Corporate Presentation November 2015 A world-class allergy ......2 Source: Summary of product...

A world-class allergy and asthma specialty biopharma business

Corporate PresentationNovember 2015

2Disclaimer

Neither this presentation nor any verbal communication shall constitute, or form part of, any offer, invitation or inducement to any person to underwrite, subscribe for, or otherwise acquire or dispose of, any shares or other securities in Circassia Pharmaceuticals plc (“Circassia”).

Forward-looking statements

This presentation and information communicated verbally to you may contain certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of Circassia. The use of terms such as “may”, “will”, “should”, “expect”, “anticipate”, “project”, “estimate”, “intend”, “continue”, “target” or “believe” and similar expressions (or the negatives thereof) are generally intended to identify forward-looking statements. These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors which could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Nothing contained in this presentation or communicated verbally should be construed as a profit forecast or profit estimate. Investors or other recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. Circassia undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.

3

Strong broad-based specialty biopharma business

− 2 currently marketed products sold to allergy / asthma specialists

− 12 products in development for allergy, asthma and COPD

− Lead allergy candidate in phase III (data expected Q2 2016)

− Lead asthma product filed Q3 2014

− Potential for 8 product launches by end 2021

Commercial infrastructure focused on allergy / asthma specialists

− Focused commercialization strategy

− Direct to specialists in key markets and partner in primary care

− Scalable infrastructure to optimize launch of lead allergy product and broader portfolio

Strong growth platform

− Immediate revenues, near-term pipeline and high-value specialty products

− Novel short-course immunotherapies have potential to revolutionize multi-$bn allergy market

− Fully funded to deliver pipeline (£209.3m cash1 at 30 September 2015)

Circassia overviewBuilding an allergy & asthma champion

1 Cash, cash equivalents and short-term bank deposits (unaudited)

4

Circassia’s strategyBuilding a self-sustaining specialty biopharma company

Deliver the pipeline

Build broad and

balanced portfolio

Market specialty products

Independently in N America

and major EU markets

Partnerships elsewhere

5

Product 2015 2016 2017 2018 2019 2020 2021

NIOX MINO®

NIOX VERO®

PSX1001*

Flixotide® substitute

PX1439*

Serevent® substitute

PSX2005

Seretide® substitute

Cat SPIRE

PSX1050*

Flovent® substitute

Grass SPIRE

House Dust Mite SPIRE

PSX3001

Novel triple presentation

Ragweed SPIRE

PSX1002

Novel LAMA formulation

Strong, deep and balanced pipeline

*Partnered1Approval / launch reflects estimates of MHRA review and decentralized procedure timelines only

All timelines are forward-looking projections that involve risks and uncertainties – please see the disclaimer on slide 2 for further details

Launched

Launched

EU1

launchUK1

launch

UK filing

UK launch

UK filing

UK launch

Ph III data

EU / US filing

EU / US launch

Partnered – timelines not disclosed publicly

Ph III data

EU / US filing

EU / US launch

Ph II data

Ph III data

US filing

Ph III data

Ph III data

EU / US filing

EU / US launch

Ph II data

Ph III data

US filing

Ph II data

UK1

approval

EU launch

US filing

EU launch

Pipeline does not show earlier-stage programmes: Birch SPIRE, Japanese cedar SPIRE, Alternaria SPIRE and home use NIOX® device

PK study

US filing

US launch

US launch

US launch

6

Corporate administration

(Finance, HR, IT)

Business analytics

Compliance (legal, regulatory)

Market access

Medical affairs

Marketing

Sales

Supply chain / distribution

Focused commercialization strategyTargeting direct sales in US & major EU markets

Direct

sales

force

Partner

sales

force

KOLs

Allergists Asthma

specialists

Primary care

Top prescribers primary care

Circassia US & EU commercial operations

Outside US and Europe

Primary care

Partner elsewhere

7

Marketed products

Asthma / COPD pipeline

Novel allergy immunotherapies

1

2

3

Summary

4

8

Products marketed around the worldDirect sales infrastructure in US and EU’s largest allergy market

