Circassia Pharmaceuticals plc Annual report and accounts for the year ended 31 December 2016

120 Pages·2017·3.34 MB·English

Determined
to deliver
Circassia Pharmaceuticals plc
Annual report and accounts 2016
Circassia in brief
Circassia is a world-class specialty respiratory pharmaceutical
business with a strong commercial infrastructure, marketed products
and portfolio of treatments targeting major market opportunities. The
Company sells its novel, market-leading NIOX® asthma management
products directly to specialists in the United States, United Kingdom
and Germany, and in a wide range of other countries through its
network of partners. Circassia recently established a collaboration
with AstraZeneca in the United States in which it promotes the chronic
obstructive pulmonary disease (COPD) treatment Tudorza®, and has
the US commercial rights to late-stage COPD product Duaklir®.
Circassia’s broad-based development pipeline includes a range of
respiratory medicines. The Company's lead asthma treatment, Fliveo®,
targets substitution of GSK's Flixotide® pMDI and is approved in the
UK. Circassia is also developing a direct substitute for Seretide® pMDI,
Seriveo®. In addition, the Company's pipeline includes a number
of inhaled medicines for COPD, including single and combination
dose products. For more information on Circassia please visit
www.circassia.com.
Contents
Strategic report
02 Investment proposition
10 Delivering a broad and balanced portfolio
12 Chairman’s statement
14 Operational and financial highlights
16 Chief Executive’s review
18 Business model
20 Strategy and progress against objectives We’re building a strong
22 Strategic review
29 Financial review portfolio of marketed products
33 Corporate social responsibility
36 Risks and risk management See page 02
Corporate governance
42 Board of Directors
44 Corporate governance
55 Remuneration committee report
76 Directors’ report
78 Statement of Directors’ responsibilities
79 Independent Auditors’ report
Group financial statements
84 Consolidated statement of comprehensive income
85 Consolidated statement of financial position
86 Parent Company statement of financial position We’re strengthening
87 Consolidated and parent Company statement of cash flows
our development pipeline
88 Consolidated statement of changes in equity
89 Parent Company statement of changes in equity
90 Notes to the financial statements See page 04
115 Glossary
116 Advisors and contact details
We’re focusing on our
customers
See page 06
We’re expanding our global
presence
See page 08
Circassia Pharmaceuticals plc Annual report and accounts 2016 01
We’re building
a strong portfolio
of marketed products
Specialty products focused on asthma
and chronic obstructive pulmonary disease
2
marketed products with more close behind
NIOX® for FeNO Tudorza® for chronic
obstructive pulmonary disease
Clinical evidence shows monitoring FeNO
helps improve asthma management
In our newly established US collaboration with
— Improves diagnosis by uncovering
AstraZeneca we will commercialise Tudorza®
airway inflammation
— Improves lung function (FEV) in COPD
1
— Improves determination of inhaled
— Features novel patient-friendly and
steroid responsiveness
easy-to-use inhaler
— Improves stepwise dosing of inhaled
— Improves night-time lung function on
steroids
day one vs market leader
— Improves monitoring of asthma control
— With placebo-like anticholinergic side-effects
and treatment adherence
typically associated with product class
— With potential to reduce exacerbations
Circassia Pharmaceuticals plc Annual report and accounts 2016 02
Over 50% $80 million
Our NIOX® revenues are growing strongly. During 2016 our collaboration partner
We increased our worldwide sales during AstraZeneca achieved $80 million
2016, and plan to continue growing our of revenues related to Tudorza® US sales.
revenues in the coming year. So far we are With a focused commercialisation plan
making good progress. During the first quarter in place, we plan to maintain and potentially
of 2017 our US clinical sales are up over 50%, enhance this performance as we rapidly
following the expansion of our sales force expand our commercial presence
in 2016. in this major market.
