Proposed Collaboration and Securing of Certain U.S. Commercial Rights to Tudorza® and Duaklir® from AstraZeneca

17 March 2017

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN, INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF THAT JURISDICTION 

This announcement is not an advertisement and not an offer of securities for sale in any jurisdiction, including in the United States, Canada, Australia, Japan and South Africa. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended (the “Securities Act“). Circassia Pharmaceuticals plc does not intend to register any of the securities in the United States or to conduct a public offering of the securities in the United States. 

Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. Any decision in respect of the Transaction should be made solely on the basis of the information that is contained in the combined prospectus and circular to be published by the Company in due course in connection with the Transaction.

Circassia Pharmaceuticals plc

 Proposed Collaboration and Securing of Certain U.S. Commercial Rights to Tudorza® and Duaklir® from AstraZeneca for Consideration of up to US$230 Million (including US$50 Million in Ordinary Shares (the “Consideration Shares”) on Completion) plus future royalties based on Duaklir® sales (the “Transaction”)

HIGHLIGHTS

• Circassia Pharmaceuticals plc (“Circassia” or the “Company”), a specialty pharmaceutical company focused on respiratory disease and allergy, has reached agreement with AstraZeneca to enter into a collaboration and secure certain U.S. commercial rights to two chronic obstructive pulmonary disease products, Tudorza® and Duaklir®*, for a maximum total consideration of US$230 million, plus future sales based royalties upon the commercialisation of Duaklir® in the United States, following potential approval.

• The Transaction provides an opportunity to transform Circassia’s product portfolio and commercial presence.

• The Products represent a clear strategic fit with Circassia’s focus on respiratory medicines and will leverage and enhance Circassia’s commercial infrastructure.
  

• Tudorza® is approved in the United States and approximately 60 further countries around the world; total AstraZeneca revenues related to worldwide sales of the product were US$170 million in 2016, of which US$80 million was in the United States.

• Duaklir® is in phase III development in the United States for the treatment of COPD; it was initially approved in the European Union in 2014 and is approved in approximately 50 countries worldwide.

• The Transaction will support the immediate expansion of the Company’s commercial infrastructure in the United States, positioning Circassia for future product acquisition and in-licensing opportunities.

• The consideration will be structured as follows:
  • Circassia will issue Ordinary Shares with a value of US$50 million to AstraZeneca on completion of the Transaction;
  • Circassia will pay AstraZeneca deferred non-contingent consideration of US$100 million on the earlier of: (i) 30 June 2019; and (ii) the approval of Duaklir® by the FDA;
  • Circassia will initially enter a commercial collaboration and profit share arrangement with AstraZeneca for Tudorza® in the United States. Based on the sales performance of Tudorza® in a twelve month period ending no earlier than 30 September 2018, or if Duaklir® gains FDA approval before 31 December 2019, Circassia will have the option to secure the remaining commercial rights and economic benefits of Tudorza® in the inhaled administration for all respiratory indications (the “Field”) in the United States (the “Tudorza® Option”). If the Tudorza® Option is taken, Circassia will make further payments to AstraZeneca of up to US$80 million dependent on the level of Tudorza®’s sales within the United States;
  • Circassia intends to fund the deferred and contingent consideration through third-party financing;
  • Circassia will pay royalties to AstraZeneca on sales of Duaklir® in the United States, following potential approval; and
  • Circassia will make R&D contributions of up to US$62.5 million payable to AstraZeneca as deferred payments, which the Company intends to fund through its returns from the commercial collaboration and profit share with AstraZeneca.

• The Transaction structure allows Circassia to accrue the benefits of a broader product portfolio as well as significant infrastructure expansion with no funding requirement anticipated from Circassia shareholders.

• The Transaction is anticipated to be earnings enhancing for Circassia after one year and broadly cash neutral for three years, then cash generative.

Due to its size, the Transaction constitutes a Class 1 transaction for the Company under the Listing Rules and is therefore subject to the approval of Shareholders. A combined prospectus and circular containing further details of the proposed Transaction and containing the notice convening a general meeting to consider a resolution to approve the Transaction will be sent to Shareholders as soon as practicable. This summary should be read in conjunction with the full text of this announcement.

