| Original | Translation |
|---|---|
| Guardant Health, Inc. | κ°λνΈ ν¬μ€(Guardant Health, Inc.) |
| (GH) Q4 2025 Earnings Call February 19, 2026 4:30 PM EST Company Participants Zarak Khurshid - Vice President of Investor Relations Helmy Eltoukhy - Co-Founder, Co-CEO & Chairman AmirAli Talasaz - Co-CEO & Director Michael Bell - Chief Financial Officer Conference Call Participants Daniel Leonard - UBS Investment Bank, Research Division Puneet Souda - Leerink Partners LLC, Research Division Douglas Schenkel - Wolfe Research, LLC Tycho Peterson - Jefferies LLC, Research Division Daniel Markowitz - Evercore ISI Institutional Equities, Research Division Andrew Brackmann - William Blair & Company L.L.C., Research Division Subhalaxmi Nambi - Guggenheim Securities, LLC, Research Division Mark Massaro - BTIG, LLC, Research Division Kyle Mikson - Canaccord Genuity Corp., Research Division Casey Woodring - JPMorgan Chase & Co, Research Division Paul Stewardson - Stifel, Nicolaus & Company, Incorporated, Research Division Luke Sergott - Barclays Bank PLC, Research Division Jack Meehan - Nephron Research LLC William Bonello - Craig-Hallum Capital Group LLC, Research Division Presentation Operator Thank you for attending the Guardant Health Q4 2025 Earnings Call. | **κ°λνΈ ν¬μ€ (GH) 2025λ
4λΆκΈ° μ€μ λ°ν 컨νΌλ°μ€ μ½** 2026λ 2μ 19μΌ λλΆ νμ€μ μ€ν 4μ 30λΆ **νμ¬ μ°Έμμ** μλ½ μΏ λ₯΄μλ - ν¬μμ κ΄κ³ λ΄λΉ λΆμ¬μ₯ ν¬λ―Έ μν¬ν€ - 곡λ 창립μ, 곡λ μ΅κ³ κ²½μμ(CEO) κ²Έ μ΄μ¬ν μμ₯ μλ―Έλ₯΄μ리 νλΌμ¬μ¦ - 곡λ μ΅κ³ κ²½μμ(CEO) κ²Έ μ΄μ¬ λ§μ΄ν΄ 벨 - μ΅κ³ μ¬λ¬΄μ± μμ(CFO) **컨νΌλ°μ€ μ½ μ°Έμμ** λ€λμ λ λλ - UBS ν¬μμν 리μμΉ λΆλ¬Έ νΈλ μλ€ - 리λ§ν¬ ννΈλμ€ LLC 리μμΉ λΆλ¬Έ λκΈλ¬μ€ μ₯ν΄ - μΈν 리μμΉ LLC νμ΄μ½ νΌν°μ¨ - μ νλ¦¬μ€ LLC 리μμΉ λΆλ¬Έ λ€λμ λ§μ½μμΈ - μλ²μ½μ΄ ISI μΈμ€ν°νμ λ μμΏΌν°μ€ 리μμΉ λΆλ¬Έ μ€λλ₯ λΈλλ§ - μ리μ λΈλ μ΄ & μ»΄νΌλ LLC 리μμΉ λΆλ¬Έ μλ°λ½μ€λ―Έ λ¨λΉ - ꡬκ²νμ μ¦κΆ LLC 리μμΉ λΆλ¬Έ λ§ν¬ λ§μ¬λ‘ - BTIG, LLC 리μμΉ λΆλ¬Έ μΉ΄μΌ λ―Ήμ¨ - μΊλμ½λ μ λ΄μ΄ν° λ²μΈ 리μμΉ λΆλ¬Έ μΌμ΄μ μ°λλ§ - JPλͺ¨κ±΄ 체μ΄μ€ & μ»΄νΌλ 리μμΉ λΆλ¬Έ ν΄ μ€νμ΄λμ¨ - μ€ν°ν , λμ½λΌμ°μ€ & μ»΄νΌλ 리μμΉ λΆλ¬Έ λ£¨ν¬ μκ³³ - λ°ν΄λ μ΄μ¦ μν PLC 리μμΉ λΆλ¬Έ μ λ―Έν - λ€νλ‘ λ¦¬μμΉ LLC μ리μ 보λ¬λ‘ - ν¬λ μ΄κ·Έ-ν λΌ μΊνΌν κ·Έλ£Ή LLC 리μμΉ λΆλ¬Έ **λ°ν** **μ¬νμ** κ°λνΈ ν¬μ€μ 2025λ 4λΆκΈ° μ€μ λ°ν 컨νΌλ°μ€ μ½μ μ°Έμν΄ μ£Όμ μ κ°μ¬ν©λλ€. |
| My name is Cameron, and I'll be your moderator for today. [Operator Instructions] I would now like to pass the conference over to your host, Zarak Khurshid, VP of Investor Relations. You may proceed. Zarak Khurshid Vice President of Investor Relations Thank you. Earlier today, Guardant Health released financial results for the quarter and year ended December 31, 2025. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO; AmirAli Talasaz, Co-CEO; and Mike Bell, Chief Financial Officer. Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal securities laws. | μ μ΄λ¦μ Cameronμ΄λ©°, μ€λ μ¬νλ₯Ό λ§‘μμ΅λλ€. [μ΄μμ μλ΄] μ΄μ ν¬μμ κ΄κ³ λ΄λΉ λΆμ¬μ₯ Zarak Khurshidλκ» λ§μ΄ν¬λ₯Ό λκΈ°κ² μ΅λλ€. λ§μν΄μ£Όμμμ€. **Zarak Khurshid** **ν¬μμ κ΄κ³ λ΄λΉ λΆμ¬μ₯** κ°μ¬ν©λλ€. μ€λ μΌμ° Guardant Healthλ 2025λ 12μ 31μΌ λ§κ° λΆκΈ° λ° μ°κ° μ¬λ¬΄ μ€μ μ λ°ννμ΅λλ€. μ€λ Guardantμμ μ μ ν¨κ» ν΄μ£Όμ λΆλ€μ 곡λ CEO Helmy Eltoukhyλ, 곡λ CEO AmirAli Talasazλ, κ·Έλ¦¬κ³ μ΅κ³ μ¬λ¬΄ μ± μμ Mike Bellλμ λλ€. μμνκΈ° μ μ, λ³Έ 컨νΌλ°μ€ μ½μμ κ²½μμ§μ μ°λ°© μ¦κΆλ²μ μκ±°ν λ―Έλ μμΈ‘ μ§μ μ ν κ²μμ μκΈ°μμΌ λλ¦¬κ³ μ ν©λλ€. |
| These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties as well as the non-GAAP financial reconciliation to most directly comparable GAAP financial measures are available in the press release Guardant issued today as well as in our 10-K and other filings with the SEC. | λ³Έ μ§μ λ€μ μ€μ κ²°κ³Όλ μ¬κ±΄μ΄ μμμΉμ μ€μ§μ μΌλ‘ λ€λ₯΄κ² λνλ μ μλ μ€λν μνκ³Ό λΆνμ€μ±μ λ΄ν¬νκ³ μμ΅λλ€. λ³Έ 컨νΌλ°μ€ μ½μμλ νΉμ λͺ μλ νλͺ©λ€μ μ μΈνλλ‘ μ‘°μ λ λΉGAAP μ¬λ¬΄ μΈ‘μ μΉμ λν μ€λͺ λ λ€λ£° μμ μ λλ€. μ€λν μνκ³Ό λΆνμ€μ±μ λν μΆκ° μ 보μ κ°μ₯ μ§μ μ μΌλ‘ λΉκ΅ κ°λ₯ν GAAP μ¬λ¬΄ μΈ‘μ μΉμ λΉGAAP μ¬λ¬΄ μΈ‘μ μΉ κ°μ μ‘°μ λ΄μμ Guardantκ° μ€λ λ°νν 보λμλ£, κ·Έλ¦¬κ³ λΉμ¬μ 10-K λ³΄κ³ μ λ° SEC μ μΆ κΈ°ν μλ₯μμ νμΈνμ€ μ μμ΅λλ€. |
| Guardant disclaims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, future events or otherwise, except as required by law. The information in this conference call is accurate only as of the live broadcast. With that, I would like to turn the call over to Helmy. Helmy Eltoukhy Co-Founder, Co-CEO & Chairman Thanks, Zarak. Good afternoon, and thank you for joining our fourth quarter and full year 2025 earnings call. Starting on Slide 3. 2025 was a breakout year for Guardant, where years of investment continues to fuel breakthrough innovation and best-in-class execution across our portfolio. | Guardantλ λ²λ₯ μμ μꡬνλ κ²½μ°λ₯Ό μ μΈνκ³ , μλ‘μ΄ μ 보, λ―Έλ μ¬κ±΄ λλ κΈ°ν μ¬μ λ‘ μΈν΄ μ¬λ¬΄ μ λ§ λ° λ―Έλ μμΈ‘ μ§μ μ μ
λ°μ΄νΈνκ±°λ μμ ν μ΄λ ν μλλ μ무λ μμμ λ°νλλ€. λ³Έ 컨νΌλ°μ€ μ½μ μ 보λ μ€μκ° λ°©μ‘ μμ μλ§ μ νν©λλ€. μ΄μ΄μ, ν¬λ―Έμκ² λ§μ΄ν¬λ₯Ό λκΈ°κ² μ΅λλ€. **ν¬λ―Έ μν¬ν€ (곡λ 창립μ, 곡λ CEO κ²Έ νμ₯)** μλ½λ, κ°μ¬ν©λλ€. μλ νμλκΉ, κ·Έλ¦¬κ³ 2025λ 4λΆκΈ° λ° μ°κ° μ€μ λ°ν 컨νΌλ°μ€ μ½μ μ°Έμ¬ν΄μ£Όμ μ κ°μ¬ν©λλ€. μ¬λΌμ΄λ 3λΆν° μμνκ² μ΅λλ€. 2025λ μ κ°λνΈμκ² νκΈ°μ μΈ ν ν΄μμ΅λλ€. μλ κ°μ ν¬μκ° λΉμ¬ ν¬νΈν΄λ¦¬μ€ μ λ°μ κ±Έμ³ νκΈ°μ μΈ νμ κ³Ό λκΈ μ΅κ³ μ μ€νλ ₯μ κ³μν΄μ λ·λ°μΉ¨νμ΅λλ€. |
| In oncology, we introduced groundbreaking applications for Guardant360 Liquid, upgraded Guardant360 tissue onto our smart platform and expanded Reveal to support therapy monitoring. In screening, we expanded Shield to include a multi-cancer detection results report. At the same time, we made significant progress driving adoption across the portfolio. We have seen exceptional growth in our oncology business, primarily due to the new capabilities and insights enabled by our smart apps that are increasing both the breadth and depth of ordering of Guardant360 more than a decade after its launch. | μ λΆμΌμμλ Guardant360 Liquidμ© νκΈ°μ μΈ μ ν리μΌμ΄μ
μ λμ
νκ³ , Guardant360 tissueλ₯Ό μ ν¬ μ€λ§νΈ νλ«νΌμΌλ‘ μ
κ·Έλ μ΄λνμΌλ©°, Revealμ μΉλ£ λͺ¨λν°λ§ μ§μμ μν΄ νμ₯νμ΅λλ€. μ λ³κ²μ¬ λΆμΌμμλ Shieldλ₯Ό λ€μ€ μ κ²μΆ κ²°κ³Ό λ³΄κ³ μλ₯Ό ν¬ν¨νλλ‘ νμ₯νμ΅λλ€. λμμ, μ ν¬λ μ 체 ν¬νΈν΄λ¦¬μ€μ κ±Έμ³ μ±νμ μ΄μ§νλ λ° μλΉν μ§μ μ μ΄λ£¨μμ΅λλ€. μ ν¬ μ μ¬μ λΆλ¬Έμ νμν μ±μ₯μ κΈ°λ‘νμ΅λλ€. μ΄λ μ£Όλ‘ Guardant360 μΆμ 10λ μ΄ λμμμλ λΆκ΅¬νκ³ , μ ν¬ μ€λ§νΈ μ±μ΄ μ 곡νλ μλ‘μ΄ κΈ°λ₯κ³Ό ν΅μ°°λ ₯μ΄ Guardant360μ μ£Όλ¬Έ νκ³Ό κΉμ΄λ₯Ό λͺ¨λ μ¦κ°μν€κ³ μλ λλΆμ λλ€. |
| In MRD, we received Medicare coverage for CRC surveillance in early 2025 and growing clinical data generation for Reveal positions us well for additional reimbursement coverage this year. And 2025 represents the first full year for Shield IVD where very meaningful volume and revenue generation exceeds our expectations. We have significantly expanded the commercial team and established impactful strategic partnerships to meet the growing demand for a high-performing blood-based screening option. These advancements reflect our growing execution at scale as we deliver actionable insights to physicians and patients across the care continuum. | MRD λΆλ¬Έμμ, 2025λ μ΄ λμ₯μ(CRC) κ°μλ₯Ό μν λ©λμΌμ΄ 보μ₯μ νλνμΌλ©°, Revealμ λν μμ λ°μ΄ν° μμ±μ΄ νλλλ©΄μ μ¬ν΄ μΆκ°μ μΈ λ³΄ν κΈμ¬ μ μ©μ μν μ 리ν μ μ§λ₯Ό λ€μ§κ³ μμ΅λλ€. κ·Έλ¦¬κ³ 2025λ μ Shield IVDμ 첫 μμ ν ν ν΄κ° λ κ²μ΄λ©°, μ΄ κΈ°κ° λμ λ§€μ° μλ―Έ μλ λ¬Όλκ³Ό λ§€μΆ μ°½μΆμ΄ μ°λ¦¬μ κΈ°λμΉλ₯Ό μνν κ²μΌλ‘ μμλ©λλ€. μ ν¬λ κ³ μ±λ₯ νμ‘ κΈ°λ° μ€ν¬λ¦¬λ μ΅μ μ λν μ¦κ°νλ μμλ₯Ό μΆ©μ‘±μν€κΈ° μν΄ μμ νμ λν νμ₯νκ³ μν₯λ ₯ μλ μ λ΅μ ννΈλμμ ꡬμΆνμ΅λλ€. μ΄λ¬ν μ§μ μ μ ν¬κ° μ 체 μ§λ£ κ³Όμ μ κ±Έμ³ μμ¬μ νμμκ² μ€ν κ°λ₯ν ν΅μ°°λ ₯μ μ 곡νλ©΄μ, κ·λͺ¨μ λ°λ₯Έ μ€νλ ₯μ΄ μ±μ₯νκ³ μμμ 보μ¬μ€λλ€. |
| Importantly, this execution has directly driven strong financial performance, both accelerating our top line growth and strengthening our path to profitability. Now I'd like to share a story that illustrates the real-world impact of our tests. A 60-year-old man had gone his entire life without being screened for colorectal cancer despite repeated recommendations from his physician each year to undergo a colonoscopy. Although he agreed to stool-based testing on several occasions, the kits were never completed once they arrived at his home. During a routine office visit, the patient was offered a Shield blood test, which he agreed to and the test was completed that same day in the office. | 무μ보λ€λ, μ΄λ¬ν μ€νμ λ§€μΆ μ±μ₯μ κ°μννκ³ μμ΅μ± ν보μ κΈΈμ ꡳ건ν ν¨μΌλ‘μ¨ κ²¬μ‘°ν μ¬λ¬΄ μ±κ³Όλ₯Ό μ§μ μ μΌλ‘ μ΄λμμ΅λλ€. μ΄μ μ ν¬ κ²μ¬κ° μ€μ μ μΌλ‘ λ―ΈμΉλ μν₯μ 보μ¬μ£Όλ μ΄μΌκΈ°λ₯Ό νλ λ§μλλ¦¬κ³ μ ν©λλ€. 60μΈ λ¨μ± ν λΆμ΄ λ§€λ μ£ΌμΉμλ‘λΆν° λμ₯ λ΄μκ²½ κ²μ¬λ₯Ό λ°μΌλΌλ λ°λ³΅μ μΈ κΆκ³ μλ λΆκ΅¬νκ³ νμ λμ₯μ κ²μ¬λ₯Ό λ°μ§ μμμ΅λλ€. κ·Έλ μ¬λ¬ μ°¨λ‘ λλ³ κ²μ¬μ λμνμ§λ§, κ²μ¬ ν€νΈκ° μ§μ λμ°©ν νμλ ν λ²λ μλ£λμ§ μμμ΅λλ€. μ κΈ° μ§λ£ λ°©λ¬Έ μ€, νμμκ² Shield νμ‘ κ²μ¬κ° μ μλμκ³ , κ·Έλ μ΄μ λμνμ¬ κ²μ¬λ κ°μ λ μ§λ£μ€μμ μλ£λμμ΅λλ€. |
| The Shield result was positive, which motivated the patient to undergo his very first colonoscopy following his physician's recommendation. The colonoscopy identified Stage 1 colon cancer and the patient was quickly scheduled for surgery. Because the cancer was caught early, he has been informed that his treatment is likely curative. The patient expressed deep gratitude for the accessibility and ease of use of the Shield blood-based test, which removed a long-standing barrier to screening and ultimately delivered a life-changing result. Turning to top line performance on Slide 4. | Shield κ²μ¬ κ²°κ³Όκ° μμ±μΌλ‘ λμ€μ, νμλ μ£ΌμΉμμ κΆκ³ μ λ°λΌ μμ 첫 λμ₯λ΄μκ²½μ λ°κ² λμμ΅λλ€. λμ₯λ΄μκ²½ κ²μ¬μμ 1κΈ° λμ₯μμ΄ νμΈλμκ³ , νμλ μ¦μ μμ μΌμ μ΄ μ‘νμ΅λλ€. μμ΄ μ‘°κΈ°μ λ°κ²¬λμκΈ° λλ¬Έμ, νμλ μΉλ£λ₯Ό ν΅ν΄ μμΉλ κ°λ₯μ±μ΄ λλ€λ μλ΄λ₯Ό λ°μμ΅λλ€. νμλ Shield νμ‘ κΈ°λ° κ²μ¬μ μ κ·Όμ±κ³Ό μ¬μ© νΈμμ±μ κΉμ κ°μ¬λ₯Ό ννμ΅λλ€. μ΄ κ²μ¬λ μ€λ«λμ μ λ³κ²μ¬μ μ₯λ²½μ΄μλ κ²μ μ κ±°νμ¬ κΆκ·Ήμ μΌλ‘ μΆμ λ³νμν€λ κ²°κ³Όλ₯Ό κ°μ ΈμκΈ° λλ¬Έμ λλ€. μ΄μ 4νμ΄μ§ μ¬λΌμ΄λμ λ§€μΆ μ€μ μ μ΄ν΄λ³΄κ² μ΅λλ€. |
| We delivered $281 million of revenue in the fourth quarter, representing 39% year-over-year growth and $982 million of revenue or 33% year-over-year growth for the full year. This exceptional performance reflects continued broad-based growth across our oncology screening and biopharma and data businesses. Taking a closer look at our oncology business on Slide 5. Oncology revenue increased 30% to $190 million and oncology volumes grew 38% to approximately 79,000 tests in the fourth quarter. Turning to Slide 6. Our Smart Platform is driving a clear step change in oncology volumes. | λ€, ν΄λΉ μ€μ λ°ν μ€ν¬λ¦½νΈλ₯Ό νκ΅μ΄λ‘ λ²μν΄ λλ¦¬κ² μ΅λλ€. --- μ ν¬λ 4λΆκΈ°μ 2μ΅ 8,100λ§ λ¬λ¬μ λ§€μΆμ κΈ°λ‘νλ©° μ λ λλΉ 39% μ±μ₯νμΌλ©°, μ°κ°μΌλ‘λ 9μ΅ 8,200λ§ λ¬λ¬μ λ§€μΆμ λ¬μ±νμ¬ μ λ λλΉ 33% μ±μ₯νμ΅λλ€. μ΄λ¬ν νμν μ€μ μ λΉμ¬μ μ’ μν μ€ν¬λ¦¬λ, λ°μ΄μ€μ μ½ λ° λ°μ΄ν° μ¬μ μ λ°μ κ±Έμ³ μ§μμ μΈ κ΄λ²μν μ±μ₯μ΄ μ΄λ£¨μ΄μ‘μμ λ°μν©λλ€. μ¬λΌμ΄λ 5μμ λΉμ¬μ μ’ μν μ¬μ μ μμΈν μ΄ν΄λ³΄κ² μ΅λλ€. 4λΆκΈ° μ’ μν λ§€μΆμ 30% μ¦κ°νμ¬ 1μ΅ 9,000λ§ λ¬λ¬λ₯Ό κΈ°λ‘νμΌλ©°, μ’ μν κ²μ¬λμ μ½ 79,000건μΌλ‘ 38% μ±μ₯νμ΅λλ€. μ¬λΌμ΄λ 6μΌλ‘ λμ΄κ°κ² μ΅λλ€. λΉμ¬μ μ€λ§νΈ νλ«νΌμ μ’ μν κ²μ¬λμμ νκΈ°μ μΈ λ³νλ₯Ό 견μΈνκ³ μμ΅λλ€. |
| Guardant360 continues to benefit from a consistent rollout of new Smart Platform applications which drive deeper clinical adoption. Guardant360 tissue gained traction following the major product upgrade release in the second quarter of 2025 and Reveal volumes have benefited from Medicare reimbursement for CRC surveillance in the first quarter of 2025. Together, these drivers will continue to catalyze very strong growth in our oncology business. Moving on to Slide 7. | Guardant360μ μμ νμ₯ μ±νμ μ¬νμν€λ μλ‘μ΄ Smart Platform μ ν리μΌμ΄μ μ κΎΈμ€ν μΆμλ‘ μΈν΄ μ§μμ μΌλ‘ ννμ λ°κ³ μμ΅λλ€. Guardant360 μ‘°μ§ κ²μ¬λ 2025λ 2λΆκΈ° μ£Όμ μ ν μ κ·Έλ μ΄λ μΆμ μ΄ν νλ ₯μ λ°μμΌλ©°, Revealμ κ²μ¬λμ 2025λ 1λΆκΈ° CRC(λμ₯μ) κ°μμ λν λ©λμΌμ΄ μνμΌλ‘ μΈν΄ ννμ λ°μμ΅λλ€. μ΄λ¬ν λλ ₯λ€μ΄ ν¨κ» λΉμ¬μ μ’ μν μ¬μ λΆλ¬Έμμ λ§€μ° κ°λ ₯ν μ±μ₯μ κ³μν΄μ μ΄μ§ν κ²μ λλ€. μ¬λΌμ΄λ 7λ‘ λμ΄κ°κ² μ΅λλ€. |
| With each patient tested, our data repository continues to deepen and diversify, bringing together rapidly growing smart epigenetic profiles, multimodal longitudinal data sets and an expanding set of earlier-stage and asymptomatic [Audio Gap] Infinity AI learning engine to this expanding data treasury, we can accelerate therapeutic discovery and biomarker development for our biopharma partners while uncovering new biological insights that reinforce our clinical franchise. The result is a compounding flywheel that steadily increases the clinical utility of our portfolio and expands the impact of what we can deliver to physicians and their patients. | νμ κ²μ¬κ° μ§νλ μλ‘ λΉμ¬μ λ°μ΄ν° 리ν¬μ§ν 리λ λμ± μ¬νλκ³ λ€μν΄μ§κ³ μμΌλ©°, κΈμ¦νλ μ€λ§νΈ νμ±μ μ ν νλ‘νμΌ, λ€μ€ λͺ¨λ μ’ λ¨ λ°μ΄ν° μΈνΈ, κ·Έλ¦¬κ³ μ΄κΈ° λ¨κ³ λ° λ¬΄μ¦μ [μμ± μ μ€] νμκ΅°μ λν λ°©λν λ°μ΄ν°λ₯Ό ν΅ν©νκ³ μμ΅λλ€. μ΄μ²λΌ λ°©λν΄μ§λ λ°μ΄ν° μμ°μ Infinity AI νμ΅ μμ§μ μ μ©ν¨μΌλ‘μ¨, λΉμ¬λ λ°μ΄μ€ μ μ½ ννΈλλ₯Ό μν μΉλ£μ λ°κ΅΄ λ° λ°μ΄μ€λ§μ»€ κ°λ°μ κ°μννλ λμμ, λΉμ¬μ μμ νλμ°¨μ΄μ¦λ₯Ό κ°ννλ μλ‘μ΄ μλ¬Όνμ ν΅μ°°λ ₯μ λ°κ²¬ν μ μμ΅λλ€. κ·Έ κ²°κ³Όλ λΉμ¬ ν¬νΈν΄λ¦¬μ€μ μμμ μ μ©μ±μ κΎΈμ€ν λμ΄κ³ , μμ¬μ νμμκ² μ 곡ν μ μλ μν₯λ ₯μ νλνλ 볡리 ν¨κ³Όμ νλΌμ΄ν (compounding flywheel)μ λλ€. |