Direct sales Distributors

Direct sales targeting allergy /

asthma specialists in key markets

Opportunity to expand in EU

Broad international distribution

network

Novel products

9

Only point-of-care device available across major markets to measure FeNO to assist

diagnosis and management of asthma

– Strong IP with 72 granted patents in US, EU & Japan with protection currently to 2026

Asthma is one of largest healthcare burdens

− 25 million asthmatics in US

− 14 million physician office / 1.8 million ER visits in US with asthma as primary diagnosis

− >$50bn medical cost of asthma in US in 2007

Clinical evidence shows FeNO measurement improves asthma management

– Improves diagnosis

– Improves determination of inhaled steroid responsiveness

– Improves control through tailoring inhaled steroid use

– Improves monitoring of treatment compliance

– Potential to reduce exacerbations

Extensive big pharma use in asthma clinical studies

− Validates the importance of FeNO in asthma

− Helps establish FeNO in market and train physicians in use of products

Leadership in FeNO asthma managementMeeting key clinical need in major therapeutic market

10

Next generation roll-out underwayProduct improvements offer major opportunity

NIOX MINO®

EU 2004, US 2008,

China 2010, Japan 2013

For ages 4+ in EU; 7+ in US

10 second test; 90 second result

Monitor lasts 3 years or 3,000 tests

Limited portability

For ages 4+ EU; 7+ in US

Fully portable; enhanced screen interface

6 and 10 second test; ~60 second result

Monitor lasts 5 years or 15,000 tests

NIOX VERO®

EU 2013, US 2014,

Japan 2015, China 2015

Transition to next

generation product

provides major

opportunity

Long-term upside potential from home use device currently in planning

11

Endorsement from key organizationsIncluded in ATS treatment guidelines and NICE recommendation

12

Potential to accelerate growthFoundations in place to boost NIOX® sales

2015 positioned for growth

Significant progress in establishing new market category and changing existing paradigm

FeNO accepted by KOLs and specialists

Number of major guidelines include FeNO

Scientific evidence / publications support use of FeNO

Reimbursement established (64% US coverage; targeting 75% by 2016)

Next generation NIOX VERO® device offers significant improvements over predecessor

NIOX VERO® US and Japanese launches H1 2015

Chinese NIOX VERO® launch H2 2015

13

Significant market opportunityIdeal fit with Circassia’s commercialization strategy

US specialist opportunity

$190m

US primary care opportunity

$610m

Direct

sales

force

Partner

sales

force

KOLs

Allergists Asthma

specialists

Primary care


18% CAGR over

last 5 years

Q1-3 2015

revenues £13.6m

30% growth vs

Q1-3 2014

Targeting strong

full year growth

Robust global

revenue growth

14

Marketed products



1

2

3

Summary

4

15

Near-term pipeline & longer-term novel formulations

‒ 73.5% of pre-entry brand

price for first to market

generic in US during

exclusivity1

‒ 47.8% of pre-entry brand

price for only on market

generic in US1

Significant pricing potential

1 Bureau of Economics, Federal Trade Commission, Working Paper No 317. The effect of generic drug competition on generic drug prices during the Hatch-Waxman 180-day exclusivity period. April 2013.