Circassia Pharmaceuticals plc Annual report and accounts 2016 03
We’re strengthening
our development pipeline
Balanced and broad portfolio with near,
medium- and longer-term products
6
respiratory medicines in development
for asthma and chronic obstructive
pulmonary disease
Duaklir® Direct substitutes Novel formulations
Duaklir® is currently in phase III development Our lead asthma medicine, Fliveo®, is already Our novel formulations for COPD are based
for chronic obstructive pulmonary disease approved in the UK, and targets direct on approved drugs. These formulations target
(COPD) in the United States. Our partner substitution of GSK’s Flixotide® pMDI. We are underserved segments of the specialist
AstraZeneca plans to submit an NDA to the working with our partner Mylan to develop moderate-to-severe COPD market, and we
US regulatory authorities in the first half of a similar product for the United States. In have completed initial technical assessments
2018 and we hope to launch the product parallel, we are working on direct substitutes for both.
the following year. for GSK’s Seretide® / Advair® pMDI and
Boehringer Ingelheim’s Spiriva Handihaler®.
Circassia Pharmaceuticals plc Annual report and accounts 2016 04
$24 billion 3rd GOLD
The respiratory market represents a $24 billion Approximately 15.7 million adults in the The 2017 Global Initiative for Chronic
opportunity. It is predicted to undergo United States have been diagnosed Obstructive Lung Disease (GOLD) guidelines
significant change, with current products with COPD and several million more are now include long-acting muscarinic
facing generic competition and new entrants estimated to be undiagnosed. The disease is antagonist containing products (LAMAs), such
taking an increasing market share, and the responsible for over 120,000 deaths per year as our Duaklir® and Tudorza®, as preferred
overall value growing modestly. We have the in the US making it the country’s third leading initial treatments for every group of COPD
opportunity to exploit these dynamics with our cause of mortality. patient. This is a marked move from previous
direct substitutes in the near-term and novel recommendations, supporting a shift to
formulations in the longer-term. LAMA-based products.
Circassia Pharmaceuticals plc Annual report and accounts 2016 05
We’re focusing
on our customers
Expanding commercial presence targeting
key customers in major markets
1 00%
larger commercial team focused on our
customers since H1 2016
NIOX® experience Tudorza® continuity
Our teams help customers experience NIOX® As we begin the US promotion of Tudorza®
in their clinical practise through a number of we are working hard to ensure continuity of the
evaluation initiatives. Our US team pioneered product’s brand. As a result we will use existing
a formal experience programme, and our UK AstraZeneca marketing materials, training and
and German organisations are maintaining data to maintain momentum. Our approach
momentum, adopting local versions. is designed to drive promotional efficacy,
as well as preserving brand recognition.
Circassia Pharmaceuticals plc Annual report and accounts 2016 06
250,000 200 80%
Asthma affects over 3% of the world’s In 2016 we doubled the size of our US Tudorza® prescribers who account for 80%
population. Despite treatment improving sales force to approximately 100. Under our of the product’s prescriptions in the US will be
considerably since the regular use of commercial collaboration with AstraZeneca the key focus of our sales force. We also plan
anti-inflammatory medicines 20 years ago, we intend to double the team again, and by to target the physicians who account for 40%
approximately 250,000 people die annually the end of July will have 200 representatives of non-Tudorza® COPD prescriptions in the
as a result of uncontrolled asthma. We are in the field promoting Tudorza® and NIOX®. US, while also focusing a proportion of our
targeting specialists around the world to help expanded efforts on NIOX® promotion.
improve asthma outcomes.
Circassia Pharmaceuticals plc Annual report and accounts 2016 07
We’re expanding
our global presence
Specialty commercial presence in the
United States, UK, Germany and China
40
countries where we sell, or our partners
distribute, our NIOX® products
Speciality sales Distribution network
Our sales teams target specialist and key We have a broad network of partners to
primary care physicians in major markets. distribute our NIOX® products in countries
During 2016, we doubled our US sales force, where we have no direct sales team.
strengthened our German team and launched These currently total approximately 35,
our direct presence in the UK. In parallel, we and we are adding new specialist distributors
expanded our team in China who support our in France and Italy to strengthen our European
local distributors. presence.
Circassia Pharmaceuticals plc Annual report and accounts 2016 08