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NOVOZYMES BIOPHARMA - TECHNOLOGIES AND MARKETS Dave Mead, Business Development Director, Biopharma Jefferies Health Care conference, 19 th November, 2014

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Page 1: NOVOZYMES BIOPHARMA - Jefferies 1340 2 Novozymes... · NOVOZYMES BIOPHARMA - TECHNOLOGIES AND MARKETS ... Amylolytic enzymes Peroxidases Chloropero ... WHY ENGINEER HUMAN ALBUMIN?

NOVOZYMES BIOPHARMA- TECHNOLOGIES AND MARKETS

Dave Mead, Business Development Director, Biopharma

Jefferies Health Care conference, 19th November, 2014

Page 2: NOVOZYMES BIOPHARMA - Jefferies 1340 2 Novozymes... · NOVOZYMES BIOPHARMA - TECHNOLOGIES AND MARKETS ... Amylolytic enzymes Peroxidases Chloropero ... WHY ENGINEER HUMAN ALBUMIN?

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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

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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• 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

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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

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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

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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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