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x
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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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68-0328265
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(State or other jurisdiction of
incorporation or organization)
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(IRS Employer
Identification No.)
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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
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The NASDAQ Stock Market, LLC
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Large accelerated filer
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Accelerated filer
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x
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Non-accelerated filer
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o
(Do not check if a smaller reporting company)
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Smaller reporting company
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o
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Item
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Description
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Page
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PART I
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1.
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1A.
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1B.
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2.
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3.
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4.
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PART II
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5.
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6.
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7.
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7A.
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8.
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9.
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9A.
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9B.
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PART III
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10.
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11.
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12.
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13.
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14.
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PART IV
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15.
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16.
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Item 1.
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Business
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•
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Traditional minimally-invasive endovascular aneurysm repair (“EVAR”) or
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Endovascular aneurysm sealing (“EVAS”), our innovative solution for sealing the aneurysm sac while maintaining blood flow through two blood flow lumens.
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Focus exclusively on the aorta for the commercialization of innovative products.
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Design and manufacture EVAR and EVAS products that are easy to use and deliver excellent clinical outcomes.
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Design EVAR and EVAS products to expand into the treatment of complex AAA and thoracic anatomies.
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Offer physicians and hospitals a broad range of products so they can provide the best device for each individual patient.
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Provide exceptional clinical and technical support to physicians through an experienced and knowledgeable sales and clinical organization.
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Market Description ($ in millions)
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Penetrated
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Unpenetrated
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Total
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||||||
Traditional
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$
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1,337
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$
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306
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$
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1,643
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Complex
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373
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803
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1,176
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Thoracic
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589
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606
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1,195
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Total
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$
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2,299
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$
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1,715
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$
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4,014
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•
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Anatomical Fixation
. The AFX System is unique in that the main body of the device sits on the patient's natural aortoiliac bifurcation. This provides a solid foundation for the long-term stability of the device. Alternative EVAR devices rely on hooks, barbs and radial force to anchor within the aorta (commonly referred to as "proximal fixation") near the renal arteries. The data from our clinical studies have demonstrated anatomical fixation can inhibit device migration within the aorta due to the inherent foundational support of the patient’s own anatomy.
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Minimally Invasive Delivery System
. The AFX System requires 17F introducer access on the ipsilateral side and 7F introducer access on the contralateral side. Comparative endovascular stent grafts for infrarenal repair require between 12F and 22F introducer access on the ipsilateral side and between 10F and 16F introducer access on the contralateral side.
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Preserves Aortic Bifurcation.
The AFX System allows for future endovascular procedures when access across the aortic bifurcation is required. Approximately 30% to 40% of AAA patients also have peripheral arterial disease (“PAD”). The AFX System is the only graft presently available that preserves the physician's ability to go back over the aortic bifurcation for future interventions. This is a meaningful feature of the AFX System, as many AAA patients today are living longer and returning to the hospital for PAD procedures.
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Patient Accessibility.
Our FDA and CE Mark-approved Instructions for Use (“IFU”) allow for the on-label treatment of more patients who otherwise may undergo an off-label EVAR procedure or be subject to open surgical repair, or not receive treatment at all. Our differentiated platform expands the pool of patients eligible for EVAR by virtue of its low profile and flexible delivery system that addresses several key anatomical access challenges, while providing a novel sealing mechanism to address many of the difficulties of diseased patient anatomies.
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Ability to Pass through Small Access Vessels.
The Ovation System’s novel separation and optimization of fixation and seal minimize the overlap between metal and fabric within the catheter, allowing the device to be loaded in a delivery catheter that is smaller than those of conventional EVAR devices. At an outer diameter of 14F, or approximately 4.7mm, the Ovation System is the lowest profile FDA-approved stent graft.
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Ability to Pass through Diseased and/or Tortuous Access Vessels.
The Ovation System has the lowest profile FDA-approved delivery system. Its characteristics increase flexibility, designed to enable easier passage through access vessels.
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The Ovation System Enables Minimally Invasive Techniques.
The Ovation System’s low profile and proven safety record offer physicians the opportunity to provide percutaneous endovascular aneurysm repair access (“PEVAR”) with regional or local anesthesia to more patients. Studies have shown that the use of smaller profile delivery devices results in fewer access site complications.
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Treatment of Complex Anatomy.
The separation and optimization of the fixation and sealing mechanisms of the Ovation System enable the device to seal with a smaller aortic contact area than conventional EVAR devices.
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Avoiding Aortic Neck Dilatation
. The Ovation System’s polymer filled sealing rings do not exert significant chronic, outward pressure at the` neck of the aorta. In the Ovation Pivotal Trial, core lab results demonstrated stable neck diameter and durable seal with the Ovation System through five-year follow-up.
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Potentially Reduce Endoleaks Leading to Secondary Interventions.
The Nellix EVAS System seals the entire aneurysm, potentially reducing the likelihood of many causes of secondary intervention in EVAR procedures.
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Low Profile Introducer.
The delivery catheter for the Nellix EVAS System has an outer diameter of 17F, which is beneficial for the delivery of the devices in tight access arteries, potentially reducing risk of vascular injuries to the patient.
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IntuiTrak
. We received FDA approval for IntuiTrak in October 2008, CE Mark approval for IntuiTrak in March 2010, and Japanese Shonin approval for IntuiTrak in December 2012. IntuiTrak provided an updated delivery system that enhanced physician ease of use and for manufacturability.
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AFX.
In May 2011 and November 2011, we received FDA approval and CE Mark approval, respectively, for the AFX System, and we received Japanese Shonin approval for the AFX System in December 2015. We began a full commercial launch of the AFX System in the United States in August 2011 and in numerous international markets in 2012. In addition, we entered into a distribution arrangement with a Japanese distributor to introduce the AFX System in the Japanese market in the first quarter of 2016.
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AFX2.
In October 2015, we received FDA approval for our AFX2 Bifurcated Endograft System (“AFX2”).
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Ovation TriVascular.
We received CE mark approval for the Ovation System in August 2010 and FDA approval for the Ovation System in October 2012. In February 2015, the FDA approved our next generation Ovation iX Iliac Stent Graft for the Ovation System, and in July 2015, the FDA approved the Ovation
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Nellix EVAS System
. In February 2013, we received CE Mark approval of the Nellix EVAS System, and we commenced a limited market introduction of the Nellix EVAS System in Europe. In December 2013, we received IDE approval in the United States to begin a clinical trial which commenced in January 2014. Enrollment in the IDE study was completed in November 2014. In the fourth quarter of 2014, we obtained IDE continued access approval for additional patients. In April 2016, we announced achievement of CE Mark approval of the next-generation Nellix EVAS System. In September 2017, we announced CE Mark approval for the Nellix EVAS System with the refined IFU. In October 2017, we received IDE approval in the United States to begin the EVAS2 confirmatory clinical study to evaluate the next-generation Nellix EVAS System.
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ChEVAS
. ChEVAS is a procedure where the Nellix EVAS System could potentially be used together with branch stent grafts to treat patients with complex aortic anatomies. Physicians initiated a clinical trial called ASCEND (Aneurysm Study for Complex AAA: Evaluation of Nellix Durability) to evaluate the clinical performance of ChEVAS. We are pursuing CE mark and FDA approval for this indication.
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EVAS FORWARD IDE
- We conducted this pivotal clinical trial to evaluate the safety and effectiveness of the Nellix EVAS System. This study is a prospective single arm registry which enrolled 179 patients at 29 centers in the United States and Europe. In November 2014, we completed enrollment in the study, and we submitted the one year results to the FDA in March 2016. In May 2016, we announced the results of the one year clinical data from the EVAS FORWARD IDE study that demonstrate that the Nellix EVAS System met the study primary endpoints for major adverse events at 30 days (safety) and treatment success at one year (effectiveness). Two-year imaging revealed a signal of migration, leading to a field safety notification issued in October 2016 and a dedicated root cause analysis, resulting in refinements to the IFU. Following the implementation of the refined IFU, the Nellix EVAS system is applicable to treat an estimated 40% of AAA patients with a traditional aneurysm.
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Freedom from all endoleaks (94%), rupture (97%), all-cause mortality (97%), and cardiovascular mortality (99%), among all patients.
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Highest freedom of type II endoleaks, of 97%, ever reported at two years, among all patients.
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When applying the refined IFUs for Nellix, patients at the two-year follow-up demonstrated 96% freedom from Type IA endoleak, migration >10mm, and sac growth.
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EVAS2 IDE
- In May 2017, we announced the decision to seek United States approval of the Nellix EVAS System by conducting a confirmatory clinical study with the updated IFU and the Gen2 device design. The Gen2 device incorporates design improvements to enhance ease of use and offers physicians more sizes to treat more patients with AAA. In October 2017, we announced our receipt of IDE approval from the FDA to commence a confirmatory clinical study to evaluate the safety and effectiveness of the Gen2 Nellix EVAS System for the
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EVAS FORWARD Global Registry
- This study is designed to provide real world clinical results to demonstrate the effectiveness and applicability of the Nellix EVAS System. The first phase of the registry included 300 patients enrolled in up to 30 international centers. The first patient in the registry was treated in October 2013. In September 2014, we announced completion of patient enrollment in the EVAS FORWARD Global Registry. In November 2016, we announced positive two-year results on 300 patients from the EVAS FORWARD Global Registry at the annual VEITH meeting. The following outcomes were presented at the annual VEITH meeting:
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37% of the patients had complex anatomies;
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98% freedom from any persistent endoleaks at latest follow-up;
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No secondary interventions for Type II endoleaks;
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97% freedom from aneurysm-related mortality; and
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99% freedom from cardiovascular mortality.
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ASCEND Registry
- In April 2016, we announced the first data presentation with one-year outcomes from the
ASCEND
Registry (Aneurysm Study for Complex AAA: Evaluation of Nellix Durability), a physician-initiated registry of the Nellix EVAS System used with aortic branch stent grafts for the treatment of patients with complex AAAs. The results of the study were formally published in the peer-reviewed Journal of Endovascular Therapy in December 2017.
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99% freedom from aneurysm-related mortality;
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99% freedom from migration, rupture, and conversion;
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97% freedom from Type I/III endoleak; and
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Excellent freedom from secondary intervention for occlusion (97%), Type I endoleak (97%) and Type II endoleak 95%.
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Low major adverse event rate of 0.4%;
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No ruptures, conversion, or secondary interventions;
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99% and 100% freedom from type I and type III endoleaks, respectively;
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Fast-Track completed in 216 (87%) patients, with positive results compared to non-Fast-Track patients;
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Procedure time of 84 minutes vs. 110 minutes;
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General anesthesia use 0% vs. 18%;
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ICU stay 0% vs. 32%; and
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Mean hospital stay 1.2 vs. 1.9 days.
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At least 28% greater EVAR eligibility for women with AAA;
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1.3% major adverse events, the lowest rate reported for EVAR, compared to other contemporary, prospective, post-market registries;
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No deaths;
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No proximal endoleaks;
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No limb occlusion;
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Low readmission rate of 3.9%; and
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100% procedural success
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Broad patient applicability, with 40% of the patients treated outside the labeled indications of other EVAR devices;
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Stable aortic neck diameters with an average expansion of 0.1%, compared to 25% as reported with other EVAR devices;
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97% freedom from secondary interventions related to type I endoleak; and
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No migration or conversions.
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clinical effectiveness;
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product safety, reliability, and durability;
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ease of use;
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sales force experience and relationships; and
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price.
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ICD-10 PCS
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Description
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Abdominal Aorta
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04V03DZ
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Restriction of Abdominal Aorta, with Intraluminal Device, Percutaneous Approach
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04V04DZ
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Restriction of Abdominal Aorta, with Intraluminal Device, Percutaneous Endoscopic Approach
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04V03DJ
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Restriction of Abdominal Aorta, with Intraluminal Device, Temporary, Percutaneous Approach
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04V04DJ
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Restriction of Abdominal Aorta, with Intraluminal Device, Temporary, Percutaneous Endoscopic Approach
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04U03JZ
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Supplement of Abdominal Aorta with Synthetic Substitute, Percutaneous Approach
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04U04JZ
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Supplement of Abdominal Aorta with Synthetic Substitute, Percutaneous Endoscopic Approach
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Aortic and Heart Assist Procedures Except Pulsation Balloon with MCC
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$37,598
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Aortic and Heart Assist Procedures Except Pulsation Balloon without MCC
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$24,017
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Foreign medical reimbursement policies and programs;
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Complex data privacy requirements and laws;
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Ever-changing and contradictory country-specific guidelines, transparency requirements and laws;
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The Foreign Corrupt Practices Act, a United States law, which prosecutes United States companies who engage in bribery when doing business with physicians, distributors, agents, and other third parties outside the United States Many physicians outside the United States are considered government officials, and United States companies, together with individuals who engaged in the bribery, face civil and criminal sanctions both in the United States and any country where bribery of a government official violates the law of that country;
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Foreign anti-corruption laws, such as the UK Bribery Act; and
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•
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Trade protection measures, including import or export restrictions or sanctions, that may restrict us from doing business in and/or shipping products to certain parts of the world.
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Item 1A.
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Risk Factors
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greater financial and human resources for product development, sales and marketing and patent litigation;
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greater name recognition;
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long established relationships with physicians, customers, and third-party payors;
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additional lines of products, and the ability to offer rebates or bundle products to offer greater discounts or incentives;
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more established sales and marketing programs, and distribution networks;
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greater experience in conducting research and development, manufacturing, clinical trials, preparing regulatory submissions, and obtaining regulatory clearance or approval for products and marketing approved products; and
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greater buying power and influence with suppliers.
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difficulties in enforcing or defending intellectual property rights;
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pricing pressure that we may experience internationally;
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a shortage of high-quality sales people and distributors;
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changes in third-party reimbursement policies that may require some of the patients who receive our products to directly absorb medical costs or that may necessitate the reduction of the selling prices of our products;
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the imposition of additional United States and foreign governmental controls or regulations;
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economic instability;
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changes in duties and tariffs, license obligations and other non-tariff barriers to trade;
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the imposition of restrictions on the activities of foreign agents, representatives and distributors;
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scrutiny of foreign tax authorities which could result in significant fines, penalties and additional taxes being imposed on us;
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laws and business practices favoring local companies;
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longer payment cycles;
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difficulties in maintaining consistency with our internal guidelines;
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difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;
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the imposition of costly and lengthy new export licensing requirements;
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the imposition of United States or international sanctions against a country, company, person or entity with whom we do business that would restrict or prohibit continued business with the sanctioned country, company, person or entity; and
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the imposition of new trade restrictions.
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the FDA, institutional review boards or other regulatory authorities do not approve a clinical study protocol, force us to modify a previously approved protocol, or place a clinical study on hold;
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patients do not enroll in, or enroll at the expected rate, or complete a clinical study;
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patients or investigators do not comply with study protocols;
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patients do not return for post-treatment follow-up at the expected rate;
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patients experience serious or unexpected adverse side effects for a variety of reasons that may or may not be related to our products such as the advanced stage of co-morbidities that may exist at the time of treatment, causing a clinical study to be put on hold or terminated.
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sites participating in an ongoing clinical study may withdraw, requiring us to engage new sites;
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difficulties or delays associated with establishing additional clinical sites;
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third-party clinical investigators decline to participate in our clinical studies, do not perform the clinical studies on the anticipated schedule, or are inconsistent with the investigator agreement, clinical study protocol, good clinical practices, and other FDA and Institutional Review Board requirements;
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Failure to complete data collection analysis in a timely or accurate manner;
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regulatory inspections of our clinical studies require us to undertake corrective action or suspend or terminate our clinical studies;
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changes in federal, state, or foreign governmental statutes, regulations or policies;
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interim results are inconclusive or unfavorable as to immediate and long-term safety or efficacy;
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the study design is inadequate to demonstrate safety and efficacy; or
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the results of the study do not meet the study endpoints.
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failure of our suppliers to comply with regulatory requirements;
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any strike or work stoppage;
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disruptions in shipping;
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a natural disaster caused by fire, flood or earthquakes; or
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a supply shortage experienced by a single source supplier.
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stop selling, making, or using products that use the disputed intellectual property;
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obtain a license from the intellectual property owner to continue selling, making, licensing, or using products, which license may not be available on reasonable terms, or at all;
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redesign our products, processes or services; or
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subject us to significant liabilities to third parties.
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decreased demand for our products;
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injury to our reputation;
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injury to our relationships with our customers;
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significant litigation and other costs;
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substantial monetary awards to or costly settlements with patients;
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product recalls;
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loss of revenue; and
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the inability to commercialize new products.
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the possibility that we will pay more than the value we derive from the acquisition, which could result in future non-cash impairment charges;
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difficulties in integration of the operations, technologies, and products of the acquired companies, which may require significant attention of our management that otherwise would be available for the ongoing development of our business;
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the assumption of certain known and unknown liabilities of the acquired companies; and
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difficulties in retaining key relationships with employees, customers, partners, and suppliers of the acquired company.
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•
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the results of our commercialization efforts for our existing and future products;
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the revenues generated by sales of our existing and future products;
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the need for additional capital to fund existing and future development programs;
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the need to adapt to changing technologies and technical requirements, and the costs related thereto;
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the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property;
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the establishment of high volume manufacturing and increased sales and marketing capabilities; and
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whether we are successful if we enter into collaborative relationships with other parties.
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properly identify and anticipate physicians and patient needs;
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develop and introduce new products or product enhancements in a timely manner;
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avoid infringing upon the intellectual property rights of third parties;
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demonstrate, if required, the safety and efficacy of new products with data from preclinical studies and clinical trials;
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obtain the necessary regulatory clearances or approvals for new products or product enhancements;
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be fully FDA-compliant with marketing of new devices or modified products;
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provide adequate training to potential users of our products;
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receive adequate coverage and reimbursement for procedures performed with our products; and
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•
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develop an effective and FDA-compliant, dedicated marketing and distribution network.
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•
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FDA Regulations (Title 21 CFR);
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•
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European Union CE mark requirements, including the new Medical Device Regulations and MEDDEV 2.7.1 Rev.4, which implement stricter requirements for clinical data to support new product approvals;
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•
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Other international regulatory approval requirements;
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•
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Medical Device Single Audit Program (“MDSAP”);
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•
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Medical Device Quality Management System Requirements (21 CFR 820, ISO 13485:2003, EN ISO 13485:2012, ISO 13485:2016, and other similar international regulations);
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•
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Occupational Safety and Health Administration requirements; and
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•
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California Department of Health Services requirements.
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•
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physician acceptance of our products;
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•
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the conduct and results of clinical trials;
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•
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the timing and expense of obtaining future regulatory approvals;
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•
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fluctuations in our expenses associated with expanding our operations;
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•
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the introduction of new products by our competitors;
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•
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the timing of product launch may lead to excess or obsolete inventory;
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•
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supplier, manufacturing or quality problems with our devices;
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•
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litigation expenses;
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•
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the timing of stocking orders from our distributors;
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•
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changes in our pricing policies or in the pricing policies of our competitors or suppliers; and
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•
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changes in third-party payors’ reimbursement policies.
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•
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announcements by us or our competitors concerning technological innovations;
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•
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introductions of new products;
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•
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FDA and foreign regulatory actions;
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•
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developments or disputes relating to patents or proprietary rights;
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•
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maintain the effectiveness of our Quality System;
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•
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failure of our results of operations to meet the expectations of stock market analysts and investors;
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•
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changes in stock market analyst recommendations regarding our common stock;
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•
