Fulgent Genetics Inc (FLGT) 2024 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Hello and welcome to the Fulgent Genetics Q2 2024 Conference Call and Webcast. (Operator Instructions) As a reminder, this conference is being recorded.

    您好,歡迎來到 Fulgent Genetics 2024 年第二季電話會議和網路廣播。(操作員指示)謹此提醒,本次會議正在錄製中。

  • It's now my pleasure to turn the conference over to Melanie Solomon, Investor Relations. Please go ahead, Melanie.

    現在我很高興將會議交給投資者關係部門的梅蘭妮·所羅門 (Melanie Solomon)。請繼續,梅蘭妮。

  • Melanie Solomon - IR Contact Officer

    Melanie Solomon - IR Contact Officer

  • Thank you, Kevin. Good morning and welcome to the Fulgent second-quarter of 2024 financial results conference call. On the call today are Ming Hsieh, Chief Executive Officer; Paul Kim, Chief Financial Officer; and Brandon Perthuis, Chief Commercial Officer.

    謝謝你,凱文。早上好,歡迎參加 Fulgent 2024 年第二季財務業績電話會議。今天參加電話會議的是執行長謝明 (Ming Hsieh);保羅‧金 (Paul Kim),財務長;和首席商務官 Brandon Perthuis。

  • The company's press release discussing the financial results is available on the Investor Relations section of the company's website, www.fulgentgenetics.com. A replay of this call will be available shortly after the call concludes on the Invest Relations section of the company's website.

    該公司討論財務表現的新聞稿可在該公司網站 www.fulgentgenics.com 的投資者關係部分查閱。電話會議結束後不久,公司網站的投資關係部分將提供該電話會議的重播。

  • Management's prepared remarks and answers to your questions on today's call will contain forward-looking statements. These forward-looking statements represent management's estimates based on current views and assumptions, which may prove to be incorrect. As a result, matters discussed in any forward-looking statements are subject to risks, uncertainties and changes in circumstances that may cause actual results to differ from those described in the forward-looking statements.

    管理層在今天的電話會議上準備好的評論和對您問題的回答將包含前瞻性陳述。這些前瞻性陳述代表了管理階層基於當前觀點和假設的估計,這些估計可能被證明是不正確的。因此,任何前瞻性陳述中討論的事項都受到風險、不確定性和情況變化的影響,可能導致實際結果與前瞻性陳述中描述的結果不同。

  • The company assumes no obligation to update any of the forward-looking statements that may make today to reflect actual results or changes in expectations. Listeners should not rely on any forward-looking statements as predictions of future events and should looking to management's remarks today with the understanding that actual events, including the company's actual future results, may be materially different than what is described in or implied by these forward-looking statements.

    該公司不承擔更新今天可能做出的任何前瞻性陳述以反映實際結果或預期變化的義務。聽眾不應依賴任何前瞻性陳述作為對未來事件的預測,而應關注管理層今天的言論,並理解實際事件(包括公司未來的實際結果)可能與這些前瞻性陳述中描述或暗示的內容存在重大差異看起來的陳述。

  • Please review the more detailed discussions related to these forward-looking statements, including the discussions of some of the risk factors that may cause results to differ from those described in the forward-looking statements contained in the company's filings with the Securities and Exchange Commission, including the previously filed 10-K for the year ended December 31, 2023, and subsequently filed reports, which are available on the company's Investor Relations website.

    請查看與這些前瞻性陳述相關的更詳細討論,包括對可能導致結果與公司向美國證券交易委員會提交的文件中前瞻性陳述中描述的結果不同的一些風險因素的討論,包括先前提交的截至2023年12 月31 日的年度10-K 以及隨後提交的報告,這些報告可在公司的投資者關係網站上查看。

  • Management's prepared remarks including discussions of earnings and earnings per share, contain financial measures not prepared in accordance with accounting principles generally accepted in the United States, or GAAP. Management has prepared these non-GAAP financial measures because it believes they may be useful to investors for various reasons, but these measures should not be viewed as a substitute for or superior to the company's financial results prepared in accordance with GAAP.

    管理層準備的評論(包括對收益和每股收益的討論)所包含的財務指標並未按照美國普遍接受的會計原則(GAAP)制定。管理層準備了這些非公認會計原則財務指標,因為它認為它們可能出於各種原因對投資者有用,但這些指標不應被視為替代或優於公司根據公認會計原則準備的財務表現。

  • Please see the company's press release discussing its financial results for the second quarter of 2024 for more information, including the description of how the company calculates non-GAAP income or loss, earnings or loss per share, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating profit or loss and margin and adjusted EBITDA, and a reconciliation of these financial measures to income or loss, earnings or loss per share, and operating margin, the most directly comparable GAAP financial measures.

    請參閱該公司討論 2024 年第二季度財務業績的新聞稿,了解更多信息,包括公司如何計算非 GAAP 收入或虧損、每股收益或虧損、非 GAAP 毛利潤、非 GAAP 的說明毛利率、非GAAP 營業利潤或虧損和利潤率以及調整後的EBITDA,以及這些財務指標與收入或虧損、每股收益或虧損以及營業利潤率(最直接可比較的GAAP 財務指標)的調整表。

  • With that, I'd now like to turn the call over to Ming.

    說到這裡,我現在想把電話轉給小明。

  • Ming Hsieh - Chairman of the Board, President, Chief Executive Officer

    Ming Hsieh - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Melanie. Good morning and thank you for joining our call today. I will start with some comments on the second quarter and our two business lines. Then Brandon will review our product and go to market updates for our laboratory service business in the second quarter. And Paul will conclude with the financial and outlook before we take your questions.

    謝謝你,梅蘭妮。早安,感謝您今天加入我們的電話會議。我將首先對第二季和我們的兩條業務線發表一些評論。然後布蘭登將在第二季度審查我們的產品並為我們的實驗室服務業務進行市場更新。在我們回答你們的問題之前,保羅將總結財務和前景。

  • We are pleased with our results in second quarter. With $71 million of total revenue, we recognized $841,000 of revenue on previously built COVID-19 tests. Excluding COVID-19 revenue, second quarter core revenue of $70.2 million was driven by momentum in precision diagnosis, particularly reproductive health and oncology. We were pleased with the growth in all three areas of our laboratory service business this quarter, and we've seen good momentum ahead as we continue to invest in reproductive health testing and seeing the benefit of those investments.

    我們對第二季的業績感到滿意。總收入為 7,100 萬美元,我們透過先前建構的 COVID-19 測試確認了 841,000 美元的收入。不包括 COVID-19 收入,第二季核心收入為 7,020 萬美元,這是由精準診斷(尤其是生殖健康和腫瘤學)的勢頭推動的。我們對本季實驗室服務業務所有三個領域的成長感到高興,並且隨著我們繼續投資生殖健康檢測並看到這些投資的好處,我們看到了未來的良好勢頭。

  • We have reached a very important milestone in consolidating the labs acquired as a part of the informed diagnosis transaction. With our new 96,000 square foot lab facility in Coppell, Texas, we believe we'll have an opportunity to triple a capacity, fueling the potential future growth and expansion. Brandon will talk more about this.

