GeneDx Holdings Corp (WGS) 2025 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good day, and thank you for standing by. Welcome to the GeneDx third-quarter 2025 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

    您好,感謝您的耐心等待。歡迎參加 GeneDx 2025 年第三季財報電話會議。(操作人員指示)請注意,今天的會議正在錄音。

  • I would now like to turn the conference over to Sabrina Dunbar, Investor Relations. Please go ahead.

    現在我將把會議交給投資者關係部的 Sabrina Dunbar。請繼續。

  • Sabrina Dunbar - Investor Relations

    Sabrina Dunbar - Investor Relations

  • Thank you, operator, and thank you to everyone for joining us today. On the call, we have Katherine Stueland, President and Chief Executive Officer; Bryan Dechairo, Chief Operations Officer; and Kevin Feeley, Chief Financial Officer. Earlier today, GeneDx released financial results for the third quarter ended September 30, 2025.

    謝謝接線員,也謝謝今天所有收看節目的朋友。參與電話會議的有:總裁兼執行長 Katherine Stueland;營運長 Bryan Dechairo;以及財務長 Kevin Feeley。今天早些時候,GeneDx 發布了截至 2025 年 9 月 30 日的第三季財務業績。

  • Before we begin, please take note of our cautionary statement. We may make forward-looking statements on today's call, including about our business plans, updated 2025 guidance and outlook. Forward-looking statements inherently involve risks and uncertainties and only reflect our view as of today, October 28, and we are under no obligation to update.

    在開始之前,請注意我們的警示聲明。我們可能會在今天的電話會議上發表前瞻性聲明,包括關於我們的業務計劃、更新後的 2025 年業績指引和展望。前瞻性陳述本身涉及風險和不確定性,僅反映我們截至今天(10 月 28 日)的觀點,我們沒有義務更新。

  • When discussing our results, we refer to non-GAAP measures, which exclude certain items from reported results. Please refer to our third quarter 2025 earnings release and slides available at ir.genedx.com for definitions and reconciliations of non-GAAP measures and additional information regarding our results, including a discussion of factors that could cause actual results to materially differ from forward-looking statements.

    在討論我們的績效時,我們會參考非GAAP指標,這些指標從報告的績效中剔除了某些項目。有關非GAAP指標的定義和調節以及有關我們業績的更多信息,請參閱我們在ir.genedx.com上發布的2025年第三季度收益報告和幻燈片,其中討論了可能導致實際結果與前瞻性聲明存在重大差異的因素。

  • And with that, I'll turn the call over to Katherine.

    那麼,我就把電話交給凱瑟琳了。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Thank you, Sabrina, and good morning, everyone. The third quarter was another exceptional quarter for GeneDx. We continued to drive record growth while maintaining our commitment to profitability. For us, better patient care and profitability go hand in hand, because our ambition is truly transformative to fundamentally alter how precision healthcare is delivered, making it more accessible, effective, and patient-sensitive.

    謝謝你,薩布麗娜,大家早安。第三季對 GeneDx 來說又是個業績斐然的季度。我們在保持獲利能力的同時,繼續保持著創紀錄的成長。對我們來說,更好的病患照護和獲利能力是相輔相成的,因為我們的目標是真正具有變革意義,從根本上改變精準醫療的提供方式,使其更易於獲取、更有效、更以病患為中心。

  • We envision a world where any genetic disorder is diagnosed quickly to prevent disease progression and ensure everyone has a chance to live a long and healthy life. Achieving that vision requires a fast-growing, disciplined, profitable business that delivers both life-changing answers for patients and long-term values for shareholders. Based on our momentum exiting this quarter, we're raising our 2025 revenue guidance to $425 million to $428 million.

    我們設想這樣一個世界:任何遺傳疾病都能快速診斷,以防止疾病惡化,並確保每個人都有機會過著長壽和健康的生活。實現這個願景需要一個快速發展、紀律嚴明、獲利豐厚的企業,既能為患者提供改變人生的解決方案,又能為股東創造長期價值。根據我們本季末的成長勢頭,我們將 2025 年的營收預期上調至 4.25 億美元至 4.28 億美元。

  • Our North Star, the goal that drives each and every one of us at GeneDx, is to diagnose disease earlier for as many families as possible. Our strategy to do so is to: one, drive high profitable growth, two, offer the best-in-class diagnostic products and experience for clinicians and patients globally, and three, build the network of facts required to usher in the next era of precision medicine.

    我們GeneDx的北極星,也是我們每個人努力的目標,就是為盡可能多的家庭儘早診斷出疾病。我們實現這一目標的策略是:一、推動高利潤成長;二、為全球臨床醫生和患者提供一流的診斷產品和體驗;三、建構必要的知識網絡,以引領精準醫療的下一個時代。

  • Across all three focus areas, we are leveraging the power of GeneDx Infinity, the largest rare disease data sets to generate deep genomic insights that enable fast and reliable diagnoses and fuel the precision medicine revolution. Just last week, the FDA granted breakthrough device designations to our ExomeDx and GenomeDx tests, offering powerful validation that our industry-leading technology is the gold standard in transforming lives and shaping the future of health.

    在所有三個重點領域,我們都利用了 GeneDx Infinity(最大的罕見疾病資料集)的強大功能,以產生深入的基因組見解,從而實現快速可靠的診斷,並推動精準醫療革命。就在上週,FDA授予我們的ExomeDx和GenomeDx檢測突破性設備認定,這有力地證明了我們行業領先的技術是改變生活和塑造未來健康的黃金標準。

  • There are over 10,000 rare diseases impacted in one in 10 Americans, most of them children, and it still takes an average of five years to reach an accurate diagnosis. Receiving an accurate genetic diagnosis is a pivotal milestone in a patient's journey, but it's often not the end. Today, 95% of rare diseases have no approved treatment, that is the largest provider of rare disease diagnoses in the world. GeneDx will be central in changing that.

    超過 10,000 種罕見疾病影響著十分之一的美國人,其中大多數是兒童,而且平均仍需五年時間才能做出準確診斷。獲得準確的基因診斷是患者治療過程中的重要里程碑,但這往往並非終點。目前,95%的罕見疾病尚無核准的治療方法,而這正是全球最大的罕見疾病診斷機構。GeneDx 將在改變這種現狀中發揮核心作用。

  • As we look to our future, GeneDx isn't just a starting point for rare disease. We're the nexus connecting patients, biopharma, health systems, payers, policy makers, and advocacy to unlock the full potential of genomic medicine. We recently announced two key executive hires, Lisa Gurry as Chief Business Officer and Dr. Mimi Lee as Chief Precision Medicine Officer, to unite our data, diagnostics, and partnerships so that clinical adoption, equitable access, and therapeutic advancements reinforce one another, creating a network effect. We are uniquely positioned to move our system from sick care to healthcare, and strengthened by the network effects, we will deliver on the promise of precision medicine for all.

    展望未來,GeneDx 不僅是罕見疾病領域的一個起點。我們是連結患者、生物製藥公司、醫療系統、支付方、政策制定者和倡導者的紐帶,旨在釋放基因組醫學的全部潛力。我們最近宣布了兩項重要的高階主管任命,Lisa Gurry 擔任首席商務官,Mimi Lee 博士擔任首席精準醫療官,旨在整合我們的數據、診斷和合作夥伴關係,使臨床應用、公平獲取和治療進步相互促進,從而產生網絡效應。我們擁有獨特的優勢,可以將我們的系統從疾病治療轉變為醫療保健,並且借助網路效應,我們將實現為所有人提供精準醫療的承諾。

  • What fuels our business is growth and diagnostic testing at scale, and our strategy is twofold. We're deepening our penetration while widening the market enabling us to serve more patients today while opening access for patients tomorrow. Our existing markets of geneticists and pediatric neurologists continue to deliver impressive growth, and we have ample room to run. And with updated guidance from the American Academy of Pediatrics now in place, we can now shorten that multi-year diagnostic odyssey by meeting parents where they go first, their pediatrician. Our commercial build-out is underway, and we expect to nearly double our sales force over the coming quarters with a dedicated GeneDx team.

    推動我們業務發展的動力是規模化的成長和診斷測試,我們的策略是雙重的。我們正在加深市場滲透,同時擴大市場規模,使我們能夠為更多患者提供服務,並為未來的患者創造更多就醫機會。我們現有的遺傳學家和兒科神經科醫生市場持續保持著令人矚目的成長勢頭,我們還有很大的發展空間。隨著美國兒科學會更新了指導意見,我們現在可以透過先與家長見面(即兒科醫生)來縮短長達數年的診斷過程。我們的商業拓展工作正在進行中,我們預計在接下來的幾個季度裡,隨著專門的 GeneDx 團隊的成立,我們的銷售隊伍將增加近一倍。

  • We're also leading medical education on updated guidance, expanding GeneDx's authority as the leader in genomics to this new cohort of clinicians, many of whom are learning about these changes for the first time from us. We're also investing in customer experience to drive utilization. The opportunity is significant, and we expect it will take 18 to 24 months from the June update before we see real adoption.

    我們也在更新指南方面引領醫學教育,擴大 GeneDx 作為基因組學領導者的權威,使其惠及這群新的臨床醫生,其中許多人都是第一次從我們這裡了解這些變化。我們也正在加大對客戶體驗的投入,以提高使用率。這是一個巨大的機遇,我們預計從 6 月的更新到真正普及需要 18 到 24 個月的時間。

  • Turning to the inpatient setting, the NICU remains under-penetrated and continues to be a focus, with less than 5% of NICU patients receiving any genetic testing today. We have eight Epic Aura integrations live and are on top to deliver at least 12 by the end of the year. Our ultra-rapid genome continues to prove its value for critically ill infants and as protocols evolve and whole system engagement increases, we're well-positioned to significantly scale testing in Level 3 and Level 4 NICUs over time.

    就住院環境而言,新生兒加護病房 (NICU) 的基因檢測普及率仍然很低,仍然是關注的焦點,目前只有不到 5% 的 NICU 患者接受過任何基因檢測。我們目前已上線 8 個 Epic Aura 整合項目,並預計在年底前完成至少 12 個。我們的超快速基因組檢測不斷證明其對重症嬰兒的價值,隨著方案的改進和整個系統參與度的提高,我們有能力隨著時間的推移在 3 級和 4 級新生兒重症監護室中大幅擴大檢測規模。

  • Our work to date has shown the value of testing symptomatic patients, but we know the next step forward is to enable proactive personalized care beginning at the earliest moment possible. Our leadership in genomic newborn screening, from supporting pioneering research to enabling clinical adoption in Florida reflects our mission to drive true longevity and highlights our unique ability to expand access to this technology at scale.

    我們迄今為止的工作已經證明了對有症狀患者進行檢測的價值,但我們知道下一步是儘早開始主動提供個人化護理。我們在新生兒基因組篩檢領域的領導地位,從支持開創性研究到推動佛羅裡達州的臨床應用,體現了我們推動真正長壽的使命,並突顯了我們大規模推廣這項技術的獨特能力。

  • Our work on the GUARDIAN study generated foundational clinical data to support adoptions, demonstrating an over 3% true positive rate for actionable conditions at birth. This quarter, we announced our role in two new pivotal initiatives, the NIH's BEACON Program and the Sunshine Genetics Network. These programs are relying on GeneDx as a trusted advisor in newborn screening because we have the unique talent and experience to design programs that are clinically impactful, equitable, and scalable.

    我們在 GUARDIAN 研究中的工作產生了支持收養的基礎臨床數據,證明出生時可採取行動的疾病的真陽性率超過 3%。本季度,我們宣布了我們在兩項新的關鍵計劃中的角色,即美國國立衛生研究院的 BEACON 計劃和陽光遺傳學網絡。這些計畫之所以將 GeneDx 視為新生兒篩檢領域值得信賴的顧問,是因為我們擁有獨特的才能和經驗,能夠設計出具有臨床影響力、公平且可擴展的計畫。

  • Broad adoption of newborn screening will force the system from reactive to proactive, advancing our mission and accelerating impact at population scale. At the same time, exome and genome testing can have significant utility later in life. Adult conditions represent another large, untapped market, where GeneDx is uniquely positioned to offer diagnoses for cardiovascular conditions, neurodegenerative diseases, and many others. And as we grow our footprints domestically, we're also poised to address growing opportunities internationally.

    廣泛採用新生兒篩檢將迫使系統從被動應對轉變為主動出擊,從而推進我們的使命,並在人口規模上加速產生影響。同時,外顯子組和基因組檢測在晚年生活也具有重要的實用價值。成人疾病代表著另一個巨大的、尚未開發的市場,GeneDx 在該領域擁有獨特的優勢,可以提供心血管疾病、神經退化性疾病和許多其他疾病的診斷。隨著我們在國內業務的不斷拓展,我們也已做好準備,迎接國際上日益增長的機會。

  • The Fabric Genomics platform offers us flexibility to serve global markets at scale, and we're excited to have boots on the ground in key ex-US regions to develop these markets. We're proud to have built a business that delivers both purpose and profit to fuel reinvestment. And the strength of our model today is laying the foundation for an exciting future.

