Biodesix Inc (BDSX) 2023 Q4 法說會逐字稿

Good day and thank you for standing by, and welcome to the Biodesix fourth quarter 2023 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to Chris Brinzey, Investor Relations. Please go ahead.

美好的一天，感謝您的支持，歡迎參加 Biodesix 2023 年第四季財報電話會議。（操作員指示）請注意，今天的會議正在錄製中。我現在想將會議交給投資者關係部門的 Chris Brinzey。請繼續。

Thank you, operator, and good morning, everyone. Thank you for joining us today for a discussion of Biodesix's Inc's fourth quarter and year ended 2023 business highlights and financial results. Leading the call today will be Scott Hutton, Chief Executive Officer. You will be joined by Robin Harper Cowie, Chief Financial Officer. After the prepared remarks, we will open the call for Q&A.

謝謝接線員，大家早安。感謝您今天加入我們討論 Biodesix 公司第四季度和截至 2023 年的業務亮點和財務業績。今天的電話會議將由執行長 Scott Hutton 主持。財務長 Robin Harper Cowie 將與您一起出席。準備好發言後，我們將開始問答環節。

An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this today, we issued a press release announcing our business highlights and financial results for the fourth quarter and year ended 2023, a copy of the release can be found on the Investor Relations page of the company's website. Actual events or results may differ materially from those projected as a result of changing market trends, reduced demand and the competitive nature of the diagnostics industry. Such forward-looking statements and their implications involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those projected. Forward-looking statements discussed on this call are subject to other risks and uncertainties, including those discussed in the Risk Factors section and elsewhere in the Company's annual report on Form 10 K for the year ended December 31st, 2023, which was filed today with the Securities and Exchange Commission. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the Company's press release issued today and in the Company's filings with the SEC. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. A reconciliation to the most directly comparable GAAP financial measure is available in the press release we issued today. I would now like to turn the call over to Scott Hutton, Chief Executive Officer. Scott?

今天的電話會議的錄音和網路廣播重播也將在網上提供，詳情請參閱今天的新聞稿公告，我們發布了一份新聞稿，宣布了第四季度和截至 2023 年的業務亮點和財務業績，副本新聞稿可在公司網站的投資者關係頁面上找到。由於市場趨勢的變化、需求的減少以及診斷行業的競爭性質，實際事件或結果可能與預測有重大差異。此類前瞻性陳述及其影響涉及已知和未知的風險、不確定性和其他因素，可能導致實際結果或績效與預測有重大差異。本次電話會議中討論的前瞻性陳述受到其他風險和不確定性的影響，包括風險因素部分和公司截至2023 年12 月31 日止年度的10 K 表格年度報告中討論的風險和不確定性，該報告今天提交給了證券交易委員會。有關可能導致結果與我們的前瞻性陳述產生重大差異的因素的更多信息，在公司今天發布的新聞稿以及公司向 SEC 提交的文件中進行了更詳細的描述。這次電話會議也將討論非公認會計準則財務指標，這些指標經過調整以排除某些特定項目。我們今天發布的新聞稿中提供了與最直接可比較的公認會計準則財務指標的調節表。我現在想將電話轉給執行長 Scott Hutton。史考特？

Thank you, Chris. Happy to share that 2023 was a great year of execution at Biotix, we've been focused on three goals, driving increased revenue through the adoption of our lung diagnostic test and our biopharma and diagnostic services implementing operational efficiencies to improve gross margins and maintaining a strict cost discipline. In 2023, we delivered approximately 38,700 lung diagnostic tests, which represents 65% growth over 2022, we increased our gross margins over the course of the year to 77%. And we improved our fourth quarter adjusted EBITDA by 55% over the comparable period. Our team and culture have never been stronger, and you see that strength reflected in our results. I want to express my sincere gratitude to our team for their hard work and dedication to improving the lives of patients and the health care professionals that serve it.

謝謝你，克里斯。很高興與大家分享，2023 年是Biotix 執行的偉大一年，我們一直專注於三個目標，透過採用我們的肺部診斷測試以及我們的生物製藥和診斷服務來增加收入，提高運營效率以提高毛利率並維持嚴格的成本紀律。2023 年，我們提供了約 38,700 次肺部診斷測試，比 2022 年增加了 65%，全年毛利率提高至 77%。我們在第四季度調整後 EBITDA 比同期提高了 55%。我們的團隊和文化從未如此強大，您會看到這種力量反映在我們的成果中。我想對我們的團隊表示衷心的感謝，感謝他們的辛勤工作和奉獻精神，以改善患者和為其服務的醫療保健專業人員的生活。

Our top priority remains the ongoing adoption of our five blood-based tests for patients with potentially cancerous lung nodules and those with lung cancer. This past quarter, we delivered approximately 10,900 test results, reflecting growth of 54% as compared to the approximately 7,100 test results delivered in the fourth quarter of 2022. This is the sixth straight quarter of at least 50% year-over-year growth, primarily driven by our notify CDT. and XL. two lung testing volumes. Lung nodule management is by far the largest market we serve and will continue to be the largest driver of lung diagnostic test volume growth. Our industry-leading commercial team was responsible for driving this outstanding growth in 2023. We continued to invest and expand our organization throughout the year, finishing with approximately 50 fully trained representatives with an additional 10 that came on board late in Q4. On average, our sales representatives begin paying for themselves within two to three months. Therefore, we expect these new teammates to begin contributing in the first quarter of 2024. We also validated the benefit of adding ASSOCIATE sales consultants into existing territories, working alongside established team members to improve account retention and penetration while building a bench for future expansion. As a result, 2024 will see an ongoing expansion that includes splitting existing territories into more manageable geographies as the business grows, with an increase in the number of territories holding both a sales consultant and an associate sales consultant that will accelerate adoption within those territories in the second half of 2023, the publication of the primary endpoint for the Oracle prospective registry study was published.

我們的首要任務仍然是對潛在癌性肺結節和肺癌患者持續採用五種基於血液的檢測。上一季度，我們交付了約 10,900 份測試結果，與 2022 年第四季度交付的約 7,100 份測試結果相比增長了 54%。這是連續第六個季度同比增長至少 50%，這主要是由我們的通知 CDT 推動的。和XL。兩次肺部測試量。肺結節管理是迄今為止我們服務的最大市場，並將繼續成為肺部診斷測試量成長的最大驅動力。我們業界領先的商業團隊推動了 2023 年的這項出色成長。我們全年繼續投資和擴大我們的組織，最終擁有約 50 名訓練有素的代表，另外 10 名代表於第四季末加入。平均而言，我們的銷售代表會在兩到三個月內開始收回成本。因此，我們預計這些新隊友將在 2024 年第一季開始做出貢獻。我們還驗證了在現有地區添加助理銷售顧問的好處，與現有團隊成員一起工作，以提高客戶保留率和滲透率，同時為未來的擴張奠定基礎。因此，到2024 年，業務將持續擴張，其中包括隨著業務的成長，將現有區域劃分為更易於管理的區域，同時擁有銷售顧問和助理銷售顧問的區域數量將會增加，這將加速這些區域在2023 年下半年，Oracle 前瞻性註冊研究的主要終點公佈。

The data showed that use of the notify XL two tests resulted in a 74% reduction in costly and unnecessary biopsies and or surgeries on patients with benign lung nodules. In addition to this data, an independent group of academic medical centers published a 73% reduction in unnecessary procedures, clearly demonstrating the clinical utility of notify in the real-world clinical setting. Peer-reviewed publications such as these are critical to help expand physician adoption of our test as well as expanding payer coverage. In addition to the growth in volumes driven by our sales team, broadening reimbursement coverage remains an important part of our growth strategy. In July, the notified CDT test was awarded advanced diagnostic laboratory test or ADLT status by the Center for Medicare and Medicaid Services. Receiving ADLT status is a major milestone for the BioDisc 16, as this is reserved for innovative test with Medicare coverage that provide clinical value and new diagnostic information that cannot be obtained from any other test or combination of tests.

