使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Thank you for standing by, and welcome to BillionToOne's fourth quarter and full-year 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. (Operator Instructions)
感謝您的耐心等待,歡迎參加 BillionToOne 2025 年第四季及全年業績電話會議。目前,所有參與者均處於唯讀模式。演講結束後,將進行問答環節。(操作說明)
I would now like to hand the call over to [David Dyckler], Investor Relations. Please, go ahead.
現在我將把電話交給投資者關係部的 [David Dyckler]。請繼續。
David Dyckler - Investor Relations
David Dyckler - Investor Relations
Good afternoon, everyone. Thank you for participating in today's conference call. Joining me on the call from BillionToOne, have Oguzhan Atay, Co-Founder and Chief Executive Officer; and Ross Taylor, Chief Financial Officer. Earlier today, BillionToOne released financial results for the fourth quarter and full year ended December 31, 2025. A copy of the press release is available on the company's website.
大家下午好。感謝您參加今天的電話會議。與我一同參加此次電話會議的還有來自 BillionToOne 的聯合創始人兼執行長 Oguzhan Atay 和財務長 Ross Taylor。今天早些時候,BillionToOne 發布了截至 2025 年 12 月 31 日的第四季和全年財務表現。新聞稿副本可在公司網站上查閱。
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. 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.
在開始之前,我想提醒各位,在本次電話會議中,我們可能會做出符合聯邦證券法定義的前瞻性陳述。此類關於未來事件的聲明可能包括關於我們的財務前景和業績、市場規模、我們的產品和服務、報銷範圍、未來臨床表現以及其他類似聲明。我們提醒您,此類聲明反映了我們目前的最佳判斷,實際結果可能與任何前瞻性聲明中明示或暗示的結果有重大差異。
Risk factors that may cause our results to differ are discussed in our filings with the SEC, including our previously filed registration statement on Form-S1, our previously filed quarterly report on Form 10-Q, are in a report on Form 10-K to be filed following this call, and the current report on Form 8-K filed today. Any forward-looking statement made during this call is made as of today, March 4, 2026.
可能導致我們業績出現差異的風險因素已在提交給美國證券交易委員會的文件中進行了討論,包括我們之前提交的 S1 表格註冊聲明、之前提交的 10-Q 表格季度報告、將在本次電話會議後提交的 10-K 表格報告以及今天提交的 8-K 表格當前報告。本次電話會議中所作出的任何前瞻性陳述均截至今日(2026 年 3 月 4 日)。
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 it's required by law.
如果今天之後重播或回顧此通話,則通話中提供的資訊可能不再是最新或準確的資訊。BillionToOne 聲明,除法律要求外,無論由於新資訊、未來事件或其他原因,均無義務公開更新任何前瞻性聲明。
And with that, I will turn the call over to Oguzhan.
接下來,我會把電話交給奧古贊。
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 fourth quarter and full-year 2025 earnings call. It has been a great year for BillionToOne. I want to begin by expressing how truly proud I am of what our team accomplished in 2025. This was the year we proved what disciplined and relentless execution can truly achieve.
大家下午好。感謝您參加我們2025年第四季及全年業績電話會議。對BillionToOne來說,今年是碩果累累的一年。首先,我想表達我對我們團隊在 2025 年所取得成就的由衷自豪。今年,我們證明了嚴明的紀律和堅持不懈的執行力能夠真正取得怎樣的成就。
This year, we did not just march our 20 miles. We did so by going public during a government shutdown that had frozen IPO markets and delivered, in my view, one of the most remarkable annual financial results in the history of molecular diagnostics. Let's look at our metrics.
今年,我們不僅完成了 20 英里的行軍。我們選擇在政府停擺、IPO市場凍結期間上市,並取得了在我看來分子診斷史上最卓越的年度財務表現之一。我們來看看各項指標。
Forget the Rule of 40. Our full year 2025 performance exceeded the Rule of 100. For the full year 2025, we achieved 100% year-over-year growth, with an adjusted EBITDA margin of 13%, a positive GAAP operating margin, and positive cash flow. Delivering an organic Rule of 100 is rare for any public company. In molecular diagnostics, I believe it may be unprecedented.
別再迷信40法則了。我們 2025 年全年的業績超過了 100 法則的預期值。2025 年全年,我們實現了 100% 的同比增長,調整後的 EBITDA 利潤率為 13%,GAAP 營業利潤率為正,現金流為正。對於任何一家上市公司來說,實現有機成長的「100法則」都是非常罕見的。我認為,這在分子診斷領域可能是前所未有的。
This revenue growth is driven by rapid increase in both test volume and ASPs. Our test volumes grew by 51% compared to full year 2024. Our ASP grew by 35%. At the same time, we continue to decrease our COGS and became more efficient. Our COGS per test decreased by more than 10%, even as we built our oncology business and processed vastly more oncology tests that have higher COGS. As a result, our gross margins improved by 15 percentage points. And as we incorporated AI and automation across all our functions, we achieved an even more remarkable increase in productivity, 36-percentage point improvement in our GAAP operating margin.
營收成長主要得益於測試量和平均售價的快速成長。與 2024 年全年相比,我們的測試量增加了 51%。我們的平均售價成長了35%。同時,我們的銷售成本持續下降,效率也越來越高。即使我們發展了腫瘤業務,處理了更多成本更高的腫瘤檢測,我們的每次檢測的成本仍然下降了 10% 以上。因此,我們的毛利率提高了15個百分點。隨著我們在所有職能部門引入人工智慧和自動化技術,我們的生產力得到了更顯著的提高,GAAP 營業利潤率提高了 36 個百分點。
This was due to an incredible combination of outperformance across all our teams. Our extremely strong sales team overachieved our test volume targets. Our R&D team continued to innovate, launching multiple products, including 14-gene single-gene NIPT ahead of the competition and response V2 with a 0.01% limit of detection.
這是由於我們所有團隊都表現出色,共同促成了這一結果。我們實力雄厚的銷售團隊超額完成了測試量目標。我們的研發團隊不斷創新,推出了多款產品,包括領先競爭對手的 14 基因單基因 NIPT 和檢測極限為 0.01% 的 response V2。
Our clinical affairs and market access teams obtained Medicare coverage for Northstar Select and signed 44 payer contracts, adding more than 25 million lives and reaching 250 million contracted lives in the United States.
我們的臨床事務和市場准入團隊為 Northstar Select 爭取到了 Medicare 的承保範圍,並簽署了 44 份支付方合同,新增了 2500 多萬人,使美國簽約人數達到 2.5 億。
And last but not least, our prenatal medical affairs team changed the standard of care and medical guidelines with UNITY Fetal Antigen NIPT. Truly, the performance of every single team has been exceptional in 2025. This is just the beginning of our journey as a public company, and I am looking forward to 2026 and beyond.
最後,我們的產前醫療事務團隊透過 UNITY 胎兒抗原 NIPT 改變了護理標準和醫療指南。的確,2025年每支球隊的表現都非常出色。這只是我們作為一家上市公司的旅程的開始,我期待著2026年及以後的發展。
As you know, at BillionToOne, we have four pillars of differentiation that we believe set us apart as a different type of molecular diagnostics company. Everything that we do starts with our revolutionary technology platform. This platform is enabled by our patented QCT, Quantitative Counting Templates technology, which achieves single molecule level sensitivity and precision with next generation sequencing. With our technology, we have built unique category-defining products in both prenatal and oncology.
如您所知,BillionToOne 擁有四大差異化支柱,我們相信這使我們成為一家與眾不同的分子診斷公司。我們所做的一切都始於我們革命性的技術平台。該平台採用我們專利的 QCT(定量計數模板)技術,透過下一代定序技術實現了單分子水平的靈敏度和精確度。憑藉我們的技術,我們在產前和腫瘤領域都打造了獨樹一幟的、定義品類的產品。
In prenatal, UNITY delivers comprehensive screening from a single blood row, reshaping the field of non-invasive prenatal testing. In oncology, Northstar Select detects 50% more actionable variants compared to other liquid biopsies, while Northstar Response gives oncologists the precise real-time read on how well a treatment is working. With these products, we have achieved exponential growth, even as we reached $384 million in annualized revenue run rate in the fourth quarter. That said, we believe that we are just scratching the surface of what is possible. With our technology, we believe that we are uniquely positioned to address more than $100 billion in US market opportUNITY over time.
在產前檢測方面,UNITY 只需一次血液檢查即可提供全面的篩檢,重塑了非侵入性產前檢測領域。在腫瘤學領域,與其他液體活檢相比,Northstar Select 可檢測到的可操作變異數量多 50%,而 Northstar Response 則可為腫瘤學家提供關於治療效果的精確即時讀數。憑藉這些產品,我們實現了指數級增長,第四季度年化收入運行率達到了 3.84 億美元。也就是說,我們相信目前所取得的成就只是冰山一角。我們相信,憑藉我們的技術,我們擁有獨特的優勢,能夠隨著時間的推移,抓住美國超過 1000 億美元的市場機會。
Moving on to our third pillar, BillionToOne has achieved a superior gross margin profile with margins reaching above 70%, despite subscale ASPs, particularly in oncology, and using only about one third of our current lab capacity.
接下來談談我們的第三個支柱,儘管平均售價低於市場水平(尤其是在腫瘤領域),而且只使用了我們目前實驗室產能的三分之一左右,但 BillionToOne 仍然實現了優異的毛利率,利潤率達到了 70% 以上。
Last but not least, I am perhaps most proud of our capital and operational efficiency, which enabled us to achieve GAAP profitability while growing at triple digit rates, which I believe is an unprecedented feat in molecular diagnostics. This combination of growth and profitability speaks to the uniqueness of our technology, which enables lower COGS, differentiation of our product portfolio, which results in extremely high sales efficiency, and our operational discipline.
最後,我最引以為傲的或許是我們的資本和營運效率,這使我們能夠在實現三位數成長的同時達到 GAAP 獲利,我認為這在分子診斷領域是一項前所未有的成就。成長與獲利能力的結合體現了我們技術的獨特性,它降低了銷售成本,實現了產品組合的差異化,從而提高了銷售效率,並增強了我們的營運紀律。
Our long-term goal remains the same; to build a category defining business and enter the S&P 500. Our fourth quarter performance allowed us to continue making important strides towards this goal, and the results are simply stunning. In fact, our fourth quarter performance exceeded all our expectations, including the guidance we provided in December.
我們的長期目標依然不變:打造定義產業的企業,並躋身標準普爾500指數。第四季的出色表現使我們能夠繼續朝著這個目標邁出重要步伐,而結果也令人驚嘆。事實上,我們第四季度的業績超出了我們所有的預期,包括我們在 12 月給出的預期。
Looking into the results pillar by pillar, first, since the end of the quarter, we have launched multiple products that further solidify our competitive advantage. In prenatal, we recently announced the dual launch of UNITY's expanded red blood cell UNITY Fetal Antigen NIPT, and first and only platelet Fetal Antigen NIPT.
從各方面來看,首先,自本季末以來,我們推出了多款產品,進一步鞏固了我們的競爭優勢。在產前檢測方面,我們最近宣布推出 UNITY 的擴展型紅血球 UNITY 胎兒抗原 NIPT 和第一個也是目前唯一的血小板胎兒抗原 NIPT。
In oncology, we launched Northstar PGx for pharmacogenomics and Northstar Select CH for clonal hematopoiesis. We also submitted and Northstar Response coverage dossier to MolDx, spanning five studies and three peer-reviewed publications. This is an exciting step toward gaining MolDx coverage for our Northstar Response test.
