Biodesix Inc (BDSX) 2023 Q1 法說會逐字稿

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

美好的一天，感謝您的耐心等待，歡迎參加 Biodesix 2023 年第一季度收益電話會議。 （操作員指示）今天的會議正在錄製。我現在想將會議交給今天的發言人，Biodesix 投資者關係部的 Chris Brinzey。請繼續。

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

謝謝接線員，大家下午好。感謝您今天加入我們討論 Biodesix 2023 年第一季度的業務亮點和財務業績。今天的電話會議將由首席執行官斯科特·赫頓 (Scott Hutton) 主持。首席財務官羅賓·哈珀·考伊 (Robin Harper Cowie) 也將加入他的行列。準備好發言後，我們將開始問答環節。今天電話會議的錄音和網絡廣播重播也將在線提供，詳情請參閱本次電話會議的新聞稿。

Today, we issued a press release announcing our business highlights and financial results for the first quarter 2023. A copy of the release can be found on the Investor Relations page of the company 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 Biodesix's industry.

今天，我們發布了一份新聞稿，宣布了 2023 年第一季度的業務亮點和財務業績。該新聞稿的副本可以在公司網站的投資者關係頁面上找到。由於市場趨勢變化、需求減少以及 Biodesix 行業的競爭性質，實際事件或結果可能與預測存在重大差異。

Such forward-looking statements and their implications involve known and unknown risk, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. The 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 ending December 31, 2022 filed with the Securities and Exchange Commission on March 6, 2023, as well as on Form 10-Q filed today for the first quarter of 2023 as applicable.

此類前瞻性陳述及其影響涉及已知和未知的風險、不確定性以及其他可能導致實際結果或業績與預測存在重大差異的因素。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，包括風險因素部分以及公司向證券和證券交易委員會提交的截至 2022 年 12 月 31 日的 10-K 表格年度報告中其他部分討論的風險和不確定性。交易所委員會於 2023 年 3 月 6 日以及今日提交的 2023 年第一季度適用的 10-Q 表格中。

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.

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。

I would now like to turn the call over to Scott Hutton, Chief Executive Officer. Scott?

我現在想將電話轉給首席執行官斯科特·赫頓 (Scott Hutton)。斯科特？

Thank you, Chris. Biodesix is a patient-centric, mission-driven lung disease diagnostic company, with a mission to unite physicians, patients and biopharma to transform the standard of care and improve outcomes with personalized diagnostics.

謝謝你，克里斯。 Biodesix 是一家以患者為中心、以使命為導向的肺部疾病診斷公司，其使命是將醫生、患者和生物製藥公司聯合起來，通過個性化診斷改變護理標準並改善結果。

At Biodesix, we've built a comprehensive portfolio of precision diagnostic tests to support clinical decision-making across the lung cancer continuum of care. Our core lung diagnostic testing portfolio ranges from initial risk assessment of lung nodules with the Nodify Lung testing strategy to post-cancer diagnosis, treatment guidance and monitoring, with the IQLung testing strategy. Nodify Lung consists of two blood-based proteomic tests, Nodify CDT and Nodify XL2, which are used by physicians to assess the risk of malignancy of a lung nodule.

在 Biodesix，我們建立了全面的精準診斷測試組合，以支持整個肺癌連續護理過程中的臨床決策。我們的核心肺部診斷測試產品組合涵蓋從使用 Nodify Lung 測試策略對肺結節進行初始風險評估到使用 IQLung 測試策略進行的癌症後診斷、治療指導和監測。 Nodify Lung 由兩種基於血液的蛋白質組學測試組成：Nodify CDT 和 Nodify XL2，醫生用它們來評估肺結節的惡性風險。

IQLung consists of three blood-based tests, the GeneStrat NGS genomic test, the GeneStrat ddPCR-targeted genomic test, and the VeriStrat proteomic test. Offered as options within the IQ long testing strategy, these three tests are used to inform treatment decisions and monitor for the rise of resistance mutations while patients are on therapy.

IQLung 包括三種基於血液的測試：GeneStrat NGS 基因組測試、GeneStrat ddPCR 靶向基因組測試和 VeriStrat 蛋白質組測試。這三種測試作為智商長期測試策略中的選項提供，用於為治療決策提供信息，並在患者接受治療時監測耐藥突變的增加。

All five of our core lung diagnostic tests are covered by Medicare, and we believe we're the only diagnostic company with five on-market tests for lung cancer, all with Medicare coverage.

我們的所有五項核心肺部診斷測試均由醫療保險承保，我們相信我們是唯一一家擁有五項市場上肺癌測試且全部都在醫療保險範圍內的診斷公司。

Throughout the quarter, we've continued to make excellent progress, and I'm pleased with the start to the year. Looking at our financial performance, we reported total revenue of $9.1 million for the first quarter 2023, which represents growth of 38% compared to the same period a year ago.

在整個季度中，我們繼續取得了出色的進展，我對今年的開局感到滿意。從我們的財務業績來看，我們報告 2023 年第一季度的總收入為 910 萬美元，與去年同期相比增長了 38%。

The quarter was again highlighted by the impressive growth of our core lung diagnostic testing business, which generated revenue of $8.6 million, reflecting approximately 86% year-over-year growth. We're exceptionally pleased with not only the growth in core lung diagnostic testing volumes but in the accelerating ramp of that growth.

