Tty Biopharm Company Limited · TPEX:4105
Tty Biopharm — Investor Presentation (March 2017)
47 slides from Tty Biopharm's investor presentation, March 2017
Slide 1: March, 2017
March, 2017
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, a
Slide 3: Liposomal & microsphere depot platform technologies
We have been striving to extend liposomal & microsphere depot platform technologies for treatment of various diseases. Our Target is to improve health and quality of life through innovative, cost-effective therapeutics and specialty drugs. Our focus is on the “Unmet Medical Needs” in challenging dis
Slide 4: Company Overview
Company Overview Product Strategy as ee Product Pipeline EE as Manufacture Facilities Successful Product Categories a es In Progress Status Biotech Success WV ei WPT BRERA
Slide 5: 2016 NTD 3.80 Billion, USD 117 Million
2016- NTD 3.80 Billion, USD 117 Million 508 (March, 2017)
Slide 6: TTY Biopharm global leader in Super-Generic Drugs and novel bio-drugs
TTY Biopharm is a global leader in Super-Generic Drugs and novel bio-drug development with strong growth potentials (targeting for 20% sales CAGR in 2014-19). TTY is Taiwan’s largest biotechnology conglomerate with the most completed biotechnology products pipeline including oncology drugs, new
Slide 7: PharmaEngine (19.30%) CY Biotech (27.54%)
智擎生技 創益生技 PharmaEngine (19.30%) CY Biotech (27.54%)
Slide 8: Technology platforms and CMO/CDMO capabilities
A [ Commercial | Capabilities , \ | CMO/CDMO } Liposome | Technology Platform J | | f Microsphere\ / i. Depot }| y Process i } | Development}, Platform y | and Scale-up | J \ Engineering / NX A
Slide 9: Company Overview
Company Overview Product Strategy Product Pipeline EE _— Manufacture Facilities Successful Product Categories In Progress Status Biotech Success
Slide 10: Product Strategy
Product Strategy Trends for Pharmaceutical Industry Market Scope (Risk) Ar New Derivatives Special Formulation New Combination (Technology Platform/ Target Therapy) New Indication New Formulation = fGeneic | « Entry Barrier (Profit)
Slide 11: Pegylipo (Caelyx II) and CMO pricing
* We had agreement in Feb. 2017 that the CMO price would be similar as 2016. * Pegylipo (Caelyx II) Leishmaniasis、Concurrent renal toxicity invasive bacterial infection、 The infected bursa meningitis HIV patients、Systemic Fungal Infection Multidrug-resistant Gram-negative Col103 Bacteria Serious Inf
Slide 12: Col103
Multidrug-resistant Gram-negative First Choice Col103 Bacteria Serious Infection 150 Formulation Irreplaceable Option, TWNIH
Slide 13: Source: Thomson Reuters Mar./2017
Source : Thomson Reuters Mar./2017
Slide 14: Specialty - Lipo-Amy
Specialty- Lipo-Amy Global Market: USD$440 Million Target:Worldwide 35~50% Concurrent renal The infected bursa Leishmaniasis toxicity invasive meningitis HIV bacterial infection patients Systemic fungal infection Uitte eng “MOHESUESAL sxmeeEmA HORTR MMAR
Slide 15: Specialty - Lupron/Leuprolide
s oe @ é " ee PN "950. Ve, Rts ee ee . sy > Rt? oe On we» Pat ees r 3 "9 6* oe a Management of Prostate Cancer Endomottionts B37 aie FEAR iE Specia Global 2014 Lupron/Leuprolide Market: USD$1.24 Billion Target:Worldwide 20~35% Central Precocious Uterine Fibroids Puberty SLR PATE BR )Vowruni “oe ae e
Slide 16: Specialty - Risperidone Injection
Specialty- Risperidone Injection Indication: Schizophrenia Global market: USD$960 Million Risperidone Beagle in vivo release Risperidone 9-OH-Risperidone ~@ Risperdal Consta_AKZT800 2 -® Risperdal Consta_AKZT800 14) 4-RPO_120523 enn 12 = E 40. = 10 2 } En i: i & I 4 Zz 24 to} 2 10 2 °
Slide 17: Specialty - SPL206
Specialty- SPL206 Indications: @ Acromegaly @ Severe diarrhea/flushing episodes associated with metastatic carcinoid tumors @ Profuse watery diarrhea associated with VIP-secreting tumors Synthesized by TTY TTY synthetic star polymers as a carrier!! RO RO. CH, Oo Oo =H R HY RO OR o* y| OR " Polymer L
