Adaptive Biotechnologies Corp (ADPT) 2024 Q2 法說會逐字稿

Good day and thank you for standing by. Welcome to the Adaptive Biotechnologies second quarter 2024 earnings call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Karina Calzadilla, Head of Investor Relations. Please go ahead.

美好的一天，感謝您的支持。歡迎參加 Adaptive Biotechnologies 2024 年第二季財報電話會議。（操作員指示）請注意，今天的會議正在錄製中。現在我想將會議交給今天的第一位發言人，投資者關係主管卡琳娜·卡爾薩迪拉 (Karina Calzadilla)。請繼續。

Thanks, Anton, and good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies second quarter 2024 earnings conference call. Earlier today, we issued a press release reporting Adaptive financial results for the second quarter of '24.

謝謝安東，大家下午好。歡迎您參加 Adaptive Biotechnologies 2024 年第二季財報電話會議。今天早些時候，我們發布了一份新聞稿，報告了 2024 年第二季的自適應財務表現。

The press release is available at www.adaptivebiotech.com. We are conducting a live webcast of this call and will be referencing to a slide presentation that has been posted to the Investors section of our corporate website.

新聞稿可在 www.adaptivebiotech.com 上取得。我們正在對本次電話會議進行網路直播，並將參考已發佈在我們公司網站投資者部分的幻燈片演示。

During this call, management will make projections and other forward-looking statements within the meaning of federal security laws regarding future events and the future financial performance of the company. These statements reflect management's current perspective of the business as of today.

在這次電話會議中，管理階層將就聯邦安全法意義內的未來事件和公司未來的財務表現做出預測和其他前瞻性陳述。這些陳述反映了管理層目前對業務的看法。

Actual results may differ materially from today's forward-looking statements depending on a number of factors which are set forth in our public filings with the SEC and listed in this presentation. In addition, non-GAAP financial measures will be discussed during the call and a reconciliation from non-GAAP to GAAP metrics can be found in our earnings release. Joining the call today are Chad Robins, our CEO and Co-Founder; and Kyle Piskel, our Chief Financial Officer. Additional members from management will be available for Q&A.

實際結果可能與今天的前瞻性陳述有重大差異，具體取決於我們向美國證券交易委員會提交的公開文件中列出並在本簡報中列出的許多因素。此外，電話會議期間將討論非 GAAP 財務指標，並且可以在我們的收益發布中找到從非 GAAP 指標到 GAAP 指標的調整表。今天加入電話會議的是我們的執行長兼聯合創始人查德羅賓斯 (Chad Robins)；以及我們的財務長凱爾‧皮斯克爾 (Kyle Piskel)。管理層的其他成員將可以參加問答。

With that, I'll turn the call over to Chad Robins. Chad?

這樣，我會將電話轉給查德·羅賓斯。查德?

Thanks, Karina. Good afternoon, everyone, and thank you for joining us on our second quarter earnings call. It is Seafair Weekend here in Seattle, so if the Blue Angels are flying overhead, we are live and I may pause for a couple of seconds. Let's jump in. Our second quarter results are extremely encouraging. We are laser focused on fueling growth on the top line, reducing spend, and managing our capital, and this is exactly what we achieved this quarter as you can see on slide 3.

謝謝，卡琳娜。大家下午好，感謝您參加我們的第二季財報電話會議。現在是西雅圖的 Seafair 週末，所以如果藍天使從頭頂飛過，說明我們正在直播，我可能會暫停幾秒鐘。讓我們跳進去吧。我們第二季的業績非常令人鼓舞。我們專注於推動收入成長、減少支出和管理我們的資本，這正是我們本季的成就，如您在投影片 3 中看到的那樣。

MRD revenue grew 36% versus prior year and 8% versus prior quarter with growth coming from both clinical and pharma. Total operating spend less onetime costs had a significant decline of 15% versus prior year and 8% sequentially with reductions observed across all segments. Sequencing gross margin increased 5 percentage points compared to last quarter and cash ended at approximately $292 million. This reflects a cash burn reduction of 32% in the first half of this year, versus a year ago.

MRD 營收較上年成長 36%，較上一季成長 8%，成長來自臨床和製藥。扣除一次性成本後的總營運支出較上年大幅下降 15%，較上季下降 8%，所有細分市場均下降。定序毛利率較上季成長 5 個百分點，現金約 2.92 億美元。這反映出今年上半年的現金消耗比去年同期減少了 32%。

As a result of this strong performance, we are updating our full year guidance. We are raising our MRD revenue range, decreasing our operating spend and reducing our annual cash burn. Kyle will provide further details in his prepared remarks.

由於這種強勁的表現，我們正在更新全年指導。我們正在提高 MRD 收入範圍，減少營運支出並減少年度現金消耗。凱爾將在他準備好的演講中提供更多細節。

Now let's take a closer look at the MRD business on slide 4. clonoSEQ clinical revenue grew 43% versus prior year, driven by both volume and ASP. Test delivered had another record quarter, growing 36% versus prior year and 9% versus prior quarter to over 18,500 tests.

現在讓我們仔細看看幻燈片 4 上的 MRD 業務。交付的測試數量再創新高，與去年同期相比增長了 36%，與上一季相比增長了 9%，測試數量超過 18,500 次。

We observed double digit growth sequentially in all marketed indications. Multi-myeloma continues to be the largest contributor, representing 42% of volume. Importantly, non-Hodgkin's lymphoma now contributes 11% of clonoSEQ tests with DLBCL growing at 25% quarter-over-quarter.

我們觀察到所有上市適應症均連續兩位數成長。多發性骨髓瘤仍是最大的貢獻者，佔總量的 42%。重要的是，非何杰金氏淋巴瘤目前佔 clonoSEQ 測試的 11%，而 DLBCL 則是環比成長 25%。

Blood-based testing continues to be a focal point of our strategy, currently representing 40% of tests with multi-myeloma in blood at 21% versus 16% a year ago. We expect our planned launch in mantle cell lymphoma, coupled with continued promotion of expanding evidence for utility of blood and other disease states to be key drivers of clonoSEQ testing in blood during the second half.

血液檢測仍是我們策略的重點，目前佔血液中多發性骨髓瘤檢測的 40%，這一比例為 21%，而一年前為 16%。我們預計，我們計劃在套細胞淋巴瘤中推出，再加上繼續推廣血液和其他疾病狀態的用途的證據，將成為下半年 clonoSEQ 血液檢測的關鍵驅動力。

EMR integration remains an important area of investment for the MRD business, both as a future growth accelerant and as an additional competitive moat for our business. We are now live with six accounts in Epic and have 13 more in progress. We remain confident that we will have completed Epic integrations with 20 or more accounts by year end. Notably, in the second half of this year, our integration activities will expand beyond Epic with the planned Q4 kickoff to our onco EMR integration work with Flatiron Health.

EMR 整合仍然是 MRD 業務的重要投資領域，既可以作為未來成長的促進劑，也可以作為我們業務的額外競爭護城河。目前，我們在 Epic 中擁有 6 個帳戶，還有 13 個帳戶正在開發中。我們仍然有信心在年底前完成與 20 個或更多帳戶的 Epic 整合。值得注意的是，今年下半年，我們的整合活動將擴展到 Epic 以外的領域，並計劃於第四季度啟動與 Flatiron Health 的 onco EMR 整合工作。

On the reimbursement front, we continue to reduce out of policy and non-contracted claims and optimize revenue cycle management to drive ASP growth, which increased 3% in Q2 versus Q1. Results through the first half of the year, coupled with a preliminary gap-fill rate set by Medicare, further solidifies our confidence to grow ASP by $200 per test by the end of 2025.

在報銷方面，我們繼續減少保單外和非合約索賠，並優化收入周期管理，以推動平均售價成長，第二季度較第一季成長 3%。今年上半年的結果，加上 Medicare 設定的初步缺口填補率，進一步堅定了我們在 2025 年底將每次測試 ASP 提高 200 美元的信心。

Looking at MRD Pharma on slide 5. Our pharma business had another strong quarter with revenue growth of 28% versus prior year, which included a $3 million milestone from a drug approval multi-myeloma. This momentum comes on the heels of the ODAC announcement last quarter, which voted in favor of using MRD as a primary endpoint to support accelerated approval of new therapies in multi-myeloma. We are already seeing positive impact post this recommendation.

檢視投影片 5 上的 MRD Pharma。我們的製藥業務又迎來了一個強勁的季度，營收比去年同期成長了 28%，其中包括多發性骨髓瘤藥物核准的 300 萬美元里程碑。這一勢頭緊隨上季度 ODAC 公告之後而來，該公告投票支持使用 MRD 作為主要終點，以支持加速批准多發性骨髓瘤新療法。我們已經看到此建議的正面影響。

In the past few months, we have booked two new studies and are in advanced discussions for another three new studies where the decision to use MRD as a primary endpoint was made based on the ODAC outcome. Additionally, two existing studies have converted MRD from a secondary endpoint to a primary endpoint and we are in talks with partners about another four studies already underway that may also upgrade.

