Mallinckrodt Plc (MNKT)

[Trend-Setter]

BIOVIE
Pioneering therapies for advanced liver disease
Non-confidential investor presentation | December 2018

***A new treatment option is emerging for refractory ascites
Based on investigative studies in Italy and Australia
***Terlipressin (BIV201’s active agent) is approved in 40+ countries for
treating related liver cirrhosis complications (HRS & BEV*)

***BIV201 is a new drug candidate in the US
Terlipressin is not available in the US or Japan

***Currently in US phase 2 clinical
trials; seeking to replicate
European & Australian
investigative study results

***BIV201 offers advantages in 40+ countries where
Terlipressin is already approved
Targeting improved efficacy and safety compared to IV bolus dosing

***Clinically de-risked development program
The same therapy that is currently in use in Italy and Australia

***US patent protection
through 2036
***Filed for patents in Japan,
China & Europe
***US Orphan Drug designations for
both ascites and HRS to enable 7
years of market exclusivity
***FDA Fast Track status; will seek
Breakthrough Therapy designation

https://www.biovieinc.com/wp-content/uploads/2019/01/BioVie-Non-Conf-Deck_Dec_2018.pdf