Forward-Looking Statements
This document contains forward-looking statements made pursuant to the safe harbor provisionsof the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties andassumptions that could cause BioVie’s actual results and experience to differ materially fromanticipated results and expectations expressed in these forward looking statements. BioVie has insome 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 differmaterially from those expressed in forward-looking statements are BioVie’s need for, and theavailability of, substantial capital in the future to fund its operations and research anddevelopment. Other risks are that BioVie’s compounds may not successfully complete pre-clinicalor clinical testing, or be granted regulatory approval to be sold and marketed in the United Statesor elsewhere. A more complete description of these risk factors is included in BioVie’s filings withthe 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 anyrevisions to any such forward-looking statements that may be made to reflect events orcircumstances after the date of that these slides are posted to BioVie’s website or to reflect theoccurrence of unanticipated events, except as required by applicable law or regulation.
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BioVie (OTCQB: BIVI) Company Highlights
• Lead drug candidate BIV201 has Orphan Drug designation and US patent protection
• Commencing Phase 2a clinical trial in June 2017
• Initial target is ascites due to advanced liver cirrhosis– ~20,000 US patients and ~$500M US sales potential
• Developing a global franchise with $1 billion+ sales potential targeting multiple liver cirrhosis complications (HRS, BEV, other)
• Active agent in BIV201, terlipressin, is available in ~40 countries (not in US)
• “Proof-of-concept” as continuous infusion in ascites– 2 independent studies overseas with 11/11 responders, no serious AES
• Proven management, directors, medical advisors
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Stock Information (as of 5/18/17)
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Symbol: ….............................................BIVI
Stock Price: ……………...........................$0.23
52-Week Range:…....................$0.12 - $0.45
Average Daily Volume:....................... 9,910
Shares Outstanding:…...........................92 M
Inside Ownership:…..............................46%
Market Cap:….....................................$21 M
Website:........................www.biovieinc.com
MANAGEMENT
• Jonathan Adams, CEO, 28 years in
pharma/biotech finance, commercialization,
and marketing; key role at Searle Pharma in
global commercialization of Celebrex.
• Julie Anderson, COO, former marketing director
for Durata Therapeutics and Searle, where she
led Celebrex global marketing.
• Amrit Shahzad, President, BioPharma business
development across therapeutic areas;
leadership roles at Roche, Amgen, Ikaria.
MEDICAL ADVISORS
• Guadalupe Garcia-Tsao, MD, Yale School of
Medicine, 2012 President of AASLD
• Paolo Angeli, MD, University of Padova, Italy,
Current Secretary of International Ascites Club
• Roberto Groszmann, MD, Professor Emeritus
Yale School of Medicine
Management Team and Advisors
BOARD OF DIRECTORS
• J. Adams, A. Shahzad, J. Anderson
• Cuong Do, Executive VP, Samsung Global
Strategy; former Chief Strategy Officer at
Merck; former partner at McKinsey, where he
helped build the healthcare practice.
• Jim Lang, former CEO of healthcare analytics
firm Decision Resources Group; former CEO of
Strategic Decisions Group; active investor and
advisor to several healthcare companies.
• Hari Kumar, former CEO of Amira
Pharmaceuticals and Adheron Therapeutics,
which he sold very successfully
CLINICAL TEAM
• Penny Markham, PhD: Chief Scientist
• Patrick Yeramian, MD: Medical Director
• Stacy Suberg, PhD: Regulatory Lead
• Denise Smith, MS: CMC/Manufacturing Lead
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Initial Target: Ascites Due to Liver Cirrhosis
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• Ascites is the accumulation of excessive fluid in the abdomen, usually caused by liver cirrhosis
• ~40% mortality rate within 2 years of ascites diagnosis1
• Per year direct treatment costs of cirrhosis exceed $4B, with ~326,000 hospitalizations annually
• Current recommended therapy:– Salt-restricted diet and diuretics (off-label)
– Paracentesis (withdrawal of fluid by large needle)
• The FDA has never approved any drugs specifically for treating ascites
1 D’Amico 2014.
BIV201 Pipeline
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ClinicalProgram Pre-IND Phase 2 Phase 3
Care Setting
Estimated USPatient Pop.
Refractory/Intractable/ Advanced ascites
Ambulatory
Bleeding esophagealvarices (BEV)*
In hospital
Type 2 HRS* Ambulatory
Catecholamine-resistanthypotension
In hospital
Prevention of BEV Ambulatory
20,000
6,000
5,000
125,000
20,000
* HRS-1 and BEV hospital use approved in Europe; BEV approved in Asia.
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ClinicalProgram Pre-IND Phase 2 Phase 3
Care Setting
Target NDA Filing
Refractory/Intractable/Advanced ascites
Ambulatory
Bleeding esophagealvarices (BEV)
In hospital
Type 2 HRS Ambulatory
Catecholamine-resistanthypotension
In hospital
Prevention of BEV Ambulatory
2020
2020
2020
2021
2022
BIV201 Opportunities with P2 Trial Success
Mortality Rates and Peak Revenue Estimates
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ClinicalProgram Estimated Mortality
Orphan Drug Potential?
