アウトセット・メディカル（OM）2026年第3四半期決算説明会：売上高14%増、ガイダンス据え置き

要点

• アウトセット・メディカルが発表した2026年第3四半期の売上高は、前年同期比14%増、前期比6%増の3,360万ドルとなり、すべての収益区分で増収を達成した。
• コンソール売上高は前年同期比26%増の1,050万ドルとなった。消耗品、サービス、透析治療件数、およびEMR（電子カルテ）導入の拡大に支えられ、リカーリング収益は10%増の2,310万ドルに増加した。
• Non-GAAP売上総利益率は約100ベーシスポイント（bp）改善して40.8%となった。また、営業レバレッジは300bp以上向上した。
• 経営陣は2026年通期の売上高ガイダンスを1億2,500万〜1億3,000万ドルに据え置き、Non-GAAP売上総利益率を40%台前半から半ばと予想している。
• アウトセットは、今後数年間で3,000台超を対象とする推定1億5,000万ドル規模のコンソール買い替え機会を特定した。既存の医療システム内での導入拡大や新規顧客の獲得も、引き続きコンソール事業の主要な成長原動力となっている。
• 第3四半期の現金使用額は1,030万ドルであり、経営陣は通年の現金使用額が約4,000万ドルとなる見通しに変わりはないと述べた。

主要財務データ

事業および営業実績

コンソール販売は報告された区分の中で最も力強い成長を示した。経営陣は26%増の要因として新規システムと買い替え取引の双方を挙げた。第2四半期に締結されたHCAとの契約はアウトセットにとって初の大規模な買い替え契約であり、受注残の積み上げと売上の可視性向上をもたらした。

同社は、より広範な買い替え需要が3,000台を超え、今後数年間で約1億5,000万ドルの潜在収益に相当すると見積もっている。その他の成長重点項目としては、既存病院へのTabloの追加導入、顧客ネットワーク内のより多くの施設への展開、および同プラットフォーム未導入の病院への販売が挙げられる。

アウトセットによると、推定コンソール導入機会に基づく米国の医療システム上位14グループはすべて既存顧客であるという。また、全米上位100の統合型ヘルスケア提供システム（IDN）の約半数において、1つ以上の施設にTabloが導入されている。商用展開の開始以来、Tabloコンソールを購入した親組織顧客ベースの累積維持率は96%に達している。

EMR売上高は前年同期比で23%増加した。経営陣によると、導入支援およびEMRのアタッチレート向上がサービス・その他売上総利益率の760bp改善に寄与した。Tabloのデータエコシステムは現在10兆件を超えるデータポイントを蓄積しており、同プラットフォームが支援した透析治療件数は累計400万件に達している。

在宅透析において、アウトセットは既存プログラム内の患者数を増やし、Tabloの導入施設を拡大している。経営陣によると、患者基盤の拡大に伴い、導入後初期90日間の在宅患者維持率は90%以上を維持している。

次世代Tabloシステムの準備は継続している。経営陣はスピードよりも顧客体験と発売品質を優先しており、今後数カ月から数四半期にかけて市場への本格投入が進む見通しである。

経営陣のガイダンス

アウトセット・メディカルは2026年通期の業績見通しを以下の通り再確認した。

• 売上高：1億2,500万〜1億3,000万ドル
• Non-GAAP売上総利益率：40%台前半から半ば
• 通年の現金使用額：約4,000万ドル

経営陣は、コンソール売上高の構成比が高まることで、売上総利益率が予想レンジの下限寄りに振れる可能性があると指摘した。売上見通しに対する確信は、営業パイプラインとHCAとの買い替え契約による受注残によって裏付けられている。

同社は2027年の詳細なガイダンスを示さなかった。レニー・ゲータ最高財務責任者（CFO）は、アウトセットが2桁成長への復帰を目指しており、2027年の詳細については第4四半期決算発表時に説明する予定だと述べた。

リスクと注視点

• 買い替え契約の受注残によって可視性が確保されているものの、売上高への転換は流動的な営業パイプラインに一部依存している。
• 製品構成が低採算のコンソールへシフトするため、コンソール売上高の比率上昇が連結売上総利益率を圧迫する可能性がある。
• 米保健福祉省（HHS）の国家腎臓ケア計画（Kidney Care National Plan）の影響は、実際の運用状況に左右される。経営陣は同政策が在宅透析や新技術にとって追い風になり得るとみているものの、最終的な影響は依然として不透明だと述べた。
• 同社が発売品質と顧客体験を優先しているため、次世代Tabloの市場投入は慎重に進められている。
• 経営陣は病院の設備投資環境に大きな変化は見られないとしているが、引き続き積極的なモニタリング姿勢を維持している。

アナリスト質疑応答の要点

アナリストは、在宅透析、次世代Tabloの市場投入、2027年の成長、および病院の設備投資に注目した。

在宅透析について、経営陣は患者向けトレーニングの迅速化・簡素化、導入後初期90日間の維持率90%以上、および既存の医療提供者との関係を通じた拡大を強調した。また、連邦政府の腎臓ケア政策について、実施の詳細次第では追い風となる可能性があると説明した。

急性期ケアについて、経営陣は「老朽化したコンソールの買い替え」「既存顧客内での導入台数および臨床利用の拡大」「新規顧客の獲得」という3本柱の戦略を改めて表明した。潜在的なコンソール需要と治療件数の機会が最も大きいことから、営業資源は全米上位250の大手医療システムに集中されている。

2027年について、経営陣は正式な売上高予想の提示を控えたものの、アウトセットを2桁成長へ復帰させる目標を再確認した。また、顧客との対話において、2027年に向けた設備投資支出に大きな変化は見られないと述べた。

決算説明会トランスクリプト全文

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

Good day, and thank you for standing by. Welcome to Outset Medical's Third Quarter 2026 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Tina Jacobson, Head of Investor Relations. Please go ahead.

Unknown Executive

Good afternoon, everyone, and welcome to Outset Medical's Third Quarter 2026 Earnings Call. Today's speakers are Leslie Trigg, Chair and Chief Executive Officer; and Renee Gaeta, Chief Financial Officer. The company issued a news release after the close of the market today, which can be found in the Investors section of outsetmedical.com.

This call is being recorded and will be archived there as well. All forward-looking statements made during today's call are intended to be protected under the Private Securities Litigation Reform Act of 1995. Outset assumes no obligation to update these statements. For a list and description of the risks and uncertainties associated with the business, please refer to Outset's public filings with the Securities and Exchange Commission, including its latest annual and quarterly reports. I will now turn the call over to Leslie Trigg.

Leslie Trigg

Good afternoon, everyone, and thank you for joining us. Our team executed well in the third quarter, delivering solid progress against our strategic priorities. Just as importantly, we continue doing the foundational work that is strengthening the business and aligning our teams to drive more predictable, profitable growth. I'm confident that these efforts are positioning Outset to capture the significant opportunity ahead. With that, I'll dive right into third quarter results, beginning with financial performance.

Revenue of $33.6 million was up 14% year-over-year and up 6% sequentially. Each of our revenue line items contributed to growth both year-over-year and sequentially. We were particularly encouraged to see console revenue growth of 26% year-over-year, driven by new and refreshed console sales. In terms of recurring revenue, in addition to solid treatment volume, sales of our EMR offering are starting to ramp and grew 23% year-over-year. Ongoing operational initiatives improved non-GAAP gross margin, while expense discipline delivered significant operating expense leverage.

Our clinical excellence team was busy again this quarter with a full lineup of new go-live implementations completed for new customers and existing customers expanding to new locations. Among those were four of the top 10 U.S. health systems. We draw on years of valuable experience to support hospitals as they transition from outsourced to in-source, starting with a detailed project plan customized to each hospital needs, then executing that plan through nurse training, physician education and change management support. All of that requires well-oiled cross-functional execution, and our teams continue to deliver time and again.