| We have already applied Infinity AI to develop 15 smart applications on Guardant360 liquid, and we believe these applications meaningfully expand the clinical utility of Guardant360 liquid while further extending our leadership in the liquid CGP market. Looking more closely at some of the recent highlights within our oncology business on Slide 8. All of our oncology products contributed meaningfully to our fourth quarter 38% year-over-year growth in volumes with Guardant360 delivering remarkable volume growth of nearly 30% year-over-year. Reveal continues to be our fastest-growing product, reflecting growing demand for tissue-free MRD. | μ ν¬λ μ΄λ―Έ Infinity AIλ₯Ό Guardant360 liquidμ μ μ©νμ¬ 15κ°μ μ€λ§νΈ μ ν리μΌμ΄μ μ κ°λ°νμΌλ©°, μ΄ μ ν리μΌμ΄μ λ€μ΄ Guardant360 liquidμ μμμ μ μ©μ±μ μλ―Έ μκ² νμ₯νκ³ μ‘체 CGP μμ₯μμ μ ν¬μ 리λμμ λμ± κ³΅κ³ ν ν κ²μ΄λΌκ³ λ―Ώμ΅λλ€. μ¬λΌμ΄λ 8μμ μ ν¬ μ’ μν μ¬μ λΆλ¬Έμ μ΅κ·Ό μ£Όμ μ±κ³Όλ€μ μ’ λ μμΈν μ΄ν΄λ³΄κ² μ΅λλ€. μ ν¬μ λͺ¨λ μ’ μν μ νλ€μ 4λΆκΈ° μ λ λλΉ 38%μ λ¬Όλ μ±μ₯μ μλ―Έ μκ² κΈ°μ¬νμΌλ©°, νΉν Guardant360μ μ λ λλΉ κ±°μ 30%μ λ¬νλ λλΌμ΄ λ¬Όλ μ±μ₯μ κΈ°λ‘νμ΅λλ€. Revealμ μ‘°μ§ κ²μ¬ μλ MRD(λ―ΈμΈμμ‘΄μ§ν)μ λν μμ μ¦κ°λ₯Ό λ°μνλ©°, μ ν¬μ κ°μ₯ λΉ λ₯΄κ² μ±μ₯νλ μ νμΌλ‘ μ리맀κΉνκ³ μμ΅λλ€. |
| We are particularly encouraged by the early uptake of Reveal for late-stage therapy response monitoring launched in the fourth quarter, which is broadening its clinical use. We are advancing the clinical evidence supporting Reveal and recently submitted our chemo monitoring data package to MolDx for Medicare reimbursement and data from our CDK4/6 monitoring study for publication. We continued expanding global access in Q4 with the launch of our Guardant360 CDx technology with Policlinico Gamelli, a leading oncology center in Rome, Italy. | 4λΆκΈ°μ μΆμλ νκΈ° μΉλ£ λ°μ λͺ¨λν°λ§μ© 리λΉ(Reveal)μ μ΄κΈ° μ±νμ΄ μμμ νμ© λ²μλ₯Ό λνκ³ μλ€λ μ μ νΉν κ³ λ¬΄μ μ λλ€. μ ν¬λ 리λΉ(Reveal)μ λ·λ°μΉ¨νλ μμμ κ·Όκ±°λ₯Ό κ°ννκ³ μμΌλ©°, μ΅κ·Ό λ©λμΌμ΄ μνμ μν΄ MolDxμ ννμλ² λͺ¨λν°λ§ λ°μ΄ν° ν¨ν€μ§λ₯Ό μ μΆνμ΅λλ€. λν, CDK4/6 λͺ¨λν°λ§ μ°κ΅¬ λ°μ΄ν°λ μΆνμ μν΄ μ μΆνμ΅λλ€. μ ν¬λ 4λΆκΈ°μ μ΄ν리μ λ‘λ§μ μ λμ μΈ μ’ μν μΌν°μΈ ν΄λ¦¬ν΄λ¦¬λμ½ κ°λ©λ¦¬(Policlinico Gamelli)μ ν¨κ» Guardant360 CDx κΈ°μ μ μΆμνλ©° κΈλ‘λ² μ κ·Όμ±μ μ§μμ μΌλ‘ νλνμ΅λλ€. |
| With approximately 400,000 new malignant tumor cases diagnosed annually across Italy, we are excited to empower oncologists to make more informed treatment decisions for patients with solid tumor cancers. Turning to Slide 9 to take a closer look at our Reveal data pipeline. We continue to make strong progress in generating and publishing compelling data across multiple cancer types. Based on the Medicare coverage we gained for CRC surveillance, we have now submitted additional data packages to support coverage in breast cancer surveillance, immuno-oncology monitoring and chemo monitoring. | μ΄ν리μ μ μμμ λ§€λ
μ½ 40λ§ λͺ
μ μ κ· μ
μ± μ’
μ νμκ° μ§λ¨λκ³ μμΌλ©°, μ ν¬λ μ’
μ μ λ¬Έμλ€μ΄ κ³ νμ νμλ€μ μν΄ λ μ 보μ κΈ°λ°ν μΉλ£ κ²°μ μ λ΄λ¦΄ μ μλλ‘ νμ μ€μ΄μ£Όκ² λμ΄ κΈ°μ©λλ€. μ¬λΌμ΄λ 9λ²μΌλ‘ λμ΄κ°μ μ ν¬ Reveal λ°μ΄ν° νμ΄νλΌμΈμ λ μμΈν μ΄ν΄λ³΄κ² μ΅λλ€. μ ν¬λ λ€μν μ μ νμ κ±Έμ³ μ€λλ ₯ μλ λ°μ΄ν° μμ± λ° λ°νμ μμ΄ κ³μν΄μ ν° μ§μ μ μ΄λ£¨κ³ μμ΅λλ€. μ ν¬κ° CRC(λμ₯μ) κ°μλ₯Ό μν΄ νλν λ©λμΌμ΄ 보μ₯μ λ°νμΌλ‘, νμ¬ μ λ°©μ κ°μ, λ©΄μνμ λͺ¨λν°λ§ λ° ννμλ² λͺ¨λν°λ§μ λν 보μ₯μ μ§μνκΈ° μν΄ μΆκ° λ°μ΄ν° ν¨ν€μ§λ₯Ό μ μΆνμ΅λλ€. |
| As I just mentioned, we also plan to submit the package for CDK4/6 inhibitor monitoring following the publication. We were encouraged to see data from the largest study of MRD in Stage II colon cancer published in the Journal of Clinical Oncology, which shows that detecting ctDNA with Reveal better predicts recurrence and overall survival than standard imaging. Looking ahead, we have ongoing studies across more than 5 additional tumor types in both the adjuvant and surveillance settings. Together, the growing body of evidence will continue to strengthen the clinical utility of Reveal and support broader adoption in MRD. Moving on to Slide 10. | λ°©κΈ λ§μλλ Έλ―μ΄, μ ν¬λ μΆν μ΄ν CDK4/6 μ΅μ μ λͺ¨λν°λ§μ μν ν¨ν€μ§λ₯Ό μ μΆν κ³νμ λλ€. μ ν¬λ Journal of Clinical Oncologyμ κ²μ¬λ 2κΈ° λμ₯μ MRDμ λν μ΅λ κ·λͺ¨ μ°κ΅¬ λ°μ΄ν°λ₯Ό λ³΄κ³ κ³ λ¬΄λμμ΅λλ€. μ΄ μ°κ΅¬λ Revealμ ν΅ν΄ ctDNAλ₯Ό κ²μΆνλ κ²μ΄ νμ€ μμ μ§λ¨λ³΄λ€ μ¬λ° λ° μ 체 μμ‘΄μ¨μ λ μ μμΈ‘νλ€λ κ²μ 보μ¬μ€λλ€. μμΌλ‘ μ ν¬λ 보쑰 μλ² λ° κ°μ μ€μ λͺ¨λμμ 5κ° μ΄μμ μΆκ° μμ’ μ κ±Έμ³ μ°κ΅¬λ₯Ό μ§ννκ³ μμ΅λλ€. μ’ ν©μ μΌλ‘, μΆμ λλ μ¦κ±°λ€μ Revealμ μμμ μ μ©μ±μ κ³μν΄μ κ°ννκ³ , MRD λΆμΌμμ λ κ΄λ²μν μ±νμ μ§μν κ²μ λλ€. μ¬λΌμ΄λ 10μΌλ‘ λμ΄κ°κ² μ΅λλ€. |
| Building on our leadership in tissue-free MRD, we launched Guardant Reveal for therapy monitoring in the fourth quarter, expanding the franchise into a significant new opportunity in late-stage cancer. Physicians can now use a simple blood test to gain a real-time molecular view of treatment response and detect disease progression earlier. While still early in the launch, we have been very encouraged by the initial traction we are seeing. We believe we are building a meaningful competitive moat in our oncology business through the combined strength of Guardant360 and Reveal. | μ‘°μ§ λΉμΉ¨μ΅ MRD(λ―ΈμΈμμ‘΄μ§ν) λΆμΌμμμ μ λμ μΈ μ§μλ₯Ό λ°νμΌλ‘, μ ν¬λ 4λΆκΈ°μ μΉλ£ λͺ¨λν°λ§μ μν κ°λνΈ λ¦¬λΉ(Guardant Reveal)μ μΆμνμ΅λλ€. μ΄λ μ§νμ± μ λΆμΌμμ μ€μν μλ‘μ΄ κΈ°νλ‘ μ ν¬ μ¬μ μμμ νμ₯νλ κ³κΈ°κ° λμμ΅λλ€. μ΄μ μμ¬λ€μ κ°λ¨ν νμ‘ κ²μ¬λ₯Ό ν΅ν΄ μΉλ£ λ°μμ μ€μκ°μΌλ‘ λΆμ μμ€μμ νμ νκ³ , μ§λ³ μ§νμ λ μ‘°κΈ°μ κ°μ§ν μ μκ² λμμ΅λλ€. μμ§ μΆμ μ΄κΈ° λ¨κ³μμλ λΆκ΅¬νκ³ , μ ν¬λ νμ¬ λνλκ³ μλ μ΄κΈ° μμ₯ λ°μμ λ§€μ° κ³ λ¬΄λμ΄ μμ΅λλ€. μ ν¬λ κ°λνΈ360(Guardant360)κ³Ό 리λΉ(Reveal)μ κ²°ν©λ κ°μ μ ν΅ν΄ μ ν¬ μ’ μν μ¬μ μμ μλ―Έ μλ κ²½μ ν΄μ(competitive moat)λ₯Ό ꡬμΆνκ³ μλ€κ³ λ―Ώμ΅λλ€. |
| Guardant is uniquely positioned with scaled offerings spanning both treatment selection and monitoring, enabling a more comprehensive view of the patient journey. This differentiation is driving deeper clinical adoption, supporting more integrated ordering patterns and creating a natural synergistic dynamic across the oncology franchise. When used together, Guardant360 and Reveal enable a seamless approach to therapy selection, monitoring and retreatment across the continuum of care. We are also excited about the potential for therapy monitoring with Guardant360, highlighted by the results from the AstraZeneca-sponsored SERENA-6 trial. | κ°λνΈλ μΉλ£ μ νκ³Ό λͺ¨λν°λ§μ λͺ¨λ μμ°λ₯΄λ νμ₯λ μ ν ν¬νΈν΄λ¦¬μ€λ₯Ό ν΅ν΄ νμ μΉλ£ μ¬μ μ λ³΄λ€ ν¬κ΄μ μΌλ‘ νμ ν μ μλλ‘ νλ λ 보μ μΈ μ μ§λ₯Ό ꡬμΆνκ³ μμ΅λλ€. μ΄λ¬ν μ°¨λ³νλ μμ μ±νμ λμ± μ¬νμν€κ³ , λ³΄λ€ ν΅ν©μ μΈ μ£Όλ¬Έ ν¨ν΄μ λ·λ°μΉ¨νλ©°, μ’ μν μ¬μ λΆλ¬Έ μ λ°μ κ±Έμ³ μμ°μ€λ¬μ΄ μλμ§ ν¨κ³Όλ₯Ό μ°½μΆνκ³ μμ΅λλ€. κ°λνΈ360κ³Ό 리λΉμ ν¨κ» μ¬μ©νλ©΄, μΉλ£μ μ κ³Όμ μ κ±Έμ³ μΉλ£ μ ν, λͺ¨λν°λ§, κ·Έλ¦¬κ³ μ¬μΉλ£μ λν μνν μ κ·Όμ κ°λ₯νκ² ν©λλ€. μ ν¬λ λν μμ€νΈλΌμ λ€μΉ΄κ° νμν SERENA-6 μμμν κ²°κ³Όλ‘ μ μ¦λ κ°λνΈ360μ νμ©ν μΉλ£ λͺ¨λν°λ§μ μ μ¬λ ₯μ λν΄μλ ν° κΈ°λλ₯Ό νκ³ μμ΅λλ€. |
| This study demonstrated a progression-free survival benefit when late-stage breast cancer patients were switched to camizestrant following the detection of ESR1 mutations in blood. Upon companion diagnostic approval of Guardant360, we believe this practice-changing protocol could represent a meaningful driver of test volume. Together, these advances reflect the growing role of blood-based monitoring in cancer care. Shifting gears to our biopharma and data business on Slide 11. We delivered another year of strong performance with revenue growing 18% year-over-year to $210 million in 2025. | μ΄λ² μ°κ΅¬λ νμ‘μμ ESR1 λ³μ΄κ° κ²μΆλ ν λ§κΈ° μ λ°©μ νμλ€μ΄ μΉ΄λ―Έμ μ€νΈλνΈλ‘ μ νλμμ λ 무μ§ν μμ‘΄(PFS) μ΄μ μ μ
μ¦νμ΅λλ€. Guardant360μ λλ°μ§λ¨ μΉμΈ μ, μ ν¬λ μ΄ μ§λ£ λ°©μμ λ³νμν¬ μ μλ νλ‘ν μ½μ΄ κ²μ¬λ μ¦λμ μ€μν λλ ₯μ΄ λ μ μλ€κ³ λ―Ώμ΅λλ€. μ’
ν©μ μΌλ‘ λ³Ό λ, μ΄λ¬ν μ§μ λ€μ μ μΉλ£μμ νμ‘ κΈ°λ° λͺ¨λν°λ§μ μν μ΄ μ»€μ§κ³ μμμ λ°μν©λλ€. μ¬λΌμ΄λ 11μ μλ μ ν¬ λ°μ΄μ€ μ μ½ λ° λ°μ΄ν° μ¬μ μΌλ‘ λμ΄κ°κ² μ΅λλ€. μ ν¬λ 2025λ μ λ§€μΆμ΄ μ λ λλΉ 18% μ±μ₯νμ¬ 2μ΅ 1μ²λ§ λ¬λ¬λ₯Ό κΈ°λ‘νλ©° λ ν ν΄ κ²¬μ‘°ν μ±κ³Όλ₯Ό λ¬μ±νμ΅λλ€. |
| We are a leader in companion diagnostics with 25 approvals to date across the U.S., Japan and Europe and a robust pipeline of ongoing CDx programs. In the last 6 months alone, we have announced 5 new CDx approvals for Guardant360, including the U.S. approval last month for the encorafenib combination therapy in patients with BRAF V600E mutant metastatic colorectal cancer, representing the first FDA approval for Guardant360 in CRC. Our biopharma partner base now includes more than 200 companies. And in January, we announced a multiyear agreement with Merck to develop companion diagnostics and commercialize novel therapies. | μ ν¬λ λ―Έκ΅, μΌλ³Έ, μ λ½ μ μμμ νμ¬κΉμ§ 25건μ μΉμΈμ νλνμΌλ©°, μ§ν μ€μΈ λλ° μ§λ¨(CDx) νλ‘κ·Έλ¨μ ννν νμ΄νλΌμΈμ 보μ ν λλ° μ§λ¨ λΆμΌμ μ λ κΈ°μ μ λλ€. μ§λ 6κ°μ λμμλ§ Guardant360μ λν 5건μ μλ‘μ΄ λλ° μ§λ¨ μΉμΈμ λ°ννμ΅λλ€. μ¬κΈ°μλ BRAF V600E λ³μ΄ μ μ΄μ± μ§κ²°μ₯μ νμλ₯Ό μν μμ½λΌνλ λ³μ© μλ²μ λν μ§λλ¬ λ―Έκ΅ μΉμΈμ΄ ν¬ν¨λλ©°, μ΄λ Guardant360μ΄ μ§κ²°μ₯μ(CRC) λΆμΌμμ FDA μΉμΈμ λ°μ 첫 μ¬λ‘μ λλ€. μ ν¬μ λ°μ΄μ€ μ μ½ ννΈλ κΈ°λ°μ νμ¬ 200κ° μ΄μμ κΈ°μ μ ν¬ν¨νκ³ μμ΅λλ€. κ·Έλ¦¬κ³ μ§λ 1μμλ Merckμ λλ° μ§λ¨μ κ°λ°νκ³ μλ‘μ΄ μΉλ£λ²μ μμ©ννκΈ° μν λ€λ κ°μ κ³μ½μ λ°ννμ΅λλ€. |
| This partnership reflects the growing role of our Smart Platform across both liquid and tissue and drug development and the strategic value of our platform to biopharma customers. We also made significant progress expanding both the scale and utility of our data set through a series of high-impact partnerships. These collaborations integrate comprehensive EMR records for genomic and epigenomic tumor profiling to accelerate cancer therapy research and development, advanced drug response prediction and biomarker insights using multimodal AI and enable biopharma partners to access EHR and clinical genomic data to support more efficient clinical development of new cancer therapies. | μ΄λ² ννΈλμμ μ‘체 μκ² λ° μ‘°μ§ μκ², μ μ½ κ°λ° μ λ°μ κ±Έμ³ λΉμ¬ Smart Platformμ μν μ΄ νλλκ³ μμΌλ©°, λ°μ΄μ€ μ μ½ κ³ κ°λ€μκ² λΉμ¬ νλ«νΌμ΄ μ§λ μ λ΅μ κ°μΉλ₯Ό λ°μν©λλ€. λν, μ ν¬λ μΌλ ¨μ νκΈλ ₯ μλ ννΈλμμ ν΅ν΄ λΉμ¬ λ°μ΄ν° μΈνΈμ κ·λͺ¨μ νμ©μ±μ λͺ¨λ νμ₯νλ λ° μλΉν μ§μ μ μ΄λ£¨μμ΅λλ€. μ΄λ¬ν νλ ₯μ μ μ 체 λ° νμ±μ μ 체 μ’ μ νλ‘νμΌλ§μ μν ν¬κ΄μ μΈ EMR κΈ°λ‘μ ν΅ν©νμ¬ μ μΉλ£ μ°κ΅¬ λ° κ°λ°μ κ°μννκ³ , λ€μ€ λͺ¨λ AIλ₯Ό νμ©νμ¬ ν₯μλ μ½λ¬Ό λ°μ μμΈ‘ λ° λ°μ΄μ€λ§μ»€ ν΅μ°°λ ₯μ μ 곡νλ©°, λ°μ΄μ€ μ μ½ ννΈλλ€μ΄ EHR λ° μμ μ μ 체 λ°μ΄ν°μ μ κ·Όνμ¬ μλ‘μ΄ μ μΉλ£μ μ λ³΄λ€ ν¨μ¨μ μΈ μμ κ°λ°μ μ§μν μ μλλ‘ ν©λλ€. |
| With that, I will now turn the call over to AmirAli for an update on screening. AmirAli Talasaz Co-CEO & Director Thanks, Helmy. Moving on to Slide 12. Shield has delivered extraordinary growth since launch. We delivered $35 million of Shield testing revenue in Q4, driven by approximately 38,000 tests, which was a meaningful step-up compared to 24,000 tests in Q3. Revenue growth has closely tracked volume growth, reflecting ADLT pricing, favorable collections and a disciplined focus on reimbursable lives. | **μ¬νμ:** κ·ΈλΌ μ΄μ , μ€ν¬λ¦¬λ νν© μ
λ°μ΄νΈλ₯Ό μν΄ μλ―Έλ₯΄μ리μκ² λ§μ΄ν¬λ₯Ό λκΈ°κ² μ΅λλ€. **μλ―Έλ₯΄μ리 νλΌμ¬μ¦ 곡λ CEO κ²Έ μ΄μ¬:** ν¬λ―Έλ, κ°μ¬ν©λλ€. μ¬λΌμ΄λ 12λ‘ λμ΄κ°κ² μ΅λλ€. Shieldλ μΆμ μ΄ν κ΄λͺ©ν λ§ν μ±μ₯μΈλ₯Ό 보μμ΅λλ€. λΉμ¬λ 4λΆκΈ°μ Shield κ²μ¬ λ§€μΆ 3,500λ§ λ¬λ¬λ₯Ό κΈ°λ‘νμΌλ©°, μ΄λ μ½ 3λ§ 8μ² κ±΄μ κ²μ¬λμ νμ μ κ²μ λλ€. μ΄λ 3λΆκΈ°μ 2λ§ 4μ² κ±΄ λλΉ ν¬κ² μ¦κ°ν μμΉμ λλ€. λ§€μΆ μ±μ₯μ κ²μ¬λ μ¦κ°μ λ°μ νκ² μ°λλμμΌλ©°, μ΄λ ADLT κ°κ²© μ± μ , μ°νΈμ μΈ μκΈ, κ·Έλ¦¬κ³ λ³΄ν μ μ© λμμ λν 체κ³μ μΈ μ§μ€μ κ²°κ³Όμ λλ€. |
| Based on performance to date, we believe Shield is the most successful diagnostic launch in history outside of COVID testing and is positioned to be a significant multiyear growth driver for Guardant. Now turning to Slide 13 to take a closer look at screening highlights for the fourth quarter of 2025. Shield had strong sequential growth in Q4, driven by growing demand from both patients and physicians. Adherence rates remained high, reinforcing the accessibility and convenience of blood-based screening. To support the growing demand, we continue to scale our commercial organization throughout 2025, exiting the year with approximately 300 sales reps. | νμ¬κΉμ§μ μ€μ μ λ°νμΌλ‘, Shieldλ μ½λ‘λ19 κ²μ¬λ₯Ό μ μΈνκ³ μμ¬μ κ°μ₯ μ±κ³΅μ μΈ μ§λ¨ μ ν μΆμμ΄λ©°, Guardantμ μλΉν λ€λ κ° μ±μ₯ λλ ₯μ΄ λ κ²μΌλ‘ μμλ©λλ€. μ΄μ 13νμ΄μ§λ‘ λμ΄κ° 2025λ 4λΆκΈ° μ€ν¬λ¦¬λ μ£Όμ λ΄μ©μ μμΈν μ΄ν΄λ³΄κ² μ΅λλ€. Shieldλ νμμ μμ¬ μμΈ‘μ μμ μ¦κ°μ νμ μ΄ 4λΆκΈ°μ κ°λ ₯ν μμ°¨μ μ±μ₯μ κΈ°λ‘νμ΅λλ€. νμ‘ κΈ°λ° μ€ν¬λ¦¬λμ μ κ·Όμ±κ³Ό νΈμμ±μ μ μ¦νλ―, μμλ(adherence rates)λ λκ² μ μ§λμμ΅λλ€. μ¦κ°νλ μμλ₯Ό μ§μνκΈ° μν΄, μ ν¬λ 2025λ λ΄λ΄ μμ μ‘°μ§μ κ³μ νμ₯νμ¬, μ°λ§μλ μ½ 300λͺ μ μμ λ΄λΉμλ₯Ό ν보νμ΅λλ€. |
| Last month, we received coverage from TRICARE for active duty service members and their families with no co-pay. TRICARE will cover Shield for all eligible average-risk individuals aged 45 and older. In Q4, we launched a dedicated health systems team, and we are excited to report that we have successfully deployed our first enterprise scale integrations with large health systems in West Virginia and Georgia. We are excited by the early progress demonstrating the market demand and our ability to operationalize Shield within complex health systems, including full EMR integration and workflow deployment. | μ§λλ¬, TRICAREλ‘λΆν° νμ κ΅°μΈ λ° κ·Έ κ°μ‘±λ€μ μν 보μ₯μ λ³ΈμΈ λΆλ΄κΈ μμ΄ λ°κ² λμμ΅λλ€. TRICAREλ 45μΈ μ΄μμ λͺ¨λ μ 격ν νκ· μνκ΅° κ°μΈλ€μκ² Shieldλ₯Ό 보μ₯ν μμ μ λλ€. 4λΆκΈ°μ μ ν¬λ μ λ΄ ν¬μ€μΌμ΄ μμ€ν νμ μΆλ²μμΌ°κ³ , μ¨μ€νΈλ²μ§λμμ μ‘°μ§μμ λν ν¬μ€μΌμ΄ μμ€ν λ€κ³Ό 첫 λ²μ§Έ μν°νλΌμ΄μ¦κΈ ν΅ν©μ μ±κ³΅μ μΌλ‘ λ°°ν¬νμμ κΈ°μκ² λ³΄κ³ λ립λλ€. μ ν¬λ μ΄λ¬ν μ΄κΈ° μ§μ μ κ³ λ¬΄λμ΄ μμΌλ©°, μ΄λ μμ₯ μμμ λλΆμ΄ μμ ν EMR ν΅ν© λ° μν¬νλ‘μ° λ°°ν¬λ₯Ό ν¬ν¨ν 볡μ‘ν ν¬μ€μΌμ΄ μμ€ν λ΄μμ Shieldλ₯Ό ν¨κ³Όμ μΌλ‘ μ΄μν μ μλ μ ν¬μ μλμ μ μ¦ν©λλ€. |