    在整合作為知情診斷交易一部分而獲得的實驗室方面,我們已經達到了一個非常重要的里程碑。憑藉我們位於德克薩斯州科佩爾的 96,000 平方英尺的新實驗室設施,我們相信我們將有機會將產能增加兩倍,從而推動未來潛在的成長和擴張。布蘭登將更多地談論這一點。

  • In our therapeutic development business, we presented Phase 1 clinical data using our lead therapeutic development candidate FID-007, to treat head and neck cancer. At American Society for Clinical Oncology or ASCO annual meeting in June 2024. Of 11 head and neck, squamous cell carcinoma or HNSCC, available patients with weekly dose level from 50 milligram per square meter to 160 milligram per square meter. 5% or 45% had a partial response, and 7% or 27% had a stable disease by this.

    在我們的治療開發業務中,我們展示了使用我們的主要治療開發候選藥物 FID-007 治療頭頸癌的 1 期臨床數據。2024 年 6 月在美國臨床腫瘤學會或 ASCO 年會。對11名頭頸、鱗狀細胞癌或HNSCC患者,可用的每週劑量值為每平方公尺50毫克至每平方公尺160毫克。 5%或45%的人有部分緩解,7%或27%的人疾病穩定。

  • Three out of five HNSCC patients with a partial response had previously been treated with taxanes. The duration of a follow-up meeting range is four months. No high-grade neuropathy has been noted. FID-007 demonstrated preliminary evidence of anti-tumor activity in heavily pre-treated HNSCC patients across different primary tumor sites, with an overall response rate of 45%.

    獲得部分緩解的五分之三的 HNSCC 患者之前曾接受過紫杉烷類治療。後續會議的持續時間為四個月。尚未發現嚴重神經病變。FID-007 在不同原發腫瘤部位的接受過大量治療的 HNSCC 患者中顯示出抗腫瘤活性的初步證據,整體緩解率為 45%。

  • As a result, we initiated a Phase 2 clinical trial of FID-007 in combination with the [cetuximab] in patients with HNSCC in January 2024, and the enrollment began in the second quarter. So far we have enrolled and those the first three patients in this trial, we expect to enroll approximately 40 patients in various side to -- with enrollment expect to compete in early 2026. We currently estimate total patient clinical trial costs for the Phase 2 to be around $10 million.

    因此,我們於2024年1月啟動了FID-007合併[西妥昔單抗]治療HNSCC患者的2期臨床試驗,並於第二季開始入組。到目前為止,我們已經入組了該試驗的前 3 名患者,我們預計將在各個方面招募約 40 名患者,預計將在 2026 年初進行入組競賽。我們目前估計第 2 階段的患者臨床試驗總成本約為 1000 萬美元。

  • We continue to advance our second drug candidate, FID-022, a nano encapsulated SN38 in pre-clinical studies toward an investigational new drug application by end this year. While FID-022 has shown superior efficacy of Irinotecan in various xenograft models including colon, bile duct, ovarian, and pancreatic cancers in our preclinical study, no significant unexpected toxicity were observed in both rat and the monkey GLP toxicity studies.

    我們繼續推進我們的第二個候選藥物 FID-022,這是一種奈米封裝的 SN38 臨床前研究,爭取在今年年底前進行新藥研究應用。雖然在我們的臨床前研究中,FID-022 在各種異種移植模型(包括結腸癌、膽管癌、卵巢癌和胰腺癌)中顯示出伊立替康的卓越功效,但在大鼠和猴子GLP 毒性研究中沒有觀察到顯著的意外毒性。

  • In addition, we also made a significant advancement in development of antibody drug conjugate using our novel patterned linker and the payload platform technology.

    此外,我們也利用新型圖案化接頭和有效負載平台技術在抗體藥物偶聯物的開發方面取得了重大進展。

  • Our ADC has shown better efficacy overall over different tumors with a broad range of targeted antigen equation levels than some of the best ADC benchmark and market in the pre-clinical studies. In meanwhile, ADC with novel target using our novel platform technology are also being prepared with the goal of generating leading candidate for clinical trials.

    與臨床前研究中一些最好的 ADC 基準和市場相比,我們的 ADC 對不同腫瘤表現出更好的整體療效,具有廣泛的靶向抗原方程式水平。同時,使用我們新穎平台技術的具有新標靶的ADC也在準備中,目標是產生用於臨床試驗的領先候選藥物。

  • As a reminder, all our drug candidates were formulated with our novel nanoencapsulation technology which includes over 30 issued active patents and active patent applications and target of 30 platform designed to improve therapeutic windows and pharmacokinetics profile for both new and existing cancer drugs.

    需要提醒的是,我們所有的候選藥物均採用我們的新型奈米封裝技術配製而成,其中包括30 多項已發布的有效專利和有效專利申請,以及30 個旨在改善新藥和現有癌症藥物的治療窗口和藥物動力學特徵的平台。

  • Overall, we believe we have a good strategy with both our core laboratory services business and our therapeutic development business. We are seeing momentum in our core business which will be believed to continue to grow, strengthening our business model and fuel our therapeutic initiative.

    總的來說,我們相信我們的核心實驗室服務業務和治療開發業務都有良好的策略。我們看到我們的核心業務勢頭強勁,相信它將繼續成長,加強我們的商業模式並推動我們的治療計劃。

  • We continue to maintain a strong balance sheet to execute our strategy. I would like to thank our employees, partners, stakeholders for your hard work and loyalty in a very good second quarter for our business. We look forward to continue growth in the second half of 2024.

    我們繼續保持強勁的資產負債表來執行我們的策略。我要感謝我們的員工、合作夥伴、利害關係人的辛勤工作和忠誠度,為我們的業務帶來了非常好的第二季。我們期待 2024 年下半年繼續成長。

  • I will now turn the call over to Brandon Perthuis, our Chief Commercial Officer, to talk more about our laboratory service business results during the second quarter. Brandon?

    我現在將把電話轉給我們的首席商務官 Brandon Perthuis,更多地討論我們第二季度的實驗室服務業務表現。布蘭登?

  • Brandon Perthuis - Chief Commercial Officer

    Brandon Perthuis - Chief Commercial Officer

  • Thanks, Ming. As a reminder, our laboratory service business includes precision diagnostics, anatomic pathology, and biopharma services. These three represent our core revenue streams and do not include COVID-19 tests.

    謝謝,明。提醒一下,我們的實驗室服務業務包括精密診斷、解剖病理學和生物製藥服務。這三個代表我們的核心收入來源,不包括 COVID-19 測試。

  • And we had another very strong quarter led by precision diagnostics with all three areas showing strength. This is the first time we have seen all three areas post quarter-over-quarter growth since 2022. In the past few quarters, we have experienced some headwinds in anatomic pathology and biopharma services, but we are seeing the investments we made in those areas begin to pay off. I'll talk more about each of those momentarily.

    我們在精準診斷的帶領下又度過了一個非常強勁的季度,所有三個領域都表現出了強勁的實力。這是自 2022 年以來我們首次看到所有三個領域均實現環比增長。在過去的幾個季度中,我們在解剖病理學和生物製藥服務方面遇到了一些阻力,但我們看到我們在這些領域的投資開始得到回報。我稍後會詳細討論其中的每一個。

  • Circling back to precision diagnostics, it was up $5.7 million, or 15% quarter-over-quarter, and $11.2 million or 35% year-over-year. The tremendous strength has been led by reproductive health testing, including Beacon expanded carrier screening. Beacon continues to be a bright spot for Fulgent. We have to have significant market share, establish strong B2B relationships, and continue to have a sales pipeline that gives us confidence and continued growth.

