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TaiMed Biologics, Inc. March 3, 2021 1

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  • TaiMed Biologics, Inc.

    March 3, 2021

    1

  • TaiMed Biologics

    2

    A publicly traded biotech company focus on the development and commercialization of therapeutics in HIV and COVID-19 infectious diseases

    Corporate Structure:

    TaiMed Biologics, Inc. in Taipei, Taiwan• Corporate Headquarter/Administration• Finance/Accounting• Research & Development(GMP Analytical Lab)

    TaiMed Biologics, HsinChu Branch, Taiwan • Manufacturing Operations• QA/QC• Supply Chain Management

    TaiMed Biologics USA in Irvine, CA, USA• Clinical• Regulatory• Business Development

  • Financial Status

    3

    TaiMed has been a publicly traded company on the Taipei Exchange Emerging Stock Market (stock code: 4147) since 2010

    IPO on Nov 23, 2015 and traded on the Taipei Exchange Market (OTC) Current market cap is approximately USD$0.71 Billion MSCI small cap index since November, 2019 Ruentex hold ~17% of TaiMed. National Development Fund hold ~16% of

    TaiMed Shareholders exceed 33,000 (April, 2020)

  • Fundraising History

    4

    Raised a total of USD$208M through four fundraising rounds :

    • First round (2007-2008) USD$ 30M

    • Second round (2010) USD$ 22M

    • Third round (2014) USD$ 46M

    • Forth round for IPO (2015) USD$110M

    Cash in hand as of 12/31/2020 : USD$34M

    Total shares outstanding : 252,250,000

  • Product Portfolio

    • Commercial Product:• TROGARZO (ibalizumab) for the treatment of MDR HIV patients – Approved in

    US and EU

    • Pipeline:• TMB-365 (HIV) – Long acting antibody from • TMB-380 (HIV) – Broad coverage antibody• TMB-370 (HIV) - Bispecific antibody with dual mode of action• TMB-200 (COVID-19) – Antibody (through equity investment of RenBio)

    5

  • Building Pipeline and Work with Business Partners

    6

  • Trogarzo Sales through Marketing Partners

    7

  • TROGARZO (ibalizumab) – Approved in US and EU

    8

    • Humanized monoclonal antibody being developed for the treatment of multidrug resistant (MDR) HIV-1 infection

    • First HIV treatment approved with a new mechanism of action in more than 10 years

    • First monoclonal antibody for MDR HIV-1• Only ARV that does not require daily

    dosing (infused q2w)• Binds primarily to the second extracellular

    domain of CD4+ T cell receptor, away from MHC II molecule binding sites

    • Prevents HIV from infecting CD4+ T cells while preserving normal immunological function

    https://www.youtube.com/watch?v=rPf9rqBbrNQ

  • Jan 2021 - First long acting monthly injection small molecule combination

  • MilestonesIbalizumab (TMB-355)

    10

    • EMA granted approval of Trogarzo (trade name for ibalizumab) - 9/26/2019

    Germany Market Launch – 9/29/2020

    Rolling launches in Europe is ongoing in 2021

    • FDA granted approval of Trogarzo (trade name for ibalizumab) - 3/6/2018

    US Market Launch – 4/30/2018

    • Completed Phase III trial – 11/2016 (US, TW)

    • Granted US FDA breakthrough designation therapy for MDR patients in IV dosage form – 2/2015

    • Granted US FDA orphan drug designation for MDR patients – 10/2014

  • Our Pipeline with Unique Product Profiles

    11

    產品線 產品特性 臨床前期 臨床一期 臨床二期 臨床三期 上市銷售

    Trogarzo (IV)1St long Acting mAb HIV drug(biweekly injection)

    Trogarzo (IV Push)

    TMB-365 long acting(target monthly injection)

    TMB-370Bispecific Antibody

    long acting and board coverage

    TMB-380 VRC07-523LS

    long acting and board coverage

    mAb Bi-specific

  • R&D Operations Update - 2021

    12

    • Started Phase III study of new mode of administration (IV Push) for

    Trogarzo (March 2019)

    • Started Phase I study of TMB-370 Bi-specific in US (April, 2019)

    • Started Phase I study of TMB-365 in US (November, 2019)

    • Licensing TMB-380 VRC07-523LS from US NIH (October, 2019)

    • Made equity investment in Renbio for the development of COVID-19

    cocktail antibody therapy

  • COVID-19 Neutralizing Antibodies Development project

    • In 2020, we licensed a human antibody (2-7, TMB-200) from Columbia University for the

    treatment of Covid-19. In light of the quick emergence of several variants of the virus and

    the likelihood of continued viral mutation in the viral spike proteins, however, we have

    decided it is prudent to pursue antibody cocktails rather than a single antibody for treatment.

