Invitae Corp (NVTA) 2022 Q3 法說會逐字稿

Hello, everyone, and thank you for joining the Invitae's Third Quarter 2022 Financial Results Conference Call. My name is Darius, and I'll be the operator for today. (Operator Instructions)

大家好，感謝您參加 Invitae 的 2022 年第三季度財務業績電話會議。我的名字是大流士，我將擔任今天的接線員。 （操作員說明）

I now have the pleasure of handing you over to your host, Hoki Luk. Please go ahead, your line is now open.

我現在很高興將您交給您的主人 Hoki Luk。請繼續，您的線路現已開通。

Thank you, operator, and good afternoon, everyone. Thank you for joining us for our 2022 third quarter results call. Joining us today are President and CEO, Ken Knight; and our CFO, Roxi Wen.

謝謝接線員，大家下午好。感謝您加入我們的 2022 年第三季度業績電話會議。今天加入我們的是總裁兼首席執行官 Ken Knight；和我們的首席財務官 Roxi Wen。

Before we begin, I'd like to remind you the various remarks that we make on this call that are not historical, including those about our vision and business model, the company's strategic business realignment, future financial and operating results, expectations of future growth and reduction in burn rate and future products, services, our product pipeline and the timing constitute forward-looking statements within the meaning of the safe harbor provision of the Private Securities Litigation Reform Act. It is difficult to accurately predict demand for our services, and therefore, our actual results could differ materially from our stated outlook. Statements on future company performance assumes, among other things, so we don't conclude any additional business acquisitions, investments, restructuring or legal settlements. We refer you to our most recent 10-Q, in particular to the section titled Risk Factors for additional information on factors that could cause actual results to differ materially from our current expectations. These forward-looking statements speak only as of the date hereof.

在開始之前，我想提醒您我們在本次電話會議上所做的各種非歷史性言論，包括關於我們的願景和商業模式、公司的戰略業務重組、未來財務和經營成果、對未來增長的預期燃燒率和未來產品、服務、我們的產品管道和時間安排的降低構成《私人證券訴訟改革法案》安全港條款含義內的前瞻性陳述。很難準確預測對我們服務的需求，因此，我們的實際結果可能與我們陳述的前景存在重大差異。除其他事項外，關於未來公司業績的陳述假設，因此我們不會結束任何額外的業務收購、投資、重組或法律和解。我們向您推薦我們最近的 10-Q，特別是標題為“風險因素”的部分，以獲取有關可能導致實際結果與我們當前預期產生重大差異的因素的更多信息。這些前瞻性陳述僅在本文發布之日發表。

As you listen to today's conference call, we encourage you to have our press release available, which includes financial results as well as key growth metrics and commentary on the quarter. To supplement our consolidated financial statements prepared in accordance with generally accepted accounting principles in the United States or GAAP, we monitor and consider several non-GAAP measures. We encourage you to review our GAAP to non-GAAP reconciliations, which are available in the press release and in the appendix of the earnings slide deck, both of which you can access by visiting the Investors section of the company's website at ir.invitae.com.

在您收聽今天的電話會議時，我們鼓勵您提供我們的新聞稿，其中包括財務業績以及關鍵增長指標和本季度的評論。為了補充我們根據美國公認會計原則或 GAAP 編制的合併財務報表，我們監控並考慮了幾項非 GAAP 措施。我們鼓勵您查看我們的 GAAP 與非 GAAP 對賬，這些對賬可在新聞稿和收益幻燈片的附錄中找到，您可以通過訪問公司網站 ir.invitae 的投資者部分來訪問這兩者。 com。

Today, Ken and Roxi will discuss Q3 highlights, the continued execution of our realignment plan, updates within our portfolio, financials and key metrics of the third quarter, including our guidance and concluding the call with Q&A.

今天，Ken 和 Roxi 將討論第三季度的亮點、我們重組計劃的持續執行、我們投資組合的更新、財務和第三季度的關鍵指標，包括我們的指導和結束電話問答。

With that, I'll turn the call over to Ken.

有了這個，我會把電話轉給肯。

Thank you, Hoki, and thank you all for joining us today.

謝謝你，Hoki，謝謝大家今天加入我們。

Let me start with an overview of our third quarter performance, which shows solid operational execution against our realignment plan. We're proud of our team's ability to continue to deliver and appreciate their passion for our patients, our mission and our future. We're working hard and are encouraged by the financial and operational results of this quarter.

