(Mark One)
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ý
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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04-3308180
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.)
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4B Gill Street, Woburn, Massachusetts
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01801
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(Address of Principal Executive Offices)
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(Zip Code)
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Title of each class
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Name of exchange on which registered
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Common Stock, $0.0001 par value per share
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The Nasdaq Stock Market LLC
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Preferred Stock Purchase Rights
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The Nasdaq Stock Market LLC
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Warrants to Purchase Common Stock
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The Nasdaq Stock Market LLC
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company x
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Emerging growth company o
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PART I
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PART II
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PART III
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PART IV
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•
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Point-of-care neuropathy diagnostic tests
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•
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Wearable neurostimulation devices
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Product
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Time on Market
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Technology
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Primary Clinical Indications
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No. Patients
Tested/Treated
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Quell
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Q2 2015 – present
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Transcutaneous Electrical Nerve Stimulation
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Symptomatic relief of chronic, intractable pain (OTC)
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> 200,000
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SENSUS
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Q1 2013 – present
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Transcutaneous Electrical Nerve Stimulation
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Symptomatic relief of chronic, intractable pain (prescription)
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> 11,000
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DPNCheck
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Q4 2011 – present
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Nerve Conduction
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Diagnosis and evaluation of peripheral neuropathies, such as DPN
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> 1,300,000
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ADVANCE
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Q2 2008 – present
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Nerve Conduction
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Diagnosis and evaluation of CTS, low back pain, peripheral neuropathies (including DPN)
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> 1,900,000 (ADVANCE and NC-stat)
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NC-stat
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Q2 1999 – Q3 2010
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Nerve Conduction
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Diagnosis and evaluation of CTS, low back pain, peripheral neuropathies (including DPN)
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•
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DPNCheck Generation 2. DPNCheck, our quantitative nerve conduction test for peripheral neuropathies including DPN, has been on the market since 2011 without any significant engineering changes. While the product has performed well and we believe that demand is growing, some features need to be added to improve the user experience, improve the manufacturing process, and restrict the potential use of non-compliant biosensors. This technology upgrade will be a primary R&D activity during 2020.
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•
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Quell R&D. During 2020 Quell engineering support will be provided to the GSK product launch efforts in markets outside the U.S. Also, certain product modifications jointly agreed and co-funded with GSK may be undertaken. We will also investigate additional clinical applications for the Quell platform.
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•
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Support clinical studies for our wearable technology. We plan to continue to build the body of evidence from clinical studies that is foundational to Quell and supports our marketing efforts.
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•
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Class I, the lowest risk products, which require compliance with medical device general controls, including labeling, establishment registration, device product listing, adverse event reporting and, for some products, adherence to good manufacturing practices through the FDA’s quality system regulations;
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•
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Class II, comprising moderate-risk devices, which also require compliance with general controls and in some cases, so-called special controls that may include performance standards, particular labeling requirements, or post-market surveillance obligations; typically a Class II device also requires pre-market review and clearance by FDA of a pre-market notification (also referred to as a “510(k) application”) as well as adherence to the quality system regulations/good manufacturing practices for devices; and
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•
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Class III, high-risk devices that are often implantable or life-sustaining, which also require compliance with the medical device general controls and quality system regulations, but which generally must be approved by FDA before entering the market, through a more lengthy pre-market approval (PMA) application. Approved PMAs can include post-approval conditions and post-market surveillance requirements, analogous to some of the special controls that may be imposed on Class II devices.
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•
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the FDA’s QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other good manufacturing practice and quality assurance procedures during all aspects of the manufacturing process (unless a device category is exempt from this requirement by the FDA, such as in the case of many Class I devices);
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•
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labeling regulations and FDA prohibitions against the promotion of products for uncleared or unapproved uses (known as off-label uses), as well as requirements to provide adequate information on both risks and benefits;
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•
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medical device reporting regulations, which require that manufacturers report to FDA any event that the company learns of in which a device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur;
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•
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correction and removal reporting regulations, which require that manufacturers report to the FDA field corrections and device recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA caused by the device that may present a risk to health;
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•
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post-market surveillance regulations, which apply to Class II or III devices if the FDA has issued a post-market surveillance order and the failure of the device would be reasonably likely to have serious adverse health consequences, the device is expected to have significant use in the pediatric population, the device is intended to be implanted in the human body for more than one year, or the device is intended to be used to support or sustain life and to be used outside a user facility;
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•
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regular and for-cause inspections by FDA to review a manufacturer’s facility and its compliance with applicable FDA requirements; and
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•
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the FDA’s recall authority, whereby it can ask, or order, device manufacturers to recall from the market a product that is in violation of applicable laws and regulations.
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•
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MDSAP Members
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◦
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Therapeutic Goods Administration of Australia
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◦
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Brazil’s Agência Nacional de Vigilância Sanitária
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Health Canada
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Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
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U.S. Food and Drug Administration
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•
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MDSAP Official Observers:
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◦
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The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme
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European Union (EU)
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•
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MDSAP Affiliate Members: (New)
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◦
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Republic of Korea's Ministry of Food and Drug Safety
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•
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inability to increase adoption of DPNCheck within the Medicare Advantage market and Outside the United States (OUS) markets;
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•
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regulatory inquiries or issues affecting our products;
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unfavorable changes to current Medicare, Medicare Advantage and commercial payer payment policies;
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changes to payor policies under the Patient Protection and Affordable Care Act;
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inability to efficiently create market demand for Quell at profitable pricing and efficient digital marketing;
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manufacturing issues with Quell or our other products;
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unfavorable experiences by patients and physicians using DPNCheck, Quell and our other products; and,
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physicians’ or patients' reluctance to alter their existing practices and adopt the use of our devices.