Slide 18: Mechanism of LGIA10
Mechanism of LGIA10 GLP-1 and Diabetes Indication: Type Il Diabetes Mellitus Stimulates insulin release Incretin,GLP-1 ) Inhibits glucagon DPP-4 release enzyme inactivates GLP-1 MSG DPP- 4 inhibitors (drugs) block DPP-4 and decrease glucose Lowering of blood glucose
Slide 19: Specialty - Col103
Specialty – Col103 Common Anti- Classification Bacterial Strains Fungus Gram negative MDR-GNB (GNB) CR-GNB Bacterial Gram positive MRSA (GPC) VRE Virus MDR-:multi-drug resistant MRSA: methicillin resistant Staphylococcus aureus CR-: carbapenem resistant VRE: vancomycin resistant Enterococcus 28
Slide 20: Col103
Col103 Global Market: 150M Multidrug-resistant Source: Expert Rev Anti Infect Ther. 2012;10(8):917- 934 Gram-negative Bacteria By Y_tambe - Y_tambe's file, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=49535 Serious Infection 29
Slide 21: Company Overview
Company Overview et ee a ee Product Strategy Ses Product Pipeline Manufacture Facilities Successful Product Categories LP ee In Progress Status Biotech Success
Slide 22: Manufacture Facilities
Manufacture Facilities The only PIC/S GMP certified manufacture sites for high potency oncology, 2008/2013/2016 EMA, 2010/2014 Japan, 2013/2016 US FDA, 2013 Brazil, Australia High standard Validation of Equipment qualification/ Laboratory instruments qualification/ HVAC system/ Water system/ C
Slide 23: Chungli Factory
Chungli Factory a frau i | 71% 6 i RS RB i
Slide 24: Lioudu Factory
Lioudu Factory 72¥ioerus oe BB RS Bm
Slide 25: PMDA (Japan)
PMDA (Japan)
Slide 26: Company Overview
Company Overview eH Product Strategy SS Product Pipeline Ro aa) Manufacture Facilities Successful Product Categories In Progress Status Biotech Success
Slide 27: Singapore Hong Kong Philippines
Singapore Hong Kong Philippines Breast Cancer乳腺癌、Lymphoma惡性淋巴瘤、Soft tissue Sarcoma軟組織肉 瘤、Gastric cancer, GC胃癌、Lung cancer LC肺癌、Ovarian Cancer, OC卵巢 瘤
Slide 28: Nigeria Singapore
Nigeria 、Vietnam、 Singapore
Slide 29: Oncology products and indications
Products 產品名稱 Indications 適應症 Market(s) 行銷地區 Treatment of advanced breast cancer in postmenopausal women. (治療 Anazo 停經後婦女晚期乳癌) (安納柔膜衣錠) Adjuvant treatment of early breast cancer in hormone receptor positive Taiwan、Philippines post-menopausal women who have received 2 to 3 years of adjuvant tamoxifen
Slide 30: 47 oncology product licenses registered in 12 countries
TTY has successfully registered 47 oncology product licenses in 12 countries. Country UFur Oxalip Lipo-Dox Irino Asadin Gemmis Tynen Epicin Thado Anazo Folina Sulfin Total EU Austria 2 2 Thailand 1 1 1 1 1 1 1 7 Philippines 1 1 1 3 Vietnam 1 1 1 2 1 2 1 9 Hong Kong 1 1 1 2 2 3 10 Malaysia 1 1 1 1 1
Slide 31: Anti-infective products and indications
Products 產品名稱 Indications 適應症 Market(s) 行銷地區 Brosym C+S 適用於治療由感受性細菌所引起的下列感染：上、下呼吸道感染、上、下泌尿道 (博益欣) 感染、腹膜炎、膽囊炎、膽管炎及其他腹腔內感染、骨盆發炎、子宮內膜炎及其 Taiwan 他生殖道感染、以及創傷燙傷、手術後之二次感染。 唯一抗感染新療效付芳心要對鮑氏不動桿菌(AB菌)治療效果佳。 Cubicin 1. 治療下列感受性革蘭氏陽性菌引起的複雜皮膚和皮膚組織感染(cSSSI)： (救必辛注射劑) Staphylococcus aureus (包括methicillin-resistant i
Slide 32: Anti-Infectives Portfolio
Anti-Infectives Portfolio nae Cubicin CMS Exacin Brosym New formulated colistin New cephalosporin hee Lipo-AB Flusine Anti-HIV DL7014 and TL7014 Z Qa a o a © 2 © a a o Ss Qa a 2 fa) m Antibiotics, Antifungals, Anti-virus G (+) G() Gt) Broad spectrum Anti-carbapenem resistant Broad spectrum Broad spe
Slide 33: Revenue and R&D expense 2007-2016
Year 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Subject Revenue 1,519,680 1,773,420 2,067,360 1,786,500 2,098,500 2,158,500 2,307,540 2,384,220 2,738,956 3,344,262 (NTD,000) R&D Expense 197,550 200,040 238,650 290,040 384,360 366,750 289,530 283,470 236,398 230,192 (NTD,000) *D&C Resource Tot
Slide 34: Company Overview
Company Overview Product Strategy Product Pipeline Manufacture Facilities Successful Product Categories In Progress Status Biotech Success 7iY¥: Yoru BBE BR