| Beyond CRC, we are excited to expand Shield to include multi-cancer detection results reported in October. Although still early days, we are encouraged with physicians' enthusiasm to get access to MCD findings and strong interest by patients to be part of the MCD data collection initiative. Turning to Slide 14. We are very encouraged by Shield's real-world adherence, which reached 93% across the first 100,000 Shield test ordered. In other words, when physicians order Shield for CRC screening, 93% of patients completed the test. This represents a meaningful improvement compared to other screening modalities where adherence typically ranges from 25% to 71%. | λμ₯μ κ²μ§μ λμ΄, 10μμ λ°νλ λ€μ€ μ νμ§(MCD) κ²°κ³ΌκΉμ§ Shieldλ₯Ό νμ₯νκ² λμ΄ κΈ°λκ° ν½λλ€. μμ§ μ΄κΈ° λ¨κ³μμλ λΆκ΅¬νκ³ , μλ£μ§μ΄ MCD κ²°κ³Όλ₯Ό μ μνλ €λ μ΄μμ νμλ€μ΄ MCD λ°μ΄ν° μμ§ μ΄λμ
ν°λΈμ μ κ·Ήμ μΌλ‘ μ°Έμ¬νλ €λ λμ κ΄μ¬μ κ³ λ¬΄λμ΄ μμ΅λλ€. μ¬λΌμ΄λ 14λ‘ λμ΄κ°κ² μ΅λλ€. μ²μ μ£Όλ¬Έλ 10λ§ κ±΄μ Shield κ²μ¬μμ 93%μ λ¬νλ Shieldμ μ€μ¬μ© μμλμ λ§€μ° κ³ λ¬΄λμ΄ μμ΅λλ€. λ€μ λ§ν΄, μλ£μ§μ΄ λμ₯μ κ²μ§μ μν΄ Shieldλ₯Ό μ²λ°©νμ λ, νμμ 93%κ° κ²μ¬λ₯Ό μλ£νμ΅λλ€. μ΄λ μμλκ° μΌλ°μ μΌλ‘ 25%μμ 71% λ²μμ 머무λ λ€λ₯Έ κ²μ§ λ°©μκ³Ό λΉκ΅νμ λ μλΉν κ°μ μ μλ―Έν©λλ€. |
| As we illustrated in the patient story earlier, the ability to complete the Shield test during an office visit removes key barriers and enables far more patients to complete their CRC screening. Taking a closer look at our recent strategic collaborations to scale our commercial infrastructure on Slide 15. We are excited to announce collaborations with Quest Diagnostics and PA Group, which will broaden our national reach in 2026. | μμ νμ μ¬λ‘μμ μ€λͺ
λλ Έλ―μ΄, μ§λ£μ€ λ°©λ¬Έ μ Shield ν
μ€νΈλ₯Ό μλ£ν μ μλ€λ μ μ μ£Όμ μ₯λ²½μ μ κ±°νκ³ ν¨μ¬ λ λ§μ νμλ€μ΄ λμ₯μ κ²μ§(CRC screening)μ μλ£ν μ μλλ‘ ν©λλ€. μ¬λΌμ΄λ 15μμ λΉμ¬μ μμ μ μΈνλΌ νμ₯μ μν μ΅κ·Ό μ λ΅μ νλ ₯ μ¬λ‘λ€μ μ’ λ μμΈν μ΄ν΄λ³΄κ² μ΅λλ€. μ ν¬λ Quest Diagnostics λ° PA Groupκ³Όμ νλ ₯μ λ°ννκ² λμ΄ κΈ°μκ² μκ°νλ©°, μ΄λ 2026λ μ λΉμ¬μ μ κ΅μ μΈ λλ¬ λ²μλ₯Ό νλνλ λ° κΈ°μ¬ν κ²μ λλ€. |
| Our collaboration with Quest enables access to their national sales organization and allows providers to order Shield and receive results directly through the Quest connectivity system, which was used by approximately 650,000 clinicians and hospital accounts last year. We remain on track to launch this collaboration later this quarter. The PathGroup collaboration went live in the fourth quarter and expands Shield's reach to more than 250 health systems across 25 states. We look forward to seeing the positive impact of our growing commercial infrastructure in 2026 and years to come. Moving on to Slide 16. | νμ€νΈμμ νλ ₯μ ν΅ν΄ κ·Έλ€μ μ κ΅ μμ μ‘°μ§μ νμ©ν μ μκ² λμμΌλ©°, μλ£κΈ°κ΄λ€μ μλ μ μ½ 65λ§ λͺ μ μμμμ λ³μ κ³μ μμ μ¬μ©λ νμ€νΈ μ°κ²° μμ€ν μ ν΅ν΄ Shieldλ₯Ό μ£Όλ¬Ένκ³ κ²°κ³Όλ₯Ό μ§μ μλ Ήν μ μκ² λ©λλ€. μ°λ¦¬λ μ΄λ² λΆκΈ° λ§μ μ΄ νλ ₯μ μμν κ³νμ΄λ©°, μμ‘°λ‘κ² μ§νλκ³ μμ΅λλ€. ν¨μ€κ·Έλ£Ήκ³Όμ νλ ₯μ 4λΆκΈ°μ κ°λμ μμνμΌλ©°, 25κ° μ£Όμ κ±Έμ³ 250κ° μ΄μμ μλ£ μμ€ν μΌλ‘ Shieldμ λλ¬ λ²μλ₯Ό νμ₯ν©λλ€. μ°λ¦¬λ 2026λ κ³Ό κ·Έ μ΄ν μλ κ° μ°λ¦¬μ μ±μ₯νλ μμ μΈνλΌκ° κ°μ Έμ¬ κΈμ μ μΈ μν₯μ κΈ°λνκ³ μμ΅λλ€. μ¬λΌμ΄λ 16μΌλ‘ λμ΄κ°κ² μ΅λλ€. |
| Our goal has always been to detect many cancer types early when they are most treatable. With that in mind, we developed Shield as a multi-cancer detection platform. Turning to Slide 17. In fourth quarter, we expanded Shield to include a multi-cancer results report, which includes findings for 9 of the most common cancers in addition to CRC. With each positive MCD finding, the report includes a cancer site of origin or CSO color, which provides tumor-specific information, giving more clear guidance to physicians for subsequent diagnostic workup. The Shield MCD report is available to Shield CRC patients who opt in and authorized the release of their medical data to Guardant. | μ°λ¦¬μ λͺ©νλ νμ μΉλ£ κ°λ₯μ±μ΄ κ°μ₯ λμ λ λ§μ μ μ νμ μ‘°κΈ°μ λ°κ²¬νλ κ²μ΄μμ΅λλ€. μ΄λ₯Ό μΌλμ λκ³ , μ ν¬λ Shieldλ₯Ό λ€μ€ μ μ‘°κΈ° μ§λ¨ νλ«νΌμΌλ‘ κ°λ°νμ΅λλ€. 17λ² μ¬λΌμ΄λλ₯Ό 보μλ©΄, 4λΆκΈ°μ μ ν¬λ Shieldλ₯Ό νμ₯νμ¬ CRC(λμ₯μ) μΈμλ κ°μ₯ νν 9κ°μ§ μμ λν κ²°κ³Όλ₯Ό ν¬ν¨νλ λ€μ€ μ κ²°κ³Ό λ³΄κ³ μλ₯Ό μΆκ°νμ΅λλ€. κ°κ°μ μμ± MCD(λ€μ€ μ μ‘°κΈ° μ§λ¨) κ²°κ³Όμ ν¨κ», λ³΄κ³ μμλ μ μλ° λΆμ(CSO) μμμ΄ ν¬ν¨λμ΄ μ’ μ νΉμ΄μ μ 보λ₯Ό μ 곡νλ©°, μ΄λ μμ¬λ€μ΄ νμ μ§λ¨ κ²μ¬λ₯Ό μ§ννλ λ° λ λͺ νν μ§μΉ¨μ μ 곡ν©λλ€. Shield MCD λ³΄κ³ μλ Guardantμ μλ£ λ°μ΄ν° 곡κ°λ₯Ό λμνκ³ μΉμΈν Shield CRC νμλ€μκ² μ 곡λ©λλ€. |
| As a result of this initiative, we expect our Shield data repository to grow exponentially, and we look forward to leveraging this high-quality data to support reimbursement and regulatory approvals, drive a deeper understanding of clinical utility and support future technology improvements. We are encouraged to see the recent passage of legislation establishing a Medicare coverage pathway for multi-cancer detection tests. While this is not expected to be a meaningful driver of our business in the near term, we view this as a positive step forward for the field. Turning to Slide 18. | μ΄ μ΄λμ ν°λΈμ κ²°κ³Όλ‘, μ ν¬ Shield λ°μ΄ν° μ μ₯μλ κΈ°νκΈμμ μΌλ‘ μ±μ₯ν κ²μΌλ‘ μμλ©λλ€. μ ν¬λ μ΄ κ³ νμ§ λ°μ΄ν°λ₯Ό νμ©νμ¬ λ³΄ν μν λ° κ·μ μΉμΈμ μ§μνκ³ , μμμ μ μ©μ±μ λν λ κΉμ μ΄ν΄λ₯Ό μ΄μ§νλ©°, λ―Έλ κΈ°μ κ°μ μ μ§μν μ μκΈ°λ₯Ό κΈ°λν©λλ€. μ΅κ·Ό λ€μ€ μ κ²μ¬λ₯Ό μν λ©λμΌμ΄ 보μ₯ κ²½λ‘λ₯Ό ν립νλ λ²μμ΄ ν΅κ³Όλ κ²μ λ³΄κ² λμ΄ κ³ λ¬΄μ μ λλ€. μ΄κ²μ΄ λ¨κΈ°μ μΌλ‘ μ ν¬ μ¬μ μ μλ―Έ μλ λλ ₯μ΄ λ κ²μΌλ‘ μμλμ§λ μμ§λ§, μ ν¬λ μ΄κ²μ ν΄λΉ λΆμΌμ κΈμ μ μΈ μ§μ μΌλ‘ λ³΄κ³ μμ΅λλ€. 18νμ΄μ§λ‘ λμ΄κ°κ² μ΅λλ€. |
| Our outstanding commercial performance in 2025 reflected in rapidly growing revenue was driven by several factors. We achieved ADLT status for Shield, securing a $1,495 reimbursement rate that supports healthy ASP and gross profit, enabling us to reinvest in commercial expansion. We also benefited from meaningful first-mover advantage and clear product market fit, which drove broad provider adoption. Our best-in-class commercial execution, continued progress with EMR integration, inclusion in NCCN guidelines were additional key contributors to our growth trajectory in 2025. We believe these foundational achievements position Shield for continued strong growth ahead. | 2025λ
κΈμ¦νλ λ§€μΆλ‘ λνλ λΉμ¬μ νμν μ¬μ
μ±κ³Όλ μ¬λ¬ μμΈμ νμ
μ λ° ν½λλ€. λΉμ¬λ Shieldμ λν ADLT μ§μλ₯Ό νλνμ¬, 건μ ν ASP(νκ· νλ§€ κ°κ²©)μ μ΄μ΄μ΅μ λ·λ°μΉ¨νλ 1,495λ¬λ¬μ μνμ¨μ ν보νμ΅λλ€. μ΄λ μμ
μ νμ₯μ μ¬ν¬μν μ μλ κΈ°λ°μ΄ λμμ΅λλ€. λν, λΉμ¬λ μλΉν μ μ μ°μμ λͺ νν μ ν μμ₯ μ ν©μ±μΌλ‘λΆν° μ΄μ μ μ»μμΌλ©°, μ΄λ κ΄λ²μν 곡κΈμ 체 μ±νμΌλ‘ μ΄μ΄μ‘μ΅λλ€. λΉμ¬μ λμ’ μ κ³ μ΅κ³ μμ€μ μμ μ μ€νλ ₯, EMR ν΅ν©μ μ§μμ μΈ μ§μ , κ·Έλ¦¬κ³ NCCN κ°μ΄λλΌμΈ ν¬ν¨ λν 2025λ λΉμ¬μ μ±μ₯ κΆ€λμ μ€μν κΈ°μ¬λ₯Ό νμ΅λλ€. λΉμ¬λ μ΄λ¬ν ν λμ μΈ μ±κ³Όλ€μ΄ Shieldκ° μμΌλ‘λ μ§μμ μΈ κ°λ ₯ν μ±μ₯μ μ΄μ΄κ° μ μλ κΈ°λ°μ λ§λ ¨νλ€κ³ λ―Ώμ΅λλ€. |
| Looking more closely at our 2026 setup, the ADLT rate of $1,495 has now been incorporated into the clinical lab fee schedule and is secured through December 2027. We also expect to see benefits from our collaboration with Quest and PathGroup alongside the continued expansion of our field force throughout the year. Additional growth drivers include ACS guideline inclusion, targeted direct-to-consumer campaign launches and the expansion of sales phase Shield into select markets outside the U.S. Turning to Slide 19. We continue to invest aggressively in R&D to improve our product performance. As part of that process, we have rigorously evaluated dozens of external technologies over the years. | 2026λ
μ¬μ
κΈ°λ°μ μ’ λ μμΈν μ΄ν΄λ³΄λ©΄, 1,495λ¬λ¬μ ADLT μμ¨μ΄ μ΄μ μμ κ²μ¬ μκ°νμ νΈμ
λμμΌλ©°, 2027λ
12μκΉμ§ 보μ₯λ©λλ€. λν, Quest λ° PathGroupκ³Όμ νλ ₯μ ν΅ν΄ μ»μ μ μλ μ΄μ κ³Ό λλΆμ΄, μ¬ν΄ λ΄λ΄ μμ
μΈλ ₯μ μ§μμ μΈ νλλ₯Ό κΈ°λνκ³ μμ΅λλ€. μΆκ°μ μΈ μ±μ₯ λλ ₯μΌλ‘λ ACS κ°μ΄λλΌμΈ νΈμ
, νκ²ν
λ μλΉμ μ§μ νλ§€(D2C) μΊ νμΈ μΆμ, κ·Έλ¦¬κ³ λ―Έκ΅ μΈ μΌλΆ μμ₯μΌλ‘μ Shield μ ν νλ§€ νλκ° μμ΅λλ€. μ¬λΌμ΄λ 19λ₯Ό 보μκ² μ΅λλ€. μ ν¬λ μ ν μ±λ₯ ν₯μμ μν΄ R&Dμ κ³μν΄μ μ κ·Ήμ μΌλ‘ ν¬μνκ³ μμ΅λλ€. μ΄λ¬ν κ³Όμ μ μΌνμΌλ‘, μ ν¬λ μλ κ° μμ κ°μ μΈλΆ κΈ°μ μ μ² μ ν νκ°ν΄μμ΅λλ€. |
| We recently completed the acquisition of MetaSight Diagnostics, which brings a new technology in-house that is complementary to the Smart Platform and also brings on an impressive team, further strengthening our world-class R&D organization. We are excited for the technology's potential to enhance our CRC screening, [Audio Gap] multi-cancer detection and ultimately, the entirety of our oncology product portfolio. It also has the potential to accelerate our multi-disease detection pipeline. With that, I will now turn the call over to Mike for more detail on our financials. Michael Bell Chief Financial Officer Thanks, AmirAli. Turning to Slide 20. | μ ν¬λ μ΅κ·Ό MetaSight Diagnostics μΈμλ₯Ό μλ£νμ΅λλ€. μ΄λ₯Ό ν΅ν΄ Smart νλ«νΌκ³Ό μνΈ λ³΄μμ μΈ μλ‘μ΄ κΈ°μ μ μ¬λ΄μ λμ
νκ³ , μΈμμ μΈ νμ ν©λ₯μμΌ μ ν¬μ μΈκ³μ μμ€μ R&D μ‘°μ§μ λμ± κ°ννκ² λμμ΅λλ€. μ ν¬λ μ΄ κΈ°μ μ΄ μ ν¬μ CRC(λμ₯μ) κ²μ§, [μμ± λκΉ] λ€μ€ μ μ§λ¨, κ·Έλ¦¬κ³ κΆκ·Ήμ μΌλ‘λ μ ν¬μ μ 체 μ’
μν μ ν ν¬νΈν΄λ¦¬μ€λ₯Ό ν₯μμν¬ μ μ¬λ ₯μ λν΄ λ§€μ° κΈ°λνκ³ μμ΅λλ€. λν, μ΄λ μ ν¬μ λ€μ€ μ§λ³ μ§λ¨ νμ΄νλΌμΈμ κ°μνν μ μ¬λ ₯λ κ°μ§κ³ μμ΅λλ€. μ΄μ ν¨κ», μ ν¬ μ¬λ¬΄μ λν λ μμΈν λ΄μ©μ μν΄ λ§μ΄ν¬μκ² λ°μΈκΆμ λκΈ°κ² μ΅λλ€. **λ§μ΄ν΄ 벨** μ΅κ³ μ¬λ¬΄ μ± μμ μλ―Έλ₯΄μ리λ, κ°μ¬ν©λλ€. 20νμ΄μ§λ₯Ό 보μκ² μ΅λλ€. |
| I'll review select financial highlights for the quarter and full year ended December 31, 2025. Unless otherwise noted, all growth rates are year-over-year. Total revenue in the fourth quarter increased 39% to $281.3 million, reflecting strong execution across oncology, biopharma and data and screening. Oncology revenue increased 30% to $189.9 million, driven by continued strong volume growth. We reported approximately 79,000 oncology tests in Q4, up 38%, demonstrating sustained momentum across the portfolio. | 2025λ
12μ 31μΌ λ§κ°λ λΆκΈ° λ° μ°κ° μ£Όμ μ¬λ¬΄ μ±κ³Όλ₯Ό μ΄ν΄λ³΄κ² μ΅λλ€. λ³λλ‘ λͺ
μλμ§ μλ ν, λͺ¨λ μ±μ₯λ₯ μ μ λ
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λλ€. 4λΆκΈ° μ΄ λ§€μΆμ 39% μ¦κ°ν 2μ΅ 8,130λ§ λ¬λ¬λ₯Ό κΈ°λ‘νμΌλ©°, μ΄λ μ’ μν, λ°μ΄μ€ μ μ½, λ°μ΄ν° λ° μ€ν¬λ¦¬λ λΆμΌ μ λ°μ κ±ΈμΉ κ°λ ₯ν μ€νλ ₯μ νμ μ κ²°κ³Όμ λλ€. μ’ μν λΆλ¬Έ λ§€μΆμ μ§μμ μΈ λμ λ¬Όλ μ¦κ°μ νμ μ΄ 30% μ¦κ°ν 1μ΅ 8,990λ§ λ¬λ¬λ₯Ό κΈ°λ‘νμ΅λλ€. μ ν¬λ 4λΆκΈ°μ μ½ 79,000건μ μ’ μν κ²μ¬λ₯Ό κΈ°λ‘νμΌλ©°, μ΄λ 38% μ¦κ°ν μμΉλ‘, ν¬νΈν΄λ¦¬μ€ μ λ°μ κ±Έμ³ μ§μμ μΈ λͺ¨λ©ν μ μ μ¦νκ³ μμ΅λλ€. |
| Guardant360 liquid volumes increased nearly 30%, supported by expanding clinical utility from Smart apps launched over the past year, and Guardant360 tissue remains strong following the major upgrade introduced in Q2. Reveal continued to be our fastest-growing oncology product, benefiting from CRC surveillance reimbursement and ongoing strength in breast and lung cancer. We were also encouraged by the early uptake of Reveal for late-stage therapy response monitoring launched in Q4. Average selling prices were stable sequentially with Guardant360 liquid in the range of $3,000 to $3,100, Guardant360 Tissue approximately $2,000 and Reveal between $600 and $700. | μ§λ ν ν΄ λμ μΆμλ Smart μ±μ ν΅ν μμμ μ μ©μ± νλμ νμ
μ΄ Guardant360 liquid κ²μ¬λμ μ½ 30% μ¦κ°νμ΅λλ€. λν, 2λΆκΈ°μ λμ
λ μ£Όμ μ
κ·Έλ μ΄λ μ΄ν Guardant360 tissue κ²μ¬λ 견쑰ν νλ¦μ μ μ§νκ³ μμ΅λλ€. Revealμ CRC(λμ₯μ) κ°μ κ²μ¬ κΈμ¬ μ μ©κ³Ό μ λ°©μ λ° νμ λΆμΌμμμ μ§μμ μΈ κ°μΈμ νμ μ΄ λΉμ¬μ κ°μ₯ λΉ λ₯΄κ² μ±μ₯νλ μ’ μν μ νμΌλ‘ μ리맀κΉνκ³ μμ΅λλ€. λν, 4λΆκΈ°μ μΆμλ νκΈ° λ¨κ³ μΉλ£ λ°μ λͺ¨λν°λ§μ μν Revealμ μ΄κΈ° μ±νλ₯ μλ κ³ λ¬΄λμμ΅λλ€. νκ· νλ§€ κ°κ²©μ μ λΆκΈ° λλΉ μμ μ μ΄μμΌλ©°, Guardant360 liquidλ 3,000λ¬λ¬μμ 3,100λ¬λ¬ λ²μ, Guardant360 Tissueλ μ½ 2,000λ¬λ¬, Revealμ 600λ¬λ¬μμ 700λ¬λ¬ μ¬μ΄μμ΅λλ€. |
| As a reminder, we've submitted data packages to MolDx for Medicare reimbursement covering breast MRD and both immunotherapy and chemotherapy response monitoring. Successful outcomes will provide upside to Reveal ASP. Biopharma and data revenue was $54.0 million, up 9%, which was in line with our expectations. Screening revenue totaled $35.1 million from approximately 38,000 Shield tests. Shield ASP was approximately $850, consistent with expectations and reflecting our focus on Medicare covered patients. Out-of-period revenue totaled approximately $18 million for the fourth quarter of 2025, including approximately $3 million related to screening. | μκΈ°μμΌ λ리μλ©΄, μ ν¬λ μ λ°©μ MRD(λ―ΈμΈμμ‘΄μ§ν) λ° λ©΄μμΉλ£μ ννμλ² λ°μ λͺ¨λν°λ§ λͺ¨λλ₯Ό ν¬ν¨νλ λ©λμΌμ΄ μνμ μν λ°μ΄ν° ν¨ν€μ§λ₯Ό MolDxμ μ μΆνμ΅λλ€. μ±κ³΅μ μΈ κ²°κ³Όλ Reveal ASP(νκ· νλ§€ κ°κ²©)μ μμΉ μ¬λ ₯μ μ 곡ν κ²μ
λλ€. λ°μ΄μ€νλ§ λ° λ°μ΄ν° λ§€μΆμ 5,400λ§ λ¬λ¬λ‘ 9% μ¦κ°νμΌλ©°, μ΄λ μ ν¬μ μμμΉμ λΆν©νμ΅λλ€. μ λ³ κ²μ¬ λ§€μΆμ μ½ 38,000건μ Shield κ²μ¬λ₯Ό ν΅ν΄ μ΄ 3,510λ§ λ¬λ¬λ₯Ό κΈ°λ‘νμ΅λλ€. Shield ASPλ μ½ 850λ¬λ¬λ‘ μμμΉμ μΌμΉνμΌλ©°, μ΄λ λ©λμΌμ΄ μ μ© νμμ λν μ ν¬μ μ§μ€μ λ°μν©λλ€. κΈ°κ° μΈ λ§€μΆμ 2025λ 4λΆκΈ°μ μ΄ μ½ 1,800λ§ λ¬λ¬λ₯Ό κΈ°λ‘νμΌλ©°, μ΄ μ€ μ½ 300λ§ λ¬λ¬λ μ λ³ κ²μ¬μ κ΄λ ¨λ κ²μ΄μμ΅λλ€. |
