Can you introduce Procos and give an overview of the company’s milestones achieved in 2023?

Procos was established in 1945 and is a chemical-pharmaceutical company developing and manufacturing APIs and advanced intermediates for pharma companies. The company is based in Italy and is a wholly-owned subsidiary of the multinational Japanese trading company CBC Co. Ltd Group. We sell our products and services in over 70 countries and have more than 150 customers worldwide. Procos is active in both the custom synthesis and generic API manufacturing areas, where our custom business is focused on the US, European, and Japanese markets, and our generic business is worldwide. Our custom business represents approximately 70% of our turnover.

2023 was a brilliant year for Procos as the company achieved a record turnover of over €200 million –four times the turnover when the company was acquired by CBC in 2006. Can you present Procos’ facilities and capabilities and elaborate on the company’s expansion strategy?

Procos’ cutting-edge multipurpose facility was fully designed under cGMP compliance and has been approved by the main regulatory authorities including AIFA, FDA and PMDA. The company’s main expertise is chemistry, and we are active in both the API and high potency API (HPAPI) business. We have invested approximately US$250 million over 15 years to enhance our capabilities in both segments. Today we have a capacity of 560 cubic meters, five independent production buildings, and over 50 production lines, and we generally manufacture approximately 300 t of intermediates and finished products every year.

In 2023, Procos announced an expansion of our existing HPAPI area by adding two new cGMP units, which were approved by authorities in January 2024. We now have four manufacturing units, as well as dedicated R&D and Quality Control laboratories. Procos is particularly active in the antibody-drug conjugates (ADC) area, and we are mainly manufacturing highly potent drugs, specifically drug linkers. This part of our business is significantly growing, and we are supporting both clinical trials and the commercialization of ADCs. How important is the US market for Procos, and what are the demand trends in this market?

For many years, the US has been the most important market for Procos and contributes approximately 40% to the company’s turnover. The US market is extremely dynamic and incomparable to the European and Japanese markets we also serve.

The range of customers we have in the US market is at the top level. The custom synthesis business is highly dependent on customer needs, and we are supporting our customers in both clinical trials and the commercialization of products in this space. Due to our high level of standards, quality, and R&D, we partner with both big pharma and biotechs, and we are continuously contracting more projects within both segments. Having a good balance between big pharma and biotech customers allows for securing a more constant turnover. What will be the main challenges and opportunities for CDMOs in 2024?

Although Procos has a significantly big plant, we are not an extremely large pharmaceutical company, and the challenge is to offer the top level of services to support our customers. Our efforts, high-quality services and R&D capabilities ensure that we fully meet the needs of our partners in a timely fashion. Companies trying to nearshore or onshore their supply chains create opportunities for CDMOs in the US, and Procos can significantly benefit from these localization efforts. In the current competitive environment where many CDMOs have the capabilities, technology, and capacity, it is crucial to offer added value by having highly skilled people who can provide the right support to the customer throughout their project timeline. Having the added value of highly skilled people is a great competitive advantage for Procos to attract and retain customers. What are Procos’ key priorities and growth strategy in 2024?

Procos will continue to invest in our capabilities and capacity to best meet the needs of our customers. We are currently building a new workshop in which we are specifically going to add small-scale lines to support clinical trial supply and generic product manufacturing. We expect to continue growing in the US market and plan to increase our capacity from 560 cubic meters to 700 cubic meters in the next few years.