Slide 1: Financial results for the year ended 31st December 2015
Financial results for the year ended 31st December 2015 Julian Baines, Chief Executive Officer Richard Evans, Finance Director & COO 12th April 2016
Slide 2: Agenda
Agenda Slide no. 3. Introduction 4. Commercial and operational update 5. Financial performance 6. Point-of-Care 9. Central Laboratory 10. Pipeline 11. Regulatory status 12. 2016 Outlook 13. Summary Appendices 2
Slide 3: Introduction
Introduction First Quarter Revenue (£) • Board composition: 9,000,000 • Board aligned on strategy of achieving organic growth 8,000,000 • Company restructure: • Reduced headcount and sites 7,000,000 • Cost savings of £6.7m p.a. 6,000,000 • Organic growth achievable from a variety of sources: 5,000,0
Slide 4: 2015: A challenging year
2015: A challenging year • Revenues down 19% to £30.0m (2014 restated: £37.1m) • Restructuring of company: 40 • Disposal of Selah Genomics • Decision to close Walton-on-Thames facility 35 • Closure of Dublin facility and proposed disposal of RUO biomarker products • Moth-balled EKF Molecular Diagnos
Slide 5: Financial performance
Financial performance Underperformance from acquisitions 40 • Gross profit down 23% to £14.7m (2014 restated: £19.2m) 35 • AEBITDA down to (£0.3m) (2014 restated: £6.7m) 30 • Cash used in operating activities: £2.9m (2014 £3.3m used) 25 • Net debt of £8.8m (2014: £2.1m net cash) 2012 • £m Write-off
Slide 6: Point-of-Care: Hematology
Point-of-Care Hematology • ‘Regular’ business (exc. Mexico tenders) up c. £950k • Hemo Control up 16% YoY Hematology range DiaSpect Tm • Hematastat II up 131% YoY Hematastat II • DiaSpect T/Tm/CompoLab sales flat Hemo Control • 2016 strategy to focus on: HemoPoint H2 • New H2 distribution strategy i
Slide 7: Point-of-Care: Diabetes
Point-of-Care Diabetes • Revenues down £160k (-2%) YoY • Sales of Biosen and Quo-Test in China impacted by regulatory issues Diabetes range • 41% increase in Quo-Test revenue. Publication of positive evaluations Biosen C-Line by NGSP and KoLs. Registration of CE mark for Quo-Test and Quo-Lab Biosen
Slide 8: Point-of-Care: Maternal & Women's Health
Point-of-Care Maternal & Women’s Health • Revenues up £209k (+9%) YoY • Opened market for Creamatocrit in China Maternal & • 13% increase in sales of pregnancy kits primarily in Latin America Women’s Health and USA range • 2016 strategy to focus on: Lactate Scout+ • Build Chinese market with Lactate
Slide 9: Central Laboratory
Central Laboratory Clinical chemistry, centrifuges and enzymes • Total central laboratory sales +£400k (+5%): Central • 6% increase in sales of Beta-Hydroxybutyrate Liquicolor reagent Laboratory range • 8% increase in ‘standard’ chemistry range Clinical chemistry Contract • £100k increase in sales o
Slide 10: Pipeline
Pipeline DiaSpect Tm • Clinical trials underway. Submit for FDA 510k and CLIA waiver in 2016 sTNFR1/2 • Ongoing discussions with major pharma brands on licensing opportunities Inborn Errors of Metabolism (PKU) • Ongoing discussions with major food supplement brand on licensing opportunities 10
Slide 11: Regulatory
Regulatory Product Country Status DiaSpect Tm Clinical trials underway for FDA 510k. Trial duration will be three USA months. Submission for CBER (blood banks) and CDRH (all other uses) Russia Clinical trials underway as part of registration Mexico Registration complete Peru, Turkey, Malaysia, Regis
Slide 12: 2016 Outlook
2016 Outlook Cumulative sales against (draft) budget Positive start to 2016 35,000 • 115% of Q1 budget 30,000 • Sales of B-HB +80% 25,000 20,000 £'000 • Strong performances across all regions, 15,000 especially USA 10,000 • Upside expected from: 5,000 - • Altair 240 analyser and reagent sales 2016 2
Slide 13: Summary
