9th annual conference biotech showcase - neurovive · 9th annual conference biotech showcase...
TRANSCRIPT
9th Annual Conference
Biotech Showcase
January 10, 2017
CEO Erik Kinnman,
MD, PhD, MBA
Important information - Disclaimer
This presentation (the “Presentation”) has been prepared by NeuroVive Pharmaceutical AB (publ), 556595-6538 (“NeuroVive” or the “Company”).
The Presentation is governed by Swedish law. The courts of Sweden have exclusive jurisdiction to settle any dispute arising out of or in connection with this Presentation.
This Presentation does not constitute an offer of financial instruments to the public or an admission of such financial instruments to trading on a regulated market requiring an approved prospectus under the Swedish Financial Instruments Trading Act (1991:980) and, accordingly, this Presentation does not constitute a prospectus for these purposes and have not been, and will not be, approved or registered by the Swedish Financial Supervisory Authority (Sw: Finansinspektionen) under the Swedish Financial Instruments Trading Act.
Forward-looking statements
The Presentation contains certain forward-looking statements that reflect NeuroVive’s current views or expectations with respect to future events and financial and operational development. The words “intend”, “estimate”, “expect”, “may”, “plan”, “anticipate” or similar expressions regarding indications or predictions of future developments or trends and which are not based on historical facts constitute forward-looking information. Although NeuroVive believes that these statements are based on reasonable assumptions and expectations, NeuroVive cannot give any assurances that such statements will materialize. Forward-looking statements are in its nature involved with both known and unknown risks and uncertainties, since they are depending on future events and circumstances. Forward-looking statements do not constitute any representations and warranties of future development and the outcome could differ materially from the information set out in the forward-looking statements.
The forward-looking statements included in this Presentation apply only to the date of this Presentation. NeuroVive undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events orsimilar circumstances other than as required by applicable law.
NeuroVive in brief
• Swedish specialist pharma company
• Focused on mitochondrial medicine
• One project in patient studies
• Strong and agile network pharma organization
• Listed on Nasdaq Stockholm (NVP.ST)
• Market cap 19 MUSD
• Average trading volume 320,000 (Jan 2017)
• OTCQX (NEVPF:US) June 2, 2016
Mitochondria
Food
Oxygen Energy
• Essential for body energy and functioningof vital organs
• Resists, repairs damage and controls cell death
• A non-functioning or damaged mitochondrionleads to cell death and organ damage
NeuroVive develops compounds that protect and enhance mitochondrial function
NeuroVive Project Pipeline
Traumatic brain injury (TBI)
• Traumatic brain injury occurs after external trauma
• Deteriorates for several days
• Leads to significant neurological disabilities and high burden of disease
• >3 million patients annually in US and EU
• 15 % medium to severe damage
• 60 BUSD in direct medical and indirect costs in the US 20001
1 www.cdc.gov/traumaticbraininjury/pdf/BlueBook_factsheet-a.pdf
TBI NeuroSTAT® Clinical phase II study
• Orphan drug designation EU and US
• Open phase II safety pharmacokinetic study
• 2 doses, 5 day treatment
• 16/20 patients have been recruited
• Complementary experimental efficacy study at University of Pennsylvania ongoing
• Readout expected H1 2017
• NeuroSTAT possible market approval year
• 2024E*: US & EU5
• 2026E*: JP & CH
• Peak sales 2 BUSD (2030E*)
* Monocl Strategy Services 2015
Mitochondrial disorders
• Rare and heritable mutations- 12.5 per 100,000
• Deteriorates continuously with periods of energy crisis
• Several organs and tissues risk being affected
Eyes
Drooping eyelids (ptosis),
