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Agenda

• Companies introduction

• NextPharma skills and capabilities

• Explore how we can work together

Company introduction

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NextPharma at a glance

Leading European pharmaceutical CDMO focused on attractive technology niches

>€200 million revenues

5 to 7%LTM annual growth

Regulated byFDA (USA)

EMA (Europe)

Anvisa (Brazil)

ROW

Manufacturing facilities

Logistics

sites

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4 60+End markets served

>1,400Employees

24%In Quality roles

ProductsSolids / Pellets

Hormones

Liquids / semi-solids

Penicillins / Cephalosporins

Ophthalmics

Our 7 Centres OfExcellence

Now with over 150 customers across 6

continents

London, UK• Head Office

Limay, France• Liquids

• Suppositories

Bielefeld, Germany• Modified Release

• Analytical Services

Göttingen, Germany• Solids

• Clinical Trials Services

Berlin, Germany• Penicillins

Waltrop, Germany• Hormonal solids & semi-solids

• Semi-solids

Göttingen, Germany• Cephalosporins

Tampere, Finland• Ophthalmics (BFS + 3P)

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How NextPharma has successfully grown organically

Positive differentiators of NextPharma in our industry

Project management & excellent product transfers

Customer-focused reputation

Synergies between production & development

Financial stability

Flexible partnerfast to act / lean

Local and globalperspective

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Continues focus on solid Organic growth

Commercial and operational successes, and investment in growth

✓Continuous strong revenue and EBITDA growth

✓ Long term vision though customer contract extensions and new business wins

✓High Quality standards: Successful FDA re-inspections

✓Best in class operations with key investments in our sites:

• Successful refurbishment of Berlin (dedicated Penicillins site)

• Goettingen : major capacity extension for solid dosage forms

• Tampere : new High speed BFS Unidose line

• Packaging line at Waltrop and Berlin

• New liquid filing line at Limay

• Logistics expansion

Skills and Capabilities

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Equipped and ready to support you along the entire product lifecycle

Clinicalsupply Commercial

API

Pharmaceuticaldevelopment

• Formulation and process development

• Analytical method development

• Stability testing

• Clinical batch manufacture

• Phase I – IV clinical trials supply

• Validation batches

• Technology transfer

• Launch and supply

CMC regulatory affairs

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Pharmaceutical Development ServicesAlways tailored to your precise needs

✓ Depth of scientific knowledge applied to

your project

✓ Scientific and regulatory advice

✓ Direct, fast communication through

your dedicated project manager

✓ Seamless links to your clinical and

commercial supply

✓ Flexible approach to your evolving needs

API, comparator, excipient sourcing and testing

Pre-formulation and formulation development

Analytical method development

Microbiological testing

Manufacture, packaging and distribution of clinical supplies

Scale-up and process development

Analytical method validation and stability registration

Technology transfer to production

Compilation of CMC modules for CTAs, CTDs, NDAs, INDs dossier submission and variations

QP release

In Summary

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Pharmaceutical Development Services

With diversified services

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Optimisation of composition and manufacturing process

Product Development

Full characterisation / reverse engineering of related products

(if required)

Process development and validation

Quality by design including quality target product profile, gap analysis and

risk assessment

Formulation and manufacturing process strategy tailored to individual

project requirements

Product Optimisation Scale-up and process delivery

Supportive stability and stress studies on prototype formulations

Scientifically guided setup of product specifications

Analytical method development and method validation

Manufacturing of registration batches

ICH stability studies

Our across-site highly-skilled development team enables us to provide a maximum level of service and competence for every single project.

Full ICH validation of analytical methods

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Analytical Services

✓ Depth in scientific knowledge

✓ Scientific and regulatory advice

✓ Consistent high quality to EMA, FDA, ANVISA, ICH

✓ Direct, fast communication through a dedicated

project manager

✓ State-of-the-art laboratory and equipment

✓ >25 years experience as Analytics provider

✓ High flexibility to your evolving needs

Analytical Chemistry for raw materials, bulk and finished

products

QP Release

Method development, validation and transfer

Stability storage and testing

Microbiology

Key Services

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Clinical Trials Supply services

From an experienced CTS partner that understands your needs may evolve

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Modu-C station | Göttingen, Germany

NextPharma CTS

A truly flexible approach to ensure your project keeps right on track

Seamless links to development and commercial supply

Always reliably informed with an experienced and dedicated project manager

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Clinical Trials Supply ServiceOur Full Services offer

Clinical ManufacturingPackaging & Labelling

Storage & Distribution Regulatory Support

❖Blinding/Encapsulation capabilities for all major dosage forms

❖Primary and secondary packaging of solids, semi-solids, liquids

❖ Labelling and secondary packaging of injectables and other dosage forms

❖Kit packaging

❖Randomisation

❖Manufacturing capabilities for IMPs and placebos

❖ Logistics solutions meeting CGSP/GDP regulations

❖ Storage at controlled temps 15-25°c | 2-8°c | -20°c

❖ Storage of controlled substances

❖Worldwide distribution at controlled temperatures

❖Return and reconciliation

❖Creation of IMPD/IND

❖QP Auditing / QP Release

❖ Import and export of IMPs and controlled substances from and into third countries

❖Randomisation lists and emergency letters

❖Also, comparator sourcing

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Commercial ManufacturingExperts in solids, semi-solids and liquids

SolidsPowders for Suspensions

Pellets TabletsFilm Coated

TabletsHard Gelatine

Capsules

• Dry syrups• Bottles• Sachets

• Taste masking• Modified release of API• Protection of API

• Compressed Powder• Compressed Granules • Compressed Pellets • Bi-layer (2 different blends

compressed in one tablet)• Modified release matrix tablets• Orodispersible• Mini-tablets

• Coating for taste masking

• Coating for modified release of API

• Coating for protection of API

• Powder blend in capsules• Granules in capsules • Pellets in capsules• Tablets in capsules

M o d i f i e d R e l e a s e

Liquids• Buccal sprays• Topical sprays• Nasal sprays• Oral solutions & Suspensions in bottles or ampoules• Eye drops (BFS Single Dose & Multi Dose + 3 P & PFMD bottles)

Semi Solids• Topical gels & creams• Ointments• Suppositories

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Regulatory StatusCentres of Excellence Responding to the WorldwideHighest Quality Standards

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Berlin

Bielefeld

Göttingen

Limay

Waltrop

Tampere

Anvisa(Brazil) EMA

FDA(USA)

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Why select NextPharma as your partner?

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Service

✓ Strong, secure

foundations

✓ Demonstrating innovation

and world-class technical

skills

✓ Modern outlook /

facilities

✓ Competitive

Speed

✓ Recognised by customers

for delivering a fast

response

✓ Ability to react and

deliver the ‘smart’

solution

Passion

✓ Proven excellence

creating client specific

solutions

✓ Depth of understanding

and flexible approach

✓ Application of

enthusiastic scientific

expertise

✓ Proactive communication

S m a r t e v e r y t i m e

nextpharma.com