OraSure Technologies Inc (OSUR) 2026 Q1 法說會逐字稿

Good day and thank you for standing by. Welcome to the OraSure Technologies Incorporated 2026 First Quarter Earnings Conference Call. (Operator Instructions) Be advised that today's conference call is being recorded.

各位好，感謝您稍候。歡迎參加 OraSure Technologies Incorporated 2026 年第一季財報電話會議。（接線員指示）提醒您，今日的電話會議將被錄音。

I would now like to hand the conference over to your first speaker today, Jason Plagman, Vice President of Investor Relations. Please go ahead.

現在我想把會議交給今天的第一位講者，投資人關係副總裁 Jason Plagman。請開始。

Good afternoon, and welcome to OraSure Technologies' first-quarter 2026 earnings call. Participating in the call today for OTI are Carrie Eglinton-Manner, our President and Chief Executive Officer; and Ken McGrath, our Chief Financial Officer.

各位下午好，歡迎參加 OraSure Technologies 2026 年第一季財報電話會議。今天代表 OTI 參與會議的有：我們的總裁兼執行長 Carrie Eglinton-Manner，以及財務長 Ken McGrath。

As a reminder, today's webcast is being recorded, and the recording can be found on our Investor Relations website.

提醒各位，今天的網路直播將被錄音，錄音可於我們的投資人關係網站上取得。

Before we begin, you should know that this call may contain certain forward-looking statements, including statements with respect to revenues, expenses, profitability, earnings or loss per share, and other financial performance, product development, performance, shipments and markets, business plans, regulatory filings and approvals, expectations, and strategies. Actual results could be significantly different.

在開始之前，請注意本次電話會議可能包含若干前瞻性陳述，包括關於營收、費用、獲利能力、每股盈餘或每股虧損及其他財務表現、產品開發、表現、出貨與市場、營運計畫、法規申報與核准、預期與策略等之陳述。實際結果可能會有重大差異。

Factors that could affect results are discussed more fully in OTI's SEC filings, its annual report on Form 10-K for the year ended December 31, 2025, its quarterly reports on Form 10-Q, and its other SEC filings.

可能影響結果的因素已在 OTI 向 SEC 提交的文件中更完整地說明，包括截至 2025 年 12 月 31 日止年度的 Form 10-K 年報、Form 10-Q 季報，以及其他 SEC 申報文件。

Although forward-looking statements help to provide more complete information about future prospects, listeners should keep in mind that forward-looking statements are based solely on information available to management as of today.

儘管前瞻性陳述有助於提供對未來展望更完整的資訊，聽眾仍應注意，前瞻性陳述僅基於管理階層截至今日可取得的資訊。

OTI undertakes no obligation to update any forward-looking statements to reflect events or circumstances after this call.

OTI 不承擔更新任何前瞻性陳述以反映本次電話會議後事件或情況之義務。

With that, I am pleased to turn the call over to Carrie.

接下來，我很高興把電話會議交給 Carrie。

Thanks, Jason, and thank you to everyone for joining us today. Today, I'll discuss some highlights from Q1 and provide updates on our key priorities for 2026.

謝謝你，Jason，也感謝各位今天加入。我將分享第一季的一些重點，並更新我們 2026 年的關鍵優先事項進展。

Overall, we continue to advance our strategic transformation and execute with discipline as we focus on driving growth in 2026 and beyond. We have delivered meaningful progress over the last few years and continue strengthening our foundation, including leveraging our manufacturing capabilities and capacity to drive gross margin expansion, while also streamlining our cost structure.

整體而言，我們持續推進策略轉型並以紀律執行，聚焦於推動 2026 年及未來的成長。過去幾年我們已取得具體進展，並持續強化基礎，包括運用我們的製造能力與產能來推動毛利率擴張，同時精簡成本結構。

We're also elevating our core growth by expanding and diversifying our product portfolio and customer relationships, while several of our key end markets adapt to an evolving funding environment.

我們也透過擴充並多元化產品組合與客戶關係來提升核心成長，同時我們的幾個主要終端市場也在因應不斷變化的資金環境。

Ultimately, we're accelerating profitable growth through investments in R&D, targeting high-value growth markets, as well as acquisitions and partnerships that leverage our existing capabilities and provide an attractive risk-adjusted ROI.

