors. In certain
cases, like our CleanCap technology, our know-how is backed by
intellectual property. In other cases, such as our HCP products,
our antibodies are proprietary and therefore can only be supplied
by us. We believe the proprietary nature of our expertise and
products solidifies our long-term customer
relationships.
Products with Outstanding Quality Performance
We believe our products stand out when compared to those of our
competitors’ because they present innovative solutions to customer
needs, as indicated by the responses to the Industry Analysis,
while providing reliable performance and quality. CleanCap, for
example, offers advantages over competing capping technologies in
yield, stability and safety. Our oligonucleotides address complex
chemistry challenges, which we believe few competitors can address.
The results of the Industry Analysis indicate that our HCP ELISA
kits have defined the market for impurity detection and we believe
they have become a
de facto
standard in biologics safety testing.
Trusted Brands
Our TriLink BioTechnologies, Glen Research, and Cygnus Technologies
brands are well known in their respective markets for consistent
quality and performance. This brand recognition has been earned
over decades. Our manufacturing processes, quality standards,
technical support and high-touch customer service ensure that we
maintain the reputation of our brands.
State-of-the-Art Manufacturing Facilities
Our biopharmaceutical customers manufacture their products to meet
stringent quality standards under strict regulatory guidelines and
expect their critical suppliers to meet their exacting
requirements. Our customers further expect that we have the
production capacity to meet their needs in a timely manner. As of
December 31, 2022, we had invested approximately
$90.9 million into our flagship Wateridge facility and its
five dedicated manufacturing suites to produce materials under GMP
conditions, along with the required quality systems to meet
requirements specified by our customers. Additionally, this
investment in our Wateridge facility allows us to meet our
customers demand for our nucleic acid products,
including
CleanCap. We similarly invest in our other sites to ensure we meet
our customers’ expectations. Throughout 2022 we invested in
additional facilities that we expect to bring online operationally
in 2023, including 1) an additional facility in San Diego,
California to further support GMP-grade manufacturing and to
support customers into Phase II clinical trials and beyond, and 2)
a new state of the art facility in Leland, North Carolina to
further support the Biologics Safety Testing business. We believe
that the capacity to manufacture to stringent biopharmaceutical
standards is constrained within the industry and our ability to
meet this demand sets us apart from our competition.
Experienced Leaders and Talented Workforce
Our management includes experienced leaders with demonstrated
records of success at Maravai and other highly regarded industry
participants. In addition, as of December 31, 2022,
approximately 18% of our workforce have earned advanced degrees and
all receive rigorous on the job training. We believe the quality of
our personnel is critical to ensuring the collaborative,
long-standing relationships we maintain with many of our
customers.
Our Markets
We participate in two distinct market segments: nucleic acid
production and biologics safety testing, which, according to
industry consultants, together represented approximately $15.2
billion in annual spending in 2022. Of that combined market, we
estimate our addressable portion represents approximately $3.7
billion. Our businesses principally address high growth market
segments in biopharmaceutical development. In particular, the field
of cell and gene therapy has emerged as one of the fastest growing
treatment modalities to address a host of human conditions. There
are more than 2,000 cell and gene therapies in development or
launched and sales in this category are expected to grow more than
five times by 2027, according to industry consultants and
management estimates.
While we expect near-term declines in overall market demand for
COVID-related products, we expect to benefit from favorable
industry dynamics in our broader market segments and specific
growth drivers in our addressable market segments.
Biopharmaceutical customers are increasingly relying on outside
parties to provide important raw material inputs and services for
their clinical research and manufacturing, a development driving
growth for suppliers with unique capabilities, high quality and the
ability to manufacture at a relevant scale to support customer
programs. We believe that suppliers like ourselves, with this rare
combination of capabilities, proprietary products and the required
investment in manufacturing and quality systems, are benefiting
from rapid growth as biopharmaceutical customers seek to partner
with a small number of trusted partners.
In addition to the continued trend toward outsourcing, several
market developments should contribute to long-term growth in our
addressable market segments, including:
•Pivot
toward mRNA vaccines and therapeutics for non-COVID indications has
been accelerated in part by COVID-19.
The first two vaccines approved for use in combating the COVID-19
pandemic were mRNA vaccines,
including the vaccine developed by Pfizer and BioNTech which uses
our CleanCap product. Our CleanCap product is also incorporated
into the bivalent booster vaccine developed by Pfizer and BioNTech.
The mRNA platforms are gaining prominence as a result of their fast
development time, lower relative manufacturing costs and proven
safety profile. Pfizer and BioNTech are now developing a combined
COVID-19 and Influenza vaccine that has been placed into a
designation that can “fast-track” a regulatory decision by the FDA.
In addition to the COVID-19 vaccines, mRNA technology is being
investigated for a spectrum of other infectious diseases as well as
cancer vaccines, including personalized medicine vaccines. We
expect research in other mRNA vaccines to experience increased
growth as research conducted for COVID-19 diffuses more broadly
into other vaccines and therapies. RNA expertise is highly
specialized, and customers seek partners with our expertise to
provide these complex products. A small number of providers, like
ourselves, with a successful track record for COVID-19, can provide
this level of RNA capability.
•Rapid
growth in development of cell and gene therapies.
Five new cell and gene therapy approvals (Carvykti, Roctavian,
Upstanza, Hemgenix, Adstiladrin) were all granted FDA or EMA
approval in 2022 and have added clinical credibility to cell and
gene therapies. Our internal analysis, supported by third-party
research, projects that by 2027, 40-50% of the mRNA pipeline assets
will be for
in vivo
gene editing and
ex vivo
gene-edited cell therapies. We support the development of cell and
gene therapies by providing products used in gene editing and cell
therapy research. For example, our host cell protein assays are
used during the manufacturing of viral vectors and plasmid DNA.
Further, we participate by providing the critical high quality
synthetic guide RNA and mRNA that encodes for gene-editing enzymes,
such as Cas9 that are used
in vivo
gene editing and
ex vivo
gene-edited cell therapies.
•Large
and growing pipeline of protein-based
therapeutics.
In addition to cell and gene therapies, an increase in
protein-based therapies is driving the need for impurity testing
during process development and manufacturing from our Biologics
Safety Testing business. Classical biologics are evolving to be
expressed in
vivo
via mRNA. Our analysis suggests that therapeutic proteins and
protein replacement may represent as much as 25% of the mRNA
pipeline by 2027. We are well positioned to leverage our service
capabilities and deep understanding of mRNA biology to serve our
customers’ needs to express these large, complex, peptide-based
molecules.
Nucleic Acid Production Market
The nucleic acid production market includes the production and
synthesis of reagents for research and manufacturing of DNA and
RNA-based biologics. Nucleic acid production was an $11.0 billion
market in 2022. Market growth generally accelerated in recent years
until the middle of 2022 due to continued innovation in cell and
gene therapy, including mRNA therapeutics and synthetic biology
approaches, and particularly as a result of mRNA manufacturing of
COVID-19 vaccines.
The field of mRNA-based drugs and vaccines has advanced
dramatically within a few short years. Capacity to manufacture
these products when approved, however, remains in short supply.
Providers of technical expertise and manufacturing capabilities,
like ourselves, with the facilities and quality systems demanded by
biopharmaceutical customers, benefit from the demand created in the
mRNA category.
Biologics Safety Testing Market
The biologics safety testing market includes the detection and
clearance of downstream bioprocessing product-related and
process-related impurities. Biologics safety testing is a $4.2
billion market in 2022. We participate in the HCP and other process
related impurities and viral contamination segments of this market
for biopharmaceutical vaccine and therapeutics manufacturing. The
growth in this market is driven by continued growth of biologics
and biosimilars, viral vector manufacturing for rapidly-growing
CAR-T and gene therapy modalities, and increased outsourcing of
process development.
Our Strategy
Our customers strive to improve human health. Our goal is to
provide them with products and services to accelerate their
development efforts, from basic research through clinical trials
and ultimately to commercialization for therapeutics, diagnostics
and vaccines.
Supporting Biopharmaceutical Customers from Discovery Through to
Commercialization
Our customers include both emerging and established
biopharmaceutical leaders developing novel drugs, therapeutics,
diagnostics and vaccines. Emerging biopharmaceutical customers
frequently seek the support we can offer in our state-of-the-art
facilities under our stringent quality standards, with the
capabilities that result from the capital and process investments
we have made over the last several years. We are capable of
manufacturing reagents from research-grade to GMP-grade,
which
often exceeds the in-house capabilities of our pre-commercial
customers. The results of the Industry Analysis indicate that our
emerging and established customers also seek us out for our leading
capabilities in nucleic acid chemistries and process control
assays. We have expertise in complex chemistries, especially in
highly modified nucleic acids and mRNA, and we believe we are a
leader in applying these capabilities to the development of
vaccines and therapeutics. We further support our customers as they
transition from product development to commercialization by
providing critical raw materials for their drugs. A core component
of our strategy is the continued investment in facilities, quality
standards and products and services that allow us to support our
customers through the entire life cycle of their
drugs.
Developing Proprietary Technologies that Deepen our Relationships
with Our Customers
We believe we are experts in nucleic acids and our scientists aim
to develop proprietary enabling technologies that become integral
to our customers’ products. For example, CleanCap, our proprietary
chemical capping technology, has demonstrated its advantages in
terms of the stability of the associated mRNA and its efficiency in
protein production when compared to traditional capping
technologies. This efficiency has led biopharmaceutical customers
to employ CleanCap in their vaccine and therapeutic programs. As
those products proceed through development into commercialization,
we believe CleanCap will be a critical input in on-market vaccines
and therapeutics.
Forming Long-Term Partnerships for Critical Biopharmaceutical
Components and Process Tests
Our products are frequently incorporated into regulated and highly
validated therapeutic and diagnostic products and processes. Our
biopharmaceutical customers expect us to provide them with
consistent, high-quality products that meet narrow specifications,
and that we ensure their supply chain for such products for the
length of their programs. In many cases, we may be the sole source
of the products we provide. We therefore take seriously our
responsibility to our biopharmaceutical partners, and by extension
the patients they serve. Our emphasis on partnership generally
leads to long-term relationships with our customers.
Focusing Our Efforts on High Growth End Markets
While biopharmaceutical research and
in vitro
diagnostics markets are experiencing strong growth, we target the
highest growth segments within those markets. Our product portfolio
is well positioned to serve the biologic, cell and gene therapy and
mRNA vaccine and therapeutic end markets, which are currently
experiencing above-market growth. By investing in technologies at
the forefront of biopharmaceutical and
in vitro
diagnostics, we aim to remain focused on the highest-growth
applications.
Acquiring Leading Life Sciences Businesses and Supporting Their
Continued Development
We built our business by acquiring established and emerging
companies with strong scientific foundations in our target markets
and investing in their systems, processes and people to accelerate
their growth and expand their technologies. Going forward, we may
pursue strategic acquisitions that we believe meet, or could meet
after being acquired and expanded, the following
criteria:
•address
our core target markets;
•have
a demonstrated adherence to high quality standards;
•be
leaders in their market niche(s);
•have
differentiated or proprietary products and processes that provide
clear value to our biopharmaceutical and other customers;
and
•have
a track record of attractive rates of growth and compelling returns
on invested capital.
Our acquisition strategy is to invest significantly in our acquired
businesses. We strive to rapidly integrate their quality, human
resources, information and financial systems into our shared
services. All of our companies share a common enterprise resource
planning system, and we implement our financial controls and
reporting systems soon after acquisition. We seek opportunities to
invest in their facilities and personnel to provide an operating
foundation for growth. We also augment their commercial
capabilities through a combination of sales and marketing resources
dedicated to each business, supported by our global marketing
infrastructure.
We will continue to seek a balance between driving growth
organically and inorganically through acquisitions.
Commercial
We have relationships with the following categories of customers:
developers of therapeutics and vaccines, other biopharmaceutical
and life science research companies, academic institutions and
molecular diagnostic companies. Developers of therapeutics and
vaccines, including cell and gene therapies, comprise about 85% of
our customer base. Our biopharmaceutical customers include
startups, established biotechnology companies and large
pharmaceutical companies developing enzyme replacement therapies,
gene editing therapies,
ex vivo
therapies and vaccines.
Our commercial function includes direct sales, marketing, customer
service, technical support and distributor management. We serve
customers through direct sales in each business segment, with a
primary focus on our biopharmaceutical and large diagnostics and
commercial customers. We serve our academic customers via web,
email and phone ordering as well as through key partnerships where
our reagent products are included in their mRNA kits. We support
all customers with live technical support and customer
service.
We address customers outside the United States with a combination
of direct sales and distributors. We serve many of our
biopharmaceutical customers, especially in our nucleic acid
production segment, via direct sales worldwide. Our distributors
also sell our products in over 45 countries and provide customer
service and local sales and marketing.
Competition
We compete with a range of companies across our
segments.
Nucleic Acid Production
Within nucleic acid production, we compete with four primary types
of companies: (1) chemistry companies that create and produce the
basic monomers, amidites, and supports that go into the creation of
an oligonucleotide; (2) oligonucleotide manufacturers that
specialize in custom oligonucleotide development of varying
complexities and scales; (3) mRNA biotechnology companies that
create fully processed mRNA and specialize in custom, complex
orders; and (4) CDMOs that have the capability to accept work from
large biopharmaceutical companies and serve as the outsourcing
entity for the development and manufacturing of nucleic acid
products. However, it is important to note that CDMOs seldom offer
proprietary products.
For mRNA capping analogs, we compete principally with Thermo Fisher
Scientific, Aldevron (a subsidiary of Danaher), and New England
BioLabs, who offer alternatives to CleanCap with enzymatic capping
solutions. Many biopharmaceutical companies produce capping
solutions in-house using enzymatic or ARCA processes. However,
given CleanCap’s high yield and process efficiency, many customers
who previously insourced these processes have begun to partner with
us. Based on the Industry Analysis, we believe our products and
services are more effective than those of our competitors. Deep
scientific expertise, intellectual property protection and
specialty equipment serve as barriers to entry in this
space.
For our mRNA offerings, we compete with Aldevron Patheon, eTheRNA,
Lonza, Catalent, and Samsung Biologics, among others. Based on the
Industry Analysis, we believe we have a reputation for our
expertise in the RNA space with talented scientists who are
constantly pushing the frontier of RNA science. This scientific
expertise and the required high-cost equipment serve as barriers to
entry. In addition to our expertise, we believe our GMP cleanroom
manufacturing process differentiates us from
competitors.
For custom oligonucleotides, we compete with a number of
manufacturers. Custom oligonucleotide providers include those that
provide complex, highly modified oligonucleotides and those that
provide less complex offerings. In the custom oligonucleotide
space, complexity is based on the length of the sequence and level
of modification to the phosphate backbone. Large manufacturers like
Integrated DNA Technologies, Thermo Fisher Scientific and EMD
Millipore Corporation (“Millipore Sigma”) serve less complex
customer needs while we, LGC Biosearch Technologies and GenScript
Biotech Corporation serve more complex customer needs. In the
custom oligonucleotide market, we have a reputation for accepting
complex orders and delivering high purity products that reduce
researcher re-work and save money. Quick turnaround times and the
ability to produce at scale are essential requirements in this
segment.
In the oligonucleotide synthesis inputs market, we compete against
large distributor-manufacturers like Thermo Fisher and Millipore
Sigma while also serving them as customers. Our Glen Research brand
has a long history in this industry, which drives customer loyalty,
and has a reputation for high-fidelity technical service, focusing
on supplying and sourcing highly modified inputs for its
customers.
Biologics Safety Testing
For drugs in early development, we compete against other bioprocess
impurity kit providers such as BioGenes (“BioGenes”) or Enzo Life
Sciences (“Enzo”). Competitors generally offer fewer expression
platforms (generally between one and three)
compared to our offering of 23 expression platforms and over 75
different impurity detection kits. As a drug successfully moves
forward to validation and approval stages, a customer may either
continue with an off-the-shelf kit or they may begin the process to
develop a custom assay that is tailored to meet their specific host
cell and manufacturing process needs. During the entire drug
development process, and especially during this decision, we are
partners with the manufacturer and provide our expertise to help
them make the best bioprocess quality control and testing-related
decisions.
If a drug manufacturer continues with an off-the-shelf assay from
development to validation and approval, they will generally stay
with the incumbent kit provider due to the extensive validation
they have conducted. For custom assay development, our main
competitors are BioGenes, Rockland Immunochemicals and some CDMOs
and CROs with custom assay development capabilities. The trend in
recent years has been for CDMOs, CROs and large biopharmaceutical
companies to focus on core competencies and outsource host cell
protein assays or qualify off-the-shelf kits when
possible.
Licenses and Collaborations
Broad Patent License Agreement
We (through TriLink BioTechnologies) entered into a Nonexclusive
Patent License and Material Transfer Agreement with The Broad
Institute, Inc. (“Broad”) effective as of July 5, 2017, and
amended on September 29, 2017 (the “Broad Patent License
Agreement”). Broad, together with a consortium of educational
institutions (including Harvard University and the Massachusetts
Institute of Technology), owns and controls certain patent rights
relating to genome editing technology, including the CRISPR-Cas9
gene editing processes and have a licensing program for use and
commercialization of technologies and products covered by the
underlying patent rights. Under the Broad Patent License Agreement,
Broad grants to us a non-exclusive, royalty-bearing,
non-transferable and non-sublicensable, worldwide license under the
licensed patent rights to manufacture and sell products and to
perform certain
in vitro
processes or services on a fee-for-service basis, in each case,
solely as research tools for research purposes (excluding human,
clinical or diagnostic uses). We must use diligent efforts to
develop products, introduce products into the commercial market and
make products reasonably available to the public. We are obligated
to pay a mid-five figure annual license maintenance fee and
royalties in the range of 5% to 10% on net sales of covered
products and processes.
The term of the Broad Patent License Agreement extends through the
expiration of the last to expire claim of any of the licensed
patents. We are entitled to terminate the Broad Patent License
Agreement for convenience at any time on at least three (3) months
written notice, in which case we must continue to pay license
maintenance fees and royalties as noted above for the sale of
products that are not covered by the specific claims of the
licensed patent rights but are otherwise derived from such licensed
patent rights or from products covered by such licensed patent
rights. Broad may terminate the license for our uncured failure to
make payments, for our uncured material breach or if we bring a
patent challenge against any of the institutional rights
holders.
LSU Patent License Agreement
We (through TriLink BioTechnologies) entered into a Patent License
Agreement with the Board of Supervisors of Louisiana State
University and Agricultural and Mechanical College and Dr. Edward
Darzynkiewicz (collectively, “LSU”) effective as of July 7, 2010
(the “LSU Patent License Agreement”). Under the LSU Patent License
Agreement, LSU grants to us a non-exclusive, royalty-bearing
license under an issued U.S. patent and patents that claim priority
thereto, directed to mRNA capping technology to make and sell
reagents and kits for research use only (excluding use in humans or
for diagnostic or therapeutic purposes) in the United States. We
are required to use commercially reasonable efforts to
commercialize the licensed products throughout the life of the LSU
Patent License Agreement. We are obligated to pay a low four-figure
annual license maintenance fee and royalties in the range of 5% to
10% on net sales of licensed products.
We must pay royalties to LSU until the expiration of the last to
expire licensed patents. We are entitled to terminate the LSU
Patent License Agreement for convenience at any time on at least
sixty (60) days written notice, subject to paying in full all
amounts due up to the date of termination and cessation of any
exercise of the licensed rights thereafter. LSU may terminate the
license for our uncured failure to make payments or our uncured
material breach.
AmberGen Agreement
We (through Glen Research) entered into an Agreement with AmberGen,
Inc. (“AmberGen”), dated May 11, 2000 (the “AmberGen
Agreement”) under which AmberGen has appointed us the exclusive
distributor of AmberGen’s proprietary photocleavable product
offered under the name PC Phosphoramidite on a worldwide basis. We
are limited to selling the product for research use only and are
required to use good faith efforts to discontinue distribution to
buyers making use of the product than purposes other than
laboratory research.
We are entitled under the AmberGen Agreement to purchase product
from AmberGen at AmberGen’s cost to manufacture the product. On a
monthly basis, we are required to remit to AmberGen 50% of the
gross profits on product sales for which payments were received in
the preceding month.
The AmberGen Agreement was initially in effect for a five-year term
but is now in a series of automatic one-year renewal terms. Either
party may terminate the AmberGen Agreement on six (6) months
written notice or immediately for material breach of the other
party or, subject to a cure period, for certain bankruptcy-related
events.
BTI Biosearch Dyes Agreement
We (through Glen Research) are a party to a Commercial Supply and
License Agreement with Biosearch Technologies, Inc. (“BTI”), dated
June 29, 2004, as amended on November 8, 2004 (the “BTI Biosearch
Dyes Agreement”), under which BTI agrees to supply us with certain
BTI dyes and we are granted a worldwide, non-exclusive license to
sell certain BTI dyes and to use BTI’s product-related trademarks
to do so. The BTI dyes can only be sold for the customer’s internal
research and development use and inclusion in commercial kits or
any commercial application is prohibited unless the customer has
obtained a valid commercial license from BTI. The rights granted do
not include sales to customers for use in human
in vitro
or clinical diagnosis. We are required to pay a per unit price for
the licensed BTI products.
The BTI Biosearch Dyes Agreement was originally in effect for a
term of two years and is now in a series of annual year-to-year
renewals. Either party has the right to opt-out of such renewals
upon ninety (90) days’ notice prior to the next renewal. Either
party can terminate the agreement for convenience at any time on
six months’ written notice. Either party can terminate the
agreement for the other party’s uncured material breach or
insolvency.
Manufacturing and Supply
We occupy facilities in San Diego, California, Southport, North
Carolina and Sterling, Virginia.
Our Wateridge facility in San Diego is engaged in the manufacture
of reagents. The facility was designed and built by us in
conjunction with the building owner to contain fully functional
chemical and biological manufacturing operations from material
receiving to product distribution and has its own loading dock,
manufacturing gas delivery system, solvent delivery and waste
system, ISO 8 and ISO 7 designated customer manufacturing suites
and integrated building management systems for required site
control.
We continue to invest in our Wateridge facility with recent
expansions allowing for the manufacture of plasmid DNA and creation
of ISO Class 8 and ISO Class 7 clean rooms providing for
an expansion of the scale at which we can manufacture CleanCap and
NTPs, supported by a pilot plant for development of large-scale
manufacturing processes. This investment has allowed us to
substantially increase our capacity for nucleic acid production and
specifically CleanCap
meeting the demand from our customers without interruption or
constraints.
In addition to the Wateridge facility, throughout 2022 we invested
in an additional facility in San Diego. California (the “Flanders
San Diego Facility”) that we expect to occupy in 2023. The new
Flanders San Diego Facility will provide us with additional GMP
manufacturing capacity and provide us the optionality downstream to
manufacture materials beyond current quality requirements for mRNA
raw materials, including CleanCap. The Flanders San Diego Facility
will include the introduction of integrated manufacturing systems,
quality of water improvements from Reverse Osmosis De-ionized grade
water to WFI (“Water For Injection”), which is pharmaceutical grade
water, and other facility infrastructure investments to support
potential customer needs related to quality. These investments will
also support an additional increase to batch run sizes and overall
throughput.
In 2022, we secured additional office, warehouse and light lab
space in San Diego for the primary purpose to relocate our sales,
general and administrative employees. We also assumed a lease from
our MyChem acquisition and have repurposed the facility as a small
R&D lab.
Our Southport, North Carolina operations are engaged in the
manufacture and processing of antibody and HCP ELISA kits. The
operations include laboratory, manufacturing, bottling, shipping
and waste handling capabilities. In 2023, our Southport operations
will relocate to a new state-of-the-art facility in Leland, North
Carolina. This new facility more than doubles our operational
square footage to support current and future growth. The fully
customized design will provide room for a Mass Spectrometry Center
of Excellence and specialized cell culture facilities. It will
significantly increase our cold storage capacity while providing
other R&D, laboratory and automation upgrades. Extensive
process flow analysis has been incorporated into the facility
design to optimize and enhance both our manufacturing and kit
packaging operations.
Our Sterling, Virginia facility was designed to perform quality
control, aliquoting, packaging and shipping and houses the
appropriate space and systems.
Our supply chain relies on a network of specialized suppliers and
transportation companies. We regularly review our supply chain for
supplier quality and risks related to concentration of supply and
we take appropriate action to manage these potential
risks.
Government Regulation
We provide products used for basic research or as raw materials
used by biopharmaceutical customers for further processing, and
active pharmaceutical ingredients used for preclinical and clinical
studies. The quality of our products is critical to researchers
looking to develop novel vaccines and therapies and for
biopharmaceutical customers who use our products as raw materials
or who are engaged in preclinical studies and clinical trials.
Biopharmaceutical customers are subject to extensive regulations by
the FDA and similar regulatory authorities in other countries for
conducting clinical trials and commercializing products for
therapeutic, vaccine or diagnostic use. This regulatory scrutiny
results in our customers imposing rigorous quality requirements on
us as their supplier through supplier qualification processes and
customer contracts.
Our nucleic acid and biologics safety testing segments produce
materials used in research and biopharmaceutical production,
clinical trial vaccines and vaccine support products. We produce
materials in support of our customers’ manufacturing businesses and
to fulfill their validation requirements, as applicable. These
customer activities are subject to regulation and consequently
require these businesses to be inspected by the FDA and other
national regulatory agencies under their respective cGMP
regulations. These regulations result in our customers imposing
quality requirements on us for the manufacture of our products, and
maintain records of our manufacturing, testing and control
activities. In addition, the specific activities of some of our
businesses require us to hold specialized licenses for the
manufacture, distribution and/or marketing of particular
products.
All of our sites are subject to licensing and regulation, as
appropriate under federal, state and local laws relating
to:
•the
surface and air transportation of chemicals, biological reagents
and hazardous materials;
•the
handling, use, storage and disposal of chemicals (including toxic
substances), biological reagents and hazardous waste;
•the
procurement, handling, use, storage and disposal of biological
products for research purposes;
•the
safety and health of employees and visitors to our facilities;
and
•protection
of the environment and general public.
Regulatory compliance programs at each of our businesses are
managed by a dedicated group responsible for regulatory affairs and
compliance, including the use of outside consultants. Our
compliance programs are also managed by quality management systems,
such as vendor supplier programs and training programs. Within each
business, we have established Quality Management Systems (“QMS”)
responsible for risk based internal audit programs to manage
regulatory requirements and client quality expectations. Our QMS
program ensures that management has proper oversight of regulatory
compliance and quality assurance, inclusive of reviews of our
system practices to ensure that appropriate quality controls are in
place and that a robust audit strategy confirms requirements for
compliance and quality assurance.
Research Products
Our products and operations may be subject to extensive and
rigorous regulation by the FDA and other federal, state, or local
authorities, as well as foreign regulatory authorities. The FDA
regulates, among other things, the research, development, testing,
manufacturing, clearance, approval, labeling, storage,
recordkeeping, advertising, promotion, marketing, distribution,
post-market monitoring and reporting, and import and export of
pharmaceutical drugs. Certain of our products are currently
marketed as research use only (“RUO”).
We believe that our products that are marketed as RUO products are
exempt from compliance with GMP regulations under the FDCA. RUO
products cannot make any claims related to safety, effectiveness or
diagnostic utility and they cannot be intended for human clinical
diagnostic use. In November 2013, the FDA issued a final guidance
on products labeled RUO, which, among other things, reaffirmed that
a company may not make any clinical or diagnostic claims about an
RUO product. The FDA will also evaluate the totality of the
circumstances to determine if the product is intended for
diagnostic purposes. If the FDA were to determine, based on the
totality of circumstances, that our products labeled and marketed
for RUO are intended for diagnostic purposes, they would be
considered medical products that will require clearance or approval
prior to commercialization.
We do not make claims related to safety or effectiveness and they
are not intended for diagnostic or clinical use. However, the
quality of our products is critical to meeting customer needs, and
we therefore voluntarily follow the quality standards outlined by
the International Organization for Standardization for quality
management systems (ISO 9001:2015) for the design,
development, manufacture, and distribution of our products. Some
biopharmaceutical customers desire extra requirements including
quality parameters and product specifications, which are outlined
in customer-specific quality agreements. These products are further
processed and validated by customers for their applications.
Customers qualify us as part of their quality system requirements,
which can include a supplier questionnaire and on-site audits.
Customers requalify us on a regular basis to ensure our quality
system, processes and facilities continue to meet their needs and
we are meeting requirements outlined in relevant customer
agreements.
Active Pharmaceutical Ingredients (“APIs”) for Clinical
Trials
We provide APIs to customers for use in preclinical studies through
and including clinical trials. We hold a drug manufacturing license
with the California Food and Drug Branch of the California
Department of Public Health for manufacture of APIs for clinical
use and are subject to inspection to maintain licensure.
Manufacture of APIs for use in clinical trials is regulated under
§ 501(a)(2)(B) of the FDCA, but is not subject to the current
GMP regulations in 21 CFR § 211 by operation of 21 CFR § 210.
We follow the principles detailed in the International Council for
Harmonisation (“ICH”) Q7, Good Manufacturing Practice Guide for
Active Pharmaceutical Ingredients (Section 19, APIs For Use in
Clinical Trials) in order to comply with the applicable
requirements of the FDCA, and the comparable GMP principles for
Europe; European Community, Part II, Basic Requirements for Active
Substances Used as Starting Materials (Section 19, APIs For Use in
Clinical Trials). APIs are provided to customers under customer
contracts that outline quality standards and product
specifications. As products advance through the clinical phases,
requirements become more stringent, and we work with customers to
define and agree on requirements and risks associated with their
product.
Customers’ biopharmaceutical products early in their development
have a high failure rate and often do not advance through the
clinical stages to commercialization. Our customers are required to
follow regulatory pathways that are not always known, which may
cause additional unforeseen requirements placed on us as their
contract manufacturer and delays in advancing to the next stage of
product development. We also provide novel compounds for cell and
gene therapy applications, which result in additional challenges
for our customers attempting to obtain regulatory approval given
that this field is relatively new, and regulations are evolving.
Customer clinical trials rely on approval from institutional review
boards (“IRBs”) and patient and volunteer enrollment, which makes
timelines unpredictable for advancing to the next stage in product
development. Preclinical studies and clinical trials conducted by
our customers are also expensive and data may be negative or
inconclusive causing customers to abandon projects that were
expected to continue. Regulatory requirements in both the United
States and abroad are always evolving and compliance with future
laws may require significant investment to ensure
compliance.
Other Regulatory Requirements
Environmental laws and regulations.
We believe that our operations comply in all material respects with
applicable laws and regulations concerning environmental
protection. To date, there have been no material effects upon
our earnings or competitive position resulting from our compliance
with applicable laws or regulations enacted or adopted relating to
the protection of the environment. Our capital and operating
expenditures for pollution control in 2022 and 2021 were not
material.
Intellectual Property
Our success depends in part on our ability to obtain and maintain
intellectual property protection for our products and services,
defend and enforce our intellectual property rights, preserve the
confidentiality of our trade secrets, and operate without
infringing, misappropriating or otherwise violating valid and
enforceable intellectual property rights of others. We seek to
protect the investments made into the development of our products
and services by relying on a combination of patents, trademarks,
copyrights, trade secrets, including know-how, and license
agreements. We also seek to protect our proprietary products and
services, in part, by requiring our employees, consultants,
contractors and other third parties to execute confidentiality
agreements and invention assignment agreements.
Patents.
Our intellectual property strategy is focused on protecting through
patents and other intellectual property rights our core products
and services, including CleanCap, and related instrumentation and
applications. In addition, we protect our ongoing research and
development into critical reagents for cell and gene therapy
through patents and other intellectual property rights. Our patent
portfolio generally includes patents and patent applications
relating to compositions and methods for the production of
oligonucleotides, nucleic acids, immunofluorescence assays, and
mock viral particles. We may own provisional patent applications,
and provisional patent applications are not eligible to become
issued patents until, among other things, we file national stage
patent applications either directly or via the PCT within 12 or 30
to 32 months, respectively. If we do not timely file any national
stage patent applications, we may lose our priority date with
respect to our provisional patent applications and any patent
protection on the inventions disclosed in such provisional patent
applications. We cannot predict whether any such patent
applications will result in the issuance of patents that provide us
with any competitive advantage.
Issued patents extend for varying periods depending on the date of
filing of the patent application or the date of patent issuance and
the legal term of patents in the countries in which they are
obtained. Generally, utility patents issued for applications are
granted a term of 21 years from the earliest effective filing date
of a non-provisional patent application. Issued patents may be
extended beyond the natural 21 year term for regulatory or
administrative delay in accordance with provisions of applicable
local law. As a result, our patent portfolio may not provide us
with sufficient rights to exclude others from commercializing
products similar or identical to ours.
The following granted patents relate to our CleanCap products and
technology.
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Patent Number |
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Title |
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Expiration |
United States |
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10494399
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Compositions and methods for synthesizing 5′-Capped
RNAs
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2036 |
United States |
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10519189
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Compositions and methods for synthesizing 5′-Capped
RNAs
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2036 |
United States |
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10913768C1
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Compositions and methods for synthesizing 5′-Capped
RNAs
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2036 |
United States |
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11414453
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Compositions and methods for synthesizing 5′-Capped
RNAs
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2036 |
Europe |
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3352584
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Compositions and methods for synthesizing 5′-Capped
RNAs
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2036 |
Australia |
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2016328645
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Compositions and methods for synthesizing 5′-Capped
RNAs
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2036 |
Japan |
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6814997
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Compositions and methods for synthesizing 5′-Capped
RNAs
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2036 |
Japan |
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7082174
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Compositions and methods for synthesizing 5′-Capped
RNAs
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2036 |
The following patents relate to our MockV related products and
technology.
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Expiration |
United States |
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9632087
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Methods for evaluating viral clearance from a biopharmaceutical
solution employing mock viral particles
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2034 |
United States |
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10309963
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Methods for evaluating viral clearance from a process solution
employing mock viral particles
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2034 |
Europe |
|
3044339
|
|
Methods and kits for quantifying the removal of mock virus
particles from a purified solution
|
|
2034 |
Australia |
|
2014320015 |
|
Methods and kits for quantifying the removal of Mock Virus
Particles from a purified solution
|
|
2034 |
China |
|
105899684
|
|
Methods and kits for quantifying pseudoviral particles removed from
purified solution
|
|
2034 |
Japan |
|
6549126
|
|
Methods and kits for removal of mock virus particles from a
purified solution
|
|
2034 |
Trademarks.