Device types

DPIpMDI

Direct

sales

force

Partner

sales

force

KOLs

Allergists Asthma

specialists

Primary care


Focus on pMDI market segment

Directly substitutable products

– No requirement for significant commercial

infrastructure

– Limited development

– Rapid route to market; near-term revenue

– Challenging to achieve for respiratory products

– Non-substitutable competitors require promotion

Novel combinations / products

− Longer more extensive development

− Majority of market in primary care

− Circassia to target allergy / asthma specialists

− Partner for phase III and targeting primary care

16

Novel technology provides sophisticated

API control

Directly substitutable products

‒ Potential first to market with

unique combination of therapeutic

equivalence, all strengths, similar

device, same formulation & cost-

effective

Novel products

‒ Optimized combinations and

novel formulations

Significant potential benefits

Technology #1

Technology #2

Established at commercial scale in cGMP compliant FDA-approved facilities

Broad IP protecting apparatus to 2022 in US & 2019 in EU; patents pending will

extend product and process protection to 2030 in US and 2028 in EU

Engineered API

‒ Size

‒ Shape

‒ Aerodynamics

‒ Surface properties

‒ Manufacturability

‒ Product stability

‒ Product performance

Technology controls

17

Lead product filed in EUCollaboration with Mylan

File in EU and retain marketing rights in certain

territories

Full rights retained in China, South America,

Middle East and Africa

Mylan has marketing rights in agreement territory1

FDA guidelines require PK and PD studies in US

Technology validation by leading company

1 USA, Canada, Australia and New Zealand, India, Japan, Europe (including the EU and EFTA states (Iceland, Liechtenstein, Norway and Switzerland)), Turkey, Russia and CIS

Originator sales estimate based on GSK Annual Reports 2011 and 2014 and selected IMS data 2011 and 2012

PSX1050

Flovent®

substitute (US)

Estimated $930m originator sales ($680m in US; $250m ex-US)

PSX1001

Flixotide®

substitute (EU)

Product candidate targeting substitution for

GSK’s Flixotide® pMDI (Flovent® pMDI in US)

Filing validated and under assessment Q3 2014

Review under EU orally inhaled products

guidelines that allow approval based on in vitro

equivalence data only

Decentralized procedure - MHRA reviewing file

Decision on first approval anticipated H2 2015

EU filing Mylan collaboration

18Strong pipeline of follow-up productsPSX2005

Seretide®

substitute

PX1439

Serevent®

substitute

1 Originator sales estimates based on GSK Annual Reports 2011 and 2014 and selected IMS data 2011 and 2012

Targeting UK filings by end H1 2016

Serevent® pMDI substitute

− Stability batches in place

− Estimated originator sales $60m1

− Partnered in UK / Ireland

Seretide® pMDI substitute

– Global rights retained

– Initial registration batches in place

– Originator sales estimated $1.8bn1

19Longer-term high value novel products

Significant efficacy vs placebo

PSX1002

Novel LAMA

formulation

1 Respiratory Market 2025: Taking A Deep Breath And A Deep Dive – Jefferies 2013 Equity Research

Optimized glycopyrronium bromide formulation

– Potential Spiriva® competitor targeting predicted >$3bn1 opportunity

– Compelling phase IIa results

20

Significant potential benefits for combination products

PSX3001

Novel triple

presentation

1 Inhaled corticosteroid (ICS) / long-acting beta agonist (LABA) / long-acting muscarinic antagonist (LAMA)


Triple combination ICS + LABA/LAMA1 targeting emerging ~$8bn2 market opportunity

Entered clinic H2 2015 - single-dose / repeat-dose 38-subject study

Results expected Q2 2016

2+1 formulation

LAMA LABA ICSLAMA ICSLABA

Engineered mono blend

21

Approach exploits market dynamicsOpportunity to capture modest share of significant markets

LABA/ICS PSX2005 targeting Seretide®

substitution

Monotherapy LAMA PSX1002

Triple fixed dose combination PSX3001


Monotherapy LABA PSX1439 targeting

Serevent® substituion

Global key inhaled maintenance respiratory market1 (excludes ICS monotherapy market: >US$2bn in 2014)

Monotherapy ICS PSX1001 / PSX 1050 targeting

Flixotide® / Flovent® substitution

Potential near-term approvals with high value follow up products

22

Marketed products



1

2

3

Summary

4

23

Allergic rhinitis is a global healthcare problemAffects 10-20% of global population

Allergic diseases affect over 1 billion people worldwide3

Allergic rhinitis is the world’s most prevalent chronic non-communicable disease3

Allergy is medical condition with greatest impact on work productivity in US4

Allergy is a precursor of asthma; treatment with immunotherapy halts “allergic march”

