GeneDx Holdings Corp (WGS) 2025 Q1 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 first-quarter 2025 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

    您好,感謝您的支持。歡迎參加 GeneDx 2025 年第一季財報電話會議。(操作員指示)請注意,今天的會議正在錄音。

  • I would now like to hand the conference over to your speaker today. Sabrina Dunbar, Investor Relations. Please go ahead.

    現在我想將會議交給今天的發言人。薩布麗娜‧鄧巴 (Sabrina Dunbar),投資者關係部。請繼續。

  • Sabrina Dunbar - Investor Relations

    Sabrina Dunbar - Investor Relations

  • Thank you, operator, and thank you, everyone, for joining us today. On the call, we have Katherine Stueland, President and Chief Executive Officer; and Kevin Feeley, Chief Financial Officer. Earlier today, GeneDx released financial results for the first quarter ended March 31, 2025.

    謝謝接線生,也謝謝大家今天加入我們。參加電話會議的有總裁兼執行長 Katherine Stueland;以及財務長 Kevin Feeley。今天早些時候,GeneDx 發布了截至 2025 年 3 月 31 日的第一季財務業績。

  • Before we begin, please take note of (technical difficulty) 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, April 30; and we're under no obligation to update.

    在我們開始之前,請注意(技術難度)聲明。我們可能會在今天的電話會議上做出前瞻性陳述,包括我們的業務計劃、更新的 2025 年指引和展望。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(4 月 30 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 first-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.

    在討論我們的結果時,我們參考非公認會計準則指標,該指標從報告結果中排除了某些項目。請參閱我們在 ir.genedx.com 上發布的 2025 年第一季度收益報告和幻燈片,了解非 GAAP 指標的定義和對帳以及有關我們業績的其他信息,包括可能導致實際結果與前瞻性陳述存在重大差異的因素的討論。

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

    說完這些,我會把電話轉給凱瑟琳。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Thank you, Sabrina, and good morning, everyone.

    謝謝你,薩布麗娜,大家早安。

  • Our team's work surpassed our expectations and delivered a strong first quarter with revenues exceeding $87 million and our third consecutive quarter of profitability. We're raising guidance for the year to $360 million to $375 million, successfully building on last year's momentum and strengthening our industry-leading position centered on diagnosing any genetic disease as early as possible with whole exome and genome sequencing.

    我們團隊的工作超出了我們的預期,第一季業績強勁,收入超過 8700 萬美元,連續第三個季度實現盈利。我們將今年的指導金額提高到 3.6 億美元至 3.75 億美元,成功地延續了去年的勢頭,並加強了我們以利用全外顯子組和基因組測序儘早診斷任何遺傳疾病為中心的行業領先地位。

  • Our healthcare system today is broken. We're waiting for children to get sick and letting their disease continue to progress for far too long, severely limiting their chances of living longer and healthier lives. It still takes, on average, five years for a child with a genetic disease to get an accurate diagnosis. That's unconscionable given what we can do today.

    我們今天的醫療保健系統已經崩潰。我們等待孩子們生病,並讓他們的病情持續發展太長時間,嚴重限制了他們活得更長壽、更健康的機會。患有遺傳疾病的兒童平均仍需五年時間才能準確診斷。考慮到我們今天所能做的,這是不合理的。

  • Our tests are not just diagnostic tools. They're proactive solutions that can transform how we approach genetic diseases. For patients, that means less time in diagnostic purgatory and more time on the right path to care. For the healthcare system, it means fewer unnecessary procedures, reduced misdiagnoses, and a significant decrease in costs.

    我們的測試不僅僅是診斷工具。它們是積極的解決方案,可以改變我們治療遺傳疾病的方式。對患者來說,這意味著減少診斷過程中的時間,而將更多的時間花在正確的治療上。對於醫療保健系統來說,這意味著減少不必要的程序、減少誤診並大幅降低成本。

  • We believe that integrating exome and genome testing more proactively as the standard of care isn't just better medicine, it's smarter policy, particularly at a time when valuable healthcare dollars is a national priority. Our technology enables the shift from reactive to proactive care, benefiting both individual patients and the healthcare system as a whole.

    我們相信,將外顯子組和基因組檢測更積極地整合為護理標準不僅是更好的醫療,也是更明智的政策,特別是在寶貴的醫療保健資金成為國家優先事項的時期。我們的技術實現了從被動護理到主動護理的轉變,使個別患者和整個醫療保健系統都受益。

  • In the outpatient setting, we've expanded into new clinical indications. And in the NICU, we've laid the foundational infrastructure to translate our leadership into that critically important setting where fewer than 5% of babies even get a genetic test. But our sights are set on helping adults, too.

    在門診方面,我們已經擴展到新的臨床適應症。在新生兒加護病房 (NICU),我們奠定了基礎基礎設施,將我們的領導地位轉化為至關重要的場所,在這個場所,只有不到 5% 的嬰兒接受過基因檢測。但我們的目光也在於幫助成年人。

  • Our growth strategy ties directly to guidelines, reimbursement, and biopharma solutions. So you'll always hear us talk about volume growth and average reimbursement rates hand in hand.

    我們的成長策略與指導方針、報銷和生物製藥解決方案直接相關。因此,您總是會聽到我們同時談論銷售成長和平均報銷率。

  • Not all exome and genome tests are created equal, and there's a reason 8 out of 10 clinicians who order exome testing choose GeneDx. Fueled by more than 800,000 exomes and genomes, our rapidly growing data asset and clinical expertise set GeneDx apart. We continue to deploy innovative technologies at scale to enhance our products and create the best-in-class patient and clinician experience at GeneDx.

    並非所有外顯子組和基因組測試都是一樣的,因此,10 位進行外顯子組測試的臨床醫生中有 8 位選擇 GeneDx 是有原因的。憑藉超過 80 萬個外顯子組和基因組,我們快速成長的數據資產和臨床專業知識使 GeneDx 脫穎而出。我們將繼續大規模部署創新技術,以增強我們的產品並在 GeneDx 創造一流的患者和臨床醫生體驗。

  • Our winning growth strategy continue to support our commercial success in the outpatient setting, where we grew our market penetration of pediatric neurologists to 14%. Our business remains best positioned to capture the opportunities ahead, and we're seizing our advantage to accelerate market development.

    我們成功的成長策略持續支持我們在門診領域的商業成功,我們將兒科神經科醫生的市場滲透率提高到了 14%。我們的業務仍處於最佳位置,可以抓住未來的機遇,我們正在抓住優勢,加速市場發展。

  • In the inpatient setting, we continue to build upon the foundational infrastructure we began putting in place in Q4 2024. We recently launched our ultraRapid Genome Sequencing product, which delivers results in as soon as 48 hours. Our integration with Epic continues to progress, enhancing our ability to provide rapid and accurate diagnoses at the bedside.

    在住院環境中,我們將繼續鞏固 2024 年第四季開始建立的基礎設施。我們最近推出了超快速基因組定序產品,最快可在 48 小時內提供結果。我們與 Epic 的整合正在不斷推進,增強了我們在床邊提供快速且準確診斷的能力。

  • Our collaboration with the University of Washington and Seattle Children's, called Seqfirst, published data in the first quarter that demonstrates up to 60% of babies in level four NICU should receive a rapid genome test. Clinical research, collaboration, and product innovation prime commercial markets, and we anticipate that the combination of these factors will support a NICU volume ramp in the second half of the year.

    我們與華盛頓大學和西雅圖兒童醫院合作的 Seqfirst 計畫在第一季發布的數據顯示,四級新生兒加護病房 (NICU) 中多達 60% 的嬰兒應該接受快速基因組檢測。臨床研究、合作和產品創新是主要的商業市場,我們預計這些因素的結合將支持今年下半年 NICU 數量的成長。

  • We're setting the standard for genomic interpretation and analysis while ushering in the next phase of genomic medicine. By generating critical early evidence through the GUARDIAN study, GeneDx is championing one of the largest long-term opportunities in diagnostics, genomic newborn screening.

    我們正在為基因組解釋和分析制定標準,同時開啟基因組醫學的下一個階段。透過 GUARDIAN 研究產生關鍵的早期證據,GeneDx 正在倡導診斷領域最大的長期機會之一——新生兒基因組篩檢。

  • Our leadership in both the science and the implementation of this technology across multiple sites is proving that not only is it feasible, but it's also scalable. And we're sharing this knowledge with flagship programs across the country as strategic advisors.

    我們在多站點這項技術的科學和實施方面的領導地位證明,它不僅可行,而且具有可擴展性。我們作為策略顧問與全國各地的旗艦項目分享這些知識。

  • Our approach to newborn screening enables standardized interpretation, a key to ensuring consistency in both access and quality across geographies. Our first-mover advantage is real, and we're already seeing the impact for growing interest among policymakers, momentum building across states, and clear signs that genomic newborn screening is becoming a reality.

