UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of May 2021

 

Commission File Number: 001-39137

 

AnPac Bio-Medical Science Co., Ltd.
(Registrant’s name)

 

801 Bixing Street, Bihu County

Lishui, Zhejiang Province 323006

The People’s Republic of China
(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F x Form 40-F ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b) (1): ¨

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b) (7): ¨

 

 

 

 

 

EXHIBIT INDEX

 

Exhibit Number   Description
Exhibit 99.1   Press Release
Exhibit 99.2   Key Items of Financial Results for First Quarter 2021

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

    AnPac Bio-Medical Science Co., Ltd.
    (Registrant)
     
Date: May 27, 2021 By:

/s/ Chris Chang Yu

  Name: Dr. Chris Chang Yu
  Title: Chairman of the Board of Directors and Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

PRESS RELEASE  

 

AnPac Bio Reports Strong First Quarter in 2021, with 137.2% Increase in
Revenue and Record Number of Commercial Tests Completed

 

May 27, 2021

 

PHILADELPHIA, May 27, 2021 (GLOBE NEWSWIRE) — 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 unaudited financial results for the first quarter ended March 31, 2021. The Company's financial statements and related financial information for the quarter ended March 31, 2021 are unaudited or have not been reviewed by the Company's independent registered accountant. These financial results could differ materially if they were reviewed by the Company’s independent registered accountant.

 

Financial highlights for the First Quarter 2021

 

Total revenue was RMB2.2 million (US$0.3 million) for the first quarter of 2021, an increase of 137.2% from RMB0.9 million for the first quarter of 2020.

 

Gross profit margin was 58.4% for the first quarter of 2021, representing an increase of 25.7 % from 32.7% for the first quarter of 2020, primarily due to higher selling prices charged for CDA-based tests and improved operational efficiency as well as higher volume of CDA-based tests performed during the first quarter of 2021.

 

The average selling price (“ASP”) of CDA-based tests was RMB401.0(US$61.2) for the first quarter of 2021, an increase of RMB20.0, or 5.0% from RMB381.0 in the same period of 2020, primarily due to a broader product offering of more comprehensive multi-cancer detection tests at higher price points.

 

Net loss was RMB29.3 million (US$4.5 million) for the first quarter of 2021, compared to a net loss of RMB21.2 million for the first quarter of 2020. The net loss for the first quarter of 2021 was mainly attributable to RMB3.2 million (US$0.5 million) changes in the fair value of the convertible debts, RMB3.9 million (US$0.6 million) of selling and marketing expenses, RMB3.4 million (US$0.5 million) of research and development expenses and RMB 19.2 million (US$2.9 million) of general and administrative expenses.

 

Short-term debt was RMB22.4 million (US$3.4 million) as of March 31, 2021, an increase of 171.9% from RMB8.2 million at the end of last fiscal year (December 31, 2020). The increase in short-term debt was mainly due to issuance of additional convertible debentures with a fair value of USD$2.5 million.

   
  ·    As of March 31, 2021, the Company had cash and cash equivalents of RMB9.0 million (US$1.4 million), compared to RMB3.0 million as of December 31, 2020.

 

 

 

 

Business Highlights for the First Quarter of 2021

 

The Company reached a record high number of commercial CDA tests for the 1st Quarter versus any previous Q1 in the Company’s history

 

The Company has developed and completed testing at the end of February 2021 of a new generation of multi-cancer detection sensor named CDA Pro Sensor (CDAPS) which is a technology breakthrough with improved performance over the previous generation cancer detection sensors in a number of areas, including detection signal stability, sensor device yield, and detection sensitivity and specificity. The Company expects that CDAPS will extend the competitiveness for AnPac in the space of cancer screening.

   
On January 25, 2021, the National Medical Products Administration (NMPA), the regulatory agent for medical products in China, approved the Company to start registration testing of AnPac Bio’s class III lung cancer auxiliary diagnosis medical device at its designated medical device testing laboratory, which is a major progress and step towards obtaining a Class III medical device registration certificate.
   
The Company continued to receive validation on the efficacy of CDA testing through follow-up studies. As of March 31, 2021, AnPac Bio had contacted 23,857 individuals tested using CDA packages in China and received substantive feedback regarding health conditions and disease development from 14,127 individuals.
   
As of March 31, 2021, the Company filed 237 patent applications globally, among which 142 patents had been granted, including 20 patents granted in the United States, 65 in greater China (including eight in Taiwan), and 57 in other countries and regions.
   
