What were the key takeaways from Personalis’s earnings call?

What were the key takeaways from Personalis's earnings call?

What factors drove the changes in Personalis's revenue and profit?

What does Personalis do and what are its main business segments?

What is the market's earnings forecast for Personalis next quarter?

What is Personalis's gross profit margin?

What guidance did Personalis's management provide for the next earnings period?

What is Personalis's latest dividend and current dividend yield?

- **Clinical Volume Surge**: 364% YoY growth to 4,388 tests, 700+ physicians ordering NeXT Personal.
- **MolDX Milestones**: 3 dossiers under review, targeting 2 approvals by year-end.
- **MRD Revenue Growth**: 300% YoY biopharma MRD revenue, 1/3 of Q3 biopharma from MRD.
- **Financial Challenges**: $14.5M revenue (44% YoY decline), 13.2% gross margin, $85M net loss guidance.
- **Strategic Focus**: Ultrasensitive MRD leadership, clinical adoption, and reimbursement expansion.

**【CEO Summary Section】**
- Q3 clinical test volume reached 4,388, up 26% sequentially and 364% year-over-year, driven by partnerships like Tempus and direct physician orders.
- Submitted lung cancer for MolDX coverage, bringing total dossiers under review to 3, targeting 2 approvals by year-end.
- Biopharma MRD revenue grew 300% YoY, with 1/3 of Q3 biopharma revenue from MRD projects.
- Clinical evidence highlights include NeXT Personal's lead time advantage in detecting MRD progression (5+ months ahead of imaging) and superior sensitivity in Phase III trials.

**【CFO Financial Commentary】**
- Total revenue $14.5M (44% YoY decline), driven by $4.6M loss from Natera wind-down and $2.5M biopharma delays.
- Gross margin 13.2% (down 20.8% YoY) due to unreimbursed clinical test costs; long-term margin target >50% post-reimbursement.
- Operating expenses $25.2M (9% YoY increase), with 60% growth in sales expenses to support clinical adoption.
- Updated FY25 guidance: $68-73M revenue (down from $70-80M), $130M+ cash at year-end, and $85M net loss.

**【Q&A Key Highlights】**
- **Biopharma Delays**: Q3 sample customs issues caused $2.5M revenue shortfall; expect resolution in Q4/Q1.
- **Clinical Growth Management**: 26% Q3 test growth vs. 30-40% target due to prudent volume pacing ahead of reimbursement.
- **MolDX Progress**: 3 dossiers (breast, IO, lung) in review; anticipate 2 approvals by year-end despite government shutdown risks.
- **MRD Biopharma Demand**: 2 new prospective trials signed in Q3, with >$5M+ pipeline per customer.
- **Long-Term Outlook**: Target $20B+ MRD market share; gross margin >50% post-reimbursement, with 2026+ revenue ramp from biopharma and clinical adoption.

Personalis, Inc. (PSNL) Q3 2025 Earnings Call Transcript

- **Clinical Growth Accelerates**: 59% QoQ test volume growth to 3,478, driven by Tempus partnership expansion to CRC. 600+ physicians now ordering NeXT Personal.
- **Revenue Guidance Adjusted**: Full-year $70M-$80M reflects biopharma delays, but MRD biopharma revenue on track for 300%-400% YoY growth.
- **Reimbursement Priority**: Tightening clinical guidance to $3M-$6M, but confident in securing 2 Medicare indications by year-end.
- **Cash Strength**: $173M cash runway supports clinical scale-up; no immediate capital raise needed.

**【CEO Summary Section】**
- **Clinical Momentum**: Delivered 3,478 NeXT Personal tests in Q2, a 59% sequential increase, with over 600 ordering physicians. Expanded partnership with Tempus to include colorectal cancer (CRC), driving 30%-40% quarterly growth.
- **Revenue Update**: Q2 revenue $17.2M, down 24% YoY due to biopharma delays. Full-year guidance revised to $70M-$80M, reflecting project timing variability and Medicare reimbursement progress.
- **Strategic Focus**: 300%-400% YoY growth in MRD biopharma revenue, targeting $5M+ from 2 new customers. Medicare coverage for 2 indications expected by end-2025.

**【CFO Financial Commentary】**
- **Revenue Breakdown**: Biopharma $11.1M (16% YoY decline), clinical $0.5M (5x YoY). Gross margin 27.6% (down 8% YoY due to unreimbursed clinical costs).
- **Cost Management**: Operating expenses $26.6M (7% YoY increase). R&D $12.4M, SG&A $14.2M. Net loss $20.1M (65% YoY increase).
- **Cash Position**: $173.2M cash, with $75M expected 2025 cash usage for clinical scale-up and studies.