Beyond implementation, our clinical excellence team members collaborate with customers to maximize Tablo's system-wide benefits, helping to identify the outcomes that matter most to each organization. Tablo's unique data ecosystem now comprising more than 10 trillion data points enables us to track and trend key performance indicators and regularly share the insights with customers. This ongoing collaboration engages clinical and corporate leaders across our larger health systems, demonstrating value, strengthening customer relationships and creating a foundation for broader system-wide adoption. That level of commitment to delivering measurable benefits is translating into strong customer advocacy.

In our recent voice of the customer assessment conducted by a third-party consulting firm, Outset achieved an overall customer satisfaction score that exceeded all of the consulting firm's health care benchmarks. The results also shed light on what customers value most about Tablo. Survey respondents scored Tablo highly for timely dialysis that improves patient satisfaction, lower infrastructure burden and system costs and simpler dialysis delivery through easier nurse training, mobility and ease of use. These findings validate Tablo's differentiated clinical, economic and operational value proposition and equip our sales team to position Tablo as a platform for system-wide impact.

Additionally, we took an opportunity to analyze our customer retention rate over time. The data revealed that since commercial launch, cumulative retention among parent customers that have purchased Tablo consoles is 96%. We attribute this result not only to our technology, but to the holistic customer experience our team delivers across field service, clinical excellence, data analytics, EMR and many other functions within Outset. Strong customer advocacy and high retention feeds all three of our forward console growth drivers, refresh sales, expansion sales and new customer sales.

Our first significant refresh agreement, which was signed in Q2 with HCA, reinforced one of the nation's largest health systems long-term commitment to Tablo, added meaningful contracted backlog and revenue visibility and validated the refresh opportunity. Our sales team is actively engaged with additional large health systems whose consoles are nearing end of life, and we're encouraged by the progress. We believe we are well positioned to build on this momentum across an estimated $150 million refresh opportunity.

Expansion sales is another of our most compelling growth vectors. Existing customers know our team, understand the implementation process and have firsthand experience with the benefits of in-source dialysis, creating a clear lower friction trajectory from individual site success to system-wide adoption. And we have a great foundation to build on. For example, all 14 of the largest health systems by estimated console opportunity are already existing customers. Additionally, Tablo is already being used in one or more facilities of roughly half of the top 100 largest IDNs. The expansion revenue opportunity is twofold. First, same-store sales growth, which means expanding Tablo's use within a given hospital site, such as moving from Tablo use outside of the ICU to ICU as well or vice versa. Both cases involve the purchase of additional Tablo consoles and incremental treatment volume.

The second expansion opportunity is extending Tablo into new hospital facilities within the health system network. In the third quarter, we closed deals across both of these expansion avenues. Leveraging the deep expertise of our new commercial leadership, we're evolving Outset's commercial model to ensure we are well positioned to execute across all these fronts, refresh, expansion and new customer console sales. For example, we are reducing territory sizes, so our representatives can build deeper relationships aimed at accelerating pipeline conversion. Additionally, we've realigned compensation incentives to ensure they help drive our commercial priorities while investing to reward performance and impact time to productivity.

In parallel, we are expanding our capital sales team regionally and at the national account level to deepen executive level relationships and translate our enviable roster of national contracts into broad system adoption. Across sales, marketing, clinical, service and enterprise accounts, we're working as one outset, aligning our teams around a shared goal, accelerating adoption and driving conversion. This work is underway at a time when the environment for in-person dialysis is becoming increasingly favorable.