    回到精準診斷,該季度成長 570 萬美元,季增 15%,年增 1,120 萬美元,成長 35%。生殖健康檢測引領了這一巨大力量,其中包括 Beacon 擴大的攜帶者篩檢。Beacon 仍然是 Fulgent 的亮點。我們必須擁有顯著的市場份額,建立強大的 B2B 關係,並繼續擁有給我們信心和持續成長的銷售管道。

  • The laboratory continues to perform exceptionally well, even with the record volume we are seeing. On average, our turnaround time has been 11 days, which is fantastic and a true testament to the power of our technology platform. To scale this rapidly and continue to provide rapid turnaround time is not trivial. We've also been able to give our clients the flexibility to custom tailor the gene panel to their specifications.

    儘管我們看到了創紀錄的數量,但實驗室仍然表現出色。平均而言,我們的周轉時間為 11 天,這非常出色,也真正證明了我們技術平台的強大功能。要快速擴展並繼續提供快速的周轉時間並非易事。我們還能夠為客戶提供根據其規格定制基因組的靈活性。

  • In addition, our strong engineering capabilities have allowed us to rapidly interface with client-side EMRs, allowing for orders and reports to be delivered electronically. Beacon will continue to be a focus for Fulgent as we now find ourselves as one of the leading providers of expanded care screening services.

    此外,我們強大的工程能力使我們能夠快速與客戶端電子病歷接口,從而以電子方式交付訂單和報告。Beacon 將繼續成為 Fulgent 的焦點,因為我們現在已成為擴展護理篩檢服務的領先提供者之一。

  • Staying on reproductive health, last quarter we announced we have launched a non-invasive prenatal test, or NIPT, for the first time, a test we have branded NOVA. NOVA is the first NIPT to include common aneuploidies, microdeletions, and monogenic conditions caused by de novo point mutations. We continue to make good progress with our go-to-market strategy and anticipate seeing additional progress in the coming quarters.

    在生殖健康方面,上個季度我們宣布首次推出非侵入性產前檢測(NIPT),該檢測我們將其命名為 NOVA。NOVA 是第一個涵蓋常見非整倍體、微缺失和從頭點突變引起的單基因狀況的 NIPT。我們的上市策略持續取得良好進展,並預計在未來幾季會取得更多進展。

  • As we have mentioned, we expect volume to be low for some time as we bring this novel test to market. However, we believe over time, clinicians will see the value of this new NIPT methodology. I wanted to provide a quick update on our oncology portfolio. We recently gained MolDX approval for our liquid biopsy assay for high-stage solid tumors, complementing our previously approved solid tumor tissue and heme NGS assays.

    正如我們所提到的,當我們將這種新穎的測試推向市場時,我們預計銷量將在一段時間內處於較低水平。然而,我們相信隨著時間的推移,臨床醫生將會看到這種新的 NIPT 方法的價值。我想快速介紹一下我們的腫瘤學產品組合。我們最近獲得了 MolDX 批准用於高階段實體瘤的液體活檢檢測,補充了我們先前批准的實體瘤組織和血紅素 NGS 檢測。

  • Our liquid biopsy offering is a comprehensive test including over 500 genes, which detects tumor mutation burden, microsatellite instability, indels, and copy number alterations in addition to single nucleotide variants.

    我們的液體活檢產品是一項全面的測試,包括 500 多個基因,除了單核苷酸變異之外,還可檢測腫瘤突變負荷、微衛星不穩定性、插入缺失和拷貝數改變。

  • The coverage rate is approximately $2,840 and is retroactive back to September 2023. This is just one more piece of the puzzle, helping complete a near one-stop shop for oncologists. Over time, the focus will be to continue to build out the commercial team and capture market share, leaning on this one-stop shop offering and excellent quality, Q&S rates and turnaround time.

    承保範圍約為 2,840 美元,可追溯至 2023 年 9 月。這只是拼圖的另一個部分,幫助完成腫瘤學家的近乎一站式服務。隨著時間的推移,重點將是繼續建立商業團隊並佔領市場份額,依靠一站式服務和卓越的品質、Q&S 率和周轉時間。

  • Turning to anatomic pathology, we are pleased to see this area return to growth, albeit small. Anatomic pathology has seen multiple quarters of headwinds related to our integration of the acquisition of informed diagnostics and some macro factors, but we now see this area stabilized.

    談到解剖病理學,我們很高興看到該區域恢復生長,儘管規模很小。解剖病理學已經經歷了多個季度的阻力,這些阻力與我們整合獲取知情診斷和一些宏觀因素有關,但我們現在看到這個領域已經穩定下來。

  • And more importantly, the sales team is closing meaningful new accounts and the pipeline is strong. This is a result of a revamped go-to-market strategy and improved sales team and continued laboratory performance as it relates to quality and turnaround time.

    更重要的是,銷售團隊正在關閉有意義的新客戶,而且通路很強大。這是改進的上市策略、改進的銷售團隊以及持續的實驗室績效的結果,因為它與品質和周轉時間有關。

  • Also during the quarter, we relocated the operation to our newly purchased building at Coppell, Texas, and consolidated our New York laboratory. This was not trivial, yet executed very well, a special thanks to all the team members who worked so hard on this. We believe this investment will provide long-term advantages related to capacity, efficiency, and cost.

    同樣在本季度,我們將業務遷至德克薩斯州科佩爾新購買的大樓,並整合了我們的紐約實驗室。這不是一件小事,但執行得非常好,特別感謝所有為此付出努力的團隊成員。我們相信這項投資將帶來產能、效率和成本的長期優勢。

  • Biopharma services also return to growth in the second quarter. As we have mentioned in previous calls, we continue to expand our technical capabilities, allowing us to address a larger market. We have invested an additional sales headcount in this area and are building a robust sales funnel.

    生物製藥服務也在第二季度恢復成長。正如我們在先前的電話會議中所提到的,我們不斷擴展我們的技術能力,使我們能夠應對更大的市場。我們在這一領域投入了額外的銷售人員,並正在建立一個強大的銷售管道。

  • This market continues to expand as Biopharmaline's more on multi-omics studies for their drug development and we believe we are in a good position to continue to partner up on these studies. Nonetheless, this is an area we still expect results to vary from period-to-period due to the nature of the project and a lengthy sales cycle.

    隨著 Biopharmaline 更多地進行藥物開發的多組學研究,這個市場繼續擴大,我們相信我們處於有利地位,可以繼續在這些研究上合作。儘管如此,由於專案的性質和漫長的銷售週期,我們仍然預期該領域的結果會因時期而異。

  • There were some questions around the new FDA regulations on lab-developed tests at the time of our last call, and we have gained some clarification, although many questions remain, at a high level, we interpret the new regulations as a potentially positive catalyst for Fulgent.

    在我們上次通話時,人們對FDA 關於實驗室開發測試的新法規存在一些疑問,我們已經得到了一些澄清,儘管仍然存在許多問題,但在較高層面上,我們將新法規解釋為潛在的積極催化劑晶。

  • Many of our tests are New York State approved, and we have over 20,000 tests launched on our menu before the May 6, 2024 publication date, which is the operative date for the purposes of the currently marketed test enforcement discretion policy.

    我們的許多測試都獲得了紐約州的批准,並且在2024 年5 月6 日發布日期之前,我們的菜單上推出了超過20,000 項測試,該日期是當前市場上測試執行自由裁量權政策的實施日期。

  • As long as they're not modified, it appears these tests will likely only need to meet device regulatory requirements that become applicable at Stage 1, Stage 2, and Stage 3 of the FDA's phase-out timeline, and we don't presently expect material disruptions to our service offerings.