    Fabric Genomics 平台為我們提供了靈活地大規模服務全球市場的條件,我們很高興能在美國以外的主要地區派駐人員來開發這些市場。我們很自豪能夠打造一個既能實現目標又能獲利的企業,從而為再投資提供動力。我們模式的優勢如今正為令人振奮的未來奠定基礎。

  • With that, I'll pass it over to Kevin to share more about our results.

    接下來,我將把麥克風交給凱文,讓他來分享更多關於我們研究結果的資訊。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Good morning, everyone, and thanks for joining us today. We reported third quarter 2025 revenues of $116.7 million, a 52% increase year over year. That total includes $98.9 million in revenue from exome and genome, up 66% from the same quarter last year.

    各位早安,感謝大家今天收看我們的節目。我們公佈了 2025 年第三季營收為 1.167 億美元,年增 52%。該總額包括來自外顯子組和基因組的 9,890 萬美元收入,比去年同期成長 66%。

  • In the third quarter, we reported 25,702 exome and genome tests. Growth there has accelerated from 24% year over year in the first quarter to 29% in the second quarter to now 33% in the third quarter. We expect volume growth on these tests to continue to accelerate in Q4 and offer high growth for the foreseeable future.

    第三季度,我們報告了 25,702 例外顯子組和基因組檢測。該地區的成長率已從第一季的年增 24% 加速到第二季的 29%,目前第三季已達到 33%。我們預計這些測試的銷售成長將在第四季度繼續加速,並在可預見的未來保持高成長。

  • For those new to our story, the business began by serving expert clinical geneticist 25 years ago, and now 8 out of 10 in the US ordered their testing from GeneDx. I mentioned that because it's been just over two years since we began calling on pediatric neurologists and already a third of those physicians order from us. Over the next few years, we expect to pull volume from many more call points, the largest of which is the general pediatrician.

    對於不熟悉我們故事的人來說,這家公司 25 年前起步,服務於專業的臨床遺傳學家,現在美國十分之八的遺傳學家都從 GeneDx 訂購了檢測服務。我之所以提到這一點,是因為我們開始與兒科神經科醫生接洽至今已經兩年多了,其中已有三分之一的醫生向我們訂購產品。在接下來的幾年裡,我們預計會從更多的呼叫點獲取業務量,其中最大的呼叫點是兒科醫生。

  • Near-term growth should continue to be fueled by increased ordering patterns from existing accounts as they continue to convert from panels and activating more untapped pediatric neurologists. We'll also open up and penetrate additional pediatric and adult specialty call points and begin international market development. The NICU remains a compelling market for us, expected to ramp over the next several quarters and years. Of course, all of that is supplemented by the long-term potential to establish a commercial newborn screening market and by our ability to put Cenex Infinity work for biopharma and other healthcare partners in a way that contributes meaningfully to our revenue base.

    短期增長應繼續受到現有客戶訂單增加的推動,因為他們將繼續從小組轉化,並激活更多尚未開發的兒科神經科醫生。我們也將開拓和滲透更多的兒科和成人專科門診點,並開始國際市場開發。新生兒加護病房 (NICU) 對我們來說仍然是一個極具吸引力的市場,預計在未來幾季和幾年內將持續成長。當然,所有這些都得益於建立商業新生兒篩檢市場的長期潛力,以及我們能夠讓 Cenex Infinity 為生物製藥和其他醫療保健合作夥伴服務,從而為我們的收入基礎做出有意義的貢獻。

  • The average reimbursement rate for exome and genome was over $3,500 a test in the third quarter. That's up from approximately $3,700 last quarter and $3,100 a year ago. With a talented team in place, our cross-functional revenue cycle efforts are positively influencing Medicaid coverage expansion and fighting for fair adjudication. And there's one big recent development to share in that regard. On November 1, the largest state Medicaid program, Medi-Cal, will begin covering whole genome testing for their members in California. We applaud their decision to become what is now the 36th state to cover exome and genome outpatient.

    第三季度,外顯子組和基因組檢測的平均報銷率超過每次檢測 3500 美元。這比上季度的約 3700 美元和一年前的 3100 美元有所增長。憑藉著一支才華橫溢的團隊,我們的跨職能收入周期工作正在積極影響醫療補助覆蓋範圍的擴大,並爭取公平裁決。在這方面,最近有一項重大進展需要分享。11月1日起,加州最大的州醫療補助計畫Medi-Cal將開始為加州成員提供全基因組檢測。我們讚賞他們決定成為美國第 36 個將外顯子組和基因組檢測納入門診服務的州。

  • As I mentioned on our last call, when we begin to sell into new call points and for new indications, we inherently expect lower initial payment rates compared to our established channels like Neuro and Genetics. With this strategy to expand into new markets, some new volume may start out at lower collection rates, which in turn may have a modest impact on our average reimbursement rate in the coming quarters.

    正如我在上次電話會議中提到的,當我們開始向新的客戶點和新的適應症銷售產品時,我們自然會預期初始付款率會比我們已建立的管道(如神經和遺傳學)要低。透過這種拓展新市場的策略,一些新的業務量可能會在初期出現較低的收款率,這反過來可能會對我們未來幾季的平均報銷率產生輕微的影響。

  • That said, any impact should be transitory. And to be clear, unit economics matter to us. Lessons from this industry's past are always top of mind when contemplating pricing and go-to-market strategies. Our view that rates will be durable and enable both high growth and attractive gross margins well into the future remains intact.

    也就是說,任何影響都應該是暫時的。需要明確的是,單位經濟效益對我們來說很重要。在考慮定價和市場推廣策略時,始終要牢記該行業過去的經驗教訓。我們仍然堅持認為,利率將保持穩定,並能在未來很長一段時間內實現高成長和可觀的毛利率。

  • Turning to gross margin. We expanded total company adjusted gross margin of 74%, driven by favorable mix shift, improved reimbursement, and lower COGS. Bryan's team continues to innovate, and they have an impressive road map to further reduce COGS by leveraging automation and AI to optimize production. GeneDx has achieved an important economy of scale advantage, and we expect to hold on to that advantage well into the future.

    接下來我們來看毛利率。由於有利的產品組合調整、報銷政策改善和銷售成本降低,公司整體調整後毛利率成長至 74%。Bryan 的團隊不斷創新,他們制定了令人印象深刻的路線圖,透過利用自動化和人工智慧來優化生產,從而進一步降低銷售成本。GeneDx 已經取得了重要的規模經濟優勢,我們預計在未來很長一段時間內都能保持這一優勢。

  • Adjusted total operating expenses were $71 million.That is up sequentially in terms of aggregate dollars, representing some variable costs growing with the revenue base, but primarily early investments we expect will drive volume growth mid-2026 and beyond. Total OpEx was 61% of revenue this quarter, and that's a number I'm quite comfortable with at this point.

    經調整後的總營運支出為 7,100 萬美元。以總額計算,這比上一輪有所增長,其中一部分可變成本隨收入基礎的增長而增加,但主要是早期投資,我們預計這些投資將在 2026 年年中及以後推動銷量增長。本季總營運支出佔營收的 61%,目前我對這個數字相當滿意。

  • I want to underscore the spend here is deliberate, representing strategic investments into accelerating our long-term growth vectors. Specifically, we've begun to build the first phase of the dedicated GenP sales team. We've added the first few sales heads in new specialty markets and key international markets. We're executing against our first ever brand campaign. We've ramped product and technology talent to design and build our next-gen customer experience for nonexperts and R&D includes innovation to our genomics program and support for clinical and health economic research as just some examples. The expense ramp reflects continued confidence in the ROI. They're all designed to drive volume in the future.

    我想強調,這裡的支出是經過深思熟慮的,代表著對加速我們長期成長方向的策略投資。具體來說,我們已經開始組建第一階段的 GenP 專屬銷售團隊。我們已在新興專業市場和重點國際市場增設了首批銷售主管。我們正在執行我們有史以來的第一個品牌推廣活動。我們已增加產品和技術人才的投入,為非專業人士設計和建構下一代客戶體驗;研發工作包括基因組學計畫的創新以及對臨床和衛生經濟研究的支持,這只是其中的一些例子。支出成長反映了對投資報酬率的持續信心。它們的設計目的都是為了在未來推動銷售成長。

  • That growth, in turn, accelerates a flywheel effect, whereby our Infinity data set expands, our competitive moat strengthens, we attract new customers and economies of scale continue to improve. While these investments impact near-term operating margin, every dollar is meant to build high-quality, durable future revenues.

    這種成長反過來又加速了飛輪效應,從而擴大了我們的 Infinity 資料集,增強了我們的競爭優勢,吸引了新客戶,規模經濟效益也持續提高。雖然這些投資會影響近期的營業利潤率,但每一美元都是為了創造高品質、可持續的未來收入。

  • Expect sequential growth in our operating expense for the next several quarters, but all within a framework designed to achieve industry-leading growth rates while maintaining attractive gross margins. We have demonstrated the ability to drive operating leverage and EPS accretion. With strong demand in an ever-expanding serviceable market, we'll be reinvesting back into the business to capture an exponentially larger future and build long-term value creation. The team here has the experience to understand our responsibility to be good stewards of investor capital.

    預計未來幾季我們的營運費用將逐週成長,但這一切都將在旨在實現行業領先成長率並保持具有吸引力的毛利率的框架內進行。我們已經證明了我們有能力提高營運槓桿和每股盈餘。在服務市場不斷擴大、需求強勁的情況下,我們將把資金再投資於業務,以掌握未來指數級成長的機遇,並創造長期價值。我們團隊擁有豐富的經驗,能夠理解我們身為投資者資金管理者的責任。

  • On the bottom line, we generated $14.7 million in adjusted net income and $0.51 of adjusted basic EPS in the third quarter of 2025. And we're well capitalized with cash, cash equivalents, marketable securities, and restricted cash totaling $156 million as of September 30, 2025. Cash flow for the third quarter included $9 million in free cash flow generated and $12 million in ATM proceeds net of fees from the issuance of 101,367 shares of common stock.

    最終,我們在 2025 年第三季實現了 1,470 萬美元的調整後淨收入和 0.51 美元的調整後基本每股收益。截至 2025 年 9 月 30 日,我們擁有充足的現金、現金等價物、有價證券和受限現金,總額達 1.56 億美元。第三季現金流包括產生的 900 萬美元自由現金流和發行 101367 股普通股扣除費用後的 ATM 收益 1200 萬美元。

  • Now an update on guidance before turning over to Bryan. We're raising top line total revenue guidance to between $425 million and $428 million for full year 2025. Just as a reminder, in the third quarter, we discontinued our hereditary cancer offerings. That business generated $1.2 million in this third quarter of 2025 and $3.3 million in the same quarter last year. It will be near zero in the fourth quarter of this year.

    現在先更新一下指導意見,然後再交給布萊恩。我們將 2025 年全年總營收預期上調至 4.25 億美元至 4.28 億美元之間。再次提醒大家,我們在第三季停止了遺傳性癌症相關產品的銷售。該業務在 2025 年第三季創造了 120 萬美元的收入,而去年同期則創造了 330 萬美元的收入。今年第四季將接近零。

  • We're raising exome and genome revenue guidance to deliver between 53% and 55% growth for full year 2025, which is exome and genome revenues of $358 million to $361 million. As a reminder, when looking at the prior year comp, the fourth quarter of 2024 included a discrete benefit of $6.8 million we called out on our fourth quarter 2024 call. $5.8 million of that benefit was exome and genome. Excluding that, the full year growth rate is 57% to 60%.

    我們將外顯子組和基因組收入預期提高至 2025 年全年增長 53% 至 55%,即外顯子組和基因組收入達到 3.58 億美元至 3.61 億美元。再次提醒,在回顧上年同期業績時,2024 年第四季包含一項 680 萬美元的獨立收益,我們在 2024 年第四季電話會議上已提及。其中 580 萬美元收益來自外顯子組和基因組定序。排除此因素,全年成長率為 57% 至 60%。

  • We again reaffirm our expectation to deliver at least 30% exome and genome volume growth for full year 2025. As had always been expected, volume growth has accelerated throughout the year, and the guide implies a fourth quarter exit of at least 34%. We're raising expectation for full year 2025 adjusted gross margin to between 70% and 71%. And we once again reaffirm our expectation to remain profitable.

    我們再次重申,我們預計到 2025 年全年,外顯子組和基因組的體積將增加至少 30%。正如預期的那樣,銷量成長在全年加速,該指南暗示第四季度末銷量至少增長 34%。我們將 2025 年全年調整後毛利率預期上調至 70% 至 71% 之間。我們再次重申,我們預期將繼續保持獲利。

  • I'll now hand it over to Bryan, our Chief Operating Officer.

    現在我將把發言權交給我們的營運長布萊恩。

  • Bryan Dechairo - Chief Operating Officer

    Bryan Dechairo - Chief Operating Officer

  • Thanks, Kevin. Good morning, everyone. When children need medical care, parents like myself want an accurate diagnosis as soon as possible. That's what we do every single day at GeneDx, and we do it better than any other lab in the world because of GeneDx Infinity, the leading rare disease data set, made up of more than 2.5 million rare genetic tests, including nearly 1 million exomes and genomes and over 7 million phenotypic data points.

