GeneDx Holdings Corp (WGS) 2024 Q3 法說會逐字稿

Thank you for standing by and welcome to the GeneDx third quarter 2024 earnings conference call.

感謝您的耐心等待並歡迎參加 GeneDx 2024 年第三季財報電話會議。

(Operator Instructions) I would now like to turn the call over to Sabrina Dunbar, Investor Relations.

（操作員說明）我現在想將電話轉給投資者關係部門的 Sabrina Dunbar。

Please go ahead.

請繼續。

Thank you, Operator, and thank you to everyone for joining us today.

謝謝運營商，也謝謝大家今天加入我們。

On the call, we have Katherine Stueland, President and Chief Executive Officer; and Kevin Feeley, Chief Financial Officer.

總裁兼執行長凱瑟琳·斯圖蘭 (Katherine Stueland) 出席了電話會議。和財務長凱文·菲利。

Earlier today, GeneDx released financial results for the third quarter ended September 30, 2024.

今天早些時候，GeneDx 發布了截至 2024 年 9 月 30 日的第三季財務業績。

Before we begin, please take note of our cautionary statement.

在我們開始之前，請注意我們的警告聲明。

We may make forward-looking statements on today’s call, including about our business plans, guidance, and outlook.

我們可能會在今天的電話會議上發表前瞻性聲明，包括我們的業務計劃、指導和前景。

Forward-looking statements inherently involve risks and uncertainties and only reflect our view as of today, October 29, and we are under no obligation to update.

前瞻性陳述本質上涉及風險和不確定性，僅反映我們截至今天（10 月 29 日）的觀點，我們沒有義務進行更新。

When discussing our results, we refer to non-GAAP measures, which exclude certain items from reported results.

在討論我們的結果時，我們指的是非公認會計準則衡量標準，這些衡量標準從報告的結果中排除了某些項目。

Please refer to our third quarter 2024 earnings release and slides available at ir.genedx.com for definitions and reconciliations of non-GAAP measures and additional information regarding our results, including a discussion of factors that could cause actual results to materially differ from forward-looking statements.

請參閱我們在ir.genedx.com 上發布的2024 年第三季度收益報告和幻燈片，以了解非GAAP 指標的定義和調節以及有關我們結果的其他信息，包括對可能導致實際結果與前瞻性結果存在重大差異的因素的討論。

And with that, I will turn the call over to Katherine.

然後，我會將電話轉給凱瑟琳。

Thanks, Sabrina, and thank you all for joining us.

謝謝薩布麗娜，也謝謝大家加入我們。

The third quarter was an exceptionally strong quarter for GeneDx.

對 GeneDx 來說，第三季是個異常強勁的季度。

We delivered over $76 million in revenues, expanded gross margins to 64%, and achieved our tenth consecutive quarter of cash burn reduction.

我們實現了超過 7,600 萬美元的收入，將毛利率擴大到 64%，並實現了連續第十個季度現金消耗減少。

Our organizational focus and discipline continued to fuel our growth and we achieved profitability in the third quarter.

我們的組織重點和紀律繼續推動我們的成長，我們在第三季度實現了盈利。

This milestone is an important one in the industry.

這一里程碑在業界具有重要意義。

We've demonstrated that you can prioritize patient care and do it while running a successful business.

我們已經證明，您可以優先考慮患者護理，並在經營成功的企業的同時做到這一點。

And as we walk through the door of profitability, we're entering a new phase of growth for GeneDx, one in which we hold a sustainable and durable market-leading position in exome and genome testing and translate our leadership to serve all patients who can benefit from genomic insights.

當我們邁入獲利之門時，我們正在進入GeneDx 的一個新的成長階段，在這個階段，我們在外顯子組和基因組測試方面保持可持續和持久的市場領先地位，並將我們的領導地位轉化為服務所有可以的患者從基因組見解中受益。

On the back of a strong Q3, we're raising our revenue guidance for the full year 2024 to between $284 million to $290 million.

在第三季表現強勁的背景下，我們將 2024 年全年營收指引上調至 2.84 億美元至 2.9 億美元之間。

We're bullish on our ability to keep expanding our footprint to the pediatric outpatient setting and begin extending our reach into new clinical settings in the years to come.

我們看好我們有能力繼續將我們的足跡擴展到兒科門診環境，並在未來幾年開始將我們的業務擴展到新的臨床環境。

Our work is just getting started.

我們的工作才剛開始。

Today we enjoy 80% of the US exome market share.

如今，我們佔據了美國外顯子組市場 80% 的份額。

Historically, our dominance is anchored in volumes from expert genetics providers.

從歷史上看，我們的主導地位是建立在專家遺傳學提供者的數量上的。

But beginning in 2023, we shifted our commercial focus to pediatric neurologists who represented the next rung of clinicians primed for a more comprehensive approach to genetic testing.

但從 2023 年開始，我們將商業重點轉向兒科神經科醫生，他們代表了下一代臨床醫生，準備採用更全面的基因檢測方法。

While these pediatric neurologists have significantly expanded adoption and fuel growth over the last 12 months, there remains an ample multi-year growth opportunity ahead as we remain approximately 12% penetrated amongst the specialists.

雖然這些兒科神經科醫生在過去 12 個月中顯著擴大了採用率並推動了成長，但未來仍有充足的多年成長機會，因為我們在專家中的滲透率仍約為 12%。

As we look at the path in front of us, there are many untapped growth catalysts yet to be unlocked.

當我們審視眼前的道路時，還有許多尚未開發的成長催化劑有待釋放。

We see expanded clinical indications for exome and genome entry into the general pediatrician market and the development of additional patient access channels as opportunities to cultivate new arenas for our market leadership.

我們認為外顯子組和基因組進入普通兒科醫生市場的臨床適應症的擴大以及額外患者准入管道的開發是我們為市場領導地位培育新領域的機會。

We're proud to share that as of Q3, we've officially sequenced over 700,000 clinical exomes and genomes completing over 100,000 of those sequences in the last six months alone.

我們很自豪地與大家分享，截至第三季度，我們已正式對超過 700,000 個臨床外顯子組和基因組進行了測序，僅在過去六個月內就完成了超過 100,000 個序列。

This acceleration is a testament to growing utilization of our exome and genome testing while creating a flywheel effect for our business.

這種加速證明了我們的外顯子組和基因組測試的利用率不斷提高，同時為我們的業務創造了飛輪效應。

With every test we complete, we deepen our understanding of disease gene correlations to inform more definitive diagnoses for more patients.

隨著我們完成的每一次測試，我們加深了對疾病基因相關性的理解，為更多患者提供更明確的診斷。

We unlock improved operational efficiency and lower cost.

我們提高了營運效率並降低了成本。

And we further differentiate our products from those of our competitors.

我們進一步將我們的產品與競爭對手的產品區分開來。

This acceleration and volume also demonstrate our ability to scale our data engine.

這種加速和數量也證明了我們擴展數據引擎的能力。

And positions us to be a key strategic partner for biopharma.

並使我們成為生物製藥的重要策略夥伴。

We're leveraging our growing data asset to deliver value to biopharma companies, big and small, while supporting our own commercial initiative, as evidenced by our epilepsy partnership program, which improves access to testing for children with epilepsy while delivering valuable insights to biopharma looking to inform their drug development efforts with new targets and find patients to enroll in active clinical trials.

我們正在利用不斷增長的數據資產為大大小小的生物製藥公司提供價值，同時支持我們自己的商業計劃，我們的癲癇合作夥伴計劃就證明了這一點，該計劃改善了癲癇兒童的檢測機會，同時為生物製藥公司提供了寶貴的見解為他們的藥物開發工作提供新的靶標，並尋找患者參加活躍的臨床試驗。

In the NICU, we're seeing a steady increase in rapid whole genome volume quarter over quarter as we set the stage for a broader push in 2025.

在新生兒加護病房 (NICU) 中，我們看到全基因組數量逐季穩定成長，為 2025 年更廣泛的推動奠定了基礎。

We announced in Q2 that we've taken steps to solidify our position in this growing market with product improvements and a partnership with Epic Aura.

