69
SCIENT’X SAS DECEMBER 31, 2013 Vice President EMEA Raoul Bernhardt Supply Chain Director Jean-Luc Ranson Human Resources Director Béatrice Machu Demand & Planning Mgr Etienne Herbet Supplier Relations Mgr Blaindine Bouvet Customer Service Mgr Gwénaëlle Target Quality & Regulatory Affairs Director Arnaud Destainville Process Validation Mgr Sebastien Guette Quality Systems Mgr Cathy Bocahut Vice President Finance EMEA Jean Yves Henry Group Account Director Anouk Pointier Cost Control Manager Stephanie Petit Legal Manager Franck Fasquel Business Support Sr Mgr Patricia Taillefer Custumer Service Coordinator Annick Maldat IT Manager Yannick Philippe COO and President International, Alphatec Holdings W. Patrick Ryan Market Mgr France & UK Julie Plano Coordinator, Clinical Studies Sabina Champain Specialist, International Products Loic Leleu Area Sales Manager North of France Christophe Besnard Manager, Marketing Support Marie-Laure Deleplanque Vice President Sales and Marketing France & UK Edouard Goetgheluck Manager, Group Products Sophie Molinier

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Page 1: Master sample deck

SCIENT’X SAS DECEMBER 31, 2013Vice President

EMEARaoul Bernhardt

Supply Chain DirectorJean-Luc Ranson

Human Resources Director

Béatrice Machu

Demand & Planning MgrEtienne Herbet

Supplier Relations MgrBlaindine Bouvet

Customer Service MgrGwénaëlle Target

Quality & Regulatory Affairs Director

Arnaud Destainville

Process Validation MgrSebastien Guette

Quality Systems Mgr Cathy Bocahut

Vice President Finance EMEA

Jean Yves Henry

Group Account DirectorAnouk Pointier

Cost Control Manager Stephanie Petit

Legal ManagerFranck Fasquel

Business Support Sr MgrPatricia Taillefer

Custumer Service Coordinator

Annick Maldat

IT ManagerYannick Philippe

COO and President International,

Alphatec HoldingsW. Patrick Ryan

Market Mgr France & UKJulie Plano

Coordinator, Clinical Studies

Sabina Champain

Specialist, International Products

Loic Leleu

Area Sales Manager North of France

Christophe Besnard

Manager,Marketing Support

Marie-Laure Deleplanque

Vice President Sales and Marketing France & UKEdouard Goetgheluck

Manager,Group ProductsSophie Molinier

Page 2: Master sample deck

SUPPLY CHAINVice President

EMEARaoul Bernhardt

Supply Chain DirectorJean-Luc Ranson

Executive Assistant GMSandrine

Boussemart

Demand & Planning MgrEtienne Herbet

Continuous ImprovementCoord.

Dorine Kochalski

Procurement AgentElisabeth Wintrebert

FinisherDominique Courtin

Finishing OperatorClément Delboe

CNC Screw MachinistBruno Plouviez

CNC screw machinistRémy Vincent

CNC Screw MachinistOlivier Orru

CNC screw machinistClément Thon

Distribution & Set Admin Supervisor

Ludovic Payen

Maintenance technicianRaynold Cliquet

Team LeaderRémy Nicoulaud

Procurement AgentPauline Bouhourdin

Procurement AgentStéphanie Pascual

Picking AgentCyril Desavis

Set Admin SupervisorStéphanie Nicoulaud

Picking AgentAnthony Lebas

Receptionist Logistic Agent

Cédric Cornee

Expedition LogisticAssistant

Fabien Lefebvre

Set ProcessorWilliam Demoulin

Set administratorJérôme Sudol

Set ProcessorIsabelle Boulet

Page 3: Master sample deck

The ’309 Patent

3JTX 002, Fig. 1

Page 4: Master sample deck

The ’309 Patent

4JTX 002, Fig. 1

Page 5: Master sample deck

Lotronex’s Market Share

5

All patients with

severe IBS

Patients taking

LotronexMost of the

prescriptions for

Lotronex come

from a small

number of

physicians

Option 1

Page 6: Master sample deck

Lotronex Has Failed to Meet Sales Expectation

6 Source: Boghigian Rep. ¶ 57-¶ 59

$0

$50

$100

$150

$200

$250

$300

$350

2007 2008 2009 2010 2011 2012 2013 2014

Actual Sales Expected Sales Downside Management Upside

Dollars in Millions

Page 7: Master sample deck

What Is a Royalty?

