HONG KONG SAR – Media consciousness – March 22, 2021 – The Board of Administrators of the Firm is happy to announce the audited consolidated annual outcomes of the Group for the fiscal yr ended December 31, 2020, in addition to the comparative figures for the fiscal yr ended December 31, 2019 as following. These consolidated monetary statements of the Group for the reporting interval have been reviewed by the audit committee and audited by the auditors of the corporate, Deloitte Touche Tohmatsu.
On this announcement, “we”, “our” and “our” seek advice from the Firm and, the place the context requires, the Group. Sure quantities and percentages included on this announcement have been topic to rounding changes or have been rounded to 1 or two decimal locations. Any discrepancy in a desk, graph or elsewhere between the totals and the sums of the quantities proven therein is because of rounding.
Throughout the reporting interval, we elevated our pharmaceutical belongings to 17 in our product portfolio with full protection for illnesses of the back and front of the eyes. In comparison with having just one Section III scientific trial on the time of our enrollment, thus far we’ve got moreover initiated 5 Section III scientific leads for our related drug candidates and have six scientific trials of section III in progress in whole. Our drug candidates goal varied areas of ophthalmology that require pressing medical therapy, together with uveitis, childhood myopia, conjunctivitis, glaucoma and moist age-related macular degeneration. Our important progress in Section III scientific trials additionally makes us a number one revolutionary ophthalmic drug firm in China when it comes to the variety of revolutionary ophthalmic medicine at the moment in Section III scientific trials registered with the CDE.
Throughout the reporting interval, the Hainan Provincial Drug Administration listed OT-401 (fluocinolone intravitreal implant), our base product and one in all our major drug candidates, within the checklist of pilot research applications for medicine in the actual world (藥 This is likely one of the first batches of prescribed drugs to be included within the RWS pilot applications. Consequently, progress within the commercialization of OT-401 ought to be accelerated.
As of the date of this announcement, we’ve got began a Section III scientific trial for OT-101, our self-developed low-strength atropine, in the US. We plan to use for a multi-regional section III scientific trial in China and Europe for OT-101, which is predicted to be the primary worldwide multi-regional section III scientific trial for low-strength atropine or its related prescribed drugs comprising Chinese language. inhabitants.
Throughout the reporting interval, we actively promoted OT-401, brimonidine tartrate eye drops, Ou Qin and Kangshu (康 姝), and achieved a complete turnover of RMB 13.1 million, rising annual revenue of 6792.6%, whereas our gross revenue margin was 86.8% for a similar yr. In January 2021, the month-to-month gross sales quantity reached about 5 million RMB (unaudited). Our compound quarter-over-quarter progress charge is roughly 215.5% because the launch of our first drug.
As of December 31, 2020, we had 69 workers in our gross sales and advertising staff with protection of 267 hospitals nationwide, of which 53 are grade III hospitals. Our firm primarily arrange knowledgeable promotion staff with in depth expertise protecting the home ophthalmology market, which additional helps our firm’s marketed merchandise to enter the hospital market shortly.
As of the date of this announcement, building of our manufacturing website in Suzhou is nearing completion. With an anticipated annual manufacturing capability of 455 million doses, our Suzhou manufacturing website is predicted to start pilot manufacturing in September 2021 with the aim of additional decreasing product value and growing gross sales revenue margin.
We recorded an adjusted loss and whole mixture expense of RMB 276.7 million for the fiscal yr ended December 31, 2020, a rise of RMB 194.3 million in comparison with RMB 82.4 million for the fiscal yr ended December 31, 2019, primarily attributable to registration charges. of RMB 41.1 million in addition to elevated gross sales and advertising prices to determine our advertising infrastructure.
This adjusted loss is obtained by deducting the IFRS loss and whole mixture bills of RMB 2264.9 million (2019: RMB 1325.5 million) from (i) a non-recurring loss, non-cash, adjusted to truthful worth IFRS of 1694.5 RMB. million euros for our pre-IPO most popular shares, which have been then transformed to shares upon itemizing, and (ii) share-based cost charges of RMB 293.6 million.
Our whole income was 13.1 million RMB for the fiscal yr ended December 31, 2020, a major improve from 0.2 million RMB for the fiscal yr ended December 31, 2019, primarily attributable to earnings generated by the advertising and advertising of Ou Qin and brimonidine. tartrate eye drops along with income generated from gross sales of OT-401 beneath the Boao pilot program. For the fiscal yr ended December 31, 2020, the typical quarterly progress charge of our whole income was 215.5%, regardless of the influence of COVID-19.
Our gross revenue margin, which was 86.8% for the yr ended December 31, 2020, decreased barely from 94.7% for the yr ended December 31, 2019. That is primarily because of diversification of our product combine and was partially offset by a discount in the price of the present product.
Our analysis and growth prices and capitalized growth prices amounted to RMB 355.4 million for the yr ended December 31, 2020, a rise of 257% from RMB 99.5 million for the yr ended December 31, 2020. fiscal yr ended December 31, 2019. real-world research for OT 401 and several other pivotal Section III scientific trials of our drug candidates, together with OT-401, OT-101, OT-702, OT-1001 and OT-301, in addition to the elevated analysis wants of our different drug candidates.
As of December 31, 2020, we had roughly 2,051.8 million RMB in financial institution balances and money, which doesn’t embrace the gross proceeds of HK $ 793.8 million from the extra subscription of recent Shares made by our firm. in January 2021.
We’re a China-based ophthalmic pharmaceutical platform firm devoted to the identification, growth and commercialization of first-rate or premier ophthalmic therapies. Our imaginative and prescient is to supply a complete, world-class pharmaceutical answer to satisfy the numerous unmet ophthalmic medical wants in China. We consider our platform positions us properly to develop into the chief in ophthalmology in China, with a first-come benefit over future rivals. By leveraging our platforms, we’ve got constructed a strategically designed, complete, revolutionary and validated ophthalmic drug portfolio. Up to now, we had 17 lively prescribed drugs in our portfolio, protecting all main illnesses of the back and front of the attention. We’ve 5 key drug candidates in Section III scientific growth, which we consider will probably be first or best-in-class if accepted and have important near-term income potential as early as 2022. Our portfolio of merchandise contains three of the ten ophthalmic medicine accepted by the FDA since 2015 that aren’t but out there in China in any formulation. As well as, our product portfolio contains three medicine which might be in the marketplace or within the technique of being marketed.