This story has been updated with information from Genetron's call with investors.
NEW YORK – Genetron Health said on Tuesday that its fourth quarter revenues were up nearly 10 percent year over year.
For the three months ended Dec. 31, 2020, the Chinese precision oncology platform company reported RMB 146.9 million (US$23.0 million) for the quarter, up from RMB 133.9 million in the same period of 2020.
Diagnosis and monitoring revenue increased by about 5 percent to RMB 130.0 million in Q4 2021 from RMB 123.5 million in the same period in 2020. The increase was primarily driven by the sale of IVD products, partially offset by a decrease in revenue from the provision of LDT services.
Genetron's Q4 IVD revenue meanwhile, rose 66 percent to RMB 44.1 million from RMB 26.5 million, driven by sales of the firm's S5 instrument and eight-gene Lung Cancer Assay. Revenue from in-house LDT assays was RMB 85.9 million, down about 11 percent from the same period in 2020.
"In China as the current regulations stand, the IVD in-hospital market is a segment where there is a clear pathway for potential government reimbursement. Moving forward, we intend to invest resources to further penetrate the hospital market with our solutions," Genetron Chairman and CEO Sizhen Wang said during a call with investors.
The company said grew its in-hospital IVD partners to 30 as of the end of Q4 2021 from 22 at the end of the prior year. It sold approximately 5,880 LDT assays in the fourth quarter, up 10 percent from the same period of 2020. These included sales of its liquid biopsy early screening product HCCscreen.
Revenue generated from development services was RMB 16.9 million in Q4 2021 up about 61 percent from RMB 10.5 million in the same period of 2020.
During the call, Wang highlighted the firm's recent progress in establishing partnerships with pharma, including deals with AstraZeneca, Fosun Pharma and recently with Hutchmed to develop new tests and expand the commercialization of its existing assays.
The Hutchmed partnership involves the joint development of a companion diagnostic test in China for the pharma firm's Orpathys (savolitinib), a lung cancer tyrosine kinase inhibitor, using Genetrong's existing eight-gene lung cancer IVD.
"We're excited about this partnership as it is our second major CDx after [our] deal with CStone for avapritinib, which has already entered the NMPA priority review and approval process," Wang said.
"In China, the trend of CDx demand is growing stronger… This, together with our CLIA lab in Maryland, provides us with lots of opportunity to work on cross-border trials and CDx developments [and] we anticipate continued strong growth in this exciting business segment," he added.
The firm's Q4 R&D expenses for Q4 2021were RMB 85.5 million, up 61 percent from RMB 53 million in the same period of 2020. Its SG&A expenses rose about 42 percent to RMB 165.1 million in Q4 2021 from RMB 116.3 million in the same period of 2020 as the company increased its headcount.
Genetron's net loss for the quarter was RMB 165.3 million, or RMB 0.35 per share, compared to RMB 73.2 million, or RMB 0.16 per share, in Q4 2020.
For full-year 2020, the company reported RMB 532.0 million million in total revenues, up about 25 percent over RMB 424.5 million in 2020.
Genetron's 2021 diagnosis and monitoring revenue increased by 28 percent to RMB 492.4 million from RMB 385.7 million, with both LDT services and the sale of IVD products increasing over the prior year.
Revenue generated from the provision of LDT services was up 16 percent at RMB 337.8 million compared to RMB 291.7 million in 2020. The firm said it sold approximately 24,360 LDT diagnostic tests over the course of 2021.
"This was the first full year that we introduced our early screening test as an LDT. And we are happy with the performance and believe that early screening will be a growth driver continuously for 2022 as we continue to roll out our commercialization strategy," Wang said during the call.
Revenue generated from sale of IVD products was RMB 154.5 million in 2021, up 64 percent from RMB 94 million in 2020.
Genetron's full-year development services revenue increased by 2 percent to RMB 39.6 million RMB 38.8 million in 2020, driven by the growth in revenue generated from biopharmaceutical services and partially offset by a decrease in revenue generated from sequencing services.
The company's 2021 R&D expenses increased 70 percent to RMB 254.0 million from RMB 149.0 million in 2020, while its SG&A spending was up about 53 percent at RMB 570.2 million compared to RMB 373.3 million.
Genetron's net loss for the year was RMB 502.6 million, or RMB 1.08 per share, compared to RMB 3.1 billion, or RMB 10.18 per share, in 2020.
The firm ended the year with RMB 639 million in cash and cash equivalents.
Genetron said it expects its full year 2022 revenue to be between RMB 585 and 638 million, which would represent up to 20 percent growth over its revenue in 2021.
"As we have communicated, the continued enforcement of the 'zero COVID' strategy in China has created a challenging operating environment that we will continue to navigate. We plan to execute across the business in a catalyst rich 2022 by introducing new products to the market, advancing our innovative pipeline and providing key data and trial updates that will further differentiate our portfolio of diagnostics," Wang added in a statement.