Disclaimer This presentation includes forward-looking statements regarding Bionor Pharma ASA, including projections and expectations, which involve risk and uncertainty. Such statements are
included without any guarantees to their future realization. Although Bionor Pharma ASA believes that the expectations regarding the Company reflected in such forward-looking statements are
based on reasonable assumptions, no assurance can be given that such projections will be fulfilled. Any such forward-looking statement must be considered along with knowledge that actual
events or results may vary materially from such predictions due to, among other things, political, economic, financial or legal changes in the markets in which Bionor Pharma ASA does business,
and competitive developments or risks inherent to the Company’s business plans. Many of these factors are beyond Bionor Pharma ASA’s ability to control or predict. Given these uncertainties,
readers are cautioned not to place undue reliance on any forward-looking statements. The Company does not intend, and does not assume any obligation, to update the forward-looking
statements included in this presentation as of any date subsequent to the date hereof.
A brief introduction to Bionor Pharma
NORDIC HEALTH CARE CONFERENCE, DNB MARKETS, 6 DECEMBER 2012
STEEN KRØYER, CEO
This is Bionor Pharma
3
Norwegian led
Proprietary platform
Attractive portfolio
Experienced management
World class advisors
Substantial investment
bionorpharma.com
Bionor Pharma Pipeline
An attractive product portfolio with long term patents
4
bionorpharma.com
Advisory Boards
Providing independent clinical and scientific advice
Biographies available on bionorpharma.com
Clinical Advisory Board
Scientific Advisory Board
Richard Pollard, USA
Leiv K. Sydnes, Norway
John E. Newbold, USA
Kristian Prydz, Norway
Knut Helkås Dahl**, Norway
Jürgen Rockstroh, Germany
Brian G. Gazzard, UK
Barry S. Peters*, UK
Guiseppe Pantaleo, Switzerland
Robert R. Redfield, USA
Dag Kvale, Norway
Angus «Gus» Dalgleish, UK
Professors, except: *MBBS, DFFP, MD, FRCP ** MSc, PhD, ERT, DABT
bionorpharma.com
bionorpharma.com
The history of AIDS
1968–2012
US Department of
Health: “We will have
a preventive AIDS
vaccine within two
years!”
Norwegian sailor,
Arvid Noe dies of
AIDS
1968
First US case of
AIDS
1976
1981–
1983
First report on
homosexual lifestyle
association
Hiv virus identified by
Francoise BarreSinousse, Pasteur
Institute
7
First AIDS
medicine
“cocktail”
approved
by FDA
(Antiretroviral
therapy, ART)
bionorpharma.com
1984
<
1986
Over 1 mill.
HIV infected
in the US
1992
The history of AIDS
1968–2012
15% of new infected tied to
blood donation
1997
New, improved
ART, with less side
effects
2000
NIAID (National Institute
for Allergy and Infectious
Diseases) spends $680
million to combine 2
preventive vaccines, with
marginal success
2009–
2011
2007
First known HIV
infected patient cured
(“Berlin Patient”)
2012
Eradication strategy
highlighted
• Approx.35 mill HIV infected
globally (1400 in Norway)
• Most common treatments today:
ART – one pill every day / HAART
(Highly Active ART) – combination
of several ART, to reduce resistance.
8
bionorpharma.com
The conventional treatment
And why we need new HIV treatments
Conventional HIV medicine (ART) effectively reduces virus,
and prevents it from multiplying in the bloodstream.
However:
Does not destroy virus producing cells – puts the cells into resting state only
Risk of serious, irreversible side effects, especially by long term use
Resistance
Not lasting effects - must be taken daily
Limited access - only 1 in 4 who needs ART has access to it
Does not cure HIV
9
bionorpharma.com
Platform Technology
Our platform technology
With roots back to diagnostic product development in 1985
1
3
The Challenge with viruses
Viruses escape from attacks by the immune
system by continuously changing its surface
structures (proteins)
Prevents, treats, and potentially cures some
of the world’s most deadly viruses
4
2
The vaccine redirects the immune system to
detect and target specific structures of the
virus that remain unchanged and vulnerable
11
Bionor Pharma´s focus
Vaccines for unmet medical needs, such as
HIV, universal influenza and Hepatitis C
How our vaccines work
This results in removal of virus producing
cells and reduction of virus level
Capabilities
5
Further potential
The technology provides a platform with potential for
5
developing new vaccine products for a large number
of viruses diseases
bionorpharma.com
Vacc-4x
A new generation of HIV treatment
Peptides, chosen from unchanging parts of the virus
Synthesized and modified to increase killing of HIV
infected cells
Produced by Bachem AG, Switzerland
Harvard researchers have recently documented that a
HIV vaccine should target the unchanging structures
of the virus (Dahirel et. Al., PNAS 2011)
Vacc-4x targets unchanging structures of the virus
Kills and removes virus producing cells – immune
system educated
No adverse side effects
No development of resistance
12
bionorpharma.com
Immune activation
is always required for AIDS to develop
Why do some people not get AIDS ?
