NOVOZYMES BIOPHARMA - Euroland
Transcript of NOVOZYMES BIOPHARMA - Euroland
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NOVOZYMES BIOPHARMA - PRODUCTS, TECHNOLOGIES AND MARKETS
Svend Licht, Senior Director, Novozymes Biopharma
JPM Healthcare, January 16th, 2014
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SAFE HARBOR STATEMENT
This presentation and its related comments contain forward-looking statements, including financial expectations. Forward-looking statements are by their very nature associated with risks and uncertainties that may cause actual results to differ materially from expectations. The uncertainties may include unexpected developments in the international currency exchange and securities markets, market-driven price decreases for Novozymes’ products, and the introduction of competing products in Novozymes’ core areas.
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NOVOZYMES – THE WORLD LEADER IN BIOINNOVATION
Household Care
Food & Beverages
Bioenergy Agriculture
& Feed Technical &
Pharma
Who are we?
*A+B shares July, 2013
Founded 1925
Listed 2000
Ticker NZYM B
Exchange Copenhagen
Market Cap (MDKK)* ~ 64,000
Long-term targets: > 10% organic sales growth from 2015 > 24% EBIT margin > 22% ROIC
Global: +6,000 employees, 700 products in 140 countries
R&D intensive: ~7,000 patents, 13-14% of sales spent on R&D
Profitable: ~2 Bn USD in sales and 24% EBIT margin in 2012
Majority owner Novo A/S controls 25.5% of the capital and 70% of the votes
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Bioenergy
• Corn ethanol • Cellulosic biofuels
• Leveraging competencies across segments accelerates pace of innovation, reduces competition and creates high barriers to entry
UNIQUELY DIVERSIFIED GROUP CREATES SYNERGIES AND NEW OPPORTUNITIES
Household Care
• Laundry & Dishwasher detergents
• Cleaning products
Food & Beverages
• Baking • Starch to syrups • Brewing & Alcohol • Healthy concepts
Agriculture & Feed
• Animal feed • BioAgriculture
Technical & Pharma
• Textile & Leather • Pulp & Paper • Wastewater • Pharma ingredients
4
16% 35% 28% 15% 6%
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Bioenergy
• Corn ethanol • Cellulosic biofuels
• Leveraging competencies across segments accelerates pace of innovation, reduces competition and creates high barriers to entry
UNIQUELY DIVERSIFIED GROUP CREATES SYNERGIES AND NEW OPPORTUNITIES
Household Care
• Laundry & Dishwasher detergents
• Cleaning products
Food & Beverages
• Baking • Starch to syrups • Brewing & Alcohol • Healthy concepts
Agriculture & Feed
• Animal feed • BioAgriculture
Technical & Pharma
• Textile & Leather • Pulp & Paper • Wastewater • Pharma ingredients
5
16% 35% 28% 15% 6%
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• Enzymes account for ~90% of turnover
• Sales FY 2012 of DKK 11,234 billion (USD ~ 2 billion)
• Strong profitability, 24.4% in EBIT margin FY 2012
• ROIC of 19.9% FY 2012
DIVERSIFICATION IN REVENUE STREAMS UNDER- PINS THE COMPANY’S STRONG FINANCIAL POSITION
2012 Sales by geography
2012 Sales by industry
Europe,
Middle
East and
Africa
37%
North
America
33%
Asia
Pacific
20%
Latin
America
10%
6
8%/8%
1%/(6)%
12%/5%
13%/13%
DKK growth/LCY growth
3.973
3.186
1.748
1.617
720
Household
Care
Food &
Beverages
Bioenergy
Agriculture &
Feed
Technical &
Pharma
35%
28%
16%
15%
6%
% of sales:
-12%/-17%
DKK growth/LCY
growth
DKKm
18%/14%
-2%/-9%
5%/1%
13%/11%
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9M 2013 SUMMARY
FY sales outlook adjusted for currency developments, EBIT margin increased
• Underlying sales performance in line with expectations and full year outlook narrowed
• Negative impact on sales in DKK from broad basket of currencies
• Expectation to EBIT margin increased due to productivity improvements, product mix and favorable cost development
9M performance in line with expectations
• 6% organic sales growth after 9M (7% in Q3) driven by all industries, spearheaded by Household Care
• Significant headwind from currencies
• EBIT margin up by 0.4 percentage point 0%
2%
4%
6%
8%
Q1 Q2 Q3 Q4
Accumulated organic sales growth and guidance, 2012 & 2013
2013
2012
Key financials Realized 9M 2013
Outlook October 25
Sales growth, DKK +5% 3-5%
Sales growth, LCY +7% 6-8%
Sales growth, org. +6% 5-7%
EBIT growth +6% 4-5%
EBIT margin 25.0% 24-25%
Net profit growth 8% 7-8%
Net investments excl. acq., DKKm
558 ~900
Free cash flow bef. acq., DKKm
1,235 1,600-1,700
ROIC incl. goodwill 19.8% 19-20%
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NOVOZYMES’ PRODUCTS & TECHNOLOGIES SUPPORT THE PHARMA COMPANIES IN THEIR DEVELOPMENT
Hyaluronic Acid
Bacillus-derived
hyaluronic acid
offering superior
safety, consistency
and performance
offers cost savings and
minimized risk
• Used as an ingredient
in medical devices and
pharmaceutical
products
Half-life Extension (HLE) Technology
• Next generation
albumin-based
technology to create
longer-lasting drugs
through albumin fusion
or chemical
conjugation
• Improved dosing
regimes for increased
patient compliance
Recombinant Albumin USP-NF*
• High quality and animal-
free recombinant
albumins developed to
provide customers with a
safe and consistent,
regulatory compliant
product
• Used as an ingredient to
stabilise drug and
vaccine products and in
medical devices
Enzymes for Biocatalysis
• Comprehensive
biocatalysis enzyme
portfolios including
lipases, proteases,
esterases, oxido-
reductases and
amylolytic enzymes
• Improved yields,
simplified processes
and fewer byproducts
in API manufacturing
*Meets National Formulary (NF) standards as published by United States Pharmacopeia (USP).
