Meridian Bioscience Inc (VIVO) 2022 Q2 法說會逐字稿

Greetings, and welcome to Meridian Bioscience Fiscal Second Quarter 2022 Earnings Call. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 Meridian Bioscience 2022 年第二季財報電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。

It is now my pleasure to introduce your host, Charlie Wood, Vice President of Investor Relations. Thank you. You may begin.

現在我很高興向您介紹主持人，投資者關係副總裁查理伍德。謝謝。你可以開始了。

Thank you, Operator. Good morning and welcome to Meridian's fiscal 2022 second quarter earnings call. With me are Jack Kenny, Chief Executive Officer, and Andy Kitzmiller, Chief Financial Officer.

謝謝你，接線生。早安，歡迎參加 Meridian 2022 財年第二季財報電話會議。與我在一起的有執行長傑克肯尼 (Jack Kenny) 和財務長安迪基茨米勒 (Andy Kitzmiller)。

Please note that our SEC filings, earnings release and slides to accompany this call are available on our website at investor.meridianbioscience.com. We will post a copy of these prepared remarks after the call.

請注意，我們的 SEC 文件、財報發布以及本次電話會議隨附的幻燈片可在我們的網站 Investor.meridianbioscience.com 上取得。我們將在電話會議後發布這些準備好的評論的副本。

With regards to our calendar, Jack, Andy and I are participating in the HC Wainwright Global Invest Conference on May 24th. Any additional conferences will be announced via press release and posted to our website as they're finalized. Lastly, our Q3 fiscal 2022 earnings call is scheduled for Friday, August 5th, 2022.

根據我們的日曆，傑克、安迪和我將參加 5 月 24 日舉行的 HC Wainwright 全球投資會議。任何其他會議將透過新聞稿宣布，並在最終確定後發佈到我們的網站上。最後，我們的 2022 財年第三季財報電話會議定於 2022 年 8 月 5 日星期五舉行。

Before we begin today, let me remind you that the presentation and the company's remarks include forward-looking statements. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the company's control, including risks and uncertainties described from time to time in the company's SEC filings. The company's results may differ materially from those projected. Meridian makes these statements as of today, May 6th, 2022 and undertakes no obligation to publicly update them.

在今天開始之前，讓我提醒您，簡報和公司的言論包含前瞻性陳述。前瞻性陳述受到許多風險和不確定性的影響，其中許多風險和不確定性超出了公司的控制範圍，包括公司向 SEC 提交的文件中不時描述的風險和不確定性。本公司的業績可能與預期有重大差異。 Meridian 截至今天（2022 年 5 月 6 日）做出這些聲明，並且不承擔公開更新這些聲明的義務。

Additionally, the company's remarks also include market data based on management's knowledge of the industry and good faith estimates of management. The market data reference involves a number of assumptions and limitations and you're cautioned not to give undue weight to such estimates. While we believe the estimated market position, market opportunity and market size information is generally reliable, such information, which in part is derived from management estimates and beliefs, is inherently uncertain and imprecise and has not been verified by any independent source.

此外，該公司的言論還包括基於管理層對行業的了解和管理層的善意估計的市場數據。市場數據參考涉及許多假設和限制，請注意不要過度重視此類估計。雖然我們認為估計的市場地位、市場機會和市場規模資訊總體上是可靠的，但這些資訊部分來自管理層的估計和信念，本質上是不確定和不精確的，並且未經任何獨立來源驗證。

Lastly, throughout this presentation, we refer to non-GAAP financial measures, specifically operating expenses, operating income, operating margin, net earnings, and net earnings per diluted share, each on an adjusted basis. A reconciliation of these non-GAAP financial measures with the most directly comparable GAAP measures and other related discussion are included in our earnings release.

最後，在本簡報中，我們提到了非公認會計原則財務指標，特別是營業費用、營業收入、營業利潤率、淨利潤和稀釋後每股淨利潤，均經過調整。這些非公認會計原則財務指標與最直接可比較的公認會計原則指標的調節以及其他相關討論均包含在我們的收益發布中。

And now I'd like to turn the call over to Jack.

現在我想把電話轉給傑克。

Thank you, Charlie. Q2 was a fantastic quarter for Meridian and another all-time record for revenue. What makes it even better is that both business units were firing on all cylinders, individually producing record quarterly revenue. Andy, who joined us in February, will go over the financial results in more detail later in the call.

謝謝你，查理。第二季度對 Meridian 來說是一個出色的季度，並創下了收入的新紀錄。更棒的是，兩個業務部門都在全力以赴，各自創造了創紀錄的季度收入。安迪於二月加入我們，他將在稍後的電話會議中更詳細地討論財務表現。

Overall, we saw a quarter with strong demand for COVID-19 products from both Life Science and Diagnostic segments due to the Omicron variant. However, outside of sales of the COVID-19 antigen test, Diagnostics also saw growth in other respiratory products and in our urea breath tests for H. pylori. As others have reported, we too saw demand for COVID-19 products subside in the last few weeks of the quarter, as one would expect as Omicron cases have decreased around the world, consistent with the typical end of a respiratory season. In parallel, we are seeing Laboratories and Diagnostics increase focus on their core business of non-COVID testing, which bodes well for a new normal in the endemic stage for the virus.

總體而言，由於 Omicron 變異體，我們看到生命科學和診斷領域對新冠肺炎 (COVID-19) 產品的需求強勁。然而，除了 COVID-19 抗原檢測的銷售之外，Diagnostics 的其他呼吸產品和幽門螺旋桿菌尿素呼氣檢測也出現了增長。正如其他人所報導的那樣，我們也看到本季最後幾週對COVID-19 產品的需求有所下降，正如人們所預期的那樣，因為世界各地的Omicron 病例有所減少，這與典型的呼吸道季節結束相一致。同時，我們看到實驗室和診斷部門更加關注其非新冠檢測核心業務，這預示著病毒流行階段的新常態。

In February, we completed the work necessary to bring LeadCare II assay back to the market 6 weeks ahead of schedule. The team is still working through a backlog of orders, but the good news is that demand is high with customers, and they're excited to be able to use our point-of-care lead test for their patients again.