3 EAACI Global Atlas of Allergy 2014

4 Gemson & Eng, August 2004

1 US Census Bureau, 2012

2 World Bank, 2012

Immunotherapy is the only way to treat the underlying disease

Europe

Rank AllergenSkin prick test positive

(% Popln) (million)2

1 House dust mite 22 82

2 Grass pollen 17 63

3 Cat 8-10 30-37

4 Birch pollen 6 22

5 Mould 4 15

6 Olive pollen 3 11

Source: Bousquet et al. Allergy. 2007: 62: 301-9

USA

Rank AllergenSkin prick test positive

(% Popln) (million)1

1 House dust mite 28 86

2 Perennial rye 27 84

3 Short ragweed 26 82

4 Cockroach 26 82

5 Bermuda grass 18 57

6 Cat 17 53

Source: Arbes et al. J Allergy Clin Immunol. 2005 Aug;116(2):377-83.

Future potential targetsTargeted by Circassia

24

Moderate to severe allergy is inadequately addressed by current therapies

Allergen avoidance: not feasible in majority of cases

Symptomatic drugs: (anti-histamines, nasal corticosteroids etc) limited efficacy

– Prescription market estimated at approximately $7bn1

Whole allergen

immunotherapy

Targets cause of allergy

leading to tolerance of

allergens

Reduces “allergic march” to

asthma

Provided by allergy / asthma

specialists

Allergen under the tongue

Lengthy treatment 1 - 3yrs

Low adherence (7% complete 3yrs2)

US requires EpiPen prescription

High frequency of side effects

including potential for anaphylaxis

Subcutaneous

immunotherapy (SCIT)

Total 5 year cost: ~$3,600 – $6,000*

Sublingual

immunotherapy (SLIT)

Allergen injected

Lengthy treatment 3 - 5yrs

Poor patient adherence

Non-standardized dosing

High frequency of side effects

including potential for anaphylaxis

Total 1 year cost: $1,400 - $2,700**

Total 3 year cost: ~$9,000**

* Based on Circassia’s estimates

** Based on Merck/ALK and Stallergenes published US prices for SLIT treatments

1 Bloomberg

2 J Allergy Clin Immunol. 2013 Aug;132(2):353-60.e2. doi: 10.1016/j.jaci.2013.03.013. Epub 2013 May

3 Bousquet et al. J Allergy Clin Immunol. 2006 Jan;117(1):158–62

Majority of allergic rhinitis patients consulting a GP have moderate to severe symptoms3

25

Proprietary ToleroMune® technologyDesigned to treat underlying disease with minimal side-effects

T cell

epitopes

selected

Whole

allergen

Final product is a

room temperature

stable, lyophilized

vial containing a

mix of 7 peptides

for injection

Modern, synthetic, rationally-designed pharmaceuticals

ToleroMune® identifies T-cell epitopes

– Short linear stretches of amino acids in allergen sequence

– Binds to antigen presenting cells to induce regulatory T cells

– Identified from blood of allergic individuals

SPIREs – Synthetic Peptide Immuno-Regulatory Epitopes

Short treatment designed to provide efficacy without the safety issues

– Regulatory T cells down-regulate allergic response

– Lack of B-cell epitopes avoids cross-linking of mast cells eliminating

early response / no need to dose escalate

– Synthetic manufacture – no extraction from whole allergens

Broadly applicable across range of allergies

– Allergens already identified; no research required

26

Development stage Key findings

Birch SPIRE, Japanese cedar SPIRE and Alternaria SPIRE in earlier stage development

Cat SPIRE Phase III field study (n = 1,409)

House dust mite SPIRE Phase IIb study (n = 172)

Ragweed SPIRE Phase IIb study (n = 280)

Grass SPIRE Phase IIb study (n = 282)

Technology validated with clinical proof-of-concept in four programs

Proof-of-concept in multiple

products

Short-course treatment

Efficacy persists over time

Enhanced efficacy in more

symptomatic subjects

Safety profile similar to placebo

27

Cat SPIRE phase IIbProof-of-concept

Exposure

chamber

Toronto

Skin prick +ve cat:

US: 17%1 (53m)

