Personalis Inc (PSNL) 2025 Q2 法說會逐字稿

Ladies and gentlemen, greetings, and welcome to the Personalis second-quarter 2025 earnings conference call. (Operator Instructions) As a reminder, this conference is being recorded.

女士們、先生們，大家好，歡迎參加 Personalis 2025 年第二季財報電話會議。（操作員指示）提醒一下，本次會議正在錄音。

It is now my pleasure to introduce your host for today, Caroline Corner, Investor Relations. Please go ahead.

現在我很高興向大家介紹今天的主持人，投資者關係部的 Caroline Corner。請繼續。

Thank you, operator. Welcome to Personalis' second 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 Rich Chen, Chief Medical Officer and EVP, R&D.

謝謝您，接線生。歡迎參加 Personalis 2025 年第二季財報電話會議。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 Rich 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 US securities laws. 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 publication, 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. 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.

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。例如，有關我們今年和長期財務業績趨勢和預期、現金流和流動性狀況、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、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的任何聲明。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。

Personalis undertakes no obligation to update these statements, except as required by applicable law. Our press release with our second-quarter 2025 results is available on our website, www.personalis.com, under the Investors section, includes additional details about our financial results. Our website also has the latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website by 5:00 PM Pacific Time today.

除非適用法律要求，否則 Personalis 不承擔更新這些聲明的義務。我們的 2025 年第二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。我們的網站還提供最新的 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 5:00 之前在我們的網站上發布。

With that, I would like to turn the call over to Chris.

說完這些，我想把電話轉給克里斯。

Thank you, Caroline. Good afternoon, everyone, and thank you for joining us. Our second quarter was defined by outstanding execution of our win in MRD strategy. The clinical adoption of NeXT Personal is accelerating dramatically with test volume growing 59% sequentially. We delivered nearly 3,500 clinical results in Q2, and today, our base of ordering physicians has expanded to over 600. Our commercial partnership with Tempus is gaining momentum with reps now commercializing NeXT Personal across four major indications, breast cancer, lung cancer and colorectal cancer as well as immunotherapy monitoring. We believe we're on a path towards securing Medicare coverage for two indications by the end of this year.

謝謝你，卡洛琳。大家下午好，感謝大家的參與。我們第二季的成功之處在於出色地執行了 MRD 策略。NeXT Personal 的臨床應用正在急劇加速，測試量較上季成長 59%。我們在第二季度提供了近 3,500 份臨床結果，如今，我們的訂購醫生基礎已擴大到 600 多名。我們與 Tempus 的商業合作正在蓬勃發展，銷售代表目前已將 NeXT Personal 商業化用於四大適應症，即乳腺癌、肺癌和結直腸癌以及免疫療法監測。我們相信，到今年年底，我們將能夠確保兩種疾病的醫療保險覆蓋。

For those new to our story, Personalis is at the forefront of the minimal residual disease market or MRD market, which is poised to exceed $20 billion annually. We believe we are transforming cancer care. Using a simple blood draw, our NeXT Personal test monitors therapy and detects residual cancer with ultrasensitivity, capable of finding just one fragment of tumor DNA in a million. This allows us to see cancer recurrence months ahead of imaging and positions Personalis to capture a significant share of this transformative market opportunity.

對於剛了解我們故事的人來說，Personalis 處於微小殘留疾病市場或 MRD 市場的前沿，預計將超過 200 億美元的年產值。我們相信我們正在改變癌症治療。透過簡單的抽血，我們的 NeXT Personal 測試可以監測治療情況並以超高靈敏度檢測殘留癌症，能夠在一百萬個腫瘤 DNA 片段中發現一個。這使我們能夠在成像之前數月預見癌症復發，並使 Personalis 能夠抓住這一變革性市場機會的很大份額。

Turning to our results. We delivered $17.2 million in revenue for the second quarter. Our performance reflects two distinct stories. First, our core clinical business is exceeding our internal plans and demonstrating momentum. Second, we're actively managing the near-term industry-wide headwinds in biopharma R&D spending.

談談我們的結果。我們第二季的營收為 1,720 萬美元。我們的表演反映了兩個截然不同的故事。首先，我們的核心臨床業務超越了我們的內部計劃並顯示出強勁的發展勢頭。其次，我們正在積極應對生物製藥研發支出方面近期整個產業的不利因素。

Political changes in the health care sector and the uncertainty of tariffs have impacted our customers' translational research projects, resulting in revenue from a few significant contracts shifting out of Q2 and an overall weakness the rest of the year. In light of these industry dynamics, we're updating our full year revenue guidance to a range of $70 million to $80 million. While this range reflects the current variability in the biopharma project timing, we have a concrete three-point action plan to aggressively pursue the high end of this range and expect to finish the year with maximum momentum.

醫療保健領域的政治變化和關稅的不確定性影響了我們客戶的轉化研究項目，導致一些重要合約的收入從第二季度轉移出去，並導致今年剩餘時間的整體收入疲軟。鑑於這些產業動態，我們將全年營收預期更新為 7,000 萬美元至 8,000 萬美元。雖然這一範圍反映了生物製藥項目時間表的當前變化，但我們有一個具體的三點行動計劃，以積極追求這一範圍的高端，並期望以最大的勢頭結束今年。

Here are the three key drivers that give us conviction. First, we're converting our deep biopharma pipeline, especially for MRD. While project timelines have shifted and affected translational business, demand for our MRD technology is robust with growing adoption of NeXT Personal for MRD by our biopharma customers. NeXT Personal gives our customers a tool with ultrasensitivity to measure therapeutic efficacy, and we remain on plan to grow this segment by 300% to 400% this year with a meaningful revenue contribution expected in the fourth quarter.

以下是讓我們深信不疑的三個關鍵驅動因素。首先，我們正在轉換我們的深度生物製藥管道，特別是針對 MRD。雖然專案時間表已經改變並影響了轉換業務，但隨著我們的生物製藥客戶越來越多地採用 NeXT Personal 進行 MRD，對我們的 MRD 技術的需求仍然強勁。NeXT Personal 為我們的客戶提供了一個超靈敏的工具來測量治療效果，我們仍計劃今年將這一領域增長 300% 至 400%，預計第四季度將帶來可觀的收入貢獻。

Second, we are capitalizing on our clinical momentum. Our clinical business is a growth engine as we continue to project 30% to 40% quarter-over-quarter growth, fueled by exceptional traction with our partner, Tempus and our expanding base of ordering physicians. This is a core pillar of our growth story, and it is accelerating.

其次，我們正在利用我們的臨床勢頭。我們的臨床業務是一個成長引擎，我們預計其季度環比增長率將繼續達到 30% 至 40%，這得益於我們與合作夥伴 Tempus 的出色合作以及不斷擴大的訂購醫生群體。這是我們成長故事的核心支柱，並且正在加速發展。

Third, we are advancing towards a pivotal reimbursement catalyst. Achieving Medicare reimbursement in two indications this year remains a top priority and is on track. This is expected to be a major inflection point for the company, unlocking a significant revenue stream. So let me be direct. We own the Q2 revenue shortfall.

第三，我們正在朝著關鍵的報銷催化劑邁進。今年，實現兩項適應症的醫保報銷仍然是我們的首要任務，並且進展順利。預計這將成為該公司的重要轉捩點，帶來可觀的收入來源。所以讓我直接說吧。我們對第二季的營收缺口負有責任。

Moving forward, we're pushing hard on the levers we can control to finish the year strong instead of passively waiting for market conditions to change.

展望未來，我們將竭盡全力，利用我們能夠控制的槓桿，以強勁的勢頭結束今年的業績，而不是被動地等待市場狀況的變化。

Now let's walk through the pillars of our win in MRD strategy. First is accelerating clinical adoption. Through our partnership with Tempus, we delivered 3,478 tests this quarter, a 59% increase from the first quarter and over 575% growth from last year. This is a direct testament to how our ultrasensitive approach is resonating with clinicians. Our growing base of over 600 physicians confirms that NeXT Personal's ultrasensitive results are a key differentiator, giving them greater confidence in their clinical decisions.

現在讓我們來回顧一下 MRD 策略勝利的支柱。首先是加速臨床應用。透過與 Tempus 的合作，我們本季進行了 3,478 次測試，比第一季度增長了 59%，比去年同期增長了 575% 以上。這直接證明了我們的超敏感方法如何引起臨床醫生的共鳴。我們不斷成長的超過 600 名醫生群體證實，NeXT Personal 的超靈敏結果是一個關鍵的區別因素，讓他們對自己的臨床決策更有信心。

This quarter, we expanded our Tempus partnership to include colorectal cancer, a major market where we believe our test ultrasensitivity can address a significant unmet need. Initial feedback is extremely positive, and we're moving aggressively to capitalize on the opportunity. In light of this, we are also adding to our own personal sales force and expect to exit the year with 12 to 15 field professionals on the ground.

