GeneDx Holdings Corp (WGS) 2022 Q4 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Thank you for standing by, and welcome to GeneDx' Fourth Quarter 2022 Earnings Conference Call. (Operator Instructions) I would now like to hand the call over to Head of Investor Relations, Tricia Truehart. Please go ahead.

    感謝您的支持,歡迎來到 GeneDx 2022年第四季度收益電話會議。 (操作員說明)我現在想把電話轉給投資者關係主管 Tricia Truehart。請繼續。

  • Tricia Truehart

    Tricia Truehart

  • Thank you, Latif, and thank you to everyone who is joining us today on this call. I'm Tricia Truehart, Head of Investor Relations at GeneDx. On the call today, we have Katherine Stueland, Chief Executive Officer; and Kevin Feeley, Chief Financial Officer.

    謝謝 Latif,也感謝今天加入我們的所有人。我是 GeneDx 投資者關係主管 Tricia Truehart。在今天的電話會議上,我們有首席執行官 Katherine Stueland;和首席財務官 Kevin Feeley。

  • Earlier today, GeneDx released financial results for the fourth quarter and full year ended December 31, 2022. A copy of the press release and our fourth quarter earnings slide deck are available on the company's website.

    今天早些時候, GeneDx 發布了截至2022年12月31日的第四季度和全年的財務業績。新聞稿的副本和我們的第四季度收益幻燈片可在公司網站上找到。

  • Before we begin, I'd like to remind you that management will make forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements. Actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors. Additionally, these forward-looking statements, particularly our 2023 financial guidance, our expectations for revenue growth, gross margin and profitability over the next several years and our expected cost savings and reduction in cash burn involve a number of risks, uncertainties and assumptions. For a list and description of the risks and uncertainties associated with GeneDx' business, please refer to the Risk Factors section of our latest Form 10-K filed with the Securities and Exchange Commission and the other documents filed by us from time to time with the SEC. We urge you to consider these factors and you should be aware that these statements should be considered estimates only and are not a guarantee of future performance.

    在我們開始之前,我想提醒您,管理層將根據 1995 年《私人證券訴訟改革法案》的安全港條款作出聯邦證券法含義內的前瞻性陳述。本次電話會議涉及對未來事件、結果或業績的預期或預測,屬於前瞻性陳述。由於多種因素,實際結果可能與前瞻性陳述中明示或暗示的結果存在重大差異。此外,這些前瞻性陳述,尤其是我們的 2023 年財務指南,我們對未來幾年收入增長、毛利率和盈利能力的預期,以及我們預期的成本節約和現金消耗減少,涉及許多風險、不確定性和假設。有關與 GeneDx 業務相關的風險和不確定性的列表和描述,請參閱我們向美國證券交易委員會提交的最新 10-K 表格中的風險因素部分以及我們不時向美國證券交易委員會提交的其他文件。秒。我們敦促您考慮這些因素,您應該知道,這些陳述僅應被視為估計,不能保證未來的表現。

  • During the call, we may discuss certain non-GAAP financial measures. For reconciliations of the non-GAAP measures to GAAP financial measures as well as other information regarding these measures, please refer to our earnings release and other materials in the Investor Relations section of our website. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, March 14, 2023. GeneDx disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. And with that, I will turn the call over to Katherine.

    在電話會議期間,我們可能會討論某些非 GAAP 財務指標。有關非 GAAP 措施與 GAAP 財務措施的協調以及有關這些措施的其他信息,請參閱我們網站投資者關係部分的收益發布和其他材料。此電話會議包含時效性信息,僅在 2023 年 3 月 14 日今天的現場直播時準確。GeneDx 不承擔更新或修改任何財務預測或前瞻性陳述的任何意圖或義務,除非法律要求,無論是因為新信息、未來事件還是其他原因。有了這個,我會把電話轉給凱瑟琳。

  • Katherine A. Stueland - CEO & Director

    Katherine A. Stueland - CEO & Director

  • Thank you, Tricia.

    謝謝你,特里西婭。

  • Before I dive into Q4 and full year performance, given the many recent changes in GeneDx, I'd like to provide a brief overview of our company today and our strategy going forward. First, we have a new name and a new ticker symbol. We're proud to now be GeneDx and to be trading under WGS and known to our vision of bringing the benefits of whole genome sequencing to everyone.

    在我深入探討第四季度和全年業績之前,鑑於 GeneDx 最近發生的許多變化,我想簡要概述一下我們公司的今天和我們未來的戰略。首先,我們有一個新名稱和一個新的股票代碼。我們很自豪現在成為 GeneDx 並在 WGS 下進行交易,並以我們將全基因組測序的好處帶給每個人的願景而聞名。

  • Since emerging from the NIH 2 decades ago, we have built a reputation for being the team you can count on to diagnose the most difficult to diagnose patients. Since then, we have built the industry's leading rare disease panels, exome and genome fueled by our proprietary genomic interpretation platform. This platform delivers actionable insights to clinicians with a higher and more definitive level of confidence while reducing the number of unknowns and analyzing genetic code, resulting in more diagnoses for more patients. Combining this with the Centrellis platform from Sema4, we can leverage clinical data in a way that adds critical layers to our understanding of disease, including phenotypic information, symptoms, family history and longitudinal data.

    自從 2 年前從 NIH 脫穎而出以來,我們已經建立了聲譽,成為您可以信賴的診斷最難診斷患者的團隊。從那時起,在我們專有的基因組解釋平台的推動下,我們建立了行業領先的罕見病組合、外顯子組和基因組。該平台以更高、更明確的信心水平為臨床醫生提供可操作的見解,同時減少未知數和分析遺傳密碼,從而為更多患者提供更多診斷。將其與 Sema4 的 Centrellis 平台相結合,我們可以利用臨床數據,為我們對疾病的理解增加關鍵層次,包括表型信息、症狀、家族史和縱向數據。

  • Our team has worked diligently, systematically and intelligently to execute on our mission going forward. In late 2022, we turned to a new strategic direction, exiting the reproductive health and somatic oncology testing business, which we believe will enable GeneDx to scale the profitability in 2025. Today, we announced 2022 pro forma revenue of $171 million from this go-forward business of GeneDx, and we have already guided that we expect to generate revenues between USD205 million to USD220 million in 2023.

    我們的團隊勤奮、系統和聰明地工作,以執行我們未來的使命。 2022 年底,我們轉向新的戰略方向,退出生殖健康和體細胞腫瘤學檢測業務,我們相信這將使 GeneDx 能夠在 2025 年擴大盈利能力。今天,我們宣布 2022 年預估收入為 1.71 億美元。 GeneDx 的遠期業務,我們已經指導我們預計到 2023 年將產生 2.05 億美元至 2.2 億美元的收入。

  • Last year, on a pro forma basis of the continuing GeneDx business, we delivered almost 40% growth with 40% gross margin with expectations to continue to grow in 2023 and beyond. GeneDx' ability to interpret data has been the key to unlocking the next phase of clinical genomics born from over a decade of constructing our proprietary data sets. To date, we have analyzed more than 400,000 exomes, almost 1/4 of which were analyzed in the past year, and we're doing more each and every day. This snowball effect of accumulated GeneDx data identifies more pathogenic signing that others miss, as our genomic sequencing analysis generates less uncertainty and a higher diagnostic yield compared to multi-gene panel-based test.

