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☒
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐
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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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41-1698056
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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1225 Old Highway 8 Northwest
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St. Paul,
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Minnesota
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55112-6416
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Trading Symbol
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Name of each exchange on which registered
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Common Stock, One-tenth of One Cent ($0.001)
Par Value Per Share |
CSII
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The Nasdaq Stock Market LLC
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Large accelerated filer
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☑
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Accelerated filer
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☐
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Non-accelerated filer
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☐
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Smaller reporting company
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☐
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Emerging growth company
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☐
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Page No.
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Item 1.
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Item 1A.
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Item 1B.
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Item 2.
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Item 3.
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Item 4.
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Item 5.
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Item 6.
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Item 7.
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Item 7A.
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Item 8.
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Item 9.
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Item 9A.
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Item 9B.
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Item 10.
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Item 11.
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Item 12.
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Item 13.
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Item 14.
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Item 15.
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•
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Below-the-Knee and Behind-the-Knee Peripheral Artery Disease. Arteries below and behind the knee are smaller in diameter and may be diffusely stenosed, calcified or both. Reaching and treating these small vessels requires a low profile, which most competitive devices do not offer. Behind-the-knee, or popliteal, lesions also present challenges if a stent is used because stents frequently fracture in this area due to the forces exerted on the vessels when the knee bends or flexes. The Peripheral OAS is effective in treating those vessels. The Peripheral OAS offers a shorter shaft length (60cm), a smaller profile and a more flexible shaft than the predecessors for improved ease of use, and includes a 4-Fr catheter that enables physicians to access lesions below-the-knee using retrograde access through arteries in the ankle or foot.
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•
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Above-the-Knee Peripheral Artery Disease. Arteries above the knee are typically longer, straighter and wider than below-the-knee vessels. Plaque in these arteries may also be diffuse, fibrotic and calcific. Physicians often use higher speeds or larger crown sizes of our products to treat lesions above the knee. Our newest Peripheral OAS innovation includes the addition of extended length OAS that can treat above-the-knee disease through trans-radial access (access through the radial artery in the wrist). The ability to treat the larger above-the-knee arteries with OAS via the small trans-radial access sites is made possible by the unique features of the OAS including its small crossing profile and ability to orbit at higher speeds for treatment of larger vessels.
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•
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Coronary Artery Disease. The individuals more at risk for being diagnosed with CAD are those that are suffering from high blood pressure, abnormal cholesterol levels, diabetes, renal insufficiency, or have a family history of heart disease. The pathogenesis of CAD is marked by the accumulation of a fatty material called plaque on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The Coronary OAS is the only atherectomy device specifically indicated for severe coronary calcium.
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•
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Guidewires. The ViperWire guide wires are required for using the OAS and were designed to offer the ability to maneuver through tortuous, twisting blood vessels and cross challenging lesions. The OAS travels over this wire to the lesion and operates on this wire. Our ZILIENT Peripheral guidewires further expand our low-profile endovascular portfolio and feature TWISTER® Core Wire Technology, a proprietary stainless steel core design that offers strong support with navigation and torque response. The ZILIENT guidewires are designed to get to and across lesions and includes four tip load choices across two diameters.
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•
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Catheters. We sell OrbusNeich Teleport Microcatheters in the United States through an exclusive distribution agreement with OrbusNeich. We also sell our ViperCath XC Peripheral Exchange Catheter, which is the only 200 cm exchange catheter available to address the need for an extended length catheter when performing procedures with a radial access point.
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•
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Balloons. We sell the OrbusNeich Sapphire semi compliant (“SC”) and Sapphire non-compliant (“NC”) balloon portfolio in the United States, which includes the only 1.0mm SC balloon on the United States market. Sapphire SC balloons are optimized for lesion entry and crossing with stainless steel hypo-tube for increased pushability and kink resistance. Sapphire NC balloons are optimized for robustness under high pressure and reliable sizing.
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•
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Other OAS Support Products. Our OAS uses a small, portable saline infusion pump that bathes the OAS shaft and crown and provides an electric power supply for the operation of the catheter. We also sell ViperSlide Lubricant designed to optimize the smooth operation of the OAS.
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•
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Drive Adoption through Our Direct U.S. Sales Organization, Medical Education and Key Opinion Leaders. We expect to continue to drive adoption of the OAS in both hospital and office-based lab settings through the strong support of a clinically knowledgeable direct U.S. sales force focused on the needs of interventional cardiologists, vascular surgeons, interventional radiologists and their cath lab teams. A key element of our strategy is a focus on educating and training physicians about disease states, our clinical data, and proper use and application of OAS technology through programs delivered via physician faculty, our direct sales force and seminars where physician industry leaders discuss case studies and treatment techniques using the devices.
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•
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Build a Strong Portfolio of Clinical Evidence on Safety, Effectiveness and Economic Benefits of the OAS. Physicians and payors are increasingly interested in clinical and economic evidence to support decisions regarding optimal treatment of patients. We are focused on conducting robust clinical studies that provide insight into and demonstrate the effectiveness of the OAS in treating complex peripheral and coronary artery disease. We believe that demonstrating the clinical advantages and cost-effectiveness of our OAS technology is critical to support physician adoption of the OAS, drive best clinical practice, and sustain ongoing reimbursement coverage for our devices.
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•
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Enhance OAS and Expand Product Portfolio within the Market for Treatment of Peripheral and Coronary Arteries. In addition to continued innovation and product development on our peripheral and coronary OAS platforms, we are growing our product portfolio to offer new accessories and devices that improve outcomes and expand the patient population we can treat. See “Pursue Strategic Acquisitions and Partnerships” and “Research and Development Activities - Development Activities” for descriptions of new products in development.
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•
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Expand Internationally. In February 2018, we announced reimbursement approval and our first commercially treated patient in Japan. This represented our first entry into the international market, and most importantly, an opportunity to provide physicians in Japan with a cost-effective treatment option for the difficult-to-treat patient population with severely calcified coronary lesions. In January 2019, Japan’s MHLW approved our Coronary OAS Classic Crown, and in the third quarter of fiscal 2019, sales of this product commenced in Japan.
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•
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Pursue Strategic Acquisitions and Partnerships. In addition to adding to our product portfolio through internal development efforts, we are opportunistically seeking ways to expand our portfolio through acquisitions, distribution agreements, licensing transactions, manufacturing agreements and other strategic partnerships to add new product lines and technologies that leverage our sales expertise and footprint or complement our strategic objectives. We have an exclusive U.S. distribution agreement with OrbusNeich to offer their full line of semi-compliant, non-compliant and specialty balloons and the Teleport Microcatheter. In addition, we have entered into an agreement with Integer Holdings Corporation to manufacture our ZILIENT™ peripheral guidewires, and we are co-developing a new laser atherectomy device in collaboration with Aerolase Corporation. Finally, in August 2019, we acquired the WIRION Embolic Protection System and related assets from Gardia Medical Ltd., a wholly owned Israeli subsidiary of Allium Medical Solutions Ltd. This device is a distal embolic protection filter used to capture debris that can be associated with all types of peripheral vascular intervention procedures. We plan to commercialize the WIRION System in the United States following the transfer of manufacturing from Gardia Medical, which we expect to be completed after a 12 to 15 month transition period. Gardia Medical has retained the rights to the WIRION System for angioplasty and stenting procedures in the carotid arteries.
