Global Clinical Operations

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GCO Seminar 2017 – at a glanceVenue: Tivoli hotel

2 October 3 October

09.00 State-of-the-nation – by Paul

Team Work - by Morten Hagen

Training in GCO - by Patrice

Project Unicorn

Networking across teams

(Canal tour)

Lunch Lunch

13:00 –

16:15Data Flow Process – trial teams

/parallel session

Introduction to Clinical Trials

Tralokinumab

Wrap Up by Paul (Q-A)

Special Guest: Ulrik Lynge

19:00 –

02:00Dinner and dance at Tivoli Hotel

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WelcomeBiometrics

Biostat leads• Birgitte Billmann Roenn• Jens Strodl Andersen• Per Sørensen

Biostatistics• Amne Iskandar• Anders Rosholm, • Ken Sejling• Rebecca Zachariae Nielsen• Thor Schuett Svane Nielsen

Data Management• Lisbet Groes• Adomas Derskus• Pankhuri Bahar• Shameer Kustagi

Medical Communication.• Kristine Nørgaard Strandfelt• Anne Okkels Birk• Jasper Neergaard Jacobsen• Corinne Eenschooten• Anuradha Marla• Lea Helena Strother

Statistical programming• Niels Højsgaard Jørgensen• Gertrud Dam-Dalgeir• Allan Lyngby Lassen

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Welcome

Business Management• Ann Helene Jenfort• Eva Sellberg Felthaus• Mads Bo Christensen• Trevor Jozef Piatkiewicz

China• Bettina Twile• Chen Dong

Clinical Support Services: • Jeanne Steffensen• Birgitte Pryds • Sóley Seyer • Nina Amirrezvani

CTS• Michael Steenhed• Mette Bak Dissing• Thomas Møller

Process Management• Lotte Rosendal• Mengqi Wang

RDA• Sara Linnet Skelbæk• Lisa Rahbek• Zorica Zecevic• Sara Rewers• Karina Sabroe

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WelcomeTrial Execution

CPM

• Amy Bowen• Anders Enok Olsen• Anders Bacher Nielson• Hanne Børgesen• Karina Nymark• Maria Wriedt Pedersen• Thomas Coquelle

CRA

• Imene Amdouni• Christine Ashby• Karine Brideau• Ncheta Momah-Okonkwo

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Our mission

October 1, 20177

Our mission

October 1, 20177

The Past

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Global Clinical Operations2012 – Marginal Gains

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Global Clinical Operations2012 – Marginal Gains Deliver

…And a Vuelta

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Global Clinical OperationsWhat have we helped deliver

3 Phase III Programs

• IM-LTA

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Global Clinical Operations2012 – 2017 An Evolution

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The Present

12

2017 – Building Value for LEO AK Portfolio Highlights

Ingenol disoxate (Experity)

• LPLV achieved for 3 out of the 4 pivotal phase III trials. Last LPLV is scheduled this month

• DBL achieved 18 September for 1194

• Highly beneficial cross-departmental learnings have been achieved in the LPLV and DBL phase of these trials

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2017 – Building Value for LEOAtopic Dermatitis Portfolio Highlights

JT• pre-IND recognise CHE as indication

Protopic• Extensive oversight monitoring has been performed and analysed for

APPLES

Tralokinumab• Global Phase III is up and running

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2017 – Building Value for LEOChina Highlights

R&D Hub• Established!

Daivobet• China trial 1079 LSFV acheived

Fucicort• FCF-38 protocol finalished• Selected our Vendor

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2017 – Building Value for LEO Early Portfolio Key Results Highlights

LP0133 - Topical JAK PoCs

• 1180 Hand eczema - Nov ‘16

• 1182 Psoriasis in sensitive areas – Jan ‘17

• 1222 Alopecia areata - Feb 2017

LP0058 – PDE4 for oral treatment of Pso

• 1072 PoC - Sep ‘17

• 1362 Japan bridging trial delivered - Sep ‘17

EXP-1223

• Acne Vulgaris PoC delivered - June ‘17

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2017 – Building Value for LEOJapan Highlights

Japan

• A pipeline in Japan!

• Dovobet gel: Submission, inspection and queries as flawless as can be

• Tralokinumab first global study with Japan and Korea included

• Enstilar for Japan: Program approved

• PDE4 oral - coming Japan’s way with a little luck

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2017 – Building Value for LEO Psoriasis Portfolio Highlights

Enstilar

• Rapid Recruitment into1004

• Project team Kick-off meeting for Enstilar Japan 15 September

• Adolescence trial1108 has completed recruitment to the main study

Kyntheum

• Successful oral hearing Jan 2017

• Approval and launched in EU

• LP0160-1327 Ready to go

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2017 – Building Value for LEO Business Management Highlights

• Resource model in place for all key skill types

• Implementation of governance model for trial changes

• Establishment of one point of truth GCO Dashboards

• Establishment and implementation of Global Clinical Partnerships

• Successful implementation of efficient P2P (Procure to Pay) process

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2017 – Building Value for LEO Process Highlights

Audit• 27 audits and 1 DE facility Inspection• No critical findings

Biometrics• Study Composer for CRF standards implemented• Standards: CRF standard v.1.0 in review • LEO 2nd in clinical data transparency• Pinnacle21 data validation tool implementation

eITF• pilot kicked off in May • 27 sites in Canada & Australia

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2017 – Building Value for LEO Process Highlights

eMap• Went live 1 Feb ‘17 • 200+ user’s• 30-40% less pages in SOP/WI’s• 26 documents made obsolete

eTMF• Creation of eTMF• Go-live January ‘17

Project Baseball• Repack of 600 archiving boxes

◦ - 47 pallets = to 25 Protopic studies..