    去年,在持續的 GeneDx 業務的預估基礎上,我們實現了近 40% 的增長和 40% 的毛利率,預計在 2023 年及以後繼續增長。 GeneDx 解釋數據的能力一直是開啟臨床基因組學下一階段的關鍵,這一階段源於我們十多年來構建專有數據集。迄今為止,我們已經分析了超過 400,000 個外顯子組,其中近 1/4 是在去年分析的,而且我們每天都在做更多的事情。累積的 GeneDx 數據的這種滾雪球效應識別出更多其他人錯過的致病信號,因為與基於多基因組的測試相比,我們的基因組測序分析產生更少的不確定性和更高的診斷率。

  • We're in a perfect storm of commercial opportunity. Wh ile we've been building our own capabilities, there's been an expansion of clinical and practice guidelines and coverage policies across the healthcare space, which are enabling the adoption of exome sequencing for a wide range of patients. In the past 2 years, several new medical guidelines have been issued, recommending exome and genome sequencing as a first step for patients with congenital epilepsy, neurodevelopmental disorders and intellectual disabilities. These physician recommendations have included the evidence that compared with standard genetic testing, exome and genome sequencing has a higher diagnostic yield and may be more cost-effective when ordered early in the diagnostic evaluation. Our team is working to convert physician ordering patterns from multi-gene panel tests to exome sequencing and a lot of these recommendations and continued education will continue to help modify their practice.

    我們正處於一場完美的商業機會風暴中。在我們一直在構建自己的能力的同時,醫療保健領域的臨床和實踐指南以及覆蓋政策也在不斷擴展,這使得外顯子組測序能夠被廣泛的患者採用。在過去的 2 年中,已經發布了幾項新的醫學指南,建議將外顯子組和基因組測序作為先天性癲癇、神經發育障礙和智力障礙患者的第一步。這些醫生建議包含的證據表明,與標準基因檢測相比,外顯子組和基因組測序具有更高的診斷率,並且在診斷評估的早期訂購時可能更具成本效益。我們的團隊正在努力將醫生訂購模式從多基因面板測試轉換為外顯子組測序,其中許多建議和繼續教育將繼續幫助修改他們的做法。

  • In addition, you may have seen recently that both UnitedHealthcare and Cigna, 2 of the nation's largest commercial insurers have adopted favorable coverage for exome and whole genome sequencing. As a result, tens of millions of patients now have covered access to our services. So as physician adoption increases, cost of sequencing declines and the payer community further adopts clinical guidelines, we anticipate that this may contribute to significant profitable growth of our truly differentiated offering.

    此外,您最近可能已經看到美國最大的兩家商業保險公司 UnitedHealthcare 和 Cigna 都對外顯子組和全基因組測序進行了有利的覆蓋。因此,數以千萬計的患者現在已經覆蓋了我們的服務。因此,隨著醫生採用率的增加、測序成本的下降以及付款人社區進一步採用臨床指南,我們預計這可能有助於我們真正差異化產品的顯著盈利增長。

  • The opportunity for GeneDx to drive biopharma partnership revenue from our data is significant yet still at an early stage. In 2020, 55% of novel new drug and biological approvals from the FDA were orphan drugs for rare diseases. The understanding of the data we have accumulated to date allows for the potential to ultimately accelerate treatment time lines and provide the best care possible. This data can also be integral in clinical trial design, drug discovery and development for biopharma companies. We're taking a pragmatic approach to working with partners to best identify how we can work together to deliver insightful and actionable information from a variety of sources. And while we believe our information and data business may be proportionately small today, it's an important long-term strategic growth opportunity.

    GeneDx 從我們的數據中推動生物製藥合作夥伴收入的機會很大,但仍處於早期階段。 2020 年,FDA 批准的新藥和生物製品中有 55% 是罕見病孤兒藥。對我們迄今為止積累的數據的理解有可能最終加快治療時間線並提供盡可能最好的護理。這些數據也可以成為生物製藥公司臨床試驗設計、藥物發現和開發中不可或缺的一部分。我們正在採取務實的方式與合作夥伴合作,以最好地確定我們如何合作,以提供來自各種來源的有洞察力和可操作的信息。雖然我們相信我們的信息和數據業務今天可能比例較小,但這是一個重要的長期戰略增長機會。

  • We're also investing in clinical research and studies that will further demonstrate the value of exome and genome sequencing for newborns, including SeqFirst and GUARDIAN studies. These studies and others will add to the growing body of evidence that the GeneDx platform can generate significant new information and ultimately, lower the cost of treatment for difficult to diagnose rare disease and pediatric patients. With SeqFirst, we're generating clinical and health economic data in partnership with the University of Washington and Illumina. As presented at the American Society of Human Genetics Annual Meeting last October, the first phase of the study demonstrated that rapid genome sequencing in the NICU has the power to transform clinical approaches for critically ill newborns and therefore, improve overall health outcomes.

    我們還投資於臨床研究和研究,以進一步證明外顯子組和基因組測序對新生兒的價值,包括 SeqFirst 和 GUARDIAN 研究。這些研究和其他研究將增加越來越多的證據,證明 GeneDx 平台可以產生重要的新信息,並最終降低難以診斷的罕見疾病和兒科患者的治療成本。通過 SeqFirst,我們正在與華盛頓大學和 Illumina 合作生成臨床和健康經濟數據。正如去年 10 月在美國人類遺傳學學會年會上介紹的那樣,該研究的第一階段表明,NICU 中的快速基因組測序有能力改變危重新生兒的臨床方法,從而改善整體健康狀況。

  • Our partnership in the GUARDIAN genomic newborn screening study, along leading researchers at New York-Presbyterian and Columbia is designed to demonstrate household genome sequencing of newborns can deliver important diagnostic findings associated with 250 genetic conditions. Importantly, we plan to provide an update from this study at this week's American College of Medical Genetics and Genomics Annual Meeting.

    我們在 GUARDIAN 新生兒基因組篩查研究中與紐約長老會和哥倫比亞大學的主要研究人員合作,旨在證明新生兒的家庭基因組測序可以提供與 250 種遺傳病症相關的重要診斷結果。重要的是,我們計劃在本週的美國醫學遺傳學和基因組學年會上提供這項研究的更新。

  • We're confident that for additional research collaborations across a number of areas, GeneDx will continue to provide benefit to patients, physicians and caretakers. We have recently been included in several publications that highlight the critical role that our genomic insights play in the delivery of informed patient center care. It also supports the identification, discovery and development of creating therapeutics to manage and treat rare genetic diseases. We submitted nearly 1/4 of all candidate gene submissions to a public database GeneMatcher in 2022 and collaborated on 63 publications involving new disease gene associations or expansion of genotype discovery.

