Certara Inc (CERT) 2025 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Certara second-quarter 2025 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

您好，感謝您的支持。歡迎參加 Certara 2025 年第二季財報電話會議。（操作員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to your first speaker today, David Deuchler, Investor Relations. Please go ahead.

現在，我想將會議交給今天的第一位發言人，投資者關係部的 David Deuchler。請繼續。

Good afternoon, everyone. Thank you all for participating in today's conference call. On the call from Certara, we have William Feehery, Chief Executive Officer; and John Gallagher, Chief Financial Officer. Earlier today's Certara released financial results for the quarter ended June 30, 2025. A copy of the press release is available on the company's website.

大家下午好。感謝大家參加今天的電話會議。在 Certara 的電話會議上，我們採訪了執行長 William Feehery 和財務長 John Gallagher。今天早些時候，Certara 發布了截至 2025 年 6 月 30 日的季度財務業績。新聞稿副本可在該公司網站上查閱。

Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements, and actual results may differ materially from those expressed or implied in the forward-looking statements. Please refer to slide 2 in the accompanying materials for additional information which you define on the company's Investor Relations website.

在我們開始之前，我想提醒您，管理階層將在本次電話會議中發表包含前瞻性陳述的聲明，實際結果可能與前瞻性陳述中表達或暗示的結果有重大差異。有關您在公司投資者關係網站上定義的其他信息，請參閱隨附資料中的幻燈片 2。

In our remarks or responses to questions, management may mention some non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures are available in the most recent earnings press release available on the company's website. Please refer to the reconciliation tables in the company materials for additional information.

在我們的評論或回答問題時，管理階層可能會提到一些非公認會計準則財務指標。這些非 GAAP 財務指標與最直接可比較的 GAAP 指標的對帳表可在公司網站上最新的收益新聞稿中找到。請參閱公司資料中的對帳表以獲取更多資訊。

The conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 6, 2025. Certara disclaims any obligation, except as required by law, to update or revise any financial projections or forward-looking statements whether because of new information, future events or otherwise.

電話會議包含時間敏感訊息，僅截至今天（2025 年 8 月 6 日）的現場直播時準確。除法律要求外，Certara 不承擔任何更新或修改任何財務預測或前瞻性聲明的義務，無論是由於新資訊、未來事件或其他原因。

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

說完這些，我會把電話轉給威廉。

Thank you, David, and good afternoon, everyone. Thank you for joining Certara's second-quarter earnings call. John and I will begin with prepared remarks, and then we will take your questions.

謝謝你，大衛，大家下午好。感謝您參加 Certara 的第二季財報電話會議。約翰和我將先發表準備好的發言，然後回答大家的提問。

Certara's second quarter performance reflected continued strength across the organization as we achieved results that were consistent with our full year outlook in both software and services. Second quarter revenue of $104.6 million, represented 12% year-over-year growth, while second quarter bookings of $112 million, reflected 13% year-over-year growth. Relative to internal expectations, we are pleased with the state of our financial performance and sales funnel as we head into the second half of the year.

Certara 第二季度的業績反映了整個組織的持續強勁成長，我們取得的業績與軟體和服務領域的全年展望一致。第二季營收為 1.046 億美元，年增 12%，第二季預訂金額為 1.12 億美元，年增 13%。相對於內部預期，我們對下半年的財務業績和銷售通路狀況感到滿意。

Across the portfolio, we continue to see strength in high-growth areas such as QST services and our Simcyp software. We have a high degree of visibility into second half software performance based on the mix of renewals in our pipeline, which gives us additional confidence in our full year growth expectations.

在整個投資組合中，我們繼續看到 QST 服務和 Simcyp 軟體等高成長領域的強勁表現。根據我們通路中的續約組合，我們對下半年軟體表現有很高的可見性，這使我們對全年成長預期更有信心。

In services, our commercial team continues to execute in line or ahead of our expectations, delivering 15% bookings growth in 2Q and 10% bookings growth on a trailing 12-month basis, which supports the revenue outlook through the rest of the year. As a result of our strong year-to-date execution, we are reiterating our full year guidance. Across a variety of customer groups, our conversations continue to reflect a mixed spending environment in our various end markets. Large pharma companies remain cautious driven by a rapidly changing geopolitical and macroeconomic environment. Decision-making timelines for our customers have been affected by proposed pharmaceutical tariffs and the potential introduction of a most favored nation pricing algorithm. Among smaller customers, the biotech funding environment has slightly improved, but it remains below trend on a historical basis.

在服務方面，我們的商業團隊繼續按照我們的預期執行或超出我們的預期，第二季度的預訂量增長了 15%，過去 12 個月的預訂量增長了 10%，這支持了今年剩餘時間的收入前景。由於我們今年迄今的強勁執行力，我們重申全年指引。在各種客戶群中，我們的對話持續反映出各個終端市場的混合支出環境。在快速變化的地緣政治和宏觀經濟環境中，大型製藥公司仍保持謹慎態度。擬議的藥品關稅和可能引入的最惠國定價演算法影響了我們客戶的決策時間。對於較小的客戶來說，生技融資環境略有改善，但從歷史角度來看仍低於趨勢水準。

Despite these headwinds, we have been encouraged by persistent interest from customers seeking to expand their use of biosimulation technology, incorporating additional Certara products and services into their development workflows. Throughout the second quarter, our team did an excellent job of remaining in front of key stakeholders and facilitating discussions about how we can further expand existing relationships.

儘管存在這些不利因素，但客戶對擴大生物模擬技術的使用範圍並把更多的 Certara 產品和服務納入到他們的開發工作流程中，這讓我們感到鼓舞。在整個第二季度，我們的團隊出色地與主要利害關係人保持聯繫，並促進了有關如何進一步擴大現有關係的討論。

Now turning to our second quarter commercial performance. In software, we saw strong bookings performance across Tiers 2 and 3, offset by timing-related softness in Tier 1, which remains in line with plan on a year-to-date basis. Software revenue of $46.7 million grew 22% on a reported basis and 9% organically, led by strong growth from Simcyp in addition to $5.1 million of contribution from Chemaxon.

現在談談我們第二季的商業表現。在軟體方面，我們看到 2 級和 3 級市場的預訂量表現強勁，但 1 級市場的預訂量因時間因素而有所疲軟，但與年初至今的計劃相符。軟體收入為 4,670 萬美元，報告成長 22%，有機成長 9%，主要得益於 Simcyp 的強勁成長以及 Chemaxon 的 510 萬美元貢獻。

In services, we saw bookings growth across all three of our customer tiers led by strength in Tier 1 across both biosimulation and regulatory services. Strength in biosimulation services bookings was driven by QST and Simcyp services, while total regulatory bookings also grew nicely during the quarter. Services revenue of $57.9 million grew 5% on a reported basis.

在服務方面，我們看到所有三個客戶層級的預訂量均有所增長，其中，第一層級的生物模擬和監管服務表現強勁。生物模擬服務訂單的強勁成長得益於 QST 和 Simcyp 服務，而本季整體監管訂單也實現了良好成長。服務收入為 5,790 萬美元，年增 5%。

Certara Simcyp reached a significant regulatory milestone earlier this week. We're happy to share that Certara is the first and only company to receive European Medicines Agency, EMA, qualification for a PBPK modeling platform and Simcyp is the only software to hold this designation. The recognition follows a rigorous multiyear collaborative engagement between Certara scientists, technologists, and the EMA. The qualification is a significant milestone for biosimulation, demonstrating the value that regulators place on evidence generated through modeling and simulation approaches, and it will continue to encourage the usage of Simcyp by companies globally.

本週早些時候，Certara Simcyp 達到了一個重要的監管里程碑。我們很高興地告訴大家，Certara 是第一家也是唯一一家獲得歐洲藥品管理局 (EMA) PBPK 建模平台資格的公司，而 Simcyp 是唯一獲得此稱號的軟體。此次認可是 Certara 科學家、技術專家和 EMA 經過多年嚴格合作的結果。此資格認證是生物模擬的一個重要里程碑，表明監管機構重視透過建模和模擬方法產生的證據，並將繼續鼓勵全球公司使用 Simcyp。

Certara is continuing to increase investment in R&D to create our next-generation AI-enabled MIDD platform. This investment started in 2022, before the breakthroughs in GPT AIs were announced when Certara acquired Vyasa.

