Nordea Markets Stockholm, February 10, 2012 Svein Mathisen, CEO Sten Westerberg, VP Investor Relations - A clinical portfolio on top of a drug ...
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- A clinical portfolio on top of a drug discovery platform -
Nordea Markets
Stockholm, February 10, 2012
Svein Mathisen, CEO
Sten Westerberg, VP Investor Relations
Forward-looking statements
This presentation includes forward-looking statements based on
the beliefs and expectations of the Company. These statements
are based on the Company’s current plans, estimates and
projections, as well as of expectations of external conditions and
events. All such forward-looking statements involve inherent risks
and uncertainties. Hence actual results could differ materially from
those discussed in, or implied by, these statements.
2
Highlights in BioInvent Q4 report
BI-204
Phase IIa GLACIER increased to 144 patients (120)
Expansion allows for more conclusive read-out
First data expected in Q3
TB-402
First data on phase IIb study in Q2
Partner process to be intensified on back of positive data
TB-403
Phase Ib/II GBM study ongoing
Phase Ib study in HCC discontinued
BI-505
First-in-man phase I data possible in Q2
Servier
Collaboration initiated in Oncology
3
Key figures
Key Financial Figures
SEK mln € mln*
Annual accounts, Jan-Dec Annual accounts, Jan-Dec
2011 2010 2011 2010
Net revenues 124.6 82.9 13.8 8.7
Sales and administrative costs -32.6 -32.2 -3.6 -3.4
Research and development costs -163.7 -178.5 -18.1 -18.7
Operating profit/loss -71.7 -127.8 -7.9 -13.4
Profit/loss from financial investments 4.6 -0.6 0.5 -0.1
Profit/loss for the period -67.1 -128.4 -7.4 -13.5
Cash and cash equivalents 174 106 19.4 11.8
4
* Average exchange rates are used for P&L data; for balance sheet data exchange rates are used as of 31 Dec
Value inflection points in 2012
Commercial
Project Indication Phase I Phase II
Partner
Deep vein thrombosis Results
TB-402* Q2
TBD
(total hip replacement)
Results
BI-505 Multiple Myeloma Q2
TBD
Secondary prevention of CV Results
BI-204
events (acute coronary syndrome) Q3
North America
* Program co-developed with ThromboGenics
5
Maximizing value by bringing mAbs to clinical PoC
Clinical Proof of Concept
(PoC)
Approval/
Preclinical Phase I Phase II Phase III
Marketing
Key strengths
Focus on unique medical concepts Late stage clinical trials and
In depth knowledge of disease market launch conducted by /
BioInvent
biology in oncology and inflammation with partners
pipeline
Collaborative model with industry Intend to integrate forward
and academia
Partner access to library
Technology Lead discovery funded by partner
provider Milestones and royalties on all
programs
6Proven track record in partnering
Partners Deal structure Financials
BI-204 North-American License Approximately €50 mln received so far
& Co-Development Up to €300 mln in future milestone payments
TB-403 Global License & Royalty on product sales
Co-Promotion Value from retained rights
Sharing costs and revenues
TB-402 Co-Development
Inflammation
Co-Development
Potentially more than 30 programs
Discovery of Product Up to €13 mln in future milestone payments per
Candidates on behalf of program
Partners Royalty on product sales
Cost of programs fully funded by partner
7BI-204: Addressing a new target in cardiovascular
disease
8BI-204
BI-204: Addresses the culprit in atherosclerosis
Human antibody developed for secondary prevention of cardiac events in acute
Description coronary syndrome patients
BI-204 binds a specific oxidized peptide linked to the bad cholesterol – LDL
Mode of action Modulate macrophage activity and reduce vascular inflammation
Market opportunity Address unmet need in attractive acute secondary prevention markets of ~3mln patients
in Europe and N-America
First phase II data expected Q3 2012
Status Validation by Genentech partnership
Genentech deal in 2007 worth $190m plus royalties (160m remaining)
Partnership Has the commercialization rights in North America
BioInvent has retained rights in Rest of World
9BI-204
Highest unmet need early after event
Prove-IT (2004) PLATO (2009)
STEMI, NSTEMI, ACS STEMI, NSTEMI, ACS
MACE=death, MI, USA requiring hosp, Revasc, Stroke MACE=death, MI, Stroke
10BI-204
Mode of action hypothesis
BI-204 is hypothesized
to form an immune
complex with oxLDL,
which can bind Fcg-
receptors on the pro-
inflammatory
macrophage and
thereby induce a
phenotype switch in the
macrophage to a less
pro-inflammatory
phenotype. BI-204 is
also known to scavenge
oxLDL in plaque.
