What have been Aenova’s highlights in 2022?

2022 was a challenging year for many companies, including CDMOs. The resilience of a business, however, is exhibited best in times of higher pressure. Above all, our promise to customers is high quality and high delivery reliability. We worked incredibly hard in operations, procurement, and all support functions to keep delivery up and to serve customers and patients around the world. We also invested in 40% higher inventory levels to ascertain delivery, but everyone had to get used to longer lead times, as suppliers could not deliver sufficient raw materials on time.

About four years ago, we designed a new growth strategy. First, each site had to become a center of excellence for a certain technology, and second, in each site we made the investment decisions to either expand existing capacities or extend the technology offering. In total, there are 15 new growth platforms at Aenova now, of which eight are commercially online. We created a brand-new sterile fill and finish area (including biologics) for prefilled syringes and RTU vials at our Latina Site, Italy. The breadth of new technologies that we have put online include the new high-potent API facility at our Regensburg site, Germany, the hot melt extrusion and templated inverted particles at our Sisseln site, Switzerland, and the dry powder inhaler/micro-dosed capsule filling in our Münster site, Germany.

Can you expand on Aenova’s focus on micro-dosed capsule filling and dry powder inhalation?

Our development team developed – together with one of our customers – a first-to-market dry powder inhaler generic in the global strive to find more affordable solutions to treat severe respiratory diseases and COPD. This is an attractive market for generic players, as many of the originator drugs in that space are coming off the patent cliff. Expert knowledge to deliver the required aerosolization with a particle size of 1-5 µm over the entire shelf-life is not for everyone, and we can both provide the development services as well as cost-competitive manufacturing.

What are the key takeaways from Aenova’s white paper on “innovation in drug formulations”?

Innovation is particularly important for the world's preferred solid oral dosage forms. However, for most innovative compounds, traditional approaches to solid dosage formulation do not work because they do not solve the challenges of bioavailability and solubility. Over 80% of drug candidates show low aqueous solubility. However, experienced CDMOs can provide companies with access to new formulation and technology methods that improve the bioavailability of difficult-to-formulate compounds.

What is your outlook for the main trends likely to drive the CDMO space in 2023?

Above all, there is an unprecedented increase in demand across all dosage forms and therapeutic areas to an extent that we haven’t seen after two years of abnormality, first reduced demand for medication as part of the pandemic, and second reduced supply availability due to geopolitical crises. This drives organic growth rates at Aenova of over 20%, and it is hard to install all the required capacity in a timely fashion, as equipment manufacturers have a long lead time.

As costs have gone up due to inflation last year, manufacturing prices had to follow, and that means certain products are not viable anymore, and customers will have to exit products or markets. This will put the health authorities and public payors under pressure, as they will have to secure supply from fewer players. Ultimately, patients will suffer, until governments and relevant authorities understand that pricing must be allowed to move with inflation.

What will be the main priorities for Aenova in 2023?

Above all, we need to deal with the unprecedented demand. But that is not enough, as we need to build the pipeline for the next wave of growth, which we see in providing more state-of-the-art, flexible aseptic manufacturing, and concomitant development services.

The strategic role of our Greensboro site is to be a packaging hub both for bulk made in Aenova’s EU sister sites sold into the US or as well as for third-party US customers. It is also a preferred partner for complex manual packaging and kitting operations. We have transformed the site to prescription drug packaging, including serialization and aggregation, and invested in new lines to increase capacity. But clearly, Aenova will have to make strategic acquisitions in the North American market one day.