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Abnova Interim / Quarterly Report 2017

Aug 18, 2017

52384_rns_2017-08-18_2f2d74c3-9e6f-4b34-adf8-6680341a318c.pdf

Interim / Quarterly Report

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1

Safe Harbor Notice

The following pages contain projections & estimates of financial information as well as market and product developments for future periods. These projections & estimates are based on information currently available which we believe to be reliable, but they involve risks & uncertainties. Our actual results of operations & financial condition may differ significantly from those contained in the projections & estimates. The projections & estimates should not be interpreted as legally binding commitments, but rather as flexible information subject to change occasionally.

2

Agenda

Company Overview

Q2&H1-2017 Financial Results

Abnova’s Opportunities in Precision Medicine

Q&A

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I. ABNOVA COMPANY PROFILE

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Abnova Company Profile

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Bioreagent Global Distribution Network

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Consolidated Income Statement Q2&H1 2017

In NT$K
Q2‘17 % Q2‘16 % H1‘17 % H1‘16 % H1 YOY
Net Revenue 122,348 100.0% 111,519 100.0% 242,005 100.0% 229,327 100.0% 5.5%
Cost of Revenue (65,174) (53.3%) (60,178) (54.0%) (125,725) (52.0%) (121,763) (53.1%) 3.3%
Unrealized Gross Profit
on Sales to Associates
(2,190) (1.8%) (3,261) (1.3%)
Gross Profit 54,984 44.9% 51,341 46.0% 113,019 46.7% 107,564 46.9% 5.1%
Operating Expense (42,750) (34.9%) (42,399) (38.0%) (82,455) (34.1%) (80,606) (35.1%) 2.3%
Operating Income 12,234 10.0% 8,942 8.0% 30,564 12.6% 26,958 11.8% 13.4%
Non Operating Income 8,098 6.6% 383 0.3% 3,518 1.5% (407) (0.2%) (964.4%)
Income before Tax 20,332 16.6% 9,325 8.4% 34,082 14.1% 26,551 11.6% 28.4%
Income after Tax 17,027 13.9% 13,216 11.9% 28,884 11.9% 27,876 12.2% 3.6%
Basic EPS after Tax 0.29 0.22 0.49 0.47

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Revenue Breakdown by Product

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In NT$K 2017 Jan-Jul
500000
16,739
400000 16,661
69,542
66,469 4.5%
16.9%
300000
48,354
200000 38,441 13.5%
65.1%
100000
339,844 332,794 186,202
0
2015 2016 2017Jan-Jul
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Antibody & Reagent Protein CTC instrument & kits Others

Antibody & Reagent Protein CTC instrument & kits Others

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II. ABNOVA PRECISION MEDICINE

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Abnova Core Competence in Precision Medicine A Vertically Integrated In Vitro Diagnostic Company

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In Vitro Diagnostics
CytoQuest CR
System Integration CytoQuest Dx
GMP Bioreagents CytoBot
Instrumentations CytoAmp
Softwares CytoPrep
Antibody Bank
One Gene One Antibody
Resource & Support
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Applications of Prenatal & Cancer Precision Medicine

Precision Medicine

Prenatal Prevention and Detection

Cancer Prevention and Detection

  1. Amniocentesis (Invasive Prenatal Testing)

  2. NIPT (Non-Invasive Prenatal Testing)

  3. NIPD (Non invasive prenatal diagnosis)

  4. Surrogate Diagnosis

  5. Early Cancer

  6. Cancer Relapse

  7. Cancer Metastasis

  8. Drug Guidance

  9. Drug Resistance

  10. Treatment Response

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Tissue vs. Liquid Biopsy in Precision Medicine

Tissue Biopsy

Liquid Biopsy

  • Invasive

  • Non-invasive

  • Painful

  • Time saving

  • Costly

  • Real-time monitoring

  • Takes time

  • Regular monitoring

  • Risky

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  • Not enough tissue sample available

  • Liquid Biopsy isNot enough tumor tissue in the sample useful when there is:A hard-to-reach tumorNeed for regular monitoring

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Liquid Biopsy Applications in Precision Medicine

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CTC cfDNA Samples: 1. Blood 2. Urine 3. Other body fluid Exosome Detection Monitoring Surrogate Diagnosis Treatment Response Early Cancer Screening Drug Resistance Cancer Metastasis Cancer Relapse/Recurrence Drug Guidance

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Abnova Precision Medicine Market Footprint in China, Japan & Taiwan

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Abnova Diagnostics (Tokyo)

Wellconn Genomics (Neihu)

Abnova Diagnostics (Dongguan) Wellconn Genomics (Dongguan)

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III. ABNOVA DIAGNOSTICS (PRECISION MEDICINE PRODUCTS)