讓我先概述一下我們第三季度的業績，這顯示了我們的重組計劃的穩健運營執行。我們為我們的團隊能夠繼續傳遞和欣賞他們對我們的患者、我們的使命和我們的未來的熱情而感到自豪。我們正在努力工作，並對本季度的財務和運營結果感到鼓舞。

Revenue for the quarter was $133.5 million, growing almost 17% year-over-year. This was paired with further improvement in our gross margin with non-GAAP gross margin of 45.9% in the quarter compared to 35.6% in Q3 2021 and 40.1% in Q2 2022. We are well on track to achieve our full year non-GAAP gross margin forecast of 42% to 43%. Additionally, our efforts to reshape our cost profile has good momentum and is reflected in the reduction of our non-GAAP operating expenses to roughly 112% of revenue compared to 176% of revenues in Q3 2021 and 146% of revenues in Q2 2022. This work helped us to reduce our cash burn to $108 million in the quarter if we exclude onetime nonrecurring items compared to $169 million cash burn in Q1 2022. Roxi will provide an update later on how we see cash burn for the full year 2022. The reduction in cash burn to $108 million represents an annualized run rate reduction of approximately $245 million from Q1 and reinforces that we are on track to deliver the $326 million in cash burn reduction fully realized in 2023.

本季度收入為 1.335 億美元，同比增長近 17%。這與我們的毛利率進一步提高相結合，本季度非 GAAP 毛利率為 45.9%，而 2021 年第三季度為 35.6%，2022 年第二季度為 40.1%。我們有望實現全年非 GAAP 毛利率利潤率預測為 42% 至 43%。此外，我們重塑成本狀況的努力勢頭良好，體現在我們的非公認會計原則運營費用減少至收入的約 112%，而 2021 年第三季度為收入的 176%，2022 年第二季度為收入的 146%。這與 2022 年第一季度的 1.69 億美元現金消耗相比，如果我們排除一次性非經常性項目，我們的工作幫助我們在本季度將現金消耗減少到 1.08 億美元。Roxi 將在稍後提供我們如何看待 2022 年全年現金消耗的更新。減少現金消耗減少到 1.08 億美元，這意味著比第一季度的年化運行率減少了約 2.45 億美元，並強化了我們有望在 2023 年完全實現 3.26 億美元的現金消耗減少。

We have made the tough, but necessary workforce decision with notifications and reductions pretty much completed as planned. We've also made headway in consolidating our office and lab footprint, including steps to reduce underutilized office space. Regarding the consolidation of our geographic footprint, we have exited all impacted international territories prior to the end of September. In Q3, our ex U.S. business positively contributed to our improvement in non-GAAP gross margin. Finally, our portfolio optimization work has begun, and we have taken steps to consolidate our offering, including exiting our pre-implantation products for IVF and exiting other underperforming products and accounts. We continue to pursue divestiture or wind down of our distributed kits business, but not much more to report on that at this point. So in summary, we are on track to deliver the $326 million of cash burn reduction.

我們已經做出了艱難但必要的勞動力決定，通知和裁員幾乎按計劃完成。我們還在鞏固我們的辦公室和實驗室足跡方面取得了進展，包括採取措施減少未充分利用的辦公空間。關於鞏固我們的地理足跡，我們已在 9 月底之前退出了所有受影響的國際領土。在第三季度，我們的前美國業務為我們的非公認會計準則毛利率的提高做出了積極貢獻。最後，我們的投資組合優化工作已經開始，我們已採取措施整合我們的產品，包括退出我們的 IVF 植入前產品以及退出其他表現不佳的產品和賬戶。我們繼續尋求剝離或關閉我們的分佈式套件業務，但目前沒有更多關於這一點的報告。因此，總而言之，我們有望實現 3.26 億美元的現金消耗減少。

Now turning to core product areas. In hereditary cancer, the Invitae brand is trusted and valued. We generated an enormous amount of compelling data, and we've used that data to drive changes in guidelines and coverage policies, resulting in broader clinical adoption and more consistent reimbursement. Our most recent contribution includes an Invitae publication in JAMA, underscoring the American Society of Breast Surgeons guidelines, recommending that all breast cancer patients receive genetic testing. We also recently highlighted NCCN's decision to expand guidelines in CRC, advocating for universal germline testing for all colorectal cancer patients past and present. Hereditary cancer testing is still underpenetrated with some estimates as low as 10% to 20% of potential patients being tested.

現在轉向核心產品領域。在遺傳性癌症中，Invitae 品牌是值得信賴和重視的。我們生成了大量令人信服的數據，並使用這些數據來推動指南和覆蓋政策的變化，從而實現更廣泛的臨床採用和更一致的報銷。我們最近的貢獻包括在 JAMA 上發表的一份 Invitae 出版物，強調了美國乳腺外科醫生協會的指導方針，建議所有乳腺癌患者接受基因檢測。我們最近還強調了 NCCN 決定擴大 CRC 指南，提倡對過去和現在的所有結直腸癌患者進行通用生殖系檢測。遺傳性癌症檢測仍然沒有得到充分滲透，據估計只有 10% 到 20% 的潛在患者正在接受檢測。

In addition to expanding adoption, we have additional initiatives underway to bring product enhancements and improved workflows for more access and ease of use. We intend to keep the momentum going with the genetic council or community and are expanding our call points to nongenetic experts with a focus on workflows, education and decision support and pursue the very best outcomes for patients. Our hereditary cancer offering is our highest revenue business with a margin profile well above our corporate average.

