Ekf Diagnostics Holdings Plc · LSE:EKF
Ekf Diagnostics — FY2014 Earnings Presentation
35 slides from Ekf Diagnostics's earnings presentation, Mar 16, 2015
Slide 1: Year Ended 31st December 2014
YEAR ENDED 31st DECEMBER 2014 Julian Baines, Chief Executive Officer Paul Foulger, Finance Director 16th March 2015
Slide 2: Agenda
AGENDA Slide 3 Highlights 7 2015 challenges and strategy 10 Point-of-Care 13 Molecular Diagnostics 16 Central Laboratory 18 Financial deliverables 2015 19 Summary 20 Appendices 2
Slide 3: Highlights Full Year 2014
HIGHLIGHTS Full Year 2014 40 • Revenues up 26% to £40.1m (2013: £31.8m) • 18,000+ point-of-care analysers sold 35 • 56m+ tests sold 30 • Transfer of production of HbA1c analysers and tests to 25 Barleben and organ injury biomarkers to Walton-on-Thames 2012 £m 20 • Significant network of collaborator
Slide 4: 2014 Financial Highlights
2014 FINANCIAL HIGHLIGHTS Sustained financial performance 40 • Underlying organic revenues increased by 6% YoY 35 • £6.5m revenue contribution from new acquisitions 30 • Gross profit up 22% to £19.9m (2013: £16.3m) 25 • AEBITDA up 31% to £6.3m (2013: £4.8m) £m 20 2012 • Cash (used in)/generated from
Slide 5: Consolidated Income Statement
CONSOLIDATED INCOME STATEMENT Existing group 2014 Acquisitions 2014 Total 2014 Total 2013 £’000 £’000 £’000 £’000 Revenue 33,612 6,450 40,062 31,804 Gross profit 17,773 2,176 19,949 16,345 GP % 52.9% 33.7% 49.8% 51.4% Net admin. costs (12,137) (1,926) (14,063) (12,016) Other income 371 - 371 495 AEB
Slide 6: Balance Sheet / Cashflow
BALANCE SHEET / CASHFLOW 2014 2013 Highlights £’000 £’000 Intangible assets 93,522 34,725 • Intangibles from 3 acquisitions = £60.8m Inventories 5,793 5,308 • Inventories from acquisitions = £1.3m • Includes £6.5m due from Mexican distributors Trade / other receivables 16,115 7,155 • Receivables fro
Slide 7: Challenges 2015
CHALLENGES 2015 Challenges Mitigating actions • Reduced earn-out Limited lifespan of the DME panel in the USA • Expanded portfolio Delays in product registrations in China and • Counterbalanced by registrations in other USA for A1c analysers countries • POC and MDx portfolios provide cost saving Glo
Slide 8: A Clear Strategy
A CLEAR STRATEGY 2015 deliverables Division Objective Actions Point-of- Drive revenues from business units: • Launch of Hemo Control with connectivity Care Hematology • Expand DiaSpect distributor base Diabetes Care • Improved performance from key accounts: Maternal & Women’s Health Fresenius, Alere
Slide 9: EKF Diagnostics country registrations
EKF DIAGNOSTICS Country registrations 60 • All Quo-Lab registrations are post launch in 2012 50 • 2015 focus to be on driving 40 registrations for Biosen, Hemo Control and 30 DiaSpect Tm 20 Registered 10 Pending 0 9
Slide 10: Point-of-Care: Hematology
POINT-OF-CARE Hematology • Revenues +£4,397k (+51%) YoY EKF range DiaSpect T • Acquisitions have consolidated EKF’s position in the POCT market DiaSpect Tm • 13,460 analysers sold HemataSTAT II • Installed base delivering incremental growth in consumables Hemo Control HemoPoint H2 • 16,405,700 tests
Slide 11: Point-of-Care: Diabetes
POINT-OF-CARE Diabetes • Revenues +£384k (4%) YoY EKF range • Technology transfer of Quo-Test and Quo-Lab from UK to Biosen Germany completed Q3 2014: Quo-Lab Quo-Test • Automated consumable production for both products SSM b-HB • Centralised warehousing and shipping • Centralised Customer Service •
Slide 12: Point-of-Care: Maternal & Women's Health
