What changed in this filing

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Item 1A. Risk Factors

2022-03-10 compared with 2021-03-11 · 257 added, 178 removed, 1215 unchanged (26% of the section changed)

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For example, we have limited access to our New Jersey office as a result of state-imposed restrictions.

Furthermore, the recent Biden administration's executive order requiring all on-site and remote federal employees, contractors and sub-contractors to be vaccinated against COVID-19 or receive an approved medical or religious exemption by December 8, 2021 may apply to us because of our Federal Supply Schedule Medical Equipment and Supply contract.

Failure to comply with the executive order could lead to loss of the contract, which could have a material adverse effect on our business, revenues, financial condition and result of operations.

In light of the executive order, we implemented a mandatory COVID-19 vaccination policy for all employees.

There are, however, ongoing challenges in the federal courts regarding the validity of the executive order, which could lead to future changes to our own policies depending on the outcome of those cases.

All of our U.S.

employees have to provide proof of vaccination sub ject to medical and religious exemptions.

To the extent an employee qualifies for a medical or religious exemption, we will collaborate with the exempt employee to explore reasonable accommodation options that may permit the employee to perform the essential functions of their job without being vaccinated.

We will be unable to accommodate an employee's exemption request if such accommodation would prevent an employee from performing the essential functions of their job, or would result in undue hardship, which includes, but not limited to, a risk of harm to others.

There can be no assurance that this policy or any future policies whether adopted in order to comply with applicable rules and regulations or otherwise will not have an adverse effect on our recruitment and retention of, and relations with our employees.

The coronavirus pandemic may also impact our ability to sell our product, ship our product on a timely basis and may increase our costs.

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Officially imposed quarantines and self-quarantines could also interfere with patients’ ability to see a health care provider and obtain our gammaCore therapy.

The degree to which coronavirus impacts our results will continue to depend on future developments that are highly uncertain and cannot be predicted, including, without limitation, the timing, extent, trajectory and duration of the pandemic, the development, rollout and availability of effective treatments and vaccines, the imposition of protective public safety measures, and how quickly and to what extent normal economic and operating conditions can resume, if at all.

The degree to which coronavirus impacts our results will continue to depend on future developments that are highly uncertain and cannot be predicted, including, without limitation, the timing, extent, trajectory and duration of the pandemic, the development, rollout and availability of effective treatments and vaccines, the imposition of protective public safety measures, vaccine mandates, the transmissibility and effects of new coronavirus variants such as those experienced with respect to the Omicron variant beginning in early December 2021, and how quickly and to what extent normal economic and operating conditions can resume, if at all.

These uncertainties may result in delays or modifications to our plans, initiatives and results.

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Developments related to coronavirus have been rapidly changing, and additional impacts and risks may arise that we are not aware of or able to appropriately respond to currently.

Our ability to market gammaCore Sapphire CV under the EUA may be adversely affected to the extent that (i) the coronavirus pandemic subsides, regardless of whether or not the EUA is terminated, revoked or expires, and (ii) other treatments or vaccines for coronavirus are developed and made available.

Furthermore, there are a number of preventative vaccines in development with two having received an Emergency Use Authorization approval and others potentially nearing regulatory approval.

Additionally, the United States and other countries around the world have recently begun to approve and commence distributing COVID-19 vaccines in their jurisdictions.

The broad distribution of COVID-19 vaccines may reduce demand for gammaCore Sapphire CV treatment as it may no longer be considered medically necessary.

More generally, in the future, our business, financial results, and financial condition may be negatively impacted by the effects of other disease outbreaks, epidemics, pandemics, or similar widespread public health concerns.

Risk Related to our Financial Position, Operating Results and Need for Additional Capital

We recently launched new cash pay initiatives, including our gConcierge and gCDirect programs, and patients and providers may be slow to adopt these programs or their pricing which could adversely impact our business and financial results.

We currently have a small cash-pay business channel, which includes the recently launched e-commerce websites for our gConcierge and gCDirect programs, and intend to expand our direct-to-consumer business channel by increasing our advertising and promotional activities in 2022.

This will require significant investment and expansion of our sales and marketing capabilities and further development by us and third parties of telehealth features relating to this business channel.