    我們對新生兒篩檢的方法可以實現標準化解釋,這是確保跨地區獲取和品質一致性的關鍵。我們的先發優勢是真實存在的,我們已經看到了政策制定者日益增長的興趣、各州日益增強的勢頭以及新生兒基因組篩檢正在成為現實的明顯跡象。

  • With a continued momentum and growth in our core exome and genome testing business, we announced our plans to acquire Fabric Genomics, a pioneer in AI-powered genomic interpretation. With the addition of Fabric Genomics, we will open a supplemental channel to extend the clinical excellence of GeneDx's data, analysis, and interpretation by delivering decentralized interpretation informed by our centralized intelligence.

    隨著我們核心外顯子組和基因組檢測業務的持續發展和成長,我們宣布了收購人工智慧基因組解釋領域的先驅 Fabric Genomics 的計劃。隨著 Fabric Genomics 的加入,我們將開闢一個補充管道,透過提供由我們的集中智能提供的分散解釋,擴展 GeneDx 數據、分析和解釋的臨床卓越性。

  • We are optimistic about the strategic fit of this acquisition, which will also unlock scalable platform economics for GeneDx's bottom line, adding a recurring software-based revenue stream to our existing high-margin testing business.

    我們對此次收購的策略契合度持樂觀態度,它也將為 GeneDx 的獲利釋放可擴展的平台經濟,為我們現有的高利潤測試業務增加經常性的基於軟體的收入來源。

  • As genomic testing adoption grows worldwide, Fabric Genomics' cloud-native platform will expand GeneDx's ability to serve a global market with tailored commercial models aligned with foreign regulations. And with Fabric Genomics' decentralized interpretation architecture, we will layer on an incremental offering for the NICU with the Interpretation as a service product plugin for in-house testing.

    隨著基因組檢測在全球的普及,Fabric Genomics 的雲端原生平台將擴展 GeneDx 服務全球市場的能力,並提供符合國外法規的客製化商業模式。借助 Fabric Genomics 的分散式解釋架構,我們將為 NICU 提供增量服務,並將解釋作為服務產品插件進行內部測試。

  • These supplemental opportunities support our mission of offering genetic diagnoses to all patients who could benefit with additional flexibility in how we reach those patients both domestically and internationally. Beyond the Fabric Genomics acquisition, GeneDx is integrating AI across our business with a focus on making our enterprise as efficient as possible, scaling our interpretation platform and data asset while ensuring accuracy, and leveraging the totality of our data to drive healthcare innovation more broadly.

    這些補充機會支持了我們的使命,為所有患者提供基因診斷,使他們能夠更靈活地接觸國內外患者。除了收購 Fabric Genomics 之外,GeneDx 還將人工智慧融入我們的業務中,重點是使我們的企業盡可能高效,在確保準確性的同時擴展我們的解釋平台和數據資產,並利用我們的全部數據更廣泛地推動醫療保健創新。

  • Only 5% of rare diseases have an approved therapy available. And as more biopharma companies invest in genetic-based care, our rich data is critical to inform drug discovery; and we will be the partner of choice to leverage genomic data for therapeutic development.

    只有 5% 的罕見疾病有核准的治療方法。隨著越來越多的生物製藥公司投資於基於基因的治療,我們豐富的數據對於藥物研發至關重要;我們將成為利用基因組數據進行治療開發的首選合作夥伴。

  • For the families, every patient deserves a care plan upon diagnosis, and AI can help us deliver on that. Whether the path forward for a newly diagnosed patient is a drug, physical or cognitive therapy, dietary change, or other changes in medical management, our AI technology will help us route patients on the right care path immediately at diagnosis.

    對於家庭來說,每個病人在確診後都應該得到一份護理計劃,而人工智慧可以幫助我們實現這一點。無論新診斷患者的治療方案是藥物治療、物理或認知療法、飲食改變或其他醫療管理變化,我們的人工智慧技術都將幫助我們在診斷後立即為患者引導正確的護理路徑。

  • Central to our success is the value that we create for families and for the healthcare system as a whole. We have the rare ability to drive better clinical outcomes for those with genetic disease while also relieving the healthcare system of unnecessary costs.

    我們成功的核心是我們為家庭和整個醫療保健系統創造的價值。我們擁有罕見的能力,可以為患有遺傳疾病的人帶來更好的臨床結果,同時減輕醫療保健系統不必要的成本。

  • Further strengthening our model is that we can do this as a profitable company, ensuring that we can purposefully reinvest in our technology and continue to deliver the highest quality product. We can do it better, faster, and more cost-effectively than any other lab in our space.

    進一步加強我們的模式是,我們可以作為一家盈利的公司做到這一點,確保我們可以有目的地重新投資於我們的技術並繼續提供最高品質的產品。我們可以比我們領域的任何其他實驗室做得更好、更快、更經濟。

  • With that, I'll turn it over to Kevin.

    說完這些,我就把麥克風交給凱文。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Good morning, everyone. Thanks for your time. First-quarter 2025 revenues were $87.1 million. Exome and genome revenues grew 62% year over year, contributing $71.4 million this quarter. Exome and genome accounted for 40% of all tests in the first quarter, with volumes from these flagship products up 24% year over year.

    大家早安。感謝您的時間。2025 年第一季營收為 8,710 萬美元。外顯子組和基因組營收年增 62%,本季貢獻 7,140 萬美元。外顯子組和基因組佔第一季所有測試的 40%,這些旗艦產品的數量年增 24%。

  • March, as a standalone month, saw an acceleration in volumes relative to the first two months of the year and exited the quarter ahead of expectation, bringing us into Q2 with a strong foundation to continue momentum. In fact, if not for the effects of a brutal January and February climate change disruption, volumes would have been slightly up compared to Q4 despite typical seasonality, which usually results in Q4 being the strongest and Q1 the lightest of any quarter of the year. I should also note that calendar-wise, Q1 had one less sales day compared to the fourth quarter.

    3 月作為一個獨立月份,其交易量相對於今年前兩個月有所加速,並且提前結束了本季度,為我們進入第二季度奠定了繼續保持良好勢頭的堅實基礎。事實上,如果不是受到 1 月和 2 月氣候變遷的嚴重影響,儘管存在典型的季節性因素,通常第四季度是一年中任何季度中最強勁的,而第一季則是最淡的,但與第四季度相比,產量仍會略有上升。我還應該指出,從日曆上看,第一季的銷售日比第四季少一天。

  • In addition to growing off the base we delivered to start the year, we'll be layering on what will effectively be new growth curves across multiple fronts, including the NICU, and with new indications in both the pediatric and adult outpatient settings. We've continued to balance demand from a clinical standpoint with discipline, targeting volume with a high propensity to get paid rather than taking in volume for volume's sake.

    除了在年初的基礎上實現成長之外,我們還將在多個方面拓展新的成長曲線,包括新生兒加護病房 (NICU),並在兒科和成人門診環境中推出新的適應症。我們一直從臨床的角度和紀律平衡需求,以數量為目標,傾向於獲得高額報酬,而不是為了數量而數量。

  • That said, we've launched into some new focus areas for our commercial team, most recently immune deficiency disorders in April, which is a new call point, that being the pediatric immunologist. Compare that to cerebral palsy launched earlier in March, which you can consider another indication in the bag at an existing call point, the pediatric neurologist. We'll be closely monitoring uptake and reimbursement performance as adjudication experience accumulates.

    也就是說,我們已經為我們的商業團隊開展了一些新的重點領域,最近一次是四月份的免疫缺陷疾病,這是一個新的呼叫點,即兒科免疫學家。與 3 月初推出的腦性麻痺治療相比,您可以將其視為現有呼叫點的另一個適應症,即兒科神經科醫生。隨著裁決經驗的積累,我們將密切監測吸收和報銷情況。

  • And the NICU remains mostly untapped. Our ultraRapid became orderable in April and is being well-received in terms of its two-day turnaround time and price point. We'll be exiting the pilot phase of Epic Aura in May and also bringing new compelling health economic data to the field in the coming weeks to drive this market.

    新生兒加護病房 (NICU) 的大部分功能仍未開發。我們的 ultraRapid 於四月開始接受訂購,其兩天的周轉時間和價格都廣受歡迎。我們將於 5 月結束 Epic Aura 的試點階段,並在未來幾週內為該領域帶來新的引人注目的健康經濟數據,以推動這一市場的發展。

  • We're addressing a large unmet medical need here, and the progress to expand access to testing across a widening spectrum of conditions is underpinned by our ability to provide valuable service to biopharma, leveraging our unique data assets to enable faster, cheaper, more effective therapeutic development. What has been a nascent biopharma business for us is still in the very early innings, but it is beginning to gain traction. We're demonstrating to partners that rare disease isn't rare and that GeneDx is in a unique position to find patients, reduce development time and costs, and improve probability of success.