    謝謝你,凱文。各位早安。當孩子需要就醫時,像我這樣的家長都希望能盡快得到準確的診斷。這就是我們在 GeneDx 每天都在做的事情,而且由於 GeneDx Infinity(領先的罕見疾病數據集,由超過 250 萬個罕見基因檢測組成,包括近 100 萬個外顯子組和基因組以及超過 700 萬個表型數據點),我們比世界上任何其他實驗室都做得更好。

  • Infinity contains an unparalleled vast and structured reservoir of potential gene variants that cause rare condition. We reported over 25,000 cases this quarter and nearly two-thirds of those were parent-child Trios capturing mom and dad as comparator samples. That means this quarter alone, we actually sequenced more than 55,000 individuals. The scale of the data is fundamental. It takes at least two children with the same gene variation to validate a diagnosis for both kids and the greatest chance of finding another child with fewer child variant is within GeneDx Infinity.

    Infinity 擁有無與倫比的龐大且結構化的潛在基因變異庫,這些變異會導致罕見疾病。本季我們報告了超過 25,000 例病例,其中近三分之二是親子三人組,以父母作為對照樣本。這意味著僅本季度,我們就對超過 55,000 人進行了基因定序。數據規模至關重要。要驗證兩個孩子的診斷,至少需要兩個具有相同基因變異的孩子,而找到另一個基因變異較少的孩子的最佳機會就在 GeneDx Infinity 中。

  • Every patient enriches Infinity's data density, creating the flywheel effect and rapidly making it more difficult for competitors to catch up to our quality, speed, and accuracy across diverse populations. As we're accelerating, this year alone, we are projected to add 30% more rare disease exomes and genomes into Infinity than in the previous 24 years combined.

    每位患者都豐富了 Infinity 的數據密度,從而產生了飛輪效應,並迅速使競爭對手更難趕上我們在不同人群中的質量、速度和準確性。隨著我們加速推進,僅今年一年,我們預計在 Infinity 中添加的罕見疾病外顯子組和基因組數量將比過去 24 年的總和還要多 30%。

  • Tapping into Infinity is our brilliant team of more than 100 MDs and PhDs and 150 genetic counselors who transform Infinity into clear trusted answers that clinicians can act on with confidence. We are also applying AI tools like our ML-powered GeneRanker Multiscore on top of GeneDx Infinity to harness the power of our data, scale our platform, and increase speed and turnaround time.

    挖掘無限潛力,需要我們由 100 多名醫學博士和哲學博士以及 150 名遺傳諮詢師組成的傑出團隊,他們將無限潛力轉化為清晰可信的答案,讓臨床醫生能夠充滿信心地採取行動。我們也利用人工智慧工具,例如我們基於機器學習的 GeneRanker Multiscore,在 GeneDx Infinity 之上應用人工智慧工具,以利用我們數據的力量,擴展我們的平台,並提高速度和周轉時間。

  • We already deliver answers in as soon as 48 hours in critical care settings like the NICU. But by expanding AI across our system, there's potential to turn our ultrarapid turnaround time into standard of care in every setting. Infinity, our team and our technology have helped us build a best-in-class genome, and we continue to raise the bar. We are constantly enriching our product with new genomic technologies, including medium and long-read sequencing and adding multimodal analysis beyond DNA.

    在新生兒加護病房等危重症監護環境中,我們已經能夠在 48 小時內提供解決方案。但是,透過在整個系統中推廣人工智慧,我們有可能將超快速的周轉時間變成各種環境下的標準護理。Infinity、我們的團隊和技術幫助我們建立了一流的基因組,我們將繼續提高標準。我們不斷利用新的基因組技術來豐富我們的產品,包括中長讀長定序,並增加 DNA 以外的多模態分析。

  • Partners come to GeneDx looking to validate emerging technologies and pioneer modalities that will forever change how we diagnose disease, thus creating a virtuous cycle of innovation that not only future-proofs our product leadership, but enhances our ability to serve more patients with speed, accuracy and scale over time. As showcased in the science we delivered at the ASHG conference, these programs generate data that compounds upon our massive library of more than 1,000 peer-reviewed publications, further exemplifying GeneDx position at the forefront of genomic innovation.

    合作夥伴來到 GeneDx,希望驗證新興技術和開創性療法,這些療法將永遠改變我們診斷疾病的方式,從而創造一個良性創新循環,這不僅能確保我們未來的產品領先地位,還能隨著時間的推移,增強我們為更多患者提供更快、更準確、更大規模服務的能力。正如我們在 ASHG 大會上展示的科學成果所表明的那樣,這些計畫產生的數據不斷豐富著我們超過 1000 篇同行評審出版物的龐大資料庫,進一步體現了 GeneDx 在基因組創新領域的前沿地位。

  • In parallel, we are radically simplifying genomics to enable broad adoption in everyday medicine. GeneDx is the number one genetic testing brand amongst pediatric providers, and we are evolving our customer experience to extend that lead. On average, general pediatricians have only 10 minutes with the patient. So we need to meet them where they are with one minute ordering and best-in-class customer experience.

    同時,我們正在從根本上簡化基因組學,使其能夠在日常醫療中廣泛應用。GeneDx 是兒科醫療機構中排名第一的基因檢測品牌,我們正在不斷改進客戶體驗,以擴大這一領先優勢。平均而言,兒科醫生只有 10 分鐘的時間與患者溝通。因此,我們需要在他們需要的地方滿足他們的需求,提供一分鐘下單和一流的客戶體驗。

  • Catalyzed by the American Academy of Pediatrics clinical report in June, we are simplifying ordering and result interpretation for clinicians while enriching the patient and family experience. We are already still testing many of these customer experience innovations and are positioned for broader rollout in 2026 and beyond.

    受美國兒科學會 6 月發布的臨床報告的推動,我們正在簡化臨床醫生的訂購流程和結果解讀,同時豐富患者及其家屬的體驗。我們目前仍在測試許多此類客戶體驗創新,並已準備好在 2026 年及以後更廣泛地推廣這些創新。

  • With that, I'll hand it back to Katherine.

    說完,我就把它還給凱瑟琳。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Thank you so much, Bryan. We talk about being a fast growth business and volumes because each one of those samples represents a family that is desperate for an accurate diagnosis. So we act with urgency and purpose because those patients and families are counting on us.

    非常感謝你,布萊恩。我們談論的是快速成長的業務和銷量,因為每個樣本都代表著一個渴望準確診斷的家庭。因此,我們必須迅速而有目的地採取行動,因為那些病人和他們的家人都指望著我們。

  • There are incredible opportunities ahead as we continue the broader paradigm shift already underway across healthcare, supported by GeneDx Infinity, and strengthened by our network of partners. GeneDx is leading the shift to proactive personalized care that begins at first, unlocking earlier diagnoses, faster breakthroughs and healthier lives for all, and we're very proud of the work we do each and every day. So thank you.

    隨著我們在 GeneDx Infinity 的支持下,以及在我們合作夥伴網路的加強下,醫療保健領域正在進行的更廣泛的範式轉變仍在繼續,未來將出現令人難以置信的機會。GeneDx 引領著主動式個人化照護的變革,從最初階段就開始,從而實現更早的診斷、更快的突破和更健康的生活,我們為我們每天所做的工作感到非常自豪。所以,謝謝你。

  • With that, I'd love to open up the line for your questions.

    那麼,我很樂意接受大家的提問。

  • Operator

    Operator

  • (Operator Instructions) Subbu Nambi, Guggenheim.

    (操作員指示)Subbu Nambi,古根漢。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • With emphasis at AAP for clinicians to take a stepwise approach to ordering beginning with chromosomal microarray, have you seen an uptick in volume there? And if so, how does that change your strategy, if at all, to sunset some of these legacy products?

    美國兒科學會 (AAP) 強調臨床醫生應採取循序漸進的方法進行檢測,首先進行染色體微陣列檢測,您是否注意到檢測量增加?如果是這樣,那麼在逐步淘汰這些老舊產品方面,你們的策略會發生怎樣的變化(如果有的話)?

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Absolutely. Thanks, Subbu. As I mentioned in the script, most pediatricians are hearing about the guidelines update for the first time from us. So whether it is at AAP or as we're starting to engage with pediatricians on education, they're hearing about it from us.

    絕對地。謝謝,Subbu。正如我在腳本中提到的,大多數兒科醫生都是第一次從我們這裡了解指南的更新。所以,無論是在美國兒科學會 (AAP) 上,還是在我們開始與兒科醫生進行教育交流時,他們都會從我們這裡了解到這些資訊。

  • So I think that underscores the massive need for education and why it reaffirms our view that it will take 18 to 24 months beyond education, it's also going to require workflow. So I would say what we saw in the quarter was the vast majority of growth coming from our core, which is great. And no meaningful uptake in terms of orders from pediatricians from CMA and no notable changes on CMA or orders from general peds. But really good engagement.

    所以我認為這凸顯了教育的巨大必要性,也再次印證了我們的觀點,即除了教育之外,還需要 18 到 24 個月的時間,還需要工作流程。所以我認為,本季我們看到的大部分成長都來自我們的核心業務,這非常好。兒科醫生對 CMA 的訂單沒有實質的採納,CMA 或普通兒科醫生的訂單也沒有明顯變化。但互動效果真的很好。

  • I would say the research that we've done with pediatricians is affirming how important our opportunity is. And it's not if they're going to order an exome or a genome, it's how they're going to order it. And is it going to be through an improved ordering process that we're building that Bryan talked about. So one minute ordering, we think, is an awesome improvement for us as we think about 2026.

    我認為我們與兒科醫生共同進行的研究證實了我們所獲得的機會有多麼重要。問題不在於他們是否會訂購外顯子組或基因組,而是他們將如何訂購。而這是否會透過我們正在建構的、布萊恩提到的改進訂購流程來實現呢?因此,我們認為,一分鐘下單服務對我們來說是一項了不起的進步,尤其是在展望 2026 年的時候。

  • Doctors are consumers, too. And so they're used to fast efficient ordering. And Epic Aura is also going to be a great way. So I would say that the feedback that we're getting from the engagement that we're having with pediatricians is really positive about the fact that they are going to order testing and want to order it from us. I think the FDA designation only further reinforces why they should order from us.

    醫生也是消費者。因此,他們習慣了快速且有效率的訂購方式。史詩光環也將是一個很棒的途徑。因此,我認為我們從與兒科醫生的互動中得到的回饋非常積極,他們表示會訂購檢測服務,並希望從我們這裡訂購。我認為FDA的認證進一步強化了他們應該向我們訂購產品的理由。

  • Infinity is another reason why they're going to order from us in terms of accuracy. So it's not -- if they're going to order, it's how, and we feel really confident it will be from GeneDx.

    就精確度而言,Infinity 是他們選擇向我們訂購的另一個原因。所以問題不在於——如果他們要訂購,那就是如何訂購,我們非常有信心他們會從 GeneDx 訂購。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • Kevin, this one is for you. The guide implies ASPs to go down sequentially. Is that just conservatism? Or are there any seasonal dynamics to call out? Even the margin guide implies COGS to increase sequentially?

    凱文,這是給你的。該指南暗示平均售價會依序下降。那隻是保守主義嗎?或者說,是否存在需要特別指出的季節性變化?即使是利潤率指引也暗示銷售成本會逐期增加?

  • Any color you could provide -- and then just a cleanup, the true-ups for 3Q '24, in this print, it says $2.2 million, but in the Q, it had said $6.3 million, if I remember it right. So just help us out here, please.

    任何顏色都可以提供——然後只是進行一些清理,對 2024 年第三季度的數據進行修正,在這份印刷品中,它顯示為 220 萬美元,但如果我沒記錯的話,在季度報告中,它顯示為 630 萬美元。所以,請幫我們一把吧。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yes. And by the way, in case I misspoke in my prepared remarks, the third quarter average reimbursement rate was over $3,800 and so representative of a lot of strength in the third quarter and continually reducing denials. So really pleased with that third quarter result over $3,800. Yes, the guide would imply that potentially the rate could bounce around some in the magnitude of about $100 down in the fourth quarter. That's really just part of that inherent expectation as we continue to open up new call points, target indication expansion there may be some experience on the outset where rates are artificially lower to start, and we have to build up some experience and show that demand to payers. And so the guide builds in some conservatism in that regard just to level set.

    是的。順便一提,如果我在準備的發言中說錯了什麼,第三季的平均報銷率超過 3800 美元,這代表了第三季強勁的成長勢頭,拒付率也在持續下降。第三季業績超過 3800 美元,我非常滿意。是的,該指南暗示,第四季度利率可能會出現約 100 美元的波動。這其實只是我們不斷開拓新的業務領域、擴大適應症範圍時,必然會遇到的固有預期的一部分。一開始,費率可能會人為地降低,我們需要累積一些經驗,向支付方證明這種需求。因此,該指南在這方面採取了一些保守做法,以保持平衡。

  • And then in terms of true-ups throughout the year, the third quarter, nothing to call out, very minimal impact in terms of out-of-period adjustments in the third quarter. So that rate of over $3,800 is representative of what we think the third quarter activity will produce. And historically, we've averaged a couple of million dollars of those true-ups each quarter, but nothing that I would call out as extraordinary or onetime.

    至於全年的調整,第三季沒有特別需要指出的,第三季非當期調整的影響非常小。因此,超過 3800 美元的成長率代表了我們認為第三季活動將產生的水平。從歷史上看,我們每季平均都會進行數百萬美元的此類調整,但沒有什麼特別之處或一次性的。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • And Kevin, it was a pretty good margin as well this quarter. So is there any reason for us to believe that it should not be sustainable?

