life-saving anti-infective...

Life-saving Anti-Infective Treatments

Month Year

First name Last name

Job Title

2

Table of Contents

• The Company

• Competencies and Services

• Facilities and Locations

• Product Portfolio

• Vancomycin and CMS Key Anti-Infective Franchises

• Our Customers

• Our Culture

• Xellia in Summary

3

The Company

4

Xellia at-a-glance

• Specialty pharmaceutical company focused on critical care therapies for

life-threatening diseases

• Supplying both APIs and FDFs

• B2B sales to approx. 500 customers in 70 countries

• 50+ years’ expertise in supplying fermented and semi-synthetic products

that are challenging to manufacture

• State-of-the-art production facilities in the United States, Europe and Asia

with global regulatory approval and an unsurpassed compliance track record

• Continuously expanding product pipeline and geographic reach

• Wholly owned by Novo Holdings A/S and well financed with growing

sales

• 2016: Revenue at 257.4 MUSD and EBITDA increased by 56% from

2015 to 63.6 MUSD

5

Xellia’s Purpose and Goal

• Xellia’s Purpose

To save and enhance lives by leading the fight against infections

• Xellia’s Goal

To provide anti-infective

solutions against multi-drug resistant microorganisms

6

Our Heritage

Apothekernes

Laboratorium

AS was

founded by

pharmacists in

Oslo

Apothekernes

Laboratorium

started

production of

penicillin,

bacitracin and

neomycin in

Oslo

Apothekernes

Laboratorium

established in

the US; market

leader in

bacitracin

Apothekernes

Laboratorium

acquired

Dumex A/S,

Copenhagen -

bacitracin,

polymyxin B,

colistin, and

amphotericin B

Alpharma

formed by a

merger of

Apothekernes

Laboratorium

Inc,

Apothekernes

Laboratorium

AS and Dumex;

vancomycin

R&D Start-up

Alpharma

acquired SKW

Biotech,

Budapest;

vancomycin and

niche products

Alpharma API

business

acquired by 3i

and members of

management

team; Xellia is

born

Novo Holdings

A/S acquired

the majority

stake in the

Xellia

Xellia acquires

Fresenius

Kabi’s

lyophilized

(freeze-dried)

manufactur-ing

facility in

Raleigh, North

Carolina, USA

Xellia acquires

manufacturing

facility from

Hikma

Pharmaceutic-als

in Bedford, Ohio,

USA to produce

sterile

injectables. Xellia

Cleveland is

established

1903 1952 1975 1983 1994 1998 2008 2013 2014 2015

7

Our Team

• Management team: applying extensive, international pharmaceutical

experience to drive business strategies and growth

• Quality and Regulatory Affairs: ensuring highest quality standards

are met in production, products and procedures

• Research and Development: developing efficient processes, new

FDFs, innovative delivery systems and advanced analytical tools

• Manufacturing: specializing in technologically difficult manufacturing

processes including fermentation, purification, semi-synthesis and

freeze-drying

• Sales and Marketing: building strong relationships with customers,

responding with on-time delivery and premium quality products

Xellia’s highly skilled team thrive on a spirit of innovation,

excellence and teamwork

8

Our Growth Strategy

2010 2015 2020

Building on strengths

in API product franchises

Launching an injectable FDF

pipeline

Forward integration of existing APIs to injectable

FDFs

Longer term value: developing

proprietary delivery systemsPursuing an ambitious strategy in the

injectable anti-infective market targeting 8

to 10% revenue (CAGR)

9

Competencies and Services

10

R&D: Delivering Valuable Products for the Future

• Focused on “difficult-to-develop” products with an intrinsic competitive advantage

1. Increasing barrier-to-entry(IP, technologies, product mix, containment etc.)

2. Value added IP position(innovative, patent-enabling development strategies including patent positioning and filing our own applications)

3. Limited competition(specialist technology, experience and “know-how”, niche products)

4. Cost competitive(superior technology)

5. First to market(speed is essential and critical for success)

• Creating a balanced and attractive new product pipeline

11

Manufacturing and Supply Capabilities with

Exceptional Technical Support

• Excellence in manufacturing using:

• High-yielding microbial producer strains and efficient fermentation processes

• Robust purification processes, producing consistent high purity products

• Advanced analytical methods for monitoring quality and compliance to Pharmacoepial requirements

