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ADIM Investor Presentation 2016

Nov 21, 2016

52386_rns_2016-11-21_30ddbdbf-042f-43b4-a2ea-c18198923080.pdf

Investor Presentation

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TWSE 4142

Nov, 2016

Disclaimer

  • The presentation and the relevant information mentioned in this material, including operating performance, financial performance and the business outlook, have been compiled from both internal and external resources.

  • These forward looking statements involve known and unknown risks, uncertainties and other factors, including price variation, competition, global economy, exchange rate movement and market demand, which may cause actual results to differ materially from those implied by such forward-looking statements.

• This Presentation should not be considered as the giving of investment advice by the Company or any of its shareholders, directors, officers, agents, employees or advisers. Each party to whom this Presentation is made available must make its own independent assessment of the Company after making such investigations and taking such advice as may be deemed necessary. In particular, any estimates or projections or opinions contained herein necessarily involve significant elements of subjective judgment, analysis and assumptions and each recipient should satisfy itself in relation to such matters.

  • The forward looking statements expressed in this material reflect the Company’s current view about the future as of today. The Company is not responsible for any updates if there are any changes in the future.

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Contents

Executive Summary

Experienced and Solid Mgmt Team Top in Asia

Strategy for Future Growth

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Contents

Executive Summary Experienced and Solid Mgmt Team Top in Asia Strategy for Future Growth

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The Most Qualified Vaccine Provider in Asia

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Founded in 1965 Ticker: 4142 TT 278 Full Time Employees Dedicated research, development and manufacturing of human vaccine and aseptic PFS Filling Revenue of NT$290mn/156 mn in 2015/1H2016 Market cap of US$171 mn (as of 2016/10/24) Headquarters: Taichung, Taiwan cGMP Vaccine Facility: Certificate: EU, China, Korea and Taiwan cGMP obtained. Capacity: 25mn doses/yr (flu) cGMP PFS Filling Facility: Certificate: USA, EU and Taiwan cGMP obtained. Capacity: 25mn doses/yr

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Value Creation – Adimmune Style

  • We are a vertically-integrated, innovative bio-pharma company excel in high-quality human vaccine R&D and

manufacturing, aseptic prefilled syringe filling, multinational

vaccine registration, branding and strategic producing partnership, with a steady revenue stream.

  • We have deep collaboration relationship with national academic institutes (e.g. Academia Sinica, NHRI, DCB, ITRI) and ready to move on to other bio-pharma products.

  • We are the only vaccine provider in Asia that has obtained USA, EU, China, Korea and Taiwan cGMP. And we will obtain Japan cGMP in 2017.

  • Our superior quality is led by > 50 years of experience in cGMP vaccine manufacturing and collaborating with Japan and European MNCs.

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  • Our solid capabilities in high-quality commercial scale human vaccine manufacturing and PFS filling enables us to expand our business to China, Europe, Japan and the US.

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Contents

Executive Summary

Experienced and Solid Mgmt Team

Top in Asia Strategy for Future Growth

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Excellent Leadership

Chi-Hsien Chan, M.D.

Chairman & CEO

  • From 1997, Dr. Chan held several important positions in Taiwan government, including the Minister of Health and Welfare, Chairman of National Health Research Institutes, National Policy Advisor to the President and Senior Advisor to the President.

  • He was the president at Chi Mei Medical Center for 15 years beginning in 1989.

  • Dr. Chan trained as a medical doctor (Yale and Thomas Jefferson, USA), and following clinical practice at Pomona Valley Hospital Medical Center, California, and became the Director of the Department of Surgery at Pomona Valley Hospital Medical Center.

  • Owing to his solid experience in both the private and public sectors, and extensive knowledge of the healthcare industry, Dr. Chan was nominated and elected to be the Chairman of Adimmune, since 2008.