**【Q&A Highlights】**
- **Clinical Reimbursement**: Tightened clinical revenue guidance to $3M-$6M (from $3M-$10M), expecting 2 Medicare indications by end-2025. Tempus partnership drives CRC adoption, with 12-15 field reps added by year-end.
- **Biopharma Challenges**: $10M+ revenue delay in translational research due to industry-wide R&D cuts. MRD growth resilient, with 300%-400% YoY expansion.
- **Cash Flow Outlook**: No immediate need for capital raise; targeting cash flow breakeven post-reimbursement. Gross margin to expand >50% with scale and reimbursement.

Personalis, Inc. (PSNL) Q2 2025 Earnings Call Transcript

- **Revenue Momentum**: Q1 2025 revenue $20.6M (+6% YoY), biopharma segment up 39% to $13.6M.
- **Ultra-Sensitive MRD Differentiation**: 100% recurrence detection in CRC study, 40% results in ultra-sensitive range.
- **Reimbursement Roadmap**: Targeting two Medicare approvals in 2025, breast cancer submission filed.
- **Cash Position Strength**: $185.7M cash, supporting $75M 2025 investment in clinical scale-up.
- **Biopharma Expansion**: 300-400% MRD revenue growth, two new $5M+ annual customers secured.


**【CEO Summary Section】**
- Q1 2025 revenue reached $20.6 million, driven by 39% YoY growth in biopharma revenue to $13.6 million and 52% sequential increase in molecular tests to 2,184.
- Highlighted ultra-sensitive MRD test (NeXT Personal) performance in colorectal cancer (CRC), detecting 100% of recurrences pre-imaging, including distant metastases.
- Reaffirmed 2025 guidance of $80-90 million revenue, targeting reimbursement for at least two indications (breast, lung cancer) by year-end.
- Collaborated with Tempus' 200-person sales force to accelerate clinical adoption, with 40% of MRD-positive results in ultra-sensitive range.

**【CFO Financial Commentary】**
- Q1 2025 total revenue: $20.6 million (+6% YoY), with biopharma segment contributing 66%.
- Gross margin improved to 35% (vs. 28.1% YoY), driven by favorable customer mix; adjusted gross margin (excluding unreimbursed clinical costs) reached 43%.
- Net loss widened to $15.8 million due to $20 million in unreimbursed clinical test costs, but cash reserves remained strong at $185.7 million.
- Full-year 2025 guidance: $80-90 million revenue, 22-24% gross margin, and $83 million net loss.

**【Q&A Key Highlights】**
- **Reimbursement Progress**: Confident in securing at least two Medicare submissions by year-end, with breast cancer submission already filed.
- **Market Competition**: Differentiated by ultra-sensitivity (detecting 1 fragment in 1 million) and ability to confirm negative MRD results, reducing false negatives.
- **CRC Expansion**: VICTORI study interim data shows 87% of recurrences detected in 2-8 week window, positioning for future reimbursement pursuit.
- **Biopharma Growth**: 300-400% YoY MRD revenue growth from biopharma, with two new $5M+ annual customers secured.
- **Cash Usage**: $75 million for 2025, focused on clinical evidence generation and commercial infrastructure build-out ahead of reimbursement.


Personalis (PSNL)-6 May 25-2025 Q1 Earnings call transcript

- **15% Revenue Growth**: 2024 revenue of $84.6M driven by Moderna collaboration and biopharma expansion.
- **30-40% Test Volume Growth**: Q4 2024 MRD tests up 52% to 1,441; targeting 30-40% quarterly growth.
- **2+ Medicare Approvals**: On track for 2025 reimbursement in breast, lung, and IO therapy monitoring.
- **$85M Net Loss Guidance**: 2025 financials reflect investment in clinical scale ahead of reimbursement.
- **90%+ Physician Retention**: High reorder rate underscores clinical value of ultra-sensitive MRD testing.


**【CEO Business Highlights】**
- **Revenue Growth**: Full year 2024 revenue of $84.6M (+15% YoY), driven by biopharma growth (+60% YoY) from Moderna's Phase 3 melanoma trial. 
- **Strategic Partnerships**: Extended 10-year agreement with Moderna for neoantigen therapy development; $50M strategic investment from Merck to deepen collaboration.
- **Clinical Momentum**: 1,441 MRD tests in Q4 (+52% QoQ), targeting 30-40% quarterly growth until reimbursement. 40%+ results in ultra-sensitive range (<100ppm ctDNA).
- **Reimbursement Progress**: Submitted Medicare coverage for breast cancer MRD testing; expect 2+ indications approved in 2025.
- **Pipeline Expansion**: 20+ clinical studies underway across breast, lung, and IO therapy monitoring. PREDICT study enrolling 180+ early-stage breast cancer patients.

