Dublin, Ireland – 15 December 2020: Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that, on 14 December 2020, Acacia Pharma Group plc (“Acacia”) (EURONEXT: ACPH) and Cosmo entered into an amendment agreement (the “Amendment Agreement”) being an amendment to the Investment Agreement between the parties dated 10 January 2020, pursuant to which Acacia and Cosmo agreed that, in exchange for Cosmo prioritising the packaging and labelling production run for BYFAVO™ for supply in the US, Acacia shall make the EUR 5 million payment due on the first commercial sale of BYFAVO™ in advance of the first commercial sale of BYFAVO™ and by no later than 31 December 2020.
Acacia Pharma is preparing to launch BYFAVO™ in the US in the coming weeks.
Payment will be settled by the Company issuing new ordinary shares in the share capital of the Company (the “New Ordinary Shares”) to Cosmo, at an issue price of EUR 2.38 each (being the 15-day volume weighted average price of the Company’s shares prior to the date of the Amendment Agreement). Listing and admission to trading of the New Ordinary Shares on Euronext Brussels remains, in accordance with the Investment Agreement, conditional upon the necessary regulatory approvals being obtained from the FCA and the Belgian FSMA.
The New Ordinary Shares will rank pari passu in all respects with the Company’s existing ordinary shares in issue. Following the receipt of the New Ordinary Shares, Cosmo’s stake in Acacia will increase from 20.52% to approx. 21.88%.
BYFAVO™ was approved by the US Food and Drug Administration (FDA) on 2 July 2020 for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. It received its Schedule IV designation from the US Drug Enforcement Administration (DEA) on 5 October 2020.
DEA scheduling requirements between July and October this year delayed the final approval and finalization of the BYFAVO™ label, leading Acacia Pharma to request Cosmo to prioritize the BYFAVO™ processing schedule during a time when its facility would typically be closed. The agreement to amend the timing for this payment was reached in consideration for Cosmo modifying its production schedule and expediting its packaging and labelling production for BYFAVO™.
This brings the total milestones received by Cosmo in 2020 as a result of the sublicence of its BYFAVO™ US rights to Acacia to EUR 45 million. An additional USD 105 million will also become payable by Acacia to Cosmo based on the achievement of BYFAVO™ commercial milestones yet to be achieved.
About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company focused on developing and commercialising products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of GI Genius™ its artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo® to Red Hill Biopharma Ltd. for the US and has licensed Relafalk® to Dr. Falk Pharma Gmbh for the EU and other countries. For additional information on Cosmo and its products please visit the Company’s website: www.cosmopharma.com
Calendar
Full Year Results 2020 March 26, 2021
Annual General Meeting, Amsterdam May 28, 2021
Contact
Niall Donnelly, CFO & Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 1 817 03 70
ndonnelly@cosmopharma.com
Disclaimer
Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.
This communication is not an offer of securities of any issuer. Securities may not be offered or sold in the United States absent registration or an exemption from the registration requirement of the US Securities Act of 1933.
This press release constitutes neither an offer to sell nor a solicitation to buy securities and it does not constitute a prospectus within the meaning of article 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any similar document. The offer will be made solely by means of, and on the basis of, a securities prospectus to be published. An investment decision regarding the securities to be publicly offered should only be made on the basis of the securities prospectus.
This press release is made to and directed only at (i) persons outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”), and (iii) high net worth individuals, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order. Any person who is not a relevant person should not act or rely on this press release or any of its contents.
This press release does not constitute an “offer of securities to the public” within the meaning of Directive 2003/71/EC of the European Union (the “Prospectus Directive”) of the securities referred to in it (the “Securities”) in any member state of the European Economic Area (the “EEA”). Any offers of the Securities to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities.