Certara Inc (CERT) 2025 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Certara first quarter 2025 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, David Deuchler, Investor Relations. Please go ahead.

您好，感謝您的支持。歡迎參加 Certara 2025 年第一季財報電話會議。（操作員指示）請注意，今天的會議正在錄音。現在我想將會議交給今天的發言人，投資者關係部門的 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, Certara released financial results for the quarter ended March 31, 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 的電話會議中，我們採訪了執行長 William Feehery；以及財務長 John Gallagher。今天早些時候，Certara 發布了截至 2025 年 3 月 31 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.

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。

Please refer to slide 2 in the accompanying materials for additional information, which you can find on the company's Investor Relations website. In the remarks or responses to questions, management may mention some non-GAAP financial measures. Reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures are available in the recent earnings press release available on the company's website. Please refer to the reconciliation tables in the accompanying materials for additional information.

請參閱隨附資料中的幻燈片 2 以獲取更多信息，您可以在公司的投資者關係網站上找到這些資訊。在評論或回答問題時，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 財務指標的對帳表可在公司網站上的最新收益新聞稿中找到。請參閱隨附資料中的對帳表以獲取更多資訊。

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 5, 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 links or otherwise.

本次電話會議包含時間敏感訊息，僅截至今天（2025 年 5 月 5 日）的現場直播時準確。除法律要求外，Certara 不承擔更新或修改任何財務預測或前瞻性聲明的任何義務，無論是由於新資訊、未來連結或其他原因。

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. Good afternoon, everyone. Thank you for joining Certara's first 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 第一季財報電話會議。約翰和我將先發表準備好的發言，然後回答大家的提問。

We are pleased with our start to the year, delivering financial results consistent with our expectations, driven by strong commercial execution across both software and services. We finished the first quarter with revenue of $106.0 million, representing 10% reported growth versus the first quarter of 2024. Certara's first quarter bookings of $118.2 million represented 12% reported growth versus the prior year period, driven by software bookings growth of 23% and services bookings growth of 7%.

我們對今年的開局感到滿意，在軟體和服務領域強勁的商業執行的推動下，我們取得了符合預期的財務業績。我們第一季的營收為 1.06 億美元，與 2024 年第一季相比成長了 10%。Certara 第一季的預訂額為 1.182 億美元，比去年同期增長 12%，其中軟體預訂額增長 23%，服務預訂額增長 7%。

Additionally, we continue to see good performance from Chemaxon, which contributed $5.9 million of revenue and $4.9 million of bookings in the quarter. The current market has both continued headwinds that we've been managing over the past couple of years, as well as some new and exciting tailwinds for Certara. Continued headwinds include the downstream effects of IRA price controls and erratic capital-raising environment for biotech and the potential for new trade and health care policies from the current administration.

此外，我們繼續看到 Chemaxon 的良好表現，該公司在本季度貢獻了 590 萬美元的收入和 490 萬美元的預訂量。目前市場既有我們過去幾年一直在應對的持續逆風，也有 Certara 面臨的一些新的令人興奮的順風。持續的不利因素包括 IRA 價格控制的下游影響、生物技術不穩定的融資環境以及現任政府可能出台的新貿易和醫療政策。

Tailwinds include the recent FDA announcement about phasing out animal testing, a general willingness to expand the use of modeling in pharmaceutical development and increasing spending on artificial intelligence solutions amongst our customers. In the long run, we expect most of the headwinds to resolve while the tailwinds are likely to remain in Certara's favor.

有利因素包括 FDA 最近宣布逐步淘汰動物試驗、普遍願意擴大模型在藥物開發中的應用以及增加客戶對人工智慧解決方案的支出。從長遠來看，我們預計大部分不利因素將會得到解決，而順風因素可能仍對 Certara 有利。

With that in mind, we will continue to execute our strategic investment plan focusing on the integration of AI into our software solutions, building a more integrated software platform, increasing our investment in biosimulation model development and expanding our solutions into the earlier stages of drug development. Certara's value proposition is multifaceted. We accelerate decision-making to drive more cost-effective development by making better use of scientific modeling and data analysis.

考慮到這一點，我們將繼續執行我們的策略性投資計劃，重點是將人工智慧整合到我們的軟體解決方案中，建立更整合的軟體平台，增加對生物模擬模型開發的投資，並將我們的解決方案擴展到藥物開發的早期階段。Certara 的價值主張是多方面的。我們透過更好地利用科學建模和數據分析來加快決策，以推動更具成本效益的發展。

Over the past several years, we've invested to build Certara into the leading partner in biosimulation by creating new software products and features, building a robust commercial infrastructure capable of selling to the large number of customers in our industry and executing strategic M&A to expand our capabilities.

在過去的幾年中，我們透過創造新的軟體產品和功能、建立能夠向我們行業中的大量客戶銷售產品的強大商業基礎設施以及執行策略併購來擴展我們的能力，將 Certara 打造為生物模擬領域的領先合作夥伴。

The FDA's recent announcement of a plan to phase out animal testing requirements for monoclonal antibodies and other drugs increases the relevance of Certara's capabilities. This new direction follows a framework outlined by Congress and the FDA Modernization Act 2.0 that was passed in late 2022 and aims to develop a clear regulatory pathway to streamline the drug development process, including leveraging computer modeling and artificial intelligence to predict a drug's behavior.

FDA 最近宣布了一項逐步取消單株抗體和其他藥物的動物試驗要求的計劃，這增加了 Certara 能力的相關性。這一新方向遵循國會和 2022 年底通過的 FDA 現代化法案 2.0 概述的框架，旨在製定明確的監管途徑以簡化藥物開發流程，包括利用電腦建模和人工智慧來預測藥物的行為。

Certara has created a biosimulation solution called Non-Animal Navigator for preclinical monoclonal antibody development, which uses our Simcyp simulator and our QSP modeling group. The solution also leverages the extensive experiences of our services team in creating human study designs. In the weeks following the announcement, we have seen significant inbound interest from customers who would like to understand the role Certara can play in their preclinical development.

Certara 為臨床前單株抗體開發創建了一種名為 Non-Animal Navigator 的生物模擬解決方案，該解決方案使用了我們的 Simcyp 模擬器和我們的 QSP 建模組。該解決方案還利用了我們的服務團隊在創建人體研究設計方面的豐富經驗。在公告發布後的幾週內，我們看到客戶表現出濃厚的興趣，他們希望了解 Certara 在其臨床前開發中可以發揮的作用。

Just last week, we hosted an online webinar with over 400 attendees, outlining our approach to helping customers navigate alternatives to animal testing. We believe new regulatory initiatives at the FDA, including phasing out animal testing, our long-term tailwinds for the adoption of modeling and simulation tools across drug development phases.

就在上週，我們舉辦了一場線上網路研討會，有超過 400 名與會者參加，概述了我們幫助客戶探索動物測試替代方案的方法。我們相信 FDA 的新監管舉措，包括逐步取消動物試驗，是我們在藥物開發階段採用建模和模擬工具的長期推動力。

Now turning to our commercial performance in the quarter. In software, we continue to see healthy bookings performance from our Tier 1 and Tier 3 customers, with high renewal rates and a modest upsell contributing to growth. We have also begun to realize some cross-selling benefits as we integrate Chemaxon into our broader commercial organization leading to another strong quarter with $5.9 million of revenue.