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warning letters, untitled letters, fines, injunctions, product seizures, consent decrees and civil penalties;
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requiring repair, replacement, refunds, customer notifications or recall of our products;
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imposing operating restrictions, suspension or shutdown of production;
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refusing our requests for 510(k) clearance or PMA approval of new products, new intended uses, or modifications to existing products;
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requesting voluntary rescission of 510(k) clearances or withdrawing PMA approvals that have already been granted; and
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criminal prosecution.
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lower than expected manufacturing yields of high cost components leading to increased manufacturing costs;
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shortages of electric components resulting in higher prices or an inability to supply key parts;
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low production volume which will result in high levels of overhead cost per unit of production;
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the timing of revenue recognition and revenue deferrals;
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increased material or labor costs;
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increased service or warranty costs or the failure to reduce service or warranty costs;
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increased price competition;
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variation in the margins across products in a particular period; and
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how well we execute on our strategic and operating plans.
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the pending patent applications we have filed or to which we have exclusive rights may not result in issued patents or may take longer than we expect to result in issued patents;
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the claims of any patents that are issued may not provide meaningful protection;
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we may not be able to develop additional proprietary technologies that are patentable;
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other parties may challenge patents, patent claims or patent applications licensed or issued to us; and
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other companies may design around technologies we have patented, licensed or developed.
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the agreements may be breached or not enforced in a particular jurisdiction;
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we may have inadequate remedies for any breach;
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trade secrets and other proprietary information could be disclosed to our competitors; or
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others may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose such technologies.
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assert claims of infringement;
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enforce our patents;
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protect our trade secrets or know-how; or
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determine the enforceability, scope and validity of the proprietary rights of others.
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loss of customer orders and delay in order fulfillment;
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damage to our brand reputation;
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increased cost of our warranty program due to product repair or replacement;
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inability to attract new customers;
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•
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diversion of resources from our manufacturing and research and development departments into our service department; and
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legal action.
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properly identify customer needs;
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prove feasibility of new products in a timely manner;
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educate physicians about the use of new products and procedures;
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comply with internal quality assurance systems and processes timely and efficiently;
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comply with regulatory requirements relating to our products, and limit the timing and cost of obtaining required regulatory approvals or clearances;
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accurately predict and control costs associated with inventory overruns caused by phase-in of new products and phase-out of old products;
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price new products competitively;
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manufacture and deliver our products in sufficient volumes on time, and accurately predict and control costs associated with manufacture of the products; and
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meet our product development plan and launch timelines.
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greater resources for product development, sales and marketing;
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more established distribution networks;
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greater name recognition;
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more established relationships with health care professionals, customers and third-party payers; and
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additional lines of products and the ability to offer rebates or bundle products to offer discounts or incentives.
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failure to fulfill foreign regulatory requirements, if applicable, to market our products;
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availability of, and changes in, reimbursement within prevailing foreign health care payment systems;
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adapting to the differing business practices and laws in foreign countries;
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difficulties in managing foreign relationships and operations, including any relationships that we establish with foreign distributors or sales or marketing agents;
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•
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limited protection for intellectual property rights in some countries;
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•
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difficulty in collecting accounts receivable and longer collection periods;
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•
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costs of enforcing contractual obligations in foreign jurisdictions;
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•
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recessions in economies outside of the United States;
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•
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political instability and unexpected changes in diplomatic and trade relationships;
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•
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currency exchange rate fluctuations; and
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potentially adverse tax consequences.
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incur additional indebtedness;
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create liens;
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•
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replace certain of our executive officers;
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enter into transactions with affiliates;
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transfer assets;
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pay dividends or make distributions on, or repurchase, our capital stock; and
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merge or consolidate.
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the outcome of the FTC Civil Investigative Demand initiated in 2017;
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the outcome of potential asset divestitures;
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the achievement of GSK commercialization milestones;
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•
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the denial or delay of regulatory clearances or approvals for our products under development or receipt of regulatory approval of competing products;
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our ability to accomplish clinical, regulatory and other product development and commercialization milestones and to do so in accordance with our timing estimates;
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•
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changes in policies affecting third-party coverage and reimbursement in the United States and other countries;
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•
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changes in government regulations and standards affecting the medical device industry and our products;
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•
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ability of our products to achieve market success;
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•
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the performance of third-party contract manufacturers and component suppliers;
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•
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actual or anticipated variations in our results of operations or those of our competitors;
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•
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announcements of new products, technological innovations or product advancements by us or our competitors;
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•
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developments with respect to patents and other intellectual property rights;
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•
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sales of common stock or other securities by us or our stockholders in the future;
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•
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additions or departures of key scientific or management personnel;
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disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
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•
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trading volume of our common stock;
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•
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regulatory inquiries or developments affecting our products;
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•
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changes in earnings estimates or recommendations by securities analysts, failure to obtain or maintain analyst coverage of our common stock or our failure to achieve analyst earnings estimates;
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•
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public statements by analysts or clinicians regarding their perceptions of our clinical results or the effectiveness of our products;
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•
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decreases in market valuations of medical device companies; and
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•
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general market conditions and other factors unrelated to our operating performance or the operating performance of our competitors.
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•
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authorize the issuance of preferred stock which can be created and issued by the Board of Directors without prior stockholder approval, with rights senior to those of our common stock;
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provide for a classified Board of Directors, with each director serving a staggered three-year term;
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prohibit our stockholders from filling board vacancies, calling special stockholder meetings, or taking action by written consent;
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provide for the removal of a director only with cause and by the affirmative vote of the holders of 75% or more of the shares then entitled to vote at an election of our directors; and
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•
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require advance written notice of stockholder proposals and director nominations.