在腫瘤學領域,我們推出了用於藥物基因組學的 Northstar PGx 和用於克隆性造血的 Northstar Select CH。我們也向 MolDx 提交了一份 Northstar Response 報道檔案,涵蓋五項研究和三篇同行評審出版物。這是朝著獲得 MolDx 對 Northstar Response 測試的覆蓋範圍邁出的激動人心的一步。
With our differentiated products, we continue to see impressive rapid growth, with Q4 achieving 113% year-over-year revenue growth. This remarkable growth, which accelerated even compared to the first half of the year, was driven by 47% year-over-year test volume growth and 47% year-over-year ASP growth. In our third pillar, as our ASPs increased, and our COGS per test decrease, we expanded our gross margins by more than 14 percentage points year over year to 71.4% in the fourth quarter.
憑藉我們差異化的產品,我們持續保持著令人矚目的快速成長,第四季營收年增113%。這一顯著增長,甚至比上半年還要加速,是由檢測量同比增長 47% 和平均售價同比增長 47% 所推動的。在第三大支柱中,隨著平均售價 (ASP) 的提高和每次測試的銷售成本 (COGS) 的降低,我們的毛利率在第四季度同比增長超過 14 個百分點,達到 71.4%。
Lastly, we maintained a strong profitability profile in the quarter with an impressive 11% GAAP operating margin and 19% adjusted EBITDA margin. We ended the year with a strong balance sheet of $496 million in cash and only about $50 million in term debt.
最後,本季我們維持了強勁的獲利能力,GAAP 營業利潤率達到 11%,調整後 EBITDA 利潤率達到 19%。年底時,我們的資產負債表狀況良好,現金餘額為 4.96 億美元,長期債務僅約 5,000 萬美元。
Ross and I will expand on our quarterly financial results. But I'd like to first provide you with an update on our revolutionary technology platform and differentiated products.
羅斯和我將詳細介紹我們的季度財務表現。但我想先向大家介紹我們革命性的技術平台和差異化產品。
Starting with our first pillar, I am excited to announce that our current offering for Fetal Antigen NIPT is already changing the standard of care. As a reminder, our Fetal Antigen NIPT is the only test of its kind in the United States. It determines whether the fetus is positive or negative for various red blood cell antigens, such as Kell, when there is a risk of blood incompatibility between the mother and the fetus.
首先,我很高興地宣布,我們目前提供的胎兒抗原 NIPT 服務已經改變了護理標準。再次提醒,我們的胎兒抗原非侵入性產前檢測是美國唯一此類檢測。當母體和胎兒之間存在血液不相容的風險時,此檢測可以確定胎兒對各種紅血球抗原(如 Kell 抗原)是陽性還是陰性。
This occurs when a pregnant mother produces antibodies against the red blood cell antigen that may or may not be present in the fetus. This is a hugely important and severe problem for the patients and maternal fetal medicine specialists who manage them.
當孕婦體內產生針對胎兒可能存在也可能不存在的紅血球抗原的抗體時,就會發生這種情況。對於患者和負責治療他們的母胎醫學專家來說,這是一個極其重要且嚴重的問題。
These allo-uminized pregnancies are more common than any ploidies and in the absence of our tests, MFMs typically have to do weekly monitoring and tests to manage these high-risk pregnancies. Our UNITY Fetal Antigen NIPT, by determining whether the fetus is negative for the antigen against which the pregnant mother is producing antibodies, eliminates the need for costly and time-consuming monitoring in fetal antigen-negative pregnancies and removes the fear of the unknown for these patients.
這些異體黃化妊娠比任何倍體妊娠都常見,在沒有我們檢測手段的情況下,母胎醫學專家通常需要每週進行監測和檢測來管理這些高風險懷孕。我們的 UNITY 胎兒抗原 NIPT 透過確定胎兒是否對孕婦正在產生抗體的抗原呈陰性,消除了對胎兒抗原陰性妊娠進行昂貴且耗時的監測的需要,並消除了這些患者對未知情況的恐懼。
Importantly, In November, an expert committee of MFM key opinion leaders published a clinical practice guideline. And I believe its recommendations are stronger than any guidelines published in the cell-free DNA field for any tests in any setting. The committee wrote, and I quote, we recommend the use of cell-free fetal DNA to accurately determine the fetal red blood cell antigen status. drawn after 10 weeks gestational age in pregnancies complicated by alloimmunization.
值得注意的是,11 月,由母胎醫學領域關鍵意見領袖組成的專家委員會發布了一項臨床實踐指南。而且我認為,對於任何環境下的任何測試,它的建議都比無細胞 DNA 領域發布的任何指南更有力。委員會寫道(我引用原文),我們建議使用遊離胎兒DNA來準確確定妊娠10週後出現同種免疫併發症的胎兒紅血球抗原狀態。
And they further highlighted how reliable our results are by recommending that no further surveillance is needed for the remainder of the pregnancy after our NIPT determines that the fetus is negative. It is with this context that I am excited to announce that we recently expanded our Fetal Antigen NIPT and launched our first and only platelet Fetal Antigen NIPT at the Society for Maternal Fetal Medicine Conference in February.
他們進一步強調了我們結果的可靠性,建議在我們的 NIPT 檢測結果為陰性後,無需在剩餘的懷孕期間進行進一步監測。正是在這種背景下,我很高興地宣布,我們最近擴大了胎兒抗原 NIPT 的範圍,並在 2 月的母胎醫學學會會議上推出了我們第一個也是唯一一個血小板胎兒抗原 NIPT。
As I mentioned, for MFMs, this is one of the most important problems in prenatal care. And the reception to our product launch was extremely positive. We have had more than 100 physicians attend our dinner presentations across three venues during the conference, an absolute record for us for any conferences we have ever participated in, in addition to a conference presentation that was standing room only with more than 100 additional attendees.
正如我之前提到的,對於母胎醫學專家來說,這是產前護理中最重要的問題之一。我們的產品發布反應非常正面。會議期間,我們在三個場地舉辦的晚宴演講吸引了超過 100 位醫生參加,這在我們參加過的所有會議中都是絕對的紀錄。此外,還有一場會議演講座無虛席,吸引了超過 100 位與會者。
With this dual launch, first, we expanded the antigens we detect for red blood cells. now covering 99% of antigens associated with hemolytic disease of the fetus and newborn, or HDFN. In addition, we launched the first and only NIPT for platelet incompatibility, addressing FNAIT. FNAIT is a severe condition that may lead to catastrophic fetal outcomes, including intracranial hemorrhage or fetal loss. These fetal antigen tests are available exclusively through our UNITY Aneuploidy Screen with no additional order or blood draw needed.
透過此次雙重發布,首先,我們擴大了對紅血球抗原的檢測範圍,現在已涵蓋與胎兒和新生兒溶血病(HDFN)相關的 99% 的抗原。此外,我們推出了首個也是目前唯一針對血小板不相容的 NIPT,用於解決 FNAIT 問題。FNAIT 是一種嚴重的疾病,可能導致災難性的胎兒後果,包括顱內出血或胎兒死亡。這些胎兒抗原檢測僅可透過我們的 UNITY 非整倍體篩檢取得,無需額外訂購或抽血。
This is a powerful demonstration of the depth of our smNGS platform. As I mentioned, these high-risk pregnancies are more common than Aneuploidy's, and we are excited about the clinical impact these expansions will have. We believe these tests have tremendous potential to help patients who would otherwise need weekly monitoring, testing, intervention, and management by MFMs.
這有力地展示了我們 smNGS 平台的深度。正如我之前提到的,這些高風險懷孕比非整倍體懷孕更為常見,我們對這些擴展將產生的臨床影響感到興奮。我們相信這些檢測具有巨大的潛力,可以幫助那些原本需要母胎醫學專家每週進行監測、檢測、介入和管理的患者。
In oncology, after the end of the quarter, we launched two important upgrades to Northstar Select, two add-on tests for pharmacogenomics and clonal hematopoiesis. The launch of these applications for Northstar Select expands our product to address two critical decision points in therapy selection. They also keep us aligned with evolving oncology treatment guidelines information that is increasingly relevant to how oncologists select therapies.
在腫瘤學領域,本季結束後,我們推出了 Northstar Select 的兩項重要升級,即藥物基因組學和克隆造血的兩項附加測試。Northstar Select 的這些應用程式的推出,擴展了我們的產品,以解決治療選擇中的兩個關鍵決策點。它們還能讓我們及時了解不斷發展的腫瘤治療指南訊息,這些資訊對於腫瘤科醫生選擇治療方案越來越重要。
The PGx add-on provides pharmacogenomic insight into key variants for chemotherapy dosing. From the same blood sample and within the same five-day average turnaround time, Northstar PGx can report a patient's predicted metabolizer status and associated clinical implications. This enables the physician to use the right dose for each patient, preventing severe toxicity, reducing hospitalizations, and improving safety and quality of life.
PGx 附加組件可提供化療劑量關鍵變異的藥物基因組學見解。Northstar PGx 僅需同一份血液樣本,即可在平均五天的周轉時間內報告患者的預測代謝狀態及其相關的臨床意義。這樣一來,醫師就能為每位患者使用適當的劑量,防止嚴重毒性反應,減少住院治療,提升安全性和生活品質。
Northstar Select CH addresses clonal hematopoiesis, the most common source of biological false positives in cell-free DNA testing. An incredible 25% of patients harbor at least one CH mutation in an actionable gene. These CH mutations are derived from white blood cells, not the tumor. In other words, they are biological false positives. and they can lead to the administration of ineffective therapies. Northstar Select CH combines targeted white blood cell sequencing for all guideline recommended genes with proprietary machine learning classification for all other genes, achieving greater than 99% accuracy in distinguishing tumor-derived alterations from non-tumor findings.
Northstar Select CH 可解決克隆性造血問題,這是無細胞 DNA 檢測中最常見的生物學假陽性來源。令人難以置信的是,25% 的患者至少攜帶一個可治療基因中的 CH 突變。這些 CH 突變來自白血球,而不是腫瘤。換句話說,它們是生物學上的假陽性結果,可能導致無效治療的實施。Northstar Select CH 結合了針對所有指南推薦基因的靶向白血球測序和針對所有其他基因的專有機器學習分類,在區分腫瘤衍生改變和非腫瘤發現方面實現了 99% 以上的準確率。
We believe that Northstar Select CH is highly differentiated from other offerings as it delivers more accurate, trusted liquid biopsy results. While we previously showed that Northstar Select is significantly more sensitive than other liquid biopsy comparators, we believe that this offering will also make it the liquid biopsy with the highest specificity. As awareness of the CH problem increases among physicians, we expect that white blood cell testing will be an important driver of their choice of liquid biopsy. Both PGx and CH are ordered as add-ons during Northstar select testing and they are integrated into the same report. These upgrades ensure that we remain at the forefront of therapy selection.
