The power of being understood

Август 9, 2022

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The power of being understood

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2. Agenda 0840 Introducing RSM Terry McAdam Robust project selection Terry McAdam 0910 Financial project appraisal Julian
3. SPEAKERS Serial inventor and entrepreneur Derek Young CEO of i360medical Highly accomplished and respected financial expert.
4. Every RSM firm, wherever they are in the world, shares the same high standard of quality
5. RSM IRELAND About us Formerly Baker Tilly Ryan Glennon An Irish Top 10 firm of accountants
6. RSM IRELAND Services
7. RSM IRELAND Terry McAdam Management Consulting Partner Terry leads a team of experienced performance improvement consultants
8. EVERY RSM FIRM, WHEREVER THEY ARE IN THE WORLD, SHARES THE SAME HIGH STANDARD OF QUALITY
9. SELECTING YOUR PROJECT Terry McAdam
10. SELECTING YOUR PROJECT Contents Rationalisation of existing projects/initiatives The business case Resourcing the project Project governance
11. RATIONALISATION OF EXISTING PROJECTS/INITIATIVES
12. SELECTING YOUR PROJECT (cont.) Rationalisation of existing projects/initiatives Prior to launching a new project, prudent to
14. SELECTING YOUR PROJECT (cont.) Stage Gate Review - Process Overview It is an independent confirmation by
15. SELECTING YOUR PROJECT (cont.) Stage Gate Review - Process Overview The emphasis of the Stage Gate
16. SELECTING YOUR PROJECT (cont.) Building Blocks Outputs from the review include a decision (i.e. approved, conditionally
17. Phase-driven go/no-go decision points are identified across the life of the project where activity is reviewed
18. SELECTING YOUR PROJECT (cont.) Best Practice – Review Process Clearly defined roles and responsibilities: define roles
19. SELECTING YOUR PROJECT (cont.) Best Practice - Review Process Clear and concise decision comes from the
20. THE BUSINESS CASE
21. SELECTING YOUR PROJECT (cont.) The Business Case Why do the project? What is the payback period?
22. SELECTING YOUR PROJECT (cont.) The Business Case (cont.) Requires business to consider proposed project in some
23. RESOURCING THE PROJECT
24. SELECTING YOUR PROJECT (cont.) Resourcing the project If project worth doing then must allocate your best
25. SELECTING YOUR PROJECT (cont.) Resourcing the project (cont.)
26. PROJECT GOVERNANCE
27. SELECTING YOUR PROJECT (cont.) Project governance Project sponsor Project steering group Project manager Project team (including
28. SELECTING YOUR PROJECT (cont.) Define project scope, key roles, responsibilities and reporting structures in a Project
29. SELECTING YOUR PROJECT (cont.) Project governance (cont.) Seek to embed a culture, across the business, that
30. CONTINUOUS IMPROVEMENT
31. CONTINUOUS IMPROVEMENT Identifying and agreeing processes which provide the basis for continuous improvement developing a set
32. FINAL THOUGHTS
33. FINAL THOUGHTS We are all constantly undertaking projects. Need to create environment which gives project best
34. FINAL THOUGHTS The approach to delivering projects in a business should be standardised and repeatable Consider
35. FINANCING YOUR PROJECT Julian Caplin
36. RSM IRELAND Julian Caplin Consulting Partner Leading financial advisor, providing corporate finance, business, commercial and financial
37. PROJECT APPRAISAL Overview Project’s viability Financial appraisal Use of financial assumptions Multiple issues outside financial appraisal
38. IDEATION STAGE
39. IDEATION STAGE Sourcing ideas… Personal experience Career development Universities Innovation hubs
40. EARLY STAGE RESOURCES
