Interim Results for the Six Months Ended 30 June 2018
– NIOX® sales growth continued –
– Tudorza® profit share revenues increased –
– Duaklir® NDA and Tudorza® sNDA accepted for review by FDA –
– China commercial expansion on track –
– AstraZeneca equity stake increased –
Oxford, UK – 27 September 2018: Circassia Pharmaceuticals plc (“Circassia” or “the Company”) (LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces its interim results for the six months ended 30 June 2018 and a post-period update.
Financial progress
| Key performance indicators (KPIs) | H1 2018 KPI: underlying continuing operations | H1 2017 KPI: underlying continuing operations1 | H1 2018: total | H1 2017: total |
| Revenue | £28.4m | £18.3m | £28.4m | £18.3m |
| R&D | (£5.7m) | (£7.1m) | (£6.9m) | (£27.2m) |
| G&A | (£5.2m) | (£4.6m) | (£5.5m) | (£5.1m) |
| S&M | (£27.7m) | (£21.1m) | (£27.7m) | (£21.6m) |
| EBITDA | (£12.1m) | (£16.8m) | (£13.6m) | (£35.5m) |
| Net cash flow6 | (£8.7m) | (£23.4m) H2 2017 | (£8.7m) | (£34.5m) |
| Cash2 at period end | £50.8m at 30 June 2018 | £59.5m at 31 Dec 2017 | £50.8m | £82.9m |
NIOX® progress
- Sales increased 12% at CER3 to £14.0 million (H1 2017 CER: £12.5 million)
- Clinical sales (non-research sales4) increased 11% at CER vs H1 2017
- US clinical revenues grew 13% at CER compared with H1 2017
- Reimbursement increased to 80% of US covered lives
- NIOX VERO® upgrade in market testing
US COPD portfolio progress
- Tudorza® profit share revenues increased 4% at CER to £14.4 million vs H2 2017
- Tudorza® prescriptions continued to stabilise during H1 2018
- Duaklir®5 NDA accepted for review; PDUFA action date 31 March 2019
- Tudorza® sNDA under review for inclusion of unique clinical data in label
Commercial expansion progress
- China expansion on track; sales force launch anticipated by year end
- UK team expansion to exploit highly supportive NICE guidelines for FeNO testing in asthma
AstraZeneca agreement progress
- New shares issued to AstraZeneca increasing holding to 19.9%
- $26.7 million consideration for new shares paid to AstraZeneca as R&D contributions
- Vendor loan backstop extended to cover remaining $18.3 million R&D payments due by end 2019
- Commitment to FCA to seek shareholder approval to move to AIM if free float remains below 25%
Steve Harris, Circassia’s Chief Executive, said: “During 2018 we have accelerated our transition into a commercially-focused organisation as part of our strategy to build a high growth, profitable specialty pharmaceutical business. In the first six months of the year we have made good financial progress, increasing our revenues from both NIOX® and Tudorza®, delivering R&D cost savings and significantly reducing our net loss and cash outflow.”
“Building on this progress, we are further expanding our commercial capabilities and continuing to pursue additional products to commercialise through our platform. In the coming weeks we plan to launch our new sales team in China, and in the next six months we look forward to the FDA completing its review of the Duaklir® NDA and Tudorza® sNDA. With the team making encouraging progress right across Circassia, we are working hard to make 2018 a transformational year for the Company, as we lay the foundations to transition to profitability.”
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 will be available on the Company’s website at www.circassia.com.
Enquiries
Circassia
Steve Harris, Chief Executive Officer Tel: +44 (0) 1865 405 560
Julien Cotta, Chief Financial Officer
Rob Budge, Corporate Communications
Peel Hunt
James Steel / Christopher Golden Tel: +44 (0) 20 7418 8900
Numis Securities
James Black / Freddie Barnfield Tel: +44 (0) 20 7260 1000
FTI Consulting
Simon Conway / Mo Noonan Tel: +44 (0) 20 3727 1000
About Circassia
Circassia is a world-class specialty pharmaceutical business focused on respiratory disease. Circassia sells its novel, market-leading NIOX® asthma management products directly to specialists in the United States, United Kingdom and Germany, and in a wide range of other countries through its network of partners. In 2017, the Company established a commercial collaboration with AstraZeneca in the United States in which it promotes the chronic obstructive pulmonary disease (COPD) treatment Tudorza® and has the commercial rights to NDA-stage COPD product Duaklir®. For more information please visit www.circassia.com.
1Restated to show results of respiratory R&D in non-underlying operations
2Cash, cash equivalents and short-term deposits
3Constant exchange rates (CER) for H1 2017 represent reported numbers re‐stated using H1 2018 average exchange rates; management believes CER better represents underlying Group performance due to currency fluctuations against sterling
4Direct clinical sales to clinicians, hospitals and distributors; research sales to pharmaceutical companies for use in clinical studies
5Duaklir® is a registered trademark in Europe and other markets; use of the trademark in the US is subject to approval by the FDA
6Net cashflow includes movements in cash, cash equivalents and short-term deposits
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.