House Landlord Rent

Patent Licensor License Royalty

Renter

Licensee

Intellectual Property

Lease

Agreement

Agreement

Real Property

7

Page 8: Master sample deck

Investigation

Calculations

Testing3

2

1

Summary of Approach

8

Confirm Opinions

Check Conclusions for

Reasonableness

Consider Expert Opinions

Fact Finding

Key Issues

Reasonable Royalty on

Recent Sales

Reasonable Royalty on

All Sales

Lost Royalties

Page 9: Master sample deck

9

0

250

500

750

1,000

1,250

1,500

1,750

2,000

Product

Infringing Sales

Infringing Sales Caused Product Sales To Plummet

Product

drops 80%

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

Page 10: Master sample deck

$0.90

$1.10

$1.30

$1.50

$1.70

$1.90

$2.10

$2.30

Q42008

Q12009

Q22009

Q32009

Q42009

Q12010

Q22010

Q32010

Q42010

Q12011

Q22011

Q32011

Q42011

Plaintiffs Suffered Price Erosion

10

Product Price If No Copy

Product Actual Price

Price Erosion

Page 11: Master sample deck

$0.00

$0.50

$1.00

$1.50

$2.00

How To Bridge the Gap Between the Parties

11

Royalties

Without any overlap

in the parties’

bargaining positions,

no deal can be reached

THE GAP

Plaintiffs can

accept no less than

$1.80 in royalties

Defendants can pay

no more than

$1.27 in royalties

Page 12: Master sample deck

Updating the Market Share

12

14%

16%

18%

20%

Plaintiff

Forecasts

Defense

Expert’s Update

0%

18.7%

18.3%

17.2%

15.5%

14.7%

16.4%

17.4%

2008 2009 2010 2011

Market Share

Exaggeration

Page 13: Master sample deck

Updating Plaintiff’s Sales Forecasts

13

500

550

600

650

700

750

800

850

2008 2008 2009 2009 2010 2010

Plaintiff’s Expert’s Projection:

2.1654 Billion

500

550

600

650

700

750

800

850

2008 2009 2010

Difference: 132.5 Million

Keep this general

layout but change the

scale and the data

while keeping similar

lines. Change years.

Page 14: Master sample deck

What Problems Does the ’598 Patent Address?

14

• Not all POIs are equally important:

• For example, the Grand Opera House might be of interest to a regional audience.

• But local businesses like “Quiznos Sandwich” and “Brew Haha!” might be of interest to a more local audience.

Page 15: Master sample deck

’598 PatentDistributed Network of Data

Storage Devices

How Does The ’598 Patent Address

These Problems?

15

Centralized Data Storage

??

??

? ?? ? ? ?

ii

ii

i ii i i i

??

??

? ?? ? ? ?

ii

ii

i ii i i i

Page 16: Master sample deck

Distributed Network of Data Storage Devices

16Source: ’598 PatentDistributed Network

• The ’598 Patent is directed at the storage and retrieval of location-based information in a distributed network of data storage devices

Data Storage Devices

Page 17: Master sample deck

Claim 1 – Accessible Simultaneously

17

…accessible simultaneously from a plurality of remote user terminals…

Distributed Network of Data Storage Devices

ii

iii i

i i i i?

???

? ?? ? ? ?

Page 18: Master sample deck

Google Maps Divides the World into

Map Tiles at Various Zoom Levels

18

…data defining a plurality of first localities in relation to which information storage is accessible;

• Each map tile at every zoom level corresponds to a first locality.

• Google Maps defines map tiles at each zoom level with Cartesian coordinates.

Tiles in Google Maps are numbered from the same origin as that for pixels, so that the origin tile is always at the northwest corner of the map. Tiles are indexed using x,y coordinates from that origin. For example, at zoom level 2, when the earth is divided up into 16 tiles, each tile can be referenced by a unique x,y pair:

Page 19: Master sample deck

19

…data defining a plurality of first localities in relation to which information storage is accessible;

Google Maps Divides the World into

Map Tiles at Various Zoom Levels

Zoom Level 3

Zoom Level

1 Zoom Level

0

• Each zoom level contains tiles representing the entire World.

