Attached files

file filename
EX-23.1 - EX-23.1 - EXACTECH INCexac-ex231_328.htm
EX-21.1 - EX-21.1 - EXACTECH INCexac-ex211_329.htm
EX-31.1 - EX-31.1 - EXACTECH INCexac-ex311_327.htm
EX-32.2 - EX-32.2 - EXACTECH INCexac-ex322_325.htm
EX-32.1 - EX-32.1 - EXACTECH INCexac-ex321_324.htm
EX-31.2 - EX-31.2 - EXACTECH INCexac-ex312_326.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-K

 

x

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2015

o

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from       to      

Commission File Number 0-28240

 

EXACTECH, INC.

(Exact name of registrant as specified in its charter)

 

 

FLORIDA

 

59-2603930

 

 

 

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification No.)

2320 NW 66TH COURT, GAINESVILLE, FL, 32653

(Address of principal executive offices)

(352) 377-1140

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

 

(Title of each class)

 

(Name of each exchange on which registered)

 

 

 

Common Stock, $0.01 par value per share

Common Stock Purchase Rights

 

NASDAQ Global Select Market

Securities registered pursuant to Section 12(g) of the Act:

None.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Act.     Yes  ¨    No  ý

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes  ¨    No  ý

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ý    No  ¨

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  ý

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ý    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer," "accelerated filer”, and "smaller reporting company" in Rule 12b-2 of the Exchange Act.

Large Accelerated Filer

o

Accelerated Filer

x

Non-Accelerated Filer

o

Smaller Reporting Company

o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes  ¨    No  ý

As of February 26, 2016, the number of shares of the registrant’s Common Stock outstanding was 14,027,809. The aggregate market value of our Common Stock held by non-affiliates as of June 30, 2015 was approximately $214,994,762 based on a closing sale price of $20.83 for Common Stock as reported on the NASDAQ Global Market on such date. For purposes of the foregoing computation, all of our executive officers, directors and five percent beneficial owners are deemed to be affiliates. Such determination is not an admission that such executive officers, directors or five percent beneficial owners are, in fact, our affiliates.

DOCUMENTS INCORPORATED BY REFERENCE

The information required by Part III (Items 10, 11, 12, 13, and 14) is incorporated by reference to the registrant’s definitive proxy statement for its 2016 Annual Meeting of Shareholders (to be filed pursuant to Regulation 14A).

 


 

EXACTECH, INC.

INDEX

 

 

 

 

 

Page

Number

PART I.

 

 

 

 

 

 

 

 

 

Item 1.

 

Business

 

2

Item 1A.

 

Risk Factors

 

14

Item 1B.

 

Unresolved Staff Comments

 

26

Item 2.

 

Properties

 

26

Item 3.

 

Legal Proceedings

 

27

Item 4.

 

Mine Safety Disclosures

 

27

 

 

 

 

 

PART II.

 

 

 

 

Item 5.

 

Market for Registrant's Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities

 

28

Item 6.

 

Selected Financial Data

 

30

Item 7.

 

Management's Discussion and Analysis of Financial Condition and Results of Operations

 

31

Item 7A.

 

Quantitative and Qualitative Disclosures About Market Risk

 

42

Item 8.

 

Financial Statements and Supplementary Data

 

43

Item 9.

 

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

 

70

Item 9A.

 

Controls and Procedures

 

70

 

 

Management's Report on Internal Control Over Financial Reporting

 

70

 

 

Report of Independent Registered Public Accounting Firm

 

71

Item 9B.

 

Other Information

 

71

 

 

 

 

 

PART III.

 

 

 

 

Item 10.

 

Directors, Executive Officers and Corporate Governance

 

72

Item 11.

 

Executive Compensation

 

72

Item 12.

 

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 

72

Item 13.

 

Certain Relationships and Related Transactions and Director Independence

 

72

Item 14.

 

Principal Accountant Fees and Services

 

72

 

 

 

 

 

PART IV.

 

 

 

 

Item 15.

 

Exhibits and Financial Statement Schedules

 

73

 


 

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

We are making this statement pursuant to the safe harbor provisions for forward-looking statements described in the Private Securities Litigation Reform Act of 1995.  This report contains forward-looking statements, which are not historical facts but are our intents, beliefs, or current expectations of our business and industry.  When used in this report or in any other presentation, statements which are not historical in nature, which can be identified by words including “anticipate,” “estimate,” “could,” “should,” “may,” “plan,” “seek,” “expect,” “believe,” “intend,” “target,” “project” and similar expressions, are intended to identify forward-looking statements.  They also include statements regarding:

 

·

our future growth and profitability;

 

·

our competitive strengths; and

 

·

our business strategy and the trends we anticipate in the industries and economies in which we operate.

These forward-looking statements are based on our current expectations and are subject to a number of risks, uncertainties and assumptions.  These statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond our control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements.  Important factors that could cause actual results to differ materially from those in forward-looking statements include:

 

·

economic downturns, reduced capital expenditures, consolidation and technological and regulatory changes in the industries we serve;

 

·

the highly competitive nature of our industry;

 

·

our ability to attract and retain qualified managers and skilled employees;

 

·

the outcome of our plans for future operations and growth; and

 

·

the other factors referenced in this report, including, without limitation, under “Risk Factors.”

We believe these forward-looking statements are reasonable; however, you should not place undue reliance on any forward-looking statements, which are based on current expectations.  Furthermore, forward-looking statements speak only as of the date they are made.  If any of these risks or uncertainties materialize, or if any of our underlying assumptions are incorrect, our actual results may differ significantly from the results that we express in or imply by any of our forward-looking statements.  These and other risks are detailed in this report, in the documents that we incorporate by reference into this report and in other documents that we file with the Securities and Exchange Commission.  We do not undertake any obligation to publicly update or revise these forward-looking statements after the date of this report to reflect future events or circumstances, except to the extent required by applicable law.  We qualify any and all of our forward-looking statements by these cautionary factors.  Except where the context otherwise requires, the terms "Company", "Exactech", “we”, “our”, or “us” refer to the business of Exactech, Inc. and its consolidated subsidiaries.

 

 

 

 


 

ITEM 1.

BUSINESS 

We develop, manufacture, market, distribute and sell orthopaedic implant devices, related surgical instrumentation and biologic services to hospitals and physicians in the United States and internationally.  Exactech was founded by an orthopaedic surgeon in November 1985, and is incorporated under the laws of the State of Florida. Our U.S. sales and distribution activities are conducted by our wholly owned subsidiary Exactech U.S., Inc. Our international development, sales and distribution activities are conducted by our wholly owned subsidiary Exactech International Operations, AG based in Bern, Switzerland. Our revenues are principally derived from sales and distribution of our joint replacement systems, including knee, hip, spine, and extremity implant systems, and distribution of biologic products and services and bone cement materials used in orthopaedic surgery and dental procedures.

We manufacture some components of our knee, extremity, and hip joint replacement systems at our facility in Gainesville, Florida, utilizing modern, highly automated computer aided manufacturing equipment.  Our cell-based manufacturing processes, which are organized in groups, or cells, are dedicated to specific product lines to minimize change-over and increase efficiency, and are designed to help us reduce our production cycle times while permitting flexibility to adjust quickly to changes in demand.  To supplement our manufacturing of components, we have formed strategic alliances with suppliers and business partners to externally manufacture some components.  Additionally, we acquire and distribute other products and services through exclusive agreements, such as our agreement with Tecres® S.p.A, (Tecres), and non-exclusive agreements, such as with RTI Surgical, Inc., (RTI), and Biomatlante SARL, (Biomatlante).

Orthopaedic Products Industry

According to a research report published in 2015 by Orthoworld, Inc., the worldwide market for orthopaedic products in 2014 was estimated to be nearly $45.5 billion, which represented an increase of 3% from the previous year. According to this study, the three primary market segments in which we offer our products and services, reconstructive devices, orthobiologics and other products (which includes instrumentation and other orthopaedic products), were estimated to be $15.4 billion, $4.4 billion and $5.9 billion, respectively, during 2014. This study also estimates that the spinal implant/instrumentation market was $8.2 billion during 2014.  According to this report, demographics, including an aging, population, will continue to drive growth in the global orthopaedic marketplace. Management continues to believe that the industry will continue to grow due to an aging population in much of the world.  Increasing life spans and lifestyles impact the number of individuals with joints subject to failure, thereby increasing demand for joint replacement procedures.

Products

Our joint replacement products are used by orthopaedic surgeons to repair or replace joints that have deteriorated as a result of injury or disease. Reconstructive joint surgery involves modification of the area surrounding the affected joint and insertion of a set of manufactured implant components to replace or augment the joint. During surgery, the surgeon removes damaged cartilage and a portion of the bones that comprise the joint, prepares the remaining bone surfaces and surrounding tissue and then installs the implant. When necessary, the surgeon uses biologic allograft services, like those services we distribute, to repair bone defects and provide an environment to stimulate new bone growth. In many joint replacement procedures, acrylic bone cement is used to affix implant components to the prepared bone surfaces.

Spinal implants are used as an adjunct to the fusion of vertebrae in the treatment of spinal disease and deformity.  Indications for spinal surgery include genetic reasons, trauma, or degeneration. Spinal surgery is performed to remove bone and/or other tissue from the spinal column to restore stability and alleviate pain. Metal rods, screws and plates are used to stabilize two or more vertebrae in order to promote fusion of a portion of the spinal column, thereby eliminating irregular motion that can cause pain due to nerve root impingement, and damage tissue. Biologic allograft services can be one of the treatments used in conjunction with the other implants to enhance the potential for a successful result.

2


 

The following table includes the net revenue and percentage of net revenue for each of our product lines, which are also our reportable segments, for the years ended December 31, 2015, 2014 and 2013.  Other financial information relating to our reportable segments is included in Note 13 of our Consolidated Financial Statements, in Part II Item 8.  - Financial Statements and Supplementary Data of this Annual Report on Form 10-K.  

 

Sales by Product Line

($ in 000’s)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended

 

 

 

December 31, 2015

 

 

December 31, 2014

 

 

December 31, 2013

 

Extremity

 

$

84,418

 

 

 

34.9

%

 

$

79,003

 

 

 

31.8

%

 

$

65,528

 

 

 

27.6

%

Knee

 

 

70,865

 

 

 

29.3

 

 

 

78,678

 

 

 

31.7

 

 

 

80,532

 

 

 

34.0

 

Hip

 

 

42,655

 

 

 

17.6

 

 

 

43,491

 

 

 

17.5

 

 

 

40,958

 

 

 

17.3

 

Biologics and Spine

 

 

22,619

 

 

 

9.4

 

 

 

23,826

 

 

 

9.6

 

 

 

25,486

 

 

 

10.7

 

Other

 

 

21,281

 

 

 

8.8

 

 

 

23,375

 

 

 

9.4

 

 

 

24,584

 

 

 

10.4

 

Total

 

$

241,838

 

 

 

100.0

%

 

$

248,373

 

 

 

100.0

%

 

$

237,088

 

 

 

100.0

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Extremities Products. The Equinoxe® Platform Shoulder System continues to be one of the fastest growing shoulders on the market by delivering clinically relevant solutions with streamlined instrumentation. The product family includes treatment options for both degenerative disease (primary and reverse total shoulder systems) as well as trauma (platform fracture stem and fracture plate).

Our primary system utilizes a patented replicator plate, which allows for independent adjustment of all four anatomic parameters in situ (assembled inside the body). The Equinoxe is a platform system, convertible to a reverse without removal of a well-fixed stem. In keeping with our philosophy of delivering clinical results, a multicenter study found that, compared to our competitors, our reverse shoulder achieved a sevenfold reduction in scapular notching, which is one of the main complications of the procedure.

We offer unique bone preserving glenoid solutions that further differentiate our system, including our newest option – the superior/posterior augment baseplate.

In 2014, we launched the resurfacing humeral head in the United States and expanded that launch globally in 2015. Also in 2015, we began implanting the Humeral Reconstruction Stem, which is a specialized solution for oncology and revision settings.  This stem, when combined with our reverse components, offers surgeons the only reverse solution for patients with massive bone loss in the proximal humerus.

We also provide innovative solutions for shoulders with traumatic injuries. Our fracture plate and platform fracture stem enable surgeons to inter-operatively choose which solution is best for the patient.  Having a platform capability on a fracture stem is critical because fracture stems are typically cemented and converting a hemi-arthroplasty (involving only the humeral component, as opposed to a Total Shoulder, which replaces the humeral head and glenoid) to a reverse without removing a cemented stem is significantly better for the patient and surgeon.

Knee Products.  The Exactech Knee System provides comprehensive solutions for partial, primary and revision total knee arthroplasty. With its clinically proven implant design, proprietary materials, intuitive instrumentation and advanced technology, the system empowers orthopaedic surgeons to personalize their workflow and manage a wide variety of clinical challenges for reproducible results, case after case.

All of our knee implant systems feature design elements that have been proven for more than four decades, as well as proprietary, net compression molded polyethylene inserts, which are designed to minimize surface damage and wear rates, and ultimately improve the longevity of the knee prosthesis.

For primary knee replacement, the Optetrak Logic® system offers implant solutions for both posterior stabilized, or PS, and cruciate retaining, or CR, approaches. The bone-preserving PS system is designed to maximize stability and range of motion while providing surgeons an easier, faster and more consistent notch preparation. The CR system enables surgeons to plan and perform total knee replacement based on the anatomical and functional integrity of the posterior cruciate ligament; the system features a unique Posterior Cruciate Referencing Technique (PCRT) and CR Slope® technology. The portfolio also offers two constrained inserts, PSC and CRC, to allow surgeons to easily transition to increased constraint without additional bone preparation, and for surgeons

3


 

who prefer a non-cemented option, a press-fit femoral component with a unique 3-D structural lattice of irregular shaped particles is available.