We have limited experience with scaling and commercializing a direct-to-consumer cash-pay business channel in the United States and abroad, which may impact our ability to rely on this channel as a positive source of revenue.

If we are unsuccessful in executing our commercialization efforts in this business channel and do not achieve the sales levels that we expect, we will be unable to recover these investments.

Additionally, there is a risk that potentially lower pricing of our therapy in the direct-to-consumer cash-pay business channel could lead to lower pricing and reimbursement in our legacy business channels and, therefore, have an adverse impact on our financial position and results of operations, and heighten our need to obtain additional capital to support our business.

If third-party payers do not provide adequate coverage and reimbursement for the use of gammaCore, it may affect our ability to generate significant revenues.

Some of our success in marketing and commercializing gammaCore depends and will continue to depend on whether U.S.

and international government health administrative authorities, private health insurers and other payer organizations provide adequate coverage and reimbursement for the cost of our products.

Many third-party payers do not currently cover VNS for any indications other than epilepsy because they have determined all other VNS modalities to be investigational or experimental.

If physicians or insurers do not find our clinical data compelling or wish to wait for additional studies, they may choose not to use or provide coverage and reimbursement for gammaCore.

We cannot provide assurance that data we or others may generate in the future will be consistent with that observed in our existing clinical studies, or that our current or future published clinical evidence will be sufficient to obtain adequate coverage and reimbursement for our products.

Moreover, if we cannot obtain adequate coverage for and reimbursement of the cost of our products, we cannot provide assurance that patients will be willing to incur the full cost of our gammaCore therapy.

In the United States, we expect to derive nearly all of our sales from prescriptions of gammaCore written by physicians.

Access to adequate coverage and reimbursement by third-party payers for our gammaCore therapy or the willingness of patients to bear the entire cost of our therapy is essential in the acceptance of our products by physician, patients and other customers for our therapy.

Third-party payers, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs.

In addition, in the United States, no uniform policy of coverage and reimbursement for our gammaCore therapy exists among third-party payers.

Therefore, coverage and reimbursement for our gammaCore therapy can differ significantly from payer to payer.

In addition, payers continually review new technologies for possible coverage and can, without notice, deny coverage for these new products and procedures.

As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our gammaCore therapy to each payer separately, with no assurance that coverage and adequate reimbursement will be obtained or maintained if obtained.

Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtained on a country-by-country basis.

In many international markets, a product must be approved for reimbursement before it can be approved for sale in that country.

Further, many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures.

In most markets, there are private insurance systems as healthcare systems that control reimbursement for new devices and procedures.

In most markets, there are private insurance systems as well as government-managed systems.

If sufficient and timely coverage and reimbursement is not available for our current or future products or if reimbursement rates change, in either the United States or internationally, the demand for our product and our revenues will be adversely affected.

We have a limited history commercializing our gammaCore therapy through direct-to-consumer channels and commercial success is uncertain.

As a small company with a limited history of selling our gammaCore therapy and which has primarily focused on physician adoption and commercial payer and government sales channel to date, we have limited experience engaging in direct-to-consumer commercial activities and limited established relationships with marketing agencies, analytic platforms, and social media following, all of which is becoming increasingly important to direct-to-consumer initiatives.

We may be unable to gain broader market acceptance in direct-to-consumer channels of gammaCore therapy in the United States or abroad for a number of reasons, including:

established competitors with strong relationships with customers, including ecommerce and telehealth platforms, systems, marketing agencies and a critical mass of existing patients ;

limitations in our ability to demonstrate differentiation and advantages of our product compared to competing products and the relative safety, efficacy and ease of use of our product;

the limited size of our marketing team and the learning curve required to gain experience selling our product direct-to-consumer;

insufficient financial or other resources to support our commercialization efforts necessary to reach profitability;

the introduction and market acceptance of new, more effective or less expensive competing products and technologies.

Any significant disruption to our e-commerce business could result in lost sales.

We recently launched new cash pay initiatives for our gammaCore therapy, including our e-commerce websites in both the United States and United Kingdom.

Online sales are subject to a number of risks.

System interruptions or delays could cause potential patients to fail to purchase our products and could harm our brand.