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the conversion of some or all of our senior convertible notes and any sales in the public market of shares of our common stock issued upon conversion of such notes;
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•
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changes in healthcare policy in the United States or other countries; and
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•
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general stock market and economic conditions and other factors unrelated to our operating performance.
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Item 1B.
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Unresolved Staff Comments
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Item 2.
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Properties
|
Item 5.
|
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
|
|
High
|
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Low
|
||||
Year Ended December 31, 2016
|
|
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|
||||
First Quarter
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$
|
10.04
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|
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$
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6.51
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Second Quarter
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13.60
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8.13
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Third Quarter
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14.50
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11.33
|
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Fourth Quarter
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13.25
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|
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4.78
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Year Ended December 31, 2017
|
|
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|
||||
First Quarter
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$
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7.44
|
|
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$
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5.45
|
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Second Quarter
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7.66
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4.21
|
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Third Quarter
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5.37
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|
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4.08
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|
||
Fourth Quarter
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6.50
|
|
|
4.50
|
|
Item 6.
|
Selected Financial Data
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
|
(In thousands, except per share data)
|
|
|
||||||||||||||||
Consolidated Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenue
|
$
|
181,157
|
|
|
$
|
192,925
|
|
|
$
|
153,612
|
|
|
$
|
147,588
|
|
|
$
|
132,257
|
|
Cost of goods sold
|
59,828
|
|
|
69,133
|
|
|
51,821
|
|
|
41,801
|
|
|
32,750
|
|
|||||
Gross profit
|
121,329
|
|
|
123,792
|
|
|
101,791
|
|
|
105,787
|
|
|
99,507
|
|
|||||
Operating expenses:
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|
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|
||||||||||
Research and development
|
21,019
|
|
|
32,337
|
|
|
26,421
|
|
|
21,616
|
|
|
16,199
|
|
|||||
Clinical and regulatory affairs
|
12,952
|
|
|
16,215
|
|
|
15,418
|
|
|
13,243
|
|
|
8,679
|
|
|||||
Marketing and sales
|
92,400
|
|
|
107,759
|
|
|
78,213
|
|
|
73,411
|
|
|
63,588
|
|
|||||
General and administrative
|
35,301
|
|
|
41,044
|
|
|
29,581
|
|
|
26,663
|
|
|
21,409
|
|
|||||
Restructuring cost
|
1,477
|
|
|
11,093
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Contract termination and business acquisition expenses
|
—
|
|
|
5,768
|
|
|
5,071
|
|
|
—
|
|
|
—
|
|
|||||
Settlement costs
|
—
|
|
|
4,650
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total operating expenses
|
163,149
|
|
|
218,866
|
|
|
154,704
|
|
|
134,933
|
|
|
109,875
|
|
|||||
Loss from operations
|
(41,820
|
)
|
|
(95,074
|
)
|
|
(52,913
|
)
|
|
(29,146
|
)
|
|
(10,368
|
)
|
|||||
Total other income (expense)
|
(25,039
|
)
|
|
(59,105
|
)
|
|
(6,848
|
)
|
|
(3,334
|
)
|
|
(5,710
|
)
|
|||||
Net loss before income tax benefit (expense)
|
(66,859
|
)
|
|
(154,179
|
)
|
|
(59,761
|
)
|
|
(32,480
|
)
|
|
(16,078
|
)
|
|||||
Income tax benefit (expense)
|
459
|
|
|
(498
|
)
|
|
9,337
|
|
|
62
|
|
|
10
|
|
|||||
Net loss
|
$
|
(66,400
|
)
|
|
$
|
(154,677
|
)
|
|
$
|
(50,424
|
)
|
|
$
|
(32,418
|
)
|
|
$
|
(16,068
|
)
|
Basic and diluted net loss per share
|
$
|
(0.80
|
)
|
|
$
|
(1.91
|
)
|
|
$
|
(0.75
|
)
|
|
$
|
(0.50
|
)
|
|
$
|
(0.26
|
)
|
Shares used in computing basic and diluted loss per share
|
83,325
|
|
|
80,976
|
|
|
67,671
|
|
|
65,225
|
|
|
62,607
|
|
|||||
|
|
||||||||||||||||||
|
December 31,
|
||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
Consolidated Balance Sheet Data:
|
(In thousands)
|
||||||||||||||||||
Cash and cash equivalents and marketable securities
|
$
|
57,991
|
|
|
$
|
47,108
|
|
|
$
|
177,321
|
|
|
$
|
86,669
|
|
|
$
|
126,465
|
|
Accounts receivable, net
|
$
|
32,294
|
|
|
$
|
34,430
|
|
|
$
|
28,531
|
|
|
$
|
26,113
|
|
|
$
|
24,972
|
|
Total assets
|
$
|
365,047
|
|
|
$
|
359,684
|
|
|
$
|
331,050
|
|
|
$
|
248,209
|
|
|
$
|
256,197
|
|
Debt
|
$
|
208,253
|
|
|
$
|
177,178
|
|
|
$
|
167,748
|
|
|
$
|
70,407
|
|
|
$
|
67,101
|
|
Total liabilities
|
$
|
289,985
|
|
|
$
|
246,891
|
|
|
$
|
227,743
|
|
|
$
|
124,059
|
|
|
$
|
151,556
|
|
Accumulated deficit
|
$
|
520,001
|
|
|
$
|
453,601
|
|
|
$
|
298,924
|
|
|
$
|
248,500
|
|
|
$
|
216,082
|
|
Total stockholders’ equity
|
$
|
75,062
|
|
|
$
|
112,793
|
|
|
$
|
103,307
|
|
|
$
|
124,150
|
|
|
$
|
104,641
|
|
Item 7.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
•
|
We have appropriate evidence of a binding arrangement with our customer;
|
•
|
The sales price for our product (including extensions and accessories) is established with our customer;
|
|
Year Ended December 31,
|
||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||||||||
Revenue
|
$
|
181,157
|
|
|
100.0%
|
|
$
|
192,925
|
|
|
100.0%
|
|
$
|
153,612
|
|
|
100.0%
|
Cost of goods sold
|
59,828
|
|
|
33.0%
|
|
69,133
|
|
|
35.8%
|
|
51,821
|
|
|
33.7%
|
|||
Gross profit
|
121,329
|
|
|
67.0%
|
|
123,792
|
|
|
64.2%
|
|
101,791
|
|
|
66.3%
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Research and development
|
21,019
|
|
|
11.6%
|
|
32,337
|
|
|
16.8%
|
|
26,421
|
|
|
17.2%
|
|||
Clinical and regulatory affairs
|
12,952
|
|
|
7.1%
|
|
16,215
|
|
|
8.4%
|
|
15,418
|
|
|
10.0%
|
|||
Marketing and sales
|
92,400
|
|
|
51.0%
|
|
107,759
|
|
|
55.9%
|
|
78,213
|
|
|
50.9%
|
|||
General and administrative
|
35,301
|
|
|
19.5%
|
|
41,044
|
|
|
21.3%
|
|
29,581
|
|
|
19.3%
|
|||
Restructuring costs
|
1,477
|
|
|
0.8%
|
|
11,093
|
|
|
5.7%
|
|
—
|
|
|
—%
|
|||
Settlement costs
|
—
|
|
|
—%
|
|
4,650
|
|
|
2.4%
|
|
—
|
|
|
—%
|
|||
Contract termination and business acquisition expenses
|
—
|
|
|
—%
|
|
5,768
|
|
|
3.0%
|
|
5,071
|
|
|
3.3%
|
|||
Total operating expenses
|
163,149
|
|
|
90.1%
|
|
218,866
|
|
|
113.4%
|
|
154,704
|
|
|
100.7%
|
|||
Loss from operations
|
(41,820
|
)
|
|
(23.1)%
|
|
(95,074
|
)
|
|
(49.3)%
|
|
(52,913
|
)
|
|
(34.4)%
|
|||
Total other income (expense)
|
(25,039
|
)
|
|
(13.8)%
|
|
(59,105
|
)
|
|
(30.6)%
|
|
(6,848
|
)
|
|
(4.5)%
|
|||
Net loss before income tax benefit
|
(66,859
|
)
|
|
(36.9)%
|
|
(154,179
|
)
|
|
(79.9)%
|
|
(59,761
|
)
|
|
(38.9)%
|
|||
Income tax benefit (expense)
|
459
|
|
|
0.3%
|
|
(498
|
)
|
|
(0.3)%
|
|
9,337
|
|
|
6.1%
|
|||
Net loss
|
$
|
(66,400
|
)
|
|
(36.7)%
|
|
$
|
(154,677
|
)
|
|
(80.2)%
|
|
$
|
(50,424
|
)
|
|
(32.8)%
|
|
Year Ended December 31,
|
|
|
|
|
||||||||
|
2017
|
|
2016
|
|
Variance
|
|
Percent Change
|
||||||
|
(in thousands)
|
|
|
|
|
||||||||
Revenue
|
$
|
181,157
|
|
|
$
|
192,925
|
|
|
$
|
(11,768
|
)
|
|
(6.1)%
|
|
|
Year Ended December 31,
|
|
|
|
|
||||||||
|
|
2017
|
|
2016
|
|
Variance
|
|
Percent Change
|
||||||
|
|
(in thousands)
|
|
|
|
|
||||||||
Cost of goods sold
|
|
$
|
59,828
|
|
|
$
|
69,133
|
|
|
$
|
(9,305
|
)
|
|
(13.5)%
|
Gross profit
|
|
121,329
|
|
|
123,792
|
|
|
(2,463
|
)
|
|
(2.0)%
|
|||
Gross margin percentage (gross profit as a percent of revenue)
|
|
67.0
|
%
|
|
64.2
|
%
|
|
2.8
|
%
|
|
|
|
|
Year Ended December 31,
|
|
|
|
|
||||||||
|
|
2017
|
|
2016
|
|
Variance
|
|
Percent Change
|
||||||
|
|
(in thousands)
|
|
|
|
|
||||||||
Research and development
|
|
$
|
21,019
|
|
|
$
|
32,337
|
|
|
$
|
(11,318
|
)
|
|
(35.0)%
|
Clinical and regulatory affairs
|
|
12,952
|
|
|
16,215
|
|
|
(3,263
|
)
|
|
(20.1)%
|
|||
Marketing and sales
|
|
92,400
|
|
|
107,759
|
|
|
(15,359
|
)
|
|
(14.3)%
|
|||
General and administrative
|
|
35,301
|
|
|
41,044
|
|
|
(5,743
|
)
|
|
(14.0)%
|
|||
Restructuring costs
|
|
1,477
|
|
|
11,093
|
|
|
(9,616
|
)
|
|
(86.7)%
|
|||
Settlement costs
|
|
—
|
|
|
4,650
|
|
|
(4,650
|
)
|
|
(100.0)%
|
|||
Contract termination and business acquisition expenses
|
|
—
|
|
|
5,768
|
|
|
(5,768
|
)
|
|
(100.0)%
|
|
|
Year Ended December 31,
|
|
|
|
|
||||||||
|
|
2017
|
|
2016
|
|
Variance
|
|
Percent Change
|
||||||
|
|
(in thousands)
|
|
|
|
|
||||||||
Other income (expense), net
|
|
$
|
(25,039
|
)
|
|
$
|
(59,105
|
)
|
|
$
|
34,066
|
|
|
(57.6)%
|
|
|
Year Ended December 31,
|
|
|
|
|
||||||||
|
|
2017
|
|
2016
|
|
Variance
|
|
Percent Change
|
||||||
|
|
(in thousands)
|
|
|
|
|
||||||||
Income tax benefit (expense)
|
|
$
|
459
|
|
|
$
|
(498
|
)
|
|
$
|
957
|
|
|
>100%
|
|
|
Year Ended December 31,
|
|
|
|
|
||||||||
|
|
2016
|
|
2015
|
|
Variance
|
|
Percent Change
|
||||||
|
|
(in thousands)
|
|
|
|
|
||||||||
Revenue
|
|
$
|
192,925
|
|
|
$
|
153,612
|
|
|
$
|
39,313
|
|
|
25.6%
|
|
|
Year Ended December 31,
|
|
|
|
|
||||||||
|
|
2016
|
|
2015
|
|
Variance
|
|
Percent Change
|
||||||
|
|
(in thousands)
|
|
|
|
|
||||||||
Cost of goods sold
|
|
$
|
69,133
|
|
|
$
|
51,821
|
|
|
$
|
17,312
|
|
|
33.4%
|
Gross profit
|
|
123,792
|
|
|
101,791
|
|
|
22,001
|
|
|
21.6%
|
|||
Gross margin percentage (gross profit as a percent of revenue)
|
|
64.2
|
%
|
|
66.3
|
%
|
|
(2.1
|
)%
|
|
|
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
|
|
2016
|
|
2015
|
|
Variance
|
|
Percent Change
|
|||||||
|
|
(in thousands)
|
|
|
|
|
|||||||||
Research and development
|
|
$
|
32,337
|
|
|
$
|
26,421
|
|
|
$
|
5,916
|
|
|
22.4%
|
|
Clinical and regulatory affairs
|
|
16,215
|
|
|
15,418
|
|
|
797
|
|
|
5.2%
|
||||
Marketing and sales
|
|
107,759
|
|
|
78,213
|
|
|
29,546
|
|
|
37.8%
|
||||
General and administrative
|
|
41,044
|
|
|
29,581
|
|
|
11,463
|
|
|
38.8%
|
||||
Restructuring costs
|
1,477
|
|
11,093
|
|
|
—
|
|
|
11,093
|
|
|
100.0%
|
|||
Settlement costs
|
—
|
|
4,650
|
|
|
—
|
|
|
4,650
|
|
|
100.0%
|
|||
Contract termination and business acquisition expenses
|
|
5,768
|
|
|
5,071
|
|
|
697
|
|
|
13.7%
|
|
|
Year Ended December 31,
|
|
|
|
|
|||||||
|
|
2016
|
|
2015
|
|
Variance
|
|
Percent Change
|
|||||
|
|
(in thousands)
|
|
|
|
|
|||||||
Other income (expense), net
|
|
$
|
(59,105
|
)
|
|
$
|
(6,848
|
)
|
|
(52,257
|
)
|
|
>100%
|
|
|
Year Ended December 31,
|
|
|
|
|
||||||||
|
|
2016
|
|
2015
|
|
Variance
|
|
Percent Change
|
||||||
|
|
(in thousands)
|
|
|
|
|
||||||||
Income tax benefit (expense)
|
|
$
|
(498
|
)
|
|
$
|
9,337
|
|
|
$
|
(9,835
|
)
|
|
>100%
|
|
December 31, 2017
|
|
December 31, 2016
|
|
December 31, 2015
|
||||||
|
(in thousands, except financial metrics data)
|
||||||||||
Cash and cash equivalents
|
$
|
57,991
|
|
|
$
|
26,120
|
|
|
$
|
124,553
|
|
Marketable securities
|
$
|
—
|
|
|
$
|
20,988
|
|
|
$
|
52,768
|
|
Accounts receivable, net
|
$
|
32,294
|
|
|
$
|
34,430
|
|
|
$
|
28,531
|
|
Total current assets
|
$
|
143,134
|
|
|
$
|
129,845
|
|
|
$
|
236,412
|
|
Total current liabilities
|
$
|
60,630
|
|
|
$
|
44,902
|
|
|
$
|
50,855
|
|
Working capital surplus (a)
|
$
|
82,504
|
|
|
$
|
84,943
|
|
|
$
|
185,557
|
|
Current ratio (b)
|
2.4
|
|
|
2.9
|
|
|
4.6
|
|
|||
Days sales outstanding (“DSO”) (c)
|
68
|
|
|
67
|
|
|
67
|
|
|||
Inventory turnover (d)
|
1.4
|
|
|
2.0
|
|
|
1.8
|
|
•
|
the need for working capital to support our sales growth;
|
•
|
the need for additional capital to fund future development programs;
|
•
|
the need for additional capital to fund our sales force expansion;
|
•
|
the need for additional capital to fund strategic acquisitions;
|
•
|
our requirements for additional facility space or manufacturing capacity;
|
•
|
our requirements for additional information technology infrastructure and systems; and
|
•
|
adverse outcomes from potential litigation and the cost to defend such litigation.
|
|
Payments due by period
|
|
|
||||
Contractual Obligations
|
Total
|
2018
|
2019
|
2020
|
2021
|
2022
|
2023 and thereafter
|
Long-term debt obligations
|
$263,278
|
$18,278
|
$—
|
$125,000
|
$40,000
|
$40,000
|
$40,000
|
Interest on debt obligations
|
50,242
|
12,832
|
12,421
|
12,455
|
6,962
|
4,175
|
1,397
|
Operating lease obligations
|
36,265
|
3,450
|
3,567
|
3,735
|
3,692
|
3,800
|
18,021
|
Total
|
$349,785
|
$34,560
|
$15,988
|
$141,190
|
$50,654
|
$47,975
|
$59,418
|
Item
|
|
Page
|
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
|
|
December 31,
|
||||||
|
|
2017
|
|
2016
|
||||
ASSETS
|
|
|
|
|
||||
Current assets:
|
|
|
|
|
||||
Cash and cash equivalents
|
|
$
|
57,991
|
|
|
$
|
26,120
|
|
Restricted cash
|
|
2,608
|
|
|
2,001
|
|
||
Marketable securities
|
|
—
|
|
|
20,988
|
|
||
Accounts receivable, net of allowance for doubtful accounts of $470 and $1,037, respectively
|
|
32,294
|
|
|
34,430
|
|
||
Other receivables
|
|
418
|
|
|
1,787
|
|
||
Inventories
|
|
45,153
|
|
|
41,160
|
|
||
Prepaid expenses and other current assets
|
|
4,670
|
|
|
3,359
|
|
||
Total current assets
|
|
$
|
143,134
|
|
|
$
|
129,845
|
|
Property and equipment, net
|
|
19,212
|
|
|
23,265
|
|
||
Goodwill
|
|
120,927
|
|
|
120,711
|
|
||
Intangibles, net
|
|
80,403
|
|
|
84,511
|
|
||
Deposits and other assets
|
|
1,371
|
|
|
1,352
|
|
||
Total assets
|
|
$
|
365,047
|
|
|
$
|
359,684
|
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
||||
Current liabilities:
|
|
|
|
|
|
|
||
Accounts payable
|
|
$
|
12,351
|
|
|
$
|
13,237
|
|
Accrued payroll
|
|
15,054
|
|
|
19,997
|
|
||
Accrued expenses and other current liabilities
|
|
16,002
|
|
|
11,668
|
|
||
Current portion of debt
|
|
17,202
|
|
|
—
|
|
||
Revolving line of credit
|
|
21
|
|
|
—
|
|
||
Total current liabilities
|
|
$
|
60,630
|
|
|
$
|
44,902
|
|
Deferred income taxes
|
|
201
|
|
|
879
|
|
||
Deferred rent
|
|
7,724
|
|
|
7,949
|
|
||
Other liabilities
|
|
3,877
|
|
|
3,783
|
|
||
Contingently issuable common stock
|
|
9,300
|
|
|
12,200
|
|
||
Debt
|
|
208,253
|
|
|
177,178
|
|
||
Total liabilities
|
|
$
|
289,985
|
|
|
$
|
246,891
|
|
Commitments and contingencies
|
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
|
||
Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized. No shares issued and outstanding.
