BioVie Inc. (OTCQB: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
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1. 1
Pioneering therapies for patients
suffering from advanced liver cirrhosis
Corporate Presentation | June 2020
2. 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. BioVie cannot guarantee the effectiveness of its patents or Orphan Drug designations. A more
complete description of these risk factors is included in BioVie’s filings with the Securities and Exchange Commission.
In addition to the risks described above and in BioVie’s filings with the Securities and Exchange Commission, other
unknown or unpredictable factors also could affect BioVie’s results. No forward-looking statements can be guaranteed
and actual results may differ materially from such statements. 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.
3. 33
$600M 20,000
US patients
targeted for
BIV201 therapy
0/0
Number of FDA-
approved drugs to
specifically treat
ascites; Number of
direct competitors
Phase 2;
Ph3 in 2021
Mid-stage Phase 2
Orphan drug
candidate; FDA
Fast Track and will
seek Breakthrough
Therapy status
Orphan
Drug
Orphan Drug designations
for ascites and HRS with
potential 7 years market
exclusivity**; Patent-
pending liquid
formulations
BioVie Overview
Addressable US
ascites market size*;
Projected BIV201 US
peak sales of $400 M
with 67% penetration
Sources/Notes:
* D'Amico 2014; Gines 2004; Third party market assessment, published 2015; US Patient Hospital
Discharge Data, 2005; Assumes three 28-day treatment regimens annually.
** If first to market.
4. 4
Our initial target is ascites due to advanced
liver cirrhosis
• Cirrhosis is the 8th leading
cause of death in the US1
• Resulted in 49,500 US deaths in
20101
• Ascites is the most common
major complication2
• For refractory ascites the mean
one-year survival rate is only 50%3
Our first disease
target is ascites,
the accumulation
of 5+ liters of fluid
in the abdomen.
Fluid in the
peritoneal cavity
(ASCITES)
1Burden of Disease Collaborators 2013
2Ge and Runyon 20161US
3Bureau et al. 2017
5. 5
No effective medication options:
Primed for disruption
No drugs approved by FDA specifically for
treating ascites
Refractory ascites patients have frequent
paracentesis procedures:
• Withdrawal of ~5–10L of ascites fluid from
abdomen every week to 10 days with a large bore
needle*
• Provides short-term relief, but the kidneys will
eventually “burn out”
• Patients worsen with life-threatening
complications
• No remaining options except for TIPS** surgery
or liver transplant
* Wong 2012
** TIPS = transjugular intrahepatic portosystemic shunt to
channel blood flow around the liver
6. 6
Ascites patients incur $5 billion+ in annual
treatment costs
Source: HCUP Nationwide Readmissions Database 2016. Average length of stay and charges for patients requiring paracentesis.
7. 7
How our therapy is intended to
work:
• Vasoconstricts the central region,
forcing blood flow through the liver
• This restores effective blood volume
in the arteries, which
• Shuts down the RAAS signaling
pathway, so the kidneys no longer
retain excessive salt and water
• Thereby halting ascites fluid
production
Therapeutic goal: Halt the downward spiral
Adapted from: Wong 2012
8. 8
Exploring the potential for terlipressin
Terlipressin is approved in 40+ countries for
treating two related complications of liver cirrhosis:
HRS & BEV1
• Used for decades in hospitals dosed by IV bolus injection (1-2 mg
every 4-6 hours)
• Well understood mechanism of action2 with hundreds of
publications
• Not approved in the US or Japan
• Not yet approved to treat ascites in any country
BioVie advisor Dr. Paolo Angeli invented a new dosing
method as a continuous infusion in the outpatient setting
1. HRS = Hepatorenal syndrome; BEV = Bleeding esophageal varices
2. Ding 2013
9. 9
BIV201 clinical development program
BIV201 key clinical objectives are to:
• Deliver terlipressin safely via continuous infusion with a portable pump and
novel patent-pending liquid formulation in a pre-filled syringe
• Reduce ascites fluid accumulation
• Reduce ascites-related complications requiring hospitalization
• Enable at-home therapy
• Long-term bridge to liver transplant, or potentially avoid the need for
transplant*
Continuous infusion dosing: a new treatment paradigm
“Terlipressin given by continuous infusion is better tolerated than intravenous boluses
in the treatment of type 1 HRS. Moreover, it is effective at lower doses**”
BIV201 is an investigational therapy
BIV201
** HEPATOLOGY 2016;63:983-992.
* Based on Australian study results; will require US clinical trials to support this use.
