Preliminary Results for the Year Ended 31 December 2017

Click here to download the full 2017 preliminary results statement

– Strong NIOX® sales growth –
– Good progress in AstraZeneca US commercial partnership –
– Compelling clinical data for Tudorza® and Duaklir® –
– Commercial platform expansion in US and China –
– Refocused investment strategy to support commercial expansion –

Oxford, UK – 24 April 2018: Circassia Pharmaceuticals plc (“Circassia” or “the Company”) (LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces its preliminary results for the year ended 31 December 2017 and a post-period update.

Strong NIOX® progress

  • Sales increased 18% (12% at CER1) to £27.3 million (2016 CER: £24.4 million)
  • Direct clinical sales (non-research sales2) increased 26% (20% at CER) compared with 2016
  • US clinical revenues grew 34% (27% at CER) vs 2016
  • China clinical sales increased 44% (36% at CER) vs 2016
  • New NICE guidelines issued in November highly supportive for FeNO testing in asthma diagnosis
  • NIOX VERO® product evolution and digital app in development; targeting 2019 launch in Europe

AstraZeneca (AZ) US commercial partnership progressing well

  • Transformational transaction for COPD products Tudorza® and Duaklir®3 completed April 2017
  • Tudorza® profit share revenues £19.0 million from transaction completion to year end
  • Tudorza® prescriptions stabilised; year ended 52% ahead of 2017 declining trend established prior to Circassia’s full promotion
  • Tudorza® ASCENT study met primary endpoints; compelling data to be filed for inclusion in label
  • Duaklir® AMPLIFY phase III study met primary endpoints; AZ to submit NDA H1 2018
  • AstraZeneca to increase equity stake in Circassia from 14.2% up to a maximum of 19.9%

Expanding commercial growth platform

  • US sales force expanded to 200 with approximately 50-strong support team
  • China commercial expansion; targeting NIOX® sales growth and platform for third-party products

Financial highlights

The following table includes key performance indicators (KPIs) representing the Group’s underlying operations at the time of operation; these include allergy R&D costs and exclude a one-off R&D contribution to AZ and R&D impairments.

2017 KPI* 2016 KPI* 2017 total 2016 total
Revenue £46.3m £23.1m £46.3m £23.1m
R&D expenditure £20.9m4 £45.9m4 £97.4m £17.8m
G&A expenditure £11.0m5 £14.6m6 £10.9m £14.9m
S&M expenditure £49.6m5 £27.0m6 £49.6m £27.2m
Group loss £36.9m5 £35.9m6 £99.1m £137.4m
Cash7 at period end

£59.5m at 31/12/17 £82.9m at 30/06/17 £59.5m £117.4m


2018 investment strategy refocused

  • Investment strategy increases focus on commercial expansion to drive revenue growth
  • Strategic plan to out-license / partner respiratory direct substitute and novel formulation candidates
  • R&D annualised expenditure to decrease by approximately £5 million
  • G&A cost containment to deliver annualised savings of approximately £2 million
  • S&M investment to increase approximately £7 million in 2018

Steve Harris, Circassia’s Chief Executive, said: “2017 was a period of major transformation for Circassia, with the Company making good progress to becoming a commercially-focused specialty respiratory business. During the year our market-leading NIOX® asthma management products continued their strong growth, and in November we welcomed new NICE recommendations that are highly supportive for our products.  We also established a major US collaboration with AstraZeneca for COPD products Tudorza® and Duaklir®, and markedly expanded our specialty sales infrastructure in the United States.  The partnership is making good progress, and with Tudorza® US prescriptions well ahead of the trend prior to our involvement, we aim to increase uptake in the coming year.  We also received compelling clinical data from large trials of both COPD products, and we look forward to filings seeking Duaklir® approval and an extension to Tudorza®’s label.”

“With our revenues doubling in 2017 and our cost containment measures delivering tangible savings, we are driving our business towards self-sustainability. We intend to maintain this progress during 2018.  We have refocused our investment strategy to support the ongoing expansion of our commercial platform, particularly in China, whilst reducing our R&D and corporate costs.  During 2018, we will benefit from a full year’s contribution from our enlarged US sales team and our collaboration with AstraZeneca, ‘locking in’ significant growth potential.  With a strong commercial infrastructure, compelling portfolio and increasingly attractive platform for third-party products we look forward to the coming year with great optimism.” 

Analyst meeting and webcast
An analyst meeting will take place today at 9.30am at FTI Consulting, 200 Aldersgate, Aldersgate Street, London, EC1A 4HD. A webcast of the event will be posted in the Media section of the Company’s website at www.circassia.com.

Enquiries

Circassia
Steve Harris, Chief Executive Officer                                                 Tel: +44 (0) 1865 405 560
Julien Cotta, Chief Financial Officer
Rob Budge, Corporate Communications

JP Morgan Cazenove
James Mitford / James Deal                                                              Tel: +44 (0) 20 7742 4000 

Numis Securities
Clare Terlouw / James Black                                                             Tel: +44 (0) 20 7260 1000 

FTI Consulting
Simon Conway / Mo Noonan                                                             Tel: +44 (0) 20 3727 1000

About Circassia
Circassia is a world-class specialty pharmaceutical business focused on respiratory disease. Circassia 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.  In 2017, the Company established a commercial collaboration with AstraZeneca in the United States in which it promotes the chronic obstructive pulmonary disease (COPD) treatment Tudorza®, and has the commercial rights to pre-NDA COPD product Duaklir®.  For more information please visit www.circassia.com.

*The Financial highlights section contains key performance indicators (KPIs) that management believes better represent the underlying performance of the Group, reflecting the functioning of the departments at the time of operation; where relevant these exclude irregular or infrequent items
1Constant exchange rates (CER) for 2016 represent reported 2016 numbers re‐stated using 2017 average exchange rates; management believes constant currency numbers better represent the underlying performance of the Group due to subsidiary functional currency fluctuations against Sterling
2Direct clinical sales to clinicians, hospitals and distributors; research sales to pharmaceutical companies for use in clinical studies
3Duaklir® is a registered trademark in Europe and other markets; use of the trademark in the US is subject to review and approval by the FDA
4In-house R&D: includes expenditure on underlying and discontinued operations excluding impairments to better reflect management expenditure at the time of operation
5Underlying operations, see consolidated statement of comprehensive income
6Underlying operations restated to show the results of the allergy business in discontinued operations; see note 10 of the consolidated financial statements for further details
7Cash, cash equivalents and short-term deposits

Forward-looking statements
This press release contains 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 that 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 press release 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.