2016 Annual Report
We improve lives by providing
innovative spine surgery solutions
through our relentless pursuit of
superior outcomes
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
Form 10-K
(Mark One)
(cid:2) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2016
or
(cid:3) 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: 000-52024
ALPHATEC HOLDINGS, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
5818 El Camino Real, Carlsbad,
California
(Address of Principal Executive Offices)
20-2463898
(I.R.S. Employer
Identification No.)
92008
(Zip Code)
(760) 431-9286
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of Each Class
Common Stock, par value $0.0001 per share
Name of Each Exchange on Which Registered
The NASDAQ Global Select Market
Securities registered pursuant to Section 12(g) of the Exchange Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes (cid:3) No (cid:2)
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes (cid:3) No (cid:2)
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 (cid:2) No (cid:3)
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and
post such files). Yes (cid:2) No (cid:3)
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 the
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. (cid:3)
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
definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer
Non-accelerated filer
(cid:3)
(cid:2)(cid:4)(Do not check if a smaller reporting company)
Accelerated filer
Smaller reporting company
(cid:3)
(cid:3)
Indicate by a check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes (cid:3) No (cid:2)
The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant (without admitting that any person whose shares are not
included in such calculation is an affiliate) computed by reference to the price at which the common stock was last sold as of the last business day of the registrant's
most recently completed second fiscal quarter (June 30, 2016), was approximately $24.7 million.
The number of outstanding shares of the registrant’s common stock, par value $0.0001 per share, as of March 24, 2017 was 9,048,145.
DOCUMENTS INCORPORATED BY REFERENCE
None.
ALPHATEC HOLDINGS, INC.
FORM 10-K—ANNUAL REPORT
For the Fiscal Year Ended December 31, 2016
Table of Contents
PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
PART III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV
Item 15.
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Selected Financial Data
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accounting Fees and Services
Exhibits, Financial Statement Schedules
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In this Annual Report on Form 10-K, the terms “we,” “us,” “our,” “Alphatec Holdings” and “Alphatec” mean Alphatec
Holdings, Inc. and our subsidiaries and their subsidiaries. “Alphatec Spine” refers to our wholly-owned operating subsidiary Alphatec
Spine, Inc. “Scient’x” refers to our operating affiliate, Scient’x S.A.S., which is wholly-owned by several of our subsidiaries, and
Scient’x’s subsidiaries.
Item 1.
Business
Overview
PART I
We are a medical technology company focused on the design, development and promotion of products for the surgical treatment
of spinal disorders. Our mission is to improve patient lives by delivering advancements in spinal fusion technologies. We have a
comprehensive product and procedural portfolio, as well as a pipeline that addresses the cervical, thoracolumbar and intervertebral
regions of the spine and covers a variety of spinal disorders from degenerative disease to complex deformity and trauma. Our principal
product offerings are focused on the U.S. market for fusion-based spinal disorder solutions. We believe that our products and
procedural offerings are attractive to surgeons, hospitals, and patients due to innovative features and benefits that are designed to
streamline surgical procedures, improve patient outcomes, while delivering predicable results at lower costs.
Recent Developments
On September 1, 2016, we completed the sale of our international distribution operations and agreements, including our wholly-
owned subsidiaries in Japan, Brazil, Australia, China and Singapore and substantially all of the assets of our other sales operations in
the United Kingdom and Italy, or collectively the International Business, to an affiliate of Globus. Following the closing of the Globus
Transaction, we now operate in the U.S. market only.
Between September 1, 2016 and March 24, 2017, we announced several changes to our senior leadership team, including the
appointment of Terry Rich as our Chief Executive Officer; Craig Hunsaker as our Executive Vice President, People and Culture and
General Counsel; Jon Allen as our Executive Vice President, Commercial Operations; Brian Snider as our Executive Vice President,
Strategic Marketing and Product Development; and Jeff Black as our Executive Vice President, Chief Financial Officer.
On March 29, 2017, we completed a Private Placement of our securities to certain institutional and accredited investors,
including certain directors and executive officers of the Company, providing for the sale by the Company of 1,809,628 shares of our
common stock at a purchase price of $2.00 per share, 15,245 shares of newly designated Series A Convertible Preferred Stock (the
“Series A Convertible Preferred Stock”) at a purchase price of $1,000 per share (which Preferred Shares are convertible into
approximately 7,622,372 shares of our common stock, subject to limitations on conversion until the approval by our stockholders as
required in accordance with the NASDAQ Global Select Market rules), and warrants to purchase up to 9,432,000 shares of our
Common Stock at an exercise price of $2.00 per share (the “Warrants”), in a private placement (the “Private Placement”). The
Warrants will become exercisable following stockholder approval, are subject to certain ownership limitations, and expire five years
after the date of such Stockholder approval. The aggregate gross proceeds for the Private Placement were approximately $18.9
million. We intend to use the net proceeds from the Private Placement for general corporate and working capital purposes.
Strategy
Our goal is to build a high-growth organization focused on innovation and value delivery. By working with world class
surgeons to simplify procedures and deliver better outcomes, we believe that we will be positioned to take a greater share of the U.S.
spine market, becoming the partner of choice for spine surgeons, hospitals, healthcare systems and payors.
To achieve our vision, we are committed to attracting, engaging and retaining the best talent in the industry, and investing in the
following “vital few” strategies:
•
U.S. Commercial Execution and Growth – Dedicated and Loyal Sales Channel
Currently, we market and sell our products in the U.S. through a network of non-exclusive independent distributors and direct
sales representatives. Our goal is to deliver consistent, predictable growth through a durable brand commitment. To accomplish this,
we believe there is significant opportunity for us to partner closely with distributors to create a more dedicated and loyal sales channel
for the future. We are eliminating our stocking distributors and are moving our existing distributor relationships to more dedicated
and non-competitive partnerships. As part of this strategy we intend to add new, high-quality distributors to enable future growth. We
believe this will allow us to reach an untapped market of surgeons, hospitals and national accounts across the U.S., as well as further
penetrate existing accounts and territories. We feel that the recent consolidation in the industry has afforded us the opportunity to
partner with large, seasoned distributors that are looking to re-enter the spine market with our robust product portfolio that is solely
focused in spine solutions.
1
We also employ a national accounts team that is responsible for securing access at hospitals and group purchasing organizations,
or GPOs, across the U.S. We have had strong success with securing access to hospitals and GPOs and today much of our business is
achieved through these accounts. We believe that this access is a key differentiator for us. We will continue to focus our efforts and
investment in developing and maintaining relationships with key GPOs and hospital networks to secure favorable contracts and
develop strategies to convert or grow business within existing accounts.
As part of this effort we are also significantly enhancing our specialized sales training and education programs for independent
distributors and direct sales representatives to enhance overall sales productivity.
•
Reduce Costs and Drive Fiscal Responsibility Across the Organization – Financial Health and Wellness
We plan to embed fiscal responsibility throughout our culture with the goal of remaining disciplined to sustainable standards
and accountability at every level of planning and execution throughout the organization. We are evaluating our existing processes in
order to drive efficiency throughout the organization. We will actively manage our cash and will work to ensure that all cash across
the business is deployed with the goal of increasing free cash flow. We are also striving to drive additional revenue by focusing our
capital spend towards making strategic investments in commercializing our new products.
•
Product Innovation Focus and Position in Spine
We are dedicated to the development, launch and promotion of innovative products that simplify procedures for surgeons and
improve patient outcomes. We support these products through comprehensive sales force and surgeon training and technical support.
Our short-term and long-term pipeline is designed to offer us increased revenue opportunities by addressing the core market segments
of spinal fusion, including both open and minimally invasive surgical, or MIS, pedicle screw systems, interbody devices, cervical
plates and a comprehensive biologics offering.
We are focusing our development and commercialization efforts on differentiated products that we can market through our sales
channel. These innovative products are designed to drive penetration within specific growth segments of the overall spine market,
including the complex spine, deformity, and lateral markets. In Q1 of 2017 we delivered limited market releases of the Arsenal™
Deformity Adolescent Scoliosis (AIS) System, the Battalion Lateral Spacer System, and the Squadron Lateral Retractor. We also plan
to expand our distribution of these offerings as well as broaden our biologics portfolio through structural allograft, tissue and synthetic
bone graft products to support surgeons during the surgical procedure with the goal of achieving high fusion rates.
Spine Anatomy
The spine is the core of the human skeleton and provides important structural support and alignment while remaining flexible to
allow movement. The spine is a column of 33 bones that protects the spinal cord and provides the main support for your body. Each
bony segment of the spine is referred to as a vertebra (two or more are called vertebrae). The spine has five regions containing groups
of similar bones, listed from top to bottom: seven cervical vertebrae in the neck, twelve thoracic vertebrae in the mid-back (each
attached to a rib), five lumbar vertebrae in the lower back, five sacral vertebrae fused together to form one bone in the hip region, and
four coccygeal bones fused together that form the tailbone. At the front of each vertebra is a block of bone called the vertebral body.
Vertebrae are stacked on top of each other and enable people to sit and stand upright. Vertebrae in the cervical, thoracic and lumbar
regions are separated from each other and cushioned by a rubbery soft tissue called the intervertebral disc. Strong muscles and bones,
flexible tendons and ligaments and sensitive nerves contribute to a healthy spine. Pain can be caused when any of these structures are
affected by strain, injury or disease.
The Alphatec Solution
Our principal product offering includes a wide variety of spinal solutions comprised of components such as access systems,
interbody implants, fixation plates, thoracolumbar and cervico/thoracic screws and rods, best-in-class instruments, and various
biologics offerings all designed to enhance and promote spinal fusion. Our business is focused on treating conditions from
degenerative to complex deformity and trauma through a variety of MIS and traditional procedure.
2
The chart below illustrates the principal products in our broad portfolio of spine systems currently available for sale by market
segment. Certain systems and products are described in greater detail below the chart.
* Source: Biomed GPS (SmartTraks), iData, Spine Market, Management estimates
** New product, currently in limited release
*** New product, limited release expected mid-2017
MIS Products
Battalion Lateral Spacer System and Squadron Lateral Retractor
The Battalion Lateral Spacer System with the Alphatec Squadron Lateral Retractor provides surgeons with a next-generation
lateral system with innovative, unique design characteristics including, total blade control technology that allows the surgeon to
maintain approach aperture throughout the procedure, in-situ blade height adjustment and blade replacement, combined with the
Battalion Lateral Spacer is available in 0°and 15° lordosis with a variety of width and height options for lumbar and thoracic
approaches. Our Battalion lateral spacer system and Squadron lateral retractor received clearance of a FDA 510-(k) premarket
notification from the U.S. Food and Drug Administration, or FDA, in 2016 and we began a limited market release launch in February
2017.
XYcor Expandable Spinal Spacer System
The XYcor Expandable Spinal Spacer System provides surgeons with a minimally invasive inspired solution for PLIF and TLIF
procedures by utilizing a smaller, more compact ALIF sized implant that can accommodate a variety of patient pathologies. The
system provides nearly five times the amount of bone graft potential compared to standard PLIF and TLIF cages. Our XYcor system
received FDA 510-(k) clearance in 2016 and we are preparing for limited market release launch in mid 2017.
3
Illico Minimally Invasive Surgery System
The Illico Minimally Invasive Surgery System is a cannulated pedicle screw system that is designed to be inserted via a
minimally invasive surgical procedure. Access to the spine is gained through a small incision. The surgeon is then able to see the
surgical site by using a small canal through which implants are inserted into the patient with a minimum amount of disruption to the
surrounding tissue. We believe that the Illico Minimally Invasive Surgery System limits trauma to the tissue surrounding the location
of the surgery, which is designed to enable patients to recover faster.
BridgePoint Spinous Process Fixation System
The BridgePoint system is a spinous process fixation system that was developed to address the disadvantages of traditional
stabilization devices. The system allows surgeons to fixate the spine using a less invasive approach by attaching a plate to the spinous
process of the vertebral body during spinal fusion surgery.
Thoracolumbar Fixation Products
Arsenal Degenerative System
Arsenal Degenerative Spinal Fixation System is a comprehensive system for both simple and complex degenerative spinal
fusion procedures. The Arsenal Degenerative Spinal Fixation System was designed to provide operational efficiency, biomechanical
strength, and surgical simplicity while providing a complete solution to combat most complex degenerative pathologies. We believe
the combination of low-profile implants, intuitive instrumentation and proven strength of this system are significant advantages. The
Arsenal Degenerative System was designed to be the platform for future development in other spinal fusion segments of the market
including the deformity, MIS and cervico-thoracic segments of the market.
Arsenal Deformity System
The Arsenal Deformity System expands the Arsenal platform to address complex deformity including adult and adolescent
diopathic scoliosis, or AIS, spinal deformity pathologies. The system was thoughtfully designed to provide surgeons with a complete
solution to address complex deformity procedures. The system provides surgeons with unique uniplanar screws, which enable easier
screw positioning and rod placement through a tulip that has 360 degrees of rotation while restricting motion in the medial/lateral
plane for derotation correction. Additionally, the system includes a wide variety of low-profile implants providing a better anatomical
fit and increased ability to address patient pathologies, ergonomically designed instrumentation to improve surgical efficiency and
comfort during complex surgeries and proven biomechanical strength necessary to achieve a solid fusion.
Arsenal CBx Cortical Bone Fixation System
Arsenal CBx is the first extension to the Arsenal platform. An alternative to traditional pedicle screw placement, Arsenal CBx
Cortical Bone Fixation System utilizes a midline approach and cortical bone trajectory to achieve maximum fixation through a less-
invasive procedure. This system leverages the strengths of the Arsenal product platform with the benefits of a minimally disruptive
procedure to enhance patient outcomes.
Due to the midline approach and inward-outward screw trajectory, soft tissue and muscle exposure requirements are greatly
reduced compared to the approach for traditional screw trajectory. Arsenal CBx is a compatible fixation option for both posterior
lumbar interbody fusion or transforaminal lumbar interbody fusion, or PLIF and TLIF, respectively. Additionally, it can be a unique
muscle sparing approach to revision surgery.
Zodiac Degenerative Spinal Fixation System
Our Zodiac Degenerative Spinal Fixation System is a comprehensive spinal system that can be used to address both
degenerative spinal conditions, as well as deformity correction. The system offers polyaxial pedicle screws, accompanying implants
and advanced instruments for the stabilization of the thoracolumbar spine, as well as deformity specific instrumentation and implants
that are designed to enable the surgeon to address patient-specific spinal deformity correction procedures.
4
Cervical and Cervico-Thoracic Products
Trestle Luxe Anterior Cervical Plate System
Our Trestle Luxe Anterior Cervical Plate System has a large window that enables the surgeon to have improved graft site and
end plate visualization, which is designed to allow for better placement of the plate. The Trestle Luxe Anterior Cervical Plate System
also has a low-profile design, which we believe is among the lowest in the spine market. Low-profile cervical plates are intended to
reduce the irritation of the tissue adjacent to the plate following surgery. Other key features of the Trestle Luxe Anterior Cervical Plate
include a self-retaining screw-locking mechanism that is designed to ensure quick and easy locking of the plate and a flush profile
after the screws are inserted.
Solanas Posterior Cervico/Thoracic Fixation System and Avalon Occipital Plate
Our Solanas Posterior Cervico/Thoracic Fixation System consists of rods, polyaxial screws, hooks, and connectors that provide
a solution for posterior cervico/thoracic fusion procedures. We also designed the Solanas Posterior Cervico/Thoracic System to be
used in combination with our existing Zodiac Degenerative Spinal Fixation System and our Avalon Occipital Plate, thereby providing
surgeons with a solution for occipito-cervico-thoracic fixation. The Avalon Occipital Plate has a unique buttress design for optimal
bone graft placement and superior fusion, including three points of plate rotation and translation, which is designed to ease the
placement of the plate.
Interbody Systems
Battalion Universal Spacer System
The Battalion Universal Spacer System offers comfort, control and innovative design for surgeons performing PLIF/TLIF
procedures. The Battalion implants introduce a new alternative to interbody fusion by combining the elasticity and radiolucency of
polyetheretherketone, or PEEK, with a titanium coating for potential osseointegration.
The implants, which come in both a straight and curved footprint, feature a bulleted nose for easy insertion. The Battalion
System also features an intuitive and innovative 180-degree locking inserter that assists with protection of neural elements during
insertion of the implant. To further market potential, the Battalion System features state-of-the-art instrumentation for disc prep,
access and implantation.
Novel PEEK and Titanium Spinal Spacers
Our family of Novel spinal spacers addresses the surgical need to accommodate varying patient anatomies, surgical approaches
and composite material options. We offer multiple unique implant designs, each of which is available in numerous shapes and heights.
Certain of our Novel spinal spacers are made of titanium and others are made of PEEK.
Alphatec Solus Locking ALIF Spinal Spacer
Our Alphatec Solus locking ALIF spinal spacer, or Alphatec Solus, is a zero-profile PEEK and titanium device offering four
points of fixation for improved stability. Alphatec Solus features a one-step insertion and deployment feature and is used in ALIF
procedures. We believe that Alphatec Solus’ locking mechanism is a substantial improvement over similar products currently on the
market.
Biologics
AlphaGraft Structural Allograft Spacers
We offer a broad portfolio of allograft spacers available in a wide range of shapes and sizes, each with corresponding
instrumentation, which are intended for use in the cervical, thoracic, and lumbar regions of the spine. In addition, many of our
allograft spacers are packaged in our vacuum-infusion packaging system, or VIP System. The VIP System is a packaging and fluid
delivery system that allows for fast and efficient infusion of the surgeon’s choice of hydration fluid. The VIP System provides rapid
and uniform hydration, which may reduce the brittleness of the graft and shorten the length of the surgical procedure.
5
AlphaGraft ProFuse Demineralized Bone Scaffold
Our AlphaGraft ProFuse Demineralized Bone Scaffold consists of a sponge-like demineralized bone matrix that has been pre-
cut into sizes to fit within a spinal spacer. The AlphaGraft ProFuse Demineralized Bone Scaffold provides a natural scaffold derived
entirely from bone that can be placed into a void within a spinal spacer or on top of a spinal spacer. The sponge-like qualities of the
scaffold allow a surgeon to compress the scaffold and place it into a small space. Following placement, the scaffold expands for
maximum contact between the spinal spacer and the endplate of the vertebral body and is designed to promote fusion. The AlphaGraft
ProFuse Demineralized Bone Scaffold is pre-packaged in our proprietary VIP System.
Amnioshield Amniotic Tissue Barrier
Our Amnioshield Amniotic Tissue Barrier is an allograft for spinal surgical barrier applications. The composite amniotic
membrane reduces inflammation and enhances healing at the surgical site, reduces scar tissue formation and provides an excellent
dissection plane.
Alphagraft Demineralized Bone Matrix
Our Alphagraft Demineralized Bone Matrix consists of demineralized human tissue that is mixed with a bioabsorbable carrier
and intended for use in surgery for bone grafting.
Neocore Osteoconductive Matrix
Our Neocore Osteoconductive Matrix is designed to provide an effective core environment for bone growth through a synthetic
scaffold. When hydrated with patient bone marrow aspirate, or BMA, Neocore becomes a complete bone graft, which possesses all
the necessary components of bone growth. Engineered to perform like natural bone, Neocore's composition and porosity provide the
benefits of rapid revascularization throughout graft and supports replacement of three-dimensional matrix with healthy new bone
growth. Offering excellent handling characteristics, these pre-formed strips are flexible to conform to adjacent structures,
compressible, and moldable.
Research and Development
Our research and development department seeks to continually improve our core product offering and introduce new products to
increase our penetration in the U.S. spine market. We are focused on developing technology platforms that span the largest market
segments addressing degenerative and deformity spine pathologies. We have transformed our development process by focusing our
resources on two major development programs per year and leveraging integrated teams focused on the key platforms to reduce the
time frame from product concept to market commercialization. We also collaborate with our surgeon partners to design products to
enhance the surgeon experience, simplify surgical techniques, and reduce overall costs, while improving patient outcomes. Our
product development efforts are fully integrated in one facility allowing us to bring products from concept to market rapidly
responding to surgeon and patient needs. Our resources include a technology advancement cell for rapid prototyping, a cadaveric lab,
and mechanical testing laboratory.
Sales and Marketing
We market and sell our products through a sales force consisting of exclusive and non-exclusive independent distributors and
employee direct sales representatives. We employ a team of regional sales managers who are responsible for overseeing the overall
sales channel process in their territories. Although surgeons in the U.S. typically make the ultimate decision to use our products, we
generally bill the hospital for the products that are used and pay commissions to the sales representative or the sales agent based on
payment received from the hospital. We compensate our direct sales employees and regional sales managers through salaries and
incentive bonuses based on performance measures.
In late 2016 we evaluated our sales distribution channel and are currently in the process of making significant changes to drive a
more dedicated and loyal sales channel. Moving forward we intend to eliminate our traditional stocking distributors, move our
existing distributor relationships to more exclusive partnerships and attract new, high-quality distributors to enable future growth. We
believe these changes will provide us with significant opportunity for future growth as we secure more exclusive distribution partners
that can further penetrate existing and new geographic markets.
We evaluate and select our distribution partners and sales employees based on their expertise in selling spinal devices,
reputation within the surgeon community, geographical coverage and established sales network.
6
We also employ a national accounts team that is responsible for securing access at hospitals and GPOs, across the U.S. We have
had strong success with securing access to hospitals and GPOs. We believe this access is a key differentiator for us and much of our
current business is achieved through these accounts. We will continue to focus our efforts and investment on developing and
maintaining relationships with key GPOs and hospital networks to secure favorable contracts and develop strategies to convert or
grow business within existing accounts.
We market our products at various industry conferences, organized surgical training courses, and in industry trade journals and
periodicals.
Surgeon Training and Education
We focus our surgeon training efforts on delivering critical technical skills needed on the entire spinal fusion procedure through
a peer-to-peer approach to qualified surgeon customers. Well-timed surgeon education programs drive customer conversion and
loyalty through leadership and excellence by focusing on delivering value through improved surgeon outcomes. We devote
significant resources to training and education and are committed to a culture of scientific excellence and ethics.
We believe that one of the most effective ways to introduce and build market demand for our products is by training and
educating spine surgeons, independent distributors, and direct sales representatives in the benefits and use of our products. Sales
training programs will be a platform for learning and organizational development, ensuring the sales force is clinically competitive
and considered an essential resource to all stakeholders. We focus on cross functional collaboration and alignment to deliver timely
and relevant programs to meet surgeon and representative needs and positively impact the business.
Our training and education programs are designed to support new product introductions to the market as well as ongoing
portfolio advancement. Our resources are nimble and responsive and include field based engagements to supplement our core
curriculum. We believe this is an effective way to increase overall surgeon adoption of our new products.
We believe that surgeons, independent distributors, and direct sales representatives will become exposed to the merits and
distinguishing features of our products through our training and education programs, and that such exposure will increase the use and
promotion of our products. With a focus on the entire procedure, we expect to build awareness of the breadth of our product offering.
We are conscientious in the pursuit of delivering value to all stakeholders. Our goal is to provide surgeon education programs coupled
with a growing and comprehensive sales training platform that create a sustainable competitive advantage for our organization.
Manufacture and Supply
We rely on third-party suppliers for the manufacture of all our implants and instruments. Outsourcing implant manufacturing
reduces our need for capital investment and reduces operational expense. Additionally, outsourcing provides expertise and capacity
necessary to scale up or down based on demand for our products. We select our suppliers to ensure that all of our products are safe,
effective, adhere to all applicable regulations, are of the highest quality, and meet our supply needs. We employ a rigorous supplier
assessment, qualification, and selection process targeted to suppliers that meet the requirements of the U.S. Food and Drug
Administration, or FDA, and International Organization for Standardization, or ISO, and quality standards supported by internal
policies and procedures. Our quality assurance process monitors and maintains supplier performance through qualification and
periodic supplier reviews and audits.
The raw materials used in the manufacture of our non-biologic products are principally titanium, titanium alloys, stainless steel,
cobalt chrome, ceramic, allograft, and PEEK. With the exception of PEEK, none of our raw material requirements is limited to any
significant extent by critical supply. We are subject to the risk that Invibio, one of a limited number of PEEK suppliers, will fail to
supply PEEK in adequate amounts and in a timely manner. We believe our supplier relationships and quality processes will support
our potential capacity needs for the foreseeable future.
With respect to biologics products, we are FDA-registered and licensed in the states of California, New York, and Florida, the
only states that currently require licenses. Our facility and the facilities of the third-party suppliers we use are subject to periodic
unannounced inspections by regulatory authorities and may undergo compliance inspections conducted by the FDA and corresponding
state and foreign agencies. Because our biologics products are processed from human tissue, maintaining a steady supply can
sometimes be challenging. We have not experienced significant difficulty in locating and obtaining the materials necessary to fulfill
our production requirements, and we have not experienced a meaningful disruption to sales orders.
7
Divestiture of International Business
On September 1, 2016, we closed a sale of our international distribution operations and agreements to Globus Medical Ireland,
Ltd., or the Buyer, a subsidiary of Globus Medical, Inc., or Globus, or the Globus Transaction. Pursuant to the Globus Transaction,
Globus acquired: (i) all of the stock of our wholly-owned subsidiaries in Japan, Brazil, Australia, China and Singapore; (ii)
substantially all of the assets of our other sales operations in the United Kingdom and Italy; and (iii) all of the other assets that are
related to the business of the design, development, marketing, promotion and sale of products for the surgical treatment of spine
disorders that we market and sell outside of the United States. The Globus Transaction was completed pursuant to a purchase and sale
agreement, dated as of July 25, 2016, as amended, or the Purchase and Sale Agreement. Pursuant to the Purchase and Sale Agreement
we have agreed to not market and sell spinal implant products outside of the United States for a period beginning after the closing of
the Globus Transaction and ending two years following the termination of the Supply Agreement defined below.
Under the terms of the Purchase and Sale Agreement, at the closing of the Globus Transaction the Buyer paid us $80 million in
cash, subject to a working capital adjustment. In addition, at the closing of the Globus Transaction we entered into a five-year term
credit facility agreement, or the Globus Facility Agreement, with Globus, pursuant to which Globus agreed to loan us up to $30
million.
In addition, at the closing of the Globus Transaction, we and Globus entered into a product manufacture and supply agreement,
or the Supply Agreement, pursuant to which, at agreed-upon prices, we agreed to supply to Globus certain of our implants and
instruments that at the time were being offered for sale by us outside of the United States. Pursuant to the Supply Agreement, we will
be responsible for ensuring that all of the products delivered to Globus meet all agreed-upon specifications for such products. The
Supply Agreement has an initial term of three years, and Globus has the right to renew the Supply Agreement for two additional 12-
month periods; subject to Globus meeting certain purchase requirements.
Competition
Although we believe that our current broad product portfolio and development pipeline is differentiated and has numerous
competitive advantages, the spinal implant industry is highly competitive, subject to rapid technological change, and significantly
affected by new product introductions. We believe that the principal competitive factors in our market include:
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improved outcomes for spine pathology procedures;
ease of use, quality and reliability of product portfolio;
effective and efficient sales, marketing and distribution;
quality service and an educated and knowledgeable sales network;
technical leadership and superiority;
surgeon services, such as training and education;
responsiveness to the needs of surgeons;
acceptance by spine surgeons;
product price and qualification for reimbursement; and
speed to market.
Both our currently marketed products and any future products we commercialize are subject to intense competition. We believe
that our most significant competitors are Medtronic Sofamor Danek, Johnson & Johnson (DePuy/Synthes), Stryker, NuVasive,
Zimmer, Biomet, Globus, K2M Medical, SeaSpine and others, many of which have substantially greater financial resources than we
do. In addition, these companies may have more established distribution networks, entrenched relationships with physicians and
greater experience in developing, launching, marketing, distributing and selling spinal implant products.
Some of our competitors also provide non-operative therapies for spine disorder conditions. While these non-operative
treatments are considered to be an alternative to surgery, surgery is typically performed in the event that non-operative treatments are
unsuccessful. We believe that, to date, these non-operative treatments have not caused a material reduction in the demand for surgical
treatment of spinal disorders.
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Intellectual Property
We rely on a combination of patent, trademark, copyright, trade secret and other intellectual property laws, nondisclosure
agreements, proprietary information ownership agreements and other measures to protect our intellectual property rights. We believe
that in order to have a competitive advantage, we must develop, maintain and enforce the proprietary aspects of our technologies. We
require our employees, consultants, co-developers, distributors and advisors to execute agreements governing the ownership of
proprietary information and use and disclosure of confidential information in connection with their relationship with us. In general,
these agreements require these individuals and entities to agree to disclose and assign to us all inventions that were conceived on our
behalf or which relate to our property or business and to keep our confidential information confidential and only use such confidential
information in connection with our business.
Patents
As of March 14, 2017, we and our affiliates owned, or exclusively owned 111 issued U.S. patents, 72 pending U.S. patent
applications and 231 issued or pending foreign patents. We own multiple patents relating to unique aspects and improvements for
several of our products. We do not believe that the expiration of any single patent is likely to significantly affect our intellectual
property position.
Trademarks
As of March 14, 2017, we and our affiliates owned 72 registered U.S. trademarks and 148 registered trademarks outside of the
U.S..
Government Regulation
Our products are subject to extensive regulation by the FDA and other U.S. federal and state regulatory bodies and comparable
authorities in other countries. Our products are subject to regulation under the Federal Food, Drug, and Cosmetic Act, or FDCA, and
in the case of our tissue products, also under the Public Health Service Act, or PHSA. To ensure that our products are safe and
effective for their intended use, the FDA regulates, among other things, the following activities that we or our partners perform and
will continue to perform:
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product design and development;
product testing;
non-clinical and clinical research;
product manufacturing;
product labeling;
product storage;
premarket clearance or approval;
advertising and promotion;
product marketing, sales and distribution;
import and export; and
post-market surveillance, including reporting deaths or serious injuries related to products and certain product
malfunctions.
Government Regulation – Medical Devices
FDA’s Premarket Clearance and Approval Requirements
Unless an exemption applies, each medical device we wish to commercially distribute in the United States will require either
FDA clearance of a premarket notification requesting permission for commercial distribution under Section 510(k) of the Federal
Food, Drug and Cosmetic Act, or FDCA, also referred to as a 510(k) clearance, or approval of a premarket approval application, or
PMA. The information that must be submitted to the FDA in order to obtain clearance or approval to market a new medical device
varies depending on how the medical device is classified by the FDA. Under the FDCA medical devices are classified into one of
three classes —Class I, Class II or Class III—depending on the degree of risk associated with the use of the device and the extent of
manufacturer and regulatory controls deemed to be necessary by the FDA to reasonably ensure their safety and effectiveness.
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Class I devices are those with the lowest risk to the patient for which safety and effectiveness can be reasonably assured by
adherence to a set of regulations, referred to as General Controls, which require compliance with the applicable portions of the FDA's
Quality System Regulation, or QSR, facility registration and product listing, reporting of adverse events and malfunctions, and
appropriate, truthful and non-misleading labeling and promotional materials. Some Class I devices also require 510(k) clearance by
the FDA, though most Class I devices are exempt from the premarket notification requirements. Class II devices are those that are
subject to the General Controls, as well as Special Controls, which can include performance standards, product-specific guidance
documents and postmarket surveillance. Manufacturers of most Class II devices are required to submit to the FDA a premarket
notification under Section 510(k) of the FDCA. Class III devices include devices deemed by the FDA to pose the greatest risk such as
life-supporting or life-sustaining devices, or implantable devices, in addition to those deemed not substantially equivalent following
the 510(k) process. The safety and effectiveness of Class III devices cannot be reasonably assured solely by compliance with the
General Controls and Special Controls described above. Therefore, these devices must be the subject of an approved PMA. Both
510(k)s and PMAs are subject to the payment of user fees at the time of submission for FDA review.
If the FDA determines that the device is not "substantially equivalent" to a predicate device following submission and review of
a 510(k) premarket notification, or if the manufacturer is unable to identify an appropriate predicate device and the new device or new
use of the device presents a moderate or low risk, the device sponsor may either pursue a PMA approval or seek reclassification of the
device through the de novo process. Our current products on the market in the U.S. are Class II devices marketed under FDA 510(k)
premarket clearance.
510(k) Clearance Pathway
To obtain 510(k) clearance, we must submit a premarket notification demonstrating that the proposed device is substantially
equivalent to a device legally marketed in the United States. A predicate device is a legally marketed device that is not subject to
premarket approval, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is
not required, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent
through the 510(k) process. To be "substantially equivalent," the proposed device must have the same intended use as the predicate
device, and either have the same technological characteristics as the predicate device or have different technological characteristics
and not raise different questions of safety or effectiveness than the predicate device. Clinical data is sometimes required to support
substantial equivalence.
The FDA’s goal is to review and act on each 510(k) within 90 days of submission, but the process usually takes from nine to 12
months, and it may take longer if the FDA requests additional information. Most 510(k)s do not require supporting data from clinical
trials, but the FDA may request such data. If the FDA agrees that the device is substantially equivalent, it will grant clearance to
commercially market the device.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that
would constitute a new or major change in its intended use, will require a new 510(k) clearance or, depending on the modification,
require premarket approval. The FDA requires each manufacturer to determine whether the proposed change requires the submission
of a 510(k) or PMA, but the FDA can review any such decision and can disagree with a manufacturer’s determination. If the FDA
disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or recall the modified
device until 510(k) clearance or PMA is obtained. If the FDA requires us to seek a new 510(k) clearance or PMA for any
modifications to a previously cleared product, we may be required to cease marketing or recall the modified device until we obtain this
clearance or approval. Also, in these circumstances, we may be subject to significant fines or penalties. We have made and plan to
continue to make enhancements to our products for which we have not submitted 510(k)s or PMAs, and we will consider on a case-
by-case basis whether a new 510(k) or PMA is necessary.
The FDA began to consider proposals to reform its 510(k) marketing clearance process in 2011, and such proposals could
include increased requirements for clinical data and a longer review period. Specifically, in response to industry and healthcare
provider concerns regarding the predictability, consistency and rigor of the 510(k) regulatory pathway, the FDA initiated an evaluation
of the 510(k) program, and as part of the Food and Drug Administration Safety and Innovation Act, or FDASIA, Congress
reauthorized the Medical Device User Fee Amendments with various FDA performance goal commitments and enacted several
“Medical Device Regulatory Improvements” and miscellaneous reforms, which are further intended to clarify and improve medical
device regulation both pre- and post-clearance and approval. Further, in December 2016, the 21st Century Cures Act, or Cures Act,
was signed into law. The Cures Act, among other things, is intended to modernize the regulation of devices and spur innovation, but
its ultimate implementation is unclear.
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Premarket Approval Pathway
Class III devices require PMA approval before they can be marketed, although some pre-amendment Class III devices for which
the FDA has not yet required a PMA are cleared through the 510(k) process. The PMA process is generally more complex, costly and
time consuming than the 510(k) process. A PMA must be supported by extensive data including, but not limited to, extensive
technical information regarding device design and development, preclinical and clinical trials, manufacturing and labeling information
to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device for its intended use. The PMA application must
provide valid scientific evidence that demonstrates to the FDA's satisfaction reasonable assurance of the safety and effectiveness of the
device for its intended use. Following receipt of a PMA, the FDA determines whether the application is sufficiently complete to
permit a substantive review. If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review of
the PMA, although in practice, the FDA’s review often takes significantly longer, and can take up to several years. During this review
period, the FDA may request additional information or clarification of information already provided, and the FDA may issue a major
deficiency letter to the applicant, requesting the applicant's response to deficiencies communicated by the FDA. Also during the
review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and
provide recommendations to the FDA as to the approvability of the device. The FDA may or may not accept the panel’s
recommendation. In addition, the FDA will conduct a preapproval inspection of the manufacturing facility to ensure compliance with
quality system regulation, or QSR. The PMA process can be expensive, uncertain and lengthy, and a number of devices for which
FDA approval has been sought by other companies have never been approved by the FDA for marketing
Clinical Trials
Clinical trials are almost always required to support a PMA and are sometimes required for a 510(k). All clinical investigations
of investigational devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational
device exemption, or IDE, regulations which govern investigational device labeling, prohibit promotion of the investigational device,
and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the
device is determined to present a “significant risk” to human health, the manufacturer may not begin a clinical trial until it submits an
IDE application to the FDA and obtains approval of the IDE from the FDA. The IDE must be supported by appropriate data, such as
animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically
sound. In addition, the study must be approved by, and conducted under the oversight of, an Institutional Review Board, or IRB, for
each clinical site. The IRB is responsible for the initial and continuing review of the IDE, and may pose additional requirements for
the conduct of the study. If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may begin at a
specific number of investigational sites with a specific number of patients, as approved by the FDA. If the device presents a non-
significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without
separate approval from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring
that the investigators obtain informed consent, and labeling and record-keeping requirements. A clinical trial may be suspended by
FDA, the sponsor or an IRB at any time for various reasons, including a belief that the risks to the study participants outweigh the
benefits of participation in the trial. Even if a clinical trial is completed, the results may not demonstrate the safety and efficacy of a
device to the satisfaction of the FDA, or may be equivocal or otherwise not be sufficient to obtain approval of a device.
Pervasive and Continuing FDA Regulation
After a device is placed on the market, numerous FDA and other regulatory requirements continue to apply. These include:
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registration and listing requirements, which require manufacturers to register all manufacturing facilities and list all
medical devices placed into commercial distribution;
the QSR, which requires manufacturers, including third-party contract manufacturers, to follow stringent design, testing,
control, supplier/contractor selection, documentation, record maintenance and other quality assurance controls, during all
aspects of the manufacturing process and to maintain and investigate complaints;
labeling regulations and unique device identification requirements;
advertising and promotion requirements;
restrictions on sale, distribution or use of a device;
FDA prohibitions against the promotion of products for uncleared or unapproved “off-label” uses;medical device
reporting obligations, which require that manufacturers submit reports to the FDA of device may have caused or
contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or
serious injury if it were to reoccur;;
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medical device correction and removal reporting regulations, which require that manufacturers report to the FDA field
corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a
violation of the FDCA that may present a risk to health;
device tracking requirements; and
other post-market surveillance requirements, which apply when necessary to protect the public health or to provide
additional safety and effectiveness data for the device.
Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any
of the following:
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warning letters and untitled letters;
fines, injunctions, consent decrees, and civil penalties;
recalls, withdrawals, administrative detention, or seizure of products;
operating restrictions, partial suspension or total shutdown of production;
withdrawals of 510(k) clearances or PMA approvals that have already been granted;
refusal to grant 510(k) clearance or PMA approvals of new products; and/or
criminal prosecution.
Our facilities, records and manufacturing processes are subject to periodic announced and unannounced inspections by the FDA
to evaluate compliance with applicable regulatory requirements.
Regulation of Human Cells, Tissues, and Cellular and Tissue-based Products
Certain of our products are regulated as human cells, tissues, and cellular and tissue-based products, or HCT/Ps. Section 361 of
the PHSA authorizes the FDA to issue regulations to prevent the introduction, transmission or spread of communicable disease.
HCT/Ps regulated as “361” HCT/Ps are subject to requirements relating to registering facilities and listing products with the FDA,
screening and testing for tissue donor eligibility, or Good Tissue Practice, when processing, storing, labeling, and distributing HCT/Ps,
including required labeling information, stringent record keeping, and adverse event reporting, among other applicable requirements
and laws. If the HCT/P is minimally manipulated, is intended for homologous use only and meets other requirements, the HCT/P will
not require 510(k) clearance, PMA approval, a Biologics License Applications, or other premarket authorization from the FDA before
marketing.
Environmental Matters
Our facilities and operations are subject to extensive federal, state, and local environmental and occupational health and safety
laws and regulations. These laws and regulations govern, among other things, air emissions; wastewater discharges; the generation,
storage, handling, use and transportation of hazardous materials; the handling and disposal of hazardous wastes; the cleanup of
contamination; and the health and safety of our employees. Under such laws and regulations, we are required to obtain permits from
governmental authorities for some of our operations. If we violate or fail to comply with these laws, regulations or permits, we could
be fined or otherwise sanctioned by regulators. We could also be held responsible for costs and damages arising from any
contamination at our past or present facilities or at third-party waste disposal sites. We cannot completely eliminate the risk of
contamination or injury resulting from hazardous materials, and we may incur material liability as a result of any contamination or
injury.
Compliance with Certain Applicable Statutes
We are subject to various federal and state laws pertaining to healthcare fraud and abuse, including anti-kickback laws, false
claims laws, criminal health care fraud laws, physician payment transparency laws, data privacy and security laws and foreign corrupt
practice laws. Violations of these laws are punishable by criminal and/or civil sanctions, including, in some instances, fines,
imprisonment and, within the United States, exclusion from participation in government healthcare programs, including Medicare,
Medicaid and Veterans Administration health programs. These laws are administered by, among others, the U.S. Department of
Justice, the Office of Inspector General of the Department of Health and Human Services and state attorneys general. Many of these
agencies have increased their enforcement activities with respect to medical device manufacturers in recent years.
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The federal Anti-Kickback Statute, prohibits persons from knowingly and willfully soliciting, offering, receiving or providing
remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing, arranging for or
recommending a good or service, for which payment may be made in whole or part under federal healthcare programs, such as the
Medicare and Medicaid programs. The Anti-Kickback Statute is broad and prohibits many arrangements and practices that are lawful
in businesses outside of the healthcare industry. For example, the definition of “remuneration” has been broadly interpreted to include
anything of value, including, gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers
of payments, ownership interests and providing anything at less than its fair market value. In addition, the Patient Protection and
Affordable Health Care Act, which, as amended by the Health Care and Education Reconciliation Act, and collectively referred to as
ACA. ACA, among other things, amends the intent requirement of the federal Anti-Kickback Statute. A person or entity no longer
needs to have actual knowledge of this statute or specific intent to violate it. In addition, ACA provides that the government may
assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent
claim for purposes of the federal False Claims Act.
In implementing the Anti-Kickback Statute, the Department of Health and Human Services Office of Inspector General, or OIG,
has issued a series of regulations, known as the safe harbors, which began in July 1991. These safe harbors set forth provisions that, in
circumstances where all the applicable requirements are met, will assure healthcare providers and other parties that they will not be
prosecuted under the Anti-Kickback Statute. The failure of a transaction or arrangement to fit precisely within one or more safe
harbors does not necessarily mean that it is illegal or that prosecution will be pursued. However, conduct and business arrangements
that do not fully satisfy all requirements of an applicable safe harbor may result in increased scrutiny by government enforcement
authorities such as the OIG. Penalties for violations of the Anti-Kickback Statute include criminal penalties and civil sanctions such as
fines, imprisonment and possible exclusion from Medicare, Medicaid and other federal healthcare programs. Many states have anti-
kickback laws that are similar to the federal law, some of which apply to the referral of patients for healthcare items or services
reimbursed by any source, and may also result in penalties, fines, sanctions for violations, and exclusions from state or commercial
programs.
We have entered into various agreements with certain surgeons that perform services for us, including some who make clinical
decisions to use our products. Some of our referring surgeons own our stock, which they received from us as consideration for
services performed. From time to time, we review these arrangements to determine whether they are in compliance with applicable
laws and regulations. In addition, physician-owned distribution companies, or PODs, have increasingly become involved in the sale
and distribution of medical devices, including products for the surgical treatment of spine disorders. In many cases, these distribution
companies enter into arrangements with hospitals that bill Medicare or Medicaid for the furnishing of medical services, and the
physician-owners are among the physicians who refer patients to the hospitals for surgery. On March 26, 2013 the OIG issued a
Special Fraud Alert entitled "Physician-Owned Entities", or the Fraud Alert, in which the OIG concluded, among other things, that
PODs are "inherently suspect under the anti-kickback statute" and that PODs present "substantial fraud and abuse risk and pose
dangers of patient safety." Since 2013, the OIG has further increased its scrutiny of PODs and the Department of Justice has brought
several high-profile cases against physician owners.
The federal False Claims Act prohibits persons from knowingly filing or causing to be filed a false or fraudulent claim to, or the
knowing use of false statements to obtain payment from, the federal government. Private suits filed under the False Claims Act,
known as qui tam actions, can be brought by individuals on behalf of the government. These individuals, sometimes known as
“relators” or, more commonly, as “whistleblowers,” may share in any amounts paid by the entity to the government in fines or
settlement. The number of filings of qui tam actions has increased significantly in recent years, causing more healthcare companies to
have to defend a False Claim Act action. If an entity is determined to have violated the federal False Claims Act, it may be required to
pay up to three times the actual damages sustained by the government, plus civil penalties of between $10,000 to $22,000 for each
separate false claim and may be subject to exclusion from Medicare, Medicaid and other federal healthcare programs. Various states
have also enacted similar laws modeled after the federal False Claims Act which apply to items and services reimbursed under
Medicaid and other state programs, or, in several states, apply regardless of the payor.
The Health Insurance Portability and Accountability Act, or HIPAA, created two new federal crimes: healthcare fraud and false
statements relating to healthcare matters. The healthcare fraud statute prohibits knowingly and willfully executing a scheme to defraud
any healthcare benefit program, including private payors. The ACA changed the intent requirement of the healthcare fraud statute to
such that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. A violation of this
statute is a felony and may result in fines, imprisonment or possible exclusion from Medicare, Medicaid and other federal healthcare
programs. The false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or
making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits,
items or services. A violation of this statute is a felony and may result in similar sanctions.
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ACA also includes various provisions designed to strengthen significantly fraud and abuse enforcement in addition to those
changes discussed above. Among these additional provisions include increased funding for enforcement efforts and new “sunshine”
provisions to require us to report and disclose to the Centers for Medicare and Medicaid Services, or CMS, any payment or “transfer
of value” made or distributed to physicians or teaching hospitals. These sunshine provisions also require certain group purchasing
organizations, including physician-owned distributors, to disclose physician ownership information to CMS. We and other device
manufacturers are required to collect and annually report specific data on payments and other transfers of value to physicians and
teaching hospitals. There are various state laws and initiatives that require device manufacturers to disclose to the appropriate
regulatory agency certain payments or other transfers of value made to physicians, and in certain cases prohibit some forms of these
payments, with the risk of fines for any violation of such requirements.
HIPAA also includes privacy and security provisions designed to regulate the use and disclosure of “protected health
information”, or PHI, which is health information that identifies a patient and that is held by a health care provider, a health plan or
health care clearinghouse. We are not directly regulated by HIPAA, but our ability to access PHI for purposes such as marketing,
product development, clinical research or other uses is controlled by HIPAA and restrictions placed on health care providers and other
covered entities. HIPAA was amended in 2009 by the Health Information Technology for Economic and Clinical Health Act, or
HITECH, which strengthened the rule, increased penalties for violations and added a requirement for the disclosure of breaches to
affected individuals, the government and in some cases the media. We must carefully structure any transaction involving PHI to avoid
violation of HIPAA and HITECH requirements.
Almost all states have adopted data security laws protecting personal information including social security numbers, state issued
identification numbers, credit card or financial account information coupled with individuals’ names or initials. We must comply with
all applicable state data security laws, even though they vary extensively, and must ensure that any breaches or accidental disclosures
of personal information are promptly reported to affected individuals and responsible government entities. We must also ensure that
we maintain compliant, written information security programs or run the risk of civil or even criminal sanctions for non-compliance as
well as reputational harm for publicly reported breaches or violations.
If any of our operations are found to have violated or be in violation of any of the laws described above and other applicable
state and federal fraud and abuse laws, we may be subject to penalties, among them being civil and criminal penalties, damages, fines,
exclusion from government healthcare programs, and the curtailment or restructuring of our operations.
Third-Party Reimbursement
In the U.S., healthcare providers generally rely on third-party payors, principally private insurers and governmental payors such
as Medicare and Medicaid, to cover and pay for all or part of the cost of a spine surgery in which our medical devices are used. We
expect that sales volumes and prices of our products will depend in large part on the continued availability of reimbursement from
such third-party payors. These third-party payors may deny reimbursement if they determine that a device used in a procedure was not
medically necessary in accordance with cost-effective treatment methods, as determined by the third-party payor, or was used for an
unapproved indication. Particularly in the U.S., third-party payors continue to carefully review, and increasingly challenge, the prices
charged for procedures and medical products. Medicare coverage and reimbursement policies are developed by CMS, the federal
agency responsible for administering the Medicare program, and its contractors. CMS establishes these Medicare policies for medical
products and procedures and such policies are periodically reviewed and updated. While private payors vary in their coverage and
payment policies, the Medicare program is viewed as a benchmark. Medicare payment rates for the same or similar procedures vary
due to geographic location, nature of the facility in which the procedure is performed (i.e., teaching or community hospital) and other
factors. We cannot assure you that government or private third-party payors will cover and provide adequate payment for the
procedures in which our products are used. ACA and other reform proposals contain significant changes regarding Medicare,
Medicaid and other third party payors.
Among these changes was the imposition of a 2.3% excise tax on domestic sales of medical devices that went into effect on
January 1, 2013. This tax has resulted in a significant increase in the tax burden on our industry. In December 2015, the U.S. Congress
adopted and President Obama signed into law the Consolidated Appropriations Act of 2016. Among other things, this legislation put
in place a two-year moratorium on the device tax through the end of 2017. Other elements of the ACA include numerous provisions
to limit Medicare spending through reductions in various fee schedule payments and by instituting more sweeping payment reforms,
such as bundled payments for episodes of care, the establishment of “accountable care organizations” under which hospitals and
physicians will be able to share savings that result from cost control efforts, comparative effectiveness research, value-based
purchasing, and the establishment of an independent payment advisory board.
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We expect that the new Presidential administration and U.S. Congress will seek to modify, repeal, or otherwise invalidate all, or
certain provisions of, the ACA. Since its enactment, there have also been other judicial and Congressional challenges to certain
aspects of the ACA. As a result, there have been delays in the implementation of, and action taken to repeal or replace, certain aspects
of the ACA. In March 2017, the United States House of Representatives introduced legislation known as the American Health Care
Act, or the AHCA, which, if enacted, would amend or repeal significant portions of the ACA. Among other changes, the AHCA,
would repeal the medical device tax, eliminate penalties on individuals and employers that fail to maintain or provide minimum
essential coverage and create refundable tax credits to assist individuals in buying health insurance. The AHCA would also make
significant changes to Medicaid by, among other things, making Medicaid expansion optional for states, repealing the requirement that
state Medicaid plans provide the same essential health benefits that are required by plans available on the exchanges, modifying
federal funding, including implementing a per capita cap on federal payments to states, and changing certain eligibility requirements.
While it is uncertain when or if the provisions in the AHCA will become law, or the extent to which any such changes may impact our
business, it is clear that concrete steps are being taken to repeal and replace certain aspects of the ACA.
In addition, other legislative changes have been proposed and adopted since the ACA was enacted. These changes include the
Budget Control Act of 2011, which resulted in reductions to Medicare payments to providers of 2% per fiscal year, which went into
effect on April 1, 2013 and will stay in effect through 2025 unless additional Congressional action is taken, as well as, the American
Taxpayer Relief Act of 2012, which, among other things, further reduced Medicare payments to several types of providers, including
hospitals and imaging centers, and increased the statute of limitations period for the government to recover overpayments to providers
from three to five years. An expansion in government’s role in the U.S. healthcare industry may lower reimbursements for procedures
using our products, reduce medical procedure volumes, and adversely affect our business and results of operations, possibly
materially.
We believe that the overall escalating cost of medical products and services has led to, and will continue to lead to, increased
pressures on the healthcare industry to reduce the costs of products and services. We cannot assure you that government or private
third-party payors will cover and provide adequate payment for the procedures using our products. In addition, it is possible that future
legislation, regulation, or reimbursement policies of third-party payors will adversely affect the demand for procedures using our
products or our ability to sell our products on a profitable basis. The unavailability or inadequacy of third-party payor coverage or
reimbursement could have a significant adverse effect on our business, operating results and financial condition.
Employees
As of December 31, 2016, we had 162 employees in the U.S., approximately 140 of which were based in our Carlsbad,
California headquarters, covering all of the following functional areas: sales, customer service, marketing, clinical education,
advanced manufacturing, quality assurance, regulatory affairs, research and development, human resources, finance, legal, information
technology and administration. We have never experienced a work stoppage due to labor difficulties and believe that our relations
with our employees are good. We currently have no employees working under collective bargaining agreements. On February 1,
2017, we implemented a workforce reduction, aimed at further aligning our employee count and operating expense with our current
revenues. As of March 21, 2017, we have 142 employees, all located within the U.S., of which 119 are based in our Carlsbad,
California headquarters.
Corporate and Available Information
We are a Delaware corporation. We were incorporated in March 2005. Our principal executive office is located at 5818 El
Camino Real, Carlsbad, California 92008. Our Internet address is www.alphatecspine.com. We are not including the information
contained on our website as a part of, or incorporating it by reference into, this Annual Report on Form 10-K. Our annual reports on
Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and all amendments to those reports, are available to you
free of charge through the Investor Relations section of our website as soon as reasonably practicable after such materials have been
electronically filed with, or furnished to, the Securities and Exchange Commission, or SEC.
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Item 1A.
Risk Factors
Investing in our common stock involves a high degree of risk. You should carefully consider the following risk factors and all
other information contained or incorporated by reference in this Annual Report on Form 10-K. The risks and uncertainties described
below are not the only ones facing us. Additional risks and uncertainties that we are unaware of, or that we currently deem
immaterial, also may become important factors that affect us. If any of such risks or the risks described below, either alone or taken
together, occur, our business, financial condition or results of operations could be materially and adversely affected. In that case, the
trading price of our common stock could decline, and you may lose some or all of your investment.
Risks Related to Our Business and Industry
Our business plan relies on certain assumptions pertaining to the market for our products that, if incorrect, may adversely affect
our growth and profitability.
We allocate our design, development, marketing, management and financial resources based on our business plan, which
includes assumptions about various demographic trends and trends in the treatment of spine disorders and the resulting demand for our
products. However, these trends are uncertain. There can be no assurance that our assumptions with respect to an aging population
with broad medical coverage and longer life expectancy, which we expect to lead to increased spinal injuries and degeneration, are
accurate. In addition, an increasing awareness and use of non-invasive means for the prevention and treatment of back pain and
rehabilitation purposes may reduce demand for, or slow the growth of sales of, spine fusion products. A significant shift in
technologies or methods used in the treatment of back pain or damaged or diseased bone and tissue could adversely affect demand for
some or all of our products. For example, pharmaceutical advances could result in non-surgical treatments gaining more widespread
acceptance as a viable alternative to spine fusion. The emergence of new biological or synthetic materials to facilitate regeneration of
damaged or diseased bone and to repair damaged tissue could increasingly minimize or delay the need for spine fusion surgery and
provide other biological alternatives to spine fusion. New surgical procedures could diminish demand for some of our products. The
increased acceptance of emerging technologies that do not require spine fusion, such as artificial discs and nucleus replacement, for
the surgical treatment of spine disorders would reduce demand for, or slow the growth of sales of, spine fusion products. If our
assumptions regarding these factors prove to be incorrect or if alternative treatments to those offered by our products gain further
acceptance, then demand for our products could be significantly less than we anticipate and we may not be able to achieve or sustain
growth or profitability.
We are in a highly competitive market segment, face competition from large, well-established medical device companies with
significant resources, and may not be able to compete effectively.
The market for spine fusion products and procedures is intensely competitive, subject to rapid technological change and
significantly affected by new product introductions and other market activities of industry participants. In 2016, a significant
percentage of global spine implant product revenues was generated by Medtronic Sofamor Danek, a subsidiary of Medtronic, Inc.;
Depuy Spine, a subsidiary of Johnson & Johnson; and Stryker Spine. Our competitors also include numerous other publicly-traded and
privately-held companies such as NuVasive, Zimmer, Biomet, Globus, K2M Medical and SeaSpine.
Several of our competitors enjoy competitive advantages over us, including:
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more established relationships with spine surgeons;
more established distribution networks;
broader spine surgery product offerings;
stronger intellectual property portfolios;
greater financial and other resources for product research and development, sales and marketing, and patent litigation;
greater experience in, and resources for, launching, marketing, distributing and selling products;
significantly greater name recognition as well as more recognizable trademarks for products similar to the products that
we sell;
more established relationships with healthcare providers and payors;
products supported by more extensive clinical data; and
greater experience in obtaining and maintaining FDA and other regulatory clearances or approvals for products and
product enhancements.
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In addition, at any time our current competitors or other companies may develop alternative treatments, products or procedures
for the treatment of spine disorders that compete directly or indirectly with our products, including ones that prove to be superior to
our spine surgery products. For these reasons, we may not be able to compete successfully against our existing or potential
competitors. Any such failure could lead us to modify our strategy, lower our prices, increase the commissions we pay on sales of our
products and have a significant adverse effect on our business, financial condition and results of operations.
The sale of our international distribution operations and agreements will reduce our revenue, and we may not be successful in
executing on our business strategy to solely focus on the U.S. marketplace.
Prior to the sale of our International operations in September 2016, our international revenue represented approximately 35% of
our total revenue for the six months ended June 30, 2016 and year ended December 31, 2015. Following the closing of the Globus
Transaction, our revenues have been and will continue to be materially reduced as we will no longer be generating the same level of
revenue from the operations and assets sold in the transaction. There can be no assurance that the proceeds from the Globus
Transaction will be sufficient for us to grow our U.S. business. In addition, our future growth will depend on our ability to
successfully implement our strategy to focus solely on the U.S. marketplace. If we are unable to successfully execute on this business
strategy or otherwise compete effectively within the U.S. marketplace, our business, financial condition, results of operations and
growth prospects would be materially and adversely affected.
We may face indemnity and other liability claims pursuant to the Globus Purchase and Sale Agreement.
Under the purchase and sale agreement for the Globus Transaction, we will indemnify Globus against damages arising from,
among other things, breaches of our representations, warranties or obligations under the agreement and liabilities not assumed by
Globus. The indemnification period generally runs for a period of 18 months from the Closing, with longer survival periods for certain
specified representations and warranties. Our indemnification obligations are subject to a deductible in certain cases of $500,000, and
our aggregate liability under such indemnification claims is generally limited to $12.0 million, $20.0 million for certain specified
representations and warranties, and the full purchase price for breaches of certain specified representations and warranties, breaches of
covenants and certain other matters. If Globus makes an indemnification claim, we may incur liability and/or expenses, which could
harm our operating results. In addition, such indemnity claims may divert management attention from our continuing business.
A significant percentage of our revenues are derived from the sale of our systems that include polyaxial pedicle screws.
Net sales of our systems that include polyaxial pedicle screws represented approximately 50% of our net sales for 2016 and
2015. A decline in sales of these systems, due to lower market demand, the introduction by a third party of a competitive product, an
intellectual property dispute involving these systems, or otherwise, would have a significant adverse impact on our business, financial
condition and results of operations. Some of the technology related to our polyaxial pedicle screw systems is licensed to us. Any
action that would prevent us from manufacturing, marketing and selling our polyaxial pedicle screw systems would have a significant
adverse effect on our business, financial condition and results of operations.
Our sales and marketing efforts are largely dependent upon third parties, many of which are free to market products that compete
with our products.
Many of our independent distributors also market and sell the products of our competitors, and those competitors may have the
ability to influence the products that our independent distributors choose to market and sell. Our competitors may be able, by offering
higher commission payments or otherwise, to convince our independent distributors to terminate their relationships with us, carry
fewer of our products or reduce their sales and marketing efforts for our products.
If pricing pressures cause us to decrease prices for our goods and services and we are unable to compensate for such reductions
through changes in our product mix or reductions to our expenses, our results of operations will suffer.
We have experienced and may continue to experience decreasing prices for our goods and services we offer due to pricing
pressure exerted by our customers in response to increased cost containment efforts from managed care organizations and other third-
party payors and increased market power of our customers as the medical device industry consolidates. If we are unable to offset such
price reductions through changes in our product mix or reductions in our expenses, our business, financial condition, results of
operations and cash flows will be adversely affected.
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To be commercially successful, we must convince the spine surgeon community that our products are an attractive alternative to
our competitors’ products. If the spine surgeon community does not use our products, our sales will decline and we will be unable
to increase our sales and profits.
In order for us to sell our products, surgeons must be convinced that our products are superior to competing products.
Acceptance of our products depends on educating the spine surgeon community as to the distinctive characteristics, perceived
benefits, safety and cost-effectiveness of our products compared to our competitors’ products and on training surgeons in the proper
application of our products. If we are not successful in convincing the spine surgeon community of the merit of our products, our sales
will decline and we will be unable to increase or achieve and sustain growth or profitability.
There is a learning process involved for spine surgeons to become proficient in the use of our products. Although most spine
surgeons may have adequate knowledge on how to use most of our products based on their clinical training and experience, we believe
that the most effective way to introduce and build market demand for our products is by directly training spine surgeons in the use of
our products. If surgeons are not properly trained, they may misuse or ineffectively use our products. This may also result in
unsatisfactory patient outcomes, patient injury, negative publicity or lawsuits against us, any of which could have a significant adverse
effect on our business, financial condition and results of operations.
We must retain the current distributors of our products and attract new distributors of our products.
We plan to increase our network of independent distributors. The establishment and development of a broader distribution
network may be expensive and time consuming. Because of the intense competition for their services, we may be unable to recruit or
retain additional qualified independent distributors. Often, our competitors enter into distribution agreements with independent
distributors that require such distributors to exclusively sell the products of our competitors. Further, we may not be able to enter into
agreements with independent distributors on commercially reasonable terms, if at all. Even if we do enter into agreements with
additional independent distributors, it often takes 90 to 120 days for new distributors to reach full operational effectiveness and such
distributors may not generate revenue as quickly as we expect them to, commit the necessary resources to effectively market and sell
our products or ultimately be successful in selling our products. Our business, financial condition and results of operations will be
materially adversely affected if we do not retain our existing independent distributors and attract new, additional independent
distributors or if the marketing and sales efforts of our independent distributors and our own direct sales representatives are
unsuccessful.
We rely on a limited number of third parties to manufacture and supply our products. Any problems experienced by any of these
manufacturers could result in a delay or interruption in the supply of our products to us until such manufacturer cures the
problem or until we locate and qualify an alternative source of supply.
We rely on third party suppliers for the manufacture of our implants and instruments. We currently rely on a limited number of
third party suppliers and any prolonged disruption in the operations of our third party suppliers could have a significant negative
impact on our ability to supply our products to customers and to perform our obligations under the Supply Agreement with Globus,
and would cause us to seek additional third-party manufacturing contracts, which may not be available on acceptable terms, if at all.
We may suffer losses as a result of business interruptions that exceed coverage under our manufacturer’s insurance policies. Events
beyond our control, such as natural disasters, fire, sabotage or business accidents could have a significant negative impact on our
operations by disrupting our product development and commercialization efforts until such third-party supplier can repair its facility
or put in place third-party contract manufacturers to assume this manufacturing role, which we may not be able to do on reasonable
terms, if at all. In addition, if we are required to change manufacturers for any reason, we will be required to verify that the new
manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines.
The delays associated with the verification of a new manufacturer or the re-verification of an existing manufacturer could negatively
affect our ability to develop products or supply products to customers in a timely manner. Any disruption in the manufacture of our
products by our third party suppliers could have a material adverse impact on our business, financial condition and results of
operations.
We depend on various third-party suppliers, and in one case a single third-party supplier, for key raw materials used in the
manufacturing processes for our products and the loss of any of these third-party suppliers, or their inability to supply us with
adequate raw materials, could harm our business.
We use a number of raw materials, including titanium, titanium alloys, stainless steel, PEEK, and human tissue. We rely from
time to time on a number of suppliers and in one case on a single source vendor, Invibio. We have a supply agreement with Invibio,
pursuant to which it supplies us with PEEK, a biocompatible plastic that we use in some of our spacers. Invibio is one of a limited
number of companies approved to distribute PEEK in the U.S. for use in implantable devices. During 2016 and 2015, approximately
20% of our revenues were derived from products manufactured using PEEK.
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We depend on a limited number of sources of human tissue for use in our biologics products, and any failure to obtain tissue
from these sources or to have the tissue processed by these entities for us in a timely manner will interfere with our ability to meet
demand for our biologics products effectively. The processing of human tissue into biologics products is labor intensive and it is
therefore difficult to maintain a steady supply stream. In addition, due to seasonal changes in mortality rates, some scarce tissues used
for our biologics products are at times in particularly short supply. We cannot be certain that our supply of human tissue from our
current suppliers and our current inventory of biologics products will be available at current levels or will be sufficient to meet our
needs.
Our dependence on a single third-party PEEK supplier and the challenges we may face in obtaining adequate supplies of
biologics products involve several risks, including limited control over pricing, availability, quality and delivery schedules. In
addition, any supply interruption in a limited or sole sourced component or raw material, such as PEEK or human tissue, could
materially harm the ability of our third party manufacturers to manufacture our products until a new source of supply, if any, could be
found. We may be unable to find a sufficient alternative supply channel in a reasonable time period or on commercially reasonable
terms, if at all, which would have a significant adverse effect on our business, financial condition and results of operations.
Our tissue-based products and related technologies could become subject to significantly greater regulation by the FDA, which
could disrupt our business.
The FDA regulates human cells, tissues, and cellular and tissue-based products or HCT/Ps, but the extent to which they are
regulated depends on how they are manufactured and used and whether they meet other criteria for minimal regulation. These criteria
include but are not limited to the use of the HCT/Ps for homologous use only and minimal manipulation of the HCT/Ps. These
HCT/Ps are regulated by the FDA solely under Section 361 of the Public Health Service Act and are referred to as “Section 361
HCT/Ps,” while other HCT/Ps are subject to FDA’s regulatory requirements applicable to medical devices or biologics. Section 361
HCT/Ps do not require 510(k) clearance, PMA approval, licensure of a biologics license application, or BLA, or other premarket
authorization from FDA before marketing. We believe our HCT/Ps are regulated solely under Section 361 of the PHSA, and therefore,
we have not sought or obtained 510(k) clearance, PMA approval, or licensure through a BLA. The FDA could disagree with our
determination that our tissue-based products are Section 361 HCT/Ps and could determine that these products are biologics requiring a
BLA or medical devices requiring 510(k) clearance or PMA approval, and could require that we cease marketing such products and/or
recall them pending appropriate clearance, approval or license from the FDA. If the FDA determines that any of our current or future
products contain HCT/Ps that do not meet the criteria for regulation as a Section 361 HCT/P, it could subject some of our products to
additional review and regulatory oversight. If this were to happen, further distribution of the affected products could be interrupted for
a substantial period of time, which would reduce our revenues and hurt our profitability.
If we or our suppliers fail to comply with the FDA’s quality system and good tissue practice regulations, the manufacture of our
products could be delayed.
We and our suppliers are required to comply with the FDA’s QSR, which covers, among other things, the methods and
documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, record keeping, storage
and shipping of our products. In addition, suppliers and processors of products derived from HCT must comply with the FDA’s
current good tissue practice requirements, or cGTPs, which govern the methods used in and the facilities and controls used for the
manufacture of HCT/Ps, record keeping and the establishment of a quality program. The FDA audits compliance with the QSR and
cGTPs through inspections of manufacturing and other facilities. If we or our suppliers have significant non-compliance issues or if
any corrective action plan is not sufficient, we or our suppliers could be forced to halt the manufacture of our products until such
problems are corrected to the FDA’s satisfaction, which could have a material adverse effect on our business, financial condition and
results of operations. Further, our products could be subject to recall if the FDA determines, for any reason, that our products are not
safe or effective. Any recall or FDA requirement demanding that we seek additional approvals or clearances could result in delays,
costs associated with modification of a product, loss of revenue and potential operating restrictions imposed by the FDA, all of which
could have a material adverse effect on our business, financial condition and results of operations.
On July 17, 2015, Alphatec Spine, Inc., our wholly owned subsidiary, received a Warning Letter from the FDA in connection
with the FDA’s inspection of our manufacturing facilities located in Carlsbad, California that occurred from February 4, 2015 until
March 13, 2015, or the Inspection. In the Warning Letter, the FDA cited eight deficiencies in our responses to investigator's
observations on the FDA Form 483, which was issued to us at the end of the Inspection. The deficiencies relate to our internal
procedures for quality planning, design control, document control and corrective and preventive actions. The Warning Letter does not
restrict production or shipment of our products from our facilities, or the sale or marketing of our products. On November 16, 2015,
we responded to the FDA regarding the deficiencies set forth in the Warning Letter. We believe we have effectively addressed the
FDA concerns in the Warning Letter, but are awaiting an inspection or other response from the FDA to validate our resolution of such
deficiencies. Until the resolution of the deficiencies set forth in the Warning Letter are validated by the FDA, we may be subject to
additional regulatory action by the FDA, and any such actions could significantly disrupt our ongoing business and operations and
have a material adverse impact on our financial position and operating results. There can be no assurance that the FDA will be
satisfied with our response or proposed resolutions.
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Healthcare policy changes, including recent federal legislation to reform the U.S. healthcare system, 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 payors to control these costs and, more generally, to reform the U.S.
healthcare 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, limit the acceptance and availability of our products, and have a material adverse effect on
our financial position and results of operations. An expansion in government’s role in the U.S. healthcare industry may lower
reimbursements for procedures using our products, reduce medical procedure volumes and adversely affect our business and results of
operations, possibly materially.
The demand for products and the prices at which customers and patients are willing to pay for our products depend upon the
ability of our customers to obtain adequate third-party coverage and reimbursement for their purchases of our products.
Sales of our products depend in part on the availability of adequate coverage and reimbursement from governmental and private
payors. In the U.S., healthcare providers that purchase our products generally rely on third-party payors, principally Medicare,
Medicaid and private health insurance plans, to pay for all or a portion of the costs and fees associated with the use of our products. In
addition, several million individuals were able to purchase health insurance in 2014 for the first time through health insurance
"exchanges" established under the ACA. While procedures using our currently marketed products are eligible for reimbursement in
the U.S., if surgical procedures utilizing our products are performed on an outpatient basis, it is possible that private payors may no
longer provide reimbursement for the procedures using our products without further supporting data on the procedure. Any delays in
obtaining, or an inability to obtain, adequate coverage or reimbursement for procedures using our products could significantly affect
the acceptance of our products and have a significant adverse effect on our business. Additionally, third-party payors continue to
review their coverage policies carefully for existing and new therapies and can, without notice, deny coverage for treatments that
include the use of our products. Our business would be negatively impacted if there are any changes that reduce reimbursement for our
products.
Furthermore, healthcare costs have risen significantly over the past decade. There have been and may continue to be proposals
by legislators, regulators and third-party payors to contain these costs. Several such proposals were enacted as part of ACA, and
include numerous provisions to limit Medicare spending through reductions in various fee schedule payments and sweeping payment
reforms. Other federal and state cost-control measures include prospective payment systems, capitated rates, group purchasing,
redesign of benefits, requiring pre-authorizations or second opinions prior to major surgery, encouragement of healthier lifestyles and
exploration of more cost-effective methods of delivering healthcare. Some healthcare providers in the U.S. have adopted or are
considering a managed care system in which the providers contract to provide comprehensive healthcare for a fixed cost per person.
Healthcare providers may also attempt to control costs by authorizing fewer elective surgical procedures or by requiring the use of the
least expensive devices possible. These cost-control methods also potentially limit the amount which healthcare providers may be
willing to pay for medical devices. In addition, in the U.S., no uniform policy of coverage and reimbursement for medical technology
exists among all these payors. Therefore, coverage of and reimbursement for medical technology can differ significantly from payor to
payor. The continuing efforts of third-party payors, whether governmental or commercial, whether inside or outside the U.S., to
contain or reduce these costs, combined with closer scrutiny of such costs, could restrict our customers’ ability to obtain adequate
coverage and reimbursement from these third-party payors. The cost containment measures contained in ACA and other measures
being considered at the federal and state level, as well as internationally, could harm our business by adversely affecting the demand
for our products or the price at which we can sell our products.
Consolidation in the healthcare industry could lead to demands for price concessions or to the exclusion of some suppliers from
certain of our markets, which could have an adverse effect on our business, financial condition or results of operations.
Because healthcare costs have risen significantly over the past decade, numerous initiatives and reforms initiated by legislators,
regulators and third-party payors to curb these costs have resulted in a consolidation trend in the healthcare industry to create new
companies with greater market power, including hospitals. As the healthcare industry consolidates, competition to provide products
and services to industry participants has become and will continue to become more intense. This in turn has resulted and will likely
continue to result in greater pricing pressures and the exclusion of certain suppliers from important market segments as group
purchasing organizations, independent delivery networks and large single accounts continue to use their market power to consolidate
purchasing decisions for some of our customers. We expect that market demand, government regulation, third-party reimbursement
policies and societal pressures will continue to change the worldwide healthcare industry, resulting in further business consolidations
and alliances among our customers, which may reduce competition, exert further downward pressure on the prices of our products and
may adversely impact our business, financial condition or results of operations.
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We may be subject to or otherwise affected by federal and state healthcare laws, including fraud and abuse, health information
privacy and security, and disclosure laws, and could face substantial penalties if we are unable to fully comply with such laws.
Although we do not provide healthcare services, submit claims for third-party reimbursement, or receive payments directly from
Medicare, Medicaid, or other third-party payors for our products or the procedures in which our products are used, healthcare
regulation by federal and state governments significantly impacts our business. Healthcare fraud and abuse, health information privacy
and security, and disclosure laws potentially applicable to our operations include:
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the federal Anti-Kickback Statute, as well as state analogs, which constrains our marketing practices and those of our
independent sales agents and distributors, educational programs, pricing policies, and relationships with healthcare
providers by prohibiting, among other things, knowingly and willfully soliciting, receiving, offering or providing
remuneration, intended to induce the purchase or recommendation of an item or service reimbursable under a federal (or
state or commercial) healthcare program (such as the Medicare or Medicaid programs);
the federal ban, as well as state analogs, on physician self-referrals, which prohibits, subject to certain exceptions,
physician referrals of Medicare and Medicaid patients to an entity providing certain “designated health services” if the
physician or an immediate family member of the physician has any financial relationship with the entity;
federal false claims laws which prohibit, among other things, knowingly presenting, or causing to be presented, claims for
payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;
HIPAA, and its implementing regulations, which created federal criminal laws that prohibit executing a scheme to defraud
any healthcare benefit program or making false statements relating to healthcare matters;
the state and federal laws “sunshine” provisions that require detailed reporting and disclosures to CMS and applicable
states of any payments or “transfer of value” made or distributed to prescribers and other health care providers, and for
certain states prohibit some forms of these payments, require the adoption of marketing codes of conduct, require the
reporting of marketing expenditures and pricing information and constrain relationships with physicians and other referral
sources;
state laws analogous to each of the above federal laws, such as anti-kickback and false claims laws that may apply to
items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the
privacy of certain health information, many of which differ from each other in significant ways and often are not
preempted by HIPAA, thus complicating compliance efforts;
the Administrative Simplification provisions of HIPAA, specifically, privacy and security provisions including recent
amendments under HITECH which impose stringent restrictions on uses and disclosures of protected health information such as
for marketing or clinical research purposes and impose significant civil and criminal penalties for non-compliance and require
the reporting of breaches to affected individuals, the government and in some cases the media in the event of a violation; and
a variety of state-imposed privacy and data security laws which require the protection of information beyond health
information, such as employee information or any class of information combining name with state issued identification
numbers, social security numbers, credit card, bank or other financial information and which require reporting to state
officials in the event of breach or violation and which impose both civil and criminal penalties.
ACA includes various provisions designed to strengthen significantly fraud and abuse enforcement, such as increased funding
for enforcement efforts and the lowering of the intent requirement of the federal Anti-Kickback Statute and criminal healthcare fraud
statute such that a person or entity no longer needs to have actual knowledge of these statutes or specific intent to violate them.
If our past or present operations, or those of our independent sales agents and distributors are found to be in violation of any of
such laws or any other governmental regulations that may apply to us, we may be subject to penalties, including civil and criminal
penalties, damages, fines, exclusion from federal healthcare programs and/or the curtailment or restructuring of our operations.
Similarly, if the healthcare providers, sales agents, distributors or other entities with which we do business are found to be non-
compliant with applicable laws, they may be subject to sanctions, which could also have a negative impact on us. Any penalties,
damages, fines, curtailment or restructuring of our operations could adversely affect our ability to operate our business and our
financial results. The risk of our being found in violation of these laws is increased by the fact that many of them have not been fully
interpreted by the regulatory authorities or the Courts, and their provisions are open to a variety of interpretations. Any action against
us for violation of these laws, even if we successfully defend against them, could cause us to incur significant legal expenses and
divert our management’s attention from the operation of our business.
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The sales and marketing practices of our industry have been the subject of increased scrutiny from federal and state government
agencies, and we believe that this trend will continue. For example, on March 26, 2013 the OIG issued a Special Fraud Alert entitled
"Physician-Owned Entities" related to physician-owned distributors, or PODS. Since 2013, the OIG has further increased its scrutiny
of PODs and the Department of Justice has brought several high profile cases against physician owners. Prosecutorial scrutiny and
governmental oversight over some major device companies regarding the retention of healthcare professionals as consultants has
affected and may continue to affect the manner in which medical device companies may retain healthcare professionals as consultants.
Any precautions we take to detect and prevent noncompliance with applicable laws may not be effective in controlling unknown or
unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to
comply with these laws or regulations. Any action against us for violation of these laws, even if we successfully defend against them,
could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.
If we fail to obtain, or experience significant delays in obtaining, FDA clearances or approvals for our future products or
modifications to our products, our ability to commercially distribute and market our products could suffer.
Our medical devices are subject to extensive regulation by the FDA and numerous other federal, state and foreign governmental
authorities. The process of obtaining regulatory clearances or approvals to market a medical device, particularly from the FDA, can be
costly and time consuming, and there can be no assurance that such clearances or approvals will be granted on a timely basis, if at all.
In particular, the FDA permits commercial distribution of most new medical devices only after the devices have received clearance
under Section 510(k) of the Federal Food, Drug and Cosmetic Act, or 510(k), or are the subject of an approved premarket approval
application, or a PMA. The 510(k) process generally takes three to nine months, but can take significantly longer, especially if the
FDA requires a clinical trial to support the 510(k) application. Currently, we do not know whether the FDA will require clinical data
in support of any 510(k)s that we intend to submit for other products in our pipeline. In addition, the FDA continues to re-examine its
510(k) clearance process for medical devices and published several draft guidance documents that could change that process. Any
changes that make the process more restrictive could increase the time it takes for us to obtain clearances or could make the 510(k)
process unavailable for certain of our products. A PMA must be submitted to the FDA if the device cannot be cleared through the
510(k) process or is not exempt from premarket review by the FDA. A PMA must be supported by extensive data, including results of
preclinical studies and clinical trials, manufacturing and control data and proposed labeling, to demonstrate to the FDA’s satisfaction
the safety and effectiveness of the device for its intended use. The PMA process is more costly and uncertain than the 510(k) clearance
process, and generally takes between one and three years, if not longer. In addition, any modification to a 510(k)-cleared device that
could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design or manufacture,
requires a new 510(k) clearance or, possibly, a PMA.
Modifications to products that are approved through a PMA application generally need FDA approval. Similarly, some
modifications made to products cleared through a 510(k) may require a new 510(k). Our commercial distribution and marketing of
any products or product modifications that we develop will be delayed until regulatory clearance or approval is obtained. In addition,
because we cannot assure you that any new products or any product modifications we develop will be subject to the shorter 510(k)
clearance process, the regulatory approval process for our new products or product modifications may take significantly longer than
anticipated. There is no assurance that the FDA will not require a new product or product modification to go through the lengthy and
expensive PMA approval process. The FDA can delay, limit or deny clearance or approval of a device for many reasons, including:
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our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or notified body that our
products are safe or effective for their intended uses;
the disagreement of the FDA or the applicable foreign regulatory body with the design or implementation of our clinical
trials or the interpretation of data from pre-clinical studies or clinical trials;
serious and unexpected adverse device effects experienced by participants in our clinical trials;
the data from our pre-clinical studies and clinical trials may be insufficient to support clearance or approval, where
required;
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our inability to demonstrate that the clinical and other benefits of the device outweigh the risks;
the manufacturing process or facilities we use may not meet applicable requirements; or
the potential for approval policies or regulations of the FDA or applicable foreign regulatory bodies to change
significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval.
Delays in obtaining regulatory clearances and approvals may:
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delay or prevent commercialization of products we develop;
require us to perform costly tests or studies;
diminish any competitive advantages that we might otherwise have obtained; and
reduce our ability to collect revenues.
To date, all of our non-biologic medical device products that have required FDA review that are being sold in the U.S. have
been cleared through the 510(k) process without any required clinical trials. However, the FDA may require clinical data in support of
any future 510(k)s or PMAs that we intend to submit for products in our pipeline. We have limited experience in performing clinical
trials that might be required for a 510(k) clearance or PMA approval. If any of our products require clinical trials, the
commercialization of such products could be delayed which could have a material adverse effect on our business, financial condition
and results of operations.