10. 1010
Retrospective study results from P.Angeli, MD (Italy 2015)
Continuous infusion terlipressin
in 6 refractory ascites/HRS patients
Source: Adapted from BioVie US Patent application 16/379,446 Angeli et al.
No drug-related side effects were reported in this study.
Terlipressin is not available in the US
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Prospective study by Chapman et al. (Australia 2018)
Continuous infusion terlipressin
in 19 refractory ascites/HRS patients
Pre-therapy:
• 70% of patients required weekly large volume
paracentesis (LVP)
• 70% poor muscle strength
Results:
• Median duration of CI terlipressin treatment: 51
days
• 43% average reduction in frequency of paracentesis
• Significantly improved nutritional intake and muscle
strength
• No complications directly attributable to terlipressin
Decreased Need for Paracentesis
Change in frequency of paracentesis procedures
Source: JHEP 2019.
Terlipressin is not available in the US
12. 12
BIV201 Phase 2a study results in 6 refractory
ascites patients (completed April 2019)
Principal Investigator: Jasmohan Bajaj, MD at McGuire VA in Richmond, VA
Primary objectives to assess safety, tolerability and pharmacokinetics (PK)
Results1:
• Pharmacokinetics (PK) of continuous terlipressin infusion matched our predicted model2
• Serious complications observed over 2-month period during/after BIV201 therapy:
• Recurrence of hepatic encephalopathy (HE): 1 patient – possibly due to dehydration in conjunction with
strong response to terlipressin in conjunction with diuretics (protocol modified to avoid this)
• Leaking umbilical hernia: 1 patient (pre-existing) – not drug-related
• Other adverse events observed: bacteremia3, asymptomatic hyponatremia, abdominal
pain, headache, diarrhea, dizziness
• BIV201 therapy maintained for 28 days in 3 of 6 patients
1. Large-scale clinical trial(s) will be required to confirm results.
2. Source: BioVie poster presentation at AASLD 2019.
3. On day 28 possibly related to a chronic non-healing leg ulcer wound (one patient).
13. 13
BioVie Phase 2a trial results:
Timing of next paracenteses procedure
4 of 6 patients achieved
≥ 50% increase in days
until next ascites fluid
withdrawal
(paracentesis) after
starting BIV201 therapy
Source: BioVie poster presentation at
AASLD 2019.
BIV201 is an investigational therapy
14. 14
BioVie Phase 2a trial results:
Change in serum creatinine
4 of 6 patients
experienced a reduction
in serum creatinine
(clearance of SCr is an
indicator of kidney
function)
Source: BioVie poster presentation at
AASLD 2019.
BIV201 is an investigational therapy
15. 15
Advancing the BIV201 clinical program
• June 2019: Type C Guidance Meeting with FDA
• July: FDA meeting minutes received
• October: Submitted Phase 2b/3 Clinical Trial Protocol to FDA
• February 2020: Submitted FDA pre-meeting information package
• April 2020: FDA feedback received and trial design finalized
• Clinical study planned this summer:
A Phase 2 Randomized, Controlled, Dose-Titration, Open-Label Study Evaluating the Safety
and Efficacy of BIV201 in Addition to Standard of Care Compared to Standard of Care to
Reduce the Recurrence of Ascites and Complications in Patients with Refractory Ascites
Secondary to Decompensated Liver Cirrhosis (Clinicaltrials.gov NCT identifier 04112199)
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Phase 2 & 3 clinical trial plan
• US Phase 2 trial with 24 refractory ascites patients:
‒ 16 will receive BIV201 + standard of care (SOC); 8 receive SOC only (control group)
• Primary composite endpoint: Incidence of ascites-related complications, at least grade 2, over
180 days following randomization
• Secondary endpoint: Ascites fluid removed over 90 days
‒ Dosing: start at 3 mg/day for 28 days (titrate between 1-6 mg/day if needed)
‒ Enrollment: ~6 sites enrolling ~4 subjects on average
‒ Timeframe: 2 cycles BIV201 within 4 months and follow for 60 days; long-term follow-up
• Following completion of Phase 2, conduct a single pivotal Phase 3
randomized, controlled trial at ~20 US study sites
Source: clinicaltrials.gov (identifier: NCT04112199). The FDA provided additional guidance in April 2020;
certain risks associated with yet to be validated quality of life measures will be explored in Phase 2 trial.
