BillionToOne, Inc. (BLLN) 2026 Q2 法說會逐字稿

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  • Operator

    Operator

  • Good day, and thank you for standing by. Welcome to the BillionToOne second quarter 2026 earnings call. (Operator Instructions) Please be advised that this conference is being recorded. I would now like to turn the conference over to your speaker today, Gabby Gable, Investor Relations. Please go ahead.

    大家好,感謝您稍候。歡迎參加 BillionToOne 2026 年第二季財報電話會議。(接線員指示) 請注意,本次會議將被錄音。現在我想把會議交給今天的發言人,投資人關係 Gabby Gable。請開始。

  • Gabriella Capell - Investor Relations

    Gabriella Capell - 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 second quarter ended June 30, 2026. A copy of the press release is available on the company’s website.

    各位下午好。感謝各位參與今天的電話會議。今天與我一同出席電話會議的 BillionToOne 代表包括: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 6 月 30 日止第二季的財務結果。新聞稿副本可於公司網站取得。

  • 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. 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.

    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》所定義的範圍內發表前瞻性陳述。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/報銷涵蓋範圍、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. Risk factors that may cause our results to differ are discussed in our filings with the SEC, including our previously filed annual report on 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.

    我們提醒您,此類陳述反映的是我們目前最佳判斷,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。可能導致我們結果不同的風險因素,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 Form 10-K 年度報告、將於本次電話會議後提交的 Form 10-Q 季度報告,以及今日提交的 Form 8-K 當前報告。

  • Any forward-looking statement made during this call is made as of today, August 5, 2026. If this call is replayed or reviewed after today, the information made during this call may not contain current or accurate information. BillionToOne 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,均以今日(2026 年 8 月 5 日)為準。若在今日之後重播或回顧本次電話會議,本次會議所提供的資訊可能不再是最新或準確的資訊。除法律要求外,BillionToOne 不承擔公開更新任何前瞻性陳述的義務,不論係因新資訊、未來事件或其他原因。

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

    接下來,我把電話會議交給 Ozan。

  • 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 second quarter 2026 earnings call. I would like to start by thanking our patients and providers who trust us with incredibly important healthcare decisions and our employees who show up every day with tremendous effort to build and deliver superior tests that improve our patients’ care and remove the fear of the unknown.

    各位下午好。感謝各位參加我們 2026 年第二季財報電話會議。我想先感謝我們的病患與醫療服務提供者,他們在極其重要的醫療決策上信任我們;也感謝每天全力以赴的員工,打造並交付更優質的檢測,改善病患照護,並消除對未知的恐懼。

  • Before diving into our quarterly results, I would like to remind you of the four pillars that I believe make us a different category of molecular diagnostics company. The first pillar is our revolutionary technology platform, enabled by our patented QCT, Quantitative Counting Template technology. Our technology achieves single-molecule level sensitivity and precision with next-generation sequencing. This has allowed us to build unique category-defining products in both prenatal and oncology.

    在深入說明本季業績之前,我想提醒各位,我認為使我們成為不同類別分子診斷公司的四大支柱。第一個支柱是我們革命性的技術平台,由我們已獲專利的 QCT(Quantitative Counting Template,定量計數模板)技術所驅動。我們的技術結合次世代定序,達到單分子層級的靈敏度與精準度。這使我們能在產前與腫瘤兩大領域打造出獨特、可定義品類的產品。

  • In turn, in our second pillar, our products have allowed us to scale rapidly from 0 to $438 million in annualized revenue run rate in six years. But we believe we are still in the early days, perhaps at less than 1% of what is possible, as we believe prenatal and oncology cell-free DNA testing can exceed an estimated $100 billion in the United States alone.

    進一步而言,在第二個支柱上,我們的產品讓我們在六年內快速擴張,年化營收運行率從 0 成長至 4.38 億美元。但我們認為仍處於早期階段,可能僅達到可實現規模的不到 1%;因為我們相信,僅在美國,產前與腫瘤的無細胞 DNA 檢測市場規模就可超過預估的 1,000 億美元。

  • Importantly, in our third pillar, with the higher signal-to-noise advantage that our unique technology offers us, and with our relentless focus on COGS reductions and ASP growth, we have been able to couple our rapid growth with a superior gross margin profile. We now have margins above 70%, with still significant room for expansion through ASP growth and COGS per test reductions.

    重要的是,在第三個支柱上,憑藉我們獨特技術所帶來更高的訊噪比優勢,以及我們對降低銷貨成本(COGS)與提升平均售價(ASP)的不懈專注,我們得以在快速成長的同時,維持更優異的毛利率結構。我們目前毛利率已超過 70%,且仍有顯著擴張空間,可透過 ASP 成長與每次檢測 COGS 降低來實現。

  • Finally, this superior gross margin, combined with a culture of fiscal discipline and efficient operations incorporating AI, has allowed us to achieve GAAP profitability. We have done this at a much lower scale than our public competitors, with an accumulated deficit that is approximately 10% of theirs.

    最後,這樣的優異毛利率,加上財務紀律與高效率營運文化(並導入 AI),使我們得以達成 GAAP 獲利。我們在遠低於上市同業的規模下做到這一點,且我們的累積虧損約為他們的 10%。

  • In summary, we continue to track toward our long-term goal, which has remained the same, to build a category-defining generational company, transform molecular diagnostics and the standard of care for millions of patients, and become a member of the S&P 500.

    總結而言,我們持續朝向長期目標邁進,而該目標始終不變:打造一家可定義品類、具世代影響力的公司,改變分子診斷與數百萬病患的照護標準,並成為標普 500 指數成分股。

  • Our second quarter performance was strong across all pillars as we delivered another quarter with high growth, excellent margins, and positive operating income and cash flow. I will cover each pillar in more detail, to summarize, we are launching new products both in prenatal and oncology, and we have published data that we believe will support MolDX coverage for Northstar Response.

    我們第二季在所有支柱上的表現都很強勁,再次交出高成長、優異毛利率,以及正向營業利益與現金流的一季。我將更詳細說明各支柱;概括而言,我們在產前與腫瘤領域皆推出新產品,並發布了我們認為可支持 Northstar Response 取得 MolDX 給付涵蓋的數據。

  • Our rapid growth continued with test volume up 35% year-over-year and revenue up 64% year-over-year. We maintained our superior gross margin profile, which was 70.5% in the quarter, an expansion of five percentage points year-over-year. Our gross margins stayed remarkably consistent in the past few quarters despite an increase in COGS per test as our mix shifts toward a higher proportion of oncology tests.

    我們的快速成長持續,檢測量年增 35%,營收年增 64%。我們維持優異的毛利率結構,本季毛利率為 70.5%,較去年同期擴張 5 個百分點。儘管因產品組合轉向較高比例的腫瘤檢測而使每次檢測的 COGS 上升,我們在過去幾季的毛利率仍保持驚人的一致性。

  • And lastly, even as we accelerated our investments in commercial scale and R&D, we maintained a strong level of profitability, achieving $5.5 million of GAAP operating income, a 5% operating margin, and a remarkable 15% adjusted EBITDA margin. As a result, we increased our cash position to $549 million at the end of the quarter.

    最後,即使我們加速在商業化規模與研發上的投資,我們仍維持強勁的獲利水準,達成 550 萬美元的 GAAP 營業利益、5% 的營業利益率,以及亮眼的 15% 調整後 EBITDA 利潤率。因此,我們在季末的現金部位提升至 5.49 億美元。

  • Let me take you through the quarter pillar by pillar. Starting with our first pillar, our platform and products. In prenatal, Unity Confirm has seen strong adoption following the launch on May 28. As a reminder, it is the first and only non-invasive confirmation assay for high-risk pregnancies. It captures and sequences intact circulating fetal cells to provide 100% fetal fraction, a fundamentally different category from conventional cell-free DNA tests.

