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| NURO > SEC Filings for NURO > Form 10-K on 20-Mar-2009 | All Recent SEC Filings |
20-Mar-2009
Annual Report
You should read the following discussion of our financial condition and results of operations in conjunction with our selected financial data, our financial statements and the accompanying notes to those financial statements included elsewhere in this Annual Report on Form 10-K. This discussion contains forward-looking statements that involve risks and uncertainties. As a result of many factors, such as those set forth under the section titled "Risk Factors" and elsewhere in this Annual Report on Form 10-K, our actual results may differ materially from those anticipated in these forward-looking statements.
Overview
NeuroMetrix was founded in June 1996. We are a science-based medical device company advancing patient care through the development and commercialization of innovative products that aid physicians in the assessment, treatment, and repair of peripheral nerve and spinal cord injuries and disorders, and that provide regional anesthesia and pain control. To date, our focus has been on products that help physicians with the diagnosis or detection of neuropathies and neurovascular disorders. Neuropathies affect the peripheral nerves and parts of the spine and are frequently caused by or associated with CTS, diabetes, sciatica, and other clinical disorders. We market systems for the performance of nerve conduction studies and needle electromyography procedures.
We have two medical devices cleared by FDA that are used for the assessment of neuropathies. The first device is the ADVANCE™ NCS/EMG System a comprehensive platform for the performance of traditional nerve conduction studies and invasive electromyography procedures. This system is used primarily by neurologists, physical medicine and rehabilitation (PM&R) physicians, neurosurgeons, orthopedic and hand surgeons and pain medicine physicians. The ADVANCE System is a system for the performance of traditional nerve conduction studies and needle electromyography procedures. The ADVANCE System is comprised of: (1) single use surface electrodes and needles, (2) the ADVANCE device and related modules, and (3) a communication hub that enables the physician's office to network their device to our onCall Information System for data archiving, report generation and other network services. The second device is the NC-stat System, an automated device for the performance of nerve conduction studies. The NC-stat System, our first product for the assessment of neuropathies, has been sold historically to a broad group of physicians, including primary care physicians and specialists since its initial market launch in May 1999. The NC-stat System is comprised of: (1) disposable single use electrodes, (2) the NC-stat monitor and related components and (3) the NC-stat docking station, an optional device that enables the physician's office to transmit data to our onCall Information System. Our neurodiagnostic equipment is used in over five thousand physician offices, clinics and hospitals. Over one and a half million patients have been tested with our neurodiagnostic equipment since 1999.
We are presently focusing our sales efforts on the NC-Stat System to primary care physicians and clinics and the ADVANCE System primarily to specialist physicians with peripheral nerve expertise, including neurologists, physical medicine and rehabilitation (PM&R) physicians, neurosurgeons, orthopedic and hand surgeons and pain medicine physicians.
Substantially all of our revenues to date have been derived from sales of the NC-stat System. Due to reimbursement uncertainty described in further detail below, we are presently focusing our medical equipment sales efforts primarily on sales of the ADVANCE System to specialist physicians with peripheral nerve expertise. We continue to sell electrodes to and support our NC-stat System customer base, work with our existing NC-stat System customers in specialty practices to convert them to the ADVANCE System and provide solutions that enable our customers to provide this important diagnostic service to their patients.
Business Developments
Our revenues declined to $31.1 million for the twelve months ended December 31, 2008 compared to $43.7 million for the same period in 2007. Additionally, we incurred a net loss of $27.7 million for the twelve months ended December 31, 2008 compared to net loss of $8.4 million for the same period in 2007. We believe that the decline in our revenues has been caused primarily by the current environment relating to the reimbursement by third-party payers of nerve conduction studies performed using the NC-stat System and we expect that our revenues from sales of the NC-stat System may continue to be adversely affected by the uncertainty regarding reimbursement.
As of the year ended December 31, 2008, significant developments impacting and relating to our financial condition and results of operations which we expect to impact future periods, include:
º •
º Reimbursement developments relating to nerve conduction studies on our
revenues as described below, including the outcome of the CPT Panel
review of reimbursement coding for nerve conduction studies performed
using equipment such as the NC-stat System and the Medicare
reimbursement rate to be established for a potential new Category I
CPT Code for nerve conduction studies performed with pre-configured
electrode arrays, such as are utilized with the NC-Stat System.
º •
º The launch of the ADVANCE System, a system for the performance of
traditional nerve conduction studies and needle electromyography
procedures, which occurred in May 2008 following the 510(k) clearance
by the FDA. We are primarily focusing our sales and marketing efforts
for the ADVANCE System on specialist physicians with peripheral nerve
expertise, including neurologists, physical medicine and
rehabilitation physicians, neurosurgeons, orthopedic and hand surgeons
and pain medicine physicians in the United States.
º •
º The discontinuance of sales, support and marketing efforts for the
DigiScope effective November 1, 2008.
º •
º The reduction in the size of the sales force from 50 regional sales
managers to approximately 30 regional sales managers and certain other
cost reduction steps taken during the second quarter of 2008. These
steps were taken largely as a result of a decline in revenues we have
experienced. We expect that our operating expenses will be reduced by
approximately $5.0 million on an annualized basis, as a result of
these actions, compared to operating expense levels prior to these
actions being taken. In addition, our decision to terminate the
relationships with our independent sales agencies in the second half
of 2007, which we believe has adversely impacted our revenues, but has
resulted in the elimination of commissions on recurring revenues from
accounts originally sourced through our independent sales agencies.
Total commissions relating to independent sales agencies were $0 and
$3.0 million for the twelve months ended December 31, 2008 and 2007,
respectively. Our sales and marketing expenses have declined
$8.2 million in the twelve months ended December 31, 2008 as compared to the same period in 2007. We believe these cost reduction programs were the primary drivers.
º •
º The government investigations by the OIG and DOJ, that we were subject
to, which resulted in significantly increased legal expenses from
historical levels in 2007 and in the twelve months of 2008. On
February 9, 2009, the Company announced that it had reached a
resolution with the OIG and DOJ regarding the previously-mentioned
investigation into certain of the Company's past sales and marketing
practices relating to its NC-stat System.
For a more detailed description of the resolution, see the section titled "Legal Proceedings."
º •
º Continued progress developing a product designed to precisely deliver
pharmacologic agents such as anesthetics and corticosteroids in close
proximity to nerves for regional anesthesia, pain control and the
treatment of focal neuropathies such as CTS for which we have
submitted a 510(k) application to the FDA on the signal detector in
December 2008, and expect to file an application on the stimulator for
the device in the first quarter of 2009. We continue to invest
resources on the development of this product.
º •
º The investment we made in Cyberkinetics in the fourth quarter of 2007,
which included the purchase of $2.5 million of Cyberkinetics common
stock and the receipt of a warrant to purchase an additional
$1.25 million of Cyberkinetics common stock. We would have been
required to exercise the warrant if Cyberkinetics received FDA
approval of an HDE filing for the Andara OFS device for acute spinal
cord injuries by December 31, 2008, which they did not. Cyberkinetics,
in its Form 8-K filed on November 3, 2008, disclosed that its existing
cash and cash equivalents were only sufficient to meet their projected
operating requirements for approximately 30 days. As Cyberkinetics was
in the process of winding down operations, the value of the Company's
investment in Cyberkinetics was adversely affected. We believe that
this decline is not temporary in nature, and have therefore taken a
charge of $2.5 million to earnings for the decline in value through
December 31, 2008. We had entered into a joint venture with
Cyberkinetics for the development of a treatment for peripheral nerve
injury, for which we had committed to fund the first $2.0 million in
development expenses and 50% of any development costs exceeding the
initial $2.0 million. During the fourth quarter of 2008 the joint
venture with Cyberkinetics was dissolved which resulted in
deconsolidation of the entity from the consolidated financial
statements. In January 2009, we acquired certain technological and
intellectual property assets from Cyberkinetics for $350,000 in cash.
Reimbursement from third-party payers is an important element of success for medical device companies. As our presence in the market over the last several years has expanded with the use of the NC-stat System, physicians using NC-stat have experienced and may continue to experience an increased focus from third-party payers and governmental agencies regarding the reimbursement of nerve conduction studies performed using this device and an increased focus from these organizations regarding the professional requirements for performing nerve conduction studies in general. A number of third-party payers, including commercial payers, have taken and may continue to take the position of not reimbursing our customers for procedures performed using the NC-stat System.