17. 17 BIV201 is an investigational therapy
BIV201 projected clinical timeline
Phase 2a
Trial + PK Analysis
Completed
April 2019
Phase 2/3 Clinical Trials
YE/2018 YE/2020 YE/2021
Dose
1st Patient
Target
NDA*Filing
2022
* New Drug Application
YE/2019
BIV201 is an investigational therapy
18. 18
Novel BIV201 home care delivery system
BIV201 Premixed/
Prefilled Syringe
Needle-free
Connector
50 mL bag of saline for
insertion into pump
Portable pump
(carried in small satchel)
19. 19
Filed formulation PCT &
will apply for patent
coverage in US, Japan,
Europe, and China
US Orphan Drug
designations for both
ascites (Sept ‘16) and HRS
(Nov ‘18) to enable up to 7
years of market exclusivity
FDA Fast Track status;
will seek Breakthrough
Therapy designation
FDA
Creating global patent
estate to cover
proprietary liquid
terlipressin formulations
USPTO
IP protection and FDA Fast Track status
20. 20
Estimated US
Patients
(000s)
Total Addressable
Market (TAM)
Projected
Peak US Sales
Refractory Ascites 19.81 $600 M $ 400M*
Bleeding Esophageal Varices
(BEV)
6.63 $166 M $83 M
Catecholamine-Resistant
Hypotension/Shock
125,0002 $150 M $75 M
Hepatorenal Syndrome (HRS) 16.83 $67 M $34 M
TOTAL: $792 MSources/Notes:
* Planned US sales force: 30 reps/mgrs targeting 3,000 US liver disease specialists @$200K
full cost per person = $6M per year
1. D'Amico 2014; Gines 2004
2. Third party market assessment, published 2015
3. US Patient Hospital Discharge Data, 2016
Note: Ascites & BEV assumes three 28-day treatment regimens annually; CRH assumes 3 days of
therapy (Auchet, 2017); HRS Assumes 10 days of therapy
BIV201 revenue potential – US only
21. 21
Will Seek
Patent
Coverage
Patients
Diagnosed
with Cirrhosis
Estimated
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. Third party 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 Hepatitis B worldwide)
BIV201 international ascites treatment opportunity
Potential to increase BIV201 revenues by >2X (excluding China)
✓
✓
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Experienced and effective management team
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 Chairman of the Board of Directors and CEO
of Catasys since inception in 2004. Mr. Peizer is the Founder, Chairman, CEO and majority shareholder 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 his portfolio company
interests, including BioVie, NeurMedix and Catasys. Acuitas is an industry leader in investing in micro and small
capitalization public equities, having invested over $1.2 billion directly into portfolio companies. Previously he was
Chairman of Cray, Inc., the leading supercomputing company, and 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.
Jonathan Adams, President & Chief Operating Officer, Director
In 2007 founded the predecessor company to BioVie with over 29 years of biopharma industry experience including
finance, M&A and licensing deals, technology commercialization, global product launches, drug marketing and sales
force management. Mr. Adams was a member of Searle Pharma’s global launch team for Celebrex and worked on the
commercialization of follow-on COX-2 inhibitors. After Searle was acquired, he was a vice president/account supervisor
for healthcare advertising agencies and developed expertise covering a wide range of drugs and medical devices.
Subsequently he became a leader of Mission Pharmacal’s urology division. Mr. Adams earned a BS at Cornell University
and an MBA at the Tuck School at Dartmouth.
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Accomplished Board of Directors
Chairman of the Board: Terren Peizer Director: Jonathan Adams
Cuong Do
President, Samsung Global Strategy Group;
former Chief Strategy Officer at Merck; former
partner at McKinsey who led their healthcare
practice.