In order to better meet the demand for revision surgeries, we began our initial launch of a new revision knee system in 2015. The comprehensive system offers implant choices orthopaedic surgeons need to address the unique challenges in revision knee arthroplasty, and the system additionally provides an efficient approach to aligning components to deliver reproducibility using a more streamlined technique. This new and improved system incorporates the clinically proven design philosophies found in the primary system, and its intuitive instrumentation features easy-to-read laser markings, which are designed to provide surgeons with visual, audible and tactile feedback throughout each case.

We provide a comprehensive range of advanced instrumentation options, including low profile instrumentation (LPI®), patella preparation, posterior referencing and a ligament balancing system (LBSIII). For advanced technology, we launched V2 of ExactechGPS® Guided Personalized Surgery, a powerful, yet compact computer-assisted surgery system that delivers efficiency and reproducibility in total joint replacement. The next generation features a new tablet-sized computer and touch screen unit, merging sophisticated technology with innovative instrumentation to offer a real-time, patient-specific solution for improved patient outcomes.

We also continue to support our classic Optetrak® knee system, a cruciate ligament sparing, posterior stabilized and a high flexion component, a unicondylar system and a constrained condylar design for revision surgery. Internationally, we continue our expansion of the Optetrak Logic system including the rotating bearing knee system–Optetrak Logic RBK®.

Hip Products.  Our hip solutions address the continuum of hip arthroplasty. For primary hip reconstruction, the Novation® system features both splined and tapered press-fit femoral stems as well as collared, matte finish cemented stems. The Novation CFS® cemented and press-fit femoral components, as well as unipolar and bipolar endoprostheses, are often used for the treatment of hip fractures as well as for complex primary hip surgery. They use the same core instruments that support Novation tapered and splined preparation, which allows for simple preparation and utilization of the same instrumentation for both low- and high-demand stems.

We expanded our hip portfolio with the introduction of the Alteon® brand, and now encompasses two new femoral solutions-the Tapered Wedge Femoral Stem and Neck Preserving Femoral Stem. The Tapered Wedge is a single taper, wedge-style stem. It incorporates specific design features to achieve immediate axial and rotational mechanical stability between the medial and lateral cortices of the femoral canal. The Neck Preserving Stem is a short femoral stem that shares the proven features of conventional stems, but designed to conserve more bone. These two stems share a set of core femoral instruments, allowing for an easier transition and reduced instrumentation in the operating room.

Our Novation Element® wedge stem features Exactech's signature neck geometry and is designed to provide surgeons with excellent initial stability and long-term fixation when paired with our standard instrumentation or A+ Instrumentation™ for the direct anterior approach.

The Crown Cup® acetabular system for primary, complex primary and revision hip arthroplasties features our third generation porous material, InteGrip™, which is manufactured with a titanium alloy through a unique manufacturing method known as Electron Beam Melting. Exactech was the first U.S. orthopaedic device company to offer FDA-cleared orthopaedic implants manufactured through this proprietary process.  Crown Cup also features GXL polyethylene liners, which minimize wear debris. The Novation ceramic AHS® Crown Cup is designed to minimize osteolysis by utilizing an alumina ceramic bearing that provides significantly lower wear debris generation over traditional bearing surfaces.

For revision surgeries, the AcuMatch® M-Series modular femoral stem offers components that are 100% interchangeable, allowing the surgeon to customize the prosthesis at the time of surgery and according to the patient's bony structures. This versatility and the manner in which the components mate can have a positive effect on patient outcomes.

In 2015, Exactech launched the Alteon Monobloc Revision Stem. This stem is a press-fit, distally fixed, one-piece tapered, splined titanium stem. It incorporates specific philosophies designed to improve surgical experiences and clinical outcomes. The Monobloc Revision Femoral Stem intends to achieve axial and rotational mechanical stability and operative predictability through a carefully engineered combination of design features.

4


 

Biologics and Spine.  We manufacture and distribute various products and services designed for the healing and regeneration of bone and soft tissue, including products which contain human allograft.  We have maintained a distribution relationship with RTI since 1998 for the marketing of its Opteform® and Optefil® product lines of Demineralized Bone Matrix.

Additionally, we market a platform of Demineralized Bone Matrix products, under the brand name Optecure®.  The product also contains a synthetic bioabsorbable polymer carrier material initially licensed from Genzyme Corp. Additionally, a product line extension was introduced to the Optecure brand that combines Demineralized Bone Matrix with additional allograft product within the formulation (Optecure®+CCC).  We market OpteMx®, a Tri-Calcium Phosphate/Hydroxyapatite based synthetic bone graft substitute, licensed under a non-exclusive U.S. distribution agreement with Biomatlante.

Accelerate® is a platelet concentrating system that offers high platelet yields through gentle centrifugal action, which preserves the fragile buffycoat layer. This easy-to-use system provides a fast and convenient method for processing PRP at the point of care from a small amount of patient’s blood (PRP/PRP-S systems) or concentrating cells at the point of care from a patient’s bone marrow (BMC system).

We also distribute Ossigen®, a 3D matrix of collagen and an organic bone mineral processed into blocks for surgical implantation for the repair of bony defects in the spine, extremities and pelvis that may be hydrated with autogenous bone marrow at the point of use.

Our Spine Division is focused on the development and commercialization of products intended to stabilize spinal motion segments for the purpose of promoting spinal fusion. The Proliant® Pedicle Screw System is designed to provide secure fixation of the thoracolumbar spine while offering surgeons improved speed and ease-of-use. The pedicle screw has a dual lead thread for faster insertion and patented Tightlok® thread pattern that is designed to reduce screw pull out and facilitate fusion. The EZ Set tulip head allows the surgeon to easily position and set the tulip head in any position for rod insertion.

The Gibralt cervical thoracic spine system is a versatile solution that features top-loading polyaxial screws with an EZ Set tulip head and Tightlok thread technology. The system includes hooks, offset connectors and rod-to-rod connectors which can be constructed into a multitude of configurations based on individual patient anatomy. The Gibralt® Spinal System includes the Gibralt Occipital Plate, a comprehensive solution for posterior stabilization and fusion of the cervical and thoracic spine. Gibralt works in conjunction with our Proliant and HydraLok pedicle screw systems for a full spine solution.

Octane® Straight is a PEEK Interbody Spacer System that provides two different implant options to accommodate a traditional straight spacer insertion or a less invasive insert-and-rotate technique. The devices are manufactured from a Biocompatible PEEK-Optima® polymer with radiographic markers, which allows for visualization of the implant with a clear assessment of the fusion. In addition, multiple footprints allow for different approach options: Bilateral posterior approach using 24mm spacers, or unilateral posterior approach using 28mm and 32mm spacers. During 2014, we launched Octane M, a new design of interbody fusion implant which allows atraumatic entry to its final position between two vertebral bodies.

These products complement our existing spine line, help us expand into other growing spine market segments and provide our customers additional options to improve patient care.

Other Products. The Cemex® bone cement system features a unique, self-contained delivery system that has been clinically proven in Europe for more than two decades.  By integrating bone cement powder and liquid into an enclosed mixing system, Cemex is designed to offer surgeons and operating room personnel simplicity, safety and reliability. Product offerings include Cemex Genta, a bone cement containing antibiotics and Cemex Fast, a quick-set cement, with or without antibiotic. The InterSpace® hip, knee and shoulder spacers are used in two stage revision procedures and provide orthopaedic surgeons with a unique and convenient way to treat this difficult problem, including a high release antibiotic version of the InterSpace hip, knee and shoulder spacers. We distribute Cemex in the United States and Canada under an exclusive distribution agreement with the Italian manufacturer, Tecres.

The AcuDriver® Automated Osteotome System is an air-driven impact handpiece that surgeons can use during joint implant revision procedures to effectively remove failed prostheses and bone cement. The AcuDriver accomplishes this by providing the surgeon with precise positioning without the inconvenience and inconsistency of striking the osteotome, a cement removal tool, with a mallet.

5


 

Marketing and Sales

We market our orthopaedic implant products in the United States through Exactech U.S., Inc., which operates through a network of independent sales agencies and direct sales representatives. These organizations, along with their independently contracted personnel, serve as our sales representatives.  Internationally, Exactech International Operations markets our products through a network of independent distributors and our wholly owned foreign subsidiaries that distribute products and services in more than 35 countries. The customers for our products are hospitals, surgeons and other physicians and clinics.

We generally have contractual arrangements with our independent sales organizations that grant the exclusive right to sell our products in a specified territory.  In turn, we require that the sales organizations meet certain sales quotas. We typically pay our sales agencies a commission based on net sales.  We are highly dependent on the expertise and customer service effectiveness of our independent sales force. Our U.S. sales organization is managed by Regional Vice Presidents of Sales who are assigned to regions throughout the United States. We currently offer our products in all fifty states, Puerto Rico, and the District of Columbia. Our international subsidiaries purchase inventory from Exactech International Operations, our international headquarters, and utilize a network of employees and independent sales representatives to distribute our products and services in their respective territories outside the United States.

We provide our U.S. sales organizations inventories of our products, which remain in their possession until sold or returned to us.  These inventories are necessary for sales representatives to market our products and fill customer orders.  Because the size of a particular component for a specific patient is typically not known with certainty until the time of surgery, a minimum of one of each size of each component in the system to be used must be available to the surgeon at the time of each particular surgery.  Accordingly, we must incur significant expenditures in order to maintain the necessary levels of inventory.  Our failure to maintain required levels of inventory could have a material adverse effect on our operations.  Because we must maintain substantial levels of inventory, we are subject to the risk of inventory obsolescence.  In the event that a substantial portion of our inventory becomes obsolete, it would have a material adverse effect on our results of operations and liquidity.  We review our inventory for obsolescence on a regular basis and record an allowance to reduce the carrying value of our inventory when necessary.

Similar to the U.S. operations, we generally have contractual arrangements with our international distributors that grant them the exclusive right to market our products in a specified territory, and we require that these distributors meet certain sales quotas.  International distributors typically purchase product inventory and instruments from us for their use in marketing, consigning inventory for surgery, and filling customer orders.  We have wholly owned subsidiaries operating in China, France, Japan, Spain, Germany, Taiwan, Switzerland, and the United Kingdom, and a branch office in Canada.

Financial Information about Geographic Areas

For the years ended December 31, 2015, 2014, and 2013, international sales accounted for $73.7 million, $82.8 million, and $77.4 million, respectively, representing approximately 30%, 33% and 33%, respectively, of our net sales. We intend to continue to work to expand our sales in international markets in which there is increasing demand for orthopaedic implant products. We anticipate increasing our reliance on direct sales efforts through subsidiaries. Total inventory and long-lived assets held outside the United States as of December 31, 2015 and 2014 was $71.2 million and $61.0 million, respectively.

Manufacturing and Supply

Early in our history, third-party vendors manufactured all of our component parts, while we internally performed product design, quality assurance and packaging.  For the past fifteen years, our strategy has been to develop and expand our own internal manufacturing and supply chain capabilities.  We have done this through strategically creating state-of-the-art cell-based manufacturing processing, and utilizing highly automated, computer-aided production and inspection equipment.

Our manufacturing process typically involves the final machining of semi-completed raw materials of both our metal and polyethylene, or compression molded plastic, components that make up our joint replacement systems.  After parts are machined, they are inspected and processed for final polishing and finishing as needed.  Prior to packaging, our parts are inspected again to ensure that they are within approved specifications.  Packaged

6


 

finished parts are then made sterile and ready for surgery through gamma irradiation performed by an outside vendor.

We currently manufacture approximately 66% of our knee, hip, and shoulder implant components at our facility and headquarters in Gainesville, Florida, as compared to 60% in 2014.  With the increase of internal manufacturing, we have experienced a greater degree of control in reducing production costs, while improving response time, flexibility, and other time-saving activities related to continuous process improvement, and we expect this trend to continue.  We also continually assess the quality, manufacturing capabilities, on time delivery and cost-effectiveness of our existing and potential vendors in an attempt to secure our supply chain and decrease dependency on key suppliers.  For the years ended December 31, 2015, 2014 and 2013, we purchased approximately 23%, 24% and 24%, respectively, of our externally sourced component requirements from our top three suppliers. We typically do not maintain supply contracts with most of our manufacturers and we instead purchase components pursuant to purchase orders placed from time to time in the ordinary course of business.  We continue to develop alternative sources for components.  While we do not anticipate encountering difficulties in obtaining adequate supplies of components, we cannot provide assurance that we will continue to be able to obtain components under acceptable terms and in a timely manner.  Order backlog is not a material aspect of our business.

Our internal manufacturing, assembly, packaging and quality control operations are conducted at our principal offices in Gainesville, Florida.  Components received from suppliers, as well as those internally manufactured, are examined by our own personnel and prior to assembly or packaging to ensure that our specifications and standards are maintained.

Additionally, in two leased properties in Sarasota, Florida, we produce our net compression molded polyethylene bearings used in our Optetrak knee replacement system, as well as other instrument and implant components. These facilities are included in our ISO 13485:2003 certification.

Patents and Proprietary Technology; License and Consulting Agreements

We hold U.S. and international patents covering several of our implant components, biologic materials technologies and some of our surgical instrumentation with lives ranging from five to seventeen years.  We believe that patents and intellectual property will continue to be important to our business and in the orthopaedic industry overall.  In this regard, we defend our intellectual property rights and believe that our patents and products do not and will not infringe patents or violate proprietary rights of others, however, it is possible that our existing patent rights may not be valid or that infringement of existing or future patents or proprietary rights may occur.  If some of our intellectual property and/or agreements relating to our products were deemed invalid, then such invalidation could have a material adverse effect on our financial condition and results of operations.

