Pacific Edge Limited · NZX:PEB
Pacific Edge — H1 2020 Earnings Presentation
37 slides from Pacific Edge's earnings presentation, Nov 21, 2019
Slide 1: FY20 Interim Result and Capital Raising Presentation
FY20 Interim Result and Capital Raising Presentation 21 November 2019
Slide 2: Disclaimer
Disclaimer Important Notice Effect of rounding This presentation has been prepared by Pacific Edge Limited (PEL) solely to provide interested parties with further A number of figures, amounts, percentages, estimates, calculations of value and fractions in this presentation are subject to information
Slide 3: About Pacific Edge and Cxbladder
About Pacific Edge and Cxbladder
Slide 4: Pacific Edge Overview
Pacific Edge Overview Global first mover advantage Large portfolio of published clinical evidence Four class leading, proprietary, non-invasive, urine-based diagnostic Products are underpinned by extensive clinical validation and clinical tests (Cxbladder) for the detection and management of urothel
Slide 5: Pacific Edge Investment Opportunity
Pacific Edge1 Investment Opportunity Significant progress underpins reduction in risk profile and proximity to full reimbursement coverage Proximity to significant cash reimbursement event and consequential strong cash uplift • Significant advances have been made in the last 12 months in clinical ev
Slide 6: Recent Achievements Highlight Accelerating Momentum and Adoption of Cxbladder
Recent Achievements Highlight Accelerating Momentum and Adoption of Cxbladder …progressing towards a transformational commercial inflexion point • March 2018: Notification of Product Specific CPT1 codes from the American Medical Association for Cxbladder Detect and Cxbladder Monitor. • August 2018:
Slide 7: Urothelial Cancer is a Significant Global Healthcare Challenge
Urothelial Cancer is a Significant Global Healthcare Challenge • ~ 550,000 new cases in 20181 UROTHELIAL CANCER • ~ 200,000 deaths annually1 • Globally 10th most common cancer but Kidney 6th most common in men1 • High recurrence rates (70% recurrence 5% following treatment) are upper tract (not Uret
Slide 8: Urothelial Cancer is a Significant Healthcare Challenge in the U.S.
Urothelial Cancer is a Significant Healthcare Challenge in the U.S. ~4 million cystoscopies were 4th most common cancer in ~7 million patients performed in 20181 More than 81,000 men in the U.S.3 present with haematuria (many of which are new bladder cancers are annually and 3.4 million are unnecess
Slide 9: Existing Tests and Procedures have Significant Shortcomings
Existing Tests and Procedures have Significant Shortcomings… …they are expensive, invasive and have poor relative performance…providing significant opportunities for new diagnostic tests that are cheaper, non-invasive and more accurate…Cxbladder CYSTOSCOPY CYTOLOGY FISH USE Detection of bladder canc
Slide 10: Cxbladder Revolutionises How Urologists Detect and Manage Urothelial Cancer
Cxbladder Revolutionises How Urologists Detect and Manage Urothelial Cancer World Class Diagnostic Tests Validated by International Urologists - Now in Guidelines • Four class leading, accurate, non-invasive, urine based diagnostic tests for UC addressing multiple unmet needs across the clinical pat
Slide 11: Cxbladder is Used at Multiple Decision Points across the Clinical Pathway
Cxbladder is Used at Multiple Decision Points across the Clinical Pathway HISTORICAL TESTING STANDARD OF CARE CXBLADDER EVALUATION BY PRIMARY Cxbladder Triage PHYSICIAN Primary evaluation of haematuria to Historically, the diagnosis and rule out patients who do not have monitoring of urothelial canc
Slide 12: The Evaluation of Haematuria: Large Global Market Opportunity for Cxbladder
The Evaluation of Haematuria: Large Global Market Opportunity for Cxbladder Cxbladder accurately rules-out patients who do not have UC HAEMATURIA DEMOGRAPHICS CAUSES Microscopic Represents up to 20% Stones ≥3 RBCs1 per high powered field of all urologic visits2 Infection Benign Prostatic Hyperplasia
