1 © 2021 CEPHEID1 © 2021 CEPHEID

Kristians Korns

kristians.korns@cepheid.com18/06/2021

Improving and rationalizingmaintenance and care of GeneXpert devices in EECA region

2 © 2021 CEPHEID

• GeneXpert 10 Color technology technical aspects

• Cepheid Covid package proposal to C19RM additional funding from GF

• Service and maintenance AccessCare program

• Trade-in project

• Product pipeline

Summary

3 © 2021 CEPHEID3 © 2021 CEPHEID

GeneXpert® Systems10-Color technology

May not be available in all countries. Not available in the United States.

4 © 2021 CEPHEID

GeneXpert® System comparison

6-Color GeneXpert System 10-Color GeneXpert System

Specific catalogue number

Product registration Complete Pending for few countries only

Computer Operating System Win XP, 7, 10 Win 7,Win 10

GeneXpert Dx Software GX DX 4.4a to 6.4 Software versions 1 GX DX 6.2 and higher Software versions

Differentiation Grey module doors Blue lip on the module's doors

Capabilities 6 Color detection 6+4 Color detection

Test compatibility Can run Cepheid current test menu except Xpert

MTB/XDR* test

Can run all current and future Cepheid test menu

Xpert Check From GX DX 5.3 Software → v 1.5 v 1.5

* CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries. Not available in the United States.

• 1 Win XP Gx.Dx Software from 4.3 to 5.3

5 © 2021 CEPHEID

• The 10-Color GeneXpert® Systems met the WHO prequalification acceptance

criteria to be run with several tests.

• The public reports are available at the following location:https://extranet.who.int/pqweb/vitro-diagnostics/prequalification-reports/whopr.

• The 10-Color GeneXpert Systems is now available in the GDF Catalogue

Last updates

* CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.

6 © 2021 CEPHEID

Procurement options

* CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.

10-Color Multiplexing Technology

3 options

- check computer Windowsversion

- Software upgrade might beneeded.

New 10-Color modules in

replacement of the existing

6-Color modules

1

- check computer Windowsversion

- Software upgrade might beneeded.

New 10-Color Satellite

instrument in complement of

an existing 6-Color

GeneXpert® System

2

New 10-Color GeneXpert

System

3

7 © 2021 CEPHEID

• An add-on GeneXpert Instrument connected to an existing GeneXpert® System.

• The Daisy Kit allows connection of 2 instruments to a same computer

Definition of Satellite instrument

GeneXpert

Existing GeneXpert System

GeneXpert

Add-on 10-C Satellite Instrument

8 © 2021 CEPHEID8 © 2021 CEPHEID

Cepheid Global Access

May 2021

HBDC COVID Packages

May not be available in all countries. Not available in the United States.

9 © 2021 CEPHEID

Background

• There is a need for the specific Response Mechanism to mitigate the impact of COVID-19 onprograms to fight against TB, HIV and malaria, and initiate urgent improvements in health andcommunity systems.

• All countries, including regional/multi-country recipients, that are currently receiving funding fromThe Global Fund, are eligible to receive C19RM funding 1.

• The Global Fund recently received supplemental funding from different donors(reaching US$ 3.7 billion) to pursue efforts around:

COVID-19 Response

COVID-19 related adaptation of programs to fight HIV, Tuberculosis, Malaria

Strengthening health and community systems

1 The Global Fund.2021 https://www.theglobalfund.org/en/covid-19/health-product-supply/diagnostics-procurement/

10 © 2021 CEPHEID

Immediate response from Cepheid

• Supports the response to COVID-19 and impact on other diseases (Tuberculosis)

‒ New HBDC offers of COVID packages :

‒ New 10 Color GeneXpert® Systems associated with customized packages of Xpert® Xpress SARS-CoV-2 offered at more accessible pricing.

‒ Offers with or without Xpert MTB/RIF® Ultra tests*

‒ No price distinction in packages between Laptop and Desktop

‒ Each package is available under a Cepheid Part Number

‒ Valid until December 2022 **

*CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries. Not available in the United States.