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•
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REACH-PVI. This prospective, observational, single-arm, multi-center post-market study conducted in the United States is designed to evaluate acute clinical outcomes of orbital atherectomy via transradial access for treatment of PAD in lower extremity lesions. Approximately 50 subjects will be enrolled in REACH-PVI and will be followed post-procedure through the first standard of care follow-up visit (7 to 45 days post-procedure).
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•
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LIBERTY 360°. This prospective, observational, multi-center clinical study is evaluating the procedural and long-term clinical, quality of life and economic outcomes of endovascular device interventions, including orbital atherectomy, for the treatment of PAD. We expect the results from this study to increase our understanding of the clinical and economic outcomes of endovascular treatment for PAD patients, including those with the most advanced form of the disease, Rutherford Class 6. Enrollment of 1,204 subjects at 51 sites in the United States was completed in February 2016.
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•
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ECLIPSE. This post-market, randomized one-to-one, multi-center trial is designed to evaluate vessel preparation with Coronary OAS Classic Crown compared to conventional angioplasty technique prior to drug-eluting stent implantation for the treatment of severely calcified lesions. Approximately 2,000 subjects will be enrolled at approximately 150 sites in the United States and subjects will be followed for up to two years. The co-primary endpoints of acute minimum stent area (assessed by optical coherence tomography in a subset of equally randomized 500 subjects) and one-year target vessel failure are powered to demonstrate superiority of OAS vessel preparation vs. conventional angioplasty.
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•
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clinical results showing safety and efficacy of our products;
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•
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educating physicians on the prevalence and complications of calcium in PAD and CAD; and
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•
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developing relationships with key opinion leaders.
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•
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safety and efficacy, even in calcified plaque (or severely calcified plaque in the coronaries);
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•
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low profile and alternative access site capabilities;
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•
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predictable clinical performance;
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•
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availability of clinical data;
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•
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ease of use;
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•
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economic benefit;
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•
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key opinion leader support and customer base; and
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•
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customer service and support.
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•
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the systems may not be safe or effective to the FDA’s satisfaction;
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•
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the data from preclinical studies and clinical trials may be insufficient to support approval;
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•
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the manufacturing process or facilities used may not meet applicable requirements; and
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•
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changes in FDA approval policies or adoption of new regulations may require additional data.
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•
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establishment registration and device listing upon the commencement of manufacturing;
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•
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the QSR, which requires manufacturers, including third-party manufacturers, to follow design, testing, control, documentation and other quality assurance procedures during medical device design and manufacturing processes;
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•
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labeling regulations, which prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling and promotional activities;
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•
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medical device reporting regulations, which require that manufacturers report to the FDA if a device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if malfunctions were to recur;
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•
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corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections; and
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•
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product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA caused by the device that may present a risk to health.
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•
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warning letters or untitled letters;
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•
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fines, injunctions and civil penalties;
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•
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product recall or seizure;
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•
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unanticipated expenditures;
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•
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delays in clearing or approving or refusal to clear or approve products;
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•
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withdrawal or suspension of FDA approval;
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•
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orders for physician notification or device repair, replacement or refund;
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•
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operating restrictions, partial suspension or total shutdown of production or clinical trials; or
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•
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criminal prosecution.
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Name
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Age
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Position
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Scott R. Ward
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59
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Chairman, President and Chief Executive Officer
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Ryan D. Egeland
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44
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Chief Medical Officer
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John M. Hastings
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39
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Vice President of Manufacturing and Operations
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Jeffrey S. Points
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42
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Chief Financial Officer
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Rhonda J. Robb
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51
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Chief Operating Officer
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Alexander Rosenstein
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47
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General Counsel and Corporate Secretary
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Sandra M. Sedo
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55
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Chief Compliance Officer
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David S. Whitescarver
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61
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Vice President of Corporate Development and Intellectual Property
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•
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the actual and perceived effectiveness and reliability of our products;
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•
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the prevalence and severity of any adverse patient events involving our products;
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•
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the results of any clinical trials relating to use of our products;
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•
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the availability, relative cost and perceived advantages and disadvantages of alternative technologies or treatment methods for conditions treated by our products;
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•
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the degree to which treatments using our products are approved for reimbursement by public and private insurers;
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•
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the degree to which physicians adopt our products;
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•
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the extent to which we are successful in educating physicians about PAD and CAD in general and the existence and benefits of our products in particular;
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•
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the strength of our marketing and distribution infrastructure;
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•
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the level of education and awareness among physicians and hospitals concerning our products; and
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•
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our reputation among physicians and hospitals.
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•
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develop and patent processes or products earlier than we will;
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•
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obtain regulatory clearances or approvals for competing medical device products more rapidly than we will;
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•
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market their products more effectively than we will;
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•
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sell their products at lower prices than we do; or
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•
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develop more effective or less expensive products or technologies that render our technology or products obsolete or non-competitive.
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•
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announcements of technological or medical innovations for the treatment of vascular disease;
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•
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quarterly variations in our or our competitors’ results of operations;
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•
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failure to meet estimates or recommendations by securities analysts who cover our stock;
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•
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failure to meet our own financial estimates;
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•
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accusations that we have violated a law or regulation;
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•
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recalls of our products;
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•
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significant litigation;
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•
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sales of large blocks of our common stock, including sales by our executive officers, directors and significant stockholders;
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•
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changes in accounting principles;
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•
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actual or anticipated changes in healthcare policy and reimbursement levels;
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•
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developments relating to our competitors and markets; and
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•
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general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
|
•
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the business culture of the acquired business may not match well with our culture;
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•
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technological and product synergies, economies of scale and cost reductions may not occur as expected;
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•
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we may acquire or assume unexpected liabilities;
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•
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we may fail to retain, motivate and integrate key management and other employees of the acquired business;
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•
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higher than expected finance costs may arise due to unforeseen changes in tax, trade, environmental, labor, safety, payroll or pension policies in any jurisdiction in which the acquired business conducts its operations;
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•
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we may experience problems in retaining suppliers or customers of the acquired business;
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•
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we may not be able to effectively integrate internal control processes of the acquired business into our business; and
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•
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we may not be able to operate acquired businesses profitably.
|
•
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warning or other letters from the FDA;
|
•
|
fines, injunctions and civil penalties;
|
•
|
product recall or seizure;
|
•
|
unanticipated expenditures;
|
•
|
delays in clearing or approving or refusal to clear or approve products;
|
•
|
withdrawal or suspension of approval or clearance by the FDA or other regulatory bodies;
|
•
|
orders for physician notification or device repair, replacement or refund;
|
•
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operating restrictions, partial suspension or total shutdown of production or clinical trials; and
|
•
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criminal prosecution.
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Item 5.
