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

Transcription

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

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. 2

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) Board of Directors Mr Lou Panaccio (Non-Exec Chairman) Mr Richard Hannebery (CEO) Dr Karl Poetter (CSO & Founder) Mr Jim Kalokerinos (Non-Exec Director) Substantial Shareholders Peak Enterprise Value ~ $53m in anticipation of IVD partnering deal US FDA approves Roche Cobas HPV for front line screening Beckman Distribution deal providing significant automation Current Enterprise Value ~ $28m 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 3 ** 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

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 automated instrumentation 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) 4

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 5

6 Complex microfluidic cartridge systems Corporate Snapshot Great multiplex but incredibly expensive! Microfluidic Instruments relatively simple, however consumable tests are highly complex (and expensive) 6

7 AmpaSand = higher throughput, lower cost : 16 target panel example Real-Time PCR Multiplex is limited to 4 targets in a single well of a PCR reaction plate Genera s Multiplex technology can detect (up to) 125 targets in a single well of a PCR reaction plate 4 targets 4 targets 4 targets MDx Competitor 96-well plate Offerings 4 targets 16 targets End-time PCR followed with Target analysis via Flow Cytomtery facilitates high multiplex * * The trade off for our > multiplex capability is > complexity of the required instrumentation running tests 7

8 Prior to Beckman Coulter Automation Stranded Tech Genera 2010 to 2018 Genera now Pre-automation Genera s MDx testing platform was like a sizable high grade ore deposit with no viable means of transport to port 8

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 9

10 Multiple touch points with Danaher Corp i-series internally developed released 2017 XITOGEN acquired by Danaher in 2014 US$100M IDT acquired by Danaher in 2018 undisclosed PALL CORP acquired by Danaher in 2015 US$13.8B Danaher is parent Co of Beckman Coulter (NYSE:DHR) 10

11 Global HPV Market may grow 3-5X Corporate Snapshot over coming years MDx growth driven by increasing demand for accurate infectious disease assays emerging markets, particularly BRIC experiencing stronger growth (20%+) Infectious Diseases MDx Market Size (US$ Millions) US$600M US$2,470M US$1,600M US$2,000M US$630M Global Market 2016: US$ 7.3Bn 2022: US$ 12.3Bn CAGR 11.3% Sexually Transmitted Diseases (STIplex) Blood Borne Diseases (BBVplex) HPV (PapType) Respiratory Infections (RTIplex) Melvin Bright, Global Molecular Diagnostic Market Trends, Insights, and Forecasts (October, 2017); 360-Dx, 16Dec2016; Health Publishing and Services, 12Jul

12 Full High Risk HPV Genotyping is where we head I skate to where the puck is going to be, not where it has been. Wayne Gretzky Low cost, comprehensive HPV genotyping can be a billion dollar opportunity in China Alone 12

13 Corporate Snapshot The evolution of Cervical Cancer Dx Conventional Pap 1927 to 1990s LBC PAP 1990s to 2016 HPV & LBC PAP 2003 to 2016 ThinPrep Pooled result of 14 High Risk Types, Yes/No answer LBC HPV full genotyping HPV with full High Risk genotyping LBC HPV partial genotyping HPV 16 & 18 genotyping with pooled result for other

14 HPV testing front line tick of approval FDA News Release FDA Approves Roche's HPV Test for First-Line Primary Screening for Cervical Cancer For Immediate Release Apr 25, 2014 Release The 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. 14

15 Yes, it has taken a little longer than anticipated Prof Jack Cuzick Sitting on the borders between maths and cancer medicine 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 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 Fellow of The Royal Society, CBE, 2017 Recipient of American Cancer Society Medal of Honour 15

16 PapType more future proofed than Corporate Snapshot 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$ Reimbursement US$ GSK exits U.S. market with its HPV vaccine Cervarix October 24,