Slide 13: Cxbladder Provides Actionable Results for Multiple, Physician-Defined, Clinical Needs
Cxbladder Provides Actionable Results for Multiple, Physician-Defined, Clinical Needs Clinical Gaps Clinical Utility of Cxbladder 1. Patients unable to undergo standard work-up: Confirms • Renal insufficiency The absence of UC with high sensitivity AND high NPV3 – • Dye allergies “Power of the Negat
Slide 14: Cxbladder has Multiple Layers of Intellectual Property
Cxbladder has Multiple Layers of Intellectual Property Sample Biomarker RT-qPCR1 Collection Measurement 1 Unique proprietary buffer in the 2 Specific proprietary genomic 3 Proprietary trade secret sample system biomarkers for urothelial cancer algorithms in central repository Midstream urine is coll
Slide 15: Patient Compliance with Current Surveillance Guidelines is Poor
Patient Compliance with Current Surveillance Guidelines is Poor Onerous, invasive and expensive tests and procedures drive a low level of patient compliance with urologists recommendations – resulting in poorer patient outcomes A 2011 study of patients with bladder cancer Of 2017 patients included,
Slide 16: Patients Dislike Invasive Tests
Patients Dislike Invasive Tests Patient Feedback Regarding Cystoscopy: A BCAN1 Survey in > 900 U.S. Patients with UC PATIENTS REPORTED MODERATE TO SEVERE: DISCOMFORT ANXIETY PAIN 56% 65% 38% (n = 890) (n = 905) (n = 906) PATIENT COMMENTS: • “I recommend being put to sleep. Dealing with these while a
Slide 17: Clinical Evidence
Clinical Evidence
Slide 18: Major Peer-Reviewed Publications Highlight the Clinical Validation of Cxbladder
Major Peer-Reviewed Publications Highlight the Clinical Validation of Cxbladder Cxbladder has class leading performance metrics: Sensitivity, Specificity and Negative Predictive Value N Cxbladder Results Publication Outperformed All Patients Samples Sensitivity Specificity NPV Comparator Covered Tes
Slide 19: Major Peer-Reviewed Publications Highlight the Clinical Utility of Cxbladder
Major Peer-Reviewed Publications Highlight the Clinical Utility of Cxbladder Cxbladder significantly reduces the need for expensive, invasive tests N Impact of Cxbladder Results Publication Setting Patients Samples On Diagnostic Tests On Invasive Tests Darling D, Luxmanan C, O’Sullivan P et al. Haem
Slide 20: Diagnostic Out-Performance Published in the World's #1 Urology Journal
Diagnostic Out-Performance Published in the World’s #1 Urology Journal Demonstrates the significant clinical utility of Cxbladder • Diagnostic outperformance published in global number one 1 ranked urology journal, European Urology, in May 2019. • Cxbladder providing enhanced diagnostic outcomes not
Slide 21: Commercial Progress
Commercial Progress
Slide 22: Growing Commercial Adoption in New Zealand Leads the World
Growing Commercial Adoption in New Zealand Leads the World • New Zealand’s public healthcare providers are leading the global adoption of Cxbladder. • Majority have now adopted Cxbladder into their standard of care and, in some cases, their clinical guidelines, replacing cystoscopy. • Demand exceedi
Slide 23: Our Primary Focus: The U.S. Market
Our Primary Focus: The U.S. Market A scale opportunity in both the evaluation of haematuria and monitoring for UC recurrence 1. EY-Parthenon business review of the annual addressable market opportunity for Cxbladder in the U.S. completed February 2018 23
Slide 24: One More Milestone Needed to Obtain National Public Reimbursement in the U.S.
One More Milestone Needed to Obtain National Public Reimbursement in the U.S. CMS - The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that administers the Medicare program and works in partnership with state governments to administer Medicaid and other health programmes.
