What have been the latest developments and achievements for Kindeva over the past 12 months?

MB: At the end of 2022, Kindeva merged with Meridian Medical Technologies to create a market-leading global CDMO focused on drug-device combination products. Over the past year, we have integrated the two companies with a focus on commercial structure and the necessary internal support to take our product offerings to market.

DS: Kindeva made tremendous progress on our new aseptic injectable fill-finish facility in Bridgeton, Missouri. We made significant strides on our green propellant projects and enabling capital investment programs, which will significantly reduce the Global Warming Potential (GWP) of inhalers. We also launched Breyna™, the first FDA-approved generic version of Symbicort®, with our partner, Viatris. Finally, Kindeva also began 2024 with the acquisition of Summit Biosciences, a nasal drug-delivery CDMO. Can you elaborate on the launch of Kindeva’s Analytical Services Global Business Unit?

DS: When we considered the accumulated experience and capabilities across Kindeva and Meridian, it was clear there was incredible depth and breadth of analytical expertise, equipment, and institutional knowledge that had been accumulated during a combined century of developing and supplying combination products. We wanted to open this value to the wider pharmaceutical, biopharmaceutical, and medical device sectors through stand-alone analytical support, whether customers are doing a full program with us or not. Our 32,000-square-foot best-in-class laboratory infrastructure in Minnesota will serve as the central hub for these expanded services. What are the main trends driving the drug delivery market?

MB: There is a lack of capacity in many of the areas Kindeva serves, such as injectables, specifically Annex 1 compliant and newer technologies. In the pulmonary & nasal drug-delivery space, we believe that green propellants are the future for pressurized metered-dose inhalers (pMDIs) and as regulations and legislation around sustainability evolve, demand will increase. These trends correlate to tremendous opportunity as we continue to invest in these key areas. How do you assess the current operating environment for CDMOs in the US?

DS: The biotech funding crunch has driven a more risk-averse approach to early-stage work with innovators who have been forced to conserve cash to extend their runway. This has created headwinds for CDMOs as product development has slowed down.

Increasingly, Chinese and Indian CDMOs have started competing on higher-value parts of the outsourcing supply chain, such as biologics and sterile fill-finish, creating additional pressure on US CDMOs.

The Inflation Reduction Act (IRA) undoubtedly contributed to investors being more circumspect. Any threat to future pricing creates a trickle-down effect for CDMOs, either through fewer development programs or other cost-control measures. CDMOs have already seen greater pressure on generic product pricing due to end market channel consolidation squeezing margins. A cursory look at the FDA’s drug shortage list illustrates it is becoming difficult to produce certain generic products sustainably for several reasons, most of which stem from price pressure.

Lastly, a shift in pharma’s pipeline catalyzes a need for changes to CDMOs’ capacity. Increasingly, the pipeline consists of molecules with poor bioavailability or solubility. Therapies also increasingly target more complex diseases intersecting with smaller patient populations and requiring more complex formulation approaches, smaller batch sizes, or more convenient administration, such as autoinjectors. How does Kindeva leverage AI and automation technologies?

DS: We adopt AI to accelerate the way we model formulation, molecule, and device interactions. This reduces time and cost, expediting development and commercialization.

Our new sterile fill-finish injectable facility utilizes automation to engineer out inefficiency and risk where possible, with the goal of manufacturing injectable medicine while prioritizing patient safety. What are the key priorities for Kindeva to continue growing in 2024 and beyond?

MB: The investments and partnerships Kindeva made in 2023 put us on a great path for 2024. The company will continue to focus on being a premier drug-device combination CDMO across multiple platforms. Our key priorities will be to continue making investments and acquisitions in the drug-device space while forming key industry partnerships.

DS: Scalability is key for Kindeva in 2024. While we are very pleased with the progress to date and believe we have a strong foundation, we also have much we want to further improve.