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NOVOZYMES BIOPHARMA - PRODUCTS, TECHNOLOGIES AND MARKETS
Rose A. Lance, Novozymes Biopharma
Jefferies Healthcare Conference, June 2-5, 2014, 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 Apr, 2014
Founded 1925
Listed 2000
Ticker NZYM B
Exchange Copenhagen
Market Cap* US$ 15bn
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: $2.1bn/€1.5bn in sales and 24.7% EBIT margin in 2013
Majority owner Novo A/S controls 25.9% of the capital and 70.5% of the votes
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Bioenergy
• Corn ethanol • Cellulosic biofuels
• Unique biotech-focused business with a strong legacy of delivering growth, earnings, and cash flow
• ~13-14% of annual sales invested in R&D
• Global provider of enzymes to all market segments creates global market leader position
• 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
16% 36% 27% 14% 7%
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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 stable
liquid formulations
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Novozymes provides solutions to: Stabilize drugs
Improve formulation
Improve dosing regime
Increase patient compliance
Reduce manufacturing cost
Novozymes Focuses on Supporting Drug Development
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Novozymes’ Products and Technologies Support Pharma Companies in Their Development
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
• Next generation albumin-based technology to create longer-lasting drugs through albumin fusion or chemical conjugation
• Improved dosing regimes for increased patient compliance
• 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
• Comprehensive biocatalysis enzyme portfolios including lipases, proteases, esterases, oxido-reductases and amylolytic enzymes
• Improved yields, simplified processes and fewer byproducts in API manufacturing
Hyaluronic Acid Recombinant Albumin USP-NF*
VELTIS® Enzymes for Biocatalysis
Novozymes
Drug Discovery Drug
Development Manufacturing Distribution
Sales and Marketing
The classic pharma value chain
*Meets National Formulary (NF) standards as published by United States Pharmacopeia (USP).
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Benefits • Proven clinical performance • Long patent life • Flexible and scalable manufacturing by fusion or conjugation in a variety of expression hosts • Patient-friendly dosing and low risk of adverse events • Provided by technology developer with strong heritage and track record in albumin supply
Novozymes’ Half-Life Extenstion Platform: VELTIS®
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Short Half-Life Reduces Therapeutic Effect
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Improved pharmacokinetics to reduce dose/side effects
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Has a naturally long plasma half-life of ~19 days for well understood reasons:
• Size - retained by kidney/glomerulus
• FcRn (neonatal Fc receptor) binding: pH-dependent recycling “rescues” albumin from degradation and prolongs half-life
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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 recycling
Albumin -FcRn recycling 60%
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Albumin is the Ideal Vehicle for Half Life Extension
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• Veltis 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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Increased receptor affinity >2X albumin half-life in a range of models
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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
No Significant Immunogenicity Predicted From a Range of Screening Tools
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- 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”
Veltis albumin variants
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Veltis® Offers a Potential Route to Once-Monthly Dosing
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Optimise your protein or peptide for: Control of dosing
intervals and size Reduced toxicity Improved efficacy
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Company Deal Drug Target Pre-clin
PI PII PIII MAA stage
Fusion + expression
Several molecules (G-CSF, BNP, …)
Bio- betters
X X X
Fusion Blood coagulation factors
FIX, FVIIa, + others
X X X
Fusion + expression
Kunitz Domain proteins and antibody fragment
Several X
Publicly available information on companies using Novozymes’ VELTIS® technology:
A Number of VELTIS® Candidates are in Clinical Development
Albiglutide® (GLP-1 albumin fusion) for diabetes type II, approved in both the EU and the US in 1H 2014
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• Lipases
• Proteases
• Esterases
• Oxido-reductases:
• laccases,
• peroxidases,
• Chloroperoxidase
• Amylolytic enzymes
Advantages of enzyme manufacturing
Improved productivity
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
Sustainable process
• Novozymes has a comprehensive enzyme portfolio for biocatalysis
• New focus as an important tool for cost effective and sustainable manufacturing of Fine Chemicals and Pharma
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Enzymes for Biocatalysis: Manufacturing APIs with Enzymes
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Key Advantages of Biocatalytic Route
Chemical Synthesis Biocatalytic Route
Low protein loading (0.8%) Resolution at first stage - wrong
isomer can be recycled High throughput All reactions conducted in water E-factor improved from 86 to 17
Starting material reduction by 800 Mt (cumulative)
Drastic reduction in solvent usage Mandelic acid usage - 500Mt
eliminated (cumulative) Energy usage reduced by 83%
Improvements due to replacing chemical process with chemoenzymatic reaction
Inefficient Resolution at racemic
Pregabalin stage
Pregabalin Biocatalytic Route
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Source: Organic Process Research & Development 2008, 12, 392-398
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In Summary
• 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
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Recombinant Albumin USP-NF*
Half-life Extension
Recombinant hyaluronic acid
• Recombumin® Prime • Recombumin® Alpha • AlbIX
• Veltis®
• 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
Rose A. Lance, Novozymes Biopharma raln@novozymes.com, +01 203-878-4436
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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
Allows 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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In 2014 we are focusing 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
• Solidify Hyasis and Recombumin platforms for future growth
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