Personalis Inc (PSNL) 2025 Q1 法說會逐字稿

完整原文

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

  • Operator

    Operator

  • Greetings. Welcome to the Personalis Inc first quarter 2025 earnings conference call.

    問候。歡迎參加 Personalis Inc 2025 年第一季財報電話會議。

  • (Operator Instructions)

    (操作員指示)

  • I would now return the call over to Caroline Corner. Please go ahead.

    我現在要把電話回撥給卡洛琳·科納。請繼續。

  • Caroline Corner - Investor Relations

    Caroline Corner - Investor Relations

  • Thank you, operator.

    謝謝您,接線生。

  • Welcome to Personalis Inc first quarter 2025 earnings call. Joining today's call are Chris Hall, Chief Executive Officer and President; Aaron Tachibana, Chief Financial and Chief Operating Officer, and Richard Chen, Chief Medical Officer and EVP R&D.

    歡迎參加 Personalis Inc 2025 年第一季財報電話會議。參加今天電話會議的有執行長兼總裁 Chris Hall、財務長兼營運長 Aaron Tachibana 以及首席醫療官兼研發執行副總裁 Richard Chen。

  • All statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements within the meaning of the US securities laws.

    本次電話會議中所有與歷史事實無關的陳述均應被視為美國證券法所定義的前瞻性陳述。

  • For example, any statements regarding trends and expectations for our financial performance this year and longer term, cash runway and liquidity position. Revenue expectations and timing, reimbursement goals, size and booking of orders, products, services, technology, expansion of clinical volume, future publications, the outcome and timing of reimbursement decisions, expectations for our existing and future collaboration activities, cost expectations, market size, and our market opportunity and business outlook.

    例如,有關我們今年和長期財務表現、現金流量和流動性狀況的趨勢和預期的任何聲明。收入預期和時間、報銷目標、訂單規模和預訂、產品、服務、技術、臨床量的擴大、未來出版物、報銷決策的結果和時間、對我們現有和未來合作活動的預期、成本預期、市場規模以及我們的市場機會和業務前景。

  • These statements are subject to risks and uncertainties that could cause actual results to differ materially from our current expectations. We encourage you to review our most recent filings with the SEC, including the risk factors described in our most recent filings. Personnel undertake no obligation to update these statements, except as required by applicable law.

    這些聲明受風險和不確定性的影響,可能導致實際結果與我們目前的預期有重大差異。我們鼓勵您查看我們最近向美國證券交易委員會提交的文件,包括我們最近文件中描述的風險因素。除非適用法律要求,否則工作人員不承擔更新這些聲明的義務。

  • Our press release with our first quarter of 2025 results is available on our website www.personalis.com under the investors section and includes additional details about our financial results.

    我們的 2025 年第一季業績新聞稿可在我們的網站 www.personalis.com 的投資者部分查閱,其中包含有關我們財務業績的更多詳細資訊。

  • Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website by 5 p.m. Pacific time today. Now I'd like to turn the call over to Chris for his comments on our first quarter.

    我們的網站還提供我們最新的 SEC 文件,我們鼓勵您查看。今天的電話會議錄音將於今天太平洋時間下午 5 點前在我們的網站上發布。現在我想把電話轉給克里斯,請他對我們的第一季發表評論。

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • Thank you, Caroline. Good afternoon, everyone, and thank you for joining us today.

    謝謝你,卡洛琳。大家下午好,感謝大家今天的參與。

  • We had a great first quarter here at Personalis, and I'm excited to update you on our progress. We achieved revenues of over $20 million this quarter and also delivered over 2000 molecular tests.

    Personalis 的第一季表現非常出色,我很高興向大家通報我們的進展。本季我們的收入超過 2000 萬美元,並進行了 2000 多次分子測試。

  • I can't express how proud I am of the entire Personalis team for hitting those milestone numbers. I'm thrilled with our progress and the whole organization is geared up to win an MRD.

    我無法表達我對整個 Personalis 團隊達到這些里程碑數字的自豪感。我對我們的進步感到非常興奮,整個組織都準備好贏得 MRD。

  • Let me back up a bit for those of you knew to our story to explain what we're doing to improve outcomes for cancer patients. Personalis is a leader in the fast growing MRD, or minimal residual disease testing market, which uses a blood draw instead of imaging or invasive biopsies to monitor therapy effectiveness and to detect cancer recurrence.

    讓我為那些了解我們的故事的人稍微回顧一下,解釋一下我們正在採取哪些措施來改善癌症患者的治療效果。Personalis 是快速成長的 MRD(微小殘留疾病檢測)市場的領導者,該市場使用抽血而不是成像或侵入性活檢來監測治療效果和檢測癌症復發。

  • The MRD market is expected to mature into a $20 billion market, and with our ultra-sensitive MRD test next personal, we believe Personalis positioned for success.

    MRD 市場預計將發展成為一個價值 200 億美元的市場,隨著我們超靈敏的 MRD 測試的推出,我們相信 Personalis 將會成功。

  • Our technology is able to detect cancer when there's only about one fragment of tumor DNA circulating in a million DNA fragments in blood. Our tumor profiling platforms and tests are cutting edge. We're able to see more with high sensitivity and as a consequence, our platforms and tests are used by many of the world's top biopharma companies to improve clinical trial results, personalized treatment, empower a new generation of therapies.

    當血液中一百萬個 DNA 片段中只存在一個腫瘤 DNA 片段時,我們的技術就能偵測到癌症。我們的腫瘤分析平台和測試是尖端的。我們能夠以高靈敏度看到更多訊息,因此,我們的平台和測試被許多世界頂級生物製藥公司用於改善臨床試驗結果、個人化治療、支持新一代療法。

  • We're pushing hard this year on our win in MRG strategy, and our first quarter continued the strong momentum established in 2024.

    我們今年正在努力推動 MRG 策略的勝利,第一季我們延續了 2024 年建立的強勁勢頭。

  • Our revenue was $20.6 million in the first quarter and resulted from solid progress across all three sectors of our business. Our biopharma revenue grew to [$13.6 million] driven by strong growth in the use of next personal. Our enterprise VA revenues were also robust, and our clinical diagnostic business had its highest quarterly revenue to date.

    我們第一季的營收為 2,060 萬美元,這得益於我們三個業務部門的穩定成長。由於 Next Personal 使用量的強勁成長,我們的生物製藥收入成長至 [1,360 萬美元]。我們的企業 VA 收入也很強勁,我們的臨床診斷業務創下了迄今為止最高的季度收入。

  • Our cash and cash equivalents at the end of the quarter are $185.7 million which gives us a comfortable runway to drive our growth objectives. We are reiterating our guidance of $80million to $90 million in revenue for 2025, 30% to 40% quarter over quarter growth in molecular results, and achievement of reimbursement at least two indications in 2025.

    本季末我們的現金和現金等價物為 1.857 億美元,這為我們實現成長目標提供了一個舒適的平台。我們重申我們的指導方針:2025 年收入達到 8000 萬至 9000 萬美元,分子結果環比增長 30% 至 40%,並且 2025 年至少實現兩項適應症的報銷。

  • Now, let's dive into the business by outlining progress metrics key to our win in MRD strategy.

    現在,讓我們深入研究業務,概述 MRD 策略成功的關鍵進度指標。

  • First is clinical usage. We are making great strides in driving next personnel into the nation's oncology community. We're following a unique partner centric strategy to commercialize Next personnel by working with Tempest, one of the country's leading labs, leveraging their approximately 200 person sales force to bring our essay to market.

    首先是臨床用途。我們正在大力培養新一代人才進入國家腫瘤學界。我們遵循獨特的以合作夥伴為中心的策略,透過與國內領先的實驗室之一 Tempest 合作,將 Next 人員商業化,利用其約 200 人的銷售團隊將我們的論文推向市場。

  • We delivered 2,184 molecular tests this past quarter, which is an increase of 52% compared with 1,441 molecular tests delivered in the 4th quarter of last year.

    我們在上個季度進行了 2,184 次分子測試,與去年第四季的 1,441 次分子測試相比增加了 52%。

  • Now to underscore this progress further, we've grown our molecular test usage approximately 650% over Q1 of 2024. We believe this performance is very encouraging. Evidence that our winning MRD strategy is working.

    現在,為了進一步強調這項進展,我們的分子測試使用量在 2024 年第一季成長了約 650%。我們認為這個表現非常令人鼓舞。有證據表明我們的成功 MRD 策略正在發揮作用。

  • As physicians order the test on patients and use the results to direct patient care, feedback has been positive, and retention is high. Approximately 40% of our MRD positive results are in the ultra-sensitive range, and our physicians are telling us this is an important differentiator. This allows for a leap forward and earlier detection of cancer recurrence, more discrimination and monitoring therapy, and importantly, the ability to have more confidence in a negative MRD result.

    當醫生要求患者進行測試並使用結果來指導患者護理時,回饋是積極的,並且保留率很高。我們的 MRD 陽性結果中約有 40% 處於超敏感範圍內,我們的醫生告訴我們這是一個重要的區別因素。這使得癌症復發的檢測向前邁進了一大步,對治療進行了更多的鑑別和監測,更重要的是,對陰性 MRD 結果更有信心。

  • We believe that our win in MRD strategy will be powered by combining better data with a strong experience and we're spending time in this phase of our winning MRD strategy on being best in class. In terms of customer care and a robust experience.

    我們相信,我們的 MRD 策略的成功將得益於將更好的數據與豐富的經驗相結合,並且我們正在花時間在這一階段的 MRD 戰略勝利中成為同類最佳。在客戶服務和豐富的體驗方面。

  • The second dimension of our strategy is deepening clinical evidence and achieving reimbursement. Our early evidence generation is focused on three indications breast cancer, lung cancer, and IO therapy monitoring.

    我們的策略的第二個維度是深化臨床證據並實現報銷。我們早期的證據生成主要集中在三種適應症:乳癌、肺癌和IO治療監測。

  • We've previously summarized the findings from investigators at Royal Marsden for breast cancer, for IO therapy monitoring, and TRACERx for lung cancer. These 3 indications and their results are powering 3 different Medicare submissions.