2 月份，我們提前 6 週完成了將 LeadCare II 檢測重新推向市場所需的工作。團隊仍在處理積壓的訂單，但好消息是客戶的需求很高，他們很高興能夠再次為患者使用我們的護理點鉛測試。

In early March, we completed work on the Revogene SARS-CoV-2 assay and submitted our analysis to the FDA. As part of the dialogue with the FDA, they requested some additional data. We have provided some of the data and are in the process of conducting the additional studies necessary to complete their request. We expect to finish those studies in the next few weeks and are hopeful for an expedited review. Bringing this assay to market remains essential for the Revogene instrument as customers continue to wait for it to begin shipping before installing new instruments. The Revogene install base, as of the end of the quarter, was [375], up from [370] at the end of Q1.

3 月初，我們完成了 Revogene SARS-CoV-2 檢測工作，並向 FDA 提交了我們的分析結果。作為與 FDA 對話的一部分，他們要求提供一些額外的數據。我們已經提供了一些數據，並且正在進行必要的額外研究來完成他們的請求。我們預計在接下來的幾週內完成這些研究，並希望能夠加快審查。將這種檢測方法推向市場對於 Revogene 儀器來說仍然至關重要，因為客戶在安裝新儀器之前仍然需要等待它開始出貨。截至本季末，Revogene 安裝基數為 [375]，高於第一季末的 [370]。

As I mentioned in our last earnings call, our new Revogene manufacturing line in Cincinnati completed validation of the first line and began producing Group A strep kits. We've already noticed a positive impact from the automated manufacturing in Cincinnati, as it requires fewer staff to produce the same number of kits per [chip] than at our Quebec facility. The upcoming second manufacturing line in Cincinnati will have even greater production efficiency and capacity, and is expected to be online later this year.

正如我在上次財報電話會議中提到的，我們位於辛辛那提的新 Revogene 生產線完成了第一條生產線的驗證，並開始生產 A 型鏈球菌試劑盒。我們已經注意到辛辛那提自動化製造的積極影響，因為與我們魁北克工廠相比，生產每個[晶片]相同數量的套件所需的員工更少。即將在辛辛那提建設的第二條生產線將具有更高的生產效率和產能，預計今年稍後上線。

Also in the quarter, the Cincinnati team will begin -- began validation of the second Revogene assay, C. diff. We expect to complete the validation and begin producing those kits in our new manufacturing facility by the end of the quarter.

同樣在本季度，辛辛那提團隊將開始驗證第二個 Revogene 檢測 C. diff。我們預計將在本季末完成驗證並開始在我們的新製造工廠生產這些套件。

With regards to new product development, you will notice in our slides, some changes to the FDA submission and expectations for the fiscal year. All the assays we plan to submit this year were expected late in the fiscal year. With recent delays in starting clinical trials for the Revogene gastrointestinal panel and [Kurian] C. diff, it is clear that we will not be able to submit those this fiscal year. Additionally, there was another limited flu season in which impacted the timing of the clinicals for the Revogene respiratory panel and delayed it into the next respiratory season. That said, Kurian Shiga toxin is currently in clinicals and is still on track for submission late in September.

關於新產品開發，您會在我們的幻燈片中註意到 FDA 提交文件和本財年預期的一些變化。我們計劃今年提交的所有檢測預計將在本財政年度結束時提交。由於近期 Revogene 胃腸道組合和 [Kurian] C. diff 臨床試驗的開始延遲，很明顯，我們將無法在本財年提交這些試驗。此外，還有一個有限的流感季節，影響了 Revogene 呼吸系統面板的臨床時間，並將其推遲到下一個呼吸季節。也就是說，Kurian Shiga 毒素目前正處於臨床階段，並預計在 9 月底提交。

New to the chart, in February, we submitted a new claim to the FDA for our urea breath test on the breath ID platform. The current package insert states that the test may not be performed if the patient has been taking proton pump inhibitors or PPIs within the last 2 weeks. The new requested labeling modification informs clinicians that they may act upon a positive test result in patients that were using PPIs within 2 weeks of the breath test. In the event of a negative test result, the test will need to be repeated after 2 weeks of discontinuing use of PPIs. We believe this new claim will improve marketability and patient usage of the product. The FDA has indicated it could take up to 9 months to review our submission and we will provide more details after receiving feedback from the FDA. Congratulations to our team in Israel for getting that work completed.

今年 2 月，我們向 FDA 提交了一份新的聲明，要求我們在呼吸 ID 平台上進行尿素呼氣測試。目前的包裝說明書規定，如果患者在過去 2 週內一直服用質子幫浦抑制劑或 PPI，則可能不會進行該測試。新要求的標籤修改告知臨床醫生，他們可以根據呼氣測試兩週內使用 PPI 的患者的陽性測試結果採取行動。如果檢測結果為陰性，則需要在停止使用 PPI 兩週後重新進行檢測。我們相信這項新聲明將提高該產品的適銷性和患者使用率。 FDA 表示可能需要長達 9 個月的時間來審查我們提交的資料，我們將在收到 FDA 的回饋後提供更多詳細資訊。祝賀我們在以色列的團隊完成了這項工作。

Turning to Life Science, earlier this week, we announced the acquisition of EUPROTEIN, a company in New Jersey that specializes in the design and manufacture of recombinant proteins. They have quickly integrated into our R&D team and will help us accelerate our pipeline of new immunoassay reagents. We are excited to welcome EUPROTEIN into the Meridian family, and we'll share more about what they're working on in the coming quarters. Additionally, we expanded the sample-specific Master Mixes portfolio with the launch of the Lyo-Ready blood-specific Master Mixes and launched a new detergent-free [toxo] antigen ideal for large lab-based immunoassay systems.

