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NNIT Copenhagen Winter Seminar2015 Danske Bank 3 December 2015 - PowerPoint PPT Presentation

NNIT Copenhagen Winter Seminar2015 Danske Bank 3 December 2015 Forward looking statements This presentation contains forward- looking statements. Words such as believe, expect, may, will, plan, strategy,


  1. NNIT Copenhagen Winter Seminar2015 Danske Bank 3 December 2015

  2. Forward looking statements This presentation contains forward- looking statements. Words such as ‘believe’, ‘expect’, ‘may’, ‘will’, ‘plan’, ‘strategy’, ‘prospect’, ‘foresee’, ‘estimate’, ‘project’, ‘anticipate’, ‘can’, ‘intend’, ‘outlook’, ‘guidance’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Statements regarding the future are subject to risks and uncertainties that may result in considerable deviations from the outlook set forth. Furthermore, some of these expectations are based on assumptions regarding future events which may prove incorrect. 2

  3. NNIT – who we are Our Core Leveraging Our Compliance DNA Life Public Finance Enterprise Sciences DKK 1,547m DKK 326m DKK 166m DKK 371m (64%) (14%) (7%) (15%) See Note (1) DKK 743m (31%) IT Solutions Services: Advisory services, business solutions and application management DKK 1,667m (69%) IT Operations Services: Infrastructure outsourcing and related consulting, support services Revenue 2014 Note 1. Selection of current NNIT customers, as of February 2015 (contribution to total - %) 3

  4. The Key Pillars of Our Growth Strategy 1 Increase our share of existing customers’ IT spending 2 In Denmark Win new customers 2020 Strategy 3 Support Danish customers with their internationalization Win Profitable Market Share 4 Internationally Life Sciences Supporting Pillars 5 Continue our cost efficiency efforts  6  Continue to promote the highest possible customer satisfaction 7 Enhance our brand and commercial profile  8  Maintain our vision/culture and enhance our Human Capital 4

  5. Life Sciences Our core

  6. Generalist IT Providers are Not Tailored to a Complex Environment Standard Practice to use the V-Model when Complexity of GxP Building Solutions within Life Sciences  Operation of GxP environments requires a high degree of industry and business understanding, as well as audit readiness  GxP compliance includes requirements for:  Secure logging  Auditing  Keeping archives  Accountability  Non-repudiation  Stringent record-keeping requirements and traceability  Litigation and regulation support 6

  7. Strong Expertise in Life Sciences and focused strategy NNIT Delivers Value Added and Leading-edge Solutions tailored to Well- Recognized Pharmaceutical Groups by focusing…  Drug development Pharma value chain  Regulatory Affairs Regulatory driven  Quality management  Supply Chain Selected  Tier 1 – expert knowledge Pharmaceutical  Tier 2 – Scale fit companies  US east cost  Swiss pharma area (Zurich-Basel) Geographical Focus  Germany (Frankfurt area)  UK (South England) 7  China (mainland)

  8. Regulatory environment Drives IT investments Expected Regulatory Changes Lot Traceability Unit serialisation Supply chain Serialisation Serialisation GDP Guidelines Unit serialisation Track & Trace 2015 2016 2017 eCTD v4.0 Regulatory E2B R3 ISO IDMP 2017 2015 2016 Re-evaluation of EDC & RDC technologies (modernising) CDISC, ADaM, SEND Clinical EMA Policy 70: EFPIA Public access to CT Disclosure code data 8

  9. Deep Array of Differentiated Solutions IDMP Integrated Quality Integrated Drug Integrated Drug Integrated Supply FOCUS AREAS Management Regulatory Affairs Development Chain Strategy • • • • Regulatory Clinical Information Compliance Strategic Planning Information • Management Assessments Manufacturing & SC Initiation/ • • R&D IT strategy Management Quality Advisory • RA IT strategy • Analysis Management Quality Control Framework ICE Serialization Transition • • • eClinical • Project Quality Serialisation eDMS Design/ • • CDW/SCE • eSubmission Management PMO Project • Safety • • • QM framework Quality Portals • • Standardisation • Management IDMP QMS Services • CTMS • • SOP’s RIMS • • Portals • Audits Global labelling Improvement Operations/ Continuous • • • • Outsourcing services Outsourcing services QM outsourcing Outsourcing • • • Offshoring Offshoring QMS maintenance services Application • • SaaS Test Offshoring Management Management Support • • • • Application support Application support Application support Application support • • • • Service Desk Service Desk Service Desk Service Desk Application • • • • Onsite Support Onsite Support Onsite Support Onsite Support Support 9

  10. NNIT is ready  NNIT is industry leading IDMP service provider  Industry will start to move to next phase: Implementation ISO IDMP  NNIT have productized FDA’s substance database ( GiNAS) and are exploring the market for GiNAS as a Service  AT&T is SAP’s solution for Serialization of the Pharmaceutical industry and was released September 15, 2015 Serilization  NNIT is qualified SAP AT&T implementation partner and have two Proof of Concept ongoing  NNIT ICE offering is addressing the FDA - Regulatory Submissions in Electronic Format. ICE  NNIT ICE is the out-of-the box full implementation, support and hosting of a Clinical Information Environment 10

  11. Offering GxP Cloud Dedicated to Life Sciences Current GxP Cloud, pre-validated – private Future GxP Cloud, pre-validated – Hybrid: Private and Public Roadmap  Offers the traditional cloud computing benefits such as scalability, elasticity, pay-per-use, monitoring, and availability, and adds:  Full data control with data and applications stored in a secure environment  Security through virtual network separation of customer applications and data  Offers the same as the existing GxP Cloud however based on new technology which allows in future for the opportunity to use NNIT  Compliance with qualified processes and components through or third party Cloud provider organizational and platform audit readiness  Third party provider in so far that NNIT receives information  Agile and fast deployment on a prevalidated platform about processes used to operate and maintain  Lower costs through automation, standardization and shared platforms 11

  12. Life sciences in numbers 9 Month Pct Change Pct Change 2015 2015 (reported) (constant) DKK million (reported) (constant) 2014 Revenue 1,170.3 1,155.6 1,084.3 7.9% 6.6% Hereof Novo Nordisk Group 923.9 915.9 882.6 4.7% 3.8% Hereof other Life Sciences 246.5 239.7 201.7 22.2% 18.8% Clients (in 2015): 34 – excl. China Clients in China (in 2015): 10 *Excl. Novo Nordisk 12

  13. Investor contact information Upcoming events 3 December 2015: Presentation at Danske Bank Markets' Copenhagen Winter Seminar 7 7 January 2015: Presentation at SEB Nordic Seminar, Copenhagen 27 January 2015: Full year 2015 reporting Investor contact NNIT A/S Østmarken 3A 2860 Søborg Denmark Jesper Wagener +45 3075 5392 jvwa@nnit.com 13

  14. Five phases towards IDMP compliance 14

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