The operation of our direct-to-consumer ecommerce business depends on our ability to maintain the efficient and uninterrupted operation of online prescription generation, order-taking and fulfillment operations.

Our ecommerce operations subject us to certain risks that could have an adverse effect on our operating results, including risks related to the computer systems that operate our website and related support systems, such as system failures, viruses, denial of service attacks, computer hackers, data privacy breaches and other disruptions.

If we are unable to continually add software and hardware, effectively upgrade our systems and network infrastructure and take other steps to improve the efficiency of our systems, system interruptions or delays could occur that would adversely affect our operating results.

We utilize third-party vendors for our customer-facing ecommerce technology, portions of our prescription generation, order management system, and fulfillment internationally.

We depend on our technology vendors to manage "up-time" of the front-end ecommerce store, manage regulatory control measures around prescriptions, the intake of our orders, and export orders for fulfillment.

Any failure on the part of our third-party ecommerce vendors or in our ability to transition third-party services effectively could result in lost sales and harm our business.

We are subject to increasing operating costs and inflation risks which may adversely affect our performance.

While we may attempt to offset potential increases in operating costs through a variety of measures focused on increasing revenues or reducing operating expenses, there is no assurance that we will be able to do so.

Therefore, operating costs may rise faster than associated revenues resulting in a material negative impact on our cash flow and margins.

We are also impacted by inflationary increases in wages and benefits whether driven by competition for talent or ordinary course pay increases, as well as other rising costs.

Increases in the rate of inflation could also significantly impact our cost base.

In all countries in which we operate, wage inflation, whether driven by competition for talent or ordinary course pay increases, may also increase the cost of our cost products and reduce our profitability if we are not able to pass those costs on to our patients and consumers or charge premium prices when justified by market demand.

We have a history of significant losses.

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To become and remain profitable, we must successfully commercialize our gammaCore therapy and continue to identify promising new areas of treatment with significant market potential.

This will require us to be successful in a range of challenging activities, which may include obtaining adequate coverage and reimbursement from payers, marketing and selling any current and future product candidates for which we may obtain marketing clearance, approval or authorization, developing commercial scale manufacturing processes, completing future clinical trials of gammaCore for additional therapeutic indications, obtaining additional marketing clearance, approval or authorization from regulatory authorities, manufacturing, and satisfying any post-marketing requirements.

We face a variety of challenges and risks that we will need to address and manage as we pursue our strategy, including our ability to achieve adequate payer coverage, develop and retain an effective sales force, achieve market acceptance of gammaCore among physicians, patients and third-party payers, and expand the use of gammaCore to additional therapeutic indications.

We face a variety of challenges and risks that we will need to address and manage as we pursue our strategy, including our ability to achieve adequate payer coverage, develop and retain effective sales force and marketing personnel, achieve market acceptance of gammaCore among physicians, patients and third-party payers, and expand the use of gammaCore to additional therapeutic indications.

Because of the numerous risks and uncertainties associated with our commercialization efforts, as well as research and clinical development activities, we are unable to predict the timing or amount of increased expenses, or when, if ever, we will be able to achieve or maintain profitability.

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and UK commercial infrastructure.

Even if we are able to increase sales of gammaCore, increase adoption of gammaCore therapy among physicians, payers, and patients and achieve desired payer coverage levels, we may not achieve profitability and even if we do, we may not be able to sustain or increase profitability in subsequent periods.

We expect to continue to incur substantial net losses and negative cash flows from operations as we commercialize gammaCore.

Even if we are able to increase sales of gammaCore, increase adoption of gammaCore therapy among physicians, payers, patients, and consumers and achieve desired payer coverage and reimbursement levels and increased consumer demand, we may not achieve profitability and even if we do, we may not be able to sustain or increase profitability in subsequent periods.

If we fail to become profitable or are unable to sustain profitability, then we may be unable to continue our operations at planned levels and be forced to further reduce or terminate our operations.

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There can be no assurance that we will have sufficient cash flow and liquidity to fund our planned activities, which could force us to significantly reduce or curtail our activities and ultimately, potentially cease operations.

Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.

Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development, and marketing efforts, expand our business or continue our operations.

A decline in the value of our company also could cause you to lose all or part of your investment.

We will be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all, which could impair our ability to continue as a going concern.

