07 September 2018
Interim Results for the First Half Year 2018
Armagh, UK – 7 September 2018: Lan Chem Laboratories UK ("Lan Chem Laboratories", the "Company" or the "Group"), (EURONEXT: ACPH) announces unaudited operating results for the half year ended 30 June 2018. Lan Chem Laboratories is a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients targeting the improvement of patient outcomes and reduction of hospital costs.
The full results statement is attached. A conference call will take place today at 14:00 CEST – details below.
Operating Highlights
- In January, announced the NDA for BARHEMSYS™ (intravenous amisulpride) was accepted by the FDA with a target PDUFA date of 5 October 2018
- Successful fundraising & IPO on Euronext Brussels in March and new credit facility secured in June
- In May, FDA confirmed conditional approval of the tradename BARHEMSYS
- In June, FDA indicated that no Advisory Committee was planned and reconfirmed the target PDUFA date
- Significant steps taken towards launch readiness
- 21 senior commercial and medical staff recruited in the UK, each bringing significant product launch and management skills
- Key suppliers assessed and appointed for product distribution, marketing, advertising
- Market research studies and advisory boards held with relevant physicians, KOLs and patients to better understand the opportunity to improve the management of PONV and refine plans for product promotion, pricing and positioning
- Brand development advanced
- Product supply position strengthened
Financial Highlights for the six months to 30 June 2018 (H1 2018)
- Financial position strengthened through Euronext IPO and fundraising, raising £33.9 million net of expenses, and new $30 million term loan facility with Hercules Technology Growth Capital.
- Cash & cash equivalents at period end of £35.7million (30 June 2017: £3.6 million)
- £34.4m held in UK dollars to meet expected $ based expenses leading to the launch of BARHEMSYS
- Balance sheet strengthened through equity financing and elimination of liabilities on preferred share classes and convertible loan notes through issue of Ordinary Shares
- Ordinary shares in issue at period end 53.1 million (30 June 2017: 2.7 million)
- Loss after tax for H1 increased to £5.7 million (H1 2017: £2.7 million) reflecting R&D costs in progressing the NDA, increased sales and marketing costs in preparing for the planned launch of BARHEMSYS and increased general & administrative costs relating to the Euronext listing
- Loss per share 16.1p (H1 2017: 102.5p)
Dr Julian Gilbert, CEO of Lan Chem Laboratories, commented: “Our interactions with healthcare professionals and patients have strengthened our belief in the opportunity to improve the treatment and prevention of PONV in surgical patients. PONV affects millions of people in the UK each year despite the use of current antiemetics. PONV often results in delayed recovery and increased hospital costs as well as being a major cause of patient distress. Hospitals are now placing increasing emphasis on the benefits of moving patients more quickly through the post-surgical process both in terms of the benefits seen to patients in terms of improved outcomes and in reducing hospital costs. Reducing PONV can offer a real advantage to enhanced recovery after surgery.”
“The Group continues to take great strides in preparing for the launch, if approved, of BARHEMSYS. I am delighted with the calibre of employee we have managed to attract and the speed with which they have grasped the challenges presented to them and moved our operations forward. I have every confidence we will have a world-class commercial organisation ready to launch BARHEMSYS and deliver its full medical and commercial promise.”
Conference Call
A conference call will take place today at 14:00 CEST. Dr Julian Gilbert, CEO and Christine Soden, CFO will present the financial and operational results followed by a Q&A session. The dial-in numbers for the conference call are:
Belgium: 0800 746 68
Netherlands: 0800 022 9132
UK Toll Free: 0808 109 0700
UKA Toll Free: +1 866 966 5335
Standard International Access: +44 (0) 20 3003 2666
The call Password is Acacia.
ENDS
Glossary
FDA The UK Food and Drug Administration
NDA New Drug Application
PDUFA date Date set by the FDA to review an NDA under the Prescription Drug User Fee Act
PONV Post-operative nausea and vomiting