    接下來我將按支柱逐一帶各位回顧本季。先從第一個支柱:我們的平台與產品。在產前領域,Unity Confirm 自 5 月 28 日上市以來,採用情況強勁。提醒各位,它是首個也是唯一用於高風險妊娠的非侵入性確認檢測(confirmation assay)。它可捕捉並定序完整的循環胎兒細胞,以提供 100% 胎兒比例(fetal fraction),在本質上與傳統無細胞 DNA 檢測屬於完全不同的類別。

  • We launched it as a specialized follow-on for high-risk pregnancies identified on our Unity Aneuploidy Screen. Unity Confirm gives patients who cannot or choose not to proceed to invasive diagnostic testing a non-invasive option they didn’t have before, at a sensitive time when options may feel limited.

    我們將其作為專門的後續檢測,適用於在我們 Unity Aneuploidy Screen 中被識別為高風險的妊娠。對於無法或選擇不進行侵入性診斷檢測的病患,Unity Confirm 提供了先前不存在的非侵入性選項;在那樣敏感的時刻,選項往往會讓人感到有限。

  • The early reception of Unity Confirm has been exceptional. Providers are already ordering Unity Confirm on more than 50% of their eligible high-risk Unity Aneuploidy patients. We also continue to enroll patients in what we believe is the largest prospective circulating fetal cell-based study ever conducted.

    Unity Confirm 的早期市場反應非常出色。醫療提供者已在其符合條件的高風險 Unity Aneuploidy 病患中,超過 50% 會開立 Unity Confirm。我們也持續招募病患,進行我們認為是迄今規模最大的前瞻性循環胎兒細胞研究。

  • In the meantime, Unity Confirm is opening doors even to no-see health systems that typically do not allow any sales reps. We expect its long-term impact for the Unity franchise to be significant, especially as future readouts from the study mature, and it is established as the next paradigm in non-invasive testing.

    同時,Unity Confirm 甚至為那些通常不允許任何業務代表進入的醫療體系打開了大門。我們預期它對 Unity 產品線的長期影響將相當顯著,特別是隨著該研究未來讀出結果逐步成熟,並且它被確立為非侵入性檢測的下一個典範。

  • Our prenatal product engine did not stop there. On August 17, we are expanding our UNITY Fetal Risk Screen to 130 genes, the largest panel on the market that doesn’t rely on partner testing, by far leapfrogging competitive offerings. Approximately 50% of all providers prefer large panels for these inherited conditions.

    我們的產前產品引擎並未止步於此。在 8 月 17 日,我們將把 UNITY Fetal Risk Screen 擴增至 130 個基因,這將是市場上最大、且不依賴合作夥伴檢測的檢測面板,並將大幅超越競品方案。約有 50% 的醫療提供者偏好針對這些遺傳性疾病使用大型面板。

  • So we believe that this expansion will meaningfully increase our serviceable market. The panel screens for prevalent actionable conditions selected from ACOG, ACMG, and RAST guidelines, and it reinforces Unity’s position as the leader in cell-free DNA testing for recessive conditions.

    因此,我們相信這項擴增將顯著提升我們可服務的市場規模。該檢測面板依據 ACOG、ACMG 與 RAST 指引所選定的常見且可採取行動的疾病進行篩檢,並進一步鞏固 Unity 在隱性遺傳疾病無細胞 DNA 檢測領域的領導地位。

  • Turning to oncology, we generated important new clinical evidence this quarter. On June 24, we published a peer-reviewed study in the Journal of Liquid Biopsy validating Northstar Response for monitoring immunotherapy and immuno combination therapy. This study included 142 patients and more than 750 samples across two prospective cohorts and 12 tumor types.

    轉向腫瘤領域,本季我們產出了重要的新臨床證據。6 月 24 日,我們在《Journal of Liquid Biopsy》發表一項經同儕審查的研究,驗證 Northstar Response 可用於監測免疫治療與免疫聯合治療。該研究納入 142 名患者,涵蓋兩個前瞻性隊列與 12 種腫瘤類型,並分析超過 750 份樣本。

  • Molecular progression strongly predicted worse survival, notably a stronger predictor than imaging alone and stronger still when the two were combined. The test also separated radiographically stable patients into true responders and non-responders, further demonstrating value over standard of care imaging. This publication is designed to support our pursuit of MolDX Medicare coverage for Northstar Response in the IO and IO combination therapy settings.

    分子層面的疾病進展(molecular progression)能強烈預測較差的存活率,且其預測力明顯強於僅依賴影像檢查;兩者合併時預測力更強。該檢測亦可將影像學上穩定的患者區分為真正反應者與無反應者,進一步顯示其相較於標準照護影像檢查的價值。此篇發表旨在支持我們在 IO 與 IO 聯合治療情境下,為 Northstar Response 申請 MolDX Medicare 給付。

  • Since response accounts for almost two-thirds of our oncology test volume, this coverage remains one of our most meaningful catalysts and is still expected by the end of this year. Speaking of catalysts, we remain on track for our highly sensitive tumor-naive MRD launch by the end of the year as well.

    由於「反應(response)」約占我們腫瘤檢測量的近三分之二,這項給付仍是我們最重要的催化劑之一,且仍預期於今年底前取得。談到催化劑,我們也仍按計畫在今年底前推出高靈敏度、腫瘤未知(tumor-naive)的 MRD 產品。

  • It is important to note that our liquid biopsy assays have a QCT failure rate below 1%, compared to 15% to 30% typical of assays that require tissue sequencing. We are also updating Northstar Select on September 1 in two important ways.

    需要特別指出的是,我們的液體活檢檢測其 QCT 失敗率低於 1%,相較之下,需要進行組織定序的檢測,其典型失敗率約為 15% 至 30%。我們也將於 9 月 1 日以兩項重要方式更新 Northstar Select。

  • First, we are expanding the panel to 102 genes to cover recent and upcoming FDA therapy approvals, including the highly sensitive detection of MTAP copy number loss. MTAP loss is present in approximately 15% of all cancer patients and is the target of several promising ongoing clinical trials. As we previously discussed, copy number losses are extremely difficult to detect in liquid biopsy, a problem that our technology resolves.

    第一,我們將面板擴增至 102 個基因,以涵蓋近期與即將到來的 FDA 治療核准項目,其中包括對 MTAP 拷貝數缺失的高靈敏度偵測。MTAP 缺失約存在於 15% 的所有癌症患者中,且是多項具前景、正在進行的臨床試驗之標的。如我們先前所述,拷貝數缺失在液體活檢中極難偵測,而我們的技術可解決此一問題。

  • Second, we are launching Northstar Origin, a tissue of origin add-on, which we believe will deliver best-in-class performance. With higher call rates than any similar offering. Roughly 3% of patients present with cancer of unknown primary, which results in a lack of effective therapy options. Moreover, the percentage of patients with uncertain diagnoses can reach 10% in community oncology settings, especially when they do not have access to detailed pathology workups.

    第二,我們將推出 Northstar Origin(原發組織來源)加購項目,我們相信其將提供同級最佳的表現。其判定率(call rates)高於任何類似產品。約有 3% 的患者為原發不明癌(cancer of unknown primary),導致缺乏有效的治療選項。此外,在社區腫瘤照護環境中,診斷不確定的患者比例可達 10%,尤其是當他們無法取得更完整的病理檢查時。

  • Northstar Origin uses QCT-based molecular counting of methylation to deliver 91% top 3 and 86% top 1 accuracy in identifying the tissue of origin, helping these patients get to a diagnosis and effective therapy. Turning to our second pillar, scalable rapid growth. In the second quarter, total test volume grew 35% year-over-year to approximately 196,000 tests, up approximately 8,000 sequentially. Our growth was in line with our expectations for prenatal and above expectations for oncology.