The Company continued to build a cancer risk assessment database, which totaled approximately 222,200 samples as of March 31, 2021, including approximately 178,300 samples from commercial CDA-based tests and approximately 43,900 samples from research studies.
   
Dr. Chris Yu, AnPac Bio’s Chairman and CEO commented: “We are very pleased with our strong Q1 performance results, including (1) a 137.2% in revenue increase over the same period last year, (2) development and final evaluations of our next generation of multi-cancer detection sensor technology which includes significant performance improvements, and (3) receiving approval from the National Medical Products Administration (NMPA) to start registration test of AnPac Bio’s class III lung cancer auxiliary diagnosis medical device.  We are going into Q2 with strong momentum.  Our continued focus in completing our Class III medical device registration and our new product development pipeline is showing great progress. We have also worked closely with our customers and commercial partners to achieve accelerated revenue growth.”

 

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 Relations
Phone: +1-267-810-6776 (US)
Email: phil_case@AnPacbio.com

 

Investor Relations:
Ascent Investor Relations LLC
Tina Xiao, President
Phone: +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.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(Amounts in thousands of Renminbi (“RMB”) and U.S. dollars (“US$”), except for number of shares and per share data)

   

    December 31, 2020     March 31, 2021     March 31, 2021  
    RMB     RMB     US$  
ASSETS             (Unaudited)       (Unaudited)  
Current assets:                        
Cash and cash equivalents     3,016       9,020       1,377  
Advances to suppliers     5,588       5,295       808  
Accounts receivable, net of allowance for doubtful accounts     7,792       4,443       678  
Amounts due from related parties     1,277       3,773       576  
Inventories     312       972       148  
Other current assets     3,303       9,792       1,495  
Total current assets     21,288       33,295       5,082  
                         
Property and equipment, net     19,267       19,183       2,928  
Land use rights, net     1,166       1,159       177  
Intangible assets, net     4,596       4,498       687  
Goodwill     2,223       2,223       339  
Long-term investments     883       805       123  
Other assets     464       466       71  
TOTAL ASSETS.     49,887       61,629       9,407  
                         
LIABILITIES AND SHAREHOLDERS’ DEFICIT                        
Current liabilities:                        
Short-term debt     8,232       22,380       3,416  
Accounts payable     2,127       687       105  
Advance from customers     3,682       4,040       617  
Amounts due to related parties     4,130       417       64  
Accrued expenses and other current liabilities     25,353       22,192       3,387  
Total current liabilities     43,524       49,716       7,589  
                         
Deferred tax liabilities     1,045       1,023       156  
Other long-term liabilities     2,041       2,038       311  
                         
TOTAL LIABILITIES.     46,610       52,777       8,056  
Commitments and contingencies                        
                         
Shareholders’ deficit:                        
Class A Ordinary shares ((US$0.01 par value per share; 70,000,000 shares authorized, 9,192,660 and 12,168,531 shares issued and outstanding as of December 31, 2020 and March 31, 2021, respectively)     618       811       124  
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, 2020 and March 31, 2021)     191       191       29  
Additional paid-in capital     354,295       390,527       59,606  
Accumulated deficit     (356,951 )     (385,980 )     (58,912 )
Accumulated other comprehensive income     4,795       3,191       487  
                         
Total AnPac Bio-Medical Science Co., Ltd. shareholders’ equity     2,948       8,740       1,334  
Non-controlling interests     329       112       17  
                         
Total shareholders’ equity     3,277       8,852       1,351  
                         
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY     49,887       61,629       9,407  

 

 

 

 

 ANPAC BIO-MEDICAL SCIENCE CO., LTD.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Amounts in thousands of Renminbi (“RMB”) and U.S. dollars (“US$”), except for number of shares and per share data)

 

    Three Months Ended March 31,  
    2020     2021     2021  
    RMB     RMB     US$  
Revenues:                  
Cancer screening and detection tests     884       2,182       333  
Physical checkup packages     37       3       0  
Total revenues     921       2,185       333  
                         
Cost of revenues     (620 )     (908 )     (139 )
                         
Gross Profit     301       1,277       194  
                         
Operating expenses:                        
Selling and marketing expenses     (3,596 )     (3,863 )     (590 )
Research and development expenses     (2,937 )     (3,356 )     (512 )
General and administrative expenses     (19,590 )     (19,226 )     (2,934 )
Impairment of long-term investments     (820 )     -       -  
                         