    我們正在解決大量未滿足的醫療需求,擴大在越來越廣泛的條件下進行檢測的機會的進展,得益於我們為生物製藥提供寶貴服務的能力,利用我們獨特的數據資產實現更快、更便宜、更有效的治療開發。對我們來說,生物製藥業務尚處於起步階段,但它已開始獲得發展動力。我們向合作夥伴證明罕見疾病並不罕見,GeneDx 在尋找患者、減少開發時間和成本以及提高成功率方面具有獨特的優勢。

  • In terms of reimbursement, the hard work to reduce denials continues to bear fruit. And you see that in the underlying rates and continued positive beats on past estimates. In the first quarter, average reimbursement rate for exome and genome after all denials was approximately $3,400, up from approximately $2,600 in the same quarter last year. On the Medicaid front, there are 14 states that cover rapid genome inpatient and now 33 states covering exome and or genome outpatient with New Mexico, the new add this quarter.

    在報銷方面,減少拒付的努力持續取得成效。您可以從基本利率和過去估計值的持續正成長中看到這一點。第一季度,所有拒絕後的外顯子組和基因組平均報銷率約為 3,400 美元,高於去年同期的約 2,600 美元。在醫療補助方面,有 14 個州涵蓋快速基因組住院患者,現在有 33 個州覆蓋外顯子組和/或基因組門診患者,新墨西哥州是本季度新增的。

  • Adjusted gross profit from continuing operations in the first quarter was $59.7 million, which is up 56% year over year. That translates to an adjusted gross margin of 69% in the first quarter, up from 61% a year ago.

    第一季調整後持續經營毛利潤為 5,970 萬美元,年增 56%。這意味著第一季調整後的毛利率為 69%,高於去年同期的 61%。

  • We entered this year focused on extracting the next leg of scalability and cost effectiveness through the introduction of automation and AI across the dry lab processes. While the team is making steady organic development progress here, our optimism regarding further cost efficiency is only enhanced with the pending acquisition of Fabric.

    今年,我們專注於透過在幹實驗室流程中引入自動化和人工智慧來實現下一階段的可擴展性和成本效益。雖然團隊在這裡正在穩步推進有機發展,但隨著 Fabric 的收購即將完成,我們對進一步提高成本效率的樂觀情緒只會增強。

  • Over time, we envision taking the best of features and technology between our homegrown platform and fabrics in order to create the most powerful AI-driven interpretation platform possible to lower costs and turnaround times. The impact of these synergies should be considered more of a 2026 into 2027 events as commercial integration and support will be our focus for the balance of the year.

    隨著時間的推移,我們設想利用我們自主研發的平台和布料之間的最佳功能和技術,以創建最強大的人工智慧驅動的解釋平台,從而降低成本和周轉時間。這些協同效應的影響應該更多地被視為 2026 年至 2027 年的活動,因為商業整合和支持將是我們今年剩餘時間的重點。

  • And down to the bottom line, adjusted net income for the first quarter 2025 was $7.7 million, our third consecutive quarter of profitability as we continue to drive increased leverage in operating expense to service the business.

    具體來說,2025 年第一季的調整後淨收入為 770 萬美元,這是我們連續第三個季度實現盈利,因為我們繼續提高營運費用的槓桿率來服務業務。

  • On the balance sheet, cash, cash equivalents, marketable securities, and restricted cash total $160.2 million as of March 31, 2025. Cash flow for the first quarter included $4.1 million in net cash generated from ordinary operations and $13.9 million in proceeds, net of fees, from the issuance of 150,000 shares of common stock in connection with ATM sales.

    資產負債表上,截至 2025 年 3 月 31 日,現金、現金等價物、有價證券及受限現金總額為 1.602 億美元。第一季的現金流量包括來自普通經營的淨現金 410 萬美元,以及 ATM 銷售相關發行 15 萬股普通股的收益(扣除費用)1,390 萬美元。

  • Now turning to guidance. We're raising our top-line guidance to now expect total revenues between $360 million and $375 million for full year 2025 inclusive of $3 million to $5 million post-closed revenue contribution from the acquired Fabric business. That's assuming a second quarter 2025 post.

    現在轉向指導。我們提高了營收預期,目前預計 2025 年全年總收入將在 3.6 億美元至 3.75 億美元之間,其中包括收購 Fabric 業務後 300 萬至 500 萬美元的收入貢獻。這是假設 2025 年第二季發布。

  • We reaffirm our expectation to deliver at least 30% growth in exome and genome volume and revenues for full year 2025. We're raising our expectation for full year 2025 adjusted gross margin to between 66% and 68%. And we reaffirm our expectation to maintain profitability each quarter and for the full year of 2025 on an adjusted net income basis.

    我們重申我們的期望,即到 2025 年全年外顯子組和基因組的數量和收入將增加至少 30%。我們將 2025 年全年調整後毛利率預期上調至 66% 至 68% 之間。我們重申我們的期望,在調整後的淨收入基礎上保持每季和 2025 年全年的利潤。

  • I'll hand you back to Katherine for any closing remarks.

    我將把您交還給凱瑟琳,請她做最後的總結發言。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Q1 marked our third consecutive quarter of profitability, reinforcing the strength and scalability of our business model. Through disciplined execution and strategic investment, we're growing with purpose, accelerating our impact while extending our lead.

    第一季是我們連續第三個季度實現盈利,增強了我們商業模式的優勢和可擴展性。透過嚴格的執行和策略投資,我們正在有目的地成長,在擴大領先地位的同時加速我們的影響力。

  • This quarter also marked our 25th anniversary, offering a powerful moment to reflect on the 800,000 exomes and genomes we've sequenced, patients we've helped, and the scientific breakthroughs we've delivered. But the real story is what's ahead.

    本季也是我們成立 25 週年,這是一個重要的時刻,讓我們回顧我們測序的 80 萬個外顯子組和基因組、我們幫助過的患者以及我們取得的科學突破。但真正的故事還在後面。

  • We're turning decades of progress into a foundation for what comes next. The future of healthcare is about preventing illness. That means knowing as early as possible if you have a genetic disease. This is the genome future, and we are leading the way.

    我們正在將數十年的進步轉化為未來的基礎。醫療保健的未來在於預防疾病。這意味著要儘早知道自己是否患有遺傳疾病。這是基因組的未來,我們正在引領這個方向。

  • With that, we look forward to your questions.

    我們期待您的提問。

  • Operator

    Operator

  • (Operator Instructions) Bill Bonello, Craig Hallum Capital Group.

    (操作員指示)Craig Hallum Capital Group 的 Bill Bonello。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Not to take away from what was, in our opinion, an overall very good quarter. The focus this morning's obviously going to be on the volume growth. And the color and the weather and the days in the quarter was super helpful.

    我們認為,這整體上是一個非常好的季度。今天早上的焦點顯然是交易量的增長。該季度的顏色、天氣和日子都非常有用。

  • I'm just curious. We've absolutely seen over time that Q1 is the toughest volume quarter for almost every lab, so that sequential trend is pretty normal. But we haven't necessarily seen it for GeneDx before, and we've never seen a sequential decline before.

    我只是好奇。隨著時間的推移,我們已經看到,第一季幾乎是每個實驗室工作量最大的一個季度,因此這種連續趨勢非常正常。但我們之前並未見過 GeneDx 出現這種情況,而且我們之前也從未見過連續下降的情況。

  • I'm just curious. Do you think that's a function of the fact that you were just growing really rapidly off a low base in the past? I mean, why -- and that maybe masks the normal trend. I mean, why do we see the trend now when we might not have in the past? And then a couple follow-ups if I can.

    我只是好奇。您是否認為這是因為你們過去在低基礎上實現了快速成長?我的意思是,為什麼——這也許掩蓋了正常趨勢。我的意思是,為什麼我們現在看到這種趨勢,而過去可能沒有看到?如果可以的話,我會進行一些後續跟進。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yeah. Look, historically -- and as a reminder, I've been with the company eight years. There absolutely is a historic pattern of Q4 into Q1, a step down in volumes.

    是的。看看歷史——提醒一下,我已經在公司工作八年了。從第四季到第一季度,交易量確實有一個下降的歷史模式。

  • What you typically see, absent any weather events, is patients and their physicians trying to get appointments squeezed into the month of December before co-pays and deductibles naturally reset for most patients on January 1. And so that has a pull-through effect into January and February despite weather. There's no doubt.

    通常情況下,如果沒有天氣事件,患者和他們的醫生會試圖在 12 月擠出時間預約,以便在 1 月 1 日大多數患者的共同支付和免賠額自然重置之前完成預約。因此,無論天氣如何,這都會對 1 月和 2 月產生拉動動作用。毫無疑問。

  • The way the calendar plays out this year, there's actually just one less day available to it. And there's no doubt that early in the year, January into mid-February, it's just a tough setup in terms of the wildfires in California, snowstorms throughout the Midwest and all over the country.

    從今年日曆的安排來看,可用的時間實際上只少了一天。毫無疑問,從年初 1 月到 2 月中旬,加州的野火、中西部和全國各地的暴風雪,對經濟來說都是嚴峻的考驗。

  • I think there is something to, of course, the fact that we're coming off a smaller base in the prior year. We obviously blew past seasonality then.