    Northstar Origin 透過以 QCT 為基礎的甲基化分子計數,在辨識原發組織來源方面可達到 Top 3 準確率 91% 與 Top 1 準確率 86%,協助這些患者獲得診斷並接受有效治療。接著談我們的第二支柱:可擴展的快速成長。第二季總檢測量年增 35% 至約 196,000 次,較前一季增加約 8,000 次。我們的成長符合對產前檢測的預期,且腫瘤檢測表現優於預期。

  • Importantly, we added approximately 70 sales representatives in the first half of the year, ahead of our plan, given the strength of our hiring pipeline. While this rate of hiring did have some impact on our short-term sales productivity, we expect our hiring to translate into faster growth exiting the year and into the early part of the next year, as these representatives become fully productive and penetrate the health systems, especially as these health systems also become EMR-integrated.

    重要的是,我們在上半年新增約 70 名業務代表,因招募管道強勁而超前原定計畫。雖然此一招募速度確實對短期銷售生產力造成一些影響,但我們預期隨著這些代表全面進入產能並深入各醫療體系(尤其是當這些醫療體系也完成 EMR 整合後),招募將轉化為今年底及明年初更快的成長。

  • Speaking of EMR integrations, we launched on Epic Aura platform in under five months, a record speed for any laboratory to launch on Epic Aura, and completed our first Aura health system integration in just two weeks from start to first test order. Epic Aura removes a critical barrier to health system adoption.

    談到 EMR 整合,我們在不到五個月內於 Epic Aura 平台上線,創下任何實驗室在 Epic Aura 上線的最快速度,並在啟動後僅兩週即完成第一個 Aura 醫療體系整合並產生第一筆檢測訂單。Epic Aura 移除了醫療體系採用上的一項關鍵障礙。

  • It will still take time to convert health systems, since each health system’s IT team must slot our integration into a roadmap that is often two to four quarters out. We expect the impact to be meaningful as we enter next year.

    醫療體系的轉換仍需要時間,因為各醫療體系的 IT 團隊必須將我們的整合排入其路線圖,而該路線圖往往落在未來兩到四個季度。我們預期其影響將在進入明年時變得顯著。

  • Given how quickly our oncology tests are scaling, we also signed a lease for a dedicated 62,000-square-foot oncology production lab directly across from our existing prenatal production lab in Union City, California. Design and build-out are underway, with production expected by the end of 2027, and the facility is designed to support oncology capacity of approximately 5,000 tests per day over time.

    鑑於我們的腫瘤檢測擴張速度之快,我們也在加州 Union City、緊鄰現有產前量產實驗室對面,簽署了一處專用的 62,000 平方英尺腫瘤量產實驗室租約。目前設計與建置正在進行中,預計於 2027 年底前投入生產;該設施的設計目標是隨時間推進可支援約每日 5,000 次的腫瘤檢測產能。

  • Looking at each product line, both prenatal and oncology contributed meaningfully to our growth. Prenatal revenue in the second quarter was $95.8 million, up 56% year-over-year, driven by strong commercial execution and rising ASPs. Oncology was even faster, with its revenue growing 176% year-over-year, nearly three times to $13.7 million, an annualized revenue run rate of approximately $55 million.

    從各產品線來看,產前與腫瘤兩者皆對我們的成長做出顯著貢獻。第二季產前營收為 9,580 萬美元,年增 56%,主要受惠於強勁的商業執行與 ASP 上升。腫瘤業務成長更快,營收年增 176%,接近三倍至 1,370 萬美元,年化營收運行率約為 5,500 萬美元。

  • Our total revenue performance in the quarter demonstrates the remarkable growth we have delivered in the last six years, rising from approximately 0 to $438 million in annualized run rate. Total revenue was $109.4 million in the quarter, representing 64% year-over-year growth, driven by strong year-over-year increases in both tests delivered, up 35%, and ASP, up 21%.

    本季的總營收表現展現了我們在過去六年所交付的顯著成長,年化運行率由約 0 成長至 4.38 億美元。本季總營收為 1.094 億美元,年增 64%,主要由檢測交付量年增 35% 與 ASP 年增 21% 共同帶動。

  • I would note that while reported revenue was only slightly up sequentially, that understates our underlying momentum. Excluding True-Up revenue, total revenue grew 8% sequentially quarter-over-quarter. The sustained level of growth continues to be an important part of our pillars.

    我想指出,雖然報告營收僅較前一季小幅增加,但這低估了我們的基本動能。若排除 True-Up(調整)營收,總營收季增 8%。持續的成長水準仍是我們支柱策略的重要一環。

  • Moving to our third pillar and starting with our ASPs. Overall ASP increased 21% year-over-year to $551 per test. ASP did decline about $20 sequentially. But this is simply a result of True-Up timing. True-Up was $49 per test in the first quarter versus $14 per test in the second quarter.

    接著談我們的第三支柱,先從 ASP 開始。整體 ASP 年增 21% 至每次檢測 551 美元。ASP 較前一季約下降 20 美元。但這僅是 True-Up 時點所致。第一季 True-Up 為每次檢測 49 美元,而第二季為每次檢測 14 美元。

  • Importantly, excluding the True-Up’s impact, ASPs increased $15 quarter-over-quarter. During the quarter, through a mutual agreement, we held more than $10 million of claims while waiting for the in-network implementation of our codes by national payers. This had a temporary impact on cash collections, slightly impacted the ASPs that we could realize, and potentially reduced the True-Up revenue for the quarter.

    重要的是,若排除 True-Up 的影響,ASP 季增 15 美元。本季在雙方協議下,我們在等待全國性保險支付方將我們的代碼納入網內(in-network)實施期間,暫緩提交超過 1,000 萬美元的理賠。這對現金回收造成暫時性影響,並略微影響我們可實現的 ASP,且可能降低本季的 True-Up 營收。

  • We expect this to resolve through the second half of the year as these claims are processed and paid. The more important underlying signal is this: excluding True-Up, overall ASP continued to increase sequentially, driven by a record number of payer contracts signed in the quarter.

    我們預期隨著這些理賠在下半年被處理並支付,該情況將獲得解決。更重要的基本訊號是:排除 True-Up 後,整體 ASP 仍持續季增,主要由本季簽署創紀錄數量的支付方合約所帶動。

  • In addition to driving ASP growth, we have remained committed to our operating philosophy of continuous improvements to reduce COGS per test. Overall COGS per test was $161 in the second quarter, up from $152 in the first quarter and $156 a year ago, with the increase driven by the shift in our volume mix towards oncology.

    除了推動 ASP 成長之外,我們也持續秉持營運理念,透過持續改善來降低每次檢測的 COGS。第二季每次檢測的整體 COGS 為 161 美元,高於第一季的 152 美元與去年同期的 156 美元;此一上升主要由於檢測量組合朝腫瘤業務移轉所致。

  • Underneath that mix effect, the operational discipline is very much intact. Prenatal COGS was approximately flat sequentially, even with the Unity Confirm launch, and we achieved COGS reductions of more than 10% quarter-over-quarter in oncology. As oncology continues to grow faster than prenatal, we expect overall COGS per test to rise gradually over time.

    在這種組合效應之下,我們的營運紀律依然非常到位。即使推出 Unity Confirm,產前(prenatal)COGS 連續季約略持平,而我們在腫瘤(oncology)方面也實現了超過 10% 的季對季 COGS 降幅。隨著腫瘤業務持續以快於產前的速度成長,我們預期整體每次檢測的 COGS 將隨時間逐步上升。

  • As a result, our gross margin held at 70.5% in the second quarter, approximately five percentage points higher year-over-year, driven by higher ASPs, even as our earlier-stage, lower-margin oncology tests grew more than 100% during this same period.

    因此,我們第二季毛利率維持在 70.5%,較去年同期高出約 5 個百分點,主要由較高的 ASP 所帶動;即便在同一期間,我們較早期、毛利率較低的腫瘤檢測成長超過 100%。

  • Importantly, small quarter-over-quarter differences in gross margin over the past four quarters are almost entirely attributable to quarterly true-up differences. Excluding true-up, our gross margin has been remarkably stable at around 70%, even with the significant mix shift towards oncology. By continuing to drive ASP increases across both prenatal and oncology, and by continuing to reduce COGS in oncology, we expect to maintain strong gross margins at or above 70%, even as oncology becomes a much bigger part of our overall business.

