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 Annual Report and Financial Statements will be available on the Group’s website later today.
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.”
Contacts
Acacia Pharma Group plc
Mike Bolinder, CEO
Gary Gemignani, CFO
+44 1223 919760 / +1 317 505 1280
IR@acaciapharma.com
Citigate Dewe Rogerson (Financial PR)
Mark Swallow, Frazer Hall, David Dible
+44 20 7638 9571
acaciapharma@citigatedewerogerson.com
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 pipeline aims to address.
Acacia Pharma's lead product, BARHEMSYS® (intravenous amisulpride) for postoperative nausea & vomiting (PONV), has been approved by the US FDA, with US launch planned for H2 2020.
Byfavo™ (intravenous remimazolam), an ultra-short-acting and reversible sedative/anesthetic for use during invasive medical procedures, such as colonoscopy and bronchoscopy, is in-licensed from Cosmo Pharmaceuticals for the US market. The NDA for Byfavo has been filed with the US FDA and the target PDUFA action date is 5 April 2020.
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 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 ISIN code GB00BYWF9Y76 and ticker symbol ACPH.
About BARHEMSYS®
BARHEMSYS is a low dose intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride, which Acacia Pharma has developed and patent-protected for the management of PONV.
BARHEMSYS is indicated in adults for:
- treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis; and
- prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.
About PONV
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 painkillers and is particularly common following gynecological, abdominal, breast, eye and ear operations, especially those lasting an hour or more. PONV has been ranked as the most undesirable of all surgical complications in some patient surveys, even worse than pain.
Acacia Pharma estimates that approximately 65 million surgical procedures are conducted in the US each year that are eligible for antiemetic use to prevent PONV. Based on market research, Acacia Pharma estimates that the total market in the US for high risk prophylactic and rescue treatment comprises an estimated 34 million patients annually.
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.
Attachment
