Rapid Micro Biosystems Inc (RPID) 2023 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by. My name is Natalie, and I will be your conference operator today. At this time, I would like to welcome everyone to the Rapid Micro BioSystems Fourth Quarter and Full Year 2020 earnings. (Operator Instructions) I would now like to turn the conference over to Mike Beaulieu, Investor Relations. Please go ahead.

女士們先生們，謝謝你們的支持。我叫娜塔莉，今天我將擔任你們的會議操作員。此時此刻，我謹歡迎大家關注 Rapid Micro BioSystems 2020 年第四季和全年財報。（操作員指示）我現在想將會議轉交給投資者關係部門的 Mike Beaulieu。請繼續。

Good morning and thank you for joining the Rapid Micro BioSystems Fourth Quarter and Full Year 2023 earnings call. Joining me on the call are Rob Cygnus, the President and Chief Executive Officer, and Sean Ortiz, Chief Financial Officer. Earlier today, we issued a press release announcing our fourth quarter and full year 2023 financial results. A copy of the release is available on the Company's website at Rapid Micro bio.com under investors in the News and Events section.

早安，感謝您參加 Rapid Micro BioSystems 2023 年第四季和全年財報電話會議。與我一起參加電話會議的還有總裁兼執行長 Rob Cygnus 和財務長 Sean Ortiz。今天早些時候，我們發布了新聞稿，宣布了 2023 年第四季和全年財務業績。新聞稿的副本可在本公司網站 Rapid Micro bio.com 的「投資者」下的「新聞和活動」部分取得。

Before we begin, I'd like to remind you that many statements made during this call may be considered forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements, including but not limited to, statements relating to rapid microbiomes financial condition, anticipated future cash usage and cash runway guidance for 2024, including revenues, expenses, gross margin, system placements and validation activities, expectations for and planned activities related to the Company's business development and growth customer interest and adoption of the Growth Direct system statements regarding the planned launch and commercialization of rapid sterility and the potential impact of macroeconomic uncertainty on rapid Micro's business, actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors For a list and description of the risks and uncertainties associated with rapid Micro's business, please refer to the Risk Factors section of our most recent annual report on Form 10 K filed with the Securities and Exchange Commission as updated from time to time in our subsequent filings with the SEC. We urge you to consider these factors, and you should be aware that these statements should be considered estimates only and are not a guarantee of future performance and this conference call contains time-sensitive information and is accurate only as of the live broadcast today, March first, 2024. Rapid Micro disclaims any intention or obligation, except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.

在我們開始之前，我想提醒您，本次電話會議中所做的許多陳述可能被視為聯邦證券法含義內的前瞻性陳述，這些陳述是根據美國《私人證券訴訟改革法案》的安全港條款做出的。1995 年。本次電話會議中包含的與未來事件、結果或業績的預期或預測相關的任何聲明均為前瞻性聲明，包括但不限於與快速微生物組財務狀況、預期未來現金使用情況和2024 年現金跑道指導相關的聲明，包括收入、費用、毛利率、系統佈局和驗證活動、與公司業務發展和增長相關的預期和計劃活動、客戶興趣以及增長直接系統的採用有關快速無菌的計劃啟動和商業化以及潛在影響的聲明由於宏觀經濟不確定性對rapid Micro業務的影響，由於多種因素，實際結果可能與前瞻性陳述中明示或暗示的結果存在重大差異。有關與rapid Micro業務相關的風險和不確定性的清單和描述，請參閱我們向美國證券交易委員會提交的最新 10 K 表格年度報告中的「風險因素」部分，在我們隨後向美國證券交易委員會提交的文件中會不時更新。我們敦促您考慮這些因素，並且您應該知道，這些陳述應僅被視為估計，並不能保證未來業績，本次電話會議包含時間敏感信息，僅截至今天（三月）直播時準確。第一， 2024 年。Rapid Micro 不承擔任何意圖或義務，除非法律要求更新或修改任何財務預測或前瞻性陳述，無論是因為新資訊、未來事件或其他原因。

And with that, I'll turn the call over to Rob.

然後，我會將電話轉給 Rob。

Thank you, Mike. Good morning, everyone, and thank you for joining us. I will begin this morning's call with an overview of our fourth quarter 2023 performance and highlights followed by a review of our growth strategy for 2024. I'll then turn the call over to Sean for a more detailed review of our financial results and outlook. Total revenue was $6.3 million in the fourth quarter, representing growth of 45% and $22.5 million for the full year 2023, representing growth of 31% compared to the prior quarter and year, respectively.

謝謝你，麥克。大家早安，感謝您加入我們。我將在今天早上的電話會議中概述我們 2023 年第四季的業績和亮點，然後回顧我們的 2024 年成長策略。然後我會將電話轉給肖恩，以更詳細地審查我們的財務表現和前景。第四季總營收為 630 萬美元，較上一季和上年同期分別成長 45% 和 2,250 萬美元。

We placed six Growth Direct systems in Q4 for a total of 16 for the year. These results exceeded our guidance for both the quarter and the year and reflect strong, consistent commercial execution and the robustness of our growth strategy. Also in our fourth quarter results, we were pleased to report that we made significant progress and achieved near breakeven gross margins, which we believe represents a positive inflection in our financial profile.

我們在第四季度放置了 6 個 Growth Direct 系統，全年總數為 16 個。這些結果超出了我們對本季和本年度的指導，反映了強大、一致的商業執行力和我們成長策略的穩健性。同樣在第四季度的業績中，我們很高興地報告說，我們取得了重大進展，毛利率接近收支平衡，我們認為這代表了我們財務狀況的積極轉變。

This performance is a result of the efforts of our manufacturing operations and service teams who have been aggressively focused on reducing costs, enhancing efficiency and productivity. On a cumulative basis, through the end of 2023, we have placed 141 Growth Direct systems globally, including 121 fully validated systems and have shipped nearly 5 million consumables.

