NOVOZYMES BIOPHARMA - Euroland

EDITING SLIDES IN THE NOVOZYMES TEMPLATE

Choose Layout: Click Layout in the top menu Home. And choose between +30 different layouts.

Edit Header and footer: In the top left corner you find Slide no., Date and Header. Change settings in the menu: > Insert > Header and Footer

guide

NOVOZYMES BIOPHARMA - PRODUCTS, TECHNOLOGIES AND MARKETS

Svend Licht, Senior Director, Novozymes Biopharma

JPM Healthcare, January 16th, 2014

BASIC LAYOUT

Use: This is the basic slide with no extra Novozymes graphics added. Edit Layout: Click Layout in the top menu Home. And choose between +30 different layouts. Edit Header and footer: In the top left corner you find Slide no., Date and Header. Change settings in the menu: > Insert > Header and Footer

guide 2

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.

BASIC LAYOUT


guide 3

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

BASIC LAYOUT


guide

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%

BASIC LAYOUT


guide

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%

BASIC LAYOUT


guide

• 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%

BASIC LAYOUT


guide 7

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%

BASIC LAYOUT


guide 8

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).

BASIC LAYOUT


guide

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

BASIC LAYOUT


guide

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

BASIC LAYOUT


guide 11

NOVOZYMES’ PRODUCTS & TECHNOLOGIES

Hyaluronic Acid

Hyasis

Half-life Extension (HLE) Technology

Albufuse Flex

Recombumin Flex


Recombumin Prime

Recombumin Alpha

AlbIX

Enzymes for Biocatalysis

*Meets National Formulary (NF) standards as published by United States Pharmacopeia (USP).

BASIC LAYOUT


guide

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

BASIC LAYOUT


guide

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

BASIC LAYOUT


guide

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

http://www.hgsi.com/

http://www.gsk.com/index.htm

http://www.cslbehring.com/s1/cs/enco/1151443990667/content/1151443991017/home.htm

BASIC LAYOUT


guide

SHORT HALF-LIFE REDUCES THERAPEUTIC EFFECT

Improved pharmacokinetics to reduce dose/side effects

BASIC LAYOUT


guide

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%

BASIC LAYOUT


guide

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

BASIC LAYOUT


guide

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”

BASIC LAYOUT


guide

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

BASIC LAYOUT


guide

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

http://www.hgsi.com/

http://www.gsk.com/index.htm

http://www.cslbehring.com/s1/cs/enco/1151443990667/content/1151443991017/home.htm

BASIC LAYOUT


guide 21

• 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

http://www.google.com/url?sa=i&source=images&cd=&cad=rja&docid=-91gohf8yXJE8M&tbnid=nY4jzOty1jSCBM:&ved=0CAgQjRwwAA&url=http://images.businessweek.com/ss/05/12/bestproducts/index_01.htm&ei=eRllUeaaEMiRtAbliICIBQ&psig=AFQjCNFeNPLqreBNPNOET1ZLeDjUlQNiFw&ust=1365666553304724

BASIC LAYOUT


guide 22

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

BASIC LAYOUT


guide

• 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

23


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

BASIC LAYOUT


guide 25

Svend Licht, Senior Director, Novozymes Biopharma [email protected], +45 30778891

NOVOZYMES BIOPHARMA - Euroland

Documents

Transcript of NOVOZYMES BIOPHARMA - Euroland