本季度，我們擴大了與 Tempus 的合作關係，將結直腸癌納入其中，這是一個主要市場，我們相信我們的測試超敏感性可以滿足尚未滿足的重大需求。初步回饋非常積極，我們正在積極採取行動，利用這個機會。有鑑於此，我們還將擴大自己的個人銷售隊伍，預計今年底將擁有 12 至 15 名現場專業人員。

Second is driving reimbursement through world-class evidence. The clinical data validating our approach is nothing short of outstanding. At ASCO in June 3 studies underscore the power of our technology. The PREDICT and SCANDARE studies demonstrated that NeXT Personal can predict patient outcomes in neoadjuvant breast cancer with nearly half of all positive detections found in the ultrasensitive range that our assay unlocks. Furthermore, an important study from AstraZeneca showed our test detecting cervical cancer progression up to 16 months ahead of imaging.

第二是透過世界一流的證據推動報銷。驗證我們方法的臨床數據非常出色。6 月在 ASCO 舉行的 3 項研究強調了我們技術的強大功能。PREDICT 和 SCANDARE 研究表明，NeXT Personal 可以預測新輔助乳癌患者的治療結果，幾乎一半的陽性檢測結果都處於我們檢測解鎖的超敏感範圍內。此外，阿斯特捷利康的一項重要研究表明，我們的測試可以比影像學檢查提前 16 個月檢測到子宮頸癌進展。

We believe this is the caliber of evidence that doesn't just support clinical practice, it transforms it. Behind the strength of our clinical evidence, we continue to target achieving coverage for at least two indications this year. We have recently submitted our IO monitoring dossier for Medicare coverage. And so, we now have two indications in process for coverage and the lung cancer dossier is on track. Some aspects of the coverage process are beyond our control, but we continue to be confident that our data meets the bar for coverage.

我們相信，這種證據等級不僅支持臨床實踐，而且可以改變臨床實踐。憑藉我們強大的臨床證據，我們今年將繼續致力於實現至少兩種適應症的覆蓋。我們最近提交了醫療保險覆蓋範圍的 IO 監測檔案。因此，我們現在有兩種適應症正在被覆蓋，而且肺癌檔案也進展順利。覆蓋過程的某些方面是我們無法控制的，但我們仍然相信我們的數據符合覆蓋標準。

Third is leading with biopharma partners. Our technology gives partners a powerful tool to accelerate clinical trials. While total biopharma revenue of $11.1 million reflects the project delays, I mentioned, the underlying growth in our strategic focus area is exceptional. As I stated, NeXT Personal revenue from biopharma is on track for 300% to 400% year-over-year growth and the new customers noted on our last call remain on track to generate over $5 million each in revenue this year. We project total biopharma revenue will rebound to between $11 million and $13 million in the third quarter.

第三是與生物製藥合作夥伴一起引領。我們的技術為合作夥伴提供了加速臨床試驗的強大工具。雖然我提到過，1,110 萬美元的生物製藥總收入反映了專案延遲，但我們戰略重點領域的潛在成長卻是卓越的。正如我所說，NeXT Personal 來自生物製藥的收入有望實現同比增長 300% 至 400%，而我們上次電話會議中提到的新客戶今年仍有望各自創造超過 500 萬美元的收入。我們預計第三季生物製藥總收入將反彈至 1,100 萬美元至 1,300 萬美元之間。

Our expectations are much higher for the fourth quarter, typically the best quarter of the year.

我們對第四季的期望要高得多，因為它通常是一年中最好的季度。

In summary, Personalis is executing with precision on our strategy to win in MRD. Our team and our partners are deploying our ultrasensitive technology that we believe can redefine the standard of care for patients with cancer. I'm proud of the progress that our team has made so far in 2025, and I'm thrilled with the commercial momentum and partnership with Tempus. This is a transformative year for our company and most importantly, for the patients who benefit from our technology. With that, I will now turn it over to Aaron to review our financial results.

總而言之，Personalis 正在精準執行我們的 MRD 致勝策略。我們的團隊和合作夥伴正在部署我們的超靈敏技術，我們相信該技術可以重新定義癌症患者的護理標準。我為我們團隊在 2025 年迄今的進步感到自豪，我對與 Tempus 的商業發展勢頭和合作感到非常興奮。對我們公司來說，這是改變的一年，最重要的是，對於受益於我們技術的患者來說，這是改變的一年。現在，我將把時間交給 Aaron 來審查我們的財務結果。

Thank you, Chris. I will discuss our second quarter 2025 results and then cover guidance for the third quarter and the full year. Total company revenue for the second quarter was $17.2 million, representing a 24% decrease compared with $22.6 million for the same period of the prior year. The decrease in revenue was primarily driven by the expected volume decline of $5.6 million from Natera and $1.3 million from Moderna. We continue to expect the Natera business to conclude by the end of the third quarter.

謝謝你，克里斯。我將討論我們 2025 年第二季的業績，然後介紹第三季和全年的指導。第二季公司總營收為 1,720 萬美元，較去年同期的 2,260 萬美元下降 24%。營收下降主要是由於 Natera 的預計銷量下降 560 萬美元，Moderna 的預計銷量將下降 130 萬美元。我們仍然預計 Natera 業務將在第三季結束時完成。

Biopharma revenue was $11.1 million in the second quarter, representing a 16% decrease compared with $13.2 million for the same period of the prior year. Most of the biopharma revenue decline was from Moderna, as previously mentioned. In addition, Chris discussed the customer project delays that we had in the second quarter. If these projects were not delayed, our biopharma revenue for the second quarter would have increased year-over-year despite the decline from Moderna.

第二季生物製藥收入為 1,110 萬美元，較去年同期的 1,320 萬美元下降 16%。如前所述，生物製藥收入下降的主要原因是 Moderna。此外，克里斯也討論了我們在第二季度遇到的客戶專案延遲問題。如果這些項目沒有被推遲，儘管 Moderna 的收入有所下降，但我們第二季的生物製藥收入仍將同比增長。

For clinical revenue, we recognized $0.5 million of revenue from our NeXT Dx and NeXT Personal molecular tests compared with $0.1 million for the same period of the prior year. Gross margin was 27.6% in the second quarter compared with 35.6% for the same period of the prior year. The year-over-year decrease of 8% was primarily due to the lower revenue and unreimbursed clinical test costs. In the second quarter, we saw an impact of approximately 12% to our gross margin from the unreimbursed clinical test costs. Excluding those expenses, gross margin would have been approximately 40%.

對於臨床收入，我們從 NeXT Dx 和 NeXT Personal 分子測試中獲得了 50 萬美元的收入，而去年同期為 10 萬美元。第二季毛利率為27.6%，去年同期為35.6%。年比下降 8% 主要是由於收入下降和未報銷的臨床測試費用。在第二季度，未報銷的臨床測試費用對我們的毛利率產生了約 12% 的影響。除去這些費用，毛利率約為40%。

We continue to expect total company margins to expand beyond 50% once we have obtained reimbursement coverage for more than a few indications and we achieve scale. Operating expenses were $26.6 million in the second quarter compared with $24.9 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. The second quarter R&D expense was $12.4 million compared with $13 million for the same period of the prior year, and SG&A expense was $14.2 million compared with $11.9 million for the same period of the prior year. Net loss for the second quarter was $20.1 million compared with $12.8 million for the same period of the prior year.

一旦我們獲得多個適應症的報銷範圍並實現規模化，我們仍然預計公司總利潤率將擴大到 50% 以上。第二季營運費用為 2,660 萬美元，而去年同期為 2,490 萬美元。大部分同比增長歸因於與我們的臨床測試量增長相關的銷售費用。第二季研發費用為 1,240 萬美元，去年同期為 1,300 萬美元；銷售、一般及行政費用為 1,420 萬美元，而去年同期為 1,190 萬美元。第二季淨虧損為 2,010 萬美元，而去年同期淨虧損為 1,280 萬美元。

The prior year's net loss included a $3 million noncash gain related to the warrants issued to Tempus and were outstanding as of the second quarter of the prior year. Excluding the noncash gain, the prior year net loss would have been $15.8 million for comparative purposes. Now on to the balance sheet. We finished the second quarter with a strong balance sheet with cash and short-term investments of $173.2 million and no debt other than some small equipment loans.

上一年度的淨虧損包括與發行給 Tempus 的認股權證相關的 300 萬美元非現金收益，截至去年第二季尚未到期。除去非現金收益，去年同期的淨虧損為 1,580 萬美元。現在來看資產負債表。我們在第二季結束時擁有強勁的資產負債表，現金和短期投資為 1.732 億美元，除了一些小額設備貸款外沒有其他債務。

The cash usage from operations and capital equipment additions for the second quarter was $13.2 million. We continue to operate cost effectively. And as mentioned during our last conference call, we expect cash usage for the full year of 2025 of approximately $75 million, an increase of approximately $30 million compared with the amount used in 2024, primarily due to investment in clinical test volumes in advance of reimbursement, expansion of our clinical evidence for NeXT Personal by conducting new studies and additions to our clinical sales team. We expect these investments to help drive NeXT Personal revenue growth post reimbursement later this year and into 2026.