除了擴大採用範圍外，我們還採取了其他舉措來增強產品和改進工作流程，以實現更多訪問和易用性。我們打算與遺傳委員會或社區保持這種勢頭，並將我們的呼叫點擴大到非遺傳專家，重點關注工作流程、教育和決策支持，並為患者爭取最好的結果。我們的遺傳性癌症產品是我們收入最高的業務，利潤率遠高於公司平均水平。

And our goal is to leverage this to extend offerings into the somatic space. The most recent addition to our somatic offering is our minimal residual disease product. We call it personalized cancer monitoring, or PCM, which is powered by our proprietary AMP technology. As many of you are aware, getting somatic testing incorporated into patient care is a massive opportunity. There are over 18 million cancer survivors in the U.S., and it's estimated that there are nearly 2 million new cases diagnosed each year. The total addressable market for MRD is $20 billion to $30 billion and is still in the early stages.

我們的目標是利用這一點將產品擴展到軀體空間。我們體細胞產品的最新成員是我們的最小殘留疾病產品。我們稱之為個性化癌症監測或 PCM，它由我們專有的 AMP 技術提供支持。你們中的許多人都知道，將體細胞測試納入患者護理是一個巨大的機會。美國有超過 1800 萬癌症倖存者，據估計每年診斷出近 200 萬新病例。 MRD 的總潛在市場為 200 億至 300 億美元，仍處於早期階段。

Widespread clinical use is still on the horizon, and we are actively working through the steps necessary to further facilitate the adoption of our PCM, engaging with clinicians, key opinion leaders and payers. Our goal is to continue to demonstrate the utility of PCM to combine it with our other oncology insights and to be positioned to enable cancer-treating physicians to advance precision oncology in an effort to move cancer into a chronic disease. PCM will provide the speed and accuracy to detect cancer sooner, thus reducing the downstream cost of care and improving patient outcomes. While we're working through reimbursement options in clinical trial results, we are supporting a growing number of top biopharma companies and academic medical centers who are partnering with us via fee-for-service arrangement to conduct research and generate revenue.

廣泛的臨床應用仍在進行中，我們正在積極採取必要的步驟，以進一步促進我們 PCM 的採用，與臨床醫生、主要意見領袖和付款人進行接觸。我們的目標是繼續展示 PCM 的實用性，將其與我們的其他腫瘤學見解相結合，並定位於使癌症治療醫生能夠推進精準腫瘤學，以將癌症轉變為慢性疾病。 PCM 將提供更快檢測癌症的速度和準確性，從而降低下游護理成本並改善患者預後。雖然我們正在通過臨床試驗結果的報銷選項進行工作，但我們正在支持越來越多的頂級生物製藥公司和學術醫療中心，他們通過按服務收費安排與我們合作進行研究並產生收入。

Moving on to women's health. Recent guideline expansion recommending screening for all pregnancies, including average risk, has created a meaningful tailwind to us and to this segment with a TAM of over $2 billion. As part of our operational shift, we've exited channels with lower quality revenue as well as implemented better reimbursement practices internationally. In the U.S., changes in our billing policy, improve calls performance and better discipline in our contracting have eliminated several underperforming aspects of this business. These factors together have taken our women's health non-GAAP gross margins from deeply negative to positive, and we expect continued improvement into next year. We're sharpening our product positioning, which includes new core and expanded panels, and we are also tapping into additional women's health channels, including OB/GYNs and breast surgeons to expand hereditary cancer testing.

繼續關注女性健康。最近的指南擴展建議篩查所有懷孕，包括平均風險，為我們和這個擁有超過 20 億美元 TAM 的細分市場創造了有意義的順風。作為我們運營轉變的一部分，我們已經退出了收入質量較低的渠道，並在國際上實施了更好的報銷做法。在美國，我們計費政策的變化、呼叫性能的提高和合同合同紀律的改善已經消除了該業務的幾個表現不佳的方面。這些因素共同使我們的女性健康非公認會計準則毛利率從負數變為正數，我們預計明年將繼續改善。我們正在加強我們的產品定位，其中包括新的核心和擴展面板，我們還在利用其他女性健康渠道，包括 OB/GYN 和乳房外科醫生，以擴大遺傳性癌症檢測。

On the rare disease and data side of our business, we are seeing growth opportunities bridging our testing and data collection. Our testing business gives us access to multiple disease population and hundreds of clinician relationships. We now have an emerging capability to combine genomic and phenotypic data, including real-world evidence and are seeing an enthusiastic response to this capability among patients, advocacy groups, researchers and biopharma partners in the rare disease area. We are excited about the growth of our recent partnerships with Praxis. We used our platform as natural history data to support their IND application for the treatment of pediatric epilepsy and with AstraZeneca, who is using our platform for real-world data in the research of a rare bile duct cancer.