Certara 正在持續增加研發投入，以打造我們的下一代支援 AI 的 MIDD 平台。這項投資始於 2022 年，早於 Certara 收購 Vyasa 宣布 GPT AI 取得突破之前。

Vyasa brought to Certara the foundational distributed data fabric technology which has become the underpinning of our ability to integrate AI with our modeling technology and data sets. Since then, we have utilized this technology in a number of new AI features in our products and also some new important AI products like co-author.

Vyasa 為 Certara 帶來了基礎分散式資料結構技術，該技術已成為我們將 AI 與建模技術和資料集相結合的能力的基礎。從那時起，我們已將這項技術應用於我們產品中的許多新 AI 功能以及一些新的重要 AI 產品（如共同作者）。

Last week, I was pleased to announce the promotion of Dr. Christopher Bouton, Founder of Vyasa as Certara CTO. Chris is leading the integration of Certara's key MIDD modeling tools into our next-generation AI MIDD platform, which we'll be launching over the next year. We believe that Certara can solidify our leading position in the MIDD with this platform, which will fuse both AI and biosimulation technology to enable our customers to reduce the risk and cost of drug development.

上週，我很高興地宣布 Vyasa 創辦人 Christopher Bouton 博士晉升為 Certara 技術長。Chris 正在領導將 Certara 的關鍵 MIDD 建模工具整合到我們的下一代 AI MIDD 平台中，我們將在明年推出該平台。我們相信，Certara 可以透過該平台鞏固我們在 MIDD 中的領先地位，該平台將融合人工智慧和生物模擬技術，使我們的客戶能夠降低藥物開發的風險和成本。

The next step in the creation of this platform will be the release this fall of Certara IQ, an AI-enabled QST software solution that includes an intuitive model building interface and several prevalidated QSP models. As you will recall, QSP is one of the fastest-growing markets within model inform drug development, and we have the largest group globally serving these customers. Our services team will adopt Certara IQ as their preferred platform for executing QSP products, leveraging cutting-edge features and modeling capabilities.

創建該平台的下一步將是今年秋季發布 Certara IQ，這是一款支援 AI 的 QST 軟體解決方案，其中包括直覺的模型建立介面和幾個預先驗證的 QSP 模型。您可能還記得，QSP 是模型資訊藥物開發領域成長最快的市場之一，我們擁有全球最大的為這些客戶服務的團隊。我們的服務團隊將採用 Certara IQ 作為執行 QSP 產品的首選平台，利用其尖端功能和建模能力。

With Certara IQ, customers will have one unified QSP platform to reference in collaboration with peers, Certara and regulators. The product will be based in the cloud, allowing for high-performance simulation and analysis work at faster speeds. We believe this product launch is a critical step in growing the market for QSP solutions by democratizing access to modeling capabilities across our customers, which should ultimately lead to more QSP use in clinical development. The product is currently in an early access phase with several customers, and we expect to announce a full commercial launch at some point in the fourth quarter.

透過 Certara IQ，客戶將擁有一個統一的 QSP 平台，可供同業、Certara 和監管機構參考。該產品將基於雲端，能夠以更快的速度實現高效能模擬和分析工作。我們相信，透過讓客戶能夠民主化地使用建模功能，該產品的發布是擴大 QSP 解決方案市場的關鍵一步，最終將導致 QSP 在臨床開發中得到更多的應用。該產品目前正處於早期試用階段，有多個客戶正在試用，我們預計將在第四季度的某個時候宣布全面商業發布。

While we are on the subject of QSP, we received an update on our QSP collaboration with IGI, which was published in Nature Cancer last fall. Our QSP team worked with IGI to optimize the first-in-human dose of ISP 2001, resulting in a clinical starting dose that was 50 to 100 fold over the conventional starting dose, and that reduced the need for animal testing. These predictions were validated by first-in-human trial results that were presented at AACR this year and ISP 2001 was granted a Fast Track designation for the treatment of relapsed refractory myeloma patients in May.

當我們討論 QSP 時，我們收到了有關我們與 IGI 合作的 QSP 的最新消息，該消息於去年秋天發表在《自然癌症》雜誌上。我們的 QSP 團隊與 IGI 合作優化了 ISP 2001 的首次人體劑量，使臨床起始劑量達到傳統起始劑量的 50 到 100 倍，並減少了動物試驗的需要。這些預測已得到今年 AACR 上公佈的首次人體試驗結果的驗證，並且 ISP 2001 於 5 月獲得了治療復發難治性骨髓瘤患者的快速通道資格。

We are thrilled by the work of our QSP team and the outcome of these studies for all key stakeholders, showcasing the impact that QSP could have in accelerating trial time lines and accelerating the delivery of treatments to patients in need. In addition, excitement about new approach methodologies and particularly model-informed drug development has grown in the wake of the FDA's guidance to phase out animal testing for monoclonal antibodies.

我們對 QSP 團隊的工作以及這些研究對所有主要利益相關者的成果感到非常高興，展示了 QSP 在加快試驗時間表和加快向有需要的患者提供治療方面可能產生的影響。此外，隨著 FDA 指導逐步淘汰單株抗體動物試驗，人們對新方法、特別是基於模型的藥物開發的興趣日益濃厚。

While it's still too early to provide a precise estimate of the broader opportunity, we do view it as a multibillion-dollar addressable market over the next 10 years. We are excited to share that our QSP and broader Simcyp businesses have begun to recognize bookings and revenue associated with the replacement of animal testing.

雖然現在對更廣泛的機會做出精確估計還為時過早，但我們確實認為在未來 10 年內它是一個價值數十億美元的潛在市場。我們很高興地告訴大家，我們的 QSP 和更廣泛的 Simcyp 業務已經開始確認與替代動物測試相關的預訂和收入。

Roughly 50% of our new QSP projects this year have been for monoclonal antibody therapies, which is a testament to Certara's competitive positioning as the leader in QSP of services, as well as the growing momentum of (inaudible) use in clinical development processes. Our acquisition of Applied Biomass in late 2003, and the subsequent combination of ourtwo QSP teams has proven timely and is becoming an increasingly important component of our overall growth.

我們今年大約 50% 的新 QSP 計畫都是單株抗體療法，證明了 Certara 作為服務 QSP 領導者的競爭地位，以及（聽不清楚）在臨床開發過程中使用的成長勢頭。我們在 2003 年底收購了 Applied Biomass，隨後合併了兩個 QSP 團隊，事實證明這項收購非常及時，並且正在成為我們整體成長中越來越重要的組成部分。

Now shifting towards some other product-related updates. During the quarter, we released version 8.6 of our Phoenix PK/PD platform, following months of development and incorporating feedback from key stakeholders. New enhancements included in the update were improved speed and efficiency of NCA setup, data preparation, and the speed of non-linear mixed-effect algorithms for population pharmacokinetics.

現在轉向一些其他與產品相關的更新。在本季度，經過數月的開發並吸收了主要利害關係人的回饋，我們發布了 Phoenix PK/PD 平台 8.6 版本。更新中包含的新增強功能包括提高 NCA 設定、資料準備的速度和效率以及群體藥物動力學非線性混合效應演算法的速度。

As we have discussed in the past, this product has been made available through the Certara Cloud, offering faster performance with lower back-end IT costs for our customers. Initial feedback from our users has been positive, and we look forward to collaborating with them to drive further improvements to the Phoenix platform.

正如我們過去所討論過的，該產品已透過 Certara Cloud 提供，為我們的客戶提供更快的效能和更低的後端 IT 成本。我們用戶的初步回饋是正面的，我們期待與他們合作，推動 Phoenix 平台的進一步改進。

Another key focus area for investment over the past several quarters was our Pinnacle 21 product suite, which is core to the data component of the software business. Following the acquisition of Prometic in late 2023, our team began to integrate Pinnacle 21 and Prometic data standardization capabilities, seeking to improve our customers' clinical data workflows and time lines.

過去幾季投資的另一個重點領域是我們的 Pinnacle 21 產品套件，它是軟體業務資料組件的核心。在 2023 年底收購 Prometic 之後，我們的團隊開始整合 Pinnacle 21 和 Prometic 資料標準化功能，力求改善客戶的臨床資料工作流程和時間軸。

In early July, we were pleased to announce a new collaboration with Merck, expanding their use of Pinnacle 21 and broadly incorporating new integrated data standardization capabilities. This collaboration helped us build upon our long-standing relationship with Merck, which is an example of the type of engagement that Certara is striving to build across our customer base.