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Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
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Total Number of Shares Purchased
|
|
Average Price Paid per Share
|
|
Total Number of Shares Purchased as part of Publicly Announced Plans or Programs
|
|
Approximate Dollar Value of Shares that May Yet Be Purchased under the Plans or Programs
|
|||
April 1 to April 30, 2019
|
—
|
|
|
—
|
|
|
N/A
|
|
N/A
|
|
May 1 to May 31, 2019(1)
|
2,076
|
|
|
$
|
39.79
|
|
|
N/A
|
|
N/A
|
June 1 to June 30, 2019
|
—
|
|
|
—
|
|
|
N/A
|
|
N/A
|
|
|
2,076
|
|
|
$
|
39.79
|
|
|
|
|
|
|
Year Ended June 30,
|
||||||||||||
|
2019
|
|
2018
|
|
Change
|
Percent
Change
|
|||||||
Net revenues
|
$
|
248,017
|
|
|
$
|
217,043
|
|
|
$
|
30,974
|
|
14.3
|
%
|
Cost of goods sold
|
47,680
|
|
|
39,484
|
|
|
8,196
|
|
20.8
|
|
|||
Gross profit
|
200,337
|
|
|
177,559
|
|
|
22,778
|
|
12.8
|
|
|||
Gross margin
|
80.8
|
%
|
|
81.8
|
%
|
|
(1.0
|
)%
|
(1.2
|
)
|
|||
Expenses:
|
|
|
|
|
|
|
|||||||
Selling, general and administrative
|
167,700
|
|
|
148,569
|
|
|
19,131
|
|
12.9
|
|
|||
Research and development
|
33,462
|
|
|
26,756
|
|
|
6,706
|
|
25.1
|
|
|||
Total expenses
|
201,162
|
|
|
175,325
|
|
|
25,837
|
|
14.7
|
|
|||
Income (loss) from operations
|
(825
|
)
|
|
2,234
|
|
|
(3,059
|
)
|
(136.9
|
)
|
|||
Other (income) and expense, net
|
(760
|
)
|
|
390
|
|
|
(1,150
|
)
|
(294.9
|
)
|
|||
(Loss) income before income taxes
|
(65
|
)
|
|
1,844
|
|
|
(1,909
|
)
|
(103.5
|
)
|
|||
Provision for income taxes
|
190
|
|
|
132
|
|
|
58
|
|
43.9
|
|
|||
Net (loss) income
|
$
|
(255
|
)
|
|
$
|
1,712
|
|
|
$
|
(1,967
|
)
|
(114.9
|
)
|
|
Year Ended June 30,
|
||||||
|
2019
|
|
2018
|
||||
Net (loss) income
|
$
|
(255
|
)
|
|
$
|
1,712
|
|
Less: Other (income) and expense, net
|
(760
|
)
|
|
390
|
|
||
Less: Provision for income taxes
|
190
|
|
|
132
|
|
||
(Loss) income from operations
|
(825
|
)
|
|
2,234
|
|
||
Add: Stock-based compensation
|
11,266
|
|
|
10,302
|
|
||
Add: Depreciation and amortization
|
3,446
|
|
|
3,934
|
|
||
Adjusted EBITDA
|
$
|
13,887
|
|
|
$
|
16,470
|
|
•
|
Stock-based compensation. Our management believes that excluding this item from our non-GAAP results is useful to investors to understand the application of stock-based compensation guidance and its impact on our operational performance and ability to make additional investments in our company, and it allows for greater transparency to certain line items in our financial statements.
|
•
|
Depreciation and amortization expense. Our management believes that excluding these items from our non-GAAP results is useful to investors to understand our operational performance and ability to make additional investments in our company.
|
•
|
Items such as stock-based compensation do not directly affect our cash flow position; however, such items reflect economic costs to us and are not reflected in our Adjusted EBITDA, and therefore these non-GAAP measures do not reflect the full economic effect of these items.
|
•
|
Non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles and therefore other companies may calculate similarly titled non-GAAP financial measures differently than we do, limiting the usefulness of those measures for comparative purposes.
|
•
|
Our management exercises judgment in determining which types of charges or other items should be excluded from the non-GAAP financial measures we use.
|
|
Year Ended June 30,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Net cash provided by operating activities
|
$
|
10,208
|
|
|
$
|
9,674
|
|
|
$
|
19,588
|
|
Net cash used in investing activities
|
(54,352
|
)
|
|
(5,095
|
)
|
|
(1,779
|
)
|
|||
Net cash provided by financing activities
|
2,121
|
|
|
3,769
|
|
|
29,465
|
|
|||
Net change in cash and cash equivalents
|
$
|
(42,023
|
)
|
|
$
|
8,348
|
|
|
$
|
47,274
|
|
|
Payments Due by Period (in thousands)
|
||||||||||||||||||
Contractual Obligations
|
Total
|
|
Less Than
1 Year
|
|
1-3
Years
|
|
3-5
Years
|
|
More Than
5 Years
|
||||||||||
Operating leases(1)
|
$
|
441
|
|
|
$
|
392
|
|
|
$
|
47
|
|
|
$
|
2
|
|
|
$
|
—
|
|
Financing obligation(2)
|
26,698
|
|
|
1,750
|
|
|
3,660
|
|
|
3,883
|
|
|
17,405
|
|
|||||
Purchase commitments(3)
|
24,136
|
|
|
24,136
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Legal settlement(4)
|
467
|
|
|
467
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Other(5)
|
144
|
|
|
107
|
|
|
37
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
$
|
51,886
|
|
|
$
|
26,852
|
|
|
$
|
3,744
|
|
|
$
|
3,885
|
|
|
$
|
17,405
|
|
(1)
|
The amounts represent future minimum payments under a non-cancellable operating lease for our Texas production facility along with equipment leases.
|
(2)
|
The amounts represent future minimum payments due under the capital lease related to the sale leaseback of our Facility.
|
(3)
|
The amount represents open purchase orders as of June 30, 2019.
|
(4)
|
Consists of payments and related interest associated with the previously disclosed Department of Justice settlement.
|
(5)
|
Other includes service agreements and severance arrangements.
|
|
Page
|
F-1
|
|
F-3
|
|
F-4
|
|
F-5
|
|
F-6
|
|
F-7
|
|
F-8
|
|
June 30,
2019 |
|
