Mobia Medical (MOBI) 2026年第3四半期決算説明会：売上高73%増、ガイダンス引き上げ

重要ポイント

• 2026年第3四半期の売上高は、Vivistimの導入拡大と約425台の販売に支えられ、前年同期比73%増の1,560万ドルとなりました。
• 成長の大部分は既存顧客が牽引した一方、平均アクティブ担当地域数は前年同期の22.5から78%増の40に拡大しました。
• 粗利益率は、主に運賃や関税コストの低下、および在庫評価損の減少により、前年同期の79.6%から83.2%に改善しました。
• モビア・メディカルが営業体制への投資を継続したため、営業費用は3,150万ドルに増加し、純損失は1,730万ドルに拡大しました。
• 経営陣は2026年通期の売上高ガイダンスを従来の5,400万〜5,600万ドルから5,700万〜5,750万ドルに引き上げ、年間成長率は約78%〜79%となる見通しを示しました。
• 2026年9月30日時点の現金および現金同等物は総額1億6,070万ドルとなりました。

主要財務データ

事業および営業実績

Vivistimは引き続き主要な成長ドライバーとなりました。FDA（米食品医薬品局）の承認を受けた同機器は、中等度から重度の上肢障害を有する慢性期虚血性脳卒中の対象患者向けに開発されています。モビア・メディカルによると、販売台数の増加は新規および既存のVivistimプログラム双方での導入拡大を反映したものであり、当四半期の成長には既存顧客が大部分を占める貢献をしました。

同社は、テリトリーマネージャーが少なくとも9カ月間配置されている地域を「アクティブな担当地域」と定義しています。モビア・メディカルは、着実かつ一貫したペースで担当地域の拡大を継続する計画です。同社の商業モデルは、テリトリーマネージャーとセラピー開発スペシャリストを連携させ、病院プログラムや紹介経路、地域のリハビリ施設との関係を構築するものです。

経営陣は、8月に改定された米国心臓協会（AHA）および米国脳卒中協会（ASA）の脳卒中回復ガイドラインに、リハビリと併用する迷走神経刺激療法が掲載された点を強調しました。同社はこの評価により医師の関与が高まっていると述べ、計画していた単一病院での導入を、より広範な統合型医療提供ネットワーク（IDN）での展開へと拡大した病院グループの事例を挙げました。

保険償還は引き続き戦略の重要な要素です。Vivistimはカテゴリー1のCPTコードを有しており、メディケアの平均支払額は約4万5,000ドルに達します。また経営陣は、最近の病院外来診療報酬制度（OPPS）の最終規則が現行の保険償還戦略の継続を後押ししていると述べました。

モビア・メディカルは、米国の対応可能市場（SAM）を300億ドル超と見積もっています。同社は2027年中にGRASPレジストリの第1弾を公表する予定であり、既存の臨床データを補完するリアルワールドエビデンスを提供する見通しです。

業績予想（ガイダンス）

経営陣は、2026年通期の売上高ガイダンスを従来の5,400万〜5,600万ドルから5,700万〜5,750万ドルに引き上げました。改定後の見通しは、2025年比で約78%〜79%の成長を見込んでいることを示しています。

この見通しは、米国内での担当地域の継続的な拡大、患者ファネルの持続性、ならびに病院によるVivistimプログラムの導入および投資の勢いに基づいています。

経営陣は、粗利益率が80%台前半で推移すると予想しています。テリトリーマネージャー、セラピー開発スペシャリスト、事前保険承認対応、患者向け啓発活動など、商業展開への投資が引き続き最大の支出優先事項となります。

リスクと注目点

• 第3四半期の営業費用は売上高を上回るペースで増加しており、継続的な人材採用や商業インフラへの投資を反映しています。
• 増収および粗利益率の拡大にもかかわらず、純損失は前年同期の1,140万ドルから1,730万ドルに拡大しました。
• 新規担当地域については、同社がアクティブ地域として分類するまでに約9カ月の投資期間を要します。
• 経営陣は、保険適用範囲のさらなる拡大は、十分に成熟したリアルワールドエビデンスや支払済み保険請求件数など、複数の要因に左右されると述べました。
• 同社は市場開拓の初期段階にとどまっており、地域拡大と生産性向上による詳細な内訳は公表しませんでした。

