TaiMed Biologics, Inc. May 2020 1 Corporate Structure TaiMed - - PowerPoint PPT Presentation

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TaiMed Biologics, Inc. May 2020 1 Corporate Structure TaiMed - - PowerPoint PPT Presentation

Dec 24, 2023 707 likes •970 views

TaiMed Biologics, Inc. May 2020 1 Corporate Structure TaiMed Biologics, Inc. in Taipei, Taiwan Corporate Headquarter/Administration Finance/Accounting Research & Development GMP Analytical Lab TaiMed Biologics,

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TaiMed Biologics, Inc.

May 2020

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Corporate Structure

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  • 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
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SLIDE 3

Financial Status

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  • 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$0.77 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)
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SLIDE 4

Fundraising History

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  • Raised a total of USD$208M through four fundrasing 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 3/31/2020 : USD$40M
  • Total shares outstanding : 252,198,000
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TROGARZO (ibalizumab) – Approved in US and EU

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  • 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

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Milestones Ibalizumab (TMB-355)

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

Planning to launch in Germany - H2, 2020

  • 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
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SLIDE 8

Building Pipeline and Work with Business Partners

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Our Pipeline with Unique Product Profiles

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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-Bispecific long acting and board coverage TMB-VRC07-523LS long acting and board coverage mAb Bi-specific

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New Licensing for VRC07-523LS

  • Licensed from National Institute of Allergy and Infectious Diseases (NIAID) of US NIH
  • n October 2, 2019
  • A world-wide, non-exclusive license under the NIAID Patent Rights to develop and

commercialize the VRC07-523LS broadly neutralizing antibody for providing an effective treatment against HIV

  • TaiMed will combine with VRC07-523LS and TMB-Bispecific Antibodies for drug

development targeting as the HIV second-line treatment therapy in the future

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R&D Operations Updated in 2020

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

Trogarzo (March 2019)

  • Started Phase I study of Bi-specific in US (April, 2019)
  • Started Phase I study of TMB-365 in US (November, 2019)
  • Licensing VRC07-523LS from US NIH (October, 2019)

phase I study in progress from 2018

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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.

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Trogarzo Sales through Marketing Partners

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Slides from Theratechnolgies (Marketing Operations)

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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 milestones Up to US$207M upon reaching various sales levels (up to US$1B) and label expansion

  • bjectives

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

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SLIDE 18

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TaiMed Biologics Inc.

0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 50,000 100,000 150,000 200,000 250,000 300,000 2018Q2 2018Q3 2018Q4 2019Q1 2019Q2 2019Q3 2019Q4 2020Q1

Quarterly Revenue and Gross Margin

Revenue (NT$ thousands) Gross Margin (NT$ thousands) ％ of Gross Margin

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TaiMed Biologics Inc.

(100,000) (50,000) 50,000 100,000 150,000 200,000 250,000 300,000

Revenue (NT$ thousands) Gross Margin (NT$ thousands) Operating Gain (Loss)

2019 Q1 vs. 2020 Q1 Operating Performance

2019Q1 2020Q1

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Commercial Manufacturing Strategy

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Commercial Production through External and Internal Capabilities

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Commercial Manufacturing Status

  • Production schedule secured to ensure continued commercial supplies
  • Production yield (titer) has improved in recent batches
  • Tech transfer and process scale-up at SBL is ongoing

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Taimed Biologics Zhubei

  • cGMP Biologics Manufacturing Facility
  • Process Development and Manufacturing
  • QC Release and Quality Assurance
  • Global Supply Chain Management
  • 3rd Party Contract Manufacturer Management

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Taimed’s Internal Mfg Facility (Zhubei Facility)

Status:

 Utility and equipment IOQ are near completion  All key talents are onboard to operate the facility

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Thank You Q & A

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