談到生命科學，本週早些時候，我們宣布收購 EUPROTEIN，這是一家位於新澤西州的公司，專門從事重組蛋白的設計和製造。他們已迅速融入我們的研發團隊，將協助我們加速新型免疫檢測試劑的研發進程。我們很高興歡迎 EUPROTEIN 加入 Meridian 家族，我們將在未來幾季分享更多有關他們正在進行的工作的資訊。此外，我們也推出了 Lyo-Ready 血液特異性預混液，擴大了樣本特異性預混液產品組合，並推出了一種新型無去垢劑 [toxo] 抗原，非常適合大型實驗室免疫分析系統。

Continuing with the format I introduced last quarter, I would like to take a few minutes to dive deeper into our Life Science business in an effort to highlight the opportunity ahead of us. As a reminder, when I joined Meridian, there were 2 business units that made up what today -- what today is known as our Life Science segment and each was run separately with different strategies. The immuno business had decades of experience selling to the largest diagnostic companies in the world, whereas the molecular business was mainly focused on research and academia. We merged these 2 segments into one and at the end of fiscal 2018, we decided to pivot the molecular business to focus on large diagnostic companies. That essentially required an overhaul of the sales team as well as creation of an entirely new molecular product line designed for the needs of global diagnostic companies. Those strategic shifts were timed perfectly, and the company was well positioned at the beginning of 2020 to meet the unprecedented testing demands of a global pandemic.

繼續我上季度介紹的格式，我想花幾分鐘時間更深入地了解我們的生命科學業務，以強調我們面前的機會。提醒一下，當我加入 Meridian 時，有 2 個業務部門組成了今天的生命科學部門，每個部門都採用不同的策略單獨運作。免疫業務擁有數十年向世界上最大的診斷公司銷售產品的經驗，而分子業務主要集中在研究和學術界。我們將這兩個部分合併為一個，並在 2018 財年末，我們決定將分子業務重點轉向大型診斷公司。這本質上需要對銷售團隊進行徹底改革，並創建一個全新的分子產品線，以滿足全球診斷公司的需求。這些策略轉變的時機恰到好處，該公司在 2020 年初已做好充分準備，可以滿足全球大流行帶來的前所未有的測試需求。

The pandemic accelerated the need to develop assays quickly, measured in weeks and not months. R&D scientists turned to our readymade qPCR Master Mixes to accelerate their development timelines. Meridian's Master Mixes became extremely popular due to their performance and our ability to quickly supply the large quantities that were required. As the pandemic unfolded, there were shortages of RNA extraction kits necessary to process patient samples. In response, our team developed the first commercially available inhibitor tolerant mix that did not require RNA extraction. That means you can take the patient sample direct to the assay without further extraction steps.

這場大流行加速了快速開發檢測方法的需求，以幾週而不是幾個月的時間來衡量。研發科學家轉向我們現成的 qPCR Master Mix 來加快他們的開發進度。 Meridian 的 Master Mix 因其卓越的性能以及我們快速供應大量所需的能力而變得非常受歡迎。隨著疫情的蔓延，處理病患樣本所需的 RNA 萃取試劑盒出現短缺。作為回應，我們的團隊開發了第一個市售的抑制劑耐受混合物，不需要提取 RNA。這意味著您可以將患者樣本直接進行檢測，無需進一步的提取步驟。

It was this experience that has shaped our unique strategy to support the Diagnostics industry. We view ourselves as a partner to R&D teams around the world with the goal of supplying them the best performing Master Mixes optimized for their specific need in order to accelerate the development of world class assays. We became extremely focused on disrupting the way assays are developed and creating a series -- and created a series of Master Mixes engineered to address inhibitors in the various types of patient samples.

正是這種經驗塑造了我們支持診斷產業的獨特策略。我們將自己視為世界各地研發團隊的合作夥伴，目標是為他們提供針對其特定需求而優化的最佳性能預混液，以加速世界級檢測的開發。我們非常專注於破壞檢測方法的開發方式並創建一系列的方法，並創建了一系列旨在解決各種類型患者樣本中的抑制劑的預混液。

We developed ultrasensitive Master Mixes that R&D departments do not need to optimize, and come in formats for a variety of devices. Our R&D team focused on addressing the most clinically relevant patient samples, such as saliva, sputum, blood serum, plasma, urine, and stool.

我們開發了研發部門無需優化的超靈敏預混液，並且具有適用於各種設備的格式。我們的研發團隊專注於處理與臨床最相關的患者樣本，例如唾液、痰、血清、血漿、尿液和糞便。

In addition, we also developed Master Mixes to target the ag bio and food market where the sample is plant or food material. Leveraging our proprietary buffer systems and expertise in using excipients to suppress inhibitors, we set out to create series of Master Mixes optimized for each of these sample types. We currently have the only portfolio of sample-specific Master Mixes on the market. And by the end of this fiscal year, we will have built out the portfolio to include mixes for all key sample types, across both qPCR and LAMP chemistries.

此外，我們也針對樣品為植物或食品材料的農業生物和食品市場開發了預混料。利用我們專有的緩衝系統和使用賦形劑抑制抑制劑的專業知識，我們著手創建針對每種樣品類型優化的系列預混液。目前，我們擁有市場上唯一的特定於樣品的預混音組合。在本財政年度結束時，我們將建立產品組合，包括 qPCR 和 LAMP 化學中所有關鍵樣本類型的混合物。

We're disrupting molecular assay development by offering Master Mixes that do not require any optimization. All you have to do is add your primers and probes, and you have a final assay with direct from sample detection and the flexibility of a wet, lyophilized or air-dried format. This is disruptive in the sense that you can develop assays very quickly and save time on optimizing and troubleshooting due to difficult sample types that can decrease the sensitivity of an assay.

