NuVasive, Inc.
PROSPECTUS
Filed
pursuant to Rule 424(b)(1)
Registration No. 333-138047
401,956 Shares
Common Stock
This prospectus may be used only in connection with the resale, from time to time, by the
selling stockholder identified in this prospectus, of up to 401,956 shares of our common stock,
originally issued in September 2006 in connection with our buyout of all of our current and future
milestone and royalty obligations related to our acquisition of assets and technology from
Pearsalls Limited in August 2005. The selling stockholder may offer and sell its shares in public
or private transactions, or both. These sales may occur at fixed prices, at market prices
prevailing at the time of sale, at prices related to prevailing market prices, or at negotiated
prices.
The selling stockholder may sell shares to or through underwriters, broker-dealers or agents,
who may receive compensation in the form of discounts, concessions or commissions from the selling
stockholder, the purchasers of the shares, or both. See Plan of Distribution for a more complete
description of the ways in which the shares may be sold. We will not receive any of the proceeds
from the sale of the shares by the selling stockholder.
Our
common stock is quoted on the NASDAQ Global Market under the symbol
NUVA. On October 27, 2006, the last reported sale
price of our common stock on the NASDAQ Global Market was $23.65.
Investing in our common stock involves a high degree of risk. See Risk Factors beginning on
page 2 of this prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
The date
of this prospectus is October 31, 2006.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus relates to the resale of up to 401,956 shares of our common stock by the
selling stockholder. The shares were issued to the selling stockholder in September 2006 in
connection with our buyout of all of our current and future milestone and royalty obligations
related to our acquisition of assets and technology from Pearsalls Limited in August 2005. We will
not receive any proceeds from the potential sale of the shares offered by the selling stockholder.
This prospectus constitutes part of the registration statement on Form S-3 filed with the
Securities and Exchange Commission under the Securities Act of 1933, as amended (the Securities
Act), utilizing a shelf registration or continuous offering process. It omits some of the
information contained in the registration statement and reference is made to the registration
statement for further information with respect to us and the securities being offered by the
selling stockholder. Any statement contained in the prospectus concerning the provisions of any
document filed as an exhibit to the registration statement or otherwise filed with the Securities
and Exchange Commission is not necessarily complete, and in each instance, reference is made to the
copy of the document filed.
You should rely only on information contained in or incorporated by reference in this
prospectus. We have not authorized anyone to provide you with information that is different. If
anyone provides you with different or inconsistent information, you should not rely on it. These
securities will not be sold in any jurisdiction where such sale is not permitted. The information
contained in this prospectus is accurate only as of the date of this prospectus or earlier dates as
specified herein. Our business, financial condition, results of operations and prospects may have
changed since those dates.
This prospectus provides you with a general description of the common stock that will be sold
pursuant to this prospectus. The registration statement filed with the Securities and Exchange
Commission includes exhibits that provide more details about the matters discussed in this
prospectus. You should read this prospectus and the related exhibits filed with the Securities and
Exchange Commission, together with the additional information described under Where You Can Find
More Information.
Our business was incorporated in Delaware in July 1997. Our principal executive offices are
located at 4545 Towne Centre Court, San Diego, California, 92121, and our telephone number is (858)
909-1800. Our website is located at www.nuvasive.com. The information contained in, or that can
be accessed through, our website is not part of this prospectus. Unless the context requires
otherwise, as used in this prospectus the terms NuVasive, we, us, and our refer to
NuVasive, Inc., a Delaware corporation.
RISK FACTORS
An investment in our common stock involves a high degree of risk. You should carefully
consider the risks and uncertainties described below together with all other information contained
or incorporated by reference in this prospects before you decide to invest in our common stock. If
any of the following risks actually occurs, our business, financial condition, or results of
operations could suffer. In that case, the trading price of our common stock could decline, and
you may lose all or part of your investment.