    凱文,這季的利潤率也相當不錯。那麼,我們有什麼理由認為這種做法不可持續呢?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • No. Look, we raised the guide again in terms of gross margin. And so I just wanted to leave some room there should we see some of those reimbursement rates bounce around some in the fourth quarter. So a little bit of a function of raising the guide but keeping a bit of a conservative stance.

    不。你看,我們又提高了毛利率指導目標。因此,我只是想留出一些空間,以防我們在第四季度看到一些報銷率出現波動。所以,這在某種程度上是提高指導方針,但同時保持一定保守立場的一種方式。

  • Operator

    Operator

  • Dan Brennan, TD Cowen.

    丹·布倫南,TD Cowen。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Maybe the first one, Kevin and Katherine, can you just speak to the NICU? I know you discussed, Katherine, in your prepared remarks, you guys are on track for the number of NICUs that are be enabled with EMR. But just kind of what did you see in Q3? How do we think about implicit in the volume guide for 4Q, what the NICU contribution is? And any color on just kind of what some of the early traction and kind of feedback has been?

    凱文和凱瑟琳,你們能不能先跟新生兒加護病房那邊說?我知道凱瑟琳,你在事先準備好的演講稿中提到過,你們正在按計畫為新生兒加護病房配備電子病歷系統。但你對第三季的情況有什麼看法?我們如何看待第四季度產量指南中隱含的新生兒加護病房 (NICU) 的貢獻?那麼,能否透露一下早期的一些進展和回饋?

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Yes, I'll start, and then we'll pass it over to Kevin. So the NICU, as I said, remains a really important opportunity. It is shocking to people when you say fewer than 5% of babies in the NICU get a genetic test. We have the clinical data. We've got the health economic data.

    好的,我先開始,然後交給凱文。所以,正如我所說,新生兒加護病房仍然是一個非常重要的機會。當你說新生兒加護病房裡只有不到 5% 的嬰兒接受基因檢測時,人們會感到震驚。我們有臨床數據。我們已經掌握了衛生經濟數據。

  • We have the calculator that can convince the CFO that this is going to be good for their business. Hospitals are running businesses as well. And we have Epic Aura.

    我們有一個計算器,可以說服財務官,這樣做對他們的業務有好處。醫院也是在經營生意。我們還有史詩光環。

  • We're continuing to see growth in that sector. And in fact, that it's a fast-growing part of our business. We're seeing meaningful growth in terms of same-store sales on the NICU side of things. So we definitely see it as an important contributor to our overall goal of getting an earlier possible diagnosis.

    我們看到該領域持續成長。事實上,這是我們業務中成長最快的部分。我們看到新生兒加護病房 (NICU) 的同店銷售額出現了顯著成長。因此,我們絕對認為它是實現儘早診斷這一總體目標的重要因素。

  • And what we're also learning is that some clinicians like our portal. And so we're on track to continue to drive Epic Aura. We'll have at least 12 systems activated by the end of this year. We're seeing kind of the full test menu being ordered, which is fantastic. So we think Epic Aura continues to be a meaningful unlock for new clinicians who are working with us.

    我們也了解到,有些臨床醫生喜歡我們的門戶網站。因此,我們正按計劃繼續推進 Epic Aura 專案。到今年年底,我們將至少啟用 12 個系統。我們看到幾乎所有人都點了完整的測試菜單,這真是太棒了。因此,我們認為 Epic Aura 對於與我們合作的新臨床醫生來說,仍然是一個意義重大的解鎖工具。

  • And so we're going to continue to drive utilization of Epic Aura at the health system level in order to impact both outpatient and inpatient.

    因此,我們將繼續在醫療系統層面推動 Epic Aura 的使用,從而對門診和住院治療產生影響。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yes. I mean through the third quarter and to date, volumes from the MU are growing nicely. It's one of our fastest-growing channels, albeit from a much smaller pace. But percentage-wise, it's growing nicely. Throughout the year, we've been tracking looking to bring in an incremental 2,000 units or so in the second half of the year with most of those coming in the fourth quarter.

    是的。我的意思是,從第三季至今,MU 的銷售量成長良好。雖然增速較慢,但它是我們成長最快的管道之一。但從百分比來看,它的成長勢頭良好。今年以來,我們一直致力於在下半年新增約 2,000 台的銷量,其中大部分將在第四季度實現。

  • We're going to run through the tape as much as we can through the fourth quarter. Whether or not we hit that number exact or not, more than confident that outpatient volumes will supplement and more than make up for that. I think most importantly, we're seeing growth. We're engaging with health system administrators and our thesis that the NICU market is very compelling and part of our growth story in the years to come remains very much intact.

    在第四節比賽期間,我們會盡可能回看錄影。無論我們是否能準確達到這個數字,我都非常有信心門診量將彌補這一缺口,甚至綽綽有餘。我認為最重要的是,我們看到了成長。我們正在與醫療系統管理人員進行溝通,我們關於新生兒重症監護室市場非常有吸引力,並且是我們未來幾年增長計劃的一部分的論點仍然完全成立。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Maybe just on the quarter itself. I mean the quarter came in better than expected. I know in past quarters, you've given some color about same-store sales growth, maybe some new indications. I know you discussed in the prepared remarks also new doctors. Just any way to frame kind of what's happening with their volumes and how that might inform kind of the implied guide for the fourth quarter with those building blocks?

    或許只是硬幣本身。我的意思是,本季業績比預期要好。我知道在過去的幾個季度裡,您已經對同店銷售成長進行了一些說明,或許還有一些新的跡象。我知道您在準備好的演講稿中也談到了新醫生。有沒有什麼方法可以概括一下他們的銷售變化情況,以及這些變化如何影響第四季度的預期走勢?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • The strength really driven by those core outpatient markets, continued nice step-up from even that innermost core of Expert Geneticist. So we are seeing strong signals of the continued evolution of those docs putting down single-gene tests and multi-gene panels in place of exome and genome, and we'd expect that to continue for several more quarters or years to come. So in terms of same-store sales rates at Expert Geneticist continue to see nice uptake there. And then ped neuros good account activation. We're now at a point where just over a third of all ped neuros are ordering their exome and genome from us.

    真正的成長動力來自核心門診市場,即使是專家遺傳學家的核心群體也持續穩定成長。因此,我們看到強烈的跡象表明,越來越多的醫生開始用單基因檢測和多基因檢測來代替外顯子組和基因組檢測,我們預計這種情況還會持續幾個季度或幾年。因此,Expert Geneticist 的同店銷售額持續保持良好成長動能。然後是 ped neuros 良好的帳戶激活。現在,超過三分之一的兒科神經科醫生都向我們訂購了他們的外顯子組和基因組檢測。

  • Not all of those are mature yet in their ramp cycle. And so good growth to come from docs we've already activated. But I think what's more exciting to us in the coming quarters is just the green space to activate more docs there.

    並非所有這些產品都已進入成熟的成長週期。因此,我們已經啟動的文件將會帶來良好的成長。但我認為在接下來的幾個季度裡,更讓我們興奮的是,我們可以利用這片綠地開展更多的專案。

  • The messaging we have for how we can serve that cohort, in particular, is really resonating. And so the next couple of quarters, we'll continue to see growth rates pretty similar to what we just produced from ped neuro and geneticist. And of course, what we remain most excited about is activating even more call points in the coming quarters.

    我們針對如何服務該群體所傳遞的訊息,尤其引起了他們的共鳴。因此,在接下來的幾個季度裡,我們將繼續看到與兒科神經病學和遺傳學領域剛剛取得的成果非常相似的成長率。當然,我們最興奮的還是在接下來的幾個季度啟動更多的呼叫點。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • And then maybe just one final follow up. I heard you mention on the cost side. I'd love to get a little more color on kind of OpEx. I think you said the third quarter OpEx number is a good number. Maybe you can just elaborate a little bit on the OpEx spending from here.

    最後或許還有最後一個後續問題。我聽你提到了成本方面的問題。我想更詳細地了解一下營運支出(OpEx)方面的資訊。我認為你說過第三季的營運支出數據不錯。或許您可以再詳細闡述營運支出方面的情況。

  • And I think you said it's going to open up growth by mid-'26. So is that when we're expecting to see a bit of like some pediatrician volume show up? So maybe just clarify the OpEx outlook and kind of and the pediatrician call point and the impact there.

    我想你說過,到 2026 年中期,這將帶來成長。所以,我們是不是應該在這個時候看到兒科醫師接診量增加?所以或許應該要明確一下營運支出前景,以及兒科醫師接診點及其影響。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yes. We've begun to build out the commercial team that, of course, includes building a dedicated general pediatrician sales team. I think we remain anchored on that initial expectation we set of about 18 to 24 months from the time those AAP guidelines dropped in June to when we would see sort of escape velocity on incoming volume.

    是的。我們已經開始組建商業團隊,當然包括組建一支專門的兒科醫生銷售團隊。我認為我們仍然堅持最初的預期,即從 AAP 指南在 6 月發佈到我們看到業務量出現某種爆發式增長,大約需要 18 到 24 個月的時間。

  • That said, we're engaging with the pediatrician community as we speak. We attended their conference in September. And all of that has validated our thesis that the market will be real and that there will be demand out there, but we've got to build some of the tools and medical education. And so we'll, of course, be carrying some incremental commercial costs as we go through that education period. And so that's part of the step-up there.

    也就是說,我們正在與兒科醫生群體進行溝通。我們九月參加了他們的會議。所有這些都證實了我們的論點,即市場是真實存在的,而且市場會有需求,但我們必須建立一些工具和醫學教育。因此,在這教育階段,我們當然會承擔一些額外的商業成本。所以,這是提升過程的一部分。

  • And if we look at overall R&D spend, we continue to rev our genomic assays and technology to keep the best-in-class product in the field and build out that customer experience for nonexperts because we continue to see strong ROI opportunities and pulling through volume from even more physician types out there. So the level of step-up from Q2 to Q3, you might expect something similar into the fourth quarter from Q3 to Q4, but all within an eye towards keeping the business profitable. We maintain our commitment to keep the business in the black there so that we can continue to reinvest back into achieving industry-leading growth rates.

    如果我們從整體研發支出來看,我們將繼續改進基因組檢測和技術,以保持業內一流的產品,並為非專業人士打造卓越的客戶體驗,因為我們持續看到強勁的投資回報率機會,並吸引更多不同類型的醫生購買。因此,與第二季到第三季相比,第四季可能會出現類似的成長,但這一切都是為了保持業務獲利。我們將繼續致力於維持當地業務獲利,以便能夠繼續再投資,實現業界領先的成長率。

  • Operator

    Operator

  • Mark Massaro, BTIG.

    馬克·馬薩羅,BTIG。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Congrats on the strong quarter. I wanted to start, you guys indicated, if I heard correctly, that you plan to double the size of your sales force over the coming quarters. Just looking at your website, it looks like there's over 80 job openings and over 35 to 40 in general pediatrics. Can you just give us a sense for how quickly you plan to onboard these folks? I think you indicated that you've added the first few reps. But can you just give us a sense of how large of a team this might look like, say, maybe two years from now?

    恭喜你們本季業績出色。我想先問一下,如果我沒聽錯的話,你們計劃在未來幾季將銷售團隊的規模擴大一倍。僅從你們的網站來看,似乎有超過 80 個職缺,其中有 35 到 40 個是普通兒科醫生職位。您能否大致說明一下您計劃以多快的速度讓這些人加入團隊?我想你之前已經表示完成了最初的幾次重複練習。但您能否大致描述一下,比如說,兩年後,這個團隊可能會有多大?

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Sure. So we have started hiring our regional sales directors. So the leaders who are coming in and who are starting to form their teams. Frankly, there's just really good talent available to us on the market right now, and we wanted to make sure that we're hiring the best of the best. And I'm thrilled to see the talent that's coming in at the RSD level.

    當然。所以我們已經開始招募區域銷售總監了。所以,那些上任的領導者們正在開始組建他們的團隊。坦白說,目前市面上有許多優秀的人才,我們希望確保招募到最優秀的人才。我很高興看到RSD等級湧現這麼多優秀人才。

  • So we expect that we're going to be -- as the regional sales directors get assembled, we want to make sure that they are discerning and recruiting the best. So I expect over the next several quarters, we'll get them up to in their seats and activated.

    因此,我們希望-隨著區域銷售總監的組成,確保他們能夠慧眼識珠,招募到最優秀的人才。所以我預計在接下來的幾個季度裡,我們會讓他們回到崗位並投入工作。

  • And then, of course, it requires training and ensuring that they have their merchant orders in the field. So we've said about double the size of the sales force today. And so we'll be opportunistic and continue to hire over the next several quarters. Our goal is to accelerate that adoption framework. We said 18 to 24 months.

    當然,還需要進行培訓,並確保他們在現場能夠收到商家的訂單。所以我們說過,銷售團隊的規模大約是現在的兩倍。因此,我們將抓住機會,在接下來的幾季繼續招募。我們的目標是加快這項框架的採納。我們說需要18到24個月。

  • We still think that, that's accurate. But of course, we're going to push to see if we can pull that in as much as we can and all centers around that North Star of earliest possible diagnosis for as many families as possible. So we're hiring.