這項業績是我們的製造營運和服務團隊努力的結果，他們一直積極致力於降低成本、提高效率和生產力。截至 2023 年底，我們已累計在全球部署了 141 個 Growth Direct 系統，其中包括 121 個經過充分驗證的系統，並已發貨近 500 萬件耗材。

Our customer base now includes 70% of the global top 20 pharmaceutical manufacturers and many of the largest global CDMOs, including Samsung Biologics, who recently selected the Growth Direct system to automate their critical microbial quality control testing. We have also placed Growth Direct systems with 100% of the manufacturers of commercially approved CAR T therapies. Manufacturing of these life-saving therapies requires accuracy for automation and fast turnaround, which are hallmarks of the Growth Direct. We are very proud to be the trusted partners with these leading companies for the mission critical microbial quality control processes.

我們的客戶群現在包括 70% 的全球 20 強製藥商和許多全球最大的 CDMO，其中包括三星生物製品公司 (Samsung Biologics)，該公司最近選擇了 Growth Direct 系統來自動化其關鍵微生物品質控制測試。我們也向 100% 商業核准的 CAR T 療法製造商放置了 Growth Direct 系統。這些挽救生命的療法的製造需要自動化的準確性和快速週轉，這是 Growth Direct 的標誌。我們非常自豪能夠成為這些領先公司在關鍵任務微生物品質控制流程方面值得信賴的合作夥伴。

As we turn to 2024. Our priorities remain consistent with 2023. First, accelerating growth. Direct system placements remains our highest priority. Our second priority is improving gross margins and driving towards profitability. Our third priority is developing and commercializing innovative new products, which in the context of 2024 means achieving the successful launch and commercialization of rapid sterility. And finally, we remain focused on prudently managing our cash success in achieving our 20 top24 priority of accelerating system placements is a function of the size and quality of our sales funnel, which remains many multiples of our forecast during 2023, our system placements were a balanced mix of new versus existing customers and single versus multi-system orders.

當我們轉向 2024 年。我們的優先事項與 2023 年保持一致。一是加快成長。直接系統安置仍然是我們的首要任務。我們的第二要務是提高毛利率並實現獲利。我們的第三個優先事項是創新新產品的開發和商業化，這在2024年的背景下意味著實現快速無菌的成功上市和商業化。最後，我們仍然專注於謹慎管理我們的現金成功，以實現我們加速系統佈局的20 個top24 優先事項，這是我們銷售漏斗的規模和質量的函數，這仍然是我們在2023 年預測的許多倍，我們的系統佈局是新客戶與現有客戶以及單系統訂單與多系統訂單的平衡組合。

We also achieve a balanced mix of sales into biologics cell and gene therapies and small molecules, which reflects a global market opportunity. Accelerating system placements is also a function of the coverage and capability of our commercial organization where we have been investing in our global sales and marketing teams as well as critical enablement activities such as sales tools and training. We exited 2023 with solid momentum, including two thirds of 2023 systems being placed in the second half of the year and productivity from all three of our sales regions.

我們也實現了生物製劑細胞和基因療法以及小分子的銷售平衡組合，這反映了全球市場機會。加速系統部署也是我們商業組織的覆蓋範圍和能力的功能，我們一直在投資我們的全球銷售和行銷團隊以及銷售工具和培訓等關鍵支援活動。我們以強勁的勢頭結束了 2023 年，其中包括下半年部署的 2023 年系統的三分之二以及我們所有三個銷售區域的生產力。

And finally, we continue to leverage our strong relationships and a strong track record with our customers through reference selling as we strive to make it go directly industry standard for MQC. testing, all of this gives us confidence in our ability to execute against this priority and meet or exceed our 2024 targets.

最後，我們繼續透過參考銷售來利用我們與客戶的牢固關係和良好記錄，努力使其直接成為 MQC 的行業標準。測試，所有這些讓我們對執行此優先事項並達到或超過 2024 年目標的能力充滿信心。

Turning to gross margin improvement, we were pleased with the progress we made during 2023 to take cost out of our product manufacturing processes and operate more efficiently and in the fourth quarter began to see some of the early benefits of these actions dropped down the P&L. In fact, our cost of revenue in Q4 decreased by 7%, while revenue increased by 45% compared to the same period last year driving gross margin to near breakeven. We think this is the start of a positive inflection point and demonstrates a significant leverage in our business model.

談到毛利率的改善，我們對 2023 年在降低產品製造流程成本和提高營運效率方面取得的進展感到高興，並且在第四季度開始看到這些行動的一些早期效益降低了損益表。事實上，我們第四季的營收成本下降了 7%，而營收與去年同期相比成長了 45%，毛利率接近盈虧平衡。我們認為這是一個積極拐點的開始，並展示了我們業務模式的重要影響力。

Looking ahead to 2024. We expect to achieve positive gross margins for the full year as we further scale our business and continue to execute against our cost reduction, efficiency and productivity programs.

展望 2024 年。隨著我們進一步擴大業務規模並繼續執行我們的成本削減、效率和生產力計劃，我們預計全年將實現正毛利率。

Our third priority is developing and commercializing new products to drive growth and provide additional value to our customers. In early January, we announced the upcoming availability of our rapid sterility applications for the Growth Direct system.

我們的第三個優先事項是開發新產品並將其商業化，以推動成長並為客戶提供附加價值。一月初，我們宣布即將推出適用於 Growth Direct 系統的快速無菌應用程式。

As we highlighted in our January press release, our rapid really application can deliver time to organize and detection as little as 12 hours and final time to result and as little as one to three days. These data represent a significant improvement over widely used traditional test methods, which generally require a 14 day endpoint incubation and provide compelling differentiation when compared to current products on the market. Rapid sterility, as with our environmental monitoring, water and bioburden applications offers a compelling value proposition for our customers that includes faster product release more accurate results, improved data integrity, full automation and consistency across their manufacturing networks. This is a breakthrough technology, and we are excited about expanding the direct platform with this new application later this month, we plan to participate in the PDA annual meeting where we will give a technical presentation on our rapid sterility application and engage with both existing and prospective customers we remain on track for a midyear launch and look forward to providing you with updates in the coming quarters.