Risks Related to Our Business and Industry
Our failure to build and maintain an effective and dedicated distribution network for our products
could significantly impair our ability to increase sales of our products.
We have only been selling our products since 2001. In the second quarter of 2006, we
completed our efforts to transition our sales force to one that is exclusive to us with respect to
the sale of spine products. We currently sell a significant majority of our products in the United
States through an exclusive sales force comprised of a network of independent distributors and
sales representatives managed by our directly-employed Area Business Managers. As a result, we are
dependent upon the sales and marketing efforts of third-parties. We pay these distributors
and sales representatives a commission based on their product sales. We believe having an
exclusive sales force is important in increasing our product sales as exclusivity brings greater
focus from sales agents and a greater
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commitment to generate sales of our full product line. Our transition to an exclusive sales
force has required us to offer higher commissions, sometimes for extended periods of time. As a
result, we expect to continue to incur significantly increased expenses through the end of 2006,
which may negatively impact our results of operations.
In connection with our efforts to build a dedicated sales force, we have hired and expect to
continue to hire sales representatives who work directly for us. We have little experience in
establishing and managing a direct sales force, so there is a risk that this sales force will not
succeed in growing sales of our products. Although we believe the cost of a direct sales force
will be comparable to that of independent agents, there is also a risk that the cost may turn out
to be higher.
Developing and maintaining a broader and more dedicated distribution network and sales force
is expensive and time consuming. Because of the intense competition for their services, we may be
unable to identify additional qualified sales representatives and independent sales agencies.
Further, we may not be able to enter into agreements with them on commercially reasonable terms, if
at all. Even if we do enter into agreements with additional sales representatives and/or
independent sales agencies, these parties may not be successful in marketing and selling our
products. Our business, financial condition and results of operations will be adversely affected
if the marketing and sales efforts of our direct sales representatives and independent sales
agencies are unsuccessful.
Pricing pressure from our competitors and sources of medical reimbursement may impact our ability
to sell our products at prices necessary to expand our operations and reach profitability.
The market for spine surgery products is large and growing at a significant rate. This has
attracted numerous new companies and technologies, and encouraged more established companies to
intensify competitive pressure. New entrants to our markets include companies owned partially by
spine surgeons, who have significant market knowledge and access to the surgeons who use our
products. As a result of this increased competition, we believe there will be growing pricing
pressure in the near future. If competitive forces drive down the price we are able to charge for
our products, our profit margins will shrink, which will hamper our ability to invest in and grow
our business.
Further, successful sales of our products will depend on the availability of adequate
reimbursement from third-party payors. Healthcare providers, such as hospitals that purchase
medical devices for treatment of their patients, generally rely on third-party payors to reimburse
all or part of the costs and fees associated with the procedures performed with these devices.
Spine surgeons are unlikely to use our products if they do not receive reimbursement adequate to
cover the cost of their involvement in the surgical procedures. We also believe that future
reimbursement may be subject to increased restrictions both in the United States and in
international markets. Future legislation, regulation or reimbursement policies of third-party
payors may adversely affect the demand for our existing products or our products currently under
development and limit our ability to sell our products on a profitable basis.
To the extent we sell our products internationally, market acceptance may depend, in part,
upon the availability of reimbursement within prevailing healthcare payment systems. Reimbursement
and healthcare payment systems in international markets vary significantly by country, and include
both government sponsored healthcare and private insurance.
We are in a highly competitive market segment and face competition from large, well-established
medical device manufacturers as well as new market entrants.