Why do chimpanzees not get AIDS ?
Answer: The only difference is that there is no evidence
of immune activation (which is chronic and associated
with inflammation, and has auto immune features).
How does HIV cause Immune activation ?
Can we switch it off ?
Answer: This is the unique approach included by Bionor
Pharma
13
bionorpharma.com
Chronic immune activation is
like background noise on the
radio which prevents the signal
from being heard!
Angus "Gus" Dalgliesh,
Member of Scientific Advisory Board
14
bionorpharma.com
Vacc-C5
Improves the immune response
Targets unchanging structures of the virus
Induces antibodies against HIV, which reduce
hyperactivation of the immune system
Prevent spread of the virus
Improves the immune response
Vaccine induced antibodies in animals
First human trial approved, and started Q4 2012
Vacc-HIV: Combination of Vacc-C5 (inducing
antibodies) and Vacc-4x (inducing killer T-cells), can
thereby stimulate both parts of the immune system
15
bionorpharma.com
What does this mean?
Antibodies to the C5 region of HIV prevent immune activation, and
thereby prevent disease progression
If we induce these antibodies (which is the aim of Vacc-C5), they could
neutralize the disease
Stopping activation will stop virus production
16
bionorpharma.com
Other indications
Other indications in the product pipeline
Vacc-HCV
Vacc-FLU
Cancer indications
Hepatitis C
Universal influenza vaccine: all
pandemic influenza viruses
Human papillomavirus (HPV,
throat / cervical cancer)
Market size: ~ 500 million
patients
Cytomegalovirus (CMV, e.g.
brain tumor)
Preclinical development
(including toxicology), planned
finalized during 2013
Patent applications filed June
2012
Vacc-HCV developed to treat
and cure
Market size: ~ 170 million
patients
Patent application filed June
2012
Potential partner to be identified
Patent application filed June
2012
Potential partner to be identified
17
bionorpharma.com
Clinical studies
PERFORMED AND ONGOING
Vacc-4x: Completed clinical studies
Until mid 2012
1 - Open Study Phase I/II, NO: 11 patients, 100% immune response. Safe vaccine without
side effects (1999-2000)
2 a - Open Study Phase II, NO: 40 patients (CD4 count at inclusion >300 cells/μl), ARTfree period on average 31 months (2003-2004). Sustained CD4 counts, and transient
reduction in viral load
2 b - Open Study Phase II Reboost , NO (7 years after 2a): 26 patients from 2a , with 2/3
of patients showing active memory response. Immune response enhanced after reboost
with Vacc-4x (2010)
3 - Placebo-Controlled Study Phase II, USA and Europe (18 centers): 135 patients (CD4
count at inclusion >400 cells/μl). Statistically significant reduction of HIV viral load in active
group compared to placebo. Supportive immunological data (2008-2010 )
4 - Open Study Phase I/II, Nasal Vaccination, NO: 24 patients, droplets of Vacc-4x in the
nose, resulting in positive immune response. Potentially easier treatment and access for
HIV patients globally (2011-2012)
19
bionorpharma.com
HIV viral load
20
bionorpharma.com
Reduction of HIV viral load following
vaccination with Vacc-4x
21
bionorpharma.com
Three new studies at sixteen sites
1
1
3
Vacc-4x + Revlimid
Reboost with Vacc-4x
Vacc-C5 phase I/II
2
4
4
1
Vacc-4x reboost
Reboost with Vacc-4x in patients from the phase II study
Approval Q4 2012 USA +
Patient group Participants from the
4 European countries,11 clinics, ca. 40
previous phase II study with Vacc-4x
patients
The primary endpoints Changes in
First patient enrolling Dec. 2012
viral load compared to the previous
Design Two immunizations of Vacc-4x
while on ART, then up to 16 weeks of
vaccine
treatment interruption. Total study period 37
Aim of the study To determine
weeks.