正如我們在 1 月的新聞稿中所強調的那樣，我們的快速應用程式可以將組織和檢測時間縮短至 12 小時，最終得出結果的時間縮短至一到三天。這些數據代表了對廣泛使用的傳統測試方法的顯著改進，傳統測試方法通常需要 14 天的終點孵化，並且與市場上當前的產品相比提供了引人注目的差異化。與我們的環境監測、水和生物負載應用一樣，快速無菌為我們的客戶提供了令人信服的價值主張，包括更快的產品發布、更準確的結果、改進的數據完整性、整個製造網絡的完全自動化和一致性。這是一項突破性技術，我們很高興能在本月稍後透過這項新應用程式擴展直接平台，我們計劃參加PDA 年會，在會上我們將就我們的快速無菌應用程式進行技術演示，並與現有和潛在客戶，我們仍將在年中推出，並期待在未來幾季為您提供更新。

Wrapping up my prepared remarks, I wanted to share my latest thoughts on Rapid Micro and the growth direct technology. I spent several weeks in January and February connecting with customers.

在結束我準備好的演講時，我想分享我對 Rapid Micro 和成長直接技術的最新想法。一月和二月我花了幾個星期與客戶聯繫。

Now as reminded of the many strong partnerships we have established, I remain confident in the market opportunity and customer demand for the Growth Direct and our strong service and support offerings. These are truly value partnerships within a critical part of our customers' quality and manufacturing processes as we strive to make the growth around the industry standard. We will continue to expand our offerings with innovative products such as rapid sterility and as our platform expands, we will continue to further embed our products and services within our customers' critical quality and manufacturing processes. Our customers recognize a compelling value proposition to automate their QC labs with a product that supports global regulatory requirements.

現在，想起我們建立的許多強大的合作夥伴關係，我對市場機會和客戶對 Growth Direct 的需求以及我們強大的服務和支援產品仍然充滿信心。這些是我們客戶品質和製造流程關鍵部分中真正有價值的合作夥伴關係，因為我們努力圍繞行業標準實現成長。我們將繼續透過快速無菌等創新產品來擴展我們的產品，並且隨著我們平台的擴展，我們將繼續將我們的產品和服務進一步嵌入客戶的關鍵品質和製造流程中。我們的客戶認識到透過支援全球監管要求的產品實現品質控制實驗室自動化的令人信服的價值主張。

Turning back to our strategic outlook, we are excited to build upon our many achievements in 2023. We have a clear set of priorities and are building a track record of strong and consistent execution and innovation. We are confident we have the right strategy and will leverage our successes in 2023 on our path to increasing shareholder value.

回到我們的策略展望，我們很高興能夠在 2023 年取得許多成就。我們有一套明確的優先事項，並正在建立強而有力、一致的執行和創新的記錄。我們相信我們擁有正確的策略，並將利用 2023 年的成功來增加股東價值。

And with that, I'll now turn the call over to Sean to discuss our fourth quarter performance and details for our 2024 guidance.

接下來，我將把電話轉給 Sean，討論我們第四季度的業績和 2024 年指導的詳細資訊。

Sean, thanks, Rob.

肖恩，謝謝，羅布。

Good morning, everyone. I'll start my comments today with a review of our fourth quarter 2023 results and then discuss our 2020 outlook. Q4 revenue increased 45% to $6.3 million compared to $4.4 million in Q4 2022. During the fourth quarter, we placed six Growth Direct systems compared to two in the fourth quarter last year. The six systems this quarter represent the most replaced since Q3 2021. We also completed nine validations in the quarter.

大家，早安。今天我將先回顧我們 2023 年第四季的業績，然後討論我們的 2020 年展望。第四季營收成長 45%，達到 630 萬美元，而 2022 年第四季營收為 440 萬美元。在第四季度，我們放置了六個成長直接系統，而去年第四季只有兩個。本季的六個系統是自 2021 年第三季以來更換最多的系統。我們還在本季完成了九項驗證。

Product revenue, which is comprised of systems and consumables increased 45% to $4.1 million in the quarter, compared to $2.8 million in Q4 last year. The growth in product revenue was primarily driven by the higher number of systems placed in the quarter. Consumable revenue in Q4 increased on a year-over-year basis but was down slightly on a sequential basis due mainly to the timing of customer shipments. Service revenue also increased 45% to $2.2 million in the fourth quarter compared to $1.5 million in Q4 last year. The increase was driven by a higher level of validation activity and higher recurring service contract revenue.

本季由系統和耗材組成的產品收入成長了 45%，達到 410 萬美元，而去年第四季為 280 萬美元。產品收入的成長主要是由於本季安裝的系統數量增加所致。第四季耗材營收年增，但季比略有下降，主要是由於客戶出貨時間的影響。第四季服務收入也成長了 45%，達到 220 萬美元，而去年第四季為 150 萬美元。這一成長是由更高水準的驗證活動和更高的經常性服務合約收入所推動的。

Fourth quarter recurring revenue, which consists of consumables and annual service contracts, increased 13% to $3.3 million compared to $2.9 million in Q4 last year, driven by growth in both consumables and service contract revenue. Nonrecurring revenue was $3.0 million in Q4 compared to $1.5 million in the prior year quarter.