Steve Harris, Chief Executive of Circassia, said:
“This proposed transaction is an ideal fit with Circassia’s strategy and respiratory focus. It represents a transformational opportunity for the Company, doubling the number of marketed products in our portfolio, with the potential to triple the current number within two years.  Through an initial commercial collaboration with AstraZeneca, we plan to double our U.S. sales force to promote Tudorza® as our priority, as well as our existing NIOX® products, transforming Circassia into a world-class respiratory business positioned for future in-licensing and M&A.  In addition, the transaction structure is highly attractive, allowing us to fund the consideration without further investment anticipated from shareholders, while at the same time welcoming AstraZeneca to our share register.”

Mark Mallon, Executive Vice President, Global Product & Portfolio Strategy at AstraZeneca, said:
“Tudorza and Duaklir are important components of AstraZeneca’s respiratory franchise globally and this collaboration will support their commercialisation in the US for the benefit of the millions of COPD patients. It also further sharpens our focus on Symbicort, Bevespi Aerosphere, benralizumab and other respiratory development programmes. Circassia will be an important strategic partner for AstraZeneca in the US and we look forward to working closely together.”

This announcement is released by Circassia Pharmaceuticals plc and contains inside information for the purpose of Article 7 of the Market Abuse Regulation (EU) 596/2014 (MAR), encompassing information relating to the Transaction, and is disclosed in accordance with the Company’s obligations under Article 17 of MAR.

For the purposes of MAR and Article 2 of the Commission Implementing Regulation (EU) 2016/1055, this announcement is being made on behalf of the Company by Julien Cotta, Chief Financial Officer and Company Secretary.

*Duaklir® is a registered trademark in certain European countries; the U.S. trademark is to be confirmed

Circassia will host an analyst meeting today at 09.30 GMT. For further details please contact Mo Noonan on +44 (0)20 3727 1390 or mo.noonan@fticonsulting.com.

About Circassia
Circassia is a specialty pharmaceutical business with established commercial infrastructure, marketed products and a portfolio of particle-engineered treatments targeting major market opportunities. Circassia sells its novel, market-leading NIOX® asthma management products directly to specialists in the United States, United Kingdom and Germany. Its products are also promoted in a number of other countries by the Company’s network of partners.

Circassia’s broad-based development pipeline includes a range of respiratory medicines. The Company’s lead asthma treatment, Fliveo®, targets substitution of GSK’s Flixotide® pMDI and is approved in the UK.  Circassia is also developing a direct substitute for Seretide® pMDI, Seriveo®.  In addition, the Company’s pipeline includes a number of inhaled medicines for chronic obstructive pulmonary disease, including single and combination dose products.  For more information on Circassia please visit www.circassia.com.

IMPORTANT NOTICE 

Forward-looking statements

This announcement, including its Appendix, contains forward-looking statements, including but not limited to statements about financial conditions, results of operations and business of Circassia, Circassia’s plans and objectives and the development and commercialisation of the Products. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future and therefore are based on current beliefs and expectations about future events. Forward-looking statements are not guarantees of future performance and the Group’s actual operating results and financial condition, and the development of the industry in which it operates may differ materially from those made in or suggested by the forward-looking statements contained in this announcement. In addition, even if the Group’s operating results, financial condition and liquidity, and the development of the industry in which the Group operates are consistent with the forward-looking statements contained in this announcement, those results or developments may not be indicative of results or developments in subsequent periods. Accordingly, prospective investors should not rely on these forward-looking statements. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. None of the Company, the Directors or the Sponsor undertake any obligation nor do they intend to revise or update any document unless required to do so by applicable law, the Financial Conduct Authority’s (the “FCA’s”) Prospectus Rules (the “Prospectus Rules”) and the FCA’s Disclosure Guidance and Transparency Rules (the “Disclosure Guidance and Transparency Rules”).

This announcement and the information contained in it is restricted and is not for release, publication or distribution, directly or indirectly, in whole or in part, in, into or from the United States (including its territories and possessions, any state of the United States and the District of Columbia, collectively the “United States”), Australia, Canada, Japan or South Africa or any other jurisdiction where to do so might constitute a violation of local securities laws or regulations (each an “Excluded Territory”). The information in this announcement may not be forwarded or distributed to any other person and may not be reproduced in any manner whatsoever. Any forwarding, distribution, reproduction, or disclosure of this information in whole or in part is unauthorised. Failure to comply with this directive may result in a violation of the Securities Act or the applicable laws of other jurisdictions.