我們核心肺部診斷測試業務的驚人增長再次凸顯了本季度的亮點，該業務產生了 860 萬美元的收入，同比增長約 86%。我們不僅對核心肺部診斷檢測量的增長感到非常滿意，而且對這種增長的加速增長感到非常滿意。

Core lung diagnostics' quarterly test volumes increased by 78% compared to the first quarter of 2022, the highest quarterly year-over-year growth in nearly two years, primarily driven by our Nodify Lung testing volumes. Following the seasonality seen in the beginning of the first quarter, our sales team has benefited from being in front of physicians and care teams on a day-to-day basis, as well as an increasing number of peer-to-peer physician educational events.

與 2022 年第一季度相比，Core Lung Diagnostics 的季度測試量增長了 78%，這是近兩年來最高的季度同比增長，這主要是由我們的 Nodify Lung 測試量推動的。繼第一季度初出現的季節性之後，我們的銷售團隊受益於每天面對醫生和護理團隊以及越來越多的同行醫生教育活動。

Importantly, the momentum seen through the end of the first quarter has continued, and we're pleased with the start to the second quarter. In addition to the growth in volumes driven by our sales team, broadening reimbursement coverage remains an important part of our growth strategy.

重要的是，第一季度末的勢頭仍在持續，我們對第二季度的開始感到滿意。除了我們的銷售團隊推動的銷量增長之外，擴大報銷範圍仍然是我們增長戰略的重要組成部分。

Building on the recent announcements of the first four private payer coverage policies for the Nodify XL2 test, we're making excellent progress and expect to have additional updates for you in the coming months and quarters, including the anticipated first private coverage for our Nodify CDT test expected later this year.

基於最近宣布的 Nodify XL2 測試的前四項私人付款人承保政策，我們正在取得巨大進展，並預計在未來幾個月和幾個季度為您提供更多更新，包括預期的 Nodify CDT 首個私人承保預計今年晚些時候進行測試。

To further support our clinical adoption and reimbursement, we also anticipate several updates on clinical studies we're conducting that will build upon and support the clinical utility of our Nodify Lung and IQLung testing strategies. Specifically, we anticipate sharing additional data and updates from the ORACLE study evaluating the performance of Nodify testing and updated data from our INSIGHT study, assessing the clinical effectiveness of VeriStrat, our proprietary blood-based proteomic immune profiling test.

為了進一步支持我們的臨床採用和報銷，我們還預計我們正在進行的臨床研究會有一些更新，這些更新將建立在我們的 Nodify Lung 和 IQLung 測試策略的臨床實用性基礎上並支持它們的臨床實用性。具體來說，我們預計會分享 ORACLE 研究中評估 Nodify 測試性能的額外數據和更新，以及我們 INSIGHT 研究中的更新數據，評估 VeriStrat（我們專有的基於血液的蛋白質組免疫分析測試）的臨床有效性。

Moving to our biopharmaceutical partnerships and service business, in the first quarter, we reported revenue of $411,000 for the quarter, which continued to be impacted by timelines for existing and new agreements resulting from delayed enrollment and clinical trials.

轉向我們的生物製藥合作夥伴關係和服務業務，第一季度，我們報告該季度的收入為 411,000 美元，該收入繼續受到因註冊和臨床試驗延遲而導致的現有和新協議時間表的影響。

On a positive note, we continue to have a strong backlog, and we ended the quarter with $9.1 million under contract, but not yet recognized. While we're encouraged by the continued strength in the backlog, we assume the challenges our pharma partners are experiencing will remain for the next few quarters as projects slow, and in some cases are delayed beyond our originally expected timelines.

從積極的方面來看，我們仍然有大量積壓訂單，本季度末我們的合同金額為 910 萬美元，但尚未確認。雖然我們對積壓的持續強勁感到鼓舞，但我們認為，隨著項目進展緩慢，我們的製藥合作夥伴所面臨的挑戰將在未來幾個季度持續存在，並且在某些情況下會延遲到超出我們最初預期的時間表。

Longer term, we believe our ongoing efforts and advancements in explainability and transparent AI provide what we believe are unique insights and clarity to healthcare professionals and biopharmaceutical and academic research teams by providing the ability to identify key biological mechanisms, driving specific outcomes for patient subgroups that may require a different approach or different treatment.

從長遠來看，我們相信我們在可解釋性和透明人工智能方面的持續努力和進步，通過提供識別關鍵生物機制的能力，為醫療保健專業人員、生物製藥和學術研究團隊提供我們認為獨特的見解和清晰度，推動患者亞組的特定結果，可能需要不同的方法或不同的治療。

I've said it before and cannot reiterate it enough, lung cancer kills more people in the United States annually than the next three deadliest cancers combined, breast, prostate, and colon cancer. Time matters when treating these patients. We pride ourselves on Biodesix's ability to discover, develop, and commercialize a broad range of tests that can quickly provide critical results and insights back to healthcare professionals and care teams with best-in-class turnaround times for all test to help improve patient outcomes.

我之前已經說過，而且再重申一遍，在美國每年因肺癌死亡的人數比緊隨其後的三種最致命癌症（乳腺癌、前列腺癌和結腸癌）的總和還多。治療這些患者時，時間很重要。我們為 Biodesix 發現、開發和商業化各種測試的能力感到自豪，這些測試可以快速向醫療保健專業人員和護理團隊提供關鍵結果和見解，並為所有測試提供一流的周轉時間，以幫助改善患者的治療結果。

With our strengthened financial position, along with the products and team in place, we're confident in our ability to drive continued strong test volume and revenue growth in 2023 and beyond.

憑藉我們增強的財務狀況以及到位的產品和團隊，我們對在 2023 年及以後推動持續強勁的測試量和收入增長的能力充滿信心。

Now let me turn it over to Robin to review the first-quarter 2023 financial performance. Robin?