During the second half of 2006 and in 2007, several local Medicare carriers issued draft local coverage determinations, or LCDs, final LCDs or coding articles particularly addressing coverage and reimbursement policies under Medicare for nerve conduction studies performed using the NC-stat System. Several of these carriers indicated that they will not reimburse physicians under Medicare for nerve conduction studies performed using the NC-stat System under the three existing Current Procedural Terminology, or CPT, codes for conventional nerve conduction studies (95900, 95903 and 95904), which provide for levels of reimbursement fixed by the CMS but rather that physicians must submit claims for reimbursement for these procedures under a miscellaneous CPT code (95999), in which case the local carriers may determine the level of reimbursement to be paid, if any. Currently,
there are four local Medicare carriers with final LCDs which address coverage and reimbursement policies under Medicare for nerve conduction studies performed using the NC-stat System. In certain regions impacted by these reimbursement decisions, our customers have experienced lower levels of reimbursement and higher levels of claims denials. If physicians do not receive adequate reimbursement under the miscellaneous CPT code from those local carriers, our existing customers may continue to limit or curtail their use of the NC-stat System and we may be unable to obtain new customers, both of which could materially and adversely impact our revenues and profitability.
The CPT Panel has been reviewing the reimbursement coding for nerve conduction studies and formed a work group in early 2007 to examine the reimbursement coding of nerve conduction studies performed using nerve conduction equipment, including the NC-stat System. The findings of this work group were presented to the CPT Panel at a meeting in February 2008. At this meeting, the CPT Panel approved a Category III code describing nerve conduction studies performed with pre-configured electrode arrays. However, prior to publishing a new Category III CPT code for nerve conduction studies, the CPT Panel decided to reconsider its decision. In October 2008, the CPT Panel again considered nerve testing as an agenda item and, at this meeting, approved a new Category I CPT code for nerve conduction studies performed with pre-configured electrode arrays, such as are utilized with the NC-stat System. This most recent decision was first made public in February 2009 when the CPT Panel released the final approved minutes from its October 2008 meeting. We expect that the new code will be published in the Federal Register in the second half of 2009 for implementation on January 1, 2010. Before this new CPT code is implemented, the amount of reimbursement that physicians will receive under the code will need to be determined. CMS will determine the RVUs on which the amount of reimbursement is based and publish the final RVUs in the Federal Register-usually in October for implementation January 1 the next year. This CPT code, when issued, may improve our customers' ability to submit claims efficiently and for these claims to be processed expeditiously and may help to stabilize the process for obtaining reimbursement under Medicare for nerve conduction studies performed using the NC-stat System.
The LCDs and coding articles issued by local Medicare carriers have also
addressed a number of other issues, including (1) the background and training of
physicians supervising or performing nerve conduction studies, (2) the level of
training requirements for technicians performing a nerve conduction study,
(3) whether nerve conduction tests should be required to be performed
concomitantly with a needle electromyography procedure and (4) whether the
NC-stat System is comparable to conventional nerve conduction testing equipment.
We do not believe that these LCDs prohibit physicians from receiving
reimbursement under Medicare for medically necessary nerve conduction studies
performed using the NC-stat System. However, these LCDs do appear to be targeted
at limiting access to perform and/or reimbursement for nerve conduction studies.
In certain cases, these LCDs are being interpreted or implemented in a manner
that impacts the ability of physicians to receive reimbursement under Medicare,
including lower levels of reimbursement and an increase in the number of claims
being denied, for nerve conduction studies performed using the NC-stat System,
which are having an adverse impact on our revenues.
Our success in selling the ADVANCE System will be dependent, among other things, on our customers' receiving, and our potential customers' belief that they will receive, sufficient reimbursement from third-party payers for performing procedures using the ADVANCE System. We do not believe that the final LCDs or policies adopted by major private payers impacting reimbursement for procedures performed using the NC-stat System will apply to procedures performed by specialists with peripheral nerve expertise using the ADVANCE System. However, these final LCDs and policies are subject to the interpretation of, and may be modified by, the applicable third-party payer, whose interpretations may differ from ours. Additionally, the outcome of the ongoing process with the CPT Panel regarding reimbursement coding of nerve conduction studies could impact future reimbursement of procedures performed using the ADVANCE System.