41. EARLY STAGE RESOURCES Reliance on friends and family Angel investors Support from industry, i.e. research foundations,
42. PROJECT APPRAISAL
43. PROJECT APPRAISAL Early Stage Less sophisticated methods Emotion led Projections highly speculative Point of return on
44. PROJECT APPRAISAL (cont.) LATE STAGE Projections more sophisticated and reduced speculation Key ratios: - Debt ratio
45. PROJECT APPRAISAL (cont.) INVESTOR CONSIDERATIONS Economic environment. Risk levels associated with R&D Prototype Proven track record
46. FUNDING R&D PROJECTS
47. FUNDING R&D PROJECTS Funding Agencies Often government department or agencies Criteria based, often employment driven, innovation,
48. FUNDING R&D PROJECTS (cont.) Venture Capital and Private Equity Private funding and government led initiatives Criteria
49. FUNDING R&D PROJECTS (cont.) Private Investors Looking at investment opportunities Can bring expertise to company through
50. DEREK YOUNG
51. RSM IRELAND Derek Young CEO, i360medical Derek is a inventor and entrepreneur with a background in
52. i360medical A Healthcare Innovation Company 2015 “To generate and commercialise new world-class medical technology solutions, in
53. i360medical Ideation, Development & Commercialisation Ecosystem i360medical In-House Healthcare Ideation Clinician Inventor ideas Healthcare Professional ideas
54. i360medical Board of Directors Derek Young Irl Prof. Oscar Traynor Irl Eamonn Fitzgerald Irl Hermitage Clinic
55. Some Examples of Clinical Experience and inventions include HALs, NOTES, Laparoscopic , Neuro, SILS, bariatric surgery,
56. Ideation Phases Commercialisation Phases ↓ Ideation Partner Finances ↓ Internal & External Grants ↓ Commercial Funding
57. i360medical Innovation Retainer Model for a Hospital/Health System example Idea Eco System Development i360medical Innovation Engineering
58. A Bridge between Clinical and Commercial World : Inventive Physician Cohort Bridges and Connects Potential Acquirers
59. Example output from one of i360medicals US Outreach Innovation Programs Since inception of the program, this
60. Clinical Leads EU USA Middle East Australasia Each Clinical speciality, Clinical Leads manage i360medical Clinical Opinion
61. Clinical Technical & Market Focus 10
62. Ideation, IP and Projects; Global Eco System CCI Start Ups Feinstein Institute Cincinnati Children's Health Irish
63. Innovation; Strategic Structure Australasian Healthcare Systems Irish Healthcare System Finance & Investment Partners FDA Approval CE
64. Thanks Please Contact Derek Young Tel:+353 (0)86 8281551 IRL Tel: +1 516 491 5163 USA Email:
65. GROUP CASE STUDY EXERCISE
66. PLANNING OPPORTUNITIES - INNOVATION INCENTIVES
67. Planning Opportunities – Innovation Incentives Research and Development Tax Credit Knowledge Development Box IP Capital Allowances
68. R&D Tax Credit Overview €25 credit / cash refund for every €100 spent Utilisation Offset against
69. R&D Tax Credit Overview Qualifying Criteria Systematic, investigative or experimental activities Within an approved field of
70. KNOWLEDGE DEVELOPMENT BOX
71. KDB Overview 6.25% tax rate on qualifying profits Entitled to allowance equal to 50% of qualifying
72. KDB Overview Main categories of IP covered by KDB are: Qualifying Patent / Supplementary protection certificated
73. IP CAPITAL ALLOWANCES
74. IP Capital Allowances Overview C.A.’s for costs incurred in acquiring “specified intangible assets” – 3rd party
75. TYPICAL STRUCTURING
76. Split of TradeCo. and IPCo. Parent TradeCo. 3rd party customers License of IP Contracts with 3rd
77. Split of TradeCo. and IPCo - Variation Irish Tax Outcome Potential to significantly reduce the cost
80. Скачать презентацию

