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- **Revenue Beat**: $131.9M (+14% YoY), testing up 17% to $127.8M. Decipher +26%, Afirma +7%.
- **Margin Triumph**: 30.1% EBITDA margin vs. 23.5% guidance, 73% gross margin.
- **Strategic Wins**: 
  - Decipher metastatic launch drives 30% high-risk patient growth.
  - MRD pipeline expands to 10 studies, targeting MIBC and breast.
  - Prosigna LDT mid-2026 with OPTIMA trial data.
- **Financial Health**: $366M cash, 25%+ EBITDA margin target for 2026.
- **Competitive Edge**: Decipher volume +26% QoQ, GRID database 115K slides.
- **Growth Catalysts**: Breast sales team hiring, v2 transcriptome benefits, no SAS drag in 2026.

**【CEO Summary Section】**
- **Revenue Growth**: Total revenue reached $131.9 million, up 14% YoY. Testing revenue grew 17% to $127.8 million, driven by Decipher (+26%) and Afirma (+7%).
- **Profitability**: Adjusted EBITDA margin hit 30.1%, up 650 basis points YoY, exceeding 25% target. Gross margin improved to 73%.
- **Strategic Initiatives**: 
  - Decipher for metastatic prostate cancer launched in June, with 30% volume growth in high-risk localized patients.
  - MRD pipeline expanded with 10 studies in testing, targeting MIBC and breast cancer.
  - Prosigna LDT for breast cancer expected in mid-2026, backed by OPTIMA trial data.

**【CFO Financial Commentary】**
- **Q3 Results**: GAAP net income $19.1 million; Non-GAAP EPS $1.08. Testing ASP $2,925 (-2% YoY) due to lab benefit manager impact.
- **Margin Expansion**: Non-GAAP gross margin 73%, up 150 bps YoY. Operating expenses +2% YoY to $58.6 million.
- **2025 Guidance Update**: 
  - Total revenue raised to $506-510M (+$10M midpoint), testing revenue $484-487M (+$10M).
  - Adjusted EBITDA margin >25% vs. prior 23.5%.
- **2026 Outlook**: Maintain 25% EBITDA target, with v2 transcriptome benefits and no Veracyte SAS drag.

**【Q&A Key Highlights】**
- **Digital Pathology**: Decipher shows weak correlation with DPAI, reinforcing its clinical utility. GRID database now includes 115K slides.
- **MRD Strategy**: TrueMRD targeting 70% of MIBC patients via Decipher channel. NEO-BLAST trial to test de-intensification in MIBC.
- **Breast Expansion**: Hiring breast sales leader; Prosigna launch in mid-2026 with 25% EBITDA margin discipline.
- **Competitive Edge**: Decipher volume up 26% QoQ, outpacing DPAI despite noise. Afirma v2 transition on track for year-end.
- **Cash Flow**: $44.8M cash from ops, $366M cash balance.

**【Operational Updates】**
- **Afirma v2 Transition**: 1/3 of samples on new workflow, reducing RNA input and improving access.
- **Decipher GRID**: 23 new abstracts published, total 240. PORTOS/PTEN signatures launching in Molecular Features Report.
- **MRD Pipeline**: 10 studies in testing, 13 in contracting, 10 in planning across MIBC, CRC, and breast cancer.

Veracyte, Inc. (VCYT) Q3 2025 Earnings Call Transcript

- **Revenue Beat**: Q2 2025 revenue $130 million (+14% YoY), driven by Decipher (+28% volume) and Afirma (+8% volume). Adjusted EBITDA margin 27.5%.
- **Strategic Launches**: Decipher Prostate metastatic launched in June; Prosigna LDT to launch mid-2026; MRD for MIBC to launch H1 2026 with whole genome sequencing.
- **Financial Strength**: $320.7 million cash, 23.5% 2025 EBITDA margin guidance. SAS restructuring saves $13 million vs. 2024, enabling growth investments.
- **Growth Drivers**: Decipher targeting 80% prostate market share; Afirma ASP stabilization; Prosigna 225,000-patient opportunity; MRD expansion to new cancers annually.