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 Gen 2.0 Gen 3.0 Gen 4.0 Roche Cobas (~70%) Approved by FDA in 2014 BD Onclarity (~90%) Approved by FDA in 2017 PapType (~99.0%) ARTG & CE Marked only 2 High Risk Types and pooled result Yes/No for other 12 7 High Risk Types and pooled result Yes/No for other 7 All High Risk Types individually specified ~46K patient study ~33K patient study commence (~24K completed) Clinical data generated on ~16K patient samples to date Reimbursement US$47.76 x 2 for HR screening and reflex genotyping of HPV 16 &18 Reimbursement currently same as Roche Cobas however BD likely to pursue > $$$ overtime : health economics of broader genotype information Potentially highest possible payor reimbursement & well positioned for out-of-pocket full reflex genotyping Reflex Trojan horse for screening 17

18 PapType : initially a reflexive test Other 12 High Risk Types initial low-hanging fruit for PapType TM 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 Play PapType Video Qplots TM reporting software means that a single assay run may produce information required for both the screen & the reflex test results! but clinical data suggests applicable for screening also! 18

19 Genera Monetisation Path Open and Grow Emerging Markets US Europe Japan China Brazil India Russia South Korea Mexico RoW $720 $72 Estimated US$8.0 billion (2019) MDx Market Size by Region (US$M) $88 $136 $120 $152 $3,440 $744 Source: VisionGain 2015 $552 $1,985 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] 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 19

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$20M pa direct revenue opportunity >US$25M upfront & royalties 20

21 PapType optimal screening for China One size does not fit all! HPV Type distribution responsible for Cervical Cancer in China HPV sub-type distribution of positive HPV infections HPV 18 8% HPV 33 4% HPV 31 3% 8,000 7,000 6,000 5,000 HPV 52 10% 4,000 3,000 2,000 1,000 HPV 58 13% HPV 16 62% - HPV 52 HPV 16 HPV 58 HPV 68 HPV 18 HPV 51 HPV 31 HPV 39 HPV 33 HPV 66 HPV 56 HPV 35 HPV 45 HPV 59 16/18 genotyping less suited to China market 21

22 Beckman Coulter CytoFLEX TM and DxFLEX TM 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 22

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 23

24 3 to 4 test menu helps utilise capacity HT system capable of > 140K tests pa 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 pricing ~$500-$1,000 per embryo Pricing for comprehensive chromosomal aneuploidies < $100 may drive market growth our goal is a test menu of ~10 assays! 24

25 Why Invest in Genera? 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+) 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 25

26 Upcoming Newsflow next 12 months Indicative Date END Q : END Q2 CY2019 : Q2 CY2019 : Q3 CY2019 : Q3 CY2019 : Q1 CY2020 : Q2 CY2020 : Milestone Market launch of new i5 automation system with PapType reflex Licensing agreement for PapType (US & Canada) STIplex test launched on new i5 system Licensing agreement for PapType (China) and broader 2 nd source IVD reagent manufacture India market launch RUO China market launch RUO Brazil market launch RUO END CY to 2 Companion Diagnostic test development partnerships 26

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28 Sensitivity Genera Technology Corporate Snapshot Genera Tests Sensitivity 1.0 Displays indicative threshold for Meijer compliant HPV screening assay APTIMA BD Viper Cobas HC2 Cytology > Mild RealTime PapType without genotype specific risk Roche CINtek p16 PreTect HPV-Proofer Genera clinical results show high sensitivity, comparable to other high throughput, high sensivity HPV tests on the market. 1 - 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:

29 Sensitivity 0.8 Genera Technology Multiplexing Can Increase Specificity APTIMA BD Viper Cobas HC2 RealTime PapType without genotype specific risk 0.9 Cytology > Mild PapType applying hierarchical typing algorithm : Demonstrates the power of complete genotyping for increased specificity 0.8 Roche CINtek p16 PreTect HPV-Proofer Genera clinical results show very high specificity with little loss of sensitivity, using the power of complete High Risk HPV genotyping. 0.7 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:

30 Corporate Snapshot Dec 1 st 2017 the new algorithm Cytology ~ 70% sensitivity Types 31, 33 should have immediate colposcopy Approximately 9 to 13% depending on age of patient Acquisition of different high risk HPV type = unnecessary colposcopy 30

31 Global KOLs are getting behind the Corporate Snapshot power of complete HPV Genotyping 31