June 30,
2018 |
||||
ASSETS
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
74,237
|
|
|
$
|
116,260
|
|
Marketable securities
|
48,435
|
|
|
544
|
|
||
Accounts receivable, net
|
36,015
|
|
|
31,225
|
|
||
Inventories
|
18,058
|
|
|
16,605
|
|
||
Prepaid expenses and other current assets
|
3,330
|
|
|
2,977
|
|
||
Total current assets
|
180,075
|
|
|
167,611
|
|
||
Property and equipment, net
|
27,324
|
|
|
27,744
|
|
||
Patents, net
|
5,105
|
|
|
5,231
|
|
||
Other assets
|
6,073
|
|
|
2,766
|
|
||
Total assets
|
$
|
218,577
|
|
|
$
|
203,352
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable
|
11,194
|
|
|
10,441
|
|
||
Accrued expenses
|
29,387
|
|
|
25,776
|
|
||
Deferred revenue
|
1,764
|
|
|
1,243
|
|
||
Total current liabilities
|
42,345
|
|
|
37,460
|
|
||
Long-term liabilities
|
|
|
|
||||
Financing obligation
|
20,972
|
|
|
21,064
|
|
||
Deferred revenue
|
6,541
|
|
|
8,946
|
|
||
Other liabilities
|
775
|
|
|
1,412
|
|
||
Total liabilities
|
70,633
|
|
|
68,882
|
|
||
Commitments and contingencies
|
|
|
|
||||
Common stock, $0.001 par value; authorized 100,000,000 common shares; issued and outstanding 34,934,569 at June 30, 2019 and 33,360,032 at June 30, 2018
|
34
|
|
|
33
|
|
||
Additional paid in capital
|
477,368
|
|
|
461,927
|
|
||
Accumulated other comprehensive income
|
78
|
|
|
101
|
|
||
Accumulated deficit
|
(329,536
|
)
|
|
(327,591
|
)
|
||
Total stockholders’ equity
|
147,944
|
|
|
134,470
|
|
||
Total liabilities and stockholders’ equity
|
$
|
218,577
|
|
|
$
|
203,352
|
|
|
Year Ended June 30,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Net revenues
|
$
|
248,017
|
|
|
$
|
217,043
|
|
|
$
|
204,906
|
|
Cost of goods sold
|
47,680
|
|
|
39,484
|
|
|
39,441
|
|
|||
Gross profit
|
200,337
|
|
|
177,559
|
|
|
165,465
|
|
|||
Expenses:
|
|
|
|
|
|
||||||
Selling, general and administrative
|
167,700
|
|
|
148,569
|
|
|
144,096
|
|
|||
Research and development
|
33,462
|
|
|
26,756
|
|
|
22,911
|
|
|||
Total expenses
|
201,162
|
|
|
175,325
|
|
|
167,007
|
|
|||
(Loss) income from operations
|
(825
|
)
|
|
2,234
|
|
|
(1,542
|
)
|
|||
Other (income) expense, net:
|
|
|
|
|
|
||||||
Interest expense
|
1,684
|
|
|
1,717
|
|
|
500
|
|
|||
Interest income and other, net
|
(2,444
|
)
|
|
(1,327
|
)
|
|
(336
|
)
|
|||
Total other (income) expense, net
|
(760
|
)
|
|
390
|
|
|
164
|
|
|||
(Loss) income before income taxes
|
(65
|
)
|
|
1,844
|
|
|
(1,706
|
)
|
|||
Provision for income taxes
|
190
|
|
|
132
|
|
|
86
|
|
|||
Net (loss) income
|
$
|
(255
|
)
|
|
$
|
1,712
|
|
|
$
|
(1,792
|
)
|
|
|
|
|
|
|
||||||
Basic earnings per share
|
$
|
(0.01
|
)
|
|
$
|
0.05
|
|
|
$
|
(0.06
|
)
|
Diluted earnings per share
|
$
|
(0.01
|
)
|
|
$
|
0.05
|
|
|
$
|
(0.06
|
)
|
|
|
|
|
|
|
||||||
Basic weighted average shares outstanding
|
33,535,759
|
|
|
33,145,140
|
|
|
32,373,709
|
|
|||
Diluted weighted average shares outstanding
|
33,535,759
|
|
|
33,614,260
|
|
|
32,373,709
|
|
|
Year Ended June 30,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Net (loss) income
|
$
|
(255
|
)
|
|
$
|
1,712
|
|
|
$
|
(1,792
|
)
|
Other comprehensive income:
|
|
|
|
|
|
||||||
Unrealized gain on available-for-sale securities
|
78
|
|
|
35
|
|
|
66
|
|
|||
Adjustment for net gain realized and included in interest income and other, net
|
—
|
|
|
(34
|
)
|
|
(6
|
)
|
|||
Total change in unrealized gain on available for sale securities
|
78
|
|
|
1
|
|
|
60
|
|
|||
Comprehensive (loss) income
|
$
|
(177
|
)
|
|
$
|
1,713
|
|
|
$
|
(1,732
|
)
|
|
Common Stock
|
|
Additional
Paid In
Capital
|
|
Accumulated Other Comprehensive Income
|
|
Accumulated
Deficit
|
|
Total
|
||||||||||
|
|
|
|
||||||||||||||||
Balances at June 30, 2016
|
$
|
33
|
|
|
$
|
428,235
|
|
|
$
|
40
|
|
|
$
|
(327,411
|
)
|
|
$
|
100,897
|
|
Stock-based compensation related to restricted stock awards, net
|
—
|
|
|
9,412
|
|
|
—
|
|
|
—
|
|
|
9,412
|
|
|||||
Exercise of stock options at $7.90-$12.15 per share
|
—
|
|
|
5,362
|
|
|
—
|
|
|
(100
|
)
|
|
5,262
|
|
|||||
Employee stock purchase plan activity
|
—
|
|
|
4,550
|
|
|
—
|
|
|
—
|
|
|
4,550
|
|
|||||
Unrealized gain on marketable securities
|
—
|
|
|
—
|
|
|
66
|
|
|
—
|
|
|
66
|
|
|||||
Net gain reclassified from accumulated other comprehensive income
|
—
|
|
|
—
|
|
|
(6
|
)
|
|
—
|
|
|
(6
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,792
|
)
|
|
(1,792
|
)
|
|||||
Balances at June 30, 2017
|
$
|
33
|
|
|
$
|
447,559
|
|
|
$
|
100
|
|
|
$
|
(329,303
|
)
|
|
$
|
118,389
|
|
Stock-based compensation related to restricted stock awards, net
|
—
|
|
|
9,546
|
|
|
—
|
|
|
—
|
|
|
9,546
|
|
|||||
Exercise of stock options at $7.90-$12.15 per share
|
—
|
|
|
514
|
|
|
—
|
|
|
—
|
|
|
514
|
|
|||||
Employee stock purchase plan activity
|
—
|
|
|
4,308
|
|
|
—
|
|
|
—
|
|
|
4,308
|
|
|||||
Unrealized gain on marketable securities
|
—
|
|
|
—
|
|
|
35
|
|
|
—
|
|
|
35
|
|
|||||
Net gain reclassified from accumulated other comprehensive income
|
—
|
|
|
—
|
|
|
(34
|
)
|
|
—
|
|
|
(34
|
)
|
|||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
1,712
|
|
|
1,712
|
|
|||||
Balances at June 30, 2018
|
$
|
33
|
|
|
$
|
461,927
|
|
|
$
|
101
|
|
|
$
|
(327,591
|
)
|
|
$
|
134,470
|
|
Impact from adoption of ASU 2016-01 (See Note 5)
