Solana Company - Q1 2024

Executive Summary

• Q1 2024 revenue was $0.135M (+21.6% YoY), with net loss of $2.516M and diluted EPS of $(3.08); operating loss improved vs Q1 2023 driven by lower SG&A and R&D.
• Reimbursement momentum: CMS assigned HCPCS codes (effective Apr 1) and issued preliminary Medicare payment determinations; management expects final rates effective Oct 1, 2024, positioning reimbursement as the key near-term catalyst.
• Strategic access: Partnership with Lovell Government Services to make PoNS available to VA/DoD; training and contracting expected to enable initial VA prescriptions beginning around early June following internal team training.
• Funding runway extended: Closed a $6.4M public offering (~$5.6M net), extending cash runway into 2025 and supporting the stroke registrational program targeting early 2025 FDA submission.
• Estimates context: S&P Global consensus for Q1 2024 EPS/revenue was unavailable; comparisons to Street estimates cannot be provided (limited micro-cap coverage likely) [GetEstimates unavailable].

What Went Well and What Went Wrong

What Went Well

• CMS progress: “We marched one step closer to an important milestone when CMS released its preliminary Medicare payment determinations... Once finalized, the payment rates are expected to be effective October 1” (CEO).
• Access channels: Partnered with Lovell Government Services to supply PoNS to VA/DoD; management highlighted training and rollout plans to begin processing prescriptions following internal training completion (corrected to early June).
• Stroke program advancement: Added six more sites in U.S./Canada and aligned with FDA to streamline registrational program; management remains on track for early 2025 FDA submission using breakthrough designation.

What Went Wrong

• Revenue base remains muted due to cash-pay economics; cost of revenue largely flat given fixed overhead, constraining gross profit to $12K in Q1.
• Continued net losses: Q1 net loss of $2.516M and operating loss of $3.416M; cash used in operations was $3.0M, reflecting early-stage commercialization ahead of reimbursement coverage.
• Lack of explicit financial guidance (revenue/margins) and no non-GAAP metrics to frame near-term profitability, limiting visibility until CMS final rates and broader third-party coverage arrive.

Transcript

Operator (participant)

Good day and thank you for standing by. Welcome to the Helius Medical Technologies Q1 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you'd depress star one one on your telephone. You'll then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michelle Bilski with In-Site Communications. Please go ahead.

Michelle Bilski (Head of Investor Relations)

Thank you, Kevin. Welcome to the Q1 2024 earnings conference call for Helius Medical Technologies. This is Michelle Bilski of In-Site Communications, Investor Relations for Helius. With me on today's call are Dane Andreeff, Helius Medical's President and Chief Executive Officer, and Jeff Mathiesen, 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 Helius website at www.heliusmedical.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, including statements regarding potential reimbursement pricing, 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. 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 May 13, 2024. 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 turn the call over to Dane Andreeff, President and Chief Executive Officer of Helius.

Dane Andreeff (President and CEO)

Great. Thanks, Michelle. Thank you to everyone joining us today on Helius Medical's Q1 2024 conference call. In 2024, our focus remains on two things: securing widespread reimbursement for PoNS and achieving FDA approval for stroke. We made progress on both fronts and are confident these milestones are just around the corner. The $6.4 million financing we just announced last week, which extends our cash runway into 2025, will help get us there. I'll start with our pursuit of widespread reimbursement for PoNS. We are pleased that CMS Medicare understood the benefits of this innovative treatment and established HCPCS codes for both the PoNS mouthpiece and controller, which went into effect on April 1st. This was a critical reimbursement and access milestone, and the unique HCPCS codes give us the ability to begin negotiating reimbursement with third-party payers.

As a reminder, the list price for the PoNS device in North America, where it's indicated, is $25,700, comprised of $17,800 for the controller and $7,900 for the mouthpiece. Earlier this month, we were pleased to learn that CMS had released its preliminary Medicare payment determinations for the PoNS controller and mouthpiece and placed Helius on the agenda for the public meeting with CMS on May 29th. As the preliminary payment determination is subject to change, we are looking forward to presenting arguments at the meeting on the 29th to support higher reimbursement rates. PoNS is different from any neuromuscular peripheral stimulation therapy, and so for the controller, we'll advocate using the gap-filling methodology based on our list price versus mapping it out to other not-comparable neuromuscular stimulation devices.