Slide 25: Estimated Timeframes for Completion of LCD Review
Estimated Timeframes for Completion of LCD Review New CMS review process estimated to take PEB reasonably expects to know the outcome ~6 months from evidence submission of the LCD review process in Q1 2020 • Inclusion in a LCD for reimbursement for CMS patients • The LCD process requires submission
Slide 26: Successful Inclusion in a LCD is Expected to Result in Significant Commercial Growth
Successful Inclusion in a LCD is Expected to Result in Significant Commercial Growth Test adoption and revenue growth: U.S. adoption and demand for Cxbladder is expected to be positively impacted on inclusion in a LCD – which is expected to result in accelerated revenue growth (as evidenced by the g
Slide 27: Institutional Users and Payers in the U.S. Validate Cxbladder
Institutional Users and Payers in the U.S. Validate Cxbladder Healthcare Institutions Commercially Using Major Insurance Companies Paying for Cxbladder Cxbladder • Johns Hopkins Medicine • University of Southern California • Aetna • Carolina Urologic Research Center • University of Rochester • Blue
Slide 28: 1H20 Financial Result Summary
1H20 Financial Result Summary (NZ$’000) 1H201 1H191 % Change Operating Revenue2 (test sales) 2,285 2,033 12% Total Revenue 2,701 2,639 2% Operating Expenses 12,090 11,358 6% Total Comprehensive Loss 9,406 8,718 8% Cash Receipts from Customers 2,350 2,026 16% Net Operating Cash Outflow 7,405 8,612 (1
Slide 29: 1H20 Financial Result Highlights and Commercial Milestones
1H20 Financial Result Highlights and Commercial Milestones • Cash receipts from customers increased 16% on pcp and 37% on 2H19. • Operating revenue from Cxbladder test sales increased 12% on pcp. • Total laboratory throughput increased 10% on pcp to 8,147 tests. • Total laboratory throughput for New
Slide 30: Total Laboratory Throughput Comparison
Total Laboratory Throughput Comparison Full Year Comparison Half Year Comparison 16,000 9,000 14,000 8,000 7,000 12,000 6,000 10,000 5,000 8,000 4,000 6,000 3,000 4,000 2,000 2,000 1,000 0 0 FY15 FY16 FY17 FY18 FY19 1H20 1H15 1H16 1H17 1H18 1H19 1H20 Total Lab Throughput Billable Tests Total Lab Thr
Slide 31: Unique Multi-Market and Multi-Product Opportunity for Cxbladder
Unique Multi-Market and Multi-Product Opportunity for Cxbladder Progressive adoption of the suite of tests provides a unique, global competitive advantage Rest of World 23% Triage 22% Total Laboratory Total Laboratory Throughput Detect Throughput [CATEGOR U.S. Y NAME] 57% Detect by Region by Test Ty
Slide 32: Successful Execution of Key Objectives is Driving Growth
Successful Execution of Key Objectives is Driving Growth Execution of commercial objectives over the short to medium term is expected to result in a step change in growth U.S.: • Achieve the third and final milestone (LCD) for national reimbursement. • Increase the focus on closing institutional cus
Slide 33: Positive Growth Outlook
Positive Growth Outlook Continued growth in commercial Demand from public healthcare Inclusion in the NCCN guidelines sales is expected from new and providers in New Zealand is recommendations for surveillance existing customers. expected to grow strongly and of high risk patients is expected to pos
Slide 34: Capital Raising
Capital Raising
Slide 35: Pacific Edge is seeking to raise NZ$20m through a fully underwritten placement and rights issue
Pacific Edge is seeking to raise NZ$20m through a fully underwritten placement and rights issue Purpose: Summary of Offer Terms: The offer is Placement to provide capital Offer Size $7.0m (46,666,667m shares) fully underwritten resources to assist the company to Offer Price $0.15 per new share, repr
Slide 36: Capital Raising Timetable
Capital Raising Timetable Offer announced 21 November 2019 Placement Placement conducted under trading halt 21 November 2019 Trading expected to resume 22 November 2019 Settlement and allotment of placement shares 26 November 2019 Rights Offer Shares quoted "ex-rights" and Rights trading commence 28
Slide 37: FY20 Interim Result and Capital Raising Presentation
FY20 Interim Result and Capital Raising Presentation 21 November 2019