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STRONG MACRO TRENDS EXPECTED TO DRIVE NEED FOR IMPROVED DRUG DEVELOPMENT AND TREATMENTS
More wealthy populations:
End result: • Growing demand for biologics • Patent expiries driving new potential • Overall Healthcare Cost pressure • Regulatory framework is still very new
Aging populations:
Pressure to innovate and reduce cost:
• Diabetes
• Cancer
• Obesity
• …
• Osteoarthritis
• Cataract
• Dermal fillers
• …
• Need for well
defined ingredients
• Need for extended
dosing
• Need for liquid
stable formulations
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NOVOZYMES FOCUS ON SUPPORTING DRUG DEVELOPMENT
• Originator drugs
• Biosimilars ”generic” versions of
originator drug
=> Same treatment at lower cost
• Biobetters improved version of
the originator drug – e.g. with
improved serum half-life profile
=> Better treatment at lower
overall healthcare cost
• Biosuperiors new versions of the
originator/biobetter with e.g. other
modes of action.
=> Better treatment due to better
API action.
Novozymes provide solutions to Stabilize drugs
Improve formulation
Improve dosing regime
Increase patient compliance
Reduce manufacturing cost
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NOVOZYMES’ PRODUCTS & TECHNOLOGIES
Hyaluronic Acid
Hyasis
Half-life Extension (HLE) Technology
Albufuse Flex
Recombumin Flex
Recombinant Albumin USP-NF*
Recombumin Prime
Recombumin Alpha
AlbIX
Enzymes for Biocatalysis
*Meets National Formulary (NF) standards as published by United States Pharmacopeia (USP).
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HYALURONIC ACID - HYASIS
Novozymes Hyasis® is the next generation of high-quality hyaluronic acid offering superior safety, consistency and performance. Achievements: • Established as a strategic supplier for
several multinational players as well as smaller companies promoting novel Hyaluronic acid technologies
Key advantages: No animal-derived raw materials (Bacillus-
derived) No production of endotoxins or exotoxins No organic solvents Targeted molecular weight High batch-to-batch consistency in
production Fewer manufacturing deviations 5 x faster dissolving time Superior heat stability for more efficient
sterilization process Hyasis® Link – versatile and proven
crosslinking technology
With Novozymes Hyasis you get: • New standard for purity and cGMP level • Significant cost savings in production
• Minimized business risk with a reliable
supplier
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RECOMBINANT ALBUMIN - RECOMBUMIN
Novozymes Recombumin® products are ideal products for a range of applications including the manufacture of medical devices, drug delivery and drug stabilisation Key advantages: Excellent stabiliser for peptides, proteins
and vaccines
Can allow development of liquid presentations for patient convenience and compliance
Assured sourcing from a global leader in industrial biotechnology means robust supply chain
High purity, cGMP, animal-free materials designed for use in biomanufacturing
No need for warnings on final drug labels regarding risk of disease transmission
With Novozymes rAlbumins you get: • Quicker route to market with established
regulatory package
• Reduced risk with animal free sourcing
• Reduced quality associated costs
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Tunable half-life extension possibilities
Daily to weekly to monthly dosing regimes
Patent lifetime until at least 2030
1. Only HLE technology based on a natural and non-immunogenic plasma protein
2. Flexible implementation options - expression host, licensing models, and linkage routes (conjugation or fusion)
3. Proven to be safe with low regulatory risk, low potential immunogenicity
4. Strong proven heritage and track record
Key technological advantages:
Some partners for first generation Albufuse® Benefits of Novozymes’ HLE technology:
Novozymes’ HLE platform: Recombumin® Flex and Albufuse® Flex
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SHORT HALF-LIFE REDUCES THERAPEUTIC EFFECT
Improved pharmacokinetics to reduce dose/side effects
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Albumin has a naturally long plasma half-life:
• Human albumin – T1/2~19 days
• Size - retained by kidney/glomerulus
• FcRn (neonatal Fc receptor) recycling: pH-dependent recycling “rescues” albumin from degradation and prolongs half-life
ALBUMIN IS THE IDEAL VEHICLE FOR HALF LIFE EXTENSIONIS – DUE TO RESCUED FROM DEGRADATION BY THE FcRn RECEPTOR
1
10
100
1000
10000
100000
1000000
0 100 200 300 400
Mean
± S
EM
seru
m c
on
c.