    只要不進行修改,這些測試似乎只需要滿足 FDA 逐步淘汰時間表的第一階段、第二階段和第三階段適用的設備監管要求,我們目前預計不會我們的服務產品受到重大干擾。

  • Stage 1 includes FDA medical device reporting, which will require laboratories to report certain device-related adverse events and product problems to FDA within a specific timeframe. Stage 1 also requires labs to maintain compliant files for each test they offer and to report any corrections or removals to the agency.

    第一階段包括 FDA 醫療器材報告,這將要求實驗室在特定時間內向 FDA 報告某些與器材相關的不良事件和產品問題。第一階段還要求實驗室維護其提供的每項測試的合規文件,並向機構報告任何更正或刪除。

  • Stage 2 requires each laboratory to be registered with the FDA and to list their commercial tests with the agency. It also phases in device labeling requirements and certain other compliance rules. Stage 3 applies certain other quality system regulations to laboratories and their tests with the specific requirements depending in large part on whether a currently marketed test is approved by New York State or not.

    第二階段要求每個實驗室在 FDA 註冊,並向該機構列出其商業測試。它還分階段提出了設備標籤要求和某些其他合規規則。第三階段將某些其他品質系統法規應用於實驗室及其測試,具體要求在很大程度上取決於目前上市的測試是否獲得紐約州批准。

  • These new regulations may make it more difficult for new labs to open or new tests to be launched at existing laboratories, potentially creating a competitive moat for our company. However, there is a federal lawsuit pending against the FDA, which argues that the agency did not have the authority to announce the LDT final rule.

    這些新規定可能會使開設新實驗室或在現有實驗室啟動新測試變得更加困難,從而可能為我們公司創造一條競爭護城河。然而,針對 FDA 的聯邦訴訟正在懸而未決,該訴訟稱該機構無權宣布 LDT 最終規則。

  • The plaintiffs in that case are seeking to vacate FDA's issuance of the final rule. The outcome of that lawsuit is highly uncertain, and it may change the legal and regulatory landscape for clinical laboratories.

    該案的原告正在尋求撤銷 FDA 發布的最終規則。該訴訟的結果高度不確定,它可能會改變臨床實驗室的法律和監管模式。

  • Accordingly, this is all very new and much could change. Ultimately, the effect of these regulations may not be as we currently expect. So we will continue to monitor the FDA's implementation of these new regulations and the ongoing litigation that is attempting to invalidate the final rule.

    因此,這一切都是非常新的,並且可能會發生很多變化。最終,這些規定的效果可能不會像我們目前預期的那樣。因此,我們將繼續關注 FDA 對這些新法規的實施情況以及正在進行的試圖使最終規則無效的訴訟。

  • In closing, we are very pleased with our progress so far this year and optimistic about the upcoming quarters. We believe with our large diverse product offering and a powerful technology platform, we are primed to continue to build on our success.

    最後,我們對今年迄今為止的進展感到非常滿意,並對未來幾季感到樂觀。我們相信,憑藉我們豐富多樣的產品和強大的技術平台,我們已準備好繼續取得成功。

  • I'll now turn the call over to Paul Kim, our Chief Financial Officer. Paul?

    我現在將把電話轉給我們的財務長 Paul Kim。保羅?

  • Paul Kim - Chief Financial Officer

    Paul Kim - Chief Financial Officer

  • Thank you, Brandon. Revenue in the second quarter of 2024 totaled $71 million compared to $67.9 million in the second quarter of 2023. $841,000 came from COVID-19 testing in Q2, which was not part of our guidance. Revenue from our core business totaled $70.2 million.

    謝謝你,布蘭登。2024 年第二季的營收總計 7,100 萬美元,而 2023 年第二季的營收為 6,790 萬美元。我們的核心業務收入總計 7,020 萬美元。

  • GAAP gross margin was 37% and on a non-GAAP basis was 40%. Gross margins continue to improve year-over-year showing the benefit of our continued efficiencies and streamlining of our business. Total GAAP operating expenses were $45.4 million for the second quarter, compared to $43.9 million in the first quarter of 2024, primarily related to higher R&D spend.

    GAAP 毛利率為 37%,非 GAAP 毛利率為 40%。毛利率繼續逐年提高,這顯示我們持續提高效率和精簡業務所帶來的好處。第二季 GAAP 營運支出總額為 4,540 萬美元,而 2024 年第一季為 4,390 萬美元,主要與研發支出增加有關。

  • Non-GAAP operating expenses totaled $33.8 million, compared to $32.4 million in the first quarter of 2024. Non-GAAP operating margins increased approximately 5 percentage-point sequentially to minus 7.4%, primarily due to higher revenue and gross margin in Q2.

    非 GAAP 營運費用總計 3,380 萬美元,而 2024 年第一季為 3,240 萬美元。非 GAAP 營運利潤率較上季成長約 5 個百分點,達到負 7.4%,主要是由於第二季營收和毛利率上升。

  • Adjusted EBITDA loss for the second quarter was $727,000 compared to a loss of $2.7 million in the second quarter of 2023. On a non-GAAP basis and excluding stock-based compensation expenses and intangible asset amortization, income for the quarter was $4.7 million, or a positive $0.15 per share based on $30 million weighted average fully diluted shares outstanding.

    第二季調整後 EBITDA 虧損為 72.7 萬美元,而 2023 年第二季虧損 270 萬美元。以非公認會計準則計算,不包括股票薪酬費用和無形資產攤銷,本季收入為 470 萬美元,即根據 3000 萬美元加權平均完全稀釋已發行股票計算,每股收益為正 0.15 美元。

  • Turning to the balance sheet, we ended the second quarter with approximately $838 million in cash, cash equivalents and marketable securities. Cash used in the period included investment and building improvements in lab equipment for our Coppell Lab, which Brandon mentioned. We relocated our Texas lab in the second quarter.

    轉向資產負債表,第二季末我們擁有約 8.38 億美元的現金、現金等價物和有價證券。布蘭登提到,這段時期使用的現金包括對科佩爾實驗室的實驗室設備進行投資和建造改進。我們在第二季度搬遷了德克薩斯州實驗室。

  • Now moving on to our guidance. We're reiterating our revenue outlook for 2024 with minimal revenues from COVID-19 testing expected, we're guiding to core revenues, which is total laboratory services revenue for the company without COVID-19 testing revenue. We continue to expect a total core revenue to be approximately $280 million for 2024 representing core growth of 7% year-over-year. There's no revenues from our therapeutics development business anticipated in our 2024 guidance.

    現在繼續我們的指導。我們重申 2024 年的收入前景,預計來自 COVID-19 測試的收入極少,我們的指導是核心收入,即沒有 COVID-19 測試收入的公司實驗室服務總收入。我們仍預期 2024 年核心總營收約為 2.8 億美元,核心年增 7%。我們的 2024 年指導中預計沒有來自治療開發業務的收入。

  • Turning to expected margins for 2024, excluding COVID-19 revenue and stock-based compensation, we expect non-GAAP gross margins to continue to be around the high 30% range that we saw in Q2 and reach our target of 40% by the end of the year. We expect to see slightly lower non-GAAP operating margins in the quarters ahead as we further invest resources to grow our business, an operating margin of approximately minus 16% for the year.

