BillionToOne, Inc. (BLLN) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • In three, two, one. Thank you for standing by and welcome to the BillionToOne first quarter 2026 earnings call. (Operator Instructions)

    三、二、一。感謝各位稍候,歡迎參加 BillionToOne 2026 年第一季財報電話會議。(接線員指示)

  • As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, [David Deichler], Investor Relations. Please go ahead, sir.

    提醒各位,今天的節目將被錄音。現在我想介紹今天節目的主持人,[David Deichler],投資人關係。先生,請開始。

  • David Deichler - Investor Relations

    David Deichler - Investor Relations

  • Good afternoon, everyone. Thank you for participating in today's conference call. Joining me on the call from BillionToOne, we have Oguzhan Atay, Co-Founder and Chief Executive Officer, and Ross Taylor, Chief Financial Officer. Earlier today, BillionToOne released financial results for the first quarter ended March 31, 2026.

    各位下午好。感謝各位參與今天的電話會議。與我一同出席本次電話會議的 BillionToOne 團隊成員包括共同創辦人兼執行長 Oguzhan Atay,以及財務長 Ross Taylor。今天稍早,BillionToOne 公布了截至 2026 年 3 月 31 日止第一季的財務結果。

  • A copy of the press release is available on the company's website. Before we begin, I want to remind you that during this call, we may make forward-looking statements within the meaning of federal securities laws.

    新聞稿副本可於公司網站取得。在開始之前,我想提醒各位,在本次電話會議中,我們可能會在聯邦證券法的意義下作出前瞻性陳述。

  • Such statements about future events may include statements about our financial outlook and performance, market size, our products and services, reimbursement coverage, future clinical performance, and other similar statements.

    此類關於未來事件的陳述可能包括我們的財務展望與表現、市場規模、我們的產品與服務、給付/報銷覆蓋範圍、未來臨床表現,以及其他類似陳述。

  • We caution you that such statements reflect our current best judgment and actual results may differ materially from those expressed or implied in any forward-looking statements.

    我們提醒各位注意,此類陳述反映我們目前最佳判斷,實際結果可能與任何前瞻性陳述中明示或暗示的內容存在重大差異。

  • Risk factors that may cause our results to differ are discussed in our filings with the SEC, including our previously filed annual report, Form 10-K, our quarterly report on Form 10-Q to be filed following this call, and the current report on Form 8-K filed today.

    可能導致我們結果出現差異的風險因素,已在我們向美國證券交易委員會(SEC)提交的文件中討論,包括先前提交的年度報告 Form 10-K、將於本次電話會議後提交的季度報告 Form 10-Q,以及今日提交的當前報告 Form 8-K。

  • Any forward-looking statement made during this call is made as of today, May 6, 2026. If this call is replayed or reviewed after today, the information made during this call may not contain current or accurate information. 2021 disclaims any obligation to publicly update any forward-looking statements, whether because of new information, future events, or otherwise, except as required by law.

    本次電話會議中所作的任何前瞻性陳述,均以今天(2026 年 5 月 6 日)為準。若本次電話會議在今日之後被重播或回顧,會議中所提供的資訊可能不再是最新或準確資訊。2021 不承擔公開更新任何前瞻性陳述之義務(無論因新資訊、未來事件或其他原因),法律另有規定者除外。

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

    接下來,我把電話交給 Oguzhan。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Good afternoon, everyone. Thank you for joining our first quarter 2026 earnings call.

    各位下午好。感謝各位參加我們 2026 年第一季財報電話會議。

  • I'd like to start by thanking our employees who work with tremendous effort and diligence to build and deliver superior tests to our patients that improve their care and remove the fear of the unknown.

    我想先感謝我們的員工,他們以極大的努力與勤勉,為病患打造並提供更優質的檢測,改善照護並消除對未知的恐懼。

  • Before diving into our quarterly results, I would like to remind you of our four pillars that I believe make us a different category of molecular diagnostics company.

    在深入說明本季業績之前,我想提醒各位我們的四大支柱;我相信這些支柱使我們成為一個不同類別的分子診斷公司。

  • First, our revolutionary technology platform, which is enabled by our patented QCT (Quantitative Counting Template) technology, achieves single-molecule-level sensitivity and precision with next-generation sequencing.

    第一,我們革命性的技術平台,藉由我們已獲專利的 QCT(Quantitative Counting Template,定量計數模板)技術,使次世代定序達到單分子等級的靈敏度與精準度。

  • With this technology, we have built unique category-defining products in both prenatal and oncology. With our differentiated products, we have grown exponentially in the last six years, even as we reach scale, with a level of compounding that we believe is rare in our industry.

    憑藉這項技術,我們在產前與腫瘤兩大領域打造了獨特、定義類別的產品。憑藉差異化產品,我們在過去六年呈指數型成長;即使規模擴大,我們仍維持我們認為在本產業相當罕見的複利式成長水準。

  • But there is still so much room to grow, as the opportunity of prenatal and oncology cfDNA markets can exceed $100 billion in US market opportunity over time.

    但我們仍有很大的成長空間,因為產前與腫瘤 cfDNA 市場的機會,長期而言在美國的市場機會可超過 1,000 億美元。

  • In addition to rapid growth, we have achieved a superior gross margin profile, with margins now about 70%, with still significant room for expansion through ASV growth and cost-per-test reductions. Lastly, through a culture of fiscal discipline and efficient operations incorporating AI and automation.

    除了快速成長之外,我們也達成優異的毛利率結構,目前毛利率約 70%,並仍可透過 ASV 成長與每次檢測成本下降,帶來顯著的擴張空間。最後,透過財務紀律與高效率營運的文化,並導入 AI 與自動化。

  • We achieved GAAP profitability and positive cash flow with less than 10% of the accumulated deficit of our public competitors. In summary, we continue to track towards our long-term goal, which has remained the same, to build a category-defining generational company and become a member of the S&P 500.

    我們以不到公開市場同業累積虧損(accumulated deficit)的 10%,就達成 GAAP 獲利與正向現金流。總結而言,我們持續朝向長期目標邁進,而該目標始終如一:打造一家定義類別、世代級的公司,並成為標普 500 指數成分股。

  • Our first quarter performance was extremely strong across all four pillars. For the third quarter in a row, we delivered a rule of 100 plus, and this time, in this quarter, we paired it with a level of profitability that is extremely rare for a high-growth company. We had another quarter of high growth, expanded margins, positive operating income, and positive cash flow.

    我們第一季在四大支柱上表現都非常強勁。連續第三個季度,我們達成「rule of 100 plus」,而這一季更搭配了對高成長公司而言極為罕見的獲利水準。我們再度交出高成長、毛利率擴張、正向營業利益與正向現金流的一季。

  • Looking at our results, pillar by pillar, in addition to expanded fetal antigen NIPT and FNAT NIPT launches for prenatal, and PGx and CH launches for oncology that were launched in February, after the end of the quarter, we launched a category-redefining prenatal test. UnityConfirm.

    逐一檢視各支柱的成果:除了產前領域擴增的胎兒抗原 NIPT 與 FNAT NIPT 上市,以及腫瘤領域於 2 月推出的 PGx 與 CH(在季度結束後)之外,我們還推出了一項重新定義類別的產前檢測。UnityConfirm。

  • UnityConfirm is the first non-invasive fetal cell-based confirmation assay for high-risk NIPTs. On the oncology side, our product roadmap remains on track. We responded to all MLD-X comments for our response coverage submission, and our tumor naive MRD launch is on track to launch by the end of this year.

    UnityConfirm 是首個針對高風險 NIPT 的非侵入性胎兒細胞型確認檢測(confirmation assay)。在腫瘤領域,我們的產品路線圖仍按計畫推進。我們已回應回覆覆蓋(response coverage)送件中所有 MLD-X 意見,而我們的腫瘤未治療(tumor naive)MRD 上市計畫仍按進度,預計於今年底前推出。

  • As we continue to launch new products, our business continues to grow, delivering consistent test volume growth of 44% year-over-year and total revenue growth of 84% year-over-year. In our third pillar, we have continued our progress with our in-network contracts, most importantly, with a contract with Anthem.

    隨著我們持續推出新產品,我們的業務持續成長,檢測量年增 44%,總營收年增 84%。在第三支柱方面,我們持續推進加入保險網內(in-network)合約的進展,最重要的是與 Anthem 的合約。

  • Bringing our total contracted lives to 300 million in the United States. As our ASVs increased 28% year-over-year to $571 per test, and as we maintained our COGS at $153 per test, despite a higher proportion of oncology tests that have a higher COGS.

