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Share Name | Share Symbol | Market | Type |
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Endologix Inc | NASDAQ:ELGX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 0.22 | 0.2344 | 0.24 | 0 | 01:00:00 |
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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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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Trading Symbol(s)
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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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ELGX
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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
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Smaller reporting company
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x
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Emerging growth company
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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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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.
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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, backed by robust, high-quality clinical evidence;
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Design EVAR and EVAS products which generate compelling clinical evidence, supporting expansion into additional aortic indications;
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Offer physicians and hospitals the best clinical options for each individual patient; and
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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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1,652
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$
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503
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$
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2,155
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Complex
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533
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857
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1,390
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Total
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$
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2,185
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$
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1,360
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$
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3,545
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Men aged 65 to 75 years who have ever smoked. The USPSTF recommends one-time screening for AAA with ultrasonography in men aged 65 to 75 years who have ever smoked.
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Men aged 65 to 75 years who have never smoked. The USPSTF recommends that clinicians selectively offer screening for AAA with ultrasonography in men ages 65 to 75 years who have never smoked rather than routinely screening all men in this group. Evidence indicates that the net benefit of screening all men in this group is small. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the balance of benefits and harms on the basis of evidence relevant to the patient’s medical history, family history, other risk factors, and personal values.
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Women aged 65 to 75 years who have ever smoked. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for AAA with ultrasonography in women aged 65 to 75 years who have ever smoked or have a family history of AAA.
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Women who have never smoked. The USPSTF recommends against routine screening for AAA with ultrasonography in women who have never smoked and have no family history of AAA.
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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 (commonly referred to as “anatomical fixation”). 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 United States Food and Drug Administration (“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, 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 overall 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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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 5-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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Powerlink System for AAA. The Powerlink System for AAA was our original EVAR product.
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IntuiTrak. We received FDA approval for IntuiTrak in October 2008, CE Mark approval for IntuiTrak in March 2010, and Shonin approval from the Japanese Ministry of Health, Labor and Welfare (“MHLW”) 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. 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 iX Abdominal Stent Graft System. In September 2015, the first patients were treated with the Ovation iX Abdominal Stent Graft System in Europe, and in October 2015, we initiated the launch of our Ovation iX Iliac Stent Graft System in the United States.
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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 Investigational Device Exemption (“IDE”) approval in the United States to begin a clinical trial of the Nellix EVAS System 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 receipt of CE Mark approval of the next-generation Nellix EVAS System, and in September 2017, we further announced CE Mark approval for the Nellix EVAS System with the refined IFU. In May 2017, we announced that we would conduct a confirmatory IDE study in the United States, called the EVAS2 IDE Multicenter Safety and Effectiveness Confirmatory Study (“EVAS2”), to further evaluate the next-generation Nellix EVAS System, and in October 2017, we received IDE approval in the United States to commence EVAS2. In early January 2019, we announced that our Nellix EVAS System would for the foreseeable future only be used under clinical protocol with pre-screened patients in procedures that adhere to the current indications for use. In mid-January 2019, we announced that the CE Mark for the Nellix EVAS System had been suspended by our notified body (an organization designated by the EU to regularly assess the conformity of certain products under applicable legislation before being placed on the market, a “Notified Body”). In June 2019, we announced that the CE Mark for the Nellix EVAS System had been reinstated by GMED, the EU Notified Body for the Nellix EVAS System. The reinstatement followed an assessment of clinical evidence.
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ChEVAS. Chimney EndoVascular Aneurysm Sealing (“ChEVAS”) is a procedure where the Nellix EVAS System could be used together with aortic branch stent grafts to treat patients with complex AAAs. Physicians initiated a clinical trial called Aneurysm Study for Complex AAA: Evaluation of Nellix Durability (“ASCEND”) to evaluate the clinical performance of ChEVAS. In August 2019, we announced the IDE approval for the Nellix ChEVAS Protocol. This study will recruit 120 patients from up to 50 centers, both in the U.S. and internationally. We expect enrollment to begin in 2020.
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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 (95.1%), rupture (99.4%), and all-cause mortality (93.8%) among all patients.
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Highest freedom of type II endoleaks, of 96.6%, 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 95.9% 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 FDA approval of the Nellix EVAS System by conducting a confirmatory clinical study with the refined IFU and our next generation Nellix device design, the “Nellix 3.5 EVAS System.” The Nellix 3.5 EVAS System 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 Nellix 3.5 EVAS System for the endovascular treatment of infrarenal AAA. EVAS2 will prospectively evaluate the refined IFU and the Nellix 3.5 EVAS System. The study is approved to enroll up to 105 primary patients, with one-year follow-up data required for the pre-market approval (“PMA”) application. We commenced EVAS2 patient enrollment in March 2018 and expect to complete enrollment in early 2020.
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EVAS FORWARD Global Registry. This registry 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, and 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 Symposium on Vascular and Endovascular Issues (the “VEITH Symposium”). The following outcomes were presented at the VEITH Symposium:
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37% of the patients had complex anatomies;
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98.1% freedom from any persistent endoleaks at latest follow-up;
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No secondary interventions for Type II endoleaks;
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97.4% freedom from aneurysm-related mortality; and
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98.5% 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, 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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No Type III endoleaks and low Type I endoleaks (0.4%);
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Fast-Track completed in 216 patients (87%), 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% versus 18%;
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ICU stay 0% versus 32%; and
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Mean hospital stay 1.2 days versus 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;
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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 0.1mm, compared to 5.3mm as reported with other EVAR devices;
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96.6% freedom from secondary interventions related to Type I endoleak; and
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No migration or conversions.
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99% freedom from AAA-related mortality;
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99% freedom from conversion;
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99% freedom from rupture;
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96% freedom from reintervention for Type Ia endoleak; and
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92% freedom from all device-related reintervention.
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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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$40,929
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Aortic and Heart Assist Procedures Except Pulsation Balloon without MCC
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$25,343
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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 which engage in bribery when doing business with physicians, distributors, agents, and other third parties outside of the United States. Many physicians outside of 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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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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physicians and hospitals may continue relying on (or revert back to) open surgical repair, or use the other approved EVAR devices available for patients;
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our direct sales force may not be large enough, or effective enough in its efforts, to train and educate physicians and hospitals about the benefits of our products so as to drive adoption and continued use of our products;
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coverage and reimbursement for our products may not be sufficient for customers to choose our devices when in need of an EVAR device;
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challenges in the manufacturing, validation and testing of our products may require us to take actions that delay or otherwise hinder new product introductions or that impact currently available products;
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new technologies, or improved products by competitors, may limit or reduce adoption and use of our products;
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clinical results associated with our products may not be deemed sufficient by us or applicable regulatory authorities to support the approval or commercial use of such products, or may not be sufficiently robust to drive widespread adoption or use;
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adverse regulatory or other governmental statements, findings or reports regarding our products, specifically, our EVAR or EVAS technology and products may adversely affect the regulatory status and market for our products generally; and
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negative publicity about, or actual or perceived problems with our products or with EVAR or EVAS devices and technologies generally, could discourage physician and hospital adoption or use of our products.
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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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major public health issues such as the outbreak of a pandemic or epidemic (such as Sudden Acute Respiratory Syndrome, Avian Influenza, H7N9 virus, the Ebola virus, or COVID-19), which could cause disruptions to our commercial operations or supply chain, or the commercial operations and supply chain of our customers, manufacturers, partners and other third-party collaborators;
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difficulties in enforcing or defending intellectual property rights;
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pricing pressure that that may require us to curtail or terminate operations in certain jurisdictions;
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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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rulings, findings, reports, recommendations or guidance from governmental or industry entities that are adverse to our products or to EVAR/EVAS products and technologies generally;
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the imposition of additional United States and foreign governmental controls or regulations;
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political, economic and social instability;
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disruptions caused by regional natural disasters, such as hurricanes, landslides, floods, earthquakes or other similar events,
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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 travel within or across certain jurisdictions;
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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 enforcing agreements and collecting receivables in certain jurisdictions;
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the imposition of costly and lengthy new export licensing requirements or other trade restrictions; and
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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.
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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, do not enroll at the rate we expect, or do not 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 rate we expect;
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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 take actions that 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, near and/or long-term safety or efficacy of our products;
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the study design is inadequate to demonstrate safety and efficacy of our products; 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 or quality requirements, or to comply with our specifications;
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failure of our suppliers to timely notify us of changes to the components they supply;
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contractual or other disputes with any such supplier, including with respect to compliance with product supply and/or payment terms;
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change of ownership of a supplier through acquisition or sale of a business
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any strike or work stoppage;
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disruptions in shipping;
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manufacturing limitations or other restrictions on availability or use of raw materials or components necessary for the development, testing, manufacture or sale of our products;
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a natural disaster or extraordinary event caused by fire, flood, earthquakes, environmental accidents or health epidemics; 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 or maintain existing product approvals.
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the results of our commercialization efforts for our existing and future products;
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the revenue 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 and other intellectual property;
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the costs of defending or responding to any litigation or investigations initiated by third parties, including intellectual property and securities litigation;
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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 patients’ 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 pre-clinical 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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develop an effective and regulatory-compliant, dedicated marketing and distribution network.