7 月初，我們很高興宣布與默克公司建立新的合作關係，擴大他們對 Pinnacle 21 的使用，並廣泛納入新的整合式資料標準化功能。此次合作幫助我們鞏固了與默克的長期合作關係，這也是 Certara 努力在客戶群中建立的合作類型的一個例子。

Our commercial team remains focused on identifying opportunities to form stronger partnerships with customers, both through the expansion of existing capabilities to more seats and expansion of new products and services. As we add to our portfolio organically and inorganically, our land and expand commercial strategy remains top of mind.

我們的商業團隊始終致力於尋找機會與客戶建立更牢固的合作夥伴關係，透過將現有能力擴展到更多席位以及擴展新產品和服務。隨著我們透過有機和無機方式擴大投資組合，我們的土地和擴張商業策略仍然是首要考慮因素。

Now before handing things over to John, I wanted to provide an update on the strategic review of our regulatory business. Regulatory bookings have continued to grow nicely through the quarter, and we continue to value the business given the profitability and cash flows that it generates.

現在，在將事情交給約翰之前，我想提供有關我們監管業務策略審查的最新情況。本季監管預訂量持續良好成長，鑑於該業務產生的獲利能力和現金流，我們繼續重視該業務。

Over the past several months, we have continued to make good progress in our review. However, this process has taken longer than we expected, which we attribute in part to the unprecedented nature of geopolitical and macroeconomic uncertainty that has taken place since the beginning of the year. With that said, we have maintained an active dialogue with several interested external parties with discussions progressing beyond the initial phases of diligence.

過去幾個月，我們的審查工作持續取得良好進展。然而，這個過程比我們預期的要長，部分原因是今年年初以來地緣政治和宏觀經濟的不確定性是前所未有的。話雖如此，我們一直與多個感興趣的外部方保持積極的對話，討論已經超出了盡職調查的初始階段。

We hope to be able to provide a more substantive update before the end of 2025. To close, we are pleased with our second quarter performance, and we are confident in our financial outlook for the remainder of the year. Our guidance is supported by solid bookings trends in services and high visibility into second half renewal dynamics in software. Customer interest in Model Inform drug development continues to grow stronger each quarter, supporting our growth strategy and validating the investments we are making in our business. We look forward to continued success and momentum during the second half of 2025.

我們希望能夠在 2025 年底前提供更實質的更新。最後，我們對第二季的業績感到滿意，並對今年剩餘時間的財務前景充滿信心。我們的指導得到了服務領域穩健的預訂趨勢和軟體領域下半年更新動態的高度可見性的支持。客戶對 Model Inform 藥物開發的興趣每季都在不斷增長，這支持了我們的成長策略並驗證了我們在業務上所做的投資。我們期待 2025 年下半年繼續取得成功並保持強勁勢頭。

With that, I will hand things over to John Gallagher to discuss our financial results in more detail.

說完這些，我將把事情交給約翰·加拉格爾來更詳細地討論我們的財務結果。

Thank you, William. Hello, everyone. Total revenue for the three months ended June 30, 2025, and was $104.6 million, representing year-over-year growth of 12% on a reported basis and 10% on a constant currency basis. Total bookings in the second quarter were $112 million, which increased 13% from the prior year period on a reported basis. Trailing 12-month bookings were $470.8 million, increasing 15% on a reported basis.

謝謝你，威廉。大家好。截至 2025 年 6 月 30 日的三個月總營收為 1.046 億美元，以報告基礎計算年增 12%，以固定匯率計算成長 10%。第二季的總預訂額為 1.12 億美元，據報道比去年同期成長了 13%。過去 12 個月的預訂金額為 4.708 億美元，年增 15%。

Excluding Chemaxon, total company organic bookings growth was 8% and compared with the second quarter last year. Software revenue was $46.7 million in the second quarter, which increased 22% over the prior year period on a reported basis, and 20% on a constant currency basis.

不包括 Chemaxon，該公司整體有機預訂量與去年第二季度相比增長了 8%。第二季軟體營收為 4,670 萬美元，以報告基礎計算比去年同期成長 22%，以固定匯率計算成長 20%。

Organic growth was 9% in the quarter, driven by strong growth from Simcyp. Chemaxon contributed $5.1 million to our reported revenue, which was in line with our expectations. Ratable and subscription revenue accounted for 60% of second quarter software revenues or 64% when excluding Chemaxon, slightly down from 65% in the prior year period.

本季有機成長率為 9%，主要得益於 Simcyp 的強勁成長。Chemaxon 為我們報告的收入貢獻了 510 萬美元，這符合我們的預期。按比例分配和訂閱收入佔第二季軟體收入的 60%，若不包括 Chemaxon，則為 64%，略低於去年同期的 65%。

Software bookings were $46.6 million in the second quarter, which increased 11% from the prior year period. Second quarter bookings included $5.2 million of Chemaxon bookings. Trailing 12-month software bookings were $181.9 million, up 25% year over year. The software net retention rate was 107.6% in the quarter, consistent with our full year plan.

第二季軟體訂單金額為 4,660 萬美元，比去年同期成長 11%。第二季的訂單包括價值 520 萬美元的 Chemaxon 訂單。過去 12 個月的軟體訂單金額為 1.819 億美元，較去年同期成長 25%。本季軟體淨留存率為107.6%，與我們的全年計畫一致。

Looking at our software bookings performance by Tier, we saw strong performance in Tier 2 and 3 driven by continued adoption of our software. In Tier 1, we saw some timing-related slowness due to renewals, which we expect to normalize in the second half of the year.

從各級來看我們的軟體預訂表現，我們發現第 2 層和第 3 層表現強勁，這得益於我們軟體的持續採用。在第 1 層，我們看到由於續訂而導致的一些與時間相關的緩慢現象，我們預計這種情況將在下半年恢復正常。

Now turning to services revenue, which was $57.9 million in the second quarter, up 5% versus the prior year period on a reported basis and 4% on a constant currency basis. We saw a strong performance from our QSP and Simcyp services businesses in the quarter, which was partially offset by softness in regulatory services. Technology-driven services bookings in the second quarter were $65.4 million, which increased 15% from prior year period. TTM services bookings were $288.9 million, up 10% as compared to the prior year.

現在談服務收入，第二季服務收入為 5,790 萬美元，以報告基礎計算比去年同期成長 5%，以固定匯率計算成長 4%。本季度，我們的 QSP 和 Simcyp 服務業務表現強勁，但監管服務的疲軟部分抵消了這一表現。第二季技術驅動服務訂單金額為 6,540 萬美元，比去年同期成長 15%。TTM 服務預訂金額為 2.889 億美元，比上年增長 10%。

During the quarter, we saw an improved demand for our biosimulation services with bookings growth across all 3 of our customer tiers. We were also encouraged by regulatory writing bookings, which grew mid-single digits versus the second quarter of 2024.

在本季度，我們發現生物模擬服務的需求增加，所有三個層級的客戶預訂量均有所增加。監管寫作訂單量也令我們感到鼓舞，與 2024 年第二季度相比，該訂單量增長了中等個位數。

Total cost of revenue for the second quarter of 2025 was $40.7 million, an increase of $39.8 million in the second quarter of 2024, primarily due to higher software amortization expense offset by lower stock-based compensation.

2025 年第二季的總收入成本為 4,070 萬美元，比 2024 年第二季增加了 3,980 萬美元，主要原因是軟體攤提費用增加被股票薪資減少所抵銷。

Total operating expenses for the second quarter of 2025 were $54.3 million, a decrease from $62.5 million in the second quarter of 2024, primarily due to an $8.5 million decrease in the change in fair value of a contingent consideration, which was offset by higher sales and marketing expense and intangible asset amortization.

2025 年第二季的總營運費用為 5,430 萬美元，較 2024 年第二季的 6,250 萬美元有所下降，主要原因是或有對價的公允價值變動減少了 850 萬美元，但被更高的銷售和行銷費用以及無形資產攤銷所抵銷。

Adjusted EBITDA for the second quarter of 2025 was $31.9 million, an increase from $26.3 million in the second quarter of 2024. Adjusted EBITDA margin in the quarter was 31%. As Bill mentioned earlier, we are executing on our investment plans this year and have begun hiring additional software developers in the second quarter, which will continue through the second half of the year.

2025 年第二季調整後 EBITDA 為 3,190 萬美元，高於 2024 年第二季的 2,630 萬美元。本季調整後的 EBITDA 利潤率為 31%。正如比爾之前提到的，我們正在執行今年的投資計劃，並已在第二季度開始招募更多的軟體開發人員，這將持續到今年下半年。

Total expenditure on R&D during 2Q, including capitalized spend is growing year-on-year as a result of these investments. Wrapping up the income statement. Net loss for the second quarter of 2025 was $2 million compared to a net loss of $12.6 million in the second quarter of 2024.