Additionally, a significant number of commercial payers, including the majority of regional Blue Cross Blue Shield carriers, and other major private payers, have adopted policies indicating that they will not provide reimbursement for the use of the NC-stat System. These commercial payers have cited various reasons for their reimbursement policies, including, among others, that the NC-stat System is experimental and investigational. We are in the process of communicating with these payers directly, through our customers or through our network of reimbursement consultants, to attempt to address their concerns. Third-party payers may also impose requirements on physicians to submit additional paperwork supporting the medical necessity of nerve conduction studies performed using the NC-stat System. We believe these requirements are negatively impacting the use of the NC-stat System by existing customers and our sales to new customers, both of which are having an adverse impact on our revenues.
Additional third-party payers, including local Medicare carriers and commercial payers, could potentially take a position that could reduce or eliminate the reimbursement for nerve conduction studies performed with the NC-stat System and could have the impact of deterring usage by our customers which could have an adverse impact on our revenues.
In the second quarter of 2008, we received 510(k) clearance from the FDA for the marketing in the United States of the ADVANCE System, a system for the performance of traditional nerve conduction studies and needle electromyography procedures. The ADVANCE System was cleared by the FDA with the primary predicate, or comparable, device being the Keypoint device originally manufactured and marketed by Medtronic, Inc. to neurologists and physical medicine and rehabilitation physicians for the performance of nerve conduction studies and needle electromyography procedures. The ADVANCE System is a traditional system that supports nerve conduction testing with any electrode methodology, real-time waveform review and cursor editing, needle electromyography procedures and conventional reports with the results of the testing. We launched our sales and marketing efforts for the ADVANCE System to specialists with peripheral nerve expertise such as neurologists, physical medicine and rehabilitation physicians, neurosurgeons, orthopedic and hand surgeons and pain medicine physicians in May 2008. Our success in selling the ADVANCE System will be dependent, among other things, on our customers' receiving, and our potential customers' belief that they will receive, sufficient reimbursement from third-party payers for performing procedures using the ADVANCE System. We do not believe that the final LCDs or policies adopted by major private payers impacting reimbursement for procedures performed using the NC-stat System will apply to procedures performed by specialists with peripheral nerve expertise using the ADVANCE System. However, these final LCDs and policies are subject to the interpretation of, and may be modified by, the applicable third-party payer, whose interpretations may differ from ours. Additionally, the outcome of the ongoing process with the CPT Panel regarding reimbursement coding of nerve conduction studies could impact future reimbursement of procedures performed using the ADVANCE System.
One of the primary challenges we face in our business is successfully expanding the market for nerve conduction studies and needle electromyography procedures. A successful market expansion will depend upon, in part, our targeting of specialist physicians with peripheral nerve expertise. Historically, our strategy had been to sell our neuropathy assessment systems through a combination of independent sales agencies and a direct sales force of experienced sales representatives. Due to a significant decline in the percentage of new customers being sourced through our independent sales agency network in 2007, we eliminated the independent sales agencies in the second half of 2007 and focused our selling efforts exclusively through our direct sales force. We believe the decision to terminate the independent sales agency relationships has contributed to the decline in revenues and could potentially have an adverse impact on our revenues and our ability to secure new customers in future periods as well.
We reduced the size of our direct sales force in the second quarter of 2008 to approximately 30 regional sales managers from the previous level of approximately 50 regional sales managers. We took this action to reduce our sales and marketing expenses as a result of the decline in revenues we have
experienced and due to our expectation that there will be further declines in
revenues over the next several quarters. This action resulted in a charge for
severance and benefit costs of $318,981 in the second quarter of 2008 and we
expect that this action, coupled with other cost reduction steps taken, will
reduce our operating expenses by approximately $5.0 million on an annualized
basis compared to operating expense levels prior to these actions being taken.
During the remainder of 2008, our direct sales force was primarily focused on
sales of our ADVANCE System to specialist physicians with peripheral nerve
expertise and on sales of electrodes to, and account management of, our existing
customer base. In March 2009, we reorganized our sales force into three market
segments: (1) neurology, which includes neurologists and PM&R physicians,
(2) neurointerventional, which includes neurosurgeons, orthopedic surgeons, pain
medicine physicians, and anesthesiologists, and (3) physician office, which
includes primary care physicians, internal medicine physicians,
endocrinologists, rheumatologists and occupational medicine physicians. We are
pursuing this realignment in order to effectively distribute and commercialize
our products as we continue to diversify our product offering. As a part of this
realignment, our vice president of sales departed March 4, 2009, and we are
looking to hire an experienced executive to oversee our overall sales function.