    當然,我認為這與去年我們的基數較小有關。顯然,我們已經超越了季節性。

  • The way we look at the first quarter is it played out exactly as we expected. Our guide, we reaffirmed the plus 30% in terms of volume, absolutely maintains and is intact. And consistent with discussions last quarter, I'll remind everyone that the plan was purposely built to say the second half of the year will be stronger than the first, really just in timing of new initiatives and launches we have planned.

    我們認為第一季的進展正如我們預期的那樣。我們的指南,我們重申了體積方面的加 30%,絕對保持完好無損。與上個季度的討論一致,我要提醒大家,該計劃的目的是表明下半年將比上半年更加強勁,實際上只是為了配合我們計劃的新舉措和新發布的時機。

  • So we spoke to some of those in terms of color in the commentary. Good progress in setting all the foundational pieces for the NICU, whether it was a buckle swab launch in Q4, the ultraRapid, which really just became orderable in April after this first quarter. So it's got the two day turnaround time and a great price point to it. That really is just an April event.

    因此我們在評論中從顏色的角度討論了其中的一些問題。新生兒加護病房 (NICU) 所有基礎零件的設定都取得了良好進展,無論是第四季度推出的扣環拭子,還是在第一季之後的 4 月才真正開始接受訂購的 ultraRapid。因此它的周轉時間為兩天,而且價格也很優惠。那其實只是四月的一個活動。

  • And we're making great progress with the Epic Aura implementation, exiting pilot phase here. And so ready to launch and tackle the NICU. I had always signaled that the second half of the year ramp. And we'll see some volumes late in the second quarter, but it's really a ramp in the second half of the year and beyond. And that absolutely remains right on track.

    我們在 Epic Aura 實施方面取得了巨大進展,並已結束試點階段。並準備啟動和解決 NICU 問題。我一直暗示下半年會出現成長。我們將在第二季末看到一些交易量,但這實際上是今年下半年及以後的一個上升趨勢。這絕對是正確的。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • That's super helpful. And then just a completely different question, a follow up. But there was a big bump in G&A expense. And you guys had been signaling that operating expense, we should look for it to increase a little bit. But anything particular on the G&A front, I don't know if that's related to Epic or if there's any unusual items, et cetera, that we should know about?

    這非常有幫助。然後是一個完全不同的問題,一個後續問題。但一般及行政費用卻大幅增加。你們一直在暗示,我們應該期待營運費用有一點增加。但是在 G&A 方面有什麼特別的事情嗎?我不知道這是否與 Epic 有關,或者是否有任何我們應該知道的不尋常的項目等等?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yeah. A good portion is Epic as well as general support costs. Considering the pace in which we're growing, looking at the percentages of total OpEx and then the components, absolutely comfortable that -- we've always viewed this as a highly leverageable business in terms of OpEx.

    是的。很大一部分是 Epic 以及一般支援成本。考慮到我們的成長速度,看看總營運支出的百分比及其組成部分,我們絕對感到放心——就營運支出而言,我們一直認為這是一項可高度利用的業務。

  • And with the introduction of new team members and, importantly, tools and automation across the organization, fully expect that we'll continually drive down OpEx as a percent of revenue in a meaningful way for quite a long period to come. Overall, the Epic infrastructure, we've always signaled about $5 million plus costs in the G&A line alone on an annual basis.

    隨著新團隊成員的加入,以及更重要的整個組織的工具和自動化,我們完全有信心在未來相當長的一段時間內,我們將持續以有意義的方式降低營運支出佔收入的百分比。總體而言,Epic 基礎設施每年僅在 G&A 方面的成本就約為 500 萬美元以上。

  • Operator

    Operator

  • Dan Brennan, TD Cowen.

    丹布倫南 (Dan Brennan),TD Cowen。

  • Dan Brennan - Analyst

    Dan Brennan - Analyst

  • Maybe just starting on the NICU for the back half of the year. Kevin and Katherine, could you speak to a little bit like what the visibility is that supports the second half acceleration, whether a backlog or sales feedback, anything of that sort? And if you can include some early feedback from Epic Aura so far, since it's already been out, I guess, in the pilot stage.

    也許下半年就開始在新生兒加護病房 (NICU) 工作了。凱文和凱瑟琳,你們能否稍微談談支持下半年加速發展的可見性,無論是積壓訂單還是銷售回饋,諸如此類?並且您是否可以提供一些 Epic Aura 目前的早期回饋,因為它已經推出,我想,處於試點階段。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Yeah. So far, Dan, everything is on track with Epic Aura. We're really pleased with our initial integration. And the sales team has been -- I think we've talked about this in the past. We had a waiting room of clients that are lined up.

    是的。丹,到目前為止,Epic Aura 的一切都很順利。我們對最初的整合感到非常滿意。銷售團隊一直——我想我們過去已經討論過這個問題了。我們有一個等候室,裡面有排隊等候的顧客。

  • So we've got a really solid approach to being able to make sure that we can continue to bring additional clients online and start driving volume in. The first integration has gone on track, and it's been -- we've had a lot of good learnings that we can apply into the others to ensure that they can move rapidly as well.

    因此,我們有一個非常可靠的方法來確保我們能夠繼續吸引更多客戶上線並開始增加交易量。第一次整合已經步入正軌,我們已經獲得了很多有益的經驗,可以應用到其他整合中,以確保它們也能快速發展。

  • Dan Brennan - Analyst

    Dan Brennan - Analyst

  • Okay. Maybe on pricing. So Kevin, almost $3,500 in the first quarter, ex the prior period, maybe closer to like $3,100, $3,200. How should we think about pricing playing out like in Q2 and for the rest of the year? And can you discuss potential levers for upside?

    好的。也許是定價方面。因此,凱文,第一季的收入接近 3,500 美元,扣除前期,可能接近 3,100 美元或 3,200 美元。我們該如何看待第二季以及今年剩餘時間的定價走勢?您能討論一下潛在的上漲槓桿嗎?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yeah. And I think it's important to note maybe the distinction between those true-up estimates versus anything that might be considered one time or discrete. Go back to the fourth quarter, we had what we signaled was a discrete benefit in the fourth quarter, that being a bit of a special multi-year and very material appeal win from one of the large national payers.

    是的。我認為,重要的是要注意這些真實估計值與任何可能被視為一次性或離散的估計值之間的差異。回到第四季度,我們表示,第四季度獲得了一項獨立收益,這是一項來自大型國家付款人的特殊多年期且非常重要的吸引力勝利。

  • I view that very differently than ordinary course true ups in estimates. Frankly, the gap calculations take a six-month look back, disaggregating to really get to an estimated cash collection position. And what that means in reality is every month, we're dropping off an older month from six months ago in that calculation and picking up a newer month.

    我認為這與通常的估算非常不同。坦白說,差距計算需要回顧六個月,分解才能真正得到估計的現金收款情況。這實際上意味著每個月,我們在計算時都會去掉六個月前的一個較舊的月份,然後選擇一個較新的月份。

  • And so those calculations will pick up estimate changes or true ups or, frankly, true downs in periods where collections are not meeting previous estimates. What you've now seen from us is I think it's six quarters, something around there, of positive true-up adjustments running through any quarter. This quarter was no difference, roughly $6 million.

    因此,這些計算將會捕捉到估計值的變化或真實的上升,或者坦白說,在收款額未達到先前估計值的時期內的真實下降。您現在從我們這裡看到的是,我認為大約有六個季度,每個季度都會出現正向的真實調整。本季沒有什麼變化,大約 600 萬美元。

  • And I don't consider that to be discrete or non-recurring, which is why we didn't call it out as such, but more so an indication that we remain in a prevailing period of improving the revenue cycle to reduce denials and every month dropping off an older month where we were collecting less than we are today.

    我並不認為這是離散的或非經常性的,這也是為什麼我們沒有這樣稱呼它,而更多的是表明我們仍然處於改善收入周期的主導時期,以減少拒絕,並且每個月都會減少一個舊月份的收入,而我們的收入比現在要少。

  • And so consistent with maybe some past comments on where to take that reimbursement rate from an outlook perspective moving forward, I think it's the new floor in which we're going to continue to build off of versus expecting something lower to hit next quarter in terms of a sharp drop off, not being able to rely on those true ups.

    因此,與過去關於從未來前景角度看報銷率應如何提高的一些評論一致,我認為這是我們將繼續在此基礎上繼續提高的新底線,而不是預期下個季度會出現更低的水平,出現急劇下降,不能依賴這些真正的上漲。

  • We've had them pretty consistently in this range of $3 million to $7 million every quarter. And I think we're still in the mid- to early innings of improving the overall revenue cycle, still getting paid only about half of the time -- a little bit more than half of the time now on insurance adjudicated claims.

    我們每季的支出都穩定在 300 萬至 700 萬美元的範圍內。我認為我們仍處於改善整體收入週期的中早期階段,仍然只有大約一半的時間能夠獲得賠償——目前在保險裁決索賠方面,只有一半多一點的時間能夠獲得賠付。

  • And we think that's nowhere near optimized and normal with the vast majority of denials still coming in as administrative or procedural denials. And so things that I would call within our control to rectify and fix through engaging with payers.