現在讓我請 Robin 回顧一下 2023 年第一季度的財務業績。羅賓？

Thanks, Scott. First-quarter total revenue was $9.1 million, a 38% increase over the prior year. Core lung diagnostic revenue in the first quarter was $8.6 million compared to $4.6 million for the first quarter of 2022, an increase of 86% over the prior year.

謝謝，斯科特。第一季度總收入為 910 萬美元，比上年增長 38%。第一季度核心肺診斷收入為 860 萬美元，而 2022 年第一季度為 460 萬美元，同比增長 86%。

In the quarter, we recorded total test volumes of approximately 7,600 versus approximately 4,300 for the first quarter 2022, a 78% increase. The growth in test volume was primarily driven by our Nodify Lung nodule testing, which includes Nodify XL2 and Nodify CDT tests. The difference in growth rates between volume and revenue was primarily driven by Medicare coverage for Nodify CDT achieved in the second quarter 2022.

本季度，我們記錄的總測試量約為 7,600 次，而 2022 年第一季度的測試量約為 4,300 次，增長了 78%。測試量的增長主要是由我們的 Nodify 肺結節測試推動的，其中包括 Nodify XL2 和 Nodify CDT 測試。銷量和收入之間的增長率差異主要是由於 2022 年第二季度實現的 Nodify CDT 醫療保險覆蓋所致。

Biopharmaceutical services revenue was $411,000 in the quarter compared to $915,000 in the first quarter 2022, a decrease of 55%. As a reminder, this business can fluctuate due to several factors, including contract timing and project execution, but in this instance, reflects the continued delays of enrollment in prospective clinical trials to complete the projects and recognized revenue.

該季度生物製藥服務收入為 411,000 美元，較 2022 年第一季度的 915,000 美元下降 55%。提醒一下，該業務可能會因合同時間和項目執行等多種因素而波動，但在這種情況下，反映了為完成項目和確認收入而參加前瞻性臨床試驗的持續延遲。

As Scott mentioned, we ended the first quarter of 2023 with $9.1 million contracted, but not yet recognized as revenue. These dollars are tied to multiple agreements with different timelines and will be recognized as these projects are executed. COVID testing revenue in the quarter was negligible and as we have guided, should not be modeled to contribute to revenue in 2023.

正如斯科特提到的，我們在 2023 年第一季度結束時簽訂了 910 萬美元的合同，但尚未確認為收入。這些美元與具有不同時間表的多個協議掛鉤，並將在這些項目執行時得到確認。本季度的新冠病毒檢測收入可以忽略不計，並且正如我們所指導的那樣，不應對其進行建模以貢獻 2023 年的收入。

In connection with the expiration of the public health emergency declaration today, May 11, the company will no longer provide COVID-19 diagnostic testing services commercially. Gross margin percentage in the first quarter of 2023 was 65% versus 51% in the prior year quarter. Current gross margin trends reflect the growth in our higher-margin core lung diagnostic testing business and receiving Medicare coverage for our Nodify CDT test. Gross margin as a percentage of revenue for the first quarter of 2023 compared to the prior year quarter also reflects the expected decrease in the lower-margin COVID testing revenue from a year ago.

鑑於今天（5 月 11 日）公共衛生緊急狀態聲明到期，該公司將不再提供商業性的 COVID-19 診斷測試服務。 2023 年第一季度的毛利率為 65%，而去年同期為 51%。目前的毛利率趨勢反映了我們利潤率較高的核心肺部診斷測試業務的增長以及我們的 Nodify CDT 測試的醫療保險覆蓋範圍。與去年同期相比，2023 年第一季度的毛利率佔收入的百分比也反映出利潤較低的新冠檢測收入較上年同期預計下降。

Looking to the remainder of 2023, we expect the overall gross margin percentage to continue to increase as a result of several factors, including the benefit of Medicare coverage for Nodify CDT tests, the benefit of recently announced commercial payer coverage decisions for Nodify XL2 as well as additional commercial coverage as we move through the year and the operational efficiencies resulting from the growth in volumes for all of our tests.

展望 2023 年剩餘時間，我們預計整體毛利率百分比將繼續增長，原因有幾個因素，包括 Nodify CDT 測試的醫療保險覆蓋的好處，以及最近宣布的 Nodify XL2 商業付款人覆蓋決定的好處作為我們全年的額外商業覆蓋範圍以及我們所有測試量增長帶來的運營效率。

Overall operating expense, excluding direct costs and expenses was $22.3 million in the first quarter 2023 compared to $17.8 million for the same period of 2022. The increase in operating expense for the quarter is primarily driven from increased sales and marketing expense, and the hiring of sales team members, increased travel-related costs due to the return to pre-pandemic level access to physicians and increases in other employee-related costs.

2023 年第一季度的總體運營費用（不包括直接成本和費用）為 2230 萬美元，而 2022 年同期為 1780 萬美元。該季度運營費用的增加主要是由於銷售和營銷費用的增加以及招聘銷售團隊成員、由於恢復到大流行前的醫生水平而導致的差旅相關成本增加以及其他員工相關成本的增加。

Operating expense for the first quarter of 2023 includes $2.3 million in non-cash stock compensation expense as compared to $1.3 million during the first quarter of 2022. Net loss for the first quarter of 2023 was $18.7 million compared to a $15.6 million net loss for the same period of 2022. The increase in net loss for the quarter included the increase in non-cash stock-based compensation, an increase of $1.3 million in interest expense, primarily associated with the Perceptive term loan facility, and the increase in costs from the expansion of our commercial team and efforts.