我們在第二季宣布，我們已採取措施，透過產品改進以及與 Epic Aura 的合作來鞏固我們在這個不斷增長的市場中的地位。

Recent product releases are already providing an uplift in this segment and we're proving that our product and technology approach is effective.

最近發布的產品已經為這一領域帶來了提升，我們正在證明我們的產品和技術方法是有效的。

Regarding Epic, we're well on our way to implementing our partnership which will seamlessly integrate GeneDx exome and genome testing into the workflows and many of the largest health systems across the country.

關於 Epic，我們正在順利實施我們的合作夥伴關係，該合作夥伴關係將把 GeneDx 外顯子組和基因組測試無縫整合到工作流程和全國許多最大的衛生系統中。

We expect to begin receiving orders through or in the first half of 2025 with revenue ramping in the second half of the year.

我們預計在 2025 年上半年或上半年開始接收訂單，下半年營收將大幅成長。

Our experience in the NICU has demonstrated time and again the power of a genetic diagnosis to change the course of a baby's life.

我們在新生兒加護病房的經驗一次又一次地證明了基因診斷改變嬰兒生命歷程的力量。

We also know there's an opportunity to intervene even earlier.

我們也知道有機會更早介入。

We believe in a world where every newborn genome can be sequenced at first.

我們相信每個新生兒基因組都可以先被定序的世界。

And we're confident GeneDx will lead this opportunity to revolutionize the traditional approach to newborn screening by adding genomic sequencing.

我們相信 GeneDx 將透過添加基因組定序來引領這一機會，徹底改變傳統的新生兒篩檢方法。

Today's traditional newborn screening protocol tests for about 60 conditions.

現今的傳統新生兒篩檢方案可測試約 60 種病症。

But with the addition of genomic sequencing, newborn screening can be enhanced to screen for more than 450 actionable conditions.

但透過增加基因組定序，可以增強新生兒篩檢，以篩檢 450 多種可行的條件。

For some of these families, actionability can be as simple as changing their baby's diet.

對其中一些家庭來說，可採取的行動就像改變嬰兒的飲食一樣簡單。

And for others, it can mean enrolling in a clinical trial or treating a condition with an FDA proof therapy.

對其他人來說，這可能意味著參加臨床試驗或使用 FDA 證明的療法來治療某種疾病。

We are approaching the genomic newborn screening opportunity with a never before seen scale.

我們正以前所未有的規模進行新生兒基因組篩檢。

In the short-time frame we've invested in the space, we've sequenced more than 15,000 newborns, which is more than any other lab in the United States.

在我們投資該空間的短時間內，我們已經對 15,000 多名新生兒進行了測序，這比美國任何其他實驗室都多。

We began work with the GUARDIAN study nearly two years ago and the findings of that research were published last week in the journal of the American Medical Association, a leading peer reviewed publication.

大約兩年前，我們開始進行 GUARDIAN 研究，該研究的結果上週發表在領先的同行評審出版物《美國醫學會》雜誌上。

An analysis of GUARDIAN participants found a nearly 4% positivity rate with genomic newborn screening.

對 GUARDIAN 參與者的分析發現，新生兒基因組篩檢的陽性率接近 4%。

Dramatically, 92% of newborns with true positive results would have been assumed healthy and sent home using today's traditional newborn screening.

引人注目的是，使用當今的傳統新生兒篩檢，92% 的真正呈陽性結果的新生兒會被認為是健康的並被送回家。

In the absence of proactive genomic screening for these conditions, we're subjecting families to a multi-year diagnostic odyssey and funneling a pipeline of sick kids directly into our healthcare system.

在缺乏這些疾病的主動基因組篩檢的情況下，我們正在對家庭進行多年的診斷冒險，並將患病兒童的管道直接輸送到我們的醫療保健系統中。

In the meantime, we have an incredible opportunity to serve an ever growing number of patients and their families who are symptomatic today with our industry leading exome and genome testing.

同時，我們有一個難以置信的機會，透過我們行業領先的外顯子組和基因組測試，為越來越多有症狀的患者及其家人提供服務。

Our focus and financial discipline combined with the proven clinical utility of our testing are setting us up for the next phase of sustainable growth.

我們的重點和財務紀律與經過驗證的測試臨床實用性相結合，為我們下一階段的可持續成長奠定了基礎。

And we're excited by the opportunities ahead.

我們對未來的機會感到興奮。

And with that, I'll turn it over to Kevin.

有了這個，我會把它交給凱文。

Thanks Katherine and good morning, everyone.

謝謝凱瑟琳，大家早安。

In the third quarter of 2024, our revenues from continuing operations reached $76.6 million.

2024 年第三季度，我們的持續營運收入達到 7,660 萬美元。

That's a 52% increase from Q3 2023, and 11% sequentially from the second quarter of 2024.

這比 2023 年第三季成長了 52%，比 2024 年第二季成長了 11%。

Exome and genome revenues grew 77% year over year and 18% sequentially, contributing $60 million this quarter.

外顯子組和基因組營收年增 77%，季增 18%，本季貢獻 6,000 萬美元。

The growth was driven by both volume and collection performance.

這一增長是由數量和收款表現共同推動的。

Adjusted gross profit from continuing operations for Q3 2024 was $49.3 million, which is up 103% compared to the same quarter last year and up 16% sequentially from the previous quarter.

2024 年第三季持續經營業務調整後毛利為 4,930 萬美元，較去年同期成長 103%，較上一季連續成長 16%。

That translates to a gross margin of 64% up from 48% a year ago and 62% last quarter.

這意味著毛利率為 64%，高於一年前的 48% 和上季的 62%。

Margin expansion benefited from all three of better average reimbursement rates, lower cost per test, and favorable mix shift.

利潤率的擴大得益於更好的平均報銷率、更低的每次測試成本和有利的組合轉變這三個因素。

Regarding volume and mix, exome and genome test accounted for 33% of all tests this quarter, up from 23% a year ago and 31% in the previous quarter.

就數量和組合而言，外顯子組和基因組測試佔本季所有測試的 33%，高於一年前的 23% 和上一季的 31%。

Our team delivered over 19,000 exome genome tests this quarter, that's up 46% year over year and 7% sequentially.

我們的團隊本季進行了超過 19,000 次外顯子組基因組測試，較去年同期成長 46%，較上季成長 7%。

We continue to expect an inevitable long-term replacement cycle of the industry's gene test and multi gene panels into exome and whole genome.

我們繼續預計，該行業的基因測試和多基因組將不可避免地出現長期更換週期，成為外顯子組和全基因組。

We're in the early innings of penetrating the outpatient specialist market and are poised to layer on the NICE service opportunity in the back half of 2025 and long term expect the pediatrician call point to open up, eventually exome genome will become standard first line diagnostics for nearly all [edible] disorders including adult disorder.

我們正處於滲透門診專科市場的早期階段，並準備在 2025 年下半年利用 NICE 服務機會，長期預計兒科醫生呼叫點將開放，最終外顯子組基因組將成為標準的一線診斷適用於幾乎所有[可食用]疾病，包括成人疾病。

On average reimbursement rates, all uplift have come from our efforts to reduce denial.

就平均報銷率而言，所有的提升都來自於我們為減少拒絕所做的努力。

In Q3, 2024 the average reimbursement rate for exome and genome after all denial was approximately $3,100 up from $2,800 last quarter and up from approximately $2,600 in the same quarter of last year.

2024 年第三季度，在所有拒絕後外顯子組和基因組的平均報銷率約為 3,100 美元，高於上季度的 2,800 美元，高於去年同期的約 2,600 美元。

Our work to refine insurance specific workflows to minimize administrative and procedural denials at commercial payers is paying off.

我們改進保險特定工作流程以最大程度地減少商業付款人的行政和程序拒絕的工作正在取得成效。

Additionally, Medicaid denials are decreasing as individual state policies evolve to cover exome and genome testing more broadly that surround sound of clinical and health economic data, patient advocacy, and biomarker bills are having a positive impact on policy and reimbursement decisions at the state level.