我們透過提供不需要任何優化的預混液來破壞分子測定的發展。您所要做的就是添加引子和探針，然後您就可以直接透過樣品檢測以及濕式、冷凍乾燥式或風乾式的靈活性進行最終測定。從某種意義上說，這是顛覆性的，您可以非常快速地開發檢測，並節省優化和故障排除的時間，因為困難的樣本類型可能會降低檢測的靈敏度。

This is a unique approach within the industry and is resonating well with our customers. We have almost 200 customers using these novel mixes year to date, and what is really exciting is the diversity of what they're sampling. Our blood mixes have been the most popular, followed by saliva, stool, urine and plant. Not only does this bode well for our approach, but is also a clear signal that the focus has shifted away from building COVID assays and back to all other diseases that impact the global population year in and year out.

這是業內獨特的方法，並與我們的客戶產生了良好的共鳴。今年迄今為止，我們有近 200 名客戶在使用這些新穎的混合物，真正令人興奮的是他們所採樣的產品的多樣性。我們的血液混合物最受歡迎，其次是唾液、糞便、尿液和植物。這不僅對我們的方法來說是個好兆頭，而且也是一個明確的信號，表明重點已經從建立新冠檢測方法轉向年復一年影響全球人口的所有其他疾病。

Lastly, I would like to touch on format types as this is another area where we differentiate. Assays can be delivered in either a wet format or a dry format. The advantage of dried-down assays is that they are stable at room temperature, removing the need for cold chain shipping and storage. Not only does this lower the cost of shipping and storage for our customers and their customers, but it is also more environmentally friendly, reducing the use of electricity and Styrofoam. We have developed versions of each of our mixes to work in either a wet or dry format to meet the needs of our customers.

最後，我想談談格式類型，因為這是我們區分的另一個領域。檢測可以以濕法或乾法進行。乾燥測定的優點是它們在室溫下穩定，無需冷鏈運輸和儲存。這不僅降低了我們的客戶及其客戶的運輸和儲存成本，而且更加環保，減少了電力和聚苯乙烯泡沫塑膠的使用。我們開發了每種混合物的版本，可以以濕式或乾式形式工作，以滿足客戶的需求。

Historically, the only way to dry an assay was through a process called lyophilization. Lyophilization requires capital investment and expensive equipment or multiple days to send the kits to a third party with the right capabilities. This can add upwards of $1 to $3 to the production of a single test. In 2020, we introduced an air-dryable formulation that enables drying using inexpensive commercial ovens. We believe Meridian is the only company in the world that has commercialized air-dryable master mixes for qPCR and LAMP.

從歷史上看，乾燥測定的唯一方法是透過稱為凍乾的過程。凍乾需要資本投資和昂貴的設備，或需要幾天時間才能將試劑盒發送給具有適當能力的第三方。這可能會導致單次測試的成本增加 1 至 3 美元。 2020 年，我們推出了一種可風乾的配方，可以使用廉價的商用烤箱進行乾燥。我們相信 Meridian 是世界上唯一一家將用於 qPCR 和 LAMP 的可風幹預混液商業化的公司。

As you can see, our Life Science teams' approach is disrupting traditional approaches to assay development. Not only do these innovations benefit our customers financially, but they enable the development of the highest quality assays to improve patient care, with the added benefit of reducing the environmental impact of diagnostic testing. In addition to developing products that help our customers be more environmentally friendly, Meridian is also dedicated to 2 important goals. First, advancing Diagnostics to better -- to enable better patient outcomes and in sum, helping people. And second, ensuring that our culture is inclusive, diverse, and equitable.

正如您所看到的，我們生命科學團隊的方法正在顛覆傳統的檢測開發方法。這些創新不僅使我們的客戶在經濟上受益，而且能夠開發出最高品質的檢測方法，以改善患者護理，並具有減少診斷測試對環境影響的額外好處。除了開發幫助客戶變得更環保的產品外，Meridian 還致力於實現兩個重要目標。首先，更好地推進診斷——以實現更好的患者治療結果，總之，幫助人們。其次，確保我們的文化具有包容性、多元性和公平性。

Those words carry great meaning at Meridian, and we've been intentional and thoughtful about listing them in that order as we believe that you first have to be inclusive to attract and retain a diverse team. We're in the early stages of our ESG journey, excited about the prospects and look forward to sharing more with you as we achieve meaningful progress.

這些字詞在 Meridian 具有重大意義，我們有意且深思熟慮地按順序列出它們，因為我們相信，首先必須具有包容性才能吸引和留住一支多元化的團隊。我們正處於 ESG 之旅的早期階段，對前景感到興奮，並期待在我們取得有意義的進展時與您分享更多資訊。

And now it's my pleasure to introduce you to our new CFO, Andy, to provide more details on the financial results for the quarter.

現在，我很高興向您介紹我們的新財務長安迪，他將提供有關本季財務業績的更多詳細資訊。

Hello everyone. It's great to be speaking with you today. I've had a chance to meet a few of you and I look forward to meeting more of you at conferences in the coming months. As Jack mentioned, this was a great quarter, not only for Meridian in total, but also for each of the operating segments. Consolidated net revenues were $111 million, up 30% year-over-year, and a new quarterly high for the company. Diagnostics segment net revenues grew 29% to $41 million, also a record for the segment. Growth was driven by urea breath testing for H. pylori and the respiratory category. In particular, respiratory included a significant contribution from the GenBody COVID-19 antigen test.

大家好。很高興今天能和你說話。我有機會見到了你們中的一些人，我期待在未來幾個月的會議上見到更多的人。正如傑克所提到的，這是一個偉大的季度，不僅對 Meridian 整體而言，而且對每個營運部門也是如此。合併淨收入為 1.11 億美元，年增 30%，創公司季度新高。診斷部門的淨收入成長了 29%，達到 4,100 萬美元，同樣創下了該部門的記錄。幽門螺旋桿菌和呼吸道類別的尿素呼氣測試推動了成長。特別是，呼吸道疾病包括 GenBody COVID-19 抗原測試的重大貢獻。

Life Science also had a record quarter with net revenues of $70 million, up 32% year-over-year. This growth was driven primarily by sales of immunological reagents, particularly, those related to COVID-19 testing. It is notable that Molecular also saw growth year-over-year in the quarter, given that we know there's been a shift away from molecular testing for COVID-19 in favor of antigen testing. Non-COVID related immuno sales were roughly flat year-over-year, attributable to the timing of orders for some of our core native antigen products, limited demand in China due to lockdowns and a one-off project in the second quarter of last year that did not repeat this year.