EU: 8-10%2 (30-37m)

1 Arbes et al. J Allergy Clin Immunol. 2005 Aug;116(2):377-83

2 Bousquet et al. Allergy. 2007: 62: 301-9

Randomised, placebo-controlled parallel group chamber study

– Commercial-scale room-temperature stable formulation

202 subjects randomised

– 2 dosing regimens and placebo

Primary objective: evaluate efficacy in cat allergic subjects

following cat allergen challenge

Subjects in chamber 3 hours per day for 4 days at baseline and at

post-treatment challenge

– Controlled levels of cat dander (similar to house that has a cat)

– Symptoms recorded every 30 minutes

Comparison of symptom scores at challenge 5 months after

starting treatment to baseline

28

Overall TRSS improvement

of 2.1 vs. placebo (p = 0.05)

Total Rhinoconjunctivitis Symptoms Score (“TRSS”)

Patient self-rated scores used as primary efficacy

measure

Scoring system required by regulators

‒ Used for approval of intranasal steroids,

antihistamines etc

Scores measured on 4-point rating scale

‒ 0: absent

‒ 1: mild, barely noticeable

‒ 2: moderate, annoying / troublesome

‒ 3: severe, incapacitating

SPIRE studies use 8 symptoms = 24-point scale;

cat SPIRE used sneezing & runny / blocked / itchy

nose & itchy / watery / red / sore eyes

TRSS score of 8 could be 8 “mild / barely

noticeable scores”

TRSS score of 12 could be 4 “mild / barely

noticeable” and 4 “moderate / annoying” scores

Note: Based on non-asthmatic subjects

Cat SPIRE phase IIb (n=202)

Confirmed efficacy

29

Tolerance persists at least 2 years without further dosing

1 year follow-up study:

efficacy enhanced over time


of 3.9 vs. placebo (p = 0.01) Overall TRSS improvement


Secondary endpoint: TRSS

improvement at end of day 4:

5.1 vs. placebo (p=0.02)

Cat SPIRE phase IIbSustained benefit at 1 and 2 years with no additional dosing

2 years follow-up study:

efficacy persists at 2 years

Published: J Allergy Clin Immunol. 2013 Jan;131(1):103-9.e1-7 / Clin Exp Allergy. 2015 May;45(5):974-81. doi: 10.1111/cea.12488

30

Cat SPIRE represents therapeutic step changeMore effective and more convenient

Product / Study3 Treatment Difference Active vs.

Placebo TRSS

Cat SPIRE chamber study1 4 doses 4 weeks apart 3.9

ALK-Abelló Grazax® pivotal field study2

(licensed in Europe) SLIT tablets

Daily 16 weeks before and during

season1.0

Stallergenes Oralair® grass field study2 (licensed

in Europe) SLIT tablets

Daily 16 weeks before and during

season1.4

Allergy Therapeutics Pollinex® Quattro grass

field study2 (filed Germany in 2009, not yet

approved) adjuvanted whole allergen IT

4 administrations 1 week apart 1.1

GSK fluticasone furoate perennial rhinitis field

study2 intranasal steroidOnce daily for 4 weeks 0.86

Sanofi fexofenadine cat chamber study2

antihistamine

180 mg 2 hours before chamber

(ie pre-symptoms)1.3

1 Based on the 4 x 6 nmol dose of cat SPIRE in CP005A

2 Source: Summary of product characteristics for each product, except i) Fexofenadine: Ann Allergy Asthma Immunol. 2006 Feb;96(2):327-33 and ii) Pollinex Quattro: EAACI XXVIII Congress 2009 Poster presentation

3 TRSS scoring ranges from 16 – 24 points for these studies

31

Cat SPIRE phase III on track to report Q2 2016Multi-year follow up initiated

Screening Study Medication Administration (every 4 weeks ± 2days)

Visit 1A 1B/C 2A 2B 3A………………………………………….3H 3I

4A 4B 4C 4D 4E 4F 5

Period 3 (Post Administration Collection)