|
—
|
|
|
—
|
|
|
(101
|
)
|
|
101
|
|
|
—
|
|
|||||
Stock-based compensation related to restricted stock awards, net
|
1
|
|
|
10,355
|
|
|
—
|
|
|
—
|
|
|
10,356
|
|
|||||
Shares withheld for payroll taxes
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,791
|
)
|
|
(1,791
|
)
|
|||||
Exercise of stock options at $8.75 per share
|
—
|
|
|
196
|
|
|
—
|
|
|
—
|
|
|
196
|
|
|||||
Employee stock purchase plan activity
|
—
|
|
|
4,890
|
|
|
—
|
|
|
—
|
|
|
4,890
|
|
|||||
Unrealized gain on available-for-sale debt securities
|
—
|
|
|
—
|
|
|
78
|
|
|
—
|
|
|
78
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(255
|
)
|
|
(255
|
)
|
|||||
Balances at June 30, 2019
|
$
|
34
|
|
|
$
|
477,368
|
|
|
$
|
78
|
|
|
$
|
(329,536
|
)
|
|
$
|
147,944
|
|
|
Year Ended June 30,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Cash flows from operating activities
|
|
||||||||||
Net (loss) income
|
$
|
(255
|
)
|
|
$
|
1,712
|
|
|
$
|
(1,792
|
)
|
Adjustments to reconcile net (loss) income to net cash provided by operating activities
|
|
|
|
|
|
||||||
Depreciation of property and equipment
|
3,150
|
|
|
3,730
|
|
|
3,917
|
|
|||
Provision for (recovery of) doubtful accounts (including note receivable)
|
125
|
|
|
(225
|
)
|
|
465
|
|
|||
Amortization of patents
|
296
|
|
|
204
|
|
|
218
|
|
|||
Write-off of patent costs
|
800
|
|
|
497
|
|
|
733
|
|
|||
Stock-based compensation
|
11,266
|
|
|
10,302
|
|
|
10,354
|
|
|||
Accretion of discount on marketable securities
|
(55
|
)
|
|
—
|
|
|
—
|
|
|||
Loss on disposal of property and equipment and other
|
42
|
|
|
16
|
|
|
296
|
|
|||
Changes in assets and liabilities
|
|
|
|
|
|
||||||
Accounts receivable
|
(4,915
|
)
|
|
(2,878
|
)
|
|
(5,809
|
)
|
|||
Inventories
|
(1,453
|
)
|
|
292
|
|
|
543
|
|
|||
Prepaid expenses and other assets
|
(393
|
)
|
|
2,308
|
|
|
(1,823
|
)
|
|||
Accounts payable
|
566
|
|
|
104
|
|
|
1,761
|
|
|||
Accrued expenses and other liabilities
|
2,918
|
|
|
(6,577
|
)
|
|
725
|
|
|||
Deferred revenue
|
(1,884
|
)
|
|
189
|
|
|
10,000
|
|
|||
Net cash provided by operating activities
|
10,208
|
|
|
9,674
|
|
|
19,588
|
|
|||
Cash flows from investing activities
|
|
||||||||||
Expenditures for property and equipment
|
(2,665
|
)
|
|
(1,956
|
)
|
|
(981
|
)
|
|||
Purchases of long-term investments
|
(3,055
|
)
|
|
(2,538
|
)
|
|
—
|
|
|||
Purchases of marketable securities
|
(47,892
|
)
|
|
—
|
|
|
—
|
|
|||
Sales of marketable securities
|
150
|
|
|
194
|
|
|
46
|
|
|||
Costs incurred in connection with patents
|
(890
|
)
|
|
(1,113
|
)
|
|
(844
|
)
|
|||
Proceeds from convertible note receivable
|
—
|
|
|
318
|
|
|
—
|
|
|||
Net cash used in investing activities
|
(54,352
|
)
|
|
(5,095
|
)
|
|
(1,779
|
)
|
|||
Cash flows from financing activities
|
|
||||||||||
Proceeds from the employee stock purchase plan
|
3,752
|
|
|
3,242
|
|
|
3,254
|
|
|||
Payment of employee taxes related to vested restricted stock
|
(1,791
|
)
|
|
—
|
|
|
—
|
|
|||
Exercise of stock options
|
196
|
|
|
513
|
|
|
5,263
|
|
|||
Proceeds from financing
|
—
|
|
|
—
|
|
|
20,944
|
|
|||
Other
|
(36
|
)
|
|
14
|
|
|
4
|
|
|||
Net cash provided by financing activities
|
2,121
|
|
|
3,769
|
|
|
29,465
|
|
|||
Net change in cash and cash equivalents
|
(42,023
|
)
|
|
8,348
|
|
|
47,274
|
|
|||
Cash and cash equivalents
|
|
||||||||||
Beginning of period
|
116,260
|
|
|
107,912
|
|
|
60,638
|
|
|||
End of period
|
$
|
74,237
|
|
|
$
|
116,260
|
|
|
$
|
107,912
|
|
Supplemental cash flow information
|
|
||||||||||
Interest paid
|
$
|
1,684
|
|
|
$
|
1,717
|
|
|
$
|
500
|
|
|
Amount
|
||
Balance at June 30, 2016
|
$
|
712
|
|
Provision for doubtful accounts
|
465
|
|
|
Write-offs
|
(313
|
)
|
|
Balance at June 30, 2017
|
864
|
|
|
Provision for doubtful accounts
|
125
|
|
|
Write-offs
|
(189
|
)
|
|
Balance at June 30, 2018
|
800
|
|
|
Provision for doubtful accounts
|
125
|
|
|
Write-offs
|
(312
|
)
|
|
Balance at June 30, 2019
|
$
|
613
|
|
|
Amount
|
||
Balance at June 30, 2016
|
$
|
145
|
|
Provision
|
1,733
|
|
|
Claims
|
(1,361
|
)
|
|
Balance at June 30, 2017
|
517
|
|
|
Provision
|
328
|
|
|
Claims
|
(713
|
)
|
|
Balance at June 30, 2018
|
132
|
|
|
Provision
|
502
|
|
|
Claims
|
(501
|
)
|
|
Balance at June 30, 2019
|
$
|
133
|
|
|
June 30,
|
||||||
|
2019
|
|
2018
|
||||
Accounts receivable
|
$
|
36,628
|
|
|
$
|
32,025
|
|
Less: Allowance for doubtful accounts
|
(613
|
)
|
|
(800
|
)
|
||
Accounts receivable, net
|
$
|
36,015
|
|
|
$
|
31,225
|
|
|
June 30,
|
||||||
|
2019
|
|
2018
|
||||
Raw materials
|
$
|
5,547
|
|
|
$
|
6,820
|
|
Work in process
|
1,415
|
|
|
1,315
|
|
||
Finished goods
|
11,096
|
|
|
8,470
|
|
||
Inventories
|
$
|
18,058
|
|
|
$
|
16,605
|
|
|
June 30,
|
||||||
|
2019
|
|
2018
|
||||
Land
|
$
|
572
|
|
|
$
|
500
|
|
Building
|
22,420
|
|
|
22,420
|
|
||
Equipment
|
17,517
|
|
|
16,510
|
|
||
Furniture
|
2,975
|
|
|
2,709
|
|
||
Leasehold improvements
|
540
|
|
|
438
|
|
||
Construction in progress
|
1,328
|
|
|
1,110
|
|
||
|
45,352
|
|
|
43,687
|
|
||
Less: Accumulated depreciation
|
(18,028
|
)
|
|
(15,943
|
)
|
||
Total Property and equipment, net
|
$
|
27,324
|
|
|
$
|
27,744
|
|
|
June 30,
|
||||||
|
2019
|
|
2018
|
||||
Patents
|
$
|
6,093
|
|
|
$
|
