1 © Cepheid© 2013 Cepheid1

GeneXpert ® Procurement Stakeholder Meeting

• 28 Oct. 2013, Institut Pasteur Paris

2 © Cepheid2

• The Xpert® MTB/RIF 50-test Pack

• Calibration with Xpert Cal

• Proposals for Extended Warranty on GX-IV and XVI

• Developing Expertise within Programs

• Remote monitoring

• HBDC facts

• Xpert ® menu

Table of Contents

3 © Cepheid© Cepheid

1) The Xpert ® MTB/RIF 50-test Pack

4 © Cepheid

50 Test Xpert ® MTB/RIF Pack

• Now available

• Item Reference CGXMTB/RIF-50 – May require complementary registration in some countries

• Reduced packaging and volume– Lower shipping costs

– More efficient use of storage space

Objective: Stop production of the 10 cartridge presentation during 2014

5 © Cepheid5

50 Test Xpert ® MTB/RIF Pack

• 5 Pouches of 10 cartridges‒Once opened, pouch stability

‒ 6 weeks @ 2 - 45 °C / 75%RH

‒ i.e. minimum throughput of 1 test every 4 days

‒Other components packaged in bulk

‒ One box of 50 x 8ml sample reagent bottles

‒ 5 packs of 12 x 2ml pipettes

• Pack Storage conditions unchanged

• 50 Cartridge Pack price

‒ $499 (50 x $9.98)

*All Prices Ex Works, Prepaid

6 © Cepheid© Cepheid

2) Calibration with Xpert ® Cal

7 © Cepheid7

Xpert ® Calibration: Kit Packaging

Empty Data CD

Software,Package Insert

XpertCal kit for GX IV - 4

8 © Cepheid

Xpert ® Cal

• Optical system is adjusted

‒ Dye Mix with Lot Specific Parameters

‒ 100% Optical Signal is re-established

‒ Applies a channel specific correction factor

• Verification of the Thermal System

‒ One synthetic template

‒ 3 Melt Probes

‒ 3 Target temperatures

• Module sub-system functionality

‒ Valve drive performance

‒ Heater and fan performance

‒ Syringe drive performance

‒ Force sensor performance

- Ultrasonic Horn performance- Power Supply performance- Electronic component performance- Historic data that verifies module

performance is also captured- No patient data is collected

9 © Cepheid9

Xpert ® Cal - Process

Code

activates the

modules�

New

certificate

Code

activates the

modules�

New

certificate

Customer

receives

Xpert

Calibration

Kit

Customer

receives

Xpert

Calibration

Kit

Customer

Runs Xpert

Calibration

Kit

Customer

Runs Xpert

Calibration

Kit

Customer

Sends Data

to Cepheid

Customer

Sends Data

to Cepheid

Data is

analysed,

activation

code is sent

to Customer

Data is

analysed,

activation

code is sent

to Customer

Customer

Receives a

Code

Customer

Receives a

Code

Online – via InternetOr Offline – on supplied CD-R

10 © Cepheid© Cepheid

3) Proposal for Extended Warrantyon GX IV and XVI

11 © Cepheid11

• Focus on NEW 3 year warranty extension

- Prepayment at system purchase or during the initial warranty� Sustainability� Donors/Programs Long term strategy

Presumes that the trained end user « actively cooperates » (changing a module, etc )

Reminder: Impossibility to standardize and include local specific expenses (taxes, customs, travel and lodging expenses, salaries, etc…) . This has to be agreed country by country.

• Possibility to conclude national agreements with Cepheid and or partners, for a broader coverage (including additional services or local expenses … )

• Computer exchange proposed after 5 years

Extended Warranty – Cepheid/FIND negotiated

12 © Cepheid

3 Years of warranty extension, GX IV 4

Ref. for aGX IV 4

Comments &Conditions

HBDC Offer

3 Years warranty

Saving

3 X GX4-4-12M

(includes 3 X 1 prev. maintenance)

today(3 X $2,900) $8,700 -

All Prices Ex Works, Prepaid / Items references to be confirmed.

