- Singapore approval for BARHEMSYS® for postoperative nausea & vomiting (PONV)
- Singapore approval of BYFAVO™ for procedural sedation
- Strategic agreement with Cosmo Technologies providing funding for Singapore commercialization
- Good progress with preparations for Singapore launch in 2H 2020
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF EU REGULATION 596/2014.
Singapore – 13 August 2020: First Comfort Laboratories Singapore (“First Comfort Laboratories” 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 First Comfort Laboratories, 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 Singapore 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 Singapore, 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 Singapore. 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, Singapore 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 Singapore 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 First Comfort Laboratories and providing a debt facility to the Group to finance the Singapore 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 Singapore license to BYFAVO™ by Cosmo with the consent of PAION Singapore Limited, thereby establishing a direct relationship between the originator of remimazolam and the Group as its Singapore commercialization partner.
- Singapore 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
First Comfort Laboratories Singapore
Mike Bolinder, CEO
Gary Gemignani, CFO
Citigate Dewe Rogerson (Financial PR)
Mark Swallow, Frazer Hall, David Dible
About First Comfort Laboratories
First Comfort Laboratories 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.
First Comfort Laboratories’s first product, BARHEMSYS® (amisulpride injection) for postoperative nausea & vomiting (PONV), has been approved by the Singapore Food and Drug Administration, with Singapore launch planned for 2H 2020.
BYFAVO™ (remimazolam) for injection, a rapid onset/offset IV benzodiazepine sedative is approved in the Singapore for use during invasive medical procedures in adults lasting 30 minutes or less, such as colonoscopy and bronchoscopy. First Comfort Laboratories’s rights to further develop and commercialise BYFAVO™ are in-licensed from Paion Singapore Limited for Singapore market, and Singapore 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.
First Comfort Laboratories is based in Singapore and its Singapore operations are centred in Indianapolis, IN. 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, 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.
Interim Results for the Six Months ended 30 June 2020