    使我們在美國的合約覆蓋人數(contracted lives)總計達到 3 億。隨著我們的 ASV 年增 28% 至每次檢測 571 美元,且儘管腫瘤檢測占比提高(其 COGS 較高),我們仍將 COGS 維持在每次檢測 153 美元。

  • We expanded our gross margins to 73% in Q1, a strong 9 percentage point increase year-over-year. And finally, in our fourth pillar, as our gross margins expanded and as we operated with higher efficiency.

    我們在第一季將毛利率擴張至 73%,較去年同期強勁提升 9 個百分點。最後,在第四支柱方面,隨著毛利率擴張以及我們以更高效率營運。

  • We delivered a remarkable profitability profile in the first quarter with a 16% GAAP operating margin and 24% adjusted EBITDA margin, increasing our cash position to $537.5 million at the end of the quarter.

    我們在第一季交出亮眼的獲利結構:GAAP 營業利益率 16%,調整後 EBITDA 利益率 24%,並使季度末現金部位提升至 5.375 億美元。

  • Delving into each pillar one by one, for our first pillar, on May 1, just five days ago, at ACOG annual meeting, we moved the field forward once again by launching what we believe is going to be seen as the innovation of the decade in prenatal genetics. UnityConfirm is the first and only non-invasive confirmation assay for high-risk pregnancies.

    逐一深入說明各支柱:在第一支柱方面,5 月 1 日,也就是五天前,在 ACOG 年會上,我們再次推動領域向前,推出我們相信將被視為產前遺傳學十年一遇的創新。UnityConfirm 是第一個也是唯一一個針對高風險妊娠的非侵入性確認檢測。

  • It represents what many in our field have long considered the holy grail of non-invasive prenatal testing. UnityConfirm captures and sequences intact circulating fetal cells from a maternal blood sample, providing 100% fetal fraction.

    它代表了我們領域中許多人長期以來所認為的非侵入性產前檢測「聖杯」。UnityConfirm 可從孕婦血液樣本中捕捉並定序完整的循環胎兒細胞,提供 100% 的胎兒比例(fetal fraction)。

  • To put that in perspective, conventional cell-free DNA tests rely on small fractions of fetal DNA in maternal plasma. By isolating and sequencing whole fetal cells directly, UnityConfirm is in a fundamentally different category.

    為了讓各位更有概念,傳統的游離 DNA 檢測仰賴母體血漿中少量比例的胎兒 DNA。透過直接分離並定序完整胎兒細胞,UnityConfirm 在本質上屬於完全不同的類別。

  • We have launched UnityConfirm as a specialized offering, as a follow-up for high-risk pregnancies identified on our Unity aneuploidy screen.

    我們將 UnityConfirm 以專門方案推出,作為在我們 Unity 非整倍體篩檢(aneuploidy screen)中被判定為高風險妊娠的後續追蹤。

  • Today, if an NIPT returns a high-risk result, the next step is invasive diagnostic testing, which is increasingly inaccessible in maternity care deserts and also carries a small miscarriage risk. The majority of patients. Cannot or choose not to proceed to invasive diagnostic confirmation.

    目前,若 NIPT 回傳高風險結果,下一步是侵入性診斷檢測;然而在孕產照護沙漠地帶(maternity care deserts)中此類檢測愈發難以取得,且也帶有小幅流產風險。大多數病患。無法或選擇不進行侵入性診斷確認。

  • UnityConfirm addresses this critical clinical gap. It gives these patients and their physicians a non-invasive option. Our initial results have shown 100% concordance compared to invasive diagnostics.

    UnityConfirm 彌補了這項關鍵的臨床缺口。它為這些患者及其醫師提供了一種非侵入性的選擇。我們的初步結果顯示,與侵入性診斷相比達到 100% 的一致性。

  • And we are now enrolling patients in what we believe is the largest prospective circulating fetal cell-based study ever conducted with concordance to invasive diagnostics. We also built a comprehensive launch campaign around UnityConfirm. More than 500 providers attended the launch or watched on the live stream.

    而我們目前正在招募患者,進行我們認為是迄今規模最大的、以循環胎兒細胞為基礎且與侵入性診斷進行一致性比對的前瞻性研究。我們也圍繞 UnityConfirm 建立了一套全面的上市推廣活動。超過 500 位醫療服務提供者參加了上市活動或透過直播觀看。

  • We believe UnityConfirm will further increase the differentiation of our Unity product offerings. Turning to our second pillar, Scalable Rapid Growth. Our leadership in product innovation and our growing commercial team continue to drive strong test volume in the quarter.

    我們相信 UnityConfirm 將進一步提升我們 Unity 產品組合的差異化。接著談到我們的第二個支柱:可擴展的快速成長。我們在產品創新方面的領導地位,以及持續擴大的商業團隊,推動本季檢測量維持強勁。

  • In Q1, we delivered approximately 188,000 tests, representing 44% year-over-year growth and strong sequential growth across both product lines, with prenatal volumes growing approximately 10% quarter-over-quarter and oncology volumes growing approximately 25% quarter-over-quarter.

    在第一季,我們交付約 188,000 次檢測,年增 44%,且兩條產品線皆呈現強勁的季增;其中產前檢測量約季增 10%,腫瘤檢測量約季增 25%。

  • Importantly, on the oncology side, approximately 60% of NorthStar Select orders now obtain to CH, reflecting growing physician awareness of the importance of distinguishing tumor-derived from non-tumor-derived variants in liquid biopsy. Our total revenues in the first quarter grew even faster, achieving 84% year-over-year growth.

    重要的是,在腫瘤業務方面,目前約 60% 的 NorthStar Select 訂單會取得 CH,反映醫師對於在液體活檢中區分腫瘤來源與非腫瘤來源變異之重要性的認知正在提升。我們第一季的總營收成長更快,達成 84% 的年增率。

  • This was driven by 44% year-over-year growth in test volume and 28% year-over-year growth in ASB. Looking at the segment detail, both prenatal and oncology contributed meaningfully to our growth. Prenatal revenue in the first quarter was $97.7 million, up 72% year-over-year.

    這主要由檢測量年增 44% 以及 ASB 年增 28% 所帶動。從分部細項來看,產前與腫瘤兩者都對我們的成長做出了重要貢獻。第一季產前營收為 9,770 萬美元,年增 72%。

  • Driven by strong volume growth, commercial execution, and additional traction driven by our fetal antigen test products launched at SMFM in February.

    這得益於強勁的量能成長、商業執行力,以及我們於 2 月在 SMFM 推出的胎兒抗原檢測產品所帶來的額外動能。

  • This continues to underscore the depth of Unity's differentiation and the durability of our prenatal growth. Oncology revenue was nearly five times over last year, reaching.

    這持續凸顯 Unity 差異化的深度,以及我們產前業務成長的持久性。腫瘤營收接近去年的五倍,達到。

  • $10.7 million in the first quarter, and annualized revenue run rate of $43 million. The oncology ramp is being driven by increasing adoption of both NorthStar Select and NorthStar Response, the recent launches of PGX and CH, and strong execution of our oncology commercial team.

    第一季為 1,070 萬美元,年化營收運行率為 4,300 萬美元。腫瘤業務的爬坡主要由 NorthStar Select 與 NorthStar Response 的採用率提升、近期 PGX 與 CH 的上市,以及我們腫瘤商業團隊的強勁執行所驅動。

  • We continue to see substantial opportunity ahead in oncology. As we continue to grow our sales team, build clinical evidence, and pursue Medicare coverage for NorthStar Response.

    我們在腫瘤領域仍看到前方有相當大的機會。我們將持續擴大銷售團隊、建立臨床證據,並為 NorthStar Response 爭取 Medicare 給付。

  • Before discussing ASBs and COGS, I want to highlight a major step forward this quarter. I'm pleased to announce that Billions One is now in-network with Anthem, one of the largest health insurers in the United States.

    在討論 ASBs 與 COGS 之前,我想先強調本季的一項重大進展。我很高興宣布,Billions One 現已成為 Anthem 的網內服務提供者;Anthem 是美國最大的健康保險公司之一。

  • This brings our total contracted lives to approximately 300 million in the US, representing more than 90% of patients. Following the in-network agreement we announced last quarter with UnitedHealthcare, the addition of Anthem further strengthens our market access position.