由於這些投資，第二季研發總支出（包括資本化支出）較去年同期成長。總結損益表。2025 年第二季淨虧損為 200 萬美元，而 2024 年第二季淨虧損為 1,260 萬美元。

Reported adjusted net income for the second quarter of 2025 was $11.6 million compared to $11.4 million for the second quarter of 2024. Diluted loss per share for the second quarter of 2025 was $0.01 compared to a loss of $0.08 per share in the second quarter of last year.

2025 年第二季的調整後淨收入為 1,160 萬美元，而 2024 年第二季為 1,140 萬美元。2025 年第二季每股攤薄虧損為 0.01 美元，去年第二季每股虧損為 0.08 美元。

Adjusted diluted earnings per share for the second quarter of 2025 was $0.07, same as the second quarter of last year. Moving to the balance sheet. We finished the quarter with $162.3 million in cash and cash equivalents. As of June 30, 2025, we had $297 million of outstanding borrowings on our term loan and full availability under our revolving credit facility.

2025 年第二季調整後每股攤薄收益為 0.07 美元，與去年第二季相同。轉到資產負債表。本季末我們的現金和現金等價物為 1.623 億美元。截至 2025 年 6 月 30 日，我們的定期貸款未償還借款為 2.97 億美元，且我們的循環信貸額度已全部可用。

Earlier this year, our Board authorized a $100 million share repurchase program. As of today, we have purchased a total of $25 million in stock, all of which was during the second quarter. We are reiterating our guidance today as follows: we expect total revenue in the range of $415 million to $425 million, representing growth of 8% to 10% compared to 2024.

今年早些時候，我們的董事會批准了一項 1 億美元的股票回購計畫。截至今天，我們已購買了總計 2,500 萬美元的股票，全部都是在第二季購買的。我們今天重申我們的指導意見：我們預計總收入在 4.15 億美元至 4.25 億美元之間，與 2024 年相比增長 8% 至 10%。

We expect Chemaxon to contribute software revenue of $23 million to $25 million. We expect adjusted EBITDA margins between 30% to 32%, similar to our guidance last year, we anticipate a higher EBITDA margin at the lower end of our revenue guidance and a lower EBITDA margin at the higher end of our revenue guidance. This will be driven by discretionary investments in R&D, which will be managed carefully based on the timing of new product launches and business performance in the second half.

我們預計 Chemaxon 將貢獻 2,300 萬至 2,500 萬美元的軟體收入。我們預計調整後的 EBITDA 利潤率在 30% 至 32% 之間，與我們去年的指導類似，我們預計收入指導下限的 EBITDA 利潤率會較高，而收入指導上限的 EBITDA 利潤率會較低。這將由研發方面的自主投資推動，並將根據下半年新產品發布的時間和業務表現進行謹慎管理。

We expect adjusted EPS in the range of $0.42 to $0.46 per share fully diluted shares in the range of $162 million to $164 million and a tax rate in the range of 25% to 30%.

我們預計調整後的每股盈餘在 0.42 美元至 0.46 美元之間，全面攤薄後的每股盈餘在 1.62 億美元至 1.64 億美元之間，稅率在 25% 至 30% 之間。

I will now turn the call back over to our CEO, William Feehery for closing remarks.

現在我將把電話轉回給我們的執行長威廉費赫里 (William Feehery) 作結束語。

Thank you, John. To summarize our message today, we are pleased with the many exciting developments of Certara in the second quarter. and we remain focused on executing our growth and profitability goals in 2025. We continue to make good progress on the software development front, and I am looking forward to sharing further updates following some new product launches in the fall.

謝謝你，約翰。總結我們今天的信息，我們對 Certara 在第二季度取得的許多令人興奮的發展感到高興。我們仍專注於實現 2025 年的成長和獲利目標。我們在軟體開發方面繼續取得良好進展，我期待在秋季推出一些新產品後分享進一步的更新。

Operator, can you please open the line for questions?

接線員，您能開通熱線來回答問題嗎？

(Operator Instructions) Joe Vruwink, Baird.

（操作員指示）Joe Vruwink，Baird。

Just a quick clarification. Multibillion dollar addressable market opportunity you cited around NAMs. Is that incremental to the low single-digit billion TAM you traditionally have discussed for biosimulation software?

只需簡單澄清一下。您提到的 NAM 周圍有數十億美元的潛在市場機會。這是否對您傳統上討論的生物模擬軟體的低個位元數十億 TAM 有所增量？

Yeah. We're looking at that as what would be additional opportunity, Joe, based on trying to ring-fence what we think the long-term opportunity is for NAM.

是的。喬，我們認為這將是額外的機會，因為我們試圖確定我們認為的 NAM 的長期機會。

Okay. That's great. And then I thought it was interesting. Certara had a webinar during the quarter and during the webinar they ask respondents just what they're currently using around NAMs and I think 40% cited nothing. So that seems like a good opportunity.

好的。那太棒了。然後我覺得很有趣。Certara 在本季度舉辦了一次網路研討會，在網路研討會期間，他們詢問受訪者目前在 NAM 中使用什麼，我認為 40% 的人沒有提到任何內容。這看起來是個好機會。

But 30% cited PD/PK modeling, 12% with QSP. I guess I would have expected the QSP responses to be a lot higher. What's kind of your interpretation of just how kind of the thinking is settling out does Certara need to do more marketing on their part to educate customers around maybe the best course of action? Just how are you seeing kind of customer decision-making change now that we're a few months further in.

但 30% 引用了 PD/PK 模型，12% 引用了 QSP。我想我應該期望 QSP 的回應率會高得多。您如何看待 Certara 的想法？是否需要進行更多行銷工作來向客戶介紹最佳行動方案？幾個月過去了，您認為客戶決策發生了什麼樣的變化？

So Joe, as it relates to QSP, QSP is one of the bright spots on the quarter for us. So I think that those results would also surprise us as far as that's a pocket of the business along with Simcyp, where we would see additional opportunity going forward.

所以喬，就 QSP 而言，QSP 是我們本季的亮點之一。因此，我認為這些結果也會讓我們感到驚訝，因為這是與 Simcyp 一起開展的業務的一部分，我們將在未來看到更多機會。

So that QSP is a growing area in general. And our combination of our existing practice along with applied biomass makes us the market leader in that spot. So I would expect that ratio that you cited to grow into the future.

因此 QSP 總體來說是一個正在成長的領域。我們將現有的實踐與應用生物質結合，使我們成為該領域的市場領導者。所以我預計您提到的這個比例未來會成長。

Yes, Joe, I think the other thing that we'll be aware of, it's still pretty early days in terms of the markets thinking about what this announcement means and how it's going to play out as drug programs move forward. The reality is QSP and PD/PK are often quite closely linked. And so I think people may answer the question a little bit differently depending on sort of what they're more familiar with when they go in.

是的，喬，我認為我們要意識到的另一件事是，就市場思考這一聲明意味著什麼以及它將如何隨著藥物計劃的推進而發揮作用而言，現在還為時過早。事實是，QSP 和 PD/PK 往往緊密相關。因此我認為人們可能會根據他們所熟悉的內容對這個問題做出稍微不同的回答。

QSP is sort of a newer branch of model-informed drug development. And so the number that you cited doesn't really concern us, obviously, we're pretty big in both of them. But I think it's -- the way I think about it is as up to 70% of people that are using technologies that we're pretty good in.

QSP 是一種模型知情藥物開發的新分支。所以你引用的數字其實與我們無關，顯然，我們在這兩方面都相當大。但我認為——我認為多達 70% 的人正在使用我們非常擅長的技術。

Luke Sergott, Barclays.

巴克萊銀行的盧克‧塞戈特 (Luke Sergott)。

Hi, guys. This is Andre Prozesky on for Luke. I was wondering if you could give any color on the demand drivers for software versus services bookings? We would think that the services booking strength is like a better leading indicator of future spend and adoption. So it would be great to get your sense of this.

嗨，大家好。我是安德烈‧普羅澤斯基 (Andre Prozesky)，代替路克 (Luke)。我想知道您是否可以詳細說明軟體與服務預訂的需求驅動因素？我們認為服務預訂實力是未來支出和採用的更好的領先指標。所以，如果能了解自己的感受就太好了。

Yeah. I think it's a good question. We don't -- I think that might not be quite the right way to look at it. I think the demand drivers are software, to some extent, companies need the software as part of the R&D infrastructure, so that continues. But we have also put quite a bit of R&D resources over the last periods into new products, which is driving some of that demand there.