|
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 135,000,000 shares authorized. 83,855,824 and 82,986,244 shares issued, respectively. 83,643,585 and 82,774,005 shares outstanding, respectively.
|
|
84
|
|
|
83
|
|
||
Additional paid-in capital
|
|
594,586
|
|
|
567,765
|
|
||
Accumulated deficit
|
|
(520,001
|
)
|
|
(453,601
|
)
|
||
Treasury stock, at cost, 212,239 and 212,239 shares, respectively.
|
|
(2,942
|
)
|
|
(2,942
|
)
|
||
Accumulated other comprehensive income
|
|
3,335
|
|
|
1,488
|
|
||
Total stockholders’ equity
|
|
$
|
75,062
|
|
|
$
|
112,793
|
|
Total liabilities and stockholders’ equity
|
|
$
|
365,047
|
|
|
$
|
359,684
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Revenue
|
$
|
181,157
|
|
|
$
|
192,925
|
|
|
$
|
153,612
|
|
Cost of goods sold
|
59,828
|
|
|
69,133
|
|
|
51,821
|
|
|||
Gross profit
|
121,329
|
|
|
123,792
|
|
|
101,791
|
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
21,019
|
|
|
32,337
|
|
|
26,421
|
|
|||
Clinical and regulatory affairs
|
12,952
|
|
|
16,215
|
|
|
15,418
|
|
|||
Marketing and sales
|
92,400
|
|
|
107,759
|
|
|
78,213
|
|
|||
General and administrative
|
35,301
|
|
|
41,044
|
|
|
29,581
|
|
|||
Restructuring costs
|
1,477
|
|
|
11,093
|
|
|
—
|
|
|||
Settlement costs
|
—
|
|
|
4,650
|
|
|
—
|
|
|||
Contract termination and business acquisition expenses
|
—
|
|
|
5,768
|
|
|
5,071
|
|
|||
Total operating expenses
|
163,149
|
|
|
218,866
|
|
|
154,704
|
|
|||
Loss from operations
|
(41,820
|
)
|
|
(95,074
|
)
|
|
(52,913
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Interest income
|
83
|
|
|
228
|
|
|
175
|
|
|||
Interest expense
|
(22,064
|
)
|
|
(15,841
|
)
|
|
(7,476
|
)
|
|||
Other income (expense), net
|
554
|
|
|
(2,161
|
)
|
|
553
|
|
|||
Change in fair value of contingent consideration related to acquisition
|
2,900
|
|
|
2,500
|
|
|
(100
|
)
|
|||
Loss on extinguishment of debt
|
(6,512
|
)
|
|
—
|
|
|
|
|
|||
Change in fair value of derivative liabilities
|
—
|
|
|
(43,831
|
)
|
|
—
|
|
|||
Total other income (expense)
|
(25,039
|
)
|
|
(59,105
|
)
|
|
(6,848
|
)
|
|||
Net loss before income tax benefit
|
(66,859
|
)
|
|
(154,179
|
)
|
|
(59,761
|
)
|
|||
Income tax benefit (expense)
|
459
|
|
|
(498
|
)
|
|
9,337
|
|
|||
Net loss
|
$
|
(66,400
|
)
|
|
$
|
(154,677
|
)
|
|
$
|
(50,424
|
)
|
Other comprehensive income (loss) foreign currency translation
|
1,847
|
|
|
978
|
|
|
(1,762
|
)
|
|||
Comprehensive loss
|
$
|
(64,553
|
)
|
|
$
|
(153,699
|
)
|
|
$
|
(52,186
|
)
|
|
|
|
|
|
|
|
|
|
|||
Basic and diluted net loss per share
|
$
|
(0.80
|
)
|
|
$
|
(1.91
|
)
|
|
$
|
(0.75
|
)
|
Shares used in computing basic and diluted loss per share
|
83,325
|
|
|
80,976
|
|
|
67,671
|
|
|
Common Stock
|
|
Additional
Paid-In Capital |
|
Accumulated
Deficit |
|
Treasury
Stock |
|
Accumulated Other Comprehensive Income (Loss)
|
|
Total Stockholders’
Equity |
|||||||||||||||
|
Issued Shares
|
|
$0.001 Par Value
|
|
|
|
|
|
||||||||||||||||||
Balance at December 31, 2014
|
67,322
|
|
|
$
|
67
|
|
|
$
|
372,639
|
|
|
$
|
(248,500
|
)
|
|
$
|
(2,328
|
)
|
|
$
|
2,272
|
|
|
$
|
124,150
|
|
Exercise of common stock options
|
397
|
|
|
1
|
|
|
2,870
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,871
|
|
||||||
Employee stock purchase plan
|
355
|
|
|
—
|
|
|
2,962
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,962
|
|
||||||
Treasury stock purchased
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(481
|
)
|
|
—
|
|
|
(481
|
)
|
||||||
Stock compensation expense
|
—
|
|
|
—
|
|
|
6,266
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,266
|
|
||||||
Issuance of restricted stock
|
161
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Restricted stock expense
|
—
|
|
|
—
|
|
|
2,843
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,843
|
|
||||||
Non-employee restricted stock expense
|
—
|
|
|
—
|
|
|
146
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
146
|
|
||||||
Equity conversion option
|
—
|
|
|
—
|
|
|
17,547
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
17,547
|
|
||||||
Debt issuance costs allocated to equity
|
—
|
|
|
—
|
|
|
(811
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(811
|
)
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(50,424
|
)
|
|
—
|
|
|
—
|
|
|
(50,424
|
)
|
||||||
Other comprehensive loss
|
—
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,762
|
)
|
|
(1,762
|
)
|
|||||||
Balance at December 31, 2015
|
68,235
|
|
|
68
|
|
|
404,462
|
|
|
(298,924
|
)
|
|
(2,809
|
)
|
|
510
|
|
|
103,307
|
|
||||||
Exercise of common stock options
|
524
|
|
|
2
|
|
|
3,127
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,129
|
|
||||||
Employee stock purchase plan
|
394
|
|
|
—
|
|
|
3,216
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,216
|
|
||||||
Issuance of common stock
|
13,587
|
|
|
13
|
|
|
100,799
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
100,812
|
|
||||||
Treasury stock purchased
|
11
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(133
|
)
|
|
—
|
|
|
(133
|
)
|
||||||
Stock compensation expense
|
—
|
|
|
—
|
|
|
8,541
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
8,541
|
|
||||||
Issuance of restricted stock
|
235
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Restricted stock expense
|
—
|
|
|
—
|
|
|
3,715
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,715
|
|
||||||
Non-employee restricted stock expense
|
—
|
|
|
—
|
|
|
30
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
30
|
|
||||||
Equity conversion option
|
—
|
|
|
—
|
|
|
43,875
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
43,875
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(154,677
|
)
|
|
—
|
|
|
—
|
|
|
(154,677
|
)
|
||||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
978
|
|
|
978
|
|
||||||
Balance at December 31, 2016
|
82,986
|
|
|
83
|
|
|
567,765
|
|
|
(453,601
|
)
|
|
(2,942
|
)
|
|
1,488
|
|
|
112,793
|
|
||||||
Exercise of common stock options
|
129
|
|
|
—
|
|
|
546
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
546
|
|
||||||
Employee stock purchase plan
|
446
|
|
|
1
|
|
|
2,518
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,519
|
|
||||||
Stock compensation expense
|
—
|
|
|
—
|
|
|
8,538
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
8,538
|
|
||||||
Issuance of restricted stock
|
294
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Restricted stock expense
|
—
|
|
|
—
|
|
|
3,027
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,027
|
|
||||||
Non-employee restricted stock expense
|
—
|
|
|
—
|
|
|
79
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
79
|
|
||||||
Equity conversion option
|
—
|
|
|
—
|
|
|
(2,235
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,235
|
)
|
||||||
Deerfield warrants
|
—
|
|
|
—
|
|
|
14,704
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
14,704
|
|
||||||
Debt issuance costs allocated to equity
|
—
|
|
|
—
|
|
|
(356
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(356
|
)
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(66,400
|
)
|
|
—
|
|
|
—
|
|
|
(66,400
|
)
|
||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,847
|
|
|
1,847
|
|
||||||
Balance at December 31, 2017
|
83,855
|
|
|
$
|
84
|
|
|
$
|
594,586
|
|
|
$
|
(520,001
|
)
|
|
$
|
(2,942
|
)
|
|
$
|
3,335
|
|
|
$
|
75,062
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(66,400
|
)
|
|
$
|
(154,677
|
)
|
|
$
|
(50,424
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Deferred income taxes
|
(696
|
)
|
|
—
|
|
|
(9,635
|
)
|
|||
Bad debt expense
|
(235
|
)
|
|
916
|
|
|
107
|
|
|||
Depreciation and amortization
|
9,111
|
|
|
9,149
|
|
|
5,886
|
|
|||
Stock-based compensation
|
11,644
|
|
|
12,286
|
|
|
9,255
|
|
|||
Change in fair value of derivative liabilities
|
—
|
|
|
43,831
|
|
|
—
|
|
|||
Change in fair value of contingent consideration related to acquisition
|
(2,900
|
)
|
|
(2,500
|
)
|
|
100
|
|
|||
Accretion of interest & amortization of deferred financing costs on convertible notes
|
10,165
|
|
|
9,539
|
|
|
4,842
|
|
|||
Accretion on marketable securities
|
—
|
|
|
(87
|
)
|
|
59
|
|
|||
Non-cash loss on debt extinguishment
|
3,997
|
|
|
—
|
|
|
—
|
|
|||
Loss on disposal of assets
|
—
|
|
|
123
|
|
|
58
|
|
|||
Non-cash foreign exchange (gain) loss
|
(678
|
)
|
|
2,112
|
|
|
(504
|
)
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Restricted cash
|
(607
|
)
|
|
(2,001
|
)
|
|
—
|
|
|||
Accounts receivable and other receivables
|
4,771
|
|
|
(2,911
|
)
|
|
(3,193
|
)
|
|||
Inventories
|
(3,035
|
)
|
|
3,540
|
|
|
3,528
|
|
|||
Prepaid expenses and other current assets
|
(1,034
|
)
|
|
1,070
|
|
|
167
|
|
|||
Accounts payable
|
(1,826
|
)
|
|
(5,152
|
)
|
|
8,342
|
|
|||
Accrued payroll
|
(5,176
|
)
|
|
7,079
|
|
|
(75
|
)
|
|||
Accrued expenses and other current liabilities
|
4,374
|
|
|
2,875
|
|
|
395
|
|
|||
Net cash used in operating activities
|
$
|
(38,525
|
)
|
|
$
|
(74,808
|
)
|
|
$
|
(31,092
|
)
|
Cash flows from investing activities:
|
|
|
|
|
|
||||||
Purchases of marketable securities
|
—
|
|
|
(20,976
|
)
|
|
(82,646
|
)
|
|||
Maturity on marketable securities
|
21,000
|
|
|
55,850
|
|
|
89,690
|
|
|||
Purchases of property and equipment
|
(1,170
|
)
|
|
(2,796
|
)
|
|
(4,191
|
)
|
|||
Acquisition of business, net of cash acquired of $24,012
|
—
|
|
|
(60,622
|
)
|
|
—
|
|
|||
Net cash provided by (used in) investing activities
|
$
|
19,830
|
|
|
$
|
(28,544
|
)
|
|
$
|
2,853
|
|
Cash flows from financing activities:
|
|
|
|
|
|
||||||
Net proceeds from revolving line of credit
|
21
|
|
|
—
|
|
|
—
|
|
|||
Deferred financing costs
|
(6,755
|
)
|
|
(918
|
)
|
|
(3,617
|
)
|
|||
Proceeds from sale of common stock under employee stock purchase plan
|
2,519
|
|
|
3,216
|
|
|
2,962
|
|
|||
Proceeds from exercise of stock options
|
546
|
|
|
3,129
|
|
|
2,871
|
|
|||
Proceeds from issuance of debt
|
120,000
|
|
|
—
|
|
|
125,000
|
|
|||
Repayment of debt
|
(66,613
|
)
|
|
—
|
|
|
—
|
|
|||
Minimum tax withholding paid on behalf of employees for restricted stock units
|
—
|
|
|
(133
|
)
|
|
(481
|
)
|
|||
Net cash provided by financing activities
|
$
|
49,718
|
|
|
$
|
5,294
|
|
|
$
|
126,735
|
|
Effect of exchange rate changes on cash and cash equivalents
|
848
|
|
|
(375
|
)
|
|
(741
|
)
|
|||
Net increase (decrease) in cash and cash equivalents
|
31,871
|
|
|
(98,433
|
)
|
|
97,755
|
|
|||
Cash and cash equivalents, beginning of year
|
26,120
|
|
|
124,553
|
|
|
26,798
|
|
|||
Cash and cash equivalents, end of year
|
$
|
57,991
|
|
|
$
|
26,120
|
|
|
$
|
124,553
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
9,836
|
|
|
$
|
6,262
|
|
|
$
|
1,957
|
|
Cash paid for income taxes
|
681
|
|
|
208
|
|
|
124
|
|
|||
Non-cash investing and financing activities:
|
|
|
|
|
|
||||||
Landlord funded leasehold improvements
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
46
|
|
Fair value of warrants issued for business acquisition
|
—
|
|
|
44
|
|
|
—
|
|
|||
Fair value of common stock issued for business acquisition
|
—
|
|
|
100,812
|
|
|
—
|
|
|||
Acquisition of property and equipment included in accounts payable
|
—
|
|
|
—
|
|
|
155
|
|
|||
Fair value of warrants issued in connection with the Facility Agreement
|
14,704
|
|
|
—
|
|
|
—
|
|
Property Class
|
|
Useful Life
|
Office furniture
|
|
Seven years
|
Computer hardware
|
|
Three years
|
Computer software
|
|
Three to eight years
|
Production equipment and molds
|
|
Three to seven years
|
Leasehold improvements
|
|
Shorter of expected useful life or remaining term of lease
|
Intangible Asset Class
|
|
Useful Life
|
Goodwill
|
|
Indefinite lived
|
Trademarks and tradenames
|
|
Indefinite lived
|
Developed technology
|
|
Eleven to thirteen years
|
Customer relationships
|
|
Ten years
|
•
|
Appropriate evidence of a binding arrangement exists with the customer;
|
•
|
The sales price for the EVAR or EVAS product (including device extensions and accessories) is established with the customer;
|
•
|
The EVAR or EVAS product has been used by the hospital in an EVAR procedure, or the distributor has assumed title with no right of return; and
|
•
|
Collection of the corresponding receivable from the customer is reasonably assured at the time of sale.