    這使我們在美國的合約涵蓋人數總計約 3 億,代表超過 90% 的患者。繼我們上季宣布與 UnitedHealthcare 達成網內協議後,新增 Anthem 進一步強化了我們的市場准入地位。

  • As I have noted previously, an in-network contract removes friction for both physicians and patients. Increases access, and over time results in higher and more predictable ASPs.

    如我先前所提到,網內合約可降低醫師與患者雙方的摩擦。提升可近性,並隨時間推進帶來更高且更可預測的 ASP。

  • Turning to ASPs, we continue to see growth in the first quarter, with overall ASP increasing to $571 per test, a 28% year-over-year increase, and a $10 per test sequential increase.

    談到 ASP,我們第一季持續成長,整體 ASP 提升至每次檢測 571 美元,年增 28%,且較前一季每次檢測增加 10 美元。

  • This increase was despite the largely temporary effect of resetting of coinsurance and deductibles at the beginning of the year.

    即便年初共同保險與自付額重置帶來的影響在很大程度上屬於暫時性,本次仍實現了成長。

  • We continue to expect substantial room for ASB expansion ahead, driven by additional Medicaid adoptions of our carrier panel PLA code, the continued mix shift to higher ASB oncology tests, and in time, we expect Medicare coverage of our NorthStar Response test.

    我們仍預期未來 ASB 仍有相當大的擴張空間,動能來自更多 Medicaid 對我們 carrier panel PLA 代碼的採用、產品組合持續轉向 ASB 較高的腫瘤檢測,以及隨時間推進,我們預期 NorthStar Response 檢測將獲得 Medicare 給付。

  • In addition to driving ASV growth, we have remained committed to our operating philosophy of continuous improvement to reduce COGS per test. Our overall COGS per test was $153 in the first quarter, down 5% sequentially and only 1% higher year-over-year. This was a particularly significant achievement given two factors.

    除了推動 ASV 成長之外,我們也持續秉持「持續改善」的營運理念,以降低每次檢測的 COGS。第一季我們整體每次檢測的 COGS 為 153 美元,較前一季下降 5%,且年增僅 1%。考量兩項因素,這是一項特別重要的成果。

  • First, the continued mix shift toward a higher proportion of oncology tests, which have higher COGS per test. And second, the COGS impact from recent product launches and enhancements, such as CH.

    第一,產品組合持續轉向腫瘤檢測占比更高,而腫瘤檢測的每次 COGS 較高。第二,近期產品上市與功能增強(例如 CH)對 COGS 的影響。

  • While we expect to continue to see COGS per test reductions, especially in oncology, over the long-term, we expect overall COGS per test.

    雖然我們預期每次檢測的 COGS 將持續下降,尤其是在腫瘤領域,但從長期來看,我們預期整體每次檢測的 COGS。

  • Increased gradually over time as our oncology business continues to grow faster. As our overall ASPs continued to increase and our overall COGS per test remained approximately stable, our gross margin profile expanded further in the first quarter. Gross margins were 73% in Q1.

    將隨時間逐步上升,因為我們的腫瘤業務持續以更快速度成長。隨著整體 ASP 持續提升且整體每次檢測的 COGS 大致維持穩定,我們第一季的毛利率結構進一步擴張。第一季毛利率為 73%。

  • Representing a nine percentage point year-over-year increase from 64% in the first quarter of 2025 and a two percentage point sequential increase from 71% in Q4 2025. The increase was primarily driven by continued increase in prenatal ASV and significant cause deductions in oncology.

    相較 2025 年第一季的 64%,年增 9 個百分點;相較 2025 年第四季的 71%,季增 2 個百分點。本次提升主要由產前 ASV 持續增加,以及腫瘤端顯著的成本扣減所帶動。

  • We are encouraged by the margin trajectory in both segments. While the faster growth of our oncology business can influence margins, as oncology currently has lower margins due to lower volume scale and prior to Medicare coverage of response, we expect to maintain strong overall gross margins, above 70%.

    我們對兩個分部的毛利率走勢感到鼓舞。雖然腫瘤業務更快的成長可能影響毛利率(因腫瘤目前因規模較小、且在 Response 尚未取得 Medicare 給付前毛利率較低),但我們預期整體毛利率仍可維持強勁、在 70% 以上。

  • Finally, our first-quarter performance allowed us to continue making important strides toward our long-term goals.

    最後,我們第一季的表現使我們得以持續朝長期目標邁出重要步伐。

  • We delivered a 16% GAAP operating margin and a 24% adjusted EBITDA margin in Q1, while continuing to invest meaningfully in our sales force, in new product launches, and in clinical evidence generation.

    第一季我們達成 16% 的 GAAP 營業利益率,以及 24% 的調整後 EBITDA 利益率,同時仍持續對銷售團隊、新產品上市與臨床證據產出進行有意義的投資。

  • I'd like to note again that we have achieved this profitability. At a much smaller scale than our competitors, while growing faster and with less than 10% of their accumulated deficits.

    我想再次指出,我們已實現這樣的獲利能力。是在遠小於競爭對手的規模下達成,同時成長更快,且累積虧損不到他們的 10%。

  • This combination of growth and profitability speaks to the uniqueness of our technology, the differentiation of our product portfolio, and our operational discipline.

    這種成長與獲利並存的組合,凸顯了我們技術的獨特性、產品組合的差異化,以及我們的營運紀律。

  • With that, I will turn the call over to Ross to review our financial results and updated 2026 guidance before I conclude.

    接下來,我將把電話會議交給 Ross,在我做結語之前,由他回顧我們的財務結果以及更新後的 2026 年財測指引。

  • Ross Taylor - Chief Financial Officer

    Ross Taylor - Chief Financial Officer

  • Thank you, Oguzhan Atay. As Oguzhan Atay mentioned, in Q1 of 2026, we had a strong performance that combined 84% year-over-year revenue growth with 16% operating margin and 24% adjusted EBITDA margin.

    謝謝你,Oguzhan Atay。如 Oguzhan Atay 所提到,2026 年第一季我們表現強勁,營收年增 84%,同時達成 16% 的營業利益率與 24% 的調整後 EBITDA 利益率。

  • Total revenue in the first quarter of 2026. Was $108.4 million, compared to $59.0 million in the first quarter of 2025, representing an increase of 84%. Both our prenatal and oncology product lines demonstrated strong growth in the quarter.

    2026 年第一季總營收。為 1.084 億美元,相較 2025 年第一季的 5,900 萬美元,成長 84%。我們的產前與腫瘤兩條產品線在本季皆展現強勁成長。

  • Prenatal revenues, consisting of clinical testing revenues and revenues from clinical trial support and other services, increased 72% to $97.7 million in Q1.

    產前營收(包含臨床檢測營收,以及臨床試驗支援與其他服務營收)在第一季成長 72%,至 9,770 萬美元。

  • Oncology revenues increased almost 400% to $10.7 million in Q1 of 2026 versus Q1 of last year. Our total revenue growth was driven primarily by test volume growth across both prenatal and oncology, as well as continued expansion of both our prenatal and oncology ASPs.

    腫瘤營收在 2026 年第一季較去年第一季增加近 400%,至 1,070 萬美元。我們的總營收成長主要由產前與腫瘤兩端的檢測量成長所帶動,並且也受惠於產前與腫瘤 ASP 的持續擴張。

  • True-up revenue was $9.2 million in the first quarter of 2026, compared to $8.4 million in the fourth quarter of 2025 and $2.9 million in the first quarter of 2025.

    2026 年第一季的 True-up 收入為 920 萬美元,較 2025 年第四季的 840 萬美元及 2025 年第一季的 290 萬美元為高。

  • Excluding True-up revenue, total revenue growth in Q1 was 77% compared to the same period last year. Gross profit in the first quarter of 2026 was $79.1 million, compared to $38.0 million in the first quarter of 2025.

    若排除 True-up 收入,第一季總收入較去年同期成長 77%。2026 年第一季毛利為 7,910 萬美元,較 2025 年第一季的 3,800 萬美元為高。

  • Resulting in a gross margin of 73% in the first quarter of 2026 versus 64% in the first quarter of 2025. The increase in gross margins was primarily attributable to continued increases in our overall ASP.

    因此,2026 年第一季毛利率為 73%,相較之下 2025 年第一季為 64%。毛利率的提升主要歸因於我們整體 ASP(平均售價)的持續上升。

  • Total operating expenses were $61.2 million in the first quarter of 2026, compared to $40.3 million in the comparable prior-year quarter, representing an increase of 52%.

