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NOVOZYMES BIOPHARMA- TECHNOLOGIES AND MARKETS
Dave Mead, Business Development Director, Biopharma
Jefferies Health Care conference, 19th November, 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 within Novozymes’ core areas.
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NOVOZYMES –THE WORLD LEADER IN BIOINNOVATION
HouseholdCare
Food & Beverages
BioenergyAgriculture
& FeedTechnical & BioPharma
Who are we?
*A+B shares August, 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 capitaland 70.5% of the votes
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• BioPharma
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16%36% 27% 14% 7%
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PHARMA OVERVIEWFOUR TECHNOLOGY OFFERINGS
Existing business Emerging business
VELTIS® Hyaluronic Acid
Albumin-based technology for half-life extension through albumin fusion or chemical conjugation.
Bacillus-derived hyaluronic acid to be used as an ingredient in medical devices and pharmaceutical products.
Benefits:• Improved dosing
regimes • Increased patient
compliance• Natural alternative to
existing technologies
Benefits:• Superior safety• Consistency• Minimised risk
Drug DiscoveryDrug
DevelopmentManufacturing Distribution
Sales and Marketing
The classic pharma value chain
Novozymes
Enzymes forBiocatalysis
Recombinant Albumin
Enzyme portfolio used as catalysts for the production of pharmaceuticals.
Recombinant albumins used as ingredients to stabilise drug and vaccine products and in medical devices.
Benefits: • Improved yields• Simplified processes• Fewer byproducts in
API manufacturing
Benefits:• High consistent
quality • Safe and animal-free
HYALURONIC ACID
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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BIOCATALYSIS;MANUFACTURING API’S WITH ENZYMES
Advantages of using Biocatalysis
• 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 has become important tool for cost effective & sustainable manufacturing of Fine Chemicals & Pharma
• Used in existing manufacturing processes by Big Pharma (Pfizer etc.)
Pharma Enzymes
Lipases Proteases
Esterases
Cutinases
LaccasesAmylolyticenzymes
PeroxidasesChloropero
xidase
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WE SELL ALBUMIN IN TWO MAJOR SEGMENTS
Albumin stabilises the drug in the vial
1) Stabilising effect on peptides, proteins and vaccines
2) Allows liquid presentations for patient convenience and compliance
Albumin ensures the drug gets to the site of the disease and improves effect of drug
1) Proteins/Peptides: Keeps them in circulation for a long time (half-life extension)
2) Small molecules (oncology): Targets them to site of action
“Albumin”
Drug formulation
Drug delivery
KEY BENEFITS FROM BUYING NOVOZYMES’ ALBUMIN
For Developers
• Superior drug candidates over existing drug
• Enhanced stability in manufacturing & formulation
• New IPR opportunities from Veltis and around novel molecules
For Manufacturers
• Optimised for our yeast expression platform
• Increased yields of poorly expressed proteins
• Animal-component free process
• Proven at cGMP and manufacturing scale
• Fusions require no post-production or conjugation losses
For Patients
• Less frequent administration
• Improved efficacy and reduced side effects
• Better tolerance
• Improved compliance
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VELTIS® – THE DEFINITIVE CHOICE FOR HLE
All you need to do is define your
dosing regimen
Toxic levels side effects
Effective Dose
Ineffective Dose
Days
160 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Blo
od
co
ncen
trati
on
Maximum desired dose
Minimum effective dose
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Veltis® is an albumin based drug delivery technology that improves efficacy and patient compliance based upon the natural transportation properties of albumin
Control dose frequency and quantity to achieve optimal tolerability and efficacy
Veltis delivers outstanding performance from the albumin experts:
Science & know-how
Regulatory & technical support
Credible route to commercial manufacture
Long life IPRs
• Approved in GSK’s Albiglutide
Time
Seru
m C
oncentr
ation
The pharmacokinetics of albumin fusions and conjugates are typically lower than that of albumin alone
Improve control over the final half-life of albumin fusion or conjugate with Veltis ® engineered albumin to achieve monthly, two-weekly, or weekly peptide or protein drug dosing
Define therapeutic dosing window by balancing dose size and frequency to achieve optimum efficacy and tolerability
Note, the ‘active’ molecule added to albumin has a determining impact on PK
WT Albumin
WT Albumin-fusionFree Drug
WHY ENGINEER HUMAN ALBUMIN?
Illustrative PK curves
Veltis® Albumin-fusion
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VELTIS® ALBUMIN EXTENDS THE PHARMACODYNAMICS OF EXENATIDE BEYOND THAT OF WT ALBUMIN
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IMPROVED DOSING RECOMBINANT FACTOR IX-FUSION PROTEIN
Fig. 3 Baseline-corrected factor IX activity following 25 IU/kg infusion of the recombinant fusion protein linking coagulation factor IX with
albumin (rIX-FP) compared with 50 IU/kg prior factor IX (data from phase I and phase I/II studies) pdFIX, plasma derived factor IX .;
rFIX, recombinant factor IX.
Uri Martinowitz , Aaron Lubetsky
Phase I/II, open-label, multicenter, safety, efficacy and PK study of a recombinant coagulation factor IX albumin fusion
protein (rIX-FP) in subjects with hemophilia B
Thrombosis Research, Volume 131, Supplement 2, 2013, S11 - S14
http://dx.doi.org/10.1016/S0049-3848(13)70152-X
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Partner DrugFeasibility
Pre-clin PI PII PIII MA
Market
Tanzeum/Eperzan (Albiglutide)- GLP1 for Diabetes
Egranli Balugrastim (Neugranin)- Biosimilar for cancer treatment
rIX-FP - Once weekly for Haemophilia B
rVIIa-FP - Novel drug for Haemophilia A & B
rvWF-FP – Novel drug for Haemophilia Von Willebrand Factor
N/A
N/A
Tregitope
Large pharma #1
Not disclosed
Large pharma #2
Not disclosed
Biotech #1 Not disclosed
Biotech #2 Not disclosed
VELTIS® PIPELINE – CANDIDATES USING NOVOZYMES ALBUMIN TECHNOLOGY FOR HALF-LIFE EXTENSION
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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
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
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