NEW YORK – Guardant Health said after the close of the market on Thursday that its fourth quarter 2024 revenues rose 30 percent year over year.
For the three months ended Dec. 31, 2024, the company recorded total revenues of $201.8 million compared to $155.1 million in the same period of 2023, beating the analysts' average estimate of $192.5 million.
Precision oncology revenue also grew 30 percent over Q4 2023, to $184.6 million from $142.2 million, driven by an increase in the volume of both clinical and biopharma tests, which grew 24 percent and 16 percent, respectively, over the prior-year period.
Guardant also attributed the revenue increase to an uptick in the Medicare reimbursement rate for its Guardant360 LDT test to $5,000, which became effective Jan. 1 2024, as well as an increase in both Medicare Advantage and commercial payer reimbursement.
The company's remaining revenue was $17.2 million for the fourth quarter of 2024, up 33 percent from $12.9 million in the same period of 2023. This included both development services revenue and $4.1 million derived from approximately 6,400 Guardant Shield screening tests that the firm reported in the fourth quarter of 2024 after the launch of that new assay.
During a conference call with investors, Guardant Co-CEO AmirAli Talasaz said that the firm continues to expect that it will gain ADLT status designation for Guardant Shield, which would raise Medicare's reimbursement rates from $920 to $1,495.
The majority of the company's revenue from Guardant Shield testing in 2024 came from the Medicare population.
"With the current rate of improvement, we are expecting Shield to be gross margin-positive in its first full year … much sooner than we originally anticipated," Talasaz said. "This gives us flexibility to reinvest in our commercial infrastructure in 2025."
Talasaz also mentioned that Guardant Shield had been selected earlier this year for the National Institutes of Health's Vanguard study in which it will be assessed alongside another methylation-based technology pioneered by ClearNote Health.
"Looking ahead, we are excited about our upcoming milestones in 2025, including presentation of our multi-cancer data [and] the potential inclusion of Shield in the American Cancer Society guidelines," Talasaz added.
Guardant's Q4 net loss was $111.0 million, or $.90 per share, compared to a net loss of $187.0 million, or $1.58 per share, in the year-ago period. Most of the improvement was due to a non-recurring $83.4 million legal accrual recorded in 2023.
On an adjusted basis, the company posted a loss of $.62 per share for Q4 2024, falling short of the consensus Wall Street estimate of a loss of $.50 per share.
The firm's fourth quarter R&D expenses rose about 4 percent to $93.5 million from $89.9 million in Q4 2023. Its SG&A spending was $156.7 million, up 34 percent from $116.8 million
For full-year 2024, Guardant's total revenues were $739.0 million, up 31 percent from $563.9 million in 2023, beating analysts' average estimate of $729.0 million. This included precision oncology revenue of $687.9 million, a 34 percent increase over $514.2 million, again driven by higher test volume and better reimbursement, as well an approximately $22 million non-recurring, out of period revenue upside due to better-than-expected cash collections from prior years.
Development services and other revenue was up 3 percent at $51.1 million compared to $49.7 million in 2023.
Guardant's full-year net loss was $436.4 million, or $3.56 per share for 2024, compared to a net loss of $479.4 million, or $4.28 for the prior year. On an adjusted basis the firm had a loss per share of $2.01 for 2024, short of the consensus Wall Street estimate of loss per share of $1.99.
The company's full year R&D expenses totaled $347.8 million, down about 5 percent from $367.2 million in 2023. Its SG&A costs rose 21 percent to $545.0 million from $451.0 million.
The firm ended 2024 with $525.5 million in cash and cash equivalents, $314.4 million in short-term marketable securities, and $104.2 million in restricted cash.
Guardant Health expects its full year 2025 revenue to be in the range of $850 million to $860 million, representing growth of 15 percent to 16 percent compared to 2024. Within that range, the company predicts oncology test revenue growth of approximately 15 percent year over year and clinical volume growth of approximately 25 percent.
The firm's guidance also calls for screening revenue in the range of $25 to $30 million, driven by the provision of 45,000 to 50,000 Guardant Shield tests.
During the company's conference call, Talasaz said that Guardant is "very pleased" with response from physicians to the Guardant Shield test. Regarding the 2025 guidance, he said the company had around 50 sales representatives in the field when the test launched last August.
"We increased that to 100 as we ended the last year … and it's going to take them some time to contribute … [so] we believe that our ramp rate is going to be more back-ended," he said.