inability to move the eyes
sideways (external
ophthalmoplegia), blindness
(retinitis pigmentosa)
Muscles
Muscle weakness, exercise
intolerance, seizures
Digestive system
Regurgitation, vomiting,
chronic diarrhea, intestinal
obstruction
Pancreas
Diabetes
Liver
Liver failure is rare except in
infants experienceing loss of
mitochondrial DNA
Kidney
Fanconi syndrome (the
loss of key metabolites in
the urine)
Heart
Cardiomyopathy (heart failure,
conduction block)
Nervous system
Seizures, tremors, mental
retardation, deafness, dementia,
stroke before the age of 40,
balance disorders, effects on the
peripheral nervous system
Mitochondrial disorders - Systemic effects
NVP015 for mitochondrial disorders
• Energy regulating substance
• Candidate drug selection H2 2017
• Overcomes complex I deficiencies
• Limits the complications of an energy crisis
• Pharmaceutical strategy published in Nature Communications August 20161
• NVP015 possible market approval
• 2024E2: US & EU5
• 2026E2: JP & CH
• Peak sales 375 MUSD (2031E2)
1 Ehinger et al. Nature Communications, 7:12317, August, 20162 Monocl Strategy Services 2015
Mitochondria
Cell
Blood
NV556 organ protection
Energy
NV566PT-pore block
• NV556 in preclinical development
• Possible clinical indications:
• Liver disease
• Myopathies
• Acute kidney injury
NASH – non-alcoholic steatohepatitis
Fatty liver
Fibrosis
Cirrhosis
• Part of nonalcoholic fatty liver disease (NAFLD)
• 30% of the US population
• Strong association NASH and diabetes/obesity
• 3-5 % of the US population (15M people)
• Buildup of fat and inflammation in the liver
• May lead to liver cirrhosis and hepatocellular carcinoma
• No registered drugs on the market1
• 15 BUSD global market estimated by 20252
1 Vernon G. et al. Aliment Pharmacol Ther. 2011;34(3):274-852 Cassidy S. & Syed B.A. Nature Reviews Drug Discovery 15, 745–746 (2016)
Two out-licensing projects
NV556
• Orally available
• Extensive preclinical development documentation
• Good safety profile
• Prevents fibrosis development in a well-validated experimental model of NASH
• Confirmatory long term studies ongoing
NVP022
• New compound class directed towards mitochondrial metabolic signaling pathways
• Compounds under evaluation
• Complementary to NV556 NASH treatment
NASH – Disease development
Metabolicpathways
Inflammation
Fibrosis
Cirrhosis
Disease severity
Time
NV556
NVP022NASH
NAFLD
Mitochondrial myopathy
• Symptoms include muscle weakness, exercise intolerance and fatigue
• Caused by malfunctioning mitochondria
• Kearns-Sayre syndrome, myoclonus epilepsy with ragged-red fibers, and MELAS
• Myopathy most common symptom in mitochondrial disease 12.5/100,000
• No approved drugs
• NV556 will be studied in experimental models of mitochondrial myopathy in collaboration with Prof. Håkan Westerblad at the Karolinska Institutet
Mitochondrial myopathy
NeuroVive business model
Discovery Pre-clinicalPhase I
(first in human)
Phase IIa
(proof of principle)
Phase IIb and
Phase III (confirmatory)
Marketing & Sales
Common specialist/open
care productsOut-license
Idea Product
NeuroVive development of orphan/niche products
In-license Orphan/niche products
Long term company goals
• Profitable growth in 5-10 years
• Bring orphan/niche projects to the market and build commercial organization
• Out-license large indication specialist and open care projects
• Build on scientific mitochondrial medicine excellence
• Develop drugs in a strong and agile network pharma organization
Agile and lean clinical development
• Investigator initiated trials
• Enable access to ”soft money”
• Smart clinical trial design
• E.g. adaptive designs, biomarkers, enriched trials
• Orphan drug designation, breakthrough therapy
• Faster to the market and limited documentation need
• Orphan drug status
• Higher price: average 110,000 USD up to 400,000 USD/patient/year in the US
• Market exclusivity 7 years in US (10 years in EU)
NeuroVive AsiaTaipei, TWN
Research
Philippe GalleyCA, U.S.
PENN UniversityPennsylvania, U.S.