Michael Sherman
Former managing director at Barclays and
Lehman Brothers; significant experience in health
care finance; previously a securities attorney.
Richard J Berman
Former Chairman of National Investment Managers
with $12 billion pension administration assets;
director of Catasys, Inc., Advaxis, Inc., Cryoport Inc.
and Immuron Ltd. Previously started the M&A and
Leveraged Buyout Departments for Bankers Trust
Company.
Jim Lang
CEO of Eversana, and health services company.
Former CEO of healthcare analytics firm Decision
Resources Group; active investor and advisor to
several healthcare companies.
24. 24
Experienced and effective clinical & financial team
Penelope Markham, PhD, Chief Scientific Officer
Dr. Markham led the development of modified terlipressin compounds for LAT Pharma LLC, the predecessor company
to BioVie, for 7 years prior to its acquisition by BioVie. Previously, she spent 15 years in immunology, infectious
disease, bacteriology and drug discovery research. Dr. Markham was a co-founder and Research Director for Influx,
Inc. engaged in antibiotic drug discovery. She has been a member of NIH grant review panels and consulted in a
variety of therapeutic areas including Orphan drug development. Dr. Markham has more than 20 publications in peer-
reviewed journals and three patents.
Patrick Yeramian, MD, Chief Medical Officer
Dr. Yeramian brings over three decades of drug research and medical device experience to BioVie. He has served as a
medical director for multiple organizations including Searle Pharmaceuticals (now Pfizer) and TapImmune Inc. During
his career, he has helped companies to file more than 20 investigational new drug and device applications
(IND/CTX/CTAs), and won regulatory approvals for five new drugs and devices.
J. Wendy Kim, CPA, Chief Financial Officer
Over 25 years of experience in accounting and finance. As a CFO she managed corporate finance and operational
groups, closed M&A transactions and secured bank financings.
Denise Smith, MS, Vice President of Manufacturing
Managed the development laboratory for a large CMO, including analytical development and validation, and
established manufacturing processes for parenteral products (liquid, lyophilized, liposomes, emulsions) for new
chemical entities for the National Cancer Institute and other contract customers.
Leslie Koehler, RAC, MBA, Vice President of Regulatory Affairs
Former Director, Global Regulatory Affairs for Baxter Healthcare’s pharmaceuticals division. Serves as a regulatory
consultant for several pharmaceutical companies.
25. 25
World-leading medical advisory team
Paolo Angeli, MD
Head of the Unit of Hepatic Emergencies and Liver Transplantation at the University of Padova, Italy. He has
participated in more than 15 clinical trials (Phase II – IV) in the treatment of clinical complications of portal
hypertension and liver transplant. Currently he is Secretary of the International Ascites Club and, as a member
of EASL, has participated in drafting guidelines for the management of patients with cirrhosis and ascites. Dr.
Angeli has pioneered the use of continuous infusion terlipressin as a safer alternative to the traditional
approach of intermitted IV bolus dosing in the treatment of hepatorenal syndrome. He is a frequent speaker
on liver disease and has been widely published.
Lead medical advisor
26. 2628
Company highlights
• BIV201 is a novel therapeutic approach to a severe unmet medical need
• Mid-stage drug candidate in US development for ascites
- No drugs ever approved by FDA to treat ascites
- Similar therapy currently in practice in Australia*
• Clinical development plan:
- Commence Phase 2 clinical study this summer
- Commence pivotal Phase 3 trial in 2021
- Submit NDA for US marketing approval in 2022
• IP estate includes two Orphan drug designations and formulation patent application
• High cost of patient care creates strong economic rationale for drug therapy
• $400 million sales opportunity for ascites in US alone
• Additional revenue opportunities for related conditions and global expansion
* Source: ABC News Australia, March 5, 2018
27. 2727
Capitalization table
Capital structure as of June 1, 2020
Common shares outstanding
(Ticker: BIVI)
5,199,346
Warrants (WAEP: $4.52) 1,374,666
Options (WAEP: $10.50) 68,400
Fully-diluted shares 6,642,412