POINT-OF-CARE Maternal & Women’s Health Lactate EKF range • SensPoint CE marking Q2 Lactate Scout+ SensPoint • European studies undertaken on three applications within obstetrics (birth medicine) • Committee of Key Opinion Leaders established to agree protocols for use in the maternity suite • Beta
Slide 13: EKF Molecular
EKF MOLECULAR Product and services 2014 achievements • Massachusetts General Hospital Cancer Center collaboration led by Daniel Haber MD, PhD: • Circulating Tumour Cell (CTC) detection and analysis • Establishment of fast-track CE marking team • Multiple third party evaluations commissioned for Poin
Slide 14: PointMan v FoundationOne
POINTMAN v FOUNDATIONONE Product comparison Discovery Number of genes 50 215 145 List price $2,000-$4,000 $5,800 TBD Actionable targets Yes Yes Yes Database Better (>25k) Good (5k – 10k) Better Gene fusions No Yes Yes Medicare approval Yes No n/a PMA strategy n/a No Yes
Slide 15: EKF Molecular: A Clear Outlook
EKF MOLECULAR A clear outlook 2015 deliverables • Reimbursement from Medicare Administrative Contractors for PrecisionPath • Private payer strategies for: • Ferrer Incode • Women’s Health panel • Oncomine • Corporate Wellness panel • Proof of clinical utility for existing DME panel • Strengthen rela
Slide 16: EKF Molecular: PointMan
EKF MOLECULAR PointMan PointMan works with all types of biopsy material CTCs, ctDNA, FFPE, cytology And on all types of DNA sequencing technology Next Generation, Sanger, rtPCR, MALDI-TOF, Pyrosequencing Which is why leading cancer technology and drug developers use it MGH, GILUPI, ANGLE 16
Slide 17: Central Laboratory
CENTRAL LABORATORY Clinical chemistry, centrifuges and enzymes • Total central laboratory sales -£783k (-9%) YoY: EKF range Clinical chemistry • £400k negative impact due to currency fluctuations with US$ Contract • £250k due to timing of Roche orders fermentation Enzymes • Growth contributions from
Slide 18: R&D Update
R&D UPDATE sTNFR1 & 2 • Growing interest in applications of sTNFR: • Third party studies from France and Finland accepted for publication 2014 • Increasing interest – and revenues – from large pharma to use sTNFR as a companion diagnostic in the development of drugs for renal disease • Deepening rel
Slide 19: Financial Deliverables in 2015
FINANCIAL DELIVERABLES IN 2015 • Revenue growth of 10% from underlying business • Full year benefit of Quo-Test and Quo-Lab manufacturing transfer to Germany • Full year benefit of Dublin office closure • Further anticipated actions: • Barleben expansion for efficiency savings • Increased volumes; m
Slide 20: Summary
SUMMARY • Management targeting 10% annual growth in 2015: – Approximately twice the industry standard rate of growth • Specific actions in place to deliver growth: – Business Units to focus on developing distributor base, identifying market opportunities and launching products – Focus on obtaining r
Slide 21: Appendices
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Slide 22: Balance Sheet: Assets
BALANCE SHEET: ASSETS FY 2014 FY 2013 +/- Selected items £’000 £’000 £’000 Non-current assets Property, plant, equipment 10,568 9,785 783 Intangible assets 93,522 34,725 58,797 Investments 1,152 250 902 Deferred tax assets 238 903 (665) Total non-current assets 105,480 45,663 59,817 Current assets I
Slide 23: Balance Sheet: Equity & Liabilities
BALANCE SHEET: EQUITY & LIABILITIES FY 2014 FY 2013 +/- Selected items £’000 £’000 £’000 Equity attributable Total equity 87,376 40,922 46,454 Non-current liabilities Borrowings 2,492 2,108 384 Deferred considerations 9,536 5,471 4,065 Deferred tax liabilities 13,258 3,442 9,816 Retirement benefit o
Slide 24: Cashflow
