On November 26, 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 nine months ended September 30, 2021 (Press release, Anpac Bio, NOV 26, 2021, View Source [SID1234596104]). The Company’s financial statements and related financial information for the quarter ended September 30, 2021 are unaudited and 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:

Total revenue was approximately RMB13.7 million (US$2.1 million) for the nine months ended September 30, 2021, an increase of 55.3% from RMB8.8 million for the same period of 2020.
Gross profit margin was 59.3% for the nine months ended September 30, 2021, representing an increase of 8.8% from 50.5% for the same period of 2020, primarily due to higher selling prices charged for cancer differentiation analysis ("CDA")-based tests and improved operational efficiency during the nine months ended September 30, 2021.
The average selling price ("ASP") of CDA-based tests was RMB463(US$71.6) for the nine months ended September 30, 2021, an increase of RMB194, or 72.3% from RMB269 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 approximately RMB89.0 million (US$13.8 million) for the nine months ended September 30, 2021, representing an increase of approximately RMB19.5 million from RMB69.5 million for the same period of 2020, primarily due to the Company recognized an aggregated unrealized loss of approximately RMB9.3 million (US$1.4 million) in related to changes in fair value of convertible debt for the nine months ended September 30, 2021, while in the same period of 2020 it was an unrealized gain of approximately RMB7.3 million.
Non-GAAP net loss1 was approximately RMB55.0 million (US$8.5 million) for the nine months ended September 30, 2021, reduced from a non-GAAP net loss of approximately RMB59.1 million for the nine months ended September 30, 2020. Non-GAAP net loss was reduced by 6.8% compared with the nine months ended September 30, 2020.
Short-term debt was approximately RMB30.0 million (US$4.6 million) as of September 30, 2021, an increase of 264.5% 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.
As of September 30, 2021, the Company had cash and cash equivalents of approximately RMB5.5 million (US$0.8 million), compared to RMB3.0 million as of December 31, 2020.
(1) Non-GAAP net loss is defined as net loss excluding change in fair value of convertible debts and stock-based compensation. For more information, refer to "Use of Non-GAAP Financial Measures" and "Reconciliations of Non-GAAP Results" at the end of this press release.

Business Highlights for the Nine Months Ended September 30, 2021

On August 18, 2021, the Company completed an acquisition of 60% equity interest in Anpai (Shanghai) Health Management Consulting Co., Ltd ("Anpai Shanghai"), consisting of an acquisition of 40% equity interest of Anpai Shanghai from Dr. Chris Chang Yu for a consideration of RMB 8.5 million approved by the Board of Directors, and an investment of 20% equity interest in Anpai Shanghai which the Company has already held prior to August 18, 2021. Anpai Shanghai is engaged in providing medical screen and detection service in the PRC.
The Company continued to receive validation on the efficacy of CDA testing through clinical study follow-ups. As of September 30, 2021, AnPac Bio had contacted 24,823 individuals tested using CDA packages in China and received substantive feedback regarding health conditions and disease development from 14,806 individuals.
Completed development and evaluation of a second-generation cancer detection sensor with improvements in multiple areas including reduced device cost, improved signal stability, cancer detection sensitivity and specificity.
Launched a joint venture to focus on a novel cancer treatment technology and medical device development which leverages AnPac Bio’s deep and extensive knowledge and experience in biophysics and its correlations with cancer occurrence and cancer detection.
As of September 30, 2021, the Company filed 261 patent applications globally, among which 150 patents had been granted, including 20 patents granted in the United States, 66 in greater China (including eight in Taiwan), and 64 in other countries and regions.
The Company continued to build a cancer risk assessment database, which totaled approximately 244,310 samples as of September 30, 2021, including approximately 200,330 samples from commercial CDA-based tests and approximately 43,980 samples from research studies.
Dr. Chris Yu, AnPac Bio’s Chairman and CEO commented: "We are very pleased with our progress in research and development, commercialization, and operational performance for the first 9 months in 2021. We grew revenue by 55.3% and gross margin by 8.8 percentage points. At the same time, we reduced non-GAAP loss by 6.0%. Our number of issued patents, and clinical and commercial sample sizes all reached record high in Q3, 2021. We are making solid progress in obtaining regulatory approval for our class III medical device for lung cancer assisting in diagnosis and have also submitted application for registration testing of our multi-cancer detection medical device for 11 types of cancer. We are also working very hard to obtain Laboratory Developed Test (LDT) status for our CDA cancer test in the US. Based on our current status and progress, we now expect to obtain registration approval for our class III medical device (for lung cancer assisting in diagnosis) in late 2022."

Key Items of Financial Results for the Nine Months Ended September 30, 2021

Revenue

Total revenues increased by 55.3% to approximately RMB13.7 million (US$2.1million) for the nine months ended September 30, 2021 from approximately RMB8.8 million for the same period 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 27.8% to approximately RMB5.6 million (US$862,000) for the nine months ended September 30, 2021 from approximately RMB4.4 million for the same period of 2020, primarily due to the increased staff costs.

Gross Profit and Gross Margin

Gross margin was 59.3% for the nine months ended September 30, 2021, representing a significant increase from 50.5% for the same period of 2020, primarily due to higher selling prices we charged for CDA-based tests.

Selling and Marketing Expenses

Selling and marketing expenses increased by 66.4% to approximately RMB17.3 million (US$2.7 million) for the nine months ended September 30, 2021 from approximately RMB10.4 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 5.7% to approximately RMB11.9 million (US$1.8 million) for the nine months ended September 30, 2021 from approximately RMB11.2 million for the same period of 2020, primarily due to the increased share-based compensation for our research and development personnel.

General and Administrative Expenses

General and administrative expenses decreased by 3.1% to approximately RMB58.9 million (US$9.1 million) for the nine months ended September 30, 2021 from approximately RMB60.8 million for the same period of 2020, primarily due to the decreased listing-related professional fees.

Change in fair value of convertible debt

The Company recognized the convertible debt at fair value. For the nine months ended September 30, 2021 and 2020, the Company recognized an aggregated unrealized loss of approximately RMB9.3 million (US$1.4 million) and unrealized gain of approximately RMB7.3 million, respectively, due to changes in fair value of convertible debt.

Gain from fair value change in equity investment

For the nine months ended September 30, 2020, the Company recorded a gain from fair value change in equity investment of approximately RMB3.2 million (US$489,000) due to the acquisition of Anpai Shanghai.

Net Loss

Net loss increased to approximately RMB89.0 million (US$13.8 million) for the nine months ended September 30, 2021, compared to approximately RMB69.5 million for the same period of 2020. Basic and diluted loss per share was RMB6.52 (US$1.01) for the nine months ended September 30, 2021, compared to that of RMB6.22 for the same period of 2020.

Balance Sheet

As of September 30, 2021, the Company had cash and cash equivalents of approximately RMB5.5 million (US$0.8 million), compared to approximately RMB3.0 million as of December 31, 2020.