NeuroMetrix Inc (NURO) 2012 Q2 法說會逐字稿

Good morning and welcome to the NeuroMetrix second-quarter 2012 conference call. My name is John and I will be your moderator on the call.

NeuroMetrix is a medical device company focused on diabetes and treatment of the neurological complications of diabetes. The Company currently markets products for the detection, diagnosis, and monitoring of diabetic neuropathies such as diabetic peripheral neuropathy and median neuropathy, carpal tunnel syndrome.

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 that include words such as believe, may, will, estimate, continue, anticipate, intend, expect, plan, or other similar expressions 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. The risk and uncertainties, including the factors described under the heading "Risk Factors" AND the Company's final prospectus under the heading "Risk Factors" filed with the SEC on February 8, 2012 in connection with the Company's public offering and available on the Company's Investor Relations website at www.NeuroMetrix.com and on the SEC's website at www.SEC.gov and any updates contained in the subsequent SEC filings. NeuroMetrix does not intend to and undertakes no duty to update the information disclosed on this conference call.

I'd now like to introduce the NeuroMetrix President and CEO, Dr. Shai Gozani. You may begin.

Thank you. I'm joined on our call today by Tom Higgins, our Chief Financial officer, and K. Balachandran, our Chief Operating Officer. We are here to review our financial results for the second quarter of 2012 and to provide an update on our diabetes business strategy. Following our prepared remarks, we will be pleased to respond to your questions.

We had an encouraging second quarter with only six months of commercial experience in the diabetes sector. Going into the second quarter, we had several notable achievements. These reflect an increasing recognition of the clinical benefits that our technology brings to people with diabetes and the clinicians that take care of them and also provides validation of our market plans.

Before getting into the details, let me remind you of our diabetes focus and products. We are narrowly focused on peripheral nerve disease, which is a leading complication of diabetes and is called diabetic peripheral neuropathy, or DPN. DPN causes sensory loss that can lead to foot ulcers and amputations. It is often associated with severe foot pain. DPN is estimated to affect over 50% of people with diabetes and has direct costs exceeding $14 billion in the United States alone.

There are no medical device companies exclusively focused on this sector. We believe that the DPN market opportunity, including both diagnostics and therapeutics, is at least $2 billion. Our goal is to build an attractive, profitable franchise addressing diabetic neuropathy.

Our first diabetes product, the NC-stat DPNCheck, which is a fast, accurate, quantitative, point-of-care test for peripheral neuropathy such as DPN. The device employs single-patient use disposable biosensors. We launched the product about nine months ago, in September of 2011. Our initial target market was endocrinology and podiatry in the United States. More recently, we have recognized that the market with the most significant near-term opportunity is Managed Care. We also believe that the US primary care market and international markets represent attractive longer-term opportunities.

Our second product is SENSUS, which is a pain management device designed to provide relief from chronic pain in the lower legs and feet. SENSUS is the next product in our development pipeline and is currently undergoing 510(k) review by the FDA. We plan to launch SENSUS in the fourth quarter of this year, subject to completing the FDA review process.

Now, with respect to our second-quarter achievements, first on the Managed Care market, we have targeted Managed Care as our largest near-term opportunity. It has the important characteristics of size, patient concentration, emphasis on preventative care to improve outcomes and lower costs and centralize decision-making.

Within Managed Care, capitated Medicare Advantage plans, often called Medicare HMOs, represent over 7 million covered lives and are particularly attractive. We achieved our first major success in Managed Care with the second-quarter adoption of the NC-stat DPNCheck technology by WellMed, which is a large, San Antonio-based provider with operations in Texas and Florida. WellMed delivers healthcare services to approximately 100,000 Medicare Advantage patients. It has incorporated peripheral neuropathy testing, mostly for DPN, into its patient assessment protocols and intends to regularly test its patients.

During the second quarter, we delivered over 100 devices and associated consumables to WellMed and worked with them to initiate their testing program. In addition, our Chief Medical Officer, Dr. Ken Snow, participated in WellMed Ground Rounds to provide further program support.

WellMed has enhanced our understanding of this sector and validated our market assessment. It also provided us with excellent training and integration of NC-stat DPNCheck into a large, multi-site operation. We now better understand the needs of this market sector and are improving our support capabilities. Our Managed Care pipeline is growing and we are optimistic about our prospects in this market.