アナリスト質疑応答の要点

• 売上高の牽引要因：経営陣は第3四半期の成長を営業の実行力によるものとし、増加分の大部分を既存顧客が生み出したと説明しました。
• 担当地域の拡大：同社は一貫したペースで担当地域の拡大を継続する方針ですが、四半期ごとの具体的な目標は示しませんでした。
• 成熟地域の生産性：経営陣は長期的な視点では病院での取扱件数が増加すると見込んでいるものの、商業展開はまだ初期段階にあり、成熟曲線を数値化するには時期尚早であると述べました。
• 臨床エビデンス：GRASPレジストリの第1報は2027年中に公表される予定です。経営陣は、リアルワールドエビデンスを医師の採用や将来的な保険適用の拡大を支える要素の一つと位置付けています。
• 資本配分：営業部門の採用、事前保険承認のサポート体制、患者向け啓発活動が、引き続き主要な投資優先事項となります。

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

I would now like to turn the call over to Louisa Smith of Gilmartin Group Investor Relations for Mobia Medical. Louisa, please go ahead. Thank you.

Louisa Smith

Good afternoon, and thank you for being on today's call. Joining me from Mobia Medical are Richard Foust, President and Chief Executive Officer, and Bunker Curnes, Chief Financial Officer. Earlier today, Mobia Medical issued a press release announcing financial results for the quarter ended September 30, 2026. A copy of the press release is available on the Investor Relations section of the company's website.

Before we begin, I would like to remind you that management will make remarks during this call that constitute forward-looking statements within the meaning of the federal securities laws and that are being made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that relate to expectations or predictions of future events, results, or performance, including our full year 2026 revenue guidance, are forward-looking statements. These statements involve material risks and uncertainties that could cause actual results or events to differ materially from those anticipated or implied by these forward-looking statements.

Accordingly, you should not place undue reliance on these statements. For a full list and description of the risks and uncertainties associated with our business, please refer to the section captioned Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations in our filings with the Securities and Exchange Commission. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 5, 2026. Mobia Medical disclaims any intention or obligation, except as required by law, to update or revise any forward-looking statements, whether because of new information, future events, or otherwise. With that, I will now turn the call over to Richard.

Richard Foust

Thank you, Louisa. Good afternoon, everyone, and thank you for joining us today. We are pleased to welcome you to Mobia Medical's Q3 2026 earnings call and are eager to share some details behind our strong third quarter performance.

But first, we will begin with a real patient story that grounds us in why we do this work. Bill was 52 at the height of his career and in excellent physical condition when he suffered an ischemic stroke after his daily run. He lost nearly all function in his right arm and hand that day. Over the next 3 months, he underwent intensive physical therapy, but his arm remained immobile. Because the hospital where Bill was treated was a Vivistim center, his care team brought him back for evaluation once his recovery plateaued. And he began Vivistim therapy 6 months after his stroke.

After just 6 weeks of Vivistim therapy, he had made more progress than in the previous 6 months. He is now dressing independently, tying his shoes with both hands, and preparing meals. That was in 2022. And today, there is nothing he cannot do independently. Bill's story shows what is possible with Vivistim therapy. And his story is not an outlier. Every day, we hear from enthusiastic patients whose lives have been changed with Vivistim therapy. These patient stories are why we are so committed to this mission, and this quarter's results show that our work is paying off.

Let me take you through our Q3 results and outlook for the rest of 2026. Revenue totaled $15.6 million for the quarter, representing a 73% growth over the prior year. With this performance and the strong fundamentals of the business, we are raising our full-year revenue guidance. We now expect total 2026 revenue in the range of $57.0 million to $57.5 million, up from our prior guidance of $54 million to $56 million. Bunker will cover additional financial details and guidance assumptions later in our remarks.