whether a lower viral load level (“set
Funded Globvac (Norwegian Research
Council) and Bionor Pharma ASA
23
study and immune responses to the
point”) can be achieved by re-boosting
previously vaccinated HIV infected
patients
bionorpharma.com
Vacc-4x + Revlimid®
Vacc-4x in combination with Celgene`s immune modulator Revlimid®
Approved Germany, August 2012,
4 clinics, approx. 36 patients (~12+24)
Patient group Well controlled viral load
on conventional HIV medicine (ART), but
failing to regain normal immune function
(15-20% of all HIV patients)
First dose group initiated treatment
October 2012
Design First dosing-study with ~12 patients,
determining “maximum tolerated” dose of
Revlimid®. Then 24 patients for 26 weeks.
Funded Jointly with Celgene, owner of the
blockbuster cancer drug and immune
modulator Revlimid®
24
Primary endpoints Changes in the
amount of CD4 T-cells and immune
responses to the vaccine
Aim of the study Determining whether
the combination of Vacc-4x and Revlimid
can result in improved response to Vacc4x in HIV infected patients with poor
immune recovery (low CD4 T-cells despite
well controlled viral load on ART)
bionorpharma.com
Vacc-C5
Clinical phase I/II study
Approved Oslo University Hospital,
Patient group Well controlled on
May 2012, 36 patients
conventional HIV medicine
First patient treated November 2012
Primary endpoint Evaluation of the
Design “First time in man” open study,
vaccine’s safety
three different dose levels of Vacc-C5,
Secondary endpoint Antibody
each with two different adjuvants
responses to the vaccine.
(supporting agents). Twenty six weeks
study period for each patient.
Funded Bionor Pharma ASA
Aim of the study To determine
whether antibodies to two specific ,
conserved areas of the HIV virus (C5
and gp41) are induced in HIV patients
25
bionorpharma.com
Business
Development
Two Critical Steps
27
STEP
STEP
1
2
Documentation
process
Partnering
process
bionorpharma.com
STEP
Information Gathering & Preparation
1
Market & Commercial Research (Navigant, BCG,
McKinsey, KOL’s + Community Dr, etc. Market
entry/ramp up, pricing, commercialization options)
IP Position (Patents, Processes, Regulatory
exclusivity)
Clinical/Regulatory FDA Clarity (Cost, Timelines,
Inflection Points)
News Flow (Clinical Data, Patent Announcements,
Other Application)
Financial Analysis (Value, rNPV’s, MC Simulations,
DCF’s, POS’s, Key Assumptions)
28
bionorpharma.com
DELIVERABLES
MATERIALS
TPP’s (For Key Assets)
Non-Confidential Teaser
Full Briefing Book
Complete Data Room
STEP
Partnering Process
2
29
Diligence (Access to Briefing Book, Data room,
Management Q&A)
Partnering Solutions (Research Agreements,
License, M&A, which assets)
Indications of Interest & High Level Deal Terms
Key Meetings (Bio USA, JP Morgan, Regional
Conferences, Others)
bionorpharma.com
OUTCOME
ACTIVITIES
Identification of likely partners (Vaccine Specific
BD, Venture Sponsors w/in Big Pharma, others)
2-3 Potential partners
Auction process
Execute Deal
Upcoming events
Financial summary
Secured funding until mid 2014
OSE: BIONOR
Market Cap NOK 660 mill. / US$ 115 million
Number of Shares: 198 million
Private Placement was successfully closed 14 June 2012, with gross
proceeds of NOK 57.6 million. This placement together with previous
cash secures the funding of planned scientific and business related
activities until mid 2014
Cash as of Q3 2012: NOK 126.7 mill. / US$ 22.2 million
Annual burn-rate: NOK 60-70 mill. / US$ 10-12 million
31
bionorpharma.com
Summary
Ongoing Clinical Studies and Business Development Process
Proven effect of technology platform and
products
Comprehensive clinical and preclinical
program ongoing
Partnering process next 12-18 months
Exciting news flow during 2013
Visit
bionorpharma.com
for the latest
information
32
bionorpharma.com
Thank you for your attention.
33
bionorpharma.com