    我們仍然認為這是準確的。當然,我們會盡一切努力,看看能否盡可能地實現這一點,所有工作都圍繞著一個核心目標:為盡可能多的家庭儘早做出診斷。所以我們正在招募。

  • I think looking at two years from now, could we grow beyond that? Possibly, but we first need to see. I'd like to get this team assembled. I'd like to have them activated. We want to get the features up and running in terms of the workflow.

    我認為展望兩年後,我們能否有更大的發展?有可能,但我們首先需要看看。我想把這個團隊組起來。我希望它們能夠被啟動。我們希望在工作流程方面讓這些功能正常運作。

  • We know it's going to require more education, more medical affairs education. So we have a lot of work to do. So I wouldn't want to commit to building the team beyond what we've built or beyond what we're hiring for today because I think that's a really healthy investment in forward leaning growth. So hopefully, that gives you a sense of how we're thinking about it.

    我們知道這需要更多的教育,更多的醫學事務教育。所以我們還有很多工作要做。所以我不想承諾在現有團隊規模或我們目前招募規模之外再去擴充團隊,因為我認為這是對未來發展的一種非常健康的投資。希望這能讓您了解我們的想法。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Yes, that's great. And I wanted to ask, congrats on all the progress on the newborn side with the Florida Sunshine Genetics Act, the BEACONS NIH award and the ongoing GUARDIAN study. Recognizing this is a ways away in terms of recognizing, I would say, perhaps clinical revenue. But can you give us a sense for whether or not you think that this could be more of a near-term driver as it relates to driving clinical adoption.

    是的,那太好了。我想祝賀你們在新生兒領域取得的所有進展,包括佛羅裡達陽光遺傳學法案、BEACONS NIH 獎以及正在進行的 GUARDIAN 研究。就認識到這一點而言,我認為,或許距離認識到臨床收入還有一段路要走。但您能否談談您是否認為這會是推動臨床應用的近期驅動因素?

  • So I guess what I'm asking is in -- like first half of '26, would you expect to drive any clinical testing in genetic newborn screening? Or would this all be basically precursor work to create the evidence for this in the out years?

    所以我想問的是——例如在 2026 年上半年,您是否預計會推動新生兒基因篩檢的任何臨床試驗?或者這一切基本上都是為了在未來幾年累積證據而做的前期工作?

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Yes. So thank you for recognizing that we have been central to all of these studies. And these have all been competitive processes. And we have put our best foot forward with each of them. I think the reason why we continue to be selected is because we've done more of this than anyone in the United States.

    是的。感謝您認可我們在所有這些研究中所扮演的核心角色。這些都是競爭性的過程。我們已盡全力做好每一件事。我認為我們之所以能不斷被選中,是因為我們在這方面做得比美國任何人都多。

  • And now with Fabric, it certainly extends our opportunity to be able to do it in a standardized way regardless of if a baby is born in Los Angeles or London. Every child deserves results that are coming from the same data set, which is Infinity. So we think that we've got a massive opportunity to be able to really lead this new era of genomic medicine. Just to give you a little bit of color on each of these programs.

    現在有了 Fabric,無論嬰兒出生在洛杉磯還是倫敦,我們都能以標準化的方式進行操作,這無疑擴展了我們的機會。每個孩子都應該得到來自同一資料集(即無限)的結果。因此,我們認為我們擁有巨大的機會,能夠真正引領基因組醫學的新時代。簡單介紹一下這些項目。

  • So obviously, with GUARDIAN, it established, I think, a responsible ethical foundation for why you can do newborn screening in a way that is going to be something that parents have demand for, 70% of parents enrolled and to be able to deliver clinically actionable information, more than 3% of babies had a clinically actionable finding.

    顯然,GUARDIAN 計畫為新生兒篩檢奠定了負責任的倫理基礎,我認為,這是父母所期望的,70% 的父母參與了篩檢,並且能夠提供具有臨床意義的信息,超過 3% 的嬰兒有具有臨床意義的發現。

  • With BEACONS, which is an NIH grant, that is looking at a federal approach to how do we operationalize it. And so we're going to be gaining more and more information on how to do this in a more standardized way across multiple states. So there's inherent goodness, I think, in that. And then, of course, Sunshine really takes it out of a research setting and into the clinic. So each one of those has an important -- is playing an important role in how we get to a place where we can drive clinical samples and start getting paid for them, which is ultimately what we want to accelerate.

    BEACONS 是美國國立衛生研究院 (NIH) 的一項撥款,它正在研究如何以聯邦方式實施該計劃。因此,我們將獲得越來越多的信息,了解如何在多個州以更標準化的方式進行這項工作。所以我認為這其中蘊含著內在的善意。當然,Sunshine 真正將這項研究從研究環境帶入了臨床實踐。因此,每一項都發揮著重要的作用,幫助我們實現臨床樣本的取得和付費,而這正是我們最終想要加速實現的目標。

  • I would say the one piece that we have yet to deliver on, but that we are working on with the various groups that are overseeing the steering committees of these programs is the health economics. We think that's going to be a critically important part of how we can actually start getting paid for it.

    我認為我們尚未完成,但正在與負責這些計畫指導委員會的各個團體共同努力完成的一項工作是衛生經濟學。我們認為這將是我們真正開始獲得報酬的關鍵。

  • But as we talk to state Medicaid, we're talking about outpatient health economics. We're talking about inpatient health economics, and we're talking about newborn screening and why they need to start paying attention to it. So I think Florida gives us the first opportunity to say that there is a state that has a progressive approach to genomics and child health.

    但是,當我們與州醫療補助計劃交談時,我們談論的是門診醫療經濟學。我們正在討論住院醫療經濟學,我們也正在討論新生兒篩檢以及為什麼他們需要開始關注它。所以我認為佛羅裡達州給了我們第一個機會,讓我們能夠說,有一個州在基因組學和兒童健康方面採取了進步的方法。

  • And we want to continue to drive kind of the competition across these other states in order to start getting paid for it. We don't anticipate that, that's going to be a '26 driver in terms of revenue. But we'd like to see how we can continue to accelerate some of these policies to get paid as soon as possible.

    我們希望繼續推動其他州之間的競爭,以便開始從中獲得收益。我們預計不會出現這種情況,這將是 2026 年營收成長的驅動因素。但我們希望看看如何才能繼續加快其中一些政策的實施,以便盡快獲得報酬。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yes. I think the base plan, Mark, not counting on anything material in '26, and we'll have further updates throughout 2026 and what that means to 2027 and beyond. But certainly, the momentum would say that beginning in '27 and beyond, we may start to see some nice contribution there.

    是的。我認為基本計劃是,馬克,不指望 2026 年發生任何實質性的事情,我們將在 2026 年全年進行進一步更新,並說明這對 2027 年及以後意味著什麼。但可以肯定的是,從 2027 年及以後,我們可能會開始看到這方面取得一些不錯的成績。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Okay. Fantastic. And then if I can ask one more. I am curious about the FDA path. Nice to see breakthrough device designation come in from the agency. Can you give us a sense for timing here?

    好的。極好的。如果我能再問一個問題的話。我對FDA的審批流程很有興趣。很高興看到該機構授予突破性醫療器材認定。您能大概說說時間安排嗎?

  • Are you expecting to have to run any more clinical trial work or samples to prove the evidence to obtain the approval? And I recognize that some clinicians sort of like the stamp of approval from the agency, but there could potentially be pricing or ADLT implications here. So can you just maybe walk us through the rationale to pursue FDA approval?

    您是否預計需要進行更多臨床試驗或採集更多樣本來證明獲得批准所需的證據?我知道有些臨床醫生喜歡得到該機構的認可,但這可能會對定價或 ADLT 產生影響。那麼,您能否為我們解釋一下尋求 FDA 批准的理由?

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Sure. I'll kick it off and then I'll (technical difficulty) over to Bryan, who's been leading the charge here. So part of the rationale as we think about the future market, I think a couple of things. One, your point about, yes, clinicians do respond to FDA and FDA-approved, FDA authorized and see it as a sign of validation. And pediatricians who are really busy looking at everything under the sun, we know that they also respond to FDA approved FDA authorized.

    當然。我先開始,然後(技術故障)把麥克風交給布萊恩,他一直在這裡帶頭。所以,在思考未來市場時,我認為部分原因有以下幾點。第一,你提到,臨床醫生確實會對 FDA 和 FDA 批准、FDA 授權的產品做出反應,並將其視為一種認可的標誌。兒科醫生忙於研究各種各樣的問題,我們知道他們也會對 FDA 批准或授權的產品做出反應。

  • So we think that there's a really important message to be delivered to accelerate that market. I think part of what's interesting, and this is different than in the oncology space. And as we think about the importance of FDA, in rare diseases, we're trying to open up access and open up more diagnoses, not limit them. So we don't see a real restriction coming through this designation.

    所以我們認為,要加速這個市場的發展,必須傳遞一個非常重要的訊息。我認為有趣的是,這與腫瘤學領域有所不同。當我們思考 FDA 在罕見疾病領域的重要性時,我們努力擴大治療範圍,增加診斷,而不是限制診斷。因此,我們認為這項認定不會帶來真正的限制。

  • But I'll let Bryan comment some more on what the next steps are and how the path will look moving forward.

    但我會讓布萊恩再就下一步計畫以及未來的發展方向發表一些看法。

  • Bryan Dechairo - Chief Operating Officer

    Bryan Dechairo - Chief Operating Officer

  • Thanks, Katherine. Mark, -- so the breakthrough designation is really important because what it actually shows us signals is that our test is unique. The power of our Infinity database is also unique. And it shows that what we're doing today is actually helping critical patients to make decisions that there's nothing else out there to help them with today. And that's what breakthrough designation says from the FDA's recognition.

    謝謝你,凱瑟琳。馬克,——所以突破性稱號非常重要,因為它實際上向我們表明,我們的測試是獨一無二的。我們的 Infinity 資料庫的強大功能也是獨一無二的。這表明,我們今天所做的一切,實際上是在幫助危重病人做出目前其他任何方法都無法幫助他們做出的決定。這就是美國食品藥物管理局(FDA)授予突破性療法認定的意義所在。

  • It also is letting us know that FDA is working side-by-side with us in an accelerated regulatory framework to get this critical technology through the agency and to as many people around the US and globally because FDA is also recognized by many markets around the US as we expand ex-US as well.

    這也讓我們知道,FDA 正在與我們並肩合作,在一個加速監管框架內推進這項關鍵技術通過該機構的審批,並惠及美國乃至全球盡可能多的人,因為 FDA 也得到了美國許多市場的認可,而我們也正在向美國以外的地區擴張。

  • But the nice thing I would also say is not only expedited regulatory review. We are also working by the fact that we've been around for 25 years. Our process, our test is not changing. And what we're doing is we're working with FDA to understand our legacy data and all the power of our database and how it informs the accuracy that we've already been bringing to patients. It's not a new test. It's a test that we've done for many years that we lead in that place.

    但值得一提的是,監管審查速度也很快。我們也利用了我們已經成立25年這一事實。我們的流程和測試方法不會改變。我們正在與 FDA 合作,了解我們的歷史數據和資料庫的全部功能,以及這些數據如何提高我們已經為患者帶來的準確性。這不是一項新測試。這是一項我們已經做了多年的測試,我們在這方面一直處於領先地位。

  • And so I wouldn't look at this at all as limiting access or limiting reimbursement or limiting the actual diseases that we're answering today. It will just be a partnership to accelerate the regulatory review and give that stamp of FDA approval that pediatricians look for in their medications, and they look for that in their diagnostic test as well.

    因此,我完全不認為這是在限制獲取途徑、限制報銷或限制我們今天正在應對的實際疾病。這將是一項旨在加快監管審查並獲得兒科醫生在藥物和診斷測試中都尋求的 FDA 批准的合作。

  • Operator

    Operator

  • Tycho Peterson, Jefferies.

    泰科·彼得森,傑富瑞集團。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • I want to go back to the OpEx questions. I know you've had a few already. I appreciate the color on the sales hires. I guess, Kevin, maybe help us think about the ROI on some of the buckets that you flagged. And I'd love to hear a little bit more color beyond the sales hires, you talked about the first brand campaign, international product and technology investments. Maybe could you bucket those for us how meaningful they are?

    我想回到營運支出方面的問題。我知道你已經喝過幾杯了。我喜歡銷售人員穿著的色彩。我想,凱文,或許你可以幫我們思考一下你提到的那些投資項目的投資報酬率。我很想聽聽除了銷售人員招募之外的更多細節,您談到了第一個品牌推廣活動、國際產品和技術投資。能否幫我們分析這些因素的意義?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yes. In many ways, it's like choosing between your children. They're all really important to create a bit of the virtuous cycle to make us more attractive and more sticky with more and more physician types out there. And so the commercial expansion should be viewed as our confidence in the long-term market well beyond the existing physician types that we have today. We have about three call points today, at least primarily, neuro, geneticist, and then the NICU.

