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Abnova Investor Presentation 2017

Aug 18, 2017

52384_rns_2017-08-18_c1635113-4bcb-414b-8e4a-8c9f77e7348a.pdf

Investor Presentation

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免責聲明

本簡報及同時發佈之相關訊息包含財務、市場暨產品業務等預測性資訊。 本公司未來實際發生的營運結果及財務狀況可能與這些預測性資訊所明示 或暗示的預估有所差異，其原因可能來自於各種本公司所不能掌控的風 險。這些預估及展望的訊息，反應本公司截至目前為止對於未來的看法， 本公司並不負責隨時提醒或更新。

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議程

✓ 公司簡介

  • ✓ 2017年第二季財務成果

  • ✓ 亞諾法生技在精準醫療市場的機會

✓ Q&A

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I. 亞諾法公司簡介

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亞諾法公司簡介

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試劑市場全球經銷商分布版圖

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2017年第二季及上半年合併損益表

In NT$K
Q2‘17 % Q2‘16 % H1‘17 % H1‘16 % H1 YOY
營業收入 122,348 100.0% 111,519 100.0% 242,005 100.0% 229,327 100.0% 5.5%
營業成本 (65,174) (53.3%) (60,178) (54.0%) (125,725) (52.0%) (121,763) (53.1%) 3.3%
未實現銷貨毛利 (2,190) (1.8%) (3,261) (1.3%)
營業毛利 54,984 44.9% 51,341 46.0% 113,019 46.7% 107,564 46.9% 5.1%
營業費用 (42,750) (34.9%) (42,399) (38.0%) (82,455) (34.1%) (80,606) (35.1%) 2.3%
營業利益 12,234 10.0% 8,942 8.0% 30,564 12.6% 26,958 11.8% 13.4%
營業外收入及支出 8,098 6.6% 383 0.3% 3,518 1.5% (407) (0.2%)
稅前淨利 20,332 16.6% 9,325 8.4% 34,082 14.1% 26,551 11.6% 28.4%
稅後淨利 17,027 13.9% 13,216 11.9% 28,884 11.9% 27,876 12.2% 3.6%
基本每股盈餘 0.29 0.22 0.49 0.47

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產品別營收分析

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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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抗體及試劑 蛋白質 CTC儀器及試劑 其他

抗體及試劑 蛋白質 CTC儀器及試劑 其他

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II. 亞諾法精準醫療

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亞諾法在精準醫療的核心競爭力 垂直整合的體外診斷試劑公司

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體外診斷試劑 CytoQuest CR 系統整合 CytoQuest Dx GMP生物試劑 CytoBot 儀器 CytoAmp 軟體 CytoPrep 抗體庫 一個基因，一個抗體 資源與支援

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產前及癌症精準醫療的應用

精準醫療

產前 預防及檢測

癌症 預防及檢測

  1. 羊水檢測(侵入性診斷) 2. 無細胞非侵入性篩檢NIPT (Non-Invasive Prenatal Testing)

  2. 有細胞非侵入性診斷NIPD (Non invasive prenatal diagnosis)

  3. 癌症初期 2. 癌症轉移 3. 治療決策 4. 治療反應 5. 抗藥性 6. 癌症復發

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組織切片

  • 侵入性

  • 疼痛

  • 費用高

  • 費時

液態切片

  • 非侵入性

  • 省時

  • 即時監測

  • 定期追蹤

  • 有風險

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液態切片適用時機:

  • 無法取得足夠組織樣本

  • 樣本中的癌症組織較少

  • 無法進行組織切片的癌症

  • 需定期追蹤監測

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液態切片在精準醫療的應用

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CTC cfDNA 樣本: 1. 血液 2. 尿液 3. 其他體液

Exosome 檢測 監測 早期檢測 治療反應 癌症轉移 抗藥性 治療決策 癌症復發

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亞諾法精準醫療市場布局 (中國、日本& 台灣)

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III. 亞諾法檢測領域 (精準醫療產品)

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亞諾法CytoQuest™ CR 循環腫瘤細胞陽性富集與收集系統

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試劑組

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CytoQuest™ CR 獨特優勢(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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CytoQuest™ CR 獨特優勢(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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亞諾法CytoQuest™ Dx 自動化循環腫瘤細胞陽性富集與收集系統

CytoQuest™ Dx 優點

  • 精密，準確與再現性

  • 高通量和多工

  • 減低交叉污染

  • 抗體補捉法篩擇方式的細胞分離

CytoQuest™ Dx 整合性

  • 具備整體解决方案的工作站

  • 两只6軸機器手臂

  • 過程控制系统和傳感器

  • 智能軟體演算

  • 設備齊全平台

  • RFID追蹤查詢功能

  • 高效濾網维持潔淨環境

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亞諾法CytoBot™ 自動化循環腫瘤細胞陰性富集與收集系統

CytoBot™ 優點

  • 精密，準確與再現性

  • 高通量和多工

  • 減低交叉污染

  • 排除法篩擇方式的細胞分離

CytoBot™ 整合性

  • 具備整體解决方案的工作站

  • 两只6軸機器手臂

  • 過程控制系统和傳感器

  • 智能軟體演算

  • 設備齊全平台

  • 高效濾網维持潔淨環境

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Cell-Surface Vimentin (CSV) 獨家專屬抗體 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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Cell-Surface Vimentin (CSV) 抗體臨床應用 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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CSV單株抗體全球專屬專利授權新聞稿

亞諾法網頁–利害關係人專區-新聞中心 /http://www.abnova.com/images/content/ir/Abnova_CSV.pdf

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Cell-Surface Vimentin (CSV) 論文發表

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臨床應用

Disease, Drug, & Surgery – Detection, Selection, & Monitoring

  • 疾病檢測及監控

  • Surrogate Diagnosis

  • Early Cancer Detection

  • Remission

  • Relapse/Recurrence

  • Metastasis

  • 投藥選擇評估與監控

  • Drug Guidance (Companion Diagnostics)

  • Drug Response

  • Drug Resistance

  • 手術選擇評估與監控

  • Surgical Guidance

  • Surgical Response

  • Surgical Resistance

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提供多項癌症運用:CSV 抗體、CTC 臨床應用(1)

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提供多項癌症運用:CSV 抗體、CTC 臨床應用(1)

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CTC檢測成功發現及捕捉不同癌症之實例(1)

Cell-Surface Vimentin as Novel Epithelial-Mesenchymal 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

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

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CTC檢測成功發現及捕捉不同癌症之實例(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

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

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CTC檢測成功發現及捕捉不同癌症之實例(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™循環腫瘤細胞基因突變 螢光原位雜交探針偵測

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

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mutaFISH™ 靈敏度與dPCR, Nanostring, NGS之比較

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

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III. 懷慷醫事檢驗所WELLCONN DIAGNOSTICS (精準醫療檢測服務)

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CytoQuest™檢測流程

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CytoQuest™ CR
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檢測人員具備專業證照

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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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懷慷客戶群

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CTC 循環腫瘤細胞檢測服務(1)

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CTC 循環腫瘤細胞檢測服務(2)

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