02/18/2021 | Press release | Distributed by Public on 02/18/2021 06:24
THIS ANNOUNCEMENT CONTAINS REGULATED INFORMATION. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED IN ARTICLE 7 OF THE MARKET ABUSE REGULATION (EU) NO 596/2014
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, INTO OR WITHIN THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE IT IS UNLAWFUL TO DISTRIBUTE THIS ANNOUNCEMENT
Acacia Pharma Group plc
Proposed Capital Raising by way of a Placing of New Ordinary Shares and Update on Early Positive Market Reception to US Launch of BARHEMSYS®
Cambridge, UK and Indianapolis, US - 18 February 2021, 13:15 CET: Acacia Pharma Group plc ('Acacia Pharma' or the 'Company') (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, announces that it intends to raise EUR 20 million in new ordinary shares (the 'New Ordinary Shares'), by means of an accelerated bookbuild offering (the 'Placing'), with the possibility to increase the size of the Placing.
The Company also provides a brief update on the early positive market reception to the US launch of BAHREMSYS®. To date, approximately 90% of hospitals that have reviewed BARHEMSYS® for addition to their formulary have placed the drug on formulary resulting in 90 accounts across the US where the product is currently available on formulary.
'I am delighted to report that the US launches of both BARHEMSYS® and BYFAVO™ are proceeding extremely well despite the challenging operating environment imposed by Covid-19 related restrictions,' commented Mike Bolinder, Acacia Pharma's CEO. 'As for any US hospital product launch, two of the most important key performance indicators of early product acceptance in the market are the number of accounts that have placed the drug on their hospital formulary of approved products and the percentage of hospitals that have reviewed the product and decided to place it on their formulary. The launch of BARHEMSYS®, in its first full quarter with our salesforce in place, has exceeded the Company's expectations and compares very favourably to recent comparable US hospital product launches. This is a great start by our focused and experienced sales force and further positive decisions for inclusions on additional hospital formularies are anticipated in the near term. We will provide a more detailed update on the significant progress that we have made in launching both products at the time of the full year results scheduled for the last week of March.'
The net proceeds of the Placing are intended to be used:
The price at which the New Ordinary Shares will be issued (the 'Placing Price') and the total number of New Ordinary Shares to be issued in the Placing will be determined by way of an accelerated bookbuild process (the 'Bookbuild'). It is intended that approximately EUR 20 million in gross proceeds will be raised from the Placing.
Bank Degroof Petercam SA/NV ('Degroof Petercam') is acting as Sole Bookrunner and Listing Agent (the 'Sole Bookrunner' or the 'Bank') in connection with the Placing.
The Bookbuild will start immediately following this announcement. Pricing and allocation of the New Ordinary Shares in the Placing is expected to take place before beginning of trading on Euronext Brussels at 09:00 CET on 19 February 2021. The exact timing of closing of the Bookbuild, pricing and allocation is at the discretion of the Company and the Sole Bookrunner. The Company will announce the results of the Placing after closing of the Bookbuild in a subsequent announcement.
The Company has requested the Belgian Financial Services and Markets Authority ('Belgian FSMA') to suspend trading in Acacia Pharma's shares on Euronext Brussels during the Bookbuild. Trading in the shares is expected to resume following the publication of the results of the Placing.
In connection with the Placing, the Company has agreed to a lock-up undertaking, not to issue additional shares for a period of 90 days following settlement of the Placing. In addition, in connection with the Placing, senior managers and directors of the Company as well as Cosmo Technologies Limited ('Cosmo'), a substantial shareholder in the Company, have agreed not to sell any shares in Acacia Pharma for a period of 90 days following the settlement of the Placing, subject to customary exceptions.
If needed, Degroof Petercam, acting as Settlement Agent, will enter into a share swap agreement with Cosmo in order to deliver listed shares to all investors who receive allocated shares in the private placement ('Share Swap Agreement'). As part of the Share Swap Agreement, Cosmo will deliver existing and listed shares to the Settlement Agent. Cosmo will receive in exchange the same number of newly issued non-listed shares ('Non-Listed Shares').
Application will be made to Euronext Brussels for admission of the New Ordinary Shares (not subject to the aforementioned Share Swap Agreement) issued pursuant to the Placing to trading on the regulated market of Euronext Brussels ('Admission'). It is expected that Admission will take place on or around 08:00 CET on 23 February 2021 (or such later time or date as the Bank may agree with the Company) and that unconditional dealings in the New Ordinary Shares issued pursuant to the Placing will commence at the same time. The Placing is conditional upon, inter alia, Admission becoming effective and the placing agreement between the Company and the Bank not being terminated in accordance with its terms. The Non-Listed Shares that Cosmo will receive under the Share Swap Agreement will be listed on Euronext Brussels upon approval of a listing prospectus by the Belgian FSMA on a later date.