    我們相信,對於跨多個領域的額外研究合作,GeneDx 將繼續為患者、醫生和護理人員帶來益處。我們最近被收錄在幾篇出版物中,這些出版物強調了我們的基因組見解在提供知情的患者中心護理方面發揮的關鍵作用。它還支持識別、發現和開髮用於管理和治療罕見遺傳病的療法。我們在 2022 年向公共數據庫 GeneMatcher 提交了近 1/4 的候選基因提交,並合作發表了 63 篇涉及新疾病基因關聯或基因型發現擴展的出版物。

  • And while our commitment to rare disease continues, we have also found that our genetic data has contributed to an improved understanding of the biology of more common disorders such as sleep apnea and can be applicable to much broader segments of the general population. The genomic data from these studies will become even more powerful when combined with our Centralis platform fueled by comprehensive and definitive data sets built over the last 10 years.

    在我們繼續致力於罕見病研究的同時,我們還發現我們的基因數據有助於更好地了解睡眠呼吸暫停等更常見疾病的生物學特性,並且可以適用於更廣泛的普通人群。這些研究的基因組數據在與我們的 Centralis 平台相結合時將變得更加強大,該平台由過去 10 年建立的全面而權威的數據集提供支持。

  • We believe we have a strong thriving business with differentiated best-in-class exome and genome analysis and capabilities to evaluate the insights that this data can provide. We believe that GeneDx will be the partner of choice for patients, clinicians, healthcare systems and biopharma companies.

    我們相信我們擁有強大的蓬勃發展的業務,具有差異化的一流外顯子組和基因組分析以及評估這些數據可以提供的見解的能力。我們相信 GeneDx 將成為患者、臨床醫生、醫療保健系統和生物製藥公司的首選合作夥伴。

  • I'd like to close my remarks by extending my sincere thanks to the entire GeneDx team, without whom these achievements would not have been possible. Importantly, with the $150 million that we raised in January, we are now fully funded with the capital required to realize our mission. On behalf of our team, we're grateful to our shareholders for the opportunity to do so. With that, I'd like to pass the call over to Kevin.

    最後,我想向整個 GeneDx 團隊表示衷心的感謝,沒有他們,這些成就是不可能實現的。重要的是,憑藉我們在 1 月份籌集的 1.5 億美元資金,我們現在已經擁有實現使命所需的全部資金。我們代表我們的團隊感謝我們的股東有機會這樣做。有了這個,我想把電話轉給凱文。

  • Kevin Feeley - Senior VP of Operations & CFO

    Kevin Feeley - Senior VP of Operations & CFO

  • Thank you, Katherine. This afternoon, I'll start by discussing financial results for 2022 and then turn to financial guidance for 2023. Our strategy to target high-growth, attractive gross margin areas of genomics is working. Our pro forma financial results from continuing operations, which I will now review combines the entirety of the GeneDx Diagnostic business with the data information and revenues from the legacy Sema4 business.

    謝謝你,凱瑟琳。今天下午,我將首先討論 2022 年的財務業績,然後轉向 2023 年的財務指導。我們針對高增長、有吸引力的基因組學毛利率領域的戰略正在奏效。我現在將審查的持續運營的預估財務結果將整個 GeneDx 診斷業務與遺留 Sema4 業務的數據信息和收入相結合。

  • During the fourth quarter of 2022, pro forma revenues from continuing operations was $45.8 million compared to $34.7 million in the fourth quarter of 2021, an increase of 32%. The increase was driven primarily by growth in whole exome sequencing. Pro forma adjusted gross margin from continuing operations in the quarter was 41%, up from 35% in the fourth quarter of 2021. The expansion in margin was driven by our exome and genome testing, which have a more favorable margin profile than non-exome multi-gene panels. Whole exome sequencing accounted for 16% of total volume in this fourth quarter versus 17% in the fourth quarter of 2021.

    2022 年第四季度,持續經營業務的預計收入為 4580 萬美元,與 2021 年第四季度的 3470 萬美元相比增長了 32%。這一增長主要是由全外顯子組測序的增長推動的。本季度來自持續經營業務的備考調整後毛利率為 41%,高於 2021 年第四季度的 35%。利潤率的增長是由我們的外顯子組和基因組測試推動的,它們的利潤率高於非外顯子組多基因面板。全外顯子組測序佔第四季度總量的 16%,而 2021 年第四季度為 17%。

  • For the full year 2021, pro forma revenue from continuing operations was $171 million, up 38% from $123.7 million in 2021. Pro forma adjusted gross margin from continuing operations was 39%, up from 35% in 2021. We expect to see continued margin expansion as volume mix continues to shift towards whole exome and whole genome tests.

    2021 年全年,持續經營業務的預計收入為 1.71 億美元,比 2021 年的 1.237 億美元增長 38%。持續經營業務的預計調整後毛利率為 39%,高於 2021 年的 35%。我們預計利潤率將持續增長隨著體積組合繼續轉向全外顯子組和全基因組測試而擴展。

  • Next, I will turn to financial results for the total company, which includes costs and revenues from the now discontinued reproductive health and somatic oncology businesses. Total company revenues in the fourth quarter were $61.4 million compared to $57.8 million in the fourth quarter of 2021. This increase results from the addition of GeneDx revenues, which were not present in 2021 on a reported basis, offset by a decline in revenues from the exit of the legacy Sema4 Diagnostic business and by a onetime charge to legacy Sema4 revenues of $16 million in the quarter related to a true-up to the final settlement agreement with a payer as previously disclosed in our public filings.

    接下來,我將轉向整個公司的財務業績,其中包括現已停產的生殖健康和軀體腫瘤學業務的成本和收入。第四季度的公司總收入為 6140 萬美元,而 2021 年第四季度為 5780 萬美元。這一增長是由於 GeneDx 收入的增加,而 GeneDx 的收入在 2021 年沒有報告,但被來自 GeneDx 的收入下降所抵消退出傳統的 Sema4 診斷業務,並在本季度向傳統的 Sema4 收入一次性收取 1600 萬美元,這與我們之前在公開文件中披露的與付款人達成的最終和解協議有關。

  • Turning to gross margin. I'll be referring to our non-GAAP results. When combined with the revenues and costs from the now discontinued reproductive health and somatic oncology businesses, total company adjusted gross margin in the fourth quarter and full year 2022 was 7% and 5%, respectively. The total company adjusted gross margin was way down, of course, by the discontinued Sema4 Diagnostic business, which had materially negative gross margins in the fourth quarter.

    轉向毛利率。我將指的是我們的非 GAAP 結果。結合現已停產的生殖健康和軀體腫瘤業務的收入和成本,公司調整後的毛利率在第四季度和 2022 年全年分別為 7% 和 5%。當然,公司調整後的總毛利率大幅下降,原因是已停產的 Sema4 Diagnostic 業務在第四季度的毛利率大幅下降。

  • Total company adjusted net loss in the fourth quarter of 2022, inclusive of all activity, including the now discontinued operations, was a loss of $72.5 million compared to an adjusted net loss of $73.9 million in the same period of 2021. Within our total company unadjusted GAAP results for the fourth quarter of 2022, we recorded certain material cash and noncash charges amounting to $210.1 million related to the shutdown of legacy Sema4 reproductive health and somatic oncology and its related effects. These primarily relate to a charge of $184.1 million to write off the entirety of goodwill and the write-down write-off of inventory, fixed assets, lease right-of-use assets, along with severance charges, all related to legacy Sema4.