PAC1

x3 wks

PAC2

x3 wks

PAC3

x3 wks

Follow-Up

(3-10 days after PAC3)

Week -8 -3 0 20-22 28 30 37-39 52-54 Year 2 Year 3 Year 4 Year 5

Annual

Allergy

Evaluation*

Annual

Allergy

Evaluation*

Annual

Allergy

Evaluation*

Annual

Allergy

Evaluation*

* Timed to occur annually after Baseline Allergy Evaluation Period in CP007

Reporting of Health Economics (Subjects)

Quarterly Visits to confirm and evaluate Safety Information (Sites)

Period 1 Period 2

Baseline Allergy

Evaluation

x3 wks

End of Dosing

Assessment

(2 wks ± days since

last dose)

Randomisation

Cat SPIRE phase III: recruitment complete

2–5 year follow-up on track:

329 subjects enrolled*

1,409 cat-allergic subjects in North

America, EU and Russia

Baseline TRSS ≥10

Primary endpoint 1 year after start dosing

Single phase III & supporting studies

sufficient for registration

Pediatric safety study on track to

complete H2 2015

*At 28 July 2015

32

HDM SPIRE phase IIb (n=172)

Efficacy demonstrated at 1 year

Excellent data –

similar to cat SPIRE at 1 year

Overall TRSS improvement of 2.8

vs. placebo (p = 0.02) at one year


2 Bousquet et al. Allergy. 2007: 62: 301-9

Selected for oral presentation at AAAAI 2014

Increasing symptom severity

Treatment effect maintained in more

symptomatic subjects

Skin prick +ve HDM:

US: 28%1 (86m)

EU: 22%2 (82m)

33

HDM SPIRE phase IIb 2 year follow-up studyImprovement maintained; enhanced effect in more symptomatic

Overall TRSS improvement of 1.4 vs

placebo at two years

Overall TRSS improvement of

1.4 vs placebo at one year


3.0 vs. placebo

Matched subjects at year 1 and 2 Subjects with baseline TRSS >12

Symptom improvement sustained at same level in same patients

34

Grass SPIRE phase IIb (n=282)Efficacy demonstrated after first grass season

Increasing treatment effect over time


1.6 vs. placebo (p = 0.035)

Subjects with mean baseline TRSS ≥12


2.0 vs. placebo (p = 0.040)

Subjects with mean baseline TRSS ≥8

Enhanced efficacy in the more symptomatic

Skin prick +ve

grass:

US: 27%1 (84m)

EU: 17%2 (63m)

1 Arbes et al. J Allergy Clin Immunol. 2005 Aug;116(2):377-83 (Perennial rye)

2 Bousquet et al. Allergy. 2007: 62: 301-9 (Grass pollen)

35

Initial treatment effect maintained after three grass pollen seasons despite no further doses

Matched subjects (8 x 6 nmol group)

TRSS -2.9 vs.

placebo (p = 0.075)

Grass SPIRE phase IIb long-term follow-upSymptom improvement confirmed in same subjects

Matched subjects (4 x 12 nmol group)

TRSS -5.0 vs.

placebo (p = 0.004)

TRSS -3.4 vs.

placebo (p = 0.033)

TRSS -4.0 vs.

placebo (p = 0.016)

TRSS -4.5 vs.

placebo (p = 0.008)

TRSS -4.1 vs.

placebo (p = 0.010)

36

Ragweed SPIRE phase IIb (n=275)

Proof-of-concept demonstrated (2011)


1.7 vs. placebo (p = 0.066)


J. Allergy Clin. Immunol. 2012 Feb 129, Issue 2, Supplement , Page AB368

Stronger efficacy in more symptomatic subjects



Subjects with mean baseline TRSS ≥12Subjects with mean baseline TRSS ≥8

Skin prick +ve

ragweed:

US: 26%1 (82m)

37

Ragweed SPIRE phase IIbComparison treatment effect 2014 vs 2011 study

Greater placebo effect in 2014 study vs 2011 study on days 3 & 4

2011 (mean baseline TRSS ≥12) 2014 (mean baseline TRSS ≥12)