Слайд 2

Agenda
0840 Introducing RSM Terry McAdam
Robust project selection Terry McAdam
0910 Financial project appraisal Julian Caplin
0940 Selecting the right

project Derek Young
1015 Coffee
1030 Group case study exercise Terry McAdam
1130 Tax planning opportunities re R&D Julian Caplin
1145 CFO forum Tom Early
1230 Lunch

Слайд 3

SPEAKERS
Serial inventor and entrepreneur
Derek Young CEO of i360medical
Highly accomplished

and respected financial expert.
Julian Caplin Partner

Performance improvement expertise – technology strategy and deployment allied to process automation
Terry McAdam Partner

Слайд 4

Every RSM firm, wherever they are in the world, shares the

same high standard of quality

37,500 MINDS, 730 OFFICES, 110 COUNTRIES, 1 NETWORK.

Слайд 5

RSM IRELAND
About us
Formerly Baker Tilly Ryan Glennon
An Irish Top 10 firm

of accountants and business advisors (no. 8)
Specialist in the mid-market
Mid-market client base – Domestic & International
13 Partners
Specialist & sector led
One of the fastest growing Irish mid-tier firms - 130 staff
Offices in Dublin, Birr and Portlaoise

Слайд 6

RSM IRELAND
Services

Слайд 7

RSM IRELAND
Terry McAdam
Management Consulting Partner
Terry leads a team of experienced performance

improvement consultants
Deliver operational improvement which yields tangible results
Investment in technology and process automation/enhancement
Over twenty years experience
Guided organisations, of varying scale, through the successful design and execution of complex projects or work programmes
Delivering projects nationally and internationally on an ongoing basis

Слайд 8

EVERY RSM FIRM, WHEREVER THEY ARE IN THE WORLD, SHARES THE

SAME HIGH STANDARD OF QUALITY

Слайд 9

SELECTING YOUR PROJECT
Terry McAdam

Слайд 10

SELECTING YOUR PROJECT
Contents
Rationalisation of existing projects/initiatives
The business case
Resourcing the project
Project governance
Continuous

improvement

Слайд 11

RATIONALISATION OF EXISTING PROJECTS/INITIATIVES

Слайд 12

SELECTING YOUR PROJECT (cont.)
Rationalisation of existing projects/initiatives
Prior to launching a new

project, prudent to review existing project portfolio and its performance.
Project gateway approach ensures investments and projects are consistently reviewed to verify they are delivering expected outcomes
Ensure planned/on-going projects and investments remain aligned with the strategic goals of the business
Introduces decision points across life of a project where business can “get off the project bus”
Consistently non-performing projects are continuously monitored and brought to a controlled end early in their life

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SELECTING YOUR PROJECT (cont.)
Stage Gate Review - Process Overview
It is an

independent confirmation by the Stage Gate Review Team to the governance body that all required project reviews have been successfully conducted
The team ensures that the project manager has produced all the required deliverables and addressed all exit criteria for a given phase to permit the project’s advancement to the subsequent phase

Слайд 15

SELECTING YOUR PROJECT (cont.)
Stage Gate Review - Process Overview
The emphasis of

the Stage Gate Review is on the:
successful accomplishment of phase objectives
plans for the next life cycle phase and
risks associated with moving into the next life cycle phase.
Recommended actions arising from the review are issued to the governance body.

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SELECTING YOUR PROJECT (cont.)
Building Blocks
Outputs from the review include a decision

(i.e. approved, conditionally approved, or not approved) and a clear path forward

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Phase-driven go/no-go decision points are identified across the life of the

project where activity is reviewed to provide assurance that appropriate organisational and strategic objectives continue to be observed and achieved.

SELECTING YOUR PROJECT (cont.)

Decision Points

Слайд 18

SELECTING YOUR PROJECT (cont.)
Best Practice – Review Process
Clearly defined roles and

responsibilities:
define roles and responsibilities so that all project participants are clear with regard to expectations and the overall process
Stage Gate Review preparation:
Prior to attending a Stage Gate Review meeting, all in attendance must have reviewed all pertinent documentation and have a good understanding of the project and its performance, the organisational context in which it is operating and the exit criteria for the relevant stage gate

Слайд 19

SELECTING YOUR PROJECT (cont.)
Best Practice - Review Process
Clear and concise decision

comes from the governance body or delegated authority:
Stage Gate Review outputs must be clearly documented and communicated;
Outputs include a decision (i.e. approved, conditionally approved, or not approved) and a clear path forward; and,
A plan of action and milestones for corrective action, if required, should be defined along with a clear understanding of the oversight process that will be applied to support the implementation of the additional controls sought

Слайд 20

THE BUSINESS CASE

Слайд 21

SELECTING YOUR PROJECT (cont.)
The Business Case
Why do the project? What is

the payback period?

Слайд 22

SELECTING YOUR PROJECT (cont.)
The Business Case (cont.)
Requires business to consider proposed

project in some depth. Aids buy-in of key management and people
Assumptions re potential impact of project are critical
Consider financial and non-financial benefits (risk mitigation, better communication, enhanced quality)
Beware of drive for false precision within projects causing paralysis/delay

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RESOURCING THE PROJECT

Слайд 24

SELECTING YOUR PROJECT (cont.)
Resourcing the project
If project worth doing then must

allocate your best people
Consider all your options to ensure ‘Business as Usual’ not impacted
Temporary external resources can be allocated to some project roles but proceed with care
Monitor and anticipate project resourcing issues continuously. Ad hoc resourcing decisions can prove expensive.