此外，隨著各州政策的發展以更廣泛地涵蓋外顯子組和基因組測試，圍繞臨床和健康經濟數據、患者倡導和生物標誌物法案的聲音對州一級的政策和報銷決策產生積極影響，拒絕醫療補助的情況正在減少。

This quarter, Connecticut, Florida, Indiana, and Texas all expanded or implemented enhanced policy.

本季度，康乃狄克州、佛羅裡達州、印第安納州和德州都擴大或實施了強化政策。

And while the state-by-state approach to expanding coverage is taking hold, we've also seen promising support at the federal level.

雖然各州擴大覆蓋範圍的方法正在紮根，但我們也看到了聯邦層級的有希望的支持。

Recently, CMS issued quote historic guidance to quote to state Medicaid agencies underscoring their obligations to provide all medically necessary services under the early and periodic screening diagnostic and treatment program for EPSDT, which entitles every Medicaid enrolled child to services that meet their unique medical needs including diagnostic tools like exome and genome sequencing.

最近，CMS 向州醫療補助機構發布了歷史指南，強調其有義務根據EPSDT 的早期和定期篩檢診斷和治療計劃提供所有醫療上必要的服務，該計劃使每個參加醫療補助的兒童有權獲得滿足其獨特醫療需求的服務，包括外顯子組和基因組定序等診斷工具。

On COGS, our team has optimized the wet lab, and we see further opportunity in the next several quarters to enhance efficiency throughout what today is fairly manual drive site process.

在 COGS 方面，我們的團隊優化了濕實驗室，我們看到在接下來的幾個季度中還有進一步提高整個當今相當手動駕駛現場流程效率的機會。

Turning to operating expense, total adjusting operating expense for Q3 2024 was $46.6 million.

說到營運費用，2024 年第三季的調整營運費用總額為 4,660 萬美元。

This team has built the skill set of balancing innovation and growth with financial discipline and stewardship to all that we do to drive leverage.

該團隊建立了平衡創新和成長與財務紀律和管理的技能，以及我們為提高槓桿率所做的一切。

And on the bottom line, total company adjusted net income for Q3 2024 was $1.2 million, marking the first positive quarter on that basis since inception.

總體而言，2024 年第三季公司調整後淨利潤總額為 120 萬美元，這是自成立以來第一個實現正成長的季度。

Our net cash burn for the third quarter was $5 million, an 88% improvement year over year and 17% improvement sequentially.

我們第三季的淨現金消耗為 500 萬美元，較去年同期改善 88%，較上季改善 17%。

This quarter marks our tenth consecutive quarter of cash flow improvement.

本季標誌著我們的現金流連續第十個季度改善。

On the balance sheet, our cash, cash equivalents, marketable securities, and restricted cash totalled $117.4 million as of September 30, 2024, inclusive of proceeds of $14.6 million net of fees for the issuance of 418,653 shares of common stock in connection with at the market sales during the third quarter of 2024.

在資產負債表上，截至2024 年9 月30 日，我們的現金、現金等價物、有價證券和限制性現金總計1.174 億美元，其中扣除與2024 年9 月30 日發行418,653 股普通股相關的費用後的收益為1,460 萬美元。

The outstanding share count as of September 30, 2024, stands at 27,433,803 Class A common shares.

截至 2024 年 9 月 30 日，已發行股數為 27,433,803 股 A 類普通股。

Now looking ahead, we're again raising our revenue guidance for the full year of 2024 to between $284 million and $290 million.

現在展望未來，我們再次將 2024 年全年營收指引上調至 2.84 億美元至 2.9 億美元之間。

We're also raising our adjusted gross margin guidance expecting it to be 62% for the whole year.

我們也提高了調整後毛利率指引，預計全年為 62%。

Additionally, we're improving our net cash burn guidance, now anticipating using $60 million to $65 million of net cash for the full year of 2024 excluding the financing process.

此外，我們正在改善淨現金消耗指引，目前預計 2024 年全年將使用 6,000 萬至 6,500 萬美元的淨現金（不包括融資流程）。

And with that, I'll turn you back to Katherine.

這樣，我就會把你轉回凱瑟琳那裡。

Thank you, Kevin.

謝謝你，凱文。

As we exit the third quarter, a profitable business, we're more confident than ever that we have a long runway of growth ahead of us, we've struck the balance between financial discipline and strategic investment, and we are in the privileged position that what's best for patients is also what's best for our business.

當我們結束第三季的獲利業務時，我們比以往任何時候都更有信心，我們前面還有很長的成長道路，我們已經在財務紀律和策略投資之間取得了平衡，並且我們處於有利地位對患者最好的也是對我們業務最好的。

While we continue to cement our leading position in the pediatric and rare disease market with substantial room to grow, we've turned our eyes towards the future, a future in which any genetic disorder is diagnosed quickly, prevent disease progression, and ensure long and healthy lives for all.

雖然我們繼續鞏固我們在兒科和罕見疾病市場的領先地位並擁有巨大的成長空間，但我們已經將目光轉向未來，在這個未來，任何遺傳性疾病都能得到快速診斷，防止疾病進展，並確保長期和持續的治療。

Fueled by our dedication to a healthier tomorrow, we're committed to ending the diagnostic odyssey today.

在我們致力於更健康的明天的推動下，我們致力於結束今天的診斷之旅。

We're not just imagining a healthier future, we're building it one diagnosis at a time.

我們不只是想像一個更健康的未來，我們一次只做出一個診斷。

And with that, we'll open it up to question.

至此，我們將對其進行質疑。

(Operator Instructions) Dan Brennan, TD Cowen.

（操作員說明）Dan Brennan，TD Cowen。

Great.

偉大的。

Thanks for the question.

謝謝你的提問。

Congrats on a strong quarter.

恭喜季度表現強勁。

Maybe the first one just on the guidance, pretty healthy raise.

也許第一個只是在指導上，相當健康的加薪。

Can you just give us a sense on how we're thinking about the fourth quarter?

您能否讓我們了解一下我們對第四季的看法？

Obviously, you're pointing to around $80 million.

顯然，你指的是大約 8000 萬美元。

But when you think about the volume price for exomes and genomes maybe.

但當你考慮外顯子組和基因組的批量價格時，也許會這樣。

Can you just give us some flavor there?

你能給我們一些味道嗎？

And how does like your fourth quarter guide now compare to kind of normal seasonality?

現在你的第四季指南與正常的季節性相比如何？

Yeah.

是的。

Hi, Dan.

嗨，丹。

Good morning.

早安.

Look, we're really pleased with the progress of the business continued momentum heading into fourth quarter.

看，我們對進入第四季度的業務持續成長勢頭感到非常滿意。

We previously talked that Q4 is typically seasonally strongest.

我們之前談到，第四季通常是季節性最強的。

That said, the early part of the fourth quarter here was impacted some by the weather down in the southeast, the hurricanes and tornadoes.

也就是說，第四季初期受到東南部天氣、颶風和龍捲風的影響。

So wanted to leave some room to see how long until we see a snap back there.

所以想留一些空間，看看我們要多久才能看到迴響。

At the same time as we talked throughout the year wanting to leave some room in the guide if we were to make some unilateral decisions with respect to the non-exome and non-genome portion of the portfolio, namely hereditary cancer, and some other non-exome tests.

同時，我們全年都在談論，如果我們要對投資組合的非外顯子組和非基因組部分（即遺傳性癌症和其他一些非外顯子組）做出一些單方面決定，希望在指南中留出一些空間。

We expect and that the fourth quarter will be seasonally stronger but left some room in the guide there for some of those to toggle.

我們預計第四季度將季節性強勁，但在指南中留有一些空間供其中一些進行切換。

And could you give us -- I mean, obviously the prepared remarks, spoke to, you know, the early nature where you sit today.

你能否給我們——我的意思是，顯然是準備好的講話，你知道，你今天坐的早期性質。

Despite the really strong growth, you've got a lot of upside across a lot of different planes, you know, the volume growth really good in the quarter and you are against a tough comp and the comp gets harder in the fourth quarter.

儘管成長非常強勁，但在許多不同的飛機上都有很大的上升空間，你知道，本季的銷售成長非常好，而且你面臨著艱難的競爭，而第四季的競爭變得更加艱難。

So just give us a little flavor of kind of, you know, maybe between outpatient and inpatient, maybe new accounts versus existing accounts.

