Quotient Limited. Jefferies Healthcare Conference. June 2017

Transcription

1 Quotient Limited Jefferies Healthcare Conference June 2017

2 Safe Harbor Statement This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of These forwardlooking statements include statements regarding our expectations of continued growth, the development, regulatory approval, commercialization, and impact of MosaiQ and other new products (including our current expectations regarding the timing of MosaiQ project milestones) and forecasts of the demand for MosaiQ Microarrays and our expected sources of funding. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include delays or denials of regulatory approvals or clearances for products or applications; market acceptance of our products; the impact of competition; the impact of facility expansions and expanded product development, clinical, sales and marketing activities on operating expenses; delays or other unforeseen problems with respect to manufacturing, product development or field trial studies; adverse results in connection with any ongoing or future legal proceeding; continued or worsening adverse conditions in the general domestic and global economic markets; as well as the other risks set forth in the company's filings with the Securities and Exchange Commission ( SEC ). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Quotient disclaims any obligation to update these forward-looking statements. The Quotient logo and MosaiQ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions. Any images, schematics or other graphic or pictorial representations contained herein, including those representing the MosaiQ Instrument or Microarrays, are for illustrative purposes only. Those representations may change and may not accurately represent final Quotient products or services. This presentation contains statistics and other data that in some cases have been obtained or compiled from information made available by third parties. Quotient makes no representation or warranty, expressed or implied, with respect to the accuracy, reasonableness or completeness of such information.

3 Company Mission To transform transfusion diagnostics through the provision of a comprehensive automated testing solution Lowering costs.... improving patient outcomes.

4 MosaiQ Overview Substantial market opportunity; commercial launch scheduled for 2017 Initial target market Transfusion Diagnostics Blood grouping (donor and patient) and donor disease screening MosaiQ Disruptive automation solution for Transfusion Diagnostics Annual customer expenditure - $3.4 Billion Largely reagent and consumable spend. >180 million samples tested annually (1)(2). Fully reimbursed today European launch 2017 Assays achieving target results, manufacturing facility commissioned, first commercial ready instrument received Initial QTNT commercial focus donor testing Donor testing the highest value customers. Concentrated customer base accelerates commercial launch Favorable competitive environment Fragmented; multiple and aging instrument platforms; complex reagent needs; labor intensive; standard of care limited by cost Patient testing partnered with Global #1 Ortho Clinical Diagnostics validates MosaiQ both technically and commercially. Accelerates entry into patient testing market (1) Developed world only; (2) Donor red cells, donor plasma and patient blood grouping

5 MosaiQ Status Manufacturing facility Commissioned and validated MosaiQ Instrument First commercial ready instrument received Commercial Launch 2017 Final product validation, prior to field trials Underway. Expected to be completed in July 2017 European field trials MosaiQ IH Microarray and MosaiQ SDS Microarray to commence in CY3Q17 US field trials Expected to be completed in CY2H commercial launch in Europe Responding already to EU tenders. US commercial launch in early 2019

6 Transfusion Diagnostics Over 180 million patient and donor samples tested annually (1) Ensuring the supply of compatible and safe blood (and blood products e.g. plasma) from donors to patients worldwide Patients 90M Blood Groups Annually (1)(2) Donor Red Cells 56M Donations Annually (1)(2) Donor Plasma 35M Donations Annually Blood Grouping (Antigen Typing, Antibody Detection) Serological Disease Screening Molecular Disease Screening MosaiQ IH Microarray MosaiQ SDS Microarray MosaiQ MDS Microarray (1) Developed world only. (2) Company estimate

7 Transfusion Diagnostics Market - $ Value Two-thirds donor testing (Quotient focus); one-third patient testing Transfusion Diagnostics Annual Expenditure Donor SDS $875M Donor MDS $1,100M $3.4 Billion Global Market Donor Blood Grouping $325M Patient Blood Grouping $1,100M SDS Serological Disease Screening; MDS Molecular Disease Screening

