x
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
For the fiscal year ended December 31, 2015
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
For the transition period from to
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Delaware
|
|
04-3523891
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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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|
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600 Technology Park Drive, Suite 200
Billerica, Massachusetts
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01821
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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 Each Exchange on Which Registered
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Common Stock, $0.001 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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Large accelerated filer
x
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|
Accelerated filer
o
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|
Non-accelerated filer
o
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Smaller reporting company
o
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(Do not check if a smaller reporting company)
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Title of Class
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|
Shares Outstanding
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Common Stock, $0.001 Par Value Per Share
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|
57,015,489
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Preferred Stock Purchase Rights
|
|
—
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•
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Type 1 diabetes is characterized by the body’s nearly complete inability to produce insulin. It is frequently diagnosed during childhood or adolescence. Individuals with Type 1 diabetes require daily insulin therapy, typically administered via injections or continuous infusion through pump therapy, to survive.
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Type 2 diabetes, the more common form of diabetes, is characterized by the body’s inability to either properly utilize insulin or produce enough insulin. Historically, Type 2 diabetes has occurred in later adulthood, but its incidence is increasing among the younger population, due primarily to increasing childhood obesity. Initially, many people with Type 2 diabetes attempt to manage their diabetes with improvements in diet, exercise and/or oral medications. As their diabetes advances, some patients progress to multiple drug therapy, which often includes insulin therapy. Guidelines, including those published by the American Diabetes Association in 2014, suggest more aggressive treatment for people with Type 2 diabetes, including the early adoption of insulin therapy and more frequent testing. It is now becoming more accepted for insulin therapy to be started earlier in people with Type 2 diabetes, and, in some cases, as part of the initial treatment.
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A small, constant background supply of insulin (called a basal rate) is delivered automatically at a programmed rate, all day and night.
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An extra dose of insulin (called a bolus) can be delivered when a patient needs it to match the carbohydrates in a meal or snacks or to correct high blood glucose.
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The Pod is a small, lightweight, self-adhesive device that the patient fills with insulin and wear directly on the body. The Pod delivers precise, personalized doses of insulin into the body through a small flexible tube (called a cannula), based on instructions that the patient programs into the Pod's wireless companion, the PDM.
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The PDM is a wireless, handheld device that programs the Pod with the patient's personalized insulin-delivery instructions, wirelessly monitors the Pod's operation and includes a FreeStyle
®
blood glucose meter.
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the basic architecture of the OmniPod System, including the pump and the PDM;
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the OmniPod shape memory alloy drive system;
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the OmniPod System cannula insertion system;
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communication features between system components;
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software for controlling the OmniPod System; and
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various novel aspects of the OmniPod System and potential future generations of OmniPod Systems.
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First, build patient awareness about the features and benefits that the OmniPod System provides.
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Second, build physician support by increasing the clinical evidence that clearly demonstrates the benefits that the OmniPod System provides.
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Third, provide payors with the clinical and economic justification of why the OmniPod System is a greater benefit for the patients whom they insure.
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significantly greater name recognition;
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established relations with healthcare professionals, customers and third-party payors;
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larger and more established sales forces and distribution networks;
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greater experience in conducting research and development, manufacturing, clinical trials, marketing and obtaining regulatory approval for products; and
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greater financial and human resources for product development, sales and marketing and patent litigation.
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510(k) Clearance
. To obtain 510(k) clearance for any of our potential future devices (or for certain modifications to devices that have previously received 510(k) clearance), we must submit a pre-market notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device or a pre-amendment device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of a PMA application. The FDA’s 510(k) clearance pathway generally takes from three to twelve months from the date the application is completed, but can take significantly longer. After a medical device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a significant change in its intended use, requires a new 510(k) clearance or, depending on the modification, could require a PMA application. The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. As further described below, as part of an inspection conducted by the FDA in December of 2015, we agreed to submit a 510(k) for modifications previously made to the OmniPod System. In addition, we also agreed to submit a 510(k) associated with the field action described below that we initiated in October 2015.
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PMA.
Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, devices deemed not substantially equivalent to a previously cleared 510(k) device or devices in commercial distribution before May 28, 1976 for which PMAs have not been required, generally require a PMA before they can be commercially distributed. A PMA application must be supported by extensive data, including technical information, pre-clinical and clinical trials, manufacturing and labeling to demonstrate the safety and effectiveness of the device to the FDA’s satisfaction. After a PMA application is complete, the FDA begins an in-depth review of the submitted information, which generally takes between one and three years, but may take significantly longer. During this review period, the FDA may request additional information or clarification of information already provided. Also during the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. In addition, the FDA will conduct a pre-approval inspection of the manufacturing facility to ensure compliance with Quality System Regulations, or QSRs, which impose elaborate design development, testing, control, documentation and other quality assurance procedures in the design and manufacturing process. The FDA may approve a PMA application with post-approval conditions intended to ensure the safety and effectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution and collection of long-term follow-up data from patients in the clinical study that supported approval. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including the loss or withdrawal of the approval. After any pre-market approval, a new pre-market approval application or application supplement may be required in the event of modifications to the device, its labeling, intended use or indication or its manufacturing process. PMA supplements often require submission of the same type of information as a PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA application, and may not require as extensive clinical data or the convening of an advisory panel.
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establishment registration and device listing;
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quality system regulation, or QSR, which requires manufacturers, including third party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
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labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or “off-label” uses, and other requirements related to promotional activities;
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medical device reporting regulations, which require that manufacturers report to the FDA if their 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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corrections and removals reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the Federal Food, Drug and Cosmetic Act that may present a risk to health. In addition, FDA may order a mandatory recall if there is a reasonable probability that the device would cause serious adverse health consequences or death; and
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post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device.
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referral of a person;
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furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid or other governmental programs; or
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purchase, lease, or order of, or the arrangement or recommendation of the purchasing, leasing, or ordering of any item or service reimbursable under Medicare, Medicaid or other governmental programs.
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delays in shipping due to capacity constraints;
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practices of health insurance companies and other third-party payors with respect to reimbursement for our current or future products;
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market acceptance of the OmniPod System;
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our ability to manufacture the OmniPod efficiently;
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timing of regulatory approvals and clearances;
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new product introductions;
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competition; and
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timing of research and development expenditures.
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the failure of the OmniPod System to achieve and maintain wide acceptance among opinion leaders in the diabetes treatment community, insulin-prescribing physicians, third-party payors and people with insulin-dependent diabetes;
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manufacturing problems;
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actual or perceived quality problems;
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changes in reimbursement rates or policies relating to the OmniPod System by third-party payors;
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claims that any portion of the OmniPod System infringes on patent rights or other intellectual property rights owned by other parties;
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adverse regulatory or legal actions relating to the OmniPod System;
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damage, destruction or loss of any of the facilities where our products are manufactured or of the equipment therein;
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conversion rate of patient referrals to actual sales of the OmniPod System;
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write-offs of receivables from our customers;
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attrition rates of customers who cease using the OmniPod System;
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competitive pricing and related factors; and
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results of clinical studies relating to the OmniPod System or our competitors’ products.
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revenue generated by sales of our current products and any other future products that we may develop;
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costs associated with adding further manufacturing capacity;
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costs associated with expanding our sales and marketing efforts in the United States and internationally;
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expenses we incur in manufacturing and selling the OmniPod System;
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costs of developing new products or technologies and enhancements to the OmniPod System;
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the cost of obtaining and maintaining FDA approval or clearance of our current or future products;
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costs associated with any expansion;
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the cost of complying with regulatory requirements;
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costs associated with capital expenditures;
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costs associated with litigation; and
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the number and timing of any acquisitions or other strategic transactions.
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we are not a major customer of many of our suppliers, and these suppliers may therefore give other customers’ needs higher priority than ours;
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we may not be able to obtain an adequate supply in a timely manner or on commercially reasonable terms;
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our suppliers, especially new suppliers, may make errors in manufacturing that could negatively affect the efficacy or safety of the OmniPod System or cause delays in shipment;
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we may have difficulty locating and qualifying alternative suppliers for our sole-source supplies;
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switching components may require product redesign and submission to the FDA of a new 510(k);
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our suppliers manufacture products for a range of customers, and fluctuations in demand for the products these suppliers manufacture for others may affect their ability to deliver products to us in a timely manner;
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the occurrence of a fire, natural disaster or other catastrophe, impacting one or more of our suppliers, may affect their ability to deliver products to us in a timely manner; and
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our suppliers may encounter financial hardships unrelated to our demand, which could inhibit their ability to fulfill our orders and meet our requirements.
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political instability and adverse economic conditions;
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trade protection measures, such as tariff increases, and import and export licensing and control requirements;
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potentially negative consequences from changes in tax laws;
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difficulty in staffing and managing widespread operations;
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difficulties associated with foreign legal systems including increased costs associated with enforcing contractual obligations in foreign jurisdictions;
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changes in foreign currency exchange rates;
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differing protection of intellectual property;
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unexpected changes in regulatory requirements;
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failure to fulfill foreign regulatory requirements on a timely basis or at all to market the OmniPod System or other future 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 laws and regulations, business and clinical practices, and patient preferences in foreign markets;
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difficulties in managing foreign relationships and operations, including any relationships that we establish with foreign partners, distributors or sales or marketing agents; and
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difficulty in collecting accounts receivable and longer collection periods.
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significantly greater name recognition;
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different and more complete reimbursement profiles;
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established relations with healthcare professionals, customers and third-party payors;
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larger and more established distribution networks;
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greater experience in conducting research and development, manufacturing, clinical trials, marketing and obtaining regulatory approval; and
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greater financial and human resources for product development, sales and marketing and patent litigation.
