Interim Results for the Six Months ended 30 June 2020
13 Agosto 2020 - 3:00PM
Interim Results for the Six Months ended 30 June 2020
THIS ANNOUNCEMENT CONTAINS INSIDE
INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF EU REGULATION
596/2014.
Acacia Pharma Group plc
Interim Results for the Six Months ended
30 June 2020
- US approval for BARHEMSYS® for postoperative nausea &
vomiting (PONV)
- US approval of BYFAVO™ for procedural sedation
- Strategic agreement with Cosmo Technologies providing funding
for US commercialization
- Good progress with preparations for US launch in 2H 2020
Cambridge, UK and Indianapolis, US – 13
August 2020: Acacia Pharma Group plc (“Acacia
Pharma” or the “Company” and, together
with its subsidiaries, the “Group”) (EURONEXT:
ACPH), a commercial stage biopharmaceutical company focused on
developing and commercializing novel products to improve the care
of patients undergoing serious medical treatments such as surgery,
invasive procedures, or chemotherapy, announces its unaudited
interim results for the six-month period ended 30 June 2020.
Mike Bolinder, CEO of Acacia Pharma,
said: “The first half of 2020 was truly a transformative
period for the Company. We were delighted to gain FDA approval for
our first product, BARHEMSYS®, in February. We identified and
developed this product through an extensive and successful clinical
trials program and it is testament to the founders and employees of
the company for achieving this significant milestone.
“The in-licensing and subsequent US approval of
BYFAVO™ added a second product to strengthen our portfolio
targeting the anesthesiology market. We are now focused on building
the optimal commercial organization to launch both products in the
US, where we believe there is significant need for our new
products.
“The coronavirus has created many challenges for
the global healthcare system and supply chains. We believe it has
also created opportunity for our products, and that we will see
strong demand for both products given that they are designed in
part to improve procedural throughput to help address the current
surgical backlogs in hospitals and surgical centres that exist as a
result of the pandemic. We also believe that in making these new
products available, we can satisfy the demand for products
addressing PONV and procedural sedation owing to shortages of
supply that currently exist for the current standard-of-care drugs
for these indications.
“Our focus is now wholly on executing a
successful launch of BARHEMSYS® and BYFAVO™ in 2H 2020, which will
further accelerate our transition from an R&D-led company into
a commercial business bringing much needed treatments to patients
in the US. We look forward to an exciting time ahead and to
providing further updates on our progress.”
Operating Highlights (including
post-period updates)
- On 26 February 2020, the US Food and Drug Administration (FDA)
approved the New Drug Application (NDA) for BARHEMSYS® (amisulpride
injection), the Company’s first product approval, allowing its
commercialization in the US for the treatment and prevention of
postoperative nausea and vomiting (PONV).
- The label is the first to include rescue treatment in patients
who have failed prior prophylaxis, and also includes combination
prophylaxis with other antiemetics in higher risk patients, the two
key commercial unmet needs.
- On 27 July 2020, FDA approved a second supplier for the active
pharmaceutical ingredient (API) for BARHEMSYS®, supporting the
Group’s ability to provide a continuous, high-quality product
supply to meet the anticipated ongoing demand.
- On 2 July 2020, FDA approved the NDA for the Group’s second
product, BYFAVO™ (remimazolam), a rapid onset/offset IV
benzodiazepine sedative for injection, for the induction and
maintenance of procedural sedation in adults undergoing procedures
lasting 30 minutes or less, such as colonoscopy and bronchoscopy.
- BYFAVO™ was in-licensed on 10 January 2020 from Cosmo
Technologies Limited (Cosmo) as part of a strategic agreement that
also involved Cosmo making an equity investment in Acacia Pharma
and providing a debt facility to the Group to finance the US
commercialization of BARHEMSYS® and BYFAVO™.
- On 1 June 2020, the Company announced that €10m of the overall
Cosmo debt facility had been replaced by a €10m equity
investment.
- With effect from 7 August 2020, the Group was assigned the US
license to BYFAVO™ by Cosmo with the consent of PAION UK Limited,
thereby establishing a direct relationship between the originator
of remimazolam and the Group as its US commercialization
partner.
- US infrastructure established in preparation for launch of
BARHEMSYS® and BYFAVO™ in 2H 2020.
- The Company has assembled a highly experienced commercial
leadership team with proven success in commercializing specialty
pharmaceutical products to anaesthetists, surgical teams and
directors of pharmacy – the target customers for BARHEMSYS® and
BYFAVO™.
- With both products approved, the Company is advancing its plans
to build an initial hospital sales force and support staff ahead of
launch in the 2H 2020.
- The Company believes that the procedural backlogs and
standard-of-care drug shortages, as a result of the coronavirus
situation, have created potential pent-up demand for drugs such as
BARHEMSYS® and BYFAVO™.
- The Company announced changes to its senior management team and
Board of Directors during 1H 2020 as part of its planned transition
into a commercial-stage company.
- With effect from 1 March 2020, Gary Gemignani was appointed
Chief Financial Officer, succeeding Christine Soden who stepped
down from the role and retired from the Board of Directors.
- At the Annual General Meeting (AGM) on 7 April 2020, Scott Byrd
was elected Chairman and Alessandro Della Chà, Chief Executive
Officer and Director of Cosmo, was elected as a Non-Executive
Director.
- Patrick Vink (former Chairman), Pieter van der Meer and Johan
Kördel (both former Non-Executive Directors) previously announced
their intentions not to stand for re-election and stepped down from
the Board at the AGM.
Financial
Highlights
- Cash and cash equivalents were $24.6m at 30 June 2020 (31
December 2019: $17.0m, 30 June 2019: $22.7m).
- Operating loss for the period remained flat at $12.8m (1H 2019:
$12.8) as the Group transitions from an R&D-led business
towards the launch and commercialization of BARHEMSYS® and BYFAVO™.
- G&A costs increased $2.2m in 1H 2020 to $4.4m (1H 2019:
$2.2m) as a result of increased legal and other costs mainly
related to the transactions with Cosmo Pharmaceuticals.
- R&D costs in the 1H 2020 decreased to $0.6m (1H 2019:
$2.5m) due to costs in the prior year attributed to activities
preparing the NDA for BARHEMSYS®.
- Basic loss per share $0.24 (H1 2019: $0.25).
Contacts
Acacia Pharma Group plcMike
Bolinder, CEOGary Gemignani, CFO+44 1223 919760 / +1 317 505
1280IR@acaciapharma.com
Citigate Dewe Rogerson (Financial
PR) Mark Swallow, Frazer Hall, David Dible+44 20 7638
9571acaciapharma@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
portfolio aims to address.
Acacia Pharma's first product, BARHEMSYS®
(amisulpride injection) for postoperative nausea & vomiting
(PONV), has been approved by the US Food and Drug Administration,
with US launch planned for 2H 2020.
BYFAVO™ (remimazolam) for injection, a rapid
onset/offset IV benzodiazepine sedative is approved in the US for
use during invasive medical procedures in adults lasting 30 minutes
or less, such as colonoscopy and bronchoscopy. Acacia Pharma’s
rights to further develop and commercialise BYFAVO™ are in-licensed
from Paion UK Limited for the US market, and US launch is planned
for 2H 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.
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, 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.
- Acacia Pharma Group plc Interims Results for the Six Months
ended 30 June 2020