CASHFLOW FY 2014 FY 2013 +/- £’000 £’000 £’000 Cash at beginning of period 2,551 4,331 (1,780) From operating activities (4,778) 2,007 (6,785) From investing activities (15,840) (2,216) (13,624) From financing activities 26,390 (1,560) 27,950 Net increase / (decrease) in cash 5,772 (1,769) 7,541 Exc
Slide 25: Unit Sales of Analysers
Approx. units UNIT SALES OF ANALYSERS Hemo Control 31,905 2008 - 2014 STAT-Site M Hgb 17,107 Hemo Control STAT-Site M Hgb DiaSpect T/Tm 13,972 DiaSpect T/Tm Lactate Scout+ 7,311 Lactate Scout+ Biosen C/S-Line Biosen C/S-Line 2,992 Quo-Lab A1c Quo-Lab A1c 2,797 Quo-Test A1c HemataSTAT II Quo-Test A1c
Slide 26: Diabetes
Diabetes Quo-Lab Quo-Test Biosen Parameter HbA1c HbA1c Glucose and lactate Time to results 4 minutes 4 minutes 20-25 seconds Accuracy < 3% CV < 3% CV < 1.5% CV Sample size 4 μl 4 μl 20 μl Memory 7,000 results 7,000 results 1,000 results Connectivity LIS / printer LIS / printer LIS / printer Manufact
Slide 27: Anaemia
Anaemia SSM Hgb DiaSpect Tm/T UltraCrit Hemo Control HemataSTAT Parameter Hemoglobin Hemoglobin Hematocrit Hemoglobin Hematocrit Time to results 30 seconds 1 – 2 seconds 30 seconds 20 seconds 60 second spin Imprecision - - < 0.8% CV < 2% CV +/- 0.5% Sample size 15 μl 10 μl 40 μl 8 μl - Memory n/a No
Slide 28: Lactate
Lactate Lactate Scout+ SensPoint Biosen Glucose Parameter Lactate Lactate and lactate Time to results 10 seconds 10 seconds 20-25 seconds < 3.4 mmol/L Accuracy < 3% CV < 1.5% CV +/- 0.2 mmol/L Sample size 0.2 μl 0.2 μl 20 μl Memory 250 results 5,000 results 1,000 results Connectivity PC / Bluetooth
Slide 29: Beta-Hydroxybutyrate
BETA-HYDROXYBUTYRATE Clinical chemistry • Beta-Hydroxybutyrate (b-HB) is an enzymatic assay used on clinical chemistry analysers • The test quantifiably detects the presence of the ketones in patients with suspected Diabetic Ketoacidosis (DKA) • b-HB is the primary ketone produced by the body during
Slide 30: Centrifuge Range
CENTRIFUGE RANGE Measures the creamatocrit of mothers’ milk Creamatocrit™ and estimates the calories per ounce The Micro12 centrifuge is used for small Micro12™ volume separation High-speed bench top centrifuge designed to PlasmaPrep-12™ rapidly separate blood in original evacuated collection tubes
Slide 31: Enzyme Manufacturing
ENZYME MANUFACTURING EKF Life Sciences • Based in Elkhart, Indiana • Certified ISO 13485: 2003 facility • Relaunched as EKF Life Sciences 1st July 2014 Manufacturing: • Bulk manufacture of enzymes used in clinical reagents • Global distribution to a blue-chip roster of customers Contract manufacturi
Slide 32: Novel Renal Biomarkers
NOVEL RENAL BIOMARKERS sTNFR1 and 2 • Growing interest in applications of sTNFR1 & 2: • Third party studies from France and Finland accepted for publication Q1 2014 • Qualified interest from pharma businesses for use as a Companion Diagnostics tool • Testing samples from pharma companies scheduled f
Slide 33: MDx Products: PointMan
MDx PRODUCTS: POINTMAN • Better identify patients diagnosed with metastatic melanoma BRAF who are suitable for treatment with Zelboraf • Help predict which patients diagnosed with colorectal cancer KRAS will not respond to novel therapies such as Erbitux and Vectibix • Efficiently identify which pat
Slide 34: MDx Services
MDx SERVICES Selah Genomics • Based in Greenville, South Carolina, USA • CLIA certified ‘test-as-a-service’ molecular laboratory targeting three distinct customer segments: Doctors, pharmaceutical companies and healthcare providers • Growing portfolio of molecular assays to support the development a
Slide 35: Thank you
Thank you Diagnostics | — <r | for life
EKF Diagnostics Holdings — FY2014 Earnings Presentation on 6ix