Слайд 25

SELECTING YOUR PROJECT (cont.)
Resourcing the project (cont.)

Слайд 26

PROJECT GOVERNANCE

Слайд 27

SELECTING YOUR PROJECT (cont.)
Project governance
Project sponsor
Project steering group
Project manager
Project team (including

subject matter experts)
Checkpoint/Steering group meetings
Checkpoint/final reporting
Escalation procedures/reporting lines
Stage gate reviews

Слайд 28

SELECTING YOUR PROJECT (cont.)
Define project scope, key roles, responsibilities and reporting

structures in a Project Initiation Document (PID)

Слайд 29

SELECTING YOUR PROJECT (cont.)
Project governance (cont.)
Seek to embed a culture, across

the business, that allows project managers to declare issues early
Forward looking reporting details the expected activity (and risks) over the upcoming period
Provides a summary of the latest expected outturn – financial and operational
Report formats are defined and not negotiable, once agreed
Project reporting sources are consistent with the finance function reporting
One page narrative accompanies every project financial report template

Слайд 30

CONTINUOUS IMPROVEMENT

Слайд 31

CONTINUOUS IMPROVEMENT
Identifying and agreeing processes which provide the basis for continuous

improvement
developing a set of relevant key performance indicators will drive the required behaviours over the longer term
continuous improvement is an on-going internal, and often multi-disciplinary, effort seeking incremental performance improvement over time
sustained focus on waste eradication and quality

Слайд 32

FINAL THOUGHTS

Слайд 33

FINAL THOUGHTS
We are all constantly undertaking projects.
Need to create environment which

gives project best chance
Projects are resource hungry. Internal costs are often significant
Identifying key processes and datasets is the best starting point to de-risk projects
Underperforming projects are identified early and brought to an organised end

Слайд 34

FINAL THOUGHTS
The approach to delivering projects in a business should be

standardised and repeatable
Consider a Project Management Office (PMO) model if need to manage multiple projects centrally
Progress at the pace which is right for the business. Controlled, organised and profitable change is the goal

Слайд 35

FINANCING YOUR PROJECT
Julian Caplin

Слайд 36

RSM IRELAND
Julian Caplin
Consulting Partner
Leading financial advisor, providing corporate finance, business, commercial

and financial advice to a wide range of businesses.
Financial advisory services – MNA, funding structures, strategic financial advise and financial diligence.
Former Director of The Pensions Board (Irish Pension Regulator) and has been involved in arbitration strategies at state level.

Слайд 37

PROJECT APPRAISAL
Overview
Project’s viability
Financial appraisal
Use of financial assumptions
Multiple issues outside financial appraisal
Consider

all aspects in project appraisal

Слайд 38

IDEATION STAGE

Слайд 39

IDEATION STAGE
Sourcing ideas…
Personal experience
Career development
Universities
Innovation hubs

Слайд 40

EARLY STAGE RESOURCES

Слайд 41

EARLY STAGE RESOURCES
Reliance on friends and family
Angel investors
Support from industry, i.e.

research foundations, universities, etc.
Government incentives, e.g. EI, IDA, etc.
Venture funds from larger corporates

Слайд 42

PROJECT APPRAISAL

Слайд 43

PROJECT APPRAISAL
Early Stage
Less sophisticated methods
Emotion led
Projections highly speculative
Point of return on

investment less defined
Investor fatigue

Слайд 44

PROJECT APPRAISAL (cont.)
LATE STAGE
Projections more sophisticated and reduced speculation
Key ratios:
- Debt ratio
- Liquidity

ratio
- Profitability
- Cash flow
Formal valuation methods, including
- Discounted cash flow
- Net present value (NPV)
- Internal rate of return (IRR)
- Payback period
- Scenario analysis

Слайд 45

PROJECT APPRAISAL (cont.)
INVESTOR CONSIDERATIONS
Economic environment.
Risk levels associated with R&D
Prototype
Proven track record

- Pre-sales / feasibility studies
Tax Incentives

Слайд 46

FUNDING R&D PROJECTS

Слайд 47

FUNDING R&D PROJECTS
Funding Agencies
Often government department or agencies
Criteria based, often employment

driven, innovation, environment, etc.
Start-up company criteria may differ – particular funds
Examples include, Enterprise Ireland, the Department of Jobs, Enterprise & Innovation
Benefits include expertise, not seeking pre-determined return on investment, access to information and expertise particularly if doing business abroad
Can be restrictive in terms of criteria, predicated on other events e.g. level of equity from other investors, employment prospects, etc.