Slide 35: Approval dates and categories
送件日期 預估領證日期 核可類別 Category NPD Code Apply Date Approval Date (Est.) 第二等級醫材 1 2016/6/1 2016/12/13 2017 Class II Medical Device ES0013 2 2017/1/1 2018 新成分新藥 NCE TT7016 3 2016/7/1 2018 新成分新藥 NCE PT2014
Slide 36: Company Overview
Company Overview CXS! i 86M Product Strategy = a am Product Pipeline A. Manufacture Facilities /SP EA i Successful Product Categories In Progress Status Biotech Success
Slide 37: Marketing Development R&D (2017-2021)
(2017-2021) Marketing Development TS-1、Painkyl、Brosym(C+S)、Episil、Lonsurf、Aplidin into peak sale Liposome Doxorubicin into global peak sale Liposome Amphotericin B Risperidone PLGA Complete listing for global Leuprolide Depot (Including China market) Colimycin Regional markets integr
Slide 38: Financial Comparison (Individual)
Financial Comparison (Individual) 2013 2014 2015 2016 Item (Actual) (Actual) (Actual) (Actual) NTD ,000 Amount % Amount % Amount % Amount % Net Sales 2,292,163 100% 2,384,207 100% 2,738,956 100% 3,344,262 100% Gross Profit 1,404,003 61% 1,411,875 59% 1,777,941 65% 2,217,286 66% Operating Expenses -1
Slide 39: Financial Comparison (Consolidated)
Financial Comparison (Consolidated) 2013 2014 2015 2016 Item (Actual) (Actual) (Actual) (Actual) NTD ,000 Amount % Amount % Amount % Amount % Net Sales 3,110,092 100% 2,979,902 100% 3,195,218 100% 3,760,717 100% Gross Profit 2,049,211 66% 1,898,936 64% 2,183,144 68% 2,559,220 68% Operating Expenses
Slide 40: 2014-2015-2016 Net Profit (Individual)
2014-2015-2016 Net Profit (Individual) Eliminated the investment traded out Unit：NTD,000 Year 2014 2015 2016 Season Pretax After Tax Pretax After Tax Pretax After Tax Q1+Q2 95,926 76,156 321,740 281,251 735,949 635,684 Q3+Q4 284,325 219,680 552,446 453,717 696,088 557,640 Total 380,251 295,836 874,1
Slide 41: 2014-2015-2016 Net Profit (Individual)
2014-2015-2016 Net Profit (Individual) Eliminated the investment traded out Unit：NTD,000 Year 2014 2015 2016 Season Pretax After Tax Pretax After Tax Pretax After Tax Q1+Q2 95,926 76,156 321,740 281,251 735,949 635,684 Q3+Q4 284,325 219,680 552,446 453,717 696,088 557,640 Total 380,251 295,836 874,1
Slide 42: Earning Distribution
Earning Distribution Year 2011 2012 2013 2014 2015 2016 Item Yield Rate (%) 0.22 1.25 1.91 2.39 3.86 3.71 P/E 45.00 44.24 41.65 33.23 18.61 21.35 Cash Dividend 0.30 1.40 2.00 2.50 3.50 3.80* Stock Dividend 2.40 0.89 0.67 - - - Total 2.70 2.29 2.67 2.50 3.50 3.80 * Awaiting for shareholder meeting de
Slide 43: Major Investors Holdings 2015
3 Major Investors Holdings 2015 台灣東洋(4105)法人持股走勢圖 1/6→12/31 Shift 140 120 100 3 Majors 80 2.39萬張(9.63%) 60 12/31 ■ 117.50 元 (東洋股價) ↓ 70,000 2,000 8.22萬張(33.09%) 60,000 1,000 50,000 40,000 0 Foreign Investor -1,000 30,000 20,000 -2,000 2.09萬張(8.39%) 12/31 ■ 61,258 張 (外資持股) ■ -62 張 (外資買賣超) ↓ 25,000 2,
Slide 44: Major Investors Holdings 2016
3 Major Investors Holdings 2016 台灣東洋(4105)法人持股走勢圖 1/4→12/30 Shift 140 130 120 110 3 Majors 100 8.19萬張(32.93%) 90 12/30 ■ 102.50 元 (東洋股價) ↓ 73,000 3,000 7.42萬張(29.85%) 70,000 2,000 67,000 1,000 64,000 0 Foreign Investor 61,000 58,000 -1,000 -2,000 6.10萬張(24.54%) 12/30 ■ 65,396 張 (外資持股) ■ 154 張 (外資買賣超
Slide 45: Major Investors 20160104~20170224
3 Major Investors 20160104~20170224 台灣東洋(4105)法人持股走勢圖 2016/1/4→ 140 130 2017/2/24 Shift 120 110 3 Majors 100 8.19萬張(32.93%) 90 02/24 ■ 113.00 元 (東洋股價) ↓ 73,000 3,000 6.95萬張(27.94%) 70,000 2,000 67,000 1,000 64,000 0 Foreign Investor 61,000 58,000 -1,000 -2,000 6.10萬張(24.54%) 02/24 ■ 61,993 張 (外資持股)
Slide 46: Government & Insurance Holdings
Government & Insurance Holdings Holdings April/2015 April/2016 Institution 持有股數Stocks 持股比例% 持有股數Stocks 持股比例% Insurance Company 4,880,800 1.96% 11,339,000 4.56% Government Funds 817,021 0.33% 21,177,843 8.52% Total 5,697,821 2.29% 32,516,843 13.08% Insurance Company & Government Funds Holdings 政府基金 保
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