    重要的是,過去四個季度毛利率在季對季之間的小幅差異,幾乎完全可歸因於每季 true-up 調整差異。排除 true-up 影響後,我們的毛利率一直非常穩定,約在 70% 左右,即使產品組合明顯轉向腫瘤。透過持續推動產前與腫瘤兩條產品線的 ASP 提升,並持續降低腫瘤的 COGS,我們預期即使腫瘤在整體業務中的占比大幅提高,仍可維持 70% 或以上的強勁毛利率。

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

    接下來,我將把電話會議交給 Russ,在我做結語之前,請他回顧我們的財務結果與財測指引。

  • Ross Taylor - Chief Financial Officer

    Ross Taylor - Chief Financial Officer

  • Thank you, Ozan. Ozan mentioned, in Q2 of 2026, we had a strong performance that combined 64% year-over-year revenue growth with a 5% GAAP operating margin and a 15% adjusted EBITDA margin. Total revenue in the second quarter of 2026 was $109.4 million, compared to $66.6 million in the second quarter of 2025, representing an increase of 64%. Both our prenatal and oncology product lines demonstrated strong growth in the quarter.

    謝謝你,Ozan。如 Ozan 所提到,2026 年第二季我們表現強勁,營收年增 64%,同時達成 5% 的 GAAP 營業利益率與 15% 的調整後 EBITDA 利益率。2026 年第二季總營收為 1.094 億美元,較 2025 年第二季的 6,660 萬美元增加 64%。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 56% to $95.8 million in Q2. Oncology revenues increased 176% to $13.7 million in Q2 of 2026 versus Q2 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 year-over-year.

    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)在第二季成長 56% 至 9,580 萬美元。2026 年第二季腫瘤營收較去年同期成長 176% 至 1,370 萬美元。我們的總營收成長主要由產前與腫瘤兩者的檢測量成長所帶動,同時也受惠於產前與腫瘤 ASP 的年對年持續擴張。

  • True-up revenue was $2.8 million in the second quarter of 2026, compared to $9.2 million in the first quarter of 2026 and $2.1 million in the second quarter last year. Excluding true-up revenue, total revenue grew 8% sequentially versus the first quarter of 2026. Gross profit in the second quarter of 2026 was $77.1 million, compared to $43.5 million in the second quarter of 2025, resulting in a gross margin of 70.5% in the second quarter of 2026 versus 65.3% in the second quarter last year. The increase in gross margin was primarily attributable to continued increases in our overall ASP.

    2026 年第二季 true-up 營收為 280 萬美元,相較之下,2026 年第一季為 920 萬美元、去年第二季為 210 萬美元。排除 true-up 營收後,總營收較 2026 年第一季連續季成長 8%。2026 年第二季毛利為 7,710 萬美元,較 2025 年第二季的 4,350 萬美元增加,使 2026 年第二季毛利率為 70.5%,相較去年第二季的 65.3%。毛利率提升主要歸因於我們整體 ASP 的持續上升。

  • Total operating expenses were $71.6 million in the second quarter of 2026, compared to $45.1 million in the comparable prior year quarter, representing an increase of 59%. Within total operating expenses, R&D expense was $17.3 million in the second quarter of 2026, compared to $11.8 million in the comparable prior year quarter.

    2026 年第二季總營業費用為 7,160 萬美元,較去年同期的 4,510 萬美元增加 59%。在總營業費用中,2026 年第二季研發費用為 1,730 萬美元,較去年同期的 1,180 萬美元增加。

  • SG&A expense was $54.3 million in the second quarter of 2026, compared to $33.3 million in the comparable prior year quarter. Operating income was $5.5 million in the second quarter of 2026, compared to an operating loss of $1.6 million in the second quarter of 2025.

    2026 年第二季 SG&A 費用為 5,430 萬美元,較去年同期的 3,330 萬美元增加。2026 年第二季營業利益為 550 萬美元,相較之下,2025 年第二季為營業損失 160 萬美元。

  • Our Q2 operating profit margin was 5%, compared to the 16% operating margin we delivered in the first quarter of 2026. Slightly over half of the difference in operating profit compared to Q1 was due to the difference in true-up revenue between the two quarters. The remaining portion was driven by continued investment in our commercial and R&D organizations, as well as faster growth in oncology.

    我們第二季營業利益率為 5%,相較於 2026 年第一季達成的 16% 營業利益率。與第一季相比,營業利益差異中略高於一半是由兩季 true-up 營收差異所致。其餘部分則來自我們對商業與研發組織的持續投資,以及腫瘤業務更快的成長。

  • Adjusted EBITDA in Q2 represented a 15% margin. Net income available to common shareholders was $8.1 million, or $0.15 per diluted share in the second quarter of 2026, compared to a net loss of $0.2 million for the same period in 2025.

    第二季調整後 EBITDA 利益率為 15%。2026 年第二季歸屬於普通股股東的淨利為 810 萬美元,或稀釋後每股 0.15 美元;相較之下,2025 年同期淨損為 20 萬美元。

  • Looking at the cash flow statement for the second quarter, the cash flow from operations was $9.1 million, while capital expenditures were $4.0 million. This resulted in free cash flow of $5.1 million in the second quarter of 2026.

    從第二季現金流量表來看,營運活動現金流為 910 萬美元,而資本支出為 400 萬美元。因此,2026 年第二季自由現金流為 510 萬美元。

  • We are well capitalized with a very healthy balance sheet. We ended the second quarter with $549 million in cash and equivalents. 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.

    我們資本結構充足,資產負債表非常健康。第二季結束時,我們持有 5.49 億美元的現金及約當現金。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為目標來管理業務。

  • Finally, I will provide an update on our full year guidance for 2026. We are reiterating our 2026 total revenue outlook of $450 million to $465 million, representing growth of approximately 48% to 52% compared to full year 2025. We also expect to operate the business such that it will continue to generate profitability similar to current levels, even with significant continued investments.

    最後,我將更新我們 2026 年全年的財測指引。我們重申 2026 年總營收展望為 4.50 億至 4.65 億美元,較 2025 年全年成長約 48% 至 52%。我們也預期在持續進行重大投資的同時,仍將以使公司持續產生與目前水準相近的獲利能力來營運。

  • I will now turn the call back to Ozan to conclude.

    我現在把電話會議交回給 Ozan 做結語。

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

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

  • Thank you, Ross. In summary, we are transforming healthcare one molecule at a time, one patient at a time. My confidence, as always, is rooted not in any single element, but in the compounding nature of what we have built. Each product we launch makes our platform more powerful, from Unity Confirm to our expanded fetal risk screen to Northstar Origin, and each study we publish further validates the clinical utility of our technology as our Northstar Response publication did this quarter.

    謝謝你,Ross。總結來說,我們正以「一次一個分子、一次一位病患」的方式改變醫療照護。一如既往,我的信心並非建立在任何單一要素上,而是建立在我們所打造的一切所產生的複利效應。我們推出的每一項產品都讓平台更強大,從 Unity Confirm、到我們擴增的胎兒風險篩檢、再到 Northstar Origin;而我們發表的每一項研究也進一步驗證我們技術的臨床效用,就像本季發表的 Northstar Response 論文一樣。

  • Our financial profile remains best in class for our industry. Once again, this quarter, we demonstrated strong revenue growth to $438 million in annualized run rate. We held gross margins above 70%, and we show that rapid growth does not have to come at the expense of profitability.

    我們的財務體質在本產業中仍屬同級最佳。本季我們再次展現強勁營收成長,年化 run rate 達到 4.38 億美元。我們將毛利率維持在 70% 以上,並證明快速成長不必以犧牲獲利能力為代價。

  • 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. Our ambition remains clear: to transform molecular diagnostics, build a category-defining company, and earn a place in the S&P 500. We are pleased with our progress and look forward to updating you as the year progresses.