在我們業務的罕見疾病和數據方面，我們看到了連接我們測試和數據收集的增長機會。我們的檢測業務使我們能夠接觸到多種疾病人群和數百名臨床醫生關係。我們現在擁有一種新興的能力，可以結合基因組和表型數據，包括真實世界的證據，並且在罕見病領域的患者、倡導團體、研究人員和生物製藥合作夥伴中看到了對這種能力的熱烈反應。我們對最近與 Praxis 合作夥伴關係的發展感到興奮。我們使用我們的平台作為自然歷史數據來支持他們在治療小兒癲癇方面的 IND 申請，並與阿斯利康合作，後者正在使用我們的平台獲取真實世界數據來研究一種罕見的膽管癌。

While currently a small part of our total revenue, our data segment is a high-growth, high-margin and scalable business, and there are more opportunities in our pipeline. By the way, recent findings in JAMA demonstrate that a positive epilepsy genetic diagnosis leads to clinical management changes in approximately half of patients and the changes implemented by clinicians based on genetic testing, improve health outcomes and as many as 3/4 of patients. This will help adoption and reimbursement of our epilepsy genetic testing product.

雖然目前只占我們總收入的一小部分，但我們的數據部門是一項高增長、高利潤和可擴展的業務，我們的管道中有更多機會。順便說一句，JAMA 最近的研究結果表明，癲癇基因診斷陽性導致大約一半患者的臨床管理髮生變化，臨床醫生根據基因檢測實施的改變，改善了多達 3/4 患者的健康結果。這將有助於我們的癲癇基因檢測產品的採用和報銷。

With that, I'll turn it over to Roxi for financial highlights of our most recent quarter.

有了這個，我將把它交給 Roxi 來了解我們最近一個季度的財務亮點。

Thank you, Ken.

謝謝你，肯。

In the third quarter of 2022, we generated approximately $134 million of revenue, and the breakdown was as follows: approximately $79 million from oncology, including germline testing, therapy selection and PCM services offered to the pharmaceutical partners, representing a 12% growth over the prior year; approximately $25 million from our women's hub offerings, including NIPS, carrier and other reproductive tests, a 19% growth over the prior year; approximately $17 million from RareDx and other testing products, 17% growth over prior year. Data and patient network revenue grew 48% over last year. This includes data management, data as a service and the partnership projects supported by the Citizen patient network.

2022 年第三季度，我們創造了約 1.34 億美元的收入，細分如下：腫瘤學約 7900 萬美元，包括向製藥合作夥伴提供的種系檢測、治療選擇和 PCM 服務，比上年增長 12%去年;大約 2500 萬美元來自我們的女性中心產品，包括 NIPS、載體和其他生殖測試，比上一年增長 19%；來自 RareDx 和其他測試產品的約 1700 萬美元，比去年增長 17%。數據和患者網絡收入比去年增長了 48%。這包括數據管理、數據即服務以及由 Citizen 患者網絡支持的合作項目。

Non-GAAP gross margin was 45.9%, which is an improvement of over 1,000 basis points from the prior year and 580 basis points from prior quarter. Non-GAAP operating expenses was $150 million or 112% of revenue compared to $200 million or 146% of revenue in the second quarter of 2022 and 176% of revenue in the third quarter of the prior year. As a result of our realignment plan, we also incurred more than $125 million of restructuring and other onetime expenses, including employee separation and benefits, loss on asset disposals and other costs. These items were excluded from our Q3 non-GAAP operating expenses in today's presentation.

非美國通用會計準則毛利率為 45.9%，比上年提高 1,000 多個基點，比上一季度提高 580 個基點。非美國通用會計準則運營費用為 1.5 億美元，佔收入的 112%，而 2022 年第二季度為 2 億美元，佔收入的 146%，上年第三季度為收入的 176%。由於我們的重組計劃，我們還產生了超過 1.25 億美元的重組和其他一次性費用，包括員工離職和福利、資產處置損失和其他成本。在今天的演示中，這些項目不包括在我們的第三季度非公認會計原則運營費用中。

We stated on our first quarter call that we plan to hold our operating expenses at a stable level. And on our July call, we further committed to reduce that figure by a significant amount going forward. Our actions, including reduction in headcount, lab and office space, third-party services as well as exiting certain businesses and geographies resulted in operating expenses reduction of nearly $50 million from the prior quarter. We expect additional reductions to our quarterly run rate over the next 2 to 3 quarters as our broad cost reduction efforts take effect.

