NEW YORK – Invitae reported after the close of the market Wednesday that its fourth quarter 2020 revenues increased 51 percent from the prior year.
For the three months ended Dec. 31, 2020, Invitae reported $100.4 million in revenues compared to $66.3 million in Q4 2019, exceeding the consensus Wall Street estimate of $98.4 million. Invitae reported testing revenue of $96.8 million for the quarter, as well as $3.6 million in other revenue.
Invitae billed for 238,000 tests in Q4 2020, but it has stopped reporting accessioned samples.
"Even amid the challenges of the pandemic, the durability of our relationships and the value of the information we provide to clinicians and patients was clear," Invitae Co-founder and CEO Sean George said in a statement.
Its R&D spending in Q4 was $72.2 million, up 41 percent from $51.3 million in the year-ago period. Meanwhile, its SG&A costs increased fourfold year over year to $291.4 million from $57.3 million.
Invitae's net loss for the quarter was $241.0 million, or $1.34 per share, compared to a net loss of $76.9 million, or $.79 per share, in Q4 2019. On an adjusted basis, its net loss for Q4 2020 was $113.1 million, or $.63 per share, higher than analysts' average estimate for a loss per share of $.55.
For full-year 2020, Invitae's revenues increased 29 percent to $279.6 million compared to $216.8 million in 2019, and above analysts' consensus estimate of $276.7 million. During the year, its testing revenue was $272.3 million and other revenues amounted to $7.3 million.
The firm billed for 659,000 tests in 2020, marking a 41 percent increase year over year. International billable test volume comprised 13 percent of the total in 2020, driven by the strength of recently acquired ArcherDX's presence outside the US and growth in Invitae's base business in Q4. (Billable test volume includes individual test reports and units, or reactions, which is defined by ArcherDX has set of reagents customized to perform an NGS test.)
Following the ArcherDX acquisition, Invitae announced in November that it has submitted a premarket approval application to the US Food and Drug Administration for the Stratified next-generation sequencing test for personalizing cancer treatments. The tissue- and blood-based test will be marketed as a distributed kit with companion diagnostic claims.
On a call with investors and analysts, George said that by being able to offer a distributed test kit that cancer centers and healthcare systems can set up in their own labs, Invitae will be able to meet the needs of cancer patients regardless of where they receive care. However, several analysts wondered whether hospitals are likely to adopt a test kit, instead of setting up their own in-house lab-developed tests.
"It's pretty clear there are going to be places that want to run it locally regardless of any other factors that might push that decision-making one way or another," George acknowledged, but he suggested others will be attracted to the kit based on pricing, easier set up and validation, and FDA-approved status.
Invitae’s net loss for FY 2020 was $608.9 million, or $4.52 per share, compared to a net loss of $242.0 million, or $2.66 per share, in 2019. Its non-GAAP net loss for FY 2020 was $373.9 million, or $2.78 per share, lower than analysts' average estimate for a loss of $2.88 per share.
The firm reported R&D costs of $240.6 million in 2020, a 70 percent increase from $141.5 million in 2019. SG&A spending rose more than doubled to $492.9 million in 2020 from $201.3 million in 2019.
Invitae ended the year with $354.0 million in cash, cash equivalents, and marketable securities.
In 2021, one of the first announcements from the company was that it would collaborate with PacBio to develop a production-scale, high-throughput whole-genome sequencing platform for clinical use that would eventually cost less than $1,000. During the call, George expressed optimism that such testing would be reimbursed by payors, since some are already paying $3,000 to $5,000 for exome testing for babies in neonatal intensive care units. But, he said that the company would also have a patient-pay price for families without coverage who are on a diagnostic odyssey.
For 2021, the company projects annual revenues of greater than $450 million, after factoring in the impact from the COVID-19 pandemic. The firm has said it is expecting to grow revenues by 50 percent to 60 percent over the next few years.