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Building a self-sustaining, world-class specialty pharma business
Corporate PresentationJune 2017
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.
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Two products marketed through specialty commercial infrastructure; >$200m peak sales potential
Market-leading asthma management product NIOX®
COPD treatment Tudorza® in US collaboration with AstraZeneca
Strong commercial platform
200-strong US field force
UK, Germany and China teams
US phase III COPD product Duaklir®
Study reports H2 2017
>$180m peak sales potential
Broad respiratory pipeline based on proprietary technology
Funded to deliver (£117.4m cash1 at 31 December 2016)
1 Cash, cash equivalents and short-term bank deposits
The Duaklir® trademark is registered in the United States; the mark is not currently approved for use by FDA
Circassia overview
Building a self-sustaining specialty pharma business
4
Respiratory novel
products
Expanding specialty commercial infrastructure
2
Robust growth strategyBusiness built on multiple pillars
M&A, in-licensing &
partnering
- exploit commercial
platform
- expand portfolio
Asthma management
products
1 4
Respiratory direct
substitutes
3
5
Global presence>400 people worldwide with ~70% in US
5
Oxford, UK
Global HQ, Global R&D,
UK Commercial OperationsResearch Triangle Park, NC
US Commercial
Operations & Distribution Uppsala, Sweden
Europe & RoW Distribution
Bad Homburg, Germany
Sales & Marketing
Beijing, China
Commercial Operations
Sales Channels
Direct
Representative Office
Distributor
6
Product Research Preclinical Phase I Phase II Phase III / Substitute Approved Marketed
NIOX VERO® / NIOX MINO®
Tudorza® US*
Duaklir® US
Flixotide® substitute**
Seretide® substitute
Flovent® substitute**
Spiriva® substitute
Novel LABA / LAMA formulation
Novel COPD therapy formulation
Strong portfolioApproved, nearer-term and earlier-stage products
*Commercial collaboration
**Partnered
New specialty COPD
products in development
Exciting new commercial
collaboration
New substitute product
targeting Spiriva®
7
NIOX® asthma management
AstraZeneca partnership
Respiratory pipeline
1
2
3
Summary
4
8
NIOX® is only point-of-care FeNO device available across all major markets
Clinical evidence shows FeNO monitoring improves asthma management
– Improves diagnosis
– Improves determination of inhaled steroid responsiveness
– Improves stepwise dosing of inhaled steroids
– Improves monitoring of asthma control and treatment adherence
– Potential to reduce exacerbations
Research sales for use in big pharma clinical studies
− Validates importance; trains physicians; raises profile in asthma community
− Revenues dependent on study numbers and timings
Leadership in FeNO asthma management
NIOX VERO®
Launched in major markets
Ages 4+ EU; 7+ in US
6 and 10 sec test; ~60 sec result
Monitor lasts 5 yrs / 15,000 tests
9FeNO-directed therapy reduces exacerbations
Syk et al. J Allergy Clin Immunol Pract. 2013;1(6):639-648.
FeNO group had reduced time to
first exacerbation
FeNO group had reduced number
of subjects with exacerbations
10
NIOX® installed base
Clinical devices and tests growingFoundations in place to boost NIOX® sales
Test sales (‘000s)
6,469 7,152
8,702
FY 2015: 2,878
FY 2016: 3,612
7,385
FY 2013: 1,816
FY 2014: 2,265
11
Strong commercial and R&D performancePositioned for growth
23% growth vs 2015; 35% increase in clinical sales
17 new key US accounts and 6 new health systems
(>2.8m lives) covering NIOX® Q1 2017
57% growth in US clinical sales Q1 2017 vs Q1 2016
Evolving US experience program for 2017
Adding UK / German customer evaluation programs
Adding new territories; launches in Italy and France
Commercial progress
Recent approval in Canada
Successful indication extension studies
− US pediatric study
− European primary ciliary dyskinesia diagnosis
510(k) filed in US
Nasal algorithm in preparation for CE marking
Prototype connectivity hub for cloud solutions
Next generation device concepts in development
R&D progress
12
Potential to predict response to biologicsIncreasingly important for payors
FeNO identifies likely (and unlikely)
responders to Xolair® (omalizumab)
- $10,000 - $30,000 per year treatment
for moderate-to-severe allergic asthma
CI = confidence interval
Mean percent reduction (95% CI) in protocol-defined asthma exacerbation rate in low- and high-biomarker subgroups (baseline fractional
exhaled nitric oxide [FeNO], peripheral blood eosinophils, and serum periostin)
*Exacerbation reduction P values; omalizumab versus placebo in each biomarker subgroup
Hanania et al. Am J Respir Crit Care Med. 2013;187:804-811
Asthma exacerbation reduction by biomarker
