F.I.S Fabbrica Italiana Sintetici S.p.A.

Enabling Better Therapeutics: Interview with CEO Michele Gavino

F.I.S. Fabbrica Italiana Sintetici S.p.A. is one of Europe’s largest contract development and manufacturing organisations (CDMO), specialising in the production of active substances used by leading international pharmaceutical companies worldwide.
F.I.S

Fabbrica Italiana Sintetici (F.I.S) boasts an impressive history. The company was founded in 1957 in Montecchio Maggiore in northern Italy by Giovanni Ferrari and his three sons, with a view to starting a company specialising in the production of active substances for the pharmaceutical industry. Their Montecchio plant was opened in 1958, followed, in 1990, by a second facility in Termoli, focused on the development and production of advanced intermediate products. In 2017, the company achieved another milestone in its expansion, acquiring its third production facility in Lonigo.

Today, F.I.S employs over 2,000 people across its three Italian facilities and is part of the larger Nine Trees Group, a holding operated by the Ferrari Family. “Over the years of our history, we have developed a solid position in the international market as a result of steady organic growth, further solidified by the acquisition of the Lonigo plant in 2017,” says company CEO Michele Gavino.

“We are appreciated for our quality and safety, a key aspect in our industry, as well as for our state-of-the-art technology that we have expanded over the last few years, and that has enabled us to further increase our specific focus on the production of active pharmaceutical ingredients (API), i.e., the biologically active components of a drug product, which we supply to leading pharmaceutical companies.”

“We represent one step of the pharma value chain, a very important one, as APIs are what I call the engines of the final drug,” he further explains. “This is our prime focus – in our specialisation, we can provide the customer with the very best, backed by our investment, our research capability, our quality, and everything we do.”

Key part of the pharma chain

F.I.S specialises in customised products, i.e., intermediates, advanced intermediates and active substances produced exclusively to order for the pharmaceutical companies which hold the patents to them.

The portfolio also includes generic products (active substances such as tranquillisers, anxiolytics, anti-bacterials, analgesics and cardiovasculars) that are offered to the market, products for the veterinary market (both generic and customised), and the supply of integrated services, such as the optimisation of synthesis processes and scaling up.

The company has a strong R&D team numbering 250 people and a total GMP (Good Manufacturing Practice) production capacity

of more than 3,150 m3 across its three Italian plants. Its international presence is supported by two commercial offices in North America and Japan and a representative/procurement office in China.

Consolidating production capacity in a single country is an advantage today, reflects Mr Gavino.

“Before Covid-19, presence in just one country could have been a business limiter. Today, in a world that faces geo-political and supply-chain challenges, location in a stable, well-developed country is a clear benefit.”

“All our three plants are easily accessible with-in just one organisation, with one language, one culture, one system for all.

At the same time, even if local, we are able to offer our customers full flexi-bility. This combination of stability and flexibility is perceived by many of our customers as a benefit that cannot be found in many places around the world,” says Mr Gavino.

Responsible employer

This benefit has been achieved with a well-trained, dedicated workforce.

Over a little more than a decade, the company has increased its staff numbers by more than 200%, while increasing the percentage of women to almost 50% in office roles. “We are lucky in terms of human resources. We are well positioned in one of the richest areas of Europe in northern Italy, with a number of excellent universities and we have programmes in place to recruit and retain the required pool of talent.”

Corporate and social responsibility at F.I.S is built on a desire to improve workplace well-being for employees, in order to foster a suitable corporate culture, with the aim of generating sustainable value with respect for people and the environment. To further contribute to this goal, F.I.S has adopted a Code of Ethics which is shared with employees and everyone operating on behalf of the company.

Environmental issues have been on the company’s agenda for a long time. Since 2017, F.I.S has published annual Sustainability Reports, with the next one (for 2022) due out in June. In addition, in 2022 F.I.S issued a Sustainability Linked Bond, with a value of 350 million euros on expiry in 2027. “The bond is related primarily to three main KPIs – CO2 emissions, reduction of freshwater consumption, and waste treatment,” Mr Gavino acknowledges. “The aim is to reduce all three KPIs by 20% by 2027 against 2021.”

Growing with increased demand

In 2022, the company achieved a turnover of €672 million, an increase of nearly 20% compared to the previous year (of which 74% was generated by custom products) serving a wide portfolio of clients located in sixty countries. Exports accounted for 90% of production, with Europe remaining the key market (67%, of which 11% in Italy), followed by America, Asia, and the rest of the world.

Mr Gavino affirms that F.I.S is set to stay on its growth trajectory. “In the last 4-5 years we have been achieving a CAGR of some 8% and the five-year forecast indicates a similar growth rate. The trend in the pharmaceuticals industry has been to outsource the production of APIs and we have grown in line with this development. “

“We are seeing increased demand in all therapeutic areas where we are present, the areas that are the most important for the present as well as the future of humanity: therapeutics for cancer, diabetes, cardio-vascular, as well diseases of the central nervous system.”

To further support stability, the company will be looking at possible changes to its supply chain, to avoid the situations experienced during, and as a consequence of, the global pandemic, and continue to invest in capacity expansion in all three plants, in line with rising demand.

In the first quarter of 2023, the company achieved an increase of 30% compared to the same period last year.

Mr Gavino commented: “Despite the continuation of highly unstable geopolitical situations and critical issues related to the energy crisis, the results confirmed in the first quarter of 2023 show a positive trend in organic growth as outlined in our strategic plan and allow us to face the coming years with a healthy dose of optimism.”

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