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This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
Acacia Pharma Group plc
Results for the year ended 31 December 2020
Cambridge, UK and Indianapolis, US – 29 March 2021, 07:00 CEST: 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 2020 and provides an update on progress with the commercialization of BARHEMSYS® and BYFAVO™ in the United States.
A presentation by Acacia Pharma’s senior management team will be webcast live today at 14.30 CEST (08.30 EST) and participants can register by clicking here or from www.acaciapharma.com. A replay will be available after the event at the same link.
International conference call dial-in details are noted below.
The results report and presentation will be available at www.acaciapharma.com in the Investors section from 07.00 CEST today.
The full Annual Report and Financial Statements will be available on the Group’s website by 31 March.
Commenting on the results, Mike Bolinder, Chief Executive Officer, said: “Our vision to become a leading US hospital pharmaceutical company is on the road to being realized. The US approval and launch in the last year of two major new products in BARHEMSYS and BYFAVO is a tremendous achievement, practically unprecedented for a company of our size.
“Our early progress on formulary adoption for BARHEMSYS reflects the unmet need that exists in PONV and strong underlying demand for our product, our outstanding and extremely experienced commercial team and salesforce, as well as our well-constructed, well-executed launch plans. During 2021, we aim to continue gaining formulary access in our initial targeted accounts, as this will lay the strong foundation for significant revenue pull-through from 2022 onwards.
“Acacia Pharma is now at an exciting stage in its path to long-term commercial success, and we intend to continue to resolutely execute our plans as we bring these important new treatments to patients and at the same time build further significant value for our shareholders. I am once again truly grateful to our employees for their dedication and remarkable efforts during this year of outstanding progress against the challenging backdrop of the COVID-19 pandemic, and to our shareholders for their continued support.”
Operating Highlights for 2020 and Significant Post-period Updates
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 prophylaxis1
Estimated $2.7 billion annual total addressable market2
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 procedures3
Estimated >$1.5 billion annual total addressable market4
Commercialization off to excellent start, with strong early formulary uptake
After deploying our sales team in mid-October, to date BARHEMSYS has been added to formulary at 120 institutions – Pharmacy & Therapeutics (P&T) Committee review success > 85%
Strong appreciation of clinical and health economic benefits of BARHEMSYS
BYFAVO launched at end of January 2021 and in eight weeks of launch is already approved on formulary in seven accounts
High level of enthusiasm from healthcare professionals for first major sedative launch in two decades
Management and Board Changes
Gary Gemignani appointed new CFO following planned succession succeeding Christine Soden who retired as CFO and from the Board in February 2020
Patrick Vink (Chairman), Pieter van der Meer and Johan Kördel stepped down from the Board of Directors at the 2020 AGM
Scott Byrd, a non-executive director of Acacia Pharma, was elected as Chairman at the AGM and Alessandro Della Chá, CEO of Cosmo Pharmaceuticals N.V. was appointed as a non-executive director
Named BEL Small Cap Company of the Year for the second consecutive year
Results are presented in US$, reflecting the currency of the majority of expected costs and revenues
Loss after tax for the year ended 31 December 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
Summary and Outlook for 2021
The Directors of Acacia Pharma are pleased with the excellent progress made since the beginning of 2020 in bringing two products forward to approval and now launch in the important US market. BARHEMSYS and BYFAVO are highly complementary products that together can efficiently utilize the commercial infrastructure that the Company has now built in the US.
The addition of the rights to BYFAVO along with the accompanying equity investment and debt facility from Cosmo as well as the recent equity raises have enhanced the Group’s ability to facilitate a successful launch and roll out of these products.
The early success with hospital formulary access for BARHEMSYS has confirmed the Directors’ belief in the strong product profile and compelling health economic arguments in favour of its adoption and use. This is an important first step to building a solid and growing sales platform for the product.
While it remains early days in the launch of BYFAVO, the Directors believe that it too offers significant medical and commercial value that will be viewed favorably by formulary committees and payors, as well as doctors and patients.
Conference call dial-in details
To join the conference call by telephone, please dial-in 5-10 minutes prior to the start using the password Acacia Pharma and any of the phone numbers provided below.
UK/Standard International dial-in: +44 (0) 33 0551 0200
UK Toll Free: 0808 109 0700
Belgium Toll Free: 0800 746 68
Netherlands Toll Free: 0800 022 9132
US New York: +1 212 999 6659
USA Toll Free: +1 866 966 5335
1. 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.
2. Based on the calculations in (1) multiplied by the number of doses per patient at a WAC price of $85 per 10mg dose.
3. 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).
4. 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
Media in Belgium and the Netherlands
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.