2023 年第一季度的運營費用包括 230 萬美元的非現金股票補償費用，而 2022 年第一季度為 130 萬美元。2023 年第一季度的淨虧損為 1870 萬美元，而 2023 年第一季度的淨虧損為 1560 萬美元。與 2022 年同期相比。本季度淨虧損的增加包括非現金股票補償的增加、利息支出增加 130 萬美元（主要與 Perceptive 定期貸款便利相關）以及擴大我們的商業團隊和努力。

We ended the quarter with $25.3 million in unrestricted cash and cash equivalents as compared to $43.1 million in unrestricted cash and cash equivalents at the end of 2022, a decrease of $17.8 million, which includes the scheduled milestone payment of $2.2 million paid in January 2023 to Integrated Diagnostics, an annual royalty payment of $0.7 million.

截至本季度末，我們的非限制性現金和現金等價物為 2530 萬美元，而 2022 年底的非限制性現金和現金等價物為 4310 萬美元，減少了 1780 萬美元，其中包括 2023 年 1 月支付的 220 萬美元的預定里程碑付款Integrated Diagnostics，每年支付 70 萬美元的特許權使用費。

After considering these among other operating items, our cash burn for the quarter for all non-financing activities was approximately $12.6 million. We remain focused on revenue growth and driving additional cost savings measures, primarily in areas that do not drive near-term revenue growth that will positively impact 2023 as we move through the year.

考慮到這些以及其他運營項目後，我們本季度所有非融資活動的現金消耗約為 1260 萬美元。我們仍然專注於收入增長和推動額外的成本節約措施，主要是在那些不會推動短期收入增長的領域，而這些增長將對 2023 年產生積極影響。

Turning now to our 2023 guidance, we are maintaining the guidance provided last quarter of total revenue of $52 million to $55 million. Our guidance assumes continued strong year-over-year growth in our core lung diagnostic testing business, broader reimbursement of our five on-market tests, as well as modest expected growth in our biopharmaceutical services business.

現在轉向我們的 2023 年指導，我們維持上季度提供的總收入 5200 萬至 5500 萬美元的指導。我們的指導假設我們的核心肺部診斷測試業務持續強勁的同比增長，我們五項市場測試的更廣泛的報銷，以及我們的生物製藥服務業務的適度預期增長。

Our guidance does not project any COVID-19 revenue for 2023. The midpoint of this guidance represents approximately 60% annual revenue growth as compared to prior-year core long and biopharmaceutical services revenue.

我們的指引並未預測 2023 年的任何 COVID-19 收入。該指引的中點代表與上一年核心長期和生物製藥服務收入相比，年收入增長約 60%。

Now let me turn it back to Scott. Scott?

現在讓我把它轉回給斯科特。斯科特？

Thanks, Robin. In closing, I would like to thank all Biodesix teammates for their belief in and dedication to the Biodesix mission, vision, and culture, which revolves around our collective commitment and daily contributions to positively impact patients' lives. In so doing, we have established an exceptionally strong double-digit growth trajectory driven by our lung-focused sales team.

謝謝，羅賓。最後，我要感謝所有 Biodesix 團隊成員對 Biodesix 使命、願景和文化的信念和奉獻，這些使命、願景和文化圍繞著我們對積極影響患者生活的集體承諾和日常貢獻。通過這樣做，我們在以肺部為中心的銷售團隊的推動下建立了異常強勁的兩位數增長軌跡。

We are expanding reimbursement of our on-market tests with multiple coverage decisions from Medicare and private payers that we anticipate will contribute to our 2023 growth. Supporting this effort, we continue to successfully expand the growing body of clinical data to support the clinical utility of all five of our core lung diagnostic tests. We have established strong gross margins, which continue to improve with the scaling of our core lung diagnostic testing and reimbursement. And we are focusing on near-term revenue drivers with a cost-disciplined approach.

我們正在通過 Medicare 和私人付款人的多項承保決定擴大對市場測試的報銷，我們預計這將有助於我們 2023 年的增長。為了支持這一努力，我們繼續成功擴展不斷增長的臨床數據，以支持我們所有五種核心肺部診斷測試的臨床實用性。我們已經建立了強勁的毛利率，並且隨著我們核心肺部診斷測試和報銷規模的擴大，毛利率繼續提高。我們正通過嚴格控製成本的方法來關注短期收入驅動因素。

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

這樣，我會將電話轉給接線員詢問問題。

(Operator Instructions) Andrew Brackmann, William Blair.

（操作員說明）安德魯·布拉克曼、威廉·布萊爾。

Hi, everyone. This is Dustin on the line for Andrew. Thanks for taking our questions. First of all, just asking about the trends you're seeing recently thus far in the second quarter in terms of core lung volumes and ASPs and maybe what are some expectations on pacing for the rest of this year?

大家好。我是達斯汀，正在接聽安德魯的電話。感謝您回答我們的問題。首先，請問您在第二季度迄今為止在核心肺容量和平均售價方面看到的趨勢，以及對今年剩餘時間的節奏的一些預期是什麼？

Yeah. Hey, Dustin, good to hear from you. Thanks for joining. Great question. Q2 is consistent with Q1. All of our sales professionals have access to accounts, physicians are back treating those patients that they desire to treat and were last able to do so on a priority basis, pre-pandemic. So they're back out identifying those patients with a high risk of lung cancer. And so we feel good about that. That was one of the challenges throughout the pandemic, as you know, it was really ensuring that we had continued open access to physicians.

