This article was updated with comments Myriad executives made during an earnings call Thursday afternoon.
NEW YORK – Myriad Genetics on Thursday morning said its total revenues during the first quarter of 2022 decreased 5 percent, but the firm beat the consensus Wall Street estimates on the top and bottom lines.
For the three months ended March 31, the firm reported total revenues of $164.9 million, down from $173.1 million in Q1 2021. On average, analysts had projected Q1 revenues of $156.6 million.
All of Myriad's Q1 revenues came from its molecular diagnostics business, which increased 3 percent compared to $159.6 million during Q1 last year. The Salt Lake City-based firm did not record any revenues from its pharmaceutical and clinical service segment during the quarter compared to $13.5 million in the prior year's quarter.
Within the molecular diagnostics category, revenues from its hereditary cancer tests MyRisk, BRACAnalysis, and BRACAnalysis CDx were down 7 percent at $70.9 million compared to $76.1 million in Q1 2021. GeneSight pharmacogenetic testing revenues grew 66 percent to $29.3 million from $17.6 million. In the prenatal segment, revenues from ForeSight and Prequel grew 35 percent to $31.9 million from $23.7 million. In the tumor profiling segment, revenues from MyChoice CDx, Prolaris, and EndoPredict increased 5 percent to $32.5 million from $31.0 million. The autoimmune Vectra DA test, which Labcorp said it would buy last year, contributed $300,000, a 97 percent decline compared to $10.7 million last year, while tests in Myriad's "other" segment did not contribute any revenues in Q1, compared to $500,000 in Q1 2021.
"We continue to execute on our transformation and growth plan with strong commercial demand for new offerings like our recently launched suite of Precise Oncology Solutions," Myriad President and CEO Paul Diaz said in a statement, highlighting that the GeneSight test "reached one of its highest quarterly volume levels" and products in the women's health segment generated double-digit year-over-year revenue growth in Q1.
The firm recorded diagnostic test volumes of 241,000 in Q1 2022, a 10 percent increase from the prior year's quarter, excluding test volumes from divested assets related to Vectra DA and MyPath Melanoma.
"Our hereditary cancer testing business was hit the hardest by COVID-19 and its variants in the first six weeks of the quarter," and negatively impacted test volumes due to test access constraints and staffing shortages, Myriad CFO Bryan Riggsbee said during a call to discuss the company's financial performance. On a positive note, he highlighted that the Prolaris prostate cancer test "exited the first quarter with a record-breaking number of tests ordered in March."
Myriad reported a net loss attributable to its shareholders of $20.5 million, or $.26 per share, compared to a net loss of $39.5 million, or $.52 per share, in Q1 2021. Adjusted loss per share was $.03, below the average Wall Street estimate of $.07.
The firm's fourth quarter R&D expenses declined 9 percent to $21.2 million from $23.1 million, and its SG&A spending declined 24 percent to $110.6 million from $146.4 million.
Myriad also announced earlier this week that next year it will add a new liquid biopsy therapy selection test — Illumina's TruSight Oncology 500 ctDNA assay — as part of the suite of products oncologists can access through its partnership with Salt Lake City-based Intermountain Healthcare. The molecular diagnostics firm and healthcare system together launched the Precise Oncology Solutions service in Q1 to enable oncologists to simultaneously order Myriad's MyRisk Hereditary Cancer Test for assessing patients' inherited risk for eight cancers; Myriad's MyChoice CDx and BRACAnalysis CDx for identifying patients with BRCA1/2 mutations and other DNA repair deficiencies that make them more likely to respond to PARP inhibitors; and Intermountain's Precise Tumor Molecular Profile Test that assesses more than 500 genes.
The partners will add the TruSight Oncology 500 ctDNA assay to the Precision Oncology Solutions service offerings in 2023, initially for assessing hereditary breast, ovarian, prostate, and pancreatic cancer risk and for helping guide treatment decisions for patients with advanced solid tumors. However, in the future, Myriad is planning to add other liquid biopsy and companion testing options, such as the ability to assess measurable residual disease (MRD).
Diaz said during the call that Myriad has decided to internally develop an MRD test after exploring a range of options, including M&A. "Myriad's current workflow, coupled with our technologies and commercial capabilities gives us the best opportunity to have a market leading MRD test that serves the current and emerging needs of healthcare providers," he said, noting that the goal is to develop bespoke MRD assays for patients based on the mutations in their tumors, which then can be used for monitoring cell-free DNA for signs of cancer relapse after surgical resection.
The Salt Lake City-based firm is developing a prototype in-house that it expects to launch with pharma partners in 2023 and use it in studies to gather the necessary validation data for a commercial test. To develop the pre-operative tumor assessment part of the MRD test, Myriad will use the validated tumor/normal sample prep, sequencing, and bioinformatics processes already in place for its US Food and Drug Administration-approved MyChoice CDx tumor sequencing test. For the post-operative MRD monitoring aspects, the firm will rely on the cell free DNA isolation and targeted NGS testing methods that it uses for its prenatal screening tests.
By developing the MRD test in-house, Diaz said Myriad hopes to develop a differentiated, competitive product at a fraction of the cost competitors have paid to acquire assets in this market. But it will enter a crowded market featuring products from Natera, Inivata, and Invitae (which acquired its MRD test through its acquisition of ArcherDx).
Myriad ended the quarter with $165.2 million in cash and cash equivalents and $103.2 million in marketable investment securities.
Diaz said that the firm is confident that the investments Myriad made in new technological capabilities, product enhancements and product rollouts in Q1 will "significantly improve the company’s competitive position and will accelerate growth in the second half of 2022 and 2023."
The firm reiterated that it expects full-year revenues in 2022 to be in the range of $670 million to $700 million and adjusted EPS in the range of $.00 to $.20.