數據顯示，使用notify XL 兩項檢測可使良性肺結節患者的昂貴且不必要的活檢和/或手術減少74%。除了這些數據之外，一個獨立的學術醫療中心小組還公佈了不必要的程序減少了 73%，清楚地證明了通知在現實臨床環境中的臨床效用。諸如此類的同行評審出版物對於幫助擴大醫生對我們的測試的採用以及擴大付款人的覆蓋範圍至關重要。除了我們的銷售團隊推動的銷售成長之外，擴大報銷範圍仍然是我們成長策略的重要組成部分。7 月，通知的 CDT 測試被醫療保險和醫療補助服務中心授予高級診斷實驗室測試或 ADLT 狀態。獲得 ADLT 狀態是 BioDisc 16 的一個重要里程碑，因為這是為 Medicare 承保範圍內的創新測試而保留的，這些測試可提供無法從任何其他測試或測試組合中獲得的臨床價值和新診斷資訊。

The ADLT status is a public recognition of unique clinical utility. Notify CDT. joins notify XL two and various threat. And having received that important classification in late fourth quarter, Geisinger Health Plan issued a positive coverage decision for notify lung testing, including both the notify CDT. and notify XL to blood-based proteomic tests guiding our health plan was the first commercial plan to cover notify CDT. The combined coverage of both notify CDT. and notify access to testing recognizes the importance of these tests in assisting healthcare professionals in lung nodule management to help improve patient outcomes.

ADLT 地位是對獨特臨床實用性的公眾認可。通知 CDT。加入通知XL 兩個和各種威脅。在第四季度末收到這一重要分類後，Geisinger Health Plan 發布了通知肺部檢測（包括通知 CDT）的積極承保決定。並通知 XL 進行基於血液的蛋白質組學測試，指導我們的健康計劃是第一個涵蓋通知 CDT 的商業計劃。兩者的綜合覆蓋範圍通知 CDT。並通知獲得測試的機會認識到這些測試在協助醫療保健專業人員進行肺結節管理以幫助改善患者治療結果方面的重要性。

Moving on to our Biopharmaceutical Services business. We generated exceptional momentum in the second half of the year with more than 35% year-over-year growth in each of the last two quarters. We are encouraged with the strong growth this quarter and are pleased to see an increasing number of samples received from several different biopharma companies, running multiple clinical studies and an increasing number of incoming RFPs and opportunities. In addition, our team continues to deliver on test process automation and workflow optimization projects that have driven a steady increase in gross margins over the course of 2023, ending the fourth quarter with 77% gross margin, an increase of 11 points over Q4 of 2022. We've been exceptionally effective in providing our tests with industry-leading turnaround times, and we've made great strides in becoming even more efficient in the delivery of those tests.

繼續我們的生物製藥服務業務。我們在下半年創造了非凡的發展勢頭，過去兩個季度的同比增長均超過 35%。我們對本季度的強勁成長感到鼓舞，並很高興看到從多家不同的生物製藥公司收到的樣本數量不斷增加，開展多項臨床研究以及收到的 RFP 和機會數量不斷增加。此外，我們的團隊繼續交付測試流程自動化和工作流程優化項目，這些項目推動了 2023 年毛利率的穩步增長，第四季度末毛利率為 77%，比 2022 年第四季度增長了 11 個百分點。我們在提供業界領先的周轉時間方面非常有效，並且在更有效率地交付這些測試方面取得了巨大進步。

Finally, our commitment to a cost disciplined approach while growing and expanding the business continues to deliver tangible results. Adjusted EBITDA in the fourth quarter improved 55% over the same period in 2022. We've built a commercial and operational platform that will help facilitate long-term consistent, sustainable growth. And I believe everyone is beginning to appreciate the leverage that exists within the business model and our efforts to demonstrate the team's significant progress and outstanding execution on our path to profitability.

最後，我們在發展和擴大業務的同時對成本控制方法的承諾繼續帶來切實的成果。第四季調整後 EBITDA 較 2022 年同期成長 55%。我們建立了一個商業和營運平台，將有助於促進長期一致、可持續的成長。我相信每個人都開始欣賞商業模式中存在的槓桿作用，以及我們為展示團隊在獲利之路上取得的重大進展和出色執行力所做的努力。

Before I turn the call over to Robin, I'd like to reiterate our commitment to transform the standard of care in lung cancer and improve patient outcomes with personalized diagnostics. Lung cancer is still the deadliest of all cancers as it claims more lives annually in the United States than the combined total of the next three deadliest cancers, breast, prostate and colon cancer time is of the essence when it comes to diagnosing and treating these patients by discovering, developing and commercializing tests with demonstrated clinical utility and best-in-class turnaround times. We believe that our diagnostic tests play a critical role in these efforts to treat the right patients quickly and effectively.

在將電話轉給 Robin 之前，我想重申我們致力於改變肺癌護理標準並透過個人化診斷改善患者治療效果的承諾。肺癌仍然是所有癌症中最致命的，因為在美國，肺癌每年奪去的生命比緊隨其後的三種最致命癌症（乳腺癌、前列腺癌和結腸癌）的總和還要多，在診斷和治療這些患者時，時間至關重要透過發現、開發和商業化具有經過驗證的臨床實用性和一流週轉時間的測試。我們相信，我們的診斷測試在快速有效地治療合適患者的努力中發揮著至關重要的作用。

With that, let me turn it over to Robin to review the fourth quarter and year-end 2023 financial performance Thanks, Scott.

接下來，讓我將其交給 Robin 來回顧第四季度和 2023 年底的財務業績，謝謝，斯科特。

Fourth quarter total revenue was $14.7 million, a 53% increase over the prior year. Full year revenue in 2023 was $49.1 million, a 49% increase over prior year, excluding 2022, COVID revenue of $5.2 million and a 28% increase over full year revenue in 2022, including COVID revenue. As Scott mentioned, we delivered approximately 10,900 lung diagnostic test results in the fourth quarter, up versus approximately 7,100 test results for Q4 2022 and approximately 38,700 lung diagnostic tests results for full year 2023 versus 23,500 tests results for the full year 2022, a 54% increase and 65% increase respectively. Test volume in the quarter was our sixth straight quarter of at least 50% year-over-year growth.

第四季總營收為 1,470 萬美元，比上年同期成長 53%。2023 年全年營收為 4,910 萬美元，較上年增長 49%，不包括 2022 年，新冠肺炎收入為 520 萬美元，較 2022 年全年收入（包括新冠肺炎收入）增長 28%。正如Scott 所提到的，我們在第四季度提供了大約10,900 項肺部診斷測試結果，而2022 年第四季度提供了大約7,100 項測試結果，2023 年全年提供了大約38,700 項肺部診斷測試結果，而2022 年全年提供了23,500 項測試結果，成長了54%分別成長 65% 和 65%。本季的測試量連續第六個季度年增至少 50%。

Lung diagnostic revenue in the fourth quarter was $12.8 million compared to $8.2 million for the fourth quarter of 2022 an increase of 55% over prior year one. Diagnostic revenue for the full year 2023 was $45.1 million, a 54% increase over full year 2022. As we've discussed in prior earnings calls, we continue to experience delays in some Medicare Advantage payments for our Medicare covered tests from certain payers. While we continue to work with the plans to resolve the administrative hurdles. The backlog continues to grow and ended the year at approximately three to $3.5 million, up from 2.5 to $3 million reported in our third quarter earnings call. We will continue to provide updates in our calls as we work towards a satisfactory resolution biopharmaceutical services revenue was $1.9 million in the quarter compared to $1.35 million in the fourth quarter of 2022 and $3.9 million for the full year 2023 compared to $3.7 million for the full year 2022, an increase of 38% and 6% over the respective prior year comparable periods. As a reminder, this business can fluctuate due to several factors, including contract timing and project execution. And while we had a strong quarter, we did experience a delay in the receipt of samples for a large project, resulting in approximately $600,000 in revenue pushing from the fourth quarter into the first half of 2024. Overall, we ended the year with $7.9 million contracted, but not yet recognized as revenue. The decrease in contracted revenue from the third quarter is something we typically see as we complete contracts and record higher revenue totals like we did in the second half of the year. However, it's important to note that the number of incoming requests have continued to be strong in the first eight weeks of 2024, and we have a robust pipeline since the beginning of the year. We have signed new contracts and increased our total dollars under contract, but not yet recognized to $9.1 million as of today, gross margin percentage in the fourth quarter 2023 increased to 77% versus 66% in the prior year quarter and 76% in the third quarter of 2023. Current gross margin trends reflect the growth in our lung diagnostic testing in successful completion of projects to decrease costs and optimize testing workflows. The steady improvement across 2023 resulted in full year gross margins of 73% versus 63% for the full year 2022, we anticipate the ability to maintain margins in the mid 70s going forward.

