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Pioneering therapies for advanced liver disease
Non-confidential investor presentation | December 2018
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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.
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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
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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
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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
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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
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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
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
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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
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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
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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
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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
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BIV201 projected clinical timeline
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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.
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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
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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
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Pioneering therapies for advanced liver disease
Non-confidential investor presentation