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Number of
securities to be
issued upon
exercise of
outstanding
options, warrants
and rights
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Weighted average
exercise price of
outstanding
options, warrants
and rights
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Number of
securities remaining
available for future
issuance under
equity
compensation plans
(excluding
securities reflected
in column a)
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||||||
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(a)
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(b)
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(c)
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||||||
Equity compensation plans approved by security holders(1)
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164,980
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$
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7.16
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261,356
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(2)
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Equity compensation plans not approved by security holders(3)
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—
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—
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1,250
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|
|
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Totals
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164,980
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|
|
$
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7.16
|
|
|
262,606
|
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(1)
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Includes information related to our Amended and Restated 1996 Stock Option/Restricted Stock Plan, Amended and Restated 1998 Equity Incentive Plan, Tenth Amended and Restated 2004 Stock Option and Incentive Plan, and Fourth Amended and Restated 2010 Employee Stock Purchase Plan.
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(2)
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As of December 31, 2019, there were 250,410 shares available for future grant under the Eleventh Amended and Restated 2004 Stock Option and Incentive Plan and 10,946 shares available under the Fourth Amended and Restated 2010 Employee Stock Purchase Plan.
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(3)
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Includes information related to our Amended and Restated 2009 Non-Qualified Inducement Stock Plan, which is designed to provide equity grants to new employees. Pursuant to this plan, we were authorized to issue Non-Qualified Stock Options, Restricted Stock Awards and Unrestricted Stock Awards.
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•
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Point-of-care neuropathy diagnostic tests
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•
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Wearable neurostimulation devices
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|
Years Ended December 31,
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|||||||||
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2019
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|
2018
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Change
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|
% Change
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|||||||
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(in thousands)
|
|
|
|||||||||||
Revenues
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$
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9,272.5
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|
$
|
16,090.1
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|
|
$
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(6,817.6
|
)
|
|
(42.4
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)%
|
|
Years Ended December 31,
|
|
|
|
|
|||||||||
|
2019
|
|
2018
|
|
Change
|
|
% Change
|
|||||||
|
(in thousands)
|
|
|
|||||||||||
Cost of revenues
|
$
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7,026.9
|
|
|
$
|
8,707.1
|
|
|
$
|
(1,680.2
|
)
|
|
(19.3
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)%
|
Gross profit
|
$
|
2,245.6
|
|
|
$
|
7,383.1
|
|
|
$
|
(5,137.5
|
)
|
|
(69.6
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)%
|
|
Years Ended December 31,
|
|
|
|
|
|||||||||
|
2019
|
|
2018
|
|
Change
|
|
% Change
|
|||||||
|
(in thousands)
|
|
|
|||||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
$
|
3,102.0
|
|
|
$
|
5,134.6
|
|
|
$
|
(2,032.6
|
)
|
|
(39.6
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)%
|
Sales and marketing
|
