IP : CircassiaPharma plc - General Meeting Business Update

Circassia Pharmaceuticals plc ('Circassia' or 'the Company'; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease announces that at the General Meeting of Shareholders being held at noon today which has been convened in connection with the Company's proposed move to AIM, its CEO, Steve Harris, will deliver the following statement to Shareholders in respect of the year ended 31 December 2018 and prospects for the year ahead.

Unaudited trading update

Circassia ended the year with cash, cash equivalents and short-term deposits of approximately £41 million. During 2018, the Company continued its robust focus on cost containment, and consequently net cash outflow for the year is expected to be under £20 million. Circassia expects revenue for the full year to be in the range £48 million - £52 million, following higher Tudorza® rebates in federal channels during the second half of 2018 and delayed recognition of revenue in China due to the establishment of the Company's new local subsidiary and supply chain.

Outlook

The Board's expectations for 2019 remain unchanged with significant opportunities for strong sales growth in the current financial year to December 2019 following exercise of the Tudorza option and establishment of the direct sales operation in China.

In December 2018, the Company announced that it had issued notice to exercise its option to acquire the full US commercial rights to Tudorza®, which completed as expected on 31 December 2018. The Company anticipates the product's licence to transfer to Circassia during 2019 following the FDA completing its review of the sNDA filing for the inclusion of additional data in the label, which is expected by 31 March. Transfer of Tudorza® to Circassia will allow the Company additional flexibility to manage the product's commercial and promotional priorities.

During the first half of 2019, Circassia also anticipates receiving the outcome of the filing for Duaklir® approval in the United States, which has a target date of 31 March, and to launch the product later in the year, assuming approval. In preparation, Circassia is launching dedicated COPD and NIOX® promotional teams to improve targeting and efficiency and prepare for Duaklir® launch. A deferred Tudorza® option payment of $20 million will be payable upon approval of Duaklir®, in addition to deferred consideration of $100 million due under the companies' agreement. The Company anticipates satisfying the option payments and deferred consideration via third-party funding, or through a loan facility provided by AstraZeneca under the companies' agreement if this is unavailable.

The Company also plans to roll out its significantly expanded sales force in China at the beginning of the year, where it intends to sell its NIOX® products direct in this large market, alongside existing distributors. As a result, in 2019 the Company anticipates continuing its rapid transformation into a commercially-focused specialty pharmaceutical business focused on respiratory.

Steve Harris, Circassia's CEO, said: 'Circassia continued to make progress during 2018, and with our cost containment efforts showing results and revenues growing we look forward to continuing our trajectory towards self-sustainability. We look forward to the coming year, as we roll out our expanded sales force in China and plan to take full control of Tudorza® and launch Duaklir®, once approved, in the United States.'

Contacts

Circassia	Tel: [phone]
Steve Harris, Chief Executive Officer Julien Cotta, Chief Financial Officer Rob Budge, Corporate Communications
Peel Hunt	Tel: [phone]
James Steel / Dr Christopher Golden
Numis Securities	Tel: [phone]
James Black / Freddie Barnfield
FTI Consulting	Tel: [phone]
Simon Conway / George Kendrick

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.