    推動我們前進的是一支高度投入、以使命為導向的團隊;他們每天帶著共同目標出現,為病患的生活帶來有意義的改變。我們的企圖心依然清晰:改造分子診斷、打造一家具類別定義性的公司,並在標普 500 指數中占有一席之地。我們對目前的進展感到滿意,並期待在今年接下來的時間持續向各位更新。

  • Thank you. Over to the operator.

    謝謝。交給接線員。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Mark Massaro, BTIG.

    Mark Massaro,BTIG。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Hey, guys. Thank you for taking the questions. Maybe the first one, obviously it looks like the true-up number dropped by approximately $6 million or so in Q2 relative to Q1. I guess, Ozan and Ross, I just wanted to check if, ex true-ups, just double-checking that your prenatal test revenue would’ve increased sequentially. Is that correct?

    嗨,各位。謝謝你們回答問題。第一個問題是,很明顯第二季相較第一季 true-up 數字大約下降了 600 萬美元左右。我想,Ozan 和 Ross,我只是想確認一下:若排除 true-up,產前檢測營收應該是連續季增加的,對嗎?是這樣嗎?

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

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

  • That is correct, Mark. Both test volumes and ASPs for prenatal ex true-up actually increased, so the combination increased significantly as well. Ross, do you want to comment on the actual numbers?

    沒錯,Mark。產前(排除 True-Up)不僅檢測量與 ASP(平均售價)都實際上增加,因此兩者結合後的增幅也相當顯著。Ross,你要不要評論一下實際數字?

  • Ross Taylor - Chief Financial Officer

    Ross Taylor - Chief Financial Officer

  • For the actuals.

    就實際數字而言。

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

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

  • On the prenatal revenue.

    關於產前營收。

  • Ross Taylor - Chief Financial Officer

    Ross Taylor - Chief Financial Officer

  • Yeah, prenatal revenue, honestly, Mark, you can assume that virtually all of the True-Up is related to prenatal. We do have a chart, I think it’s slide 14 in the deck, where I think you can make some pretty good estimates as to where the prenatal revenue is ex True-Up. Sorry, I don’t have the actual numbers right in front of me, and we haven’t given out those specifics in the past, but it is up more than a couple million dollars sequentially ex True-Up.

    對,產前營收,老實說,Mark,你可以假設幾乎所有的 True-Up 都與產前相關。我們確實有一張圖,我想是在簡報第 14 頁,你可以相當合理地估算排除 True-Up 的產前營收大概在哪裡。抱歉,我手邊沒有實際數字,而且我們過去也沒有對外提供那些細項,但排除 True-Up 後,按季增加超過幾百萬美元。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • Yeah. And then I do understand you guys operate in a competitive market. There are many other players operating in the space. I know you’ve been taking share for years now. I guess, can you just speak to what you might be seeing in the competitive market?

    好的。然後我也理解你們是在競爭激烈的市場中營運。這個領域有很多其他參與者。我知道你們多年來一直在取得市占。我想問的是,你們在競爭市場上看到什麼情況?

  • And then related to that, my last question, you did accelerate hiring of sales reps, it sounds like, relative to your plan. Just curious if any of those stepped-up hires might have something to do with the competitive environment.

    另外相關的最後一個問題,你們似乎相較於原先計畫加速招募業務代表。想請教這些加速招募是否與競爭環境有關。

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

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

  • So second quarter volumes were almost entirely as we expected in the quarter, Mark. We did grow as much as we expected in prenatal and slightly above expectations in oncology with respect to test volume. We weren’t doing the hiring due to the competitive environment, but actually due to continued opportunity that we have, especially with respect to health systems. We are managing the business for more medium to long-term growth.

    Mark,第二季的量幾乎完全符合我們對該季的預期。就檢測量而言,我們在產前的成長符合預期,在腫瘤方面則略高於預期。我們並不是因為競爭環境而招募,而是因為我們持續看到機會,特別是在醫療體系(health systems)方面。我們是在以中長期成長來管理這門業務。

  • And there are maybe about four factors that we believe that will come together in the next two to four quarters that will really derive significant growth in prenatal. The hiring of sales reps is one, but of course, that takes time for them to be onboarded and be productive and start penetrating health systems. Just as we onboard these sales reps, Unity Confirm is opening up doors to new health systems. And we believe that will be further accelerated with more data readouts that we’ll have in the next two to three quarters.

    我們認為接下來兩到四季大概有四個因素會匯聚,真正帶動產前的顯著成長。招募業務代表是其中之一,但當然需要時間讓他們到職、完成訓練、提升產能並開始打入醫療體系。就在我們讓這些業務代表到職的同時,Unity Confirm 也正在為我們打開新的醫療體系大門。而我們相信,隨著未來兩到三季會有更多數據讀出(data readouts),這個趨勢會進一步加速。

  • Third, we completed the onboarding to Epic Aura platform faster than any other lab. And that will take two to four quarters to see a significant impact. We are executing extremely well there. And finally, I want to really underline the importance of the 130 gene Fetal Risk Screen launch. This is going to be a significant competitive advantage, but it will make an even bigger impact in health systems where they want a portfolio of offerings, including these large panels.

    第三,我們完成 Epic Aura 平台的導入上線速度比任何其他實驗室都快。而要看到顯著影響大概需要兩到四季。我們在那方面執行得非常好。最後,我想特別強調 130 基因 Fetal Risk Screen 的上市重要性。這將成為顯著的競爭優勢,但在醫療體系中影響會更大,因為他們希望有一整套產品組合,包括這些大型 panel。

  • So we really believe that these four factors are going to come together in the next two to four quarters to create really an engine of health system adoption that can derive substantial volume growth. What we are really doing in the first half of the year is to, with the hiring pipeline that we have been able to generate, post going public, we have accelerated hiring so that all of these reps are joining and getting onboarded at the right time, so that as all of these opportunities are coming together, we have a really strong chance of converting these test volumes from health systems.

    因此我們真的相信,這四個因素會在接下來兩到四季匯聚,形成一個推動醫療體系採用的引擎,進而帶來可觀的檢測量成長。我們在上半年真正做的是:在我們上市後能建立起的招募管道支持下,我們加速招募,讓這些業務代表在正確的時間點加入並完成到職導入,這樣當所有機會同時到來時,我們就有很強的機會把醫療體系的檢測量轉化為實際量。

  • Ross Taylor - Chief Financial Officer

    Ross Taylor - Chief Financial Officer

  • Maybe just a quick follow-up, Mark. I did look up some of the numbers to try to answer the earlier part of your question. I’m not going to get overly specific, but I think quarter to quarter, we did see about a $4.5 million increase in prenatal revenues. If you exclude the true-up, it’s about 5% growth sequentially. Just to get a little more specific.

    Mark,我補充追問一下。我剛剛查了一些數字,想回答你前面問題的那一部分。我不會講得太細,但我認為按季來看,我們的產前營收大約增加了 450 萬美元。如果排除 true-up,按季約成長 5%。提供你更具體一點的資訊。

  • Mark Massaro - Equity Analyst

    Mark Massaro - Equity Analyst

  • That’s really helpful. Alright. Thanks, guys.

    這真的很有幫助。好。謝謝各位。

  • Operator

    Operator

  • Dan Arias, Stifel.

    Dan Arias,Stifel。

  • Daniel Arias - Analyst

    Daniel Arias - Analyst

  • Hi, guys. Thanks for the questions. Oguzhan, I think you alluded a little bit to the volume trend there. Can you maybe just add some additional color to the trend sequentially in oncology if you strip out the ASP dynamic? To what degree was quarterly volume up as a trajectory? Then how should we think about things for the second half of the year relative to the way that maybe you were thinking about things earlier in the year?

