Q2 2023 NeuroMetrix Inc Earnings Call
Participants
Shai N. Gozani; Founder, Chairman, CEO, President & Secretary; NeuroMetrix, Inc.
Thomas T. Higgins; Senior VP, CFO & Treasurer; NeuroMetrix, Inc.
Jarrod M. Cohen; MD; JM Cohen & Company
William Church
Presentation
Operator
Good morning, and welcome to the NeuroMetrix Second Quarter 2023 Business and Financial Highlights update. My name is Mikee, and I will be your moderator on the call.
On this call, the company may make statements which are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are predictive in nature that depend upon or refer to future events or conditions are forward-looking statements. Any forward-looking statements reflect current views of NeuroMetrix about future results of operations and other forward-looking information. You should not rely on forward-looking statements because actual results may differ materially as a result of a number of important factors, including those set forth in the earnings release issued earlier today.
Please refer to the risks and uncertainties, including the factors described under the heading Risk Factors in the company's periodic filings with the SEC available on the company's Investor Relations website at neurometrix.com and on the SEC's website at sec.gov. NeuroMetrix does not intend and undertakes no duty to update the information disclosed on this conference call.
I'd now like to introduce NeuroMetrix Senior Vice President and Chief Financial Officer, Mr. Thomas Higgins.
Thomas T. Higgins
Thank you, Mikee, and welcome to all of you who are joining Dr. Shai Gozani and myself for today's Q2 2023 update.
By way of background, we are a commercial-stage medical device company addressing unmet needs in chronic pain and in diabetes. Our products are (inaudible) invasive. They have no direct competition and offer a worldwide opportunity. Our business is based on a razor/razor blade model, with aftermarket revenue as the primary financial objective.
Our principal technologies are Quell, a wearable neuromodulation platform that has transitioned from over-the-counter to prescription, and DPNCheck, a legacy screening technology for peripheral neuropathy, particularly diabetes-related neuropathy. We maintain a strong balance sheet with about $19.6 million in liquid assets. Those are cash and securities. Our capital structure is simple and debt-free. There are approximately 8.6 million common shares outstanding.
Today, we reported Q2 revenue of $1.7 million compared with $2.1 million in Q2 of last year. The reduction in revenue reflects uncertainty in the Medicare Advantage market among health care insurers and providers caused by recent CMS changes in patient risk assessment rules. Our DPNCheck business, which sells into that market, experienced a net 16% drop from Q2 of last year. However, within that drop, there was a 30% gain in sales for China and Japan year-on-year. Other factors affecting the Q2 reduction in revenue were the Quell transition to a prescription indication wherein growing fibromyalgia sales partially offset the drop in over-the-counter and also the natural erosion of our legacy ADVANCE electrode sales, where we continue to support our existing users but do not promote the product and manage it for its cash flow benefits.
Aftermarket sales across all products constituted 75% of revenue in the second quarter. Our gross profit was $1.1 million compared with $1.5 million in Q2 last year, and the drop in gross profit links directly to the lower revenues. Importantly, our gross margin rate of 68% was consistent with Q2 of 2022.
Operating expenses totaled $2.7 million, virtually unchanged from the prior year quarter. A small increase in OpEx of $80,000 or about 3% reflected increased personnel costs, offset by reduced spending on professional services. Our net loss was $1.5 million in the quarter or $0.19 a share versus $1.2 million or $0.17 per share in Q2 of 2022. Operating cash usage in the quarter was approximately $1.5 million. Our $19.6 million in liquid resources are projected to be adequate to support the next phase of our Quell and DPNCheck growth initiatives.
And now for Dr. Gozani's comments.
Shai N. Gozani
Thank you, Tom. Our growth strategy is primarily built on 3 core efforts. The first is to establish and grow the core fibromyalgia indication in the U.S. market. The second is to advance the Quell neurotherapeutics program, which may lead to additional indications and an expanded addressable market. And the third is organic growth in the DPNCheck Medicare Advantage business. And I'll now comment on each of these activities.
First, with respect to our Quell Fibromyalgia business. Quell is our wearable neuromodulation platform. It is based on our proprietary adaptive transcutaneous electrical nerve stimulation technology and is the only daily, multi-hour wearable treatment for chronic pain syndromes. It is FDA-cleared for relief of lower extremity chronic pain and, last year, received FDA De Novo authorization as the first and only neuromodulation device indicated to help reduce the symptoms of fibromyalgia. This latter indication (inaudible). At this time, our commercialization efforts are exclusively focused on fibromyalgia indication. Fibromyalgia is a complex chronic pain syndrome that affects up to 15 million people in the U.S. The only FDA-approved drugs are pregabalin, duloxetine and milnacipran, which can have substantial side effects. There is a critical unmet need for additional safe treatments.