是的。我認為這是個好問題。我們不——我認為這可能不是看待這個問題的正確方式。我認為需求驅動因素是軟體，在某種程度上，公司需要軟體作為研發基礎設施的一部分，所以這種情況會持續下去。但我們在過去一段時間也投入了大量研發資源用於新產品，這推動了那裡的部分需求。

Services, it's come back nicely in the quarter, particularly compared with where we were last year. I think there are several things going on there.

本季服務業表現良好，特別是與去年同期相比。我認為那裡發生了幾件事。

One of them has been particularly high demand for QSP services, which is kind of a new growing area as I talked before, second piece has been the linkage of the services to some of the software that I just talked about, the people are buying. So -- we talk about software and services as separate lines, but in fact, they're often quite closely intertwined when we're actually making sales to customers, and so the one drives the other.

其中之一是 QSP 服務的需求特別高，正如我之前提到的，這是一個新興的成長領域，其次是這些服務與我剛才提到的人們正在購買的一些軟體之間的聯繫。因此，我們將軟體和服務作為獨立的產品線來討論，但事實上，當我們真正向客戶銷售產品時，它們往往緊密地交織在一起，因此一個產品會驅動另一個產品。

All right. That is helpful. One quick follow-up. Can you share a little bit more on the dynamics that you saw across customer peers? The biggest difference is between Tier 1 behavior versus Tier 2 and 3, particularly on the software side?

好的。這很有幫助。一次快速跟進。您能否分享更多在客戶同行中看到的動態？最大的差異在於第 1 層行為與第 2 層和第 3 層行為之間，特別是在軟體方面？

Yeah, sure. So we did see Tier 1 software, as you saw on the chart, was impacted by timing of renewals. But as we look at the full year basis and in the second half, we have high confidence and good visibility into being able to achieve those renewals. So that was the one spot on the customer tiering to call out. But then as you look at Tier 3, despite the funding environment, then we've had strong performance on both software and services in Tier 3.

是的，當然。因此，正如您在圖表中看到的那樣，我們確實看到 Tier 1 軟體受到續訂時間的影響。但當我們展望全年和下半年時，我們對實現這些續約充滿信心，並且前景光明。所以這是客戶層級中需要關注的點。但當你看第 3 層時，儘管融資環境不佳，但我們在第 3 層的軟體和服務方面都表現強勁。

So we've been pleased with that. And we had a particular -- as Bill mentioned, we had a particularly strong quarter on services, both biosim services on the Tier 1 side that both Biosim services and in Reg that was that was helping our overall growth rate there.

因此我們對此感到高興。正如比爾所提到的那樣，我們有一個特別的——我們在服務方面有一個特別強勁的季度，包括一級生物類似藥服務，以及註冊服務，這都有助於我們在那裡的整體成長率。

Jeff Garro, Stephens.

傑夫加羅、史蒂芬斯。

Yes. I wanted to ask about the new AI MIDD platform. Curious if you could provide any more detail on how we should think of the glide path for customers as they might adopt that new platform in the future? More specifically, does the -- does the delivery model or economics between you guys and customers look any different? And lastly, there, any concern over potentially pushing out demand ahead of an exciting new product launch?

是的。我想詢問有關新的 AI MIDD 平台。好奇您是否可以提供更多細節，說明我們應該如何考慮客戶未來可能採用的新平台的滑行路徑？更具體地說，你們和客戶之間的交付模式或經濟狀況有什麼不同嗎？最後，是否有人擔心在令人興奮的新產品發布之前可能會推高需求？

Okay. Yes. Thank you, Jeff. Appreciate the question. So several questions there.

好的。是的。謝謝你，傑夫。感謝你的提問。這裡有幾個問題。

Look, we're creating -- we believe that we have the industry-leading technology around biosimulation. And as I said in the call, we've made some very strategic acquisitions in the AI area. The opportunity there is to create a bigger platform that unites a number of our software solutions that work in different areas of drug development into one platform, so that drugs can be optimized according to multi parameters.

看，我們正在創造——我們相信我們擁有業界領先的生物模擬技術。正如我在電話中所說，我們在人工智慧領域進行了一些非常具有戰略意義的收購。這裡的機會是創建一個更大的平台，將我們在藥物開發不同領域的許多軟體解決方案整合到一個平台中，以便根據多種參數對藥物進行最佳化。

And basically, our customers can make a better decision about which molecules to bring forward. We're really excited about this. We think that there's a very significant opportunity for the company. And frankly, for our customers to make much better decisions on which drugs to bring forward, that's an opportunity here.

基本上，我們的客戶可以更好地決定採用哪種分子。我們對此感到非常興奮。我們認為這對公司來說是一個非常重大的機會。坦白說，對於我們的客戶來說，這是一個機會，可以更好地決定推出哪種藥物。

And the reason we highlighted it now is not so much to kind of preannounce the product, but we are spending a fair amount of R&D to produce this. We've got a plan to launch this over the next year, as I said. I'm not particularly worried about your concern about customers kind of waiting it out.

我們現在強調這一點的原因並不是為了預先宣布產品，而是我們投入了大量的研發資金來生產它。正如我所說，我們計劃在明年推出這項計劃。我並不特別擔心您對客戶等待的擔憂。

Most of our customers are pretty highly interested in using our existing products on their current drug development products. It's become -- for a lot of people, really part of the standard way that you do some of the key technical parts in MIDD. So I don't think we'll see people pause that.

我們的大多數客戶對在他們目前的藥物開發產品中使用我們現有的產品非常感興趣。對許多人來說，它已經成為 MIDD 中某些關鍵技術部分的標準方法的一部分。所以我不認為我們會看見人們暫停這一做法。

This is going to be a new product that's going to be over on top of what we sell today. It's got capabilities that are beyond what we have today. Like a lot of companies, the advent of the AI advances that have happened recently have kind of changed the game in terms of what's possible, and we're going to implement that in. So stay tuned.

這將會是一款新產品，其性能將超越我們目前銷售的產品。它擁有超越我們今天所擁有的能力。與許多公司一樣，最近人工智慧的進步在某種程度上改變了遊戲規則，我們將實現這一點。敬請關注。

We haven't fully announced the product. The first part is -- the first part, however, is in fact being launched in Q4 and is in the hands of customers, but there'll be more to that as we go forward over the next year.

我們尚未全面發布該產品。第一部分是 - 然而，第一部分實際上是在第四季度推出並已交到客戶手中，但隨著我們明年的進展，還會有更多內容。

Great. Appreciate that. Really helpful. And maybe to kind of translate some of the key themes there to the financial model, not just this new platform, but you've had CoAuthor release kind of last year and growing this year, you have regular releases of your existing products and some other new ones as well. I just want to get your viewpoint on whether product launches alone are sufficient to drive organic growth out of the -- the low single-digit to mid-single-digit range that the company has been in the last few years?

偉大的。非常感謝。真的很有幫助。也許可以將其中的一些關鍵主題轉化為財務模型，不僅僅是這個新平台，而且您去年已經發布了 CoAuthor，並且今年還在不斷發展，您定期發布現有產品以及其他一些新產品。我只是想聽聽您的觀點：單靠產品發布是否足以推動公司實現有機成長，使其擺脫過去幾年一直保持的低個位數到中個位數的區間？

Or if you really do need a better macro environment on top of that?

還是您真的需要一個更好的宏觀環境？

Yes. Thanks for the question. While we would love a better macroeconomic environment, we are not planning on that, and we're not dependent on that. We believe that the company is in a very unique and valuable spot where it's kind of a combination of maturity of technology and understanding by a lot of the industry and how to use this and acceptance by the regulators. All of them are coming together in a good way at the same time.

是的。謝謝你的提問。雖然我們希望有一個更好的宏觀經濟環境，但我們並沒有計劃這樣做，而且我們也不依賴於此。我們相信，該公司處於一個非常獨特和有價值的位置，它結合了技術的成熟度、業內許多公司對如何使用它的理解以及監管機構的接受度。他們都以一種好的方式同時走到了一起。

And so this is a good time for us to expand our product suite because the possibilities of what we can do are expanding, but we don't need any kind of recovery of the market in order to deliver the results that we're expecting. Now at some point, markets go up and markets go down, some markets will go up, and that will be great, but that's not necessary for our model.