Слайд 48

FUNDING R&D PROJECTS (cont.)
Venture Capital and Private Equity
Private funding and government

led initiatives
Criteria based and can include, sector, location, deal size, stage of development
Willing to lend where banks will not, rates relevant to risk
Examples include, Kernal Capital, BlueBay Asset Management, ESB Novusmodus
Benefits include external knowledge, exhausted more conventional financing, sectoral expertise can open new markets and opportunities and potential access to further funding
Can be expensive, early definition of exit strategy, perceived interference in company

Слайд 49

FUNDING R&D PROJECTS (cont.)
Private Investors
Looking at investment opportunities
Can bring expertise to

company through board representation
Often willing to grow with the company
Benefits from not being a corporate which can bring flexibility, varying degrees of involvement depending on agreements and potential access to further funding
Can lead to issues of money versus invention, involvement in the business can seep, lack of corporate type access to markets / knowledge

Слайд 50

DEREK YOUNG

Слайд 51

RSM IRELAND
Derek Young
CEO, i360medical
Derek is a inventor and entrepreneur with

a background in Mechanical Engineering, Surgical Innovation and Business Development from the Austin Waldron and Dublin Institute of Technology.
Specialties
Development of Business Strategy for small to medium companies.
Raising investment through Venture capitalist and Government Grants for start-ups and Projects.
Acquisitions for existing company.
Excellent interactive and interpersonal skills both in terms of staff motivation and teamwork involvement, customer communication and service. Liaising successfully with internal/external Surgeons, customers, consultancies, and contractors thus facilitating teamwork and partnerships.

Слайд 52

i360medical A Healthcare Innovation Company 2015
“To generate and commercialise new world-class medical

technology
solutions, in pursuit of enhanced patient care”
Please Contact Derek Young
Tel:+353 (0)86 8281551 IRL Dublin Office
Tel: +1 516 491 5163 USA New York Office
Email: derekyoung@i360medical.com

Слайд 53

i360medical Ideation, Development & Commercialisation Ecosystem
i360medical In-House
Healthcare Ideation
Clinician Inventor ideas
Healthcare Professional

ideas
Academic Inventor ideas
Engineering Inventor ideas

i360 Multistage Process
Activities include:
Innovation eco system development
Ideation & & Sourcing
International Clinical insights
Ideation & Concept validation
IP Development
Final Device design & development
HIT software development
CE & FDA trials & regulatory approval & reimbursement to commercialisation

Investment Partners
$/€ Externally Managed
aligned Commercial fund. Comprising Private & Institutional Investors.

Healthcare System Partners for Ideation & Qualification to Start-Up
_____________________

Irish private Health

Health HSE

Industry Partners
i360medical maintain relations at ‘C Suite’ level with 11 acquisitive Healthcare MNCs interested in sourcing novel licensing, product and start-up acquisition opportunities.
IP, License, Acquisition Opportunities, Novel Products, SPV/Start-Ups

SJH

Слайд 54

i360medical Board of Directors
Derek Young Irl
Prof. Oscar Traynor Irl
Eamonn Fitzgerald Irl
Hermitage

Clinic

Fergus Clancy Irl
Mater Hosp Private

Prof. Paul Neary Irl

Dr Sean Lyden US
Cleveland Clinic

Dr. Richard Stack US

Bill Starling US

i360medical Board

Слайд 55

Some Examples of Clinical Experience and inventions include HALs, NOTES, Laparoscopic

, Neuro, SILS, bariatric surgery, urology, orthopedics, cardiology, interventional radiology, kidney, gastrointestinal endoscopy, surgical education and training.

Endopath Dextrus
Exit: Ethicon Endo Surgery

Omniport
Exit: Covidien

MediTract
Exit: Davol CR Bard

GelPort
Exit: Applied Medical

Intromit
Exit: TFX Medical

Retractable stent
Exit: Boston Scientific

Triport
Exit: Olympus

Medical device exits with key International Healthcare Multinationals

ProMIS
Exit: CA Health Care

Space-OR
Exit: Johnson & Johnson

xxxxx

A Sample of i360medicals Success and Track Record .