    2022 年第四季度公司調整後淨虧損總額為 7250 萬美元,包括所有活動,包括現已終止的業務,而 2021 年同期調整後淨虧損為 7390 萬美元。在我們未經調整的公司總額中根據 2022 年第四季度的 GAAP 業績,我們記錄了與遺留的 Sema4 生殖健康和軀體腫瘤及其相關影響關閉相關的某些重大現金和非現金費用,總計 2.101 億美元。這些主要涉及 1.841 億美元的費用,用於註銷全部商譽和庫存、固定資產、租賃使用權資產的減記註銷,以及遣散費,所有這些都與遺留的 Sema4 相關。

  • Our total cash and cash equivalents and restricted cash were $138.3 million as of December 31, 2022. In January 2023, we successfully closed a capital raise with $150 million in expected proceeds, and we believe we are fully funded to profitability in 2025. We have all the capital required to get there, and it is held at JPMorgan. The closing of approximately $7.8 million of the shares in our January equity financing is subject to shareholder approval under NASDAQ listing rules. We plan to seek shareholder approval for that in the coming weeks as well as approval for a reverse stock split in order to regain compliance with NASDAQ continuing listing requirements and an increase in the authorized shares subject to our equity incentive plan.

    截至 2022 年 12 月 31 日,我們的現金和現金等價物總額以及受限制現金為 1.383 億美元。2023 年 1 月,我們成功完成了一次融資,預期收益為 1.5 億美元,我們相信我們有足夠的資金在 2025 年實現盈利。我們有到達那裡所需的所有資金,都由摩根大通持有。根據納斯達克上市規則,我們 1 月份股權融資中約 780 萬美元的股份的交割須經股東批准。我們計劃在未來幾週內尋求股東批准,並批准反向股票分割,以重新遵守納斯達克持續上市要求,並根據我們的股權激勵計劃增加授權股份。

  • Turning to guidance. We are maintaining our previously issued 2023 guidance of USD205 million to USD220 million in revenue. Historically, we see the second and fourth quarter as our seasonally strongest. And given our recent commercial investments, we expect the second half of 2023 to outperform the first half proportionately. We expect to expand the gross margins in 2023 and beyond. We expect to use USD95 million to USD100 million of cash in 2023 for continuing operations and inclusive of servicing obligations of the exited businesses, the company's total cash burn in 2023 is expected to be in the range of USD130 million to USD145 million. As our exited businesses wind down, we are already realizing a significant decline in our cash burn rate from previous levels, which we expect to evolve towards USD20 million to USD25 million per quarter by the end of 2023. We're in a strong position today with the opportunity in front of us to drive better patient care with our technology, continued growth and expansion and ultimately be good stewards for our shareholders. And with that, I'll turn the call over to Katherine for closing remarks.

    轉向指導。我們維持之前發布的 2023 年收入 2.05 億美元至 2.2 億美元的指導方針。從歷史上看,我們認為第二和第四季度是我們的季節性最強。鑑於我們最近的商業投資,我們預計 2023 年下半年的表現將按比例好於上半年。我們預計將在 2023 年及以後擴大毛利率。我們預計 2023 年將使用 9500 萬至 1 億美元的現金用於持續經營,包括退出業務的服務義務,公司 2023 年的總現金消耗預計在 1.3 億美元至 1.45 億美元之間。隨著我們退出的業務逐漸減少,我們已經意識到我們的現金消耗率比以前的水平顯著下降,我們預計到 2023 年底每季度將達到 2000 萬美元至 2500 萬美元。我們今天處於有利地位我們有機會利用我們的技術推動更好的患者護理,持續增長和擴張,並最終成為我們股東的好管家。有了這個,我會把電話轉給凱瑟琳,讓她發表結束語。

  • Katherine A. Stueland - CEO & Director

    Katherine A. Stueland - CEO & Director

  • Thank you, Kevin. 2022 was a transformational year for GeneDx, and we're pleased with the acceleration throughout the year. We want to thank our customers, our team, our Board and our shareholders, all of whom make the work we do possible. We're excited for 2023 and beyond. I will now turn the call over to the operator for Q&A. Latif?

    謝謝你,凱文。 2022 年是 GeneDx 轉型的一年,我們對全年的加速發展感到滿意。我們要感謝我們的客戶、我們的團隊、我們的董事會和我們的股東,是他們讓我們的工作成為可能。我們對 2023 年及以後感到興奮。我現在將把電話轉給接線員進行問答。拉提夫?

  • Operator

    Operator

  • (Operator Instructions) Our first question comes from the line of Brandon Couillard of Jefferies.

    (操作員說明)我們的第一個問題來自 Jefferies 的 Brandon Couillard。

  • Brandon Couillard - Equity Analyst

    Brandon Couillard - Equity Analyst

  • Katherine, maybe just starting with the test volume mix. I mean if we look at just whole genome, whole exome plus the exome panel, it's about 24%, 25% of volume quarterly over the past year. How do you expect that to evolve in '23 just in terms of the volume mix overall?

    凱瑟琳,也許只是從測試音量組合開始。我的意思是,如果我們只看整個基因組、整個外顯子組和外顯子組,它大約佔過去一年季度數量的 24%、25%。您如何期望它在 23 年僅就整體音量組合而言會發生變化?

  • Katherine A. Stueland - CEO & Director

    Katherine A. Stueland - CEO & Director

  • Yes. So I think the key strategy that we are deploying with our commercial team really is for how many patients can we be able to convert from channels to exomes and so that is one of the key performance indicators that we're tracking on a monthly and quarterly basis. That being said, the panels that we have are incredibly important and sometimes make even more sense than an exome. So as we think about where we're going to be a year from now, we would see a proportionately higher amount of growth on the exome side of things, as we continue to really drive the messaging about the reimbursement status. We've recently learned that 4 out of 5 patients do not have to pay anything out of pocket for our exome, which is a huge message being able to take cost off the table. And with the data that we've generated that shows there's a higher diagnostic yield and fewer variants of unknown significance compared to multi-gene panels. We think that this is the right time to really more aggressively drive utilization of our best-in-class exome. So Brandon, I would say a year from now, we should be talking about a higher percentage of exomes really from an overall reimbursement standpoint as well as volume.