生命科學部門的季度淨收入也創歷史新高，達到 7,000 萬美元，年增 32%。這一增長主要是由免疫試劑的銷售推動的，特別是與 COVID-19 檢測相關的試劑。值得注意的是，鑑於我們知道 COVID-19 的分子檢測已轉向抗原檢測，Molecular 在本季度也出現了同比增長。非新冠病毒相關免疫銷售額同比大致持平，原因是我們一些核心天然抗原產品的訂單時間、中國因封鎖和去年第二季度的一次性項目而導致的需求有限今年這種情況沒有再發生。

Consolidated gross margin was 62%, with a Diagnostics margin of 50% and a Life Science margin of 68%. Diagnostics gross margin was down moderately year-over-year due the drag of LeadCare still being off the market for half of this quarter. Life Science gross margin was down due to product mix as a higher concentration of immunological sales carries a lower margin than our molecular reagents.

綜合毛利率為 62%，其中診斷毛利率為 50%，生命科學毛利率為 68%。診斷毛利率同比小幅下降，原因是 LeadCare 在本季的一半時間仍處於市場之外。生命科學毛利率因產品組合而下降，因為免疫學銷售的集中度較高，其利潤率低於我們的分子試劑。

Adjusted operating expenses were $32 million, up $6 million year-over-year, primarily due to increases in accruals for incentive compensation tied to financial performance in the current fiscal year. GAAP operating expenses were also $32 million, up $9 million versus the prior, driven by incentive compensation related to the current year's outperformance, moderate increases in G&A, sales and marketing, which were primarily offset by lower spend in R&D.

調整後營運費用為 3,200 萬美元，年增 600 萬美元，主要是由於與本財年財務表現相關的激勵薪酬應計費用增加。 GAAP 營運費用也為3,200 萬美元，比前一年增加900 萬美元，這是由於與本年度優異表現相關的激勵薪酬、一般管理費用、銷售和營銷的適度增長（主要被研發支出的減少所抵消）所推動。

Consolidated operating income on an adjusted basis was $37 million, a margin of 33%. This breaks down to an adjusted operating margin of 58% for Life Science and 4% for Diagnostics. The higher operating profit for Diagnostics was primarily driven by the incremental revenue generated in the quarter, and we expect Diagnostics to continue generating quarterly operating profit in the quarters ahead. The lower operating margin for Life Science is primarily the flow-through impact of a lower gross margin due to product mix.

調整後的綜合營業收入為 3,700 萬美元，利潤率為 33%。生命科學領域的調整後營業利益率為 58%，診斷領域的調整後營業利益率為 4%。 Diagnostics 較高的營業利潤主要是由本季產生的增量收入推動的，我們預計 Diagnostics 將在未來幾季繼續產生季度營業利潤。生命科學業務營業利潤率下降主要是因為產品組合導致毛利率下降造成的流通影響。

Adjusted diluted earnings per share was $0.66 per share, compared to $0.56 per share in the second quarter of fiscal year 2021, while GAAP diluted earnings per share with $0.65 in Q2 of 2022, compared to $0.60 in Q2 of 2021. If you'd like to dig deeper into the drivers for the second quarter of fiscal year 2022, please refer to our press release and our 10-Q, which were both filed today.

調整後稀釋每股收益為 0.66 美元，而 2021 財年第二季為 0.56 美元，而 2022 年第二季 GAAP 稀釋每股收益為 0.65 美元，而 2021 年第二季為 0.60 美元。財年第二季的驅動因素，請參閱我們今天提交的新聞稿和10-Q。

Turning to the balance sheet, as of March 31, we had $76 million in cash. During the quarter, we also repaid $25 million on our line of credit. This leaves us with borrowing capacity of $175 million. Since joining Meridian, I have been impressed with the strength of our balance sheet. I've encouraged the team to continue to leverage that in order to fortify inventory of raw materials to minimize or eliminate risks in the global supply chain, as the team has successfully done throughout the pandemic.

轉向資產負債表，截至 3 月 31 日，我們擁有 7,600 萬美元現金。本季度，我們也償還了 2500 萬美元的信用額度。這使我們的借貸能力達到 1.75 億美元。自從加入 Meridian 以來，我們的資產負債表實力給我留下了深刻的印象。我鼓勵團隊繼續利用這一點來加強原材料庫存，以最大限度地減少或消除全球供應鏈中的風險，正如該團隊在整個大流行期間成功做到的那樣。

Additionally, I've been working with our Operations and Procurement teams to further de-risk potential supply chain issues through contractual guarantees on lead times and reliability with our key suppliers, adding additional suppliers and optimizing amounts and locations of inventories, among other things. Between the cash on hand and capacity in our line of credit, we have adequate resources to fund investments and opportunities that accelerate growth and provide good returns on capital for our shareholders.

此外，我一直與我們的營運和採購團隊合作，透過與我們的主要供應商就交貨時間和可靠性提供合約保證、增加更多供應商以及優化庫存數量和位置等，進一步降低潛在供應鏈問題的風險。在我們手頭上的現金和信貸額度的能力之間，我們有足夠的資源來資助投資和機會，加速成長並為股東提供良好的資本回報。

Turning to guidance, we are raising our consolidated net revenue expectations to between $330 million and $345 million. This includes holding Diagnostics net revenue expectations between $145 million and $150 million, and raising Life Science net revenue expectations to between $185 million and $195 million. We anticipate the adjusted operating margins to be between 22.5% and 23.5%, resulting in adjusted net earnings per share of between $1.30 and $1.40.