** Validity period may be subject to changes

11 © 2021 CEPHEID

Conditions for Eligibility

• Eligibility

‒ All HBDC eligible customers can benefit from it

‒ Local funding

‒ The Global Fund - Application for additional funding via TGF website, free text zone in Wambo

• Not applicable

‒ GeneXpert® 6 Color Systems not available in these offers

‒ Xpert® MTB/RIF* Assay not available in these offers

* CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.

12 © 2021 CEPHEID

Offers

Catalogue Numbers Name System Xpert Xpress SARS-CoV-2

tests

Xpert MTB/RIF Ultra tests Price USD $

PCK-COV-100-L Pack COV GX4 Laptop 1 GX IV-4-L-10C 100 0 US $ 15,800

PCK-COV-100-D Pack COV GX4 Desktop 1 GX IV-4-D-10C 100 0 US $ 15,800

PCK-COV-400-L Pack COV GX16 Laptop 1 GX XVI-16-L-10C 400 0 US $ 59,530

PCK-COV-400-D Pack COV GX16 Desktop 1 GX XVI-16-D-10C 400 0 US $ 59,530

PCK-COVMTB-120-L Pack COV-MTB GX4 Laptop 1 GX IV-4-L-10C 120 100 US $ 17,000

PCK-COVMTB-120-D Pack COV-MTB GX4 Desktop 1 GX IV-4-D-10C 120 100 US $ 17,000

PCK-COVMTB-500-L Pack COV-MTB GX16 Laptop 1 GX XVI-16-L-10C 500 500 US $ 64,350

PCK-COVMTB-500-D Pack COV-MTB GX16 Desktop 1 GX XVI-16-D-10C 500 500 US $ 64,350

13 © 2021 CEPHEID13 © 2021 CEPHEID

Cepheid Service & MaintenanceAccessCare Program

14 © 2021 CEPHEID

What difference?

• A new way to finance service coverage:

A surcharge (1~2$) over the cartridge price to include full

service coverage

• All inclusive, entire installed base in the country covered

• Support performance monitored and shared:

Contractual Service Level Agreement (SLA) aiming at

providing the best support for the entire covering period

At which price?

• Variable: based on the size of Installed Base and number

of Cartridges to be ordered during the year (< 2$)

AccessCare : a New Support Option for HBDC* Countries

A comprehensive and enhanced Service & Maintenance program since January 2019

*HBDC : high burden developing country

**HyperCare is a transition phase proactively replacing failed modules ahead of AccessCare implementation

HyperCare

Warranty period

1 year Renewable

Warranty extension

Billable service HyperCare **

AccessCare

Promoting heterogeneous testing: service is paid by everyone

Instruments can be used by TB, HIV or HPV programs

15 © 2021 CEPHEID

• Additional budget for service, several

contracts

• Flexibility on warranty extension

without service delivery commitment

• Significant waste in instruments -

Modules down → lost capacity

(suspicion 20+%)

Benefits Over Traditional Support

• Only one contract/vendor covering the

entire installed base and finance through a

surcharge on cartridges (all-inclusive)

• Travel and accommodation included

• Service delivery performance guaranteed

by a Service Level Agreement

• Continuous monitoring of support

• Key Performance Indicators shared with

stakeholders to enable continuous

improvement

From Extended Warranty To AccessCare

Result oriented · Best performances

16 © 2021 CEPHEID

Metrics success and testimonies

Overall AccessCare improved

testing and cartridge consumption,

and the GeneXpert utilization rate

increased from 66% to 77% in only

two quarters.”

Notes from Uganda TB Stakeholders Meeting

“

17 © 2021 CEPHEID

AccessCare Snapshot

AccessCare Program is implemented in 8 countries

5 key metrics from Service level Agreement are

monitored and shared every month with stakeholders

Module availability

Percentage of Modules that are up and running

Timely module replacement

Percentage of module swaps that were timely

Timely part replacement

Percentage of other repairs and replacements that

were timely

Timely preventive maintenance

Percentage of preventive maintenance that were timely

Timely response time

Percentage of requests that received a timely response

Key metrics provides customers visibility

on Cepheid actions, performance and continues

improvements

KenyaEthiopiaUganda

MalawiZambiaZimbabwe

Nigeria

Pakistan

18 © 2021 CEPHEID18 © 2021 CEPHEID

Trade-in program

19 © 2021 CEPHEID

TRADE-IN Perimeter & Conditions

Conditions• Only Applies to Systems Older than 7 years AND IF the testing capacity (qty of modules) is maintained or increased

