ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Repligen and its subsidiaries, collectively doing business as
Repligen Corporation (“Repligen”, “we”, “our”, or “the Company”) is
a global life sciences company that develops and commercializes
highly innovated bioprocessing technologies and systems that
increase efficiencies and flexibility in the process of
manufacturing biological drugs.
As the overall market for biologics continues to grow and expand,
our customers – primarily large biopharmaceutical companies and
contract development and manufacturing organizations – face
critical production cost, capacity, quality and time pressures.
Built to address these concerns, our products are helping to set
new standards for the way biologics are manufactured. We are
committed to inspiring advances in bioprocessing as a trusted
partner in the production of critical biologic drugs – including
monoclonal antibodies (“mAb”), recombinant proteins, vaccines and
gene therapies – that are improving human health worldwide.
We currently operate as one bioprocessing business, with a
comprehensive suite of products to serve both upstream and
downstream processes in biological drug manufacturing. Building on
over 35 years of industry expertise, we have developed a broad and
diversified product portfolio that reflects our passion for
innovation and the customer-first culture that drives our entire
organization. We continue to capitalize on opportunities to
maximize the value of our product platform through both organic
growth initiatives (internal innovation and commercial leverage)
and targeted acquisitions.
Our bioprocessing business is comprised of four main franchises,
three of which we sell directly to
(Chromatography, Filtration and Process Analytics) and one that we
sell primarily through supply agreements (Proteins).
Since 2012, we have significantly expanded our
presence through our Chromatography, Filtration and Process
Analytics franchises, each of which includes novel and
differentiated technologies. We have diversified and grown our
product offering through internal innovation and through strategic,
accretive acquisitions of assets or businesses that leverage
existing product lines and/or expand our customer and geographic
To support our sales growth goals for these products, we make
ongoing investments in our commercial organization, our research
and development (“R&D”) team and our manufacturing capacity.
Our commercial and R&D teams work together to develop and
launch new products and applications that address specific
biomanufacturing challenges, and to build new markets for acquired
technologies. We have six key manufacturing sites across the United
States, Sweden and Germany, with additional capacity being added by
the end of 2020 in the Netherlands. We regularly evaluate and
invest in capacity as needed to ensure timely deliveries and to
stay ahead of increased customer demand for our products.
A substantial piece of our revenue comes from consumable and/or
products as compared to associated equipment. The customization,
convenience of consumable and/or
products, and in many cases the closed nature of our technologies,
make them ideal for use in biologics manufacturing processes where
contamination risk is a critical concern of our customers.
Our Chromatography franchise includes a number of products used in
downstream purification, development, manufacturing and quality
control of biological drugs. The main driver of growth in this
portfolio is our OPUS
column product line.
Additional chromatography products include our affinity capture
resins, such as CaptivA
Protein A resins, that are used in a small number of
commercial drug processes and our ELISA test kits, used by quality
control departments to detect and measure the presence of leached
Protein A and/or growth factor in the final product.
Our Chromatography franchise features a wide range of OPUS columns,
which we deliver to our customers sealed and
with their choice of resin. These are
disposable columns that replace the use of customer-packed glass
columns used in downstream purification processes. By designing
OPUS columns to be a technologically advanced and flexible option
for the purification of biologics from process development through
clinical and commercial-scale manufacturing, Repligen has become a
leader in the
column (“PPC”) market. Our biomanufacturing customers value the
significant cost savings that OPUS columns deliver by reducing set
up time, labor, equipment and facility costs – in addition to
delivering product consistency and “plug and play”