    我們認為這遠未達到最佳化和正常水平,絕大多數拒絕仍然是行政或程序拒絕。因此,我認為我們可以透過與付款人接觸來糾正和解決我們控制範圍內的事情。

  • And so that hard work is going to continue, which should further lead to a reduction in denials and overall improvements in that average reimbursement rate going forward.

    因此,我們將繼續努力,以進一步減少拒付,並全面提高未來的平均報銷率。

  • Dan Brennan - Analyst

    Dan Brennan - Analyst

  • Maybe we're going to sneak in with one or two quick ones. You talked about a strong March and a good start to the quarter. Any color on how April has gone?

    也許我們會偷偷地快速地做一兩件事。您談到了三月份的強勁表現和本季的良好開端。四月過得怎麼樣?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yeah. Momentum has carried forward. March and April playing out as expected, which certainly plays into the expectation seasonally that we're now through the bad weather months. We're through that carryover effect of people pulling appointments into December before co-pays and deductibles.

    是的。勢頭繼續向前發展。三月和四月的情況正如預期,這當然符合人們的季節性預期,即我們已經度過了惡劣天氣的月份。我們已經度過了人們在共同支付和免賠額之前將預約推遲到 12 月的延續效應。

  • Volume playing out as expected, which led us to the conviction that we should reaffirm our guide, which was a full year plus 30% or higher on volumes.

    交易量正如預期的那樣,這讓我們確信我們應該重申我們的指導方針,即全年交易量將增加 30% 或更高。

  • Dan Brennan - Analyst

    Dan Brennan - Analyst

  • Great. And then just final one. You talked about newborn screening and pharma in the prepared remarks. When could those become part of the revenue stream here? Is it '25, '26? Just any visibility on that.

    偉大的。接下來就是最後一個了。您在準備好的演講中談到了新生兒篩檢和製藥業。這些什麼時候才能成為這裡的收入來源的一部分?是 '25、'26 嗎?只要能看見這一點即可。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Yeah. I think for newborn screening, we're seeing legislation in Florida that has been introduced and has made it, I think, through the house. But from a broader perspective, we see newborn screening as being a contributor to revenue streams, most likely, in the '27 timeframe.

    是的。我認為,對於新生兒篩檢,我們看到佛羅裡達州已經提出立法,我認為已經在眾議院獲得通過。但從更廣泛的角度來看,我們認為新生兒篩檢很有可能在 27 年期間成為收入來源的貢獻者。

  • Unlikely before that, there could be some possibilities as we think about the Fabric opportunity and how we might be able to bring on some revenue through those sorts of efforts, but those are going to be smaller efforts in the beginning.

    在此之前不太可能,當我們考慮 Fabric 的機會以及如何透過這些努力帶來一些收入時,可能會有一些可能性,但這些努力在開始時會比較小。

  • I think we're just really encouraged to see states taking action. Like Florida, they're really trying to set the model to get ahead of disease manifestation. So I would keep expectations super modest on newborn screening until we really start to see some traction out there.

    我認為看到各州採取行動我們感到非常鼓舞。就像佛羅裡達州一樣,他們確實在努力樹立榜樣,以預防疾病的發生。因此,在我們真正開始看到一些進展之前,我對新生兒篩檢的期望值不會太高。

  • Operator

    Operator

  • Mark Massaro, BTIG.

    BTIG 的馬克馬薩羅。

  • Mark Massaro - Analyst

    Mark Massaro - Analyst

  • I wanted to start on Fabric genomics. So my understanding is that this provides another revenue opportunity for you with interpretation as a service. Can you just give us a sense for how you're thinking about pricing these services or these interpretations? Can you speak to the gross margin profile if they might be accretive to where you are today?

    我想開始研究 Fabric 基因組學。因此,我的理解是,這為您提供了另一個透過口譯即服務創造收入的機會。您能否告訴我們您是如何考慮為這些服務或解釋定價的?您能否談談毛利率狀況,看看它是否會對您目前的狀況產生影響?

  • And then I saw that you maintained the profitability on an adjusted net income basis each quarter this year, which is great. I just want to get a sense for what the potential cash burn might look like for Fabric this year.

    然後我看到你們今年每季都保持了調整後淨收入的獲利能力,這很好。我只是想了解一下今年 Fabric 的潛在現金消耗。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Sure. So I'll start and then hand it over to Kevin. So I think part of what excites us about Fabric is its ability to really help us continue to provide a valuable service, putting our data into their interpretation platform for any health system that wants to do their own in-house sequencing. And we've seen that over the past few years, and we continue to see it as an opportunity moving forward.

    當然。所以我先開始,然後把它交給凱文。因此,我認為 Fabric 令我們興奮的部分原因是它能夠真正幫助我們繼續提供有價值的服務,將我們的數據放入他們的解釋平台,供任何想要進行內部測序的醫療系統使用。我們在過去幾年中已經看到了這一點,我們將繼續將其視為向前發展的機會。

  • So it enables us to really play a part in that from a service and from an economic standpoint. Furthermore, it helps us on the international capability where we can essentially expand into international markets very cost-effectively and in a way that complies with foreign regulations.

    因此,它使我們能夠從服務和經濟的角度真正發揮作用。此外,它還幫助我們提高國際能力,使我們能夠以非常經濟高效的方式並符合外國法規的方式擴展到國際市場。

  • But then again, as we see newborn screening coming on board as well, that Florida opportunity that I mentioned, that gives us the opportunity to be able to help them accelerate it and have standardized interpretation. So we're really excited about what the acquisition of this asset can mean to accelerate the business. I'll let Kevin comment on the economics of it.

    但話說回來,正如我們所看到的,新生兒篩檢也正在加入進來,我提到的佛羅裡達州的機會,讓我們有機會幫助他們加速這一進程並進行標準化的解釋。因此,我們對收購這項資產對加速業務發展的意義感到非常興奮。我會讓凱文對其經濟性進行評論。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yeah. From an overall profile perspective, very different model, of course, than the full-service GeneDx lab. Today, that Fabric business operates at near 70% gross margin, and that's through either interpretation as a service or software as a service.

    是的。從整體概況來看,當然,與提供全方位服務的 GeneDx 實驗室相比,該模式非常不同。如今,Fabric 業務的毛利率接近 70%,這是透過解釋即服務或軟體即服務來實現的。

  • So think of highly recurring sticky revenue streams, certainly at a lower dollar point than a full diagnostic test that we offer. But with that lower price point also comes the fact that that business is not bearing the cost of running a facility, operating a wet lab, reagent costs -- really just providing click services from a software perspective and or dry side interpretation and analysis to deliver a report.

    因此,想想高度經常性的黏性收入流,其成本肯定比我們提供的全面診斷測試要低。但較低的價格也意味著該企業無需承擔營運設施、濕實驗室和試劑的成本——實際上只是從軟體角度提供點擊服務或乾側解釋和分析以提供報告。

  • So high margin, but of course, a bit -- the model to be a bit more recurring and high volume. From a burn profile, a couple million dollars a quarter. It's 22 people in terms of the overall size of the workforce. We will begin integration activities once we close on the deal, which we expect in the second quarter.

    利潤率很高,但當然,模型有點更具重複性,而且容量更大。從燒錢情況來看,每季有幾百萬美元。就員工總數而言,共有 22 人。一旦我們完成交易,我們將開始整合活動,預計在第二季完成。

  • I think where we see immediate opportunity is there really has not been any meaningful commercial investments into selling the product. And so the team has accumulated a great set of clients and logos. If you look at the existing customer base, very impressive client base, but very much undersized with respect to commercial might.

    我認為我們看到的直接機會是,實際上還沒有任何有意義的商業投資來銷售該產品。因此,該團隊累積了大量的客戶和標誌。如果你看看現有的客戶群,你會發現客戶群非常令人印象深刻,但就商業實力而言,規模遠遠不足。

  • And we're optimistic that the GDX capabilities with respect to commercialization can pull through into certainly a higher revenue base, but also have a expanding effect on gross margins; and confident that the deal is accretive to us on the bottom line in 2026.

    我們樂觀地認為,GDX 在商業化方面的能力不僅可以帶來更高的收入基礎,而且還會對毛利率產生擴大的影響;並相信這筆交易將在 2026 年為我們帶來利潤成長。

  • Mark Massaro - Analyst

    Mark Massaro - Analyst

  • Excellent, that's very helpful. And then, I wanted to ask. It sounds like you've got ultraRapid orderable here in April. Either you just launched that or -- I would assume you just launched it. But bottom line here, were you factoring in ultraRapid into your guidance when you provided the guide on the Q4 call? Or do you think there could be upside from ultraRapid in the back half of this year to the guidance?

    非常好,非常有幫助。然後,我想問一下。聽起來您四月可以在這裡訂購 ultraRapid。要么你剛剛啟動了它,要么——我認為你剛剛啟動了它。但底線是,當您在第四季度電話會議上提供指南時,是否將 ultraRapid 考慮在您的指導中?或者您認為今年下半年 ultraRapid 的業績可能會超出預期嗎?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • We contemplated it in the original guide, but of course, always with the back half of the year. So nothing contemplated in the original guide for Q1 or Q2. There's a bit of an education process out in the field. We've now worked through that. The test has been orderable here just for a few weeks.