我們相信 Northstar Select CH 與其他產品有很大的不同,因為它能提供更準確、更值得信賴的液體活檢結果。雖然我們之前已經證明 Northstar Select 比其他液體活檢產品更靈敏,但我們相信,此次推出的產品也將使其成為特異性最高的液體活檢產品。隨著醫生對 CH 問題的認識不斷提高,我們預計白血球檢測將成為他們選擇液體活檢的重要驅動因素。PGx 和 CH 都是在 Northstar 選擇測試期間作為附加項訂購的,並且它們被整合到同一份報告中。這些升級確保我們在治療方案選擇方面始終處於領先地位。
Turning to our second pillar, our leadership in product innovation and our growing commercial team continue to drive our test volume, with Q4 reaching approximately 170,000 tests, a 47% year-over-year increase. We saw strong quarter-over-quarter growth across both prenatal and oncology, despite Q4 being a seasonally slower quarter with fewer accessioning days.
再來看我們的第二個支柱,我們在產品創新方面的領先地位以及不斷壯大的商業團隊繼續推動著我們的測試量,第四季度測試量達到約 17 萬次,同比增長 47%。儘管第四季度是季節性淡季,接收病例天數較少,但我們在產前和腫瘤領域都實現了強勁的季度環比增長。
Importantly, in Q4, we added a record number of new active ordering providers, setting us up, we believe, for a strong performance in Q1 2026. This is a metric that we track closely, and we are encouraged by the momentum. Our sales team continues to operate with extremely high sales efficiency and we continue to expand our commercial team at a systematic pace.
重要的是,在第四季度,我們新增了創紀錄數量的活躍訂購提供商,我們相信,這將為我們在 2026 年第一季取得強勁業績奠定基礎。這是我們密切關注的一項指標,我們對目前的成長動能感到鼓舞。我們的銷售團隊持續保持極高的銷售效率,我們也有條不紊地擴大我們的商業團隊。
Our total revenue performance in the fourth quarter demonstrates the exponential growth we have delivered since 2021, rising from approximately zero to $384 million in ARR in approximately five years. Total revenue in the fourth quarter was $96.1 million, representing 113% year-over-year growth, driven by rapid increases in test delivered and ASPs across both product lines. This sustained level of growth at our scale is truly differentiated in our industry.
我們在第四季度的總收入表現表明,自 2021 年以來,我們實現了指數級增長,在短短五年內,年度經常性收入 (ARR) 從大約零增長到 3.84 億美元。第四季總收入為 9,610 萬美元,年增 113%,這主要得益於測試交付量和兩條產品線的平均售價的快速增長。我們這種規模下持續成長的水平,在業界是真正與眾不同的。
This outperformance was driven by rapid growth in both prenatal and oncology revenues. In the fourth quarter, prenatal revenue was $86.9 million, up 98% year over year, reaching an annualized run rate of $348 million. Our prenatal revenues continue to grow at a pace that underscores the depth of our unit differentiation. Our oncology revenue continued to grow even faster than prenatal, reaching $9.1 million in the fourth quarter, achieving $36 million annualized revenue run rate. This is up 736% year over year. The oncology ramp has been driven by increasing adoption of both select and response, execution by our oncology commercial team, and the benefit of MolDx coverage for Select secured earlier in the year.
這項優異業績主要得益於產前和腫瘤業務收入的快速成長。第四季度,產前收入為 8,690 萬美元,年增 98%,年化運作率為 3.48 億美元。我們的產前收入持續成長,這凸顯了我們產品差異化的深度。我們的腫瘤業務收入持續保持成長勢頭,甚至超過了產前業務,第四季達到 910 萬美元,年化收入達到 3,600 萬美元。與去年同期相比成長了736%。腫瘤業務的成長得益於 Select 和 Responsibility 的日益普及、我們腫瘤商業團隊的執行,以及今年早些時候 MolDx 對 Select 的覆蓋範圍所帶來的益處。
In particular, excluding through-up revenue, our oncology revenue grew 29% quarter over quarter, driven primarily by increase in our test volume. With the addition of PGx and CHIP in Q1, we expect our 2026 test volume growth to be even stronger. We continue to see a significant opportUNITY ahead as we grow our sales team, build clinical evidence, and pursue Medicare coverage for Northstar Response.
特別是,若不計入其他業務收入,我們的腫瘤業務收入較上季成長 29%,主要得益於檢測量的增加。隨著 PGx 和 CHIP 在第一季的加入,我們預計 2026 年的測試量成長將更加強勁。隨著我們銷售團隊的壯大、臨床證據的累積以及為 Northstar Response 爭取 Medicare 保險覆蓋,我們繼續看到未來存在著巨大的機會。
In addition to our test volume growth, our overall ASP also continues to grow rapidly. Overall ASP increased another 12% quarter-over-quarter from $501 to $561, a significant $60 per test increase in a single quarter. For the full year 2025, our overall ASP increased from $368 in 2024 to $495 in 2025, a 35% year-over-year ASP increase.
除了測試量成長外,我們的整體平均售價也持續快速成長。整體平均售價季增 12%,從 501 美元增至 561 美元,單季內每次測試價格大幅上漲 60 美元。2025 年全年,我們的整體平均售價從 2024 年的 368 美元增至 2025 年的 495 美元,年增 35%。
The Q4 sequential step-up of $60 per test is meaningful and reflects several converging tailwinds. Additional Medicaid states adopting our carrier PLA code, the continued build-out of our contracted payer base, and a growing contribution from oncology, where Northstar Select has a much higher ASP than any of our other tests.
第四季每次測試價格遞增 60 美元意義重大,反映了幾個相互交匯的利多因素。更多 Medicaid 州採用我們的核保人 PLA 代碼,我們的簽約付款人基礎不斷擴大,以及腫瘤科的貢獻日益增長,Northstar Select 在腫瘤科的平均售價比我們的任何其他檢測都要高得多。
We believe there remains substantial room for ASP expansion, as we add more payer contracts and as guidelines continue to broaden the clinical indications for our tests. We are particularly excited about the prospect of the Northstar Response coverage. As Northstar Response, due to its repeat nature, accounts for almost two-thirds of our oncology test volume, any increase in Northstar Response coverage and ASPs would meaningfully expand our oncology revenue.
我們相信,隨著我們增加更多支付方合同,以及指南不斷擴大我們檢測的臨床適應症,ASP仍有很大的擴張空間。我們對 Northstar Response 的報道前景感到格外興奮。由於 Northstar Response 具有重複性,占我們腫瘤檢測量的近三分之二,因此 Northstar Response 覆蓋範圍和 ASP 的任何增加都將顯著擴大我們的腫瘤收入。
In addition to driving ASP growth, we have remained committed to our operating philosophy of continuous improvement to reduce COGS per test. Our overall COGS per test was $161 in Q4, down 4% year over year. I will note that COGS per test was slightly higher compared to the last quarter. This was primarily driven by a significant continued shift toward a higher proportion of oncology tests, which have higher COGS and ASP per test.
除了推動平均售價成長外,我們還始終秉持持續改善的經營理念,以降低每次測試的成本。第四季度,我們每次測試的總銷售成本為 161 美元,年減 4%。需要指出的是,每次測試的銷貨成本都比上一季略高。這主要是由於腫瘤檢測的比例持續大幅增加所致,而腫瘤檢測的成本和平均售價都較高。
It was also impacted by higher stock-based compensation expense as a public company. To sustain our trajectory of reducing the COGS-Per-Test, we continue to deploy AI and automation across our laboratory operations. As our ASPs increased and as our COGS-Per-Test decreased year over year, our gross margin profile continued to expand in the fourth quarter. Gross margins were 71.4% in Q4, representing a 14.3 percentage point year-over-year increase, and a modest increase quarter-over-quarter from 70% in Q3. The increase in gross margins was primarily attributable to higher overall ASPs and continued progress in reducing our COGS per test, especially in oncology.
作為一家上市公司,其股權激勵支出也較高,這對其業績造成了影響。為了保持降低每次檢測成本的趨勢,我們將繼續在實驗室營運中部署人工智慧和自動化技術。隨著我們的平均售價逐年上漲,而每次測試的銷售成本逐年下降,我們的毛利率在第四季度繼續擴大。第四季毛利率為 71.4%,年增 14.3 個百分點,季比第三季的 70% 略有成長。毛利率的提高主要歸功於整體平均售價的提高以及我們在降低每次檢測的成本方面取得的持續進展,尤其是在腫瘤學領域。
What is particularly noteworthy is that gross margins continue to increase despite the higher volume contribution from oncology, which currently has lower margins than prenatal. We are encouraged by the margin trajectory in both segments, and while the mix shift to oncology will limit substantial near-term margin expansion, we expect to maintain our gross margins near current levels.
尤其值得注意的是,儘管腫瘤科的業務量貢獻較大,但毛利率仍在持續成長,而腫瘤科目前的利潤率低於產前科。我們對這兩個業務板塊的利潤率走勢感到鼓舞,雖然向腫瘤領域的業務組合轉變會限制短期內利潤率的大幅擴張,但我們預計毛利率將保持在目前的水平附近。
Last but not least, in our fourth pillar, we achieved GAAP profitability in both Q4 2025 and full year 2025, with year-over-year improvements of 29 percentage points in net margin and 36 percentage points in operating margin. This was due to a number of factors: increasing and high sales efficiency, increasing ASPs, reductions in COGS-Per-Test, and our relentless focus on increasing productivity across all our operations through automation and AI.
最後,也是非常重要的一點,在我們的第四大支柱中,我們在 2025 年第四季度和 2025 年全年均實現了 GAAP 盈利,淨利潤率同比增長 29 個百分點,營業利潤率同比增長 36 個百分點。這主要歸功於以下幾個因素:不斷提高的銷售效率、不斷提高的平均售價、降低的每次測試的銷售成本,以及我們透過自動化和人工智慧不斷提高所有營運環節的生產力。
Iâd like to note that we have achieved this profitability at a much lower scale than our competitors while growing faster and with less than 10% of their accumulated deficits. With that, I will turn the call over to Russ to review our financial results and 2026 guidance before I conclude.
我想指出的是,我們在遠低於競爭對手的規模下實現了這樣的獲利能力,同時成長速度更快,累計虧損不到他們的 10%。接下來,我將把電話交給 Russ,讓他回顧我們的財務表現和 2026 年的業績展望,之後我再結束演講。
Ross Taylor - Chief Financial Officer
Ross Taylor - Chief Financial Officer
Thank you, Oguzhan. As Oguzhan noted, total revenue in the fourth quarter of 2025 was $96.1 million, compared to $45.1 million in the fourth quarter of 2024, representing an increase of 113%.
謝謝你,奧古詹。正如奧古贊所指出的,2025 年第四季的總收入為 9,610 萬美元,而 2024 年第四季為 4,510 萬美元,成長了 113%。
Revenue growth for both our prenatal and oncology product lines was strong in the quarter. Prenatal revenues, consisting of clinical testing revenues of $86.1 million and $800 thousand in revenues from clinical trial support and other services, increased 98% to $86.9 million in Q4. Oncology revenues increased 736% to $9.1 million in Q4 of 2025 versus Q4 last year.
