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TaiMed Biologics, Inc.
March 3, 2021
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TaiMed Biologics
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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
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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$0.71 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
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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)
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Building Pipeline and Work with Business Partners
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Trogarzo Sales through Marketing Partners
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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
Jan 2021 - First long acting monthly injection small molecule combination
MilestonesIbalizumab (TMB-355)
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• 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
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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-370Bispecific Antibody
long acting and board coverage
TMB-380 VRC07-523LS
long acting and board coverage
mAb Bi-specific
R&D Operations Update - 2021
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• 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.
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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.
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Sales updateSlides from Theratechnolgies
(Marketing Operations)2021.3
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181818
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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 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$1B)
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Quarterly Revenue and Gross Margin
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
0
50,000
100,000
150,000
200,000
250,000
300,000
2018Q2 2018Q3 2018Q4 2019Q1 2019Q2 2019Q3 2019Q4 2020Q1 2020Q2 2020Q3 2020Q4
Revenue Gross Margin % of Gross MarginUnit: NT$ thousands
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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
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Commercial Production through External and Internal Capabilities
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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
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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
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Taimed’s Internal Manufactruing Facility
Status: Started production operation for GLP and GMP supplies
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Thank YouQ & A
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