    Accordingly, we suspended internal development of 2-7 and made an equity investment in

    RenBio, who will continue the antibody cocktail development of 2-7 with another antibody of

    their choice for Covid-19 treatment.

    • RenBio was co-founded by Drs. David Ho and Yaoxing Huang, visionary scientists affiliated

    with the Aaron Diamond AIDS Research Center in New York City. The adjustment decision

    made by TaiMed can significantly reduce the cost and risk of internal research &

    development in the future. TaiMed also can provide the related antibodies production support

    for the project if need.

    1313

  • Business Operations Update - 2021

    Settlement Agreement for Royalty

    • On March, 11, 2020, TaiMed Biologics Inc. entered into a complete settlement

    agreement with Genentech Inc. and Biogen Inc. for all disputes of the milestone and

    royalty payments under the 1998 and 2007 License Agreement.

    • After fulfilling the agreed terms of settlement, the License Agreement will be

    terminated. TaiMed have no obligation for any payments after that.

    • There is a significant positive impact on the Company’s financials for a coming

    decade.

    14

  • 15

    Sales updateSlides from Theratechnolgies

    (Marketing Operations)2021.3

  • 1616

  • 171717

  • 181818

  • 19

    Theratechnologies Partnership

    North American Agreement European Agreement

    Date of agreement March 18, 2016 March 6, 2017

    Term 12 years from FDA approval 12 years from approval (country-by-country basis)

    Transfer Price 52% of Net Sales 52% (57% of annual sales exceeding US$50M in European Territory

    Payment at signature US$1M (cash) US$3M (common shares)

    Upfront and launch milestone

    US$4M (common shares)US$5.5M (cash – payable through an increase in transfer price)

    US$5M (cash – payable one year after launch)US$5M (cash – payable once EU sales reach US$50M)

    Development milestones US$3M (Intramuscular administration approval) 50% of European clinical trial costs (if any)

    Commercial milestonesUp to US$207M upon reaching various sales levels (up to US$1B) and label expansion objectives

    Up to US$80M upon reaching various sales levels (up to US$1B)

  • 20

    Quarterly Revenue and Gross Margin

    0.00%

    10.00%

    20.00%

    30.00%

    40.00%

    50.00%

    60.00%

    0

    50,000

    100,000

    150,000

    200,000

    250,000

    300,000

    2018Q2 2018Q3 2018Q4 2019Q1 2019Q2 2019Q3 2019Q4 2020Q1 2020Q2 2020Q3 2020Q4

    Revenue Gross Margin % of Gross MarginUnit: NT$ thousands

  • 21

    Operating Performance

    (800,000)

    (600,000)

    (400,000)

    (200,000)

    0

    200,000

    400,000

    600,000

    800,000

    Operating Revenue Operating Profit Operating loss Net loss

    2018 2019 2020

    Unit: NT$ thousands

  • Commercial Manufacturing

    22

  • Commercial Production through External and Internal Capabilities

    23

  • Commercial Manufacturing Update - 2021

    • Production schedule secured to ensure continued commercial supplies

    • Production yield (titer) has improved in recent batches at Wuxi Biologics

    • Process validation completed at SBL and the regulatory filing in the US and EU planned in 3Q 2021

    24

  • Internal Manufacturing Capability - 2021

    cGMP Biologics Manufacturing Facility

    Process Development and Manufacturing

    QC Release and Quality Assurance

    Global Supply Chain Management

    3rd Party Contract Manufacturer Management

    25

  • Taimed’s Internal Manufactruing Facility

    Status: Started production operation for GLP and GMP supplies

    26

  • Thank YouQ & A

    27