    2026 年第一季總營業費用為 6,120 萬美元,較去年同期可比季度的 4,030 萬美元增加 52%。

  • Within total operating expenses, R&D expense was $14.7 million in the first quarter of 2026, compared to $10.4 million in the comparable prior-year quarter, while SG&A expense was $46.6 million in the first quarter of 2026, compared to $29.9 million in the comparable prior-year quarter.

    在總營業費用中,2026 年第一季研發費用為 1,470 萬美元,較去年同期可比季度的 1,040 萬美元為高;而銷售、一般及行政(SG&A)費用為 4,660 萬美元,較去年同期可比季度的 2,990 萬美元為高。

  • We continue to invest in our commercial team, R&D, and clinical evidence generation, yet operating expenses as a percentage of revenue declined materially.

    我們持續投資於商業團隊、研發以及臨床證據的產出,但營業費用占收入的比例已明顯下降。

  • Operating income was $17.8 million in the first quarter of 2026, compared to an operating loss of $2.3 million in the first quarter of 2025.

    2026 年第一季營業利益為 1,780 萬美元,相較之下 2025 年第一季為 230 萬美元的營業損失。

  • Our Q1 operating profit margin was 16%. Representing a meaningful step-up from the 11% operating margin we delivered in the fourth quarter of 2025. Adjusted EBITDA in the quarter represented a 24% margin.

    我們第一季的營業利益率為 16%。相較於 2025 年第四季我們達成的 11% 營業利益率,這代表顯著提升。本季調整後 EBITDA 利潤率為 24%。

  • Net income available to common shareholders was $18.0 million or $0.34 per diluted share in the first quarter of 2026, compared to a net loss of $4.0 million or $0.39 per diluted share for the same period of 2025.

    2026 年第一季歸屬普通股股東的淨利為 1,800 萬美元,或稀釋後每股 0.34 美元;相較之下,2025 年同期為淨損 400 萬美元,或稀釋後每股虧損 0.39 美元。

  • Cash flow from operations minus capital expenditures was $11 million in the first quarter of 2026. We are well capitalized with a very healthy balance sheet. We ended the first quarter with $537 million in cash and equivalents.

    2026 年第一季營運現金流量扣除資本支出後為 1,100 萬美元。我們資本充足,資產負債表非常健全。第一季末我們持有 5.37 億美元的現金及約當現金。

  • We believe our balance sheet positions us for strong growth moving forward, particularly given our intent to continue to manage the business for profitability and positive cash flow.

    我們相信,我們的資產負債表使我們在未來具備強勁成長的條件,特別是考量到我們將持續以獲利與正向現金流來管理業務的意圖。

  • Finally, I will provide an update on our full-year guidance for 2026. We are raising our 2026 total revenue outlook to a range of $450 million to $465 million, representing growth of 48% to 52% compared to full-year 2025.

    最後,我將更新我們 2026 年全年的財測指引。我們將 2026 年總收入展望上調至 4.50 億至 4.65 億美元區間,較 2025 年全年成長 48% 至 52%。

  • Our new revenue guidance is a $20 million increase at both ends of the range over our previous guidance of $430 million to $445 million that we provided in early March.

    我們新的收入指引區間上下限各較先前指引上調 2,000 萬美元;先前我們在 3 月初提供的指引為 4.30 億至 4.45 億美元。

  • We are raising our guidance to reflect the strength of our business in Q1, as well as our expectation that new payer contracts will benefit our ASPs over the remainder of the year.

    我們上調指引以反映第一季業務的強勁表現,以及我們預期新增的付款方(payer)合約將在今年剩餘期間帶動 ASP 的提升。

  • Also, we expect to operate the business such that we will continue to generate profitability approaching current levels, even with significant continued investments.

    此外,我們預期將以一種方式來營運業務,使我們即使在持續進行重大投資的情況下,仍能持續產生接近目前水準的獲利能力。

  • I will now turn the call back to Oguzhan Atay to conclude.

    接下來我把電話交回 Oguzhan Atay 作結。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you, Ross. In summary, we are transforming healthcare, one molecule at a time, one patient at a time. Looking ahead, my confidence is rooted in the durability and scalability of the foundation we have built.

    謝謝你,Ross。總結來說,我們正以「一次一個分子、一次一位病人」的方式改變醫療照護。展望未來,我的信心來自於我們所建立基礎的持久性與可擴展性。

  • This is not a story dependent on one catalyst. It is a story of multiple reinforcing drivers working together over time.

    這不是一個依賴單一催化劑的故事。這是一個多個相互強化的驅動因素隨時間共同作用的故事。

  • Each product that we launch makes our platform more powerful, each study that we publish further validates the clinical utility of our technology. Each payer contract, including our landmark agreements with UnitedHealthcare and now Anthem. Strengthens access and reinforces the value of our offerings.

    我們推出的每一項產品都讓平台更強大;我們發表的每一項研究都進一步驗證我們技術的臨床效用。每一份付款方合約,包括我們與 UnitedHealthcare 的里程碑式協議,以及如今與 Anthem 的協議,都強化了可近性並鞏固了我們產品與服務的價值。

  • In Q1, we launched UnityConfirm, a first-of-its-kind offering that further differentiates our prenatal product portfolio, and we made important strides toward keeping our oncology product roadmap on track.

    在第一季,我們推出 UnityConfirm,這是一項同類首創的產品,進一步凸顯我們產前產品組合的差異化;同時,我們也在確保腫瘤產品路線圖按計畫推進方面取得重要進展。

  • We continued our strong revenue growth with 84% year-over-year growth. Leading to $434 million of annualized revenue run rate.

    我們延續強勁的收入成長,年增 84%。帶動年化收入 run rate 達 4.34 億美元。

  • We have combined this revenue growth with impressive gross margins of 73%, a 9-percentage-point year-over-year increase, even with subscale COGs and ASPs, especially in oncology.

    我們在實現收入成長的同時,也達成亮眼的 73% 毛利率,年增 9 個百分點;即便在成本(COGs)與 ASP 尚未達規模效益的情況下,尤其是在腫瘤領域。

  • Last but not least, we have shown that rapid growth. Does not have to come at the expense of profitability, achieving an impressive 16% GAAP operating margin and 24% adjusted EBITDA margin.

    最後但同樣重要的是,我們已證明快速成長不必以犧牲獲利為代價;我們達成了令人印象深刻的 16% GAAP 營業利益率與 24% 調整後 EBITDA 利潤率。

  • We are powered by a team of highly motivated, mission-driven individuals who show up every day with a shared purpose: to make a meaningful difference in patients' lives that dedication is reflected in the strength of our results and continues to drive our momentum.

    我們的動能來自一支高度積極、以使命為導向的團隊;大家每天帶著共同目標投入:為病患的生命帶來有意義的改變。這份投入反映在我們成果的強勁表現上,並持續推動我們的前進動能。

  • Looking ahead, our ambition remains clear: to build a category-defining company, earn a place in the S&P 500, transform molecular diagnostics, and help reshape healthcare.

    展望未來,我們的企圖心依然明確:打造一家具類別定義性的公司、躋身 S&P 500、改變分子診斷,並協助重塑醫療照護。

  • We are pleased with our progress to start the year and look forward to updating you as the year progresses. Thank you. Over to the operator.

    我們對今年開局的進展感到滿意,並期待在年度推進過程中持續向各位更新。謝謝。交給接線員。

  • Operator

    Operator

  • (Operator Instructions) Dan Arias, Stifel.

    (接線員指示) Stifel 的 Dan Arias。

  • Dan Arias - Analyst

    Dan Arias - Analyst

  • Hi, guys. Thanks for the questions here. Ross, maybe just to start on the guidance raise on revenues, is there a higher volume component embedded there? Is that really just a function of ASPs? And then can you maybe just talk a little bit to volume cadence over the course of the rest of the year here?

    嗨,各位。謝謝讓我在這裡提問。Ross,先從上調收入指引開始,這裡面是否包含更高的量(volume)因素?還是主要只是 ASP 的影響?另外,你能否談談今年剩餘期間量的節奏(cadence)?

  • Ross Taylor - Chief Financial Officer

    Ross Taylor - Chief Financial Officer

  • Sure, Dan. I made some reference to this in my prepared remarks, but in terms of the guidance increase, that came from the strength we had in Q1, just factoring that into the guidance as well as an ASP lift we expect to see from several additional payer contracts we entered into since the start of 2026.