In connection with the development of our knee implant systems, we pay royalties to Dr. William Petty and Dr. Gary Miller, who are executive officers and principal shareholders of the Company.  Dr. Petty also serves as the Chairman of our Board of Directors.  Employment agreements entered into between us and each of Drs. Petty and Miller provide for the continuation of the royalty payments in addition to their regular compensation as executive officers.  During the year ended December 31, 2015, we paid royalties in the aggregate of $300,000, pursuant to these consulting agreements.

We also pay royalties to a significant hospital customer, under a license agreement, pursuant to which this customer assists with the development and promotion of our knee implant systems as well as with training persons in the use of such systems.

We have an oral consulting agreement with our former director, Albert Burstein, Ph.D., pursuant to which he provides services regarding many facets of the orthopaedic industry, including product design rationale, manufacturing and development techniques and product sales and marketing.  During 2015, we paid Dr. Burstein $180,000 as compensation under this consulting agreement. See Note 7 to Notes to our Consolidated Financial Statements for further discussion on related party transactions.  

Research and Development

During 2015, 2014 and 2013, we expended $19.4 million, $18.4 million, and $17.8 million, respectively, on research and development, and we anticipate that research and development expenses will continue to increase.  Our research and development efforts contributed to the successful release of product line extensions to the

7


 

Novation and Alteon hip stem systems, Equinoxe shoulder systems, and the Optetrak knee system, and numerous new spine products, as well as design improvements targeted to improving internal manufacturing efficiency.  Our research and development efforts continue to focus on implant product line extensions, advanced biologic materials, extremity joint reconstruction and spinal product development.

As an important part of our research and development efforts to improve surgical effectiveness and efficiency, we were a party to a license and distribution agreement with Blue Ortho SAS ("Blue Ortho") to bring computer based technology to the surgical techniques used with our products. Blue Ortho is a France-based computer-assisted surgical technology development and manufacturing firm. We launched the knee application of this technology under the trade name Exactech GPS® (Guided Personalized Surgery) during 2013, and intend to develop shoulder and hip applications in the future. We acquired Blue Ortho in January 2015.

Our Taiwanese subsidiary, Exactech Taiwan, entered into a license agreement with the Industrial Technology Research Institute (ITRI) and the National Taiwan University Hospital (NTUH) for the rights to technology and patents related to the repair of cartilage lesions. Using the technology, we plan to launch a cartilage repair program that would include a device and method for the treatment and repair of cartilage in the knee joint.  The agreement terms include a license fee based on the achievement of specific, regulatory milestones and a royalty arrangement based on sales if regulatory clearances are established. The technology is currently subject to clinical trial evaluation in Taiwan and we are currently evaluating regulatory approval pathways for this technology in other markets.

We believe that our purchase of intellectual property and product-line assets, augmented by additional development, provides a cost-effective and efficient way to bring products to market, and we expect to continue to do so in the future to complement our internal product development.

Competition

The orthopaedic device industry is highly competitive and dominated by a number of large companies with substantially greater financial and other resources.  Our largest competitors in the orthopaedic market are DePuy Synthes, Inc., a division of Johnson and Johnson, ZimmerBiomet, Inc., a subsidiary of Zimmer Biomet Holdings, Inc., Stryker Corporation, and Smith and Nephew plc.  According to “The Orthopaedic Industry Annual Report” for the year ended December 31, 2014, by Orthoworld, Inc., in 2014 these four companies had an estimated 58% of the total orthopaedic market share, including an estimated 83% of the global joint replacement segment.

Companies in the industry compete on the basis of product features and design, innovation, service, the ability to maintain new product flow, and the strength of their distribution network and price.  While price is a key factor in the orthopaedic market, there are other significant factors, including: surgeon preference, ease of use, clinical results, and service provided by us and our representatives.

Product Liability and Insurance

We are subject to potential product liability risks that are inherent in the design, manufacture and distribution of orthopaedic implants and surgical instrumentation.  We have implemented strict quality control measures and currently maintain product liability insurance in amounts that we believe are typical in the industry for similar companies.  For our most recent three fiscal years, we experienced stable insurance premiums as a percentage of sales.  We evaluate our levels of product liability insurance annually, as well as the amount of retention carried compared to other companies in the industry.  Due to the volatility of the insurance marketplace, the value of the product liability insurance products delivered and the small number of providers of these products, there can be no guarantees as to whether we will be able to secure such coverage in the future at a reasonable cost, or at all.

Government Regulation

Healthcare Regulation

Healthcare is heavily regulated by the federal government and by state and local governments.  The federal laws and regulations affecting healthcare change regularly thereby increasing the uncertainty and risk associated with any healthcare-related venture.  During 2010, Congress enacted the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (jointly, the Affordable Care Act), and the government is in the process of implementing that legislation. The Affordable Care Act significantly affects device manufacturers, most notably through the imposition of a 2.3% medical device excise tax on the first sale or use of products within the United States and the Physician Payment Sunshine Act, which requires medical device

8


 

manufacturers, among others, to annually report to the federal government any "payment or other transfer of value" to physicians and teaching hospitals. On December 18, 2015, the President signed into law the "Protecting Americans from Tax Hikes Act of 2015," which imposes a two-year moratorium on the medical device excise tax effective for sales made after December 31, 2015. The 2.3% excise tax on certain medical devices is scheduled to be reinstated for sales transacted after December 31, 2017.

The federal government regulates healthcare, in general, and Exactech, in particular, through various agencies, including but not limited to the following:  (i) the FDA, which administers the Food, Drug, and Cosmetic Act, or FD&C Act, as well as other relevant laws; (ii) the Centers for Medicare & Medicaid Services, or CMS, which administers the Medicare and Medicaid programs; (iii) the Office of Inspector General, or OIG, which enforces various laws aimed at curtailing fraudulent or abusive practices, including by way of example, the Anti-Kickback Statute, the physician self-referral prohibition, commonly referred to as the Stark law, the False Claims Act, the Anti-Inducement Law, the Civil Money Penalty Law, and the laws that authorize the OIG to exclude health care providers and others from participating in federal healthcare programs; and (iv) the Office of Civil Rights which administers the privacy aspects of the Health Insurance Portability and Accountability Act of 1996, or HIPAA.  All of the aforementioned are agencies within the Department of Health and Human Services, or HHS.  Healthcare is also provided to or regulated by, as the case may be, the Department of Defense through its TriCare program, the Department of Veterans Affairs under, among other laws, the Veterans Health Care Act of 1992, the Public Health Service within HHS under the Public Health Service Act, the Department of Justice through the Federal False Claims Act and various criminal statutes, and state governments under the Medicaid program and their internal laws regulating all healthcare activities.

 

I.

FDA Regulates the Design, Manufacture, and Distribution of Our Medical Devices

The FDA regulates medical devices and classifies medical devices into one of three classes.  Devices are subject to varying levels of regulatory control depending on their class.  In the United States, a company generally can obtain permission to distribute a new device in two ways.  The first applies to Class I and II devices that are substantially equivalent to a device first marketed prior to May 28, 1976 or to another device marketed after that date, but which was substantially equivalent to a pre-May 28, 1976 device.  To obtain FDA permission to distribute the device, a company generally must submit a pre-market notification application (a section 510(k) submission), and receive an FDA order finding substantial equivalence to a predicate device (pre-May 28, 1976 or post-May 27, 1976 device that was substantially equivalent to a pre-May 28, 1976 device) and permitting commercial distribution of that device for its intended use.  If clinical data from human clinical trials are required to support the 510(k) submission, these data must be gathered in compliance with investigational device exemption (IDE) regulations.  The FDA review process for pre-market notifications submitted pursuant to section 510(k) should take on average about 90 days, but recently it has taken longer and it can take substantially longer if the agency has concerns, and there is no guarantee that the agency will “clear” the device for marketing, in which case the device cannot be distributed in the United States.  Nor is there any guarantee that the agency will deem the article subject to the 510(k) process, as opposed to the more rigorous pre-market approval (“PMA”) process described below.

The PMA approval process applies to a new device that is not substantially equivalent to a pre-May 28, 1976 product, is an implantable device, or is to be used in supporting or sustaining life or preventing impairment.  These devices are normally Class III devices.  Two steps of FDA approval generally are required before a company can market a product in the U.S. that is subject to approval as opposed to clearance.  First, a company must comply with IDE regulations in connection with any human clinical investigation of the device.  Second, the FDA must review the company's pre-market approval (PMA) application, which contains, among other things, clinical information acquired under the IDE.  The FDA will approve the PMA application if it finds there is reasonable assurance the device is safe and effective for its intended use.  The PMA process takes substantially longer than the 510(k) process.

We currently market medical devices that have been cleared for marketing by the FDA under the 510(k) process and approved for marketing through the PMA process.  FDA approval or clearance, as the case may be, is always uncertain.  The agency may refuse to clear or approve a device or it may do so, but restrict its intended uses to such a degree that manufacturing and distributing the device is not commercially viable.

We are registered with the FDA as a device establishment.  As a result, we are subject to periodic inspection by the FDA for compliance with the FDA's Quality System Regulation requirements and other regulations.  The Medical Device Reporting regulations require that we provide information to the FDA whenever there is evidence to reasonably suggest that a device may have caused or contributed to a death or serious injury or, if a

9


 

malfunction were to occur, could cause or contribute to a death or serious injury.  In addition, the FDA prohibits us from promoting a medical device for unapproved or non-cleared indications.  The FDA, in the course of enforcing the FD&C Act, may subject a company to various sanctions for violating FDA regulations or provisions of the Act, including requiring recalls, issuing Warning Letters, seeking to impose civil money penalties, seizing devices that the agency believes are non-compliant, seeking to enjoin distribution of a specific type of device or other product, seeking to revoke an approval or clearance, seeking disgorgement of profits, and seeking to criminally prosecute a company and its officers and other responsible parties.

In many of the foreign countries in which we market our products, we are subject to local regulations affecting, among other things, design and product standards, packaging requirements and labeling requirements. Many of the regulations applicable to our devices and products in these countries are similar to those of the FDA. The member countries of the European Union have adopted the European Medical Device Directive, which creates a single set of medical device regulations for products marketed in all member countries. Compliance with the Medical Device Directive and certification to a quality system enable the manufacturer to place a CE mark on its products. To obtain authorization to affix the CE mark to a product, a recognized European Notified Body must assess a manufacturer's quality systems and the product's conformity to the requirements of the Medical Device Directive. We are subject to inspection by the Notified Bodies for compliance with these requirements. It should be noted that countries within the EU also retain jurisdiction to impose additional requirements on a device manufacturer.

There are also requirements of state, local and foreign governments that we must comply with in the manufacture and marketing of our products.

 

II.

Medicare and Medicaid Reimbursement Levels Are Uncertain and Subject to Change

Medicare reimburses for medical devices in a variety of ways depending on where and how the device is used.  Under Medicare prospective payment system, devices sold to hospitals and used in connection with treating an inpatient are not separately reimbursable by Medicare. Reduction in payments to hospitals under Medicare Part A (inpatient) or restrictions in coverage for those procedures using our devices would adversely affect us. Usually, Medicaid pays less than Medicare, assuming that the state covers the service.  In addition, private payers, including managed care payers, increasingly are demanding discounted fee structures and the assumption by healthcare providers of all or a portion of the financial risk.  Efforts to impose greater discounts and more stringent cost controls upon healthcare providers, e.g., physicians, by private and public payers are expected to continue.

Significant limits on the scope of services covered or on reimbursement rates and fees on those services that are covered could have a material adverse effect on our ability to commercialize our products and therefore, on our liquidity and financial condition.

On November 24, 2015, CMS published its Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services, or CJR Rule, which dramatically affects the way in which Medicare pays hospitals for joint replacement surgery, which is the type of surgery that uses many of our devices, such as hips and knees.  Under this Rule, hospitals will receive a single bundled payment to cover both inpatient surgical and outpatient post-surgical services, such as rehabilitation.  The CJR Rule is supposed to test whether bundled payments to acute care hospitals for lower extremity joint replacement episodes of care will reduce Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries.  Although device manufacturers are not directly included in the CJR Rule, as are rehabilitation facilities and skilled nursing homes, it is likely that this Rule will have an economic impact on those that manufacture hips, knees and devices related to their surgical implantation.  We are in the process of evaluating the impact of the CJR Rule on our business.

 

III.

We Must Comply with Anticorruption, Anti-Fraud and Abuse Rules Which Are Vigorously Enforced Throughout the World

There are extensive federal and state laws and regulations prohibiting fraud and abuse in the healthcare industry, the violation of which can result in significant criminal and civil penalties, including exclusion from participation in federal reimbursement programs that can materially affect us.  These federal laws include, by way of example, the following:

·

The Anti-Kickback Statute (Section 1128B(b) of the Social Security Act) prohibits certain business practices and relationships that might affect the provision and cost of healthcare services reimbursable under

10


 

Medicare, Medicaid and other federal healthcare programs, including the payment or receipt of remuneration for the referral of patients whose care will be paid in whole or in part by Medicare or other governmental programs;  

·

Most countries in which we operate have some form of an anti-corruption law, including the Foreign Corrupt Practices Act in the United States and the UK Bribery Act in the United Kingdom.  These laws generally prohibit payments to foreign government officials or others to assist in obtaining or retaining business;

·

The physician self-referral prohibition (Ethics in Patient Referrals Act of 1989, as amended, commonly referred to as the Stark Law, Section 1877 of the Social Security Act), which prohibits referrals by physicians of Medicare or Medicaid patients to providers of a broad range of designated healthcare services in which the physicians (or their immediate family members) have ownership interests or with which they have certain other financial arrangements;  

·

The anti-inducement law (Section 1128A(a)(5) of the Social Security Act), which prohibits providers from offering anything to a Medicare or Medicaid beneficiary to induce that beneficiary to use items or services covered by either program;

·

The False Claims Act (31 U.S.C. § 3729 et seq.), which prohibits any person from knowingly presenting or causing to be presented false or fraudulent claims for payment to the federal government or federal contractor or grantee (including the Medicare and Medicaid programs); and

·

The Civil Monetary Penalties Law (Section 1128A of the Social Security Act), which authorizes the United States Department of Health and Human Services to impose civil penalties administratively for fraudulent or abusive acts.