**【CEO Summary Section】**
- Q2 2025 revenue reached $130 million, up 14% YoY, driven by 14% growth in testing revenue. Decipher volume grew 28% YoY to 25,500 tests, on track for >100,000 annual tests. Afirma volume increased 8% YoY to 16,950 tests. Adjusted EBITDA margin was 27.5%, exceeding expectations.
- Decipher Prostate metastatic launched in June, with 4 Phase III studies showing benefit of therapy intensification for high-risk patients. Partnership with Helix enables ordering germline cancer tests alongside Decipher. GRID database now includes 225+ publications and 90,000 digital pathology slides.
- Prosigna LDT expected to launch mid-2026 on V2 transcriptome. MRD platform for muscle invasive bladder cancer (MIBC) to launch H1 2026, with whole genome sequencing for clonal evolution monitoring. Percepta Nasal Swab pivotal study nearing completion.

**【CFO Financial Commentary】**
- Q2 2025 testing revenue: $122.3 million (+14% YoY). Testing ASP: $2,881 (-3% YoY) due to prior period collections. Gross margin: 71.5% (up 30bps YoY). Adjusted EBITDA: $35.8 million (27.5% of revenue). Cash from operations: $33.6 million. Ending cash: $320.7 million.
- Updated 2025 guidance: Total revenue $496-504 million (+14-15% YoY). Testing revenue $477-483 million (+14-15% YoY). Adjusted EBITDA margin 23.5% (vs. prior 22.5%). Q3 revenue expected flat YoQ due to SAS biopharma revenue decline.
- SAS restructuring: $15 million total cash outlay, $5 million savings reflected in 2025 guidance. Product revenue to stabilize at $2-2.5 million/Q with contract manufacturing.

**【Q&A Highlights】**
- **Decipher Growth Drivers**: Metastatic launch (10% of prostate cancer incidence) and halo effect on high-risk localized patients. 2025 guide implies 22.5-24% Decipher revenue growth. Long-term confidence in 80% market share. Afirma expected 6-7% revenue growth in 2025, with V2 transcriptome launch mitigating ASP pressure.
- **Prosigna Launch**: Mid-2026 launch with Medicare coverage. OPTIMA trial (4,500 patients) nearing completion. PAM50-based test to compete in 225,000-patient U.S. market. Gross margin similar to Afirma but with histopathology component.
- **MRD Strategy**: Whole genome sequencing for MIBC MRD, leveraging Decipher urology channel. Expansion to new indications annually starting 2027. MolDx reimbursement secured prior to launch. Cross-training reps for academic/community oncology outreach.
- **Financial Discipline**: 2025 R&D/S&M spend up $5 million Q3 vs. Q2. 2026 investments balanced with 25% adjusted EBITDA goal. No share buybacks planned; focused on pipeline growth.

Veracyte, Inc. (VCYT) Q2 2025 Earnings Call Transcript

- **Revenue Growth**: Q1 2025 revenue up 18% YoY to $114.5M, driven by Decipher (+33%) and Afirma (+6%) testing revenue.
- **Decipher Expansion**: 37% YoY volume growth to 22,600 tests, with metastatic launch targeting 30,000 annual diagnoses.
- **New Products**: Prosigna LDT for breast cancer (mid-2026) and MRD for MIBC (H1 2026) add $300M+ addressable market.
- **Profitability**: Adjusted EBITDA margin raised to 22.5% for 2025, reflecting lab efficiency and project spend timing benefits.
- **Pipeline Confidence**: MRD and nasal swab value supported by differentiated evidence generation and execution track record.


**【CEO Summary Section】**
- Q1 2025 total revenue reached $114.5 million, up 18% YoY, driven by testing revenue growth of 19% (Decipher +33%, Afirma +6%).
- Decipher volume grew 37% YoY to 22,600 tests, with broad expansion across biopsy risk categories and record ordering providers (+20% YoY).
- Launched Decipher Prostate for metastatic patients in late April, targeting 30,000 annual diagnoses and expanding into the full prostate cancer risk spectrum.
- Announced Prosigna LDT for breast cancer in mid-2026, leveraging the PAM50 signature for 225,000 eligible U.S. patients annually.
- Progressed MRD platform for muscle invasive bladder cancer (MIBC), with commercial launch expected in H1 2026, and expanded clinical evidence through UMBRELLA trial.
- Completed Afirma assay transition to v2 Veracyte transcriptome in summer 2025 to reduce costs and mitigate tariff impacts.