本季度,我們產前和腫瘤產品線的收入成長都很強勁。第四季度,產前收入(包括 8,610 萬美元的臨床檢測收入和 80 萬美元的臨床試驗支援及其他服務收入)成長了 98%,達到 8,690 萬美元。2025 年第四季腫瘤業務營收較去年同期成長 736%,達到 910 萬美元。
True up revenue across both product lines was $8.4 million in the fourth quarter, compared to $1.1 million in the fourth quarter of last year, reflecting higher cash collection trends related to tests delivered in prior periods. Revenues in the quarter were higher than the guidance we provided on December 9 of a range of $84 million to $90 million for Q4. About two-thirds of the higher Q4 revenues compared to this range was driven by higher test volumes than we expected, and one-third was caused by higher true up revenue compared to our estimate.
在第四季度,兩條產品線的最終收入為 840 萬美元,而去年同期為 110 萬美元,這反映出與先前交付的測試相關的現金回收趨勢有所提高。本季營收高於我們 12 月 9 日給出的第四季 8,400 萬美元至 9,000 萬美元的預期。第四季營收高於預期範圍,其中約三分之二是由於測試量高於預期,三分之一是由於實際營收高於預期。
Gross profit in the fourth quarter of 2025 was $68.6 million, compared to $25.7 million in the fourth quarter of 2024, resultinper test g in a gross margin of 71.4% in the fourth quarter of 2025 versus 57% in the fourth quarter of 2024.
2025 年第四季毛利為 6,860 萬美元,而 2024 年第四季為 2,570 萬美元,因此 2025 年第四季毛利率為 71.4%,而 2024 年第四季毛利率為 57%。
Importantly, ASPs and COGS-Per-Test improved across all of our product lines year over year. Total operating expenses were $58.3 million in the fourth quarter of 2025, compared to $37.4 million in the comparable prior year quarter, representing an increase of 56%.
重要的是,我們所有產品線的平均售價和每次測試的成本都逐年提高了。2025 年第四季總營運支出為 5,830 萬美元,而去年同期為 3,740 萬美元,成長了 56%。
Within operating expenses, R&D expense was $14.3 million in the fourth quarter of 2025, compared to $11 million in the comparable prior year quarter, while SG&A expense was $44 million in the fourth quarter of 2025, compared to $26.4 million last year. We continued to scale our operating expenses to support rapid growth with efficiency and discipline.
在營運費用方面,2025 年第四季的研發費用為 1,430 萬美元,而上年同期為 1,100 萬美元;2025 年第四季的銷售、一般及行政費用為 4,400 萬美元,而去年同期為 2,640 萬美元。我們持續調整營運支出規模,以高效率、自律的方式支援快速成長。
Operating income was $10.3 million in the fourth quarter of 2025, compared to an operating loss of $11.7 million in the fourth quarter of 2024. Our Q4 operating profit margin was 11%. We expect to operate the business such that we continue to generate positive GAAP operating income in the future.
2025 年第四季營業收入為 1,030 萬美元,而 2024 年第四季營業虧損為 1,170 萬美元。我們第四季的營業利益率為11%。我們期望透過持續經營,在未來繼續創造正的GAAP營業收入。
Net income available to common shareholders was $4.4 million, or $0.11 per diluted share in the fourth quarter of 2025, compared to a net loss of $11.5 million, or $1.13 per diluted share for the same period in 2024.
2025 年第四季歸屬於普通股股東的淨利為 440 萬美元,即每股攤薄收益 0.11 美元,而 2024 年同期淨虧損為 1,150 萬美元,即每股攤薄虧損 1.13 美元。
Turning briefly to 2025 financial highlights. Total revenue of $305.1 million was above our guidance range and 100% higher than the $152.6 million we reported in 2024. True up revenue is $17.1 million for the full year of 2025, compared to $11.2 million in 2024. The number of tests delivered in 2025 grew 51% to 610,000, and our overall ASP grew 35% to $495.
接下來簡單展望一下2025年的財務亮點。總收入為 3.051 億美元,高於我們的預期範圍,比我們 2024 年報告的 1.526 億美元高出 100%。2025 年全年調整後的收入為 1,710 萬美元,而 2024 年為 1,120 萬美元。2025 年提供的檢測數量增加了 51%,達到 61 萬次,我們的整體平均售價增加了 35%,達到 495 美元。
Operating income for 2025 was $16.0 million versus an operating loss of $47.1 million in 2024. Our operating profit margin was 5% for the full year of 2025.
2025 年營業收入為 1,600 萬美元,而 2024 年營業虧損為 4,710 萬美元。2025 年全年,我們的營業利益率為 5%。
Adjusted EBITDA was $38.8 million, representing a 13% margin. We achieved these margins while investing meaningfully in our sales force, new product launches, and clinical evidence generation.
調整後 EBITDA 為 3,880 萬美元,利潤率為 13%。我們在銷售團隊、新產品發布和臨床證據產生方面進行了大量投資,同時實現了這些利潤率。
Our cash flow is strong. Cash flow from operations minus capital expenditures was $9 million in Q4 of 2025 and $16 million for all of 2025. For modeling purposes, we anticipate diluted shares outstanding to be in a range of 52 million to 54 million over the next several quarters.
我們的現金流狀況良好。2025 年第四季經營活動產生的現金流量減去資本支出為 900 萬美元,2025 年全年經營活動產生的現金流量減去資本支出 1,600 萬美元。出於建模目的,我們預計未來幾季稀釋後的流通股數量將在 5,200 萬股至 5,400 萬股之間。
We are well-capitalized with a very healthy balance sheet. We ended the year with approximately $496 million in cash and equivalents and just $50 million in term debt, positioning us for strong growth moving forward.
我們資金雄厚,資產負債表非常健康。年底時,我們擁有約 4.96 億美元的現金及等價物,以及僅 5,000 萬美元的定期債務,為我們未來的強勁成長奠定了基礎。
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 $430 million to $445 million, representing growth of 41% to 46% compared to full year 2025. We continue to expect positive GAAP operating income for the full year of 2026. Our new revenue guidance is a $15 million increase at both ends of the range over our previous guidance provided in early January of $415 million to $430 million.
最後,我將提供我們 2026 年全年業績指引的最新資訊。我們將 2026 年總營收預期上調至 4.3 億美元至 4.45 億美元,與 2025 年全年相比成長 41% 至 46%。我們仍預期 2026 年全年將實現正的 GAAP 營業收入。我們新的營收預期比 1 月初給出的 4.15 億美元至 4.3 億美元的預期分別提高了 1500 萬美元。
I will now turn the call back to Ozan to elaborate on the guidance and to conclude.
現在我將把電話轉回給奧贊,讓他詳細闡述指導意見並作總結。
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. I would like to highlight that we have several additional growth drivers and catalysts in both prenatal and oncology that give us strong conviction that even our raised guidance is conservative.
謝謝你,羅斯。我想強調的是,我們在產前和腫瘤領域還有幾個額外的成長驅動因素和催化劑,這讓我們堅信,即使我們提高了預期,也是保守的。
On the prenatal side, we see such strong continued momentum. We believe that the recently published clinical practice guideline will further position UNITY as the new standard in prenatal care, and BillionToOne as the leading innovator in this field. The dual launch of our expanded red blood cell Fetal Antigen NIPT and first and only platelet Fetal Antigen NIPT at SMFM will further drive our growth.
在產前方面,我們看到瞭如此強勁的持續發展勢頭。我們相信,最近發布的臨床實踐指南將進一步鞏固 UNITY 作為產前護理新標準的地位,並使 BillionToOne 成為該領域的領先創新者。在SMFM,我們將同時推出擴大的紅血球胎兒抗原NIPT和首個也是目前唯一的血小板胎兒抗原NIPT,這將進一步推動我們的成長。
As awareness and practice guideline-driven adoption accelerate, we expect meaningful volume uplift in health systems where MFMs are the decision-makers. Such health system adoption is not reflected in our guidance.
隨著人們意識的提高和實踐指南的推動,我們預計在母胎醫學專家擔任決策者的醫療系統中,業務量將顯著提升。我們的指導方針中並未體現這種醫療體系的採用方式。
We also see continued ASP tailwinds from increased Medicaid coverage of our carrier panel PLA code. 0449U has been added to 10 Medicaids in 2025, the largest of which has happened in Q4, with Florida starting to cover 0449U in Q1 2026. Each Medicaid addition can drive ASP increases and lead to further contracting with managed care organizations, MCOs, further driving our test volume in a flywheel.
我們也看到,由於醫療補助計劃對我們核保員PLA代碼的覆蓋範圍擴大,ASP持續受益。0449U 已於 2025 年添加到 10 個醫療補助計劃中,其中規模最大的發生在第四季度,佛羅裡達州於 2026 年第一季開始涵蓋 0449U。每增加一名 Medicaid 患者,都可能推動 ASP 上漲,並導致與管理式醫療機構 (MCO) 簽訂更多合同,從而在飛輪效應中進一步推動我們的測試量。
We also have several health systems that want to use UNITY as their prenatal screening of choice, with the only remaining blocker being the EMR integration. While the start of Epic Aura integrations is likely six months from now, and therefore their contribution is not reflected in our guidance, adoption even in a single health system can be a significant upside to our projections.
我們還有幾家醫療機構希望使用 UNITY 作為其首選的產前篩檢系統,目前唯一阻礙因素是 EMR 整合。雖然 Epic Aura 整合可能還要六個月後才會開始,因此它們的貢獻尚未反映在我們的指導意見中,但即使在單一醫療系統中採用,也能顯著提高我們的預測。
In oncology, the launch of Northstar Select PGx and Northstar Select CH broadened our oncology offering and deepened our value proposition for oncologists. As our test volumes grow, we are able to further drive our COGS-Per-Test down and enable additional product innovation, including a best-in-class tumor-naive MRD that we aim to launch by the end of the year. Each of these is an independent driver of growth that compounds with the others.
在腫瘤領域,Northstar Select PGx 和 Northstar Select CH 的推出拓寬了我們的腫瘤產品範圍,並深化了我們為腫瘤科醫生提供的價值主張。隨著我們的檢測量不斷增長,我們能夠進一步降低每次檢測的成本,並實現更多的產品創新,包括我們計劃在年底前推出的同類最佳的腫瘤初治 MRD 檢測。這些因素各自都是獨立的成長驅動力,彼此之間又相互促進。
Our Northstar Response MolDx coverage submission represents a meaningful catalyst. We submitted a comprehensive coverage dossier to MolDx, an approval received even a few months before the end of the year would be a meaningful upside to our 2026 oncology revenue, given that Northstar Response accounts for nearly two-thirds of our oncology test volume. There is a catalyst I want to spend a moment on specifically because I believe it can be quite significant for us in 2026.
我們提交的 Northstar Response MolDx 保險覆蓋範圍申請具有重要的推動意義。我們向 MolDx 提交了一份全面的保險覆蓋範圍文件,考慮到 Northstar Response 占我們腫瘤檢測量的近三分之二,即使在年底前幾個月獲得批准,也將對我們 2026 年的腫瘤收入產生顯著影響。我想花點時間專門談談一個催化劑,因為我相信它對我們2026年的發展可能意義重大。
In addition to the above drivers, I am extremely excited to share that we have just signed a contract to be in-network with UnitedHealthcare, the largest commercial health insurer in the United States. This is a landmark moment for BillionToOne, and I want to take a moment to convey why.