因此，請給我們一點感覺，你知道，也許是門診病人和住院病人之間的關係，也許是新帳戶與現有帳戶之間的關係。

Any color on kind of what's driving that really strong volume, both exome and genomes.

任何顏色都顯示是什麼推動瞭如此強勁的數量，包括外顯子組和基因組。

Yeah, we're still seeing a tremendous amount of growth with new accounts and with same store sales in that outpatient setting, which again is predominantly our exome business.

是的，我們仍然看到門診環境中新客戶和同店銷售的巨大成長，這又是我們的外顯子業務的主要部分。

But I would say we did start to see because of some product improvements.

但我想說的是，由於一些產品的改進，我們確實開始看到這一點。

Last quarter, we have seen some nice growth on the NICU side of things as well as we turn our sites towards really ensuring that we can translate that same leadership that we have in exome to genome in the NICU setting.

上個季度，我們在NICU 方面看到了一些不錯的增長，並且我們將我們的網站轉向真正確保我們能夠將我們在NICU 環境中的外顯子組到基因組中的相同領導力轉化為同樣的領導力。

So, you know, we've ramped up our commercial efforts there.

所以，你知道，我們已經加大了在那裡的商業努力。

We've talked about the future with Aura.

我們已經與 Aura 討論了未來。

We are continuing to improve beyond, sample collection that we released, a cheap swab for that NICU setting.

我們正在繼續改進我們發布的樣本收集，這是適用於 NICU 環境的廉價拭子。

We'll have faster turnaround times.

我們將有更快的周轉時間。

We will have repeat expansions, all of which will help really continue to support our growth in that NICU setting as we head into 2025.

我們將進行重複擴張，所有這些都將有助於在進入 2025 年時真正繼續支持我們在 NICU 環境中的成長。

So I think we're really pleased to see kind of a diversification beyond the outpatient exome setting and starting to see some movement in that NICU setting, which I think just sets us up for a really strong outlook on 2025 grows in both settings.

因此，我認為我們真的很高興看到門診外顯子組環境之外的多元化，並開始看到NICU 環境中的一些變化，我認為這讓我們對2025 年這兩種環境的成長前景抱有非常強勁的前景。

And if I could speak one last one in the, you know, the CMS program you talked about in the prepared remarks, historic guidance, as you called it on State Medicaid plans.

如果我可以談談您在準備好的評論中談到的 CMS 計劃、歷史性指導（正如您在州醫療補助計劃中所稱的那樣）的最後一個主題。

Can you just elaborate a bit?

能詳細說明一下嗎？

Does this essentially force Medicaid plans to adopt testing?

這是否實質上迫使醫療補助計劃採用測試？

When can you start accruing more broadly across those states that aren't kind of covering it today?

您什麼時候可以開始在那些目前尚未涵蓋的州進行更廣泛的累積？

So just give us a sense on you know, that program and its potential impact.

因此，請讓我們了解該計劃及其潛在影響。

Yeah, I wouldn't go that far, Dan, with it.

是的，丹，我不會走那麼遠。

There's no real forced mechanism there.

那裡沒有真正的強制機制。

It's more of a reinforcement of what is existing guidance by CMS to individual state programs for a unique program for early childhood diseases and disorders for states to cover where there's unique and special needs.

它更多是對 CMS 對各州計劃的現有指導的強化，為各州制定針對幼兒疾病和失調的獨特計劃，以涵蓋各州的獨特和特殊需求。

And we think much of our testing fits into that mold of unique and special needs.

我們認為我們的大部分測試都符合獨特和特殊需求的模式。

But I wouldn't overstate to say that there's an enforcement regimen in place there.

但我不會誇大地說，那裡有一套執行製度。

William Bonello, Craig Hallum Capital Group.

威廉·博內羅，克雷格·哈勒姆資本集團。

Hey, good morning, guys.

嘿，早上好，夥計們。

Thanks for taking the question.

感謝您提出問題。

Just a couple of quick things.

只是一些快速的事情。

Can you talk a little bit about some of the actual initiatives that you have in place to drive increased penetration with the pediatric neurologists?

您能否談談您為提高兒科神經科醫生的滲透率而採取的一些實際舉措？

What do you do to get more of them using the testing and where do you think penetration can go over time?

您如何透過測試獲得更多的用戶？

And then I have, you know, one follow up.

然後，你知道，我有一個後續行動。

Perfect.

完美的。

You know, I think there's a number of things that are impacting utilization in the pediatric neurology setting and, and I guess at a high level there's our own efforts.

你知道，我認為有很多因素影響著兒科神經病學環境的利用率，而且我想在高水準上有我們自己的努力。

But they are I think joined by guidelines from the American Epilepsy Society that really amplify the need for exome testing for any child who has a seizure.

但我認為美國癲癇協會的指導方針也加入了這些指導方針，這些指導方針確實增強了對任何癲癇發作的兒童進行外顯子組檢測的必要性。

And then I think it's further amplified by continued reimbursement in that setting.

然後我認為在這種情況下持續的報銷會進一步放大這種情況。

Not to mention the fact that there are many companies on the biopharma side of things who are all out there educating pediatric neurologists in order to really fuel their clinical trials and their pipeline for FDA-approved therapy.

更不用說事實上，有許多生物製藥公司都在為兒科神經科醫生提供教育，以真正推動他們的臨床試驗和 FDA 批准的治療方案。

So there's really this incredible ecosystem play that is happening in order to benefit these children.

因此，為了讓這些孩子受益，確實正在發生這種令人難以置信的生態系統遊戲。

So there's not only a diagnosis, but there's something that is clinically actionable on the other side of that diagnosis by way of a study or an FDA-approved therapy.

因此，不僅有診斷，而且還可以透過研究或 FDA 批准的療法在診斷的另一面進行臨床操作。

The work that we're doing on the sales and medical fair side of things is we're going, we're showing them data that really ensures that they understand the importance of getting a precise genetic diagnosis and not just doing a brain scan but really understanding, if there is an underlying genetic cause for these seizures in particular, you need to know exactly what is happening from a genetic standpoint in order to be eligible for those clinical trials or FDA-approved therapies.

我們在銷售和醫療公平方面所做的工作是，我們向他們展示數據，真正確保他們了解獲得精確基因診斷的重要性，而不僅僅是進行腦部掃描，而是真正理解的是，如果這些癲癇發作有潛在的遺傳原因，您需要從遺傳的角度確切地了解發生了什麼，以便有資格參加這些臨床試驗或FDA 批准的治療。

And so, it's very similar to the phenomenon that you see on the cancer side of things and that you have seen on the cancer side of things for many years.

因此，這與您在癌症方面看到的現象非常相似，而且您多年來在癌症方面看到的現象非常相似。

We have a lot of education still to do just about how much more within reach our testing is.

關於我們的測試還有多少可能實現，我們還有很多工作要做。

Historically, it took a long time.

從歷史上看，這需要很長時間。

It was expensive and it was confusing once you got an answer.

它很昂貴，而且一旦你得到答案就會感到困惑。

But thanks to the technology improvements and scale that we've been able to build into our business, our turnaround times are now in the three-week range versus even at a four-week range.

但由於我們已經能夠在業務中建立技術改進和規模，我們的周轉時間現在在三週範圍內，甚至在四周範圍內。

Reimbursement is really strong in that setting.

在這種情況下，報銷確實很強大。

So it takes price off the table for most of the patients, four out of five have no out of pocket.

因此，對大多數患者來說，價格就不再是問題了，五分之四的患者不需要自掏腰包。

And then because we're continuing to resolve variants of unknown significance for upgrading and downgrading them, these results are actually more conclusive and less confusing.

然後，因為我們正在繼續解決對升級和降級具有未知意義的變體，所以這些結果實際上更具決定性且不那麼混亂。

So there's a number of things that we're doing to really educate pediatric neurologists about why they should use genetic testing versus other modalities that are inconclusive and continue to drive cost in the healthcare system and why we are easier to work with.