Our operations have consumed substantial amounts of cash since inception, and we anticipate this continuing for at least the next 12 months as we continue seeking to invest in our business.

Our plans to expand our direct-to-consumer cash-pay business channel may not be able to generate significant revenues.

We currently have a small direct-to-consumer cash-pay business channel, which we are planning to expand in 2022 and beyond.

This will require significant investment in and expansion of our sales and marketing capabilities and use of third-party telehealth providers or development of our own telehealth platform.

If we are unsuccessful in executing our commercialization efforts in this business channel and do not achieve the sales levels that we expect, we may be unable to recover these investments.

Additionally, there is a risk that expanding our direct-to-consumer cash-pay business channel could depress pricing with third-party payers and, therefore, have an adverse impact on our results of operations.

We must successfully attract, hire, train and retain qualified professionals to service our direct-to-consumer sales channels and we must productively deploy our professionals to become profitable.

Identifying, recruiting, hiring and retaining professionals, including employees, independent contractors and consultants with diverse skill sets across our broad geography of operations, and consistent with servicing our existing, new and evolving sales channels, direct-to-consumer is critical to our sales strategy.

The market for qualified professionals is evolving, dynamic and increasingly challenging.

Our corporate reputation is a significant factor consumers’ evaluation of whether to buy our products or potential employees’ evaluation of whether to join our company.

If we are unable to recruit skilled professionals and if we do not deploy those professionals productively, our results of operations may be adversely impacted.

We must manage our sales and marketing team well and plan and train for future needs effectively while accurately predicting physician, patient, and consumer demand.

We may not be able to retain such talented professionals long-term for a variety of reasons including their desire to remain as independent content creators rather than full-time employees.

If we are unable to attract, hire, train and retain highly skilled professionals and productively deploy them on our sales and marketing efforts, we will jeopardize our ability to develop ongoing and future sales, which could adversely affect our financial condition and results of operations.

Competition for highly skilled professionals is intense in the markets where we operate, and we may experience significant employee turnover rates due to such competition.

If we are unable to retain professionals with specialized skills, our revenues, operating efficiency and profitability will decrease.

Cost reductions, such as reducing headcount, or voluntary departures that result from our failure to retain the professionals we hire, could negatively affect our reputation as an employer and our ability to hire skilled professionals to meet our business requirements.

Increased compensation to retain skilled professionals could lead to lower margins or to higher costs and price increases that may in turn lead to a decline in demand for our products.

Any significant growth in the market for our products and services or our entry into a new market may require an expansion of our employee base for managerial, marketing, operational, financial and other purposes.

During any period of growth, we may face problems related to our operational and financial systems and controls, including quality control and delivery and service capacities.

We would also need to continue to expand, train and manage our employee base.

Continued future growth will impose significant added responsibilities upon the members of management to identify, recruit, maintain, integrate and motivate new employees.

If we experience price fluctuations for our products and we are unable to reduce our expenses, including the per unit cost of producing our products, there may be a material adverse effect on our business, results of operations, financial condition and cash flows.

We anticipate that we will experience, price fluctuations for our products due to pricing pressure relating to our efforts to drive consumer demand.

We may also face pricing pressure from managed care organizations and other third-party payors due to increased market power of our payors as the medical device industry consolidates, and increased competition among suppliers, including manufacturing services providers.

If the prices for our products decrease and we are unable to reduce our expenses, including the cost of sourcing materials, logistics and the cost to manufacture our products, our sales , results of operations, financial condition and cash flows will be adversely affected.

The global COVID-19 pandemic may result in increased costs for manufacturing and outsourced services while also causing additional pressure to reduce the prices for our products if a recession or depression occurs and people are unable to afford our products.

We cannot predict the ultimate impact that the COVID-19 pandemic and its effects could have on our business operations, financial condition and cash flows.

Any increased or unexpected pricing pressures, costs, delays or failures to achieve cost savings, or unexpected risks we encounter in our business, including those caused by factors outside our control, could adversely affect our business, results of operations, financial condition and cash flows.

Future acquisitions, strategic investments or alliances could disrupt our business and harm our business, financial condition and operating results.

We may in the future explore potential acquisitions of companies or technologies, strategic investments, or alliances to strengthen our business.