Zoom Level

2

1 Tile4 Tiles

16 Tiles

64 Tiles

0,00,0 1,0

1,10,1

0,0 1,0

1,10,1

2,0 3,0

3,12,1

0,2 1,2

1,30,3

2,2 3,2

3,32,3

0,0 1,0

1,10,1

2,0 3,0

3,12,1

0,2 1,2

1,30,3

2,2 3,2

3,32,3

0,4 1,4

1,50,5

2,4 3,4

3,52,5

0,6 1,6

1,70,7

2,6 3,6

3,72,7

4,0 5,0

5,14,1

6,0 7,0

7,16,1

4,2 5,2

5,34,3

6,2 7,2

7,36,3

4,4 5,4

5,54,5

6,4 7,4

7,56,5

4,6 5,6

5,74,7

6,6 7,6

7,76,7

Page 20: Master sample deck

© DecisionQuest 2014 Confidential & Privileged Attorney Work Product

2%

5%

2%

6%

16%

28%

42%

21%

38%

40%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

James White

Alexander Trevor

Extremely Quite Somewhat A little bit Not at all

Nervous

Page 21: Master sample deck

© DecisionQuest 2014 Confidential & Privileged Attorney Work Product

30%

9%

53%

53%

12%

14%

5%

12% 12%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

James White

Alexander Trevor

Extremely Quite Somewhat A little bit Not at all

Knowledgeable

Page 22: Master sample deck

© DecisionQuest 2014 Confidential & Privileged Attorney Work Product

26%

21%

32%

23%

30%

33%

12%

14% 9%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

James White

Alexander Trevor

Extremely Quite Somewhat A little bit Not at all

Easy to Understand

Page 23: Master sample deck

© DecisionQuest 2014 Confidential & Privileged Attorney Work Product

9%

7%

19%

21%

28%

72%

44%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

James White

Alexander Trevor

Extremely Quite Somewhat A little bit Not at all

Evasive

Page 24: Master sample deck

Approved Treatments for PAH

24

BID, twice daily; ERA, endothelin receptor antagonist; ET, endothelin; IV, intravenous; LFT, liver function test; PAH, pulmonary artery hypertension; PDE-5i, phosphodiesterase-5

inhibitor; QD, once daily; SC, subcutaneous; TID, three times daily. Hoeper MM et al. J Am Coll Cardiol. 2009;54:S85-S96; Simonneau G et al. J Am Coll Cardiol. 2009;54:S43-S54.

Drug Dosing Launch yr NotesP

rost

acyc

lin a

nal

og

s

Flolan (epoprostenol) IV: 2ng/kg/mL, titrated to max 1995 “Gold standard”; Ice packs; headache

Remodulin (treprostinil) SC/IV 2002/04 Site pain, diarrhea, headache

Ventavis (iloprost) Inhaled: 6-9×/day 2005Bayer/Actelion; chest pain, nausea

Time/inhalation

Tyvaso (treprostinil) Inhaled: 4×/day 2009 + delivery syst; headache

Veletri (epoprostenol) IV: 2ng/kg/mL, titrated to max 2010 Room temperature stable

ER

A Tracleer (bosentan) Oral BID: 62.5, 125mg 2001Diarrhea, liver tox,

monthly LFT

Letairis (ambrisentan) Oral QD: 5, 10mg 2007 Selective ETA ; liver tox

PD

E-5

i Revatio (sildenafil) Oral TID: 20mg (also IV) 2005/09 3 doses/day; headaches

Adcirca (tadalafil) Oral QD: 40mg 2009 1 dose/day; headaches, myalgia

For internal use only. Not to be copy or distributed.

4.1

Page 25: Master sample deck

Distribution of PAH Therapy Utilization

25

0

20

40

60

80

100Initial Therapy Therapy Adjustment at 1st Follow-up*

ERA PDE-5i ERA PA PDE-5i CCB

Pat

ient

s on

PA

H O

ral T

hera

pies

(%

)

* Total is greater than

100% since some

patients are on

multiple agents.

n=251

n=455

n=306

n=56

n=533

n=147

CCB, calcium channel blocker; ERA, endothelin receptor antagonist; PA, prostacyclin analog; PAH, pulmonary arterial hypertension; PDE-5i, phosphodiesterase-5 inhibitor.

Angalakuditi M et al. J Med Econ. 2010;13:393-402.

Pat

ient

s (%

)

Retrospective claims database analysis of 706 patients with PAH enrolled in a large,

geographically diverse US managed-care organization

For internal use only. Not to be copy or distributed.

0

20

40

60

80

100

4.1

Page 26: Master sample deck

Substantial Gains With Treatment:

Median Survival Times Have Lengthened

0%

20%

40%

60%

80%

100%

0 1 2 3 4 5 6 7

Su

rviv

al

Years of follow-up

NIH registry (1981-1985)

REVEAL registry (2001-2009)

26

Median survival

2.8 years

Median survival

expected to be

>7 years

NIH, US National Institutes of Health; REVEAL, Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management. D’Alonzo GE et

al. Ann Intern Med. 1991;115:343-349. Benza RL et al. CHEST. 2012;142:448-456.

For internal use only. Not to be copy or distributed.

4.1

Page 27: Master sample deck

ESC/ERS Guidelines: Assessment

and Monitoring Recommendations

• Suggested assessments and timing for follow-up of PAH patients,

ESC/ERS guidelines

For internal use only. Not to be copy or distributed.27

At baseline

(prior to

therapy)

Every 3-6

months*

3-6 months after

initiation or changes

in therapy

In case of clinical

worsening

Clinical assessment WHO-

FC ECG

6MWD†

Cardiopulmonary

exercise testing†

BNP/NT-proBNP

Echocardiography

Right heart catheterization ‡

§

§

6MWD, 6-minute walk distance; BNP/NT-proBNP, brain natriuretic peptide/N-terminal prohormone of BNP; ECG, electrocardiograph; ERS, European Respiratory Society;

ESC, European Society of Cardiology; FC, functional class; PAH, pulmonary arterial hypertension; WHO, World Health Organization. Eur Resp J. 2009;34:1219-63.

4.1

Include footnote to

explain superscripts

Page 28: Master sample deck

Diuretics

• Diuretics are used to treat fluid retention

(edema) due to PH because duiresis will

diminsh hepatic congestion and

peripheral edema

• Should be used with caution to avoid

decreased cardiac output (due to

decreased right and/or left ventricular

preload), arrythmias produced by

hypokalemia, and metabolic alkalosis

Galie. Eur Heart J. 2009;30:2493-537.

4.2

Page 29: Master sample deck

Anti-coagulation

• Patients with PH are at increased risk

for intrapulmonary thrombosis and

thromboembolism due to

• Sluggish pulmonary blood flow

• Dilated right heart chambers

• Venous stasis

• Sedentary lifestyle

• Even a small thrombus can produce

hemodynamic deterioration in a

patient with a compromised vascular

bed that is ubable to dilate or recruit

unused vasculature

Barst. JACC. 2009;54:S78-84. Galie. EHJ. 2009;20:2493.

4.2

Page 30: Master sample deck

Inhalation with Iloprost: Case Report

CO

SaO2

PAP

CO

(l/m

in)

SaO

2(%

)

PA

P (

mm

Hg

)

5

100

90

9060300

40

75

3

Iloprost Inhalation

Minutes

Olschewski. Ann Int Med. 1996;124:820-4.

4.3

Page 31: Master sample deck

Bosentan 125 mg (n = 74)

-40

-20

0

20

40

60

80

Bosentan 250 mg (n = 70)

Placebo (n = 69)

Baseline Week 4 Week 8 Week 16

62.5 mg/bid 125 or 250 mg/bid

6-M

WT

(m

)

Mean ± SEM

BREATHE-1 Results: Change in 6MWD

Rubin. NEJM. 2002;346:896-203.

54 meters

35 meters

No Dose

Response at

250mg

despite these

6MWD

4.4

Page 32: Master sample deck

5 mg2.5 mg 5 mg 10 mg

* *

0

20

40

60

ARIES 1

(n=201)

ARIES 2

(n=192)

31m

51m

32m

59m

Combined 5mg group = 45m

ARIES-1 and 2 Results: 6MWD

Galie. Circulation. 2008;117:3010-9.

Letairis Prescribing Information. Gilead Sciences. 2011.

5mg and 10mg

approved

4.4

Page 33: Master sample deck

PDE-5 Inhibition

For internal use only. Not to be copy or distributed.33

GMP

cGMP

Vasorelaxation and antiremodeling

NO

GTPPKG

↑cGMP

PDE-1, 2

PDE-6, 9, 10,

11

PDE-5

sGC

eNOS

4.5

PDE-5

inhibitors

Page 34: Master sample deck

STEP-1: Bosentan + Iloprost or Placebo

Change in 6 MWD and Time to Clinical Worsening

-75

-50

-25

0

25

50

75

Baseline Week 4 Week 8 Week 12

Ch

an

ge

fro

m b

as

elin

e in

6 M

WD

0

0.2

0.4

0.6

0.8

1

0 14 28 42 56 70 84

Time in days

Pro

po

rtio

n f

ree

of

clin

ica

l w

ors

en

ing

McLaughlin V, et al. Am J Respir Crit Care Med 2006;174:1257-1263.