• Final handling expertise including all common drying technologies (filter-, vacuum-, freeze-, and spray-drying)

• Fill-finish capabilities for most vial sizes and high volumes

• Continuity of global supply and on-time delivery of competitively priced products

12

Contract Development and Manufacturing

Services

• Services typically confined to:

• Xellia’s current products, where there may be a need for special API

qualities or dosage forms

• Derivatives of Xellia’s current products, showing increased activity,

extended spectrum, reduced toxicity or different mode of action

• New products (including NCEs) where Xellia may exploit established

R&D and manufacturing capabilities

13

Facilities and Locations

14

Global Operations

Manufacturing sites

Sales offices

Other offices/R&D centres

Tokyo, Japan

Shanghai, P.R. ChinaZagreb, Croatia

Bangalore, India

Oslo, Norway Budapest, Hungary

Copenhagen, Denmark Taizhou, P.R. China

Raleigh, USA

Cleveland, USA

15

Xellia Manufacturing Sites

Outstanding

quality track

record

Copenhagen, Denmark

Amphotericin B

Bacitracin and Bacitracin Zinc

(sterilization only)

Colistimethate Sodium

Colistin Sulfate

Polymyxin B Sulfate

Tobramycin Sulfate

Vancomycin (HCL and Base)

Vancomycin vials

(0.5g, 1.0g, 5g, 10g)

Colistimethate sodium vials

(1 miu, 2 miu, 150 mg)

FDA: 2016

ISO 14001

OHSAS 18001

Budapest, Hungary

Daptomycin

Gramicidin

Tyrothricin

Vancomycin

FDA: 2014

ISO 14001

OHSAS 18001

Taizhou, P.R. China

Vancomycin

Bacitracin

Bacitracin Zinc

FDA: 2015

ISO 14001

OHSAS 18001

Raleigh, USA

Vancomycin

Leucovorin

Panhematin

FDA: 2017

Cleveland, USA

Commercial production

expected to commence

by 2019

16

Locations Copenhagen, Raleigh,

Shanghai and Tokyo

Service Building strong relationships

with major pharmaceutical

companies

Responding with on-time

delivery of premium quality

products

Pro-actively driving fast-to-

market entries

Sales and Marketing Offices

17

Product Portfolio

18

. . . building an attractive pipeline

based on standard dosage forms

and unique delivery systems

A Balanced Portfolio of Specialized APIs and FDFs

2010 2015 2020

Building on strength

in API product franchises

Launching an injectable FDF

pipeline

Forward integration of existing APIs to injectable

FDFs

Longer term value: developing

proprietary delivery systems

19

Product Range

Active Pharmaceutical

Ingredients (APIs)

Finished Dosage Forms

(FDFs)

Novel Device Delivery

Platforms

11 APIs

• Antibacterial agents for

treatment of Gram-positive

and Gram-negative infections

• Antifungal agents

• Sterile and non-sterile API

qualities

9 FDFs

• Injectables

- Available in dry powder

fill or freeze-dried vials

- Packaging

- Labelling

• Capsules

• Inhalation

3 Novel Device Delivery Platforms

• Aqueous Droplet Inhaler (ADI)

• Ready-To-Use (RTU) infusion

bags

• SmartPak infusion bags

20

Novel Device Delivery Platforms

Aqueous Droplet

Inhaler (ADI)

SmartPak infusion

bags (”jumbo vial”)

Ready-To-Use (RTU)

infusion bags

• Short administration time

• Portable (pocket size)

• Same efficacy at

significantly lower dose

of drug

• Reduced side effects –

no coughing

• Handled by PharmAero

(Xellia / Scandinavian

Health Joint Venture –

see next slide)

• 100g drug versus

standard 0.5-10g (eg.

