What have been the main highlights and milestones achieved for Dipharma in 2023? 

AC: Dipharma was able to deliver our forecasted revenue for our consolidated products and services in 2023, delivering on significant critical milestones which were instrumental for our growth and success. One of these milestones was the completion of the expansion of our Kalamazoo site where we now have additional manufacturing capacity and API production capabilities. Another important highlight in 2023 was that Dipharma obtained its second GMP certification from the Regulatory Authority of Brazil, ANVISA, for our Caronno Pertusella site. 

The company also expanded our small molecule R&D Center at our headquarters located in Baranzate, Italy, which more than doubled the area dedicated to analytical R&D activities. This strengthens our analytical capabilities and broadens our expertise for the development of new organic analysis methods and technologies allowing us to offer a wider range of new APIs and advanced intermediates. 

Overall, the US market plays a pivotal role in Dipharma’s business and contributes approximately 40% to the company’s overall turnover. 

How is Dipharma expanding its API portfolio and growing in different markets?

RF: We market our generic APIs worldwide depending on the patent situation and our regulatory compliance in each country. An important element in selecting new generic APIs is the PIV strategy, which helps enhance readiness to be the first filer or supplier in the market. Our experience in developing proprietary chemical processes and alternative solutions to support the generic API industry has been instrumental in our growth and to rapidly expanding our CDMO activities, particularly in the US and European markets.  We continue to execute on our strategy of extending our API portfolio and growing in new markets. In 2023, we actively pursued partnerships and collaborations to broaden our product offering seeking to enter new therapeutic areas. 

What are the demand trends for Dipharma’s products and services in the US?

RF: The US pharmaceutical industry continues to rely on Italy as the leading European source of high-quality APIs, and there is a growing need for innovative manufacturing processes that allow for increased efficiency, reduced costs, ensured regulatory compliance, and overall sustainability. Dipharma’s technology is backed by our strong track record of commitment to quality, and we are in a position to meet these demands. 

How do you forecast the operating environment to look like for CDMOs in 2024? 

AC: The operating environment for CDMOs in the US has been highly variable over the last decade, and in 2022, the CDMO industry faced significant uncertainty mostly due to disruptions at different levels of the supply chain. However, we are seeing positive signals for recovery in 2024, including collaborations between tech and biopharma companies and increased M&A activity. The regulatory framework in the US also supports the growth of CDMOs. 

RF: The life sciences industry is expected to be robust in 2024, driven by advancements in medical technology and the ongoing focus on new drug development and innovation. The growing demand for personalized medicine and specialty drugs presents avenues and opportunities for innovation and new collaborations directly with Innovators, allowing Dipharma to leverage its expertise in developing and manufacturing complex APIs. 

As the firm celebrates its 75th anniversary, what are Dipharma’s main objectives for 2024? 

AC: Dipharma aims to continue to enforce our position, both in the European and the US markets, by leveraging and expanding our technological capabilities. We have a multi-phased global expansion strategy focused on being a trusted partner to our customers and helping them to materialize their goals in a timely fashion. We will continue to invest in our manufacturing capabilities and capacity to meet the growing demand with our API and advanced intermediate services. 

RF: Dipharma is proud to have been reliably serving the life sciences industry for decades and will continue to do so for many years to come. The company will continue to actively seek partnership and collaboration opportunities to be able to meet the demands of the industry and offer tailored solutions to our customers. 2023 was an extraordinary year for innovation. The FDA approved 55 new drugs in 2023, of which 34 were small molecules, which is an over 50% increase compared to 2022. This opens new opportunities for Dipharma in the years to come.