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our identification of drug delivery opportunities appropriate for a modified OmniPod;
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our achievement of satisfactory development and pricing terms with the pharmaceutical companies that sell such drugs;
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our development of appropriate modifications to our OmniPods to address the needs and parameters required for the respective drug-delivery opportunities;
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manufacturing issues relating to the modified OmniPod;
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long lead-times associated with the development, regulatory approvals and ramp up applicable to the use of modified OmniPods for the delivery of such drugs;
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relatively small number of modified OmniPods needed to address each drug-delivery opportunity;
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uncertainties regarding the market acceptance of such drugs and the modified OmniPods as appropriate delivery devices;
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uncertainties relating to the success of the pharmaceutical companies in marketing and selling such drugs as well as the modified OmniPods as the appropriate delivery devices;
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intense competition in the drug-delivery industry, including from competitors which have substantially greater resources than we do;
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maintaining appropriate gross margins for non-insulin drug delivery products; and
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regulatory requirements and reimbursement rates associated with such drugs.
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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; 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;
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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 or superior 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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untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
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customer notification, or orders for repair, replacement or refunds;
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voluntary or mandatory recall or seizure of our current or future products;
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administrative detention by the FDA of medical devices believed to be adulterated or misbranded;
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imposing operating restrictions, suspension or shutdown of production;
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refusing our requests for 510(k) clearance or pre-market approval of new products, new intended uses or modifications to the OmniPod System;
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rescinding 510(k) clearance or suspending or withdrawing pre-market approvals that have already been granted; and
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criminal prosecution.
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the inability to complete the acquisition or investment;
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disruption of our ongoing businesses and diversion of management attention;
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difficulties in integrating the acquired entities, products or technologies;
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risks associated with acquiring intellectual property;
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difficulties in operating the acquired business profitably;
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the inability to achieve anticipated synergies, cost savings or growth;
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potential loss of key employees, particularly those of the acquired business;
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difficulties in transitioning and maintaining key customer, distributor and supplier relationships;
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risks associated with entering markets in which we have no or limited prior experience; and
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unanticipated costs.
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dilutive issuances of equity securities, which may be sold at a discount to market price;
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the use of significant amounts of cash;
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the incurrence of debt;
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the assumption of significant liabilities;
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increased operating costs or reduced earnings;
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financing obtained on unfavorable terms;
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large one-time expenses; and
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the creation of certain intangible assets, including goodwill, the write-down of which in future periods may result in significant charges to earnings.
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failure to maintain and increase production capacity and reduce per unit production costs;
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changes in the availability of third-party reimbursement in the United States or other countries;
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volume and timing of orders for the OmniPod System;
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•
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developments in administrative proceedings or litigation related to intellectual property rights;
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issuance of patents to us or our competitors;
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the announcement of new products or product enhancements by us or our competitors;
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the announcement of technological or medical innovations in the treatment or diagnosis of diabetes;
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changes in governmental regulations or in the status of our regulatory approvals or applications;
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developments in our industry;
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publication of clinical studies relating to the OmniPod System or a competitor’s product;
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quarterly variations in our or our competitors’ results of operations;
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changes in earnings estimates or recommendations by securities analysts; and
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general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
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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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require advance written notice of stockholder proposals and director nominations.
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High
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Low
|
||||
Fiscal Year 2014
|
|
|
|
||||
First Quarter
|
$
|
50.18
|
|
|
$
|
35.83
|
|
Second Quarter
|
$
|
49.07
|
|
|
$
|
31.69
|
|
Third Quarter
|
$
|
41.11
|
|
|
$
|
32.94
|
|
Fourth Quarter
|
$
|
47.51
|
|
|
$
|
36.75
|
|
Fiscal Year 2015
|
|
|
|
||||
First Quarter
|
$
|
45.18
|
|
|
$
|
29.39
|
|
Second Quarter
|
$
|
31.85
|
|
|
$
|
26.23
|
|
Third Quarter
|
$
|
34.39
|
|
|
$
|
25.64
|
|
Fourth Quarter
|
$
|
39.32
|
|
|
$
|
26.36
|
|
|
2010
|
2011
|
2012
|
2013
|
2014
|
2015
|
||||||||||||
Insulet Corporation
|
$
|
100
|
|
$
|
121
|
|
$
|
137
|
|
$
|
239
|
|
$
|
297
|
|
$
|
244
|
|
NASDAQ Composite
|
100
|
|
101
|
|
117
|
|
166
|
|
189
|
|
200
|
|
||||||
NASDAQ Health Care
|
100
|
|
106
|
|
132
|
|
204
|
|
259
|
|
271
|
|
Plan Category
|
Number of securities to be
issued upon exercise of
outstanding options,
warrants and rights
(a)
|
|
Weighted average
exercise price of
outstanding options,
warrants and rights
(b)
|
|
Number of securities
remaining available for
future issuance under
equity compensation plans
(excluding securities
reflected in column (a))
(c)
|
|
||||
Equity compensation plans approved by security holders
(1)
|
2,929,887
|
|
|
$
|
23.43
|
|
|
6,152,904
|
|
|
Equity compensation plans not approved by security holders
(2)
|
881,277
|
|
|
$
|
28.87
|
|
|
—
|
|
|
Total
(4)
|
3,811,164
|
|
|
$
|
24.69
|
|
|
6,152,904
|
|
(3)
|
|
|
|
|
|
|
Years Ended December 31,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
(3)
|
||||||||||
|
(In thousands, except share and per share data)
|
||||||||||||||||||
Consolidated Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenue
|
$
|
324,225
|
|
|
$
|
288,720
|
|
|
$
|
247,084
|
|
|
$
|
211,369
|
|
|
$
|
152,255
|
|
Cost of revenue
|
176,071
|
|
|
145,432
|
|
|
134,683
|
|
|
119,033
|
|
|
85,543
|
|
|||||
Gross profit
|
148,154
|
|
|
143,288
|
|
|
112,401
|
|
|
92,336
|
|
|
66,712
|
|
|||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development
|
43,208
|
|
|
27,900
|
|
|
21,765
|
|
|
24,359
|
|
|
21,863
|
|
|||||
Sales and marketing
|
88,352
|
|
|
60,844
|
|
|
55,694
|
|
|
52,708
|
|
|
43,233
|
|
|||||
General and administrative
(4)
|
77,359
|
|
|
66,841
|
|
|
64,077
|
|
|
51,240
|
|
|
44,083
|
|
|||||
Total operating expenses
|
208,919
|
|
|
155,585
|
|
|
141,536
|
|
|
128,307
|
|
|
109,179
|
|
|||||
Operating loss
|
(60,765
|
)
|
|
(12,297
|
)
|
|
(29,135
|
)
|
|
(35,971
|
)
|
|
(42,467
|
)
|
|||||
Interest and other expense, net
|
(12,464
|
)
|
|
(39,061
|
)
|
|
(15,739
|
)
|
|
(15,684
|
)
|
|
(14,576
|
)
|
|||||
Income tax benefit (expense)
|
(291
|
)
|
|
(142
|
)
|
|
(100
|
)
|
|
(212
|
)
|
|
11,212
|
|
|||||
Net loss
|
$
|
(73,520
|
)
|
|
$
|
(51,500
|
)
|
|
$
|
(44,974
|
)
|
|
$
|
(51,867
|
)
|
|
$
|
(45,831
|
)
|
Net loss per share basic and diluted
|
$
|
(1.29
|
)
|
|
$
|
(0.93
|
)
|
|
$
|
(0.83
|
)
|
|
$
|
(1.08
|
)
|
|
$
|
(0.98
|
)
|
Weighted-average number of shares used in calculating net loss per share
(1)
|
56,785,646
|
|
|
55,628,542
|
|
|
54,010,887
|
|
|
47,924,324
|
|
|
46,689,880
|
|
|||||
|
|
|
|
|
|
|
|
|
|
||||||||||
|
As of December 31,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
(3)
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash and cash equivalents
|
$
|
122,672
|
|
|
$
|
151,193
|
|
|
$
|
149,727
|
|
|
$
|
57,293
|
|
|
$
|
93,955
|
|
Working capital
|
$
|
125,605
|
|
|
$
|
163,900
|
|
|
$
|
155,824
|
|
|
$
|
61,650
|
|
|
$
|
104,640
|
|
Total assets
|
$
|
275,126
|
|
|
$
|
297,182
|
|
|
$
|
286,541
|
|
|
$
|
196,055
|
|
|
$
|
218,725
|
|
Current portion of long-term debt and capital lease obligations
|
$
|
5,519
|
|
|
$
|
3,380
|
|
|
$
|
2,637
|
|
|
$
|
14,429
|
|
|
$
|
—
|
|
Long-term debt and capital lease obligations
(2)
|
$
|
171,967
|
|
|
$
|
166,283
|
|
|
$
|
117,627
|
|
|
$
|
101,726
|
|
|
$
|
105,943
|
|
Other long-term liabilities
|
$
|
3,952
|
|
|
$
|
2,774
|
|
|
$
|
1,943
|
|
|
$
|
1,867
|
|
|
$
|
2,052
|
|
Total stockholders’ equity
|
$
|
34,051
|
|
|
$
|
83,829
|
|
|
$
|
124,597
|
|
|
$
|
44,176
|
|
|
$
|
82,735
|
|
|
|
|
|
|
(1)
|
In June 2011, we issued 1.2 million shares in connection with the acquisition of Neighborhood Diabetes. In January 2013, we sold 4.7 million shares of common stock to the public. In July 2014, we issued 0.3 million shares of common stock in connection with the repurchase of the 3.75% Senior Convertible Notes. See Footnote 14 to our consolidated financial statements included in this Annual Report on Form 10-K.