Summary • Focused on the core business • Strategic approach is underpinned by investor feedback • Centralised manufacturing operations to four sites • Reduced headcount and implemented site closure programme • Prioritisation of key markets: – USA: Relaunch of HemoPoint H2; FDA DiaSpect Tm – India: D
Slide 14: Appendices
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Slide 15: Consolidated income statement
Consolidated income statement Total 2015 Total 2014 +/- £’000 £’000 £’000 Revenue 30,045 37,106 (7,061) Gross profit 14,669 19,246 (4,577) GP % 48.8% 51.8% (3.0%) Net admin. costs (15,382) (13,470) (1,912) Other income 139 371 (232) AEBITDA 347 6,659 (6,312) Share based payments (226) (512) 286 Exce
Slide 16: Balance Sheet / Cashflow
Balance Sheet / Cashflow 2015 2014 +/- £’000 £’000 £’000 Intangible assets 42,927 93,522 (50,595) Inventories 8,234 5,793 2,887 Trade / other receivables 7,242 16,115 (9,361) Net (debt) / cash (8,825) 2,100 (10,925) Deferred considerations 485 8,493 (8,008) Trade / other payables 8,331 7,943 388 16
Slide 17: Balance Sheet: Assets
Balance Sheet: Assets FY 2015 FY 2014 +/- Selected items £’000 £’000 £’000 Non-current assets Property, plant, equipment 10,680 10,568 112 Intangible assets 42,927 93,522 (50,595) Investments 402 1,152 (750) Deferred tax assets 340 238 102 Total non-current assets 55,346 105,480 (49,532) Current ass
Slide 18: Balance sheet: Equity & liabilities
Balance sheet: Equity & liabilities FY 2015 FY 2014 +/- Selected items £’000 £’000 £’000 Equity attributable Total equity 46,754 87,376 (40,622) Non-current liabilities Borrowings 1,167 2,492 (1,325) Deferred considerations - 9,536 (9,536) Deferred tax liabilities 3,559 13,258 (8,106) Total non-curr
Slide 19: Cashflow
Cashflow FY 2015 FY 2014 +/- £’000 £’000 £’000 Cash at beginning of period 8,346 2,551 5,795 Cash used in operating activities (4,285) (4,744) (459) Cash used in investing activities (5,315) (15,874) (10,559) Cash used in financing activities 3,269 26,390 (23,121) Net increase / (decrease) in cash (
Slide 20: Unit sales of analysers
Units sold Unit sales of analysers Hemo Control 35,579 2008 - 2015 STAT-Site M Hgb 17,874 3% 2% DiaSpect T/Tm 15,249 4% 3% Hemo Control 5% Lactate Scout+ 8,949 STAT-Site M Hgb 38% DiaSpect T/Tm Quo-Lab A1c 4,522 10% Lactate Scout+ Quo-Lab A1c HemataSTAT II 3,511 16% HemataSTAT II 19% Biosen C-Line /
Slide 21: Tests sold 2015
Tests sold 2015 2014 2015 Biosen 23,454,400 19,955,600 -17.53% Hemo Control / HemoPoint H2 19,717,500 11,491,450 -41.72% Hematastat II 6,634,000 10,377,000 36.07% DiaSpect T and Tm 4,736,500 5,749,000 17.61% UltraCrit 1,901,700 2,370,750 19.78% STAT-Site M Hgb 1,674,200 1,097,500 -34.45% Quo-Test A1
Slide 22: Diabetes: Quo-Lab, Quo-Test, Biosen
Diabetes Quo-Lab Quo-Test Biosen Parameter HbA1c HbA1c Glucose 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 Manufactured Germany
Slide 23: Anemia: DiaSpect Tm, Hemo Control
Anemia DiaSpect Tm Hemo Control UltraCrit HemataSTAT Parameter Hemoglobin Hemoglobin Hematocrit Hematocrit Time to results 1 second 20 seconds 30 seconds 60 second spin Accuracy - < 2% CV < 0.8% CV +/- 0.5% Sample size 10 μl 8 μl 40 μl - Memory None 4,000 results - None Connectivity 2.0 Bluetooth LI
Slide 24: Lactate
Lactate Lactate Scout+ SensPoint Biosen Parameter Lactate Lactate 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 PC / Bluetoo
Slide 25: 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 26: Laboratory centrifuges
Laboratory centrifuges 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
Slide 27: 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 rosta of customers • Sales up 8% 2012-20
Slide 28: Novel renal biomarkers
Novel renal biomarkers sTNFR1 & 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 for
Slide 29: Thank you
Thank you Diagnostics | — <r | for life