第二季營運和資本設備增加的現金使用量為 1,320 萬美元。我們將繼續以成本效益的方式運作。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約為 7500 萬美元，與 2024 年使用的金額相比增加約 3000 萬美元，這主要是由於在報銷之前對臨床試驗量的投資、通過開展新研究擴大我們對 NeXT Personal 的臨床證據以及擴充我們的臨床試驗量的投資、通過開展新研究擴大我們對 NeXT Personal 的臨床證據以及擴充我們的臨床試驗量的投資、通過開展新研究來擴大我們對 NeXT Personal 的臨床證據以及擴充我們的臨床試驗量的投資、透過開展新研究來擴大我們對 NeXT Personal 的臨床證據以及擴充我們的臨床試驗量的投資、透過開展新研究來擴大我們對 NeXT Personal 的臨床證據以及擴充我們的臨床試驗量的投資、透過開展新研究來擴大我們對 NeXT Personal 的臨床證據以及擴充我們的臨床試驗量的投資、透過開展新研究來擴大我們對 NeXT Personal 的臨床證據以及擴充我們的臨床試驗量的投資、透過開展新研究來擴大我們對 NeXT Personal 的臨床證據銷售團隊。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. For the third quarter of 2025, we expect total company revenue in the range of $12 million to $14 million, revenue from pharma test and services and all other customers in the range of $11 million to $13 million and revenue from population sequencing and enterprise customers of approximately $1 million. And for the full year of 2025, we revised our guidance and now expect total company revenue in the range of $70 million to $80 million, which is reduced from $80 million to $90 million, and this lower range encompasses the timing and variability of biopharma projects and sample receipt and Medicare reimbursement coverage for NeXT Personal.

現在我想談談指導。對於 2025 年第三季度，我們預計公司總收入在 1,200 萬美元至 1,400 萬美元之間，來自製藥測試和服務以及所有其他客戶的收入在 1,100 萬美元至 1,300 萬美元之間，來自人口測序和企業客戶的收入約為 100 萬美元。對於 2025 年全年，我們修改了指導意見，現在預計公司總收入將在 7,000 萬美元至 8,000 萬美元之間，從 8,000 萬美元至 9,000 萬美元下調，這一較低的範圍涵蓋了生物製藥項目的時間和可變性以及 NeXT Personal 的樣本收據和醫療保險報銷範圍。

Revenue from pharma test and services and all other customers in the range of $52 million to $58 million, which is reduced from $62 million to $64 million; population sequencing plus enterprise customers in the range of $15 million to $16 million; revenue from clinical tests reimbursed in the range of $3 million to $6 million, which has narrowed from $3 million to $10 million. Gross margin in the range of 22% to 24%, and 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. Net loss of approximately $85 million, which includes approximately $20 million of unreimbursed test costs, which has increased from $83 million due to lower revenue, and cash usage of approximately $75 million.

製藥檢測與服務及所有其他客戶的收入在5200萬美元至5800萬美元之間，由6200萬美元降至6400萬美元；來自群體測序及企業客戶的收入在1500萬美元至1600萬美元之間；來自報銷的臨床試驗的收入在300萬美元至600萬美元，由300萬美元降至300萬美元。毛利率在22%至24%之間，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%。淨虧損約為 8,500 萬美元，其中包括約 2,000 萬美元的未報銷測試費用（由於收入下降而從 8,300 萬美元增加），以及約 7,500 萬美元的現金使用。

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. Operator?

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。說完這些，我將把電話轉回給接線生，開始問答環節。操作員？

(Operator Instructions) Dan Brennan, TD Cowen.

（操作員說明）Dan Brennan，TD Cowen。

Maybe the first one just on clinical. So, I know you said Medicare is on track. You did lower the top end of the guide from 3% to 10%, 3% to 6%. So maybe can you just walk through a little bit of like what was the rationale for that? Are you hearing anything back from Medicare?

也許是第一個僅針對臨床的。所以，我知道您說醫療保險正在按計劃進行。你確實將指導價的上限從 3% 降低到了 10%，又從 3% 降低到了 6%。那麼，您能否稍微解釋一下這樣做的理由是什麼？您收到 Medicare 的任何回覆了嗎？

And then b, as we think about the back half of the year for clinical, like what's kind of assumed for Q3 and Q4 at this point?

然後 b，當我們考慮下半年的臨床情況時，目前對第三季和第四季的假設是什麼？

So, Dan, in terms of the guide, the prior guide, for our prior guide, we had a pretty wide range of $3 million to $10 million on the clinical side, primarily due to the number of months we saw before we got to reimbursement. Now that we're in the month of August or early August here, we thought it'd be prudent to tighten the range or narrow the range. And that's how we come up with the $3 million to $6 million estimate. And what we've modeled in the prior guide is we had a lot of different models that we ran or scenarios that we ran in terms of when reimbursement could occur, right? And so that's how we came up with a wider range.

因此，丹，就指南而言，就我們之前的指南而言，臨床方面的範圍相當廣泛，為 300 萬美元到 1000 萬美元，這主要是因為我們在獲得報銷之前看到的月份數。現在我們已經進入八月或八月初，我們認為收緊範圍或縮小範圍是明智之舉。這就是我們得出 300 萬至 600 萬美元估值的原因。我們在先前的指南中建模的是，我們運行了很多不同的模型或場景，以確定何時可以報銷，對嗎？這就是我們如何得出更廣泛的範圍的原因。

And net-net, you could assume that we did have reimbursement for one indication in the latter part of Q3 and then the second one in Q4. We're still targeting two cancer types for the full year. But in terms of the guide now, it looks more reasonable that we'll get two cancer types in the fourth quarter.

總體而言，您可以假設我們確實在第三季後半段獲得了適應症的報銷，然後在第四季度獲得了第二項適應症的報銷。我們全年仍將目標鎖定在兩種癌症類型上。但就目前的指南而言，在第四季度獲得兩種癌症類型看起來更合理。

Yes. So, Dan, it's Chris, and we still feel confident about that. We've had good engagement. Palmetto always does a great job evaluating these tests and these technologies, and we've been engaged with them, and we feel like even after all that engagement that our evidence will meet the bar that they've established. We've got the IO submitted, which is new news.

是的。所以，丹，是克里斯，我們對此仍然充滿信心。我們的合作一直很愉快。Palmetto 在評估這些測試和技術方面總是做得很好，我們也一直在與他們合作，我們覺得即使經過所有的合作，我們的證據也會達到他們設定的標準。我們已經提交了 IO，這是新消息。

And we feel like we have a good line of sight to the TRACERx data being published in lung cancer. So, it's our expectations. We're going to have three shots on goal to get two of them done by the end of the year and have enough time to go through a back and forth. So, we feel like we're in a good position. It's always tough to nail down the exact final timelines on this stuff, but we feel like we're in a good position.

我們感覺到我們對肺癌領域發布的 TRACERx 數據有了很好的了解。所以，這是我們的期望。我們將進行三次嘗試，其中兩次將在年底前完成，並有足夠的時間進行反覆討論。因此，我們覺得自己處於有利地位。確定這些事情的確切最終時間表總是很困難，但我們覺得我們處於有利地位。

Okay. And could you speak a little bit to some of the early use cases? You talked about -- I know you gave some numbers out in terms of the number of doctors that are using it. Just speak to like how is that going? I know it's early, you don't have coverage yet, but how is the number of doctors using it? And kind of where do you find doctors using it specifically? Like what types of areas do you think your ultrasensitive test plays a differentiated role?

好的。您能否談談一些早期的用例？您談到了——我知道您給了一些使用它的醫生的數量。就說說情況怎麼樣？我知道現在還為時過早，你們還沒有覆蓋，但是有多少醫生在使用它呢？您在哪裡可以找到專門使用它的醫生？例如，您認為超敏測試在哪些領域發揮差異化作用？

Yes. I mean, we focus our clinical storytelling into breast cancer, lung cancer and therapy and IO therapy monitoring. We've got some great -- I didn't walk through an example on this call of case study, but we've had doctors using it to find recurrence and founded months ahead, sometimes a metastasis, which really reinforces the value of the technology. We've had doctors using it after neoadjuvant to determine what to do next. We've certainly had doctors using it as a part of therapy and sometimes switching therapy and because they haven't been able to get a longitudinal response and then getting the patient on another drug and seeing a response.

是的。我的意思是，我們將臨床故事的重點放在乳癌、肺癌及其治療和IO治療監測。我們有一些很棒的——我沒有在這次案例研究中舉例說明，但我們有醫生利用它來發現復發，並提前幾個月發現，有時甚至是轉移，這確實強化了這項技術的價值。我們讓醫生在新輔助治療後使用它來確定下一步該怎麼做。我們確實有醫生將其作為治療的一部分，有時會更換療法，因為他們無法獲得縱向反應，然後讓患者服用另一種藥物並看到反應。

And so that's been great. The key value here is that almost 40% of our results, of our positive results continue to be in the ultrasensitive range. And when doctors see that and they -- that sells them over time. And our retention has been phenomenally high. It's probably one of the best products I've ever worked on bringing to market in terms of high early retention and that ramp has been great.

