pioneering therapies for advanced liver disease · terlipressin is already approved targeting...
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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
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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
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
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