在消耗品和服務合約收入成長的推動下，第四季度的經常性收入（包括消耗品和年度服務合約）成長了 13%，達到 330 萬美元，而去年第四季為 290 萬美元。第四季的非經常性收入為 300 萬美元，而去年同期的非經常性收入為 150 萬美元。

Turning to gross margins, product margins were negative $0.6 million in Q4 compared to negative $2.4 million in the fourth quarter last year. The improvement was attributable to higher product revenue, higher production volumes in both systems and consumables and benefits from actions taken by the company to lower product costs and increased manufacturing efficiency, including enhancements made to our automated consumables manufacturing line earlier in the year.

談到毛利率，第四季的產品利潤率為負 60 萬美元，而去年第四季的產品利潤率為負 240 萬美元。這項改善歸因於產品收入的增加、系統和耗材產量的增加以及公司為降低產品成本和提高製造效率而採取的行動所帶來的好處，包括今年早些時候對我們的自動化耗材生產線進行的改進。

Service margins were positive at approximately $0.4 million in Q4 compared to negative $0.2 million last year. Higher revenues and increasing productivity drove the improvement in service margins in the quarter. On a combined basis, our fourth quarter gross margin was near breakeven at negative $0.2 million or negative 3% of revenues, representing a 24 percentage point improvement on a sequential basis and a 56 percentage point improvement compared to the fourth quarter last year.

第四季服務利潤率為正，約 40 萬美元，而去年為負 20 萬美元。收入的增加和生產力的提高推動了本季服務利潤率的提高。綜合來看，我們第四季的毛利率接近損益平衡，為負20 萬美元，即營收的負3%，比上一季提高了24 個百分點，與去年第四季相比提高了56 個百分點。

Looking at this margin improvement another way, our total revenue increased 45% in the fourth quarter, while our total cost of revenue decreased 7% over the same period, driving a significant improvement. Looking forward, we expect continued margin improvement in 2024 and beyond as we continue to grow revenues reduce product costs, drive higher manufacturing efficiency control, manufacturing overhead costs, and increased service productivity.

從另一個角度來看利潤率的提高，第四季我們的總收入成長了 45%，而同期總收入成本下降了 7%，推動了顯著的改善。展望未來，隨著我們繼續增加收入、降低產品成本、推動更高的製造效率控制、製造管理費用和提高服務生產力，我們預計 2024 年及以後的利潤率將持續改善。

Continuing down the P&L, total operating expenses were $12.0 million in the fourth quarter, consisting of $3.2 million in sales and marketing, $3.3 million in R&D, and $5.5 million in G&A. This compares to total operating expenses of $14.7 million in the fourth quarter of 2022. The decrease was largely due to nonrecurring costs incurred in the fourth quarter last year associated with the strategic review process initiated by our Board of Directors in that period as well as cost savings in Q4 of this year, resulting from the restructuring plan implemented in August 2022.

繼續以損益表計算，第四季總營運費用為 1,200 萬美元，其中銷售和行銷費用為 320 萬美元，研發費用為 330 萬美元，一般管理費用為 550 萬美元。相比之下，2022 年第四季的總營運費用為 1,470 萬美元。減少的主要原因是去年第四季度與董事會同期啟動的戰略審查流程相關的非經常性成本，以及2022年8月實施的重組計劃導致今年第四季度的成本節省。 。

Net loss was $11.2 million in Q4. This compares to a net loss of $16.4 million in Q4 last year. This improvement was largely due to higher revenue, better gross margins, and lower operating expenses, showing the broad financial benefits of the progress we made against several of our strategic focus areas in 2023.

第四季淨虧損為 1,120 萬美元。相比之下，去年第四季淨虧損 1,640 萬美元。這項改善主要歸功於更高的收入、更好的毛利率和更低的營運費用，這顯示了我們在 2023 年在幾個策略重點領域取得的進展所帶來的廣泛財務效益。

Net loss per share was $0.26 in Q4 compared to net loss per share of $0.39 in the prior year quarter. With respect to noncash expenses and capital expenditures, depreciation and amortization was $0.8 million. Stock compensation expense was $1.0 million and capital expenditures were $0.4 million in the fourth quarter.

第四季每股淨虧損為 0.26 美元，去年同期每股淨虧損為 0.39 美元。在非現金支出和資本支出方面，折舊和攤提為 80 萬美元。第四季股票補償費用為 100 萬美元，資本支出為 40 萬美元。

I'll now turn to our 2024 outlook where my comments will primarily be focused on the full year given current market conditions, our outlook reflects some uncertainty related to customer budgets and the timing and scale of customer purchase decisions.

我現在將轉向我們的 2024 年展望，鑑於當前的市場狀況，我的評論將主要集中於全年，我們的展望反映了與客戶預算以及客戶購買決策的時間和規模相關的一些不確定性。

With that context, we expect total revenue to be at least $27 million for the full year 2024, which assumes we will place at least 20 systems. This implies year-over-year revenue growth of at least 20%. Assuming typical seasonality with revenue and placements stepping down from Q4 to Q1 on a sequential basis, we expect total revenue of at least $5.5 million in Q1, which assumes at least three system placements. We then expect revenue placements in Q2 and Q3 to be higher than Q1 and then peak in Q4. While we anticipate launching Growth Direct rapid sterility by midyear, our guidance assumes any contribution from this new offering will be modest in 2024. Given our typical system sales cycle.

在此背景下，我們預計 2024 年全年的總收入至少​​為 2,700 萬美元，假設我們將部署至少 20 個系統。這意味著收入同比增長至少 20%。假設典型的季節性，收入和佈局從第四季度連續下降到第一季度，我們預計第一季的總收入至少​​為 550 萬美元，其中假設至少有三個系統佈局。我們預計第二季和第三季的營收將高於第一季度，然後在第四季達到高峰。雖然我們預計在年中推出 Growth Direct 快速無菌技術，但我們的指導假設這項新產品在 2024 年的貢獻將不大。鑑於我們典型的系統銷售週期。

Looking at consumables, we expect revenue to increase sequentially in Q1 compared to Q4 and then continue to increase sequentially each quarter over the balance of the year as more systems complete validation and ramp toward routine use. With respect to service, we expect revenues to be between $2.0 million and $2.5 million each quarter with variability primarily driven by the timing of validation activities, we expect to complete at least 16 validations in 2024 with at least three in the first quarter.