Two weeks ago, the Department of Health and Human Services launched the Kidney Care National Plan, which builds on federal dialysis priorities elevated in 2019 by way of an executive order. The national plan calls for greater patient choice, expanded access to home dialysis and initiatives to encourage adoption of new dialysis technologies. It also emphasizes reducing barriers for new dialysis service entrants and aims to address practices that HHS believes limit competition and constrain physicians' ability to offer patients access to a broader range of treatment options and new devices. These priorities are central to Outset's mission to drive fundamental change in how dialysis is delivered.

We're encouraged by HHS' commitment as it aligns with what Tablo was designed to make possible, empowering health systems to bring dialysis in-house while giving patients greater flexibility in where they choose to receive treatment. Over time, changes to market practices and new program initiatives could broaden patient access to home-based care and new home dialysis technologies such as Tablo. While implementation of the national plan will determine its ultimate impact, we view it as a powerful recognition of the need for change and a meaningful step toward a more competitive, innovative dialysis landscape. We believe Outset is well positioned to help lead that change, and we applaud HHS for advancing better care for dialysis patients.

Beyond this new policy tailwind, the macro backdrop for Tablo is attractive. Health systems are under increasing pressure to reduce costs and elevate the quality of care. Dozens of abstracts and papers now validate the clinical and financial benefits of Tablo. We believe there is an exceptionally strong case for bringing dialysis in-house with a simple, data-rich EMR connected platform that gives health systems greater control over a critical service line. Tablo's opportunity to earn market share has never been more compelling. We recognize that we have significant work ahead, but Outset has a strong foundation for scale with the right people and the right technology, and we're excited about what lies ahead. With that, I will turn the call over to Renee.

Renee Gaeta

Thank you, Leslie, and good afternoon, everyone. Total revenue in the third quarter was $33.6 million, up approximately 14% compared to the third quarter of last year. Product revenue was $23.7 million, up 15% compared to last year. Console revenue of $10.5 million grew 26% compared to last year and consumable revenue of $13.2 million was up 8% year-over-year. Service and other revenue was $9.9 million, up 12% year-over-year. Recurring revenue, which includes consumables and service, was $23.1 million, an increase of 10% compared to last year.

Turning next to the P&L. Please refer to the tables in today's earnings release for a reconciliation of GAAP to non-GAAP measures. Third quarter non-GAAP gross margin was 40.8%, up approximately 100 basis points compared to last year and driven primarily by product cost improvements, reduced overhead and service efficiencies. Product gross margin was 44.2%, down 150 basis points compared to last year due to a higher mix of console sales within product revenue. Service and other gross margin was 32.4%, up 760 basis points compared to last year as our attach rates for implementation and EMR software continue to expand. Overall, this performance reflects continued execution and keeps us on track toward our next milestone of a 50% company-wide gross margin.

Moving to operating expenses. We delivered over 300 basis points of operating leverage. Third quarter non-GAAP operating expenses were $24.2 million. Excluding approximately $1 million related to bad debt expense, operating expenses increased only 4% compared to revenue growth of 14%. Non-GAAP net loss was $12.9 million compared to a non-GAAP net loss of $12.4 million in the third quarter of last year.

Moving to the balance sheet. We ended the quarter with $140.7 million in cash, cash equivalents, short-term investments and restricted cash. With ongoing expense discipline and working capital management, cash use was $10.3 million in the third quarter, putting us on track to use approximately $40 million for the full year.

Turning to our guidance for 2026. We are reiterating full year revenue guidance of $125 million to $130 million. We continue to expect full year non-GAAP gross margin to be in the low 40% to mid-40% range with a reminder that a higher mix of console sales could shift gross margin towards the lower end of that range. Our confidence in this outlook is supported by a strong commercial pipeline and contracted backlog related to the HCA refresh agreement. With that, I'll turn the call back over to Leslie.

Leslie Trigg

Thanks, Renee. I want to close by emphasizing the one word that defined this quarter for Outset, execution. Our teams stayed focused on the fundamentals, successfully implementing new sites, expanding Tablo to additional facilities within existing customers, delivering on our first refresh agreement and advancing preparations for next-generation Tablo. We also grew our pipeline through engagement with both existing and new customers. At the same time, we accelerated revenue growth, drove non-GAAP gross margin improvement and delivered significant operating leverage.