是的。嘿，達斯汀，很高興收到你的來信。感謝您的加入。很好的問題。 Q2 與 Q1 一致。我們所有的銷售專業人員都可以訪問賬戶，醫生正在重新治療他們想要治療的患者，並且最後能夠在大流行前優先治療。因此，他們不再識別那些患有肺癌高風險的患者。所以我們對此感覺良好。正如您所知，這是整個大流行期間面臨的挑戰之一，這實際上是確保我們能夠繼續向醫生開放。

Secondarily, what we're finding is that physicians' offices and schedules are full. So those patients that might have had a co-morbidity, were immunocompromised, or at risk, and told to stay home during the pandemic, what we're hearing and seeing is that those patients are back in clinic following up with physicians.

其次，我們發現醫生的辦公室和日程都滿了。因此，那些可能患有合併症、免疫功能低下或處於危險之中並被告知在大流行期間呆在家裡的患者，我們聽到和看到的是，這些患者回到診所接受醫生的隨訪。

And so for us, we look at it as a green light. Our talented sales force is out supporting those physicians. They're collaborating and we think we can maintain and continue to build upon the growth trajectory and successes that we've had. That momentum really will positively impact those gross margins, especially as Robin said, now that we're stopping all COVID testing.

所以對我們來說，我們將其視為綠燈。我們才華橫溢的銷售團隊正在為這些醫生提供支持。他們正在合作，我們認為我們可以保持並繼續發展我們已經取得的增長軌跡和成功。這種勢頭確實會對毛利率產生積極影響，特別是正如羅賓所說，現在我們正在停止所有新冠病毒測試。

So we really hope, by year-end, that we're back to those pre-pandemic levels of low 70% on the gross margins and continuing to have strong double-digit growth on our core lung diagnostic portfolio.

因此，我們真心希望到年底，我們的毛利率能回到大流行前 70% 的低水平，並繼續在我們的核心肺部診斷產品組合上實現兩位數的強勁增長。

From an ASP perspective, our average sales price by product has been very consistent. As you know, Medicare accounts for about 60% of the population. So with the Medicare coverage for each, that really drives the majority of the payments. I would anticipate, over the course of the year as we start to gain more and more private payer coverage in the -- for the Nodify franchise, that we can see some modest upticks. But really the biggest driver of ASP is -- at least in the lung disease space is Medicare.

從平均售價的角度來看，我們按產品的平均銷售價格非常一致。如您所知，醫療保險覆蓋了大約 60% 的人口。因此，隨著醫療保險的覆蓋，這確實推動了大部分付款。我預計，在這一年中，隨著我們開始獲得越來越多的私人付款人覆蓋——對於 Nodify 特許經營權，我們可以看到一些適度的上升。但實際上 ASP 的最大驅動力是——至少在肺部疾病領域是醫療保險。

Got it. Thanks for that. And then maybe just a related question on your recently expanded sales force. How are you guys measuring effectiveness there? And do you think the current level of sales reps now gives you a good level of growing your core lung franchise this year and next year?

知道了。感謝那。然後也許只是關於您最近擴大的銷售隊伍的相關問題。你們如何衡量那裡的有效性？您認為目前的銷售代表水平是否能讓您在今年和明年發展您的核心肺特許經營業務？

Yeah, it's a great question. Again, as a first mover in this space, we really feel like we're out informing, educating, and empowering physicians to order diagnostic testing to help this patient population. So there's definitely going to be some territories that scale faster and some that are more of a laggard where they're coming on later and they're waiting for additional clinical data.

是的，這是一個很好的問題。再說一次，作為這個領域的先行者，我們真的覺得我們正在向醫生提供信息、教育和授權，讓他們能夠進行診斷測試來幫助這個患者群體。因此，肯定會有一些領域擴展得更快，而另一些領域則比較落後，它們會稍後出現，並且正在等待更多的臨床數據。

So we feel that the sales force right now is appropriately positioned, we can continue to grow and scale with the sales team that we have. We really have yet to see a sales professional cap out or max out that territory and so we still think there's room to improve on those sales rep productivity numbers and metrics.

因此，我們認為現在的銷售隊伍定位合適，我們可以繼續擴大現有銷售團隊的規模。我們確實還沒有看到銷售專業人員達到或最大化該領域，因此我們仍然認為這些銷售代表的生產力數字和指標還有改進的空間。

One of the more recent changes that we've made in 2023 is we've begun bringing on kind of a junior sales rep or an associate sales consultant. The goal here really is to enable our top performers with larger territories that are growing exceptionally fast, continue to enable them to go out and prospect, bringing on new accounts, allowing the associate the opportunity to provide support and onboarding and follow up with those accounts.

我們在 2023 年所做的最新變化之一是我們開始聘請初級銷售代表或助理銷售顧問。這裡的目標實際上是讓我們的頂尖員工能夠擁有更大且增長速度極快的區域，繼續讓他們能夠走出去和尋找潛在客戶，帶來新客戶，讓員工有機會提供支持和入職並跟進這些客戶。

We think that this will allow us to focus on some cost-saving measures for the sales force, but it will also allow us to build a bench. So as we continue to grow and expand with the sales force, this will give us the pool of talent that's already been trained, already on-boarded that we can move into other territories as we get to kind of critical mass and are able to start cutting territories and focus on growth again. And additional cost savings with that is that will minimize recruiting fees and expenses in future months.

我們認為，這將使我們能夠專注於為銷售人員採取一些節省成本的措施，但它也將使我們能夠建立一個長凳。因此，隨著我們不斷發展和擴大銷售隊伍，這將為我們提供已經接受過培訓、已經入職的人才庫，當我們達到臨界規模並能夠開始時，我們可以進入其他領域削減領土並再次專注於增長。隨之而來的額外成本節省將最大限度地減少未來幾個月的招聘費用和開支。

So we feel good about the size of the sales force now. Any sales professional would always say they would rather have more resources than less. But we know that this is a really large market opportunity, and we've just begun this journey. So we'll continue to expand, but we want to do it mindfully and intentionally to ensure that we keep costs in check.