    我們先前已經總結了皇家馬斯登醫院研究人員對乳癌、IO 治療監測以及肺癌 TRACERx 的研究結果。這 3 種適應症及其結果為 3 種不同的 Medicare 申請提供支援。

  • In March, the Royal Marston paper was published, and we submitted to Medicare for breast cancer reimbursement. When the VHIO and TRACERx papers are accepted for publication, we plan to submit for Medicare for reimbursement for immunotherapy monitoring and lung cancer, respectively.

    三月份,皇家馬斯頓的論文發表了,我們向醫療保險提交了乳癌報銷申請。當 VHIO 和 TRACERx 論文被接受發表時,我們計劃分別提交給 Medicare 以獲得免疫療法監測和肺癌的報銷。

  • We continue to be confident that we will achieve reimbursement at least 2 of the indications in 2025, and I look forward to updating you as the year progresses.

    我們仍然有信心在 2025 年實現至少 2 項適應症的報銷,我期待在今年向您通報最新進展。

  • We were excited this quarter to unveil our first data in colorectal cancer, or CRC. Now this indication is important within the oncology community, as the lion's share of MRD clinical data and significant reimbursement to date has been developed in this indication.

    本季我們很高興公佈了首批大腸直腸癌(CRC)數據。現在,這種適應症在腫瘤學界非常重要,因為迄今為止,大部分 MRD 臨床數據和大量報銷都是在這一適應症中開發的。

  • Our work is in response to feedback from physicians that there is an unmet need for a more sensitive approach in CRC. Now what that means is that doctors want to identify more patients right after surgery that are going to recur because that is a critical time to make treatment decisions.

    我們的工作是為了回應醫生的回饋,即 CRC 中存在一種尚未滿足的更敏感方法的需求。現在這意味著醫生希望在手術後立即識別出更多即將復發的患者,因為這是做出治療決策的關鍵時刻。

  • They also want a test that can spot the cancer even when it recurs in a distant organ such as the lung. And lastly, they tell us they want to be more confident in a negative MRD result. Delivering on these needs will better guide patient management in the post-surgical CRC setting.

    他們還希望進行一項測試,即使癌症在肺部等遠端器官復發,也能發現它。最後,他們告訴我們,他們希望對陰性 MRD 結果更有信心。滿足這些需求將能更好地指導 CRC 術後病患管理。

  • At the AACR meeting this past week in Chicago, our collaborators at British Columbia Cancer showed early analysis from a prospective study called Victory.

    在上週於芝加哥舉行的 AACR 會議上,我們在不列顛哥倫比亞癌症中心的合作者展示了一項名為「勝利」的前瞻性研究的早期分析。

  • The BC Cancer data set presented included 71 patients with a median follow up of 15 months and showed next personnel was able to detect 100% of recurrences prior to imaging. Importantly, 87% of the cancer relapses were detected in the early landmark window of 2 weeks to 8 weeks post-surgery, with the majority of those detections in the ultra-sensitive range.

    所呈現的 BC 癌症資料集包括 71 名患者,平均追蹤時間為 15 個月,並顯示後續人員能夠在成像之前檢測到 100% 的復發。重要的是,87% 的癌症復發是在手術後 2 週至 8 週的早期里程碑窗口期內檢測到的,其中大多數檢測都處於超敏感範圍內。

  • That we unlock with our assay. Additionally, 100% of metastatic relapses were detected by the assay, including all distant lung metastasis. The improved performance from our approach, we believe, could enable a better way to manage CRC patients in the future.

    我們透過分析來解開這個謎。此外,該檢測方法檢測到了 100% 的轉移性復發,包括所有遠端肺轉移。我們相信,我們的方法所取得的改進將使我們能夠在未來更好地管理 CRC 患者。

  • Now during the last call, I discussed how a physician using exper was able to spot a recurrence of breast cancer, and their patient was able to access therapy ahead of imaging and the impact this had on the patient's life.

    在最後一次通話中,我討論了醫生如何使用 exper 發現乳癌復發,以及他們的患者如何在成像之前接受治療以及這對患者生活的影響。

  • Today I'd like to spotlight a patient that has stage 3 colorectal cancer that was diagnosed last summer.

    今天我想重點介紹一位去年夏天被診斷出患有第 3 期結腸直腸癌的患者。

  • His physician treated him with neoadjuvant chemotherapy and then surgically removed the tumor. At that point, the physician had the option to either observe or treat the patient with adjuvant chemotherapy based on clinical guidelines.

    他的醫生對他進行了新輔助化療,然後透過手術切除了腫瘤。此時,醫師可以根據臨床指引選擇觀察患者或採用輔助化療治療患者。

  • To help make that decision, the oncologist ordered the NeXT Personal test approximately 4 weeks after surgery. The test was positive, and it was in the ultra-sensitive range, which suggested that the patient was at a high cancer recurrence risk, prompting the physician to immediately start adjuvant chemotherapy for the patient. The physician then used the NeXT Personal test to monitor response to therapy. Reassuringly, subsequent tests showed clearance of circulating tumor DNA after starting chemotherapy, suggesting a good response for treatment for the patient.

    為了幫助做出這項決定,腫瘤科醫生要求在手術後約 4 週進行 NeXT Personal 測試。檢測結果呈陽性,且處於超敏感範圍,提示患者癌症復發風險較高,醫師要求立即為患者開始輔助化療。然後,醫生使用 NeXT Personal 測試來監測治療反應。令人欣慰的是,後續檢測顯示,開始化療後循環腫瘤 DNA 被清除,顯示患者對治療有良好的反應。

  • It's an example like this where ultra-sensitive tests can positively impact a patient's journey that motivates our work. Now, while the CRC data is preliminary, the results are encouraging and put us on a path to potentially submit for publication over the next year.

    就是這樣一個例子,超靈敏的測試可以對患者的旅程產生積極的影響,從而激勵我們的工作。現在,雖然 CRC 數據是初步的,但結果令人鼓舞,並使我們有可能在明年提交出版。

  • Working to mature the data we'll begin our drive towards reimbursement for our 4th indication, and we expect success in the large CRC market to be a significant driver of revenue in the next few years.

    為了完善數據,我們將開始推動第四種適應症的報銷,我們預計大型 CRC 市場的成功將成為未來幾年收入的重要驅動力。

  • As a reminder, we expect our collaborators within our 1st 3 indications, breast, lung, and IO therapy monitoring to be presenting results in future conferences and these studies to continue to fuel a robust publication's roadmap.

    提醒一下,我們期望我們在前 3 個適應症(乳腺、肺和 IO 治療監測)內的合作者能夠在未來的會議上展示結果,並且這些研究將繼續為強大的出版物路線圖提供動力。

  • In breast cancer, we're working with Vanderbilt, Johns Hopkins, and other institutions on the PREDICT study, which is an approximately 180 patient study in early triple negative breast cancer and HER2 positive breast cancer, and we have an ongoing prospective study called Be Stronger 1 and triple negative breast cancer that's now enrolled approximately 100 patients from approximately 30 sites.

    在乳癌領域,我們正在與范德堡大學、約翰霍普金斯大學和其他機構合作進行 PREDICT 研究,這是一項針對早期三陰性乳癌和 HER2 陽性乳癌的約 180 名患者的研究,我們還有一項正在進行的前瞻性研究,稱為 Be Stronger 1 和三陰性乳癌,目前已從大約 30 個地點招募了約 100 名患者。

  • We also have ongoing studies with Dana Farber on HER2 positive patients, the Institute Curie on an approximately 100 patient early stage triple negative breast cancer, and with MD Anderson.

    我們也與丹娜法伯癌症研究所、居禮研究所以及 MD 安德森癌症中心合作,對 HER2 陽性患者進行研究。

  • In IO therapy monitoring, we're working with UKE in two different melanoma studies with Duke and a study of gastric cancer patients and with UCSD and a pancancer IO therapy study across 8 different cancer types. In early-stage lung cancer, we're continuing our work with the TRACERx team and we're pushing forward on an additional study called Darwin 2.

    在IO治療監測方面,我們正在與UKE合作進行兩項不同的黑色素瘤研究,與杜克大學合作進行一項針對胃癌患者的研究,並與加州大學聖地牙哥分校合作進行一項針對8種不同癌症類型的全癌IO治療研究。在早期肺癌方面,我們正在繼續與 TRACERx 團隊合作,並正在進行一項名為 Darwin 2 的附加研究。

  • As the data from these studies begin to enter the public domain, we expected to highlight the importance of our ultra-sensitive approach to detecting CT DNA and allow physicians to better manage and treat patients with cancer.

    隨著這些研究的數據開始進入公共領域,我們希望強調我們檢測 CT DNA 的超靈敏方法的重要性,並讓醫生更好地管理和治療癌症患者。

  • The third area we are tracking is progress with our biopharma customers.

    我們正在追蹤的第三個領域是我們的生物製藥客戶的進展。

  • The ultra-sensitive approach we are pioneering provides biopharma customers the ability to accelerate clinical trials with greater accuracy and can translate to significant savings for our biopharma customers by getting answers sooner.

    我們率先採用的超靈敏方法使生物製藥客戶能夠以更高的準確度加速臨床試驗,並可以透過​​更快地獲得答案為我們的生物製藥客戶節省大量成本。

  • The past quarter, our revenue from this segment was $13.6 million. This was 39% growth over the first quarter of 2024 and is driven by increasing adoption of our MRD platform both by existing and new biopharma customers.

    上個季度,我們從該部門獲得的收入為 1,360 萬美元。這比 2024 年第一季成長了 39%,這得益於現有和新生物製藥客戶越來越多地採用我們的 MRD 平台。

  • We saw record revenue in MRD and we are tracking to generate year over year growth of 300% to 400% in MRD revenue from biopharma customers.

    我們的 MRD 收入創下了歷史新高,我們預計來自生物製藥客戶的 MRD 收入將年增 300% 至 400%。

  • Importantly, We've landed two large additional customers and expect each of them to generate annual revenue in the $5 million range this year. Those wins are attributed to the decision by those clients to adopt next personal.