最終，我們透過研發投資、鎖定高價值成長市場，以及進行能運用既有能力並提供具吸引力風險調整後投資報酬率（ROI）的併購與合作夥伴關係，加速實現獲利性成長。

We're also preparing for several near-term catalysts for growth, including our two product launches planned for mid-year. One, our rapid molecular self-test for chlamydia and gonorrhea, also known as CT&G, and two, our Colli-Pee at-home urine collection device for sexually transmitted infections, or STIs.

我們也在為數個短期成長催化劑做準備，包括預計於年中推出的兩項產品：第一，我們的披衣菌與淋病快速分子自我檢測（亦稱 CT&G）；第二，我們用於性傳染感染（STIs）的 Colli-Pee 居家尿液採集裝置。

Looking at our Q1 results, total revenue was $27.9 million, which was above the midpoint of our guidance range, and we generated solid gross margin expansion.

就第一季結果而言，總營收為 2,790 萬美元，高於我們指引區間的中點，且我們實現了穩健的毛利率擴張。

In our international diagnostics business, we made significant progress on our initiatives to establish closer relationships with some of our distribution partners in Africa. And their in-country value-added assembly and manufacturing, also known as nearshoring.

在國際診斷業務方面，我們在與非洲部分經銷合作夥伴建立更緊密關係的各項計畫上取得顯著進展，以及其在地增值組裝與製造（亦稱近岸外包／近岸製造，nearshoring）。

During Q1, we delivered on initial orders to one of our nearshoring partners. We anticipate initial orders from other partners in the second-half of the year, and we believe this trend represents a significant opportunity in rebuilding momentum in health program implementation in countries around the globe.

第一季期間，我們已向其中一家 nearshoring 合作夥伴交付初始訂單。我們預期今年下半年將收到其他合作夥伴的初始訂單，並相信此趨勢在重建全球各國健康計畫推動動能方面代表一項重大機會。

Additionally, our international team is building positive momentum with the integration of Biomedomics into our sales channels, and then expanding the reach of SickleScan into new markets through our relationships with national health programs.

此外，我們的國際團隊正透過將 Biomedomics 整合進我們的銷售通路來建立正向動能，並藉由與國家健康計畫的合作關係，將 SickleScan 的觸及範圍擴展至新市場。

In our US Diagnostics business, our public health customers are stabilizing as they adapt to the current budget environment. In general, HIV testing programs remain a key priority for state and local public health agencies to control the spread of the virus and to manage downstream cough. In the healthcare system.

在美國診斷業務方面，公共衛生客戶正隨著其因應目前的預算環境而趨於穩定。整體而言，HIV 檢測計畫仍是州與地方公共衛生機構的關鍵優先事項，以控制病毒傳播並管理後續咳嗽。在醫療體系中。

We are also seeing traction in demand resulting from our syndemic approach that leverages our portfolio of rapid tests across multiple conditions, including HIV, HCV, and syphilis, to deliver value and ease of use for customers.

我們也看到需求因我們的「共病流行（syndemic）」策略而有所進展；該策略運用我們涵蓋多種疾病的快速檢測產品組合（包括 HIV、HCV 與梅毒），為客戶提供價值與易用性。

Switching gears to sample management solutions, we are seeing gradual improvement with commercial customers, including advanced genetic testing labs, driven by increasing utilization of precision medicine that leverages genetic insights to identify risk factors for cancer and other conditions, as well as diagnosis of rare diseases.

轉到樣本管理解決方案方面，我們看到商業客戶（包括先進基因檢測實驗室）逐步改善，主要受精準醫療使用率提升所帶動；精準醫療運用基因洞見來辨識癌症及其他疾病的風險因子，並協助罕見疾病的診斷。

During Q1, growth in commercial segments was offset by muted demand in academic and government markets related to the continued slow pace of NIH research grants funding.

第一季，商業領域的成長被學術與政府市場相對疲弱的需求所抵銷，原因與 NIH 研究補助金資助進度持續緩慢有關。

That said, we remain confident that the sample management business is positioned to deliver growth in 2026 and beyond as genomic end segments gradually return to stronger growth.