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Experienced and Solid Management Team

Chung-Cheng Liu, Ph.D. General Manager Over 30-yrs experience VP General Director of Industrial Technology Research Institute (ITRI) Ph.D., Biochemistry, Princeton University

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Chin-Chuan Chang, Ph.D. COO, VP of R&D Over 25-yrs experience Scientist, Development Center for Biotech. Ph.D. Chemical Engineering and Material Science, UC Davis

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Chin-Yi Chiu, Ph.D. VP of Quality Assurance Over 25-yrs experience Sector Manager, Bureau of Food & Drug Analysis, TFDA Ph.D. Cell & Mol. Biology, Univ. of Massachusetts

Simon Kao

VP of Business Division Over 25-yrs experience Taiwan General Manager & Greater China Regional Manager, Medtronic EMBA, National Chengchi University

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Peter Pan

General Counsel Over 30-yrs experience General Counsel, Vanguard International Semiconductor Corporation LL.M. University of Pennsylvania

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Vic Chang, CIA

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CFO, Director of Strategic Planning 20-yrs experience Internal Auditing Manager, Special Assistant to Chairman MBA, University of Houston

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Contents

Executive Summary Experienced and Solid Mgmt Team Top in Asia Strategy for Future Growth

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Current Leadership Engineers Transformation

  • Adimmune has over time developed from a vaccine agent to the state of the art cGMP facility with proprietary know-how and intellectual property.

  • Led by Chairman Chan, Adimmune has transformed into a profit and shareholder value focused company and listed on TWSE since 2012. Dr. Chan introduced new management team and started a series of initiatives from innovation to international partnership. It is proved that Adimmune plays an important role in global vaccine and biologic product value chain.

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2016
• TWSE Listed 2015
• PFS facility obtained

Taiwan cGMP 2014 Export vaccine
• Hong Kong flu vaccine antigen to Kitasato
approval obtained Daiichi-Sankyo for
2013 Japan market

Expected to obtain

Supplied 10mn doses Export Flu Flu Vaccine (4
2012
of A/H1N1 vaccine for Vaccine to Strains) approval in
Partnership with
pandemic use Protein Sciences Taiwan
Crucell for European 2011
• Founded Market • Partnership with for US market • PFS facility obtained
• Partnership Techdow for PFS US cGMP
with Kitasato Obtained 2009 filling for EU market
Institute Taiwan cGMP • Total 15 European • China flu vaccine
2008
Vaccine facility countries (1) flu approval obtained
obtained EU cGMP vaccine approval • Taiwan Cell based
2007
obtained Japanese Encephalitis
1992 New Mgmt Team in
• Licensed in EV71 vaccine approval
place leading the
vaccine from NHRI obtained
1965 transformation of
the new Adimmune
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  • PFS facility obtained US cGMP

Note: (1) 15 European countries are including Germany, UK, Italy, Switzerland, Austrial, Ireland, Spain, Portugal, Nederland, Belgium,Luxembourg, Sweden, Norway, Denmark, Finland

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Key Strength

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Solid R&D
Capability
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Global
Value Chain
Partnership
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Strong
Technology
Background
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Scale-up &
Commercial
manufacturing
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Internationalized
Talent Pool
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Key Strength

Solid R&D Capability

  • R&D Track Record: Influenza Vaccine, Pandemic A/H1N1 Vaccine, Japanese Encephalitis Vaccine and Tetanus Vaccine

  • Pipeline: pandemic H7N9/H5N1 Vaccine, Cell-cultured Japanese Encephalitis Vaccine, Enterovirus 71 vaccine, Recombinant Protein Production Platform and therapeutic/diagnostic monoclonal antibody

  • Collaboration for future pipeline: National academic institutes such as Academia Sinica, NHRI, DCB and ITRI

Strong Technology Background

  • Flu vaccine international partner in the past: Kitasato Institute, Japan. Crucell (a J&J company)

  • Obtained Certification: USA, Europe, China, Korea and Taiwan cGMP certificate

  • Expecting Certification: Japan will start inspection process in 2017 (vaccine)

Internationalized Talent Pool

  • Management team captained leading academia institution and renowned MNCs with successful track record

  • Highly professional production line staff with extensive experience from R&D to commercial scale manufacturing

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Key Strength

Scale-up & Commercial manufacturing

Since founded in 1965, Adimmune has supplied:

  • Flu vaccine: 20mn doses

  • A/H1N1: 10mn doses

  • Japanese Encephalitis: 21mn doses

  • Tetanus: 16mn doses

  • Capacity: vaccine 25mn/yr, PFS 25mn/yr

  • Current capacity is sufficient for the growth strategy, no significant Capex needed in next 5 years

  • Strategic Producing Partnership

  • Upstream Partnership: Export 4 strains Flu Vaccine bulk to Kitasato Daiichi-Sankyo for Japan market

  • Downstream Partnership: Collaborate with Techdow for Enoxaparin to export to Europe. Export PFS flu vaccine to Protein Sciences for US market

  • Owing to the nature of bio-pharma industry, once a strategic producing partnership is established, relationships necessarily remain long term

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Top Flu Vaccine provider in Asia

  • Adimmune is the most qualified and internationally recognized flu vaccine provider/ PFS filling facility in Asia, with ample capacity
Company Country Flu Vaccine Flu Vaccine Flu Vaccine Flu Vaccine Flu Vaccine Flu Vaccine
cGMP Obtained Capacity
(mn)
EU USA Japan China Korea
Adimmune Taiwan √(1) 25
BioFarma Indonesia 4
IVAC Vabiotech Viet Nam 1
GPO Thailand 5
Panacea Biotec SII India 10
Green Cross Korea
Biken Japan 10
Chemo-Sero-Therapeutic Research Institute Japan 10
Denka Seiken Japan 10
Kitasato Daiichi Sankyo Japan 12
Hualan China 25
Sinopharm (Tiantan) China 4
Sinovac China 10
Tianyuan China 15
  • (1) Japan will start inspection in 2017

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Contents

Executive Summary Experienced and Solid Mgmt Team Top in Asia

Strategy for Future Growth

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Growth Strategy

Diversify Multiple International Technology Products Marketing

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  • Existing technology to maintain high-quality, high throughput manufacturing

  • New technology for new products

  • New technology to reduce risk of contamination

  • New technology to reduce time-to-market for emergency outbreak

  • New product to respond to the needs of next generation vaccine

  • • New product to fulfill unmet medical needs

  • New product to enrich product mix and create new revenue source New product to tackle new markets

  • Achieve market access though cGMP certification from different countries/region

  • • Solid track record to become long term strategic producing partner with US, Japan and Europe MNCs

  • Adimmune branded product for Europe and China

  • Improve utilization rate

  • Become the gateway into China and major healthcare countries

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Diversify Technology

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Egg Based Process

  • -Flagship technology of Adimmune

  • -Mature and stable

  • -Flu vaccine mass production

Recombinant Protein

  • -Months faster than Egg-based and cell-culture process to tackle outbreak

-Consistent high quality and competitive manufacturing costs

-Flu vaccine

Serum Free Cell Culture

  • -Risk free from Mad cow disease

  • -Easy to scale up with Bioreactor

  • -Flu, Japanese Encephalitis, and Enterovirus vaccine, Monoclonal antibody

Advance Aseptic PFS Filling Technology

-Avoid cross contamination

-Protein product need full aseptic environment

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Multiple Products

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Products in 2016 Products by 2018 Future Products
Flu vaccine (3 strains) Flu vaccine (3 strains)
Existing Products
Flu vaccine (4 strains)
Avian Flu pandemic vaccine
Mouse brain-derived Japanese Cell Cultured Japanese Monoclonal Antibodies
Encephalitis vaccine Encephalitis vaccine
Protein Drugs
Tetanus Vaccine Tetanus Vaccine
Tuberculin Tuberculin Other New Vaccines & Products
Enterovirus 71 vaccine
Bacillus Calmette-Guerin
Vaccine
New Strategic Producing
Enoxaparin Sodium (PFS) Partner
U.S. Flu vaccine (PFS)
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  • Through its diligence in R&D, more products will enter domestic and global markets in the following 3 years.

  • By 2018, new products: 4 strains Flu vaccine, Cell cultured Japanese Encephalitis vaccine, Enterovirus 71 vaccine will hit the market. As well as PFS filling product Enoxaparin Sodium Injection and Flu vaccine for Protein Science.