第四季肺部診斷收入為 1,280 萬美元，而 2022 年第四季為 820 萬美元，比上年第一季成長 55%。2023年全年診斷收入為4,510萬美元，較2022年全年成長54%。正如我們在先前的財報電話會議中所討論的那樣，我們繼續遇到某些付款人對 Medicare 承保測試的某些 Medicare Advantage 付款的延遲。同時，我們將繼續按照計畫解決行政障礙。積壓訂單持續成長，到年底約為 300 至 350 萬美元，高於我們第三季財報電話會議報告的 250 至 300 萬美元。我們將繼續在電話中提供最新信息，努力達成令人滿意的解決方案。本季生物製藥服務收入為190 萬美元，而2022 年第四季為135 萬美元，2023 年全年為390 萬美元，而全年生物製藥服務收入為370 萬美元。2022年，較上年同期分別成長38%及6%。提醒一下，這項業務可能會因多種因素而波動，包括合約時間和專案執行。雖然我們的季度業績表現強勁，但我們確實遇到了大型專案樣品接收延遲的情況，導致約 60 萬美元的收入從第四季度推至 2024 年上半年。總體而言，我們年底簽訂了 790 萬美元的合同，但尚未確認為收入。第三季合約收入的下降是我們通常會看到的情況，因為我們像下半年一樣完成了合約並創下了更高的收入總額。然而，值得注意的是，傳入請求的數量在 2024 年的前八週持續強勁，而且自年初以來我們擁有強勁的管道。我們已經簽署了新合同，並增加了合約總金額，但截至今天尚未確認為 910 萬美元，2023 年第四季度的毛利率增至 77%，而去年同期為 66%，第三季度為 76% 2023 年第四季。目前的毛利率趨勢反映了我們的肺部診斷測試在成功完成專案以降低成本和優化測試工作流程方面的成長。2023 年的穩定改善導致全年毛利率達到 73%，而 2022 年全年毛利率為 63%，我們預計未來有能力將利潤率維持在 70 年代中期。

Overall, operating expense, excluding direct costs and expenses, was $18.2 million in the fourth quarter 2023 compared to $20.2 million for the same period of 2022 and $17.4 million in the third quarter of 2023. The decrease in operating expense versus the prior year quarter is primarily the result of a decrease in R&D expense and G&A, partially offset by increased sales and marketing costs. To support long diagnostic sales growth to enhance product awareness and drive adoption.

整體而言，2023 年第四季的營運費用（不包括直接成本和費用）為 1,820 萬美元，而 2022 年同期為 2,020 萬美元，2023 年第三季為 1,740 萬美元。與去年同期相比，營運費用的下降主要是由於研發費用和一般行政費用的減少，但部分被銷售和行銷成本的增加所抵銷。支持診斷銷售的長期成長，以提高產品認知度並推動採用。

Total operating expenses, excluding direct costs and expenses for the full year 2023 were $77.4 million versus $74.6 million in 2022. For the full year 2023, the slight increase as compared to the prior year period is related to increased sales and marketing expense, partially offset by the realization of savings from our prioritization of projects that are expected to result in near-term revenue and the delay of longer-term projects.

2023 年全年的總營運費用（不包括直接成本和費用）為 7,740 萬美元，而 2022 年為 7,460 萬美元。2023 年全年，與去年同期相比略有增加是由於銷售和行銷費用增加，但部分被我們優先考慮預計會帶來短期收入的項目所實現的節省和延遲所抵消的長期項目。

Operating expense for the fourth quarter 2023 includes $1.1 million in non-cash stock compensation expense as compared to $2.1 million during the fourth quarter of 2022. For the full year 2023, non-cash stock comp expense was $5.4 million compared to $6.0 million for the full year 2022.

2023 年第四季的營運費用包括 110 萬美元的非現金股票補償費用，而 2022 年第四季的營運費用為 210 萬美元。2023 年全年非現金股票補償費用為 540 萬美元，而 2022 年全年非現金股票補償費用為 600 萬美元。

Net loss for the fourth quarter 2023 was $9.1 million compared to a $20.3 million net loss for the same period of 2022 and $10.9 million for third quarter 2023. Net loss for the full year ended 2023 was $52.1 million compared to a $65.4 million net loss for the full year 2022. The decrease in net loss for both the quarter and the full year was driven primarily by the increase in revenue, improvements in gross margin and reduction in certain operating expenses, including R&D expense, as well as a reduction in noncash stock-based compensation.

2023 年第四季的淨虧損為 910 萬美元，而 2022 年同期的淨虧損為 2,030 萬美元，2023 年第三季的淨虧損為 1,090 萬美元。截至 2023 年全年的淨虧損為 5,210 萬美元，而 2022 年全年淨虧損為 6,540 萬美元。本季和全年淨虧損的減少主要是由於收入增加、毛利率改善和某些營運費用（包括研發費用）的減少以及非現金股票薪酬的減少所致。

Fourth quarter and Fiscal Year 2023 included a gain of $0.1 million and loss of $1.3 million, respectively, from the change in fair value of warrant liabilities associated with our term loan facility with Perceptive Advisors.

2023 年第四季和 2023 財年，我們與 Perceptive Advisors 的定期貸款融資相關的認股權證負債公允價值變化分別帶來了 10 萬美元的收益和 130 萬美元的損失。

Our fourth quarter and fiscal year 2022 included a onetime loss of approximately $4.0 million and $7.0 million, respectively for the extinguishment of debt to provide better clarity of progress on our path to profitability. During the third quarter, we started reporting adjusted EBITDA, which excludes certain noncash items and COVID-19 testing revenue and direct costs and expenses.

我們的第四季和 2022 財年分別出現了約 400 萬美元和 700 萬美元的一次性虧損，因為債務清償的目的是為了讓我們在獲利之路上取得的進展更加清晰。第三季度，我們開始報告調整後的 EBITDA，其中不包括某些非現金項目和 COVID-19 測試收入以及直接成本和費用。

Adjusted EBITDA for the fourth quarter 2023 was a loss of $4.9 million compared to a loss of $10.8 million for the fourth quarter 2020 to a 55% improvement, an 11% improvement over the third quarter of 2023. Adjusted EBITDA for the full year 2023 was a loss of $32.7 million compared to a loss of $43.2 million for full year 2022 and a 24% improvement. The improvement in adjusted EBITDA in both the fourth quarter and for the full year demonstrates our focus on actively managing our operating expenses. Our success in improving gross margins and driving growth in top-line revenue, resulting in a decrease to our cash burn. We ended the year with 26.3 million in unrestricted cash and cash equivalents as compared to $19.8 million at the end of the third quarter, an increase of $6.5 million, which included the addition of the remaining $12.2 million from the $27.5 million private placement announced in August and $10 million that was drawn from the second tranche of our $50 million term loan facility with Perceptive Advisors. This was offset by our integrated diagnostics milestone payment of $3.5 million, an additional $3 million for onetime CapEx used to complete work on our new facility, which is now fully operational and cash used to fund operations and working capital. I do want to remind you of our required shift in the display of the milestone payments to integrated diagnostics on our statement of cash flows.