就消耗品而言，我們預計第一季的營收將比第四季連續成長，然後隨著更多系統完成驗證並逐步投入常規使用，在今年餘下的時間裡每季營收將繼續連續成長。在服務方面，我們預計每季的收入將在200 萬美元至250 萬美元之間，其變化主要由驗證活動的時間決定，我們預計在2024 年完成至少16 項驗證，其中第一季至少完成3項。

Turning to gross margins, we expect Q1 margins to be lower than Q4 due to the seasonality impact I mentioned earlier. Thereafter, based on our revenue outlook, the benefits from ongoing cost reduction and manufacturing efficiency initiatives and products and increasing productivity and service, we expect our gross margin percentage to improve, but still be negative in Q2 and then be single-digit positive in Q3 and Q4 as well as for the full year.

談到毛利率，由於我之前提到的季節性影響，我們預計第一季的利潤率將低於第四季。此後，根據我們的收入前景、持續降低成本和製造效率計劃和產品以及提高生產率和服務所帶來的好處，我們預計我們的毛利率將有所改善，但在第二季度仍為負值，然後在第三季為個位數正值和第四季以及全年。

We expect service margins to be positive in all four quarters and for product margins to improve each quarter as the year progresses. We expect operating expenses to be in a range of $48 million to $52 million in 2024, with depreciation and amortization of approximately $3 million, stock compensation of approximately $4.5 million, CapEx of approximately $3 million, and other income, which is comprised primarily of interest income, of approximately $3 million in 2024.

我們預計所有四個季度的服務利潤率都將為正，並且隨著時間的推移，產品利潤率每季都會提高。我們預計 2024 年營運費用將在 4,800 萬至 5,200 萬美元之間，其中折舊和攤提約為 300 萬美元，股票補償約為 450 萬美元，資本支出約為 300 萬美元，其他收入主要由利息組成2024 年收入約300 萬美元。

Finally, we expect cash burn of roughly $40 million in 2024, providing cash runway at least into the second half of 2026. This assumes a meaningful benefit from net working capital, including inventory reductions. That concludes my comments. So at this point we'll open the call up for questions. Operator?

最後，我們預計 2024 年現金消耗約為 4,000 萬美元，至少為 2026 年下半年提供現金跑道。這假設淨營運資本能帶來有意義的收益，包括庫存減少。我的評論到此結束。因此，此時我們將開始提問。操作員？

(Operator Instructions) Dan Arias, Stifel.

（操作員說明）Dan Arias，Stifel。

Good morning, guys. Thanks for the questions here. Sean, maybe just to start on the gross margin improvement, how much of what would get you crossed over into positivity this year is so to speak in the bank, all the efficiency improvements that you made last year, the cost work that you did versus things that have yet to be done or that depend on volumes for the year.

早上好傢伙。感謝您在這裡提出的問題。肖恩，也許只是從毛利率的改善開始，可以說，今年讓你變得積極的因素有多少是在銀行，你去年所做的所有效率改進，你所做的成本工作與尚未完成或取決於當年數量的事。

And just as a follow-up to that, I think you said down first half of the year and then single digits on up in the back half of the year. Does that get you up for the 1st year? And if you made that comment, I apologize. But just my rough glance at the model doesn't necessarily suggest that that could be the case?

作為後續行動，我認為您說過上半年出現下降，然後下半年出現個位數成長。這能讓你在第一年起床嗎？如果你發表了這樣的評論，我深感抱歉。但僅僅我粗略地看了一下模型並不一定表明情況可能是這樣？

Yes, start. I'll start with your second question, Dan. So yes, the guidance is margins. We think margins will be a little bit lower in Q1 compared to Q4. It get better, but still be negative in Q2, but then flip positive in Q3 and Q4. And for the full year, we expect it to be positive. So hopefully, that cadence makes sense their volume as a player in that. But there's a lot of other things at play within that cadence as well.

是的，開始吧。我將從你的第二個問題開始，丹。所以是的，指導就是利潤率。我們認為第一季的利潤率將略低於第四季。情況有所好轉，但第二季仍為負值，但隨後在第三季和第四季轉為正值。對於全年來說，我們預計它會是積極的。因此，希望這種節奏能讓他們作為一名球員發揮作用。但在這個節奏中還有很多其他的事情在起作用。

So I think that kind of segues to your first question. So I think we view there are some things like the automation improvements we made that are baked in. Your volume is important and then we there's ongoing work going on around the other things that we talked about, service productivity, cost down in products, other things we're doing around efficiency and the increased throughput in terms of manufacturing. So it's a mix, but there definitely are some components of that are things that we've now got baked in that are going to help support better performance on margins and move us positive in 2024.

所以我認為這就是你的第一個問題。所以我認為我們認為有一些東西，像是我們所做的自動化改進，是已經融入其中的。你的數量很重要，然後我們正在圍繞我們談論的其他事情進行持續的工作，服務生產力，產品成本降低，我們正在做的圍繞效率和提高製造吞吐量的其他事情。所以這是一個混合體，但我們現在已經融入了其中的一些組成部分，這些組成部分將有助於支持更好的利潤率表現，並讓我們在 2024 年取得積極的進展。

Okay, helpful. And then maybe just on the revenue side, annualized pull-through per systems, two questions there. Obviously, the new systems that are getting installed, alter the calculation a bit. But if you looked at sort of same-store sales, what you had installed at the end of last year, are you confident that the average pull-through level will be up this year.

好的，有幫助。然後也許只是在收入方面，每個系統的年化拉動率，有兩個問題。顯然，正在安裝的新系統稍微改變了計算。但是，如果您查看同店銷售情況，即去年年底安裝的產品，您是否有信心今年的平均拉動水平會上升。

And then on the consumables growth rate that we should be thinking here, 23% recurring revenue growth in 2023, how doable is a number like that this year, obviously you're growing the installed base. So that should help.