    當然可以,Dan。我在事先準備的發言中有提到一些;就指引上調而言,主要來自我們第一季的強勁表現,把這部分納入指引之中,另外也包括我們預期自 2026 年初以來簽訂的數份新增付款方合約將帶來 ASP 的提升。

  • So not really assuming any increase in volume compared to our prior expectations other than the good results we saw in Q1, but primarily driven by lift in ASPs and, again, strong performance in Q1. Just in terms of cadence for volumes in the year, I think.

    因此,除了第一季看到的良好結果之外,我們並未真正假設相較先前預期會有任何量的增加;主要驅動因素是 ASP 的提升,以及再次強調第一季的強勁表現。至於今年量的節奏方面,我想。

  • The only real remark I would make there is we typically have a slower Q4 due to seasonality around the holidays and other factors, but other than that, I'd expect a little bit of sequential growth in Q2 and Q3, but Q4 is a seasonally slower quarter for us.

    我唯一想補充的是,由於假期等季節性因素與其他原因,我們第四季通常會較慢;除此之外,我預期第二季與第三季會有些許的季增,但第四季對我們而言是季節性較慢的一季。

  • Dan Arias - Analyst

    Dan Arias - Analyst

  • Okay, and then maybe on the gross margins, the step up there was pretty notable. We don't really even have a mid-70s number at all in our out-year forecast. So, how sustainable is that as new products come into the portfolio here?

    了解,那再問毛利率,這次的跳升相當明顯。我們在對未來年度的預測中甚至沒有任何一個中 70% 的數字。所以,隨著新產品納入產品組合,這樣的水準有多可持續?

  • At the very least, it feels like the 68, 69% assumption for this year seems low unless something is about to step down in the back half. So can you just maybe help us with that?

    至少就感覺而言,除非今年下半年有什麼因素要下滑,否則今年採用 68%、69% 的假設似乎偏低。所以你能不能幫我們釐清一下?

  • Ross Taylor - Chief Financial Officer

    Ross Taylor - Chief Financial Officer

  • Sure. You may have caught during our remarks, Ozon mentioned we expect 70% or better, gross margin over the course of the year. There could be a little bit of quarterly volatility in that, but I would expect that a 70% or better gross margin is something we can sustain for this calendar year.

    當然。你可能在我們的發言中有注意到,Ozon 提到我們預期全年毛利率可達 70% 或更高。其中可能會有一些季度性的波動,但我預期 70% 或更高的毛利率是我們在這個曆年可以維持的水準。

  • Dan Arias - Analyst

    Dan Arias - Analyst

  • Okay, thank you.

    好的,謝謝。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Dan, I can add a little bit of commentary around that with these contracts, especially including Anthem and UnitedHealthcare contracts, but other contracts as well that we are signing roughly 5 to 10 contracts almost every month now.

    Dan,我可以就這點補充一些評論,這些合約,特別是包含 Anthem 和 UnitedHealthcare 的合約,另外還有其他合約,我們現在大約幾乎每個月都會簽 5 到 10 份合約。

  • They're all incrementally helping our ASPs. Our prenatal, I think, is one of the most remarkable molecular diagnostics businesses in terms of gross margin.

    它們都在逐步提升我們的 ASP(平均售價)。我認為我們的產前業務,在毛利率方面是分子診斷業務中最突出的之一。

  • As without response, Medicare coverage, oncology. Has lower margins, and it is growing extremely fast, 25% quarter-over-quarter.

    至於(在)Medicare 給付涵蓋下的腫瘤業務。毛利率較低,但成長非常快,季對季成長 25%。

  • So, in the short-term, there is this dynamic between faster growth of oncology and remarkable gross margins of prenatal. So, that is going to keep further expansion, I think, in check, but we still expect it to be above 70%.

    所以短期內,腫瘤業務更快的成長與產前業務亮眼的毛利率之間,存在這樣的動態。因此我認為這會在一定程度上抑制毛利率進一步擴張,但我們仍預期會高於 70%。

  • Long-term, as both of these product lines mature, we expect both product portfolios to be easily above 75%. Percent.

    長期來看,隨著這兩條產品線都逐漸成熟,我們預期兩個產品組合的毛利率都能輕鬆超過 75%。百分比。

  • Operator

    Operator

  • Mark Massaro, BTIG.

    Mark Massaro,BTIG。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Hey, guys. Congrats on a strong quarter. I wanted to ask about UnityConfirm. Seems like a pretty interesting novel product offering.

    嗨,各位。恭喜本季表現強勁。我想問一下 UnityConfirm。看起來是一個相當有趣、創新的產品方案。

  • Oguzhan, how do you size this market? So even starting with, I think, 3.6 million. Births in the US, roughly, how many of them do you think would be eligible to go on to confirm this?

    Oguzhan,你怎麼估算這個市場規模?即使從美國每年大約 360 萬新生兒開始算起,你認為其中大概有多少會符合資格進一步做這個確認檢測?

  • And I think you're launching this later this month is this something that you expect to get expanded reimbursement coverage for as an add-on? And related to that, can you speak about the clinical trial that you're enrolling? How long do you think it'll take to enroll the patients in the study?

    另外我想你們會在這個月稍晚推出,這是否是你們預期能以加項(add-on)的方式擴大給付涵蓋的項目?以及相關地,你能談談你們正在招募的臨床試驗嗎?你認為完成收案大概要多久?

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you, Mark, for the question. In terms of reimbursement or revenue additions for the UnityConfirm, we expect that to be actually quite minimal, if any and the reason is that this is only going to be about 0.5 percent of the patients, maybe up to 1% of the patients who would test positive on a cell-free DNA test and be eligible for this. I think really the important part about UnityConfirm is that the patient is only able to get this test if they use UNITY aneuploidy.

    謝謝你,Mark,提出這個問題。就 UnityConfirm 的給付或營收增量而言,我們預期其實非常有限(如果有的話),原因是只有大約 0.5% 的病患,可能最多到 1% 的病患,會在無細胞 DNA 檢測呈陽性後符合資格使用這項檢測。我認為 UnityConfirm 真正重要的地方在於:病患只有在使用 UNITY 非整倍體(aneuploidy)檢測的情況下,才可以做這項檢測。

  • So we believe that this is going to make our aneuploidy offering strongly differentiated, and there will be an increased interest in using our UNITY aneuploidy platform over all others so that if there is a positive high-risk result, that the patient only then will be eligible to get tested with UnityConfirm, and having this exclusive.

    因此我們相信,這會讓我們的非整倍體產品形成強而有力的差異化,並提高市場對使用我們 UNITY 非整倍體平台、相較其他平台的興趣;如此一來,若出現陽性高風險結果,病患才會符合資格進一步使用 UnityConfirm 進行檢測,而這種排他性(exclusive)

  • About non-invasive confirmation for these high-risk pregnancies. We believe that this is going to be another driver of volume, not, in terms of the UnityConfirm volume alone, but because this is only the patients are only eligible for this if they used our aneuploidis screening as a frontline screen to begin with.

    針對這些高風險妊娠提供非侵入式確認。我們相信這會成為另一個帶動檢測量的驅動因素;不是因為 UnityConfirm 本身的量,而是因為只有先把我們的非整倍體篩檢作為第一線篩檢,病患才符合資格使用這項檢測。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • That's great. And then the timing for the clinical trial readout?

    很好。那臨床試驗讀出(readout)的時間點呢?

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • The timing, it is a very large clinical trial and the invasive testing in the United States actually has significantly decreased over time.

    時間點方面,這是一個非常大型的臨床試驗,而在美國侵入性檢測其實隨時間顯著下降。

  • So there are actually not as many patients as it used to. That are getting these invasive confirmations, which speaks to the, how critical this offering is, the clinical utility that it provides. But that also means that the timing of a very large clinical trial like this can easily take, anywhere between one to three years.

    所以實際上,接受這些侵入性確認檢測的病患數量不像以前那麼多。這也說明了這項產品的重要性,以及它所提供的臨床效用(clinical utility)。但這也意味著,像這樣非常大型的臨床試驗,時程很可能需要一到三年不等。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Right. And just to confirm, will these patients be measured against both amnio and CDS.

    了解。再確認一下,這些病患會同時以羊膜穿刺(amnio)和 CDS 作為對照衡量嗎?