2023 年第四季度調整後 EBITDA 虧損 490 萬美元，與 2020 年第四季虧損 1,080 萬美元相比，改善了 55%，比 2023 年第三季改善了 11%。2023 年全年調整後 EBITDA 虧損 3,270 萬美元，而 2022 年全年虧損 4,320 萬美元，改善 24%。第四季和全年調整後 EBITDA 的改善顯示我們致力於積極管理營運費用。我們成功提高毛利率並推動營收成長，從而減少了現金消耗。截至年底，我們的非限制性現金和現金等價物為 2,630 萬美元，而第三季末為 1,980 萬美元，增加了 650 萬美元，其中包括 8 月份宣布的 2,750 萬美元私募中剩餘的 1,220 萬美元。 1000 萬美元是從我們與Perceptive Advisors 合作的5000 萬美元定期貸款融資的第二部分中提取的。這被我們的綜合診斷里程碑付款 350 萬美元所抵消，另外 300 萬美元用於完成我們新設施的一次性資本支出，該設施現已全面投入運營，現金用於為運營和營運資金提供資金。我確實想提醒您，我們需要將里程碑付款的顯示轉變為現金流量表上的綜合診斷。

As I mentioned last quarter, payments made through the third quarter of 23 have been classified as cash outflows from financing activities in our statement of cash flows. However, beginning with a portion of the milestone payment made in the fourth quarter, as well as all milestone payments to be made in 2024, these payments are now classified as cash outflows from operating activities due to the applicable US GAAP requirements. For clarity, the dollar amounts are not changing just where they're required to be captured on the statement of cash flows.

正如我上季度提到的，截至 23 年第三季的付款已在我們的現金流量表中歸類為融資活動現金流出。然而，從第四季度支付的部分里程碑付款以及 2024 年支付的所有里程碑付款開始，由於適用的美國公認會計原則要求，這些付款現在被歸類為經營活動現金流出。為清楚起見，美元金額並不僅僅在現金流量表中需要記錄的地方發生變化。

Finally, turning to 2024 guidance. We plan to deliver $65 million to $68 million in total revenue, driven primarily by growth in lung diagnostics with modest increases from our biopharma services offerings. This guidance does not include any expected revenues from the Medicare Advantage backlog.

最後，轉向 2024 年指引。我們計劃實現 6500 萬至 6800 萬美元的總收入，這主要是由肺部診斷的增長以及我們的生物製藥服務產品的小幅增長推動的。本指南不包括 Medicare Advantage 積壓的任何預期收入。

Now let me turn it back to Scott. Scott?

現在讓我把它轉回給史考特。史考特？

Thanks, Robin. We've again achieved impressive and high double digit growth in the past quarter, attributed to the exceptional performance of our consultative lung focused commercial team who have been instrumental in fueling our success. We've improved our already strong gross margins and made substantial progress on our path to profitability. 2024 is a year of execution on our three goals driving increased revenue by accelerating the adoption of our lung diagnostic test and biopharma services, implementing operational efficiencies to improve gross margins and maintaining a strict cost discipline. By aligning these three strategic efforts. We're confident in our ability to sustain our aggressive growth trajectory, make progress on our path to profitability and deliver value to the health care professionals, their patients and all shareholders. We are transforming the standard of care and are excited to be making such a significant impact.

謝謝，羅賓。我們在過去的季度再次實現了令人印象深刻的兩位數成長，這要歸功於我們以肺部為中心的諮詢商業團隊的出色表現，他們在推動我們的成功方面發揮了重要作用。我們已經提高了本已強勁的毛利率，並在獲利之路上取得了實質進展。 2024 年是我們執行三個目標的一年，即透過加速採用我們的肺部診斷測試和生物製藥服務、提高營運效率以提高毛利率以及維持嚴格的成本紀律來推動收入成長。透過協調這三項戰略努力。我們相信我們有能力維持積極的成長軌跡，在獲利之路上取得進展，並為醫療保健專業人員、他們的患者和所有股東創造價值。我們正在改變護理標準，並很高興能夠產生如此重大的影響。

Finally, we've completed the move into our new 80,000 square foot state-of-the-art corporate office and clinical laboratory in Lewisville, Colorado. We believe this new facility provides another competitive advantage and enables us to grow and expand in an efficient and effective manner.

最後，我們已完成遷入科羅拉多州路易斯維爾佔地 80,000 平方英尺、最先進的新公司辦公室和臨床實驗室。我們相信，這個新設施提供了另一個競爭優勢，使我們能夠以高效且有效的方式成長和擴張。

With that, I'll turn the call over to the operator for questions.

這樣，我會將電話轉給接線生詢問問題。

(Operator Instructions) Andrew Brackmann, William Blair.

（操作員說明）安德魯·布拉克曼、威廉·布萊爾。

Got Robin. Good morning. Thanks for taking the question. I have a few maybe to start here on revenue guidance for the year and nice to see that solid growth outlook that you just talked about, but you maybe help parse out some of the build there. I guess I'm just looking for things related to sort of rep adds utilization increases, new accounts, revenue per test? Any color there might be appreciated.

得到了羅賓。早安.感謝您提出問題。我可能會從今年的收入指導開始，很高興看到您剛才談到的穩健的成長前景，但您也許可以幫助解析那裡的一些構建。我想我只是在尋找與代表增加利用率增加、新帳戶、每次測試收入相關的事情？任何顏色都可能會受到讚賞。

Yes, good morning, Andrew. Thanks for the question on. Yes, you know, we talked a lot about sales force expansion and growth. And as you just heard, we exited the year right at about 50 sales reps contributing. We're going to continue to grow and expand that sales force. What we do know from the past performance and obviously a modeling perspective, we've seen our sales professionals come on and start to pay for themselves in about three months. The one thing we're mindful of is as we continue to expand into territories where we haven't had representation prior on that ramp may be a little bit slower on. And then as we look at promoting associate sales consultants into open territories, which we Dan. We had five that we promoted towards the end of the year, which really demonstrates that our plan and approach is working we still know that those are going to be junior young sales professionals. So we really looked at this trying to improve forecast accuracy, ensure that we put them in a position to succeed.

是的，早上好，安德魯。感謝您提出的問題。是的，您知道，我們談論了很多關於銷售隊伍擴張和成長的問題。正如您剛剛聽說的那樣，今年結束時我們有大約 50 名銷售代表做出了貢獻。我們將繼續發展並擴大銷售團隊。從過去的表現以及顯然從建模的角度來看，我們確實知道，我們已經看到我們的銷售專業人員開始在大約三個月內收回成本。我們要注意的一件事是，隨著我們繼續擴展到之前沒有代表的領域，速度可能會慢一些。然後，當我們考慮將助理銷售顧問提升到開放領域時，我們丹了。我們在年底晉升了五個人，這確實表明我們的計劃和方法正在發揮作用，我們仍然知道這些人將是初級年輕銷售專業人員。因此，我們確實考慮了這一點，試圖提高預測準確性，確保我們讓他們能夠取得成功。

What we've seen from a sales rep productivity number really is we can get them into that 750,000 to 1 million per rep in a pretty reasonable timeframe. One of the things we've disclosed in the past is we have seen some sales professionals get north of 1.5 million per rep, but we cut their territories so we were never really striving to see. Could we get them to $2 million. We wanted to make certain that we could cut territories and then demonstrate that they could grow. Again, we just wrapped up our national sales meeting, Andrew and I share this with you. We have a back-to-back top sales rep of the year. What makes that most remarkable his two years ago, she won with an associate sales consultant. At the end of the year, we split her territory, promoted the associate sales consultant into one half of that territory. They both finished in the top five. So what we've really proven out is we can go deep. I use the word consultative. I think the more we put our sales professionals in health care, professional offices. They're going to find that we are consultative. We bring tremendous value and the value of our the clinical value of our test isn't really questioned. So again, we haven't seen where we can cap out on that sales rep productivity number just yet. So we factored all of the past performance into modeling really what we think in that guide range is achievable for us this year.