1.2 vs. placebo (p = 0.149)Overall TRSS improvement

2.9 vs. placebo (p = 0.044)

Mea

n c

han

ge in

TR

SS (

bas

elin

e m

inu

s fo

llow

-up

)

Marked placebo response

28 of 70 placebo-treated

subjects (40%) had >25%

reduction in symptom score

38

Mean Combined Score and mean ragweed

pollen count

Ragweed SPIRE phase IIb (2014)Field score endpoint

Mean change in Combined Score from pre-

season to peak season

Placebo 8 x 12 nmol

ITT population 68 69

Mean change in CS 0.79 0.53

p value vs placebo - 0.090

Field endpoint: combined TRSS (0-24 scale) and

rescue medication use (RMS) score (0-3 scale)

- Combined Score = (TRSS / 8) + (RMS); 0-6 scale

Treatment effect 33% vs placebo

- FDA requires at least 15% treatment effect1

- World Allergy Organization: at least 20% treatment

effect clinically meaningful

1 With upper bound of 95% confidence interval minimum10%

39

State-of-the-art synthetic production process

No natural whole allergen

No potency variation between vials

Patient-friendly administration

Standardized dose

No need for dose escalation

No need for doses tailored to individual patients

Very good safety and well-tolerated

Safety profile similar to placebo

No patients with anaphylaxis

Short course immunotherapy giving clearly superior efficacy

Efficacy for at least a year with single course

Two year follow-up data encouraging¹

Key characteristicsCurrent immunotherapy

Subcutaneous Sublingual

1 Demonstrated for cat SPIRE, HDM SPIRE and grass SPIRE

Potential to revolutionize immunotherapy market

Silicon crystals

40

Full global rights retainedIdeal fit with focused commercialization strategy

Commercialization strategy US cat SPIRE target population

Cat-allergic individuals

Offered IT

Accept IT

(~378k)

Consulting a specialist

Primary focus

Patients

declining IT

Secondary

focus

Patients not

offered IT

Complete

IT (~60k)

~24 million1

~1.3 million

~1.0 million

1 Kantar Health Quantitative Cat Allergy Report 2010

Independent in key markets

− Scalable infrastructure in place

− Train on cat SPIRE in preparation for launch

− Build relationships with allergists early

− Map out customers & key accounts in advance

− Current sales support field force build well ahead of launch

− Target steeper sales curve with higher peak

Sales force plan

– 100 in N America initially targeting 3,500 specialists

– 90 in EU targeting high prescribers among 6,600 specialists

Subsequently target other high prescribers

− Selected ENT physicians

− Special interest primary care physicians

Partner in other markets

Secondary

focus

Patients failing to

complete IT

41

US market research for cat SPIRE (Kantar / 2010)

− 93 allergists, 82 PCPs, 8 payers

− US opportunity: $0.5-1.0 billion peak annual sales

US pricing research for cat SPIRE (Bridgehead / 2011)

– 101 allergists, 105 patients, 35 payers

– Supports pricing of $2,000-3,000

EU market & pricing research for cat SPIRE (PRMA / 2011)

− 27 specialists, 28 PCPs, 27 payers

− Supports Grazax as the likely benchmark

US market overview for 4 lead SPIRE products (LEK / 2009)

– $2.6bn opportunity in US

US and European research for 4 lead SPIREs (GfK / 2014)

− $2,600 pricing in US

Consistent assessment of commercial opportunity

Selected sizing and pricing studies Opportunity for cat SPIRE

Illustrative peak sales of

c.$500-700mm for US and EU

US: 200,000 x $2,600 = $520mm

EU: 50,000 x $1,500 (€1,100) = $75mm

Equals 5 of 34 new cat

allergy patients / month

already coming to allergist

US pricing: Supported

by third-party research

1.5 million patients in

EU already on allergy

immunotherapy

EU pricing: Discount to

Grazax cost of €2.5-5.3k

over 3+ years

Multiple studies demonstrate significant

market opportunity

42

Marketed products



1

2

3

Summary

4

43

News Date* Description

Grass SPIRE support study H1‘15 Observational study (TG003) reports (n=102)