    我們在原始指南中考慮過這個問題,但當然,總是在下半年。因此,原始指南中沒有考慮 Q1 或 Q2 的內容。在這個領域有一些教育過程。現在我們已經解決了這個問題。幾週前,我們就已經在這裡接受過該測試的訂購。

  • I think the upside would come in what we see as ultimate mix between the ultraRapid or what today I'll call Rapid. And so we have two product lines now for the NICU. One is the two-day turnaround time at a premium price point; the other is a five-day turnaround time at a lower price point. We actually believe that the price point there on both products is best in class in terms of offering cost back to clients.

    我認為,好處在於,我們看到了超快速 (ultraRapid) 或我今天稱之為快速 (Rapid) 的終極混合體。因此,我們現在有兩條針對 NICU 的產品線。一是高價位的兩天週轉時間;另一種是五天的周轉時間,價格較低。我們確實相信,從為客戶提供成本回報的角度來看,這兩款產品的價格都是同類產品中最好的。

  • And so the upside would be if we see ultraRapid take more than expected mixed share over the five-day turnaround time, there'd be some pricing benefits there.

    因此,如果我們看到 ultraRapid 在五天的周轉時間內佔據比預期更多的混合份額,那麼就會有一些定價優勢。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Yeah, and I would just say on the NICU opportunity, it's all of the product attributes in addition to Epic Aura. So Epic Aura is an enabler. But being able to have that five-day turnaround, the 48-hour turnaround; being able to ensure that the reports coming out are coming with a very clear care plan for the neonatologist and the family. It's that full suite of services that is going to be the reason that we're winning in the NICU.

    是的,我只想說,關於 NICU 機會,除了 Epic Aura 之外,它還具有所有產品屬性。因此 Epic Aura 是一種推動因素。但能夠實現五天、四十八小時的周轉時間;能夠確保報告附帶針對新生兒科醫生和家庭的非常明確的護理計劃。正是這全套服務才是我們在新生兒加護病房取得成功的原因。

  • So Epic is one piece, turnaround time's another piece. But it's that full end-to-end service that is going to enable us to realize that opportunity. And again, fewer than 5% of babies today are getting a genetic test. So it's a huge area of focus for us, and it's that all-in service and product strategy that we've got that's going to ensure that we're able to really deliver value in that setting.

    因此,Epic 是一回事,週轉時間又是另一回事。但正是這種完整的端到端服務使我們能夠實現這一機會。而目前只有不到 5% 的嬰兒接受基因檢測。因此,這是我們關注的一個重點領域,而我們所擁有的全方位服務和產品策略將確保我們能夠在這種環境中真正實現價值。

  • Mark Massaro - Analyst

    Mark Massaro - Analyst

  • Okay, great. And then maybe one last one for me. I guess, Kevin, do you have a sense -- apologies if I missed it, but do you have a sense for roughly what the weather impact was from the snowstorms and the wildfires in one less day?

    好的,太好了。這對我來說也許是最後一個了。我想,凱文,你有沒有感覺到——如果我沒注意到,請原諒,但你是否大致知道在短短一天內,暴風雪和野火對天氣的影響有多大?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yeah. I mean, the one less day is just tangible. And so one day's worth of reports is a few hundred.

    是的。我的意思是,少了一天是切實存在的。因此,一天的報告就有幾百份。

  • From a weather perspective, look, I don't want to over or understate it. It absolutely was a reality. Did we plan on certainly terrible weather in January and February? We do. This year happened to be extraordinary in terms of actual logistical disruption. Probably worth a day or two in terms of tangible carryover for the quarter.

    從天氣角度來看,我不想誇大或低估它。這絕對是事實。我們是否預料到一月和二月的天氣一定非常惡劣?是的。就實際的物流中斷而言,今年是非同尋常的一年。就本季的實際結轉而言,可能值得花一兩天。

  • Operator

    Operator

  • Tycho Peterson, Jefferies.

    傑富瑞 (Jefferies) 的 Tycho Peterson。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • Wondering if you're able to break out what you're expecting for new indications this year. You mentioned immune deficiencies. You've got cerebral palsy. You've got hearing loss. And then, are you able to quantify where you think mix will go for ultraRapid as well?

    想知道您是否能夠透露您對今年新跡象的期望。您提到了免疫缺陷。你患有腦性麻痺。您的聽力受損了。然後,您能否量化您認為混合將如何用於 ultraRapid?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • So the blend of the new indications versus what I'll call the existing base is just all contemplated in the basket to get us to the 30% or higher guide that we just reaffirmed, which would, of course, call for something greater than the 24% we just posted in the first quarter in the second half of the year.

    因此,新指標與我所說的現有基礎的結合只是在籃子中考慮的結果,以使我們達到我們剛剛重申的 30% 或更高的指導,當然,這要求下半年的增長率高於我們剛剛在第一季度公佈的 24%。

  • I think it's a bit early to tell what the impact is. Like, we just launched immune deficiency disorders a couple weeks ago. So the team is out in the field. In either case, what we're talking about is changing standard of care and entrenched behaviors at physicians who've been ordering multi-gene panels, things like CMA.

    我認為現在判斷其影響還為時過早。例如,我們幾週前剛推出了免疫缺陷症。因此球隊已經出場了。無論如何,我們所談論的都是改變那些要求進行多基因檢測(如 CMA)的醫生的護理標準和根深蒂固的行為。

  • And so a bit too early to tell, but absolutely gives us confidence that there will be supplemental growth beyond what we've already been accumulating, which has been primarily, over the past 18 months, two years, an introduction of the new call point of pediatric neurologists.

    現在說還為時過早,但我們絕對有信心,除了現有的增長之外,還會有補充增長,這主要是在過去 18 個月、兩年內引入了兒科神經科醫生的新呼叫點。

  • Still very much a long runway of growth there. So of course, don't want to overlook the fact that we are going to continue to farm that call point, activating new docs, and driving more same-store sales from that. Really consider things like immunologists and cerebral palsy, and there'll be more throughout the year and coming years, as supplemental to that existing base, which still has a lot of opportunity to go far.

    那裡仍有很長的成長空間。因此,當然,不要忽視這樣一個事實,即我們將繼續耕耘該呼叫點,啟動新文檔,並從中推動更多的同店銷售額。認真考慮免疫學家和腦性麻痺等問題,今年和未來幾年還會有更多的問題,作為現有基礎的補充,但仍有許多機會可以走得更遠。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Yeah. And as a reminder, there's 10,000 rare diseases that we're able to diagnose. So it will continue to be just a rolling set of indications as we think about where we're going.

    是的。提醒一下,我們能夠診斷的罕見疾病有 10,000 種。因此,當我們思考我們要去哪裡時,它將繼續只是一組滾動的指示。

  • One of the things that I mentioned on the call was starting to focus on adults as well. There are many children who grew up having epileptic seizures who did not get a diagnosis who are now adults. There are adults who are starting to have seizures. So we want to make sure that we can also start helping those patients as well.

    我在電話中提到的一件事是開始關注成年人。很多孩子在成長過程中患有癲癇症,但都沒有得到診斷,現在他們已經成年了。有些成年人開始出現癲癇發作。因此我們希望確保我們也能開始幫助這些患者。

  • And with a clear tie to reimbursement, we think that's another great opportunity that we're focused on as well.

    由於與報銷有明確的聯繫,我們認為這也是我們關注的另一個絕佳機會。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • And on the ultraRapid mix question, look, we see a place in the market for both product lines. Obviously, the two-day turnaround time offers benefit for those kids that are in acute need, but there's an economic reality.

    關於超快速混合問題,我們看到這兩條產品線在市場上都有一席之地。顯然,兩天的周轉時間對於那些急需幫助的孩子來說很有幫助,但這是一個經濟現實。

  • I think we actually believe that the health economic argument in savings is actually greater with the premium price two-day product. But it's incumbent on us to now get that health economic data out into the field. And the team now has everything they need to be equipped to go have those conversations with hospital administrators and the C-suite at hospitals.

    我認為我們確實相信,高價兩天產品在節省健康經濟方面的效益實際上更大。但現在我們有責任將這些健康經濟數據推廣到實際領域。現在,該團隊已經具備了與醫院管理人員和高階主管進行對話所需的一切條件。

  • And we will be busy with that over the coming months. So too early to tell what the actual mix between the five-day and the two-day products will be with, of course, the more that drives into the two-day time provides uplift in terms of revenue at that higher price point and, at the same time, we think offers hospital systems even greater value with respect to both the clinical and economic benefits.

    未來幾個月我們將會忙於此事。因此,現在判斷五天和兩天產品之間的實際組合還為時過早,當然,兩天時間的投入越多,在更高的價格點上的收入就越高,同時,我們認為,這將為醫院系統提供更大的價值,無論是在臨床還是經濟效益方面。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • Yeah, that's what I was getting at. Could it be the majority over time for ultraRapid? Kevin, can you maybe -- just on growth margin guidance. You were 69% in the first quarter, guiding 66% to 68%. Maybe just talk about some of the gives and takes there, especially given that you're launching higher-priced products here with ultra.