Source: BioInvent CMD, Nov-11
11BI-204
Decrease of plaque burden and plaque macrophages
Y
Antibody induced regression Antibody induced decrease of
of plaque burden plaque macrophage content
BI-204 BI-204
Anti-oxLDL Ab Anti-oxLDL Ab
Schiopu et al, JACC 2007 12BI-204
Phase IIa design
144 patients with stable atherosclerotic BI-204 single dose (n=48)
cardiovascular disease
Subset of patients per arm with type 2
diabetes BI-204 multiple doses (n=48)
All patients on standard-of-care
including statin
Placebo (n=48)
Screening Treatment Follow-up
(1 month) (~3 months) (~3 months)
Age 35-80 years Primary outcome measure: ∆Level of inflammation after
Screening: Level of inflammation treatment measured by FDG-PET
measured by FDG-PET Secondary parameters:
Enrolled at ~20 clinical sites Biomarkers: inflammatory & metabolic
Safety
13BI-204
Clinical development plan
• Phase IIa: Topline results expected in Q3 2012
• Phase IIb: Additional dose finding to establish dose for Phase III
• Phase III: Event based (MACE) primary efficacy endpoint in ACS patients
14TB-402 - A first-in-class, long-acting, anti-
coagulant targeting Factor VIII
15TB-402
TB-402: Novel anti-coagulant therapy
Human monoclonal antibody developed for single dose prevention
Deep vein thrombosis in surgery and medical patients
Description Future opportunities
Secondary prevention of venous thromboembolism
Stroke prevention in atrial fibrillation
Mode of action TB-402 enables partial, well controlled inhibition of Factor VIII
Safe, effective, single dose therapy
No dose adjustments in hepatic and renal insufficiency
Flat dosing
Strategic positioning
One shot compared to daily dosing for LMWH and oral drugs
Single dose corresponding to 2 – 5 weeks duration
Antidote (factor VIII concentration, NovoSeven)
Phase ll a study in knee surgery shows significantly better anti-thrombotic
effect than enoxaparin
Status
Phase llb in hip surgery ongoing
To be reported in Q2 2012
16TB-402
TB-402: Focus on prevention in patients at risk
Prophylaxis (“preventive treatment”) aims at avoiding serious
Growing focus on complications in high risk surgical and medical patients
prevention
Surgical patients at risk: Today only 60% receives adequate prophylaxis
Medical patients at risk: Today only 40% receives adequate prophylaxis
Increasing market as extended prophylaxis is implemented
Significant patient
population
Applied to major markets
Country # Surgical patients # Medical patients
(mln) (mln)
US 5.1 6.1
UK 1.9 1.9
Germany 2.8 2.9
France 1.9 1.8
Source: Endorse study: study was conducted in 358 hospitals in 32 countries (Lancet 2008)
17TB-402
Results of phase IIa study in knee surgery
Design Results
Design % of patients with P < 0.05%
a VTE
Thromboprophylaxis following knee surgery
Open label, dose escalation study
50%
Three dose levels of TB-402:
Single injection (0.3, 0.6 or 1.2 mg/kg) 40%
Active control (Enoxaparin): >10 days 30%
316 patients across 30 centers in Europe 20% 39,7%
10% 21,7%
Primary outcome measurements 0%
Composite of the occurrence of asymptomatic TB-402* Enoxaparin
DVT
detected by bilateral venography and TB-402 was superior to Lovenox (enoxaparin),
symptomatic VTE (i.e. DVT or fatal or the current standard, for the prevention of
non-fatal PE) asymptomatic DVT
Occurrence of total bleeding
defined as major and/or clinically TB-402 had similar safety profile to enoxaparin
relevant non-major bleeding events,
from randomisation until end of study
* Pooled data, ARR 17.4% (95% CI 5.2-29.6)
18TB-402
Phase IIb study in hip surgery
To evaluate the efficacy and safety of a single administration of TB-402 for the prevention of
VTE in patients undergoing hip replacement surgery
2-4 hrs: 25 mg TB-402 iv (n=210)
Total Hip Replacement 2-4 hrs: 50 mg TB-402 mg iv (n=210)
6-10 hrs: 10 mg rivaroxaban QD for 35 days (n=210)
19BI-505 – Targeted treatment in Multiple Myeloma
20BI-505
BI-505 & Blockbuster Market in Oncology
Fully human antibody developed as a treatment for Multiple myeloma (cancer of