The market for spine surgery products and procedures is intensely competitive, subject to
rapid change and significantly affected by new product introductions and other market activities of
industry participants. With respect to NeuroVision, our nerve avoidance system, we compete with
Medtronic Sofamor Danek, Inc., a wholly owned subsidiary of Medtronic, Inc., and Nicolet
Biomedical, a VIASYS Healthcare company, both of which have significantly greater resources than we
do. With respect to MaXcess, our minimally disruptive surgical system, our largest competitors are
Medtronic Sofamor Danek, Inc., DePuy Spine, Inc., a Johnson & Johnson company, and Synthes-Stratec,
Inc. We compete with many of the same companies with respect to our other products. At any time,
these companies may develop alternative treatments, products or procedures for the treatment of
spine disorders that compete directly or indirectly with our products. Many of our larger
competitors are either publicly
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traded or divisions or subsidiaries of publicly traded companies, and enjoy several
competitive advantages over us, including:
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significantly greater name recognition; |
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established relations with spine surgeons, hospitals, other healthcare providers and third-party payors; |
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large and established distribution networks with significant international presence; |
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products supported by long-term clinical data; |
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greater experience in obtaining and maintaining United States Food and Drug
Administration, or FDA, and other regulatory approvals or clearances for products and
product enhancements; |
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more expansive portfolios of intellectual property rights; and |
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greater financial and other resources for product research and development, sales and
marketing and litigation. |
In addition, the spine industry is becoming increasingly crowded with new market entrants,
including companies owned at least partially by spine surgeons. Many of these new competitors
focus on a specific product or market segment, making it more difficult for us to increase our
overall market position. If these companies become successful, we expect that competition will
become even more intense, leading to greater pricing pressure and making it more difficult for us
to expand.
To be commercially successful, we must convince spine surgeons that our products are an attractive
alternative to existing surgical treatments of spine disorders.
We believe spine surgeons may not widely adopt our products unless they determine, based on
experience, clinical data and published peer reviewed journal articles, our products provide
benefits or an attractive alternative to conventional modalities of treating spine disorders.
Surgeons may be slow to change their medical treatment practices for the following reasons, among
others:
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lack of experience with our products; |
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lack of evidence supporting additional patient benefits; |
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perceived liability risks generally associated with the use of new products and procedures; |
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availability of reimbursement within healthcare payment systems; |
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costs associated with the purchase of new products and equipment; and |
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the time that must be dedicated for training. |
In addition, we believe recommendations and support of our products by influential surgeons
are essential for market acceptance and adoption. If we do not receive support from such surgeons
or from long-term data, surgeons and hospitals may not use our products. In such circumstances, we
may not achieve expected revenues and may never become profitable.
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Our future success depends on our ability to timely develop and introduce new products or product
enhancements that will be accepted by the market.
It is important to our business that we continue to build a more complete product offering to
surgeons and hospitals. As such, our success will depend in part on our ability to develop and
introduce new products and enhancements to our existing products to keep pace with the rapidly
changing spine market. We cannot assure you that we will be able to successfully develop, obtain
regulatory approval for or market new products or that any of our future products will be accepted
by the surgeons who use our products or the payors who financially support many of the procedures
performed with our products. The success of any new product offering or enhancement to an existing
product will depend on several factors, including our ability to:
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properly identify and anticipate surgeon and patient needs; |
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develop new products or enhancements in a timely manner; |
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develop products based on technology that we acquire, such as the technology recently
acquired from Pearsalls Limited and RSB Spine LLC; |
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avoid infringing upon the intellectual property rights of third parties; |
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demonstrate, if required, the safety and efficacy of new products with data from
preclinical studies and clinical trials; |
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obtain the necessary regulatory approvals for new products or product enhancements; |
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provide adequate training to potential users of our products; |
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receive adequate reimbursement notifications; and |
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develop an effective marketing and distribution network. |
If we do not develop new products or product enhancements in time to meet market demand or if
there is insufficient demand for these products or enhancements, our results of operations will
suffer.
We may encounter difficulties in integrating acquired products, technologies or businesses, which
could adversely affect our business.
In the second half of 2005, we acquired assets from each of Pearsalls Limited, RSB Spine LLC,
and RiverBend Design LLC, and may in the future acquire technology, products or businesses related
to our current or future business. We have limited experience in acquisition activities and may
have to devote substantial time and resources in order to complete any future acquisitions.