13
Summary
NIOX® asthma management
AstraZeneca partnership
Respiratory pipeline
1
2
3
4
14
Transformational products
Adds Tudorza® in US
Adds Duaklir® phase III (approved in EU) as market moves towards LAMA / LABAs
Products feature Pressair® potential best-in-class device
Transforms Circassia’s commercial profile
Doubles marketed products with potential to triple in two years
Funds significantly broader commercial infrastructure
Transitioning Circassia into world-class respiratory business positioned for further licensing and M&A
Attractive transaction structure
Total consideration $175m-$230m plus Duaklir® deferred royalties
$50m equity upfront with maximum $180m deferred consideration anticipate funded by debt (vendor loan back stop)
Commercial expansion and R&D contribution addressed by profit share collaboration
Transaction expected to deliver profits after one year
Transformational transaction with AstraZeneca
Commercial collaboration, option and sub-license of US product rights
15
Tudorza® Pressair®
LAMA – maintenance bronchodilator
for adults with COPD
$80m sales in US in 2016
Broad clinical database
– Three pivotal studies
– H2H vs Spiriva®
Aclidinium bromide (400µg twice daily)
Comparison vs market leading LAMA (tiotropium; Spiriva®)
*p<0.05 vs tiotropium
Both treatments statistically significantly higher than placebo at all time points
Beier et al COPD 2013
16
Duaklir® Pressair®
LAMA / LABA fixed dose combination
Approved in ~50 countries
including EU for adults with COPD
Broad clinical database
– Two pivotal studies
– Study vs Seretide®
Identical product in phase III
development for US market
Aclidinium / formoterol (400µg / 12µg twice daily)
The Duaklir® trademark is registered in the United States;
the mark is not currently approved for use by FDA*p<0.05****p<0.0001
Adapted from Singh et al BMC Pulm Med 2014; D’Urzo et al Respir Res 2014
FEV1 1hr post-morning dose FEV1 morning pre-dose (trough)
Study
1
Study
2
17
Pressair® inhaler offers significant advantagesPotential best in class mDPI used for both Tudorza® and Duaklir®
p<0.0001 vs comparator
Strong patient preference
Van der Palen et al. Expert Opin Drug Deliv 2013;
Chrystyn et al. ERS 2014; LAC39: data on file
Groups more likely to report COPD
Current / former smokers
Aged over 65
Women
History of asthma
More likely among COPD patients
Activity limitations
Unable to work
Require equipment such as
portable oxygen tanks
Increased hospital stays
Other chronic diseases
US COPD patient profile
18
GOLD COPD guidelines updated for 2017 Support LAMA and LAMA / LABAs as preferred treatments
LAMA + LABA LABA + ICS
LAMA
Further
exacerbation(s)
Group C Group D – most severeConsider roflumilast if
FEV1 < 50% pred. and
patient has chronic
bronchitis
Consider macrolide (in
former smokers)
LAMA + LABA
+ ICS
LAMA LAMA + LABA LABA + ICS
Further
exacerbation(s)
Further
exacerbation(s)
Persistent
symptoms / further
exacerbation(s)
Group A - least severe
Continue, stop or try
alternative class of
bronchodilator
A bronchodilator
evaluate effect
Group B
LAMA + LABA
A long-acting
bronchodilator
(LABA or LAMA)
Persistent
symptoms
From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017.
Available from: http://goldcopd.org.
Previously
SAMA or
SABA
Previously
ICS + LABA
or LAMA
Previously
ICS + LABA
and / or
LAMA
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COPD market offers major opportunityMarket moving to LAMA containing products
COPD is broad diagnosis including
emphysema and chronic bronchitis
Market projected to reach >$13Bn by 2022
Significant healthcare economic burden;
>$50Bn in US alone
3rd leading cause of death in US (2014)
2016 US LAMA-based market ~$2.3bn
Updated GOLD guidelines support
increased use of LAMA-based products
Tudorza® peak US sales potential >$90m
Duaklir® US peak sales potential >$180m
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Market # HCPs Annual Annual
Decile # HCPs % Reach Reached Calls/HCP Calls
10 129 50% 65 18 1,165
9 424 50% 212 18 3,816
8 1,191 50% 596 18 10,722
7 3,011 50% 1,505 12 18,064
6 5,717 0% - - -
5 9,148 0% - - -
4 13,724 0% - - -
3 21,029 0% - - -
2 36,690 0% - - -
1 167,111 0% - - -
TOTAL 258,174 1% 2,378 14 33,766
*Excludes prescribers reached in left table
Tudorza # HCPs Annual Annual
Decile # HCPs % Reach Reached Calls/HCP Calls
10 248 95% 236 36 8,482
9 525 95% 499 36 17,955
8 837 95% 795 36 28,625
7 1,242 95% 1,180 24 28,318
6 1,786 95% 1,697 18 30,541
5 2,538 95% 2,411 18 43,400
4 3,496 95% 3,321 12 39,854
3 4,788 95% 4,549 12 54,583
2 7,675 0% - - -
1 23,444 0% - - -
TOTAL 46,579 32% 14,687 17 251,758
Focused call plan reaches major prescribers
Expanded sales force to target top 8 Tudorza® prescriber deciles