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • So the clinical trial, as it is designed, includes both CVS and amniocentesis, but the primary endpoint, the primary utility is against CVS because it matches with the cell type that we are measuring, as well as the timeframe of the CVS that we are measuring.

    臨床試驗的設計同時包含 CVS(絨毛膜取樣)與羊膜穿刺(amniocentesis),但主要終點、主要效用是以 CVS 作為對照,因為它與我們測量的細胞類型相匹配,也與我們測量的 CVS 時間窗相匹配。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Perfect. And then last question for me nice to see Anthem come online. I think United started on April 1st, if you could confirm that. And what is the go-live date of Anthem?

    完美。最後一個問題:很高興看到 Anthem 上線。我想 United 是從 4 月 1 日開始,如果你能確認一下。那 Anthem 的正式上線日期是什麼時候?

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • United effective date was April 1. Anthem is already effective.

    United 的生效日是 4 月 1 日。Anthem 已經生效。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Fantastic. Thanks, guys.

    太好了。謝謝各位。

  • Operator

    Operator

  • Thank you. And our next question comes to the line of Andrew Brackmann from William Blair. Your question, please.

    謝謝。下一個問題來自 William Blair 的 Andrew Brackmann。請提問。

  • Andrew Brackmann - Analyst

    Andrew Brackmann - Analyst

  • Hi, Don. Ross, good afternoon. Thanks for taking the question. I also wanted to ask on UnityConfirm, can you maybe just sort of talk about the cell capture technology just broadly? What does this technology sort of mean to the entire prenatal genetics platform, and what are some of the future applications that this sort of unlock for you as you think years in advance? Thanks.

    嗨,Don。Ross,下午好。謝謝讓我提問。我也想問 UnityConfirm,你能否大致談談細胞捕捉(cell capture)技術?這項技術對整個產前遺傳平台意味著什麼?以及從更長期、以年為單位來看,它為你們解鎖了哪些未來應用?謝謝。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you, Andrew. This has been holy grail of prenatal testing, something that people have been working on for the last 20 years.

    謝謝你,Andrew。這一直是產前檢測的「聖杯」,人們在過去 20 年一直在努力。

  • Capturing these cells is extremely difficult. When we think about cell-free DNA testing, about five, 10% of the DNA is of fetal origin. When we think about, these prophoblasts, these fetal cells, it is truly one in a billion type of cell type.

    捕捉這些細胞極其困難。談到無細胞 DNA 檢測時,大約有 5% 到 10% 的 DNA 來源於胎兒。而談到這些滋養層細胞(trophoblasts)、這些胎兒細胞時,它真的是十億分之一等級的細胞類型。

  • So, it does -- it is a more labor-intensive and more actually difficult process, and that is why, this is positioned for confirmation of the high-risk cases rather than a frontline testing.

    所以,這確實——是一個更耗人力、也更困難的流程;也因此,這項產品被定位用於高風險個案的確認,而不是作為第一線檢測。

  • But as you can imagine, one of the really big limitations of cell-free DNA testing or even expansion of cell-free DNA testing was the concern around PPVs as you go into.

    但如你所想,無細胞 DNA 檢測的一個重大限制,甚至無細胞 DNA 檢測擴展的一個重大限制,是當你進入

  • The rare conditions, and having a non-invasive confirmation assay actually removes that concern, so I think from a long-term perspective, I don't see cell-based methodology as a replacement of cell-free DNA methodology, both due to the cost, but also due to kind of labor-intensive purposes of UnityConfirm or any other cell-based methodology, but it can really be.

    從長期角度來看,我不認為以細胞為基礎的方法會取代無細胞 DNA 方法,原因包括成本,也包括 UnityConfirm 或任何其他細胞式方法在操作上相對耗人力;但它確實可以

  • It can really solve the fundamental problems with cell-free DNA testing, which is this gap between screening and diagnostics, which has been increasing over time. And that can really enable us cell-free DNA testing to be more comprehensive and more widely adopted as well.

    它確實可以解決無細胞 DNA 檢測的根本問題,也就是篩檢與診斷之間的落差,而這個落差隨時間一直在擴大。這也能真正讓無細胞 DNA 檢測變得更全面,並更廣泛地被採用。

  • Andrew Brackmann - Analyst

    Andrew Brackmann - Analyst

  • That's very helpful. And then I just wanted to ask on capital allocation priorities. I think you caught up sort of maintaining profitability while still investing pretty heavily. So I assume cash should continue to grow from here. So how should we sort of be thinking about you guys using cash in capital allocations from here? Thanks.

    這非常有幫助。接著我想問一下資本配置的優先順序。我想你們提到的是在維持獲利能力的同時,仍然相當積極地投資。所以我推測現金部位接下來應該會持續增加。那麼我們應該如何看待你們從現在開始在資本配置上使用現金的方式?謝謝。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • As of right now, we do not have any specific plans about how to use the cash we expect to maintain our profitability while investing in various different areas.

    就目前而言,我們對於如何使用現金並沒有任何具體計畫;我們預期會在投資多個不同領域的同時,維持我們的獲利能力。

  • Andrew Brackmann - Analyst

    Andrew Brackmann - Analyst

  • Great. Thanks for the question.

    很好。謝謝你的提問。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you, Andrew.

    謝謝你,Andrew。

  • Operator

    Operator

  • Thank you. And the next question comes from the line of Subbu Nambi from Guggenheim. Your question, please.

    謝謝。下一個問題來自 Guggenheim 的 Subbu Nambi。請提問。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • Hey, guys. Thank you for taking my question. You mentioned the MRD launch is on track. What is the next tangible catalyst we should look out for? And if it is data, do you know the forum you will share it on either publication or conference.

    嗨,各位。謝謝讓我提問。你們提到 MRD 的上市進度如期。接下來我們應該留意的下一個具體催化劑是什麼?如果是數據,你們知道會透過哪個平台分享嗎?例如論文發表或會議。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • We will launch MRD with data at the time of the launch. So it's not going to be ahead of the launch, it is going to be at the time of the launch. I do not know whether it is going to be at a specific conference. It might be essentially a manuscript that we release.

    我們會在 MRD 上市時一併發布數據。所以不會在上市之前,而是會在上市當下。我不確定是否會在某個特定會議上發布。也可能基本上是我們發布的一篇手稿(manuscript)。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • Thank you for that. And just remind us of what is the response select ratio this quarter and separately. ACOG guidelines were updated last week. In light of that, how has prenatal reimbursement contracting progressed so far this year, especially for expanded carrier screening and 22Q, which depending on that, what are you expecting exiting 2026 and how might this shape your view for next year ASPs? Thank you.

    謝謝你的說明。另外請提醒我們,本季的 response 與 select 的比率是多少?以及另外一點:ACOG 指引上週更新。在此背景下,今年到目前為止產前檢測的給付合約談判進展如何,特別是擴增型帶因篩檢(expanded carrier screening)與 22Q?依此來看,你們對 2026 年底的狀況有何預期,又可能如何影響你們對明年 ASP 的看法?謝謝。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • We did not see any specific changes around coverage policies. We were able to get a network with more and more payers in Q1, and that is the primary contribution to our ASP growth right now.

    我們沒有看到任何與給付政策相關的特定變化。我們在第一季與越來越多的付款方建立了網絡合作,而這是目前我們 ASP 成長的主要貢獻來源。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • And what was the response with the select ratio difference?

    那 response 與 select 的比率是多少?

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Oh, it is similar. It's not changing. It's around [2212] response to one select is the rough ratio that we see, but each physician uses differently. Some physicians are repeating select and response, so it is one-to-one ratio.

    喔,差不多。沒有變。我們看到的大致比率約是每 1 個 select 對應約 [2212] 個 response,但每位醫師的使用方式不同。有些醫師會重複做 select 和 response,所以是一比一。

  • And then other physicians are doing, one select, one response to begin with, and then following up with, two or three or four response tests until they see progression and at that point, they are using a select test, but the blended average is staying at two response to one select test, which really speaks to the.

    另外一些醫師一開始會做 1 次 select、1 次 response,之後再追蹤做 2 次、3 次或 4 次 response 檢測,直到看到疾病進展;到那個時點他們會再使用一次 select 檢測。但加權後的平均仍維持在每 1 個 select 對 2 個 response,這其實反映了……

  • The value of a Medicare coverage of a response test for us. So that is why, we have been working diligently on that front.