This quarter's performance reflects the strong fundamentals of our business. We address a large unmet need with a clinically validated solution that is generating patient demand, backed by strong market access and a favorable financial profile. Let me take a moment to discuss each of those elements. First, we are addressing a compelling unmet need for a highly motivated patient population that is symptomatic. There are approximately 9 million ischemic stroke survivors in the United States, many living with lasting impairments in their arms and hands. And until Vivistim therapy, there were no proven options once their recovery plateaued.

This is why patients and healthcare providers are eager to adopt Vivistim therapy, the first and only clinically validated, FDA-approved device for chronic ischemic stroke survivors with moderate to severe upper extremity impairments. And most importantly, we have successfully treated patients several decades after their strokes. With Vivistim therapy, there is no expiration date on recovery. Second, Vivistim therapy is backed by strong and growing clinical evidence and physician support. Our published clinical data demonstrates meaningful clinical improvement, durability through 2 years, and reproducibility in real-world settings.

This evidence, alongside growing adoption, is driving increased awareness in the physician community. In August, we were pleased to announce that the American Heart Association and American Stroke Association revised their stroke recovery guidelines to include paired vagus nerve stimulation as a treatment option for improving upper limb function for eligible chronic stroke survivors. Recognition of Vivistim therapy by one of the most influential professional organizations in our space is a huge testament to the quality of our clinical evidence and the profound impact of our patient outcomes.

As we continue to collect and publish real-world data, we believe that similar recognition from additional professional societies will follow, and that this will serve as a key building block in establishing broad utilization and payer coverage across the country. Third, we continue to be well positioned on reimbursement with a well-established Category 1 CPT code associated with an average Medicare payment rate of approximately $45,000 and a highly effective in-house prior authorization and market access team.

Vivistim therapy is accessible to patients, and hospitals are getting paid for performing the procedure. With a large serviceable market, which we estimate to be over $30 billion in the U.S. alone, a highly valued product, and a gross margin above 80%, we have all the ingredients for a sustainable, high-growth business that can create operating leverage at scale. We have a unique opportunity in front of us. Our commercial engine is optimized to capture it effectively through a thoughtful process of building new territories, launching Vivistim programs, and engaging patients in the stroke ecosystem.

I'm going to dive a little bit deeper into the specifics of what this market build looks like. Our field team is organized into territories, each with a territory manager or TM and a therapy development specialist or TDS. TMs are responsible for partnering with hospitals and healthcare providers, while TDSs partner with therapy sites and support patient education in the community. TMs focus on engaging with stroke hospitals. Stroke hospitals have the expertise and infrastructure to lead the way in defining new standards of care for chronic stroke recovery.

They are the center of the stroke care ecosystem with connections to occupational and physical therapy sites in the community that enable the continuity of care beyond acute survival and into chronic recovery. We estimate there is a relatively concentrated base of approximately 1,500 primary and comprehensive stroke centers across the United States. At each stroke hospital, our TMs build relationships with the entire stroke care team, including neurosurgeons, neurologists, physiatrists, and stroke coordinators.

Our TMs learn how acute stroke care currently works at each site and then determine how Vivistim programs can fit in so that the hospital has a comprehensive chronic stroke recovery pathway. In concert, our TDSs work with the stroke care ecosystem outside of the hospital, such as therapy sites and patient support groups, to drive awareness and referrals. Our TDSs also onboard the therapy sites around the stroke hospital that will deliver in-clinic therapy to Vivistim patients and partner with these sites to ensure care continuity and successful patient outcomes.

Putting that together, each new Vivistim program we open is a stroke hospital that will screen and implant patients with connections to the therapy sites that will identify eligible patients and provide in-clinic Vivistim therapy after implant. This is what constitutes a high-quality, sustainable Vivistim program. Importantly, we are not disrupting existing care pathways. Rather, we are extending the treatment continuum beyond the acute and subacute phases. Through this process, we are creating advocates for Vivistim therapy, not just creating users of our technology.