8 MosaiQ Automation Solution Disruptive, next-generation testing platform for Transfusion Diagnostics Multiplex testing capability Capable of undertaking up to 132 tests simultaneously - to detect antigens, antibodies and DNA/RNA MosaiQ Transformative automation solution Highly innovative solution Full automation; comprehensive characterization of blood; single instrument; strong IP position Leveraging existing, well understood assays Accelerating adoption; reducing regulatory time lines and risk Delivering major cost savings for users Eliminating need for routine manual testing, combining multiple instrument platforms, materially lowering costs Advancing patient care Allowing for better matching of donor and patient blood. Standard of care - no longer be limited by cost

9 MosaiQ Changes the Paradigm The Blood Bankers current toolbox multiple reagents (gel cards, antibodies and red blood cells), significant consumable requirements - COMPLEXITY MosaiQ - delivering a fully automated solution for transfusion diagnostics

10 MosaiQ - Single, Unified Instrument Platform Optimizing processes, reducing costs, advancing patient care Serologic Disease Screen Abbott (Prism) OCD (Summit) ABO & Rhesus Beckman Coulter (PK7300) Molecular Disease Screen (NAT) Grifols (Tigris/Panther) Roche (Cobas) Antibody Screen Immucor (Galileo/Neo) Ortho (Vision) Bio-Rad (IH-1000) Grifols (Erytra) Manual Testing Ortho, Immucor, Bio-Rad, Grifols, Quotient, Diagast, Sanquin

11 MosaiQ - Planned Testing Menu MosaiQ will offer the most comprehensive automated testing menu for Blood Grouping and Disease Screening on a single instrument platform Reverse Grouping/Antibody Detection Antigen Typing Serological Disease Screening Family Specificity Family Specificity Pathogen ABO A, B, A1 ABO A (A 1, A 2, A x ), B Syphilis Rh D, C, c, E, e, C w D D, Weak D, DVI Variant CMV Kell K, k, Kp a, Kp b, Js b Rh C, c, E, e, C w HBsAg + Anti-HBc Duffy Fy a, Fy b Kell K, k, Js a, Js b HCV Kidd Jk a, Jk b Duffy Fy a, Fy b Anti-HIV 1/2 + HIV Ag Lewis Le a, Le b Kidd Jk a, Jk b HTLV I/II MNS M, N, S, s Lewis Le a, Le b Chagas P P1 Lu Lu a, Lu b Xg Xg a Diego Di a Other U, Wr a Direct Antiglobulin Test (DAT) Antibody Anti-IgG, Anti-IgG1, Anti-IgG3, Anti-C3d MNS M, N, S, s P P1 Lu Lu b, Diego Di a Molecular Disease Screening (NAT) Pathogen HIV 1/2 HBV HCV West Nile Virus Zika Other (HAV, HEV, Parvo)

12 MosaiQ Instrument Unified platform for blood grouping and donor disease screening High throughput, flexible Daily processing - 3,000 microarrays; 1:1 sample to Microarray aligns workflow; flexible STAT loading MosaiQ Transformative automation solution True walkaway solution Microarrays and consumables loaded at the beginning of each shift. Thereafter just load samples Two variants planned 10-Rack (120 samples); Track Capable (continuous load) Known time to result Less than 35 minutes for blood grouping Commercial instrument Formal validation underway. First commercial ready instrument received

13 Commercial Launch Expected Timeline Development Validation/Field Trials Commercialization MosaiQ Manufacturing MosaiQ Instrument MosaiQ IH Microarray (Phase I & II) EU Field Trials CY3Q17 U.S. Field Trials CY2H17 EU CY2H17 U.S. CY1H19 MosaiQ SDS Microarray (CMV & Syphilis) EU Field Trials CY3Q17 U.S. Field Trials CY2H17 EU CY2H17 U.S. CY1H19 MosaiQ SDS II Microarray (Mandated Serological Disease Screening Panel) Months Months MosaiQ MDS Microarray (Mandated Molecular Disease Screening Panel) Years Years