然後關於我們應該在這裡考慮的消耗品成長率，2023 年經常性收入成長 23%，今年這樣的數字有多可行，顯然你正在增加安裝基礎。所以這應該有幫助。

I think I think the implied growth rate on recurring is going to be a little bit lower, and I'll talk about that a little bit. I mean if we focus on Q4 performance first, we guided that we would be down sequentially mainly due to timing of shipments. And that's what we saw. And I think we it consumables, we are right, we have new systems coming online. The number we track, as we've talked about in the past is validated systems. And really we still have a little bit of work to do typically once we get there to get people in routine use. So we've got to manage that.

我認為經常性的隱含成長率會稍微低一些，我會稍微討論一下。我的意思是，如果我們首先關注第四季度的業績，我們預計我們的業績將連續下降，主要是由於發貨時間。這就是我們所看到的。我認為我們是消耗品，我們是對的，我們有新系統上線。正如我們過去所討論的，我們追蹤的數字是經過驗證的系統。事實上，一旦我們到達那裡，我們仍然有一些工作要做，以讓人們進行日常使用。所以我們必須解決這個問題。

Well, I think there's another important factor here, which we view as transient, but it's important to understand kind of where we're going to be because I'd say maybe to answer one of your questions there, I would look at this year as being in terms of pull through per average validated system. Our consumables revenue per average validated system being relatively flat with last year. And it's really there's one primary factor that's driving that. We had a is one of our most significant customers let us and you know, in mid 23 that they were actually selling a site that had multiple high-volume systems in it. So as we made our way through the second half of 23, we started to feel the impact of that as those systems came line, that is a contributor to what we're seeing in most recent quarters, and that is still the case today.

嗯，我認為這裡還有另一個重要因素，我們認為這是暫時的，但了解我們將走向何方很重要，因為我想說也許要回答你的一個問題，我會看看今年就每個經過驗證的系統的平均拉力而言。我們每個經過驗證的系統的平均耗材收入與去年持平。確實有一個主要因素推動了這一趨勢。我們最重要的客戶之一告訴我們，您知道，在 23 年中旬，他們實際上正在銷售一個包含多個高容量系統的網站。因此，當我們度過 23 月下半年時，我們開始感受到這些系統的上線所帶來的影響，這是我們在最近幾季所看到的情況的一個貢獻者，而且今天仍然如此。

Now the good news for us. And I think a reason for optimism and something we view as upside as the new owner of that site is communicating that they do plan to bring some of those systems, not all of them, but some of them back online later in 2024. So that actually having some of the some of our highest volume systems in the world go from kind of full pull through to offline. It is something that's important to think about as you think about the guidance that I just talked about.

現在對我們來說是個好消息。我認為樂觀的一個原因是，我們認為網站的新所有者有一個積極的一面，即他們確實計劃在 2024 年晚些時候將其中一些系統（不是全部）重新上線。因此，實際上我們世界上一些容量最大的系統從完全拉通變成離線。當你思考我剛才談到的指導時，這是一個需要思考的重要問題。

Okay. Maybe just last quick one since it feels like my time here, just on the validation timelines, do you think as an average 2024 validation timelines will be shorter than they were in 2023? Thanks.

好的。也許只是最後一個快速的，因為感覺就像我在這裡的時間，只是在驗證時間表上，您認為 2024 年的平均驗證時間表會比 2023 年短嗎？謝謝。

Yes, I think we've talked about project RAPID in the past and the work we're doing to shorten that process up. But we saw good progress on that in 23. And I would expect we'll see incremental progress on that in 24. So yes.

是的，我想我們過去已經討論過 RAPID 專案以及我們正在為縮短該流程所做的工作。但我們在 23 年看到了這方面的良好進展。我預計我們將在 24 年內看到這方面的逐步進展。所以是的。

Tejas Savant, Morgan Stanley.

Tejas Savant，摩根士丹利。

Hi, this is Jason on for Tejas. Congratulations on the quarter and thank you for taking my questions. So just some questions related to sterility. Could you elaborate on the competitive landscape of Pirelli versus other competitors in the space? And with the launch, do you anticipate the new offering opening up opportunities with new customers or expanding placements with existing customers.

大家好，我是 Tejas 的 Jason。恭喜本季度，感謝您回答我的問題。所以只是一些與不孕症相關的問題。能否詳細介紹倍耐力與該領域其他競爭對手的競爭格局？隨著產品的推出，您是否預期新產品將為新客戶帶來機會，或擴大現有客戶的展示位置。

And I guess on a related note, do you anticipate that you'll be building out a sales force to support us through early sales? Or would you leverage your existing sales force? Thank you.

我想在相關的說明中，您是否預計您將建立一支銷售團隊來支持我們透過早期銷售？或是您會利用現有的銷售團隊嗎？謝謝。

Thanks for the question. It's Rob. So I think it was three in there. The first one is the competitive landscape of. So as with our other applications, the the top the top competitor is the legacy method and sterility is that being said, there is what I what I would call on increased competitive activity from other suppliers of rapid sterility applications in the market versus our other applications. So it is a it is a market where there are some incumbents offering, I'll call it technology enabled on rapid solutions. That being said, we knew that coming into this market and we specifically developed and designed the system to offer a compelling differentiation clearly against the legacy and traditional method but also against the current, I'll call it technology-enabled message and we like how we compare against the, I'll call it, the other offerings in the market as I mentioned in my prepared remarks.