    談到 2024 年的預期利潤率,不包括 COVID-19 收入和股票薪酬,我們預計非 GAAP 毛利率將繼續保持在第二季度 30% 的高位區間,並在年底達到 40% 的目標今年的。隨著我們進一步投資資源來發展業務,我們預計未來幾季的非公認會計準則營業利潤率將略有下降,全年營業利潤率約為-16%。

  • We remain focused on managing our spend and continue to believe that our foundational technology platform supports a strong margin profile longer term. We continue to expect associated cash burn for a therapeutics development business to be about $15 million to $17 million this year, which is contemplated in our EPS and cash guidance.

    我們仍然專注於管理我們的支出,並繼續相信我們的基礎技術平台可以支援長期強勁的利潤狀況。我們仍預計今年治療藥物開發業務的相關現金消耗約為 1500 萬至 1700 萬美元,這在我們的 EPS 和現金指導中有所考慮。

  • Based on the lower spend we achieved in the first-half of the year and a more favorable tax rate forecast for the full-year, we're lowering our expected GAAP EPS loss to approximately $1.95 per share, excluding any one-time charges using a 30 million average share count.

    基於我們在今年上半年實現的較低支出以及對全年更有利的稅率預測,我們將預期 GAAP 每股收益損失降低至每股約 1.95 美元,不包括使用平均股數為 3000 萬股。

  • Utilizing a non-GAAP tax provision, an average share count of 30 million, we're lowering our expected full-year 2024 net non-GAAP loss to approximately $0.30 per share for shareholders, excluding stock-based compensation and amortization of intangible assets as well as any one-time charges.

    利用非 GAAP 稅收規定(平均股數為 3000 萬股),我們將股東預期的 2024 年全年非 GAAP 淨虧損降低至每股約 0.30 美元,不包括基於股票的薪酬和無形資產攤銷:以及任何一次性費用。

  • Finally, our cash position remains strong, excluding any stock purchases or other expenditures outside the ordinary course, which could include M&A or real property purchases. We would anticipate ending 2024 with approximately $800 million of cash, cash equivalents and investments in marketable securities.

    最後,我們的現金狀況仍然強勁,不包括任何股票購買或正常過程之外的其他支出,其中可能包括併購或房地產購買。我們預計到 2024 年底將擁有約 8 億美元的現金、現金等價物和有價證券投資。

  • Overall, we see strength in our core business, which has grown organically, and through strategic acquisitions and see good momentum ahead.

    總體而言,我們看到了我們的核心業務的實力,該業務透過策略性收購實現了有機成長,並看到了良好的未來勢頭。

  • Thank you for joining our call. Operator, now you may open it up for questions.

    感謝您加入我們的通話。接線員,現在您可以打開它提問。

  • Operator

    Operator

  • Certainly, we'll now be conducting a question-and-answer session. (Operator Instructions)

    當然,我們現在將進行問答環節。(操作員說明)

  • David Westenberg, Piper Sandler.

    大衛‧韋斯特伯格,派珀‧桑德勒。

  • David Westenberg - Analyst

    David Westenberg - Analyst

  • Hi. No, thank you for taking the question and great job in the quarter. I think this one would be for Paul. I know, I think it's really obvious right now that your cash management has been fairly terrific over the course of through all of your different acquisitions. So with an $800 million cash balance and your kind of like proven cash discipline. Is there any thought to capital allocation going back to M&A strategy? Or do you think you have maybe too many irons in the fire right now with all the different businesses and moving into more oncology tests and reproductive health and all the clinical trials coming up?

    你好。不,感謝您提出問題以及本季的出色工作。我想這應該是給保羅的。我知道,我認為現在很明顯,在所有不同的收購過程中,你們的現金管理相當出色。因此,擁有 8 億美元的現金餘額和經過驗證的現金紀律。資本配置有沒有回歸併購策略的想法?或者您認為您現在可能有太多的事情要做,涉及所有不同的業務,並轉向更多的腫瘤學測試和生殖健康以及即將進行的所有臨床試驗?

  • I think our cash balance is certainly sufficient to do the things that we want to do to address a wider market that we can with our capabilities. When we take a look at the efficiencies in our business, we see it combined overall with the companies that we have purchased over the last couple of years. As you remember, in 2022, our core revenues was approximately $181 million. In 2023, the core revenues were $262 million. In 2024, as of today's call, we're reiterating $280 million of our core revenues.

    我認為我們的現金餘額肯定足以做我們想做的事情,以利用我們的能力來應對更廣泛的市場。當我們審視我們業務的效率時,我們發現它與我們過去幾年收購的公司的整體效率相結合。如您所知,2022 年我們的核心收入約為 1.81 億美元。2023年,核心收入為2.62億美元。截至今天的電話會議,我們重申 2024 年核心收入將達到 2.8 億美元。

  • When we take a look at our overall business, the momentum for our core has seen a very, very nice growth. But I think the other thing that we're very, very excited about is the improvement that we see in our overall operations, particularly our gross margins. If you look at the gross margins for the business, excluding COVID, the gross margins, excluding stock-based compensation in the first quarter of 2023 was approximately 28%. When within six quarters for Q2 of 2024, even if you take out the COVID, our gross margins are 39.4%, that is over 11 whole points of improvements that we have in the gross margins.

    當我們審視我們的整體業務時,我們的核心業務成長勢頭非常非常好。但我認為我們非常非常興奮的另一件事是我們整體營運的改善,特別是毛利率。如果你看看該業務的毛利率(不包括新冠疫情),2023 年第一季的毛利率(不包括股票薪酬)約為 28%。在 2024 年第二季的六個季度內,即使排除新冠疫情,我們的毛利率也為 39.4%,這比我們的毛利率提高了 11 個百分點。

  • And then you get into the operating expenses. The operating expenses have been more favorable than we have anticipated. Now, some of that was due to better collection experience that we had within our regular business, as well as COVID. But yes, you are correct. The overall efficiencies in our business, the efficiencies that we had with integrating our acquisitions, and cash management has been much better than we have anticipated.

    然後你就可以考慮營運費用了。營運費用比我們預期的要有利。現在,部分原因是我們在常規業務以及新冠疫情期間擁有更好的催收經驗。但是,是的,你是對的。我們業務的整體效率、整合收購的效率以及現金管理都比我們預期的要好得多。

  • Okay, great.

    好的,太好了。

  • Brandon Perthuis - Chief Commercial Officer

    Brandon Perthuis - Chief Commercial Officer

  • Maybe, David if I just --

    也許,大衛,如果我只是--

  • David Westenberg - Analyst

    David Westenberg - Analyst

  • I'm sorry.

    對不起。

  • Brandon Perthuis - Chief Commercial Officer

    Brandon Perthuis - Chief Commercial Officer

  • Sorry, David. It's Brandon. I just want to address the point. No, we don't have too many irons in the fire, to answer your question. However, we're going to be very careful with our acquisitions going forward. But the management team consistently evaluates opportunities for M&A. We've done two M&As thus far, and both have worked quite well. That's not always the case with companies. If we do a third or a fourth, we want to make sure it's something we can make work. But we don't have too many irons in the fire, and we consistently evaluate opportunities.

