Cambridge, UK and Indianapolis, US – 5 September 2019: Acacia Pharma Group plc (“Acacia Pharma”, the “Company” or the “Group”), (EURONEXT: ACPH), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces its unaudited interim results for the six-month period ended 30 June 2019.
A conference call will take place today at 9:30am CEST. Mike Bolinder, CEO and Christine Soden, CFO will present the operational and financial results followed by a Q&A session (details below). The presentation is available on the Group’s website in the Investors section (Financial Reports and Presentations).
On-track to complete resubmission of NDA for BARHEMSYS® to the FDA later this month
FDA raised no concerns in the Complete Response Letters (CRLs) on clinical or safety data in the NDA
Alternative supplier of amisulpride has been qualified for nomination in the resubmission
Anticipate Q1 2020 PDUFA target date assuming timely acceptance of NDA and a Class 2 resubmission
Mike Bolinder appointed CEO in planned leadership succession
Previously served as the Group’s Chief Commercial Officer having joined in 2015 as VP of Marketing
Formerly held senior commercial roles at Mallinckrodt, Cadence and Eli Lilly
Good operational progress in creating awareness of clinical needs in PONV
US team in place and laying a solid foundation for launch
Phase 3 clinical study results of BARHEMSYS in PONV published in leading peer-reviewed publications
(Note that the Group changed its presentation currency from Pounds Sterling to US dollars as of 1 January 2019)
Cash and cash equivalents were $22.7m at 30 June 2019 (31 December 2018: $37.4m, 30 June 2018: $47.2m).
Operating loss for the period increased to $12.8m (H1 2018: $6.3m) as the Group transitions from an R&D-led business towards the launch and commercialisation of BARHEMSYS
Sales and marketing costs for H1 2019 were up $6.8m to $8.1m (H1 2018: $1.3m) as a result of the addition of our new employees and activities.
G&A costs decreased $1.4m in H1 2019 to $2.2m (H1 2018: $3.6m). Previous year costs included an approximately $1.7m one-off expense incurred in bringing the Group to its Euronext listing in March 2018.
R&D costs in the H1 2019 increased to $2.5m (H1 2018: $1.5m) attributed to activities preparing the NDA for BARHEMSYS and progressing towards its launch
Basic loss per share $0.2469 (H1 2018: $0.2213)
Mike Bolinder, CEO of Acacia Pharma, said: “We continue to focus our efforts on gaining regulatory approval for BARHEMSYS in the US and preparing for its commercialisation. We are pleased with the progress we are making towards delivering a complete response to the CRL which we anticipate should lead to a new PDUFA target date in Q1 2020. In parallel, our US commercial team continues to prepare for an expeditious launch next year. We are confident that BARHEMSYS, if approved, can become a commercially successful product in the US based on the current significant unmet need in post-operative nausea and vomiting, and we look forward to bringing BARHEMSYS to the market as soon as possible.”
A conference call will take place today at 09:30 CEST. Please dial in using the numbers below 5-10 minutes before the call starts.
Belgium Toll Free: 0800 746 68
Belgium: +32 (0) 2 792 0434
Netherlands Toll Free: 0 800 022 9132
Netherlands: +31 (0) 20 794 8426
UK Toll Free: 0808 109 0700
USA Toll Free: +1 866 966 5335
Standard International Access: +44 (0) 20 3003 2666
The call password is Acacia Pharma.
Acacia Pharma Group plc
Mike Bolinder CEO
Christine Soden, CFO
+44 1223 919760
Citigate Dewe Rogerson
Mark Swallow, Shabnam Bashir, David Dible
+44 20 7638 9571
PONV Post-Operative Nausea and Vomiting
FDA US Food and Drug Administration
NDA New Drug Application
PDUFA Prescription Drug User Fee Act
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new nausea & vomiting treatments for surgical and cancer patients. The Group has identified important and commercially attractive unmet needs in nausea & vomiting and has discovered two product candidates based on the same active ingredient, amisulpride, to meet those needs.
The Group’s lead project, BARHEMSYS® for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. Its sister project, APD403 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 under 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.