ceo agm presentation 14 december 2018 - genera...
TRANSCRIPT
Mr. Richard Hannebery
Chief Executive Officer1
CEO AGM Presentation
14 December 2018
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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.
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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)
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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)
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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
Corporate Snapshot
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Complex microfluidic cartridge systems Great multiplex but incredibly expensive !
Microfluidic Instruments relatively simple, however consumable tests are highly complex (and expensive)
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‘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
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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
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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
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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)
Corporate Snapshot
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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%+)
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“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
Corporate Snapshot
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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
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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
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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
Corporate Snapshot
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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
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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
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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
$3,440
$1,985
$552
$744$152$120
$136
$88$72
$720
US
Europe
Japan
China
Brazil
India
Russia
South Korea
Mexico
RoW
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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
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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
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-
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
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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
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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
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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 !
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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+)
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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
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Visit us at www.generabiosystems.com
Thank You
Corporate Snapshot
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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
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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
Corporate Snapshot
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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
Corporate Snapshot
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Global KOLs are getting behind the power of complete HPV Genotyping