    對不起,大衛。這是布蘭登。我只想解決這個問題。不,我們沒有太多的熨斗來回答你的問題。然而,我們將非常謹慎地對待未來的收購。但管理團隊始終如一地評估併購機會。到目前為止,我們已經完成了兩次併購,而且都進展順利。公司的情況並非總是如此。如果我們做了第三個或第四個,我們要確保它是我們能夠實現的。但我們並沒有太多的熨斗,我們始終如一地評估機會。

  • David Westenberg - Analyst

    David Westenberg - Analyst

  • Great, great. No thank you, Brandon. That was a great clarity there. I'll stick with you in terms of the questions here, Brandon. Just in terms of the reproductive health business, that's a growing opportunity there. Can you talk about some of the differentiation you have in the NIPT test? We talked about [Sinimo] a couple weeks ago, but I think it's pretty important to reiterate this.

    太棒了,太棒了。不,謝謝你,布蘭登。那裡非常清晰。布蘭登,我會繼續回答你的問題。僅就生殖健康業務而言,這是一個不斷成長的機會。您能談談 NIPT 測試的一些差異嗎?幾週前我們討論了 [Sinimo],但我認為重申這一點非常重要。

  • And if there any guideline expectations, obviously not in the guide, but what's the latest there? And would you indeed benefit from both expanded carrier screening, ACOG recommendation and in addition microdeletions, particularly [22q], if that comes out. And just in terms of timelines for when that could come out. Thank you.

    如果有任何指導性期望,顯然不在指南中,但最新的是什麼?如果出現的話,您確實會受益於擴大的攜帶者篩檢、ACOG 建議以及微缺失,特別是 [22q]。只是就何時發布的時間表而言。謝謝。

  • Brandon Perthuis - Chief Commercial Officer

    Brandon Perthuis - Chief Commercial Officer

  • Yeah. Thanks for the question. We also are hearing rumors of expanded ACOG guidelines going forward for expanded carrier screening. Certainly, that would benefit the industry. clinically, we're there. If you look -- especially on the infertility side of the business, expanded care screening is standard-of-care. That is what doctors are ordering for their patients going through infertility treatments.

    是的。謝謝你的提問。我們還聽到有關擴大 ACOG 指南以擴大攜帶者篩檢的傳言。當然,這將使該行業受益。臨床上,我們就在那裡。如果你仔細觀察,特別是在不孕症方面,擴大護理篩檢是護理標準。這是醫生為接受不孕症治療的患者開的處方。

  • So it would be great to see the guidelines become more aligned with practice today. Most the biggest benefit there being payers often fall in line with the guidelines. So we'll continue to monitor that. I know it's being worked on. And I think it will be positive for the industry as it relates to expanded carrier screening.

    因此,很高興看到這些指南變得更加符合當今的實踐。大多數最大的福利支付者通常都符合指導方針。所以我們將繼續關注這一情況。我知道它正在研究中。我認為這對整個行業來說是積極的,因為它涉及擴大攜帶者篩檢。

  • In terms of our NIPT test, the main differentiator there is being able to screen for de novo point mutations. Most NIPTs out there are screening for any employee as well as microdeletions and so micro duplications, but don't include de novo point mutations for these monogenic conditions.

    就我們的 NIPT 測試而言,主要的區別在於能夠篩選從頭點突變。大多數 NIPT 都會篩檢任何員工以及微缺失和微重複,但不包括這些單基因疾病的從頭點突變。

  • And these monogenic conditions are quite serious they do cause severe disability. They are relatively common when you group them together. So we think this novel approach over time could be something clinicians really see as added value when they think about picking an NIPT partner.

    這些單基因疾病相當嚴重,它們確實會導致嚴重的殘疾。當你把它們組合在一起時,它們是相對常見的。因此,我們認為,隨著時間的推移,這種新穎的方法可能會成為臨床醫生在考慮選擇 NIPT 合作夥伴時真正看到的附加價值。

  • David Westenberg - Analyst

    David Westenberg - Analyst

  • Great. And then just because I haven't asked one from Ming, I'll ask one for you. Just in terms of the head and neck opportunity, you said in the call, you have begun to start to enrollment. When would enrollment end? And then how long would the study be? And then can you help us size the opportunity of head and neck cancer, particularly for FID-007? Thank you.

    偉大的。然後因為我還沒向Ming 索取一份,我就替你要一份。就頭部和頸部機會而言,您在電話中說,您已經開始開始招生。報名什麼時候結束?那麼研究需要多長時間?那麼您能否幫助我們評估頭頸癌的機會,特別是 FID-007?謝謝。

  • Ming Hsieh - Chairman of the Board, President, Chief Executive Officer

    Ming Hsieh - Chairman of the Board, President, Chief Executive Officer

  • Okay. Thank you, David. We are excited with the performance or results of our Phase I study of FID-007. So we are doing the second phase trial for the second-line head and neck cancer patients. So the expected enrollment to be in the early 2026. And then definitely based on the results, we'll probably move into the -- next is Phase III or if the result is really impressive, which is around above 50% of response grid, it might have a chance to apply for the fast track of the FDA approval process.

    好的。謝謝你,大衛。我們對 FID-007 第一階段研究的表現或結果感到興奮。所以我們正在針對二線頭頸癌患者進行二期試驗。因此預計入學時間為 2026 年初。然後肯定根據結果,我們可能會進入——接下來是第三階段,或者如果結果真的令人印象深刻,大約超過響應網格的 50%,它可能有機會申請快速通道FDA 審批流程。

  • So giving for that's the opportunity for the head and neck cancer patient. Currently, the first-line treatment for head and neck cancer patient is using the immunotherapy using the KEYTRUDA for the treatment. Typically, the immunotherapy, the first line failed there was no real standard second-line treatment. We see the opportunity and try to get into this market for the second line, the treatment.

    因此,給予頭頸癌患者一個機會。目前,頭頸癌患者的第一線治療是採用免疫療法,並使用KEYTRUDA進行治療。通常,免疫療法一線治療失敗,沒有真正標準的二線治療。我們看到了機會,並嘗試進入這個市場進行二線治療。

  • There's over 50,000 patients of head and neck cancer in the U.S. alone. And that definitely globally is much, much bigger in terms of the cancer patients. So we are excited about the opportunity, and we do see a tremendous potential for us to grow in that area. This is only for the FID-007 definitely, we're pushing for a next drug will be into the market into the clinical study in 2024 -- '25, I'm sorry.

    光是在美國就有超過 5 萬名頭頸癌患者。就癌症患者而言,全球範圍內的數字肯定要大得多。因此,我們對這個機會感到興奮,並且確實看到了我們在該領域發展的巨大潛力。這肯定只是針對 FID-007,我們正在推動下一種藥物將在 2024 年進入市場並進行臨床研究——抱歉,25 年。

  • David Westenberg - Analyst

    David Westenberg - Analyst

  • Thank you, guys, that's it for me.

    謝謝你們,夥計們,這就是我的了。

  • Operator

    Operator

  • Dan Leonard, UBS.

    丹‧倫納德,瑞銀集團。

  • Dan Leonard - Analyst

    Dan Leonard - Analyst

  • Thank you. My first question, what changed on the expense side?

    謝謝。我的第一個問題,費用方面發生了什麼變化?

  • Paul Kim - Chief Financial Officer

    Paul Kim - Chief Financial Officer

  • Yeah. What changed on the expense side. That's a good. You're talking about operating expenses. Is that correct?

    是的。費用方面發生了什麼變化。那很好。你說的是營運費用。這是正確的嗎?