這真是太棒了。這裡的關鍵價值是，我們幾乎 40% 的結果，即我們的陽性結果仍然處於超敏感範圍內。當醫生看到這一點時，他們 — — 這會隨著時間的推移而出售它們。我們的保留率非常高。就早期留存率高而言，這可能是我曾經推向市場的最好的產品之一，而且成長勢頭非常好。

What's happened though recently, and I think this last quarter, we added CRC to the call cycle. And so that's been a whole new evolving use case with higher landmark sensitivity, and we expanded the Tempus arrangement, and we're starting to see some CRC usage and really positive feedback.

但最近發生了什麼，我想這是上個季度，我們在呼叫週期中加入了 CRC。因此，這是一個全新的不斷發展的用例，具有更高的地標敏感度，我們擴展了 Tempus 安排，並且我們開始看到一些 CRC 的使用和真正積極的反饋。

So, across all 4 of those indications, we think the ultrasensitivity is shining. And then the last piece is obviously, gives more confidence to the negative, which is always a good thing when you're sitting across from a patient and you're telling them that it's a good day for them. They don't have any minimal residual disease in their blood that they can measure and having confidence in that's powerful. So, we feel like it's firing across all spots of the clinical flow.

因此，綜合考慮這 4 種跡象，我們認為超敏感性表現突出。最後一點顯然是，給負面情緒帶來更多的信心，當你坐在病人對面並告訴他們這對他們來說是美好的一天時，這總是一件好事。他們的血液中沒有任何可以測量的微小殘留疾病，並且對此充滿信心。因此，我們感覺它正在臨床流程的所有環節中發揮作用。

I know there'll be -- that's terrific because I know there'll be a bunch of questions on pharma. Just kind of one more on the balance sheet. So, you have $173 million in cash. I think you burned $13 million. What's -- can you just remind us of the pathway forward?

我知道會有——這太棒了，因為我知道會有很多關於製藥的問題。這只是資產負債表上的一項內容。所以，你有 1.73 億美元現金。我認為你燒掉了 1300 萬美元。什麼－您能提醒我們前進的道路嗎？

Like how long does that cash last? I know Aaron talked about the gross margin expansion you expect, but you also have the deal with Tempus, which just kind of walk us through a little bit of how we might contemplate your kind of cash flow and any kind of cash flow need going forward?

這些現金能維持多久？我知道 Aaron 談到了您預期的毛利率擴張，但您也與 Tempus 達成了交易，這能否向我們介紹一下我們如何考慮您的現金流以及未來的任何現金流需求？

Sure, Dan. So, we ended the quarter with $173 million of cash. We were -- we have a strong balance sheet. We believe we have plenty of cash to get us not only to the other side of reimbursement, but to get us to cash flow breakeven. In terms of having to go raise money, we're not in that position like we were in the past. So, there's no plans contemplated to having to raise money. We still have plenty of cash to be able to invest in studies, invest in growth of volume here in advance of reimbursement and post reimbursement.

當然，丹。因此，本季結束時我們的現金為 1.73 億美元。我們－我們擁有強大的資產負債表。我們相信，我們擁有充足的現金，不僅可以讓我們獲得償付，而且可以讓我們實現現金流收支平衡。就必須籌集資金而言，我們不再像過去那樣處於那種境地。因此，沒有考慮籌集資金的計劃。我們仍然有足夠的現金來投資研究，投資於償還前和償還後的數量增長。

And then once we get to the other side of reimbursement, then we're really ramping our test volume, then we can sit back and look at other investments that may be required to grow even faster and further into the future.

然後，一旦我們獲得報銷，我們就會真正增加測試量，然後我們就可以坐下來看看未來可能需要更快、更遠成長的其他投資。

Mark Massaro, BTIG.

BTIG 的馬克馬薩羅。

This is Vidyun on for Mark. So just one on biopharma. Is it fair to think about the $10 million reduction as a pushout of revenue rather than being canceled outright? So, is it fair to think about that being reflected in 2026? And is it correct that the -- yes, go ahead.

這是 Vidyun 為 Mark 表演的。因此，僅討論生物製藥。將 1000 萬美元的削減視為收入的減少而不是直接取消是否公平？那麼，認為這一點將在 2026 年體現是否公平？這是正確的嗎？是的，請繼續。

Go ahead. And what was the second part of the question?

前進。問題的第二部分是什麼？

Yes. And then just to clarify, was that pushout related to the personalized cancer vaccine deal that you have with Moderna? And if so, just how do you feel like that value prop is resonating more generally?

是的。然後需要澄清的是，此次延遲是否與您與 Moderna 達成的個人化癌症疫苗協議有關？如果是這樣，您覺得這種價值主張如何引起更普遍的共鳴？

Yes. No. Great. So, let's start with the PCV or the INT individualized neoantigen therapy programs with Moderna. That is on pace and has been sort of a bedrock relationship, and we couldn't be happier with how that's progressed. We had expected that revenue to be down this year because they had enrolled a significant number of patients in their melanoma trial last year, which fueled the revenue and this year is lower, but that's what we expected, and we didn't see anything there.

是的。不。偉大的。那麼，讓我們從與 Moderna 合作的 PCV 或 INT 個體化新抗原治療計劃開始。這項工作正在按計劃進行，並已成為一種基石關係，我們對這一進展感到非常高興。我們原本預計今年的收入會下降，因為去年他們招募了大量患者參與黑色素瘤試驗，這增加了收入，而今年的收入較低，但這正是我們預料到的，而且我們並沒有看到任何變化。

What we've seen in the Q2 was that some of the projects got pushed into Q3 and Q4 and some of the Q3 starting to get pushed back, and we started to see some softness. That's been in the translational sector. And I think what's happened is these biopharma companies have done layoffs as they put -- pull a little tighter on their purse strings, we've seen a slowdown, and we've seen a general softness, and we thought it was prudent to take the guide down given what we're seeing and what we're starting to see appear inside the sector. And it's not surprising to us that it kind of happens in this biopharma segment.

我們在第二季度看到的情況是，一些項目被推遲到第三季度和第四季度，而一些第三季度的項目開始被推遲，我們開始看到一些疲軟現象。這屬於翻譯領域。我認為，這些生物製藥公司之所以進行裁員，是因為他們勒緊了錢袋，我們看到了經濟放緩，也看到了整體的疲軟，我們認為，根據我們所看到的情況以及我們開始看到的該行業內部出現的情況，下調預期是明智之舉。對於這種發生在生物製藥領域的事情，我們並不感到驚訝。

But we're still on fire with the MRD product. I mean, I noted in the prepared remarks that we're still seeing 300% to 400% growth. We've talked about that, and we're right at that spot. We don't see any of the MRD projects slipping out of the year.

但我們仍然對 MRD 產品充滿熱情。我的意思是，我在準備好的發言中指出，我們仍然看到 300% 到 400% 的成長。我們已經討論過這個問題，並且我們正處於這個問題上。我們沒有看到任何 MRD 項目在今年落空。

Secondly, we still have the two bigger customers that we've landed this year north of $5 million in revenue, and they're tracking to do that. And so, the MRD product continues to be exactly where we are, and that's been a real shining light in what we're doing. We haven't -- some of the projects that we expect to go into next year, we don't -- we haven't seen any losses. There's always maybe a clinical trial that doesn't work out that we're doing some tumor profiling work that might get -- the plug might get pulled on that. But we haven't seen any significant losses and certainly not in any meaningful way.

其次，我們今年仍然擁有兩個較大的客戶，他們的收入超過 500 萬美元，他們正在努力實現這一目標。因此，MRD 產品繼續保持我們的現狀，這對我們的工作來說是一盞真正的明燈。我們預計明年將開展的一些項目沒有出現任何損失。我們正在進行的一些腫瘤分析工作可能總是會有臨床試驗失敗，而這些試驗可能會被叫停。但我們並未看到任何重大損失，當然也沒有任何重大損失。

So, it's always -- it's been pushouts and sort of a slowness that I think we're seeing. And I think some of the other companies operating in the space have seen too, and that's where we are. But the core assets here with the MRD is performing phenomenally well with that customer and certainly the clinical customer where we see the nearly 60% quarter-over-quarter growth.

所以，我認為我們看到的總是推遲和某種緩慢的現象。我認為在該領域運營的其他一些公司也看到了這一點，而我們現在的處境也是如此。但 MRD 的核心資產在該客戶以及臨床客戶中表現非常出色，我們看到其環比成長近 60%。

Okay. Perfect. That was great color. And then just a follow-up on the MRD front. Just on the 3,500 NeXT Personal tests, could you guys just discuss if you're seeing maybe an increased number of test time points per patient?

好的。完美的。顏色真棒。然後只是對 MRD 方面的後續跟進。僅在 3,500 次 NeXT Personal 測試中，你們能否討論是否看到每位患者的測試時間點數量增加？

Or is it more so a lift in new physician adds? And then just any attachment to call out of NeXT Personal to your NeXT Dx CGP test as well?