因此，我們正在做很多事情來真正教育兒科神經科醫生，讓他們了解為什麼他們應該使用基因檢測，而不是其他尚無定論並繼續增加醫療保健系統成本的方法，以及為什麼我們更容易合作。

That's really helpful.

這真的很有幫助。

And we just on that -- where do you think penetration could maybe go?

我們只是討論這一點——您認為滲透率可能會走向何方？

So, as we said earlier, we're at about 12%.

所以，正如我們之前所說，我們的比例約為 12%。

We're aiming to make sure that every pediatric neurologist who has a child with a seizure is getting a genetic test.

我們的目標是確保每位患有癲癇兒童的兒科神經科醫生都接受基因檢測。

So as we've talked about the total addressable market, and the outpatient setting being about $2 billion that doesn't contemplate really an expansion of testing beyond ICD-10 codes, which is what we're really driving towards.

因此，正如我們所討論的總可尋址市場以及約 20 億美元的門診環​​境，並未真正考慮將測試擴展到 ICD-10 代碼之外，而這正是我們真正推動的目標。

We want to make sure that any child who has several of these symptoms, whether it is persistent seizures, if it's missed milestones, it's usually a combination of multiple different types of symptoms that are showing up.

我們希望確保任何出現其中幾種症狀的孩子，無論是持續性癲癇發作，還是錯過了里程碑，通常都是多種不同類型症狀的組合出現。

That genetic testing is being used as early as possible to prevent progression of disease.

儘早使用基因檢測來預防疾病進展。

So we think that every pediatric neurologist should be utilizing this testing for these children who are showing up as a first line of treatment and again, AES guidelines support that.

因此，我們認為每位兒科神經科醫生都應該對這些作為一線治療的兒童使用這項測試，AES 指南也支持這一點。

And so, we'll continue to work alongside AES patient advocacy groups are wonderful partners in terms of educating providers as well to make sure that everyone has access to the testing.

因此，我們將繼續與 AES 患者倡導團體合作，他們是教育提供者的出色合作夥伴，並確保每個人都能獲得測驗。

Okay.

好的。

That's great.

那太棒了。

And then just the second question I had was just on the NICU penetration and sort of how we think about the ramp there. are there accounts that are essentially, you know, preparing to turn on you know, rapid whole genome test once you are live and launched with Epic?

我的第二個問題是關於新生兒加護病房的滲透率以及我們如何看待那裡的坡道。是否有帳戶本質上準備在 Epic 上線並啟動後啟動快速全基因組測試？

Or do we think of that as more kind of the, the starting date?

或者我們認為這更像是開始日期？

And then there's a bit of a delay as accounts, you know, prepare to launch?

然後，當帳戶準備啟動時，會出現一些延遲？

It's both.

兩者都是。

So we are currently selling and actively driving volumes and institutional pay today.

因此，我們目前正在銷售並積極推動銷售和機構薪酬。

So we are able to start bringing on business and realizing that the benefits for their patients today and for our business today.

因此，我們能夠開始開展業務，並認識到這對他們今天的患者和我們今天的業務都有好處。

So that is happening.

所以這種情況正在發生。

Again, just as a reminder for everyone, this is an enterprise sales approach.

再次提醒大家，這是一種企業銷售方式。

So we're going in -- our Chief Medical Officer, our enterprise sales team will go in and sell a system wide approach to embedding testing.

因此，我們的首席醫療官、我們的企業銷售團隊將介入並銷售一種全系統的嵌入測試方法。

Without a doubt, we believe that Epic Aura will be an important catalyst.

毫無疑問，我們相信史詩光環將是重要的催化劑。

Next year, we'll begin actually accepting orders through that in the first half of the year and we expect that we'll start to see the impact of that in the second half of the year.

明年，我們將在上半年開始實際接受訂單，預計下半年我們將開始看到其影響。

So we're continuing to do what I would call blocking and tackling in, in some of these health systems with the improvements that we've had.

因此，我們將繼續在其中一些衛生系統中進行我所說的阻止和應對工作，並取得我們已經取得的進展。

Several of these health systems, they're partnering with us in the outpatient setting.

其中一些衛生系統正在與我們在門診環境中合作。

So it's a natural extension into that NICU setting.

因此，這是 NICU 環境的自然延伸。

But next year as we think about the potential to really drive more meaningful volumes and revenues and importantly, more diagnoses faster for more of these families.

但明年，當我們考慮真正推動更有意義的銷售和收入的潛力時，更重要的是，為更多的這類家庭提供更快的更多診斷。

We think that the epic partnership is going to be an important catalyst for us.

我們認為，史詩般的合作關係將成為我們的重要催化劑。

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

Hey guys, thank you very much for the questions and congrats on the quarter.

大家好，非常感謝你們提出的問題，並對本季表示祝賀。

I wanted to start on the JAMA study and the Guardian read out, pretty impressive stuff.

我想開始《美國醫學會雜誌》的研究，《衛報》讀了非常令人印象深刻的東西。

So I guess multi part question here.

所以我想這裡有多個部分的問題。

First, can you remind us who is paying for the study?

首先，您能提醒我們誰支付了研究費用嗎？

I see it, it's a collaboration among academic institutions and Alumina is involved as well, but I just wanted to double check how much of this study you guys are paying for?

我明白了，這是學術機構之間的合作，Alumina 也參與其中，但我只是想仔細檢查一下你們為這項研究支付了多少費用？

How it relates to cash burn?

它與現金消耗有何關係？

And then secondly, when do you expect to commercially launch your exome product to newborns?

其次，您預計什麼時候會向新生兒推出您的外顯子組產品？

And then the third one is more on the medical affairs or payer strategy side.

第三個更多的是醫療事務或付款人策略方面。

How are you thinking about, you know, starting to potentially work with medical societies and getting payers to pay for, you know, newborn screening?

您如何考慮開始與醫學會合作並讓付款人支付新生兒篩檢費用？

I know a number of us are familiar with [Natera's] strategy in microdeletion screening and it has taken them a little bit of time, getting in front of ACOG.

我知道我們中的許多人都熟悉 [Natera] 的微缺失篩選策略，他們花了一點時間才到達 ACOG 的面前。

So maybe help us if -- determine if ACOG is one of these groups but give us a sense for timing both on commercial launch and on guidelines.

因此，也許可以幫助我們確定 ACOG 是否是這些組織之一，但可以讓我們了解商業發布和指導方針的時機。

Yeah.

是的。

Maybe, Mark, I'll start with that first one.

也許，馬克，我會從第一個開始。

So it's effectively in kind consideration by each partner in the Guardian study -- so that would include GeneDx, Alumina, New York State and New York Presbyterian.

因此，衛報研究中的每個合作夥伴實際上都在善意地考慮——其中包括 GeneDx、Alumina、紐約州和紐約長老會醫院。

The lead PI is Wendy Cheung.

首席 PI 是 Wendy Cheung。

She was formerly with Columbia.

她以前曾在哥倫比亞大學工作。

Now she's with Boston Children's Hospital with Wendy and her team contributing principal investigation type of work, alumina providing reagents, GeneDx providing the actual sequencing and interpretation and so our labor and know-how effort there, each contributing what we do best at, frankly, within no cost to the families involved in this.

現在她在波士頓兒童醫院工作，Wendy 和她的團隊貢獻了主要的研究類型工作，氧化鋁提供了試劑，GeneDx 提供了實際的測序和解釋，因此我們在那裡付出了勞動和專業知識，坦率地說，每個人都貢獻了我們最擅長的事情，參與此事的家庭無需承擔任何費用。

In terms of timing and pair strategy, one, I want to re-emphasize some of the comments that we made that the absence of this testing is indeed funneling children through this multi-year 6-to-8-year diagnostic odyssey.

就時間安排和配對策略而言，第一，我想再次強調我們提出的一些評論，即缺乏這種測試確實讓孩子們經歷了這場長達 6 至 8 年的診斷之旅。

And that's a big problem that we have to continue to solve today.

這是我們今天必須繼續解決的一個大問題。

But I think with that as a backdrop, I think it really further cements how important it is that we continue to accelerate the opportunity in the newborn screening setting.

但我認為以此為背景，我認為這確實進一步鞏固了我們繼續加速新生兒篩檢機會的重要性。

It's going to take a lot of work.

