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
-- Barhemsys(R) and Byfavo(R) launches continue to show strong progress
gaining formulary access in 107 additional accounts over the past 3
months
-- For Barhemsys -- 260 accounts on formulary with >80% win rate to date and
well on track to meet annual formulary goal (300 accounts) by year end
-- For Byfavo -- 95 accounts on formulary with >90% win rate to date, and on
track to meet our annual formulary goal (150 accounts) by year end
Cambridge, UK and Indianapolis, US -- 30 September 2021: 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 six month period ended 30 June 2021
and provides an update on the commercial progress of Barhemsys(R)
and Byfavo(R) in the United States.
A presentation of interim results by Acacia Pharma's senior
management team will be webcast (listen only) live later today 30
September at 14.00 CEST (08.00 EST) and participants can register
by
https://www.globenewswire.com/Tracker?data=HbSIdss23SQBi7hqBv9ER2Yy-P-taIEE5lklgKyuWaTbaPV7g4zN8wgYt3OPehLDZtuma0qbEGKE15U5vrteQdJOf0P4mf2G8dKE-5rjzIwfi3jxWPL--UGEHSEk1PcaBydBu890nxOmgRquP-ac6g==
clicking here or from
https://www.globenewswire.com/Tracker?data=g1NXs34jkFd_5FZrA97zGvNCn6yi8l4MP0U5Z1gFSDkXBIKAanMIzF6Qd_2VcYDr-cwSzYygpbjj17mFcO_uHj3jTzUzaQ_fIAARTK7Seno=
www.acaciapharma.com. A replay will be available after the event at
the same link.
International conference call dial-in details are noted below
with callers able to participate in a Q&A.
The results report will be available at
https://www.globenewswire.com/Tracker?data=g1NXs34jkFd_5FZrA97zGvNCn6yi8l4MP0U5Z1gFSDkPNuxTi-8YYK-fggxuG_fwDk-3Rptoh5GT9t86SCi8Aio6-pKtlQxGUuJy0PWFuhM=
www.acaciapharma.com in the Investors section from 07.00 CEST today
and the presentation will be made available before the start of the
call.
As previously announced, Acacia will also hold a KOL webinar
later today at 18.00 CEST/12.00 EDT to discuss the hospital user
experience with Barhemsys and Byfavo. Advanced registration is
required, and details can be found on our website under the
Media/Events section.
Commenting on the results, Mike Bolinder, Chief Executive
Officer, said: "We continue to make significant progress towards
becoming a leading US hospital pharmaceutical company. During the
first half, our team has done an exceptional job executing on our
corporate objectives, despite the challenging operating environment
posed by the global pandemic. The commercial launches of both
Barhemsys and Byfavo are making excellent progress in terms of
formulary access, the most important measure of success in this
early phase of their commercialization. Given this strong
performance, we remain on track to meet our annual formulary goals
for both products.
"One key early indicator of the sales potential of both products
is the overwhelmingly positive feedback we have received from
customers about their initial experiences. They have been very
impressed at how rapidly both drugs have been able to improve their
care for patients.
"We continue to experience high levels of engagement and support
from Key Opinion Leaders and many of the largest academic
institutions across the country. We have already begun the
pediatric study for Byfavo at study sites in some of the most
well-known and respected pediatric centers in the U.S.
"With Barhemsys, we are planning to initiate our Phase 4 PROMPT
study, which is designed to gather real-world evidence on the
benefits of using the drug. We believe this study can help quantify
and document the difference Barhemsys makes in the real-world
setting which will provide further important data to support our
marketing efforts. We are also very pleased to report that the
Marketing Authorization Application (MAA) for Barhemsys has been
submitted, validated and is now under formal review in major
European markets and we are working diligently to progress
international licensing agreements ahead of the product's
anticipated European approval in 2022.
"Lastly, we have continued to make strong progress at the
corporate level. We raised EUR27m (c$33m) in February, made an
early repayment of the outstanding Hercules loan facility thereby
lowering our borrowing costs and continue to tightly manage our
cash burn. Additionally, we were very excited to have appointed Deb
Hussain as our new Chief Commercial Officer who brings tremendous
knowledge and experience to the organization."
