Interim Results for the Six Months Ended 30 June 2015

Click here to download the full 2015 interim results statement

– Clinical programs on track –
– Cat allergy phase III to report H1 2016; recruitment for grass allergy phase III to start H1 2016 –
– Acquisitions accelerate commercialization strategy and broaden portfolio –
– Successful £275 million fundraising ensures fully funded to deliver pipeline –

Oxford, UK – 28 July 2015: Circassia Pharmaceuticals plc (“Circassia” or “the Company”) (LSE: CIR), a specialty biopharmaceutical company focused on allergy and asthma, today announces its interim results for the six months ended 30 June 2015.

OPERATIONAL HIGHLIGHTS

Allergy immunotherapy clinical programs on track
• Cat allergy phase III registration study (CATALYST) on track to report results H1 2016
• Cat allergy two-to-five year follow-up (CP007A) ongoing; 329 subjects enrolled to date
• Cat allergy pediatric safety study (CP009) on track to complete H2 2015
• House dust mite allergy phase IIb field study (TH005) targeting recruitment completion H2 2015; 334 subjects enrolled to date (target n=660)
• Grass allergy recruitment campaign for phase III on track to start H1 2016
• Grass allergy safety study (TG004) positive results enable inclusion of controlled asthmatics in phase III
• Grass allergy observational study (TG003) results informing phase III design
• Ragweed allergy phase IIb follow-up (TR006A) on track to complete H2 2015; 249 subjects enrolled
• Ragweed allergy recruitment campaign for phase IIb dose-ranging study on track to start in 2016 season
• Birch allergy first-in-human clinical study initiated

First allergy product launch preparations underway
• Regional Medical Affairs Directors appointed in US and EU to work with allergy experts
• Analytics, marketing and distribution management established in US
• Cat allergy product preferred brand names submitted to EU regulators for review
• Market research completed to inform launch positioning

Aerocrine acquisition accelerates commercialization strategy
• Brings novel market-leading NIOX® products for asthma diagnosis & management; strong growth potential with 28% sales increase in first six months (H1 2015 £ 9.1 million; H1 2014 £ 7.1 million)1
• Direct sales in US and Germany targeting allergy / asthma specialists
• Infrastructure highly complementary with Circassia’s commercial team
• Opportunity to expand EU presence and US organization
• Infrastructure scalable well in advance of first allergy launch to target steeper and higher sales curve
• Broad international distribution network covers additional territories

Prosonix acquisition broadens portfolio
• Brings near-term pipeline targeting direct substitution of leading asthma therapies, and high-value novel product candidates that fit focused commercialization strategy
• Lead product targeting substitution of GSK’s Flixotide® pMDI filed H2 2014; UK approval anticipated H2 2015
• Two further product filings planned by end H1 2016
• Novel ‘triple’ fixed combination therapy to enter clinic H2 2015
• Potential for eight product launches by 2021 (including four lead allergy products)

FINANCIAL HIGHLIGHTS

• Successful placing and open offer raised £275.0 million (gross) to fund acquisitions
• Research and development investment increased to £18.4 million (H1 2014: £16.4 million)
• Loss for the period increased to £21.7 million (H1 2014: £16.2 million)
• Fully funded to deliver portfolio; £238.9 million cash2 at 30 June 2015 (30 December 2014: £186.6 million)

1 Acquisition of Aerocrine completed on 18 June; revenues recorded by Circassia from 19 – 30 June 2015
2 Cash, cash equivalents and short-term deposits

Steve Harris, Circassia’s Chief Executive, said: “Following Circassia’s successful IPO in March 2014, the first half of 2015 has proved equally transformational for the Company.  We have continued to deliver our pipeline of next generation allergy immunotherapies, and our late-stage programs and phase III studies are on track.  At the same time, we have significantly accelerated our strategy to independently commercialize our products and build a broad and balanced portfolio, through the acquisitions of Aerocrine and Prosonix.  We now have an established commercial infrastructure selling novel products directly to allergy / asthma specialists in the US and Germany, who are the core customers for our allergy treatments.  In addition, we have complemented our late-stage allergy pipeline with a number of near-term asthma products and high value novel candidates.  In the coming year, we intend to expand our commercial presence in preparation for the launch of our cat allergy treatment, which we also expect to boost sales of our current asthma products.  As a result, we are ideally positioned to achieve our ambition of becoming a self-sustaining specialty biopharmaceutical 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 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 / Alex Bruce
Tel: +44 (0) 20 7742 4000

Peel Hunt
James Steel / Clare Terlouw
Tel: +44 (0) 20 7418 8900

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

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.

Notes to editors

Circassia
Circassia is a world-class specialty biopharmaceutical business focused on allergy and asthma.  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 market opportunities.  Circassia sells its novel, market-leading products for asthma diagnosis and 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 asthma.  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 product targets substitution of GSK’s Flixotide® pMDI, and was filed for regulatory approval in H2 2014.  The Company anticipates two further product filings by the end of H1 2016, targeting direct substitution of Serevent® pMDI and Seretide® pMDI.  Circassia 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 further information on Circassia please visit www.circassia.com.