For the mouthpiece, we will argue that it is actually a supply that is applied to an individual's tongue, and therefore the lump sum payment structure is more appropriate than the cap rental structure set in the preliminary determination, and therefore the gap-filling should be done using the list price. We believe we are in a good position to secure higher rates than those established in the preliminary determination. Once finalized, the payment rates are expected to be effective October 1, 2024. We believe the final determination of these rates will make it easier to expand reimbursement across third-party payers, creating a pathway to positive cash flow as we continue working to secure FDA authorization under PoNS Breakthrough Designation for stroke. We look forward to keeping you updated on our evolving discussions with CMS.

Turning now toward our pursuit of stroke authorization in the United States, we made several important strides toward this objective during the quarter by adding six more sites to the stroke pathway in both the U.S. and Canada. Based on encouraging results from an earlier trial, as well as real-world evidence from Canada where PoNS is already authorized for treatment of stroke, the clinical program aims at establishing the effects of cranial nerve non-invasive neuromodulation using PoNS Therapy on gait and dynamic balance in chronic stroke survivors.

Since gait imbalance deficit is a medical condition that almost inevitably leads to falling and increases the healthcare cost burden for these patients, the stroke registrational program also aims at confirming our real-world evidence that PoNS Therapy significantly reduces the risk of falling in at least 28% of stroke patients with gait imbalance deficit as compared to the average 1%-3% from physical therapy alone. In January, we announced the addition of Brooks Rehabilitation Hospital to our stroke clinical program, and it is the first site to have started enrolling patients in the open-label study, which is an integral part of our stroke registrational program because it brings the PoNS clinical experience to additional sites in the United States. Last month, we announced the participation of Shepherd Center in our registrational program.

Recruitment for the single-arm study begins this month with a goal of enrolling 8-10 participants by the end of the year. Shepherd Center has already been a valuable partner for Helius as part of our PoNS Therapeutic Experience Program, which was designed to evaluate the impact of subjects' adherence to PoNS Therapy in people with multiple sclerosis, MS. In addition to adding more sites to our stroke pathway during the quarter, we aligned with the FDA on our development plan to significantly streamline the size, timeline, and the cost of the registrational program. We are targeting regulatory submission by early 2025 with the goal of receiving marketing authorization utilizing PoNS Breakthrough Designation in stroke later in the year.

Well over 5 million stroke survivors in the United States are affected by walking and balance disability, and we are excited for this groundbreaking treatment to reach those who need it. As we continue to pursue stroke approval, we remain committed to getting PoNS Therapy into the hands of more people suffering gait imbalance impairment due to MS. Those efforts include ongoing engagement with the physical therapist community, and we now have PoNS-trained therapists located nationwide. We attended recently the American Physical Therapy Association combined sections meeting where we had the opportunity to further highlight PoNS therapeutic benefits. PTs are critical to patient success with PoNS, and we're always eager to engage with this important group. Last quarter, I mentioned our efforts to target the Department of Veterans Affairs, which is the largest integrated healthcare system in the United States and sees more than 28,000 cases of MS annually.

I'm pleased to report that we're officially partnered with Lovell Government Services, an approved supplier to the VA and DoD, to make PoNS available to federal healthcare systems. We've seen firsthand how PoNS Therapy has improved the lives of veterans suffering from MS, and we're thrilled that more service members will have access to this treatment. Turning now to our Canadian activities. In Canada, where PoNS is already authorized for stroke, we are currently working to establish sites in five separate administration regions as parts of a government-funded initiative designed to further validate the effectiveness of PoNS Therapy when used by patients suffering the effects of stroke. We believe this initiative will not only accelerate adoption in Canada but also benefit our pursuit of market access and third-party coverage here in the United States.