Sanctions for violating these federal laws include criminal and civil penalties that range from punitive sanctions, damage assessments, money penalties, imprisonment, to denial of Medicare and Medicaid payments, or exclusion from the Medicare and Medicaid programs or both.

Many states have adopted or are considering legislative proposals similar to the federal fraud and abuse laws, some of which extend beyond the Medicare and Medicaid programs to prohibit the payment or receipt of remuneration for the referral of patients and physician self-referrals regardless of whether the service was reimbursed by Medicare or Medicaid.  Many states have also adopted or are considering legislative proposals to increase patient protections, such as limiting the use and disclosure of patient specific health information.  These state laws also impose criminal and civil penalties similar to the federal laws.

In the ordinary course of their business, medical device manufacturers and suppliers have been and are subject regularly to inquiries, investigations and audits by federal and state agencies that oversee these laws and regulations.  Recent federal and state legislation has greatly increased funding for investigations and enforcement actions which have increased dramatically over the past several years.  This trend is expected to continue. See Item 1A. Risk Factors for discussion on our compliance activities related to the Corporate Integrity Agreement with the OIG.  Private enforcement of healthcare fraud also has increased due in large part to amendments to the civil False Claims Act in 1986 that were designed to encourage private persons to sue on behalf of the government.

As federal and state budget pressures continue, federal and state administrative agencies may also continue to escalate investigation and enforcement efforts to control fraud and abuse in governmental healthcare programs.  A violation of any of these federal and state fraud and abuse laws and regulations could have a material adverse effect on a suppliers' liquidity and financial condition.  An investigation into the use of a device by physicians may dissuade physicians from either purchasing or using the device.  This could have a material adverse effect on our ability to commercialize the device.

 

IV.

We May be Compelled to Comply with the Privacy Provisions of HIPAA

HIPAA, among other things, protects the privacy and security of individually identifiable health information by limiting its use and disclosure.  HIPAA directly regulates “covered entities” (healthcare providers, insurers, and clearinghouses) and indirectly regulates “business associates” with respect to the privacy of patients' medical information.  All entities that receive and process protected health information are required to adopt certain procedures to safeguard the security of that information.  It is uncertain whether we would be deemed to be a

11


 

covered entity under HIPAA, and, based on our current business model, it is unlikely that we would be a business associate.  However, HIPAA was amended on February 17, 2009, as part of the American Recovery and Reinvestment Act of 2009, to broaden the requirements imposed on covered entities and business associates, to authorize the imposition of civil money penalties and other penalties on those who violate HIPAA, and to authorize States to institute suit to protect the privacy under HIPAA of their citizens. Irrespective of whether we are deemed to be a covered entity or a business associate, we will likely be contractually required to physically safeguard the integrity and security of any patient information that we receive, store, create or transmit. Moreover, many states have privacy statutes that might apply to our operations, even if HIPAA does not.

Environmental Law Compliance

Our operations are subject to numerous and increasingly stringent federal, state and local environmental laws and regulations in the United States and other countries in which we operate concerning, among other things, the generation, handling, storage, transportation, treatment and disposal of toxic and hazardous substances and the discharge of pollutants into the environment.  Environmental permits and controls are required for some of our manufacturing operations, and these permits are subject to modification, renewal and revocation by the issuing authorities.  We do not have underground storage tanks, and we believe that our facilities are in material compliance with our permits and environmental laws and regulations. We do not believe that future environmental compliance will have a material adverse effect on our business, financial condition or results of operations.  Our environmental capital expenditures and costs for environmental compliance may increase in the future as a result of changes in environmental laws and regulations or as a result of increased manufacturing activities at our facilities.  We could be materially adversely affected by any failure to comply with environmental laws, including the costs of undertaking a clean-up at a site to which our wastes were transported.

Employees

As of December 31, 2015, we employed 674 full-time employees.  We have no union contracts and believe that our relationship with our employees is good.

Executive Officers of the Registrant

Our executive officers, and their ages are as follows:

 

Name

Age

 

Position

William Petty, M.D.

 

73

 

Executive Chairman and Chairman of the Board

David W. Petty

 

49

 

Chief Executive Officer, President and Director

Gary J. Miller, Ph.D.

 

68

 

Executive Vice President, Research and Development

Joel C. Phillips

 

48

 

Executive Vice President, Chief Financial Officer and Treasurer

Bruce Thompson

 

58

 

Senior Vice President, General Manager - Biologics and Spine Division

Betty Petty

 

73

 

Vice President, Administration and Corporate Secretary

Donna Edwards

 

43

 

Vice President, Legal

 

William Petty, M.D. is a founder of Exactech.  He has been Executive Chairman since March 2014, Chairman of the Board of the Company since its inception, was Chief Executive Officer from inception until 2014 and was President from January 2002 until December 2007.  Dr. Petty was a Professor at the University of Florida College of Medicine from July 1975 to September 1998.  Dr. Petty also served as Chairman of the Department of Orthopaedic Surgery at the University of Florida College of Medicine from July 1981 to January 1996. Dr. Petty has served as a member of the Hospital Board of Shands Hospital, Gainesville, Florida, as an examiner for the American Board of Orthopaedic Surgery, as a member of the Orthopaedic Residency Review Committee of the American Medical Association, on the Editorial Board of the Journal of Bone and Joint Surgery, on the Executive Board of the American Academy of Orthopaedic Surgeons, and as President of the Corporate Advisory Council of the American Academy of Orthopaedic Surgeons.  He holds the Kappa Delta Award for Outstanding Research from the American Academy of Orthopaedic Surgeons.  His book, Total Joint Replacement, was published in 1991.  Dr. Petty received his B.S., M.S., and M.D. degrees from the University of Arkansas.  He completed his residency in Orthopaedic Surgery at the Mayo Clinic in Rochester, Minnesota.  Dr. Petty is the husband of Betty Petty, and the father of David W. Petty.

David W. Petty has been Chief Executive Officer since March 2014 and President of Exactech since November 2007.  Mr. Petty has served the Company in various capacities in the areas of operations and sales and

12


 

marketing since joining the Company in 1988.  From February 2000 to November 2007, Mr. Petty served as Executive Vice President of Sales and Marketing, from 1993 to 2000, he served as Vice President of Marketing and, from April 1991 until April 1993, he served as Vice President of Operations.  Mr. Petty received his B.A. from the University of Virginia in 1988 and completed The Executive Program of the Darden School of Business in 1999.  He is the son of Dr. and Ms. Petty.

Gary J. Miller, Ph.D. is a founder and has been Executive Vice President, Research and Development of Exactech since February 2000.  He was Vice President, Research and Development from 1986 until 2000 and was a Director from March 1989 through May 2003.  Dr. Miller was Associate Professor of Orthopaedic Surgery and Director of Research and Biomechanics at the University of Florida College of Medicine from July 1986 until August 1996.  Dr. Miller received his B.S.M.E. from the University of Florida, his M.S.M.E. (Biomechanics) from the Massachusetts Institute of Technology, and his Ph.D. in Mechanical Engineering (Biomechanics) from the University of Florida.  He has held appointments as an Adjunct Associate Professorship in the College of Veterinary Medicine's Small Animal Surgical Sciences Division and as an Adjunct Associate Professor in the Department of Aerospace, Mechanics and Engineering Sciences. He currently holds a Courtesy Professorship in the Department of Mechanical and Aerospace Engineering, University of Florida. He was a consultant to the FDA from 1989 to 1992 and has served as a consultant to such companies as Johnson & Johnson Orthopaedics, Dow-Corning Wright and Orthogenesis.

Joel C. Phillips, CPA has been Chief Financial Officer of Exactech since July 1998 and Treasurer since March 1996. Mr. Phillips was promoted to Executive Vice President in February 2015.  Mr. Phillips was Manager, Accounting and Management Information Systems at the Company from April 1993 to June 1998.  From January 1991 to April 1993, Mr. Phillips was employed by Arthur Andersen.  Mr. Phillips received a B.S. and a Masters in Accounting from the University of Florida and is a Certified Public Accountant. During 2008, Mr. Phillips completed the Advanced Executive Program at the Kellogg School of Management at Northwestern University.

Bruce Thompson has been Senior Vice President, General Manager - Biologics Division since joining the Company in July 2004. In 2008 he assumed the role of general manager of both the biologics and spine divisions of Exactech. Prior to joining Exactech, Mr. Thompson spent 22 years with Smith & Nephew in their Orthopaedic Division.  During that time, he held various positions within Smith & Nephew, including Vice President - International Sales, Vice President - Product Planning and Launch, Vice President, General Manager - Spine Division, Group Director of Trauma Manufacturing, Director of Materials Management, and held various product and sales management positions.  Mr. Thompson earned a B.S. in Accountancy at Miami University, Oxford, Ohio, and completed the Executive MBA program at the University of Memphis in 1989.

Betty Petty is a founder, Corporate Secretary, and Vice President, Administration. She has been Vice President, Administration since February 2000.  She was Vice President, Human Resources from February 2000 until May 2010. She has also been Corporate Secretary of Exactech since its inception and served as Treasurer and a Director until March 1996.  Ms. Petty served in the dual capacities of Human Resources Coordinator and Director of Marketing Communications from the founding of the Company until 2001.  She received her B.A. from the University of Arkansas at Little Rock and her M.A. in English from Vanderbilt University.  Ms. Petty is the wife of Dr. Petty and the mother of David W. Petty.

Donna Edwards has been our Vice President of Legal since August 2011. She has currently been employed by Exactech since January 2001, in the capacity of Interim Compliance Officer from April 2011 to August 2011, Corporate Attorney from February 2003 to April 2011, and Legal Coordinator from January 2001 to February 2003. Previously, she was employed by Exactech as Regulatory Affairs Coordinator from June 1996 to August 1998. Ms. Edwards received her B.S. degree from Duke University and her J.D. degree from the University of Alabama.

Our officers are elected annually by the Board of Directors and serve at the discretion of the Board.

Available Information

Our Internet website address is www.exac.com.  We make available free of charge on or through our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and any other reports we file or furnish under the Securities Exchange Act of 1934, as amended, as well as Section 16 insider holdings reports on Form 3, Form 4 and Form 5, filed by our executive officers and directors and all amendments to these reports, as soon as reasonably practicable after such material is filed electronically with, or furnished to, the Securities and Exchange Commission (SEC). These reports may be found at

13


 

http://www.exac.com/investors/financials by selecting the option entitled “SEC FILINGS”.  Additionally, our board committee charters and code of ethics are available on our website and in print to any shareholder who requests them. We intend to post to this website all amendments to the charters and code of ethics. We do not intend for information contained in our web site to be part of this Annual Report on Form 10-K.  In addition, the SEC maintains an Internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at http://www.sec.gov.

 

 

ITEM 1A.

RISK FACTORS

You should carefully consider the risks described below, together with all of the other information in this Annual Report on Form 10-K.  If any of the following risks actually occurs, our business, financial condition and results of operations could suffer and the trading price of our common stock could decline.

The Corporate Integrity Agreement that we entered into in December 2010 expired in December 2015; however we have yet to receive final approval from the OIG with respect to our compliance with its terms.

In December 2010, we entered into a Corporate Integrity Agreement, referred to as the CIA, with the Office of Inspector General of the United States Department of Health and Human Services (OIG-HHS). The foregoing agreement resolved the investigation commenced by the Department of Justice in December 2007 into the Company's consulting arrangements with orthopaedic surgeons relating to our hip and knee products in the United States. The CIA imposed on us certain obligations to maintain compliance with U.S. healthcare regulatory laws. Our failure to have demonstrated compliance with its terms could expose us to significant liability including, but not limited to, exclusion from federal healthcare program participation, including Medicaid and Medicare, civil and criminal fines or penalties, and additional litigation cost and expense. Any of these consequences would have a material adverse effect on our financial position, results of operations and cash flows. The CIA acknowledges the existence of our Corporate Compliance Program and provides for certain other compliance-related activities during the five-year term of the agreement. If we are found to have breached the CIA, the OIG-HHS could take further action against us, up to and including excluding us from participation in federal healthcare programs, which would have a material adverse effect on our financial condition, results of operations and cash flows. The five-year term of the CIA expired in December 2015, and we are awaiting the OIG’s approval of our compliance with its terms.

Our settlement with the United States Department of Justice and OIG-HHS could lead to further governmental investigations or actions by other third parties.

As a result of the allegations of wrongdoing and the public disclosure of our settlement with the OIG-HHS, other governmental agencies, including state authorities, could conduct their own investigations or institute proceedings, none of which is precluded by terms of our existing settlement. The costs of defending or resolving any such investigations or proceedings could have a material adverse effect on our financial condition, results of operations and cash flows.

Efforts to enhance our corporate compliance program require the cooperation of many individuals, may divert resources from our other business activities and may require substantial investment.

We are committed to the continued enhancement of our corporate compliance program, which requires substantial financial and human resources. The continued successful implementation of our enhanced corporate compliance program requires significant cooperation from our employees, distributors and sales agents as well as the healthcare professionals with whom our agents interact. The increased expenses related to these efforts may negatively impact our results of operations.