還是這更多的是增加新醫生的數量？然後只需任何附件即可從 NeXT Personal 呼叫到您的 NeXT Dx CGP 測試？

Yes. So, we are seeing growth both in the number of physicians, and I think we talked about we've crossed over 600 now ordering, which is just phenomenal given where we are. And we are seeing us go -- we're going deeper into those accounts, meaning we're getting more samples per physician, and then we're starting to pull through the subsequent. And that's all been on the bedrock of what's been a phenomenal relationship with Tempus.

是的。因此，我們看到醫生的數量正在增長，我想我們說過，現在醫生的數量已經超過 600 人，考慮到我們現在的狀況，這是非常驚人的。我們看到我們正在深入研究這些帳戶，這意味著我們將從每位醫生那裡獲得更多的樣本，然後我們開始進行後續研究。這一切都是我們與 Tempus 之間非凡關係的基礎。

I mean, we work so well with them, and we couldn't be more happy with how that relationship has unfolded. And you're starting to see the success of that really deeply starting to power the numbers and the performance. And so, it's happening across all the metrics.

我的意思是，我們與他們合作得很好，我們對這種關係的發展感到非常高興。並且您開始看到它的成功真正深刻地開始推動數字和性能的發展。所以，它發生在所有指標上。

On NeXT Dx, the CGP test, I think we had our highest quarterly revenue this quarter. That's been the CGP NeXT Dx. It's appended on to many of the tests that we do without Tempus. Tempus sells their CGP when it comes through their channel, but when we have our reps, we get the -- we often get the CGP associated with it, and it's been a nice revenue driver on extra revenue driver on those samples. But the core MRD metrics, it's increasing test per doctor, increasing number of doctors, phenomenal retention and then starting to pull through the subsequent.

在 CGP 測試 NeXT Dx 上，我認為我們本季的季度收入最高。這就是 CGP NeXT Dx。它附加到我們在沒有 Tempus 的情況下進行的許多測試中。Tempus 透過其管道銷售 CGP，但當我們有代表時，我們會得到 - 我們經常會得到與之相關的 CGP，而且它對這些樣品來說是額外的收入驅動力。但核心的 MRD 指標是增加每位醫生的測試數量、增加醫生數量、實現驚人的保留率，然後開始實現後續目標。

Is that helpful? I think I covered everything.

這樣有幫助嗎？我想我涵蓋了所有內容。

Thomas Flaten, Lake Street Capital.

托馬斯‧弗拉頓（Thomas Flaten），湖街資本公司。

Since now that you've run a few thousand samples through the system, I'm curious what you guys have seen in terms of turnaround time for the test, from tissue and blood receipt from the patient's first visit and then to turn around to results. Have you seen any improvement in that? Has it been helpful to have this early access program to work out kinks, et cetera?

由於現在您已經透過系統運行了數千個樣本，我很好奇你們在測試的周轉時間方面看到了什麼，從患者第一次就診時收到組織和血液到得出結果。您覺得這方面有什麼進步嗎？這個早期訪問計劃對於解決問題等有幫助嗎？

Absolutely. What we've done is we've had a good chunk of our R&D staff really focused this last 18 months on how do we start to scale this. And our lead times now have fallen dramatically. We think we're at a spot where we're providing whatever they can get in the marketplace from any other vendor, both on the subsequent and the baseline, and we feel like we're in a really good position. We've invested a lot of money and time and effort in scaling this and starting to do it at scale and haven't missed a beat along the way.

絕對地。我們所做的是，我們讓很大一部分研發人員在過去 18 個月裡真正專注於如何開始擴大這一規模。現在我們的交貨時間已大幅縮短。我們認為，我們能夠提供市場上任何其他供應商能夠提供的任何產品，包括後續產品和基線產品，我們覺得我們處於非常有利的地位。我們投入了大量的金錢、時間和精力來擴大這一規模並開始大規模實施，並且在過程中沒有出現任何問題。

So that's been -- I mean, it's sort of hard to quantify that. But I will just note that the market -- physicians really expect a high level of customer service and the growth that we are seeing quarter over quarter-over-quarter is a tribute to our ability to execute on the operational front because if we were messing this up and we were going weeks and weeks and weeks and days and days and days and losing samples along the way, we would not see the retention, and we would not see the quarterly growth because you can't solve that problem by growing out of it. So, we've been rock solid there and have improved as we've gone, and you see that in the numbers.

所以這是——我的意思是，這有點難以量化。但我要指出的是，市場——醫生確實期望高水平的客戶服務，而我們看到的季度環比增長是對我們運營執行能力的肯定，因為如果我們把事情搞砸了，我們就會連續數週、數週、數天、數天地丟失樣本，那麼我們就無法保留樣本，也不會看到季度增長，因為你不能通過擴大規模來解決這個問題。所以，我們在那裡表現得非常穩固，並且在前進的過程中不斷進步，您可以從數字中看到這一點。

Got it. Helpful. And I'm not sure how many ends you have to use to answer this question, but have you detected what kind of cadence physicians are using with repeat testing with patients that might have been kind of early on in the early access program?

知道了。很有幫助。我不知道您需要用多少個端點來回答這個問題，但是您是否發現醫生在對早期訪問計劃中可能處於早期階段的患者進行重複測試時使用了什麼樣的節奏？

I mean, I think we're seeing -- I think it's a little early to answer that definitively. I mean, we see that the recurrence monitoring is less than the therapy monitoring. The IO therapy, we see more than the recurrence monitoring. That's what we see. But I think it's been -- I think it's what we expected.

我的意思是，我認為我們正在看到——我認為現在明確回答這個問題還為時過早。我的意思是，我們發現復發監測少於治療監測。對於IO治療，我們看到的不只是復發監測。這就是我們所看到的。但我認為這是——我認為這是我們所期望的。

But I think it's a little early into the different use cases and where they are in the clinical flow. And I think we'll have a lot more as the numbers start to get bigger to delve into there.

但我認為現在討論不同的用例以及它們在臨床流程中的位置還為時過早。我認為，隨著數字變得越來越大，我們將有更多可供深入研究的內容。

And then one quick final one. As you guys look to expand your sales team here in the second half of the year, remind us again how you and Tempus are going to kind of co-manage customers? Is there exclusivity depending on who the rep is? Can you just explain a little bit more how that works?

然後是最後一個。當你們希望在今年下半年擴大銷售團隊時，請再次提醒我們，你們和 Tempus 將如何共同管理客戶？是否存在取決於代表是誰的排他性？您能否稍微解釋一下它的工作原理？

Yes. So, I mean, the relationship -- I mean, we're depending on Tempus, and they've powered us, and that's awesome. It really depends on what the doctor and how they want it. And usually, it's honestly probably best for the physicians to drive through the Tempus infrastructure. They're set up in EMRs, and that's really important to clinicians.

是的。所以，我的意思是，這種關係——我的意思是，我們依賴 Tempus，他們為我們提供動力，這太棒了。這實際上取決於醫生的想法和他們想要什麼。通常情況下，醫生最好透過 Tempus 基礎設施來駕駛。它們設置在 EMR 中，這對臨床醫生來說非常重要。

The logistics are often worked out within those institutions by Tempus. And so that allows us to move quicker in a really seamless way and in a way that meets customer needs. And it was one of the driving forces internally here at Personalis to do the Tempus arrangement. And so, I think by and large, physicians would -- because that infrastructure is in place, be happy to roll it through Tempus and we're -- we do whatever is best for the doctor and for their patients. And so that's where it sorts out.

後勤工作通常由 Tempus 在這些機構內制定。這樣，我們就能以真正無縫的方式更快地行動，並滿足客戶的需求。這也是 Personalis 內部進行 Tempus 安排的驅動力之一。因此，我認為，總體而言，由於基礎設施已經到位，醫生們很樂意透過 Tempus 來推廣它，而我們則會盡一切努力為醫生和他們的患者提供最好的服務。這就是事情解決的地方。

As we scale the group, we've always said we'll be scaling it. And that group does a couple of things. It supports the relationship where needed and particularly in big academic medical centers with KOLs. I mean, one of the things that I think have made Personalis unique is that we've worked with many of the top people in the world, and we have access to some of the leading sample biobanks to build data and that sort of really starts to drive clinical usage.

當我們擴大集團規模時，我們總是說我們會擴大規模。這個小組做了一些事情。它支持在需要的地方建立關係，特別是與 KOL 建立關係的大型學術醫療中心。我的意思是，我認為 Personalis 的獨特之處之一是我們與世界上許多頂尖人物合作，我們可以存取一些領先的樣本生物庫來建立數據，而這確實開始推動臨床使用。

And so, we've put a focus of our sales infrastructure working with those people and those relationships. And so, we're investing and continue to invest there. And then secondarily, as strong as Tempus is, they are not the only cancer company. And so, doctors have other implementations set up. And so, our reps will try to make sure that we close any market gaps and provide coverage to every physician in the community even if they're not doing business with Tempus. But if it's a Tempus account, it probably will go through the Tempus architecture.

