AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or
“we”) (NASDAQ: ANPC), a biotechnology company with operations in
China and the United States, announced today its annual financial
results for the year ended December 31, 2020.
Financial Highlights for Fiscal Year
2020
- Total revenues were RMB20.5 million
(US$3.1 million) in fiscal year 2020, an increase of 89.1% from
RMB10.8 million (US$1.6 million) in fiscal year 2019.
- Gross margin was 62.8% in fiscal
year 2020, an increase of 18.6% from 44.2% in fiscal year
2019.
- The average selling price (“ASP”)
of CDA-based tests was RMB446 (US$68.4) in fiscal year 2020,
increased by RMB248, or 125.3% from RMB198 in fiscal year 2019,
primarily due to a broader product offering of more comprehensive
multi-cancer detection tests at higher price points.
- Net loss decreased to RMB80.6
million (US$12.3 million) in fiscal year 2020 from RMB101.6 million
in fiscal year 2019. The net loss in fiscal year 2020 was mainly
attributable to RMB 19.7 million (US$ 3.0 million) selling and
marketing expenses and RMB 74.8 million (US$ 11.5 million) general
and administrative expenses.
- Short-term debt decreased
significantly (a decrease of approximately 78.7%) compared to the
end of last fiscal year (December 31, 2019).
Business Highlights for Fiscal Year
2020
- The Company successfully listed on
the NASDAQ stock exchange on January 30, 2020.
- Two new products were launched,
including a proprietary immunology test named AnPac Defense Medical
Examination (“ADME”) and a new cancer test package named AnPac Pan
Cancer Screening (“APCS”) combining CDA technology with ct-DNA
methods.
- The Company continued to receive
validation on the efficacy of CDA testing through clinical study
follow-ups. As of December 31, 2020, AnPac Bio had contacted
22,979 individuals tested using CDA packages in China and received
substantive feedback regarding health conditions and disease
development from 13,859 individuals.
- As of December 31, 2020, the
Company filed 237 patent applications globally; among these, 141
patents have been granted.
- The Company continued to build a
cancer risk assessment database, which totaled approximately
216,560 samples as of December 31, 2020, including approximately
172,860 samples from commercial CDA-based tests and approximately
43,700 samples from research studies.
- The San Jose, California US lab
received the College of American Pathologists (“CAP”)
certification. The lab also has completed the validation of a
COVID-19 antibody test using a major supplier’s FDA emergency use
authorized equipment, and is capable of commercializing the
test.
- The Philadelphia, Pennsylvania US
lab completed renovations and in August 2020, the lab received CLIA
certification.
Dr. Chris Yu, CEO and Chairman of AnPac Bio
commented: “We are very pleased with our excellent financial
performance in 2020. Although the COVID-19 pandemic adversely
impacted businesses around the world over the last year, AnPac Bio
still achieved significant growth in its revenues and gross margin
while reducing its net loss by approximately 20.7%. This
illustrated the capabilities of Anpac Bio’s management team and
also demonstrated that our technology and products are getting
increased acceptance in the marketplace.
AnPac Bio developed two new products in 2020
which continue to gain traction with our customers. Our issued
patents reached 141 at the end of 2020. We are proud of what AnPac
Bio has achieved in 2020. We will continue to focus on research and
development, obtaining the Class III medical device registration
certificate in China, marketing our test as a laboratory developed
test, or LDT, in the U.S., launching new products, and controlling
costs and expenses.
As we enter 2021, we are capitalizing on an
expanding market and customer acceptance of AnPac’s products and
services and are driven by our vision to be a market leader around
the globe in early-stage cancer screening and detection. As we
announced recently, we have achieved a record Q1 for paid CDA-based
cancer test volume in 2021.”
Financial Results for Fiscal Year
2020
Revenue
Total revenues increased by 89.1% to RMB20.5
million (US$3.1 million) in fiscal year 2020 from RMB10.8 million
(US$1.6 million) in fiscal year 2019, primarily due to a
significant increase in our revenue from cancer screening and
detection tests.
Cost of Revenues
Cost of revenues increased by 26.1% to RMB7.6
million (US$1.2 million) in fiscal year 2020 from RMB6.0 million in
fiscal year 2019. The increase was primarily attributable to an
increase in depreciation expense, as we put more CDA devices into
use to carry out our CDA-based tests.
Gross Profit and Gross Margin
Gross profit increased by 168.5% to RMB12.9
million (US$2.0 million) in fiscal year 2020 from RMB4.8 million in
fiscal year 2019. Gross margin was 62.8% in fiscal year 2020, an
increase of 18.6 percentage points from 44.2% in fiscal year
2019.