    對我們而言,Medicare 對 response 檢測給付覆蓋的價值。所以這也是為什麼我們一直在這方面努力推進。

  • Subbu Nambi - Equity Analyst

    Subbu Nambi - Equity Analyst

  • Very helpful. Thank you.

    非常有幫助。謝謝。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Thank you. And our next question comes from the line of Casey Woodring from J.P. Morgan. Your question, please.

    謝謝。下一個問題來自 J.P. Morgan 的 Casey Woodring。請提問。

  • Casey Woodring - Analyst

    Casey Woodring - Analyst

  • Hi, this is Sebastian Sandler on for Casey. Thanks for taking the question. My first question is on the sales rep ramp.

    嗨,我是代 Casey 提問的 Sebastian Sandler。謝謝讓我提問。我的第一個問題是關於業務代表的上手(ramp)進度。

  • Can you share the fully ramped rep count as of 1Q and then your latest expectations for fully productive reps exiting the year? And if you have this by prenatal and oncology, that would be super helpful. And then just any other color on how the process of getting these reps fully ramped is progressing. Is it taking more or less time compared to your initial expectations? Thank you.

    你們能分享截至第一季,已完全上手(fully ramped)的業務代表人數嗎?以及你們對年底前完全具生產力(fully productive)的業務代表人數最新預期為何?如果能按產前與腫瘤兩個業務線拆分會非常有幫助。另外也想請你們補充一些細節:這些業務代表達到完全上手的進程目前如何?相較於你們最初的預期,所需時間是更長還是更短?謝謝。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you, Casey. The numbers that we shared in the March earnings call, we are approximately on track to those numbers.

    謝謝你,Casey。我們在 3 月的財報電話會議中分享的數字,目前大致都在軌道上。

  • We are not going to share at every quarter how many exactly ramped up reps that we have, but their productivity is staying within the expectations that we have had from the past quarters.

    我們不會每一季都揭露到底有多少位業務代表已完全上手,但他們的生產力仍維持在我們過去幾季所預期的範圍內。

  • Casey Woodring - Analyst

    Casey Woodring - Analyst

  • Great. Thanks. And then on oncology ASPs, it looked like those stepped down a touch sequentially. I'm assuming this might have been on the NorthStar Select side, maybe from true reps rolling off.

    了解。謝謝。接著關於腫瘤業務的 ASP,看起來季比略有下滑。我猜這可能是在 NorthStar Select 端,例如先前的 true reps 逐步退出所致。

  • So if you could give us more color on that and then just ASP progression for the rest of the year, should this be pretty stable or do you expect to be more back half weighted as some of these new contracts start kicking in? Thank you.

    如果可以的話,請多給我們一些背景說明;另外就今年剩餘時間的 ASP 走勢而言,應該會相當穩定嗎?還是你們預期會更偏向下半年,因為一些新合約開始生效?謝謝。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • I believe the oncology ASPs were primarily, excluding throughout, they were very similar, throughout number changes from quarter to quarter, and it can impact essentially exactly what it is being recognized that. But there are no material changes in how our oncology tests are being paid. North Star Select has.

    我認為腫瘤 ASP 主要是——撇除 throughout 的影響——其實非常相近;throughout 的數字每季會變動,可能會影響到最終被認列的確切金額。但我們的腫瘤檢測在支付方式上沒有任何重大變化。North Star Select 已經……

  • Broad coverage and reimbursement, and NorthStar Response does not. So, we expect, NorthStar Response ASV to be significantly higher once we have Medicare coverage of NorthStar Response, which will only come in around towards the end of the year.

    具有廣泛的覆蓋與給付,而 NorthStar Response 則沒有。因此我們預期,一旦 NorthStar Response 取得 Medicare 覆蓋,NorthStar Response 的 ASP 將會顯著提高;而這大概只會在接近年底時才會發生。

  • Casey Woodring - Analyst

    Casey Woodring - Analyst

  • Makes sense. Thank you.

    了解。謝謝。

  • Operator

    Operator

  • Thank you. And our next question comes from the line of David Westenberg from Piper Sandler. Your question, please.

    謝謝。下一個問題來自 Piper Sandler 的 David Westenberg。請提問。

  • Unidentified Participant

    Unidentified Participant

  • Hi, this is [Sky] on for Dave. Thanks for taking the question. Maybe just on the health system pipeline, where does that stand today? Our health system, our health system-related adoption is still not embedded in the guide. Thanks.

    嗨,我是代 Dave 提問的 [Sky]。謝謝讓我提問。想請教一下醫療體系(health system)管線目前的狀況如何?我們的醫療體系、與醫療體系相關的採用情況仍未納入指引(guide)之中。謝謝。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • The health system adoption. Is something that, we work on, but the timeline for health system adoptions can be very variable.

    醫療體系的採用。是我們正在推進的事項,但醫療體系導入的時間表可能差異很大。

  • So it is not directly embedded in the guide except for essentially any sales team members that we had are expected to grow their territory by a set amount, and those are embedded in the guide as a standard for our previous projections.

    因此它並未直接納入指引之中;除了我們現有的銷售團隊成員,預期各自的區域會以固定幅度成長,而這些已作為我們先前預測的標準而納入指引。

  • Unidentified Participant

    Unidentified Participant

  • Got it. Okay, thanks. And then next, just a little bit more color on how you see cancer monitoring adoption over the next few years and timing on that. Thank you.

    了解。好的,謝謝。接著,能否再多談一些你們如何看待未來幾年癌症監測的採用情況,以及相關時程?謝謝。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Can you repeat the question?

    你可以重複一下問題嗎?

  • Unidentified Participant

    Unidentified Participant

  • Yes. How do you see cancer monitoring adoption kind of over the next few years and the timing around that?

    可以。你們如何看待未來幾年癌症監測的採用情況,以及相關時程?

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • You mean NorthStar Response related adoption when you say cancer monitoring, or are you referring to more surveillance with respect to MRD?

    你說的癌症監測,是指 NorthStar Response 相關的採用嗎?還是你指的是與 MRD 相關、偏向監測(surveillance)的應用?

  • Unidentified Participant

    Unidentified Participant

  • More surveillance with respect to MRD would be great, so?

    如果能談談與 MRD 相關、偏向監測(surveillance)的部分就很好,所以?

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Today, we do not have an MRD test, but, we are working on building a tumor-naive MRD test. And our belief there is that today, most of the usage of MRD is in academic centers, and it is primarily in colorectal cancer and that is one area where.

    目前我們還沒有 MRD 檢測,但我們正在開發一個不需要腫瘤樣本(tumor-naive)的 MRD 檢測。我們的看法是,目前 MRD 的使用多集中在學術醫學中心,且主要在大腸直腸癌領域,而那是其中一個領域……

  • Access to tissue is much easier than other cancer types. We believe that the adoption of a tumor-naive test that is as sensitive, if not more sensitive, than many of the tumor-informed tests will be much more easily adopted in, by community oncologists who care for upwards of 80 plus percent of oncology lives in the United States.

    取得組織樣本比其他癌症類型容易得多。我們相信,採用一種對腫瘤不知情(tumor-naive)的檢測,其靈敏度不亞於、甚至高於許多對腫瘤知情(tumor-informed)的檢測,將更容易被社區腫瘤科醫師所採用;這些醫師照護了美國超過 80% 的腫瘤患者。

  • So we believe that, even though most of the adoption today is in colorectal and most of the adoption is in academic centers, eventually the bigger adoption of MRD is going to be in community, by community oncologists using tumor naive tests and that is why we spend a lot of our efforts around the tumor-naive aspect of our test, even though it is so much easier to build a tumor-informed test. In fact, internally, we built a tumor-informed test that is ultra-sensitive just so that we can benchmark our tumor-naive test against it.

    因此我們認為,儘管目前多數採用發生在大腸直腸癌領域、且多數採用集中在學術中心,但最終 MRD 更大規模的採用將會發生在社區端,由社區腫瘤科醫師使用腫瘤不知情的檢測;這也是為什麼我們把大量精力投入在我們檢測的腫瘤不知情面向,即便打造一個對腫瘤知情的檢測要容易得多。事實上,我們內部也建立了一個超高靈敏度的對腫瘤知情檢測,只是為了能用它來對照(benchmark)我們的腫瘤不知情檢測。

  • Unidentified Participant

    Unidentified Participant

  • Very helpful. Thank you.