Peak Revenue Estimates (US only)
Refractory/intractable/ advanced ascites
• 50% survival over 6-12 months• Newly-diagnosed ascites: 40%
mortality rate within 2 years
BIV201 hasOrphan
designation$500 M
Bleeding esophagealvarices (BEV)
• 15 – 25% mortality at 6 weeks after bleeding episode Yes $200 M
Type 2 HRS
• HRS-2 – median survival 6-12 months
• HRS-1 (hospitalized) – median survival of 1.7 to 4 weeks
Yes $200 M
Catecholamine-resistanthypotension
• 28-day mortality exceeds 50%
Yes $500 M
Prevention of BEV Yes $200 M
BIV201 Potential Future Applications Supported by Investigative Studies
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Therapeutic Application Support
Refractory ascites, Ascites Gow 2016, Angeli 2016, Fimiani 2011
Bleeding esophageal varices (BEV) Approved ex-US (~40 countries)
Type 2 HRS/Acute kidney injury (AKI) Jindal 2016, In use in Italy
Septic shock/hypovolemic shockVasodilatory shock
Morelli 2009Serpa Neto 2012
Hypotension: Orthostatic, anesthesia-induced Rittig 1991, Lange, 2008
Prevention of BEV Conceptual support
Type 1 HRS Approved ex-US
Recurrent Type 1 HRS Piano 2011
Paracentesis-induced circulatory dysfunction Singh 2006, Moreau 2002
Improved liver regeneration after partial hepatectomy Fahrner 2014
Hypertensive gastropathy bleeding Bruha 2002
Perioperative use during living donor liver transplant Ibrahim 2015, Fayed 2013
Trauma-related blood loss (burn excision) Burns 2004
Sepsis Lange 2007 (sheep study)
BIV201 Clinical Development Plan
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• BIV201 is designed to achieve continuous low concentrations of the active vasoconstrictive agent (terlipressin) in the bloodstream
• Clinical development program in refractory/intractable ascites:− Submitted IND application in November 2016
− FDA clearance to conduct P2a received March 2017
– Projected clinical development timeframes (subject to change):
o June 2017: Commence P2a clinical trial (6 patients open-label)
o Year 2: Conduct P2b study with control arm (possibility of qualifying as a P3 study)
o Year 3: Conduct pivotal P3 study
o Year 4: NDA filing
BIV201 IP Strategy
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• 3-tier intellectual property strategy:1. Orphan Drug exclusivity
o Orphan designation for BIV201 for ascites granted
o 7 years of US market exclusivity in ascites
o Applying for additional Orphan opportunities
2. Patent protection
o US patent notification of allowance received in April 2017
o Filed for refractory ascites in Japan and China; PCT in Europe
3. NCE protection and follow-on indications
o Targeting first approval of terlipressin NCE in US, which would provide 5 years’ protection against generics
o Add 6 months for new indications (BEV, HRS, hyponatremia, etc.)
MOA and Rationale for Ascites
Liver Cirrhosis
Hepatic Resistance
Portal Hypertension
Splanchnic Blood Pooling
Ascites
Low Arterial Blood Pressure
Activation of RAAS etc.
Excess Retention of Salt + Water
BIV
201
Expected to decrease
splanchnic vasodilation
and portal hypertension
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Clinical Design Based on Overseas Experience
• European study conducted by Dr. Paolo Angeli using continuous IV infusion in HRS patients (Cavallin, M: Hepatology, Dec. 2015)– 78 HRS patients randomized to IV infusion or bolus dosing
– Infusion dose started at 2 mg/day (mean daily dose of 2.23 mg/day vs. 3.5 mg/day for bolus dosing)
– Side-effects were reduced by ~50% with continuous IV infusion, with similar efficacy
• Gow study in refractory ascites patients (published July 2016)– All 5 patients responded to therapy with no serious adverse events
– 48% reduction in ascites fluid drained
– Significant improvements in renal function (sodium excretion, etc.)
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Similar Results for Angeli2 and Gow3 Studies
2Angeli patent application published Jan 2017 on WTO website (WO 2017/004317 A1)3Gow et al. Letter to Ed. AJ Gastroenterology Jul 2016.
U.S. Disease Incidence – Hospitalizations
• ~138K patients were hospitalized in the US for liver cirrhosis complications in 2010
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Upcoming Milestones
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• Planning to commence mid-stage (Phase 2a) clinical trial shortly of BIV201
• Phase 2a trial will take ~8 months to complete
• Applying for US Orphan Drug designations for other complications of liver cirrhosis
• Seeking patent protection in Japan and China; leverage European PCT “placeholder” at later date
• Seeking $4 - $5 million to fund the Phase 2 clinical trial program
Stock Information (as of 5/18/17)
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Symbol: ….............................................BIVI
Stock Price: ……………...........................$0.23
52-Week Range:…....................$0.12 - $0.45
Average Daily Volume:....................... 9,910
Shares Outstanding:…...........................92 M
Inside Ownership:…..............................46%
Market Cap:….....................................$21 M
Website:........................www.biovieinc.com