6,435
|
|
Less: Accumulated amortization
|
(988
|
)
|
|
(1,204
|
)
|
||
Total Patents, net
|
$
|
5,105
|
|
|
$
|
5,231
|
|
2020
|
$
|
209
|
|
2021
|
209
|
|
|
2022
|
207
|
|
|
2023
|
201
|
|
|
2024
|
197
|
|
|
Thereafter
|
4,082
|
|
|
|
$
|
5,105
|
|
|
June 30,
|
||||||
|
2019
|
|
2018
|
||||
Salaries and bonus
|
$
|
11,105
|
|
|
$
|
6,624
|
|
Commissions
|
6,829
|
|
|
7,234
|
|
||
Accrued vacation
|
4,230
|
|
|
3,557
|
|
||
Accrued excise, sales and other taxes
|
3,349
|
|
|
3,522
|
|
||
Clinical studies
|
2,092
|
|
|
1,422
|
|
||
Legal settlement
|
467
|
|
|
1,847
|
|
||
Other accrued expenses
|
1,315
|
|
|
1,570
|
|
||
Total Accrued expenses
|
$
|
29,387
|
|
|
$
|
25,776
|
|
|
Year Ended June 30,
|
||||||||||
Product Category
|
2019
|
|
2018
|
|
2017
|
||||||
Peripheral
|
$
|
178,896
|
|
|
$
|
161,405
|
|
|
$
|
153,716
|
|
Coronary
|
69,121
|
|
|
55,638
|
|
|
51,190
|
|
|||
Total net revenues
|
$
|
248,017
|
|
|
$
|
217,043
|
|
|
$
|
204,906
|
|
|
|
|
|
|
|
||||||
Geography
|
|
|
|
|
|
||||||
United States
|
$
|
240,114
|
|
|
$
|
215,233
|
|
|
$
|
204,906
|
|
International
|
7,903
|
|
|
1,810
|
|
|
—
|
|
|||
Total net revenues
|
$
|
248,017
|
|
|
$
|
217,043
|
|
|
$
|
204,906
|
|
2020
|
$
|
1,750
|
|
2021
|
1,803
|
|
|
2022
|
1,857
|
|
|
2023
|
1,913
|
|
|
2024
|
1,970
|
|
|
Thereafter
|
17,405
|
|
|
|
$
|
26,698
|
|
|
June 30,
|
||||||
|
2019
|
|
2018
|
||||
Short-term available-for-sale debt securities
|
$
|
38,193
|
|
|
$
|
—
|
|
Long-term available-for-sale debt securities
|
9,832
|
|
|
—
|
|
||
Available-for-sale debt securities
|
48,025
|
|
|
—
|
|
||
Mutual funds
|
410
|
|
|
544
|
|
||
Total marketable securities
|
$
|
48,435
|
|
|
$
|
544
|
|
|
As of June 30, 2019
|
||||||||||||||
|
Amortized Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
||||||||
Commercial paper
|
$
|
14,277
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
14,277
|
|
Corporate debt
|
26,466
|
|
|
64
|
|
|
—
|
|
|
26,530
|
|
||||
Asset backed securities
|
7,204
|
|
|
14
|
|
|
—
|
|
|
7,218
|
|
||||
Total available-for-sale debt securities
|
$
|
47,947
|
|
|
$
|
78
|
|
|
$
|
—
|
|
|
$
|
48,025
|
|
|
|
|
Fair Value Measurements as of June 30, 2019 Using Inputs Considered as
|
||||||||||
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||
Commercial paper
|
$
|
14,277
|
|
|
—
|
|
|
14,277
|
|
|
$
|
—
|
|
Corporate debt
|
$
|
26,530
|
|
|
—
|
|
|
26,530
|
|
|
$
|
—
|
|
Asset backed securities
|
$
|
7,218
|
|
|
—
|
|
|
7,218
|
|
|
$
|
—
|
|
Mutual funds
|
$
|
410
|
|
|
121
|
|
|
289
|
|
|
$
|
—
|
|
Total marketable securities
|
$
|
48,435
|
|
|
121
|
|
|
48,314
|
|
|
$
|
—
|
|
|
|
|
Fair Value Measurements as of June 30, 2018 Using Inputs Considered as
|
||||||||||
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||
Mutual funds
|
$
|
544
|
|
|
199
|
|
|
345
|
|
|
$
|
—
|
|
Total marketable securities
|
$
|
544
|
|
|
199
|
|
|
345
|
|
|
$
|
—
|
|
|
Number of
Options
|
|
Weighted Average
Exercise Price
|
|||
Options outstanding at June 30, 2016
|
606,879
|
|
|
$
|
10.14
|
|
Exercised
|
(519,297
|
)
|
|
$
|
10.33
|
|
Forfeited or expired
|
(9,381
|
)
|
|
$
|
8.83
|
|
Options outstanding at June 30, 2017
|
78,201
|
|
|
$
|
9.07
|
|
Exercised
|
(55,880
|
)
|
|
$
|
9.20
|
|
Options outstanding at June 30, 2018
|
22,321
|
|
|
$
|
8.75
|
|
Exercised
|
(22,321
|
)
|
|
$
|
8.75
|
|
Options outstanding at June 30, 2019
|
—
|
|
|
$
|
—
|
|
|
Number of
Shares
|
|
Weighted Average
Grant Date
Fair Value
|
|||
Outstanding at June 30, 2016
|
647,573
|
|
|
$
|
23.24
|
|
Granted
|
258,346
|
|
|
$
|
21.80
|
|
Forfeited
|
(103,140
|
)
|
|
$
|
22.11
|
|
Vested
|
(316,195
|
)
|
|
$
|
24.21
|
|
Outstanding at June 30, 2017
|
486,584
|
|
|
$
|
21.26
|
|
Granted
|
290,856
|
|
|
$
|
27.93
|
|
Forfeited
|
(68,499
|
)
|
|
$
|
22.76
|
|
Vested
|
(253,725
|
)
|
|
$
|
22.87
|
|
Outstanding at June 30, 2018
|
455,216
|
|
|
$
|
24.77
|
|
Granted
|
262,727
|
|
|
$
|
35.53
|
|
Forfeited
|
(27,143
|
)
|
|
$
|
29.05
|
|
Vested
|
(215,855
|
)
|
|
$
|
23.23
|
|
Outstanding at June 30, 2019
|
474,945
|
|
|
$
|
31.36
|
|
Performance Measurement
|
|
2019
|
|
2018
|
|
2017
|
|||
Total shareholder return
|
|
225,325
|
|
|
278,889
|
|
|
336,826
|
|
|
Number of
Shares |
|
Weighted Average
Grant Date Fair Value |
|||
Outstanding at June 30, 2016
|
310,111
|
|
|
$
|
16.67
|
|
Granted
|
336,826
|
|
|
$
|
11.97
|
|
Forfeited
|
(328,353
|
)
|
|
$
|
16.41
|
|
Outstanding at June 30, 2017
|
318,584
|
|
|
$
|
11.97
|
|
Granted
|
278,889
|
|
|
$
|
13.63
|
|
Forfeited
|
(66,295
|
)
|
|
$
|
13.17
|
|
Outstanding at June 30, 2018
|
531,178
|
|
|
$
|
12.69
|
|
Granted
|
225,325
|
|
|
$
|
22.33
|
|
Forfeited
|
(2,631
|
)
|
|
$
|
18.64
|
|
Outstanding at June 30, 2019
|
753,872
|
|
|
$
|
15.20
|
|
|
Number of
Shares
|
|
Weighted Average
Grant Date
Fair Value
|
|||
Restricted stock units outstanding at June 30, 2016
|
304,816
|
|
|
$
|
13.95
|
|
Granted
|
54,064
|
|
|
$
|
21.21
|
|
Converted to common stock
|
(6,476
|
)
|
|
$
|
29.34
|
|
Forfeited
|
(2,974
|
)
|
|
$
|
21.01
|
|
Restricted stock units outstanding at June 30, 2017
|
349,430
|
|
|
$
|
14.73
|
|
Granted
|
28,364
|
|
|
$
|
31.02
|
|
Converted to common stock
|
(41,925
|
)
|
|
$
|
16.07
|
|
Restricted stock units outstanding at June 30, 2018
|
335,869
|