  • Dan Leonard - Analyst

    Dan Leonard - Analyst

  • Yeah. That was the big change in your guidance. I'm curious what would functionally happened there?

    是的。這是您的指導的重大變化。我很好奇那裡會發生什麼功能?

  • Paul Kim - Chief Financial Officer

    Paul Kim - Chief Financial Officer

  • Yes. The biggest change that we had was, we had a lower G&A cost than what we anticipated, meaning that we were anticipating the G&A expense for the second quarter to be approximately $25 million to $26 million. But we had favorable collections from what we had previously reserved for. So that reduced our expenses.

    是的。我們最大的變化是,我們的 G&A 成本低於我們的預期,這意味著我們預計第二季的 G&A 費用約為 2500 萬至 2600 萬美元。但我們從之前預訂的收藏中得到了不錯的收藏。這樣就減少了我們的開支。

  • Dan Leonard - Analyst

    Dan Leonard - Analyst

  • So it was a change on the reserve side, as opposed to head count or anything like that?

    那麼這是儲備方面的變化,而不是人數或類似的變化?

  • Paul Kim - Chief Financial Officer

    Paul Kim - Chief Financial Officer

  • That's right. I mean the head count and our operating plan, it was about what we anticipated. But we had a reduction in G&A due to better collections. And then the reason -- yes, and the reason why we narrowed our EPS was due to that.

    這是正確的。我的意思是人員數量和我們的營運計劃,這與我們的預期相符。但由於館藏的改善,我們的一般行政費用減少。然後是原因——是的,我們縮小每股收益的原因就是這個。

  • And then to a lesser extent, we had some tax benefits and credits come through the provision. But overlaying right, the overall condition of the company, we've had better gross margins, as I indicated before, our revenues were slightly higher and then just the efficiencies that we have in running our business.

    然後,在較小程度上,我們透過該條款獲得了一些稅收優惠和抵免。但是,從公司的整體狀況來看,我們的毛利率更高,正如我之前指出的,我們的收入略高,然後是我們經營業務的效率。

  • Dan Leonard - Analyst

    Dan Leonard - Analyst

  • Understood. And then, Brandon, I appreciate the thorough discussion on the FDA regulation of LDTs. But you did flag the uncertainty there. And I'm curious, how does the uncertainty around implementation of that regulation impact how you manage your business?

    明白了。然後,Brandon,我很欣賞關於 FDA 對 LDT 監管的深入討論。但你確實指出了那裡的不確定性。我很好奇,該法規實施的不確定性如何影響您管理業務的方式?

  • Brandon Perthuis - Chief Commercial Officer

    Brandon Perthuis - Chief Commercial Officer

  • Well, it's a good question. Thank you. And I think for the most part, it doesn't. We believe whichever way they decide to go, we're in a good position especially benefiting from the tremendous size of our test menu. We have over 20,000 tests on our menu, which would predate the new regulations.

    嗯,這是一個好問題。謝謝。我認為在大多數情況下,事實並非如此。我們相信,無論他們決定走哪條路,我們都處於有利地位,特別是受益於我們龐大的測試菜單。我們的菜單上有超過 20,000 項測試,這些測試早於新規定。

  • And in addition, a lot of our tests anyway are New York state approved. So should they continue down their current path. We think we're in a good position. And I mentioned on the call that maybe creates a bit of a moat around our business. If the lawsuit is successful and all this goes away, then we're back to where we were a few months ago running our business. So I think we're in a good position either way.

    此外,我們的許多測試無論如何都得到了紐約州的批准。他們應該繼續沿著目前的道路前進嗎?我們認為我們處於有利地位。我在電話中提到,這可能會在我們的業務周圍形成一些護城河。如果訴訟成功並且所有這些都消失了,那麼我們就會回到幾個月前的經營狀態。所以我認為無論怎樣我們都處於有利位置。

  • Dan Leonard - Analyst

    Dan Leonard - Analyst

  • Appreciate that. And then just final question. Curious how the market share picture is evolving since we last caught up one of your big competitors was acquired or at least the acquisition was finalized. And I'm curious if you've seen anything different in the market?

    很欣賞這一點。然後是最後一個問題。很好奇自從我們上次報道你們的一個大競爭對手被收購或至少收購完成以來,市場份額的情況是如何演變的。我很好奇您是否在市場上看到什麼不同的東西?

  • Brandon Perthuis - Chief Commercial Officer

    Brandon Perthuis - Chief Commercial Officer

  • Yes, good question. A little bit, not a lot. The competitor, you said, was acquired. So there was minimal, I think, disruption to their business there. I do think there was some and we did pick up some market share, but it wasn't like the previous event where we picked up very significant market share in Reproductive Health testing. But certainly, there was some instability there and some market shake up, but not to a large degree.

    是的,好問題。一點點,不多。你說的競爭對手被收購了。所以我認為他們在那裡的業務受到的干擾很小。我確實認為有一些,我們確實獲得了一些市場份額,但這與之前的活動不同,我們在生殖健康測試方面獲得了非常重要的市場份額。但可以肯定的是,那裡存在一些不穩定因素,市場也出現了一些波動,但幅度並不大。

  • Dan Leonard - Analyst

    Dan Leonard - Analyst

  • Got it. Thank you.

    知道了。謝謝。

  • Operator

    Operator

  • Andrew Cooper, Raymond James.

    安德魯庫珀,雷蒙德詹姆斯。

  • Andrew Cooper - Analyst

    Andrew Cooper - Analyst

  • Hey, everybody. Thanks for the time. Maybe just first, I don't know if Brandon, maybe you're the right one to answer this. But just on NIPT, I mean, talk to us about sort of what's happening now in terms of starting to detail clinicians and kind of how you see that process playing out? When we should be thinking about potential ramp potential further appreciation of some of the differentiation given you said it is going to take some education to get there. So just would love your thoughts on what that pathway can look like?

    嘿,大家。謝謝你的時間。也許首先,我不知道布蘭登是否是回答這個問題的正確人選。但就 NIPT 而言,我的意思是,請跟我們談談現在正在發生的事情,開始詳細介紹臨床醫生,以及您如何看待過程的進行?當我們應該考慮潛在的成長潛力時,考慮到您所說的需要一些教育才能實現這一點,因此可能會進一步欣賞一些差異化。那麼,我想知道您對這條途徑的看法嗎?

  • Brandon Perthuis - Chief Commercial Officer

    Brandon Perthuis - Chief Commercial Officer

  • Yes. Thank you, Andrew. I think it's going to take some time. This is the first novel NIPT product to hit the market in some time. So you're spot on. It is going to take some significant physician and clinician education. I do think there is a powerful message behind it. The de novo point mutation for the monogenic conditions really does add a lot of clinical value, but it is going to require a lot of clinician education.

    是的。謝謝你,安德魯。我認為這需要一些時間。這是第一個在一段時間以來上市的新型 NIPT 產品。所以你是對的。這將需要一些重要的醫生和臨床醫生教育。我確實認為這背後有一個強而有力的訊息。單基因疾病的從頭點突變確實增加了許多臨床價值,但這需要大量的臨床醫生教育。

  • Right now, we have a pretty small sales team focused on that area. So I would expect some more meaningful volume, probably not until 2025, as we really said, focused on the education part as well as doing some additional publication and validation studies and some expanded indications. So I'm thinking more of a meaningful volume in 2025.