在過去的幾個月中，我們預訂了兩項新研究，並正在對另外三項新研究進行深入討論，其中使用 MRD 作為主要終點的決定是根據 ODAC 結果做出的。此外，現有的兩項研究已將 MRD 從次要終點轉變為主要終點，我們正在與合作夥伴就已經在進行的另外四項研究進行談判，這些研究也可能會升級。

Importantly, we are also seeing a positive halo effect for the continued acceptance of MRD in other disease states as our partners increasingly seek to incorporate MRD as a primary endpoint in CLL and DLBCL. As the only FDA cleared MRD assay that can consistently deliver the sensitivity and standardization needed to meet the FDA’s performance standards, we are confident that clonoSEQ will continue to be the test of choice not only for multi-myeloma drug developers, but also in other lymphoid malignancies.

重要的是，隨著我們的伴侶越來越多地尋求將 MRD 作為 CLL 和 DLBCL 的主要終點，我們也看到了在其他疾病狀態下繼續接受 MRD 的正面光環效應。作為唯一獲得 FDA 批准的 MRD 檢測方法，能夠始終如一地提供滿足 FDA 性能標準所需的靈敏度和標準化，我們相信 clonoSEQ 將繼續成為選擇的檢測方法，不僅是多發性骨髓瘤藥物開發人員的選擇，也是在其他淋巴惡性腫瘤。

Now let’s turn to immune medicine on slide 6. We’re making good progress in R&D towards the discovery and future development of differentiated immune-based therapeutics in cancer and autoimmunity. In oncology, we continue to work closely with Genentech and our cancer cell therapy programs.

現在讓我們轉向幻燈片 6 上的免疫醫學。我們在癌症和自體免疫疾病的差異化免疫療法的發現和未來開發方面取得了良好的研發進展。在腫瘤學方面，我們繼續與基因泰克和我們的癌細胞治療計畫密切合作。

Both companies are excited and committed to deliver high impact TCR -- TCR based cell therapy products to as many cancer patients as possible and we will provide an update at the appropriate time. In autoimmunity, we have successfully identified a subset of auto reactive T-cell receptors that are likely causing devastating disease in patients with MS, T1D and several others.

兩家公司都很興奮，並致力於向盡可能多的癌症患者提供高影響力的 TCR——基於 TCR 的細胞治療產品，我們將在適當的時候提供最新資訊。在自體免疫領域，我們已經成功鑑定出一部分自體反應性 T 細胞受體，這些受體可能會導致 MS、T1D 和其他幾種疾病患者出現毀滅性的疾病。

This quarter, we started our target -- target discovery efforts in T1D. As we did in multiple sclerosis, our goal is to identify the protein to which these auto-reactive or problem TCRs bind. This helps de-risk our assumptions and confirm that the disease biology makes sense.

本季度，我們開始了我們的目標—T1D 的目標發現工作。正如我們在多發性硬化症中所做的那樣，我們的目標是識別這些自身反應性或有問題的 TCR 所結合的蛋白質。這有助於降低我們的假設風險並確認疾病生物學是有意義的。

Also this quarter, we successfully completed our first antibody mouse immunization campaign, wave 1, in our lead autoimmune indications including multiple sclerosis and type 1 diabetes. By year end, we aim to identify and make a subset of antibodies to start functionally testing these candidates.

同樣在本季度，我們成功完成了我們的第一個抗體小鼠免疫活動，即第一波，針對我們的主要自體免疫適應症，包括多發性硬化症和第 1 型糖尿病。到年底，我們的目標是識別並製造一部分抗體，以開始對這些候選藥物進行功能測試。

Now I’m going to pass it over to Kyle to walk through the financial results and guidance update. Kyle?

現在我將把它交給凱爾，讓他詳細介紹財務表現和指導更新。凱爾？

Thanks, Chad. Let’s start with revenue for the second quarter on slide 7. Total revenue in the second quarter was $43.2 million with 82% from MRD and 18% from immune medicine. MRD revenue grew to $35.3 million, up 36% from a year ago, with clonoSEQ clinical testing and MRD pharma partnerships, each driving approximately 66% and 34% of the growth, respectively.

謝謝，查德。讓我們從幻燈片 7 上第二季的收入開始。第二季總收入為 4,320 萬美元，其中 82% 來自 MRD，18% 來自免疫藥物。MRD 營收成長至 3,530 萬美元，年增 36%，其中 clonoSEQ 臨床測試和 MRD 製藥合作夥伴關係分別推動了約 66% 和 34% 的成長。

Excluding the $3 million in regulatory milestones recognized this quarter, MRD revenue grew 25% from a year ago. Immune medicine revenue was $7.9 million, down 66% from a year ago, driven by an anticipated 82% decrease in Genentech upfront amortization and no related milestone in the quarter versus $7.7 million in milestone revenue recognized in Q3 -- Q2 of 2023. This decrease was partially offset by a 12% increase in immune medicine pharma services.

不包括本季確認的 300 萬美元監管里程碑，MRD 營收較去年同期成長 25%。免疫藥物收入為790 萬美元，比去年同期下降66%，這是由於基因泰克的預付攤銷預計減少82%，且本季沒有相關里程碑，而2023 年第三季至第二季確認的里程碑收入為770 萬美元。這一下降被免疫醫學製藥服務 12% 的成長部分抵消。

Moving down to P&L, I want to highlight that sequencing margin, which excludes the MRD milestones and Genentech amortization, was 50% for the quarter, an increase of 7 percentage points versus prior year and 5 percentage points sequentially.

談到損益表，我想強調的是，本季的定序利潤率（不包括MRD 里程碑和Genentech 攤銷）為50%，比前一年增加了7 個百分點，比上一季增加了5 個百分點。

The sequencing margin increase was mainly attributed to lower overhead costs from improvements in the production lab, driving lower cost per sample. Excluding one-time costs from asset impairment and severance related to restructuring initiatives, post strategic review, total operating spend, inclusive of cost of revenue, was $82.6 million, representing a 15% decrease from last year.

定序利潤的增加主要歸因於生產實驗室改進帶來的間接成本降低，從而降低了每個樣本的成本。不包括資產減損和與重組措施相關的遣散費的一次性成本、策略審查後的總營運支出（包括收入成本）為 8,260 萬美元，比去年下降 15%。

This decrease was mainly driven by the continued emphasis on driving leverage across functions with R&D being the biggest contributor of such decline, driven by more targeted investments in immune medicines. As you can see from the segment reporting table on the right side of the slide, MRD adjusted EBITDA was a loss of $11.3 million this quarter, a deficit that was reduced by 35% from the first quarter, driven by both higher revenue and lower operating expense.

這一下降主要是由於持續強調推動跨職能槓桿作用，而研發是這種下降的最大貢獻者，這是由對免疫藥物更有針對性的投資所推動的。從投影片右側的分部報告表可以看出，本季 MRD 調整後的 EBITDA 虧損 1,130 萬美元，在收入增加和營運下降的推動下，赤字比第一季減少了 35%費用。

I mean, medicine adjusted EBITDA loss remained flat sequentially as reductions in operating expenses were offset by lower Genentech revenue. Total company adjusted EBITDA was a loss of $21.4 million in the second quarter compared to a $28.2 million in the first quarter of 2024 and $24.8 million a year ago.

我的意思是，醫藥調整後的 EBITDA 虧損與上一季持平，因為營運費用的減少被基因泰克收入的下降所抵消。第二季公司調整後 EBITDA 總額虧損 2,140 萬美元，而 2024 年第一季虧損 2,820 萬美元，一年前虧損 2,480 萬美元。

Finally, interest expense from a royalty financing agreement with [OrbiMed] was $2.7 million, which once again was more than offset by interest income. Net loss for the quarter was $46.2 million, or $38.4 million excluding one-time asset impairment and restructuring charges compared to $47.8 million last year.

最後，與 [OrbiMed] 簽訂的特許權使用費融資協議產生的利息費用為 270 萬美元，再次被利息收入所抵銷。本季淨虧損為 4,620 萬美元，扣除一次性資產減損及重組費用後淨虧損為 3,840 萬美元，而去年同期淨虧損為 4,780 萬美元。

Now turning to our updated full year guidance on slide 8. We are increasing our MRD full year revenue guidance from a prior range of $135 million to $140 million to now $140 million to $145 million. This increase in guidance reflects the better than expected results in the second quarter, inclusive of the regulatory milestone realized.

