Professional Documents
Culture Documents
Flu Vaccine
Multi-Season
Multi-Strain
Flu Vaccine
CORPORATE PRESENTATION
JUNE 2018
2
All statements in this communication, other than those relating to historical facts, are "forward-looking statements" within the meaning of the United States
Private Litigation Reform Act of 1995. You can identify forward-looking statements by terms including ‘‘anticipates,’’ ‘‘believes,’’ ‘‘could,’’ ‘‘estimates,’’
‘‘expects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘plans,’’ ‘‘potential,’’ ‘‘predicts,’’ ‘‘projects,’’ ‘‘should,’’ ‘‘will,’’ ‘‘would,’’ and similar expressions intended to identify forward-
looking statements. These forward-looking statements relate to our business and financial performance and condition, as well as our plans, strategies,
objectives and expectations for our business, operations and financial performance and condition. However, these forward-looking statements are not
guarantees of future performance and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control,
uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results,
performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results to differ materially
from our expectations include, among others: the risk that drug development involves a lengthy and expensive process with uncertain outcome; BiondVax's
ability to successfully develop and commercialize its vaccine; the length, progress and results of any clinical trials; the introduction of competing products; the
impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals to
commercialize BiondVax's products; the difficulty in evaluating business prospects; the adequacy of available cash resource and the ability to raise capital
when needed; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; changes in the global
pharmaceutical industry; changes in customers’ budgeting priorities; European Medicines Agency and other regulatory authority approvals; natural disasters;
labor disputes; rising interest rates; general market, political or economic conditions in the countries in which we operate; pension and health insurance
liabilities; volatility or crises In the financial market; arbitration, litigation and regulatory proceedings; and war or acts of terror.
Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. You
should not unduly rely on any forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking
statements will be achieved or will occur. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the
Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2017 filed with the U.S. Securities and
Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov, and in the Company’s periodic filings with the SEC. Readers are urged to
carefully review and consider the various disclosures made in the Company’s SEC reports, which are designed to advise interested parties of the risks and
factors that may affect its business, financial condition, results of operations and prospects. These forward-looking statements speak only as of the date of
this presentation, and we assume no obligation to update or revise these forward-looking statements for any reason, whether as a result of new information,
future events or otherwise, except as required by law.
1. http://www.biondvax.com/2017/06/biondvaxs-ceo-provides-first-half-2017-general-corporate-update/
2. http://www.biondvax.com/2017/03/biondvax-approved-for-grant-from-israels-ministry-of-economy-and-industry-to-build-facility-for-commercial-scale-production-of-its-universal-flu-vaccine/
3. http://www.biondvax.com/2017/06/european-investment-bank-eib-supports-late-stage-development-and-production-of-biondvaxs-universal-flu-vaccine-candidate-under-horizon-2020-initiative/
4. http://www.biondvax.com/2017/07/biondvax-reports-positive-phase-2b-clinical-trial-results-for-its-universal-flu-vaccine/
5. http://www.biondvax.com/2017/09/biondvax-announces-closing-of-10-million-public-offering-of-american-depositary-shares-and-exercise-of-over-allotment-option/
6. http://www.biondvax.com/2017/12/biondvax-plans-phase-3-clinical-trial-following-receipt-of-scientific-advice-from-the-european-medicines-agency-ema/
Flu
A serious
challenge
for public
health
5
Flu cases:
Severe illness: Deaths:
up to 20%
3 – 5 million 650,0002
or 1.5 billion
❖ At-risk Seniors: 80% of deaths & most hospitalizations3
❖ High economic burden: Over $87B including $56B in elderly4
❖ USA: Up to 56,000 deaths and 710,000 hospitalizations5
PANDEMIC FLU
❖ New pandemic strain: When?… Where?... Which?
❖ Higher morbidity & mortality worldwide
2010-11 60%
Why current solutions fall short… 2011-12 47%
NIH: “During the period from 1989 to 1997 the vaccination rate for
elderly persons ≥65 years of age in the US increased from 30 to 67%.
