Solana Co Q2 FY2021 Earnings Call

Please standby. Good evening, ladies and gentlemen and welcome to the Second Quarter of Fiscal Year 2021 Earnings Conference Call for Helius Medical Technologies. At this time, all participants have been placed in a listen-only mode. Please note that this conference call is being recorded and that the recording will be available on the company’s website for replay shortly. Before we begin, I would like to remind everyone that our remarks and responses to your questions 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 Factors section of our most recent annual report on Form 10-K and quarterly report 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 August 12, 2021. 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 conference over to Mr. Dane Andreeff, Helius Medical’s President and Chief Executive Officer. Please go ahead, sir.

Great. Thank you, operator, and my apologies for the technical difficulties, but welcome everyone to Helius Medical's second quarter 2021 earnings conference call. I’m joined on the call this evening by Jeff Mathiesen, our Chief Financial Officer. Let me provide you with a quick agenda of what we are going to focus on today as part of our continued strategy to reposition Helius to create shareholder value. I’ll begin my remarks with a brief discussion on our progress in the United States and the initiatives we are focused on as we prepare for commercialization. I’ll then share a brief update on our commercial activities in Canada. Jeff will then provide you with a review of our second quarter financial results. And finally, following Jeff's remarks, I will share some closing thoughts before we open the call for questions. Before I continue, I believe it is important to stress that our commercial activities in Canada continue to provide the company with invaluable information and data about our PoNS device and treatment. We have been able to utilize this data to secure our first regulatory clearance in the U.S. and to inform our planning process for U.S. commercialization. We continue to expand our commercial activities and grow our business in Canada, and we consider this to be a very important market for PoNS. With that said, our belief is that the real value potential for Helius over the next few years is tied to the successful commercialization of PoNS in the U.S. for the treatment of gait deficits in MS patients, followed by the potential approval of the PoNS device for other indications in the U.S. With that as a backdrop, we are excited to share our recent progress with you. After obtaining the first U.S. regulatory clearance for our PoNS device in late March, our team has concentrated on preparing for U.S. commercialization as quickly and efficiently as possible with the aim of bringing our technology to the approximately 1 million U.S. patients suffering from MS, a significant unmet medical need. Our recent research, based upon our analysis of DRG code data, has allowed us to determine that our initial efforts will focus on a subset of approximately 130,000 MS patients with gait deficits who may require physical therapy. With this goal in mind, we’ve been focused on the following four initiatives as part of our pre-commercial activities in 2021. First, secure licensing and accreditation required to distribute our PoNS device across the U.S. Second, establish a dedicated team to lead our initial U.S. commercialization efforts. Third, refine our strategy to target, engage, and educate potential early adopters of our technology. And fourth, pursue reimbursement coverage for our PoNS treatment from Medicare and commercial payers. Let me take a minute to discuss each of these four initiatives in more detail and provide you with an update on our recent progress. Beginning with our efforts to secure licensing and accreditation in the United States, our team has been hard at work obtaining the licenses required to distribute our PoNS device in key states across the country. As of today, we are pleased to have secured the requisite licenses enabling Helius to distribute our PoNS device in 43 states. We expect to expand this coverage to nearly all the states by the end of this year in order to facilitate our initial commercialization effort in the first quarter of 2022. Turning to our second initiative. We made exceptional progress during the quarter in establishing and strengthening our leadership team to guide our strategy and support our operations in the U.S. Most notably, on June 1, we added key personnel to lead our sales and marketing strategy with the appointment of Fred Fantazzia as our Vice President of Sales and Marketing for North America. Fred joins our team with 16 years of sales and marketing experience in the field of neuromodulation, having worked in a variety of senior leadership roles. During his time, he led the company’s commercialization of neuromodulation technology for the treatment of drug-resistant epilepsy as VP of North American Sales and Marketing. He is an expert in developing the market for new neuromodulation technologies, and we are excited to have him managing our U.S. commercial effort. After a significant evaluation and deliberation, our Board of Directors made two important appointments to our executive leadership team on June 14. I was appointed President and Chief Executive Officer, and Jeff Mathiesen was appointed Chief Financial Officer. I remain a strong believer in Helius and its mission, and I’m convinced that our PoNS technology has the potential to revolutionize the treatment of many neurological conditions caused by disease and trauma. I appreciate the Board’s confidence in my capabilities, and as an executive and fellow shareholder of Helius, I remain committed to pursuing the successful U.S. commercialization of our PoNS treatment with an eye on creating shareholder value. My colleague, Jeff Mathiesen, previously served as Chair of the Company’s Audit Committee and has nearly 30 years of experience as Chief Financial Officer of growth-oriented technology-based companies, including publicly traded healthcare companies. I’m pleased to welcome him to the executive team and look forward to working closely together in the years to come. Lastly, I’m excited to report that in July we made another important addition to our team with the appointment of Dr. Antonella Favit-Van Pelt as our new Chief Medical Officer. Antonella is a board-certified neurologist with 20 years of experience advising and leading medical programs for healthcare companies. I believe she is the ideal candidate to lead our Medical Strategy as we raise awareness of PoNS treatment. With respect to our third initiative, our commercial effort will focus on facilitating demand by engaging three primary audiences: neurologists and other key physicians, personnel at key neuro rehab centers, and MS patients through information campaigns. Under the direction of Fred and Antonella, we are developing our strategy and processes to raise awareness of PoNS treatment among those key constituents. Importantly, we have mapped the key centers of excellence for both neurologists and neuro rehab centers that have the greatest potential to be early adopters of our technology. Our initial efforts will focus on 10 states that comprise more than 50% of the 130,000 targeted MS patients. As part of our efforts to raise awareness, we are pleased to announce the launch of our U.S. PoNS treatment website, www.ponstreatment.com, which expands our online resources for U.S. based clinicians and patients. Turning to our fourth and final initiative, while the majority of our initial U.S. customers are expected to be cash pay pending the receipt of widespread reimbursement coverage, we are actively pursuing coverage under commercial and government reimbursement programs. We are engaging with CMS to clarify and navigate the process of securing coverage, which will be an important component of our process. Overall, we are pleased with the progress we are making on our four initiatives, which represent our primary areas of focus as we prepare for commercialization. Importantly, our team has worked together to formulate a comprehensive U.S. commercialization plan for PoNS. Turning to a brief update on our commercial activities in Canada, as we discussed on our earnings call in May, the environment in Canada has been especially challenging during 2021 due to increased restrictions implemented to protect patient health and safety in response to COVID-19. Our team has continued to work resourcefully, interacting with our existing and potential clinics to position Helius for long-term success. Looking ahead, we are pleased to see Canada progressing through initial stages of recovery and, given those positive developments, we remain cautiously optimistic that recovery will continue to demonstrate traction as we move through the second half of 2021. With that, let me turn it over to Jeff to discuss our second quarter financial results.