Vancomcyin)

• Ease of drug

administration in

hospitals

• Co-operation with ACS

Dobfar (Italy)

• Drug and diluents in one

dual chamber infusion

bag

• Hospital use

• Less use of hospital staff

time

• Reduced risk of mistakes

in mixing and dosing

• Improved healthcare

worker safety

21

Pharmaero – a Xellia joint venture

• A 50:50 joint venture between

Xellia ApS and SHL GROUP

• Pharmaero signs contracts with

other pharmaceutical companies

who wish to use the ADI platform

for their inhalation product

• Scandinavian Health Limited

• Develop and manufacture

advanced drug delivery devices

such as auto

injectors, pen injectors and

inhalers

• The ADI is designed for delivery

of larger amount of fluids for a

soft mist aerosol inhalation

• The development of the ADI has

been driven by Xellia and SHL

Group

• TobraAir and ColistAir are the

first two Xellia products for the

ADI

• Xellia will develop further new

antibiotic solutions for the ADI

22

Tobramycin

vials

Amphotericin B

Forward Integration from API to FDF

Tobramycin

Sulfate

CMS

Colistin

Polymyxin

Vancomycin

HCl

BacitracinBacitracin

Zinc

Tyrothricin

Daptomycin

Polymyxin

vials

AP

I

CMS

vials

FD

F

Attractive FDF pipeline

in developmentVancomycin

vials

Vancomycin

caps

Bacitracin

vials

Daptomycin

vials

Gram-Negative

Antibacterials

AntifungalsGram-Positive

Antibacterials

Vancomycin

Base Gramicidin

23

Development Pipeline and Filings

. . . continuously growing

the pipeline beyond 2015

• Since 2008, Xellia has shown an impressive

increase in the number of new product filings

24

SuperGenerics

(ADI and RTU)

Injectable Patent Challenges

(P.IVs)

Injectable Specialty Generics(containment products like

penems and oncology)

Injectable Regular Generics(antibacterials and antifungals)

Xellia’s Balanced Pipeline – Products with an Intrinsic Competitive

Advantage

25

Key facts In the USA, vancomycin is used for treatment of more than 70% of infections caused by methicillin-resistant strains of Staphylococcus aureus (MRSA) and more than 30% of Clostridium difficile treatments

Description Glycopeptide antibiotic

Active against a wide variety of Gram-positive bacteria

Target Staphylococcus ssp. including MRSA

Streptococcus ssp.

Clostridium difficile

Administration Injection

Oral

Vancomycin

– Critical in Modern Medicine

26

Vancomycin and Colistimethate Sodium (CMS)

. . . two of our life-saving anti-infective franchises

27

Colistimethate Sodium (CMS)

– Emerging as a Sole Effective Antibiotic

Key facts Important treatment for pulmonary infections associated with critical and chronic

diseases e.g. cystic fibrosis (CMS market larger in EU and ROW than USA)

Description Lipopetide antibiotic, prodrug of colistin

Active against Gram-negative bacteria

Target Acute Pseudomonas aeruginosa and Acinetobacter baumannii infections

Multiple Drug Resistant (MDR) Gram-negative infections (only treatment option)

Administration Inhalation

Injection

28

Our Customers

29

Global Customer Base

• Long-standing international customer base: ~500 active customers

• Top 20 customers account for 60% of sales

50% big and

specialty

pharma

50% generic

companies

30

Worldwide Sales

• Undisputed leader in the US and Europe for products within Xellia’s product portfolio

• Holds 62 market authorizations in total, allowing business to grow in key markets

Asia

7%

Europe

29%

Latin

America

5%

USA

Canada

55%

Middle

East

4%

31

Our Culture

32

Xellia’s Values and Behaviors

To save and

enhance lives

by leading the

fight against

infections

To provide anti-

infective

solutions

against multi-

drug resistant

micro-

organisms

I bring out the best

in myself and

others

I am accountable

to customers,

partners and to

colleagues

Our Zest is what

makes

us uniqueI mean what I say

and I say what I

mean

Being

Our Best

Accountability

Zest

Openness &

Transparency

33

Protect the Patient - Protect our Environment

• Quality underpins every aspect of our

business

- Demonstrated at every stage of product development,

manufacture and distribution

• We continually endeavour to improve our

social, ethical, environmental, health and

safety responsibilities

- In full compliance with external laws and regulations

• We constantly work to ensure that Xellia

operates in a responsible manner

34

Responsiblity to Society – A partnership with

SOS Children’s Villages

• From January 2015 to January 2018, Xellia has entered a partnership with SOS Children’s Villages

to provide full funding to the SOS Children’s Villages

Kenya Eldoret Medical Centre.