至於指導，我們將綜合淨收入預期提高到 3.3 億美元至 3.45 億美元之間。這包括將診斷淨收入預期維持在 1.45 億美元至 1.5 億美元之間，並將生命科學淨收入預期提高至 1.85 億美元至 1.95 億美元之間。我們預計調整後的營業利潤率將在 22.5% 至 23.5% 之間，調整後的每股淨利潤將在 1.30 美元至 1.40 美元之間。

You will notice that while we have raised Life Science guidance, we are essentially holding our expectations back for the back half of the year in line with our previous guidance. As you've heard in other commentary regarding the pandemic, COVID-19 testing demand has slowed in parallel with infection rates as we exit the respiratory season. This is consistent with our expectations, which will result in a lower second half for our Life Science division, consistent with other more modest quarters we have seen following significant waves of the virus.

您會注意到，雖然我們提高了生命科學指導，但我們基本上保留了對今年下半年的預期，與先前的指導一致。正如您在有關這一流行病的其他評論中所聽到的那樣，隨著呼吸道季節的結束，COVID-19 檢測需求與感染率同步放緩。這與我們的預期一致，這將導致我們的生命科學部門下半年業績下降，與我們在病毒大流行後看到的其他較為溫和的季度一致。

I'll now turn the call back to Jack to offer some closing remarks.

現在我將把電話轉回給傑克，並發表一些結束語。

Thank you, Andy. I want to add to Andy's comments regarding the guidance. As I've mentioned before, we see COVID-19 entering the endemic phase. We believe that COVID-19 testing will continue for years to come, but with higher levels of demand in our first and second quarters aligning with the typical respiratory season. While we cannot control the spread of the virus and the resulting demand for testing, remember that our reagents are in over 100 regular assays, and whenever there is demand for testing, we will benefit. This also does not include the dozens of respiratory panels we are in, which we believe will be an important revenue driver in future periods.

謝謝你，安迪。我想補充一下安迪關於該指南的評論。正如我之前提到的，我們看到 COVID-19 進入流行階段。我們相信，COVID-19 檢測將在未來幾年繼續進行，但第一季和第二季的需求水準將與典型的呼吸道季節一致。雖然我們無法控制病毒的傳播以及由此產生的檢測需求，但請記住，我們的試劑已用於 100 多種常規檢測，只要有檢測需求，我們就會受益。這還不包括我們參與的數十個呼吸小組，我們相信這將是未來時期的重要收入驅動力。

Looking ahead to next fiscal year, we continue to believe that COVID-19 has become endemic and we will see increases in cases in testing aligned with the respiratory season annually. This will continue to follow the pattern we are expecting for this year with higher Life Science revenue in the first 2 quarters of the fiscal year, followed by lower revenues in the last 2 quarters.

展望下一個財年，我們仍然相信 COVID-19 已成為地方性流行病，我們將看到每年與呼吸道季節一致的檢測病例數增加。這將繼續遵循我們今年預期的模式，本財年前兩季生命科學收入較高，而後兩季營收較低。

While we do not expect to repeat the record level seen this year, the adoption of our Master Mixes for uses beyond COVID-19 testing, coupled with strong growth of our blocker products and other non-COVID immunoassay reagents, gives us confidence that we have an ongoing Life Science business with revenues believed to be approximately $150 million and generating operating margins of at least 50%. Diagnostics has shown signs of returning to growth and profitability and with both businesses performing strongly again, we are bullish on Meridian's future in the post-COVID world.

雖然我們預計不會重複今年的創紀錄水平，但採用我們的預混液用於COVID-19 檢測以外的用途，加上我們的阻斷劑產品和其他非COVID 免疫測定試劑的強勁增長，讓我們有信心：一項正在進行的生命科學業務，收入據信約為 1.5 億美元，營業利潤率至少為 50%。診斷業務已顯示出恢復成長和盈利的跡象，隨著兩項業務再次表現強勁，我們看好 Meridian 在後新冠疫情時代的未來。

Now Andy and I are here for any questions you may have. Operator, can you open it up for the questions please?

現在安迪和我在這裡解答您的任何問題。接線員，可以打開提問嗎？

(Operator Instructions) Our first question comes from the line of Dustin Scaringe with William Blair.

（操作員說明）我們的第一個問題來自達斯汀·斯卡林奇和威廉·布萊爾的對話。

This is Dustin on the line for Brian. For the first question, I know you gave a little bit of guidance for long-term and Life Sciences segment. It looks like in the back half of this year, you're, kind of, annualizing $130 million in the second half. Is it fair to assume that this business is going to grow, kind of, double digits organically off of this in 2023?

我是達斯汀，正在接聽布萊恩的電話。對於第一個問題，我知道您為長期和生命科學領域提供了一些指導。看起來今年下半年，下半年的年化收入約為 1.3 億美元。假設該業務將在 2023 年實現兩位數的有機成長，是否公平？

Yes, we do believe that we have a double-digit growing Life Science business. So the big question for everybody of course, is where's your jump-off point with COVID? So our general view of the approximately $150 million business is that you have some element of COVID in there, and then you've got the underlying rest of the business. But we are anticipating a low double-digit growing Life Science business as we go forward. We believe we've got that in the tank and then some.

是的，我們確實相信我們的生命科學業務有兩位數的成長。當然，對每個人來說，最大的問題是，你應對新冠病毒的出發點在哪裡？因此，我們對約 1.5 億美元業務的總體看法是，其中包含了一些新冠疫情元素，然後才是該業務的其他基礎部分。但我們預計，隨著我們的發展，生命科學業務將出現兩位數的低成長。我們相信我們已經把它儲存起來了，而且還不只這些。

Great. And then on a Diagnostics business, I know you didn't really, kind of, guide to the second quarter, but it looks like you beat us by about $7 million but kept the guide flat. I know LeadCare was in there and came back a little sooner than earlier. But just wondered what's going on the back half of the year, because that still, kind of, looks conservative.