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Production equipment, molds, and office furniture
|
$
|
12,118
|
|
|
$
|
11,714
|
|
Computer hardware and software
|
8,115
|
|
|
8,162
|
|
||
Leasehold improvements
|
15,499
|
|
|
15,495
|
|
||
Construction in progress (software and related implementation, production equipment, and leasehold improvements)
|
743
|
|
|
839
|
|
||
Property and equipment, at cost
|
36,475
|
|
|
36,210
|
|
||
Accumulated depreciation
|
(17,263
|
)
|
|
(12,945
|
)
|
||
Property and equipment, net
|
$
|
19,212
|
|
|
$
|
23,265
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Goodwill
|
$
|
120,927
|
|
|
$
|
120,711
|
|
|
|
|
|
||||
Intangible assets:
|
|
|
|
|
|
||
Indefinite lived intangibles
|
|
|
|
||||
Trademarks and trade names
|
$
|
2,708
|
|
|
$
|
2,708
|
|
In-process research and development
|
11,200
|
|
|
11,200
|
|
||
|
|
|
|
||||
Finite lived intangibles
|
|
|
|
||||
Developed technology
|
$
|
67,600
|
|
|
$
|
67,600
|
|
Accumulated amortization
|
(7,167
|
)
|
|
(3,810
|
)
|
||
Developed technology, net
|
$
|
60,433
|
|
|
$
|
63,790
|
|
|
|
|
|
||||
Customer relationship
|
$
|
7,500
|
|
|
$
|
7,500
|
|
Accumulated amortization
|
(1,438
|
)
|
|
(687
|
)
|
||
Customer relationship, net
|
$
|
6,062
|
|
|
$
|
6,813
|
|
|
|
|
|
||||
Intangible assets (excluding goodwill), net
|
$
|
80,403
|
|
|
$
|
84,511
|
|
Balance at January 1, 2017
|
|
|
120,711
|
|
|
Foreign currency translation adjustment
|
|
|
216
|
|
|
Balance at December 31, 2017
|
|
|
$
|
120,927
|
|
|
Amortization Expense
|
||
2018
|
$
|
4,095
|
|
2019
|
4,300
|
|
|
2020
|
4,944
|
|
|
2021
|
7,020
|
|
|
2022
|
8,734
|
|
|
2023 and thereafter
|
37,402
|
|
|
Total
|
$
|
66,495
|
|
|
|
December 31, 2016
|
||||||||||||||
|
|
Amortized
Cost |
|
Gross
Unrealized Gain |
|
Gross
Unrealized Loss |
|
Fair Value
|
||||||||
Agency bonds
|
|
$
|
6,488
|
|
|
$
|
2
|
|
|
$
|
—
|
|
|
$
|
6,490
|
|
Corporate bonds
|
|
10,513
|
|
|
—
|
|
|
(21
|
)
|
|
$
|
10,492
|
|
|||
Commercial paper
|
|
3,987
|
|
|
—
|
|
|
—
|
|
|
3,987
|
|
||||
Total
|
|
$
|
20,988
|
|
|
$
|
2
|
|
|
$
|
(21
|
)
|
|
$
|
20,969
|
|
|
|
Fair value measurement at reporting date using:
|
||||||||||||||
|
|
Quoted prices in
active markets for identical assets (Level 1) |
|
Significant other
observable inputs (Level 2) |
|
Significant
unobservable inputs (Level 3) |
|
Total
|
||||||||
At December 31, 2017
|
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
|
$
|
57,991
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
57,991
|
|
Restricted cash
|
|
$
|
2,608
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,608
|
|
Contingently issuable common stock
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
9,300
|
|
|
$
|
9,300
|
|
At December 31, 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents
|
|
$
|
26,120
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
26,120
|
|
Restricted cash
|
|
$
|
2,001
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,001
|
|
Contingently issuable common stock
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
12,200
|
|
|
$
|
12,200
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Stock-based compensation expense
|
$
|
850
|
|
|
$
|
1,205
|
|
|
$
|
921
|
|
Common stock shares purchased by Company employees
|
446,490
|
|
|
394,120
|
|
|
355,557
|
|
|||
Average purchase price per share
|
$
|
5.64
|
|
|
$
|
8.17
|
|
|
$
|
8.33
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Cost of goods sold
|
$
|
828
|
|
|
$
|
944
|
|
|
$
|
1,000
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|||
Research and development
|
1,259
|
|
|
1,528
|
|
|
1,005
|
|
|||
Clinical and regulatory affairs
|
770
|
|
|
672
|
|
|
858
|
|
|||
Marketing and sales
|
3,796
|
|
|
4,335
|
|
|
3,237
|
|
|||
General and administrative
|
4,991
|
|
|
4,807
|
|
|
3,155
|
|
|||
Total operating expenses
|
$
|
10,816
|
|
|
$
|
11,342
|
|
|
$
|
8,255
|
|
|
|
|
|
|
|
|
|
|
|||
Total
|
$
|
11,644
|
|
|
$
|
12,286
|
|
|
$
|
9,255
|
|
|
Year Ended December 31,
|
||||
|
2017
|
|
2016
|
|
2015
|
Average expected option life (in years) (a)
|
5.6
|
|
5.5
|
|
5.5
|
Volatility (b)
|
51.3%
|
|
44.2%
|
|
43.3%
|
Risk-free interest rate (c)
|
1.9%
|
|
1.2%
|
|
1.6%
|
Dividend yield (d)
|
—
|
|
—
|
|
—
|
Weighted-average grant-date fair value per stock option
|
$2.51
|
|
$3.45
|
|
$6.37
|
|
Number of
Stock Options |
|
Weighted
Average Exercise Price |
|
Weighted-
Average Remaining Contractual Life (Years) |
|
Aggregate Intrinsic Value
|
||
Outstanding — January 1, 2017
|
8,673,215
|
|
9.22
|
|
|
|
|
|
|
Granted
|
5,370,408
|
|
5.44
|
|
|
|
|
|
|
Exercised
|
(129,478)
|
|
4.21
|
|
|
(a)
|
$
|
226
|
|
Forfeited
|
(1,405,534)
|
|
8.20
|
|
|
|
|
|
|
Expired
|
(684,279)
|
|
11.38
|
|
|
|
|
|
|
Outstanding — December 31, 2017
|
11,824,332
|
|
$7.56
|
|
7.1
|
(b)
|
$
|
4,570
|
|
Vested and Expected to Vest — December 31, 2017
|
10,629,743
|
|
7.67
|
|
6.9
|
(b)
|
$
|
4,173
|
|
Vested — December 31, 2017
|
5,041,775
|
|
8.48
|
|
4.9
|
(b)
|
$
|
2,530
|
|
|
|
Outstanding
|
|
Exercisable
|
||||||||||||||||
Range of Exercise Prices
|
|
Granted
Stock Options Outstanding |
|
Weighted-
Average Remaining Contractual Life (Years) |
|
Weighted-
Average Exercise Price |
|
Granted
Stock Options Exercisable |
|
Weighted-
Average Exercise Price |
||||||||||
$
|
1.64
|
|
—
|
$
|
4.42
|
|
|
2,390,446
|
|
5.6
|
|
$
|
3.76
|
|
|
1,135,219
|
|
$
|
3.27
|
|
4.49
|
|
—
|
6.62
|
|
|
3,626,065
|
|
8.6
|
|
5.72
|
|
|
691,585
|
|
5.72
|
|
||||
6.66
|
|
—
|
7.53
|
|
|
2,865,141
|
|
7.6
|
|
7.39
|
|
|
1,298,962
|
|
7.40
|
|
||||
7.57
|
|
—
|
15.51
|
|
|
2,373,560
|
|
5.9
|
|
12.22
|
|
|
1,543,700
|
|
12.52
|
|
||||
15.53
|
|
—
|
17.58
|
|
|
569,120
|
|
6.3
|
|
16.58
|
|
|
372,309
|
|
16.53
|
|
||||
$
|
1.64
|
|
—
|
$
|
17.58
|
|
|
11,824,332
|
|
7.1
|
|
$
|
7.56
|
|
|
5,041,775
|
|
$
|
8.48
|
|
|
Number of
Restricted Stock Awards(2) |
|
Weighted Average
Fair Value per Share at Grant Date |
|
Grant Date Fair Value
|
|
Vest Date Fair Value(1)
|
|||||||
Unvested as of December 31, 2016
|
1,310,019
|
|
|
$
|
10.19
|
|
|
|
|
|
|
|
||
Granted
|
1,590,662
|
|
|
5.01
|
|
|
$
|
7,969
|
|
|
|
|
||
Forfeited
|
(470,626
|
)
|
|
9.74
|
|
|
|
|
|
|
|
|||
Vested
|
(293,612
|
)
|
|
11.39
|
|
|
|
|
|
$
|
1,757
|
|
||
Unvested as of December 31, 2017
|
2,136,443
|
|
|
$
|
6.27
|
|
|
|
|
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Net loss
|
$
|
(66,400
|
)
|
|
$
|
(154,677
|
)
|
|
$
|
(50,424
|
)
|
Shares used in computing basic and diluted net loss per share
|
83,325
|
|
|
80,976
|
|
|
67,671
|
|
|||
Basic and diluted net loss per share
|
$
|
(0.80
|
)
|
|
$
|
(1.91
|
)
|
|
$
|
(0.75
|
)
|
|
Year Ended December 31,
|
||||
|
2017
|
|
2016
|
|
2015
|
Common stock options
|
520
|
|
1,248
|
|
1,651
|
Restricted stock awards
|
119
|
|
129
|
|
133
|
Restricted stock units
|
250
|
|
370
|
|
230
|
Total
|
889
|
|
1,747
|
|
2,014
|
|
Year Ended December 31,
|
||||
|
2017
|
|
2016
|
|
2015
|
Conversion of the Senior Notes
|
11,939
|
|
14,767
|
|
14,767
|
Deerfield Warrants
|
6,470
|
|
—
|
|
—
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
United States
|
$123,209
|
|
68.0%
|
|
$136,111
|
|
70.6%
|
|
$107,228
|
|
69.8%
|
Total International
|
57,948
|
|
32.0%
|
|
56,814
|
|
29.4%
|
|
46,384
|
|
30.2%
|
Revenue
|
$181,157
|
|
100%
|
|
$192,925
|
|
100%
|
|
$153,612
|
|
100%
|
2018
|
$
|
3,450
|
|
2019
|
3,567
|
|
|
2020
|
3,735
|
|
|
2021
|
3,692
|
|
|
2022
|
3,800
|
|
|
2023 and thereafter
|
18,021
|
|
|
Total
|
$
|
36,265
|
|
|
Fair Value of Contingently Issuable Common Stock
|
||
December 31, 2016
|
$
|
12,200
|
|
Fair value adjustment of Contingent Payment for year ended December 31, 2017
|
(2,900
|
)
|
|
December 31, 2017
|
$
|
9,300
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
United States
|
$
|
(56,178
|
)
|
|
$
|
(135,925
|
)
|
|
$
|
(44,114
|
)
|
Foreign
|
(10,681
|
)
|
|
(18,254
|
)
|
|
(15,647
|
)
|
|||
Net loss before income tax
|
$
|
(66,859
|
)
|
|
$
|
(154,179
|
)
|
|
$
|
(59,761
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
(102
|
)
|
|
$
|
(50
|
)
|
|
$
|
50
|
|
State
|
102
|
|
|
90
|
|
|
100
|
|
|||
Foreign
|
237
|
|
|
458
|
|
|
148
|
|
|||
Total current
|
$
|
237
|
|
|
$
|
498
|
|
|
$
|
298
|
|
Deferred:
|
|
|
|
|
|
||||||
Federal
|
$
|
(699
|
)
|
|
$
|
—
|
|
|
$
|
(8,621
|
)
|
State
|
—
|
|
|
—
|
|
|
(1,008
|
)
|
|||
Foreign
|
3
|
|
|
—
|
|
|
(6
|
)
|
|||
Total deferred
|
$
|
(696
|
)
|
|
$
|
—
|
|
|
$
|
(9,635
|
)
|
Total:
|
|
|
|
|
|
||||||
Federal
|
$
|
(801
|
)
|
|
$
|
(50
|
)
|
|
$
|
(8,571
|
)
|
State
|
102
|
|
|
90
|
|
|
(908
|
)
|
|||
Foreign
|
240
|
|
|
458
|
|
|
142
|
|
|||
Income tax expense (benefit)
|
$
|
(459
|
)
|
|
$
|
498
|
|
|
$
|
(9,337
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Income tax benefit at federal statutory rate
|
$
|
(22,732
|
)
|
|
$
|
(52,418
|
)
|
|
$
|
(20,315
|
)
|
State income tax benefit, net of federal benefit
|
(1,114
|
)
|
|
(2,323
|
)
|
|
(937
|
)
|
|||
Meals and entertainment
|
454
|
|
|
445
|
|
|
328
|
|
|||
Research and development credits