Looking forward, we're focused on capitalizing on our three console growth drivers. First, the refresh opportunity, which represents over 3,000 consoles and an estimated $150 million revenue opportunity over the next several years. Second, the expansion opportunity, both same-store sales of additional consoles and new facility expansion. And third, the vast unpenetrated white space of hospitals that have not yet adopted Tablo. To help ensure we are well positioned to execute across all three of these growth drivers, we are expanding our sales reach, strengthening team capabilities and aligning sales compensation to accelerate our inroads into our key commercial focus, the nation's top 250 health systems. Our clinical excellence and customer success teams help customers realize Tablo's full value, creating a foundation to expand from single site relationships to system-wide partnerships.

None of this happens by accident. It is the result of a team that shows up every day with deep expertise and an unwavering commitment to our customers and the patients they serve. I want to thank our employees for the discipline and focus they brought to this quarter, and I want to thank our customers and you, our shareholders, for your continued support. Our end market and the patients we serve need us. Our customers advocate for us because of the considerable measurable value we have created now across 4 million cumulative dialysis treatments.

We are the clear technology leader in a market with increasingly attractive dynamics. The opportunity ahead of Outset has never been more compelling. We have the strategy, the technology and the team in place, and we look forward to sharing our continued progress. With that, we are ready for Q&A. Operator, please open the lines.

Operator

[Operator Instructions] And our first question comes from Josh Jennings of TD Cowen.

質疑応答

Joshua Jennings

This is Colin on for Josh. I guess it seems there have been a lot of interesting developments this year for the home setting. The HHS kidney care plan you mentioned seemingly has a focus there. Vantiv seems to have sold their conventional hemodialysis business, but is refocusing on home. And then we saw data at ASN showing an opportunity to serve a need with peritoneal burnout in the home setting. I was wondering if you could talk about how the home opportunity is evolving for Outset this year in 2026.

Leslie Trigg

Colin, it's Leslie. Thanks for the question. Yes, there have been actually quite a number of interesting developments here just recently. So maybe I'll kind of take those piece by piece. On the HHS front, we'll obviously have to see exactly how it's implemented to understand better how it may change the landscape and more specifically benefit us through encouraging broader home adoption.

But I mean, broadly speaking, we obviously view that as a very positive development. It does renew an earlier federal focus on home dialysis, in particular, acknowledging some areas for improvement, shall we say, around concentration and entry barriers and it may increase or may ease the requirements for setting up new home programs and all of those things could be potentially powerful tailwinds for us. So we'll have to wait and see.

But yes, we do view that as a positive potential policy development that could encourage the adoption of new technologies and more home. There was a lot at ASN this year and last year, actually around home and a lot of, I think, good physician conversation and momentum around broadly how to encourage patients at home and keep more patients at home. And I think this is really where Tablo shines kind of in both actually the front end and the long-term back end. The 2 KPIs that we look at as we're growing our home business are training metrics. And we continue to kind of, I think, lead the industry in how quickly and easily patients and their caregivers can be trained on Tablo to get home. And so that really opens up the aperture, I think, in a really positive way for who can go home and how quickly they can get there.

And then on the back end, our most important KPI is the retention rate. our specific growth strategy is through long-term retention. And even as we have continued to scale home and grow our patient census, we have maintained kind of our industry-leading retention rate of 90% or greater in the first 90 days. And it turns out when you look at the data, it's really that 90-day retention metric that is the most predictive and the greatest leading indicator of long-term retention at home. So we've continued to do very, very well there even as our home population has grown.

And then lastly, I'd say we are growing home and our patient base in two ways. One, we're deepening the depth of the patient census in the facilities and the home programs that already offer Tablo and broad. We are seeing our existing provider customers start to offer Tablo in new facilities and new home programs. So we're excited about that. And we remain focused on our partnerships with the largest, called MDOs, midsized dialysis operators in the country.