Our trademark portfolio is designed to protect the brands of our
current and future products and includes U.S. trademark
registrations for our company name, Maravai LifeSciences,
subsidiary names Cygnus Technologies and TriLink Biotechnologies
and various product names, such as CleanCap and MockV.
Trade Secrets.
We also rely on trade secrets, including know-how, unpatented
technology and other proprietary information, to strengthen our
competitive position. We have determined that certain technologies,
such as the production of antibodies for biologics safety testing,
are better kept as trade secrets, rather than pursuing patent
protection. To prevent disclosure of trade secrets to others, it is
our policy to enter into nondisclosure, invention assignment and
confidentiality agreements with parties who have access to trade
secrets, such as our employees, collaborators, outside scientific
collaborators, consultants, advisors and other third parties. These
agreements also provide that all inventions resulting from work
performed for us or relating to our business and conceived or
completed during the period of employment or assignment, as
applicable, are our exclusive property. In addition, we take other
appropriate precautions, such as physical and technological
security measures, to guard against misappropriation of our
proprietary information by third parties.
We intend to pursue additional intellectual property protection to
the extent we believe it would advance our business objectives.
Notwithstanding these efforts, there can be no assurance that we
will adequately protect our intellectual property or provide any
competitive advantage. We cannot provide any assurance that any
patents will be issued from our pending or any future patent
applications or that any issued patents will adequately protect our
products or technology. Our intellectual property rights may be
invalidated, held unenforceable, circumvented, narrowed or
challenged. In addition, the laws of various foreign countries
where our products are distributed may not protect our intellectual
property rights to the same extent as laws in the United States.
Furthermore, it may be difficult to protect our trade secrets.
While we have confidence in the measures we take to protect and
preserve our trade secrets, they may be inadequate and can be
breached, and we may not have adequate
remedies for violations of such measures. In addition, our trade
secrets may otherwise become known or be independently discovered
by competitors. Moreover, our invention assignment agreements with
employees, collaborators, outside scientific collaborators,
consultants, advisors and other third parties may not be
self-executing or otherwise provide meaningful protection for our
intellectual property rights. If we do not adequately protect our
intellectual property, third parties, including our competitors,
may be able to use our technologies to produce and market products
that compete with us and erode our competitive advantage. For more
information regarding risks related to intellectual property,
please see Item 1A. “Risk Factors—Risks Related to our Intellectual
Property.”
Human Capital Management
Operating a sustainable business begins with our people. As of
December 31, 2022, we had over 610 full-time employees. Among
our employees, 46% identified as female, 54% identified as male and
55% identified as ethnically or racially diverse. Approximately 18%
of our employees have earned advanced degrees and all employees
receive rigorous on the job training. None of our employees is
represented by a labor union, and none of our employees has entered
into a collective bargaining agreement with us. We offer a highly
competitive compensation and benefits program to attract and retain
top talent. We believe it is important for our employees to have an
ownership stake in our company, so all eligible employees receive
equity awards under our 2020 Omnibus Incentive Plan and have the
opportunity to purchase stock at a discount under our 2020 Employee
Stock Purchase Plan.
At Maravai, our success hinges on our ability to attract, engage,
develop and retain a talented and diverse team who share our core
values and mission to enable the miracles of science. Our talented
employees drive our mission and help shape our culture, which plays
an invaluable role in our execution at all levels in our
organization. Our culture reflects our shared core values which we
believe contribute to our success and the continued growth of our
organization. We use our core values in candidate screening
and performance management to help reinforce their importance in
our organization.
Our mission and core values are coded into our culture and help
guide our path forward. We define our company culture and guiding
principles with a simple acronym for how we conduct ourselves and
service our clients: CODE.
•Connected
— believing in people, trust and collaboration.
•Open
— embracing ideas and perspectives for better
outcomes.
•Driven
— finding a better way, always.
•Empowered
- valuing integrity and accountability in everything we
do.
Our human capital management strategy oversees culture, talent
acquisition, compensation and benefits, employee engagement,
training and development, health and wellness and diversity, equity
and inclusion. In 2022, we made strategic advancements in each of
these areas to help ensure our workforce is aligned with our
mission and values. For example, we implemented a new global
applicant tracking system that enables us to better organize, track
and engage with candidates throughout the recruitment and hiring
process. We also launched a comprehensive, five-day orientation
program for new employees called “Foundations,” which includes
informational sessions with leadership and more than twenty hours
of self-directed training.
As part of our efforts to enhance our company culture, we have
dedicated personnel focused on our diversity, equity and inclusion
strategy and launched our first employee resource group, Women in
Leadership, and proud to have an executive leadership team that is
50% women. To improve the quality of our colleagues’ experience at
Maravai, we measured various levels of engagement through a
company-wide survey and received an average participation rate of
91%. We use the results from our survey to develop action plans
that we can incorporate into our human capital management
strategy.
As a leading life sciences company. we are committed to the health,
safety and well-being of our employees. All employees exposed to
potential hazards are required to complete annual health and safety
training, including laboratory chemical safety, hazard
communication and hazardous waste management. In 2022, we continued
to strengthen our comprehensive environmental, health and safety
management system, which includes an online incident reporting
platform across all company sites. Additionally, we have
implemented incident intervention services which include
telemedicine for some of our locations. Through our employee
assistance program, employees and their families are offered up to
three sessions with licensed counseling professionals at no cost to
the employee and have on-demand access to additional online
resources.
Available Information
Our website is located at www.maravai.com, and our investor
relations website is located at investors.maravai.com. Our Annual
Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K, and our Proxy Statements, and any
amendments to these reports, are available through our investor
relations website, free of charge, after we file them with the SEC.
Our filings with the SEC are also available, free of charge, on the
SEC's website at www.sec.gov. We webcast via our investor relations
website our earnings calls and certain events we participate in or
host with members of the investment community. Our investor
relations website also provides notifications of news or
announcements regarding our financial performance and other items
that may be material or of interest to our investors, including SEC
filings, investor events, press and earnings releases, and blogs.
The contents of our website are not incorporated by reference into
this Annual Report on Form 10-K or in any other report or document
we file with the SEC, and any references to our website are
intended to be inactive textual references only.
Item 1A. Risk Factors
In addition to the other information in this report and our other
filings with the SEC, you should carefully consider the risks and
uncertainties described below, which could materially and adversely
affect our business operations, financial condition and results of
operations. The risks and uncertainties described below are not the
only ones we face. Additional risks and uncertainties that we are
unaware of, or that we currently believe are not material, may also
become important factors that affect us. You should carefully
consider the risks described below, together with the financial and
other information contained in this Annual Report on Form 10-K. If
any of the following risks occur, our business, financial
condition, results of operations and prospects could be materially
and adversely affected. In that event, the price of our Class A
common stock could decline, and you could lose all or part of your
investment.
Summary of Risk Factors
The following is a summary of the risk factors our business faces.
The list below is not exhaustive, and investors should read this
“Risk Factors” section in full.
•The
extent and duration of our revenue associated with COVID-19-related
products and services are uncertain and are dependent, in important
respects, on factors outside our control.
•Changes
in economic conditions could negatively impact our revenue and
earnings.
•Certain
of our products are used by customers in the production of vaccines
and therapies, some of which represent relatively new and
still-developing modes of treatment. Unforeseen adverse events,
negative clinical outcomes, development of alternative therapies,
or increased regulatory scrutiny of these and their financial cost
may damage public perception of the safety, utility, or efficacy of
these vaccines and therapies or other modes of treatment and may
harm our customers’ ability to conduct their business. Such events
may negatively impact our revenue and have an adverse effect on our
performance.
•We
are dependent on our customers’ spending on and demand for
outsourced nucleic acid production and biologics safety testing
products and services. A reduction in spending or demand could have
a material adverse effect on our business, financial condition,
results of operations, cash flows and prospects.
•We
compete with life science, pharmaceutical and biotechnology
companies who are substantially larger than we are and potentially
capable of developing new approaches that could make our products,
services and technology obsolete.
•If
our products and services do not perform as expected or the
reliability of the technology on which our products and services
are based in questioned, we could experience lost revenue, delayed
or reduced market acceptance of our products and services,
increased costs and damage to our reputation.
•Our
products are highly complex and are subject to quality control
requirements.
•Our
commercial success depends on the market acceptance of our life
science reagents. Our reagents may not achieve or maintain
significant commercial market acceptance.
•Our
operating results may fluctuate significantly in the future, which
makes our future operating results difficult to predict and could
cause our operating results to fall below expectations or any
guidance we may provide.
•Ongoing
geopolitical instability and the resulting economic disruption may
negatively impact our business, operations and financial
condition.
•Product
liability lawsuits against us could cause us to incur substantial
liabilities, limit sales of our existing products and limit
commercialization of any products that we may develop.
•Our
acquisitions expose us to risks that could adversely affect our
business, and we may not achieve the anticipated benefits of
acquisitions of businesses or technologies.
•We
depend on a limited number of customers for a high percentage of
our revenue. If we cannot maintain our current relationships with
customers, fail to sustain recurring sources of revenue with our
existing customers, or if we fail to enter into new relationships,
our future operating results will be adversely
affected.
•We
rely on a limited number of suppliers or, in some cases, sole
suppliers, for some of our raw materials and may not be able to
find replacements or immediately transition to alternative
suppliers.
•Our
products could become subject to more onerous regulation by the FDA
or other regulatory agencies in the future, which could increase
our costs and delay or prevent commercialization of our products,
thereby materially and adversely affecting our business, financial
condition, results of operations, cash flows and
prospects.
•If
we are unable to obtain, maintain and enforce intellectual property
protection for our current or future products, or if the scope of
our intellectual property protection is not sufficiently broad, our
ability to commercialize our products successfully and to compete
effectively may be materially adversely affected.
•If
we fail to comply with our obligations under any license
agreements, disagree over contract interpretation, or otherwise
experience disruptions to our business relationships with our
licensors, we could lose intellectual property rights that are
necessary to our business.
•Our
existing indebtedness could adversely affect our business and
growth prospects.
•Our
principal asset is our interest in Maravai Topco Holdings, LLC
(“Topco LLC”), and, accordingly, we depend on distributions from
Topco LLC to pay our taxes and expenses, including payments under
the Tax Receivable Agreement. Topco LLC’s ability to make such
distributions may be subject to various limitations and
restrictions.
•Conflicts
of interest could arise between our shareholders and Maravai Life
Sciences Holdings, LLC (“MLSH 1”), which may impede business
decisions that could benefit our shareholders.
•The
Tax Receivable Agreement requires us to make cash payments to MLSH
1 and Maravai Life Sciences Holdings 2, LLC (“MLSH 2”) in respect
of certain tax benefits to which we may become entitled, and we
expect that the payments we will be required to make will be
substantial.
•Our
organizational structure, including the Tax Receivable Agreement,
confers certain benefits upon MLSH 1 and MLSH 2 that will not
benefit the other common shareholders to the same extent as they
will benefit MLSH 1 and MLSH 2.
•GTCR,
LLC (“GTCR”) controls us, and its interests may conflict with ours
or yours in the future.
•Provisions
of our corporate governance documents could make an acquisition of
us more difficult and may prevent attempts by our shareholders to
replace or remove our current management, even if beneficial to our
shareholders.
Risks Related to Our Business and Strategy
The extent and duration of our revenue associated with COVID-19
related products and services are uncertain and are dependent, in
important respects, on factors outside our control.
Certain of our products, including our proprietary CleanCap®
analogs, are used by our customers in the production of COVID-19
vaccines.
While our
results
of operations and cash flows have been positively impacted by a
strong demand for our proprietary CleanCap analogs and ongoing
demand for highly modified RNA products, particularly mRNA,
the evolving nature of the COVID-19 pandemic and the resulting
global public health response will affect the continued demand for
our COVID-19 related products and services, which have comprised
the majority of our revenue for the past three years. For the years
ended December 31, 2022, 2021 and 2020, we estimate that
revenue from COVID-19 related products and services represented
approximately 67.9%, 69.7% and 35.4%, respectively, of our total
revenues. The ongoing manufacture and supply of COVID-19 vaccines
(including bivalent booster doses) by our customers is uncertain
and subject to various political, social, economic, and regulatory
factors that are outside of our control, including the duration of
the pandemic; emerging information concerning the severity and
incidence of the virus and its variants; the emergence of
additional virus variants; regional resurgences of the virus
globally; the rate at which the population globally becomes
vaccinated against COVID-19; the development and availability of
antiviral therapeutic alternatives; the lapsing of the public
health emergency declaration made pursuant to Section 319 of the
Public Health Service Act in January 2020 with respect to the
COVID-19 pandemic; and political and social debate relating to the
need for, efficacy of, or side effects related to one or more
specific COVID-19 vaccines. As the supply and manufacture of
COVID-19 vaccines by our customers slows, or becomes no longer
necessary, including if COVID-19 vaccines by our customers’
competitors are determined or perceived to be more effective, we
expect that demand for our COVID-19 related products and services
will significantly decrease, which would have a material adverse
effect on our revenue, results of operations and financial
condition.
Changes in economic conditions could negatively impact our revenue
and earnings.
Our reagents are sold primarily to biopharmaceutical and academic
organizations developing novel vaccines and therapies and
performing basic research. Research and development spending by our
customers and the availability of government research funding can
fluctuate due to changes in available resources, mergers of
pharmaceutical and biotechnology companies, spending priorities,
general economic conditions and institutional and governmental
budgetary policies. Our biologics safety testing customers are
biopharmaceutical companies, contract research organizations
(“CROs”), contract development and manufacturing organizations
(“CDMOs”) and life science companies, which largely serve the
biopharmaceutical industry. Our nucleic acid production customers
are largely vaccine and therapeutic drug makers or diagnostics
manufacturers, which rely in
part on government healthcare-related policies and funding. As a
result, changes in government funding for certain research,
decreases in or the imposition of limits on government spending
more generally (including as a result of the U.S. federal debt
ceiling), or reductions in overall healthcare spending could
negatively impact us or our customers and, correspondingly, our
sales to them. In particular, if the U.S. Congress fails to
increase the U.S. federal debt ceiling, reimbursements we are
eligible to receive under the Cooperative Agreement we entered into
with the U.S. Department of Defense may be jeopardized, which would
negatively affect our business, operations and financial
condition
Currently, the U.S. and global economies are experiencing ongoing
macroeconomic challenges, including labor shortages, supply chain
disruptions and historic rates of inflation, which have led to
increasing interest rates, volatility in the capital and credit
markets, and fiscal and monetary policy uncertainty. Our business
operations, as well as our customers’ and suppliers’ business
operations, have been impacted, and are expected to continue to be
impacted, by these negative conditions. In particular, labor
shortages and wage inflation have affected our ability to hire,
develop and retain our talented and diverse workforce, to maintain
performance levels (especially cost and schedule), and to maintain
our corporate culture. Further, if our raw material and other
laboratory material suppliers experience operational challenges as
a result of labor shortages, limited material availability,
logistics delays and transportation capacity constraints, or are
unable to access adequate capital to support their working capital
requirements, they may be unable to provide raw materials or other
laboratory materials to us in a timely manner or at a reasonable
cost, which could adversely affect our profit margins and results
of operations.
Additionally, demand for our products and services could be
adversely impacted if these ongoing macroeconomic challenges cause
customers to reduce their operating budgets, adversely impact our
customers’ ability to commit funds to purchase our products, or
otherwise cause customers to delay, cancel, decrease or forego
purchases of our products and services. Further, since the majority
of our customers’ contracts can be terminated, delayed or reduced
in scope upon short notice or no notice, this may require us to
carry excess inventory to manage through unevenness in order
activity and lead to unanticipated fluctuations in our quarterly
revenue and earnings. If we are not able to forecast and adequately
manage through changes in our customers’ order requirements, our
productivity, profitability, results of operations, cash flows and
financial position could be negatively impacted. Further
deterioration or a protracted extension of these negative
macroeconomic conditions, a potential economic downturn or
recession, or a significant reduction or delay in governmental
funding as a result of U.S. federal budget issues, or the
perception that any of these events may occur, could cause a
decline in demand for our products and services and adversely
affect our performance and result in declines in our revenue and
earnings.
Certain of our products are used by customers in the production of
vaccines and therapies, some of which represent relatively new and
still-developing modes of treatment. Unforeseen adverse events,
negative clinical outcomes, or increased regulatory scrutiny of
these and their financial cost may damage public perception of the
safety, utility, or efficacy of these vaccines and therapies or
other modes of treatment and may harm our customers’ ability to
conduct their business. Such events may negatively impact our
revenue and have an adverse effect on our performance.
Gene therapy and nucleic acid vaccines remain relatively new and
are under active development, with only a few gene therapies and
nucleic acid vaccines, including those for COVID-19, approved to
date by regulatory authorities. Public perception may be influenced
by claims that gene therapy or nucleic acid vaccines are unsafe or
ineffective, and gene therapy may not gain the acceptance of the
public or the medical community. Following the release of nucleic
acid COVID-19 vaccines, including those that incorporate our
CleanCap® products, segments of the population have criticized
their safety and efficacy impacting vaccine demand. In addition,
ethical, social, legal and financial concerns about gene therapy
and nucleic acid vaccines, including COVID-19 vaccines, could
result in additional regulations or limitations or even
prohibitions on certain gene therapies or vaccine-related products.
Our customers’ use of our products and services in therapeutic and
vaccine development programs for other (non-COVID-19-related)
indications could be impacted by more restrictive regulations or
negative public perception, which could negatively affect our
business prospects, revenue and results of operation.
We are dependent on our customers’ spending on and demand for
outsourced nucleic acid production and biologics safety testing
products and services. A reduction in spending or demand could have
a material adverse effect on our business, financial condition,
results of operations, cash flows and prospects.
The success of our business depends primarily on the number and
size of contracts with our customers, primarily pharmaceutical and
biotechnology companies, for our products and services. As
discussed above, during the COVID-19 pandemic we benefited from a
significant increase in demand for our products and service,
including our proprietary CleanCap® analogs that are used by our
customers in the production of COVID-19 vaccines, and more
generally, as a result of the continued growth of the global
biologics market, increasing research and development budgets of
our customers and a greater degree of outsourcing by our customers.
A slowing or reversal of any of these trends, including a decrease
in the amount of COVID-19 vaccines manufactured or supplied by our
customers, could have a significant adverse effect on the demand
for our products and services.
In addition to these industry trends, our customers’ willingness
and ability to utilize our products and services are also subject
to, among other things, their own financial performance, changes in
their available resources, their decisions to acquire in-house
manufacturing capacity, their spending priorities, their budgetary
policies and practices and their need to develop new biological
products, which, in turn, are dependent upon a number of factors,
including their competitors’ discoveries, developments and
commercial manufacturing initiatives and the anticipated market,
clinical and reimbursement scenarios for specific products and
therapeutic areas. In addition, consolidation in the industries in
which our customers operate may have an impact on our customers’
spending as they integrate acquired operations, including research
and development departments and associated budgets. If our
customers reduce their spending on our products and services as a
result of any of these or other factors, our business, financial
condition, results of operations, cash flows and prospects would be
materially and adversely affected.
We compete with life science, pharmaceutical and biotechnology
companies who are substantially larger than we are and potentially
capable of developing new approaches that could make our products,
services and technology obsolete.
The market for pharmaceutical, reagent, therapeutic and diagnostic
products and services is intensely competitive, rapidly evolving,
significantly affected by new product introductions and other
market activities by industry participants and subject to rapid
technological change. We also expect increased competition as
additional companies enter our market and as more advanced
technologies become available. We compete with other providers of
outsourced biologics products and services. We also compete with
the in-house discovery, development and commercial manufacturing
functions of pharmaceutical and biotechnology companies. Many of
our competitors are large, well-capitalized companies with
significantly greater resources and market share than we have. As a
consequence, these competitors are able to spend more aggressively
on product and service development, marketing, sales and other
initiatives than we can. Many of these competitors also
have:
•broader
name recognition;
•longer
operating histories and the benefits derived from greater economies
of scale;
•larger
and more established distribution networks;
•additional
product and service lines and the ability to bundle products and
services to offer higher discounts or other incentives to gain a
competitive advantage;
•more
experience in conducting research and development, manufacturing
and marketing;
•more
experience in entering into collaborations or other strategic
partnership arrangements; and
•more
financial, manufacturing and human resources to support product
development, sales and marketing and patent and other intellectual
property litigation.
These factors, among others, may enable our competitors to market
their products and services at lower prices or on terms more
advantageous to customers than we can offer. Competition may result
in price reductions, reduced gross margins and loss of market
share, any of which could have a material adverse effect on our
business, financial condition, results of operations, cash flows
and prospects. Additionally, our current and future competitors,
including certain of our customers, may at any time develop
additional products and services that compete with our products and
services and new approaches by these competitors may make our
products, services, technologies and methodologies obsolete or
noncompetitive. We may not be able to compete effectively against
these organizations.
In addition, to develop and market our new products, services,
technologies and methodologies successfully, we must accurately
assess and meet customers’ needs, make significant capital
expenditures, optimize our development and manufacturing processes
to predict and control costs, hire, train and retain the necessary
personnel, increase customer awareness and acceptance of our
services, provide high-quality services in a timely manner, price
our products and services competitively and effectively integrate
customer feedback into our business planning. If we fail to create
demand for our new products, services or technologies, our future
business could be harmed.
If our products and services do not perform as expected or the
reliability of the technology on which our products and services
are based is questioned, we could experience lost revenue, delayed
or reduced market acceptance of our products and services,
increased costs and damage to our reputation.
Our success depends on the market’s confidence that we can provide
reliable, high-quality life science reagents. We believe that
customers in our target markets are likely to be particularly
sensitive to product defects and errors. Our reputation and the
public image of our products, services and technologies may be
impaired if our products or services fail to perform as
expected.
Although our products are tested prior to shipment, defects or
errors could nonetheless occur. Our operating results depend on our
ability to execute and, when necessary, improve our quality
management strategy and systems and our ability to
effectively
train and maintain our employee base with respect to quality
management. A failure of our quality control systems could result
in problems with facility operations or preparation or provision of
products. In each case, such problems could arise for a variety of
reasons, including equipment malfunction, failure to follow
specific protocols and procedures, problems with raw materials or
environmental factors and damage to, or loss of, manufacturing
operations. Such problems could affect production of a particular
batch or series of batches of products, requiring the destruction
of such products or a halt of facility production altogether.
Furthermore, some of the products that we manufacture are
subsequently incorporated into products that are sold by other life
sciences companies and we have no control over the manufacture and
production of those products.
In addition, in the event we, or our suppliers, fail to meet
required quality standards and if our products experience, or are
perceived to experience, a material defect or error, our products
could be recalled or we may be unable to timely deliver products to
our customers, which in turn could damage our reputation for
quality and service. In the past, certain of our custom mRNA and
CleanCap reagent products have been sold with insufficient capping
efficiency or with incorrect transcription instructions.
Additionally, several lots of our host cell protein (“HCP”)
enzyme-linked immunosorbent assay (“ELISA”) biologics safety
testing kits have experienced a possible instability drift and
decrease in accuracy. Although we have taken steps to improve our
quality review, product documentation and reference testing
procedures, we cannot guarantee that we will not experience quality
assurance issues with our products in the future. Any such failure
could, among other things, lead to increased costs, delayed or lost
revenue, delayed market acceptance, damaged reputation, diversion
of development resources, legal claims, reimbursement to customers
for lost drug product, starting materials and active pharmaceutical
ingredients, other customer claims, damage to and possibly
termination of existing customer relationships, increased insurance
costs, time and expense spent investigating the cause and,
depending on the cause, similar losses with respect to other
batches or products, any of which could harm our business,
financial condition, results of operations, cash flows and
prospects. Such defects or errors could also narrow the scope of
the use of our products, which could hinder our success in the
market.
Even after any underlying concerns or problems are resolved, any
lingering concerns in our target markets regarding our technology
or any manufacturing defects or performance errors in our products
or services could continue to result in lost revenue, delayed
market acceptance, damage to our reputation and claims against
us.
In addition, we may be unable to maintain the quality, reliability,
robustness and expected turnaround times of our products and
services to continue to satisfy customer demand as we grow. To
effectively manage our growth, we must continue to improve our
operational, manufacturing and quality control systems and
processes and other aspects of our business and continue to
effectively expand, train and manage our personnel. The time and
resources required to improve our existing systems and procedures,
implement new systems and procedures and to adequately staff such
existing and new systems and procedures is uncertain, and failure
to complete this in a timely and efficient manner could adversely
affect our operations and negatively impact our business and
financial results. We may need to purchase additional equipment,
some of which can take several months or more to procure, set up
and validate, establish new production processes and increase our
personnel levels to meet increased demand. There can be no
assurance that any of these increases in scale, personnel expansion
or equipment or process enhancements will be successfully
implemented, or that we will have adequate space, including in our
laboratory and production facilities, to accommodate such required
expansion. Failure to manage this growth or transition could result
in delays in turnaround times, higher product costs, declining
product quality, deteriorating customer service and slower
responses to competitive challenges. A failure in any one of these
areas could make it difficult for us to meet market expectations
for our products and services and could damage our reputation and
our business, financial condition, results of operations, cash
flows and prospects could be adversely affected.
Our products are highly complex and are subject to quality control
requirements.
Whether a product is produced by us or purchased from outside
suppliers, it is subject to quality control procedures, including
the verification of stability and performance and, for certain
products, additional validation required by certain GMP that we
voluntarily follow, European Conformity (“CE”) marking and ISO
9001:2015 compliance, prior to final packaging. Certain of our
products are manufactured following the voluntary GMP quality
standards of the International Council for Harmonisation’s GMP
Guide, comparable GMP principles for the European Union and
customer-specific requirements. We believe these products are
exempt from compliance with the Food, Drug, and Cosmetic Act
(“FDCA”) and the current GMP (“cGMP”) regulations of the Food and
Drug Administration (“FDA”), as our products are further processed
and incorporated into final drug products by our customers and we
do not make claims related to their safety or effectiveness. In the
event we, or our suppliers, produce products that fail to comply
with required quality standards, we may incur delays in fulfilling
orders, write-downs, damages resulting from product liability
claims and harm to our reputation.
Our operating results may fluctuate significantly in the future,
which makes our future operating results difficult to predict and
could cause our operating results to fall below expectations or any
guidance we may provide.
Our quarterly and annual operating results may fluctuate
significantly, which makes it difficult for us to predict our
future operating results. These fluctuations may be driven by a
variety of factors, many of which are outside of our control,
including, but not limited to:
•demand
from our largest customers for COVID-19-related products and
services (which currently comprise a significant percentage of our
revenue and orders) may not meet our expectations regarding volume
and price in any given time period;
•the
level of demand for our other (non-COVID-19-relate) products and
services, which may vary significantly;
•our
ability to increase penetration in our existing markets and expand
into new markets;
•our
customers accelerating, canceling, reducing or delaying orders as a
result of developments related to their pre-clinical studies and
clinical trials;
•the
relative reliability and robustness of our products and
services;
•changes
in governmental regulations or the regulatory posture toward our
business;
•the
volume and mix of the products and services we sell;
•changes
in the production or sales costs related to our products and
services;
•the
ongoing success of our newer products, such as our CleanCap® and
mRNA products;
•
the rate of introduction of other new products or product
enhancements by us or others in our industry;
•the
timing and amount of expenditures that we may incur to acquire,
develop or commercialize additional products, services and
technologies or for other purposes, such as the expansion of our
facilities;
•changes
in governmental and academic funding of life sciences research and
developments or changes that impact budgets, budget cycles or
seasonal spending patterns of our customers;
•future
accounting pronouncements or changes in our accounting
policies;
•difficulties
encountered by our commercial carriers in delivering our products,
whether as a result of external factors such as weather or negative
macroeconomic conditions or internal issues such as labor
disputes;
•general
market conditions and other factors outside of our control, such as
natural disasters, geopolitical unrest, war, terrorism, public
health issues (including the ongoing COVID-19 pandemic) or other
catastrophic events; and
•the
other factors described in this “Risk Factors”
section.
The impact of any one of the factors discussed above, or the
cumulative effects of a combination of such factors, could result
in significant fluctuations and unpredictability in our quarterly
and annual operating results. As a result, comparisons of our
operating results on a period-to-period basis may not be
meaningful. Investors should not rely on our past results as an
indication of our future performance.
As a result of variability and unpredictability, we may also fail
to meet the expectations of industry or financial analysts or
investors for any period. If our revenue or operating results fall
short of the expectations of analysts or investors or any guidance
we may provide, or if the guidance we provide falls short of the
expectations of analysts or investors, the price of our Class A
common stock could decline substantially. Such a stock price
decline could occur even when we have met or exceeded any
previously publicly stated guidance we may have
provided.
If we are unable to manufacture in specific quantities, our
operating results will be harmed.
Our revenue and other operating results depend in large part on our
ability to manufacture and ship our products in sufficient
quantities. Any interruptions we experience in the manufacturing or
shipping of our products could delay our ability to recognize
revenue in a particular quarter. Manufacturing problems can and do
arise, and as demand for our products increases, any such problems
could have an increasingly significant impact on our operating
results. While we have not generally experienced problems with, or
delays in, our production capabilities that resulted in delays in
our ability to ship finished products, there can be no assurance
that we will not encounter such problems in the future. We may not
be able to quickly ship products and recognize anticipated revenue
for a given period if we experience significant delays in the
manufacturing process. In addition, we must maintain sufficient
production capacity in order to meet anticipated customer demand,
and we may be unable to offset the associated fixed costs if orders
slow, which would adversely affect our operating margins. If we are
unable
to manufacture and ship our products consistently, in sufficient
quantities and on a timely basis, our revenue, cash flow, gross
margins and our other results of operations will be materially and
adversely affected.
A pandemic, epidemic, or outbreak of an infectious disease, such as
COVID-19, has affected, and may continue to affect our business,
financial condition, results of operations, cash flows and
prospects.
The COVID-19 pandemic led to the implementation of various
responses, including government imposed shelter-in-place orders,
quarantines, travel restrictions and other public health safety
measures, as well as reported adverse impacts on healthcare
resources, facilities and providers across the United States and in
other countries. In response to the spread of COVID-19, we
restricted access to our facilities mostly to personnel and third
parties required to perform critical activities that must be
completed on-site, limited the number of such personnel that can be
present at our facilities at any one time, and requested that many
of our personnel work remotely. In the event that government
authorities are willing to reimplement restrictions in response to
a new variant of concern or increased infection rates, our
employees conducting research and development or manufacturing
activities may not be able to access our laboratory or
manufacturing facilities and our core activities may be
significantly limited or curtailed, possibly for an extended period
of time.
As a result of the COVID-19 pandemic, or similar pandemics and
outbreaks that may occur in the future, we have experienced and may
in the future experience severe disruptions,
including:
•interruption
of or delays in receiving products and supplies from the third
parties we rely on to, among other things, manufacture components
to our products, due to staffing shortages, production slowdowns or
stoppages and disruptions in delivery systems, which may impair our
ability to manufacture and sell our products and
services;
•limitations
on our business operations by the local, state or federal
government that could impact our ability to manufacture, sell or
deliver our products and services;
•on-site
visit limitations and prohibitions imposed by customers that could
impact our ability to engage in pre-sales activities, and to
provide post-sale activities, such as training, service and
support;
•delays
in customers’ purchasing decisions and negotiations with customers
and potential customers;
•business
disruptions caused by workplace, laboratory and office closures and
an increased reliance on employees working from home, travel
limitations, cyber security and data accessibility limits, or
communication or mass transit disruptions;
•limitations
on employee resources that would otherwise be focused on the
conduct of our activities, including because of sickness of
employees or their families or the desire of employees to avoid
contact with large groups of people;
•reductions
in productivity of our customers in certain countries or regions
due to government-mandated shutdowns and quarantines, such as
China’s Zero Covid Policy; and
•increased
competition as quarantines and shelter-in-place orders are lifted
by governments in regions where our competitors, particularly
international competitors, are located.
Any of these factors could severely impact our research and
development activities, manufacturing business operations and sales
or delay necessary interactions with local regulators, third-party
vendors and other important contractors and customers.
The extent to which the current or any future pandemic may
negatively impact our consolidated operations and results of
operations or those of our third-party manufacturers, suppliers,
partners or customers continues depend on future
developments.
The factors that could cause such adverse impact include: the
severity and duration of the pandemic; the emergence of new virus
variants; lack of demand for vaccines; the U.S. economy and global
economy, including impacts resulting from supply chain constraints
and inflationary pressures; and the timing, scope and effectiveness
of U.S. and international governmental, regulatory, fiscal,
monetary and public health responses to such pandemic and
associated economic disruptions.
Ongoing geopolitical instability has resulted in economic
disruption and uncertainty, which may negatively impact our
business, operations, and financial condition.
Russia’s military invasion of Ukraine in late February 2022 further
exacerbated ongoing inflationary pressures, supply chain issues,
and volatility in credit and capital markets, and caused other
market disruptions. Additionally, the United States, the European
Union and other countries have levied sanctions against Russia and
certain other countries, regions, and individuals as a result of
Russia’s military actions in Ukraine, and Russian has imposed its
own sanctions and threatened further retaliatory actions. The
aforementioned factors have caused damage and disruption to
international commerce and the global economy, and a protracted
conflict between Russian and Ukraine, any escalation of said
conflict (including the spread of the conflict to
other countries in Europe), or additional geopolitical turmoil
(such as a further degradation of China-Taiwan relations or trade
relations between China and the United States), could worsen
economic and financial markets and international
relations.
Such geopolitical instability could create supply disruptions and
logistics restrictions that increase our costs, have a detrimental
effect on our ability to manufacture, sell and ship our products,
and impede our ability to collect payments and support customers in
certain regions. Furthermore, the global economy and financial and
capital markets could also be further adversely affected, resulting
in instability and lack of liquidity in capital markets, which
could also negatively impact the value of our stock or our ability
to obtain equity or debt funding.
