Mobia Medical, Inc. Common Stock 2026 Q2 Earnings Call

Louisa, please go ahead. 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 June 30th, 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 sections 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, August 11th, 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.

Thank you, Louisa. Good afternoon, everyone, and thank you for joining us today. We are pleased to welcome you to Mobia Medical's first earnings call as a public company. In May, we successfully completed our initial public offering, raising $134 million in net proceeds with strong support from top-tier investors who share our vision for the future of stroke care. This successful IPO marks an important milestone for Mobia Medical by strengthening our balance sheet and providing the capital needed to accelerate commercialization, patient access, and support the next phase of our growth. At Mobia, we put patients first. Before we move to our quarterly remarks, and as will be our precedence going forward, we are going to start with a patient story that brings to light the why that drives our team every day.

I would like to introduce you to Tess, who suffered a stroke 10 years ago and had accepted that she would never regain meaningful use of her dominant hand. Her greatest hope was simply to care for her children more independently. More importantly, but seemingly out of reach, she would love to hold her children in her arms. After completing Vivistim Therapy, Tess reached and achieved something she never thought possible. She picked up her young son with both arms for the first time since her stroke. That was an amazing moment for her.

Today, she continues to reach new milestones, serves as a Vivistim ambassador, and inspires other stroke survivors with a simple message: "I wish I could show you just how different it will be." For Mobia Medical, Tess's accomplishments are a living testimony of our mission to help stroke survivors regain independence and reclaim parts of their lives they thought were lost forever. This is our why. We mobilize breakthrough possibilities for chronic stroke survivors. Now that you have some context for the amazing things we are doing for patients, let's move to our quarterly results. We delivered a strong second quarter with financial performance reflecting continued commercial adoption of our Vivistim paired VNS therapy for upper extremity impairment in chronic ischemic stroke survivors. Revenue totaled $13.5 million, representing a 102% growth over the prior year, and gross margin for the second quarter was 83.2%.

We are pleased with our execution in the first half of the year and encouraged by the momentum entering the second half of the year. We are initiating revenue guidance of $54 million-$56 million for the full year of 2026, which represents a growth of 69%-75% over the prior year. Bunker will cover the financial details later in our prepared remarks. First, I'd like to provide an overview of Mobia Medical for those of you who may be newer to our story. Mobia Medical is focused on redefining stroke recovery. Over the past few decades, stroke care has largely been focused on acute survival. There have been many meaningful advancements in acute stroke protocols and interventions such as tPA and thrombectomy. As a result, millions more people are surviving their strokes. That has created a large and underserved population of chronic stroke survivors.

There are approximately 9 million ischemic stroke survivors in the U.S. today, a large portion of who are living with chronic life-altering motor impairments, particularly in their arm and hand. Most of these patients undergo physical or occupational therapy in the first months following their stroke, but many will experience a plateau in improvement after the first three to six months. After that, they have historically been very few options to improve their upper limb function, and they are left to live with impairment for the rest of their lives. Our mission is to change that paradigm. Vivistim Therapy is the first and only FDA-approved, clinically validated solution for chronic ischemic stroke survivors with moderate to severe upper limb impairment. The Vivistim System includes an implanted pulse generator and lead that delivers stimulation to the vagus nerve when activated during upper limb exercises.

This paired VNS therapy boosts neuroplasticity and enables the brain to create new neural connections and remodel motor pathways that were damaged by the stroke. The meaningful and durable benefits of Vivistim Therapy were proven in our VNS-REHAB pivotal study. This was a randomized, triple-blinded, sham-controlled trial originally published in The Lancet in 2021, demonstrating that patients who received active Vivistim Therapy had 2 to 3 times greater improvement in upper limb function compared to patients who underwent sham therapy with results out to 2 years. Importantly, this study included patients who were 9 months to 10 years post-stroke, demonstrating that the results of Vivistim Therapy are independent of time post-stroke. With Vivistim, there is no expiration date on recovery, and we have effectively raised the ceiling of possibility on a stroke survivor's recovery journey. Commercially, we have even successfully treated survivors up to 45 years post-stroke.

Across our clinical studies and commercial experience, the increase in motor improvement enabled by Vivistim Therapy has translated to meaningful functional benefits for patients. Some patients have regained the ability to get dressed independently, feed themselves, drive a car, or even return to work. Vivistim Therapy has been life-altering for many stroke survivors. We have continued to further the evidence associated with Vivistim Therapy. In July, we announced the publication of 2-year follow-up data from our pivotal trial in Neurology, the official peer-reviewed journal of the American Academy of Neurology, demonstrating the durability of improvement achieved with Vivistim Therapy. Participants maintained statistically significant and clinically meaningful gains for at least 2 years after treatment. A subset of patients who had been followed out to 3 years also demonstrated similarly durable outcomes, underscoring the lasting impact of our therapy.

The study also captured data indicating that upper limb motor improvements translated into impactful real-world changes in the daily lives of stroke survivors, as reflected across several patient-reported measures of quality of life. Additionally, a separate subset of participants demonstrated further improvement between 1 to 2 years, suggesting recovery can continue over time with ongoing self-directed Vivistim Therapy. Because Vivistim can be effective no matter the time elapsed since stroke, we are able to serve the immense existing prevalence population, as well as the hundreds of thousands of people who suffer an ischemic stroke each year. Stroke is one of the leading causes of long-term disability in the U.S., and we estimate that our serviceable market in the U.S. alone is worth over $30 billion. This figure is representative of patients who are on-label and strong candidates for Vivistim Therapy.

Given the significant opportunity within our current approved indication, we are focused on expanding access to this large market that we have approval for today. Our commercial model is purpose-built around the unique dynamics of the stroke market. We are targeting stroke centers because they have a strategic focus on delivering high-quality stroke care, and they have the expertise and infrastructure to lead the way in defining new standards of stroke recovery care. There are approximately 1,500 primary and comprehensive stroke centers in the U.S., which is a concentrated and specialized group. In addition, the surrounding infrastructure network of these stroke hospitals provides access to both acute stroke patients entering the care pathway, as well as the larger population of stroke survivors already in ongoing recovery. To date, we have seen sustained interest from leading stroke centers across the country, while healthcare providers are championing our technology for patients.

Our field team is split into territories, each consisting of a Territory Manager and at least one Therapy Development Specialist. Territory Managers are responsible for hospital logistics, healthcare professional relationships, and the support and creation of Vivistim program infrastructure. The Therapy Development Specialist, who is typically a licensed occupational or physical therapist, manages education and relationships within the ecosystem of stroke therapists, therapy sites, and is responsible for establishing a community support structure that drives awareness and identification of Vivistim Therapy candidates. These two roles are complementary by design to support the full patient journey from identification through therapy. We are excited about the progress that this sales unit has shown in effectively initiating and growing territories. As we build the stroke recovery market, our growth and commercial success will be driven by several interconnected priorities, all oriented around broadening access and awareness for Vivistim Therapy.