|
(2)
|
In June 2008, we sold $85.0 million principal amount of 5.375% Convertible Senior Notes due June 2013 in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. In June 2011, we issued $143.8 million of 3.75% Convertible Notes due June 2016 and repurchased $70 million in principal of the 5.375% Notes. In June 2014, we issued $201.3 million of 2% Convertible Notes due June 2019 and repurchased $114.9 million in 3.75% Notes. In July 2014, the remaining principal balance of the 3.75% Notes were converted and the principal was settled in cash. In 2013 and 2014 we acquired $9.0 million and $1.5 million, respectively, of manufacturing equipment under capital leases. See Footnotes 5 and 6 to our consolidated financial statements included in this Annual Report on Form 10-K.
|
(3)
|
On June 1, 2011, we completed the acquisition of Neighborhood Diabetes, a durable medical equipment distributor, specializing in direct to consumer sales of diabetes supplies for an aggregate purchase price of approximately $37.9 million in cash and $24.4 million in common stock. Neighborhood Diabetes supplied its customers with blood glucose testing supplies, insulin pumps, pump supplies, pharmaceuticals, and other products for the management and treatment of diabetes.
|
(4)
|
Included an impairment charge of $9.1 million related to the impairment of the Neighborhood Diabetes asset group. See Footnote 11 to our consolidated financial statements included in this Annual Report on Form 10-K.
|
•
|
Exceeded expectation within our Drug Delivery business with initial launch of the OmniPod technology for use with Amgen's Neulasta product and expanded the pipeline to six development agreements.
|
•
|
Sold our Neighborhood Diabetes business in February 2016 to focus on faster growing innovative products.
|
•
|
Signed development agreement with Eli Lilly and Company for OmniPod delivery of U200 concentrated insulin, significantly expanding OmniPod's addressable market for Type 1 and Type 2 diabetes.
|
•
|
Signed development agreement with algorithm partner for OmniPod Artificial Pancreas.
|
•
|
Total revenue of $324.2 million
|
◦
|
U.S. OmniPod revenue of $186.8 million
|
◦
|
International OmniPod revenue of $40.3 million
|
◦
|
Drug Delivery revenue of $34.0 million
|
◦
|
Neighborhood Diabetes revenue of $63.1 million.
|
TABLE 1: RESULTS OF OPERATIONS
|
|||||||||||||||||||||||||||||
|
Years Ended December 31,
|
|
Years Ended December 31,
|
||||||||||||||||||||||||||
(In Thousands)
|
2015
|
|
2014
|
|
$ Change
|
|
% Change
|
|
2014
|
|
2013
|
|
$ Change
|
|
% Change
|
||||||||||||||
Revenue
|
$
|
324,225
|
|
|
$
|
288,720
|
|
|
$
|
35,505
|
|
|
12
|
%
|
|
$
|
288,720
|
|
|
$
|
247,084
|
|
|
$
|
41,636
|
|
|
17
|
%
|
Cost of revenue
|
176,071
|
|
|
145,432
|
|
|
30,639
|
|
|
21
|
%
|
|
145,432
|
|
|
134,683
|
|
|
10,749
|
|
|
8
|
%
|
||||||
Gross profit
|
148,154
|
|
|
143,288
|
|
|
4,866
|
|
|
3
|
%
|
|
143,288
|
|
|
112,401
|
|
|
30,887
|
|
|
27
|
%
|
||||||
Gross margin
|
45.7
|
%
|
|
49.6
|
%
|
|
|
|
|
|
49.6
|
%
|
|
45.5
|
%
|
|
|
|
|
||||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Research and development
|
43,208
|
|
|
27,900
|
|
|
15,308
|
|
|
55
|
%
|
|
27,900
|
|
|
21,765
|
|
|
6,135
|
|
|
28
|
%
|
||||||
Sales and marketing
|
88,352
|
|
|
60,844
|
|
|
27,508
|
|
|
45
|
%
|
|
60,844
|
|
|
55,694
|
|
|
5,150
|
|
|
9
|
%
|
||||||
General and administrative
|
77,359
|
|
|
66,841
|
|
|
10,518
|
|
|
16
|
%
|
|
66,841
|
|
|
64,077
|
|
|
2,764
|
|
|
4
|
%
|
||||||
Total operating expenses
|
208,919
|
|
|
155,585
|
|
|
53,334
|
|
|
34
|
%
|
|
155,585
|
|
|
141,536
|
|
|
14,049
|
|
|
10
|
%
|
||||||
Operating loss
|
(60,765
|
)
|
|
(12,297
|
)
|
|
48,468
|
|
|
394
|
%
|
|
(12,297
|
)
|
|
(29,135
|
)
|
|
(16,838
|
)
|
|
(58
|
)%
|
||||||
Interest and other expense, net
|
(12,464
|
)
|
|
(39,061
|
)
|
|
(26,597
|
)
|
|
(68
|
)%
|
|
(39,061
|
)
|
|
(15,739
|
)
|
|
23,322
|
|
|
148
|
%
|
||||||
Income tax expense
|
(291
|
)
|
|
(142
|
)
|
|
149
|
|
|
105
|
%
|
|
(142
|
)
|
|
(100
|
)
|
|
42
|
|
|
42
|
%
|
||||||
Net loss
|
$
|
(73,520
|
)
|
|
$
|
(51,500
|
)
|
|
$
|
22,020
|
|
|
43
|
%
|
|
$
|
(51,500
|
)
|
|
$
|
(44,974
|
)
|
|
$
|
6,526
|
|
|
15
|
%
|
|
|
Years Ended December 31,
|
||||||||||
(In thousands)
|
|
2015
|
|
2014
|
|
2013
|
||||||
Cash (used in) provided by:
|
|
|
|
|
|
|
||||||
Operating activities
|
|
$
|
(12,552
|
)
|
|
$
|
8,920
|
|
|
$
|
3,348
|
|
Investing activities
|
|
(15,323
|
)
|
|
(11,486
|
)
|
|
(7,307
|
)
|
|||
Financing activities
|
|
(371
|
)
|
|
4,032
|
|
|
96,393
|
|
|||
Effect of exchange rate changes on cash
|
|
(275
|
)
|
|
—
|
|
|
—
|
|
|||
Net (decrease) increase in cash and cash equivalents
|
|
$
|
(28,521
|
)
|
|
$
|
1,466
|
|
|
$
|
92,434
|
|
|
|
|
||||||||||||||||||||||||||
Contractual Obligations
|
|
Total
|
|
2016
|
|
2017
|
|
2018
|
|
2019
|
|
2020
|
|
Later
|
||||||||||||||
Operating lease obligations
|
|
$
|
15,174
|
|
|
$
|
2,285
|
|
|
$
|
2,322
|
|
|
$
|
2,306
|
|
|
$
|
2,181
|
|
|
$
|
2,146
|
|
|
$
|
3,934
|
|
Debt obligations
(1)
|
|
215,170
|
|
|
4,025
|
|
|
4,025
|
|
|
4,025
|
|
|
203,095
|
|
|
—
|
|
|
—
|
|
|||||||
Capital lease obligations
(2)
|
|
6,143
|
|
|
5,874
|
|
|
269
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Purchase obligations
|
|
2,000
|
|
|
2,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Total contractual obligations
|
|
$
|
238,487
|
|
|
$
|
14,184
|
|
|
$
|
6,616
|
|
|
$
|
6,331
|
|
|
$
|
205,276
|
|
|
$
|
2,146
|
|
|
$
|
3,934
|
|
|
|
|
|
|
(1)
|
The interest rate on the convertible debt is 2% per annum. We have included future payments of interest on the long-term debt in our obligations.
|
(2)
|
The effective interest rate on the capital lease obligations is 13-17%. We have included future payments of interest on the capital leases in our obligations.
|
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2015 |
|
December 31,
2014 |
||||
(In thousands, except share and per share data)
|
|
|
|
||||
ASSETS
|
|
|
|
||||
Current Assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
122,672
|
|
|
$
|
151,193
|
|
Accounts receivable, net
|
48,387
|
|
|
39,882
|
|
||
Inventories, net
|
14,043
|
|
|
13,099
|
|
||
Prepaid expenses and other current assets
|
5,659
|
|
|
4,022
|
|
||
Total current assets
|
190,761
|
|
|
208,196
|
|
||
Property and equipment, net
|
41,793
|
|
|
37,069
|
|
||
Intangible assets, net
|
2,721
|
|
|
14,064
|
|
||
Goodwill
|
39,747
|
|
|
37,536
|
|
||
Other assets
|
104
|
|
|
317
|
|
||
Total assets
|
$
|
275,126
|
|
|
$
|
297,182
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current Liabilities
|
|
|
|
||||
Accounts payable
|
$
|
18,649
|
|
|
$
|
14,659
|
|
Accrued expenses and other current liabilities
|
38,627
|
|
|
24,703
|
|
||
Deferred revenue
|
2,361
|
|
|
1,554
|
|
||
Current portion of capital lease obligations
|
5,519
|
|
|
3,380
|
|
||
Total current liabilities
|
65,156
|
|
|
44,296
|
|
||
Capital lease obligations
|
269
|
|
|
2,263
|
|
||
Long-term debt, net of discount
|
171,698
|
|
|
164,020
|
|
||
Other long-term liabilities
|
3,952
|
|
|
2,774
|
|
||
Total liabilities
|
241,075
|
|
|
213,353
|
|
||
Commitments and contingencies (Note 13)
|
|
|
|
||||
Stockholders’ Equity
|
|
|
|
||||
Preferred stock, $.001 par value:
|
|
|
|
||||
Authorized: 5,000,000 shares at December 31, 2015 and 2014.