所以我們現在對銷售隊伍的規模感到滿意。任何銷售專業人士都會說，他們寧願擁有更多的資源，也不願擁有更少的資源。但我們知道這是一個非常大的市場機會，而我們才剛剛開始這一旅程。因此，我們將繼續擴張，但我們希望謹慎、有意識地這樣做，以確保控製成本。

Makes sense. Thanks, Scott. And then one more we have. Just wondering if you can give us an update on the VA contract grant. What is utilization like across all those five tests? And are CDT and XL2, are those being ordered together within the VA contract? Thank you.

說得通。謝謝，斯科特。然後我們還有一個。只是想知道您是否可以向我們提供有關 VA 合同撥款的最新信息。這五項測試的利用率如何？ CDT 和 XL2 是在 VA 合同中一起訂購的嗎？謝謝。

Yeah, great question and reminder for others. Last year, on the second half of the year, we announced that we've been added to the VA fee schedule for all five of our core lung diagnostic tests. And additional reminder, the VA had conducted a trial and an evaluation of Nodify utilizing Nodify CDT and Nodify XL2 together. That was an 11-site trial. And the results of that trial are what led to being added to the fee schedule.

是的，這是一個很好的問題，也是對其他人的提醒。去年下半年，我們宣布我們的所有五項核心肺部診斷測試已被添加到 VA 費用表中。另外提醒一下，VA 已經使用 Nodify CDT 和 Nodify XL2 一起對 Nodify 進行了試驗和評估。那是一次 11 個站點的試驗。該試驗的結果導致被添加到費用表中。

So we thought that was really indicative of performance. Their view on how those two tests could help them with this at-risk patient population. So being added to the fee schedule really gave us the ability to go out and focus on expanding across the VA. We have done that over the last few months and continue to focus on it.

所以我們認為這確實代表了性能。他們對這兩項測試如何幫助他們治療高危患者群體的看法。因此，加入費用表確實讓我們有能力走出去，專注於在整個 VA 範圍內擴張。我們在過去幾個月裡已經做到了這一點，並將繼續關注它。

But the one thing that we would remind everybody of, it really is an introduction. So each and every time sales rep makes a new call into that VA there, again, they're informing, educating, and empowering that physician to order the test. And it takes a little bit of time.

但我們要提醒大家的一件事是，這確實是一個介紹。因此，每次銷售代表向該 VA 撥打新電話時，他們都會再次通知、教育並授權該醫生進行測試。這需要一點時間。

On the second part of that question, Dustin, we haven't broken out any of the test ordering volumes and trends. I think it's easiest and safest to state that it's going to be Nodify CDT and XL2 that lead the way, and that we'll use acceptance on that fee schedule for the other three tests as an opportunity to introduce those over time.

關於該問題的第二部分，達斯汀，我們尚未公佈任何測試訂購量和趨勢。我認為最簡單、最安全的說法是，Nodify CDT 和 XL2 將引領潮流，我們將利用接受其他三個測試的費用表作為逐步引入這些測試的機會。

Got it. Thank you. That's all from us.

知道了。謝謝。這就是我們的全部。

Thanks, Dustin.

謝謝，達斯汀。

Go ahead, presenters.

繼續吧，主持人們。

I'm sorry. I was just thanking Dustin for his questions.

對不起。我只是感謝達斯汀提出的問題。

Alex Vukasin, Canaccord Genuity.

亞歷克斯·武卡辛 (Alex Vukasin)，Canaccord Genuity。

Hi. This is Alex Vukasin, on for Kyle Nixon. A very solid quarter guys. I was just curious if you could comment on the biopharma services revenue for the quarter. It seemed a little bit lower than usual. Can you just kind of discuss what you think the cadence of biopharma revenue might be? If you might face some continued headwinds over the year. Thanks.

你好。我是亞歷克斯·武卡辛 (Alex Vukasin)，替補凱爾·尼克松 (Kyle Nixon)。伙計們，這是一個非常堅實的季度。我只是好奇您是否可以評論本季度的生物製藥服務收入。看起來比平常低了一些。您能否討論一下您認為生物製藥收入的節奏可能是什麼？如果您今年可能面臨一些持續的逆風。謝謝。

Yeah, great to hear from you, Alex. Good question. You know, biopharma, over the last three years really has been significantly impacted. And a lot of that's due to clinical trial enrollment, whether it was clinical trials that stalled or paused during the pandemic or trials that were closed. What we've really been monitoring and watching for is that rebound and kind of the return to a normal cadence of events like we saw pre-pandemic,

是的，很高興收到你的來信，亞歷克斯。好問題。你知道，生物製藥在過去三年確實受到了重大影響。其中很大一部分原因是臨床試驗註冊，無論是在大流行期間停滯或暫停的臨床試驗還是關閉的試驗。我們真正一直在監測和關注的是反彈，以及某種程度的回歸正常的事件節奏，就像我們在大流行前看到的那樣，

We've seen it on numerous fronts. That's why we're so proud and excited to share the dollars under contract. In 2023, we've had a record number of requests for proposals come in thus far. So we think that that's a leading indicator that the biopharma business and interest remains high and is rebounding.