4,755.2
|
|
|
9,698.8
|
|
|
(4,943.6
|
)
|
|
(51.0
|
)%
|
|||
General and administrative
|
5,923.2
|
|
|
4,841.2
|
|
|
1,082.0
|
|
|
22.3
|
%
|
|||
Total operating expenses
|
$
|
13,780.4
|
|
|
$
|
19,674.6
|
|
|
$
|
(5,894.2
|
)
|
|
(30.0
|
)%
|
|
Years Ended December 31,
|
|
|
|||||||||||
|
2019
|
|
2018
|
|
Change
|
|
% Change
|
|||||||
|
(in thousands)
|
|
|
|||||||||||
|
|
|
|
|
|
|
|
|||||||
Collaboration income
|
$
|
7,716.7
|
|
|
$
|
12,255.7
|
|
|
$
|
(4,539.0
|
)
|
|
(37.0
|
)%
|
|
Years Ended December 31,
|
|
|
|||||||||||
|
2019
|
|
2018
|
|
Change
|
|
% Change
|
|||||||
|
(in thousands)
|
|
|
|||||||||||
|
|
|
|
|
|
|
|
|||||||
Other income
|
$
|
45.0
|
|
|
$
|
59.5
|
|
|
$
|
(14.5
|
)
|
|
(24.4
|
)%
|
|
December 31,
2019
|
|
December 31,
2018
|
|
Change
|
|
% Change
|
|||||||
|
(in thousands)
|
|
|
|||||||||||
Cash and cash equivalents
|
$
|
3,126.2
|
|
|
$
|
6,780.4
|
|
|
$
|
(3,654.2
|
)
|
|
(53.9
|
)%
|
|
Years Ended December 31,
|
||||
|
2019
|
|
2018
|
||
Days sales outstanding (days)
|
26.8
|
|
|
39.0
|
|
Inventory turnover rate (times per year)
|
3.5
|
|
|
3.5
|
|
|
Years Ended December 31,
|
||||
|
2019
|
|
2018
|
||
|
(in thousands)
|
||||
Net cash used in operating activities (excluding cash provided by collaboration income)
|
(11,338.0
|
)
|
|
(11,350.5
|
)
|
Net cash provided by collaboration income
|
7,716.7
|
|
|
14,212.2
|
|
Net cash provided by (used in) operating activities
|
(3,621.3
|
)
|
|
2,861.7
|
|
Net cash used in investing activities
|
(48.1
|
)
|
|
(143.6
|
)
|
Net cash provided by financing activities
|
15.1
|
|
|
18.6
|
|
Exhibit Number
|
|
Exhibit Description
|
|
Filed with this Report
|
|
Incorporated by
Reference herein
from Form or
Schedule
|
|
Filing Date
|
|
SEC File/
Registration
Number
|
|
Third Amended and Restated Certificate of Incorporation of NeuroMetrix, Inc. dated July 27, 2004
|
|
|
|
S-8
(Exhibit 4.1)
|
|
8/9/2004
|
|
333-118059
|
|
|
Certificate of Designations for Series A Junior Cumulative Preferred Stock, par value $0.001 per share, dated March 7, 2007
|
|
|
|
8-A12(b)
(Exhibit 3.1)
|
|
3/8/2007
|
|
001-33351
|
|
|
Certificate of Amendment to Restated Certificate of Incorporation of NeuroMetrix, Inc. dated September 1, 2011
|
|
|
|
8-K
(Exhibit 3.1)
|
|
9/1/2011
|
|
001-33351
|
|
|
Certificate of Amendment to Restated Certificate of Incorporation of NeuroMetrix, Inc. dated February 15, 2013
|
|
|
|
8-K
(Exhibit 3.1)
|
|
2/15/2013
|
|
001-33351
|
|
3/1/2005
|
|
Certificate of Amendment to Restated Certificate of Incorporation of NeuroMetrix, Inc. dated December 1, 2015
|
|
|
|
8-K
(Exhibit 3.1)
|
|
12/1/2015
|
|
001-33351
|
3.1.6
|
|
Certificate of Amendment ti Restated Certificate of Incorporation of NeuroMetrix, Inc. dated May 11, 2017
|
|
|
|
8-K
(Exhibit 3.1)
|
|
5/12/2017
|
|
001-33351
|
3.1.7
|
|
Certificate of Amendment to Restated Certificate of Incorporation of NeuroMetrix, Inc. dated November 18, 2019
|
|
|
|
8-K
(Exhibit 3.1)
|
|
11/18/2019
|
|
001-33351
|
3.1.8
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series A-1 Convertible Preferred Stock, par value $0.001 per share, dated June 5, 2013
|
|
|
|
8-K
(Exhibit 3.1)
|
|
6/6/2013
|
|
001-33351
|
3.1.9
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series A-2 Convertible Preferred Stock, par value $0.001 per share, dated June 5, 2013
|
|
|
|
8-K
(Exhibit 3.2)
|
|
6/6/2013
|
|
001-33351
|
3.1.10
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series A-3 Convertible Preferred Stock, par value $0.001 per share, dated June 24, 2014
|
|
|
|
8-K
(Exhibit 3.1)
|
|
6/25/2014
|
|
001-33351
|
Exhibit Number
|
|
Exhibit Description
|
|
Filed with this Report
|
|
Incorporated by
Reference herein
from Form or
Schedule
|
|
Filing Date
|
|
SEC File/
Registration
Number
|
3.1.11
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series A-4 Convertible Preferred Stock, par value $0.001 per share, dated June 24, 2014
|
|
|
|
8-K
(Exhibit 3.2)
|
|
6/25/2014
|
|
001-33351
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock, par value $0.001 per share, dated May 26, 2015
|
|
|
|
8-K
(Exhibit 3.1)
|
|
5/29/2015
|
|
001-33351
|
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock, par value $0.001 per share, dated December 30, 2015
|
|
|
|
8-K
(Exhibit 3.1)
|
|
12/30/2015
|
|
001-33351
|
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred Stock, par value $0.001 per share, dated June 3, 2016
|
|
|
|
8-K
(Exhibit 3.1)
|
|
6/3/2016
|
|
001-33351
|
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Preferred Stock, par value $0.001 per share, dated December 28, 2016
|
|
|
|
8-K
(Exhibit 3.1)
|
|
12/29/2016
|
|
001-33351
|
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock, par value $0.001 per share, dated July 10, 2017
|
|
|
|
8-K
(Exhibit 3.1)
|
|
7/11/2017
|
|
001-33351
|
|
|
Second Amended and Restated Bylaws of NeuroMetrix, Inc.
