On May 27, 2021 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, reported its unaudited financial results for the first quarter ended March 31, 2021 (Press release, Anpac Bio, MAY 27, 2021, View Source [SID1234580678]). 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.

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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."