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1 Pioneering therapies for advanced liver disease Non-confidential investor presentation | September 2018

Pioneering therapies for advanced liver disease · Terlipressin is already approved Targeting improved efficacy and safety compared to IV bolus dosing IV bolus dosed terlipressin

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1

Pioneering therapies for advanced liver diseaseNon-confidential investor presentation | September 2018

2Forward-looking statements

This document contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation

Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie’s actual results and experience to differ

materially from anticipated results and expectations expressed in these forward looking statements. BioVie has in some cases identified

forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends,"

"goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from

those expressed in forward-looking statements are BioVie’s need for, and the availability of, substantial capital in the future to fund its

operations and research and development. Other risks are that BioVie’s compounds may not successfully complete pre-clinical or clinical

testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of

these risk factors is included in BioVie’s filings with the Securities and Exchange Commission. You should not place undue reliance on any

forward-looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such forward-looking

statements that may be made to reflect events or circumstances after the date of that these slides are posted to BioVie’s website or to

reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

3BioVie (BIVI) objective

To become the global leader in developing effective drug therapies for patients with advanced liver cirrhosis who:• Are frequently hospitalized with life-threatening complications

• Experience a miserable quality of life

• Do not have palatable options with very high mortality rates

Our first target is ascites, the accumulation of fluid in the abdomen. It’s a common and serious complication of advanced liver cirrhosis, leading to life-threatening health problems

4

$250M+

Projected BIV201 US sales

for refractory ascites (50%

penetration of $500M US mkt)

Why BioVie?

20,000

US patients targeted for

BIV201 therapy

0/0

Number of FDA-approved drugs to treat ascites;

Number of direct competitors

Ph2

In phase 2a clinical trial; FDA

Fast Track and will seek

Breakthrough Therapy status

2036

US Patent expiration;

also 7 years of Orphan Drug

market exclusivity

5Ascites: Poor patient outcomes, primed for disruption

No effective drug therapies are available for refractory ascites patients Patients typically undergo paracentesis

• Withdrawal of 5–10L of ascites fluid from abdomen every 10 days with large bore needle

• Offers short-term relief, but kidneys will eventually “burn out”

• May result in serious medical complications, leaving thousands of patients with no option except liver transplant

6A new treatment option is emerging for refractory ascitesBased on investigative studies in Italy and Australia

• Used for decades in hospitalized patients• Traditionally dosed as 1 - 2 mg IV bolus injection every 4-6

hours (4 to 8 mg/day)• Well understood efficacy and safety profile• Scores of clinical studies and hundreds of publications

Terlipressin (BIV201’s active agent) is approved in 40+ countries for treating related liver cirrhosis complications (HRS & BEV*)

* HRS = Hepatorenal syndrome; BEV = Bleeding esophageal varices

BioVie advisor Dr. Paolo Angeli invented a novel route of administration: continuous infusion terlipressin for ascitesTherapeutic goals:• Improve efficacy and safety• Reduce frequency of cirrhosis complications requiring hospitalization• Reduce cost of care by enabling treatment at home• Restore liver & kidney function, and delay or avoid need for liver transplant

7BIV201 is a new drug candidate in the USTerlipressin is not available in the US or Japan

BIV201 is continuous infusion terlipressin via ambulatory pump

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

Projecting 10K US patients and peak US sales of $250M

FDA Fast Track status,Orphan drug designation, US patent protection

BIV201

FDA

8BIV201 offers advantages in 40+ countries where Terlipressin is already approvedTargeting improved efficacy and safety compared to IV bolus dosing

IV bolus dosed terlipressin is an effective drug approved around the world for BEV and HRS

Avoids high risk IV bolus dosing; uses ~50% less drug per day

BIV201 is delivered via safer continuous infusion by ambulatory infusion pump

IV Bolus Terli.