因此，我們將銷售基礎設施的重點放在與這些人和這些關係的合作上。因此，我們正在那裡投資並繼續投資。其次，儘管 Tempus 實力雄厚，但他們並不是唯一一家抗癌公司。因此，醫生們已經制定了其他實施方案。因此，我們的代表將盡力確保彌補任何市場空白，並為社區中的每位醫生提供保險，即使他們沒有與 Tempus 做生意。但如果是 Tempus 帳戶，它可能會經過 Tempus 架構。

But yes, we've been really happy with how it's worked, Thomas.

但是的，我們對它的運作方式感到非常滿意，托馬斯。

Yuko Oku, Morgan Stanley.

奧裕子，摩根士丹利。

This is Edmund on for Yuko. Can you guys hear me?

這是 Edmund 為 Yuko 表演的。你們聽得到我說話嗎？

Yes.

是的。

I just wanted to start off in the biopharma end market. I was wondering if you guys provide an update to what you estimate the impact of all these policy headwinds are going to be on your biopharma customers. I think you previously pointed to $3 million to $5 million of impact with your pipeline offsetting that. I was wondering if you have an updated estimate.

我只是想從生物製藥終端市場開始。我想知道你們是否能提供最新消息，說明你們估計所有這些政策不利因素將對你們的生物製藥客戶產生的影響。我認為您之前指出過，您的管道將產生 300 萬到 500 萬美元的影響，可以抵消這一影響。我想知道您是否有更新的估價。

Ed, this is Aaron. So, in terms of your question about the biopharma landscape and what's going on in the government front. So, in our prepared remarks, we did talk about revising our guidance from biopharma down from $62 million to $64 million down to $52 to $58. In terms of what we're seeing is on the translational research side of the business, where ImmunoID NeXT is our offering. We are seeing delays of projects, and we've seen that occurring from Q2 and Q3.

艾德，這是亞倫。因此，關於您關於生物製藥領域以及政府方面正在發生的事情的問題。因此，在我們準備好的發言中，我們確實談到了將生物製藥的指導金額從 6,200 萬美元下調至 6,400 萬美元，下調至 5,200 萬美元至 5,800 萬美元。就我們所看到的業務的轉化研究方面而言，ImmunoID NeXT 是我們的產品。我們看到專案正在延遲，我們已經看到這種情況在第二季和第三季發生。

So, projects in Q2 and Q3 have shifted to the right. It's our assumption that these projects are not lost. They're just delayed a little bit. So, it's going to take two to four quarters before those get completed and convert to revenue. What's really strong for us right now is the MRD offering, NeXT Personal with biopharma.

因此，Q2 和 Q3 的項目已經向右移動。我們假設這些項目沒有遺失。他們只是稍微耽擱了一點。因此，這些工作需要兩到四個季度才能完成並轉化為收入。目前對我們來說真正強大的是 MRD 產品，即具有生物製藥功能的 NeXT Personal。

Our funnel continues to grow and expand. And as Chris said in the prepared remarks, we have two customers that are $5 million each, and we believe we're going to fulfill those this year.

我們的通路不斷成長和擴大。正如克里斯在準備好的演講中所說，我們有兩個客戶，每個客戶的金額為 500 萬美元，我們相信今年我們將滿足這些客戶的要求。

Got you. And then on the competitive landscape, following the recent announcement of the coverage determination for Saga's Pathway, could you elaborate on how NeXT Personal is differentiated? And how are you thinking about balancing your MRD investments between near-term margin pressures versus immediate top line benefits upon receiving reimbursement?

明白了。然後就競爭格局而言，在最近宣布了 Saga Pathway 的覆蓋範圍確定之後，您能否詳細說明 NeXT Personal 有何不同？您如何考慮在短期利潤壓力與收到報銷後的直接營業收益之間平衡您的 MRD 投資？

I didn't catch the last part of that. Sorry.

我沒聽清楚最後一部分。對不起。

Just how are you balancing -- thinking about balancing your MRD investments between suffering from near-term margin pressures versus seeing more of a top line impact upon reimbursement?

您究竟是如何平衡的——考慮平衡您的 MRD 投資，是承受短期利潤壓力，還是看到報銷對營收有更大的影響？

Got it. Yes. No, we -- I mean, first of all, as Saga got reimbursement in breast cancer. And I think that's great. I think that's great to that another player has gotten it.

知道了。是的。不，我們——我的意思是，首先，Saga 獲得了乳癌補償。我認為這很棒。我認為另一位球員獲得這個獎項真是太好了。

They were published several months ahead of us. And so, our assumption has been always that they had submitted well ahead of us. So, they proceeded on probably a similar time frame. And their data was good. And we feel like we clear the bar and we feel like we're in a good position.

它們比我們早幾個月出版。因此，我們一直認為他們比我們更早提交了。因此，他們可能按照相似的時間框架進行。他們的數據很好。我們感覺我們已經達到了標準，並且感覺我們處於一個很好的位置。

And I -- when we saw that they had gotten coverage and reimbursement, it just gave us confidence that the data that we have is on the right track. We continue to invest deeply in evidence development, increasingly working with some prospective clinical trials of biopharma or within the breast cancer space with some of the top thought leaders, and we'll be announcing things along the way. We've had the prospective Be Stronger trial in triple-negative breast cancer, where we've been enrolling patients in a prospective way, but we're working with a lot of other top medical institutions.

當我們看到他們獲得了保險和報銷時，我們就相信我們掌握的數據是正確的。我們將繼續在證據開發方面進行深入投資，越來越多地與一些頂尖思想領袖合作進行生物製藥領域的一些前瞻性臨床試驗或乳癌研究，並且我們將在此過程中宣布一些消息。我們已經針對三陰性乳癌進行了前瞻性的「Be Stronger」試驗，我們一直在以前瞻性的方式招募患者，但我們正在與許多其他頂級醫療機構合作。

We didn't really focus on it in this call, but the ASCO data was particularly powerful with PREDICT and with SCANDARE and gives us an opportunity to expand ultimately the coverage there into the neoadjuvant setting. So those data sets were particularly great. And the PREDICT trial was a multicenter trial and the data was again another oral presentation at ASCO. And so, we continue to invest aggressively there, and we think that that's the right spot to be -- to be investing. I would remind you that the economics of the Tempus arrangement means that we can really get a lot of sales and marketing leverage without having to invest a ton because we're leveraging their channel and then paying them for market value for the services as we go along.

我們在這次電話會議中並沒有真正關注它，但 ASCO 數據對於 PREDICT 和 SCANDARE 來說特別強大，並使我們有機會最終將其覆蓋範圍擴展到新輔助治療領域。所以這些數據集特別棒。PREDICT 試驗是一項多中心試驗，其數據在 ASCO 上再次進行了口頭聲明。因此，我們繼續在那裡積極投資，我們認為那裡是投資的正確地點。我想提醒你，Tempus 協議的經濟效益意味著我們可以真正獲得大量的銷售和行銷槓桿，而不必投入大量資金，因為我們利用他們的管道，然後在我們進行的過程中按照服務的市場價值向他們支付費用。

So, it allows us to scale without as much short-term investment in the sales and marketing infrastructure to get to the same spot.

因此，它使我們能夠擴大規模，而無需在銷售和行銷基礎設施上進行太多的短期投資即可達到相同的水平。

I think the other question that Edmund, you had was balancing the volume with margins. So, what we can say there is, Chris said in his prepared remarks that our growth targets are 30% to 40%. We've been growing at a rate of 50% plus sequentially every quarter, right? So, if you look at the run rate from Q2 or 3,500 tests or so. That's basically a $6 million revenue run rate, assuming full reimbursement and assuming an average price of, let's say, $7,000 over four tests, including the first time point, which is more expensive, so $1,750 per test or so.

我認為 Edmund 您的另一個問題是如何平衡銷售和利潤。因此，我們可以說的是，克里斯在他的準備好的發言中說，我們的成長目標是 30% 到 40%。我們每季都以 50% 以上的速度成長，對嗎？因此，如果您查看第二季的運行率或 3,500 次測試左右。這基本上是 600 萬美元的收入運行率，假設全額報銷，並假設四次測試的平均價格為 7,000 美元，包括第一次測試，這更昂貴，所以每次測試大約為 1,750 美元。

We don't -- we're not saying exactly what our reimbursed price is going to be, but we're just providing an estimate based upon what the incumbent has today, right? So, if you look at that, that's a $24 million annual revenue run rate in the second quarter. We're going to continue to grow at a rate of 30% to 40% as we go forward at a minimum.

我們不會——我們不會確切地說出我們的報銷價格是多少，但我們只是根據現任者目前的狀況提供一個估計，對嗎？因此，如果你看一下，你會發現第二季的年收入運作率為 2,400 萬美元。我們將繼續以至少 30% 至 40% 的速度成長。

We are balancing the cash burn with this growth trajectory. We're trying to be prudent on the cash side. But we're seeing phenomenal take-up from a volume standpoint, and we want to continue to go as fast as we can, primarily because once reimbursement coverage does come in the fourth quarter, it's going to flip to revenue. And we want as high a revenue run rate as we can because we believe that, that's going to give the greatest value back to our shareholders, okay? And so that's kind of the way we're thinking about it.

