INS.L Regulatory News (INS)

26 March 2018

Instem plc

("Instem" or the "Company")

SEND Contract Extension and SEND Update

A top five preclinical Contract Research Organisation extends its 2018 SEND outsourced Services contract to over $0.5 million

SEND related services increase significantly year-on-year

Instem plc (AIM: INS), a leading provider of IT solutions to the global life sciences market, announces a SEND ("Standard for the Exchange of Nonclinical Data") services contract extension and provides an update for SEND related services.

SEND Services Contract Extension

Following the SEND contract win announced on 16 January 2018, a second top five preclinical Contract Research Organisation ('CRO') has extended its technology enabled outsourced SEND Services contract to in excess of $0.5 million, with an additional $0.4 million contract award, all of which is expected to be recognised this current financial year.

SEND Update

Orders for the Company's technology-enabled SEND Services have grown strongly year-on-year with 25 orders during the two-month period ended 28 February 2018, compared with six orders for the equivalent period last year. The Company has also extended several orders with existing clients in addition to the CRO extension highlighted above.

New orders came from 17 unique clients during the period, compared with six for the equivalent period last year and Instem continues to win the overwhelming majority of all business quoted for.

This rapid growth has largely been driven by the IND ('Investigational New Drug') legislation from the FDA, which mandated that studies started after 17 December 2017 and included in IND regulatory submissions must use the electronic SEND format. This will result in considerably more submissions using the SEND format.

Furthermore, the Company has a strong SEND new business pipeline with both the number and average value of SEND services contracts increasing year on year, as well as a healthy prospect pipeline for its SEND software suite.

Expanded Team

The Company has embarked upon a global recruitment program to help meet contractual client demand and, as planned, has in 2018 added ten highly experienced consultants and information scientists in the UK, USA and India. Instem's outsourced SEND services team of 30 practitioners is the largest dedicated outsourced SEND team in the industry and its software tools & outsourced services are the most widely adopted, serving clients across 18 countries.

Phil Reason, CEO of Instem plc, commented: "Over 50% of the world's marketed drugs have been through some part of the Instem platform at some stage of their development and our market leading SEND technology platform and comprehensive service offering position us well to both upsell SEND services to existing clients and cross-sell SEND services to new customers".

"We remain excited about the SEND market dynamics and are delighted with the strong start to the current year. Given our growing pipeline of new business opportunities and our refocused sales operations, we look forward to building on this momentum during the rest of the current year."

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About Instem

Instem is a leading provider of IT solutions & services to the life sciences market delivering compelling solutions for Study Management and Data Collection; Regulatory Solutions for Submissions and Compliance; and Informatics-based Insight Generation.

Instem solutions are in use by over 500 customers worldwide, including all the largest 25 pharmaceutical companies, enabling clients to bring life enhancing products to market faster. Instem's portfolio of software solutions increases client productivity by automating study-related processes while offering the unique ability to generate new knowledge through the extraction and harmonisation of actionable scientific information.

Instem products and services now address aspects of the entire drug development value chain, from discovery through to market launch. Management estimates that over 50% of all drugs on the market have been through some part of Instem's platform at some stage of their development. To learn more about Instem solutions and its mission please visit instem.com.