Economic downturns, both domestically and internationally, and disruptions in capital and credit markets may adversely affect the availability and cost of funds necessary for us to meet both our short term and long-term funding needs and may otherwise impair our ability to grow our business, any of which could adversely affect our results of operations, cash flows and financial condition.

Our business may be negatively affected by economic downturns, which could negatively affect the availability of credit. We rely predominantly on the credit markets and borrowing under our existing credit facility to meet our financial commitments and short-term liquidity needs to the extent that funds are not available from our operations. Disruptions in the capital and credit markets could adversely affect our ability to draw on our credit facility and could make alternative funding, such as our raising of capital through the public or private issuance of equity or debt securities, unavailable on reasonable terms or at all. Our access to funds under our current credit facility is dependent on the ability of the lending banks thereunder to meet their respective funding commitments.

14


 

If our lenders are unable to obtain funds, whether due to a shortage of liquidity in the banking system or otherwise, then they may not be able to meet their respective funding commitments to us, which would adversely affect our liquidity and cash flows.

Long-term disruptions in the capital and credit markets could adversely affect our liquidity and require that we conserve cash until the markets stabilize or until alternative credit or funding arrangements can be obtained. Our conservation of cash in such instances could require that we defer capital expenditures and reduce or eliminate discretionary uses of cash, which could harm our competitive position and results of operation.

Our industry is experiencing greater scrutiny and regulation by governmental authorities, which may lead to greater regulation in the future.

The premarket review, manufacture, marketing, sale and third-party coverage of and payment for our medical devices are subject to significant regulation by various federal agencies and departments, including the United States Department of Justice, the United States Department of  Defense, the United States Department of Veterans Affairs, and various agencies within the United States Department of Health and Human Services, including FDA, OIG-HHS, Centers for Medicare & Medicaid Services (CMS), Office of Civil Rights, and numerous other federal, state, and foreign governmental authorities. These authorities have been increasing their scrutiny of our industry. In addition, certain state governments and the federal government have enacted legislation aimed at increasing transparency of our interactions with health care providers. The Affordable Care Act included a provision titled the Physician Payment Sunshine Act.  CMS has been charged with implementing the Sunshine Act and has called it the Open Payment Program.  As a result, we are required by law to annually disclose payments and other transfers of value to health care providers licensed by certain states and, starting with payments or other transfers of value made on or after August 1, 2013, to all U.S. physicians and U.S. teaching hospitals. Any failure to comply with these legal and regulatory requirements could have adverse legal consequences. In addition, we may continue to devote substantial additional time and financial resources to further develop and implement policies, systems, and processes to comply with enhanced legal and regulatory requirements, which may also affect our business.  We anticipate that government and congressional scrutiny of our sector will continue and potentially increase and that additional regulation may increase compliance and legal costs, exposure to litigation, and other adverse effects to our operations.

Our products are subject to many laws and governmental regulations and any adverse regulatory action may materially adversely affect our financial condition and business operations.

Our medical devices are subject to regulation by numerous government agencies, including the FDA and comparable agencies outside the U.S.  To varying degrees, each of these agencies requires us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing, and distribution of our medical devices. We cannot guarantee that we will be able to obtain marketing clearance or approval for our new products or enhancements or modifications to existing products. If such clearance or approval is obtained, as the case may be, it may: (1) take significant time; (2) require the expenditure of significant resources; (3) involve costly and extensive clinical and pre-clinical testing, as well as increased post-market surveillance; (4) involve modifications, repairs, or replacements of our products, and (5) result in limitations on the proposed uses of our products.  The approved or cleared uses of our products limits how are products can be marketed and may limit third-party coverage of procedures involving our products depending on whether the approved or cleared uses of our products are consistent with the coverage criteria of the third-party payor.

Both before and after a product is commercially released, we have ongoing responsibilities under the Food, Drug, and Cosmetic Act and its implementing regulations. We are also subject to periodic inspections by the FDA to determine compliance with the FDA’s requirements, including, among other things, the quality system regulations and medical device reporting regulations. The results of these inspections can include inspectional observations on Form FDA-483, untitled letters, warning letters, or other forms of enforcement.  Since 2009, the FDA has significantly increased its oversight by hiring new investigators and increasing inspections of manufacturing facilities. The FDA has recently also significantly increased the number of warning letters issued to companies. If the FDA were to conclude that we are not in compliance with applicable laws or regulations, or that any of our medical devices are ineffective or pose an unreasonable health risk, the FDA could ban such medical devices, detain or seize adulterated or misbranded medical devices, order a recall, repair, replacement, or refund of such devices, refuse to grant pending pre-market approval applications or require certificates of foreign governments for exports, or  require us to notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health. The FDA may also impose operating restrictions on a company-wide basis, enjoin or restrain certain conduct that gave rise to regulatory violations pertaining to medical devices, and assess civil or criminal penalties against our officers, employees, or us. The FDA may also recommend criminal

15


 

prosecution to the DOJ. Any adverse regulatory action, depending on its magnitude, may adversely affect our ability to sell our products.

In addition, device manufacturers are permitted to promote products solely for the uses and indications set forth in the approved product labeling. A number of enforcement actions have been taken against manufacturers that promote products for “off-label” uses, including actions alleging that federal health care program claims for reimbursement of products promoted for “off-label” uses are false and fraudulent claims to the government. The failure to comply with “off-label” promotion restrictions can result in significant administrative obligations and costs, and potential penalties from, and/or agreements with, the federal government.

Our failure to comply with rules relating to reimbursement and regulation of health care goods and services may subject us to penalties and adversely impact our reputation and business operations.

Our devices are subject to regulation regarding coverage and cost by non-FDA agencies within HHS, including the CMS as well as comparable state and non-U.S. agencies responsible for reimbursement and regulation of health care goods and services, as well as by private insurers and other third-party payors. Federal government health care laws apply when we submit a claim on behalf of a federal health care program beneficiary, or when a customer submits a claim for an item or service that is reimbursed, in whole or in part, under a federal government-funded health care program, such as Medicare or Medicaid. The principal federal laws implicated include those that prohibit the filing of false or improper claims for federal payment, the primary one of which is the False Claims Act; those that prohibit unlawful inducements for the referral of business reimbursable under federally-funded health care programs, known as the Anti-Kickback Statute and Anti-Inducement Act; and that which prohibits health care service providers seeking reimbursement for providing certain services to a patient who was referred by a physician who has certain types of direct or indirect financial relationships with the service provider, known as the Stark law.

If a governmental authority were to conclude that we are not in compliance with applicable laws and regulations, we and our officers and employees could be subject to severe criminal and civil penalties, including, for example, exclusion from participation as a supplier of product to beneficiaries covered by CMS. If we are excluded from participation based on such an interpretation it could adversely affect our reputation and business operations.

Failure to comply with certain federal laws is particularly acute for us given the CIA under which we agree to independent monitoring of our activities and reporting of those activities that fail to comply with federal law or the CIA.

We may be subject to suit under a federal whistleblower statute.

Those who engage in business with the federal government, directly or indirectly, may be sued under a federal whistleblower statute designed to combat fraud and abuse in the healthcare industry. These lawsuits, known as qui tam suits, are authorized under certain circumstances by the False Claims Act and can involve significant monetary damages and award bounties to private plaintiffs who successfully bring these suits. If any of these lawsuits were to be brought against us, such suits combined with increased operating costs and substantial uninsured liabilities could have a material adverse effect on our financial condition and operations.

The Affordable Care Act has sought to link violations of the Anti-Kickback Statute with violations of the False Claims Act, making it arguably easier for the government or for whistleblowers, acting in the name of the government, to sue device manufacturers under the False Claims Act.  Another law, enacted in 2009, attempts to ease some of the other requirements that restricted whistleblower and other False Claims Act suits.  Some of these requirements may be retroactive to 2008, but the constitutionality of that provision has yet to be resolved by the U.S. Supreme Court.

Quality problems with our processes, goods, and services could harm our reputation for producing high-quality products and erode our competitive advantage, sales, and market share.

Quality is extremely important to us and our customers due to the serious and costly consequences of product failure. Our quality certifications are critical to the marketing success of our goods and services. If we fail to meet these standards, our reputation could be damaged, we could lose customers, and our revenue and results of operations could decline. Aside from specific customer standards, our success depends generally on our ability to manufacture to exact tolerances precision-engineered components, subassemblies, and finished devices from multiple materials. If our components fail to meet these standards or fail to adapt to evolving standards, our reputation as a manufacturer of high-quality components will be harmed, our competitive advantage could be

16


 

damaged, and we could lose customers and market share.  Moreover, failure to comply with our internal standards may result in the FDA viewing our products as misbranded or adulterated and subject to voluntary or involuntary recall or seizure or other sanctions including criminal and civil penalties.

Healthcare policy changes, including U.S. healthcare reform legislation signed in 2010, may have a material adverse effect on us.

In response to perceived increases in health care costs in recent years, there have been and continue to be proposals by the federal government, state governments, regulators, and third-party payers to control these costs and, more generally, to reform the U.S. health care system. Certain of these proposals could limit the prices we are able to charge for our products or the amounts of reimbursement available for our products and could limit the acceptance and availability of our products. The adoption of some or all of these proposals could have a material adverse effect on our financial position and results of operations.

In March 2010, the President signed into law the Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act of 2010. Certain provisions of these acts were implemented in 2014 and other provisions will be implemented later, therefore, it is difficult to assess the full long-term impact of these laws on our business.  Certain adverse effects though are apparent.  The legislation imposes significant new taxes on medical device makers in the form of a 2.3% excise tax on all U.S. medical device sales that commenced in January 2013. Under the legislation, the total cost to the medical device industry is expected to be approximately $20 billion over 10 years. We currently estimate that our annual excise tax fee will be within the range of $1.9 to $2.2 million pre-tax. On December 18, 2015, the President signed into law the "Protecting Americans from Tax Hikes Act of 2015," which imposes a two-year moratorium on the medical device excise tax effective for sales made after December 31, 2015; however, the 2.3% excise tax on certain medical devices is scheduled to be reinstated for sales transacted after December 31, 2017. The Affordable Care Act also focuses on a number of Medicare provisions aimed at improving quality and decreasing costs. It is uncertain at this point what negative unintended consequences these provisions will have on patient access to new technologies. The Medicare provisions include value-based payment programs, increased funding of comparative effectiveness research, reduced hospital payments for avoidable readmissions and hospital acquired conditions, and pilot programs to evaluate alternative payment methodologies that promote care coordination (such as bundled physician and hospital payments). Additionally, the law includes a reduction in the annual rate of inflation for Medicare payments to hospitals that began in 2011 and the establishment of an independent payment advisory board to recommend ways of reducing the rate of growth in Medicare spending beginning in 2014. We cannot predict what health care programs and regulations will be ultimately implemented at the federal or state level, or the effect of any future legislation or regulation. However, any changes that lower reimbursement for our products or reduce medical procedure volumes could adversely affect our business and results of operations.

Since the enactment of the Affordable Care Act, the President has signed into law various bills affecting or potentially affecting reimbursement for health care including by way of example, the Medicare and Medicaid Extenders Act of 2010, Budget Control Act of 2011, the American Taxpayer Relief Act of 2012, and Medicare Access and CHIP Reauthorization Act of 2015.  The Budget Control Act imposed a 2% reduction on payments to hospitals under Part A, which has a negative effect on those selling products to hospitals, including device manufacturers.  We have not yet fully assessed the long-term effects of the various post-Affordable Care Act laws.

We expect the healthcare industry to face increased scrutiny over reimbursement and healthcare reform, which could adversely impact how much or under what circumstances healthcare providers will prescribe or administer our products.

In the United States and other countries, sales of our products depend, in part, upon the availability of reimbursement from third party payers, which include government health administration authorities, managed care providers and private health insurers. Third party payers are increasingly challenging the price and examining the cost effectiveness of medical products and services. Increasing expenditures for healthcare have been the subject of considerable public attention in the United States and abroad. Both private and government entities are seeking ways to reduce or contain healthcare costs. Numerous proposals that would effect changes in the U.S. healthcare system have been introduced or proposed in Congress and in some state legislatures. Although we cannot predict the full effect on our business of the implementation of this legislation, we believe that legislation that reduces reimbursement for our products or for procedures that use our products would adversely affect sales. This could materially and adversely affect our business by reducing our ability to generate revenue, raise capital, obtain additional collaborators and market our products.

17


 

We must incur significant expenditures in order to maintain relatively high levels of inventory, which can reduce our cash flows.

Because we must maintain substantial levels of inventory, we are subject to the risk of inventory obsolescence. If a substantial portion of our inventory became obsolete, then we would experience a material adverse effect on our earnings and cash flows due to the resulting inventory impairment charges and out-of-pocket costs required to replace such inventory.

We rely upon third party suppliers for raw materials and supplies, and such parties' failure to perform would result in increased production costs.

Some of our suppliers rely on a single source of supply for raw materials and/or other inputs of production. Should the availability and on-time delivery of raw materials and supplies needed in the production of our products and services become unreliable or significantly more costly, then our earnings may be materially and adversely impacted due to the resulting increased costs of production.

We conduct business in a highly competitive industry.

The orthopaedic implant industry is subject to competition in the following key areas: product features and design, innovation, service, the ability to maintain new product flow, clinical acceptance of our products by key orthopaedic surgeons and hospitals, strength of distribution network and price. In addition, we compete to obtain and retain regional sales representatives within the medical community. Our largest competitors in the orthopaedic device market are DePuy Synthes, Inc., a division of Johnson and Johnson, ZimmerBiomet, Inc., a subsidiary of Zimmer Biomet Holdings, Inc., Stryker Corporation, and Smith and Nephew plc. Many of our competitors have significantly greater resources than us, and we cannot provide assurance that we will be able to compete successfully, which could have a material adverse effect on our revenues, cash flows and results of operations.

