HONG KONG SAR – Media OutReach – 22 March 2021 – The Board of Directors of the Company is pleased to announce the audited consolidated annual results of the Group for the year ended December 31, 2020, together with the comparative figures for year ended December 31, 2019 as follows. These consolidated financial statements of the Group for the Reporting Period have been reviewed by the Audit Committee and audited by the Company’s auditors, Deloitte Touche Tohmatsu.
In this announcement, “we”, “us” and “our” refer to the Company and where the context otherwise requires, the Group. Certain amounts and percentage figures included in this announcement have been subject to rounding adjustments, or have been rounded to one or two decimal places. Any discrepancies in any table, chart or elsewhere between totals and sums of amounts listed therein are due to rounding.
During the Reporting Period, we have increased our drug assets to 17 in our product portfolio with full coverage of front-of-the-eye and back-of-the-eye diseases. Comparing to having only one phase III clinical trial at the time of our Listing, to date, we have further initiated five phase III clinical trails for our relevant drug candidates, and have six ongoing phase III clinical trials in aggregate. Our drug candidates target various ophthalmology fields which require urgent medical treatment, including uveitis, myopia in children, conjunctivitis, glaucoma and wet age-related macular degeneration. Our significant progress in phase III clinical trials also make us a leading company in terms of ophthalmic innovative drugs in China in terms of the number of innovative opthalmic drugs currently in phase III clinical trials registered with CDE.
During the Reporting Period, Hainan Provincial Drug Administration listed OT-401 (fluocinolone intravitreal implant), our Core Product and one of our key drug candidates, in the list of drug real-world study pilot programs (藥品真實世界研究試點名單). It is one of the first batch of pharmaceuticals that have been included drugs in RWS pilot programs. As a result, the commercialization progress of OT-401 is expected to be accelerated.
As of the date of this announcement, we have commenced a phase III clinical trial for OT-101, our self-developed low-concentration atropine, in the United States. We are planning to apply for a multi-regional phase III clinical trial in China and Europe for OT-101, which is expected to be the first international multi-regional phase III clinical trial for low-concentration atropine or its similar pharmaceuticals that includes Chinese population.
During the Reporting Period, we actively promoted OT-401, brimonidine tartrate eye drop, Ou Qin and Kangshu (康姝) and achieved a total sales revenue amounted to RMB13.1 million, representing a year-on-year growth of 6,792.6%, while our gross profit margin was 86.8% for the same year. In January 2021, the amount of monthly sales have reached approximately RMB5.0 million (unaudited). Our quarter-on-quarter compound growth rate is approximately 215.5% since the commercialization of our first drug.
As of December 31, 2020, we had 69 employees in our sales and marketing team with coverage of 267 hospitals nationwide, among which, 53 are Grade III hospitals. Our Company has primarily established a professional promotion team with extensive experience covering nationwide ophthalmology market, which further assists our Company’s commercialized products to penetrate into the hospital market in a swift manner.
As of the date of this announcement, the construction of our Suzhou manufacture site is close to completion. With a designed annual production capacity of 455 million doses, our Suzhou manufacture site is expected to commence pilot production in September 2021 with an aim to further lower product cost and increase sales profit margin.
We recorded adjusted loss and total comprehensive expenses of RMB276.7 million for the year ended December 31, 2020, representing an increase of RMB194.3 million from RMB82.4 million for the year ended December 31, 2019, primarily attributable to the listing expenses of RMB41.1 million as well as an increase in selling and marketing expenses establishing our commercialization infrastructure.
This adjusted loss is arrived at by deducting the IFRS loss and total comprehensive expenses of RMB2,264.9 million (2019: RMB1,325.5 million) from (i) an one-time, non-cash, IFRS fair value adjustments loss of RMB1,694.5 million for our pre-IPO preferred shares, which was subsequently converted to Shares upon Listing, and (ii) the share-based payment expenses of RMB293.6 million.
Our total revenue was RMB13.1 million for the year ended December 31, 2020, representing a significant increase from RMB0.2 million for year ended December 31, 2019, primarily attributable to the revenue generated from the commercialization and marketing of Ou Qin and brimonidine tartrate eye drop in addition to the revenue generated from the sales of OT-401 under the Boao Pilot Program. For the year ended December 31, 2020, our total revenue average quarterly growth rate was 215.5%, despite the impact of COVID-19.
Our gross profit margin, which was 86.8% for the year ended December 31, 2020, slightly decreased as compared with 94.7% for the year ended December 31, 2019. This was primarily due to the diversification of our product mix and was partly offset by lowered cost of existing product.
Our research and development expenses and capitalized development cost amount to RMB355.4 million for the year ended December 31, 2020 representing an increase of 257% from RMB99.5 million for the year ended December 31, 2019. The spending was mainly incurred from the real world study for OT 401 and multiple pivotal phase III clinical trial of our drug candidates, including OT-401, OT-101, OT-702, OT-1001, and OT-301, as well as the increased research needs of our other drug candidates.
As of December 31, 2020, we had approximately RMB2,051.8 million in bank balances and cash, which does not include the gross proceeds of HK$793.8 million from the top-up subscription of new Shares conducted by our Company in January 2021.
We are a China-based ophthalmic pharmaceutical platform company dedicated to identifying, developing and commercializing first- or best-in-class ophthalmic therapies. Our vision is to provide a world-class pharmaceutical total solution to address significant unmet ophthalmic medical needs in China. We believe our platform positions us well to achieve leadership in China ophthalmology, with a first-mover advantage over future competitors. Leveraging our platforms, we have built a strategically designed ophthalmic drug portfolio that is comprehensive, innovative and validated. To date, we had 17 drug assets in our portfolio, covering all major front- and back-of-the-eye diseases. We have five key drug candidates in phase III clinical development stage, which we believe will potentially be first- or best-in-class if approved and have significant near-term revenue potential from as early as 2022. Our product portfolio includes three of the ten ophthalmic drugs approved by the FDA since 2015 that are not yet available in China in any formulation. Additionally, our product portfolio includes three drugs that are in or near the commercial stage.