即便如此，我們仍有信心樣本管理業務已具備在 2026 年及未來帶來成長的定位，因為基因體相關終端市場將逐步回到更強勁的成長。

Next, I'll transition to our innovation and product pipeline, which includes several important near-term catalysts for growth in attractive markets, as well as our pipeline of earlier stage opportunities and high-value growth markets.

接下來我將談到我們的創新與產品管線，其中包含數個在具吸引力市場中的重要短期成長催化劑，以及我們較早期機會與高價值成長市場的管線。

From a regulatory standpoint, our two applications for FDA clearances are in the review process. We continue to anticipate mid-year clearances and expect that revenue from product launches will ramp in the second half of the year.

就法規進度而言，我們兩項 FDA 核准申請目前正在審查中。我們仍預期於年中取得核准，並預期產品上市帶來的營收將在下半年加速成長。

As a reminder, our two submissions were for our over-the-counter rapid self-test for CTNG that is built on the Sherlock Molecular Diagnostics platform and our Colli-Pee device for STIs. The Colli-Pee submission, which includes its proprietary stabilization chemistry, covers multiple STI indications and is being pursued in collaboration with a leading diagnostics platform provider.

提醒各位，我們的兩項送件分別為：基於 Sherlock Molecular Diagnostics 平台打造的 CTNG 非處方（OTC）快速自我檢測，以及用於 STIs 的 Colli-Pee 裝置。Colli-Pee 的送件包含其專有的穩定化化學配方，涵蓋多項 STI 適應症，並與一家領先的診斷平台供應商合作推進。

These two submissions, with their potential clearances, reflect our progress on our innovation roadmap, and demonstrate how we are advancing our vision to help decentralize diagnostics and connect people to care that is more accessible, convenient, affordable, and private.

這兩項送件及其潛在核准，反映我們在創新路線圖上的進展，並展現我們如何推動願景：協助診斷去中心化，並讓人們更容易連結到更可近、更便利、更可負擔且更具隱私性的照護。

With that, I'll turn the call over to Ken to discuss our financial results and guidance.

接下來我把電話會議交給 Ken，請他說明我們的財務結果與指引。

Thanks, Carrie.

謝謝你，Carrie。

Total revenue in the first quarter was $27.9 million and grew 4% on a sequential basis. Diagnostic products generated $16.9 million of revenue in Q1, with a fairly even split between US and international revenue. Diagnostics revenue grew 12% on a sequential basis. Sample Management Solutions revenue in Q1 was $9.1 million, which was basically flat on a sequential basis.

第一季總營收為 2,790 萬美元，較前一季成長 4%。第一季診斷產品營收為 1,690 萬美元，美國與國際營收占比相當平均。診斷營收較前一季成長 12%。第一季樣本管理解決方案營收為 910 萬美元，較前一季基本持平。

Our GAAP gross margin in the first quarter was 42.3% compared to 41.1% in Q1 2025. And non-GAAP gross margin in Q1 increased to 43.4% compared to 41.7% in Q1 2025.

第一季 GAAP 毛利率為 42.3%，相較於 2025 年第一季的 41.1%。第一季非 GAAP 毛利率提升至 43.4%，相較於 2025 年第一季的 41.7%。

Gross margin expansion was driven by operating efficiencies, largely related to our initiatives to in-source production from third-party contract manufacturers into our Pennsylvania facilities. This transition leverages our advanced manufacturing capabilities and capacity developed during the COVID pandemic.

毛利率擴張主要由營運效率提升所帶動，主要與我們將原由第三方委外代工廠生產的產品轉回賓夕法尼亞州自有廠房內製（in-source）的計畫相關。此一轉換運用了我們在 COVID 疫情期間建立的先進製造能力與產能。

Looking at GAAP operating expenses in Q1, R&D expense was $13.7 million, sales and marketing expense was $6.8 million, and general and administrative expense was $14.6 million. The increase in R&D was primarily driven by investments in activities related to launch preparation and production readiness for our CTNG test and our colleague P device, including studies gathering data that we believe will position us for successful commercial go-to-market launch.

就第一季 GAAP 營業費用而言，研發費用為 1,370 萬美元，銷售與行銷費用為 680 萬美元，一般與行政費用為 1,460 萬美元。研發費用增加主要由與我們 CTNG 檢測與 Colli-Pee 裝置上市準備及量產就緒相關活動的投資所驅動，包括蒐集數據的研究；我們相信這些將使我們具備成功的商業化上市（go-to-market）條件。

We expect our R&D expense to taper down during Q2 and Q3.

