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

Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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Page 1: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

1

Pioneering therapies for advanced liver disease

Non-confidential investor presentation | December 2018

Page 2: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

2

Forward-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.

Page 3: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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BioVie (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

Page 4: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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$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 for

ascites and HRS

Page 5: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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Ascites: 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

Page 6: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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A 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 ascites

Therapeutic 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

Page 7: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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BIV201 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

Page 8: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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.

Risks

Traditional IV bolus dosing now

associated with spikes in drug

concentrations

BIV201

Page 9: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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Clinically 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 therapy

o 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

Page 10: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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BIV201 revenue opportunity – US only

US

Patients

(000s)

Annual

BIV201

Therapy Cost4

Total

Addressable

Market (TAM)

Peak US Sales

@ 50% Market

Penetration

Refractory 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

* US Orphan Drug designations granted for ascites and HRS (a deadly condition following

advanced ascites)

Sources/Notes:

1. D'Amico 2014; Gines 2004

2. La Jolla Pharmaceuticals market assessment, published 2015

3. US Patient Hospital Discharge Data, 2005

4. 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

Page 11: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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BIV201 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 2013

2. 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

Page 12: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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IP protection and FDA Fast Track status

Filed for patents in Japan,

China & Europe

US Orphan Drug designations for

both ascites and HRS to enable 7

years of market exclusivity

FDA

FDA Fast Track status; will seek

Breakthrough Therapy designation

FDA

US patent protection

through 2036

USPTO

Page 13: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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BIV201 projected clinical timeline

Page 14: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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Experienced and effective management team

Jonathan Adams, President & Chief Operating Officer, Director

In 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 Board

Mr. Peizer is an entrepreneur, investor, and financier with a particular interest in healthcare, having founded

and successfully commercialized several healthcare companies. Mr. Peizer is the founder of Catasys, Inc., a

leader in behavioral and mental health management services. He has served as the Company’s Chairman

of the Board of Directors and CEO since the Company’s inception in 2004. Mr. Peizer is the Founder,

Chairman and CEO of NeurMedix, Inc., a biotechnology company with a focus on inflammatory,

neurological and neuro-degenerative diseases. He is also the Chairman of Acuitas Group Holdings, LLC, his

personal holding company that owns all of his portfolio company interests, including BioVie, NeurMedix

and Catasys. 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. Mr. Peizer has a background in venture capital, investing, mergers and acquisitions,

corporate finance, and previously held senior executive positions with the investment banking firms

Goldman Sachs, First Boston, and Drexel Burnham Lambert. He received his B.S.E. in finance from The

Wharton School of Finance and Commerce.

Penelope Markham, PhD, Chief Scientific Officer

15 years in immunology, infectious disease, bacteriology and drug discovery research. She was a co-

founder and Research Director for Influx, Inc.

Page 15: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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Accomplished Board of directors

Chairman of the Board: Terren Peizer Director: Jonathan Adams

Cuong Do

President, Samsung Global Strategy; former

Chief Strategy Officer at Merck; former

partner at McKinsey in their healthcare

practice

Hari Kumar

Former CEO of Adheron Therapeutics and

CBO of Amira Pharmaceuticals; he sold

both companies very successfully

Michael Sherman

Former managing director at Barclays and Lehman

Brothers; significant experience in health care

finance; previously a securities attorney

Mina Sooch

Former CEO of Gemphire Therapeutics and former

CEO of ProNAi; both went public on NASDAQ

raising $100M+; venture capitalist

Jim Lang

Former CEO of healthcare analytics firm Decision

Resources Group; active investor and advisor to

several healthcare companies

Page 16: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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Experienced and effective clinical team

Patrick Yeramian, MD

Chief Medical Officer

Denise Smith, MS

VP, Mfg. & Quality Assurance

Leslie Koehler, RAC

VP, Regulatory Affairs

Guadalupe Garcia-Tsao, MD

Yale School of Medicine, 2012 President

of American Assoc. for the Study of Liver

Diseases (AASLD)

Paolo Angeli, MD

University of Padova, Italy, Current

Secretary of International Ascites Club

Clinical team Primary medical advisors

Page 17: Pioneering therapies for advanced liver disease · Non-confidential investor presentation | December 2018 Forward-looking statements 2 This document contains forward-looking statements

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Pioneering therapies for advanced liver disease

Non-confidential investor presentation