因此，現在是我們擴展產品套件的好時機，因為我們可以做的事情的可能性正在不斷擴大，但我們不需要任何形式的市場復甦就能實現我們期望的結果。現在，在某個時候，市場會上漲，市場會下跌，一些市場會上漲，這將是件好事，但這對我們的模型來說不是必需的。

Michael Cherny, Leerink.

邁克爾·切爾尼（Michael Cherny），Leerink。

Great. This is Dan Clark on for Mike. Just had a question on the EMA qualification for Simcyp. I know this just came out, but how are you thinking about that in terms of differentiating your product, any early customer feedback on receiving that would be great to hear?

偉大的。我是丹‧克拉克 (Dan Clark)，代替麥克 (Mike)。我只是想問一下關於 Simcyp 的 EMA 資格問題。我知道這剛剛發布，但是您如何考慮從產品差異化的角度來看待這個問題，如果您能聽到任何早期的客戶回饋，您會很高興嗎？

Yes. Thanks for the question. I think that's been a real accomplishment by our teams. Our teams seen both at the EMA and Certara. We've been working on this for a better part of two years right now to get this qualification. This is a significant -- the way I would explain this is the MA, like other regulatory agencies has accepted the use of Simcyp in drug applications for some time now. However, the EMA really consists of 27 member nations, and there was no particular qualification of any product there.

是的。謝謝你的提問。我認為這是我們團隊的真正成就。我們的團隊在 EMA 和 Certara 都進行了亮相。為了獲得這個資格，我們已經努力了將近兩年。這是一件意義重大的事——我解釋這一點的方式是，MA 和其他監管機構一樣，已經接受 Simcyp 在藥物申請中的使用一段時間了。然而，EMA 實際上由 27 個成員國組成，並且沒有對任何產品進行特定的資格認證。

So for a lot of our customers, it would depend a little bit on what reviewer you got and what questions they asked and that added time and some uncertainty to the overall process. So reviewers reasonably want to know what's in the models and they want to go qualify it.

因此，對於我們的許多客戶來說，這在一定程度上取決於審閱者是誰以及他們提出了哪些問題，這會增加整個流程的時間和不確定性。因此，審閱者有理由想知道模型中的內容，並希望對其進行驗證。

What this does is that it basically provides a prequalification. So the EMA is effectively saying that Simcyp has been -- all of the underpinnings of Simcyp have been explained and examined and you don't need to do that an approver does not need to do that again in the middle of a drug application. So no one else has achieved this. It's certainly not easy to do the -- I mean it was a really expensive review. And it's not easy to get there. But for our customers, this adds two things.

這樣做的目的是，基本上提供資格預審。因此，EMA 實際上是在說，Simcyp 的所有基礎都已經被解釋和審查，你不需要這樣做，審批者也不需要再在藥物申請過程中這樣做。所以沒有其他人實現過這個目標。這當然不是一件容易的事——我的意思是，這是一次非常昂貴的審查。但要達到這個目標並不容易。但對我們的客戶來說，這增加了兩件事。

I think one is it's kind of a sign of what the regulators think about the software. So they've looked hard at it and accepted it. And the second one is just from a practical standpoint, it ups the consistency of what you can expect when you go into a review process because you don't have to worry about what questions you might get about the underpinnings of Simcyp, that's already kind of taken care of before we've gotten there and it just makes it a whole lot easier to use the software in the review process and to expect consistent results.

我認為，一方面，這是監管機構對該軟體的看法的體現。所以他們認真考慮了這個問題並接受了它。第二個是從實際角度來看的，它提高了您在進入審查過程時可以期待的一致性，因為您不必擔心您可能會遇到有關 Simcyp 基礎知識的問題，這些問題在我們進入審查過程之前就已經得到解決了，這使得在審查過程中使用該軟體變得更加容易，並且可以期待一致的結果。

Kyle Crews, UBS.

瑞銀集團的凱爾克魯斯（Kyle Crews）。

The software bookings declined organically, but it sounds like it's related to a timing issue with Tier 1 customers where you have more visibility into 2H.

軟體預訂量自然下降，但聽起來這與一級客戶的時間問題有關，因為一級客戶對下半年有更高的了解。

Beyond 2H and given kind of a heightened visibility in future orders, could you provide early framing thoughts on 2026 relating to the headwinds with Pharmatears potential MFN and a potential reduction in pharma R&D spend offset by the continued regulatory push for model and form drug development and if you expect growth to accelerate into 2026 and how much and any early qualitative planning thoughts there?

除了下半年之外，考慮到未來訂單的可見性有所提高，您能否提供關於 2026 年的早期框架想法，涉及 Pharmatears 潛在最惠國待遇和製藥研發支出的潛在減少，但被持續的監管推動以抵消對模型和形成藥物開發的負面影響，如果您預計增長將在 2026 年加速，那麼速度會是多少，以及有什麼早期的定性？

Kyle, yes. I think the right way to think about this is in terms of the investments that we're making in R&D and the product launches that Bill has been referring to and the expectation that we don't rely on or expect the end market environment to necessarily improve in the near term, but we do intend to grow the business in the face of that.

凱爾，是的。我認為正確的思考方式是，正如比爾所提到的，我們在研發和產品發布方面進行的投資，以及我們不依賴或期望終端市場環境在短期內必然會改善的預期，但我們確實打算在這種情況下發展業務。

And so as we look at products that we've rolled out recently, we look at the strength of the existing platforms of call out Simcyp as a key highlight in this quarter in that sense. And then you combine that with the product launches that we're heading toward inside of this year, then that sets up a nice platform for growth as we look at next year.

因此，當我們回顧最近推出的產品時，我們將現有平台 Simcyp 的優勢視為本季的一個主要亮點。然後將其與我們今年即將推出的產品結合起來，這將為我們明年的成長奠定良好的平台。

Great. And then maybe could you discuss how you aim to get regulators comfortable with incorporating AI into model important drug development?

偉大的。然後，您能否討論如何讓監管機構願意將人工智慧納入重要藥物開發的模型中？

Yes. We'll talk more about that as we launch this. But I think the -- just saying AI and model for drug development doesn't cover all of the possibilities. So I think a, as a regulator, I think you have to be questioning any kind of a black box where an AI is making a recommendation that you don't understand how they got there. We're well aware of that, and that's not what this does.

是的。我們將在發佈時詳細討論這個問題。但我認為——僅僅說人工智慧和藥物開發模型並不能涵蓋所有的可能性。因此，我認為，作為一名監管者，你必須質疑任何類型的黑盒子，其中人工智慧會提出你不明白他們是如何得出這個建議的。我們很清楚這一點，但這並不是它的作用。

What this type of technology does is it allows AI to process a lot of the scientific information we need to create models, and it allows us to build models much more quickly with our experts, but still in an explainable way. So in MIDD, the name of the game is really explainability. We have to explain what's in the model, why do the -- where do we get it? What are the equations, where is the data that backs us up. And that's not going to change.

這種技術的作用是，它允許人工智慧處理我們創建模型所需的大量科學信息，並允許我們與專家一起更快地建立模型，但仍然以可解釋的方式。因此在 MIDD 中，遊戲的名稱實際上就是可解釋性。我們必須解釋模型中有什麼，為什麼——我們從哪裡得到它？方程式是什麼，支持我們的數據在哪裡。這一點不會改變。

And so I think that regulators could feel comfortable about that. But the process of how you get there and the process of how you use some of the really top experts that we have in Certara can get a lot better. Basically, we can bring down the cost of creating these models, we can bring down the time of creating them and we can speed up the overall cycle that's -- that they're used on in the drug development process.

因此我認為監管機構可以對此感到放心。但是，實現這一目標的過程以及如何利用我們在 Certara 的一些真正頂尖專家的過程可以變得更好。基本上，我們可以降低創建這些模型的成本，可以縮短創建它們的時間，可以加快它們在藥物開發過程中使用的整個週期。

Brendan Smith, TD Cowen.

布倫丹·史密斯（Brendan Smith），TD Cowen。

I wanted to ask just another one actually about some of the new customer inbounds in the wake of FDA's pushing animal testing. I think you called out a 50% of new licenses in the quarter were kind of in that biologics -- biosim for non-animal testing arena. So I guess, can you just maybe remind us how we should think about kind of the cadence over the next couple of quarters, really how and when some of the new bookings are? Or even, I guess, new preliminary inquiries could translate into any upside?