現在轉向幻燈片 8 上更新的全年指引。我們將 MRD 全年營收指引從先前的 1.35 億美元至 1.4 億美元提高到現在的 1.4 億美元至 1.45 億美元。指導值的增加反映出第二季的業績優於預期，其中包括實現的監管里程碑。

With respect to trends throughout the second half, we expect MRD revenue to be about $45 million, $55 million weighted between the third and fourth quarter respectively. We are also further reducing the total company estimated operating spend excluding one-time restructuring and asset impairment charges from our previous range of $350 million to $360 million to now $340 million to $350 million. A $10 million reduction as we continue to drive leverage across the business and manage investments. Of this total spend approximately 70% comes within the MRD business and approximately 25% within immune medicine.

就整個下半年的趨勢而言，我們預計第三季和第四季加權後的 MRD 收入分別約為 4,500 萬美元和 5,500 萬美元。我們還將進一步降低公司預計營運支出總額（不包括一次性重組和資產減損費用），從先前的 3.5 億至 3.6 億美元範圍減少到現在的 3.4 億至 3.5 億美元。由於我們繼續提高整個業務的槓桿率並管理投資，因此減少了 1000 萬美元。其中約 70% 的支出用於 MRD 業務，約 25% 用於免疫醫學。

In addition, we are lowering our expected annual cash burn. We now expect the burn to be approximately $60 million for the second half of the year. This implies an annual cash burn of $115 million versus our previous estimate of $130 million and represents a 24% reduction over full year of 2023.

此外，我們正在降低預期的年度現金消耗。我們現在預計下半年的燒錢額約為 6000 萬美元。這意味著年度現金消耗為 1.15 億美元，而我們先前估計為 1.3 億美元，比 2023 年全年減少 24%。

We continue to expect approximately 50% of the cash burn this year to come from the MRD business and approximately 40% from immune -- immune medicine business. The remaining 10% is due to unallocated corporate costs. I look forward to providing you with further financial updates throughout the year as we continue diligent trajectory of strengthening our financial profile.

我們仍預計今年約 50% 的現金消耗將來自 MRD 業務，約 40% 來自免疫藥物業務。剩下的 10% 是由於未分配的企業成本。隨著我們繼續努力加強我們的財務狀況，我期待全年為您提供進一步的財務更新。

With that, I’ll hand it back over to Chad.

說完，我會把它交還給查德。

Thanks, Kyle. I am encouraged by the team’s execution in the first half of the year. We will continue to drive revenue growth in our MRD business and advance our focused programs in immune medicine. We will do this with disciplined spend and targeted investments to enhance long-term value. With that, I’d like to turn the call back over to the operator and open up the call for questions.

謝謝，凱爾。我對團隊上半年的執行力感到鼓舞。我們將繼續推動 MRD 業務的營收成長，並推進我們在免疫醫學領域的重點項目。我們將透過嚴格的支出和有針對性的投資來實現這一目標，以提高長期價值。這樣，我想將電話轉回給接線員並打開電話詢問問題。

Thank you. At this time we will conduct a question and answer session. (Operator Instructions)

謝謝。這時我們將進行問答環節。（操作員說明）

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

Hey, guys. Congrats on a strong beat and raise quarter. I guess my first question, which I find quite interesting is the number of new studies that are moving to primary endpoints. You talked about two new studies I believe in Q2, you're advanced in three more. I think in the past, I've heard you say that the level of economics can be roughly two times greater for a primary versus a secondary endpoint. Can you maybe just clarify that in terms of just the unit economics?

嘿，夥計們。恭喜季度的強勁表現和加薪。我想我的第一個問題是轉向主要終點的新研究的數量，我覺得這個問題非常有趣。我相信你在第二季度談到了兩項新研究，你在另外三項研究中取得了進展。我想在過去，我聽你說過，主要終點與次要終點的經濟水準大約是次要終點的兩倍。您能否僅從單位經濟效益方面澄清這一點？

Yeah, I mean, I think what you’re referring to is the milestone revenue that we could realize from the studies. And I think that is where you see that delta as it relates to the economics. I think as it relates to these studies and the bookings of these studies.

是的，我的意思是，我認為你指的是我們可以從研究中實現的里程碑收入。我認為這就是你看到與經濟相關的三角洲的地方。我認為這與這些研究和這些研究的預訂有關。

I just think we continue to expect that will be a 2025 tailwind and 2024 where we’re really focused on, executing the bookings and growing the backlog as we exit the year. So I think as it relates to unit -- unit economics, I think that primarily escalate the milestones, but it may catalyze some sequencing revenue faster than we (inaudible)

我只是認為我們繼續預計這將是 2025 年的順風車，而 2024 年我們將真正專注於執行預訂並在年底時增加積壓訂單。因此，我認為，由於它與單位經濟學相關，我認為這主要是升級里程碑，但它可能會比我們更快地催化一些定序收入（聽不清楚）

Okay, that’s helpful. And then I found it interesting that there’s a group working with the FDA in additional disease states. I think you called up CLL and DLBCL. Do you have any sense for timing there? And give us a sense for -- are you involved in this discussion or this group? Maybe just walk us through some of the stakeholders and how you think about this playing out over the coming months?

好的，這很有幫助。然後我發現有趣的是，有一個小組與 FDA 在其他疾病州合作。我想你打電話給了 CLL 和 DLBCL。你有時間觀念嗎？讓我們了解一下—您參與了這個討論或這個小組嗎？也許只是向我們介紹一些利害關係人，以及您如何看待未來幾個月的情況？

Yeah. First Mark, thanks for the question and the compliments on the quarter. Appreciate it. We -- a lot of our investigators, our principal investigators that we work with, are involved in those conversations and they’re asking us to provide for clonoSEQ data to help support them in those discussions. Very much like we did in multi-myeloma with the International Myeloma Working Group and others as they presented to the ODAC committee.

是的。首先，馬克，感謝您的提問和對本季的讚揚。欣賞它。我們——我們的許多研究人員，我們合作的主要研究人員，都參與了這些對話，他們要求我們提供 clonoSEQ 數據，以幫助支持他們進行這些討論。就像我們與國際骨髓瘤工作組和其他人在多發性骨髓瘤方面所做的一樣，他們向 ODAC 委員會提交了報告。

Excellent. Maybe last one for me. I don’t know if this was in your deck or not, but I think you’ve talked about approximately 60 clinical studies for multiple myeloma. And if I have it right, you had six as primary, looks like that number now is eight, three are in advanced discussions, that could be eleven. I think as we think about this longer term, where could that 10 or 11, where do you think that might go, looking out, say, two years to three years from today?

出色的。也許對我來說是最後一張。我不知道這是否在您的演講中，但我認為您已經談論過大約 60 項針對多發性骨髓瘤的臨床研究。如果我沒記錯的話，你們有六個作為主要成員，看起來現在的數字是八個，三個正在高級討論中，可能是十一個。我認為，當我們考慮這個更長期的問題時，從今天起兩年到三年，您認為這 10 或 11 個可能會走向何方？

It’s hard to put a number on that. Obviously, we believe that number is going to go up and hopefully up significantly. But I’d be -- hard pressed to start making those projections. Once we get a little bit farther into this, maybe you can -- kind of a year down the road. We could -- we could have better visibility into making those projections, Mark.

很難給出具體數字。顯然，我們相信這個數字將會上升，並有望大幅上升。但我很難開始做出這些預測。一旦我們更深入地研究這個問題，也許你可以——大約一年後。我們可以——我們可以更了解這些預測，馬克。

Okay. That's it for me. Thanks, guys.

好的。對我來說就是這樣。謝謝，夥計們。

Okay. Thank you.

好的。謝謝。

David Westenberg, Piper Sandler.

大衛‧韋斯特伯格，派珀‧桑德勒。

Hi. Thank you for taking the question. And congrats you on the big cost reduction burn and the MRD beat. So, Chad, I hate to ask this question because like I -- we should be celebrating your achievements in reducing the OpEx.

你好。感謝您提出問題。恭喜您大幅降低成本並實現 MRD 目標。所以，查德，我不想問這個問題，因為像我一樣，我們應該慶祝您在降低營運支出方面取得的成就。

Is there any -- you got any -- is there any risk here that you maybe went too lean and that this could hurt the top line growth, particularly on that MRD business? I don’t know. Maybe I would ask, in addition to that, do you actually think you could accelerate the revenue if you did add reps to that business or do you anyway, I’ll stop there.

是否存在任何——你有任何——這裡是否存在任何風險，即你可能過於精簡，這可能會損害營收成長，特別是在 MRD 業務方面？我不知道。除此之外，也許我會問，如果您確實為該業務增加了代表，您是否真的認為您可以加速收入成長，或者無論如何，我就到此為止。

Yeah. No, I think the sales and marketing, just, David, were untouched, relatively untouched, except for -- where we always manage our performance. We’re talking about a lot within the business with kind of G&A, overhead and just looking at every nook and cranny to be able to kind of reduce our expenses. So the answer is no. And where we are adding is in kind of our market access team. If you look at coverage and collections, these are particular areas of focus to us, which we continue to make investments in, where we believe that we can up the ASP and essentially kind of cash coming into the business.

