Solana Company

Good day, and thank you for standing by. Welcome to the Helios Medical Technologies Inc. Quarter 1 2023 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michelle Bilski of Insight Communications. The line is now yours.

Thank you, Gerald. Welcome to the first quarter 2023 earnings conference call for Helios Medical Technologies. This is Michelle Bilski of Insight Communications, investor relations for Helios. With me on today's call are Dane Andree, Helios Medical's president and chief executive officer, and Jeff Matieson, chief financial officer. At this time, all participants have been placed in a listen-only mode. Please note that this call is being recorded and access to the webcast can be obtained through the investor section of the Hewleus website at www.hewleusmedical.com. Before we begin, I would like to remind everyone that our remarks and responses to your questions today may contain forward-looking statements that are based on the current expectations of management. These forward-looking statements involve inherent risks and uncertainties that can cause actual results to differ materially from those indicated. including those identified in the risk factor section of our most recent annual report on Form 10-K and quarterly reports on Form 10-Q. Such factors may be updated from time to time in our other filings, which are available on our website. All statements made during this call are as of May 11, 2023. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events, or otherwise, except as required by law. I would now like to send the call over to Dave Andrews, President and Chief Executive Officer of Helios.

Thank you, Michelle. Welcome, everyone, to Helios Medical's first quarter 2023 earnings conference call. PONS therapy has been commercially available in the United States for one year, and in that time, we've seen a steady increase in the number of Americans who've used PONS to treat balance and gait impairment due to multiple sclerosis, as well as in the number of registered PONS therapists and physicians who have introduced PONS into their day-to-day practice. The rollout continues, and we've consistently seen new inquiries each week. PONS is the only portable and readily accessible neuro-STEM therapy with the potential to generate neuroplasticity, which makes PONS therapy a game changer for those affected by MS. Pons devices are currently on a cash pay basis with a U.S. cash price of $14,500, discounted substantially from our list price of $25,700, which is comprised of a one-time cost of $17,800 for the controller plus $7,900 for the mouse piece. As mentioned in last quarter's call, sales can be difficult to predict and are subject to quarterly fluctuations. Our first quarter revenue came in below expectations due to a combination of these timing differences, as well as some cannibalization by our therapeutic experience program, otherwise known as PONSTEP, at certain sites, and the short-term impact of refining our processes as we transition to e-commerce. With that said, we are excited about the potential of pawns to continue gaining traction in the U.S., and our outlook for the year remains unchanged. We project 2023 revenue to exceed 2022, even as pawn sales in the U.S. are expected to remain on a cash pay basis throughout the remainder of the year. We believe broad third party payer reimbursement is needed to achieve our full revenue potential. And we are pleased with the progress we're seeing with the transitional coverage of emerging technology or the TCEP program, which is CMS's proposed accelerated coverage pathway for new and innovative medical devices. In March, a bipartisan breakthrough designation device bill was reintroduced to Congress and the OMB, which would allow companies with a breakthrough designation to be covered by Medicare for four years. POND has breakthrough designations in both MS and stroke in the U.S., and we are closely monitoring this legislation. While we actively pursue coverage, we are pleased to offer a patient therapy access program, or PTAP, so that the cost doesn't have to be a barrier to treatment. In January, we announced the extension of PTAP through June of 2023, whereby qualifying patients can purchase on-label PONS therapy at an 85% discount to list price. We want as many qualifying patients as possible to benefit from PONS therapy, and cost is just one impediment we are trying to help patients overcome. For those suffering walking challenges, simply leaving the house can be a daunting task. To bring PONS literally closer to the home, we recently launched PONStherapy.com, which allows people living with MS who wish to seek PONS treatment to conduct an online health evaluation with qualified medical providers, fulfill prescriptions, and arrange for PONS devices to be delivered directly to their doorstep. The first PONS devices were delivered in January, shortly after the site went live, and we've already seen strong adoption. Users appreciate the ability to shorten and streamline the process and achieve quicker release. We continue to tweak the process and online experience for PONS therapy patients and believe this will be the predominant method for cash pay patients to access PONS therapy in the U.S. PONS devices must be used in conjunction with supervised therapeutic exercise programs, and quickly matching patients with trained physical therapists is an important part of the process. Since introducing an online training portal last year, we've been able to train physical therapists at a quicker pace which means patients no longer need to wait months for a trained therapist to be available. Educating the broader community about the benefits of PONS therapy is another key part of reaching as many patients as possible. Last month at the American Academy of Neurology annual meeting in Boston, we exhibited PONS for the first time since its commercial launch. Because of the broader set of indications across North America, we were able to present new real-world efficacy and safety evidence regarding the effects of PONS therapy with stroke, MS, and mild to moderate TBI, traumatic brain injury, for patients. For instance, data from Canada shows that at the end of a 14-week PONS therapy treatment period, approximately 70% of stroke patients had a statistically significant improvement in their gait. And among them, 28% were no longer at risk of falling, a result of particular significance since routine rehabilitation physical therapy only provides a meaningful shift in the risk of falling in the 1 to 3% of stroke patients. Furthermore, 74% of individuals with traumatic brain injury experience significant improvement in their balance. PONS is authorized in the US for MS and has a breakthrough designation for stroke. But this evidence really sheds light on the ability of PONS therapy to mitigate the impact various life-altering neurological conditions can have on gait and balance. This is especially significant since according to the CDC, $50 billion is spent each year on medical costs related to non-fatal falls, and one out of five falls causes a serious injury. With that, I'll now turn to our Canadian activities. PONS has been commercially available since 2019 for MS and TBI and was recently authorized for stroke. an estimated 878,000 Canadians are currently living with stroke, with more than 89,000 new strokes occurring each year, and gait impairment is a major source of post-stroke disability. Not only was this a huge win for Canadians suffering balance and gait impairment due to stroke, but as I mentioned a moment ago, the broader set of authorizations highlights the therapeutic potential of POND, The real-world data we've gathered makes it increasingly evident that PONS therapy can provide significant and clinically meaningful improvement in balance and or gait regardless of the underlying medical conditions. In March, we extended our partnership with Health Tech Connect, a leading health technology company specializing in neurotechnology innovations. Our new agreement grants HTC the exclusive right to purchase, market, sell, and distribute ponds throughout the metropolitan Vancouver area, subject to certain minimums. HTC has been an important partner for Helios, and we're excited to deepen our presence in Vancouver through HTC's network of leading-edge neurorehabilitation clinics. With this partnership in place, And the multiple indications of the Canadian market could be as large as the U.S. market in the near term. Now, let me turn the call over to Jeff to discuss our first quarter financial results in detail.