The second quarter of this year was the second quarter of the commercial launch of Quell Fibromyalgia and followed a small amount of activity in December. This initial phase is strategic and intended to optimize the effectiveness of our prescription processing solution to refine the clinical and marketing messaging and to collect key performance indicators. Our commercial team has consisted of a single dedicated headcount, which is our national director of sales. We have partnered with a national online pharmacy to fulfill both the initial prescriptions and refills. And at this time, Quell Fibromyalgia is only available on a cash-pay basis.
There were 123 unique prescribers during the second quarter compared to 92 in the first quarter. Most of it -- our most common prescribers are rheumatologists, pain medicine specialists and neurologists. The cumulative number of Quell Fibromyalgia prescriptions that have been written increased to 490 in the second quarter from 234 in Q1, with approximately 60% of RIN prescriptions being filled by patients. The cumulative number of month-refills increased to 348 in the second quarter from 141 in the first quarter.
As recently announced, we have expanded our sales force to drive further adoption. This stage of the commercialization process will focus on the Texas, California and Florida markets and that we expect to decide on our next expansion in the first half of next year.
The second element of our growth strategy is to develop the Quell neurotherapeutics pipeline beyond the initial fibromyalgia indication. The program that is the furthest along is the treatment of chronic chemotherapy-induced peripheral neuropathy, or CIPN, which affects as many as 30% of the approximately 1 million people in the U.S. who receive chemotherapy every year. It is a chronic and debilitating side effect of cancer treatment, and there are no FDA-approved treatments for CIPN.
Quell received FDA breakthrough designation for treating moderate to severe CIPN in January of 2022, based on a pilot study conducted at the University of Rochester. NIH-funded multicenter, double-blinded sham-controlled trial completed enrollment in the third quarter of last year, and we have now had an opportunity to review the results and have determined that they support a FDA 510(k) filing for a Quell CIPN indication, which we expect to make in the fourth quarter of this year. Depending on the FDA review time line and ultimate clearance decision, we believe that we should be in a position to initiate commercialization in the second half of next year.
Moving to DPNCheck. DPNCheck is our rapid point-of-care test for peripheral neuropathy, such as diabetic peripheral neuropathy, or DPN, which is the most common long-term complication of diabetes. DPNCheck is the only point-of-care peripheral neuropathy test based on gold standard nerve conduction study technology. Our DPNCheck business is comprised primarily of B2B sales into the U.S. Medicare Advantage market and international sales to China and Japan through distribution partners. About 80% of our DPNCheck revenues come from domestic sales.
This business has been growing for the past several years. However, in the past 6 months, substantial uncertainty was injected into the Medicare Advantage sector due to policy changes announced by the Centers for Medicare and Medicaid Services. We believe this uncertainty and other related factors led to our largest Medicare Advantage customer and several smaller customers suspending their medical screening programs, which included DPNCheck among other tests. At this time, we do not know if this is a temporary or permanent decision.
These Medicare Advantage changes are putting material downward pressure on DPNCheck revenues, although it's too early to determine the magnitude and direction of the impact. However, we expect that the DPNCheck business line will continue to generate positive cash flow by virtue of its attractive operating margins. We also believe there is a potential for resumed growth once we get through this period of uncertainty.
And that represents our prepared comments, and we'd be happy to take questions at this point.
Question and Answer Session
Operator
(Operator Instructions) Your first question comes from the line of William Church from TGRA Capital Management.
William Church
I was reading a study, University of Oxford Press December 2022, talking about -- title was using artificial intelligence to improve pain assessment and pain management. And they mentioned some of the numbers you do in terms of Americans experiencing pain. They concluded though collective studies mentioned have demonstrated that AI has advanced understanding in multiple areas of clinical care, but none has fully discussed the application of AI-based intervention and their assessment. .
That was a statement or a question because I'm thinking about pain, electric signals through the body's neural network, and Quell's device alleviate those. And it just seems that with the history you have and are gathering, you're really at the front line in terms of trying to find a less, noninvasive solution. I don't know if that's AI or non-AI, but it just seems to me like the data that you have and all the FDA -- or the clinical trials put your company in a pretty favorable position. So as I said, I don't know if it's a statement or a question, but that's all.
Shai N. Gozani
Thank you, Bill. I mean -- so AI, we view as a tool to leverage the data sets that we're collecting by virtue of having our device on so many patients. So we have very rich data sets. We have used basic AI techniques, machine learning in the past and continue to utilize that tool to improve the performance of our devices as well as the delivery of our solution to patients. So I think it's a good statement, and I think it sort of more -- it reflects the fact that I think that is a powerful utility that I think all medical device companies should be looking at, and we are among those.