除了上述因素外,我非常興奮地宣布,我們剛剛與美國最大的商業健康保險公司 UnitedHealthcare 簽署了一份合作協議,成為其網路供應商。對於 BillionToOne 來說,這是一個具有里程碑意義的時刻,我想藉此機會解釋一下原因。
When we are out of network, patients can still access our tests, but this can create significant friction with both physicians and patients. It also results in lower ASPs, as patient collections can be unpredictable and challenging. An in-network contract removes all that friction at once. I believe our contracting with other payers will further accelerate in 2026, driving both additional test volume and ASPs. Our market access team has built an outstanding foundation. I am incredibly proud of them.
即使我們不在醫療保險網絡內,患者仍然可以接受我們的檢測,但這可能會給醫生和患者帶來很大的摩擦。這也會導致平均售價降低,因為患者收款可能難以預測且充滿挑戰。網路內合約可以一次消除所有這些摩擦。我相信,到 2026 年,我們與其他支付方的合約將進一步加快,從而推動檢測量和平均銷售價格的增加。我們的市場准入團隊已經打下了堅實的基礎。我為他們感到無比驕傲。
In summary, we are transforming healthcare one molecule at a time, one patient at a time. We have changed what the industry believed was possible in cell-free DNA diagnostics, and we are just getting started. Winning from here requires continued exceptional execution, and I am confident that our team, our technology, and our products position us to deliver on that.
總而言之,我們正在以分子為單位,以患者為單位,逐步改變醫療保健產業。我們改變了業界對無細胞 DNA 診斷可能性的認知,而這只是個開始。要繼續取得勝利,需要持續卓越的執行力,但我相信我們的團隊、技術和產品能夠幫助我們實現這一目標。
In Q4, we continued our exceptional execution in our 20-mile march. From the Northstar Response MolDx submission to multiple product launches to setting an all-time record for newly active ordering providers, our team is driving every pillar of the business forward simultaneously.
第四季度,我們在20英里的征程中繼續保持了卓越的執行力。從 Northstar Response MolDx 的提交到多個產品的推出,再到創下新活躍訂購供應商數量的歷史新高,我們的團隊正在同時推動業務的各個支柱向前發展。
Indeed, in Q4, we expanded gross margin and maintained GAAP profitability even as we absorbed one-time IPO-related costs and invested at an accelerating pace. What gives me the most confidence as I look forward is not any single catalyst. It is the compounding nature of everything we have built.
事實上,在第四季度,我們擴大了毛利率,並保持了 GAAP 獲利能力,即使我們承擔了與 IPO 相關的一次性成本,並且投資速度加快。展望未來,最讓我充滿信心的並非任何單一的催化劑。這是我們所建立的一切事物的累積特性。
Our smNGS platform gets more powerful with each new product we launch. Our clinical evidence base grows with every study we publish. Our commercial organization becomes more efficient with every new active provider we onboard, and our market access position gets stronger with every payer contract we sign, including the landmark agreement we just announced. We have a team of driven, purpose-built individuals who come to work every day to improve patientsâ lives. That commitment is what fuels everything you see in these results.
隨著我們推出每一款新產品,我們的smNGS平台的功能都會變得更加強大。我們發表的每項研究都會增加我們的臨床證據基礎。隨著我們不斷吸收新的活躍供應商,我們的商業組織效率也會不斷提高;隨著我們簽署的每一份支付方合約(包括我們剛剛宣布的具有里程碑意義的協議),我們的市場准入地位也會不斷增強。我們擁有一支充滿幹勁、目標明確的團隊,他們每天來上班都是為了改善病患的生活。正是這種投入成就了你所看到的這些成果。
Our long-term ambition is to build a category-defining company, enter the S&P 500, and continue to transform healthcare one molecule at a time, one patient at a time. Every quarter, we are excited to take another step in that direction, and I believe 2026 will be our most consequential year yet.
我們的長期目標是打造一家引領產業的公司,躋身標準普爾 500 指數,並繼續透過一次一個分子、一次一個病人的方式改變醫療保健產業。每個季度,我們都滿懷熱情地朝著這個方向邁出新的一步,我相信 2026 年將是我們迄今為止最重要的一年。
Thank you. Over to the operator.
謝謝。交給操作員。
Operator
Operator
(Operator Instructions) Andrew Brackmann, William Blair.
(操作說明)安德魯·布拉克曼,威廉·布萊爾。
Andrew Brackmann - Analyst
Andrew Brackmann - Analyst
Hi, guys. Good afternoon. Thanks for all the remarks. Certainly lot to dig into. Oguzhan, you mentioned the continued expansion of the prenatal portfolio as you continue to push that field forward. And certainly, I would think that this sort of increases the awareness of UNITY among certain providers.
嗨,大家好。午安.感謝大家的意見。確實有很多值得深入探討的地方。奧古贊,您提到隨著您不斷推進產前領域,產前產品組合也持續擴展。當然,我認為這會提高某些服務提供者對 UNITY 的認識。
If you could zoom out, can you maybe just sort of talk about where you think awareness is for all providers who order NIPT, both those who manage low risk and high risk pregnancies? And then how do you sort of think about driving that higher in 2026 and beyond? Thank you.
如果可以的話,您能否從更宏觀的角度談談您認為所有開立 NIPT 檢測單的醫護人員,包括那些管理低風險妊娠和高風險妊娠的醫護人員,對 NIPT 的認知程度如何?那麼,您認為應該如何推動這一數字在 2026 年及以後繼續成長?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. Very good question. And actually, this is one of the reasons why we believe we have such a long runway for our continued growth. You know, I think this comes up in some of the surveys that, you know, analysts and others, including you, have put together. But what we see in our own data that, you know, around epending on whether it is aided or unaided recall, at least 50% of providers do not know anything about UNITY.
謝謝你,安德魯。問得好。事實上,這也是我們相信未來還有很長成長之路的原因之一。你知道,我認為在一些調查中也提到了這一點,這些調查是由分析師和其他人(包括你)共同進行的。但我們從自己的數據中看到,根據是輔助回憶還是非輔助回憶,至少有 50% 的提供者對 UNITY 一無所知。
So that actually is a remarkable outcome that often providers who know about UNITY, we actually have more than 50% market share or so. Around unaided awareness is around, I think, 30%, aided awareness is around 50%. So if you look at kind of those numbers, and we look at essentially what percentage of them are actually using UNITY, we have about 50% market share if a provider knows about our tests.
所以這確實是一個了不起的結果,因為通常了解 UNITY 的供應商,實際上我們擁有超過 50% 的市佔率。我認為,未經幫助的意識程度約為 30%,有幫助的意識程度約為 50%。所以,如果你看一下這些數字,再看看實際使用 UNITY 的用戶佔比是多少,如果供應商了解我們的測試,我們就能獲得大約 50% 的市場份額。
So from that perspective, we believe that as we continue to increase our sales team size, as we continue to cover the entirety of the United States fully, and as we continue to publish and have these clinical guideline changes and other additional products with UNITY, we believe that this awareness is going to increase and that is going to be a really big driver of our long-term growth.
因此,從這個角度來看,我們相信,隨著我們不斷擴大銷售團隊規模,不斷全面覆蓋美國全境,不斷發布臨床指南變更以及推出更多 UNITY 產品,我們相信這種認知度將會提高,而這將成為我們長期增長的真正重要驅動力。
Andrew Brackmann - Analyst
Andrew Brackmann - Analyst
Okay, thanks for all that color. And then maybe if I could just follow up the commentary around health systems where MFMs are an important decision-maker there. Can you maybe just sort of talk about the conversations that you're having with those groups in particular around sort of driving uptake across these larger groups? Thanks for taking the questions.
好的,謝謝你們帶來的繽紛色彩。然後,也許我可以繼續探討醫療系統中母胎醫學專家作為重要決策者的角色。您能否談談您正在與這些群體進行的對話,特別是關於如何提高這些更廣泛群體的接受度?謝謝您回答問題。
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Certainly. MFMs are an important stakeholder, right? They are usually the ones that are taking care of the high-risk pregnancies. And when any NIPT determines a high-risk result, usually these patients are referred to MFMs. So from that perspective, MFMs have tremendous influence over the tests that the OBs, who are referring their high-risk patients to them, have.
當然。MFM(母嬰保健經理)是重要的利害關係人,對嗎?他們通常負責照顧高危險妊娠病例。當任何 NIPT 檢測結果顯示高風險時,通常這些患者會被轉介至母胎醫學專家。因此從這個角度來看,母胎醫學專家對婦產科醫師進行的檢查有著巨大的影響力,因為婦產科醫師會將高風險病患轉診給他們。
So in general, this is important in health systems where those OBs and MFMs work very closely, but it is even actually important outside of the health system context, where an MFM can go to the OBs who are referring their patients to them and say that, I would rather -- you know, if they are a big advocate of UNITY, they can say that, you know, I would rather have you use UNITY for your frontline screen in that way when I get these high risk patients, I have all the information that I need to be able to counsel them, to be able to manage them, to be able to treat them.
所以總的來說,這在婦產科醫生和母胎醫學專家密切合作的醫療系統中非常重要,但即使在醫療系統之外,這也很重要。母胎醫學專家可以去找那些將病人轉診給他們的婦產科醫生,說:“我更希望——你知道,如果他們大力倡導 UNITY 篩檢,他們就可以說,‘我更希望你們使用 UNITY 進行一線篩檢,這樣,當我遇到這些高危病人時,我就擁有了所有必要的信息,可以為他們提供諮詢、管理和治療。’”
Operator
Operator
Dan Arias, Stifel.
Dan Arias,Stifel。
Daniel Arias - Analyst
Daniel Arias - Analyst
Afternoon, guys. Thanks for the questions. Oguzhan, can you maybe talk about the new provider increased number that you mentioned for Northstar? How should we think about that as a metric? What would you consider good versus not good this year when it comes to bringing new docs on board? Just sort of be helpful to understand how you're expanding usage in the market.
下午好,各位。謝謝大家的提問。Oguzhan,您能否談談您之前提到的 Northstar 新供應商增加的數量?我們應該如何將其視為一項衡量標準?今年在引進新醫師方面,您認為怎樣的做法才算好,怎樣的做法才算不好?了解你們如何在市場上擴大使用範圍,這會很有幫助。
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Thank you, Dan. The number that I referred to was combined across prenatal and oncology. So when we looked at the number of ordering providers -- active ordering providers that we have in every quarter, what we have seen in Q4 is that number of active ordering providers actually significantly increased. That was the best quarter in terms of active ordering providers that we have been able to add.
謝謝你,丹。我提到的這個數字是產前和腫瘤科的總和。因此,當我們查看每個季度活躍訂購提供者的數量時,我們發現第四季度活躍訂購提供者的數量實際上大幅增加。這是我們迄今為止新增活躍訂購商數量最多的季度。
What that usually means is very strong growth for Q1. As we previously mentioned, because Q4 is fewer number of accessioning days, the true impact on the test volume growth is usually not reflected in the Q4 numbers. But if you look at the number of active ordering providers, and we actually have a high bar for calling a provider, an active ordering provider, if they order just one or two tests, that doesn't count.
這通常意味著第一季將實現非常強勁的成長。正如我們之前提到的,由於第四季度的樣本接收天數較少,因此對檢測量成長的真正影響通常不會反映在第四季度的數據中。但如果你看一下活躍的訂購提供者的數量,你會發現我們對稱提供者為活躍的訂購提供者有著很高的標準,如果他們只訂購了一兩項測試,那就不算數。
So from that perspective, what that comment is really referring to is, compared to all the previous co-authors, Q4 was actually the strongest quarter in terms of having new active providers that are not just dabbling in or using one or two tests, but that are using our products regularly, using the quarter, which means usually a very strong signal for where the Q1 test numbers are going to end up at.