In respect to Retail Health, in the first quarter, we reported a large order from Walmart Canada for approximately 100 NC-stat DPNCheck devices plus consumables. That order was shipped during the second quarter. We also trained Walmart certified diabetes educators who will be using the devices. In late June, Walmart Canada kicked off a new comprehensive neuropathy and foot examination service incorporating the NC-stat DPNCheck into all its pharmacies that have a diabetes focus. The program goals are to increase association of Walmart with diabetes products and services and to expand relationships with local physicians who provide healthcare to their diabetes community. The neuropathy and foot examination program is in its early stage and we should get some indications of its progress later this year. We believe that the retail healthcare market, which includes large chain drugstores such as Walmart, CVS, Walgreens, and others, represents an important opportunity to expand awareness of diabetes-related nerve disease as well as name recognition for NC-stat DPNCheck.

With respect to the endocrinology and podiatry market, this is something we approached our direct sales force of 10 sales representatives. This salesforce posted a steady performance in the second quarter with orders of 105 NC-stat DPNCheck devices, which is roughly in line with the 109 devices in the first quarter. During the quarter, we did increase the initial order size from 100 -- from 50 to 100 biosensors, which had a positive effect on margins without depressing demands.

In terms of our overall sales results, we reported revenue from diabetes products of $648,000 in the second quarter. This was a substantial increase from $137,000 in the first quarter and reflected the benefits of large sales to WellMed and Walmart Canada. Our primary goal in 2012 is to achieve an installed base of 1000 devices by the end of the year. In May, we reported our 500th placement. At quarter end, we had 572, well on our way to meeting our annual target.

Now, turning to product development, we continue to make development product on SENSUS, our pain management device which is a transcutaneous electrical nerve stimulator intended to be used in the symptomatic relief and management of chronic and trackable pain. Several evidence-based reviews including by the American Academy of Neurology have recommended that transcutaneous nerve stimulation should be considered in the treatment of painful diabetic neuropathy.

SENSUS employs the same sophisticated nerve stimulation technology as NC-stat DPNCheck and includes advanced features that we believe may address the technical and clinical limitations of existing neurostimulators. SENSUS also includes technology to maximize patient compliance, which is one of the fundamental challenges with pain therapy.

During the second quarter, we filed a 510(k) on the SENSUS device followed by a second 510(k) on the consumable electrode. The FDA review process is underway, and we have responded to questions from the Agency. We are working on our commercialization plans, including early discussions with potential DME distributors, and remain on track towards a fourth-quarter market launch.

SENSUS attracted considerable attention at the June American Diabetes Association meeting. Comments on the device included its ease-of-use, wearable design, and the ability to get on-demand analgesia.

Our market outlook for SENSUS is positive. The two leading therapies for painful diabetic neuropathy, Pfizer's LYRICA and Lilly's Cymbalta have annual revenues exceeding $1.5 billion. We estimate the accessible US market for SENSUS to be over $100 million, reflecting the 10% to 20% prevalence of painful diabetic neuropathy as well as fairly consistent reimbursement policies.

We are at the halfway point of the year. We have confidence in our business plan and are making good progress. The Managed Care opportunity is compelling and SENSUS is on track. And of course, we continue to carefully manage our financial resources.

I will now turn it over to Tom for a discussion of the financials.

Thanks, Shai.

Our financial highlights combine two operations. These are our emerging diabetes business, which made its first commercial shipments in the fourth quarter of last year, and our historical general purpose neurodiagnostics business. Diabetes is our sole business focus and we are investing in its growth through our sales and marketing efforts and our new product development programs. Conversely, we have tight containment of spending on neurodiagnostics. It is in decline and we manage it for cash flow. The neurodiagnostic business contributes the majority of our revenues.

In the financial results, our Q2 revenue was $2.2 million. Diabetes revenue from the NC-stat DPNCheck device and biosensor sales was $648,000. We shipped a total of 317 new device orders and a small number of biosensor reorders.

WellMed and Walmart Canada were the largest contributors to revenue and the units shipped. And in comparison, diabetes revenue in the first quarter of this year was $137,000, and we shipped 152 devices.

Our cumulative device shipments through June 30 totaled 572, putting us on track with our 2012 goal of 1000. We highlight this metric because it may indicate an inflection point where the combination of local reference sites plus physician-to-physician referrals would accelerate device placements.

Equally important is the quality and distribution of these devices. WellMed and Walmart Canada not only contribute to the 1000 device goal, but they provide valuable references for us to leverage in the key market sectors of Managed Care and Retail Health. Viewed qualitatively, the Q2 device placements were a significant step up from the prior quarter.