我們正在平衡現金消耗和成長軌跡。我們在現金方面盡量保持謹慎。但從數量的角度來看，我們看到了驚人的成長，我們希望繼續盡可能快速地發展，主要是因為一旦第四季報銷範圍確實擴大，它就會轉化為收入。我們希望收入運行率盡可能高，因為我們相信，這將為我們的股東帶來最大的價值，好嗎？這就是我們思考這個問題的方式。

Our margin guide of 22% to 24% does contemplate these unreimbursed test costs in advance of reimbursement.

我們的 22% 至 24% 的利潤率指導確實在報銷之前考慮了這些未報銷的測試費用。

Subbu Nambi, Guggenheim.

蘇布南比 (Subbu Nambi)，古根漢美術館。

Can you talk through some of your conversations at ASCO? You touched on this a little in the previous question Q&A. How did that reinforce the approach you guys are taking right now? And what are some of the things you learned to implement in the second half of this year and beyond?

您能談談您在 ASCO 的一些談話嗎？您在上一個問題的問答中稍微提到了這一點。這如何強化了你們現在採取的方法？您學到了哪些東西，可以在今年下半年及以後付諸實行？

Yes. Thanks for the question. This is Rich. Yes. So, we had a really great ASCO, as Chris alluded to. And notably, at ASCO, we introduced our first neoadjuvant breast cancer data in triple-negative breast cancer with two studies, PREDICT and SCANDARE. And what was really terrific about that was that they showed very similar findings that our test was highly, highly predictive of relapse for patients that have gotten neoadjuvant.

是的。謝謝你的提問。這是里奇。是的。正如克里斯提到的那樣，我們舉辦了一場非常棒的 ASCO。值得注意的是，在 ASCO 上，我們透過兩項研究 PREDICT 和 SCANDARE 推出了首批三陰性乳癌新輔助治療數據。真正令人驚訝的是，他們得出了非常相似的結論，即我們的測試對於接受新輔助治療的患者的復發具有高度的預測性。

And so, patients that were positive on our test were highly likely to relapse versus those who were negative. And it actually compared very favorably with the industry standard approach called PAT CR. And so that was really an important step because that's sort of the way people have done it before.

因此，與檢測結果為陰性的患者相比，檢測結果呈陽性的患者復發的可能性更高。事實上，它與稱為 PAT CR 的行業標準方法相比非常有利。這確實是重要的一步，因為人們以前就是這麼做的。

And what they showed was our test was highly predictive independent of PAT CR. So, what that kind of sets us up to do is really expand our MolDx coverage approach to -- you can expect that we'll be submitting for reimbursement for neoadjuvant breast cancer once these studies get published much in the same way we've been pursuing the other indications.

他們表明我們的測試具有高度的預測性，不受 PAT CR 的影響。因此，這讓我們真正擴大了 MolDx 的覆蓋範圍——你可以預期，一旦這些研究發表，我們就會提交新輔助乳癌的報銷申請，就像我們一直在尋求其他適應症的方法一樣。

So, the way to think about it is this year, we go the breast lung and IO, we're working on that. Next year, we'll be bringing CRC along and expanding breast cancer as those papers get published.

因此，今年我們要考慮的是，我們將進行乳房、肺臟和腹腔鏡手術，我們正在努力實現這一點。明年，隨著這些論文的發表，我們將帶來 CRC 並擴大乳癌研究。

Got it, Chris. And Chris, I know it's still early and you guys are still waiting for Medicare reimbursement, but any conversation with pricing at all or all that will only happen once you have the coverage?

明白了，克里斯。克里斯，我知道現在還為時過早，你們還在等待醫療保險報銷，但是有沒有關於定價的討論，或者只有在獲得保險後才會進行這些討論？

Yes, it does only happen after we get the coverage. But we've told people to put in their models similar to what's being reimbursed now for the 16-variant exome-based testing approach because we think that, that's sort of the floor, and we think that the Medicare reimburses ultimately based on the resources applied and the whole genome approach is a more cost-intensive approach along with 1,800 variants. And so we think there are shots on goal that go higher, but we've encouraged people to build the models where that's upside. And when we talk about our gross margins being 60% and the Tempus sales and marketing percentages being in the 20%, 25% range, et cetera, and the ability to have transformational economics around those kinds of numbers, we do that assuming the current reimbursement in the marketplace.

是的，只有在我們獲得保險後才會發生這種情況。但是我們告訴人們，在他們的模型中要加入類似於現在基於 16 個變體外顯子組的測試方法的報銷方法，因為我們認為，這是一種底線，我們認為醫療保險最終會根據所應用的資源進行報銷，而全基因組方法是一種成本更高的方法，並且有 1,800 個變體。因此，我們認為還有更高的目標，但我們鼓勵人們建立具有上行潛力的模型。當我們談到我們的毛利率為 60%、Tempus 的銷售和行銷百分比在 20%、25% 左右等等，以及圍繞這些數字實現轉型經濟的能力時，我們是在假設市場上目前的報銷情況的情況下這樣做的。

Got it. And then more of a high-level question. But the longer reimbursement takes, have you seen any erosion in interest from docs who currently cannot serve due to gating volumes, and they choose other competitors who are available? Or is it too early for any of these things to be a factor?

知道了。這是一個更高層次的問題。但是，隨著報銷時間的延長，您是否看到醫生的興趣有所下降，因為目前由於門診量限製而無法提供服務，他們轉而選擇其他可用的競爭對手？或者說，這些因素現在成為影響因素還為時過早？

No, we haven't seen any of that. And we've been expanding out the number of doctors and been able to continue to expand. And I think at this point, it's a rate of how fast we push the gas rather than just gating people. We still have some physicians on the wait list, but we've been growing out pretty significantly and making sure we take care of people that really, really want access. But we spent a lot of our time, both with ourselves and our partner going deeper into accounts and really reinforcing the power of the ultrasensitive range because that's what's cementing the relationships, and that's what's starting to power the long-term success as you go deeper into accounts because they see the value of our approach.

不，我們沒有看到任何這樣的事。我們的醫生數量一直在增加，並且能夠繼續增加。我認為，在這一點上，這取決於我們推動油門的速度，而不僅僅是限制人們的速度。我們仍有一些醫生在等候名單上，但我們已經取得了相當大的發展，並確保我們能夠照顧到真正需要治療的人。但是，我們花了很多時間，包括我們自己和我們的合作夥伴，深入了解客戶，真正加強超敏感範圍的力量，因為這是鞏固關係的關鍵，也是隨著您深入了解客戶而開始推動長期成功的因素，因為他們看到了我們方法的價值。

Mike Matson, Needham & Company.

麥克‧馬森 (Mike Matson)，Needham & Company。

Yes. So just had a question kind of on the Tempus arrangement. So, let's say that in the third quarter, you were to get the reimbursement for, say, lung cancer. My understanding is that they've just been kind of selling this or I guess, pitching it to doctors to use with any kind of cancer essentially. So, is there a way that you can sort of incentivize them or Tempus can incentivize those reps to focus more on the cancer types where you will initially have coverage?

是的。所以我只是想問一下關於 Tempus 安排的問題。因此，假設在第三季度，您將獲得肺癌等疾病的報銷。我的理解是，他們只是在銷售這種藥物，或者我猜，是向醫生推銷這種藥物，用於治療任何類型的癌症。那麼，有什麼方法可以激勵他們，或者 Tempus 可以激勵這些銷售代表更多地關注您最初會涵蓋的癌症類型？

Or in other words, to try to ramp the revenue more quickly and reduce the cash burn, I guess, while you're working on the other cancer indication coverage?

或者換句話說，我想，在您致力於其他癌症適應症覆蓋的同時，嘗試更快地增加收入並減少現金消耗？

Yes. That's a great way to -- great question. So they focus in on the lung cancer, the breast cancer and immunotherapy monitoring and increasingly CRC. Almost all of our samples hit within those indications, both that we're getting ourselves and that they're getting. So, they're all sort of tied -- most of them are tied to those core indications.

是的。這是一個很好的方法——很好的問題。因此，他們專注於肺癌、乳癌和免疫療法監測以及 CRC。幾乎我們所有的樣品都符合這些指標，無論是我們自己得到的還是他們得到的。所以，它們都是有連結的——其中大多數都與那些核心指示有關。

And we don't receive a lot of samples all over the map, to be quite honest. They kind of fit the core thing. I do think there's an opportunity, let's say, we got lung cancer or breast cancer first. I do think there's an opportunity to preferentially focus in on physicians that just treat those types of things. But it's hard to go to physicians and tell them only send us these types of patients per se because physicians want to be able to offer the technology in a universal way or a sort of consistent way based on what they think is best for their patients.