|
|
|
|
S-8
(Exhibit 4.2)
|
|
8/9/2004
|
|
333-118059
|
|
|
Amendment No. 1 to Second Amended and Restated Bylaws of NeuroMetrix, Inc.
|
|
|
|
8-K
(Exhibit 3.1)
|
|
9/17/2007
|
|
001-33351
|
|
|
Description of Securities of the Registrant
|
|
X
|
|
|
|
|
|
|
|
4.2
|
|
Specimen Certificate for Shares of Common Stock
|
|
|
|
S-1/A
(Exhibit 4.1)
|
|
7/19/2004
|
|
333-115440
|
4.3.1
|
|
Shareholder Rights Agreement, dated as of March 7, 2007, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
|
|
8-A12(b)
(Exhibit 4.1)
|
|
3/8/2007
|
|
001-33351
|
4.3.2
|
|
Amendment to Shareholder Rights Agreement, dated September 8, 2009, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
|
|
8-K
(Exhibit 4.1)
|
|
9/14/2009
|
|
001-33351
|
4.3.3
|
|
Amendment No. 2 to Shareholder Rights Agreement, dated June 5, 2013, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
|
|
8-K
(Exhibit 4.2)
|
|
6/6/2013
|
|
001-33351
|
4.3.4
|
|
Amendment No. 3 to Shareholder Rights Agreement, dated June 25, 2014, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
|
|
8-K
(Exhibit 4.2)
|
|
6/25/2014
|
|
001-33351
|
Exhibit Number
|
|
Exhibit Description
|
|
Filed with this Report
|
|
Incorporated by
Reference herein
from Form or
Schedule
|
|
Filing Date
|
|
SEC File/
Registration
Number
|
4.3.5
|
|
Amendment No. 4 to Shareholder Rights Agreement, dated May 28, 2015, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
|
|
10-Q
(Exhibit 4.1)
|
|
7/23/2015
|
|
001-33351
|
4.3.6
|
|
Amendment No. 5 to Shareholder Rights Agreement, dated December 29, 2015, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
|
|
8-K
(Exhibit 4.3)
|
|
12/30/2015
|
|
001-33351
|
4.3.7
|
|
Amendment No. 6 to Shareholder Rights Agreement, dated June 3, 2016, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
|
|
8-K
(Exhibit 4.2)
|
|
6/3/2016
|
|
001-33351
|
4.3.8
|
|
Amendment No. 7 to Shareholder Rights Agreement, dated December 28, 2016, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
|
|
8-K
(Exhibit 4.2)
|
|
12/29/2016
|
|
001-33351
|
4.3.9
|
|
Amendment No. 8 to Shareholder Rights Agreement, dated February 8, 2017, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
|
|
10-K
(Exhibit 4.2.9)
|
|
2/8/2017
|
|
001-33351
|
4.3.10
|
|
Amendment No. 9 to Shareholder Rights Agreement, dated July 10, 2017, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
|
|
8-K
(Exhibit 4.2)
|
|
7/11/2017
|
|
001-33351
|
4.3.11
|
|
Amendment No. 10 to Shareholder Rights Agreement, dated February 5, 2018, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
|
|
10-K
(Exhibit 4.2.11) |
|
2/8/2018
|
|
001-33351
|
4.3.12
|
|
Amendment No. 11 to Shareholder Rights Agreement, dated January 21, 2019, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
|
|
10-K
(Exhibit 4.2.11) |
|
1/24/2019
|
|
001-33351
|
|
Amendment No. 12 to Shareholder Rights Agreement, dated January 27, 2020, between NeuroMetrix, Inc. and American Stock Transfer & Trust Company, as Rights Agent
|
|
X
|
|
|
|
|
|
|
|
4.4.1
|
|
Form of Unit Warrant to purchase Common Stock (February 2012)
|
|
|
|
S-1/A
(Exhibit 4.5)
|
|
1/31/2012
|
|
333-178165
|
4.4.2
|
|
Form of Placement Agent Warrant (February 2012)
|
|
|
|
S-1/A
(Exhibit 4.6)
|
|
1/31/2012
|
|
333-178165
|
4.5
|
|
Form of Common Stock Purchase Warrant (June 2013)
|
|
|
|
8-K/A
(Exhibit 4.1)
|
|
6/7/2013
|
|
001-33351
|
4.6
|
|
Form of Common Stock Purchase Warrant (June 2014)
|
|
|
|
8-K
(Exhibit 4.1)
|
|
6/25/2014
|
|
001-33351
|
4.7.1
|
|
Form of Warrant (2015) issued as part of a Unit on May 29, 2015
|
|
|
|
S-1/A
(Exhibit 4.3)
|
|
5/4/2015
|
|
333-188133
|
4.7.2
|
|
Form of Underwriter’s Warrant (2015) issued on May 29, 2015
|
|
|
|
S-1/A
(Exhibit 4.5)
|
|
4/13/2015
|
|
333-188133
|
4.8
|
|
Form of Series A Common Stock Purchase Warrant (December 2015)
|
|
|
|
8-K
(Exhibit 4.1)
|
|
12/30/2015
|
|
001-33351
|
Exhibit Number
|
|
Exhibit Description
|
|
Filed with this Report
|
|
Incorporated by
Reference herein
from Form or
Schedule
|
|
Filing Date
|
|
SEC File/
Registration
Number
|
4.9
|
|
Form of Series B Common Stock Purchase Warrant (December 2015)
|
|
|
|
8-K
(Exhibit 4.2)
|
|
12/30/2015
|
|
001-33351
|
4.10
|
|
Form of Common Stock Purchase Warrant (June 2016)
|
|
|
|
8-K
(Exhibit 4.1)
|
|
6/3/2016
|
|
001-33351
|
4.11
|
|
Form of Common Stock Purchase Warrant (December 2016)
|
|
|
|
8-K
(Exhibit 4.1)
|
|
12/29/2016
|
|
001-33351
|
Lease Agreements
|
|
|
|
|
|
|
|
|
||
|
Lease Agreement, dated August 27, 2014, between Cummings Properties, LLC and NeuroMetrix, Inc.
|
|
|
|
10-Q
(Exhibit 10.1)
|
|
10/28/2014
|
|
011-33351
|
|
|
Lease Agreement, dated September 10, 2014, between, Boston Properties, Inc. and NeuroMetrix, Inc.
|
|
|
|
10-Q
(Exhibit 10.2)
|
|
10/28/2014
|
|
011-33351
|
|
10.1.3
|
|
Lease Extension #1, dated June 14, 2018, between Cummings Properties, LLC and NeuroMetrix, Inc.