Further, these past and potential acquisitions entail risks, uncertainties and potential
disruptions to our business. For example, we may not be able to successfully integrate an acquired
companys operations, technologies, products and services, information systems and personnel into
our business. Further, products we acquire, such as the cervical plate we acquired from RSB Spine
LLC and the ExtenSure product acquired from RiverBend Design LLC, may not provide the intended
complementary fit with our existing products. In addition, certain acquired technology, such as
that acquired from Pearsalls Limited, requires significant additional development work and efforts
to obtain regulatory clearance or approval. An acquisition may further strain our existing
financial and managerial controls, and divert managements attention away from our other business
concerns. In connection with in-process research and development activities, we would likely
experience an increase in development expenses and capital expenditures. There may also be
unanticipated costs and liabilities associated with an acquisition that could adversely affect our
operating results.
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We are dependent on single source suppliers and manufacturers for certain of our products and
components, and the loss of any of these suppliers or manufacturers, or their inability to supply
us with an adequate supply of materials could harm our business.
We rely on third-party suppliers and manufacturers to manufacture and supply our products. To
be successful, our contract manufacturers must be able to provide us with products and components
in substantial quantities, in compliance with regulatory requirements, in accordance with agreed
upon specifications, at acceptable cost and on a timely basis. Our anticipated growth could strain
the ability of suppliers to deliver an increasingly large supply of products, materials and
components. Manufacturers often experience difficulties in scaling up production, including
problems with production yields and quality control and assurance, especially with products such as
allograft which is processed human tissue. If we are unable to obtain sufficient quantities of
high quality components to meet customer demand on a timely basis, we could lose customers, our
reputation may be harmed and our business could suffer.
We currently use one or two manufacturers for each of our devices or components. Our
dependence on one or two manufacturers involves several risks, including limited control over
pricing, availability, quality and delivery schedules. If any one or more of our manufacturers
cease to provide us with sufficient quantities of our components in a timely manner or on terms
acceptable to us, or cease to manufacture components of acceptable quality, we would have to seek
alternative sources of manufacturing. We could incur delays while we locate and engage alternative
qualified suppliers and we might be unable to engage alternative suppliers on favorable terms. Any
such disruption or increased expenses could harm our commercialization efforts and adversely affect
our ability to generate revenue.
Further, Tissue Banks International, Inc. and U.S. Tissue and Cell (formerly Intermountain
Tissue Center) collectively supply us with all of our allograft implants, and will continue to be
our only sources for the foreseeable future. The processing of human tissue into allograft
implants is very 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 allograft
implants are at times in particularly short supply. We cannot be certain that our supply of
allograft implants from Tissue Banks International and U.S. Tissue and Cell will be available at
current levels or will be sufficient to meet our needs. If we are no longer able to obtain
allograft implants from these sources in amounts sufficient to meet our needs, we may not be able
to locate and engage replacement sources of allograft implants on commercially reasonable terms, if
at all. Any interruption of our business caused by the need to locate additional sources of
allograft implants could significantly harm our revenues, which could cause the market price of our
common stock to decline.
Additionally, Invibio, Inc. is our exclusive supplier of polyetheretherketone, which comprises
our PEEK partial vertebral body product called CoRoent. We have a supply agreement with Invibio,
pursuant to which we have agreed to purchase our entire supply of polyetheretherketone from
Invibio. In addition, we have an exclusive supply arrangement with Peak Industries, Inc., pursuant
to which Peak Industries is our exclusive supplier of NeuroVision systems. In the event Peak
Industries ceases to supply us, which it may do at any time, we would be forced to locate a
suitable alternative supplier. We believe the start-up time to establish a new supply of
NeuroVision would be approximately 16 to 20 weeks. We have established an inventory of NeuroVision
systems to help us bridge any downtime in the event Peak Industries ceases to supply us; however,
this inventory may be depleted before we are able to engage an alternate supplier. Any inability
to meet our customers demands for NeuroVision systems could lead to decreased sales and harm our
reputation, which could cause the market price of our common stock to decline.
