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CAREDX INC earnings calls

CDNA · every analyst question and management's answer

Oct 29, 2026 earnings call — NavDx integration and transplant growth

Revenue $139 million, up 39%, and full-year 2026 revenue guidance raised to $520 million to $530 million.

Revenue $0.1B (est $0.1B) · EPS $0.70 (est $0.25) · Next-quarter revenue outlook $0.1B

Key quotes

"We continue to advance AlloHeme, our recurrence monitoring test for patients undergoing cell therapy to treat AML and MDS hematologic malignancies."

— John Hanna (CEO) · Pipeline and launches

"At ASTRO, more than 20 trials were highlighted exploring radiation deescalation in this setting, underscoring the level of clinical interest in determining which patients may safely receive a lower dosage."

— John Hanna (CEO) · Evidence generation

"On October 1, we moved NavDx onto our CareDx billing platform and brought in-house 100% of our RCM workflows, creating a more scalable operational foundation."

— John Hanna (CEO) · NavDx integration and RCM

Analyst Q&A 8

LCD impact and NavDx price

Q (Kyle Mikson · Canaccord Genuity): The analyst asked how the August LCD payment decision has changed physician behavior, testing frequency, and patient penetration and how that affects volume and revenue in 2027. He also asked about NavDx ASP upside versus being just a volume story next year.

A: Management said the LCD was a payment policy and has not hurt utilization; volumes have continued to grow year-over-year and quarter-over-quarter. They said the LCD overhang is removed so they can refocus on clinical differentiation and workflow. Management also said NavDx was put on their billing system on October 1, they see opportunity for price appreciation to $1,000 or higher, and the Medicare price is $1,800.

"We said all along that the LCD was a payment policy and really would not impact utilization in the field." — John Hanna (CEO)

Transplant protocols and organ growth

Q (Mark Massaro · BTIG): He asked for more detail on protocol adoption, organ-by-organ performance (kidney, lung, heart), how many transplant centers are on protocols, and whether surveillance or for-cause testing has lifted volumes.

A: Management said the quarter was strong and adoption is growing into a real standard of care for transplantation patients, with continued growth in surveillance protocols across kidney, lung, and heart. They said kidney grew well over 20% year-over-year, lung had a very strong quarter, and heart continues to grow in the mid-teens. They also noted 17% year-over-year midpoint growth in volumes and that mix is about 45% kidney, 45% heart and 10% lung.

"And we think that, that's going to continue because the adoption of this testing is growing into a real standard of care in clinical practice for transplantation patients." — John Hanna (CEO)

EBITDA drivers and ASP runway

Q (Jefferies): The analyst asked what drove the step-up in EBITDA margin and whether any specific cost or leverage items stood out. He also asked about long-term transplant ASP runway and near-term actions to improve ASPs.

A: Management said OpEx stayed at around $75 million from Q2 to Q3 and they had about $1.5 million of transaction-related spend in Q3. They said expense control and revenue cycle improvements are translating to rising margins, positive net income all 3 quarters this year, and strong cash flow from operations. On ASPs, they reiterated a 3-year target of $2,000 per test for solid organ transplant and said they are working toward it, noting $1,550 in Q4 as a reference point.

"Well, as you see, our OpEx has stayed at around $75 million from Q2 to Q3, and we had about $1.5 million of spend in Q3 related to the transaction." — Keith Kennedy (CFO)

For-cause vs surveillance and AlloHeme timing

Q (William Bonello · Craig-Hallum): He asked whether the team is promoting expanded use cases across care instead of fixed protocol targets and whether for-cause testing opportunity is as large as surveillance. He also asked the plan and milestones for AlloHeme coverage.

A: Management said it's both: some centers use no molecular testing, some use only for-cause, and they are building belief to make testing standard of care across use cases including therapeutic decisions and reducing biopsies. For AlloHeme they said the first priority is publication of the clinical validation study ACROBAT, they are completing CLIA readiness work in 2026, plan to submit analytical and clinical data in 2027 for coverage, expect coverage likely in '28, and anticipate significant revenues in 2029.

"First and foremost is publication of the clinical validation study, the ACROBAT trial." — John Hanna (CEO)

AlloHeme launch and Epic integration

Q (Mason Carrico · Stephens): He asked if they will gate volumes for AlloHeme ahead of Medicare coverage and whether AlloHeme will be orderable through Epic Aura at launch where Epic Aura is live.

A: Management said they do not plan to gate volume because they believe AlloHeme will be a standard of care and will change how AML and MDS patients are monitored; they will target top KOL centers with a limited field team at launch. They also said the product will launch natively on Epic Aura so 100% of ordering should go through EMR integration on day 1.

"I don't think we're going to gate volume because for me, I believe this product will be a standard of care and is going to significantly change the way AML and MDS patients are monitored." — John Hanna (CEO)

HistoMap resourcing and NavDx evidence

Q (Matthew Larew · William Blair): He asked how much the company will leverage existing teams for HistoMap and AlloHeme in 2027, and what 2027 will look like for NavDx evidence generation and key milestones toward coverage and commercial expansion.

A: Management said HistoMap extends their kidney solution and will be promoted by the same AlloSure Kidney field team so it does not require added resources; they described HistoMap as not a huge market. They said NavDx is commercially available and being used broadly in head and neck cancer, that they are supporting many clinical studies including radiation deescalation Phase II trials, and they expect more clinicians to use NavDx in 2027 as interest grows.

"NavDx is commercially available. It's being utilized broadly in the head and neck cancer space." — John Hanna (CEO)

Modeling 2027 growth and ASPs

Q (H.C. Wainwright): She asked for a bridge of the revenue guidance increase among transplant volume, current reimbursement, NavDx, and prior period collections and what current revenue-per-test assumptions to carry into 2027 modeling.

A: Management said they are not providing 2027 guidance today but pointed to their prior 3-year plan: grow solid organ transplant by 15% year-over-year. They also said NavDx was expected to grow 30% to 40% for the next 2 years through 2027 and advised modelers to use Q4 ASP guidance for each product and hold it steady through 2027.

"We're not providing 2027 guidance today, but what I would point you to is previously in -- when we provided a 3-year long-range plan, we said that we would grow our solid organ transplant business by 15% year-over-year." — John Hanna (CEO)

Data platform and AI role

Q (Kyle Mikson · Canaccord Genuity): He asked how CareDx's data and platforms could play a role in training AI models beyond oncology, given their transplant data and partnerships like with 10x for ImmuneScape, and what that could mean outside traditional testing.

A: Management said they have an extensive database in solid organ transplant with molecular test data, EMR utilization data, and software tools. They described a platform called VANTx that supports clinicians with models and said they are starting to plan a similar platform approach in specialty oncology and will provide more detail in early '27.

"We certainly have an extensive database in solid organ transplant, including molecular information on the tests that we performed." — John Hanna (CEO)

AI-generated notes on the earnings call transcript. Quotes are taken from the transcript. This is not a FolioObs investment view.

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