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Abnova — Interim / Quarterly Report 2019
Aug 20, 2019
52384_rns_2019-08-20_7873050e-1cb9-486f-bd3f-03f4ac583fb6.pdf
Interim / Quarterly Report
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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
- 2019年第二季&上半年財務成果
✓ 亞諾法在精準醫療市場的布局
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日本-上元株式会社
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台灣-懷慷醫事檢驗所
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✓ 亞諾法進軍細胞治療領域
✓ 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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2019年第二季及上半年合併損益表
| In NT$K | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Q2‘19 | % | Q2‘18 | % | H1‘19 | % | H1‘18 | % | H1 YOY | |
| 營業收入 | 103,591 | 100% |
114,246 | 100% |
212,172 | 100% |
223,617 | 100% |
-5% |
| 營業成本 | (59,721) | -58% | (64,620) | -57% | (125,624) | -59% | (129,012) | -58% | -3% |
| 未實現銷貨毛利 | - | 0% | - | 0% | - | 0% | 4,175 | 2% |
-100% |
| 營業毛利 | 43,870 | 42% |
49,626 | 43% |
86,548 | 41% |
98,780 | 44% |
-12% |
| 營業費用 | (45,306) | -44% | (43,595) | -38% | (90,616) | -43% | (87,493) | -40% | 4% |
| 營業利益 | (1,436) | -2% | 6,031 | 5% |
(4,068) | -2% | 11,287 | 4% |
-136% |
| 營業外收入及支出 | 2,374 | 3% |
5,407 | 5% |
3,133 | 2% |
8,231 | 4% |
-62% |
| 稅前淨利 | 938 | 1% |
11,438 | 10% |
(935) | -1% | 19,518 | 8% |
-105% |
| 稅後淨利 | 2,503 | 3% |
12,930 | 11% |
634 | 1% |
21,166 | 9% |
-97% |
| 基本每股盈餘 | 0.04 | 0.21 | 0.01 | 0.35 |
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產品別營收分析
In NT$K
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2019 Jan-Jun
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450,000
400,000
81,086
350,000
23%
43,617
300,000
59,618
250,000
200,000 4%
48,755
9,362
150,000 57%
33,406
241,702
100,000
16%
120,649
50,000
0
2018 2019 Jan-Jun
抗體及試劑 蛋白質 檢測儀器 其他
抗體及試劑 蛋白質 檢測儀器 其他
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研發費用分析
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研發費用
In NT$K
15%
14% 14%
30,000
14%
13%
13%
29,000
28,653 29,087
12%
11%
27,968
11%
28,000
10%
27,000
9%
8%
26,000
25,953
7%
25,000 6%
2017.H2 2018.H1 2018.H2 2019.H1
金額 NT$'K 佔比 %
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CytoQuest™ CR & 循環腫瘤細胞陽性富集與收集系統
CytoView™ Integration 整合AI人工智慧影像分析系統
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LiquidCell™ Negative Enrichment Cell Isolation System 陰性富集細胞分離與回收系統
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試劑及套組 LiquidCell™
Depletion Kits
Fluorescent Detecting Antibodies
| Catalog ID | Prodcut Name | ||||||||||
| DM0006 | CytoQuest™ Epithelial Cell Kit | ||||||||||
| Specialty-Coated Glass Slide | |||||||||||
| Catalog ID | Prodcut Name | ||||||||||
| DS0001 | SuperSlide™ | ||||||||||
| Catalog ID | Prodcut Name |
|---|---|
| DH0051 | ASGPR1 monoclonal antibody (FITC) |
| DH0054 | CD276 monoclonal antibody (Alexa 647) |
| DH0055 | CD276 monoclonal antibody (Alexa 647) |
| DH0052 | CD276 monoclonal antibody (APC) |
| DH0053 | CD276 monoclonal antibody (APC) |
| DH0075 | CD44 monoclonal antibody (APC) |
| DH0072 | CD45 monoclonal antibody (Alexa 647) |
| DH0044 | CD45 monoclonal antibody (PE) |
| DH0060 | CDX2 monoclonal antibody (FITC) |
| DH0073 | CDX2 monoclonal antibody (FITC) |
| DH0071 | Cell-Surface Vimentin (CSV) monoclonal antibody (Alexa 488) |
| DH0043 | Cell-Surface Vimentin (CSV) monoclonal antibody (FITC) |
| DH0074 | EpCAM monoclonal antibody (Alexa 488) |
| DH0045 | EpCAM monoclonal antibody (FITC) |
| DH0063 | FOLR1 monoclonal antibody (FITC) |
| DH0076 | PLS3 monoclonal antibody (Alexa 647) |
| Catalog ID | Prodcut Name |
|---|---|
| DU0007 | Cell Dissociation Media |
| DM0007 | Pan Blocking Kit |
| DU0008 | Leukocyte Aggregation Inhibitor |
Cell Staining Dyes
| Catalog ID | Prodcut Name |
|---|---|
| U0333 | Calcein AM |
| U0331 | DAPI |
| U0334 | Hoechst 33342 |
| U0332 | Propidium Iodide |
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- II. 日本 上元株式会社
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檢測服務-ACTN4 IHC & FISH Services
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循環腫瘤細胞檢測服務
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亞諾法集團檢驗服務客戶群
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生技/製藥公司 抗體免疫療法 細胞免疫療法 學術研究機構&醫院 癌症門診/檢驗機構 癌症檢測 細胞療法 監控 光動力療法 轉移 治療決策 抗藥性 16
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膀胱癌人體臨床試驗IRB 循環腫瘤細胞-癌症早期檢測
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- III. 台灣 懷慷醫事檢驗所
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循環腫瘤細胞檢測服務
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精準醫療-次世代基因定序
FFPE Tumor Tissue DNA
Circulating Tumor DNA
Germline Genetic DNA
Circulating Tumor Cell
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遺傳性基因檢測服務
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懷慷檢驗服務客戶群
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生技/製藥公司 抗體免疫療法 細胞免疫療法
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學術研究機構&醫院 癌症門診/檢驗機構 癌症檢測 細胞療法 監控 光動力療法 轉移 治療決策 抗藥性
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IV. 亞諾法細胞治療
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方案一– 泛腫瘤表面抗原