    重要的是,我們又獲得了兩個大客戶,預計他們今年的年收入都將達到 500 萬美元左右。這些勝利歸功於這些客戶決定採用下一個人。

  • Our second platform, ImmunoID Next, remains the platform of choice for biopharma companies developing immunotherapies and is also utilized by Moderna in its individualized neo antigen therapy programs. Market demand for ImmunoID remains strong, and we continue efforts to broaden our tumor profiling product portfolio with new versions developed to capture additional business from biopharma that have grown to trust Personalis as a partner.

    我們的第二個平台 ImmunoID Next 仍然是生物製藥公司開發免疫療法的首選平台,並且也被 Moderna 在其個人化新抗原治療計劃中使用。市場對 ImmunoID 的需求仍然強勁,我們將繼續努力擴大我們的腫瘤分析產品組合,開發新版本以獲取已逐漸信任 Personalis 作為合作夥伴的生物製藥公司的更多業務。

  • The year is off to a strong start at Personalis, and we are laser focused on our strategy to win an MRD. Our employees, collaborators, and partners are working hard to improve the journey for cancer patients with an ultra-sensitive MRD approach, and in the process we're creating a special company.

    Personalis 今年開局強勁,我們全神貫注於贏得 MRD 的策略。我們的員工、合作者和合作夥伴正在努力透過超敏感的 MRD 方法改善癌症患者的治療歷程,在此過程中,我們正在創建一家特殊的公司。

  • We're grateful for all of our investors that are part of our journey to pioneer this ultra-sensitive MRD testing market. We're running fast towards multiple milestones in 2025, and it's shaping up to be a significant year for the company as we execute on our growth drivers and most importantly, a significant year for patients with cancer as we redefine the way cancer is managed. With that, I will now turn it over to Aaron to review our financial results.

    我們感謝所有與我們一起開拓超靈敏 MRD 檢測市場的投資者。我們正在快速邁向 2025 年的多個里程碑,對於公司來說,這將是意義非凡的一年,因為我們將執行成長動力;最重要的是,對於癌症患者來說,這將是意義非凡的一年,因為我們將重新定義癌症的治療方式。現在,我將把時間交給 Aaron 來審查我們的財務結果。

  • Aaron Tachibana - Chief Financial Officer, Chief Operating Officer, Senior Vice President

    Aaron Tachibana - Chief Financial Officer, Chief Operating Officer, Senior Vice President

  • Thank you, Chris. I will discuss our first quarter 2025 results and then cover our guidance for the second quarter and the full year.

    謝謝你,克里斯。我將討論我們 2025 年第一季的業績,然後介紹我們對第二季和全年的指導。

  • Total company revenue for the first quarter of 2025 was [$20.6 million,] representing a 6% increase compared with $19.5 million for the same period of the prior year.

    2025 年第一季公司總營收為 [2,060 萬美元],較去年同期的 1,950 萬美元成長 6%。

  • The increase in revenue was driven by higher volume from biopharma customers and the [VAMDP], which more than offset the expected decline in enterprise sales from Natera.

    收入的成長得益於生物製藥客戶和 [VAMDP] 的銷售增加,這超過了 Natera 企業銷售額預期的下降。

  • Biopharma revenue was $13.6 million in the first quarter, representing a 39% increase compared with $9.8 million for the same period of the prior year.

    第一季生物製藥營收為 1,360 萬美元,較去年同期的 980 萬美元成長 39%。

  • The accelerated growth from BioPharma was due to the adoption and ramp up of NeXT Personal with several customers and the higher volume for ImmunoID Next, which is used for Moderna and other biopharma customers.

    BioPharma 的加速成長得益於多家客戶採用和推廣 NeXT Personal,以及 ImmunoID Next 的銷量增加,後者用於 Moderna 和其他生物製藥客戶。

  • An important note about NeXT Personal tests sold to biopharma customers is that we get paid for all tests delivered since we are not subject to reimbursement from insurance companies like with our clinical business.

    關於向生物製藥客戶銷售的 NeXT Personal 測試的一個重要注意事項是,我們會獲得所有測試的報酬,因為我們不像臨床業務那樣需要從保險公司獲得報銷。

  • We are tracking well to deliver year over year biopharma growth of 24% of the midpoint of our biopharma estimate, despite the headwinds from Moderna revenue declining year over year.

    儘管 Moderna 收入逐年下降帶來不利影響,但我們仍保持良好的勢頭,生物製藥業務同比增長率達到我們生物製藥預測中位數的 24%。

  • In addition, we recognize [$0.3 million] of revenue from our clinical tests, NextDX and Next Personal.

    此外,我們也從臨床測試 NextDX 和 Next Personal 中獲得了 [30 萬美元] 的收入。

  • Gross margin was 35% in the first quarter compared with 28.1% for the same period of the prior year.

    第一季毛利率為35%,去年同期為28.1%。

  • The year over year increase of 690 basis points was primarily due to favorable customer mix from the increase in biopharma volume.

    年比成長 690 個基點,主要由於生物製藥產量增加帶來的客戶結構有利。

  • In the first quarter, we saw an impact of approximately 8% points to our gross margin due to unreimbursed clinical test costs.

    第一季度,由於未報銷的臨床測試費用,我們的毛利率下降了約 8%。

  • Excluding those costs, gross margin would have been approximately 43% and highlights our ability to expand margins further once we obtained reimbursement coverage and achieve scale.

    除去這些成本,毛利率約為 43%,這凸顯了我們一旦獲得報銷範圍並實現規模化,就有能力進一步擴大利潤率。

  • Operating expenses were $24.9 million in the first quarter compared with $24.4 million for the same period of the prior year. Most of the year over year increase was attributed to selling expenses related to our clinical test volume growth.

    第一季營運費用為 2,490 萬美元,而去年同期為 2,440 萬美元。年比成長的大部分原因是與臨床測試量成長相關的銷售費用。

  • The first quarter R&D expense was $12.6 million compared to $12.8 million for the same period of the prior year, and SG&A expense was$ 12.3 million compared with $11.6 million for the same period of the prior year.

    第一季研發費用為 1,260 萬美元,去年同期為 1,280 萬美元;銷售、一般及行政費用為 1,230 萬美元,去年同期為 1,160 萬美元。

  • Net loss for the first quarter was $15.8 million compared with $13 million for the same period as the prior year. The prior year's net loss included a $4.6 million gain related to the warrants issued to Tempest and were outstanding as of the first quarter of the prior year.

    第一季淨虧損為 1,580 萬美元,而去年同期淨虧損為 1,300 萬美元。上一年度的淨虧損包括與發行給 Tempest 的認股權證相關的 460 萬美元收益,截至去年第一季尚未到期。

  • Excluding the non-cash gain, the prior year net loss would have been $17.6 million for comparative purposes.

    除去非現金收益,去年同期的淨虧損為 1,760 萬美元。

  • Now onto the balance sheet. We finished the first quarter with a strong balance sheet with cash and short-term investments of $185.7 million. During the quarter, we raised approximately $17.8 million net of fees selling common stock at an average price of [$5.89] using at the market offering or ATM that is in place. The cash usage for the first quarter was $20.5 million.

    現在來看資產負債表。我們第一季的資產負債表表現強勁,現金和短期投資總額達 1.857 億美元。在本季度,我們透過市場發行或現有的 ATM 以平均 [5.89 美元] 的價格出售普通股,扣除費用後籌集了約 1,780 萬美元。第一季的現金使用量為2050萬美元。

  • We continue to operate cost effectively and as mentioned during our last conference call, we expect cash usage for the full year of 2025 to increase by approximately $30 million compared with the amount used in 2024, primarily to invest in clinical test volumes in advance of reimbursement, expanding clinical evidence for next personnel by conducting new studies, and adding to our clinical sales team.

    我們將繼續以成本效益的方式運營,正如我們在上次電話會議中提到的那樣,我們預計 2025 年全年的現金使用量將比 2024 年增加約 3000 萬美元,主要用於在報銷之前投資臨床測試量,通過開展新研究為下一批人員擴大臨床證據,並擴充我們的臨床銷售團隊。

  • We expect these investments to help drive NeXT Personal revenue growth post reimbursement later this year and into 2026.

    我們預計這些投資將有助於推動 NeXT Personal 在今年稍後以及 2026 年報銷後的營收成長。

  • Now I'd like to turn to guidance.

    現在我想談談指導。

  • For the second quarter of 2025, we expect total company revenue in the range of $19.5million to $20.5 million.

    對於 2025 年第二季度,我們預計公司總營收將在 1,950 萬美元至 2,050 萬美元之間。

  • Revenue from pharma tests and services and all other customers in the range of $13million to $14 million.

    來自製藥測試和服務以及所有其他客戶的收入在 1300 萬美元至 1400 萬美元之間。

  • And revenue from population sequencing plus enterprise customers of approximately $6.5 million.

    來自人口定序和企業客戶的收入約為 650 萬美元。

  • And for the full year of 2025, our revenue guidance remains the same, and we expect total company revenue in the range of $80million to $90 million. This range encompasses the variability of reimbursement timing and prices.

    對於 2025 年全年,我們的收入預期保持不變,預計公司總收入將在 8,000 萬美元至 9,000 萬美元之間。此範圍包括報銷時間和價格的變化。

  • Revenue from pharma tests and services and all other customers in the range of $62million to $64 million. Population sequencing plus enterprise customers in the range of $15million to 16 million.

    來自製藥測試和服務以及所有其他客戶的收入在 6,200 萬美元至 6,400 萬美元之間。人口定序加企業客戶的範圍在 1500 萬美元到 1600 萬美元之間。

  • Clinical revenue in the range of $3million to $10 million.

    臨床收入在 300 萬美元至 1000 萬美元之間。

  • Gross margin in the range of 22% to 24%, which increased from our prior range of 21% to 23%.

    毛利率在 22% 至 24% 之間,高於先前的 21% 至 23% 範圍。

  • Our gross margin guidance for the full year is expected to be lower than the 32% for the full year of 2024 due to the impact of investing in clinical test volume ahead of reimbursement.

