Solana Company

Good day, everyone. My name is Chelsea, and I will be your conference operator. At this time, I'd like to welcome everyone to the Helios Medical Technologies third quarter 2023 financial results. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer period. At that time, if you have a question, please press star 1 on your telephone keypad. As a reminder, this conference call is being recorded today, November 9, 2023. It is now my pleasure to turn the floor over to Michelle Bilski, Investor Relations for Helios Medical Technologies.

Please go ahead. Thank you, Chelsea. Welcome to the third 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 Andreece, Helios Medical's President and Chief Executive Officer, and Jeff Mathieson, Chief Financial Officer. At this time, all purchase events 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 Helios website at www.heliosmedical.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 could 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 with the SEC, which are available on our website. All statements made during this call are as of November 9th, 2023. We undertake a 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 turn the call over to Dane Andrees, President and Chief Executive Officer of Helios.

Thanks, Michelle. Welcome, everyone, to Helios Medical's third quarter 2023 earnings conference call. We began the quarter with the conclusion of our very successful patient therapy access program, which we launched in June 2022 to give qualified Americans suffering from balancing gait impairment due to MS the ability to purchase ponds at a significantly reduced price. The implementation of PTAP enabled us to accomplish two key objectives. By subsidizing the cost of ponds, we meaningfully reduced a major barrier to use while also adding to our MS patient registry. Through the registry, we can collect important health economic information to establish the value of ponds on key clinical and therapeutic outcomes, which is critical as we pursue reimbursement. As expected, quarterly sales of PON systems in the U.S. decreased following the expiration of the PTAP program on June 30th, as sales of PON systems reverted to the cash pay price. We continue to believe that broad third-party payer reimbursement is needed to achieve our full revenue potential, and I'm pleased to report we're moving closer to that goal. In September, the PON system and mouthpiece were assigned UPC numbers, the equivalent of NDC numbers for pharmaceuticals, with the listed price of $25,700 and $7,900 respectively. The UPCs are now included in the Walters Kluwer Health's Pharmacy Database. to which 17 of the top 20 grossing PBMs are subscribed. Receiving the UPC numbers was a game changer for Helios because with the DME accreditation announced last quarter, PONS is now one of the few products with pharmacy and device codes, which means two paths towards reimbursement. We are also steadily moving toward our goal of achieving U.S. authorization for stroke. We recently established relationships with two important Canadian healthcare providers, having received an order for 10 PON systems from the School of Rehabilitation at the University of Montreal, as well as a letter of intent from the Quebec Ministry of Health and Social Services to purchase 30 pond systems to treat gait imbalance in stroke patients. These are exciting opportunities and both come about due to the body of clinical evidence demonstrating the effectiveness of using PONS to treat stroke. Among other outcomes, PONS therapy has been shown to reduce the risk of fall in 28% of stroke patients as opposed to a reduction of just 1% to 3% with physical therapy alone, which is the current standard of care. Stroke patients experience a significant increase Improvement in gait, averaging a 6.74-point improvement in the functional gait assessment score over the 14-week treatment period. Overall, 69% of the patients experienced at least a 5-point FGA improvement, which is larger than the 4.2 minimal detectable change usually seen in stroke patients. The fact that these two institutions committed to purchase PONS reflects the medical community's strong desire to improve treatment for this patient population, and we believe that evidence from the treatment outcome will support health economic benefit and cost effectiveness of incorporating PONS therapy as a first-line treatment for stroke patients. Furthermore, this evidence should provide valuable benchmark for other Canadian health care providers and private payers as they evaluate reimbursement upon therapy. The data from these clinical application trials will also provide supporting evidence upon therapeutic benefit that can strengthen the registrational program for stroke currently ongoing in the U.S., where there are more than 5.5 million people experiencing impaired walking due to stroke. If and when PONS is approved to treat stroke in the U.S., it will be eligible for coverage under the proposed transitional coverage of emerging technologies or T-SET pathway, which would expedite Medicare coverage of certain breakthrough devices by allowing manufacturers the opportunity for increased pre-market engagement with CMS. Helios has two breakthrough designations granted by the FDA, putting us among the less than 1% of medical device companies that have a breakthrough designation, with our second one in balance and gait deficit due to stroke. While we don't know the outcome of this bipartisan piece of legislation, we are optimistic about its potential and the fact it provides another pathway toward reimbursement and greater access for patients. We are always looking for ways to help reduce barriers to PONS use. Earlier this year, we launched our Upscript e-commerce telehealth platform to make it easier for people suffering from MS to access pond therapy and start treatment more quickly instead of having to wait up to three months to see their neurologist. The platform offers, among other services, online health evaluations with qualified medical providers, a fulfillment of prescriptions required for PONS therapy, and the shipping of PONS devices directly to the homes of eligible patients in the United States. As you can imagine, this is a great benefit to those who face mobility challenges. We are pleased to report that virtually all the prescriptions in the United States are now fulfilled through Upscript. We also continue to expand PondSTEP, our company-sponsored outcome research trial designed to evaluate the real-world impact of MS patients' adherence to Pond's therapy. We recently added Montefiore Medical Center in Nyack, New York, to the program, bringing the total number of PONSTEP centers of excellence to six. We have increased enrollment at each site with the goal of enrolling five to 15 patients per site. Enrollment in PONSTEP began during the fourth quarter of 2022 and will continue throughout March of 2024. Turning now to our Canadian activities, Revenues in Canada were $72,000 during the quarter, up 29% over the third quarter of last year. We are starting to see traction with the exclusive distribution agreement with HealthTech Connect for portions of Western Canada that we signed at the end of the first quarter and expect steady overall growth to continue. Earlier this week, we were proud to announce the results of a study performed by Pacific Blue Cross and Health Tech Connect with the ultimate goal of reducing long-term disability and improving the quality of life for individuals suffering from traumatic brain injury in Canada where PONS is authorized to treat TBI. The program participants were all at least two years post-injury and had not responded to standard rehabilitation treatments and not expected to return back to work. The results were truly remarkable. Eighty-nine percent of the patients suffering from long-term disability due to chronic TBI said that balancing gate issues were no longer a barrier to return to work. 56% of the participants actually returned to work. And remember, these patients were deemed unlikely to resume their jobs. 80% of those returned to their prior occupations full-time for at least six months. In addition to significant improvements in balance and gait, Patients reported improvement in headache severity as well as in cognitive and mental health symptoms. It was also found that PONS therapy reduced the financial burden to the insurance provided by at least $1.6 million for the five individuals who returned to work for nearly a 10x savings on cost. This was an important study given that 7 million people in North America suffer from chronic balance deficit and other disabilities related to TBI. Rehabilitation therapy is the current standard of care, but its return to work rate is very low, and a large percentage of patients end up on long-term disability, often permanently. We believe the findings from this collaboration may promote our efforts to gain reimbursement by Canadian insurance companies and healthcare providers, as well as demonstrating that PONS therapy's significant health economic benefit and cost effectiveness as we negotiate coverage with US payers. It was a busy quarter for us at Helios, and we're excited about what we accomplished and the road ahead. With our continued focus on cash management and a runway that will take us into the second quarter of 2024, we have both the drive and resources necessary to continue pushing forward and bringing our life-changing therapy to as many patients as possible. With that, let me turn the call over to Jeff to discuss our third quarter financial results in detail.