我們預期研發費用將在第二季與第三季逐步下降。

Looking at G&A expense, the sequential increase in Q1 was primarily driven by non-recurring items, including severance expense related to a reduction in force in February, professional services related to our proxy and the annual reset of accruals for performance-based incentive compensation programs. We expect G&A expense to decline to more normalized levels beginning in Q3, following the conclusion of the non-recurring items I mentioned.

就一般與行政費用而言，第一季較前一季增加主要由一次性項目所致，包括 2 月裁員所產生的資遣費用、與我們委託書（proxy）相關的專業服務費用，以及以績效為基礎之獎酬計畫應計項目的年度重設。我們預期在我所提及的一次性項目結束後，自第三季起一般與行政費用將下降至較正常水準。

Non-cash stock compensation expense in the first quarter was $2.8 million and depreciation amortization expense was $2.3 million.

第一季非現金股票薪酬費用為280萬美元，折舊與攤銷費用為230萬美元。

Our GAAP operating loss in Q1 was $23.3 million and our non-GAAP operating loss was $19 million.

我們第一季的GAAP營業虧損為2,330萬美元，非GAAP營業虧損為1,900萬美元。

Moving to our balance sheet, we ended the quarter with zero debt and total cash and cash equivalents of $177 million. During the first quarter, we deployed $5 million to repurchase 1.8 million shares of our common stock. Over the last four quarters, we have returned $20 million of capital to shareholders through the repurchase of 7.1 million shares.

接著看資產負債表，我們在本季末零負債，現金及約當現金總額為1.77億美元。第一季期間，我們動用500萬美元回購180萬股普通股。過去四個季度，我們透過回購710萬股，向股東返還2,000萬美元資本。

Consistent with our balanced capital deployment strategy, we continue to evaluate organic and inorganic opportunities that can accelerate our profitable growth in high-value markets and leverage our existing capabilities.

秉持我們均衡的資本配置策略，我們持續評估可加速我們在高價值市場實現獲利成長、並運用既有能力的內生成長與外延併購機會。

Operating cash flow in the first quarter was negative $14 million, which was consistent with our expectations. As we discussed in February, we expect to return to breakeven from an operating cash flow standpoint as we enter 2027.

第一季營運現金流為負1,400萬美元，符合我們的預期。如同我們在2月所討論的，從營運現金流角度來看，我們預期在進入2027年時可回到損益兩平。

This view is supported by our outlook for revenue growth, including contributions from our anticipated product launches, as well as our continued focus on delivering cost savings and operating efficiencies.

此觀點受到我們對營收成長的展望所支持，其中包括預期產品上市的貢獻，以及我們持續聚焦於實現成本節省與營運效率提升。

Moving to guidance, we expect revenue in the second quarter of $27 million to $30 million, which includes a negligent amount of revenue for COVID-19 testing.

接著談財測，我們預期第二季營收為2,700萬至3,000萬美元，其中包含極少量的COVID-19檢測營收。

We expect our gross margin in Q2 to be similar to Q1. We anticipate our operating expense will be in the high $20 million range in Q2, which includes non-run rate expenses and excludes stock compensation. Then we expect operating expenses to decline further to the mid-20 millions in Q3 as non-run rate expenses wind down.

我們預期第二季毛利率將與第一季相近。我們預估第二季營業費用將落在2,000多萬美元的高端區間，包含非經常性費用並排除股票薪酬。接著，隨著非經常性費用逐步結束，我們預期第三季營業費用將進一步下降至2,000多萬美元的中段區間。

With that, I'll turn the call back to Carrie to conclude.

接下來，我把電話交回給Carrie做結語。

Thanks, Ken. As we move through 2026, OraSure is positioned to accelerate our growth as we approach a series of regulatory and commercial milestones, and we continue to transform our business as we deliver on our strategy to decentralize diagnostics.

謝謝你，Ken。隨著我們邁入2026年，OraSure在一系列法規與商業里程碑逐步到來之際，已具備加速成長的有利位置；同時，我們也持續推動業務轉型，落實我們去中心化診斷的策略。

We are excited about all of our opportunities, near-term and long-term, to expand our portfolio with our innovative product pipeline and our ability to leverage our manufacturing capabilities and capacity as we work to create value for our customers and all shareholders.