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FDA Regulations (Title 21 CFR);
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EU 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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•
|
Other international regulatory approval requirements;
|
•
|
Medical Device Single Audit Program (“MDSAP”);
|
•
|
Medical Device QMS Requirements (21 CFR 820, ISO 13485:2003, EN ISO 13485:2012, ISO 13485:2016, and other similar international regulations);
|
•
|
Occupational Safety and Health Administration requirements; and
|
•
|
CDHS requirements.
|
•
|
Up to the entire $25 million of 5.00% Mandatory Notes and $42.02 million of 5.00% Voluntary Notes are potentially convertible into our common stock upon satisfaction of certain conditions, including commencement of the applicable conversion period, achievement of minimum stock price thresholds, and compliance with ownership “blockers” (which are maximum ownership amounts that certain investors can hold at any one time expressed as a percentage of the Company’s total outstanding shares of common stock).
|
•
|
Up to the entire $11.1 million 2020 Exchange Notes are potentially convertible into our common stock upon satisfaction of certain conditions, including commencement of the applicable conversion period, achievement of minimum stock price thresholds, and compliance with ownership “blockers” (which are maximum ownership amounts that certain investors can hold at any one time expressed as a percentage of the Company’s total outstanding shares of common stock).
|
•
|
Approximately $100.7 million of the $160.0 million of indebtedness to Deerfield under the Deerfield Agreements are potentially convertible into shares of the Company’s common stock or Series DF-1 Preferred Stock (which is convertible into shares of common stock at any time, subject to ownership blockers), either at Deerfield’s election, or on a mandatory basis (subject to satisfaction of certain conditions precedent and compliance with ownership blockers).
|
•
|
actual or anticipated fluctuations in our financial and operating results from period to period;
|
•
|
our actual or perceived need for additional capital to fund our operations and future debt repayment obligations, and perceptions about the potential dilutive impact of common stock issued pursuant to conversion of portions of our senior convertible notes and Deerfield term loan, and future financing or restructuring transactions;
|
•
|
regulatory approval of our products or the products of our competitors, the loss of regulatory approvals or clearances, or the failure to obtain regulatory approvals or clearances in a timely manner or at all;
|
•
|
perceptions regarding the intentions of Deerfield with respect to the exercise of its warrants;
|
•
|
perceptions regarding our ability to comply with our financial covenants under the Deerfield Agreements;
|
•
|
perceptions about our financial stability generally, and relative to our competitors, including our ability to sustain our business operations, execute on our strategic plans and achieve profitability;
|
•
|
market acceptance of our products;
|
•
|
introduction of proposed products, technologies or treatment techniques by us or our competitors;
|
•
|
announcements of significant contracts, acquisitions or divestitures by us or our competitors;
|
•
|
product recalls involving our products or the products of our competitors;
|
•
|
perceptions regarding the effectiveness of our product quality systems;
|
•
|
speculative trading practices of market participants;
|
•
|
issuance of securities analysts’ reports or recommendations;
|
•
|
the failure of our operating results to meet expectations of securities analysts and investors, or to be consistent with our financial guidance;
|
•
|
threatened or actual litigation, government investigations or enforcement actions;
|
•
|
changes in healthcare laws or policies in the United States or other countries in which we conduct business; and
|
•
|
general political or economic conditions and other factors unrelated to our operating performance.
|
•
|
our ability to increase sales from our current products, and to commercialize and sell our future products;
|
•
|
introduction of proposed products, technologies or treatment techniques by us or our competitors;
|
•
|
the number and mix of our products sold in each quarter;
|
•
|
changes in our pricing policies or in the pricing policies of our competitors or suppliers;
|
•
|
changes in third party payors’ reimbursement policies;
|
•
|
our ability to maintain and motivate our sales force;
|
•
|
our ability to manufacture products that meet quality and regulatory requirements;
|
•
|
results of clinical research and trials on our existing and future products;
|
•
|
the timing and expense associated with obtaining and maintaining regulatory approval of our products;
|
•
|
product recalls involving our products or the products of our competitors;
|
•
|
the timing of revenue and expense recognition associated with our product sales pursuant to applicable accounting standards.
|
•
|
authorize the issuance of preferred stock with powers, preferences and rights that may be senior to our common stock, which can be created and issued by the board of directors without prior stockholder approval;
|
•
|
provide for the adoption of a staggered board of directors whereby the board is divided into three classes each of which has a different three-year term;
|
•
|
provide that the number of directors shall be fixed by the board of directors;
|
•
|
prohibit our stockholders from filling board vacancies;
|
•
|
prohibit stockholders from calling special stockholder meetings; and
|
•
|
require advance written notice of stockholder proposals and director nominations.
|
Item 1B.
|
Unresolved Staff Comments
|
Item 2.
|
Properties
|
Item 3.
|
Legal Proceedings
|
Item 4
|
Mine Safety Disclosures
|
Item 5.
|
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
|
Item 6.
|
Selected Financial Data
|
|
Year Ended December 31,
|
||||||||||||||||||
(In thousands, except per share data)
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
Consolidated Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenue
|
$
|
143,370
|
|
|
$
|
156,473
|
|
|
$
|
181,157
|
|
|
$
|
192,925
|
|
|
$
|
153,612
|
|
Loss from operations
|
(42,549
|
)
|
|
(68,192
|
)
|
|
(41,820
|
)
|
|
(95,074
|
)
|
|
(52,913
|
)
|
|||||
Net loss
|
$
|
(64,757
|
)
|
|
$
|
(79,714
|
)
|
|
$
|
(66,400
|
)
|
|
$
|
(154,677
|
)
|
|
$
|
(50,424
|
)
|
Basic and diluted net loss per share
|
$
|
(3.84
|
)
|
|
$
|
(9.07
|
)
|
|
$
|
(7.97
|
)
|
|
$
|
(19.10
|
)
|
|
$
|
(7.45
|
)
|
Shares used in computing basic and diluted loss per share
|
16,850
|
|
|
8,790
|
|
|
8,333
|
|
|
8,098
|
|
|
6,767
|
|
|||||
|
|
||||||||||||||||||
|
December 31,
|
||||||||||||||||||
(In thousands)
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Total assets
|
307,164
|
|
|
293,070
|
|
|
365,047
|
|
|
359,684
|
|
|
331,050
|
|
|||||
Debt
|
172,060
|
|
|
198,078
|
|
|
208,253
|
|
|
177,178
|
|
|
167,748
|
|
|||||
Total liabilities
|
243,308
|
|
|
253,424
|
|
|
289,985
|
|
|
246,891
|
|
|
227,743
|
|
|||||
Total stockholders’ equity
|
63,856
|
|
|
39,646
|
|
|
75,062
|
|
|
112,793
|
|
|
103,307
|
|
Item 7.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
•
|
A contract has been identified with the customer;
|
•
|
The performance obligations have been identified;
|
•
|
The transaction price has been determined and allocated to the respective performance obligations; and
|
•
|
The performance obligations have been satisfied.
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|||||||||||||||
Revenue
|
$
|
143,370
|
|
|
100.0
|
%
|
|
$
|
156,473
|
|
|
100.0
|
%
|
|
$
|
181,157
|
|
|
100.0
|
%
|
Cost of goods sold
|
52,284
|
|
|
36.5
|
%
|
|
64,550
|
|
|
41.3
|
%
|
|
59,828
|
|
|
33.0
|
%
|
|||
Gross profit
|
91,086
|
|
|
63.5
|
%
|
|
91,923
|
|
|
58.7
|
%
|
|
121,329
|
|
|
67.0
|
%
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Research and development
|
18,104
|
|
|
12.6
|
%
|
|
20,793
|
|
|
13.3
|
%
|
|
21,019
|
|
|
11.6
|
%
|
|||
Clinical and regulatory affairs
|
14,036
|
|
|
9.8
|
%
|
|
13,851
|
|
|
8.9
|
%
|
|
12,952
|
|
|
7.1
|
%
|
|||
Marketing and sales
|
64,673
|
|
|
45.1
|
%
|
|
76,855
|
|
|
49.1
|
%
|
|
92,400
|
|
|
51.0
|
%
|
|||
General and administrative
|
35,984
|
|
|
25.1
|
%
|
|
43,477
|
|
|
27.8
|
%
|
|
35,301
|
|
|
19.5
|
%
|
|||
Restructuring costs
|
838
|
|
|
0.6
|
%
|
|
3,270
|
|
|
2.1
|
%
|
|
1,477
|
|
|
0.8
|
%
|
|||
Contract termination, product withdrawal and business acquisition expenses
|
—
|
|
|
—
|
%
|
|
1,869
|
|
|
1.2
|
%
|
|
—
|
|
|
—
|
%
|
|||
Total operating expenses
|
133,635
|
|
|
93.2
|
%
|
|
160,115
|
|
|
102.3
|
%
|
|
163,149
|
|
|
90.1
|
%
|
|||