|
(913
|
)
|
|
(2,041
|
)
|
|
(1,756
|
)
|
|||
Stock-based compensation
|
3,203
|
|
|
2,604
|
|
|
1,633
|
|
|||
Derivative loss
|
—
|
|
|
14,903
|
|
|
—
|
|
|||
Contingent consideration
|
(986
|
)
|
|
(850
|
)
|
|
34
|
|
|||
Foreign tax rate differential
|
692
|
|
|
1,394
|
|
|
1,013
|
|
|||
Net change in valuation allowance
|
(24,976
|
)
|
|
35,678
|
|
|
10,052
|
|
|||
Return to provision true-up
|
5,719
|
|
|
1,981
|
|
|
583
|
|
|||
Unrecognized tax benefits
|
457
|
|
|
971
|
|
|
928
|
|
|||
Federal tax rate change
|
39,807
|
|
|
—
|
|
|
—
|
|
|||
Other, net
|
(70
|
)
|
|
154
|
|
|
(900
|
)
|
|||
Income tax benefit
|
$
|
(459
|
)
|
|
$
|
498
|
|
|
$
|
(9,337
|
)
|
|
Year Ended December 31,
|
||||||
|
2017
|
|
2016
|
||||
Deferred tax assets:
|
|
|
|
|
|
||
Net operating loss carryforwards
|
$
|
101,423
|
|
|
$
|
124,881
|
|
Accrued expenses
|
5,617
|
|
|
6,582
|
|
||
Tax credits
|
11,826
|
|
|
11,314
|
|
||
Bad debt
|
78
|
|
|
91
|
|
||
Inventory
|
2,160
|
|
|
4,424
|
|
||
Capitalized research and development
|
16,079
|
|
|
21,374
|
|
||
Deferred compensation
|
2,535
|
|
|
3,596
|
|
||
Other
|
1,099
|
|
|
964
|
|
||
Deferred tax asset
|
140,817
|
|
|
173,226
|
|
||
Valuation allowance
|
(118,551
|
)
|
|
(133,784
|
)
|
||
Total deferred tax assets
|
22,266
|
|
|
39,442
|
|
||
Deferred tax liabilities:
|
|
|
|
|
|
||
Developed technology and trademark
|
(9,033
|
)
|
|
(14,218
|
)
|
||
Trademarks and tradenames
|
(733
|
)
|
|
(1,027
|
)
|
||
Depreciation and amortization
|
(8,961
|
)
|
|
(15,316
|
)
|
||
Convertible debt
|
(3,740
|
)
|
|
(9,760
|
)
|
||
Other
|
—
|
|
|
—
|
|
||
Total deferred tax liabilities
|
(22,467
|
)
|
|
(40,321
|
)
|
||
Net deferred tax liability
|
$
|
(201
|
)
|
|
$
|
(879
|
)
|
|
Year Ended December 31, 2017
|
Year Ended December 31, 2016
|
||||
Balance at January 1, 2017
|
$
|
11,754
|
|
$
|
8,928
|
|
Additions for tax positions related to prior periods
|
—
|
|
1,654
|
|
||
Decreases related to prior year tax positions
|
(160
|
)
|
(95
|
)
|
||
Lapse of statute of limitations
|
—
|
|
—
|
|
||
Additions for tax positions related to current period
|
613
|
|
1,267
|
|
||
Balance at December 31, 2017
|
$
|
12,207
|
|
$
|
11,754
|
|
Three Months Ended:
|
Revenue
|
|
Gross Profit
|
|
Operating expenses
|
|
Net loss
|
|
Basic and Diluted loss per share
|
||||||||||
December 31, 2017
|
$
|
44,003
|
|
|
$
|
31,356
|
|
|
$
|
40,261
|
|
|
$
|
(14,521
|
)
|
|
$
|
(0.17
|
)
|
September 30, 2017
|
45,986
|
|
|
29,107
|
|
|
38,454
|
|
|
(14,273
|
)
|
|
(0.17
|
)
|
|||||
June 30, 2017
|
48,556
|
|
|
32,224
|
|
|
40,130
|
|
|
(16,292
|
)
|
|
(0.20
|
)
|
|||||
March 31, 2017
|
42,612
|
|
|
28,642
|
|
|
44,304
|
|
|
(21,314
|
)
|
|
(0.26
|
)
|
|||||
Three Months Ended:
|
|
|
|
|
|
|
|
|
|
||||||||||
December 31, 2016
|
$
|
47,463
|
|
|
$
|
29,461
|
|
|
$
|
51,669
|
|
|
$
|
(24,924
|
)
|
|
$
|
(0.30
|
)
|
September 30, 2016
|
52,122
|
|
|
36,931
|
|
|
48,165
|
|
|
(15,245
|
)
|
|
(0.18
|
)
|
|||||
June 30, 2016
|
50,974
|
|
|
29,459
|
|
|
52,687
|
|
|
(66,837
|
)
|
|
(0.81
|
)
|
|||||
March 31, 2016
|
42,366
|
|
|
27,941
|
|
|
66,345
|
|
|
(47,671
|
)
|
|
(0.62
|
)
|
|
One-time Termination Benefits
|
||
Accrual balance as of December 31, 2016
|
$
|
2,754
|
|
Restructuring charges
|
1,477
|
|
|
Utilization
|
(3,223
|
)
|
|
Accrual balance as of December 31, 2017
|
$
|
1,008
|
|
Cash consideration
|
$
|
84,634
|
|
Common stock consideration
|
100,812
|
|
|
Fair value of assumed TriVascular stock warrants
|
44
|
|
|
Total purchase consideration
|
$
|
185,490
|
|
Cash and cash equivalents
|
$
|
24,012
|
|
Short-term investments
|
3,008
|
|
|
Accounts receivable
|
5,780
|
|
|
Inventories
|
17,765
|
|
|
Prepaid expenses and other current assets
|
1,895
|
|
|
Property and equipment
|
3,152
|
|
|
Intangible assets
|
46,200
|
|
|
Other assets
|
317
|
|
|
Accounts payable
|
(2,214
|
)
|
|
Accrued liabilities and other
|
(6,450
|
)
|
|
Notes payable
|
(61
|
)
|
|
Net assets acquired
|
$
|
93,404
|
|
Goodwill
|
$
|
92,086
|
|
Total purchase consideration
|
$
|
185,490
|
|
|
Twelve Months Ended
|
||||||
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
Combined net sales
|
$
|
195,596
|
|
|
$
|
195,605
|
|
Combined net loss from continuing operations
|
(150,054
|
)
|
|
(113,534
|
)
|
||
Combined basic and diluted net loss per share
|
$
|
(1.82
|
)
|
|
$
|
(1.40
|
)
|
Item 9.
|
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
|
Item 9B.
|
Other Information
|
Item 10.
|
Directors, Executive Officers and Corporate Governance
|
Item 11.
|
Executive Compensation
|
Item 12.
|
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
|
Item 13.
|
Certain Relationships and Related Transactions, and Director Independence
|
Item 14.
|
Principal Accountant Fees and Services
|
Item 15.
|
Exhibits, Financial Statement Schedules
|
Column A
|
Column B
|
|
Column C
|
|
Column D
|
|
Column E
|
||||||||||||
|
|
|
Additions
(Reductions) |
|
|
|
|
||||||||||||
Description
|
Balance at
Beginning of Period |
|
Charged to Bad Debt Expense
|
|
Charged
to Other Accounts |
|
Deductions (1)
|
|
Balance at
End of Period |
||||||||||
|
(In thousands)
|
||||||||||||||||||
Year ended December 31, 2017
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
$
|
1,037
|
|
|
$
|
(235
|
)
|
|
$
|
—
|
|
|
$
|
(332
|
)
|
|
$
|
470
|
|
Year ended December 31, 2016
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
$
|
226
|
|
|
$
|
916
|
|
|
$
|
—
|
|
|
$
|
(105
|
)
|
|
$
|
1,037
|
|
Year ended December 31, 2015
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
$
|
185
|
|
|
$
|
107
|
|
|
$
|
—
|
|
|
$
|
(66
|
)
|
|
$
|
226
|
|
(1)
|
Deductions represent the actual write-off of accounts receivable balances.
|
Exhibit Number
|
|
Exhibit Description
|
|
Agreement and Plan of Merger and Reorganization, dated October 27, 2010, by and among Endologix, Inc., Nepal Acquisition Corporation, Nellix, Inc., certain of Nellix, Inc.’s stockholders listed therein and Essex Woodlands Health Ventures, Inc., as representative of Nellix, Inc.’s stockholders (Incorporated by reference to Exhibit 2.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on October 27, 2010).
|
|
|
Agreement and Plan of Merger, dated October 26, 2015, by and among Endologix, Inc., Teton Merger Sub, Inc. and TriVascular Technologies, Inc. (Incorporated by reference to Exhibit 2.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on October 26, 2015).
|
|
|
Amended and Restated Certificate of Incorporation, as amended (Incorporated by reference to Exhibit 3.1 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on August 5, 2016).
|
|
|
Amended and Restated Bylaws, as amended (Incorporated by reference to Exhibit 3.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on December 14, 2010).
|
|
4.1
|
|
Specimen Certificate of Common Stock (Incorporated by reference to Exhibit 4.1 to Amendment No. 2 to Endologix, Inc. Registration Statement on Form S-1, No. 333-04560, filed on June 10, 1996).
|
|
Updated Specimen Certificate of Common Stock effective as of May 22, 2014 (Incorporated by reference to Exhibit 4.1.1 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 2, 2015).
|
|
|
Indenture, dated December 10, 2013, between Endologix, Inc. and Wells Fargo Bank, National Association, as trustee (Incorporated by reference to Exhibit 4.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on December 10, 2013).
|
|
|
First Supplemental Indenture, dated December 10, 2013, between Endologix, Inc. and Wells Fargo Bank, National Association, as trustee (Incorporated by reference to Exhibit 4.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on December 10, 2013).
|
|
|
Form of 2.25% Convertible Senior Notes due 2018 (Incorporated by reference to Exhibit A to Exhibit 4.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on December 10, 2013).
|
|
|
Second Supplemental Indenture, dated November 2, 2015, between Endologix, Inc. and Wells Fargo Bank, National Association, as trustee (Incorporated by reference to Exhibit 4.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on November 2, 2015).
|
|
|
Form of 3.25% Convertible Senior Notes due 2020 (Incorporated by reference to Exhibit A to Exhibit 4.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on November 2, 2015).
|
|
|
Form of Warrant to Purchase Common Stock of Endologix, Inc., issued to Deerfield Private Design Fund IV, L.P., Deerfield International Master Fund, L.P., Deerfield Partners, L.P., and Deerfield Private Design Fund III, L.P., together with a schedule of holders and amounts (issued April 3, 2017) (Incorporated by reference to Exhibit 4.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 5, 2017).
|
|
|
Registration Rights Agreement, dated April 3, 2017, by and among Endologix, Inc., Deerfield Private Design Fund IV, L.P., Deerfield International Master Fund, L.P., Deerfield Partners, L.P., and Deerfield Private Design Fund III, L.P. (Incorporated by reference to Exhibit 4.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 5, 2017).