Isomerase Cambridge, UK
Lund UniversityLund, SE
A1M PharmaLund, SE
Suzhou HuasaiZhangjiagang, CN
Shanghai Chempartner, Shanghai, CN NeuroVive Asia
Taiipei, TWN
Cambridge Major Laboratories Europe, Holland
Innovative networking model
SDSStockholm, SE
Fresenius KabiGraz-Puntigam, AT
Sanofi KoreaSeoul, KR
Sihuan PharmaceuticalBeijing, CN
Skåne University Hospital Lund, SE
RigshospitaletKöpenhamn, DK
NeuroVive AsiaTaipei, TWN
Development
Maas Biolab, LLCAlbuquerque, NM
Innovative networking model
Financial position
30 September 2016 MUSD
Intangible assets 7.4
Liquid assets 11.2
Short-term debts 1.1
Burn rate until 201609* 8
Burn rate 201512* 10
* Cash flow from operating and investment activities
NeuroVive summary
• Strong portfolio with one ongoing clinical study and several research projects
• World leading in mitochondrial medicine
• Business model that enables near term revenue and value creation mid- to long term
Erik Kinnman,
CEO
Expertise: Research
and development,
strategy, IR, business
development.
MD, PhD, MBA
Catharina
Johansson, CFO
Expertise: Growth
companies within
medical technology,
multinational operations
and partnership
activities
Eskil Elmér,
CSO, Founder
Expertise: Preclinical
and clinical research.
MD, PhD
Magnus Hansson,
CMO
Expertise: Preclinical
and clinical research
and development. MD,
PhD
Cecilia Hofvander,
IR & Comm Director
Expertise: More than 15
years experience from
investor relations within
small/mid cap biotech
NeuroVive's Management Team
NeuroVive's Board of Directors
Greg Batcheller, Executive ChairmanExecutive Chairman since 2008 and board member since
2000. Batcheller is a commercial lawyer, business developer
and project manager. He has many years’ experience in
working with pharmaceuticals, biotechnology and medical
equipment.
Arne FerstadBoard member since 2010. Ferstad is co-owner of Ankor
Consultants, based in London. He has held the position of
chairman for Baxter Healthcare in the Nordic and Benelux
countries, as well as being European president of Baxter
healthcare’s Renal Division. Prior to that, Arne held several
executive leadership positions in Asia, the U.S. and Europe
for Baxter.
Boel FlodgrenBoard member since 2013. Boel is a professor in commercial
law and former principal at Lund University. She has an
extensive experience in research and teaching within the
field of business law at Swedish as well as foreign universities
such as Stanford and Harvard, U.S.
Anna Malm BernstenBoard member since 2013. Bernsten has an extensive
international experience in strategic marketing, product
launching and business development within pharmaceutical
and biotech companies such as Medivir, GE Healthcare and
Pharmacia&Upjohn.
Marcus KeepBoard member since 2000. Neuro surgeon at PinnacleHealth
Neurological Surgery in Harrisburg, Pennsylvania, U.S. Keep is
also CEO and Executive Chairman of Maas Biolab, LLC, one of
the largest shareholders in NeuroVive. He was formerly
assistant professor of neurosurgery at the University of
Hawaii and the University of New Mexico. Keep was a visiting
researcher at Lund University between 1994 - 1996.
David Laskow-PooleyBoard member since 2016. Laskow-Pooley is a member of the
board of TapImmune Inc, USA, OBN Ltd, England and
Pharmafor Ltd, England. Laskow-Pooley earned his degree in
BSc Pharmacy (1st), Pharmaceutical/ Chemical engineering
specialty and QP. from Sunderland School of Pharmacy,
England.
Helena LevanderBoard member since 2012. Levander is the founder of nordic
Investor Services. She has extensive experience in financial
markets and asset management through working with SEB,
Nordea and Odin Funds.
Major shareholders 30 September 2016
Owner Voting rights and capital
(%)
Avanza Pension Försäkrings AB 12.42
EuroClear Bank S.A/N.V(Registers holdings for Maas Biolab, LLC and Marcus
Keep and others Based in the U.S.
8.98
Baulos Capital 8.84
Nordnet Pensionförsäkring AB 2.96
Danske Bank International S.A. 2.23
Handelsbanken Liv 2.09
Redmayne Nominees Ltd UK Clients 1.43
Eskil Elmér 0.87
Greg Batcheller 0.82
Skandia försäkring 0.76
Remaining ̴7,200 owners 58.6
In total 100
www.neurovive.com