The safety of our products is not yet supported by long-term clinical data and may therefore prove to be less safe and effective than
initially thought.
We obtained clearance to offer all of our current non-biologic medical device products through the 510(k) route. The ability to
obtain a 510(k) clearance is generally based on the FDA’s agreement that a new product is substantially equivalent to certain already
marketed products. Because most 510(k)-cleared products were not the subject of pre-market clinical trials, surgeons may be slow to
adopt our 510(k)-cleared products, we may not have the comparative data that our competitors have or are generating, and we may be
subject to greater regulatory and product liability risks. With the passage of the American Recovery and Reinvestment Act of 2009,
funds have been appropriated for the U.S. Department of Health and Human Services’ Healthcare Research and Quality to conduct
comparative effectiveness research to determine the effectiveness of different drugs, medical devices, and procedures in treating
certain conditions and diseases. Some of our products or procedures performed with our products could become the subject of such
research. It is unknown what effect, if any, this research may have on our business. Further, future research or experience may indicate
that treatment with our products does not improve patient outcomes or improves patient outcomes less than we initially expect. Such
results would reduce demand for our products and this could cause us to withdraw our products from the market. Moreover, if future
research or experience indicate that our products cause unexpected or serious complications or other unforeseen negative effects, we
could be subject to significant legal liability, significant negative publicity, damage to our reputation and a dramatic reduction in sales
of our products, all of which would have a material adverse effect on our business, financial condition and results of operations.
Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial
penalties, and might require us to recall or withdraw a product from the market.
Once a medical device is cleared or approved, a manufacturer must notify the FDA of any modifications to the device. Any
modification to a device that has received FDA clearance that could significantly affect its safety or effectiveness, or that would
constitute a major change in its intended use, design or manufacture, requires premarket clearance or possibly approval of a PMA. The
FDA requires every manufacturer to make the determination in the first instance regarding whether a modification to a cleared or
approved device necessitates the filing of a new 510(k) notification or PMA supplement. The FDA may review any manufacturer's
decision and can disagree. If the FDA disagrees with any future determination by us that a new clearance or approval is not required,
we may need to cease marketing or to recall the modified product until and unless we obtain clearance or approval. In addition, we
could also be subject to significant regulatory fines or penalties. Any of these outcomes would harm our business.
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The regulations to which we are subject are complex and have become more stringent over time. Regulatory changes could
result in restrictions on our ability to continue or expand our operations, higher than anticipated costs, or lower than anticipated sales.
Even after we have obtained the proper regulatory clearance or approval to market a product, we have ongoing responsibilities under
FDA regulations and applicable foreign laws and regulations. The FDA’s and other regulatory authorities’ policies may change and
additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. For
example, in December 2016, the 21st Century Cures Act, or Cures Act, was signed into law. The Cures Act, among other things, is
intended to modernize the regulation of devices and spur innovation, but its ultimate implementation is unclear. The FDA, state and
foreign regulatory authorities have broad enforcement powers. If we are slow or unable to adapt to changes in existing requirements or
the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to
enforcement action by the FDA, state or foreign regulatory authorities, which may include any of the following sanctions:
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untitled letters or warning letters;
fines, injunctions, consent decrees and civil penalties;
recalls, termination of distribution, administrative detention, or seizure of our products;
customer notifications or repair, replacement or refunds;
operating restrictions or partial suspension or total shutdown of production;
delays in or refusal to grant our requests for future 510(k) clearances, PMA approvals or foreign regulatory approvals of
new products, new intended uses, or modifications to existing products;
withdrawals or suspensions of current 510(k) clearances or PMAs or foreign regulatory approvals, resulting in
prohibitions on sales of our products;
FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; and/ or
criminal prosecution.
Any of these sanctions could result in higher than anticipated costs or lower than anticipated sales and have a material adverse
effect on our reputation, business, results of operations and financial condition.
We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or
administrative or executive action, either in the United States or abroad. For example, certain policies of the new Presidential
administration may impact our business and industry. Namely, the new Presidential administration has taken several executive
actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially
delay, FDA’s ability to engage in routine regulatory and oversight activities such as implementing statutes through rulemaking,
issuance of guidance, and review and approval of marketing applications. Notably, on January 23, 2017, the new Presidential
administration ordered a hiring freeze for all executive departments and agencies, including the FDA, which prohibits the FDA from
filling employee vacancies or creating new positions. Under the terms of the order, the freeze will remain in effect until
implementation of a plan to be recommended by the Director for the Office of Management and Budget, or OMB, in consultation with
the Director of the Office of Personnel Management, to reduce the size of the federal workforce through attrition. An under-staffed
FDA could result in delays in FDA’s responsiveness or in its ability to review submissions or applications, issue regulations or
guidance, or implement or enforce regulatory requirements in a timely fashion or at all. Moreover, on January 30, 2017, the new
Presidential administration issued an Executive Order, applicable to all executive agencies, including the FDA, that requires that for
each notice of proposed rulemaking or final regulation to be issued in fiscal year 2017, the agency shall identify at least two existing
regulations to be repealed, unless prohibited by law. These requirements are referred to as the “two-for-one” provisions. This
Executive Order includes a budget neutrality provision that requires the total incremental cost of all new regulations in the 2017 fiscal
year, including repealed regulations, to be no greater than zero, except in limited circumstances. For fiscal years 2018 and beyond, the
Executive Order requires agencies to identify regulations to offset any incremental cost of a new regulation and approximate the total
costs or savings associated with each new regulation or repealed regulation. In interim guidance issued by the Office of Information
and Regulatory Affairs within OMB on February 2, 2017, the administration indicates that the “two-for-one” provisions may apply not
only to agency regulations, but also to significant agency guidance documents. In addition, on February 24, 2017, the new
Presidential administration issued an executive order directing each affected agency to designate an agency official as a “Regulatory
Reform Officer” and establish a “Regulatory Reform Task Force” to implement the two-for-one provisions and other previously
issued executive orders relating to the review of federal regulations, however it is difficult to predict how these requirements will be
implemented, and the extent to which they will impact the FDA’s ability to exercise its regulatory authority. If these executive actions
impose constraints on FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be
negatively impacted.
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If we choose to acquire new and complementary businesses, products or technologies, we may be unable to complete these
acquisitions or successfully integrate them in a cost-effective and non-disruptive manner.
Our success depends in part on our ability to continually enhance and broaden our product offering in response to changing
customer demands, competitive pressures and technologies and our ability to increase our market share. Accordingly, we have pursued
and intend to pursue the acquisition of complementary businesses, products or technologies instead of developing them ourselves. We
do not know if we will be able to successfully complete any acquisitions, or whether we will be able to successfully integrate any
acquired business, product or technology into our business or retain any key personnel, suppliers or distributors. Our ability to
successfully grow through acquisitions depends upon our ability to identify, negotiate, complete and integrate suitable acquisitions and
to obtain any necessary financing. These efforts could be expensive and time consuming, disrupt our ongoing business and distract
management. If we are unable to integrate any future or recently acquired businesses, products or technologies effectively, our
business, financial condition and results of operations will be materially adversely affected. For example, an acquisition could
materially impair our operating results by causing us to incur debt or requiring us to amortize significant amounts of expenses,
including non-cash acquisition costs, and acquired assets.
We may not be able to timely develop new products or product enhancements that will be accepted by the market.
We sell our products in a market that is characterized by technological change, product innovation, evolving industry standards,
competing patent claims, patent litigation and intense competition. Our success will depend in part on our ability to develop and
introduce new products and enhancements or modifications to our existing products, which we will need to do before our competitors
do so and in a manner that does not infringe issued patents of third parties from which we do not have a license. We cannot assure you
that we will be able to successfully develop or market new, improved or modified products, or that any of our future products will be
accepted by even the surgeons who use our current products. Our competitors’ product development capabilities could be more
effective than our capabilities, and their new products may get to market before our products. In addition, the products of our
competitors may be more effective or less expensive than our products. The introduction of new products by our competitors may lead
us to have price reductions, reduced margins or loss of market share and may render our products obsolete or noncompetitive. The
success of any of our new product offerings or enhancement or modification to our existing products will depend on several factors,
including our ability to:
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properly identify and anticipate surgeon and patient needs;
develop new products or enhancements in a timely manner;
obtain the necessary regulatory approvals for new products or product enhancements;
provide adequate training to potential users of new products;
receive adequate reimbursement approval of third-party payors such as Medicaid, Medicare and private insurers; and
develop an effective marketing and distribution network.
Developing products in a timely manner can be difficult, in particular because product designs change rapidly to adjust to third-
party patent constraints and to market preferences. As a result, we may experience delays in our product launches which
may significantly impede our ability to enter or compete in a given market and may reduce the sales that we are able to generate from
these products. We may experience delays in any phase of a product launch, including during research and development, clinical
trials, manufacturing, marketing and the surgeon training process. In addition, our suppliers of products or components can suffer
similar delays, which could cause delays in our product introductions. If we do not develop new products or product enhancements in
time to meet market demand or if there is insufficient demand for these new products or enhancements, it could have a significant
adverse effect on our business financial condition and results of operations.
We are dependent on our senior management team, sales and marketing team, engineering team and key surgeon advisors, and
the loss of any of them could harm our business.
Our continued success depends in part upon the continued availability and contributions of our senior management, sales and
marketing team and engineering team and the continued participation of our key surgeon advisors. While we have entered into
employment agreements with all members of our senior management team, none of these agreements guarantees the services of the
individual for a specified period of time. We would be adversely affected if we fail to adequately prepare for future turnover of our
senior management team. Our ability to grow or at least maintain our sales levels depends in large part on our ability to attract and
retain sales and marketing personnel and for these sales people to maintain their relationships with surgeons directly and through our
distributors. We rely on our engineering team to research, design and develop potential products for our product pipeline. We also rely
on our surgeon advisors to advise us on our products, our product pipeline, long-term scientific planning, research and development
and industry trends. We compete for personnel and advisors with other companies and other organizations, many of which are larger
and have greater name recognition and financial and other resources than we do. We recently implemented numerous changes in our
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management team, including in the roles of Chief Executive Officer, Chief Financial Officer, Executive Vice President, People &
Culture, and General Counsel, which could have an adverse effect on our retention of our employees, advisors and distributors.
Changes to our senior management team, sales and marketing team, engineering team and key surgeon advisors, or our inability to
attract or retain other qualified personnel or advisors, could have a significant adverse effect on our business, financial conditions and
results of operations.
Compliance with laws and regulations and standards for accounting, corporate governance and public disclosure is time
consuming and results in significant expenses.
Changing laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley
Act of 2002, The Dodd-Frank Wall Street Reform and Consumer Protection Act, other SEC regulations, NASDAQ Stock Market
listing rules, and new accounting pronouncements create uncertainty and additional complexities for companies such as ours. Our
management and other personnel need to devote a substantial amount of time to these compliance initiatives. Moreover these rules
and regulations increase our legal and financial compliance costs and make some activities more time consuming and costly.
If we fail to maintain effective internal controls and procedures for financial reporting, we could be unable to provide timely and
accurate financial information and therefore be subject to delisting from The NASDAQ Global Select Market, an investigation by the
SEC, and civil or criminal sanctions. Additionally, ineffective internal control over financial reporting would place us at increased risk
of fraud or misuse of corporate assets and could cause our stockholders, lenders, suppliers and others to lose confidence in the
accuracy or completeness of our financial reports. This, in turn could adversely affect our ability to access the capital markets.
Security breaches, loss of data and other disruptions could compromise sensitive information related to our business, prevent us
from accessing critical information or expose us to liability, which could adversely affect our business and our reputation.
In the ordinary course of our business, we collect and store sensitive data, including legally protected patient health information,
credit card information, personally identifiable information about our employees, intellectual property, and proprietary business
information. We manage and maintain our applications and data utilizing on-site systems. These applications and data encompass a
wide variety of business critical information including research and development information, commercial information and business
and financial information.
The secure processing, storage, maintenance and transmission of this critical information is vital to our operations and business
strategy, and we devote significant resources to protecting such information. Although we take measures to protect sensitive
information from unauthorized access or disclosure, our information technology and infrastructure may be vulnerable to attacks by
hackers, viruses, breaches or interruptions due to employee error or malfeasance, terrorist attacks, earthquakes, fire, flood, other
natural disasters, power loss, computer systems failure, data network failure, Internet failure, or lapses in compliance with privacy and
security mandates. Any such attack, virus, breach or interruption could compromise our networks and the information stored there
could be accessed by unauthorized parties, publicly disclosed, lost or stolen. We have measures in place that are designed to detect and
respond to such security incidents and breaches of privacy and security mandates. Any such access, disclosure or other loss of
information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such as
HIPAA, government enforcement actions and regulatory penalties. Unauthorized access, loss or dissemination could also interrupt our
operations, including our ability to bill our customers, provide customer support services, conduct research and development activities,
process and prepare company financial information, manage various general and administrative aspects of our business and damage
our reputation, any of which could adversely affect our business.
Nearly all of our operations are currently conducted in locations that may be at risk of damage from fire, earthquakes or other
natural disasters.
We currently conduct nearly all of our development and management activities in Carlsbad, California near known wildfire
areas and earthquake fault zones. We have taken precautions to safeguard our facilities, including obtaining property and casualty
insurance, and implementing health and safety protocols. We have developed an information technology disaster recovery plan.
However, any future natural disaster, such as a fire or an earthquake, could cause substantial delays in our operations, damage or
destroy our equipment or inventory and cause us to incur additional expenses. A disaster could seriously harm our business, financial
condition and results of operations. Our facilities would be difficult to replace and would require substantial lead time to repair or
replace. The insurance we maintain against earthquakes, fires, and other natural disasters would not be adequate to cover a total loss of
our facilities, may not be adequate to cover our losses in any particular case and may not continue to be available to us on acceptable
terms, or at all.
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Alphatec Holdings is a holding company with no operations, and unless it receives dividends or other payments from its
subsidiaries, it will be unable to fulfill its cash obligations.
As a holding company with no business operations, Alphatec Holdings’ material assets consist only of the common stock of its
subsidiaries, including Alphatec Spine and Scient’x, dividends and other payments received from time to time from its subsidiaries,
and the proceeds raised from the sale of debt and equity securities. Alphatec Holdings’ subsidiaries are legally distinct from Alphatec
Holdings and have no obligation, contingent or otherwise, to make funds available to Alphatec Holdings. Alphatec Holdings will have
to rely upon dividends and other payments from its subsidiaries to generate the funds necessary to fulfill its cash obligations. Alphatec
Holdings may not be able to access cash generated by its subsidiaries in order to fulfill cash commitments. The ability of Alphatec
Spine to make dividend and other payments to Alphatec Holdings is subject to the availability of funds after taking into account its
subsidiaries’ funding requirements, the terms of its subsidiaries’ indebtedness and applicable state laws.
If we fail to properly manage our anticipated growth, our business could suffer.
We will continue to pursue growth in the number of surgeons using our products, the types of products we offer and the
geographic regions where our products are sold. Such anticipated growth has placed and will continue to place significant demands on
our managerial, operational and financial resources and systems. Future growth would impose significant added responsibilities on
members of management, including the need to identify, recruit, maintain, motivate and integrate additional personnel. Also, our
management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a
substantial amount of time to managing these anticipated growth activities. We are currently focused on increasing the size and
effectiveness of our sales force and distribution network, marketing activities, research and development efforts, inventory
management systems, management team and corporate infrastructure. If we do not manage our anticipated growth effectively, the
quality of our products, our relationships with physicians, distributors and hospitals, and our reputation could suffer, which would
have a significant adverse effect on our business, financial condition and results of operations. We must attract and retain qualified
personnel and third-party distributors and manage and train them effectively. Personnel qualified in the design, development,
production and marketing of our products are difficult to find and hire, and enhancements of information technology systems to
support our growth are difficult to implement. We will also need to carefully monitor and manage our surgeon services, our third-party
manufacturing resources, quality assurance and efficiency, and the quality assurance and efficiency of our suppliers and distributors.
This managing, training and monitoring will require allocation of valuable management resources and significant expense. If our
management is unable to effectively manage our expected growth, our expenses may increase more than expected, our ability to
generate and/or grow revenues could be reduced and we may not be able to implement our business strategy.
Our announced workforce reduction may cause undesirable consequences and our results of operations may be harmed.
Since September 2016, we have reduced our workforce by approximately 30%. This workforce reduction may yield unintended
consequences, such as attrition beyond our intended reduction in workforce and reduced employee morale, which may cause our
employees who were not affected by the reduction in workforce to seek alternate employment. Additional attrition could impede our
ability to meet our operational goals, which could have a material adverse effect on our financial performance. In addition, as a result
of the reductions in our workforce, we may face an increased risk of employment litigation. Furthermore, employees whose positions
will be eliminated in connection with these trends may seek future employment with our competitors. Although all our employees are
required to sign a confidentiality agreement with us at the time of hire, we cannot assure you that the confidential nature of our
proprietary information will be maintained in the course of such future employment. We cannot assure you that we will not undertake
additional reduction activities, that any of our efforts will be successful, or that we will be able to realize the cost savings and other
anticipated benefits from our previous or any future reduction plans. In addition, if we continue to reduce our workforce, it may
adversely impact our ability to respond rapidly to any new product, growth or revenue opportunities.
Risks Related to Our Financial Results, Credit and Certain Financial Obligations and Need for Financing
We may need to raise additional funds in the future and such funds may not be available on acceptable terms, if at all.
At December 31, 2016, our principal sources of liquidity consisted of cash of $19.6 million and accounts receivable, net of
$18.5 million. Together with the proceeds of our approximately $18.9 million private placement in March 2017, we currently
estimate this will provide sufficient capital to fund our operations through at least the next 12 months.
We may seek additional funds from public and private equity or debt financings, borrowings under new debt facilities or other
sources to fund our projected operating requirements. Our capital requirements will depend on many factors, including:
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the payments due in connection with the settlement of the Orthotec matter;
the revenues generated by sales of our products;
the costs associated with expanding our sales and marketing efforts;
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the expenses that we incur from the manufacture of our products by third parties and that we incur from selling our
products;
the costs of developing new products or technologies;
the cost of obtaining and maintaining FDA or other regulatory approval or clearance for our products and products in
development;
the cost of filing and prosecuting patent applications and defending and enforcing our patent and other intellectual
property rights;
the number and timing of acquisitions and other strategic transactions;
the costs and any payments we may make related to our pending litigation matters;
the costs associated with increased capital expenditures; and
the costs associated with our employee retention programs and related benefits.
As a result of these factors, we may need to raise additional funds and such funds may not be available on favorable terms, if at
all. However, under the securities purchase agreement we entered into in March 2017 in connection with our private placement of
common stock, Series A Convertible Preferred Stock and warrants to purchase common stock, or the March 2017 private placement,
we are prohibited from issuing or entering into any agreement to issue any shares of our common stock or other securities, subject to
certain permitted exceptions, until the later of (a) 90 days after the effective date of the resale registration statement we are required to
file registering the resale of the shares of common stock issued or issuable in the private placement or (b) the date of stockholder
approval of the March 2017 private placement. In addition, rules and regulations of the SEC may restrict our ability to conduct certain
types of financing activities, or may affect the timing of and the amounts we can raise by undertaking such activities. For example,
under current SEC regulations, at any time during which the aggregate market value of our common stock held by non-affiliates, or
our public float, is less than $75 million, the amount that we can raise through primary public offerings of securities in any twelve-
month period using one or more registration statements on Form S-3 will be limited to an aggregate of one-third of our public float. As
of March 29, 2017, our public float was $26 million.
In addition, upon the effectiveness of the resale registration statement we are required to file as part of the March 2017 private
placement, all of the 1,809,628 shares of common stock, 7,622,372 shares of common stock issuable upon the conversion of an
aggregate of approximately 15,245 shares of our Series A Convertible Preferred Stock and 9,432,000 shares of common stock issuable
upon exercise of warrants issued in the March 2017 private placement will become available for resale to the public, which will result
in dilution to our existing stockholders. In addition, if we fail to meet the specified filing deadlines for such resale registration
statement or maintain its effectiveness or do not comply with the current public information requirements to allow resales of the shares
pursuant to Rule 144 under the Securities Act, in each case subject to certain permitted exceptions, we may be required to pay
liquidated damages to the purchasers in the private placement, in amount of 1.5% of the original subscription amount per month,
subject to an aggregate maximum of 12% per calendar year in the case of the effectiveness of the resale registration statement.
Furthermore, if we issue additional equity or debt securities to raise additional funds, our existing stockholders may experience
dilution and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing stockholders.
In addition, if we raise additional funds through collaboration, licensing or other similar arrangements, it may be necessary to
relinquish valuable rights to our potential products or proprietary technologies, or to grant licenses on terms that are not favorable to
us. If we cannot raise funds on acceptable terms, we may not be able to repay debt or other liabilities, develop or enhance our
products, execute our business plan, take advantage of future opportunities, or respond to competitive pressures or unanticipated
customer requirements. Any of these events could adversely affect our ability to achieve our development and commercialization
goals and have a significant adverse effect on our business, financial condition and results of operations.
If we default on our obligations to make settlement payments to Orthotec LLC, the amounts due under the settlement agreements
accelerate and become due and payable.
Any default of our payment obligation under the settlement agreements we entered into with Orthotec LLC, or Orthotec, would
give Orthotec the right to declare all of the future payments to be immediately payable. As of March 17, 2017, the outstanding amount
to be paid to Orthotec through January 2024 is $30.4 million. If acceleration of payments occurs, our business, financial condition and
results of operations could be materially and adversely affected.
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We have a history of net losses, we expect to continue to incur net losses in the near future, and we may not achieve or maintain
profitability.
We have typically incurred net losses from our continuing operations since our inception. As of December 31, 2016, we had an
accumulated deficit of $457.2 million. We have incurred significant net losses since inception and have relied on our ability to fund
our operations through revenues from the sale of our products, equity financings and debt financings. As we have incurred losses,
successful transition to profitability is dependent upon achieving a level of revenues adequate to support our cost structure. This may
not occur and, unless and until it does, we will continue to need to raise additional capital. We may seek additional funds from public
and private equity or debt financings, borrowings under new debt facilities or other sources to fund our projected operating
requirements. However, there is no guarantee that we will be able to obtain further financing, or do so on reasonable terms. If we are
unable to raise additional funds on a timely basis, or at all, we would be materially adversely affected.
We may be unable to comply with the covenants of our credit facilities.
We must comply with certain affirmative and negative covenants, including financial covenants, in our Amended Credit Facility
and affirmative and negative covenants under the Globus Facility Agreement. We failed to comply with the fixed charge coverage
ratio for January and June 2016, the fixed charge coverage ratio, senior leverage ratio and total leverage ratio covenants for March
2016, and the fixed charge coverage ratio and total leverage ratio covenants for April and May 2016, under our Amended Credit
Facility. We also did not meet a minimum requirement for the percentage of our total cash held in U.S. accounts for January,
February, March, April, May and June 2016. MidCap and Deerfield, pursuant to the Deerfield Facility Agreement which has been
terminated, provided waivers with respect to our non-compliance during such periods. There can be no assurance that at all times in
the future we will satisfy all such financial or other covenants of the Amended Credit Facility or the Globus Facility Agreement, or
obtain any required waiver or amendment, in which event of default the lenders party to the Amended Credit Facility could refuse to
make further extensions of credit to us and MidCap and/or Globus could require all amounts borrowed under the Amended Credit
Facility and/or the Globus Facility Agreement, respectively, together with accrued interest and other fees, to be immediately due and
payable. In addition to allowing the lenders to accelerate the loan, several events of default under the Amended Credit Facility or
Globus Facility Agreement, such as our failure to make required payments of principal and interest and the occurrence of certain
bankruptcy or insolvency events, could require us to pay interest at a rate which is up to five percentage points higher than the interest
rate effective immediately before the event of default.
An event of default under the Amended Credit Facility or the Globus Facility Agreement could have a material adverse effect on
us. Upon an event of default, if the lenders under the Amended Credit Facility or Globus Facility Agreement accelerate the repayment
of all amounts borrowed, together with accrued interest and other fees, or if the lenders elect to charge us additional interest, we
cannot assure you that we will have sufficient cash available to repay the amounts due, and we may be forced to seek to amend the
terms of the Amended Credit Facility or the Globus Facility Agreement or obtain alternative financing, which may not be available to
us on acceptable terms, if at all.
In addition, if we fail to pay amounts when due under the Amended Credit Facility or the Globus Facility Agreement or upon
the occurrence of another event of default, the lenders under the Amended Credit Facility or the Globus Facility Agreement could
proceed against the collateral granted to them pursuant to the MidCap Amended Credit Facility and the Globus Facility Agreement.
We have granted to the lenders under the Amended Credit Facility a first priority security interest in substantially all of our assets,
including all accounts receivable and all securities evidencing our interests in our subsidiaries, as collateral under the Amended Credit
Facility. We have granted Globus under the Globus Facility Agreement a first lien security interest in substantially all of our assets,
other than accounts receivable and related assets, which will secure the Globus Facility Agreement on a second lien basis. If Globus
proceeds against the collateral, such assets would no longer be available for use in our business, which would have a significant
adverse effect our business, financial condition and results of operations.
Our quarterly financial results could fluctuate significantly.
Our quarterly financial results are difficult to predict and may fluctuate significantly from period to period, particularly because
our sales prospects are uncertain. The level of our revenues and results of operations at any given time will be based primarily on the
following factors:
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acceptance of our products by surgeons, patients, hospitals and third-party payors;
demand and pricing of our products;
the mix of our products sold, because profit margins differ among our products;
timing of new product offerings, acquisitions, licenses or other significant events by us or our competitors;
our ability to grow and maintain a productive sales and marketing organization and independent distributor network;
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regulatory approvals and legislative changes affecting the products we may offer or those of our competitors;
the effect of competing technological and market developments;
levels of third-party reimbursement for our products;
interruption in the manufacturing or distribution of our products;
our ability to produce or obtain products of satisfactory quality or in sufficient quantities to meet demand; and
changes in our ability to obtain FDA, state and international approval or clearance for our products.
In addition, until we have a larger base of surgeons using our products, occasional fluctuations in the use of our products by
individual surgeons or small groups of surgeons will have a proportionately larger impact on our revenues than for companies with a
larger customer base.
Many of the products we may seek to develop and introduce in the future will require FDA approval or clearance. We cannot
begin to commercialize any such products in the U.S. without FDA approval or clearance. As a result, it will be difficult for us to
forecast demand for these products with any degree of certainty. We cannot assure you that our revenue will increase or be sustained
in future periods or that we will be profitable in any future period. Any shortfalls in revenue or earnings from levels expected by our
stockholders or by securities or industry analysts could have an immediate and significant adverse effect on the trading price of our
common stock in any given period.
Risks Related to Our Intellectual Property Regulatory Penalties and Potential Litigation
If our patents and other intellectual property rights do not adequately protect our products, we may lose market share to our
competitors and be unable to operate our business profitably.
Our success depends significantly on our ability to protect our proprietary rights of the technologies used in our products. We
rely on patent protection, as well as a combination of copyright, trade secret and trademark laws, and nondisclosure, confidentiality
and other contractual restrictions to protect our proprietary technology. However, these legal means afford only limited protection and
may not adequately protect our rights or permit us to gain or keep any competitive advantage. For example, we cannot assure you that
any of our pending patent applications will result in the issuance of patents to us. The U.S. Patent and Trademark Office, or PTO,
may deny or require significant narrowing of claims in our pending patent applications, and patents issued as a result of the pending
patent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to
us. We could also incur substantial costs in proceedings before the PTO. These proceedings could result in adverse decisions as to the
priority of our inventions and the narrowing or invalidation of claims in issued patents. Our issued patents and those that may be
issued in the future could subsequently be successfully challenged by others and invalidated or rendered unenforceable, which could
limit our ability to stop competitors from marketing and selling related products. In addition, our pending patent applications include
claims to aspects of our products and procedures that are not currently protected by issued patents.
Both the patent application process and the process of managing patent disputes can be time consuming and expensive.
Competitors may be able to design around our patents or develop products that provide outcomes that are comparable to our products
but fall outside of the scope of our patent protection. Although we have entered into confidentiality agreements and intellectual
property assignment agreements with certain of our employees, consultants and advisors as one of the ways we seek to protect our
intellectual property and other proprietary technology, such agreements may not be enforceable or may not provide meaningful
protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the
agreements. In the event a competitor infringes upon one of our patents or other intellectual property rights, enforcing those patents
and rights may be difficult and time consuming. Even if successful, litigation to defend our patents against challenges or to enforce
our intellectual property rights could be expensive and time consuming and could divert management’s attention from managing our
business. Moreover, we may not have sufficient resources to defend our patents against challenges or to enforce our intellectual
property rights.
The medical device industry is characterized by patent and other intellectual property litigation and we could become subject to
litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, and/or prevent
us from marketing our existing or future products.
The medical device industry is characterized by extensive litigation and administrative proceedings over patent and other
intellectual property rights. Determining whether a product infringes a patent involves complex legal and factual issues, the
determination of which is often uncertain. Our competitors may assert that our products, the components of those products, the
methods of using those products, or the methods we employ in manufacturing or processing those products are covered by patents
held by them. In addition, they may claim that their patents have priority over ours because their patents were filed first. Because
patent applications can take many years to issue, there may be applications now pending of which we are unaware, which may later
result in issued patents that our products may infringe. There could also be existing patents that one or more components of our
30
products may be inadvertently infringing, of which we are unaware. As the number of participants in the market for spine disorder
devices and treatments increases, the possibility of patent infringement claims against us also increases.
Any such claim against us, even those without merit, may cause us to incur substantial costs, and could place a significant strain
on our financial resources, divert the attention of management from our core business and harm our reputation. If the relevant patents
are upheld as valid and enforceable and we are found to infringe, we could be required to pay substantial damages, including treble, or
triple, damages if an infringement is found to be willful, and/or royalties and we could be prevented from selling our products unless
we could obtain a license or were able to redesign our products to avoid infringement. Any such license may not be available on
reasonable terms, if at all, and there can be no assurance that we would be able to redesign our products in a way that would not
infringe those patents, and any such redesign, if possible, may be costly. If we fail to obtain any required licenses or make any
necessary changes to our products or technologies, we may have to withdraw existing products from the market or may be unable to
commercialize one or more of our products, either of which could have a significant adverse effect on our business, financial condition
and results of operations. We may lose market share to our competitors if we fail to protect our intellectual property rights.
In addition, in order to further our product development efforts, from time to time we enter into agreements with surgeons to
develop new products. As consideration for product development activities rendered pursuant to these agreements, in certain instances
we have agreed to pay such surgeons royalties on products developed by cooperative involvement between us and such surgeons.
There can be no assurance that surgeons with whom we have entered into such an arrangement will not claim to be entitled to a
royalty even if we do not believe that such products were developed by cooperative involvement between us and such surgeons. Any
such claim against us, even those without merit, may cause us to incur substantial costs, and could place a significant strain on our
financial resources, divert the attention of management from our core business and harm our reputation.
If we become subject to product liability claims, we may be required to pay damages that exceed our insurance coverage.
Our business exposes us to potential product liability claims that are inherent in the testing, design, manufacture and sale of
medical devices for spine surgery procedures. Spine surgery involves significant risk of serious complications, including bleeding,
nerve injury, paralysis and even death. To date, our products have not been the subject of any material product liability claims.
Currently, we carry product liability insurance in the amount of $20 million per occurrence and $20 million in the aggregate. Our
existing product liability insurance coverage may be inadequate to satisfy liabilities we might incur. Any product liability claim
brought against us, with or without merit, could result in the increase of our product liability insurance rates or our inability to secure
coverage in the future on commercially reasonable terms, if at all. In addition, if our product liability insurance proves to be
inadequate to pay a damage award, we may have to pay the excess out of our cash reserves, which could harm our financial condition.
If longer-term patient results and experience indicate that our products or any component of our products cause tissue damage, motor
impairment or other adverse effects, we could be subject to significant liability. Even a meritless or unsuccessful product liability
claim could harm our reputation in the industry, lead to significant legal fees and result in the diversion of management’s attention
from managing our business. If a product liability claim or series of claims is brought against us in excess of our insurance coverage
limits, our business could suffer and our financial condition, results of operations and cash flow could be materially adversely
impacted.
Because biologics products entail a potential risk of communicable disease to human recipients, we may be the subject of product
liability claims regarding our biologics products.
Our biologics products may expose us to additional potential product liability claims. The development of biologics products
entails a risk of additional product liability claims because of the risk of transmitting disease to human recipients, and substantial
product liability claims may be asserted against us. In addition, successful product liability claims made against one of our competitors
could cause claims to be made against us or expose us to a perception that we are vulnerable to similar claims. Even a meritless or
unsuccessful product liability claim could harm our reputation in the industry, lead to significant legal fees and result in the diversion
of management’s attention from managing our business.
Any claims relating to our improper handling, storage or disposal of biological, hazardous and radioactive materials could be time
consuming and costly.
The manufacture of certain of our products, including our biologics products, involves the controlled use of biological,
hazardous and/or radioactive materials and waste. Our business and facilities and those of our suppliers are subject to foreign, federal,
state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials and
waste products. Although we believe that our safety procedures for handling and disposing of these materials comply with legally
prescribed standards, we cannot completely eliminate the risk of accidental contamination or injury from these materials. In the event
of an accident, we could be held liable for damages or penalized with fines. This liability could exceed our resources and any
applicable insurance. In addition, under some environmental laws and regulations, we could also be held responsible for all of the
costs relating to any contamination at our past or present facilities and at third-party waste disposal sites, even if such contamination
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was not caused by us. We may incur significant expenses in the future relating to any failure to comply with environmental laws. Any
such future expenses or liability could have a significant negative impact on our business, financial condition and results of operations.
We may be subject to damages resulting from claims that we, our employees or our independent distributors have wrongfully used
or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our
competitors.
Many of our employees were previously employed at other medical device companies, including our competitors or potential
competitors. Many of our independent distributors sell, or in the past have sold, products of our competitors. We may be subject to
claims that we, our employees or our independent distributors have inadvertently or otherwise used or disclosed the trade secrets or
other proprietary information of our competitors. In addition, we have been and may in the future be subject to claims that we caused
an employee or independent distributor to break the terms of his or her non-competition agreement or non-solicitation agreement.
Litigation may be necessary to defend against such claims. Even if we are successful in defending against such claims, litigation could
result in substantial costs and be a distraction to management. If we fail in defending such claims, in addition to paying monetary
damages, we may lose valuable intellectual property rights and/or personnel. A loss of key personnel and/or their work product could
hamper or prevent our ability to commercialize products, which could have an adverse effect on our business, financial condition and
results of operations.
Risks Related to Our Common Stock
If we fail to continue to meet all applicable NASDAQ Global Select Market requirements and our common stock is delisted, the
delisting could adversely affect the market liquidity of our common stock, impair the value of your investment and harm our
business.
Our common stock is currently listed on the NASDAQ Global Select Market. In order to maintain that listing, we must satisfy
minimum financial and other requirements. On September 17, 2015, we received written notice from the Listing Qualifications
Department of the NASDAQ Stock Market LLC, or NASDAQ, notifying us that for the preceding 30 consecutive business days, our
common stock did not maintain a minimum closing bid price of $1.00 per share as required for continued inclusion on The NASDAQ
Global Select Market under NASDAQ Listing Rule 5450(a)(1). On August 24, 2016, we effected a 1-for-12 reverse stock split of our
common stock in order to regain compliance with the applicable NASDAQ Listing Rules that required us to maintain a minimum
closing bid price of $1.00 per share for a minimum of 10 consecutive trading days.
Accordingly, although we are currently in compliance with applicable NASDAQ Global Select Market requirements, if we fail
to continue to meet all such requirements in the future and NASDAQ determines to delist our common stock, the delisting could
substantially decrease trading in our common stock and adversely affect the market liquidity of our common stock; adversely affect
our ability to obtain financing on acceptable terms, if at all, to continue our operations; and may result in the potential loss of
confidence by investors, suppliers, customers and employees and fewer business development opportunities. Additionally, the market
price of our common stock may decline further and stockholders may lose some or all of their investment.
We expect that the price of our common stock will fluctuate substantially and the market price of our common stock may decline in
value in the future.
The market price of our common stock is likely to be highly volatile and may fluctuate substantially due to many factors,
including those described elsewhere in this “Risk Factors” section and the following:
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volume and timing of orders for our products;
quarterly variations in our or our competitors’ results of operations;
our announcement or our competitors’ announcements regarding new products, product enhancements, significant
contracts, number of distributors, number of hospitals and surgeons using products, acquisitions, and collaborative or
strategic investments;
announcements of technological or medical innovations for the treatment of spine pathology;
changes in earnings estimates or recommendations by securities analysts;
our ability to develop, obtain regulatory clearance or approval for, and market new and enhanced products on a timely
basis;
changes in healthcare policy in the U.S.;
product liability claims or other litigation involving us;
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sales of large blocks of our common stock, including sales by our executive officers, directors and significant
stockholders;
changes in governmental regulations or in the status of our regulatory approvals, clearances or applications;
disputes or other developments with respect to intellectual property rights;
changes in the availability of third-party reimbursement in the U.S.;
changes in accounting principles; and
general market conditions and other factors, including factors unrelated to our operating performance or the operating
performance of our competitors.
We may become involved in securities class action litigation that could divert management’s attention and harm our business.
The stock market in general, The NASDAQ Global Select Market and the market for medical device companies in particular,
has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating
performance of those companies. Further, the market prices of securities of medical device companies have been particularly volatile.
In the past, following periods of volatility in the market price of a particular company’s securities, securities class action litigation has
often been brought against that company. We may become involved in this type of litigation in the future. Litigation is often expensive
and diverts management’s attention and resources, which could materially harm our financial condition, results of operations and
business.
Securities analysts may not continue to provide coverage of our common stock or may issue negative reports, which may have a
negative impact on the market price of our common stock.
Securities analysts may not continue to provide research coverage of our common stock. If securities analysts do not cover our
common stock, the lack of research coverage may cause the market price of our common stock to decline. The trading market for our
common stock may be affected in part by the research and reports that industry or financial analysts publish about our business. If one
or more of the analysts who elects to cover us downgrades our stock, our stock price would likely decline rapidly. If one or more of
these analysts ceases coverage of us, we could lose visibility in the market, which in turn could cause our stock price to decline. In
addition, it may be difficult for companies such as ours, with smaller market capitalizations, to attract independent financial analysts
that will cover our common stock. This could have a negative effect on the market price of our stock.
Because of their significant stock ownership, our executive officers, directors and principal stockholders will be able to exert
control over us and our significant corporate decisions.
Based on shares outstanding at March 17, 2017, our executive officers, directors and stockholders holding more than 5% of our
outstanding common stock and their affiliates, in the aggregate, beneficially own approximately 35% of our outstanding common
stock. As a result, these persons will have the ability to impact significantly the outcome of all matters requiring stockholder approval,
including the election and removal of directors and any merger, consolidation, or sale of all or substantially all of our assets.
This concentration of ownership may harm the market price of our common stock by, among other things:
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delaying, deferring or preventing our change in control;
impeding a merger, consolidation, takeover or other business combination involving us;
causing us to enter into transactions or agreements that are not in the best interests of all of our stockholders; or
reducing our public float held by non-affiliates.
Certain members of our Board of Directors also serve as officers and directors of HealthpointCapital, its affiliates and other
portfolio companies.
Three members of our Board of Directors also serve as officers and directors of our largest stockholder, HealthpointCapital, or
its related entities and of other companies in which HealthpointCapital invests, including companies with which we compete or may in
the future compete. As of March 17, 2017, HealthpointCapital owned approximately 31% of our outstanding common stock. The
Chairman of our Board of Directors, Mortimer Berkowitz III, is a managing member of HGP, LLC and HGP II, LLC, the general
partners of HealthpointCapital Partners, LP and HealthpointCapital Partners II, LP, respectively. Our directors R. Ian Molson and
Stephen E. O’Neil also serve on the board of managers of HealthpointCapital, LLC. Each of Messrs. Berkowitz, O’Neil and Molson,
also have financial interests in HealthpointCapital investment funds.