是的。不，我認為銷售和行銷，大衛，沒有受到影響，相對沒有受到影響，除了——我們總是管理我們的績效。我們在業務中談論了很多關於一般管理費用、管理費用的內容，並且只是專注於每個角落，以便能夠減少我們的開支。所以答案是否定的。我們要增加的是我們的市場准入團隊。如果你看看覆蓋範圍和收款情況，你會發現這些是我們特別關注的領域，我們將繼續在這些領域進行投資，我們相信我們可以提高平均售價，並本質上為業務帶來現金。

But we will continue to kind of monitor reps and add reps as needed, and look at territory alignments as we do consistently. So we -- the final point is we look -- we’re looking across the board it ways that we can continue to first and foremost, make sure that we’re hitting our numbers and said another way that we’re de-risking the numbers. But it’s all about operating efficiencies without hurting the top line. And we saw -- we feel very comfortable that we’re making the right investments and the right moves.

但我們將繼續監控代表並根據需要添加代表，並像我們一貫所做的那樣關注區域調整。所以我們——最後一點是我們——我們正在全面尋找我們可以繼續首先也是最重要的方式，確保我們達到我們的目標，並用另一種方​​式說我們正在降低數字風險。但這一切都是為了在不損害營收的情況下提高營運效率。我們看到——我們感到非常放心，我們正在做出正確的投資和正確的行動。

Really, really, really appreciate that. Just -- I want to just talk about some of the potential for both operating leverage and cost reduction in clonoSEQ. I know you’ve made efforts in the past to kind of get some kind of cog reductions there.

真的，真的，真的很感激。只是——我想談談 clonoSEQ 在營運槓桿和降低成本方面的一些潛力。我知道你們過去曾努力減少一些齒輪。

Where are we at in terms of progress there? And then just in terms of -- are you getting some of that naturally, just via more volume through that product? And how should we think about gross margins over the kind of a three year, four year period or three year to five year period as this business becomes a lot more clinical MRD?

就進展而言，我們處於什麼位置？然後就而言——你是否透過增加該產品的銷量自然地獲得了一些？隨著這項業務變得更加臨床 MRD，我們應該如何考慮三年、四年或三年到五年期間的毛利率？

And I’ll stop there. I know there’s a lot of analysts that want to ask questions. Thank you.

我就到此為止。我知道有很多分析師想提出問題。謝謝。

Yeah, I mean, I think as it relates to our progress, I think as you’ve seen in the quarter and first half of the year, we’re continuing to gain leverage through some of the efficiency initiatives we’ve put in place, flattening out the org.

是的，我的意思是，我認為這與我們的進展有關，正如您在本季度和今年上半年所看到的那樣，我們將繼續透過我們已經採取的一些效率舉措來獲得影響力落實到位，精簡組織。

And yes, we are getting some of that naturally through increased volumes and increased revenue. And we’ll continue to see that in the back half of the year. I think we’re going to gain additional leverage back half of the year. I think I would say 3% to 5% improvement on that sequencing margin line. Over the long term, we have some initiatives going on. One of which is the NovaSeq, which we expect to launch the back half of 2025. And that can drive a lot of efficiencies.

是的，我們透過增加銷量和增加收入自然地獲得了其中的一些。我們將在今年下半年繼續看到這種情況。我認為我們將在今年下半年獲得額外的槓桿作用。我認為定序裕度線提高了 3% 到 5%。從長遠來看，我們正在採取一些措施。其中之一是 NovaSeq，我們預計將於 2025 年下半年推出。這可以提高很多效率。

And then again, as the last point, we’ve got to continue to do some work and continue to execute on the ASP line, and that’s going to drive a large amount of improvement to get us to that 70% target margin range that we see over three year to five year outlook.

話又說回來，作為最後一點，我們必須繼續做一些工作並繼續在 ASP 線上執行，這將推動大量改進，讓我們實現 70% 的目標我們預計三年至五年的利潤率範圍。

Thanks guys.

謝謝你們。

And as I said obviously -- the milestones will also continue to drive and support the business at the end of the day even absent the clinical performance, along with the pharma business, which I think ODAC only accelerates or makes that more durable growth over the longer term.

正如我顯然所說的那樣，即使沒有臨床表現，這些里程碑最終也將繼續推動和支持業務以及製藥業務，我認為 ODAC 只會加速或使業務增長在未來一段時間內更加持久。

Thank you so much. And again, congrats on -- on the big cost reduction curve and reduction and be.

太感謝了。再次恭喜—大幅降低成本曲線和降低成本。

Thank, Dave.

謝謝，戴夫。

Tejas Savant, Morgan Stanley.

Tejas Savant，摩根士丹利。

Hey, guys. Good evening. Thanks for the time here. Chad, I want to follow up on Mark’s question related to the ODAC guidance and so on. So first of all, when do you expect the FDA to finalize that in MM? And does that finalization have any sort of impact in terms of accelerating MRD endpoint adoption beyond what you’re seeing today in terms of that cadence -- in penetrating those potential trials? And then, on a related note, I think in the past you’ve talked about a little bit of a halo effect, if you will on the clinician side as well in terms of adopting clonoSEQ. So any color on that would be helpful.

嘿，夥計們。晚安.感謝您抽出寶貴時間來到這裡。Chad，我想跟進 Mark 提出的有關 ODAC 指南等問題。首先，您預計 FDA 何時會在 MM 中最終確定這一點？最終確定是否會對加速 MRD 終點採用（超越您今天所看到的節奏）（滲透這些潛在試驗）產生任何影響？然後，與此相關的是，我認為您過去曾談到過一點光環效應，如果您在臨床醫生方面也談到了採用 clonoSEQ 的話。所以任何顏色都會有幫助。

Sure. I’ll cover the first part, and then I’ll pass it over to Susan Bobulsky, the Chief Commercial Officer of the MRD Business to talk about kind of the impact and maybe give you some anecdotes as to what’s going on from a clinical perspective. As far as the ODAC vote, remember, this is the advisory council is a little bit different than it is, kind of for a drug approval.

當然。我將介紹第一部分，然後將其交給 MRD 業務首席商務官蘇珊·博布爾斯基 (Susan Bobulsky)，讓他談論影響的類型，也許還會給您一些有關正在發生的事情的軼事從臨床角度來講。就 ODAC 投票而言，請記住，這是一個與藥物批准有點不同的諮詢委員會。

And we’ve got in -- we've got some kind of messaging around, kind of the format that they’re going to kind of cement this decision as to whether it’s going to be kind of a formal white paper or come out as they kind of formal decision. There is a little bit -- there is little bit of debate as exactly how the FDA is going to. Obviously, it was a 12 to 0, overwhelmingly -- positive vote. So we don’t have a direct line as to exactly the timing of the format. But I will say this had no impact.

我們已經介入了——我們已經有了某種信息，某種形式，他們將鞏固這一決定，即它是否會成為一種正式的白色紙質文件或以正式決定的形式公佈。對於 FDA 的具體計劃，目前還存在一些爭論。顯然，這是 12 比 0，壓倒性的讚成票。因此，我們沒有關於格式的確切時間的直接資訊。但我會說這沒有影響。

Well, it’s had only a positive impact. Our pharma partners aren’t waiting in any way, shape or form. They know that the FDA on a -- for every drug approval that’s coming forward. They now have the opportunity to look at it as a primary endpoint based on this decision. The FDA is not waiting and neither are our pharma partners. So that’s a -- that’s why we’re already seeing the good trajectory that we have.

嗯，它只產生了正面的影響。我們的製藥合作夥伴不會以任何方式等待。他們知道 FDA 對每一項即將批准的藥物都會進行審批。他們現在有機會根據這項決定將其視為主要終點。FDA 不會等待，我們的製藥合作夥伴也不會等待。因此，這就是為什麼我們已經看到了良好的發展軌跡。

I do want to caution a little bit, and then Kyle mentioned this, but I’ll just -- it’s a great leading indicator, but it doesn’t necessarily impact 2024 revenue. It’s more, we’re seeing bookings that essentially, I would say, solidify the long-term kind of health of the pharma business going out into the future as those bookings convert into revenue opportunities, as those milestones are achieved and as more trials sign up, we get more sequencing revenue from those additional trials. Susan, can you provide perhaps some anecdotes of how you are seeing that -- those discussions in the clinic?

我確實想提醒一點，然後凱爾提到了這一點，但我只是——這是一個很好的領先指標，但它並不一定會影響 2024 年的收入。更重要的是，我想說，隨著這些預訂轉化為收入機會，隨著這些里程碑的實現和實現，我們看到的預訂基本上鞏固了製藥業務未來的長期健康狀況。的試驗註冊，我們從這些額外的試驗中獲得更多的測序收入。蘇珊，您能否提供一些您如何看待這一點的軼事——診所中的討論？

Sure. Thanks, Chad. Since the ODAC vote in April, we’ve increasingly seen clinicians are aware of that ODAC vote and they bring it up and view it favorably in the context of clinical conversations we’re having with them about MRD.