|
|
10.1
|
(1)
|
1997 Supplemental Stock Option Plan (Incorporated by reference to Exhibit 99.1 to Endologix, Inc. Registration Statement on Form S-8, No. 333-42161, filed on December 12, 1997).
|
(1)
|
1996 Stock Option/Stock Issuance Plan (Incorporated by reference to Exhibit 4.1 to Endologix, Inc. Registration Statement on Form S-8, No. 333-122491, filed on February 2, 2005).
|
|
(1)
|
2006 Stock Incentive Plan, as amended (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on May 24, 2013).
|
|
(1)
|
Form of Stock Option Agreement under 2006 Stock Incentive Plan (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on November 9, 2006).
|
|
(1)
|
Form of Restricted Stock Award Agreement under 2006 Stock Incentive Plan (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on November 9, 2006).
|
|
(1)
|
Form of Employee Restricted Stock Unit Award Agreement under 2006 Stock Incentive Plan (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on November 1, 2012).
|
|
(1)
|
Form of Director Restricted Stock Unit Award Agreement under 2006 Stock Incentive Plan (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on November 1, 2012).
|
(1)
|
Amended and Restated 2006 Employee Stock Purchase Plan, as amended (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on June 7, 2016).
|
|
(1)
|
2015 Stock Incentive Plan, as amended (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on June 2, 2017).
|
|
(1)
|
Form of Stock Option Agreement under 2015 Stock Incentive Plan (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on June 1, 2015).
|
|
(1)
|
Form of Restricted Stock Unit Award Agreement under 2015 Stock Incentive Plan (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on June 1, 2015).
|
|
(1)
|
2017 Inducement Stock Incentive Plan (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on October 30, 2017).
|
|
(1)
|
Employment Agreement, dated February 1, 2014, by and between Endologix, Inc. and John McDermott (Incorporated by reference to Exhibit 10.18 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 3, 2014).
|
|
(1)
|
Severance Agreement and General Release, dated February 21, 2018, by and between Endologix, Inc. and John McDermott (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on February 21, 2018).
|
|
(1)
|
Employment Agreement, dated February 25, 2016, by and between Endologix, Inc. and Vaseem Mahboob (Incorporated by reference to Exhibit 10.12 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on February 29, 2016).
|
|
(1)
|
Employment Agreement, dated February 1, 2014, by and between Endologix, Inc. and Robert D. Mitchell (Incorporated by reference to Exhibit 10.20 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 3, 2014).
|
|
(1)(2)
|
Separation Agreement and General Release, dated December 15, 2017, by and between Endologix, Inc. and Robert D. Mitchell, including the Agreement for Independent Contractor Services attached as Exhibit A thereto.
|
|
(1)(2)
|
Second Amendment to Restricted Stock Award Agreement, dated December 15, 2017, by and between Endologix, Inc. and Robert D. Mitchell.
|
|
(1)
|
Employment Agreement, dated as of February 3, 2016, by and between Endologix, Inc. and Michael Chobotov, Ph.D. (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on May 5, 2017).
|
|
(1)
|
Employment Agreement, dated as of February 3, 2016, by and between Endologix, Inc. and Shari O’Quinn (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on May 5, 2017).
|
|
(1)
|
Form of Indemnification Agreement entered into with Endologix, Inc. officers and directors (Incorporated by reference to Exhibit 10.23 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 3, 2014).
|
|
(1)
|
Employment Agreement, dated as of October 30, 2017, by and between Endologix, Inc. and John Onopchenko (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on November 7, 2017).
|
|
|
Standard Industrial/Commercial Single-Tenant Lease - Net, dated November 2, 2004, by and between Endologix, Inc. and Del Monico Investments, Inc. (Incorporated by reference to Exhibit 10.46 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on November 24, 2004).
|
|
|
Addendum No. 2 to Standard Industrial/Commercial Single-Tenant Lease - Net, by and between Endologix, Inc. and Del Monico Investments, Inc., dated June 9, 2009 (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on November 2, 2009).
|
|
|
Addendum No. 3 to Standard Industrial/Commercial Single-Tenant Lease - Net, by and between Endologix, Inc. and Del Monico Investments, Inc., dated June 9, 2009 (Incorporated by reference to Exhibit 10.17.2 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 2, 2015).
|
|
|
Addendum No. 4 to Standard Industrial/Commercial Single-Tenant Lease - Net, by and between Endologix, Inc. and Del Monico Investments, Inc., dated June 9, 2009 (Incorporated by reference to Exhibit 10.17.3 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 2, 2015).
|
|
|
Standard Industrial/Commercial Multi -Tenant Lease - Net, by and between Endologix, Inc. and Four-In-One Associates, dated August 28, 2009 (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on November 2, 2009).
|
|
|
Addendum No. 3 to Standard Industrial/Commercial Multi -Tenant Lease - Net, by and between Endologix, Inc. and Four-In-One Associates, dated August 28, 2009 (Incorporated by reference to Exhibit 10.18.1 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 2, 2015).
|
|
Standard Industrial/Commercial Multi-Tenant Lease - Net, for 2 Musick, Irvine, California and 35 Hammond, Irvine, dated June 12, 2013, by and between Endologix, Inc. and The Northwestern Mutual Life Insurance Company (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed with on August 5, 2013).
|
|
†
|
Cross License Agreement dated as of October 26, 2011, by and between Endologix, Inc. and Bard Peripheral Vascular, Inc. (Incorporated by reference to Exhibit 10.19 to Endologix Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 6, 2012).
|
|
†
|
Settlement Agreement, dated October 16, 2012 by and among Endologix, Inc., Cook Incorporated, Cook Group and Cook Medical, Inc. (Incorporated by reference to Exhibit 10.22 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed with on March 14, 2013).
|
|
|
Base Capped Call Confirmation, dated December 4, 2013, between Endologix, Inc. and Bank of America, N.A. (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on December 6, 2013).
|
|
|
Additional Capped Call Confirmation, dated December 5, 2013, between Endologix, Inc. and Bank of America, N.A. (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on December 6, 2013).
|
|
|
Facility Agreement, dated April 3, 2017, by and among Endologix, Inc., certain subsidiaries of Endologix, Inc., Deerfield Private Design Fund IV, L.P., Deerfield International Master Fund, L.P., Deerfield Partners, L.P., and Deerfield Private Design Fund III, L.P. (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 5, 2017).
|
|
|
Credit and Security Agreement, dated April 3, 2017, by and among Endologix, Inc., certain subsidiaries of Endologix, Inc. and Deerfield ELGX Revolver, LLC. (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 5, 2017).
|
|
(2)
|
Lease Agreement, dated June 16, 2005, by and among TriVascular, Inc., Carmel River, LLC, Carlsen Investments, LLC, and Rieger Investments, LLC.
|
|
(2)
|
Consent, Assignment, First Amendment to Lease and Non-Disturbance Agreement, dated March 28, 2008, by and among Boston Scientific Santa Rosa Corp., Carmel River, LLC, Carlsen Investments, LLC, Rieger Investments, LLC, and Boston Scientific Corporation.
|
|
(2)
|
Second Amendment to Lease, dated December 6, 2011, by and among TriVascular, Inc., Sonoma Airport Properties LLC and Boston Scientific Corporation.
|
|
|
Third Amendment to Lease, by and between TriVascular, Inc. and Sonoma Airport Properties LLC, dated July 3, 2017 (Incorporated by reference to Exhibit 10.4 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on August 4, 2017).
|
|
(2)
|
Computation of Ratio of Earnings to Fixed Charges.
|
|
|
Code of Ethics for Chief Executive Officer and Principal Financial Officers (Incorporated by reference to Exhibit 14 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 26, 2004).
|
|
(2)
|
List of Subsidiaries.
|
|
(2)
|
Consent of Independent Registered Public Accounting Firm (KPMG LLP).
|
|
(2)
|
Power of Attorney (included on signature page hereto).
|
|
(2)
|
Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934.
|
|
(2)
|
Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934.
|
|
(2)(3)
|
Certification of Chief Executive Officer Pursuant to Rule 13a-14(b)/15d-14(b) under the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350.
|
|
(2)(3)
|
Certification of Chief Financial Officer Pursuant to Rule 13a-14(b)/15d-14(b) under the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350.
|
|
101.INS
|
(2)
|
XBRL Instance Document
|
101.SCH
|
(2)
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
(2)
|
XBRL Taxonomy Extension Calculation Link Base Document
|
101.DEF
|
(2)
|
XBRL Taxonomy Extension Definition Link Base Document
|
101.LAB
|
(2)
|
XBRL Taxonomy Extension Label Link Base Document
|
101.PRE
|
(2)
|
XBRL Taxonomy Extension Presentation Link Base Document
|
†
|
Portions of this exhibit are omitted and were filed separately with the SEC pursuant to Endologix Inc.'s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
|
(1)
|
These exhibits are identified as management contracts or compensatory plans or arrangements of the registrant pursuant to Item 15(a)(3) of Form 10-K.
|
(2)
|
Filed herewith.
|
(3)
|
Furnished herewith and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
|
Item 16.
|
Form 10-K Summary.
|
ENDOLOGIX, INC.
|
||
|
|
|
By:
|
|
/
S
/ J
OHN
M
C
D
ERMOTT
|
|
|
John McDermott
Chief Executive Officer
(Principal Executive Officer)
|
Signature
|
|
Title
|
|
Date
|
|
|
|
||
/s/ JOHN McDERMOTT
|
|
Chief Executive Officer
|
|
March 13, 2018
|
(John McDermott)
|
|
(Principal Executive Officer)
|
|
|
|
|
|
||
/s/ VASEEM MAHBOOB
|
|
Chief Financial Officer
|
|
March 13, 2018
|
(Vaseem Mahboob )
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
||
|
|
|
||
/s/ DAN LEMAITRE
|
|
Chairman of the Board
|
|
March 13, 2018
|
(Dan Lemaitre)
|
|
|
|
|
|
|
|
||
/s/ THOMAS F. ZENTY III
|
|
Director
|
|
March 13, 2018
|
(Thomas F. Zenty III)
|
|
|
|
|
|
|
|
||
/s/ THOMAS C. WILDER
|
|
Director
|
|
March 13, 2018
|
(
Thomas C. Wilder
)
|
|
|
|
|
|
|
|
||
/s/ GUIDO J. NEELS
|
|
Director
|
|
March 13, 2018
|
(
Guido J. Neels
)
|
|
|
|
|
|
|
|
||
/s/ GREGORY D. WALLER
|
|
Director
|
|
March 13, 2018
|
(Gregory D. Waller)
|
|
|
|
|
|
|
|
||
/s/ LESLIE V. NORWALK
|
|
Director
|
|
March 13, 2018
|
(Leslie V. Norwalk)
|
|
|
|
|
|
|
|
|
|
/s/ CHRISTOPHER G. CHAVEZ
|
|
Director
|
|
March 13, 2018
|
(Christopher G. Chavez)
|
|
|
|
|
DATED:
December 15, 2017
|
ROBERT D. MITCHELL
/s/ Robert D. Mitchell
(Signature)
|
DATED:
December 15, 2017
|
ENDOLOGIX, INC.
By:
/s/ John McDermott
John McDermott
Chief Executive Officer
|
|
|
|
Section 1.01.
Date of Lease:
June 16, 2005
|
|
|
|
|
|
Address of Landlord:
|
|
c/o PDC Properties, Inc.
|
|
|
8395 Jackson Road, Suite F
|
|
|
Sacramento, CA 95826
|
|
|
|
Section 1.03.
