Circassia Pharmaceuticals : Interim Results for the Six Months Ended 30 June 2017

Click here to download the full 2017 interim results statement

- Strong NIOX® sales growth -
- Duaklir® NDA filing on track following positive phase III results -
- AstraZeneca US commercial collaboration progressing well -
- Respiratory pipeline advancing -

Oxford, UK - 27 September 2017: Circassia Pharmaceuticals plc ('Circassia' or 'the Company') (LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces its interim results for the six months ended 30 June 2017 and a post-period update.

FINANCIAL HIGHLIGHTS

• Revenues increased 65% to £18.3 million (H1 2016: £11.1 million)
• R&D expenditure, including £14.6 million R&D contribution to AstraZeneca collaboration, increased to £27.2 million (H1 2016: £25.1 million)
• Loss for period reduced to £34.3 million (H1 2016: £101.8 million which includes £74.8 million of allergy-related impairments)
• Strong balance sheet with £82.9 million cash at 30 June 2017 (31 December 2016: £117.4 million)

OPERATIONAL HIGHLIGHTS

Strong NIOX® sales growth

• Sales increased 19% (8% at CER) to £13.1 million (H1 2016 CER: £12.1 million)
• Direct clinical sales increased 26% (15% CER) compared with H1 2016
• US clinical sales increased 39% (22% CER) vs H1 2016; reimbursement and key accounts expanded
• UK sales growth 100% vs H1 2016 following launch of direct sales team
• Global commercial team and commercialisation activities strengthened

AstraZeneca US commercial collaboration progressing well

• Duaklir®phase III study AMPLIFY met co-primary endpoints
• NDA planned H1 2018; supported by successful Duaklir® dose-ranging study ACHIEVE
• Encouraging stabilisation in Tudorza® US prescriptions
• US commercial team expansion completed ahead of schedule; 200-strong sales force launched 5 June

Respiratory portfolio advancing

• Seretide® pMDI substitute targeting initial filing H1 2019
• Spiriva® DPI substitute pharmacokinetic study on track to start H1 2018
• Smart nebuliser technology in-licensed from Philips
• Nebulised LABA / LAMA formulation on track to begin clinical study 2018
• Flixotide® pMDI substitute EU rights not returned; launch activities halted

Cost reductions implemented

• Allergy investment halted
• In-house R&D positions reduced by further 30%

Steve Harris, Circassia's Chief Executive, said: 'Circassia has made great progress so far in 2017, continuing NIOX®'s strong sales growth and culminating in the recent successful results from Duaklir®'s phase III AMPLIFY study, which pave the way for an NDA in the first half of next year. We are building impressive momentum in our US commercial collaboration with AstraZeneca, and as part of this flagship partnership we launched our significantly expanded US sales force in June, and Tudorza® prescription levels are responding positively. During the period we also continued to advance our broader respiratory pipeline. We recently licensed innovative 'smart' nebuliser technology from Philips, which we are incorporating into our novel LAMA / LABA formulation development programme, and our range of substitute products remain on track.'

'We intend to build on this success in the coming months. In particular, we plan to capitalise on our significantly expanded commercial capabilities to accelerate our NIOX® revenues and our AstraZeneca collaboration, while also pursuing additional opportunities to broaden our portfolio through in-licensing, acquisition and partnering. With a period of dramatic change behind us, Circassia has a strong commercial infrastructure, growing revenues, advancing pipeline and robust balance sheet. As a result, we are well placed to complete our transformation into a self-sustaining, world-class specialty pharmaceutical business.'

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 will be available 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 CazenoveJames Mitford / James Deal Tel: +44 (0) 20 7742 4000

Numis SecuritiesClare Terlouw / Freddie Barnfield Tel: +44 (0) 20 7260 1000

FTI ConsultingBen Atwell / 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. The Company recently established a collaboration with AstraZeneca in the US 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 development pipeline includes a range of respiratory medicines. The Company's lead asthma treatment targets substitution of GSK's Flixotide® pMDI and was approved in the UK. Circassia is also developing a direct substitute for Seretide® pMDI, and its 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.

Includes goodwill and other intangible assets impairment of £74.8 million associated with discontinued allergy programmes
Cash, cash equivalents and short-term deposits
Constant exchange rates (CER) for H1 2016 represent reported numbers re‐stated using H1 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
Direct clinical sales to clinicians, hospitals and distributors; research sales to pharmaceutical companies for use in clinical studies
Duaklir® is a registered trademark in Europe and other markets; the US trademark is subject to review and approval by the FDA

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.