| This was in line with prior periods compared to approximately $17 million in both the third quarter of 2025 and the fourth quarter of 2024. For the full year, total revenue grew 33% to $982.0 million. Oncology revenue increased 26% to $683.6 million. We reported approximately 276,000 oncology tests, representing 34% growth. Guardant360 volume growth accelerated to 25% for the year, driven by continued smart app adoption. Guardant360 tissue volumes strengthened in the second half following the Smart Platform upgrade and Reveal remained our fastest-growing oncology product throughout the year. Biopharma and data revenue grew 18% to $210.1 million. | μ΄λ 2025λ 3λΆκΈ°μ 2024λ 4λΆκΈ° κ°κ° μ½ 1,700λ§ λ¬λ¬λ₯Ό κΈ°λ‘νλ μ΄μ κΈ°κ°κ³Ό λΉμ·ν μμ€μ΄μμ΅λλ€. μ°κ° μ΄ λ§€μΆμ 33% μ±μ₯νμ¬ 9μ΅ 8,200λ§ λ¬λ¬λ₯Ό κΈ°λ‘νμ΅λλ€. μ’ μν λ§€μΆμ 26% μ¦κ°ν 6μ΅ 8,360λ§ λ¬λ¬λ₯Ό κΈ°λ‘νμ΅λλ€. λΉμ¬λ μ½ 27λ§ 6μ² κ±΄μ μ’ μν κ²μ¬λ₯Ό λ³΄κ³ νμΌλ©°, μ΄λ 34% μ±μ₯ν μμΉμ λλ€. Guardant360 κ²μ¬λ μ±μ₯μ μ§μμ μΈ μ€λ§νΈ μ± μ±νμ νμ μ΄ μ°κ° 25%λ‘ κ°μνλμμ΅λλ€. Guardant360 μ‘°μ§ κ²μ¬λμ μ€λ§νΈ νλ«νΌ μ κ·Έλ μ΄λ μ΄ν νλ°κΈ°μ μ¦κ°νμΌλ©°, Revealμ μ°μ€ λ΄λ΄ λΉμ¬μ κ°μ₯ λΉ λ₯΄κ² μ±μ₯νλ μ’ μν μ νμΌλ‘ μ리맀κΉνμ΅λλ€. λ°μ΄μ€νλ§ λ° λ°μ΄ν° λ§€μΆμ 18% μ±μ₯ν 2μ΅ 1,010λ§ λ¬λ¬λ₯Ό κΈ°λ‘νμ΅λλ€. |
| Finally, screening revenue totaled $79.7 million in our first full calendar year since launch, generated from approximately 87,000 Shield tests. Turning to Slide 21. Non-GAAP gross margin improved to 66% in Q4 compared to 63% in the prior year. For the full year, non-GAAP gross margin increased to 66%, up from 62% in 2024. This improvement was primarily driven by a significant reduction in Reveal cost per test, which improved from over $1,000 in Q3 2024 to under $500 throughout 2025. We also made meaningful progress improving Shield gross margins. Shield's non-GAAP gross margin improved from negative levels at launch to 52% in Q4 2025. | λ§μ§λ§μΌλ‘, μ λ³ κ²μ¬ λ§€μΆμ μΆμ μ΄ν 첫 μμ ν μλ
λμ μ½ 87,000건μ Shield κ²μ¬λ₯Ό ν΅ν΄ μ΄ 7,970λ§ λ¬λ¬λ₯Ό κΈ°λ‘νμ΅λλ€. λ€μμΌλ‘ μ¬λΌμ΄λ 21μ 보μκ² μ΅λλ€. λΉGAAP λ§€μΆ μ΄μ΄μ΅λ₯ μ 4λΆκΈ°μ μ λ λκΈ° 63% λλΉ κ°μ λμ΄ 66%λ₯Ό κΈ°λ‘νμ΅λλ€. μ°κ°μΌλ‘λ λΉGAAP λ§€μΆ μ΄μ΄μ΅λ₯ μ΄ 2024λ 62%μμ μμΉνμ¬ 66%λ‘ μ¦κ°νμ΅λλ€. μ΄λ¬ν κ°μ μ μ£Όλ‘ Reveal κ²μ¬λΉ λΉμ©μ μλΉν κ°μμ κΈ°μΈνλ©°, μ΄λ 2024λ 3λΆκΈ° 1,000λ¬λ¬ μ΄μμμ 2025λ λ΄λ΄ 500λ¬λ¬ λ―Έλ§μΌλ‘ κ°μ λμμ΅λλ€. λν μ ν¬λ Shield λ§€μΆ μ΄μ΄μ΅λ₯ κ°μ μλ μλ―Έ μλ μ§μ μ μ΄λ£¨μμ΅λλ€. Shieldμ λΉGAAP λ§€μΆ μ΄μ΄μ΅λ₯ μ μΆμ λΉμ λ§μ΄λμ€ μμ€μμ κ°μ λμ΄ 2025λ 4λΆκΈ°μλ 52%λ₯Ό κΈ°λ‘νμ΅λλ€. |
| This reflects strong ASPs under the Medicare ADLT rate, disciplined focus on reimbursable testing and continued volume-driven cost reduction. Shield cost per test declined sequentially and exited the year at approximately $450, in line with our operational plan. Non-GAAP operating expenses were $260.0 million in Q4, up 21% and $903.7 million for the full year, up 19%. Full year operating expense was modestly above guidance due to 2 Q4 items. Firstly, an increase in accrual for the 2025 company bonus plan, which reflects the strong performance in the year across financial, regulatory and commercial milestones. | μ΄λ λ©λμΌμ΄ ADLT μμ¨μ λ°λ₯Έ 견쑰ν ASP, 보ν μ μ© κ²μ¬μ λν 체κ³μ μΈ μ§μ€, κ·Έλ¦¬κ³ μ§μμ μΈ λ¬Όλ μ¦κ°μ λ°λ₯Έ λΉμ© μ κ°μ λ°μν©λλ€. μ΄λ κ²μ¬λΉ λΉμ©μ μ λΆκΈ° λλΉ κ°μνμ¬, μ°λ§ κΈ°μ€ μ½ 450λ¬λ¬λ₯Ό κΈ°λ‘νλ©° λΉμ¬μ μ΄μ κ³νμ λΆν©νμ΅λλ€. λΉGAAP μμ λΉμ©μ 4λΆκΈ°μ 2μ΅ 6μ²λ§ λ¬λ¬λ‘ 21% μ¦κ°νμΌλ©°, μ°κ°μΌλ‘λ 9μ΅ 370λ§ λ¬λ¬λ‘ 19% μ¦κ°νμ΅λλ€. μ°κ° μμ λΉμ©μ 4λΆκΈ° λ κ°μ§ μμΈμΌλ‘ μΈν΄ κ°μ΄λμ€λ₯Ό μν μννμ΅λλ€. 첫째, 2025λ νμ¬ λ³΄λμ€ κ³νμ λν μΆ©λΉκΈ μ¦κ°μ λλ€. μ΄λ μ¬λ¬΄, κ·μ λ° μμ μ μ΄μ ν μ λ°μ κ±Έμ³ μ¬ν΄μ 견쑰ν μ€μ μ λ°μν©λλ€. |
| Secondly, the continued reinvestment of incremental screening gross profit into sales and marketing to accelerate our commercial build-out. Adjusted EBITDA loss improved to $64.9 million in Q4 compared to $78.4 million in the prior year quarter. For the full year, adjusted EBITDA loss improved to $220.9 million versus $257.5 million in 2024. Turning to Slide 22. We continue to improve cash performance in 2025. Free cash flow burn was $233 million for the year, an improvement of $42 million and in line with our guidance. Importantly, excluding screening, the core business generated positive free cash flow in both Q3 and Q4. | λμ§Έλ‘, μ¦κ°λ μ€ν¬λ¦¬λ λ§€μΆμ΄μ΄μ΅μ μμ
λ° λ§μΌν
μ μ§μμ μΌλ‘ μ¬ν¬μνμ¬ μ¬μ
νμ₯μ κ°μννκ³ μμ΅λλ€. μ‘°μ EBITDA μμ€μ 4λΆκΈ°μ 6,490λ§ λ¬λ¬λ‘ κ°μ λμμΌλ©°, μ΄λ μ λ λκΈ°μ 7,840λ§ λ¬λ¬μ λΉκ΅λ©λλ€. μ°κ°μΌλ‘λ μ‘°μ EBITDA μμ€μ΄ 2024λ μ 2μ΅ 5,750λ§ λ¬λ¬ λλΉ 2μ΅ 2,090λ§ λ¬λ¬λ‘ κ°μ λμμ΅λλ€. 22λ² μ¬λΌμ΄λλ₯Ό 보μκ² μ΅λλ€. 2025λ μλ νκΈ μ€μ μ μ§μμ μΌλ‘ κ°μ νμ΅λλ€. μ°κ° μμ¬νκΈνλ¦ μμ§μ‘μ 2μ΅ 3,300λ§ λ¬λ¬λ‘, 4,200λ§ λ¬λ¬ κ°μ λ μμΉμ΄λ©° λΉμ¬μ κ°μ΄λμ€μ λΆν©ν©λλ€. νΉν, μ€ν¬λ¦¬λμ μ μΈν ν΅μ¬ μ¬μ μ 3λΆκΈ°μ 4λΆκΈ° λͺ¨λ κΈμ μ μΈ μμ¬νκΈνλ¦μ μ°½μΆνμ΅λλ€. |
| We expect the core business to be free cash flow positive for the full year 2026 and remain committed to achieving company-wide cash flow breakeven by the end of 2027. As AmirAli mentioned, in December, we acquired MetaSight for $59 million in upfront cash plus up to $90 million in contingent consideration tied to future commercial and regulatory milestones. We believe this technology enhances our existing product portfolio and accelerates our multi-disease detection pipeline. | μ ν¬λ ν΅μ¬ μ¬μ μ΄ 2026λ μ°κ° μμ¬ νκΈ νλ¦ μ(+)μ κΈ°λ‘ν κ²μΌλ‘ κΈ°λνλ©°, 2027λ λ§κΉμ§ μ μ¬μ μΈ νκΈ νλ¦ μμ΅λΆκΈ°μ λ¬μ±μ μν΄ κ³μν΄μ λ Έλ ₯νκ³ μμ΅λλ€. AmirAliκ° μΈκΈνλ―μ΄, μ ν¬λ 12μμ MetaSightλ₯Ό 5,900λ§ λ¬λ¬μ μ μ§κΈ νκΈκ³Ό ν₯ν μμ μ λ° κ·μ μ μ΄μ νμ μ°κ³λ μ΅λ 9,000λ§ λ¬λ¬μ μ‘°κ±΄λΆ λκ°λ‘ μΈμνμ΅λλ€. μ ν¬λ μ΄ κΈ°μ μ΄ κΈ°μ‘΄ μ ν ν¬νΈν΄λ¦¬μ€λ₯Ό κ°ννκ³ λ€μ€ μ§λ³ νμ§ νμ΄νλΌμΈμ κ°μνν κ²μ΄λΌκ³ λ―Ώμ΅λλ€. |
| Following the MetaSight acquisition and our November equity and convertible debt financing, we ended the year with approximately $1.3 billion in cash, providing sufficient runway to fund our growth initiatives and reach company-wide cash flow breakeven. Turning to Slide 23. We entered 2026 with solid momentum across the business and increasing visibility into our growth drivers. For full year 2026, we expect revenue to be in the range of $1.25 billion to $1.28 billion, representing growth of 27% to 30%. This outlook reflects sustained strength in oncology and accelerating expansion in screening, firmly positioning us to achieve our 2028 long-range revenue target of $2.2 billion. | MetaSight μΈμμ 11μμ μ§νλ μ£Όμ λ° μ νμ¬μ± λ°νμ ν΅ν΄, μ ν¬λ μ½ 13μ΅ λ¬λ¬μ νκΈμΌλ‘ μ°λ§μ λ§κ°νμ΅λλ€. μ΄λ μ ν¬μ μ±μ₯ μ΄λμ
ν°λΈμ μκΈμ μ§μνκ³ μ μ¬μ μΈ νκΈ νλ¦ μμ΅λΆκΈ°μ μ λλ¬νκΈ°μ μΆ©λΆν μκΈ μ¬λ ₯μ μ 곡ν©λλ€. μ¬λΌμ΄λ 23λ²μΌλ‘ λμ΄κ°κ² μ΅λλ€. μ ν¬λ 2026λ μ μμνλ©° μ¬μ μ λ°μ κ±Έμ³ κ²¬κ³ ν λͺ¨λ©ν μ ν보νμΌλ©°, μ±μ₯ λλ ₯μ λν κ°μμ±μ΄ λμμ§κ³ μμ΅λλ€. 2026λ μ°κ° κΈ°μ€μΌλ‘ λ§€μΆμ 12μ΅ 5μ²λ§ λ¬λ¬μμ 12μ΅ 8μ²λ§ λ¬λ¬ μ¬μ΄κ° λ κ²μΌλ‘ μμνλ©°, μ΄λ 27%μμ 30%μ μ±μ₯μ μλ―Έν©λλ€. μ΄λ¬ν μ λ§μ μ’ μν λΆμΌμμμ μ§μμ μΈ κ°μΈμ μ€ν¬λ¦¬λ λΆμΌμμμ κ°μνλλ νμ₯μ λ°μνλ©°, μ΄λ μ ν¬κ° 2028λ μ₯κΈ° λ§€μΆ λͺ©νμΈ 22μ΅ λ¬λ¬λ₯Ό λ¬μ±ν μ μλλ‘ νκ³ ν μ리맀κΉνκ² ν©λλ€. |
| We expect oncology revenue growth of 25% to 27% in 2026, supported by volume growth of approximately 30%. We believe demand fundamentals remain strong across the portfolio. Guardant360 Liquid should continue to benefit from adoption of Smart apps and Guardant360 tissue growth should continue to build on the Smart Platform upgrade and continued strong commercial execution. Reveal is expected to remain our fastest-growing oncology product, driven by MRD and therapy monitoring. Note that our oncology guidance does not include potential upsides during the year from SERENA-6 ESR1 monitoring, FDA approval of Guardant360 Liquid CDx and the launch of Reveal Ultra. | μ ν¬λ 2026λ μ μ’ μν λ§€μΆμ΄ μ½ 30%μ λ¬Όλ μ±μ₯μ νμ μ΄ 25%μμ 27% μ±μ₯ν κ²μΌλ‘ μμν©λλ€. ν¬νΈν΄λ¦¬μ€ μ λ°μ κ±Έμ³ μμ νλλ©νΈμ΄ κ²¬κ³ νκ² μ μ§λκ³ μλ€κ³ λ―Ώμ΅λλ€. Guardant360 Liquidλ Smart μ± μ±νμ νμ μ΄ μ§μμ μΌλ‘ μ±μ₯ν κ²μΌλ‘ 보μ΄λ©°, Guardant360 tissueμ μ±μ₯μ Smart νλ«νΌ μ κ·Έλ μ΄λμ μ§μμ μΈ κ°λ ₯ν μμ λ ₯μ κΈ°λ°νμ¬ κ³μν΄μ μ±μ₯ν κ²μ λλ€. Revealμ MRD λ° μΉλ£ λͺ¨λν°λ§μ νμ μ΄ λΉμ¬μ κ°μ₯ λΉ λ₯΄κ² μ±μ₯νλ μ’ μν μ νμΌλ‘ λ¨μ κ²μΌλ‘ μμλ©λλ€. μ°Έκ³ λ‘, λΉμ¬μ μ’ μν κ°μ΄λμ€μλ SERENA-6 ESR1 λͺ¨λν°λ§, Guardant360 Liquid CDxμ FDA μΉμΈ, κ·Έλ¦¬κ³ Reveal Ultra μΆμλ‘ μΈν μ¬ν΄ μ°μ€ μ μ¬μ μμΉ μ¬λ ₯μ ν¬ν¨λμ΄ μμ§ μμ΅λλ€. |
| For biopharma and data, we're encouraged by recent strategic partnerships and the strength of our CDx pipeline. For 2026, we're forecasting low double-digit revenue growth, supported by both ongoing collaborations and new program starts. We expect screening revenue to be in the range of $162 million to $174 million, driven by 210,000 to 225,000 tests, a meaningful growth from approximately $80 million revenue and 87,000 tests in 2025. As in 2025, we expect sequential increase in Shield volumes every quarter with the increases expected to be greater towards the back half of the year. | μλͺ 곡ν λ° λ°μ΄ν° λΆλ¬Έμμλ μ΅κ·Όμ μ λ΅μ ννΈλμκ³Ό λΉμ¬ CDx(λλ°μ§λ¨) νμ΄νλΌμΈμ κ°μ μ κ³ λ¬΄λμ΄ μμ΅λλ€. 2026λ μλ νμ¬ μ§ν μ€μΈ νλ ₯ κ΄κ³μ μλ‘μ΄ νλ‘κ·Έλ¨ μμμ νμ μ΄ λ μλ¦Ώμ μ΄λ°λμ λ§€μΆ μ±μ₯μ μ λ§νκ³ μμ΅λλ€. μ€ν¬λ¦¬λ λ§€μΆμ 21λ§ κ±΄μμ 22λ§ 5μ² κ±΄μ κ²μ¬λμ νμ μ΄ 1μ΅ 6,200λ§ λ¬λ¬μμ 1μ΅ 7,400λ§ λ¬λ¬ μ¬μ΄κ° λ κ²μΌλ‘ μμν©λλ€. μ΄λ 2025λ μ μ½ 8μ²λ§ λ¬λ¬ λ§€μΆκ³Ό 8λ§ 7μ² κ±΄μ κ²μ¬λμμ ν¬κ² μ±μ₯ν μμΉμ λλ€. 2025λ κ³Ό λ§μ°¬κ°μ§λ‘, λ§€ λΆκΈ° Shield κ²μ¬λμ μμ°¨μ μ¦κ°λ₯Ό μμνλ©°, νΉν νλ°κΈ°μ μ¦κ°νμ΄ λ μ»€μ§ κ²μΌλ‘ 보μ λλ€. |
| This reflects early year seasonality at PCP offices, the ramping productivity of our growing number of sales reps and the expansion of EMR capability through our Quest and PathGroup collaborations. Note that our screening guidance does not include potential upside from Quest co-promotion activities as well as ACS guideline inclusion, which we continue to expect in the near future. We continue to make steady progress improving gross margins across our products through ASP optimization, workflow efficiencies, transition to NovaSeq X and disciplined cost management. | μ΄λ PCP μ¬λ¬΄μ€μμ λνλλ μ°μ΄ κ³μ μ μμΈ, μ¦κ°νλ μμ μ¬μλ€μ μμ°μ± ν₯μ, κ·Έλ¦¬κ³ Quest λ° PathGroupκ³Όμ νλ ₯μ ν΅ν EMR κΈ°λ₯ νμ₯μ λ°μν©λλ€. μ°Έκ³ λ‘, λΉμ¬μ μ€ν¬λ¦¬λ κ°μ΄λμ€μλ Quest 곡λ νλ‘λͺ¨μ νλ λ° ACS κ°μ΄λλΌμΈ ν¬ν¨μΌλ‘ μΈν μ μ¬μ μμΉ μ¬λ ₯μ ν¬ν¨λμ΄ μμ§ μμΌλ©°, μ΄ λ κ°μ§ λͺ¨λ κ°κΉμ΄ λ―Έλμ μ€νλ κ²μΌλ‘ μ§μμ μΌλ‘ κΈ°λνκ³ μμ΅λλ€. μ ν¬λ ASP μ΅μ ν, μν¬νλ‘μ° ν¨μ¨μ± μ¦λ, NovaSeq Xλ‘μ μ ν, κ·Έλ¦¬κ³ μ격ν λΉμ© κ΄λ¦¬λ₯Ό ν΅ν΄ λͺ¨λ μ νμ λ§€μΆ μ΄μ΄μ΅μ κ°μ νλ λ° κΎΈμ€ν μ§μ μ μ΄λ£¨κ³ μμ΅λλ€. |
| For 2026, we expect non-GAAP gross margin to be in the range of 64% to 65%, reflecting ongoing operational improvements, volume growth and expected product mix. We expect non-GAAP operating expenses of $1.03 billion to $1.05 billion, representing 14% to 16% growth year-over-year. We anticipate continued operating leverage as revenue growth outpaces expense growth. R&D and G&A are expected again to remain relatively stable with incremental investment primarily directed towards screening sales and marketing. Finally, we remain focused on reducing cash burn each year. For 2026, we expect free cash flow burn of $185 million to $195 million, an improvement from 2025. | 2026λ μ κ²½μ°, μ§μμ μΈ μ΄μ κ°μ , λ¬Όλ μ¦κ° λ° μμλλ μ ν λ―Ήμ€λ₯Ό λ°μνμ¬ λΉGAAP λ§€μΆμ΄μ΄μ΅λ₯ μ 64%μμ 65% λ²μκ° λ κ²μΌλ‘ μμν©λλ€. λΉGAAP μμ λΉμ©μ 10μ΅ 3μ²λ§ λ¬λ¬μμ 10μ΅ 5μ²λ§ λ¬λ¬κ° λ κ²μΌλ‘ μμνλ©°, μ΄λ μ λ λλΉ 14%μμ 16%μ μ±μ₯μ λνλ λλ€. λ§€μΆ μ±μ₯μ΄ λΉμ© μ±μ₯μ μμ§λ₯΄λ©΄μ μ§μμ μΈ μμ λ λ²λ¦¬μ§λ₯Ό κΈ°λνκ³ μμ΅λλ€. μ°κ΅¬ κ°λ°(R&D) λ° νλ§€λΉμκ΄λ¦¬λΉ(G&A)λ λ€μ μλμ μΌλ‘ μμ μ μΌλ‘ μ μ§λ κ²μΌλ‘ μμλλ©°, μΆκ° ν¬μλ μ£Όλ‘ μ€ν¬λ¦¬λ(screening) μμ λ° λ§μΌν μ μ§μ€λ κ²μ λλ€. λ§μ§λ§μΌλ‘, μ ν¬λ λ§€λ νκΈ μμ§(cash burn)μ μ€μ΄λ λ° κ³μ μ§μ€νκ³ μμ΅λλ€. 2026λ μλ μμ¬ νκΈ νλ¦ μμ§(free cash flow burn)μ΄ 1μ΅ 8μ² 5λ°±λ§ λ¬λ¬μμ 1μ΅ 9μ² 5λ°±λ§ λ¬λ¬κ° λ κ²μΌλ‘ μμνλ©°, μ΄λ 2025λ λλΉ κ°μ λ μμΉμ λλ€. |
| Excluding screening, we expect the remainder of the business to be free cash flow positive for the full year. Finally, turning to Slide 24. Looking ahead, we have a rich set of catalysts across our business that will drive continued growth. In oncology, we expect to launch several new products, including Guardant360 Liquid CDx following FDA approval, our ESR 1 monitoring test and Reveal Ultra. In addition, we expect to release additional apps driven by our Smart Platform and advanced reimbursement across multiple indications for Reveal. In biopharma and data, we expect new CDx approvals as well as additional strategic biopharma and Infinity AI data partnerships. | μ€ν¬λ¦¬λ λΆλ¬Έμ μ μΈν λλ¨Έμ§ μ¬μ
λΆλ¬Έμ μ°κ° κΈ°μ€μΌλ‘ μμ¬νκΈνλ¦ νμλ₯Ό κΈ°λ‘ν κ²μΌλ‘ μμν©λλ€. λ§μ§λ§μΌλ‘, 24νμ΄μ§λ₯Ό 보μκ² μ΅λλ€. ν₯ν μ λ§μ λ§μλ리면, μ ν¬λ μ¬μ μ λ°μ κ±Έμ³ μ§μμ μΈ μ±μ₯μ 견μΈν νλΆν μ±μ₯ λλ ₯(catalysts)μ κ°μ§κ³ μμ΅λλ€. μ’ μν λΆμΌμμλ FDA μΉμΈ μ΄ν Guardant360 Liquid CDx, μ ν¬μ ESR 1 λͺ¨λν°λ§ ν μ€νΈ, κ·Έλ¦¬κ³ Reveal Ultraλ₯Ό ν¬ν¨ν μ¬λ¬ μ μ νμ μΆμν μμ μ λλ€. λν, μ ν¬ Smart Platformμ κΈ°λ°μΌλ‘ ν μΆκ° μ±μ μΆμνκ³ , Revealμ λν μ¬λ¬ μ μμ¦μ κ±Έμ³ μν λ²μκ° νλλ κ²μΌλ‘ κΈ°λν©λλ€. λ°μ΄μ€ μ μ½ λ° λ°μ΄ν° λΆμΌμμλ μλ‘μ΄ CDx μΉμΈλΏλ§ μλλΌ, μΆκ°μ μΈ μ λ΅μ λ°μ΄μ€ μ μ½ λ° Infinity AI λ°μ΄ν° ννΈλμμ κΈ°λνκ³ μμ΅λλ€. |