Despite this increase in coverage, mortality and hospitalization rates
continued to increase rather than decline as would be expected...”
International Journal of Epidemiology5 (Vol. 35, Issue 2, P352-353)
5086–5096; 5 https://academic.oup.com/ije/article/35/2/352/694736;
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Mid 90’s 1st of two 1st of four FDA accepts EMA Scientific
Phase 1/2 (IL) Phase 2 (IL, EU) IND Advice accepts
BiondVax Phase 3 trial design
Operational
2 BVX-008 2018 USA Adults (18-49) 120 NIH: 1st participant enrolled April 2018
3 BVX-010 2018 E. European Adults (50+) 9,630 In preparation
*One • For
BVX-007 Allconducted
was : The Universal Fluwith
in collaboration Vaccine
the EU’s UNISEC consortium
12
0.25
** 0.25
M-001 twice Day 42
* * M-001 twice Day 42
0.2 0.2
0.15 * * 0.15
0.1 0.1
UNISEC (EU): statistically significant anti viral cytokines UNISEC (EU): 13 fold increase in responders expressing 2 cytokines (18-60 Y)
1000 1400 *
* P<0.05 “Multiple-Cytokine-
1200 1347
800 Producing Antiviral CD4
% over placebo
1Jacob Atsmon et al. Priming by a novel universal influenza vaccine (Multimeric-001)—A gateway for improving immune response in the
elderly population. Vaccine 32 (2014) 5816–5823
13
50
40
circulate in future years.” – Vaccine 2
30
20
70
10 In 2011 we *
0 administered M-001 60
% Seroprotection (HAI)
A/California/7/09 A/Perth/16/09 B/Brisbane/60/08
H1N1 pandemic swine flu to seniors 65+ 50
60
20
50 seroprotected from a
40 new epidemic strain 10
30
(A/Swiss) that didn’t 0
20
10 exist in 2011! TIV 2011/12 M-001 & TIV 2011/12
0
A/Brisbane/59/07 A/Brisbane/10/07 B/Brisbane/60/08 * P<0.05
1. Jacob Atsmon et al. Priming by a novel universal influenza vaccine (Multimeric-001)—A gateway for improving immune response in the
elderly population. Vaccine 32 (2014) 5816–5823
2. Lowell GH et al. Back to the future: Immunization with M-001 prior to trivalent influenza vaccine in 2011/12 enhanced protective immune
responses against 2014/15 epidemic strain. Vaccine (2017)
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• Population: 9,630 participants aged 50+, half 65+ years old, first cohort enrollment expected autumn 2018
• Primary Endpoints: Safety & clinical efficacy by reduction of illness rate
• Secondary Endpoints: Reduced severity of influenza illness; Lot-to-lot consistency of three M-001 batches
Type-specific (H1) synthetic • Broad H1 antibody Successful ferret challenge study (January
DNA antigens responses 2018)
• Voluntarily delisted from Tel Aviv Stock Exchange January 22, 2018.