所以從這個角度來看,這條評論真正指的是,與之前所有合作作者相比,第四季度實際上是新增活躍供應商數量最多的季度,這些供應商不僅涉獵或使用一兩項測試,而且在本季度定期使用我們的產品,這意味著通常可以非常強烈地預示第一季度的測試數量最終會是多少。
Daniel Arias - Analyst
Daniel Arias - Analyst
Okay, okay. And then Ross, Oguzhan made a comment on gross margins. Is it right to think that the assumption is flat gross margins for the year? And then are you comfortable with that across the guidance range and across the range of mixes that you might see? I mean, I know you can control that mix, but I just want to kind of make sure that that's a fully underwriterable number sort of regardless of scenario.
好的,好的。然後,羅斯,奧古斯漢就毛利率發表了評論。假設全年毛利率不變,這種想法是否正確?那麼,對於指導範圍和您可能遇到的各種混合情況,您是否感到滿意?我的意思是,我知道你可以控制這個比例,但我只是想確保無論在什麼情況下,這都是一個完全可承保的數字。
Ross Taylor - Chief Financial Officer
Ross Taylor - Chief Financial Officer
Yeah, good question, Dan. I think we're not given a whole lot of color around gross margins are some of the expense lines, other than to say we want to operate the business with positive operating income on a GAAP basis going forward. But I would expect the gross margins to stay up in that high 60%-ish range.
嗯,問得好,丹。我認為,除了表示我們希望未來能依照 GAAP 準則實現正營業收入之外,我們對毛利率和一些費用項目並沒有太多了解。但我預計毛利率將維持在 60% 左右的高點。
Maybe we could continue somewhere in this 71%, low-70% range. But I think I would not get aggressive at all in terms of expectations for expansion and gross margin.
或許我們可以繼續維持在 71% 到 70% 左右的範圍內。但我認為,在擴張和毛利率的預期方面,我完全不會抱持過高的期望。
Operator
Operator
Mark Massaro, BTIG.
馬克·馬薩羅,BTIG。
Mark Massaro - Equity Analyst
Mark Massaro - Equity Analyst
Hey guys, congrats on a strong year and certainly a lot to dig into as well. I wanted to ask about the United contract going in network. I presume this is for UNITY, although UNITY is not your only product in the market. So can you just speak to which product the United contract covers? Then, historically in diagnostics, sometimes people negotiate in network. with large health plans and they have to take maybe a price discount. Can you just speak to how we should be thinking about that dynamic, whether or not we should expect slightly lower ASPs as a result of this going in network?
嘿,夥伴們,恭喜你們度過了碩果累累的一年,當然也有很多值得深入研究的內容。我想問一下聯合航空的合約在網路化方面的情況。我猜這是針對 Unity 的,儘管 Unity 並不是你們在市場上唯一的產品。那麼,您能否具體說明聯合航空的合約涵蓋哪些產品?然後,在診斷領域,歷史上有時人們會與大型醫療保險公司進行網路內談判,他們可能不得不接受價格折扣。您能否談談我們應該如何看待這種動態,以及由於網路接入,我們是否應該預期平均售價會略有下降?
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. I think you should expect higher ASPs going forward. We have signed over the course of last four years probably close to 200 contracts and not a single one decreased our ASPs. So from that perspective, when you get in network with a payer, more broadly, what happens is that you do agree to a percentage of Medicare as part of that contract. But that also means that you get reliable reimbursement for that percentage rather than the amount actually going into the coinsurance and deductible of patients.
謝謝你,馬克。我認為未來平均售價應該會上漲。在過去的四年裡,我們可能簽訂了近 200 份合同,但沒有一份合同降低了我們的平均售價。所以從這個角度來看,當你與支付方建立網絡時,更廣泛地說,發生的情況是,你確實同意將一定比例的醫療保險費用作為合約的一部分。但這同時也意味著,您可以獲得該百分比的可靠報銷,而不是實際用於支付患者共同保險和自付額的金額。
So, given the patient collections are not, are never really 100% despite best efforts, what typically happens is that you might agree to a lower percentage, let's say 80%, 70% of Medicare, but that ends up being significantly higher than what you would otherwise get on a blended ASP basis. I can't go into the specifics of a contract due to confidentiality reasons, but what I would say is that we, again, also typically see that for every contract that we sign, it is actually for both all the products that you have is for prenatal and oncology products.
因此,儘管盡了最大努力,但患者款項的收取永遠不可能達到 100%,通常情況下,你可能會同意較低的百分比,例如 Medicare 的 80% 或 70%,但這最終會比你按混合 ASP 計算所得的金額高得多。由於保密原因,我無法透露合約的具體細節,但我可以肯定的是,我們通常也會看到,我們簽署的每一份合約實際上都涵蓋了你們所有的產品,包括產前產品和腫瘤產品。
That doesn't mean that a test, every test, is going to get paid, right? You need to have the coding, you need to have the coverage as well. So you need to have the contract, and contract will cover what codes that you have, but there should also need to be -- there needs to be the coverage for a test to be paid. So from that perspective is a comparable benefit. And again, this is public information that can be found with United Healthcare, including with many of the commercial contracts that we have.
但這並不意味著每次測驗都會獲得報酬,對吧?你需要編寫程式碼,也需要進行程式碼覆蓋。所以你需要一份合同,合約會涵蓋你擁有的程式碼,但還需要——需要有支付測試費用的保障。從這個角度來看,這是一項相當的優勢。再次強調,這些資訊都是公開訊息,可以在聯合健康保險公司(United Healthcare)的資料中找到,包括我們簽訂的許多商業合約中也包含這些資訊。
Mark Massaro - Equity Analyst
Mark Massaro - Equity Analyst
Okay, great. And then maybe as a follow-up, can you just speak to what you might be seeing in the field? I know Natara launched a fetal focus, if you're seeing any impact there. And then if I can ask a cleanup, pharmacogenomics and Northstar Select CH, these are add-on products. Is this a potential source of additional ASP? In other words, will you be charging for these tests?
好的,太好了。然後,作為後續問題,您能否談談您在實地考察中看到的情況?我知道Natara推出了一項以胎兒發育為重點的計劃,如果你看到這方面有任何成效的話。然後,如果我可以要求進行清理、藥物基因組學和 Northstar Select CH,這些都是附加產品。這是否可能成為增加平均售價的潛在來源?換句話說,這些測試會收費嗎?
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
So, the... You know, taking on the oncology question first, the Northstar Select CH and PGx are add-ons to our existing tests. We do not typically expect to see significant ASP lifts coming from such add-ons, especially in the short term.
所以,這…你知道,先來解決腫瘤學問題,Northstar Select CH 和 PGx 是我們現有測試的附加項。我們通常不期望此類附加功能帶來顯著的平均售價提升,尤其是在短期內。
In the long term, as guidelines evolve and, you know, the current guidelines with respect to ESMO for instance, they're already supportive of buffy code sequencing with respect to CH. There can be ASP lifts as these become covered benefits.
從長遠來看,隨著指南的不斷發展,例如,ESMO 目前的指南已經支持對 CH 進行白血球編碼測序。當這些成為健保福利時,平均售價可能會上漲。
With respect to the competition, I think as you can see from the fact that we have added a record number of ordering providers in Q4, our test volume growth numbers in Q4 and the way that our prenatal revenues are increasing, I think it is relatively straightforward to conclude that we are actually not seeing any impact from the competition so far.
關於競爭方面,我認為,正如您從我們第四季度新增創紀錄數量的訂購提供商、第四季度的測試量增長以及產前收入的增長方式所看到的那樣,我認為可以比較容易地得出結論,到目前為止,我們實際上還沒有看到競爭的任何影響。
Operator
Operator
Subbu Nambi, Guggenheim.
蘇布南比,古根漢美術館。
Subbu Nambi - Equity Analyst
Subbu Nambi - Equity Analyst
Hey, guys, thank you for taking my question. This is your second quarter reporting as a public company. As you reflect on these first two quarters, what has gone according to plan so far and what has exceeded your expectation and what could have gone better and is an area of focus for improvement in 2026?
嘿,各位,謝謝你們回答我的問題。這是貴公司作為上市公司發布的第二份季度財報。回顧前兩個季度,哪些方面按計劃進行?哪些方面超出預期?哪些方面可以做得更好,是 2026 年需要重點改善的領域?
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Thank you, Subbu. I think we have been operating similar to this cadence for the last three years. And this is something that our pre-IPO investors would easily attest to. We have reported quarterly results and beat and raise our guidance past three years. In fact, our board members will tell you that we never really missed the guidance in the time that they have been an investor.
謝謝你,Subbu。我認為過去三年我們的運作節奏一直都差不多。這一點,我們IPO前的投資人可以輕易證實。過去三年,我們公佈了季度業績,並均超越預期,同時提高了業績預期。事實上,我們的董事會成員會告訴你,在他們擔任投資人的這段時間裡,我們從未真正錯過任何指導。
So from that perspective, everything has been going according to the plan. That doesn't mean that everything that you work on essentially ends up being -- ends up giving you better results. It is just that we work on a number of drivers and many of those drivers are not embedded into the guidance. So if some of them turn out to be true, that still ends up having an upside to what we originally expected our results to be.
所以從這個角度來看,一切都在照計畫進行。但這並不意味著你所做的每一件事最終都會為你帶來更好的結果。問題在於,我們研究了許多駕駛員,而其中許多駕駛員並沒有納入指導方針中。所以,即使其中一些預測成真,最終的結果仍然會比我們最初預期的結果更好。
In terms of what maybe did not go according to the plan, because perhaps of the timing of the IPO and earnings calls, it has been a lot of conferences and investor meetings and earnings calls. We certainly prefer to focus on running the company and building the business to participating in the conference, no offense intended.
至於哪些方面可能沒有按計劃進行,可能是因為首次公開募股和盈利電話會議的時間安排,期間召開了許多會議、投資者會議和盈利電話會議。我們當然更願意專注於公司營運和業務發展,而不是參加會議,並無冒犯之意。
Subbu Nambi - Equity Analyst
Subbu Nambi - Equity Analyst
Thank you for that. A complete separate follow up, you discussed a bit about some of the upside opportunities for prenatal volumes versus the guidance. But could you discuss what the guidance assumes in terms of prenatal volume growth today and prenatal market share gains? And given the growth you have seen in prenatal volumes, you haven't been impacted by seasonality. But as you think about 2026, do you expect to see more seasonality just because of the volume, the sheer number of volume?
謝謝。另外,您也討論了一些關於產前檢查量相對於指導意見的潛在優勢機會。但您能否談談該指導意見對目前產前業務量成長和產前市場佔有率成長的假設?鑑於產前銷售量的成長,你們並未受到季節性因素的影響。但展望 2026 年,您是否預期會因為交易量、交易量的巨大增長而出現更明顯的季節性現象?
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
You know, we typically see Q4 always being a slower quarter for us, as we previously mentioned. You know, there are a lot of physicians who do not want to switch their tests during Q4. They kind of leave the decision to the beginning of the year. There are also fewer accessioning days in Q4. So the combination of those two factors tend to make our Q4s slower.
