Profitability & Cash
Q: Future margin leverage and cash deployment?
A: Management emphasized that the specialty diagnostics model remains highly leverageable—with a goal of a sustainable 25% adjusted EBITDA margin—and they’re deploying cash conservatively to fund long‐term growth initiatives and evidence development.

Testing Growth
Q: How will testing volumes grow in 2025?
A: They expect robust growth driven by Afirma’s high single‐digit revenue gains and an expanded Decipher market—especially with metastatic testing coming online—to build on nearly 36% year-over-year gains.

Decipher Expansion
Q: What fuels Decipher’s adoption and metastasis potential?
A: Management noted that Decipher’s growing adoption is propelled by strong clinical evidence and updated NCCN guidelines, with an anticipated 10% market benefit from metastatic patients as new testing ramps up, without immediate ASP pressure.

Pricing Trends
Q: What’s driving recent pricing improvements?
A: They credit best-in-class managed care and billing teams that have driven effective price increases—benefiting from prior period collections—with expectations that the curve will eventually flatten from extraordinary step changes.

Commercial Payer Mix
Q: How stable are commercial payer contracts?
A: Management reported that Decipher is roughly 60% Medicare/Medicare Advantage while Afirma has a larger commercial footprint, and they continue to secure new contracts given the strong evidence base of their tests.

Salesforce Productivity
Q: How quickly do new reps become productive?
A: They typically see new sales reps become fully productive within about 6 months, reflecting a measured and steady ramp-up in both Decipher and Afirma teams.

IVD Timeline
Q: What’s the update on IVD product launches?
A: The pipeline is progressing with Decipher PCR and Prosigna NGS expected to launch next year, followed by a nasal swab product later, as they fine-tune supply chain readiness.

MRD Test Launch
Q: When will the MRD test launch generate revenue?
A: The MRD assay, starting in the bladder cancer indication, is on track for a first-half 2026 launch, serving as a proof of concept for broader platform expansion over time.

Product Revenue Decline
Q: Why did product revenue drop this quarter?
A: Management attributed the 21% decline to ongoing supply challenges and a deliberate decision to manage demand, which will lead to muted product revenue growth going forward.

Milestone Payments
Q: What’s behind the $10–15M Q4 cash impact?
A: They clarified that the Q4 cash guidance includes a milestone payment of around $5M, anticipated CAPEx and some working capital adjustments—reflecting expense-side planning rather than revenue opportunities.

Study Enrollment Timing
Q: When will the NIGHTINGALE study complete enrollment?
A: Management has stopped providing a specific timeline, noting that while enrollment continues robustly—with nearly 100 sites—predicting completion remains challenging.

Bethesda V Mix
Q: How does Bethesda V affect Afirma volume?
A: Bethesda V currently represents about 5–10% of total Afirma test volume, offering a modest tailwind in both volume and ASP as commercial and Medicare segments are balanced.

Guideline & Companion
Q: Will guidelines boost companion diagnostic use?
A: They anticipate that growing inclusion in clinical guidelines—supported by robust studies like STAMPEDE—will enhance Decipher’s role, potentially evolving into a companion diagnostic that aids treatment decisions globally.

Hurricane Impact
Q: Were there lasting hurricane impacts this quarter?
A: Management observed only a minor, transient dip in shipments—roughly a day’s volume—and confirmed that operations recovered quickly without significant disruption.