Specialty pharmaceutical company iX Biopharma Ltd (“iX Biopharma” or “the Group”) had a very productive year and capped off its financial year ended 30 June 2018 (“FY18”) by achieving several major milestones in its pharmaceutical and nutraceutical businesses.
Singapore, 27 August 2018 – Specialty pharmaceutical company iX Biopharma Ltd.(“iX Biopharma” or “the Group”) had a very productive year and capped off its financial year ended 30 June 2018 (“FY18”) by achieving several major milestones in its pharmaceutical and nutraceutical businesses.
The Group received regulatory approval in Australia for Wafesil, its sublingual (under the tongue) sildenafil product for the treatment of male erectile dysfunction. This makes Wafesil the first sublingual sildenafil product in Australia to receive regulatory approval. It is also iX Biopharma’s maiden pharmaceutical product utilising WaferiX, its proprietary sublingual wafer formulation, to reach approval and registration. WaferiX allows sildenafil to be administered safely, conveniently and rapidly into the blood stream. The approval of Wafesil affirms the utility of WaferiX and demonstrates the Group’s ability to bring products from clinical development to registration and launch.
Following closely on its heels, the Group also secured approval and registration for Silcap, a sildenafil drug in a novel capsule form, in August 2018. Silcap is the first sildenafil capsule to be approved in Australia. Silcap and Wafesil will compete in the growing generic male erectile dysfunction market as alternatives for patients who dislike or are unable to swallow tablets.
In FY18, the Group conducted Phase 2 randomised double-blind placebo-controlled multi-dose efficacy clinical studies (“KET010”) for Wafermine, its lead pain management product, to determine the drug’s efficacy in bony and soft tissue surgical pain models. Recruitment and dosing of 125 patients were successfully completed in July 2018 with top-line results of the KET010 studies expected in September 2018.
iX Biopharma enjoyed some early success from the soft launch of its nutraceuticals brand, Entity Health, in Australia in April 2018. As at June 2018, the Group has expanded its sales reach to 25 pharmacy retailers in bustling cosmopolitan locations across Australia, from 15 stores during its initial launch. Notably, LumeniX, its proprietary skin-brightening formula, and LiviUp, a hangover supplement, received acclaim from healthcare professionals in Australia. In the year ahead, marketing initiatives will be stepped up in Australia as the Group works to expand the number of pharmacy retail outlets stocking Entity products.
FY18 saw the Group transition from a substantially R&D-based organisation to encompass production and revenue generation. In preparation for wider commercialisation of the Group’s pharmaceutical and nutraceutical products, the Group increased its headcounts to scale up manufacturing capacity and regulatory support. The Group will continue to build up its production planning and logistical capabilities ahead of a wider, nationwide official launch of Entity Health to the Australian public in the ensuing months.
The Group closed the financial year with revenue of $6.5 million, compared to $6.4 million in the preceding year (“FY17”). Revenue was mainly from the laboratory testing services and included revenue from its Entity Health brand and the supply of its pain management drugs, Wafermine and BnoX, to hospitals in Australia under the Special Access Scheme exemption set out in Schedule 5A of the Therapeutic Goods Regulations. The Group recorded a net loss of $15.1 million in FY18, compared to $7.4 million in FY17. This took into account higher R&D expenses of $3.6 million due to higher expenditure of $2.9 million on Wafermine KET010 studies and a decrease of $0.7 million in R&D rebates, a net negative effect of currency exchange movements of $2.1 million and an increase of $1.1 million in manufacturing expenses as the Group scaled up its manufacturing capacity in preparation for commercial production. Building on the foundations laid in FY18, the Group is well-positioned to benefit from strong growth following the shift of its operating model from drug development to encompass commercialisation and income generation.
About iX Biopharma Ltd
iX Biopharma is a Singapore public-listed specialty pharmaceutical and nutraceutical company, operating a fully integrated business model from drug development to laboratory testing, manufacturing and supply, with facilities in Australia. The Group is focused on the development and commercialisation of innovative therapies for improving the quality of life of those suffering from pain and other health conditions.
iX Biopharma’s pipeline of products under development includes Wafermine (ketamine wafer) and BnoX (buprenorphine wafer) for pain management. iX Biopharma’s drugs for the treatment of erectile dysfunction, Wafesil, a sublingual sildenafil wafer, and Silcap, have been registered in Australia.
The Group’s nutraceuticals division, Entity Health Limited, recently launched its Entity line of nutraceutical products and is engaged in the development and commercialisation of nutraceutical products that address specific conditions and improve quality of life. In addition to the successful registration of Wafesil and Silcap, the Group’s nutraceutical arm, Entity Health, has also applied for assessment by TGA for quality and safety of its nutraceutical products. To date, the Group has successfully obtained 15 product listings on the ARTG with 8 listings for domestic sales and 7 listings for export sales on the ARTG.
Contact for media: Dr Janakan Krishnarajah Chief Medical Officer, iX Biopharma T: +65 6235 2270 E: j.krishnarajah@ixbiopharma.com
Alvina Tan T: +65 6221 0081 M: +65 9787 7267 E: alvina.tan@arkadvisors.com.sg
Eva Tan Commercial Director, iX Biopharma T: +65 6235 3212 E: eva.tan@ixbiopharma.com
Karin Lai T: +65 6221 0081 M: +65 9837 8136 E: karin.lai@arkadvisors.com.sg
This document has been prepared by the Company and its contents have been reviewed by the Company's sponsor, CIMB Bank Berhad, Singapore Branch (the “Sponsor”), for compliance with the relevant rules of the SGX-ST Listing Manual Section B: Rules of Catalist. The Sponsor has not verified the contents of this document. This document has not been examined or approved by the SGX-ST. The Sponsor and the SGX-ST assume no responsibility for the contents of this document, including the accuracy, completeness or correctness of any of the information, statements or opinions made or reports contained in this document. The contact person for the Sponsor is Mr Yee Chia Hsing, Head, Catalist. The contact particulars are 50 Raffles Place, #09-01 Singapore Land Tower, Singapore 048623, telephone: (65) 6337- 5115.
