Acacia Pharma Group plc : Results for the year ended 31 December 2019

Cambridge, UK and Indianapolis, US – 2 March 2020: Acacia Pharma Group plc (“Acacia Pharma”, the “Group” or the “Company”) (EURONEXT: ACPH), 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, announces its results for the year ended 31 December 2019. The full results statement is attached. The full Annual Report and Financial Statements will be available on the Group’s website later today. The

Operating Highlights

•                     US Food and Drug Administration (FDA) approved the New Drug Application (NDA) for BARHEMSYS® (intravenous amisulpride) for the prevention and treatment of postoperative nausea & vomiting (PONV) in adult patients on 26 February 2020

• US launch planned in H2 2020

•                     Core US commercial infrastructure established, and key sales representatives identified

• Minimum 30 field managers planned to be in place prior to launch

•                     Product portfolio expanded through in-licensing of Byfavo™ (remimazolam), an ultra-short-acting and reversible sedative/anesthetic designed for use during invasive medical procedures, from Cosmo Pharmaceutical N.V. in January 2020

• PDUFA date for Byfavo of 5 April 2020

•                     Planned management changes

• Mike Bolinder appointed as Chief Executive Officer on 1 August 2019 upon Julian Gilbert stepping down
• Gary Gemignani appointed as Chief Financial Officer on 29 February 2020 succeeding Christine Soden, who also stepped down from the Board of Directors

Financial Highlights

Results are presented in US$, reflecting the currency of the majority of expected costs and revenues

•                     Loss after tax for the year ended 31 December 2019 $22.8m (2018: $20.7m):

• R&D expenses $3.9m (2018: $5.0m) with the reduction reflecting lower R&D activities on completion of BARHEMSYS clinical program
• Sales and marketing expenses $14.0m (2018: $9.3m) reflecting increased activities leading up to the planned launch of BARHEMSYS
• General and administrative expenses $4.4m (2018 $5.7m) with 2018 costs higher as a result of the Euronext IPO and fundraising activities

•                     Cash and cash equivalents as at 31 December 2019 $17.0m (2018: $37.4m)

• Balance sheet strengthened post-year end with €10m ($11.2m) equity investment in January and €10m ($11.2m) loan facility, which became available following BARHEMSYS approval, each from Cosmo Pharmaceuticals

Summary and outlook for 2020 

The Directors of Acacia Pharma are pleased with the progress made in the year in bringing BARHEMSYS to US regulatory approval and in building an effective US commercial operation. Detailed work undertaken over the last two years has only enhanced the Directors’ belief in the commercial and medical value of delivering a new solution to better manage PONV and of the commercial prospects for BARHEMSYS. The addition of the rights to Byfavo, equity investment and debt availability has significantly enhanced the Group’s resources and ability to deliver long-term value for shareholders.

Commenting on the results, Mike Bolinder, Chief Executive Officer, said: “Our vision is to become a leading US hospital pharmaceutical company and with the approval of BARHEMSYS and in-licensing of Byfavo, we now believe we are well positioned to achieve this aim in the medium term. Receiving a second complete response letter for BARHEMSYS from the FDA last year was clearly disappointing, but we have now successfully completed this critical step. I am truly grateful to our employees for their dedication and loyalty during what was a challenging year and to our shareholders for their continued support.”