Iloprost

Placebo

6 MWD Clinical worsening

Placebo adjusted difference: + 26 m

(P=0.051)

(P=0.022)

32

32

31

31

31

28

31

27

31

27

21

18

Iloprost, N=

Placebo, N=

Page 35: Master sample deck

35

ABOUT 80% OF THE SPINAL IMPLANT MARKET

IS IN THE UNITED STATES

Page 36: Master sample deck

36

France

D E F E N D A N T

Surgiview

OrthoTec

P L A I N T I F F

Page 37: Master sample deck

SPINAL IMPLANT PRODUCTS

37

Page 38: Master sample deck

38

FUSION PRODUCTS

SCS Claris Cerfix

Page 39: Master sample deck

39

EUROSURGICAL IS NEAR THE COURT OF ARRAS

PARIS:Surgiview

BEAURAINS:Eurosurgical

ARRAS:Court

F R A N C E

Page 40: Master sample deck

40

July 22, 2004

French Court appoints Meynetas Administrator

Aug 6, 2004

Meynet meets with Bertranou

Sep 16, 2004

Meynet recommends two-year lease

Sep 29, 2004

French Court approves two-year lease to Surgiview

Oct 11, 2004

Surgiview signs distribution agreement with Scient’x

July 1, 2005

Scient’x buys 74% of Surgiview

May 3, 2006

French Court appoints Meynet as conciliator

Oct 20, 2006

French Court approves

Surgiview’spurchase of

Eurosurgicalassets not owned

by OrthoTec

2004 2005 2006

Page 41: Master sample deck

41

Welcome

Johanna Shulman

Global Brand Director

Signifor (pasireotide)

Page 42: Master sample deck

42

ACTH-independent Cushing’s Syndrome(20% of cases)

ACTH-independent Cushing’s syndrome (20% of cases)

• Cortisol is overproduced because of an abnormality on the adrenal glands

ACTH-dependent Cushing’s syndrome (80% of cases)

• Ectopic: Extra-pituitary ACTH-secreting tumor

• Cushing’s disease: ACTH-secreting pituitary tumor- High ACTH in turn produces

increased cortisol

- Deregulation of the HPA feedback loop

Arnaldi G et al. J Clin Endocrinol Metab. 2003 Dec;88(12):5593–602. Review

Page 43: Master sample deck

43

Cushing’s SyndromeDiagnostic Algorithm

Nieman LK et al. J Clin Endocrinol Metab. 2008 May;93(5):1526–40.

Perform 1 of the following tests

24 hour UFC (≥2 tests)

Overnight 1 mg DST

Late night salivary cortisol (≥2 tests)

48 hour 2 mg DST in certain cases

Patients with suspected Cushing’s syndrome

without exposure to exogenous glucocorticoids

NormalDiscrepant Abnormal

Cushing’s syndromeAdditional evaluation CS unlikely

CS

unlikely

Normal

Abnormal

Exclude physiologic causes of hypercortisolism

Consult endocrinologist

Perfrom 1 or 2 of the studies above (or repeat studies)

Perform Dex-CHR or midnight serum cortisol in certain cases

Page 44: Master sample deck

44

Differential Diagnosis of Cushing’s Disease

Nieman LK et al. J Clin Endocrinol Metab. 2008 May;93(5):1526–40 .

Cushing’s syndrome

Perform CRH

stimulation testMeasure plasma ACTH

ACTH independent

Cushing‘s syndrome

Perform pituitary

MRI Perform adrenal CT

or MRI

Perform bilateral inferior

petrosal sinus sampling

Cushing’s disease

Search for ectopic

ACTH source

Search for ectopic

ACTH source

Abnormal

Normal/

equivocal

Normal/

equivocal

High

Low

Positive

Negative

Normal/

equivocal

Positive

Page 45: Master sample deck

45

Treatment of Cushing’s Disease

The treatment goals in Cushing’s disease are

Reversal of clinical features

Normalization of biochemical changes with minimal morbidity

Long-term control without recurrence

Biller BMK et al. J Clin Endocrinol Metab. 2008;93:2454-2462.