    是的,這就是我要說的。隨著時間的推移,這會成為 ultraRapid 的主流嗎?凱文,您能否僅就成長利潤率進行指導?第一季你們的預期是 66% 到 68%,而你們的預期是 69%。也許只是談論那裡的一些讓步和收穫,特別是考慮到您在這裡推出了價格更高的 ultra 產品。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yeah. Look, it was a race. So we wanted to raise guidance because ultimately, we feel really comfortable with both the reimbursement profile as well as the trajectory on COGS. I think we remain absolutely optimistic that we can further drive down COGS per test.

    是的。看,這是一場比賽。因此,我們希望提高指導,因為最終,我們對報銷情況以及 COGS 的軌跡感到非常滿意。我認為我們仍然非常樂觀地認為我們可以進一步降低每次測試的 COGS。

  • But as we talked about in the past, feel fairly well-optimized from a wet lab perspective. The dry side lab is where we see opportunity for cost reductions that takes the deployment of some technology.

    但正如我們過去所討論的,從濕實驗室的角度來看,感覺已經相當優化了。我們看到,在乾側實驗室中,部署一些技術可以降低成本。

  • And so, in all things that we provide from a guidance perspective, we tend to take a prudent, conservative view and don't want to over-promise until we actually see some of those technologies deployed into production. And so you could rate it as fairly conservative while at the same time, we bumped up the range of gross margin up, we think, in a meaningful way.

    因此,從指導角度來看,我們提供的所有東西都傾向於採取謹慎、保守的觀點,並且在我們真正看到其中一些技術投入生產之前,我們不想過度承諾。因此,您可以將其評為相當保守,但同時,我們認為我們以有意義的方式提高了毛利率範圍。

  • I want to see some experience accumulated on those new indications to see if we're getting as well reimbursed. And we won't know that until we go through a natural cycle of producing the test, submitting to insurance, and then seeing the claims come back.

    我希望看到在這些新適應症上累積的一些經驗,看看我們是否能得到很好的補償。而只有當我們經歷了進行測試、提交保險、然後看到索賠回來的自然循環後,我們才會知道這一點。

  • And it's too early to tell, even on that first launch of CP. Just not mature enough to have the data to know whether or not reimbursement will be as high. So, left some room to be able to continually come back and beat and raise on that component throughout the year.

    即使 CP 首次推出,現在下結論還為時過早。只是還不夠成熟,沒有數據來判斷報銷金額是否會這麼高。因此,留出了一些空間,以便能夠在全年不斷回來、擊敗並提高這一部分。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • And then any guess on where you might end the year on denial rates? I guess you've got the Epic integration. Can that help? And then the biomarker bills you flagged as well, I mean, how important are those in improving the denial rates?

    那麼,您能猜測一下今年的拒絕率會達到多少嗎?我猜你已經獲得了 Epic 整合。這樣有幫助嗎?然後您還提到了生物標誌物帳單,我的意思是,這些對於提高拒絕率有多重要?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yeah. Driving down denials and improving that reimbursement rate is multifactorial. The progress on state Medicaid programs, absolutely helpful. We're serving all 50 states, whether they have coverage or not, running through COGS and taking zeros for the states without coverage.

    是的。降低拒付率和提高報銷率是多方面的。州醫療補助計劃的進展絕對有幫助。我們為全美 50 個州提供服務,無論這些州是否擁有覆蓋,我們都會計算 COGS,而沒有覆蓋的州則取零。

  • And so any state that picks up policy coverage, we think is great for patients. It's great for our business. And we think we're saving the Medicaid program dollars through the utilization of these tests.

    因此,我們認為,任何州如果能夠提供保險覆蓋,對患者來說都是好事。這對我們的業務很有好處。我們認為透過這些測試我們可以節省醫療補助計劃的資金。

  • So picked up another state this quarter in New Mexico. Obviously, it's not the biggest population center in the country, but they're all important. And I think also would note that the first quarter is not fully baked with respect to states in the past that have picked up coverage.

    因此本季在新墨西哥州又選擇了另一個州。顯然,它不是該國最大的人口中心,但它們都很重要。我還認為,值得注意的是,相對於過去已開始涵蓋的州而言,第一季的情況還不夠成熟。

  • So I go back to my comments that every month, we're taking a six month look back and dropping off an older month and picking up a newer month. And so even those states that enacted coverage in the fourth quarter or to start on January 1 have yet in our calculations to reach full maturity.

    因此,我回到我的評論,每個月,我們都會回顧六個月,去掉一個較舊的月份,然後選擇一個較新的月份。因此,即使那些在第四季度或 1 月 1 日開始實施保險的州,根據我們的計算,也尚未完全成熟。

  • And so we're still contemplating in those estimates periods where we might've been taking zeros and are no longer. It's what gives me the confidence to say that rate we just posted, well, yes, it has some quote true up adjustments. Those adjustments are more so ordinary course and should stay with us rather than something discrete or one off.

    因此,我們仍在考慮在那些估計期間我們可能一直取零,而現在不再取零。這讓我有信心說,我們剛剛發布的利率,是的,它有一些報價真實調整。這些調整更像是常規做法,應該持續下去,而不是離散的或一次性的調整。

  • Ultimately, we've been able to improve the denial rate a few hundred basis points each quarter in that underlying rate. And I'd expect that to continue for a few quarters or for the remaining quarters of the year. We're nowhere near optimized with the denial rate now probably in the mid-40s across all volume. And we absolutely think we should be getting paid something closer to 80% of the time over time.

    最終,我們能夠在每季將拒絕率提高數百個基點。我預計這種情況將持續幾個季度或今年剩餘的幾個季度。我們還遠遠沒有達到優化,現在所有交易量的拒絕率大概都在 40% 左右。我們絕對認為,隨著時間的推移,我們應該獲得接近 80% 的報酬。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • Okay, and then just last one for Katherine on pharma. You flagged making progress there. What should we be watching for over the remainder of this year?

    好的,最後再問凱瑟琳一個關於製藥的問題。您標記了那裡的進展。今年剩餘時間我們該關注什麼?

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Yeah. I think it's a steady drumbeat of additional partnerships and the nature of those partnerships where we're essentially doing patient matching.

    是的。我認為這是不斷增加的合作關係的鼓點,而這些合作夥伴關係的性質是我們主要進行患者匹配。

  • So eligibility for clinical trials, we have a new tool called GDX Discover that we introduced late last year. That's actually helping pharma companies really take a look at the true prevalence of some of these diseases. And it's been really rewarding to hear back from them that they are indeed saying that the prevalence for diseases are higher than what they anticipated.

    因此,對於臨床試驗的資格,我們有一個名為 GDX Discover 的新工具,是我們在去年年底推出的。這實際上有助於製藥公司真正了解某些疾病的真實流行程度。當我收到他們的回覆時,我感到非常欣慰,他們確實說疾病的盛行率高於他們的預期。

  • So that's fundamentally changing the way that they're thinking about their businesses. So continued partnerships throughout the course of this year. We're not going to change the outlook on contributions to revenue. I think we continue to see it as, as Kevin said on the call, early innings; but it's great to continue to see the contracts coming through DocuSign on the regular. So we're happy with that momentum.

    這從根本上改變了他們思考業務的方式。因此,今年全年將繼續保持合作關係。我們不會改變對收入貢獻的展望。我認為我們繼續將其視為,正如凱文在電話中所說的那樣,早期的局面;但很高興看到合約繼續定期透過 DocuSign 簽發。所以我們對這種勢頭感到滿意。

  • Operator

    Operator

  • Matt Sykes, Goldman Sachs.

    高盛的馬特·賽克斯 (Matt Sykes)。

  • Unidentified Participant

    Unidentified Participant

  • This is Will on for Matt. Just wanted to build on the Sunshine Genetics Act commentary earlier. While it's early days, it seems like support is growing for the whole genome approach. So have you seen any signs of a shift towards whole genome versus exome testing? And what are the differences in COGS between those two tests?

    這是威爾取代馬特。只是想在之前對《陽光遺傳法案》的評論的基礎上進行進一步的闡述。雖然還處於早期階段,但全基因組方法的支持似乎正在增長。那麼,您是否看到了從外顯子組測試轉向全基因組測試的跡象?這兩次測試的 COGS 有何不同?

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Yeah. So you're reading that correctly. When we first started talking to folks in Florida, it really was about inpatient and outpatient. And the gentleman who's sponsoring this bill had lost his son to a rare disease.

    是的。所以你讀得對。當我們第一次與佛羅裡達州的人交談時,我們討論的實際上是住院和門診的問題。而支持這項法案的先生的兒子則因一種罕見疾病去世了。

  • So when we started talking about the GUARDIAN study, it really captivated his vision for being able to accelerate this. As I said in my commentary, we're waiting for these kids to get sick. Newborn screening helped in the GUARDIAN study identify a positive diagnosis in 3.2% of these babies who otherwise would not have been diagnosed until they were likely at least five years old.