Слайд 56

Ideation Phases Commercialisation Phases
↓ Ideation Partner Finances ↓ Internal

& External Grants ↓ Commercial Funding ↓
Why i360medical?
Our practical experience & expertise and track record. Our global clinical & industry network. We form a ‘bridge for new ideas’.
Benefits of our approach
Accelerates validated ideas & concepts. “Fail quickly” where appropriate.
Independent & Global, objective & detailed analysis. Detailed & practical development roadmaps.
An innovation ecosystem to optimise ROI. A ‘turn key’ for accelerated device commercialization.

Eco system & Identification of new ideas
Assessment of Ideas
Generation of clinical & Commercial opinions globally
Assessment product pipelines / portfolio
Idea categorisation & prioritisation

Brainstorming
Idea selection
Initial Design
Proof of Concept
Clinical, Technical and Market Assessment (CTM)
Initial IP

Design and Prototyping verification
Develop CE & FDA Plan
GLP Wet Labs Trials
Design Freeze

Design to manufacture product
Validation of the Design/product
Development and scale Manufacturing
First-in-Man trial
Initiate CE and FDA plan
Reimbursement plan

Full Multisite Clinical Trial (with partner)
CE & FDA approval

Pre-sell to industry, exit/partner licensee.
Spin Outs, Joint Ventures

Healthcare Innovation Partnership

Formalised Medical Device ‘Idea to Commercialization Process

IDEATION RETAINER+

PROJECT START SPV

PROJECT MID TERM SPV

PROJECT SPV @ FIM

SPV to START UP

START UP

Слайд 57

i360medical Innovation Retainer Model for a Hospital/Health System example
Idea Eco

System Development
i360medical
Innovation Engineering Team US,IRL

Physicians
Clinicians Hospitals
Non Contracted Physicians
& Researchers

Idea Sourcing
Validation
Brainstorm
CTM Review Report & Next Steps
i360medical
Engineering Team US,IRL

i360medical Clinical Team

100 + Inventor Clinicians
Heads of 5- 12 Clinical Depts.

Idea Concept
Development Plan
Budget
CTM Assessment Report & Next Steps
i360medical
Engineering Team US,IRL

i360medical Clinical Team

30 + Inventor Clinicians
Heads of 5 -12 Clinical Depts.

↓ Ideation Partner Finances Internally & Externally Funds ↓

↓ Financed by i360medical 3 Yr. Retainer

Слайд 58

A Bridge between Clinical and Commercial World

Inventive Physician Cohort

Bridges and Connects

Potential Acquirers of your Ideas

Identify Project Funding

Hospital/Health System

Research/OTT/
Innovation Centre

Слайд 59

Example output from one of i360medicals US Outreach Innovation Programs
Since inception

of the program, this Outreach Innovation program has with in 18 months
Established internal ecosystem for:
Disclosing circa 150 ideas and innovations
Engineering support for ideation
Evaluating value proposition
Underwriting intellectual property
Funding translational activities
Three projects prioritized in 2015
Cardiology, General Surgery & Urology
Secured pre-seed project funding for advancing:
Prototypes and validation
Provisional patent filings
Development for Commercial Seed funding
Identified three new Projects in 2016

Innovations % by Speciality

Слайд 60

Clinical Leads
EU
USA
Middle East
Australasia
Each Clinical speciality, Clinical Leads manage i360medical Clinical

Opinion and Idea Providers from EU,USA, Middle East and Australasia.

Our Clinical Leads and Opinion Providers

Слайд 61

Clinical Technical & Market Focus
10

Слайд 62

Ideation, IP and Projects; Global Eco System
CCI Start Ups
Feinstein Institute
Cincinnati

Children's Health
Irish Healthcare System Ideation

Academia & Engineers

Irish
Private & Public Hospitals

DOH & HSE

OTT
Children's

ROW Government Agencies

US Gov & State Agencies
Influential Board of Directors

Finance & Investment Partners

FDA Approval

CE Mark
Multinationals
Healthcare Medical Devices
Global Healthcare Systems

Слайд 63

Innovation; Strategic Structure
Australasian Healthcare Systems
Irish Healthcare System
Finance & Investment Partners
FDA