結合低劑量化療與IL-12, 增強CD8+ T細胞中NKG2D的表現 量與泛腫瘤細胞中NKG2D配體的表現量
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Inducible
Constitutive
NKG2D
NKG2D
Expression
Expression
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CD8+ T 細胞NKG2D 誘導、定位與實體腫瘤抑制
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NKG2D is specifically induced on CD8+ T cells by Doxorubicin + IL-12 but Not Other Types of Immune Cells
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NKG2D Induction of NKG2D Expression by Doxorubicin + IL-12 Enhanced Immune Cell Localization in Solid Tumor
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CD8+ T cell Localization in Solid Tumors is dependent on NKG2D
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Inhibition of Solid Tumor Growth and Metastasis by Doxorubicin + IL-12 is dependent on NKG2D
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Hu J, et al., Molecular Cancer 2014; 13(34): 1-13
實體腫瘤NKG2D 配體的誘導與表現
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As Tumor Malignancy Increases, the NKG2D Ligands in Tumors Decreases
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Chemotherapeutic Agents Can Induce NKG2D Ligand on Tumor Cells in Vitro , Not In Vivo
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Combination of a Few Specific Chemotherapeutic Agents and IL-12 Can Increase NKG2D Ligand in Solid Tumors, ie Doxorubicin, Cyclophosphamide, Cisplatin
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Doxorubicin + IL-12 Induces Tumor-Specific and Long Lasting NKG2D Ligand Expression
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No NKG2D Ligand Induction in Normal Tissues after Doxorubicin + IL-12 Treatment
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Hu J, et al., Cancer Immunol Res 2017; 5(4): 1-12
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方案二– 腫瘤細胞滲透，腫瘤微環境與腫瘤異質性
結合速溶艾黴素注射劑(Doxorubicin) 與attIL-12基因修飾T細胞 誘導T細胞深入滲透至實體腫瘤中，克服腫瘤免疫抑制微環境
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Secreted IL-12
IL-12
Receptor
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attIL-12
(Membrane
Anchored IL-12)
IL-
IL-12
12
Receptor
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T Cells/Activated Macrophages
T Cells/Activated Macrophages
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CD8+ T細胞深入滲透腫瘤中，進行毒殺腫瘤細胞
• Doxorubicin or IL-12 Alone Attracts CD8+ T cells to Tumor Margins. Only Doxorubicin plus IL-12 Recruit CD8+ T cells to Centers of the Tumors (10mm in diameter)
- Doxorubicin + IL-12 promotes IFN-gamma which boosted CDCL9 and CXCL10 Expression
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Hu J, et al., Clin Cancer Res 2018; 24(2): 1-16
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最新臨床前研究資料中顯示，IL12為抗癌藥物關鍵基因
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Recombinant IL-12 Protein
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Systematic especially hematologic toxicity
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Toxic effects related to secondary production of IFN-gamma and TNF-alpha
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IL-12 Gene Therapy
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Intratumoral IL-12 plasmid injection has low gene transfer efficiency
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Intralesional IL-12 plasmid + electroporation was more effective but not
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applicable for systemic tumors
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Intramuscular IL-12 plasmid + electroporation failed to localize IL-12 product
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Tissue TIL + Inducible IL-12 (Dr. Steve Rosenber, NCI 2010)
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Short responses without IL-12 producing TIL persistence in melanoma
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High serum IL-12 levels and IFN-g associated clinically toxicities
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Peripheral Blood TCR + Inducible IL-12 (Dr. Steve Rosenberg, NCI 2011) - T-cell receptor specific for NY-ESO-1 tumor antigen in sarcoma and melanoma
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Study suspended several weeks after start of the trial which was then terminated.
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4[th] Generation CAR T cell with Inducible IL-12 (Dr. Brentgens, MSKCC)
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MUC-16 CAR T cell with secreting IL-12 against recurrent ovarian cancer
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方案三– 局限細胞因子引發的細胞毒性區域 A 速溶艾黴素注射劑(Doxorubicin) 直接促使IL-12局限於腫瘤中誘導IFN-g 分泌免疫細胞，減緩全身性IFN-g 反應效應與細胞激素釋放綜合症
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Zhu S W, et al., Clin Cancer Res 2007; 13(14): 4525-4260
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速溶艾黴素注射劑(Doxorubicin) 局限強烈IL-12腫瘤內 細胞免疫反應，避免引起身體系統性影響
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Lasek W, et al., Cancer Immunol Immunother 2014; 419-435
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方案四
attIL-12 基因修飾誘導型腫瘤浸潤淋巴細胞可抽取血液製 備，無須透過組織採集
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