|
|
X
|
|
|
|
|
|
|
Credit Facilities, Loan and Equity Agreements
|
|
|
|
|
|
|
|
|
||
|
Loan and Security Agreement between NeuroMetrix, Inc. and Comerica Bank, dated March 5, 2010
|
|
|
|
10-Q
(Exhibit 10.1)
|
|
5/14/2010
|
|
001-33351
|
|
|
First Modification to Loan and Security Agreement between NeuroMetrix, Inc. and Comerica Bank, dated March 1, 2011
|
|
|
|
8-K
(Exhibit 10.1)
|
|
3/3/2011
|
|
001-33351
|
|
|
Fifth Modification to Loan and Security Agreement between NeuroMetrix, Inc. and Comerica Bank, dated January 31, 2014
|
|
|
|
10-Q
(Exhibit 10.1)
|
|
4/24/2014
|
|
001-33351
|
|
|
Sixth Modification to Loan and Security Agreement with Comerica Bank, dated January 23, 2015
|
|
|
|
10-Q
(Exhibit 10.1)
|
|
4/24/2015
|
|
001-33351
|
|
|
Seventh Modification to Loan and Security Agreement with Comerica Bank, dated January 14, 2016
|
|
|
|
10-K
(Exhibit 10.2.5)
|
|
2/12/2016
|
|
001-33351
|
|
|
Eighth Modification to Loan and Security Agreement with Comerica Bank, dated December 27, 2016
|
|
|
|
10-K
(Exhibit 10.2.6)
|
|
2/9/2017
|
|
001-33351
|
|
|
Ninth Modification to Loan and Security Agreement with Comerica Bank, dated January 17, 2018
|
|
|
|
10-K
(Exhibit 10.2.7) |
|
2/8/2018
|
|
001-33351
|
|
|
Tenth Modification to Loan and Security Agreement with Comerica Bank, dated January 14, 2019
|
|
|
|
10-K
(Exhibit 10.2.8) |
|
1/24/2019
|
|
001-33351
|
|
|
Eleventh Modification to Loan and Security Agreement with Comerica Bank, dated March 25, 2019
|
|
X
|
|
|
|
|
|
|
|
|
Twelfth Modification to Loan and Security Agreement with Comerica Bank, dated June 21, 2019
|
|
X
|
|
|
|
|
|
|
|
|
Thirteenth Modification to Loan and Security Agreement with Comerica Bank, dated September 30, 2019
|
|
X
|
|
|
|
|
|
|
Exhibit Number
|
|
Exhibit Description
|
|
Filed with this Report
|
|
Incorporated by
Reference herein
from Form or
Schedule
|
|
Filing Date
|
|
SEC File/
Registration
Number
|
|
Fourteenth Modification to Loan and Security Agreement with Comerica Bank, dated November 25, 2019
|
|
X
|
|
|
|
|
|
|
|
|
Fifteenth Modification to Loan and Security Agreement with Comerica Bank, dated January 23, 2020
|
|
X
|
|
|
|
|
|
|
|
|
Repurchase and Forfeiture Agreement by and between NeuroMetrix, Inc. and the parties named therein
|
|
|
|
10-Q
(Exhibit 10.1)
|
|
7/23/2015
|
|
001-33351
|
|
|
Securities Purchase Agreement by and between NeuroMetrix, Inc. and the purchasers named therein, dated December 29, 2015
|
|
|
|
8-K
(Exhibit 10.1)
|
|
12/30/2015
|
|
001-33351
|
|
|
Registration Rights Agreement by and between NeuroMetrix, Inc. and the purchasers named therein, dated December 29, 2015
|
|
|
|
8-K
(Exhibit 10.2)
|
|
12/30/2015
|
|
001-33351
|
|
|
Securities Purchase Agreement by and between NeuroMetrix, Inc. and the purchasers named therein, dated June 2, 2016
|
|
|
|
8-K
(Exhibit 10.1)
|
|
6/3/2016
|
|
001-33351
|
|
|
Registration Rights Agreement by and between NeuroMetrix, Inc. and the purchasers named therein, dated June 2, 2016
|
|
|
|
8-K
(Exhibit 10.2)
|
|
6/3/2016
|
|
001-33351
|
|
|
Securities Purchase Agreement by and between NeuroMetrix, Inc. and the purchasers named therein, dated December 28, 2016
|
|
|
|
8-K
(Exhibit 10.1)
|
|
12/29/2016
|
|
001-33351
|
|
|
Registration Rights Agreement by and between NeuroMetrix, Inc. and the purchasers named therein, dated December 28, 2016
|
|
|
|
8-K
(Exhibit 10.2)
|
|
12/29/2016
|
|
001-33351
|
|
Equity Compensation Plans
|
|
|
|
|
|
|
|
|
||
10.7+
|
|
Amended and Restated 1996 Stock Option/Restricted Stock Plan
|
|
|
|
S-1/A
(Exhibit 10.2)
|
|
6/22/2004
|
|
333-115440
|
10.8.1+
|
|
Amended and Restated 1998 Equity Incentive Plan
|
|
|
|
S-1/A
(Exhibit 10.3)
|
|
6/22/2004
|
|
333-115440
|
10.8.2+
|
|
Second Amendment to Amended and Restated 1998 Equity Incentive Plan
|
|
|
|
S-1
(Exhibit 10.18)
|
|
6/22/2004
|
|
333-115440
|
10.9.1+
|
|
Eleventh Amended and Restated 2004 Stock Option and Incentive Plan
|
|
|
|
14A
(Appendix C)
|
|
1/18/2019
|
|
001-33351
|
10.9.2+
|
|
Form of Restricted Stock Agreement
|
|
|
|
10-Q
(Exhibit 10.4)
|
|
5/14/2010
|
|
001-33351
|
10.9.3+
|
|
Form of Incentive Stock Option Agreement
|
|
|
|
10-Q
(Exhibit 10.1)
|
|
11/15/2004
|
|
000-50856
|
10.9.4+
|
|
Form of Non-Qualified Stock Option Agreement For Company Employees
|
|
|
|
10-Q
(Exhibit 10.2)
|
|
11/15/2004
|
|
000-50856
|
10.9.5+
|
|
Form of Non-Qualified Stock Option Agreement For Non-Employee Directors
|
|
|
|
10-Q
(Exhibit 10.3)
|
|
11/15/2004
|
|
000-50856
|
10.10+
|
|
2009 Non-Qualified Inducement Stock Plan
|
|
|
|
S-8
(Exhibit 99.1)
|
|
6/3/2009
|
|
333-159712
|
Exhibit Number
|
|
Exhibit Description
|
|
Filed with this Report
|
|
Incorporated by
Reference herein
from Form or
Schedule
|
|
Filing Date
|
|
SEC File/
Registration
Number
|
10.11.1+
|
|
Fourth Amended and Restated 2010 Employee Stock Purchase Plan
|
|
|
|
14A
(Appendix B)
|
|
3/9/2018
|
|
001-33351
|
Agreements with Executive Officers and Directors
|
|
|
|
|
|
|
|
|
||
10.12+
|
|
Form of Indemnification Agreement between NeuroMetrix, Inc. and each of its directors
|
|
|
|
S-1/A
(Exhibit 10.8)
|
|
6/22/2004
|
|
333-115440
|
10.13.1+
|
|
Employment Agreement, dated June 21, 2004, by and between NeuroMetrix, Inc. and Shai N. Gozani, M.D., Ph.D.