Thanks, Dane. Good evening, everyone. It is a pleasure to be with you tonight on the first of what I hope to be many quarterly update calls. We reported revenue of $71,000 for the second quarter of 2021 compared to $133,000 in the second quarter of last year. Our revenue in both periods was driven by sales to neurotherapy clinics in Canada that are authorized to provide PoNS treatment, but have been significantly impacted by business disruption related to the COVID-19 pandemic. For the second quarter of 2021, our gross profit decreased to $4,000 versus $69,000 in the prior year. Operating expenses for the second quarter of 2021 increased by $2.4 million or 63% year-over-year to $6.2 million. These expenses included a non-cash $1.9 million increase in stock-based compensation expense, comprised of a one-time fully diluted stock option grant and stock options granted with the addition of management and sales executives. Operating loss for the second quarter of 2021 was $6.2 million compared to $3.7 million for the prior year period. We reported a net loss of $6 million or $2.58 per basic and diluted common share compared to a net loss of $3.4 million or $2.90 per basic and diluted common share for the same period last year. Turning to our balance sheet condition, our cash burn from operations for the first six months of 2021 was $6.7 million compared to $7 million during the first six months of 2020. As of June 30, 2021, we had $7.4 million in cash compared to $3.3 million as of December 31, 2020. We had no outstanding debt obligations in either period. Looking ahead, we expect our expenses in 2021 to increase in connection with our pre-commercialization activities. We will continue to maintain a disciplined approach to spending while evaluating options to strengthen our balance sheet and support our operations, including U.S. commercialization efforts. As for our expectations for third quarter sales performance, given the COVID-related headwinds and slightly relaxed restrictions in Canada, we currently anticipate third quarter total revenue to increase approximately 10% on a quarter-over-quarter basis. During the second half of the year, we expect to begin our U.S. commercialization during the first quarter of 2022, and therefore do not anticipate any revenue from sales of our PoNS device in the U.S. during 2021. As a reminder, we expect the second half of 2021 to reflect incremental investments related to our pre-commercial activities. With that, I'll turn the call back to Dane.

Thank you, Jeff. In conclusion, we are pleased to report continued progress in preparing for U.S. commercialization, which we remain on track to begin during the first quarter of 2022. I believe the quality of our team is one of Helius's strongest attributes. With this in mind, I'm especially pleased with the level of talent that we continue to attract to lead our U.S. commercial efforts. As we enter the second half of 2021, we will continue to execute on our strategic pre-commercial activities to position Helius to bring our PoNS technology to the large underserved population of U.S. MS patients as quickly as possible. We are excited by the potential of the U.S. market for MS, and we believe we may have the opportunity to become the standard of care for gait deficits in MS patients. We will continue to develop and capitalize on the long-term potential of our PoNS device as a platform technology by pursuing new indications for use and expanding its applications to treat multiple disease states. I would like to thank our teams in both the U.S. and Canada for their dedication and commitment to advancing our mission. A special thanks to our new and existing shareholders for their interest in Helius Medical Technologies. With that, Operator, let's now open the call for questions.