Selling and Marketing Expenses
Selling and marketing expenses increased by
44.3% to RMB19.7 million (US$3.0 million) in fiscal year 2020 from
RMB13.6 million in fiscal year 2019, primarily due to higher
marketing expenses as a result of our enhanced marketing
efforts.
Research and Development Expenses
Research and development expenses increased by
17.7% to RMB11.6 million (US$1.8 million) in fiscal year 2020 from
RMB9.8 million in fiscal year 2019, primarily due to the increased
research and development activities we conducted in 2020.
General and Administrative Expenses
General and administrative expenses increased by
8.2% to RMB74.8 million (US$11.5 million) in fiscal year 2020 from
RMB69.1 million in fiscal year 2019, primarily due to increased
listing-related professional fees as well as increased staff
compensation incurred in 2020.
Net Loss
Net loss was decreased to RMB80.6 million
(US$12.3 million) in fiscal year 2020, compared to RMB101.6 million
in fiscal year 2019. Basic and diluted loss per share was RMB7.19
(US$1.10) in fiscal year 2020, compared to that of RMB11.31 in
fiscal year 2019.
Balance Sheet
As of December 31, 2020, the Company had cash
and cash equivalents of RMB3.0 million (US$462,000), compared to
RMB6.1 million as of December 31, 2019.
Cash Flow
Net cash used in operating activities was
RMB59.0 million (US$9.0 million) in fiscal year 2020, compared to
RMB48.6 million in fiscal year 2019.
Net cash used in investing activities was RMB2.5
million (US$380,000) in fiscal year 2020, compared to RMB3.5
million in fiscal year 2019.
Net cash provided by financing activities was
RMB60.9 million (US$9.3 million) in fiscal year 2020, compared to
RMB46.1 million in fiscal year 2019.
Conference Call
The Company’s management will host an earnings
conference call at 8:30 am US Eastern Time on April 30, 2021 (5:30
am US Pacific Time/8:30 pm Beijing Time) to discuss the financial
results for the year ended December 31, 2020. To attend this
earnings conference call, please use the information below for
either dial-in access or webcast access. When prompted, please
reference “AnPac Bio/ANPC”.
Conference Call |
Date: |
April 30, 2021 |
Time: |
8:30 am ET, U.S. |
International Toll Free: |
United States: +1 888-346-8982Mainland China: +86 400-120-1203Hong
Kong: +852 800-905-945 |
International: |
International: +1 412-902-4272 |
Conference ID: |
AnPac Bio-Medical Science Co., Ltd. |
Please dial in at least 15 minutes before the
commencement of the call to ensure timely participation. For those
unable to participate, an audio replay of the conference call will
be available from approximately one hour after the end of the live
call until May 7, 2021. The dial-in for the replay is +1
877-344-7529 within the United States or +1 412-317-0088
internationally. The replay access code is 10153699.
A live webcast of the call will also be available at
https://services.choruscall.com/links/anpc210329.html.
About AnPac Bio
AnPac Bio is a biotechnology company focused on
early cancer screening and detection, with 142 issued patents as of
March 31, 2021. With two certified clinical laboratories in China
and one CLIA and CAP accredited clinical laboratory and one CLIA
registered clinical laboratory in the United States, AnPac Bio
performs a suite of cancer screening and detection tests, including
CDA (Cancer Differentiation Analysis), bio-chemical, immunological,
and genomics tests. According to Frost & Sullivan, AnPac Bio
ranked third worldwide among companies offering next-generation
early cancer screening and detection technologies in terms of the
number of clinical samples for cancer screening and detection,
based on approximately 41,700 clinical samples as of December 31,
2019. AnPac Bio’s CDA technology platform has been shown in
retrospective validation studies to be able to detect the risk of
over 20 different cancer types with high sensitivity and
specificity.
For more information, please visit:
https://www.Anpacbio.com.
For investor and media inquiries, please
contact:
Company:Phil Case, Marketing and Investor RelationsPhone:
+1-267-810-6776 (US)Email: phil_case@AnPacbio.com
Investor Relations:Ascent Investor Relations LLCTina Xiao,
PresidentPhone: +1-917-609-0333
(US)Email: tina.xiao@ascent-ir.com
Safe Harbor Statement
This announcement contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934.
These forward-looking statements are made under the “safe harbor”
provisions of the Private Securities Litigation Reform Act of 1995
and are relating to the Company's future financial and operating
performance. The Company has attempted to identify forward-looking
statements by terminologies including "believes," "estimates,"
"anticipates," "expects," "plans," "projects," "intends,"
"potential," “target,” “aim,” “predict,” “outlook,” “seek,” “goal”
“objective,” “assume,” “contemplate,” “continue,” “positioned,”
“forecast,” “likely,” "may," "could," "might," "will," "should,"
"approximately" or other words that convey uncertainty of future
events or outcomes to identify these forward-looking statements.