Loss from operations
|
(42,549
|
)
|
|
(29.7
|
)%
|
|
(68,192
|
)
|
|
(43.6
|
)%
|
|
(41,820
|
)
|
|
(23.1
|
)%
|
|||
Total other expense, net
|
(26,933
|
)
|
|
(18.8
|
)%
|
|
(11,238
|
)
|
|
(7.2
|
)%
|
|
(25,039
|
)
|
|
(13.8
|
)%
|
|||
Net loss before income taxes
|
(69,482
|
)
|
|
(48.5
|
)%
|
|
(79,430
|
)
|
|
(50.8
|
)%
|
|
(66,859
|
)
|
|
(36.9
|
)%
|
|||
Income tax (expense) benefit
|
4,725
|
|
|
3.3
|
%
|
|
(284
|
)
|
|
(0.2
|
)%
|
|
459
|
|
|
0.3
|
%
|
|||
Net loss
|
$
|
(64,757
|
)
|
|
(45.2
|
)%
|
|
$
|
(79,714
|
)
|
|
(50.9
|
)%
|
|
$
|
(66,400
|
)
|
|
(36.7
|
)%
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
(in thousands, except percentages)
|
2019
|
|
2018
|
|
Variance
|
|
Percent Change
|
|||||||
Revenue
|
$
|
143,370
|
|
|
$
|
156,473
|
|
|
$
|
(13,103
|
)
|
|
(8.4
|
)%
|
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
(in thousands, except percentages)
|
|
2019
|
|
2018
|
|
Variance
|
|
Percent Change
|
|||||||
Cost of goods sold
|
|
$
|
52,284
|
|
|
$
|
64,550
|
|
|
$
|
(12,266
|
)
|
|
(19.0
|
)%
|
Gross profit
|
|
91,086
|
|
|
91,923
|
|
|
(837
|
)
|
|
(0.9
|
)%
|
|||
Gross margin percentage (gross profit as a percent of revenue)
|
|
63.5
|
%
|
|
58.7
|
%
|
|
4.8
|
%
|
|
|
|
|
Year Ended December 31,
|
|
|
|
|
|||||||||
(in thousands, except percentages)
|
|
2019
|
|
2018
|
|
Variance
|
|
Percent Change
|
|||||||
Research and development
|
|
$
|
18,104
|
|
|
$
|
20,793
|
|
|
$
|
(2,689
|
)
|
|
(12.9
|
)%
|
Clinical and regulatory affairs
|
|
14,036
|
|
|
13,851
|
|
|
185
|
|
|
1.3
|
%
|
|||
Marketing and sales
|
|
64,673
|
|
|
76,855
|
|
|
(12,182
|
)
|
|
(15.9
|
)%
|
|||
General and administrative
|
|
35,984
|
|
|
43,477
|
|
|
(7,493
|
)
|
|
(17.2
|
)%
|
|||
Restructuring costs
|
|
838
|
|
|
3,270
|
|
|
(2,432
|
)
|
|
(74.4
|
)%
|
|||
Contract termination, product withdrawal and business acquisition expenses
|
|
—
|
|
|
1,869
|
|
|
(1,869
|
)
|
|
(100.0
|
)%
|
|
|
Year Ended December 31,
|
|
|
|
|
||||||||
(in thousands, except percentages)
|
|
2019
|
|
2018
|
|
Variance
|
|
Percent Change
|
||||||
Other expense, net
|
|
$
|
(26,933
|
)
|
|
$
|
(11,238
|
)
|
|
$
|
(15,695
|
)
|
|
>100%
|
|
|
Year Ended December 31,
|
|
|
|
|
||||||||
(in thousands, except percentages)
|
|
2019
|
|
2018
|
|
Variance
|
|
Percent Change
|
||||||
Income tax expense (benefit)
|
|
$
|
4,725
|
|
|
$
|
(284
|
)
|
|
$
|
5,009
|
|
|
>100%
|
|
December 31,
|
||||||||||
(dollars in thousands)
|
2019
|
|
2018
|
|
2017
|
||||||
Cash and cash equivalents
|
$
|
41,560
|
|
|
$
|
23,531
|
|
|
$
|
57,991
|
|
Accounts receivable, net
|
$
|
22,392
|
|
|
$
|
20,651
|
|
|
$
|
32,294
|
|
Total current assets
|
$
|
93,703
|
|
|
$
|
78,931
|
|
|
$
|
143,134
|
|
Total current liabilities
|
$
|
55,793
|
|
|
$
|
38,927
|
|
|
$
|
60,630
|
|
Working capital surplus
|
$
|
37,910
|
|
|
$
|
40,004
|
|
|
$
|
82,504
|
|
Current ratio
|
1.7
|
|
|
2.0
|
|
|
2.4
|
|
|||
Days sales outstanding
|
58
|
|
|
55
|
|
|
68
|
|
|||
Inventory turnover
|
1.8
|
|
|
1.7
|
|
|
1.4
|
|
•
|
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
|
||||||||||||||||||||||||
(in thousands)
|
Total
|
|
2020
|
|
2021
|
|
2022
|
|
2023
|
|
2024
|
|
Thereafter
|
||||||||||||||
Long-term debt obligations
|
$
|
281,834
|
|
|
$11,245
|
|
$22,399
|
|
$82,857
|
|
$103,314
|
|
$62,019
|
|
$
|
—
|
|
||||||||||
Interest on debt obligations
|
40,432
|
|
|
12,260
|
|
|
11,726
|
|
|
9,441
|
|
|
5,429
|
|
|
1,576
|
|
|
—
|
|
|||||||
Operating lease obligations
|
30,031
|
|
|
3,831
|
|
|
3,943
|
|
|
3,994
|
|
|
3,016
|
|
|
2,909
|
|
|
12,338
|
|
|||||||
Purchase commitments
|
1,676
|
|
|
838
|
|
|
838
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Total
|
$
|
353,973
|
|
|
$
|
28,174
|
|
|
$
|
38,906
|
|
|
$
|
96,292
|
|
|
$
|
111,759
|
|
|
$
|
66,504
|
|
|
$
|
12,338
|
|
Item 7A.
|
Quantitative and Qualitative Disclosures About Market Risk
|
Item 8.
|
Financial Statements and Selected Supplementary Data
|
Item
|
|
Page
|
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
|
|
December 31,
|
||||||
|
|
2019
|
|
2018
|
||||
ASSETS
|
|
|
|
|
||||
Current assets:
|
|
|
|
|
||||
Cash and cash equivalents
|
|
$
|
41,560
|
|
|
$
|
23,531
|
|
Restricted cash
|
|
1,200
|
|
|
1,200
|
|
||
Accounts receivable, net of allowance for doubtful accounts of $1,317 and $802, respectively
|
|
22,392
|
|
|
20,651
|
|
||
Other receivables
|
|
282
|
|
|
329
|
|
||
Inventories
|
|
26,405
|
|
|
30,399
|
|
||
Prepaid expenses and other current assets
|
|
1,864
|
|
|
2,821
|
|
||
Total current assets
|
|
93,703
|
|
|
78,931
|
|
||
Property and equipment, net
|
|
13,152
|
|
|
16,033
|
|
||
Goodwill
|
|
120,814
|
|
|
120,848
|
|
||
Other intangible assets, net
|
|
72,603
|
|
|
76,163
|
|
||
Deposits and other assets
|
|
1,124
|
|
|
1,095
|
|
||
Operating lease right-of-use assets
|
|
5,768
|
|
|
—
|
|
||
Total assets
|
|
$
|
307,164
|
|
|
$
|
293,070
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
||||
Current liabilities:
|
|
|
|
|
||||
Accounts payable
|
|
$
|
14,024
|
|
|
$
|
10,986
|
|
Accrued payroll
|
|
18,232
|
|
|
14,627
|
|
||
Accrued expenses and other current liabilities
|
|
12,931
|
|
|
13,314
|
|
||
Current portion of debt
|
|
10,606
|
|
|
—
|
|
||
Total current liabilities
|
|
55,793
|
|
|
38,927
|
|
||
Deferred income taxes
|
|
150
|
|
|
150
|
|
||
Deferred rent
|
|
—
|
|
|
8,065
|
|
||
Operating lease liabilities
|
|
11,621
|
|
|
—
|
|
||
Derivative liabilities
|
|
940
|
|
|
4,012
|
|
||
Other liabilities
|
|
2,244
|
|
|
1,992
|
|
||
Contingently issuable common stock
|
|
500
|
|
|
2,200
|
|
||
Debt
|
|
172,060
|
|
|
198,078
|
|
||
Total liabilities
|
|
243,308
|
|
|
253,424
|
|
||
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, 170,000,000 shares authorized, 18,190,054 and 10,387,926 shares issued, respectively, 18,098,464 and 10,345,367 shares outstanding, respectively
|
|
18
|
|
|
10
|
|
||
Treasury stock, at cost, 91,590 and 42,559 shares, respectively
|
|
(4,235
|
)
|
|
(4,026
|
)
|
||
Additional paid-in capital
|
|
730,729
|
|
|
640,789
|
|
||
Accumulated deficit
|
|
(664,472
|
)
|
|
(599,715
|
)
|
||
Accumulated other comprehensive income
|
|
1,816
|
|
|
2,588
|
|
||
Total stockholders’ equity
|
|
63,856
|
|
|
39,646
|
|
||
Total liabilities and stockholders’ equity
|
|
$
|
307,164
|
|
|
$
|
293,070
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Revenue
|
$
|
143,370
|
|
|
$
|
156,473
|
|
|
$
|
181,157
|
|
Cost of goods sold
|
52,284
|
|
|
64,550
|
|
|
59,828
|
|
|||
Gross profit
|
91,086
|
|
|
91,923
|
|
|
121,329
|
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
18,104
|
|
|
20,793
|
|
|
21,019
|
|
|||
Clinical and regulatory affairs
|
14,036
|
|
|
13,851
|
|
|
12,952
|
|
|||
Marketing and sales
|
64,673
|
|
|
76,855
|
|
|
92,400
|
|
|||
General and administrative
|
35,984
|
|
|
43,477
|
|
|
35,301
|
|
|||
Restructuring costs
|
838
|
|
|
3,270
|
|
|
1,477
|
|
|||
Contract termination, product withdrawal and business acquisition expenses
|
—
|
|
|
1,869
|
|
|
—
|
|
|||
Total operating expenses
|
133,635
|
|
|
160,115
|
|
|
163,149
|
|
|||
Loss from operations
|
(42,549
|
)
|
|
(68,192
|
)
|
|
(41,820
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Interest income
|
6
|
|
|
10
|
|
|
83
|
|
|||
Interest expense
|
(34,973
|
)
|
|
(27,658
|
)
|
|
(22,064
|
)
|
|||
Change in fair value of contingent consideration related to acquisition
|
1,700
|
|
|
7,100
|
|
|
2,900
|
|
|||
Loss on debt extinguishment
|
(11,756
|
)
|
|
(2,270
|
)
|
|
(6,512
|
)
|
|||
Change in fair value of derivative liabilities
|
17,713
|
|
|
12,097
|
|
|
—
|
|
|||
Other (expense) income, net
|
377
|
|
|
(517
|
)
|
|
554
|
|
|||
Total other expense, net
|
(26,933
|
)
|
|
(11,238
|
)
|
|
(25,039
|
)
|
|||
Net loss before income taxes
|
(69,482
|
)
|
|
(79,430
|
)
|
|
(66,859
|
)
|
|||
Income tax (expense) benefit
|
4,725
|
|
|
(284
|
)
|
|
459
|
|
|||
Net loss
|
$
|
(64,757
|
)
|
|
$
|
(79,714
|
)
|
|
$
|
(66,400
|
)
|
|
|
|
|
|
|
||||||
Comprehensive loss, net of taxes:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(64,757
|
)
|
|
$
|
(79,714
|
)
|
|
$
|
(66,400
|
)
|
Other comprehensive (loss) income on foreign currency translation
|
(772
|
)
|
|
(747
|
)
|
|
1,847
|
|
|||
Comprehensive loss
|
$
|
(65,529
|
)
|
|
$
|
(80,461
|
)
|
|
$
|
(64,553
|
)
|
|
|
|
|
|
|
|
|
|
|||
Basic and diluted net loss per share
|
$
|
(3.84
|
)
|
|
$
|
(9.07
|
)
|
|
$
|
(7.97
|
)
|
Shares used in computing basic and diluted loss per share
|
16,850
|
|
|
8,790
|
|
|
8,333
|
|
|
Common Stock
|
|
Additional
Paid-In Capital |
|
Accumulated
Deficit |
|
Treasury
Stock |
|
Accumulated Other Comprehensive Income (Loss)
|
|
Total Stockholders’
Equity |
|||||||||||||||
|
Issued Shares
|
|
Par Value
|
|
|
|
|
|
||||||||||||||||||
Balance at December 31, 2016
|
8,299
|
|
|
$
|
8
|
|
|
$
|
567,840
|
|
|
$
|
(453,601
|
)
|
|
$
|
(2,942
|
)
|
|
$