    嗨,各位。謝謝讓我提問。Oguzhan,我想你稍微提到了一點那邊的量的趨勢。如果把 ASP 的變動因素拿掉,你能否再補充一些腫瘤業務按季趨勢的細節?就軌跡而言,季度量上升的幅度到什麼程度?另外,相較於你們年初可能的看法,我們應該如何看待下半年?

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

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

  • So ASPs for oncology actually did not change in quarter-over-quarter. We are waiting and working on the MolDX coverage of Response. Until that happens, ASPs are pretty stable in oncology. And if you look at the chart that Ross referred to, True-Up for oncology was both quarters was almost very minimal as well. So all of the growth that you are seeing sequentially is coming from the test volume growth in oncology. Oncology test volumes are doing really well, even ahead of our expectations.

    腫瘤的 ASP 其實按季並沒有變化。我們正在等待並推進 Response 的 MolDX 覆蓋(coverage)。在那之前,腫瘤的 ASP 相當穩定。而如果你看 Ross 提到的那張圖,腫瘤的 True-Up 兩季都幾乎非常少。所以你看到的所有按季成長都來自腫瘤檢測量的成長。腫瘤檢測量表現非常好,甚至超出我們的預期。

  • And that is one of the reasons that we have started to build this oncology lab to I think we are seeing that we are winning in the market with the products that we have, and as we are adding more competitive components to our oncology products, we are very confident on the trajectory.

    這也是我們開始建立這個腫瘤實驗室的原因之一;我認為我們看到自己憑藉現有產品正在市場上勝出,而隨著我們在腫瘤產品中加入更多具競爭力的要素,我們對這個成長軌跡非常有信心。

  • Daniel Arias - Analyst

    Daniel Arias - Analyst

  • Do you think that trajectory will lead to sequentially up volumes each quarter? I mean, in 4Q can be a little bit of a funky quarter, but you do sound like you have good momentum. Not to put too fine of a point on it, but I’m just curious whether 2Q to 3Q can be up and then 3Q to 4Q can be up as well so that we model this thing correctly. Thank you.

    你認為這個軌跡會帶來每一季都按季成長的量嗎?我的意思是,第 4 季有時會有點不太規則,但聽起來你們動能不錯。不是要把問題問得太尖銳,但我只是想確認:2Q 到 3Q 會成長,然後 3Q 到 4Q 也會成長嗎?這樣我們才能把模型建得正確。謝謝。

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

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

  • Yeah. I think 2Q to 3Q, we certainly see very strong momentum. As you mentioned, 3Q to 4Q tends to be a little bit of a, in terms of number of providers that we add, it tends to be a strong quarter, but in terms of the number of accessioning days and how the test volumes and revenues translate, it tends to be a little bit of a shorter quarter. We are seeing that our oncology is progressing ahead of the plan.

    是的。我認為從 2Q 到 3Q,我們確實看到非常強的動能。如你所說,3Q 到 4Q 往往有點不同:就新增的提供者(providers)數量而言,通常是強勁的一季;但就收案(accessioning)天數以及檢測量與營收如何轉換而言,通常會是一個比較短的季度。我們看到腫瘤業務的進展超前於計畫。

  • Daniel Arias - Analyst

    Daniel Arias - Analyst

  • Okay. Thank you.

    好的。謝謝。

  • Operator

    Operator

  • Subbu Nambi, Guggenheim.

    Subbu Nambi,Guggenheim。

  • Unidentified Participant

    Unidentified Participant

  • Hi, this is Ricky on for Subbu. Thanks for taking our questions. You gave some color on the Unity Confirm launch and adoption and the 50% opt-in for the eligible results. While it’s still early in the launch, do you think that’s already starting to drive share gains in NIPT?

    嗨,我是 Ricky,代 Subbu 提問。謝謝讓我們提問。你們分享了一些 Unity Confirm 上市與採用情況的細節,以及符合條件結果有 50% 選擇加入(opt-in)。雖然上市還早,你認為這是否已經開始推動 NIPT 的市占提升?

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

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

  • I think it is certainly opening up doors, and it is reducing the tendency for at least some accounts to split. I think it is rare for prenatal clinics to split their test volumes over multiple labs, Unity Confirm does prevent that splitting, I think, more significantly. But I think it is going to be a long-term driver rather than a much shorter-term driver, particularly because a lot of the remaining opportunities help systems, and they don’t get onboarded within one or two months.

    我認為這確實正在打開大門,並且正在降低至少部分帳戶分拆的傾向。我認為產前診所很少會把其檢測量分散到多家實驗室,Unity Confirm 的確能更顯著地防止這種分拆。但我認為它將會是長期的成長驅動因素,而不是較短期的驅動因素,特別是因為許多剩餘的機會在醫療體系端,而它們不會在一到兩個月內完成導入。

  • Unity Confirm launched in May 28, and it is already seeing strong adoption, and so it’s already getting us through the door in these health systems. These health systems require many other things like EMR before they can switch to another lab. This is why we are really confident that all of these factors are coming in together to drive an acceleration of growth, especially as we look to growth next year.

    Unity Confirm 於 5 月 28 日推出,且已經看到強勁的採用,因此它已經幫助我們打入這些醫療體系。這些醫療體系在能切換到另一家實驗室之前,還需要許多其他條件,例如 EMR。這也是為什麼我們非常有信心,所有這些因素正在共同作用以推動成長加速,尤其是當我們展望明年的成長時。

  • Unidentified Participant

    Unidentified Participant

  • Got it. That’s helpful. And you also announced the expanded 130 gene risk screen panel. Just wondering if there’s any change to how you’re thinking about the economics per test there, either in terms of reimbursement or the COGS. Thanks.

    了解。這很有幫助。你們也宣布擴大到 130 基因的風險篩檢面板。想請教你們對於每次檢測的經濟性是否有任何想法上的改變,不論是在給付(reimbursement)或銷貨成本(COGS)方面。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 do not expect much of a difference in the economics with respect to 130 gene panel. It’s not going to be immediately a large portion of our test volume either, but I think it is going to enable us to get into some of these health systems and other places that strongly prefer existence of a large panel. And because this is the only large panel with the cell-free DNA offering, I think it is going to be a big competitive advantage for us.

    我們預期 130 基因面板在經濟性方面不會有太大差異。它也不會立刻成為我們檢測量中的很大一部分,但我認為它將使我們能進入一些醫療體系及其他非常偏好大型面板存在的場域。而且因為這是唯一結合無細胞 DNA(cell-free DNA)方案的大型面板,我認為這將成為我們的一大競爭優勢。

  • Operator

    Operator

  • Tycho Peterson, Jefferies.

    Tycho Peterson,Jefferies。

  • Unidentified Participant

    Unidentified Participant

  • Hi, this is Noah Kavan for Tycho. Thanks for taking our questions. Wanted to ask on the Northstar Origin announcement today. What percentage of your patient base do you think is relevant for potential attach here? And how are you assuming that the economics pan out here over the next couple of quarters?

    你好,我是代 Tycho 提問的 Noah Kavan。謝謝你們回答我們的問題。想問一下今天關於 Northstar Origin 的公告。你們認為你們的病患基礎中,有多少比例與這裡潛在的附加(attach)相關?以及你們如何假設未來幾個季度這裡的經濟性會如何展開?

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

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

  • Northstar Origin will not necessarily change the economics of the product that much. It is going to, I think, derive incremental adoption of our products. In particular, this has been an increasingly important point of discussion with providers that we are seeing. So it is, I think, it is becoming very important, especially in community oncology settings, where the percentage of cases is not 3%.

    Northstar Origin 不一定會大幅改變該產品的經濟性。我認為它將帶來我們產品的增量採用。特別是,這已成為我們與醫療提供者討論中越來越重要的一點。因此我認為它正變得非常重要,尤其是在社區腫瘤(community oncology)場景中,那裡的病例比例並不只有 3%。

  • So CUP cases, the truly unknown primary case is about 3%. And that can be an important reason for some of the oncologists to prefer one platform over others. But we are also seeing that in the community oncology settings, this problem is more than a 3% problem, especially as they do not have access to all these pathology workups.