當然。謝謝，查德。自 4 月 ODAC 投票以來，我們越來越多地看到臨床醫生意識到 ODAC 投票，他們在我們與他們就 MRD 進行的臨床對話中提出並積極看待它。

The way that we’ve been framing it and I think this seems to resonate, is that -- by seeing the FDA’s vote of confidence behind MRD as a means to assess response to bring a drug into the market, that’s really an incredible amount of credibility that it lends to MRD as a marker for your individual patient.

我們一直在構建它的方式，我認為這似乎引起了共鳴，那就是——通過將 FDA 對 MRD 的信任投票視為評估將藥物推入市場的反應的手段，—— MRD 作為個體患者的標記確實具有令人難以置信的可信度。

We can predict the efficacy of that drug and approve it for marketing, then we can also predict the efficacy of that drug in your individual patient and you can use that to in firm conversations and dialogues with your patient. So I think that’s really resonating. Interestingly, another area where we see a lot of interest is in what we call the ID of patients.

我們可以預測該藥物的療效並批准其上市，然後我們還可以預測該藥物對您的個別患者的療效，您可以用它來與您的患者進行堅定的對話和對話。所以我認為這確實引起了共鳴。有趣的是，我們看到很多人感興趣的另一個領域是我們所謂的患者 ID。

In other words, the first step of clonoSEQ is to evaluate a high disease load sample and to identify the sequences that we will track for that patient’s MRD. And most physicians order ID tests when they decide they need their first MRD test. But in the context of pharma, increasingly anticipating use of MRD as an endpoint. There is an interesting synergy for our two businesses.

換句話說，clonoSEQ 的第一步是評估高疾病負荷樣本並確定我們將追蹤該患者 MRD 的序列。大多數醫生在決定需要進行第一次 MRD 檢測時都會進行 ID 檢測。但在製藥領域，人們越來越期待以 MRD 作為終點。我們兩家公司之間存在著有趣的綜效。

The pharma companies would love to see more and more patients being [IVed] for clonoSEQ testing at the time of diagnosis so that they are eligible for any trial that might come along and there is no delays or hurdles in finding an appropriate specimen to get them ID tested. Calibration rates, the rate of patients for whom we find viable sequences are also higher when we test fresh samples at diagnosis. And so pharma companies are essentially saying to us, it would be great if more and more accounts can do this ID testing upfront at the time of diagnosis.

製藥公司希望看到越來越多的患者在診斷時接受 clonoSEQ 測試，以便他們有資格參加可能進行的任何試驗，並且在找到合適的樣本時不會出現任何延誤或障礙。當我們在診斷時測試新鮮樣本時，校準率，即我們找到可行序列的患者的比率也更高。因此，製藥公司本質上是在對我們說，如果越來越多的帳戶能夠在診斷時預先進行身份測試，那就太好了。

And correspondingly, our accounts, particularly community accounts, where they are very eager to bring new groups of trials on board, are saying to us, hey, do you think that pharma companies would be more interested in working with us if we ID our patients upfront?

相應地，我們的帳戶，特別是社區帳戶，他們非常渴望引入新的試驗組，他們對我們說，嘿，你認為如果我們識別我們的患者，製藥公司會更有興趣與我們合作嗎？

And this is the strategy we’ve been pushing for a bit of time and we’re starting to see good traction but I think the ODAC is actually going to provide a tailwind to that strategy and bring more and more patients to be tested for a clonoSEQ ID at the time of diagnosis.

這是我們已經推動了一段時間的策略，我們開始看到良好的牽引力，但我認為 ODAC 實際上將為該策略提供推動力，讓越來越多的患者接受測試診斷時的 clonoSEQ ID。

And essentially that means they are MRD enabled from day one and they can get MRD testing whenever they need it in a trial, in the aclinic. So it seems like it’s a win-win-win for us, for pharma, for the clinic and the patient. And that’s something we’ve been talking very actively about and again seeing resonate.

從本質上講，這意味著他們從第一天起就啟用了 MRD，並且他們可以在試驗中或診所中隨時進行 MRD 測試。因此，這對我們、製藥公司、診所和患者來說似乎是三贏。這就是我們一直在非常積極地討論並再次引起共鳴的事情。

Got it. That’s super helpful. And then guys, couple more on the -- on the clinical side of things. So maybe for Kyle here, you talked about that $200 ASP increase over the next couple of years and you’re confident of getting there. You’ve also got that preliminary CLFS rate. I think it gets finalized on January 1 in 2025.

知道了。這非常有幫助。然後夥計們，更多關於臨床方面的事情。所以也許對於凱爾來說，您談到了未來幾年平均售價增加 200 美元，並且您有信心實現這一目標。您還可以獲得初步 CLFS 費率。我認為它會在 2025 年 1 月 1 日最終確定。

So could you just walk us through any color on the cadence of the ASP increases? I’m sure there’s a few moving parts beneath that, including perhaps some help from the biomarker bill, et cetera. Should it be front end loaded? Should it be relatively even keeled between where it is today. And then second, do you think from a commercial or physician education standpoint, you are where you need to be in the community setting today and it’s just a function of time or are there more investments to come on that front? Thank you.

那麼您能否向我們介紹一下 ASP 上漲節奏的任何顏色？我確信這背後有一些活動部分，可能包括生物標記法案的一些幫助，等等。應該前端加載嗎？它應該在今天的位置之間相對平穩嗎？其次，您是否認為從商業或醫生教育的角度來看，您今天在社區環境中處於需要的位置，這只是時間的函數，還是在這方面需要進行更多投資？謝謝。

Yeah. Hi, Tejas. I’ll take the question on ASP and then again I’ll pass it off to Susan to give you color on the clinical side. But from the -- our ASP acceleration plan is really comprised of three key pillars. Coverage, contracting and collections.

是的。嗨，特哈斯。我將回答有關 ASP 的問題，然後再次將其傳遞給 Susan，讓您了解臨床方面的情況。但從我們的 ASP 加速計畫來看，它實際上由三個關鍵支柱組成。覆蓋範圍、承包和收集。

So on the coverage side, we’re seeking Medicare coverage for a broader set of indications. We’re also exploring novel coverage structures including recurrence monitoring for selected indications. And that’s actually what we’ve already submitted and are in discussions on for our MCL. We’re actively reducing out of policy claims and have aligned our business to drive the core indications where we now have that solid coverage in place. And that -- that is or we can further kind of double click on that to look at how we modified our sales force incentive compensation plan. We also have kind of changes in ordering requirements for customers who wish to -- order the out of criteria test.

因此，在承保範圍方面，我們正在尋求醫療保險承保更廣泛的適應症。我們也正在探索新穎的承保結構，包括針對選定適應症的復發監測。這實際上就是我們已經提交並正在討論的 MCL 內容。我們正在積極減少保單索賠，並調整我們的業務以推動核心適應症，我們現在已經擁有了可靠的承保範圍。那就是，或者我們可以進一步雙擊它來查看我們如何修改我們的銷售人員激勵薪酬計劃。我們也對希望訂購不合格測試的客戶的訂購要求進行了一些更改。

And then the third component of that is really new operational policies that will increase the percentage of tests that we get paid for. And as a result of that we’ve seen a really positive shift in our mix towards contracted indications where those have really grown as a percentage of our mix. So that really covers the first pillar of coverage. The second one is contracting. So in that there is a couple things to talk about on contracting. First, we continue to negotiate agreements with our non-contracted payers.

第三個組成部分是真正的新營運政策，這將增加我們獲得報酬的測試百分比。因此，我們看到我們的組合向收縮適應症發生了真正積極的轉變，這些適應症在我們組合中所佔的比例確實有所增長。這確實涵蓋了覆蓋範圍的第一個支柱。第二個是承包。因此，關於合約有幾件事需要討論。首先，我們繼續與非簽約付款人談判協議。

The objective here is obviously to secure pricing at or above the Medicare price. And within that, we’ve already talked about this, but we expect the publication of that preliminary gap bill rate that to provide really meaningful leverage as we go out and have those conversations with payers. We can go reference that new rate as a benchmark to be set, that they have to be at or above that rate.

這裡的目標顯然是確保定價等於或高於醫療保險價格。其中，我們已經討論過這一點，但我們預計初步缺口帳單利率的公佈將在我們出去與付款人進行對話時提供真正有意義的槓桿作用。我們可以參考新的利率作為要設定的基準，它們必須等於或高於該利率。

A good example of that is one of the large outstanding payers with Anthem, which we’re waiting for that rate to go to Anthem and say this is what we expect or better. And then the third is in the area of -- I’ll just call it blocking and tackling with collections. And we’re taking a few different steps on collection performance.