我們在第一季度電話會議上表示，我們計劃將運營費用保持在穩定水平。在我們 7 月的電話會議上，我們進一步承諾在未來大幅減少這一數字。我們的行動，包括減少員工人數、實驗室和辦公空間、第三方服務以及退出某些業務和地區，導致運營費用比上一季度減少近 5000 萬美元。隨著我們廣泛的成本削減努力生效，我們預計未來 2 到 3 個季度的季度運行率將進一步降低。

Moving on to cash performance. Cash, cash equivalents, restricted cash and marketable securities totaled $596 million at September 30, 2022, compared to $737 million at June 30, 2022. Our cash position went down by about $141 million compared to the end of the second quarter. Excluding the inflow of approximately $2 million from our ATM facility, our total cash burn was $151 million. Adjusting for onetime items, including approximately $29 million related to the realignment program and $14 million related to compensation items for past M&A transactions, the cash burn for our ongoing business would be $108 million in Q3, a meaningful reduction from the run rate at the beginning of 2022. While we're nimble with our ATM financing options, we do not intend to use it to solve our debt maturities. Instead, we continue to have conversations with long-term partners who have a shared vision of our company and a desire to find a constructive solution to our balance sheet. As of now, we have close to $600 million cash, and our cash burn trajectory is heading in the right direction, aided by the efforts we put into place over the past year and accelerated by our strategic realignment.

繼續現金業績。截至 2022 年 9 月 30 日，現金、現金等價物、受限現金和有價證券總計 5.96 億美元，而 2022 年 6 月 30 日為 7.37 億美元。與第二季度末相比，我們的現金頭寸減少了約 1.41 億美元。不包括從我們的 ATM 設施流入的大約 200 萬美元，我們的總現金消耗為 1.51 億美元。調整一次性項目，包括與重組計劃相關的約 2900 萬美元和與過去併購交易的補償項目相關的 1400 萬美元，我們正在進行的業務的現金消耗將在第三季度達到 1.08 億美元，比一開始的運行率顯著降低2022 年。雖然我們對 ATM 融資選擇很靈活，但我們不打算用它來解決我們的債務到期問題。相反，我們繼續與對我們公司有共同願景並希望為我們的資產負債表找到建設性解決方案的長期合作夥伴進行對話。截至目前，我們擁有近 6 億美元的現金，我們的現金消耗軌跡正朝著正確的方向前進，這得益於我們在過去一年中所做的努力以及我們的戰略調整加速。

Stepping to the business metrics that are intended to offer more transparency and a more consistent balanced perspective on our performance and the portfolio growth, our active accounts continue to fuel top line growth despite active partner being relatively stable in Q3 due to our geographic consolidation and focus on higher quality revenue. The impact of these efforts will continue to be a slight headwind to this metric. However, the number of patients we served and ones who are available to share the data continue to expand, each grew roughly 48% over prior year and 10% sequentially. Our new product vitality was down slightly from previous quarters. As a reminder, this metric represents a revenue contribution by new products over the trailing 3 years. As previously communicated, we saw a pullback in our numbers resulting from the slowdown in new product launches in 2020 and part of 2021. Revenue per patient measured by total company revenue divided by the number of ordering patients for the period has continued to increase as we have focused our broader efforts on achieving higher quality revenue.

我們的業務指標旨在為我們的業績和投資組合增長提供更高的透明度和更一致的平衡視角，儘管由於我們的地域整合和專注，活躍的合作夥伴在第三季度相對穩定，但我們的活躍賬戶繼續推動收入增長更高質量的收入。這些努力的影響將繼續對該指標構成輕微的阻力。然而，我們服務的患者數量和可共享數據的患者數量繼續增加，每個都比去年增長約 48%，環比增長 10%。我們的新產品活力比前幾個季度略有下降。提醒一下，該指標代表新產品在過去 3 年的收入貢獻。如前所述，由於 2020 年和 2021 年部分時間新產品發布放緩，我們的人數有所回落。按公司總收入除以該期間訂購患者人數衡量的每位患者收入持續增加，因為我們已將我們更廣泛的努力集中在實現更高質量的收入上。

Moving to operational excellence. We're seeing continued quarter-over-quarter improvement in all categories. Cash burn had a number of onetime items in this quarter. Cash burn as a percent of revenue would have been 81%, excluding the onetime items.

邁向卓越運營。我們看到所有類別的季度環比都在持續改善。現金消耗在本季度有許多一次性項目。現金消耗佔收入的百分比為 81%，不包括一次性項目。

Moving to our financial guidance. We're reaffirming our 2022 revenue growth and non-GAAP gross margin targets. We expect full year 2022 revenue growth of low-double digits over the prior year and our non-GAAP gross margin to be between 42% and 43%. For the fourth quarter, as previously communicated, we project to have less revenue than the third quarter based on the fact that it's the first full quarter of operations since our realignment started in mid-July. There will also be some revenue impact depending on our final decision and the timing of that decision regarding our distributed chip business. Taking these factors and our current trajectory into consideration, we're maintaining our full year revenue guidance of low-double-digit growth.