**【CFO Financial Summary】**
- **Q4 2024 Results**: 
  - Revenue: $16.8M (-15% YoY) due to Natera volume decline
  - Gross Margin: 27.1% (26.5% YoY improvement)
  - Net Loss: $16.4M (-38% YoY)
- **Full Year 2024**: 
  - Revenue: $84.6M (+15% YoY)
  - Gross Margin: 31.7% (24.8% YoY improvement)
  - Net Loss: $81.3M (-25% YoY)
- **2025 Guidance**: 
  - Revenue: $80-90M (midpoint +31% YoY)
  - Gross Margin: 21-23% (down 900bps YoY due to unreimbursed test costs)
  - Net Loss: ~$85M
  - Cash Usage: $75-80M (vs $46.8M in 2024)
  - Cash Balance: $185M as of Q4 2024

**【Q&A Key Takeaways】**
- **Customer Retention**: 90%+ reorder rate among 300+ active oncologists using NeXT Personal.
- **Reimbursement Timing**: 2+ Medicare submissions expected in 2025; breast cancer paper already accepted for publication.
- **Capital Needs**: No immediate plans to raise additional capital; current cash sufficient to fund clinical ramp.
- **Enterprise Risk**: Natera-related revenue decline of ~$20M in 2025 offset by biopharma growth.


Personalis (PSNL)-27 Feb 25-2024 Q4 Earnings call transcript

Personalis (PSNL)-6 Nov 24-2024 Q3 Earnings call transcript

Personalis (PSNL)-7 Aug 24-2024 Q2 Earnings call transcript

Personalis (PSNL)-8 May 24-2024 Q1 Earnings call transcript

- **Revenue Growth**: 2023 revenue $73.5 million (+13%), 2024 guidance $73-75 million. Biopharma partnerships and Tempus collaboration key to 2025 $100 million target.
- **MRD Strategy**: NeXT Personal early access program exceeds targets, 250+ patients monitored. Medicare submissions for breast, lung, and IO therapy monitoring in 2024.
- **Financial Discipline**: $35 million expense reduction, 2-year cash runway. Gross margin improving to low 30s by 2025 with scale.
- **Partnership Impact**: Tempus salesforce to accelerate MRD adoption, Moderna trial driving biopharma growth. Tempus deal potential $30 million if milestones met.

**【CEO Summary Section】**
- **2023 Performance**: Revenue of $73.5 million, up 13% YoY, driven by biopharma and VA MVP growth. Reduced annual expenses by $35 million, extending cash runway to Q1 2026.
- **2025 Target**: $100 million revenue, focusing on MRD strategy with 4 pillars: clinical evidence, reimbursement, biopharma partnerships, and Tempus collaboration.
- **NeXT Personal Launch**: Early access program with Tempus, 250+ patients monitored, 150+ doctors on waitlist. Medicare coverage submissions planned for breast, lung, and IO therapy monitoring in 2024.
- **Biopharma Growth**: Moderna's Phase III trial ramping up, Myriad expanding ImmunoID NeXT use, and ClearNote partnership for epigenomic solutions.

**【CFO Financial Commentary】**
- **Q4 2023 Results**: Revenue $19.7 million (18% YoY), gross margin 26.5% (12.7pt improvement). Full-year net loss $108.3 million, cash balance $114.2 million.
- **2024 Guidance**: Revenue $73-75 million, oncology segment $65-67 million (biopharma +15%, offsetting 25% decline from Natera). Gross margin ~25%, net loss $80 million.
- **Cost Management**: $35 million expense reduction, focusing on variable costs for scalability.

**【Q&A Highlights】**
- **Biopharma Momentum**: Tempus partnership driving MRD adoption, Moderna trial enrollment progressing. Tempus salesforce to co-commercialize NeXT Personal with minimal cash investment.
- **Reimbursement Strategy**: Focused on 3 high-impact cancer types, leveraging clinical evidence from TRACERx, Royal Marsden, and VHIO collaborations.
- **2025 Outlook**: $100 million target achievable via MRD growth, biopharma expansion, and VA program stability. Gross margin to low 30s as scale benefits materialize.

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