So a lot to say. I'm happy to take another question about home Colin, if you have it. But I think all of these developments point potentially more to be revealed, potentially do point to some upsides and some tailwinds in the future here with regard to home.

Joshua Jennings

Amazing. And I guess my second question would be a little bit more about the acute setting with the rollout of the next-gen system. I'm just curious how that's progressing and how the feedback has been now that we're a little further into launch. Sure. Well, yes, let me kind of take a step back and talk about acute more broadly. So our big picture commercial strategy around acute is really threefold.

Leslie Trigg

As I just mentioned in the prepared remarks, one is the refresh opportunity. The second is expansion with current customers, which takes 2 forms, both same-store sales growth, adding new consoles and expanding the clinical use of Tablo in a given hospital setting. And then lastly, of course, new customer acquisition. And we see all three of those opportunities resident in our focus on the top 250 largest IDNs in the country. And why are we focused on the largest 250? Those institutions, frankly, have the largest potential console TAM and also treatment volume TAM. And so that's where our commercialization organization has redoubled their focus and their energies.

The next generation, to get to your question there, we are continuing to kind of advance through preparations for a full release. We are certainly continuing to prioritize a high-quality customer experience over speed. And fortunately, we have the luxury of ensuring that we get it right. We feel really good about the way that it's developing, but we do want to make sure that the customer experience, especially now that we're operating at a fairly substantial scale with regard to the console installed base and our customer installed base that we're really doing this and getting it right from the get-go. So we're going to continue to progress through that and look forward to seeing it in the market at scale here in the coming months and quarters.

Operator

Our next question comes from Kendall Au of RBC Capital Markets.

Kendall Au

Congrats on the quarter. First, I just want to ask, I know you guys reiterated your guidance on the top line. I was wondering why you didn't want to raise the low end or change guidance after the of the quarter? And also, do you have any like comments on '27? What's a good starting point for revenue next year? Do you think a 10% growth year-over-year is achievable? Would love to hear any comments on that, too.

Renee Gaeta

Kendall, it's Renee. Thanks for the question. I think really good questions and things that are, of course, top of mind for us. 2026 is an important year for us with execution. We said that from the beginning of the year, and we've been holding strong to that every single quarter, we are focused on maintaining that discipline around our guidance strategy and execution against it being top of mind. Our pipeline is dynamic and staying within that sort of disciplined guidance methodology.

We just want to make sure that we set ourselves up for success and decided that standing here today with reporting of Q3, we are where we expected to be. We're really happy with the performance for this year. And as you see even in all of the models that are out there, the back half of 2026 does already have pretty significant growth rates built into it. And so we're comfortable with leaving it there for now. And we look forward to talking about 2027 in finer detail when we report Q4. What I can say is, of course, we want to return to a double-digit growth company, and this organization is definitely focused on the ability to execute against that.

Kendall Au

Yes, I appreciate that. And then one quick question also on top of that. Do you see any major changes in the CapEx environment heading into '27? Do you like expectations of like maybe a slowdown? Or do you think consistent on the spending pattern for next year? Just love to hear any comments on that.

Leslie Trigg

Yes. Kendall, this is Leslie. We have not to date. Obviously, subject to change, and we're all out there on the capital equipment front, obviously, in active monitoring mode. But based on what we've experienced and what we're hearing and discussing with customers, we're not seeing or perceiving any big changes in the capital spending climate at this time.

Operator

I see no further questions at this time. I'd like to turn it back to Leslie Trigg for closing remarks.

Leslie Trigg

Great. Well, thanks to all of you for joining today. I'd like to close by thanking our customers and our team for the difference they make in the lives of dialysis patients every day. Have a great afternoon and evening.

Operator

Thank you. This concludes today's conference call. Thank you for participating, and you may now disconnect.