Circassia Release: Interim Results For The Six Months Ended 30 June 2015

- 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)

1Acquisition of Aerocrine completed on 18 June; revenues recorded by Circassia from 19 - 30 June 2015
2Cash, 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

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