    是的。所以我認為我們與我們的商業團隊一起部署的關鍵戰略實際上是我們能夠將多少患者從渠道轉化為外顯子組,因此這是我們每月和每季度跟踪的關鍵績效指標之一基礎。話雖如此,我們擁有的面板非常重要,有時甚至比外顯子組更有意義。因此,當我們考慮一年後的發展方向時,我們會看到外顯子組方面的增長比例更高,因為我們繼續真正推動有關報銷狀態的消息傳遞。我們最近了解到,五分之四的患者無需為我們的外顯子組支付任何費用,這是一個能夠降低成本的重要信息。我們生成的數據表明,與多基因面板相比,診斷率更高,意義不明的變異更少。我們認為現在是真正更積極地推動我們一流外顯子組利用的正確時機。所以布蘭登,我想說一年後,我們應該真正從整體報銷的角度和數量上討論更高比例的外顯子組。

  • Brandon Couillard - Equity Analyst

    Brandon Couillard - Equity Analyst

  • Got it. Clearly, good to see United and Cigna expressing support for whole exome sequencing. Do you think those will be needle movers for your business in '23? Are those more maybe 24 catalysts? And just remind us what the guidance bets for volume growth for the year...

    知道了。顯然,很高興看到 United 和 Cigna 表示支持全外顯子組測序。您認為這些會成為您 23 年業務的推動者嗎?那些可能還有 24 種催化劑?並提醒我們今年銷量增長的指引是什麼......

  • Katherine A. Stueland - CEO & Director

    Katherine A. Stueland - CEO & Director

  • Yes. So I do think that we'll see some uplift in the second half of the year from United and Cigna. But you're right. It takes a while to operationalize contracts and to educate and really put that in the hands of all of the ordering clinicians. So it's a longer pull in terms of being able to make sure that all of that messaging reaches the ordering providers who need to hear it and then actually implement it and start ordering. So I do think that we're really pleased to see United and Cigna step up and really respond well to data that we've presented to them that shows the importance of exome over multi-gene panels. But you're right, it does take a bit longer. So I think it's best to think about it as definitely upside in '24 with maybe some lift in the second half of the year.

    是的。所以我確實認為我們會在今年下半年看到聯合和信諾的一些提升。但你是對的。實施合同並進行教育並真正將其交到所有訂購的臨床醫生手中需要一段時間。因此,就能夠確保所有這些消息傳遞到需要聽到它然後實際執行它並開始訂購的訂購提供者而言,這是一個更長的拉力。所以我確實認為我們真的很高興看到 United 和 Cigna 挺身而出,並對我們提供給他們的數據做出了很好的回應,這些數據顯示了外顯子組對多基因面板的重要性。但你是對的,確實需要更長的時間。因此,我認為最好將其視為 24 年的絕對上漲,下半年可能會有一些提升。

  • Brandon Couillard - Equity Analyst

    Brandon Couillard - Equity Analyst

  • Got you. And then last one, Katherine. On the data business, how much are you willing to spend on that kind of opportunity that's really more in the out years, I feel like, in terms of revenue generation? And will we see any validating data points on that strategy that we should look forward to in '23?

    明白了最後一個,凱瑟琳。在數據業務方面,您願意在這種機會上花費多少,我覺得,就創收而言,這種機會實際上更多?我們會在 23 年看到我們應該期待的關於該策略的任何驗證數據點嗎?

  • Katherine A. Stueland - CEO & Director

    Katherine A. Stueland - CEO & Director

  • Yes. That's a really important aspect of the business that we intend to start proving this year. But most definitely, I think it's something that we can more fully realize in '24 and beyond. In the past, I would say the legacy team is really focused on investing quite a bit of R&D in order to get deals done. So kind of building a product and investing in that product development, the data sets, really deploying our data scientists in order to even try to secure a deal. What we're doing now is we're selling what we have. So the gross margins that we're doing on biopharma deals that are coming in today are north of 70%, probably more regularly north of 80%. They are smaller deals, but we've seen some nice momentum coming in as we've really refocused on smaller biotech companies where every week of clinical development matters. They're watching their cash as acutely as we are. And so we're really happy to see some momentum and a strong pipeline from a new strategy that we put together in Q4 last year. We'd like to see continued momentum really build particularly in the second part of the year and then start working more collaboratively I would say, with some of the bigger pharma companies. I have been spending some time with them to really understand what it is that they're interested in. And I would say it's a little bit different than what we thought previously, yet we have exactly what they're looking for by way of data. So I'm really encouraged by that side of the business, but it's going to take some time. And I think in a year where our theme right now is under promised over deliver. So we want to make sure that we're sharing with investors what we have line of sight into.

    是的。這是我們今年打算開始證明的業務的一個非常重要的方面。但最肯定的是,我認為這是我們可以在 24 世紀及以後更充分地實現的東西。過去,我會說遺留團隊真的專注於投資大量研發以完成交易。構建產品並投資於產品開發、數據集,真正部署我們的數據科學家,甚至是為了達成交易。我們現在正在做的是出售我們擁有的東西。因此,我們在今天進行的生物製藥交易中的毛利率超過 70%,可能更常見的是超過 80%。它們是較小的交易,但我們已經看到了一些不錯的勢頭,因為我們真的重新關注了每週臨床開發都很重要的小型生物技術公司。他們和我們一樣敏銳地關注著他們的現金。因此,我們真的很高興看到我們在去年第四季度製定的新戰略帶來了一些勢頭和強大的渠道。我們希望看到持續的勢頭真正建立起來,尤其是在今年下半年,然後我會說,開始與一些更大的製藥公司進行更多的合作。我花了一些時間和他們在一起,真正了解他們感興趣的是什麼。我想說這與我們之前的想法有點不同,但我們通過數據準確地了解了他們正在尋找的東西.所以我真的對這方面的業務感到鼓舞,但這需要一些時間。而且我認為在我們現在的主題承諾低於交付的一年中。因此,我們希望確保我們與投資者分享我們的視野。

  • Operator

    Operator

  • Our next question comes from the line of Matt Sykes of Goldman Sachs.

    我們的下一個問題來自高盛的馬特賽克斯。

  • Matthew Carlisle Sykes - Research Analyst

    Matthew Carlisle Sykes - Research Analyst

  • Maybe just following up on Brandon's first question. regarding the volume revenue mix split. I'm just curious, Katherine, you made some comments in the prepared remarks about conversion of the multi-gene panels to whole exome whole genome. And I know you've made a lot of investments in the past year in the sales force. I think you doubled the size and you kind of gave a number in terms of sales force productivity. I'm just wondering what level of incentives and how are you encouraging the commercial team in order to convert those multi-gene panels to whole exome, whole genome. Obviously, the evidence and guideline coverage helps. But I'm just wondering in terms of how you're rolling out that strategy across the commercial team in order to get that conversion up?

    也許只是跟進布蘭登的第一個問題。關於銷量收入組合拆分。我只是好奇,凱瑟琳,你在準備好的評論中對多基因面板轉換為整個外顯子組全基因組發表了一些評論。我知道你在過去的一年裡對銷售隊伍進行了大量投資。我認為您將規模擴大了一倍,並且在銷售人員生產力方面給出了一個數字。我只是想知道什麼級別的激勵措施以及您如何鼓勵商業團隊將這些多基因面板轉化為整個外顯子組、整個基因組。顯然,證據和指南的覆蓋範圍會有所幫助。但我只是想知道您如何在整個商業團隊中推廣該策略以提高轉化率?