一個很好的例子是 Anthem 的大額未付款項之一，我們正在等待 Anthem 的費率，並說這是我們所期望的或更好的。第三個領域是──我稱之為阻塞和處理集合。我們正在對收集性能採取一些不同的步驟。

The first is we continue to place like a real focus on Medicare Advantage collections. This has been a problem for the industry, which -- I think we’re starting to see some resolution on. There is these large claims projects that we’re going after and we’re directly engaging a CMS at a national level to help us support kind of this claim payment resolution with Medicare Advantage from the private payors.

首先，我們繼續真正關注 Medicare Advantage 系列。這一直是行業的問題，我認為我們已經開始看到一些解決方案。我們正在尋求這些大型索賠項目，並且我們直接與國家一級的 CMS 合作，幫助我們透過私人付款人的 Medicare Advantage 來支持這種索賠付款解決方案。

The second component of that is, just as -- I mentioned this in a prior question, but we’ve increased our resourcing allocated to claims management. So we actually have more people going after. I’ll call it smiling and dialing and there is actually more to it. We actually have some really nice AI projects for the appeals process and claims management. We put in place new initiatives on how we do prior authorizations, et cetera.

第二個組成部分是，正如我在先前的問題中提到的那樣，但我們增加了分配給索賠管理的資源。所以我們實際上有更多的人在追求。我稱之為微笑和撥號，實際上還有更多內容。實際上，我們有一些非常好的人工智慧專案用於上訴流程和索賠管理。我們就如何進行事先授權等製定了新措施。

And the final -- the final pillar of that is we’ve made some significant headway on the implementation of our PLA code and further progress, I think, will be supported by the new preliminary Medicare rate that we talked about. With that, Susan, do you want to comment on his question regarding clinical?

最後支柱是我們在實施 PLA 準則方面取得了一些重大進展，我認為進一步的進展將得到我們談到的新的初步醫療保險費率的支持。蘇珊，您想對他關於臨床的問題發表評論嗎？

Sure. I think you asked about whether or where we need to be in the community setting. Do we need to invest additionally? So over the last several quarters, you’ve seen somewhere between 20% and 25% of our business kind of coming consistently from that community segment. And we believe that over time that contribution can be much higher.

當然。我想你問的是我們是否需要在社區環境或哪裡。我們需要額外投資嗎？因此，在過去的幾個季度中，您會發現我們 20% 到 25% 的業務始終來自該社區部分。我們相信，隨著時間的推移，這種貢獻可能會更高。

We’ve actually seen some really nice acceleration in Q2 in our academic segment, in concert with continued study growth in the community. So we have a lot of feeling in both segments and so we can’t focus only on one at the expense of the other.

事實上，我們在第二季度看到學術領域出現了一些非常好的加速，與社區的持續研究成長一致。因此，我們對這兩個領域都有很多感情，因此我們不能只專注於一個領域而忽略另一個領域。

We have a lot of untapped potential to capture in both. But that said, winning in the community is going to be a long-term critical success factor for this (inaudible). But given the proportion of patients who are treated either entirely or partially in community settings and we -- our penetration is much lower in the community than it is in academic settings.

我們在這兩個方面都有很多尚未開發的潛力。但話雖如此，在社區中獲勝將成為長期成功的關鍵因素（聽不清楚）。但考慮到完全或部分在社區環境中接受治療的患者比例，以及我們在社區中的普及率比在學術環境中低得多。

So there’s a couple of things that we’ve done recently and then a few things that we will be starting to do, and we have plans to do in the coming months. So one of the things we’ve done recently is really re-orient our peer to peer educational programs and medical education programs and other types of sponsorship dollars that we invest towards physician education to really be focused on connecting thought leaders, both academic and community thought leaders who have mastered the use of MRD in their own practices to bring their playbooks to the community to show in a variety of ways, both written, verbal, how they are using MRD, because that is the number one question we get in the clinic.

因此，我們最近做了一些事情，然後我們將開始做一些事情，並且我們計劃在未來幾個月內做一些事情。因此，我們最近所做的一件事是真正重新調整我們的同儕教育計劃和醫學教育計劃以及我們投資於醫生教育的其他類型的贊助資金，真正專注於連接思想領袖，無論是學術界還是學術界。

And the data will continue to develop with some very nice data sets on actionability of MRD. But there’s a lot more in motion right now that we’ll read out over the next couple of years. So while we’re waiting on that, let’s show what the KOLs have really got comfortable with.

數據將繼續發展，一些關於 MRD 可操作性的非常好的數據集。但現在還有更多的事情正在發生，我們將在未來幾年內宣讀。因此，在我們等待的同時，讓我們展示一下 KOL 真正滿意的內容。

So it’s been a big area of focus and investment, as well as ensuring that we have the right team structure in place. So as you know, back at the beginning of 2022, we hired our first community sales team. And that team has been able to drive tremendous increases in contribution of that business.

因此，這是一個重點關注和投資的重要領域，並確保我們擁有正確的團隊結構。如您所知，早在 2022 年初，我們就聘請了第一個社區銷售團隊。該團隊已經能夠推動該業務的貢獻大幅增加。

We were only 5% community when they started, but we’ve also got a small team, what we call strategic accounts managers. And those folks are really the folks driving, G suite engagement in the oncology community practice networks or supergroups, which is where the majority of patients in the community are managed. And we recently -- we reorganized our strategic accounts team under a dedicated leader, which had a variety of strategic benefits.

當他們開始時，我們只有 5% 的社群成員，但我們也有一個小團隊，我們稱之為策略客戶經理。這些人確實是推動 G Suite 參與腫瘤學社區實踐網絡或超級組的人，這是社區中大多數患者的管理場所。最近，我們在一位專門的領導者的領導下重組了我們的策略客戶團隊，這具有多種策略優勢。

The other place where we are going to invest in the coming months and you’ve heard about this a little bit, is EMR integration oriented toward the community. So Flatiron is the big partnership we’ve discussed, but we have a number of ongoing or recently initiated integration projects or integration discussions and negotiations which will allow us to significantly increase our footprint for integration in the community

我們將在未來幾個月投資的另一個地方是面向社區的 EMR 集成，您已經聽說過這一點。因此，Flatiron 是我們討論過的大型合作夥伴關係，但我們有許多正在進行或最近啟動的整合項目或整合討論和談判，這將使我們能夠顯著增加我們在社區中的整合足跡

Got it. Super helpful. Appreciate all the color, guys. Thank you.

知道了。超有幫助。欣賞所有的顏色，夥計們。謝謝。

Just on the ASP increase, we’ve talked about the $200 increase over the course of the next two years. I think what we’re seeing from these ASP initiatives and what Chad is summarizing -- we’ve got strong confidence. We’ll start to see kind of some of the early evidence from this in the back half of the year. And the gap fill rate effectively gives us confidence heading into 2025 that we can continue to deliver that growth over the next few years.

就 ASP 的成長而言，我們已經討論了未來兩年內 200 美元的成長。我認為我們從這些 ASP 舉措中看到的以及乍得總結的內容——我們擁有堅定的信心。我們將在今年下半年開始看到一些早期證據。缺口填補率有效地讓我們對進入 2025 年充滿信心，相信我們可以在未來幾年繼續實現這一成長。

Thank you, Kyle. Appreciate it.

謝謝你，凱爾。欣賞它。

Dan Brennan, TD Cowen.

丹布倫南，TD·考恩。

Thanks for taking the questions. Congrats on the quarter. Maybe one just on the burn and the margin improvement. Could you just speak a little bit more towards kind of what went better in the quarter? You’re obviously taking down the guide or excuse me, improving the guide, just kind of what are you thinking about in the back half of the year from some of the line items about what’s getting better?

感謝您提出問題。恭喜本季。也許只是在燒錢和利潤改善方面。您能否多談談本季的進展？顯然，您正在取消指南，或者抱歉，正在改進指南，只是您在今年下半年從一些關於哪些方面變得更好的項目中想到了什麼？

Yeah, Dan, I would say, we’ve done a number of -- initiatives here to get the workforce aligned and spend aligned with where we think business should be. I think we’re going to continue to see leverage in that, in those areas, especially as it relates to the margin profile. We’re continuing to expect increased volumes both in the clinic and increased revenues in the pharma business. So we’re going to continue to see that leverage in the back half of the year.

是的，丹，我想說，我們已經在這裡採取了許多舉措，以使勞動力和支出與我們認為的業務應該一致。我認為我們將繼續在這些領域看到槓桿作用，特別是與利潤率相關的槓桿作用。我們繼續預計診所的銷售和製藥業務的收入都會增加。因此，我們將在今年下半年繼續看到這種槓桿作用。

And -- I think we’ve got some decent initiatives in place for 2025 that will continue to play out there. As it relates to the burn, I mean, again, I don’t want to sound like a broken record, but the restructuring initiatives we put in place over the first half of the year have led us to some increased confidence of the results of the reductions in spend to be confident that we can continue to reduce the burn and focus our investments in IM, which will yield benefits in the longer term. But as it relates to Q2, we had some significant collections across the business, the milestones being one of them, the pharma business and in the clinic.

