Significant Milestones Achieved on the Commercialisation of Fortacin™ and Business Expansion
HONG KONG, Aug. 30, 2021 /PRNewswire/ — Endurance RP Limited ("Endurance Longevity" or the "Company" and together with its subsidiaries, the "Group"; stock code: 0575.HK), a Hong Kong-based investment company specializing in growth and value-led investments in the healthcare and late-stage life science sector, is pleased to announce the unaudited consolidated interim results for the 6 months ended 30 June 2021 ("Reviewing Period").
Key Financial Highlights
As at 30 June 2021,
- Profit attributable to the shareholders of the Company was approximately US$2.66 million (2020: loss of approximately US$27.16 million).
- Shareholders’ equity increased by 6.27% to approximately US$53.46 million (31 December 2020: US$50.31 million)
The Group reported a profit of approximately US$2.66 million which was mainly attributable to: (i) an unrealised marked-to-market gain in respect of the Company’s equity portfolio of FAFVPL of approximately US$12.18 million; (ii) a milestone payment of US$3.20 million, and (iii) an unrealised gain in respect of the Company’s derivatives of approximately US$3.05 million; while being offset somewhat by: (iv) an amortisation charge of approximately US$11.15 million on the intangible assets, being non-cash items; and (v) the Group’s operating expenses of approximately US$5.38 million.
Shareholders’ equity increased to approximately US$53.46 million, an increase of approximately 6.27% as compared with that at 31 December 2020, with the increase being mainly attributable to the profit attributable to shareholders of the Company. As at 30 June 2021, the Group had approximately US$16.10 million in cash and listed securities and the gearing ratio (being long-term debts over total equity and long-term debts) was approximately 20.19% (31 December 2020: 21.23%).
The Group received US$2.88 million net of PRC withholding tax from Wanbang Biopharmaceutical, the Company’s commercial strategic partner for China in respect of obtaining clinical trial approval for Senstendä (the marketing name of Fortacinä in Mainland China) from the Centre of Drug Evaluation (CDE) in China on 5 February 2021.
Significant Progress in Healthcare and Life Sciences Businesses
The Group’s healthcare, life sciences and wellness investments are far less sensitive to macro-economic fundamentals and fluctuations and remain its core focus. Despite the difficulties presented by the COVID-19 pandemic, the Group remained active in strengthening its relationships and continuing its negotiations with potential commercial partners and stakeholders on our investment projects.
The Group has appointed a leading global marketing consulting firm to conduct comprehensive analysis of patients, physicians, and healthcare providers on their willingness to cover and level of price sensitivity for coverage for Fortacin™ across the US. The survey has confirmed that a price of US$90 to US$150 is sustainable for the proposed US presentation of Fortacin™. Further, the target product profile would result in over 80% being prepared to consider Fortacin™ as an effective treatment, an outstanding result. In respect of the US Phase II validation study, the clinical research organisation has successfully completed the prespecified data analysis from the 16 sites undertaken to validate the FDA mandated patient reported outcome (the "PRO") for premature ejaculation. Overall, the study confirms the safety and efficacy of Fortacin™. The new data will be used to refine the final Phase III RCT protocol, which is already prepared, and suitable clinical sites screen for expedient and good clinical practice enrolment. The Group anticipates submitting the study to the FDA by the end of August 2021 as another big step in commercialising Fortacin™ in the US. The Group is currently securing a partner just ahead of or while the Group conducts the Phase III trial.
Meanwhile, Senstend™ obtained clinical trial approval from the CDE on 5 February 2021. Wanbang Biopharmaceutical will now focus its efforts with assistance from the Group towards commencement of the RCT in China. Wanbang Biopharmaceutical will commence manufacturing clinical supplies (both active and placebo) in late August 2021 from PSNW. The commercial scale up to increase the current batch size per each manufacturing run to 50,000 units from 15,000 units will now commence in September 2021 after the latest commercial batch has been manufactured in August 2021. Wanbang Biopharmaceutical has appointed a leading contract research organisation to undertake the phase III double blinded multi-centre RCT and the Group looks forward to undertaking this next critical step towards commercialisation of Senstend™ in China.
Orient EuroPharma has launched Fortacin™ in Hong Kong and Macau with limited supply as it will now not receive its full launch compliment until September 2021. Official launch of Fortacin™ in Taiwan will be in September 2021. In terms of other out-licensing opportunities, the Company is in discussions with its commercial strategic partners for the Middle East, India, North America and Latin America (LATAM) region.
The Group has continued to implement and integrate the acquisition of Deep Longevity, Inc (DLI), which completed in December 2020, which will serve as a key platform for the Group’s expansion into the health and wellness sector. During the Reviewing Period, a core focus has been on DLI’s three main business segments, being: (i) Direct to Consumer through its Young.AI app providing biological, behavioural, and psychological aging clock tracking and recommendations designed to slow down or reverse biological aging. DLI is also constantly developing and patenting new aging clocks utilising new data types; (ii) the provision of its AgeMetric™ biological age reports to clinics and medical doctors for a fee; and (iii) providing age prediction and recommendation services via software as a service (SaaS) AI and on-premises instalment to the life and health insurance companies.
Jamie Gibson, Chief Executive Officer of the Company commented, "We are excited to announce our first interim results under our new entity. We were able to perform strongly through to 30 June 2021 while operating in a difficult environment due to COVID-19, achieving a number of significant milestones. With our streamlined focus, sensible capital structure and redefined market position, we remain optimistic about the future prospects for the Group and its shareholders and will: (i) continue to pursue the successful commercialisation of Fortacin™ / Senstend™ as quickly as possible, with the Over-the-Counter (OTC) roll-out continuing, as well as in the remaining key markets of the US, China, Asia, Latin America and the Middle East; (ii) commercialise DLI’s Young.AI mobile App and the Young.AI website, together with partnering with clinics, laboratories and insurance companies by offering its AgeMetric™ reports and access to its online platform; (iii) continue monitoring its investments in Venturex and West China; and (iv) continue with its existing strategy of pursuing strategic and value-led investments in the healthcare and life sciences sectors."
About Endurance RP Limited (Stock code: 0575.HK)
Endurance Longevity is a diversified investment group based in Hong Kong currently holding various corporate and strategic investments focusing on the healthcare, wellness and life sciences sectors. The Group has a strong track record of investments and has returned approximately US$298 million to shareholders in the 24 years of financial reporting since its initial public offering in May 1997.
The English version of this press release shall prevail in case of any discrepancy or inconsistency between English version and its Chinese translation.
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