| In screening, we look forward to inclusion in ACS guidelines in the near future, driving commercial expansion with Quest and expanding self-pay Shield outside the U.S. With that, we'll now open the call for questions. | μ λ³ κ²μ¬ λΆμΌμμλ κ°κΉμ΄ μμΌ λ΄μ ACS κ°μ΄λλΌμΈμ λ±μ¬λκ³ , Questμμ μμ
μ νμ₯μ μΆμ§νλ©°, λ―Έκ΅ μΈ μ§μμΌλ‘ μλΉ λΆλ΄ Shieldλ₯Ό νλν κ²μ κΈ°λνκ³ μμ΅λλ€. μ΄κ²μΌλ‘, μ΄μ μ§μμλ΅ μκ°μ κ°κ² μ΅λλ€. |
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* Guardant Healthλ 2025λ
4λΆκΈ° λ§€μΆ 2μ΅ 8,100λ§ λ¬λ¬(YoY +39%) λ° μ°κ° λ§€μΆ 9μ΅ 8,200λ§ λ¬λ¬(YoY +33%)λ₯Ό κΈ°λ‘νλ©° κ°λ ₯ν μ±μ₯μ 보μμΌλ©°, 2026λ
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| Original | Translation |
|---|---|
| Operator: [Operator Instructions] The first question comes from the line of Dan Leonard with UBS. | **Operator:** 첫 λ²μ§Έ μ§λ¬Έμ UBSμ Dan Leonardλκ»μ ν΄μ£Όμ ¨μ΅λλ€. |
| Daniel Leonard: UBS Investment Bank, Research Division I'd like to talk a little bit about Reveal therapeutic monitoring. Helmy, both you and Mike commented on that in your prepared remarks. Could you elaborate further on how you're framing that opportunity, both for Reveal volumes as well as for Guardant360 volumes as well. | **Daniel Leonard:** Reveal μΉλ£ λͺ¨λν°λ§(therapeutic monitoring)μ λν΄ μ’ λ μμΈν μ¬μ€λ³΄κ³ μΆμ΅λλ€. ν¬λ―Έλκ³Ό λ§μ΄ν¬λ λ λΆ λͺ¨λ λͺ¨λ λ°μΈ(prepared remarks)μμ μ΄ μ μ λν΄ μΈκΈνμ ¨λλ°μ. Reveal κ²μ¬λ(volumes)κ³Ό Guardant360 κ²μ¬λ λͺ¨λμ μμ΄μ, μ΄ κΈ°νλ₯Ό μ΄λ»κ² λ³΄κ³ κ³μ μ§ μ’ λ μμΈν μ€λͺ ν΄ μ£Όμ€ μ μμΌμ€κΉμ? |
| Helmy Eltoukhy: Co-Founder, Co-CEO & Chairman Yes. We're very excited about Reveal for therapy monitoring. We think it's an important opportunity to really solidify and work synergistically with Guardant360. If you think about it, all the volume we have with 360 patients are being tested in terms of therapy selection. And then this idea of coupling that with Reveal for essentially monitoring how those patients are doing on therapy is really exciting. And then the nice thing about that is, unfortunately, as some of those patients progress, they're going to need a new therapeutic decision in terms of hopefully a next-generation drug or a next-line therapy that can be applied to them. And so Reveal for therapy monitoring really bridges to that next Guardant360 test. And we have a very unique platform and portfolio that allows these tests to work together. And so I would say that when we get some of the reimbursement wins for IO monitoring and chemo monitoring, this could be a very important driver for growth over the next few years for the oncology business. | **Helmy Eltoukhy:** λ€, μΉλ£ λͺ¨λν°λ§(therapy monitoring)μ μν 리λΉ(Reveal)μ λν΄ λ§€μ° κ³ λ¬΄μ μ λλ€. μ΄λ κ°λνΈ360(Guardant360)κ³Ό μλμ§λ₯Ό λ΄κ³ κ·Έ μ μ§λ₯Ό νκ³ ν λ€μ§λ λ° λ§€μ° μ€μν κΈ°νλΌκ³ μκ°ν©λλ€. μκ°ν΄λ³΄μλ©΄, κ°λνΈ360 νμκ΅°μμ λ°μνλ λͺ¨λ λ³Όλ₯¨(volume)μ μΉλ£μ μ ν(therapy selection)μ μν΄ κ²μ¬λκ³ μμ΅λλ€. κ·Έλ¦¬κ³ μ΄λ¬ν κ²μ¬λ₯Ό 리λΉκ³Ό μ°κ³νμ¬ νμλ€μ΄ μΉλ£μ μ΄λ»κ² λ°μνλμ§ λͺ¨λν°λ§νλ κ²μ μ λ§ κ³ λ¬΄μ μΈ μΌμ λλ€. μ΄ μ μ κΈμ μ μΈ μΈ‘λ©΄μ, μνκΉκ²λ μΌλΆ νμλ€μ μ§λ³μ΄ μ§νλ¨μ λ°λΌ, λ°λΌκ±΄λ μ°¨μΈλ μ½λ¬Ό(next-generation drug)μ΄λ λ€μ λ¨κ³ μΉλ£λ²(next-line therapy)κ³Ό κ°μ μλ‘μ΄ μΉλ£ κ²°μ μ΄ νμνκ² λ κ²μ΄λΌλ μ μ λλ€. λ°λΌμ μΉλ£ λͺ¨λν°λ§μ μν 리λΉμ λ€μ κ°λνΈ360 κ²μ¬λ‘ μμ°μ€λ½κ² μ°κ²°λ©λλ€. μ ν¬λ μ΄λ¬ν κ²μ¬λ€μ΄ μλ‘ μλμ§λ₯Ό λΌ μ μλλ‘ νλ λ§€μ° λ νΉν νλ«νΌκ³Ό ν¬νΈν΄λ¦¬μ€λ₯Ό 보μ νκ³ μμ΅λλ€. λ°λΌμ, λ©΄μνμμ (IO) λͺ¨λν°λ§κ³Ό νμννμλ² λͺ¨λν°λ§μ λν 보ν κΈμ¬ μΈμ (reimbursement)μ λ°κ² λλ€λ©΄, μ΄λ ν₯ν λͺ λ κ° μ ν¬ μ’ μν μ¬μ μ λ§€μ° μ€μν μ±μ₯ λλ ₯μ΄ λ μ μλ€κ³ λ§μλ릴 μ μκ² μ΅λλ€. |
| Operator: The next question comes from the line of Puneet Souda with Leerink Partners. | **Operator:** λ€μ μ§λ¬Έμ Leerink Partnersμ Puneet Soudaλκ»μ ν΄μ£Όμκ² μ΅λλ€. |
| Puneet Souda: Leerink Partners LLC, Research Division The first one, Helmy, for you. When you look at the strong growth that you've seen in oncology, maybe could you elaborate how should we think about that throughout the year and both in G360 versus Reveal? How should we think about the growth of those products? Because important drivers like the camizestrant launch and other things that you mentioned are actually still not in the guide. So just trying to think about sort of how should we think about both of these products volume growth throughout the year. | **Puneet Souda:** νμμ (oncology) λΆλ¬Έμμ λνλ κ°λ ₯ν μ±μ₯μ κ³ λ €ν λ, μ¬ν΄ λ΄λ΄ κ·Έ μΆμΈκ° μ΄λ»κ² μ΄μ΄μ§μ§, νΉν G360κ³Ό Reveal λ μ νμ μ±μ₯μ μ΄λ»κ² μ λ§ν΄μΌ ν μ§ μ’ λ μμΈν μ€λͺ ν΄ μ£Όμκ² μ΅λκΉ? μΉ΄λ―Έμ μ€νΈλνΈ(camizestrant) μΆμμ κ°μ μ€μν μ±μ₯ λλ ₯(growth drivers)κ³Ό μΈκΈνμ λ€λ₯Έ μμΈλ€μ΄ μμ§ κ°μ΄λμ€(guidance)μ λ°μλμ§ μμ μν©μ΄λΌ, μ¬ν΄ μ΄ λ μ νμ νλ§€λ(volume) μ±μ₯μ μ΄λ»κ² μμν΄μΌ ν μ§ κΆκΈν©λλ€. |
| Helmy Eltoukhy: Co-Founder, Co-CEO & Chairman Yes. Maybe I'll start and I'll let Mike sort of jump in. We're very bullish about '26 in terms of the progress we've made in '25 and what we're seeing at the beginning of the year here. So I would say that we think it's going to be another strong year for 360, something around at least 20% growth in terms of volumes. And then obviously, another very strong year for Reveal. It will continue to be our fastest-growing product. We think we'll see some acceleration, obviously, with Reveal for therapy monitoring as well on top of that. So I think we're well underway for sort of LRP Investor Day projections in 2028. | **Helmy Eltoukhy:** λ€, μ κ° λ¨Όμ λ§μλλ¦¬κ³ , λ§μ΄ν¬κ° μ΄μ΄μ 보좩 μ€λͺ
ν΄ μ£Όλλ‘ νκ² μ΅λλ€. μ ν¬λ 2025λ μ μ΄λ£¬ μ§μ κ³Ό μ¬ν΄ μ΄μ 보μ΄κ³ μλ μΆμΈλ₯Ό κ°μν λ, 2026λ μ λν΄ λ§€μ° λκ΄μ μ λλ€. λ°λΌμ 360 μ νκ΅°μκ²λ λ ν λ²μ κ°λ ₯ν ν ν΄κ° λ κ²μ΄λΌκ³ μκ°νλ©°, μ΅μ 20% μ΄μμ νλ§€λ(volumes) μ±μ₯μ μμνκ³ μμ΅λλ€. κ·Έλ¦¬κ³ λ¬Όλ‘ , Revealμκ²λ λ§€μ° κ°λ ₯ν ν ν΄κ° λ κ²μ λλ€. Revealμ κ³μν΄μ μ ν¬μ κ°μ₯ λΉ λ₯΄κ² μ±μ₯νλ μ νμ΄ λ κ²μ λλ€. κ·ΈλΏλ§ μλλΌ, μΉλ£ λͺ¨λν°λ§(therapy monitoring)μ μν Reveal μ νμμλ λΆλͺ ν κ°μνκ° λνλ κ²μΌλ‘ μμν©λλ€. λ°λΌμ 2028λ μ₯κΈ° κ³ν(LRP: Long-Range Plan) ν¬μμμ λ (Investor Day) μ λ§μΉ λ¬μ±μ ν₯ν΄ μμ‘°λ‘κ² λμκ°κ³ μλ€κ³ μκ°ν©λλ€. |
| Chief Financial Officer: Yes. Well, maybe just to add because we didn't talk about tissue. I think in the back half of '25, we saw a nice acceleration with Guardant360 tissue following the smart upgrades that we did back in May of last year. And so I think that also as we look forward in 2026, we continue to expect tissue to accelerate. We think there's getting the FDA approval for Guardant360 during the year also could potentially have a pull-through impact on Guardant360 tissue as well. So yes, we're feeling bullish about all of the products across oncology. | **Chief Financial Officer:** λ€, μ, μ‘°μ§ κ²μ¬(tissue biopsy)μ λν΄μλ μΈκΈνμ§ μμκΈ° λλ¬Έμ λ§λΆμ¬ λ§μλ리μλ©΄, μ ν¬λ 2025λ νλ°κΈ°μλ Guardant360 μ‘°μ§ κ²μ¬μμ μλΉν κ°μν(acceleration)λ₯Ό 보μμ΅λλ€. μ΄λ μλ 5μμ λ¨ννλ μ€λ§νΈ μ κ·Έλ μ΄λ(smart upgrades) μ΄νμ κ²°κ³Όμ λλ€. κ·Έλ¦¬κ³ μ ν¬λ λν 2026λ μ λ΄λ€λ³Ό λ, μ‘°μ§ κ²μ¬κ° κ³μν΄μ κ°μνλ κ²μΌλ‘ μμνκ³ μμ΅λλ€. μ¬ν΄ Guardant360μ λν FDA μΉμΈ(approval)μ λ°λ κ²μ΄ Guardant360 μ‘°μ§ κ²μ¬μλ μ°μμ μΈ κΈμ μ μν₯(pull-through impact)μ λ―ΈμΉ μ μλ€κ³ μκ°ν©λλ€. κ·Έλμ λ€, μ ν¬λ μ’ μν(oncology) λΆμΌμ λͺ¨λ μ νμ λν΄ λκ΄μ (bullish)μΌλ‘ λ³΄κ³ μμ΅λλ€. |
| Operator: The next question comes from the line of Doug Schenkel with Wolfe Research. | **Operator:** λ€μ μ§λ¬Έμ μΈν 리μμΉ(Wolfe Research)μ λκ·Έ μ₯ν΄λκ»μ ν΄μ£Όμκ² μ΅λλ€. |
| Wolfe Research, LLC: Both on Shield and they're related. It's really great to hear that you are expecting to be free cash flow positive in 2026, excluding Shield. I'm curious what you're thinking in terms of Shield specific burn. I think you've provided color on that in the past. And I guess kind of building off of that, I believe you exited 2025 with approximately 300 Shield-focused reps. How should we be thinking about the pacing of rep hiring throughout 2026? And where do you think the sales force should be at year-end? | **Wolfe Research, LLC:** μ΄λ(Shield) κ΄λ ¨ μ§λ¬Έμ΄μκ΅°μ. μ΄λλ₯Ό μ μΈνκ³ 2026λ
μ μμ¬νκΈνλ¦(free cash flow) νμλ₯Ό μμνμ λ€λ λ§€μ° κ³ λ¬΄μ μ
λλ€. μ΄λ λΆλ¬Έμ ꡬ체μ μΈ νκΈ μμ§(cash burn)μ λν΄μλ μ΄λ»κ² μκ°νμλμ§ κΆκΈν©λλ€. κ³Όκ±°μλ κ΄λ ¨ λ΄μ©μ μ€λͺ
ν΄μ£Όμ λ° μμ΅λλ€λ§, λ€μ νλ² λ§μν΄μ£Όμλ©΄ κ°μ¬νκ² μ΅λλ€. μ΄μ μ°κ΄νμ¬, 2025λ λ§ κΈ°μ€μΌλ‘ μ½ 300λͺ μ μ΄λ μ λ΄ μμ μ¬μμ 보μ νκ³ κ³μ ¨λ κ²μΌλ‘ νμ νκ³ μμ΅λλ€. 2026λ ν ν΄ λμ μμ μ¬μ μ±μ© μλλ₯Ό μ΄λ»κ² κ°μ Έκ° κ³νμ΄μ μ§, κ·Έλ¦¬κ³ μ°λ§μλ μ 체 μμ μΈλ ₯μ΄ μ΄λ μμ€μΌλ‘ μμνμλμ§ μ¬μκ³ μΆμ΅λλ€. |
| Helmy Eltoukhy: Co-Founder, Co-CEO & Chairman Do you want to start with that? | **Helmy Eltoukhy:** κ·Έκ²λΆν° μμνμκ² μ΄μ? |
| Chief Financial Officer: Yes. Yes, I can start on the question on -- on screening burn, Doug. Yes. No, for '25, again, our overall burn for the company was $233 million. Of that, roughly around $220 million was screening. We sort of set a target of $220 million. Actually, we pushed quite hard on that, particularly towards the end of the year. We're really wanting to take advantage of our first-mover position. And we mentioned again on the call that excluding screening, the rest of the business was actually cash flow -- free cash flow positive for Q3 and Q4. For '26, we think a similar level of burn on screening as '25. So around that sort of $220 million mark. Again, we're going to be making heavy investments on the commercial side, really building out that infrastructure. And we still expect '26 to be a year of investment for screening and then '27 to be a year of inflection where we start to get a lot of operating leverage on that commercial infrastructure that we build. And maybe just to point out one other thing. Again, we set our full company free cash flow guidance of $185 million to $195 million burn. So that's implying that the rest of the business now is strongly cash flow positive in 2026. And the sort of midpoint of that guide is around $30 million positive cash flow. So yes, we're feeling really good about how we're sort of managing the burn. | **Chief Financial Officer:** λ€, μ€ν¬λ¦¬λ(screening) κ΄λ ¨ μμ§(burn) μ§λ¬Έμ λν΄ μ κ° λ¨Όμ λ§μλλ¦¬κ² μ΅λλ€. 2025λ μ κ²½μ°, μ ν¬ νμ¬μ μ 체 μμ§μ‘μ 2μ΅ 3,300λ§ λ¬λ¬μμ΅λλ€. κ·Έμ€ μ½ 2μ΅ 2,000λ§ λ¬λ¬κ° μ€ν¬λ¦¬λ λΆλ¬Έμμ λ°μνμ΅λλ€. μ ν¬λ 2μ΅ 2,000λ§ λ¬λ¬λ₯Ό λͺ©νλ‘ μ€μ νμΌλ©°, μ¬μ€ μ΄ λͺ©ν λ¬μ±μ μν΄ νΉν μ°λ§μ μλΉν λ Έλ ₯νμ΅λλ€. μ ν¬λ μ λ μ£Όμ(first-mover)λ‘μμ μμΉλ₯Ό μ κ·Ή νμ©νκ³ μ νμ΅λλ€. κ·Έλ¦¬κ³ μ ν¬λ λ€μ νλ² μ»¨νΌλ°μ€ μ½μμ μ€ν¬λ¦¬λ λΆλ¬Έμ μ μΈνλ©΄, λλ¨Έμ§ μ¬μ λΆλ¬Έμ 3λΆκΈ°μ 4λΆκΈ°μ μ€μ λ‘ νκΈ νλ¦(cash flow)μ΄, μ¦ μμ¬ νκΈ νλ¦(free cash flow)μ΄ μμ(positive)μλ€κ³ λ§μλλ Έμ΅λλ€. 2026λ μλ μ€ν¬λ¦¬λ λΆλ¬Έμ μμ§μ‘μ΄ 2025λ κ³Ό λΉμ·ν μμ€μ΄ λ κ²μΌλ‘ μμν©λλ€. μ¦, μ½ 2μ΅ 2,000λ§ λ¬λ¬ μμ€μ λλ€. λ€μ λ§μλ리μ§λ§, μ ν¬λ μμ ν(commercial) μΈ‘λ©΄μ λ§λν ν¬μλ₯Ό νμ¬ ν΄λΉ μΈνλΌλ₯Ό ꡬμΆν κ³νμ λλ€. μ ν¬λ μ¬μ ν 2026λ μ μ€ν¬λ¦¬λ(screening)μ μν ν¬μμ ν΄λ‘ λ³΄κ³ μμΌλ©°, 2027λ μ μ ν¬κ° ꡬμΆν μμ μΈνλΌ(commercial infrastructure)μμ μλΉν μμ λ λ²λ¦¬μ§(operating leverage)λ₯Ό μ»κΈ° μμνλ λ³κ³‘μ (inflection point)μ΄ λ κ²μΌλ‘ μμν©λλ€. ν κ°μ§ λ λ§μλ리μλ©΄, λ€μ λ§μλ리μ§λ§ μ ν¬λ μ μ¬μ μΈ μμ¬νκΈνλ¦(free cash flow) κ°μ΄λμ€(guidance)λ₯Ό 1μ΅ 8,500λ§ λ¬λ¬μμ 1μ΅ 9,500λ§ λ¬λ¬μ μμ§(burn)μΌλ‘ μ€μ νμ΅λλ€. μ΄λ 2026λ μ λλ¨Έμ§ μ¬μ λΆλ¬Έμ΄ κ°λ ₯νκ² νκΈνλ¦(cash flow)μ΄ κΈμ μ (positive)μ΄λΌλ κ²μ μλ―Ένλ©°, μ΄ κ°μ΄λμ€μ μ€κ°κ°μ μ½ 3μ²λ§ λ¬λ¬μ νκΈνλ¦ νμ(positive cash flow)λ₯Ό λνλ λλ€. λ°λΌμ μ ν¬λ μμ§(burn) κ΄λ¦¬μ λν΄ λ§€μ° κΈμ μ μΌλ‘ μκ°νκ³ μμ΅λλ€. |
| Co-CEO & Director: In terms of commercial infrastructure and field force, we are very excited with a very powerful commercial platform that we built in 2025. And we are going to continue to build out that commercial organization in 2026. I'm not going to get into the specifics of maybe exact headcount of the field force, but maybe just to give you some direction and color the way that we can think about it, we will continue to invest our incremental gross profit that we are going to generate this year into further build-out of our commercial infrastructure on both sales and marketing and majority would go still in building sales force and hiring more people. | **Co-CEO & Director:** μμ
μΈνλΌ(commercial infrastructure)μ νμ₯ μμ
μΈλ ₯(field force) μΈ‘λ©΄μμ λ§μλ리μλ©΄, μ ν¬λ 2025λ
μ ꡬμΆν λ§€μ° κ°λ ₯ν μμ
νλ«νΌ(commercial platform)μ λν΄ λλ¨ν κ³ λ¬΄μ μΌλ‘ μκ°νκ³ μμ΅λλ€. κ·Έλ¦¬κ³ 2026λ
μλ μ΄ μμ
μ‘°μ§(commercial organization)μ κ³μν΄μ νμ₯ν΄ λκ° κ³νμ
λλ€. νμ₯ μμ μΈλ ₯μ μ νν μΈμμ(headcount)μ λν ꡬ체μ μΈ λ΄μ©μ λ§μλλ¦¬μ§ μκ² μ΅λλ€λ§, μ ν¬κ° μ΄ μ¬μμ μ΄λ»κ² λ³΄κ³ μλμ§μ λν λ°©ν₯μ±κ³Ό λ§₯λ½μ μ’ μ€λͺ ν΄ λ리μλ©΄, μ ν¬λ μ¬ν΄ μ°½μΆν μ¦λΆ λ§€μΆμ΄μ΄μ΅(incremental gross profit)μ μμ (sales) λ° λ§μΌν (marketing) μμͺ½μ μμ μΈνλΌλ₯Ό μΆκ°μ μΌλ‘ ꡬμΆνλ λ° κ³μν΄μ ν¬μν κ²μ λλ€. κ·Έλ¦¬κ³ μ΄ ν¬μκΈμ λλΆλΆμ μ¬μ ν μμ μΈλ ₯(sales force)μ νμΆ©νκ³ λ λ§μ μΈλ ₯μ κ³ μ©νλ λ° μ¬μ©λ μμ μ λλ€. |
| Operator: The next question comes from the line of Tycho Peterson with Jefferies. | **Operator:** λ€μ μ§λ¬Έμ μ ν리μ€(Jefferies)μ νμ΄μ½ νΌν°μ¨(Tycho Peterson)λκ»μ μ§λ¬Έν΄μ£Όμκ² μ΅λλ€. |