William Church
Okay. Congratulations on the rollout of the product, and it looks exciting.
Operator
Your next question is from the line of Jarrod Cohen from JM Cohen & Company.
Jarrod M. Cohen
Just broad-based question because now I've seen a lot of -- just on television and just on the Internet, a lot of other pain management devices, a lot of quirky ones, advertised now on TV, some lower, some higher than what Quell used to be advertised online for over-the-counter, I'm saying. And I just wanted to see if you've seen those because that was obviously the problem you got, I think, feedback there. It was always overpriced -- over -- the price point was over too much, which I never thought. This is when it was priced at $250, and the electrodes were $30 each, whatever, depending on how much you use them per month or less. And I just wanted to get your feedback because I always thought it's a great device and [directly] -- either work for the person or not. Directly , there are no side effects.
Shai N. Gozani
Yes. Thank you, Jarrod. So our -- there is a lot of noise in the pain and management pain relief space. I think what you're seeing on TV and other, say, digital media, it reflects that. And I think that largely speaks to why we've taken this over the -- we've transitioned over the last several years from an over-the-counter focus to -- or what we would call our prescription neurotherapeutics effort where we are focusing on specific disease states where we have compelling clinical trial data, such as fibromyalgia, such as that's emerging for CIPN, where we can work with and, generally, I would say, convince physicians that this is a useful tool for them in their patients with those specific conditions.
So really kind of reflecting your comment is sort of that's the reason we've gone away from that generalized pain management space to focusing on specific disease indications and also why we're going through physicians as opposed to trying to compete in the broad -- kind of broad ether of over-the-counter pain relief, which I think is just very noisy and very difficult to rise above that -- above that noise. So we -- and we feel, based on our initial traction that we've experienced, that this is going to be a positive strategy to get Quell into the hands of patients.
Jarrod M. Cohen
Okay. It leads me to my next question. Because going through physicians -- frankly, who treats fibromyalgia? Is it that neuro -- neurologist or -- I have never been sure. Or is it just a -- who -- which type of doctor treats fibromyalgia?
Shai N. Gozani
Yes. So historically, fibromyalgia has been within rheumatology, although it's now understood to be a neurological condition. So you find -- I would say, the top 3 are rheumatologists, pain physicians for the obvious reasons, there's just a lot of pain associated with it, and neurologists.
Jarrod M. Cohen
Okay. Okay. And then, say, they go to -- and it's a prescription type. Where does the prescription come -- for the Quell come from? Does it come from a pharmacy? Or does the doctor give it to the patients themselves?
Shai N. Gozani
The prescription is sent to our pharmacy partner directly from the physician, either electronically or via fax, and then the pharmacy contacts the patient and completes the prescription and fulfills it, and then they ship the product to the patients.
Jarrod M. Cohen
And is it -- and then it's billed through the patient's insurance company.
Shai N. Gozani
At this point, we're not working through insurance. That -- maybe something we do in the future right now, but like any -- most online pharmacies, it's cash pay.
Jarrod M. Cohen
Okay. So it's still a cash pay, but FSA-reimbursable, I assume.
Shai N. Gozani
FSA- and HSA-reimbursable, it is.
Jarrod M. Cohen
Okay. All right. Then I won't to ask. All right. I guess the last -- did you -- I've always forgotten what's the broad market for fibromyalgia in terms of -- is it, what, $5 billion or $6 billion or more than that? Just out of curiosity. I know it's a lot. It's a broad question because I know, on an annual basis, what people charge for drugs in fibromyalgia, and an annual basis is probably, what, $10,000 or $12,000.
Shai N. Gozani
It was until those drugs became generic. So most of the widely prescribed fibromyalgia drugs, which are -- which were branded Lyrica and Cymbalta are now generic. So the market from that perspective has come down. There are probably as many as 15 million patients, at least probably 3 million to 5 million that are diagnosed and another 10 million that half (inaudible) are probably -- don't have a proper diagnosis. So it's a large market. I don't think there's an easy number to put on it, but it's a very prevalent condition and represents -- is really one of the more common forms of chronic pain. So large market but don't have a good dollar number to give you at this point because of the change in the market related to the fact that the drug has become generic.
Operator
(Operator Instructions) There are no further questions at this time. I would now like to turn the conference back to Dr. Gozani for closing remarks.
Shai N. Gozani
Thank you for joining us today on the conference call, and we look forward to keeping you updated over the balance of the year.
Operator
This concludes today's conference call. Thank you for participating. You may all disconnect. Have a great day.