Moving into the rest of 2024, achieving reimbursement and making progress on our stroke registrational program remain our top priorities, and both goals are in sight. We could achieve CMS reimbursement as early as October 1st, which would enable us to expand reimbursement across third-party payers, significantly boosting our revenues and giving us a pathway to positive cash flow as we pursue authorization for stroke. With that, let me turn the call over to Jeff to discuss our Q1 financial results in more detail.

Jeff Mathiesen (CFO)

Thanks, Dane. It is a pleasure to be with you today. Total revenue for the Q1 of 2024 was $135,000, an increase of $24,000 compared to $111,000 in the Q1 of 2023, reflecting increased product sales in both the U.S. and Canada. For the Q1 of 2024, cost of revenue was $123,000 compared to $122,000 for the prior year period, remaining relatively flat due to fixed overhead costs. Selling, general, and administrative expenses for the Q4 of 2024 decreased to $2.6 million compared to $2.9 million in the Q1 of 2023 due primarily to a decrease in professional fees and payroll-related expenses, partially offset by an increase in contract manufacturer expense associated with the transition to the new contract manufacturer during the current year period.

Research and development expense for the Q1 of 2024 decreased to $0.8 million compared to $0.9 million in the Q1 of 2023, driven primarily by a decrease in product development expenses and clinical trial activities as we transitioned our focus to U.S. commercialization activities. Operating loss for the Q1 of 2024 was $3.4 million compared to a loss of $3.8 million in the prior year period. We reported a net loss for the Q1 of 2024 of $2.5 million or a loss of $3.08 per basic and diluted common share. We also had a net loss of $2.5 million in the prior year period or a loss of $4.42 per basic and diluted common share. Our cash burn from operations for the Q1 of 2024 decreased to $3 million compared to $3.2 million in the Q1 of 2023.

As of March 30, 2024, we had $3.6 million in cash and no debt. Last Thursday, we closed on a $6.4 million public offering and received net proceeds of approximately $5.6 million, which will extend our cash runway into 2025. Importantly, this financing also includes one-year warrants for an additional $6.4 million of gross proceeds that are callable by the company within 30 days of announcing the final reimbursement determination for the PoNS controller and the mouthpiece by CMS if the stock price at that time is at or above $2.25 per share. We expect final determination to be announced in late summer to be effective October 1st of this year. If exercised, the additional proceeds from the exercise of these warrants will fund our operations well into the second half of next year and helps to take financing risk off the table. Turning now to our (inaudible).

While PoNS sales remain on a cash pay basis and at a price point that is not feasible for the vast majority of patients in our addressable markets, we will expect revenues will continue to be muted. However, as we have discussed, our recent access to the VA patients through Lovell Government Services and the expectation of CMS reimbursement by October 1st, which will facilitate our efforts to expand reimbursement across third-party payers, we believe will position us to significantly boost our revenues beginning later this year and provide us a pathway to positive cash flow. With that, Kevin, let's now turn the call over for questions.

Operator (participant)

Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star 11 again. We will pause for a moment while we compile our Q&A roster. Our first question comes from Nicholas Sherwood with Maxim Group. Your line is open.

Nicholas Sherwood (Equity Research Associate)

Hi. Congrats on the quarter. Can you just go into a little bit more on the timeline with the Lovell Government Services agreement that you signed? Kind of where are you at with that agreement, and do you have to build out a sales team with them or just kind of get some more color on it?

Dane Andreeff (President and CEO)

Yeah. Hey, Nic. Thanks for your question and your comment. So we're in the process right now of having our PoNS Therapy be on contract with the FSS and the GSA contracts, the General Services Administration. This should go public very soon in the next days, weeks. And then by January 1st, our team and their team will be all trained up internally, and we could start receiving prescriptions, invoices, and training VA rehab experts on PoNS Therapy so that they could start treating their patients.

Jeff Mathiesen (CFO)

Dane, and I think you misspoke. You said January 1st.

Dane Andreeff (President and CEO)

Oh, I'm sorry.

When they would be trained.

I mean, June 1st. June 1st.

Yes. Yes.

Sorry. Thank you. June 1st. Thanks, Kevin.

Nicholas Sherwood (Equity Research Associate)

Yep. Yep. Okay. So June 1st, you expect to start receiving prescriptions?