| Tycho Peterson: Jefferies LLC, Research Division I want to start off on one of the bigger topics on ADLT pricing. What is your latest thinking? And what have you baked into the guide, if anything, for G360? And then overall, you are guiding for a decel in volumes and revenue in oncology, presumably some conservatism there. There's a lot you didn't bake in, but where do you think kind of the most conservatism is in the outlook on oncology? | **Tycho Peterson:** ADLT κ°κ²© μ±
μ (pricing)κ³Ό κ΄λ ¨ν μ£Όμ μμ λΆν° μ§λ¬Έμ μμνκ³ μΆμ΅λλ€. μ΄ λΆλΆμ λν μ΅μ 견ν΄λ μ΄λ μ κ°μ? κ·Έλ¦¬κ³ G360 κ΄λ ¨ν΄μλ νΉμ κ°μ΄λμ€(guidance)μ μ΄λ€ λΆλΆμ λ°μνμ
¨λμ§ κΆκΈν©λλ€. λ€μμΌλ‘, μ λ°μ μΌλ‘ μ’ μν(oncology) λΆλ¬Έμμ λ¬Όλ(volumes)κ³Ό λ§€μΆ(revenue)μ λν(deceleration)λ₯Ό κ°μ΄λμ€λ‘ μ μνκ³ κ³μ λ°μ, μ΄ λΆλΆμλ μ΄λ μ λ 보μμ μΈ(conservative) κ΄μ μ΄ λ°μλ κ²μΌλ‘ 보μ λλ€. μμ§ λ°μνμ§ μμΌμ λΆλΆμ΄ λ§μ κ² κ°μλ°, μ’ μν λΆλ¬Έ μ λ§(outlook)μμ κ°μ₯ 보μμ μΌλ‘ 보μλ λΆλΆμ΄ μ΄λλΌκ³ μκ°νμλμ§ λ§μν΄μ£Όμ€ μ μμκΉμ? |
| Helmy Eltoukhy: Co-Founder, Co-CEO & Chairman Yes. In terms of ADLT, I think we're still on track in terms of FDA submission, making very good progress there. We think that hopefully gets through the finish line in the second half of this year and then potentially sets up second sort of next ADLT pricing rate for 360 at the beginning of '27. So nothing is baked in, in terms of ADLT pricing for 360 for 2026. In terms of the second part of your question, I'll let... | **Helmy Eltoukhy:** λ€, ADLT(Advanced Diagnostic Laboratory Test)μ κ΄λ ¨ν΄μλ FDA μ μΆμ΄ μ¬μ ν μμ‘°λ‘κ² μ§νλκ³ μμΌλ©°, μμ£Ό μ’μ μ§μ μ 보μ΄κ³ μλ€κ³ μκ°ν©λλ€. μ¬ν΄ νλ°κΈ°μλ λ§λ¬΄λ¦¬λ μ μκΈ°λ₯Ό λ°λΌλ©°, μ μ¬μ μΌλ‘λ 2027λ
μ΄μ 360μ λν λ€μ ADLT κ°κ²© μ±
μ λ₯ μ μ€μ ν μ μμ κ²μΌλ‘ λ³΄κ³ μμ΅λλ€. λ°λΌμ 2026λ
360μ λν ADLT κ°κ²© μ±
μ κ³Ό κ΄λ ¨ν΄μλ μμ§ νμ λ κ²μ΄ μμ΅λλ€. μ§λ¬Έμ λ λ²μ§Έ λΆλΆμ λν΄μλ, λ€λ₯Έ λΆκ» λκΈ°κ² μ΅λλ€. |
| Chief Financial Officer: Yes. I mean maybe on the volumes, '25 was an incredibly strong year, particularly with Guardant360 and just with the Smart apps driving the volume. But I think we look at 2026 as just continuing that trend. Our guide is 30% oncology volume growth. And so we think that's incredibly strong. And again, that's coming across all of the portfolio. Helmy mentioned it earlier, but we still expect strong traction with Guardant360, Reveal being the fastest-growing product and tissue continuing to accelerate. So yes, I think we're feeling really positive about the guide that we put out for oncology growth next year -- or this year, should... | **Chief Financial Officer:** λ€. νλ§€λ(volume) μΈ‘λ©΄μμ 보면, 2025λ
μ Guardant360κ³Ό Smart μ±λ€μ΄ νλ§€λμ 견μΈνλ©΄μ μ λ§ κ°λ ₯ν ν ν΄μμ΅λλ€. νμ§λ§ μ ν¬λ 2026λ
μλ μ΄λ¬ν μΆμΈκ° κ³μ μ΄μ΄μ§ κ²μΌλ‘ λ³΄κ³ μμ΅λλ€. μ ν¬κ° μ μν κ°μ΄λμ€(guidance)λ μ’ μν λΆμΌ νλ§€λ 30% μ±μ₯μ λλ€. μ΄λ κ΅μ₯ν κ°λ ₯ν μμΉλΌκ³ μκ°ν©λλ€. κ·Έλ¦¬κ³ λ€μ λ§μλ리μ§λ§, μ΄λ μ ν¬ μ 체 ν¬νΈν΄λ¦¬μ€(portfolio) μ λ°μ κ±Έμ³ λνλλ νμμ λλ€. ν¬λ―Έκ° μμ μΈκΈνλ―μ΄, Guardant360μ μ¬μ ν κ°λ ₯ν 견μΈλ ₯μ λ³΄μΌ κ²μΌλ‘ μμνλ©°, Revealμ κ°μ₯ λΉ λ₯΄κ² μ±μ₯νλ μ νμ΄ λ κ²μ΄κ³ , μ‘°μ§ κ²μ¬(tissue test) μμ κ³μν΄μ κ°μνλ κ²μ λλ€. κ·Έλμ λ€, μ ν¬λ λ΄λ λ... μλ, μ¬ν΄μ μ’ μν λΆμΌ μ±μ₯μ λν΄ μ ν¬κ° μ μν κ°μ΄λμ€μ λν΄ λ§€μ° κΈμ μ μΌλ‘ μκ°νκ³ μμ΅λλ€. |
| Tycho Peterson: Jefferies LLC, Research Division Okay, Mike. And then just a follow-up on speak of conservatism, you're also guiding for Shield ASPs to be down relative to where you exited '25. What's the thought process there? And also, what are you baking in for international? I know you flagged that as incremental. | **Tycho Peterson:** 보μμ μΈ κ΄μ μμ μΆκ° μ§λ¬Έμ΄ μμ΅λλ€. 2025λ λ§ λλΉ Shield ASP(νκ· νλ§€ λ¨κ°)κ° νλ½ν κ²μΌλ‘ κ°μ΄λμ€λ₯Ό μ μνμ ¨λλ°μ, μ΄λ€ νλ¨μμ κ·Έλ¬μ 건κ°μ? κ·Έλ¦¬κ³ ν΄μΈ μμ₯μ λν΄μλ μ΄λ€ λΆλΆμ λ°μνκ³ κ³μ κ°μ? μ μ§μ μΈ μ±μ₯ μμΈμΌλ‘ μΈκΈνμ κ²μΌλ‘ μκ³ μμ΅λλ€. |
| Chief Financial Officer: Yes. On Shield ASP, we've seen this trend over the past few quarters. We've really focused on the Medicare population and reimbursable tests. And I think we've done a really great job there. But there is -- we are seeing a lot of demand from the under 65. And so I think our assumption going into '26 is that, that demand will continue to grow and that sort of mix of commercial versus Medicare is just going to increase. So that's really the fundamentals of how we see the ASP moving. we still will maintain the ADLT rate at $14.95. That's now going to be in place for '26 and '27. And we're seeing great reimbursement from Medicare Advantage payers saying that's been leading to some out-of-period true-ups as well. And our ASP for Medicare Advantage is getting stronger and stronger. But yes, it's just really going to be -- it's a mix impact between Medicare and non-Medicare. And on the international side, if the question was focused on Shield, we've seen small contribution from Abu Dhabi in '25. I think we expect, again, the international contribution to be relatively small in '26 and really the driver of the vast majority of the volume and the volume growth is going to come from the U.S. in '26. | **Chief Financial Officer:** λ€, Shield ASP (νκ· νλ§€ κ°κ²©)μ κ΄λ ¨ν΄μλ μ§λ λͺ λΆκΈ° λμ μ΄λ¬ν μΆμΈλ₯Ό 보μμ΅λλ€. μ ν¬λ λ©λμΌμ΄ (Medicare) λμ μΈκ΅¬μ 보ν μ μ©μ΄ κ°λ₯ν κ²μ¬μ μ λ§ μ§μ€ν΄ μμ΅λλ€. κ·Έλ¦¬κ³ κ·Έ λΆλΆμμ λ§€μ° νλ₯ν μ±κ³Όλ₯Ό κ±°λμλ€κ³ μκ°ν©λλ€. νμ§λ§ 65μΈ λ―Έλ§ μΈκ΅¬λ‘λΆν°λ λ§μ μμλ₯Ό λ³΄κ³ μμ΅λλ€. λ°λΌμ 2026λ μΌλ‘ κ°μλ‘ μ΄λ¬ν μμλ κ³μ μ¦κ°ν κ²μ΄λ©°, μμ 보ν (Commercial)κ³Ό λ©λμΌμ΄μ λΉμ€ (mix) λν λμ΄λ κ²μ΄λΌκ³ κ°μ νκ³ μμ΅λλ€. μ΄κ²μ΄ λ°λ‘ μ ν¬κ° ASPμ μμ§μμ 보λ κΈ°λ³Έμ μΈ κ΄μ μ λλ€. μ ν¬λ ADLT (Advanced Diagnostic Laboratory Test) μμ¨μ 14.95λ¬λ¬λ‘ κ³μ μ μ§ν κ²μ λλ€. μ΄ μμ¨μ μ΄μ 2026λ κ³Ό 2027λ μλ μ μ©λ μμ μ λλ€. κ·Έλ¦¬κ³ λ©λμΌμ΄ μ΄λλ°΄ν°μ§ (Medicare Advantage) μ§λΆμλ€λ‘λΆν°λ νλ₯ν μν (reimbursement)μ λ°κ³ μμΌλ©°, μ΄λ μΌλΆ κΈ°κ° μΈ μ μ° (out-of-period true-ups)μΌλ‘λ μ΄μ΄μ§κ³ μμ΅λλ€. λ©λμΌμ΄ μ΄λλ°΄ν°μ§ κ΄λ ¨ ASPλ μ μ λ κ°ν΄μ§κ³ μμ΅λλ€. λ€, κ·Έλ μ΅λλ€λ§, λ©λμΌμ΄μ λΉ(ι)λ©λμΌμ΄ κ°μ 볡ν©μ μΈ μν₯μ΄ μμ κ²μΌλ‘ μμλ©λλ€. κ΅μ λΆλ¬Έκ³Ό κ΄λ ¨νμ¬ Shieldμ λν μ§λ¬Έμ΄μ ¨λ€λ©΄, 2025λ μλ μλΆλ€λΉ(Abu Dhabi)μμ μνμ κΈ°μ¬(contribution)κ° μμμ΅λλ€. μ ν¬λ 2026λ μλ κ΅μ λΆλ¬Έμ κΈ°μ¬λ μλμ μΌλ‘ μμ κ²μΌλ‘ λ€μ νλ² μμνκ³ μμ΅λλ€. κ·Έλ¦¬κ³ λ¬Όλ(volume)μ λλΆλΆκ³Ό λ¬Όλ μ¦κ°(volume growth)λ₯Ό μ΄λλ μ£Όμ λλ ₯μ 2026λ μλ λ―Έκ΅μμ λμ¬ κ²μ λλ€. |
| Operator: The next question comes from the line of Daniel Markowitz with Evercore ISI. | **Operator:** λ€μ μ§λ¬Έμ μλ²μ½μ΄ ISIμ λ€λμ λ§μ½μμΈ λκ»μ ν΄μ£Όμκ² μ΅λλ€. |
| Daniel Markowitz: Evercore ISI Institutional Equities, Research Division I wanted to ask on Reveal Ultra. It sounds like that's an area where there's a lot of excitement internally. Can you talk a bit about what will be differentiated about the offering, how you see the tumor-informed competitive landscape evolving and when we can expect to see some data or a more substantial update on that asset? | **Daniel Markowitz:** Reveal Ultraμ λν΄ μ¬μ€λ³΄κ³ μΆμ΅λλ€. λ΄λΆμ μΌλ‘ ν° κΈ°λλ₯Ό λͺ¨μΌκ³ μλ λΆμΌλ‘ λ€μμ΅λλ€. ν΄λΉ μ ν(offering)μ μ°¨λ³μ μ΄ λ¬΄μμΈμ§, μ’ μ μ 보 κΈ°λ°(tumor-informed) κ²½μ νκ²½μ΄ μ΄λ»κ² λ³νν κ²μΌλ‘ 보μλμ§, κ·Έλ¦¬κ³ ν΄λΉ μμ°(asset)μ λν λ°μ΄ν°λ λ³΄λ€ μ€μ§μ μΈ μ λ°μ΄νΈλ₯Ό μΈμ μ―€ κΈ°λν μ μμμ§ λ§μν΄ μ£Όμκ² μ΅λκΉ? |
| Helmy Eltoukhy: Co-Founder, Co-CEO & Chairman Yes. We're excited about Reveal Ultra, making good progress there. We're on track for launching it this year. And it's something where we believe that the true clinical sensitivity of that test will be best-in-class. I think there's a lot of I would say, contrived messaging in the space in terms of different bars that people are using, but we believe that this will, I think, redefine sensitivity in the tumor-informed space. There are other features of the test. It's going to do more than, I think, other tumor-informed offerings. We always have a special sauce at Guardant with all our tests in terms of when we launch them. And so I think I would just say stay tuned as we share more details later this year about that test. | **Helmy Eltoukhy:** λ€, λ¦¬λΉ μΈνΈλΌ(Reveal Ultra)μ λν΄ λ§€μ° κΈ°λνκ³ μμΌλ©°, μμ‘°λ‘κ² μ§νλκ³ μμ΅λλ€. μ¬ν΄ μΆμλ₯Ό λͺ©νλ‘ μ°¨μ§ μμ΄ μ€λΉνκ³ μμ΅λλ€. κ·Έλ¦¬κ³ μ ν¬λ μ΄ ν
μ€νΈμ μ§μ ν μμμ λ―Όκ°λ(clinical sensitivity)κ° λκΈ μ΅κ³ (best-in-class)κ° λ κ²μ΄λΌκ³ λ―Ώκ³ μμ΅λλ€. μ΄ λΆμΌμμ μ¬λλ€μ΄ λ€μν κΈ°μ€μ μ¬μ©νλ©° λ€μ μΈμμ μΈ λ©μμ§λ₯Ό λ΄λλ κ²½μ°κ° λ§λ€κ³ μκ°ν©λλ€λ§, μ ν¬λ μ΄ ν μ€νΈκ° μ’ μ μ 보 κΈ°λ°(tumor-informed) λΆμΌμμ λ―Όκ°λ(sensitivity)μ κΈ°μ€μ μ¬μ μν κ²μ΄λΌκ³ λ―Ώμ΅λλ€. μ΄ ν μ€νΈμλ λ€λ₯Έ κΈ°λ₯λ€λ λ§μ΅λλ€. λ€λ₯Έ μ’ μ μ 보 κΈ°λ°(tumor-informed) μ νλ€λ³΄λ€ λ λ§μ κ²μ μ 곡ν κ²μ΄λΌκ³ μκ°ν©λλ€. κ°λνΈ(Guardant)λ λͺ¨λ ν μ€νΈλ₯Ό μΆμν λλ§λ€ νμ νΉλ³ν κ°μ (special sauce)μ κ°μ§κ³ μμ΅λλ€. λ°λΌμ, μ¬ν΄ λ§ μ΄ ν μ€νΈμ λν λ λ§μ μΈλΆ μ 보λ₯Ό 곡μ ν λκΉμ§ κ³μν΄μ κ΄μ¬μ κ°μ Έμ£ΌμκΈ°λ₯Ό λΆνλ립λλ€. |
| Operator: The next question comes from the line of Andrew Brackmann with William Blair. | **Operator:** λ€μ μ§λ¬Έμ μ리μ λΈλ μ΄(William Blair)μ μ€λλ₯ λΈλλ§(Andrew Brackmann)λκ» λλ¦¬κ² μ΅λλ€. |
| Andrew Brackmann: William Blair & Company L.L.C., Research Division AmirAli, you sort of talked about the recent MCED legislation and sort of the longer-term impact there. Can you maybe just sort of broaden out that commentary, talk to us sort of about the importance there for Shield in particular? And as you sort of think about the necessary steps for Guardant to sort of take advantage of that, can you just remind us on sort of the data generation and sort of path to FDA approval here? | **Andrew Brackmann:** μ΅κ·Ό MCED (Multi-Cancer Early Detection) λ²μκ³Ό κ·Έ μ₯κΈ°μ μΈ μν₯μ λν΄ μΈκΈνμ ¨μ΅λλ€. κ·Έ λ΄μ©μ μ’ λ νλκ² μ€λͺ ν΄ μ£Όμκ³ , νΉν Shieldμ μμ΄μμ μ€μμ±μ λν΄ λ§μν΄ μ£Όμκ² μ΅λκΉ? λν, Guardantκ° μ΄ κΈ°νλ₯Ό νμ©νκΈ° μν νμμ μΈ λ¨κ³λ€μ κ³ λ €νμ€ λ, λ°μ΄ν° μμ±(data generation)κ³Ό FDA μΉμΈ(FDA approval) κ²½λ‘μ λν΄ λ€μ νλ² μ€λͺ ν΄ μ£Όμλ©΄ κ°μ¬νκ² μ΅λλ€. |
| Co-CEO & Director: Yes. So I think we're talking about this MCED deal that just passed. So we are -- as I mentioned in the prepared remarks, we are encouraged to see the passage of the legislation. It's moving the whole field forward, but it's not going to be a meaningful driver of our business based on the business plan that we have in near term. Again, it's good for the field. Maybe as we go through midterm and talking about more than triannual testing with Shield, maybe there would be opportunities enable with this MCED deal for us. But again, in near term, we don't look at it as a meaningful driver of our business. | **Co-CEO & Director:** λ€, λ°©κΈ ν΅κ³Όλ MCED λ²μμ λν΄ λ§μνμλ κ² κ°μ΅λλ€. μ κ° λͺ¨λ λ°μΈ(prepared remarks)μμ λ§μλλ Έλ―μ΄, μ΄λ² λ²μ ν΅κ³Όλ₯Ό κΈμ μ μΌλ‘ λ³΄κ³ μμ΅λλ€. μ΄ λ²μμ μ 체 μ°μ
λΆμΌλ₯Ό λ°μ μν€λ λ° κΈ°μ¬ν κ²μ
λλ€. νμ§λ§ λ¨κΈ°μ μΌλ‘(near term) μ ν¬ μ¬μ
κ³ν(business plan)μ λΉμΆμ΄ λ³Ό λ, μ ν¬ μ¬μ
μ μλ―Έ μλ μ±μ₯ λλ ₯(meaningful driver)μ΄ λμ§λ μμ κ²μ
λλ€. λ€μ λ§μλ리μ§λ§, μ°μ μ λ°μλ μ’μ μμμ λλ€. μ€κΈ°μ μΌλ‘(midterm) λ³Ό λ, κ·Έλ¦¬κ³ Shieldλ₯Ό ν΅ν 3λ μ£ΌκΈ° μ΄μμ κ²μ¬(triannual testing)μ λν΄ λ Όμνκ² λλ€λ©΄, μ΄ MCED λ²μμ ν΅ν΄ μ ν¬μκ² κΈ°νκ° μκΈΈ μλ μμ κ²μ λλ€. νμ§λ§ λ€μ νλ² κ°μ‘°νμ§λ§, λ¨κΈ°μ μΌλ‘λ μ ν¬ μ¬μ μ μλ―Έ μλ μ±μ₯ λλ ₯μΌλ‘ 보μ§λ μμ΅λλ€. |
| Operator: The next question comes from the line of Subbu Nambi with Guggenheim. | **Operator:** λ€μ μ§λ¬Έμ ꡬκ²νμ(Guggenheim)μ μλΆ λ¨λΉλκ»μ ν΄μ£Όμκ² μ΅λλ€. |
| Subhalaxmi Nambi: Guggenheim Securities, LLC, Research Division A follow-up to Andrew's question, AmirAli. What has the opt-in rate for MCED Shield been so far? And if you were to accumulate significant data by year-end, would you be able to submit something to the FDA for RSE approval? I know it doesn't matter to the core story, but just trying to figure out as we think about upside. | **Subhalaxmi Nambi:** MCED Shieldμ μ΅νΈμΈ(opt-in)μ¨μ νμ¬ μ΄λ μ λμ λκΉ? κ·Έλ¦¬κ³ λ§μ½ μ°λ§κΉμ§ μλΉν λ°μ΄ν°λ₯Ό μΆμ νκ² λλ€λ©΄, RSE μΉμΈ(approval)μ μν΄ FDAμ μλ£λ₯Ό μ μΆν μ μμκΉμ? ν΅μ¬μ μΈ μ¬μ λ°©ν₯κ³Όλ μ§μ μ μΈ κ΄λ ¨μ΄ μλ€λ κ²μ μμ§λ§, μ μ¬μ μμΉ μ¬λ ₯(upside)μ κ³ λ €ν λ κΆκΈν΄μ μ¬μ€λ΄ λλ€. |
| Co-CEO & Director: Yes. Thanks for this important question. When we are thinking about the data that now we are generating with this MCD offering for Shield when the physician and patients are opting in. On one side, we are really encouraged by the enthusiasm that we are seeing on the provider side and participation by patients to opt in to release their medical record to us. On the other side, on the data side, I think in hopefully, in near future, we would be the company that has access to the widest, broadest clinical data in terms of clinical utility of MCD testing in U.S. patient population. So we are seeing good adoption rate. I don't want to get to the exact number of it. It's trending up, but so far, so good. So far, so good, and we are very excited with it. | **Co-CEO & Director:** λ€. μ€μν μ§λ¬Έ κ°μ¬ν©λλ€. μ ν¬κ° Shieldλ₯Ό μν MCD μλΉμ€(MCD offering)λ₯Ό ν΅ν΄ μμ¬μ νμλ€μ΄ λμ(opt-in)νλ©΄μ νμ¬ μμ±νκ³ μλ λ°μ΄ν°μ λν΄ λ§μλ리μλ©΄, ννΈμΌλ‘λ μλ£κΈ°κ΄(provider) μΈ‘μμ 보μ΄λ μ΄μμ νμλ€μ΄ μ ν¬μκ² μλ£ κΈ°λ‘μ μ 곡νλ λ° λμ(opt-in)νλ μ°Έμ¬μ¨μ λ§€μ° κ³ λ¬΄λμ΄ μμ΅λλ€. λ€λ₯Έ ννΈμΌλ‘λ, λ°μ΄ν° μΈ‘λ©΄μμ λ³Ό λ, λ°λΌκ±΄λ κ°κΉμ΄ λ―Έλμ μ ν¬λ λ―Έκ΅ νμ μ§λ¨μμ MCD κ²μ¬μ μμμ μ μ©μ±(clinical utility) μΈ‘λ©΄μμ κ°μ₯ κ΄λ²μνκ³ νλμ μμ λ°μ΄ν°(clinical data)μ μ κ·Όν μ μλ νμ¬κ° λ κ²μ΄λΌκ³ μκ°ν©λλ€. λ°λΌμ μ ν¬λ μ’μ μ±νλ₯ (adoption rate)μ 보μ΄κ³ μμ΅λλ€. μ νν μμΉλ₯Ό λ§μλ리기λ μ΄λ ΅μ§λ§, μ¦κ° μΆμΈμ μμΌλ©°, μ§κΈκΉμ§λ λ§€μ° μμ‘°λ‘μ΅λλ€. μ§κΈκΉμ§λ λ§€μ° μμ‘°λ‘μ°λ©°, μ ν¬λ μ΄μ λν΄ λ§€μ° κΈ°λκ° ν½λλ€. |
