1. TaiMed Biologics, Inc.
December 5, 2018

2. 2019 R&D Operations Submit Trogarzo for EMA regulatory approval
Granted accelerated review
Deferred pediatric investigation plan
Phase III (label extension)Trogarzo IV push (2019 Q1)
Pre IND meeting with FDA for TMB-365 (2019 Q1)
Phase I start of Bi-specific in US (2019 Q1)
Continuing phase 1 of TMB-607 in US
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3. Ttogarzo sales in US
Thera expects to complete the private and public insurance coverage in 2018 (80% in November, 2018)
In-line with long-term expectations (5,000 target), but a little slow in the beginning of first 1-2 years for the product launch
Trogarzo should mimic the uptake of other successful HIV product launches.
Based on Theratechnologies’s sales forecast,
From the short-term perspective, the sales run rate of Trogarzo should surpass that of EGRIFTA by the end of the first year of commercialization.
Looking at the longer term, Trogarzo peak sales could be 5x or more than those of EGRIFTA
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4. Timeline Total Investment NT$1B Ground-breaking ceremony – June 2017
Topping-out ceremony – Nov 2017
Obtained building use license – Feb 2018
Initiated facility utility engineering and interior construction project – Mar 2018
Facility completion – early of 2019.
Total Investment NT$1B
9/2017
10/2017
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4/2018

5. Another CMO Plan
Considering in the sales in US、EU and other countries, in addition of competition of production cost, TaiMed is processing the Contract Manufacturing Operation （CMO） Plan. Details will be announced at the appropriate timing.