我們從銷售代表的生產力數字中看到，我們確實可以在相當合理的時間內將每個銷售代表的生產力提高到 75 萬到 100 萬。我們過去披露的一件事是，我們看到一些銷售專業人士的每位代表收入超過 150 萬，但我們削減了他們的領地，因此我們從未真正努力看到這一點。我們能讓他們拿到200萬美元嗎？我們希望確保我們可以削減領土，然後證明它們可以成長。同樣，我們剛剛結束了全國銷售會議，安德魯和我與您分享這一點。我們連續獲得年度最佳銷售代表。兩年前，最引人注目的是她與副銷售顧問一起獲勝。年底，我們分割了她的領地，將助理銷售顧問提升到了一半的領地。他們都進入了前五名。所以我們真正證明的是我們可以深入研究。我使用“協商”這個詞。我認為我們將更多的銷售專業人員放在醫療保健、專業辦公室。他們會發現我們是在協商。我們帶來了巨大的價值，我們的測試的臨床價值確實沒有受到質疑。再說一次，我們還沒有看到我們可以在哪裡限制銷售代表的生產力數字。因此，我們將過去的所有表現都納入了模型中，我們認為今年在該指導範圍內可以實現的目標。

That helpful. Very helpful. Thanks for all that color. I guess related to sort of the outlook here you're making really nice progress on the margin front and sort of reducing operational burn. Can you maybe just sort of talk about how we should think about further reductions in that burn metric this year and the sort of leverage that you expect in the model throughout 2024?

很有幫助。很有幫助。感謝所有這些顏色。我想這與這裡的前景有關，您在利潤率方面取得了非常好的進展，並在某種程度上減少了營運消耗。您能否談談我們應該如何考慮今年燃燒指標的進一步減少以及您期望在整個 2024 年模型中發揮什麼樣的槓桿作用？

Yes. Andrew, you've actually been out here and you've seen the facility, the new facility really should empower us to continue to make some improvements with focused over the last three to four years on workflow and operational efficiencies. And obviously, we've made those and achieved those one of the things most may not appreciate is that the old facility was really constructed for one product in the laboratory. And so we ran out of space. We were limited in what we were able to do moving into the new facility gives us the ability to it took to move forward with growth and expansion in mind. So we think that we're set up to continue to improve that. We're also mindful that we believe we've got industry-leading gross margins. We're aware of one, maybe two other diagnostic companies that are in the ballpark maybe slightly better. So we also want to be realistic. We're still forecasting for modest improvements there to take us into that mid and keep us in that mid 70s range.

是的。安德魯，您實際上已經來到這裡並且看到了該設施，新設施確實應該使我們能夠繼續進行一些改進，並在過去三到四年內重點關注工作流程和營運效率。顯然，我們已經製造了這些並實現了這些，但最令人不欣賞的事情之一是舊設施實際上是為實驗室中的產品建造的。所以我們的空間就用完了。我們的能力有限，搬入新工廠使我們有能力在成長和擴張的同時繼續前進。所以我們認為我們已經準備好繼續改進這一點。我們也注意到，我們相信我們擁有領先業界的毛利率。我們知道另外一家，也許還有兩家診斷公司的情況可能稍微好一點。所以我們也想現實一點。我們仍然預測那裡會有適度的改進，使我們進入這個中期並保持在 70 年代中期的範圍內。

Yes, from an operation expense standpoint, it remains one of our top goals and focus for 2024 and maintaining that strict cost discipline being very efficient and effective with our cash to keep driving down our overall burn and mix continued progress on our path to profitability.

是的，從營運費用的角度來看，這仍然是我們2024 年的首要目標和重點之一，並保持嚴格的成本紀律，非常有效率和有效地利用我們的現金，繼續降低我們的整體消耗，並在盈利之路上不斷取得進展。

That's great. And then maybe if I could just a bigger picture question here. You know, it's been a couple of years since USPSTF updated their screening guidelines. We should hopefully get some sort of update on the development of quality measures there for screening later this year. So I think it's sort of fair to say there's going to be a lot of tailwinds in nodule identification over the next couple of years for domestics, in particular, no aside from continuing to invest in that commercial team. I guess, can you talk about some of the things that are in your control to really ensure that you're going to be that go-to solution for nodule management as all of these tailwinds sort of play out here over the next few years?

那太棒了。也許我可以在這裡提出一個更大的問題。您知道，USPSTF 更新其篩選指南已經有幾年了。我們預計在今年稍後獲得有關品質措施制定的一些最新信息，以便進行篩選。因此，我認為可以公平地說，未來幾年對於國內結核病識別將會有很多順風車，尤其是，除了繼續投資這個商業團隊之外。我想，您能否談談您可以控制的一些事情，以真正確保您將成為結核管理的首選解決方案，因為所有這些順風車都會在未來幾年中發揮作用？

Thanks. Yes, it's a really insightful question, Andrew. Thank you. Yes, I think I think you're right, we're all eager to see what USPSTF change and screening guidelines does and what that impact is. Obviously, everybody's got their fingers crossed that it that it improved those numbers and that we see more early detection and diagnosis because we're dealing with the deadliest of all cancers that we know right now that the first thing that will improve outcomes is that early detection and diagnosis. So we'll eagerly sit back and wait for that. We also know and we've seen what the Helios measures did in breast cancer and so right now, we're anticipating he just measures for lung cancer to go into effect in the third and fourth quarter of this year. That will also continue to drive not only increased awareness, but hopefully it helps drive broader adoption of nodule management clinics, screening programs.

謝謝。是的，這是一個非常有洞察力的問題，安德魯。謝謝。是的，我認為你是對的，我們都渴望看到 USPSTF 的變化和篩檢指南的作用以及影響是什麼。顯然，每個人都祈禱它改善了這些數字，並且我們看到了更多的早期檢測和診斷，因為我們正在應對所有癌症中最致命的癌症，我們現在知道，改善結果的第一件事就是早期發現和診斷。檢測和診斷。因此，我們將熱切地坐下來等待。我們也知道並且已經看到了赫利俄斯措施對乳癌的作用，因此現在我們預計他對肺癌的措施將在今年第三和第四季生效。這不僅將繼續提高人們的認識，而且希望它有助於推動結節管理診所和篩檢計劃的更廣泛採用。

So for us, as you as you referenced, the expansion of our sales force is not just about hiring new sales professionals. It's empowering them to partner with those health care professionals and clinicians to work on nodule management programs. And so we spend a lot of time in peer-to-peer education, where some physicians will share their experiences on nodule management programs, their experiences with patients that have been identified through a screening program. So we're collaborating across this entire care continuum. And we think that's one of the ways that not only will we become a trusted partner, but that this becomes sustainable, right? It's not just about driving test volume adoption it's about building relationships and partnering to make the biggest impact we can in the deadliest of all cancers.

因此，對我們來說，正如您所提到的，我們銷售隊伍的擴張不僅僅是僱用新的銷售專業人員。它使他們能夠與醫療保健專業人員和臨床醫生合作開展結節管理計劃。因此，我們花了很多時間進行同儕教育，一些醫生將分享他們在結節管理計劃方面的經驗，以及他們與透過篩檢計畫確定的患者的經驗。因此，我們正在整個護理過程中進行合作。我們認為，這不僅是我們成為值得信賴的合作夥伴，也是永續發展的方式之一，對嗎？這不僅是推動測試量的採用，還在於建立關係和合作，以在所有最致命的癌症中發揮最大的影響力。

Thank you. I'll leave it there. Thanks, guys. Thanks, Robin.

謝謝。我會把它留在那裡。多謝你們。謝謝，羅賓。

Thanks, Andrew.

謝謝，安德魯。

Kyle Nixon, Canaccord Genuity.