Issued and outstanding: zero shares at December 31, 2015 and 2014.
|
—
|
|
|
—
|
|
||
Common stock, $.001 par value:
|
|
|
|
||||
Authorized: 100,000,000 shares at December 31, 2015 and 2014.
Issued and outstanding: 56,954,830 and 56,299,022 shares at December 31, 2015 and 2014, respectively. |
57
|
|
|
56
|
|
||
Additional paid-in capital
|
686,193
|
|
|
661,811
|
|
||
Accumulated other comprehensive loss
|
(654
|
)
|
|
(13
|
)
|
||
Accumulated deficit
|
(651,545
|
)
|
|
(578,025
|
)
|
||
Total stockholders’ equity
|
34,051
|
|
|
83,829
|
|
||
Total liabilities and stockholders’ equity
|
$
|
275,126
|
|
|
$
|
297,182
|
|
|
|
Years Ended December 31,
|
||||||||||
(In thousands, except share and per share data)
|
|
2015
|
|
2014
|
|
2013
|
||||||
Revenue
|
|
$
|
324,225
|
|
|
$
|
288,720
|
|
|
$
|
247,084
|
|
Cost of revenue
|
|
176,071
|
|
|
145,432
|
|
|
134,683
|
|
|||
Gross profit
|
|
148,154
|
|
|
143,288
|
|
|
112,401
|
|
|||
Operating expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
43,208
|
|
|
27,900
|
|
|
21,765
|
|
|||
Sales and marketing
|
|
88,352
|
|
|
60,844
|
|
|
55,694
|
|
|||
General and administrative
|
|
77,359
|
|
|
66,841
|
|
|
64,077
|
|
|||
Total operating expenses
|
|
208,919
|
|
|
155,585
|
|
|
141,536
|
|
|||
Operating loss
|
|
(60,765
|
)
|
|
(12,297
|
)
|
|
(29,135
|
)
|
|||
Interest expense
|
|
(12,580
|
)
|
|
(14,687
|
)
|
|
(16,889
|
)
|
|||
Other income (expense), net
|
|
116
|
|
|
(1,171
|
)
|
|
1,475
|
|
|||
Loss on extinguishment of long-term debt
|
|
—
|
|
|
(23,203
|
)
|
|
(325
|
)
|
|||
Interest and other expense, net
|
|
(12,464
|
)
|
|
(39,061
|
)
|
|
(15,739
|
)
|
|||
Loss before income taxes
|
|
(73,229
|
)
|
|
(51,358
|
)
|
|
(44,874
|
)
|
|||
Income tax expense
|
|
(291
|
)
|
|
(142
|
)
|
|
(100
|
)
|
|||
Net loss
|
|
$
|
(73,520
|
)
|
|
$
|
(51,500
|
)
|
|
$
|
(44,974
|
)
|
Net loss per share basic and diluted
|
|
$
|
(1.29
|
)
|
|
$
|
(0.93
|
)
|
|
$
|
(0.83
|
)
|
Weighted-average number of shares used in calculating net loss per share
|
|
56,785,646
|
|
|
55,628,542
|
|
|
54,010,887
|
|
|
|
Years Ended December 31,
|
||||||||||
(In thousands)
|
|
2015
|
|
2014
|
|
2013
|
||||||
Net loss
|
|
$
|
(73,520
|
)
|
|
$
|
(51,500
|
)
|
|
$
|
(44,974
|
)
|
Other comprehensive loss, net of tax
|
|
|
|
|
|
|
||||||
Foreign currency translation adjustment, net of tax
|
|
(641
|
)
|
|
6
|
|
|
(19
|
)
|
|||
Total other comprehensive (loss) income, net of tax
|
|
(641
|
)
|
|
6
|
|
|
(19
|
)
|
|||
Total comprehensive loss
|
|
$
|
(74,161
|
)
|
|
$
|
(51,494
|
)
|
|
$
|
(44,993
|
)
|
|
Common Stock
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Accumulated Other Comprehensive Loss
|
|
Total
Stockholders’
Equity
|
|||||||||||||
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balance at December 31, 2012
|
48,359,063
|
|
|
$
|
48
|
|
|
$
|
525,679
|
|
|
$
|
(481,551
|
)
|
|
|
|
$
|
44,176
|
|
||
Exercise of options to purchase common stock
|
872,073
|
|
|
1
|
|
|
9,479
|
|
|
—
|
|
|
|
|
9,480
|
|
||||||
Issuance for employee stock purchase plan
|
12,970
|
|
|
—
|
|
|
445
|
|
|
—
|
|
|
|
|
445
|
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
12,616
|
|
|
—
|
|
|
|
|
12,616
|
|
||||||
Restricted stock units vested, net of shares withheld for taxes
|
217,281
|
|
|
—
|
|
|
(3,265
|
)
|
|
—
|
|
|
|
|
(3,265
|
)
|
||||||
Issuance of common stock, net of offering costs of $5.0 million
|
4,715,000
|
|
|
5
|
|
|
92,807
|
|
|
—
|
|
|
|
|
92,812
|
|
||||||
Exercise of warrants to purchase common stock
|
47,392
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
—
|
|
||||||
Issuance of common stock pursuant to conversion of debt
|
646,645
|
|
|
1
|
|
|
13,325
|
|
|
—
|
|
|
|
|
13,326
|
|
||||||
Foreign currency translation adjustment, net of tax
|
|
|
|
|
|
|
|
|
(19
|
)
|
|
(19
|
)
|
|||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(44,974
|
)
|
|
|
|
(44,974
|
)
|
||||||
Balance at December 31, 2013
|
54,870,424
|
|
|
$
|
55
|
|
|
$
|
651,086
|
|
|
$
|
(526,525
|
)
|
|
$
|
(19
|
)
|
|
$
|
124,597
|
|
Exercise of options to purchase common stock
|
754,522
|
|
|
1
|
|
|
11,084
|
|
|
—
|
|
|
|
|
11,085
|
|
||||||
Issuance for employee stock purchase plan
|
13,620
|
|
|
—
|
|
|
583
|
|
|
—
|
|
|
|
|
583
|
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
22,432
|
|
|
—
|
|
|
|
|
22,432
|
|
||||||
Restricted stock units vested, net of shares withheld for taxes
|
311,921
|
|
|
—
|
|
|
(8,665
|
)
|
|
—
|
|
|
|
|
(8,665
|
)
|
||||||
Net impact of conversion of 3.75% Notes
|
—
|
|
|
—
|
|
|
(61,728
|
)
|
|
—
|
|
|
|
|
(61,728
|
)
|
||||||
Allocation to equity for conversion feature on 2% Notes, net of issuance costs
|
—
|
|
|
—
|
|
|
34,455
|
|
|
—
|
|
|
|
|
34,455
|
|
||||||
Issuance of common stock pursuant to conversion of debt
|
348,535
|
|
|
|
|
12,564
|
|
|
—
|
|
|
|
|
12,564
|
|
|||||||
Foreign currency translation adjustment, net of tax
|
|
|
|
|
|
|
|
|
6
|
|
|
6
|
|
|||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(51,500
|
)
|
|
|
|
$
|
(51,500
|
)
|
|||||
Balance at December 31, 2014
|
56,299,022
|
|
|
$
|
56
|
|
|
$
|
661,811
|
|
|
$
|
(578,025
|
)
|
|
$
|
(13
|
)
|
|
$
|
83,829
|
|
Exercise of options to purchase common stock
|
449,149
|
|
|
1
|
|
|
7,198
|
|
|
|
|
|
|
7,199
|
|
|||||||
Issuance for employee stock purchase plan
|
22,039
|
|
|
—
|
|
|
652
|
|
|
|
|
|
|
652
|
|
|||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
19,178
|
|
|
|
|
|
|
19,178
|
|
|||||||
Restricted stock units vested, net of shares withheld for taxes
|
184,620
|
|
|
—
|
|
|
(2,646
|
)
|
|
|
|
|
|
(2,646
|
)
|
|||||||
Foreign currency translation adjustment, net of tax
|
|
|
|
|
|
|
|
|
(641
|
)
|
|
(641
|
)
|
|||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(73,520
|
)
|
|
—
|
|
|
(73,520
|
)
|
|||||
Balance at December 31, 2015
|
56,954,830
|
|
|
$
|
57
|
|
|
$
|
686,193
|
|
|
$
|
(651,545
|
)
|
|
$
|
(654
|
)
|
|
$
|
34,051
|
|
|
|
Years Ended December 31,
|
||||||||||
(In thousands)
|
|
2015
|
|
2014
|
|
2013
|
||||||
Cash flows from operating activities
|
|
|
|
|
|
|
||||||
Net loss
|
|
$
|
(73,520
|
)
|
|
$
|
(51,500
|
)
|
|
$
|
(44,974
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities
|
|
|
|
|
|
|
||||||
Depreciation and amortization
|
|
15,838
|
|
|
12,223
|
|
|
11,806
|
|
|||
Non-cash interest and other expense
|
|
7,678
|
|
|
10,253
|
|
|
9,731
|
|
|||
Stock-based compensation expense
|
|
19,178
|
|
|
22,519
|
|
|
12,683
|
|
|||
Loss on extinguishment of debt
|
|
—
|
|
|
23,203
|
|
|
325
|
|
|||
Provision for bad debts
|
|
1,184
|
|
|
3,254
|
|
|
4,741
|
|
|||
Impairment and other charges
|
|
9,086
|
|
|
—
|
|
|
2,511
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
||||||
Accounts receivable
|
|
(9,793
|
)
|
|
(10,069
|
)
|
|
(4,514
|
)
|
|||
Inventories
|
|
(722
|
)
|
|
(3,635
|
)
|
|
5,403
|
|
|||
Deferred revenue
|
|
809
|
|
|
654
|
|
|
(4,545
|
)
|
|||
Prepaid expenses and other assets
|
|
(1,460
|
)
|
|
662
|
|
|
(320
|
)
|
|||
Accounts payable, accrued expenses and other current liabilities
|
|
17,986
|
|
|
525
|
|
|
10,425
|
|
|||
Other long-term liabilities
|
|
1,184
|
|
|
831
|
|
|
76
|
|
|||
Net cash (used in) provided by operating activities
|
|
(12,552
|
)
|
|
8,920
|
|
|
3,348
|
|
|||
Cash flows from investing activities
|
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
|
(10,608
|
)
|
|
(11,486
|
)
|
|
(7,307
|
)
|
|||
Acquisition of Canadian distribution business
|
|
(4,715
|
)
|
|
—
|
|
|
—
|
|
|||
Net cash used in investing activities
|
|
(15,323
|
)
|
|
(11,486
|
)
|
|
(7,307
|
)
|
|||
Cash flows from financing activities
|
|
|
|
|
|
|
||||||
Principal payments of capital lease obligations
|
|
(5,576
|
)
|
|
(3,858
|
)
|
|
(994
|
)
|
|||
Proceeds from issuance of long-term debt, net of issuance costs
|
|
—
|
|
|
194,490
|
|
|
—
|
|
|||
Repayment of long-term debt
|
|
—
|
|
|
(189,521
|
)
|
|
(2,000
|
)
|
|||
Proceeds from issuance of common stock, net of offering costs
|
|
7,851
|
|
|
11,586
|
|
|
102,652
|
|
|||
Payment of withholding taxes in connection with vesting of restricted stock units
|
|
(2,646
|
)
|
|
(8,665
|
)
|
|
(3,265
|
)
|
|||
Net cash (used in) provided by financing activities
|
|
(371
|
)
|
|
4,032
|
|
|
96,393
|
|
|||
Effect of exchange rate changes on cash