偉大的。然後在診斷業務方面，我知道你們並沒有真正對第二季度做出預測，但看起來你們比我們領先了約 700 萬美元，但保持了預測不變。我知道 LeadCare 就在那裡，而且比之前早一點回來了。但只是想知道今年下半年會發生什麼，因為這看起來仍然有點保守。

So our Diagnostics business, we're at about $74 million at the midpoint of the year, and we're guiding to that being essentially at the 50% point of our guidance, if you will. And the way we look at it, Dustin, first of all, is that we have some elements of seasonality in our Diagnostic business. And Andy, you can add to this at the end if you want, but we certainly have a stronger respiratory season typically in our Diagnostic business. So that, kind of, decreases it as you move into Q3 and Q4. But as we get into Q4, we do see some seasonality with some of the food products as well as LeadCare and other things. So we do feel that the guidance we have, we're holding it for the year. We think that it's on track for that, but high-30s types of quarters is, kind of, what we see in these Q3, Q4 types of quarters going forward.

因此，我們的診斷業務在今年年中約為 7,400 萬美元，如果您願意的話，我們的指導基本上是我們指導的 50%。達斯汀，我們首先認為我們的診斷業務具有一些季節性因素。安迪，如果您願意，您可以在最後添加這一點，但我們的診斷業務通常會經歷一個更強勁的呼吸季節。因此，當您進入第三季和第四季時，它會有所減少。但當我們進入第四季度時，我們確實看到一些食品以及 LeadCare 和其他產品存在一些季節性。因此，我們確實認為我們今年將堅持現有的指導方針。我們認為這已步入正軌，但 30 多歲的季度類型是我們在未來第三季、第四季類型的季度中看到的。

So Andy, I don't know if you want to add to that.

安迪，我不知道你是否想補充這一點。

No, I would say one thing I've noticed is that the breath products that the team has brought on in the last 2 or 3 years have really performed well and I think they're a strength to build on, so it doesn't seem to be any issue to be hitting that those numbers Jack said.

不，我想說的是，我注意到的一件事是，該團隊在過去 2 或 3 年中推出的呼吸產品確實表現良好，我認為它們是一種可以繼續發展的優勢，所以它不傑克所說的這些數字似乎是有問題的。

Okay. And then commentary on M&A, I'm wondering if you can give us a little more perspective on that, what you're seeing in the landscape right now for other deals, especially in the Life Sciences segment where it seems like the market is particularly fragmented.

好的。然後是關於併購的評論，我想知道您是否能為我們提供更多關於這一點的看法，您現在在其他交易中看到的情況，特別是在生命科學領域，該領域的市場似乎尤其如此支離破碎。

Yes. So we've -- over the last 3 plus years, we've really worked to build a more consistent approach to M&A, and it's, what -- this is our fourth acquisition now in about 3 years that we've done. So we have a more programmatic approach to our M&A, Charlie's been a big part of helping us to build that out. We've got the systems in place to assess opportunities, to build a funnel and to really work them through the funnel. And as well as of course, then integrating them on the back end for the ones that we do decide to acquire.

是的。因此，在過去三年多的時間裡，我們確實致力於建立一種更一致的併購方法，這是我們在大約三年內所做的第四次收購。因此，我們對併購採取了更程序化的方法，而查理在幫助我們實現這一目標方面發揮了重要作用。我們已經建立了適當的系統來評估機會、建立漏斗並真正透過漏斗來運作它們。當然，然後將它們整合到我們決定收購的後端。

So we're very excited about EUPROTEIN. It's a small bolt-on situation for us, but it's a technology enhancement that's going to really help us in our business. So we're excited to bring that one on. We do have a continual funnel that we're looking for in the Life Science, whether it be small bolt-ons. There are also some large assets that are out there that we certainly will look at to see if they make sense for us.

所以我們對 EUPROTEIN 感到非常興奮。這對我們來說只是一個小補充，但它是一項技術增強，將真正幫助我們的業務。所以我們很高興能推出這項產品。我們確實在生命科學中尋找一個連續的漏斗，無論它是小螺栓。我們當然也會專注在一些大型資產，看看它們對我們是否有意義。

Life Science valuations have historically been a bit challenging. So we're, kind of, keeping an eye on some of those valuations as we go forward. But I think you can expect us to continue to look to use our cash to acquire things to strengthen the overall Life Science business. Andy, I don't know if you want to that.

從歷史上看，生命科學的估值有點具有挑戰性。因此，在我們前進的過程中，我們會密切注意其中的一些估值。但我認為您可以期望我們繼續尋求使用我們的現金來收購東西以加強整個生命科學業務。安迪，我不知道你是否願意。

[That's right.]

[這是正確的。

Our next question comes from the line of Yi Chen with H.C. Wainwright.

我們的下一個問題來自陳毅和 H.C. 的對話。溫賴特。

This is [Chase] on behalf of Yi. Congratulations on all the progress. You've already answered a few of my questions in your previous response, but I was just wondering if you could perhaps summarize all the catalysts or events across both your business units that we should definitely keep an eye out for in the coming months this year.

這是代表易的【追】。祝賀所有的進展。您已經在先前的回覆中回答了我的一些問題，但我只是想知道您是否可以總結一下您的兩個業務部門中我們在今年接下來的幾個月中絕對應該關注的所有催化劑或事件。

So I'll throw some and Andy, you can wrap around me. So first of all, on the Life Science side of things, as you guys know, as we move into the endemic phase, we're going into a new phase on the Life Science side of the business. So for us, it will be harder to predict what happens with the COVID part of our business, because we're not exactly sure what'll happen in the endemic environment. But for us, there are some key things that we're doing on the Life Science side. This acquisition of EUPROTEIN is a good signal that we believe that there's real opportunities for us, not just on the molecular side of things, our mixes -- Master Mixes continue to do great in the market. We think there's real opportunity on the immunoassay side of the business as well.