老實說，我們在各地收到的樣本並不多。它們有點符合核心內容。我確實認為有機會，比如說，我們先得了肺癌或乳癌。我確實認為有機會優先關注那些只治療這類疾病的醫生。但很難告訴醫生只給我們發送這些類型的患者，因為醫生希望能夠以通用的方式或基於他們認為對患者最有利的方式以一致的方式提供該技術。

So, I don't think we have complete control to pull those levers, but we do have some control to sort of push in the direction of wherever coverage is if there are physicians that have certain spikes. The way we're looking at it.

因此，我認為我們沒有完全的控制權來拉動這些槓桿，但如果有醫生出現某些峰值，我們確實可以控制以某種方式推動覆蓋範圍的方向。我們看待它的方式。

All right. I understand. And then just you announced the -- you're going to pursue the colorectal cancer, I guess, reimbursement eventually. So where do things stand with the data in the press release cited the Victory data, but I mean, is that sufficient? And then what are the milestones, I guess, does it need to be -- I assume it need to be published or something?

好的。我明白。然後您就宣布——我想，您最終將尋求大腸癌的報銷。那麼新聞稿中所引用的勝利數據狀況如何？我的意思是，這足夠嗎？那麼我猜里程碑是什麼，它需要——我假設它需要被發布或其他什麼？

And do you need any other studies or data there?

您還需要其他研究或數據嗎？

No, absolutely. So that data was phenomenal. We've got great feedback from it, but it's preliminary. It's a prospective study, which is different than some of the studies that we worked on, which are retrospectively analyzed, prospectively gathered samples a little bit different because you get it all when you do it. This one, it's going forward.

不，絕對不是。所以這些數據是驚人的。我們收到了很好的回饋，但這只是初步的。這是一項前瞻性研究，與我們進行過的一些回顧性分析研究不同，前瞻性地收集樣本略有不同，因為當你這樣做時，你會得到所有資訊。這一個，它正在向前發展。

And the investigator hasn't decided that with the study yet, at some point, we will do that and then the team will -- investigator will publish it, and then we'll submit that for reimbursement. And that's still TBD in terms of timing.

研究人員尚未決定是否進行研究，在某個時候，我們會這樣做，然後團隊將 - 研究人員將發布它，然後我們將提交它以獲得報銷。就時間而言，這仍有待確定。

(Operator Instructions) Swayampakula, H.C. Wainwright.

（操作員指示）Swayampakula，H.C. Wainwright。

This is RK from H.C. Wainwright. I got on the call a little bit late, so I apologize if you kind of addressed some of these issues in your opening remarks. Just looking at the pharma test and services revenue and seeing how they did not perform to the level that you were expecting going into the second quarter. And also thinking about the full year after completing one-half, it looks like you're not going to -- at least in your current language, you're not really thinking about much of a growth from here onwards for the second half compared to first half.

這是來自 H.C. Wainwright 的 RK。我接電話有點晚了，所以如果您在開場白中提到了其中一些問題，我深表歉意。只要看一下製藥測試和服務收入，就會發現它們在第二季的表現並未達到您預期的水平。並且考慮到完成上半年後的全年情況，看起來你不會——至少用你現在的語言來說，你並沒有真正考慮從現在開始下半年與上半年相比會有多大的增長。

What has changed in the pharma business side of things that's not progressing as well as you thought you would? Is this the clinical programs? Or is this more than that? If you can just give us a little bit of color. And is this just for this year?

製藥業務方面發生了哪些變化，進展不如您想像的那麼好？這是臨床項目嗎？或者這還不只這些？如果您能給我們一點顏色的話。這只是今年的情況嗎？

And once hopefully, the market turns around and the funding is better for everybody, should we see that growth?

一旦市場好轉，融資條件對每個人都更好，我們應該看到這種成長嗎？

No, I think that's great. I think we're seeing -- so a couple of snapshots here to think about. We're seeing phenomenal growth on the MRD side inside biopharma customers, and that's all on track. And every time we've talked about it, every one of the internal numbers, the 300% to 400% annual growth, the couple of new customers that are generating north of $5 million, that's all on plan, and we feel like we're performing really well. That's really where we're investing.

不，我認為這很棒。我想我們看到了——這裡有幾個快照可供思考。我們看到生物製藥客戶內部的 MRD 方面出現了驚人的成長，而且一切都在按計劃進行。每次我們談論它時，每一個內部數字，300％到400％的年增長率，幾個新客戶的收入超過500萬美元，這一切都在計劃之中，我們覺得我們的表現非常好。這確實是我們投資的地方。

The other part of the business, which is the translational research phase, we'll receive a large sample of -- a large group of samples, and we will run it through our tumor profiling engine and the biopharma company will use that data to potentially find new biomarkers to fuel their drug development. That's like more futuristic type of research. That one, we felt the slowness. And we expect it to pick up as things settle down.

業務的另一部分是轉化研究階段，我們將收到大量樣本，我們將透過腫瘤分析引擎運行它，生物製藥公司將使用這些數據來尋找新的生物標記以推動他們的藥物開發。這就像是更具未來感的研究。那一次，我們感受到了緩慢。我們預計，隨著情況逐漸穩定，這一數字將會回升。

That's probably driven by a lot of the questions around how drug development processes go, drug pricing in the current system and certainly tariffs. And you're seeing layoffs within some of these companies and just a general slowness relative to some of the earlier stage R&D, and that's what we're feeling. We think that, that's temporary, and we think it will sort itself out. But I would say that we're still expecting that product to be flattish to a little bit of growth this year. I mean, we're still -- it's not that the product is in a tail spin at all.

這可能是由許多關於藥物開發過程、現行體系中的藥品定價以及關稅的問題所引起的。你會看到一些公司內部出現裁員，而且相對於一些早期研發而言，研發進度普遍放緩，這就是我們的感受。我們認為，這只是暫時的，它會自行解決。但我想說，我們仍然預計該產品今年的銷售量將保持平穩或略有成長。我的意思是，我們仍然——並不是說產品處於困境之中。

It's just that we had pipelines earlier in the year that showed that product performing much better than how it's ultimately performing. But year-over-year, I expect it to still be flat to even out some growth. But the explosive growth in MRD is on track. And that's what we're seeing. I don't think it's terribly a bit different than what other companies have seen.

只是我們在今年早些時候的管道顯示該產品的表現比最終表現要好得多。但與去年同期相比，我預計它仍將保持平穩，並實現一定的成長。但 MRD 的爆炸式增長仍在繼續。這就是我們所看到的。我認為這與其他公司所見的並沒有太大的不同。

We thought we would grow through it earlier in the year, but it sort of deepened as the quarter went on, and we felt like it was prudent to adjust the guidance given where we are.

我們以為我們會在今年稍早克服這個困難，但隨著本季的進行，困難加深，我們認為根據目前的狀況調整指導是明智之舉。

Okay. And the next question is on trying to understand, in terms of the Tempus relationship and also how the reimbursement can provide a boost to the sales in Q4 if you get at least one, if not two, both of the reimbursements in place. So, let's say, you get the reimbursement earlier in the quarter, in the fourth quarter. So, by the end of the quarter, would you be able to recognize the reimbursement amount? Or is there some additional paperwork and all that logistics that need to happen that you think could drag into the first quarter where you can actually really see the benefit of that reimbursement?

好的。下一個問題是試圖了解，就 Tempus 關係而言，以及如果至少獲得一項（如果不是兩項）報銷，報銷將如何促進第四季度的銷售。假設您在本季度早些時候，即第四季度收到了報銷。那麼，到本季末，您能確認報銷金額嗎？或者，您是否認為需要進行一些額外的文書工作和所有後勤工作，這些工作可能會拖到第一季度，到那時您才能真正看到報銷的好處？

I'm just trying to understand how the logistics work in terms of really recognizing the revenue based on the reimbursement.

我只是想了解物流在根據報銷真正確認收入方面的運作方式。

Yes. So RK, this is Aaron. In terms of some of the mechanics of it, we won't go into a lot of depth or detail here. But what's the most important fact here is that we do get a favorable coverage decision from Medicare, right? That's what we're after.

是的。那麼 RK，這是 Aaron。對於它的一些機制，我們不會在這裡深入或詳細地討論。但這裡最重要的事實是，我們確實從醫療保險中獲得了有利的承保決定，對嗎？這就是我們所追求的。

Assuming we get a favorable coverage from Medicare, right, for two cancer types, our guide is $3 million to $6 million, right? So, depending upon the timing, the number of samples, the price, there is some variability between the $3 million and $6 million, and that's why we do have a range. But the key here is getting the favorable coverage.

假設我們能從醫療保險中獲得針對兩種癌症的優惠保險，我們的指導金額是 300 萬美元到 600 萬美元，對嗎？因此，根據時間、樣品數量和價格，300 萬美元到 600 萬美元之間存在一些差異，這就是我們有一個範圍的原因。但這裡的關鍵是獲得有利的報道。

Thank you. Ladies and gentlemen, this concludes the question-and-answer session and the conference of Personalis. Thank you for your participation. You may now disconnect your lines.

謝謝。女士們、先生們，問答環節和個人會議到此結束。感謝您的參與。現在您可以斷開線路了。