Page 46: Master sample deck

46

Symptoms noticed• Weight gain• Don’t feel well• Easily fatigued• Mood changes

Patient’s Journey: An Overview

Seek medical advice, treated for HTN, diabetes, osteoporosis, depression, ADHD, and other

symptoms

PCP

Endo

Other specialist

Patient most likely to get to Endo if:• Has diabetes, especially if hard

to control• Weight gain questions • Patient self-refers

Endo conducts tests• Other testing done

(eg, thyroid) before get to CD detection

If early testing equivocal:• May be repeated• Other tests (eg, salivary cortisol)

may be conducted• MD may rule out CD• Patient may seek other MD

ACTH serumtesting

Imaging of pituitary

TSS 1st choice—potentially “cure”• If tumor confirmed surgery

within 3-6 months

Normalized cortisol levels:

• “Cure”

• Monitor over time

Cortisol levels remain above normal; patient continues to have symptoms; recurrence: No good options at present• Meds (toxicity, lack efficacy)• 2nd pituitary surgery • Radiotherapy• BLA

May take 5+ yrs to get to Endo Diagnosis process can take 1+ yrs Treatment

24 hr UFC

Dex suppression

Page 47: Master sample deck

47

Patient’s Frustrations and Societal Withdrawal Were Poignantly Illustrated Within Their Journals

Hig

h p

oin

tsP

ain

po

ints

Pre-diagnosis Diagnosis process Initial treatment Later treatment

Surgery was to = Cure, feeling as bad or worse

than before surgery

– Fatigue– Weight gain– Muscle weakness– Pain

Fatigue, other pre-surgery symptoms may take time to

dissipate

Diagnostics a hassle, intrusive, must live with fatigue, other physical symptoms

It could be Cushing’s—at last, possible

answer

Surgery could be “Cure”

Gaining weight, fatigued, pain, restless, but not sure what is wrong

Bonding with Endo important during

this time

Potentially return to more normal social

interactions

“I don’t want to live like this the rest of my life” –

From patient interview, US

Page 48: Master sample deck

48

Treatment Options Are Limited - No “ideal” Option, No Clear Protocol After the First TSS

TSS 1st Line Tx Cortisol levels remain above normal

• Patient continues to have symptoms

Monitor over time

Medical Therapy-Not that effective

- Serious SEs

Bilateral adrenalectomy

- Drastic- Patient on meds for life

- Can create other problems (eg, Nelson’s syndrome)

Radiotherapy- Takes time to determine effect

- Can cause broader damage

2nd pituitary surgery-Less effective

- Creates other hormonal problems

If chemical remission,lingering patient symptoms essentially ignored—should

“go away” eventually

Biochemical remission:• “Cure”

Tumor recurs

Page 49: Master sample deck

49

At Month 6, the Majority of Patients Had a Reduction From Baseline in UFC

Patient

mU

FC

(nm

ol/24 h

)

0

500

1000

1500

2000

4000

7000

Pasireotide 600 µg bid Pasireotide 900 µg bidBaseline mean UFC Month 6 mean UFC Month 6 responder*

Change in UFC at month 6 in the 103 patients with baseline and month 6 UFC measurements

Sorting is by baseline mean UFC value

The reference line is the upper limit of normal, UFC, which is 145 nmol/24 h

Page 50: Master sample deck

50

0 10 20 30 40 50 60

>ULN to ≤2xULN

>2xULN to ≤5xULN

>5xULN to ≤10xULN

>10xULN

Patients achieving UFC ≤ULN (%)

Pasireotide 900 μg bid (N=80)

n=11

n=20

n=9

n=28

n=13

n=41

n=26

n=40

n=66

n=12

n=14n=26

Primary Efficacy EndpointSubgroup Analysis at 6 Months

Pasireotide 600 μg bid (N=82)Overall (N=162)

Page 51: Master sample deck

51

Shifts in Response Status From 6 to 12 Months

N=36(22.2%)

N=20(55.6%)

N=3(8.3%)

N=13(36.1%)

N=25(15.4%)

N=5(20.0%)

N=8(32.0%)

N=12(48.0%)

N=101(62.4%)

N=6(5.9%)

N=4(4.0%)

N=91(90.1%)

• Controlled

• Partially controlled

• Uncontrolled

Page 52: Master sample deck

52

Signifor VisionTo be the backbone of therapy for the treatment of pituitary and gastroenteropancreaticneuroendocrine tumors, the definitive agent to show total disease control of tumor AND symptoms

Signifor Positioned for Superior Disease Control

Signifor Positioning*

Clearly Define the “Signifor” Patient• Surg/Rx failure• When tumor is not

localized• While waiting for

surgery

SI1Clearly Articulate the Benefits of Signifor Tx• Biochemical control• Tumor control• “Pituitary-directed”• “Pituitary-sparing”