我們已經在很多方面看到了這一點。這就是為什麼我們如此自豪和興奮地分享合同下的美元。 2023 年，我們收到的提案請求數量創歷史新高。因此，我們認為這是一個領先指標，表明生物製藥業務和興趣仍然很高並且正在反彈。

Unfortunately, when you're dealing with a lot of those existing contracts that are pulling retrospective samples, it's really reliant on getting access to those samples. And so we believe all of those contracts that are in place are still top priorities for our biopharma partners. We think they'll continue to proceed. But we were a little disappointed in how we finished 2022 and how we've begun 2023.

不幸的是，當您處理大量提取追溯樣本的現有合同時，它實際上依賴於訪問這些樣本。因此，我們相信所有已簽訂的合同仍然是我們生物製藥合作夥伴的首要任務。我們認為他們會繼續進行。但我們對 2022 年的結束和 2023 年的開始感到有點失望。

Obviously, we would have liked to see more of those samples come in. But again, we think that that's still probably going to be a question mark going forward. I think there's an opportunity for us to improve, but the business has been lumpy for quite some time. We think the second half of 2023 is going to be exceptionally strong. And we fully expect this quarter Q2 to be an improvement upon Q1. So we think we'll continue to build and scale throughout the year.

顯然，我們希望看到更多的樣本。但我們再次認為，這可能仍然是一個問號。我認為我們有改進的機會，但業務已經很長一段時間不穩定了。我們認為 2023 年下半年將異常強勁。我們完全預計本季度第二季度將比第一季度有所改善。因此，我們認為我們將在全年繼續建設和擴大規模。

But most importantly, we're focused on building of the book of business, and we fully expect that book of business, which is a little over $9 million under contract, at this point in time, we expect that to continue to grow and it should be in the low double digits by next earnings call.

但最重要的是，我們專注於業務賬簿的建設，我們完全期望業務賬簿的合同價值略高於 900 萬美元，在這個時間點，我們預計它會繼續增長，並且到下一次財報電話會議時，該數字應該會達到低兩位數。

Got it. Thank you very much for all that great color. One last one for me. I'm just curious if you could kind of highlight the -- any upcoming readouts for INSIGHT, BEACON or any of your other studies that we can look forward to in the next few quarters? Thanks.

知道了。非常感謝您提供如此出色的顏色。最後一張給我。我只是好奇您是否可以強調一下——我們在接下來的幾個季度中可以期待的 INSIGHT、BEACON 或您的任何其他研究即將發布的讀數？謝謝。

Yeah. No, great question, Alex. As a data-driven diagnostic company, obviously, we're really excited to publish, present. And the more data we can get out there, the better off we're going to be. We just recently had a number of healthcare e-con abstract, and we'll be sharing those in a press release here soon. And it really goes to demonstrate and highlight the value of the Nodify testing strategy, the impact they can have at the hospital, and clinic level and really reinforcing the importance of intervening on those patients that need it most and prescribing a wait-and-watch approach for those patients that truly have a benign nodule.

是的。不，問得好，亞歷克斯。顯然，作為一家數據驅動的診斷公司，我們非常高興能夠發布、展示。我們獲得的數據越多，我們的生活就會越好。我們最近剛剛獲得了一些醫療保健電子商務摘要，我們很快將在新聞稿中分享這些摘要。它確實展示並強調了 Nodify 檢測策略的價值、它們可以在醫院和診所層面產生的影響，並真正強調了對最需要的患者進行干預並規定等待和觀察的重要性針對那些確實患有良性結節的患者的方法。

So we'll share more here in the coming days on that. And then as we head into a meeting and conference season, we will have a number of abstracts, presentations, and posters. We'll share more data on that as embargoes are lifted. We're excited to share that INSIGHT, which, as you may recall, is our study on VeriStrat, our proprietary immune profiling test. We are rapidly approaching the 5,000-patient mark. That was really our target.

因此，我們將在未來幾天在這里分享更多相關內容。然後，當我們進入會議季時，我們將有許多摘要、演示文稿和海報。隨著禁運的解除，我們將分享更多相關數據。我們很高興與大家分享這一見解，您可能還記得，這是我們對 VeriStrat（我們專有的免疫分析測試）的研究。我們正在迅速接近 5,000 名患者大關。這確實是我們的目標。

So by our next earnings call, we'll give an update on that, and I fully expect that we will have begin -- or begun to close some of those sites we'll begin wrapping up the INSIGHT trial. When we do so at that time, Alex, we'll give you a kind of a prospective outlook on when we'll publish, when we'll present, and what kind of data analysis will be looking at.

因此，在我們的下一次財報電話會議上，我們將對此進行更新，我完全預計我們將開始 - 或者開始關閉其中一些網站，我們將開始結束 INSIGHT 試驗。當我們那時這樣做時，亞歷克斯，我們會給你一個關於我們何時發布、何時呈現以及將關注什麼樣的數據分析的前瞻性展望。

And then also, as a reminder, we've begun shutting down the ORACLE study for Nodify and we have submitted that paper to be published. So we're hopeful here in the coming days and weeks, we'll have news to share on that paper publishing. But as a reminder, we did an interim analysis last year and at that point in time, we were able to show -- by utilizing the Nodify testing strategy, those physicians were able to decrease unnecessary interventions by nearly 70%.

另外，提醒一下，我們已經開始停止 ORACLE 對 Nodify 的研究，並且我們已經提交了要發表的論文。因此，我們希望在接下來的幾天和幾週內，我們能分享有關該論文出版的消息。但提醒一下，我們去年做了一項中期分析，當時我們能夠證明，通過利用 Nodify 測試策略，這些醫生能夠將不必要的干預減少近 70%。

So again, most importantly, taking tests that had really good validation data and now demonstrating that in a real-world environment, those tests are performing at an equal to or greater than performance rate. Those are the two main lookouts. ALTITUDE continues to enroll at a strong rate, but we don't have any interim analysis here in the next quarter or two.