|
1,488
|
|
|
$
|
112,793
|
|
Exercise of common stock options
|
13
|
|
|
—
|
|
|
546
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
546
|
|
||||||
Employee stock purchase plan
|
45
|
|
|
—
|
|
|
2,519
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,519
|
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
8,538
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
8,538
|
|
||||||
Issuance of restricted stock
|
29
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Restricted stock expense
|
—
|
|
|
—
|
|
|
3,106
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,106
|
|
||||||
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 income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,847
|
|
|
1,847
|
|
||||||
Balance at December 31, 2017
|
8,386
|
|
|
8
|
|
|
594,662
|
|
|
(520,001
|
)
|
|
(2,942
|
)
|
|
3,335
|
|
|
75,062
|
|
||||||
Exercise of common stock options, net of shares withheld to cover exercise price
|
44
|
|
|
—
|
|
|
1,586
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,586
|
|
||||||
Employee stock purchase plan
|
61
|
|
|
—
|
|
|
1,346
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,346
|
|
||||||
Issuance of common stock
|
1,841
|
|
|
2
|
|
|
21,827
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
21,829
|
|
||||||
Treasury stock purchased
|
21
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,084
|
)
|
|
—
|
|
|
(1,084
|
)
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
8,404
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
8,404
|
|
||||||
Issuance of restricted stock
|
35
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Restricted stock expense
|
—
|
|
|
—
|
|
|
2,626
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,626
|
|
||||||
Deerfield warrants
|
—
|
|
|
—
|
|
|
10,396
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,396
|
|
||||||
Debt issuance costs allocated to equity
|
—
|
|
|
—
|
|
|
(58
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(58
|
)
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(79,714
|
)
|
|
—
|
|
|
—
|
|
|
(79,714
|
)
|
||||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(747
|
)
|
|
(747
|
)
|
||||||
Balance at December 31, 2018
|
10,388
|
|
|
$
|
10
|
|
|
$
|
640,789
|
|
|
$
|
(599,715
|
)
|
|
$
|
(4,026
|
)
|
|
$
|
2,588
|
|
|
$
|
39,646
|
|
Employee stock purchase plan
|
107
|
|
|
—
|
|
|
344
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
344
|
|
||||||
Issuance of common stock
|
6,422
|
|
|
6
|
|
|
42,279
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
42,285
|
|
||||||
Treasury stock purchased
|
49
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(209
|
)
|
|
—
|
|
|
(209
|
)
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
5,986
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,986
|
|
||||||
Issuance of restricted stock
|
206
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
||||||
Restricted stock expense
|
—
|
|
|
—
|
|
|
4,862
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,862
|
|
||||||
Equity conversion option
|
—
|
|
|
—
|
|
|
19,321
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
19,321
|
|
||||||
Deerfield warrants
|
—
|
|
|
—
|
|
|
4,854
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,854
|
|
||||||
Prepaid warrants
|
—
|
|
|
—
|
|
|
9,700
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9,700
|
|
||||||
Debt issuance costs allocated to equity
|
—
|
|
|
—
|
|
|
(762
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(762
|
)
|
||||||
Shares issued upon conversion of debt
|
1,018
|
|
|
1
|
|
|
3,356
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,357
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(64,757
|
)
|
|
—
|
|
|
—
|
|
|
(64,757
|
)
|
||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(772
|
)
|
|
(772
|
)
|
||||||
Balance at December 31, 2019
|
18,190
|
|
|
$
|
18
|
|
|
$
|
730,729
|
|
|
$
|
(664,472
|
)
|
|
$
|
(4,235
|
)
|
|
$
|
1,816
|
|
|
$
|
63,856
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(64,757
|
)
|
|
$
|
(79,714
|
)
|
|
$
|
(66,400
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Deferred income taxes
|
(4,950
|
)
|
|
(57
|
)
|
|
(696
|
)
|
|||
Bad debt expense
|
534
|
|
|
552
|
|
|
(235
|
)
|
|||
Depreciation and amortization
|
6,890
|
|
|
7,982
|
|
|
9,111
|
|
|||
Stock-based compensation
|
10,849
|
|
|
11,030
|
|
|
11,644
|
|
|||
Change in fair value of derivative liabilities
|
(17,713
|
)
|
|
(12,097
|
)
|
|
—
|
|
|||
Change in fair value of contingent consideration related to acquisition
|
(1,700
|
)
|
|
(7,100
|
)
|
|
(2,900
|
)
|
|||
Accretion of interest and amortization of deferred financing costs
|
14,264
|
|
|
11,801
|
|
|
10,165
|
|
|||
Payable in kind interest expense on term loan facility
|
7,978
|
|
|
3,084
|
|
|
—
|
|
|||
Loss on debt extinguishment
|
11,756
|
|
|
2,270
|
|
|
6,512
|
|
|||
Loss on disposal of assets
|
—
|
|
|
64
|
|
|
—
|
|
|||
Non-cash foreign exchange loss (gain)
|
(330
|
)
|
|
711
|
|
|
(678
|
)
|
|||
Non-cash lease expense
|
260
|
|
|
—
|
|
|
—
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable and other receivables
|
(2,180
|
)
|
|
10,913
|
|
|
4,771
|
|
|||
Inventories
|
3,623
|
|
|
13,805
|
|
|
(3,035
|
)
|
|||
Prepaid expenses and other current assets
|
1,121
|
|
|
1,693
|
|
|
(1,034
|
)
|
|||
Accounts payable
|
3,107
|
|
|
(1,350
|
)
|
|
(1,826
|
)
|
|||
Accrued payroll
|
3,624
|
|
|
(350
|
)
|
|
(5,176
|
)
|
|||
Accrued expenses and other liabilities
|
(1,946
|
)
|
|
(1,850
|
)
|
|
4,374
|
|
|||
Net cash used in operating activities
|
(29,570
|
)
|
|
(38,613
|
)
|
|
(35,403
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
||||||
Maturities of marketable securities
|
—
|
|
|
—
|
|
|
21,000
|
|
|||
Purchases of property and equipment
|
(455
|
)
|
|
(602
|
)
|
|
(1,170
|
)
|
|||
Net cash (used in) provided by investing activities
|
(455
|
)
|
|
(602
|
)
|
|
19,830
|
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
||||||
Cash paid for debt extinguishment
|
—
|
|
|
(1,310
|
)
|
|
(2,515
|
)
|
|||
Net (payments) proceeds from revolving line of credit
|
—
|
|
|
(21
|
)
|
|
21
|
|
|||
Deferred financing costs
|
(3,977
|
)
|
|
(391
|
)
|
|
(6,755
|
)
|
|||
Proceeds from sale of common stock under employee stock purchase plan
|
346
|
|
|
1,346
|
|
|
2,519
|
|
|||
Proceeds from common stock offering and pre-paid warrants, net of expenses paid
|
51,985
|
|
|
20,000
|
|
|
—
|
|
|||
Proceeds from the sale of at-the-market shares
|
—
|
|
|
1,829
|
|
|
—
|
|
|||
Proceeds from exercise of stock options
|
—
|
|
|
892
|
|
|
546
|
|
|||
Proceeds from issuance of debt
|
—
|
|
|
—
|
|
|
120,000
|
|
|||
Repayment of debt
|
—
|
|
|
(18,278
|
)
|
|
(66,613
|
)
|
|||
Minimum tax withholding paid on behalf of employees for stock-based compensation
|
(209
|
)
|
|
(390
|
)
|
|
—
|
|
|||
Net cash provided by financing activities
|
48,145
|
|
|
3,677
|
|
|
47,203
|
|
|||
Effect of exchange rate changes on cash, cash equivalents and restricted cash
|
(91
|
)
|
|
(330
|
)
|
|
848
|
|
|||
Net (decrease) increase in cash, cash equivalents and restricted cash
|
18,029
|
|
|
(35,868
|
)
|
|
32,478
|
|
|||
Cash, cash equivalents and restricted cash, beginning of year
|
24,731
|
|
|
60,599
|
|
|
28,121
|
|
|||
Cash, cash equivalents and restricted cash, end of year
|
$
|
42,760
|
|
|
$
|
24,731
|
|
|
$
|
60,599
|
|
Reconciliation of cash, cash equivalents and restricted cash to the Consolidated Balance Sheets:
|
|
|
|
|
|
||||||
Cash and cash equivalents
|
$
|
41,560
|
|
|
$
|
23,531
|
|
|
$
|
57,991
|
|
Restricted cash
|
1,200
|
|
|
1,200
|
|
|
2,608
|
|
|||
Total cash, cash equivalents and restricted cash
|
$
|
42,760
|
|
|
$
|
24,731
|
|
|
$
|
60,599
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
10,321
|
|
|
$
|
12,499
|
|
|
$
|
9,836
|
|
Cash paid for income taxes
|
156
|
|
|
272
|
|
|
681
|
|
|||
Cash paid for amounts included in the measurement of operating lease liabilities
|
3,402
|
|
|
—
|
|
|
—
|
|
|||
Non-cash investing and financing activities:
|
|
|
|
|
|
||||||
Acquisition of property and equipment included in accounts payable
|
102
|
|
|
53
|
|
|
—
|
|
|||
Fair value of embedded derivative issued in connection with loan agreements (Note 6)
|
20,447
|
|
|
15,655
|
|
|
—
|
|
|||
Conversion of debt to equity
|
3,289
|
|
|
—
|
|
|
—
|
|
|||
Fair value of warrants issued in connection with loan agreements (Note 6)
|
—
|
|
|
10,396
|
|
|
14,704
|
|
|||
Conversion of refund to note payable (Note 6)
|
—
|
|
|
4,281
|
|
|
—
|
|
Property Class
|
|
Useful Life
|
Office furniture
|
|
7 years
|
Computer hardware
|
|
3 years
|
Computer software
|
|
3-8 years
|
Production equipment and molds
|
|
3-7 years
|
Leasehold improvements
|
|
Shorter of expected useful life or remaining term of lease
|
•
|
Level 1 — Quoted prices in active markets for identical assets or liabilities.