我們對所有機會—無論短期或長期—都感到振奮，將透過創新產品管線擴充產品組合，並運用我們的製造能力與產能，為客戶及全體股東創造價值。

With that, I'm pleased to turn the call over to the operator for Q&A. Tyler?

接下來，我很高興把電話交給接線員進行問答。Tyler？

(Operator Instructions) Patrick Donnelly, Citi.

（接線員指示）Citi的Patrick Donnelly。

Hi, this is [Brendan] on for Patrick. Thank you so much for taking your questions and congrats on the quarter. I just want to start on the nearshoring initiative. It's great to see orders kind of start to come through there. I was wondering if you'd be able to size those and down the line as more are added, what those could potentially turn into from a revenue standpoint.

嗨，我是代替Patrick的[Brendan]。非常感謝你們回答問題，也恭喜本季表現。我想先從近岸外包（nearshoring）計畫談起。很高興看到訂單似乎開始進來了。我想請問你們能否量化這些訂單規模？以及未來隨著更多訂單加入，從營收角度看，可能會帶來什麼樣的貢獻。

And then also along those lines, can you talk about what the pipeline kind of looks like to add more types to that program?

另外同樣相關地，你們能談談這個計畫要新增更多類型時，整體管線大概長什麼樣子嗎？

Thanks, Brendan. So as far as nearshoring, we're really excited about the opportunity. And just for background, this is something that we've been working with these countries for several years to put in place. We did -- we said it was significant. We haven't given an exact number as far as dollars, but you can imagine in the millions is significant for us.

謝謝你，Brendan。就近岸外包而言，我們對這個機會非常興奮。先補充背景：我們與這些國家合作推動此事已經好幾年，才逐步建立起來。我們確實說過這是「顯著」的機會。我們尚未提供以美元計的確切數字，但你可以想像，對我們而言，數百萬美元等級就是顯著。

And not all will be all all relationships will be in that range, but we are seeing good progress as we continue to advance conversations and initiate nearshoring opportunities with other countries as well.

當然，並非所有合作關係都會落在那個規模，但隨著我們持續推進對話，並與其他國家啟動近岸外包機會，我們確實看到良好進展。

Thank you. And then to touch on the margins, did we use it? It's good to be first quarter kind of come in ahead of expectations. Do you kind of view this as a new baseline for gross margins? And is there more internal, like, initiative that you guys are planning on implementing to kind of further that margin expansion? Thank you.

謝謝。再談毛利率方面，我們是否已經用到了？第一季表現優於預期很不錯。你們是否把這視為毛利率的新基準？另外，你們是否規劃更多內部措施來進一步推動毛利率擴張？謝謝。

Yeah, thanks. And yeah, so what we said is Q2 would be similar to Q1. What we're seeing as far as tailwinds for improving our margins is our operation efficiency, which you may recall, we've talked about in the past where we consolidated our manufacturing into some core operation facilities.

好的，謝謝。是的，我們說過第二季會與第一季相近。就推動毛利率改善的順風因素而言，我們看到的是營運效率提升；你可能記得我們過去提過，我們已將製造整併至幾個核心營運據點。

As we take advantage of that operating efficiency overall on our improved absorption and in addition, as we increase our volumes, we will continue to see improvements in our gross margin. That could be offset, obviously, time to time by mix and other dynamics that play out within our margins. But we're encouraged by the strong tailwinds that we have.

隨著我們整體營運效率提升、吸收率改善，此外，當我們提高出貨量時，毛利率也會持續改善。當然，這可能會不時受到產品組合與其他影響毛利率的動態所抵銷。但我們對目前強勁的順風因素感到鼓舞。

Mac Etoch, Stephens.

Stephens的Mac Etoch。

Hey, good afternoon, and thank you for you on the outlook for the CT&G test. As you approach the launch of these products, I assume the commercial teams are already advancing discussions around the agreements and partnerships. What progress have you made on that front so far, and how should we think about the early commercialization direction there?