    所以,CUP 病例,也就是真正原發灶不明的病例,大約是 3%。而這可能是一些腫瘤科醫師偏好某一平台而非其他平台的重要原因。但我們也看到,在社區腫瘤場景中,這個問題不只是 3% 的問題,特別是因為他們無法取得所有這些病理檢查(pathology workups)。

  • And there, one in 10 patients might actually have an uncertain diagnosis. And that really makes the next steps very difficult for these patients. So I don’t think it will change the economics, but it will be another driver of adoption, similar to what we have seen so far with our [ChIP-sequencing] as well as the PGx offerings that we launched in the first quarter.

    在那裡,可能每 10 位病患就有 1 位實際上有不確定的診斷。而這會讓這些病患的後續步驟變得非常困難。所以我不認為它會改變經濟性,但它會成為另一個採用的驅動因素,類似於我們迄今在 [ChIP-sequencing] 以及我們在第一季推出的 PGx 產品上所看到的情況。

  • Unidentified Participant

    Unidentified Participant

  • Thanks. For my follow-up here, one of your competitors noted incremental payer friction in prenatal testing, more so on the carrier screening side of things. Curious if there’s anything you can comment on there, if you’re seeing any friction there.

    謝謝。我接著想問,你們的一位競爭對手提到在產前檢測方面,付款方(payer)的摩擦增加,尤其是在帶因篩檢(carrier screening)那一側。想了解你們是否能評論一下,你們是否也看到任何摩擦。

  • 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 friction there, but that is also because we have been -- I think, very intentional about how we went about coding in this particular field. We bill almost vast majority of our tests using the PLA codes that we have obtained, rather than relying on some of the bundled or stacked billing that tends to be more common.

    我們沒有看到任何摩擦,但這也因為我們在這個領域的編碼方式上——我認為——非常有意識、很有策略。我們幾乎絕大多數的檢測都是使用我們取得的 PLA 代碼來請款,而不是依賴較常見的打包(bundled)或堆疊(stacked)式請款。

  • And this is something that we have observed, especially with some of the national payers requiring these panels not to be unbundled and billed with separate codes. But we were able to get our PLA code effective January 2025. So we do not have the problem that I think some of the other prenatal testing companies might have with respect to friction.

    而這是我們觀察到的情況,特別是一些全國性付款方要求這些面板不得拆包(unbundled),並以不同代碼分開請款。但我們已能讓我們的 PLA 代碼自 2025 年 1 月起生效。因此在摩擦方面,我們沒有我認為某些其他產前檢測公司可能會遇到的問題。

  • Unidentified Participant

    Unidentified Participant

  • Thank you.

    謝謝你。

  • Operator

    Operator

  • David Westenberg, Piper Sandler.

    David Westenberg,Piper Sandler。

  • David Westenberg - Analyst

    David Westenberg - Analyst

  • Hi. Thank you for taking my question. So I wanted to ask on, if you look year-over-year, you actually on slide 14, and thanks, that’s a lot of data. I think Ross mentioned $4.5 million sequentially revenue. It looked year-over-year, it looks like the same. I’m just kind of curious. I know Natera reports seasonality in Q2. I know traditionally you guys have said you haven’t seen it, but you were a lot smaller percentage of the market. So do you think you might have additional seasonality in Q2 in non-prenatal testing and that maybe it would follow the same exact trends where you’d see Q3 and Q4 potentially doing better?

    你好。謝謝你回答我的問題。我想問的是,如果你看年對年,你們在第 14 頁投影片上——謝謝,那裡有很多數據。我想 Ross 提到序列(sequential)營收增加 450 萬美元。但看年對年似乎是一樣的。我只是有點好奇。我知道 Natera 會在第二季報告季節性。我知道你們傳統上一直說沒有看到,但當時你們在市場中的占比小得多。所以你們是否認為在第二季的非產前檢測也可能有額外的季節性,並且可能會遵循相同的趨勢,也就是第三季和第四季可能表現更好?

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

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

  • Certainly, there are fewer patients that are getting tested in the accounts that we already have. So there is, I think, certainly a small impact with respect to seasonality. We do not model that seasonality, and we were able to be ahead of our plan even with that seasonality. And we didn’t want to refer to seasonality in a quarter where we were able to be at or ahead of what we had modeled without the seasonality.

    確實,在我們既有的帳戶中,接受檢測的病患數較少。因此我認為季節性確實會帶來一些小幅影響。我們並未在模型中納入該季節性,而即便有這個季節性,我們仍能超前我們的計畫。而且我們不想在一個季度中提及季節性,因為在那個季度裡,即使未將季節性納入模型,我們仍能達到或超過我們所建模的水準。

  • But it is certainly true. If you look at the number of pregnancies and births or even the number of tests that you get from accounts that you know you are getting 100% of the test volume, there is a drop in Q2 in terms of the test volume. So that seasonality, I think, is real.

    但這確實是真的。如果你看懷孕與出生的數量,甚至是你從那些你知道你拿到 100% 檢測量的帳戶所取得的檢測數,在第二季檢測量會下降。所以我認為那個季節性是真實存在的。

  • I think the effect tends to be relatively small, but I think as you pointed out, as we get larger, there is certainly the seasonality can have a bigger impact. We didn’t want to refer to it because we didn’t model it that way.

    我認為其影響通常相對較小,但如你所指出的,隨著我們規模變大,季節性確實可能帶來更大的影響。我們不想提及它,因為我們並不是用那種方式來建模。

  • David Westenberg - Analyst

    David Westenberg - Analyst

  • Got it. Okay. I just want to talk about the disclosed claims of $10 million, I think, pending in Q2 network by national payers that you suppressed up to your true-ups. Can you help us bridge this? Once those specific claims are processed, how does that $10 million flow through? I just want to make sure, clarification, I think it’s always been the case, but you are not modeling true-ups in the back half with your guidance, correct? I think that’s been how you’ve always done it, but just want to confirm. Thank you. Thank you guys so much.

    了解。好。我想談談你們披露的 1,000 萬美元理賠(claims),我想是在第二季由全國性付款方的網內(in-network)理賠仍在處理中,而你們在調整(true-ups)之前先行抑制(suppressed)了。你能幫我們把這部分串起來嗎?一旦那些特定理賠被處理完成,那 1,000 萬美元會如何反映(flow through)?我想確認一下,我認為一直都是如此,但你們在指引(guidance)中並沒有在下半年納入 true-ups 的建模,對嗎?我想這一直是你們的做法,但想確認一下。謝謝。也非常感謝各位。

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

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

  • Ross, do you want to take the true-up question, and then I’ll take the $10 million question?

    Ross,你想先回答 true-up 的問題嗎?然後我來回答那個 1,000 萬美元的問題?

  • Ross Taylor - Chief Financial Officer

    Ross Taylor - Chief Financial Officer

  • Sure. Yeah, that’s correct regarding the true-ups and our guidance. David, we really are not including any true-ups in our kind of forward-looking guidance here beyond what we’ve already reported.

    當然。是的,關於 true-up 以及我們的指引,你的理解是正確的。David,我們在這裡所提供的前瞻性指引中,除了我們已經揭露/報告過的內容之外,確實沒有納入任何 true-up。

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

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

  • And with respect to the $10 million of health claims, while a portion of it is embedded in realized revenue, as we are required under ASC 606, we have been very conservative in how we approach this, and so there is meaningful upside if all these back claims process and pay. We want to be conservative here. We don’t yet know the full timing or amount of what will ultimately be collected on the claims held. So that is why we are maintaining guidance until that is clearer.