Ref. for a

GX IV 4

Conditions HBDC Offer

3 Years warranty

Saving

GX4-4-36P(includes 3 Prev. maintenance)

Payment in advance

within 2 years of

instrument purchase

$7,900 $ 800

Ref. for a

GX IV 4

Conditions HBDC Offer

3 Years warranty

Saving

GX4-4-36S(includes 3 Prev. maintenance)

Payment in advance at

the time of instrument

purchase

$6,850 $ 1,850

13 © Cepheid – Confidential.

HBDC all inclusive acquisition of a GX IV 4(5 year warranty)

Items 2 Years+

3 x 1 Year

2 Years+ 3 Years

paid in advanceduring the 2 1st years

5 Yearspaid in advance

at systempurchase

GXIV-4 D $17,000 $17,000 $17,000

Xpert Cal. 1 kit $450 $450 $450

Total System + 2 Years Warranty

$17,450 $17,450

3 years extd. Warranty $ 8,700(3 x $2,900)

$ 7,900 $ 6,850

Total System + 5 years Warranty

$26,150 $25,350 $24,300

Saving - $ 800 $1,850

All Prices Ex Works, Prepaid / Items references to be confirmed.

14 © Cepheid

3 Years of warranty extension, GX XVI 16

Ref. for aGX XVI 16

Comments &Conditions

HBDC Offer

3 Years warranty

Saving

3 X GX16-16-12M

(includes 3 X prev. maintenance)

From now(3 X $7,800) $23,400 -

All Prices Ex Works, Prepaid / Items references to be confirmed.

Ref. for a

GX XVI 16

Conditions HBDC Offer

3 Years warranty

Saving

GX16-16-36P(includes 3 X prev. maintenance)

Payment in advance

within 2 years of

instrument purchase

$20,900 $2,500

Ref. for a

GX XVI 16

Conditions HBDC Offer

3 Years warranty

Saving

GX16-16-36S(includes 3 X prev. maintenance)

Payment in advance at

the time of instrument

purchase

$18,500 $4,900

1 Year Service contract lowered from $9,300 to $7,800

15 © Cepheid – Confidential.

HBDC all inclusive acquisition of a GX XVI 16(5 year warranty)

Items 2 Years+

3 x 1 Year

2 Years+ 3 Years

paid in advanceduring the 2 1st

years

5 Yearspaid in advance

at systempurchase

GXXVI-16-D $71,000 $71,000 $71,000

Xpert Cal. 4 kits $ 1,800 $ 1,800 $ 1,800

Total System + 2 Years Warranty

$72,800 $72,800

3 Years extd. Warranty $23,400(3 x $7,800)

$20,900 $ 18,500

Total System + 5 years Warranty

$96,200 $93,700 $91,300

Saving - $2,500 $4,900

All Prices Ex Works, Prepaid / Items references to be confirmed.

1 Year Service contract lowered from $9,300 to $7,800

16 © Cepheid© Cepheid

4) Developping Expertise withinPrograms

17 © Cepheid17

Invest in Team/ Staff Education

In a large programmes – it may be helpful to create an internal training academy‒Retain and enhance knowledge within the programme

‒Communicate in local language

‒ Include training on programme-specific procedures

‒ In larger programmes a pyramid of trained people will allow competence to be maintainedat peripheral testing sites

‒Cepheid can indeed help and be part of the implementation

18 © Cepheid18

• Cepheid « Regular training » program for users (2 day training, session every month)

• Cepheid « Advanced training » program for program coordinators & Cepheid Authorized Service Providers (3 day training, session every month)

• Cepheid web based training for users and Authorized Service Providers. (1 hour per day during 5 days, available on demand, online)

• Next steps: E-learning, self-training computer based, …

Training

19 © Cepheid19

• Installation

• Pre Assessment: Electricity/UPS/Lab equipment/controlled environment…

• Need to involve:- Local Cepheid team in place or local Cepheid partner- Customer : initial training materials provided and free

web based training available in different languages (English /Spanish/Russian/French)

• Training� The more practice the better

• Develop in-country competences: pyramidal transmission of knowledge

• From this pool of USERS: identification of some key users (already trained or existing users)

• Cepheid training team in cooperation with the National Program to set up different Super Users training 5/ 6 months after system is installed:.