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The Future

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Where-to-play Stop, continue, start decisions

Sto

pC

on

tin

ue

Sta

rt

• Exit emollients and not enter into aesthetics

• Not drive Rx to OTC in EU and US (established OTC portfolio continues)

• Discontinue margin diluting patient solutions in specific markets

• Not drive product innovation LCM in the established portfolio for EU and US

• Focus our digital efforts on improving patient-prescriber-payer interaction

• Continue to invest in innohep®

• Perform targeted geographical expansions

• Accelerate and perform LCM in our Established portfolio for Region International

• Ensure critical mass in the Established portfolio

• Accelerate expansion in the area of innovative solutions in US, EU, Japan

• Expand in to high unmet need and rare indications

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We are one LEO with two portfoliosESTABLISHED PORTFOLIO INNOVATIVE PORTFOLIO

• Backbone of LEO Pharma

• Expand scale and scope in targeted

areas

• Measure on sales and profitability

• “Biotech” growth

• Focus on unmet medical needs and

rare diseases

• Measure on pipeline progress and

value

tralokinumabPDE4

PDE-4

JAKi

24

Significantly higher R&D investment

= higher expectations25

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Moved to line of

business

Moved to line of

business

Strategic projects have been prioritized for 2017/2018

Excel in

understanding

patients and

ecosystem

Develop

differentiated

go-to-market

models

Drive efficiency

and

optimisation

Transform R&D

to deliver

innovation

Strategic projects/programmes running in 2017/2018

Establish seamless and agile supply chain

Simplify fundamental business processes

Drive different models in regions and markets (Models to target broader group of doctors)

Deliver inorganic growth and optimise LCM-model for Region International

Launch tralokinumab in the US and key markets successfully

Transform R&D (Unparalleled disease understanding, Rare diseases, US R&D platform)

Engage and enable LEO people to help SARAH (Develop leaders and talent, Attract talent)

Strengthen business decisions by market intelligence and patient insights

Accelerate innovative business through BD

1

3

2

4

5

6

7

Note: Project names are work-in-progress and will be made more suitable for communication

Drive stakeholder advocacy to prioritise

dermatology

Realise R&D efficiencies

Perform targeted geographical

expansions in Region International

Establish a culture where we obsess over

patients and their ecosystem

PProjects to be initiated beyond

2017/18

Capture growth in China

Note: Projects sequenced to run after 2017/18 due to

evaluation of potential value and investment, and project

dependencies

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LEO Pharma will move dermatology– and R&D continues to be key

We are dedicated to

medical

dermatology

Our R&D mind set drives success

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Then and Now

Risk PotentialTime-to-market

CATCH Phase IIIb 2014

Picato® - Phase IIIb 2013

Daivobet® Ointment, Japan 2015

LEO 29102, AD 2017

Applicators, US 2013

Sprays, US 2015

Pipeline 2011

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LEO Pharma will move dermatology– and R&D continues to be key

We are dedicated to

medical

dermatology

We understand

patients and their

ecosystem better

than anyone elseOur R&D mind set drives success

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Innovation events based in GCO p. 030

• 2,690 visitors in the pop-up

• 135 testimonials

• 657 portraits by Rankin and his assistants

• 1,128 pictures for the digital census

• 13 patient organisations involved

• 3,192 users to the NY:SKIN website

NY:SKINA few numbers

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LEO Innovation Booth – at AAD2017A few numbers

• 138 visitors in the booth

• 17 meaningful engagements

• 258,516 reach/impressions on social media

• 853 social media interactions (likes, shares, comments)

• 4 patient organisations involved

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LEO Innovation Booth – at EADV2017EADV2017: A few numbers

• 1,300 visitors in the booth

• 17kg of sweets consumed

• Approximately 550 cups of coffee served

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LEO Pharma will move dermatology– and R&D continues to be key

We are dedicated to

medical

dermatology

We understand

patients and their

ecosystem better

than anyone else

We are an attractive

partner and a

unique place to

work

Our R&D mind set drives success

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The new LEO Voice

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Yearly survey

~50 questions

Mini survey

~10 questions

Mini survey

~10 questions

The new LEO Voice Focus on having on-going team conversations that matter

The 1-2-3 principle

Team conversations

1 Issue

2 Actions

3 Follow-ups

Team conversations

Team conversations

1 October, 2017

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The 1-2-3 principle

1 issueWhen the results are available, our team has a meeting where we

discuss the results and identify 1 issue that we want to work with until

the next survey.

2 actionsAt the same meeting, we identify 2 actions to address the issue and

we define roles and responsibilities.

3 follow-upsWe follow up 3 times on our actions during our existing team

meetings.

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And Finally, A quote

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Rocket: "So, we're savingthe galaxy again?"

Peter Quill: "Yep."

Rocket: "Awesome! We'rereally going to be able to jack up our price if we'retwo-time galaxy savers."

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Global Clinical Operations 2017Where Teamwork Matters

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