Personalis, Inc. Q3 FY2025 earnings call

Clinical Volume and Growth: Delivered 4,388 clinical tests, a 26% sequential and 364% year-over-year growth. Over 700 physicians are ordering NeXT Personal. ### Reimbursement Efforts: Submitted lung cancer for coverage, with 3 dossiers under review by MolDX, targeting 2 coverage decisions in 2025. ### Biopharma Partnerships: Utilizing ultrasensitive NeXT Personal test in Phase III studies, launched CATE clinical trial for breast cancer, and signed 2 major prospective clinical trials. The underlying demand for MRD is strong, and clinical adoption is compounding.

In Q3, Personalis delivered $14.5 million in revenue. Clinical revenue was $0.4 million, while biopharma revenue was $13.2 million. Biopharma revenue accounted for a significant portion of the total, with clinical revenue being a smaller component. The 4,388 clinical tests represented a 26% sequential and 364% year-over-year growth, with over 700 physicians ordering NeXT Personal.

Full-Year Revenue: Revised to $68 million to $73 million. ### Pharma Tests and Services: Expected to be in the range of $50 million to $54 million. ### Population Sequencing: In the range of $16.5 million to $17 million. ### Clinical Revenue: Reduced to $1.5 million to $2 million. ### Gross Margin: Expected to be 22% to 24%. ### Net Loss: Approximately $85 million. ### Cash Usage: Approximately $75 million, unchanged from prior guidance.

Logistical Delays: Biopharma sample shipments have faced challenges, possibly related to government shutdown, causing variability in Q4 revenue. Some samples have had issues with customs, leading to potential slips into Q1 if not resolved in time.

Q: Thomas Flaten asked about large customers that were on the cusp of coming online.

A: Chris Hall said both customers are online, one was a big driver of Q3 numbers, and the other had revenue in Q3 and will bleed into Q4. Also, 2 large prospective clinical trials with biopharma customers were signed.

Q: Mark Massaro asked about NeXT Personal growth being shy of 30%-40% quarterly growth.

A: Chris Hall said they were thoughtful in managing investment, seasonality affects clinical volume, but they are on track to meet year-end targets.

Q: Mark Massaro asked about guidance on clinical revenue and MolDX.

A: Chris Hall said MolDX reviews are active, 3 dossiers are under review, and they are on track to get 2 coverage decisions by year-end.

Q: Daniel Brennan asked about government shutdown impact on MolDX.

A: Christopher Hall said they haven't seen impact yet, MolDX is a private company with a contract and seems to be working well.

Q: Daniel Brennan asked about MolDX review cadence.

A: Richard Chen said there's a 2-month cycle for back and forth with questions and responses.

Q: Thomas VonDerVellen asked about large pharma customers and pipeline.

A: Christopher Hall said account size is expected to increase as the business scales, and they are early in penetrating large biopharma accounts.

Q: Michael Matson asked about TRACERx trial publication and colorectal dossier.

A: Richard Chen said TRACERx study should be published in the next quarter, and CRC is still early in the journey for dossier submission.

Q: John Wilkin asked about molecular volume growth and feedback from Tempus.

A: Christopher Hall and Aaron Tachibana said they were thoughtful with volume to balance margin dilution, retention is high, and feedback from Tempus is positive.

Q: Arthur He asked about drivers of clinical test growth.

A: Christopher Hall said growth is from both increasing physician numbers and getting more tests per physician from existing accounts.