我實際上想再問一個人有關 FDA 推行動物試驗後一些新客戶的情況。我認為您提到本季 50% 的新許可證都屬於生物製劑——非動物測試領域的生物相似藥。所以我想，您能否提醒我們一下，我們應該如何考慮接下來幾季的節奏，一些新的預訂究竟是如何以及何時進行的？或者，我猜，新的初步調查可能會帶來任何好處？

I mean I totally understand there's always some variability in customer timing and all that, but just trying to understand some of your internal assumptions around a brand-new customer comes to you specifically because of FDA, what you expect kind of average time from first outreach to revenue recognition for you all looks like? And maybe what some of those considerations have been this quarter?

我的意思是，我完全理解客戶時間總是會有一些變化，但是只是想了解一下您對由於 FDA 而專門來找您的全新客戶的一些內部假設，您預計從第一次接觸到收入確認的平均時間是什麼樣的？本季可能有哪些考量？

Yes. Well, probably the first thing to highlight, Brendan, would be the QSP business and the Simcyp business, we've said previously, would be the areas that would be sort of the initial beneficiaries here. That being said, we do think it's a long-term conversion, as we discussed earlier in the call.

是的。好吧，布倫丹，可能首先要強調的是 QSP 業務和 Simcyp 業務，我們之前說過，這兩個領域將是這裡的最初受益者。話雖如此，我們確實認為這是一個長期的轉變，正如我們在電話會議中早些時候討論的那樣。

But we've seen strength in QSP and Simcyp, as we mentioned earlier, in the quarter, and as we look at the remainder of the year, there's certainly potential upside in those two areas, which is book services on QSP services and Simcyp software. So the customer conversations have been good. And I think that we're increasing the dialogue while at the same time, those businesses are outperforming our expectations on the year.

但正如我們之前提到的，我們在本季度看到了 QSP 和 Simcyp 的強勁表​​現，展望今年剩餘時間，這兩個領域肯定具有潛在的上升空間，即 QSP 服務和 Simcyp 軟體上的圖書服務。因此與客戶的對話一直都很順利。我認為我們正在加強對話，同時這些業務今年的表現也超出了我們的預期。

Steven Dechert, KeyBanc.

史蒂文·德切特（Steven Dechert），KeyBanc。

I just want to dig into the Tier 1 son of software renewals. Anything specific to point to there?

我只是想深入研究軟體更新的一級子系統。有什麼具體的東西可以指出嗎？

No. The way to think about it is that bookings are lumpy on a quarterly basis. We've certainly seen that historically. Revenue was strong, organic revenue at 9%. (inaudible) organic bookings were at 11%.

不。可以這樣想：預訂量按季度來看是不均勻的。我們在歷史上確實見過這種情況。收入強勁，有機收入達 9%。 （聽不清楚）有機預訂量達 11%。

So that's indicative of what we've been booking, and we have good visibility into the second half renewals during the year. So -- that gives us a lot of confidence as we approach the remainder of 2025.

這表明了我們一直在預訂的情況，並且我們對今年下半年的續約情況有很好的了解。因此，當我們接近 2025 年剩餘時間時，這給了我們很大的信心。

Okay. And then given the strength you're seeing in QSP, what's the profitability of that product relative to your other offerings?

好的。那麼，鑑於您在 QSP 中看到的優勢，該產品相對於您的其他產品的盈利能力如何？

Well, keep in mind, to QSP, as it stands right now is services. So we've -- and it's a combination of our existing practice along with Applied BioMath, which was an acquisition from 2023, which gives us a market-leading position there. Profitability profile is what you'd expect of a services business. And as Bill mentioned earlier on the call, then too, we're actively working to roll out some software associated with QSP in the form of Certara IQ later this year.

好吧，請記住，對於 QSP 來說，它現在就是服務。因此，我們將現有的業務與 Applied BioMath 結合起來，後者是我​​們在 2023 年收購的，這使我們在該市場處於領先地位。獲利狀況正是您對服務業務的期望。正如比爾早些時候在電話中提到的那樣，我們正在積極努力，並計劃在今年稍後以 Certara IQ 的形式推出一些與 QSP 相關的軟體。

(Operator Instructions) Max Smock, William Blair.

（操作員指示）Max Smock，William Blair。

Maybe just following up on an earlier question around QSP, and you flagged the 50% of new engagements tied to MAD just kind of a proxy for the uptick in demand you think you've seen since the FDA guidance is released. But just wonder if you can give some more context around what the breakdown of therapeutic modality looked like for QSP pre-FDA guidance?

也許只是跟進之前關於 QSP 的一個問題，您標記了與 MAD 相關的 50% 的新約定，這只是您認為自 FDA 指南發布以來看到的需求上升的一種代表。但我懷疑您是否可以提供一些背景信息，說明 QSP FDA 指南發布之前的治療方式細分情況？

And then any context you have around what portion of those engagements that you flagged in the quarter wouldn't have been on, in your opinion, without that FDA guidance.

那麼，您認為，如果沒有 FDA 的指導，那麼您在本季度標記的這些活動的部分內容就不會出現。

Yes. Thanks, Max, for the question. So QSP has been working heavily on mAbs for some time. The FDA made an announcement, which I think, is a result of the fact that there is a -- I'm guessing as a result of the fact that there is so much modeling going on in mAbs and you can get some pretty good answers out of that. I would -- I'm not going to give you the specific numbers, but there's been somewhat of an uptick since the FDA made their announcement.

是的。謝謝馬克斯提出的問題。因此 QSP 一直在大力研究 mAb。FDA 發布了一項聲明，我認為這是因為——我猜是因為在 mAb 方面正在進行大量建模，​​你可以從中得到一些非常好的答案。我不會給你具體的數字，但自從 FDA 宣布這一消息以來，情況有所上升。

I think, however, there wasn't like an FDA announcement in the next day, all of a sudden, everybody switched to using QSP, there's been a process since the announcement kind of started with one of the webinars that we very well-attended webinars that we gave right after the FDA announcement, where companies have been exploring what's the possibility and what's the meaning of what the FDA is talking about.

然而，我認為，FDA 不會在第二天就發佈公告，然後突然間，每個人都轉而使用 QSP，從公告發布以來，有一個過程，從我們在 FDA 公告發布後立即舉辦的一次網絡研討會開始，參加人數很多，公司一直在探索這種可能性以及 FDA 所談論的內容的含義。

And during that process, a lot of them learned about the benefits of QSP and we picked up from there. So it's been good for business so far. Is it -- is it like at the maximum rate. Now it's going to take some time for the market to really build up and gain confidence about exactly how the FDA want this to play forward, but it's definitely driven a lot of interest in that type of modeling and has driven revenues to the company.

在這個過程中，許多人了解到了 QSP 的好處，我們也從中學到了一些東西。因此，到目前為止，這對業務來說是件好事。它是——它是以最大速率嗎？現在，市場需要一些時間來真正建立並對 FDA 的具體發展方向產生信心，但它確實引起了人們對此類建模的極大興趣，並為公司帶來了收入。

So I'll just leave it there.

所以我就把它留在那裡了。

That's helpful. Understood. Maybe turning to margins. The midpoint of the guide implies about 30% in the second half, kind of well below you did 32% in the first half. And I know you talked about hiring being a driver there. But -- can you just walk through any of the other kind of factors that are leading to that step down in 2H in the second half of the year here, and then the cadence between the third quarter and fourth quarter.

這很有幫助。明白了。也許轉向利潤。該指南的中點意味著下半年約為 30%，遠低於上半年的 32%。我知道您談到了在那裡招聘司機。但是—您能否簡單介紹一下導致今年下半年下滑的其他因素，以及第三季和第四季之間的節奏。

And then, John, I think more importantly, is going to be a good jumping off point for thinking about margins next year? Or are you going to moderate investments to make sure that you're protecting margins in 2026?

然後，約翰，我認為更重要的是，這將是考慮明年利潤率的一個好起點？或者您會適度投資以確保在 2026 年保護利潤率？

Yes. Max. So -- so first half was impacted by some slower hiring in Q1. So the best way to model for the remainder of the year, Q2 is a good jumping off point. So our 13.5% margin in Q2 is a good way to think that as we ramp -- as we continue to ramp the investment coming out of Q2 and into Q3 and Q4, then that's the Q2 margin is a good proxy.

是的。最大限度。因此，上半年受到第一季招募放緩的影響。因此，對於今年剩餘時間的預測來說，最好的方式是第二季是一個很好的起點。因此，我們第二季 13.5% 的利潤率是一個很好的想法，隨著我們繼續增加從第二季到第三季和第四季的投資，那麼第二季的利潤率就是一個很好的代表。

And Q1 is less so, so I put it more in the quarter than the first half. That's the way to think about how to model the full year from a margin perspective because of those investments coming in. And then as far as the jumping off point for the margin next year, sort of aligned with what I was just saying, the investments that we're making are -- that hiring is going to take place during -- some of it was in 2Q. There will be more of it in Q3 and into Q4. So I would say that Q4 would be a decent proxy for where we go ahead into the next year.

