Acacia Pharma Group plc Results For The Year Ended 31 December 2020
March 29 2021 - 12:00AM
UK Regulatory
TIDMACPH
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(R) and BYFAVO(TM) 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
https://www.globenewswire.com/Tracker?data=RfqhkFZTQVdPiSmQRfc9WbeCfSrh5Q7n4FeWv77uhSyMK-sgMRvk-8co1pi30aFZ8546FBdL4U1t6HimhYXvXjuIjoYetev3cQ89zdOKbM7bsj5VsERex11PPoo865MLKpq9y2FMIuPXm87ROgh8-g==
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 >$1.5 billion annual total addressable market4
-- Commercialization off to excellent start, with strong early formulary
uptake
-- After deploying our sales team in mid-October, to date BARHEMSYS
has been added to formulary at 120 institutions -- Pharmacy &
Therapeutics (P&T) Committee review success > 85%
-- Strong appreciation of clinical and health economic benefits of
BARHEMSYS
-- BYFAVO launched at end of January 2021 and in eight weeks of
launch is already approved on formulary in seven accounts
-- High level of enthusiasm from healthcare professionals for first
major sedative launch in two decades
-- Management and Board Changes
-- Gary Gemignani appointed new CFO following planned succession
succeeding Christine Soden who retired as CFO and from the Board
in February 2020
-- Patrick Vink (Chairman), Pieter van der Meer and Johan Kördel
stepped down from the Board of Directors at the 2020 AGM
-- Scott Byrd, a non-executive director of Acacia Pharma, was elected
as Chairman at the AGM and Alessandro Della Chá, CEO of Cosmo
Pharmaceuticals N.V. was appointed as a non-executive director
-- Named BEL Small Cap Company of the Year for the second consecutive year
Financial Highlights
Results are presented in US$, 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
-- Cash and cash equivalents as at 31 December 2020 of $46.7m (2019:
$17.0m)
-- Balance sheet strengthened through EUR20m equity investment from Cosmo,
EUR25m loan from Cosmo, together with EUR25m equity financing in August
2020
-- Additional equity financing undertaken in February 2021 with gross
proceeds of EUR27m
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
References
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.
Contacts
Acacia Pharma Group plc International Media
Mike Bolinder, CEO Mark Swallow, Frazer Hall, David
Gary Gemignani, CFO Dible
+44 1223 919760 / +1 317 505 1280 Citigate Dewe Rogerson
IR@acaciapharma.com +44 20 7638 9571
acaciapharma@citigatedewerogerson.com
US Investors Media in Belgium and the Netherlands
LifeSci Advisors Chris Van Raemdonck
Irina Koffler +32 499 58 55 31
+1 917-734-7387 chrisvanraemdonck@telenet.be
ikoffler@lifesciadvisors.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 portfolio aims to address.
Acacia Pharma's first product, BARHEMSYS(R) (amisulpride injection) is
available in the US for the management of postoperative nausea &
vomiting (PONV).
BYFAVO(TM) (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.
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
https://ml-eu.globenewswire.com/Resource/Download/4f8bf820-e12e-4921-bb56-386345a2aa44
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