    由於在報銷之前投資臨床試驗量的影響,我們預計全年毛利率指引將低於 2024 年全年的 32%。

  • That loss of approximately $83 million which decreased from $85 million last quarter and includes approximately $20 million of unreimbursed test costs.

    該損失約為 8,300 萬美元,低於上一季的 8,500 萬美元,其中包括約 2,000 萬美元的未報銷測試費用。

  • And cash usage of approximately $75 million, which decreased from the prior range of $75million to $80 million.

    現金使用量約為 7,500 萬美元,從先前的 7,500 萬美元降至 8,000 萬美元。

  • The majority of the increase in cash usage compared with the full year of 2024 is for investing in clinical test volume, clinical studies, and commercial capabilities for ramping up our clinical test volume before and after reimbursement.

    與 2024 年全年相比,現金使用量的增加大部分用於投資臨床測試量、臨床研究以及商業能力,以在報銷前後提高我們的臨床測試量。

  • We look forward to updating you on our progress during the next conference call in a few months, and with that, I will turn the call back over to the operator to begin the Q&A session.

    我們期待在幾個月後的下次電話會議中向您通報我們的進展情況,然後我將把電話轉回給接線員開始問答環節。

  • Operator

    Operator

  • Thank you. We will now be conducting a question-and-answer session.

    謝謝。我們現在將進行問答環節。

  • (Operator Instructions)

    (操作員指示)

  • Operator

    Operator

  • Thomas Flaten, Lake Street Capital Markets, LLC.

    Thomas Flaten,湖街資本市場股份有限公司。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • Hey, good afternoon, guys. Thanks for taking the questions. Hey Chris, assuming the breast cancer reimbursement comes through this year, will you, and if so, how steer the commercial organization towards breast cancer patients in order to maximize the reimbursable volume that you do?

    嘿,大家下午好。感謝您回答這些問題。嘿,克里斯,假設乳癌報銷政策今年能夠通過,你會怎麼做?如果可以的話,你如何引導商業組織面向乳癌患者,以最大限度地提高可報銷金額?

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • Yeah, thanks. Great, good question. Good to hear from you. Yeah, so we've already focused our efforts right now on breast cancer, lung cancer, and IO therapy monitoring, in particular, breast and lung with our own field force, we focused on that, and that's we've accomplished that by pushing into doctors that we think through targeting efforts tend to.

    是的,謝謝。很好,好問題。很高興收到你的來信。是的,所以我們現在已經將精力集中在乳癌、肺癌和 IO 治療監測上,特別是乳癌和肺癌,我們擁有自己的現場力量,我們專注於此,並且我們已經透過推動我們認為透過有針對性的努力可以實現的醫生來實現這一目標。

  • Focus more on breast cancer patients. Oncologists tend to treat a little bit of both, but there's certainly some concentrations, and we've already started that effort when we've got clear line of sight for reimbursement, we've always said that we plan to go faster. We plan to both add in more reps ourselves, and we expect tempest to go faster, but we're targeting into that group of physicians now and have been doing that and doing the same with lung cancer ever since we started the journey and started with those indications.

    更加關注乳癌患者。腫瘤學家傾向於對兩種疾病都進行治療,但肯定存在一些集中治療的情況,我們已經開始了這項工作,當我們獲得明確的報銷前景時,我們一直說我們計劃加快速度。我們計劃自己增加更多的代表,並且我們預計 Tempest 會發展得更快,但現在我們瞄準的是那群醫生,並且自從我們開始旅程並開始研究這些適應症以來,我們一直在這樣做,並且在肺癌方面也做同樣的事情。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • And anything you can share with respect to the doctors that have been ordering, of the 2,100 that you did this past quarter, how many of those were from, doctors that have previously used it? Is it all new docs? Just any kind of color on the docs would be great.

    您能否分享一下有關已訂購藥物的醫生的情況?在上個季度您訂購的 2,100 份藥物中,有多少份來自以前使用過該藥物的醫生?都是新文件嗎?文件上的任何顏色都可以。

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • The retention's been really high. I've been surprised once we get people going and we get them going in mass, they've been staying with us, which is great. We've seen really great top line growth, and we're not breaking out quarter over quarter new and current and physicians, etc.

    保留率確實很高。令我驚訝的是,一旦我們讓人們行動起來,並讓他們大規模地行動起來,他們就會一直和我們在一起,這很好。我們看到了非常出色的營收成長,但我們並沒有逐季公佈新增和現有醫生的數量等。

  • But we've got several 100 physicians now ordering. That's been a mix of new and recurring, clearly in a high growth phase where especially Tempest's field force is out calling on and talking to physicians, that's driving top line growth in terms of new physicians.

    但現在已經有幾百名醫生下訂單了。這是新客戶和重複客戶的混合體,顯然正處於高成長階段,尤其是 Tempest 的現場團隊正在外出拜訪和與醫生交談,這推動了新醫生方面的收入成長。

  • But it's been good. And of course, the dynamic that we see, which is great with the MRD market, is that there's a large number of subsequent samples that start to come in too from patients. So, the reorders as time passes and physicians are checking patients start to click in and we've been really pleased with the progress on that also.

    但一切都很好。當然,我們看到的動態是,MRD 市場呈現良好勢頭,即開始從患者那裡獲取大量後續樣本。因此,隨著時間的推移和醫生對患者的檢查,重新排序開始生效,我們對這方面的進展感到非常滿意。

  • And then the last leg of our strategy, where we're selling ourselves, Thomas, we integrate the CGP test into the mix. And we've been really gratified that in, more cases than not, well over 50% of the new orders that we get have the CGP appended to them, which means that the physician is choosing to, get the entire baseline suite of products on a cancer patient from personnel is both baselining the MRD and the level of cancer in the blood with the ultrasensitive tests, but also baselining the.

    然後,我們策略的最後一步,也就是我們推銷自己,托馬斯,我們將 CGP 測試整合到組合中。我們真的感到欣慰的是,在大多數情況下,我們收到的新訂單中超過 50% 都附有 CGP,這意味著醫生選擇從工作人員那裡獲得癌症患者的整個基線產品套件,不僅使用超靈敏測試對 MRD 和血液中的癌症水平進行基線測定,而且還對基線進行測定。

  • The genomic profile to be able to pick the pick the therapy from the patient. So we feel like it's the strategy is working the way we expected it to.

    基因組圖譜可以幫助患者選擇合適的治療方法。因此我們覺得該策略正在按照我們預期的方式發揮作用。

  • Thomas Flaten - Analyst

    Thomas Flaten - Analyst

  • Thanks.

    謝謝。

  • Operator

    Operator

  • Bill Bonello, Craig-Hallum.

    比爾·博尼洛、克雷格·哈勒姆。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Hey guys, congratulations on a good quarter. A couple of follow up questions if I can.

    嘿夥計們,恭喜你們本季取得了好成績。如果可以的話,我想問幾個後續問題。

  • The first, I guess just to continue on the theme of the strong sequential growth in the MRD volume. Can you give us, I know this is highly subjective, but can you give us some sense of sort of, I don't know how you want to think about it, but what gear you're driving in maybe, I mean, we're seeing really big growth, but I have to imagine without reimbursement, neither you nor Tempest are just sort of.

    首先,我想繼續討論 MRD 量連續強勁成長這個主題。你能給我們,我知道這非常主觀,但是你能給我們一些感覺,我不知道你想怎麼想,但是你可能在駕駛什麼,我的意思是,我們看到了非常大的增長,但我不得不想像,如果沒有報銷,你和 Tempest 都不會只是這樣。

  • Pedal to the metal on trying to get new customers and whatnot. So how do we kind of think about, the growth and the marketing efforts today compared to what they might look like post reimbursement?

    全力以赴地爭取新客戶等等。那麼,與報銷後的情況相比,我們該如何看待當前的成長和行銷工作呢?

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • Yeah, I mean, I think we're metering it though, so we could certainly, push faster with Tempest, and the and the biggest lever we have is to put more people on the on the street ourselves. We currently have the same number of reps that we had as we started the 4th quarter, which I actually maybe even as we started the 3rd quarter, which is just 3-4 people in the field calling on physicians, and that's, been working with a group of physicians that we had ourselves in complementing Tempest and.

    是的,我的意思是,我認為我們正在對其進行計量,因此我們當然可以透過 Tempest 更快地推動,而我們最大的槓桿就是讓更多的人走上街頭。我們目前的代表人數與第四季度開始時相同,實際上可能與第三季度開始時相同,也就是只有 3-4 人在現場拜訪醫生,我們一直在與一組醫生合作,以補充 Tempest。

  • And the and the lever to go significantly faster is to deploy more reps out and but we're metering that right now. We had originally said 30% to 40%. That's how we targeted this the last couple quarters we've, I think exceeded 50%, so growing a little faster than even we had we had planned or had targeted doing internally, which is really which is really great, but we could shift into higher gears if we.

    而顯著加快速度的槓桿是部署更多的代表,但我們現在正在衡量這一點。我們原本說的是30%到40%。這就是我們過去幾個季度的目標,我認為超過了 50%,所以成長速度比我們計劃的或內部設定的目標要快一點,這真的非常棒,但如果我們能夠提高速度,我們就可以進入更高的階段。

  • When we're ready to do that, but we're being careful. I mean, it's always a dance in this business of how fast you run to build the run rate high so that when it flips to reimbursement, you're starting to flip nice revenue growth versus, the, taking the gross margin hit early in the business too, and so we're trying to walk that tightrope the best we can.

    當我們準備好這樣做時,我們會非常小心。我的意思是,在這個行業中,這總是一場舞蹈,看你跑得多快才能提高運行率,這樣當它轉向報銷時,你就會開始實現良好的收入增長,而不是在業務初期承受毛利率的打擊,所以我們正盡力走好這條鋼絲。

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • And then maybe just to get a sense with, how aggressive Tempest is being, I mean if we think of the volume is, I mean, is most of that being generated by your 3 to 4 reps? Is it kind of fifty-fifty? How would we think about that?