現在來談談我們本季的商業表現。在軟體方面，我們繼續看到來自第一級和三級客戶的健康預訂表現，高續約率和適度的追加銷售促進了成長。隨著我們將 Chemaxon 整合到我們更廣泛的商業組織中，我們也開始實現一些交叉銷售的好處，從而帶來另一個強勁的季度，收入達到 590 萬美元。

In services, we observed stable demand across both biosimulation services and regulatory services. In biosimulation services, we continue to see some softness in the Tier 1 customer base, which was offset by solid growth across Tiers 2 and 3.

在服務方面，我們觀察到生物模擬服務和監管服務的需求都很穩定。在生物模擬服務方面，我們繼續看到一級客戶群的疲軟，但二級和三級客戶的穩健成長抵消了這一疲軟。

In regulatory services, we saw revenue and bookings growth on a year-over-year basis with strong contribution across all three customer tiers. Heading into the second quarter, we are encouraged by the underlying demand from customers and are confident in our ability to meet our commercial goals at this point in the year.

在監管服務方面，我們的收入和預訂量同比增長，對所有三個層級的客戶都做出了巨大貢獻。進入第二季度，客戶的潛在需求令我們感到鼓舞，我們有能力在今年這個時候實現我們的商業目標。

In addition to strong commercial performance, our R&D teams continue to make progress in the software development front. On April 1, we announced the 24 version of our Simcyp simulator, which was the culmination of months of hard work from our team, paired with valuable feedback and insights from over 30 consortium members.

除了強勁的商業表現外，我們的研發團隊在軟體開發方面也不斷取得進步。4 月 1 日，我們發布了 Simcyp 模擬器的第 24 版，這是我們團隊數月辛勤工作的成果，並結合了來自 30 多個聯盟成員的寶貴反饋和見解。

This year, updates were focused on numerous new features, including an expanded library for drug-drug interactions, additions to our biopharmaceutical and virtual bioequivalence modules, enhancements to support modeling of special populations and an improved user interface.

今年的更新主要集中在眾多新功能上，包括擴展的藥物交互作用庫、增加生物製藥和虛擬生物等效性模組、增強對特殊人群建模的支援以及改進的用戶介面。

To date, Simcyp has supported over 120 FDA-approved novel drug applications and over 300 label claims in addition to being granted numerous clinical trial waivers. As we expand the breadth and capability of our software platform, we look to stay active and in front of our customers. We are excited to host the second annual Certainty Conference in Philadelphia beginning tomorrow.

迄今為止，Simcyp 已支持超過 120 個 FDA 批准的新藥申請和超過 300 個標籤聲明，並且獲得了許多臨床試驗豁免。隨著我們軟體平台的廣度和功能的不斷擴展，我們希望保持活躍並走在客戶前面。我們很高興明天將在費城舉辦第二屆年度確定性會議。

Last year's conference was a success, and we are thrilled to host over 300 clients showcasing the advancements we've made in model-informed drug development. Certainty has become an opportunity time to showcase our capabilities in the preclinical area as our customers look for alternatives to animal testing, and there will be several presentations elaborating on how Certara can help drug developers implement new approach methodologies such as PBPK and QSP.

去年的會議取得了成功，我們很高興接待了 300 多位客戶，展示我們在模型知情藥物開發方面取得的進展。當我們的客戶尋找動物試驗的替代方案時，確定性已成為展示我們在臨床前領域的能力的機會，並且將有幾場演講詳細闡述 Certara 如何幫助藥物開發商實施 PBPK 和 QSP 等新方法。

During the quarter, we also had the pleasure of welcoming new leadership to our services group. We're pleased to welcome Dr. Adrian McKemey as President of our Drug Development Solutions business. Adrian joined Certara with over 25 years of industry experience, having led business transformation, portfolio management and R&D initiatives for a wide variety of clients in the biopharma industry.

本季度，我們也很高興地歡迎新領導者加入我們的服務集團。我們很高興歡迎 Adrian McKemey 博士擔任我們的藥物開發解決方案業務總裁。Adrian 加入 Certara 時已擁有超過 25 年的行業經驗，曾領導生物製藥行業眾多客戶的業務轉型、投資組合管理和研發計劃。

As part of the planned leadership transition, Patrick Smith has moved into a new role as Senior Vice President of Translational Sciences. Patrick will continue to be a key member of our services group focusing on Certara's scientific growth and innovation.

作為計劃中的領導層過渡的一部分，帕特里克史密斯 (Patrick Smith) 已出任轉化科學高級副總裁一職。帕特里克將繼續擔任我們服務團隊的重要成員，專注於 Certara 的科學發展和創新。

Before wrapping up, I wanted to provide an update on some recent announcements. On April 14, we announced a $100 million share repurchase authorization and provided an update on the strategic review of our regulatory business. The Board's decision to authorize a share repurchase allows us to have more flexibility with the management of our capital to drive value for shareholders. This authorization for the Board reflects their support and confidence in our investment in biosimulation, including AI and in the strategic decisions we have made to drive long-term growth for the company.

在結束之前，我想提供一些最新公告的更新資訊。4月14日，我們宣布了1億美元的股票回購授權，並提供了監管業務策略審查的最新進展。董事會批准股票回購的決定使我們能夠更靈活地管理資本，從而為股東創造價值。董事會的此項授權反映了他們對我們在生物模擬（包括人工智慧）方面的投資以及我們為推動公司長期成長而做出的策略決策的支持和信心。

However, our primary use of capital remains the same as it has been since we became public, and we will continue to be active in looking at M&A opportunities and making organic strategic investments to drive long-term sustainable growth. Also, as we announced, we have been proceeding with our review of the regulatory business and have received interest from external parties that we do not have more to announce at this time.

然而，我們對資本的主要用途與上市以來一直沒有改變，我們將繼續積極尋找併購機會並進行有機策略投資，以推動長期可持續成長。此外，正如我們所宣布的，我們一直在對監管業務進行審查，並收到了外部各方的關注，目前我們沒有更多消息可以宣布。

To close, we are pleased with our first quarter results, and we are excited by the evolving opportunities at the company. Our team is executing against our commercial plan, driving solid operational performance in light of more muted end markets. Our R&D initiatives are progressing nicely, and we are on track to launch several new products later this year. The secular tailwinds for biosimulation continue to drive adoption, and we are excited to play a role in the evolution of drug development towards new methods and approaches.

最後，我們對第一季的業績感到滿意，並對公司不斷發展的機會感到興奮。我們的團隊正在按照我們的商業計劃執行，在終端市場較低迷的情況下推動穩健的營運績效。我們的研發工作進展順利，我們預計在今年稍後推出幾款新產品。生物模擬的長期順風繼續推動其應用，我們很高興能夠在藥物開發到新方法和新途徑的演變中發揮作用。

With that, I'd like now to hand things over to John Gallagher to discuss our financial results in more detail.

現在，我想將時間交給約翰·加拉格爾 (John Gallagher) 來更詳細地討論我們的財務表現。

Thank you, William. Hello, everyone. Total revenue for the three months ended March 31, 2025, was $106 million, representing year-over-year growth of 10% on a reported basis and on a constant currency basis. Total bookings for the first quarter were $118.2 million, which increased 12% from the prior year period on a reported basis. Trailing 12-month bookings were $457.7 million, increasing 16% on a reported basis. Excluding Chemaxon, total company organic bookings growth was 7% compared with the first quarter of last year.