Any failure in our efforts to train spine surgeons could significantly reduce the market acceptance
of our products.
There is a learning process involved for spine surgeons to become proficient in the use of our
products. It is critical to the success of our commercialization efforts to train a sufficient
number of spine surgeons and to provide them with adequate instruction in the use of our products.
This training process may take longer than expected and may therefore affect our ability to
increase sales. Convincing surgeons to dedicate the time and energy necessary for adequate
training is challenging, and we cannot assure you we will be successful in these efforts. 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
an adverse effect on our business.
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Although we believe our training methods regarding surgeons are conducted in compliance with
FDA and other applicable regulations, if the FDA determines that our training constitutes promotion
of an unapproved use, they could request that we modify our training or subject us to regulatory
enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine
and criminal penalty.
We are dependent on the services of Alexis V. Lukianov and Keith Valentine, and the loss of either
of them could harm our business.
Our continued success depends in part upon the continued service of Alexis V. Lukianov, our
Chairman and Chief Executive Officer, and Keith Valentine, our President, who are critical to the
overall management of NuVasive as well as to the development of our technology, our culture and our
strategic direction. We have entered into employment agreements with Messrs. Lukianov and
Valentine, but neither of these agreements guarantees the service of the individual for a specified
period of time. The loss of either Messr. Lukianov or Valentine could have a material adverse
effect on our business, results of operations and financial condition. We have not obtained and do
not expect to obtain any key-person life insurance policies.
If we fail to properly manage our anticipated growth, our business could suffer.
The rapid growth of our business has placed a significant strain on our managerial,
operational and financial resources and systems. To execute our anticipated growth successfully,
we must attract and retain qualified personnel and manage and train them effectively. We will be
dependent on our personnel and third parties to effectively market our products to an increasing
number of surgeons. We will also depend on our personnel to develop next generation technologies.
Further, our anticipated growth will place additional strain on our suppliers and
manufacturers, resulting in increased need for us to carefully monitor quality assurance. Any
failure by us to manage our growth effectively could have an adverse effect on our ability to
achieve our development and commercialization goals.
In January 2005, we relocated our operations to a different facility in San Diego, California.
Although this new facility allows for growth in our business and enables us to more effectively
train surgeons in the use of our products, it has significantly increased our operating expenses.
For example, our monthly lease payments approximately doubled and we also pay increased maintenance
costs for this facility. Additionally, in September 2006, we opened our recently acquired
warehouse and distribution facility in Memphis, Tennessee, which will also increase our operating
costs. If we do not generate additional business opportunities, these additional expenses could
negatively affect our results of operations.
If we fail to obtain, or experience significant delays in obtaining, FDA clearances or approvals
for our future products or product enhancements, our ability to commercially distribute and market
our products could suffer.
Our medical devices are subject to rigorous 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 a new medical device only
after the device has received clearance under Section 510(k) of the Federal Food, Drug and Cosmetic
Act, or is the subject of an approved premarket approval application, or PMA. The FDA will clear
marketing of a medical device through the 510(k) process if it is demonstrated that the new product
is substantially equivalent to other 510(k)-cleared products. The PMA process is more costly,
lengthy and uncertain than the 510(k) clearance process. A PMA application must be supported by
extensive data, including, but not limited to, technical, preclinical, clinical trial,
manufacturing and labeling data, to demonstrate to the FDAs satisfaction the safety and efficacy
of the device for its intended use.
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Our failure to comply with such regulations could lead to the imposition of injunctions,
suspensions or loss of regulatory approvals, product recalls, termination of distribution, or
product seizures. In the most egregious cases, criminal sanctions or closure of our manufacturing
facilities are possible.