The neurodiagnostics business contributed $1.6 million in revenue in Q2. This was down from $1.9 million in the first quarter of 2012. And of the $1.6 million in revenue, about $200,000 related to one-time sales from a technology upgrade program. The balance of $1.4 million was from recurring consumable shipments.

Looking forward, we face a challenging third quarter for two primary reasons. The first is that Managed Care and Retail Health sales are characterized by large deal values and corporate-to-corporate agreements. Sales cycles can be long and new account acquisition is likely to be uneven. They are difficult to predict. Secondly, neurodiagnostics historically faces the summer effects of reduced patient visits to their doctors, which leads to lower consumables purchases.

Moving on to our margins, our Q2 gross margin was 55.4%. This is down slightly from 56.8% in the second quarter of last year but it is an improvement from the 45.5% that we reported in Q1 of this year. That Q1 margin did include a charge of $157,000 that was related to inventory obsolescence. Excluding that charge, Q1 margins were 54% and so in comparison with what we're reporting here, we had an overall increase in the true margin.

Within overall gross margin, DPNCheck margins were 60% in the second quarter, and that was up significantly from 46% in Q1. It reflected the biosensor volume benefits of WellMed and Walmart as well as our initiative to increase the number of initial-order biosensors in the retail sales we make into endocrinology and podiatry. Neurodiagnostics margins were about 53% versus 56% in the first quarter of last year, excluding that Q1 inventory obsolescence charge.

In the second half of 2012, we expect overall gross margins to be in the 50% to 55% range. Our operating expenses totaled $4 million in Q2, an increase of $100,000 from the second quarter of last year and an increase of $300,000 from the first quarter of this year. OpEx in the second quarter of last year included a $200,000 asset impairment charge related to the discontinuation of a technology program. Taking this into account, the $300,000 increase in OpEx spending year on year is due to the addition of staff resources to support commercialization of NC-stat DPNCheck and, to a lesser degree, professional service costs in G&A. We expect operating expenses over the second half of this year to be in the range of $4 million per quarter and roughly in line with our Q2 spending.

Our net loss in Q2 was $2.8 million, or $0.22 a share based on a weighted average of 12.6 million shares outstanding. This compares with a loss of $2.4 million, or $0.63 a share in the second quarter last year where the weighted average share count was 3.9 million.

In terms of our balance sheet, we ended Q2 with $13.3 in million in cash and we had net cash usage of $1.9 million during the quarter. Cash usage within Q2 was favorably affected by a $500,000 reduction in working capital as we continue to draw down Accounts Receivable and inventory balances.

Going forward, our outlook is for working capital to remain flat or increase slightly due to the SENSUS launch. This should have the effect of increasing our quarterly cash usage into the range of $2.5 million to $2.7 million.

Those are the highlights. And Shai, back to you.

Thank you, Tom. Well, those are our prepared comments, and we'd be happy to take questions at this point.

(Operator Instructions). Juan Sanchez.

The question is on the SENSUS device. I know the filing is still at the FDA, but how will you qualify the regulatory risk on approval?

And the second question will be, how do you actually distribute a product like this? And probably more importantly, how do you create awareness so doctors and patients can use it?

Sure. Well, thank you for the questions. So, on the first question, on regulatory risk, I think it's fairly low. The nature of the questions we've had from the Agency have been straightforward, primarily relating to electrical safety issues. And we think we've been able to address those and we haven't seen any difficult questions. So we feel positive about that.

On the issue of distribution, as you know, this is a durable medical equipment product, so the distribution is somewhat more complex than a traditional product in that you need to work with both on the demand creation side, as you alluded to, and basically getting physicians to understand the product and to write prescriptions. Then you have to have one or more DME suppliers that can fulfill the order as well as do the billing.

So, we're looking at a variety of different solutions which include working with regional and/or national durable medical equipment suppliers, particularly those with some experience in the diabetes arena. There are many DME products in diabetes such as insulin pumps and glucose meters and so forth. We are particularly interested in DMEs that have some level of sales presence so they can help drive demand. We'll also be using our sales force to drive demand. So it's going to be a hybrid strategy that is still in its formative stages as we're in discussions right now with a variety of different DMEs, so we'll see how it comes together here. But we expect to have a variety of different distributors and a variety of different demand generation sources.

Okay, thank you, Shai.

Sure.

(Operator Instructions). I'm showing no questions at this time.

Okay. Well, thank you very much. We appreciate your participation in the conference call and look forward to updating you as we progress through the year. Thank you.

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.