Exagen Inc (XGN) 2024 Q2 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Greetings. Welcome to the Exagen Inc., second quarter 2024 earnings call. (Operator Instructions) Please note that this conference is being recorded.

    問候。歡迎參加 Exagen Inc. 2024 年第二季財報電話會議。(操作員說明)請注意,本次會議正在錄製中。

  • At this time, I'll turn the conference over to Ryan Douglas with Investor Relations. Ryan, you may now begin.

    這次,我將把會議交給投資人關係部門的瑞安‧道格拉斯 (Ryan Douglas)。瑞安,你現在可以開始了。

  • Ryan Douglas - Investor Relations

    Ryan Douglas - Investor Relations

  • Good morning and thank you for joining us. Earlier today, Exagen Inc., released financial results for the quarter ended June 30, 2024. The release is currently available on the company's website at www.exagen.com. John Aballi, President and Chief Executive Officer, will host this morning's call.

    早安,感謝您加入我們。今天早些時候,Exagen Inc. 發布了截至 2024 年 6 月 30 日的季度財務表現。該版本目前可在公司網站 www.exagen.com 上取得。總裁兼執行長約翰·阿巴利 (John Aballi) 將主持今天上午的電話會議。

  • Before we get started, I would like to remind everyone that management will be making statements during this call that include 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.

    在我們開始之前,我想提醒大家,管理層將在本次電話會議中發表聲明,其中包括聯邦證券法含義內的前瞻性聲明,這些聲明是根據《私人證券訴訟改革法案》的安全港條款制定的1995 年。

  • Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements, including, without limitation, statements regarding our business strategy and future financial and operating performance, including guidance, potential profitability our current and future product offerings and reimbursement and coverage are based upon current estimates and various assumptions.

    本次電話會議中包含的任何非歷史事實陳述的陳述均應被視為前瞻性陳述。所有前瞻性陳述,包括但不限於有關我們的業務策略以及未來財務和經營業績的陳述,包括指導、我們當前和未來產品的潛在盈利能力以及報銷和覆蓋範圍,均基於當前的估計和各種假設。

  • These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission, including our Form 10-K for the year ended December 31, 2023, our Form 10-Q for the quarter ended June 30, 2024, and any subsequent filings.

    這些陳述涉及重大風險和不確定性,可能導致實際結果與這些前瞻性陳述預期或暗示的結果有重大差異。因此,您不應過度依賴這些陳述。有關與我們業務相關的風險和不確定性的清單和描述,請參閱我們向美國證券交易委員會提交的文件,包括截至2023 年12 月31 日的年度10-K 表格、截至6 月的季度的10 -Q 表格2024 年 3 月 30 日以及任何後續文件。

  • In addition, some of the information discussed today include non-GAAP financial measures such as adjusted EBITDA that have not been calculated in accordance with generally accepted accounting principles in the United States or GAAP. These non-GAAP items should be used in addition to and not as a substitute for any GAAP results. We believe these metrics provide useful supplemental information in assessing our revenue and operating performance.

    此外,今天討論的一些資訊包括非 GAAP 財務指標,例如未按照美國公認會計原則或 GAAP 計算的調整後 EBITDA。這些非 GAAP 項目應作為任何 GAAP 結果的補充,而不是取代任何 GAAP 結果。我們相信這些指標為評估我們的收入和營運績效提供了有用的補充資訊。

  • Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of our earnings release issued earlier today, which has been posted to the Investor Relations page of the company's website.

    這些非公認會計原則財務指標與最直接可比較的公認會計原則財務指標的調節表顯示在我們今天早些時候發布的收益報告末尾的表格中,該報告已發佈在公司網站的投資者關係頁面上。

  • The information provided in this conference call speaks only to the live broadcast today, August 5, 2024. Exagen disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections or other forward-looking statements, whether because of new information, future events or otherwise.

    本次電話會議中提供的資訊僅適用於今天(2024 年 8 月 5 日)的直播。除法律要求外,Exagen 不承擔任何更新或修改任何資訊、財務預測或其他前瞻性聲明的意圖或義務,無論是由於新資訊、未來事件或其他原因。

  • I will now turn the call over to John Aballi, President and CEO of Exagen.

    我現在將把電話轉給 Exagen 總裁兼執行長約翰·阿巴利 (John Aballi)。

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Thanks, Ryan, and good morning to everyone joining the call. Today, I'll provide updates on the progress we've made over the last few months and continuing to reshape Exagen for long-term profitable growth, including details on our second quarter financial performance. The results of this quarter are really starting to demonstrate a track record of performance and progress towards our goals.

    謝謝瑞安,大家早安。今天,我將提供有關我們過去幾個月的進展以及繼續重塑 Exagen 以實現長期盈利增長的最新進展,包括我們第二季度財務業績的詳細信息。本季的結果確實開始展示我們的業績記錄和實現目標的進展。

  • Our results over the first half of the year and specifically the trajectory over the last 18 months, has shown that we can grow and expand our business while simultaneously pursuing profitability. To that end, this quarter, we delivered a $1.6 million adjusted EBITDA loss, 53% improvement year over year, and the best quarterly financial performance in Exagen's history. And with the first half 2024 adjusted EBITDA loss of only $3.6 million, we continue to make major strides on both top and bottom line performance.

    我們上半年的業績,特別是過去 18 個月的軌跡表明,我們可以在追求盈利的同時發展和擴大業務。為此,本季我們實現了 160 萬美元的調整後 EBITDA 損失,年增 53%,並實現了 Exagen 歷史上最好的季度財務業績。2024 年上半年調整後 EBITDA 損失僅 360 萬美元,我們持續在營收和利潤方面取得重大進展。

  • As I look back at where we were just before I joined Exagen, our progress is truly impressive. In 2022, we delivered $45.6 million in revenue, but our adjusted EBITDA loss was $40 million and accelerating. Our gross margins for that year were just under 47%.

    當我回顧加入 Exagen 之前我們的處境時,我們的進步確實令人印象深刻。2022 年,我們實現了 4,560 萬美元的收入,但調整後的 EBITDA 損失為 4,000 萬美元,並且仍在加速。那一年我們的毛利率略低於 47%。

  • Sitting here today, we have reshaped Exagen into an exciting business, which is on pace to achieve profitability. We've grown our quarterly revenue almost 30% from average 2022 levels. And this year, we now expect our full-year adjusted EBITDA loss to be on par with what we used to lose every quarter, a 70% improvement.

    今天坐在這裡,我們已將 Exagen 重塑為一項令人興奮的業務,並且正在穩步實現盈利。我們的季度營收較 2022 年平均值成長了近 30%。今年,我們預計全年調整後 EBITDA 損失將與過去每季的損失持平,改善 70%。

  • Our margins have expanded 13 points over this time, and we are on the cusp of further margin expansion with enhanced IP protection on our core product, all while revamping our R&D pipeline and deleveraging our organization. I'm incredibly proud of the team for this transformation and astounded by the progress we've made in such a short period.

    在此期間,我們的利潤率擴大了 13 個百分點,並且我們正處於進一步擴大利潤率的風口浪尖,同時加強對我們核心產品的智慧財產權保護,同時改善我們的研發管道並降低我們組織的槓桿率。我為團隊的這一轉變感到無比自豪,並對我們在如此短的時間內取得的進展感到震驚。

  • This past quarter, our team grew testing volume 8% sequentially, which was our best total quarterly volume since we made adjustments to our ordering process last summer. It is exciting to see the momentum in test volume growth as we expected.

    上個季度,我們的團隊測試量較上季成長了 8%,這是自去年夏天我們調整訂購流程以來最好的季度總測試量。看到測試量增長的勢頭正如我們預期的那樣令人興奮。

  • Our sales team is making great progress in serving the rheumatology community, and they are energized by the successful quarter after working through significant change management with our customers over the past year. Additionally, we continue to increase our trailing 12-month average selling price for AVISE CTD, and for the first time, as a public company, are seeing ASPs exceed the $400 mark. This is an exciting milestone and one which we are very proud of.

    我們的銷售團隊在服務風濕病學界方面取得了巨大進步,在過去的一年中與客戶進行了重大變革管理後,他們對這個成功的季度充滿了活力。此外,我們繼續提高 AVISE CTD 過去 12 個月的平均售價,作為一家上市公司,平均售價首次突破 400 美元大關。這是一個令人興奮的里程碑,我們對此感到非常自豪。

  • We have made tremendous progress over the past six quarters, getting us closer to our near-term goal of attaining at least 50% of our CMS price for AVISE CTD. The combined efforts of increasing volume and growing ASP led to record quarterly revenue at just over $15 million in Q2. I'm encouraged by the growth and trajectory I'm seeing in our core AVISE business as we continue to execute well.

    在過去的六個季度中,我們取得了巨大進展,使我們更接近我們的近期目標,即實現 AVISE CTD 的 CMS 價格至少 50%。銷量增加和平均售價提高的共同努力導致第二季營收創歷史新高,略高於 1500 萬美元。隨著我們繼續良好地執行,我對核心 AVISE 業務的成長和軌跡感到鼓舞。

  • Additionally, and as we've conveyed throughout the year, we've identified areas where we can enhance our existing products and services. In Q4, we expect to upgrade our AVISE CTD offering through the addition of markers, which we believe will improve the sensitivity for SLE diagnosis and better capture patients with rheumatoid arthritis who would traditionally be diagnosed as seronegative RA.

    此外,正如我們全年所傳達的那樣,我們已經確定了可以增強現有產品和服務的領域。在第四季度,我們預計透過添加標記物來升級我們的 AVISE CTD 產品,我們相信這將提高 SLE 診斷的敏感性,並更好地捕獲傳統上被診斷為血清陰性 RA 的類風濕關節炎患者。

  • These are the top two options by prevalence under a connective tissue disease differential. And each of our product enhancements has a proprietary aspect, which we believe will provide significant competitive advantages. This past quarter, we made meaningful progress to advance development efforts, and I continue to expect that we will launch improvements to the AVISE CTD platform by year end.

    這是結締組織疾病差異下盛行率最高的兩個選項。我們的每項產品增強功能都有其專有的方面,我們相信這將提供顯著的競爭優勢。上個季度,我們在推動開發工作方面取得了有意義的進展,我仍然預計我們將在年底前推出 AVISE CTD 平台的改進。

  • Given our progress in improving the AVISE business, and the impact we expect from the launch of a revamped AVISE CTD profile. We expect to be cash flow positive within a year of launching both sets of new markers. Our horizon for achieving profitability is coming into focus, as we continue to execute on our strategy. As we near profitability, we've begun to see additional areas of opportunity for growth and expansion.

    鑑於我們在改善 AVISE 業務方面取得的進展,以及我們預期推出改進的 AVISE CTD 設定檔所產生的影響。我們預計在推出兩組新標記後一年內將出現正現金流。隨著我們繼續執行我們的策略,我們實現盈利的前景逐漸成為焦點。當我們接近獲利時,我們開始看到其他領域的成長和擴張機會。

  • In the second quarter, we signed the first substantial biopharma contracts since I've been here. This is an area of business where I believe we have untapped potential and have placed a heightened focus on better serving this segment of the immunology ecosystem. Our high quality testing, proprietary offerings and domain knowledge gives us an advantage in this space. And we will continue to build our capabilities as more pharma companies realize the superior service and quality they can receive by working with us.

    第二季度,我們簽署了自我來到這裡以來的第一份重大生物製藥合約。我相信這是一個尚未開發的業務領域,我們高度重視更好地為免疫學生態系統的這一部分提供服務。我們的高品質測試、專有產品和領域知識使我們在這一領域具有優勢。隨著越來越多的製藥公司認識到與我們合作可以獲得卓越的服務和質量,我們將繼續增強我們的能力。

  • Before I dive deeper into our financial performance for the second quarter, I want to extend the sincere appreciation for the contributions Kamal has made to the Exagen organization as he steps down. Over the past decade, he has held numerous roles at Exagen and been a strong steward of the financials. Kamal has been a key supporter throughout my transition and for that, I'm grateful.

    在深入探討第二季的財務表現之前,我想先對 Kamal 卸任後對 Exagen 組織的貢獻表示誠摯的謝意。在過去的十年中,他在 Exagen 擔任過多個職務,並且是財務方面的強有力的管家。卡邁勒在我的過渡過程中一直是我的重要支持者,我對此深表感激。

  • Subsequently, as we continue to execute our strategy and deliver meaningful profitable growth, I look forward to having Jeff Black join us on the executive team as our Chief Financial Officer. Jeff has been CFO of multiple public companies. His leadership and incredible track record of value creation will be advantageous as we progress to our next inflection point. Given our start to the year and our consistent resetting of internal expectations, now it's the perfect time to have Jeff join our mission of providing clarity and improving clinical outcomes for patients with autoimmune disease.

    隨後,隨著我們繼續執行我們的策略並實現有意義的利潤成長,我期待傑夫布萊克加入我們的執行團隊,擔任我們的財務長。傑夫曾擔任多家上市公司的財務長。當我們邁向下一個拐點時,他的領導力和令人難以置信的價值創造記錄將是有利的。鑑於我們今年的開局以及我們不斷重新設定的內部期望,現在是傑夫加入我們為自體免疫疾病患者提供清晰度和改善臨床結果的使命的最佳時機。

  • Now to dive in, our Q2 performance highlights the strength of our business under our revised strategy and shows what an intense focus on the customer can accomplish. To provide a few highlights, total revenues in the second quarter of 2024 were a record $15.1 million compared with $14.1 million in the second quarter of '23, a 6.6% increase. Total revenues were primarily driven by strong ASPs for AVISE CTD and increased volumes over the first quarter. Growth at Exagen is now being driven through a combination of increased clinical adoption and improved reimbursement.

    現在深入探討一下,我們第二季的業績突顯了我們修訂後的策略下的業務實力,並展示了對客戶的高度關注可以實現的目標。需要強調的是,2024 年第二季的總收入達到創紀錄的 1,510 萬美元,與 2023 年第二季的 1,410 萬美元相比,成長了 6.6%。總收入主要由 AVISE CTD 的強勁平均售價和第一季銷售成長推動。Exagen 目前的成長是透過增加臨床採用和改善報銷相結合來推動的。

  • Other testing revenue was $1.5 million in the second quarter of 2024 compared with $1.6 million in the same period last year. Our revenue cycle team continues to do a fantastic job as we again saw strong prior period collections with $1.3 million of revenue in the second quarter from tests performed over a year ago. Prior period collections are generally very difficult to forecast but continue to outpace our internal projections.

    2024 年第二季其他測試收入為 150 萬美元,而去年同期為 160 萬美元。我們的營收週期團隊持續表現出色,我們再次看到強勁的前期收款,根據一年多前進行的測試,第二季營收達到 130 萬美元。前期收款通常很難預測,但仍持續超出我們的內部預測。

  • Cost of revenue were $6 million this past quarter resulting in a total gross margin of just over 60% compared to 58.7% in Q2 of '23. The increase in gross margin was primarily driven by increases in ASP. Operating expenses excluding COGS for the second quarter of 2024 were $11.6 million compared with $13.2 million in Q2 of '23. Year-over-year decreases were primarily due to a reduction in legal fees and stock-based compensation as a result of lower headcount.

    上一季的營收成本為 600 萬美元,總毛利率略高於 60%,而 2023 年第二季為 58.7%。毛利率的成長主要是由平均售價的成長所推動的。2024 年第二季不包括銷貨成本的營運費用為 1,160 萬美元,而 2023 年第二季的營運費用為 1,320 萬美元。年比下降主要是因為員工人數減少導致法律費用和股票薪資減少。

  • The net loss in Q2 of '24 was $3 million compared with a $5 million loss in the same period last year, representing a 40% improvement. Adjusted EBITDA loss was $1.6 million for the second quarter of ‘24, compared to a $3.4 million loss for the second quarter of '23. Adjusted EBITDA loss through the first half of the year was $3.6 million compared to $9.6 million through the first two quarters of '23. As a reminder, our adjusted EBITDA excludes stock comp expense since it is a non-cash expense for the organization. Please refer to our earnings release issued earlier today for a reconciliation of adjusted EBITDA to net loss.

    2024 年第二季的淨虧損為 300 萬美元,與去年同期的 500 萬美元虧損相比,改善了 40%。2024 年第二季調整後 EBITDA 虧損為 160 萬美元,而 2023 年第二季調整後 EBITDA 虧損為 340 萬美元。今年上半年調整後的 EBITDA 損失為 360 萬美元,而 2023 年前兩季的調整後 EBITDA 損失為 960 萬美元。提醒一下,我們調整後的 EBITDA 不包括股票補償費用,因為它是組織的非現金費用。請參閱我們今天稍早發布的收益報告,以了解調整後 EBITDA 與淨虧損的調節表。

  • Looking at our balance sheet. Cash and cash equivalents as of June 30, 2024, were approximately $24.5 million and our accounts receivable balance was $11.7 million. Given our ability to drive profitable growth, we are increasing our full year guidance to at least $57 million in revenue and now believe our adjusted EBITDA loss will be better than $12 million, which is a dramatic improvement from our expectations just six months ago. Again, the launch of the new enhancements to AVISE CTD is expected to make us cash flow positive within the first year of launch.

    看看我們的資產負債表。截至 2024 年 6 月 30 日,現金及現金等價物約為 2,450 萬美元,應收帳款餘額為 1,170 萬美元。鑑於我們推動獲利成長的能力,我們將全年營收指引提高至至少 5,700 萬美元,現在相信調整後的 EBITDA 損失將好於 1,200 萬美元,這比我們六個月前的預期有了顯著改善。同樣,AVISE CTD 新增強功能的推出預計將使我們在推出的第一年內實現正現金流。

  • We will now open the call for questions.

    我們現在開始提問。

  • Operator

    Operator

  • Thank you. We will now be conducting a question-and-answer session. (Operator Instructions)

    謝謝。我們現在將進行問答環節。(操作員說明)

  • Kyle Mikson, Canaccord Genuity.

    凱爾米克森,Canaccord Genuity。

  • Kyle Mikson - Analyst

    Kyle Mikson - Analyst

  • Hey, guys. Thanks for the questions. Congrats on the results. I guess maybe, John, just on the ASP. So I think last quarter, maybe fourth quarter itself was just above $420 or so. Now it was maybe just about $400 maybe, $410. It's kind of stabilizing a bit at $400. I mean, how long could it take to get to $500 or so, like 50% of the list price or the Medicare price? And how critical is that? And could you take a step back and maybe try to reinvest to like drive volume growth rather than ASP? I mean how are you thinking about that? Are you kind of closing on this target here?

    嘿,夥計們。感謝您的提問。祝賀結果。約翰,我想也許只是在 ASP 上。所以我認為上個季度,也許第四季本身就略高於 420 美元左右。現在可能只有 400 美元左右,410 美元。價格穩定在 400 美元。我的意思是,需要多長時間才能達到 500 美元左右,例如標價或 Medicare 價格的 50%?這有多重要?您是否可以退後一步,嘗試進行再投資以推動銷售成長而不是平均售價?我的意思是你怎麼想這個?您已經接近這個目標了嗎?

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Good morning, Kyle. Thanks for the question. Very relevant. I think it's a good one. So the way we look at ASPs and our ambition there has not changed at all. Our goal has been, over the last couple of years has been to achieve that 50% level in the relatively near term. For AVISE CTD, that's somewhere around $525, just over that $500 mark. And so we pointed folks to the trailing 12-month number, really in anticipation of the quarter-to-quarter variability that we expected to see.

    早安,凱爾。謝謝你的提問。非常相關。我認為這是一件好事。因此,我們看待 ASP 的方式以及我們的抱負根本沒有改變。過去幾年我們的目標是在相對近期內達到 50% 的水平。對於 AVISE CTD 來說,價格約為 525 美元,略高於 500 美元大關。因此,我們向人們展示了過去 12 個月的數據,實際上是為了預期我們預期會看到的季度變化。

  • We think we've had a great quarter and we continue to push the AVISE ASP up. And so from our perspective, the view really hasn't changed. So while you see that quarter-to-quarter transition, there's nothing meaningful really behind that in terms of negative trends or anything like that. So our goal store remains the same. We've never really guided to an exact time point as to when we believe we'll hit it. It's just inherently difficult to forecast.

    我們認為我們度過了一個出色的季度,並且我們將繼續推高 AVISE 的平均售價。因此,從我們的角度來看,這種觀點確實沒有改變。因此,雖然您看到季度與季度之間的轉變,但就負面趨勢或類似情況而言,背後並沒有什麼真正有意義的東西。所以我們的目標商店保持不變。我們從來沒有真正指導過一個確切的時間點,以確定我們何時會實現這一目標。這本身就很難預測。

  • Some of these things that really drive momentum can be changes in payer behavior, but also things that we can do, but our appeals efforts remain strong. We're starting to get some of that feedback in, now that we've completed three or four levels of appeals. And so we still remain just as optimistic as we were maybe even more so given the progress we've made over the last several months.

    其中一些真正推動勢頭的事情可能是付款人行為的變化,但也是我們可以做的事情,但我們的呼籲努力仍然強勁。現在我們已經完成了三到四個級別的上訴,我們開始收到一些回饋。因此,我們仍然保持樂觀態度,考慮到我們在過去幾個月的進展,我們可能會更加樂觀。

  • Kyle Mikson - Analyst

    Kyle Mikson - Analyst

  • I got it. Sounds good. Thanks for that. And then, we kind of implied or like inherent in that question was just kind of the investment in commercial key, commercial expansion, driving volume growth rather than ASP, and collections and things like that. So SG&A has been pretty stable the past couple of quarters last year, the quarterly level is much higher. I mean maybe just refresh us on the plans to increase the sales force and kind of expand your reach penetration in the rheumatologist market in the country.

    我得到了它。聽起來不錯。謝謝你。然後,我們暗示或喜歡這個問題的本質只是對商業密鑰、商業擴張、推動銷售成長的投資,而不是平均售價、收藏品和類似的東西。因此,去年過去幾季的銷售管理費用(SG&A)相當穩定,季度水準也高得多。我的意思是,也許只是讓我們了解一下增加銷售隊伍的計劃,並擴大您在該國風濕病專家市場的滲透率。

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Yeah, absolutely. So the exciting thing for us is, we had anticipated reshaping the organization. And from a strategic standpoint, at the heart of what we're doing is, is driving ASP improvement. If you recall, that has not really been done at all for the four years prior to me joining the organization. And now we've seen a 40% increase from 2022 levels. So we're being successful in that regard.

    是的,絕對是。因此,對我們來說令人興奮的事情是,我們預計會重塑組織。從策略角度來看,我們所做工作的核心是推動 ASP 改進。如果您還記得的話,在我加入該組織之前的四年裡,實際上根本沒有這樣做過。現在我們看到比 2022 年的水準增加了 40%。所以我們在這方面取得了成功。

  • At the same time, it's required us to reset some of the ordering process with our clinicians, and that had, what we call the kind of a transient effect on our volume, and that sort of kicked-off in this time last year. And from our perspective, Q2 now, we've seen that volume growth and that was what we expected. That's been the plan all along.

    同時,它要求我們與臨床醫生一起重新設定一些訂購流程,這對我們的數量產生了我們所說的短暫影響,​​這種影響是在去年的這個時候開始的。從我們的角度來看,現在第二季度,我們已經看到了銷售量的成長,這正是我們的預期。這一直是計劃。

  • Timing is kind of right about what we expected as well. So I couldn't have drawn it up any better as we see it. And where we sit now, this is really growth due to two different levers. One continues to be on the volume side. One continues to be on the ASP side. You asked me specifically, about growing the sales team, we continue to have a 40 territory footprint across the United States.

    時機也符合我們的預期。因此,正如我們所見,我無法將其繪製得更好。從我們現在的情況來看,這確實是由兩種不同槓桿推動的成長。其中一個仍然是在音量方面。其中一個仍然是 ASP 方面。您具體問過我關於發展銷售團隊的問題,我們的業務涵蓋美國 40 個地區。

  • We believe for now that is the right footprint. We've rightsized the organization when I first started. And then, with the volume impact last year, it's still the right-sized organization for us right now. We continue to monitor each territory for profitability. And we'll split those territories or expand into areas that we're covering with an inside sales force over time, but nothing new to report there.

    我們目前認為這是正確的足跡。當我剛開始工作時,我們就對組織進行了調整。然後,考慮到去年銷售的影響,現在它仍然是我們規模合適的組織。我們繼續監控每個地區的獲利能力。隨著時間的推移,我們將分割這些領域或擴展到我們由內部銷售人員涵蓋的領域,但沒有什麼新的可報告的。

  • I do think in terms of the operating expense in general, $10,500 for SG&A is likely a little low. We're going into a product launch here in the second half of the year, product enhancement in two fronts. So our marketing expenses are likely to increase. As we do that, we may also incentivize the sales team in different ways throughout that period, and we'll have to see how commissions break out.

    我確實認為就整體營運費用而言,SG&A 10,500 美元可能有點低。我們將在下半年推出產品,從兩個方面進行產品增強。所以我們的行銷費用可能會增加。當我們這樣做時,我們也可能會在整個期間以不同的方式激勵銷售團隊,我們必須看看佣金是如何爆發的。

  • But overall, operating expense kind of coming in under $18,000 is probably not the best way to model it, right, in that $18,000 level is probably reasonable, especially when you factor in our R&D expenses are likely to increase as we move through validation of these different enhancements. So hopefully that gives you some color.

    但總體而言,營運費用低於18,000 美元可能不是建模的最佳方式,對吧,因為18,000 美元的水平可能是合理的,特別是當你考慮到我們的研發費用可能會隨著我們驗證這些費用而增加時不同的增強功能。希望這能給你一些色彩。

  • Kyle Mikson - Analyst

    Kyle Mikson - Analyst

  • Yeah. That was interesting. Thanks for that. And then, I guess just moving to the third quarter. It's kind of, in the end of the year is interesting for Exagen given some of the industry dynamics and stuff conference ACR, I think, November. So how should we be thinking about the third quarter, fourth quarter kind of cadence as you accelerate into 2025, I guess? And then maybe talk a little bit about how you feel about core growth, like, excluding the prior period collections heading into year-end kind of thing, just given the momentum into business recently?

    是的。這很有趣。謝謝你。然後,我想只是進入第三季。考慮到一些行業動態和 ACR 會議,我認為,今年年底對 Exagen 來說很有趣,我認為是 11 月。那麼,我想,隨著您加速進入 2025 年,我們應該如何考慮第三季、第四季的節奏?然後也許可以談談您對核心成長的看法,例如,考慮到最近的業務勢頭,排除進入年底的前期系列?

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Sure. So are you asking more on the revenue side, adjusted EBITDA or the entire picture?

    當然。那麼您是在收入方面、調整後的 EBITDA 還是整體情況上詢問更多?

  • Kyle Mikson - Analyst

    Kyle Mikson - Analyst

  • The topline revenue?

    總收入?

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • So in the second half of the year, we typically or historically have seen some seasonality impact. We're certainly seeing this with some of our top clinicians, extended vacations. You see it in the news. Airports are extremely busy when our team is flying, when I'm flying. So we do see some of that impact right now. We expect to continue into Q3. As you referenced, Q4 has the most holidays out of any quarter in the year.

    因此,在今年下半年,我們通常或歷史上會看到一些季節性影響。我們確實在一些頂級臨床醫生身上看到了這種情況,並延長了假期。你在新聞上看到了。當我們的團隊飛行時,當我飛行時,機場非常繁忙。所以我們現在確實看到了一些影響。我們預計這種情況會持續到第三季。正如您所提到的,第四季是一年中假期最多的季度。

  • And for us, we have a rheumatology societal meeting in the month of November, the week before Thanksgiving. So that pulls a good chunk of the rheumatology community out of clinical practice for at least a week, and then it piggybacks onto a holiday week. So we do see either a flattening or even slight decline historically. We're working hard to change that trend, and I think the team is highly motivated to do so, especially in light of a few product enhancements, which were coming over Q4.

    對我們來說,我們將在 11 月(感恩節前一周)召開風濕病學會會議。因此,風濕病學界的很大一部分人至少在一周內脫離臨床實踐,然後又利用假期週。因此,我們確實看到歷史上要么持平,要么略有下降。我們正在努力改變這種趨勢,我認為團隊非常有動力這樣做,特別是考慮到第四季度即將推出的一些產品增強功能。

  • So from our perspective, we'll have to see exactly how it shapes out. But if you look at the first half of the year and remove out of period revenue, that $2 million in prior period collections, basically, the guide that we've provided takes into account the sentiment I just conveyed. And that is that relatively flat due to seasonality impact as we continue to grow into 2025.

    因此,從我們的角度來看,我們必須確切地看到它是如何形成的。但是,如果你看看今年上半年並剔除期外收入,即前期收款中的 200 萬美元,基本上,我們提供的指南考慮了我剛才表達的觀點。隨著我們繼續增長到 2025 年,由於季節性影響,這一數字相對持平。

  • Kyle Mikson - Analyst

    Kyle Mikson - Analyst

  • Okay. That was great. I'll leave it there. Thanks, John. And definitely, it was great working with Kamal and good to see Jeff on board now. Thanks.

    好的。那很棒。我會把它留在那裡。謝謝,約翰。當然,與 Kamal 合作非常棒,很高興現在看到 Jeff 加入。謝謝。

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Great. Thanks so much, Kyle.

    偉大的。非常感謝,凱爾。

  • Operator

    Operator

  • Mark Massaro, BTIG.

    馬克·馬薩羅,BTIG。

  • Mark Massaro - Analyst

    Mark Massaro - Analyst

  • Hey, good morning. Thanks for taking the questions, John. Maybe the first one, this I think is obvious, but it looks like you beat in Q2 by $2 million. You raised the full year guide by $2 million. Just confirming that you're not changing how you expect trends in the back half of the year. Obviously, I heard your comments about seasonality. But you had a strong 8% quarter-over-quarter, excuse me, 8% quarter-over-quarter increase in volumes.

    嘿,早安。感謝您提出問題,約翰。也許是第一個,我認為這是顯而易見的,但看起來你在第二季度領先了 200 萬美元。您將全年指南提高了 200 萬美元。只要確認您不會改變下半年趨勢的期望。顯然,我聽到了你對季節性的評論。但抱歉,季度環比增長了 8%,銷量環比增長了 8%。

  • I assume you're not expecting or embedding in your guidance any change to the volume trajectory in the back half of the year relative to the prior year. I guess I'm just trying to confirm that the raise for the full year was a function of the outperformance in Q2 and not changes to your underlying trends in the back half?

    我認為您不會預期或在您的指導中嵌入今年下半年相對於上一年的成交量軌蹟的任何變化。我想我只是想確認全年的加薪是第二季表現出色的結果,而不是後半段基本趨勢的變化?

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Sure. Good morning, Mark. Thanks for the question. As you said, no, there's no changes in expectation for growth of the business. We've said that projections of ASP increases over time are inherently difficult just given the magnitude and the dependencies on certain payer behavior.

    當然。早上好,馬克。謝謝你的提問。正如您所說,不,對業務成長的預期沒有變化。我們已經說過,考慮到幅度以及對某些付款人行為的依賴性,預測平均售價隨時間的增長本質上是困難的。

  • So that's always a challenging thing to forecast, that's one lever of our growth. From a volume standpoint, the 8% sequential growth quarter-over-quarter, that's fantastic. Just historically, Q3, Q4 has been kind of a leveling. Q1, Q2 has been really where we build from a volume standpoint, but we'll see.

    因此,預測這始終是一件具有挑戰性的事情,這是我們成長的一個槓桿。從銷量的角度來看,環比增長 8%,這真是太棒了。從歷史上看,第三季、第四季一直是一種拉平。從銷售的角度來看,第一季和第二季確實是我們建造的地方,但我們拭目以待。

  • Again, like I said, the sales team, this is not the message to them. This is just if you look at this from an analyst standpoint or evaluate the business, these have been historical trends that seem to sit within the rheumatology community and the way clinical practice is handled here. So no change in terms of our outlook, so very optimistic. Like, the trajectory, like, both levers are leading to growth here, and we'll see kind of how we perform in the back half of the year.

    再說一遍,就像我說的,銷售團隊,這不是給他們的訊息。如果你從分析師的角度來看這個問題或評估業務,這些都是風濕病學界和臨床實踐處理方式的歷史趨勢。所以我們的前景沒有改變,所以非常樂觀。就像軌跡一樣,兩個槓桿都導致這裡的成長,我們將看到我們在今年下半年的表現。

  • Mark Massaro - Analyst

    Mark Massaro - Analyst

  • Okay. Great. You mentioned the biopharma ad. Nice to see. I know that used to be a pretty significant piece to the Exagen business strategy over the years, going back to the IPO. Can you maybe just remind us how many of your 40 or so reps, I mean who's driving the pharma demand? I can't imagine it's all 40 of your reps. So is there a specialized team? I could probably use a refresher on that? And then, how should we think about biopharma over the next couple of years? I mean I don't expect huge wins in the near term per se. But just curious how you view this test and treat strategy and what types of deals you're looking to sign?

    好的。偉大的。您提到了生物製藥廣告。很高興看到。我知道,多年來,這曾經是 Exagen 業務策略中非常重要的一部分,可以追溯到 IPO。您能否提醒我們,您的 40 名左右的代表中有多少人,我的意思是誰在推動藥品需求?我無法想像這就是你的 40 次重複。那麼有專門的團隊嗎?我也許可以複習一下?那麼,未來幾年我們該如何看待生物製藥呢?我的意思是,我預計短期內不會取得巨大的勝利。但只是好奇您如何看待這項測試和治療策略以及您希望簽署哪種類型的交易?

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Absolutely. This was a great development for us in Q2. And just to be clear, our business model is to serve the community based rheumatologists in their clinical practice, that's where AVISE CTD holds the greatest clinical value is in the day-to-day management of patients with suspected underlying connective tissue disease. So our biopharma revenue and especially, the contracts that we've signed more recently are not in that vein. And we don't dilute the message from our sales organization in this regard.

    絕對地。這對我們在第二季來說是一個巨大的發展。需要明確的是,我們的商業模式是在臨床實踐中為社區風濕病學家提供服務,這就是 AVISE CTD 最大的臨床價值在於對疑似潛在結締組織疾病患者的日常管理。因此,我們的生物製藥收入,尤其是我們最近簽署的合約並非如此。我們不會淡化我們銷售組織在這方面傳達的訊息。

  • So we have under our Chief Medical Officer, Dr. Mike Nerenberg. We have established a small team, a small biopharma team, and they've been actively working for the last nine months or so, in seeing what businesses out there. And it seems to be some initial good feedback is really the message I wanted to convey. It was great to see the new contract come in. We do offer a differentiated service in this area. We're known for our high quality testing.

    我們的首席醫療官是 Mike Nerenberg 博士。我們已經建立了一個小團隊,一個小型生物製藥團隊,他們在過去九個月左右的時間裡一直在積極工作,看看那裡有什麼業務。似乎一些最初的良好回饋確實是我想傳達的訊息。很高興看到新合約的簽訂。我們確實在這一領域提供差異化服務。我們以高品質測試而聞名。

  • We have proprietary markers for clinical trials, enrollment that is or further characterization in these patients. And so that combined with the quality of testing that we perform, we're starting to enhance our build the brand within the pharma community. And so, we'll see how this business evolves. I'm sure you're aware in some of the other companies that you follow biopharma revenues incredibly lumpy and also difficult to forecast.

    我們擁有用於臨床試驗、入組或進一步表徵這些患者的專有標記。因此,結合我們執行的測試質量,我們開始加強我們在製藥界的品牌建設。因此,我們將看看這項業務如何發展。我相信您知道其他一些公司的生物製藥收入極不穩定且難以預測。

  • So layering some of that stuff on, but we'll take it because it tends to be a higher margin business and then also, from our standpoint, we've adjusted the way that we set up these contracts so that there is some level of minimum performance. So we do expect this to be a meaningful impact to the organization. Hence, my reason for mentioning it. But unsure exactly how big or large of a business this can become just seems to be a good first start. But it is a separate team.

    因此,將其中一些內容分層,但我們會接受它,因為它往往是利潤率較高的業務,然後從我們的角度來看,我們調整了建立這些合約的方式,以便有一定程度的最低性能。因此,我們確實希望這會對​​組織產生有意義的影響。因此,我有理由提及它。但不確定這家企業到底能發展到多大,這似乎是一個好的開始。但這是一個獨立的團隊。

  • Mark Massaro - Analyst

    Mark Massaro - Analyst

  • Okay. Got it. I will also reiterate my pleasure working with Kamal over the years, and welcome, Jeff, to the organization. But I want to put my third question here on the T-cell markers. So I know you've talked about being able to identify more patients with SLE who otherwise would have tested negative. So inherently, I think that provides a significant opportunity for you.

    好的。知道了。我還要重申多年來與卡邁勒合作的愉快,並歡迎傑夫加入該組織。但我想提出第三個問題,關於 T 細胞標記。我知道您曾談到能夠識別出更多系統性紅斑狼瘡的患者,否則這些患者的檢測結果會呈現陰性。因此,從本質上講,我認為這為您提供了一個重要的機會。

  • But I'm just curious if you've had additional time perhaps to think about what that opportunity could mean in dollars because I think people are trying to figure out the incremental -- I know some companies who launch next-gen, there's not always a revenue inflection. Perhaps it's greater ease of use or there are other characteristics of the next-gen launch. But over the next several years, how should we think about the incremental change in demand for Exagen and then as it relates to pricing, do you see any potential path to get a higher price from payers as a result of the next gen?

    但我只是好奇你是否有更多的時間來思考這個機會對美元意味著什麼,因為我認為人們正在試圖找出增量 - 我知道一些推出下一代的公司,並不總是有收入的變化。也許是更容易使用,或者下一代產品還有其他特點。但在接下來的幾年裡,我們應該如何考慮 Exagen 需求的增量變化,然後當它與定價相關時,您是否認為下一代產品有任何潛在途徑可以從付款人那裡獲得更高的價格?

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • That's a great question. So to explain to everyone, one of the things that makes AVISE CTD unique and so valuable to clinicians is that we've taken the time to research and then subsequently demonstrate through our own trials what the most relevant markers are for aiding a diagnosis when a broad differential is being evaluated.

    這是一個很好的問題。因此,向大家解釋一下,使AVISE CTD 獨一無二且對臨床醫生如此有價值的原因之一是,我們花時間進行研究,然後透過我們自己的試驗證明,當出現以下情況時,最相關的標記物可以幫助診斷:正在評估廣泛的差異。

  • So these product enhancements, they, as you mentioned, Mark, improved the sensitivity of two sub profiles within AVISE CTD. So specifically within the systemic lupus erythematosus and the rheumatoid arthritis sub profiles. So these enhancements will be available individually but also as part of a revised CTD offering.

    因此,正如您所提到的,Mark,這些產品增強功能提高了 AVISE CTD 內兩個子配置檔案的靈敏度。特別是在系統性紅斑狼瘡和類風濕性關節炎的亞型。因此,這些增強功能將單獨提供,但也可以作為修訂後的 CTD 產品的一部分提供。

  • We do expect an immediate clinical benefit to physicians, but also to reflect that benefit in ASP virtually from launch. So I'd like to see exactly how that reimbursement lands once we start getting claims adjudicated, but I said it will be margin accretive and meaningful. We've also now come out and said, with this earnings call that within a year of launching both product enhancements that we expect to be a cash flow positive organization. And historically, we've said that we reached that level with 60% margins and around $75 million in revenue.

    我們確實期望醫生能立即獲得臨床益處,而且從發布之日起,這種益處就會體現在 ASP 中。因此,我想了解一旦我們開始對索賠進行裁決,報銷將如何落實,但我說這將增加利潤並且有意義。我們現在也透過這次財報電話會議表示,在推出這兩項產品增強功能後的一年內,我們預計將成為一家現金流為正的組織。從歷史上看,我們曾說過,我們以 60% 的利潤率和約 7500 萬美元的收入達到了這一水平。

  • So from a run rate standpoint, our organization is starting to move in that direction. And at least our initial projections are that we're there towards the end of that first year of launch of both product enhancements. So that's how we're thinking about it internally. You never really have certainty until you start to get some of those claims adjudicated and see how it goes. But these are additional markers that we're adding into CTD so that you understand kind of operationally, how this is being handled. Volume impact, it takes time to educate folks on the utility of these new markers, what value they bring clinically, how to use them.

    因此,從運作率的角度來看,我們的組織正開始朝這個方向發展。至少我們最初的預測是,我們將在第一年年底推出這兩項產品增強功能。這就是我們內在的思考方式。在你開始對其中一些索賠進行裁決並看看進展如何之前,你永遠不會真正有確定性。但這些是我們添加到 CTD 中的附加標記,以便您在操作上了解如何處理此問題。影響數量,需要時間來教育人們這些新標記的實用性、它們在臨床上帶來的價值以及如何使用它們。

  • And especially, we're doing it across two disease states. So that will take some time. As we're looking at it, about a year is, what our current expectation is to get a full realization of the ASP impact, gain confidence there, but also to get that message out and have it resonate with clinicians such that we're driving volume. And that combination likely gets us above that 60% level, kind of in the low-60s is how we’re looking at it from a margin standpoint and then having our top line kind of hit that mark of cash flow positivity.

    尤其是,我們正在針對兩種疾病狀態進行這項工作。所以這需要一些時間。正如我們所看到的,大約一年的時間,我們目前的期望是充分認識 ASP 的影響,獲得信心,同時傳達該訊息並引起臨床醫生的共鳴,以便我們能夠駕駛音量。這種組合可能會讓我們高於 60% 的水平,也就是我們從利潤率角度看待它的方式,然後讓我們的營收達到現金流量正值的水平。

  • Mark Massaro - Analyst

    Mark Massaro - Analyst

  • Okay. Great. Congrats on this current quarter.

    好的。偉大的。恭喜本季。

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Thanks, Mark.

    謝謝,馬克。

  • Operator

    Operator

  • Dan Brennan, TD Cowen.

    丹布倫南,TD·考恩。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Great. Thanks. Thanks for the questions. Maybe the first one just on the better-than-expected kind of EBITDA levels that you're seeing $3.6 million loss in the first half. I think the guide now you raised by $6 million, right, from $18 million down to $12 million, so really nice raise. Arguably still looks conservative given the first half run rate. Could you just speak a little bit more to how we think about cost trends in the back half of the year? I know you discussed the new products and what that's going to entail. But I'm just kind of trying to put how like a $3.6 million first-half loss translates into a $12 million full-year loss.

    偉大的。謝謝。感謝您的提問。也許第一個只是關於好於預期的 EBITDA 水平,您會看到上半年虧損 360 萬美元。我認為指南現在籌集了 600 萬美元,對吧,從 1800 萬美元減少到 1200 萬美元,所以籌集得非常好。考慮到上半場的運行率,可以說看起來仍然保守。能否再多談談我們對下半年成本趨勢的看法?我知道您討論了新產品以及新產品的含義。但我只是想說明一下,上半年 360 萬美元的虧損如何轉化為全年 1,200 萬美元的虧損。

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Great. Good morning, Dan. Thanks for the question. Certainly, a good one, highly relevant. The way we look at it, we're being very prudent with managing expenses of the organization. But from an OpEx standpoint that less than $12 million per quarter is not a run rate to model. So we do expect some of our cost to increase, especially, when you're launching two new product enhancements. As you would expect, we're going to have a marketing campaign associated with these product enhancement launches.

    偉大的。早上好,丹。謝謝你的提問。當然,這是一篇好文章,高度相關。從我們的角度來看,我們在管理組織費用方面非常謹慎。但從營運支出的角度來看,每季低於 1,200 萬美元並不是模型的運作率。因此,我們確實預期我們的一些成本會增加,特別是當您推出兩種新產品增強功能時。正如您所期望的,我們將開展與這些產品增強功能發布相關的行銷活動。

  • There will be some commission impact from a sales standpoint. There's also some increased R&D expense. The methodology for one of these product enhancements is flow cytometry. We have to have prospective samples in order to validate this assay. And so, we're running a clinical trial from that, and we have to time everything perfectly so that we validate when the assay is ready, and we're ready to do that analytical validation.

    從銷售的角度來看,佣金會受到一些影響。研發費用也有所增加。這些產品增強功能之一的方法是流式細胞儀。我們必須有前瞻性樣本才能驗證該檢測。因此,我們正在進行一項臨床試驗,我們必須完美地安排一切時間,以便我們在檢測準備就緒時進行驗證,並且我們準備好進行分析驗證。

  • So those expenses are likely to increase in the back half of the year. So that's what we factored in, in terms of our guide on the adjusted EBITDA side. Also, as we've said, it's very difficult to forecast prior period or out-of-period collections. And so, we had $2 million in terms of the impact here in the first half. We're working hard to see what we can collect in the back half of the year. But we do expect this over time to continue to reduce as it gets factored into the accrual rate.

    因此,這些費用可能會在今年下半年增加。這就是我們在調整後 EBITDA 方面的指南中考慮的因素。此外,正如我們所說,預測前期或期外收款非常困難。因此,就上半年的影響而言,我們有 200 萬美元。我們正在努力看看下半年能收集到什麼。但我們確實預計,隨著時間的推移,這一數字將繼續減少,因為它將被計入應計利率中。

  • So I think those two factors are important to keep in mind. The other thing maybe I'll just point you to is, in our 10-K, maybe you would have picked up on that we had 170 FTEs here at Exagen at the end of last year, that number is likely a little too low. as we've gone through the year. It's not going to be dramatically above that. But there were a few key positions that we had to fill within the organization here have done so more recently. And so those are all factors that we're taking into account.

    所以我認為記住這兩個因素很重要。我可能要向您指出的另一件事是,在我們的 10-K 中,也許您會發現去年年底我們在 Exagen 擁有 170 名 FTE,這個數字可能有點太低了。正如我們已經走過的這一年。它不會顯著高於這個數字。但我們必須在組織內填補一些關鍵職位,最近我們已經這麼做了。這些都是我們正在考慮的因素。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Got it. Thank you for that. And then maybe just on the new markets, I know on the last call, you discussed some of the performance enhancements in terms of the area under the curve and better sensitivity and kind of those factors.

    知道了。謝謝你。然後也許只是在新市場上,我知道在上次通話中,您討論了曲線下面積和更好的敏感性以及這些因素的一些性能增強。

  • Could you just maybe speak to a little bit of like what you're hearing from the field as you get ready to launch these products like from a kind of volume basis, what kind of maybe penetration increases could entail just given the better performance, could you kind of shake some of the doctors that haven't been using the test kind of into your user base because of that? Just any color there would be helpful.

    當您準備推出這些產品時,您能否談談您從現場聽到的一些內容,例如從某種數量的基礎上考慮,考慮到更好的性能,可能會帶來什麼樣的滲透率增長?您是否因此而將一些尚未使用該測試的醫生納入您的用戶群?任何顏色都會有幫助。

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Certainly. So timing-wise, we're going to certainly have a large educational campaign here in Q4 as we get close to launching these. And it just happens kind of perfect timing, if you will, that the rheumatology societal meeting is also in Q4. So we'll get a lot of feedback here in the month of November as we work with folks, but we've done a lot of market research up to this point. And pretty universally, the feedback is very positive. Clinically, this is a challenging dilemma for folks. You've got suspected connective tissue disease differential with the patient.

    當然。因此,就時間安排而言,當我們即將推出這些活動時,我們肯定會在第四季度舉辦大型教育活動。如果你願意的話,風濕病學會會議也在第四季度舉行,這恰好是一個完美的時機。因此,當我們與人們合作時,我們將在 11 月收到很多回饋,但到目前為止我們已經做了很多市場研究。一般來說,回饋都是非常正面的。在臨床上,這對人們來說是一個具有挑戰性的困境。您懷疑該患者患有結締組織疾病。

  • And the more accurate test that you can provide the better, that's why they use AVISE CTD now, and we're making it only that much more improved. So from our standpoint, the feedback has been very positive. It certainly continues to address a high clinical need within the rheumatology community. We'll see exactly how it shapes out volume wise in 2025. But positive so far has been key -- feedback so far has been very positive, excuse me.

    您提供的測試越準確越好,這就是他們現在使用 AVISE CTD 的原因,我們正在對其進行進一步改進。因此,從我們的角度來看,反饋非常積極。它肯定會繼續滿足風濕病學界的高臨床需求。我們將在 2025 年確切地看到它的銷量如何。但到目前為止,正面的回饋一直是關鍵——抱歉,到目前為止的回饋非常正面。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Got it. And then maybe last one in terms of the claims that you've been holding. Just kind of remind us, like, are you fully kind of processing a lot of the claims given where pricing is today? Just how do we think about that as we look out to the back half of the year end of '25.

    知道了。然後也許是最後一個關於你一直持有的主張的問題。只是提醒我們,例如,你們是否完全處理了今天定價中給出的大量索賠?當我們展望 25 年下半年時,我們如何看待這個問題?

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Yeah. So at the beginning of each year, we hold claims as a strategy that we have that we believe improves our revenue cycle opportunities and so we do that. And then, in late Q2 into Q3, we released those claims out to the various insurance organizations and then go from there. And so, we've done that here in Q2. You see ARR increased by about $1 million. Our cash position is very strong. So is played out or is playing out very similar to how it did last year. And we’ll see kind of how the back half of the year goes in terms of this, but claims are being released and it’s just business as usual in that regard.

    是的。因此,每年年初,我們都會將索賠作為一項策略,我們相信它可以改善我們的收入週期機會,因此我們會這樣做。然後,在第二季末到第三季度,我們將這些索賠發布給各個保險公司,然後從那裡開始。因此,我們在第二季就做到了這一點。您會看到 ARR 增加了大約 100 萬美元。我們的現金狀況非常強勁。所以現在的情況或正在發生的情況與去年非常相似。我們將看到下半年這方面的情況如何,但索賠正在發布,在這方面一切如常。

  • Daniel Brennan - Analyst

    Daniel Brennan - Analyst

  • Great. Okay. Thank you very much, John.

    偉大的。好的。非常感謝你,約翰。

  • Operator

    Operator

  • Ross Osborn, Cantor Fitzgerald.

    羅斯·奧斯本,康托·菲茨杰拉德。

  • Ross Osborn - Analyst

    Ross Osborn - Analyst

  • Hey, good morning, everyone. Congrats on the results. Maybe starting-off with just a bigger question from us. Given your success in turning Exagen around the drug in an efficient manner, how are you thinking about the longer-term story at this point? Just in terms of your product portfolio, with the business reaching cash flow breakeven in a year or so, are you thinking more about bringing in a new test at this point or is there a runway for the AVISE CTD test in that it will be the focus for the next several years? Thank you.

    嘿,大家早安。祝賀結果。也許我們會從一個更大的問題開始。鑑於您成功地以有效的方式扭轉了 Exagen 的局面,您目前如何考慮長期發展?就您的產品組合而言,隨著業務在一年左右的時間內達到現金流收支平衡,您是否更多地考慮在此時引入新的測試,或者是否存在AVISE CTD 測試的跑道,因為它將是未來幾年的重點?謝謝。

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Hey, Ross. Good morning. I appreciate the question. It's a fun question to ponder. To be honest, especially, given where I joined the organization a couple of years ago, it was something I thought about, but wasn't quite at the forefront of what I had to work on. And so, it is coming more into view. I appreciate that perspective.

    嘿,羅斯。早安.我很欣賞這個問題。這是一個值得思考的有趣問題。老實說,特別是考慮到我幾年前加入該組織的情況,這是我考慮過的事情,但不是我必須做的工作的最前沿。因此,它越來越受到人們的關注。我很欣賞這種觀點。

  • From our standpoint, the organization is transforming and we've shown material progress. that was -- it's exciting to see and it's exciting to be operating a business that is very close in this regard, right? And I think that, that's certainly what I've wanted to do, and I'm really looking forward to it over the next couple of years. I think we'll be able to do some fun things as we move into more capital allocation type strategies.

    從我們的角度來看,組織正在轉型,我們已經取得了實質進展。那是——看到這一點令人興奮,並且經營一家在這方面非常接近的企業也令人興奮,對吧?我認為,這當然是我想做的事情,而且我真的很期待未來幾年的發展。我認為,當我們轉向更多的資本配置類型策略時,我們將能夠做一些有趣的事情。

  • And so from our perspective, AVISE CTD still has quite a bit of room to go. If we take a look at how we're thinking about this, 40 million to 45 million Americans are ANA positive and then subsequently referred into rheumatology for clinical evaluation of suspected autoimmune condition. We think that we're somewhere kind of mid-single digits in terms of market penetration with AVISE CTD.

    因此,從我們的角度來看,AVISE CTD 仍有很大的發展空間。如果我們看看我們是如何思考這個問題的,就會發現有 4000 萬到 4500 萬美國人呈 ANA 陽性,然後轉診至風濕病科,對疑似自體免疫疾病進行臨床評估。我們認為,就 AVISE CTD 的市場滲透率而言,我們處於中個位數的水平。

  • So we've got a lot of room on that front. I think these new product enhancements, we'll see how they work in terms of clinical adoption and what the impact is there. We also think that from an ASP perspective, we still have some room to go.

    所以我們在這方面有很大的空間。我認為這些新產品的增強,我們將看到它們在臨床採用方面如何發揮作用以及產生什麼影響。我們也認為,從 ASP 的角度來看,我們還有一些發展空間。

  • And as I mentioned, kind of that 500 mark is a good clip, so that's a decent growth from our perspective, just on the base business. Additionally, one of the things we've done over the last two years has completely revamped our R&D efforts. And we do have exciting opportunities there. The rheumatology community, this is not the only area where they need proprietary information and diagnostics.

    正如我所提到的,500 的大關是一個很好的剪輯,因此從我們的角度來看,僅就基礎業務而言,這是一個不錯的成長。此外,我們過去兩年所做的一件事徹底改變了我們的研發工作。我們在那裡確實有令人興奮的機會。對於風濕病學界來說,這並不是他們需要專有資訊和診斷的唯一領域。

  • And so, disease activity scores, both in SLE, along with rheumatoid arthritis or something that we're actively looking at. We've also looked at diagnostic and therapeutic response Within a subset of SLE patients, those with lupus nephritis.

    因此,疾病活動評分,包括系統性紅斑狼瘡、類風濕性關節炎或我們正在積極研究的疾病。我們也研究了一部分 SLE 患者(即狼瘡性腎炎患者)的診斷和治療反應。

  • And there's a few other efforts that seem to look promising from the research that we've done. So we'll continue to build out our own pipeline of opportunities and first and foremost, it starts with customer need. And I think we've got a good handle on that.

    從我們所做的研究來看,還有一些其他的努力看起來很有希望。因此,我們將繼續建立自己的機會管道,首先也是最重要的是,從客戶需求開始。我認為我們已經很好地處理了這個問題。

  • But then we'll also, as we become a cash flow positive and subsequently a profitable organization, look for what else is out there and see how we can enhance our business profile in that regard from an inorganic opportunity standpoint. So fun to be thinking about it, that was one of the reasons why I'm super excited for Jeff to join and be able to leverage some of his experience there. So we'll see where it goes.

    但是,當我們成為一個正現金流並隨後成為一個盈利組織時,我們也會尋找其他東西,看看我們如何從無機機會的角度增強我們在這方面的業務形象。思考這個問題很有趣,這就是為什麼我對傑夫的加入感到非常興奮並能夠利用他在那裡的一些經驗的原因之一。所以我們會看看它會走向何方。

  • Ross Osborn - Analyst

    Ross Osborn - Analyst

  • All right. Sounds great. Congratulations on the progress. Thank you.

    好的。聽起來很棒。祝賀取得的進展。謝謝。

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Thanks, Ross.

    謝謝,羅斯。

  • Operator

    Operator

  • Andrew Brackmann, William Blair.

    安德魯·布拉克曼,威廉·布萊爾。

  • Andrew Brackmann - Analyst

    Andrew Brackmann - Analyst

  • Hey, guys. Good morning. Thanks for taking the question. Maybe on the AVISE enhancements, can you maybe just be a bit more specific on training and education plans around these ads? Anything that we should sort of be on the lookout for, whether it's industry conferences, KOL, events, peer-to-peer, anything like that in the back half of the year? Thanks.

    嘿,夥計們。早安.感謝您提出問題。也許關於 AVISE 的增強功能,您能否更具體地介紹一下圍繞這些廣告的培訓和教育計劃?下半年有哪些我們應該關注的事情,無論是產業會議、KOL、活動、點對點或類似的事情?謝謝。

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Good morning, Andrew. So it's already started in terms of internal training. And the month of August will actually be a heavy month training wise for our organization. We're having regional meetings within our sales organization, pulling them into centralized locations and spending two days of really diving deep into the clinical value proposition and the clinical benefit that these markets are going to provide. The team has been preparing for this for a couple of months now and I will be attending portions of those. So very excited to see kind of where we sit internally from a training standpoint, call it, end of August, beginning of September.

    早安,安德魯。所以內部培訓方面已經開始了。對我們的組織來說,八月其實是一個繁重的訓練月。我們正在銷售組織內召開區域會議,將他們集中到集中地點,並花兩天時間真正深入研究這些市場將提供的臨床價值主張和臨床效益。團隊已經為此準備了幾個月,我將參加其中的部分活動。非常高興看到我們從培訓的角度來看我們內部的情況,稱之為八月底九月初。

  • So those are some internal efforts. Obviously, we're revamping all of our marketing material. Our AVISE CTD report is changing as a result of this. We're taking that opportunity to enhance the way that we provide just even the AVISE, the standard AVISE analytes, but then also these new ones. Our interpretation on that report is changing, and it will be very educational there. There's -- be happy to show and share some of that stuff as it becomes fully mature, but maybe in the next month, 1.5 months, that will occur.

    這些都是一些內部努力。顯然,我們正在修改所有行銷材料。我們的 AVISE CTD 報告因此而改變。我們正在利用這個機會來增強我們提供的方式,甚至提供 AVISE、標準 AVISE 分析物,而且還提供這些新分析物。我們對該報告的解釋正在發生變化,這將非常有教育意義。當它完全成熟時,我們很樂意展示和分享其中的一些東西,但也許在下個月,1.5 個月,這就會發生。

  • As I mentioned, ACRs in the month of November, that's going to be a key date for us. It's mid-November there. We'll have a strong educational campaign. We are already slated to have some presentations there on these topics. And so excited to get that information out there and really start the commercialization of these enhancements.

    正如我所提到的,11 月的 ACR 對我們來說將是一個關鍵日期。那裡已經是十一月中旬了。我們將開展一場強而有力的教育活動。我們已經計劃在那裡就這些主題進行一些演講。非常高興能夠獲得這些資訊並真正開始這些增強功能的商業化。

  • So those are the main things that are occurring and then we'll see, we're also in the midst of publishing a couple of manuscripts, which highlight the studies that we've run, clinical validation, if you will, of these markers. So those will hit the public domain ideally sometime before the end of the year, tough to control publication timelines, but ideally before the end of the year. So you'll see those things at the public domain. And then obviously, we'll see the reaction from physicians probably here manifest in Q1.

    這些是正在發生的主要事情,然後我們會看到,我們也在發表幾份手稿,其中重點介紹了我們已經進行的研究,以及這些標記物的臨床驗證(如果你願意的話) 。因此,這些內容最好在年底之前進入公共領域,很難控制發佈時間表,但最好在年底之前。所以你會在公共領域看到這些東西。顯然,我們會看到醫生的反應可能會在第一季顯現出來。

  • Andrew Brackmann - Analyst

    Andrew Brackmann - Analyst

  • Perfect. That's actually a good segue. It's where I wanted to go next really just around sort of data generation. So it sounds like you've got some the manuscripts coming around validation. But anything that we should be on the lookout in terms of clinical utility studies, how are you thinking about the importance of running those? Thank you.

    完美的。這實際上是一個很好的延續。這就是我下一步想要去的地方,實際上就是圍繞著資料生成。聽起來您已經收到了一些正在驗證的手稿。但是,我們在臨床效用研究方面應該注意什麼,您如何看待進行這些研究的重要性?謝謝。

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • That's a great question. Clinical utility is a key part of reimbursement in this space is something that we're at the heart of our product enhancements and product launches. We have clinical trials set up with folks, and we're in discussions with others taking a look at clinical utility. It will be a little soon to demonstrate clinical utility exactly when we launch these markers, but it is something that we are actively working on and more to come maybe in 2025 as those trials continue to enroll and we start to see the results of some of it.

    這是一個很好的問題。臨床效用是這個領域報銷的關鍵部分,也是我們產品增強和產品發布的核心。我們與人們一起進行了臨床試驗,並且正在與其他人討論臨床實用性。當我們推出這些標記物時,要確切地證明臨床實用性還為時過早,但這是我們正在積極開展的工作,隨著這些試驗的繼續招募,我們可能會在2025 年開展更多工作,而我們開始看到一些研究的結果它。

  • So right now, focus on analytical validation, clinical validation, both of those results from initial readouts are very strong. It’s the reason we’re launching these. And then subsequently, we’ll look to see how clinical behavior is enhanced with the launch of these markers here in ‘25.

    所以現在,重點是分析驗證和臨床驗證,這兩個初步讀數的結果都非常強大。這就是我們推出這些產品的原因。隨後,我們將看看 25 年這些標記物的推出如何增強臨床行為。

  • Andrew Brackmann - Analyst

    Andrew Brackmann - Analyst

  • Great. Thanks.

    偉大的。謝謝。

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Thanks, Andrew.

    謝謝,安德魯。

  • Operator

    Operator

  • Thank you. We've reached the end of the question-and-answer session. I'll now turn the call over to John Aballi for closing remarks.

    謝謝。我們的問答環節已經結束了。現在我將把電話轉給約翰·阿巴利(John Aballi)做總結發言。

  • John Aballi - President, Chief Executive Officer, Director

    John Aballi - President, Chief Executive Officer, Director

  • Great. I want to end by extending a huge thanks to the team at Exagen for executing at a very high level and continuing to trust in the process and buy into the changes we've made at the organization. As we continue to evolve our business, our performance is showcasing the transformation. It's exciting to see. It continues to be exciting to convey, and I look forward to providing our next update in a few months. Thanks all.

    偉大的。最後,我要向 Exagen 團隊表示衷心的感謝,感謝他們以非常高的水平執行任務,並繼續信任流程並支持我們在組織中所做的變革。隨著我們業務的不斷發展,我們的業績正在展示這種轉變。很令人興奮。傳達這一訊息仍然令人興奮,我期待在幾個月後提供我們的下一次更新。謝謝大家。

  • Operator

    Operator

  • This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.

    今天的會議到此結束。此時您可以斷開線路。感謝您的參與。