Interim results for the six months ended 30 June 2019

Oxford, UK – 26 September 2019: Circassia Pharmaceuticals plc (“Circassia” or “the Company”) (LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces its unaudited interim results for the six months ended 30 June 2019 and a post-period update.

Highlights

40% revenue growth to £27.9 million in H1 2019 vs £19.9 million H2 2018
25% reduction in underlying continuing non-commercial costs to £7.6 million vs £10.1 million H2 2018
Growth drivers in place to achieve £60 million – £65 million full year 2019 revenues (2018: £48.3 million)
Dramatic reduction in net cash outflow post period end
Strong focus on cost control to continue transition to self-sustainability

Financial progress

*Key performance indicators (KPIs)**	H1 2019 underlying continuing operations	H2 2018 underlying continuing operations	H1 2019 total	H2 2018 total
Revenue	£27.9m	£19.9m	£27.9m	£19.9m
R&D¹	(£2.8m)	(£4.0m)	(£2.8m)	(£81.4m)
G&A¹	(£4.8m)	(£6.1m)	(£4.8m)	(£6.2m)
S&M¹	(£25.1m)	(£25.8m)	(£25.1m)	(£28.7m)
EBITDA	(£12.4m)	(£20.7m)	(£12.4m)	(£101.1m)
Cash² at period end	£21.0m	£40.7m	£21.0m	£40.7m

*KPI six-month comparison (H1 2019 vs H2 2018) reflects rapid and significant change following the establishment of dedicated sales forces in the US, Tudorza® option exercise on 31 December 2018 and transition to NIOX® direct sales in China

Post-period update and outlook

Cash balance of £19.8 million at 31 August 2019 (£21.0 million at 30 June 2019)
Net cash outflow expected to dramatically reduce during H2 2019 compared to H1 2019
Key revenue drivers in place (NIOX® direct sales in China; Duaklir® launch imminent; Tudorza® full control; LungFit PH³ (previously AirNOvent) launch planning)
Full year 2019 revenue expectation £60 million – £65 million
Focus on cost control to achieve positive EBITDA on approximately £75 million net annual sales
AstraZeneca five-year loan draw down to address outstanding transaction-related consideration

NIOX® progress

Sales increased 32% to £18.5 million (H1 2018 CER⁴: £14.0 million) and 40% compared with H2 2018 (CER £13.2 million)
Clinical (non-research⁵) revenues increased 38% compared with H1 2018 CER
US and China sales increased 10% and 193% respectively vs H1 2018 CER
Italy direct sales team launched September 2019

Tudorza® progress

Revenues £9.3 million (H1 2018 CER: £14.4 million following release of accrued rebates); revenues 43% higher than H2 2018 CER (£6.5 million)
Product licence transferred to Circassia at end of June 2019 providing additional commercial flexibility; distribution, pricing and market access strategies introduced to drive net revenue growth
Rebates significantly reduced in first two months of H2 2019 and revenues increased 61% to £5.0 million vs H1 2019 two-month average
Exacerbation reduction and cardiovascular safety data added to label

Duaklir® progress

NDA approved March 2019
Launch preparations complete; launch imminent

LungFit PH progress (previously AirNOvent)

FDA filing anticipated in Q4 2019

Steven Harris, Circassia’s Chief Executive, said: “Circassia made good financial and commercial progress in the first half of 2019, and we are delighted this has accelerated significantly in the past two months as our recent strategic changes begin to deliver results. During 2019, NIOX® revenues increased in all our direct markets, as well as those served by our partners, with particularly impressive growth in China following the launch of our new sales team. Since taking full control of Tudorza® in the United States at the end of June we have seen encouraging growth in net revenues, validating our newly-introduced commercial strategy.”

“As a result Circassia continues to make strong progress, dramatically reducing net cashflow outflow in the first two months of H2 2019, which we anticipate maintaining during the remainder of the year. With our ongoing focus on controlling our cost base and with multiple growth drivers in place, including the imminent launch of Duaklir® in the US and our new sales teams in China and Italy focused on growing NIOX® revenues, we look forward to further boosting our performance over the rest of the year. By building on our performance in the first two months of the second half, we plan to continue our drive towards profitability and our goal of building a self-sustaining specialty pharmaceutical business.”

Analyst meeting and webcast
An analyst meeting will take place today at 9.30am at finnCap, 60 New Broad Street, London, EC2M 1JJ. A webcast of the presentation will be available on the Company’s website.

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

Peel Hunt (Nominated Adviser and Joint Broker)
James Steel / Dr Christopher Golden Tel: +44 (0) 20 7418 8900

finnCap (Joint Broker)
Geoff Nash / Alice Lane Tel: +44 (0) 20 7220 0500

Numis Securities (Joint Broker)
James Black / Freddie Barnfield Tel: +44 (0) 20 7260 1000

FTI Consulting
Simon Conway / Ciara Martin Tel: +44 (0) 20 3727 1000

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, China, United Kingdom, Germany and Italy, and in a wide range of other countries through its network of partners. In the United States, Circassia has a 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 LungFit PH. For more information please visit www.circassia.com.

¹Excludes depreciation and amortisation
²Includes cash, cash equivalents and short-term deposits
³LungFit PH is not an approved name and may not be the final commercial name
⁴Constant exchange rates (CER) for H1 and H2 2018 represent reported numbers re‐stated using H1 2019 average exchange rates; management believes CER comparisons better represent underlying performance due to currency fluctuations against sterling
⁵Clinical revenues represent sales to clinicians, hospitals and distributors; research revenues represent sales to pharmaceutical companies for use in clinical studies

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.