These statements are based on current expectations, assumptions and
uncertainties involving judgments about, among other things, future
economic, competitive and market conditions and future business
decisions, all of which are difficult or impossible to predict
accurately and many of which are beyond the Company's control.
These statements also involve known and unknown risks,
uncertainties and other factors that may cause the Company's actual
results to be materially different from those expressed or implied
by any forward-looking statement. Known and unknown risks,
uncertainties and other factors include, but are not limited to,
the implementation of our business model and growth strategies;
trends and competition in the cancer screening and detection
market; our expectations regarding demand for and market acceptance
of our cancer screening and detection tests and our ability to
expand our customer base; our ability to obtain and maintain
intellectual property protections for our CDA technology and our
continued research and development to keep pace with technology
developments; our ability to obtain and maintain regulatory
approvals from the NMPA, the FDA and the relevant U.S. states and
have our laboratories certified or accredited by authorities
including the CLIA; our future business development, financial
condition and results of operations and our ability to obtain
financing cost-effectively; potential changes of government
regulations; general economic and business conditions in China and
elsewhere; our ability to hire and maintain key personnel; our
relationship with our major business partners and customers; and
the duration of the coronavirus outbreaks and their potential
adverse impact on the economic conditions and financial markets and
our business and financial performance, such as resulting from
reduced commercial activities due to quarantines and travel
restrictions instituted by China, the U.S. and many other countries
around the world to contain the spread of the virus. Additionally,
all forward-looking statements are subject to the “Risk Factors”
detailed from time to time in the Company's most recent Annual
Report on Form 20-F and other filings with the U.S. Securities and
Exchange Commission. Because of these and other risks,
uncertainties and assumptions, undue reliance should not be placed
on these forward-looking statements. In addition, these statements
speak only as of the date of this press release and, except as may
be required by law, the Company undertakes no obligation to revise
or update publicly any forward-looking statements for any
reason.
ANPAC BIO-MEDICAL SCIENCE
CO., LTD.CONSOLIDATED BALANCE
SHEETS(Amounts in thousands of Renminbi (“RMB”)
and U.S. dollars (“US$”), except for number of shares and per share
data)
|
|
As of December 31, |
|
|
|
2019 |
|
2020 |
|
2020 |
|
|
|
RMB |
|
RMB |
|
US$ |
|
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
6,125 |
|
3,016 |
|
462 |
|
Advances to suppliers |
|
1,093 |
|
5,588 |
|
856 |
|
Accounts receivable, net |
|
1,295 |
|
7,792 |
|
1,194 |
|
Amounts due from related parties |
|
555 |
|
1,277 |
|
196 |
|
Inventories, net |
|
313 |
|
312 |
|
48 |
|
Other current assets, net |
|
12,790 |
|
3,303 |
|
506 |
|
Total current assets |
|
22,171 |
|
21,288 |
|
3,262 |
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
18,868 |
|
19,267 |
|
2,953 |
|
Land use rights, net |
|
1,194 |
|
1,166 |
|
179 |
|
Intangible assets, net |
|
5,200 |
|
4,596 |
|
704 |
|
Goodwill |
|
2,223 |
|
2,223 |
|
341 |
|
Long-term investments, net |
|
2,326 |
|
883 |
|
135 |
|
Other assets |
|
1,000 |
|
464 |
|
71 |
|
TOTAL ASSETS. |
|
52,982 |
|
49,887 |
|
7,645 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ DEFICIT |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Short-term debts |
|
38,568 |
|
8,232 |
|
1,262 |
|
Accounts payable |
|
1,800 |
|
2,127 |
|
325 |
|
Advance from customers |
|
2,450 |
|
3,682 |
|
564 |
|
Amounts due to related parties |
|
4,597 |
|
4,130 |
|
633 |
|
Accrued expenses and other current liabilities |
|
18,782 |
|
25,353 |
|