謝謝你的提問。是羅布。所以我認為裡面有三個。第一個是競爭格局。因此，與我們的其他應用程式一樣，最大的競爭對手是傳統方法，而無菌性是指，與我們的其他應用程式相比，我所說的市場上其他快速無菌應用程式供應商的競爭活動增加。因此，這是一個有一些現有企業提供產品的市場，我將其稱為基於快速解決方案的技術。話雖這麼說，我們知道進入這個市場，我們專門開發和設計了該系統，以提供與傳統方法和當前方法明顯不同的引人注目的差異化，我將其稱為技術支援的消息，我們喜歡如何正如我在準備好的發言中提到的，我們將其與市場上的其他產品進行比較。

The second question with regard to new and existing customers, I think the answer is both. I think the exciting thing about sterility is that customers are excited about it first and foremost in our existing customer base. So the majority of our current customers are small molecules. I mean, I'm sorry, large molecules to include biologics and cell and gene, but really will also get us more deeply into small molecule injectable manufacturing as well. So to expand, expand effectively on our our our opportunity and a lot of ways and move our sales team more squarely into into those segments.

第二個問題是關於新客戶和現有客戶，我認為答案是兩者兼具。我認為關於無菌的令人興奮的事情是，客戶首先對我們現有的客戶群感到興奮。所以我們目前的客戶大部分都是小分子。我的意思是，對不起，大分子包括生物製劑、細胞和基因，但實際上也將使我們更深入地進入小分子注射劑製造。因此，要擴大、有效地擴大我們的機會和多種方式，並使我們的銷售團隊更直接進入這些細分市場。

And also with regard to sales team specifically, we primarily are planning on leveraging our current our sales team, which we now have up and running in all three regions. That being said, we will have a dedicated sterility, I'll call a group of TBD on the actual head count in that, but the specialists focused on on assisting in enabling our sales team with some of the technical elements and application elements of the three really specific activities.

特別是在銷售團隊方面，我們主要計劃利用我們現有的銷售團隊，我們現在在所有三個地區都建立並經營該團隊。話雖這麼說，我們將有一個專門的無菌團隊，我將根據實際人數召集一個待定小組，但專家們專注於協助我們的銷售團隊掌握一些技術要素和應用要素三項真正具體的活動。

That's helpful. And then if I could squeeze in a question. And so with the reality development nears final stages, what are the next areas of product or workflow development that could it enhance the customer experience on first direct? Thank you.

這很有幫助。然後我能否插話問一個問題。因此，隨著現實開發接近最後階段，產品或工作流程開發的下一個領域是什麼，可以增強首次直接的客戶體驗？謝謝。

Yes. So on from a high level, we view the growth direct as a platform technology. And generally, our product strategy is to continue to influence the workflow and around our platform technology. So we we automate the microbial quality control process. We detect contamination. We enumerate contamination, and we do that now with sterility being launched or to be launched midyear across the primary microbial quality control tests of environmental monitoring, water, bioburden and soon sterility on. We also envision over time going downstream and providing more information to customers with regard to the organisms that they're picking up and detecting in their in their workflows.

是的。因此，從較高的層面來看，我們將直接成長視為一種平台技術。一般來說，我們的產品策略是繼續影響工作流程和我們的平台技術。因此，我們將微生物品質控製過程自動化。我們檢測污染。我們列舉了污染情況，我們現在就開始這樣做，並在環境監測、水、生物負載等主要微生物品質控制測試中啟動或將在年中啟動無菌測試，並很快啟動無菌測試。我們還設想隨著時間的推移，向下游延伸，向客戶提供更多有關他們在工作流程中拾取和檢測的生物體的信息。

I think molds, the more technology we released last year is a really good example of that, and there could be extensions around that. And also data. We feel we're generating enormous amounts of our digital data for customers. And this is the first time that these labs have had access to this kind of data and how can we help customers use manage look into their data and looking at our operations, not only on a site basis. But on a global basis, our goal is to become the new quality control infrastructure. And as we grow our our site network globally, we are on We're basically creating a new microbial quality control infrastructure for our customers.

我認為模具，我們去年發布的更多技術就是一個很好的例子，並且可以圍繞它進行擴展。還有數據。我們認為我們正在為客戶產生大量數位數據。這是這些實驗室第一次存取此類數據，我們如何幫助客戶管理他們的數據並查看我們的運營，而不僅僅是在現場。但在全球範圍內，我們的目標是成為新的品質控制基礎設施。隨著我們在全球範圍內發展我們的站點網絡，我們基本上正在為我們的客戶創建一個新的微生物品質控制基礎設施。

And with that, what kind of services and insights can we provide just given the enormous amount of data that we're we're generating and now this is a commitment or guidance per se, but it gives you a little bit of insight into how we're thinking about expanding our influence up and down the the quality control workflow with our customers, our manufacturing and quality operations.

有了這個，鑑於我們正在產生的大量數據，我們可以提供什麼樣的服務和見解，現在這本身就是一種承諾或指導，但它讓您了解如何我們正在考慮擴大我們對客戶、製造和品質運營的品質控制工作流程的影響力。

Steven Mah, TD Cowen.

史蒂文·馬，TD·考恩。

I'm great, thanks. And congrats on the quarter and thanks for taking the questions of my own. Yes, one on Samsung Biologics. I had them selecting their growth direct platform for their microbial TC. Can you remind us if it was a multi-system placement and was at multiple Samsung sites? And then if you could give us some color on the sense of the magnitude of that, you know, Samsung going forward, you noisy as you kind of expand across the Samsung, no global sites, you know, when can you expect more Samsung placements. Now, obviously, it's a pretty huge entity.

我很好謝謝。恭喜本季度，感謝您提出我自己的問題。是的，三星生物製品公司的一份子。我讓他們為微生物 TC 選擇生長直接平台。您能否提醒我們這是一個多系統放置並且位於多個三星站點？然後，如果您能給我們一些關於其重要性的信息，您知道，三星正在向前發展，當您在三星範圍內擴張時，您會很吵鬧，沒有全球站點，您知道，您什麼時候可以期待更多的三星展示位置。現在，顯然，它是一個相當龐大的實體。

Yes. So that's actually what we're really excited about. The Samsung partnership and the Company selecting us. Samsung as a great company, does their diligence and we think it speaks volumes. They selected the Growth Direct. We did place a multisystem order at a single site last year. And yes, I won't go into the forward looking on expectation, but I can tell you we're looking forward to your point's a large organization and we're very much looking forward to growing with Samsung in the coming quarters and the coming years.