Our third quarter reflects continued success in building the market for Vivistim therapy, increased awareness and recognition among the physician community, Vivistim programs built with care and attention, and more patients experiencing new possibilities in their recovery journey. Whether they are returning to their favorite hobby, picking up their grandchild again, or cooking a meal on their own, our patients continue regaining independence that was once out of their reach. That is Mobia's why, and we are just getting started. With that, I will turn the call over to Bunker to review our third quarter financial results. Bunker?

Nelson Curnes

Thank you, Richard, and good afternoon, everyone. Total revenue for the third quarter of 2026 was $15.6 million, representing year-over-year growth of 73% compared to $9 million in the third quarter of 2025. We sold approximately 425 units in the quarter. This growth was driven by the broader adoption of Vivistim therapy at both new and existing programs, leading to higher unit sales. Revenue came in ahead of our expectations, driven primarily by success in our existing programs.

Our patient funnel continues to create consistent, predictable revenue for our business, and with a massive TAM still ahead of us, we are excited about our trajectory going forward. As a reminder, we define an active territory as one that has had a territory manager in role for at least 9 months. In the third quarter, we expanded our footprint to 40 average active territories, an increase of 78% over the 22.5 average active territories in the same period last year. We anticipate continuing to add new territories at a relatively consistent pace.

Our gross margin was 83.2% for the third quarter of 2026, compared to 79.6% in the third quarter of 2025. The increase in gross margin was primarily due to lower freight and tariff costs, recognized in cost of goods sold as a percent of sales, as well as lower inventory write-offs compared to the prior-year period. As expected, our per-unit product costs remained relatively consistent this quarter, and we continue to expect gross margin to remain in the low 80s moving forward.

Total operating expenses for the quarter were $31.5 million versus $18.4 million in the prior-year period. The increase in OPEX spending is primarily due to an increase in personnel-related expenses driven by headcount, particularly within our commercial organization, as well as $2.2 million in additional stock-based compensation expense. We continue to invest in our commercial organization and the infrastructure needed to support growth while remaining focused on improving operating leverage over time.

Net loss was $17.3 million, or $0.52 per share, in the third quarter of 2026, compared to a net loss of $11.4 million, or $13.31 per share, in the third quarter of 2025. Year-over-year improvement in net loss per share primarily reflects the significant increase in common shares outstanding following the company's May 2026 IPO and the related conversion of outstanding convertible preferred stock and convertible notes into common stock.

Turning to the balance sheet, cash and cash equivalents as of September 30, 2026 were $160.7 million. Looking ahead to the remainder of 2026, we are raising our revenue guidance and now expect total revenue to be in the range of $57 million to $57.5 million, representing growth of approximately 78% to 79% over the full year 2025, compared to our prior guidance of $54 million to $56 million.

This outlook reflects our continued confidence in our commercial strategy, including our expansion of sales territories across the U.S., the durability of our patient funnel, and momentum from hospitals activating and investing in their Vivistim programs. With that, I will turn the call back to Richard for a few closing comments.

Richard Foust

Thanks, Bunker. We continue to be enthusiastic about the opportunity ahead of us. We are addressing a significant unmet need with a first-of-its-kind therapy that is backed by robust clinical evidence and growing recognition in the physician community. Our business has the key elements for significant impact and scalable growth. Our team is demonstrating excellence every day and executing in service of this important mission.

We are inspired by healthcare providers, therapists, patients, and caregivers that we partner with every day. And we won't stop until Vivistim therapy is the standard of care for stroke recovery. With that, I will turn the call over to the operator for Q&A. Thank you.

Operator

[Operator Instructions]

Our first question comes from Travis Steed from BofA.