|
|
$
|
15.94
|
|
Granted
|
21,162
|
|
|
$
|
38.28
|
|
Converted to common stock
|
(2,855
|
)
|
|
$
|
21.01
|
|
Restricted stock units outstanding at June 30, 2019
|
354,176
|
|
|
$
|
17.23
|
|
Year Ended June 30, 2019
|
|
Restricted
Stock
Awards
|
|
Restricted
Stock
Units
|
|
Employee Stock Purchase Plan
|
|
Total
|
||||||||
Cost of goods sold
|
|
$
|
281
|
|
|
$
|
—
|
|
|
$
|
65
|
|
|
$
|
346
|
|
Selling, general and administrative
|
|
7,899
|
|
|
810
|
|
|
905
|
|
|
9,614
|
|
||||
Research and development
|
|
1,136
|
|
|
—
|
|
|
170
|
|
|
1,306
|
|
||||
Total stock-based compensation expense
|
|
$
|
9,316
|
|
|
$
|
810
|
|
|
$
|
1,140
|
|
|
$
|
11,266
|
|
Year Ended June 30, 2018
|
|
Restricted
Stock
Awards
|
|
Restricted
Stock
Units
|
|
Employee Stock Purchase Plan
|
|
Total
|
||||||||
Cost of goods sold
|
|
$
|
207
|
|
|
$
|
—
|
|
|
$
|
68
|
|
|
$
|
275
|
|
Selling, general and administrative
|
|
7,462
|
|
|
750
|
|
|
848
|
|
|
9,060
|
|
||||
Research and development
|
|
817
|
|
|
—
|
|
|
150
|
|
|
967
|
|
||||
Total stock-based compensation expense
|
|
$
|
8,486
|
|
|
$
|
750
|
|
|
$
|
1,066
|
|
|
$
|
10,302
|
|
Year Ended June 30, 2017
|
|
Restricted Stock Awards
|
|
Restricted
Stock
Units
|
|
Employee Stock Purchase Plan
|
|
Total
|
||||||||
Cost of goods sold
|
|
$
|
588
|
|
|
$
|
—
|
|
|
$
|
101
|
|
|
$
|
689
|
|
Selling, general and administrative
|
|
6,568
|
|
|
1,024
|
|
|
1,065
|
|
|
8,657
|
|
||||
Research and development
|
|
879
|
|
|
—
|
|
|
129
|
|
|
1,008
|
|
||||
Total stock-based compensation expense
|
|
$
|
8,035
|
|
|
$
|
1,024
|
|
|
$
|
1,295
|
|
|
$
|
10,354
|
|
|
June 30,
|
||||||
|
2019
|
|
2018
|
||||
Deferred tax assets
|
|
|
|
||||
Stock-based compensation
|
$
|
3,803
|
|
|
$
|
2,505
|
|
Deferred revenue
|
2,032
|
|
|
2,351
|
|
||
Accrued expenses and compensation
|
1,058
|
|
|
1,103
|
|
||
Other
|
1,062
|
|
|
1,022
|
|
||
Research and development credit carryforwards
|
5,161
|
|
|
5,048
|
|
||
Net operating loss carryforwards
|
65,628
|
|
|
64,101
|
|
||
Total deferred tax assets
|
78,744
|
|
|
76,130
|
|
||
Valuation allowance
|
(78,744
|
)
|
|
(76,130
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
Balances at June 30, 2016
|
$
|
101,217
|
|
Reductions
|
(186
|
)
|
|
Balance at June 30, 2017
|
101,031
|
|
|
Reductions
|
(24,901
|
)
|
|
Balance at June 30, 2018
|
76,130
|
|
|
Additions
|
2,614
|
|
|
Balance at June 30, 2019
|
$
|
78,744
|
|
Balances at June 30, 2016
|
$
|
545
|
|
Decreases related to prior year tax positions
|
(8
|
)
|
|
Increases related to current year tax positions
|
33
|
|
|
Balances at June 30, 2017
|
570
|
|
|
Decreases related to prior year tax positions
|
(3
|
)
|
|
Increases related to current year tax positions
|
30
|
|
|
Balance at June 30, 2018
|
597
|
|
|
Decreases related to prior year tax positions
|
(11
|
)
|
|
Increases related to current year tax positions
|
25
|
|
|
Balance at June 30, 2019
|
$
|
611
|
|
2020
|
$
|
392
|
|
2021
|
36
|
|
|
2022
|
8
|
|
|
2023
|
3
|
|
|
2024
|
2
|
|
|
Thereafter
|
—
|
|
|
|
$
|
441
|
|
|
Year Ended June 30,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Numerator
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
(255
|
)
|
|
$
|
1,712
|
|
|
$
|
(1,792
|
)
|
Income allocated to participating securities
|
—
|
|
|
(19
|
)
|
|
—
|
|
|||
Net income (loss) available to common stockholders
|
$
|
(255
|
)
|
|
$
|
1,693
|
|
|
$
|
(1,792
|
)
|
Denominator
|
|
|
|
|
|
||||||
Weighted average common shares outstanding — basic
|
33,535,759
|
|
|
33,145,140
|
|
|
32,373,709
|
|
|||
Effect of dilutive stock options(1)
|
—
|
|
|
15,039
|
|
|
—
|
|
|||
Effect of dilutive restricted stock units(2)
|
—
|
|
|
335,869
|
|
|
—
|
|
|||
Effect of performance-based restricted stock awards (3)
|
—
|
|
|
118,212
|
|
|
—
|
|
|||
Weighted average common shares outstanding — diluted
|
33,535,759
|
|
|
33,614,260
|
|
|
32,373,709
|
|
|||
|
|
|
|
|
|
||||||
Earnings per common share — basic
|
$
|
(0.01
|
)
|
|
$
|
0.05
|
|
|
$
|
(0.06
|
)
|
Earnings per common share — diluted
|
$
|
(0.01
|
)
|
|
$
|
0.05
|
|
|
$
|
(0.06
|
)
|
|
|
|
|
|
|
(1)
|
At June 30, 2018, and 2017; 22,321, and 78,201 stock options, respectively, were outstanding. The effect of the shares that would be issued upon exercise of these options has been excluded from the calculation of diluted loss per share as of June 30, 2019, and 2017, because those shares are anti-dilutive. No stock options were outstanding at June 30, 2019.
|
(2)
|
At June 30, 2019, 2018, and 2017; 354,176, 335,869 and 349,430 additional shares of common stock, respectively, were issuable upon the settlement of outstanding restricted stock units. The effect of the shares that would be issued upon settlement of these restricted stock units has been excluded from the calculation of diluted loss per share as of June 30, 2019, and 2017, because those shares are anti-dilutive.
|
(3)
|
At June 30, 2019, 2018, and 2017; 753,872, 531,178, and 318,584 respectively, of performance-based restricted stock awards were outstanding. The effect of the shares that would be issued upon vesting of these awards has been excluded from the calculation of diluted loss per share as of June 30, 2019, and 2017, because those shares are anti-dilutive.