    然後也許只是為了了解一下,Tempest 的攻擊性有多強,我的意思是,如果我們考慮一下音量,我的意思是,其中大部分是由你的 3 到 4 次重複產生的嗎?是不是差不多一半一半?我們會怎樣看待這個問題?

  • Aaron Tachibana - Chief Financial Officer, Chief Operating Officer, Senior Vice President

    Aaron Tachibana - Chief Financial Officer, Chief Operating Officer, Senior Vice President

  • Yeah, so hey, this is Aaron, thanks for the question.

    是的,嘿,我是亞倫,謝謝你的提問。

  • So in terms of the volume that's coming in, the way to think about it, so Chris mentioned that our field salesforce remains pretty flat with just a handful of reps. So, what we're seeing is maybe we're not growing new doctors as much, right? It is growing but not as much as what we're going to see on the Tempest.

    因此,就進來的數量而言,思考這個問題的方式是,克里斯提到,我們的現場銷售人員仍然相當平穩,只有少數代表。那麼,我們看到的情況是,我們可能沒有培養出那麼多新醫生,對嗎?它正在增長,但不如我們在 Tempest 上看到的那麼多。

  • But what is growing, the retention rate is very high, and we're seeing the subsequent plasma time points accelerated, right, meaning there's a lot of use going into the, going forward from the subsequent standpoint.

    但正在增長的是,保留率非常高,我們看到後續的血漿時間點加速,對,這意味著從後續的角度來看,未來會有很多用途。

  • On the tempest side, Tempest is starting to go faster and faster because we're headed towards reimbursement, obviously. And what we're seeing there, they are accelerating and bringing in new physicians. The time points or the subsequences are growing as well. So, we're really pleased with how the volume is shaping up. And, like what Chris said, we don't have reimbursement just yet, so we're metering it to a certain level, but we could go faster if we wanted to.

    在暴風雨方面,暴風雨開始變得越來越快,顯然是因為我們正走向報銷。我們看到的是,他們正在加速引進新的醫生。時間點或子序列也在成長。因此,我們對銷售量的成長感到非常滿意。而且,就像克里斯所說的那樣,我們目前還沒有報銷,所以我們正在將其控制在一定水平,但如果我們願意的話,我們可以加快速度。

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • I would underline to Bill, we're also, working collaboratively in places where we can, so, there isn't like a fine line. Between what we're doing and what they're doing but where we can help out, we do, try to make sure the physician gets connected into the system and using the test and certainly there are some cases where we'll self-position and it may be better to be managed to be managed through the tempest architecture so that's whatever works well for the customer because you remember they have all the EMR linkages and all they have all that built as a as an early company we haven't built all that out so we're really just doing whatever makes sense for physicians and for the experience that is home.

    我想向比爾強調的是,我們也在盡可能的地方合作,因此,不存在什麼界線。在我們所做的和他們所做的之間,但在我們可以提供幫助的地方,我們會盡力確保醫生連接到系統並使用測試,當然在某些情況下我們會自我定位,通過 Tempest 架構進行管理可能會更好,所以這對客戶來說是最有效的,因為你記得他們擁有所有的 EMR 架構進行管理可能會更好,所以這對客戶來說是最有效的,因為你記得他們擁有所有的 EMR 鏈接,而且他們已經構建了所有有意義這些,作為一家早期醫生

  • Bill Bonello - Analyst

    Bill Bonello - Analyst

  • Sure, okay, I'll hop back in the queue. Thanks so much.

    當然,好的,我會重新回到隊列中。非常感謝。

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • thanks a lot.

    多謝。

  • Operator

    Operator

  • [Mike Matson would need him and company.]

    [麥克馬森需要他和他的同伴。 ]

  • Unidentified Participant

    Unidentified Participant

  • Hi guys, it's Joseph on from Mike, I guess just maybe on the victory data, it was really great to see that is super strong data. Just a couple of questions around that, I guess the first one just with maybe tempests and then with your own sales force.

    大家好,我是麥克的約瑟夫,我想也許就勝利數據而言,看到如此強大的數據真是太好了。我只想問幾個關於這個的問題,我想第一個問題可能與暴風雨有關,然後與您自己的銷售團隊有關。

  • I know it's a small amount of data and you guys are looking to expand on that, but is this, another indication that you're wanting Tempest to start marketing for? And then, specifically with the data, I was wondering if you could maybe dissect some of the I guess like the patient demographics in the study in the sense of, cancer staging.

    我知道這只是少量的數據,而且你們希望對其進行擴展,但這是否表明你們希望 Tempest 開始進行行銷?然後,具體來說,針對這些數據,我想知道您是否可以從癌症分期的角度剖析研究中患者的人口統計。

  • I'm just trying to understand a little bit more how this compares with, your competitors, and then, I guess maybe also just If you could compare if you have any data on you know this high detection in the early landmark window maybe how that compares to your competitors or what you're hearing from docs in that regard, thanks.

    我只是想進一步了解這與您的競爭對手相比如何,然後,我想也許如果您可以比較一下,如果您有任何數據,您知道在早期里程碑窗口中的這種高檢測率,也許與您的競爭對手相比如何,或者您從文檔中聽到的關於這方面的信息,謝謝。

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • Absolutely. I'll start with the 1st part of the question then Rich can jump in. Rich is with us on this call as usual, so we have I mean this was the beginning of the journey on our 4th indication we think this was, is a big one it's where a lion's share of the early evidence and the MRD usage has been developed and reimbursement is stronger and we think the data looks really good and it's we have incremental value to add it so we're off and running now.

    絕對地。我先從問題的第一部分開始,然後 Rich 可以加入。像往常一樣,Rich 和我們一起參加了這次電話會議,所以,我的意思是,這是我們第四個跡象的開始,我們認為這是一個很大的跡象,其中大部分早期證據和 MRD 用途已經得到開發,報銷也更加強勁,我們認為數據看起來非常好,我們有增量價值可以添加,所以我們現在就開始運行了。

  • This is early, so it's going to take some time for the data to mature and then has to go through the publication and then we'll submit. So, you know it's going to take some time for all this to stitch together but you know as we go along and we're in this for the long haul. We expect this to be a nice driver over time right now as a reminder of the Tempest arrangement is they have exclusivity and breast, lung, and therapy monitoring, and that's where we are, with them from an exclusive standpoint.

    現在還為時過早,所以需要一些時間讓數據成熟,然後必須經過出版,然後我們才會提交。所以,你知道把這一切拼湊起來需要一些時間,但你知道,隨著我們的前進,我們會長期堅持下去。我們預計,隨著時間的推移,這將成為一個很好的驅動力,因為提醒我們,Tempest 的安排是他們擁有獨家經營權以及乳房、肺部和治療監測,而這正是我們從獨家角度與他們合作的地方。

  • Rich, you want to talk about the data and sure you're done with this question.

    里奇,你想談論數據,並且確定你已經回答完這個問題了。

  • Richard Chen - Executive Vice President - Research and Development, Chief Medical Officer

    Richard Chen - Executive Vice President - Research and Development, Chief Medical Officer

  • Yeah, no, it's a great question, and yeah, we're very pleased with the interim results of this prospective study, highly encouraging in colorectal cancer. These are patients that were, stage 1 through 4 resectable, colorectal cancer.

    是的,不,這是一個很好的問題,是的,我們對這項前瞻性研究的中期結果非常滿意,對於大腸癌來說,這是非常令人鼓舞的。這些患者均為第 1 期至 4 期可切除的大腸直腸癌患者。

  • And so, it's a really nice cross section of colorectal cancer across all the different stages, and as you noted, we're very pleased to see really high landmark sensitivity to date in this cohort, 87% were detected, over recurrences were detected in that 2 weeks to 8 week window, which is really nice to see, and compares, very favorably to, what others have reported for landmark.

    因此,這是涵蓋所有不同階段的結腸直腸癌的非常好的橫截面,正如您所說,我們很高興看到迄今為止該群體的標誌敏感性非常高,檢測到了 87% 的複發,在 2 周到 8 週的窗口期內檢測到了復發,這真的很令人高興,並且與其他人報告的標誌敏感性結果相比非常有利。

  • And then the other thing is we detected all the patients, that recurred, prior to imaging.

    另一件事是我們在成像之前檢測了所有復發的患者。

  • So 100% of those patients to date have been detected, and that's also very encouraging.

    因此,迄今為止 100% 的患者都已被檢測,這也非常令人鼓舞。

  • Because, others have demonstrated that, detecting the metastasis, metastatic colorectal can be challenging, at times, and we were able to detect, all the recurrences, including the distant metastasis, in the study, so all in all, we were happy we're going to see those results and we're looking forward to kind of further readouts on this cohort.

    因為其他人已經證明,檢測轉移性結腸直腸癌有時會很有挑戰性,而我們在研究中能夠檢測到所有的複發,包括遠處轉移,所以總而言之,我們很高興看到這些結果,我們期待著對這個群體的進一步解讀。

  • Unidentified Participant

    Unidentified Participant

  • Okay great that's helpful yeah it was really nice data and then maybe just a quick one on NeXT Personal again so just trying to understand ADLT status. I was wondering if you guys just, had an update on your expectation for that, but more specifically just so I can understand, how award how like an award goes about this.

    好的,太好了,這很有幫助,是的,這是非常好的數據,然後可能只是在 NeXT Personal 上再快速了解一下,只是想了解 ADLT 狀態。我想知道你們是否剛剛更新了對此的期望,但更具體地說,只是為了讓我了解,獎項是如何運作的。

  • Would it apply to any indication that you know currently has CMS reimbursement or you know reimbursement that CMS was awarded you guys, or does it need to be applied for each indication?

    它是否適用於您知道目前有 CMS 報銷的任何適應症或您知道 CMS 授予您們的報銷,還是需要針對每種適應症都申請?

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • Yeah, so I mean I think the process is you don't apply or engage with ADLT status until after you've gotten reimbursement so that's the way to, I think that's the way to think about it, but no update there. We've told investors consistently and we'll still reiterate that that we build our economic models assuming we get.