Acquisitions involve numerous risks, any of which could harm our business, including:

regulatory hurdles;

anticipated benefits may not materialize;

cultural challenges associated with integrating employees from the acquired company into our organization;

integration of the acquired company's products and technology;

integration of the acquired company's accounting, management information, human resources and other administrative systems;

the need to implement or improve controls, procedures and policies at a business that prior to the acquisition may have lacked effective controls, procedures and policies;

coordination of product development and sales and marketing functions;

liability for activities of the acquired company before the acquisition, including relating to privacy and data security, patent and trademark infringement claims, violations of laws, commercial disputes, tax liabilities and other known and unknown liabilities;

litigation or other claims in connection with the acquired company, including claims from terminated employees, users, former stockholders or third parties.

Failure to appropriately mitigate these risks or other issues related to such acquisitions and strategic investments could result in reducing or completely eliminating any anticipated benefits of transactions, and harm our business generally.

Future acquisitions could also result in dilutive issuances of our equity securities, the incurrence of debt, contingent liabilities, amortization expenses or the impairment of goodwill, any of which could harm our business, financial condition and operating results.

We will be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.

Our operations have consumed substantial amounts of cash since inception, and we anticipate this continuing for at least the next 12 months from the date the financial statements included in this Annual Report are made available as we continue seeking to invest in our business.

We believe that our growth will depend, in part, on our ability to fund our commercial efforts for our gammaCore therapy, and to opportunistically pursue research and development activities for additional indications for our gammaCore therapy.

Our existing resources are unlikely to allow us to conduct all of the activities that we believe could be beneficial for our future growth.

As a result, we may need to seek additional funds in the future or curtail or forgo some or all of such activities.

As a result, we will need to seek additional funds in the future or curtail or forgo some or all of such activities.

If we seek to and are unable to raise funds on favorable terms, or at all, we may not be able to support our commercialization efforts or increase our research and development activities and the growth of our business may be negatively impacted.

As a result, we may be unable to compete effectively.

Although we expect that our existing capital resources and cash flow, will enable us to fund the operating expenses and capital expenditure requirements of our current operating plan for 12 months, this estimate is based on assumptions that may prove to be wrong, and we could exhaust or significantly diminish our available capital resources sooner than we expect.

Although we expect that our existing capital resources and cash flow, will enable us to fund the operating expenses and capital expenditure requirements of our current operating plan for at least the next 12 months from the date the financial statements included in the Annual Report are made available, this estimate is based on assumptions that may prove to be wrong, and we could exhaust or significantly diminish our available capital resources sooner than we expect.

Changes, including those relating to the payer and competitive landscape, our commercialization strategy, our development activities and regulatory matters, may occur beyond our control that would cause us to consume our available capital more quickly.

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the outcome, timing of, and costs involved with our plan to potentially expand our direct-to-consumer cash-pay business channel;

the outcome, timing of, and costs involved in, making gammaCore Sapphire CV available pursuant to the EUA to facilitate its study and clinical use for the acute treatment of asthma exacerbations in known or suspected COVID-19 patients;

the scope and timing of our investment in our U.S.

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the need for us and third parties, including payers and service providers, to potentially need to implement new or revised policies, infrastructure and internal systems;

our ability to hire additional personnel to support our operations, including as a public company;

our ability to hire additional personnel to support our operations;

the emergence and acceptance of competing therapies or other adverse market developments.

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Our failure to obtain additional necessary financing could impair our ability to conduct our operations, and any such failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to (i) pursue our business plans and strategies and (ii) maintain our listing on the Nasdaq Stock Market.

In addition, our auditors’ report for our 2020 financial statements contains a statement concerning our ability to continue as a “going concern.” Our lack of sufficient liquidity could make it more difficult for us to secure additional financing terms acceptable to us, if at all, and may materially and adversely affect the terms of any financing that we may obtain and our stock price generally.

Our continuation as a “going concern” is dependent upon, among other things, our ability to increase revenue, reduce operating expenses and obtain additional funding through the sale of equity and or debt securities, debt financing, a strategic transaction or otherwise.

Our lack of sufficient liquidity could make it more difficult for us to secure additional financing terms acceptable to us, if at all, and may materially and adversely affect the terms of any financing that we may obtain and our stock price generally.