In addition, there are other challenges, difficulties, and risks
with respect to the way we conduct our business and operations,
generally, that we may experience as a result of continued or
increased geopolitical turmoil. For example, the ongoing
Russia-Ukraine military conflict may create an increased risk of
cybersecurity attacks, including by or at the direction of the
Russian government, in response to financial and economic sanctions
and import and/or export controls imposed on Russia by the United
States and others. While at this time, to the best of our
knowledge, we do not believe we have experienced any such
cyberattacks, we may not be able to address any such cybersecurity
threats proactively or implement adequate preventative measures,
and prompt detection and remediation of any such disruption or
security breach may be difficult, if not impossible.
The foregoing factors could negatively affect our business,
operations and financial condition, though we are unable to predict
the extent or nature of any such impacts at this time. Any such
disruptions may also increase the impact of other risks described
herein, both with respect to their severity and
frequency.
Natural disasters, geopolitical unrest, war, terrorism, public
health issues or other catastrophic events could disrupt the
supply, delivery or demand of products and services, as well as our
sites, which could negatively affect our operations and
performance.
We are subject to the risk of disruption by earthquakes,
hurricanes, floods and other natural disasters, fire, power
shortages, geopolitical unrest, war, terrorist attacks and other
hostile acts, public health issues, epidemics or pandemics, such as
the COVID-19 pandemic, and other events beyond our control and the
control of the third parties on which we depend. Any of these
catastrophic events, whether in the United States or abroad, may
have a significant negative impact on the global economy, our
employees, facilities, partners, suppliers, distributors or
customers, and could decrease demand for our products and services,
create delays and inefficiencies in our supply chain and make it
difficult or impossible for us to deliver products and services to
our customers.
We rely upon our internal manufacturing, packaging and distribution
operations to produce many of the products we sell and our
warehouse facilities to store products pending sale. Any
significant disruption of those operations for any reason, such as
labor disputes or social unrest, power interruptions, fire,
hurricanes, a pandemic (including the ongoing COVID-19 pandemic),
earthquakes or other events beyond our control, could adversely
affect our sales and customer relationships and therefore adversely
affect our business and results of operations. We have significant
operations in California, near major earthquake faults, which make
us susceptible to earthquake risk.
In addition, a catastrophic event that results in damage to
specific equipment that would be difficult to replace, the
destruction or disruption of our research and production facilities
or our critical business or information technology systems would
severely affect our ability to conduct normal business operations
and, as a result, our operating results would be adversely
affected.
Strategic transactions or acquisitions may require us to seek
additional financing, which we may not be able to secure on
favorable terms, if at all.
We plan to continue a strategy of growth and development for our
business. To this end, we actively evaluate various strategic
transactions on an ongoing basis, including licensing or acquiring
complementary products, technologies or businesses that would
complement our existing portfolio of products and services. In
order to complete such strategic transactions, we may need to seek
additional financing to fund these investments and acquisitions.
Should we need to do so, we may not be able to secure such
financing, or obtain such financing on favorable terms, for reasons
including rising interest rates and continued volatility and
uncertainty in the U.S. and global capital and credit markets. Our
credit agreement also contains a number of restrictive covenants
that impose significant restrictions on our ability to make
acquisitions or certain other investments, as well as to incur
additional indebtedness to finance such acquisitions or other
investments. In addition, future acquisitions may require the
issuance or sale of additional equity, or equity-linked securities,
which may result in additional dilution to our
shareholders.
If we are unable to continue to hire and retain skilled personnel,
we will have trouble developing and marketing our products and
services.
Our success depends largely upon the continued service of our
management and scientific staff and our ability to attract, retain
and motivate highly skilled technical, scientific, management and
marketing personnel, who deliver high-quality and timely services
to our customers and keep pace with cutting-edge technologies and
developments in biologics. We face significant competition in the
hiring and retention of such personnel from other companies, other
providers of outsourced biologics services, research and academic
institutions, government and other organizations who have superior
funding and resources and who may use these resources to pursue
personnel more aggressively than we are. Additionally, certain
highly skilled personnel that we seek to employ may be subject to
non-competition or other restrictive covenants restricting their
ability to work for us or within certain aspects of our business
for a period of time. Although some jurisdictions (including the
State of California) prohibit non-competition agreements as a
matter of law, and the U.S. Federal Trade Commission has issued a
notice of proposed rulemaking that would prohibit employers in the
U.S. from using non-compete agreements, if we hire certain
employees from competitors or other companies, those former
employers may attempt to assert that these employees and/or we have
breached certain legal obligations, resulting in a diversion of our
time and resources.
We have, from time to time, experienced, and we expect to continue
to experience, difficulty in hiring and retaining employees with
appropriate qualifications. In recent years, recruiting, hiring and
retaining employees with expertise in our industry and in the
geographies where we operate has become increasingly difficult as
the demand for skilled professionals has increased and as a result
of labor shortages believed to have resulted from actions taken
during the onset of the COVID-19 pandemic, but which are expected
to continue beyond the near-term. The loss of key personnel or our
inability to hire and retain skilled personnel could materially
adversely affect the development of our products and services and
our business, financial condition, results of operations, cash
flows and prospects.
Our commercial success depends on the market acceptance of our life
science reagents. Our reagents may not achieve or maintain
significant commercial market acceptance.
Our commercial success is dependent upon our ability to continue to
successfully market and sell our life science reagents. Our ability
to achieve and maintain commercial market acceptance of our
products and services and provide customers access to our life
science reagents will depend on a number of factors,
including:
•our
ability to increase awareness of the capabilities of our technology
and solutions;
•our
customers’ willingness to adopt new products, services and
technologies;
•whether
our products and services reliably provide advantages over legacy
and other alternative technologies and are perceived by customers
to be cost effective;
•our
ability to execute on our strategy to scale-up our CleanCap
technology to meet increasing demand and provide channels to access
our CleanCap technology and life science reagents;
•the
rate of adoption of our products and services by biopharmaceutical
companies, academic institutions and others;
•the
relative reliability and robustness of our products and services as
a whole and the components of our life science offerings,
including, for example, CleanCap and our assays for detecting host
cell proteins;
•our
ability to develop new tools and solutions for
customers;
•whether
competitors develop and commercialize products and services that
provide comparable features and benefits at scale;
•the
impact of our investments in product innovation and commercial
growth;
•negative
publicity regarding our or our competitors’ products resulting from
defects or errors; and
•our
ability to further validate our technology through research and
accompanying publications.
We cannot assure you that we will be successful in addressing these
criteria or other criteria that might affect the market acceptance
of our products and services. If we are unsuccessful in achieving
and maintaining market acceptance of our products and services, our
business, financial condition, results of operations, cash flows
and prospects could be adversely affected.
The market may not be receptive to our new products and services
upon their introduction.
We expect a portion of our future revenue growth to come from
introducing new products, including plasmid DNA and GMP-grade mRNA.
The commercial success of all of our products and services will
depend upon their acceptance by the life science and
biopharmaceutical industries. Some of the products and services
that we are developing are based upon new technologies
or
approaches. As a result, there can be no assurance that these new
products and services, even if successfully developed and
introduced, will be accepted by customers. If customers do not
adopt our new products, services and technologies, our results of
operations may suffer and, as a result, the market price of our
Class A common stock may decline.
It may be difficult for us to implement our strategies for revenue
growth in light of competitive challenges.
We face significant competition across many of our product lines.
In addition, consolidation trends in the pharmaceutical,
biotechnology and diagnostics industries have served to create
fewer customer accounts and to concentrate purchasing decisions for
some customers, resulting in increased pricing pressure on us.
Moreover, customers may believe that larger companies are better
able to compete as sole source vendors, and therefore prefer to
purchase from such businesses. Failure to anticipate and respond to
competitors’ actions may impact our future revenue and
profitability.
Our estimates of market opportunity and forecasts of market growth
may prove to be inaccurate, and even if the market in which we
compete achieves the forecasted growth, our business could fail to
grow at similar rates, if at all.
Addressable market estimates and growth forecasts are subject to
significant uncertainty and are based on assumptions and estimates
that may not prove to be accurate. These estimates and forecasts
are based on a number of complex assumptions and third-party
estimates and other business data, including assumptions and
estimates relating to our ability to generate revenue from existing
products and services and the development of new products and
services. Our estimates and forecasts relating to the size and
expected growth of our markets may prove to be inaccurate. Even if
the markets in which we compete meet our size estimates and growth
forecasts, our business could fail to grow at the rate we
anticipate, if at all.
Product liability lawsuits against us could cause us to incur
substantial liabilities, limit sales of our existing products and
limit commercialization of any products that we may
develop.
Our business exposes us to the risk of product liability claims
that are inherent in the development, production, distribution, and
sale of biotechnology products. We face an inherent risk of product
liability exposure related to the use of certain of our products in
our customers’ human clinical trials and product liability lawsuits
may allege that our products or services identified inaccurate or
incomplete information or otherwise failed to perform as designed.
We may also be subject to liability for errors in, a
misunderstanding of or inappropriate reliance upon, the information
we provide in the ordinary course of our business activities. If
any of our products harm people due to our negligence, willful
misconduct, unlawful activities or material breach, or if we cannot
successfully defend ourselves against claims that our products
caused injuries, we could incur substantial liabilities. Regardless
of merit or eventual outcome, liability claims may result in the
following, any of which could impact our business, financial
condition, results of operations, cash flows and
prospects:
•decreased
demand for our products and any products that we may
develop;
•injury
to our reputation;
•costs
to defend the related litigation;
•loss
of revenue; and
•the
inability to commercialize products that we may
develop.
We maintain product liability insurance, but this insurance is
subject to deductibles, limits and exclusions and may not fully
protect us from the financial impact of defending against product
liability claims or the potential loss of revenue that may result.
Any product liability claim brought against us, with or without
merit, could increase our insurance rates or prevent us from
securing insurance coverage in the future.
We may be unable to efficiently manage growth as a larger and more
geographically diverse organization.
Our strategic acquisitions, the continued expansion of our
commercial sales operations and our organic growth have increased
the scope and complexity of our business. As a result, we will face
challenges inherent in efficiently managing a more complex business
with an increased number of employees over large geographic
distances, including the need to implement appropriate systems,
policies, benefits and compliance programs. Our inability to manage
successfully the geographically more diverse and substantially
larger combined organization could materially adversely affect our
operating results.
Opportunistic acquisitions may pose risks and challenges that could
adversely affect our business, and we may not achieve the
anticipated benefits of acquisitions of businesses or
technologies.
We have made in the past, and may make in the future, selected
opportunistic acquisitions of complementary businesses, products,
services or technologies. In January 2022, we acquired MyChem LLC,
a provider of proprietary, ultra-pure
nucleotides to customers in the diagnostics, pharma, genomics and
research markets to complement our nucleic acid business and in
January 2023, we completed the acquisition of Alphazyme, LLC, an
original equipment manufacturer provider of custom molecular
biology enzymes, servicing customers in the genetic analysis and
nucleic acid synthesis markets to complement our nucleic acid
production business. However, we may be unable to continue to
identify or complete promising acquisitions for many reasons,
including competition among buyers, the high valuations of
businesses in our industry, the need for regulatory and other
approvals and the availability of capital, particularly during a
period of disruption and volatility within the global capital and
credit markets.
Any acquisition involves numerous risks, uncertainties and
operational, financial, and managerial challenges, including the
following, any of which could adversely affect our business,
financial condition, results of operations, cash flows and
prospects:
•difficulties
in integrating new operations, systems, technologies, products,
services and personnel of acquired businesses effectively and in a
timely manner;
•difficulties
in implementing and maintaining controls, procedures and policies
with respect to our financial accounting systems, including
disclosure controls and procedures and internal control over
financial reporting, at acquired businesses that, prior to the
acquisition, had lacked such controls, procedures and
policies;
•lack
of synergies or the inability to realize expected synergies and
cost-savings, including enhanced revenue, technology, human
resources, cost savings, operating efficiencies and other
synergies;
•difficulties
in obtaining and verifying the financial statements and other
business information of acquired businesses;
•difficulties
in managing geographically dispersed operations, including risks
associated with entering new or foreign markets in which we have no
or limited prior experience;
•underperformance
of any acquired technology, product, or business relative to our
expectations and the price we paid;
•negative
near-term impacts on financial results after an acquisition,
including acquisition-related earnings charges;
•the
potential loss of key employees, customers, contractual
relationships, and strategic partners of acquired
companies;
•declining
employee morale and retention issues affecting employees of
businesses that we acquire, which may result from changes in
compensation, or changes in management, reporting relationships,
future prospects or the direction of the acquired
business;
•claims
by terminated employees and shareholders of acquired companies or
other third parties related to the transaction;
•the
assumption or incurrence of historical liabilities, obligations and
expenses of the acquired business, including unforeseen and
contingent or similar liabilities that are difficult to identify or
accurately quantify, or other litigation-related liabilities and
regulatory actions;
•the
assumption or incurrence of additional debt obligations or
expenses, or use of substantial portions of our cash;
•the
issuance of equity or equity-linked securities to finance or as
consideration for any acquisitions that dilute the ownership of our
shareholders;
•the
issuance of equity securities to finance or as consideration for
any acquisitions may not be an option if the price of our Class A
common stock is low or volatile which could preclude us from
completing any such acquisitions;
•the
assumption of certain collaboration, strategic alliance and
licensing arrangement may require us to relinquish valuable rights
to our technologies or products, or grant licenses on terms that
are not favorable to us;
•disruption
of our ongoing operations, diversion of management’s attention and
company resources from existing operations of the business, and the
dedication of significant efforts and expense across all
operational areas, including sales and marketing, research and
development, manufacturing, finance, legal and information
technologies;
•the
impairment of intangible assets as a result of technological
advancements, or worse-than-expected performance of acquired
companies;
•the
need to later divest acquired assets at a loss if an acquisition
does not meet our expectations;
•risks
associated with acquiring intellectual property, including
potential disputes regarding acquired companies’ intellectual
property; and
•difficulties
relating to operating with increased leverage and incurring
additional interest expense as a result of financing acquisitions
with additional indebtedness, which could make us more vulnerable
to downturns.
There can be no assurance we will identify promising acquisition
opportunities. Even if we do, there can be no assurance that any of
the acquisitions we have made, or that we may make, will be
successful or will be, or will remain, profitable. Our failure to
successfully address the foregoing risks may prevent us from
achieving the anticipated benefits from any past or future
acquisition in a reasonable time frame, or at all.
Our ability to use net operating loss and tax credit carryforwards
and certain built-in losses to reduce future tax payments is
limited by provisions of the Internal Revenue Code, and it is
possible that changes in laws or certain transactions or a
combination of certain transactions may result in material
additional limitations on our ability to use our net operating loss
and tax credit carryforwards.
Sections 382 and 383 of the Internal Revenue Code of 1986, as
amended, contain rules that limit the ability of a company that
undergoes an ownership change, which is generally any change in
ownership of more than 50% of its stock over a three-year period,
to utilize its net operating loss and tax credit carryforwards and
certain built-in losses recognized in years after the ownership
change. These rules generally operate by focusing on ownership
changes involving stockholders owning directly or indirectly 5% or
more of the stock of a company and any change in ownership arising
from a new issuance of stock by the company. Generally, if an
ownership change occurs, the yearly taxable income limitation on
the use of net operating loss and tax credit carryforwards and
certain built-in losses is equal to the product of the applicable
long-term, tax-exempt rate and the value of the company’s stock
immediately before the ownership change. As a result, following any
such ownership change, we might be unable to offset our taxable
income with losses, or our tax liability with credits, before such
losses and credits expire, in which event we could incur larger
federal and state income tax liabilities than we would have had we
not experienced an ownership change. In addition, under the 2017
Tax Cuts and Jobs Act (“TCJA”), tax losses generated in taxable
years beginning after December 31, 2017 may be utilized to offset
no more than 80% of taxable income annually. On March 27, 2020, the
Coronavirus Aid Relief, and Economic Security Act (“CARES Act”) was
signed into law and changed certain provisions of the TCJA. Under
the CARES Act, NOLs arising in taxable years beginning after
December 31, 2017 and before January 1, 2021 may be carried back to
each of the five taxable years preceding the tax year of such loss,
but NOLs arising in taxable years beginning after December 31, 2020
may not be carried back. In addition, the CARES Act eliminates the
limitation on the deduction of NOLs to 80% of current year taxable
income for taxable years beginning before January 1, 2021, but the
80% limitation applies to tax years beginning after December 31,
2020. As such, we may not be able to realize a tax benefit from the
use of our NOLs.
We may be required to record a significant charge to earnings if
our goodwill and other amortizable intangible assets, or other
investments become impaired.
We are required under U.S. generally accepted accounting principles
(“GAAP”) to test goodwill for impairment at least annually and to
review our goodwill, amortizable intangible assets and other assets
acquired through merger and acquisition activity for impairment
when events or changes in circumstance indicate the carrying value
may not be recoverable. Factors that could lead to impairment of
goodwill, amortizable intangible assets and other assets acquired
via acquisitions include significant adverse changes in the
business climate and actual or projected operating results
(affecting our company as a whole or affecting any particular
segment) and declines in the financial condition of our business.
We may be required in the future to record additional charges to
earnings if our goodwill, amortizable intangible assets or other
investments become impaired. Any such charge would adversely impact
our consolidated financial results.
Changes in accounting principles and guidance could result in
unfavorable accounting charges or effects.
We prepare our consolidated financial statements in accordance with
GAAP. These principles are subject to interpretation by the SEC and
various bodies formed to create and interpret appropriate
accounting principles and guidance. A change in these principles or
guidance, or in their interpretations, may have a material effect
on our reported results, as well as our processes and related
controls, and may retroactively affect previously reported
results.
Our revenue recognition and other factors may impact our financial
results in any given period and make them difficult to
predict.
We recognize revenue when our performance obligations have been
satisfied in an amount that reflects the consideration that we
expect to receive in exchange for those performance obligations.
Our revenue includes revenue from the sale of manufactured
products, including products that can be purchased out of a catalog
and custom manufactured products, and services, including custom
antibody and assay development contracts, antibody affinity
extraction and stability and feasibility studies, as well as
certain licensing and royalty arrangements. The majority of our
contracts include only one performance obligation, namely the
delivery of products, both custom and catalog, and services. We
also recognize revenue from other contracts that may include a
combination of products and services, the provision of solely
services, or from license fee arrangements which may be associated
with the delivery of product. Our application of the revenue
recognition accounting
guidance with respect to the nature of future contractual
arrangements could impact the forecasting of our revenue for future
periods, as both the mix of products and services we will sell in a
given period, as well as the size of contracts, is difficult to
predict.
Furthermore, the presentation of our financial results requires us
to make estimates and assumptions that may affect revenue
recognition. In some instances, we could reasonably use different
estimates and assumptions, and changes in estimates may occur from
period to period. See Part II, Item 7, “Management’s Discussion and
Analysis of Financial Condition and Results of Operations—Critical
Accounting Estimates—Revenue Recognition.”
Given the foregoing factors, comparing our revenue and operating
results on a period-to-period basis may not be meaningful, and our
past results may not be indicative of our future
performance.
Fluctuations in our effective tax rate may adversely affect our
results of operations and cash flows.
We are subject to a variety of tax liabilities, including federal,
state, foreign and other taxes such as income, sales/use, payroll,
withholding, and
ad valorem
taxes. Changes in tax laws or their interpretations could decrease
our net income, the value of any tax loss carryforwards, the value
of tax credits recorded on our balance sheet and our cash flows,
and accordingly could have a material adverse effect on our
business, financial condition, results of operations, cash flows
and prospects. In addition, our tax liabilities are subject to
periodic audits by the relevant taxing authority, which could
increase our tax liabilities.
Our business is subject to a number of environmental
risks.
Our manufacturing business involves the controlled use of hazardous
materials and chemicals and is therefore subject to numerous
environmental and safety laws and regulations and to periodic
inspections for possible violations of these laws and regulations.
The costs of compliance with environmental and safety laws and
regulations are significant. Any violations, even if inadvertent or
accidental, of current or future environmental and safety laws or
regulations and the cost of compliance with any resulting order or
fine could adversely affect our operations.
Risks Related to Our Reliance on Third Parties
We depend on a limited number of customers for a high percentage of
our revenue. If we cannot maintain our current relationships with
customers, fail to sustain recurring sources of revenue with our
existing customers, or if we fail to enter into new relationships,
our future operating results will be adversely
affected.
Revenue from our largest customers were 63.7%, 68.1% and 34.3% of
total revenue for the years ended December 31, 2022, 2021 and
2020, respectively. The revenue attributable to our top customers
has fluctuated in the past and may fluctuate in the future, which
could have a material adverse effect on our business, financial
condition, results of operations, cash flows and prospects. In
addition, the termination of these relationships, including
following any failure to renew a long-term contract, could result
in a temporary or permanent loss of revenue. See also
“—The
extent and duration of our revenue associated with COVID-19 related
products and services are uncertain and are dependent, in important
respects, on factors outside our control.”
Our future success depends on our ability to maintain these
relationships, to increase our penetration among these existing
customers and to establish new relationships. We engage in
conversations with other companies and institutions regarding
potential commercial opportunities on an ongoing basis, which can
be time consuming. There is no assurance that any of these
conversations will result in a commercial agreement, or if an
agreement is reached, that the resulting relationship will be
successful. Speculation in the industry about our existing or
potential commercial relationships can be a catalyst for adverse
speculation about us, our products, our services and our
technology, which can adversely affect our reputation and our
business. In addition, if our customers order our products or
services, but fail to pay on time or at all, our liquidity,
financial condition, results of operations, cash flows and
prospects could be materially and adversely affected.
We cannot assure investors that we will be able to further
penetrate our existing markets or that our products or services
will gain adequate market acceptance. Any failure to increase
penetration in our existing markets would adversely affect our
ability to improve our operating results.
We may enter into additional distribution arrangements and
marketing alliances for certain products and services and any
failure to successfully identify and implement these arrangements
on favorable terms, if at all, may impair our ability to
effectively distribute and market our products.
We may pursue additional arrangements regarding the sales and
marketing and distribution of one or more of our products and
services and our future revenue may depend, in part, on our ability
to enter into and maintain arrangements with other companies having
sales, marketing and distribution capabilities and the ability of
such companies to successfully market and
sell any such products and services. Any failure to enter into such
arrangements and marketing alliances on favorable terms, if at all,
could delay or impair our ability to distribute or market our
products and services and could increase our costs of distribution
and marketing. Any use of distribution arrangements and marketing
alliances to commercialize our products and services will subject
us to a number of risks, including the following:
•we
may be required to relinquish important rights to our
products;
•we
may not be able to control the amount and timing of resources that
our distributors or collaborators may devote to the distribution or
marketing of our products;
•our
distributors or collaborators may experience financial
difficulties; and
•business
combinations or significant changes in a collaborator’s business
strategy may adversely affect a collaborator’s willingness or
ability to complete its obligations under any
arrangement.
We rely on a limited number of suppliers or, in some cases, sole
suppliers, for some of our raw materials and may not be able to
find replacements or immediately transition to alternative
suppliers.
Certain of our raw materials are sourced from a limited number of
suppliers and some materials, including a proprietary DNA reagent,
certain packaging materials, specific cell lines for Cygnus
Technologies’ operations and certain raw materials used in our
nucleic acid production products, as well as those raw materials
sold under the Glen Research brand, are sole sourced. Delays or
difficulties in securing these raw materials or other laboratory
materials could result in an interruption in our production
operations if we cannot obtain an acceptable substitute. Since the
onset of the COVID-19 pandemic, global supply chains have faced
challenges, including material availability, global logistics
delays and constraints arising from, among other things, the
transportation capacity of ocean shipping containers, and these
challenges have been exacerbated by the ongoing macroeconomic
conditions as discussed above. Any interruption of our supply chain
could significantly affect our business, financial condition,
results of operations, cash flows and prospects. While we may
identify other suppliers, raw materials furnished by such
replacement suppliers may require us to alter our production
operations or perform extensive validations, which may be time
consuming and expensive. There can be no assurance that we will be
able to secure alternative materials and revalidate them without
experiencing interruptions in our workflow. If we should encounter
delays or difficulties in obtaining raw materials, our business,
financial condition, results of operations, cash flows and
prospects could be adversely affected.
We depend on a stable and adequate supply of quality raw materials
from our suppliers, and price increases or interruptions of such
supply could have an adverse impact on our business, financial
condition, results of operations, cash flows and
prospects.
Our operations depend upon our ability to obtain raw materials at
reasonable prices. Cost and wage inflation, ongoing supply
disruptions and logistics capacity constraints have increased, or
may increase, our costs to manufacture and distribute our products
and services. If we are unable to obtain the materials we need at a
reasonable price due to inflationary pressures or other factors, we
may not be able to produce certain of our products at marketable
prices or at all, which could have a material adverse effect on our
results of operations.
Although we believe that we have stable relationships with our
existing suppliers, we cannot assure you that we will be able to
secure a stable supply of raw materials going forward. Our
suppliers may not be able to keep up with our pace of growth or may
reduce or cease their supply of raw materials to us at any time. In
addition, we cannot assure you that our suppliers have obtained and
will be able to obtain or maintain all licenses, permits and
approvals necessary for their operations or comply with all
applicable laws and regulations, and failure to do so by them may
lead to interruption in their business operations, which in turn
may result in shortages of raw materials supplied to us. Some of
our suppliers are based overseas and therefore may need to maintain
export or import licenses. If the supply of raw materials is
interrupted, due to ongoing supply chain disruptions or other
factors, our business, financial condition, results of operations,
cash flows and prospects may be adversely affected.
Because we rely heavily on third-party package-delivery services, a
significant disruption in these services, damages or losses
sustained during shipping or significant increases in prices could
adversely affect our business, financial condition, results of
operations, cash flows and prospects.
We ship a significant portion of our products to our customers
through independent package delivery companies, such as World
Courier, FedEx, UPS and DHL. If one or more of these third-party
package-delivery providers were to experience a major work
stoppage, preventing our products from being delivered in a timely
fashion or causing us to incur additional shipping costs we could
not pass on to our customers, our costs could increase and our
relationships with certain of our customers could be adversely
affected. In addition, if one or more of these third-party
package-delivery providers were to increase prices, and we were not
able to find comparable alternatives or make adjustments in our
delivery network, our profitability could be adversely affected.
Furthermore, if one or more of these third-party package-delivery
providers were to experience performance problems
or other difficulties, it could negatively impact our operating
results and our customers’ experience. In the past, some of our
products have sustained serious damage in transit such that they
were no longer usable. Although we have taken steps to improve our
packaging and shipping containers, there is no guarantee our
products will not become damaged or lost in transit in the future.
If our products are damaged or lost in transit, it may result in a
substantial delay in the fulfillment of our customer’s order and,
depending on the type and extent of the damage, it may result in a
substantial financial loss. If our products are not delivered in a
timely fashion or are damaged or lost during the delivery process,
our customers could become dissatisfied and cease using our
products or our services, which would adversely affect our
business, financial condition, results of operations, cash flows
and prospects.
Risks Related to Laws and Regulations
Our products could become subject to more onerous regulation by the
FDA or other regulatory agencies in the future, which could
increase our costs and delay or prevent commercialization of our
products, thereby materially and adversely affecting our business,
financial condition, results of operations, cash flows and
prospects.
We make certain of our products available to customers as
research-use-only (“RUO”) products. RUO products are regulated by
the FDA as medical devices, and include
in vitro
diagnostic products in the laboratory research phase of development
that are being shipped or delivered for an investigation that is
not subject to the FDA’s investigational device exemption
requirements. Although medical devices are subject to stringent FDA
oversight, products that are intended for RUO and are labeled as
RUO are exempt from compliance with most FDA requirements,
including premarket clearance or approval, manufacturing
requirements, and others. A product labeled RUO but which is
actually intended for clinical diagnostic use may be viewed by the
FDA as adulterated and misbranded under the FDCA, and subject to
FDA enforcement action. The FDA has indicated that when determining
the intended use of a product labeled RUO, the FDA will consider
the totality of the circumstances surrounding distribution and use
of the product, including how the product is marketed and to whom.
The FDA could disagree with our assessment that our products are
properly marketed as RUO, or could conclude that products labeled
as RUO are actually intended for clinical diagnostic use, and could
take enforcement action against us, including requiring us to stop
distribution of our products until we are in compliance with
applicable regulations, which would reduce our revenue, increase
our costs and adversely affect our business, prospects, results of
operations and financial condition. In the event that the FDA
requires us to obtain marketing authorization of our RUO products
in the future, there can be no assurance that the FDA will grant
any clearance or approval requested by us in a timely manner, or at
all.
Our raw material products are manufactured following the voluntary
quality standards of ISO 9001:2015. Our GMP-grade raw material
products follow ISO 9001:2015 standards, additional voluntary GMP
quality standards and customer specific requirements. We believe
these raw material products, including our GMP-grade raw material
products, are exempt from compliance with the FDCA and the cGMP
regulations of the FDA, as our products are further processed by
our customers and we do not make claims related to their safety or
effectiveness. We provide API products to customers for use in
preclinical studies through and including clinical trials. Our API
products are manufactured following the principles detailed in the
International Council for Harmonisation (ICH) Q7, Good
Manufacturing Practice Guide for Active Pharmaceutical Ingredients
(Section 19, APIs For Use in Clinical Trials) in order to comply
with the applicable requirements of the FDCA, and the comparable
GMP principles for Europe; European Community, Part II, Basic
Requirements for Active Substances Used as Starting Materials
(Section 19, APIs For Use in Clinical Trials). Manufacture of APIs
for use in clinical trials is regulated under § 501(a)(2)(B) of the
FDCA, but is not subject to the current GMP regulations in 21 CFR §
211 by operation of 21 CFR § 210. Our API products are provided to
customers under customer contracts that outline quality standards
and product specifications. As products advance through the
clinical phases, requirements become more stringent and we work
with customers to define and agree on requirements and risks
associated with their product.
The FDA could disagree with our assessment that our products are
exempt from current GMP regulations. In addition, the FDA could
conclude that the raw material and API products we provide to our
customers are actually subject to the pharmaceutical or drug
quality-related regulations for manufacturing, processing, packing
or holding of drugs or finished pharmaceuticals, and could take
enforcement action against us, including requiring us to stop
distribution of our products until we are in compliance with
applicable regulations, which would reduce our revenue, increase
our costs and adversely affect our business, prospects, results of
operations and financial condition. In the event that the FDA
requires us to comply with FDA regulations, for our raw material
and API products in the future, including the FDA’s current GMP
regulations, there can be no assurance that the FDA will find our
operations are in compliance in a timely manner, or at
all.
We are subject to stringent privacy laws, information security
laws, regulations, policies and contractual obligations related to
data privacy and security and changes in such laws, regulations,
policies and contractual obligations could adversely affect our
business, financial condition, results of operations, cash flows
and prospects.
We are subject to data privacy and protection laws and regulations
that apply to the collection, transmission, storage and use of
proprietary information and personally identifiable information
(“PII”), which among other things, imposes certain requirements
relating to the privacy, security and transmission of certain
individually identifiable information.
Numerous other federal and state laws, including state security
breach notification laws, state health information privacy laws and
federal and state consumer protection laws, govern the collection,
use, disclosure and security of personal information. These laws
continue to change and evolve and are increasing in breadth and
impact. Failure to comply with any of these laws and regulations
could result in enforcement action against us, including fines,
imprisonment of company officials and public censure, claims for
damages by affected individuals, damage to our reputation and loss
of goodwill, any of which could have a material adverse effect on
our business, financial condition, results of operations, cash
flows and prospects. Additionally, if we are unable to properly
protect the privacy and security of personal information, we could
be found to have breached our contracts.
Many states in which we operate have laws that protect the privacy
and security of personal information. For example, the California
Consumer Privacy Act of 2018 (“CCPA”), which increases privacy
rights for California residents and imposes obligations on
companies that process their personal information, came into effect
on January 1, 2020. Among other things, the CCPA requires covered
companies to provide new disclosures to California consumers and
provide such consumers new data protection and privacy rights,
including the ability to opt-out of certain sales of personal
information. The CCPA provides for civil penalties for violations,
as well as a private right of action for certain data breaches that
result in the loss of personal information. Further, the California
Privacy Rights Act (the “CPRA”), which took effect on January 1,
2023 (with certain provisions having retroactive effect to January
1, 2022), amended the CCPA. Amongst other things, the CPRA and
eliminated the “employee exemption” under the CCPA, makes a
distinction between “personal information” and “sensitive personal
information,” imposing heightened protections for “sensitive
personal information,” and brings business-to-business transactions
under its purview. These laws and others like it are yet to be
tested and may subject us to increased regulatory scrutiny,
litigation, and overall risk. Further, there is discussion in
Congress of a new federal data protection and privacy law to which
we would become subject, if it is enacted.
Various foreign countries in which we operate also have, or are
developing, laws that govern the collection, use, disclosure,
security and cross-border transmission of personal information. For
example, in the European Union (the “EU”) and the United Kingdom,
the collection and use of personal data is governed by the
provisions of the General Data Protection Regulation (“GDPR”), in
addition to other applicable laws and regulations. The GDPR came
into effect in May 2018,and has resulted in, and will continue to
result in, significantly greater compliance burdens and costs for
companies like us. Any data security breach could require
notifications to the data subject and/or owners under U.S. federal,
U.S. state, and/or international data breach notification laws and
regulations. Other jurisdictions outside the EU are similarly
introducing or enhancing privacy and data security laws, rules and
regulations, which could increase our compliance costs and the
risks associated with noncompliance. We cannot guarantee that we
are, or will be, in compliance with all applicable international
regulations as they are enforced now or as they
evolve.
It is possible that these laws may be interpreted and applied in a
manner that is inconsistent with our practices and our efforts to
comply with the evolving data protection rules may be unsuccessful.
