Cambridge, UK and Indianapolis, US – 27 February 2019: Acacia Pharma Group plc (“Acacia Pharma”, the “Group” or the “Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients, announces its results for the year ended 31 December 2018. A conference call will take place at 3:00pm CET today (details below) and the presentation will be available on the Group’s website in the Investors section (Financial Reports and Presentations) shortly before.
Operating Highlights
IPO and listing on Euronext Brussels completed in March
US infrastructure established in preparation for commercialising BARHEMSYS™, pending regulatory approval
Revised target PDUFA date of 5 May 2019 for review of BARHEMSYS NDA by US FDA
Complete Response Letter from FDA received 5 October 2018 - no issues cited over safety or efficacy of BARHEMSYS
Rapid re-submission and acceptance of NDA
Publication of positive Phase 3 clinical study results of BARHEMSYS in post-operative nausea & vomiting (PONV) in leading peer-reviewed publications focused on surgical care and anaesthesiology
Positive outcomes from additional safety study with BARHEMSYS enhance earlier clinical results (announced January 2019)
Board strengthened with appointments of Dr John Brown and Edward Borkowski as Non-Executive Directors
Financial Highlights
Loss after tax of £15.5m (2017: £6.2m) with increases reflecting costs relating to Euronext listing and preparations for the commercialisation of BARHEMSYS in the US:
R&D expenses (£2.3m higher at £3.8m)
G&A expenses (£2.8m higher at £4.3m)
Sales and marketing costs (£6.9m higher at £6.9m)
IPO raised net proceeds of £34.1m in March 2018
New $30m term loan facility secured with Hercules Technology Growth Capital
$10m drawn in June 2018 and existing Silicon Valley Bank loan (£5.2m) repaid
Strong cash position at year end of £29.4m (2017: £3.1m)
Commenting on the results, Dr Julian Gilbert, Chief Executive Officer, said: “Our vision is to become a leading US hospital pharmaceutical company. Healthcare systems around the world increasingly are focusing on patient outcomes and enhancing recovery after surgery. Improved management of nausea and vomiting in the post-operative and chemotherapy settings can add significantly to patient well-being as well as potentially reducing the overall costs of care. We are building a scalable commercial platform in the US and we look forward to being able to bring BARHEMSYS to market to address the unmet needs in PONV. Receiving a complete response letter from the FDA in October was clearly disappointing, but the speed with which our team addressed this and resubmitted our NDA application was pleasing. I would like to thank our employees for their hard work and loyalty and our shareholders for their support.”
Conference call details
To join the conference call, please dial in 5-10 minutes prior to the start using phone numbers and password provided below.
Standard International Access +44 (0) 20 3003 2666
UK Toll Free 0808 109 0700
Belgium 0800 746 68
USA Toll Free 1 866 966 5335
Conference password acacia pharma