而第一季的情況則不那麼嚴重，因此我將其更多地放在季度而不是上半年。由於這些投資的進入，這就是從利潤率角度思考如何模擬全年的方式。至於明年利潤的起點，與我剛才所說的一致，我們正在進行的投資是 - 招聘將在第二季度進行 - 其中一些是在第二季度。第三季和第四季還會有更多這樣的情況。因此我想說第四季可以很好地代表我們明年的發展方向。

Gabriel Weiner, Jefferies.

加布里埃爾·韋納 (Gabriel Weiner)，傑富瑞 (Jefferies)。

Dave Windley here. Is it me? I think it's probably me. if you can hear me?

這裡是戴夫·溫德利。是我嗎？我想那可能就是我了。你聽得到我說話嗎？

Yes.

是的。

So I wanted to ask around kind of adoption curve. So Certara has been in this modeling business for a couple of decades, probably seeing several adoption curves. And so my question is, what are the telltale signs of clients that are on the cusp of, say, climbing the steeper looking adoption curve? Is it hiring more people in their quantitative sciences divisions? Is it running pilot programs what might that look like?

所以我想詢問一下採用曲線的情況。因此，Certara 已在建模業務領域經營了數十年，可能已經見證過幾條採用曲線。所以我的問題是，客戶即將迎來更陡峭的採用曲線，有哪些明顯的跡象？他們的定量科學部門是否會招募更多員工？它是否正在運行試點項目，看起來是什麼樣的？

And I'm asking as something to look for as it relates to the NAMs and how we might try to observe pharma companies stepping into adoption of NAMs?

我問的是與 NAM 相關的一些問題，以及我們如何嘗試觀察製藥公司如何採用 NAM？

Yes. Thank you, David. It's a complicated question because of the many different players in this market and frankly, there lots of just the technical aspects of where biosimulation is used. But if I want to generalize, we often start with services. So a company I don't -- it's not exactly a pilot program, but the first one through often is a project that gets conducted by Certara, and then as companies get excited and feel confident in what we're doing, they become -- they become software customers as we go forward.

是的。謝謝你，大衛。這是一個複雜的問題，因為這個市場有許多不同的參與者，而且坦白說，生物模擬的使用有很多技術方面的問題。但如果我想概括的話，我們通常從服務開始。因此，我不認為公司——這實際上是一個試點項目，但第一個項目通常是由 Certara 進行的項目，然後隨著公司對我們所做的事情感到興奮和有信心，他們就會成為——隨著我們的前進，他們就會成為軟體客戶。

So if we look at that on NAMs, I don't -- I guess, say NAMs is kind of an interesting thing because it's only this whole announcement from the FDA has only been around a few months, which is really no time in the way pharma operates, yet there has been a tremendous amount of interest. We've been hired to do everything from additional QSP projects to strategy projects around what does this mean for my drug and how do I change the way I think about bringing it forward -- and that's happened very, very quickly.

因此，如果我們從 NAM 的角度來看，我不認為 — — 我想，NAM 是一件有趣的事情，因為 FDA 的整個公告才發布幾個月，這對於製藥業的運營方式來說真的不算短，但卻引起了人們極大的興趣。我們被雇用來做各種事情，從額外的 QSP 項目到戰略項目，圍繞著這對我的藥物意味著什麼，以及我如何改變我對推進這一藥物的思考方式——這一切都發生得非常非常快。

So we're sort of trying to project off just a few months as to how this is going to play out over a multiyear process going forward here. But I think -- in this case, what we see is, number one, companies are very interested in NAMs, right? A number of them kind of combine this with a test of additional modeling or biosimulation in their projects.

因此，我們試圖預測未來幾個月內這一進程將如何發展。但我認為——在這種情況下，我們看到的是，首先，公司對 NAM 非常感興趣，對嗎？他們中的許多人在他們的專案中將此與額外的建模或生物模擬測試結合起來。

So it's all good in terms of it's driving business to us, but it's a little bit convoluted about maybe the -- don't oftentimes try to do multiple things when they start working with this.

因此，從為我們帶來業務的角度來看，這一切都很好，但也許有點複雜——當他們開始使用這個時，通常不要嘗試做多件事。

Yes. Maybe as a follow-up to that is are and trying to understand how the client might use or might try to arrive at the answers that they're trying to achieve without using animal models and insomuch as Simcyp is an area that you're pointing to as being invoked by this QSP lie newer, but like let's focus on Simcyp is the client using Simcyp in a different way to produce different answers than the clients have typically used Simcyp to do?

是的。也許作為後續行動，我們正在嘗試了解客戶如何使用或嘗試在不使用動物模型的情況下獲得他們想要實現的答案，並且由於 Simcyp 是您所指出的由該 QSP 調用的一個領域，因此比較新，但讓我們關注 Simcyp，客戶端是否以不同的方式使用 Simcyp 來產生與客戶端通常使用 Simcyp 不同的答案？

Or are they kind of running similar maybe more intensive, but similar types of analyses modeling, as they've done with Simcyp in the past, but just our -- say trusting those answers more and moving on without, say, verifying in animals.

或者他們是否在運行類似的、可能更密集但類似類型的分析模型，就像他們過去對 Simcyp 所做的那樣，但只是我們的——說更加相信這些答案並繼續前進，而無需在動物身上進行驗證。

So the way I can explain it is this for some time, many of our customers have been doing modeling in monoclonal antibodies in parallel to their animal testing. And there -- the modeling has produced results that if the FDA allows it and when (inaudible) fostering it can be used to reduce, maybe not totally eliminate the use of animals. So they've done that. Why are they doing that modeling in parallel? Well, really, it's being done in parallel because it produces useful information that is kind of difficult to get from animals.

我可以這樣解釋：一段時間以來，我們的許多客戶一直在進行單株抗體建模，同時進行動物測試。而且 — — 該模型得出的結果是，如果 FDA 允許並且（聽不清楚）培育它，它可以用來減少（也許不能完全消除）動物的使用。所以他們就這麼做了。他們為什麼要同時進行建模？嗯，實際上，它是同時進行的，因為它產生了一些很難從動物身上獲得的有用資訊。

So for example, if you're trying to do first in human dosing, it's one thing to try that on a primate, but you can get a much better answer if you use modeling. And if you get a better answer, you're more likely to make better use of your Phase 1 trials where you're trying to figure out the effective dosing range.

舉例來說，如果您嘗試首先對人類進行給藥，那麼在靈長類動物身上嘗試是一回事，但如果您使用建模，您可以得到更好的答案。如果您得到更好的答案，您就更有可能更好地利用第一階段試驗，嘗試找出有效的劑量範圍。

So that's why they're doing that. that data, however, now everybody is looking at it and saying, wow, we can use some of this data and we can -- if the FDA allows us, we can reduce the number of animals as we go forward. So that's good.

這就是他們這樣做的原因。然而，現在每個人都在看這些數據，並說，哇，我們可以使用其中的一些數據，而且我們可以——如果 FDA 允許的話，我們可以減少動物的數量。這很好。

Those are our customers that are already working on it. They're taking some of the modeling, they were doing the other reasons and they're sort of like getting some additional benefit. And then other companies that were maybe on the fence about doing that are saying, well, we ought to start taking a look at QSP as well. So that's why we say that this has been good for business so far.

這些都是我們已在致力於此的客戶。他們正在進行一些建模，他們正在做其他的事情，他們有點像是在獲得一些額外的好處。然後其他對此猶豫不決的公司則表示，好吧，我們也應該開始考慮 QSP。這就是為什麼我們說到目前為止這對業務有利。

There's still some quite -- I mean, I don't think anybody has actually gotten to the point of taking a drug application to the FDA with reduced use of animals so far is -- like I said, it's only in a few months, hopefully, as that happens, then we'll see some kind of a falling effect as that drives even more interest.

仍然有一些相當的——我的意思是，我認為到目前為止，還沒有人真正達到向 FDA 提交減少使用動物的藥物申請的程度——就像我說的，希望只需要幾個月的時間，當這種情況發生時，我們就會看到某種下降效應，因為這會引起更多的興趣。

Thank you. I am showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

謝謝。我目前沒有其他問題。感謝大家參加今天的會議。該計劃確實就此結束。您現在可以斷開連線。