SI2Differentiate From SomatostatinAnalogs & Other Tx• MOA, rational design• Clinical efficacy• Value proposition• Broad range of

pituitary tumors

SI3

Increase Clinical Experience• Expanded GMA

program• Expanded

development program

• Rapid completion of all registration studies

Implement Life Cycle Management to Maximize Brand Value• LAR studies• New indications• Explore other

formulations

SI5

For pituitary-treating endocrinologists, Signifor is the first multi receptor targeted somatostatin analogue

that offers superior disease control in multiple pituitary tumors

SI14

Vision and Positioning statements are aspirational and are not necessarily reflective of current labels – often will include developing clinical data* Placeholder, MR on final positioning ongoing

Page 53: Master sample deck

53

Cushing’s Disease: Market Overview and Trends

Positive growth drivers

• High unmet medical need

• % of patients without localized tumors

Key negative growth factors

• Ketoconazole:low price, oral

• Dopamine agonists:low price, oral

Treatment of Cushing’s Disease–2009

Shares are approximate based on estimates from market research regarding 1st line treatments

Adrenalectomy 1%

Radiation

4%

Medical Therapy

25%

Successful Surgery

70%

Mitotane/

Metyrapone 7%

Ketoconazole

18%

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54 54

2010 2011

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Reg

istra

tion

Mark

et R

ead

iness

Bra

nd

Stra

teg

y a

nd

C

PO

Read

iness

Countdown to Cushing’s Disease LaunchGlobal Activities At-a-Glance

CPO Education Kits Cushing’s disease slide

kits Strategic planning

SDP Sep

FIR 12m: May

CDBL May

LPLV Mar

Cushing’s Disease Ph III

Oct EU Submission

May US Submission

Early Access Pgm

Promotional Support (Unbranded, Web, Convention, PASPORT) Launch Materials (Vis Aid, Branding Guidelines, Convention)

CPO Planning Kits Launch planning Forecast model

and training

Cushing’s Disease Ph III – LAR

PR Materials

PackagingValue Dossier Approved

Price CD Launch

Scientific Communications – Clinical, Economic, MA – Pubs, Abstr, Symposia

Health Economics Burden of illness Cost of sub-optimal therapy Cushing’s QoL validation

Investigator Mtgs, Ad Bd

Patient Roundtable

CPO Launch Readiness

Market Research Rx drivers Forecast model KOL mapping Positioning & messaging

Branding Global brand strategy Global launch plan Trade name Branding elements

EU Go-To-Launch

Mtg

PRE Go-To-Launch

Mtg (1)

PRE Go-To-Launch

Mtg (2)

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55

Cushing’s Regulatory Strategy Is Moving ForwardGlobal Submission Strategy Based on 12 Months Data From B2305

EU

• Submission: Oct 2010 / submit results from 2nd TQT study with day 120 LoQ

• Approval: Dec 2011

US

• Submission: May 2011 (FDA unlikely to consider 2nd TQT study during review)

• Approval: Nov 2011 (assuming Priority Review)

Switzerland

• Submission: Dec 2010 / Submission of 2nd TQT during review accepted by HA

• Approval: Jun 2011 (assuming Fast Track)

ROW

• Submissions planned with exception of Japan (Japan participates in Cushing’s LAR program)

• Prioritization and roll out in discussion with CPOs

Page 56: Master sample deck

56

Market Research Timelines: Positioning Research Has Begun

2010 2011

Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

Positioning Development

and Testing

Core Message & Prelaunch Concept Development and

Testing

Launch Concept Development and Testing

Sales Aid Development and Testing

Pre Go-To-

Launch Meeting

EU &

CH

Subm

US Subm

Global materials

Ready

Go-to-

Launch

Meeting

US App

EU App

Cushing’s Disease

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57

Announce Cushing’s Data and Regulatory MilestonesPR to Educate Media and Prepare for Successful Launch in 2010

Prepare internal and external spokespeople

Develop launch PR toolkit

JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

European Congress of Endocrinology (ECE)

Prague, Czech Republic24-28 April

The Endocrine Society (ENDO) San Diego, CA

19-22 June

FDA File Acceptance

Swiss Approval(Up-side scenario)

ECE data press release

Science writer’s workshop onsite

Leverage first approval as global milestone

Press release and top tier media outreach

ENDO press release

One-on-one media interviews with medical experts

Leverage US and EU positive milestones

Press release and top-tier media outreach

EMEA Positive Opinion

Prepare press releases, Q&As, support materials across milestones; consider social media opportunities to expand reach