Loss from operations     (26,642 )     (25,168 )     (3,842 )
                         
Non-operating income and expenses:                        
Interest expense, net     (266 )     (624 )     (95 )
Foreign exchange gain (loss), net     118       (139 )     (21 )
Share of net loss in equity method investments     (21 )     (77 )     (12 )
Other income (expense), net     537       (45 )     (7 )
Change in fair value of convertible debt     5,041       (3,215 )     (491 )
                         
Loss before income taxes     (21,233 )     (29,268 )     (4,468 )
Income tax benefit     22       22       3  
                         
Net loss     (21,211 )     (29,246 )     (4,465 )
                         
Net loss attributable to non-controlling interests     (161 )     (217 )     (33 )
                         
Net loss attributable to ordinary shareholders     (21,050 )     (29,029 )     (4,432 )
                         
Loss per share:                        
Class A and B Ordinary shares - basic and diluted     (1.95 )     (2.43 )     (0.37 )
                         
Weighted average shares outstanding used in calculating basic and diluted loss per share                        
Ordinary shares - basic and diluted     10,771,722       11,958,033       11,958,033  
                         
Other comprehensive income, net of tax:                        
Fair value change relating to Company’s own credit risk on convertible loan     (108 )     -       -  
Foreign currency translation differences     2,717       (1,604 )     (245 )
                         
Total comprehensive loss     (18,602 )     (30,850 )     (4,710 )
Total comprehensive loss attributable to non-controlling interests     (161 )     (217 )     (33 )
                         
Total comprehensive loss attributable to ordinary shareholders     (18,441 )     (30,633 )     (4,677 )

 

 

 

 

Exhibit 99.2

 

Key Items of Financial Results for First Quarter 2021

 

Revenue

 

Total revenues increased by 137.2% to RMB2.2 million (US$0.3 million) for the first quarter of 2021 from RMB0.9 million for the first quarter of 2020, primarily due to a significant increase in our revenue from cancer screening and detection tests.

 

Cost of Revenues

 

Cost of revenues increased by 46.5% to RMB0.9 million (US$139,000) for the first quarter of 2021 from RMB0.6 million for the first quarter of 2020, primarily attributable to more CDA-based tests performed, which resulted in increased costs related to testing materials, blood sample taking and medical consumables.

 

Gross Profit and Gross Margin

 

Gross margin was 58.4% for the first quarter of 2021, representing a significant increase from 32.7% for the first quarter of 2020, primarily due to higher selling prices we charged for CDA-based tests and improved operational efficiency with higher volume of CDA-based tests performed during the first quarter of 2021 and less costs on outsourced biomarker-based tests.

 

Selling and Marketing Expenses

 

Selling and marketing expenses increased by 7.4% to RMB3.9 million (US$0.6 million) for the first quarter of 2021 from RMB3.6 million in the same period of 2020, primarily due to higher marketing expenses as a result of our enhanced marketing efforts.

 

Research and Development Expenses

 

Research and development expenses increased by 14.3% to RMB3.4 million (US$0.5 million) for the first quarter of 2021 from RMB2.9 million for the first quarter of 2020, primarily due to the increased staff costs and share-based compensation for our research and development personnel in the first quarter of 2021.

 

General and Administrative Expenses

 

General and administrative expenses decreased by 1.9% to RMB19.2 million (US$2.9 million) for the first quarter of 2021 from RMB19.6 million for the first quarter of 2020, primarily because we had listing-related professional fees for the first quarter of 2020 and did not have the same in the first quarter of 2021.

 

Change in fair value of convertible debts

 

The Company recognized the convertible debt at fair value. For the quarter ended March 31, 2021 and 2020, the Company recognized an aggregated unrealized loss of RMB3.2 million (US$0.5 million) and unrealized gain of RMB5.0 million, respectively, due to changes in fair value of the convertible debts.

 

 

 

 

Net Loss

 

Net loss increased to RMB29.2 million (US$4.5 million) for the first quarter of 2021, compared to RMB21.2 million for the first quarter of 2020. Basic and diluted loss per share was RMB2.43 (US$0.37) for the first quarter of 2021, compared to that of RMB1.95 for the first quarter of 2020.

 

Balance Sheet

 

As of March 31, 2021, the Company had cash and cash equivalents of RMB9.0 million (US$1.4 million), compared to RMB3.0 million as of December 31, 2020.

 

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