Thank you. Our question comes from the line of Jeffrey Cohen with Ladenburg Thalmann. Please proceed.

Dan and Jeff, how are you? Just so I have three, I'm going to start with Jeff actually. So the $4.744 million SG&A $1.9 million was non-cash, correct? Was there more than those non-cash or just the $1.9 million?

No, there's more of it. So the $1.9 million was actually the increased amount. And so if you look at the quarter, the total SG&A that was non-cash was just under $2.5 million and then R&D had another $162,000 of non-cash. So total non-cash expenses, operating expenses for the quarter were $2.6 million. So if you back that out, our cash operating expenses were about $3.6 million.

Yes, from the $6.170 million. That's great. Okay. That's helpful. Yes. Okay, got it. And Dan, could you talk a little more about the payers out there? And what are they looking for? What do they want on the evidence and data side, in addition to what you've done so far?

So with the new team involved, we're still focused on the MCIT rule and what that could bring us, so starting in the middle of December, we'll be waiting patiently for that decision. But we're also going to be advocating for the MCIT rule to be passed, partnering with potential MS organizations to help us through this critical pathway to have MCIT pass. On the commercial side, we're putting together our package of the dossier and health economics studies to help us through that process. We know that process can take some time. So we are forecasting on day one to be a cash pay market. So that's where we are today.

Okay, got it. And along those fronts, could you talk to us a little bit about the commercial facing folks out there, as far as what's there now up in Canada and in any that may be in the U.S., and then talk us through what that might look like, let's say by the balance of 2022?

Yes. I think that's a question for Jeff. So Jeff, can you?

Yes, I think as far as bringing on a sales force, we're really focused on 10 states but they're spread around the country. So there's really four key areas within that we're targeting for that. We’ll start by putting a sales leader in each one of those territories and then fill in below that person as we develop those out.

Okay. That’s it for me, thanks for taking my questions.

Our next question comes from Joe Gomes with Noble Capital Markets. Please proceed.

Hello. This is Gregory Aurand in for Joe. And I just have a couple of questions. Thanks for taking the questions. In terms of the number of clinics added in Canada, where are there additional ones in this quarter compared to the first quarter?

Okay. Jeff, I'm sorry. Yes, that’s the question…

Yes. So again, with the activity being kind of shut down, which has really clamped down during the quarter, we didn’t really have any additional clinic activity during the quarter, but as things are starting to open up, we’ll look to continue to add clinics.

Thank you. In terms of this new website, what kind of traction have you received so far and what kind of traction do you expect to get out of it?

So I'll answer that. It's a brand new website. It’s a landing page for clinicians and patients to be educated on our PoNS device and therapy. Right now we’re seeing some really good uptake in the MS community.

If you don’t mind one more follow-up in terms of any new applications in Australia, are there any movements there in terms of Australia?

Yes, we’re still pending with the TGA. It’s been quite a while, but we’re waiting for their decision on our application.

Great. Thank you so much.

Thank you, Greg.

Our next question comes again from the line of Jeffrey Cohen with Ladenburg Thalmann. Please proceed.

I wanted to jump back in with one more, if I may. I think for Dane, could you talk about in the U.S. how this may look from the commercial payer point of view? Would this be an upfront payment followed by scripts for a particular amount of energy per therapy?

Jeff, we’re looking at a prescription by the neurologist, so it would be an upfront prescription.

Okay. And it would need to be refilled periodically every quarter, every month?

That will be up to the prescribing neurologist.

Yes. Actually, I think – this is Jeff. I think if you’re asking, so the initial prescription is a 14-week therapy, which is the PoNS system. So the patient in the U.S. would then be the owner of the controller if there’s additional treatment prescribed it would be for additional mouthpieces. But the controller would be with the patients. So any additional beyond the first treatment would be a mouthpiece component and not the full system.

Does that answer your question?

I think so, should there be two different prescriptions? It would be an initiation of therapy and a follow-on of therapy in the case of patients.

As far as the way it’s prescribed, I’m not sure if the prescription would look different. But after the initial prescription, if the patient needs another 14 weeks, it would be the mouthpiece that they will need to complete that second round of therapy.

Yes. Okay. Got it. Thanks for taking my questions.

Thank you. We are currently showing no additional participants in the queue. That does conclude our conference call for today. Thank you for your participation.

Thank you, everyone.