4 Jan 2019 07:00
Circassia General Meeting Business Update
Oxford, UK - 4 January 2019: 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
Steve Harris, Chief Executive Officer Tel: +44 (0) 1865 405 560
Julien Cotta, Chief Financial Officer
Rob Budge, Corporate Communications
Peel Hunt
James Steel / Dr Christopher Golden Tel: +44 (0) 20 7418 8900
Numis Securities
James Black / Freddie Barnfield Tel: +44 (0) 20 7260 1000
FTI Consulting
Simon Conway / George Kendrick 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.
Notice to all Shareholders
The distribution of this announcement into a jurisdiction other than the United Kingdom may be restricted by law and, accordingly, persons into whose possession this announcement comes should inform themselves about and observe any such restrictions. Any failure to comply with any such restrictions may constitute a violation of the securities laws of the jurisdiction concerned. In particular, subject to certain exceptions, this announcement should not be distributed, forwarded or transmitted in or into the United States.
This announcement does not constitute an offer or invitation to the public to subscribe for or purchase securities but is being issued for the purposes of the Shareholders approving the Resolution.
Notice to Overseas Shareholders
The distribution of this announcement into jurisdictions other than the United Kingdom may be restricted by law. Persons into whose possession this announcement comes should inform themselves about and observe any such restrictions. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction.
Subject to certain very limited exceptions, this announcement will not be distributed in or into the United States, and this announcement does not constitute a public offer of securities under the applicable securities laws of any jurisdiction.
The Company's Ordinary Shares have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), or under any securities laws of any state or other jurisdiction of the United States. The Company's Ordinary Shares may not be offered, sold, resold, transferred or delivered, directly or indirectly, within the United States, except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with any applicable securities laws of any state or other jurisdiction of the United States. There will be no public offer of the Company's Ordinary Shares in the United States and this announcement does not constitute or form part of any offer to sell or issue or the solicitation of an offer to buy or subscribe for the Company's Ordinary Shares in the United States.
The Company's Ordinary Shares have not been approved or disapproved by the U.S. Securities and Exchange Commission, any state securities commission in the United States or any other U.S. regulatory authority, nor have any of the foregoing authorities passed upon or endorsed the merits of the Transaction or the Company's Ordinary Shares or the accuracy or adequacy of this announcement. Any representation to the contrary is a criminal offence in the United States.
Forward-looking statements
The statements contained in this announcement that are not historical facts are "forward-looking" statements. These forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's control and all of which are based on the Company's current beliefs and expectations about future events. Forward-looking statements are typically identified by the use of forward-looking terminology such as "believes", "expects", "may", "will", "could", "should", "intends", "estimates", "plans", "assumes" or "anticipates" or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. In addition, from time to time, the Company or its representatives have made or may make forward-looking statements orally or in writing. Furthermore, such forward-looking statements may be included in, but are not limited to, press releases or oral statements made by or with the approval of an authorised executive officer of the Company.
These forward-looking statements, and other statements contained in this announcement regarding matters that are not historical facts, involve predictions. No assurance can be given that such future results will be achieved; actual events or results may differ materially as a result of risks and uncertainties facing the Company and its subsidiaries. Such risks and uncertainties could cause actual results to vary materially from the future results indicated, expressed or implied in such forward-looking statements. The forward-looking statements contained in this announcement speak only as of the date of this announcement. The Company does not undertake any obligation publicly to update or revise any forward-looking statement as a result of new information, future events or other information, although such forward-looking statements will be publicly updated if required by the Listing Rules, the Prospectus Rules, the Disclosure Guidance and Transparency Rules, the rules of the London Stock Exchange or by law (as applicable).
General
Peel Hunt LLP ("Peel Hunt") is authorised and regulated by the FCA in the United Kingdom and is acting exclusively for the Company and no-one else in connection with the Transaction. Peel Hunt will not regard any other person as its client in relation to the Transaction and will not be responsible to anyone other than the Company for providing the regulatory protections afforded to its clients, nor for providing advice in relation to the contents of this announcement or any transaction, arrangement or other matter referred to herein.
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