To date, all of our products, unless exempt, have been cleared through the 510(k) process. We
have no experience in obtaining premarket approval. We expect that our total disc replacement
devices currently under development, including CerPass, our investigational cervical total disc
replacement device, and NeoDisc, our investigational nucleus-like cervical disc replacement device,
will have to go through the PMA process. CerPass has not yet reached the clinical trial stage. In
June 2006, we received conditional approval of an Investigational Device Exemption (IDE) from the
FDA to begin clinical trial enrollment of NeoDisc, and the first in-human U.S. use of NeoDisc took
place in September 2006. We cannot assure you whether successful clinical trials will be conducted
or completed or regulatory approval will ultimately be obtained for these devices. Moreover,
clinical trials typically have durations of several years and competing products may be introduced
while our devices are undergoing clinical trials. This could reduce the potential demand for our
products and negatively impact our business prospects. Our competitors new products and
technologies may be more effective or less expensive than our products or render our products
obsolete.
Further, pursuant to FDA regulations, we can only market our products for cleared or approved
uses. Certain of our products may be used by physicians for indications other than those cleared
or approved by the FDA, but we cannot promote the products for such off-label uses. If the FDA
determines that our promotional materials or training constitutes promotion of an unapproved use,
it could request that we modify our training or promotional materials or subject us to regulatory
enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine
and criminal penalties. It is also possible that other federal, state or foreign enforcement
authorities might take action if they consider promotional or training materials to constitute
promotion of an unapproved use, which could result in significant fines or penalties under other
statutory authorities.
Foreign governmental authorities that regulate the manufacture and sale of medical devices
have become increasingly stringent and, to the extent we market and sell our products in foreign
countries, we may be subject to rigorous regulation in the future. In such circumstances, we would
rely significantly on our foreign independent sales agencies to comply with the varying
regulations, and any failures on their part could result in restrictions on the sale of our
products in foreign countries.
If clinical trials of our current or future product candidates do not produce results necessary to
support regulatory approval in the United States or elsewhere, we will be unable to commercialize
these products.
Several investigational devices in our development pipeline, including our NeoDisc cervical
disc replacement device, CerPass cervical total disc replacement (TDR) and lateral lumbar TDR, will
require premarket approval, or PMA, from the FDA. A PMA application must be submitted if the
device cannot be cleared through the less rigorous 510(k) process. A PMA application must be
supported by extensive data including, but not limited to, technical, preclinical, clinical trials,
manufacturing and labeling to demonstrate to the FDAs satisfaction the safety and effectiveness of
the device for its intended use.
As a result, to receive regulatory approval for NeoDisc, CerPass or other devices requiring
PMA approval, we must conduct, at our own expense, adequate and well controlled clinical trials to
demonstrate efficacy and safety in humans. Clinical testing is expensive, takes many years and has
an uncertain outcome. Clinical failure can occur at any stage of the testing. Our clinical trials
may produce negative or inconclusive results, and we may decide, or regulators may require us, to
conduct additional clinical and/or non-clinical testing. Our failure to adequately demonstrate the
efficacy and safety of any of our devices would prevent receipt of regulatory approval and,
ultimately, the commercialization of that device.
We depend on clinical investigators and clinical sites to enroll patients in our clinical trials
and other third parties to manage the trials and to perform related data collection and analysis,
and, as a result, we may face costs and delays that are outside of our control.
As a company, we have limited experience in conducting clinical trials, demonstrated by the
fact that all of our commercialized products to date have been cleared via 510(k). We recently
received conditional approval of an
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Investigational Device Exemption (IDE) from the FDA to begin clinical trial enrollment of our
NeoDisc cervical disc replacement device. In connection with this and other planned studies, we
will rely on clinical investigators and clinical sites to enroll patients in our clinical trials
and other third parties to manage the trial and to perform related data collection and analysis.
