Thomas Loewald, CEO,

CAMBREX

"The growth in large molecules has been extremely impressive, and we are tapping into this market."

Could you provide an overview of Cambrex's core services?

Cambrex is a global CDMO that provides drug substance, drug product, and analytical services across the entire drug lifecycle, helping our customers develop and deliver life-improving therapeutics. In 2021, we celebrated our 40th year with a growing team of over 2,200 employees serving global clients from 12 facilities across North America and Europe.

Cambrex offers clients the ability to work with us from the preclinical stage through the product lifecycle into commercialization. For drug substance we offer a range of technology enabling us to serve most small molecules, including continuous flow, biocatalysis, controlled substances, highly potent products, and a range of production scales from kilo labs to 16,000 liters. We offer a wide range of dosage forms including tablets, capsules, extended-release formulations, liquids, semi-solids, suppositories and pediatric formulations.

How important are small molecule and large molecule therapeutics to Cambrex?

Historically, our core business has been developing and manufacturing small molecule therapeutics. Small and mid-size biotech and pharma companies are leading the way, owning a growing share of the development pipeline compared to their big pharma peers. Additionally, orphan drug approvals account for an increasing proportion of new approvals. We have invested over US$100 million in capacity expansion across clinical and commercial production to meet demand.

Newer to Cambrex is the large molecule space, where we have a rapidly growing analytical business serving biopharmaceutical products and have invested in labs, equipment and talent to support increasing demand. The large molecule market is growing at an even faster rate than the small molecule side, and we see strong demand for analytical services supporting the development and manufacturing of biopharmaceutical products. It was a natural step for us to serve biotherapeutics as we were driven by previous customers requesting we broaden our range of analytical services. We also saw significant overlap in the instrumentation used to support small molecules.

How does Cambrex’s "reverse engineering methodology" in drug development ensure on-time product delivery amid supply chain disruptions?

Using the reverse engineering approach our teams plan projects from the end to the beginning by looking for critical path materials or activities, proactively moving those items off the critical path, then repeating. While this does not make Cambrex completely immune to supply chain disruptions, it ensures the company has the most robust project plan possible before the first raw materials are ordered.

What key trends do you see presently driving the life sciences space, and how do these inform your business strategy?

The first trend is the ownership of the development pipeline and commercialization of new products shifting from large pharma to small and mid-size companies. This has driven an increased level of outsourcing, as smaller companies tend to need more support along the development journey and often own no commercial-scale manufacturing assets. CDMO outsourcing rates are still relatively low, roughly 40-50% depending on the service, and we expect that rate to continue to grow.

The second trend is the emergence of more targeted, personalized medicine with orphan drug approvals now exceeding non-orphan drug approvals. This has two impacts on our business. First, we need more flexible manufacturing assets to support a wide range of batch sizes and the technologies to cover the development of those molecules. For this reason, we are investing in small-scale commercial assets and highly potent technology at our High Point, NC facility. Second, smaller batch sizes lead to a higher level of demand for analytical resources relative to manufacturing assets, as each batch must be tested the same way, whether it is enough material to treat 10 patients or 10,000 patients. We have seen an industry-wide shortage in analytical resources, creating a very strong demand in our analytical service portfolio.

Finally, we have seen robust growth across small and large molecules, but higher growth in new modalities such as cell and gene therapy. The growth in large molecules has been extremely impressive, and we are tapping into this market.

What is Cambrex’s business development strategy for the next few years?

Cambrex has a track record of above-market growth over the past 10 years, and our goal is to continue that trend. We have great organic growth opportunities and will continue to invest heavily in our core business. On the inorganic side, our priorities include adding scale to our core business, complementary technologies that would allow us to serve a broader cross-section of our customers' pipelines, and potentially new services that would increase our exposure to the large molecule market.