ceo agm presentation 14 december 2018 - genera...

31
Mr. Richard Hannebery Chief Executive Officer 1 CEO AGM Presentation 14 December 2018 1

Upload: others

Post on 08-Jun-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

Mr. Richard Hannebery

Chief Executive Officer1

CEO AGM Presentation

14 December 2018

1

Page 2: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

2

Forward Looking Statements

This presentation includes forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks

and important factors that may cause the actual results, performance or achievements to Genera to be materially different from the statements in this presentation.

Actual results could differ materially depending on factors such as the availability of resources, the results of clinical studies, the timing and effects of regulatory actions, the strength of competition and our ability to obtain or maintain patent or other proprietary intellectual property protection; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Genera is providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.

Page 3: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

3

Genera Corporate Summary

Capital Structure

ASX code: GBI

TSOI (undiluted for B Notes): 107.5m

Share price (at 30 June 2018): $0.16

Market capitalisation: $17.2m

Cash at 30 September 2018: $0.02m*

Operating cash burn (2018): ($1.16m)

Substantial Shareholders

Mr Graham Durbin: 11.5%

Mr Richard Hannebery (consolidated): 11.0%**

Dr John Raff (Founder of SPL): 7.5%**

* On going cash requirements for working capital provided by existing major shareholders on an as required basis. ~$485K due DEC 2018 from FY2018 R&D tax rebate

** Adjusted for Put/Call Option agreement that allows Richard Hannebery to acquire 1.67m shares in GBI from Dr Raff at $0.23 per share

Peak Enterprise

Value

~ $53m in

anticipation of IVD

partnering deal

US FDA

approves Roche

Cobas HPV for

front line

‘screening’

Current

Enterprise

Value

~ $28m

Beckman

Distribution deal

providing

significant

‘automation’

Board of Directors

Mr Lou Panaccio (Non-Exec Chairman)

Mr Richard Hannebery (CEO)

Dr Karl Poetter (CSO & Founder)

Mr Jim Kalokerinos (Non-Exec Director)

Page 4: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

4

Genera Summary Overview

Genera pedigree/heritage Walter & Eliza Hall Institute (the birthplace of Amgen’s 1st ever blockbuster product : CSF’s)

• Founded in 2002 >$33M invested to date (excludes R&D tax rebate capital recycling)

Our Tech is still very relevant and our multiplexing capability is still cutting edge with patent protection to 2028

• False start in 2010/11 required Genera to go back around the buoy and re-approach the go-to-market strategy to reinvigorate the equity investment proposition

• Since 2014 Genera has had to fund operations via debt funding and has done so in a capital light manner (Just $5M has funded Genera since mid-2013)

The single biggest weakness and fundamental flaw in Genera’s business model solely around access to a user friendly automatedinstrumentation platform capable to be rolled out/scaled into global markets

• May 2018 ‘game changing’ workflow/automation with Beckman Coulter platform

• Third party filter plate/centrifuge integration component has caused some months delay which in turn has delayed lodgement of Genera Prospectus to next week

• We are well positioned to finally do the multiplex Tech justice in terms of pathology customer adoption and monetisation

• Pathology go-to-market strategy will be driven/led by PapType® as the beach-head with other complementary assays falling in behind to maximise instrumentation capacity utilisation

Closest multiplexed MDx technology comparables to Genera AmpaSand® Tech are

Luminex Corp (NASDAQ:LMNX) and SeeGene Inc (KOSDAQ:096530)

Page 5: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

5

Genera Summary Overview

We develop and commercialise true single-well multiplexed high usage Molecular Diagnostics (MDx) - 12 to 20 targets per well is Genera’s sweet spot

2 CE-IVD multiplexed MDx tests in production, 2 additional tests in pipeline, with further planned menu expansion (>6 tests by 2020).