    是的,所以我的意思是,我認為這個過程是,在你獲得報銷之前,你不會申請或參與 ADLT 身份,所以這就是方式,我認為這是思考的方式,但沒有更新。我們一直告訴投資者,並且我們仍將重申,我們建立的經濟模型是基於我們能夠獲得的結果。

  • We were able to get reimbursement that's consistent with what has been in the marketplace. We think there's a couple of dots shots on goal, one of which is that a whole genome sequencing with 1800 variants is a way more sophisticated and resource intensive assay than anything CMS has priced for.

    我們能夠獲得與市場情況一致的補償。我們認為有幾個要點是準確的,其中之一就是,對包含 1800 個變體的全基因組進行測序是一種比 CMS 定價的任何檢測都要複雜和耗費資源的檢測。

  • So we think that that's one way reimbursement could be higher, and we believe that's the easiest shot on goal. We have the best chance. And then secondarily, we think that we're offering something unique and differentiated. And potentially could qualify for ADLT status.

    因此,我們認為這是提高報銷額度的一種方式,而且我們認為這是最容易實現的目標。我們有最好的機會。其次,我們認為我們提供的是獨特且差異化的產品。並且有可能獲得 ADLT 資格。

  • Both of those are upsides. We built the model to thrive if we do not achieve either one of those two drivers. Our COGS are about 40% of the reimbursement, which we think is it puts at a 60% gross margin, and then we've been able to secure with tempest sales and marketing costs down in the 20% to 25% range.

    兩者都有好處。如果這兩個驅動因素中的任何一個都無法實現,我們就會建立蓬勃發展的模式。我們的銷貨成本 (COGS) 約佔報銷金額的 40%,我們認為這將帶來 60% 的毛利率,然後我們能夠確保將銷售和行銷成本降低到 20% 至 25% 的範圍內。

  • And so we think we've got this set up to be really economically compelling for investors even if the reimbursement is based on what had been priced before with a couple of shots on goal, but, because it always I think in this business you want the model to work assuming the worst case reimbursement and then anything above it is [gravy]. You don't want the model to only work. If you get the best case reimbursement, and that's the way we've attacked it, and that's the way we've told people to build their models.

    因此,我們認為,即使報銷是基於先前的定價,並且有幾次射門,我們也已經建立了這個模型,這對投資者來說具有真正的經濟吸引力,但因為我認為在這個行業中,你總是希望模型能夠假設最壞的報銷情況,然後任何高於該情況的報銷都是[肉汁]。您不希望模型僅僅發揮作用。如果您獲得最佳案例報銷,這就是我們處理它的方式,這就是我們告訴人們建立他們的模型的方式。

  • Unidentified Participant

    Unidentified Participant

  • Okay, perfect, congrats on a strong quarter you guys.

    好的,太好了,恭喜你們本季表現強勁。

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • Thanks, I appreciate it.

    謝謝,我很感激。

  • Operator

    Operator

  • Mark Massaro, BTIG LLC.

    BTIG LLC 的 Mark Massaro。

  • Mark Massaro - Analyst

    Mark Massaro - Analyst

  • This is Vivian. Thanks for taking the questions. Maybe just one quick one on the model. Were there anyone-timers in the quarter, just as your decision not to raise the full year guidance? Is that just conservatism given that the range is a bit wider this year, and is there any seasonality dynamics to call out there? Thanks.

    這是薇薇安。感謝您回答這些問題。也許只是模型上的一個快速範例。本季是否有任何意外事件,就像您決定不提高全年業績預期一樣?考慮到今年的範圍有點廣,這是否只是保守主義?是否存在任何季節性動態?謝謝。

  • Aaron Tachibana - Chief Financial Officer, Chief Operating Officer, Senior Vice President

    Aaron Tachibana - Chief Financial Officer, Chief Operating Officer, Senior Vice President

  • Hi Vivian, this is Aaron. No one timers, so to speak. So, in terms of what was in our guide of $17million to $18 million for Q1, most of that beat was coming from biopharma. BioPharma was $13.6 million.

    你好,薇薇安,我是亞倫。可以這麼說,沒有一個計時器。因此,就我們第一季 1700 萬至 1800 萬美元的預期而言,大部分超出預期的銷售額來自生物製藥行業。BioPharma 的銷售額為 1,360 萬美元。

  • [The guide there was $10million to $11 million.]

    [指導價 1000 萬至 1100 萬美元。 ]

  • Incorporated in the guide, we did assume we were going to fulfill the VA contract, the $7.5 million that we had received in September of 2024. That's going to be fulfilled in the first two quarters of 2025, right? So other than that, there's no one timers or anything of that nature. We will call out though as we look forward.

    根據指南,我們確實假設我們將履行 VA 合同,即我們在 2024 年 9 月收到的 750 萬美元。這將在 2025 年前兩個季度實現,對嗎?除此之外,沒有任何計時器或類似的東西。我們會在展望未來時大聲呼喊。

  • We are seeing that a lot of the government trade issues with tariffs and things, it is weighing on the pharmaceutical market. So, we are seeing that a lot of our pharmaceutical partners and customers are, starting to defer certain projects and, even tighten things up or constrict the size of some of them. And so, we're seeing something in the range of $3million to $5 million out in time, from an impact standpoint. We're not changing our guidance. Our guide is still $80million to $90 million because we still have a very, large funnel that continues to build for NeXT Personal with BioPharma customers, right? So, we're still executing well there.

    我們看到,政府在關稅等方面的許多貿易問題給醫藥市場帶來了壓力。因此,我們看到許多製藥合作夥伴和客戶開始推遲某些項目,甚至收緊或縮小某些項目的規模。因此,從影響的角度來看,我們預計最終的損失將在 300 萬至 500 萬美元之間。我們不會改變我們的指導方針。我們的指導金額仍然是 8000 萬到 9000 萬美元,因為我們仍然有一個非常大的漏斗,正在繼續為 NeXT Personal 與 BioPharma 客戶構建,對嗎?所以,我們在那裡的表現仍然很好。

  • Mark Massaro - Analyst

    Mark Massaro - Analyst

  • Thanks for the color there. And then I know there's a prior question on CRC, but, maybe just ask a different way. Could you just discuss the need for a more sensitive MRD tech and CRC? I think in the past you've discussed that next personal, really shines in a lower burden cancer such as breast cancer. But can you just talk about how you feel you're differentiated there? Thanks.

    感謝那裡的色彩。然後我知道 CRC 上有一個先前的問題,但是,也許只需換個方式問。您能否討論一下對更靈敏的 MRD 技術和 CRC 的需求?我認為您過去曾討論過,下一項研究確實在負擔較輕的癌症(例如乳癌)中發揮重要作用。但是您能談談您感覺自己在那裡有何不同嗎?謝謝。

  • Richard Chen - Executive Vice President - Research and Development, Chief Medical Officer

    Richard Chen - Executive Vice President - Research and Development, Chief Medical Officer

  • Yeah, happy to answer that, and it's a great question, in in colorectal cancer, our collaborators and I think other kills in the space have really identified.

    是的,很高興回答這個問題,這是一個很好的問題,在結直腸癌方面,我們的合作者和我認為該領域的其他人已經真正確定了。

  • The that there's a need for sensitivity in that landmark window, and so landmark window is really the first, [2 weeks to 8 weeks, 2 weeks to 10 weeks] after surgery, for colorectal cancer patients, and the reason that window is so important is that's a window when physicians are trying to make a decision about how to manage the patient, the patient's treatment.

    在這個里程碑窗口期內需要有敏感性,因此里程碑窗口期實際上是結腸直腸癌患者手術後的第一個時間 [2 週到 8 週,2 周到 10 週],這個窗口期如此重要的原因在於,醫生在這個窗口期內試圖決定如何管理患者、如何對患者進行治療。

  • And so I think one of the key areas that we demonstrate a really strong performance here, differentiated performance is our sensitivity in that landmark window between 2 weeks and 8 weeks, where we show that we're able to at least to date detect 87% of the patients that eventually recur in that very early window, and so that's, enabled by the fact that we have a highly sensitive test, and so that's I think one way it definitely.

    因此,我認為我們在這裡表現出真正強勁表現的關鍵領域之一,差異化表現是我們在 2 週到 8 週之間的里程碑窗口內的敏感性,我們表明我們至少能夠迄今為止檢測到 87% 的最終在非常早期的窗口內復發的患者,這是因為我們擁有高度敏感的測試,所以我認為這絕對是其中一種方式。

  • The ultra sensitivity matters. I think the other area is in the longitudinal sensitivity, so being able to pick up all the patients before they show up on imaging, as we have in this study, I think it's a Is an indicator of the fact that the sensitivity really does matter there, especially in picking up some of the patients with distant metastasis, which hasn't been easy, in the past, but so far we've been able to pick up all those patients as well, including lung metastasis, that's recognized to be an area where, it can be challenging for ctDNA detection, so.

    超高靈敏度很重要。我認為另一個方面是縱向敏感性,即能夠在所有患者出現在影像學檢查之前就將其識別出來,就像我們在這項研究中所做的那樣,我認為這表明敏感性確實很重要,特別是在識別一些遠處轉移的患者時,這在過去並不容易,但到目前為止,我們已經能夠識別所有這些患者,包括肺轉移,這被認為是 ctDNA 檢測具有挑戰性的領域,所以。

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • No, I would just note that, we started in the breast and lung where the signal is the weakest and it's the one that we could shine the light on the brightest, but what we've really learned from that experience is the patients really also value, the having confidence in the negative MRD results and having ultra sensitivity is key to being able to do that and.

    不,我只想指出,我們從乳房和肺部開始,因為那裡的信號最弱,而我們可以將光照射到最亮的地方,但我們從那次經驗中真正學到的是,患者也確實很看重,對陰性 MRD 結果有信心並且具有超高靈敏度是能夠做到這一點的關鍵。

  • And so we've gotten really great feedback about that because when patients are getting tested, what they're ultimately hoping and praying for is that they're cancer free. Well, there's never guarantees in life, the more sensitivity you have, the more assurance you can have that any single one of those results is solid, and we're seeing that in the data across all the cancers and indications that we're working with.