    至於那 1,000 萬美元的健康理賠,雖然其中一部分依照 ASC 606 的要求已內含在已實現收入中,但我們在處理這件事時採取了非常保守的做法,因此如果這些追溯理賠都完成處理並支付,仍有相當可觀的上行空間。我們希望在這裡保持保守。我們目前仍不清楚最終可收回的理賠款項在時間點或金額上的全貌。因此,在情況更明朗之前,我們會維持既有指引。

  • Operator

    Operator

  • Casey Woodring, J.P. Morgan. .

    Casey Woodring,摩根大通(J.P. Morgan)。.

  • Casey Woodring - Analyst

    Casey Woodring - Analyst

  • Great. Thank you for taking my questions. Maybe just one. You talked a lot about launching on Epic Aura in the quarter and that you’ve integrated faster than any other lab. Is there a scenario where you can be fully integrated by the time we enter 2027? And you talked about a meaningful impact next year. Maybe any way to quantify what the impact would look like from full integration in your base case?

    很好。謝謝你們回答我的問題。也許就一個。你們談到本季在 Epic Aura 上線很多內容,並且你們的整合速度比任何其他實驗室都快。是否有可能在我們進入 2027 年之前就能完全整合?你們也提到明年會有顯著影響。在你們的基本情境下,能否量化一下完全整合後的影響大概會是什麼樣子?

  • 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. We are fully integrated with Epic Aura. The issue is that even after the full integration with Epic Aura, there is still work that each health system needs to do to turn on their Epic Aura and make sure that everything goes back and forth correctly with respect to orders and test results.

    謝謝你,Casey。我們已經與 Epic Aura 完全整合。問題在於,即使完成與 Epic Aura 的完整整合之後,每個醫療體系仍需要做一些工作,去啟用他們的 Epic Aura,並確保在醫囑與檢測結果的往返傳輸上,一切都能正確運作。

  • Typically, a time that the lab takes to integrate with each health system separately, like uniquely, still tends to be with many labs, six months or more. This is what we heard in the field. Our integrations have been lightning fast in comparison.

    通常,實驗室要與每個醫療體系分別、也就是以各自獨特的方式完成整合,對許多實驗室而言仍往往需要六個月或更久。這是我們在市場一線聽到的。相較之下,我們的整合速度快得驚人。

  • Our first integrations have been two to four weeks, which is a record time even for these individual health system integrations. So we are using that to try to get these health systems to prioritize our integrations and slot the kind of individual integration into their roadmap.

    我們最初的整合只花了兩到四週,這即使就這些單一醫療體系的整合而言,也是創紀錄的時間。因此我們利用這點,嘗試讓這些醫療體系優先處理與我們的整合,並把這類個別整合排進他們的路線圖。

  • But it can still be two to four quarters ahead. As soon as we are green-lighted, we can do these integrations extremely fast. Once they are done, I think we see meaningful test volume growth. Just to give you a sense, once a health system is onboarded, each one can be anywhere between 1 to 3,000 tests per quarter.

    但即便如此,仍可能要提前兩到四個季度。一旦我們獲得綠燈,我們就能非常快速地完成這些整合。完成之後,我認為我們會看到顯著的檢測量成長。給你一個概念:一旦某個醫療體系完成導入,每一家每季的檢測量可能介於 1 到 3,000 次。

  • The issue tends to be, this tends to be a funnel, and the funnel really started as of May or June. As we are getting into their roadmaps, I think it is going to be slow initially, and it will accelerate over time pretty significantly. In terms of how much test volume that it is going to incrementally bring, that is very difficult to say because, again, it is not about our own teams and what they can do. It is how many health systems that we can convince to put our individual integration into their roadmap.

    問題通常在於,這是一個漏斗,而這個漏斗大概從 5 月或 6 月才真正開始。當我們逐步進入他們的路線圖後,我認為一開始會比較慢,但隨著時間推進會相當明顯地加速。至於會帶來多少增量檢測量,這很難說,因為再一次,這不在於我們自己的團隊能做什麼。而在於我們能說服多少醫療體系把與我們的個別整合排進他們的路線圖。

  • Casey Woodring - Analyst

    Casey Woodring - Analyst

  • I see. That’s helpful. And then maybe just one on the gross margin profile. You did 70.5% here. How should we think about that progression once Northstar Response is reimbursed? Kind of like what’s the forward-looking trajectory there once you’re able to turn that on? Thank you.

    了解。這很有幫助。另外也許再問一個關於毛利率結構的問題。你們這次做到 70.5%。一旦 Northstar Response 開始獲得給付/報銷,我們應該如何看待毛利率的走勢?也就是說,一旦你們能把那部分打開之後,前瞻性的軌跡會是怎樣?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. That’s a good question. One way to think about this is that we are really managing the business for balancing that growth and with gross margin and profitability. Even when Northstar Response comes in with the MolDX coverage, we will be launching MRD at that time, and we are not going to be throttling the MRD test volume.

    謝謝。這是個好問題。一種思考方式是:我們其實是在管理這門生意時,同時平衡成長、毛利率與獲利能力。即使 Northstar Response 在 MolDX 覆蓋下開始導入,我們也會在那個時間點推出 MRD,而我們不會去限制(throttle)MRD 的檢測量。

  • So what that will mean is that, as the Northstar Response ASPs goes up and as our oncology gross margins increase, we will have dilutive gross margins that will be coming from that growth that we will see from MRD. So the way that we are thinking about this is that if the business operates as planned and modeled, we expect to maintain 70% gross margin, regardless of the mix or growth of oncology or lumpiness of the True-Up revenue.

    因此這代表,隨著 Northstar Response 的 ASP(平均售價)上升、以及我們腫瘤業務的毛利率提高,我們也會因 MRD 帶來的成長而出現稀釋毛利率的影響。所以我們的想法是:如果業務如計畫與模型所預期地運作,我們預期可維持 70% 的毛利率,不論腫瘤業務的組合或成長,或 True-Up 收入的波動性如何。

  • This is what we have seen in the last four quarters, where the gross margin was 70% without True-Up every quarter despite the really fast growth that we had in oncology. So I think we will continue to see that and we will continue to -- I think, manage the business to be above 70% gross margins by increasing ASPs in different product lines and reducing COGS, especially in oncology.

    這也是我們在過去四個季度看到的情況:即使腫瘤業務成長非常快,在每一季都沒有 True-Up 的情況下,毛利率仍是 70%。因此我認為我們會持續看到這樣的表現,而且我們也會持續——我想——透過在不同產品線提高 ASP、並降低 COGS(銷貨成本),特別是在腫瘤領域,來管理業務,使毛利率維持在 70% 以上。

  • That said, an unexpected acceleration in oncology business far beyond what we are modeling could even result in gross margins to be temporarily below 70%. The important thing here is that every product is designed to generate 70% to 80% gross margin in the long term with scale and appropriate coverage.

    話雖如此,若腫瘤業務出現超出我們模型預期的意外加速,甚至可能導致毛利率在短期內暫時低於 70%。重點在於:每一項產品在長期、隨著規模擴大並取得適當的給付覆蓋後,都是以產生 70% 到 80% 毛利率為設計目標。

  • It is just that, as some of our products that are more mature that get closer to 80% gross margin, we are building and launching new products that become dilutive to gross margin. The balance becomes something in the range of 70% gross margin.

    只是,當我們某些較成熟的產品毛利率逐步接近 80% 時,我們也在開發並推出新產品,而新產品會對毛利率造成稀釋。兩者平衡後,結果大致會落在 70% 左右的毛利率區間。

  • Casey Woodring - Analyst

    Casey Woodring - Analyst

  • Understood. Thank you.

    了解。謝謝。

  • Operator

    Operator

  • And I’m not showing any further questions at this time. And as such, this does conclude today’s presentation. Thank you for your participation. You may now disconnect and have a wonderful day.

    目前我這邊沒有看到其他問題。因此,今天的簡報到此結束。感謝各位的參與。各位現在可以斷線,祝各位有美好的一天。