Approval
CE Mark

US Gov &
State Agencies
Influential Board of Directors

Australasian Agencies

EU Agencies

Слайд 64

Thanks
Please Contact Derek Young
Tel:+353 (0)86 8281551 IRL
Tel: +1 516 491

5163 USA
Email: derekyoung@i360medical.com

Слайд 65

GROUP CASE STUDY EXERCISE

Слайд 66

PLANNING OPPORTUNITIES - INNOVATION INCENTIVES

Слайд 67

Planning Opportunities – Innovation Incentives
Research and Development Tax Credit
Knowledge Development Box
IP

Capital Allowances
Typical Structuring

Слайд 68

R&D Tax Credit Overview
€25 credit / cash refund for every €100

spent
Utilisation
Offset against corporation tax liability in the year in which the claim is made
Carry back and offset against corporation tax in prior year
Cash refund issued in 3 instalments over following 3 years
Refund Mechanism Limitations
Limited to CT paid during 10 previous accounting periods, or
Payroll taxes for period of claim and payroll taxes for preceding year (in certain circumstances)
Refund Mechanism Instalments
Year 1 – 33% of R&D tax credit during the period
Year 2 – 50% of remaining R&D credit carried forward
Year 3 – Remaining 50% of R&D credit carried forward

Слайд 69

R&D Tax Credit Overview
Qualifying Criteria
Systematic, investigative or experimental activities
Within an approved

field of science or technology
Being basic research / applied research / experimental development
Involve the resolution of scientific or technological uncertainty
Seek to achieve scientific or technological advancement
Eligible Expenditure
Salary
Plant and machinery
Raw materials consumed as part of the R&D process
Subcontracted R&D
Power consumed as part of the R&D process
R&D Buildings
Revenue’s Interpretation of Qualifying Expenditure
Allowable Indirect Costs 2011 Guidelines v Allowable Indirect Costs 2015 Guidelines
Appointment of Expert in Revenue Audit Situation

Слайд 70

KNOWLEDGE DEVELOPMENT BOX

Слайд 71

KDB Overview
6.25% tax rate on qualifying profits
Entitled to allowance equal to

50% of qualifying profits
Allowance treated as trading expense of the trade
Modified Nexus Approach
The relief is linked to the proportion of R&D carried on by the Irish company as a percentage of Group R&D
Irish entity must earn income from the exploitation of IP
Income generated from the IP must be recognised in the same entity that undertakes the R&D
Applies to accounting period commencing on or after 1 January 2016
Filing a claim
Irrevocable election into the KDB is made in the CT1 in the year the asset brought within the KDB
Company has 24 months from end of accounting period for electing for KDB treatment to apply to a qualifying asset
Inventions coming off patent can continue to avail of KDB as election is irrevocable

Слайд 72

KDB Overview
Main categories of IP covered by KDB are:
Qualifying Patent /

Supplementary protection certificated for medicinal products / Plant protection certificated / Plant breeder’s rights / Copyrighted Software
IP for SME’s
IP which is “patentable but not yet patented”
Certified as “novel, non-obvious and useful”
Irish Patent Office to make the certification
Documentary Evidence

Слайд 73

IP CAPITAL ALLOWANCES

Слайд 74

IP Capital Allowances Overview
C.A.’s for costs incurred in acquiring “specified intangible

assets” – 3rd party or related party
Qualifying asserts include patents, registered designs, trademarks and names, brand names, domain names, copyrights, know-how, licenses etc. and any goodwill directly attributable to these assets
Acquired from a related party - amount qualifying for relief cannot exceed the market value of the asset
The relief is claimed under one of the following methods:
7% straight line for 14 years followed by 2% straight line in the 15th year
Depreciation/amortisation/impairment charge in the Statement of Comprehensive Income
Restriction on the amounts of allowance that can be offset
The capital allowances can only be offset against income from “relevant activities”
Unutilised capital allowances are carried forward for future offset against relevant trade income

Слайд 75

TYPICAL STRUCTURING

Слайд 76

Split of TradeCo. and IPCo.
Parent
TradeCo.
3rd party customers
License of IP
Contracts with 3rd

Parties

IPCo.

