What were the circumstances that brought Kymanox to life and what does your present footprint look like?

Kymanox was founded in 2004 and proposed a new idea at the time – having everything needed for a modern medicine program all under one roof. Most professional service companies hold expertise exclusively in one phase or sector, whereas we have the knowledge to guide innovators through development, regulatory approval, and post-market activities across all of biopharma, medical devices, and any combination thereof. We were motivated by the belief that the industry required an inside partner to drive commercialization success. Fortunately, the outsourcing trend for life science coincided, launching us into a decade of incredible project work, including bringing multiple first-in-class products through FDA and EMA approval.

Since the middle of 2017, we have been in hypergrowth, which Harvard defines as year-over-year growth of 45% or greater. We now have 300 employees, operate throughout the US, and service companies around the globe. Some of our people are now stationed in Europe, and we are expanding geographically as we scale our platform.

What has been fueling the hypergrowth of your business?

It boils down to our unique model. Looking at our field, our closest competitor still does not deliver even half of what we provide to our clients. Decision makers and budget holders are pressed for time, and managing many different suppliers consumes significant portions of their days while adding little value to their core responsibilities. We save them time and restore their focus on what matters: getting products to patients.

What types of companies benefit most from the services that you are providing?

While our services provide critical benefits to all companies in need of support,  companies in their early stages would be ideal clients as we could provide guidance from the very beginning. In reality, these entities do not think about commercialization yet, often lack good funding, and are mostly focusing on achieving their next milestone – so while our value proposition is the strongest for them, we actually do not get a lot of opportunities to offer them support. 

Instead, we get to work with a lot of companies that are in late-stage Phase 3, which means they have to prepare regulatory submissions and be ready to answer to the CMC and Clinical aspects of their programs. This stage is where we usually come in, a circumstance that necessitates massive efforts and our largest teams (sometimes 40+ people), in order to save months or even weeks on product approval. These endeavors are typically more expensive propositions, but because the client has already invested a billion USD or more, they are eager to launch their products as soon as possible. 

Given your understanding of the entire development cycle, which phases do you believe are the most difficult to navigate?

Most companies struggle during the transition from Phase 2B to Phase 3, as management and investor scrutiny increases and there is a lot on the line. Companies also want to accelerate their programs at this point.

There are, however, big changes that are taking shape in modern medicine and that raise new challenges. For instance, there is a strong trend toward combination products (typically a biologic or a drug in drug delivery system). Most Cell and Gene Therapy (C&GT) programs are actually going to be regulated as combination products and will fall under Part 4 in the US. Why? Because these are high value products (a one-time gene therapy infusion can cost more than 3 million USD) and you do not want a nurse to use random hospital stock supplies for delivery; instead, you want to provide a specialized kit that allows the clinician to deliver it in a total foolproof manner. The most forward-looking businesses are focusing on providing this additional certainty, but few have the necessary knowledge in place to wholly address the device aspects of their combination products.

Are there any other emerging trends that have the potential to alter the sector's landscape?

A digital health trend has emerged in the aftermath of the pandemic.

Presently, digital medicine has reached a tipping point, with proliferating algorithms, software programs, and phone apps making medical decisions for patients.

These can be standalone products or very well integrated into a combination product. With the help of digital medicine, the entire disease management process can improve for all stakeholders, including payors.

Big pharma companies can protect their profits by differentiating an existing traditional product with integrated digital enhancements. Even though their products go from being exclusive to generic, a digital layer can create a new, exclusive intellectual property that adds value, including stickiness. Without a doubt, home-based medicine that can be optimally administered with the help of apps will become increasingly important.

In light of this context, what are your top priorities for the next three to five years?

The plan for the next few years is to maintain hypergrowth by continuing our professionalization journey while also scaling up and scaling out. Rather than reinventing ourselves, we will stay true to our brand’s promise and broaden our geographical reach as much as possible. Inorganic growth will also play a role. We validated our M&A value creation formula when we integrated NEUMA to our portfolio following our private equity growth investment in 2021.

Different parts of the company grew at different rates recently, and we want to restore balance there. Investing in digital health and turning it into one of our core competencies, for example, is a key aspect for the period to come, as well as capitalizing on C&GT and related bioprocess manufacturing trends.

What is a final message you would like to leave our audience with?

As an industry, we must manage two unbelievable and unprecedented shortages: talent, on the one hand, and facilities, on the other. To continue bringing life-changing treatments to the world, we will need to collaborate more and share resources. Also, society must recognize that life science businesses must be profitable in order to attract the massive investment in R&D needed to bring new therapies to market. With this mindset in place, we can continue innovating and creating products that benefit society.