We are targeting a multi-billion $$$ market opportunity in MDx and now poised to execute

• Our Tech comparative advantage draws focus to emerging markets that are substantially under penetrated due to prohibitive US style pricing wants

• Price & Volume and the right IVD Co partner is key in opening up a significant market opportunity

• Direct revenue opportunity > US$100M per annum can create GBI market value > US$500 M

New business unit focus on Companion Diagnostic assay development

• AmpaSand® multiplex allows competitive positioning against Next Generation Sequencing approach that in many cases is over specified for what is actually required

• Recent key hires - Seong Chen (Corporate Development Director) and Dr Damian Pethica (CMO) to help drive this business opportunity

Page 6: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

Corporate Snapshot

6

Complex microfluidic cartridge systems Great multiplex but incredibly expensive !

Microfluidic Instruments relatively simple, however consumable tests are highly complex (and expensive)

Page 7: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

7

‘End-time’ PCR followed with Target analysis via Flow Cytomtery

facilitates high multiplex *

AmpaSand® = higher throughput, lower cost : 16 target panel example

Genera’s Multiplex technology can

detect (up to) 125 targets in a single

well of a PCR reaction plate

Real-Time PCR Multiplex is limited

to 4 targets in a single well of a PCR

reaction plate

4 targets

4 targets

4 targets

4 targets

16 targets

MDx

Competitor

96-well plate

Offerings

* The trade off for our > multiplex capability is > complexity of the required instrumentation running tests

Page 8: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

8

Prior to Beckman Coulter Automation Stranded Tech

Pre-automation Genera’s MDx testing platform was like a sizable high grade ore

deposit with no viable means of transport to port

Genera 2010

to 2018 Genera

now

Page 9: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

9

Genera now has single vendor big brother instrumentation support

Initial term is 2 years (non-exclusive) with option to renew for up to 5 years (mutual agreement)

Effective date of Distribution Agreement is August 2018

➢ Internal validation of automated i5/CytoFLEX system has commenced – low risk process as CytoFLEX already validated performance in > 10,000 PapType®clinical samples

Beckman Coulter Distribution Agreement - instrumentation solution and applications to targeted pathology customers

➢ Leverages existing Beckman pathology customer relationships

➢ Provides world class in-market support

➢ Trade shows and site demonstrations help drive adoption

Genera to add application 2 sales application specialists to leverage Beckman Coulter pathology customer ‘Rolodex’

Expansion into a number of significant new territories

Page 10: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

10

Multiple touch points with Danaher Corp

PALL CORP acquired

by Danaher in 2015

US$13.8B

XITOGEN acquired by

Danaher in 2014

US$100M

IDT acquired by

Danaher in 2018

undisclosed

i-Series internally

developed released

2017

Danaher is parent Co of Beckman Coulter (NYSE:DHR)

Page 11: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

Corporate Snapshot

11

US$2,000M

US$630M

US$1,600MUS$600M

US$2,470M

Infectious Diseases MDx Market Size (US$ Millions)

Sexually Transmitted Diseases (STIplex) HPV (PapType)

Blood Borne Diseases (BBVplex) Respiratory Infections (RTIplex)

Global Market

2016: US$ 7.3Bn

2022: US$ 12.3Bn

CAGR 11.3%

Melvin Bright, Global Molecular Diagnostic Market – Trends, Insights, and Forecasts (October, 2017);

360-Dx, 16Dec2016; Health Publishing and Services, 12Jul2017

Global HPV Market may grow 3-5X over coming years

MDx growth driven by increasing

demand for accurate infectious disease assays – emerging

markets, particularly BRIC experiencing stronger growth

(20%+)

Page 12: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

12

“I skate to where the puck is going to be, not where it has been.”

