Original from: businesswire
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics, reported financial results for the quarter and full year ended December 31, 2022.
Fourth Quarter 2022 Financial Highlights
- Revenue of $126.9 million for the fourth quarter of 2022, an increase of 17% over the fourth quarter of 2021.
- Reported 36,000 tests to clinical customers and 8,200 tests to biopharmaceutical customers in the fourth quarter of 2022, representing an increase of 41% and 24%, respectively, over the fourth quarter of 2021.
Full Year 2022 Financial Highlights
- Revenue of $449.5 million for the full year 2022, an increase of 20% over the full year 2021.
- Reported 124,800 tests to clinical customers and 26,000 tests to biopharmaceutical customers in the full year 2022, representing an increase of 42% and 40%, respectively, over the full year 2021.
Recent Highlights
- Demonstrated 83% sensitivity and 90% specificity in pivotal ECLIPSE study evaluating Shield for colorectal cancer detection. Separately, Guardant Shield LDT has shown greater than 90% adherence in real world settings.
- Announced FDA approval for Guardant360 CDx as companion diagnostic for ORSERDU for treatment of patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer.
- Obtained coverage for Guardant360 CDx tests in lung and breast cancer from United Healthcare.
- Introduced Guardant Galaxy suite of advanced AI analytics in partnership with Lunit to enhance our portfolio of cancer tests starting with the Guardant360 TissueNext PD-L1 test, shown to improve biomarker detection by >20% in NSCLC.
¡°2022 marked another year of great progress at Guardant Health. We achieved record revenues and volumes during the year, launched new offerings in minimal residual disease with multi cancer Reveal and expanded market access for our tests. We also launched our Smart Liquid Biopsy platform, which we believe will drive the next chapter of growth for our oncology business and enable significant R&D efficiency and operating leverage. With the approval of our first companion diagnostic in breast cancer and expanded payor coverage, we are poised for continued strong growth in the year ahead,¡± said Helmy Eltoukhy, co-founder and co-CEO.
¡°In December, we reported successful results in our pivotal ECLIPSE study for colorectal cancer screening with 83% sensitivity at 90% specificity. With over 90% of individuals completing the blood-based screening test, Shield significantly improves adherence rates and adds an important new option for patients and healthcare providers to boost screening rates, detect more cancers and save countless lives,¡± said AmirAli Talasaz, co-founder and co-CEO. ¡°We intend to complete our submission to FDA in the first quarter of 2023 as we continue our research and development efforts in screening for lung and additional cancers.¡±
Fourth Quarter 2022 Financial Results
Revenue was $126.9 million for the three months ended December 31, 2022, a 17% increase from $108.1 million for the three months ended December 31, 2021. Precision oncology revenue grew 28%, driven predominantly by an increase in clinical testing volume and biopharma sample volume, which grew 41% and 24%, respectively, over the prior year period. Development services and other revenue decreased by 33%, primarily due to a one-time catch-up royalty payment that was recognized in the fourth quarter of 2021.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $79.8 million for the fourth quarter of 2022, an increase of $5.1 million from $74.7 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 63%, as compared to 69% for the corresponding prior year period.
Operating expenses were $225.9 million for the fourth quarter of 2022, as compared to $172.9 million for the corresponding prior year period, an increase of 31%. Non-GAAP operating expenses were $201.2 million for the fourth quarter of 2022, as compared to $146.2 million for the corresponding prior year period.
Net loss attributable to Guardant Health, Inc. common stockholders was $139.9 million for the fourth quarter of 2022, as compared to $90.9 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $1.36 for the fourth quarter of 2022, as compared to $0.89 for the corresponding prior year period. Non-GAAP net loss was $119.6 million for the fourth quarter of 2022, as compared to $70.4 million for the corresponding prior year period. Non-GAAP net loss per share was $1.17 for the fourth quarter of 2022, as compared to $0.69 for the corresponding prior year period.
Adjusted EBITDA loss was $109.8 million for the fourth quarter of 2022, as compared to a $64.6 million loss for the corresponding prior year period.
Full Year 2022 Financial Results
Revenue was $449.5 million for the year ended December 31, 2022, a 20% increase from $373.7 million for the year ended December 31, 2021. Precision oncology revenue grew 29%, driven predominantly by an increase in clinical testing volume and biopharma sample volume, which grew 42% and 40%, respectively, over the prior year period. Development services and other revenue decreased by 17%, primarily due to the change in collaboration projects with biopharmaceutical customers for companion diagnostic development and regulatory approval services, and discontinuation of our Guardant-19 tests in August 2021, partially offset by revenues earned from licensing our technologies, and providing data services during the year ended December 31, 2022.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $293.2 million for 2022, an increase of $42.5 million from $250.7 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 65%, as compared to 67% for the corresponding prior year period.
Operating expenses were $837.6 million for 2022, as compared to $661.7 million for the corresponding prior year period, an increase of 27%. Non-GAAP operating expenses were $736.6 million for 2022, as compared to $506.8 million for the corresponding prior year period.
Net loss attributable to Guardant Health, Inc. common stockholders was $654.6 million for 2022, as compared to $405.7 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $6.41 for 2022, as compared to $4.00 for the corresponding prior year period. Non-GAAP net loss was $435.4 million for 2022, as compared to $251.7 million for the corresponding prior year period. Non-GAAP net loss per share was $4.26 for 2022, as compared to $2.48 for the corresponding prior year period.
Adjusted EBITDA loss was $403.4 million for 2022, as compared to a $231.5 million loss for the corresponding prior year period.
Cash, cash equivalents and marketable debt securities were $1.0 billion as of December 31, 2022.
2023 Guidance
Guardant Health expects full year 2023 revenue to be in the range of $525 million to $540 million, representing growth of 17% to 20% compared to full year 2022.
We expect full year 2023 operating expenses to be below full year 2022, and free cash outflow to be approximately $350 million in 2023.
About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.