  • Katherine A. Stueland - CEO & Director

    Katherine A. Stueland - CEO & Director

  • Yes. So this is a really important element of the strategy here. One, when you think about who is most likely to convert, if somebody is ordering testing today and they're ordering a multi-gene panel. And so we've built a relationship with them. We are paying a higher amount for our sales reps once they convert to exome. On the non-experts who we may need to get them ordering a panel first, it's a bit of the first (inaudible) we can now get them on exome. We're paying just a normal amount, but then the rep would get additional incentives once converting that clinician into an exome. So there's a lot of work that our commercial team is doing now and throughout Q1 that we're rolling out throughout the course of Q2 and through the remainder of the year. As I mentioned earlier, we've had some really good data mining, both from a clinical data perspective, as I said earlier, data at ASHG that showed higher diagnostic yield, fewer [buses] compared to multi-gene panels, we've barely scratched the surface with getting that message out there. The 4 out of 5 patients not having it on a pocket with an exome. That has not been deployed yet. So we really have, I think, a lot of good messaging to work with backed by good data. But that's part of the reason why we're making this commercial investment now. We are expanding to include some additional territories in Q1 to be able to further support our growth with the conversion strategy, but also in turn we bring new customers on board. And then we're also working on an enhanced service model that we think will only further play into that commercial leverage that we have. So last year, we landed with $3 million of revenue per [well]. We'd like to see that continue to increase. We think exome helps with that. And the service model and efficiency really helps us, I think, take each of our commercial dollars even further.

    是的。所以這是這裡戰略的一個非常重要的元素。第一,當你考慮誰最有可能轉化時,如果有人今天訂購測試並且他們正在訂購多基因面板。因此,我們與他們建立了關係。一旦他們轉換為外顯子組,我們就會為我們的銷售代表支付更高的費用。對於我們可能需要讓他們先訂購面板的非專家,這是我們現在可以讓他們先訂購外顯子組的第一個(聽不清)。我們只支付正常金額,但一旦將該臨床醫生轉化為外顯子組,該代表將獲得額外獎勵。因此,我們的商業團隊現在和整個第一季度正在做很多工作,我們將在第二季度和今年剩餘時間推出這些工作。正如我之前提到的,我們已經進行了一些非常好的數據挖掘,無論是從臨床數據的角度來看,正如我之前所說,ASHG 的數據顯示與多基因面板相比,診斷率更高,[總線] 更少,我們已經在那裡發布該消息幾乎沒有觸及表面。 5 名患者中有 4 名沒有將其放在帶有外顯子組的口袋上。那還沒有部署。因此,我認為,我們確實有很多良好的消息傳遞,並有良好的數據支持。但這就是我們現在進行這項商業投資的部分原因。我們正在擴展以在第一季度包括一些額外的地區,以便能夠通過轉換策略進一步支持我們的增長,同時我們也會帶來新客戶。然後我們還在研究一種增強的服務模式,我們認為這種模式只會進一步發揮我們現有的商業影響力。所以去年,我們每口 [井] 獲得了 300 萬美元的收入。我們希望看到這種情況繼續增加。我們認為外顯子組對此有所幫助。我認為,服務模式和效率確實幫助我們進一步提高了我們的每一筆商業收入。

  • Matthew Carlisle Sykes - Research Analyst

    Matthew Carlisle Sykes - Research Analyst

  • Great. That's super helpful detail. And then Kevin, just on the gross margin, so I know the guidance for '23 calls for further expansion. You did 39%. I'm just talking about the legacy GeneDx. 39% just gross margin was exiting it, I think, at 41% for the fourth quarter. Like how should we think about the cadence of gross margins? And should we think of that 39% to 41% is sort of being the base to start from? Or are we kind of building from there? I'm just trying to get a sense for how gross margins contained throughout '23?

    偉大的。這是超級有用的細節。然後是凱文,就毛利率而言,所以我知道 23 年的指導要求進一步擴張。你做了 39%。我只是在談論遺留的 GeneDx。我認為第四季度的毛利率為 39%,毛利率為 41%。比如我們應該如何考慮毛利率的節奏?我們是否應該認為 39% 到 41% 是開始的基礎?或者我們是從那裡開始建設的?我只是想了解整個 23 年的毛利率如何?

  • Kevin Feeley - Senior VP of Operations & CFO

    Kevin Feeley - Senior VP of Operations & CFO

  • Yes. I think starting there with the base Q4 being the base, I think as important than what is some really interesting and impactful projects we have to reduce cost, gain efficiencies, line of sight levers that we can pull to further drive down operating costs and COGS I think as important than anything is just crystallizing that mix shift that we talked about. Our exome products today operates at 60% gross margin. And total company gross margins weighed down by the multi-gene panel side of the portfolio. And so a natural evolution would be towards that 60% mark in the intermediate term as we see exome take over the predominant share of test mix.

    是的。我認為從第 4 季度開始,我認為與一些真正有趣和有影響力的項目相比,我們必須降低成本、提高效率、我們可以拉動視線槓桿以進一步降低運營成本和 COGS 更重要我認為比任何事情都重要的是明確我們談到的混合轉變。我們今天的外顯子組產品毛利率為 60%。公司的總毛利率受到投資組合的多基因面板方面的拖累。因此,當我們看到外顯子組佔據測試組合的主要份額時,自然進化將在中期朝著 60% 的方向發展。

  • I think the guide represented of an evolution of mix that we've seen step change, leaving things like average reimbursement rate at a company level to accrete as upside to our guide and our model, if that's helpful, Matt.

    我認為該指南代表了我們已經看到的逐步變化的組合演變,讓公司層面的平均報銷率等因素成為我們指南和模型的優勢,如果這有幫助的話,馬特。

  • Matthew Carlisle Sykes - Research Analyst

    Matthew Carlisle Sykes - Research Analyst

  • Yes, that's great. And just one last quick one. Katherine, you mentioned the GUARDIAN study. Can you just remind us of the time line? I know it's just starting out, but just kind of time line, what we should be looking for in terms of (inaudible) on the way.

    是的,那太好了。最後一個快速。凱瑟琳,你提到了 GUARDIAN 書房。你能提醒我們時間線嗎?我知道這才剛剛開始,但只是一種時間線,我們應該在(聽不清)的過程中尋找什麼。

  • Katherine A. Stueland - CEO & Director

    Katherine A. Stueland - CEO & Director

  • Yes. We have one coming this week. We're really excited about it. ACMG in Utah, Dr. Wendy Chang is going to be presenting. We've got some early data that study enrolled relatively quickly, continues to enroll, but the first readout will be coming, I believe, I think on Saturday, maybe. So stay tuned for that. We'll, of course, have a press release on that. But really, really excited about the prospects for that, the receptivity of it. And importantly, some of the findings that we are able to garner just looking at our own data set at what age we were diagnosing patients comparing it to the GUARDIAN data. So stay tuned.