Description antibody producing cells)
Forces cancer cells into “suicide mode” (induces programmed cell death)
Mode of action Targets ICAM-1 (Inter-Cellular Adhesion Molecule 1), a protein overexpressed in
several tumours
Incidence 40.000 in the seven major markets
Market opportunity Blockbuster market: Current drugs (Revlimid, Velcade) have annual sales of $ 4.3
billion (2010)
Address patients who do not respond to (40%) or relapse from present treatment
Strategic positioning Potentially improved side effect profile
Phase I ongoing
Status High efficacy and potent anti-tumour activity pre-clinically
Orphan Drug Designation in Europe and US
100% rights exclusively held by BioInvent
Partnerships
21BI-505
BI-505: Translating solid science to the clinic
ICAM-1 is highly and selectively expressed in Multiple Myeloma
ICAM-1
expression in
Multiple
Myeloma
Primary: To reach the Study Maximal Dose (SMD) or the Maximum Tolerated Dose (MTD) and assess
the safety and tolerability in patients with multiple myeloma
Secondary: To determine the following in patients with advanced multiple myeloma
Phase I Define the Optimal Biological Dose (OBD) by assessing
objectives Pharmacodynamics, pharmacokinetics and immunogenicity
Tumour response rate by the IMWG (International Myeloma Working Group guidelines)
criteria
35-40 patients at 2 US and 4 European sites
Source: Schmidmaier et al. Int J Biol Markers 2006; 21; 218-22 22TB-403 – Innovative Cancer Treatment
23TB-403
TB-403: Innovative cancer treatment
Description Humanized monoclonal antibody developed to treat solid tumours
Aims “starve” tumour by blocking blood vessel growth (angiogenesis) through
inhibition of PlGF*
Mode of action
Inhibits tumour angiogenesis without affecting normal tissue
Less likely to develop resistance
Market opportunity Blockbuster market: Avastin (anti-VEGF) > $ 6 billion in annual revenues 2009
Combination with chemotherapy (and Avastin) in major markets
Strategic positioning
Treatment of patients who progress during Avastin therapy
Status Phase Ib/II in Glioblastoma multiform (GBM) ongoing
Partnership Roche deal in 2008 worth EUR 500m (431m remaining) plus royalties
* PIGF is overexpressed in several tumours, VEGF homologue
24Conclusion of Investment case
Solid clinical pipeline at
4 product candidates addressing large unmet clinical need
the brink of value
inflection points Two phase II and one phase I read-outs in 2012
Validation through Technology platform validated by industry leaders
strong partnerships Numerous partnerships including Roche, Genentech, Bayer,
Human Genome Sciences and Daiichi
Focus on therapeutic Fastest growing segment in the pharmaceutical industry
antibodies In-house drug discovery capabilities to feed portfolio
25Appendix 26
Key figures
Shareholder base as of December 31
Shareholders # of shares Ownership Shareholders # of shares Ownership
(%) (%)
JP Morgan Bank nominee 4,813,807 7.2% SEB Life Assurance 1,405,400 2.1%
DnB NOR Fonder 4,488,311 6.7% Tangent Fund 1,370,718 2.0%
B&E Participation AB* 3,913,000 5.8% Mikael Lönn 1,300,000 1.9%
Staffan Rasjö 2,981,621 4.4% Sixth AP fund 1,268,718 1.9%
Avanza Pension Insurance 2,940,314 4.4% Carl Borrebaeck* 1,142,908 1.7%
Nordnet Pension Insurance 2,630,401 3.9% Stena Group 1,120,000 1.7%
Länsförsäkringar Fonder 1,780,408 2.6% Svein Mathisen* 1,050,000 1.6%
Friends Provident Intern. 1,751,740 2.6% Other shareholders 31,632,357 47.5%
Third AP fund 1,615,790 2.4% Total 67,205,257 100.0%
Shareholding as per December 31 2011.
* Insiders by being represented in management and/or board of directors
27Scientific overview
The Power of n-CoDeR® - Variability beyond nature
Conventional library
construction – the No of antibody variants = (nIg genes)2
dimeric format
No of antibody variants = (nIg genes)6
n-CoDeR library
construction – the
hexameric format
n-CoDeR library construction
• All element proof-read by the
human immune system
• Low immunogenicity
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