14 Commercial Opportunity Market structure well suited to Quotient Transfusion diagnostics - $3.4 billion addressable market Fully reimbursed today 100% of commercial rights retained by Quotient for the key donortesting markets in North America and Europe Highly concentrated donor testing market Commercial success of MosaiQ delivered by 5-10 customers High-volume processes well suited to automation/mosaiq Ongoing need to significantly reduce costs costs increasing, volumes have fallen Record of rapid adoption of new technologies Patient testing market to be addressed by Ortho Clinical Diagnostics Current Global #1 in Transfusion Diagnostics Accelerates entry into the key patient testing market No need to build complex/extensive infrastructure to address this market Razor:Razorblade business model Place instruments Enter into long-term contracts (5-7 years) to supply Microarrays (consumables)

15 Top-10 Target Customers/Customer Groups Target Customer Donor Red Cells: Annual Samples Blood Grouping Serological Disease Screening Molecular Disease Screening Potential Annual Microarray Demand Target Customer #1 (Field Trial Site) 5,400,000 Yes Yes Yes 16,200,000 Target Customer #2 (Field Trial Site) 2,700,000 Yes Yes Yes 8,100,000 Target Customer #3 4,100,000 Yes Yes Yes 12,300,000 Target Customer #4 (Field Trial Site) 3,400,000 Yes Yes Yes 10,200,000 Target Customer #5 3,100,000 Yes Yes Yes 9,300,000 Target Customer #6 (Field Trial Site) 2,100,000 Yes Yes Yes 6,300,000 Donor Plasma: Target Customer #7 Yes Yes Target Customer #8 35,000,000 Yes Yes 70,000,000 Target Customer #9 Yes Yes Patient Testing: Hospital/Reference Laboratories Yes

16 MosaiQ - Key Value Proposition Increases plasma and red cell yield; less tubes; reduced logistics and waste; testing of challenging patients automated. Low sample volume requirements Single instrument platform Consolidates multiple instrument platforms onto a single multiplex testing platform. Reducing waste, simplifying reagent/ consumable management. Extended shelf life Reducing Costs Automated, streamlined and simplified processes Eliminates need for routine manual testing. Known time to result (<35 minutes). Same sample for serological and molecular disease screening. No need to pool samples. Quicker turnaround times. Comprehensive and versatile disease screening Comprehensive characterization of donor and patient blood Facilitates enhanced matching, reduces risk of developing antibodies. Lower adverse events. Improves patient outcomes. MosaiQ is designed to address the key challenges faced by donor collection agencies worldwide (i.e. reducing costs and complexity)

17 MosaiQ - Compelling Investment Case Transformative and highly disruptive driving strong revenue build When customers adopt a MosaiQ application, they will adopt for 100% of needs High barriers to entry Razor:Razor Blade business model Place instruments Enter into long-term supply agreements for Microarrays (5-7 years) Donor testing concentrated customer base No need for significant investment in sales and marketing Patient testing partnered with Ortho Clinical Diagnostics Leveraging Ortho s sales and marketing and field service infrastructure Revenue based on % of net sales, which increases as sales increase Highly scalable manufacturing platform Commercial strategy designed to maximize profit opportunity Gross margins 80-90% Operating margins - >60%

18 Investment Highlights Summary MosaiQ - transformative & highly disruptive Full automation; comprehensive characterization of blood; donor disease screening; one instrument platform Major market opportunity $3.4 Billion transfusion diagnostics market Quotient & MosaiQ Compelling value proposition Reducing costs; advancing patient care. The standard of care should no longer be limited by cost Commercial launch Europe 2017; US 2019 Compelling financial case Transformative/disruptive; high barriers to entry; Razor/ Razor Blade model, highly scalable, highly profitable Funding strategy Funding plan to profitability in place

19 Quotient Limited (NASDAQ: QTNT)