Our success is partially dependent upon our ability to successfully market new and improved products and the failure of the market to accept our new or improved products, or our failure to successfully market these products would adversely impact our revenues, cash flows and results of operations.

The failure of our products to gain market acceptance would likely have a material adverse effect on our revenues, cash flows and results of operations. We cannot provide assurance that our products will gain market acceptance. Future acceptance and use of our products will depend upon a number of factors including, among others:

 

·

perceptions by surgeons, patients, third party payers and others in the medical community, about the safety and effectiveness of our products;

 

·

the willingness of the target patient population to try new products and of surgeons to decide to use these products;

 

·

the prevalence and severity of any side effects, including any limitations or warnings contained in our product's approved labeling;

 

·

the efficacy and potential advantages relative to competing products and products under development;

 

·

effectiveness of education, marketing and distribution efforts by us and our licensees and distributors, if any;

 

·

publicity concerning our products or competing products and treatments;

 

·

reimbursement of our products by third party payers; and

 

·

the price for our products and competing products.

We distribute and sell certain third party manufacturers' products, and these third parties could discontinue their relationships with us.

Should we fail to meet the minimum sales performance or purchase commitments contained in our distribution agreements with third party manufacturers, those third parties may elect to discontinue our distribution of their

18


 

respective products and services. Should we lose the rights to one or more of our distribution agreements, it could have a material adverse effect on our revenues, cash flows, and results of operations.

We cannot provide assurance as to the level of protection that patents on specific designs and processes will afford us, and, with respect to some products, we rely on trade secrets and proprietary know-how which provide less protection.

We cannot provide assurance as to the breadth or degree of protection that existing or future patents, if any, may afford us, that confidential or proprietary information agreements will not be breached, that the parties from whom we have licensed or otherwise acquired patent rights, proprietary rights and technology have full rights to those patent rights and technology, or that our trade secrets and proprietary know-how will not otherwise become known to or independently developed by competitors. Our Optetrak knee system and Equinoxe shoulder system are subject to patents that we license or hold. Due to the relatively large percentage of our revenues attributable to the Optetrak knee and Equinoxe shoulder systems, if it were determined that the holders of these patents do not have sufficient legal rights to the patents, our use of the patents could be compromised, which would have a material adverse effect on our revenues, cash flows, and results of operations.

Our business depends on proprietary technology that we may not be able to protect and which may infringe on the intellectual property rights of others.

Our success depends, in part, on the strength of the intellectual property rights relating to our products and proprietary technology. We cannot assure you that we can obtain patent protection for all of our products, whether in the United States or abroad, or that any protection that is obtained would be effective or would withstand challenges as to validity and enforceability.

We do not currently have patent protection for all of our products. For our unpatented products, the only intellectual property rights that exist at present, if any, are trade secret rights. We cannot assure you that others will not readily ascertain by proper means the unpatented technology used in or embodied by our products, or that others will not independently develop substantially equivalent products or that we can meaningfully protect the rights to unpatented products. We cannot guarantee that our agreements with our employees, consultants, advisors, sub-licensees and strategic partners restricting the disclosure and use of trade secrets, inventions and confidential information relating to our products will provide meaningful protection.

It is possible that third parties may assert that our products infringe upon their proprietary rights, and it is virtually impossible for us to be certain that no infringement exists. Furthermore, because we have acquired some of the intellectual property used in our business from third parties, there are inherent uncertainties about the origin and ownership of this intellectual property that could contribute to our infringement exposure.

It is also possible that we may need to acquire additional licenses from third parties in order to avoid infringement. We cannot assure you that any required license would be made available to us on acceptable terms, if at all.

We could incur substantial costs in defending ourselves in suits brought against us for alleged infringement of another party's intellectual property rights as well as in enforcing our rights against others; and if we were found to infringe on the intellectual property rights of others, the manufacture, sale and use of our products could be enjoined. Any claims against us, whether such claims were with or without merit, would likely consume a significant amount of management's time and resources. Furthermore, parties who may bring claims against us could have greater resources than we have.

Any of these events could materially harm our cash flow, liquidity, and results of operations.

International patent protection is particularly uncertain, and if we are involved in opposition proceedings in foreign countries, we may have to expend substantial sums and management resources.

Patent law outside the United States is in some cases different than in the United States and is currently undergoing review and revision in many countries. Further, the laws of some foreign countries may not protect our intellectual property rights to the same extent as the laws of the United States. For example, certain countries do not grant patent claims that are directed to the treatment of humans. We may participate in opposition proceedings to determine the validity of our foreign patents or our competitors’ foreign patents, which could result in substantial costs and diversion of our efforts.

19


 

We must devote substantial resources to research and development, which adversely impacts our cash flows and provides no guarantee of success.

We devote substantial resources to research and development, but cannot provide assurance that we will be successful in developing successful new products or improving existing products so that our products remain competitive and avoid obsolescence. In addition, whether or not successful, research and development costs are significant, and our research and development efforts place stress on our cash flows, which could have a material adverse effect on our business if we are unsuccessful in developing and producing competitive products that achieve market acceptance.

We are subject to potential product liability risks, which are inherent in the design, marketing and sale of orthopaedic implants and surgical instrumentation.

We cannot provide assurance we will not face product liability claims that result in substantial liability for which we are not fully insured. A large, successful claim against us, for which we are partially or completely uninsured, could have a material adverse effect on our earnings and cash flows due the cost of defending against such a claim, together with the cost associated with any payment of damages. Even if a product liability claim is meritless, otherwise unsuccessful or not in excess of our insurance coverage limits, our cash available for other purposes, such as research and development, could be adversely affected, causing  a material adverse effect on our business and results of operations. Additionally, product liability claims may result in reduced demand for our products, which would have a material adverse effect on our business and results of operations, and could also result in a decline in the market price of our common stock.

We may not be able to secure and maintain adequate levels of product liability insurance coverage on acceptable terms, or at all.

Product liability insurance premiums are volatile. If premiums increase significantly, then our operating costs would increase, which could have a material adverse effect on our earnings and cash flows. We presently carry product liability insurance with coverage in an amount we consider reasonable and customary. However, this insurance coverage includes various deductibles, limitations and exclusions from coverage and may not fully cover all potential claims. We may not be able to obtain adequate insurance in the future at an acceptable cost, or at all, which could result in our need to self-insure and otherwise have an adverse effect on our liquidity and results of operations.

Both our products and third party products that we distribute may be subject to recalls or product liability claims.

Both our products and third-party products that we distribute are used in medical procedures; therefore all products sold by us must function with precision and accuracy. If any of these products do not function as designed, or are designed improperly, we or the third party manufacturer of these products may have to withdraw such products from the market whether by choice or due to a regulatory order. In addition, if patients suffer injury as a result of any failure of these products to function as designed, or as a result of a defective design, we could be subject to lawsuits seeking significant compensatory and punitive damages. Any product recall or lawsuit seeking significant monetary damages may have a material adverse effect on our business, operations or financial condition.

We partially depend on third parties for sales and marketing, and our inability to effectively utilize the services provided by these third parties would materially adversely impact our ability to generate sales.

We depend on independent sales representatives and distributors for the sale and marketing of certain of our products in international markets. Our contracts with distributors generally grant them the exclusive right to market our products in a specified territory and contain particular sales quotas. Our arrangements with our independent sales representatives and distributors typically do not preclude them from selling competitive products. Our success depends in part upon the expertise of our independent sales representatives and distributors and the acceptance of our products by our customers. Our inability to attract and retain qualified sales representatives and distributors would have a material adverse effect on our business, results of operations, financial condition and prospects.

As our international operations have grown, we have transitioned certain of our international sales operations from independent distributors to direct sales operations.  During the period of this transition our expenses have increased, and our revenues and related operating profits have been negatively impacted.  As the foregoing transition continues, our results of operations could be adversely impacted.  If we are unable to effectively

20


 

manage significant distributor transitions, then we could experience a material adverse effect on our business, results of operations, financial condition and prospects.

We are dependent on third-party technology, the loss of which would harm our business.

Third parties provide us access to technologies that are used in our current products and in products under development. Consequently, we rely upon these third parties to develop, introduce and maintain technologies that continue to enhance our current products and enable us, in turn, to develop our own products on a timely and cost-effective basis to meet changing customer needs and technological trends in the orthopedic industry.  In many cases, we do not have supply contracts with these technology suppliers, and we purchase from them on a purchase order basis; therefore, we do not have guaranteed access to such technologies for the intended lifecycles of the products in which such technologies are incorporated.  Additionally, these technology suppliers may go out of business or may be subject to, among other things, injunctions, interruptions in supply, work stoppages or natural disasters, which prevent them from being able to supply their technologies to us.  Additionally, particular technologies may evolve due to changes in industry standards or changes in the market, and, because we do not have long-term contractual commitments with certain of our technology suppliers, we may not have access to the evolved technologies.  If we could not obtain required technology from a supplier, whether on reasonable terms or at all, our business and results of operations would be materially and adversely affected.

Any impairment in our relationships with the licensors of technologies used in our products would force us to find other developers on a timely basis or develop our own technology, which could cause us to cease sales of the affected product for a significant period of time. For example, we estimate that it would take us from approximately 18 to 24 months to re-engineer and reintroduce a product if we lost our existing licenses to certain technologies used in some of our products.  There is no guarantee that we will be able to obtain the third-party technology necessary to continue to develop and introduce new and enhanced products, that we will obtain third-party technology on commercially reasonable terms or that we will be able to replace third-party technology in the event such technology becomes unavailable, obsolete or incompatible with future versions of our products. We would have severe difficulty competing if we could not obtain or replace the third-party technology used in our products. Any absence or delay in obtaining third-party technology necessary for our products would materially adversely affect our business and operating results.

Acquisitions may result in disruptions to our business or distractions of our management due to the efforts required to integrate acquired personnel and operations, and there is no assurance that any such integration will proceed as planned.

We have historically acquired companies, technologies and products intended to expand our business, and we plan to do so in the future. Acquisitions involve a number of special problems and risks, including:

 

·

difficulty integrating acquired technologies, products, services, operations and personnel with the existing businesses;

 

·

difficulty maintaining relationships with important third parties, including those relating to marketing alliances and providing preferred partner status and favorable pricing;

 

·

diversion of management's attention in connection with both negotiating the acquisitions and integrating the businesses;

 

·

strain on managerial and operational resources as management tries to oversee larger operations;

 

·

inability to retain and motivate management and other key personnel of the acquired businesses;

 

·

exposure to unforeseen liabilities of acquired companies, as well as risk of potential litigation arising from such acquisitions;

 

·

potential costly and time-consuming litigation, including shareholder lawsuits;

 

·

potential issuance of securities to equity holders of the company being acquired with rights that are superior to the rights of holders of our common stock, or which may have a dilutive effect on our common shareholders;

21


 

 

·

the need to incur additional debt or use cash; and 

 

·

the requirement to record potentially significant additional future operating costs for the amortization of intangible assets.

As a result of our growth and intent to acquire businesses, we could experience significant strain on internal resources impacting the design and effectiveness of certain internal control processes. As a result of these or other problems and risks, businesses we acquire may not produce the revenues, earnings or business synergies that we anticipated, and acquired products, services or technologies might not perform as we expected. As a result, we may incur higher costs and realize lower revenues than we had anticipated. We may not be able to successfully address these problems and we cannot assure you that the acquisitions will be successfully identified and completed or that, if acquisitions are completed, the acquired businesses, products, services or technologies will generate sufficient revenue to offset the associated costs or other harmful effects on our business.

Any of these risks can be greater if an acquisition is large relative to the size of our company. Failure to effectively manage our growth through acquisitions could adversely affect our prospects, business, results of operations and financial condition.

We have significant goodwill and other intangible assets. Consequently, potential impairment of goodwill and other intangibles may significantly impact our profitability.

We prepare our financial statements in conformity with U.S. generally accepted accounting principles, or U.S. GAAP. U.S. GAAP requires us to annually evaluate whether certain assets have been impaired. Annually, and more frequently if a triggering event occurs, we must test the carrying value of goodwill for impairment using a fair-value-based approach. In addition, U.S. GAAP also requires us to evaluate the carrying value of all long-lived intangible assets other than goodwill whenever events or circumstances indicate that the carrying value of assets may exceed their recoverable amounts. An impairment loss on long-lived intangible assets other than goodwill is recognized when the undiscounted estimated future cash flows expected to result from the use of an asset are less than the carrying amount of the asset. One or more impairment losses could adversely affect our financial condition and results of operations.

We are dependent on key personnel and the loss of these key personnel, or our inability to hire and retain qualified personnel, could have a material adverse effect on our success.

We are highly dependent on the skills, experience and services of key personnel. The loss of key personnel could have a material adverse effect on our business, operating results or financial condition. If Dr. William Petty, our Executive Chairman, unexpectedly terminates his employment with Exactech for any reason, his absence could have a material adverse effect on our business, results of operation and financial condition. We do not maintain key-man life insurance on key individuals. We expect that our anticipated growth and expansion will place increased demands on our management skills and resources. Therefore, our success also depends upon our ability to recruit, hire, train and retain additional skilled and experienced management personnel. Employment and retention of qualified personnel is important due to the competitive nature of our industry. Our inability to hire new personnel with the requisite skills could impair our ability to manage and operate our business effectively.

Our business is subject to complex and stringent regulation in the U.S. and internationally.