• At the Eldoret Medical Centre:

- 10 employees

- 6000 patients annually

- Most common ailments: infections,

Malaria, HIV and waterborne diseases

- Other outreaches: cancer screeening,

HIV-testing, Malezi bora,

door-to-door campaigns

• The medical centre works to treat,

increase education and prevent

life-threatening diseases within the community.

35

Responsiblity to Society - Xellia and SOS Children’s

Villages

• “It’s in our corporate DNA to help people in need, as we strive to contribute with the development of

medicines to fight life-threatening diseases and ultimately save lives. The partnership with SOS Children’s

Villages is felt by us as a natural fit for our company.” Carl-Åke Carlsson, CEO and President at Xellia

• At Xellia, we look forward to embarking on the journey alongside the SOS Children’s Villages Medical

Centre in Eldoret Kenya, to reach less fortunate patients and provide them with the possiblity for a brighter

and healthier future.

• At Xellia, a variety of activities will be placed into action during 2015 in order to launch our partnership with

the SOS Children’s Villages and bring awareness to our social responsibility.

36

In Summary . . .

37

Proven Track Record of Continued Growth

2000 2005 2010 2015 2020

FDF

API

Total Revenue (MUSD)

70

~200

220

~500

135

38

Xellia - A Trusted Provider of Life-Saving Anti-Infective

Treatments

• International specialty pharmaceutical company

• Supplying both APIs and FDFs to approx. 500 customers in 70

countries

• 50+ years’ expertise in supplying fermented and semi-synthetic

products that are challenging to manufacture

• State-of-the-art production facilities with global regulatory

approval and an unsurpassed compliance track record ensuring

continuity of supply and on-time delivery of competitively priced

products

• Continuously expanding product pipeline and geographic

reach

39

Appendix

40

Worldwide Leading Supplier of Difficult to Produce

Anti-Infectives

APIs and FDFs Vancomycin

Colistimetathe Sodium

(CMS) Polymyxin B Bacitracin Amphotericin B

Type • Glycopeptide

antibiotic

• Lipopeptide

antibiotic

• Lipopetide antibiotic • Polypeptide

antibiotic

• Polyene antibiotic

Target • Bacteria (Gram-

positive)

• Bacteria (Gram-

negative)

• Bacteria (Gram-

negative)

• Bacteria (Gram-

positive)

• Fungi

Overview • Gold standard

treatment of severe

Staphylococcus

aureus infections

(incl. MRSA) and

Clostridium difficile

enteritis

• Primary use i.v. and

as capsules

• Gold standard

treatment in EU for

lung infections in

cystic fibrosis

• Primary use in

nebulisation and i.v.

• Acute infections

Pseudomonas

aeruginosa and

other serious

infections

• Active against

staphylococci,

streptococci and

clostridia

• Active against wide

variety of fungi i.e.

Severe mycosis

• Multiple dosage

forms i.e. i.v.

(liposomal and

regular), semi-solid,

capsules / tabs

41

Product Range

Antifungals

API Amphotericin B

Gram-Positive

Antibacterials

API Vancomycin HCl

Vancomycin Base

Daptomycin

Bacitracin

Bacitracin Zinc

Tyrothricin

Gramicidin

FDF Vancomycin vials

Vancomycin caps

Bacitracin vials

Daptomycin vials

Gram-Negative

Antibacterials

API Tobramycin Sulfate

Polymyxin B Sulfate

CMS

Colistin

FDF Tobramycin vials

Polymycin vials

CMS vials

Products protected by valid patents are

not offered for sale in countries where

the sale of such products constitutes a

patent infringement.

42

Xellia Strategic Map - Transformation for the Next

Level Growth

COREAPI Technology FDF

Technology

Therapeutic Focus

Customer Segment

Lyophilization Lyo vials

Dry vials

B2B

Infectious diseases

Generics

Regular

Generics

Fermentation & purification

NCEs / ICEsBased on current

portfolio

Ophthalmology

Semi-synthesis

ADI Inhalation

RTU Bag system

Oncology

Super-

Generics

Generics Value Chain

PharmaValue Chain

Inflammation

Xellia core

Xellia in development

Xellia under evaluation

B2B

B2B

ADE

Ophthalmics

Value

Generics(Paragraph

IV)