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Global Market Expansion

  • European Union Japan USA

  • China

  • • Flu Vaccine (4 Strains) • PFS Enoxaparin Sodium • Flu Vaccine (3 Strains) • Flu Vaccine (4 Strains) • PFS Flu Vaccine (4 Strains) Injection Taiwan • Flu Vaccine (4 Strains) • Enterovirus 71 vaccine • Cell Cultured Japanese Encephalitis vaccine

  • • Tetanus vaccine • Tuberculin

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— Europe 歐洲Phase III Clinical trial Quadrivalent Flu vaccine

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Multi-Center Clinical Trial Non-inferiority-trial

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2016 2017 2018 10/15 12/30 06/30 08/30 09/01 09/01 試 試 觀 結 藥 藥 1,050人 • 驗 驗 察 案 證 證 Ghent • Antwerpen 執 收 完 報 申 Decentralized 核 行 案 成 告 請 發 收案期 觀察期 審查期 11/07 1,050人 • Taipei 驗 執 行

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AdimFlu-S (QIS)  Quadrivalent Influenza vaccine

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FDA approves Protein Sciences U.S. quadrivalent flu vaccine

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Final bulk : US Pearl River US Meriden Japan Gifu (Unigen Corp.) Aseptic Filling: Adimmune Corp.

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CMO for Quadrivalent Flu vaccine Aseptic filling

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2014 2015 2016
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Q4

Q4

1月

Q4

Q4

1月

03/24~4/02

10/07

























FDA




審查期

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FLUBLOKQUADRIVALENT

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Permit license

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http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm524738.pdf

China CMO for Aseptic filling

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Techdow
API
Adimmune Corp.
License Enoxaparin
Logistics Center
歐洲各國
波蘭
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Enoxaparin, the new favorite Antithrombotic drug

低分子量肝素Enoxaparin 肝素Heparin
來源 自肝素分離或是
肝素降解
自腸粘膜或
牛肺臟中提取
抗凝血機轉 主要抑制凝血因子factor Xa
次要抑制凝血因子factor IIa
增加抗凝血酶antithrombin III的
作用
應用 急性靜脈血栓
急性冠脈綜合症(心絞痛、心肌梗塞)
手術後血栓形成
抗凝血和抗血栓
治療瀰漫性血管內凝血
透析、手術中抗凝血處理
優點 抗血栓的作用強
生物利用度高
出血危險少
減少使用之肝素副作用(如易出血、血
小板減少和骨質疏鬆等)
市場 低分子肝素是全球抗血栓藥物
售排名前五位的藥品之一
主要供應商為Sanofi(73%市佔)、其他
為Pfizer、GSK、LEO
3.6億劑/年in Europe

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CMO for Enoxaparin Aseptic filling

2013 2014 2015 2016 2017 Q4 Q4 Q4 Q1 7 月 11 月 3 月 7 月 1~12 月 試 安 歐 歐 歐 國 藥 藥 依 驗 定 盟 盟 盟 光 商 商 合 批 性 NDA NDA EMA獲 S.P P.T 約 生 試 啟 送 來 歐 獲 獲 陸 產 驗 動 件 台 盟 波 歐 續 查 EMA 蘭 盟 出 效期安定性資料建立 廠 GMP 藥 藥 貨 查 證 證 廠 認 證 審查期

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Product Pipeline

Completed In Progress Up coming Lab Animal Phase I Phase II Phase III NDA Development Trial H7N9 Avian Flu Vaccine EV71 Vaccine Cell Cultured JEV Recombinant Flu Vaccine EV71Monoclonal Antibody Zika Vaccine Dengue Vaccine

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Our Commitment to Shareholders

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  • To maintain our position as the leading vaccine and PSF filling solution provider in Asia.

  • To become the gateway to China and Global Market.

  • To deliver a consistent high quality with proprietary technology, and to fully utilize our capacity.

  • We also pledge that our primary focus will be the maximization of returns to our shareholders via the potential of our promising growth strategy.

  • We believe in high standards of corporate governance and investing in our employees and the communities where we do business.

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Thank you!

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