    因此,我們得到了非常好的回饋,因為當病人接受檢查時,他們最終希望和祈禱的是他們沒有癌症。嗯,生活中從來沒有什麼保證,你越敏感,你就越能確信任何一個結果都是可靠的,我們在研究的所有癌症和適應症的數據中都看到了這一點。

  • Mark Massaro - Analyst

    Mark Massaro - Analyst

  • Thank you so much for taking the question.

    非常感謝您回答這個問題。

  • Operator

    Operator

  • Daniel Brennan, TD Cowen.

    丹尼爾布倫南 (Daniel Brennan),TD Cowen。

  • Daniel Brennan - Analsyt

    Daniel Brennan - Analsyt

  • Great, thanks for the questions. Congrats on the print. Maybe just the first one just on the Mold express filing. Just remind us on the commercialization strategy, just first off, any feedback or any updated thoughts in terms of timing, and then assuming you get a positive opinion, just what happens after that, like how quickly are you ready to go, how do we think about that commercialization push?

    太好了,謝謝你的提問。恭喜列印成功。也許只是第一個只是在模具快遞上歸檔。首先,請提醒我們商業化策略,在時間方面有任何回饋或更新的想法,然後假設你得到正面的意見,那麼之後會發生什麼,例如你多快準備好,我們如何看待商業化推動?

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • Yeah, we will, we're not going to give any updates through the journey just to be, clear, I mean unless we see a reason, to update, but we still feel confident we're tracking ahead of schedule on our internal forecast of where we were and so we feel like we're in a really good position to get two of the three that we're gunning for done this year and all the evidence internally has pointed us in that direction so we're reiterating that and underlining our confidence on where we stand there.

    是的,我們會的,我們不會在整個過程中提供任何更新,只是為了清楚起見,我的意思是,除非我們看到一個更新的理由,但我們仍然有信心,我們提前完成了內部預測,所以我們覺得我們處於一個很好的位置,可以完成今年我們要完成的三個項目中的兩個,而且所有內部證據都指向了那個方向,所以我們重申這一點,並強調我們對目前的信心。

  • Once we get the positive decision, you remember that everything that we will have billed previous to that up until the point of the of the last submission we'll be able to bill. So there'll be a little bit of catch up revenue that we'll be able to get. I think that's usually 60 days typically from one response to the next response. It could be sooner and of course it could lag, but I think their commitment time is. It is roughly 60 days, so there's always that running, and we'll be in a position once we get that, to execute and move and move faster commercially and switch into a higher gear, but there'll be, I think it's more than just breast, it's also getting breast, in another one or getting to going to really start to get critical mass.

    一旦我們得到肯定的決定,請記住,我們將能夠對之前直到最後一次提交之前的所有費用進行計費。因此,我們能夠獲得一點補足收入。我認為從一個回覆到下一個回覆通常需要 60 天。可能更快,當然也可能會滯後,但我認為他們的承諾時間是。大約需要 60 天,所以總是需要時間,一旦我們得到這個時間,我們就可以執行並移動,在商業上更快地移動並切換到更高的檔位,但我認為它不僅僅是乳房,它也是乳房,在另一個或真正開始獲得臨界質量。

  • Right now, we're seeing the cancers that we're seeing come in. Are really scattered across those three indications in a pretty 33 use cases, therapy, monitoring, breast denial in a pretty equal weighted way and so we really want to really want to, to really start to move into higher gear, we want to get a couple of them in the rearview mirror, which is why that's been our goal this year.

    現在,我們看到癌症正在不斷出現。實際上,這三種適應症在 33 種使用案例中都得到了充分的體現,包括治療、監測和乳房拒絕,並且權重相當均等,因此,我們真的想要真正開始進入更高的階段,我們希望從後視鏡中看到其中的幾個,這就是為什麼這是我們今年的目標。

  • Daniel Brennan - Analsyt

    Daniel Brennan - Analsyt

  • Perfect, Chris, thanks. And maybe just on some of the early feedback amongst the doctors to using the test just.

    非常好,克里斯,謝謝。也許只是根據醫生對使用該測試的一些早期回饋。

  • How are they using it, obviously, you've got, the car on the market. Just wondering from the doctors, are they using it complimentary? Are they using it in place of just certain use cases, maybe? I know it's still early, but just wondering kind of, how the doctors are deciding to use your test.

    他們是如何使用它的,顯然,你已經在市場上擁有汽車了。只是好奇醫生們是否免費使用它?他們是否只是用它來代替某些用例?我知道現在還為時過早,但我只是有點好奇,醫生將如何決定使用你的測試。

  • Aaron Tachibana - Chief Financial Officer, Chief Operating Officer, Senior Vice President

    Aaron Tachibana - Chief Financial Officer, Chief Operating Officer, Senior Vice President

  • Yeah, I mean, I think they use.

    是的,我的意思是,我認為他們會使用。

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • It, I mean we're finding that they're using it in place of, I mean, I don't think, I think I'm sure there's some complimentary uses, side by side, but in general, with other approaches, physicians create a baseline and probably stick with one approach, and that's what we're seeing and then we're seeing it used both to check for therapy monitoring.

    我的意思是,我們發現他們用它來代替,我的意思是,我不認為,我認為我確信有一些互補的用途,並行的,但總的來說,對於其他方法,醫生會創建一個基線並可能堅持一種方法,這就是我們所看到的,然後我們看到它同時用於檢查治療監測。

  • So being able to wash the parts per million as you proceed through therapy, no1, 2, look for cancer recurrence, post-treatment, and especially, right after a surgery, in breast and lung, I think are the key use cases that we're seeing.

    因此,在進行治療時能夠洗掉百萬分之幾的量,第 1、2 項是尋找癌症復發、治療後,特別是在乳癌和肺癌手術後,我認為這是我們看到的關鍵用例。

  • Doing that, it's pretty much it.

    做到了這一點,就差不多了。

  • Daniel Brennan - Analsyt

    Daniel Brennan - Analsyt

  • And then maybe just on [ASO,] I know you've got a couple of posters I think you guys have coming out with a couple of studies anything there to point to just kind of walk us through expectations on, forthcoming data.

    然後也許只是在 [ASO] 上,我知道你有幾張海報,我想你們已經提出了一些研究,那裡有什麼可以指出的,只是引導我們了解對即將發布的數據的預期。

  • Richard Chen - Executive Vice President - Research and Development, Chief Medical Officer

    Richard Chen - Executive Vice President - Research and Development, Chief Medical Officer

  • Yeah, there's some oral presentations, maybe the one to, and also posters, maybe the one to make note of is, we have some new adjuvant breast cancer data, that will be talked about with NeXT Personal at ASCO. So, it's not too far away, so hopefully we'll be able to talk about it next time. Yeah.

    是的,有一些口頭報告,也許是一個,還有海報,也許要注意的是,我們有一些新的輔助乳癌數據,將在 ASCO 與 NeXT Personal 討論。所以,這並不是太遠,所以希望我們下次能夠談論它。是的。

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • What's really exciting when you just step back and you look at it all, that I, because we've been at this now and doing these calls is that the data. When you get good results in one data set, you feel good, but you hold your breath and you wait for the second one and you hope it holds. But now we just keep going data set after data set after data set.

    當你退一步看看這一切時,真正令人興奮的是,因為我們現在已經開始這樣做並且進行這些調用,這就是數據。當你在一組數據中獲得良好的結果時,你會感覺很好,但你會屏住呼吸,等待第二個數據,並希望它能保持下去。但現在我們只是不斷地取得一組又一組的資料集。

  • We work with BioPharma and we see the results of those data sets. And so, as time goes on here, I think it's fair to say we're really building confidence in the performance of this assay because it continues to perform well in indication, use case, and data set after data set, indication after indication that And so we feel like we're really starting to pick up steam and adding value.

    我們與 BioPharma 合作並看到了這些數據集的結果。因此,隨著時間的推移,我認為可以說我們確實對這種檢測的性能建立了信心,因為它在指示、用例和一個又一個數據集、一個又一個指示中繼續表現良好,所以我們覺得我們真的開始加速並增加價值。

  • Daniel Brennan - Analsyt

    Daniel Brennan - Analsyt

  • Terrific. Thank you.

    了不起。謝謝。

  • Operator

    Operator

  • Yoko N, Morgan Stanley.

    摩根士丹利的 Yoko N。

  • Yoko N - Analyst

    Yoko N - Analyst

  • Hello, thank you for taking my question.

    您好,感謝您回答我的問題。

  • Given that Victory study seems to suggest earliest and optimal time for blood draw to inform decision on subsequent therapy at 4 weeks, do you think that this timing will be applicable across various tumor types, or could it vary by cancer types?

    鑑於 Victory 研究似乎表明,抽血的最早和最佳時間是在 4 週內,以便決定後續治療,您認為這個時間是否適用於各種腫瘤類型,或者是否會因癌症類型而異?

  • Richard Chen - Executive Vice President - Research and Development, Chief Medical Officer

    Richard Chen - Executive Vice President - Research and Development, Chief Medical Officer

  • Yeah, thanks for your question. It will vary by cancer type, cancer is shed at different rates and different cancer types, so, you really have to look at each cancer type independently, as you look at the data.

    是的,謝謝你的提問。它會因癌症類型的不同而有所差異,癌症脫落的速度和類型也不同,因此,在查看數據時,您必須單獨查看每種癌症類型。

  • Yoko N - Analyst

    Yoko N - Analyst

  • Okay, that was helpful and I appreciate the color and strong traction you're seeing forexer with pharma customers. Could you elaborate on the importance of pharma partnerships to demonstrate clinical utility for NeXT Personal in your development strategy? And also, would you remind me of some of the internal efforts underway?

    好的,這很有幫助,我很欣賞您在製藥客戶中看到的色彩和強大的吸引力。您能否詳細說明製藥合作關係在您的發展策略中對於展示 NeXT Personal 的臨床實用性的重要性?另外,您能提醒我一些正在進行的內部努力嗎?

