Preliminary Results for the Year Ended 31 December 2015

Click here to download the full 2015 preliminary results statement

– Positioned to deliver –
– Cat allergy phase III study on track to report Q2 2016 –
– Acquisitions validated; strong NIOX® sales growth and lead asthma product approved –
– Fully funded; successful £275 million fundraising completed June 2015 –

Oxford, UK – 11 March 2016: Circassia Pharmaceuticals plc (“Circassia” or “the Company”) (LSE: CIR), a specialty biopharmaceutical company focused on allergy and respiratory medicine, today announces its preliminary results for the year ended 31 December 2015.

Commenting on the results, Steve Harris, Circassia’s Chief Executive, said: “Circassia is in a period of exciting transformation as we accelerate our strategy to become a self-sustaining specialty biopharmaceutical company.  Our innovative allergy treatments continue to make good progress, and we remain on track to deliver our phase III results in the coming months.  During the year, we successfully completed two strategic acquisitions, which give us established specialty commercial infrastructure targeting the key customers for our next-generation allergy immunotherapies, while also significantly broadening our pipeline.  Importantly, these acquisitions have been validated by the significant sales growth of our acquired NIOX® products and the approval of our lead asthma treatment. 

In the coming year, we intend to build on this progress, expanding our commercial presence in preparation for the launch of our first allergy treatment, while further increasing sales of our approved products.  We also plan to deliver on our wider pipeline, including moving our grass allergy treatment into a registration study.  As a result, 2016 will be an important year for Circassia as we move towards our goal of building a leading specialty biopharmaceutical business.”

OPERATIONAL HIGHLIGHTS

Allergy clinical programmes progressing

  • Cat allergy phase III pivotal study (CATALYST) completed last patient dosing; results expected Q2 2016; pre-BLA meeting scheduled with FDA
  • Cat allergy two-to-five year follow-up (CP007A) continuing enrolment; 424 subjects enrolled to date
  • Cat allergy paediatric safety study (CP009) completed
  • Grass allergy registration study on track to start H1 2016
  • House dust mite allergy phase IIb field study (TH005) completed enrolment (n=715 subjects)
  • Ragweed allergy phase IIb follow-up (TR006A) completed; treatment effect demonstrated for all regimens with 21% improvement in change in combined score across season for highest dose
  • Ragweed allergy phase IIb dose-ranging study on track to begin recruitment in 2016 season
  • Birch allergy first-in-human clinical study fully recruited and dosing complete; data expected Q3 2016

Asthma management products achieved strong growth

  • NIOX® sales increased 32% to £10.3 million since acquisition (same period 2014 at CER: £7.8 million)1
  • NIOX VERO® launched in China in August
  • Study initiated to extend US indication to children aged four to six years old

Respiratory programmes advancing with lead product approved

  • Lead asthma product targeting substitution of GSK’s Flixotide® pMDI approved in UK under European Decentralised Procedure
  • Seretide® pMDI substitute targeting filing 2017
  • Triple combination first-in-human clinical study on track to report Q2 2016

Commercialisation on track with commercial organisation increased to over 100

  • Direct specialty sales established in US and Germany; broad distribution network in additional territories
  • Significant US sales team expansion; increased by 65% to 48 currently with further doubling planned by Q1 2017
  • Expansion of European direct sales presence into key European markets underway
  • Regional Medical Affairs team established in US and key European markets
  • Market access, supply chain, marketing and sales operations teams in place
  • New global NIOX® promotional campaign launched
  • Cat allergy market research completed; proposed brand and scientific names finalised

FINANCIAL HIGHLIGHTS

  • Placing and Open Offer successfully completed in June raising £275.0 million (gross) to fund strategic acquisitions
  • Robust revenue growth since acquisitions to £10.8 million (2014: £nil)
  • Research and development investment increased to £46.8 million (2014: £38.6 million)
  • Loss for the year £50.0 million (2014: £35.1 million)
  • Funded to deliver portfolio; £203.8 million cash2 at 31 December 2015 (31 December 2014: £186.6 million)
1 Acquisition completed 18 June; revenues recorded by Circassia 19 June – 31 December
2 Cash, cash equivalents and short-term deposits; £30 million paid to Prosonix ex-shareholders January 2016 following lead product approval


– Ends –

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 available in the Media section of the Company’s website at www.circassia.com.

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

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

Peel Hunt
James Steel / Tom Burt
Tel: +44 (0) 20 7418 8900

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

About Circassia
Circassia is a world-class specialty biopharmaceutical business focused on allergy and respiratory disease.  The Company has an established commercial infrastructure, marketed products, a pipeline of near-term therapies and a portfolio of next generation treatments targeting multi-billion dollar market opportunities.  Circassia sells its novel, market-leading products for asthma management directly to allergy / asthma specialists in the United States and Germany.  Its products are also promoted in a number of other countries by the Company’s international network of partners.

Circassia’s broad-based development pipeline includes a range of treatments for allergy and respiratory disease.  Circassia’s most advanced next-generation immunotherapy is currently in phase III testing for cat allergy, and is the first in a new class of treatments, Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs).  Three other SPIREs, targeting house dust mite, ragweed and grass allergies, have completed clinical proof-of-concept phase IIb studies.  Circassia’s lead asthma treatment, which targets substitution of GSK’s Flixotide® pMDI, is approved in the UK, and the Company is developing therapies targeting direct substitution of Seretide® pMDI and Serevent® pMDI.  The Company is also developing a number of novel treatments, including a fixed dose ‘triple’ combination containing an inhaled corticosteroid, long-acting beta agonist and long-acting muscarinic antagonist.  For more information on Circassia please visit www.circassia.com.

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.