轉到我們的財務指導。我們重申我們的 2022 年收入增長和非公認會計準則毛利率目標。我們預計 2022 年全年收入將比上年低兩位數增長，我們的非美國通用會計準則毛利率將在 42% 至 43% 之間。如前所述，對於第四季度，我們預計收入將低於第三季度，因為這是自 7 月中旬開始調整以來的第一個完整運營季度。取決於我們的最終決定以及關於我們分佈式芯片業務的決定時間，也會對收入產生一些影響。考慮到這些因素和我們目前的發展軌跡，我們將維持低兩位數增長的全年收入指導。

Looking at our cash burn. We now expect full year 2022 cash burn to be between 585 and $625 million, improvement from our previous guidance of $600 million to $650 million. Note that the cash burn guidance includes up to $75 million related to realignment activities, and this amount has remained the same as our previous guidance. We're encouraged by our progress to date and are confident in our team's ability to deliver.

看看我們的現金消耗。我們現在預計 2022 年全年的現金消耗將在 585 美元至 6.25 億美元之間，高於我們之前的 6 億美元至 6.5 億美元的指導。請注意，現金消耗指導包括高達 7500 萬美元與重組活動相關的費用，這一數額與我們之前的指導保持一致。我們對迄今為止取得的進展感到鼓舞，並對我們團隊的交付能力充滿信心。

Back to you, Ken.

回到你身邊，肯。

Thank you, Roxi. With that, we'll now turn the call over to the operator for Q&A.

謝謝你，羅西。有了這個，我們現在將把電話轉給接線員進行問答。

(Operator Instructions) The first question comes from Tejas Savant from Morgan Stanley.

（操作員說明）第一個問題來自摩根士丹利的 Tejas Savant。

This is Gaby Gabel on for Tejas Savant. So I was just wondering if the recent granting of preliminary injunction preventing California from enforcing a requirement of only labs contracting with them would be allowed to perform trisomy screening for California residents? And if that would affect your NIPT volumes going forward and how we should think about that impact of the NIPT providers?

這是 Tejas Savant 的 Gaby Gabel。所以我只是想知道，如果最近授予的初步禁令阻止加利福尼亞執行僅與他們簽約的實驗室的要求，是否會被允許對加利福尼亞居民進行三體篩查？如果這會影響您未來的 NIPT 數量，我們應該如何考慮 NIPT 提供者的影響？

Yes. This is Ken. That's a great question. We obviously were not supportive of the direction that CDPH was taking, and so it continues to allow us to operate in the state of California with our NIPS product, which we're excited about. And so as we see the broadening guidelines and expansion of guidelines and making the utility of NIPS more accessible to pregnant women, we see it as nothing but upside for us.

是的。這是肯。這是一個很好的問題。我們顯然不支持 CDPH 所採取的方向，因此它繼續允許我們使用我們的 NIPS 產品在加利福尼亞州開展業務，對此我們感到很興奮。因此，當我們看到不斷擴大的指南和指南的擴展，以及讓孕婦更容易使用 NIPS 的效用時，我們認為這對我們來說只是好處。

That was very helpful. And then just in terms of your hereditary cancer business, what are you seeing in terms of a shift towards expanded carrier screen panels? And what do you think are the challenges for broader adoption?

這很有幫助。然後就您的遺傳性癌症業務而言，您對向擴展載體屏幕面板的轉變有何看法？您認為更廣泛採用的挑戰是什麼？

Was the question of expanded carrier screening?

是擴大攜帶者篩查的問題嗎？

Expanded carrier screen panels.

擴展的載體屏幕面板。

Yes. So we have some work underway actually bringing out an expanded carrier screening product here pretty soon. There's a specific utility of expanded carrier screening. It's obviously used for more complicated type of diagnoses. And so we see there's a place for expanded carrier. But we don't expect that every one of our customers that are ordering carrier screening today is going to pivot to the expanded products. So we'll have the option for our customers in the future.

是的。因此，我們正在進行一些工作，實際上很快就會在這裡推出擴展的載體篩查產品。擴展載體篩查有一個特定的用途。它顯然用於更複雜的診斷類型。所以我們看到有一個擴大運營商的地方。但我們並不期望今天訂購承運人篩查的每一位客戶都會轉向擴展產品。因此，我們將在未來為客戶提供選擇。

The next question comes from Matthew Sykes from Goldman Sachs.

下一個問題來自高盛的 Matthew Sykes。

This is [Ivy] on for Matt. Could you just talk through the new product vitality metric, which is a little lower on a sequential basis? I know last quarter, you talked about new products coming on in second half of this year. So any update on those would be helpful.

這是馬特的[常春藤]。您能否談談新產品活力指標，該指標在連續基礎上略低一些？我知道上個季度，你談到了今年下半年推出的新產品。因此，任何有關這些的更新都會有所幫助。

Roxi, why don't you take that one?