    目前,我們有一個非常小的銷售團隊專注於該領域。因此,我預計會出現一些更有意義的捲,可能要到 2025 年才會出現,正如我們所說,重點關注教育部分,並進行一些額外的出版和驗證研究以及一些擴展的適應症。所以我想在 2025 年出版一本更有意義的書。

  • Andrew Cooper - Analyst

    Andrew Cooper - Analyst

  • Okay, helpful. Maybe shifting a little bit, just anatomic pathology. You talked about winning new accounts and some real positive things there. The business isn't necessarily growing materially though. So -- maybe just give us a sense, are these new account wins more recent? Or what's the moderating factor where maybe you're seeing some customers go out the door on the other side or some volume transition one way or the other to keep that business from growing a little bit better?

    好的,有幫助。也許會發生一點變化,只是解剖病理學。您談到了贏得新客戶以及一些真正積極的事情。不過,該業務不一定會大幅成長。那麼,也許只是讓我們了解一下,這些新帳戶的獲勝是最近發生的嗎?或者,您可能會看到一些客戶從另一邊走出去,或者某些數量以某種方式轉變,以阻止業務成長得更好,那麼調節因素是什麼?

  • Brandon Perthuis - Chief Commercial Officer

    Brandon Perthuis - Chief Commercial Officer

  • Yes. Well, look, it's been going the wrong direction for some time, which we've been working on. Some of that was macro factors, some of that was around contracted rates and reimbursement and other situation. But either way, the business is going the wrong way. We've addressed most of those. And I think the biggest thing we've done is make sure we adhere to our turnaround time, at the lab, which we've done.

    是的。好吧,看,一段時間以來它一直在朝著錯誤的方向發展,但我們一直在努力解決這個問題。其中一些是宏觀因素,有些是圍繞合約費率和報銷等情況。但無論哪種方式,企業都走錯路了。我們已經解決了其中的大部分問題。我認為我們所做的最重要的事情就是確保我們遵守實驗室的周轉時間,我們已經做到了。

  • Even during the move, which we did in the second quarter, we still maintained our turnaround time. We've also revamped the sales team. We've restructured the sales team. We've restructured comp plans, to more align with our corporate objectives. So we've tackled this at all different angles, and we're seeing it pay off. I know this quarter wasn't much growth, but it was some. So we think the business has been stabilized.

    即使在我們第二季進行的搬遷期間,我們仍然保持了周轉時間。我們也重組了銷售團隊。我們重組了銷售團隊。我們重組了薪酬計劃,以更符合我們的企業目標。因此,我們從各個不同的角度解決了這個問題,並且我們看到了它的回報。我知道本季成長不多,但還是有一些成長。所以我們認為業務已經穩定。

  • And when we look at the sales pipeline, in the recent wins, the very recent wins, the sales team is finding bigger deals. So I think the back half of the year for AP should continue to have some really good momentum.

    當我們查看銷售管道時,在最近的勝利中,最近的勝利中,銷售團隊正在尋找更大的交易。所以我認為美聯社今年下半年應該會繼續保持一些非常好的勢頭。

  • Andrew Cooper - Analyst

    Andrew Cooper - Analyst

  • Perfect. That's super helpful. And then maybe for Paul, we've seen you guys active in terms of buybacks in some recent quarters. So just would love maybe any thoughts on that given you're not executing on M&A, having a great cash balance and doing well from that cash management side of things, maybe how you think about potential deployment of that capital, whether to do more repurchases again or elsewhere?

    完美的。這非常有幫助。也許對保羅來說,我們看到你們在最近幾季的回購方面很活躍。因此,考慮到您沒有執行併購,擁有大量現金餘額並且在現金管理方面做得很好,也許您對此有何想法,也許您如何考慮該資本的潛在部署,是否進行更多回購再次還是其他地方?

  • Paul Kim - Chief Financial Officer

    Paul Kim - Chief Financial Officer

  • Yeah. So as you as you remember, we have a $250 million stock buyback program. To date, we bought back about $100 million, so there's $150 million left. We do see buyback as one of the options that we have for the usage of our cash. There are times where we can buy and there are times where we can't buy. We've shown also in the past that we deployed that cash in making two significant acquisitions CSI and InformDx. And I think the operational results show that we have had tremendous success in integrating and creating value from those acquisitions, which are being reflective in our overall results. And we believe the best way to return share -- return value to shareholders and an ROI is to continue to invest in this market and to expand our business.

    是的。正如您所記得的,我們有一項 2.5 億美元的股票回購計劃。到目前為止,我們回購了大約 1 億美元,所以還剩下 1.5 億美元。我們確實將回購視為我們使用現金的選擇之一。我們有能買的時候,也有不能買的時候。我們過去也曾展示過,我們利用這些現金進行了兩項重大收購:CSI 和 InformDx。我認為營運結果表明,我們在整合這些收購併創造價值方面取得了巨大成功,這反映在我們的整體業績中。我們相信回報份額(回報股東價值和投資回報率)的最佳方法是繼續投資這個市場並擴大我們的業務。

  • Ming Hsieh - Chairman of the Board, President, Chief Executive Officer

    Ming Hsieh - Chairman of the Board, President, Chief Executive Officer

  • Yes. I think Dan, adding the point for Paul mentioned, I think we are actively looking for the target for M&A. But taking a look at what we did for those two transactions, Inform Diagnosis and CSI laboratory services, not only we spend money for the acquisition, but also we need to spend the time and reinvestment to integrate those business.

    是的。我認為丹補充了保羅提到的觀點,我認為我們正在積極尋找併購目標。但看看我們在 Inform Diagnosis 和 CSI 實驗室服務這兩項交易中所做的事情,我們不僅花錢收購,而且還需要花費時間和再投資來整合這些業務。

  • I did a rough calculation. Besides, we spent about close to $220 million to buy those two business. We also invested more than $60 million of cash and try to integrate and streamline those business. We do see those acquisitions making this as very strategic move, which lead us the capability to grow our Precision Diagnostics business, which is we show the results without those insurance contracts, we're not able to get us into the position to be a major player in the Reproductive Health area.

    我粗略地算了一下。此外,我們還花了近 2.2 億美元購買了這兩家公司。我們還投資了超過 6000 萬美元的現金,並嘗試整合和簡化這些業務。我們確實認為這些收購使其成為非常具有戰略意義的舉措,這使我們有能力發展我們的精密診斷業務,即我們在沒有這些保險合約的情況下展示結果,我們無法使我們成為主要的公司生殖健康領域的參與者。

  • We continue to execute our strategy. We are looking for the old opportunities for the M&A and as well as our internal development. So that's the way we will spend our cash.

    我們繼續執行我們的戰略。我們正在尋找併購和內部發展的舊機會。這就是我們花錢的方式。

  • Andrew Cooper - Analyst

    Andrew Cooper - Analyst

  • Great. I'll stop there. Thanks again.

    偉大的。我就到此為止。再次感謝。

  • Brandon Perthuis - Chief Commercial Officer

    Brandon Perthuis - Chief Commercial Officer

  • Thanks, Andrew.

    謝謝,安德魯。

  • Operator

    Operator

  • Thank you. We reached the end of our question-and-answer session. And ladies and gentlemen, that does conclude today's teleconference and webcast. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.

    謝謝。我們的問答環節結束了。女士們、先生們,今天的電話會議和網路廣播到此結束。此時您可以斷開線路並度過美好的一天。我們感謝您今天的參與。