**【CFO Financial Commentary】**
- Q1 2025 non-GAAP gross margin improved 400bps to 72%, driven by testing margin expansion (+200bps to 74%) and lab efficiency projects.
- Adjusted EBITDA of $24.7 million (21.6% of revenue) exceeded expectations, up from prior guidance of 21.6% for the year.
- Raised 2025 adjusted EBITDA margin guidance to 22.5% (from 21.6%) due to lab efficiency benefits and project spend timing.
- Testing revenue guidance maintained at $470-480 million, with Decipher expected to drive high-single digit Afirma growth and low-double digit Decipher growth.

**【Q&A Key Themes】**
- **Portfolio Optimization**: Management emphasized disciplined portfolio expansion, with MRD and nasal swab pipeline value supported by differentiated evidence generation and execution track record.
- **Organizational Readiness**: Lab capacity expanded for next 5-7 years; commercial teams will scale incrementally with new product launches (e.g., Prosigna LDT).
- **Decipher Metastatic Launch**: Early adoption strong, with full launch in June; expected to complement biopsy testing growth and expand addressable market.
- **MRD Margin Management**: Whole genome sequencing COGS mitigation strategies include sequencing cost reduction projects and Medicare ASP leverage for MIBC indication.
- **SAS Resolution**: Marseille facility closure expected by year-end 2025, with minimal impact on 2025 IVD product development timelines.


Veracyte, Inc. (VCYT) Q1 2025 Earnings Call Transcript

- **Revenue Records**: Q4 2024 revenue up 21% YoY to $119M, full year $446M (+23%). Testing revenue dominates at 95% of business. 
- **Decipher Dominance**: 36% volume growth in 2024, metastatic launch H1 2025. Low-risk prostate cancer now 20% of Decipher volume. 
- **Afirma Expansion**: Bethesda V/VI growth >80% YoY, high-single-digit 2025 revenue growth expected. 
- **MRD & Innovation**: Bladder cancer MRD launch H1 2026, nasal swab study 85% enrolled. France-related costs up to $15M in 2025. 
- **Profitability**: 2025 adjusted EBITDA margin +100bps, cash generation to accelerate post-Q1.

**【CEO Summary Section】**
- **Record Year Performance**: Q4 2024 revenue of $119 million (+21% YoY), full year $446 million (+23% YoY). Testing revenue grew 28% YoY, driven by Decipher (+36% volume) and Afirma (+12% volume). 
- **Decipher Leadership**: 80,000+ tests in 2024 (36% growth), Q4 volume up 45% YoY to 22,400. Low-risk prostate cancer now 20% of Decipher volume. Metastatic indication approved in Q4, expected to launch H1 2025 with volume impact in H2.
- **Afirma Expansion**: Testing revenue up 4% Q4, Bethesda V/VI growth >80% YoY. 65% market penetration with high-single-digit growth expected in 2025.
- **Long-Term Growth Drivers**: MRD platform for bladder cancer (H1 2026 launch), nasal swab study (NIGHTINGALE 85% enrollment), and international IVD strategy (Marseille facility closure risk).

**【CFO Financial Commentary】**
- **Q4 2024 Results**: GAAP net income $5.1 million, adjusted EBITDA $26.1 million (22% margin). Full year cash generation $70 million. 
- **2025 Outlook**: Testing revenue $470-480 million (+12-15% YoY), adjusted EBITDA margin +100bps. France-related costs up to $15 million in 2025, with $13 million annual savings if SAS sold.
- **Margins & Costs**: Non-GAAP gross margin 69.3%, operating expenses flat YoY at $57.9 million. 2025 tax rate mid- to high-single digits.

**【Q&A Key Themes】**
- **Decipher Growth**: 40% market penetration, 65%+ share. 2025 volume growth driven by localized disease expansion and metastatic launch. 
- **France Business Risk**: SAS operating loss $5M/Q, potential $15M one-time costs in 2025. Prosigna supply continuity dependent on finding buyer. 
- **MRD Platform**: Whole genome sequencing approach, H1 2026 launch for bladder cancer. MolDx tech assessment submitted, reimbursement prioritized. 
- **Afirma Strategy**: High-single-digit growth via volume, limited ASP tailwind. Expanded LCD benefit to materialize in 2025.

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