29 March 2021
Results for the Year ended 31 December 2020
- US commercial infrastructure successfully built and fully operational
- Highly experienced sales, marketing, medical affairs, commercial operations teams in place
- Nationwide salesforce deployed against ~900 initial targeted hospital accounts since mid-October 2020
- Two high-potential products approved by the US Food and Drug Administration (FDA) in 2020
- BARHEMSYS (amisulpride injection)
- Approved February 2020 in the US with a broad label for the treatment and prevention of postoperative nausea & vomiting (PONV)
- First and only antiemetic approved for the rescue treatment of PONV in patients who have failed prior prophylaxis
- Approximately 16m surgical patients each year in the US suffer from PONV despite receiving prophylaxis (ref.1)
- Estimated $2.7 billion annual total addressable market (ref.2)
- BYFAVO (remimazolam injection)
- US commercial rights in-licensed from Cosmo Pharmaceuticals NV (“Cosmo”) in January 2020
- Approved July 2020 for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
- Key target: 40m procedures a year in US, including 25m gastro-intestinal procedures (ref.3)
- Estimated >$1.5 billion annual total addressable market (ref.4)
- BARHEMSYS (amisulpride injection)
- Commercialization off to excellent start, with strong early formulary uptake
- After deploying our sales team in mid-October, to date BARHEMSYS has been added to formulary at 120 institutions – Pharmacy & Therapeutics (P&T) Committee review success > 85%
- Strong appreciation of clinical and health economic benefits of BARHEMSYS
- BYFAVO launched at end of January 2021 and in eight weeks of launch is already approved on formulary in seven accounts
- High level of enthusiasm from healthcare professionals for first major sedative launch in two decades
- Management and Board Changes
- Gary Gemignani appointed new CFO following planned succession succeeding Christine Soden who retired as CFO and from the Board in February 2020
- Patrick Vink (Chairman), Pieter van der Meer and Johan Kördel stepped down from the Board of Directors at the 2020 AGM
- Scott Byrd, a non-executive director of Acacia Pharma, was elected as Chairman at the AGM and Alessandro Della Chá, CEO of Cosmo Pharmaceuticals N.V. was appointed as a non-executive director
- Named BEL Small Cap Company of the Year for the second consecutive year
- Loss after tax for the year ended 31 December 2020 of $33.5m (2019: $22.8m):
- The operating loss increased by $8.5m to $30.9m (2019: $22.4m), reflecting the investment in our US commercial infrastructure and product launch preparations
- R&D expenses $0.1m (2019: $3.9m) with the reduction reflecting lower R&D activities on completion of BARHEMSYS clinical program, together with a $1.4m credit on reversing certain inventory provisions on the approval of BARHEMSYS
- Sales and marketing expenses $19.4m (2019: $14.0m) reflecting increased activities leading up to the planned launch of BARHEMSYS and BYFAVO
- General and administrative expenses $11.6m (2019: $4.4m) with 2020 costs higher as a result of fundraising activities, staff costs and amortisation of intangibles
- Cash and cash equivalents as at 31 December 2020 of $46.7m (2019: $17.0m)
- Balance sheet strengthened through €20m equity investment from Cosmo, €25m loan from Cosmo, together with €25m equity financing in August 2020
- Additional equity financing undertaken in February 2021 with gross proceeds of €27m
- Calculations based on available procedural data, applied Compound Annual Growth Rate and quantitative market research responses as follows: National Hospital Discharge Survey, 2006; National Survey of Ambulatory Surgery, 2006 (as revised in 2009); Source Healthcare; NCHS 2005; Life Science Strategy Group, LLC Market Research; Apfel et al.,2004.
- Based on the calculations in (1) multiplied by the number of doses per patient at a WAC price of $85 per 10mg dose.
- iData Research, US Market Report Procedure Numbers for Gastrointestinal Endoscopic Devices February 2019; American Society of Anesthesiologists, Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018; and Quantitative Market Research prepared by The Link Group for Cosmo Technologies (March 2019).
- Based on the calculation in (4) multiplied by the number of doses per patient at a WAC price of $39 per dose.
Acacia Pharma Group plc
Mike Bolinder, CEO
Gary Gemignani, CFO
+44 1223 919760 / +1 317 505 1280
Mark Swallow, Frazer Hall, David Dible
Citigate Dewe Rogerson
+44 20 7638 9571
Media in Belgium and the Netherlands
Chris Van Raemdonck
+32 499 58 55 31
Acacia Pharma Group plc
The Officers’ Mess, Royston Road, Duxford, Cambridge, CB22 4QH, United Kingdom
Company number 9759376
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 portfolio aims to address.
Acacia Pharma's first product, BARHEMSYS® (amisulpride injection) is available in the US for the management of postoperative nausea & vomiting (PONV).
BYFAVO™ (remimazolam) for injection, a very rapid onset/offset IV benzodiazepine sedative is approved and launched in the US for use during invasive medical procedures in adults lasting 30 minutes or less, such as colonoscopy and bronchoscopy. BYFAVO is in-licensed from Paion UK Limited for the US market.
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 has its US headquarters in Indianapolis, IN and its R&D operations are centred in Cambridge, UK. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.
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, prospects, 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.
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