謝謝你，威廉。大家好。截至 2025 年 3 月 31 日的三個月的總收入為 1.06 億美元，按報告基礎和固定匯率計算同比增長 10%。第一季的總預訂額為 1.182 億美元，據報告比去年同期增長 12%。過去 12 個月的預訂金額為 4.577 億美元，較去年同期成長 16%。不包括 Chemaxon，該公司整體有機預訂量與去年第一季相比成長了 7%。

Software revenue was $46.4 million in the first quarter, which increased 18% over the prior year period on a reported basis and 19% on a constant currency basis. Organic growth in the quarter was driven by biosimulation software and Pinnacle 21.

第一季軟體營收為 4,640 萬美元，以報告基礎計算比去年同期成長 18%，以固定匯率計算比去年同期成長 19%。本季的有機成長得益於生物模擬軟體和 Pinnacle 21。

Additionally, Chemaxon contributed $5.9 million to our reported revenue, which came in ahead of our expectations. Ratable and subscription revenue accounted for 57% of first quarter software revenues or 62% when excluding Chemaxon, up from 61% in the prior year period. Software bookings were $40.8 million in the first quarter, which increased 23% from the prior year period.

此外，Chemaxon 為我們報告的收入貢獻了 590 萬美元，超出了我們的預期。按比例分配和訂閱收入佔第一季軟體收入的 57%，不包括 Chemaxon 時則為 62%，高於去年同期的 61%。第一季軟體訂單金額為 4,080 萬美元，比去年同期成長 23%。

First quarter bookings include $4.9 million of Chemaxon bookings. Trailing 12-month software bookings were $177.3 million, up 27% year-over-year. The software net retention ratio was 102% in the quarter. With organic software revenue growth up 4% in Q1, consistent with our plan, this NRR is below the historic average based on expected timing of software revenue achievement during 2025.

第一季的訂單包括 490 萬美元的 Chemaxon 訂單。過去 12 個月的軟體訂單金額為 1.773 億美元，較去年同期成長 27%。本季軟體淨留存率為102%。由於第一季有機軟體收入成長率為 4%，與我們的計劃一致，這一 NRR 低於基於 2025 年軟體收入實現預期時間的歷史平均水平。

Looking at our software bookings performance by tier, we saw very strong performance in both Tier 1 and Tier 3 customers in the first quarter, driven by continued adoption of our software. Now turning to services revenue, which was $59.6 million in the first quarter, up 4% versus the prior year period on a reported basis and on a constant currency basis. We saw strong performance from our regulatory services business in the quarter, delivering a second consecutive quarter of year-on-year growth.

從各層級的軟體預訂表現來看，第一季度，由於我們軟體的持續採用，一級和三級客戶的表現都非常強勁。現在談談服務收入，第一季服務收入為 5,960 萬美元，按報告基礎和固定匯率計算比去年同期增長 4%。本季我們的監管服務業務表現強勁，連續第二季實現年比成​​長。

Technology-driven services bookings in the first quarter were $77.4 million, which increased 7% from the prior year period. TTM services bookings were $280.4 million, up 10% as compared to the prior year. In the quarter, we saw stable demand for our biosimulation services with softness in Tier 1, offset by strong bookings growth in Tiers 2 and 3. Regulatory writing bookings grew double digits versus the first quarter of 2024.

第一季技術驅動服務訂單金額為 7,740 萬美元，比去年同期成長 7%。TTM 服務預訂金額為 2.804 億美元，比上年增長 10%。本季度，我們的生物模擬服務需求穩定，但一線市場表現疲軟，而二線和三線市場的預訂量強勁增長則抵消了這一影響。與 2024 年第一季相比，監管寫作訂單量增加了兩位數。

Total cost of revenue for the first quarter of 2025 was $41.5 million, an increase from $39.3 million in the first quarter of 2024, primarily due to higher software amortization expense. Total operating expenses for the first quarter of 2025 were $56.9 million, a slight decrease from $58.7 million in the first quarter of 2024 primarily due to a $3.1 million decrease in the change in fair value of the contingent consideration, which was offset by higher sales and marketing expense and intangible asset amortization.

2025 年第一季的總收入成本為 4,150 萬美元，高於 2024 年第一季的 3,930 萬美元，主要原因是軟體攤提費用增加。2025 年第一季的總營運費用為 5,690 萬美元，較 2024 年第一季的 5,870 萬美元略有下降，主要原因是或有對價的公允價值變動減少了 310 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 first quarter of 2025 was $34.8 million, an increase from $29.1 million in the first quarter of 2024. Adjusted EBITDA margin in the quarter was 33%, which came in ahead of our expectations. As I discussed last quarter, we plan to continue investing in R&D in 2025 to drive new product development and further integrate our software.

2025 年第一季調整後 EBITDA 為 3,480 萬美元，高於 2024 年第一季的 2,910 萬美元。本季調整後的 EBITDA 利潤率為 33%，超出我們的預期。正如我上個季度所討論的，我們計劃在 2025 年繼續投資研發，以推動新產品開發並進一步整合我們的軟體。

In the first quarter, we saw some benefit to EBITDA from slower-than-expected hiring, which contributed about 200 basis points to our EBITDA margin. We expect hiring to pick up through the middle of the year, which will align margins more closely with our guidance expectations over the next several quarters.

在第一季度，我們看到招募速度低於預期，這對 EBITDA 產生了一些好處，為我們的 EBITDA 利潤率貢獻了約 200 個基點。我們預計到今年年中招聘將會回升，這將使利潤率在未來幾季更接近我們的指導預期。

Wrapping up the income statement. Net income for the first quarter of 2025 was $4.7 million compared to a net loss of $4.7 million in the first quarter of 2024. Reported adjusted net income for the first quarter of 2025 was $22.4 million compared to $16.5 million for the first quarter of 2024.

總結損益表。2025 年第一季淨收入為 470 萬美元，而 2024 年第一季淨虧損為 470 萬美元。2025 年第一季的調整後淨收入為 2,240 萬美元，而 2024 年第一季為 1,650 萬美元。

Diluted earnings per share for the first quarter of 2025 was $0.03 compared to a loss of $0.03 per share in the first quarter of 2024. Adjusted diluted earnings per share for the first quarter of 2025 was $0.14 compared to $0.10 for the first quarter of last year.

2025 年第一季每股攤薄收益為 0.03 美元，而 2024 年第一季每股虧損為 0.03 美元。2025 年第一季調整後每股攤薄收益為 0.14 美元，去年第一季為 0.10 美元。

Moving to the balance sheet. We finished the quarter with $179.1 million in cash and cash equivalents. As of March 31, 2025, we had $294.8 million of outstanding borrowings on our term loan and full availability under our revolving credit facility. As William mentioned earlier, the Board authorized a $100 million repurchase program in mid-April.

轉到資產負債表。本季末我們的現金和現金等價物為 1.791 億美元。截至 2025 年 3 月 31 日，我們的定期貸款未償還借款為 2.948 億美元，且我們的循環信貸額度已全部可用。正如威廉之前提到的，董事會在四月中旬批准了一項 1 億美元的回購計畫。

Following the announcement, we have repurchased approximately $25 million of that authorization to date. 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 with 2024.

公告發布後，我們迄今已回購了約 2,500 萬美元的授權。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 the revenue guidance and a lower EBITDA margin at the higher end of our revenue guidance. This will be driven by discretionary investments in research and development which will be managed based on our commercial performance as we progress through the year.

