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Kneat Solutions: Validating Our Thesis

Updated September, 2024

TSE:KSI
C$5.39+2.47%
Updated: May 02, 2025
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Executive Summary

Dominating Their Niche In Life Sciences Validation

Validation is a regulated procedure life sciences companies must go through to ensure each batch of product is safe and up to standard. They must validate their process, the equipment used, and the final product. This is done on an ongoing basis and everything needs to be documented for the FDA. Kneat Solutions integrates itself inside a customer's laboratory workflow and offers seamless validation in real-time, replacing a traditionally paper-based system. This is a mission-critical piece of software that is integral to the customer's daily workflow, this makes the product very sticky once integrated. The company dominates the core vertical they are in but is still in the early innings of its growth journey.

Investment Thesis

Overview of buy and sell case of the business.

Why Invest?

Key pieces of information about the business that you need to know about.

Mission Critical Software

Kneat’s solution is a must-have for customers. The validation process in life sciences is a regulated activity, firms have to validate everything they do to remain compliant with the FDA. This creates a very stable base of revenue for investors, the quality of this revenue is only enhanced by the fact that it is all contracted under a SaaS (software-as-a-service) model. Even in tough economic times, pharmaceutical companies will still need to validate everything they do, making Kneat's revenues very defensive.

The solution saves customers a lot of time versus the old paper-based system and importantly, ensures real-time record management in a secure, centralised location for the FDA to audit.

Dominating Their Niche

The company boasts 8 of the top 10 pharmaceutical companies as customers and is roughly 50% penetrated with existing customers. This high-calibre customer base is a massive testament to the product. KSI operate a ‘land and expand’ model, starting new customers on just a single program before expanding to cover the whole organisation over 3-4 years as the product proves its value.

Kneat is deeply integrated into a customer's daily workflow and houses all of their proprietary compliant data, meaning switching to another solution would be very cumbersome.

A Long Runway For Growth

Kneat has multiple avenues for growth;

Increasing penetration of existing customers. Pharma is their core market and they only have ~50% penetration of customer budgets as of 2024, this will continue to grow as their customers roll the product out across all their programs. Merck, one of the world's largest pharmaceutical companies, uses Kneat across its entire organisation.

Expansion into the wide world of validation. Everything regulated by the FDA needs to be validated, meaning the market potential for Kneats solution is massive. This encompasses; Contract Drug Manufacturers, Medical Devices, Food & Beverages, Food Packaging, and more. The company sizes its existing market at $20B, compared to just $40m in revenues as of 2024.

Catalysts

The key events that could drive investment opportunities and shift markets.

Medium term

Expansion Into New Verticals - Today, Kneat's core market is validation for pharmaceutical companies, the next step is toward contract manufacturers who produce drugs for the pharma industry, and then moving towards medical devices and industrial applications. They already have customers in each of these verticals today but as they deepen their relationships and showcase the versatility of the product investors can gain greater confidence in the growth potential.

Near term

Continued Outperformance - Kneat has compounded revenues at 67% since 2019 and the growth prospects remain healthy. They anticipate reporting EBITDA profitability next year, a key milestone for a company early in its development. Gross margins are currently high at 67.8%, indicative of the potential profitability.

Long term

Opening Up To A Larger Shareholder Base - Greater scale should attract more capital. Right now, management has noted that many shareholders simply can’t buy enough shares because the company is still small for a public company. As the company grows into its huge market, share price and liquidity should increase, allowing more institutional shareholders to buy the stock. Other investors, simply stay away from earlier-stage companies and wait a few years until they mature.

Follow the Experts

Quickly navigate key insights from industry experts and leverage their knowledge and market intelligence.

ISPR (International Society for Pharmaceutical Engineering) profile

ISPR (International Society for Pharmaceutical Engineering)

Pharmaceutical Engineering Experts

22k audience

Expert Insights

article
Validation is here to stay—it is an integral part of regulatory requirements and of the manufacturing component of the healthcare environment
Digital Life Sciences profile

Digital Life Sciences

Industry Publication

500 audience

Expert Insights

article
Computer-based systems play a central role when producing and validating pharmaceutical or medicinal products.

Investor Materials

Access the most recent investor updates published by the company.

Key Documents

External Insights

A curated collection of third-party content relevant to the company and sector to help inform your investment decision.

Digitisation in Life Sciences

How Digital Validation is Changing the Pharma Industry

Article

Traditionally, drug development and validation processes have been laborious, time-consuming, and often laden with inefficiencies. However, with advancements in digital technology…

Team

Meet the experienced professionals leading our organization

Edmund Ryan - undefined

Edmund Ryan

Brian Ahearne - undefined

Brian Ahearne

Kevin Fitzgerald - undefined

Kevin Fitzgerald

Hugh Kavanagh - undefined

Hugh Kavanagh

What the Pro's Are Asking

Here are the questions that professional investors are asking before making an investment decision.

What are the key drivers of Kneat’s revenue and profit growth?

Growth will be driven by expansion with existing clients and into new validation verticals. Gross margins are already high at 67%, as an innovator, Kneat spends a considerable amount of money on R&D which will continue to grow but lessen as a percentage of sales. The company will achieve greater leverage on Sales & Marketing / General & Administrative expenses as it expands, allowing more profit to flow through to Net Income.

How is Kneat performing compared to its competitors?

Kneat competes against a legacy paper-based system, internal hybrid digital systems, and some new digital competitors; Val Genesis, HPALM, and Veeva. This industry is ripe for disruption and digital services are much more efficient for customers than traditional paper-based / hybrid systems. Kneat is beating Val Genesis at most bids and dominates their core market. Veeva is a large, well-capitalised competitor who has only recently launched a product in this space and the magnitude of this competitive threat is yet to be seen.

What are the main trends and challenges in the pharmaceutical/life sciences industry at the moment?

Pharmaceutical companies and biotechs have been outsourcing manufacturing over the past two decades as drug manufacturing has become increasingly more complex. This allows those who discover and develop drugs to focus on their core business and not the highly complex and capital-intensive manufacturing process. A consolidation in manufacturing amongst larger players could benefit Kneat as these larger players may have more to spend on efficiency-enhancing software.

What are the biggest challenges for the company?

One of the biggest challenges for Kneat is a long sales cycle, it can take up to two years to win customers and get them set up on the platform. It can then take 2-4 years to roll the solution out to their whole platform. This can slow sales growth but it also demonstrates how sticky a product is once customers have integrated it, making it hard for competitors to take share from Kneat.

Is M&A a part of the strategy?

Near term, the company is focused on its long organic runway but, as they scale management has signalled their appetite for acquisitions of adjacent products. This would be good for investors and increase Kneat's value to the customer. This is a tried and tested business model, there are many platform companies in life sciences catering to many customer needs with a single platform, for example; Veeva.