Grass SPIRE phase II results H1‘15 Phase II controlled asthmatic study (TG004) reports (n=54)

NIOX MINO® / NIOX VERO® sales data H2’15 Interim results with H1’15 sales results

Flixotide® substitute approval outcome1 H2’15 MHRA response to filing1

Cat SPIRE safety study complete H2‘15 Pilot pediatric safety study (CP009) completes (n≥12)

Ragweed SPIRE phase IIb complete H2’15 Phase IIb follow-up field study (TR006A) completes (n=249)

HDM SPIRE study recruitment H2’15 Complete phase IIb field study (TH005) recruitment (n=660)

Serevent® substitute filing H1’16 EU decentralized procedure filing to MHRA

Flixotide® substitute launch1 (if approved) H1’16 UK launch1 (if approved)

Seretide® substitute filing H1’16 EU decentralized procedure filing in UK

NIOX MINO® / NIOX VERO® sales data H1’16 Year end results with FY’15 sales

Cat SPIRE phase III results H1‘16 Phase III study (CATALYST) reports (n=1,409)

Grass SPIRE recruitment campaign H1‘16 Campaign starts for registration study

Triple combination study results H1’16 Repeat dose study reports (n=38)

NIOX MINO® / NIOX VERO® sales data H2’16 Interim results with H1’16 sales results

Cat SPIRE filing H2‘16 File for marketing approval

Birch SPIRE study results H2’16 Study reports following birch pollen season (n=64)

Strong newsflow

*To be included in announcements as appropriate and in-line with financial calendar including half-year / full-year results1Approval / launch reflects estimate of MHRA review timelines only

44Delivering on our strategy

Delivering the pipeline

– Flixotide® substitute approval anticipated H2 2015

– Two regulatory filings anticipated by end H1 2016

– On track to report cat SPIRE phase III in Q2 2016

– Strong clinical progress in multiple late-stage allergy programmes

Commercializing products independently in key markets

− Direct sales targeting allergy / asthma specialists in US and Germany

− Scalable infrastructure to optimize first allergy product launch

− Market access and payor expertise in place

− Leverageable across broader portfolio

Building broad and balanced portfolio

– Pipeline of 12 products in development for allergy, asthma and COPD

– Potential for 8 product launches by end 2021

World-class allergy & asthma specialty biopharma business fully funded to deliver portfolio

45A world-class specialty biopharma business

Strong pipeline

Marketed

products

Direct sales in US

and Germany

Broad international

distribution

network

Direct sales Distributors

Contact us

Office Investors Financial and Corporate

Communications

Circassia

Northbrook House

Robert Robinson Avenue

Oxford Science Park

Oxford OX4 4GA

United Kingdom

W: www.circassia.com

E: [email protected]

Steven Harris, CEO

Julien Cotta, CFO

T: +44 (0) 1865 405560

FTI Consulting

200 Aldersgate

Aldersgate Street

London EC1A 4HD

United Kingdom

T: +44 (0) 20 3727 1000

E: [email protected]

47

Financial highlightsFor the six months ended 30 June 2015 (unaudited)

Raised gross proceeds of £275m

− Acquisition of Prosonix completed on 15 June

− Acquisition of Aerocrine completed on 18 June (92.6% shares purchased; increased to 97.2% on 2 July)

− Consideration for Aerocrine £138.3m

− Consideration for Prosonix £100.0m (of which £30.0m contingent on lead product UK approval)

− Aerocrine loan £28.7m repaid to lenders (OrbiMed/Novo) on 29 June

− Deal costs £12.8m

Loss for the financial period £21.7m (H1 2014: £16.2m)

Cash at 30 June 2015 £238.9m (31 December 2014 £186.6m)

– Cash acquired with businesses £37.7m

– Contingent £30.0m payment expected by year end

– Fully funded to deliver pipeline

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Corporate Presentation November 2015 A world-class allergy ......2 Source: Summary of product...

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