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。這將由對研發的自由裁量投資所推動，這些投資將根據我們全年的商業表現進行管理。

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，完全稀釋後的每股盈餘在 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 many exciting developments at Certara in the first quarter and remain focused on executing our growth and profitability goals in 2025. We are working hard to capitalize on our commercial opportunities, including the recently announced phaseout of animal testing for monoclonal antibodies and we have begun to repurchase shares under the new share purchase authorization. I am proud of the work of our team, and I look forward to providing additional color as the year progresses.

謝謝你，約翰。總結我們今天的訊息，我們對 Certara 在第一季取得的許多令人興奮的發展感到高興，並將繼續專注於實現 2025 年的成長和獲利目標。我們正在努力利用我們的商業機會，包括最近宣布逐步停止單株抗體的動物試驗，並且我們已經開始根據新的股票購買授權回購股票。我為我們團隊的工作感到自豪，並期待在未來的歲月中提供更多色彩。

Operator, can you please open the line for questions.

接線員，請開通熱線來回答問題。

(Operator Instructions) Michael Cherny, Leerink Partners.

（操作員指示）Michael Cherny，Leerink Partners。

This is Dan Clark on for Mike. First one from us. Just on the inbound interest you've received for your Non-Animal Navigator thus far, are there any teams for companies or tiers of customers that are particularly interested? And then as a second question, what do you kind of think the right NRR is for Certara in this business environment?

我是丹‧克拉克 (Dan Clark)，代替麥克 (Mike)。我們的第一個。就您迄今為止收到的有關非動物導航器的關注而言，是否有公司團隊或客戶層級特別感興趣？然後第二個問題，您認為在這種商業環境下 Certara 的正確 NRR 是多少？

Yes, thanks. I'll take the first one. We've had a tremendous amount of interest of customers coming to our webinar or calling about it. I think a lot of the market is trying to understand what the FDA wants and what the possibilities are and how fast this is going to happen.

是的，謝謝。我要第一個。大量客戶對我們的網路研討會或致電諮詢相關事宜表現出濃厚興趣。我認為很多市場都在試圖了解 FDA 想要什麼、有哪些可能性以及這將以多快的速度發生。

I think in general, companies have been interested and excited about potential change in the way drugs are developed and using fewer animals and trying to figure out how far is the FDA long in their thinking and when would they make a switch in drug development.

我認為總體而言，公司對藥物開發方式的潛在變化以及使用更少的動物感興趣並感到興奮，並試圖弄清楚 FDA 的想法有多長，以及何時會在藥物開發方面做出轉變。

So those are the kind of questions we're getting right now. And also, I'd say also just sort of how like -- how far along is the technology and what can be repaid with animals which animal usage can be replaced today? And then for the second question, I'll turn it over to John.

這些就是我們現在遇到的問題。而且，我還想說的是──這項技術發展到什麼程度了，可以用動物來償還什麼，哪些動物的使用可以取代今天的動物？對於第二個問題，我將把它交給約翰。

Yes. Thanks, Will. So on the NRR, this quarter at 102% is lower than what you've typically seen for us and that's driven by a couple of things. One is the organic software growth at 4% is lower than our implied guidance range at 6% to 8%, but it was on our expectations.

是的。謝謝，威爾。因此，就 NRR 而言，本季的 102% 低於我們通常看到的水平，這是由幾個因素造成的。一是有機軟體成長率為 4%，低於我們 6% 至 8% 的隱含指導範圍，但符合我們的預期。

So there was some expected timing related to the achievement of organic software revenues that we would expect to play out an increase over the remaining course of 2025. In addition to that, the portion of ratable software is increasing. In fact, in Q4, excluding Chemaxon, we had 70% ratable. That tends to be our high point in Q4. Here in Q1, we had 62% ratable, which was growth year-on-year.

因此，我們預計實現有機軟體收入的時間會有一些變化，我們預計在 2025 年剩餘時間內會出現成長。除此之外，可評級軟體的比例正在增加。事實上，在第四季度，不包括 Chemaxon，我們有 70% 的應稅收入。這往往是我們第四季的最高點。在第一季度，我們的應稅收入達到了 62%，比去年同期成長。

And so the more ratable that we achieve, the more that the software growth is going to roll out during the quarters of 2025. So I think in relation to what you should expect, I think it's important to look at a metric like NRR over a multi-quarter basis. So last year, we had an average of about 110. This year, what we're saying is the 102 came in on plan, and we'd expect it to increase software revenue increases.

因此，我們實現的評級越高，2025 年各季度的軟體成長就會越強勁。因此，我認為，就您應該預期的情況而言，查看多個季度的 NRR 等指標非常重要。去年，我們的平均人數約為 110 人。今年，我們的計劃是 102 個軟體都按計劃完成了，我們預計這將增加軟體收入。

Joe Vruwink, Baird.

喬·弗魯溫克，貝爾德。

Similar, I wanted to follow up on just those reaching out to you. What is the scope -- Will, you just talked about kind of the questions being asked, but what is the scope of commercial engagement look like? -- our customers wanting to give more scientists under a license agreement. Is there talk about equipping users with stuff they don't use right now.

類似地，我只想跟進那些與您聯繫的人。範圍是什麼——威爾，你剛才談到了所問的問題，但是商業參與的範圍是什麼樣的？ ——我們的客戶希望根據許可協議為更多的科學家提供支援。有沒有談論為用戶配備他們現在不使用的東西。

I think one of the things that's maybe coming up a bit more often is that QSP modeling could really inflect higher? I guess, what's kind of the initial feel on commercially, how your business might evolve?

我認為可能更常出現的事情之一是 QSP 建模真的可以產生更高的變化？我想，從商業角度來說，您最初的感覺是什麼樣的呢？您的業務將如何發展？

Yes. Thanks, Joe. The -- well, so the questions around -- everybody's question is around what can we replace today and then what's more aspirational. So I think that it would be very difficult to replace all animal models today given what's used, but a good deal of usage could be replaced. So we've launched a product called Non-Animal Navigator, which combines both our QSP capabilities and our drug development capabilities with the idea that we can use QSP models to inform dosing on things like monoclonal antibodies and eliminate a lot of the preclinical use of animal models.

是的。謝謝，喬。嗯，所以周圍的問題都是關於今天我們可以取代什麼，以及什麼更有抱負。因此我認為，考慮到目前所使用的動物模型，要取代所有的動物模型是非常困難的，但很大一部分用途是可以被取代的。因此，我們推出了一款名為非動物導航器的產品，它結合了我們的 QSP 能力和藥物開發能力，我們可以使用 QSP 模型來指導單株抗體等藥物的劑量，並消除大量臨床前動物模型的使用。

In the longer run -- well, as I said, the other piece of this is around toxicology, we have QSP and some of our toxicology models can inform the decisions that need to be made there in preclinical. As you get into like longer run studies, those could be hard to eliminate right away, but those are not really the focus of everybody right now. So hopefully, that gives you a little bit of color there.

從長遠來看 — — 正如我所說，這其中的另一部分是關於毒理學的，我們有 QSP，我們的一些毒理學模型可以為臨床前需要做出的決策提供資訊。隨著研究的深入，這些問題可能很難立即消除，但這些問題目前並不是大家真正關注的重點。希望這能帶給你一些色彩。

Yes, that's great. And then Obviously, the question that's coming up is how big of a dollar opportunity could this ultimately be for the biosimulation space. It might just be too soon to say, but maybe I'll ask I think about how Certara has traditionally framed the growth in their business and kind of the parameters of 10% to 15% over time. Would you kind of view the recent road map as increasing the confidence on sustaining 10% to 15%? Or do you really think this could be a shift up entirely and so it results in a number above the 10% to 15% range?