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Because of these possible conflicts of interest, such directors may direct potential business and investment opportunities to other
entities rather than to us or such directors may undertake or otherwise engage in activities or conduct on behalf of such other entities
that is not in, or which may be adverse to, our best interests. Whether a director directs an opportunity to us or to another company,
our directors may face claims of breaches of fiduciary duty and other duties relating to such opportunities. Our amended and restated
certificate of incorporation requires us to indemnify our directors to the fullest extent permitted by law, which may require us to
indemnify them against claims of breaches of such duties arising from their service on our Board of Directors. HealthpointCapital or
its affiliates may pursue acquisition opportunities that may be complementary to our business and, as a result, those acquisition
opportunities may not be available to us. Furthermore, HealthpointCapital may have an interest in us pursuing acquisitions,
divestitures, financings or other transactions that, in its judgment, could enhance its equity investment, even though such transactions
might involve risks to us and our stockholders generally. In addition, if we were to seek a business combination with a target business
with which one or more of our existing stockholders or directors may be affiliated, conflicts of interest could arise in connection with
negotiating the terms of and completing the business combination. Conflicts that may arise may not be resolved in our favor.
Anti-takeover provisions in our organizational documents and change of control provisions in some of our employment
agreements and agreements with distributors, and in some of our outstanding debt agreements, as well as the terms of our
redeemable preferred stock, may discourage or prevent a change of control, even if an acquisition would be beneficial to our
stockholders, which could affect our stock price adversely.
Certain provisions of our amended and restated certificate of incorporation and restated by-laws could discourage, delay or
prevent a merger, acquisition or other change in control that stockholders may consider favorable, including transactions in which our
stockholders might otherwise receive a premium for their shares. These provisions also could limit the price that investors might be
willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. Stockholders
who wish to participate in these transactions may not have the opportunity to do so. Furthermore, these provisions could prevent or
frustrate attempts by our stockholders to replace or remove our management. These provisions:
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allow the authorized number of directors to be changed only by resolution of our Board of Directors;
allow vacancies on our Board of Directors to be filled only by resolution of our Board of Directors;
authorize our Board of Directors to issue, without stockholder approval, blank check preferred stock that, if issued, could
operate as a “poison pill” to dilute the stock ownership of a potential hostile acquirer to prevent an acquisition that is not
approved by our Board of Directors;
require that stockholder actions must be effected at a duly called stockholder meeting and prohibit stockholder action by
written consent;
establish advance notice requirements for stockholder nominations to our Board of Directors and for stockholder
proposals that can be acted on at stockholder meetings; and
limit who may call stockholder meetings.
Some of our employment agreements and all of our restricted stock agreements, incentive stock option agreements,
performance-based stock units and restricted common stock provide for accelerated vesting of benefits, including full vesting of
restricted stock and options, upon a change of control. A limited number of our agreements with our distributors include a provision
that extends the term of the distribution agreement upon a change in control and makes it more difficult for us or our successor to
terminate the agreement. These provisions may discourage or prevent a change of control.
In addition, in the event of a change of control, we would be required to redeem all outstanding shares of our redeemable
preferred stock for an aggregate of $29.9 million, at the price of $9.00 per share. Further, our amended and restated certificate of
incorporation permits us to issue additional shares of preferred stock. The terms of our redeemable preferred stock or any new
preferred stock we may issue could have the effect of delaying, deterring or preventing a change in control.
Our stockholders will not receive any distribution of the proceeds from the sale of our international distribution operations and we
do not anticipate paying any cash dividends in the foreseeable future, and stockholders may never receive any return of value.
We did not distribute to stockholders any cash proceeds from the Globus Transaction. Instead, we used a portion of the proceeds
from the Globus Transaction to repay in full all amounts outstanding and due under our Deerfield Facility Agreement and repay
certain of our outstanding indebtedness under our Amended Credit Facility with MidCap, and we intend to use the remainder of the
proceeds to fund our future business activities and for general working capital purposes. Any future decision for the use of those funds
will be made by our Board of Directors.
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In addition, we have not declared any cash dividends and do not intend to declare or pay any cash dividends in the foreseeable
future. Future earnings, if any, will be used to finance the future operation and growth of our business. Any determination to pay
dividends in the future will be at the discretion of our Board of Directors and will depend upon results of operations, financial
condition, contractual restrictions, restrictions imposed by applicable law and other factors our Board of Directors deems relevant. In
addition, our ability to pay dividends is currently restricted by the terms of our Amended Credit Facility with MidCap and Globus
Facility Agreement. Stockholders will not receive any liquidity from the Globus Transaction and the only return to them will be based
on any future appreciation in our stock price or upon a future sale or liquidation of our company, which may never occur. Much
depends on our future business, including the success or failure of our U.S. business. There are no assurances that we will be
successful, and current stockholders may never get a return on their investment.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K and, in particular, the description of our "Business" set forth in Item 1, the "Risk Factors" set
forth in this Item 1A and our "Management’s Discussion and Analysis of Financial Condition and Results of Operations" set forth in
Item 7 contain or incorporate a number of forward-looking statements within the meaning of Section 27A of the Securities Act of
1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act,
including statements regarding:
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our estimates regarding anticipated operating losses, future revenue, expenses, capital requirements, uses and sources of
cash and liquidity, including our anticipated revenue growth and cost savings;
our ability to meet the financial covenants under our credit facilities;
our ability to ensure that we have effective disclosure controls and procedures;
•
our not realizing the full economic benefit from the Globus Transaction, including as a result of indemnification claims
under the definitive agreement and the retention by us of certain liabilities associated with the international business, and
our ability to meet our obligations under the Globus supply agreement;
our ability to meet and potential liability from not meeting the payment obligations under the Orthotec settlement
agreement;
our ability to regain and maintain compliance with the quality requirements of the FDA;
our ability to market, improve, grow, commercialize and achieve market acceptance of any of our products or any product
candidates that we are developing or may develop in the future;
our beliefs about the features, strengths and benefits of our products;
our ability to continue to enhance our product offerings, outsource our manufacturing operations and expand the
commercialization of our products, and the effect of our strategy;
our expectations about the timing, costs and benefits of the restructuring and outsourcing of our manufacturing operations;
our beliefs about the ability of our supplier relationships and quality processes to fulfill our production requirements;
our ability to successfully integrate, and realize benefits from licenses and acquisitions;
the effect of any existing or future federal, state or international regulations on our ability to effectively conduct our
business;
our estimates of market sizes and anticipated uses of our products;
our business strategy and our underlying assumptions about market data, demographic trends, reimbursement trends and
pricing trends;
our ability to achieve profitability, and the potential need to raise additional funding;
our ability to maintain an adequate sales network for our products, including to attract and retain independent distributors;
our ability to enhance our U.S. distribution network;
our ability to increase the use and promotion of our products by training and educating surgeons and our sales network;
our ability to attract and retain a qualified management team, as well as other qualified personnel and advisors;
our ability to enter into licensing and business combination agreements with third parties and to successfully integrate the
acquired technology and/or businesses;
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our management team’s ability to accommodate growth and manage a larger organization;
our ability to protect our intellectual property, and to not infringe upon the intellectual property of third parties;
the effects of the escalating cost of medical products and services and the effects of market demand, government
regulation, third-party reimbursement policies and societal pressures on the healthcare industry and our business;
our ability to meet or exceed the industry standard in clinical and legal compliance and corporate governance programs;
our beliefs about our competitors and the principal competitive factors in our market and the effect of non-operative
treatments on demand for our products;
potential liability resulting from litigation;
our beliefs about our employee relations;
potential liability resulting from a governmental review of our business practices;
our beliefs about the usefulness of the non-GAAP financial measures included in this Annual Report on Form 10-K;
our beliefs with respect to our critical accounting policies and the reasonableness of our estimates and assumptions; and
other factors discussed elsewhere in this Annual Report on Form 10-K or any document incorporated by reference herein
or therein.
Any or all of our forward-looking statements in this Annual Report may turn out to be wrong. They can be affected by
inaccurate assumptions by known or unknown risks and uncertainties. Many factors mentioned in our discussion in this Annual Report
on Form 10-K will be important in determining future results. Consequently, no forward-looking statement can be guaranteed. Actual
future results may vary materially from expected results.
We also provide a cautionary discussion of risks and uncertainties under “Risk Factors” in Item 1A of this Annual Report. These
are factors that we think could cause our actual results to differ materially from expected results. Other factors besides those listed
there could also adversely affect us.
Without limiting the foregoing, the words “believe,” “anticipate,” “plan,” “expect,” “may,” “could,” “would,” “seek,” “intend,”
and similar expressions are intended to identify forward-looking statements. There are a number of factors and uncertainties that could
cause actual events or results to differ materially from those indicated by such forward-looking statements, many of which are beyond
our control, including the factors set forth under “Item 1A Risk Factors.” In addition, the forward-looking statements contained herein
represent our estimate only as of the date of this filing and should not be relied upon as representing our estimate as of any subsequent
date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any
obligation to do so to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking
statements, except as required by applicable law.
Item 1B.
Unresolved Staff Comments
None.
Item 2.
Properties
Our corporate office is located in Carlsbad, California. The table below provides selected information regarding our current
material operating location.
Location
Carlsbad, California
Use
Corporate headquarters and product design
Approximate
Square
Footage
76,693
Lease Expiration
July 2021
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Item 3.
Legal Proceedings
We are and may become involved in various legal proceedings arising from our business activities. While management is not
aware of any litigation matter that in and of itself would have a material adverse impact on our consolidated results of operations, cash
flows or financial position, litigation is inherently unpredictable, and depending on the nature and timing of a proceeding, an
unfavorable resolution could materially affect our future consolidated results of operations, cash flows or financial position in a
particular period. We assess contingencies to determine the degree of probability and range of possible loss for potential accrual or
disclosure in our consolidated financial statements. An estimated loss contingency is accrued in our consolidated financial statements
if it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Because litigation is
inherently unpredictable and unfavorable resolutions could occur, assessing contingencies is highly subjective and requires judgments
about future events. When evaluating contingencies, we may be unable to provide a meaningful estimate due to a number of factors,
including the procedural status of the matter in question, the presence of complex or novel legal theories, and/or the ongoing discovery
and development of information important to the matters. In addition, damage amounts claimed in litigation against us may be
unsupported, exaggerated or unrelated to reasonably possible outcomes, and as such are not meaningful indicators of our potential
liability.
Item 4.
Mine Safety Disclosures
Not applicable.
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PART II
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market Information
Our common stock is traded on The NASDAQ Global Select Market under the symbol “ATEC.” The following table sets forth
the high and low sales prices for our common stock as reported on The NASDAQ Global Select Market for the periods indicated.
On August 24, 2016, we effected a 1-for-12 reverse stock split of our issued and outstanding common stock. The per-share
amounts listed in the table below are adjusted for all periods to reflect our 1-for-12 reverse stock split.
Year Ended December 31, 2016
First quarter
Second quarter
Third quarter
Fourth quarter
Year Ended December 31, 2015
First quarter
Second quarter
Third quarter
Fourth quarter
$
$
High
Low
6.96 $
4.56
9.65
9.27
1.80
2.16
2.64
3.12
High
Low
18.48 $
17.76
17.16
5.40
15.36
15.36
3.84
2.16
Stockholders
As of March 24, 2017, there were approximately 210 holders of record of an aggregate 9,048,145 outstanding shares of our
common stock.
Dividend Policy
We have never declared or paid cash dividends on our capital stock. We currently intend to retain all available funds and any
future earnings for use in the operation and expansion of our business and do not anticipate paying any cash dividends in the
foreseeable future. In addition, our ability to pay dividends is currently restricted by the terms of the Amended Credit Facility with
MidCap and the Globus Facility Agreement.
Issuer Purchases of Equity Securities
Under the terms of our 2016 Equity Incentive Plan and our Amended and Restated 2005 Employee, Director and Consultant
Stock Plan, as amended, which we refer to collectively as the Stock Plans, and prior to the expiration of the Stock Plans in May 2026,
we are permitted to award shares of restricted stock to our employees, directors and consultants. These shares of restricted stock are
subject to a lapsing right of repurchase by us. We may exercise this right of repurchase in the event that a restricted stock recipient’s
employment, directorship or consulting relationship with us terminates prior to the end of the vesting period. If we exercise this right,
we are required to repay the purchase price paid by or on behalf of the recipient for the repurchased restricted shares. Repurchased
shares are returned to the Stock Plan and are available for future awards under the terms of the Stock Plan. There were no shares of
common stock repurchased during the year ended December 31, 2016.
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Item 6.
Selected Financial Data
The following table sets forth consolidated financial data with respect to the Company for each of the five years in the period
ended December 31, 2016. The selected consolidated financial data set forth below have been derived from our audited consolidated
financial statements, and may not be indicative of future operating results. The results of operations for the year ended December 31,
2015 include a goodwill and intangible assets impairment charge of $164.3 million. The results of operations for the year ended
December 31, 2013 include litigation settlement expenses of $46.0 million. The selected consolidated financial data set forth below
should be read in conjunction with our audited consolidated financial statements and related notes thereto found at “Item 8 Financial
Statements and Supplementary Data” and “Item 7 Management’s Discussion and Analysis of Financial Condition and Results of
Operations” included elsewhere in this Annual Report on Form 10-K.
The following amounts related to earnings per share and shares outstanding have been adjusted for all periods reported for the 1-
for-12 reverse stock split that we effected on August 24, 2016.
As a result of the Globus Transaction, our International Business (as defined in Item 7 below) has been excluded from
continuing operations for all periods presented in this report and is reported as discontinued operations. See Note 4 for additional
information on the divestiture of the International Business.
Consolidated Statement of Operations Data:
Revenues
Income (Loss) from continuing operations
Loss from discontinued operations
Net loss
Net loss per basic share
Net loss per diluted share
Weighted-average shares used in computing net loss
per share:
Shares used in calculating basic net loss per share
Shares used in calculating diluted net loss per share
Consolidated Balance Sheet Data:
Cash
Restricted cash
Working capital (deficit)
Total assets
Total debt, including current portion
Redeemable preferred stock
Total stockholders’ (deficit) equity
2016
Year Ended December 31,
2015
2013
2014
(in thousands, except per share amounts)
2012
$
$
$
$
$
134,388
$
120,248
(171,253)
(26,301)
(3,624)
(7,423)
(29,925) $ (178,676) $
(21.53) $
(21.53) $
(3.49) $
(3.49) $
154,625
$
(98)
(12,784)
(12,882) $
(1.59) $
(1.90) $
$
148,263
(63,629)
(18,598)
(82,227) $
(10.25) $
(10.25) $
141,355
(5,616)
(9,843)
(15,459)
(2.06)
(2.06)
8,582
8,582
8,298
8,298
8,112
8,145
8,020
8,020
7,518
7,518
2016
2015
As of December 31,
2014
(in thousands)
2013
2012
$
$
$
19,593
—
32,689
94,188
46,205
23,603
(41,504)
$
6,295
2,350
(23,542)
146,341
80,222
23,603
(36,576)
12,595
4,400
49,511
113,112
82,673
23,603
148,954
$
16,102
—
34,026
365,630
54,888
23,603
171,676
16,921
—
65,264
382,127
41,619
23,603
245,816
39
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion of our financial condition and results of operations should be read in conjunction with the financial
statements and the notes to those statements appearing elsewhere in this Annual Report on Form 10-K. Some of the information
contained in this discussion and analysis or set forth elsewhere in this report include the identification of certain trends and other
statements that may predict or anticipate future business or financial results that are subject to important factors that could cause our
actual results to differ materially from those indicated. See “Item 1A Risk Factors” included elsewhere in this Annual Report on Form
10-K.
Overview
We are a medical technology company focused on the design, development and promotion of products for the surgical treatment
of spine disorders. Our mission is to improve patient lives by delivering advancements in spinal fusion technologies. We have a
comprehensive product portfolio and pipeline that addresses the cervical, thoracolumbar and intervertebral regions of the spine and
covers a variety of spinal disorders and surgical procedures. Our principal product offerings are focused on the U.S. market for fusion-
based spinal disorder solutions. We believe that our products and systems are attractive to surgeons and patients due to innovative
features and benefits that simplify surgical procedures for the surgeon and improve patient outcomes.
Currently, we market and sell our products in the United States through a network of non-exclusive independent distributors and
direct sales representatives. We believe there is significant opportunity for us to partner closely with distributors to create a more
dedicated and loyal sales channel for the future. We are eliminating our stocking distributors and are moving our existing distributor
relationships to more dedicated and non-competitive partnerships and we intend to add new, high-quality distributors to enable future
growth.
We believe this will allow us to reach an untapped market of surgeons, hospitals and national accounts across the United States,
as well as further penetrate existing accounts and territories.
We also employ a national accounts team that is responsible for securing access at hospitals and group purchasing organizations,
or GPOs, across the United States. We have had strong success with securing access to hospitals and GPOs. We believe that this
access is a key differentiator for us, and much of our current business is achieved through these accounts. We will continue to focus
our efforts and investment on developing and maintaining relationships with key GPOs and hospital networks in order to secure
favorable contracts and develop strategies to convert or grow business within existing accounts.
We are also striving to drive additional revenue by focusing our capital spend on making strategic investments in
commercializing our new products. We are focusing our development and commercialization efforts on differentiated products that we
can market through our sales channel. These innovative products are designed to drive penetration within specific segments within the
overall spine market, including the complex spine, deformity, and lateral markets. We also plan to expand our biologics portfolio
through structural allograft, tissue and synthetic bone graft products to support surgeons during the surgical procedure with the goal of
achieving high fusion rates.
Recent Developments
On March 29, 2017, we completed a Private Placement of our securities to certain institutional and accredited investors,
including certain directors and executive officers of the Company, providing for the sale by the Company of 1,809,628 shares of our
common stock at a purchase price of $2.00 per share, 15,245 shares of newly designated Series A Convertible Preferred Stock (the
“Series A Convertible Preferred Stock”) at a purchase price of $1,000 per share (which Preferred Shares are convertible into
approximately 7,622,372 shares of our common stock, subject to limitations on conversion until the approval by our stockholders as
required in accordance with the NASDAQ Global Select Market rules), and warrants to purchase up to 9,432,000 shares of our
Common Stock at an exercise price of $2.00 per share (the “Warrants”), in a private placement (the “Private Placement”). The
Warrants will become exercisable following stockholder approval, are subject to certain ownership limitations, and expire five years
after the date of such Stockholder approval. The aggregate gross proceeds for the Private Placement were approximately $18.9
million. We intend to use the net proceeds from the Private Placement for general corporate and working capital purposes.
On September 1, 2016, we completed the sale of our international distribution operations and agreements, including our wholly-
owned subsidiaries in Japan, Brazil, Australia, China and Singapore and substantially all of the assets of our other sales operations in
the United Kingdom and Italy, or collectively the International Business, to an affiliate of Globus. Following the closing of the Globus
Transaction, we now operate in the U.S. market only and are prohibited from marketing and selling our products in foreign markets
pursuant to the terms and conditions, and for the time periods, set forth in the definitive documents related to the Globus Transaction.
40
At the closing of the Globus Transaction on September 1, 2016, Globus paid us $80 million in cash, subject to a working capital
adjustment. On September 1, 2016, we used approximately $66 million of the consideration received to (i) repay in full all amounts
outstanding and due under the Deerfield Facility Agreement, and (ii) repay certain of our outstanding indebtedness under our
Amended Credit Facility, in each case, including debt-related costs. Also on September 1, 2016, we entered into the credit, security
and guaranty agreement with Globus, or the Globus Facility Agreement, pursuant to which Globus has agreed to loan us up to $30
million, subject to the terms and conditions set forth in the Globus Facility Agreement.
As a result of the sale of our International Business, we have retrospectively revised the consolidated statements of operations
for the years ended December 31, 2016, 2015 and 2014, the consolidated statements of cash flows for the years ended December 31,
2016, 2015 and 2014, and the consolidated balance sheets as of December 31, 2016 and 2015, to reflect the financial results from the
International Business, and the related assets and liabilities, as discontinued operations.
On August 24, 2016, we filed a certificate of amendment to the Company’s certificate of incorporation with the Secretary of
State of the state of Delaware to effectuate a 1-for-12 reverse stock split of our issued and outstanding common stock. The share and
per share amounts in the discussion below gives retrospective effect to the 1-for-12 reverse stock split for all periods presented.
Revenue and Expense Components
The following is a description of the primary components of our revenues and expenses:
Revenues. We derive our revenues primarily from the sale of spinal surgery implants used in the treatment of spine disorders.
Spinal implant products include pedicle screws and complementary implants, interbody devices, plates, and tissue-based materials.
Our revenues are generated by our direct sales force and independent distributors. Our products are requested directly by surgeons and
shipped and billed to hospitals and surgical centers. Currently, most of our business is conducted with customers within markets in
which we have experience and with payment terms that are customary to our business. We may defer revenues until the time of
collection if circumstances related to payment terms, regional market risk or customer history indicate that collectability is not
reasonably assured.
Cost of revenues. Cost of revenues consists of direct product costs, royalties, milestones, depreciation of our surgical
instruments, and the amortization of purchased intangibles. Our product costs consist primarily of direct labor, overhead, and raw
materials and components. The product costs of certain of our biologics products include the cost of procuring and processing human
tissue. We incur royalties related to the technologies that we license from others and the products that are developed in part by
surgeons with whom we collaborate in the product development process. Amortization of purchased intangibles consists of
amortization of developed product technology.
Research and development. Research and development expense consists of costs associated with the design, development,
testing, and enhancement of our products. Research and development expense also includes salaries and related employee benefits,
research-related overhead expenses, fees paid to external service providers in both cash and equity, and costs associated with our
Scientific Advisory Board and Executive Surgeon Panels.
In-process research and development, or IPR&D. IPR&D expense consists of acquired research and development assets that
were not part of an acquisition of a business and were not technically feasible on the date we acquired such technology, provided that
such technology also did not have any alternative future use at that date.
Sales and marketing. Sales and marketing expense consists primarily of salaries and related employee benefits, sales
commissions and support costs, professional service fees, travel, medical education, trade show and marketing costs.
General and administrative. General and administrative expense consists primarily of salaries and related employee benefits,
professional service fees, insurance and legal expenses.
Goodwill and intangible assets impairment. The impairment expense relates to impairment charges related to our goodwill
balances and intangible assets.
Restructuring expenses. Restructuring expense consists of severance, social plan benefits and related taxes, facility closing
costs, manufacturing transfer costs and severance costs incurred following the sale of our International Business and the termination of
our manufacturing operations in California.
Total other income (expense). Total other income (expense) includes interest income, interest expense, changes in the fair value
of the warrant liabilities, gains and losses from foreign currency exchanges and other non-operating gains and losses.
41
Income tax (benefit) provision. Income tax benefit from continuing operations consists primarily of domestic losses partially
offset by state income taxes. ASC 740-20 requires total income tax expense or benefit to be allocated among continuing operations,
discontinued operations, extraordinary items, other comprehensive income and items charged directly to shareholders’ equity. This
allocation is referred to as intra-period tax allocation. The sale of the Company's international distribution operations and several
foreign subsidiaries is reported under discontinued operations in the Consolidated Financial Statements. Accordingly, we are required
to allocate the provision for income taxes between continuing operations and discontinued operations. For the year ended December
31, 2016, we recognized a gain from discontinued operations before tax, and, as a result, we recorded a tax expense of $6.5 million in
discontinued operations and a corresponding tax benefit to continuing operations
Results of Operations
The first table below sets forth our statements of operations data for the periods presented. Our historical results are not
necessarily indicative of the operating results that may be expected in the future.
Revenues
Cost of revenues
Gross profit
Operating expenses:
Research and development
In-process research and development
Sales and marketing
General and administrative
Amortization of intangible assets
Goodwill and intangible assets impairment
Restructuring expenses
Total operating expenses
Operating (loss) income
Other income (expense):
Interest income
Interest expense
Loss on debt extinguishment
Other income (expense), net
Total other income (expense)
Pretax income (loss) from continuing operations
Income tax (benefit) provision
Loss from continuing operations
Loss from discontinued operations, net of taxes
Net loss
$
2016
Year Ended December 31,
2015
(in thousands)
2014
$
120,248 $
44,114
76,134
134,388 $
46,366
88,022
154,625
44,958
109,667
9,248
—
50,962
26,339
934
1,736
2,292
91,511
(15,377)
3
(5,368)
(9,478)
(715)
(15,558)
(30,935)
(4,634)
(26,301)
(3,624)
(29,925) $
17,615
274
51,801
28,126
1,200
164,263
597
263,876
(175,854)
11
(4,001)
—
7,445
3,455
(172,399)
(1,146)
(171,253)
(7,423)
(178,676) $
16,593
527
55,782
34,048
1,232
—
—
108,182
1,485
10
(3,022)
—
1,836
(1,176)
309
407
(98)
(12,784)
(12,882)
Year Ended December 31, 2016 Compared to the Year Ended December 31, 2015
Revenues. Revenues were $120.2 million for the year ended December 31, 2016 compared to $134.4 million for the year ended
December 31, 2015, representing a decrease of $14.1 million, or 10.5%. The decrease was the result of a decline in the sales amounts
to former subsidiaries that are classified in continuing operations ($9.1 million) and a decrease in U.S. revenues ($7.6 million), offset
by sales beginning in 2016 to Globus ($2.6 million). The sale of implants and instruments to U.S. hospitals decreased by $1.8 million
due to pricing erosion in the mid-single digits, consistent with trends experienced over the past several years, partially offset by an
increase in unit volume. The sales to stocking distributors declined from the prior year in the amount of $5.8 million due to the
ongoing initiative to eliminate this channel from our U.S. Commercial business.
42
Cost of revenues. Cost of revenues was $44.1 million for the year ended December 31, 2016 compared to $46.4 million for the
year ended December 31, 2015, representing a decrease of $2.3 million, or 4.9%. The decrease was the result of an elimination of one-
time costs related to 2015 activities ($4.5 million), a reduction in product costs due primarily to lower sales volumes ($1.5 million), a
reduction in inventory adjustments ($0.4 million) and a reduction in depreciation and amortization expenses ($0.5 million), offset by
an increase in inventory reserves due to excess inventory quantities and product life cycle management activities ($2.9 million),
charges related to the discontinuation of a product and the related intangible assets and inventory ($1.6 million) and an increase in
royalty expense ($0.2 million). The one-time costs related to 2015 activities include multiple product discontinuations, loss on
equipment disposals, and accelerated depreciation related to the restructuring of manufacturing operations, offset by gains recognized
in 2016 on the sale of various manufacturing equipment related to the 2015 restructuring of operations.
Gross profit. Gross profit was $76.1 million for the year ended December 31, 2016 compared to $88.0 million for the year
ended December 31, 2015, representing a decrease of $11.9 million, or 13.5%. The decrease was a combination of a decline in gross
profit on sales to former subsidiaries that are classified in continuing operations ($4.1 million) and the effect of lower U.S. revenues
combined with an increase in the cost of revenues ($7.8 million), offset by the reduction in cost of sales due to the elimination of one-
time costs related to 2015 activities ($4.5 million).
Gross Margin, Gross Margin was 63.3% for the year ended December 31, 2016 compared to 65.5% for the year ended
December 31 2015. The decrease of 2.2 percentage points was the result of an increase in inventory reserves and adjustments (2.5
percentage points), charges related to the discontinuation of a product and the related intangible assets and inventory (1.3 percentage
points), a reduction in pricing related to revenues (1.1 percentage points), an increase in royalty expense (0.5 percentage points) and an
increase in depreciation expense (0.4 percentage points), offset by the reduction in cost of sales due to the elimination of one-time
costs related to 2015 activities (3.4 percentage points) and a reduction in amortization expense (0.2 percentage points).
Gross Margin, excluding intercompany and Globus revenue of $13.3 million and $19.8 million for the year ended December 31,
2016 and 2015, respectively, was 67.0% for the year ended December 31, 2016 compared to 69.4% for the year ended December 31
2015. The decrease of 2.4 percentage points was the result of an increase in inventory reserves (2.8 percentage points), charges related
to the discontinuation of a product and the related intangible assets and inventory (1.5 percentage points), an increase in product costs
due primarily to negative costs variances related to reduced sourcing volumes (1.3 percentage points), a reduction in pricing related to
revenues (0.9 percentage points), an increase in royalty expense (0.2 percentage points) and an increase in depreciation expense (0.3
percentage points), offset by the reduction in cost of sales due to the elimination of one-time costs related to 2015 activities (4.0
percentage points), a reduction in amortization expense (0.3 percentage points) and a reduction in inventory adjustments (0.3
percentage points).
Research and development. Research and development expense was $9.2 million for the year ended December 31, 2016
compared to $17.6 million for the year ended December 31, 2015 representing a decrease of $8.4 million, or 47.5%. The decrease was
related to a reduction of development activities ($3.7 million), a reduction in stock-based compensation related costs under a
consulting agreement ($2.9 million) and a reduction in personnel related costs ($1.8 million).
In-process research and development. IPR&D expense was $0.0 million for the year ended December 31, 2016 compared to
$0.3 million for the year ended December 31, 2015. The expense in 2015 relates to initial purchase payments in connection with asset
purchase agreements for which the underlying product was not technologically feasible at the time the asset was acquired.
Sales and marketing. Sales and marketing expense was $51.0 million for the year ended December 31, 2016 compared to $51.8
million for the year ended December 31, 2015 representing a decrease of $0.8 million, or 1.6%. The decrease was the result of a
reduction personnel and related expenses ($2.6 million) and the elimination of the medical device excise tax ($1.2 million), offset by
an increase in sales commissions to third party agents ($3.0 million).
General and administrative. General and administrative expense was $26.3 million for the year ended December 31, 2016
compared to $28.1 million for the year ended December 31, 2015, representing a decrease of $1.8 million, or 6.4%. The decrease was
primarily due to a reduction in personnel and related expenses ($2.6 million), a reduction in expenses related to information
technology ($0.5 million), offset by an increase in consulting and professional fees ($1.3 million).
Amortization of intangible assets. Amortization of intangible assets was $0.9 million for the year ended December 31, 2016 as
compared to $1.2 million for the year ended December 31, 2015. This expense represents amortization in the period for intangible
assets associated with general business assets which has declined as those assets have either been impaired or become fully amortized.
Goodwill and intangible assets impairment. The goodwill and intangible assets impairment was $1.7 million for the year ended
December 31, 2016 compared to $164.3 million for the year ended December 31, 2015. The 2016 impairment charge relates to
intangible assets that we found to be impaired as a result of the Globus Transaction. The 2015 impairment charge was primarily the
result of our goodwill impairment test performed during the third quarter of 2015 triggered by the decline in our share price which
resulted in the write off of all of our goodwill.
43
Restructuring expenses. Restructuring expenses were $2.3 million for the year ended December 31, 2016 compared to $0.6
million for the year ended December 31, 2015. Due to the closing of the Globus Transaction, which eliminated substantially all of our
international operations, we began a corporate downsizing initiative to align our cost structure with our current operations. The
restructuring costs for the year ended December 31, 2016 consist primarily of severance charges related to headcount reductions ($2.0
million). In July 2015, we announced a restructuring of our manufacturing operations in California in an effort to improve our cost
structure. As of December 31, 2016, the manufacturing restructuring was substantially complete and we recorded expenses of
approximately $0.3 million in the year ended December 31, 2016 and $0.6 million in the year ended December 31, 2015.
Interest expense. Interest expense was $5.4 million for the year ended December 31, 2016 compared to $4.0 million for the year
ended December 31, 2015, representing an increase of $1.4 million, or 34.2%. This increase is primarily related to greater costs in
connection with various amendments to our credit facilities with MidCap and the new credit facility with Globus.
Loss on extinguishment of debt. Loss on extinguishment of debt was $9.5 million for the year ended December 31, 2016. The
loss on extinguishment of debt is due to prepayment premium of $5.6 million and the write-off of unamortized debt costs of $3.9
million related to extinguishment of the Deerfield facility.
Other income (expense), net. Other income (expense), net was expense of $0.7 million for the year ended December 31, 2016
compared to income of $7.4 million for the year ended December 31, 2015, representing a decrease in income of $8.2 million. The
decrease in income is primarily the result of the decrease in warrant valuation in 2015 of $8.0 million due to the decline in the value of
our common stock that occurred in July 2015, compared to an expense of the warrant valuation in 2016 of $0.3 million.
Income tax (benefit) provision. Income tax (benefit) provision for continuing operations was a benefit of ($4.6) million for the
year ended December 31, 2016 compared to a benefit of ($1.1) million for the year ended December 31, 2015, representing an
increase benefit of $3.5 million. The 2016 income tax benefit from continuing operations consists of the income tax benefit related to
domestic losses partially offset by state income taxes. The 2015 income tax benefit from continuing operations consists primarily of
the reversal of deferred tax liabilities associated with tax deductible goodwill, partially offset by state income taxes. We are required
allocate the provision for income taxes between continuing operations and other categories of earnings, such as discontinued
operations.
Discontinued operations. On July 25, 2016, we entered into the Purchase and Sale Agreement with Globus whereby we agreed
to sell all of our International Business to Globus, including our wholly-owned subsidiaries in Japan, Brazil, Australia, China and
Singapore and substantially all of the assets of our other sales operations in the United Kingdom and Italy, and on September 1, 2016,
we completed the sale to Globus. As a result of our strategic decision to sell the International Business and focus on U.S market, our
consolidated statements of operations and the consolidated balance sheets reflect the financial results from the International Business
as discontinued operations for all periods presented.
For the year ended December 31, 2016, activity presented under discontinued operations in the consolidated statements of
operations represents our commercial operations prior to the sale of the International Business in September 2016 including certain
intercompany sales transactions as the Company will have continuing involvement due to future sales to Globus under the Supply
Agreement. Certain operating expenses were also allocated to the business activities associated with the discontinued operations as
well as interest expense related to our debt that we repaid using the proceeds from the sale of the International Business.
Year Ended December 31, 2015 Compared to the Year Ended December 31, 2014
Revenues. Revenues were $134.4 million for the year ended December 31, 2015 compared to $154.6 million for the year ended
December 31, 2014, representing a decrease of $20.2 million, or 13.1%. The decrease was the result of a decrease in U.S. revenues
($22.5 million), offset by an increase in the sales amounts to former subsidiaries ($2.3 million) that are classified in continuing
operations. The sale of implants and instruments to U.S. hospitals decreased by $18.9 million due to pricing erosion in the mid-single
digits, consistent with trends experienced over the past several years in conjunction with a significant decrease in unit volume. The
sales to stocking distributors in the U.S. declined from the prior year in the amount of $3.6 million.
Cost of revenues. Cost of revenues was $46.4 million for the year ended December 31, 2015 compared to $45.0 million for the
year ended December 31, 2014, representing an increase of $1.4 million, or 3.0%. The increase was the result of one-time charges for
the impairment of certain product-related intangible assets and the disposal of manufacturing equipment ($1.9 million), non-recurring
favorable royalties and milestones in 2014 ($1.2 million), an increase in manufacturing depreciation expense due to the reduction of
useful lives resulting from the manufacturing outsourcing initiative ($1.5 million), offset by a reduction in product costs due primarily
to lower sales volumes ($0.9 million), a reduction in reserves and adjustments ($0.8 million), reduced instrument depreciation expense
($0.6 million), a reduction in royalty and milestone expenses due to a reduction sales volume ($0.5 million), and a reduction in
amortization expenses ($0.4 million).
44
Gross profit. Gross profit was $88.0 million for the year ended December 31, 2015 compared to $109.7 million for the year
ended December 31, 2014, representing a decrease of $21.6 million, or 19.7%. The decrease was a combination of the effect of lower
U.S. revenues combined with an increase in the cost of revenues ($23.0 million), offset by an increase in gross profit on sales to
former subsidiaries that are classified in continuing operations ($1.4 million).
Gross margin. Gross margin, excluding intercompany revenue of $10.5 million and $9.1 million for the years ended December
31, 2016 and 2015, respectively, was 67.7% for the year ended December 31, 2015 compared to 73.4 % for the year ended
December 31, 2014. The decrease of 5.7 percentage points was due to increased cost of revenues resulting from one-time charges (3.9
percentage points), unfavorable variation in pricing and product mix (1.2 percentage points), increased royalty costs due to a change in
product mix (0.6 percentage points) and an increase in instrument depreciation expense (0.5 percentage points), offset by a decrease in
inventory reserves and adjustments (0.3 percentage points) and a decrease in amortization expense (0.2 percentage points).
Research and development. Research and development expense was $17.6 million for the year ended December 31, 2015
compared to $16.6 million for the year ended December 31, 2014 representing an increase of $1.0 million, or 6.2%. The increase was
primarily due to an increase in stock-based compensation based on a mark-to-market calculation of stock previously provided to
outside consultants ($2.9 million), offset by a reduction in personnel costs ($1.5 million) and a reduction related to the timing of
development activities and product launch schedules ($0.4 million).
In-process research and development. IPR&D expense was $0.3 million for the year ended December 31, 2015 compared to
$0.5 million for the year ended December 31, 2014. The expense in 2015 and 2014 relates to initial purchase payments in connection
with asset purchase agreements for which the underlying product was not technologically feasible at the time the asset was acquired.
Sales and marketing. Sales and marketing expense was $51.8 million for the year ended December 31, 2015 compared to $55.8
million for the year ended December 31, 2014 representing a decrease of $4.0 million, or 7.1%. The decrease was due primarily to a
reduction in commission expense due to the reduction in revenue ($3.8 million).
General and administrative. General and administrative expense was $28.1 million for the year ended December 31, 2015
compared to $34.0 million for the year ended December 31, 2014, representing a decrease of $5.9 million, or 17.4%. The decrease was
due to a reduction in legal expenses associated with the Orthotec litigation ($4.8 million), a reduction in personnel expense ($0.7
million), and a sales tax refund ($0.4 million).
Amortization of intangible assets. Amortization of intangible assets was $1.2 million for both of the years ended December 31,
2015 and 2014. This expense represents amortization in the period for intangible assets associated with general business assets.
Goodwill and intangible assets impairment. The goodwill and intangible assets impairment of $164.3 million for the year ended
December 31, 2015 is a result of our impairment test performed during the third quarter of 2015 triggered by the decline in our share
price. The impairment charge represents a full write off of our existing goodwill balance ($164.3 million).
Restructuring expenses. Restructuring expenses were $0.6 million for the year ended December 31, 2015. In July 2015, we
announced a restructuring of our manufacturing operations in California in an effort to improve our cost structure. The restructuring
includes a reduction in workforce and closing the California manufacturing facility.
Interest expense. Interest expense was $4.0 million for the year ended December 31, 2015 compared to $3.0 million for the year
ended December 31, 2014, representing a decrease of $1.0 million. Interest expense for the years ended December 31, 2015 and 2014
consisted primarily of interest related to loan agreements and lines of credit and the associated amortization expenses related to debt
issuance costs. The increase was primarily due to higher debt balance during 2015 as compared to 2014.
Other income (expense), net. Other income (expense), net was income of $7.4 million for the year ended December 31, 2015
compared to income of $1.8 million for the year ended December 31, 2014, representing an increase in income of $5.6 million.
The increase was due primarily to a decline in the fair value of common stock warrant liability ($5.4 million).
Income tax (benefit) provision. Income tax (benefit) provision was a benefit of $1.1 million for the year ended December 31,
2015 compared to a provision of $0.4 million for the year ended December 31, 2014. The 2015 income tax benefit from continuing
operations consists primarily of the reversal of deferred tax liabilities associated with tax deductible goodwill, partially offset by state
income taxes. The 2014 income tax provision from continuing operations consists primarily of income tax provisions related to state
income taxes and the tax effect of changes in deferred tax liabilities associated with tax deductible goodwill.
45
Discontinued operations. On July 25, 2016, we entered into the Purchase and Sale Agreement with Globus whereby we agreed
to sell all of our International Business to Globus, including our wholly-owned subsidiaries in Japan, Brazil, Australia, China and
Singapore and substantially all of the assets of our other sales operations in the United Kingdom and Italy, and on September 1, 2016,
we completed the sale to Globus. As a result of our strategic decision to sell the International Business and focus on the U.S market,
our consolidated statements of operations and the consolidated balance sheets reflect the financial results from the International
Business as discontinued operations for all periods presented.
For the years ended December 31, 2016, 2015 and 2014, activity presented under discontinued operations in the consolidated
statements of operations represents our commercial operations the prior to the sale of the International Business in September 2016
including certain intercompany sales transactions as the Company will have continuing involvement due to future sales to Globus
under the Supply Agreement. Certain operating expenses were also allocated to the business activities associated with the discontinued
operations as well as interest expense related to our debt that we repaid using the proceeds from the sale of the International Business.
Non-GAAP Financial Measures
We utilize certain financial measures that are not calculated based on U.S. Generally Accepted Accounting Principles, or
GAAP. Certain of these financial measures are considered “non-GAAP” financial measures within the meaning of Item 10 of
Regulation S-K promulgated by the SEC. We believe that non-GAAP financial measures reflect an additional way of viewing aspects
of our operations that, when viewed with the GAAP results, provide a more complete understanding of our results of operations and
the factors and trends affecting our business. These unaudited non-GAAP financial measures are also used by our management to
evaluate financial results and to plan and forecast future periods. However, non-GAAP financial measures should be considered as a
supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Non-
GAAP financial measures used by us may differ from the non-GAAP measures used by other companies, including our competitors.