這需要做很多工作。

We talk about the GUARDIAN study is being proof of principle.

我們談論的 GUARDIAN 研究是原理證明。

Wendy has done a masterful job in showing that she can generate the attention and interest in prospective parents, so more than 70% of parents enroll in the study.

溫迪出色地證明了她能夠引起準父母的注意和興趣，因此超過 70% 的父母參加了這項研究。

But the key question of course is going to be who's going to pay for it.

但關鍵問題當然是誰來買單。

And we think that that's going to take us several years to really continue to make sure that policymakers appreciate it, that we can figure out exactly what that pull through strategy is going to be.

我們認為，這將需要我們幾年的時間才能真正繼續確保政策制定者理解這一點，確保我們能夠準確地弄清楚推動策略的內容。

I tend to be optimistic about our ability to solve the business problems of it.

我傾向於對我們解決業務問題的能力持樂觀態度。

I think if you -- there was just the international conference on newborn screening here in New York a couple weeks ago, and all of the researchers I think are coalesced around there is great evidence, particularly given the fact that this is the largest study that's been done in the US.

我想，如果你——幾週前在紐約剛剛舉行了新生兒篩檢國際會議，我認為所有研究人員都聚集在一起，就會有很好的證據，特別是考慮到這是迄今為止規模最大的研究。

There's great evidence on clinical actionability, 4% is what we're seeing.

有大量證據表明臨床可操作性，我們所看到的為 4%。

But the business problems that we have to solve, that's what we're really good at, at GeneDx.

但我們必須解決的業務問題才是 GeneDx 真正擅長的。

And so, we're going to take our commercial team, our medical affairs team, we're going to continue to figure out the health economic argument.

因此，我們將帶著我們的商業團隊、我們的醫療事務團隊，繼續找出健康經濟的論點。

That really goes beyond the clinical utility that we're seeing in the GUARDIAN study.

這確實超出了我們在 GUARDIAN 研究中看到的臨床效用。

So I think our view on it remains, it will be in the five plus year time frame before it really starts to take off in a meaningful way.

因此，我認為我們對此的看法仍然存在，它將在五年多的時間內真正開始以有意義的方式起飛。

But we are spending time on it today to make sure that we can be the ones who work with the entire ecosystem, including biopharma companies who have a really important interest.

但我們今天花時間在這上面，以確保我們能夠成為與整個生態系統合作的人，包括擁有真正重要利益的生物製藥公司。

Several biopharma companies and patient advocates are the reasons that we have expanded from 200 conditions that we're screening for to 450.

幾家生物製藥公司和患者權益倡導者幫助我們將篩檢的病症從 200 種擴大到 450 種。

So we'll work in collaboration with all of them to figure out the commercial strategy and the payer strategy for that as well.

因此，我們將與他們所有人合作，制定商業策略和付款人策略。

Okay.

好的。

That is really helpful.

這真的很有幫助。

And then one for you, Kevin, I know you talked about your ASPs on exome and genome hit $3,100 in the quarter.

然後是你，Kevin，我知道你談到了本季外顯子組和基因組的 ASP 達到了 3,100 美元。

That's up $500 year over year.

年增 500 美元。

I don't think you have, but do you think you've hit a wall there or at least have you reached a limit on the $3,100?

我不認為你有，但你是否認為你已經碰壁了，或者至少達到了 3,100 美元的上限？

Just give us a sense.

只是給我們一個感覺。

I know that when you get paid in full, I think you're a little bit higher than that.

我知道當你拿到全額薪水時，我認為你的薪水會比那高一點。

So I'm just trying to get a sense as we are tweaking our models for 2025 and perhaps beyond, how should we think about the upper limit of realizing ASPs on exome, genome?

所以我只是想了解一下，當我們調整 2025 年甚至更遠的模型時，我們應該如何考慮在外顯子組、基因組上實現 ASP 的上限？

Yes.

是的。

Maybe one way I contextualize, Mark, is we're still at a point where our payment rate is in the mid-50s and certainly believe the mature product in our space over time.

馬克，我的一種理解是，我們的支付率仍處於 50 多歲的水平，並且相信隨著時間的推移，我們領域的產品會變得成熟。

One that we believe fills a large unmet medical need and really make an impact on care ought to have a much higher payment rate than that, at least 70% to 80%.

我們認為，如果能滿足大量未滿足的醫療需求並真正對護理產生影響，支付率應該遠高於此，至少 70% 至 80%。

So still a long way to go.

所以還有很長的路要走。

To ensure we're getting paid consistently at normalized rates there.

確保我們能夠持續按照標準化費率獲得報酬。

So we consider the $3,100 here.

所以我們這裡考慮 3,100 美元。

A new form, which will challenge ourselves to continue to reduce denials.

一種新的形式，這將挑戰我們自己，繼續減少否認。

In large part, many of them still remain administrative and procedural.

在很大程度上，其中許多仍然是行政和程序性的。

I'm really pleased with the progress the team has made about a year ago.

我對團隊大約一年前的進展感到非常滿意。

We invested a lot of resources in terms of people and technology, and it's paying off.

我們在人力和技術方面投入了大量資源，並且正在取得回報。

So certainly, optimistic that we can continue -- improvement there.

當然，我們樂觀地認為我們可以繼續改進。

Awesome.

驚人的。

And then last one for me.

然後是我的最後一張。

It's for you, Katherine.

這是給你的，凱瑟琳。

You talk about longer term; you want to provide exome and genome tests to adults.

你談論的是更長期的；您想為成年人提供外顯子組和基因組測試。

Is there sort of a Guardian study for adults in the works?

是否有針對成年人的衛報研究正在進行中？

Can you just give us a sense for what you're doing in terms of getting in front of collaborators to show the evidence of why this test would be helpful in adults?

您能否讓我們了解一下您在合作者面前所做的工作，以證明為什麼這項測試對成年人有幫助？

Certainly.

當然。

I think one of the key principles for us over the past several years that has differentiated us from loves of past is making sure we can get paid as often as possible for our testing.

我認為過去幾年我們與過去的愛人不同的關鍵原則之一是確保我們能夠盡可能地通過測試獲得報酬。

So we're going to continue to drive a business where there is line of sight between volume and getting paid for it.

因此，我們將繼續推動業務量與收入之間存在視線範圍。

I think as we think about the exult setting, there's a few areas that come to mind for us.

我認為當我們想到歡欣鼓舞的環境時，我們會想到幾個面向。

One is, of course, adult neurodegenerative conditions like Parkinson's and Alzheimer's disease, amongst others.

當然，其中之一是成人神經退化性疾病，如帕金森氏症和阿茲海默症等。

And really thinking about drug development in those areas and others on the cardiovascular side of things.

並真正考慮這些領域和心血管方面其他領域的藥物開發。

And again, taking a look at where biopharma companies are investing -- are investing their capital as well.

再說一次，看看生物製藥公司正在投資的地方——也在投資他們的資本。

So we're going to work in a really deliberate way to ensure that as we think about an adult opportunity in the future, it is, again, that total ecosystem play, ensuring we generate data to get in front of payers, ensuring that payers are going to pay for it.

因此，我們將以一種真正深思熟慮的方式開展工作，以確保當我們考慮未來的成人機會時，整個生態系統都會發揮作用，確保我們產生數據以呈現在付款人面前，確保付款人我們將為此付出代價。

Seeing with biopharma companies, what their needs are because you can't treat it if you can't diagnose it.

看看生物製藥公司，他們的需求是什麼，因為如果不能診斷就無法治療。

So where there are gene therapies, you need a genetic diagnosis.

因此，只要有基因療法，就需要基因診斷。

The way that I would say though, Mark, I think it still remains a -- like an exome, genome test versus a screen.

不過，馬克，我認為它仍然是一種——就像外顯子組、基因組測試與篩選一樣。

In the future, when we get to a place where we are doing newborn screening at birth for all babies, I could see us at that point in time, and the future flip to being able to do a sequence and hold on adults as well.