~15k prescribers responsible for 80% of Tudorza® prescriptions
Complement with top 4 deciles of COPD prescribers (non-Tudorza®) in areas with positive payer coverage
Targeting top Tudorza® prescribers Targeting top COPD prescribers (non-Tudorza®)
Data sourced from IMS
HCP = healthcare professional
+
{Top
40%{Top
80%
21Rapid progress executing plan
Tudorza® #1 in sales call & higher frequency increases intensity
US sales force expansion by 100
− Over 3,500 applications
Strong support team
– Sales management; marketing; medical; training; analysis
Existing sales force trained on Tudorza®
AstraZeneca training, marketing materials and data
Circassia Tudorza® promotion began 8 May
First expansion wave training from 8 May with promotion 22 May
Expansion to 200 with full promotion 5 June (original target by end July)
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2017 commercial platformWell positioned for in-licensing, partnering and acquisition
US team significantly strengthened to deliver
200 fieldreps
6 medicalsupport
6 managed markets
4 marketing3 inside
sales
21 managers
7 key accounts
8 commercial operations
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Summary
NIOX® asthma management
AstraZeneca partnership
Respiratory pipeline
1
2
3
4
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Particle-engineered respiratory products Near-term pipeline & longer-term novel formulations
73.5% of pre-entry brand
price for first to market
generic in US during
exclusivity1
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
Directly substitutable products
– Limited development
– Abbreviated route to market; near-term revenue
– No requirement for significant promotion
– Challenging to achieve for respiratory products
Novel combinations / formulations
− Longer more extensive development
− Develop specialty products
Novel technology controls API properties
25
1 Partner rights: USA, Canada, Australia and New Zealand, India, Europe (including the EU and EFTA states (Iceland, Liechtenstein, Norway and Switzerland)), Turkey, Russia and CIS
Originator pMDI / DPI sales $866m (~60%US)
Partnered with Mylan1
Main market US
Product was approved in all three strengths in UK
Smaller EU market potential opportunity for Circassia
Discussions initiated for return of EU rights H2 2016
Plan to determine EU approach in coming months
Targeting GSK’s Flixotide® / Flovent® pMDI
Flixotide® & Seretide® pMDI substitutes
Global rights retained
Originator pMDI / DPI sales $4.7bn
Plan to reiterate pharmacokinetic study
UK filing anticipated H1 2019
Targeting GSK’s Seretide® pMDI
2626
Pharmacokinetic study planned for H1 2018
Spiriva® originator total revenues $3.3bn
Engineered substitute vs Spiriva® in vitro comparison
Deep lung
delivery
Non-
inhaled
portion
of dose
Two further product opportunities in
development
− Target underserved segment of
specialty COPD market
− LAMA / LABA targeting up to $700m
opportunity in US + EU5
− Exacerbation reduction therapy
targeting up to $250m opportunity
Three new COPD products added to pipelineIncluding Spiriva Handihaler® substitute
Additional specialty products
27
Summary
NIOX® asthma management
AstraZeneca partnership
Respiratory pipeline
1
2
3
4
28
News Date*
US sales force expansion complete H1’17
Duaklir® ACHIEVE study results H1’17
Interim financial results H2’17
NIOX VERO® US label extension approval H2’17
NIOX VERO® EU PCD launch H2’17
Tudorza® ASCENT study results H2’17
Duaklir® AMPLIFY phase III results H2’17
Spiriva Handihaler® substitute PK study initiation H1’18
NIOX VERO® asthma claim filing Japan H1’18
Novel LAMA / LABA formulation program study initiation H1’18
Preliminary full year financial results H1’18
Seretide® pMDI substitute PK study results H1’18
Duaklir® US filing H1’18
Strong newsflowPotential events to H1’18
*To be included in announcements as appropriate and in-line with financial calendar including half-year / full-year results
29
Two products marketed through specialty commercial infrastructure; >$200m peak sales potential
Market-leading asthma management product NIOX®
COPD treatment Tudorza® in US collaboration with AstraZeneca
Strong commercial platform
200-strong US field force
UK, Germany and China teams
US phase III COPD product Duaklir®
Study reports H2 2017
>$180m peak sales potential
Broad respiratory pipeline based on proprietary technology
Funded to deliver (£117.4m cash1 at 31 December 2016)
1 Cash, cash equivalents and short-term bank deposits
Building a world-class specialty
pharma company
Well positioned for further in-licensing, partnering and acquisition
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
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