|
|
|
|
S-1/A
(Exhibit 10.9)
|
|
6/22/2004
|
|
333-115440
|
10.13.2+
|
|
First Amendment to Employment Agreement dated December 31, 2008, by and between NeuroMetrix, Inc. and Shai N. Gozani, M.D., Ph.D.
|
|
|
|
10-K
(Exhibit 10.11)
|
|
3/20/2009
|
|
001-33351
|
10.13.3+
|
|
Indemnification Agreement dated June 21, 2004, by and between Shai N. Gozani, M.D., Ph.D., and NeuroMetrix, Inc.
|
|
|
|
S-1/A
(Exhibit 10.20)
|
|
6/22/2004
|
|
333-115440
|
|
Employment Agreement dates December 31, 2019, by and between NeuroMetrix, Inc. and Shai N. Gozani, M.D., Ph.D., and NeuroMetrix
|
|
X
|
|
|
|
|
|
|
|
10.14.1+
|
|
Indemnification Agreement, dated September 10, 2009, by and between NeuroMetrix, Inc. and Thomas T. Higgins
|
|
|
|
8-K
(Exhibit 10.2)
|
|
9/15/2009
|
|
001-33351
|
10.14.2+
|
|
Employment Agreement, dated October 27, 2014 by and between NeuroMetrix, Inc. and Thomas T. Higgins
|
|
|
|
10-Q
(Exhibit 10.4)
|
|
10/28/2014
|
|
001-33351
|
|
Employment Agreement, dates December 31, 2019 by and between NeuroMetrix, Inc. and Thomas T. Higgins
|
|
X
|
|
|
|
|
|
|
|
10.15.1+
|
|
Letter Agreement, dated August 14, 2014, between NeuroMetrix, Inc. and Francis X. McGillin
|
|
|
|
10-Q
(Exhibit 10.5)
|
|
10/28/2014
|
|
001-33351
|
10.16+
|
|
Amended and Restated Management Retention and Incentive Plan, as modified, dated February 3, 2017
|
|
|
|
10-K
(Exhibit 10.17)
|
|
2/9/2017
|
|
001-33351
|
Exhibit Number
|
|
Exhibit Description
|
|
Filed with this Report
|
|
Incorporated by
Reference herein
from Form or
Schedule
|
|
Filing Date
|
|
SEC File/
Registration
Number
|
Agreements with Respect to Collaborations, Licenses, Research and Development
|
|
|
|
|
||||||
|
Amended and Restated Management Retention and Incentive Plan, as modified, dated January 20, 2020
|
|
X
|
|
|
|
|
|
|
|
10.17†
|
|
Manufacturing and Supply Agreement, dated as of August 2, 2006, by and between Parlex Polymer Flexible Circuits, Inc. and NeuroMetrix, Inc.
|
|
|
|
8-K
(Exhibit 99.1)
|
|
8/2/2006
|
|
000-50856
|
10.18†
|
|
Asset Purchase Agreement, dated as of January 12, 2018, by and between Novartis Consumer Health S.A. and NeuroMetrix, Inc.
|
|
|
|
10-K
(Exhibit 10.19) |
|
2/8/2018
|
|
001-33351
|
10.19†
|
|
Development and Services Agreement, dated as of January 12, 2018, by and between Novartis Consumer Health S.A. and NeuroMetrix, Inc.
|
|
|
|
10-K
(Exhibit 10.20) |
|
2/8/2018
|
|
001-33351
|
10.20†
|
|
Contribution Agreement, dated as of December 22, 2017, by and between Quell Intellectual Property Corp., LLC and NeuroMetrix, Inc.
|
|
|
|
10-K
(Exhibit 10.21) |
|
2/8/2018
|
|
001-33351
|
10.21†
|
|
Amended and Restated Limited Liability Company Agreement of Quell Intellectual Property Corp., LLC, dated as of January 12, 2018, by and between Novartis Consumer Health S.A. and NeuroMetrix, Inc.
|
|
|
|
10-K
(Exhibit 10.22) |
|
2/8/2018
|
|
001-33351
|
10.22
|
|
NeuroMetrix License Agreement, dated as of December 21, 2017, by and between Quell Intellectual Property Corp., LLC and NeuroMetrix, Inc.
|
|
|
|
10-K
(Exhibit 10.23) |
|
2/8/2018
|
|
001-33351
|
10.23
|
|
GSK License Agreement, dated as of December 21, 2017, by and between Quell Intellectual Property Corp., LLC and NeuroMetrix, Inc.
|
|
|
|
10-K
(Exhibit 10.24) |
|
2/8/2018
|
|
001-33351
|
10.24
|
|
Assignment Agreement, dated as of January 12, 2018, by and between Novartis Consumer Health S.A. and NeuroMetrix, Inc.
|
|
|
|
10-K
(Exhibit 10.25) |
|
2/8/2018
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001-33351
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10.25*
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Amendment No.1 to Development and Services Agreement, dated as of December 6, 2018, by and between GSK Consumer Health S.A. and NeuroMetrix, Inc.
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10-K
(Exhibit 10.26) |
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1/24/2019
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001-33351
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Consent of Moody, Famiglietti & Andronico, LLP, an independent registered public accounting firm.
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X
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Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.
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X
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Certification of Principal Accounting and Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.
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X
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Exhibit Number
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Exhibit Description
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Filed with this Report
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Incorporated by
Reference herein
from Form or
Schedule
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Filing Date
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SEC File/
Registration
Number
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Certification of the Principal Executive Officer and the Principal Accounting and Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002.