是的。這實際上是我們真正感到興奮的事情。三星合作夥伴以及公司選擇我們。三星作為一家偉大的公司，盡職盡責，我們認為這很有意義。他們選擇了成長直接。去年我們確實在一個站點下了多系統訂單。是的，我不會對預期進行前瞻性討論，但我可以告訴您，我們期待您的觀點是一個大型組織，我們非常期待在未來幾個季度和未來的幾個季度與三星一起成長年。

Okay, great. I appreciate that. And then maybe a follow-up question here on the CRO landscape. Given the current geopolitical sentiment, the proposed bipartisan budget SECURE Act, could you give us a sense of your exposure arm two CROs that were kind of named in that biopsy Care Act?

好的，太好了。我很感激。然後可能是關於 CRO 前景的後續問題。考慮到當前的地緣政治情緒，擬議的兩黨預算安全法案，您能否讓我們了解一下您對兩家 CRO 的暴露情況，這兩家機構在活檢護理法案中有所提及？

Yes, it's very low. I think I think specifically around China. So our connectivity and exposures is it is quite low. We have a strong CDMO footprint. I think, as you know, our value prop resonates strongly there. But our current Onyx in our expected customer base would be independent of that bio SECURE Act and the named parties within.

是的，它非常低。我想我主要是圍繞中國思考的。所以我們的連通性和曝光度是相當低的。我們擁有強大的 CDMO 足跡。我認為，正如您所知，我們的價值主張在那裡引起了強烈的共鳴。但我們目前預期客戶群中的 Onyx 將獨立於《生物安全法案》和其中指定的各方。

Okay. Net for appreciate that color. And last one's a follow-up question on Rapid Sterility. Can you just walk through some of the positive early beta testing feedback and the stress testing that you did during that day and launch that that's driving confidence in the expected in a midyear launch and has Rapid Sterility helping drive conversation with new customers?

好的。淨欣賞那種顏色。最後一個是關於快速不孕症的後續問題。您能否簡單介紹一下您當天所做的一些積極的早期Beta 測試反饋和壓力測試，並發布這些測試，這會增強人們對年中發布的預期的信心，並且快速無菌是否有助於推動與新客戶的對話？

Yes. So in reverse order on we own, it is helping drive conversations with new customers and existing customers on. So we've been I wouldn't say surprise because we expected a positive response and we're getting it. I think it's important to note that there's we have not assumed a meaningful contribution for sterility in our 2024 guide, just given the mid-year launch and the sales cycle timing. But we're certainly going to preserve the opportunity to have upside with regard to sterility. And there is there is quite a bit of excitement around it. Our confidence comes from a combination of customer feedback as well as rigorous development process we have internally. So that process goes through the system readiness, the it's basically a new consumable that worked with the system and a lot of testing with regard to some of the data that you've seen published with regard to time to detection and time to result.

是的。因此，按照我們自己的相反順序，它正在幫助推動與新客戶和現有客戶的對話。因此，我不會說我們感到驚訝，因為我們預計會得到積極的回應，而且我們正在得到它。我認為值得注意的是，僅考慮到年中發布和銷售週期時間，我們在 2024 年指南中並沒有假設對不孕症做出有意義的貢獻。但我們肯定會保留在不孕方面獲得優勢的機會。圍繞它有很多令人興奮的事情。我們的信心來自客戶回饋以及我們內部嚴格的開發流程的結合。因此，這個過程經歷了系統準備就緒，它基本上是一種與系統配合使用的新消耗品，並對您所看到的一些已發布的有關檢測時間和結果時間的數據進行了大量測試。

And then, of course, that that data, we will work with customers to open overtime validate their environments, but were and where we are today, we're quite confident in what we're seeing and that gave us the confidence to it released a press release and all the above kind of feeds into that. Our internal data feedback from the market research we've done and our internally generated data all kind of collude together to give us that that outlook and confidence to move forward.

當然，我們將與客戶合作，加班加點地驗證他們的環境，但無論是過去還是現在，我們對所看到的數據都非常有信心，這讓我們有信心發布它新聞稿以及所有上述內容都將納入其中。我們從市場研究中獲得的內部數據回饋和內部產生的數據共同為我們提供了前進的前景和信心。

And and also inbound interest from customers also is feathering into the into the mix now too, which is which is very exciting. So more more to follow up. We'll look forward to update you as we go forward through the quarters here. But I can say just kind of in summary, we're excited about the product and so far, the market also seems quite excited about the product as well.

而且，來自客戶的入境興趣現在也正在融入其中，這是非常令人興奮的。所以還有更多後續。我們期待在接下來的幾季中向您通報最新情況。但我可以概括地說，我們對該產品感到興奮，到目前為止，市場似乎也對該產品感到非常興奮。

Well, thanks, Steve, for the question. And thanks, everyone for joining us today. Again, we enter year with strong momentum and a great position to deliver an excellent year in 2024. I will look forward to speaking with many of you over the next few weeks at the TD, Cowen and key and KeyBanc life sciences conferences. Thank you all.

好吧，謝謝史蒂夫提出這個問題。感謝大家今天加入我們。我們再次以強勁的勢頭進入新的一年，並有能力在 2024 年交付出色的一年。我期待在接下來的幾週內在 TD、Cowen 以及 key 和 KeyBanc 生命科學會議上與你們中的許多人交談。謝謝你們。

Ladies and gentlemen, this concludes today's conference call. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。您現在可以斷開連線。