Tenant
(include legal entity):
|
|
TriVascular, Inc.
|
|
|
a California corporation
|
Address of Tenant:
|
|
3910 Brickway Boulevard
|
|
|
Santa Rosa, CA 95403
|
|
|
||
Months
|
Monthly Rent
|
||
9/1/2005 to 2/28/2006
|
$
|
—
|
|
3/1/2006 to 2/28/2007
|
$
|
74,970.00
|
|
3/1/2007 to 2/29/2008
|
$
|
77,175.00
|
|
3/1/2008 to 2/28/2009
|
$
|
79,380.00
|
|
3/1/2009 to 2/28/2010
|
$
|
81,585.00
|
|
3/1/2010 to 2/28/2011
|
$
|
83,790.00
|
|
|
|
|
ARTICLE SIXTEEN:
|
|
RENEWAL OPTION
|
ARTICLE SEVENTEEN:
|
|
TENANT IMPROVEMENTS
|
ARTICLE EIGHTEEN:
|
|
RESERVED
|
ARTICLE NINETEEN:
|
|
RIGHT OF FIRST REFUSAL TO PURCHASE BUILDING
|
ARTICLE TWENTY:
|
|
ROOF ACCESS AND CONDUIT ACCESS
|
ARTICLE TWENTY-ONE:
|
|
CONDITIONS PRECEDENT TO EFFECTIVENESS OF LEASE
|
|
|
|
Exhibit A:
|
|
Premises, Building, Project and Center Description.
|
Exhibit B:
|
|
Form of Landlord’s Estoppel Certificate.
|
Exhibit C:
|
|
Signage.
|
Exhibit D:
|
|
Form of Lender’s Estoppel Certificate.
|
Exhibit E:
|
|
Subordination, Nondistrubance and Attornment Agreement.
|
Exhibit F:
|
|
Lease Guaranty.
|
|
|
“LANDLORD”
|
|
|
|
CARMEL RIVER, LLC,
|
|
a Delaware limited liability company
|
|
|
|
|
By:
|
/s/ Carl D. Panattoni
|
|
Carl D. Panattoni, Trustee of the Panattoni Living Trust, dated April 8, 1998, Managing Member
|
|
|
|
|
CARLSEN INVESTMENTS, LLC,
a California limited liability company
|
|
|
|
|
By:
|
/s/ James Carlsen
|
Name:
|
James Carlsen, Managing Member
|
|
|
|
|
||
RIEGER INVESTMENTS, LLC,
a Delaware limited liability company
|
|
|
|
|
By:
|
/s/ Jacklyn Shelby
|
Name:
|
Jacklyn Shelby, Managing Member
|
|
|
|
|
|
“TENANT”
|
|
|
|
TRIVASCULAR, INC.,
a California corporation
|
|
|
By:
|
/s/ James H. Taylor Jr. 6/22/05
|
Name:
|
James H. Taylor Jr.
|
Title:
|
Executive V.P. Operations
|
|
|
By:
|
/s/ Charles E. Pappalardo
|
Name:
|
Charles E. Pappalardo
|
Title:
|
Vice President Global Facilities
|
|
|
|
|
|
|
|
To:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
|
Re: [Property Address]
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TENANT:
|
|
|
||||||
|
|
a
|
|
|
||||
|
|
|
||||||
|
|
By:
|
|
|
||||
|
|
|
|
|
|
Its:
|
|
|
|
UNION BANK OF CALIFORNIA, N.A.
|
|
|
|
|
|
|
Re: Lease Dated:
|
|
<Date of Lease>
|
[Original Landlord:]
|
|
<Name of Original Landlord>
|
[Original Tenant:]
|
|
<Name of Original Tenant>
|
[Current Landlord:]
|
|
<Name of Current Landlord>
|
[Current Tenant:]
|
|
<Name of Current Tenant>
|
Property:
|
|
<Address of Collateral Property>
|
Premises:
|
|
<Identification of Leased Premises (free text input)>
|
Commencement Date:
|
|
<Starting date of Lease/Sublease>
|
Termination Date:
|
|
<Ending date of Lease/Sublease>
|
Current Monthly Rent:
|
|
<Current Monthly Rent ($dollars)>
|
Security Deposit:
|
|
<Amount of Security Deposit ($dollars)>
|
|
|
|
|
|
Tenant Estoppel Certificate (08/14/02)
|
|
|
|
|
CORE DOCUMENT (12/10/02)
|
|
|
|
|
|
|
|
|
|
Tenant Estoppel Certificate (08/14/02)
|
|
|
|
|
CORE DOCUMENT (12/10/02)
|
|
|
|
|
|
|
|
[NAME OF TENANT]
|
||
|
|
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
|
|
|
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
|
|
|
|
|
|
Tenant Estoppel Certificate (08/14/02)
|
|
|
|
|
CORE DOCUMENT (12/10/02)
|
|
|
|
|
|
RECORDING REQUESTED BY
|
|
UNION BANK OF CALIFORNIA, N.A.
|
|
AND WHEN RECORDED MAIL TO:
|
|
UNION BANK OF CALIFORNIA, N.A.
|
Attn.:
|
|
|
|
|
|
|
|
Tenant Estoppel Certificate (08/14/02)
|
|
|
|
|
CORE DOCUMENT (12/10/02)
|
|
|
|
|
|
|
|
|
|
Tenant Estoppel Certificate (08/14/02)
|
|
|
|
|
CORE DOCUMENT (12/10/02)
|
|
|
|
|
|
|
|
|
|
Tenant Estoppel Certificate (08/14/02)
|
|
|
|
|
CORE DOCUMENT (12/10/02)
|
|
|
|
|
|
BANK:
|
Union Bank of California, N.A.
|
|
By:
|
Name:
|
Title:
|
|
TENANT:
<<Name of Tenant/Sublessee>>
|
a
|
|
By:
|
Name:
|
Title:
|
|
By:
|
Name:
|
Title:
|
|
|
|
|
|
Tenant Estoppel Certificate (08/14/02)
|
|
|
|
|
CORE DOCUMENT (12/10/02)
|
|
|
|
|
|
|
|
|
|
Tenant Estoppel Certificate (08/14/02)
|
|
|
|
|
CORE DOCUMENT (12/10/02)
|
|
|
|
|
|
|
|
|
|
Tenant Estoppel Certificate (08/14/02)
|
|
|
|
|
CORE DOCUMENT (12/10/02)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WITNESS:
|
|
|
|
GUARANTOR:
|
||||
|
|
|
||||||
Pamela Campis
|
|
|
|
BOSTON SCIENTIFIC CORPORATION INC.
|
||||
|
|
|
|
|||||
|
|
|
|
By:
|
|
/s/ James H. Taylor Jr.
|
||
|
|
|
|
|
|
Name:
|
|
James H. Taylor Jr.
|
|
|
|
|
|
|
Title:
|
|
Executive V.P. Operations
|
|
|
||
Months
|
Monthly Rent
|
||
3/1/2011 to 2/28/2012
|
$
|
85,995
|
|
3/1/2012 to 2/28/2013
|
$
|
88,200
|
|
|
|
|
Landlord:
|
||
|
||
CARMEL RIVER, LLC,
|
||
a Delaware limited liability company
|
||
|
|
|
By:
|
|
/s/ Carl D. Panattoni
|
|
|
Carl D. Panattoni, Trustee of the
Panattoni Living Trust, dated
April 8, 1998, Managing Member
|
|
||
CARLSEN INVESTMENTS, LLC,
a California limited liability company
|
||
|
|
|
By:
|
|
/s/ James Carlsen
|
|
|
James Carlsen, Managing Member
|
|
||
RIEGER INVESTMENTS, LLC,
a Delaware limited liability company
|
||
|
|
|
By:
|
|
/s/ Jacklyn Shelby
|
|
|
Jacklyn Shelby, Managing Member
|
|
||
Tenant:
|
||
|
||
Exiting Tenant:
|
||
|
||
BOSTON SCIENTIFIC SANTA ROSA CORP.,
a California corporation
|
||
|
|
|
By:
|
|
/s/ Lawrence J. Knopf
|
Name:
|
|
Lawrence J. Knopf
|
Title:
|
|
Assistant Secretary
|
|
|
|
New Tenant:
|
||
|
||
BOSTON SCIENTIFIC CORPORATION,
a Delaware corporation
|
||
|
|
|
By:
|
|
/s/ Paul LaViolette
|
Name:
|
|
Paul LaViolette
|
Title:
|
|
Chief Operating Officer
|
|
||
Guarantor:
|
||
|
||
BOSTON SCIENTIFIC CORPORATION,
a Delaware corporation
|
||
|
|
|
By:
|
|
/s/ Paul LaViolette
|
Name:
|
|
Paul LaViolette
|
Title:
|
|
Chief Operating Officer
|
Months
|
|
Monthly Rent
|
|
|
||
3/1/2013 to 2/28/2014
|
|
$
|
88,200
|
|
|
($0.80/sf)
|
3/1/2014 to 2/28/2015
|
|
$
|
90,405
|
|
|
($0.82/sf)
|
3/1/2015 to 2/28/2016
|
|
$
|
92,610
|
|
|
($0.84/sf)
|
3/1/2016 to 2/28/2017
|
|
$
|
94,815
|
|
|
($0.86/sf)
|
3/1/2017 to 2/28/2018
|
|
$
|
97,020
|
|
|
($0.88/sf)
|
|
|
|
|
|
|
|
|
|
LANDLORD:
|
|
|
|
TV:
|
||||
|
|
|
||||||
SONOMA AIRPORT PROPERTIES LLC,
|
|
|
|
TRIVASCULAR, INC.,
|
||||
a California limited liability company
|
|
|
|
a California corporation
|
||||
|
|
|
|
|
||||
By:
|
|
/s/ RON PROFILI
|
|
|
|
By:
|
|
/s/ Michael Kramer
|
Name:
|
|
RON PROFILI
|
|
|
|
Name:
|
|
Michael Kramer
|
Title:
|
|
MANAGING MEMBER
|
|
|
|
Title:
|
|
Chief Financial Officer
|
|
|
|
|
|||||
BSC:
|
|
|
|
|
|
|
||
|
|
|
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BOSTON SCIENTIFIC CORPORATION,
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a Delaware corporation
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By:
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/s/ ED ZIELINSKI
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Name:
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ED ZIELINSKI
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Title:
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VICE PRESIDENT GLOBAL
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REAL ESTATE AND FACILITIES
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Endologix, Inc.
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Computation of Ratios of Earnings to Fixed Charges
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(in thousands)
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Year Ended December 31,
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2017
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2016
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2015
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2014
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2013
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2012
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EARNINGS:
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Loss before income taxes
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$
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(66,859
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)
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$
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(154,179
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)
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$
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(59,761
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)
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$
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(32,480
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)
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$
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(16,078
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)
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$
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(35,243
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)
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Plus: Fixed charges (see below)
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$
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23,185
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$
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16,954
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$
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8,229
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$
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6,617
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$
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521
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$
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203
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Total earnings/(loss) to cover fixed charges
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$
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(43,674
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)
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$
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(137,225
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)
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$
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(51,532
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)
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$
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(25,863
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)
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$
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(15,557
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)
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$
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(35,040
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)
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FIXED CHARGES:
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Interest expense
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$
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22,064
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$
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15,841
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$
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7,476
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$
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5,709
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$
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321
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$
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7
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Interest portion of rental expense (1)
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$
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1,121
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$
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1,113
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$
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753
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$
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908
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$
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200
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$
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196
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Total Fixed charges
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$
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23,185
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$
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16,954
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$
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8,229
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$
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6,617
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$
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521
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$
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203
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Preferred stock dividends
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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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—
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$
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—
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$
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—
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Combined fixed charges and preferred stock dividends
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$
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23,185
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$
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16,954
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$
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8,229
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$
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6,617
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$
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521
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$
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203
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RATIO OF EARNINGS TO FIXED CHARGES
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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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RATIO OF EARNINGS TO COMBINED FIXED CHARGES AND PREFERRED STOCK DIVIDENDS
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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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DEFICIENCY OF EARNINGS TO COVER FIXED CHARGES
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$
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(66,859
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)
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$
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(154,179
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)
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$
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(59,761
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)
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$
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(32,480
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)
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$
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(16,078
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)
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$
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(35,243
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)
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DEFICIENCY OF EARNINGS TO COVER COMBINED FIXED CHARGES AND PREFERRED STOCK DIVIDENDS
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$
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(66,859
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)
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$
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(154,179
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)
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$
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(59,761
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)
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$
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(32,480
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)
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$
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(16,078
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)
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$
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(35,243
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)
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(1
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Amounts represent those portions of rent expense (one-third) that are reasonable approximations of interest costs.
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1.
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CVD/RMS Acquisition Corp., a Delaware corporation.
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2.
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Nellix, Inc., a Delaware corporation.
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3.
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ELGX International Holdings GP, a Cayman Islands company.
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4.
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Endologix International Holdings B.V., a Dutch corporation.
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5.
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ELGX South Korea Ltd.
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6.
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Endologix International B.V., a Dutch corporation.
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7.
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Endologix New Zealand Co., a New Zealand unlimited liability company.
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8.
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Endologix Bermuda L.P., a Bermuda partnership.
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9.
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Endologix Italia S.r.l., an Italian corporation.
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1.
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I have reviewed this Annual Report on Form 10-K of Endologix, Inc.;
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2.
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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;
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3.
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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;
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4.
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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 we have:
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a)
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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;
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b)
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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 reporting purposes in accordance with generally accepted accounting principals;
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c)
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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
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d)
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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
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5.
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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 registrant's board of directors (or persons performing the equivalent functions):
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a)
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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
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b)
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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.
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March 13, 2018
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By:
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/s/ JOHN MCDERMOTT
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John McDermott
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Chief Executive Officer
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1.
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I have reviewed this Annual Report on Form 10-K of Endologix, Inc.;
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2.
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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;
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3.
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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;
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4.
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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 we have:
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a)
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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;
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b)
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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 reporting purposes in accordance with generally accepted accounting principals;
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c)
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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
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d)
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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
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5.
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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 registrant's board of directors (or persons performing the equivalent functions):
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a)
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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
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b)
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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.
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March 13, 2018
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By:
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/s/ VASEEM MAHBOOB
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Vaseem Mahboob
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Chief Financial Officer
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(1)
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The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ JOHN MCDERMOTT
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John McDermott
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Chief Executive Officer
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(1)
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The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2)
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ VASEEM MAHBOOB
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Vaseem Mahboob
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Chief Financial Officer
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