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CytoQuest™ CR

Circulating Rare Cells Positive Enrichment & Retrieval System

Integrated System

  • Buffer reservoir

  • Fluidic pump

  • SCx™spiral chamber

  • Coupler

  • HBx™micromixer

  • Chip receptor

  • TCx™thermal chuck

  • Touch user interface

Antibody-based, cell capture

  • Cell enumeration (CytoChipNano)

  • Single cell isolation (CytoChipNano)

  • Thermal cell release (CytoChipNano CR)

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CytoQuest CTC Bioreagents & Consumables

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Unique Features of CytoQuest™ CR (1)

Capture & Recovery Rate of Spiked Cells in Whole Blood

Abnova Proprietary Cell-Surface Vimentin Antibody is Universal for CTC, EMT CTC, & CSC. Cell-Surface Vimentin is Specific for Cancer

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Abnova Proprietary EpCAM Antibody
Capture Rate Depends on Quality of Antibody
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Unique Features of CytoQuest™ CR (2)

Viable CTC Capture in Diverse Cancers

Single Cell Isolation, Whole Genome Amplification (WGA), & Sequencing

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On-Chip Molecular Analysis with FISH Probes

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Viable CTC Release in Epithelial Cancers

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CytoQuest™Dx Circulating Tumor Cell Positive Enrichment & Retrieval Automation

CytoQuest™ Dx Integration

  • Total Solution Workstation

  • XYZ Axis and 6 Axial Robotic Arm

  • In-Process Controls & Sensors

  • Intelligent Software Algorithm

  • Self-Contained Modules

  • RFID Consumable Tracking

  • Clean Environment & HEPA Filter

CytoQuest™ Dx Advantages

  • Precision, Accuracy, & Reproducibility

  • High Throughput & Multi-Tasking

  • Minimize Cross Contaminations

  • Positive Selection Cell Isolation

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CytoBot™

Circulating Tumor Cell Negative Enrichment & Retrieval Automation

CytoBot™ Integration

  • Total Solution Workstation

  • Two 6 Axial Robotic Arms

  • In Process Controls & Sensors

  • Intelligent Software Algorithm

  • Self-Contained Instruments

  • Clean Environment & HEPA Filter

CytoBot™ Advantages

  • Precision, Accuracy, & Reproducibility

  • High Throughput & Multi-Tasking

  • Minimize Cross Contaminations

  • Negative Selection Cell Isolation

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Proprietary Cell-Surface Vimentin (CSV) Antibody Universal CTC, EMT CTC, and CSC Antibody Cell-Surface Vimentin (not EpCAM) is Specific for Cancer

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CSV+ CD133- CSV- CD133+
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Figure 1. Analysis of colon cancer derived CSV+ CD45- CTCs from patient samples stained with EMT marker specific antibodies and anti-CSV monoclonal antibody, clone 84-1.[1]

Satelli A., et al., Clinical Cancer Research 2015; 21(4): 899-906. Mitra A., et al., International Journal of Cancer 2015; 137: 491-496.

Figure 2. A) Matrigel sphere formation assay of CSV+ CD133- and CSV- CD133+ cells isolated from hepatocellular carcinoma (HCC) at Day 7. Both spheres were stained with stem cell associated markers, Sox2 and Oct4A. B) CSV+ CD133- cells from HCC metastasize at a higher rate than CSV- CD133+ and CSV- CD133- cells.[2]

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Proprietary Cell-Surface Vimentin (CSV) Antibody CTC Clinical Applicable for EMT and Mesenchymal Tumors

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Cancers Epithelial Tumors

EMT Tumors Mesenchymal Tumors (Glioma, Sarcoma, Melanoma)

Curr Pathobiol Rep (2014) 2: 21-26.

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Cell-Surface Vimentin (CSV) Publications

Author Year Journal
Izhar Singh
Batth
2017 Circulating tumor markers: harmonizing the yin and yang of CTCs and ctDNA for
precision medicine.
Annals of Oncology
Arun Satelli 2016 Potential role of nuclear PD-L1 expression in cell-surface vimentin positive
circulating tumor cells as a prognostic marker in cancer patients.
Scientific Reports
Hyangsoon Noh 2016 Discovery of cell surface vimentin targeting mAb for direct disruption of GBM
tumor initiating cells.
Oncotarget
Abhisek Mitra 2015 EMT, CTCs and CSCs in tumor relapse and drug-resistance.
Oncotarget
Arun Satelli 2015 Circulating Tumor Cell Enumeration with a Combination of Epithelial Cell
Adhesion Molecule– and Cell-Surface Vimentin–Based Methods for Monitoring
Breast Cancer Therapeutic Response.
Clinical Chemistry
Abhisek Mitra 2014 Cell-surface Vimentin: A mislocalized protein for isolating csVimentin+CD133-
novel stem-like hepatocellular carcinoma cells expressing EMT markers.
International Journal of Cancer
Arun Satelli 2014 Epithelial–Mesenchymal Transitioned Circulating Tumor Cells Capture for
Detecting Tumor Progression.
Clinical Cancer Research
Arun Satelli 2014 Epithelial–Mesenchymal Transitioned Circulating Tumor Cells Capture for
Detecting Tumor Progression.
Clinical Cancer Research (Supplement)
Arun Satelli 2011 Vimentin as a potential molecular target in cancer therapy Or Vimentin, an
overview and its potential as a molecular target for cancer therapy.
Cellular and Molecular Life Sciences