你知道,正如我們之前提到的,第四季通常是我們業務較為清淡的季度。你知道,很多醫生都不願意在第四季更換檢測方法。他們通常會把決定留到年初再做。第四季新增入庫天數也較少。因此,這兩個因素結合起來往往會使我們的第四季業績下滑。
So it was actually a sign of particular strength in our business that we did not see a slowdown in Q4. And that I think really bodes extremely well for what we expect Q1 to be and the rest of the year to be. In terms of what our guidance incorporates, it really incorporates essentially our existing number of sales team members and how we expect them to grow.
因此,第四季沒有出現業務放緩,這實際上是我們業務實力特別強勁的一個標誌。我認為這預示著我們對第一季以及今年剩餘時間的預期都將非常樂觀。就我們的指導方針而言,它實際上主要包含了我們現有的銷售團隊成員數量以及我們期望他們如何成長。
on a quarter over quarter basis, essentially what they need to do to maintain and grow each of their territories. It does not include a lot of the upside that can come in from these large health system opportunities, which can be driven by either these guideline changes and the new product additions that we have had, as well as the epic aura integrations that we mentioned, any health system -- or any health system related adoptions are not really incorporated into our guidance.
從季度環比來看,他們基本上需要採取哪些措施來維持和發展各自的區域。它沒有包含大型醫療系統機會帶來的許多好處,這些好處可能源於這些指南的改變和我們新增的產品,以及我們提到的 Epic Aura 集成,但任何醫療系統——或任何與醫療系統相關的採用,都沒有真正納入我們的指南中。
Operator
Operator
David Westenberg, Piper Sandler.
大衛‧韋斯滕伯格,派珀‧桑德勒。
David Westenberg - Analyst
David Westenberg - Analyst
All right. Thanks for taking the question. Congrats on the first couple of great quarters out of the IPO gate. So maybe I missed this because I can't believe no one asked this, but in the last two months, you raised guidance by $15 million at the end point. Can you give us maybe some of the details on what kind of went right over the last two months, what you see different? I I know you have United, maybe that's a contributor. Is that purely the contributor? Anything else to think about there?
好的。感謝您回答這個問題。恭喜公司上市後的前兩季業績都非常出色。也許我錯過了這一點,因為我簡直不敢相信竟然沒有人問過這個問題,但在過去的兩個月裡,你們將最終業績預期提高了 1500 萬美元。您能否詳細介紹一下過去兩個月裡哪些方面進展順利,哪些方面有所不同?我知道你擁有聯合航空的會員資格,這或許是個影響因素。那僅僅是貢獻者的問題嗎?還有其他需要考慮的嗎?
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 incorporate any potential upside that would come from United to our revenues. United contract is effective April 1. Ross had one sentence, I think, in his prepared remarks where he mentioned that compared to the guidance that we had in December, two-thirds of the increase came from the strength in the test volumes and one-third came from higher than expected true up revenue. So it's essentially we came into the December with the idea that Q4s tend to be a little bit seasonally slower for us.
我們沒有將聯合航空可能為我們的收入帶來的任何潛在成長納入考慮。聯合合約將於4月1日生效。我認為,羅斯在事先準備好的發言稿中只說了一句話,他提到與我們 12 月份的預期相比,三分之二的增長來自測試量的強勁增長,三分之一的增長來自高於預期的調整後收入。所以,我們進入 12 月時就認為,第四季對我們來說通常是季節性的淡季。
We had October and November numbers and December ended up being extremely strong with respect to the test volumes, which ended up driving two-thirds of the beat and the one-third came from the fact that we had higher than expected drop revenue in the quarter.
我們有 10 月和 11 月的數據,12 月的測試量非常強勁,最終促成了三分之二的業績超出預期,而剩下的三分之一則來自於該季度高於預期的跌倒收入。
For the new year guidance, we actually did not incorporate any of the developments and the upsides and drivers that we talked about, we essentially took the expectation of on a per test, per sales rep growth in different territories. And then we just incorporated what our quantitative numbers are in Q4. And this is the quantitative result of that model. So we believe that that is why it is very conservative.
對於新年業績指引,我們實際上並沒有納入我們討論過的任何發展、利好因素和驅動因素,我們基本上只是根據不同地區的每次測試、每個銷售代表的增長預期來製定業績指引。然後,我們把第四季的量化數據也納入了考量。這是該模型的量化結果。所以我們認為這就是它非常保守的原因。
David Westenberg - Analyst
David Westenberg - Analyst
Perfect. And then maybe I'm just going to ask in terms of getting paid on response. I mean, how are the conversations going with CMS? There's not many response assays out there. I mean, there's garden response, essentially. How are you anticipating this coverage policy kind of looking like? I know there's different histology types in monitoring. Maybe it kind of looks more like MRD. What are kind of the pushes and pulls that CMS might look at? And I'll take it offline from there and thank you for questions.
完美的。然後我可能會問一下,是否可以按回覆付費。我的意思是,與CMS的溝通進度如何?目前可用的反應檢測方法不多。我的意思是,基本上,花園會做出回應。您預計這項保險會是什麼樣子?我知道監測中有不同的組織學類型。或許它看起來更像MRD。CMS可能會考慮哪些方面的推動因素和拉力因素?接下來我會離線討論,謝謝大家的提問。
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
So, MolDx under its existing policy already covers the concept of treatment monitoring. This policy was written primarily for MRD, but there's a section that actually covers how they think about treatment monitoring and that's a clear line of sight to what we need to provide have started some of those conversations, but of course, it always takes a few back and forth submissions before you get to a coverage decision. So that is why we are still planning for the end of the year for the coverage decision from MolDx for Medicare lives.
因此,MolDx 在其現有政策下已經涵蓋了治療監測的概念。這項政策主要是為 MRD 制定的,但其中一個章節實際上涵蓋了他們如何看待治療監測,這清楚地表明了我們需要提供什麼。我們已經開始進行一些這方面的討論,但當然,在做出核保決定之前,總是需要幾次來回提交。所以,這就是為什麼我們仍在為年底 MolDx 對 Medicare 人群的承保決定做準備的原因。
Operator
Operator
Casey Woodring, JPMorgan.
Casey Woodring,摩根大通。
Casey Woodring - Analyst
Casey Woodring - Analyst
Great. Thank you for fitting me in. Just curious on what you guys are seeing in the therapy selection and response monitoring competitive markets? And if you're bumping into other competitors there of your larger competitors is talking more about response monitoring? And then we'd be curious to hear what's embedded in the guide for oncology volume growth and how that's split across between existing providers versus share gains? And we'd also be curious to hear what the average test order per month is for existing customers of Northstar Select.
偉大的。謝謝你安排我過來。我很好奇各位在治療選擇和反應監測的競爭市場中看到了什麼?如果你遇到其他競爭對手,或者你的大型競爭對手多談論反應監控,那會怎麼樣?然後,我們很想知道腫瘤科業務量成長指南中包含了哪些內容,以及這些內容是如何在現有供應商和市場份額成長之間分配的?我們也很想知道 Northstar Select 現有客戶每月平均測試訂單量是多少。
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
So, can you repeat the first question? I think that was three questions. I want to make sure that I covered everything.
那麼,你能重複第一個問題嗎?我想那是三個問題。我想確保我已經涵蓋了所有內容。
Casey Woodring - Analyst
Casey Woodring - Analyst
Yeah. No, all good. Just on the therapy selection competitive market, if you're bumping into competitors there and on therapy response monitoring as well, given one of your larger competitors is talking more about that test.
是的。沒事,一切都好。僅僅在治療選擇競爭激烈的市場中,如果你遇到了競爭對手,並且在治療反應監測方面也遇到了競爭對手,考慮到你的一個較大的競爭對手正在更多地談論該測試。
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Certainly. I mean, I think it is a clear recognition of that there is a tremendous need for response monitoring. And we are seeing competition, both with therapy selection and response monitoring in the market. With respect to therapy selection, the fact that we are able to most sensitively identify 50%-plus more actionable variants is really a game changer. So for us, it is really about getting in front of the oncologist that tends to be the bottleneck.
當然。我的意思是,我認為這清楚地表明,迫切需要進行響應監測。我們看到市場上在治療選擇和反應監測方面都存在競爭。就治療選擇而言,我們能夠更靈敏地識別出比之前多 50% 以上的可操作變異,這確實改變了遊戲規則。所以對我們來說,真正的瓶頸在於如何與腫瘤科醫師取得聯繫。
And once we are in front of an oncologist, we have peer review publications that show a head-to-head prospective study. But even when a particular oncologist may not think that that particular study would apply to their patient population, 50% more actionable variance is such a large number that they need to just see it for themselves for 5 or 10 patients within their context. So from that perspective, we are able to tell them, you know, why don't we do a research trial with you where you send us, you know, 5 or 10 of your patients for, you know, research purposes where you are running them with standard of care with one of the larger competitors that we have.
一旦我們與腫瘤科醫生會面,我們就可以提供同行評審出版物,這些出版物展示了直接對比的前瞻性研究。即使某位腫瘤科醫師可能認為該項研究不適用於他們的患者群體,但 50% 的可操作差異是一個如此大的數字,他們需要在自己的實際情況下,對 5 到 10 名患者進行觀察。所以從這個角度來看,我們可以告訴他們,為什麼不和你們一起做一項研究試驗呢?你們可以派 5 到 10 位病人做研究,讓他們接受我們某個大型競爭對手的標準治療。
And we are winning those head to head studies and you really need one patient. You know, if one patient's treatment journey changes, because you identified an actionable variant that changed that patient's treatment journey, or that your competitor didn't identify, or they identified the CHIP mutation that we were able to classify as CHIP and say that this patient is not going to respond to this therapy. In both of those cases, just one patient completely changes that physician's view of your test. It only takes one patient that that physician doesn't just become a user of your test, but they become an advocate for your test.
我們在這些直接對比研究中都取得了勝利,而你實際上只需要一個病人。你知道,如果一個患者的治療過程發生了改變,因為你發現了一個可操作的變異,改變了該患者的治療過程,或者你的競爭對手沒有發現這個變異,或者他們發現了我們能夠歸類為 CHIP 的 CHIP 突變,並說這個患者不會對這種療法產生反應。在這兩種情況下,僅僅一個病人就徹底改變了醫生對你檢查結果的看法。只需要一位患者,這位醫生不僅會成為你檢測方法的用戶,還會成為你檢測方法的擁護者。
This is actually where we are seeing a flywheel effect. We initially put a sales rep in a particular region, because there is so much competition, it can take three, six, nine months for them to get in front of oncologists sometimes. It is not just the diagnostics competition. It is all the pharmaceutical sales reps in oncology that are booking lunches, that are taking oncologist's time.
實際上,這就是我們看到的飛輪效應。我們最初會在特定地區安排銷售代表,因為競爭非常激烈,有時可能需要三、六、九個月的時間才能接觸到腫瘤科醫生。這不僅是診斷領域的競爭。都是腫瘤科的醫藥銷售代表在預約午餐,佔用腫瘤科醫師的時間。
But once you have one or two or three physicians who are not just users, but are advocates, they are passionate about what this test does for their patients, they refer -- they advocate for your test to other physicians, which allows you to get in front of them much faster. So one thing that we are seeing is that in territories, as we kind of increase our test volume, it is actually becoming easier and easier because we are able to remove that bottleneck of being in front of oncologists, which is really the only bottleneck against our ability to win against the competition.