|
•
|
Level 2 — Observable inputs other than Level 1 prices such as: quoted prices for similar assets or liabilities; quoted prices in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated by observable market data for substantially the full term of the assets or liabilities.
|
•
|
Level 3 — Unobservable inputs to the valuation methodology that are significant to the measurement of fair value of assets or liabilities.
|
•
|
A contract has been identified with the customer;
|
•
|
The performance obligations have been identified;
|
•
|
The transaction price has been determined and allocated to the respective performance obligations; and
|
•
|
The performance obligations have been satisfied.
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Production equipment, molds and office furniture
|
$
|
10,844
|
|
|
$
|
11,854
|
|
Computer hardware and software
|
7,897
|
|
|
8,235
|
|
||
Leasehold improvements
|
15,594
|
|
|
15,535
|
|
||
Construction in progress (software and related implementation, production equipment and leasehold improvements)
|
795
|
|
|
993
|
|
||
Property and equipment, at cost
|
35,130
|
|
|
36,617
|
|
||
Accumulated depreciation
|
(21,978
|
)
|
|
(20,584
|
)
|
||
Property and equipment, net
|
$
|
13,152
|
|
|
$
|
16,033
|
|
Balance at December 31, 2018
|
$
|
120,848
|
|
Foreign currency translation adjustment
|
(34
|
)
|
|
Balance at December 31, 2019
|
120,814
|
|
|
|
|
December 31, 2019
|
|
December 31, 2018
|
||||||||||||||||||||
|
Estimated Useful Life
(in years)
|
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net Carrying Amount
|
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net Carrying Amount
|
||||||||||||
Indefinite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Trademarks and trade names
|
N/A
|
|
$
|
2,708
|
|
|
N/A
|
|
$
|
2,708
|
|
|
$
|
2,708
|
|
|
N/A
|
|
$
|
2,708
|
|
||||
In-process research and development
|
N/A
|
|
11,200
|
|
|
N/A
|
|
11,200
|
|
|
11,200
|
|
|
N/A
|
|
11,200
|
|
||||||||
Total indefinite-lived intangible assets
|
|
|
13,908
|
|
|
|
|
13,908
|
|
|
13,908
|
|
|
|
|
13,908
|
|
||||||||
Finite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Developed technology
|
11-24
|
|
67,600
|
|
|
$
|
(13,467
|
)
|
|
54,133
|
|
|
67,600
|
|
|
$
|
(10,657
|
)
|
|
56,943
|
|
||||
Customer relationships
|
10
|
|
7,500
|
|
|
(2,938
|
)
|
|
4,562
|
|
|
7,500
|
|
|
(2,188
|
)
|
|
5,312
|
|
||||||
Total finite-lived intangible assets
|
|
|
75,100
|
|
|
(16,405
|
)
|
|
58,695
|
|
|
75,100
|
|
|
(12,845
|
)
|
|
62,255
|
|
||||||
Other intangible assets, net
|
|
|
$
|
89,008
|
|
|
$
|
(16,405
|
)
|
|
$
|
72,603
|
|
|
$
|
89,008
|
|
|
$
|
(12,845
|
)
|
|
$
|
76,163
|
|
2020
|
$
|
3,185
|
|
2021
|
3,276
|
|
|
2022
|
3,319
|
|
|
2023
|
3,378
|
|
|
2024
|
3,497
|
|
|
Thereafter
|
42,040
|
|
|
Total
|
$
|
58,695
|
|
|
|
December 31, 2019
|
|
December 31, 2018
|
||||||||||||||||||||||||||||
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||||||||||
Financial liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Contingently issuable common stock
|
(a)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
500
|
|
|
$
|
500
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,200
|
|
|
$
|
2,200
|
|
Derivative liabilities
|
(b)
|
—
|
|
|
—
|
|
|
940
|
|
|
940
|
|
|
—
|
|
|
—
|
|
|
4,012
|
|
|
4,012
|
|
||||||||
Total financial liabilities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,440
|
|
|
$
|
1,440
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,212
|
|
|
$
|
6,212
|
|
(a)
|
Included in other liabilities in the Consolidated Balance Sheets. See Note 9 for additional details.
|
(b)
|
See Note 6 for additional details.
|
|
Contingently issuable common stock
(a) |
|
Derivative liabilities
(b) |
||||
Balance at December 31, 2018
|
$
|
2,200
|
|
|
$
|
4,012
|
|
Additions
|
—
|
|
|
14,641
|
|
||
Fair value adjustment
|
(1,700
|
)
|
|
(17,713
|
)
|
||
Balance at December 31, 2019
|
$
|
500
|
|
|
$
|
940
|
|
(a)
|
See Note 9 for additional details.
|
(b)
|
See Note 6 for additional details.
|
|
December 31, 2019
|
|
December 31, 2018
|
||||||||||||
|
Carrying value
|
|
Fair value
|
|
Carrying value
|
|
Fair value
|
||||||||
Term loan facility
|
$
|
141,273
|
|
|
$
|
131,892
|
|
|
$
|
117,880
|
|
|
$
|
116,916
|
|
Convertible notes
|
26,506
|
|
|
24,548
|
|
|
75,917
|
|
|
50,489
|
|
||||
Other debt
|
4,281
|
|
|
1,416
|
|
|
4,281
|
|
|
1,221
|
|
||||
|
$
|
172,060
|
|
|
$
|
157,856
|
|
|
$
|
198,078
|
|
|
$
|
168,626
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Stock-based compensation expense
|
$
|
131
|
|
|
$
|
1,033
|
|
|
$
|
850
|
|
Common stock purchased by Company employees
|
103,981
|
|
|
60,695
|
|
|
44,649
|
|
|||
Average purchase price per share
|
$
|
3.33
|
|
|
$
|
22.16
|
|
|
$
|
56.43
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Cost of goods sold
|
$
|
829
|
|
|
$
|
830
|
|
|
$
|
828
|
|
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
1,346
|
|
|
1,132
|
|
|
1,259
|
|
|||
Clinical and regulatory affairs
|
790
|
|
|
483
|
|
|
770
|
|
|||
Marketing and sales
|
3,100
|
|
|
3,468
|
|
|
3,796
|
|
|||
General and administrative
|
4,784
|
|
|
5,117
|
|
|
4,991
|
|
|||
Total operating expenses
|
10,020
|
|
|
10,200
|
|
|
10,816
|
|
|||
Total stock-based compensation expense
|
$
|
10,849
|
|
|
$
|
11,030
|
|
|
$
|
11,644
|
|
|
Year Ended December 31,
|
||||
|
2019
|
|
2018
|
|
2017
|
Expected life (in years)
|
5.7
|
|
5.6
|
|
5.6
|
Volatility
|
62.9%
|
|
56.5%
|
|
51.3%
|
Risk-free interest rate
|
2.3%
|
|
2.7%
|
|
1.9%
|
Dividend yield
|
—
|
|
—
|
|
—
|
Weighted average grant date fair value per share
|
$6.48
|
|
$10.66
|
|
$25.13
|
|
Number of
Shares |
|
Weighted
Average Exercise Price |
|
Weighted-
Average Remaining Contractual Life (in years) |
|
Aggregate Intrinsic Value (a)
|
|||||
Outstanding balance at December 31, 2018
|
1,315,360
|
|
|
$
|
54.20
|
|
|
|
|
|
||
Granted
|
2,039,387
|
|
|
6.48
|
|
|
|
|
|
|||
Exercised
|
—
|
|
|
—
|
|
|
|
|
|
|||
Forfeited
|
(508,630
|
)
|
|
38.86
|
|
|
|
|
|
|||
Expired
|
(504,591
|
)
|
|
81.28
|
|
|
|
|
|
|||
Outstanding balance at December 31, 2019
|
2,341,526
|
|
|
$
|
10.12
|
|
|
8.6
|
|
$
|
—
|
|
Vested and expected to vest balance at December 31, 2019
|
2,081,243
|
|
|
$
|
10.53
|
|
|
8.6
|
|
$
|
—
|
|
Exercisable balance at December 31, 2019
|
482,446
|
|
|
$
|
21.65
|
|
|
8.1
|
|
$
|
—
|
|
(a)
|
The aggregate intrinsic value of stock options as of December 31, 2019 is calculated based on the difference between the Company’s closing stock price on the last trading day of the period reported and the stock option exercise price.
