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