Coordinate with country communicators to engage and maximize opportunities

FIR

Dec EMEA Submission

FDA Submission

Waiting for Updated Data 2010-2011 Timeline

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58

Signifor Launch Training Plan

Endocrine A&P

AugQ1 Sept Oct Nov DecJulyQ2Q4

SOM230 Objection Handler

SOM230 Go-To-Launch

Meeting

Understanding Cushing's Disease

Management of Cushing's Disease

Pasireotide

SOM230 Go-To-Launch Prework

Live Preceptorship Kit

Patient Case Series Flashcard

20

10

Kic

k O

ff

Disease Awareness Objection Handler

Cx Assessments

Patient Case Series FlashcardsDisease State, Diagnosis

Representative Launch Training

ASM Coaching Guide

Annotated Clinical Reprint

Print-based

Competitive Flashcards

Page 59: Master sample deck

59

B2305 2010 Publication Timelines

Somatostatin

Receptor complexity

ACTIVITY MAR 10 APR 10 MAY 10 JUN 10 JUL 10 AUG 10 SEPT 10 OCT 10 NOV 10 DEC 10

ABSTRACTS

MANUSCRIPTS

ICE B2305 study design

poster

ENDO B2305 UFC variability

poster

ENEA B2305 oral presentation

Sept 23

B2305 ENEA abstract submission

(post deadline)

ECE, ENDO, & IPS 2011

abstract initiation

12-month data manuscript

UFC variability manuscript

Submission (JCEM)

Submission (NEJM)

Page 60: Master sample deck

60

B2305 2010 Key Activities

Somatostatin

Receptor complexity

ACTIVITY MAR 10 APR 10 MAY 10 JUN 10 JUL 10 AUG 10 SEPT 10 OCT 10 NOV 10 DEC 10

DATA

MILESTONES

CONGRESSES

INVESTIGATOR

ACTIVITY

SATELLITE

SYMPOSIA

& CONGRESS

EVENTS

INTERNAL

MEETINGS

Draft CSR available

DB lock

12-month

data availableFIR

Region Europe/Italy Round Table

ENDO 19-22 Jun

San Diego, CA

ENEA 22-25 Sept

Liege, Belgium

ICE satellite

symposium

ECE satellite

symposium

Novartisevening event

(ENDO)

ENEA B2305 internal

newsflash

ENEA satellite symposium

Sept 23

ENDO poster author

discussion Apr 24

Steering committee & investigator

meeting Jun 17

ENDO poster author

discussion May 27

Global marketing strategy meeting

Communication taskforce (PR, marketing, Sci Com)

Face-to-face publication

planning meeting

Page 61: Master sample deck

Conspiracy period

Plea period

61

0

20

40

60

80

100

120

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Pri

ce in

dex (

Jan

1996 =

100)

Large TFT panel actual price index

But-for price index (conspiracy period)

But-for price index (plea period)

But-for price index for the dynamic prediction model – large panels

What Happened Here?

Page 62: Master sample deck

What Happened Here?

62

Conspiracy period

Plea period

0

20

40

60

80

100

120

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Pri

ce in

dex (

Jan

1996 =

100)

Large TFT panel actual price index

But-for price index (conspiracy period)

But-for price index (plea period)

But-for price index for the dynamic prediction model – large panels

Page 63: Master sample deck

What Happened Here?

63

Conspiracy period

Plea period

0

20

40

60

80

100

120

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Pri

ce in

dex (

Jan

1996 =

100)

Large TFT panel actual price index

But-for price index (conspiracy period)

But-for price index (plea period)

But-for price index for the dynamic prediction model – large panels

Page 64: Master sample deck

What’s the Product at Issue?

64

Page 65: Master sample deck

What’s the Product at Issue?

65

Top Front Cover With Glass

Speaker

LCD

Top Back Cover

Bottom Front Cover

With Key Pad

Key Pad Controller

Circuit Board

Microphone

Bottom Back Cover

Microprocessor

Page 66: Master sample deck

What’s the Product at Issue?

66

Fluorescent Lights

Glass Plate

Electrodes

Liquid Crystal

Electrodes

Light Filter

Glass Plate

Page 67: Master sample deck

Defendants Operated in the U.S.

67

Taiwan

Korea

Japan

United States

Chunghwa

SDI

Page 68: Master sample deck

Motorola’s Single Global Price

68

SDI

Chunghwa

Page 69: Master sample deck

Conspiracy period

Plea period

69

But-for price index for the dynamic prediction model – small panels

0

20

40

60

80

100

120

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Pri

ce

in

de

x (

Jan

19

96

= 1

00

)

Small TFT panel actual price index

But-for price index (conspiracy period)

But-for price index (plea period)