Questions on the Day
Are you seeing pricing pressure with big pharma balance sheets potentially coming under more pressure?
Cogstate services are critical to trial success, but the Cogstate budget usually makes up a small portion of total trial costs for a bio-pharma sponsor. Therefore, as a general statement, sponsors are more focused on service quality and associated reliability of data than they are on price. To date, Cogstate has not seen substantial price pressure.
We would suggest that smaller biotechs are more price conscious than large pharma companies, reflecting access to capital.
What does Thermo Fisher’s acquisition of Clario mean for Cogstate?
The acquisition of Clario Holdings, Inc. by Thermo Fisher Scientific (NYSE: TMO) is an interesting development in our sector. In 2021, TMO acquired PPD Inc, a previously Nasdaq listed leading contract research organisation (CRO). We can only assume that Clario’s offering will be integrated into PPD. This underscores the appetite from strategics to provide multiple points of solutions as they seek to capture greater share of wallet from customers and as CNS continues to grow as the second largest therapeutic area in clinical trials.
From a Cogstate perspective, we believe that the acquisition potentially provides an opportunity for Cogstate to see additional awards from CROs who may not want to utilise a rater training and eCOA provider who is integrated with a competing CRO, PPD.
From an industry perspective, there is an open question as to whether other CROs, such as IQVIA (NYSE: IQV), ICON (Nasdaq: ICLR), Medpace (Nasdaq: MEDP), will similarly attempt to add specialist services to their offering.
Cogstate’s leadership is confident about its specialty positioning, global reach, and the impact of deep partnerships, such as with Medidata, to maintain and grow market share. The focus remains on innovation, data quality, and customer partnership.
Are any competitors focused on a market outside clinical trials but within cognitive testing?
Most established competitors focus operations primarily on clinical trials. Cogstate, by contrast, also addresses the wider healthcare market, including cognitive screening and assessment tools for physicians and consumers, expanding outside the traditional trial space. The large-scale Eisai partnership in Japan and global non-exclusive deals further illustrate broader reach, but no major competitor has matched this dual focus at scale.
Why are competitors not doing central rating in late-stage Alzheimer’s Disease? Why is Cogstate the only one?
Cogstate is distinguished by its leadership and proprietary innovation in central rating and self-administered digital endpoints, which lend themselves to decentralised trial methods that enable patient centric trial designs and drive high data quality in late-stage Alzheimer’s trials. Central Rating of assessments via telehealth style modalities expanded to Alzheimer’s disease trials only when candidate preventative treatments moved earlier in the disease progression to cognitively normal or mildly impaired individuals, an area where Cogstate has significant market share.
This has provided unique first-mover advantages in an area where regulatory and operational complexities make deep experience invaluable. This is cited as a significant competitive advantage for Cogstate.
What are the catalysts for Cogstate’s materially strengthened commercial momentum outside Alzheimer trials recently, both internally and externally?
In 1Q26, Cogstate executed over $21 million of new clinical trials sales contracts, 33% of which were related to Alzheimer’s disease clinical trials. Other significant areas included Rare Diseases (19%), depression (17%), schizophrenia (14%), and sleep disorders (11%).
Cogstate has recently expanded our services in psychiatric disorders, such as depression and schizophrenia, and we are already seeing the benefit of this new offering.
Our work in Rare Disease has grown steadily over several years and we believe that Cogstate has a commercial edge over our competitors in this space.
Sleep disorders are an area where we believe R&D will increase substantially in coming years, especially with the focus on new orexin therapies, a neuropeptide that plays a key role in regulating sleep-wake cycles. Cogstate digital endpoints have been used successfully as a key endpoint in sleep trials recently and there are several bio-pharma companies competing in this space presently.
In Alzheimer’s disease, Cogstate’s role in successful trials has been important commercial validation of our offering over the last 3-4 years. In earlier stages of the disease, such as pre-clinical Alzheimer’s, Cogstate has unique experience that separates us from our competitors. This experience, combined with our digital assessments that have shown important sensitivity in the earliest stages of disease, has seen us secure most of the industry sponsored work in this space.
Cogstate has reported a substantial increase in new sales opportunities - our shots on goal. We have reported that new sales opportunities identified in the September 2025 quarter were 72% higher than opportunities identified in the September 2024 quarter. We believe that this represents both growth in the market as well as growth in market share. Certainly, the Medidata partnership has impacted identification of new opportunities due to their significant scale and commercial reach.
What approximate percentage of the international market do you think you're getting in your selected target areas?
Estimates vary widely by indication and region, but Cogstate’s share of the CNS/specialised digital assessment trial sub-segment is growing. The clinical trials business accounts for more than 90% of overall company revenue and contracted new business rose 53% year-on-year in FY25. Expanded market share is evident especially in Alzheimer’s disease (where we have recently been awarded work by new customers), rare disease, and psychiatric markets, with penetration into Asia-Pacific and US further increasing.
Would Cogstate ever acquire or build their own eCOA and what, if any, disadvantages exist from not having their own eCOA?
Cogstate is currently delivering eCOA (electronic clinical outcome assessment) solutions through partnerships (notably with Medidata, as well others such as Clinical Ink, Thread, and Y-Prime). The Medidata-Cogstate alliance is positioned as deeply integrated, leveraging best-in-breed solutions from both companies (Cogstate’s digital cognitive assessments and Medidata’s eCOA platform), allowing rapid deployment, compliance, and enhanced data quality. While owning a proprietary eCOA might increase independence, the current model prioritises integration and scalability.
How is Cogstate applying innovation such as AI to its products?
Cogstate is integrating artificial intelligence across its digital cognitive assessments and eCOA platforms to improve the quality, efficiency, and reliability of clinical trial data. Through its partnership with Medidata, Cogstate uses AI-powered automation, smart data analysis, and innovative features like automated rater feedback, simulated rater interactions, and smart transcription, all aimed at enhancing data capture and reducing errors. These tools support faster trial starts, more consistent endpoints, and better data quality, directly benefitting sponsors and trial participants.
The company’s first generation of AI-driven products is designed for scalable automation, real-time rater monitoring, and in-depth cognitive data analysis. By continually investing in advanced data engineering and AI capabilities, Cogstate reinforces its leadership in digital CNS trial innovation and expands its reach into new therapeutic areas, such as psychiatric and rare diseases.
Is revenue dependent on successful clinical trials?
Cogstate’s model earns revenue based on execution and delivery of technology and services for trials, with payments typically milestone-based, linked to trial progress, rather than trial success or regulatory approval. Revenue is not contingent on successful trial outcomes, but rather on the completion of contracted work per phase. This lowers exposure to individual trial outcomes, and future performance is more closely linked to ongoing contract pipeline, trial volumes, and broader CNS R&D market health.