| Operator: The next question comes from the line of Michael Ryskin with Bank of America. | **Operator:** λ€μ μ§λ¬Έμ λ± ν¬ μ€λΈ μλ©λ¦¬μΉ΄(Bank of America)μ λ§μ΄ν΄ 리μ€ν¨λκ»μ ν΄μ£Όμκ² μ΅λλ€. |
| Unknown Analyst: This is Aaron on for Mike. Can you talk a little bit more about the puts and takes of the Shield guide? Obviously, 4Q saw the 14,000 sequential volume growth. But should we thinking about that as more of an anomaly and just kind of thinking about how much conservatism is embedded within the guide? And I guess the second part of that is thinking about Quest and PathGroup, those look like upsides to the guidance. And so how should we be thinking about the timing of those impacts of those tailwinds as we head through the year? | **Unknown Analyst:** μ΄λ κ°μ΄λμ€(Shield guidance)μ κΈμ μ λ° λΆμ μ μμΈ(puts and takes)μ λν΄ μ’ λ μμΈν λ§μν΄ μ£Όμκ² μ΅λκΉ? λ¬Όλ‘ 4λΆκΈ°μλ 14,000건μ μμ°¨μ λ¬Όλ μ¦κ°(sequential volume growth)κ° μμμ΅λλ€. νμ§λ§ μ ν¬λ μ΄λ₯Ό μ΄λ‘μ μΈ νμμΌλ‘ λ΄μΌ ν κΉμ, μλλ©΄ κ°μ΄λμ€μ μ΄λ μ λμ 보μμ±(conservatism)μ΄ λ°μλμ΄ μλ€κ³ λ³Ό μ μμκΉμ? κ·Έλ¦¬κ³ λ λ²μ§Έ μ§λ¬Έμ νμ€νΈ(Quest)μ ν¨μ€κ·Έλ£Ή(PathGroup)μ κ΄ν κ²μ λλ€. μ΄λ€μ κ°μ΄λμ€μ κΈμ μ μΈ μν₯ μμΈ(upsides)μΌλ‘ 보μ λλ€. μ¬ν΄λ₯Ό 보λ΄λ©΄μ μ΄λ¬ν μν(tailwinds)μ μν₯μ΄ μΈμ μ―€ λνλ κ²μΌλ‘ μμν΄μΌ ν κΉμ? |
| Co-CEO & Director: Yes, sure. Look, obviously, we are very excited with this guide of like 87,000 volume going to midpoint of 217,000 and a very huge revenue growth and contribution. On the other side, when we are thinking about the guide, we are, again, just in the -- still very early inning of this launch. This is just the second year of launch, and we want to be thoughtful with our guidance. We typically don't want to get too excited and get ahead of our skis just based on 1 quarter performance. But the trends are very positive. We are, again, very excited of how 2026 is going to shape out for us. In the prepared remarks, we talked about some of the 1Q seasonality in PCP offices is kind of normal. for us, again, in terms of year-over-year growth for us, I think we are very excited with the guide that we put out there. And there are some upside. We'll see like we are very optimistic about ACS guideline, and we believe it should be near. It's not part of our guide right now until they update their guideline. Quest, PathGroup, very minor contribution. We are counting on some benefit of the EMR connectivity enabled through this Quest and PathGroup integration, but we are not counting any kind of contribution in terms of the volume contribution of the co-promotion and volume that comes from Quest salespeople. We are going to monitor it. It should be positive, but since we don't know exactly how positive it would be, we want to monitor for the first few months of the launch and see how it goes. And then if appropriate, we would adjust our guidance accordingly. But we just want to be thoughtful about that matter as well. | **Co-CEO & Director:** λ€, λ¬Όλ‘ μ
λλ€. λΆλͺ
ν λ§μλ리μλ©΄, μ ν¬λ μ΄λ² κ°μ΄λμ€(guidance)μ λν΄ λ§€μ° κ³ λ¬΄λμ΄ μμ΅λλ€. 87,000건μ λ¬Όλμ΄ μ€κ°κ°μΈ 217,000건μΌλ‘ λμ΄λκ³ , λ§€μ° ν° λ§€μΆ μ±μ₯(revenue growth)κ³Ό κΈ°μ¬λ₯Ό μμνκ³ μμ΅λλ€. λ€λ₯Έ ννΈμΌλ‘λ, μ ν¬κ° κ°μ΄λμ€λ₯Ό κ³ λ €ν λ, μ ν¬λ μ¬μ ν μ΄λ² μΆμ(launch)μ μμ£Ό μ΄κΈ° λ¨κ³μ μμ΅λλ€. μ΄μ μΆμ 2λ μ°¨μΌ λΏμ΄λ©°, κ·Έλ κΈ°μ κ°μ΄λμ€λ₯Ό μ μ€νκ² μ μνκ³ μ ν©λλ€. μ ν¬λ λ³΄ν΅ λ¨ ν λΆκΈ° μ€μ (performance)λ§μ κ°μ§κ³ λ무 μ±κΈνκ² μμλκ°κ³ μΆμ§ μμ΅λλ€. νμ§λ§ μΆμΈλ λ§€μ° κΈμ μ μ λλ€. μ ν¬λ 2026λ μ΄ μ ν¬μκ² μ΄λ»κ² μ κ°λ μ§ λ€μ νλ² λ§€μ° κΈ°λνκ³ μμ΅λλ€. μ¬μ λ°ν(prepared remarks)μμ λ§μλλ Έλ―μ΄, PCP μ¬λ¬΄μ€μ 1λΆκΈ° κ³μ μ±(seasonality)μ μ΄λ μ λ μ μμ μΈ νμμ λλ€. μ ν¬λ λ€μ νλ² μ λ λλΉ μ±μ₯λ₯ (year-over-year growth) μΈ‘λ©΄μμ, μ ν¬κ° μ μν κ°μ΄λμ€(guidance)μ λν΄ λ§€μ° κ³ λ¬΄μ μΌλ‘ μκ°νκ³ μμ΅λλ€. κ·Έλ¦¬κ³ μΆκ°μ μΈ μμΉ μ¬λ ₯λ μλ€κ³ λ΄ λλ€. μ§μΌλ΄μΌκ² μ§λ§, μ ν¬λ ACS κ°μ΄λλΌμΈμ λν΄ λ§€μ° λκ΄μ μ΄λ©°, κ³§ λ°νλ κ²μΌλ‘ μμνκ³ μμ΅λλ€. κ·Έλ€μ΄ κ°μ΄λλΌμΈμ μ λ°μ΄νΈνκΈ° μ κΉμ§λ νμ¬λ‘μλ μ ν¬ κ°μ΄λμ€μ ν¬ν¨λμ΄ μμ§ μμ΅λλ€. νμ€νΈ(Quest)μ ν¨μ€κ·Έλ£Ή(PathGroup)μ κΈ°μ¬λλ λ§€μ° λ―Έλ―Έν κ²μ λλ€. νμ€νΈμ ν¨μ€κ·Έλ£Ή ν΅ν©μ ν΅ν΄ κ°λ₯ν΄μ§ EMR(Electronic Medical Record) μ°κ²°μ±μΌλ‘ μΈν μΌλΆ μ΄μ μ κΈ°λνκ³ μμ΅λλ€λ§, 곡λ νλ‘λͺ¨μ (co-promotion)μ΄λ νμ€νΈ μμ μ¬μλ€λ‘λΆν° λ°μνλ λ¬Όλ(volume) κΈ°μ¬ μΈ‘λ©΄μμλ μ΄λ ν κΈ°μ¬λ κ³μ°μ λ£κ³ μμ§ μμ΅λλ€. μ ν¬λ μ΄ μν©μ κ³μ μ£Όμν μμ μ λλ€. κΈμ μ μΈ μν₯μ΄ μμ κ²μΌλ‘ 보μ΄μ§λ§, κ·Έ μ λλ₯Ό μ νν κ°λ νκΈ° μ΄λ ΅κΈ° λλ¬Έμ, μΆμ(launch) μ΄κΈ° λͺ λ¬κ°μ μν©μ λͺ¨λν°λ§(monitoring)νλ©° μΆμ΄λ₯Ό μ§μΌλ³΄κ³ μ ν©λλ€. κ·Έ ν μ μ ν μμ μ κ·Έμ λ§μΆ° κ°μ΄λμ€(guidance)λ₯Ό μ‘°μ ν μμ μ λλ€. λ€λ§, μ΄ μ¬μμ λν΄μλ μ ν¬λ μ μ€νκ² μ κ·Όνκ³ μ ν©λλ€. |
| Operator: The next question comes from the line of Mark Massaro with BTIG. | **Operator:** λ€μ μ§λ¬Έμ μ ν μ°κ²°λ λΆμΌλ‘λΆν° λ°κ² μ΅λλ€. |
| Mark Massaro: BTIG, LLC, Research Division I wanted to also ask about Shield. So for AmirAli, one of the success stories of -- one of the drivers of the success of Cologuard was their direct-to-consumer TV launch. How are you thinking about spending in 2026? Is it more Select digital? Or do you anticipate some spend on TV? And then I also wanted to ask about Quest. There is access for the, I believe, the Quest salespeople to promote Shield. I just want to double check that these reps are incentivized. And then can you just maybe give us a sense for where the Shield test might sit in their bag relative to the other products they're selling? | **Mark Massaro:** μ΄λ(Shield)μ λν΄μλ μ§λ¬Έλλ¦¬κ² μ΅λλ€. μλ―Έλ₯΄μ리(AmirAli)λκ», μ½λ‘κ°λ(Cologuard) μ±κ³΅μ μ£Όμ λλ ₯ μ€ νλλ μλΉμ μ§μ νλ§€(direct-to-consumer) λ°©μμ TV λ‘ μΉμ΄μμ΅λλ€. 2026λ
μ§μΆ κ³νμ μ΄λ»κ² ꡬμνκ³ κ³μ κ°μ? λμ§νΈ λ§μΌν
(Select digital)μ λ μ§μ€νμ€ κ±΄μ§, μλλ©΄ TV κ΄κ³ μλ μΌμ λΆλΆ μ§μΆμ μμνκ³ κ³μ μ§ κΆκΈν©λλ€. κ·Έλ¦¬κ³ νμ€νΈ(Quest) κ΄λ ¨ν΄μλ μ§λ¬Έμ΄ μμ΅λλ€. νμ€νΈ μμ μ¬μλ€μ΄ μ΄λλ₯Ό ν보ν μ μλ κΆνμ΄ μλ κ²μΌλ‘ μκ³ μμ΅λλ€. μ΄ μμ μ¬μλ€μκ² μΈμΌν°λΈκ° μ 곡λλμ§ λ€μ νλ² νμΈν΄ μ£Όμκ² μ΅λκΉ? λν, νμ€νΈ μμ μ¬μλ€μ΄ νλ§€νλ λ€λ₯Έ μ νλ€κ³Ό λΉκ΅νμ λ, μ΄λ κ²μ¬κ° κ·Έλ€μ νλ§€ ν¬νΈν΄λ¦¬μ€(bag)μμ μ΄λ μ λμ λΉμ€μ μ°¨μ§νκ² λ μ§ λλ΅μ μΌλ‘ μ€λͺ ν΄ μ£Όμ€ μ μμκΉμ? |
| Co-CEO & Director: Yes. So some DTC pilot has actually happened for us in 2025 in select markets. And in 2026, we are excited that hopefully, consumers and even physicians would see even more of that. So we have some active campaigns that they are about to get finalized, and we are excited to put it out there and see what the impact would be. So we are very excited about it. The rest, stay tuned after we launch it in very near future. In terms of Quest, yes, actually, the salespeople are incentivized. It's part of their commission plan. And what we do know is actually it was very important and interesting for the Quest management team to get access to Shield as a very differentiated brand that gives them opportunity to talk about something new and something exciting with the accounts. So again, we are going to monitor how the launch goes with Quest in terms of co-promotion part of it. It should be again positive, but we'll see how positive it would be. | **Co-CEO & Director:** λ€, 2025λ
μ μΌλΆ μμ₯μμ DTC (Direct-to-Consumer) μλ² μ΄μμ΄ μ΄λ―Έ μ§νλμμ΅λλ€. κ·Έλ¦¬κ³ 2026λ
μλ μλΉμμ μλ£μ§λ€μ΄ λ λ§μ κ²μ μ νκ² λκΈ°λ₯Ό κΈ°λνκ³ μμ΅λλ€. νμ¬ λ§λ°μ§ μ‘°μ¨ λ¨κ³μ μλ μ¬λ¬ μΊ νμΈλ€μ΄ μμΌλ©°, μ΄λ₯Ό μ 보μ΄κ³ μ΄λ€ μν₯μ λ―ΈμΉ μ§ νμΈνλ κ²μ λν΄ λ§€μ° κΈ°λνκ³ μμ΅λλ€. μ ν¬λ μ΄μ λν΄ λ§€μ° κΈ°λκ° ν½λλ€. λλ¨Έμ§ λ΄μ©μ μ‘°λ§κ° μΆμλ ν λ€μ λ§μλλ¦¬κ² μ΅λλ€. νμ€νΈ(Quest)μ κ΄λ ¨ν΄μλ, λ€, μ€μ λ‘ μμ μ¬μλ€μκ² μΈμΌν°λΈ(incentive)κ° μ 곡λλ©°, μ΄λ κ·Έλ€μ 컀미μ (commission) κ³νμ μΌλΆμ λλ€. κ·Έλ¦¬κ³ μ ν¬κ° νμ νκΈ°λ‘λ, νμ€νΈ κ²½μμ§μκ²λ μ΄λ(Shield)λΌλ λ§€μ° μ°¨λ³νλ λΈλλ(brand)μ μ κ·Όν μ μλ€λ μ μ΄ λ§€μ° μ€μνκ³ ν₯λ―Έλ‘μ΄ λΆλΆμ΄μμ΅λλ€. μ΄λ κ³ κ°μ¬(accounts)λ€κ³Ό μλ‘κ³ ν₯λ―Έλ‘μ΄ μ΄μΌκΈ°λ₯Ό λλ κΈ°νλ₯Ό μ 곡νκΈ° λλ¬Έμ λλ€. λ€μ νλ² λ§μλ리μλ©΄, νμ€νΈ(Quest) μΆμμ κ΄λ ¨ν΄μ 곡λ νλ‘λͺ¨μ (co-promotion)μ΄ μ΄λ»κ² μ§νλλμ§ μ ν¬λ κ³μ μ§μΌλ³Ό μμ μ λλ€. λΆλͺ κΈμ μ μΈ ν¨κ³Όκ° μμ κ²μΌλ‘ 보μ΄μ§λ§, κ·Έ μ λκ° μΌλ§λ ν΄μ§λ μ’ λ λκ³ λ΄μΌ ν κ² κ°μ΅λλ€. |
| Operator: The next question comes from the line of Kyle Mikson with Canaccord. | **Operator:** λ€μ μ§λ¬Έμ Canaccordμ λλ€. |
| Kyle Mikson: Canaccord Genuity Corp., Research Division On the MetaSight acquisition, interesting to see that. Most of the consideration is tied to future commercial performance and the regulatory approval of the technology. So first one, wondering what the path is to noncancer launch is? And then second, it seems like they use mass spec, how does that factor into your NGS heavy platform? | **Kyle Mikson:** μ 곡ν΄μ£Όμ λ΄μ©μ μ λ리μ€νΈμ μ§λ¬Έμ
λλ€. κ²½μμ§μ λ΅λ³μ λ²μνλ €λ©΄ ν΄λΉ λ΅λ³ λ΄μ©μ μ 곡ν΄μ£Όμ
μΌ ν©λλ€. μ λ리μ€νΈμ μ§λ¬Έμ λ²μν΄μΌ νλ€λ©΄ λ€μκ³Ό κ°μ΄ λ²μν μ μμ΅λλ€: "μΊλμ½λ μ λ΄μ΄ν° 리μμΉ λλΉμ μ λλ€. λ©νμ¬μ΄νΈ μΈμμ λν΄ ν₯λ―Έλ‘κ² λ³΄κ³ μμ΅λλ€. μΈμ λκΈμ λλΆλΆμ΄ ν₯ν μμ μ μ±κ³Όμ κΈ°μ μ κ·μ μΉμΈμ μ°λλμ΄ μλκ΅°μ. 첫 λ²μ§Έ μ§λ¬Έμ λΉμ(non-cancer) λΆμΌ μΆμ κ²½λ‘λ μ΄λ»κ² λλμ§ κΆκΈν©λλ€. κ·Έλ¦¬κ³ λ λ²μ§Έλ‘, λ©νμ¬μ΄νΈκ° μ§λ λΆμλ²(mass spec)μ μ¬μ©νλ κ²μΌλ‘ 보μ΄λλ°, μ΄λ NGS(μ°¨μΈλ μΌκΈ°μμ΄ λΆμ) μ€μ¬ νλ«νΌμ μ΄λ»κ² ν΅ν©λ μμ μΈκ°μ?" νμ§λ§ κ²½μμ§μ λ΅λ³μ λ²μν΄μΌ νλ―λ‘, κ²½μμ§μ λ΅λ³ λ΄μ©μ μλ €μ£Όμλ©΄ μμ²νμ κ·μΉμ λ°λΌ λ²μν΄ λλ¦¬κ² μ΅λλ€. |
| Co-CEO & Director: Yes. So we are very actually excited about this acquisition to bring a very high-quality world experts on some specific complementary technologies to our Smart Platform. So we are very excited to go to work and see what we can do. It's a small technology talking again. So let us make more progress, and we will talk about it at the right time. | **Co-CEO & Director:** λ€, μ΄λ² μΈμμ λν΄ μ ν¬λ μ λ§ κΈ°λκ° ν½λλ€. μ ν¬ μ€λ§νΈ νλ«νΌ(Smart Platform)μ νΉμ 보μ κΈ°μ λΆμΌμ μΈκ³μ μΈ μ λ¬Έκ°λ€μ λͺ¨μκ² λμ΄ νΉν κ·Έλ μ΅λλ€. μ΄μ 본격μ μΌλ‘ μ 무μ μ°©μνμ¬ μ΄λ€ μλμ§λ₯Ό λΌ μ μμμ§ κΈ°λλ©λλ€. μμ§μ μ΄κΈ° λ¨κ³μ κΈ°μ μ λν μ΄μΌκΈ°μ΄λ―λ‘, λ λ§μ μ§μ μ μ΄λ£¬ νμ μ μ ν μμ μ λ€μ μμΈν λ§μλλ¦¬κ² μ΅λλ€. |
| Operator: The next question comes from the line of Casey Woodring with JPMorgan. | **Operator:** λ€μ μ§λ¬Έμ JPλͺ¨κ±΄(JPMorgan)μ μΌμ΄μ μ°λλ§λμ λλ€. |
| Casey Woodring: JPMorgan Chase & Co, Research Division Just a couple more on Shield maybe. So you mentioned that the guide is back half weighted. What does that guide imply for Shield in 1Q? I think that, that comment would imply a sizable step down sequentially. And then I guess, on the ACS commentary you made, if that hits in the first half of 2026, can you help us think about the upside to volumes in the back half of the year and what that could look like? | **Casey Woodring:** Shieldμ κ΄λ ¨ν΄μ λͺ κ°μ§ λ μ¬μκ² μ΅λλ€. κ°μ΄λμ€(guidance)κ° νλ°κΈ°μ μ§μ€λμ΄ μλ€κ³ λ§μνμ ¨λλ°, κ·Έλ λ€λ©΄ 1λΆκΈ° Shield μ€μ μλ μ΄λ€ μλ―Έκ° μμ΅λκΉ? μ μκ°μλ μ λΆκΈ° λλΉ μλΉν κ°μλ₯Ό μλ―Ένλ κ² κ°μ΅λλ€. κ·Έλ¦¬κ³ μΈκΈνμ ACS κ΄λ ¨ λ΄μ©μ λν΄ μ§λ¬Έλ립λλ€. λ§μ½ 2026λ μλ°κΈ°μ κ·Έ μν₯μ΄ λνλλ€λ©΄, κ·Έ ν΄ νλ°κΈ° λ¬Όλ(volumes)μ μμΉ μ¬λ ₯μ μ΄λ μ λκ° λ μ§, κ·Έλ¦¬κ³ κ΅¬μ²΄μ μΌλ‘ μ΄λ€ λͺ¨μ΅μΌμ§ μ€λͺ ν΄ μ£Όμ€ μ μμκΉμ? |
| Co-CEO & Director: Yes. Maybe I'll start with the ACS part. Let us actually see when it would happen. It should be in the near future. But I think when you think about there are about a dozen states that they have state-level mandates that even younger patient population should get access to the test. And the whole screening market is maybe about 40% this 65 year and above and more are, in fact, on the younger patient side. That could be an interesting upside and growth driver for us once we start really going much deeper on the commercial testing within those states. But let's first see actually when they update their guideline, and we go from there. In terms of Q1, yes, that's true that there is some Q1 seasonality in PCP offices, which in terms of screening and so forth. But our team has done a very good job to reschedule appointments that have been kind of impacted or the events that have been impacted. And we are on track to screen more patients in Q1 than in any other previous quarters. post launch. So let's see how the rest of the quarter goes, but -- and we will talk about this in our next earnings call. | **Co-CEO & Director:** λ€, ACS (American Cancer Society) λΆλΆλΆν° λ§μλλ¦¬κ² μ΅λλ€. μ€μ λ‘ μΈμ μ―€ νμ€νλ μ§λ μ§μΌλ΄μΌκ² μ§λ§, μ‘°λ§κ° μ΄λ£¨μ΄μ§ κ²μΌλ‘ 보μ
λλ€. νμ§λ§ μ½ 12κ° μ£Όμμλ λ μ μ νμμΈ΅λ κ²μ¬λ₯Ό λ°μ μ μλλ‘ μ£Ό μ°¨μμ μ무 κ·μ (mandates)μ μννκ³ μλ€λ μ μ κ³ λ €ν΄ λ³Ό νμκ° μμ΅λλ€. μ 체 μ λ³κ²μ¬(screening) μμ₯μ 보면, μ½ 40%κ° 65μΈ μ΄μμ΄κ³ , μ¬μ€ λ λ§μ λΆλΆμ΄ μ μ νμμΈ΅μ ν΄λΉν©λλ€. ν΄λΉ μ£Όλ€μμ μμ
μ κ²μ¬(commercial testing)λ₯Ό ν¨μ¬ λ μ¬μΈ΅μ μΌλ‘ μμνκ² λλ©΄, μ΄λ μ ν¬μκ² ν₯λ―Έλ‘μ΄ μμΉ μ¬λ ₯(upside)μ΄μ μ±μ₯ λλ ₯(growth driver)μ΄ λ μ μμ΅λλ€. νμ§λ§ μ°μ κ·Έλ€μ΄ μΈμ κ°μ΄λλΌμΈ(guideline)μ μ
λ°μ΄νΈνλμ§ μ§μΌλ³΄κ³ , κ·Έμ λ°λΌ μ§νν κ²μ
λλ€. 1λΆκΈ°(Q1)μ κ΄λ ¨ν΄μλ, λ€, 1μ°¨ μ§λ£ μμ(PCP offices)μμ μ λ³κ²μ¬(screening) λ±κ³Ό κ΄λ ¨νμ¬ 1λΆκΈ° κ³μ μ±(seasonality)μ΄ μλ€λ κ²μ μ¬μ€μ λλ€. νμ§λ§ μ ν¬ νμ΄ μν₯μ λ°μ μμ½μ΄λ νμ¬λ€μ μ¬μ‘°μ νλ λ° μ λ§ νλ₯νκ² λμ²νμ΅λλ€. κ·Έλ¦¬κ³ μ ν¬λ μΆμ μ΄ν κ·Έ μ΄λ€ λΆκΈ°λ³΄λ€λ 1λΆκΈ° (Q1)μ λ λ§μ νμλ₯Ό κ²μ§ν μμ μ΄λ©°, μ΄λ μμ‘°λ‘κ² μ§νλκ³ μμ΅λλ€. λ°λΌμ λ¨μ λΆκΈ°κ° μ΄λ»κ² μ§νλ μ§ μ§μΌλ΄μΌκ² μ§λ§, λ€μ μ€μ λ°ν (earnings call)μμ μ΄μ λν΄ λ€μ λ§μλλ¦¬κ² μ΅λλ€. |