3,886 |
|
Total current liabilities |
|
66,197 |
|
43,524 |
|
6,670 |
|
|
|
|
|
|
|
|
|
Deferred tax liabilities |
|
1,134 |
|
1,045 |
|
160 |
|
Other long-term liabilities |
|
1,575 |
|
2,041 |
|
313 |
|
TOTAL LIABILITIES. |
|
68,906 |
|
46,610 |
|
7,143 |
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders’ (deficit) equity: |
|
|
|
|
|
|
|
Class A Ordinary shares ((US$0.01 par value per share;
70,000,000 shares authorized, 7,004,900 and 9,192,660 shares issued
and outstanding as of December 31, 2019 and 2020,
respectively) |
|
466 |
|
618 |
|
95 |
|
Class B Ordinary shares ((US$0.01 par value per share;
30,000,000 authorized, 2,863,100 shares issued and outstanding as
of December 31, 2019 and 2020) |
|
191 |
|
191 |
|
29 |
|
Additional paid-in capital |
|
257,736 |
|
354,295 |
|
54,298 |
|
Accumulated deficit |
|
(276,476 |
) |
(356,951 |
) |
(54,705 |
) |
Accumulated other comprehensive income |
|
2,110 |
|
4,795 |
|
735 |
|
Total AnPac Bio-Medical Science Co., Ltd. shareholders’
(deficit) equity |
|
(15,973 |
) |
2,948 |
|
452 |
|
Non-controlling interests |
|
49 |
|
329 |
|
50 |
|
Total shareholders’ (deficit) equity |
|
(15,924 |
) |
3,277 |
|
502 |
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND EQUITY |
|
52,982 |
|
49,887 |
|
7,645 |
|
ANPAC BIO-MEDICAL SCIENCE
CO., LTD.CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS(Amounts in
thousands of RMB and US$, except for number of shares and per share
data)
|
|
Year Ended December 31 |
|
|
|
2019 |
|
2020 |
|
2020 |
|
|
|
RMB |
|
RMB |
|
US$ |
|
Revenues: |
|
|
|
|
|
|
|
Cancer screening and detection tests |
|
10,381 |
|
18,445 |
|
2,827 |
|
Physical checkup packages, net |
|
464 |
|
2,064 |
|
316 |
|
Total revenues |
|
10,845 |
|
20,509 |
|
3,143 |
|
|
|
|
|
|
|
|
|
Cost of revenues, cancer screening |
|
(6,047 |
) |
(7,628 |
) |
(1,169 |
) |
|
|
|
|
|
|
|
|
Gross Profit |
|
4,798 |
|
12,881 |
|
1,974 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Selling and marketing |
|
(13,633 |
) |
(19,674 |
) |
(3,015 |
) |
Research and development |
|
(9,839 |
) |
(11,576 |
) |
(1,774 |
) |
General and administrative |
|
(69,088 |
) |
(74,757 |
) |
(11,457 |
) |
Impairment of long-term investments |
|
(1,320 |
) |
(1,430 |
) |
(219 |
) |
Loss from operations |
|
(89,082 |
) |
(94,556 |
) |
(14,491 |
) |
|
|
|
|
|
|
|
|
Non-operating income and expenses: |
|
|
|
|
|
|
|
Interest expense, net |
|
(2,609 |
) |
(1,143 |
) |
(175 |
) |
Foreign exchange loss, net |
|
(3,219 |
) |
(667 |
) |
(102 |
) |
Share of net (loss) gain in equity method investments |
|
190 |
|
(13 |
) |
(2 |
) |
Other income (expense), net |
|
(1,823 |
) |
9,096 |
|
1,394 |
|
Change in fair value of convertible debt and settlement gain |
|
(5,296 |
) |
6,630 |
|
1,016 |
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
(101,839 |
) |
(80,653 |
) |
(12,360 |
) |
Income tax benefit |
|
218 |
|
88 |
|
13 |
|
Net loss |
|
(101,621 |
) |
(80,565 |
) |
(12,347 |
) |
Net loss attributable to non-controlling
interests |
|
(561 |
) |
(90 |
) |
(14 |
) |
Net loss attributable to ordinary
shareholders |
|
(101,060 |
) |
(80,475 |
) |
(12,333 |
) |
|
|
|
|
|
|
|
|
Loss per share |
|
|
|
|
|
|
|
Class A and B Ordinary shares - basic and diluted |
|
(11.31 |
) |
(7.19 |
) |
(1.10 |
) |
|
|
|
|
|
|
|
|
Weighted average shares outstanding used in calculating
basic and diluted loss per share |
|
|
|
|
|
|
|
Ordinary shares - basic and diluted |
|
8,937,600 |
|
11,190,079 |
|
11,190,079 |
|
|
|
|
|
|
|
|
|
Other comprehensive (loss) income, net of
tax: |
|
|
|
|
|
|
|
Fair value change relating to Company’s own credit risk on
convertible loan |
|
(955 |
) |
(108 |
) |
(17 |
) |
Foreign currency translation adjustment |
|
2,978 |
|
2,793 |
|
428 |
|
Total comprehensive loss |
|
(99,598 |
) |
(77,880 |
) |
(11,936 |
) |
Total comprehensive loss attributable to non-controlling
interests |
|
(561 |
) |
(90 |
) |
(14 |
) |
|
|
|
|
|
|
|
|
Total comprehensive loss attributable to ordinary
shareholders |
|
(99,037 |
) |
(77,790 |
) |
(11,922 |
) |
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