We must devote significant resources to understanding and complying
with this changing landscape. Failure to comply with federal, state
and international laws regarding privacy and security of personal
information could expose us to penalties under such laws, orders
requiring that we change our practices, claims for damages or other
liabilities, regulatory investigations and enforcement action,
litigation and significant costs for remediation, any of which
could adversely affect our business. Even if we are not determined
to have violated these laws, government investigations into these
issues typically require the expenditure of significant resources
and generate negative publicity, which have a material adverse
effect on our business, financial condition, results of operations,
cash flows and prospects.
We are subject to export and import control laws and regulations
that could impair our ability to compete in international markets
or subject us to liability if we violate such laws and
regulations.
We are subject to U.S. export controls and sanctions regulations
that restrict the shipment or provision of certain products and
services to certain countries, governments and persons. While we
take precautions to prevent our products and services from being
exported in violation of these laws, we cannot guarantee that the
precautions we take will prevent violations of export control and
sanctions laws. If we are found to be in violation of U.S.
sanctions or export control laws, it could result in substantial
fines and penalties for us and for the individuals working for us.
We may also be adversely affected through other penalties,
reputational harm, loss of access to certain markets, or otherwise.
Complying with export control and sanctions
regulations may be time consuming and may result in the delay or
loss of sales opportunities or impose other costs. Any change in
export or import regulations, economic sanctions or related
legislation, or change in the countries, governments, persons or
technologies targeted by such regulations, could result in our
decreased ability to export or sell certain products and services
to existing or potential customers in affected
jurisdictions.
Changes in political, economic or governmental regulations may
reduce demand for our products and services or increase our
expenses.
We compete in many markets in which we and our customers must
comply with federal, state, local and international regulations,
such as environmental, health and safety and food and drug
regulations. We develop, configure and market our products and
services to meet customer needs created by those regulations. The
U.S. and international healthcare industry is subject to changing
political, economic and regulatory influences that could
significantly affect the drug development process, research and
development costs and the pricing and reimbursement for
pharmaceutical products, and also may increase the likelihood of
legislative or regulatory changes that could impact us or our
business operations. Any significant change in regulations could
have an adverse effect on both our customers’ business and our
business, which could result in reduced demand for our products and
services or increases in our expenses. For example, we provide
products and services used for basic research, raw materials used
by biopharmaceutical customers for further processing, and active
pharmaceutical ingredients used for preclinical studies and
clinical trials.
Changes in the FDA’s regulation of the drug discovery and
development process may have a negative impact on the ability of
our customers to conduct and fund clinical trials, which could have
a material adverse effect on the demand for the products and
services we provide these customers. Additionally, the U.S.
government and governments worldwide have increased efforts to
expand healthcare coverage while at the same time curtailing and
better controlling the increasing costs of healthcare. If
cost-containment efforts limit our customers’ profitability, they
may decrease research and development spending, which could
decrease the demand for our products and services and materially
adversely affect our growth prospects. Any of these factors could
harm our customers’ businesses, which, in turn, could materially
adversely hurt our business, financial condition, results of
operations, cash flows and prospects.
We are subject to financial, operating, legal and compliance risk
associated with global operations.
We engage in business globally, with approximately 62%, 60% and 47%
of our revenue for the years ended December 31, 2022, 2021 and
2020, respectively, coming from outside the U.S. In addition, one
of our strategies is to expand geographically, both through
distribution and through direct sales. This subjects us to a number
of risks, including international economic, political, and labor
conditions; currency fluctuations; tax laws (including U.S. taxes
on income earned by foreign subsidiaries); increased financial
accounting and reporting burdens and complexities; unexpected
changes in, or impositions of, legislative or regulatory
requirements; failure of laws to protect intellectual property
rights adequately; inadequate local infrastructure and difficulties
in managing and staffing international operations; delays resulting
from difficulty in obtaining export licenses for certain
technology; tariffs, quotas and other trade barriers and
restrictions; transportation delays; operating in locations with a
higher incidence of corruption and fraudulent business practices;
and other factors beyond our control, including terrorism, war,
natural disasters, climate change and diseases.
The application of laws and regulations implicating global
transactions is often unclear and may at times conflict. Compliance
with these laws and regulations may involve significant costs or
require changes in our business practices that result in reduced
revenue and profitability. Non-compliance could also result in
fines, damages, criminal sanctions, prohibited business conduct,
and damage to our reputation. We incur additional legal compliance
costs associated with our global operations and could become
subject to legal penalties in foreign countries if we do not comply
with local laws and regulations, which may be substantially
different from those in the U.S.
We may expand our operations in countries with developing
economies, where it may be common to engage in business practices
that are prohibited by anti-corruption and anti-bribery laws and
regulations that apply to us, such as the U.S. Foreign Corrupt
Practices Act (“FCPA”), the U.S. Travel Act, and the UK Bribery Act
2010, which prohibit improper payments or offers of payment to
foreign governments and political parties by us for the purpose of
obtaining or retaining business. Although we implement policies and
procedures designed to ensure compliance with these laws, there can
be no assurance that all of our employees, contractors,
distributors and agents, including those based in foreign countries
where practices which violate such U.S. laws may be customary, will
comply with our internal policies. Any such non-compliance, even if
prohibited by our internal policies, could have an adverse effect
on our business and result in significant fines or
penalties.
Our activities are and will continue to be subject to extensive
government regulation, which is expensive and time
consuming.
We are subject to various local, state, federal, foreign and
transnational laws and regulations, and, in the future, any changes
to such laws and regulations could adversely affect
us.
We provide products and services used for basic research, raw
materials and life science reagents used by biopharmaceutical
customers for further processing, assays for biologics safety
testing and active pharmaceutical ingredients used for preclinical
studies and clinical trials. The quality of our products and
services is critical to researchers looking to develop novel
vaccines and therapies and for biopharmaceutical customers who use
our products as raw materials or who are engaged in preclinical
studies and clinical trials. Biopharmaceutical customers are
subject to extensive regulations by the FDA and similar regulatory
authorities in other countries for conducting clinical trials and
commercializing products for therapeutic or diagnostic use. This
regulatory scrutiny results in our customers imposing rigorous
quality requirements on us as their supplier through supplier
qualification processes and customer contracts.
Additionally, regulatory authorities and our customers may conduct
scheduled or unscheduled periodic inspections of our facilities to
monitor our regulatory compliance or compliance with our quality
agreements with our customers. There are significant risks at each
stage of the regulatory scheme for our customers.
Regulatory agencies may in the future take action against us or our
customers for failure to comply with applicable regulations
governing clinical trials and the development and testing of
therapeutic products. Failure by us or by our customers to comply
with the requirements of these regulatory authorities, including
without limitation, remediating any inspectional observations to
the satisfaction of these regulatory authorities, could result in
warning letters, product recalls or seizures, monetary sanctions,
injunctions to halt manufacture and distribution, restrictions on
our operations, civil or criminal sanctions, or withdrawal of
existing or denial of pending approvals, including those relating
to products or facilities. In addition, such a failure could expose
us to contractual or product liability claims, contractual claims
from our customers, including claims for reimbursement for lost or
damaged active pharmaceutical ingredients, as well as ongoing
remediation and increased compliance costs, any or all of which
could be significant.
We are also subject to a variety of federal, state, local and
international laws and regulations that govern, among other things,
the importation and exportation of products, the handling,
transportation and manufacture of substances that could be
classified as hazardous, and our business practices in the U.S. and
abroad such as anti-corruption and anti-competition laws. Any
noncompliance by us with applicable laws and regulations or the
failure to maintain, renew or obtain necessary permits and licenses
could result in criminal, civil and administrative penalties and
could have an adverse effect on our results of
operations.
Increasing scrutiny and changing expectations from investors,
lenders, customers, government regulators and other market
participants with respect to our Environmental, Social and
Governance (“ESG”) policies and activities may impose additional
costs on us or expose us to additional risks.
Companies across all industries and around the globe are facing
increasing scrutiny relating to their ESG policies, initiatives and
activities by investors, lenders, customers, government regulators
and other market participants. In particular, these constituencies
are increasingly focusing on environmental stewardship, including
climate change, water use, deforestation, waste, and other
sustainability concerns, as well as diversity and inclusion,
workplace conduct, support for local communities, and other human
capital and social issues.
There is no guarantee that any ESG or sustainability goals set
forth in our ESG initiatives will be achieved on the desired
timeframe or at all, and the achievement of any such goals may
require the incurrence of additional costs or the implementation of
operational changes, any of which could adversely affect the
Company’s results of operations.
Additionally, changes in legal and regulatory requirements related
to ESG have been issued in the E.U., its Member States and other
countries, particularly with respect to climate change, emission
reduction and environmental stewardship in the U.S., amongst other
regulatory efforts, the SEC has proposed rules to enhance and
standardize climate-related disclosures in public company filings.
We expect legal, regulatory and reporting requirements related to
ESG matters to continue to expand globally and increase our costs
of compliance.
If we are unable to meet our ESG initiatives or evolving investor,
industry, or customer expectations and standards, or we are
perceived to have not responded adequately on any number of ESG
matters, we risk damage to our brand and reputation, adverse
impacts to our ability to secure government contracts, decreased
desirability of our common stock to investors, or limited access to
capital markets and other sources of financing.
Risks Related to Our Intellectual Property and
Technology
If we are unable to obtain, maintain and enforce intellectual
property protection for our current or future products, or if the
scope of our intellectual property protection is not sufficiently
broad, our ability to commercialize our products successfully and
to compete effectively may be materially adversely
affected.
Our success depends on our ability to obtain and maintain patent
and other intellectual property protection in the United States and
other countries with respect to our current and future proprietary
products. We rely upon a combination of patents and trade secret
protection to protect the intellectual property related to our
technology, manufacturing processes, and products. Our commercial
success depends in part on obtaining and maintaining patent and
trade secret protection of our current and future products, if any,
and the methods used to manufacture them, as well as successfully
defending such patents and trade secrets against third-party
challenges. Our ability to stop third parties from making, using,
selling, offering to sell or importing our products is dependent
upon the extent to which we have rights under valid and enforceable
patents and other intellectual property that covers these
activities.
The patent prosecution process is expensive and time consuming, and
we may not be able to file and prosecute all necessary or desirable
patent applications at a reasonable cost or in a timely manner or
in all jurisdictions where protection may be commercially
advantageous. It is also possible that we may fail to identify
patentable aspects of our research and development output before it
is too late to obtain patent protection. In addition, we or our
collaborators may only pursue, obtain or maintain patent protection
in a limited number of countries. There is no assurance that all
potentially relevant prior art relating to our patents and patent
applications has been found. We may be unaware of prior art that
could be used to invalidate or narrow the scope of an issued patent
or prevent our pending patent applications from issuing as patents.
Because patent applications in the United States, Europe and many
other non-U.S. jurisdictions are typically not published until 18
months after filing, or in some cases not at all, because
publications of discoveries in scientific literature lag behind
actual discoveries, and because we cannot be certain that we or our
licensors were the first to make the inventions claimed in any of
our owned or any in-licensed issued patents or pending patent
applications, or that we or our licensors were the first to file
for protection of the inventions set forth in our patents or patent
applications. As a result, we may not be able to obtain or maintain
protection for certain inventions. Even if patents do successfully
issue, such patents may not adequately protect our intellectual
property, provide exclusivity for our current or future products,
prevent others from designing around our claims or otherwise
provide us with a competitive advantage. We cannot offer any
assurances about which, if any, patents will issue, the breadth of
any such patents or whether any issued patents will be found
invalid or unenforceable or will be threatened by third parties. In
addition, third parties may challenge the validity, enforceability,
ownership, inventorship or scope of any of our patents. Any
successful challenge to any of our patents could deprive us of
rights necessary for the successful commercialization of our
current or future products and could impair or eliminate our
ability to collect future revenue and royalties with respect to
such products. If any of our patent applications with respect to
our current or future products fail to result in issued patents, if
their breadth or strength of protection is narrowed or threatened,
or if they fail to provide meaningful exclusivity or competitive
position, it could dissuade companies from collaborating with us or
otherwise adversely affect our competitive position.
The patent positions of life science companies can be highly
uncertain and involve complex legal and factual questions for which
important legal principles remain unresolved. No consistent policy
regarding the breadth of claims allowed in life science patents has
emerged to date in the United States. The standards applied by the
United States Patent and Trademark Office (the “USPTO”) and foreign
patent offices in granting patents are not always applied uniformly
or predictably and can change. Additionally, the laws of some
foreign countries do not protect intellectual property rights to
the same extent as the laws of the United States, and many
companies have encountered significant problems in protecting and
defending such rights in foreign jurisdictions. The legal systems
of certain countries, particularly certain developing countries, do
not favor the enforcement of patents and other intellectual
property rights, particularly those relating to biotechnology,
which could make it difficult for us to stop the infringement,
misappropriation, or other violation of our patents or other
intellectual property, including the unauthorized reproduction of
our manufacturing or other know-how or the marketing of competing
products in violation of our intellectual property rights
generally. Any of these outcomes could impair our ability to
prevent competition from third parties, which may have a material
adverse effect on our business, financial condition, results of
operations, cash flows and prospects.
Further, the existence of issued patents does not guarantee our
right to practice the patented technology or commercialize products
covered by such a patent. Third parties may have or obtain rights
to patents which they may use to prevent or attempt to prevent us
from practicing our patented technology or commercializing our
patented products. If any of these other parties are successful in
obtaining valid and enforceable patents, and establishing our
infringement of those patents, we could be prevented from selling
our products unless we were able to obtain a license under such
third-party patents, which may not be available on commercially
reasonable terms or at all. In addition, third parties may seek
approval to market their own products similar to or otherwise
competitive with our products. In these circumstances, we may need
to defend or assert our patents, including by filing lawsuits
alleging patent infringement. In any of these types of proceedings,
a court or agency of competent jurisdiction may find our patents
invalid or unenforceable. Our competitors and other third parties
may also be able to
circumvent our patents by developing similar or alternative
products in a non-infringing manner. Any of the foregoing could
have a material adverse effect on our business, financial
condition, results of operations, cash flows and
prospects.
In addition, competitors may use our technologies in jurisdictions
where we have not obtained or are unable to adequately enforce
patent protection to develop their own products and further, may
export otherwise infringing products to territories where we have
patent protection, but enforcement is not as strong as that in the
United States and Europe. These products may compete with our
products, and our patents or other intellectual property rights may
not be effective or sufficient to prevent them from competing with
us. Proceedings to enforce our patent rights, whether or not
successful, could result in substantial costs and divert our
efforts and attention from other aspects of our business, could put
our patents at risk of being invalidated or held unenforceable, or
interpreted narrowly and our patent applications at risk of not
issuing, and could provoke third parties to assert claims against
us. We may not prevail in any lawsuits that we initiate, and the
damages or other remedies awarded, if any, may not be commercially
meaningful. Accordingly, our efforts to enforce our intellectual
property rights around the world may be inadequate to obtain a
significant commercial advantage from the intellectual property
that we develop, acquire or license.
Intellectual property that we own or in-license may be subject to a
reservation of rights by one or more third parties. For example,
one of our patents is co-owned with third parties and some of our
patent rights in the future may be co-owned with third parties. If
we are unable to obtain an exclusive license to any such
third-party co-owners’ interest in such patent rights, such
co-owners may be able to license their rights to other third
parties, including our competitors, and our competitors could
market competing products and technology. In addition, we may need
the cooperation of any such co-owners of such patent rights in
order to enforce such patent rights against third parties, and such
cooperation may not be provided to us. Any of the foregoing could
have a material adverse effect on our competitive position,
business, financial conditions, results of operations, and
prospects.
Moreover, the research resulting in certain of our patents and
technology was funded in part by the U.S. government. As a result,
the U.S. government has certain rights to such patent rights and
technology, which include march-in rights. When new technologies
are developed with government funding, in order to secure ownership
of such patent rights, the recipient of such funding is required to
comply with certain government regulations, including timely
disclosing the inventions claimed in such patent rights to the U.S.
government and timely electing title to such inventions.
Additionally, the U.S. government generally obtains certain rights
in any resulting patents, including a nonexclusive license
authorizing the government to use the invention or to have others
use the invention on its behalf. Accordingly, we or our licensors
have granted the U.S. government a nonexclusive, nontransferable,
irrevocable, paid-up license to practice or have practiced for or
on behalf of the United States, the inventions described in the
patents and patent applications relating to such inventions. If the
U.S. government decides to exercise these rights, it is not
required to engage us as its contractor in connection with doing
so. The government’s rights may also permit it to disclose our
confidential information to third parties and to exercise march-in
rights to use or allow third parties to use such government-funded
technology. The government can exercise its march-in rights if it
determines that action is necessary because we fail to achieve
practical application of the government-funded technology, or
because action is necessary to alleviate health or safety needs, to
meet requirements of federal regulations, or to give preference to
U.S. industry. In addition, our rights in such inventions may be
subject to certain requirements to manufacture products embodying
such inventions in the United States. If we fail to comply with
those requirements, we could lose our ownership of or other rights
to any patents subject to such regulations. Any exercise by the
government of any of the foregoing rights or by any third party of
its reserved rights could have a material adverse effect on our
competitive position, business, financial condition, results of
operations, and prospects.
Furthermore, patents have a limited lifespan. In the United States,
the unextended expiration of a patent is 20 years after its
non-provisional filing date. Various extensions may be available,
however, the life of a patent and the protection it affords is
limited. Given the amount of time required for the development,
testing, regulatory review and approval of new products, our
patents protecting such candidates might expire before or shortly
after such candidates are commercialized. If we encounter delays in
obtaining regulatory approvals, the period of time during which we
could market a product under patent protection could be further
reduced. Even if patents covering our future products are obtained,
once such patents expire, we may be vulnerable to competition from
similar products. The launch of a similar version of one of our
products would likely result in an immediate and substantial
reduction in the demand for our product. As a result, our patent
portfolio may not provide us with sufficient rights to exclude
others from commercializing products similar or identical to ours.
Any of the foregoing could have a material adverse effect on our
business, financial condition, results of operations, cash flows
and prospects.
If we are prevented from enforcing our intellectual property rights
because of governmental regulatory policies or political pressure
or action, our sales and profitability may be materially adversely
affected.
Our ability to maintain and grow our product sales and
profitability depends, in part, on our ability to maintain and
enforce our patents and other intellectual property rights.
Proposed actions to waive intellectual property protections for
COVID-19 vaccines and associated technology, such as those under
discussion at the World Trade Organization, which are supported by
the U.S. government, may impact our ability to fully assert our
intellectual property rights related to our CleanCap product
in
connection with the production of COVID-19 vaccines. Further, these
policy actions may complicate our analysis and decision-making with
respect to both research and development and capital investment,
given the potential for lower returns on those investments that
could result from our inability to fully protect our intellectual
property. If we are unable to successfully navigate these
considerations, the future revenues and profitability of our
business could be negatively impacted. We are unable to estimate
the impact of these potential policies given that they remain
undefined and their adoption is uncertain.
Our internal computer systems, or those of our customers,
collaborators or other contractors, have been and may in the future
be subject to cyber-attacks or security breaches, which could
result in a material disruption of our product development programs
or otherwise adversely affect our business, financial condition,
results of operations, cash flows and prospects.
Despite the implementation of security measures, our internal
computer systems and those of our customers are vulnerable to
damage from computer viruses and unauthorized access. Cyber-attacks
are increasing in their frequency, sophistication and intensity,
and have become increasingly difficult to detect. Cyber-attacks
could include the deployment of harmful malware, ransomware,
denial-of-service attacks, social engineering and other means to
affect service reliability and threaten the confidentiality,
integrity and availability of information. Cyber-attacks also could
include phishing attempts or e-mail fraud to cause unauthorized
payments or information to be transmitted to an unintended
recipient. A material cyber-attack or security breach could cause
interruptions in our operations and could result in a material
disruption of our business operations, damage to our reputation,
financial condition, results of operations, cash flows and
prospects.
In the ordinary course of our business, we collect and store
sensitive data, including, among other things, personally
identifiable information about our employees, intellectual
property, and proprietary business information. Any cyber-attack or
security breach that leads to unauthorized access, use or
disclosure of personal or proprietary information could harm our
reputation, cause us not to comply with federal and/or state breach
notification laws and foreign law equivalents and otherwise subject
us to liability under laws and regulations that protect the privacy
and security of personal information. In addition, we could be
subject to risks caused by misappropriation, misuse, leakage,
falsification or intentional or accidental release or loss of
information maintained in the information systems and networks of
our company and our vendors, including personal information of our
employees, and company and vendor confidential data. In addition,
outside parties have previously attempted and may in the future
attempt to penetrate our systems or those of our vendors or
fraudulently induce our personnel or the personnel of our vendors
to disclose sensitive information in order to gain access to our
data and/or systems or make unauthorized payments to third parties.
Like other companies, we have on occasion experienced, and will
continue to experience, data security incidents involving access to
company data, unauthorized payments and threats to our data and
systems, including malicious codes and viruses, phishing, business
email compromise attacks, or other cyber-attacks. The number and
complexity of these threats continue to increase over time. If a
material breach of our information technology systems or those of
our vendors occurs, the market perception of the effectiveness of
our security measures could be harmed and our reputation and
credibility could be damaged.
We could be required to expend significant amounts of money and
other resources to respond to these threats or breaches and to
repair or replace information systems or networks and could suffer
financial loss or the loss of valuable confidential information. In
addition, we could be subject to regulatory actions and/or claims
made by individuals and groups in private litigation involving
privacy issues related to data collection and use practices and
other data privacy laws and regulations, including claims for
misuse or inappropriate disclosure of data, as well as unfair or
deceptive practices. Although we develop and maintain systems and
controls designed to prevent these events from occurring, and we
have a process to identify and mitigate threats, the development
and maintenance of these systems, controls and processes is costly
and requires ongoing monitoring and updating as technologies change
and efforts to overcome security measures become increasingly
sophisticated. Moreover, despite our efforts, the possibility of
these events occurring cannot be eliminated entirely and there can
be no assurance that any measures we take will prevent
cyber-attacks or security breaches that could adversely affect our
business, financial condition, results of operations, cash flows
and prospects.
If we are unable to protect the confidentiality of our proprietary
information, the value of our technology and products could be
materially adversely affected.
We also may rely on trade secrets to protect our technology,
especially where we do not believe patent protection is appropriate
or obtainable. To maintain the confidentiality of trade secrets and
other proprietary information, we enter into confidentiality
agreements with our employees, consultants, contractors,
collaborators, CDMOs, CROs and others upon the commencement of
their relationships with us. These agreements require that all
confidential information developed by the individual or entity or
made known to the individual or entity by us during the course of
the individual’s or entity’s relationship with us be kept
confidential and not disclosed to third parties. Our agreements
with employees as well as our personnel policies also generally
provide that any inventions conceived by the individual in the
course of rendering services to us shall be our exclusive property
or that we may obtain full rights to such inventions at our
election. However, trade secrets are difficult to protect. Although
we
use reasonable efforts to protect our trade secrets, our employees,
consultants, contractors, collaborators, CDMOs, CROs and others may
unintentionally or willfully disclose our information to
competitors. We also face the risk that present or former employees
could continue to hold rights to intellectual property used by us,
demand the registration of intellectual property rights in their
name, and seek payment of damages for our use of such intellectual
property.
Enforcing a claim that a third party illegally obtained or is using
any of our trade secrets is expensive and time consuming, and the
outcome is unpredictable. We may not have adequate remedies in the
event of unauthorized use or disclosure of our trade secrets or
other proprietary information in the case of a breach of any such
agreements and our trade secrets and other proprietary information
could be disclosed to third parties, including our competitors.
Many of our partners also collaborate with our competitors and
other third parties. The disclosure of our trade secrets to our
competitors, or more broadly, would impair our competitive position
and may materially harm our business, financial condition, results
of operations, cash flows and prospects. Costly and time-consuming
litigation could be necessary to enforce and determine the scope of
our rights, and failure to maintain trade secret protection could
adversely affect our competitive business position. The
enforceability of confidentiality agreements may vary from
jurisdiction to jurisdiction. Courts outside the United States are
sometimes less willing to protect trade secrets. Moreover, our
competitors may independently develop substantially equivalent or
superior knowledge, methods and know-how, and the existence of our
own trade secrets affords no protection against such independent
discovery.
We may become involved in lawsuits to protect or enforce our
patents, which could be expensive, time-consuming and unsuccessful
and could result in a court or administrative body finding our
patents to be invalid or unenforceable.
Even if the patent applications we own or license are issued, third
parties may challenge or infringe upon our patents. To counter
infringement, we may be required to file infringement claims, which
can be expensive and time-consuming. In patent litigation in the
United States, defendant counterclaims alleging invalidity or
unenforceability are commonplace. Grounds for a validity challenge
could be an alleged failure to meet any of several statutory
requirements, including novelty, non-obviousness (or inventive
step), written description or enablement. In addition, patent
validity challenges may, under certain circumstances, be based upon
non-statutory obviousness-type double patenting, which, if
successful, could result in a finding that the claims are invalid
for obviousness-type double patenting or the loss of patent term if
a terminal disclaimer is filed to obviate a finding of
obviousness-type double patenting. Grounds for an unenforceability
assertion could be an allegation that someone connected with
prosecution of the patent withheld information material to
patentability from the USPTO, or made a misleading statement,
during prosecution.
Third parties may raise similar claims before administrative bodies
in the United States or abroad, even outside the context of
litigation. Such mechanisms include re-examination, post-grant
review,
inter partes
review, interference proceedings, derivation proceedings, and
equivalent proceedings in foreign jurisdictions (e.g., opposition
proceedings). Such proceedings could result in the revocation or
cancellation of or amendment to our patents in such a way that they
no longer cover our current or future products or provide any
competitive advantage. The outcome following legal assertions of
invalidity and unenforceability is unpredictable. If a third party
were to prevail on a legal assertion of invalidity or
unenforceability, we could lose part or all of the patent
protection on one or more of our current or future products, which
could result in our competitors and other third parties using our
technology to compete with us. Such a loss of patent protection
could have a material adverse impact on our business, financial
condition, results of operations, cash flows and
prospects.
Interference proceedings, or other similar enforcement and
revocation proceedings, provoked by third parties or brought by us
may be necessary to determine the priority of inventions with
respect to our patents or patent applications. An unfavorable
outcome could require us to cease using the related technology or
to attempt to license rights to it from the prevailing party. Our
business could be harmed if the prevailing party does not offer us
a license on commercially reasonable terms. Our defense of
litigation or interference proceedings may fail and, even if
successful, may result in substantial costs and distract our
management and other employees. We may not be able to prevent,
alone or with our licensors, infringement, misappropriation or
other violation of our intellectual property rights, particularly
in countries where the laws may not protect those rights as fully
as in the United States.
In an infringement proceeding, even one initiated by us, there is a
risk that a court will decide that our patents are not valid and
that we do not have the right to stop the other party from using
the inventions they describe. There is also the risk that, even if
the validity of such patents is upheld, the court will refuse to
stop the other party on the ground that such other party’s
activities do not infringe our rights to these
patents.
Some of our competitors may be able to sustain the costs of complex
patent litigation more effectively than we can because they have
substantially greater resources. In addition, any uncertainties
resulting from the initiation and continuation of any litigation
could have a material adverse effect on our ability to raise the
funds necessary to continue our operations. In addition, patent
holding companies that focus solely on extracting royalties and
settlements by enforcing patent rights may target us, especially as
we gain greater visibility and market exposure as a public
company.
An adverse outcome in a litigation or proceeding involving our
patents could limit our ability to assert our patents against
competitors, affect our ability to receive royalties or other
licensing consideration from our licensees, and may curtail or
preclude our ability to exclude third parties from making, using
and selling similar or competitive products. Any of these
occurrences could have a material adverse effect on our business,
financial condition, results of operations, cash flows and
prospects.
If we are sued for infringing, misappropriating, or otherwise
violating intellectual property rights of third parties, such
litigation could be costly and time consuming and could prevent or
delay us from developing or commercializing our current or future
products.
Our products may infringe on, or be accused of infringing on, one
or more claims of an issued patent or may fall within the scope of
one or more claims in a published patent application that may be
subsequently issued and to which we do not hold a license or other
rights.
Because patent applications in the United States and many foreign
jurisdictions are typically not published until 18 months after
filing, or in some cases not at all, and publications in the
scientific literature often lag behind actual discoveries, we
cannot be certain that others have not filed patent applications
for technology covered by our issued patents or our pending
applications, or that we were the first to invent the technology.
Others, including our competitors, may have filed, and may in the
future file, patent applications covering technology similar to
ours. Any such patent application may have priority over our patent
applications or patents, which could further require us to obtain
rights to issued patents by others covering such technologies. If
another party has filed a U.S. patent application on inventions
similar to ours, we may have to participate in an interference
proceeding declared by the USPTO to determine priority of invention
in the United States. The costs of these proceedings could be
substantial, and it is possible that such efforts would be
unsuccessful if, unbeknownst to us, the other party had
independently arrived at the same or similar invention prior to our
own invention, resulting in a loss of our U.S. patent position with
respect to such inventions.
Additionally, pending patent applications that have been published
can, subject to certain limitations, be later amended in a manner
that could cover our current or future products or the use of our
current or future products. After issuance, the scope of patent
claims remains subject to construction based on interpretation of
the law, the written disclosure in a patent and the patent’s
prosecution history. Our interpretation of the relevance or the
scope of a patent or a pending application may be incorrect. In
addition, third parties may obtain patents in the future and claim
that use of our technologies infringes upon these patents. These
third parties could bring claims against us or our collaborators
that would cause us to incur substantial expenses and, if
successful against us, could cause us to pay substantial
damages.
The life sciences industry has produced a proliferation of patents,
and it is not always clear to industry participants, including us,
which patents cover various types of products or methods of use.
The coverage of patents is subject to interpretation by the courts,
and the interpretation is not always uniform. If we are sued for
patent infringement, we would need to demonstrate that our products
or methods of use either do not infringe the patent claims of the
relevant patent and/or that the patent claims are invalid or
unenforceable, and we may not be able to do this. Proving
invalidity, in particular, is difficult since it requires a showing
of clear and convincing evidence to overcome the presumption of
validity enjoyed by issued patents. Third parties have, and may in
the future have, U.S. and non-U.S. issued patents and pending
patent applications that may cover our current or future products.
Such a third party may claim that we or our manufacturing or
commercialization partners are using inventions covered by the
third party’s patent rights and may go to court or a tribunal to
stop us from engaging in our normal operations and activities,
including making or selling our current or future products. In the
event that any of these patent rights were asserted against us, we
believe that we have defenses against any such action, including
that such patents would not be infringed by our current or future
products and/or that such patents are not valid. However, if any
such patent rights were to be asserted against us and our defenses
to such assertion were unsuccessful, unless we obtain a license to
such patents, we could be liable for damages, which could be
significant and include treble damages and attorneys’ fees if we
are found to willfully infringe such patents, and we could be
precluded from commercializing any future products that were
ultimately held to infringe such patents, any of which could have a
material adverse effect on our business, financial condition,
results of operations, cash flows and prospects.
If we are found to infringe the patent rights of a third party, or
in order to avoid potential claims, we or our collaborators may
choose or be required to seek a license from a third party and be
required to pay license fees or royalties or both. These licenses
may not be available on reasonable terms, or at all. In particular,
any of our competitors that control intellectual property that we
are found to infringe may be unwilling to provide us a license
under any terms. Even if we or our collaborators were able to
obtain a license, the rights may be nonexclusive, which could
result in our competitors gaining access to the same intellectual
property. Ultimately, we could be prevented from commercializing a
product, or be forced to cease some aspect of our business
operations, if, as a result of actual or threatened patent
infringement claims, we or our collaborators are unable to enter
into licenses on acceptable terms. In addition, we could be found
liable for monetary damages, including treble damages and
attorneys’ fees if we are found to have willfully infringed a
patent. Further, if a patent infringement suit is brought against
us or
our third-party service providers and if we are unable to
successfully obtain rights to required third-party intellectual
property, we may be required to expend significant time and
resources to redesign our current or future products, or to develop
or license replacement technology, all of which may not be feasible
on a technical or commercial basis, and may delay or require us to
abandon our development, manufacturing or sales activities relating
to our current or future products. A finding of infringement could
prevent us from commercializing our future products or force us to
cease some of our business operations, which could harm our
business. Claims that we have misappropriated the confidential
information or trade secrets of third parties could have a similar
negative impact on our business. Any of the foregoing could have a
material adverse effect on our business, financial condition,
results of operations, cash flows and prospects.
Intellectual property litigation and other proceedings could cause
us to spend substantial resources and distract our personnel from
their normal responsibilities.
Even if resolved in our favor, intellectual property litigation or
other legal proceedings relating to our, our licensors’ or other
third parties’ intellectual property claims may cause us to incur
significant expenses and could distract our personnel from their
normal responsibilities. Patent litigation and other proceedings
may also absorb significant management time. If not resolved in our
favor, litigation may require us to pay any portion of our
opponents’ legal fees. Such litigation or proceedings could
substantially increase our operating losses and reduce the
resources available for development activities or any future sales,
marketing, or distribution activities. We may not have sufficient
financial or other resources to conduct such litigation or
proceedings adequately. Our competitors or other third parties may
be able to sustain the cost of such litigation and proceedings more
effectively than we can because of their substantially greater
resources. Uncertainties resulting from our participation in patent
litigation or other proceedings could have a material adverse
effect on our ability to compete in the marketplace. Furthermore,
because of the substantial amount of discovery required in certain
jurisdictions in connection with intellectual property litigation,
there is a risk that some of our confidential information could be
compromised by disclosure during this type of litigation. There
could also be public announcements of the results of hearings,
motions or other interim proceedings or developments. If securities
analysts or investors perceive these results to be negative, the
perceived value of our current or future products or intellectual
property could be diminished. Accordingly, the market price of our
Class A common stock may decline. Uncertainties resulting from the
initiation and continuation of patent litigation or other
proceedings could have a material adverse effect on our business,
financial condition, results of operations, and
prospects.
If we fail to comply with our obligations under any license
agreements, disagree over contract interpretation, or otherwise
experience disruptions to our business relationships with our
licensors, we could lose intellectual property rights that are
necessary to our business.
We rely, in part, on intellectual property and technology which we
have in-licensed. We may also need to obtain additional licenses in
the future to advance our research or allow commercialization of
our future products and it is possible that we may be unable to do
so at a reasonable cost or on reasonable terms, if at all.