Adjusted EBITDA represents net income (loss) excluding the effects of interest, taxes, depreciation, amortization, stock-based
compensation and other non-recurring income or expense items, such as in-process research and development expense and acquisition
related transaction expenses, restructuring expenses, litigation exposure expenses, trial related legal costs and litigation settlement
expenses. We believe that the most directly comparable GAAP financial measure to adjusted EBITDA is net income (loss). Adjusted
EBITDA has limitations, however, and therefore, should not be considered either in isolation or as a substitute for analysis of our
results as reported under GAAP. Furthermore, adjusted EBITDA should not be considered as an alternative to operating income (loss)
or net income (loss) as a measure of operating performance or to net cash provided by operating, investing or financing activities, or as
a measure of our ability to meet cash needs.
The following is a reconciliation of adjusted EBITDA to the most comparable GAAP measure, net loss, for the years ended
December 31, 2016, 2015 and 2014 (in thousands):
Net loss
Stock-based compensation
Depreciation
Amortization of intangible assets
Goodwill and intangible assets impairment
In-process research and development
Stock price guarantee
Interest expense, net
Loss on debt extinguishment
Income tax (benefit) provision
Other (income) expense, net
Restructuring and other expenses
Net loss from discontinued operations
Litigation expenses and trial costs
Adjusted EBITDA
Year Ended December 31,
2015
(178,676) $
2,567
10,802
2,968
164,263
274
4,878
3,990
—
(1,146)
(7,445)
597
7,423
—
10,495 $
2016
(29,925) $
1,626
7,387
1,608
1,736
—
1,815
5,365
9,478
(4,634)
715
2,292
3,624
—
1,087 $
2014
(12,882)
4,404
9,542
2,248
—
527
—
3,012
—
407
(1,836)
36
12,784
4,779
23,021
$
$
46
Liquidity and Capital Resources
We have incurred significant net losses since inception and relied on our ability to fund our operations through revenues from
the sale of our products, equity financings and debt financings. As we have incurred losses, a successful transition to profitability is
dependent upon achieving a level of revenues adequate to support our cost structure. This may not occur and, unless and until it does,
we will continue to need to raise additional capital. At December 31, 2016, our principal sources of liquidity consisted of cash of
$19.6 million and accounts receivable, net of $18.5 million. Together with the proceeds of our $18.9 million private placement in
March 2017, we currently estimate this will provide sufficient capital to fund our operations through at least the next 12 months.
Historically, our principal sources of cash have included customer payments from the sale of our products, proceeds from the
issuance of common and preferred stock and proceeds from the issuance of debt. Our principal uses of cash have included cash used in
operations, payments relating to purchases of surgical instruments, repayments of borrowings under the Amended Credit Facility,
payments due under the Orthotec settlement agreement and acquisitions of businesses and intellectual property rights. We expect that
our principal uses of cash in the future will be these same uses of cash. We expect that, as our revenues grow, our sales and marketing,
research and development expenses and our capital expenditures will continue to grow and, as a result, we will need to generate
significant net revenues to achieve profitability. Operating losses and negative cash flows may continue for at least the next year as
we continue to incur costs related to the execution of our operating plan and introduction of new products.
We may seek additional funds from public and private equity or debt financings, borrowings under new or existing debt
facilities or other sources to fund our projected operating requirements. However, there is no guarantee that we will be able to obtain
further financing, or do so on reasonable terms. If we are unable to raise additional funds on a timely basis, or at all, we would be
materially adversely affected.
On July 6, 2015, we announced a restructuring of our manufacturing operations in California in an effort to improve our cost
structure. The restructuring included a reduction in workforce and closing our California manufacturing facility. This restructuring
was substantially completed in 2016.
On July 25, 2016, we entered into the Purchase and Sale Agreement, with Globus, pursuant to which, and on the terms and
subject to the conditions thereof, among other things, Globus agreed to acquire our International Business. Upon the closing, of the
Globus Transaction on September 1, 2016, or the Closing, Globus paid us $80 million in cash, subject to a working capital adjustment,
or the Closing Payment. Following the Closing, we have used approximately $66 million of the Closing Payment to (i) repay in full all
amounts outstanding and due under our credit facility with Deerfield and (ii) repay certain of our outstanding indebtedness under our
Amended Credit Facility with MidCap, in each case, including debt-related costs. At the Closing, we also entered into the Globus
Facility Agreement pursuant to which Globus agreed to loan us up to $30 million, of which $25 million was drawn at the Closing and
an additional $5 million draw in the fourth quarter of 2016, subject to the terms and conditions set forth in the Globus Facility
Agreement.
Following the Globus Transaction, the Company reduced its U.S. workforce by approximately 20%. Our chief executive
officer, chief financial officer and SVP, Global Human Resources also departed the Company at that time. As a result of this
workforce reduction and such departures, the Company incurred restructuring charges, of approximately $1.9 million, in connection
with one-time employee termination costs, including severance and other benefits.
A substantial portion of our available cash funds is held in business accounts with reputable financial institutions. At times,
however, our deposits, may exceed federally insured limits and thus we may face losses in the event of insolvency of any of the
financial institutions where our funds are deposited. We did not hold any marketable securities as of December 31, 2016.
Amended Credit Facility and Other Debt
On August 30, 2013, we entered into the Amended Credit Facility, which amended and restated the prior credit facility that we
had with MidCap. On September 1, 2016, we entered into a Fifth Amendment to the MidCap Amended Facility Agreement, or the
MidCap Fifth Amendment, that: (a) permitted (i) the Globus Transaction, (ii) the release of Alphatec International LLC and Alphatec
Pacific, Inc. as credit parties, (iii) the payment in full of all obligations to Deerfield under the Facility Agreement between us and
Deerfield, dated as of March 17, 2014, as amended to date, or the Deerfield Facility Agreement, and (iv) the incurrence of debt under
the Globus Facility Agreement and the granting of liens in favor of Globus, (b) reduced the revolving credit commitment to $22.5
million and the term loan commitment to $5 million, (c) revised the existing financial covenant package, and (d) extended the
commitment expiry date from December 31, 2016 to December 31, 2019. In connection with the prepayment of the term loan under
the Amended Credit Facility, we incurred a prepayment fee of $0.6 million payable to MidCap.
47
The term loan interest rate is priced at the London Interbank Offered Rate, or LIBOR, plus 8.0%, subject to a 9.5% floor, and
the revolving line of credit interest rate remains priced at LIBOR plus 6.0%, reset monthly. At December 31, 2016, the revolving line
of credit carried an interest rate of 6.6% and the term loan carries an interest rate of 9.5%. The borrowing base is determined, from
time to time, based on the value of domestic eligible accounts receivable and domestic eligible inventory. As collateral for the
Amended Credit Facility, we granted MidCap a security interest in substantially all of its assets, including all accounts receivable and
all securities evidencing its interests in our subsidiaries. In addition to monthly payments of interest, monthly repayments of $0.2
million in 2017 and $0.3 million in 2018 through maturity are due, with the remaining principal due upon maturity.
The Amended Credit Facility includes traditional lending and reporting covenants including a liquidity calculation and a fixed
charge coverage ratio to be maintained by us. The Amended Credit Facility also includes several event of default provisions, such as
payment default, insolvency conditions and a material adverse effect clause, which could cause interest to be charged at a rate which is
up to five percentage points above the rate effective immediately before the event of default or result in MidCap’s right to declare all
outstanding obligations immediately due and payable.
On March 11, 2016, we entered into a Third Amendment and Waiver to the Amended Credit Facility with MidCap, or the Third
Amendment to the Amended Credit Facility. The Third Amendment to the Amended Credit Facility extended the maturity date of the
Amended Credit Facility from August 30, 2016 to December 31, 2016 and contains an amendment fee in the amount of $0.5 million,
which is due and payable at the earlier of the termination of the Amended Credit Facility or the maturity date. The Third Amendment
to the Amended Credit Facility also contains a waiver of the December 2015 defaults under the Facility Agreement, provides a waiver
for the fixed charge coverage ratio for January 2016 and eliminates the fixed charge coverage ratio covenant for February 2016. At
December 31, 2016, $1.9 million remains as unamortized debt discount related to the Amended Credit Facility and the prior credit
facility with MidCap within the unaudited consolidated balance sheet, which will be amortized over the remaining term of the
Amended Credit Facility.
On August 8, 2016, we entered into a Fourth Amendment to the Amended Credit Facility with MidCap, or the Fourth
Amendment to the Amended Credit Facility. The Fourth Amendment to the Amended Credit Facility provided for a $2.2 million
increase to the borrowing base until September 15, 2016, and includes an amendment fee of $0.2 million, which was due and paid on
August 8, 2016. The Fourth Amendment to the Amended Credit Facility also contains a waiver for the May and June 2016 non-
compliances.
On March 17, 2014, we entered into the Deerfield Facility Agreement, pursuant to which Deerfield agreed to loan us up to $50
million, subject to the terms and conditions set forth in the Deerfield Facility Agreement. Under the terms of the Deerfield Facility
Agreement, we had the option, but were not required, upon certain conditions to draw the entire amount available under the Deerfield
Facility Agreement, at any time until January 30, 2015, provided that the initial draw be used for a portion of the payments made in
connection with the Orthotec settlement described above, or the Litigation Satisfaction. Following such initial draw down, we had the
opportunity to draw down additional amounts under the Deerfield Facility Agreement up to an aggregate of $15.0 million for working
capital or general corporate purposes. We agreed to pay Deerfield, upon each disbursement of funds under the Deerfield Facility
Agreement, a transaction fee equal to 2.5% of the principal amount of the funds disbursed in addition to the issuance of additional
warrants to purchase up to 833,333 shares of our common stock to Deerfield. In connection with the execution of the Deerfield
Facility Agreement, we issued to Deerfield warrants to purchase an aggregate of 520,833 shares of our common stock, or the Initial
Warrants. Additionally, we agreed that upon each disbursement under the Deerfield Facility Agreement we would issue to Deerfield
warrants to purchase up to 833,333 shares of our common stock, in proportion to the amount of draw compared to the total $50
million facility, or the Draw Warrants.
In March 2014, we drew $26 million under the Deerfield Facility Agreement and received net proceeds of $25.4 million to fund
a portion of the Orthotec settlement payment obligations. In November 2014, we drew an additional $6 million under the Deerfield
Facility Agreement and received net proceeds of $5.9 million to fund additional Orthotec settlement payment obligations. The $0.7
million in transaction fees were recorded as a debt discount and were being amortized over the term of the draw. In connection with
this borrowing, we issued Draw Warrants to purchase 433,333 shares of common stock, which were valued at $5.6 million and
recorded as a debt discount and were being amortized over the term of the draw.
On February 5, 2016, we entered into a Limited Waiver and Second Amendment to the Deerfield Facility Agreement, or the
Deerfield Facility Agreement Second Amendment. The Deerfield Facility Agreement Second Amendment increased the interest rate
under the Deerfield Facility Agreement from 8.75% per annum to 14.75% per annum. In addition, under the Deerfield Facility
Agreement Second Amendment we had an option to elect to have (i) until August 30, 2016, six percent (6%), and (ii) thereafter, three
percent (3%), in each case, of the interest on the outstanding principal amount under the Deerfield Facility Agreement paid in kind,
which would be added to the outstanding principal amount under the Deerfield Facility Agreement and bear interest at the interest rate
of 14.75% per annum, hereinafter referred to as the PIK Interest. All accrued and unpaid PIK Interest was due and payable when the
outstanding amounts under the Deerfield Facility Agreement were due and payable thereunder or were fully repaid, whichever would
occur first. The Deerfield Facility Agreement Second Amendment also contained an amendment fee in the amount of $0.6 million,
48
which was due and payable in installments of $0.2 million in March 2017, March 2018 and March 2019 on the third, fourth and fifth
anniversaries of the Deerfield Facility Agreement; provided, that all unpaid amendment fees shall be due and payable when the
outstanding amounts under the Deerfield Facility Agreement were due and payable or were fully repaid, whichever occurs first. The
Deerfield Facility Agreement Second Amendment also changed the prior date of March 31, 2017 to March 31, 2018, as the date
through which we were obligated to pay interest in the event we prepay amounts outstanding under the Deerfield Facility Agreement
prior to such date. The Deerfield Facility Agreement Second Amendment also contained the waivers of the defaults under the
Deerfield Facility Agreement for the fixed charge coverage ratio through March 2016, but not for the default under the senior leverage
ratio or total leverage ratio financial covenants.
As of December 31, 2016, Orthotec settlement payments of $27.4 million have been made. Additionally, an Orthotec settlement
payment of $1.1 million was made on January 1, 2017. As of December 31, 2016, there remains aggregate of $30.4 million of
Orthotec settlement payments to be paid by us.
In September 2016, in connection with the Globus Transaction, Deerfield exercised its right to convert all outstanding Initial
Warrants and Draw Warrants into shares of our common stock based on the Black-Scholes value of the warrants. The outstanding
warrants were converted into 268,614 shares of our common stock. Prior to the conversion, the outstanding warrants were periodically
revalued to their fair value, included in other income/expense. The change in the fair value of the warrants resulted in an expense of
$0.4 million and a gain of $8.0 million for the years ended December 31, 2016 and 2015, respectively, which is included in other non-
cash items in the consolidated statements of cash flows.
On September 1, 2016, in connection with the Globus Transaction, we repaid in full all amounts outstanding and due under the
Deerfield Facility Agreement and terminated the Deerfield Facility Agreement. Pursuant to the Globus Facility Agreement and the
MidCap Fifth Amendment, we made a final payment of $33.5 million to Deerfield, consisting of outstanding principal and accrued
interest of $27.9 million, a prepayment premium of $5.6 million and other related fees and expenses and wrote-off $3.9 million of
unamortized expenses resulting in a loss on debt extinguishment of $9.5 million, which is included other income (expense) for the
years ended December 31, 2016 and 2015. The interest expense historically incurred in connection with the Deerfield Facility of $4.0
million and $4.7 million for the years ended December 31, 2016 and 2015, respectively, is included in the loss from discontinued
operations to the extent these debt facilities were repaid using the proceeds from the Globus transaction.
On September 1, 2016, we entered into the Globus Facility Agreement, pursuant to which Globus agreed to loan us up to $30
million, subject to the terms and conditions set forth in the Globus Facility Agreement. We made an initial draw of $25 million under
the Globus Facility Agreement and a subsequent draw of $5 million. The remaining amount may be advanced in up to two additional
draws, each in an aggregate amount of no less than $2 million, as requested by us at any time prior to December 31, 2017. As of
December 31, 2016, the outstanding balance under the Globus Facility Agreement was $30.0 million, which becomes due and payable
in quarterly payments of $0.8 million starting November 2018 and the final payment due on September 30, 2021. The term loan
interest rate is priced at LIBOR plus 8.0% through September 1, 2018, and LIBOR plus 13.0%, thereafter.
As collateral for the Globus Facility Agreement, we granted Globus a first lien security interest in substantially all of our assets,
other than accounts receivable and related assets, which will secure the Globus Facility Agreement on a second lien basis. The Globus
Facility Agreement includes traditional lending and reporting covenants including a liquidity calculation and a fixed charge coverage
ratio to be maintained by us that are consistent with the covenants under the Amended Credit Facility. The financial covenants of the
Globus Facility Agreement are not effective until April 2017. There is no assurance that we will be in compliance with the financial
covenants of the Globus Facility Agreement in the future. The Globus Facility Agreement also includes several event of default
provisions, such as payment default, insolvency conditions and a material adverse effect clause, which could cause interest to be
charged at a rate which is up to five percentage points above the rate effective immediately before the event of default or result in
Globus’s right to declare all outstanding obligations immediately due and payable.
We have various capital lease arrangements. The leases bear interest at rates ranging from 6.6% to 9.6%, are generally due in
monthly principal and interest installments, are collateralized by the related equipment, and have various maturity dates through
September 2018. As of December 31, 2016, the balance of these capital leases, net of interest totaled $0.7 million.
49
Operating Activities
We used net cash of $10.0 million from operating activities for the year ended December 31, 2016. During this period, net cash
used by operating activities primarily consisted of a net loss of $29.9 million and working capital and other assets used cash of $2.5
million, which were offset by $22.5 million of non-cash costs including amortization, depreciation, gain on sale of business, loss on
extinguishment of debt, deferred income taxes, stock-based compensation, provision for doubtful accounts, provision for excess and
obsolete inventory, and interest expense related to amortization of debt discount and issuance costs. Working capital and other assets
used cash of $2.6 million primarily consisted of an increase in inventories of $5.7 million and a decrease in accounts payable of $4.9
million and accrued expenses and other of $3.5 million, partially offset by a decrease accounts receivable of $8.0 million, restricted
cash of $2.4 million, prepaid expenses and other current assets of $1.3 million. The decrease in accounts receivable is primarily due to
the sale of the International Business to Globus. The decrease in accounts payable is primarily due to use of the cash proceeds from
the Globus Transaction to pay down payables.
Investing Activities
We provided cash of $62.0 million in investing activities for the year ended December 31, 2016, primarily due to the $69.8
million of net proceeds we received from the sale of our International Business and cash from the sale of assets of $1.3 million. We
used $8.9 million of cash primarily for the purchase of surgical instruments.
Financing Activities
Financing activities used net cash of $43.4 million for the year ended December 31, 2016. Under the Amended Credit Facility
with MidCap, we made net principal payments totaling $16.3 million during the year ended December 31, 2016. We made principal
payments on notes payable and capital leases totaling $54.4 million in the year ended December 31, 2016 for the payoff of the
Deerfield Facility and substantially all of the term debt with Midcap. We received proceeds from notes payable of $30 million from
the Globus Facility Agreement.
Contractual obligations and commercial commitments
Total contractual obligations and commercial commitments as of December 31, 2016 are summarized in the following table (in
thousands):
Amended Credit Facility with MidCap
Facility Agreement with Globus
Interest expense
Note payable for insurance premiums
Capital lease obligations
Operating lease obligations
Litigation settlement obligations
Guaranteed minimum royalty obligations
Stock price guarantee (1)
New product development milestones (2)
Total
Payment Due by Year
2019
2020
2021
— $
Total
$ 17,873 $
30,000
19,347
1,395
505
7,246
30,433
9,397
6,704
400
Thereafter
—
—
—
—
—
—
8,833
2,134
—
—
$123,300 $ 18,677 $ 19,088 $ 31,063 $ 13,921 $ 29,584 $ 10,967
2018
2,379 $ 13,094 $
3,333
1,667
5,223
4,573
—
—
—
68
1,544
1,557
4,400
4,400
1,231
2,006
2,238
2,238
—
200
— $
3,333 21,667
2,028
3,460
—
—
—
—
971
1,585
4,000
4,400
918
943
—
—
—
200
2017
2,400 $
—
4,063
1,395
437
1,589
4,400
2,165
2,228
—
(1) Based on our closing stock price as of December 30, 2016, the last trading date of the fiscal year, of $3.21 per share. Pursuant
to a three-year collaboration agreement, we agreed to make three annual payments to the collaborator as sole consideration for
services provided, paid in our common stock at a per share price of $23.35, which was equal to the average NASDAQ closing
price of the common stock on the five days leading up to and including the date of signing the collaboration agreement. The
actual number of shares issued each year will be determined by the fair market value of the services provided over the prior 12
months. The actual amount of cash settlement will vary depending on the price of our common stock at the respective settlement
dates.
(2)
This commitment represents payments in cash, and is subject to attaining certain sales milestones, development milestones such
as FDA approval, product design and functionality testing requirements, which we believe are reasonably likely to be achieved
during the period from 2018 through 2020.
50
Real Property Leases
In February 2008, we entered into a sublease agreement, or the Sublease, for office, engineering, and research and development
space in Carlsbad, California. The Sublease term commenced May 2008 and ended on January 31, 2016. In January 2016, we entered
into a new lease agreement, or the Building Lease, for the same property with the lease term through July 31, 2021. Under the original
Sublease agreement, we were obligated to pay base rent and certain operating costs and taxes. Monthly base rent payable by us was
approximately $80,500 during the first year of the Sublease, increasing annually at a fixed annual rate of 2.5% to approximately
$93,500 per month in the final year of the Sublease. Our rent was abated for months one through seven of the Sublease. Under the
Sublease, we were required to provide the sublessor with a security deposit in the amount of approximately $93,500. Under the new
Building Lease our monthly rent payable is approximately $105,000 per month during the first year and increases by approximately
$3,000 each year thereafter.
Off-Balance Sheet Arrangements
As of December 31, 2016, we did not have any off-balance sheet arrangements.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based upon our consolidated financial
statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of
these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities,
revenues, expenses and related disclosures. On an on-going basis, we evaluate our estimates and assumptions, including those related
to revenue recognition, allowances for accounts receivable, inventories, goodwill and intangible assets, stock-based compensation and
income taxes. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable
under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities
that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions conditions.
We believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our
consolidated financial statements.
Revenue Recognition
We recognize revenue when all four of the following criteria are met: (i) persuasive evidence that an arrangement exists;
(ii) delivery of the products and/or services has occurred; (iii) the selling price is fixed or determinable; and (iv) collectability is
reasonably assured. In addition, we account for revenue under provisions which set forth guidelines for the timing of revenue
recognition based upon factors such as passage of title, installation, payment and customer acceptance. Determination of criteria
(iii) and (iv) are based on management’s judgment regarding the fixed nature of the fee charged for products delivered and the
collectability of those fees. Specifically, our revenue from sales of spinal and other surgical implants is recognized upon receipt of
written acknowledgment that the product has been used in a surgical procedure or upon shipment to third-party customers who
immediately accept title to such implant. Should changes in conditions cause management to determine these criteria are not met for
certain future transactions, revenues recognized for any reporting period could be adversely impacted.
The application of the multiple element guidance requires subjective determinations, and requires us to make judgments about
the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship.
Deliverables are considered separate units of accounting provided that: (1) the delivered items has value to the customer on a stand-
alone basis and (2) if the arrangement includes a general right of return relative to the delivered items, delivery or performance of the
undelivered items is considered probable and substantially in our control. In determining the units of accounting, we evaluate certain
criteria, including whether the deliverables have stand-alone value, based on the consideration of the relevant facts and circumstances
for each arrangement. In addition, we consider whether the buyer can use the other deliverables for their intended purpose without the
receipt of the remaining elements, whether the value of the deliverable is dependent on the undelivered items, and whether there are
other vendors that can provide the undelivered elements.
Revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including
whether the delivered element has stand-alone value to the customer. The consideration received is allocated among the separate units
based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units.
Arrangement consideration that is fixed or determinable is allocated among the separate units of accounting using the relative selling
price method, and the applicable revenue recognition criteria are applied to each of the separate units of accounting in determining the
appropriate period or pattern of recognition. We determine the estimated selling price for deliverables within each agreement using
vendor-specific objective evidence (VSOE) of selling price, if available, third-party evidence (TPE) of selling price if VSOE is not
available, or management's best estimate of selling price (BESP) if neither VSOE nor TPE is available. Determining the BESP for a
unit of accounting requires significant judgment. In developing the BESP for a unit of accounting, we consider applicable market
conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the
customer and estimated costs.
51
Inventories
Inventories are stated at the lower of cost or market, with cost primarily determined under the first-in, first-out method. We
review the components of inventory on a periodic basis for excess, obsolete and impaired inventory, and record a reserve for the
identified items. We calculate an inventory reserve for estimated excess and obsolete inventory based upon historical turnover and
assumptions about future demand for our products and market conditions. Our biologics product inventories are subject to demand
fluctuations based on the availability and demand for alternative implant products. Our estimates and assumptions for excess and
obsolete inventory are subject to uncertainty as we are continually reviewing our existing products and introducing new products.
Increases in the reserve for excess and obsolete inventory result in a corresponding increase to cost of revenues and establish a new
cost basis for the inventory component.
Valuation of Goodwill and Intangible Assets
We assess the impairment of our goodwill and intangible assets annually in December or whenever business conditions change
and an earlier impairment indicator arises. This assessment requires us to make assumptions and judgments regarding the carrying
value of these assets. These assets are considered to be impaired if we determine that their carrying value may not be recoverable
based upon our assessment of certain events or changes in circumstances, including the following:
•
•
•
•
a determination that the carrying value of such assets cannot be recovered through undiscounted cash flows;
loss of legal ownership or title to the assets;
significant changes in our strategic business objectives and utilization of the assets; or
the impact of significant negative industry or economic trends.
If the assets are considered to be impaired, the impairment we recognize is the amount by which the carrying value of the assets
exceeds the fair value of the assets. In the third quarter of 2015, the market value of our common stock substantially declined. This
decline was considered to be a triggering indicator of potential impairment of our goodwill, and a goodwill impairment test was
performed. We analyzed the carrying amount of goodwill for impairment under a two-part test in accordance with authoritative
guidance.
We estimate the fair value in step one of the goodwill impairment test based on a combination of the income approach which
includes discounted cash flows as well as a market approach that utilizes the market information. The fair value measurements
utilized to perform the impairment analysis are categorized within Level 3 of the fair value hierarchy. The discounted cash flow
projections require management judgment with respect to forecasted sales, launch of new products, gross margins, selling, general and
administrative expenses, capital expenditures and the selection and use of an appropriate discount rate and terminal growth rate. For
purposes of calculating the discounted cash flows, in the third quarter of 2015 we used estimated revenue growth rates
between 3% and 13% for the discrete forecast period. Cash flows beyond the discrete forecast period were estimated using a terminal
value calculation, which incorporated historical and forecasted financial trends and considered long-term earnings growth rates for
publicly traded peer companies. Future cash flows were then discounted to present value at a discount rate of 13.5%, and terminal
value growth rate of 3%. Our market capitalization is also considered in assessing the reasonableness of the Company’s fair value as
determined in step one of the goodwill impairment test. Our assessment resulted in a fair value that was lower than the Company’s
carrying value of net assets.
Based on the result of step one of the impairment test, we determined that our goodwill was impaired and step two of the test
was performed to measure the amount of goodwill impairment. As a result of step two, in the third quarter of 2015 we recorded a
goodwill impairment charge of $164.3 million, representing the write-off of the remaining balance of goodwill.
Significant management judgment is required in the forecast of future operating results that are used in our impairment analysis.
The estimates we used are consistent with the plans and estimates that we use to manage our business. Significant assumptions utilized
in our income approach model included the growth rate of sales for recently introduced products and the introduction of anticipated
new products similar to our historical growth rates. Another important assumption involved in forecasted sales is the projected mix of
higher margin U.S. based sales and lower margin non-U.S. based sales. Additionally, we have projected an improvement in our gross
margin similar to our historical improvements in gross margins, as a result of forecasted mix in U.S. sales versus non-U.S. based sales
and lower manufacturing cost per unit based on the increase in forecasted volume to absorb applied overhead over the next 10 years.
Stock-Based Compensation
We account for stock-based compensation under provisions which require that share-based payment transactions with
employees be recognized in the financial statements based on their fair value and recognized as compensation expense over the
vesting period. The amount of expense recognized during the period is affected by subjective assumptions, including: estimates of our
future volatility, the expected term for our stock options, the number of options expected to ultimately vest, and the timing of vesting
for our share-based awards.
52
We use a Black-Scholes option-pricing model to estimate the fair value of our stock option awards. The calculation of the fair
value of the awards using the Black-Scholes option-pricing model is affected by our stock price on the date of grant as well as
assumptions regarding the following:
•
•
•
•
Estimated volatility is a measure of the amount by which our stock price is expected to fluctuate each year during the
expected life of the award. Our estimated volatility through December 31, 2016 was based on our actual historical
volatility. An increase in the estimated volatility would result in an increase to our stock-based compensation expense.
The expected term represents the period of time that awards granted are expected to be outstanding. Our estimated
expected term through December 31, 2016 was calculated using a weighted-average term based on historical exercise
patterns and the term from option grant date to exercise for the options granted within the specified date range. An
increase in the expected term would result in an increase to our stock-based compensation expense.
The risk-free interest rate is based on the yield curve of a zero-coupon U.S. Treasury bond on the date the stock option
award is granted with a maturity equal to the expected term of the stock option award. An increase in the risk-free interest
rate would result in an increase to our stock-based compensation expense.
The assumed dividend yield is based on our expectation of not paying dividends in the foreseeable future.
We use historical data to estimate the number of future stock option forfeitures. Share-based compensation recorded in our
consolidated statement of operations is based on awards expected to ultimately vest and has been reduced for estimated forfeitures.
Our estimated forfeiture rates may differ from our actual forfeitures which would affect the amount of expense recognized during the
period.
We account for stock option grants to non-employees under provisions which require that the fair value of these instruments be
recognized as an expense over the period in which the related services are rendered.
Share-based compensation expense of awards with performance conditions is recognized over the period from the date the
performance condition is determined to be probable of occurring through the time the applicable condition is met. Determining the
likelihood and timing of achieving performance conditions is a subjective judgment made by management which may affect the
amount and timing of expense related to these share-based awards. Share-based compensation is adjusted to reflect the value of
options which ultimately vest as such amounts become known in future periods. As a result of these subjective and forward-looking
estimates, the actual value of our share-based awards could differ significantly from those amounts recorded in our financial
statements.
Stock-based compensation has been classified as follows in the accompanying consolidated statements of operations (in
thousands, except per share data):
Cost of revenues
Research and development
Sales and marketing
General and administrative
Total
Effect on basic and diluted net loss per share
Year Ended December 31,
2015
2014
2016
$
$
$
36 $
438
258
894
1,626 $
(0.19) $
72 $
286
316
1,893
2,567 $
(0.31) $
274
2,080
385
1,665
4,404
(0.54)
Income Taxes
We account for income taxes in accordance with provisions which set forth an asset and liability approach that requires the
recognition of deferred tax assets and deferred tax liabilities for the expected future tax consequences of temporary differences
between the carrying amounts and the tax bases of assets and liabilities. Valuation allowances are established when necessary to
reduce deferred tax assets to the amount that is more likely than not expected to be realized. In making such a determination, a review
of all available positive and negative evidence must be considered, including scheduled reversal of deferred tax liabilities, projected
future taxable income, tax planning strategies, and recent financial performance.
We recognize interest and penalties related to uncertain tax positions as a component of the income tax provision.
53
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board, or FASB, issued new accounting guidance related to revenue
recognition. This new standard replaces all current U.S. GAAP guidance on this topic and eliminates all industry-specific guidance.
The new revenue recognition standard provides a unified model to determine when and how revenue is recognized. The core principle
is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects
the consideration for which the entity expects to be entitled in exchange for those goods or services. This guidance, including all
subsequent clarifications, is effective for our annual and interim reporting periods in fiscal years beginning after December 15, 2017
and can be applied either retrospectively to each period presented or as a cumulative-effect adjustment as of the date of adoption. We
performed a preliminary assessment of the impact of adopting the new standard on the Consolidated Financial Statements and
considered all items outlined in the standard. In assessing the impact, we have outlined all revenue generating activities, mapped
those activities to performance obligations and traced those performance obligations to the standard. We are now assessing what
impact the change in standard will have on those performance obligations. We will continue to evaluate the future impact and method
of adoption of the new standard and related amendments on the Consolidated Financial Statements and related disclosures throughout
2017.
In August 2014, the FASB issued guidance related to disclosures of uncertainties about an entity’s ability to continue as a going
concern. The guidance requires management to evaluate whether there are conditions and events that raise substantial doubt about the
entity’s ability to continue as a going concern within one year after the financial statements are issued. Management will be required
to make this evaluation for both annual and interim reporting periods and will have to make certain disclosures if it concludes that
substantial doubt exists or when its plans alleviate substantial doubt about the entity’s ability to continue as a going concern.
Substantial doubt exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity
will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued. The
guidance is effective for annual periods ending after December 15, 2016 and for interim reporting periods thereafter. We adopted the
standard for the annual reporting period ending December 31, 2016.
In April 2015, the FASB issued guidance, which amends current presentation guidance by requiring that debt issuance costs
related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt
liability, consistent with debt discounts. Prior to the issuance this guidance, debt issuance costs were required to be presented as an
asset in the balance sheet. We adopted the provisions of the new guidance during the interim period ended March 31, 2016 and prior
period amounts have been reclassified to conform to the current period presentation. As of December 31, 2015, $0.4 million of debt
issuance costs were reclassified in the consolidated balance sheet from prepaid expenses and other current assets to current portion of
long-term debt. The adoption of this guidance did not impact our consolidated statement of operations, comprehensive loss or cash
flows.
In July 2015, the FASB issued new accounting guidance, which changes the measurement principle for inventory from the
lower of cost or market to lower of cost and net realizable value for entities that do not measure inventory using the last-in, first-out or
retail inventory method. The guidance also eliminates the requirement for these entities to consider replacement cost or net realizable
value less an approximately normal profit margin when measuring inventory. The guidance is effective for annual periods beginning
after December 15, 2016, and interim periods within those annual periods. We are currently evaluating the impact of adopting this
new accounting standard on our financial statements.
In February 2016, the FASB issued new accounting guidance, which changes several aspects of the accounting for leases,
including the requirement that all leases with durations greater than twelve months to be recognized on the balance sheet. The
guidance is effective for annual periods and interim periods in fiscal years beginning after December 15, 2018. We are currently
evaluating the impact of adopting this new accounting standard on our financial statements.
In March 2016, the FASB issued new accounting guidance, which changes several aspects of the accounting for share-based
payment award transactions, including accounting and cash flow classification for excess tax benefits and deficiencies, forfeitures, and
tax withholding requirements and cash flow classification. The guidance is effective for annual periods and interim periods in fiscal
years beginning after December 15, 2016. We are currently evaluating the impact of adopting this new accounting standard on our
financial statements.
In August 2016, the FASB issued new accounting guidance, which eliminates the diversity in practice related to the
classification of certain cash receipts and payments in the statement of cash flows, by adding or clarifying guidance on eight specific
cash flow issues. The guidance is effective for annual and interim reporting periods beginning after December 15, 2017, with early
adoption permitted. The amendments in this update should be applied retrospectively to all periods presented, unless deemed
impracticable, in which case, prospective application is permitted. We are currently evaluating the new guidance and have not
determined the impact this standards update may have on our financial statements.
54
Item 7A.
Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk
Our borrowings under our line of credit expose us to market risk related to changes in interest rates. As of December 31, 2016,
our outstanding floating rate indebtedness totaled $47.3 million. The primary base interest rate is LIBOR. Assuming the outstanding
balance on our floating rate indebtedness remains constant over a year, a 100 basis point increase in the interest rate would decrease
pre-tax income and cash flow by approximately $0.5 million. Other outstanding debt consists of fixed rate instruments, including
notes payable and capital leases.
Commodity Price Risk
We purchase raw materials that are processed from commodities, such as titanium and stainless steel. These purchases expose us
to fluctuations in commodity prices. Given the historical volatility of certain commodity prices, this exposure can impact our product
costs. However, because our raw material prices comprise a small portion of our cost of revenues, we have not experienced any
material impact on our results of operations from changes in commodity prices. A 10% change in commodity prices would not have a
material impact on our results of operations for the year ended December 31, 2016.
Item 8.
Financial Statements and Supplementary Data
The consolidated financial statements and supplementary data required by this item are set forth at the pages indicated in
Item 15.
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Not applicable.
Item 9A.
Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in the
reports we file or submit pursuant to the Exchange Act, is recorded, processed, summarized and reported within the time periods
specified in the SEC’s rules and forms and is accumulated and communicated to our management, including our Chief Executive
Officer and Principal Financial Officer, or persons performing similar functions, as appropriate, to allow for timely decisions
regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any
controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired
control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls
and procedures.
Under the supervision and with the participation of our management, including our Chief Executive Officer and our Principal
Financial Officer, we carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and
procedures (as such term is defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this
Annual Report on Form 10-K. Based on such evaluation, our Chief Executive Officer and Principal Financial Officer concluded that
our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in reports that we file
or submit under the Exchange Act, is recorded, processed, summarized and reported, within the time periods specified in the SEC’s
rules and forms, and is accumulated and communicated to our management, including our Chief Executive Officer and Principal
Financial Officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management, including our Chief Executive Officer and Principal Financial Officer, is responsible for establishing and
maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f)) and 15d-15(f) under the Exchange Act.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections
of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in
conditions, or that the degree of compliance with the policies or procedures may deteriorate.
55
Our management, including our Chief Executive Officer and Principal Financial Officer, has performed an assessment of our
internal control over financial reporting described in “Internal Control—Integrated Framework” (2013 framework) issued by the
Committee of Sponsoring Organizations of the Treadway Commission. The objective of this assessment was to determine whether our
internal control over financial reporting was effective as of December 31, 2016. Based on this assessment, management concluded
that our internal control over financial reporting was effective as of December 31, 2016.
This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm
regarding internal control over financial reporting. We were not required to have, nor have we, engaged our independent registered
public accounting firm to perform an audit of internal control over financial reporting pursuant to SEC rules that permit us to provide
only management's report in this Annual Report on Form 10-K.
Remediation of Previously Reported Material Weakness
In our Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC on March 15, 2016, we reported
a material weakness in our internal control over financial reporting in which we failed to design effective controls over the release of
inventory cost through cost of goods sold at our significant wholly owned subsidiary. To address the material weakness described
above, during the first quarter of 2016, we designed and implemented new and enhanced compensating controls at the consolidated
level to ensure that the calculation of inventory cost release is accurate and that the appropriate level of review is performed. During
the third quarter of 2016, as part of our transaction to sell our International Business to Globus, we sold the subsidiary where the
respective material weakness previously existed.
We believe that these remediation measures have strengthened our internal control over financial reporting and remediated the
material weakness we had identified.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with our evaluation of such
internal control that occurred during the quarter ended December 31, 2016 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
Item 9B.
Other Information
On March 30, 2017, Alphatec Holdings, Alphatec Spine and Midcap entered into a Sixth Amendment (the “Midcap Sixth
Amendment”) to the Amended Credit Facility with Midcap. The Midcap Sixth Amendment amends the defined time periods during
which we are required to calculate the fixed charge coverage ratio in order to determine our compliance with the applicable covenants
of the Amended Credit Facility with Midcap.
On March 30, 2017, Alphatec Holdings, Alphatec Spine and Globus entered into a First Amendment (the “Globus First
Amendment”) to the Globus Facility Agreement. The Globus First Amendment amends the defined time periods during which we are
required to calculate the fixed charge coverage ratio in order to determine our compliance with the applicable covenants of the Globus
Facility Agreement.
The foregoing descriptions do not purport to be complete and is qualified in its entirety by reference to the Midcap Sixth
Amendment and the Globus First Amendment, copies of which will be filed with the Company’s Quarterly Report on Form 10-Q for
the period ended March 31, 2017.
56
PART III
Item 10.
Directors, Executive Officers and Corporate Governance
The information required by Item 10 of this Annual Report on Form 10-K is incorporated by reference from the discussion
responsive thereto under the captions “Management,” “Corporate Governance Matters,” “Compliance with Section 16(a) of the
Securities Exchange Act of 1934,” and “Code of Conduct and Ethics” in our Proxy Statement for the 2017 Annual Meeting of
Stockholders.
Item 11.
Executive Compensation
The information required by Item 11 of this Annual Report on Form 10-K is incorporated by reference from the discussion
responsive thereto under the captions “Executive Officer and Director Compensation,” “Compensation Discussion and Analysis,”
“Compensation Committee Interlocks and Insider Participation,” “Compensation Committee Report,” and “Compensation Practices
and Policies Relating to Risk Management” in our Proxy Statement for the 2017 Annual Meeting of Stockholders.
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by Item 12 of this Annual Report on Form 10-K is incorporated by reference from the discussion
responsive thereto under the captions “Security Ownership of Certain Beneficial Owners and Management” and “Equity
Compensation Plan Information” and the planned proposal entitled “Adoption of Equity Incentive Plan” in our Proxy Statement for
the 2017 Annual Meeting of Stockholders.
Item 13.
Certain Relationships and Related Transactions, and Director Independence
The information required by Item 13 of this Annual Report on Form 10-K is incorporated by reference from the discussion
responsive thereto under the captions “Certain Relationships and Related Transactions,” “Management” and “Corporate Governance
Matters” in our Proxy Statement for the 2017 Annual Meeting of Stockholders.
Item 14.
Principal Accounting Fees and Services
The information required by Item 14 of this Annual Report on Form 10-K is incorporated by reference from the discussion
responsive thereto under the caption “Independent Public Accountants” in our Proxy Statement for the 2017 Annual Meeting of
Stockholders.