是的，太棒了。那麼顯然，接下來的問題是，這最終將為生物模擬領域帶來多大的獲利機會。現在說可能還為時過早，但也許我會問 Certara 傳統上如何定義其業務成長以及隨著時間的推移 10% 到 15% 的參數。您是否認為最近的路線圖增強了維持 10% 至 15% 的信心？或者您真的認為這可能完全是一個轉變，因此導致數字高於 10% 到 15% 的範圍？

Yes. I think it's probably a little bit too early to make that call. The FDA made an announcement that is very encouraging and I think very complementary in terms of the value that Certara can bring to something like this. But it's going to take some time to implement it and want to see how fast that goes. I think that's the key variable there.

是的。我認為現在做出這個決定可能還為時過早。FDA 發布的聲明非常令人鼓舞，我認為這對於 Certara 能為此類事情帶來的價值非常具有補充作用。但實施起來需要一些時間，想看看進展有多快。我認為這是其中的關鍵變數。

As I said, we're already getting -- we got a lot of early interest, but we're talking about a significant change in a regulatory process in a drug development process that can take years. So those will have to roll out as we go forward. I would say, overall, it will be helpful to our growth rate, but I think it's probably too early to kind of give you a number right now.

正如我所說，我們已經得到了很多早期的興趣，但我們正在談論藥物開發過程中監管流程的重大變化，這可能需要數年時間。因此，隨著我們不斷前進，這些都必須逐步推出。我想說，總的來說，這將有助於我們的成長率，但我認為現在給你一個數字可能還為時過早。

Scott Schoenhaus, KeyBanc.

KeyBanc 的 Scott Schoenhaus。

My first question relates to the potential pharma tariffs. Are you having conversations with your customers on this. Is it are they saying it's going to be impacting or they're being more cautious with their budgets going forward? Any color around this potential headwind or tailwind in your view?

我的第一個問題與潛在的藥品關稅有關。您是否正在與客戶討論此事？他們是否說這會產生影響，或者他們會對未來的預算更加謹慎？您認為這種潛在的逆風或順風有哪些特徵？

And then secondly, as a follow-up to the FDA phase-out of animal models. Is it more centered around smaller biotechs that are coming to you around monoclonal antibody preclinical studies? Or is it larger in terms of your larger more -- sorry, broader in terms of your larger customer base?

其次，作為 FDA 逐步淘汰動物模型的後續行動。它是否更集中在圍繞單株抗體臨床前研究與您聯繫的小型生物技術公司？或者就您的更大範圍而言，它是否更大 — — 抱歉，就您的更大客戶群而言，它是否更廣泛？

So let me take the second -- we'll stick on the animal models first. I'll take the second question first. So -- we had a webinar last week. We had, I think, over 800 people responded, and the mixture was as we tracked it was everything from biotech to large pharma companies to even people and government agencies as well. So the interest has been quite broad in using the technology to eliminate animal models.

那麼讓我來談談第二點——我們先討論動物模型。我先回答第二個問題。所以——我們上週舉辦了一次網路研討會。我認為，我們收到了超過 800 人的回复，而且根據我們的追踪，回复者來自各個領域，從生物技術公司到大型製藥公司，甚至還有個人和政府機構。因此，人們對利用該技術消除動物模型的興趣相當廣泛。

On the tariffs. Yes. For Tier 1 customer tariffs, then we had already seen slowness in decision-making as it relates to like Q1 performance. And you'd see that show up in our Tier 1 biosim services. But I wouldn't say that we'd call out anything specific -- any specific difference in customer behavior than what we've seen to date, at least not yet.

關於關稅。是的。對於一級客戶關稅，我們已經看到與第一季業績相關的決策緩慢。您會在我們的一級生物相似藥服務中看到這一點。但我不會說我們會指出任何具體的事情——與我們迄今為止所看到的客戶行為有任何具體的不同，至少現在還沒有。

Yes. So Certara is isolated directly from the tariffs, nothing we sell would be subject to a tariff. We're selling generally into an R&D market. So tariffs don't really affect that. So not saying there won't be an effect across the broad markets, but it will be some indirect. If it happens, and our customers haven't really been talking about that on us.

是的。因此，Certara 直接與關稅無關，我們銷售的任何商品都不受關稅影響。我們的產品主要銷往研發市場。因此關稅實際上不會對此產生影響。因此，並不是說它不會對整個市場產生影響，但它會產生一些間接影響。如果發生了這種情況，我們的客戶實際上並沒有談論過我們。

Okay. That's helpful. Yes, it was more of the derivative impact on the R&D budgets and what it could mean. So that's really helpful. I appreciate all the color there.

好的。這很有幫助。是的，這更多的是對研發預算的衍生影響及其可能意味著什麼。這真的很有幫助。我很欣賞那裡的所有色彩。

David Windley, Jefferies.

傑富瑞的戴維溫德利 (David Windley)。

Hi, thanks for taking my questions. Good afternoon. Will, you talked a fair amount in the past about kind of the inertia in pharma drug development in the way they do things. It sounds like the FDA announcement of both, I guess, the initial Pedone 2 approval and then this more recent announcement or a nice shot in the arm to try to break some of that inertia. My understanding is that maybe the FDA is reaching out to a -- I'm not sure how long the list, but a pilot list of drug developers to try to engage around this new thinking. So I have several questions.

你好，謝謝你回答我的問題。午安.威爾，你過去曾多次談論製藥藥物開發過程中的慣性。我想，這聽起來像是 FDA 宣布的兩項舉措，首先是最初的 Pedone 2 批准，然後是最近的這項公告，或者是一劑強心針，試圖打破一些惰性。我的理解是，FDA 可能正在聯繫一份——我不確定名單有多長，但這是一份藥品開發商試點名單，試圖圍繞這一新思維進行嘗試。我有幾個問題。

One, I guess, is thinking about what do you think is the key to kind of move pharma off its perch and get confident and comfortable in the regulator's willingness to truly accept this stuff? Does it take an approval of a drug that has gone through a no animal or an animal light drug development cycle?

我想，首先要思考的是，您認為讓製藥公司擺脫困境，並對監管機構願意真正接受這些東西充滿信心和信心的關鍵是什麼？是否需要經過無動物實驗或輕度動物實驗的藥物開發週期的藥物獲得批准？

Two, in terms of kind of the evolution or the replacement of an IND-enabling package like what do you think that looks like in the future? And where does Certara's software, like what parts of that package can you insert yourself into and replace what is currently answered through animal data? Thanks.

二、就 IND 支援包的演變或替換而言，您認為未來會是什麼樣子？那麼 Certara 軟體的哪些部分可以插入到其中並替換目前透過動物數據回答的問題呢？謝謝。

Okay. All right. So several parts to that question. So the first one I heard was what's key to move Pharma off its current perch. And I think that there are two things. One is the FDA is continuing to expand upon their original announcement. And they've been -- they've talked about, they would both encourage the use of alternative technologies and potentially discourage people who didn't move. So I think the industry is looking for some more information about how that will play out.