• Super Users, as specialists monitoring the program, will then go locally and train/help other users

Roll-out of National Programs/ Large programs

20 © Cepheid© Cepheid

5) Remote Monitoring

21 © Cepheid

Xpert ® MTB/RIF Some Roll-Out Issues in HBDC Countries

• How to monitor system usage

• How many tests are being performed?

• Identify system, modules or user training issues

22 © Cepheid

Pilot Package (tested by NHLS & FIND India today, 1M+ test results)

• Functionalities‒Geographical Disease Trending

‒ Error trending per GX operator and module

‒ Aggregate reports per region

‒ Export test results to Excel

‒Control reporting for each GeneXpert system

‒User access rights

• Infrastructure‒ Pilot reporter on the GX

‒ Pilot RUO web site

Sept 2013: 1,000,000 test results

23 © Cepheid

GeneXpert ® Monitoring Requirements HBDC

Robust platform

Protect sensitive

data

Control access

Share data with

others

Merge with other relevant

data

Integrate with other

apps

View, analyze

24 © Cepheid

RemoteXpert ® HBDC Launch - Q2 2014

• Improved Pilot functionalities‒ Improved web app (historical trending, better browsing & filtering)

‒ Extended data set reported (full test result, errors, logs, status, …)

‒ Simplified installation and settings for the user + remote upgrade

‒Manage system replacement / relocation

• Added Functionalities‒ API for external applications

‒ Push document to GX system (user training)

‒ Share data with other institutions (full or summary level)

‒ Append data to test results (demographics, workflow)

• New Architecture‒ Integrated communication layer

‒Ruggedized Reporter and web application

‒ Private cloud hosting

25 © Cepheid© Cepheid

6) HBDC Facts

26 © Cepheid

Modules & Tests Volumes

Tests

0

200 000

400 000

600 000

800 000

1 000 000

1 200 000

MTB Tests / Quarter

0

500 000

1 000 000

1 500 000

2 000 000

2 500 000

3 000 000

3 500 000

4 000 000

4 500 000

0

2000

4000

6000

8000

10000

12000

HBDC Modules Installed base

HBDC Tests Cumulated

27 © Cepheid

3 Years of HBDC Implementation

Modules Q1 Q2 Q3 Q4 Total

2010 Pre HBDC 36 10 40 80 166

2011 358 157 760 960 2 235

2012 578 623 1 058 357 2 616

2013 1 164 1 372 2 072 4 608

Total 9 625

Tests Q1 Q2 Q3 Q4 Total

2010 Pre HBDC 13 500 820 4 280 22 190 40 790

2011 45 530 105 580 137 450 262 100 550 660

2012 272 340 243 540 375 220 409 420 1 300 520

2013 423 410 882 230 1 017 380 2 323 020

Total 4 214 990

28 © Cepheid© Cepheid

7) Xpert Menu

29 © Cepheid29

Reminder: Xpert ® Menu

• EXISTING

• MRSA Surveillance

• SA Nasal Complete

• C. diff/EPI

• VanA/B for VRE

• MRSA/SA SSTI

• EV

• Flu

• GBS

• CT

• CT/NG

• BCR‐ABL

• MRSA/SA BC

• MTB/RIF

• Factor II/V

• ANNOUNCED

STDs

• Trichomonas

• HPV (2014)

• HSV 1&2

• Molecular PAP

Virology

• HIV VL (2014)

• HIV Qual (2014)

• HCV VL (2015)

• HBV VL (2015)

+ Meningitis, Encephalitis

+ Oncology …

HBDC available assays in bold. Eligible countries to be defined.

30 © Cepheid

Visit us at www.cepheid.com

Thank You.