57
Item 15.
Exhibits, Financial Statement Schedules
Item 15 (a) The following documents are filed as part of this Annual Report on Form 10-K:
PART IV
(1) Financial Statements:
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Comprehensive Loss
Consolidated Statements of Stockholders’ (Deficit) Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
(2) Financial Statement Schedules:
Schedule II—Valuation and Qualifying Accounts
Page
F-2
F-3
F-4
F-5
F-6
F-7
F-9
F-36
All other financial statement schedules have been omitted because they are not applicable, not required or the information
required is included in the consolidated financial statements or the notes thereto.
Item 15(a)(3) Exhibits List
The following is a list of exhibits filed as part of this Annual Report on Form 10-K.
Exhibit
Number
Exhibit Description
Filed
with this
Report
2.1
2.2
2.3
3.1
3.2
3.3
4.1
Purchase and Sale Agreement, dated as of July
25, 2016, by and between Alphatec Holdings,
Inc. and Globus Medical Ireland, Ltd.
First Amendment to Purchase and Sale
Agreement, dated as of September 1, 2016, by
and between Alphatec Holdings, Inc. and
Globus Medical Ireland, Ltd.
Second Amendment to Purchase and Sale
Agreement and First Amendment to Product
Manufacture and Supply Agreement, dated as of
February 9, 2017, by and between Alphatec
Holdings, Inc. and Globus Medical Ireland, Ltd.
X
Restated Certificate of Incorporation
Amendment to Restated Certificate of
Incorporation
Restated Bylaws
Form of Common Stock Certificate
58
Incorporated by
Reference herein
from Form or
Schedule
Form 8-K
(Exhibit 2.1)
Form 8-K
(Exhibit 2.1)
Filing
Date
SEC File/
Reg.
Number
07/26/16
000-52024
09/08/16
000-52024
Amendment No. 2 to
Form S-1
(Exhibit 3.2)
Form 8-K
(Exhibit 3.1(B))
Amendment No. 5 to
Form S-1
(Exhibit 3.4)
Form 10-K
(Exhibit 4.1)
04/20/06
333-131609
08/24/16
000-52024
05/26/06
333-131609
03/20/14
333-131609
Incorporated by
Reference herein
from Form or
Schedule
Form 8-K
(Exhibit 10.1)
Form 8-K
(Exhibit 4.1)
Form 10-K
(Exhibit 4.8)
Form 8-K
(Exhibit 4.1)
Filing
Date
SEC File/
Reg.
Number
12/22/09
000-52024
03/31/10
000-52024
03/05/12
000-52024
03/19/14
000-52024
Form 10-K
(Exhibit 10.2)
03/15/16
000-52024
Form 10-Q/A
(Exhibit 10.1)
10/21/15
000-52024
Form 8-K/A
(Exhibit 10.3)
10/21/15
000-52024
Form 10-Q
(Exhibit 10.1)
11/03/15
000-52024
Form 10-Q
(Exhibit 10.3)
11/09/16
000-52024
Exhibit
Number
Exhibit Description
Filed
with this
Report
4.2
4.3
4.4
4.5
10.1
10.2†
10.3†
10.4†
10.5†
10.6†
Corporate Governance Agreement, dated
December 17, 2009, between the Company and
certain shareholders of Scient’x Groupe S.A.S.
and Scient’x S.A.
Registration Rights Agreement, dated March 26,
2010, by and among Alphatec Holdings, Inc.
and the other signatories thereto
Warrant with Silicon Valley Bank as the
Warrantholder, dated December 16, 2011
Form of Warrant to Purchase Common Stock
issued to each of Deerfield Private Design Fund
II, L.P., Deerfield Private Design International
II, L.P., Deerfield Special Situations Fund, L.P.
and Deerfield Special Situations International
Master Fund, L.P. (collectively, “Deerfield”) on
each of March 17, 2014 and November 21,
2014.
Real Property Lease Agreements
Lease Agreement by and between Alphatec
Holdings, Inc. and Fenton Property Company.,
dated as of January 21, 2016
Loan Agreements
Amended and Restated Credit, Security and
Guaranty Agreement dated August 30, 2013 by
and among Alphatec Holdings, Inc., Alphatec
Spine, Inc., Alphatec International LLC,
Alphatec Pacific, Inc. and MidCap Funding IV,
LLC
First Amendment to Amended and Restated
Credit, Security and Guaranty Agreement, dated
March 17, 2014, with MidCap Funding IV, LLC
as Administrative Agent and lender and other
lenders from time to time a party thereto
Second Amendment to the Amended and
Restated Credit, Security and Guaranty
Agreement, dated July 10, 2015, with MidCap
Funding IV Trust, as a lender and other lenders
from time to time a party thereto
Third Amendment to the Amended and Restated
Credit, Security and Guaranty Agreement, dated
March 11, 2016, with MidCap Funding IV Trust,
as a lender and other lenders from time to time a
party thereto
Fourth Amendment to the Amended and
Restated Credit, Security and Guaranty
Agreement, dated August 8, 2016, with MidCap
Funding IV Trust, as a lender and other lenders
from time to time a party thereto
X
59
Exhibit
Number
10.7†
10.8
10.9†
10.10
10.11
10.12
Exhibit Description
Consent and Fifth Amendment to the Amended
and Restated Credit, Security and Guaranty
Agreement, dated September 1, 2016 with
MidCap Funding IV Trust, as a lender and other
lenders from time to time a party thereto
Amended and Restated Term Loan Note, dated
July 10, 2015, with MidCap Funding IV Trust
Facility Agreement, dated March 17, 2014, by
and among Alphatec Holdings, Inc., Deerfield
Private Design Fund II, L.P., Deerfield Private
Design International II, L.P., Deerfield Special
Situations Fund, L.P., and Deerfield Special
Situations International Master Fund, L.P.
First Amendment to the Facility Agreement,
dated July 10, 2015, by and among Alphatec
Holdings, Inc., Deerfield Private Design Fund
II, L.P., Deerfield Private Design International
II, L.P., and Deerfield Special Situations Fund,
L.P.
Limited Waiver and Second Amendment to the
Facility Agreement, dated February 5, 2016, by
and among Alphatec Holdings, Inc., Deerfield
Private Design Fund II, L.P., Deerfield Private
Design International II, L.P., and Deerfield
Special Situations Fund, L.P.
Guaranty and Security Agreement, dated March
17, 2014 by and among Alphatec Holdings, Inc.,
Alphatec Spine, Inc., Alphatec International
LLC, Alphatec Pacific, Inc., Deerfield Private
Design Fund II, L.P., Deerfield Private Design
International II, L.P., Deerfield Special
Situations Fund, L.P., and Deerfield Special
Situations International Master Fund, L.P.
Filed
with this
Report
Incorporated by
Reference herein
from Form or
Schedule
Form 10-Q
(Exhibit 10.3)
Form 10-Q
(Exhibit 10.3)
Form 8-K/A
(Exhibit 10.1)
Filing
Date
SEC File/
Reg.
Number
11/09/16
000-52024
11/03/15
000-52024
10/21/15
000-52024
Form 10-Q
(Exhibit 10.2)
10/03/15
000-52024
Form 10-Q
(Exhibit 10.1)
05/06/16
000-52024
Form 8-K
(Exhibit 10.2)
03/19/14
000-52024
10.13†
Credit, Security and Guaranty Agreement, dated
September 1, 2016 with Globus Medic, Inc.
Form 10-Q
(Exhibit 10.1)
11/09/16
000-52024
Agreements with Respect to Product Supply, Collaborations, Licenses, Research and Development
10.14†
10.15†
10.16†
Supply Agreement by and between Alphatec
Spine, Inc. and Invibio, Inc., dated as of
October 18, 2004 and amended by Letter of
Amendment in respect of the Supply
Agreement, dated as of December 13, 2004
Letter Amendment between Alphatec Spine,
Inc. and Invibio, Inc., dated November 24, 2010
Collaboration Agreement by and among
Alphatec Spine, Inc., Elite Medical Holdings,
LLC and Pac 3 Surgical Products, LLC, dated
as of October 22, 2013
Amendment No. 4 to
Form S-1
(Exhibit 10.29)
05/15/06
333-131609
Form 10-Q
(Exhibit 10.3)
Form 10-K
(Exhibit 10.26)
05/06/11
000-52024
03/20/14
333-18790
60
Exhibit
Number
10.17
10.18†
10.19*
10.20*
10.21*
10.22*
10.23*
10.24*
10.25*
10.26*
10.27*
10.28*
10.29*
10.30*
Exhibit Description
First Amendment to the Collaboration
Agreement by and among Alphatec Spine, Inc.,
Elite Medical Holdings, LLC and Pac 3 Surgical
Products, LLC, dated November 2, 2015
Product Manufacture and Supply Agreement,
dated September 1, 2016 with Globus Medical
Ireland, Ltd.
Agreements with Officers and Directors
Employment Agreement by and among
Alphatec Spine, Inc., Alphatec Holdings, Inc.
and Michael O’Neill, dated October 11, 2010
Michael O’Neill Separation of Employment
Agreement, effective as of September 15, 2016
Employment Agreement, dated February 26,
2012, by and among Alphatec Holdings, Inc.,
Alphatec Spine, Inc, and Leslie Cross
Amendment to the Employment Agreement by
and among Les Cross, Alphatec Holdings, Inc.
and Alphatec Spine, Inc., dated May 1, 2014
Amendment to the Employment Agreement by
and among Les Cross, Alphatec Holdings, Inc.
and Alphatec Spine, Inc., dated September 15,
2016
Amended and Restated Employment Agreement
by and among Alphatec Holdings, Inc.,
Alphatec Spine, Inc. and Ebun S. Garner, Esq.,
dated July 17, 2006
Employment Agreement by and among James
M. Corbett, Alphatec Holdings, Inc. and
Alphatec Spine, Inc., dated April 25, 2014
James M. Corbett Separation of Employment
Agreement, effective as of September 15, 2016
Employment Agreement by and among Michael
Plunkett, Alphatec Spine, Inc., and Alphatec
Holdings, Inc., dated February 17, 2014
Amendment to the Employment Agreement, by
and among Michael Plunkett, Alphatec
Holdings, Inc. and Alphatec Spine, Inc.,
effective as of September 15, 2016
Filed
with this
Report
Incorporated by
Reference herein
from Form or
Schedule
Form 10-K
(Exhibit 10.16)
Filing
Date
SEC File/
Reg.
Number
03/15/16
000-52024
Form 10-Q
(Exhibit 10.2)
11/09/16
000-52024
Form 10-Q
(Exhibit 10.2)
Form 10-Q
(Exhibit 10.7)
Form 10-Q
(Exhibit 10.1)
Form 10-K
(Exhibit 10.23)
Form 10-Q
(Exhibit 10.4)
11/08/10
000-52024
11/09/16
000-52024
05/08/12
000-52024
02/27/15
000-52024
11/09/16
000-52024
Form 10-K
(Exhibit 10.20)
03/07/08
000-52024
Form 10-Q
(Exhibit 10.1)
Form 10-Q
(Exhibit 10.6)
Form 10-Q
(Exhibit 10.4)
Form 10-Q
(Exhibit 10.5)
07/31/14
000-52024
11/09/16
000-52024
05/01/14
000-52024
11/09/16
000-52024
Employment Agreement by and among Terry
Rich, Alphatec Spine, Inc., and Alphatec
Holdings, Inc., dated , 2016
X
Form of Indemnification Agreement entered
into with each of the Company’s non-employee
directors
Form 10-Q
(Exhibit 10.5)
05/05/09
000-52024
61
Incorporated by
Reference herein
from Form or
Schedule
Form 10-K
(Exhibit 10.25)
Form S-8
(Exhibit 99.1)
Schedule 14A
(Appendix B)
Form 10-Q
(Exhibit 10.1)
Form 10-K
(Exhibit 10.40)
Form 10-K
(Exhibit 10.41)
Form 10-K
(Exhibit 10.42)
Form 10-Q
(Exhibit 10.2)
Schedule 14A
(Appendix C)
Form S-8
(Exhibit 10.1)
Form S-8
(Exhibit 10.2)
Form S-8
(Exhibit 10.2)
Form S-8
(Exhibit 10.3)
Form S-8
(Exhibit 10.4)
Form S-8
(Exhibit 10.5)
Filing
Date
SEC File/
Reg.
Number
03/15/16
000-52024
03/23/13
333-187190
06/11/13
000-52024
10/30/14
000-52024
03/05/13
000-52024
03/05/13
000-52024
03/05/14
000-52024
10/30/14
000-52024
06/11/13
000-52024
10/05/16
333-213981
10/05/16
333-213981
12/12/16
333-215036
10/05/16
333-213981
10/05/16
333-213981
10/05/16
333-213981
Exhibit
Number
10.31*
10.32*
10.33*
10.34*
10.35*
10.36*
10.37*
10.38*
10.39*
10.40*
10.41*
10.42*
10.43*
10.44*
10.45*
Exhibit Description
Vesting Acceleration Agreement by and
between James Glynn and Alphatec Holdings,
Inc., dated November 2, 2015
Equity Compensation Plans
Amended and Restated 2005 Employee,
Director and Consultant Stock Plan
Amendment to the Amended and Restated 2005
Employee, Director and Consultant Stock Plan
Amendment to the Alphatec Holdings, Inc.
Amended and Restated 2005 Employee,
Director and Consultant Stock Plan
Form of Non-Qualified Stock Option
Agreement issued under the Amended and
Restated 2005 Stock Plan
Form of Incentive Stock Option Agreement
issued under the Amended and Restated 2005
Stock Plan
Form of Restricted Stock Agreement issued
under the Amended and Restated 2005 Stock
Plan
Form of Performance-Based Restricted Unit
Agreement issued under the Amended and
Restated 2005 Employee, Director and
Consultant Stock Plan, as amended.
Amended and Restated 2007 Employee Stock
Purchase Plan
Alphatec Holdings, Inc. 2016 Equity Incentive
Plan
Alphatec Holdings, Inc. 2016 Employment
Inducement Award Plan
First Amendment to the Alphatec Holdings, Inc.
2016 Employment Inducement Award Plan
Form of Restricted Stock Unit Grant Notice and
Restricted Stock Unit Award Agreement under
the Alphatec Holdings, Inc. 2016 Employment
Inducement Award Plan
Form of Stock Option Grant Notice and Stock
Option Agreement under the Alphatec Holdings,
Inc. 2016 Employment Inducement Award Plan
Form of Performance Stock-Based Award Grant
Notice and Performance Stock-Based Award
Agreement under the Alphatec Holdings, Inc.
2016 Employment Inducement Award Plan
Filed
with this
Report
62
Filed
with this
Report
Incorporated by
Reference herein
from Form or
Schedule
Filing
Date
SEC File/
Reg.
Number
Form 10-Q
(Exhibit 10.3)
10/30/14
000-52024
X
X
X
X
X
Exhibit
Number
10.46
21.1
23.1
31.1
31.2
32
101.1
101.2
101.3
101.4
101.5
101.6
Exhibit Description
Settlement Agreements
Settlement and Release Agreement, dated as of
August 13, 2014, by and among Alphatec
Holdings, Inc. and its direct and indirect
subsidiaries and affiliates, Orthotec, LLC,
Patrick Bertranou and the other parties named
therein
Subsidiaries of the Registrant and Wholly
Owned Subsidiaries of the Registrant's
Subsidiaries
Consent of Independent Registered Public
Accounting Firm
Certification of Principal Executive Officer
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
Certification of Principal Financial Officer
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
Certification pursuant to 18 U.S.C. 1350, as
adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
XBRL Instance Document**
XBRL Taxonomy Extension Schema
Document**
XBRL Taxonomy Extension Calculation
Linkbase Document**
XBRL Taxonomy Extension Definition
Linkbase Document**
XBRL Taxonomy Extension Label Linkbase
Document**
XBRL Taxonomy Extension Presentation
Linkbase Document**
(*) Management contract or compensatory plan or arrangement.
(†) Confidential treatment has been granted by the Securities and Exchange Commission as to certain portions.
(**) Confidential treatment is being requested as to certain portions of this exhibit.
63
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
Dated: March 30, 2017
ALPHATEC HOLDINGS, INC.
By:
Name:
Title:
/S/ TERRY M. RICH
Terry M. Rich
Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons
on behalf of the registrant and in the capacities and on the dates indicated:
Signature
Title
Date
/S/ MORTIMER BERKOWITZ III
Mortimer Berkowitz III
Chairman of the Board of Directors,
March 30, 2017
/S/ TERRY M. RICH
Terry M. Rich
Director and Chief Executive Officer,
(Principal Executive Officer)
March 30, 2017
/S/ DENNIS T. NELSON
Dennis T. Nelson
Vice President, Finance and Controller,
(Principal Financial Officer and Principal Accounting Officer)
March 30, 2017
/S/ LESLIE H.CROSS
Leslie H. Cross
/S/ DAVID R. MOWRY
David R. Mowry
/S/ R. IAN MOLSON
R. Ian Molson
/S/ STEPHEN E. O’NEIL
Stephen E. O’Neil
/S/ DONALD A. WILLIAMS
Donald A. Williams
Director
Director
Director
Director
Director
March 30, 2017
March 30, 2017
March 30, 2017
March 30, 2017
March 30, 2017
64
ALPHATEC HOLDINGS, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Comprehensive Loss
Consolidated Statements of Stockholders’ (Deficit) Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
Page
F-2
F-3
F-4
F-5
F-6
F-7
F-9
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders of
Alphatec Holdings, Inc.
We have audited the accompanying consolidated balance sheets of Alphatec Holdings, Inc. as of December 31, 2016 and 2015,
and the related consolidated statements of operations, comprehensive loss, stockholders’ (deficit) equity, and cash flows for each of
the three years in the period ended December 31, 2016. Our audits also included the financial statement schedule listed in the Index at
Item 15(a)(2). These financial statements and schedule are the responsibility of the Company's management. Our responsibility is to
express an opinion on these financial statements and schedule based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States).
Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are
free of material misstatement. We were not engaged to perform an audit of the Company’s internal control over financial reporting.
Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates
made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable
basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial
position of Alphatec Holdings, Inc. at December 31, 2016 and 2015, and the consolidated results of its operations and its cash flows
for each of the three years in the period ended December 31, 2016, in conformity with U.S. generally accepted accounting principles.
Also, in our opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a
whole, presents fairly in all material respects the information set forth therein.
/s/ Ernst & Young LLP
San Diego, California
March 30, 2017
F-2
ALPHATEC HOLDINGS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except par value data)
December 31,
2016
2015
Assets
Current assets:
Cash
Restricted cash
Accounts receivable, net
Inventories, net
Prepaid expenses and other current assets
Current assets of discontinued operations
Total current assets
Property and equipment, net
Intangibles, net
Other assets
Noncurrent assets of discontinued operations
Total assets
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable
Accrued expenses
Common stock warrant liabilities
Current portion of long-term debt
Current liabilities of discontinued operations
Total current liabilities
Long-term debt, less current portion
Other long-term liabilities
Long-term liabilities of discontinued operations
Redeemable preferred stock, $0.0001 par value; 20,000 authorized at December 31, 2016
and 2015; 3,319 shares issued and outstanding at both December 31, 2016 and 2015
Commitments and contingencies
Stockholders’ deficit:
Common stock, $0.0001 par value; 200,000 authorized; 9,049 and 8,513
shares issued and outstanding at December 31, 2016 and 2015, respectively
Treasury stock, 2 shares
Additional paid-in capital
Shareholder note receivable
Accumulated other comprehensive income (loss)
Accumulated deficit
Total stockholders’ deficit
Total liabilities and stockholders’ deficit
$
$
$
$
$
$
$
19,593
—
18,512
30,093
4,262
364
72,824
15,076
5,711
516
61
94,188
8,701
27,589
—
3,113
732
40,135
43,092
28,862
—
23,603
1
(97)
419,787
(5,000)
970
(457,165)
(41,504)
$
94,188
6,295
2,350
26,870
32,632
3,138
30,210
101,495
16,081
8,806
502
19,457
146,341
13,542
21,175
687
79,742
9,891
125,037
480
32,281
1,516
23,603
1
(97)
416,948
(5,000)
(21,188)
(427,240)
(36,576)
146,341
See accompanying notes to consolidated financial statements.
F-3
ALPHATEC HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
Revenues
Cost of revenues
Gross profit
Operating expenses:
Research and development
In-process research and development
Sales and marketing
General and administrative
Amortization of intangible assets
Goodwill and intangible assets impairment
Restructuring expenses
Total operating expenses
Operating (loss) income
Other income (expense):
Interest income
Interest expense
Loss on debt extinguishment
Other income (expense), net
Total other income (expense)
Income (loss) from continuing operations before taxes
Income tax (benefit) provision
Loss from continuing operations
Loss from discontinued operations, net of applicable taxes
Net loss
Loss per share, basic:
Continuing operations
Discontinued operations
Net loss per share, basic
Net loss per share, diluted:
Continuing operations
Discontinued operations
Net loss per share, diluted
Shares used in calculating basic net loss per share
Shares used in calculating diluted net loss per share
2016
Year Ended December 31,
2015
2014
$
$
120,248
44,114
76,134
$
134,388
46,366
88,022
9,248
—
50,962
26,339
934
1,736
2,292
91,511
(15,377)
3
(5,368)
(9,478)
(715)
(15,558)
(30,935)
(4,634)
(26,301)
(3,624)
(29,925) $
(3.06) $
(0.42)
(3.49) $
(3.06) $
(0.42)
(3.49) $
8,582
8,582
17,615
274
51,801
28,126
1,200
164,263
597
263,876
(175,854)
11
(4,001)
—
7,445
3,455
(172,399)
(1,146)
(171,253)
(7,423)
(178,676) $
(20.64) $
(0.89)
(21.53) $
(20.64) $
(0.89)
(21.53) $
8,298
8,298
$
$
$
$
$
154,625
44,958
109,667
16,593
527
55,782
34,048
1,232
—
—
108,182
1,485
10
(3,022)
—
1,836
(1,176)
309
407
(98)
(12,784)
(12,882)
(0.01)
(1.58)
(1.59)
(0.33)
(1.57)
(1.90)
8,112
8,145
See accompanying notes to consolidated financial statements.
F-4
ALPHATEC HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
Net loss
Foreign currency translation adjustments related to continuing operations
Foreign currency translation realized to discontinued operations
Comprehensive loss
$
$
2016
Year Ended December 31,
2015
(178,676) $
(9,872)
—
(188,548) $
(29,925) $
3,635
18,523
(7,767) $
2014
(12,882)
(15,193)
—
(28,075)
See accompanying notes to consolidated financial statements.
F-5
ALPHATEC HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ (DEFICIT) EQUITY
(In thousands)
Balance at December 31, 2013
Stock-based compensation
Exercise of stock options
Repurchase and/or forfeiture of
common stock
Shares issued for consulting services
Issuance of common stock for employee
stock purchase plan
Issuance of common stock for restricted
share awards granted to employees
Shareholder note receivable
Issuance of common stock for acquired
technology
Foreign currency translation adjustments
Net loss
Balance at December 31, 2014
Stock-based compensation
Exercise of stock options
Repurchase and/or forfeiture of
common stock
Shares issued for consulting services
Issuance of common stock for employee
stock purchase plan
Issuance of common stock for restricted
share awards granted to employees
Issuance of common stock for acquired
technology
Foreign currency translation adjustments
Net loss
Balance at December 31, 2015
Stock-based compensation
Repurchase and/or forfeiture of
common stock
Shares issued for consulting services
Issuance of common stock for employee
stock purchase plan
Warrant conversion
Foreign currency translation adjustments
Net loss
Balance at December 31, 2016
Common stock
Shares Amount capital
paid-in
Treasury
comprehensive Accumulated
stock income (loss)
deficit
Accumulated
other
Additional
Shareholder
note
receivable
— $
—
—
8,133 $
—
2
1 $ 403,577 $
2,690
—
29
—
(22)
111
—
—
(3)
1,864
—
—
(97) $
—
—
—
—
51
—
671
—
—
41
—
—
—
—
5,000
—
(5,000)
6
—
—
8,321
—
—
102
—
—
—
—
—
1 413,930
2,562
—
—
—
—
—
—
(5,000)
—
—
(22)
110
—
—
—
81
—
—
—
—
—
—
—
(97)
—
—
—
—
72
—
375
—
—
24
—
—
—
—
Total
stockholders’
(deficit) equity
171,676
2,690
29
3,877 $ (235,682) $
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
(15,193)
—
(11,316)
—
—
—
—
(12,882)
(248,564)
—
—
—
—
—
—
—
—
—
—
(3)
1,864
671
—
—
102
(15,193)
(12,882)
148,954
2,562
—
—
81
375
—
6
—
—
8,513
—
—
—
—
—
—
—
1 416,948
1,626
—
—
—
—
(5,000)
—
(1)
210
—
—
—
25
—
—
58
269
—
—
9,049 $
114
—
1,074
—
—
—
—
—
1 $ 419,787 $
—
—
—
—
(5,000) $
—
—
—
(97)
—
—
—
—
—
—
—
(97) $
—
(9,872)
—
(21,188)
—
—
—
(178,676)
(427,240)
—
—
(9,872)
(178,676)
(36,576)
1,626
—
—
—
—
—
25
—
—
—
—
—
22,158
—
(29,925)
970 $ (457,165) $
114
1,074
22,158
(29,925)
(41,504)
See accompanying notes to consolidated financial statements.
F-6
ALPHATEC HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Operating activities:
Net loss
Adjustments to reconcile net loss to net cash (used in) provided by
operating activities:
Depreciation and amortization
Goodwill and intangible assets impairment
Stock-based compensation
Interest expense related to amortization of debt discount and debt
issuance costs
In-process research and development
Provision for doubtful accounts
Provision for excess and obsolete inventory
Deferred income tax provision (benefit)
Gain on sale of business
Loss on extinguishment of debt
Other non-cash items
Changes in operating assets and liabilities:
Restricted cash
Accounts receivable
Inventories
Prepaid expenses and other current assets
Other assets
Accounts payable
Accrued expenses and other
Net cash (used in) provided by operating activities
Investing activities:
Purchases of property and equipment
Purchase of intangible assets
Proceeds from sale of business, net
Cash received from sale of assets
Net cash provided by (used in) investing activities
Financing activities:
Issuance of common stock
Borrowings under lines of credit
Repayments under lines of credit
Principal payments on capital lease obligations
Proceeds from issuance of notes payable
Principal payments on notes payable
Net cash (used in) provided by financing activities
Effect of exchange rate changes on cash
Net increase (decrease) in cash
Cash at beginning of year, including discontinued operations
Cash at end of year, including discontinued operations
2016
Year Ended December 31,
2015
2014
$
(29,925) $
(178,676) $
(12,882)
12,364
2,189
1,626
3,630
—
620
5,663
10
(7,935)
3,863
426
2,350
8,000
(5,742)
1,074
191
(4,865)
(3,498)
(9,959)
(8,897)
(250)
69,790
1,316
61,959
114
118,482
(134,792)
(798)
28,046
(54,444)
(43,392)
(85)
8,523
11,229
19,752
$
$
19,031
165,171
2,643
4,695
98
584
2,156
(333)
—
—
(4,363)
4,400
1,197
(5,456)
2,472
(6)
3,209
(6,698)
10,124
(12,247)
—
—
—
(12,247)
375
141,583
(144,567)
(747)
5,000
(8,176)
(6,532)
149
(8,506)
19,735
11,229
$
18,385
—
4,554
6,700
102
522
3,539
251
—
—
1,913
(6,750)
(1,028)
(4,348)
4,863
(276)
(1,042)
(34,774)
(20,271)
(11,300)
—
—
300
(11,000)
26
163,067
(156,106)
(766)
30,350
(5,837)
30,734
(1,073)
(1,610)
21,345
19,735
See accompanying notes to consolidated financial statements.
F-7
ALPHATEC HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS—(Continued)
(in thousands)
Supplemental disclosure of cash flow information:
Cash paid for interest
Cash paid for income taxes
Purchases of property and equipment in accounts payable
Purchase of property and equipment through capital leases
Cashless warrant conversion
Non-cash debt discount
Initial fair value of warrant liability
2016
Year Ended December 31,
2015
2014
$
$
$
$
$
$
$
7,368
920
2,668
—
1,074
—
—
$
$
$
$
$
$
$
7,627
621
2,323
243
—
—
—
$
$
$
$
$
$
$
5,885
565
1,638
1,212
—
650
11,280
See accompanying notes to consolidated financial statements.
F-8
ALPHATEC HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. The Company and Basis of Presentation
The Company
Alphatec Holdings, Inc. (“Alphatec,” “Alphatec Holdings” or the “Company”), through its wholly owned subsidiary, Alphatec
Spine, Inc. and its subsidiaries (“Alphatec Spine”), is a medical technology company focused on the design, development and
promotion of products for the surgical treatment of spine disorders. The Company has a comprehensive product portfolio and pipeline
that addresses the cervical, thoracolumbar and intervertebral regions of the spine and covers a variety of spinal disorders and surgical
procedures. The Company’s principal product offerings are focused on the U.S. market for fusion-based spinal disorder solutions.
Prior to September 1, 2016, the Company marketed its products in the U.S. market and in over 50 international markets through
the distribution channels of Alphatec Spine and its affiliate, Scient’x S.A.S., and its subsidiaries (“Scient’x”), via a direct sales force in
Italy and the United Kingdom and via independent distributors in the rest of Europe, the Middle East and Africa. In South America
and Latin America, the Company conducted its operations through its Brazilian subsidiary, Cibramed Productos Medicos. In Japan,
the Company marketed its products through its subsidiary, Alphatec Pacific, Inc. and its subsidiaries (“Alphatec Pacific”).
On September 1, 2016, the Company completed the sale of its international distribution operations and agreements to Globus
Medical Ireland, Ltd., a subsidiary of Globus Medical, Inc., and its affiliated entities (collectively “Globus”), including the Company’s
wholly-owned subsidiaries in Japan, Brazil, Australia and Singapore and substantially all of the assets of the Company’s other sales
operations in the United Kingdom and Italy (collectively, the “International Business”), pursuant to a purchase and sale agreement,
dated as of July 25, 2016 (as amended, the “Purchase and Sale Agreement”) (the “Globus Transaction”). As a result of the Globus
Transaction, the Company's International Business has been excluded from continuing operations for all periods presented in this
report and is reported as discontinued operations. See Note 4 for additional information on the divestiture of the International
Business. The sale of the international operations represents a strategic shift and has a significant impact on the Company's operations
and financial results.
Basis of Presentation
The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the
United States of America ("GAAP") and include the accounts of Alphatec and Alphatec Spine and its wholly owned subsidiaries. All
intercompany balances and transactions have been eliminated in consolidation. The Company operates in one reportable business
segment.
On August 24, 2016, the Company filed a certificate of amendment to its certificate of incorporation with the Secretary of State
of the state of Delaware to effectuate a 1-for-12 reverse stock split of the Company’s issued and outstanding common stock. The
accompanying consolidated financial statements and notes thereto give retrospective effect to the reverse stock split for all periods
presented. All issued and outstanding common stock, options exercisable for common stock, warrants exercisable for common stock,
restricted stock units, and per share amounts contained in the Company’s consolidated financial statements have been retroactively
adjusted to reflect this reverse stock split for all periods presented.
As a result of the sale of the International Business, the Company has retrospectively revised the consolidated statements of
operations for the years ended December 31, 2016, 2015 and 2014 and the consolidated balance sheets as of December 31, 2016 and
2015, to reflect the financial results from the International Business, and the related assets and liabilities, as discontinued operations.
The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through
revenues from the sale of its products, equity financings and debt financings. As the Company has historically incurred losses,
successful transition to profitability is dependent upon achieving a level of revenues adequate to support the Company’s cost structure.
This may not occur and, unless and until it does, the Company will continue to need to raise additional capital. Operating losses and
negative cash flows may continue for at least the next year as the Company continues to incur costs related to the execution of its
operating plan and introduction of new products.
For the year ended December 31, 2016, the Company has adopted, as required, FASB Accounting Standard Codification (ASC)
Topic 205-40, Presentation of Financial Statements – Going Concern, which requires that management evaluate whether there are
relevant conditions and events that in aggregate raise substantial doubt about the entity’s ability to continue as a going concern and to
meet its obligations as they become due within one year from the date that the financial statements are issued.
F-9
The Company’s Board approved annual operating plan projects that its existing working capital at December 31, 2016 of $32.7
million (including cash of $19.6 million), along with the proceeds of the $18.9 million private placement that closed on March 29,
2017 (see Note 15) and the amendments to its debt facilities (see Note 15), allows the Company to fund its operations through one
year subsequent to the date the financial statements are issued.
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going
concern and do not include any adjustments that might result from the outcome of this uncertainty. A going concern basis of
accounting contemplates the recovery of the Company’s assets and the satisfaction of its liabilities in the normal course of business.
2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United
States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and
assumptions include the useful lives of property and equipment; allowances for doubtful accounts and sales returns, the valuation of
share based liabilities, deferred tax assets, fixed assets, inventory, investments, notes receivable and stock-based compensation; and
reserves for employee benefit obligations, restructuring liabilities, income tax uncertainties and other contingencies.
Concentrations of Credit Risk and Significant Customers
Financial instruments, which potentially subject the Company to concentrations of credit risk, consist primarily of cash and
accounts receivable. The Company limits its exposure to credit loss by depositing its cash with established financial institutions. As of
December 31, 2016, a substantial portion of the Company’s available cash funds is held in business accounts. Although the Company
deposits its cash with multiple financial institutions, its deposits, at times, may exceed federally insured limits.
The Company’s customers are primarily hospitals, surgical centers and distributors and no single customer represented greater
than 10 percent of consolidated revenues or accounts receivable for any of the periods presented. Credit to customers is granted based
on an analysis of the customers’ credit worthiness and credit losses have not been significant.
Revenue Recognition
The Company derives its revenues primarily from the sale of spinal surgery implants used in the treatment of spine disorders.
The Company sells its products primarily through its direct sales force and independent distributors. Revenue is recognized when all
four of the following criteria are met: (i) persuasive evidence of an arrangement exists; (ii) delivery of the products and/or services has
occurred; (iii) the selling price is fixed or determinable; and (iv) collectability is reasonably assured. In addition, the Company
accounts for revenue under provisions which set forth guidelines for the timing of revenue recognition based upon factors such as
passage of title, installation, payment and customer acceptance.
The Company’s revenue from sales of spinal and other surgical implant products is recognized upon receipt of written
acknowledgment that the product has been used in a surgical procedure or upon shipment to third-party customers who immediately
accept title to such product.
The application of the multiple element guidance requires subjective determinations, and requires the Company to make
judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual
relationship. Deliverables are considered separate units of accounting provided that: (1) the delivered items has value to the customer
on a stand-alone basis and (2) if the arrangement includes a general right of return relative to the delivered items, delivery or
performance of the undelivered items is considered probable and substantially in the Company's control. In determining the units of
accounting, the Company evaluates certain criteria, including whether the deliverables have stand-alone value, based on the
consideration of the relevant facts and circumstances for each arrangement. In addition, the Company considers whether the buyer can
use the other deliverables for their intended purpose without the receipt of the remaining elements, whether the value of the
deliverable is dependent on the undelivered items, and whether there are other vendors that can provide the undelivered elements.
Revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including
whether the delivered element has stand-alone value to the customer. The consideration received is allocated among the separate units
based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units.
Arrangement consideration that is fixed or determinable is allocated among the separate units of accounting using the relative selling
price method, and the applicable revenue recognition criteria are applied to each of the separate units of accounting in determining the
F-10
appropriate period or pattern of recognition. The Company determines the estimated selling price for deliverables within each
agreement using vendor-specific objective evidence (“VSOE”) of selling price, if available, third-party evidence (“TPE”) of selling
price if VSOE is not available, or management's best estimate of selling price (“BESP”) if neither VSOE nor TPE is available.
Determining the BESP for a unit of accounting requires significant judgment. In developing the BESP for a unit of accounting, the
Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in
negotiating the agreement with the customer and estimated costs.
Restricted Cash
In March and November 2014, the Company borrowed and set aside cash for the payment of a portion of the Orthotec litigation
settlement, which is subject to the terms of the facility agreement that it entered into with Deerfield on March 17, 2014. The Company
classified this cash as restricted, because it may not be used for purposes other than payments of amounts due under the Orthotec
litigation settlement agreement. As of December 31, 2016, the Company had no cash classified as restricted cash.
Accounts Receivable, net
Accounts receivable are presented net of allowance for doubtful accounts. The Company makes judgments as to its ability to
collect outstanding receivables and provides allowances for a portion of receivables when collection becomes doubtful. Provisions are
made based upon a specific review of all significant outstanding invoices and the overall quality and age of those invoices not
specifically reviewed. In determining the provision for invoices not specifically reviewed, the Company analyzes historical collection
experience. If the historical data used to calculate the allowance provided for doubtful accounts does not reflect the Company’s future
ability to collect outstanding receivables or if the financial condition of customers were to deteriorate, resulting in impairment of their
ability to make payments, an increase in the provision for doubtful accounts may be required.
Inventories, net
Inventories are stated at the lower of cost or market, with cost primarily determined under the first-in, first-out method. The
Company reviews the components of inventory on a periodic basis for excess, obsolete and impaired inventory, and records a reserve
for the identified items. The Company calculates an inventory reserve for estimated excess and obsolete inventory based upon
historical turnover and assumptions about future demand for its products and market conditions. The Company’s biologics inventories
have an expiration based on shelf life and are subject to demand fluctuations based on the availability and demand for alternative
implant products. The Company’s estimates and assumptions for excess and obsolete inventory are reviewed and updated on a
quarterly basis. Increases in the reserve for excess and obsolete inventory result in a corresponding increase to cost of revenues and
establish a new cost basis for the part. Approximately $12.9 million and $16.2 million of inventory was held at consigned locations as
of December 31, 2016 and 2015, respectively.
Property and Equipment, net
Property and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation is computed using the
straight-line method over the estimated useful lives of the related assets, generally ranging from three to seven years. Leasehold
improvements and assets acquired under capital leases are amortized over the shorter of their useful lives or the terms of the related
leases.
Goodwill and Other Intangible Assets
The Company accounts for goodwill and other intangible assets in accordance with provisions which require that goodwill and
other identifiable intangible assets with indefinite useful lives be tested for impairment at least annually. The Company tests goodwill
and intangible assets for impairment in December of each year, or more frequently if events and circumstances warrant. These assets
are considered impaired if the Company determines that their carrying values may not be recoverable based on an assessment of
certain events or changes in circumstances. If the assets are considered to be impaired, the Company recognizes the amount by which
the carrying value of the assets exceeds the fair value of the assets as an impairment loss. In the third quarter of 2015, the market value
of the Company’s common stock substantially declined. As a result of this decline, the Company determined that it had an indicator of
impairment of the goodwill, and an interim test of goodwill impairment was performed. The Company analyzed the carrying amount
of goodwill for impairment under a two-part test in accordance with authoritative guidance.
The Company estimated the fair value in step one of the goodwill impairment test based on a combination of the income
approach which included discounted cash flows as well as a market approach that utilized the Company’s market information. The
fair value measurements utilized to perform the impairment analysis are categorized within Level 3 of the fair value hierarchy.
Significant management judgment is required in the forecast of future operating results that are used in the Company’s impairment
analysis. The estimates the Company used were consistent with the plans and estimates that it uses to manage its business. Significant
F-11
assumptions utilized in the Company’s income approach model included the growth rate of sales for recently introduced products and
the introduction of anticipated new products similar to its historical growth rates. Another important assumption involved in forecasted
sales was the projected mix of higher margin U.S. based sales and lower margin non-U.S. based sales. Additionally, the Company
projected an improvement in its gross margin, similar to its historical improvement in gross margins, as a result of its forecasted mix
in U.S. sales versus non-U.S. sales and lower manufacturing cost per unit based on the increase in forecasted volume to absorb applied
overhead over the next ten years.
The Company’s discounted cash flows required management judgment with respect to forecasted sales, launch of new products,
gross margins, selling, general and administrative expenses, capital expenditures and the selection and use of an appropriate discount
rate and terminal growth rate. For purposes of calculating the discounted cash flows, the Company used estimated revenue growth
rates averaging between 3% and 13% for the discrete forecast period. Cash flows beyond the discrete forecast period were estimated
using a terminal value calculation, which incorporated historical and forecasted financial trends and considered long-term earnings
growth rates for publicly traded peer companies. Future cash flows were then discounted to present value at a discount rate of 13.5%,
and terminal value growth rate of 3%. The Company's market capitalization was also considered in assessing the reasonableness of the
Company’s fair value as determined in step one of the goodwill impairment test. The Company’s assessment resulted in a fair value
that was lower than the Company’s carrying value of net assets at September 30, 2015.