|
|
|
Outstanding
|
|
Exercisable
|
||||||||||||||||||||
Range of Exercise Prices
|
|
Number of Shares
|
|
Weighted
Average Remaining Contractual Term (in years) |
|
Weighted
Average Exercise Price |
|
Number of Shares
|
|
Weighted
Average Remaining Contractual Term (in years) |
|
Weighted
Average Exercise Price |
||||||||||||
$
|
2.30
|
|
—
|
$
|
6.35
|
|
|
317,162
|
|
|
6.4
|
|
$
|
5.12
|
|
|
—
|
|
|
0.0
|
|
$
|
—
|
|
6.67
|
|
—
|
6.67
|
|
|
1,450,075
|
|
|
9.3
|
|
6.67
|
|
|
146,982
|
|
|
9.0
|
|
6.67
|
|
||||
6.76
|
|
—
|
7.45
|
|
|
290,484
|
|
|
9.0
|
|
7.29
|
|
|
214,631
|
|
|
9.0
|
|
7.43
|
|
||||
7.53
|
|
—
|
75.30
|
|
|
265,773
|
|
|
7.2
|
|
31.02
|
|
|
103,021
|
|
|
5.8
|
|
56.95
|
|
||||
77.60
|
|
—
|
175.80
|
|
|
18,032
|
|
|
2.2
|
|
112.55
|
|
|
17,812
|
|
|
2.1
|
|
112.52
|
|
||||
$
|
2.30
|
|
—
|
$
|
175.80
|
|
|
2,341,526
|
|
|
8.6
|
|
$
|
10.12
|
|
|
482,446
|
|
|
8.1
|
|
$
|
21.65
|
|
|
Number of
Shares |
|
Weighted Average
Grant Date Fair Value |
|||
Unvested as of December 31, 2018
|
422,720
|
|
|
$
|
26.15
|
|
Granted (1)
|
745,498
|
|
|
6.51
|
|
|
Forfeited
|
(41,363
|
)
|
|
31.50
|
|
|
Vested
|
(255,873
|
)
|
|
16.69
|
|
|
Unvested as of December 31, 2019
|
870,982
|
|
|
$
|
11.88
|
|
(1)
|
Shares granted in 2019 include 470,886 performance stock units that require certain performance conditions to be achieved in order to vest.
|
|
Year Ended December 31,
|
|||||||
|
2019
|
|
2018
|
|
2017
|
|||
Common stock options
|
62
|
|
|
11,276
|
|
|
52,029
|
|
Restricted stock awards
|
3,501
|
|
|
11,616
|
|
|
11,898
|
|
Restricted stock units
|
70,472
|
|
|
21,974
|
|
|
25,005
|
|
Warrants
|
1,522,002
|
|
|
—
|
|
|
—
|
|
Total
|
1,596,037
|
|
|
44,866
|
|
|
88,932
|
|
|
Year Ended December 31,
|
|||||||
|
2019
|
|
2018
|
|
2017
|
|||
Convertible notes
|
8,211,088
|
|
|
755,695
|
|
|
1,193,938
|
|
Conversion features under term loan facility
|
10,486,604
|
|
|
1,522,002
|
|
|
647,001
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Term loan facility
|
$
|
167,858
|
|
|
$
|
161,622
|
|
Convertible notes
|
73,165
|
|
|
84,500
|
|
||
Other debt
|
4,281
|
|
|
4,281
|
|
||
Debt discounts and deferred financing costs
|
(62,638
|
)
|
|
(52,325
|
)
|
||
Long-term debt, including current portion
|
182,666
|
|
|
198,078
|
|
||
Less current portion
|
(10,606
|
)
|
|
—
|
|
||
Long-term debt
|
$
|
172,060
|
|
|
$
|
198,078
|
|
|
Number of shares of common stock
|
|
Previous Exercise Price
|
|
Amended Exercise price
|
|||||
2017 Deerfield Warrants
|
647,001
|
|
|
$
|
92.30
|
|
|
$
|
6.61
|
|
2018 Deerfield Warrants
|
875,001
|
|
|
$
|
47.10
|
|
|
$
|
6.61
|
|
|
Term loan facility
|
|
Convertible notes
|
|
Other debt
|
|
Total
|
||||||||
Year ending December 31:
|
|
|
|
|
|
|
|
||||||||
2020
|
$
|
—
|
|
|
$
|
11,145
|
|
|
$
|
—
|
|
|
$
|
11,145
|
|
2021
|
20,846
|
|
|
—
|
|
|
—
|
|
|
20,846
|
|
||||
2022
|
73,506
|
|
|
—
|
|
|
—
|
|
|
73,506
|
|
||||
2023
|
73,506
|
|
|
—
|
|
|
4,281
|
|
|
77,787
|
|
||||
2024
|
—
|
|
|
62,019
|
|
|
—
|
|
|
62,019
|
|
||||
|
$
|
167,858
|
|
|
$
|
73,164
|
|
|
$
|
4,281
|
|
|
$
|
245,303
|
|
|
Year Ended December 31,
|
||||||||||||||||||||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||||||||||||||||||||||||||
|
Implant-based
|
|
Shipment-based
|
|
Total
|
|
Implant-based
|
|
Shipment-based
|
|
Total
|
|
Implant-based
|
|
Shipment-based
|
|
Total
|
||||||||||||||||||
United States
|
$
|
92,071
|
|
|
$
|
3,245
|
|
|
$
|
95,316
|
|
|
$
|
106,014
|
|
|
$
|
3,079
|
|
|
$
|
109,093
|
|
|
$
|
120,572
|
|
|
$
|
2,637
|
|
|
$
|
123,209
|
|
International
|
13,745
|
|
|
34,309
|
|
|
48,054
|
|
|
21,097
|
|
|
26,283
|
|
|
47,380
|
|
|
23,246
|
|
|
34,702
|
|
|
57,948
|
|
|||||||||
Total Revenue
|
$
|
105,816
|
|
|
$
|
37,554
|
|
|
$
|
143,370
|
|
|
$
|
127,111
|
|
|
$
|
29,362
|
|
|
$
|
156,473
|
|
|
$
|
143,818
|
|
|
$
|
37,339
|
|
|
$
|
181,157
|
|
2020
|
$
|
3,584
|
|
2021
|
3,753
|
|
|
2022
|
3,861
|
|
|
2023
|
2,950
|
|
|
2024
|
2,849
|
|
|
2025 and thereafter
|
12,338
|
|
|
Total lease payments
|
$
|
29,335
|
|
Less: Imputed Interest
|
(15,877
|
)
|
|
Present value of operating lease liabilities
|
$
|
13,458
|
|
2020
|
3,791
|
|
|
2021
|
3,819
|
|
|
2022
|
3,871
|
|
|
2023
|
2,889
|
|
|
2024
|
2,794
|
|
|
2025 and thereafter
|
12,338
|
|
|
Total lease payments
|
$
|
29,502
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
United States
|
$
|
(64,076
|
)
|
|
$
|
(70,176
|
)
|
|
$
|
(56,178
|
)
|
Foreign
|
(5,406
|
)
|
|
(9,254
|
)
|
|
(10,681
|
)
|
|||
Net loss before income taxes
|
$
|
(69,482
|
)
|
|
$
|
(79,430
|
)
|
|
$
|
(66,859
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(102
|
)
|
State
|
53
|
|
|
81
|
|
|
102
|
|
|||
Foreign
|
172
|
|
|
260
|
|
|
237
|
|
|||
Total current
|
225
|
|
|
341
|
|
|
237
|
|
|||
Deferred:
|
|
|
|
|
|
||||||
Federal
|
(4,133
|
)
|
|
(27
|
)
|
|
(699
|
)
|
|||
State
|
(819
|
)
|
|
(19
|
)
|
|
—
|
|
|||
Foreign
|
2
|
|
|
(11
|
)
|
|
3
|
|
|||
Total deferred
|
(4,950
|
)
|
|
(57
|
)
|
|
(696
|
)
|
|||
Total:
|
|
|
|
|
|
||||||
Federal
|
(4,133
|
)
|
|
(27
|
)
|
|
(801
|
)
|
|||
State
|
(766
|
)
|
|
62
|
|
|
102
|
|
|||
Foreign
|
174
|
|
|
249
|
|
|
240
|
|
|||
Income tax expense (benefit)
|
$
|
(4,725
|
)
|
|
$
|
284
|
|
|
$
|
(459
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Income tax benefit at federal statutory rate
|
$
|
(14,591
|
)
|
|
$
|
(16,680
|
)
|
|
$
|
(22,732
|
)
|
State income tax benefit, net of federal benefit
|
(1,160
|
)
|
|
(1,756
|
)
|
|
(1,114
|
)
|
|||
Meals and entertainment
|
178
|
|
|
230
|
|
|
454
|
|
|||
Research and development credits
|
(931
|
)
|
|
(1,211
|
)
|
|
(913
|
)
|
|||
Stock-based compensation
|
1,825
|
|
|
2,016
|
|
|
3,203
|
|
|||
163(l) limited interest expense
|
4,391
|
|
|
994
|
|
|
—
|
|
|||
Contingent consideration
|
(357
|
)
|
|
(1,491
|
)
|
|
(986
|
)
|
|||
Foreign tax rate differential
|
(269
|
)
|
|
(405
|
)
|
|
692
|
|
|||
Net change in valuation allowance
|
2,899
|
|
|
16,360
|
|
|
(24,976
|
)
|
|||
Return to provision
|
2,387
|
|
|
1,612
|
|
|
5,719
|
|
|||
Unrecognized tax benefits
|
466
|
|
|
605
|
|
|
457
|
|
|||
Federal tax rate change
|
—
|
|
|
—
|
|
|
39,807
|
|
|||
NOL expiration and other, net
|
437
|
|
|
10
|
|
|
(70
|
)
|
|||
Income tax expense (benefit)
|
$
|
(4,725
|
)
|
|
$
|
284
|
|
|
$
|
(459
|
)
|
|
Year Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Deferred tax assets:
|
|
|
|
|
|
||
Net operating loss carryforwards
|
$
|
114,124
|
|
|
$
|
110,130
|
|
Accrued expenses
|
3,647
|
|
|
3,757
|
|
||
Tax credits
|
13,054
|
|
|
12,540
|
|
||
Bad debt
|
240
|
|
|
104
|
|
||
Inventory
|
4,056
|
|
|
4,821
|
|
||
Capitalized research and development
|
20,161
|
|
|
17,931
|
|
||
Equity compensation
|
2,965
|
|
|
2,669
|
|
||
Operating lease liabilities
|
3,239
|
|
|
—
|
|
||
Interest expense
|
8,418
|
|
|
3,718
|
|
||
Other
|
873
|
|
|
1,174
|
|
||
Deferred tax asset
|
170,777
|
|
|
156,844
|
|
||
Valuation allowance
|
(139,855
|
)
|
|
(135,216
|
)
|
||
Total deferred tax assets
|
30,922
|
|
|
21,628
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Developed technology and trademark
|
(8,842
|
)
|
|
(8,830
|
)
|
||
Trademarks and trade names
|
(826
|
)
|
|
(765
|
)
|
||
Depreciation and amortization
|
(6,924
|
)
|
|