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • Yeah, so we've been used by most of the top biopharma, you know companies in the world for our next immuno ID platform was used to characterize, samples and build those relationships, and we've been leveraging those relationships with MRD. The use case that we're finding is valuable there, among biopharma customers is first and foremost to get an early answer quickly on a clinical trial.

    是的,世界上大多數頂級生物製藥公司都使用我們的下一代免疫 ID 平台來表徵、採樣和建立這些關係,並且我們一直在利用這些與 MRD 的關係。我們發現,對於生物製藥客戶來說,該用例非常有價值,首先是在臨床試驗中快速獲得早期答案。

  • NeXT Personal can help them fail a trial faster, accelerate a trial. Trial faster and that translates into bottom line dollars quickly.

    NeXT Personal 可以幫助他們更快地失敗審判,加速審判。試驗速度更快,並能迅速轉化為利潤。

  • Secondly, it's helped, we, it's helping them sort the right patients into clinical trials. That would be a sort of a prospective study and picking patients out of the pool that are unlikely to recur, i.e., they're, ctDNA negative and they're unlikely to recur, will enrich the people in the clinical trial and optimize for success.

    其次,它幫助我們,幫助他們將合適的患者篩選到臨床試驗中。這將是一項前瞻性研究,從患者庫中挑選出不太可能復發的患者,即 ctDNA 陰性且不太可能復發的患者,這將豐富臨床試驗中的人員並優化成功率。

  • That's the feedback that we've gotten. And we're working with many of the top people. Last year was really a year of pilots and tests, and then this year we're starting to see the acceleration in revenue. You see that this quarter in the numbers.

    這就是我們得到的回饋。我們正在與許多頂尖人才合作。去年實際上是試點和測試的一年,今年我們開始看到收入的成長。您可以在本季度的數字中看到這一點。

  • And we are, we're working with many of the of the big companies now in the space to help them, get to answers sooner with clinical trials or help them get to more efficacy. We've not been able to announce any big prospective studies with any biopharma companies to date, and we'll obviously keep you posted if we're able to do that, we'll make those announcements.

    我們正在與該領域的許多大公司合作,幫助他們透過臨床試驗更快找到答案,或幫助他們提高療效。到目前為止,我們還沒有宣布與任何生物製藥公司進行任何大型前瞻性研究,如果我們能夠做到這一點,我們當然會及時通知您,我們會發布這些公告。

  • That's where we stand. I think it's part of the clinical evidence piece, but I don't think it's the only piece. I think that we're working with collaborators. We're doing some prospective studies, a lot of retrospective studies, and you're starting to see that, there's a whole new batch at ASCO of studies this year and in AACR with the victory study so we continue to work with ever increasing numbers of collaborators and studies and Biopharma ultimately be a piece of that, but it's not the main piece of our strategy.

    這就是我們的立場。我認為這是臨床證據的一部分,但我不認為這是唯一的部分。我認為我們正在與合作者合作。我們正在進行一些前瞻性研究和大量回顧性研究,你開始看到,今年 ASCO 有一批全新的研究,AACR 也有勝利研究,因此我們將繼續與越來越多的合作者和研究者合作,生物製藥最終是其中的一部分,但這不是我們戰略的主要部分。

  • Yoko N - Analyst

    Yoko N - Analyst

  • Got it. That was helpful color, and if I could squeeze one more in, one of the interesting points that Swanton made, in his AACR presentation is that, you can even stratify patients further, according to their prognosis into three buckets using an ultra-sensitive assay, how valuable has that been for biopharma?

    知道了。這很有幫助,如果我可以再補充一點的話,Swanton 在他的 AACR 演講中提出的一個有趣的觀點是,你甚至可以根據患者的預後使用超靈敏檢測將患者進一步分層為三類,這對生物製藥有多大價值?

  • Richard Chen - Executive Vice President - Research and Development, Chief Medical Officer

    Richard Chen - Executive Vice President - Research and Development, Chief Medical Officer

  • Yeah, I think, we are really interested in that data because the patient stratification obviously is a core piece of what they need to, they want to use the assay for, so I'd say, the ability to understand which patients are most at risk, and intermediate and less is an important part of that understanding for them. So yeah, it's definitely of great interest.

    是的,我認為我們對這些數據非常感興趣,因為患者分層顯然是他們需要的核心部分,他們想要使用檢測方法,所以我想說,了解哪些患者風險最高,哪些患者風險中等和較低是他們理解的重要部分。是的,這確實非常有趣。

  • Yoko N - Analyst

    Yoko N - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Swayampakula Ramakanth, H.C. Wainwright

    拉瑪坎特 (Swayampakula Ramakanth),H.C.溫賴特

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Thank you. Good afternoon, Chris and team. I really appreciate taking my questions. If any of my questions in part have been answered, I apologize for asking again because I've been in and out of calls.

    謝謝。下午好,克里斯和團隊。我非常感謝你回答我的問題。如果我的問題已經得到部分解答,我很抱歉再次詢問,因為我一直在打電話。

  • With, at a high level with all sorts of changes going on, in, various, regulatory agencies in the federal government, how confident are you, in the process, where you are, with them in terms of, getting the reimbursement approval, according to our internal timelines because. just trying to understand your confidence level there.

    隨著聯邦政府各監管機構高層發生各種變化,根據我們的內部時間表,您對獲得報銷批准的過程有多大信心。只是想了解您的信心程度。

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • No, absolutely, so we actually don't submit to CMS officially we submit to Palmetto, which is the Medicare contractor that is making the decisions for our Medicare area if you will, and Palmetto is a private company.

    不,絕對不是,所以我們實際上並沒有正式向 CMS 提交,而是向 Palmetto 提交,Palmetto 是一家醫療保險承包商,負責為我們的醫療保險領域做出決策,而 Palmetto 是一家私營公司。

  • It's been It's got the contract to do this for CMS, and we haven't seen an impact and I haven't heard of anyone in the industry having talked about an impact because of any of the changes in Washington on the process there, and you know they've been engaged, I think certainly with us but with the industry as a whole, as a part of the journey and so we don't expect anything to be changing or put any of our timelines at risk as a as a result of any of the changes in Washington relative to reimbursement.

    我們與 CMS 簽訂了合約來做這件事,我們還沒有看到任何影響,我也沒有聽說業內任何人談論過華盛頓的任何變化對那裡的流程造成的影響,你知道他們一直在參與,我認為他們肯定與我們一起,但作為整個行業的一部分,作為旅程的一部分,所以我們預計華盛頓在報銷方面發生的任何變化都不會導致任何事情發生變化或危及我們的時間表發生變化。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Yes, thanks for that. And then, I have one more quick question. Regarding the [CRC indication], what else needs to get done, so that you can get to a point where you can develop this asset further and also, look into it as a, as an asset for reimbursement.

    是的,謝謝。然後,我還有一個簡短的問題。關於[CRC 指示],還需要做什麼,以便您可以進一步開發此資產,並將其視為可報銷的資產。

  • Christopher Hall - President, Chief Executive Officer, Director

    Christopher Hall - President, Chief Executive Officer, Director

  • Yeah, no, absolutely. So the assay is ready, it's done. The assay is a, panc cancer all solid tumor assay, and it does not depend on the type of cancer.

    是的,絕對不是。因此,檢測已準備好,完成了。該檢測是一種胰腺癌全實體瘤檢測,它不依賴癌症的類型。

  • So, we create a personalized snapshot of a patient's tumor and the assay doesn't care what kind of tumor it is. So then the question has been building evidence to show that we can add incremental value in individual cancers.

    因此,我們創建了患者腫瘤的個人化快照,並且檢測並不關心它是什麼類型的腫瘤。那麼問題就是建立證據來表明我們可以在個別癌症中增加增量價值。

  • So you know that if you got the test now and I talked in the script about a patient who actually a doctor sent us his sample, and he was a colorectal cancer patient test works really well and we validated it that way. So, we feel like, we feel like the test is in good shape and is already being used for clinical use for CRC and, but we're just not obviously advocating or pushing it because you don't get paid.

    所以你知道,如果你現在接受了測試,我在腳本中談到了一位病人,實際上是一位醫生向我們發送了他的樣本,而他是一名結直腸癌患者,測試效果非常好,我們通過這種方式驗證了它。因此,我們覺得,我們覺得該測試狀況良好,並且已經用於 CRC 的臨床用途,但我們顯然不會提倡或推動它,因為你不會得到報酬。

  • The next steps, the data is in term, it still needs to be matured. That we presented and that then needs to be finalized, needs to be written into publication. It needs to be submitted and then it needs to be after it's been accepted, submitted for publication has to be accepted, and after it's been accepted, then we can submit for Medicare reimbursement.

    接下來的步驟,數據還在階段性,還需要進一步成熟。我們提出的方案需要最終確定,需要寫入出版品。它需要提交,然後它需要被接受,提交出版必須被接受,在它被接受之後,我們才能提交醫療保險報銷。

  • So we have a way to go. I don't want to sort of mis portray that's right around the corner because that always takes some time. To put that together, but you know I mean we're in this for the long term and you know having continuing to mature and build the data and having a long tail of pipeline and increasing ability to attack markets I think is important and should give investors confidence that behind breast long and IO there's more stuff on its way and that's why one of the reasons why we're super excited about it.

    所以我們還有很長的路要走。我不想錯誤地描繪即將發生的事情,因為這總是需要一些時間。總而言之,但您知道我的意思是,我們要長期堅持下去,並且要不斷成熟和構建數據,擁有長尾渠道和不斷增強的市場攻擊能力,我認為這很重要,應該讓投資者相信,在乳房長期和 IO 背後還有更多的東西在路上,這就是我們對此感到非常興奮的原因之一。

  • Swayampakula Ramakanth - Analyst

    Swayampakula Ramakanth - Analyst

  • Yeah. Great, thank you for taking my questions.

    是的。太好了,謝謝你回答我的問題。

  • Operator

    Operator

  • Thank you. This concludes today's teleconference. You may disconnect your lives at this time.

    謝謝。今天的電話會議到此結束。此時,你們可以斷開你們的生活。

  • Thank you for your participation.

    感謝您的參與。