凱爾·尼克松，Canaccord Genuity。

Hey, thanks. Congrats on the year. And Robin, just questions for you to start on financials on working capital I think like current assets such as accounts receivable stepped up materially in 4Q. Just wondering why that wasn't anything to read into in terms of how net working capital and cash conversion cycle could kind of progress in the near term? And then secondly, could you you probably do this, but could you quantify the and the backlog in terms of revenue like you either revenue or volume? I guess I'd be it would be helpful. Just to kind of understand how to on the apples-to-apples comparison in this guidance.

嘿，謝謝。恭喜過年。羅賓，我想問你一個關於營運資本財務狀況的問題，我認為應收帳款等流動資產在第四季大幅增加。只是想知道為什麼就淨營運資本和現金轉換週期在短期內如何取得進展而言沒有任何值得解讀的內容？其次，你可以這樣做嗎？但是你能像收入或數量一樣量化收入和積壓嗎？我想我會很有幫助。只是為了了解如何在本指南中進行同類比較。

Yes, absolutely. And good morning, Kyle, thanks for the questions. About working capital did see a step up towards the end of the year. We do typically see that in Q4 just from timing and holidays. Some we see insurance companies slow down a little bit towards the end of the year. And but also with the increase in test volumes, we do expect an increase in ARCO., there are no no delays or anything of concern to be aware?

是的，一點沒錯。早安，凱爾，謝謝你的提問。到年底，營運資金確實增加。我們通常會在第四季度看到這一點，僅從時間和假期來看。我們看到一些保險公司在年底前放緩了一些步伐。而且隨著測試量的增加，我們確實預期 ARCO 會增加。有沒有延遲或任何需要注意的問題？

Well aware of about the meta met advantage backlog. It's really just a couple of Medicare Advantage companies the rest are paying quite well and on time and it is now about three to $3.5 million worth of backlog. That's up about $0.5 million from the fourth quarter or sorry, from the end of the third quarter. So that increase in the fourth quarter. And we remove and all all of that from our guidance for 2024. So we did not have any anticipated collections on the backlog included in our guidance. We also remove any anticipated collections from current claims from those impacted health plans from the guidance as well to try and minimize any sort of variability that you see in our revenue. Now, obviously, that means if we're able to get to rapid resolution there, that we should see some upside and we are working diligently with those plans to get these administrative hurdles resolved. So once we have them have anything more to share on that, we will be very happy to share.

非常了解元遇見優勢積壓。實際上只有幾家 Medicare Advantage 公司，其餘公司都按時支付了相當不錯的費用，現在積壓的金額約為 3 至 350 萬美元。這比第四季度，或者抱歉，比第三季末增加了約 50 萬美元。因此第四季的成長。我們從 2024 年的指導中刪除了所有這些內容。因此，我們的指南中沒有包含任何預期的積壓工作收集。我們還從指南中刪除了受影響的健康計劃的當前索賠中的任何預期收款，並嘗試盡量減少您在我們的收入中看到的任何類型的變化。現在，顯然，這意味著如果我們能夠快速解決問題，我們應該會看到一些好處，並且我們正在努力製定這些計劃，以解決這些行政障礙。因此，一旦我們讓他們有更多可以分享的內容，我們將非常樂意分享。

Yes, that was great. Thanks so much, Rob. And then and then, Scott, one for you on, I guess, kind of on some of the legislation kind of guidelines but out there. So the first is on the biomarker legislation that you are obviously expanding private payer, commercial recoveries in kind of an ongoing effort for you. You have these biomarker laws that it really like kind of deepen your penetration possibly in that in that segment to produce the heavy lifting for you? So is it fair to say I mean, I think Halliburton, Colorado is going to be evaluating that for installation this year, I believe. So. Is that a tailwind or not? I guess?

是的，那太好了。非常感謝，羅布。然後，斯科特，我想，給你一個關於一些立法類指導方針的內容，但就在那裡。因此，第一個是關於生物標誌物立法，您顯然正在擴大私人付款人、商業追償，這對您來說是一項持續的努力。您擁有這些生物標記法則，它確實喜歡加深您在該領域的滲透，從而為您帶來繁重的工作？我的意思是，我認為科羅拉多州哈里伯頓今年將對其安裝進行評估，這是否公平？所以。這是順風還是逆風？我猜？

And then just secondly, I think I do see it as this new car concurrent on tissue and blood base testing guidelines for recommended guidelines for lung cancer. I mean, does that affect you at all just wondering if these things are maybe like drivers of performance like this year that wouldn't be affected or included, I mean, in this guidance?

其次，我認為我確實將這款新車視為與肺癌推薦指南的組織和血液基礎測試指南同時進行的。我的意思是，這是否會影響您，只是想知道這些事情是否可能像今年一樣不會受到影響或包含在本指南中？

Yes. Good morning, Kyle. Great questions. I'll start with the last definitely there's an opportunity for us there and the tailwind, especially on our IQ loan portfolio of the franchise where we offer to genomic blood-based test. And then our proprietary various stress tests where we measure a patient's immune immune system status or ability for the immune system to respond to that tumor for us, it does create an increased awareness and we have the most rapid turnaround times for those tests. And I think some aren't quite aware, we actually do offer tissue testing to our biopharma partners. So that fits squarely kind of in our wheelhouse. I think on the individual state biomarker builds, I think Robin may be the best to provide an update on that, and I'll turn it over to her.

是的。早安，凱爾。很好的問題。我將從最後一個開始，這對我們來說絕對是一個機會和順風，特別是在我們提供基於血液的基因組測試的特許經營商的智商貸款組合方面。然後我們專有的各種壓力測試，我們測量患者的免疫系統狀態或免疫系統對我們的腫瘤作出反應的能力，它確實提高了認識，並且我們對這些測試有最快的周轉時間。我認為有些人不太清楚，我們實際上確實為我們的生物製藥合作夥伴提供組織測試。所以這非常適合我們的駕駛室。我認為在個人狀態生物標誌物的構建上，我認為羅賓可能是提供最新資訊的最佳人選，我會將其轉交給她。

Yes. And it's a great question. And there have been a lot of biomarker bills passed over the last couple of years. Louisiana, Arizona, Illinois, leading the way you're right, Colorado is considering it in this legislative session. We really look at this as a it may be a door opener. It's they are focused on the payers and trying to help get a more rapid payer coverage for tests that have been proven and have Medicare coverage or other other data reviews that prove the test has clinical utility and our team are actively working with health plans in the states that they built have already gone live and we'll see how that turns out. The big question is, most of them have not most of the states have not yet implemented the regulations that will dictate how they will require the coverage and how it will be enforced. So it's really a work in progress, but it's something we've done tracking very, very closely.

是的。這是一個很好的問題。過去幾年通過了許多生物標記法案。路易斯安那州、亞利桑那州、伊利諾伊州領先，科羅拉多州正在本次立法會議上考慮這一點。我們確實認為這可能是個開門紅。他們專注於付款人，並試圖幫助付款人更快地覆蓋已被證明且具有醫療保險覆蓋範圍或其他數據審查的測試，證明該測試具有臨床實用性，我們的團隊正在積極與健康計劃合作他們建立的狀態已經上線，我們將看看結果如何。最大的問題是，大多數州還沒有實施規定，這些規定將規定他們如何要求承保以及如何執行。所以這確實是一項正在進行的工作，但我們已經非常非常密切地跟踪它。

Okay. Actually, on that note, would you not sense, interesting guidelines are so important for the private payer commercial payer segment. Would this kind of you know, reduce the need to get into guidelines or kind of even the case that kind of pushed by you?