|
|
(275
|
)
|
|
—
|
|
|
—
|
|
|||
Net (decrease) increase in cash and cash equivalents
|
|
(28,521
|
)
|
|
1,466
|
|
|
92,434
|
|
|||
Cash and cash equivalents, beginning of period
|
|
151,193
|
|
|
149,727
|
|
|
57,293
|
|
|||
Cash and cash equivalents, end of period
|
|
$
|
122,672
|
|
|
$
|
151,193
|
|
|
$
|
149,727
|
|
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
||||||
Cash paid for interest
|
|
$
|
4,025
|
|
|
$
|
4,657
|
|
|
$
|
5,704
|
|
Cash paid for taxes
|
|
$
|
109
|
|
|
$
|
124
|
|
|
$
|
321
|
|
Non-cash investing and financing activities
|
|
|
|
|
|
|
||||||
Allocation to equity for conversion feature for the 2% Notes
|
|
$
|
—
|
|
|
$
|
35,638
|
|
|
$
|
—
|
|
Common stock issued in exchange for 3.75% Convertible Senior Notes
|
|
$
|
—
|
|
|
$
|
12,564
|
|
|
$
|
13,000
|
|
Purchases of property and equipment under capital lease
|
|
$
|
5,721
|
|
|
$
|
1,474
|
|
|
$
|
9,021
|
|
|
Years Ended December 31,
|
||||||
|
2015
|
|
2014
|
||||
(In thousands)
|
|
|
|
||||
Goodwill:
|
|
|
|
||||
Beginning balance
|
$
|
37,536
|
|
|
$
|
37,536
|
|
Goodwill as a result of acquisition
|
2,403
|
|
|
—
|
|
||
Foreign currency adjustment
|
(192
|
)
|
|
—
|
|
||
Ending balance
|
$
|
39,747
|
|
|
$
|
37,536
|
|
•
|
The evidence of an arrangement generally consists of a physician order form, a patient information form and, if applicable, third-party insurance approval for sales directly to patients or a purchase order for sales to a third-party distributor.
|
•
|
Transfer of title and risk and rewards of ownership are passed to the patient or third-party distributor upon shipment of the products.
|
•
|
The selling prices for all sales are fixed and agreed with the patient or third-party distributor and, if applicable, the patient’s third-party insurance provider(s) prior to shipment and are based on established list prices or, in the case of certain third-party insurers, contractually agreed upon prices. Provisions for discounts, rebates and other adjustments to customers are established as a reduction to revenue in the same period the related sales are recorded.
|
Cash
|
|
$
|
5,000
|
|
Employment liability transfer fee
|
|
(285
|
)
|
|
Total consideration
|
|
$
|
4,715
|
|
Goodwill
|
|
$
|
2,403
|
|
Contractual relationships
|
|
2,100
|
|
|
Inventory step up
|
|
230
|
|
|
Assumed liabilities
|
|
(18
|
)
|
|
|
|
$
|
4,715
|
|
•
|
Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities.
|
•
|
Cost approach, which is based on the cost to acquire or construct comparable assets less an allowance for functional and/or economic obsolescence.
|
•
|
Income approach, which is based on the present value of the future stream of net cash flows.
|
|
Fair Value Measurements
|
||||||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
December 31, 2015
|
|
|
|
|
|
|
|
||||||||
Recurring Fair Value Measurements:
|
|
|
|
|
|
|
|
||||||||
Cash Equivalents - Money Market Funds
|
$
|
98,223
|
|
|
$
|
98,223
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Non-Recurring Fair Value Measurements:
|
|
|
|
|
|
|
|
||||||||
Long-lived assets held and used
(1)
|
$
|
1,800
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,800
|
|
December 31, 2014
|
|
|
|
|
|
|
|
||||||||
Recurring Fair Value Measurements:
|
|
|
|
|
|
|
|
||||||||
Cash Equivalents - Money Market Funds
|
$
|
123,141
|
|
|
$
|
123,141
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
(1)
|
Long-lived assets held and used relate to the asset group of the Neighborhood Diabetes business which consists of definite lived intangible assets and property and equipment. During the fourth quarter, the Company recognized an impairment charge on this asset group totaling $9.1 million, which represented the difference between the fair value of the asset group and the carrying value. As a result of the impairment the asset group has been recorded at fair value as of December 31, 2015. The fair value for the asset group was determined using the direct cash flows expected to be received from the disposition of the asset group, which was completed in February 2016 (level 3 input).
|
|
December 31, 2015
|
|
December 31, 2014
|
||||||||||||
|
Carrying
Value
|
|
Estimated Fair
Value
|
|
Carrying
Value |
|
Estimated Fair
Value |
||||||||
2% Convertible Senior Notes
|
$
|
171,698
|
|
|
$
|
207,882
|
|
|
$
|
164,020
|
|
|
$
|
237,475
|
|
|
As of
|
||||||
|
December 31,
2015 |
|
December 31, 2014
|
||||
Principal amount of the 2% Convertible Senior Notes
|
$
|
201,250
|
|
|
$
|
201,250
|
|
Unamortized debt discount
|
(25,704
|
)
|
|
(32,256
|
)
|
||
Deferred financing costs
|
$
|
(3,848
|
)
|
|
$
|
(4,974
|
)
|
Long-term debt, net of discount
|
$
|
171,698
|
|
|
$
|
164,020
|
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Contractual coupon interest
|
$
|
4,025
|
|
|
$
|
4,657
|
|
|
$
|
5,704
|
|
Accretion of debt discount
|
6,552
|
|
|
8,007
|
|
|
10,492
|
|
|||
Amortization of debt issuance costs
|
1,126
|
|
|
895
|
|
|
590
|
|
|||
Loss on extinguishment of long-term debt
|
—
|
|
|
23,203
|
|
|
325
|
|
|||
Total interest and other expense
|
$
|
11,703
|
|
|
$
|
36,762
|
|
|
$
|
17,111
|
|
|
As of
|
||||||
|
December 31, 2015
|
|
December 31, 2014
|
||||
Manufacturing equipment
|
$
|
13,705
|
|
|
$
|
7,984
|
|
Less: Accumulated amortization
|
(4,346
|
)
|
|
(1,885
|
)
|
||
Total
|
$
|
9,359
|
|
|
$
|
6,099
|
|
Years Ending December 31,
|
Minimum Lease
Payments
|
||
2016
|
$
|
5,874
|
|
2017
|
269
|
|
|
Total future minimum lease payments
|
$
|
6,143
|
|
Interest expense
|
(355
|
)
|
|
Total capital lease obligations
|
$
|
5,788
|
|
|
Years Ended December 31,
|
||||||
|
2015
|
|
2014
|
2013
|
|||
3.75% Convertible Senior Notes
|
—
|
|
|
—
|
|
5,487,642
|
|
2.00% Convertible Senior Notes
|
4,327,257
|
|
|
4,327,257
|
|
—
|
|
Unvested restricted stock units
|
811,965
|
|
|
746,612
|
|
1,011,893
|
|
Outstanding options
|
2,999,199
|
|
|
1,847,669
|
|
1,828,613
|
|
Total dilutive common shares
|
8,138,421
|
|
|
6,921,538
|
|
8,328,148
|
|
|
As of
|
||||||
December 31,
2015 |
|
December 31, 2014
|
|||||
Trade receivables
|
$
|
52,841
|
|
|
$
|
45,719
|
|
Allowance for doubtful accounts
|
(4,454
|
)
|
|
(5,837
|
)
|
||
Total accounts receivable
|
$
|
48,387
|
|
|
$
|
39,882
|
|
|
As of
|
||||||
December 31,
2015 |
|
December 31, 2014
|
|||||
Raw materials
|
$
|
632
|
|
|
$
|
853
|
|
Work-in-process
|
1,960
|
|
|
254
|
|
||
Finished goods, net
|
11,451
|
|
|
11,992
|
|
||
Total inventories
|
$
|
14,043
|
|
|
$
|
13,099
|
|
|
Estimated
Useful Life
(Years)
|
|
As of
December 31,
|
||||||
|
2015
|
|
2014
|
||||||
Machinery and equipment
|
2-5
|
|
$
|
49,059
|
|
|
$
|
35,690
|
|
Lab equipment
|
2-3
|
|
1,615
|
|
|
1,585
|
|
||
Computers
|
3
|
|
2,067
|
|
|
4,511
|
|
||
Software
|
3
|
|
2,566
|
|
|
5,618
|
|
||
Office furniture and fixtures
|
3-5
|
|
1,468
|
|
|
1,253
|
|
||
Leasehold improvement
|
*
|
|
927
|
|
|
826
|
|
||
Construction in process
|
—
|
|
12,275
|
|
|
10,502
|
|
||
Total property and equipment
|
|
|
$
|
69,977
|
|
|
$
|
59,985
|
|
Less: accumulated depreciation
|
|
|
(28,184
|
)
|
|
(22,916
|
)
|
||
Total property and equipment
|
|
|
$
|
41,793
|
|
|
$
|
37,069
|
|
|
|
|
|
|
|
As of
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Property and equipment:
|
|
|
|
||||
U.S. property and equipment
|
$
|
19,267
|
|
|
$
|
22,814
|
|
Non-U.S. property and equipment
|
50,710
|
|
|
37,171
|
|
||
Less: accumulated depreciation
|
(28,184
|
)
|
|
(22,916
|
)
|
||
Total property and equipment
|
$
|
41,793
|
|
|
$
|
37,069
|
|
|
As of
|
||||||||||||||||||||||
December 31, 2015
|
|
December 31, 2014
|
|||||||||||||||||||||
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net Book Value
|
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net Book Value
|
||||||||||||
Customer and contractual relationships, net
(1)
|
$
|
3,399
|
|
|
$
|
(1,000
|
)
|
|
$
|
2,399
|
|
|
$
|
30,100
|
|
|
$
|
(18,167
|
)
|
|
$
|
11,933
|
|
Tradename
|
322
|
|
|
—
|
|
|
322
|
|
|
2,800
|
|
|
(669
|
)
|
|
2,131
|
|
||||||
Total intangible assets
(2)
|
$
|
3,721
|
|
|
$
|
(1,000
|
)
|
|
$
|
2,721
|
|
|
$
|
32,900
|
|
|
$
|
(18,836
|
)
|
|
$
|
14,064
|
|
|
|
|
|
|
(1)
|
Includes foreign currency translation loss of approximately
$0.2 million
.