|
|
2019
|
||||||||||||||||||
|
Q1
|
|
Q2
|
|
Q3
|
|
Q4
|
|
Year Total
|
||||||||||
Net revenue
|
$
|
56,266
|
|
|
$
|
60,206
|
|
|
$
|
63,311
|
|
|
$
|
68,234
|
|
|
$
|
248,017
|
|
Gross profit
|
$
|
45,691
|
|
|
$
|
48,729
|
|
|
$
|
51,145
|
|
|
$
|
54,772
|
|
|
$
|
200,337
|
|
Net income (loss)
|
$
|
(2,888
|
)
|
|
$
|
492
|
|
|
$
|
672
|
|
|
$
|
1,469
|
|
|
$
|
(255
|
)
|
Earnings per common share - basic(1)
|
$
|
(0.09
|
)
|
|
$
|
0.01
|
|
|
$
|
0.02
|
|
|
$
|
0.04
|
|
|
$
|
(0.01
|
)
|
Earnings per common share - diluted(1)
|
$
|
(0.09
|
)
|
|
$
|
0.01
|
|
|
$
|
0.02
|
|
|
$
|
0.04
|
|
|
$
|
(0.01
|
)
|
|
2018
|
||||||||||||||||||
|
Q1
|
|
Q2
|
|
Q3
|
|
Q4
|
|
Year Total
|
||||||||||
Net revenue
|
$
|
49,676
|
|
|
$
|
52,628
|
|
|
$
|
55,587
|
|
|
$
|
59,152
|
|
|
$
|
217,043
|
|
Gross profit
|
$
|
40,474
|
|
|
$
|
43,129
|
|
|
$
|
45,618
|
|
|
$
|
48,338
|
|
|
$
|
177,559
|
|
Net income (loss)
|
$
|
(1,977
|
)
|
|
$
|
(413
|
)
|
|
$
|
365
|
|
|
$
|
3,737
|
|
|
$
|
1,712
|
|
Earnings per common share - basic(1)
|
$
|
(0.06
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
0.01
|
|
|
$
|
0.11
|
|
|
$
|
0.05
|
|
Earnings per common share - diluted(1)
|
$
|
(0.06
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
0.01
|
|
|
$
|
0.11
|
|
|
$
|
0.05
|
|
(1)
|
Financial Statements. The following financial statements are included in Part II, Item 8 of this Annual Report on Form 10-K:
|
•
|
Report of Independent Registered Public Accounting Firm
|
•
|
Consolidated Balance Sheets as of June 30, 2019 and 2018
|
•
|
Consolidated Statements of Operations for the years ended June 30, 2019, 2018 and 2017
|
•
|
Consolidated Statements of Comprehensive Income for the years ended June 30, 2019, 2018 and 2017
|
•
|
Consolidated Statements of Changes in Stockholders’ Equity for the years ended June 30, 2019, 2018 and 2017
|
•
|
Consolidated Statements of Cash Flows for the years ended June 30, 2019, 2018 and 2017
|
•
|
Notes to Consolidated Financial Statements
|
•
|
All financial statement schedules have been omitted, because they are not applicable, are not required, or the information is included in the Financial Statements or Notes thereto
|
Exhibit
No.
|
|
Description
|
3.1
|
|
|
3.2
|
|
|
4.1
|
|
|
4.2
|
|
|
4.3*
|
|
|
10.1†
|
|
|
10.2†*
|
|
|
10.3†*
|
|
|
10.4†
|
|
|
10.5
|
|
|
10.6
|
|
|
10.7+
|
|
|
10.8†
|
|
|
10.9†
|
|
|
10.10†
|
|
10.11†
|
|
|
10.12†
|
|
|
10.13†
|
|
|
10.14†
|
|
|
10.15†
|
|
|
10.16
|
|
|
10.17+
|
|
|
10.18
|
|
|
10.19
|
|
|
10.20†
|
|
|
10.21†
|
|
|
10.22†
|
|
|
10.23
|
|
|
10.24
|
|
|
10.25†
|
|
|
10.26†
|
|
|
10.27†
|
|
|
10.28†
|
|
|
10.29†
|
|
|
10.30†
|
|
10.31†
|
|
|
10.32†
|
|
|
10.33†
|
|
|
10.34+
|
|
|
10.35
|
|
|
10.36†
|
|
|
10.37†
|
|
|
10.38
|
|
|
10.39†
|
|
|
23.1*
|
|
|
24.1*
|
|
|
31.1*
|
|
|
31.2*
|
|
|
32.1**
|
|
|
32.2**
|
|
|
101**
|
|
Financial statements from the Annual Report on Form 10-K of the Company for the year ended June 30, 2019, formatted, in Extensible Business Reporting Language (XBRL): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations, (iii) the Consolidated Statements of Comprehensive Income, (iv) the Consolidated Statements of Changes in Stockholders’ Equity, (v) the Consolidated Statements of Cash Flows, and (vi) the Notes to Consolidated Financial Statements.
|
+
|
Confidential treatment has been granted for certain portions omitted from this exhibit pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
|
|
CARDIOVASCULAR SYSTEMS, INC.
|
||
|
|
|
|
Date: August 22, 2019
|
By:
|
|
/s/ Scott R. Ward
|
|
|
|
Scott R. Ward
|
|
|
|
Chairman, President and Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
||
/s/ Scott R. Ward
|
|
Chairman, President and Chief Executive Officer (principal executive officer)
|
|
August 22, 2019
|
Scott R. Ward
|
|
|
||
|
|
|
||
/s/ Jeffrey S. Points
|
|
Chief Financial Officer (principal financial and accounting officer)
|
|
August 22, 2019
|
Jeffrey S. Points
|
|
|
||
|
|
|
||
/s/ Martha Goldberg Aronson
|
|
Director
|
|
August 22, 2019
|
Martha Goldberg Aronson
|
|
|
||
|
|
|
||
/s/ Brent G. Blackey
|
|
Director
|
|
August 22, 2019
|
Brent G. Blackey
|
|
|
||
|
|
|
||
/s/ Edward Brown
|
|
Director
|
|
August 22, 2019
|
Edward Brown
|
|
|
||
|
|
|
||
/s/ William E. Cohn
|
|
Director
|
|
August 22, 2019
|
William E. Cohn
|
|
|
||
|
|
|
||
/s/ Augustine Lawlor
|
|
Director
|
|
August 22, 2019
|
Augustine Lawlor
|
|
|
||
|
|
|
||
/s/ Erik Paulsen
|
|
Director
|
|
August 22, 2019
|
Erik Paulsen
|
|
|
||
|
|
|
•
|
special meetings of stockholders may be called only by the Chairman of the Board, the Chief Executive Officer, or by a majority of the Board of Directors;
|
•
|
the Board of Directors is a classified board, with three separate classes of directors each serving a three-year term;
|
•
|
only business brought before an annual meeting by the Board of Directors or by a stockholder who complies with the procedures set forth in the Amended and Restated Bylaws may be transacted at an annual meeting of stockholders;
|
•
|
advance notice is required for specified stockholder actions, such as the nomination of directors and stockholder proposals; and
|
•
|
the Company may issue, without stockholder approval, up to 5,000,000 shares of preferred stock that could adversely affect the rights and powers of the holders of our common stock.
|
●
|
|
|
Retainers of $45,000 for service as a Board member; $22,000 for service as the chair of the Audit committee; $20,000 for service as a chair of a Board committee other than the Audit committee; $10,000 for service as a member of a Board committee; and $1,200 per Board or committee meeting attended in the event that more than 12 of such meetings are held during the period. Directors may irrevocably elect, in advance of the fiscal year, to receive these fees in cash, in common stock of the Company or a combination thereof, or in restricted stock units (“RSUs”). Each director electing to receive fees in RSUs shall at the time of such election also irrevocably select the date of settlement of the RSU. On the settlement date, RSUs may be settled, at the Company’s discretion, in cash or in shares of common stock or a combination thereof.
|
●
|
|
|
An RSU award with a value of $145,000 payable, in the Company’s discretion, in cash or in shares of common stock. The Company will provide for the RSU payment, whether paid in cash or shares of common stock, to be made (in a lump sum if paid in cash) within 30 days following the six-month anniversary of the termination of the director’s Board membership.
|
1.
|
I have reviewed this annual report on Form 10-K of Cardiovascular Systems, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ Scott R. Ward
|
Scott R. Ward
Chairman, President and Chief Executive Officer
|
1.
|
I have reviewed this annual report on Form 10-K of Cardiovascular Systems, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ Jeffrey S. Points
|
Jeffrey S. Points
Chief Financial Officer
|
/s/ Scott R. Ward
|
Scott R. Ward
Chairman, President and Chief Executive Officer
|
By: /s/ Jeffrey S. Points
|
Jeffrey S. Points
|
Chief Financial Officer
|