Acacia Pharma Group plc
The Officers' Mess, Royston Road, Duxford, Cambridge, CB22 4QH, United Kingdom
Company number 9759376
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy. The Company has identified important and commercially attractive unmet needs in these areas that its product portfolio aims to address.
Acacia Pharma's first product, BARHEMSYS® (amisulpride injection) is marketed in the US for the management of postoperative nausea & vomiting (PONV).
BYFAVO™ (remimazolam) for injection, a very rapid onset/offset IV benzodiazepine sedative is approved and launched in the US for use during invasive medical procedures in adults lasting 30 minutes or less, such as colonoscopy and bronchoscopy. BYFAVO is in-licensed from Paion UK Limited for the US market.
APD403 (intravenous and oral amisulpride), a selective dopamine antagonist for chemotherapy induced nausea & vomiting (CINV) has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.
Acacia Pharma has its US headquarters in Indianapolis, IN and its R&D operations are centered in Cambridge, UK. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.
These materials are not for release, publication or distribution, directly or indirectly, in whole or in part, into or within the United States (including its territories and possessions, any State of the United States and the District of Columbia). These materials are for informational purposes only and do not constitute or form part of any offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933, as amended (the 'US Securities Act'), or under the securities laws of any state or other jurisdiction of the United States. The securities referred to herein may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the US 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 securities in the United States.
This press release (and the information contained herein) is not for release, publication or distribution, directly or indirectly, in whole or in part, into or within Australia, Canada, Japan or South Africa or any other jurisdiction where to do so might constitute a violation of the relevant laws or regulations of such jurisdiction.
The offer set out in this press release is only addressed to and is only directed at persons in member states of the European Economic Area (the 'EEA') who are 'qualified investors' within the meaning of Article 2 (e) of Regulation (EU) 2017/1129. In the United Kingdom, this press release is addressed solely to, and is directed solely at, persons who (i) have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the 'Order') or (ii) are persons falling within Article 49(2)(a) to (e) of the Order and other persons to whom it may lawfully be communicated (all such persons together being referred to as 'relevant persons'). These materials are addressed only to, and directed only at, relevant persons and qualified investors and must not be acted on or relied on (i) in the United Kingdom, by persons who are not relevant persons or (ii) in any member state of the EEA, by persons who are not qualified investors. Any investment or investment activity to which these materials relate is available only to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire any securities referred to herein will be engaged in only with, in the United Kingdom, relevant persons, and in any member state of the EEA, qualified investors.
This press release does not constitute, or form part of, any offer or any solicitation of an offer to subscribe for any shares or other securities.
Information to distributors
Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended ('MiFID II'); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the 'MiFID II Product Governance Requirements'), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any 'manufacturer' (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the New Ordinary Shares have been subject to a product approval process, which has determined that the New Ordinary Shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the 'Target Market Assessment'). Notwithstanding the Target Market Assessment, distributors should note that: the price of the New Ordinary Shares may decline and investors could lose all or part of their investment; the New Ordinary Shares offer no guaranteed income and no capital protection; and an investment in the New Ordinary Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Placing. Furthermore, it is noted that, notwithstanding the Target Market Assessment, the Sole Bookrunner will only procure investors who meet the criteria of professional clients and eligible counterparties.
For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the New Ordinary Shares.
Each distributor is responsible for undertaking its own target market assessment in respect of the New Ordinary Shares and determining appropriate distribution channels.
Forward looking statements
This announcement may include certain forward-looking statements, which are based on current expectations and projections about future events. These statements may include, without limitation, any statements preceded by, followed by or including words such as 'believe', 'expect', 'intend', 'may', 'plan', 'will', 'should', 'could' and other words and terms of similar meaning or the negative thereof. Forward-looking statements may and often do differ materially from actual results. These forward-looking statements are subject to risks, uncertainties and assumptions about the Company and its subsidiaries and investments, including, among other things, the development of its business, trends in its operating industry, and future capital expenditures and acquisitions. By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Any forward-looking statements reflect the Company's current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Group's business, results of operations, financial position, prospectus, growth or strategies and the industry in which it operates. Save as required by law or applicable regulation, the Company and its affiliates expressly disclaim any obligation or undertaking to update, review or revise any forward-looking statement contained in this announcement whether as a result of new information, future developments or otherwise. Forward-looking statements speak only as of the date they are made.