好的。好的。這個問題可以分為幾個部分。所以我聽到的第一個問題是，讓製藥業擺脫目前的地位的關鍵是什麼。我認為有兩件事。一是 FDA 正在繼續擴大其最初的公告。他們一直在談論，他們既會鼓勵使用替代技術，也可能會勸阻那些不願意搬家的人。因此我認為業界正在尋找更多有關這種情況將如何發展的資訊。

I think that practically speaking, it does take an approval, but FDA specifically called out monoclonal antibodies and other drugs. I think monoclonal antibodies are one area in which the use of animal models has been highly questioned and the technology is fairly advanced in using alternatives. So that's a good thing.

我認為從實際角度來說，它確實需要批准，但 FDA 特別提到了單株抗體和其他藥物。我認為單株抗體是使用動物模型受到高度質疑的一個領域，並且在使用替代品方面技術相當先進。這是一件好事。

There are drugs that have gone to the FDA that effectively have not used animals, not monoclonal antibodies, but things like if you often if you take a gene therapy and to an IND right now, it really doesn't make a lot of sense to use an animal model on the technology like that. And so there are examples where the FDA has effectively used -- use modeling in lieu of animals because it just didn't make any sense to use animals. So I think that's some early signs of which way things may go for -- as this expands.

有些已經提交給 FDA 的藥物實際上並沒有使用動物，也沒有單株抗體，但是如果你經常進行基因治療並且現在進行 IND，那麼在這樣的技術上使用動物模型真的沒有多大意義。因此，有一些例子表明 FDA 有效地使用模型來代替動物，因為使用動物根本沒有任何意義。所以我認為這是事態發展的一些早期跡象——隨著事態的擴大。

In terms of the evolution of the IND package. My thinking on this is that, broadly speaking, animal models are used in really in three ways as the IND goes through. So one is in the basic first-in-human dosing. In that case, the models today are better than, in many cases, than what you can do with animals anyway, so -- or at least they are in monopoly antibodies.

就 IND 包的演變而言。我的想法是，廣義上講，在 IND 進行過程中，動物模型實際上以三種方式使用。因此，第一個是基本的首次人體給藥。在這種情況下，今天的模型在許多情況下都比用動物做的要好，或者至少它們在抗體方面是壟斷的。

So I think that we're pretty well positioned to make a good argument to our customers that we've got technology there that continue to use some animals that the FDA is going to discourage that is more than feasible and you can go faster and everybody, it will be more efficient and lower cost.

因此，我認為我們完全有能力向客戶證明，我們擁有的技術可以繼續使用 FDA 不鼓勵的某些動物，這是完全可行的，而且可以加快速度，對每個人來說都會更有效率、成本更低。

Second piece is on toxicology. So looking at things like liver tox, cardiotox, things like that. For those -- the models exist, probably they can be improved over time now that people have gotten a lot more interest in this area. They can be tied into -- if you look at the FDA's announcement, they talk about organ on a chip technology so we can tie into the companies that are working on that.

第二部分是關於毒理學的。因此，請注意肝毒性、心臟毒性等。對於那些已經存在的模型，隨著人們對這一領域的興趣越來越濃厚，它們可能會隨著時間的推移而得到改善。它們可以與——如果你看一下 FDA 的公告，他們談到了晶片器官技術，所以我們可以與正在研究該技術的公司聯繫起來。

And so what I'd say on that is we have pretty good modeling capabilities in those areas, but tox is a big area. And we could probably make bigger investments and expand on that since this will be a new area. And I'd say the third part, which is probably the longest part out is kind of the long-term studies, things like you're looking for long-term cancer or something like that.

所以我想說的是，我們在這些領域擁有相當不錯的建模能力，但毒理學是一個很大的領域。由於這是一個新領域，我們可能會進行更大的投資並擴大其規模。我想說的是第三部分，這可能是最長的部分，是一種長期研究，例如你正在尋找的長期癌症或類似的東西。

Those are the hardest to replace all the animals just because by -- almost by definition, you're looking for something that nobody has modeled, but they're also not the largest use of the animal. So I'm guessing -- I don't know how the FDA is going to think about that, but my guess is they're going to probably put that part of it off as new technologies become available.

這些是最難取代所有動物的，因為根據 - 幾乎根據定義，你在尋找一些沒有人模仿過的東西，但它們也不是動物的最大用途。所以我猜測——我不知道 FDA 會如何考慮這個問題，但我的猜測是，隨著新技術的出現，他們可能會推遲這部分工作。

So we know they're looking for modeling. They're looking at -- they specifically mentioned things like organ on a chip. And they're looking for new modeling, new technologies that can replace this and they're generally favoring in making a change in that way. So long answer, David, but hopefully, I got a lot of your parts of your question there.

所以我們知道他們正在尋找模特兒。他們正在研究——他們特別提到了諸如晶片上的器官之類的東西。他們正在尋找可以取代這種模式的新模型、新技術，並且他們普遍傾向於以這種方式做出改變。大衛，回答得真長，但希望我已經理解了你的大部分問題。

Dan Leonard, UBS.

瑞銀的丹·倫納德（Dan Leonard）。

First, a cleanup question. On the services business, it sounds like regulatory is now a good guy in comparison to biosimulation services and I'm wondering why that would be.

首先，清理問題。就服務業務而言，與生物模擬服務相比，監管現在聽起來是個好主意，我想知道為什麼會這樣。

Well, a couple of things there. Most importantly, we've fully built out our commercial team. The commercial team is executing very well across the Board, including in regulatory, so we've been very pleased with the performance there. And then when you look at -- when you look at last year, then it's important to keep in mind that we were hitting some low spots last year and so the compares that we have are easier as well.

嗯，有幾件事。最重要的是，我們已經全面組建了我們的商業團隊。商業團隊在各方面表現都非常出色，包括在監管方面，因此我們對那裡的表現非常滿意。然後，當你回顧——當你回顧去年時，重要的是要記住，去年我們遇到了一些低谷，因此，我們進行的比較也更容易。

And then just to follow up again on this FDA bit. Is it possible at all to compare and contrast your inbound activity and interest following the passage of the FDA Modernization Act 2.0 a few years ago with what you're experiencing today following the most recent updated FDA discussion?

然後再跟進一下 FDA 的情況。是否可以將幾年前 FDA 現代化法案 2.0 通過後您的入境活動和興趣與您今天在最近更新的 FDA 討論後所經歷的情況進行比較和對比？

Yes. What I would say is the FDA Modernization Act was passed by Congress, but industry didn't do very much because the FDA didn't say very much. So the difference now is that the FDA has set a very clear signal about what they are really intending to do and they're sending it to the market and I guess, to their examiners, which isn't really the situation we had a couple of years ago. So I would say a couple of years ago, I would have characterized as Congress said that the FDA could do something, but they didn't move at that time to do it.

是的。我想說的是，《FDA 現代化法案》已獲國會通過，但由於 FDA 沒有發表太多言論，因此業界並沒有做出太大的貢獻。所以現在的不同之處在於，FDA 已經對他們真正打算做什麼發出了非常明確的信號，並將其發送到市場，我想，也發送到他們的審查員，這與幾年前的情況不同。所以我想說，幾年前，我會認為國會說 FDA 可以做些什麼，但他們當時並沒有採取行動。

Jeff Garro, Stephens.

傑夫加羅、史蒂芬斯。

Yes. Maybe one more on the Non-Animal Navigator product. I recognize it's very early and you have a big event this week and that will be a key topic there. But I wanted to ask further about how the pipeline has been building for that offering. And if you could put a timeline on potential financial impact, such as the first contract booking related to that product?