Our business is currently facing significant challenges and uncertainties and, as a result, our available capital resources may be consumed more rapidly than currently expected due to changes in our estimated future revenues, changes we make to our ongoing operating expenses, future changes in our business strategy, decisions we make regarding the size of our sales force and the magnitude of our sales and marketing programs, research and development spending plans and other items affecting our level of expenditures and our use of existing cash and cash equivalents and short-term investments. Accordingly, we may need to raise additional funds to support our operating and capital needs. Without additional funds, we may be forced to delay, scale back or eliminate some of our sales and marketing efforts, research and development activities or other operations and potentially delay our product development efforts. We may attempt to obtain additional funding through public or private financing, collaborative arrangements with strategic partners or through credit lines or other debt financing sources to increase the funds we have available to us to fund our operations. However, there are no assurances that we will be able to secure such financing on favorable terms, if at all.
Discontinued Operations
In December 2007, we acquired substantially all of the assets of EyeTel and their product, the DigiScope, a product used for the detection of eye disorders such as diabetic retinopathy, an eye disease prevalent in patients with diabetes for total consideration of approximately 1.1 million shares of our newly issued common stock and $175,000 in cash. Prior to acquiring EyeTel and during 2007, we had previously entered into an exclusive licensing agreement with EyeTel pursuant to which we had sales and marketing rights to the DigiScope in the primary diabetes care physician market. On September 30, 2008, as part of our ongoing focus on cost-efficiencies in all areas of our business, and our refocused efforts towards our core business, which is the sale of the ADVANCE System and support for our existing NC-stat System customers, we approved a plan for the closure of our facility in Columbia, Maryland and to discontinue sales and support of DigiScopes and DigiScope related services, effective November 1, 2008. On November 7, 2008, we sold substantially all of the assets related the DigiScope business to Advanced Diagnostics, LLC in exchange for assuming certain identified commitments of approximately $400,000 and a cash payment of $50,000. The CEO and President of Advanced Diagnostics, LLC is a former executive of ours who continues to receive payments under a separation agreement with us.
Net revenue, income (loss) from operations, and (loss) on sale for discontinued operations for the years ended December 31, 2008 and 2007 are as follows:
Years Ended December 31,
2008 2007
Net revenue $ 1,095,754 $ 954,935
Operating income (loss) from discontinued operations (1,999,937 ) 103,986
Loss on sale of discontinued operations (4,600,736 ) -
Net income (loss) from discontinued operations $ (6,600,673 ) $ 103,986
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Business Focus
Our long-term financial objectives are to grow our business through the sale of proprietary medical equipment and to achieve and sustain profitability. However, during 2009 our revenues are likely to remain flat or decrease from total revenues recognized in the year 2008, we are likely to continue to incur losses as a result of the reimbursement and other issues we are currently facing and there are no assurances that we will achieve these objectives over the longer term. We expect to focus our efforts for 2009 on (1) sales of the ADVANCE System to specialist physicians with peripheral nerve expertise, (2) sales of the NC-stat System, including sales of electrodes to, and on-going account management of, our existing NC-stat System customer base, (3) efforts to stabilize third-party reimbursement for procedures performed with the NC-stat System, (4) seeking regulatory clearance from the FDA for portions of the onCall Information System, and (5) our ongoing research and development programs.
Our launch of the ADVANCE System took place in May 2008 following 510(k) clearance by the FDA for marketing the ADVANCE System in the United States. In September 2008, we also received 510(k) clearance for our Universal Electrodes which are consumables designed to be used in conjunction with our ADVANCE System. During the fourth quarter of 2006, at the request of the FDA, we submitted a 510(k) filing relating to the onCall Information System which is currently in use. The 510(k) is still pending before the FDA. If 510(k) clearance for the portions of the onCall Information System that are under review is not obtained, it may require additional product development and potential changes in the configuration of the NC-stat System and onCall Information System, and the status of our currently distributed products using the onCall Information System may be uncertain. The portions of the onCall System under review through this 510(k) filing do not impact use of the ADVANCE System.
During 2009, we expect our research and development programs to (1) make . . .
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