Based upon step one of the interim impairment test, the Company determined that its goodwill was impaired and that step two of
the test was required to measure the amount of goodwill impairment. As a result of step two, in the third quarter of 2015 the Company
recorded a charge of $164.3 million, representing the write-off of the entire balance of goodwill. The Company finalized the step two
test in the fourth quarter of 2015, which did not change the amount of the impairment charge.
No additional goodwill was recorded in 2016.
The accounting provisions also require that intangible assets with finite useful lives be amortized over their respective estimated
useful lives and reviewed for indicators of impairment. The Company is amortizing its intangible assets, other than goodwill, on a
straight-line basis over a one to fifteen-year period.
Impairment of Long-Lived Assets
The Company assesses potential impairment to its long-lived assets when there is evidence that events or changes in
circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss is recognized when the
carrying amount of the long-lived assets is not recoverable if it exceeds the sum of the undiscounted cash flows expected to result
from the use and eventual disposition of the asset. Any required impairment loss is measured as the amount by which the carrying
amount of a long-lived asset exceeds its fair value and is recorded as a reduction in the carrying value of the related asset and a charge
to operating results.
Foreign Currency
The Company’s results of operations and cash flows are subject to fluctuations due to changes in foreign currency exchange
rates. As of December 31, 2016, the Company’s primary functional currency is the U.S. dollar, while the functional currency of the
Company’s foreign subsidiaries include the Euro and the Hong Kong Dollar. Prior to the sale of the International Business the
Company’s primary functional currency is the U.S. dollar, while the functional currency of the Company’s foreign subsidiaries
included the Japanese Yen, the Euro, the Brazilian Real, the British Pound and the Hong Kong Dollar. Assets and liabilities
denominated in foreign currencies are translated at the rate of exchange on the balance sheet date. Revenues and expenses are
translated using the average exchange rate for the period. Net gains and losses resulting from the translation of foreign financial
statements are recorded as accumulated other comprehensive income (loss) in stockholders’ (deficit) equity. Net foreign currency
gains or (losses) resulting from transactions in currencies other than the functional currencies are included in other income (expense),
net and discontinued operations in the accompanying consolidated statements of operations. For the years ended December 31, 2016,
2015 and 2014, the Company recorded net foreign currency losses in continuing operations of approximately $0.4 million, $0.7
million and a gain of $0.8 million, respectively.
Warrants to Purchase Common Stock
Common stock warrants that contain compliance covenants and cash payment obligations are classified as common stock
warrant liabilities on the consolidated balance sheet. In September 2016, in connection with the Globus Transaction, Deerfield
exercised its right to convert all outstanding Initial Warrants and Draw Warrants into shares of the Company's common stock based on
the Black-Scholes value of the warrants. The outstanding warrants were converted into 268,614 shares of the Company's common
stock. Prior to the conversion, the Company recorded the warrant liability at fair value and adjusted the carrying value of these
F-12
common stock warrants to their estimated fair value at each reporting date with the increases or decreases in the fair value of such
warrants at each reporting date recorded as other income (expense) in the consolidated statements of operations.
Fair Value Measurements
The carrying amount of financial instruments consisting of cash, restricted cash, trade accounts receivable, prepaid expenses and
other current assets, accounts payable, accrued expenses, accrued compensation and current portion of long-term debt included in the
Company’s consolidated financial statements are reasonable estimates of fair value due to their short maturities. Based on the
borrowing rates currently available to the Company for loans with similar terms, management believes the fair value of long-term debt
approximates its carrying value.
Authoritative guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as
follows:
Level 1:
Observable inputs such as quoted prices in active markets;
Level 2:
Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and
Level 3:
Unobservable inputs in which there is little or no market data, which require the reporting entity to develop
its own assumptions.
The Company does not maintain any financial instruments that are considered to be Level 1, Level 2 or Level 3 instruments as
of December 31, 2016. Prior to the conversion of the outstanding warrants, the Company classified its common stock warrant
liabilities within Level 3 of the fair value hierarchy because they are valued using valuation models with significant unobservable
inputs. The following table provides a reconciliation of liabilities measured at fair value using significant unobservable inputs (Level
3) for the year ended December 31, 2016 (in thousands):
Balance at December 31, 2013
Issuance
Changes in fair value
Balance at December 31, 2014
Changes in fair value
Balance at December 31, 2015
Changes in fair value
Conversion to common stock
Balance at December 31, 2016
Common Stock
Warrant
Liabilities
$
$
—
11,280
(2,578)
8,702
(8,015)
687
387
(1,074)
—
Prior to the conversion to common stock described in Note 6, the common stock warrant liabilities were measured at fair value
using the Black-Scholes option pricing valuation model. The assumptions used in the Black-Scholes option pricing valuation model
for the common stock warrant liabilities were: (a) a risk-free interest rate based on the rates for U.S. Treasury zero-coupon bonds with
maturities similar to those of the remaining contractual term of the warrants; (b) an assumed dividend yield of zero based on the
Company’s expectation that it will not pay dividends in the foreseeable future; (c) an expected term based on the remaining
contractual term of the warrants; and (d) an expected volatility based upon the Company's historical volatility over the remaining
contractual term of the warrants. The significant unobservable input used in measuring the fair value of the common stock warrant
liabilities associated with the Deerfield Facility Agreement (described in Note 6 below) was the expected volatility.
Research and Development
Research and development expense consists of costs associated with the design, development, testing, and enhancement of the
Company’s products. Research and development costs also include salaries and related employee benefits, research-related overhead
expenses, fees paid to external service providers, and costs associated with the Company’s Scientific Advisory Board and Executive
Surgeon Panels. Research and development costs are expensed as incurred.
In-Process Research and Development
In-process research and development (“IPR&D”) consists of acquired research and development assets that are not part of an
acquisition of a business and were not technologically feasible on the date the Company acquired them and had no alternative future
use at that date or assets acquired in a business acquisition that are determined to have no alternative future use. The Company expects
all acquired IPR&D will reach technological feasibility, but there can be no assurance that commercial viability of these products will
ever be achieved. The nature of the efforts to develop the acquired technologies into commercially viable products consists principally
F-13
of planning, designing, developing and testing products in order to obtain regulatory approvals. If commercial viability were not
achieved, the Company would likely look to other alternatives to provide these products. Until the technological feasibility of the
acquired research and development assets are established, the Company expenses these costs.
Leases
The Company leases its facilities and certain equipment and vehicles under operating leases, and certain equipment under
capital leases. For facility leases that contain rent escalation or rent concession provisions, the Company records the total rent payable
during the lease term on a straight-line basis over the term of the lease. The Company records the difference between the rent paid and
the straight-line rent within accrued expenses in the accompanying consolidated balance sheets.
Product Shipment Cost
Product shipment costs are included in sales and marketing expense in the accompanying consolidated statements of operations.
Product shipment costs totaled $2.7 million, $3.0 million and $3.0 million for the years ended December 31, 2016, 2015 and 2014,
respectively.
Stock-Based Compensation
The Company accounts for stock-based compensation under provisions which require that share-based payment transactions
with employees be recognized in the financial statements based on their fair value and recognized as compensation expense over the
vesting period. The amount of expense recognized during the period is affected by subjective assumptions, including estimates of the
future volatility of the Company’s stock price, the expected term for its stock options, the number of options expected to ultimately
vest, and the timing of vesting for the Company’s share-based awards.
The Company uses a Black-Scholes option pricing valuation model to estimate the fair value of its stock option awards. The
calculation of the fair value of the awards using the Black-Scholes option pricing model is affected by the Company’s common stock
price on the date of grant as well as assumptions regarding the following:
•
•
•
•
Estimated volatility is a measure of the amount by which the Company’s common stock price is expected to fluctuate each
year during the expected life of the award. The Company’s estimated volatility through December 31, 2016 was based on
a weighted-average volatility of its actual historical volatility over a period equal to the expected remaining life of the
awards.
The expected term represents the period of time that awards granted are expected to be outstanding. Through December
31, 2016, the Company calculated the expected term using a weighted-average term based on historical exercise patterns
and the term from option date to full exercise for the options granted within the specified date range.
The risk-free interest rate is based on the yield curve of a zero-coupon U.S. Treasury bond on the date the stock option
award is granted with a maturity equal to the expected term of the stock option award.
The assumed dividend yield is based on the Company’s expectation of not paying dividends in the foreseeable future.
The Company used historical data to estimate the number of future stock option forfeitures. Stock-based compensation recorded
in the Company’s consolidated statement of operations is based on awards expected to ultimately vest and has been reduced for
estimated forfeitures. The Company’s estimated forfeiture rates may differ from its actual forfeitures which would affect the amount
of expense recognized during the period.
The Company accounts for stock option grants to non-employees in accordance with provisions which require that the non-
employee awards are remeasured at each reporting period end and fair value of these instruments be recognized as an expense over the
period in which the related services are rendered.
Stock-based compensation expense of awards with performance conditions is recognized over the period from the date the
performance condition is determined to be probable of occurring through the time the applicable condition is met. Determining the
likelihood and timing of achieving performance conditions is a subjective judgment made by management which may affect the
amount and timing of expense related to these share-based awards. Share-based compensation is adjusted to reflect the value of
options which ultimately vest as such amounts become known in future periods.
F-14
Valuation of Stock Option Awards
The assumptions used to compute the stock-based compensation costs for the stock options granted during the years ended
December 31, 2016, 2015 and 2014 are as follows:
Risk-free interest rate
Expected dividend yield
Weighted average expected life (years)
Volatility
2016
Year Ended December 31,
2015
1.6-1.8%
—
5.4-5.5
59-68%
1.78%
—
5.69
78%
2014
1.8-1.9%
—
5.4-5.5
60-71%
Stock-Based Compensation Costs
The compensation cost that has been included in the Company’s consolidated statement of operations for all stock-based
compensation arrangements is detailed as follows (in thousands):
Cost of revenues
Research and development
Sales and marketing
General and administrative
Discontinued operations
Total
Year Ended December 31,
2015
2014
2016
$
$
36 $
438
258
894
—
1,626 $
72 $
286
316
1,893
76
2,643 $
274
2,080
385
1,665
150
4,554
The amounts provided above include stock-based compensation expense of $0.2 million, $0.1 million and $1.9 million during
the years ended December 31, 2016, 2015 and 2014, respectively, related to the vesting of stock options and awards granted to non-
employees under consulting agreements.
Income Taxes
The Company accounts for income taxes in accordance with provisions which set forth an asset and liability approach that
requires the recognition of deferred tax assets and deferred tax liabilities for the expected future tax consequences of temporary
differences between the carrying amounts and the tax bases of assets and liabilities. Valuation allowances are established when
necessary to reduce deferred tax assets to the amount expected to be realized. In making such determination, a review of all available
positive and negative evidence must be considered, including scheduled reversal of deferred tax liabilities, projected future taxable
income, tax planning strategies, and recent financial performance.
The Company recognizes interest and penalties related to uncertain tax positions as a component of the income tax provision.
Net Loss per Share
Basic earnings per share (“EPS”) is calculated by dividing the net income or loss available to common stockholders by the
weighted average number of common shares outstanding for the period, as adjusted for the 1-for-12 reverse stock split, without
consideration for common stock equivalents. Diluted EPS is computed by dividing the net income or loss available to common
stockholders by the weighted average number of common shares outstanding for the period and the weighted average number of
dilutive common stock equivalents outstanding for the period determined using the treasury-stock method, as adjusted for the 1-for-12
reverse stock split. For purposes of this calculation, common stock subject to repurchase by the Company, options and warrants are
considered to be common stock equivalents and are only included in the calculation of diluted earnings per share when their effect is
dilutive.
F-15
The following table sets forth the computation of basic and diluted loss per share, as adjusted for the 1-for-12 reverse stock split
stock split (in thousands, except per share data):
2016
Year Ended December 31,
2015
2014
Continuing
operations
Discontinued
operations
Continuing
operations
Discontinued
operations
Continuing
operations
Discontinued
operations
Numerator
Net loss, basic
Decrease in fair value of warrants
Diluted net loss attributable to common stockholders
Denominator
Weighted average common shares outstanding
Weighted average unvested common shares subject to
repurchase
Weighted average common shares outstanding - basic
Effect of dilutive securities:
Common stock warrants
Weighted average common shares outstanding,
diluted
Basic net loss per share
Diluted net loss per share
$
$
$ (26,301) $
—
(26,301)
(3,624) $ (171,253) $
—
(3,624) (171,253)
—
(7,423) $
—
(7,423)
(98) $ (12,784)
—
(12,784)
(2,578)
(2,676)
8,646
8,646
8,365
8,365
8,178
8,178
(64)
8,582
(64)
8,582
(68)
8,298
(68)
8,298
(66)
8,112
(66)
8,112
—
—
—
—
32
32
8,582
(3.06) $
(3.06) $
8,582
(0.42) $
(0.42) $
8,298
(20.64) $
(20.64) $
8,298
(0.89) $
(0.89) $
8,145
(0.01) $
(0.33) $
8,145
(1.58)
(1.57)
As of December 31, 2016, 2015 and 2014, none of the outstanding shares of redeemable preferred stock were convertible to
common stock.
The anti-dilutive securities not included in diluted net loss per share were as follows, as adjusted for the 1-for-12 reverse stock
split (in thousands):
Options to purchase common stock
Warrants to purchase common stock
Unvested restricted stock awards
Year Ended December 31,
2015
2016
2014
604
8
177
789
662
962
68
1,691
588
60
66
714
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (“FASB”) issued new accounting guidance related to revenue
recognition. This new standard replaces all current U.S. GAAP guidance on this topic and eliminates all industry-specific guidance.
The new revenue recognition standard provides a unified model to determine when and how revenue is recognized. The core principle
is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects
the consideration for which the entity expects to be entitled in exchange for those goods or services. This guidance, including all
subsequent clarifications, is effective for the Company for annual and interim reporting periods in fiscal years beginning after
December 15, 2017 and can be applied either retrospectively to each period presented or as a cumulative-effect adjustment as of the
date of adoption. The Company performed a preliminary assessment of the impact of the new standard on the consolidated financial
statements, and considered all items outlined in the standard. In assessing the impact, the Company has outlined all revenue generating
activities, mapped those activities to deliverables and traced those deliverables to the standard. The Company is now assessing what
impact the change in standard will have on those deliverables. The Company will continue to evaluate the future impact and method of
adoption of the new standard and related amendments on the consolidated financial statements and related disclosures throughout
2017. The Company will adopt the new standard beginning January 2018.
F-16
In August 2014, the FASB issued guidance related to disclosures of uncertainties about an entity’s ability to continue as a going
concern. The guidance requires management to evaluate whether there are conditions and events that raise substantial doubt about the
entity’s ability to continue as a going concern within one year after the financial statements are issued. Management is required to
make this evaluation for both annual and interim reporting periods and will have to make certain disclosures if it concludes that
substantial doubt exists or when its plans alleviate substantial doubt about the entity’s ability to continue as a going concern.
Substantial doubt exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity
will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued. The
guidance is effective for annual periods ending after December 15, 2016 and for interim reporting periods thereafter. The Company
adopted the standard for the annual reporting period ending December 31, 2016.
In April 2015, the FASB issued guidance, which amends current presentation guidance by requiring that debt issuance costs
related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt
liability, consistent with debt discounts. Prior to the issuance this guidance, debt issuance costs were required to be presented as an
asset in the balance sheet. The Company adopted the provisions of the new guidance during the interim period ended March 31, 2016
and prior period amounts have been reclassified to conform to the current period presentation. As of December 31, 2015, $0.4 million
of debt issuance costs were reclassified in the consolidated balance sheet from prepaid expenses and other current assets to current
portion of long-term debt. The adoption of ASU 2015-03 did not impact the Company's consolidated statement of operations,
comprehensive income (loss) or cash flows.
In July 2015, the FASB issued new accounting guidance, which changes the measurement principle for inventory from the
lower of cost or market to lower of cost and net realizable value for entities that do not measure inventory using the last-in, first-out or
retail inventory method. The guidance also eliminates the requirement for these entities to consider replacement cost or net realizable
value less an approximately normal profit margin when measuring inventory. The guidance is effective for annual periods beginning
after December 15, 2016, and interim periods within those annual periods. The Company is evaluating the impact of adopting this new
accounting standard on its financial statements.
In February 2016, the FASB issued new accounting guidance, which changes several aspects of the accounting for leases,
including the requirement that all leases with durations greater than twelve months be recognized on the balance sheet. The guidance
is effective for annual periods and interim periods in fiscal years beginning after December 15, 2018. The Company is evaluating the
impact of adopting this new accounting standard on its financial statements.
In March 2016, the FASB issued new accounting guidance, which changes several aspects of the accounting for share-based
payment award transactions, including accounting and cash flow classification for excess tax benefits and deficiencies, forfeitures, and
tax withholding requirements and cash flow classification. The guidance is effective for annual periods and interim periods in fiscal
years beginning after December 15, 2016. The Company is evaluating the impact of adopting this new accounting standard on its
financial statements.
In August 2016, the FASB issued new accounting guidance, which eliminates the diversity in practice related to the
classification of certain cash receipts and payments in the statement of cash flows, by adding or clarifying guidance on eight specific
cash flow issues. The guidance is effective for annual and interim reporting periods beginning after December 15, 2017, with early
adoption permitted. The amendments in this update should be applied retrospectively to all periods presented, unless deemed
impracticable, in which case, prospective application is permitted. The Company is currently evaluating the new guidance and has not
determined the impact this standards update may have on its financial statements.
3. Balance Sheet Details
Accounts Receivable, net
Accounts receivable consist of the following (in thousands):
Accounts receivable
Less allowance for doubtful accounts
Accounts receivables, net
December 31,
2016
2015
$
$
19,870 $
(1,358)
18,512 $
27,639
(769)
26,870
F-17
Inventories, net
Inventories consist of the following (in thousands):
Raw materials
Work-in-process
Finished goods
Less reserve for excess and obsolete finished goods
Inventories, net
December 31,
2016
2015
$
$
7,301 $
823
38,469
46,593
(16,500)
30,093 $
7,237
1,908
39,388
48,533
(15,901)
32,632
Property and Equipment, net
Property and equipment consist of the following (in thousands except for useful lives):
Surgical instruments
Machinery and equipment
Computer equipment
Office furniture and equipment
Leasehold improvements
Construction in progress
Less accumulated depreciation and amortization
Property and equipment, net
$
Useful lives
(in years)
4
7
3
5
various
n/a
$
December 31,
2016
2015
53,095 $
5,435
3,511
2,695
3,467
445
68,648
(53,572)
15,076 $
52,404
14,416
3,816
3,426
3,467
139
77,668
(61,587)
16,081
Total depreciation expense was $7.4 million, $10.8 million and $9.5 million for the years ended December 31, 2016, 2015 and
2014, respectively. At December 31, 2016, assets recorded under capital leases of $2.1 million were included in the machinery and
equipment balance. At December 31, 2015, assets recorded under capital leases of $2.6 million were included in the machinery and
equipment balance and $0.1 million are included in the construction in progress balance. Amortization of assets under capital leases is
included in depreciation expense.
Intangible Assets
Intangible assets consist of the following (in thousands except for useful lives):
Developed product technology
Intellectual property
License agreements
Trademarks and trade names
Customer-related
Distribution network
Less accumulated amortization
Intangible assets, net
Remaining Avg.
Useful lives
(in years)
—
—
2
—
8
8
December 31,
2016
2015
$
$
13,876 $
1,004
5,265
732
7,458
4,027
32,362
(26,651)
5,711 $
13,876
1,004
5,015
732
7,458
4,027
32,112
(23,306)
8,806
Total expense related to amortization of intangible assets was $1.6 million, $3.0 million and $2.2 million for the years ended
December 31, 2016, 2015 and 2014, respectively.
F-18
In connection with the sale of the International Business (see Note 4), the Company determined that certain intangible assets
related to the Company's previous acquisition of Scient'x, including customer relationships, distribution network and key product
tradename intangible assets, no longer had a business purpose and no cash flows associated with these assets are expected in the
future. As a result, the Company recorded $1.7 million as intangible impairment expense during the year ended December 31, 2016.
Prior to the impairment, amortization of these intangible assets had been recorded in amortization of acquired intangible assets within
operating expenses.
During 2016, due to revised marketing strategies for an interbody fusion device, the Company evaluated the related intangible
asset for impairment. As a result of this impairment analysis, the Company expensed $0.5 million as an impairment charge in cost of
goods sold in 2016 for the write-off of intangible asset related to this product.
During 2015, the Company entered into an exclusive distribution agreement with a third party to market a biologic product. The
Company expensed $0.3 million as an impairment charge in cost of goods sold in 2016 for the write-off of an intangible asset related
to this product. Additionally, due to a revised marketing strategy for the Company's Epicage interbody fusion device, the Company
evaluated the related intangible asset for impairment. As a result of this impairment analysis, the Company expensed $0.9 million as
an impairment charge in cost of goods sold in 2015 for the write-off of an intangible asset related to this product.
In connection with the step two goodwill impairment test performed in the third quarter of 2015, the Company determined that
the physician education intangible acquired in the Scient’x acquisition was impaired. As a result, the Company expensed $0.9 million
included in goodwill and intangible impairment of discontinued operations in the year ended December 31, 2015.
The future expected amortization expense related to intangible assets as of December 31, 2016 is as follows (in thousands):
Year Ending December 31,
2017
2018
2019
2020
2021
Thereafter
Total
$
$
936
750
689
688
688
1,960
5,711
Goodwill
The changes in the carrying amount of goodwill from December 31, 2015 through December 31, 2016 were as follows (in
thousands):
Balance at January 1
Impairment charge
Effect of foreign exchange rate on goodwill
Balance at December 31
2016
— $
—
—
— $
2015
171,333
(164,263)
(7,070)
—
$
$
In the third quarter of 2015, the market value of the Company’s common stock substantially declined. As a result of this decline,
the Company determined that it had an indicator of impairment of its goodwill, and an interim test of goodwill impairment was
required. As a result of this interim test, the Company recorded a charge of $164.3 million, representing the write-off of the remaining
balance of goodwill in the third quarter of 2015.
F-19
Accrued Expenses
Accrued expenses consist of the following (in thousands):
Commissions and sales milestones
Payroll and payroll related
Litigation settlements
Globus related accruals
Accrued professional fees
Royalties
Restructuring and severance accruals
Accrued taxes
Guaranteed collaboration compensation, current
Accrued interest
Other
Total accrued expenses
December 31,
2016
2015
$
$
4,202 $
2,384
4,400
3,830
3,093
1,347
1,328
404
2,228
387
3,986
27,589 $
3,963
3,947
4,400
—
1,972
1,199
505
765
—
999
3,425
21,175
4. Discontinued Operations
In order to pay down a portion of its debt and improve its liquidity position and future cash flows, on September 1, 2016, the
Company closed the Globus Transaction (described in Note 1). Following the closing of the Globus Transaction, the Company only
sells its products in the U.S. market and is prohibited from marketing and selling its products outside the United States and its
possessions and territories until the date that is two years following the termination of the Supply Agreement (as described below). As
a result of the Globus Transaction, the Company has retrospectively revised the consolidated statements of operations and cash flows
for the years ended December 31, 2015 and 2014 and the consolidated balance sheet as of December 31, 2015 to reflect the financial
results from the International Business, and the related assets and liabilities, as discontinued operations.
At the closing of the Globus Transaction, Globus paid the Company $80 million in cash, subject to a working capital
adjustment. On September 1, 2016, the Company used approximately $66 million of the consideration received to (i) repay in full all
amounts outstanding and due under the Company’s Deerfield Facility Agreement (described in Note 6 below) and (ii) repay certain of
its outstanding indebtedness under the Company’s Amended Credit Facility with MidCap (described in Note 6 below), in each case,
including debt-related costs. Also on September 1, 2016, the Company entered into a five-year term credit, security and guaranty
agreement with Globus (the “Globus Facility Agreement”), as further described in Note 6, pursuant to which Globus agreed to loan
the Company up to $30 million, subject to the terms and conditions set forth in the Globus Facility Agreement.
The following table summarizes the preliminary calculation of the gain on sale (in thousands):
Consideration received
Cash included in assets sold
Transaction costs
Net cash proceeds
Less:
Product supply obligation
Working capital adjustment
Carrying value of business and assets sold
Net gain on sale of business
$
$
80,000
(4,250)
(5,960)
69,790
(1,927)
(2,295)
(57,633)
7,935
The Company is evaluating certain income tax related items that are pending final resolution.
The results of operations from discontinued operations presented below include certain allocations that management believes
fairly reflect the utilization of services provided to the International Business. The allocations do not include amounts related to
general corporate administrative expenses. Therefore, the results of operations from the International Business do not necessarily
reflect what the results of operations would have been had the International Business operated as a stand-alone entity.
F-20
In connection with the Globus Transaction, the Company entered into a product manufacture and supply agreement (the “Supply
Agreement”) with Globus, pursuant to which the Company agreed to supply to Globus certain of its implants and instruments (the
“Products”), previously offered for sale by the Company in international markets at agreed-upon prices for a minimum term of three
years, with the option for Globus to extend the term for up to two additional twelve month periods subject to Globus meeting specified
purchase requirements. In accordance with authoritative guidance, certain intercompany sales transactions have been reported under
continuing operations as the Company will have continuing involvement due to future sales to Globus under the Supply Agreement. In
connection with the Globus Transaction, Globus received a credit of up to a $2.2 million to be applied against product purchases
pursuant to the Supply Agreement during a six-month period commencing one month after the closing of the Globus Transaction,
which has been included as a reduction of the consideration received for the sale of the International Business and will be recognized
as revenue upon fulfilment by the Company of product purchases by Globus.
The agreements entered into concurrently with the sale of the International Business, including the Transition Services
Agreement and the Supply Agreement, contain various elements and, as such, are deemed to be an arrangement with multiple
deliverables as defined under authoritative accounting guidance (see Note 2). Several non-contingent deliverables were identified
within the agreements. The Company identified the International Business, contract supply services, transition services and the Globus
Facility as separate non-contingent deliverables within the arrangement. The Company determined the estimated selling price (fair
value) for each of the non-contingent deliverables on a standalone basis by utilizing relevant market data and entity-specific factors.
Based on the respective standalone fair values of the deliverables, there was no discount to allocate among the deliverables and the
consideration received for each deliverable approximated standalone fair value. As such, none of the purchase consideration was
allocated to these elements.
Included in the results of continuing operations for the years ended December 31, 2016, 2015 and 2014 are revenues of $10.3
million, $19.2 and $27.1 million, respectively, and cost of revenue of $8.9 million, $18.5 and $25.7 million, respectively, that
represent intercompany transactions that, prior to the Globus Transaction, were eliminated in the Company's consolidated financial
statements.
During the year ended December 31, 2016, the Company recorded $2.6 million in revenue and $2.3 million in cost of sales from
the Supply Agreement that are included in the continuing operations.
In connection with the Globus Transaction, the Company included interest expense of $7.0 million, $8.6 million and $10.6
million for the years ended December 31, 2016, 2015 and 2014, respectively, under the Deerfield Facility Agreement and Amended
Credit Facility (as further described in Note 6) in net loss from discontinued operations to the extent these debt facilities were repaid
using the proceeds from the Globus Transaction.
F-21
The following table summarizes the results of discontinued operations for the periods presented in the consolidated statements
of operations for the years ended December 31, 2016 and 2015 and 2014 (in thousands):
Discontinued operations
Revenues
Cost of revenues
Amortization of acquired intangible assets
Gross profit
Operating (income) expenses:
Research and development
Sales and marketing
General and administrative
Amortization of intangible assets
Goodwill and intangible impairment
Restructuring expenses
Net gain on sale of business
Total operating expenses
Operating income
Other income (expense):
Interest income
Interest expense
Other income (expense), net
Total other income (expense)
Income (loss) from discontinued operations before taxes
Income tax provision
Loss from discontinued operations, net of applicable taxes
$
Years ended December 31,
2015
2014
2016
$
40,130 $
19,381
1,291
19,458
50,891 $
17,376
1,453
32,062
52,355
16,826
1,787
33,742
206
21,397
11,075
—
—
706
—
33,384
358
—
(10,594)
(1,869)
(12,463)
(12,105)
679
(12,784)
51
12,980
4,846
622
—
794
(7,935)
11,358
8,100
45
(7,004)
1,883
(5,076)
3,024
6,648
(3,624) $
152
19,055
6,741
1,200
908
591
—
28,647
3,415
42
(8,588)
(466)
(9,012)
(5,597)
1,826
(7,423) $
The following table summarizes the assets and liabilities of discontinued operations as of December 31, 2016 and 2015 related
to the International Business (in thousands):
December 31,
2016
December 31,
2015
$
$
$
$
159 $
—
48
157
364
—
—
61
425 $
43 $
689
—
732
—
732 $
4,934
11,449
12,276
1,551
30,210
5,850
12,810
797
49,667
627
8,616
648
9,891
1,516
11,407
Assets
Current assets:
Cash
Accounts receivable, net
Inventories, net
Prepaid expenses and other current assets
Total current assets of discontinued operations
Property and equipment, net
Intangible assets, net
Other assets
Total assets of discontinued operations
Liabilities
Current liabilities:
Accounts payable
Accrued expenses
Deferred revenue
Total current liabilities of discontinued operations
Other long-term liabilities
Total liabilities of discontinued operations
F-22
Included in the statement of cash flows for the year ended December 31, 2016 and 2015 are the following capital expenditures
and non-cash adjustments related to the discontinued operations (in thousands):
Depreciation and amortization
Provision for doubtful accounts
Provision for excess and obsolete inventory
Capital expenditures
Interest expense related to amortization of debt discount
and debt issuance costs
$
$
$
$
$
Year ended December 31,
2015
2014
2016
3,836 $
— $
151 $
1,319 $
5,261 $
170 $
380 $
2,975 $
6,595
—
954
2,946
2,052 $
2,627 $
4,944
5. License and Consulting Agreements
OsseoFix Spinal Fracture Reduction System License Agreement
On April 16, 2009, the Company and Stout Medical Group LP (“Stout”) amended the license agreement that the parties had
entered into in September 2007 (the “License Amendment”) that provides the Company with a worldwide license to develop and
commercialize Stout’s proprietary intellectual property related to a treatment for vertebral compression fractures. The effective date of
the License Amendment is March 31, 2009. Under the License Amendment, the timing of the minimum royalty payments has been
adjusted and Stout’s ability to terminate the License Amendment was revised. Under the original license agreement, the Company’s
minimum royalty obligation began in the year ending December 31, 2009 and there are milestones due upon attainment of sales
volumes. Pursuant to the License Amendment, the minimum royalty obligation is suspended until a licensed product obtains
regulatory approval from the United States Food and Drug Administration (the “FDA”). In addition, under the terms of the License
Amendment, Stout has the ability to terminate the License Amendment if the Company is not using commercially reasonable efforts to
obtain regulatory approval to market and sell a licensed product; provided that the Company has the right to delay such termination in
exchange for making certain payments to Stout. If, during the time period when such payments are made, the Company were to make
a regulatory filing for the marketing and sale of a licensed product, such termination will be null and void. Pursuant to the License
Amendment, Stout is entitled to retain all up-front payments that had been previously paid to it. The other material terms of the license
agreement were not changed in the License Amendment.
In August 2014, the Company entered a third amendment (the “Third Amendment”) to the License Agreement. Pursuant to the
Third Amendment: (i) the royalty rate paid by the Company for the net sales of licensed products is a fixed amount per quarter
through December 31, 2016; (ii) the royalty rate starting in 2017 will be increased from 7.0% to 8.5%; (ii) starting in 2017, the
minimum royalty obligation is $0.2 million per year, with such minimum royalty obligation being further reduced stating in 2018;
(iii) the territory is amended so that the United States is removed from the territory in which the Company can sell and market licensed
products; (iv) all obligations of the Company to pursue a clinical trial in the United States are deleted; and (v) all milestone payments
based on the achievement of certain sales milestones are deleted. In connection with this amendment the Company reversed the $1.7
million accrual it had recorded for the sales milestone payment into cost of goods sold for the year ended December 31, 2014.
Asset Purchase Agreement
In July 2014, the Company entered into an asset purchase and product development services agreement (the "Asset Agreement")
whereby the Company purchased rights to the conceptual design for an intervertebral implant device. The financial terms of the
Agreement include payments in cash and the Company's common stock upon achievement of various milestones. The Company
accounted for this arrangement as an asset acquisition. In the year ended December 31, 2014, the Company made cash payments
totaling $0.2 million and issued 72,992 shares of the Company's common stock valued at $0.1 million. The Company recognized the
cash and stock payments of $0.3 million as in-process research and development expense in the year ended December 31, 2014.
Under the terms of the Asset Agreement as amended in 2015 the Company was obligated to pay $0.2 million cash compensation and
issue 72,992 shares of the Company's common stocks valued at less than $0.1 million. The Company expensed $0.3 million as in-
process research and development in the year ended December 31, 2015.
6. Debt
MidCap Facility Agreement
On August 30, 2013, the Company entered into the amended and restated credit, security and guaranty agreement with MidCap
Funding IV, LLC (“MidCap”), as amended to date (the “Amended Credit Facility”), which amended and restated the prior credit
facility that the Company had with MidCap. On September 1, 2016, the Company and MidCap entered into a Fifth Amendment to the
Amended Credit Facility (the “MidCap Fifth Amendment”) that: (a) permitted (i) the Globus Transaction, (ii) the release of Alphatec
F-23
International LLC and Alphatec Pacific, Inc. as credit parties, (iii) the payment in full of all obligations to Deerfield Private Design
Fund II, L.P., Deerfield Private Design International II, L.P., Deerfield Special Situations Fund, L.P. and Deerfield Special Situations
International Master Fund, L.P. (collectively, “Deerfield”) under the Facility Agreement between the Company and Deerfield, dated
as of March 17, 2014, as amended to date (the “Deerfield Facility Agreement”), and (iv) the incurrence of debt under the Globus
Facility Agreement and the granting of liens in favor of Globus; (b) reduced the revolving credit commitment to $22.5 million and the
term loan commitment to $5 million; (c) revised the existing financial covenant package; and (d) extended the commitment expiry
date from December 31, 2016 to December 31, 2019. In connection with the prepayment of the term loan under the Amended Credit
Facility, the Company incurred a prepayment fee of $0.6 million payable to MidCap.
As of December 31, 2016, $12.5 million was outstanding under the revolving line of credit and $4.8 million was outstanding
under the term loan.
The term loan interest rate is priced at the London Interbank Offered Rate ("LIBOR") plus 8.0%, subject to a 9.5% floor, and the
revolving line of credit interest rate remains priced at LIBOR plus 6.0%, reset monthly. At December 31, 2016, the revolving line of
credit carried an interest rate of 6.6% and the term loan carries an interest rate of 9.5%. The borrowing base is determined, from time
to time, based on the value of domestic eligible accounts receivable and domestic eligible inventory. As collateral for the Amended
Credit Facility, the Company granted MidCap a security interest in substantially all of its assets, including all accounts receivable and
all securities evidencing its interests in its subsidiaries. In addition to monthly payments of interest, monthly repayments of $0.2
million in 2017 and $0.3 million in 2018 through maturity are due, with the remaining principal due upon maturity.
The Amended Credit Facility includes traditional lending and reporting covenants including a liquidity calculation and a fixed
charge coverage ratio to be maintained by the Company. The Amended Credit Facility also includes several event of default
provisions, such as payment default, insolvency conditions and a material adverse effect clause, which could cause interest to be
charged at a rate which is up to five percentage points above the rate effective immediately before the event of default or result in
MidCap’s right to declare all outstanding obligations immediately due and payable. The financial covenants of the Amended Credit
Facility are not effective until April 2018 (See Note 15). There is no assurance that the Company will be in compliance with the
financial covenants of the Amended Credit Facility in the future.
On March 11, 2016, the Company entered into a third amendment and waiver to the Amended Credit Facility with MidCap (the
"Third Amendment to the Amended Credit Facility"). The Third Amendment to the Amended Credit Facility extended the maturity
date of the Amended Credit Facility from August 30, 2016 to December 31, 2016 and contained an amendment fee in the amount of
$0.5 million, which was due and payable at the earlier of the termination of the Amended Credit Facility or the maturity date. The
Third Amendment to the Amended Credit Facility also contained a waiver of the December 2015 defaults under the Amended Credit
Facility, provided a waiver for the fixed charge coverage ratio for January 2016 and eliminated the fixed charge coverage ratio
covenant for February 2016.
On August 8, 2016, the Company entered into a Fourth Amendment to the Amended Credit Facility with MidCap (the "Fourth
Amendment to the Amended Credit Facility"). The Fourth Amendment to the Amended Credit Facility provided for a $2.2 million
increase to the borrowing base until September 15, 2016, and included an amendment fee of $0.2 million, which was due and payable
on August 8, 2016. The Fourth Amendment to the Amended Credit Facility also contained a waiver for the May and June 2016 non-
compliances.
At December 31, 2016, unamortized debt discount related to the prior and Amended Credit Facility within the consolidated
balance sheet was $1.9 million, which will be amortized over the remaining term of the Amended Credit Facility.
Deerfield Facility Agreement
On March 17, 2014, the Company entered into the Deerfield Facility Agreement, pursuant to which Deerfield agreed to loan the
Company up to $50 million, subject to the terms and conditions set forth in the Deerfield Facility Agreement. Under the terms of the
Deerfield Facility Agreement, the Company had the option, but was not required, upon certain conditions to draw the entire amount
available under the Deerfield Facility Agreement, at any time until January 30, 2015, provided that the initial draw be used for a
portion of the payments made in connection with the Orthotec settlement described in Note 8 below. The Company agreed to pay
Deerfield, upon each disbursement of funds under the Deerfield Facility Agreement, a transaction fee equal to 2.5% of the principal
amount of the funds disbursed.
In connection with the execution of the Deerfield Facility Agreement on March 17, 2014, the Company issued to Deerfield
warrants to purchase an aggregate of 520,833 shares of the Company’s common stock, which are immediately exercisable and have an
exercise price equal to $16.68 per share (the “Initial Warrants”). Additionally, the Company agreed that each disbursement borrowing
under the Deerfield Facility Agreement be accompanied by the issuance to Deerfield of warrants to purchase up to 833,333 shares of
the Company’s common stock, in proportion to the amount of draw compared to the total $50 million facility (the "Draw Warrants").
F-24
On March 20, 2014, the Company made an initial draw of $20 million under the Deerfield Facility Agreement and received net
proceeds of $19.5 million to fund the portion of the settlement payment obligations that were due in 2014 to Orthotec, LLC. The $0.5
million transaction fee was recorded as a debt discount and was being amortized over the term of the draw, which ends March 20,
2019. In connection with this borrowing, the Company issued Draw Warrants to purchase 333,333 shares of common stock at an
exercise price of $16.68 per share, which were valued at $4.7 million and recorded as a debt discount, which were being amortized
over the term of the $20 million draw. Additionally, $2.3 million of the value of the Initial Warrants was reclassified as a debt
discount and is being amortized through interest expense over the term of the debt using the effective interest method.
On November 21, 2014, the Company made a second draw of $6.0 million under the Deerfield Facility Agreement and received
net proceeds of $5.9 million to fund a portion of the Orthotec settlement payments due through 2016. The $0.2 million transaction fee
was recorded as a debt discount and was being amortized over the remaining term of the draw, which ends March 20, 2019. In
connection with this second draw, the Company issued Draw Warrants to purchase 100,000 shares of common stock at an exercise
price of $16.68 per share, which Draw Warrants were valued at $0.9 million and were recorded as a debt discount, which was being
amortized over the term of the debt using the effective interest method. Additionally, $0.2 million of the value of the Initial Warrants
was reclassified as a debt discount and was being amortized through interest expense over the term of the debt using the effective
interest method. No amounts remain available for the Company to borrow under the Facility Agreement.
