27 February 2019
Results for the year ended 31 December 2018
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.
- 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
- 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
Acacia Pharma Group plc
Julian Gilbert, CEO
Christine Soden, CFO
+44 1223 919760
Citigate Dewe Rogerson (Financial PR)
Mark Swallow, Shabnam Bashir, David Dible
+44 20 7638 9571
PONV is a common complication of surgery, occurring in approximately 30% of surgical patients and up to 80% of high-risk patients. It is associated with the use of anaesthetic gases and opioid pain-killers and is particularly common following gynaecological, abdominal, breast, eye and ear operations, especially those lasting an hour or more.
The Company estimates that approximately 65 million surgical procedures are conducted in the US each year that require injectable analgesia and are eligible for antiemetic use to prevent PONV. Based on market research, Acacia Pharma estimates that the total market in the US for prophylactic and rescue treatment comprises an estimated 34 million treatment events annually.
PONV has been ranked as the most undesirable of all surgical complications by patients and contributes significantly to patient anxiety and distress. PONV can delay hospital discharge; result in re-admission after in-patient procedures; and lead to day-case patients being admitted to hospital, all of which can result in significantly increased healthcare costs.
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients. The Group has identified important and commercially attractive unmet needs in nausea & vomiting and has discovered two product candidates based on the same active ingredient, amisulpride, to meet those needs.
The Group's lead project, BARHEMSYS™ for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. A New Drug Application (NDA) for BARHEMSYS is under review by the US Food and Drug Administration (FDA). Its sister project, APD403 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 is based in Cambridge, UK and its US operations are centred in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the under ISIN code GB00BYWF9Y76 and ticker symbol ACPH. www.acaciapharma.com
Forward looking statements
This announcement includes 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.