Moreover, such licenses may not provide exclusive rights to use
such intellectual property and technology in all relevant fields of
use and in all territories in which we may wish to develop or
commercialize our future products.
In addition, our existing license agreements impose, and any future
license agreements we enter into may impose, various development,
commercialization, funding, milestone, royalty, diligence,
sublicensing, insurance, patent prosecution and enforcement or
other obligations on us. Our license agreements, and any future
license agreement we enter into, may also impose restrictions on
our ability to license certain of our intellectual property to
third parties or to develop or commercialize certain current or
future products or technologies. In spite of our best efforts, our
counterparties may conclude that we have breached our obligations
under our agreements, or that we have used the intellectual
property licensed to us in an unauthorized manner, in which case,
we may be required to pay damages and the counterparty may have the
right to terminate the agreement. Any of the foregoing could result
in us being unable to develop, manufacture and sell products that
are covered by the licensed intellectual property or technology, or
enable a competitor to gain access to the licensed intellectual
property or technology.
We might not have the necessary rights or the financial resources
to develop, manufacture or market our current or future products
without the rights granted under our license agreements, and the
loss of sales or potential sales in current or future products
covered by such license agreements could have a material adverse
effect on our business, financial condition, results of operations,
cash flows and prospects.
Disputes may arise regarding intellectual property subject to
license agreements, including:
•the
scope of rights granted under the license agreement and other
interpretation related issues;
•the
extent to which our technology and processes infringe on
intellectual property of the licensor that is not subject to the
license agreement;
•the
sublicensing of patent and other rights under our collaborative
development relationships;
•our
diligence obligations under the license agreement and what
activities satisfy those diligence obligations;
•our
financial obligations under the license agreement;
•the
inventorship and ownership of inventions and know-how resulting
from the joint creation or use of intellectual property by our
licensors and us and our partners; and
•the
priority of invention of patented technology.
In addition, the agreements under which we currently license
intellectual property or technology to or from third parties are
complex, and certain provisions in such agreements may be
susceptible to multiple interpretations. The resolution of any
contract interpretation disagreement that may arise could narrow
what we believe to be the scope of our rights to the relevant
intellectual property or technology, or increase what we believe to
be our financial or other obligations under the relevant agreement,
either of which could have a material adverse effect on our
business, financial condition, results of operations, and
prospects. Moreover, if disputes over intellectual property that we
have licensed prevent or impair our ability to maintain our current
licensing arrangements on commercially acceptable terms, we may be
unable to successfully develop and commercialize the affected
future products.
In some cases, we may not have primary control over prosecution,
maintenance, enforcement and defense of patents and patent
applications that we have in-licensed from third parties, and
instead we rely on our licensors for these activities. We cannot be
certain that such activities have been or will be conducted in
compliance with applicable laws and regulations or in a manner
consistent with the best interests of our business. If we do
undertake any enforcement of our in-licensed patents or defense of
any claims asserting the invalidity of such patents, such actions
may be subject to the cooperation of our licensors or other third
parties. If our licensors or other third parties fail to prosecute,
maintain, enforce and defend intellectual property licensed to us,
or lose their own rights to such intellectual property, the rights
we have licensed may be impaired or eliminated and our ability to
develop and commercialize any of our products that are subject to
such rights could be adversely affected.
In-licensing or acquisition of third-party intellectual property is
a competitive area and a number of more established companies are
also pursuing strategies to in-license or acquire third-party
intellectual property rights that we may consider attractive or
necessary for our business. These companies may have a competitive
advantage over us due to their size, cash resources and greater
capabilities with respect to clinical development and
commercialization. Furthermore, companies that perceive us as a
competitor may be unwilling to assign or license rights to us. If
we are unable to successfully obtain rights to required third-party
intellectual property rights or maintain the existing intellectual
property rights we have on reasonable terms or at all, we may have
to abandon development of the relevant program or current or future
product and our business, financial condition, results of
operations, cash flows and prospects could suffer.
Changes to the patent law in the United States and other
jurisdictions could increase the uncertainties and costs
surrounding the prosecution of our patent applications and the
enforcement or defense of our issued patents, thereby impairing our
ability to protect our technologies and current or future
products.
As is the case with other life sciences companies, our success is
heavily dependent on intellectual property, particularly patents.
Obtaining and enforcing patents in the life sciences industry
involves both technological and legal complexity and is therefore
costly, time consuming and inherently uncertain. Changes in either
the patent laws or in interpretations of patent laws in the United
States and other countries may increase the uncertainties and costs
surrounding the prosecution of patent applications and the
enforcement or defense of issued patents.
For example, the Leahy-Smith America Invents Act (the “America
Invents Act”), was signed into law on September 16, 2011, and many
of the substantive changes became effective on March 16, 2013. The
America Invents Act and its implementation could increase the
uncertainties and costs surrounding the prosecution of our patent
applications and the enforcement or defense of our issued patents,
all of which could have a material adverse effect on our business,
financial condition, results of operations, and prospects.
Specifically, the America Invents Act reforms United States patent
law in part by changing the U.S. patent system from a “first to
invent” system to a “first inventor to file” system. Under a “first
inventor to file” system, assuming the other requirements for
patentability are met, the first inventor to file a patent
application generally will be entitled to the patent on an
invention regardless of whether another inventor was the first to
invent the invention. This will require us to be cognizant going
forward of the time from invention to filing of a patent
application and be diligent in filing patent applications.
Circumstances may arise that could prevent us from promptly filing
patent applications on our inventions and allow third parties to
file patents claiming our inventions before we are able to do so.
The America Invents Act also includes a number of significant
changes that affect the way patent applications will be prosecuted
and may also affect patent litigation. These include allowing
third-party submission of prior art to the USPTO during patent
prosecution and additional procedures to attack the validity of a
patent by the USPTO administered post grant proceedings, including
reexamination proceedings,
inter partes
review, post grant review and derivation proceedings. These
adversarial proceedings at the USPTO review patent claims without
the presumption of validity afforded to U.S. patents in lawsuits in
U.S. federal courts, and use a lower burden of proof
than used in litigation in U.S. federal courts. Therefore, it is
generally considered easier for a competitor or third party to have
a U.S. patent invalidated in a USPTO post-grant review or
inter partes
review proceeding than in a litigation in a U.S. federal
court.
In addition, the patent positions of companies in the life sciences
industry are particularly uncertain. Recent U.S. Supreme Court
rulings have narrowed the scope of patent protection available in
certain circumstances and weakened the rights of patent owners in
certain situations. This combination of events has created
uncertainty with respect to the validity and enforceability of
patents, once obtained. Depending on future actions by the U.S.
Congress, the federal courts, and the USPTO, the laws and
regulations governing patents could change in unpredictable ways.
In addition, the complexity and uncertainty of European patent laws
have also increased in recent years. Complying with these laws and
regulations could have a material adverse effect on our existing
patent portfolio and our ability to protect and enforce our
intellectual property in the future.
Obtaining and maintaining our patent protection depends on
compliance with various procedural, documentary, fee payment and
other requirements imposed by governmental patent agencies, and our
patent protection could be reduced or eliminated for noncompliance
with these requirements.
Periodic maintenance fees, renewal fees, annuity fees and various
other governmental fees on patents and patent applications will be
due to be paid to the USPTO and various government patent agencies
outside the United States over the lifetime of our patents and
patent applications and any patent rights we may own or license in
the future. Additionally, the USPTO and various government patent
agencies outside the United States require compliance with a number
of procedural, documentary, fee payment and other similar
provisions during the patent application process. In certain cases,
an inadvertent lapse can be cured by payment of a late fee or by
other means in accordance with rules applicable to the particular
jurisdiction. However, there are situations in which noncompliance
can result in abandonment or lapse of the patent or patent
application, resulting in partial or complete loss of patent rights
in the relevant jurisdiction. If we or our licensors fail to
maintain the patents and patent applications covering or otherwise
protecting our current or future products, it could have a material
adverse effect on our business. In addition, to the extent that we
have responsibility for taking any action related to the
prosecution or maintenance of patents or patent applications
in-licensed from a third party, any failure on our part to maintain
the in-licensed intellectual property could jeopardize our rights
under the relevant license and may have a material adverse effect
on our business, financial condition, results of operations, cash
flows and prospects.
We may be subject to claims by third parties asserting that our
employees, consultants, independent contractors or we have
misappropriated their intellectual property, or claiming ownership
of what we regard as our own intellectual property and proprietary
technology.
Many of our employees were previously employed at universities or
other life science, biotechnology or pharmaceutical companies,
including our competitors or potential competitors. We try to
ensure that our employees do not use the proprietary information or
know-how of others in their work for us. We may, however, be
subject to claims that we or these employees have inadvertently or
otherwise used or disclosed intellectual property, trade secrets or
other proprietary information of any such employee’s former
employer or that patents and applications we have filed to protect
inventions of these individuals, even those related to one or more
of our current or future products, are rightfully owned by their
former or concurrent employer. Litigation may be necessary to
defend against these claims. Even if we are successful in defending
ourselves, such litigation could result in substantial costs to us
or be distracting to our management. If we fail to defend any such
claims, in addition to paying monetary damages, we may lose
valuable intellectual property rights or personnel or we could be
required to obtain a license from such third party to commercialize
our technology or products. Such a license may not be available on
an exclusive basis or on commercially reasonable terms or at
all.
In addition, while we typically require our employees, consultants
and independent contractors who may be involved in the development
of intellectual property to execute agreements assigning such
intellectual property to us, we may be unsuccessful in executing
such an agreement with each party who in fact develops intellectual
property that we regard as our own, or such agreements may be
breached or alleged to be ineffective, and the assignment may not
be self-executing, which may result in claims by or against us
related to the ownership of such intellectual property or may
result in such intellectual property becoming assigned to third
parties. If we fail in enforcing or defending any such claims, in
addition to paying monetary damages, we may lose valuable
intellectual property rights. Even if we are successful in
prosecuting or defending against such claims, litigation could
result in substantial costs and be a distraction to our senior
management and scientific personnel. Any of the foregoing could
have a material adverse effect on our business, financial
condition, results of operations, cash flows and
prospects.
We may not be able to protect our intellectual property and
proprietary rights throughout the world.
Filing, prosecuting, and defending patents on current or future
products in all countries throughout the world would be
prohibitively expensive, and the laws of foreign countries may not
protect our rights to the same extent as the laws of
the
United States. Consequently, we may not be able to prevent third
parties from practicing our inventions in all countries outside the
United States, or from selling or importing products made using our
inventions in and into the United States or other jurisdictions.
Third parties may use our technologies in jurisdictions where we
have not obtained or are unable to adequately enforce patent
protection to develop their own products and, further, may export
otherwise infringing products to territories where we have patent
protection but enforcement is not as strong as that in the United
States. These products may compete with our products, and our
patents or other intellectual property rights may not be effective
or sufficient to prevent them from competing.
Many companies have encountered significant problems in protecting
and defending intellectual property rights in foreign
jurisdictions. The legal systems of certain countries, particularly
certain developing countries, do not favor the enforcement of
patents, trade secrets, and other intellectual property protection,
particularly those relating to biotechnology products, which could
make it difficult for us to stop the infringement of our patents or
marketing of competing products in violation of our intellectual
property and proprietary rights generally. Proceedings to enforce
our intellectual property and proprietary rights in foreign
jurisdictions could result in substantial costs and divert our
efforts and attention from other aspects of our business, could put
our patents at risk of being invalidated or interpreted narrowly,
could put our patent applications at risk of not issuing, and could
provoke third parties to assert claims against us. We may not
prevail in any lawsuits that we initiate, and the damages or other
remedies awarded, if any, may not be commercially meaningful.
Accordingly, our efforts to enforce our intellectual property and
proprietary rights around the world may be inadequate to obtain a
significant commercial advantage from the intellectual property
that we develop or license.
Many countries have compulsory licensing laws under which a patent
owner may be compelled to grant licenses to third parties. In
addition, many countries limit the enforceability of patents
against government agencies or government contractors. In these
countries, the patent owner may have limited remedies, which could
materially diminish the value of such patent. If we or any of our
licensors is forced to grant a license to third parties with
respect to any patents relevant to our business, our competitive
position may be impaired, and our business, financial condition,
results of operations, cash flows and prospects may be adversely
affected.
We rely on confidentiality agreements that, if breached, may be
difficult to enforce and could have a material adverse effect on
our business and competitive position.
Our policy is to enter agreements relating to the non-disclosure
and non-use of confidential information with third parties,
including our contractors, consultants, advisors and research
collaborators, as well as agreements that purport to require the
disclosure and assignment to us of the rights to the ideas,
developments, discoveries and inventions of our employees and
consultants while we employ them. However, these agreements can be
difficult and costly to enforce. Moreover, to the extent that our
contractors, consultants, advisors and research collaborators apply
or independently develop intellectual property in connection with
any of our projects, disputes may arise as to the proprietary
rights to the intellectual property. If a dispute arises, a court
may determine that the right belongs to a third party, and
enforcement of our rights can be costly and unpredictable. In
addition, we rely on trade secrets and proprietary know-how that we
seek to protect in part by confidentiality agreements with our
employees, contractors, consultants, advisors or others. Despite
the protective measures we employ, we still face the risk
that:
•these
agreements may be breached;
•these
agreements may not provide adequate remedies for the applicable
type of breach; or
•our
trade secrets or proprietary know-how will otherwise become
known.
Any breach of our confidentiality agreements or our failure to
effectively enforce such agreements would have a material adverse
effect on our business and competitive position.
If our trademarks and trade names are not adequately protected, we
may not be able to build name recognition in our markets of
interest and our business, financial condition, results of
operations, cash flows and prospects may be adversely
affected.
Our trademarks or trade names may be challenged, infringed,
circumvented or declared generic or determined to be infringing on
other marks. We may not be able to protect our rights to these
trademarks and trade names or may be forced to stop using these
names or marks which we need for name recognition by potential
partners or customers in our markets of interest. During trademark
registration proceedings, we may receive rejections. Although we
would be given an opportunity to respond to those rejections, we
may be unable to overcome such rejections. In addition, in the
USPTO and in comparable agencies in many foreign jurisdictions,
third parties are given an opportunity to oppose pending trademark
applications and to seek to cancel registered trademarks.
Opposition or cancellation proceedings may be filed against our
trademarks, and our trademarks may not survive such proceedings. If
we are unable to establish name recognition based on our trademarks
and trade names, we may not
be able to compete effectively and our business, financial
condition, results of operations, cash flows and prospects may be
adversely affected.
Intellectual property rights do not necessarily address all
potential threats.
The degree of future protection afforded by our proprietary and
intellectual property rights is uncertain because such rights offer
only limited protection and may not adequately protect our rights
or permit us to gain or keep our competitive advantage. For
example:
•others
may be able to develop products that are similar to, or better
than, our current or future products in a way that is not covered
by the claims of the patents we license or may own currently or in
the future;
•we,
or our licensing partners or current or future collaborators, might
not have been the first to make the inventions covered by issued
patents or pending patent applications that we license or may own
currently or in the future;
•we,
or our licensing partners or current or future collaborators, might
not have been the first to file patent applications for certain of
our or their inventions;
•our
pending owned or in-licensed patent applications may not lead to
issued patents;
•we
may choose not to file a patent for certain trade secrets or
know-how, and a third party may subsequently file a patent covering
such intellectual property;
•our
competitors or other third parties might conduct research and
development activities in countries where we do not have patent
rights and then use the information learned from such activities to
develop competitive products for sale in our major commercial
markets;
•it
is possible that there are prior public disclosures that could
invalidate our or our licensors’ patents;
•the
patents of third parties or pending or future applications of third
parties, if issued, may have an adverse effect on our
business;
•any
patents that we obtain may not provide us with any competitive
advantages or may ultimately be found not to be owned by us,
invalid or unenforceable; or
•we
may not develop additional proprietary technologies that are
patentable.
Should any of these events occur, they could significantly harm our
business, financial conditions, results of operations, cash flows
and prospects.
Risks Related to Our Indebtedness
Our existing level of indebtedness may increase and adversely
affect our business and growth prospects, growth prospects, and
financial condition, as well as our ability to raise additional
capital on favorable terms, which could, in turn, limit our ability
to develop or acquire new products, services, technologies and
methodologies.
As of December 31, 2022, we had total current and long-term
indebtedness outstanding of approximately $527.4 million, including
term loans of $538.6 million, and unamortized debt issuance costs
of $11.1 million. We may incur significant additional indebtedness
in the future. If we increase our current indebtedness levels, the
risks related to our indebtedness as set forth herein could
intensify.
Our indebtedness, or any additional indebtedness we may incur,
could require us to divert funds identified for other purposes for
debt service and impair our liquidity position. If we cannot
generate sufficient cash flow from operations to service our debt,
we may need to refinance our debt, dispose of assets or issue
equity to obtain necessary funds. We do not know whether we will be
able to take any of these actions on a timely basis, on terms
satisfactory to us or at all.
Our indebtedness, the cash flow needed to satisfy our debt and the
covenants contained in the Credit Agreement have important
consequences, including:
•limiting
funds otherwise available for financing our capital expenditures by
requiring us to dedicate a portion of our cash flows from
operations to the repayment of debt and the interest on this
debt;
•limiting
our ability to incur or prepay existing indebtedness, pay dividends
or distributions, dispose of assets, engage in mergers and
consolidations, make acquisitions or other investments and make
changes in the nature of the business, among other
things;
•making
us more vulnerable to rising interest rates, as certain of our
borrowings, including borrowings under the Credit Agreement, bear
variable rates of interest; and
•making
us more vulnerable in the event of a downturn in our
business.
Our level of indebtedness may place us at a competitive
disadvantage to our competitors that are not as highly leveraged.
Fluctuations in interest rates can increase borrowing costs.
Increases in interest rates may directly impact the amount of
interest we are required to pay and reduce earnings accordingly. In
addition, tax laws, including the disallowance or deferral of tax
deductions for interest paid on outstanding indebtedness, could
have an adverse effect on our liquidity and our business, financial
condition, results of operations, cash flows and prospects.
Further, our Credit Agreement contains customary affirmative and
negative covenants and certain restrictions on operations that
could impose operating and financial limitations and restrictions
on us, including restrictions on our ability to enter into
particular transactions and to engage in other actions that we may
believe are advisable or necessary for our business.
Variable rate indebtedness that we have incurred or may in the
future incur will subject us to interest rate risk, which could
cause our debt service obligations to increase
significantly.
Certain borrowings under our Credit Agreement bear variable rates
of interest. Increase in interest rates directly increase the
amount of interest we are required to pay, and negatively impacts
our net income and cash flows, including cash available for
servicing our indebtedness more generally.
We may not be able to generate sufficient cash flow to service all
of our indebtedness and may be forced to take other actions to
satisfy our debt service obligations, which actions may not be
adequate or may impose additional restrictions on us.
Our ability to make scheduled debt service payments or to refinance
outstanding debt obligations depends on our financial and operating
performance, which is subject to prevailing economic, industry and
competitive conditions and certain financial, business, economic
and other factors beyond our control, including those discussed
under “Risk Related to Our Business and Strategy” above. We may not
be able to maintain a sufficient level of cash flow from operating
activities to permit us to pay the principal, premium, if any, and
interest on our indebtedness. If we cannot meet our debt service
obligations, the holders of our indebtedness would have the right
to accelerate such indebtedness and, to the extent such
indebtedness is secured, foreclose on our assets. This could have
serious consequences to our business, financial condition and
results of operations and could cause us to become bankrupt or
insolvent.
Even if this does not occur, any failure to make payments of
interest and principal on our outstanding indebtedness on a timely
basis would likely result in a reduction of our creditworthiness,
which would also harm our ability to incur additional
indebtedness.
If our cash flows and other capital resources are insufficient to
fund our debt service obligations, we may be forced to reduce or
delay capital expenditures and acquisitions, sell assets, raise
additional capital or seek to restructure or refinance our
indebtedness. If we issue additional equity to repay all or a
portion of our indebtedness, our shareholders may experience
significant dilution of their equity interests. Any refinancing of
our indebtedness could be at higher interest rates and may require
us to comply with more onerous covenants, including the requirement
to maintain specified liquidity or other ratios or restrictions on
our ability to pay dividends or make acquisitions. If these
alternative measures are not successful, we may be required to sell
material assets or operations to attempt to meet our debt service
obligations. Further, we may not be able to consummate these asset
sales (including as a result of restrictions imposed on us under
the Credit Agreement) or sell assets at prices and on terms that we
believe are fair, and any proceeds that we do receive may not be
adequate to meet any debt service obligations then
due.
The terms of the financing documents governing our Credit Agreement
restrict our current and future operations, particularly our
ability to respond to changes or to take certain
actions.
The financing documents governing our Credit Agreement contain a
number of restrictive covenants that impose significant operating
and financial restrictions on us and may limit our ability to
engage in acts that may be in our long-term best interests,
including restrictions on our ability to:
•incur
additional indebtedness;
•incur
liens;
•merge,
dissolve, liquidate, amalgamate, consolidate or sell all or
substantially all of our assets;
•declare
or pay certain dividends, payments or distribution or repurchase or
redeem certain capital stock;
•permit
our subsidiaries to enter into agreements restricting their ability
to pay dividends, make loans, incur liens and sell assets;
and
•make
certain investments.
These restrictions could limit, potentially significantly, our
operational flexibility and affect our ability to finance our
future operations or capital needs or to execute our business
strategy.
Risks Related to Our Organizational Structure
Our principal asset is our interest in Maravai Topco Holdings LLC
(“Topco LLC”), and, accordingly, we depend on distributions from
Topco LLC to pay our taxes and expenses, including payments under
the Tax Receivable Agreement. Topco LLC’s ability to make such
distributions may be subject to various limitations and
restrictions.
We are a holding company and have no material assets other than our
ownership of equity interests in Topco LLC. As such, we have no
independent means of generating revenue or cash flow, and our
ability to pay our taxes, satisfy our obligations under the Tax
Receivable Agreement and pay operating expenses or declare and pay
dividends, if any, in the future depends on the financial results
and cash flows of Topco LLC and its subsidiaries and distributions
we receive from Topco LLC. There can be no assurance that Topco LLC
and its subsidiaries will generate sufficient cash flow to
distribute funds to us or that applicable state law and contractual
restrictions, including negative covenants in debt instruments of
Topco LLC and its subsidiaries, will permit such
distributions.
Topco LLC is treated as a partnership for U.S. federal income tax
purposes and, as such, is not subject to any entity-level U.S.
federal income tax. For U.S. federal income tax purposes, taxable
income of Topco LLC is allocated to the LLC Unitholders of Topco
LLC, including us. Accordingly, we incur income taxes on our
distributive share of any net taxable income of Topco LLC. Under
the terms of the Topco LLC operating agreement (the “LLC Operating
Agreement”), Topco LLC is obligated to make tax distributions to
LLC Unitholders, including us. In addition to tax and dividend
payments, we also incur expenses related to our operations,
including obligations to make payments under the Tax Receivable
Agreement. Due to the uncertainty of various factors, we cannot
estimate the likely tax benefits we may realize as a result of our
purchase of LLC Units in Topco LLC (the “LLC Units”) and LLC Unit
exchanges, and the resulting amounts we are likely to pay out to
LLC Unitholders pursuant to the Tax Receivable Agreement; however,
we estimate that such payments may be substantial. Under the LLC
Operating Agreement, tax distributions shall be made on a pro rata
basis among the LLC Unitholders, and will be calculated without
regard to any applicable basis adjustment under Section 743(b) of
The Internal Revenue Code (“the Code”).
We expect Topco LLC will continue to make cash distributions to the
owners of LLC Units in amounts sufficient to (1) fund all or part
of their tax obligations in respect of taxable income allocated to
them and (2) cover our operating expenses, including payments under
the Tax Receivable Agreement.
However, Topco LLC’s ability to make such distributions may be
subject to various limitations and restrictions, such as
restrictions on distributions that would violate either any
contract or agreement to which Topco LLC or its subsidiaries is
then a party, including debt agreements, or any applicable law, or
that would have the effect of rendering Topco LLC or its
subsidiaries insolvent. In addition, effective for taxable years
beginning after December 31, 2017, liability for adjustments to a
partnership’s tax return may be imputed on the partnership itself
in certain circumstances, absent an election to the contrary. Topco
LLC may be subject to material liabilities pursuant to this
legislation and related guidance if, for example, its calculations
of taxable income are incorrect. If we do not have sufficient funds
to pay tax or other liabilities or to fund our operations, we may
have to borrow funds, which could materially adversely affect our
liquidity and financial condition and subject us to various
restrictions imposed by any such lenders. To the extent that we are
unable to make payments under the Tax Receivable Agreement, such
payments generally will be deferred and will accrue interest until
paid. Nonpayment for a specified period, however, may constitute a
breach of a material obligation under the Tax Receivable Agreement
and therefore accelerate payments due under the Tax Receivable
Agreement, unless, generally, such nonpayment is due to a lack of
sufficient funds.
Payments under the Tax Receivable Agreement will be based on the
tax reporting positions we determine. Although we are not aware of
any issue that would cause the IRS to challenge existing tax basis,
a tax basis increase or other tax attributes subject to the Tax
Receivable Agreement, if any subsequent disallowance of tax basis
or other benefits were so determined by the IRS, we would not be
reimbursed for any payments previously made under the applicable
Tax Receivable Agreement (although we would reduce future amounts
otherwise payable under such Tax Receivable Agreement). In
addition, the actual state or local tax savings we realize may be
different than the amount of such tax savings we are deemed to
realize under the Tax Receivable Agreement, which will be based on
an assumed combined state and local tax rate applied to our
reduction in taxable income as determined for U.S. federal income
tax purposes as a result of the tax attributes subject to the Tax
Receivable Agreement. As a
result, payments could be made under the Tax Receivable Agreement
in excess of the tax savings we realize in respect of the
attributes to which the Tax Receivable Agreement
relate.
Conflicts of interest could arise between our shareholders and
Maravai Life Sciences Holdings, LLC (“MLSH 1”), which may impede
business decisions that could benefit our
shareholders.
MLSH 1, which is controlled by GTCR, LLC (“GTCR”) and is the only
holder of LLC Units other than us, has the right to consent to
certain amendments to the LLC Operating Agreement, as well as to
certain other matters. MLSH 1 may exercise these voting rights in a
manner that conflicts with the interests of our shareholders.
Circumstances may arise in the future when the interests of MLSH 1
conflict with the interests of our shareholders. As we control
Topco LLC, we have certain obligations to MLSH 1 as an LLC
Unitholder in Topco LLC that may conflict with fiduciary duties our
officers and directors owe to our shareholders. These conflicts may
result in decisions that are not in the best interests of
shareholders.
The Tax Receivable Agreement requires us to make cash payments to
MLSH 1 and MLSH 2 in respect of certain tax benefits to which we
may become entitled, and we expect that the payments we will be
required to make will be substantial.
Pursuant to the Tax Receivable Agreement we are required to make
cash payments to MLSH 1 and MLSH 2, collectively, equal to 85% of
the tax benefits, if any, that we actually realize, or, in some
circumstances, are deemed to realize, as a result of (i) certain
increases in the tax basis of assets of Topco LLC and its
subsidiaries resulting from purchases or exchanges of LLC Units,
(ii) certain tax attributes related to the LLC Units held by the
corporations that merged into our corporate structure as part of
the Organizational Transactions (as discussed in Note 10 to our
consolidated financial statements), Topco LLC and subsidiaries of
Topco LLC that existed prior to our initial public offering and
(iii) certain other tax benefits related to our entering into the
Tax Receivable Agreement, including tax benefits attributable to
payments that we make under the Tax Receivable Agreement. Any
payments made by us to MLSH 1 and MLSH 2 under the Tax Receivable
Agreement will generally reduce the amount of overall cash flow
that might have otherwise been available to us. To the extent that
we are unable to make payments under the Tax Receivable Agreement,
such payments generally will be deferred and will accrue interest
until paid. Nonpayment for a specified period, however, may
constitute a breach of a material obligation under the Tax
Receivable Agreement and therefore accelerate payments due under
the Tax Receivable Agreement, unless, generally, such nonpayment is
due to a lack of sufficient funds. Furthermore, our future
obligation to make payments under the Tax Receivable Agreement
could make us a less attractive target for an acquisition,
particularly in the case of an acquirer that cannot use some or all
of the tax benefits that may be deemed realized under the Tax
Receivable Agreement. The payments under the Tax Receivable
Agreement are also not conditioned upon MLSH 1 maintaining a
continued ownership interest in Topco LLC.
The actual amount and timing of any payments under the Tax
Receivable Agreement will vary depending upon a number of factors,
including the timing of exchanges by MLSH 1, the amount of gain
recognized by MLSH 1, the amount and timing of the taxable income
we generate in the future and the federal tax rates then
applicable.
We expect that the aggregate payments that we may make under the
Tax Receivable Agreement will be substantial. Assuming no material
changes in the relevant tax law, and that we earn sufficient
taxable income to realize all tax benefits that are subject to the
Tax Receivable Agreement, we expect that future payments under the
Tax Receivable Agreement relating to the purchase by Maravai
LifeSciences Holdings, Inc. of LLC Units from MLSH 1 to be
approximately $718.2 million and to range from approximately $42.3
million to $63.3 million per year over the next 14 years and
decline thereafter. As a result, we expect that aggregate payments
under the Tax Receivable Agreement over this 14-year period will be
approximately $681.7 million. Future payments in respect of
subsequent exchanges or financing would be in addition to these
amounts and are expected to be substantial. The foregoing numbers
are merely estimates—the actual payments could differ materially.
It is possible that future transactions or events could increase or
decrease the actual tax benefits realized and the corresponding Tax
Receivable Agreement payments. There may be a material negative
effect on our liquidity if, as a result of timing discrepancies or
otherwise, the payments under the Tax Receivable Agreement exceed
the actual benefits we realize in respect of the tax attributes
subject to the Tax Receivable Agreement and/or distributions to
Maravai LifeSciences Holdings, Inc. by Topco LLC are not sufficient
to permit Maravai LifeSciences Holdings, Inc. to make payments
under the Tax Receivable Agreement after it has paid
taxes.
Payments under the Tax Receivable Agreement will be based on the
tax reporting positions that we determine. Although we are not
aware of any issue that would cause the Internal Revenue Service
(“IRS”) to challenge a tax basis increase or the availability of
tax attributes of the corporations merged into our corporate
structure as part of the Organizational Transactions, if any, we
will not be reimbursed for any cash payments previously made to
MLSH 1 and MLSH 2 pursuant to the Tax Receivable Agreement if any
tax benefits initially claimed by us are subsequently disallowed,
in whole or in part, by the IRS or other applicable taxing
authority. For example, if the IRS later asserts that we did not
obtain a tax basis increase or disallows (in whole or in part) the
availability of Net Operating Losses (“NOLs”) due to a potential
ownership change under Section 382 of the Internal Revenue Code
(“IRC” or “the Code”), among other potential challenges, then we
would not be reimbursed for any cash payments previously made to
MLSH 1 and MLSH 2 pursuant to the Tax Receivable Agreement with
respect to such tax
benefits that we had initially claimed. Instead, any excess cash
payments made by us pursuant to the Tax Receivable Agreement will
be netted against any future cash payments that we might otherwise
be required to make under the terms of the Tax Receivable
Agreement. Nevertheless, any tax benefits initially claimed by us
may not be disallowed for a number of years following the initial
time of such payment or, even if challenged early, such excess cash
payment may be greater than the amount of future cash payments that
we might otherwise be required to make under the terms of the Tax
Receivable Agreement. Accordingly, there may not be sufficient
future cash payments against which to net. The applicable U.S.
federal income tax rules are complex, and there can be no assurance
that the IRS or a court will not disagree with our tax reporting
positions. As a result, it is possible that we could make cash
payments under the Tax Receivable Agreement that are substantially
greater than our actual cash tax savings.
Under the Tax Receivable Agreement, we are required to provide MLSH
1 and MLSH 2 with a schedule setting forth the calculation of
payments that are due under the TRA with respect to each taxable
year in which a payment obligation arises within ninety (90) days
after the extended due date of our U.S. federal income tax return
for such taxable year. This calculation will be based upon the
advice of our tax advisors. The calculation will become final
thirty (30) days after it is provided assuming that no objections
are made. Payments under the Tax Receivable Agreement will
generally be made within five (5) business days after this schedule
becomes final pursuant to the procedures set forth in the Tax
Receivable Agreement, although interest on such payments will begin
to accrue at a rate of Intercontinental Exchange London Interbank
Offer Rate (“LIBOR”) for a period of one month (or, if LIBOR ceases
to be published, at a rate selected by us in good faith, with
characteristics similar to LIBOR or consistent with market
practices generally, any such rate, a “Replacement Rate”) plus 100
basis points from the due date (without extensions) of such tax
return. Generally, any late payments that may be made under the Tax
Receivable Agreement will continue to accrue interest at LIBOR (or
a Replacement Rate, as applicable) plus 500 basis points until such
payments are made, including any late payments that we may
subsequently make because we did not have enough available cash to
satisfy our payment obligations at the time at which they
originally arose.
The amounts that we may be required to pay to MLSH 1 and MLSH 2
under the Tax Receivable Agreement may be accelerated in certain
circumstances and may also significantly exceed the actual tax
benefits that we ultimately realize.
The Tax Receivable Agreement provides that if (1) certain mergers,
asset sales, other forms of business combination or other changes
of control were to occur, (2) we breach any of our material
obligations under the Tax Receivable Agreement or (3) at any time,
we elect an early termination of the Tax Receivable Agreement, then
the Tax Receivable Agreement will terminate and our obligations, or
our successor’s obligations, to make payments under the Tax
Receivable Agreement would accelerate and become immediately due
and payable. The amount due and payable in that circumstance is
based on certain assumptions, including an assumption that we would
have sufficient taxable income to fully utilize all potential
future tax benefits that are subject to the Tax Receivable
Agreement. We may need to incur debt to finance payments under the
Tax Receivable Agreement to the extent our cash resources are
insufficient to meet our obligations under the Tax Receivable
Agreement as a result of timing discrepancies or
otherwise.