    是的。我們這週要來一個。我們真的很興奮。猶他州的 ACMG,Wendy Chang 博士將出席。我們有一些早期數據表明研究註冊相對較快,繼續註冊,但我相信第一個讀數將會到來,我想可能是在星期六。所以請繼續關注。當然,我們會就此發布新聞稿。但真的,真的很興奮它的前景,它的接受度。重要的是,我們僅通過查看自己診斷患者年齡的數據集,將其與 GUARDIAN 數據進行比較,就可以獲得一些發現。敬請期待。

  • Operator

    Operator

  • Our next question comes from the line of Mark Massaro, BTIG.

    我們的下一個問題來自 BTIG 的 Mark Massaro。

  • Vidyun Bais - Research Analyst

    Vidyun Bais - Research Analyst

  • This is Vivian on for Mark. So in Q4, it looks like you drove a whole exome and whole genome revenue growth of about 52%. And it looks like you drove a whole exome and whole genome volume growth of about 19% year-on-year. So just curious if you're expecting revenue growth to outpace volume growth in this segment here in '23? And if you could just speak to some of the moving parts as it relates to volume and price within this bucket?

    這是馬克的維維安。所以在第四季度,你似乎推動了全外顯子組和全基因組收入增長約 52%。看起來你推動了整個外顯子組和整個基因組體積同比增長約 19%。所以很好奇,如果您預計 23 年這裡的收入增長將超過該細分市場的銷量增長?如果你能談談與這個桶中的數量和價格相關的一些移動部件?

  • Kevin Feeley - Senior VP of Operations & CFO

    Kevin Feeley - Senior VP of Operations & CFO

  • Yes, Vivian. So I think you're right about the overall revenue as it relates to price and volume mix. While we're not providing a split of our guide between price and volume. I think important to note that throughout 2022, we saw significant improvements in our reimbursement and revenue cycle collection efforts as well as continued momentum from a policy perspective, both across commercial payers and state Medicaid programs as it relates to reimbursement for exome. We've got about 6 states right now from a Medicaid program perspective that cover exome and whole genome fairly widely. We need and expect to get closer to 50 over time than 6 where we stand today, and we'd expect to see that evolution over the next several years. Roughly 70% of commercial payers do have policy coverage for exome and genome of course, subject to certain medical criteria. And so while we expect robust revenue growth, I think it will come from a mix of volume as we activate products switch from multi-gene panels into exome. Our guide itself is not reliant on significant price accretion. But we might expect that given what seems like overwhelmingly positive wave of guidelines and recommendations coming out, which ultimately, over time, influence commercial policy coverage.

    是的,薇薇安。所以我認為你對總收入的看法是正確的,因為它與價格和數量組合有關。雖然我們沒有提供價格和數量之間的指南拆分。我認為重要的是要注意,在整個 2022 年,我們看到我們的報銷和收入周期收集工作有了顯著改善,並且從政策的角度來看,在與外顯子組報銷相關的商業付款人和州醫療補助計劃中,我們看到了持續的勢頭。從醫療補助計劃的角度來看,我們現在有大約 6 個州,這些州相當廣泛地涵蓋了外顯子組和整個基因組。隨著時間的推移,我們需要並期望從目前的 6 個接近 50 個,並且我們期望在未來幾年內看到這種演變。當然,大約 70% 的商業付款人確實有外顯子組和基因組的政策承保範圍,但要符合某些醫療標準。因此,雖然我們預計收入會強勁增長,但我認為隨著我們激活產品從多基因面板轉向外顯子組,這將來自混合數量。我們的指南本身並不依賴於顯著的價格上漲。但我們可能會預計,鑑於似乎出現了壓倒性的積極指導方針和建議浪潮,隨著時間的推移,這最終會影響商業政策的覆蓋範圍。

  • Vidyun Bais - Research Analyst

    Vidyun Bais - Research Analyst

  • Okay. Perfect. And you touched on this a little bit, but could you just remind us on what is contemplated in the guide in terms of upside from reimbursement wins. You've also spoken about a strong focus on conversion from multi-gene panels into exome. So just if you could speak to what degree of that is baked into the guidance?

    好的。完美的。你稍微談到了這一點,但你能否提醒我們指南中在報銷勝利的好處方面所考慮的內容。您還談到了將重點放在從多基因面板到外顯子組的轉化上。那麼,如果你能說出指南中融入了何種程度呢?

  • Kevin Feeley - Senior VP of Operations & CFO

    Kevin Feeley - Senior VP of Operations & CFO

  • Yes. The way I think about the guide is reliance on relatively flat pricing. So not reliant on contracted price increases or new policy, leaving those for upside. Seeing overall average total company reimbursement rates increased, but solely as a result of mix shift into higher value exome and whole genome testing.

    是的。我對指南的看法是依賴於相對平坦的定價。因此,不依賴合同價格上漲或新政策,讓那些上漲。看到總體平均總公司報銷率增加,但這僅僅是由於混合轉移到更高價值的外顯子組和全基因組測試。

  • Katherine A. Stueland - CEO & Director

    Katherine A. Stueland - CEO & Director

  • And I would just add to that. I mean, I think and it's evident in last year's numbers, too. We do sell a lot of really important panels. And it takes a while to make sure that we're able to convince clinician to convert. So it's our #1 strategy, but I do think that it's going to take some time to do that. And so I would expect we're going to continue to see a really healthy number of panels. And as I said, panels play a really, really strategic role and being able to get people who have not been ordering. So think about a pediatric neurologist. They've started ordering from us or from a competitor on the panel side of things. And they weren't ordering any genetic testing before, say, 2016, I think. So it's an important part of the mix, it's an important part of the guide. But once we get them started with that, we're confident it's better for patients, we've got the data showing a higher diagnostic yield. We've got the data showing that from a provider standpoint, fewer variants of unknown significance is really an important message to better patient care, easier for the clinician to understand and with reimbursement off the table, we think we've got what we need. But you're introducing a new strategy, and that takes time.

    我只想補充一點。我的意思是,我認為這在去年的數字中也很明顯。我們確實出售了很多非常重要的面板。並且需要一段時間才能確保我們能夠說服臨床醫生進行轉換。所以這是我們的第一戰略,但我確實認為這需要一些時間才能做到。因此,我希望我們將繼續看到非常健康的面板數量。正如我所說,小組扮演著非常非常具有戰略意義的角色,能夠吸引那些沒有訂購過的人。所以想想小兒神經科醫生。他們已經開始從我們或面板方面的競爭對手那裡訂購。我認為他們之前沒有訂購任何基因測試,比如 2016 年。所以它是組合的重要部分,它是指南的重要部分。但是一旦我們讓他們開始這樣做,我們相信這對患者更好,我們得到的數據顯示更高的診斷率。我們得到的數據表明,從提供者的角度來看,更少的未知意義的變異確實是改善患者護理的重要信息,更容易讓臨床醫生理解,並且在不考慮報銷的情況下,我們認為我們已經得到了我們需要的東西.但是您正在引入一種新策略,這需要時間。

  • Operator

    Operator

  • Our next question comes from the line of Joseph Flanagan of Cowen.