質疑応答

Travis Steed

Hey, congrats on the good quarter. I'll ask both my questions up front to keep it efficient. The first question, just maybe touch on the quarter beat raise. It looks like you're raising by the beat to all kind of make sense. I know there's any color you'd like to give on the outlook, what's assumed on utilization. And then the follow-up question I'll go ahead and get out of the way is on the new tech APC code in the final rule. I assume gives more confidence around reimbursement next year. So what's the process to get the level 6 code look like from here and any updates to the timeline? Thanks a lot.

Richard Foust

Travis, this is Richard. Thank you for the question. I'll start by saying that Q3 was a really strong quarter, great execution, doing what we need to do to grow the, you know, the number of active territories that we have, as well as driving adoption. As you know, we have a large market, compelling unmet need, great clinical and patient outcomes with physician support, and we're well positioned with our reimbursement and patient access situation right now. You know, 73% growth year-over-year is a very strong showing.

When we think about what drove that overage, I would put it down to strong commercial execution and really, really more growth coming from existing customers, which, as you know, is really healthy. In terms of the guide, we feel really confident with the guide. It's also, we have very disciplined and thoughtful approach. And so we're very comfortable with a 78% to 79% growth year over year with all the momentum that we have coming from Q3.

Lastly, in regards to your question about the OPPS ruling that just recently dropped, thank you for the question. It sets us up exactly as you said, which all of the things that we thought would happen are going to happen. And so we can roll forward our strategy that is working today and growing the company. So we're highly confident and excited about that outcome.

Operator

Our next question comes from Robbie Marcus from JPM.

Robert Marcus

Oh, great. I'll offer congratulations as well on a nice quarter. Now that reimbursement continues to improve and certainty improves, maybe speak to the reception you're getting out in the field. You know, what's the sales team doing to continue to bring in new accounts and drive utilization, and, you know, just speak to the receptivity in the field? Thanks.

Richard Foust

Yes, Robbie, this is Richard. It's a very good question. And I would say, I'm going to start by the building blocks of kind of what we are putting together to build, you know, a brand new market in stroke recovery. It starts with having this refined and disciplined approach commercially, which we continue to be able to execute against. And then these other building blocks, which are unlocks for us.

We recently published 2-year clinical outcomes, which reinforces the sustainability of our technology, as well as most recently being included in the AHA guidelines. And all of those things, you know, lead to further engagement. And I would say physicians leaning into our story. You know, specifically when I think about the AHA guidelines, it is a validation for patients and for physicians to really pay attention to us at an even higher level.

And the example that I'll give for you, just to put it into plain terms, you know, we were working on a hospital that was part of a larger IDN. And after the guidelines came out, you know, that hospital system reevaluated and decided to make it a full IDN implementation. And so I think in a lot of ways, you know, the unlock and the validation that we're getting as we move forward and begin to make this progress is all of the natural part of inflection points that we will have as a business, but it's really just an important segue to grow and developing and driving awareness.

Robert Marcus

Great. And maybe as a follow-up, speak to where you're spending your money and investing. What are the priorities, and how should we expect that to continue going forward? Appreciate it.

Richard Foust

Yes, thank you. The priorities today remain the same. We are investing in a commercial organization and the flywheel of all the things that we've built over the last number of years. This is hiring territory managers and TDSs, investing in our prior auth team and all of the patient education that goes with that. So that is where most of our investment is going. Bunker, would you like to add any comments to that?

Nelson Curnes

Well, just to say that, as we said during the scripted remarks, a territory manager that we hire really becomes an active territory for us after approximately 9 months. And that 9 months is our commitment and investment into that commercial territory to help ensure that they can drive the correct growth and outlook for those different areas. So we really are focused on spending the majority of our spend in the commercial organization, and we feel like that is the correct strategy for us going forward.

Operator

Our next question comes from Ryan Zimmerman from BTIG.

Ryan Zimmerman

Hi, this is Jacqueline on for Ryan. Thank you for taking the questions. For active territories coming in at 40 in the third quarter, implying 4.5 net adds in the quarter, on the second quarter call it was mentioned that 4 to 5 adds per quarter was a comfortable range. Does that still hold true for the fourth quarter or does the trajectory heading into '27 look different?