We are subject to complex and stringent healthcare, manufacturing, environmental, security, labor, employment and other governmental laws and regulations, both in the United States and in the other countries in which we operate. In addition, our business is impacted by laws and regulations that affect global trade, including tariff and trade policies, export requirements, taxes and other restrictions and charges. Changes in laws, regulations and the related interpretations may alter the landscape in which we do business and may affect our costs of doing business. The impact of new laws and regulations cannot be predicted. Compliance with new and existing laws and regulations may continue to increase our operating costs or require significant capital expenditures. Any failure to comply with applicable laws or regulations in the United States or in any of the countries in which we operate could result in substantial fines or possible revocation of our authority to conduct our operations, which could adversely affect our financial performance.

22


 

The international component of our business has been growing, and difficulties presented by international economic, political, legal, accounting and business conditions could harm our business, including restrictions under our current credit facility.

We have expanded the international component of our business over the last number of years. For the years ended December 31, 2015, 2014, and 2013, we generated 30%, 33% and 33% of our total revenues, respectively, in countries other than the United States. Some risks inherent in conducting business internationally include:

 

·

unexpected changes in regulatory, tax and political environments;

 

·

longer payment cycles and problems collecting accounts receivable;

 

·

financial instability of government payers in some markets;

 

·

fluctuations in currency exchange and interest rates;

 

·

our ability to secure and maintain the necessary physical infrastructure;

 

·

challenges in staffing and managing foreign operations;

 

·

healthcare laws and regulations may be more restrictive than those currently in place in the United States;

 

·

changes in third-party reimbursement policy that may require some of the patients who receive our implant products to directly absorb medical costs or that may necessitate our reducing selling prices for our products; and

 

·

our inability to successfully transition to a significant international platform, including the establishment of internal operational, supply and distribution capabilities.

Additionally, our current credit facility contains limits on the aggregate amount of funding that we may provide to our foreign subsidiaries, which may impair our ability to grow our international operations.

Any one or more of these factors could materially and adversely affect revenues, liquidity and results of operations.

We are subject to various laws relating to trade, export controls, and foreign corrupt practices, the violation of which could adversely affect our operations, reputation, business, prospects, operating results and financial condition.

We must comply with all applicable international trade, export and import laws and regulations of the United States and other countries, and we are subject to export controls and economic sanctions laws and embargoes imposed by the U.S. Government. Changes in trade sanctions laws may restrict our business practices, including cessation of business activities in sanctioned countries or with sanctioned entities, and may result in modifications to compliance programs. We are also subject to the Foreign Corrupt Practices Act, referred to as the FCPA, and other anti-bribery laws that generally prohibit the offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action, or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls.

Our business is heavily regulated and therefore involves significant interaction with public officials, including officials of non-U.S. governments.  We have implemented safeguards and policies to discourage practices by our employees and agents that would violate the FCPA and other applicable laws. However, we cannot ensure that our compliance controls, policies, and procedures will in every instance protect us from acts committed by our employees, agents, contractors, or collaborators that would violate the laws or regulations of the jurisdictions in which we operate.

Violations of these laws and regulations could result in significant fines (up to $2.0 million per violation of the anti-bribery provisions and fines and penalties of up to $25.0 million per violation for violations of the books and

23


 

records requirements), criminal sanctions against us, our officers, or our employees, requirements to obtain export licenses, disgorgement of profits, cessation of business activities in sanctioned countries, implementation of compliance programs, exclusion from government programs, prohibitions on the conduct of our business, and our inability to market and sell our products in one or more countries.  Additionally, any such violations could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees, and our business, prospects, operating results, and financial condition.

Privacy concerns could result in regulatory changes and impose additional costs and liabilities on us, limit our use of information, and adversely affect our business.

Personal privacy has become a significant issue in the United States, Europe, and many other countries where we operate. Many federal, state, and foreign legislatures and government agencies have imposed or are considering imposing restrictions and requirements about the collection, use, and disclosure of personal information obtained from individuals. Changes to laws or regulations affecting privacy could impose additional costs and liability on us and could limit our use of such information to add value for customers. If we were required to change our business activities or revise or eliminate services, or to implement burdensome compliance measures, our business and results of operations could be harmed.  In addition, we may be subject to fines, penalties, and potential litigation if we fail to comply with applicable privacy regulations. The European Union and many countries in Europe have stringent privacy laws and regulations, which may adversely impact our ability to profitably operate in certain European countries. Regulatory burdens of this sort increase our costs and harm our financial results.

Our stock price may be volatile, and you could lose all or part of your investment.

The market price of our common stock on the NASDAQ Global Market has been volatile, fluctuating from a low of $16.11 per share to a high of $26.20 per share during the 52-week trading period ended February 26, 2016, and we may continue to experience significant volatility in the market price of our common stock. Factors that could cause the market price of our common stock to fluctuate significantly include, but are not limited to the following:

 

·

actual or anticipated variations in our quarterly and annual results of operations;

 

·

the failure of our results of operations to meet the expectations of public market analysts or investors;

 

·

changes in market valuations of companies in our industry;

 

·

changes in expectations of future financial performance or changes in estimates of securities analysts;

 

·

adverse regulatory or legal proceedings;

 

·

general market conditions;

 

·

future issuances of common stock or other securities;

 

·

the addition or departure of key personnel; and

 

·

announcements by us or our competitors of acquisitions, investments or strategic alliances.

This volatility could cause the market price of our common stock to decrease and could cause shareholders to lose some or all of their investment in our common stock.

Our common shares are thinly traded and, therefore, relatively illiquid.

As of February 26, 2016, we had 14,027,809 common shares outstanding. While our common stock is traded on the NASDAQ Global Market, our stock is thinly traded (approximately 0.41%, or 57,437 shares, of our stock traded on an average daily basis during the 52 week trading period ended February 26, 2016) and you may have difficulty in selling your shares quickly. The low trading volume of our common stock is outside of our control, and may not increase in the future or, even if it does increase in the future, may not be maintained.

Existing shareholders' interest in us may be diluted by additional issuances of equity securities.

We expect to issue additional equity securities to fund acquisitions and pursuant to employee benefit plans. We may also issue additional equity for other purposes. These securities we issue may have the same rights as our

24


 

common stock or, alternatively, may have dividend, liquidation, or other preferences to our common stock. The issuance of additional equity securities will dilute the holdings of existing shareholders and may reduce the share price of our common stock.

We have not paid, and we do not expect to pay dividends on our common stock, and investors will be able to receive cash in respect of their shares of common stock only upon the sale of the shares.

We have no intention in the foreseeable future to pay any cash dividends on our common stock, and our current credit facility contains certain restrictions on our ability to pay cash dividends.  Therefore, an investor in our common stock may obtain an economic benefit from the common stock only after an increase in its trading price and only by selling the common stock.

Directors, executive officers, principal shareholders and affiliated entities own a significant percentage of our capital stock, and they may make decisions that an investor may not consider to be in the best interests of our shareholders.

Our directors, executive officers, principal shareholders and affiliated entities beneficially own, in the aggregate, approximately 29% of our outstanding common stock. As a result, if some or all of them acted together, they would have the ability to exert substantial influence over the election of our Board of Directors and the outcome of issues requiring approval by our shareholders. This concentration of ownership may have the effect of delaying or preventing a change in control of our company that may be favored by other shareholders. This could prevent the consummation of transactions favorable to other shareholders, such as a transaction in which shareholders might otherwise receive a premium for their shares over current market prices.

Our business and customers may be subject to use taxes and other taxes.

The application of indirect taxes (such as use tax, value-added tax (VAT), goods and services tax, business tax, and gross receipt tax) to the surgical instrumentation we provide in connection with the orthopaedic implant devices we manufacture is a complex and evolving issue. Many of the fundamental statutes and regulations are vague as to whether their application is appropriate in this arena. In many cases, it is not clear how existing statutes apply to the provision of surgical instrumentation. The application of such statutes and regulations, particularly as many states seek avenues with which they may expand revenues generated from broader taxes, could adversely affect our business as it would result in the imposition of use taxes, as well as costs associated with complex tax collection, remittance and audit compliance requirements on us and our dealers and would impact the cost profile of our surgical instrumentation. From time to time, some taxing authorities have notified us that they believe we owe them certain taxes. We are currently contesting these determinations. We continue to work with the relevant tax authorities to clarify our obligations under these laws and regulations.

Failure to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business and operating results. In addition, current and potential shareholders could lose confidence in our financial reporting, which could have a material adverse effect on the price of our common stock.

Effective internal controls are necessary for us to provide reliable financial reports and effectively prevent fraud. If we cannot provide reliable financial reports or prevent fraud, our results of operation could be harmed. Section 404 of the Sarbanes-Oxley Act of 2002 requires annual management assessments of the effectiveness of our internal controls over financial reporting and a report by our independent registered public accounting firm addressing these assessments. If it is determined that we are not in compliance with Section 404, we may be required to implement new internal control procedures and reevaluate our financial reporting. We may experience higher than anticipated operating expenses as well as increased independent auditor fees during the implementation of these changes and thereafter. Further, we may need to hire additional qualified personnel. In addition, if we fail to maintain the adequacy of our internal controls, as such standards are modified, supplemented or amended from time to time, we may not be able to conclude on an ongoing basis that we have effective internal controls over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act, which could result in our being unable to obtain an unqualified report on internal controls from our independent auditors. Failure to achieve and maintain an effective internal control environment could also cause investors to lose confidence in our reported financial information, which could have a material adverse effect on the price of our common stock.

25


 

Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses, or divert management's attention from operating our business which could have a material adverse effect on our business.

Laws, regulations and standards relating to corporate governance and public disclosure are subject to change, and new regulations may be promulgated by the SEC and the securities exchanges, including the NASDAQ Global Market, on which our common stock is or may be listed. These new or changed laws, regulations and standards are subject to varying interpretations in many cases due to their lack of specificity, and as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies, which could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. As a result, our efforts to comply with evolving laws, regulations and standards are likely to continue to result in increased general and administrative expenses and a diversion of management time and attention from revenue-generating activities to compliance activities. Our board members, Chief Executive Officer and Chief Financial Officer could face an increased risk of personal liability in connection with the performance of their duties. As a result, we may have difficulty attracting and retaining qualified board members and executive officers, which could have a material adverse effect on our business. If our efforts to comply with new or changed laws, regulations and standards differ from the activities intended by regulatory or governing bodies, we may incur additional expenses to comply with standards set by regulatory authorities or governing bodies which would have a material adverse effect on our business and results of operations.

ITEM 1B.

UNRESOLVED STAFF COMMENTS

None.

ITEM 2.

PROPERTIES

We own or lease the following properties:

 

 

 

 

 

 

 

 

Owned Property

 

 

 

 

 

 

Facility

 

Location

 

Square Feet

 

Headquarters, research & development  and manufacturing

 

Gainesville, FL

 

 

206,000

 

Sales office and warehouse

 

Illkirch, France

 

 

5,000

 

Warehouse in Spain

 

Gijón, Spain

 

 

3,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Leased Property

 

 

 

 

 

 

 

 

 

 

 

Facility

 

Location

 

Square Feet

 

 

Annual Rental ($)

 

 

Sales Offices

 

United States

 

 

3,500

 

 

 

48,000

 

 

Manufacturing Shops

 

Sarasota, FL

 

 

23,125

 

 

 

245,000

 

 

Warehouse

 

Gainesville, FL

 

 

4,000

 

 

 

16,000

 

 

International Headquarters and Warehouse

 

Switzerland

 

 

12,000

 

 

 

231,000

 

(1)

Canada Sales Office

 

Canada

 

 

1,120

 

 

 

26,000

 

 

Research Office

 

Taiwan

 

 

849

 

 

 

15,000

 

(1)

Sales Office and Warehouse

 

Japan

 

 

4,599

 

 

 

127,000

 

(1)

Sales Office and Warehouse

 

China

 

 

6,342

 

 

 

162,000

 

(1)

Sales Office

 

France

 

 

3,714

 

 

 

30,000

 

(1)

Sales Offices

 

Spain

 

 

11,832

 

 

 

162,000

 

(1)

Sales Office and Warehouse

 

Germany

 

 

2,000

 

 

 

26,000

 

(1)

Sales Office and Warehouse

 

England

 

 

800

 

 

 

30,000

 

(1)

 

 

 

 

 

 

 

 

 

 

 

 

 

(1)

Annual lease amounts are translated into U.S. Dollars using December 31, 2015 exchange rates.

In addition to the above, we own approximately thirteen and one-half acres of land near our existing facilities in Gainesville, Florida that we may use for future expansion.

26


 

ITEM 3.

LEGAL PROCEEDINGS 

There are various claims, lawsuits, and disputes with third parties and pending actions involving various allegations against us incident to the operation of our business, principally product liability cases. While we believe that the various claims are without merit, we are unable to predict the ultimate outcome of such litigation. We therefore maintain insurance, subject to self-insured retention limits, for all such claims, and establish accruals for product liability and other claims based upon our experience with similar past claims, advice of counsel and the best information available. At December 31, 2015 and December 31, 2014, we had $100,000 and $135,000 accrued for product liability claims, respectively. These matters are subject to various uncertainties, and it is possible that they may be resolved unfavorably to us. However, while it is not possible to predict with certainty the outcome of the various cases, it is the opinion of management that, upon ultimate resolution, the cases will not have a material adverse effect on our consolidated financial position, results of operations or cash flows.

Our insurance policies covering product liability claims must be renewed annually. Although we have been able to obtain insurance coverage concerning product liability claims at a cost and on other terms and conditions that are acceptable to us, we may not be able to procure acceptable policies in the future.

The five year term of our Corporate Integrity Agreement, or CIA, entered into with the Office of the Inspector General of the United States Department of Health and Human Services (OIG) on December 7, 2010, expired in December 2015. We are awaiting the OIG’s approval of our compliance with its terms. We continue to enhance and apply our corporate compliance program, and we monitor our practices on an ongoing basis to ensure that we have in place proper controls necessary to comply with applicable laws in the jurisdictions in which we do business. Our failure to maintain compliance with U.S. healthcare and regulatory laws could expose us to significant liability including, but not limited to, exclusion from federal healthcare program participation, including Medicaid and Medicare, civil and criminal fines or penalties, and additional litigation cost and expense.