嗨，午安，謝謝你們對CT&G檢測的展望說明。隨著你們接近這些產品的上市，我猜商務團隊應該已在推進協議與合作夥伴的討論。到目前為止你們在這方面取得了哪些進展？我們應該如何看待早期商業化的方向？

Hi, Mac. You're right in that when you have the product launch expectation, everybody starts gearing up. There is an important distinction to be made, of course, as you well know in FDA, with FDA-cleared products, unlike research use only, you really can't pre-market.

嗨，Mac。你說得對，當預期產品即將上市時，大家都會開始做準備。不過需要做一個重要區分：如你所知，對於FDA核准（cleared）的產品，不同於僅供研究用途（RUO），你其實不能在上市前進行行銷。

We do, of course, well understand market interest and opportunity in infectious disease, in STIs, in sample collection and urine collection because we have such strong portfolios there today. So we've done good market research. We stay very connected to these customers.

當然，我們非常了解市場對傳染病、性傳染感染（STIs）、檢體採集與尿液採集的興趣與機會，因為我們目前在這些領域已有非常強的產品組合。因此我們做了充分的市場研究，也與這些客戶保持非常緊密的連結。

We're thinking about the kinds of conversations you can. Ahead of time, which is really about how the whole test-to-treat system would work upon clearance. And so I'd say it's those dialogues that are all within bounds that really give a sense for the enthusiasm and interest to make STI testing private, convenient, affordable, accessible, and that make urine self-collection. And something that can be done outside of a doctor's office.

我們也在思考哪些對話可以提前進行，主要是圍繞一旦獲得核准後，整個「檢測到治療」（test-to-treat）系統將如何運作。我會說，正是這些在合規範圍內的對話，讓我們感受到市場對於讓STI檢測更具隱私性、便利性、可負擔性與可近性，以及推動尿液自我採集、並可在診間之外完成的熱情與興趣。

So, yeah, I kind of frame it that way. But with the FDA process, we're also very smart and compliant around not pre-marketing.

所以，是的，我大概會這樣框架。但在FDA流程下，我們也非常謹慎且合規，不會進行上市前行銷。

Fair enough. I appreciate the color there. And maybe following up on the margin question, I appreciate the color that you gave, Ken.

了解。謝謝你提供的補充說明。也許接著追問毛利率問題，我也謝謝你剛才給的細節，Ken。

But just thinking about the launch of some of these products that you have in the pipeline, should we expect any, maybe near-term volatility or, decremental margins just as we think about near-term margin progression?

不過從你們管線中部分產品的上市來看，我們是否應預期短期內會有一些波動，或是隨著近期毛利率走勢出現一些遞減的毛利率壓力？

I'll tell you what we said in the past, and we'll be answering your question as I go through that. So what we've said for CT&G is in the fullness of time, it will be accretive to our overall margins. But to your point, there's a ramp-up of that. When your volumes start out lower, you don't have as good margins. So we will experience some of that as we ramp up.

我會先重述我們過去說過的內容，並在過程中回答你的問題。我們對CT&G的說法是：從長期來看，它將提升（具增益性）我們整體毛利率。但如你所指出的，這需要爬坡期。當初期量較低時，毛利率不會那麼好。因此在我們放量的過程中，確實會經歷部分這樣的情況。

For our Colli-Pee device, similar. We expect margins in the fullness of time to be equal or accretive to our overall current margins, but there is that ramp-up time that takes place, to your point, as we ramp up the volumes and kind of get that full absorption over time.

至於Colli-Pee裝置也類似。我們預期從長期來看，其毛利率將與我們目前整體毛利率相當或具增益性；但如你所說，隨著我們提升出貨量並逐步達到充分吸收，確實會有一段爬坡期。

I appreciate the color there. Thank you all for taking my questions.

謝謝你提供的補充說明。也謝謝各位回答我的問題。

Thanks, Mac.

謝謝你，Mac。

Thank you. I am showing no further questions at this time. I would now like to turn it back to Carrie for closing remarks.

謝謝。目前顯示沒有其他提問。我現在把電話交回給Carrie做結語。

Thanks, Tyler, and just thank you to everyone for joining us. We hope you have a great day. And with that, we'll close the call. Thanks.

謝謝你，Tyler，也謝謝大家參與。我們祝大家有美好的一天。那麼，我們就結束本次電話會議。謝謝。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝您參與今天的電話會議。本節目到此結束。您現在可以掛線。