而且，我認為我們已經為 2025 年制定了一些不錯的舉措，這些舉措將繼續發揮作用。就燒錢而言，我的意思是，我不想聽起來像是打破了記錄，但我們在今年上半年實施的重組舉措使我們對結果的信心增強了支出的減少讓我們有信心繼續減少開支，並將投資集中在IM 上，從長遠來看，這將產生效益。但就第二季而言，我們在整個業務中進行了一些重要的收集，里程碑就是其中之一，即製藥業務和診所。

So I think what we’re going to see in the course of the year is just a continued march down that path. There is a bit of seasonality in the back half of the year from a spend perspective, so that’s why it’s just a little bit slightly higher than the first half of the year

因此，我認為我們在這一年中將看到的只是沿著這條道路繼續前進。從支出角度來看，下半年存在一些季節性，因此這就是為什麼它比上半年略高一點

Got it. Okay, that sounds good. What about on the mean medicine side? Biotech funding has been healthier. I know that’s generally been a drag over the last period of time, a kind of a spending environment. Like, what are you guys seeing just from more of like a macro basis on that side of the business?

知道了。好吧，聽起來不錯。那麼在平均醫學方面呢？生物技術資金更加健康。我知道這在過去一段時間通常是一種拖累，一種消費環境。例如，你們從業務方面的宏觀基礎上看到了什麼？

Are you talking about from -- an IM pharma revenue perspective, Dan?

Dan，您是從 IM 製藥收入的角度談論的嗎？

Yeah, yeah, exactly. Sorry, Chad. Yeah.

是的，是的，完全正確。對不起，查德。是的。

Yeah. Just as a reminder to everyone, obviously we not -- we don’t report revenue based on that, but there has been kind of some impact. I think it depends on what our technology is being used for. Some of the very early kind of research and development budgets aren’t what they used to be, but we now have kind of longstanding relationships where we’ve been embedded and many different pharma companies are looking at the immunological response to the therapies and we’ve used in a variety of different contexts which I think it continues to hold up pretty well.

是的。提醒大家，顯然我們不會——我們不會據此報告收入，但確實產生了一些影響。我認為這取決於我們的技術的用途。一些非常早期的研發預算已經不再像以前那樣了，但我們現在已經建立了某種長期的關係，許多不同的製藥公司正在研究這些療法的免疫反應我們已經在各種不同的環境中使用過，我認為它仍然保持得很好。

Okay. And then maybe on DLBCL, I heard you say like 20% quarterly growth. I think sequentially it’s still; penetration is still fairly nascent. Like what -- how is that progressing versus expectations? Does that kind of keep going linearly or there an opportunity for any kind of acceleration there?

好的。然後也許在 DLBCL 上，我聽到你說季度成長 20%。我認為依序是靜止的；滲透率仍處於初步階段。比如——與預期相比，進展如何？這種情況是否會繼續線性進行，或者是否有機會進行任何形式的加速？

Yeah, I did. I’ll pass it over to Susan to answer that question. But it seems 25% sequence of growth. Susan, do you want to give some color on the trajectory?

是的，我做到了。我將把它交給蘇珊來回答這個問題。但似乎有25%的成長。蘇珊，你想為軌跡添加一些顏色嗎？

Sure. Yeah. So DLBCL is now up to 6% of our total business, clinical business, which is up from 3% a year ago. And it -- we’ve been please -- we've been hitting our internal projections with the indication level with DLBCL. So far we’ve been pleased to see significant uptake in the community setting.

當然。是的。因此，DLBCL 現在占我們臨床業務總業務的 6%，高於一年前的 3%。我們很高興地看到，我們一直在 DLBCL 的指示層級上達到我們的內部預測。到目前為止，我們很高興看到社區環境中的顯著採用。

And also, continued opportunities to report out new data. You may have noted that earlier in Q2 in May, we saw a really nice publication on clonoSEQ in DLBCL in the context of a study known as -- for a regimen known as ViPOR, the relapsed refractory regimen, it was published in the New England Journal of Medicine in May. And in that study, we saw really nice performance from the clonoSEQ assay in terms of the ability to differentiate patients who would have better or worse progression pre survival and overall survival.

此外，還有持續報告新數據的機會。您可能已經注意到，在5 月第二季度早些時候，我們在一項名為ViPOR 的治療方案（復發難治性治療方案）的研究背景下看到了一篇關於DLBCL 中clonoSEQ 的非常好的出版物，它發表在《新英格蘭》雜誌上五月醫學雜誌。在那項研究中，我們看到 clonoSEQ 檢測在區分生存前和總生存期進展更好或更差的患者方面具有非常好的性能。

In that study, 15 patients who achieved complete response at the end of therapy and remain progression free throughout the study, they all had MRD that was undetectable by clonoSEQ. And of those that progressed, three out of the four had detectable ctDNA prior to the evidence of relapse. So we saw another nice demonstration, albeit in a small patient population of the performance of the assay in a relapsed refractory setting. We continue to generate data and that will certainly be a catalyst for ongoing adoption as well as our ongoing work with regulatory agencies to expand access and to increase the utilization of DLBCL by pharma companies.

在該研究中，15 名患者在治療結束時獲得完全緩解，並且在整個研究過程中保持無進展，他們都具有 clonoSEQ 無法檢測到的 MRD。在出現進展的患者中，四分之三在復發證據出現之前就已檢測到 ctDNA。因此，我們看到了另一個很好的演示，儘管是在一小部分患者群體中，但在復發難治性環境中該測定的性能。我們不斷產生數據，這肯定會成為持續採用的催化劑，也將成為我們與監管機構持續合作的催化劑，以擴大 DLBCL 的使用範圍並提高製藥公司對 DLBCL 的利用率。

So actually, last week we submitted our DLBCL strike offering to New York state CLEP, which will expand the access to DLBCL in New York if approved. And we continue to work on our FDA submissions, which we expect to be useful both in the pharma setting and also have a (inaudible)

事實上，上週我們向紐約州 CLEP 提交了 DLBCL 罷工要約，如果獲得批准，將擴大紐約州 DLBCL 的使用範圍。我們將繼續致力於向 FDA 提交申請，我們希望這些申請不僅在製藥領域有用，而且還具有廣泛的應用前景。（聽不清楚）

Awesome. Thanks a lot and congrats.

驚人的。非常感謝並祝賀。

Thanks, Dan.

謝謝，丹。

Andrew Brackmann, William Blair.

安德魯·布拉克曼，威廉·布萊爾。

Hi, guys. Good afternoon. Thanks for taking the questions. Maybe just going back to the Epic integrations, it sounds like things are moving nicely there, but can you maybe just sort of talk about of those accounts who have integrated, just what you’re seeing in terms of any utilization uptick? And I guess, how should we be thinking about the impact here? Not necessarily just over the next couple of quarters, but more so over the next few years. Thank you.

嗨，大家好。午安.感謝您提出問題。也許回到 Epic 集成，聽起來事情進展順利，但您能否談談那些已經集成的帳戶，以及您在利用率上升方面看到的情況？我想，我們該如何考慮這裡的影響？不一定只是在接下來的幾個季度，但在未來幾年更是如此。謝謝。

Sure, Susan.

當然，蘇珊。

Yeah, sure. Yeah. So as Chad mentioned, we now have six sites integrated. Four of those have been integrated for about six months and then two are brand new in Q2. They have 13 others that are actively progressing towards the completion of the integration plus a variety of additional sites kind of in the funnel where they’ve been approved for waiting for the resources to be able to implement them on the account side. But the accounts that we started with were relatively smaller accounts. That we saw a very nice pickup almost immediately upon integration.

是的，當然。是的。正如查德所提到的，我們現在整合了六個站點。其中四個已經整合了大約六個月，然後兩個在第二季度是全新的。他們還有另外 13 個正在積極完成集成，此外還有渠道中的各種其他站點，它們已被批准等待資源能夠在帳戶端實施它們。但我們開始的帳戶相對較小。我們在整合後幾乎立即看到了非常好的拾取效果。

Double digit increases in adoption in test volumes just within a quarter. And also significant increases in the number of ordering providers, which reflects the ease of use of the integrated test. We also have seen some really nice improvements in operations. For example, the orders that come in through epic are less likely to have discrepancies that require follow up from our customer service team or more likely to have complete accurate billing information, which we need to submit successful claims or reimbursement.