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X
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101
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The following materials from NeuroMetrix, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2019, formatted in XBRL (Extensible Business Reporting Language): (i) Balance Sheets as of December 31, 2019 and 2018, (ii) Statements of Operations for the years ended December 31, 2019 and 2018, (iii) Statements of Changes in Stockholders’ Equity for the years ended December 31, 2018 and 2017, (iv) Statements of Cash Flows for the years ended December 31, 2018 and 2017, and (v) Notes to Financial Statements.
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X
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+
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Indicates management contract or any compensatory plan, contract or arrangement.
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†
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Confidential treatment has been granted with respect to certain portions of this Exhibit, which portions have been omitted and filed separately with the Securities and Exchange Commission as part of an application for confidential treatment pursuant to the Securities Exchange Act of 1934, as amended.
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*
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Confidential treatment has been requested with respect to certain portions of this Exhibit, which portions have been omitted and filed separately with the Securities and Exchange Commission as part of an application for confidential treatment pursuant to the Securities Exchange Act of 1934, as amended.
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By:
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/s/ SHAI N. GOZANI, M.D., PH.D.
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Shai N. Gozani, M.D., Ph.D.
Chairman, President and Chief Executive Officer
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Name
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Title
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/s/ SHAI N. GOZANI, M.D., PH.D.
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Chairman, President and Chief Executive Officer
(Principal Executive Officer)
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Shai N. Gozani, M.D., Ph.D.
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/s/ THOMAS T. HIGGINS
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Senior Vice President, Chief Financial Officer and Treasurer
(Principal Financial Officer and Principal Accounting Officer)
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Thomas T. Higgins
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/s/ DAVID E. GOODMAN, M.D.
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Director
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David E. Goodman, M.D.
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/s/ NANCY E. KATZ
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Director
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Nancy E. Katz
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/s/ TIMOTHY R. SURGENOR
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Director
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Timothy R. Surgenor
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/s/ DAVID VAN AVERMAETE
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Director
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David Van Avermaete
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December 31,
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||||||
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2019
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2018
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Assets
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Current assets:
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Cash and cash equivalents
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$
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3,126,206
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$
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6,780,429
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Accounts receivable, net of allowances of $70,000 and $25,000 at December 31, 2019 and 2018, respectively
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298,967
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1,082,957
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Inventories
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1,163,714
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2,861,864
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Collaboration receivable
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189,008
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—
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Prepaid expenses and other current assets
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652,919
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860,915
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Total current assets
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5,430,814
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11,586,165
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Fixed assets, net
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273,448
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407,339
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Right to use asset
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1,159,774
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1,968,062
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Other long-term assets
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29,650
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30,314
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Total assets
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$
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6,893,686
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$
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13,991,880
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Liabilities and Stockholders’ Equity
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Current liabilities:
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Accounts payable
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$
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725,658
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$
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1,298,084
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Accrued expenses and compensation
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1,443,574
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1,659,173
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Accrued product returns
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689,000
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1,101,658
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Lease obligation, current
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588,546
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577,460
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Deferred collaboration income
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—
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1,956,522
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Total current liabilities
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3,446,778
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6,592,897
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Lease obligation, net of current portion
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916,674
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1,301,172
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Total liabilities
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4,363,452
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7,894,069
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Commitments and contingencies (Note 8)
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Stockholders’ equity
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Preferred stock
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—
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—
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Convertible preferred stock
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1
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18
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Common stock, $0.0001 par value; 25,000,000 and 100,000,000 authorized at December 31, 2019 and 2018; 1,400,674 and 738,029 shares issued and outstanding at December 31, 2019 and 2018, respectively
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140
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74
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Additional paid-in capital
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197,319,698
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197,114,310
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Accumulated deficit
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(194,789,605
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)
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(191,016,591
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)
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Total stockholders’ equity
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2,530,234
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6,097,811
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Total liabilities and stockholders’ equity
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$
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6,893,686
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$
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13,991,880
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Years Ended December 31,
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2019
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2018
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Revenues
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$
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9,272,522
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$
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16,090,138
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Cost of revenues
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7,026,899
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8,707,082
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Gross profit
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2,245,623
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7,383,056
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Operating expenses:
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Research and development
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3,101,976
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5,134,592
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Sales and marketing
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4,755,168
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9,698,753
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General and administrative
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5,923,190
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4,841,278
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Total operating expenses
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13,780,334
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19,674,623
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Loss from operations
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(11,534,711
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(12,291,567
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Other income:
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Collaboration income
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7,716,667
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12,255,704
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Other income
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45,030
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59,468
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Total other income
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7,761,697
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12,315,172
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Net income (loss) applicable to common stockholders:
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(3,773,014
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23,605
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Net income (loss) per common share applicable to common stockholders:
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Basic
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$
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(3.90
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$
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0.03
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Diluted
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$
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(3.90
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$
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0.02
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Series B – F
Convertible Preferred Stock
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Common
Stock
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Additional
Paid-In
Capital
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Accumulated
Deficit
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Total
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||||||||||||||||
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Number of
Shares
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Amount
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Number of
Shares
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Amount
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Balance at December 31, 2017
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29,479.98
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$
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30
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270,590
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$
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27
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$
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196,355,386
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$
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(191,338,054
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)
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$
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5,017,389
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Stock-based compensation expense
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—
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$
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—
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—
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$
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—
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$
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446,077
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$
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—
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$
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446,077
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Issuance of common stock upon conversion of preferred stock
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(11,966.35
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)
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$
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(12
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443,680
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$
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44
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$
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(32
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$
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—
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$
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—
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Common stock issued to settle employee incentive compensation obligations
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—
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$
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—
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21479
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$
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2
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$
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294,262
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$
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—
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$
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294,264
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Issuance of common stock under employee stock purchase plan
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—
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$
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—
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2,280
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$
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1
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$
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18,617
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$
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—
|
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$
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18,618
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Adoption of ASC606
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$
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—
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