    是的。從很多方面來看,這就像在自己的孩子之間做選擇一樣。它們對於創造良性循環都非常重要,這能讓我們更有吸引力,更能吸引越來越多的醫生群體。因此,商業擴張應該被視為我們對長期市場的信心,這種信心遠遠超出了我們今天所擁有的現有醫生類型。目前我們主要有三個求助點,分別是神經科醫師、遺傳學家和新生兒加護病房。

  • You can see that expanding well beyond a dozen towards 20 over time as you slice different physician types. The largest is the general pediatrician, the 60,000 pediatricians in the US. There's about 25,000 of those who are ordering diagnostic tests for developmental intellectual delay, which is covered by the umbrella of those AAP guidelines. And so that's a lot of doors to knock on, and we intend to do so, bringing the best available experience to those nonexperts.

    你可以看到,隨著你對不同類型的醫生進行細分,醫生人數會從十幾人增加到二十人左右。人數最多的是普通兒科醫生,美國有 6 萬名兒科醫生。大約有 25,000 人正在訂購發育性智力遲緩的診斷測試,這都屬於 AAP 指南的範疇。因此,我們需要敲開很多扇門,而我們也打算這樣做,為那些非專業人士帶來最好的體驗。

  • As Bryan talked about, those are really busy physicians without a lot of face time. And so it's important that we build the experience, both on the front end to honor their time, but also on the back end to make them feel comfort in providing what oftentimes is devastating diagnosis to families. And so GeneDx is one of the largest employers of geneticists and genetic counselors in the country, if not the world. And so part of the long-term road map is to force multiply those resources with technology so that nonexperts are comfortable in providing care to patients in the back end of a diagnostic result.

    正如布萊恩所說,這些醫生工作非常繁忙,沒有太多時間與病人面對面交流。因此,我們必須創造良好的體驗,一方面在前期尊重他們的時間,另一方面在後期讓他們感到安心,以便向家屬提供往往是毀滅性的診斷結果。因此,GeneDx 是全國乃至全世界最大的遺傳學家和遺傳諮詢師雇主之一。因此,長期發展路線圖的一部分是利用技術來倍增這些資源,以便非專業人員能夠在診斷結果出來後,自信地為患者提供護理。

  • All of those, we think, important to capture a leading market share. Today, we hold about an 80% market share of all clinical exome and genome run in the United States, whether we hold 80% or give up a few hundred basis points here or there over the next decade, we'll see, but we intend to hold a majority market share in much larger markets to come. And we think now is the time to make some of those investments.

    我們認為,所有這些對於佔據領先的市場份額都至關重要。目前,我們在美國臨床外顯子組和基因組檢測市場佔有約 80% 的市佔率。未來十年,我們能否維持 80% 的市場份額,或在某些方面失去幾百個基點,我們拭目以待。但我們的目標是在未來更大的市場中佔多數市場。我們認為現在是時候進行一些這樣的投資了。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • The only thing I would add, Tycho, two things. One, whatever we're putting a sales rep out there, we first are following the patients, and we're also following reimbursement. So we're not going to put a rep in a territory, whether it's in the US or in a region outside the US unless there's ample patients for us to help and a healthy path to reimbursement. So those have been like our core principles that I think are unique to GeneDx's business model that we're committed to.

    泰科,我只想補充兩點。第一,無論我們派出銷售代表去做什麼,我們首先要關注患者,其次要關注報銷情況。因此,除非有足夠的病人需要我們幫助,並且有合理的報銷途徑,否則我們不會在一個地區(無論是在美國還是在美國以外的地區)派駐代表。所以,這些就是我們一直以來堅持的核心原則,我認為這些原則是 GeneDx 商業模式獨有的,也是我們始終致力於實現的。

  • Second, on the brand campaign, we are continuing to drive awareness of GeneDx because part of the problem is geneticists have known GeneDx, 8 out of 10 geneticists know us. We need to continue to raise awareness amongst general clinicians as well as parents. So parents know to ask for this testing that the technology exists today is paid for today by insurance companies and that we can get them an answer in a short period of time.

    其次,在品牌推廣活動方面,我們正在繼續提高人們對 GeneDx 的認識,因為部分原因是遺傳學家已經了解 GeneDx,10 位遺傳學家中有 8 位了解我們。我們需要繼續提高普通臨床醫師和家長的認識。所以家長們知道,如果要求進行這項檢測,保險公司會支付目前已有的技術費用,而且我們可以在短時間內給他們一個結果。

  • So we've got a strong effort there that is only being amplified by the addition of Lisa Gurry, who was at Microsoft running marketing across different business units amongst other roles for about 25 years, and she was at Truveta as well. So she's going to help us also really amplify how we communicate the message, both to clinicians and to patients as well.

    因此,我們在這方面投入了大量精力,而 Lisa Gurry 的加入更是錦上添花。 Lisa Gurry 在微軟工作約 25 年,負責不同業務部門的行銷以及其他職務,她也曾在 Truveta 工作過。所以她也將幫助我們真正加強與臨床醫生和患者溝通的方式。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • Okay. Maybe a follow-up along those lines. I guess, CapEx is also up 3x over last year. I guess, Kevin, anything to flag there? Is that the core Maryland facility? Is it fabrics? How should we think about CapEx here?

    好的。或許可以就此展開後續報道。我猜想,資本支出也比去年增加了3倍。凱文,我想問,這方面有什麼需要注意的嗎?那是馬裡蘭州的核心設施嗎?是布料嗎?我們該如何看待這裡的資本支出?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • It's primarily all pulling forward some additional sequencers as we scale. Obviously, the business, we think, has achieved great economies of scale such that we're able to exponentially grow volumes without matching adding resources one for one. But as we grow, we're going to have to add more to the sequencer line. And so what you see in the third quarter, by and large, is really just some sequencer technology to keep pace with the volume. The facility itself has plenty of room in it.

    隨著規模的擴大,主要就是增加一些額外的音序器。顯然,我們認為,該業務已經實現了巨大的規模經濟,因此我們能夠在不逐一增加資源的情況下實現銷量的指數級增長。但隨著我們的發展,我們將不得不增加更多音序器產品線。因此,你在第三季度看到的,總體而言,實際上只是一些音序器技術,以跟上銷量的成長。設施本身空間充足。

  • And yes, we're still operating the core laboratory down in Gaithersburg, Maryland. Very little from the fabric side.

    是的,我們仍然在馬裡蘭州蓋瑟斯堡經營核心實驗室。面料方面幾乎沒有什麼。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • Okay. And then maybe just shifting to denial rates. Can you give us a sense of where you ended the quarter? I understand your ASP commentary for the fourth quarter, but how are you thinking about denial rates and how much leverage you will have maybe first half of '26?

    好的。然後或許可以轉而關注拒付率。能否大致介紹一下本季末的業績狀況?我理解您對第四季度平均售價的評論,但是您如何看待拒付率以及您在 2026 年上半年可能擁有的議價能力?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • It's mid- to high 50% collection rate, picked up a nice basis point or 2 on that with the rate in the 3,800s. -- really pleased with the progress of the team. I think what's most exciting is if you look at that Medicaid population in the 36 or 35 states up until next week, the 35 states with coverage outpatient, we're seeing a really high payment rate of about 80% fairly consistently, pretty clear rules to follow. and not some of the nonmedical denials that we see over the commercial insurers. But the aggregate rate have picked up some towards the high 50s in terms of collection rate.

    回收率在50%到50%之間,利率在3800多,比之前提高了一兩個基點——我對團隊的進展非常滿意。我認為最令人興奮的是,如果你觀察一下截至下週的36或35個州(即35個提供門診服務的州)的醫療補助人群,我們會發現他們的支付率非常高,穩定在80%左右,而且規則也相當明確。不像商業保險公司那樣,會出現一些非醫療原因的拒付。但整體而言,收款率已經回升,接近 50%。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • Okay. Last point, Katherine, can we get an update on how some of the earlier launches this year have tracked cerebral palsy, IEI, et cetera?

    好的。凱瑟琳,最後一點,能否更新一下今年早些時候推出的一些產品在追蹤腦性麻痺、IEI 等疾病方面的情況?

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Yes. So I think as we have continued to roll out additional new indications, and again, there's 10,000 rare diseases. So we're just going to be routinely cranking out new indications over time. I think that's part of the reason why we're seeing the strong growth. It's contributing.

    是的。所以我認為,隨著我們不斷推出新的適應症,而且,目前已知有 10,000 種罕見疾病。所以我們會隨著時間的推移,不斷推出新的指標。我認為這是我們看到強勁成長的部分原因。它起到了一定的作用。

  • A lot of the symptoms are overlapping. So you might have a rep who is talking about symptoms associated with epilepsy and it turns out its cerebral palsy. You might have a rep going in talking about cerebral palsy and it turns out that it's epilepsy. Some of these -- there are dual diagnoses.

    很多症狀都有重疊之處。所以你可能會遇到一位代表,他談論的是與癲癇相關的症狀,但結果卻發現那是腦性麻痺。你可能帶著一位聲稱自己患有腦性麻痺的代表去拜訪病人,結果卻發現他患的是癲癇。有些病例存在雙重診斷。

  • So there are very -- the new indications are certainly contributing to our growth. And I think it just speaks to the vast underutilization of testing for so many of these kids. So we'll continue to have kind of rolling indications launch. This is a core part of the way that we operate the business.

    所以,這些新跡象無疑正在促進我們的成長。我認為這正好說明很多孩子都沒有得到充分的測試機會。所以我們會繼續採取滾動式指標發布的方式。這是我們業務運作方式的核心組成部分。

  • Operator

    Operator

  • David Westenberg, Piper Sandler.

    大衛‧韋斯滕伯格,派珀‧桑德勒。

  • David Westenberg - Analyst

    David Westenberg - Analyst

  • I apologize if I asked something I've been jumping between calls. Can you give us an incremental -- a sense for the incremental revenue opportunity with the expansion of Medi-Cal and what the strategy is for securing the remaining 14 states? And how should we think about timing there? And I'll just have one more.

    如果我問了什麼問題,請見諒,我一直在接電話。您能否簡要介紹 Medi-Cal 擴大後帶來的增量收入機會,以及爭取其餘 14 個州加入該計劃的策略是什麼?那我們該如何考慮時機呢?我再來一杯。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yes. Look, with California being the most densely populated state, certainly a nice win. The probably next largest to come would be Massachusetts. So really exciting to see California come online next week in a couple of days.

    是的。加州是人口密度最高的州,這無疑是一場漂亮的勝利。接下來可能最大的州是馬薩諸塞州。加州即將上線,真是令人興奮!

  • Today, a couple of thousand tests that would have run through as zeros that now we might expect to get paid for. Obviously, we have to build up some history and experience to see that. And of course, with coverage now, a more focused effort to calibrate and pull more volumes through the state. So excited about a larger opportunity ahead beyond the existing volume that we have.

    今天,幾千項原本會以零分通過的測試,現在我們或許可以期待獲得報酬。顯然,我們需要累積一些歷史經驗才能明白這一點。當然,隨著覆蓋範圍的擴大,我們將更加集中精力進行校準,並透過全州管道收集更多數據。我們對未來更大的發展機會感到非常興奮,它將超越我們目前的業務規模。

  • And then the second part of your question, Dave.

    然後是你問題的第二部分,戴夫。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Strategy is for other states to come online from Medicare. So we've got a fantastic market access team that we only continue to bolster. We now have an East and West government affairs leader. And so they're continuing to put good data, great guidelines, health economics data in front of the state-by-state Medicaid officers. And we work with local clinicians, local parent advocates.

    策略是讓其他州也加入聯邦醫療保險計劃。所以我們擁有一支非常優秀的市場進入團隊,而且我們還在不斷加強這支團隊。我們現在有了一位負責東西方政府事務的負責人。因此,他們繼續向各州的醫療補助官員提供可靠的數據、優秀的指導方針和衛生經濟學數據。我們與當地臨床醫生和當地家長倡議者合作。

  • So it's -- I would say it's a well-oiled machine, but it's within their control, not ours. So we're just getting playbook. We know they respond well, particularly to the health economic data. The reality is we are paying for these children and the absence of accurate diagnosis one way or another using our testing upfront is an opportunity to get to the right diagnosis sooner and save all of these payers. So that message is resonating.

    所以——我會說它是一台運作良好的機器,但這都在他們的控制之下,而不是我們的。所以我們現在只是在學習作戰手冊。我們知道他們反應良好,尤其對衛生經濟數據反應良好。現實情況是,我們為這些孩子支付了費用,而我們前期進行的檢測卻未能以任何方式做出準確診斷,這錯失了儘早做出正確診斷、為所有付款人節省開支的機會。看來這則訊息引起了共鳴。

  • So we'll continue to drive that until we have every single state with inpatient, outpatient. And as I said earlier, then we move on a new work. So we've got our work cut out for us, but a very optimistic path ahead.

    所以我們會繼續推進這項工作,直到每個州都有住院和門診服務。正如我之前所說,然後我們就開始新的工作。所以,我們還有很多工作要做,但前路充滿希望。

  • David Westenberg - Analyst

    David Westenberg - Analyst

  • Sounds great. I just wanted to ask one longer-term question, and that is about pricing in the longer term. Now a lot of times you're billing for codes of exome and genome. Now saying that not all exomes and genomes are the same, and there's a constant need to integrate things like methylation, long reads, skillful informatics, do you think that payers understand that constant innovation is necessary to enhance diagnostic yields and you're able to retain pricing over the long term?