但是,一旦你擁有了一兩位或三位醫生,他們不僅是用戶,而且是倡導者,他們對這項測試為患者帶來的益處充滿熱情,他們會推薦——他們會向其他醫生宣傳你的測試,這讓你能夠更快地接觸到他們。因此,我們看到的一點是,隨著我們測試量的增加,在某些地區,情況實際上變得越來越容易,因為我們能夠消除與腫瘤科醫生接觸的瓶頸,而這正是我們戰勝競爭對手的唯一瓶頸。
Casey Woodring - Analyst
Casey Woodring - Analyst
Got it. That's helpful. And then, maybe as just a quick follow up, what's embedded in the guide for oncology volume growth? And how does that split across growth between existing providers and share gains? And we'd also be curious to just hear if you have an average test order per month for existing customers in Northstar Select. That's a question we'll get to now then. Thank you.
知道了。那很有幫助。那麼,或許可以快速追問一下,腫瘤科業務量成長指南包含了哪些內容呢?那麼,這種成長是如何在現有供應商的成長和市佔率提升之間分配的呢?我們也想了解一下,您在 Northstar Select 平台上現有客戶的平均每月測試訂單量是多少。那我們現在就來解答這個問題。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 do not have a number for the average test out select per physician. In terms of the kind of share gains or how we are thinking about the guidance, it is exactly the same way that we think about prenatal. You know, we know that on average, you know, each of our sales reps is able to grow X number of tests per quarter and that allows and you know, we have seen that over the course of last two years, you know, with more than, you know, 40, 45 reps. So we essentially incorporate that growth into our test volume increase for oncology for 2020.
我沒有每位醫生平均選擇的測試數量數據。就份額成長的類型或我們對業績指引的思考而言,這與我們對產前業務的思考方式完全相同。你知道,我們知道平均而言,我們每個銷售代表每個季度都能增加 X 個測試,這使得,你知道,在過去的兩年裡,我們已經看到,有超過 40、45 名銷售代表做到了這一點。因此,我們基本上將這一增長納入了 2020 年腫瘤檢測量的增長計劃中。
Operator
Operator
(Operator Instructions) Brandon, Wells Fargo.
(操作員說明)布蘭登,富國銀行。
Brandon Hines - Analyst
Brandon Hines - Analyst
Thanks. Good afternoon. Ross, in terms of the guide, do we need to get about the ASP growing from the baseline of $560 million in the fourth quarter? And are you assuming any true up revenue tailwind? going forward in the revenue guide?
謝謝。午安.羅斯,就業績指引而言,我們是否需要將第四季的平均售價從 5.6 億美元的基準水準提高?您是否預期會有實際的營收成長利好因素?未來收入指南會如何安排?
Ross Taylor - Chief Financial Officer
Ross Taylor - Chief Financial Officer
Good question, Brandon. The revenue guide does not include any true up revenue, so that's exclusive of true up revenue. And I think as you think about our overall ASP, do remember that the way we computed historically, we do include the true up revenues. You may want to make some adjustments or make assumptions around that.
問得好,布蘭登。收入指南不包含任何調整後的收入,因此該數據不包含調整後的收入。而且我認為,在考慮我們的整體平均售價時,請記住,我們過去計算的方式是,我們確實包含了調整後的收入。你可能需要對此進行一些調整或做出一些假設。
Brandon Hines - Analyst
Brandon Hines - Analyst
Okay, then you just talked about the sales force expansion plans for 20 days. I mean, you've been growing at a pretty rateable pace, both in oncology, you know, call it eight, nine, 10 reps a quarter and prenatal. Are you expecting to accelerate that at all or make any adjustments in response to the competition or some of the new products that you're obviously excited about? Thanks.
好的,那你剛才就講了20天的銷售團隊擴張計畫。我的意思是,你的進步速度相當可觀,無論是在腫瘤學領域(例如每季做 8、9、10 次重複練習)還是在產前醫學領域。您是否計劃加快這一進程,或者根據競爭對手的情況或您顯然很感興趣的一些新產品做出任何調整?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. Thank you, Brandon. You know, as we shared in the earnings deck, you we expect to maintain our growth for prenatal oncology. know, prenatal is slated to grow from 150 roughly to 185 reps by the end of the year. And oncology is expected to grow around from 45 reps to 65 reps by the end of the year. This level of growth is actually chosen not because we cannot grow faster. We certainly can, but this is the kind of maximum level of growth that we feel comfortable about in terms of maintaining the quality of our tests.
謝謝。謝謝你,布蘭登。正如我們在財報中提到的,我們預計產前腫瘤業務將保持成長。產前腫瘤業務的銷售代表人數預計將在年底前從約 150 人增加到 185 人。預計到今年年底,腫瘤科的代表人數將從 45 人增加到 65 人。我們之所以選擇這種成長速度,並不是因為我們無法成長得更快。我們當然可以做到,但就維持測試品質而言,我們認為這種成長幅度已經是極限了。
You can have the most amazing oncology test, but if your test volume is increasing more than 100% year over year, it becomes actually very difficult to maintain the same turnaround time, the same quality of service with those steps.
即使你擁有最先進的腫瘤檢測技術,但如果你的檢測量每年增長超過 100%,那麼要保持同樣的周轉時間和同樣的服務品質實際上會變得非常困難。
So we essentially are doing this very systematic growth also because this allows us to have a level of growth that we believe is going to allow us to maintain the same level of service. even if you have a great test, if your turnaround time goes from 5 days to 15 days, you are going to lose customers, especially for these very time sensitive important tests.
所以,我們基本上是在進行這種非常系統化的成長,因為這樣可以讓我們保持既有的成長水平,又能維持現有的服務水準。即使你的測試做得很好,但如果週轉時間從5天延長到15天,你就會失去客戶,尤其是對於那些對時間要求非常高的重要測試而言。
So from that perspective, our sales team growth numbers is set up in such a way that it will enable us to have excellent end-to-end service, all the way from client services to lab operations to everything that we do. And in that way, it also is done in such a way that prenatal growth balances some of the oncology growth with respect to the GAAP profitability.
因此從這個角度來看,我們的銷售團隊成長目標設定得如此之高,以至於我們能夠提供卓越的端到端服務,涵蓋從客戶服務到實驗室運營,以及我們所做的每一件事。這樣一來,產前成長也能在一定程度上平衡腫瘤學成長,進而達到 GAAP 獲利能力。
Operator
Operator
Tycho Peterson, Jefferies.
泰科·彼得森,傑富瑞集團。
Unidentified Participant
Unidentified Participant
Hey, this is Noah on for Tycho. Thanks for taking our questions here. You wanted to start by asking about the health systems opportUNITY, particularly if you could provide any context on how you're sizing it and then what the timeline looks like for this to possibly show up in numbers.
大家好,我是諾亞,為您帶來泰科的報道。感謝您回答我們的問題。你想先詢問一下醫療系統方面的機遇,特別是能否提供一些關於如何評估其規模的背景信息,以及這項機遇何時才能體現在實際數字上的時間表。
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Thank you. The way that we think about the health system opportunities that each health system can be really anywhere between 10,000 to 30,000 tests per year. And so these are really large health systems that take time, that take multiple stakeholders to be on the same page. And we do have a number of health systems where we have clinical buy-in, but we still need to get integrated with EMR before they can roll out our test as their frontline screening of choice.
謝謝。我們認為,每個醫療系統每年實際可進行的檢測次數可能在 10,000 到 30,000 次之間。因此,這些都是非常龐大的醫療系統,需要時間,需要多個利害關係人達成共識。我們確實與一些醫療系統建立了臨床合作關係,但我們仍需與電子病歷系統進行整合,才能將我們的檢測作為首選的第一線篩檢方法推廣應用。
Given that this is not completely under our control, right, this is -- we first need to integrate with Epic and then we need to integrate with each health system and that can take time, we haven't incorporated any of these. uplifts into our test numbers for 2026. That said, given what we are seeing here, I think especially in the second half of the year, there can be opportunities for one, two, three of these health systems to start coming in.
鑑於這並非完全由我們掌控,對吧?首先我們需要與Epic系統集成,然後我們需要與每個醫療系統集成,這可能需要時間,我們尚未將這些因素納入我們2026年的測試數據中。也就是說,鑑於我們目前所看到的情況,我認為尤其是在下半年,可能會有一到三個醫療系統有機會進入這個市場。
Of course, for 2026, you are not going to see that full impact of 10,000 to 30,000 tests if they come in in the middle of the year. But as we look at 2027, those adoptions, those wins will set us up for another extremely strong year of growth.
當然,如果 10,000 到 30,000 次檢測在 2026 年年中才開始進行,那麼你肯定看不到這 10,000 到 30,000 次檢測的全部影響。但展望 2027 年,這些採用和取得的成功將為我們帶來另一個強勁成長的年份奠定基礎。
Unidentified Participant
Unidentified Participant
Thanks, that's helpful color. And then for my follow up, I just wanted to dive into the guidance a bit more. So for one queue, should we expect any potential disruptions from weather impacts? And then on the OpEx side, is there any phasing to consider throughout the year in terms of spending on MRD trials or incremental hires ahead of the launch? Thanks.
謝謝,這個顏色很有幫助。然後,在我的後續問題中,我想更深入地探討指導原則。那麼,對於一條排隊路線,我們是否應該預料到天氣會對路線造成任何潛在的干擾?那麼在營運支出方面,在產品上市前的 MRD 試驗支出或增量招募方面,是否需要考慮全年的分階段支出?謝謝。
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
Oguzhan Atay - Chairman of the Board, Chief Executive Officer, Co-Founder
In terms of weather impact, you should not expect anything because our Q1 -- with Q4 setting up Q1 very nicely, we expect to have a strong '26, including Q1. In terms of any impact on OpEx, we are continuing to invest at a pace that would continue to make us GAAP profitable. So we do not anticipate any kind of either front loading or end loading of OpEx. It is a very balanced plan, not just actually for this year, but across the course of next three years.
就天氣影響而言,您不必擔心,因為我們第一季——第四季度為第一季度奠定了良好的基礎,我們預計 2026 年(包括第一季)將表現強勁。就對營運支出的影響而言,我們將繼續以能夠使我們繼續實現GAAP盈利的速度進行投資。因此,我們預計不會出現任何形式的營運支出前期投入或後期投入。這是一個非常均衡的計劃,不僅適用於今年,也適用於未來三年。
Operator
Operator
Thank you. I would now like to turn the conference back to Oguzhan Atay for closing remarks. Sir?
謝謝。現在我謹將會議交還給奧古贊·阿泰,請他作閉幕致詞。先生?
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. We had a really strong 2025, but we are even more looking forward to what we will achieve in 2026. Have a good day.
謝謝接線生。感謝各位參加今天的電話會議。我們期待在幾個月後的下次電話會議上與您交流。我們在 2025 年取得了非常優異的成績,但我們更加期待在 2026 年取得更大的成就。祝你有美好的一天。
Operator
Operator
This concludes today's conference call. Thank you for participating. You may now disconnect.
今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。