是的。也許還有一篇關於非動物導航產品的文章。我知道現在還為時過早，而且本週你們有一個大型活動，這將是其中的關鍵話題。但我想進一步詢問該產品的通路建立情況。您是否可以對潛在的財務影響制定時間表，例如與該產品相關的第一份合約預訂？

So I'll take the last part first, and Will can fill in if there's something I missed there. But as far as when and how much it's -- it's early for us to tell. The key areas of products that we're focused on are obviously our QSP offerings and the Simcyp offering.

因此，我將首先討論最後一部分，如果我遺漏了什麼，威爾可以補充。但至於何時以及數量多少——現在我們還不能確定。我們關注的重點產品領域顯然是我們的 QSP 產品和 Simcyp 產品。

And we're getting a lot of inbound interest, as Will had said earlier. But it's really too early to tell and feels. It feels like something that we'd look beyond Q2. But stay tuned, we need to see it in the performance and then we'll be able to give you an update.

正如威爾之前所說，我們收到了很多關注。但現在說這些還太早。這感覺就像是我們會關注第二季之後的事情。但請繼續關注，我們需要在表演中看到它，然後我們才能為您提供更新。

Makes sense. And on the prepared remarks, you mentioned client AI spend as a tailwind. So I was hoping you could elaborate on your continued effort to infuse your products with AI and whether your investments there are being recognized as a differentiator in the market.

有道理。在準備好的評論中，您提到客戶 AI 支出是順風。所以我希望您能詳細說明您在將人工智慧融入產品方面所做的持續努力，以及您在那裡的投資是否被認可為市場差異化因素。

Yes. Thanks for the question. So we -- last year, we launched a couple of AI products. One of the major ones was our co-author product, which is used in basically writing regulatory reports, but will eventually write other reports as well across our software portfolio. And we have some other products we put out last year, and there's a couple coming out this year.

是的。謝謝你的提問。因此，我們——去年，推出了幾款人工智慧產品。其中一個主要產品是我們的合著產品，它主要用於編寫監管報告，但最終也將在我們的軟體組合中編寫其他報告。我們去年也推出了一些其他產品，今年還會推出幾款產品。

The ones we launched last year have meaningful revenues. So we're pleased with the growth rate there. They also, as I kind of referenced in my talk, attract a lot of attention from our customers. So everybody is trying to figure out what AI means and they're really good for getting in to have conversations with customers who want to see the latest the greatest.

我們去年推出的產品都帶來了可觀的收入。所以我們對那裡的成長率感到滿意。正如我在演講中提到的那樣，它們也吸引了大量客戶的注意。因此，每個人都在試圖弄清楚人工智慧的含義，並且他們非常擅長與想要了解最新和最棒事物的客戶進行交談。

So -- and then generally, we can often move on to a more comprehensive discussion around our whole portfolio as well. So I think it's all good for Certara. I think you always have to remember that a couple of years ago, none of us really were thinking -- No, nobody was really thinking about GPT based AI and then the world kind of woke up very quickly.

所以 — — 一般來說，我們通常也可以就我們的整個投資組合進行更全面的討論。所以我認為這對 Certara 來說都是好事。我認為你必須永遠記住，幾年前，我們中沒有人真正考慮過——不，沒有人真正考慮過基於 GPT 的人工智慧，然後世界很快就醒了過來。

So there's just a tremendous amount of experimentation, a fairly large budgets being devoted to that as that kind of experimentation phase shapes out, there's going to be a set of companies and products that clearly generate money, and that's really what we're focused on doing. So we're not trying to be a general AI company, but we are intending to really enhance the growth of biosimulation by bringing AI to the technology we already have.

因此，我們需要進行大量的實驗，投入相當多的預算，隨著這種實驗階段的逐漸成熟，將會有一系列能夠明顯賺錢的公司和產品，而這正是我們真正關注的事情。因此，我們並不是想成為一家通用人工智慧公司，而是打算透過將人工智慧引入我們現有的技術來真正促進生物模擬的發展。

And we think if we do that, then there's plenty of value to be generated for our customers, and that will be good for Certara as well.

我們認為，如果我們這樣做，那麼我們就可以為客戶創造很多價值，這對 Certara 來說也是好事。

Max Smock, William Blair.

馬克斯史莫克、威廉布萊爾。

It's Christine Rains for Max Smock. So two for us. The first one, again, related to the preclinical animal testing space. Just hoping you can comment on what percentage of your current both small and large pharma customers utilize your software and services for preclinical applications today? Just trying to get an idea of where penetration is versus your clinical offerings. And what do you think is a reasonable trajectory over the coming few years?

我是 Max Smock 的 Christine Rains。所以對我們來說是兩個。第一個問題再次與臨床前動物試驗領域有關。只是希望您能評論一下目前有多少比例的小型和大型製藥客戶使用您的軟體和服務進行臨床前應用？只是想了解一下滲透率與臨床服務之間的差異。您認為未來幾年的合理發展軌跡是什麼？

So we haven't broken out the proportion of revenue by preclinical versus clinical. But we have said that historically, the majority of our revenue is coming in the clinical phases. So obviously, with Chemaxon, we're expanding our footprint into discovery and a portion of the legacy Certara business wasn't preclinical, all of this would expand that.

因此，我們還沒有按臨床前和臨床細分收入比例。但我們說過，從歷史上看，我們的大部分收入來自臨床階段。因此，顯然，透過 Chemaxon，我們將把業務範圍擴大到發現領域，而部分 Certara 原有業務並非臨床前業務，所有這些都將擴大這一領域。

Great. And then relatedly, can you talk about any additional plant investments that you're making or planning to make in building out your preclinical offerings and what areas? And relatedly, how should we think about your newly launched on the Non-Animal Navigator solution? Is it more of a repackaging of your existing software and services that are mostly applicable to the preclinical space? Or is there anything in the solution that you previously did not offer?

偉大的。然後，相關地，您能否談談您在擴展臨床前產品方面正在進行或計劃進行的任何額外工廠投資以及哪些領域？與此相關的是，我們應該如何看待您新推出的非動物導航解決方案？它是否更像是主要適用於臨床前領域的現有軟體和服務的重新包裝？或者解決方案中是否存在您之前未提供的內容？

Well, we have been investing pretty aggressively in the development of our QSP group and technology and software. A lot of that is tied to preclinical and effectively directly falls into the category of what we're talking about in Non-Animal usage share. Non-Animal Navigator was intended to be a combination of that plus some of our drug development strategists who basically can explain new customers, what is the new -- and also our regulatory experts too.

嗯，我們一直在積極投資 QSP 集團、技術和軟體的開發。其中許多都與臨床前相關，並且實際上直接屬於我們在非動物用途份額中討論的類別。非動物導航員的目的是將其與我們的一些藥物開發策略師結合起來，這些策略師基本上可以向新客戶解釋什麼是新產品——當然還有我們的監管專家。

We can explain to customers exactly what is the situation, how do you come up with a plan for your preclinical development leading it into IND under the new thinking with the FDA and then how do you implement that using software like our QSP team? So I don't know -- I would say that we moved quickly to put several other key pieces that you need for this that were already available in Certara together. And I think that will be a winning combination.