Wayne Gretzky

Full High Risk HPV Genotyping is where we head

Low cost, comprehensive HPV genotyping can be a billion dollar opportunity in China Alone

Page 13: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

Corporate Snapshot

13

The evolution of Cervical Cancer Dx

Conventional Pap 1927 to 1990s LBC PAP 1990s to 2016 HPV & LBC PAP 2003 to 2016

HPV 16 & 18 genotyping with pooled

result for other 2014+HPV with full High Risk

genotyping 2019+

Pooled result

of 14 High Risk

Types, Yes/No

answer

ThinPrep®

LBC HPV partial genotyping

LBC HPV full genotyping

Page 14: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

14

FDA News Release

FDA Approves Roche's HPV Test for First-Line Primary Screening for Cervical Cancer

For Immediate Release

Apr 25, 2014

ReleaseThe US Food and Drug Administration (FDA) has for the first time approved a human papilloma virus (HPV) test that can be used alone instead of the Pap test to screen for cervical cancer. Screening means having a test that looks for cancer or another disease in people who don’t have any symptoms. The test, called the cobas HPV test, examines a sample of cervical cells. It looks for 14 types of the virus, including types 16 and 18, which cause about 70% of all cervical cancers.

The cobas HPV test was first approved by the FDA in 2011 for use with a Pap test or as a follow-up to a Pap test, which examines cervical cells for changes that might become cervical cancer. The new approval expands the use of the cobas HPV test, allowing it to be used either with the Pap test or all by itself for the early detection of cervical cancer in women 25 and older.

The FDA recommendation says if the cobas HPV test detects HPV types 16 or 18, women should have another test called a colposcopy, which uses a device to illuminate and magnify the cervix so a doctor can find abnormal areas that could be cancers or pre-cancers. If the cobas HPV test detects one of the other 12 HPV types, women should have a Pap test to determine the need for a colposcopy. Women who test negative for all 14 types should repeat the test in 3 years.

HPV testing front line tick of approval

Page 15: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

15

Yes, it has taken a little longer than anticipated

Prof Jack Cuzick ‘Sitting on the borders between maths and cancer medicine’

Fellow of The Royal Society, CBE,

2017 Recipient of American

Cancer Society Medal of Honour

“I remember when we released the results of the trial people would ask me how long it would be

until front-line HPV testing was routine and I used to answer ‘2006’. I was only a decade out !

But finally, we’re getting there.”

Jack Cuzick on HPV testing replacing the pap Smear as the primary screening method for cervical cancer

Page 16: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

Corporate Snapshot

16

PapType® more future proofed than Gardasil 9

Merck’s Gardasil has evolved the HPV Vaccine,

similarly, more expansive genotyping is where

the market is headed for HPV testing

Gardasil (70%)Approved by FDA in 2006

Gardasil 9 (90%)Approved by FDA in 2014

HPV Types 6,11; 16 & 18 HPV Types 6,11; 16,18,31, 33,

45, 52 & 58

Reimbursement US$127.50Reimbursement US$175.03

GSK exits U.S.

market with its

HPV vaccine

CervarixOctober 24, 2016

Page 17: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

17

Fully specified typing is the end game

Roche pioneered simultaneous HPV genotyping for screening (limited with 2 HR types),

BD has upped the ante (7 HR types) toward the end game

Roche Cobas®

(~70%)

Approved by FDA in 2014

PapType®

(~99.0%)

ARTG & CE Marked only

7 High Risk Types and pooled

result Yes/No for other 7

Reimbursement US$47.76 x 2

for HR screening and reflex

genotyping of HPV 16 &18

BD Onclarity®

(~90%)

Approved by FDA in 2017

2 High Risk Types and pooled

result Yes/No for other 12

All High Risk Types individually

specified

Reimbursement currently same

as Roche Cobas however BD

likely to pursue > $$$ overtime :

health economics of broader

genotype information

~46K patient study~33K patient study commence

(~24K completed)

Clinical data generated on ~16K

patient samples to date

Gen 2.0 Gen 3.0 Gen 4.0

Potentially highest possible

payor reimbursement & well

positioned for ‘out-of-pocket’ full

reflex genotyping

Reflex Trojan horse for

screening

Page 18: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

18

PapType® : initially a reflexive test…

Play PapType® Videohttp://generabiosystems.com/videos/

…but clinical data suggests applicable for screening also !

Other 12 High Risk Types initial ‘low-hanging fruit’ for

PapTypeTM

QplotsTM reporting software

means that a single assay ‘run’

may produce information

required for both the screen &

the reflex test results !