    因此,當我們開始談論《衛報》的研究時,它真正吸引了他能夠加速這一進程的願景。正如我在評論中所說,我們正在等待這些孩子生病。在《衛報》的研究中,新生兒篩檢幫助 3.2% 的嬰兒確診了該疾病,否則這些嬰兒可能至少要到五歲時才能得到診斷。

  • So we're excited about the momentum that is building there. And we do think that -- as we have been testifying in the state of Florida related to that legislation, we think that there's an important opportunity.

    因此,我們對那裡正在形成的勢頭感到興奮。我們確實認為——正如我們在佛羅裡達州就該立法作證時所說,我們認為這是一個重要的機會。

  • I know they're putting themselves forth as being the standard and other states should be paying attention to that. And the federal government should be paying attention to it as well. So we hope that other states will follow.

    我知道他們正在建立自己的標準,其他州應該關注這一點。聯邦政府也應該關注這一點。因此我們希望其他州也能效法。

  • And we think in our state-by-state conversations that we have with Medicaid and policymakers, we'll continue to talk about Guardian and we'll continue to point to Florida as being the model for what excellence looks like in terms of putting genomics at the forefront and getting ahead of these kids getting really sick.

    我們認為,在我們與醫療補助計劃和政策制定者進行的逐州對話中,我們將繼續討論 Guardian,並將繼續指出佛羅裡達州是將基因組學放在首位並在這些孩子真正生病之前取得成功的典範。

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • Yeah, the overall cost to produce genome is slightly higher today. Most of that actually is just pass-through costs on reagents. So could use some help from our partners there in bringing down consumable costs if you look at exome versus genome.

    是的,如今生產基因組的整體成本略高一些。其中大部分其實只是試劑的轉嫁成本。因此,如果您比較外顯子組和基因組,我們可以從我們的合作夥伴那裡獲得一些幫助,以降低消耗品成本。

  • But the gross margin profile between the two product lines, fairly similar. We're, at this point, relatively agnostic on whether it's an exome or a genome coming in. Both are good for our business. Both are good answers for physicians and their patients.

    但兩條產品線的毛利率狀況相當相似。目前,我們對於進入的是外顯子組還是基因組還比較不確定。兩者對我們的業務都有好處。對於醫生和患者來說,這兩者都是很好的答案。

  • The majority of that exome genome line for us today is exome, but that's frankly just where payers have been in terms of overall reimbursement. Do we expect that to change towards parity and ultimately the majority being whole genome? We do.

    對我們來說,今天外顯子組基因組的大部分都是外顯子組,但坦白說,這只是付款人在整體報銷方面所處的位置。我們是否期望這種情況會朝著均等的方向轉變,並最終實現全基因組的大多數?是的。

  • Our ticker symbol should be reflective of that. We certainly see a world where all hereditary disease is diagnosed off of a whole genome, and we're well-prepared to lead that market.

    我們的股票代碼應該反映這一點。我們確實看到了一個所有遺傳疾病都可以透過整個基因組進行診斷的世界,我們已經做好了充分的準備來引領這個市場。

  • We lead the exome market today with 80% or higher market share of clinical exomes and genomes, with the majority being exome, and are well-positioned to lead the market as it makes its transition to whole genome, which we fully expect. And our data assets and capabilities and interpretation platform all very much geared to service that market.

    目前,我們在外顯子組市場處於領先地位,在臨床外顯子組和基因組市場中佔有 80% 或更高的份額,其中大部分是外顯子組,並且我們完全有條件在市場向全基因組過渡時引領市場,我們完全有信心實現這一目標。我們的數據資產、能力和解釋平台都非常適合服務該市場。

  • Unidentified Participant

    Unidentified Participant

  • That's super helpful. And then just acknowledging there's a lot of uncertainty around policy changes now. But given your exposure to Medicaid, just wanted to get your thoughts on any risks around potential Medicaid cuts to your business.

    這非常有幫助。然後承認現在政策變化存在著許多不確定性。但考慮到您對醫療補助計劃的了解,我只是想了解您對醫療補助計劃削減可能對您的業務帶來的風險的看法。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Yeah. There obviously continues to be an acute focus on reconciliation in DC. I've been spending a lot of time there. I will say the health of children in the United States continues to be something that everyone can agree on despite all the noise that's out there.

    是的。顯然,華盛頓仍然高度關注和解問題。我已經在那裡度過了很多時間。我想說的是,儘管外界有許多爭議,但美國兒童的健康狀況仍是大家一致認可的。

  • So as we continue to work through, I think, the coming weeks and likely months on the government getting to reconciliation, we continue to believe that this remains exactly how Medicaid was designed for ensuring that the most vulnerable Americans, young children who are sick, will have access to good healthcare.

    因此,我認為,在未來幾週甚至幾個月的時間裡,隨著政府繼續努力達成和解,我們仍然相信,醫療補助計劃的設計初衷就是確保最脆弱的美國人,即生病的幼兒,能夠獲得良好的醫療保健。

  • Operator

    Operator

  • Brandon Couillard, Wells Fargo.

    布蘭登‧庫亞爾 (Brandon Couillard),富國銀行。

  • Brandon Couillard - Analyst

    Brandon Couillard - Analyst

  • Kevin, in terms of the weather impact in the quarter, wouldn't you expect to actually recoup those tests in 2Q? Or are you just assuming that those are foregone at this point? And then for the hereditary cancer line, will there still be some residual contribution into the second half as you wind that down?

    凱文,就本季的天氣影響而言,您難道不認為能夠在第二季收回這些測試的損失嗎?或者您只是假設這些現在都已經放棄了?那麼對於遺傳性癌症系列,當您逐漸減少它時,下半年是否還會有一些殘留貢獻?

  • Kevin Feeley - Chief Financial Officer

    Kevin Feeley - Chief Financial Officer

  • On the latter, I'd expect hereditary cancer to be zero or near zero in the second half of the year. So only some residual effects here for the remainder of the second quarter.

    就後者而言,我預計今年下半年遺傳性癌症的發生率將為零或接近零。因此,第二季剩餘時間僅會產生一些殘留影響。

  • Yeah, it's a great point in terms of the weather impacts on appointments. Different than a routine clinical lab where people might miss things like annual physicals and then not get back to it, these kids are symptomatic and sick. And so any missed appointment, you would expect to see that recovered.

    是的,從天氣對預約的影響來看,這是一個很好的觀點。與常規臨床實驗室不同,人們可能會錯過諸如年度體檢之類的事情,然後再也不回來,這些孩子有症狀並且生病了。因此,對於任何錯過的預約,您都希望能夠得到彌補。

  • The issue here though is with the scarcity of expert geneticists and pediatric specialists who order these tests today, i.e. a pediatric neurologist or geneticist. They're just long wait times to get back into the office. And so if you happen to miss an appointment, it may be weeks or even months before you can get back into the office.

    但這裡的問題是,目前要求進行這些測試的專業遺傳學家和兒科專家(即兒科神經科醫生或遺傳學家)很少。他們只是需要等待很長時間才能回到辦公室。因此,如果您錯過預約,可能要過幾週甚至幾個月才能回到辦公室。

  • Frankly, that scarcity of docs who can order these tests is something we're working hard to solve for. A major move we think ultimately would be to open up the pediatrician as an order for exome and genome. To do that, we've got to drive down complexity.

    坦白說,我們正在努力解決能夠安排這些測試的醫生短缺的問題。我們認為最終的一項重大舉措是向兒科醫生開放外顯子組和基因組的命令。為了做到這一點,我們必須降低複雜性。

  • We've got to make the user experience seamless, drive down costs and speed. And that's what GeneDx has been working a decade to do. So yeah, would expect all those appointments to come back. But in this particular setting, sometimes, it takes weeks or even months to get back into a specialist office.

    我們必須讓使用者體驗無縫銜接,降低成本並提高速度。這正是 GeneDx 十年來一直努力的目標。是的,我希望所有這些任命都能恢復。但在這種特殊情況下,有時需要數週甚至數月才能回到專科辦公室。

  • Operator

    Operator

  • I'm showing no further questions at this time. I'd like to turn it back to Katherine Stueland for closing remarks.

    我目前沒有其他問題。我想請凱瑟琳·斯圖蘭德 (Katherine Stueland) 做最後發言。

  • Katherine Stueland - Chief Executive Officer, Director

    Katherine Stueland - Chief Executive Officer, Director

  • Excellent. Well, thank you so much for joining us today. We look forward to seeing you in the coming weeks and the coming months at conferences. And we'll talk to you soon.

    出色的。好吧,非常感謝您今天加入我們。我們期待在未來幾週和幾個月的會議上見到您。我們很快就會和你聯絡。

  • Operator

    Operator

  • This concludes today's conference call. Thank you for participating, and you may now disconnect.

    今天的電話會議到此結束。感謝您的參與,您現在可以斷開連接了。