• Customer can chose to order a new 6C or 10C GeneXpert, including 2 years of warranty

• New systems come with all regular parts

• Non Cumulative option (return of 2 x GX-4 to purchase 1 GX XVI is excluded)

• Old system to be returned or at minima, all old modules MUST BE collected back by Cepheid

• No change in items Part Numbers

• Traded units would be deleted from the Installed base

• No direct special impact on Access Care

✓The TRADE IN Program globally consists of a discount % for the purchase of new GeneXpert®

II, IV or XVI, in exchange of the return of a new GX® older than 7 years

✓Opportunity for existing GX® owners to maintain/upgrade their installed base

✓Cepheid will insure proper disposal of the old system

20 © 2021 CEPHEID20 © 2021 CEPHEID

Pipeline CE-IVD

21 © 2021 CEPHEID

RespiratoryHAI & Other

Infectious Diseases

Blood Virology, Women’s

Health, & Sexual Health

TB & Emerging Infectious

Diseases

Oncology &

Human Genetics

Xpress SARS-CoV-

2/Flu/RSV

Xpress SARS-CoV-2

Xpress Flu/RSV

Xpress Strep A

MRSA NxG

SA Nasal CompleteMRSA/SA Blood Culture

MRSA/SA SSTICarba-R

Norovirus

EnterovirusC. difficile

vanA/vanB

Group B Strep

Chlamydia

Chlamydia/GonorrheaTrichomonas

HPV

ResistancePlus MG FleXible#

Hepatitis B VL

Hepatitis C VL

Hepatitis C Fingerstick

HIV-1 Qual

HIV-1 VL

MTB/RIF Ultra

MTB/XDR

Ebola

BCR-ABL Ultra

Thrombophilia (FII & FV)

Bladder Cancer Detection

Bladder Cancer Monitor

Breast Cancer STRAT4

Respiratory Panel

Bordetella FleXible#

Omni SARS-CoV-2

GI Panel

CMV FleXible#

Xpress Chlamydia/Gonorrhea

Xpress Multiplex Vaginal Panel

Xpress Group B StrepHIV-1 Qual XC HIV-1 VL XC

Omni MTB/RIF Ultra

Tropical Fever Panel

Hemorrhagic Fever Panel

BCR-ABL Ultra p190

AML (NPM1)

Omni SARS-CoV-2/Flu/RSV

Pneumocystis FleXible#

Carba-R NxG

Candida auris

CNS Viral Panel

ResistancePlus NG FleXible#

Sexual Lesions Panel FleXible#

Omni HIV Qual XC

Omni HPV

TB Fingerstick

MTB/RIF/INH

Breast Cancer

Lung Cancer Panel

AML (IDH1/2)

AML (FLT3)

* CE-IVD. In Vitro Diagnostic Medical Device. Not available in all countries. Visit cepheid.com for more details.

^ Products in development. Not for use in diagnostic procedures. Not reviewed by any regulatory body. Products in development are subject to change and target menu is subject to revision.

# FleXible Cartridge program in partnership with selected Trusted Reagent Manufacturers and not included in product count.

AML: acute myeloid leukemia, CMV: cytomegalovirus, CNS: central nervous system, GI: gastrointestinal, HAI: healthcare-associated infections, HPV: human papillomavirus, INH: isoniazid, LB: Lim Broth, MG: Mycoplasma genitalium, MTB: Mycobacterium tuberculosis,

NG: Neisseria gonorrhoeae, Qual: qualitative, RIF: rifampin, XDR: extensively drug-resistant SA: Staphylococcus aureus, SSTI: skin and soft tissue, VL: viral load, XC: extended coverage

Expanding on the Best-in-Class MDx Menu – CE-IVD

Tests

Available Now*

Launches

2021–22^

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13

Launches

2023–24^

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