|
(2)
|
As a result of the impairment recorded on the Neighborhood Diabetes asset group, the Company recorded an impairment charge of approximately
$9.0 million
on the related Neighborhood Diabetes intangible assets. This resulted in the gross carrying value and accumulated amortization of the Neighborhood Diabetes intangibles being reduced by $31,112 and $22,087 respectively at December 31, 2015.
|
|
Amortization Expense
|
||||||||||
Years Ending December 31,
|
Customer and Contractual Relationships
|
|
Tradename
|
|
Total
|
||||||
2016
|
$
|
831
|
|
|
$
|
31
|
|
|
$
|
862
|
|
2017
|
507
|
|
|
31
|
|
|
538
|
|
|||
2018
|
417
|
|
|
31
|
|
|
448
|
|
|||
2019
|
341
|
|
|
31
|
|
|
372
|
|
|||
2020
|
237
|
|
|
31
|
|
|
268
|
|
|||
Thereafter
|
66
|
|
|
167
|
|
|
233
|
|
|||
Total
|
$
|
2,399
|
|
|
$
|
322
|
|
|
$
|
2,721
|
|
|
Years Ended December 31,
|
||||||
|
2015
|
|
2014
|
||||
Employee compensation and related items
|
$
|
17,487
|
|
|
$
|
10,243
|
|
Professional and consulting services
|
5,661
|
|
|
4,373
|
|
||
Sales and use tax
|
1,484
|
|
|
3,843
|
|
||
Supplier charges
|
5,712
|
|
|
1,852
|
|
||
Warranty
|
1,592
|
|
|
981
|
|
||
Other
|
6,691
|
|
|
3,411
|
|
||
Total accrued expenses and other current liabilities
|
$
|
38,627
|
|
|
$
|
24,703
|
|
|
Years Ended December 31,
|
||||||
|
2015
|
|
2014
|
||||
Balance at the beginning of the period
|
$
|
2,614
|
|
|
$
|
3,090
|
|
Warranty expense
|
4,964
|
|
|
1,665
|
|
||
Warranty claims settled
|
(3,426
|
)
|
|
(2,141
|
)
|
||
Balance at the end of the period
|
$
|
4,152
|
|
|
$
|
2,614
|
|
|
As of
|
||||||
|
December 31,
2015 |
|
December 31,
2014 |
||||
Composition of balance:
|
|
|
|
||||
Short-term
|
$
|
1,592
|
|
|
$
|
981
|
|
Long-term
|
2,560
|
|
|
1,633
|
|
||
|
$
|
4,152
|
|
|
$
|
2,614
|
|
Years Ending December 31,
|
Minimum Lease
Payments
|
||
2016
|
2,285
|
|
|
2017
|
2,322
|
|
|
2018
|
2,306
|
|
|
2019
|
2,181
|
|
|
2020
|
2,146
|
|
|
Thereafter
|
3,934
|
|
|
Total
|
$
|
15,174
|
|
•
|
Expected volatility measures the amount that a stock price has fluctuated or is expected to fluctuate during a period and is computed over expected terms based upon the historical volatility of the Company's stock.
|
•
|
The expected life of the awards is estimated based on the midpoint scenario, which combines historical exercise data with hypothetical exercise data for outstanding options, as the Company believes this data currently represents the best estimate of the expected life of a new employee option. The Company stratifies its employee population into two groups based upon organizational hierarchy.
|
•
|
The risk-free interest rate assumption is based on U.S. Treasury zero-coupon issues with remaining terms similar to the expected term on the options.
|
•
|
The dividend yield assumption is based on Company history and expectation of paying no dividends. The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future, and, therefore, used an expected dividend yield of zero in the valuation.
|
|
Years Ended December 31,
|
||||
|
2015
|
|
2014
|
|
2013
|
Risk-free interest rate
|
1.16% - 1.75%
|
|
0.12% - 1.98%
|
|
0.93% - 1.91%
|
Expected term (in years)
|
4.86 - 5.25
|
|
1.0 - 6.25
|
|
6.25
|
Dividend yield
|
—
|
|
—
|
|
—
|
Expected volatility
|
37% - 38%
|
|
37% - 63%
|
|
63% - 66%
|
|
Number of
Options (#)
|
|
Weighted Average
Exercise Price ($)
|
|
Aggregate
Intrinsic
Value ($)
|
|||||
|
|
|
|
|
(In thousands)
|
|||||
Balance, December 31, 2014
|
1,847,669
|
|
|
$
|
26.99
|
|
|
|
||
Granted
|
2,002,141
|
|
|
32.48
|
|
|
|
|||
Exercised
(1)
|
(449,149
|
)
|
|
16.03
|
|
|
$
|
8,582
|
|
|
Canceled
|
(401,462
|
)
|
|
33.20
|
|
|
|
|||
Balance, December 31, 2015
|
2,999,199
|
|
|
$
|
31.37
|
|
|
$
|
20,743
|
|
Vested, December 31, 2015
(2)
|
947,909
|
|
|
$
|
27.91
|
|
|
$
|
9,613
|
|
Vested and expected to vest, December 31, 2015
(2)(3)
|
2,685,514
|
|
|
|
|
$
|
18,899
|
|
|
|
|
|
|
(1)
|
The aggregate intrinsic value was calculated based on the positive difference between the estimated fair value of the Company’s common stock as of the date of exercise and the exercise price of the underlying options. The aggregate intrinsic value of options exercised in the years ended December 31, 2015, 2014 and 2013 was
$8.6 million
,
$20.4 million
and
$17.8 million
, respectively,
|
(2)
|
The aggregate intrinsic value was calculated based on the positive difference between the estimated fair value of the Company’s common stock as of
December 31, 2015
, and the exercise price of the underlying options.
|
(3)
|
Represents the number of vested options as of
December 31, 2015
, plus the number of unvested options expected to vest as of
December 31, 2015
, based on the unvested options outstanding at
December 31, 2015
, adjusted for the estimated forfeiture.
|
|
Number of
Shares (#)
|
|
Weighted
Average
Fair Value ($)
|
|||
Balance, December 31, 2014
|
746,612
|
|
|
$
|
31.40
|
|
Granted
|
708,446
|
|
|
30.37
|
|
|
Vested
|
(271,118
|
)
|
|
28.96
|
|
|
Forfeited
|
(371,975
|
)
|
|
33.00
|
|
|
Balance, December 31, 2015
|
811,965
|
|
|
$
|
30.58
|
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(76
|
)
|
State
|
73
|
|
|
58
|
|
|
88
|
|
|||
Non-U.S.
|
321
|
|
|
3
|
|
|
4
|
|
|||
Total current expense
|
394
|
|
|
61
|
|
|
16
|
|
|||
Deferred:
|
|
|
|
|
|
||||||
Federal
|
76
|
|
|
76
|
|
|
76
|
|
|||
State
|
2
|
|
|
5
|
|
|
8
|
|
|||
Non-U.S.