On February 5, 2016, the Company entered into a Limited Waiver and Second Amendment to the Deerfield Facility Agreement
(the “Deerfield Facility Agreement Second Amendment”) with Deerfield. The Deerfield Facility Agreement Second Amendment
increased the interest rate under the Facility Agreement from 8.75% per annum to 14.75% per annum. In addition, the Deerfield
Facility Agreement Second Amendment provided that the Company may elect to have (i) until August 30, 2016, six percent (6%), and
(ii) thereafter, three percent (3%), in each case, of the interest on the outstanding principal amount under the Facility Agreement paid
in kind, which would be added to the outstanding principal amount under the Deerfield Facility Agreement and bear interest at the
interest rate of 14.75% per annum (the “PIK Interest”). All accrued and unpaid PIK Interest was due and payable when the
outstanding amounts under the Facility Agreement were due and payable thereunder or were fully repaid, whichever occurs first. The
Deerfield Facility Agreement Second Amendment also contained an amendment fee in the amount of $0.6 million, which was due and
payable in installments of $0.2 million on each of the third, fourth and fifth anniversaries of the Deerfield Facility Agreement;
provided that all unpaid amendment fees shall be due and payable when the outstanding amounts under the Facility Agreement are due
and payable or are fully repaid, whichever occurs first. The Deerfield Facility Agreement Second Amendment also changed the date
from March 31, 2017 to March 31, 2018, as the date through which the Company must pay interest in the event the Company prepays
amounts outstanding under the Deerfield Facility Agreement prior to such date. The Second Amendment also contained a waiver of
the defaults under the Deerfield Facility Agreement for the fixed charge coverage ratio for the month of January 2016.
In September 2016, in connection with the Globus Transaction, Deerfield exercised its right to convert all outstanding Initial
Warrants and Draw Warrants into shares of the Company's common stock based on the Black-Scholes value of the warrants. The
outstanding warrants were converted into 268,614 shares of the Company's common stock valued at $1.1 million.
On September 1, 2016, in connection with the Globus Transaction, the Company repaid in full all amounts outstanding and due
under the Deerfield Facility Agreement and terminated the Deerfield Facility Agreement. Pursuant to the Globus Facility Agreement
and the MidCap Fifth Amendment, the Company made a final payment of $33.5 million to Deerfield, consisting of outstanding
principal and accrued interest of $27.9 million, a prepayment premium of $5.6 million and other related fees and wrote-off $3.9
million of unamortized expenses resulting in a loss on debt extinguishment of $9.5 million.
Globus Facility Agreement
On September 1, 2016, the Company and Globus entered into the Globus Facility Agreement, pursuant to which Globus agreed
to loan the Company up to $30 million, subject to the terms and conditions set forth in the Globus Facility Agreement. At the closing
of the Globus Transaction, the Company made an initial draw of $25 million under the Globus Facility Agreement with an additional
draw of $5 million made in the fourth quarter of 2016. As of December 31, 2016, the outstanding balance under the Globus Facility
Agreement was $30.0 million, which becomes due and payable in quarterly payments of $0.8 million starting in September 2018, with
a final payment of the remaining amount outstanding due on September 1, 2021. The term loan interest rate is priced at LIBOR plus
8.0% through September 1, 2018, and LIBOR plus 13.0%, thereafter. At December 31, 2016, unamortized debt discount related to the
Globus Facility Agreement within the consolidated balance sheet was $1.0 million, which will be amortized over the remaining term
of the Globus Facility Agreement.
As collateral for the Globus Facility Agreement, the Company granted Globus a first lien security interest in substantially all of
its assets, other than accounts receivable and related assets, which will secure the Globus Facility Agreement on a second lien basis.
The Globus Facility Agreement includes traditional lending and reporting covenants including a liquidity calculation and a fixed
charge coverage ratio to be maintained by the Company that are consistent with the covenants under the Amended Credit Facility. The
financial covenants of the Globus Facility Agreement are not effective until April 2018 (See Note 15). There is no assurance that the
F-25
Company will be in compliance with the financial covenants of the Globus Facility Agreement in the future. The Globus Facility
Agreement also includes several event of default provisions, such as payment default, insolvency conditions and a material adverse
effect clause, which could cause interest to be charged at a rate which is up to five percentage points above the rate effective
immediately before the event of default or result in Globus’s right to declare all outstanding obligations immediately due and payable.
Other Debt Agreements
The Company has various capital lease arrangements. The leases bear annual interest at rates ranging from 6.6% to 9.6%, are
generally due in monthly principal and interest installments, are collateralized by the related equipment, and have various maturity
dates through September 2018.
Long-term debt consists of the following (in thousands):
$
Amended Credit Facility with MidCap
Facility Agreement with Deerfield
Globus Facility Agreement
Notes payable
Total
Add: capital leases (See Note 7)
Less: debt discount
Total
Less: current portion of long-term debt
Total long-term debt, net of current portion
$
Principal payments on debt are as follows as of December 31, 2016 (in thousands):
Year Ending December 31,
2017
2018
2019
2020
2021
Total
Add: capital lease principal payments
Less: debt discount
Total
Less: current portion of long-term debt
Long-term debt, net of current portion
December 31,
2016
2015
17,873 $
—
30,000
1,395
49,268
480
(3,543)
46,205
(3,113)
43,092 $
56,799
26,000
—
1,788
84,587
1,277
(5,642)
80,222
(79,742)
480
$
$
3,795
4,046
16,427
3,333
21,667
49,268
480
(3,543)
46,205
(3,113)
43,092
7. Commitments and Contingencies
Leases
In February 2008, the Company entered into a sublease agreement for office, engineering, and research and development space
in Carlsbad, California. The Sublease term commenced May 2008 and ended on January 31, 2016. In January 2016, the Company
entered into a new lease agreement (the “Building Lease”) for the same property with the lease term through July 31, 2021. Under the
new Building Lease the Company’s monthly rent payable is approximately $105,000 per month during the first year and increases by
approximately $3,000 per month each year thereafter.
The Company also leases certain equipment and vehicles under operating leases which expire on various dates through 2018,
and certain equipment under capital leases which expire on various dates through 2017.
F-26
Future minimum annual lease payments under the Company’s operating and capital leases are as follows (in thousands):
Year ending December 31,
2017
2018
2019
2020
2021
Thereafter
Less: amount representing interest
Present value of minimum lease payments
Current portion of capital leases
Capital leases, less current portion
Operating
$
1,589 $
1,557
1,544
1,585
971
—
7,246
$
Capital
437
68
—
—
—
—
505
(25)
480
(414)
66
Rent expense under operating leases for the years ended December 31, 2016, 2015 and 2014 was $2.1 million, $1.8 million and
$1.8 million, respectively.
Litigation
The Company is and may become involved in various legal proceedings arising from its business activities. While management
is not aware of any litigation matter that in and of itself would have a material adverse impact on the Company’s consolidated results
of operations, cash flows or financial position, litigation is inherently unpredictable, and depending on the nature and timing of a
proceeding, an unfavorable resolution could materially affect the Company’s future consolidated results of operations, cash flows or
financial position in a particular period. The Company assesses contingencies to determine the degree of probability and range of
possible loss for potential accrual or disclosure in our consolidated financial statements. An estimated loss contingency is accrued in
the Company’s consolidated financial statements if it is probable that a liability has been incurred and the amount of the loss can be
reasonably estimated. Because litigation is inherently unpredictable and unfavorable resolutions could occur, assessing contingencies
is highly subjective and requires judgments about future events. When evaluating contingencies, the Company may be unable to
provide a meaningful estimate due to a number of factors, including the procedural status of the matter in question, the presence of
complex or novel legal theories, and/or the ongoing discovery and development of information important to the matters. In addition,
damage amounts claimed in litigation against the Company may be unsupported, exaggerated or unrelated to reasonably possible
outcomes, and as such are not meaningful indicators of the Company’s potential liability.
Indemnifications
In the normal course of business, the Company enters into agreements under which it occasionally indemnifies third-parties for
intellectual property infringement claims or claims arising from breaches of representations or warranties. In addition, from time to
time, the Company provides indemnity protection to third-parties for claims relating to past performance arising from undisclosed
liabilities, product liabilities, environmental obligations, representations and warranties, and other claims. In these agreements, the
scope and amount of remedy, or the period in which claims can be made, may be limited. It is not possible to determine the maximum
potential amount of future payments, if any, due under these indemnities due to the conditional nature of the obligations and the
unique facts and circumstances involved in each agreement.
Royalties
The Company has entered into various intellectual property agreements requiring the payment of royalties based on the sale of
products that utilize such intellectual property. These royalties primarily relate to products sold by Alphatec Spine and are calculated
either as a percentage of net sales or in one instance on a per-unit sold basis. Royalties are included on the accompanying consolidated
statement of operations as a component of cost of revenues.
8. Orthotec Settlement
On September 26, 2014, the Company entered into a Settlement and Release Agreement, dated as of August 13, 2014, by and
among the Company and its direct subsidiaries, including Alphatec Spine, Inc., Alphatec Holdings International C.V., Scient'x S.A.S.
and Surgiview S.A.S.; HealthpointCapital, LLC, HealthpointCapital Partners, L.P., HealthpointCapital Partners II, L.P., John H.
Foster and Mortimer Berkowitz III; and Orthotec, LLC and Patrick Bertranou, (the “Settlement Agreement”). Pursuant to the
Settlement Agreement, the Company agreed to pay Orthotec, LLC $49.0 million in cash, including initial cash payments in totaling
F-27
$17.5 million, which the Company previously paid in 2014. The Company agreed to pay the remaining $31.5 million in 28 quarterly
installments of $1.1 million and one additional quarterly installment of $0.7 million, commencing October 1, 2014. In September
2014, the Company and HealthpointCapital entered into an agreement for joint payment of settlement whereby HealthpointCapital has
agreed to contribute $5 million to the $49 million settlement amount.
As of December 31, 2016, the Company has made installment payments in the aggregate of $27.4 million, with a remaining
unpaid balance of $30.4 million. The Company has the right to prepay the amounts due without penalty. In addition, the unpaid
balance of the amounts due accrues interest at the rate of 7% per year beginning May 15, 2014 until the amounts due are paid in full.
The accrued but unpaid interest will be paid in quarterly installments of $1.1 million (or the full amount of the accrued but unpaid
interest if less than $1.1 million) following the full payment of the $31.5 million in quarterly installments described above. No interest
will accrue on the accrued interest. The Settlement Agreement provided for mutual releases of all claims in the Orthotec, LLC v.
Surgiview, S.A.S, et al. matter in the Superior Court of California, Los Angeles County and all other related litigation matters
involving the Company and its directors and affiliates.
9. Redeemable Preferred Stock
The Company issued shares of redeemable preferred stock in connection with its initial public offering in June 2006. As of
December 31, 2016, the redeemable preferred stock carrying value was $23.6 million and there were 20 million shares of redeemable
preferred stock authorized. The redeemable preferred stock is not convertible into common stock but is redeemable at $9.00 per share,
(i) upon the Company’s liquidation, dissolution or winding up, or the occurrence of certain mergers, consolidations or sales of all or
substantially all of the Company’s assets, before any payment to the holders of the Company’s common stock, or (ii) at the
Company’s option at any time. Holders of redeemable preferred stock are generally not entitled to vote on matters submitted to the
stockholders, except with respect to certain matters that will affect them adversely as a class, and are not entitled to receive dividends.
The carrying value of the redeemable preferred stock was $7.11 per share at December 31, 2016 and 2015.
The redeemable preferred stock is presented separately from stockholders’ deficit in the consolidated balance sheets and any
adjustments to its carrying value up to its redemption value of $9.00 per share will be reported as a dividend.
10. Stock Benefit Plans, Stock-Based Compensation and Equity Transactions
In 2005, the Company adopted its 2005 Employee, Director, and Consultant Stock Plan (the “2005 Plan”). The 2005 Plan
expired in April 2016. As of December 31, 2016, there were 615,902 shares issuable under the 2005 Plan.
In the third quarter of 2016, the Company adopted its 2016 Equity Incentive Plan (the “2016 Plan”), which replaced the 2005
Plan. The 2016 Plan allows for the grant of options, restricted stock, restricted stock unit awards and performance unit awards to
employees, directors, and consultants of the Company. Upon its adoption, the 2016 Plan had 1,083,333 shares of common stock
reserved for issuance. The Board of Directors determines the terms of the grants made under the 2016 Plan. Options granted under the
2016 Plan expire no later than ten years from the date of grant (five years for incentive stock options granted to holders of more
than 10% of the Company’s voting stock). Options generally vest over a four year period and may be immediately exercisable upon a
change of control of the Company. The exercise price of incentive stock options may not be less than 100% of the fair value of the
Company’s common stock on the date of grant. The exercise price of any option granted to a 10% stockholder may be no less
than 110% of the fair value of the Company’s common stock on the date of grant. At December 31, 2016, 392,659 shares of common
stock remained available for issuance under the 2016 Plan. The 2016 Plan will expire in May 2026.
On October 4, 2016, the Company’s Board of Directors adopted the 2016 Employment Inducement Award Plan (the
“Inducement Plan”). The Inducement Plan allows for the grant of options, restricted stock, restricted stock unit awards and
performance unit awards to new employees of the Company by granting an award to such new employee as an inducement for such
new employee to begin employment with the Company. The Inducement Plan currently has 950,000 shares of common stock
reserved for issuance, which may only be granted to an employee who has not previously been an employee or member of the board of
directors of the Company. The terms of the Inducement Plan are substantially similar to the terms of the Company’s 2016 Plan with
two principal exceptions: (i) incentive stock options may not be granted under the Inducement Plan; and (ii) the annual compensation
paid by the Company to specified executives will be deductible only to the extent that it does not exceed $1.0 million. Under the
Inducement Plan, the Company granted $0.8 million of value Performance Restricted Share Units ("PRSUs"). The PRSUs will vest
in a dollar amount representing between 0% to 250% of the target value upon the earlier of September 14, 2019 or a change in control
of the Company. The actual payout amount will be based on the Company’s market capitalization on the vesting date and the fair-
market value of the Company’s common stock on such vesting date and will be paid in shares of the Company's common stock.
The 2005 Plan, the 2016 Plan and the Inducement Plan are cumulatively referred to as the Plans.
F-28
Stock Options
A summary of the Company’s stock option activity under the Plans and related information is as follows (in thousands, except
as indicated and per share data), as adjusted for the 1-for-12 reverse stock split:
Outstanding at December 31, 2015
Granted
Forfeited
Outstanding at December 31, 2016
Options vested and exercisable at December 31, 2016
Options vested and expected to vest at December 31, 2016
Weighted
average
exercise
price
Weighted
average
remaining
contractual
term
(in years)
Aggregate
intrinsic
value
24.96
4.43
29.42
12.17
21.11
13.37
6.36 $
—
—
7.75 $
5.20 $
7.41 $
—
—
—
—
—
—
Shares
637 $
668 $
(150) $
1,155 $
435 $
991 $
The weighted-average grant-date fair value per share of stock options granted during the years ended December 31, 2016, 2015
and 2014 was $4.43, $15.36 and $9.72, respectively. The aggregate intrinsic value of options at December 31, 2016 is based on the
Company’s closing stock price on that date of $3.21 per share.
As of December 31, 2016, there was $5.6 million of unrecognized compensation expense for stock options and awards which is
expected to be recognized on a straight-line basis over a weighted average period of approximately 3.6 years. The total intrinsic value
of options exercised was immaterial for the years ended December 31, 2016, 2015 and 2014.
Restricted Stock Awards and Units
The following table summarizes information about the restricted stock awards, restricted stock units and performance-based
restricted units activity (in thousands, except as indicated and per share data), as adjusted for the 1-for-12 reverse stock split:
Unvested at December 31, 2015
Awarded
Vested
Forfeited
Unvested at December 31, 2016
Weighted
average
grant
date fair
value
Weighted
average
remaining
recognition
period
(in years)
16.91
5.79
9.73
16.65
7.48
1.48
3.02
Shares
260 $
969 $
(64) $
(73) $
1,092 $
The weighted average fair value per share of awards granted during the years ended December 31, 2016, 2015 and 2014 was
$5.79, $16.11 and $16.62 respectively.
Performance-Based Restricted Stock Units
In July 2014, the Company granted 77,666 performance-based restricted stock units ("PSUs") to certain employees under its
2005 Plan. The PSUs vest based upon the Company's achievement of certain performance goals over the period from July 1, 2014
through December 31, 2016. The number of PSUs that may vest varies between 0%-200% based on the achievement of such goals.
The PSUs were valued at $17.04 per share based on the closing price of the Company's common stock on the date of grant. The
performance criteria for the PSUs issued in 2014 was not met and they were cancelled in 2017.
In February 2015, the Company granted 154,500 PSUs to certain employees under its 2005 Plan. The PSUs vest based upon the
Company's achievement of certain performance goals over the period from January 1, 2015 through December 31, 2017. The number
of PSUs that may vest varies between 0%-200% based on the achievement of such goals. The PSUs were valued at $16.20 per share
based on the closing price of the Company's common stock on the date of grant.
F-29
For purposes of measuring compensation expense, the amount of PSUs ultimately expected to vest is estimated at each reporting
date based on management’s expectations regarding the relevant performance criteria. The related compensation expense was $0.0
million, $0.2 million and $0.2 million for the years ended December 31, 2016, 2015 and 2014, respectively. The recognition of
compensation expense associated with PSUs requires judgment in assessing the probability of meeting the performance goals, as well
as defined criteria for assessing achievement of the performance-related goals.
Elite Medical Holdings and Pac 3 Surgical Collaboration Agreement
In October 2013, the Company entered into a three-year collaboration agreement with Elite Medical Holdings, LLC and Pac 3
Surgical Products, LLC (the "Collaborators") (the "Collaboration Agreement") to provide consultation services to assist the Company
in the development of its products and its products in development. Under the terms of the collaboration agreement, the Company will
gain exclusive rights to the use of all intellectual property developed by the collaborators. The Company agreed to make three annual
payments to the collaborator as sole consideration for services provided, totaling an aggregate of up to $8 million, paid in common
stock of Alphatec Holdings at a per share price of $23.35, which was equal to the average NASDAQ closing price of the common
stock on the five days leading up to and including the date of signing the Collaboration Agreement. The actual number of shares
issued each year will be determined by the fair market value of the services provided over the prior 12 months.
On November 2, 2015, the Company entered into a first amendment (the "First Amendment") to the Collaboration Agreement.
Pursuant to the First Amendment, in exchange for a "lock up" restriction on selling or transferring each tranche of shares issued to the
Collaborators and a maximum value cap, as discussed below, the Company has agreed to make a cash payment to the Collaborators in
the event that the shares in such tranche do not have a minimum amount of value based on the market value of the Company’s
common stock at the end of the lock up period applicable to such tranche of shares. In addition, in the event that at the end of a lock up
period the value of a tranche of shares issued to the Collaborators exceeds a certain amount, the Collaborators have agreed to forfeit
shares back to the Company, so as to limit the maximum amount of value derived from such shares at the end of a lock up period.
Pursuant to the First Amendment, the shares issued to the Collaborators in each of 2014, 2015 and 2016 are subject to a lock up that
lasts until the first quarter of 2017, 2018 and 2019, respectively. The valuation of each tranche of shares occurs at the end of the
applicable lock up period.
Based on the closing price of the Company’s common stock on December 31, 2016, the Company has recorded a guaranteed
compensation liability of $6.7 million for shares of the Company’s common stock previously issued under the Collaboration
Agreement, with $2.2 million payable in 2017, 2018 and 2019. The amount payable in 2017 is included in accrued expenses and the
amounts payable in 2018 and 2019 are presented under other long-term liabilities in the consolidated balance sheet and represent the
cash settlement amounts. If the Collaborators elect to sell, assign or transfer: (i) more than 20% of the shares issued to the
Collaborators prior to the first valuation date; or (ii) any of the Collaborator shares still subject to a lockup after the first valuation
date, all of the aforementioned restrictions on transfer and valuation minimums and maximums are null and void.
As of December 31, 2016, the Company has issued 342,356 shares of its common stock under this agreement and recorded
expense of $2.1 million, $4.9 million and $1.9 million in the years ended December 31, 2016, 2015 and 2014, respectively, which is
included in research and development expenses.
SVB Warrants
In December 2011, in connection with the third amendment to the Company’s former credit facility with the SiliconValley Bank
("SVB"), finance charges totaling $0.2 million were waived in exchange for the issuance to SVB of warrants to purchase 7,812 shares
of the Company’s common stock. The warrants are immediately exercisable, can be exercised through a cashless exercise, have an
exercise price of $19.20 per share and have a 10-year term.
Common Stock Reserved for Future Issuance
Common stock reserved for future issuance consists of the following (in thousands), as adjusted for the 1-for-12 reverse stock
split:
Stock options outstanding
Awards outstanding
Warrants outstanding
Authorized for future grant under 2016 and INDC Plans
December 31, 2016
1,155
1,092
8
395
2,650
F-30
11. Income Taxes
The components of the pretax income (loss) from continuing operations for the years ended December 31, 2016, 2015 and 2014
are as follows (in thousands):
U.S. Domestic
Foreign
Pretax income (loss) from operations
Year Ended December 31,
2015
(88,614) $
(83,785)
(172,399) $
2016
(29,898) $
(1,037)
(30,935) $
2014
(3,821)
4,130
309
$
$
The components of the (benefit) provision for income taxes from continuing operations are presented in the following table (in
thousands):
Current income tax (benefit) provision:
Federal
State
Total current
Deferred income tax (benefit) expense:
Federal
State
Total deferred
Total income tax (benefit) provision
Year Ended December 31,
2015
2014
2016
$
$
(8) $
72
64
221 $
149
370
(4,269)
(429)
(4,698)
(4,634) $
(1,363)
(153)
(1,516)
(1,146) $
—
145
145
238
24
262
407
ASC 740-20 requires total income tax expense or benefit to be allocated among continuing operations, discontinued operations,
extraordinary items, other comprehensive income and items charged directly to shareholders’ equity. This allocation is referred to as
intra-period tax allocation. The sale of the Company's international distribution operations and several foreign subsidiaries is reported
under discontinued operations in the consolidated financial statements. Accordingly, we are required to allocate the provision for
income taxes between continuing operations and discontinued operations. For the year ended December 31, 2016, we recognized a
gain from discontinued operations before tax, and, as a result, we recorded a tax expense of $6.5 million in discontinued operations
and a corresponding tax benefit to continuing operations.
The provision for income taxes differs from the amount of income tax determined by applying the applicable U.S. statutory
federal income tax rate to pretax income (loss) from continuing operations as a result of the following differences:
Federal statutory rate
Adjustments for tax effects of:
State taxes, net
Stock-based compensation
Foreign taxes
Tax credits
Deemed foreign dividend
Fair market value adjustments
Intercompany debt forgiveness and other permanent
adjustments
Goodwill impairment
Tax rate adjustment
Uncertain tax positions
Other
Valuation allowance
Effective income tax rate
2016
December 31,
2015
2014
(35.0)%
(35.0)%
(35.0)%
(1.7)%
2.3%
0.1%
—
—
0.4%
0.3%
—
0.3%
(0.1)%
0.9%
17.5%
(15.0)%
(0.3)%
0.4%
0.1%
(0.1)%
0.1%
(1.6)%
0.1%
30.5%
0.3%
—
(4.3)%
9.1%
(0.7)%
(3.9)%
(239.7)%
(17.2)%
123.3%
—
293.4%
(29.9)%
—
(16.3)%
(54.0)%
913.2%
(1,065.6)%
(131.7)%
The 2016 benefit for income taxes from continuing operations primarily consists of domestic losses net of state taxes.
F-31
Significant components of the Company’s deferred tax assets and liabilities as of December 31, 2016 and 2015 are as follows
(in thousands):
Deferred tax assets:
Allowances and reserves
Accrued expenses
Inventory reserves
Net operating loss carryforwards
Property and equipment
Intangible asset
Stock-based compensation
Legal settlement
Goodwill
Income tax credit carryforwards
Total deferred tax assets
Valuation allowance
Total deferred tax assets, net of valuation allowance
Deferred tax liabilities:
Investment in foreign partnership
Intangible assets
Total deferred tax liabilities
Net deferred tax assets (liabilities)
December 31,
2016
2015
$
$
705 $
1,452
7,071
37,444
2,730
3,291
1,766
11,494
3,029
5,429
74,411
(58,202)
16,209
16,215
—
16,215
(6) $
955
2,331
9,631
43,427
2,420
—
2,377
11,806
3,362
3,235
79,544
(63,612)
15,932
15,467
465
15,932
—
The realization of deferred tax assets is dependent on the Company’s ability to generate sufficient taxable income in future years
in the associated jurisdiction to which the deferred tax assets relate. As of December 31, 2016, a valuation allowance of $58.2 million
has been established against the net deferred tax assets as realization is uncertain. The deferred tax liabilities consist primarily of the
excess of the book value over the tax basis of their investment in the foreign partnership.
In determining the need for a valuation allowance, the Company considers all available positive and negative evidence,
including scheduled reversals of deferred tax liabilities, projected future taxable income, tax planning strategies, and recent financial
performance. Based on the review of all positive and negative evidence, including a three year cumulative pre-tax loss, the Company
determined that a full valuation allowance should be recorded against all U.S. deferred tax assets and all European deferred tax assets,
except for Scient'x S.A.S. and Surgiview S.A.S. at December 31, 2016, as the French entities now have an overall net deferred tax
liability. If the Company later determines that it is more-likely-than-not to realize all or a portion of the U.S. or other European
deferred tax assets, it would reverse the previously provided valuation allowance.
At December 31, 2016, the Company has unrecognized tax benefits of $9.3 million of which $7.9 million will affect the
effective tax rate if recognized when the Company no longer has a valuation allowance offsetting its deferred tax assets.
The following table summarizes the changes to unrecognized tax benefits for the years ended December 31, 2016, 2015 and
2014 (in thousands):
Unrecognized tax benefit at the beginning of the year
Additions based on tax positions related to the
current year
Additions based on tax positions related to the prior year
Reductions as a result of lapse of applicable statute
of limitations
Reductions as a result of foreign exchange rates and other
$
Unrecognized tax benefits at the end of the year
Year ended December 31,
2015
2014
2016
10,359
8,861
7,835
153
57
859
1,144
(184)
(1,054)
9,331 $
(76)
(429)
10,359 $
1,050
391
(40)
(375)
8,861
The Company believes it is reasonably possible it will reduce its unrecognized tax benefits by $0.6 million within the next 12
months.
F-32
The Company and its subsidiaries are subject to federal income tax as well as income tax of multiple state and foreign
jurisdictions. With few exceptions, the Company is no longer subject to income tax examination by tax authorities in major
jurisdictions for years prior to 2011. However, to the extent allowed by law, the taxing authorities may have the right to examine prior
periods where net operating losses and tax credits were generated and carried forward, and make adjustments up to the amount of the
carryforwards. The Company is not currently under examination by the Internal Revenue Service, foreign or state and local tax
authorities, however Scient’x’s 2013 and 2014 tax years are currently under audit by the French tax authorities.
The Company recognizes interest and penalties related to uncertain tax positions as a component of the income tax provision. As
of December 31, 2016, accrued interest and penalties were $1.1 million, which primarily relates to the uncertain tax positions of the
Scient’x operations. During 2016, there was a decrease of $0.1 million in the accrued interest and penalties related to the uncertain tax
positions of the Scient’x operations.
At December 31, 2016, the Company had federal and state net operating loss carryforwards of $91.9 million and $113.9 million,
respectively, expiring at various dates through 2036. At December 31, 2016, the Company had federal and state research and
development tax credits of $3.4 million and $3.1 million, respectively. The federal research and development tax credits expire at
various dates through 2036, while the state credits do not expire. The Company had foreign net operating loss carryforwards of $14.9
million which do not expire. Utilization of the net operating loss and tax credit carryforwards may become subject to annual
limitations due to ownership change limitations that could occur in the future as provided by Section 382 of the Internal Revenue
Code of 1986, as amended (the “Internal Revenue Code”), as well as similar state and foreign provisions. These ownership changes
may limit the amount of the net operating loss and tax credit carryforwards that can be utilized annually to offset future taxable
income.
The Company does not record U.S. income taxes on the undistributed earnings of its foreign subsidiaries based upon the
Company’s intention to permanently reinvest undistributed earnings to ensure sufficient working capital and further expansion of
existing operations outside the United States. The undistributed earnings of the foreign subsidiaries as of December 31, 2016 are
immaterial. In the event the Company is required to repatriate funds from outside of the United States, such repatriation would be
subject to local laws, customs, and tax consequences. Determination of the amount of unrecognized deferred tax liability related to
these earnings is not practicable.
12. Related Party Transactions
For the years ended December 31, 2016, 2015 and 2014, the Company incurred costs of less than $0.1 million, $0.1 million and
$0.2 million, respectively, to Foster Management Company and HealthpointCapital, LLC for travel and administrative expenses. John
H. Foster, who was one of the Company's directors until March 2, 2016 is a significant equity holder of HealthpointCapital, LLC, an
affiliate of HealthpointCapital Partners, L.P. and HealthpointCapital Partners II, L.P., which are the Company’s principal
stockholders. As of December 31, 2016, the Company also had a liability of less than $0.1 million payable to HealthpointCapital,
LLC for travel and administrative expenses.
In July 2016, the Company entered into a forbearance agreement with HealthpointCapital, LLC, HealthpointCapital Partners,
L.P., and HealthpointCapital Partners II, L.P. (collectively, "HealthpointCapital"), pursuant to which HealthpointCapital, on behalf of
the Company, paid $1.0 million of the $1.1 million payment due and payable by the Company to Orthotec on July 1, 2016 and agreed
to not exercise its contractual rights to seek an immediate repayment of such amount. Pursuant to this forbearance agreement, the
Company repaid this amount in September 2016. The Company and HealthpointCapital entered into an agreement for joint payment
of settlement whereby HealthpointCapital has agreed to contribute $5 million to the $49 million settlement amount.
Indemnification Agreements
The Company has entered into indemnification agreements with certain of its directors, which are named defendants in the
Orthotec litigation matter in New York (See Note 8). The indemnification agreements require the Company to indemnify these
individuals to the fullest extent permitted by applicable law and to advance expenses incurred by them in connection with any
proceeding against them with respect to which they may be entitled to indemnification by the Company. For the years ended
December 31, 2016, 2015 and 2014, the Company paid less than $0.1 million in each year in connection with the indemnification
obligations of Scient’x and Surgiview, all of which was related to the Orthotec matter. (See Note 8).
F-33
13. Retirement Plan
The Company maintains an employee savings plan that qualifies as a deferred salary arrangement under Section 401(k) of the
Internal Revenue Code. Under the savings plan, participating employees may contribute a portion of their pre-tax earnings, up to the
Internal Revenue Service annual contribution limit. Additionally, the Company may elect to make matching contributions into the
savings plan at its sole discretion of up to 4% of each individual’s compensation. Matching contributions vest after one year of
service. The Company’s total contributions to the 401(k) plan were $0.4 million, $0.6 million and $0.6 million for the years ended
December 31, 2016, 2015 and 2014, respectively.
14. Restructuring Activities
In connection with the Globus Transaction (described in Note 4), the Company reduced its U.S. workforce and terminated
employment agreements with several executive officers and employees including the chief executive officer and the chief financial
officer, and recorded restructuring expenses related to severance and post-employment benefits of $1.9 million in the year ended
December 31, 2016. The Company had additional headcount reductions in February 2017.
On July 6, 2015, the Company announced a restructuring of its manufacturing operations in California in an effort to improve its
cost structure. The restructuring includes a reduction in workforce and closing the California manufacturing facility. Restructuring
liabilities are measured at fair value and recognized as incurred. The Company incurred termination benefits, accelerated
depreciation, facility closing and other restructuring costs expenses of $0.4 million and $2.2 million in the years ended December 31,
2016 and 2015, respectively, related to these restructuring activities which were completed in the first half of 2016.
In 2013, the Company announced that Scient'x began a process to significantly restructure its business operations in France in
an effort to improve operating efficiencies and rationalize its cost structure and in 2015 the Company initiated plans to close its French
operations. The restructuring included a reduction in Scient'x's workforce and closing of the manufacturing facilities in France. The
Company has recorded total costs of $10.6 million through December 31, 2016, which includes employee severance, social plan
benefits and related taxes, facility closing costs, manufacturing transfer costs, and contract termination costs. The Company has
substantially completed the activities associated with the restructuring as of December 31, 2016, and majority of the related liabilities
have been settled.
15. Subsequent Event
On March 22, 2017, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with certain
institutional and accredited investors (collectively, the “Purchasers”), including certain directors and executive officers of the
Company, providing for the sale by the Company of 1,809,628 shares of its common stock at a purchase price of $2.00 per share,
15,245 shares of preferred shares (the “Preferred Shares,”) and a newly designated Series A Convertible Preferred Stock (the “Series
A Convertible Preferred Stock”) at a purchase price of $1,000 per share (which Preferred Shares are convertible into approximately
7,622,372 shares of the Company’s common stock, subject to limitations on conversion until the approval by the Company’s
stockholders and warrants to purchase up to 9,432,000 shares of its Common Stock at an exercise price of $2.00 per share (the
“Warrants”), in a private placement (the “Private Placement”). The Warrants will become exercisable following stockholder approval,
are subject to certain ownership limitations, and expire five years after the date of such stockholder approval.
The aggregate gross proceeds for the Private Placement is approximately $18.9 million. The Company intends to use the net
proceeds from the Private Placement for general corporate and working capital purposes. Certain directors and executive officers of
the Company purchased an aggregate of $2.35 million of shares of Series A Convertible Preferred Stock, which shares are convertible
into approximately 1,175,000 shares of Common Stock, and Warrants to purchase up to 1,175,000 shares of the Company’s common
stock. Pursuant to the terms of the Purchase Agreement, from the closing until the later of 90 days after the effective date of a resale
registration statement or the date of stockholder approval, the Company is prohibited from issuing, or entering into any agreement to
issue, or announcing the issuance or proposed issuance of, any shares of the Company’s common stock or common stock equivalents,
subject to certain permitted exceptions.
A total of 15,245 shares of Series A Convertible Preferred Stock will be authorized for issuance under a Certificate of
Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock of the Company (the “Certificate of
Designation”), to be filed with the Secretary of State of the State of Delaware in connection with the closing. The shares of Series A
Convertible Preferred Stock have a stated value of $1,000 per share and will be convertible into approximately 500 shares of the
Company’s common stock. Until the date that stockholder approval is obtained, the Certificate of Designation limits the number of
shares of common stock issuable upon conversion of the Series A Convertible Preferred Stock such that, when aggregated with the
shares of common stock issued at the closing, such issuances shall not exceed 19.99% of the Company’s issued and outstanding
common stock.
F-34
The Series A Convertible Preferred Stock will be entitled to dividends on an as-if-converted basis in the same form as any
dividends actually paid on shares of the Company’s common stock or other securities. The initial conversion price of $2.00 is subject
to appropriate adjustment in the event of a stock split, stock dividend, combination, reclassification or other recapitalization affecting
the Company’s common stock. In addition, for a period ending on the earlier of one year from effective date of a resale registration
Statement or the date on which there are no shares of Series A Convertible Preferred Stock outstanding, the conversion price is also
subject to full ratchet anti-dilution protection in the event the Company issues securities at an effective price less than the initial
conversion price, subject to certain exceptions.
On March 30, 2017, the Company entered into a sixth amendment to the Amended Credit Facility with MidCap and a first
amendment to the Globus Facility Agreement with Globus (collectively the “2017 Amendments). The 2017 Amendments extend the
date that the financial covenants of the Amended Credit Facility and the Globus Facility Agreement are effective from April 2017 to
April 2018.
16. Quarterly Financial Data (Unaudited)
The following financial information reflects all normal recurring adjustments, which are, in the opinion of management,
necessary for a fair statement of the results of the interim periods. Summarized quarterly data for fiscal 2016 and 2015 are as follows
(in thousands, except per share data):
Selected quarterly financial data: (2)
Revenue
Gross profit
Total operating expenses
Loss from continuing operations
Income (loss) from discontinued operations
Net loss
Net loss per basic and diluted share (1)
Selected quarterly financial data: (2)
Revenue
Gross profit
Total operating expenses
Loss from continuing operations
Income (loss) from discontinued operations
Net loss
Net loss per basic and diluted share (1)
$
$
Year ended December 31, 2016
1st
Quarter
2nd
Quarter
3rd
Quarter
4th
Quarter
34,206 $
24,487
27,930
(4,248)
(2,369)
(6,617)
(0.78)
32,241 $
21,158
21,479
(1,909)
(3,324)
(5,233)
(0.62)
26,711 $
15,862
20,411
(10,063)
(3,658)
(13,721)
(1.60)
27,090
14,627
21,691
(10,081)
5,727
(4,354)
(0.49)
Year ended December 31, 2015
1st
Quarter
2nd
Quarter
3rd
Quarter
4th
Quarter
35,577 $
24,492
24,750
(3,599)
(963)
(4,561)
(0.55)
32,333 $
18,287
23,691
(4,190)
243
(3,947)
(0.48)
31,687 $
21,658
186,333
(156,998)
(3,267)
(160,265)
(19.35)
34,791
23,585
29,103
(6,463)
(3,440)
(9,903)
(1.18)
(1) Basic and diluted net loss per share, adjusted for the 1-for-12 reverse stock split, is computed independently for each of the
quarters presented. Therefore, the sum of the quarterly per share amounts will not necessarily equal the total for the year.
(2)
Selected quarterly financial data for periods prior to the nine months ended September 30, 2016 have been recast to reflect
discontinued operations.
F-35
SCHEDULE II—VALUATION AND QUALIFYING ACCOUNTS
Balance at December 31, 2013
Provision
Write-offs and recoveries, net
Balance at December 31, 2014
Provision
Write-offs and recoveries, net
Balance at December 31, 2015
Provision
Write-offs and recoveries, net
Balance at December 31, 2016
(1)
The provision is included in sales and marketing expenses.
Allowance
for
Doubtful
Accounts (1)
(In thousands)
637
522
(613)
546
414
(191)
769
620
(31)
1,358
$
$
F-36
COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN*
Among Alphatec Holdings, Inc, the NASDAQ Composite Index
and the NASDAQ Medical Equipment Index
$250
$200
$150
$100
$50
$0
12/11
12/12
12/13
12/14
12/15
12/16
Alphatec Holdings, Inc
NASDAQ Composite
NASDAQ Medical Equipment
*$100 invested on 12/31/11 in stock or index, including reinvestment of dividends.
Fiscal year ending December 31.
Graph produced by Research Data Group, Inc.
1/5/17
EXECUTIVE TEAM
Terry M. Rich
Chief Executive Officer, Director
Mike Plunkett
President and Chief Operating Officer
CORPORATE HEADQUARTERS
Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, CA 92008
760.494.6610
www.alphatecspine.com
Jeff Black
Executive Vice President & Chief Financial Officer
ANNUAL MEETING OF STOCKHOLDERS
Thursday, June 15, 2017 at 2:00 p.m.
Corporate Headquarters
Craig Hunsaker
Executive Vice President, People & Culture
and General Counsel
COMMON STOCK LISTING
Nasdaq Global Select Market
Ticker Symbol: ATEC
Jon Allen
Executive Vice President, Commercial Operations
Brian Snider
Executive Vice President, Strategic Marketing and Product
Development
STOCK TRANSFER AGENT
Computershare, Inc.
480 Washington Blvd.
Jersey City, NJ 07310
Shareholder Communication Center: 800.356.2017
www.computershare.com
BOARD OF DIRECTORS
Mortimer “Tim” Berkowitz III
Chairman of the Board of Directors
R. Ian Molson
Director, Member of the Audit Committee,
Chair of the Compensation Committee
Stephen O’Neil
Director, Member of the Compensation Committee
Donald A. Williams
Director, Chair of the Audit Committee
David H. Mowry
Director, Member of the Audit Committee
Leslie H. Cross
Director
Terry M. Rich
Director, Chief Executive Officer
INDEPENDENT AUDITORS
Ernst & Young LLP
4370 La Jolla Village Drive
Suite 500
San Diego, CA 92122
www.ey.com
SECURITIES COUNSEL
Latham & Watkins LLP
12670 High Bluff Drive
San Diego, CA 92130
858.523.5400
www.lw.com
ANNUAL REPORT ON FORM 10-K
A copy of Alphatec Holdings, Inc. annual report to the
U.S. Securities and Exchange Commission on Form 10-K
is available without charge online at
www.alphatecspine.com
NOTE ON FORWARD LOOKING STATEMENTS
This annual report contains forward-looking statements
within the meaning of the United States securities laws.
Such forward-looking statements are subject to risks and
uncertainties that could cause Alphatec Holdings, Inc.’s
actual results to differ materially from those indicated
by these forward-looking statement. Information on
the risks and uncertainties that could affect Alphatec
Holdings, Inc.’s results is included in the Annual Report
on Form 10-K included herewith, Alphatec Holdings, Inc.
undertakes no obligation to update any forward-looking
statements.
5818 El Camino Real Carlsbad, CA 92008 USA
alphatecspine.com