On September 30, 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, reported 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 (Press release, Acacia Pharma, SEP 30, 2021, View Source [SID1234590521]).

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
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 €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.

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