|
(181
|
)
|
|
—
|
|
|
—
|
|
|||
Total deferred expense
|
(103
|
)
|
|
81
|
|
|
84
|
|
|||
Total income tax expense
|
$
|
291
|
|
|
$
|
142
|
|
|
100
|
|
|
Year Ended December 31,
|
||||||
|
2015
|
|
2014
|
||||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carryforwards
|
$
|
178,048
|
|
|
$
|
161,888
|
|
Start up expenditures
|
1,168
|
|
|
1,416
|
|
||
Tax credits
|
8,173
|
|
|
6,968
|
|
||
Provision for bad debts
|
1,981
|
|
|
2,174
|
|
||
Depreciation and amortization
|
2,528
|
|
|
897
|
|
||
Other
|
13,102
|
|
|
9,777
|
|
||
Total deferred tax assets
|
$
|
205,000
|
|
|
$
|
183,120
|
|
Deferred tax liabilities:
|
|
|
|
||||
Prepaids
|
$
|
(1,249
|
)
|
|
$
|
(935
|
)
|
Amortization of acquired intangibles
|
(662
|
)
|
|
(5,218
|
)
|
||
Amortization of debt discount
|
(9,503
|
)
|
|
(11,947
|
)
|
||
Goodwill
|
(383
|
)
|
|
(304
|
)
|
||
Total deferred tax liabilities
|
$
|
(11,797
|
)
|
|
$
|
(18,404
|
)
|
Valuation allowance
|
$
|
(193,405
|
)
|
|
$
|
(165,020
|
)
|
Net deferred tax liabilities
|
$
|
(202
|
)
|
|
$
|
(304
|
)
|
|
December 31,
2015 |
||
ASSETS
(1)
|
|
||
Current assets
|
$
|
9,252
|
|
Total assets
|
11,208
|
|
|
LIABILITIES
(1)
|
|
||
Current liabilities
|
$
|
5,319
|
|
Total liabilities
|
5,703
|
|
|
|
|
|
|
(1)
|
These amounts represent the direct assets and liabilities, including intangible assets, that are that are expected to be transferred as part of the sale.
|
|
2015 Quarters ended
|
||||||||||||||
|
December 31
(1)
|
|
September 30
|
|
June 30
|
|
March 31
|
||||||||
|
(In thousands, except per share data)
|
||||||||||||||
Revenue
|
$
|
100,119
|
|
|
$
|
87,303
|
|
|
$
|
75,588
|
|
|
$
|
61,215
|
|
Gross profit
|
$
|
45,321
|
|
|
$
|
35,651
|
|
|
$
|
34,375
|
|
|
$
|
32,807
|
|
Net loss
|
$
|
(27,327
|
)
|
|
$
|
(18,927
|
)
|
|
$
|
(15,432
|
)
|
|
$
|
(11,834
|
)
|
Net loss per share
|
$
|
(0.48
|
)
|
|
$
|
(0.33
|
)
|
|
$
|
(0.27
|
)
|
|
$
|
(0.21
|
)
|
|
|
|
|
|
(1)
|
Included in net loss for the fourth quarter of 2015 was a charge of
$9.1 million
related to the impairment of the Neighborhood Diabetes asset group.
|
|
2014 Quarters ended
|
||||||||||||||
|
December 31
|
|
September 30
|
|
June 30
(2)
|
|
March 31
|
||||||||
|
(In thousands, except per share data)
|
||||||||||||||
Revenue
|
$
|
72,561
|
|
|
$
|
74,985
|
|
|
$
|
72,013
|
|
|
$
|
69,161
|
|
Gross profit
|
$
|
36,673
|
|
|
$
|
38,042
|
|
|
$
|
35,765
|
|
|
$
|
32,808
|
|
Net loss
|
$
|
(5,400
|
)
|
|
$
|
(10,845
|
)
|
|
$
|
(29,111
|
)
|
|
$
|
(6,144
|
)
|
Net loss per share
|
$
|
(0.10
|
)
|
|
$
|
(0.19
|
)
|
|
$
|
(0.53
|
)
|
|
$
|
(0.11
|
)
|
|
|
|
|
|
(2)
|
Included in net loss for the second and third quarters of 2014 was a charge of
$18.9 million
and
$4.3 million
, respectively, related to the loss from extinguishment of long-term debt.
|
Description
|
Balance at
Beginning of
Period
|
|
Additions Charged
to Costs and
Expenses
|
|
Deductions
|
|
Balance at
End
of Period
|
||||||||
|
(In thousands)
|
||||||||||||||
Year Ended December 31, 2015
|
|
|
|
|
|
|
|
||||||||
Allowance for doubtful accounts
|
$
|
5,837
|
|
|
$
|
1,184
|
|
|
$
|
2,567
|
|
|
$
|
4,454
|
|
Deferred tax valuation allowance
|
165,020
|
|
|
28,418
|
|
|
33
|
|
|
193,405
|
|
||||
Year Ended December 31, 2014
|
|
|
|
|
|
|
|
||||||||
Allowance for doubtful accounts
|
$
|
7,133
|
|
|
$
|
3,254
|
|
|
$
|
4,550
|
|
|
$
|
5,837
|
|
Deferred tax valuation allowance
|
158,323
|
|
|
21,070
|
|
|
14,373
|
|
|
165,020
|
|
||||
Year Ended December 31, 2013
|
|
|
|
|
|
|
|
||||||||
Allowance for doubtful accounts
|
$
|
6,627
|
|
|
$
|
4,741
|
|
|
$
|
4,235
|
|
|
$
|
7,133
|
|
Deferred tax valuation allowance
|
145,927
|
|
|
32,050
|
|
|
19,654
|
|
|
158,323
|
|
|
INSULET CORPORATION
(Registrant)
|
|
|
Date: February 29, 2016
|
/s/ Patrick J. Sullivan
|
|
Patrick J. Sullivan
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
Date: February 29, 2016
|
/s/ Michael L. Levitz
|
|
Michael L. Levitz
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer)
|
Signature
|
|
Title
|
/s/ Patrick J. Sullivan
|
|
President, Chief Executive Officer and Director
|
Patrick J. Sullivan
|
|
(Principal Executive Officer)
|
|
|
|
/s/ Michael L. Levitz
|
|
Chief Financial Officer
|
Michael L. Levitz
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
/s/ Sally Crawford
|
|
|
Sally Crawford
|
|
Director
|
|
|
|
/s/ John Fallon, M.D.
|
|
|
John Fallon, M.D.
|
|
Director
|
|
|
|
/s/ Dr. Jessica Hopfield
|
|
|
Dr. Jessica Hopfield
|
|
Director
|
|
|
|
/s/ David A. Lemoine
|
|
|
David Lemoine
|
|
Director
|
|
|
|
/s/ Timothy J. Scannell
|
|
|
Timothy J. Scannell
|
|
Director
|
|
|
|
/s/ Steven Sobieski
|
|
|
Steven Sobieski
|
|
Director
|
|
|
|
/s/ Regina Sommer
|
|
|
Regina Sommer
|
|
Director
|
|
|
|
/s/ Joseph Zakrzewski
|
|
|
Joseph Zakrzewski
|
|
Director
|
Number
|
Description
|
|
|
10.21(22)
|
Amendment No. 1 to Distribution Agreement dated April 10, 2012 by and between Insulet Corporation and Ypsomed Distribution AG
|
|
|
10.22(22)
|
Amendment No. 3 to Development and License Agreement, dated as of April 5, 2011 by and between ADC and Insulet Corporation
|
|
|
10.23(22)
|
Amendment No. 4 to Development and License Agreement, dated as of March 29, 2012 by and between ADC and Insulet Corporation
|
|
|
10.24(23)
|
Amendment No. 5 to Development and License Agreement, dated as of June 21, 2012 by and between ADC and Insulet Corporation
|
|
|
10.25(24)+
|
Settlement and Cross-License Agreement, dated September 18, 2013, by and among the Company and Medtronic Inc., Medtronic MiniMed Inc., and Medtronic Puerto Rico Operations Co.
|
|
|
10.26(31)
|
Form of Time Vesting Restricted Stock Unit Agreement for Singapore Employees under the Second Amended and Restated 2007 Stock Option and Incentive Plan
|
|
|
10.27(31)
|
Form of Time Vesting Restricted Stock Unit Agreement for Non-Employee Directors under the Second Amended and Restated 2007 Stock Option and Incentive Plan
|
|
|
10.28(31)
|
Form of Incentive Stock Option Agreement for Section 16 Officers under the Second Amended and Restated 2007 Stock Option and Incentive Plan
|
|
|
10.29(31)
|
Form of Non-Qualified Stock Option Agreement for Section 16 Officers under the Second Amended and Restated 2007 Stock Option and Incentive Plan
|
|
|
10.30(31)
|
Form of Time Vesting Restricted Stock Unit Agreement for Employees at the Vice President Level and Above under the Second Amended and Restated 2007 Stock Option and Incentive Plan
|
|
|
10.31(31)
|
Form of Time Vesting Restricted Stock Unit Agreement for Section 16 Officers under the Second Amended and Restated 2007 Stock Option and Incentive Plan
|
|
|
10.32(26)
|
Convertible Notes Underwriting Agreement dated June 4, 2014 between Insulet Corporation and J.P. Morgan Securities LLC, as underwriter.