| Operator: The next question comes from the line of Dan Arias with Stifel. | **Operator:** λ€μ μ§λ¬Έμ μ€ν°ν (Stifel)μ λ μ리μμ€λμ λλ€. |
| Paul Stewardson: Stifel, Nicolaus & Company, Incorporated, Research Division This is Paul on for Dan. I guess I just want to follow up on Subbu's question about kind of regulatory strategy for multi-cancer Shield. One of your competitors had some data out this afternoon with not meeting the primary endpoint with a very, very large MCED trial in terms of looking for stage shift. And then one other piece was this week in the New England Journal, there was some FDA willingness to be a little more flexible on what evidence generation might look like. I'm just wondering if any of these developments kind of influence what you would look to do for your evidence generation strategy and for your regulatory strategy with Shield MCD? | **Paul Stewardson:** μ 곡ν΄μ£Όμ λ΄μ©μ μ λ리μ€νΈμ μ§λ¬Έμ΄λ©°, κ²½μμ§μ λ΅λ³μ΄ μλλλ€. κ²½μμ§μ λ΅λ³μ λ²μνλ €λ©΄ ν΄λΉ λ΅λ³ λ΄μ©μ μ 곡ν΄μ£Όμ μΌ ν©λλ€. |
| Co-CEO & Director: Actually, this news just came out. So I don't know all the details of it. We've been on this call with you guys. But I think when I think about it, really, what is important in the field of multi-cancer detection is the performance of detecting early stages. And we believe with the technology that we have for Shield, the performance of early-stage detection as it's shown in CRC could be very interesting, and that could have a meaningful impact. On the other side, I think it really highlights what we are doing to capture all the clinical evidence, medical record of the patients who are going through MCD testing in U.S. and really establish the utility of this MCD testing at very large scale. We are going to benefit from this commercial scale of Shield, and we can put that evidence together in a very OpEx friendly and in a very quick way. So I think it's kind of -- we are getting more bullish with the pathway that we went after screening business and what we are doing with our MCED offering. | **Co-CEO & Director:** μ¬μ€, μ΄ μμμ λ°©κΈ λμ¨ κ²μ΄λΌμ λͺ¨λ μΈλΆ μ¬νμ λ€ μμ§λ λͺ»ν©λλ€. μ ν¬κ° μ§κΈ μ¬λ¬λΆκ³Ό ν΅ν μ€μ΄μμΌλκΉμ. νμ§λ§ μ΄μ κ΄λ ¨ν΄μ μ κ° μκ°νλ μ λ§ μ€μν μ μ, λ€μ€ μ μ‘°κΈ° μ§λ¨ (multi-cancer detection, MCD) λΆμΌμμ μ‘°κΈ° λ¨κ³ μμ νμ§νλ μ±λ₯μ΄λΌλ κ²μ λλ€. κ·Έλ¦¬κ³ μ ν¬λ Shield κΈ°μ μ ν΅ν΄ λμ₯μ (colorectal cancer, CRC) μ¬λ‘μμ 보μ¬μ§ κ²μ²λΌ μ‘°κΈ° λ¨κ³ μ§λ¨ μ±λ₯μ΄ λ§€μ° ν₯λ―Έλ‘μ΄ κ²°κ³Όλ₯Ό κ°μ Έμ¬ μ μμΌλ©°, μ΄λ μλΉν μν₯λ ₯μ λ―ΈμΉ μ μλ€κ³ λ―Ώμ΅λλ€. λ€λ₯Έ ννΈμΌλ‘λ, μ΄λ μ ν¬κ° λ―Έκ΅μμ MCD κ²μ¬λ₯Ό λ°λ νμλ€μ λͺ¨λ μμ μ¦κ±° (clinical evidence)μ μλ£ κΈ°λ‘ (medical record)μ μμ§νκ³ , μ΄ MCD κ²μ¬μ μ μ©μ± (utility)μ λκ·λͺ¨λ‘ ν립νκΈ° μν΄ μ§ννκ³ μλ λ Έλ ₯μ μ 보μ¬μ€λ€κ³ μκ°ν©λλ€. Shieldμ μμ μ κ·λͺ¨(commercial scale)λ₯Ό ν΅ν΄ μ°λ¦¬λ μ΄μ μ μ»κ² λ κ²μ΄λ©°, κ·Έ μ¦κ±°λ₯Ό μ΄μ λΉμ©(OpEx, Operating Expenses) μΈ‘λ©΄μμ λ§€μ° ν¨μ¨μ μ΄κ³ μ μνκ² μ·¨ν©ν μ μμ΅λλ€. λ°λΌμ μ λ μ€ν¬λ¦¬λ μ¬μ (screening business)μ μΆμ§ν΄ μ¨ λ°©ν₯κ³Ό MCED(Multi-Cancer Early Detection) μ 곡과 κ΄λ ¨νμ¬ μ°λ¦¬κ° μ§ννκ³ μλ μΌμ λν΄ λμ± λκ΄μ μΌλ‘ λ³΄κ³ μμ΅λλ€. |
| Operator: The next question comes from the line of Luke Sergott with Barclays. | **Operator:** λ€μ μ§λ¬Έμ λ°ν΄λ μ΄μ¦(Barclays)μ λ£¨ν¬ μκ³³(Luke Sergott)λκ»μ ν΄μ£Όμκ² μ΅λλ€. |
| Luke Sergott: Barclays Bank PLC, Research Division So on the Shield demand and after you guys have had this for 1.5 years now, but this is like the first full year of launch has been great. You're going to trend even further for next year. Can you kind of give us a sense of where the demand is coming from? Like how much of this is from the care gap closure versus winning share from colonoscopy or FIT or Cologuard or any of the other tests? | **Luke Sergott:** Shield μμμ λν΄ μ§λ¬Έλ립λλ€. μ νμ μΆμνμ μ§ 1λ λ° μ λ λμ ¨μ§λ§, μ΄λ²μ΄ 첫 μ¨μ ν ν ν΄μλλ° μ€μ μ΄ λ§€μ° νλ₯νμ΅λλ€. λ΄λ μλ λμ± μ±μ₯ν κ²μΌλ‘ μμλ©λλ€. μμκ° μ΄λμ μ€λμ§ μ’ λ ꡬ체μ μΌλ‘ μ€λͺ ν΄ μ£Όμ€ μ μμκΉμ? νΉν, μ΄ μμ μ€ μΌλ§λ λ§μ λΆλΆμ΄ μλ£ μλΉμ€ 격차 ν΄μ(care gap closure)μμ λΉλ‘―λ κ²μΈμ§, μλλ©΄ λμ₯ λ΄μκ²½(colonoscopy)μ΄λ FIT, μ½λ‘κ°λ(Cologuard) λ± λ€λ₯Έ κ²μ¬λ€λ‘λΆν° μμ₯ μ μ μ¨(market share)μ ν보ν κ²μΈμ§ κΆκΈν©λλ€. |
| Co-CEO & Director: Yes. So demand is coming from PCP physician in terms of patient type. Still, we are really focused on unscreened patient population. I think some of the latest data that I've seen about still 90% of the patients who are getting screened by Shield have not been screened before, at least during the last 5 years. when we got access to their medical record and claims. So really, our messaging is working, and we are increasing the rate of overall screening. Care gap and those kind of opportunities still is ahead of us. We need to get into -- we need to qualify for quality scores and Shield still is not. Once we get to the HEDIS, that would be a huge additional growth driver for us. So care gap program is not part of our growth right now. | **Co-CEO & Director:** λ€, νμ μ ν μΈ‘λ©΄μμ 보면 μμλ μΌμ°¨ μ§λ£ μμ¬(PCP physician)λ‘λΆν° λ°μνκ³ μμ΅λλ€. μ¬μ ν μ ν¬λ κ²μ§μ λ°μ§ μμ νμκ΅°μ μ§μ€νκ³ μμ΅λλ€. μ ν¬κ° μλ£ κΈ°λ‘κ³Ό μ²κ΅¬ λ΄μ(claims)μ νμΈν μ΅μ λ°μ΄ν°μ λ°λ₯΄λ©΄, Shieldλ₯Ό ν΅ν΄ κ²μ§μ λ°λ νμμ 90%λ μ μ΄λ μ§λ 5λ
κ° κ²μ§μ λ°μ μ μ΄ μλ λΆλ€μ΄μμ΅λλ€. λ°λΌμ μ ν¬μ λ©μμ§(messaging)μ΄ ν¨κ³Όλ₯Ό λ³΄κ³ μμΌλ©°, μ 체μ μΈ κ²μ§μ¨μ λμ΄κ³ μμ΅λλ€. μΌμ΄ κ°(care gap)κ³Ό κ°μ κΈ°νλ€μ μμ§ μ ν¬κ° νμ©ν μ¬μ§κ° λ§μ΅λλ€. μ ν¬λ νμ§ μ μ(quality scores)λ₯Ό μΆ©μ‘±ν΄μΌ νλλ°, Shieldλ μμ§ κ·Έ κΈ°μ€μ μΆ©μ‘±νμ§ λͺ»νκ³ μμ΅λλ€. HEDIS(Healthcare Effectiveness Data and Information Set) κΈ°μ€μ μΆ©μ‘±νκ² λλ©΄, μ΄λ μ ν¬μκ² μμ²λ μΆκ°μ μΈ μ±μ₯ λλ ₯(growth driver)μ΄ λ κ²μ λλ€. νμ¬ μΌμ΄ κ° νλ‘κ·Έλ¨μ μ ν¬ μ±μ₯μ κΈ°μ¬νκ³ μμ§ μμ΅λλ€. |
| Operator: The next question comes from the line of Jack Meehan with Nephron Research. | **Operator:** λ€μ μ§λ¬Έμ λ€νλ‘ λ¦¬μμΉ(Nephron Research)μ μ λ―Έν λκ»μ ν΄μ£Όμ ¨μ΅λλ€. |
| Nephron Research LLC: Appreciate all the color on the screening investments you're making. I was wondering if you could share color on the oncology side, specifically, just the mark-to-market, how large the sales force is there now and planned investments? And then second, you've talked about the NovaSeq X transition. When in the year is that taking place? And any way you can quantify level of savings you expect? | **Nephron Research LLC:** μ§ν μ€μ΄μ μ λ³ κ²μ¬(screening) ν¬μμ λν΄ μμΈν μ€λͺ
ν΄μ£Όμ
μ κ°μ¬ν©λλ€. μ’
μν(oncology) λΆλ¬Έμ λν΄μλ μ€λͺ
μ ν΄μ£Όμ€ μ μμκΉμ? νΉν, νμ¬ μμ₯ κ°μΉ(mark-to-market)λ μ΄λ μ λμΈμ§, νμ¬ μμ
μΈλ ₯(sales force) κ·λͺ¨λ μΌλ§λ λλμ§, κ·Έλ¦¬κ³ ν₯ν ν¬μ κ³νμ μ΄λ»κ² λλμ§ κΆκΈν©λλ€. λ λ²μ§Έ μ§λ¬Έμ λλ€. NovaSeq X μ νμ λν΄ λ§μνμ ¨λλ°μ, μ¬ν΄ μΈμ μ―€ μ νμ΄ μ΄λ£¨μ΄μ§ μμ μΈκ°μ? κ·Έλ¦¬κ³ μμνμλ μ κ°μ‘ κ·λͺ¨λ₯Ό μμΉμ μΌλ‘ λ§μν΄μ£Όμ€ μ μμκΉμ? |
| Helmy Eltoukhy: Co-Founder, Co-CEO & Chairman Yes. So I think obviously, as Mike said, we reached cash flow positivity on the oncology side last year. And obviously, we'll be generating cash this year. We're in a really good spot in terms of where we are with oncology. We've been essentially reinvesting in the business as a matter of course, as we see opportunities for growth on the sales side, as we see revenue per rep sort of grow, we saw tooth around a healthy number in terms of a matter of course, expansion of the team. And so we're in a healthy spot, and we'll continue to sort of invest where we see return on investment in terms of potential volume growth. In terms of the NovaSeq transition, maybe I'll let Mike take that one. | **Helmy Eltoukhy:** λ€, λ§μ΄ν¬κ° λ§μλλ Έλ―μ΄, μ ν¬λ μλ
μ μ’
μν(oncology) λΆλ¬Έμμ νκΈ νλ¦ νμ(cash flow positivity)λ₯Ό λ¬μ±νμ΅λλ€. κ·Έλ¦¬κ³ μ¬ν΄λ λΆλͺ
ν νκΈμ μ°½μΆν κ²μ
λλ€. μ’
μν λΆλ¬Έκ³Ό κ΄λ ¨ν΄μλ μ ν¬κ° λ§€μ° μ’μ μμΉμ μλ€κ³ μκ°ν©λλ€. μ ν¬λ μμ (sales) μΈ‘λ©΄μμ μ±μ₯ κΈ°νλ₯Ό ν¬μ°©νκ³ μμ μ¬μλΉ λ§€μΆ(revenue per rep)μ΄ μ¦κ°νλ κ²μ 보면μ, λΉμ°ν μ¬μ μ μ§μμ μΌλ‘ μ¬ν¬μν΄μμ΅λλ€. ν νμ₯ λν μμ°μ€λ½κ² 건μ ν μμ€μΌλ‘ μ΄λ£¨μ΄μ§λ κ²μ νμΈνμ΅λλ€. κ·Έλμ μ ν¬λ μ§κΈ 건μ ν μν©μ΄λ©°, μ μ¬μ μΈ λ¬Όλ(volume) μ±μ₯μ μν΄ ν¬μ μμ΅(return on investment, ROI)μ΄ μμλλ κ³³μ κ³μ ν¬μν κ²μ λλ€. NovaSeq μ νκ³Ό κ΄λ ¨ν΄μλ λ§μ΄ν¬μκ² μ€λͺ νλλ‘ νκ² μ΅λλ€. |
| Chief Financial Officer: Yes. We -- I mean, first of all, we successfully transitioned Reveal over to NovaSeq X just over a year ago as well as workflow efficiencies. We saw a nice reduction in the cost per test for Reveal. And with Guardant360, we started that transition. It will take time to fully be implemented. probably around about the middle of the year, I would expect all Guardant360 liquid tests to be on NovaSeq X. And yes, we expect to see a nice improvement in our cost per test. I think just put in to quantify it a little bit, our gross margin currently for Guardant360 is in the high 60s. And probably once we've gone through the full move to NovaSeq X and things are working properly, I expect to see maybe 200 basis point improvement and sort of pushing that Guardant360 gross margins into the low 70% level. So yes, no, we're feeling very positive about the switch, and it's going to have a nice impact on our P&L. | **Chief Financial Officer:** λ€, μ°μ 1λ
μ¬ μ μ Revealμ NovaSeq Xλ‘ μ±κ³΅μ μΌλ‘ μ ννκ³ , μ΄μ ν¨κ» μν¬νλ‘μ° ν¨μ¨μ±λ κ°μ νμ΅λλ€. κ·Έ κ²°κ³Ό Revealμ ν
μ€νΈλΉ λΉμ©(cost per test)μ΄ ν¬κ² μ€μμ΅λλ€. Guardant360μ κ²½μ°μλ μ΄λ¬ν μ ν μμ μ μμνμ΅λλ€. μμ ν ꡬνλκΈ°κΉμ§λ μκ°μ΄ μ’ κ±Έλ¦΄ κ²μΌλ‘ μμλ©λλ€λ§, μλ§λ μ¬ν΄ μ€λ°μ―€μλ λͺ¨λ Guardant360 μ‘체 μκ²(liquid biopsy) ν μ€νΈκ° NovaSeq Xμμ μ΄λ£¨μ΄μ§ κ²μΌλ‘ μμν©λλ€. λ€, κ·Έλ¦¬κ³ ν μ€νΈλΉ λΉμ©(cost per test)μμλ μλΉν κ°μ μ κΈ°λνκ³ μμ΅λλ€. μμΉλ‘ μ’ λ μ€λͺ λ리μλ©΄, νμ¬ Guardant360μ λ§€μΆ μ΄μ΄μ΅λ₯ (gross margin)μ 60% νλ°λμ λλ€. NovaSeq Xλ‘μ μμ ν μ νμ΄ μ΄λ£¨μ΄μ§κ³ λͺ¨λ μμ€ν μ΄ μ λλ‘ μλνκ² λλ©΄, μ½ 200bp(basis point) μ λμ κ°μ μ κΈ°λνκ³ μμ΅λλ€. μ΄λ₯Ό ν΅ν΄ Guardant360μ λ§€μΆμ΄μ΄μ΅λ₯ (gross margin)μ 70% μ΄λ°λκΉμ§ λμ΄μ¬λ¦΄ μ μμ κ²μΌλ‘ μμν©λλ€. λ°λΌμ μ ν¬λ μ΄λ² μ νμ λν΄ λ§€μ° κΈμ μ μΌλ‘ λ³΄κ³ μμΌλ©°, μ΄λ μ ν¬ μμ΅κ³μ°μ(P&L)μλ κΈμ μ μΈ μν₯μ λ―ΈμΉ κ²μ λλ€. |
| Helmy Eltoukhy: Co-Founder, Co-CEO & Chairman Operator, one more question please. | **Helmy Eltoukhy:** μ€νΌλ μ΄ν°λ, μ§λ¬Έ νλλ§ λ λΆνλ립λλ€. |
| Operator: Our last question comes from the line of Bill Bonello with Craig-Hallum. | **Operator:** μ ν¬μ λ§μ§λ§ μ§λ¬Έμ ν¬λ μ΄κ·Έ-ν λΌ(Craig-Hallum)μ λΉ λ³΄λ¬λ‘(Bill Bonello) μ λ리μ€νΈ(analyst)λκ»μ ν΄μ£Όμκ² μ΅λλ€. |
| William Bonello: Craig-Hallum Capital Group LLC, Research Division So this one, I guess, is probably for Helmy. I think the -- if I understand it right, that the FDA approval would open the door to physicians being able to order both tissue and blood from Guardant concurrently. I'm just curious what your sense of is for the appetite for using both tests upfront and then also touch on maybe any reimbursement challenges that you might anticipate if that becomes more common. | **William Bonello:** μ΄λ² μ§λ¬Έμ ν¬λ―Έλκ» λ리λ κ² κ°μ΅λλ€. μ κ° μ λλ‘ μ΄ν΄νλ€λ©΄, FDA μΉμΈμ μμ¬λ€μ΄ Guardantμ μ‘°μ§ κ²μ¬(tissue test)μ νμ‘ κ²μ¬(blood test)λ₯Ό λμμ μλ’°ν μ μλ κΈΈμ μ΄μ΄μ€ κ²μ΄λΌκ³ μκ°ν©λλ€. λ κ°μ§ κ²μ¬λ₯Ό μ΄κΈ° λ¨κ³λΆν° λͺ¨λ μ¬μ©νλ κ²μ λν μμκ° μ΄λ μ λ λ κ²μΌλ‘ 보μλμ§ κΆκΈν©λλ€. λλΆμ΄, μ΄λ¬ν λ°©μμ΄ λ³΄νΈνλ κ²½μ° μμλλ 보ν κΈμ¬(reimbursement) κ΄λ ¨ μ΄λ €μμ μλμ§μ λν΄μλ λ§μν΄μ£Όμλ©΄ κ°μ¬νκ² μ΅λλ€. |
| Helmy Eltoukhy: Co-Founder, Co-CEO & Chairman Yes. As you know, guidelines, I think, are increasingly recommending that for patients upfront, especially in lung cancer and breast cancer, which are some of our 2 largest indications for 360. And one of the challenges is the way that LDT is reimbursed, it really is not possible to order them concurrently. And so that's obviously been a little bit of a headwind that sort of will become a tailwind once we get FDA approval for Guardant360. So we do see that as a potential driver. Obviously, we want to make sure it's done in the cases where it's -- there's clinical utility for the patients and value for treatment selection. But we're very confident that I think will be, I think, important catalyst for our tissue business going forward. | **Helmy Eltoukhy:** λ€, μμλ€μνΌ κ°μ΄λλΌμΈ(guidelines)μμ νμλ€μκ² μ μ μ μΌλ‘(upfront) κ²μ¬λ₯Ό κΆκ³ νλ μΆμΈκ° μ μ κ°ν΄μ§κ³ μμ΅λλ€. νΉν νμκ³Ό μ λ°©μμ μ ν¬ Guardant360μ κ°μ₯ ν° λ κ°μ§ μ μμ¦(indications) μ€ νλμ
λλ€. κ·Έλ°λ° ν κ°μ§ μ΄λ €μ΄ μ μ LDT(Laboratory Developed Test)μ 보ν μν(reimbursement) λ°©μ λλ¬Έμ λμμ κ²μ¬λ₯Ό μ²λ°©νκΈ°κ° μ¬μ€μ λΆκ°λ₯νλ€λ κ²μ λλ€. μ΄ λΆλΆμ΄ μ§κΈκΉμ§λ λ€μ μν(headwind)μΌλ‘ μμ©νμ§λ§, Guardant360μ λν FDA μΉμΈ(approval)μ λ°κ² λλ©΄ μν(tailwind)μΌλ‘ λ°λ κ²μ΄λΌκ³ λ΄ λλ€. λ°λΌμ μ ν¬λ μ΄λ₯Ό μ μ¬μ μΈ μ±μ₯ λλ ₯(driver)μΌλ‘ λ³΄κ³ μμ΅λλ€. λ¬Όλ‘ , νμλ€μκ² μμμ μ μ©μ±(clinical utility)μ΄ μκ³ μΉλ£λ² μ νμ κ°μΉκ° μλ κ²½μ°μλ§ κ²μ¬κ° μ΄λ£¨μ΄μ§λλ‘ ν κ²μ λλ€. νμ§λ§ μ ν¬λ μ΄κ²μ΄ μμΌλ‘ μ ν¬ μ‘°μ§ κ²μ¬(tissue business) μ¬μ μ μ€μν μ΄λ§€μ (catalyst)κ° λ κ²μ΄λΌκ³ λ§€μ° νμ ν©λλ€. |
| Operator: Due to the interest of time, that was our last question. That will conclude today's call. Thank you for your participation, and enjoy the rest of your day. | **Operator:** μκ° κ΄κ³μ, λ§μ§λ§ μ§λ¬Έμ΄μμ΅λλ€. μ΄κ²μΌλ‘ μ€λ 컨νΌλ°μ€ μ½μ λ§μΉκ² μ΅λλ€. μ°Έμ¬ν΄μ£Όμ μ κ°μ¬ν©λλ€. λ¨μ ν루 μ 보λ΄μμμ€. |
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