Roxi，你為什麼不拿那個？

Sure. Just to -- great question, thank you. Remind the destination is revenue contribution from our new products or either acquired or internally developed over the last 3 years. So as you indicated, the launches and the schedule and timing of launch does have an implication on this metric. We did have some product -- new product launches at the first half of this year and expect some of those revenues will come in. But we are not providing guidance for these metrics, but we do recognize that the 2020 and 2021, part of 2021 slowdown is having an impact on this metric.

當然。只是——很好的問題，謝謝。提醒目的地是我們的新產品或過去 3 年收購或內部開發的收入貢獻。因此，正如您所指出的，發布以及發布的時間表和時間確實對這個指標有影響。我們確實有一些產品——今年上半年推出了新產品，預計其中一些收入會進來。但我們沒有為這些指標提供指導，但我們確實認識到 2020 年和 2021 年是 2021 年的一部分放緩正在對該指標產生影響。

Great. And then could you talk to pricing dynamics you're seeing in oncology and women's health and what impact that might have on margins as we move into '23? I know you mentioned more data in hereditary cancer, which is driving reimbursements, but additional color would be helpful.

偉大的。然後你能談談你在腫瘤學和女性健康方面看到的定價動態，以及隨著我們進入 23 世紀，這可能對利潤率產生什麼影響？我知道你提到了更多關於遺傳性癌症的數據，這推動了報銷，但額外的顏色會有所幫助。

Yes, sure. For our women's health products, we've been seeing great improvement in our ability to give reimbursement. The expanded guidelines are helping immensely. Average risk is now covered pretty much with the most major -- almost all major players in the U.S. And so that's having a tailwind in our average payment per test for our NIPS products. We made some decisions about pricing ex U.S. in international marketplace. And as I said in my preamble, the benefit of that is we're seeing our ex U.S. business providing positive contribution to our gross margin expansion initiatives. So we're seeing that working as well. So I'd say from a pricing standpoint, where pricing changes needed to be done, we've done those, and we've seen great benefit from it.

是的，當然。對於我們的女性保健產品，我們已經看到我們的報銷能力有了很大的提高。擴展的指導方針有很大的幫助。平均風險現在幾乎涵蓋了最主要的——幾乎所有美國的主要參與者。因此，這對我們的 NIPS 產品每次測試的平均支付產生了順風。我們做出了一些關於在國際市場上以美國以外的價格定價的決定。正如我在序言中所說，這樣做的好處是我們看到我們的前美國業務為我們的毛利率擴張計劃做出了積極貢獻。因此，我們也看到了這一點。所以我想說的是，從定價的角度來看，在需要進行定價更改的地方，我們已經完成了這些，並且從中受益匪淺。

For hereditary cancer, it's been pretty solid. I mean I think the -- as I said, our gross margin performance of our hereditary cancer product is well above our corporate average, and it's staying pretty consistent. And so we don't see necessarily downward pressure on pricing any more than what we are doing in the marketplace. We continue to be the provider who is trying to drive more affordable, accessible access to genetic testing. So we still believe in that part of our journey. But the pricing in the marketplace is pretty solid. There were some concerns about PAMA, making some changes, but that's obviously been held back for now. And so overall, we see the quality of revenue for hereditary cancer is growing based upon our reimbursement and internal policies and how we're going to market.

對於遺傳性癌症，它非常可靠。我的意思是我認為 - 正如我所說，我們的遺傳性癌症產品的毛利率表現遠高於我們的公司平均水平，並且保持相當一致。因此，與我們在市場上所做的相比，我們認為定價方面的下行壓力並不一定更大。我們繼續作為提供者，努力推動更實惠、更容易獲得基因檢測。所以我們仍然相信我們旅程的那一部分。但是市場上的定價相當穩定。對 PAMA 有一些擔憂，做出了一些改變，但這顯然暫時被擱置了。總的來說，我們看到遺傳性癌症的收入質量正在增長，這取決於我們的報銷和內部政策以及我們將如何進入市場。

The next question is from [Marta Nazarewicz] from JPMorgan Chase.

下一個問題來自摩根大通的 [Marta Nazarewicz]。

This is [Marta] on for Julia. So as it relates to your current mix between oncology, women's health and others, how do you see those mix is evolving over the next year, given the restructuring? And how do you see that mix settling beyond 2023? Essentially, what are some qualitative factors impacting that mix?

這是朱莉婭的[瑪塔]。因此，由於它與您目前在腫瘤學、女性健康和其他方面的組合有關，鑑於重組，您如何看待這些組合在明年的演變？您如何看待這種組合在 2023 年之後穩定下來？本質上，影響這種組合的一些定性因素是什麼？

So I'd simply put, as hereditary cancer product line is our highest revenue product and it will continue to be our highest revenue product into 2023. And so I wouldn't say there's a material shift in mix that's going to be occurring. As we are adjusting our go-to-market for our women's health, we are getting a higher quality of revenue for each of the tests that we're running. And so that's going to provide some lift in our gross margin, but I'm not expecting it to shift our mix significantly into 2023. So I think our mix is going to continue to be more weighted towards hereditary cancer into 2023 and beyond.