This announcement is for information purposes only and does not constitute an offer or invitation to acquire or subscribe for the Consideration Shares to or by anyone in any Excluded Territory or to any person to whom it is unlawful to make such offer or invitation. Any failure to comply with these restrictions may constitute a violation of the securities laws of such jurisdictions. Subject to certain exceptions, the securities referred to herein may not be offered or sold in any Excluded Territory or to, or for the account or benefit of any national resident or citizen of any Excluded Territory. This announcement does not constitute or form part of an offer to sell securities in the United States. The Consideration Shares have not been and will not be registered under the Securities Act or under any securities laws or with any securities regulatory authority of any state or other jurisdiction of the United States. The Consideration Shares may not be offered, sold, resold, taken up, transferred, delivered or distributed, directly or indirectly, into or within the United States absent registration under the Securities Act or an available 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 Consideration Shares in the United States. The Consideration Shares are “restricted securities” within the meaning of Rule 144(a)(3) under the Securities Act and no representation is made as to the availability of the exemption provided by Rule 144 for resales of any Consideration Shares. Subject to certain exceptions, no action has been taken by the Company or by the Sponsor that would permit an offer of the Consideration Shares or possession or distribution of this announcement in the Excluded Territories or any other jurisdiction where action for that purpose is required, other than the United Kingdom. No public offering of the shares referred to in this announcement is being made.

This announcement has been issued by, and is the sole responsibility of, the Company. No representation or warranty, express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by the Sponsor or by any of its respective affiliates or agents as to or in relation to, the accuracy or completeness of this announcement or any other written or oral information made available to or publicly available to any interested party or its advisers, and any liability therefore is expressly disclaimed.

Numis Securities Limited (“Numis”), which is authorised and regulated by the Financial Conduct Authority in the United Kingdom, is acting solely for the Company in relation to the Transaction and nobody else as a client in relation to the Transaction and will not be responsible to anyone other than Circassia for providing the protections afforded to the clients of Numis or for providing advice in relation to the Transaction.

J.P. Morgan Securities plc (which conducts its UK investment banking activities under the marketing name, J.P. Morgan Cazenove), which is authorised in the United Kingdom by the Prudential Regulation Authority and regulated in the United Kingdom by the Prudential Regulatory Authority and by the Financial Conduct Authority, is acting as joint Corporate Broker for Circassia and for no-one else in connection with the proposed Transaction referred to in this document and is not, and will not be, responsible to anyone other than Circassia for providing the protections afforded to clients of J.P. Morgan Securities plc, nor for providing advice in connection with any of the matters described in this document.

Apart from the responsibilities and liabilities, if any, which may be imposed on the Sponsor by the Financial Service and Markets Act 2000, as amended, or the regulatory regime established thereunder, or by the London Stock Exchange or the Listing Rules, or under the regulatory regime of any jurisdiction where exclusion of liability under the relevant regulatory regime would be illegal, void or unenforceable, neither the Sponsor nor any of its respective affiliates, directors, officers, employees or advisers accept any responsibility whatsoever for, or makes any representation or warranty, express or implied, as to the contents of this announcement, including its accuracy or completeness, or for any other statement made or purported to be made by it, or on behalf of it, the Company, the Directors or any other person, in connection with the Company, the Consideration Shares or the Transaction, and nothing in this document should be relied upon as a promise or representation in this respect, whether or not to the past or future. The Sponsor and its respective affiliates, directors, officers, employees and advisers accordingly disclaims to the fullest extent permitted by law all and any responsibility or liability whatsoever, whether arising in tort, contract or otherwise (save as referred to above), which it might otherwise have in respect of this announcement or any such statement.

The distribution of this announcement and the offering of the Consideration Shares in certain jurisdictions other than the United Kingdom may be restricted by law.

Statements contained in this announcement regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future.

No statement in this announcement is or is intended to be a profit forecast or profit estimate or to imply that the earnings of the Company for the current or future financial years will necessarily match or exceed the historical or published earnings of the Company. The price of shares and the income from them may go down as well as up and investors may not get back the full amount invested on disposal of the shares.

The Consideration Shares to be issued pursuant to the Transaction will not be admitted to trading on any stock exchange other than on the main market for listed securities operated by the London Stock Exchange.

Neither the content of the Company’s website nor any website accessible by hyperlinks on the Company’s website is incorporated in, or forms part of, this announcement.