|
|
|
10.33(28)
|
Third Addendum to Manufacturing Services Agreement between Insulet Corporation and Flextronics Marketing (L) Ltd., dated May 29, 2014
|
|
|
10.34(28)
|
Four Addendum to Manufacturing Services Agreement between Insulet Corporation and Flextronics Marketing (L) Ltd., dated July 15, 2014
|
|
|
10.35(28)
|
Fifth Addendum to Manufacturing Services Agreement between Insulet Corporation and Flextronics Marketing (L) Ltd., dated July 15, 2014
|
|
|
10.36(29)
|
Retirement Agreement by and between Insulet Corporation and Duane DeSisto dated September 16, 2014
|
|
|
10.37(29)
|
Employment Agreement by and between Insulet Corporation and Patrick J. Sullivan dated September 16, 2014
|
|
|
10.38(30)
|
Agreement by and between Insulet Corporation and Brian K. Roberts dated November 5, 2014
|
|
|
10.39(31)
|
Form of Non-Qualified Stock Option Agreement for Patrick J. Sullivan under the Second Amended and Restated 2007 Stock Option and Incentive Plan
|
|
|
10.40(31)
|
Form of Incentive Stock Option Agreement for Christopher Barber under the Second Amended and Restated 2007 Stock Option and Incentive Plan
|
|
|
10.41(31)
|
Form of Time Vesting Restricted Stock Unit Agreement for Christopher Barber under the Second Amended and Restated 2007 Stock Option and Incentive Plan
|
|
|
10.42(31)
|
Form of Incentive Stock Option Agreement under the Second Amended and Restated 2007 Stock Option and Incentive Plan - October 2014 New Hires
|
|
|
10.43(33)
|
Rules and Conditions for the Directors' Compensation Program
|
|
|
10.44(33)
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Form of UK Time Vesting Restricted Stock Unit Agreement for Employees at the Vice President Level and Above under the Second Amended and Restated 2007 Stock Option and Incentive Plan
|
|
|
10.45(33)
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Form of Incentive Stock Option Agreement under the Second Amended and Restated 2007 Stock Option and Incentive Plan - 2015 Sales Plan
|
|
|
10.46(33)
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Form of Non-Qualified Stock Option Agreement for Brad Thomas under the Second Amended and Restated 2007 Stock Option and Incentive Plan
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|
|
|
|
Number
|
Description
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|
|
101
|
The following materials from Insulet Corporation’s Annual Report on Form 10-K for the year ended December 31, 2015 formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets; (ii) the Consolidated Statements of Operations; (iii) the Consolidated Statements of Comprehensive Loss; (iv) the Consolidated Statements of Changes in Stockholders’ Equity; (v) the Consolidated Statements of Cash Flows
|
*
|
This certification shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that Section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
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|
|
+
|
Confidential treatment granted as to certain portions of this exhibit.
|
(1)
|
Incorporated by reference to Amendment No. 2 to our Registration Statement on Form S-1 (File No. 333-140694) filed April 25, 2007
|
(2)
|
Incorporated by reference to Amendment No. 3 to our Registration Statement on Form S-1 (File No. 333-140694) filed May 8, 2007
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(3)
|
Incorporated by reference to our Registration Statement on Form S-1 (File No. 333-140694) filed February 14, 2007
|
(4)
|
Incorporated by reference to our Registration Statement on Form S-8 (No. 333-144636) filed July 17, 2007
|
(5)
|
Incorporated by reference to our Registration Statement on Form S-1 (File No. 333-146810) filed October 19, 2007
|
(6)
|
Incorporated by reference to our Current Report on Form 8-K, filed March 5, 2008
|
(7)
|
Incorporated by reference to our Current Report on Form 8-K, filed June 20, 2008
|
(8)
|
Incorporated by reference to our Definitive Proxy Statement on Form DEF14A, filed April 2, 2012
|
(9)
|
Incorporated by reference to our Form 8-A, filed November 20, 2008
|
(10)
|
Incorporated by reference to our Current Report on Form 8-K, filed March 16, 2009
|
(11)
|
Incorporated by reference to our Current Report on Form 8-A/A, filed September 28, 2009
|
(12)
|
Incorporated by reference to our Current Report on Form 8-K, filed March 5, 2009
|
(13)
|
Incorporated by reference to our Current Report on Form 8-K, filed September 28, 2009
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(14)
|
Incorporated by reference to our Annual Report on Form 10-K, filed March 9, 2010
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(15)
|
Incorporated by reference to our Current Report on Form 8-K, filed June 21, 2010
|
(16)
|
Incorporated by reference to our Quarterly Report on Form 10-Q/A, filed November 19, 2010
|
(17)
|
Incorporated by reference to our Quarterly Report on Form 10-Q/A, filed November 19, 2010
|
(18)
|
Incorporated by reference to our Current Report on Form 8-K, filed June 7, 2011
|
(19)
|
Incorporated by reference to our Current Report on Form 8-K, filed July 5, 2011
|
(20)
|
Incorporated by reference to our Annual Report on Form 10-K, filed March 10, 2011
|
(21)
|
Incorporated by reference to our Current Report on Form 8-K, filed January 10, 2011
|
(22)
|
Incorporated by reference to our Quarterly Report on Form 10-Q, filed May 9, 2012
|
(23)
|
Incorporated by reference to our Quarterly Report on Form 10-Q, filed August 8, 2012
|
(24)
|
Incorporated by reference to our Quarterly Report on Form 10-Q, filed November 7, 2013
|
(25)
|
Incorporated by reference to our Registration Statement on Form S-3, filed June 22, 2011
|
(26)
|
Incorporated by reference to our Current Report on Form 8-K, filed June 6, 2014
|
(27)
|
Incorporated by reference to our Current Report on Form 8-K, filed June 12, 2014
|
(28)
|
Incorporated by reference to our Quarterly Report on Form 10-Q, filed August 7, 2014
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(29)
|
Incorporated by reference to our Current Report on Form 8-K, filed September 16, 2014
|
(30)
|
Incorporated by reference to our Current Report on Form 8-K, filed November 5, 2014
|
(31)
|
Incorporated by reference to our Quarterly Report on Form 10-Q, filed November 5, 2014
|
(32)
|
Incorporated by reference to our Annual Report on Form 10-K, filed February 28, 2014
|
(33)
|
Incorporated by reference to our Annual Report on Form 10-K, filed February 26, 2015
|
(34)
|
Incorporated by reference to our Current Report on Form 8-K, filed April 1, 2015
|
(35)
|
Incorporated by reference to our Definitive Proxy Statement on Form DEF14A, filed April 2, 2015
|
(36)
|
Incorporated by reference to our Current Report on Form 8-K, filed June 30, 2015
|
(37)
|
Incorporated by reference to our Quarterly Report on Form 10-Q, filed August 12, 2015
|
(38)
|
Incorporated by reference to our Current Report on Form 8-K, filed January 7, 2015
|
(39)
|
Incorporated by reference to our Registration Statement on Form S-8 (No. 333-208387) filed December 8, 2015
|
(40)
|
Incorporated by reference to our Current Report on Forn 8-K, filed February 26, 2016
|
|
|
INSULET COPRORATION
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|
|
|
|
|
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|
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By: Patrick J. Sullivan
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|
|
Title: Chief Executive Officer
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|
|
|
|
|
|
|
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Grantee Name:
|
|
|
Grantee Acceptance Date:
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|
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|
|
|
INSULET COPRORATION
|
|
|
|
|
|
|
|
|
By: Patrick J. Sullivan
|
|
|
Title: Chief Executive Officer
|
|
|
|
|
|
|
|
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Optionee Name:
|
|
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Optionee Acceptance Date:
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|
|
|
|
|
INSULET COPRORATION
|
|
|
|
|
|
|
|
|
By: Patrick J. Sullivan
|
|
|
Title: Chief Executive Officer
|
|
|
|
|
|
|
|
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Grantee Name:
|
|
|
Grantee Acceptance Date:
|
|
|
|
|
|
INSULET COPRORATION
|
|
|
|
|
|
|
|
|
By: Patrick J. Sullivan
|
|
|
Title: Chief Executive Officer
|
|
|
|
|
|
|
|
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Optionee Name:
|
|
|
Optionee Acceptance Date:
|
|
|
|
|
|
INSULET COPRORATION
|
|
|
|
|
|
|
|
|
By: Patrick J. Sullivan
|
|
|
Title: Chief Executive Officer
|
|
|
|
|
|
|
|
|
Grantee Name:
|
|
|
Grantee Acceptance Date:
|
|
|
|
|
|
INSULET COPRORATION
|
|
|
|
|
|
|
|
|
By: Patrick J. Sullivan
|
|
|
Title: Chief Executive Officer
|
|
|
|
|
|
|
|
|
Optionee Name:
|
|
|
Optionee Acceptance Date:
|
|
|
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|
|
Name of Entity
|
|
State/Country of Organization
|
Sub-Q Solutions, Inc.
|
|
Delaware
|
Insulet MA Securities Corporation
|
|
Massachusetts
|
Insulet Singapore Private Limited
|
|
Singapore
|
Insulet Canada Corporation
|
|
Canada
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
|
/s/ Patrick J. Sullivan
|
|
Patrick J. Sullivan
|
|
President and Chief Executive Officer
|
|
|
|
Date: February 29, 2016
|
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
|
|
/s/ Michael L. Levitz
|
|
Michael L. Levitz
|
|
Chief Financial Officer
|
|
|
|
Date: February 29, 2016
|
|
|
|
/s/ Patrick J. Sullivan
|
|
Patrick J. Sullivan
|
|
President and Chief Executive Officer
|
|
|
|
Date: February 29, 2016
|
|
|
|
/s/ Michael L. Levitz
|
|
Michael L. Levitz
|
|
Chief Financial Officer
|
|
|
|
Date: February 29, 2016
|
|