As a result of a change in control, material breach or our election
to terminate the Tax Receivable Agreement early, (1) we could be
required to make cash payments to MLSH 1 and MLSH 2 that are
greater than the specified percentage of the actual benefits we
ultimately realize in respect of the tax benefits that are subject
to the Tax Receivable Agreement and (2) we would be required to
make an immediate cash payment equal to the anticipated future tax
benefits that are the subject of the Tax Receivable Agreement
discounted in accordance with the Tax Receivable Agreement, which
payment may be made significantly in advance of the actual
realization, if any, of such future tax benefits. In these
situations, our obligations under the Tax Receivable Agreement
could have a substantial negative impact on our liquidity and could
have the effect of delaying, deferring or preventing certain
mergers, asset sales, other forms of business combination, or other
changes of control. There can be no assurance that we will be able
to finance our obligations under the Tax Receivable
Agreement.
Our organizational structure, including the Tax Receivable
Agreement, confers certain benefits upon MLSH 1 and MLSH 2 that
will not benefit the other common shareholders to the same extent
as they will benefit MLSH 1 and MLSH 2.
Our organizational structure, including the Tax Receivable
Agreement, confers certain benefits upon MLSH 1, as the only other
LLC Unitholder in Topco LLC, and MLSH 2 that will not benefit the
other holders of our Class A common stock to the same extent. We
have entered into a Tax Receivable Agreement with MLSH 1 and MLSH
2, which will provide for the payment by us to MLSH 1 and MLSH 2,
collectively, of 85% of the amount of tax benefits, if any, that we
actually realize, or in some circumstances are deemed to realize,
as a result of (i) certain increases in the tax basis of assets of
Topco LLC and its subsidiaries resulting from purchases or
exchanges of LLC Units, (ii) certain tax attributes of certain of
the entities (the “Blocker Entities”) through which GTCR and other
existing members of MLSH 1 and MLSH 2 held their ownership
interests in MLSH 1, Topco LLC and subsidiaries of Topco LLC that
existed prior to our initial public offering and (iii) certain
other tax benefits related to our entering into the Tax Receivable
Agreement, including tax benefits attributable to payments that we
make under the Tax Receivable Agreement. Due to the uncertainty of
various factors, we cannot estimate the likely tax
benefits
we will realize as a result of purchases of LLC Units and LLC Unit
exchanges, and the resulting amounts we are likely to pay out to
MLSH 1 and MLSH 2 pursuant to the Tax Receivable Agreement;
however, we estimate that such payments may be substantial.
Although we will retain 15% of the amount of such tax benefits,
this and other aspects of our organizational structure may
adversely impact the future trading market for the Class A common
stock.
We may not be able to realize all or a portion of the tax benefits
that are currently expected to result from the tax attributes
covered by the Tax Receivable Agreement and from payments made
under the Tax Receivable Agreement.
Our ability to realize the tax benefits that we currently expect to
be available as a result of the attributes covered by the Tax
Receivable Agreement, the payments made pursuant to the Tax
Receivable Agreement, and the interest deductions imputed under the
Tax Receivable Agreement all depend on a number of assumptions,
including that we earn sufficient taxable income each year during
the period over which such deductions are available and that there
are no adverse changes in applicable law or regulations.
Additionally, if our actual taxable income were insufficient or
there were additional adverse changes in applicable law or
regulations, we may be unable to realize all or a portion of the
expected tax benefits and our cash flows and shareholders’ equity
could be negatively affected.
In certain circumstances, Topco LLC will be required to make
distributions to us and MLSH 1 and the distributions may be
substantial.
Topco LLC is treated as a partnership for U.S. federal income tax
purposes and, as such, is not subject to U.S. federal income tax.
Instead, taxable income is allocated to its members, including us.
We expect Topco LLC will continue to make tax distributions
quarterly to the LLC Unitholders in Topco LLC (including us), in
each case on a pro rata basis based on Topco LLC’s net taxable
income and without regard to any applicable basis adjustment under
Section 743(b) of the Code. Funds used by Topco LLC to satisfy its
tax distribution obligations will not be available for reinvestment
in our business. Moreover, these tax distributions may be
substantial, and will likely exceed (as a percentage of Topco LLC’s
income) the overall effective tax rate applicable to a similarly
situated corporate taxpayer. As a result, it is possible that we
will receive distributions significantly in excess of our tax
liabilities and obligations to make payments under the Tax
Receivable Agreement. While our Board may choose to distribute such
cash balances as dividends on our Class A common stock, they will
not be required to do so, and may in their sole discretion choose
to use such excess cash for any purpose (including an investment of
such cash into Topco LLC) depending upon the facts and
circumstances at the time of determination. See “Dividend
Policy.”
Unanticipated changes in effective tax rates or adverse outcomes
resulting from examination of our income or other tax returns could
adversely affect our operating results and financial
condition.
We are subject to income taxes in the U.S. and certain foreign
jurisdictions. Our tax liabilities will be subject to the
allocation of expenses in differing jurisdictions. Our future
effective tax rates could be subject to volatility or adversely
affected by a number of factors, including:
•changes
in the valuation of our deferred tax assets and
liabilities;
•expected
timing and amount of the release of any tax valuation
allowances;
•expiration
of, or detrimental changes in, research and development tax credit
laws; or
•changes
in tax laws, regulations or interpretations thereof.
In addition, we may be subject to audits of our income, sales and
other transaction taxes by U.S. federal, state and foreign
authorities. Outcomes from these audits could have an adverse
effect on our operating results and financial
condition.
If we were deemed to be an investment company under the Investment
Company Act of 1940, as amended (the “1940 Act”), applicable
restrictions could make it impractical for us to continue our
business as contemplated and could have a material adverse effect
on our business, financial condition, results of operations, cash
flows and prospects.
Under Sections 3(a)(1)(A) and (C) of the 1940 Act, a company
generally will be deemed to be an “investment company” for purposes
of the 1940 Act if it (1) is, or holds itself out as being, engaged
primarily, or proposes to engage primarily, in the business of
investing, reinvesting or trading in securities or (2) is engaged,
or proposes to engage, in the business of investing, reinvesting,
owning, holding or trading in securities and it owns or proposes to
acquire investment securities having a value exceeding 40% of the
value of its total assets (exclusive of U.S. government securities
and cash items) on an unconsolidated basis. We do not believe that
we are an “investment company,” as such term is defined in either
of those sections of the 1940 Act.
As the sole managing member of Topco LLC, we will control and
manage Topco LLC. On that basis, we believe that our interest in
Topco LLC is not an “investment security” under the 1940 Act.
Therefore, we have less than 40% of the value of our
total assets (exclusive of U.S. government securities and cash
items) in “investment securities.” However, if we were to lose the
right to manage and control Topco LLC, interests in Topco LLC could
be deemed to be “investment securities” under the 1940
Act.
We intend to conduct our operations so that we will not be deemed
to be an investment company. However, if we were deemed to be an
investment company, restrictions imposed by the 1940 Act, including
limitations on our capital structure and our ability to transact
with affiliates, could make it impractical for us to continue our
business as contemplated and could have a material adverse effect
on our business, financial condition, results of operations, cash
flows and prospects.
Risks Related to Being a Public Company
We are obligated to develop and maintain proper and effective
internal control over financial reporting in order to comply with
Section 404 of the Sarbanes-Oxley Act. We may not complete our
analysis of our internal control over financial reporting in a
timely manner, or these internal controls may not be determined to
be operating effectively, which may adversely affect investor
confidence in us and, as a result, the value of our Class A common
stock.
Our management is responsible for establishing and maintaining
adequate internal control over financial reporting. Internal
control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements in accordance
with GAAP. Developing the system and processing documentation
necessary to perform the evaluation needed to comply with Section
404 of the Sarbanes-Oxley Act is a costly and challenging process.
If we are unable to assert that our internal control over financial
reporting is effective, we could lose investor confidence in the
accuracy and completeness of our financial reports, which could
cause the price of our Class A common stock to decline, and we may
be subject to investigation or sanctions by the SEC.
We are required, pursuant to Section 404 of the Sarbanes-Oxley Act,
to furnish a report by management on, among other things, the
effectiveness of our internal control over financial reporting.
This assessment must be made yearly and must include disclosure of
any material weaknesses identified by our management in our
internal control over financial reporting. We also must disclose
changes made in our internal control and procedures on a quarterly
basis. Further, our independent registered public accounting firm
must report on the effectiveness of our internal control over
financial reporting pursuant to Section 404 of the Sarbanes-Oxley
Act. Our independent registered public accounting firm may issue a
report that is adverse in the event it is not satisfied with the
level at which our controls are documented, designed or operating,
which could cause the price of our Class A common stock to decline,
and we may be subject to investigation or sanctions by the
SEC.
Additionally, the existence of any material weakness or significant
deficiency would require management to devote significant time and
incur significant expense to remediate any such material weaknesses
or significant deficiencies and management may not be able to
remediate any such material weaknesses or significant deficiencies
in a timely manner. The existence of any material weakness in our
internal control over financial reporting could also result in
errors in our financial statements that could require us to restate
our financial statements, cause us to fail to meet our reporting
obligations and cause shareholders to lose confidence in our
reported financial information, all of which could materially and
adversely affect our business and stock price.
Risks Related to Our Class A Common Stock
GTCR controls us, and its interests may conflict with ours or yours
in the future.
As of December 31, 2022, investment entities affiliated with
GTCR collectively controlled approximately 57% of the voting power
of our outstanding common stock and therefore GTCR controls the
vote of all matters submitted to a vote of our shareholders. This
control enables GTCR to control the election of the members of the
Board and all other corporate decisions. Even when GTCR ceases to
control a majority of the total voting power, for so long as GTCR
continues to own a significant percentage of our Class A common
stock, GTCR will still be able to significantly influence the
composition of our Board and the approval of actions requiring
shareholder approval. Accordingly, for such period of time, GTCR
will have significant influence with respect to our management,
business plans and policies, including the appointment and removal
of our officers, decisions on whether to raise future capital and
amending our charter and bylaws, which govern the rights attached
to our Class A common stock. In particular, for so long as GTCR
continues to own a significant percentage of our Class A common
stock, GTCR will be able to cause or prevent a change of control of
us or a change in the composition of our Board and could preclude
any unsolicited acquisition of us. The concentration of ownership
could deprive you of an opportunity to receive a premium for your
shares of Class A common stock as part of a sale of us and
ultimately might affect the market price of our Class A common
stock.
We entered into a Director Nomination Agreement with GTCR that
provides GTCR the right to nominate to the Board a number of
designees equal to at least: (i) 100% of the total number of
directors comprising the Board, so long as GTCR beneficially owns
shares of Class A common stock and Class B common stock
representing at least 40% of the total amount of shares of Class A
common stock and Class B common stock it beneficially owned as of
November 19, 2020, (ii) 40% of the total number of directors, in
the event that GTCR beneficially owns shares of Class A common
stock and Class B common stock representing at least 30% but less
than 40% of the total amount of shares of Class A common stock and
Class B common stock it owned as of November 19, 2020, (iii) 30% of
the total number of directors, in the event that GTCR beneficially
owns shares of Class A common stock and Class B common stock
representing at least 20% but less than 30% of the total amount of
shares of Class A common stock and Class B common stock it owned as
of November 19, 2020, (iv) 20% of the total number of directors, in
the event that GTCR beneficially owns shares of Class A common
stock and Class B common stock representing at least 10% but less
than 20% of the total amount of shares of Class A common stock and
Class B common stock it owns as of November 19, 2020 and (v) one
director, in the event that GTCR beneficially owns shares of Class
A common stock and Class B common stock representing at least 5% of
the total amount of shares of Class A common stock and Class B
common stock it owned as of November 19, 2020. The Director
Nomination Agreement provides that GTCR may assign such right to a
GTCR affiliate. The Director Nomination Agreement prohibits us from
increasing or decreasing the size of our Board without the prior
written consent of GTCR.
GTCR and its affiliates engage in a broad spectrum of activities,
including investments in our industry generally. In the ordinary
course of their business activities, GTCR and its affiliates may
engage in activities where their interests conflict with our
interests or those of our other shareholders, such as investing in
or advising businesses that directly or indirectly compete with
certain portions of our business or are suppliers or customers of
ours. Our certificate of incorporation provides that none of GTCR,
any of its affiliates or any director who is not employed by us
(including any non-employee director who serves as one of our
officers in both his or her director and officer capacities) or its
affiliates has any duty to refrain from engaging, directly or
indirectly, in the same business activities or similar business
activities or lines of business in which we operate. GTCR also may
pursue acquisition opportunities that may be complementary to our
business, and, as a result, those acquisition opportunities may not
be available to us. In addition, GTCR may have an interest in
pursuing acquisitions, divestitures and other transactions that, in
its judgment, could enhance its investment, even though such
transactions might involve risks to you or may not prove
beneficial.
We are a “controlled company” within the meaning of the rules of
NASDAQ and, as a result, we qualify for and rely on exemptions from
certain corporate governance requirements. You will not have the
same protections as those afforded to shareholders of companies
that are subject to such governance requirements.
GTCR controls a majority of the voting power of our outstanding
common stock. As a result, we are a “controlled company” within the
meaning of the corporate governance standards of NASDAQ. Under
these rules, a company of which more than 50% of the voting power
for the election of directors is held by an individual, group or
another company is a “controlled company” and may elect not to
comply with certain corporate governance requirements,
including:
•the
requirement that a majority of our Board consist of independent
directors;
•the
requirement that we have a nominating and corporate governance
committee that is composed entirely of independent directors with a
written charter addressing the committee’s purpose and
responsibilities;
•the
requirement that we have a compensation committee that is composed
entirely of independent directors with a written charter addressing
the committee’s purpose and responsibilities; and
•the
requirement for an annual performance evaluation of the nominating
and corporate governance and compensation committees.
We utilize these exceptions and do not have a majority of
independent directors on our Board, our compensation and nominating
committee does not consist entirely of independent directors and is
not subject to annual performance evaluations, and we do not have a
corporate governance committee. Accordingly, you will not have the
same protections afforded to shareholders of companies that are
subject to all of the corporate governance requirements of
NASDAQ.
Provisions of our corporate governance documents could make an
acquisition of us more difficult and may prevent attempts by our
shareholders to replace or remove our current management, even if
beneficial to our shareholders.
Our certificate of incorporation and bylaws and the Delaware
General Corporation Law (the “DGCL”) contain provisions that could
make it more difficult for a third party to acquire us, even if
doing so might be beneficial to our shareholders. Among other
things:
•these
provisions allow us to authorize the issuance of undesignated
preferred stock, the terms of which may be established and the
shares of which may be issued without shareholder approval, and
which may include supermajority voting, special approval, dividend,
or other rights or preferences superior to the rights of
shareholders;
•these
provisions provide for a classified board of directors with
staggered three-year terms;
•these
provisions provide that, at any time when GTCR controls, in the
aggregate, less than 40% of the outstanding shares of our Class A
common stock, directors may only be removed for cause, and only by
the affirmative vote of holders of at least 66 2⁄3% in voting power
of all the then-outstanding shares of our stock entitled to vote
thereon, voting together as a single class;
•these
provisions prohibit shareholder action by written consent from and
after the date on which GTCR controls, in the aggregate, less than
35% in voting power of our stock entitled to vote generally in the
election of directors;
•these
provisions provide that for as long as GTCR controls, in the
aggregate, at least 50% in voting power of our stock entitled to
vote generally in the election of directors, any amendment,
alteration, rescission or repeal of our bylaws by our shareholders
will require the affirmative vote of a majority in voting power of
the outstanding shares of our capital stock and at any time when
GTCR controls, in the aggregate, less than 50% in voting power of
all outstanding shares of our stock entitled to vote generally in
the election of directors, any amendment, alteration, rescission or
repeal of our bylaws by our shareholders will require the
affirmative vote of the holders of at least 66 2⁄3% in voting power
of all the then-outstanding shares of our stock entitled to vote
thereon, voting together as a single class; and
•these
provisions establish advance notice requirements for nominations
for elections to our Board or for proposing matters that can be
acted upon by shareholders at shareholder meetings; provided,
however, at any time when GTCR controls, in the aggregate, at least
10% in voting power of our stock entitled to vote generally in the
election of directors, such advance notice procedure will not apply
to GTCR.
We opted out of Section 203 of the DGCL, which generally prohibits
a Delaware corporation from engaging in any of a broad range of
business combinations with any interested shareholder for a period
of three years following the date on which the shareholder became
an interested shareholder. However, our certificate of
incorporation contains a provision that provides us with
protections similar to Section 203, and prevents us from engaging
in a business combination with a person (excluding GTCR and any of
its direct or indirect transferees and any group as to which such
persons are a party) who acquires at least 85% of our Class A
common stock for a period of three years from the date such person
acquired such common stock, unless board or shareholder approval is
obtained prior to the acquisition. These provisions could
discourage, delay or prevent a transaction involving a change in
control of our company. These provisions could also discourage
proxy contests and make it more difficult for you and other
shareholders to elect directors of your choosing and cause us to
take other corporate actions you desire, including actions that you
may deem advantageous, or negatively affect the trading price of
our Class A common stock. In addition, because our Board is
responsible for appointing the members of our management team,
these provisions could in turn affect any attempt by our
shareholders to replace current members of our management
team.
These and other provisions in our certificate of incorporation,
bylaws and Delaware law could make it more difficult for
shareholders or potential acquirers to obtain control of our Board
or initiate actions that are opposed by our then-current Board,
including actions to delay or impede a merger, tender offer or
proxy contest involving our company. The existence of these
provisions could negatively affect the price of our Class A common
stock and limit opportunities for you to realize value in a
corporate transaction.
Our certificate of incorporation designates the Court of Chancery
of the State of Delaware as the exclusive forum for certain
litigation that may be initiated by our shareholders and the
federal district courts of the United States as the exclusive forum
for litigation arising under the Securities Act, which could limit
our shareholders’ ability to obtain a favorable judicial forum for
disputes with us.
Pursuant to our certificate of incorporation, unless we consent in
writing to the selection of an alternative forum, the Court of
Chancery of the State of Delaware is the sole and exclusive forum
for any claims in state court for (1) any derivative action or
proceeding brought on our behalf, (2) any action asserting a claim
of breach of a fiduciary duty owed by any of our directors,
officers or other employees to us or our shareholders, (3) any
action asserting a claim against us arising pursuant to any
provision of the DGCL, our certificate of incorporation or our
bylaws or (4) any other action asserting a claim against us that
is
governed by the internal affairs doctrine; provided that for the
avoidance of doubt, the forum selection provision that identifies
the Court of Chancery of the State of Delaware as the exclusive
forum for certain litigation, including any “derivative action,”
will not apply to suits to enforce a duty or liability created by
the Securities Act, the Exchange Act or any other claim for which
the federal courts have exclusive jurisdiction. Our certificate of
incorporation also provides that, unless we consent in writing to
the selection of an alternative forum, the federal district courts
of the United States shall be the exclusive forum for the
resolution of any complaint asserting a cause of action arising
under the Securities Act. Our certificate of incorporation further
provides that any person or entity purchasing or otherwise
acquiring any interest in shares of our capital stock is deemed to
have notice of and consented to the provisions of our certificate
of incorporation described above. The forum selection provisions in
our certificate of incorporation may have the effect of
discouraging lawsuits against us or our directors and officers and
may limit our shareholders’ ability to obtain a favorable judicial
forum for disputes with us. If the enforceability of our forum
selection provisions were to be challenged, we may incur additional
costs associated with resolving such challenge. While we currently
have no basis to expect any such challenge would be successful, if
a court were to find our forum selection provisions to be
inapplicable or unenforceable with respect to one or more of these
specified types of actions or proceedings, we may incur additional
costs associated with having to litigate in other jurisdictions,
which could have an adverse effect on our business, financial
condition, results of operations, cash flows and prospects and
result in a diversion of the time and resources of our employees,
management and board of directors.
Our operating results and stock price may be volatile.
Our quarterly operating results are likely to fluctuate in the
future. In addition, securities markets worldwide have experienced,
and are likely to continue to experience, significant price and
volume fluctuations, including as a result of the current
macroeconomic environment and fiscal and monetary policy
uncertainty. This market volatility, as well as other general
economic, market or political conditions, could subject the market
price of our Class A common stock to wide price fluctuations
regardless of our operating performance. Our operating results and
the trading price of our Class A common stock may fluctuate in
response to various factors, including those discussed throughout
this section.
A significant portion of our total outstanding shares of Class A
common stock, including newly issued shares of Class A common stock
issued upon the exchange of UP-C interests by MLSH 1, may be sold
into the market in the near future. This could cause the market
price of our Class A common stock to drop significantly, even if
our business is doing well.
Sales of a substantial number of shares of our Class A common stock
in the public market could occur at any time. These sales, or the
perception in the market that the holders of a large number of
shares of Class A common stock intend to sell shares, could reduce
the market price of our Class A common stock. As of
December 31, 2022, we had 131,691,863 outstanding shares of
Class A common stock, 21,681,033 of which are subject to
restrictions imposed by federal securities laws. All of these
shares of Class A common stock could, however, be sold from time to
time, subject to restrictions imposed by federal securities laws.
We also register shares of Class A common stock that we issue under
our equity compensation plans. Once we register these shares, they
can be freely sold in the public market upon issuance. Further, as
of December 31, 2022, an additional 123,669,196 shares of
Class A common stock are issuable upon the exchange by MLSH 1 of
its interest in Topco.
Because we have no current plans to pay regular cash dividends on
our Class A common, you may not receive any return on investment
unless you sell your Class A common stock for a price greater than
that which you paid for it.
We do not anticipate paying any regular cash dividends on our Class
A common stock. Any decision to declare and pay dividends in the
future will be made at the discretion of our Board and will depend
on, among other things, our results of operations, financial
condition, cash requirements, contractual restrictions and other
factors that our Board may deem relevant. In addition, our ability
to pay dividends is, and may be, limited by covenants of existing
and any future outstanding indebtedness we or our subsidiaries
incur. Therefore, any return on investment in our Class A common
stock is solely dependent upon the appreciation of the price of our
Class A common stock on the open market, which may not
occur.
We may issue shares of preferred stock in the future, which could
make it difficult for another company to acquire us or could
otherwise adversely affect holders of our Class A common stock,
which could depress the price of our Class A common
stock.
Our certificate of incorporation authorizes us to issue one or more
series of preferred stock. Our Board has the authority to determine
the preferences, limitations and relative rights of the shares of
preferred stock and to fix the number of shares constituting any
series and the designation of such series, without any further vote
or action by our shareholders. Our preferred stock could be issued
with voting, liquidation, dividend and other rights superior to the
rights of our Class A common stock. The potential issuance of
preferred stock may delay or prevent a change in control of us,
discouraging bids for our Class A common stock at a premium to the
market price, and materially adversely affect the market price and
the voting and other rights of the holders of our Class A common
stock.
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
Our corporate headquarters and certain of our research and
development operations are located in San Diego, California. The
facilities serve as the principal hub of operations for our nucleic
acid production business and were purpose built to expand the
capacity of this business segment while adding specialized
capabilities in the form of clean rooms, air handling, waste and
solvent handling, and GMP capabilities. Our facility leases expire
at varying dates through 2037, not including renewals that are at
our option.
All facilities are leased. A summary of our facilities is listed
below.
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Location |
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Approx. Square Footage |
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Segment |
San Diego, CA |
|
185,000 |
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Nucleic Acid Production |
Sterling, VA |
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21,000 |
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Nucleic Acid Production |
Leland, NC |
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46,000 |
|
Biologics Safety Testing |
Southport, NC |
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20,000 |
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Biologics Safety Testing |
Item 3. Legal Proceedings
From time to time, we may be involved in various legal proceedings
and subject to claims that arise in the ordinary course of
business. Although the results of litigation and claims are
inherently unpredictable and uncertain, we are not currently a
party to any legal proceedings the outcome of which, if determined
adversely to us, are believed to, either individually or taken
together, have a material adverse effect on our business, operating
results, cash flows or financial condition. Regardless of the
outcome, litigation has the potential to have an adverse impact on
us because of defense and settlement costs, diversion of management
resources, and other factors. See Item 1A. “Risk Factors—Risks
Related to Our Intellectual Property—Intellectual property
litigation and other proceedings could cause us to spend
substantial resources and distract our personnel from their normal
responsibilities” and “Risk Factors—Risks Related to Our
Intellectual Property—If we are sued for infringing,
misappropriating, or otherwise violating intellectual property
rights of third parties, such litigation could be costly and time
consuming and could prevent or delay us from developing or
commercializing our current or future products.”
Item 4. Mine Safety Disclosures
None.
Part II.
Item 5. Market for Registrant’s Common Equity, Related Stockholder
Matters and Issuer Purchases of Equity Securities
Market Information
Our Class A common stock trades on The Nasdaq Global Select Market
under the symbol “MRVI.”
Our Class B common stock is not listed nor traded on any stock
exchange.
Stock Performance Graph
The following graph shows the total stockholder’s return on an
investment of $100 in cash at market close on November 20, 2020
(the first day of trading of our common stock), through
December 31, 2022 for (i) our Class A common stock, (ii) the
Nasdaq Composite Index and (iii) the Nasdaq Biotechnology Index.
Pursuant to applicable Securities and Exchange Commission rules,
all values assume reinvestment of pre-tax amount of all dividends;
however, no dividends have been declared on our Class A common
stock to date. The stockholder return shown in the graph below may
not be indicative of future stock price performance, and we do not
make or endorse any predictions as to future stockholder return.
This graph shall not be deemed “soliciting material” or be deemed
“filed” for purposes of Section 18 of the Securities Exchange Act
of 1934 as amended, or Exchange Act, or otherwise subject to the
liabilities under that Section, and shall not be deemed to be
incorporated by reference into any of our filings under the
Securities Act of 1933, as amended, or Securities Act, whether made
before or after the date hereof and irrespective of any general
incorporation language in any such filing.

Holders of Common Stock
As of February 21, 2023, there were two holders of record of
our Class A common stock. This number does not include a greater
number of beneficial holders of our Class A common stock whose
shares are held by clearing houses, banks, brokers and other
financial institutions which are aggregated into a single holder of
record.
As of February 21, 2023, there was one holder of record of our
Class B common stock.
Dividend Policy
We currently intend to retain all available funds and any future
earnings to fund the development and growth of our business and to
repay indebtedness and, therefore, we do not anticipate paying any
cash dividends in the foreseeable future.
Additionally,
because we are a holding company, our ability to pay dividends on
our Class A common stock may be limited by restrictions on the
ability of our subsidiaries to pay dividends or make distributions
to us. Any future determination to pay dividends will be at the
discretion of our Board, subject to compliance with covenants in
current and future agreements governing our and our subsidiaries’
indebtedness, including our Credit Agreement (the “Credit
Agreement”) entered into in October 2020, and will depend on our
results of operations, financial conditions, capital requirements
and other factors that our Board deems relevant.
Equity Compensation Plan Information
The following table sets forth information as of December 31,
2022 regarding shares of our Class A common stock that may be
issued under the Company’s equity compensation plan, consisting of
our 2020 Omnibus Incentive Plan (the “2020 Plan) and our 2020
Employee Stock Purchase Plan (the “ESPP”).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plan Category |
|
Number of securities to be issued upon exercise of outstanding
options, warrants and rights (a) |
|
Weighted-average exercise price of outstanding options, warrants
and rights |
|
Number of securities available for future issuance under equity
compensation plans (excluding securities reflected in column
(a)) |
Equity compensation plans approved by security holders
(1) (2)
|
|
4,464,722 |
|
$ |
17.14 |
|
|
52,446,489 |
Total |
|
4,464,722 |
|
$ |
17.14 |
|
|
52,446,489 |
____________________
(1)Includes
10,740,041 shares that remain available for purchase under the 2020
Employee Stock Purchase Plan and 46,171,170 shares of common stock
that remain available for grant under the 2020 Omnibus Incentive
Plan. The 2020 Omnibus Incentive Plan provides for an automatic
increase in the number of shares reserved for issuance thereunder
on January 1 of each calendar year during the term of the Plan,
equal to the lesser of (a) 4.0% of the aggregate number of shares
and shares of Class B common stock outstanding on the final day of
the immediately preceding calendar year and (b) such smaller number
of shares as determined by the Board. The 2020 Employee Stock
Purchase Plan also provides for an automatic increase in the number
of shares reserved for issuance thereunder on January 1 of each
calendar year during the term of the plan, equal to the lesser of
(a) 1.25% of the aggregate number of shares and shares of Class B
common stock outstanding on the final day of the immediately
preceding calendar year and (b) such smaller number of shares as is
determined by the Board, provided that the shares reserved under
the ESPP shall not exceed an aggregate of 10,948,877
shares.
(2)The
weighted average exercise price includes restricted stock unit
awards that can be exercised for no consideration. The weighted
average exercise price excluding these restricted stock units is
$26.45.
Item 6. Reserved
Item 7. Management’s Discussion and Analysis of Financial Condition
and Results of Operations
You should read the following discussion and analysis of financial
condition and results of operations together with our audited
consolidated financial statements and related notes included
elsewhere in this Annual Report on Form 10-K. This discussion and
analysis reflects our historical consolidated results of operations
and financial position, and contain forward-looking statements that
involve risks and uncertainties. Our actual results could differ
materially from those discussed in or implied by these
forward-looking statements. Factors that could cause or contribute
to such differences include, but are not limited to, those
discussed in the section titled “Risk Factors.” Please also see the
section titled “Forward Looking Statements.” We were incorporated
in August 2020 and, pursuant to the organizational transactions
described in Note 10 to our consolidated financial statements,
became a holding company whose principal asset is a controlling
equity interest in Topco LLC. As the sole managing member of Topco
LLC, we operate and control the business and affairs of Topco LLC
and its subsidiaries. Accordingly, we consolidate Topco LLC in our
consolidated financial statements and report a non-controlling
interest related to the portion of Topco LLC not owned by us.
Because the organizational transactions were considered
transactions between entities under common control, the
consolidated financial statements for periods prior to the
organizational transactions and the initial public offering have
been adjusted to combine the previously separate entities for
presentation purposes. Unless otherwise noted or the context
otherwise requires, references in this Annual Report on Form 10-K
to “we,” “us” or “our” refer to Maravai LifeSciences Holdings, Inc.
and its subsidiaries.
This discussion and analysis generally addresses 2022 and 2021
items and year-over-year comparisons between 2022 and 2021.
Discussions of 2020 items and year-over-year comparisons between
2021 and 2020 that are not included in this Annual Report on Form
10-K can be found in Part II, Item 7 of our 2021 Annual Report on
Form 10-K filed with the SEC on March 1, 2022.
Overview
We are a leading life sciences company providing critical products
to enable the development of drug therapies, diagnostics, novel
vaccines and support research on human diseases. Our customers
include the top global biopharmaceutical companies ranked by
research and development expenditures according to industry
consultants, and many other emerging biopharmaceutical and life
sciences research companies, as well as leading academic research
institutions and
in vitro
diagnostics companies. Our products address the key phases of
biopharmaceutical development and include complex nucleic acids for
diagnostic and therapeutic applications, antibody-based products to
detect impurities during the production of biopharmaceutical
products, and products to detect the expression of proteins in
tissues of various species.
We have and will continue to build a transformative life sciences
products company by acquiring businesses and accelerating their
growth through capital infusions and industry expertise. Biomedical
innovation is dependent on a reliable supply of reagents in the
fields of nucleic acid production, biologics safety testing and
protein labeling. From inventive startups to the world’s leading
biopharmaceutical, vaccine, diagnostics and gene and cell therapy
companies, these customers turn to us to solve their complex
discovery challenges and help them streamline and scale their
supply chain needs beginning from research and development through
clinical trials to commercialization.
Our primary customers are biopharmaceutical companies who are
pursuing novel research and product development programs. Our
customers also include a range of government, academic and
biotechnology institutions.
As of December 31, 2022, we employed a team of over 610
full-time employees, approximately 18% of whom have advanced
degrees. We primarily utilize a direct sales model for our sales to
our customers in North America. Our international sales, primarily
in Europe and Asia Pacific, are effected through a combination of
third-party distributors as well as via a direct sales model. The
percentage of our total revenue derived from customers in North
America was 38.4% and 39.7% for the years ended December 31,
2022 and 2021, respectively.
We generated revenue of $883.0 million and $799.2 million for the
years ended December 31, 2022 and 2021,
respectively.
Total revenue by segment was $813.1 million in Nucleic Acid
Production and $69.9 million in Biologics Safety Testing for the
year ended December 31, 2022. Total revenue by segment was
$711.9 million in Nucleic Acid Production, $68.4 million in
Biologics Safety Testing and $19.0 million in Protein Detection for
the year ended December 31, 2021. We divested our Protein
Detection segment in September 2021, and since then operate two
business segments only, Nucleic Acid Production and Biologics
Safety Testing.
We focus a substantial portion of our resources supporting our core
business segments. We are actively pursuing opportunities to expand
our customer base both domestically and internationally by
fostering strong relationships with both existing and new customers
and distributors. Our management team has experience working with
biopharmaceutical, vaccine, diagnostics and gene and cell therapy
companies as well as academic and research scientists. We also
intend to continue making investments in our overall infrastructure
and business segments to support our growth. We incurred aggregate
selling, general, and administrative expenses of $129.3 million and
$100.1 million for the years ended December 31, 2022 and 2021
respectively.
Our research and development efforts are geared towards meeting our
customers’ needs. We incurred research and development expenses of
$18.4 million and $15.2 million for the years ended
December 31, 2022 and 2021, respectively. We intend to
continue to invest in research and development and new products and
technologies to support our customers’ needs for the foreseeable
future.
2022 and Recent Developments
Acquisitions
In January 2022, we completed the acquisition of MyChem, LLC
(“MyChem”), a privately-held San Diego, California-based provider
of ultra-pure nucleotides to customers in the diagnostics, pharma,
genomics and research markets, for a total purchase consideration
of $257.9 million, which includes an estimated fair value of
contingent consideration of $7.8 million as of the acquisition
date. As a result of the acquisition, we own all the outstanding
interest in MyChem. Our consolidated results of operations for the
year ended December 31, 2022 include the operating results of
MyChem from the acquisition date. See Note 2 to our consolidated
financial statements for additional information.