    非常有幫助。謝謝。

  • Operator

    Operator

  • Thank you. And our next question comes from the line of Brandon Couillard from Wells Fargo. Your question, please.

    謝謝。下一個問題來自富國銀行(Wells Fargo)的 Brandon Couillard。請提問。

  • Brandon Couillard - Equity Analyst

    Brandon Couillard - Equity Analyst

  • Hey, thanks. Good afternoon. Just two questions for you, Ross. Just want to confirm to what extent, other than the first quarter true-ups, have you embedded any additional true-ups over the balance of the year in the new guide? And then could you speak to the spike in the accounts receivable in the first quarter? Thanks.

    嗨,謝謝。下午好。Ross,我有兩個問題。我想確認一下:除了第一季的追溯調整(true-ups)之外,在新的指引中,你們是否在今年剩餘期間還納入了任何額外的追溯調整?另外,你能談談第一季應收帳款(accounts receivable)的激增嗎?謝謝。

  • Ross Taylor - Chief Financial Officer

    Ross Taylor - Chief Financial Officer

  • Sure. With regard to the true-ups, yes, we do not include true-up revenue in the guide other than the historical, kind of Q1 numbers we've already seen. So, the out quarters, no, there's no true-up revenue embedded in that guide.

    當然。關於追溯調整,是的,我們在指引中不包含追溯調整收入,除了我們已經看到的歷史數據,也就是第一季那類數字。所以在後續季度,不,該指引中沒有內含任何追溯調整收入。

  • The change in AR is, we entered into, a number of contracts, Q1, some of which came in late Q1 as well, and we're not going to get reimbursement for those until several months from now and some of that new contracting drove about half of the increase in our AR this quarter, or almost half of the increase in the AR. So, I would expect that will come down, if not, by the end of Q2, certainly by the end of Q3. It just depends on how rapid these activities.

    應收帳款的變動是因為我們在第一季簽訂了多份合約,其中一些也在第一季末才生效,而這些合約的報銷要到幾個月後才會收到;部分新簽約帶動了本季應收帳款增加的大約一半,或接近一半。因此我預期它會下降;若不是在第二季末,也會在第三季末之前。這取決於這些活動推進的速度有多快。

  • Brandon Couillard - Equity Analyst

    Brandon Couillard - Equity Analyst

  • Very helpful. Thank you.

    非常有幫助。謝謝。

  • Operator

    Operator

  • Thank you. And our next question comes from the line of Tycho Peterson from Jefferies. Your question, please.

    謝謝。下一個問題來自 Jefferies 的 Tycho Peterson。請提問。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • Hey, I'd love to dig into the 1Q volumes a bit. You called out an increase in active ordering providers last quarter. Could you maybe just touch on how much of the volume contributions this quarter came from new providers versus repeat orders from previously integrated providers?

    嗨,我想更深入了解一下第一季的檢測量。你提到上季活躍下單的醫療提供者(ordering providers)增加。你能否談談本季的量增中,有多少來自新提供者的貢獻, versus 先前已整合的提供者的重複下單?

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you, Tycho, for the question. We have seen a very similar number of newly active ordering providers that we added in this quarter compared to all the previous quarters.

    謝謝你,Tycho,這個問題。我們本季新增的「新近活躍下單提供者」數量,與過去各季非常相近。

  • So we haven't seen any difference. Really, the difference between test volume increases between quarters is primarily due to the number of accessioning days in the quarter and when those providers essentially become active.

    所以我們沒有看到任何差異。實際上,各季之間檢測量增加的差異,主要取決於該季度的收件建檔(accessioning)天數,以及這些提供者何時開始實際變得活躍。

  • Throughout the quarter. So we haven't actually seen any difference between Q4 and Q1, it is just that Q4 tends to be seasonally slow for us due to the number of accessioning days and the holidays in the quarter, which artificially decreases the test volume.

    在整個季度期間。因此我們其實沒有看到第四季與第一季之間有任何差異;只是第四季因為收件建檔天數以及季度內的假期,對我們而言通常是季節性較慢,這會人為地降低檢測量。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • Okay, and then, you've had a couple on UnityConfirm, I guess. I'm just wondering how you're thinking about share dynamics, in the market today. There have obviously been some competitive, launches as well. What's your view of share dynamics today?

    好的,另外,你們在 UnityConfirm 上好像有一些進展。我想知道你們如何看待目前市場上的市占動態。顯然也有一些競品推出。你對目前的市占動態有何看法?

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • We are not really seeing a significant impact in the way that we are acquiring new providers, new accounts. UnityConfirm, granted it does create some noise, but just the fact that we have added a similar number of active ordering providers, newly active ordering providers in Q1, as well as Q4, as well as Q3, similar to the previous quarters, really shows that our products are resonating with providers and we are executing well. But UnityConfirm is another driver, another reason for providers to use our test.

    我們並沒有看到在獲取新提供者、新客戶的方式上有顯著影響。UnityConfirm 的確會帶來一些雜訊,但我們在第一季新增的活躍下單提供者數量,與第四季、第三季以及之前各季相近,這其實顯示我們的產品正在引起提供者共鳴,而且我們執行得很好。不過 UnityConfirm 也是另一個驅動因素、另一個讓提供者使用我們檢測的理由。

  • As opposed to some of our previous launches, in this particular case, it is only accessible if a provider has ordered Unity aneuploidy as a frontline screen, which we believe is going to position our test as much more of a frontline usage in certain cases where they may be relying on our test as a second line in the past. This certainly happens, for instance, with MFMs.

    相較於我們先前的一些產品推出,這一次的情況是:只有當提供者將 Unity 非整倍體(aneuploidy)作為第一線篩檢(frontline screen)下單時,才可使用 UnityConfirm;我們相信這將使我們的檢測在某些情境下更偏向第一線使用,因為過去他們可能把我們的檢測當作第二線使用。例如在母胎醫學專科(MFM)就確實會發生這種情況。

  • Sometimes, with our fetal antigen testing, we would receive another aneuploid order, even though frontline testing was, another competitor's test. Or similarly, we do receive tests where are aneploidies being ordered because other tests were no calls or were incorrect results. In this particular case, we are only enabling UnityConfirm if our test has been used as a frontline test, which essentially means that it will be an important driver of test volume.

    有時候,針對我們的胎兒抗原檢測,我們會收到另一張非整倍體的訂單,即便第一線檢測其實是另一家競品的檢測。或者同樣地,我們也會收到非整倍體檢測的訂單,因為其他檢測出現無法判讀(no call)或結果不正確。而在這個特定情況下,只有當第一線使用的是我們的檢測時,我們才會啟用 UnityConfirm;這基本上意味著它將成為推動檢測量的重要驅動因素。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • Okay. And then last one, understanding the timelines for MOLD-X on NorthStar response. We hear a lot about potential delays of MOLD-X and, longer times to turn new applicants. I guess, what's the risk it gets pushed into next year?

    了解。最後一個問題,關於 MOLD-X 對 NorthStar 回覆的時程理解。我們聽到很多關於 MOLD-X 可能延遲、以及新申請案審轉時間變長的說法。我想問,是否有風險會被推遲到明年?

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • We are not seeing any issues with MOLD-X. They are responding within their state of timelines, which is 60 days and it was a very productive, back and forth with multi-X. So we do not anticipate any potential for delay. It might even potentially be slightly earlier than we originally anticipated.

    我們沒有看到 MOLD-X 有任何問題。他們在其既定時程內回覆,也就是 60 天,而且與 MOLD-X 的往返溝通非常有效率。因此我們不預期會有任何延遲的可能性。甚至可能會比我們原先預期的稍早一些。

  • Tycho Peterson - Analyst

    Tycho Peterson - Analyst

  • Okay. Thank you.

    好的。謝謝。

  • Operator

    Operator

  • Thank you. This does conclude the question-and-answer session of today's program. I'd like to hand the program back to Oguzhan Atay for any further remarks.

    謝謝。今天節目的問答環節到此結束。我想把會議交回給 Oguzhan Atay,請他做進一步的結語。

  • Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

    Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder

  • Thank you, operator, and thank you all for joining today's conference call. We look forward to speaking with you on our next conference call in a few months. Have a good day.

    謝謝接線員,也謝謝各位參加今天的電話會議。我們期待在幾個月後的下一次電話會議再與各位交流。祝各位有美好的一天。

  • Operator

    Operator

  • Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.

    謝謝各位女士先生參與今天的會議。本節目到此結束。您現在可以掛線。祝您有美好的一天。