(8,034
|
)
|
||
Convertible debt
|
(12,878
|
)
|
|
(4,149
|
)
|
||
Operating lease right-of-use assets
|
(1,372
|
)
|
|
—
|
|
||
Other
|
(230
|
)
|
|
—
|
|
||
Total deferred tax liabilities
|
(31,072
|
)
|
|
(21,778
|
)
|
||
Net deferred tax liability
|
$
|
(150
|
)
|
|
$
|
(150
|
)
|
|
Year Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Balance at January 1
|
$
|
12,888
|
|
|
$
|
12,207
|
|
Additions for tax positions related to prior periods
|
—
|
|
|
—
|
|
||
Decreases related to prior year tax positions
|
(26
|
)
|
|
(17
|
)
|
||
Lapse of statute of limitations
|
—
|
|
|
—
|
|
||
Additions for tax positions related to current period
|
538
|
|
|
698
|
|
||
Balance at December 31
|
$
|
13,400
|
|
|
$
|
12,888
|
|
|
Revenue
|
|
Gross profit
|
|
Operating expenses
|
|
Net loss
|
|
Basic and diluted loss per share
|
||||||||||
Three Months Ended:
|
|
|
|
|
|
|
|
|
|
||||||||||
December 31, 2019
|
$
|
35,751
|
|
|
$
|
21,829
|
|
|
$
|
31,687
|
|
|
$
|
(7,830
|
)
|
|
$
|
(0.40
|
)
|
September 30, 2019
|
35,775
|
|
|
23,074
|
|
|
33,904
|
|
|
(7,765
|
)
|
|
(0.40
|
)
|
|||||
June 30, 2019
|
36,238
|
|
|
22,984
|
|
|
32,851
|
|
|
(27,134
|
)
|
|
(1.50
|
)
|
|||||
March 31, 2019
|
35,606
|
|
|
23,199
|
|
|
35,193
|
|
|
(22,028
|
)
|
|
(2.12
|
)
|
|||||
Three Months Ended:
|
|
|
|
|
|
|
|
|
|
||||||||||
December 31, 2018
|
$
|
34,693
|
|
|
$
|
11,366
|
|
|
$
|
35,062
|
|
|
$
|
(25,955
|
)
|
|
$
|
(2.67
|
)
|
September 30, 2018
|
34,756
|
|
|
22,627
|
|
|
38,546
|
|
|
(10,116
|
)
|
|
(1.20
|
)
|
|||||
June 30, 2018
|
44,740
|
|
|
29,604
|
|
|
45,110
|
|
|
(23,876
|
)
|
|
(2.80
|
)
|
|||||
March 31, 2018
|
42,284
|
|
|
28,326
|
|
|
41,397
|
|
|
(19,767
|
)
|
|
(2.40
|
)
|
|
One-time termination benefits
|
||
Accrual balance as of December 31, 2018
|
$
|
562
|
|
Restructuring charges
|
838
|
|
|
Utilization
|
(1,310
|
)
|
|
Accrual balance as of December 31, 2019
|
$
|
90
|
|
Item 9.
|
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
|
Item 9A
|
Controls and Procedures
|
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
|
(a)
|
Financial Statements and 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, 2019
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
|
$
|
802
|
|
|
$
|
534
|
|
|
$
|
—
|
|
|
$
|
(19
|
)
|
|
$
|
1,317
|
|
Year ended December 31, 2018
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
|
$
|
470
|
|
|
$
|
552
|
|
|
$
|
—
|
|
|
$
|
(220
|
)
|
|
$
|
802
|
|
Year ended December 31, 2017
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Allowance for doubtful accounts
|
|
$
|
1,037
|
|
|
$
|
(235
|
)
|
|
$
|
—
|
|
|
$
|
(332
|
)
|
|
$
|
470
|
|
(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 updated through March 5, 2019 and currently in effect) (Incorporated by reference to Exhibit 3.1 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on April 1, 2019).
|
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series DF-1 Preferred Stock (Incorporated by reference to Exhibit 3.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on February 24, 2020).
|
|
|
Amended and Restated Bylaws (as updated through June 14, 2018 and currently in effect) (Incorporated by reference to Exhibit 3.2 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on April 1, 2019).
|
|
|
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).
|
|
(2)
|
Description of Endologix, Inc. Capital Stock
|
|
|
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 Indenture in respect of 5.00% Mandatory Convertible Senior Notes due 2024 (Incorporated by reference to Exhibit 4.5 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 1, 2019).
|
|
|
Form of 5.00% Mandatory Convertible Senior Note due 2024 (Incorporated by reference to Exhibit 4.6 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 1, 2019).
|
|
|
Form of Indenture, dated April 3, 2019, in respect of 5.00% Voluntary Convertible Senior Notes due 2024 (Incorporated by reference to Exhibit 4.7 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 1, 2019).
|
|
|
Form of Indenture, dated February 24, 2020, in respect of 5.00% Voluntary Convertible Senior Notes due 2024 (Incorporated by reference to Exhibit 4.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on February 24, 2020).
|
|
|
Form of 5.00% Voluntary Convertible Senior Note due 2024, issued on April 3, 2019 (Incorporated by reference to Exhibit 4.8 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 1, 2019).
|
|
|
Form of 5.00% Voluntary Convertible Senior Note due 2024, issued on February 24, 2020 (Incorporated by reference to Exhibit 4.3 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on February 24, 2020).
|
|
|
Form of Pre-Paid Warrant to Purchase Common Stock (Incorporated by reference to Exhibit 4.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 1, 2019).
|
Exhibit Number
|
|
Exhibit Description
|
|
Form of Amended and Restated (2017) Warrant (Incorporated by reference to Exhibit 4.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 1, 2019).
|
|
|
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).
|
|
|
Form of Amended and Restated Additional (2018) Warrant (Incorporated by reference to Exhibit 4.3 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 1, 2019).
|
|
|
Form of First Out Waterfall Note (Incorporated by reference to Exhibit 4.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on February 24, 2020).
|
|
|
Note, issued August 9, 2018, issued by Endologix, Inc. and certain of its subsidiaries to Deerfield Private
Design Fund III, L.P. (Incorporated by reference to Exhibit 4.8 to Endologix, Inc. Current Report on Form
8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
Note, issued August 9, 2018, issued by Endologix, Inc. and certain of its subsidiaries to Deerfield Private
Design Fund IV, L.P. (Incorporated by reference to Exhibit 4.9 to Endologix, Inc. Current Report on Form
8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
Note, issued August 9, 2018, issued by Endologix, Inc. and certain of its subsidiaries to Deerfield
Partners, L.P. (Incorporated by reference to Exhibit 4.10 to Endologix, Inc. Current Report on Form 8-K,
File No. 000-28440, filed on August 10, 2018).
|
|
|
Last Out Waterfall Note ($40,500,000), issued August 9, 2018, issued by Endologix, Inc. to Deerfield
Partners, L.P. (Incorporated by reference to Exhibit 4.11 to Endologix, Inc. Current Report on Form 8-K,
File No. 000-28440, filed on August 10, 2018).
|
|
(1)
|
Amended and Restated 2006 Employee Stock Purchase Plan, as amended (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on November 7, 2019).
|
|
(1)
|
Amended and Restated 2015 Stock Incentive Plan, as amended (Incorporated by reference to Appendix A to Endologix, Inc. Definitive Proxy Statement on Schedule 14A, File No. 000-28440, filed on July 8, 2019).
|
|
(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)(2)
|
2017 Inducement Stock Incentive Plan, as amended.
|
|
(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)
|
Amended and Restated Employment Agreement, dated as of December 4, 2018, by and between Endologix, Inc. and Vaseem Mahboob (Incorporated by reference to Exhibit 10.5 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on April 1, 2019).
