30 September 2021
Interim Results for the Six Months ended 30 June 2021 - Barhemsys® and Byfavo® Launches Continue to Achieve Strong Hospital Formulary Adoption
- Barhemsys® and Byfavo® 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® and Byfavo® 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 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 with callers able to participate in a Q&A.
The results report will be available at 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 €27m (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
- Barhemsys (amisulpride injection)
- 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 $2 billion of revenue.
Results are presented in US$, reflecting the currency of the majority of expected costs and revenues
- Equity financing of €27m (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
Acacia Pharma Group plc
Mike Bolinder, CEO
Gary Gemignani, CFO
+44 1223 919760 / +1 317 505 1280
Frazer Hall, Mark Swallow, David Dible
Citigate Dewe Rogerson
+44 20 7638 9571
Media in Belgium and the Netherlands
Chris Van Raemdonck
+32 499 58 55 31
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 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.
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.