Genera market research

suggests little consumer

push back at $75.00

‘Out-of-Pocket’ cost after

a woman has tested

+ve for an Oncogenic

HPV infection

Page 19: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

$3,440

$1,985

$552

$744$152$120

$136

$88$72

$720

US

Europe

Japan

China

Brazil

India

Russia

South Korea

Mexico

RoW

19

Genera Monetisation Path Open and Grow Emerging Markets

Estimated US$8.0 billion (2019)

MDx Market Size

by Region (US$M)

A 5.0% market capture of US$2.5Bn per annum revenue opportunity = US$125m annual revenue and a ~US$750M

Market Cap based upon 6.0X comp revenue multiples for MDx M&A activities

Genera’s Expansion

Plan

The stratetgy for market

expansion with Beckman

Coulter is :

1. Brazil and India

2. China

3. Europe and Rest of

Asia

4. USA PapType®

(separate partnership

TBD)

We believe that > halving $$$ price (eg

>0.5x) of MDx in emerging markets

testing volumes may grow ~ 3-5X

Substantial market share capture

[India, Brazil and China alone =

US$1.5 Bn pa opportunity]

Source: VisionGain 2015

Page 20: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

20

Price & Volume play Reversing the order of the go-to-market strategy

Genera’s cost effective multiplex technology can open up and grow MDx in emerging markets opportunity exponentially

>US$100M pa

direct revenue

opportunity

>US$25M

upfront &

royalties

>US$20M pa

direct revenue

opportunity

Page 21: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

21

-

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

HPV52

HPV16

HPV58

HPV68

HPV18

HPV51

HPV31

HPV39

HPV33

HPV66

HPV56

HPV35

HPV45

HPV59

HPV sub-type distribution of positive HPV infections

PapType® optimal screening for ChinaOne size does not fit all !

HPV 1662%

HPV 58 13%

HPV 52 10%

HPV 188%

HPV 334%

HPV 313%

HPV Type distribution responsible for Cervical Cancer

in China

…16/18 genotyping less suited to China market

Page 22: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

22

Beckman Coulter CytoFLEXTM and DxFLEXTM

dominate China Market

Existing strong market acceptance of CytoFLEX technology provides Genera additional comfort in pursuing

China opportunities

Genera’s aims to place >7 to 10 integrated systems in China market generating > $7m in test sales

over 18 to 24 months from launch

Page 23: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

23

Short-term focus on strengthening financial and sales/partnering execution capability

Potential PapType® out-licensing opportunity identified in US market with well credentialed MDx company focused on cancer screening

➢ Provides US market exclusivity where partner, manufactures, sells and reports HPV test results

➢ Preferred approach is direct equity investment (~10.0% to 15.0%) with Genera partial contribution to US clinical studies for FDA registration PapType® screening indication

Discussions placed on hold with potential strategic partners for China market with capability to support primary/second source manufacturing capability – we will revisit in 2019 post US successful partnering

➢ Partners focused on relevant Emerging Markets with focus on PapType®

➢ Genera would expect License Fees ~US$4.0 to US$5.0m with agreed transfer pricing and royalties

➢ Tech transfer of test manufacturing process post proprietary Scoresby manufacturing ‘value add’

Completion of partnering and capitalistion program Genera aims to fund

➢ Material test menu expansion;

➢ 2 sales application specialists to support Beckman instrumentation sales leads (#1 February, #2 June);

➢ New assay Development Technician and Program Manager also to be hired

➢ New Companion Diagnostic Test development programs

Page 24: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

24

PapType® [16-plex]

HPV testing –gold standard in

Cervical Cancer screening

>$1.0 Bn global market

opportunity

Uniquely positioned with ‘world

class’ clinical data (KOLs)

STI-plex [8-plex]

Core CT/NG tests drive core volume with

TV and MG (including macrolide

resistance testing)

>$2.0 Bn global market opportunity

Very attractive in Brazil

RTI-plex [16-plex]

Respiratory panel test

>US$600M global current

market opportunity

IVF genetic screening [25-plex]

currently dominated by NGS products

15-20% of IVF patients opt-in @ pricing

~$500-$1,000 per embryo

Pricing for comprehensive chromosomal

aneuploidies < $100 may drive market

growth

3 to 4 test menu helps utilise capacityHT system capable of > 140K tests pa

…our goal is a test menu of ~10 assays !