將來，當我們到達對所有嬰兒出生時進行新生兒篩檢的地方時，我可以在那個時間點看到我們，並且未來將能夠進行序列檢查並同時對成人進行篩檢。

We haven't begun scoping out what that could look like beyond that being an important vision and North

我們還沒有開始探討除了重要的願景之外，這可能會是什麼樣子，諾斯

[Star grass].

【星草】。

But I would almost view the adult market as being an extension of the test-by-test symptomatic market versus screening market as we look to be able to continue to open up access to broader patient population.

但我幾乎將成人市場視為逐次測試的症狀市場與篩檢市場的延伸，因為我們希望能夠繼續向更廣泛的患者群體開放。

Matt Sykes, Goldman Sachs.

馬特·賽克斯，高盛。

Congrats on another good quarter.

恭喜又一個美好的季度。

I guess I just wanted to -- more of a modeling question, but -- maybe just talk a little bit about the impact of prior period collections.

我想我只是想——更多的是一個建模問題，但是——也許只是談談前期系列的影響。

I think you did $6.3 million this quarter, down from $7 million last quarter.

我認為本季您的收入為 630 萬美元，低於上季度的 700 萬美元。

But just given the profile of that revenue, I assume it had an outsized impact on profitability.

但考慮到該收入的概況，我認為它對盈利能力產生了巨大的影響。

And so just from a modeling perspective, Kevin, I guess how should we think about moving forward the prior period collections?

因此，從模特兒的角度來看，凱文，我想我們應該如何考慮推進前期系列？

Any kind of trends that you could help us out with?

您可以幫助我們解決哪些趨勢？

And what was the impact to profitability from that revenue coming in year-to-date?

今年迄今的收入對獲利能力有何影響？

Yeah, as you pointed out, there's about $6 million of estimate true-ups, although I've put that in the context of true-up spending a number of months or actually quarters.

是的，正如您所指出的，估計的真實成本約為 600 萬美元，儘管我將其放在數月或實際上幾季的真實成本背景下。

And the way I would think about it is that the GAAP calculations themselves tend to look at a historic look-back period to estimate collection rates by payer.

我的想法是，公認會計原則計算本身傾向於查看歷史回顧期來估計付款人的收款率。

And frankly, we've been outperforming past estimates.

坦白說，我們的表現超出了過去的預期。

That's where we want to be with respect to those true-ups and still think we're in a -- a cycle where there's a number of quarters to come where we'll be on that side of the ledger.

這就是我們想要實現的目標，並且仍然認為我們正處於一個週期中，在接下來的幾個季度裡，我們將處於帳簿的這一側。

So do you view sort of the rev rec rate of $3,100 that you can derive from our table in the back of the release as a new floor in which we'll build for GAAP revenue purposes moving forward.

那麼，您是否認為 3,100 美元的收益回報率可以從我們在新聞稿後面的表格中得出，作為一個新的下限，我們將在這個下限中為未來的 GAAP 收入目的而構建。

Okay.

好的。

And then one for probably both Katherine and Kevin.

然後可能是凱瑟琳和凱文的一份。

Just given the increase you've seen in all exome and genome revenues, would you consider being more aggressive about either winding down or disposing of some of your non-genome, exome testing.

鑑於您所看到的所有外顯子組和基因組收入的成長，您是否會考慮更積極地逐步結束或處置一些非基因組、外顯子組測試。

I think Kevin, you mentioned in response to the first question just about hereditary cancer.

我想凱文，您在回答第一個問題時提到了關於遺傳性癌症的問題。

Maybe something you called out.

也許是你喊出來的東西。

But would this be -- how do you consider sort of the revenue versus margin implications?

但這會是—您如何考慮收入與利潤率的影響？

Because they're pretty significant for our modeling and just for the overall company.

因為它們對於我們的建模以及整個公司來說非常重要。

And if you were to be more aggressive about wanting that down could you sell some of these types of tests like hereditary cancer?

如果你更積極地想要降低這一點，你可以出售一些這類測試，例如遺傳性癌症嗎？

Or would it just be sort of winding down that business as the exome genome grows?

或者說，隨著外顯子組基因組的成長，這項業務會逐漸減少嗎？

Sure, I'll kick it off and then hand it over to Kevin.

當然，我會把它踢掉然後交給凱文。

I think as we look back from a year ago, we've now retired 70% of our test menu.

我認為，當我們回顧一年前時，我們現在已經淘汰了 70% 的測試菜單。

And so, we've made really meaningful progress in setting the lower negative gross margin test and really staying focused on test that one, provide the best patient care to ensure that there is healthy gross margin, and we'll continue to wind down task Kevin mentioned in the fourth quarter, continuing to have an eye for winding down additional tests from that menu.

因此，我們在設定較低的負毛利率測試方面取得了真正有意義的進展，並真正專注於測試這項測試，提供最好的患者護理，以確保有健康的毛利率，我們將繼續逐步完成任務凱文在第四季度提到，繼續著眼於從該選單中逐步減少額外的測試。

So I'm pleased that we've been able to make so much progress and we do want to get to a place where we have a two- test menu in exome and genome, ultimately running everything -- exome, genome for all.

因此，我很高興我們能夠取得如此大的進展，我們確實希望能夠在外顯子組和基因組方面擁有兩個測試選單，最終運行所有內容——外顯子組、基因組。

So -- we do want to get to that place over time, but again, making sure that there's a clear reimbursement pathway.

因此，我們確實希望隨著時間的推移實現這一目標，但再次確保有明確的報銷途徑。

Yeah.

是的。

The only thing I'd add to that, Matt, is, as Katherine said, returning about 70% of the test menu in the past year, what remains maybe putting aside hereditary cancer for a moment.

馬特，我唯一要補充的是，正如凱瑟琳所說，去年返回了大約 70% 的測試菜單，剩下的可能暫時放在一邊。

Outside of that line, what remains in the non-exnome, non-genome test line are all tests that we believe are long term strategically important in that they would expect to convert to exome and genome once additional guidelines are put out.

在那條線之外，非外顯子組、非基因組測試線中剩下的都是我們認為具有長期戰略重要性的測試，因為一旦推出額外的指導方針，它們將有望轉換為外顯子組和基因組。

The largest portion of that volume line is coromosonal micro-array represents about 20% of all volume.

此體積線的最大部分是冠狀微陣列，約佔所有體積的 20%。

That test, we do think long term is absolutely a great candidate to convert to exome and genome.

我們確實認為，從長遠來看，該測試絕對是轉換為外顯子組和基因組的絕佳候選者。

And so strategically important.

因此具有戰略重要性。

And at the same time, over the last year, we've made strides to improve the COGS profile of the remaining portfolio.

同時，在過去的一年裡，我們在改善剩餘投資組合的銷貨成本方面取得了長足進展。

CMA 1 example where it was about 30% negative gross margin a year ago.

以 CMA 1 為例，一年前毛利率約為 30% 的負值。

We've gotten that to about breakeven.

我們已經達到了收支平衡。

With we think a path to further improve upon that.

我們思考進一步改進的途徑。

So a lot of rigor going into what is the remaining test menu, as Katherine alluded to, with a filter to say, is it margin positive and accretive and/or a good strategic fit to build the exome, genome business over time.

因此，正如凱瑟琳所提到的那樣，對剩下的測試菜單進行了很多嚴格的審查，並進行了篩選，即它是否具有積極的利潤和增值性和/或隨著時間的推移建立外顯子組、基因組業務的良好策略契合度。

Brandon Couillard, Wells Fargo.

布蘭登‧庫亞爾，富國銀行。

Katherine in relations on crops in the profitability line.

凱瑟琳與農作物的獲利線關係。

How should we think about incremental investments over the next 6 to 12 months and now that you are profitable?

既然您已經獲利，我們該如何考慮未來 6 到 12 個月的增量投資？

Are there some projects that have maybe been on the shelf that will be priority to tap that list?

是否有一些可能已經被擱置的項目將被優先利用該清單？

And Kevin, how should we think about OpEx spend moving into '25 in that context?

Kevin，在這種背景下，我們該如何考慮進入 25 世紀的營運支出支出？

Awesome.

驚人的。

Thanks, Brandon.

謝謝，布蘭登。

I think you're absolutely right about the way that we're thinking about investments.