In January 2023, we completed the acquisition of Alphazyme, LLC
(“Alphazyme”), a privately-held original equipment manufacturer
(“OEM”) provider of custom, scalable, molecular biology enzymes to
customers in the genetic analysis and nucleic acid synthesis
markets. The total consideration to acquire Alphazyme consisted of
a base cash purchase price of $70.0 million, subject to customary
post-closing adjustments, and potential performance payments
payable in cash of up to $75.0 million.
Government Assistance
In May 2022, TriLink entered into a cooperative agreement
(“Cooperative Agreement”) with the U.S. Department of Defense, as
represented by the Joint Program Executive Office for Chemical,
Biological, Radiological and Nuclear Defense on behalf of the
Biomedical Advanced Research and Development Authority (“BARDA”),
within the U.S. Department of Health and Human Services, to advance
the development of domestic manufacturing capabilities and to
expand TriLink’s domestic production capacity for products critical
to the development and manufacture of mRNA vaccines and
therapeutics, including nucleoside triphosphates and
CleanCap®,
TriLink’s proprietary co-transcriptional mRNA capping
reagents.
TriLink is expanding its San Diego manufacturing campus by making a
significant investment in additional cleanroom and small molecule
manufacturing space, implementing automation systems and adding
support areas to augment production capacity (the “Flanders San
Diego Facility”). Pursuant to certain requirements, BARDA awarded
TriLink an amount equal to 50% of the construction and validation
costs currently budgeted for the Flanders San Diego Facility. See
Note 6 to our consolidated financial statements for additional
information.
Trends and Uncertainties
COVID-19 Related Revenue Trends and Uncertainties
Since the start of the COVID-19 pandemic in early 2020, our results
of operations and cash flows have substantially benefited from the
strong demand for COVID-19 related products and services, including
our proprietary CleanCap® analogs and highly modified RNA products,
particularly mRNA. We estimate that revenue from COVID-19 related
products and services represented approximately 67.9% and 69.7%,
respectively, of our total revenues for the years ended
December 31, 2022 and 2021, respectively. However, we believe
the second quarter of 2022 represented the highest revenue quarter
for revenue attributable to our COVID-19 related products and
services, with substantial declines in COVID-19 related revenue
expected in the future. In addition to the general market trend of
reduced demand for COVID-19 related products and services as the
pandemic subsides, our COVID-19 related revenue for 2023 may be
negatively impacted by unused inventory of our products that our
customers have on hand. We are unable to estimate the impact of
this unused inventory on future demand given both binding
contractual commitments by our customers for additional purchases
and our customers generally having not provided us with detailed
inventory data. Our longer-term revenue prospects for COVID-19
related products are highly uncertain but are expected to be
substantially less than pandemic highs. There are various
political, social, economic and regulatory factors that could
influence the ongoing manufacture and supply of COVID-19 vaccines,
and in turn, our longer-term COVID-19 related revenue, including:
the emergence, duration and intensity of new virus variants;
emerging information concerning the severity and incidence of the
virus and its variants; competition faced by our customers from
other COVID-19 vaccine manufacturers or developers of alternative
treatments; the availability and administration of pediatric and
booster vaccinations, vaccine supply constraints, vaccine hesitancy
and the effectiveness of vaccines against new virus strains; the
lapsing of the public health emergency declaration made pursuant to
Section 319 of the Public Health Service Act in January 2020;
political and social debate relating to the need for, efficacy of,
or side effects related to one or more specific COVID-19 vaccines;
and the U.S. and global macroeconomic conditions, including impacts
resulting from supply chain constraints, labor market shortages and
inflationary pressures. This contraction in COVID-19 related demand
will significantly decrease our revenue and cash flow, which in
turn could have a material adverse impact on our operating results
and financial condition in the future.
Other Trends and Uncertainties
Biopharmaceutical customers are increasingly relying on outside
parties to provide important inputs and services for their clinical
research and manufacturing, a development driving growth for
suppliers with unique capabilities and the ability to manufacture
at an appropriate scale to support customer programs. We believe
that suppliers like ourselves, with this rare combination of
capabilities, proprietary products and the required investment in
manufacturing and quality systems, are benefiting from rapid growth
as biopharmaceutical customers seek to partner with a small number
of trusted suppliers. In addition to the continued trend toward
outsourcing, several market developments are driving increased
growth, in our addressable market segments, including: (i) pivot
toward mRNA vaccines driven in part by the success of mRNA COVID-19
vaccines; (ii) rapid growth in development of cell and gene
therapies; (iii) large and growing pipeline of protein-based
therapeutics; and (iv) rise in molecular diagnostics driven by
COVID-19.
Our Biologics Safety Testing business continues to see headwinds
from business in Asia, seeing impacts from the ongoing COVID-19
pandemic lockdowns in China and our ongoing decisions not to ship
products into Russia. See more information under Part I, Item 1.
Business.
How We Assess Our Business
We consider a variety of financial and operating measures in
assessing the performance of our business. The key measures we use
to determine how our business is performing are revenue and
Adjusted EBITDA.
Adjusted EBITDA is a non-GAAP financial measure that we define as
net income (loss) adjusted for interest, provision for income
taxes, depreciation, amortization and equity-based compensation
expenses. Adjusted EBITDA reflects further adjustments to eliminate
the impact of certain items, including certain non-cash and other
items, that we do not consider representative of our ongoing
operating performance. We also present Adjusted Free Cash Flow,
which is a non-GAAP measure that we define as Adjusted EBITDA less
capital expenditures.
Management uses Adjusted EBITDA to evaluate the financial
performance of our business and the effectiveness of our business
strategies. We present Adjusted EBITDA and Adjusted Free Cash Flow
because we believe they are frequently used by analysts, investors
and other interested parties to evaluate companies in our industry,
and they facilitate comparisons on a consistent basis across
reporting periods. Further, we believe they are helpful in
highlighting trends in our operating results because they exclude
items that are not indicative of our core operating performance.
Adjusted EBITDA is also a component of the financial covenant under
our credit agreement that governs our ability to access more than
$63.0 million in aggregate letters of credit and available
borrowings under our revolving credit facility. In addition, if we
borrow more than $63.0 million, we are required to maintain a
specified net leverage ratio. See
“Liquidity and Capital Resources—Sources of Liquidity—Debt
Covenants”
for a discussion of this financial covenant.
Adjusted EBITDA and Adjusted Free Cash Flow have limitations as
analytical tools and you should not consider them in isolation, or
as substitutes for analysis of our results as reported under GAAP.
We may in the future incur expenses similar to the adjustments in
the presentation of Adjusted EBITDA. In particular, we expect to
incur meaningful share-based compensation expense in the future.
Other limitations include that Adjusted EBITDA and Adjusted Free
Cash Flow do not reflect:
•all
expenditures or future requirements for capital expenditures or
contractual commitments;
•changes
in our working capital needs;
•provision
for income taxes, which may be a necessary element of our costs and
ability to operate;
•the
costs of replacing the assets being depreciated, which will often
have to be replaced in the future;
•the
non-cash component of employee compensation expense;
and
•the
impact of earnings or charges resulting from matters we consider
not to be reflective, on a recurring basis, of our ongoing
operations.
In addition, Adjusted EBITDA and Adjusted Free Cash Flow may not be
comparable to similarly titled measures used by other companies in
our industry or across different industries.
Components of Results of Operations
Revenue
Our revenue consists primarily of product revenue and, to a much
lesser extent, service revenue. We generated total consolidated
revenue of $883.0 million and $799.2 million for the years ended
December 31, 2022 and 2021, respectively, through the
following segments: (i) Nucleic Acid Production,
(ii) Biologics Safety Testing and (iii) Protein
Detection. We divested our Protein Detection segment in September
2021, and since then operate two business segments only, Nucleic
Acid Production and Biologics Safety Testing.
Nucleic Acid Production Segment
Our Nucleic Acid Production segment focuses on the manufacturing
and sale of highly modified nucleic acids products to support the
needs of customers’ research, therapeutic and vaccine programs.
This segment also provides research products for labeling and
detecting proteins in cells and tissue samples.
Biologics Safety Testing Segment
Our Biologics Safety Testing segment focuses on manufacturing and
selling biologics safety and impurity tests and assay development
services that are utilized by our customers in their biologic drug
manufacturing activities.
Protein Detection Segment
Our Protein Detection segment products, which included a portfolio
of labeling and visual detection reagents, were purchased by our
scientific research customers for their tissue-based protein
detection and characterization needs. In September 2021, we
completed the divestiture of Vector Laboratories, Inc. and
subsidiaries (“Vector”), which made up our Protein Detection
segment.
Cost of Revenue
Cost of revenue associated with our products primarily consists of
manufacturing related costs incurred in the production process,
including personnel and related costs, equity-based compensation
expense, inventory write-downs, costs of materials, labor and
overhead, packaging and delivery costs and allocated costs,
including facilities, information technology, depreciation, and
amortization of intangibles. Cost of revenue associated with our
services primarily consists of personnel and related costs,
equity-based compensation expense, cost of materials and allocated
costs, including facilities and information technology costs. Costs
of services were not material for the years ended December 31,
2022 and 2021.
Operating Expenses
Selling, General and Administrative
Our selling, general and administrative expenses primarily consist
of salaries, benefits and equity-based compensation expense for our
employees in our commercial sales functions, marketing, executive,
accounting and finance, legal and human resource functions as well
as travel expenses, professional services fees, such as consulting,
audit, tax and legal fees, general corporate costs and allocated
costs, including facilities, information technology and
amortization of intangibles.
We expect that our selling, general and administrative expenses
will continue to increase, primarily due to increased headcount and
expanding facilities footprint to support anticipated long-term
growth in the business, costs incurred in increasing our presence
globally, and increases in marketing activities to drive awareness
and adoption of our products and services.
Research and Development
Research and development costs primarily consist of salaries,
benefits, equity-based compensation expense, outside contracted
services, cost of supplies, in-process research and development
costs from asset acquisitions and allocated facilities costs for
employees engaged in research and development of products and
services. We expense all research and development costs in the
period in which they are incurred. Payment made prior to the
receipt of goods or services to be used in research and development
are recognized as prepaid assets until the goods are received or
services are rendered.
We expect our research and development costs to fluctuate in future
periods as we continue our research and development efforts,
including meeting our customers’ needs. These costs may fluctuate
from period to period due to the timing and scope of our
development activities.
Change in Estimated Fair Value of Contingent
Consideration
In the first quarter of 2022, we completed the acquisition of
MyChem and recorded a contingent consideration liability of $7.8
million. In the second quarter of 2022, we recorded a fair value
adjustment to the liability based on our assessment of the
probability of achieving certain revenue thresholds and other
probability factors. This was due to a change in estimate
associated with MyChem revenue projections reaching thresholds that
would trigger a contingent payment per the MyChem Securities
Purchase Agreement (the “MyChem SPA”).
Gain on Sale of Business
In the third quarter of 2021, we completed the sale of Vector,
which represented our Protein Detection business, to Voyager Group
Holdings, Inc. (“Voyager”) and recorded a gain of $11.2
million.
Other Income (Expense)
Interest Expense
Interest expense consist of interest costs and the related
amortization of the debt discount and deferred issuance costs on
our outstanding debt. Interest expense also consists of changes in
the fair value of our interest rate cap agreement.
Interest Income
Interest income consists of interest earned on our cash balances
held at financial institutions.
Loss on Extinguishment of Debt
Loss on extinguishment of debt represent the write-off of remaining
unamortized debt discount and deferred issuance costs on previously
outstanding debt when we engage in refinancing
activities.
Change in Payable to Related Parties Pursuant to the Tax Receivable
Agreement
The Tax Receivable Agreement liability adjustment reflects changes
in the Tax Receivable Agreement liability recorded in our
consolidated statements of financial condition primarily due to
changes in our estimated state apportionment and the corresponding
change of our estimated state tax rate.
Income Tax Expense
As a result of our ownership of LLC Units in Topco LLC, we are
subject to U.S. federal, state and local income taxes with respect
to our allocable share of any taxable income of Topco LLC and will
be taxed at the prevailing corporate tax rates.
Non-Controlling Interests
Non-controlling interests represent the portion of profit or loss,
net assets and comprehensive income or loss of our consolidated
subsidiaries that is not allocable to the Company based on our
percentage of ownership of such entities.
Income or loss attributed to the non-controlling interests is based
on the LLC Units outstanding during the period and is presented on
the consolidated statements of income. As of December 31,
2022, we hold 51.6% of the outstanding LLC Units of Topco LLC and
48.4% of the outstanding LLC Units of Topco LLC are held by MLSH
1.
Results of Operations
The results of operations presented below should be reviewed in
conjunction with the consolidated financial statements and notes
included elsewhere in this Annual Report on Form 10-K.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
|
Change |
|
(in thousands, except per share data) |
|
|
Revenue |
$ |
883,001 |
|
|
$ |
799,240 |
|
|
10.5 |
% |
Operating expenses: |
|
|
|
|
|
Cost of revenue
(1)
|
168,957 |
|
|
140,561 |
|
|
20.2 |
% |
Selling, general and administrative
(1)
|
129,259 |
|
|
100,064 |
|
|
29.2 |
% |
Research and development
(1)
|
18,369 |
|
|
15,219 |
|
|
20.7 |
% |
Change in estimated fair value of contingent
consideration |
(7,800) |
|
|
— |
|
|
* |
Gain on sale of business |
— |
|
|
(11,249) |
|
|
* |
|
|
|
|
|
|
Total operating expenses |
308,785 |
|
|
244,595 |
|
|
26.2 |
% |
Income from operations |
574,216 |
|
|
554,645 |
|
|
3.5 |
% |
Other income (expense), net |
(22,744) |
|
|
(23,880) |
|
|
(4.8) |
% |
Income before income taxes |
551,472 |
|
|
530,765 |
|
|
3.9 |
% |
Income tax expense |
60,809 |
|
|
61,515 |
|
|
(1.1) |
% |
Net income |
$ |
490,663 |
|
|
$ |
469,250 |
|
|
4.6 |
% |
Net income attributable to non-controlling interests |
270,458 |
|
|
287,213 |
|
|
(5.8) |
% |
Net income attributable to Maravai LifeSciences Holdings,
Inc. |
$ |
220,205 |
|
|
$ |
182,037 |
|
|
21.0 |
% |
|
|
|
|
|
|
Net income per Class A common share attributable to Maravai
LifeSciences Holdings, Inc.: |
|
|
|
|
|
Basic |
$ |
1.67 |
|
|
$ |
1.59 |
|
|
|
Diluted |
$ |
1.67 |
|
|
$ |
1.56 |
|
|
|
Weighted average number of Class A common shares
outstanding: |
|
|
|
|
|
Basic |
131,545 |
|
|
114,791 |
|
|
|
Diluted |
255,323 |
|
|
257,803 |
|
|
|
Non-GAAP measures: |
|
|
|
|
|
Adjusted EBITDA |
$ |
637,800 |
|
|
$ |
582,820 |
|
|
|
Adjusted Free Cash Flow |
$ |
590,897 |
|
|
$ |
565,821 |
|
|
|
____________________
*Not
meaningful
(1)Includes
equity-based compensation expense as follows (in thousands, except
percentages):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
|
Change |
Cost of revenue |
$ |
4,192 |
|
|
$ |
1,915 |
|
|
118.9 |
% |
Selling, general and administrative |
13,349 |
|
|
8,263 |
|
|
61.6 |
% |
Research and development |
1,129 |
|
|
280 |
|
|
303.2 |
% |
Total equity-based compensation expense |
$ |
18,670 |
|
|
$ |
10,458 |
|
|
78.5 |
% |
Revenue
Consolidated revenue by segment was as follows for the periods
presented (in thousands, except percentages):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
Percentage of Revenue |
|
2022 |
|
2021 |
|
Change |
|
2022 |
|
2021 |
Nucleic Acid Production |
$ |
813,069 |
|
|
$ |
711,864 |
|
|
14.2 |
% |
|
92.1 |
% |
|
89.1 |
% |
Biologics Safety Testing |
69,932 |
|
|
68,417 |
|
|
2.2 |
% |
|
7.9 |
% |
|
8.5 |
% |
Protein Detection |
— |
|
|
18,959 |
|
|
* |
|
— |
% |
|
2.4 |
% |
Total revenue |
$ |
883,001 |
|
|
$ |
799,240 |
|
|
10.5 |
% |
|
100.0 |
% |
|
100.0 |
% |
____________________
*Not
meaningful
Total revenue was $883.0 million for the year ended
December 31, 2022 compared to $799.2 million for the year
ended December 31, 2021, representing an increase of $83.8
million, or 10.5%.
Nucleic Acid Production revenue increased from $711.9 million for
the year ended December 31, 2021 to $813.1 million for the
year ended December 31, 2022, representing an increase of
$101.2 million, or 14.2%. The increase in Nucleic Acid Production
was driven by demand for our proprietary CleanCap analogs as
COVID-19 vaccine manufacturers scaled production earlier in the
year, and for our highly modified RNA products as this technology
becomes incorporated into more therapeutic and vaccine development
programs. For the year ended December 31, 2022, we estimate
that approximately $599.8 million, or 90.8%, of our $660.5 million
CleanCap revenue was a result of customer demand attributable to
COVID-19 vaccines or other COVID-19 related commercial products or
developmental programs. For the year ended December 31, 2021,
we estimate that approximately $557.4 million, or 93.0%, of our
$599.1 million CleanCap revenue was a result of customer demand
attributable to COVID-19 vaccines or other COVID-19 related
commercial products or developmental programs.
Biologics Safety Testing revenue increased from $68.4 million for
the year ended December 31, 2021 to $69.9 million for the year
ended December 31, 2022, representing an increase of $1.5
million, or 2.2%. The increase was driven by growth in the
underlying markets supporting cell and gene therapies, biosimilar
and other biologic programs and growing adoption of
MockV®
technology for viral clearance prediction during biopharmaceutical
manufacturing.
There was no Protein Detection revenue for the year ended
December 31, 2022 due to the sale of our Protein Detection
business segment, which was completed in early September
2021.
Segment Information
Management has determined that adjusted earnings before interest,
tax, depreciation and amortization is the profit or loss measure
used to make resource allocation decisions and evaluate segment
performance. Adjusted EBITDA assists management in comparing the
segment performance on a consistent basis for purposes of business
decision-making by removing the impact of certain items that
management believes do not directly reflect the core operations
and, therefore, are not included in measuring segment performance.
We define Adjusted EBITDA as net income before interest, taxes,
depreciation and amortization, certain non-cash items and other
adjustments that we do not consider in our evaluation of ongoing
operating performance from period to period. Corporate costs, net
of eliminations, are managed on a standalone basis and are not
allocated to segments.
We do not allocate assets to our reportable segments as they are
not included in the review performed by our Chief Operating
Decision Maker for purposes of assessing segment performance and
allocating resources.
As of December 31, 2022, all of our long-lived assets were
located within the United States.
The following schedule includes revenue and adjusted EBITDA for
each of our reportable operating segments (in thousands). We have
revised our presentation for the prior periods below to remove the
presentation of Total Adjusted EBITDA and reconcile the total of
our reportable segments’ measure of profit or loss to income before
income taxes, in addition to net income, and removed corporate
costs, net of eliminations from total reportable segments’ adjusted
EBITDA and included such amounts in the reconciliation to income
before income taxes. Additionally, we have revised our presentation
for the prior
periods below of our total reportable segments’ revenue, in which
we removed intersegment eliminations from our total reportable
segment’s revenue.
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
|
|
|
|
Revenue: |
|
|
|
Nucleic Acid Production |
$ |
813,076 |
|
|
$ |
712,520 |
|
Biologics Safety Testing |
69,932 |
|
|
68,417 |
|
Protein Detection |
— |
|
|
18,959 |
|
Total reportable segments’ revenue |
883,008 |
|
|
799,896 |
|
Intersegment eliminations |
(7) |
|
|
(656) |
|
Total |
$ |
883,001 |
|
|
$ |
799,240 |
|
|
|
|
|
Segment adjusted EBITDA: |
|
|
|
Nucleic Acid Production |
$ |
638,337 |
|
|
$ |
565,254 |
|
Biologics Safety Testing |
54,841 |
|
|
54,440 |
|
Protein Detection |
— |
|
|
6,391 |
|
Total reportable segments’ adjusted EBITDA |
693,178 |
|
|
626,085 |
|
Reconciliation of total reportable segments’ adjusted EBITDA to
income before income taxes |
|
|
|
Amortization |
(24,269) |
|
|
(18,339) |
|
Depreciation |
(7,566) |
|
|
(6,413) |
|
Interest expense |
(20,414) |
|
|
(30,260) |
|
Interest income |
2,338 |
|
|
— |
|
Corporate costs, net of eliminations |
(55,378) |
|
|
(43,265) |
|
Other adjustments: |
|
|
|
Acquisition contingent consideration |
7,800 |
|
|
— |
|
Acquisition integration costs |
(13,362) |
|
|
(44) |
|
|
|
|
|
Equity-based compensation |
(18,670) |
|
|
(10,458) |
|
|
|
|
|
Gain on sale of business |
— |
|
|
11,249 |
|
|
|
|
|
Merger and acquisition related expenses |
(2,416) |
|
|
(1,508) |
|
Financing costs |
(1,078) |
|
|
(2,383) |
|
Acquisition related tax adjustment |
(349) |
|
|
— |
|
Tax Receivable Agreement liability adjustment |
(4,102) |
|
|
6,101 |
|
Chief Executive Officer transition costs |
(2,426) |
|
|
— |
|
Other |
(1,814) |
|
|
— |
|
Income before income taxes |
551,472 |
|
|
530,765 |
|
Income tax expense |
(60,809) |
|
|
(61,515) |
|
Net income |
$ |
490,663 |
|
|
$ |
469,250 |
|
During the year ended December 31, 2022, intersegment revenue
was immaterial between the Nucleic Acid Production and Biologics
Safety Testing segments. During the year ended December 31,
2021, intersegment revenue was $0.7 million between the Nucleic
Acid Production and Protein Detection segments. The intersegment
sales and the related gross margin on inventory recorded at the end
of the period are eliminated for consolidation purposes. Internal
selling prices for intersegment sales are consistent with the
segment’s normal retail price offered to external parties. There
was no commission expense recognized for intersegment sales for the
years ended December 31, 2022 and 2021.
Non-GAAP Financial Measures
Adjusted EBITDA
A reconciliation of net income to Adjusted EBITDA, which is a
non-GAAP measure, is set forth below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
Net income |
$ |
490,663 |
|
|
$ |
469,250 |
|
Add: |
|
|
|
Amortization |
24,269 |
|
|
18,339 |
|
Depreciation |
7,566 |
|
|
6,413 |
|
Interest expense |
20,414 |
|
|
30,260 |
|
Interest income |
(2,338) |
|
|
— |
|
Income tax expense |
60,809 |
|
|
61,515 |
|
EBITDA |
601,383 |
|
|
585,777 |
|
Acquisition contingent consideration
(1)
|
(7,800) |
|
|
— |
|
Acquisition integration costs
(2)
|
13,362 |
|
|
44 |
|
|
|
|
|
Equity-based compensation
(3)
|
18,670 |
|
|
10,458 |
|
|
|
|
|
Gain on sale of business
(4)
|
— |
|
|
(11,249) |
|
|
|
|
|
Merger and acquisition related expenses
(5)
|
2,416 |
|
|
1,508 |
|
Financing costs
(6)
|
1,078 |
|
|
2,383 |
|
Acquisition related tax adjustment
(7)
|
349 |
|
|
— |
|
Tax receivable agreement liability adjustment
(8)
|
4,102 |
|
|
(6,101) |
|
Chief Executive Officer transition costs
(9)
|
2,426 |
|
|
— |
|
Other
(10)
|
1,814 |
|
|
— |
|
Adjusted EBITDA |
$ |
637,800 |
|
|
$ |
582,820 |
|
____________________
(1)Refers
to the change in the estimated fair value of performance payments
related to the acquisition of MyChem, which was completed in
January 2022.
(2)Refers
to incremental costs incurred to execute and integrate completed
acquisitions, and retention payments in connection with these
acquisitions.
(3)Refers
to non-cash expense associated with equity-based
compensation.
(4)Refers
to the gain on the sale of Vector, which was completed in September
2021.
(5)Refers
to diligence, legal, accounting, tax and consulting fees incurred
associated with acquisitions that were pursued but not
consummated.
(6)Refers
to transaction costs related to the refinancing of our long-term
debt and costs from a secondary offering of our common stock that
are not capitalizable or cannot be offset against proceeds from
such transactions.
(7)Refers
to non-cash expense associated with adjustments to the carrying
value of the indemnification asset recorded in connection with the
acquisition of MyChem.
(8)Refers
to the adjustment of our Tax Receivable Agreement liability
primarily due to changes in our estimated state apportionment and
the corresponding change of our estimated state tax
rate.
(9)Refers
to legal fees and other costs associated with the previously
announced Chief Executive Officer leadership transition planned for
the middle of 2023.
(10)Refers
to the loss recognized during the period associated with certain
working capital and other adjustments related to the sale of
Vector, which was completed in September 2021, and a loss incurred
on extinguishment of debt.
Adjusted Free Cash Flow
A reconciliation of Adjusted Free Cash Flow, which is a non-GAAP
measure that we define as Adjusted EBITDA less capital
expenditures, is set forth below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
Adjusted EBITDA |
$ |
637,800 |
|
|
$ |
582,820 |
|
Capital expenditures
(1)
|
(46,903) |
|
|
(16,999) |
|
Adjusted Free Cash Flow |
$ |
590,897 |
|
|
$ |
565,821 |
|
____________________
(1)We
define capital expenditures as: (i) purchases of property and
equipment which are included in cash flows from investing
activities, accounts payable and accrued expenses, offset by
government funding recognized; and (ii) construction costs
determined to be lessor improvements recorded as prepaid lease
payments and right-of-use assets, including portions included in
accounts payable and accrued expenses, offset by government funding
recognized.
Operating Expenses
Operating expenses include the following for the periods presented
(in thousands, except percentages):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
Percentage of Revenue |
|
2022 |
|
2021 |
|
Change |
|
2022 |
|
2021 |
Cost of revenue |
$ |
168,957 |
|
|
$ |
140,561 |
|
|
20.2 |
% |
|
19.1 |
% |
|
17.6 |
% |
Selling, general and administrative |
129,259 |
|
|
100,064 |
|
|
29.2 |
% |
|
14.7 |
% |
|
12.5 |
% |
Research and development |
18,369 |
|
|
15,219 |
|
|
20.7 |
% |
|
2.1 |
% |
|
1.9 |
% |
Change in estimated fair value of contingent
consideration |
(7,800) |
|
|
— |
|
|
* |
|
(0.9) |
% |
|
— |
% |
Gain on sale of business |
— |
|
|
(11,249) |
|
|
* |
|
— |
% |
|
(1.4) |
% |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
$ |
308,785 |
|
|
$ |
244,595 |
|
|
26.2 |
% |
|
35.0 |
% |
|
30.6 |
% |
____________________
*Not
meaningful
Cost of Revenue
Cost of revenue increased by $28.4 million from $140.6 million for
the year ended December 31, 2021 to $169.0 million for the
year ended December 31, 2022, or 20.2%. The increase in cost
of revenue was primarily attributable to an increase in inventory
reserve of $8.0 million as a result of lower projected
manufacturing demand, and an increase in quality control costs of
$6.6 million. The increase was further driven by increases in
amortization expense of $9.2 million for intangible assets
recognized for the MyChem acquisition, an increase in personnel
costs of $6.2 million driven by higher headcount to support Company
growth, and an increase in facilities cost of $3.1 million due to
additional facilities occupied. These were partially offset by a
$7.2 million decrease in labor and overhead costs driven by
improved labor efficiencies.
Gross profit increased by $55.4 million from $658.7 million for the
year ended December 31, 2021 to $714.0 million for the year
ended December 31, 2022. The decrease in gross profit margin
as a percentage of sales was primarily attributable to increases in
inventory reserve, quality control costs, and amortization expense
for newly acquired intangible assets. These are partially offset by
a favorable product mix shift compared to prior
period.
Selling, General and Administrative
Selling, general and administrative expenses increased by $29.2
million from $100.1 million for the year ended December 31,
2021 to $129.3 million for the year ended December 31, 2022,
or 29.2%. The increase was primarily driven by an increase in
personnel costs of $10.6 million, an increase in marketing costs of
$7.5 million attributable to market studies conducted and increased
advertising efforts to help elevate market presence, an increase in
services and other costs of $4.5 million which includes increased
legal fees and transaction costs associated with the acquisition of
MyChem, and an increase in provision for credit losses of $2.6
million driven by increases in outstanding
receivables.
Research and Development
Research and development expenses increased by $3.2 million from
$15.2 million for the year ended December 31, 2021 to $18.4
million for the year ended December 31, 2022, or 20.7%. The
increase was primarily driven by an increase in personnel costs of
$11.7 million, including $9.3 million relating to retention payment
accruals associated with the acquisition of MyChem. This is
partially offset by a decrease in supplies, materials and services
of $8.6 million primarily driven by contracted studies in the prior
year aimed at improvements for manufacturing
processes.
Change in Estimated Fair Value of Contingent
Consideration
The change in estimated fair value of contingent consideration of
$7.8 million for the year ended December 31, 2022 was due to
the decrease in estimated fair value of the liability during the
second quarter of 2022 for the contingent payments associated with
the acquisition of MyChem. This was due to a change in estimate
associated with MyChem revenue projections reaching thresholds that
would trigger a contingent payment per the MyChem SPA.
Gain on Sale of Business
The gain on sale of business of $11.2 million for the year ended
December 31, 2021 was from the sale of Vector in September
2021.
Other Income (Expense)
Other income (expense) includes the following for the periods
presented (in thousands, except percentages):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
Percentage of Revenue |
|
2022 |
|
2021 |
|
Change |
|
2022 |
|
2021 |
Interest expense |
$ |
(20,414) |
|
|
$ |
(30,260) |
|
|
(32.5) |
% |
|
(2.3) |
% |
|
(3.8) |
% |
Interest income |
2,338 |
|
|
— |
|
|
* |
|
0.2 |
% |
|
— |
% |
Loss on extinguishment of debt |
(208) |
|
|
— |
|
|
* |
|
0.0 |
% |
|
— |
% |
Change in payable to related parties pursuant to the Tax Receivable
Agreement |
(4,102) |
|
|
6,101 |
|
|
* |
|
(0.5) |
% |
|
0.8 |
% |
Other income |
(358) |
|
|
279 |
|
|
* |
|
0.0 |
% |
|
0.0 |
% |
Total other income (expense), net |
$ |
(22,744) |
|
|
$ |
(23,880) |
|
|
(4.8) |
% |
|
(2.6) |
% |
|
(3.0) |
% |
____________________
*Not
meaningful
Other expense was $23.9 million for the year ended
December 31, 2021 compared to $22.7 million for the year ended
December 31, 2022, representing a decrease of $1.1 million, or
4.8%. The decrease in expense was attributable to a $9.8 million
decrease in interest expense primarily due to a $10.3 million
change in fair value of the interest rate cap. The decrease was
further driven by a $2.3 million increase in interest income for
interest earned on our new demand deposits held at financial
institutions. These were partially offset by a $10.2 million change
in gain (loss) related to the payable to related parties pursuant
to the Tax Receivable Agreement as a result of changes in our
estimated state income tax apportionment and the corresponding
change of our estimated state income tax rate.
Relationship with GTCR, LLC (“GTCR”)
Prior to our initial public offering (“IPO”), we utilized GTCR for
certain services pursuant to an advisory services agreement. Under
this agreement, GTCR provided us with financial and management
consulting services in the areas of corporate strategy, budgeting
for future corporate investments, acquisition and divestiture
strategies, and debt and equity financings. The advisory services
agreement provided that we pay a $0.1 million quarterly
management fee to GTCR for these services. We also reimbursed GTCR
for out-of-pocket expenses incurred while providing these services.
The advisory services agreement also provided that certain of our
subsidiaries pay placement fees to GTCR of 1.0% of the gross amount
of debt or equity financings. In connection with our IPO, this
advisory services agreement was terminated.
During the years ended December 31, 2022 and 2021, the Company
made distributions of $150.2 million and $153.5 million for tax
liabilities to MLSH 1.
We are also a party to a Tax Receivable Agreement, or TRA, with
MLSH 1, who is primarily owned by GTCR, and MLSH 2 (see Note 14 to
our consolidated financial statements). The TRA provides for the
payment by us to MLSH 1 and MLSH 2,
collectively, of 85% of the amount of tax benefits, if any, that we
actually realize, or in some circumstances are deemed to realize,
from exchanges of LLC Units (together with the corresponding shares
of Class B common stock) for Class A common stock, as a result of
(i) certain increases in the tax basis of assets of Topco LLC and
its subsidiaries resulting from purchases or exchanges of LLC
Units, (ii) certain tax attributes of the entities acquired from
MLSH 1 and MLSH 2 in connection with the Organizational
Transactions, Topco LLC and subsidiaries of Topco LLC that existed
prior to the IPO, and (iii) certain other tax benefits related to
our entering into the TRA, including tax benefits attributable to
payments that we make under the TRA (collectively, the “Tax
Attributes”). Payment obligations under the TRA are not conditioned
upon any Topco LLC unitholders maintaining a continued ownership
interest in us or Topco LLC, and the rights of MLSH 1 and MLSH 2
under the TRA are assignable. There is no stated term for the TRA,
and the TRA will continue until all tax benefits have been utilized
or expired unless we exercise our right to terminate the TRA for an
agreed-upon amount.
We made payments of $35.3 million to MLSH 1 and MLSH 2 pursuant to
the TRA during the year ended December 31, 2022, of which $1.1
million is related to interest. We made payments of $1.3 million to
MLSH 1 and MLSH 2 pursuant to the TRA during the year ended
December 31, 2021. As of December 31, 2022, our liability
under the TRA was $718.2 million.