Operating Highlights for First Half 2021
-- Barhemsys and Byfavo launches continue to track well despite the
challenging operating environment caused by the global pandemic
--
-- Barhemsys (amisulpride injection)
-- Sales team began customer engagement in October 2020
-- To date, 260 accounts on formulary with >80% win rate
-- Well on track to meet our formulary goal (300 accounts) by
year end despite continued COVID-19 related access
restrictions
-- Partnering with key institutions to begin the Barhemsys
PROMPT study to gather real-world evidence
-- MAA submitted, validated and now under formal review in
major European markets
--
-- Byfavo (remimazolam injection)
-- Launched in the U.S. at the end of January 2021
-- To date, 95 accounts on formulary with >90% win rate
-- On track to meet our formulary goal (150 accounts) by year
end
-- Byfavo pediatric study initiated
-- Commercial traction for both products continues to be strong
-- Positive feedback from customers on initial experience with Byfavo
and Barhemsys
-- Engagement with KOLs and key institutions remains high
-- Phase 4 studies being initiated to expand usage
-- Significant addressable markets for both products
-- Appointment of new Chief Commercial Officer
-- Deb Hussain joined as Chief Commercial Officer in May 2021 after
having spent over 20 years at Eli Lilly and Company, where she led
some of the largest and most successful brands in the industry and
had profit and loss responsibility for over $2 billion of revenue.
Financial Highlights
Results are presented in US$, reflecting the currency of the
majority of expected costs and revenues
-- Equity financing of EUR27m (c$33m) completed in February 2021. Early
repayment of Hercules loan completed in May 2021
-- Cash and cash equivalents were $47.1m at 30 June 2021 (30 June 2020:
$24.6m, 31 December 2020: $46.7m)
-- Net revenue for the first half of 2021 was $0.4m (1H 2020: $0.0m)
-- Operating loss for the period was $24.9m (1H 2020: $12.8m) as the Group
has invested in the launch and commercialization of Barhemsys and Byfavo
--
-- G&A costs increased $4.1m in 1H 2021 to $8.5m (1H 2020: $4.4m)
mainly as a result of the amortization of the Byfavo license
($4.1m)
-- R&D activities have been focused on meeting FDA post-marketing
commitments for both Barhemsys and Byfavo. R&D costs in the first
half of 2021 increased to $2.1m (1H 2020: $0.6m) as the
development activities in relation to our post-marketing
commitments were initiated
-- Basic loss per share for the first half of 2021 was $0.31 (H1 2020:
$0.24) reflecting greater commercial spend and incorporating an increase
of 24.8 million shares following the equity raises in August 2020 and
February 2021 (1H 2021: 88.7 million average shares outstanding; 1H 2020:
63.9 million average shares outstsanding).
Summary and Outlook for 2021
Acacia Pharma is on track to meet its formulary goals for both
Barhemsys and Byfavo for the full year 2021 and the Company has
been very encouraged by the positive user feedback received for
both products.
The markets being addressed initially are large and the Company
is confident that these products will successfully address the
current unmet needs in PONV and procedural sedation. A series of
Phase 4 studies is now being initiated to provide further impetus
and data to expand into additional market segments for both
Barhemsys and Byfavo over the longer term.
Furthermore, with the highly experienced team put in place and
the strong early foundation being built for Barhemsys and Byfavo
through formulary access, we believe Acacia Pharma is well
positioned to deliver significant commercial success in the
future.
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 Stavelot: 0800 746 68
Netherlands Toll Free: 0 800 022 9132
UK-Wide: +44 (0) 33 0551 0200
UK Toll Free: 0808 109 0700
New York USA: +1 212 999 6659
USA Toll Free: 1 866 966 5335
Password: Acacia Pharma
Contacts
Acacia Pharma Group plc International Media
Mike Bolinder, CEO Frazer Hall, Mark Swallow, David
Gary Gemignani, CFO Dible
+44 1223 919760 / +1 317 505 1280 Citigate Dewe Rogerson
mailto:IR@acaciapharma.com IR@acaciapharma.com +44 20 7638 9571
mailto:acaciapharma@citigatedewerogerson.com
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 mailto:chrisvanraemdonck@telenet.be
mailto:ikoffler@lifesciadvisors.com 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(R) (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
-- HY 2021 results report
https://ml-eu.globenewswire.com/Resource/Download/3ecc5741-5f01-4e53-b963-8c9555d18555
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