ACACIA PHARMA GROUP PLC
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
Results for the year ended
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,
“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
- 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
- Approved
- 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 >
$1.5 billion annual total addressable market4
- US commercial rights in-licensed from Cosmo Pharmaceuticals NV (“Cosmo”) in
- BARHEMSYS (amisulpride injection)
- Commercialization off to excellent start, with strong early formulary uptake
- After deploying our sales team in mid-October, to date BARHEMSYS has been added to formulary at 120 institutions –
Pharmacy & Therapeutics (P&T) Committee review success > 85% - Strong appreciation of clinical and health economic benefits of BARHEMSYS
- BYFAVO launched at end of
January 2021 and in eight weeks of launch is already approved on formulary in seven accounts - High level of enthusiasm from healthcare professionals for first major sedative launch in two decades
- After deploying our sales team in mid-October, to date BARHEMSYS has been added to formulary at 120 institutions –
- Management and Board Changes
Gary Gemignani appointed new CFO following planned succession succeedingChristine Soden who retired as CFO and from the Board inFebruary 2020 Patrick Vink (Chairman),Pieter van der Meer and Johan Kördel stepped down from the Board of Directors at the 2020 AGMScott Byrd , a non-executive director of Acacia Pharma, was elected as Chairman at the AGM and Alessandro Della Chá, CEO of Cosmo Pharmaceuticals N.V. was appointed as a non-executive director
Named BEL Small Cap Company of the Year for the second consecutive year
Financial Highlights
Results are presented in US$, reflecting the currency of the majority of expected costs and revenues
- Loss after tax for the year ended
31 December 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
- The operating loss increased by
- 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
- Additional equity financing undertaken in
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.
Belgium Toll Free: 0800 746 68
Netherlands Toll Free: 0800 022 9132
US
References
1. Calculations based on available procedural data, applied Compound Annual Growth Rate and quantitative market research responses as follows:
2. Based on the calculations in (1) multiplied by the number of doses per patient at a WAC price of
3. iData Research, US Market Report Procedure Numbers for Gastrointestinal Endoscopic Devices
4. Based on the calculation in (4) multiplied by the number of doses per patient at a WAC price of
Contacts
+44 1223 919760 / +1 317 505 1280 IR@acaciapharma.com | International Media +44 20 7638 9571 acaciapharma@citigatedewerogerson.com |
| US Investors +1 917-734-7387 ikoffler@lifesciadvisors.com | Media in +32 499 58 55 31 chrisvanraemdonck@telenet.be |
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
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
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, 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.
Attachment
- Acacia Pharma Group plc Preliminary Results for the year ended
31 December 2020
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