Media
\nOutReach<\/a>\u00a0– 22 March 2021 – The Board of Directors of
\nthe Company is pleased to announce the audited consolidated annual\u00a0results of the Group for the year ended December 31, 2020, together with
\nthe comparative figures\u00a0for year ended December 31, 2019 as follows. These consolidated
\nfinancial statements of the\u00a0Group for the Reporting Period have been reviewed by the Audit Committee
\nand audited by the\u00a0Company’s auditors, Deloitte Touche Tohmatsu.<\/p>\n![](\"https:\/\/release.media-outreach.com\/release.php\/Images\/Thumb\/500x0\/134316\/Company-Photo.jpg#image-134316\")
<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
In this announcement, “we”, “us” and “our” refer to the Company and
\nwhere the context otherwise\u00a0requires, the Group. Certain amounts and percentage figures included in
\nthis announcement have\u00a0been subject to rounding adjustments, or have been rounded to one or two
\ndecimal places. Any\u00a0discrepancies in any table, chart or elsewhere between totals and sums of
\namounts listed therein\u00a0are due to rounding.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
BUSINESS HIGHLIGHTS<\/b><\/p>\n
\n
<\/p>\n
During the Reporting Period, we have increased our drug assets to 17 in
\nour product portfolio\u00a0with full coverage of front-of-the-eye and back-of-the-eye diseases. Comparing to having only\u00a0one phase III clinical trial at the time of our Listing, to date, we
\nhave further initiated five\u00a0phase III clinical trails for our relevant drug candidates, and have six
\nongoing phase III clinical\u00a0trials in aggregate. Our drug candidates target various ophthalmology
\nfields which require\u00a0urgent medical treatment, including uveitis, myopia in children,
\nconjunctivitis, glaucoma and\u00a0wet age-related macular degeneration. Our significant progress in phase
\nIII clinical trials also\u00a0make us a leading company in terms of ophthalmic innovative drugs in
\nChina in terms of the\u00a0number of innovative opthalmic drugs currently in phase III clinical
\ntrials registered with CDE.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
During the Reporting Period, Hainan Provincial Drug Administration
\nlisted OT-401 (fluocinolone\u00a0intravitreal implant), our Core Product and one of our key drug
\ncandidates, in the list of drug\u00a0real-world study pilot programs (\u85e5\u54c1\u771f\u5be6\u4e16\u754c\u7814\u7a76\u8a66\u9ede\u540d\u55ae). It is one of the first batch\u00a0of pharmaceuticals that have been included drugs in RWS pilot programs. As a result, the\u00a0commercialization progress of OT-401 is expected to be
\naccelerated.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
As of the date of this announcement, we have commenced a phase III
\nclinical trial for OT-101,\u00a0our self-developed low-concentration atropine, in the United States. We
\nare planning to apply\u00a0for a multi-regional phase III clinical trial in China and Europe for
\nOT-101, which is expected\u00a0to be the first international multi-regional phase III clinical trial
\nfor low-concentration atropine\u00a0or its similar pharmaceuticals that includes Chinese population.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
During the Reporting Period, we actively promoted OT-401, brimonidine
\ntartrate eye drop, Ou\u00a0Qin and Kangshu (\u5eb7\u59dd) and achieved a total sales revenue amounted to RMB13.1 million,\u00a0representing a year-on-year growth of 6,792.6%, while our gross profit
\nmargin was 86.8%\u00a0for the same year. In January 2021, the amount of monthly sales have
\nreached approximately\u00a0RMB5.0 million (unaudited). Our quarter-on-quarter compound growth rate
\nis approximately\u00a0215.5% since the commercialization of our first drug.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
As of December 31, 2020, we had 69 employees in our sales and marketing
\nteam with\u00a0coverage of 267 hospitals nationwide, among which, 53 are Grade III
\nhospitals. Our Company\u00a0has primarily established a professional promotion team with extensive experience covering\u00a0nationwide ophthalmology market, which further assists our Company’s
\ncommercialized\u00a0products to penetrate into the hospital market in a swift manner.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
As of the date of this announcement, the construction of our Suzhou
\nmanufacture site is close\u00a0to completion. With a designed annual production capacity of 455 million
\ndoses, our Suzhou\u00a0manufacture site is expected to commence pilot production in September
\n2021 with an aim to\u00a0further lower product cost and increase sales profit
\nmargin.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
FINANCIAL HIGHLIGHTS<\/b><\/p>\n
\n
<\/p>\n
We recorded adjusted loss and total comprehensive expenses of RMB276.7
\nmillion for the\u00a0year ended December 31, 2020, representing an increase of RMB194.3
\nmillion from RMB82.4\u00a0million for the year ended December 31, 2019, primarily attributable to