Dane Andreeff (President and CEO)

Sometime in, hopefully, early June. There's some training on both sides, but we do have a couple of the VAs looking at PoNS Therapy for their MS patients right now. So it's very exciting. They've already targeted at least we know one VA of 25% of their MS population at that VA.

Nicholas Sherwood (Equity Research Associate)

Understood. And then kind of switching to.

Dane Andreeff (President and CEO)

Just to clarify.

Nicholas Sherwood (Equity Research Associate)

I'm sorry.

Dane Andreeff (President and CEO)

I was just going to say, so there's a little bit of an order process. So as they are looking to write a prescription, we would need to make sure that they've got someone trained there before the order could get placed with us. So there's a little bit of an order process that plays out as we're developing these new relationships.

Yep. And Nic, if you remember, we.

Nicholas Sherwood (Equity Research Associate)

When you say physical therapy, do you mean a PT?

Dane Andreeff (President and CEO)

Correct. Yes. Physical Therapist, that would be the one to administer or help with the treatment.

Jeff Mathiesen (CFO)

Just to follow on that, yes. If you remember, we modularized our PT training. Once they receive access to the modularized software, they could do it within three hours or less.

Nicholas Sherwood (Equity Research Associate)

Okay. That kind of leads into my next question. What demand have you seen from new physical therapists taking the training program for the PoNS Therapy?

Dane Andreeff (President and CEO)

Yep. It's been steady and upwards, Nic, on both sides of the border. What we're seeing, let's start in Canada. We're seeing this because the commercial payers want to see more of the map filled in. So we've really pushed into British Columbia because of what we're doing there. If you remember the Pacific Blue Cross study in Back to Work for traumatic brain injury, we had a very successful study that was performed by Pacific Blue Cross. Eight out of the nine had no longer an issue with balance and gait in returning back to work. And of course, they closed out five of their long-term disability claims to save CAD 1.6 million. So that is really an exciting time for us. The payers do want to see us fill in the map with Registered PoNS Trainers in Canada.

And in the United States, we believe that will be part of the process as well. And remember, most patients don't want to be driving more than 30 minutes to and from their PT because the first two weeks PoNS is performed in clinic. So the closer we can get Registered PoNS Trainers to the patients, it makes it much easier for the patient to meet their PT.

Nicholas Sherwood (Equity Research Associate)

Are you.

Dane Andreeff (President and CEO)

It's a steady increase.

Nicholas Sherwood (Equity Research Associate)

Are you targeting specific physical therapists to make sure that you have that geographic coverage in the United States if and when the CMS codes and that reimbursement is approved?

Dane Andreeff (President and CEO)

So actually, what we're seeing, Nic, is we're seeing a lot of patients wanting to file claims that are coming from existing registered PoNS trainers, which is a good thing. And these are one-off claims for MS for their gait deficit. And we could be helpful there. We're excited to help them with the commercial payers and start their PoNS Therapy as soon as possible. But our goal with reimbursement is also be able to sit down with some of the regional, superregional physical therapy chains. And we'd like to partner with them to quickly fill in the map once reimbursement goes effective, hopefully, on October 1st of this year.

Nicholas Sherwood (Equity Research Associate)

Understood. Well, that takes care of all my questions. Thank you for providing all that detail. I'll hop back into the queue.

Dane Andreeff (President and CEO)

Great. Great. Thanks. Thanks, Nic.

Operator (participant)

Again, ladies.

Nicholas Sherwood (Equity Research Associate)

Thank you.

Operator (participant)

Again, ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. I'm not showing any further questions at this time. I'd like to turn the call back over to Dane for any closing remarks.

Dane Andreeff (President and CEO)

Great. Thanks, Kevin. And thank you, everyone, for following Helius Medical Technologies. Before we go, I just want to thank the team at Helius for their hard work and dedication to bringing PoNS Therapy to the millions who need it. We're right on the cusp. We're excited about our upcoming milestones and look forward to keeping you updated as we pursue coverage and reimbursement and authorization and stroke. Thank you again.

Operator (participant)

Well, ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.