    聽起來不錯。我只想問一個更長遠的問題,那就是關於長期定價的問題。現在很多時候,你是按外顯子組和基因組的編碼進行計費的。現在,既然並非所有外顯子組和基因組都相同,而且需要不斷整合甲基化、長讀長定序、熟練的資訊學等技術,您認為支付方是否理解持續創新對於提高診斷率和長期維持價格至關重要?

  • And consequently to that, when you're thinking about new competitors coming in, do you feel like the constant need for improving the test does maintain pricing long term because you will be constantly needing to enhance the assays?

    因此,當您考慮新的競爭對手進入市場時,您是否認為不斷改進測試的需求能夠長期維持價格,因為您需要不斷改進檢測方法?

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Yes. Thank you, Dave. And I ask Bryan and Kevin to tag team this because I think it speaks to, one, what we're doing today beyond short read, but two, also why Infinity and that data set sets us apart from others.

    是的。謝謝你,戴夫。我請布萊恩和凱文聯手完成這項工作,因為我認為這不僅說明了我們今天在短篇閱讀之外所做的事情,也說明了為什麼 Infinity 和該數據集使我們與眾不同。

  • Bryan Dechairo - Chief Operating Officer

    Bryan Dechairo - Chief Operating Officer

  • Thanks, Katherine. So on the technology front, it's really our job to continue to innovate and fund that innovation to bring the best answers to patients every day. We already have seen that with the indication expansions as we move more and more people off of panels and into genome and exome, which is what's driving the growth that we've been seeing and will continue to drive a lot of that growth.

    謝謝你,凱瑟琳。因此,在技術方面,我們的職責是不斷創新,並為創新提供資金,以便每天為患者帶來最佳解決方案。我們已經看到,隨著越來越多的人從基因檢測面板轉向基因組和外顯子組檢測,適應症範圍不斷擴大,這正是我們所看到的增長的驅動力,並將繼續推動這種增長。

  • And that takes new technologies, technologies around medium and long-read sequencing, multimodal technologies that we discussed. But what's great is that the scale of our operations that we continue to scale, we are actually able to be driving down cost of goods as we bring in more and more innovations. And so you're not seeing an increase in COGS as the innovations roll out into production. You're actually seeing COGS continue to come down with those innovations with higher diagnostic yield. And really only GeneDx with our scale can deliver that quality.

    這就需要新技術,圍繞著中長讀長定序的技術,以及我們討論過的多模態技術。但令人欣慰的是,隨著我們業務規模的不斷擴大,我們能夠不斷引入創新,從而降低商品成本。因此,隨著創新技術投入生產,你不會看到銷售成本增加。實際上,隨著診斷率的提高,成本正在持續下降。只有像 GeneDx 這樣規模的公司才能真正提供這種品質。

  • I'll hand it over to Kevin to talk about the reimbursement.

    我會把這件事交給凱文,讓他談談報銷事宜。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yes. Let's assume that's an issue with Dave's technology. To follow up with Bryan's comments, look, it's upon us to prove the value proposition of all of our services to payers. And so we're hard at work doing so. We've always viewed the long-term durability of our rates at that average reimbursement or cash collection rate.

    是的。假設這是戴夫的技術問題。為了回應布萊恩的評論,我們有責任向付款方證明我們所有服務的價值主張。所以我們正在努力實現這個目標。我們一直認為,平均報銷率或現金收款率能夠保證我們費率的長期穩定性。

  • Potentially, over time, you might see the billable rate come down, but we're still facing a dynamic today where we just produced $3,800 a test despite having a denial rate in the mid-40s. And we absolutely think that we can improve upon that in a meaningful way. And so continue to believe that, that average collection rate will be at or higher than today's levels for the foreseeable future over time.

    隨著時間的推移,計費率可能會下降,但我們目前面臨的情況是,儘管拒付率高達 40% 以上,但每次測試的收入仍然達到了 3800 美元。我們絕對認為我們可以在這一點上做出有意義的改進。因此,我們繼續相信,在可預見的未來,平均收款率將達到或高於目前的水平。

  • (technical difficulty)

    (技術難題)

  • Operator

    Operator

  • Bill Bonello, Craig Hallum.

    比爾·博內洛,克雷格·哈勒姆。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • No, I was kind of interested in hearing where David was going to go with that conversation.

    不,我其實挺想聽聽大衛接下來會如何展開這個話題。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Bill, you get to riff on it now.

    比爾,現在輪到你即興發揮了。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • So virtually everything interesting and noninteresting has already been asked. I just want to clarify one thing on the margin front with the incremental investments that you obviously need to make drive growth, drive these new opportunities. Is the thinking right now that you would at least try and sort of maintain the level of EBITDA margin where you are at? Or should we think about this more as in the interim, we may see EBITDA margin drop down a little bit as you set up for a future where it could be significantly better?

    所以,幾乎所有有趣的和不有趣的問題都已經被問過了。我只想澄清一點關於利潤率方面的問題,即為了推動成長、抓住這些新機遇,您顯然需要進行增量投資。目前你們的想法是至少嘗試維持目前的 EBITDA 利潤率水準嗎?或者我們應該多考慮這一點:在此期間,隨著公司為未來可能大幅改善的情況做準備,我們可能會看到 EBITDA 利潤率略有下降?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yes. Certainly all within the framework and design of a future where it's significantly better. But we're entering an investment cycle here. Not every quarter will be different, and we'll have more to say about 2026 at our Q4 call. So -- but may see that EBITDA margin come down in some of these quarters as we ramp up investments and then wait to see those investments mature in terms of top line contribution.

    是的。當然,這一切都是在未來更美好的願景框架和設計之下進行的。但我們正進入一個投資週期。並非每季都會有所不同,關於 2026 年,我們將在第四季電話會議上做更多說明。所以——但隨著我們加強投資力度,可能會看到某些季度的 EBITDA 利潤率下降,然後等待這些投資在營收貢獻方面成熟。

  • I read through the commitment as keeping it in the black and positive, but not necessarily at these levels. But certainly, we think the business model has proven the ability to accrete EPS upwards, and there will be a time and place when we focus back on doing that. But for now, there's such a large opportunity ahead. We think it's important we make some of these investments to take advantage of that.

    我的理解是,這份承諾旨在保持獲利,但並不一定能達到這樣的水平。但可以肯定的是,我們認為這種商業模式已經證明了其能夠提高每股收益,而且將來某個時候我們會重新專注於此。但就目前而言,前方蘊藏著巨大的機會。我們認為進行一些此類投資以利用這些機會非常重要。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Okay. That's helpful. And then just the second thing, as I talk to people, there always seems to be some skepticism about the 18 to 24 months and to avoid the possibility that people get sort of overly exuberant here. Can you maybe just talk through in a little bit more detail some of the steps that need to be completed before you can really see a meaningful ramp in the general pediatrician market.

    好的。那很有幫助。其次,當我與人們交談時,他們似乎總是對 18 到 24 個月的時間持懷疑態度,為了避免人們過於樂觀,我建議採用這個時間。您能否更詳細地談談在真正看到兒科醫生市場出現實質成長之前需要完成的一些步驟?

  • You talked about the sales force, obviously, has to be recruited and trained, but you also mentioned some things that you want to do with the ordering platform and the results delivery platform. What -- maybe you can tell us a little bit more about that and just other -- some of the other basic nuts and bolts kind of work that is required to expand into a totally new segment of the market.

    您提到了銷售團隊,顯然需要進行招募和培訓,但您也提到了一些您想在訂購平台和結果交付平台上做的事情。您能否再詳細介紹一下這方面以及其他一些拓展到全新市場領域所需的基本操作方面的內容?

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Yes. Thank you for that, Bill. So education is key. As I said, most of these pediatricians are learning about the guidelines update from us. We need to make it relevant for them.

    是的。謝謝你,比爾。所以教育至關重要。正如我所說,這些兒科醫生大多都是從我們這裡了解指南更新的。我們需要讓它與他們息息相關。

  • They're seeing a whole host of symptoms and issues coming into their clinic. And we have to do a lot to dispel some of the myths related to genomics. They think that it's going to take a long time. It's going to be confusing to understand. It's going to be hard to order that a geneticist should be the one ordering it.

    他們診所接診的患者出現了各種不同的症狀和問題。我們必須做很多工作來消除一些與基因組學相關的誤解。他們認為這將需要很長時間。理解起來可能會比較困難。很難說應該由遺傳學家來下這樣的命令。

  • And when we come in and we explain to them that it is covered by insurance, we can turn around their sample within a few weeks, and we're going to provide a simplified report. It changes the way that they're thinking about things. So I would say education is key to kind of setting the record straight about what we can and cannot do.

    當我們到場並向他們解釋保險涵蓋範圍後,我們可以在幾週內處理他們的樣品,並提供簡化的報告。它改變了他們思考問題的方式。所以我認為教育是澄清我們能做什麼、不能做什麼的關鍵。

  • Also educating them, there's still -- there could be 12 to 24 months to begin to see a geneticist. So they may say that they would like to send a patient to a geneticist. But if you say, well, if that delays a diagnosis by 12 to 24 months, then they don't want to see that happen. They want to activate in that moment. So we're getting a lot of good, I would say, market research feedback that affirms the need to continue to educate.

    此外,對他們進行教育也需要時間——可能需要 12 到 24 個月才能開始去看遺傳學家。所以他們可能會說,他們想把病人轉診給遺傳學家。但如果你說,如果這會導致診斷延遲 12 到 24 個月,那麼他們就不希望這種情況發生。他們想在那一刻採取行動。因此,我們獲得了許多很好的市場調查回饋,這些回饋證實了繼續進行教育的必要性。

  • So education is one. Coming out of that, too, yes, we talked about workflow. Their time is precious.

    所以教育是其中之一。是的,在那之後,我們也討論了工作流程。他們的時間很寶貴。

  • And so how do we take our ordering platform today and bring it to what Bryan said was a one-minute ordering approach. So we're building that capability as well as other ways to ensure that we can unburden the pediatrician from some of the administrative work that they may have to do. So workflow is another key investment market access and ensuring that our market access team is delivering a dossier with these updated guidelines is going to be critically important. So they've started doing that. So that's the third piece.

    那麼,我們如何將我們今天的訂購平台轉變為布萊恩所說的「一分鐘訂購」模式呢?因此,我們正在建立這種能力以及其他方法,以確保我們能夠減輕兒科醫生的一些行政工作負擔。因此,工作流程是另一個關鍵的投資市場准入問題,確保我們的市場准入團隊提交一份包含這些更新指南的文件至關重要。所以他們已經開始這麼做了。這是第三部分。

  • And then fourth is the sales rep and the sales rep going in and doing a lot of the kind of hand-to-hand combat in terms of education. But that's part of the reason why we're investing now. We would love to see an acceleration of that 18 to 24 months, but we know that there's a lot of work that we have to deliver on to educate and to smooth things out and make it easier for these clinicians to order.

    第四點是銷售代表,銷售代表會深入客戶,進行大量的實戰式教育。但這正是我們現在進行投資的部分原因。我們當然希望看到這 18 到 24 個月的進程加快,但我們也知道,我們還有很多工作要做,例如進行教育、理順流程,讓這些臨床醫生更容易下單。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yes. Look, if the skepticism is that we'll beat the timeframe we set out, I guess I'd characterize that as a high-quality problem. Will it be more than zero in 2026? It will be more than zero in 2026 in general pediatricians. But -- we want to make sure we're approaching the market in a responsible way that really sets the stage for the company's growth over the next half a decade to decade. And you only get one good first impression, and we intend to make that.

    是的。你看,如果人們懷疑我們能否在設定的時間內完成任務,我想我會把這描述成一個高品質的問題。到2026年,這個數字會大於零嗎?到 2026 年,普通兒科醫生的數字將大於零。但是——我們希望確保以負責任的方式進入市場,真正為公司未來五到十年的發展奠定基礎。第一印像只有一次,而我們​​決心要給人留下好印象。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Yes. That makes a ton of sense. And one last question just along that line, and you just may not care to answer this at this point. But in some of the areas where we've been seeing companies reach out to primary care physician markets, which obviously a lot larger, but not a ton different than the conceptually than reaching out to the pediatric market. We've seen companies with specialized tests partner with some of the larger lab companies with broad menus to make ordering of testing a little bit easier, even results delivery a little bit easier. Is that something you would consider?

    是的。這很有道理。最後一個問題也和這個有關,不過你可能現在不想回答。但在某些地區,我們看到一些公司開始接觸初級保健醫生市場,這個市場顯然要大得多,但從概念上講,它與接觸兒科市場並沒有太大的不同。我們看到一些擁有專業檢測項目的公司與一些擁有廣泛檢測項目的大型實驗室公司合作,使檢測訂購更加便捷,甚至結果交付也更加便捷。你會考慮這樣做嗎?

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Look, we're always thinking about new channels and ways to help more patients. So I wouldn't say no, we would not consider that if there's an opportunity for us to drive our business forward, help more families. Certainly. In our experience, we haven't seen that work because it tends to not be the highest priority on the part of the partner. But certainly, we would be open to it.