(ADS-Shares 1:40 ratio)
BVXV
Balance Sheet Highlights (Q4 2017) BVXVW
• $21M cash on hand, no debt (~$48M invested to date)
• €20M EIB non-dilutive co-funding agreement1 signed June 2017
• Secondary offering Sept 2017, $10M gross proceeds
1 European Investment Bank (EIB) €20M support for M-001 Phase 3 trials and commercial production also includes:
• Zero-percent fixed interest loan for five years after each of the 3 drawdowns
• Variable remuneration based on royalties of net sales
• Milestone based drawdowns. Ultimate milestone includes regulatory authorization to launch Phase 3 trial
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(1) We assume 6.35% CAGR from $4B in 2015 http://www.cnbc.com/2015/10/19/the-16-billion-business-of-flu.html (2) Technavio: 27Jan2018, Source: http://bit.ly/2DJ6Mlv (3) http://www.reports-research.com/news/datamonitor-
vaccine-market-overview-2010.html [Accessed 20 Nov 2016] (4) http://www.who.int/immunization/sage/meetings/2013/november/SAGE_WG_H5vaccine_background_paper_16Oct2013_v4.pdf (5) https://www.gsk.com/media/4629/fy-
2017-results-announcement.pdf [At exchange rate 1.24] (6) https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/Q4-results-2017/ [At exchange rate 1.08] (7) http://annualreport.csl.com.au/year-in-
review/business-highlights.htm (8) https://www.astrazeneca.com/content/dam/az/PDF/2017/Full-Year/Full-Year%202017%20Results%20announcement%20.pdf
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MANAGEMENT
Ron Babecoff Tamar Ben-Yedidia Uri Ben-Or Shimon Hassin Joshua Phillipson
DMV, MEI PhD CPA, MBA PhD Hon. BSc
Founder,
CSO CFO COO BD
President & CEO
•Degree from University of Liège • Co-inventor of the universal • Degree from College of • Degree from University of • Hon. BSc. from University of
(ULG) flu vaccine Administration Maryland Biotechnology Toronto
•Master in Entrepreneurship & • Degree from Weizmann • Glycominds Ltd. (VP Finance) Institute • Accenture (Business
Innovation (ISEMI, Swinburne) Institute of Science • Menorah Capital Markets • Kadimastem (CEO) Management Consultant)
•Omrix Biopharmaceuticals Ltd • Biotechnology General Ltd. (Comptroller) • InSight Biopharmaceuticals • BioData Ltd. (Marketing
(Marketing Manager) (Head of Bioprocessing) Manager)
•Dexcel Pharma (Regional Export
Manager)
BOARD OF DIRECTORS
Prof. Avner Rotman, PhD Biodar (CEO), Rodar (Founder), Israel Biotech Organization (Chairman,
Chairman of the Board Steering committee)
Dr. George Lowell, MD ID Biomedical (CSO), Intellivax (Founder), Walter Reed General Hospital
Director (Consultant)
Ron Babecoff, DMV, MEI Omrix Pharmaceuticals Ltd (Marketing Manager), Dexcel Pharma
Founder, President and CEO Technologies Ltd. (Formerly Dexxon, Regional Export Manager))
Mr. Isaac Devash, MBA Credit Suisse First Boston (Investment Banking), Private equity and venture
Director capital funds (Founder)
Mrs. Michal Marom Brikman, CPA Linkury Technology International Group (CFO), Union Bank, Spectronix,
Director Biomedix incubator, ADO group, Arko holdings, Algomizer (Director)
Dr. Ruth Ben Yakar, PhD BioSight Ltd (CEO, Director), SHL Telemedicine (Director), Cellect
Director Biotechnology (Director)
Dr. Morris C. Laster, MD BioLineRx (CEO, Director), OurCrowd (Partner), Clil Medical (CEO), Vital
Director Spark (CEO), Kitov Pharmaceuticals (Co-founder, Director)
CAP TABLE
Exercise
Nasdaq: BVXV ADS ADS Expiration
31 Dec 2017 Outstanding
% price
Equivalent Date
NIS ($)
Ordinary ADS 6,535,490 75.18%
Warrants issued to
65,425 0.75% $ 6.25 May 11, 2020
underwriters
Fully Diluted
Shares 8,693,269 100.00%
Outstanding
Voluntarily delisted from Tel Aviv Stock Exchange January 22, 2018. (ADS-Shares 1:40 ratio)
Vaccine Compositions of Filed: Australia, Canada, China, Europe, Hong Kong, India, Israel,
Multimeric Multi-epitope Production & 4/3/2014
WO 2015/151103 Japan April 2035
Influenza Polypeptides formulation BiondVax
and their Production Under Examination: USA