我認為您對我們思考投資的方式絕對正確。

We're going to make, I would say, discrete meaningful investments that ensure that we're balancing continued profitable growth while ensuring that we can innovate to continue to lead the way, not just in exome but in genome.

我想說，我們將進行離散而有意義的投資，以確保我們在持續盈利增長之間取得平衡，同時確保我們能夠創新以繼續引領潮流，不僅在外顯子組方面，而且在基因組方面。

So I think what we've seen this year already is our ability to place some of those disparate pets, whether it's Epic Aura, if it's putting capital behind improving our genome product which we've discussed all in the works.

所以我認為今年我們已經看到我們有能力放置一些不同的寵物，無論是史詩光環，還是投入資金改進我們在工作中討論過的基因組產品。

We already released our

我們已經發布了我們的

[Buckle slob].

[附扣懶鬼]。

We will have a five-day turnaround time, and we will have repeat expansions.

我們將有五天的周轉時間，我們將進行重複擴張。

So is continuing to make disparate investments like that, that will track the ROI of each one of those to make sure that they are paying off.

因此，繼續進行類似的不同投資，將追蹤每項投資的投資回報率，以確保它們得到回報。

We're going to make sure that we do it in a really methodical way.

我們將確保以真正有條理的方式來做這件事。

I'm happy to say that on the genome improvements, we started to see the results of that by way of volumes coming through.

我很高興地說，在基因組改進方面，我們開始透過數量的方式看到其結果。

And again, that's institutional pay.

再說一遍，這是機構薪酬。

So it's a really healthy business.

所以這是一項非常健康的業務。

So we're going to continue to strike a really healthy balance in terms of making the product improvement, the customer experience and the overall commercial growth investment and really deliberate and methodical in the way moving forward.

因此，我們將繼續在產品改進、客戶體驗和整體商業成長投資方面取得真正健康的平衡，並在前進的道路上真正深思熟慮和有條不紊。

Yeah, maybe just to layer on the broader team, functional teams have really built the muscle memory to look at ROI analysis, cost-benefit analysis, and we're still in a period where we expect payback in something like one to three years rather than three to five or beyond.

是的，也許只是為了在更廣泛的團隊中分層，職能團隊確實建立了肌肉記憶來查看投資回報率分析、成本效益分析，而且我們仍然處於預計在一到三年內獲得回報的時期，而不是超過三到五或更多。

So all investments will be measured with respect to where do we see near-term accelerators in terms of revenue growth or gross profit expansion.

因此，所有投資都將根據我們在收入成長或毛利擴張方面看到的近期加速器來衡量。

We see a number of things that we believe we can do to further accelerate the business.

我們認為可以採取許多措施來進一步加速業務發展。

So excited to analyze those.

很高興能夠分析這些。

But certainly, you should expect that we're taking the same level of rigor that got us to this point of bringing profitability moving forward.

但當然，您應該期望我們採取同樣的嚴格程度，使我們能夠實現盈利。

From an OpEx standpoint, maybe some incremental aggregate dollars, but still expect a period over the next year where that OpEx as a percent of revenue could slightly decline as revenue, gross profit outpace any incremental additions to OpEx.

從營運支出的角度來看，可能會增加一些總金額，但仍預計明年一段時間內，隨著收入、毛利超過營運支出的任何增量增加，營運支出佔收入的百分比可能會略有下降。

Okay.

好的。

That's helpful.

這很有幫助。

And then, Kevin, I think the guide implies gross margins actually stepped down a little bit sequentially in the fourth quarter.

然後，凱文，我認為該指南暗示毛利率實際上在第四季度連續下降了一點。

Is that just conservatism?

這只是保守主義嗎？

Is there some mix impact embedded in there?

其中是否存在某種混合影響？

And it would be helpful if you could update us on just the gross margin profile by test franchise and where you see the biggest opportunity for improvement?

如果您能為我們提供最新的測試特許經營毛利率概況以及您認為最大的改進機會在哪裡，將會很有幫助？

Yeah.

是的。

So the at least 62%, I'd say, two components of that one, it's at least 62%, so 62% or higher.

所以我想說，至少 62%，其中的兩個組成部分，至少是 62%，所以 62% 或更高。

And again, that's for the full year.

再說一遍，這是全年的。

And so there's some weighted math going on effectively expect margins to stay roughly flat with where they are in Q3 as we head into Q4.

因此，在進入第四季度時，進行了一些加權計算，有效地預計利潤率將與第三季的水平大致持平。

So the guide implies roughly flat, and we'll try to beat that.

因此，該指南意味著大致持平，我們將盡力克服這一點。

Matt Stanton, Jefferies.

馬特·斯坦頓，杰弗里斯。

Maybe one sticking with gross margins, Kevin.

也許是堅持毛利率，凱文。

3Q saw a more meaningful step-up than we saw in the first half from low 60s moving towards mid-60s or about 300 basis points.

與上半年相比，第三季出現了更有意義的提升，從 60 年代低點向 60 年代中期或約 300 個基點邁進。

I think you called out kind of mix reimbursement, better cost number of drivers of that?

我認為您提出了某種混合報銷，更好的司機數量？

Is there anything that was more meaningful than others?

有什麼事情比其他事情更有意義嗎？

Or was it kind of equal weighted?

還是同等權重？

And then as we start to think about '25, can you talk about some of the levers for ongoing improvement as we build off the updated '24, guide for the at least 62% on the gross margin side?

然後，當我們開始考慮「25」時，您能否談談我們在更新的「24」基礎上持續改進的一些槓桿，即毛利率至少達到 62% 的指南？

Yeah, I'd probably weight them with average reimbursement rate and then cost per test and then mix -- but where we continue to see opportunity moving forward is if you look at our COGS stack, about one-third of it resides in what I'll call the dry side processes.

是的，我可能會用平均報銷率和每次測試的成本來衡量它們，然後進行混合——但我們繼續看到前進的機會是，如果你看看我們的COGS 堆疊，大約三分之一存在於我的成本中。

So after the sequencer book before report writing or including report writing, still fairly manual steps today.

因此，在編寫報告之前或包括報告編寫之前的定序器書籍之後，今天仍然是相當手動的步驟。

With a lot of effort and resources going in manually.

手動投入大量精力和資源。

We think those processes are good candidates for further automation and so we're investigating any tools that might help us unlock further cost per test savings and would expect that component to have the bigger proportionate share of expansion gains as we head into '25 and beyond.

我們認為這些流程是進一步自動化的良好候選者，因此我們正在研究任何可能幫助我們進一步節省每次測試成本的工具，並期望隨著我們進入25 年及以後，該組件將在擴展收益中佔據更大的比例份額。

Okay.

好的。

That's really helpful.

這真的很有幫助。

And then nice to see the continued whole exome, genome sequencing coverage by the states.

然後很高興看到各州繼續涵蓋全外顯子組、基因組定序。

In terms of some of the more recent wins, how do we think about the larger states like Texas in September, Florida here in October on the whole genome side.

就最近的一些勝利而言，我們如何看待較大的州，例如 9 月的德克薩斯州、10 月的佛羅裡達州，從整個基因組的角度來看。

Can you just remind us on how quickly those coverage decisions can and will impact your business?

您能否提醒我們這些核保決策能夠以多快的速度影響您的業務？

Yes.

是的。

A typical lag of one to two quarters is not unreasonable.

一到兩個季度的典型滯後並非不合理。

And so I would really expect more of a ['25] impact for those states that we announced to enhance or put in policy this year.

因此，我確實預計我們今年宣布加強或實施政策的那些州會產生更多的 ['25] 影響。

.

。

Thank you.

謝謝。

And that does conclude the Q&A session for today.

今天的問答環節到此結束。

And I would like to go ahead and turn the call over to Katherine for closing remarks.

我想繼續將電話轉給凱瑟琳進行總結發言。

Please go ahead.

請繼續。

Great.

偉大的。

Well, thank you all for joining us.

好的，謝謝大家加入我們。

We look forward to seeing you at upcoming conferences.

我們期待在即將舉行的會議上見到您。

Thanks so much.

非常感謝。

Have a good day.

祝你有美好的一天。