Liquidity and Capital Resources
Overview
We have financed our operations primarily from cash flow from
operations, borrowings under long-term debt agreements and, to a
lesser extent, the sale of our Class A common stock.
As of December 31, 2022, we had cash of $632.1 million,
retained earnings of $404.8 million, and net income of $490.7
million for the fiscal year ended December 31, 2022. We also
had positive cash flow from operations of $536.0
million.
We have relied on revenue derived from product and services sales,
and equity and debt financings to fund our operations to
date.
Our principal uses of cash have been to fund operations,
acquisitions and capital expenditures, as well as make tax
distributions to MLSH 1, make TRA payments to MLSH 1 and MLSH 2 and
make interest payments and mandatory principal payments on our
long-term debt.
We plan to utilize our existing cash on hand, together with cash
generated from operations, primarily to fund our commercial and
marketing activities associated with our products and services,
continued research and development initiatives, and ongoing
investments into our manufacturing facilities to create
efficiencies and build capacity. We believe our cash on hand, cash
generated from operations and continued access to our credit
facilities, will be sufficient to satisfy our cash requirements
over the next 12 months and beyond.
As a result of our ownership of LLC Units in Topco LLC, the Company
is subject to U.S. federal, state and local income taxes with
respect to its allocable share of any taxable income of Topco LLC
and is taxed at the prevailing corporate tax rates. In addition to
tax expenses, we also will incur expenses related to our operations
and we will be required to make payments under the TRA with MLSH 1
and MLSH 2. Due to the uncertainty of various factors, we cannot
precisely quantify the likely tax benefits we will realize as a
result of LLC Unit exchanges and the resulting amounts we are
likely to pay out to LLC Unitholders of Topco LLC pursuant to the
TRA; however, we estimate that such payments may be substantial.
Assuming no changes in the relevant tax law, and that we earn
sufficient taxable income to realize all tax benefits that are
subject to the TRA, we expect that future payments under the TRA
relating to the purchase by the Company of LLC Units from MLSH 1
and the tax attributes to be approximately $718.2 million and to
range over the next 14 years from approximately $42.3 million to
$63.3 million per year and decline thereafter. Future payments in
respect of subsequent exchanges or financings would be in addition
to these amounts and are expected to be substantial. The foregoing
numbers are estimates and the actual payments could differ
materially. We expect to fund these payments using cash on hand and
cash generated from operations.
As a result of a change of control, material breach, or our
election to terminate the TRA early, (1) we could be required to
make cash payments to MLSH 1 and MLSH 2 that are greater than the
specified percentage of the actual benefits we ultimately realize
in respect of the tax benefits that are subject to the TRA, and (2)
we will be required to make an immediate cash payment equal to the
present value of the anticipated future tax benefits that are the
subject of the TRA, which payment may be made significantly in
advance of the actual realization, if any, of such future tax
benefits. In these situations, our obligations under the TRA could
have a material adverse effect on our liquidity and could have the
effect of delaying, deferring or preventing certain mergers, asset
sales, other forms of business combination, or other changes of
control. There can be no assurance that we will be able to finance
our obligations under the TRA.
In addition to payments to be made under the TRA, we are also
required to make tax distributions to MLSH 1 pursuant to the LLC
Operating Agreement for the portion of income passing through to
them from Topco LLC. During the years ended
December 31, 2022 and 2021, the Company made distributions of
$150.2 million and $153.5 million for tax liabilities to MLSH 1
under this agreement, respectively.
Credit Agreement
The Credit Agreement among Intermediate, Cygnus and TriLink, as the
borrowers, Topco LLC, as holdings, the lenders from time-to-time
party thereto and Morgan Stanley Senior Funding, Inc., as
administrative and collateral agent (as amended, supplemented or
otherwise modified, the “Credit Agreement”), provides us with a
term-loan facility (the “Term Loan”) totaling $600.0 million
and a revolving credit facility (the “Revolving Credit Facility”)
of $180.0 million for letters of credit and loans to be used
for working capital and other general corporate financing purposes.
Borrowings under the Credit Agreement are unconditionally
guaranteed by Topco LLC, along with the existing and future
material domestic subsidiaries of Topco LLC (subject to certain
exceptions) as specified in the respective guaranty agreements and
are secured by a lien and security interest in substantially all of
the assets of existing and future material domestic subsidiaries of
Topco LLC that are loan parties.
In January 2022, the Company entered into an amendment (the
“Amendment”) to the Credit Agreement to: (i) refinance the existing
$544.0 million aggregate principal balance on the First Lien Term
Loan and to replace it with a new Tranche B Term Loan (“Tranche B
Term Loan”), (ii) replace the LIBOR-based interest rate with a Term
Secured Overnight Financing Rate (“SOFR”) based rate, and (iii)
reduce the interest rate margins applicable to the Term Loan and
Revolving Credit Facilities under the Credit Agreement. The
previous interest rate margin on the facilities was, with respect
to each LIBOR-based loan, 3.75% to 4.25% and, with respect to each
base rate-based loan, 2.75% to 3.25% (depending, in each case, on
consolidated first lien leverage). Following the Amendment, the
interest rate margin on the facilities is 3.00%, with respect to
each Term SOFR-based loan, and 2.00%, with respect to each base
rate-based loan. Further, the Amendment reduced the base rate floor
for the term loans from 2.00% to 1.50%, sets the floor for Term
SOFR-based term loans at 0.50% and sets the floor for Term
SOFR-based revolving loans at 0.00%. No other significant terms
under the Credit Agreement were changed in connection with the
Amendment.
The Base Rate is defined in the Credit Agreement as the greatest of
(i) the rate last quoted by The Wall Street Journal as the “Prime
Rate” in the United States, (ii) the NYFRB Rate plus 0.50% per
annum, (iii) the Term SOFR Rate for a one month interest period
plus 1.00% per annum, (iv) solely with respect to the Tranche B
Term Loans, 1.50% per annum and (v) for any loans that are not
Tranche B Term Loans, 1.00% per annum. The “Term SOFR Rate,” as
defined in the Credit Agreement, means with respect to any Term
SOFR Rate Borrowing and for any other tenor comparable to the
applicable interest period, the Term SOFR Reference Rate at
approximately 5:00 a.m., Chicago time, two U.S. Government
Securities Business Days prior to the commencement of such tenor
comparable to the applicable interest period, as such rate is
published by the CME Term SOFR Administrator; provided that in no
event shall the Term SOFR Rate for any interest period (i) for
Tranche B Term Loans be less than 0.50% or (ii) for any other
Loans, be less than 0.00%.
The Tranche B Term Loan became repayable in quarterly payments of
$1.4 million beginning in March 2022, with all remaining
outstanding principal due in October 2027. The Tranche B Term
Loan includes prepayment provisions that allow us, at our option,
to repay all or a portion of the principal amount at any time. The
Revolving Credit Facility allows us to repay and borrow from time
to time until October 2025, at which time all amounts borrowed
must be repaid. Subject to certain exceptions and limitations, we
are required to repay borrowings under the Tranche B Term Loan and
Revolving Credit Facility with the proceeds of certain occurrences,
such as the incurrence of debt, certain equity contributions and
certain asset sales or dispositions.
Commencing with the fiscal year ended December 31, 2021, and each
fiscal year thereafter, the Credit Agreement requires that we make
mandatory prepayments on the Term Loan principal out of certain
excess cash flow, subject to certain step-downs based on the
Company’s first lien net leverage ratio. The mandatory prepayment
shall be reduced to 25% or 0% of the calculated excess cash flow if
the first lien net leverage ratio was equal to or less than
4.75:1.00 or 4.25:1.00, respectively; however, no prepayment is
required to the extent excess cash flow calculated for the
respective period is equal to or less than $10.0 million. As of
December 31, 2022, our first lien net leverage ratio was less
than 4.25:1.00. Thus, a prepayment was not required.
Accrued interest under the Credit Agreement is payable by us
(a) quarterly in arrears with respect to Base Rate loans,
(b) at the end of each interest rate period (or at each
three-month interval in the case of loans with interest periods
greater than three months) with respect to Term SOFR Rate loans,
(c) on the date of any repayment or prepayment and (d) at
maturity (whether by acceleration or otherwise). An annual
commitment fee is applied to the daily unutilized amount under the
Revolving Credit Facility at 0.375% per annum, with one stepdown to
0.25% per annum based on Intermediate’s first lien net leverage
ratio.
Debt Covenants
The Credit Agreement includes financial covenants. One financial
covenant is a consolidated first lien coverage ratio measured as of
the last day of each fiscal quarter. Another requires that, if as
of the end of any fiscal quarter the aggregate amount
of
letters of credit obligations and borrowings under the Revolving
Credit Facility outstanding as of the end of such fiscal quarter
(excluding cash collateralized letters of credit obligations and
letter of credit obligations in an aggregate amount not in excess
of $5.0 million at any time outstanding and for the first four
fiscal quarters ending after October 2020, borrowings of revolving
credit loans made before October 2020) exceeds 35% of the aggregate
amount of all Revolving Credit Commitments in effect as of such
date, then the net leverage ratio of Intermediate may not be
greater than 8.00 to 1.00. For purposes of this covenant, the net
leverage ratio is calculated by dividing outstanding first lien
indebtedness (net of cash) by Adjusted EBITDA over the preceding
four fiscal quarters.
The Credit Agreement also contains negative and affirmative
covenants in addition to the financial covenant, including
covenants that restrict our ability to, among other things, incur
or prepay certain indebtedness, pay dividends or distributions,
dispose of assets, engage in mergers and consolidations, make
acquisitions or other investments, and make changes in the nature
of the business. The Credit Agreement contains certain events of
default, including, without limitation, nonpayment of principal,
interest or other obligations, violation of the covenants,
insolvency, court ordered judgments and certain changes of control.
The Credit Agreement also requires the Company to provide audited
consolidated financial statements to the lenders no later than 120
days after year-end.
As of December 31, 2022, we were in compliance with these
covenants.
As of December 31, 2022, interest rate on the Term Loan was
6.96%.
Tax Receivable Agreement
We are a party to the TRA with MLSH 1 and MLSH 2. The TRA provides
for the payment by us to MLSH 1 and MLSH 2, collectively, of 85% of
the amount of certain tax benefits, if any, that we actually
realize, or in some circumstances are deemed to realize, as a
result of the Organizational Transactions, IPO and any subsequent
purchases or exchanges of LLC Units of Topco LLC. Based on our
current projections of taxable income, and before deduction of any
specially allocated depreciation and amortization, we anticipate
having enough taxable income to utilize most of these tax
benefits.
As of December 31, 2022, our liability under the TRA was
$718.2 million, representing 85% of the calculated tax savings we
anticipated being able to utilize in future years. We may record
additional liabilities under the TRA when LLC Units are exchanged
in the future and as our estimates of the future utilization of the
Tax Attributes, net operating losses and other tax benefits change.
We expect to make payments under the TRA, to the extent they are
required, within 125 days after the extended due date of our U.S.
federal income tax return for such taxable year. Interest on such
payments will begin to accrue from the due date (without
extensions) of such tax return at a rate of LIBOR (or, if LIBOR
ceases to be published, a replacement rate) plus 100 basis points.
Generally. any late payments will continue to accrue interest at
LIBOR (or a replacement rate, as applicable) plus 500 basis points
until such payments are made.
The payment obligations under the TRA are obligations of Maravai
LifeSciences Holdings, Inc. and not of Topco LLC. Although the
actual timing and amount of any payments that may be made under the
TRA will vary, we expect that the aggregate payments that we will
be required to make to MLSH 1 and MLSH 2 will be substantial. Any
payments made by us under the TRA will generally reduce the amount
of overall cash flow that might have otherwise been available to us
or to Topco LLC and, to the extent that we are unable to make
payments under the TRA for any reason, the unpaid amounts will be
deferred and will accrue interest until paid by us. We anticipate
funding ordinary course payments under the TRA from cash flow from
operations of Topco LLC and its subsidiaries, available cash and/or
available borrowings under the Credit Agreement.
Cash Flows
The following table summarizes our cash flows for the periods
presented (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
Net cash provided by (used in): |
|
|
|
Operating activities |
$ |
535,977 |
|
|
$ |
368,570 |
|
Investing activities |
(267,612) |
|
|
105,655 |
|
Financing activities |
(187,499) |
|
|
(159,049) |
|
Effects of exchange rate changes on cash |
— |
|
|
(88) |
|
Net increase in cash |
$ |
80,866 |
|
|
$ |
315,088 |
|
Operating Activities
Net cash provided by operating activities for the year ended
December 31, 2022 was $536.0 million, which was primarily
attributable to a net income of $490.7 million, non-cash
depreciation and amortization of $31.8 million, amortization of
right-of-use assets of $6.3 million, non-cash amortization of
deferred financing costs of $2.8 million, non-cash equity-based
compensation of $18.7 million, non-cash deferred income taxes of
$42.3 million, and non-cash loss on the revaluation of liabilities
under the TRA of $4.1 million. These were partially offset by a
non-cash gain on the change in estimated fair value of contingent
consideration of $7.8 million, and a net cash outflow from the
change in our operating assets and liabilities of $45.1 million,
which is net of government funding of $17.0 million. The net cash
outflow from the change in our operating assets includes $13.4
million relating to an increase in prepaid lease payments for
Flanders I (as defined in Note 7 to our consolidated financial
statements).
Net cash provided by operating activities for the year ended
December 31, 2021 was $368.6 million, which was primarily
attributable to a net income of $469.3 million, non-cash
depreciation and amortization of $24.8 million, non-cash
amortization of right-of-use assets of $8.8 million, non-cash
amortization of deferred financing costs of $2.7 million, non-cash
equity-based compensation of $10.5 million, and non-cash deferred
income taxes of $46.9 million, partially offset by a non-cash gain
on sale of business of $11.2 million, non-cash gain on the
revaluation of liabilities under the TRA of $6.1 million, and a net
cash outflow from the change in our operating assets and
liabilities of $176.6 million.
Investing Activities
Net cash used in investing activities for the year ended
December 31, 2022 was $267.6 million, which was primarily
comprised of $239.0 million for the net cash consideration paid for
the acquisition of MyChem, net cash outflows of $17.1 million for
property and equipment purchases, and $13.3 million of prepaid
lease payments for Flanders II (as defined in Note 7 to our
consolidated financial statements).
Net cash provided by investing activities for the year ended
December 31, 2021 was $105.7 million, which was primarily
comprised of net cash receipts of $120.0 million from the sale of
Vector. This was partially offset by net cash outflows of $14.9
million for property and equipment purchases.
Financing Activities
Net cash used in financing activities for the year ended
December 31, 2022 was $187.5 million, which was primarily
attributable to $150.2 million of distributions for tax liabilities
to non-controlling interest holders, required pursuant to the terms
of the LLC Operating Agreement, $34.2 million of payments to MLSH 1
and MLSH 2 pursuant to the TRA, and $13.9 million of principal
repayments of long-term debt. This was partially offset by proceeds
from borrowings of long-term debt of $8.5 million.
Net cash used in financing activities for the year ended
December 31, 2021 was $159.0 million, which was primarily
attributable to $153.5 million of distributions for tax liabilities
to non-controlling interest holders and $6.0 million of principal
repayments of long-term debt.
Capital Expenditures
Capital expenditures for the year ended December 31, 2022
totaled $46.9 million, which is net of government funding of $18.1
million. Capital expenditures, including costs incurred for lessor
improvements, for the year ending December 31, 2023 are
projected to be in the range of $55.0 million to $65.0 million,
which is net of anticipated government funding of $4.3 million.
This primarily includes new facility construction costs recorded as
prepaid lease payments and equipment purchases for the Flanders San
Diego Facility.
Contractual Obligations and Commitments
The following table summarizes our contractual obligations and
commitments as of December 31, 2022 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments due by period |
|
Total |
|
1 year |
|
2 - 3 years |
|
4 - 5 years |
|
5+ years |
Operating leases
(1)
|
$ |
71,370 |
|
|
$ |
9,886 |
|
|
$ |
20,690 |
|
|
$ |
17,414 |
|
|
$ |
23,380 |
|
|
|
|
|
|
|
|
|
|
|
Debt obligations
(2)
|
538,560 |
|
|
5,440 |
|
|
10,880 |
|
|
522,240 |
|
|
— |
|
TRA payments
(3)
|
718,210 |
|
|
42,254 |
|
|
86,143 |
|
|
88,831 |
|
|
500,982 |
|
Unconditional purchase obligations
(4)
|
3,000 |
|
|
3,000 |
|
|
— |
|
|
— |
|
|
— |
|
Consideration payable
(5)
|
10,000 |
|
|
10,000 |
|
|
— |
|
|
— |
|
|
— |
|
Other commitments
(6)
|
37,082 |
|
|
2,564 |
|
|
6,754 |
|
|
7,166 |
|
|
20,598 |
|
Total |
$ |
1,378,222 |
|
|
$ |
73,144 |
|
|
$ |
124,467 |
|
|
$ |
635,651 |
|
|
$ |
544,960 |
|
_______________
(1)Represents
operating lease payment obligations, excluding any renewal options
we are reasonably certain to execute and have recognized as lease
liabilities. See Note 7 to our consolidated financial statements
for additional information.
(2)Represents
long-term debt principal maturities, excluding interest. See Note 9
to our consolidated financial statements for additional
information.
(3)Reflects
the estimated timing of TRA payments as of December 31, 2022.
Such payments could be due later than estimated depending on the
timing of our use of the underlying tax attributes. See "Risk
Factors-Risks Related to Our Organizational Structure" and Note 14
to our consolidated financial statements for additional information
regarding our liability under the TRA.
(4)Represents
firm purchase commitments to our suppliers.
(5)Represents
an additional amount we may be required to pay to the sellers of
MyChem subject to the completion of certain calculations associated
with acquired inventory. See Note 2 to our consolidated financial
statements for additional information.
(6)Represents
the estimated timing and amounts of lease payments for the Flanders
San Diego Facility that is under construction.
Tax distributions are required under the terms of the Topco LLC
Agreement. As of December 31, 2022, we have made tax
distributions equal to the estimated obligation due for 2022. See
Note 14 to our consolidated financial statements for additional
information regarding tax distributions.
Commencing with the fiscal year ended December 31, 2021, and each
fiscal year thereafter, the Credit Agreement requires mandatory
prepayments of the Term Loan principal upon certain excess cash
flow, subject to certain step-downs based on our first lien net
leverage ratio. The mandatory prepayment shall be reduced to 25% or
0% of the calculated excess cash flow if the first lien net
leverage ratio was equal to or less than 4.75:1.00 or 4.25:1.00,
respectively; however, no prepayment shall be required to the
extent excess cash flow calculated for the respective period is
equal to or less than $10.0 million.. As of December 31, 2022,
our first lien net leverage ratio was less than
4.25:1.00.
In connection with our acquisition of MyChem, we may be required to
make certain payments to its sellers. We may be required to make
additional payments of up to $40.0 million to the sellers of MyChem
dependent upon meeting or exceeding defined revenue targets during
fiscal 2022. We may also be required to make certain payments of
$20.0 million to them as of the second anniversary of the closing
of the acquisition date as long as the sellers of MyChem continue
to be employed by TriLink. We cannot, at this time, determine when
or if the related targets will be achieved or whether the events
triggering the commencement of payment obligations will occur.
Therefore, such payments were not included in the table above. See
Notes 2 and 4 to our consolidated financial statements for
additional details.
Critical Accounting Estimates
We have prepared our consolidated financial statements in
accordance with GAAP. Our preparation of these consolidated
financial statements requires us to make estimates and assumptions
that affect the reported amounts of assets, liabilities, revenue,
expenses and related disclosures in the consolidated financial
statements. Our estimates are based on historical experience and on
various other assumptions that we believe are reasonable under the
circumstances, the results of which form the basis for making
judgments about the carrying value of assets and liabilities that
are not readily apparent from other sources. Actual results could
differ from these estimates under different assumptions or
conditions and any such difference may be material.
Our significant accounting policies are described in more detail in
Note 1 to our consolidated financial statements. We believe the
following discussion addresses our most critical accounting
estimates used in the preparation of our consolidated financial
statements, which require subjective and complex
judgments.
Income Taxes
We are subject to U.S. federal and state income taxes. We are the
controlling member of Topco, LLC, which has been, and will continue
to be, treated as a partnership for U.S. federal and state income
tax purposes. Topco LLC’s subsidiaries are treated as pass-through
entities for federal and state income tax purposes. The income or
loss generated by these entities is not taxed at the LLC level. As
required by U.S. tax law, income or loss generated by these LLCs
passes through to their owners. As such, our tax provision consists
solely of the activities of Maravai Inc. and its subsidiaries prior
to their disposal, as well as our share of income generated by
Topco LLC. We anticipate this structure to remain in existence for
the foreseeable future.
We account for income taxes under the asset and liability method of
accounting. We recognize deferred tax assets and liabilities for
the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and
liabilities and their respective tax bases, as well as for
operating loss and tax credit carryforwards. We measure deferred
tax assets and liabilities using enacted tax rates expected to
apply to taxable income in the years in which we expect to recover
or settle those temporary differences. We recognize the effect of a
change in tax rates on deferred tax assets and liabilities in the
results of operations in the period that includes the enactment
date. We reduce the measurement of a deferred tax asset, if
necessary, by a valuation allowance if it is more likely than not
that we will not realize some or all of the deferred tax
asset.
The realizability of the Company’s deferred tax asset related to
its investment in Topco LLC depends on the Company receiving
allocations of tax deductions for its tax basis in the investment
and on the Company generating sufficient taxable income to fully
offset such deductions. We believe it is more likely than not that
the Company will generate sufficient taxable income in the future
to fully realize any deductions allocated to it from Topco LLC
associated with the reversal of its tax basis as of
December 31, 2022. However, a portion of the deferred tax
asset may only be realizable through the sale or liquidation of the
investment and our ability to generate sufficient capital gains. As
such, a valuation allowance of $23.8 million has been recorded
as of December 31, 2022 to reflect the deferred tax asset that
is more likely than not to not be realized.
We account for uncertain tax positions by recognizing the financial
statement effects of a tax position only when, based upon technical
merits, it is more likely than not that the position will be
sustained upon examination.
Significant judgment is required in determining the accounting for
income taxes. In the ordinary course of business, many transactions
and calculations arise where the ultimate tax outcome is uncertain.
Our judgments, assumptions and estimates relative to the accounting
for income taxes take into account current tax laws, our
interpretation of current tax laws, and possible outcomes of future
audits conducted by foreign and domestic tax authorities. Although
we believe that our estimates are reasonable, the final tax outcome
of matters could be different from our assumptions and estimates
used when determining the accounting for income taxes. Such
differences, if identified in future periods, could have a material
effect on the amounts recorded in our consolidated financial
statements.
Payable to Related Parties Pursuant to the Tax Receivable
Agreement
In November 2020, we entered into a TRA with MLSH 1 and MLSH 2. The
TRA provides for the payment by us to MLSH 1 and MLSH 2,
collectively, of 85% of the amount of tax benefits, if any, that we
actually realize, or in some circumstances are deemed to realize
from exchanges of LLC Units (together with the corresponding share
of Class B Common stock), as a result of (i) certain increases in
the tax basis of assets of Topco LLC and its subsidiaries resulting
from purchases or exchanges of LLC Units, (ii) increase in the tax
basis of assets of Topco LLC received form LLC Units held by
entities acquired from MLSH 1 and MLSH 2 in connection with the
Organizational Transactions (“the Blocker Entities”), Topco LLC and
subsidiaries of Topco LLC that existed prior to this offering and
(iii) certain other tax benefits related to our entering into the
TRA, including tax benefits attributable to payments that we make
under the TRA (collectively, the “Tax Attributes”). The payment
obligations under the TRA are not conditioned upon any LLC
Unitholder maintaining a continued ownership interest in us or
Topco LLC and the rights of MLSH 1 and MLSH 2 under the TRA are
assignable. We expect to benefit from the remaining 15% of the tax
benefits, if any, that we may actually realize.
We accrue a liability for the payable to related parties for the
TRA and a reduction to stockholders’ equity, when it is deemed
probable that the Tax Attributes will be used to reduce our taxable
income, as the contractual percentage of the benefit of Tax
Attributes that we expected to receive over a period of time. The
current portion, if any, of the liability is the amount estimated
to be paid within one year of the balance sheet date. For purposes
of estimating the value of the payable to related parties for the
TRA, the tax benefit deemed realized by us and payable to MLSH 1
and MLSH 2 is computed by taking 85% of the difference between
undiscounted forecasted cash income tax liability over the term of
benefit of the Tax Attributes and the forecasted amount of such
taxes that we would have been required to pay had there been no Tax
Attributes (i.e. a with-and-without analysis); provided that, for
purposes of determining the tax benefit with respect to state and
local income taxes, use simplifying assumptions. The TRA will
generally apply to each of our taxable years, beginning with the
taxable year that the TRA is entered into. There is no maximum term
for the TRA and the TRA will continue until all such tax benefits
have been utilized or expired unless we exercise our right to
terminate the TRA for an agreed-upon amount equal to the estimated
present value of the remaining payments to be made under the
agreement (calculated with certain assumptions, including as to
utilization of the
Tax Attributes). We may record additional liabilities under the TRA
when LLC Units of Topco LLC are exchanged in the future and as our
estimates of the future utilization of the tax benefits change. If,
due to a change in facts, these tax attributes are not utilized in
future years, it is reasonably possible no amounts would be paid
under the TRA. In this scenario, the reduction of the liability
under the TRA would result in a benefit to our consolidated
statements of income. Subsequent adjustments to the payable to
related parties for the TRA based on changes in anticipated future
taxable income, which could include changes in estimated income
allocated to the partners of Topco LLC or apportionment of state
income taxes, are recorded in our consolidated statements of
income.
The actual Tax Attributes, as well as any amounts paid to MLSH 1
and MLSH 2 under the TRA, will vary depending on a number of
factors, including:
•the
timing of any future exchanges—for instance, the increase in any
tax deductions will vary depending on the fair value, which may
fluctuate over time, of the depreciable or amortizable assets of
Topco LLC and its flow-through subsidiaries at the time of each
exchange;
•the
price of shares of our Class A common stock at the time of any
future exchanges—the increases and adjustments in our proportionate
share of the existing tax basis of the assets of Topco LLC and its
flow-through subsidiaries that are directly related to the price of
shares of our Class A common stock at the time of future
exchanges;
•the
extent to which such exchanges are taxable—if an exchange is not
taxable for any reason, increased tax deductions as a result of
legacy IRC Section 754 election in place at Topco LLC will not be
available to generate payments under the TRA;
•the
amount and timing of our income—the TRA generally will require us
to pay 85% of the tax benefits as and when those benefits are
treated as realized by us under the terms of the TRA. If we do not
have taxable income in a particular taxable year, we generally will
not be required (absent a change of control or other circumstances
requiring an early termination payment) to make payments under the
TRA for that taxable year because no tax benefits will have been
actually realized. Nevertheless, any tax benefits that do not
result in realized tax benefits in a given taxable year will likely
generate tax attributes that may be utilized to generate tax
benefits in future (and possibly previous) taxable years. The
utilization of any such tax attributes will result in payments
under the TRA; and
•applicable
tax rates—the tax rates in effect at the time a tax benefit is
recognized.
The payment obligations under the TRA are obligations of Maravai
LifeSciences Holdings, Inc. and not of Topco LLC. Although the
actual timing and amount of any payments that may be made under the
TRA will vary, we expect that the aggregate payments that we will
be required to make to MLSH 1 and MLSH 2 will be substantial. Any
payments made by us under the TRA will generally reduce the amount
of overall cash flow that might have otherwise been available to us
or to Topco LLC and, to the extent that we are unable to make
payments under the TRA for any reason, the unpaid amounts will be
deferred and will accrue interest until paid by us. We anticipate
funding ordinary course payments under the TRA from cash flow from
operations of Topco LLC and its subsidiaries, available cash and/or
available borrowings under the Credit Agreement.
Assuming no material changes in the relevant tax law, and that we
earn sufficient taxable income to realize all tax benefits that are
subject to the TRA, we expect that future payments under the Tax
Receivable Agreement relating to the purchase by us of LLC Units
from MLSH 1 in connection with our prior offering and subsequent
exchanges and financing, to be approximately $718.2 million and to
range over the next 14 years from approximately $42.3 million to
$63.3 million per year and decline thereafter. Future payments in
respect of subsequent exchanges or financing would be in addition
to these amounts and are expected to be substantial. The foregoing
numbers are estimates and actual payments could differ materially.
It is possible that future transactions or events could increase or
decrease the actual tax benefits realized and the corresponding TRA
payments. There may be a material negative effect on our liquidity
if, as a result of timing discrepancies or otherwise, the payments
under the TRA exceed the actual benefits we realize in respect of
the tax attributes subject to the TRA and/or distributions to us by
Topco LLC are not sufficient to permit us to make payments under
the TRA after we have paid taxes.
The term of the TRA commenced upon the completion of our IPO and
will continue until all such tax benefits have been utilized or
expire, unless we exercise our rights to terminate the agreements
or payments under the agreements are accelerated in the event we
materially breach any of our material obligations under the
agreements.
Recognition of Intangible Assets as Part of a Business
Combination
For acquisitions of businesses, we are required to record the
assets acquired and liabilities assumed of acquired businesses at
their respective fair values at the date of acquisition. The
purchase price, which includes the fair value of consideration
transferred, is attributed to the fair value of the assets acquired
and liabilities assumed. The excess of the purchase price of the
acquisition over the fair value of the identifiable net assets of
the acquiree is recorded as goodwill.
Determining the fair value of intangible assets acquired, defined
as the price that would be received to sell an asset or paid to
transfer a liability in an orderly transaction between willing
market participants, requires management to use significant
judgment, including the selection of valuation methodologies,
assumptions about future net cash flows, and discount rates. Each
of these factors can significantly affect the value attributed to
the identifiable intangible asset acquired in a business
combination.
We typically use the discounted cash flow method under the income
approach to estimate the fair value of identifiable intangible
assets acquired in a business combination. For the acquisition of
MyChem, LLC, the estimated fair value of the developed technology
intangible asset was based on the multi-period excess earnings
method. The estimated fair value was developed by discounting
future net cash flows to their present value at market-based rates
of return. We selected the assumptions used in the financial
forecasts using historical data, supplemented by current and
anticipated market conditions, estimated revenue growth rates,
management’s plans, and guideline companies. Some of the more
significant assumptions inherent in estimating the fair value of
this intangible asset included revenue growth rates ranging from
3.0% to 30.6%, technical obsolescent curves ranging from 5.0% to
7.5%, and a discount rate of 16.5%.
The use of alternative estimates and assumptions could increase or
decrease the estimated fair value and amounts allocated to
identifiable intangible assets acquired and future amortization
expense as well as goodwill.
Recent Accounting Pronouncements
See Note 1 to our consolidated financial statements for a
discussion of recent accounting standards and
pronouncements.
Item 7A. Quantitative and Qualitative Disclosures About Market
Risk
Interest Rate Risk
As of December 31, 2022, our primary exposure to interest rate
risk was associated with our variable rate long-term debt.
Borrowings under our Credit Agreement bear interest at a rate equal
to the Base Rate plus a margin of 2.00%, with respect to each Base
Rate-based loan, or the Term SOFR (Secured Overnight Financing
Rate) plus a margin of 3.00% with respect to each Term SOFR-based
loan, subject in each case to an applicable Base Rate or Term SOFR
floor (see Note 9 to our consolidated financial statements).
Interest rates can fluctuate for a number of reasons, including
changes in the fiscal and monetary policies or geopolitical events
or changes in general economic conditions. This could adversely
affect our cash flows.
As of December 31, 2022, we have an interest rate cap
agreement in place to hedge a portion of our variable interest rate
risk on our outstanding long-term debt. The agreement has a
contract notional amount of $500.0 million and entitles us to
receive from the counterparty at each calendar quarter end the
amount, if any, by which a specified floating market rate exceeds
the cap strike interest rate. The floating interest rate is reset
at the end of each three-month period. The contract expires on
January 19, 2025.
We had $538.6 million of outstanding borrowings under our Tranche B
Term Loan and no outstanding borrowings under our Revolving Credit
Facility as of December 31, 2022. For the year ended
December 31, 2022, the effect of a hypothetical 100 basis
point increase or decrease in overall interest rates would have
changed our interest expense by approximately $5.5
million.
We had cash of $632.1 million as of December 31, 2022. Our
cash is held in demand deposits and is not subject to market
risk.
Foreign Currency Risk
All of our revenue is denominated in U.S. dollars. Although
approximately 61.6% of our revenue for the year ended
December 31, 2022 was derived from international sales,
primarily in Europe and Asia Pacific, none of these sales are
denominated in local currency. The majority of our expenses are
generally denominated in the currencies in which they are incurred,
which is primarily in the United States. As we expand our presence
in international markets, to the extent we are required to enter
into agreements denominated in a currency other than the U.S.
dollar, results of operations and cash flows may increasingly be
subject to fluctuations due to changes in foreign currency exchange
rates and may be adversely affected in the future due to changes in
foreign currency exchange rates. To date, we have not entered into
any hedging arrangements with respect to foreign currency risk. As
our international operations grow, we will continue to reassess our
approach to manage our risk relating to fluctuations in currency
rates.
Item 8. Financial Statements and Supplementary Data
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Stockholders and the Board of Directors of Maravai
LifeSciences Holdings, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of
Maravai LifeSciences Holdings, Inc. (the Company) as of
December 31, 2022 and 2021, the related consolidated
statements of income, comprehensive income, changes in
stockholders’ / member’s equity and cash flows for each of the
three years in the period ended December 31, 2022, and the
related notes (collectively referred to as the “consolidated
financial statements”). In our opinion, the consolidated financial
statements present fairly, in all material respects, the financial
position of the Company at December 31, 2022 and 2021, and the
results of its operations and its cash flows for each of the three
years in the period ended December 31, 2022, in conformity
with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States) (PCAOB),
the Company's internal control over financial reporting as of
December 31, 2022, based on criteria established in Internal
Control-Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (2013 framework) and our
report dated February 28, 2023 expressed an unqualified
opinion thereon.
Basis for Opinion