短短一個季度內，測試量的採用率就出現了兩位數的成長。並且訂購提供者的數量也顯著增加，這反映了整合測試的易用性。我們也看到了營運方面的一些非常好的改進。例如，透過Epic收到的訂單不太可能出現需要我們的客戶服務團隊跟進的差異，或者更有可能擁有完整準確的帳單信息，我們需要這些資訊來提交成功的索賠或報銷。

And so a variety of nice benefits that we’ve seen in those accounts. But those first floor accounts were relatively small accounts intentionally, because we were just getting started. The two very recent accounts are accounts that are larger potential, but very early days from clonoSEQ adoption. So in this case, we’ll get to evaluate over the next 6 months to 12 months, whether EMR integration can accelerate sort of uptick from a nascent place in a larger potential account.

因此，我們在這些帳戶中看到了各種不錯的好處。但那些一樓的帳戶故意是相對較小的帳戶，因為我們才剛開始。最近的兩個帳戶潛力較大，但距離 clonoSEQ 採用還很早。因此，在這種情況下，我們將在接下來的 6 個月到 12 個月內評估 EMR 整合是否可以加速更大潛在客戶中的新興位置的成長。

We will have some of our largest current accounts going live by the end of 2024. And so I think that’s when we’re really going to be able to tell you that more about what we’ve learned about the impact on the business. But I will remind you that Epic integration was the strategy that we’ve had in mind for some time. And so we did built into our 2024 guidance for the clinical business some -- some increase in use based on the implementation of (inaudible)

到 2024 年底，我們的一些最大的經常帳戶將投入使用。因此，我認為到那時我們才真正能夠告訴您更多有關我們所了解的有關業務影響的信息。但我要提醒您的是，Epic 整合是我們已經考慮了一段時間的策略。因此，我們確實在 2024 年臨床業務指南中納入了一些內容——基於實施以下措施，使用量增加（聽不清楚）

Perfect. And then may be just on the LIMS overhaul, can you just level set us on where that initiative stands and just how we should be thinking about any impact to cost savings over the next couple of quarters in 2025? Thank you.

完美的。然後可能只是 LIMS 改革，您能否向我們介紹一下該計劃的進展情況，以及我們應該如何考慮 2025 年接下來幾季對成本節約的影響？謝謝。

Yeah. With regards to LIMS, I’d say we put that on the back burner to focus initiatives around, things that we can do to improve our workflows, namely in the reimbursement space as well as in the customer office space. So right now coming out of the strategic review and some of the restructuring initiatives, that was one of the projects. We’re deprioritizing at this time and reprioritizing other initiatives that we think have better near term ROI.

是的。關於 LIMS，我想說，我們把它放在次要位置，專注於圍繞我們可以做的事情來改進我們的工作流程，即報銷空間以及客戶辦公空間。因此，現在從策略審查和一些重組舉措中出來，這就是項目之一。我們目前正在取消優先級，並重新調整我們認為短期投資回報率更高的其他計劃的優先級。

Got it. Thanks, guys.

知道了。謝謝，夥計們。

Rachel Vatnsdal, JPMorgan.

雷切爾·瓦特斯達爾，摩根大通。

Perfect. Good afternoon guys. Thanks so much for taking the questions. So great to hear about the continued strength on MRD and then the cost savings as well. You previously had kind of talked about second half of 2025 EBITDA breakeven. So is that still the right way to think about it or we potentially see that timeline get moved up, given where you’re at from a cost based perspective?

完美的。各位下午好。非常感謝您提出問題。很高興聽到 MRD 的持續優勢以及成本節約。您之前曾談到 2025 年下半年 EBITDA 損益兩平。那麼，考慮到您從基於成本的角度來看，這仍然是正確的思考方式嗎？

I’d say that’s the right way to think about it right now. I mean, again, we’ll continue to monitor performance and -- as we get closer to 2025 update you at that point. But right now, that’s what we’re thinking about and that’s what we’re executing towards.

我想說這是現在思考這個問題的正確方式。我的意思是，我們將繼續監控效能，並在接近 2025 年時向您更新最新情況。但現在，這就是我們正在思考的，也是我們正在執行的目標。

Great. And then on my follow up, just on the COGS side of things, you mentioned NovaSeq in Dave’s earlier question. So can you walk us through the timing for that rollout and how we should think about the potential reduction in COGS? How quickly can that really kick in? And then where do you think you could get on a COGS per test with NovaSeq in that rollout there? Thanks.

偉大的。然後，在我的後續行動中，就 COGS 而言，您在 Dave 之前的問題中提到了 NovaSeq。那麼您能否向我們介紹一下推出的時間以及我們應該如何考慮銷售成本的潛在減少？這要多快才能真正發揮作用？那麼您認為在 NovaSeq 的每次測試中，您可以在哪裡獲得 COGS？謝謝。

We’re moving along in the development phase. It’s a pretty significant undertaking. So we’re going to be fairly cautious about getting this done and getting it right. But at the end of the day, we’re anticipating, back half of 2025, we can get this and again. We’ll see the initial uptake. But our anticipation is this could be between 5 percentage points to 8 percentage points.

我們正在開發階段繼續前進。這是一項相當重大的任務。因此，我們將相當謹慎地完成並正確完成這件事。但最終，我們預計 2025 年下半年，我們可以再次實現這一目標。我們將看到最初的採用情況。但我們的預期可能會在 5 個百分點到 8 個百分點之間。

And once we’re up and running and once we get in the workflow, we’ll have a little bit better data, but we’ll wait and see. But we think it’s a meaningful driver. We just need to make sure it’s done right.

一旦我們啟動並運行並進入工作流程，我們將獲得更好的數據，但我們將拭目以待。但我們認為這是一個有意義的驅動因素。我們只需要確保它做得正確。

Yeah. And as volumes continue to grow, that percentage in reduction in COGS will correspondingly grow. So that’s an initial estimate of kind of back half of 2025 cost reduction of 5% to 8% with upside from there.

是的。隨著銷售持續成長，銷貨成本減少的百分比也將隨之增加。因此，初步估計 2025 年下半年成本將降低 5% 至 8%，並有上升空間。

Sung Ji Nam, Scotiabank.

宋志南，豐業銀行。

Hi. Thanks for taking the questions. Just a couple of clarification questions on MRD pharma. For the $3 million milestone that you received, was that an accelerated, customer accelerating from secondary, I’m sorry, converting from secondary to primary endpoint in their study or was it just an acceleration since the ODAC in terms of implementing the trial, MRD as primary endpoint or is something different altogether?

你好。感謝您提出問題。只是關於 MRD Pharma 的幾個澄清問題。對於您收到的 300 萬美元里程碑，我很抱歉，客戶從次要終點加速，在他們的研究中從次要終點轉換為主要終點，或者只是自 ODAC 實施試驗以來的加速， MRD 作為主要終點還是完全不同？

No, it wasn’t result of the ODAC decision. This was a study that had been in play and just recently got approval. So nothing. It wasn’t tied (multiple speakers)

不，這不是 ODAC 決定的結果。這是一項一直在進行的研究，最近剛獲得批准。所以沒什麼。它沒有被束縛（多個發言者）

MRD data was used in the submission package. We again, not related to ODAC or endpoint.

MRD 資料用於提交包中。我們再次強調，與 ODAC 或端點無關。

Okay, got it. And then just on the again, on the MRD pharma side, are there customers that are currently that have currently incorporated flow cytometry based monitoring for MRD that might be interested in switching to clonoSEQ, given the better standardization that you talked about? Is that a potential opportunity and kind of curious if you might be getting any interest from those customers and hurdles from switching kind of a midway, if you will, in their studies, from one technique to another?

好的，明白了。另一方面，在 MRD 製藥方面，考慮到您提到的更好的標準化，目前是否有客戶目前已經採用基於流式細胞儀的 MRD 監測，可能有興趣轉向 clonoSEQ？這是一個潛在的機會，也是一種好奇，如果你可能會從這些客戶那裡得到任何興趣，並且在中途轉換時會遇到障礙，如果你願意，在他們的研究中，從一種技術轉向另一種技術？

Absolutely. There’s an opportunity to convert. I mean, with some already have and we’ve been converting them over the years, but certainly kind of with the ODAC decision, I think it continues to solidify the importance of NGS MRD with the depth of sensitivity, down to one in a million where as low as it go 1 to 10,000, without even the same level of standardization. So we continue to -- we continue to convert over those -- those pharma customers.

絕對地。有一個轉變的機會。我的意思是，有些已經有了，而且我們多年來一直在轉換它們，但肯定是 ODAC 的決定，我認為它繼續鞏固了 NGS MRD 的重要性，其敏感性深度下降到了四分之一低至1 到10,000 的單位，甚至沒有相同程度的標準化。因此，我們繼續——我們繼續轉化那些——那些製藥客戶。

Great. That’s it for me. Thank you.

偉大的。我就是這樣。謝謝。

Thanks, Sung Ji.

謝謝，宋吉。

Thank you. I am showing no further questions at this time. Thank you for participating in today’s conference. This does conclude the program. You may now disconnect.

謝謝。我目前沒有提出任何進一步的問題。感謝您參加今天的會議。這確實結束了該程式。您現在可以斷開連線。