所以我簡單地說，因為遺傳性癌症產品線是我們收入最高的產品，並且到 2023 年它將繼續是我們收入最高的產品。所以我不會說組合會發生重大轉變。隨著我們為女性健康調整我們的市場，我們正在為我們運行的每項測試獲得更高質量的收入。因此，這將提高我們的毛利率，但我預計它不會顯著改變我們的組合到 2023 年。所以我認為到 2023 年及以後，我們的組合將繼續更加重視遺傳性癌症。

Got it. And then the second question was related to the MRD product that you've mentioned. Could you just give a little bit more detail about that? And how quickly do you think it could drive penetration of that product? And what are some of the competitive advantages over the existing products in the market?

知道了。然後第二個問題與您提到的 MRD 產品有關。你能提供更多細節嗎？您認為它能夠以多快的速度推動該產品的滲透？與市場上現有產品相比，有哪些競爭優勢？

Yes, sure. I mean I'll start with how we see the product itself. Again, you might recall, we have a tumor-specific product. And so there's products that are out there that are tumor agnostic. We have a tumor-specific product, and we provide a panel specific to the patient and the tumor that the patient has, which, we believe, is a superior product. That's number one. Our early data and analysis that we've seen is that our sensitivity and specificity are going to be top of the market in terms of how the product will perform.

是的，當然。我的意思是，我將從我們如何看待產品本身開始。同樣，您可能還記得，我們有一種腫瘤特異性產品。因此，有些產品與腫瘤無關。我們有一種腫瘤特異性產品，我們為患者和患者所患的腫瘤提供了一個特定的面板，我們相信這是一個優質的產品。那是第一名。我們看到的早期數據和分析表明，就產品的性能而言，我們的敏感性和特異性將成為市場的佼佼者。

And so we've done -- we're now in a period of time where we've got analytic validity and now we're going in the process of getting clinical validity of our product. And so we've got several studies that are out there that are -- we expect they're going to continue to show the clinical validity of our product. And as we navigate through that, then we'll be moving to kind of getting confidence in the utility of our product and ultimately utilization and reimbursement. So the journey is pretty well mapped out. We know how to do this. We're just in the process of getting that done. And in the meantime, we're utilizing our fee-for-service arrangements with biopharma or academic medical centers. And we're getting good interest in our product and our PCM product. And we expect that's going to be kind of a bridging revenue opportunity for us until we get all the way to commercial utilization and commercial reimbursement.

所以我們已經完成了——我們現在處於一個獲得分析有效性的時期，現在我們正處於獲得產品臨床有效性的過程中。因此，我們已經進行了幾項研究——我們預計它們將繼續顯示我們產品的臨床有效性。當我們通過這個導航時，我們將開始對我們產品的實用性以及最終的使用和報銷產生信心。所以行程安排得很好。我們知道如何做到這一點。我們只是在完成這件事的過程中。與此同時，我們正在利用我們與生物製藥或學術醫療中心的按服務收費安排。我們對我們的產品和 PCM 產品產生了濃厚的興趣。我們預計這對我們來說將是一個過渡性的收入機會，直到我們一路實現商業利用和商業報銷。

We're pretty excited about it. So I hope, as I was answering the question, I want to make sure you understand. We are very excited about our MRD product. And the space is, as I said, in the opening $20 billion to $30 billion of TAM, and it's still underutilized. And so it's early, and we're excited to be competing in that space in the very near future.

我們對此感到非常興奮。所以我希望，當我回答這個問題時，我想確保你理解。我們對我們的 MRD 產品感到非常興奮。正如我所說，這個空間在 200 億至 300 億美元的 TAM 中，但仍未得到充分利用。所以現在還為時過早，我們很高興能在不久的將來在這個領域競爭。

(Operator Instructions) It appears we have no questions registered at this moment. I'm going to hand back to the management team.

（操作員說明）目前我們似乎沒有登記任何問題。我將交還給管理團隊。

Well, thank you, operator, and thanks, everybody, for joining us on the call today. We remain very positive about the opportunities for Invitae, and we're extremely confident in our team's ability to execute on our plans. So we appreciate your continued support, and thank you all for joining us on the call.

好吧，謝謝您，接線員，謝謝大家今天加入我們的電話會議。我們對 Invitae 的機會仍然非常樂觀，我們對團隊執行計劃的能力非常有信心。因此，我們感謝您一直以來的支持，並感謝大家加入我們的電話會議。

This concludes today's call. Thank you for joining. You may now disconnect your lines.

今天的電話會議到此結束。感謝您的加入。您現在可以斷開線路。