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CTC Clinical Applications Disease, Drug, & Surgery – Detection, Selection, & Monitoring

  • Disease Detection & Monitoring

  • Surrogate Diagnosis

  • Early Cancer Detection

  • Remission

  • Relapse/Recurrence

  • Metastasis

  • Drug Selection & Monitoring

  • Drug Guidance (Companion Diagnostics)

  • Drug Response

  • Drug Resistance

  • Surgical Selection & Monitoring

  • Surgical Guidance

  • Surgical Response

  • Surgical Resistance

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Cancers & CSV CTC Clinical Applications (1)

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Cancers & CSV CTC Clinical Applications (2)

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Viable CTC Capture & Detection in Diverse Cancers (1)

Cell-Surface Vimentin as Novel EpithelialMesenchymal Transition and Cancer Stem Cell Biomarkers for Pancreatic Cancer Circulating Tumor Cells

EpCAM CK Positive Circulating Tumor Cells and B7-H3 CD105 Positive Cancer Stem Cells in Clear Cell Renal Cell Carcinoma

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Capture and Isolation of EpCAM and CD133 Positive Cells in Peripheral Blood of Non-Small Cell Lung Cancer Patients

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PSMA vs EpCAM Antibody Capture of Circulating Tumor Cells in Metastatic Castration-Resistant Prostate Cancer Patient

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Viable CTC Capture & Detection in Diverse Cancers (2)

CDX2 Intestinal-Specific Expression in Circulating Tumor Cells of Metastatic Colorectal Adenocarcinoma Patient

Plastin-3 Transformed Circulating Tumor Cells in Hepatic Protal Vein of Pancreatic Cancer Patient for Predicting Liver Metastasis

Androgen Receptor Gene Amplification in Circulating Tumor Cells of Metastatic Castration-Resistant Prostate Cancer Patient

Cell-Surface Vimentin Transformed EMT CTCs and CSCs in Metastatic Castration-Resistant Prostate Cancer

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Cell-Surface Vimentin and Pan Cytokeratin Positive Circulating Tumor Cells in Pleural Effusion of Lung Adenocarcinoma Patient

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Antibodies Targeting ASGPR and PanCK for Capture and Identification of Circulating Hepatocellular Carcinoma Cells

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Viable CTC Capture & Detection in Diverse Cancers (3)

Circulating Epithelial Cells in Dialysis Patient with Antibodies Targeting HLA-G and PanCK for Acquired Cystic Kidney Disease Capture and Identification of Circulating Choriocarcinoma Cells

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Detection of Circulating Tumor Cells in Cholangiocarcinoma Patients

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Circulating Tumor Cells as Metastatic Biomarker in Oral Squamous Cell Carcinoma

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Prenatal Detection of Fetal Trophoblasts in Maternal Circulation

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On-Chip in situ mutaFISH™

Mutation Detection without Single Cell Isolation, PCR, WGA, NGS

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mutaFISH™ Sensitivity Compared to dPCR, Nanostring, NGS

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Nucleic Acid Research (2017) 45(8): e59.

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III. WELLCONN DIAGNOSTICS (PRECISION MEDICINE SERVICES)

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CytoQuest™ Workflow

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CytoQuest™ CR

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Certified Medical Personnels

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Man
Wellconn-QP01 組織與管理作業程序
Environment Mechanical
Wellconn-QP15 安全衛生與環境監控作 Wellconn-QP16 設備與試劑耗材管理作
業程序 業程序
懷慷醫事檢驗所
品質系統文件(4M1E)
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Method

Wellconn-QP02 品質管理系統作業程序 Wellconn-QP03 文件管制作業程序 Wellconn SOP-C00 CytoQuest™CR作業標準 Wellconn SOP-C01 CytoQuest CR校正作業標準 Wellconn SOP-C02 CytoQuest CR 試劑檢驗作業 標準

Material

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Wellconn-QP06 供應商評選作業程序
Wellconn-QP16 設備與試劑耗材管理作業程序
Wellconn-QP17 檢體採集與運送管理作業程序
Wellconn-QP18 檢體採集手冊
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Wellconn Customers

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Circulating Tumor Cell Service (1)

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Circulating Tumor Cell Service (2)

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