Our ability to continue our operations depends upon, among other things, our ability to increase revenue, reduce operating expenses and obtain additional funding through the sale of equity and or debt securities, debt financing, a strategic transaction or otherwise.

However, there are significant risks and uncertainties as to our ability to achieve these goals or obtain required funding on commercially reasonable terms or at all, including as a result of the adverse impact on our business from the COVID-19 pandemic.

Due to these risks and uncertainties, we may need to reduce our activities significantly more than our current operating plan and cash flow projections assume in order to fund operations for at least the next 12 months.

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While the adoption of the new standards will not change the cash flows, we receive from our contracts with customers, the changes to our reporting practices and the potential fluctuations in our reported results could cause a decline and/or fluctuation in the price of our common stock.

Changes in certain areas of our business have resulted in the adoption of new accounting principles.

Our evolving commercial strategy has resulted in the launch of cash pay models which under GAAP will lead to the cost of our goods being treated as licensed products pursuant to which the licensed starter kit will be classified as an "other asset" on the company's balance sheet and the cost of the starter kit will be recognized over the license period based on the estimated useful life of the kit, while the cost of goods sold related to the therapy will be expensed upon shipment.

This change results in a different accounting methodology which may affect the value of assets on our balance sheet.

The new accounting practices could cause our results of operations to have greater variability due to the impact of changes on the estimated recoverability of such asset values.

In addition, licensed product accounting is based off a series of useful life assumptions that may prove to be inaccurate and will be subject to change from time to time, all of which can result in fluctuations from period to period for balance sheet items and have a related impact on our results of operations.

Risks Related to Our Business and the Development of Our gammaCore Therapy

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Additionally, we may have to incur targeted marketing and other expenditures to achieve sales of the gammaCore Sapphire CV.

We have no experience with commercializing a respiratory product in the United States.

We have limited experience with commercializing a respiratory product in the United States.

We did not recognize material revenue from sales of our gammaCore Sapphire CV during the fiscal year ended December 31, 2021.

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As a result of these and other significant challenges and uncertainties, there can be no assurance as to what impact, if any, the EUA will have on us, our business, operations or financial condition.

Commercializing our gammaCore Sapphire CV therapy for the acute treatment of asthma exacerbations in known or suspected COVID-19 patients may require targeted investment in research and development and expansion of our sales and marketing capabilities.

We may need to make targeted investments in research and development and expansion of our sales and marketing, distribution, and telehealth capabilities in order to commercialize gammaCore Sapphire CV therapy for the acute treatment of asthma exacerbations in known or suspected COVID-19 patients.

If we are unsuccessful in our commercialization efforts and do not achieve the sales levels that we expect, we may be unable to recover these investments in research and development, sales and marketing, distribution and telehealth efforts, and our business and financial condition could be materially adversely affected.

Our plans to potentially expand our direct-to-consumer cash-pay business channel may not be able to generate significant revenues.

We currently have a small direct-to-consumer cash-pay business channel, which we are planning to potentially expand in the near future.

This may require significant investment in and expansion of our sales and marketing capabilities and development of a telehealth platform.

If we are unsuccessful in executing our commercialization efforts in this business channel and do not achieve the sales levels that we expect, we may be unable to recover these investments.

If third-party payers do not provide adequate coverage and reimbursement for the use of gammaCore, we may be unable to generate significant revenues.

Our success in marketing and commercializing gammaCore depends and will depend in large part on whether U.S.

and international government health administrative authorities, private health insurers and other payer organizations provide adequate coverage and reimbursement for the cost of our products.

Many third-party payers do not currently cover VNS for any indications other than epilepsy because they have determined all other VNS modalities to be investigational or experimental.

If physicians or insurers do not find our clinical data compelling or wish to wait for additional studies, they may choose not to use or provide coverage and reimbursement for gammaCore.

In the United States, we expect to derive nearly all of our sales from prescriptions of gammaCore written by physicians.

Access to adequate coverage and reimbursement by third-party payers for our gammaCore therapy is essential to the acceptance of our products by customers and patients, because without such coverage and reimbursement, customers and patients will have to be willing to bear the entire cost of our therapy.