|
|
(1)
|
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. (Incorporated by reference to Exhibit 10.9.1 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 13, 2018).
|
|
(1)
|
Second Amendment to Restricted Stock Award Agreement, dated December 15, 2017, by and between Endologix, Inc. and Robert D. Mitchell. (Incorporated by reference to Exhibit 10.9.2 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 13, 2018).
|
|
(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).
|
Exhibit Number
|
|
Exhibit Description
|
(1)
|
Employment Agreement, dated as of May 2, 2018, by and between Endologix, Inc. and John Onopchenko (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on August 9, 2018).
|
|
(1)
|
Employment Agreement, dated as of June 25, 2018, by and between Endologix, Inc. and Jeffrey Fecho (Incorporated by reference to Exhibit 10.3 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on August 9, 2019).
|
|
(1)
|
Amended and Restated Employment Agreement, dated as of December 4, 2018, by and between Endologix, Inc. and Jeremy Hayden (Incorporated by reference to Exhibit 10.11 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on April 1, 2019).
|
|
(1)
|
Amended and Restated Employment Agreement, dated as of December 4, 2018, by and between Endologix, Inc. and Matthew Thompson (Incorporated by reference to Exhibit 10.12 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on April 1, 2019).
|
|
(1)
|
Employment Agreement, dated as of January 7, 2019, by and between Endologix, Inc. and John Zehren (Incorporated by reference to Exhibit 10.4 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on August 9, 2019).
|
|
|
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).
|
|
|
Credit Agreement, dated August 9, 2018, by and among Endologix, Inc. and Deerfield ELGX Revolver, LLC and certain of its affiliates (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
First Amendment to Credit Agreement, dated November 20, 2018, by and among Endologix, Inc. and ELGX Revolver, LLC and certain of its affiliates (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on November 26, 2018).
|
|
|
Second Amendment to Credit Agreement and First Amendment to Guaranty and Security Agreement, dated March 31, 2019, by and among Endologix, Inc. and Deerfield ELGX Revolver, LLC and certain of its affiliates (Incorporated by reference to Exhibit 10.3 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 1, 2019).
|
|
†
|
Third Amendment to Credit Agreement, dated May 31, 2019, by and between Endologix, Inc. and Deerfield Partners, L.P. and certain of this affiliates (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on August 9, 2019).
|
|
|
Fourth Amendment to Credit Agreement, dated February 24, 2020, by and among Endologix, Inc. and Deerfield ELGX Revolver, LLC and certain of its affiliates (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on February 24, 2020).
|
|
|
Amended and Restated Facility Agreement, dated August 9, 2018, by and among Endologix, Inc. and Deerfield Private Design Fund IV, L.P. and certain of its affiliates (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
First Amendment to Amended and Restated Facility Agreement, dated November 20, 2018, by and among Endologix, Inc. and Deerfield Private Design Fund IV, L.P. and certain of its affiliates (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on November 26, 2018).
|
|
|
Second Amendment to Amended and Restated Facility Agreement and First Amendment to Guaranty and Security Agreement, dated March 31, 2019, by and among Endologix, Inc. and Deerfield Private Design Fund IV, L.P. and certain of its affiliates (Incorporated by reference to Exhibit 10.4 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 1, 2019).
|
|
†
|
Third Amendment to Amended and Restated Facility Agreement, dated May 31, 2019, by and between Endologix, Inc. and Deerfield Private Design Fund IV, L.P. and certain of this affiliates (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Quarterly Report on Form 10-Q, File No. 000-28440, filed on August 9, 2019).
|
|
|
Amended and Restated Registration Rights Agreement, dated August 9, 2018, by and between Endologix, Inc. and Deerfield Private Design Fund IV, L.P. (Incorporated by reference to Exhibit 10.3 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
Exhibit Number
|
|
Exhibit Description
|
|
Amended and Restated Guaranty and Security Agreement, dated August 9, 2018, by and among Endologix, Inc., its subsidiaries and Deerfield Private Design Fund IV, L.P. (Incorporated by reference to Exhibit 10.4 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
Guaranty and Security Agreement, dated August 9, 2018, by and among Endologix, Inc., its subsidiaries and Deerfield ELGX Revolver, LLC. (Incorporated by reference to Exhibit 10.5 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
Intercompany Subordination Agreement, dated August 9, 2018, by and among Endologix, Inc., its subsidiaries and Deerfield Private Design Fund IV, L.P. (Incorporated by reference to Exhibit 10.6 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
Intercompany Subordination Agreement, dated August 9, 2018, by and among Endologix, Inc., its subsidiaries and Deerfield ELGX Revolver, LLC. (Incorporated by reference to Exhibit 10.7 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
Junior Lien Security Agreement, dated February 24, 2020, by and between Endologix, Inc. and Wilmington Trust, National Association (Incorporated by reference to Exhibit 10.5 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on February 24, 2020).
|
|
|
Intercreditor Agreement, dated August 9, 2018, by and among Endologix, Inc., its subsidiaries, Deerfield ELGX Revolver, LLC and Deerfield Private Design Fund IV, L.P. (Incorporated by reference to Exhibit 10.8 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
Subordination and Intercreditor Agreement, dated February 24, 2020, by and among Endologix, Inc., Deerfield Private Design Fund IV, L.P., Deerfield ELGX Revolver, LLC and Wilmington Trust, National Association (Incorporated by reference to Exhibit 10.4 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on February 24, 2020).
|
|
|
Reaffirmation Agreement, dated August 9, 2018, by and among Endologix, Inc., its subsidiaries and Deerfield Private Design Fund IV, L.P. (Incorporated by reference to Exhibit 10.9 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
Patent Security Agreement, dated August 9, 2018, by and among Endologix, Inc., certain of its subsidiaries and Deerfield ELGX Revolver, LLC. (Incorporated by reference to Exhibit 10.10 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
Trademark Security Agreement, dated August 9, 2018, by and among Endologix, Inc., certain of its subsidiaries and Deerfield ELGX Revolver, LLC. (Incorporated by reference to Exhibit 10.11 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
First Supplement to Patent Security Agreement, dated August 9, 2018, by and among Endologix, Inc., certain of its subsidiaries and Deerfield Private Design Fund IV, L.P. (Incorporated by reference to Exhibit 10.12 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
First Supplement to Trademark Security Agreement, dated August 9, 2018, by and among Endologix, Inc., certain of its subsidiaries and Deerfield Private Design Fund IV, L.P. (Incorporated by reference to Exhibit 10.13 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on August 10, 2018).
|
|
|
Purchase Agreement, dated March 31, 2019, by and among Endologix, Inc. and the investors named on Schedule I thereto (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 1, 2019).
|
|
|
Exchange Agreement, dated March 31, 2019, by and among Endologix, Inc. and the noteholders named on Schedule A thereto (Incorporated by reference to Exhibit 10.2 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on April 1, 2019).
|
|
|
Exchange Agreement, dated February 24, 2020, by and among Endologix, Inc. and the noteholders named on Schedule A thereto (Incorporated by reference to Exhibit 10.1 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on February 24, 2020).
|
|
|
February 2020 Exchange Agreement and Fourth Amendment to Amended and Restated Facility Agreement and Amendment First Out Waterfall Notes, dated February 24, 2020, by and among Endologix, Inc. and Deerfield Private Design Fund IV, L.P. and certain of its affiliates (Incorporated by reference to Exhibit 10.3 to Endologix, Inc. Current Report on Form 8-K, File No. 000-28440, filed on February 24, 2020).
|
|
|
Lease Agreement, dated June 16, 2005, by and among TriVascular, Inc., Carmel River, LLC, Carlsen Investments, LLC, and Rieger Investments, LLC. (Incorporated by reference to Exhibit 10.23 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 13, 2018).
|
Exhibit Number
|
|
Exhibit Description
|
|
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. (Incorporated by reference to Exhibit 10.23.1 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 13, 2018).
|
|
|
Second Amendment to Lease, dated December 6, 2011, by and among TriVascular, Inc., Sonoma Airport Properties LLC and Boston Scientific Corporation. (Incorporated by reference to Exhibit 10.23.2 to Endologix, Inc. Annual Report on Form 10-K, File No. 000-28440, filed on March 13, 2018).
|
|
|
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).
|
|
|
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/ JOHN ONOPCHENKO
|
|
|
John Onopchenko
Chief Executive Officer
(Principal Executive Officer)
|
Signature
|
|
Title
|
|
Date
|
|
|
|
||
/s/ JOHN ONOPCHENKO
|
|
Chief Executive Officer and Director
|
|
March 11, 2020
|
(John Onopchenko)
|
|
(Principal Executive Officer)
|
|
|
|
|
|
||
/s/ VASEEM MAHBOOB
|
|
Chief Financial Officer
|
|
March 11, 2020
|
(Vaseem Mahboob)
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
||
|
|
|
||
/s/ DAN LEMAITRE
|
|
Chairman of the Board
|
|
March 11, 2020
|
(Dan Lemaitre)
|
|
|
|
|
|
|
|
||
/s/ THOMAS F. ZENTY III
|
|
Director
|
|
March 11, 2020
|
(Thomas F. Zenty III)
|
|
|
|
|
|
|
|
||
/s/ THOMAS C. WILDER
|
|
Director
|
|
March 11, 2020
|
(Thomas C. Wilder)
|
|
|
|
|
|
|
|
||
/s/ GREGORY D. WALLER
|
|
Director
|
|
March 11, 2020
|
(Gregory D. Waller)
|
|
|
|
|
|
|
|
||
/s/ LESLIE V. NORWALK
|
|
Director
|
|
March 11, 2020
|
(Leslie V. Norwalk)
|
|
|
|
|
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