所以我會丟一些，安迪，你可以圍著我。首先，在生命科學方面，正如你們所知，當我們進入流行階段時，我們將進入生命科學方面業務的新階段。因此，對我們來說，預測我們業務中的新冠疫情部分會發生什麼將變得更加困難，因為我們不確定在流行環境中會發生什麼。但對我們來說，我們在生命科學方面正在做一些關鍵的事情。此次收購 EUPROTEIN 是一個很好的訊號，表明我們相信我們擁有真正的機會，不僅僅是在分子方面，我們的混合物 - Master Mixes 繼續在市場上表現出色。我們認為免疫分析業務方面也存在真正的機會。

And so strengthening our capabilities with recombinant proteins and bringing new products to market there. Looking at non-animal derived products over time is something that we're working on as well to move to more recombinant in general and moving away from native antigens.

因此，我們加強了重組蛋白的能力，並將新產品推向市場。隨著時間的推移，我們也在研究非動物性產品，以轉向更多的重組產品並遠離天然抗原。

So we see strong growth in our Life Science business, clearly from the Master Mixes that we have as we work to get them into more and more assays, non-COVID related assays. Those are happening as we speak, but as you know, the regulatory process, it's a long process. So we have a lot in the funnel that we're working there. And then the immunoassay piece is really the other key growth area that we wanted to accelerate with this acquisition.

因此，我們看到生命科學業務的強勁成長，這從我們擁有的預混料中可以明顯看出，因為我們正在努力將它們用於越來越多的檢測、非新冠病毒相關的檢測。正如我們所說，這些正在發生，但正如你所知，監管過程是一個漫長的過程。因此，我們正在那裡進行很多工作。免疫分析領域確實是我們希望透過此次收購加速的另一個關鍵成長領域。

On the Diagnostic side of things, for us getting the LeadCare II back and getting it back early was really important to us. As you know, we have the only point-of-care led testing available on the market, and there's really a strong need in the marketplace for this type of testing. And so we were really excited to get that back. We're actively working with our customers to make sure that they're up and running again, that they're utilizing the technology. And so for us, it's about what can we produce in the near term, but ultimately going back to focusing on the organic growth. So we are optimistic that we are seeing a significant number of placements of new systems in that area that we look forward to reporting as we go forward. So I think that that's going to be a continued nice area for us. The leadCare should provide a nice tailwind for us as we go forward in the coming years.

在診斷方面，對我們來說，收回 LeadCare II 並儘早收回它對我們來說非常重要。如您所知，我們擁有市場上唯一可用的即時護理主導測試，並且市場對此類測試確實有強烈的需求。因此，我們非常高興能夠收回這一點。我們正在積極與客戶合作，確保他們能夠重新啟動並運行，並利用該技術。因此，對我們來說，重要的是我們在短期內能生產什麼，但最終還是要回到專注於有機成長。因此，我們樂觀地認為，我們在該領域看到了大量新系統的部署，我們期待在未來進行報告。所以我認為這對我們來說將是一個持續的好領域。在我們未來幾年的前進過程中，leadCare 應該會為我們提供良好的推動力。

Andy also mentioned the urea breath testing, that is a huge area for us. We have a strong H. pylori franchise between H. pylori stool antigen, and the urea breath testing. And our position there is one that we think that can provide good tailwind to us in that business. So you have other forms of testing, like we talked about, that we can convert over to urea breath testing that we think can provide continual tailwind, if you will, to that business.

安迪也提到了尿素呼氣測試，這對我們來說是一個很大的領域。我們在幽門螺旋桿菌糞便抗原和尿素呼氣測試之間擁有強大的幽門螺旋桿菌專營權。我們認為我們的立場可以為我們在該業務中提供良好的推動力。因此，您可以進行其他形式的測試，就像我們談到的那樣，我們可以將其轉換為尿素呼氣測試，我們認為如果您願意的話，可以為該業務提供持續的推動力。

So those are a couple key areas. Of course, getting the Revogene COVID assay is important for us. We have a lot of customers in those smaller hospitals that really still are looking for this technology. And so I think that'll open up things for us. So those are some of the key things. Andy, sorry that I jumped all over you there and I took them all.

這些是幾個關鍵領域。當然，獲得 Revogene COVID 檢測對我們來說很重要。我們在那些規模較小的醫院裡有很多客戶，他們仍然在尋找這項技術。所以我認為這將為我們打開局面。這些是一些關鍵的事情。安迪，對不起，我跳到了你身上，把它們都拿走了。

That's great.

那太棒了。

Look, I will tell you this, we're excited about both businesses and thankfully we invested heavily in Diagnostics over the last couple of years, even when we knew the business was going to suffer during COVID. And now we're starting to see the fruits of that at this point, with our breath business starting to flourish. So we're extremely optimistic for both of our businesses as we go forward.

聽著，我會告訴你這一點，我們對這兩項業務感到興奮，值得慶幸的是，我們在過去幾年中在診斷方面投入了大量資金，即使我們知道該業務將在新冠疫情期間遭受損失。現在我們開始看到這一點的成果，我們的呼吸事業開始蓬勃發展。因此，隨著我們的發展，我們對這兩項業務都非常樂觀。

There are no further questions in the queue. I'd like to hand the call back over to Mr. Kenny for closing remarks.

隊列中沒有其他問題。我想將電話轉回給肯尼先生做總結發言。

Thank you very much, Operator. Well, thank you all for joining the call today. We really enjoyed speaking with you again this quarter. This was an exciting quarter for Meridian and certainly we have a bright future ahead of us. We look forward to sharing with you at future conferences or, quite frankly, on these calls as we go forward. Have a great day. Thank you.

非常感謝您，接線生。好的，謝謝大家今天加入電話會議。我們非常高興本季再次與您交談。對於 Meridian 來說，這是一個令人興奮的季度，我們當然擁有光明的未來。我們期待在未來的會議上，或者坦白說，在我們前進的這些電話會議上與您分享。祝你有美好的一天。謝謝。

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time and have a wonderful day.

女士們、先生們，今天的電話會議到此結束。感謝您的參與。此時您可以斷開線路並度過美好的一天。