Scenario
The IPCo. owns the rights to the intellectual property.
R&D Employees and Outsourced R&D in IPCo.
The IPCo. licenses the use of the IP rights to the TradeCo. in return for an arm’s length fee.
The TradeCo. contracts directly with third party customers.
Irish Tax Outcome
IPCo. trading profits generally should be taxed at a rate of 6.25% (KDB) / 12.5% provided sufficient skilled workers and management of IP in IPCo.
IP is held in separate company from trading company should there be:
IP Sale only
Trade Sale only
Protects value of IP should there be litigation against TradeCo.
Potential S626B exemption on sale of IPCo if parent in Ireland.
If parent is resident outside of Ireland, any gain on a sale of IPCo is outside the scope of Irish taxation

R&D Employees

Outsourced R&D

Слайд 77

Split of TradeCo. and IPCo - Variation

Irish Tax Outcome
Potential to significantly

reduce the cost of conducting R&D by outsourcing to related party in low cost jurisdiction
However, IPCo cannot avail of R&D tax credit on such outsourced expenditure
IreCo will be entitled to a tax deduction for cost of remunerating related party for undertaking R&D
Arm’s length rate must be agreed with related party
Compare costs of carrying out R&D in Ireland and availing of R&D Tax Credit v outsourcing R&D to related party and not availing of relief

Parent

TradeCo.

3rd party customers

License of IP

Contracts with 3rd Parties

IPCo.

R&D Employees

Outsourced R&D

Outsourced R&D (Related Party)

Слайд 78

The power of being understood

Содержание

Agenda0840 Introducing RSM Terry McAdamRobust project selection Terry McAdam0910 Financial project appraisal Julian Caplin0940 Selecting the right

SPEAKERSSerial inventor and entrepreneur Derek Young CEO of i360medical Highly accomplished

Every RSM firm, wherever they are in the world, shares the

RSM IRELANDAbout usFormerly Baker Tilly Ryan GlennonAn Irish Top 10 firm

RSM IRELANDServices

RSM IRELANDTerry McAdamManagement Consulting PartnerTerry leads a team of experienced performance

EVERY RSM FIRM, WHEREVER THEY ARE IN THE WORLD, SHARES THE

SELECTING YOUR PROJECTTerry McAdam

SELECTING YOUR PROJECTContentsRationalisation of existing projects/initiativesThe business caseResourcing the projectProject governanceContinuous

RATIONALISATION OF EXISTING PROJECTS/INITIATIVES

SELECTING YOUR PROJECT (cont.)Rationalisation of existing projects/initiativesPrior to launching a new

SELECTING YOUR PROJECT (cont.)Stage Gate Review - Process OverviewIt is an

SELECTING YOUR PROJECT (cont.)Stage Gate Review - Process OverviewThe emphasis of

SELECTING YOUR PROJECT (cont.)Building BlocksOutputs from the review include a decision

Phase-driven go/no-go decision points are identified across the life of the

SELECTING YOUR PROJECT (cont.)Best Practice – Review ProcessClearly defined roles and

SELECTING YOUR PROJECT (cont.)Best Practice - Review ProcessClear and concise decision

THE BUSINESS CASE

SELECTING YOUR PROJECT (cont.)The Business CaseWhy do the project? What is

SELECTING YOUR PROJECT (cont.)The Business Case (cont.)Requires business to consider proposed

RESOURCING THE PROJECT

SELECTING YOUR PROJECT (cont.)Resourcing the projectIf project worth doing then must

SELECTING YOUR PROJECT (cont.)Resourcing the project (cont.)

PROJECT GOVERNANCE

SELECTING YOUR PROJECT (cont.)Project governanceProject sponsorProject steering groupProject managerProject team (including

SELECTING YOUR PROJECT (cont.)Define project scope, key roles, responsibilities and reporting

SELECTING YOUR PROJECT (cont.)Project governance (cont.)Seek to embed a culture, across

CONTINUOUS IMPROVEMENT

CONTINUOUS IMPROVEMENTIdentifying and agreeing processes which provide the basis for continuous

FINAL THOUGHTS

FINAL THOUGHTSWe are all constantly undertaking projects.Need to create environment which

FINAL THOUGHTSThe approach to delivering projects in a business should be

FINANCING YOUR PROJECTJulian Caplin

RSM IRELANDJulian CaplinConsulting PartnerLeading financial advisor, providing corporate finance, business, commercial

PROJECT APPRAISALOverviewProject’s viabilityFinancial appraisalUse of financial assumptionsMultiple issues outside financial appraisalConsider