因此，最重要的是，進行具有非常好的驗證數據的測試，現在證明在現實環境中，這些測試的執行速度等於或高於性能速度。這是兩個主要的瞭望台。 ALTITUDE 的入學率繼續強勁，但我們在接下來的一兩個季度沒有任何中期分析。

Great. Thank you so much. That's really helpful.

偉大的。太感謝了。這真的很有幫助。

Yeah, thank you, Alex.

是的，謝謝你，亞歷克斯。

[Tejas Steven], Morgan Stanley.

[Tejas Steven]，摩根士丹利。

[Yuko] on the call for Tejas. Thank you for taking our questions. Scott, with momentum building for our Nodify franchise, are you planning additional hires this year? And then also, your prior comments suggested your sales force is currently more focused on calling on physicians at academic centers. Does that still hold true? And if so, are you thinking about the right time to start putting greater commercial push into the community setting?

[Yuko] 呼籲光輝號。感謝您接受我們的提問。 Scott，隨著我們的 Nodify 特許經營業務不斷發展，您今年是否計劃增加員工？此外，您之前的評論表明您的銷售人員目前更專注於拜訪學術中心的醫生。這仍然成立嗎？如果是這樣，您是否正在考慮開始在社區環境中加大商業推動力的合適時機？

Yeah, great question, Yuko. Good to hear from you. We really are trying to be mindful of when and where we spend. I think like all other companies out there, we've got our eyes on a path to profitability that we haven't shared yet, but being a high-growth company and demonstrating the growth that we're demonstrating, we think it's a balance.

是的，很好的問題，優子。很高興聽到你的消息。我們確實在努力注意消費的時間和地點。我認為像所有其他公司一樣，我們已經著眼於我們尚未分享的盈利之路，但作為一家高增長公司並展示了我們正在展示的增長，我們認為這是一種平衡。

And so for us, what we don't want to do is blindly go out and hire sales professionals and assume that each and every territory will be the same and that it gives them an equal opportunity to not only ramp at the same rate, but that they can hit the same sales rep productivity numbers.

因此，對我們來說，我們不想做的是盲目地出去僱用銷售專業人員，並假設每個地區都是相同的，這給了他們平等的機會，不僅以相同的速度增長，而且他們可以達到相同的銷售代表生產力數字。

So if anything, we'll err on the side of proving it out first and trialing it before we bring on a fully burdened sales professional. We do have great successes in both the academic arena, but also in the community setting. And so yes, we do focus on both. There's a number of territories right now where I would say some of their strengths are actually focused on the community-based pulmonologists.

因此，如果有的話，我們寧願先證明它並進行試驗，然後再聘請一個負擔得起的銷售專業人員。我們確實在學術領域和社區環境中都取得了巨大的成功。所以，是的，我們確實關注這兩方面。我想說，現在在很多地區，他們的一些優勢實際上集中在社區肺科醫生身上。

But again, it's going to vary across territories based upon the different or at least the presence of different academic institutions, the referral networks, the different pathways. So for us, we really have to focus on all. But with our early entrants into some of our clinical trials and publishing, we have got strong support from some of the major academic institutions. So I wouldn't state that we would necessarily prioritize one over the other. A lot of it is a stepwise process, and as we balance that, I fully expect equal success across the board.

但同樣，由於不同的學術機構、推薦網絡和不同的途徑，不同地區的情況也會有所不同，或者至少是不同的存在。所以對我們來說，我們確實必須關注所有事情。但隨著我們早期進入一些臨床試驗和發表，我們得到了一些主要學術機構的大力支持。所以我不會說我們一定會優先考慮其中之一。其中很多都是一個逐步的過程，當我們平衡這一點時，我完全期望全面取得同樣的成功。

Great. Thank you for that. And then another quick question. With decision to discontinue COVID testing, are there any associated expenses or cost savings that we should be thinking about? So do we think about OpEx trends for the year?

偉大的。謝謝你。然後是另一個快速問題。在決定停止新冠病毒檢測後，我們是否應該考慮任何相關費用或成本節省？那麼我們是否考慮了今年的運營支出趨勢？

Not really. We had wound down our COVID testing over the last couple of quarters, as you saw, the test of COVID revenues really decreased. Part of our strategy with getting into COVID was to try not to invest heavily in that part of the business. We actually utilized the same technology that we use for our GeneStrat ddPCR testing and for our Nodify CDT testing.

並不真地。正如您所看到的，我們在過去幾個季度減少了新冠病毒測試，新冠病毒測試收入確實減少了。我們進入新冠疫情的戰略的一部分是盡量不要對這部分業務進行大量投資。實際上，我們使用了與 GeneStrat ddPCR 測試和 Nodify CDT 測試相同的技術。

So all of that equipment, the supplies, everything is now being used and all of the personnel are now being used in the growth of our core lung diagnostic. So really leveraging what we had built to help scale core lung over the next year.

因此，所有設備、用品、一切現在都在使用，所有人員現在都在用於我們核心肺部診斷的發展。因此，真正利用我們已經建立的東西來幫助在明年擴大核心肺的規模。

Great. Thank you so much.

偉大的。太感謝了。

Thanks, Yuko.

謝謝，優子。

Thank you so much. And presenters, there are no further questions at this time. Thank you for participating, presenters. This concludes today's conference call, and you may now disconnect. Have a great day.

太感謝了。主持人，目前沒有其他問題。謝謝各位主持人的參與。今天的電話會議到此結束，您現在可以掛斷電話了。祝你有美好的一天。