43

Ixabepilone

Ixabepilone

vials

Temsirolimus

vials

Tobramycin

Sulfate

Tobramycin

Base

CMS

Colistin

Polymyxin

Vancomycin

Mupirocin

Bacitracin

Bacitracin

Zink

Tyrothricin

Gramicidin

Vancomycin

vials API

FDF

Amphotericin B

Gram-Negative

Antibacterials

Daptomycin

Vancomycin

caps

Bacitracin

vials

Daptomycin

vials

Polymyxin

vials

API

Tobramycin

vials

CMS

vials

FDF

API

FDF

Product Portfolio Targeted at Critical Care Space (Anti-infectives

and Oncology)

Gram-Positive

Antibacterials

Antifungals

Ertapenem

vialsDoripenem

vials

Ertapenem

vials

Doripenem

vials

Micafungin

Anidulafungin

Micafungin

vials

Anidulafungin

vials

Voriconazole

vials

Oncology

APIFDF

44

PipelineAPI #7

Pipelinevials #7

Pipelinevials #8

Tobramycin

Sulfate

Tobramycin

Base

CMS

Colistin

Polymyxin

Vancomycin

Mupirocin

Bacitracin

Bacitracin

Zink

Tyrothricin

Gramicidin

Vancomycin

vials API

FDF

Amphotericin B

Gram-Negative

Antibacterials

Daptomycin

Vancomycin

caps

Bacitracin

vials

Daptomycin

vials

Polymyxin

vials

API

Tobramycin

vials

CMS

vials

FDF

API

FDF

Product Portfolio Targeted at Critical Care Space (Anti-infectives

and Oncology)

Gram-Positive

Antibacterials

Antifungals

Pipelinevials #1

Pipeline

vials #2Pipeline

vials #3

Pipeline

vials #1

Pipeline

vials #2

Pipeline

vials #3

Pipeline

API #4

Pipeline

API #5

Pipeline

vials #4

Pipeline

vials #5

Pipeline

vials #6

Oncology

APIFDF

45

Copenhagen, Denmark

Operations Corporate Headquarters

Manufacturing

R&D

Sales

Products Amphotericin B

Colistimethate Sodium

Colistin Sulfate

Polymyxin B Sulfate

Tobramycin Sulfate

Vancomycin

Regulatory FDA: 2016

ISO 14001

OHSAS 18001

Employees 612 FTEs

46

Raleigh, USA

Operations US Headquarters

Manufacturing

Sales

Products Vancomycin

Leucovorin

Panhematin


Employees 126 FTEs

47

Budapest, Hungary

Operations Manufacturing

R&D

Products Daptomycin

Gramicidin

Tyrothricin

Vancomycin


ISO 14001

OHSAS 18001

Employees 254 FTEs

48

Cleveland, USA


Commercial production expected to

commence by 2019

Employees 133 FTEs

49

Taizhou, P.R. China


Products Vancomycin

Bacitracin

Bacitracin Zinc


ISO 14001

OHSAS 18001

Employees 212 FTEs

50

Zagreb, Croatia

Operations Finished Dosage Form (FDF) R&D Center

Development of innovative and patent

enabling formulation strategies

Employees 99 FTEs

51

Oslo, Norway

Operations Active Pharmaceutical Ingredient (API)

R&D Center

Development of innovative and patent

enabling API process strategies

Employees 42 FTEs

52

Mikkel Lyager Olsen

Chief Legal Officer and Vice

President

Daniel Schwartzlose

Vice President

Strategic Planning and

Corporate Development

Kristin Lund Myrdahl

Branding and

Communications Management

Management Team

Management Team

Carl-Åke Carlsson

Chief Executive Officer and

President

Mads Bodenhoff

Chief Financial Officer and

Senior Vice President

Geelanie R. Briones

Vice President

Quality

Extensive Pharmaceutical Industry Experience

Aleksander Danilovski

Chief Scientific Officer and Senior

Vice President Global R&D and

Regulatory affairs

Bjørn Thonvold

Vice President Human Resources

Gaël Bernard

Senior Vice President Sales and

Marketing

53

Benny D. Loft

Board Member

Julie McHugh

Board member

Henrik Kjær Hansen

Board member

Board of Directors – Key Industry Players Providing

Counsel and Support

Steen Riisgaard

Chairman of the Board

Andreas Rummelt

Board Member

Per Valstorp

Board Member

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