Nelson Curnes

Yes, thank you. I would say that the pace of new hires and new adds continues to be measured and consistent. It's really how we think about the business, making sure that we're set up for success on a continuous basis and we have the right people in place so that when they do become an active territory, they can really help to drive the revenues forward. While we don't necessarily guide to specific numbers, I think you've seen our territory adds over the last several quarters, and we intend to maintain a consistent pace moving forward.

Ryan Zimmerman

Thank you. And with revenue coming in at $15.6 million, up 73% year-over-year, can you walk us through how much of the growth was territory driven versus improving productivity in existing?

Richard Foust

Yes, I would say to answer that question, we don't really give a breakout on that specific metric. But what I can say is disproportionately more the growth came from existing customers.

Nelson Curnes

Yes, the productivity of those individual territories, as Richard said, is not necessarily something that we direct to, but that consistent growth of the active territories and those territories continuing to act, again, consistently. They're performing well. The rinse-wash-repeat of the next territory in is continuing to deliver those results, and so we see a lot of good signs for the future.

Operator

Our next question comes from Drew Curtis from Wolfe Research.

Michael Polark

Hey guys, this is Drew on for Mike. Kind of building off the last question, as your commercial organization continues to scale, is there any change to how long it takes the new territory to become productive? And then for the more mature territories, are you starting to see higher unit volumes there?

Richard Foust

Yes, so I'll take this. So two things. One is, I think over a long horizon, obviously, you know, the volume that a hospital does will increase over time. We're not in a position yet, since we're so early in our build, to talk specifically about what that looks like. In terms of how things mature, there's so much room in front of us. We're talking about a TAM of $30 billion, and within a territory, as you know, what we are doing is activating patients, and where patients go to get their procedure done is sometimes dependent on what is most convenient for them.

And so that's really why we talk about a territory approach, but we do expect over a longer time horizon, as we build this out across the country, for us to continue to drive adoption. And so that is our plan. I would say just in where we are today, we're still in the process of building and developing.

Nelson Curnes

Yes, I think it's about driving the continued awareness in the territories, which is awareness of our future patients, it's awareness of our physicians, it's awareness of those referral pathways. And we're still at the early days of that process, but we're starting to see some real momentum build.

Michael Polark

And then I guess on the clinical evidence piece, you're continuing to generate data for Vivistim. Broadly, what's the next major data milestone on the horizon, and how do you see this potentially influencing payer coverage and more physician adoption?

Richard Foust

Yeah, I would say, you know, we expect in, you know, within 2027 to be able to publish our GRASP registry or the first part of our GRASP registry. And that will be something that is, I think, an important milestone in terms of really being able to be the first real-world evidence that we have published. Obviously, there's other single-center studies out there. And in some ways, will enable, you know, physicians, societies, and others to see how our real-world evidence compares to, you know, our very credible Lancet publication with triple-blinded, randomized, sham-controlled study.

Michael Polark

Yes, just how that would potentially drive more payer coverage and physician adoption. Yes.

Richard Foust

Yes, I would say on the payer coverage, there's a lot of elements to payer coverage. I would say definitely real-world evidence is one of those elements, but I think it's not just the publishing of the data. It's a large enough amount of patients at the right time point. And then the second part of payer coverage is really the number of paid claims. And so there's a lot of different elements that have to line up for any specific payer before that would occur.

Operator

This concludes the question and answer session. I would now like to turn it back to Richard Foust for closing remarks.

Richard Foust

Thank you all for your interest in Mobia Medical. As we close out today's call, I want to reiterate that, you know, this is what motivates our team every day. With Vivistim, stroke survivors are able to regain something that they thought was gone forever. The need is still far greater than the number of patients we reach today, and we are just getting started in changing the standard of care. We're proud of the progress this quarter, and we're even more excited about what's ahead. Thank you. Thank you for joining us.

Operator

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

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