RisksTraditional IV bolus dosing now associated with spikes in drug concentrations

BIV201

9Clinically de-risked development program

• BIV201 is continuous infusion (CI) terlipressin – a novel dosing method to improves safety compared to traditional IV bolus dosing

• 2016 Italian study in 78 patients with hepatorenal syndrome (HRS) demonstrated improved safety with CI vs. IV bolus dosing1

o CI group had >50% fewer serious adverse events (SAEs2)

o CI group response rate (76%) was higher than IV bolus (65%), but

not statistically significantly

• 2 independent overseas studies of CI terlipressin in refractory ascites patients provide reasons to believe:

o 11/11 patients responded to therapyo Reduction in ascites fluid and improved kidney function

1 Cavallin et al. 2016

2 SAEs included: Intestinal & peripheral ischemia, circulatory overload, angina, arrythmia,

arterial hypertension, persistent diarrhea.

The same therapy that is currently in use in Italy and Australia

10BIV201 revenue opportunity – US only

USPatients(000s)

Annual BIV201 Therapy Cost4

Total Addressable

Market (TAM)

Peak US Sales @ 50% Market

PenetrationRefractory/Intractable Ascites

19.81 $25.2 K $500 M $250 M

Bleeding Esophageal Varices (BEV)

6.63 $25.5 K $166 M $83 M

Catecholamine-Resistant Hypotension/Shock

125,0002 $1.2 K $150 M $75 M

Hepatorenal Syndrome (HRS)

16.83 $4 K $67 M $34 M

TOTAL: $442 M

Sources/Notes:1. D'Amico 2014; Gines 20042. La Jolla Pharmaceuticals market assessment, published 20153. US Patient Hospital Discharge Data, 20054. Ascites & BEV: Assumes three 21-day treatment regimens annually; CRH: Assumes 3 days

of therapy (Auchet, 2017) & HRS: Assumes 10 days of therapy; $400 per day WAC pricing assumption

11BIV201 international ascites treatment opportunity

Patients Diagnosed with

Cirrhosis

Ascites Patients(000s)

Est’d Refractory/ Intractable Ascites

(000s)

Japan 270,0001 541 10.8

Europe 800,0002 164 33

China 2 million3 500 100

Sources/Notes:1. Otsuka Pharmaceuticals market assessment, published 20132. BioVie assessment based on multiple sources 3. Minimum based on reported prevalence rates of cirrhosis in US/EU (China has highest

prevalence of HepB worldwide)

Potential to increase BIV201 revenues by >2X

12IP protection and FDA Fast Track status

Filed for patents in Japan, China & Europe

US Orphan Drug status for ascites to enable 7 years of market

exclusivity

FDA

FDA Fast Track status; will seek Breakthrough Therapy designation

FDA

US patent protection through 2036

USPTO

13BIV201 projected clinical timeline

14Experienced and effective management team

Jonathan Adams, President & Chief Operating Officer, DirectorIn 2007 founded the predecessor biotech company which evolved into BioVie. Over 28 years in pharma/biotech finance, commercialization, and marketing; key role at Searle Pharma in global commercialization of Celebrex.

Terren Peizer, Chief Executive Officer, Chairman of the BoardChairman of Acuitas Group Holdings, LLC, his personal holding company that owns of all of his portfolio company interests, including BioVie, NeurMedix, Inc. (a biotech company focused on inflammatory, neurological and neuro-degenerative diseases), and Catasys, Inc. Through Acuitas, Mr. Peizer also owns Crede Capital Group, LLC, an industry leader in investing in micro and small capitalization public equities, having invested over $1.2 billion directly into portfolio companies.

Penelope Markham, PhD, Chief Scientific Officer15 years in immunology, infectious disease, bacteriology and drug discovery research. She was a co-founder and Research Director for Influx, Inc.

15Experienced and effective clinical team

Patrick Yeramian, MDMedical Director

Denise Smith, MSVP, Mfg. Quality Assurance

Leslie Koehler, RACVP, Regulatory Affairs

Guadalupe Garcia-Tsao, MDYale School of Medicine, 2012 President of American Assoc. for the Study of Liver Diseases (AASLD)

Paolo Angeli, MDUniversity of Padova, Italy, Current Secretary of International Ascites Club

Clinical team Primary medical advisors

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Pioneering therapies for advanced liver diseaseNon-confidential investor presentation