我們可以向客戶準確地解釋情況，您如何根據 FDA 的新思路制定臨床前開發計劃並將其引入 IND，然後如何使用像我們的 QSP 團隊這樣的軟體來實現這一目標？所以我不知道——我想說的是，我們迅速採取行動，將您所需的其他幾個關鍵部分放在一起，這些部分已經在 Certara 中提供。我認為這將會是一個成功的組合。

And one point I might add as well, too, is that the addition of applied biomass at the tail end of 2023, really gave Certara the combination of our existing QSP practice, plus applied biomass and having been together for more than a year now, positions Certara with a market-leading stance in QSP which as Will just said, it's going to be a key component to capitalizing on the opportunity in front of us.

我還要補充一點，2023 年底增加的應用生物質確實為 Certara 提供了我們現有的 QSP 實踐與應用生物質的結合，並且經過一年多的合作，Certara 在 QSP 市場中處於領先地位，正如威爾剛才所說，這將成為利用我們面前的機會的關鍵組成部分。

Constantine Davides, Citizens.

康斯坦丁大衛斯，公民。

Just changing gears a little bit. Just wondering if you can give us a little bit of an update now on Certara Cloud. It's been a few quarters since you've rolled that out. And just give us some sense for how that's scaling and what kind of engagement or behavior you're starting to see that spur.

只要稍微改變一下節奏。只是想知道您是否可以向我們提供有關 Certara Cloud 的一些最新消息。自從你們推出這個計劃以來已經過了幾個季度了。請讓我們了解它的規模如何，以及您開始看到什麼樣的參與或行為產生這種推動作用。

Yes. So we're pleased with the take rate on cloud. In fact, it's really just a component of pushing the software update across. So when Phoenix customers are renewing their licenses, they're accessing their new log-ins, they are accessing Certara Cloud, which is providing them obviously access to the software they've already purchased, but all of the software that we offer. And so the value proposition of Certara Cloud is giving the opportunity to see the breadth of the product portfolio.

是的。因此，我們對雲的接受率感到滿意。事實上，它只是推送軟體更新的一個元件。因此，當 Phoenix 客戶更新其許可證時，他們可以訪問新的登入信息，訪問 Certara Cloud，這顯然可以讓他們訪問他們已經購買的軟體，以及我們提供的所有軟體。因此，Certara Cloud 的價值主張提供了一個了解產品組合廣度的機會。

And given the many, many customers, we have for a product like Phoenix that's turning over on an annual renewal basis, then we have a pretty strong presence in Certara Cloud as we sit here now.

考慮到我們 Phoenix 等產品擁有眾多客戶，這些客戶每年都會進行更新，因此我們在 Certara Cloud 中擁有相當強大的影響力。

And I guess just a follow-up there on the Phoenix. I know you're trying to move a little bit more of that base to a hosted solution. Where does that kind of sit now? And -- how should we think about how that's going to trend over the next few years?

我想這只是對鳳凰號的後續報導。我知道您正在嘗試將更多的基礎轉移到託管解決方案。現在這種情況如何？並且──我們該如何看待未來幾年的趨勢？

We're still in the earlier inning of the conversion. And so -- the good news there is part of the R&D investment that we're making in the software portfolio during this year is putting in enhancements and added functionality to the Phoenix hosted product that will be attractive to our customers. And so we're expecting that the take rate on shifting to hosted will increase, but it's still going to take some time.

我們仍處於轉換的早期階段。因此，好消息是，我們今年在軟體產品組合上進行的部分研發投資將用於增強和增加 Phoenix 託管產品的功能，這將對我們的客戶具有吸引力。因此，我們預計轉向託管的接受率將會增加，但這仍然需要一些時間。

Brendan Smith, TD Cowen.

布倫丹·史密斯（Brendan Smith），TD Cowen。

This is [Jacqueline] on for Brendan. Given the reiterated guidance, where does this you see the opportunity for potential upside within the software business in fiscal year '25 as well as within services?

我是 [Jacqueline]，為 Brendan 服務。鑑於重申的指導，您認為 25 財年軟體業務以及服務領域的潛在上昇機會在哪裡？

Yes. I mean -- so the upside opportunity are all the good things that we've been talking about here related to the shift away from animal testing. We just talked about some of the investments in the software product platforms that are going to drive additional adoption by customers. So there's a lot of optimism and excitement to see one of the key questions here, of course, has been what's the timing that this will play out, and it's early, but we have a lot of inbound interest. And that's really what drives the upside.

是的。我的意思是——所以，我們在這裡談論的與擺脫動物試驗有關的所有好事都是有利的。我們剛剛談到了對軟體產品平台的一些投資，這些投資將推動客戶進一步採用這些產品。因此，人們對看到這一進展感到非常樂觀和興奮。當然，這裡的一個關鍵問題是，這項進展將在什麼時候發生，雖然現在還為時過早，但我們對此非常感興趣。這才是真正推動上漲的因素。

But the counterbalance to that, which is important is that we continue to operate in an end market environment that's significant challenge. So while we're optimistic we're executing very well, which we saw evidence of in the bookings in Q1.

但與此相對應、重要的一點是，我們將繼續在充滿重大挑戰的終端市場環境中運作。因此，雖然我們很樂觀，但我們的執行情況非常好，我們在第一季的預訂中看到了證據。

But the counterbalance to that is the end market environment, think of biotech funding, think of Tier 1 pharma slowness and decision-making, all of which is a carryover from what we experienced in 2024 and was a component of our guidance as we moved into this year that we expected more of the same in the end markets from 2024 carrying over into 2025, and that's exactly what we've experienced so far.

但與此相反的是終端市場環境，想想生物技術融資，想想一級製藥公司的緩慢和決策，所有這些都是我們在 2024 年經歷的延續，也是我們進入今年時的指導方針的一部分，我們預計 2024 年的終端市場將延續到 2025 年，而這正是我們迄今為止所經歷的。

That's great. And I'll just hop on the bandwagon here for just a quick follow-up on the FDA announcement. Do you have any thoughts on how the FDA will select platforms to include in their upcoming pilot studies?

那太棒了。我只是想順勢而為，快速跟進 FDA 的公告。您對 FDA 將如何選擇平台納入其即將進行的試點研究有何看法？

We're -- well, I think it's too hard to talk for the FDA. I think that will be coming out. They're obviously very interested in this and they're talking with a lot of companies. So let's see what they do.

我們——嗯，我認為這對 FDA 來說太難了。我認為那終將實現。他們顯然對此非常感興趣，並且正在與許多公司進行洽談。那麼讓我們看看他們做了什麼。

Vikram Purohit, Morgan Stanley.

摩根士丹利的維克拉姆·普羅希特（Vikram Purohit）。

This is [Proton] on for Vikram. Just on FDA announcement, do you guys contemplate on adding different types of software programs to kind of as time goes on to kind of help push out this Non-Animal Navigator product?

這是為維克拉姆 (Vikram) 開啟的 [Proton]。就在 FDA 公告中，你們是否考慮隨著時間的推移添加不同類型的軟體程式來幫助推出這種非動物導航產品？

Yes. Thanks for the question. It's only a couple of weeks out. So we are we're thinking a lot about that. There's an opportunity here for Certara. There's an opportunity to make certain types of investments, but we haven't announced anything yet. So we'll let you know when we're ready.

是的。謝謝你的提問。只剩幾週時間了。所以我們對此進行了深入思考。這對 Certara 來說是一個機會。有機會進行某些類型的投資，但我們尚未宣布任何消息。當我們準備好時我們會通知您。

Thank you. This concludes our question-and-answer session and today's conference call. Thank you for participating, and you may all disconnect.

謝謝。我們的問答環節和今天的電話會議到此結束。感謝您的參與，現在您可以斷開連接了。