IP : Circassia Pharmaceuticals Plc - Preliminary Results For The Year Ended 31 December 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 2018 and a post-period update.

Financial progress

Key performance indicators	2018 underlying continuing operations	2017 underlying continuing operations	2018 total	2017 total
Revenue	£48.3m	£46.3m	£48.3m	£46.3m
R&D	(£10.8m)	(£13.3m1)	(£89.4m)	(£103.0m)
G&A	(£11.4m)	(£10.7m1)	(£11.8m)	(£11.1m)
S&M	(£54.4m)	(£49.5m1)	(£57.3m)	(£50.1m)
Loss for the year	(£25.9m)	(£34.5m1)	(£117.1m)	(£99.1m)
Net Cash2 outflow	(£18.8m)	(£57.9m)	(£18.8m)	(£57.9m)
Cash2 at year end	£40.7m	£59.5m	£40.7m	£59.5m

NIOX® progress

• Sales increased 5% to £27.4 million (2017 CER³: £26.2 million)
• Clinical (non-research⁴) revenues increased 7% compared with 2017 CER
• China sales decreased 11% vs 2017 CER following destocking and disruption during transition to direct sales; new sales model now in place
• Q1 2019 unaudited revenues increased 38% vs Q1 2018 CER

US COPD portfolio progress

• Tudorza® profit share revenues increased 11% to £20.9 million (2017 CER: £18.8 million)
• Q1 2019 unaudited revenues increased 31% vs Q4 2018 CER following option exercise at year end; prescriptions stable
• Tudorza® option exercised acquiring product's full commercial rights
• Tudorza® ASCENT study data filed for inclusion in label; FDA approved March 2019
• Duaklir® NDA filed; FDA approved March 2019

Commercial platform progress

• China direct sales force launched; commercial team expansion to approximately 100 near completion
• UK team expanded; Commercial Director hired in Italy; European commercial operations strengthened
• US dedicated COPD and device teams launched to prepare for product launches

Corporate progress

• AstraZeneca subscription raising $26.7 million completed

Post-period highlights

• US and China commercialisation rights to novel nitric oxide product AirNOvent⁵ acquired January 2019
• Move to AIM completed February 2019
• AstraZeneca five-year loan addresses outstanding COPD transaction consideration, option and R&D payments

Steven Harris, Circassia's Chief Executive, said: 'We made good progress in 2018 completing our strategic transition into a commercially-focused specialty pharmaceutical business focused on respiratory disease. Our revenues continued to grow and we maintained our commercial investment and broad cost control activities. As a result, we dramatically reduced our net cash outflow and decreased the loss in our underlying business.

'During 2018, our global NIOX® business continued to grow, and following the launch of our direct sales team in China we look forward to expanding our presence in this significant market. We also advanced our US COPD portfolio, and in the first half of 2018 our partner filed for Duaklir® approval and an expanded label for Tudorza®. We are delighted that both filings were successful and we now look forward to enhancing our Tudorza® promotion and launching Duaklir® later this year.

'During 2019 we have maintained our momentum, taking full commercial control of Tudorza®, adding late-stage product AirNOvent to our portfolio, significantly increasing NIOX® revenues and boosting our commercial platform. As a result, we are making good progress building a robust business with growing revenue potential and an exciting commercial future.'

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 presentation will be available on the Company's website.

Contacts

Circassia	Tel: [phone]
Steven Harris, Chief Executive Officer Julien Cotta, Chief Financial Officer Rob Budge, Corporate Communications
Peel Hunt (Nominated Adviser and Joint Broker)	Tel: [phone]
James Steel / Dr Christopher Golden
Numis Securities (Joint Broker)	Tel: [phone]
James Black / Freddie Barnfield
FTI Consulting	Tel: [phone]
Simon Conway / Ciara Martin

About Circassia

Circassia is a world-class specialty pharmaceutical business focused on respiratory disease. The Company sells its novel, market-leading NIOX® asthma management products directly to specialists in the United States, United Kingdom, China and Germany, and in a wide range of other countries through its network of partners. In the United States, Circassia has a commercial collaboration with AstraZeneca in which it has the commercial rights to chronic obstructive pulmonary disease (COPD) treatments Tudorza® and Duaklir®. Circassia also has the US and Chinese commercial rights to the late-stage ventilator-compatible nitric oxide product AirNOvent. For more information please visit www.circassia.com.

¹Underlying operations restated to show the results of in-house respiratory development in discontinued operations

²Cash, cash equivalents and short-term deposits

³Constant exchange rates (CER) for 2017 represent reported numbers re‐stated using 2018 average exchange rates; management believes CER comparisons better represent underlying performance due to currency fluctuations against sterling

⁴Clinical revenues represent sales to clinicians, hospitals and distributors; research revenues represent sales to pharmaceutical companies for use in clinical studies

⁵AirNOvent is not an approved name and may not be the final name submitted for approval

To read the full RNS release, please click here.