Page 25: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

25

Why Invest in Genera?

Revenues ready to scale

➢ Automation void now addressed – ‘capital light’

instrumentation roll-out

➢ Relationships in place for rapid expansion of

customer base

➢ PapType® License fee income may fund

significant test menu expansion

➢ Introduce sharp pricing while still maintain >

~65% GM

➢ 15 volume customers may deliver > $150m value

➢ Management writes cheques with real skin in the

game

Well positioned within MDx

➢ Large market for products

➢ Competitive products manufactured to high

standards – A1 TGA rating

➢ Support of global Key Opinion Leaders (KOL)

with PapType®

➢ Cost competitiveness and clinical value of

platform positions us well for new markets

➢ Intellectual Property well advanced with

comprehensive patents granted – all major

jurisdictions (2028+)

Page 26: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

26

Upcoming Newsflow next 12 months

Indicative Date Milestone

END Q1 2019 : Market launch of new i5 automation system with PapType ‘reflex’

END Q2 CY2019 : Licensing agreement for PapType® (US & Canada)

Q2 CY2019 : STIplex test launched on new i5 system

Q3 CY2019 : Licensing agreement for PapType® (China) and broader 2nd source IVD reagent manufacture

Q3 CY2019 : India market launch RUO

Q1 CY2020 : China market launch RUO

Q2 CY2020 : Brazil market launch RUO

END CY2019 1 to 2 Companion Diagnostic test development partnerships

Page 27: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

27

Visit us at www.generabiosystems.com

Thank You

Page 28: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

Corporate Snapshot

28

Genera TechnologyGenera Tests Sensitivity

Cytology > Mild

PreTect HPV-Proofer

Roche

CINtekp16

APTIMA

RealTime

BD

ViperCobas

HC2S

en

sit

ivit

y

1 - Specificity

1.0

0.9

0.8

0.7

0.8 0.6

0.4

0.2

0.0

Genera clinical

results show high

sensitivity,

comparable to other

high throughput, high

sensivity HPV tests on

the market.

PapType® without

genotype specific risk

Jack Cuzick, et al. (2014) Individual detection of 14 high risk human papilloma virus genotypes by

the PapType test for the prediction of high grade cervical lesions. JCV 60: 44-49.

Displays indicative threshold for

Meijer compliant HPV screening

assay

Page 29: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

29

Cytology > Mild

PreTect HPV-Proofer

Roche

CINtekp16

APTIMA

RealTime

BD

ViperCobas

HC2S

en

sit

ivit

y

Specificity

1.0

0.9

0.8

0.7

0.8 0.6

0.4

0.2

0.0

Genera clinical results show very

high specificity with little loss of

sensitivity, using the power of

complete High Risk HPV genotyping.

PapType® without

genotype specific risk

Genera TechnologyMultiplexing Can Increase Specificity

Jack Cuzick, et al. (2014) Individual detection of 14 high risk human papilloma virus genotypes by

the PapType test for the prediction of high grade cervical lesions. JCV 60: 44-49.

PapType® applying hierarchical

typing algorithm : Demonstrates the power of

complete genotyping for increased

specificity

Page 30: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

Corporate Snapshot

30

Dec 1st 2017 – the new algorithm

Cytology

~ 70%

sensitivity

Types 31, 33

should have

immediate

colposcopy

Acquisition

of different

high risk

HPV type

=

unnecessary

colposcopy

Approximately

9 to 13%

depending on

age of patient

Page 31: CEO AGM Presentation 14 December 2018 - Genera Biosystemsgenerabiosystems.com/wp-content/uploads/bsk-pdf...Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Melvin Bright,

Corporate Snapshot

31

Global KOLs are getting behind the power of complete HPV Genotyping