ITEM 4.

MINE SAFETY DISCLOSURES

Not Applicable

 

 

27


 

PART II

ITEM 5.

MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Our common stock trades on the Nasdaq Global Select Market under the symbol “EXAC”.  The following table sets forth, for the periods indicated, the high and low sales prices of our common stock, as reported on the Nasdaq Global Select Market:

 

2015

 

High

 

 

Low

 

First Quarter

 

$

26.14

 

 

$

20.50

 

Second Quarter

 

 

26.20

 

 

 

20.31

 

Third Quarter

 

 

21.61

 

 

 

16.12

 

Fourth Quarter

 

 

19.40

 

 

 

16.11

 

 

 

 

 

 

 

 

 

 

2014

 

High

 

 

Low

 

First Quarter

 

$

25.14

 

 

$

21.02

 

Second Quarter

 

 

26.52

 

 

 

20.85

 

Third Quarter

 

 

26.30

 

 

 

22.00

 

Fourth Quarter

 

 

24.75

 

 

 

19.87

 

 

We have paid no cash dividends to date on our common stock.  We intend to retain all future earnings for the operation and expansion of our business and do not anticipate the payment of cash dividends in the foreseeable future.  Any future determination as to the payment of cash dividends will depend upon a number of factors, including our future earnings, results of operations, capital requirements, financial condition and any restrictions under credit agreements existing from time to time, as well as such other factors as the Board of Directors may deem relevant.  Our current revolving line of credit limits our ability to pay dividends. See Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Financial Condition, Liquidity and Capital Resources.”

As of February 26, 2016 we had approximately 178 shareholders of record.  

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

None.

28


 

Performance Graph

The following graph compares the cumulative total shareholder return on our common stock for the period from December 31, 2010 to December 31, 2015 with (i) the Nasdaq Stock Market index prepared by Zacks Investment Research, Inc. ("Zacks"), and (ii) Zack's index (the "SIC Index") for companies with our Standard Industry Code.

The graph assumes an investment of $100 in our common stock and each of the indices for the period from December 31, 2010 to December 2015. The comparisons set forth in the graph are provided pursuant to SEC rules and are not intended to forecast or be indicative of the future performance of our common stock or either of the included indices.

The performance graph shall not be deemed incorporated by reference by any general statement incorporating by reference this annual report into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent we specifically incorporate this information by reference, and shall not otherwise be deemed filed under such acts.

 

 

Index

 

2010

 

 

2011

 

 

2012

 

 

2013

 

 

2014

 

 

2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exactech

 

 

100.00

 

 

 

87.51

 

 

 

90.06

 

 

 

126.25

 

 

 

125.24

 

 

 

96.44

 

NASDAQ Stock Market

 

 

100.00

 

 

 

100.53

 

 

 

118.93

 

 

 

165.67

 

 

 

191.02

 

 

 

205.74

 

NASDAQ Medical Equipment Index

 

 

100.00

 

 

 

114.89

 

 

 

127.90

 

 

 

149.90

 

 

 

173.89

 

 

 

204.97

 

 

 

29


 

ITEM 6.

SELECTED FINANCIAL DATA 

The selected financial data set forth below has been derived from our audited consolidated financial statements.  This data should be read together with the audited consolidated financial statements, the notes thereto and “Management's Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this report.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year Ended December 31,

 

(in thousands, except per share amounts)

 

2015

 

 

2014

 

 

2013

 

 

2012

 

 

2011

 

Statement of Income Data:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

241,838

 

 

$

248,373

 

 

$

237,088

 

 

$

224,337

 

 

$

205,397

 

Cost of goods sold

 

 

73,639

 

 

 

74,244

 

 

 

73,019

 

 

 

68,731

 

 

 

64,847

 

Gross profit

 

 

168,199

 

 

 

174,129

 

 

 

164,069

 

 

 

155,606

 

 

 

140,550

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

87,095

 

 

 

89,796

 

 

 

84,999

 

 

 

81,979

 

 

 

77,243

 

General and administrative

 

 

22,483

 

 

 

22,692

 

 

 

21,149

 

 

 

20,139

 

 

 

21,969

 

Research and development

 

 

19,384

 

 

 

18,377

 

 

 

17,802

 

 

 

16,803

 

 

 

13,059

 

Depreciation and amortization

 

 

16,940

 

 

 

16,990

 

 

 

16,190

 

 

 

15,343

 

 

 

14,455

 

Total operating expenses

 

 

145,902

 

 

 

147,855

 

 

 

140,140

 

 

 

134,264

 

 

 

126,726

 

Income from operations

 

 

22,297

 

 

 

26,274

 

 

 

23,929

 

 

 

21,342

 

 

 

13,824

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

 

(1,304

)

 

 

(1,095

)

 

 

(1,215

)

 

 

(1,445

)

 

 

(1,117

)

Other income (expense)

 

 

468

 

 

 

78

 

 

 

138

 

 

 

87

 

 

 

97

 

Foreign currency exchange (loss) gain

 

 

(1,131

)

 

 

(1,129

)

 

 

(444

)

 

 

(90

)

 

 

506

 

Income before provision for income taxes

 

 

20,330

 

 

 

24,128

 

 

 

22,408

 

 

 

19,894

 

 

 

13,310

 

Provision for income taxes

 

 

5,563

 

 

 

7,640

 

 

 

7,036

 

 

 

7,153

 

 

 

4,484

 

Net income

 

 

14,767

 

 

 

16,488

 

 

 

15,372

 

 

 

12,741

 

 

 

8,826

 

Basic earnings per common share

 

$

1.05

 

 

$

1.20

 

 

$

1.14

 

 

$

0.96

 

 

$

0.67

 

Diluted earnings per common share

 

$

1.04

 

 

$

1.18

 

 

$

1.12

 

 

$

0.96

 

 

$

0.67

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

2015

 

 

2014

 

 

2013

 

 

2012

 

 

2011

 

Balance Sheet Data:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total current assets

 

$

141,357

 

 

$

139,157

 

 

$

142,559

 

 

$

130,218

 

 

$

119,231

 

Total assets

 

 

277,242

 

 

 

261,040

 

 

 

261,842

 

 

 

245,141

 

 

 

232,612

 

Total current liabilities

 

 

24,825

 

 

 

26,205

 

 

 

30,517

 

 

 

31,562

 

 

 

27,068

 

Total long-term debt, net of current portion

 

 

16,000

 

 

 

20,250

 

 

 

33,982

 

 

 

38,447

 

 

 

45,917

 

Total liabilities

 

 

48,853

 

 

 

49,669

 

 

 

69,418

 

 

 

74,244

 

 

 

77,285

 

Total shareholders' equity

 

 

228,389

 

 

 

211,371

 

 

 

192,424

 

 

 

170,897

 

 

 

155,327

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

30


 

Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations 

The following discussion should be read in conjunction with the consolidated financial statements and related notes appearing elsewhere in this report.

Overview of the Company

We develop, manufacture, market and sell orthopaedic implant devices, related surgical instrumentation, supplies and biologic materials to hospitals and physicians in the United States and internationally. Our revenues are principally derived from sales of extremity, knee, and hip joint replacement systems and spinal fusion products. We believe that our research and development projects will enable us to continue to introduce both extensions to our existing product families, as well as new reconstructive product lines to address challenging clinical issues. Revenue from sales of other products, including surgical instrumentation, Cemex® bone cement, the InterSpace™ pre-formed, antibiotic cement hip, knee and shoulder spacers are expected to continue to contribute to our anticipated future revenue growth.

Our operating expenses consist of sales and marketing expenses, general and administrative expenses, research and development expenses, and depreciation expenses. The largest component of operating expenses, sales and marketing expenses, primarily consists of payments made to independent sales representatives for their services to hospitals and surgical facilities on our behalf. These expenses tend to be variable in nature and related to sales growth. Research and development expenses primarily consist of expenditures on projects concerning knee, extremities, spine and hip implant product lines and biologic materials and services.

In marketing our products, we use a combination of traditional targeted media advertising together with our primary marketing focus, direct customer contact and service to orthopaedic surgeons. Because surgeons are the primary decision makers when it comes to the choice of products and services that best meet the needs of their patients, we focus our marketing strategy on meeting the needs of the orthopaedic surgeon community. In addition to surgeon’s preference, hospitals and buying groups, as the economic customers, actively participate with physicians in the choice of implants and services.

Overview of 2015

During the twelve months ended December 31, 2015, sales decreased 3% to $241.8 million from $248.4 million in the comparable twelve months ended December 31, 2014, primarily due to the effects of currency exchange rates against the U.S. dollar (USD). Domestic sales for the year ended December 31, 2015 increased 2%, to $168.1 million from $165.6 million for the same period for 2014. As a percentage of sales, domestic sales were 70% for the year ended December 31, 2015 compared to 67% for the year ended December 31, 2014. Gross margins decreased to 69.6% for the year ended December 31, 2015, as compared to 70.1% for the year ended December 31, 2014. The decrease in gross margins was primarily a result of pricing pressures and foreign currency fluctuations. Operating expenses during 2015 decreased 1% from 2014, and, as a percentage of sales, operating expenses increased to 60.4% during 2015 as compared to 59.5% for 2014. Net income for the twelve months ended December 31, 2015 decreased 10% to $14.8 million, and diluted earnings per share were $1.04 as compared to $1.18 during 2014.

At the end of 2015, working capital increased 3% to $116.5 million from $113.0 million as of December 31, 2014. The increase in working capital was primarily a result of increases in cash and accounts receivable. During the twelve months ended December 31, 2015, we acquired $19.5 million in property and equipment, including new surgical instrumentation, production equipment and property in the United States. Comparatively, we acquired $18.2 million in property and equipment for the year ended December 31, 2014. Net cash flow from operations was $28.1 million for the year ended December 31, 2015, as compared to net cash flow from operations of $32.0 million during the year ended December 31, 2014. The decrease in operating cash flow was primarily a result of increased accounts receivable balances at the end of 2015, primarily due to increased domestic sales in the last quarter of 2015.

Recent Events

Effective February 1, 2016, we completed the acquisition of all of the outstanding capital stock of Exactech Australia Pty Ltd, an Australia-based company. Exactech Australia has been our independent importer and distribution partner in Australia for the past four years. The acquisition was accomplished to further the partnership between us and the team at Exactech Australia and to expand our presence in the Australian

31


 

marketplace. The aggregate purchase price for Exactech Australia will range from $3.0 million Australian Dollars (AUD) to $7.6 million AUD, of which we paid $1.6 million AUD, or $1.1 million USD at a 0.71 AUD:USD exchange rate, to the Exactech Australia shareholders in cash at the closing of the acquisition, and the remainder will be paid to such shareholders contingent on the achievement of certain future milestones. We expect the contingent payments to be paid over the next two years. We are currently awaiting finalization of Exactech Australia’s closing balance sheet to complete purchase accounting.

During December 2015, our directors approved a plan to repurchase up to 1.0 million shares of Exactech stock over the next two years. During the first quarter of 2016, we repurchased 150,000 shares of our common stock at an average purchase price of $18.62 per share.

The following table includes: (i) items from the Consolidated Statements of Income for the year ended December 31, 2015, as compared to 2014, and the dollar and percentage change from year to year and the percentage relationship to net sales, and (ii) items from the Consolidated Statements of Income for the year ended December 31, 2014 as compared to 2013, and the dollar and percentage change from year to year and the percentage relationship to net sales:

 

(dollars in thousands)

 

Years Ended December 31,

 

 

2015 – 2014

Inc (decr)

 

 

2014 – 2013

Inc (decr)

 

 

% of Sales

 

 

 

2015

 

 

2014

 

 

2013

 

 

$

 

 

%

 

 

$

 

 

%

 

 

2015

 

 

2014

 

 

2013

 

Net sales

 

$

241,838

 

 

$

248,373

 

 

$

237,088

 

 

 

(6,535

)

 

 

(2.6

)

 

 

11,285

 

 

 

4.8

 

 

 

100.0

%

 

 

100.0

%

 

 

100.0

%

Cost of goods sold

 

 

73,639

 

 

 

74,244

 

 

 

73,019

 

 

 

(605

)

 

 

(0.8

)

 

 

1,225

 

 

 

1.7

 

 

 

30.4

 

 

 

29.9

 

 

 

30.8

 

Gross profit

 

 

168,199

 

 

 

174,129

 

 

 

164,069

 

 

 

(5,930

)

 

 

(3.4

)

 

 

10,060

 

 

 

6.1

 

 

 

69.6

 

 

 

70.1

 

 

 

69.2

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

87,095

 

 

 

89,796

 

 

 

84,999

 

 

 

(2,701

)

 

 

(3.0

)

 

 

4,797

 

 

 

5.6

 

 

 

36.0

 

 

 

36.2

 

 

 

35.9

 

General and administrative

 

 

22,483

 

 

 

22,692

 

 

 

21,149

 

 

 

(209

)

 

 

(0.9

)

 

 

1,543

 

 

 

7.3

 

 

 

9.3

 

 

 

9.1

 

 

 

8.9

 

Research and development

 

 

19,384

 

 

 

18,377

 

 

 

17,802

 

 

 

1,007

 

 

 

5.5

 

 

 

575

 

 

 

3.2

 

 

 

8.1

 

 

 

7.4

 

 

 

7.5

 

Depreciation and amortization

 

 

16,940

 

 

 

16,990

 

 

 

16,190

 

 

 

(50