好的。實際上，在這一點上，您是否沒有意識到，有趣的指導方針對私人付款人商業付款人細分市場非常重要。您是否知道這種情況，從而減少制定指導方針或甚至是您推動的案件的需要？

Yes. It's a really good question. And I think we're approaching it as if it won't negate it. I think for us I'm getting into guidelines, whether that's NCCNACCP. inflation or ARM, that really would be a great tailwind for us. As we've stated before, ACCP., which is the chest guidelines, would be the most appropriate for us. None of this is where developing and presenting the best data possible. And as you get that out there and enabling and empowering physicians to make the right decisions, we've highlighted historically that chest or ACCP. has been delayed there behind. So they've made very few actual updates and for lung nodule management and lung cancer detection and diagnosis in the last couple of years. So if we can agree that they're behind. It's really a matter of when do they catch up and then how broadly do they go in updating those guidelines and NCCN, right, is going to be slightly more on the treatment guidance front, which could benefit us on our IQ long. So we're going to continue to fuel that by funding studies for producing and publishing the best and highest quality data possible and working with those private payers to make certain that if they have questions, we're answering those questions with data.

是的。這是一個非常好的問題。我認為我們正在接近它，就好像它不會否定它一樣。我認為對我們來說，我正在製定指導方針，無論是 NCCNACCP。通膨或ARM，這對我們來說確實是一個巨大的推動力。正如我們之前所說，ACCP，即胸部指南，將是最適合我們的。所有這些都不是開發和呈現最佳數據的地方。當您了解這一點並幫助醫生做出正確的決定時，我們在歷史上強調了胸部或 ACCP。已經被耽擱在那裡了。因此，在過去幾年中，他們在肺結節管理和肺癌檢測和診斷方面幾乎沒有進行任何實際更新。所以如果我們同意他們落後了。這實際上是一個問題，他們什麼時候能趕上，然後他們在多大程度上更新這些指南，NCCN，對，在治療指導方面會稍微多一些，這可能對我們的智商長期有利。因此，我們將繼續透過資助研究來產生和發布盡可能最好和最高品質的數據，並與這些私人付款人合作，以確保如果他們有疑問，我們將用數據回答這些問題，從而繼續推動這一進程。

Okay. That's great, Scott. And just one more before I hop off about the portfolio. The problem, though. So I think via the pipeline tests were not mentioned possibly at all in the prepared remarks. Maybe just start either update us on these tests like at the MRD tests or for appear anything on that? And then maybe like we should expect any any news or updates this year or next year, possibly from those assets?

好的。太棒了，斯科特。在我開始討論投資組合之前，先講一個。但問題是。所以我認為在準備好的評論中可能根本沒有提到通過管道測試。也許只是開始向我們更新這些測試（例如 MRD 測試）或在其中顯示任何內容？然後也許我們應該期待今年或明年有任何新聞或更新，可能來自這些資產？

Yes. Thanks, Kyle. Yes, just as a reminder, for everybody, we have three products in our in our pipeline now we have a primary immune response test, we're able to identify those patients that respond favorably to an immunotherapy regimen. We also have risk of recurrence, which is a pre-surgical resection, blood-based test, where we can identify those patients with the highest likelihood of recurrence. And then the MRD. would be our post surgical resection of blood-based tests where we can identify those patients with minimal residual disease who are also likely to recur, we believe will be the first company to have both the pre-surgical and post surgical blood draw that can help to identify those patients with the highest likelihood of recurrence and that those two tests would cover both kind of a multi-omics approach, both proteomic and genomic and given our prioritization of kind of progressing towards profitability.

是的。謝謝，凱爾。是的，提醒大家，我們的管道中有三種產品，現在我們有了初級免疫反應測試，我們能夠識別那些對免疫治療方案有良好反應的患者。我們也面臨復發風險，這是一種術前切除、基於血液的測試，我們可以識別那些復發可能性最高的患者。然後是 MRD。這將是我們手術切除後進行的基於血液的測試，我們可以識別那些有微小殘留疾病且也可能復發的患者，我們相信這將是第一家進行術前和術後抽血的公司，這可以幫助以確定那些復發可能性最高的患者，這兩項測試將涵蓋蛋白質組學和基因組學兩種多組學方法，並考慮到我們對盈利進展的優先考慮。

Kyle, we've slowed commercialization of those. So we're not planning on launching any of those three tests here in 2024. And I think everybody understands when you first launch a test and you have to build kind of that experience and that data, oftentimes, those are no pay test. And so for us, ensuring that we've got a path to reimbursement for those will help guide us in our time line in a timeline of commercialization. We'll continue to provide updates as we progress. I wouldn't anticipate hearing much on the risk of recurrence or primary immune response front, but we've already discovered developed and validated those. Those are still being offered for biopharmaceutical partners in a research use only basis on the MRD. projects though I fully expect we'll be providing updates here in the coming weeks and months as we continue to progress and collaborate with Memorial Sloan Kettering. They've been a tremendous partner and I think what you'll find is working together collaboratively. We believe that this is an engine that will enable us to fuel future growth and potentially add additional products. In addition to the MRD. product.

凱爾，我們已經放慢了這些產品的商業化速度。因此，我們不打算在 2024 年在這裡啟動這三項測試中的任何一項。我想每個人都明白，當你第一次啟動測試時，你必須建立某種體驗和數據，通常這些都是無償測試。因此，對我們來說，確保我們有一條報銷途徑將有助於指導我們商業化的時間表。隨著我們的進展，我們將繼續提供更新。我預計不會聽到太多關於復發風險或初級免疫反應方面的信息，但我們已經發現了這些內容的開發和驗證。這些仍然基於 MRD 僅供研究用途提供給生物製藥合作夥伴。儘管我完全希望隨著我們繼續取得進展並與紀念斯隆凱特琳合作，我們將在未來幾週和幾個月內在這裡提供更新。他們是一位出色的合作夥伴，我認為您會發現他們正在共同努力。我們相信，這是一個引擎，將使我們能夠推動未來的成長，並有可能增加更多的產品。除了MRD。產品。

Okay. These are some pipeline tests driving some of the biopharma revenue recently, or could that be upside going forward?

好的。這些是最近推動部分生物製藥收入的一些管道測試，或者未來可能會出現上升趨勢嗎？

It definitely is upside. Yes, we offer them trial. It really is dependent upon the different biopharmaceutical companies, their studies, the the critical questions, they're trying to answer that they think we can help them answer on it. It was not or those two were not the big drivers in the fourth quarter. We saw a tremendous amount of and continued interest in our on our really our treatment guidance portfolio so everything within IQ. one unit, the Gen-i strat DDPCR., the Genus draft NGS. and the Bear stress test those those were the big drivers of biopharma interest. And I think fair to say that early in 2024, it continues to be that way, a lot of interest, and we're making a lot of progress on numerous fronts with a handful of major biopharmaceutical companies.

這絕對是有好處的。是的，我們為他們提供試用。這確實取決於不同的生物製藥公司、他們的研究、關鍵問題，他們試圖回答他們認為我們可以幫助他們回答這個問題。事實並非如此，或者說這兩個人不是第四節的主要推動者。我們看到人們對我們的治療指導組合以及 IQ 中的一切都抱有巨大的持續興趣。一個單位，Gen-i strat DDPCR。，Genus 草案 NGS。和貝爾斯壓力測試這些是生物製藥興趣的主要驅動力。我認為公平地說，到 2024 年初，情況仍然如此，人們對此很感興趣，而且我們與少數主要生物製藥公司在許多方面取得了很大進展。

Yes. Thanks, Scott. Thanks, Robin.

是的。謝謝，斯科特。謝謝，羅賓。

Yes, thank you, Kyle.

是的，謝謝你，凱爾。

Tejas Savant, Morgan Stanley.

Tejas Savant，摩根士丹利。

Hi team. Good morning. Thanks for taking the questions. Madison on for to address. Some are wondering to start off with long diagnostics. Volume growing at about 65% in 2023 driven primarily by notify long testing. So wondering how sustainable you think that growth is as we start to see tougher comps year over year in 2024.

