Ocumension Therapeutics: Annual Results Announcement For The Year Ended December 31, 2020

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.

 

BUSINESS HIGHLIGHTS

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.

 

FINANCIAL HIGHLIGHTS

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.

 

CORPORATE PROFILE

Overview

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.