    我們的下一個問題來自 Cowen 的 Joseph Flanagan。

  • Joseph Flanagan - Associate

    Joseph Flanagan - Associate

  • This is Joe on for Max. At a recent investor conference, you stated that you believe GeneDx will be able to own about 17% of the $3 billion pediatric and rare disease TAM by the end of the year. A couple of here, but I was curious, what percent do you own today and what must get accomplished in 2023 to get to about 17% by year-end? And then kind of how are you expecting that to translate to your top line?

    這是 Joe 為 Max 做的。在最近的一次投資者會議上,您表示相信 GeneDx 到今年年底將能夠擁有價值 30 億美元的兒科和罕見病 TAM 中的約 17%。這裡有幾個,但我很好奇,你今天擁有多少百分比,到 2023 年必須完成什麼才能在年底前達到 17% 左右?然後你希望它如何轉化為你的收入?

  • Kevin Feeley - Senior VP of Operations & CFO

    Kevin Feeley - Senior VP of Operations & CFO

  • So the 17%, I'd say, is what we believe is addressable. It may not in this year, result in a shift to exome, but more so that's the percentage of patients in the market that we'd expect to have genetic testing. The amount of share we own in particular in an inpatient setting today, it's extremely low. We think that is the white space in which we can fill whereby less effective tests are either being ordered or not ordered at all from a genetic perspective. So the total share in that regard low single digits today. What I would note is roughly 80% or more of all exomes produced by commercial laboratories in the U.S. in the last 12 months were run by GeneDx. And we would note that roughly 94% of all pediatricians in the U.S. who ordered an exome ordered it from GeneDx in the last 12 months. And so we know that when some has been ordered, GeneDx who dominates that space, now it's incumbent on us to effectively make a conversion for those such tests to be first in mind diagnostic given the clinical and economic benefits rather than where it's been reserved in the past, which is, frankly, a test of last resort that's leaving patient care behind.

    所以 17%,我會說,是我們認為可以解決的問題。它可能不會在今年導致轉向外顯子組,但更多的是我們期望進行基因檢測的市場患者的百分比。我們今天在住院環境中擁有的股份數量非常低。我們認為這是我們可以填補的空白,從基因的角度來看,效率較低的測試要么被訂購,要么根本不被訂購。所以今天在這方面的總份額低個位數。我要指出的是,在過去 12 個月中,美國商業實驗室生產的所有外顯子組中大約有 80% 或更多是由 GeneDx 運行的。我們會注意到,在過去 12 個月內,大約 94% 的美國訂購外顯子組的兒科醫生都是從 GeneDx 訂購的。因此我們知道,當一些被訂購時,主導該領域的 GeneDx,現在我們有責任有效地將這些測試轉換為考慮到臨床和經濟利益而不是保留在診斷中的首要位置過去,坦率地說,這是一種最後手段的測試,將患者護理拋在腦後。

  • Katherine A. Stueland - CEO & Director

    Katherine A. Stueland - CEO & Director

  • Thank you for clarifying that. And I would just further remind people that as we think about the pediatric segment, you're right on. There's 2 segments there, one of inpatient, our rapid testing one is outpatient, which is fast, but it's not our rapid, that outpatient opportunity is the predominant focus, and it's a massive opportunity for us. So I think the inpatient is truly in its nascency. There's some really good, I would say, competitive focus in that area. So we know that it's an important element of the strategy moving forward, and that's going to be one that we have to continue to build with more and more data, including SeqFirst and other collaborations like that.

    謝謝你澄清這一點。我只想進一步提醒人們,當我們考慮兒科領域時,你是對的。那裡有兩個部分,一個是住院,一個是我們的快速測試,一個是門診,這是快速的,但不是我們的快速,門診機會是主要的焦點,這對我們來說是一個巨大的機會。所以我認為住院病人確實處於初期階段。我想說,在那個領域有一些非常好的競爭焦點。所以我們知道這是推進戰略的一個重要因素,這將是我們必須繼續使用越來越多的數據構建的一個因素,包括 SeqFirst 和其他類似的合作。

  • Joseph Flanagan - Associate

    Joseph Flanagan - Associate

  • Got it. And then part of the issued guidance was a turn to profitability in 2025. I was curious if you could just speak to a rough revenue or gross margin level that would allow GeneDx to get past that breakeven for...

    知道了。然後發布的部分指導意見是在 2025 年轉向盈利。我很好奇你是否可以說一個粗略的收入或毛利率水平,這將使 GeneDx 能夠超過...的收支平衡。

  • Kevin Feeley - Senior VP of Operations & CFO

    Kevin Feeley - Senior VP of Operations & CFO

  • Yes. I mean we haven't provided specifics on the out years per se. But I think in large part, it comes with confidence that the base level product in which we aim to make our predominant product that being exome and whole genome operates at 60% today, we know we have room to improve that. And so with mix evolution and then further improvements to drive exome, then further upside to the base diagnostics business is building that relatively nascent data business that we have today. The data business today represented about 5% of total company revenue from continuing operations in 2022, we expect it to stay at about that level of proportionate total company revenue in '23. But the deals that we've been signing recently, all operating in that 70% to 90% margin range. So as we see the data business start to make meaningful contributions to our business, it will help us evolve towards a level of profitability in early 2025.

    是的。我的意思是我們沒有提供過去幾年本身的細節。但我認為,在很大程度上,它充滿信心,我們旨在製造我們的主要產品(外顯子組和全基因組)的基礎水平產品今天以 60% 的速度運行,我們知道我們有改進的空間。因此,隨著混合進化,然後進一步改進以驅動外顯子組,基礎診斷業務的進一步上升正在建立我們今天擁有的相對新生的數據業務。今天的數據業務約佔 2022 年公司持續運營總收入的 5%,我們預計它在 23 年將保持在公司總收入的比例水平左右。但我們最近簽署的交易,都在 70% 到 90% 的利潤率範圍內運作。因此,當我們看到數據業務開始為我們的業務做出有意義的貢獻時,它將幫助我們在 2025 年初實現盈利水平。

  • Operator

    Operator

  • Thank you. I would now like to turn the conference back to Katherine Stueland for closing remarks. Madam?

    謝謝。我現在想把會議轉回 Katherine Stueland 作閉幕詞。女士?

  • Katherine A. Stueland - CEO & Director

    Katherine A. Stueland - CEO & Director

  • Excellent. Well, thank you all. We appreciate all of the good questions. Excited to spend this year, providing important updates on our progress and continuing to educate investors about the important role that we are playing in diagnosis of disease, opening up access to it, having a healthy business and really staying focused on driving the kind of volume that is good for patients, but also good for our company. And we look forward to talking to you at a future conference. Thank you.

    出色的。嗯,謝謝大家。我們感謝所有的好問題。很高興今年花錢,提供有關我們進展的重要更新,並繼續教育投資者我們在疾病診斷、開放獲取疾病、擁有健康的業務以及真正專注於推動這種交易量方面發揮的重要作用這對患者有好處,對我們公司也有好處。我們期待在未來的會議上與您交談。謝謝。

  • Operator

    Operator

  • So this concludes today's conference call. Thank you for participating. You may now disconnect.

    今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。