(n
g/
mL)
Time (hr)
Albumin +FcRn engagement
Albumin -FcRn engagement 60%
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INCREASED RECEPTOR AFFINITY INCREASES (>2X) ALBUMIN HALF-LIFE IN A RANGE OF MODELS
• Albumin variants show similar trends across species with increased and decreased FcRn binding relating directly to decreased and increased half-life
• More than 2X increase in half life with albumin variants compared to native albumin
• Pharmacokinetics of albumins evaluated in a number of in vivo models • WT Mouse • Transgenic mouse* • Non human primate
NT – Not tested
*Transgenic mouse – human FcRn in mouse albumin background
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In silico studies
EpiMatrix Protein score
-29.9 to -32.0
In vitro Class II HLA binding and ex vivo T-cell assays
No significant HLA binding
2nd generation albumin variants
NO SIGNIFICANT IMMUNOGENICITY PREDICTED FROM SCREENING OF NOVOZYMES ALBUMIN VARIANTS
- 80 -
- 70 -
- 60 -
- 50 -
- 40 -
- 30 -
- 20 -
- 10 -
- 00 -
- - 10 -
- - 20 -
- - 30 -
- - 40 -
- - 50 -
- - 60 -
- - 70 -
- - 80 -
Thrombopoietin
Erythropoietin
IgA
Fibrinogen-Gamma
Albumin
IgG FC Region
GMCSF
Follitropin - Beta
Fibrinogen-Alpha
Beta-2-Microglobulin
Interferon-Beta
GHRH
Tetanus Toxin
Influenza-HA
EpiMatrix Scores
“Considering our global and regional analysis as a whole, we find the risk that these proteins will create or contribute to anti-therapeutic immune response to be minimal”
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NEXT GENERATION ALBUMINS OFFERING NEW OPPORTUNITIES IN DRUG DELIVERY
Optimise the pharmacokinetics and efficacy of your protein or peptide for: Control of dosing intervals Reduced dose Decreased toxicity
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A NUMBER OF ALBUMIN FUSION CANDIDATES ARE IN CLINICAL DEVELOPMENT
Company Deal Drug Target Pre-clin PI PII PIII MAA stage
GSK/ HGS Fusion + expression
Albiglutide® (GLP-1 albumin fusion)
Diabetes type II
X
Teva/ HGS Fusion + expression
Several molecules (G-CSF, BNP, …)
Bio- betters
X X X
CSL Fusion Blood coagulation factors
FIX, FVIIa, + others
X X X
Dyax Fusion + expression
Kunitz Domain proteins and antibody fragment
Several X
Publicly available information on companies using Novozymes’ 1. gen Albufuse® technology
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• Lipases
• Proteases
• Esterases/cutinases
• Oxido-reductases:
• laccases,
• peroxidases,
• Chloroperoxidase
• Amylolytic enzymes
ENZYMES FOR BIOCATALYSIS; MANUFACTURING APIS WITH ENZYMES
Advantages of enzyme manufacturing
• Higher Yields
• Shortened synthesis route
• Replaces costly chiral resolving agents
• Significant reduction in waste streams
• Stereo-, regio-, and chemo-selectivity
• Simplified processing and purification
• Fewer by-products, reducing impurities
• Mild reaction conditions
• Catalytic Reactions
• Novozymes has one of the most comprehensive biocatalysts enzyme portfolios • New focus aiming at exploring potential to become important tool for cost effective &
sustainable manufacturing of Fine Chemicals & Pharma
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IN 2014 WE WILL SEE MORE FOCUS ON A RANGE OF AREAS WITHIN NOVOZYMES BIOPHARMA
• Continued new data proving the novel half life extension platform
• More Feasibility studies with large pharma and biotech companies on the novel half life extension platform
• Growth in sales of enzymes for biocatalysis
• Solidification of Hyasis and Recombumin platforms for future growth
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• Novozymes’ products and technologies aim at supporting the healthcare industry develop better, safer and more economical treatments.
• Novozymes is the world leader in recombinant Albumin, half-life extension technologies based on albumin and recombinant hyaluronic acid.
• Novozymes’ range of recombinant enzymes enables optimization of manufacturing of a range of small molecules via biocatalytic processing
IN SUMMARY
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Recombinant Albumin USP-NF*
Half-life Extension Technology
Recombinant hyaluronic acid
• Recombumin® Prime • Recombumin® Alpha • AlbIX
• Albufuse® Flex • Recombumin® Flex
• Hyasis® • Hyasis® Link
Pharmaceutical Enzymes
• Proteases and lipases • rTrypsin for • Novel proprietary
enzymes being explored
Novozymes Biopharma: Knowledge-based solutions driving the development of innovative, safer, and more consistent medical devices and pharmaceutical products
For more information visit www.novozymes.com/investor or www.biopharma.novozymes.com
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guide 25
Svend Licht, Senior Director, Novozymes Biopharma [email protected], +45 30778891