\nthe listing expenses\u00a0of RMB41.1 million as well as an increase in selling and marketing
\nexpenses establishing our\u00a0commercialization infrastructure.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
This adjusted loss is arrived at by deducting the IFRS loss and total
\ncomprehensive expenses\u00a0of RMB2,264.9 million (2019: RMB1,325.5 million) from (i) an one-time,
\nnon-cash, IFRS fair\u00a0value adjustments loss of RMB1,694.5 million for our pre-IPO preferred
\nshares, which was\u00a0subsequently converted to Shares upon Listing, and (ii) the share-based
\npayment expenses of\u00a0RMB293.6 million.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
Our total revenue was RMB13.1 million for the year ended December 31,
\n2020, representing\u00a0a significant increase from RMB0.2 million for year ended December 31,
\n2019, primarily\u00a0attributable to the revenue generated from the commercialization and
\nmarketing of Ou Qin\u00a0and brimonidine tartrate eye drop in addition to the revenue generated
\nfrom the sales of OT-401 under the Boao Pilot Program. For the year ended December 31, 2020,
\nour total revenue\u00a0average quarterly growth rate was 215.5%, despite the
\nimpact of COVID-19.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
Our gross profit margin, which was 86.8% for the year ended December 31,
\n2020, slightly\u00a0decreased as compared with 94.7% for the year ended December 31, 2019.
\nThis was primarily\u00a0due to the diversification of our product mix and was partly offset by
\nlowered cost of existing\u00a0product.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
Our research and development expenses and capitalized development cost
\namount to RMB355.4\u00a0million for the year ended December 31, 2020 representing an increase of
\n257% from RMB99.5\u00a0million for the year ended December 31, 2019. The spending was mainly
\nincurred from the\u00a0real world study for OT 401 and multiple pivotal phase III clinical
\ntrial of our drug candidates,\u00a0including OT-401, OT-101, OT-702, OT-1001, and OT-301, as well as the increased
\nresearch\u00a0needs of our other drug candidates.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
As of December 31, 2020, we had approximately RMB2,051.8 million in bank
\nbalances\u00a0and cash, which does not include the gross proceeds of HK$793.8 million
\nfrom the top-up\u00a0subscription of new Shares conducted by our Company in
\nJanuary 2021.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n
\n
<\/p>\n
CORPORATE PROFILE<\/b><\/p>\n
\n
<\/p>\n
Overview<\/b><\/p>\n
\n
<\/p>\n
We are a China-based ophthalmic pharmaceutical platform company
\ndedicated to identifying,\u00a0developing and commercializing first- or best-in-class ophthalmic therapies. Our vision is to\u00a0provide a world-class pharmaceutical total solution to address
\nsignificant unmet ophthalmic\u00a0medical needs in China. We believe our platform positions us well to
\nachieve leadership in China\u00a0ophthalmology, with a first-mover advantage over future competitors.\u00a0Leveraging our platforms, we have built a strategically designed
\nophthalmic drug portfolio that is\u00a0comprehensive, innovative and validated. To date, we had 17 drug assets
\nin our portfolio, covering\u00a0all major front- and back-of-the-eye diseases. We have five key drug
\ncandidates in phase III\u00a0clinical development stage, which we believe will potentially be first-
\nor best-in-class if approved\u00a0and have significant near-term revenue potential from as early as 2022.
\nOur product portfolio\u00a0includes three of the ten ophthalmic drugs approved by the FDA since
\n2015 that are not yet\u00a0available in China in any formulation. Additionally, our product
\nportfolio includes three drugs that\u00a0are in or near the commercial stage.<\/p>\n
\n
<\/p>\n
\u00a0<\/p>\n<\/p><\/div>\n\n
Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"HONG
KONG SAR –\u00a0Media
OutReach\u00a0– 22 March 2021 – The Board of Directors of
the Company is pleased to announce the audited consolidated annual\u00a0results of the Group for the year ended December 31, 2020, together with
the comparative figures\u00a0for year ended December 31, 2019 as follows. These consolidated
financial statements of the\u00a0Group for the Reporting …<\/p>\n","protected":false},"author":1,"featured_media":13382,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[60],"tags":[],"_links":{"self":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts\/13381"}],"collection":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/comments?post=13381"}],"version-history":[{"count":0,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts\/13381\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/media\/13382"}],"wp:attachment":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/media?parent=13381"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/categories?post=13381"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/tags?post=13381"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}