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, HsinChu Branch, Taiwan • Manufacturing Operations • QA/QC • Supply Chain Management TaiMed Biologics USA in Irvine, CA, USA • Clinical • Regulatory • Business Development 2
Financial Status 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) 3
Fundraising History 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 4
TROGARZO (ibalizumab) – Approved in US and EU • 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 5
Milestones Ibalizumab (TMB-355) • 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 7
Building Pipeline and Work with Business Partners 8
Our Pipeline with Unique Product Profiles 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) 1 St long Acting mAb HIV drug (biweekly injection) Trogarzo (IV Push) long acting TMB-365 (target monthly injection) long acting and board TMB-Bispecific coverage long acting and board TMB-VRC07-523LS coverage mAb Bi-specific 9
New Licensing for VRC07-523LS • Licensed from National Institute of Allergy and Infectious Diseases (NIAID) of US NIH on 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 10
R&D Operations Updated in 2020 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 11
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. 12
Trogarzo Sales through Marketing Partners 13
Slides from Theratechnolgies (Marketing Operations) 14
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Theratechnologies Partnership North American Agreement European Agreement Date of agreement March 18, 2016 March 6, 2017 12 years from approval (country-by-country Term 12 years from FDA approval basis) 52% (57% of annual sales exceeding US$50M Transfer Price 52% of Net Sales in European Territory Payment at signature US$1M (cash) US$3M (common shares) US$5M (cash – payable one year after US$4M (common shares) Upfront and launch launch) US$5.5M (cash – payable through an milestone US$5M (cash – payable once EU sales reach increase in transfer price) US$50M) US$3M (Intramuscular administration Development milestones 50% of European clinical trial costs (if any) approval) Up to US$207M upon reaching various sales Up to US$80M upon reaching various sales Commercial milestones levels (up to US$1B) and label expansion levels (up to US$1B) objectives 17
TaiMed Biologics Inc. Quarterly Revenue and Gross Margin Revenue (NT$ thousands) Gross Margin (NT$ thousands) ％ of Gross Margin 300,000 60.00% 250,000 50.00% 200,000 40.00% 150,000 30.00% 100,000 20.00% 50,000 10.00% 0 0.00% 2018Q2 2018Q3 2018Q4 2019Q1 2019Q2 2019Q3 2019Q4 2020Q1 18
TaiMed Biologics Inc. 2019 Q1 vs. 2020 Q1 Operating Performance 300,000 250,000 200,000 150,000 100,000 50,000 0 Revenue (NT$ thousands) Gross Margin (NT$ thousands) Operating Gain (Loss) (50,000) (100,000) 2019Q1 2020Q1 19
Commercial Manufacturing Strategy 20
Commercial Production through External and Internal Capabilities 21
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 22
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 23
Taimed’s Internal Mfg Facility (Zhubei Facility) Status: Utility and equipment IOQ are near completion All key talents are onboard to operate the facility 24
Thank You Q & A 25
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