大家好。早安.感謝您提出問題。麥迪遜將致詞。有些人想從長期診斷開始。到 2023 年，銷量將成長約 65%，這主要是由通知長測試推動的。因此，隨著 2024 年我們開始看到逐年更艱難的競爭，您認為這種成長的可持續性如何。

Good morning, great. Great question. You know, for us, it's really a factor of the number of sales professionals we have on the opportunity within the territories we place them. And in some cases, whether that territory and sales consultant hasn't associate with them with six straight quarters of greater than 50% growth. That's really the bar that we've established and the goal that we've challenged the team to kind of we hit and exceed that growth performance on We stated that we hired 10 additional sales professionals at the end of 2023. The nice thing is based on our track record. We know that within about three months, they're going to be paying for themselves and contributing. And so we did that with that goal in mind, we really wanted them to be hired, trained onboarded out in the territory and fully capable of contributing as soon as possible in 2024 so we'll continue to invest in the sales and commercial channel expansion. Historically, we've hired approximately six sales reps per quarter, and obviously we shared that we had 10 in the fourth quarter. So we've demonstrated we can increase that number. We just want to be very mindful of that expense and cash burn and making certain that we set them up for an immediate or a near term return. And so we believe that we can continue to achieve those strong numbers you're spot on as we continue to grow the year over year comps become more and more challenging, and it would be really challenging if we were static and not continuing to expand the sales force, we still know that there's a number of pulmonologists that we haven't reached because of our limited coverage. And we also know that we're less than 1% penetrated into this market opportunity, and it's a massive opportunity. So we feel confidently, we can continue to grow, expand, invest in that commercial channel and that we'll see a return on that investment.

早上好，太好了。很好的問題。您知道，對我們來說，這實際上是我們在我們安置的區域內擁有的銷售專業人員數量的一個因素。在某些情況下，該地區和銷售顧問是否沒有將他們與連續六個季度超過 50% 的成長聯繫起來。這確實是我們設定的標準，也是我們向團隊提出的挑戰目標，要求我們達到並超越我們的成長表現。我們表示，我們將在 2023 年底額外聘用 10 名銷售專業人員。好的事情是基於我們的記錄。我們知道，大約三個月內，他們將收回成本並做出貢獻。因此，我們懷著這個目標做到了這一點，我們真的希望他們能夠被雇用，在該地區接受培訓，並完全有能力在 2024 年盡快做出貢獻，因此我們將繼續投資於銷售和商業管道擴張。從歷史上看，我們每季僱用了大約 6 名銷售代表，顯然我們在第四季度僱用了 10 名銷售代表。所以我們已經證明我們可以增加這個數字。我們只是想非常注意這筆費用和現金消耗，並確保我們為它們設定立即或短期回報。因此，我們相信，隨著我們逐年持續成長，我們可以繼續實現您所看到的強勁數字，而競爭變得越來越具有挑戰性，如果我們保持靜態而不繼續擴大規模，那將非常具有挑戰性。對於銷售人員來說，我們仍然知道，由於我們的覆蓋範圍有限，我們還沒有聯繫到許多肺科醫生。我們也知道，我們對這個市場機會的滲透率不到 1%，但這是一個巨大的機會。因此，我們充滿信心，我們可以繼續發展、擴大和投資該商業管道，並且我們將看到投資回報。

Got it. Okay. That makes sense. And I think you previously talked about an interim analysis for the altitude study. I was just wondering if we should be expecting to see some data from this sometime this year.

知道了。好的。這就說得通了。我想你之前談到了海拔研究的中期分析。我只是想知道我們是否應該期望在今年的某個時候看到一些數據。

Yes. So as a reminder, altitude is our prospective randomized trial for notify of this being conducted at a number of major academic institutions in North America, we implemented a DSMB Data Safety Management Board in 2023. And so the nice thing about that Madison is the interim analysis is really out of our control. The Data Safety Management Board will help guide that and direct that and they're meeting on a quarterly basis. So that select group of individuals have come together again in March. And then I believe June is the following meeting. And so I think we'll learn more as we progress through those meetings at this point in time, we're not anticipating an interim analysis on, but what I am able to share at this point in time is we have seen enrollment improvement and increase over the last 18 months kind of exiting the pandemic. And we've actually brought on a few additional academic institutions. So we feel confident that this is going to continue to be a meaningful data release. It's still just a question of when the Data Safety Management Board and the primary investigators deem that to be necessary. If we do work to do something this year, it would be at CHEST in that October, November timeframe. So we'll learn more and you can expect a greater insight into that in the following earnings call.

是的。提醒一下，Altitude 是我們在北美一些主要學術機構進行的前瞻性隨機試驗，我們在 2023 年實施了 DSMB 資料安全管理委員會。所以麥迪遜的好處是中期分析確實超出了我們的控制範圍。資料安全管理委員會將幫助指導並指導這項工作，他們每季舉行一次會議。因此，這群經過挑選的人在三月再次聚集在一起。然後我相信六月是下一次會議。因此，我認為，隨著我們在這些會議上取得進展，我們會了解到更多信息，我們預計不會進行中期分析，但我目前能夠分享的是，我們已經看到入學率有所改善，並且過去18 個月的成長，算是擺脫了疫情。我們實際上也建立了一些額外的學術機構。因此，我們相信這將繼續是一次有意義的數據發布。這仍然只是資料安全管理委員會和主要調查人員何時認為有必要的問題。如果我們今年確實要做某事，那就是在 10 月、11 月的時間範圍內的 CHEST。因此，我們將了解更多信息，您可以在接下來的財報電話會議中更深入地了解這一點。

Got it. That makes sense. Thanks so much for your time, guys. I'll hand it over.

知道了。這就說得通了。非常感謝您抽出時間，夥計們。我會把它交給你。

Great. Thanks, Madison.

偉大的。謝謝，麥迪遜。

That concludes today's question-and-answer session. I'd like to turn the call back to Scott Hutton for closing remarks.

今天的問答環節到此結束。我想將電話轉回給斯科特·赫頓（Scott Hutton），讓其致閉幕詞。

Thank you, operator. We've worked long and hard to build the best pulmonology focused sales team in diagnostics and believe that this is just the beginning of our growth and we just scratched the surface with less than 1% penetration of this addressable market with first-mover status in lung nodule management and an ever-increasing body of robust clinical data. We're building the momentum we've already created as we increase our clinical and payer adoption in this extremely large and underserved population ultimately, it's all about healthcare professionals and the patients they treat. And we believe in our ability to make a more significant impact in the future.

謝謝你，接線生。我們經過長期努力，建立了診斷領域最好的專注於肺病學的銷售團隊，並相信這只是我們成長的開始，我們只是觸及了表面，在這個可尋址市場的滲透率還不到1%，在肺結節管理和不斷增加的可靠臨床數據。我們正在建立我們已經創造的勢頭，因為我們在這個極其龐大且服務不足的人群中增加了我們的臨床和付款人採用率，最終，這一切都與醫療保健專業人員和他們治療的患者有關。我們相信我們有能力在未來產生更重大的影響。

This year, we delivered 65% lung diagnostic test volume growth. Solid return to growth in our biopharma services business, expanded our sector-leading gross margins to the mid 70s and improved adjusted EBITDA by 24% at bad Essex. We have a culture of teamwork, quality and execution and constantly work to deliver on our goals to increase our reach and adoption and improve our operational effectiveness and efficiencies on our path to profitability. 2024 is a pivotal year of execution, and we look forward to updating you on our continued progress and success on the next earnings call. Thank you.

今年，我們的肺部診斷測試量增加了 65%。我們的生物製藥服務業務穩步恢復成長，將業界領先的毛利率擴大到 70 年代中期，並將 Bad Essex 的調整後 EBITDA 提高了 24%。我們擁有團隊合作、品質和執行的文化，並不斷努力實現我們的目標，以擴大我們的影響力和採用率，並提高我們的營運有效性和效率，以實現盈利。 2024 年是執行的關鍵一年，我們期待在下一次財報電話會議上向您通報我們的持續進展和成功情況。謝謝。

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

今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接。