    我們一直在思考如何透過新的管道和方式來幫助更多的患者。所以,我不會說不,如果這是一個能推動我們業務發展、幫助更多家庭的機會,我們不會不考慮。當然。根據我們的經驗,我們還沒有看到這種方法奏效,因為這往往不是合作夥伴的首要任務。當然,我們對此持開放態度。

  • So for now, our plan is to make sure that we can drive as much of the business forward as we can in service of more patients. So we're placing a bet on what we know works, which is our team.

    所以目前,我們的計劃是確保我們能夠盡可能地推動業務發展,從而服務更多的患者。所以,我們把賭注押在了我們知道行之有效的方法上,那就是我們的團隊。

  • Bryan Dechairo - Chief Operating Officer

    Bryan Dechairo - Chief Operating Officer

  • I'd also add that we've been around for 25 years and pediatricians have seen their patients who they stay with for 18 years, these kids come back to them with our reports. And when we did market research to look at what was the brand that they thought of when it came to genetics, GeneDx was the number one brand over all other testing companies, even the ones that they use every day for other tests. And so I think with that recognition and with the understanding that our test is number one in the space, it makes sense for us to continue with the models that we're exploring.

    我還要補充一點,我們已經成立 25 年了,兒科醫生已經觀察他們的病人長達 18 年,這些孩子帶著我們的報告回來找他們。當我們進行市場調查,了解他們在想到基因檢測時會想到哪個品牌時,GeneDx 是所有檢測公司中排名第一的品牌,甚至超過了他們每天用於其他檢測的公司。因此,我認為,鑑於我們認識到我們的測試是該領域第一,並且理解我們的測試是該領域第一,那麼我們繼續探索我們正在研究的模型就很有意義了。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Yes, makes a ton of sense.

    是的,很有道理。

  • Operator

    Operator

  • Kyle Mikson, Canaccord.

    Kyle Mikson,Canaccord。

  • Kyle Mikson - Equity Analyst

    Kyle Mikson - Equity Analyst

  • Congrats on the quarter. So Kevin, on the Medi-Cal impact, California is obviously large. It's densely populated, as you said. How significant of an ASP and gross margin headwind is that going to be? And then how long will that dynamic take to stabilize and then approach the higher kind of core ASP and gross margin?

    恭喜你本季取得佳績。所以凱文,關於 Medi-Cal 的影響,加州顯然是一個很大的國家。正如你所說,那裡人口密度很高。這將對平均售價和毛利率造成多大的不利影響?那麼,這種動態需要多久才能穩定下來,並且接近更高的核心平均售價和毛利率呢?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yes. Look, we're excited that Medi-Cal news, of course, will further bolster the reimbursement environment here. So it's certainly positive. So consider it a tailwind. Those are tests, at least the existing volume or tests that we're running and taking zeros on today. And starting next week, we'd expect to get paid for that volume.

    是的。當然,我們很高興看到 Medi-Cal 的最新消息,這將進一步改善這裡的報銷環境。所以這當然是好事。所以,不妨把它當成順風。這些是測試,至少是我們目前正在運行的現有測試量或測試,而今天這些測試的結果都是零。從下週開始,我們預計會收到相應數量的款項。

  • The couple of thousand tests, I think, would understate the long-term opportunity with now Medicaid coverage in hand, it's certainly a nice talking point for our commercial team to get out there, spread that work and begin to pull in even more volumes. We're serving all 50 states, but at various levels. And so in those states where there's good reimbursement coverage, that's where we tend to amplify sales resources to pull in more volume, and we certainly plan on doing so moving forward.

    我認為,數千次的測試數量低估了長期的機遇,現在有了醫療補助計劃的覆蓋,這無疑是一個很好的談資,可以讓我們的商業團隊走出去,擴大業務範圍,並開始吸引更多的銷售。我們為美國所有50個州提供服務,但服務水準參差不齊。因此,在那些報銷覆蓋範圍廣的州,我們往往會加大銷售資源投入,以吸引更多銷量,而且我們當然計劃在未來繼續這樣做。

  • Kyle Mikson - Equity Analyst

    Kyle Mikson - Equity Analyst

  • Just to clarify, so payment collection rate would go from 0 to like 80% overnight, your kind of saying in United States?

    我確認一下,你是說收款率一夕之間從0%飆升到80%嗎?這是美國常用的說法嗎?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yes. Still waiting on the ultimate price from the Medicaid administrator, but we expect it to be in line with other states that have gone live with coverage.

    是的。我們仍在等待醫療補助管理機構的最終價格,但我們預計價格將與其他已實施該項涵蓋的州的價格一致。

  • Kyle Mikson - Equity Analyst

    Kyle Mikson - Equity Analyst

  • Okay. Sounds good. And then Katherine, on the longer-term kind of data business, Infinity AI and multicore, your kind of emphasizing that recently. Could you just contextualize the competitive moat that provides and what the future kind of holds there?

    好的。聽起來不錯。然後,凱瑟琳,關於長期數據業務、Infinity AI 和多核,你最近一直在強調這一點。能否具體說明一下這種競爭優勢所帶來的影響,以及它未來的發展前景?

  • And then I think a follow-up to Dave's question, how critical is the longer-range sequencing data going to be to advance that asset, specifically the medium-range kind of sequencing from Roche or longer read with PacBio, et cetera?

    然後,我想就 Dave 的問題做個後續探討,長距離定序資料對於推進該資產的發展究竟有多重要,特別是羅氏公司的中距離定序或 PacBio 公司的長讀長定序等等?

  • Bryan Dechairo - Chief Operating Officer

    Bryan Dechairo - Chief Operating Officer

  • Yes. Let me take that two parts. First is the Infinity database that you just were mentioning. As I mentioned in my earlier comments, the power of that database is the fact that it's a massive reservoir of variants that we have seen in patients that have yet to be validated by a second patient. But every day, with the volume that we're having, we're validating more and more and growing that database over time.

    是的。讓我來分成兩部分來講解。首先是您剛才提到的 Infinity 資料庫。正如我在先前的評論中提到的,該資料庫的強大之處在於,它是一個龐大的變異庫,其中包含了我們在患者身上發現的、尚未被第二個患者驗證的變異。但是,隨著我們每天處理的數據量不斷增長,我們每天都在驗證越來越多的數據,並且隨著時間的推移,我們的資料庫也在不斷擴大。

  • And so the AI tools that we put on top our machine learning multicore, it really just improves the accuracy, the speed and the efficiency that our clinical experts can go through and find those diagnosis. It gives us the highest accuracy in that space.

    因此,我們在機器學習多核心處理器上部署的 AI 工具,確實提高了臨床專家進行診斷的準確性、速度和效率。它為我們提供了該領域最高的精度。

  • But as you're also mentioning, those same AI tools become value add to our partners like pharma, employers, and others as they go out and look at the Infinity database, look at the data that it sees and really starts to actually open up the ability to have more and more drug targets, more therapies and bring more solutions to these children with these devastating diagnoses over time. And so we really see that those AI approach is expanding into our pharma and our other partnerships around the globe.

    但正如您所提到的,這些人工智慧工具也為我們的合作夥伴(如製藥公司、雇主和其他機構)帶來了價值,因為他們可以查看 Infinity 資料庫,查看它所看到的數據,並真正開始能夠找到越來越多的藥物靶點、更多的療法,並隨著時間的推移為這些患有毀滅性疾病的兒童帶來更多的解決方案。因此,我們確實看到人工智慧方法正在擴展到我們的製藥業務以及我們在全球的其他合作夥伴關係中。

  • As far as our technology, the genome needs -- has some gaps in it. There's some difficult to sequence regions that we know about, which is why there are still some panels that people will order. Every time that we bring in a medium read or a long read or other type of technologies, it really starts to improve the diagnostic yield for some of these other conditions, which again converts more and more folks off of panels and into the exome and genome as the best answer for all patients. And we are continuing to add more and more of these technologies for the right patients with the right phenotype.

    就我們的技術而言,基因組需要——還存在一些不足之處。我們知道有些區域難以定序,所以仍然有人會訂購一些定序板。每次我們引入中等讀長或長讀長或其他類型的技術時,都會真正開始提高某些其他疾病的診斷率,這又會使越來越多的人放棄基因檢測,轉而接受外顯子組和基因組檢測,認為這是所有患者的最佳答案。我們正在不斷增加這些技術的應用,以用於具有合適表型的合適患者。

  • Operator

    Operator

  • Keith Hilton (sic – Hinton), Freedom Capital Markets.

    Keith Hilton (原文如此,應為 Hinton),Freedom Capital Markets。

  • Keith Hinton - Analyst

    Keith Hinton - Analyst

  • Just two quick ones. First one on the ExGen volumes. Just based on the volume split for second half of '25 that you talked about on the second quarter call, it seems like volume in the quarter slightly exceeded your internal expectations. So just can you talk a little bit about where you outperformed versus your internal expectations and maybe why you decided to leave the full year guide unchanged despite the beat?

    就兩個簡單的問題。第一卷是ExGen系列。僅根據您在第二季電話會議上提到的 2025 年下半年的銷售佔比來看,該季度的銷售似乎略微超出了您的內部預期。那麼,您能否談談您在哪些方面超出了內部預期,以及儘管業績超出預期,為什麼您決定維持全年業績指引不變?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yes, we saw good momentum through the third quarter with accelerating volumes each month of the quarter. And so wrapped up September sort of as expected with the high point of the quarter and momentum has continued nicely.

    是的,第三季發展勢頭良好,每個月的銷售量都在加速成長。9 月的結束基本上符合預期,達到了季度高峰,並且勢頭一直保持良好。

  • The outperformance mostly coming in the -- or primarily coming in the outpatient side of the business. Really forming that ped neuro call point. So most of the outperformance there coming from that physician type, and we continue to see a lot of space to go activate more ped neuros and bring in more volume. Overall, really pleased with the third quarter performance.

    業績優異主要體現在──或者說主要體現在門診業務方面。真正形成兒科神經學呼叫點。因此,大部分的優異表現都來自這類醫生,我們仍然看到有很多空間去激活更多的兒科神經科醫生,並帶來更多的病例量。整體而言,我對第三季的表現非常滿意。

  • Keith Hinton - Analyst

    Keith Hinton - Analyst

  • Okay. Great. And then just one more question about the launch in general pediatricians, just less so about the sales force and more talking about any kind of buildup you need to do on the back end in terms of adding additional billing and revenue cycle folks to make sure the ASP doesn't drop too much, DTC spending, the parents, anything like that? Can you talk through how we should be thinking about the magnitude there? And also, is there any concern that there could be a bottleneck around genetic counseling for those patients that do have variants that come back that they need to better understand?

    好的。偉大的。那麼,關於面向普通兒科醫生的推廣,還有一個問題,與其說是關於銷售團隊,不如說是關於在後端需要做的任何準備工作,例如增加計費和收入周期方面的人員,以確保平均售價不會下降太多,以及直接面向消費者的支出、家長等等?您能詳細說說我們應該如何看待這個問題的規模嗎?此外,對於那些檢測出攜帶變異基因、需要更了解這些變異基因的患者來說,是否存在基因諮詢瓶頸的問題?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Part of those investments, as you rightly pointed out, are to ensure that there is no bottleneck in terms of genetic counseling resources or other support for nonexperts, both at the front end or back end of the process and translating those results to patients. And so those are core to the experience design changes that we'll be investing in. If you look at the expense ramp from Q2 to Q3, as I called out, from Q3 to Q4, I expect something in the same order of magnitude. And we'll have more to say as we frame out 2026. But again, would expect that there's ample gross margin to cover those reinvestments back in the business such that we'll keep the business profitable on an adjusted basis.

    正如您所指出的,這些投資的一部分是為了確保在遺傳諮詢資源或其他對非專業人士的支持方面不會出現瓶頸,無論是在流程的前端還是後端,以及將這些結果轉化為對患者的指導。因此,這些是我們將會投資的體驗設計變革的核心。如我之前所說,如果你看一下第二季到第三季的費用成長情況,那麼我預期第三季到第四季的費用成長幅度也將大致相同。隨著我們對 2026 年的規劃不斷深入,我們將有更多內容要闡述。但同樣,預計毛利率足以涵蓋這些再投資,使公司在調整後仍能保持獲利。

  • Operator

    Operator

  • Thank you. This does conclude today's Q&A session. I would now like to turn the call back over to Katherine Stueland for closing remarks. Please go ahead.

    謝謝。今天的問答環節到此結束。現在我謹將電話交還給凱瑟琳‧斯圖蘭德,請她作總結發言。請繼續。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Wonderful. Well, on behalf of all the families who we serve, our customers and all of the employees at GeneDx, I just want to say thank you to our shareholders for continuing to support our long-term growth and changing healthcare for the better. So thank you all, and we look forward to seeing you soon over the coming days and weeks. Take care.

    精彩的。在此,我謹代表我們服務的所有家庭、我們的客戶以及 GeneDx 的所有員工,感謝我們的股東一直以來對我們長期發展和改善醫療保健的支持。所以,非常感謝大家,我們期待在接下來的幾天或幾週內與大家見面。小心。

  • Operator

    Operator

  • Thank you. This does conclude today's program. Thank you all for joining. You may now disconnect.

    謝謝。今天的節目到此結束。感謝各位的參與。您現在可以斷開連線了。