However, we may not be able to control the amount and timing of resources that clinical sites may
devote to our clinical trials. If these clinical investigators and clinical sites fail to enroll a
sufficient number of patients in our clinical trials or fail to ensure compliance by patients with
clinical protocols or fail to comply with regulatory requirements, we will be unable to complete
these trials, which could prevent us from obtaining regulatory approvals for our products. Our
agreements with clinical investigators and clinical sites for clinical testing place substantial
responsibilities on these parties and, if these parties fail to perform as expected, our trials
could be delayed or terminated. If these clinical investigators, clinical sites or other third
parties do not carry out their contractual duties or obligations or fail to meet expected
deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to
their failure to adhere to our clinical protocols, regulatory requirements or for other reasons,
our clinical trials may be extended, delayed or terminated, or the clinical data may be rejected by
the FDA, and we may be unable to obtain regulatory approval for, or successfully commercialize, our
devices.
Delays in the commencement or completion of clinical testing could significantly affect our
product development costs. Delays in the clinical trial process may require us to engage
additional clinical sites and extend our agreements with the third parties who monitor the clinical
trials and collect and analyze data. Additionally, delays in the completion of, or the potential
termination of, our clinical trials, will cause the commercial prospects for our investigational
devices to be harmed, and our ability to generate product revenues will be delayed. In addition,
many of the factors that cause, or lead to, a delay in the commencement or completion of clinical
trials may also ultimately lead to the denial of regulatory approval of a device.
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.
To date, we have obtained clearance to offer almost all of our products that require FDA
clearance or approval through the FDAs 510(k) clearance process. The FDAs 510(k) clearance
process is less rigorous than the PMA process and requires less supporting clinical data. As a
result, we currently lack the breadth of published long-term clinical data supporting the safety of
our products and the benefits they offer that might have been generated in connection with the PMA
process. For these reasons, spine surgeons may be slow to adopt our products, we may not have
comparative data that our competitors have or are generating and we may be subject to greater
regulatory and product liability risks. Further, future patient studies or clinical experience may
indicate that treatment with our products does not improve patient outcomes. Such results would
reduce demand for our products, significantly reduce our ability to achieve expected revenues and
could prevent us from becoming profitable. Moreover, if future results and experience indicate
that our products cause unexpected or serious complications or other unforeseen negative effects,
we could be subject to significant legal liability and harm to our business reputation. The spine
medical device market has been particularly prone to costly product liability litigation.
If we or our suppliers fail to comply with the FDAs quality system regulations, the manufacture of
our products could be delayed.
We and our suppliers are required to comply with the FDAs quality system regulations, which
cover the methods and documentation of the design, testing, production, control, quality assurance,
labeling, packaging, storage and shipping of our products. The FDA enforces the quality system
regulation through inspections. If we or one of our suppliers fail a quality system regulations
inspection or if any corrective action plan is not sufficient, the manufacture of our products
could be delayed. We underwent an FDA inspection in August 2003 regarding our allograft implant
business, and another FDA inspection in April 2004 regarding our medical device activities. In
connection with these inspections, the FDA requested minor corrective actions, which we believe we
have taken, but there can be no assurance the FDA will not subject us to further enforcement
action. The FDA may impose additional inspections or audits at any time.
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Modifications to our marketed products may require new 510(k) clearances or premarket approvals, or
may require us to cease marketing or recall the modified products until clearances are obtained.
Any modification to a 510(k)-cleared device that could significantly affect its safety or
efficacy, or that would constitute a major change in its intended use, requires a new 510(k)
clearance or, possibly, premarket approval. The FDA requires every manufacturer to make this
determination in the first instance, but the FDA may review any manufacturers decision. The FDA
may not agree with any of our decisions regarding whether new clearances or approvals are
necessary. If the FDA requires us to seek 510(k) clearance or premarket approval for any
modification to a previously cleared product, we may be required to cease marketing or to recall
the modified product until we obtain clearance or approval, and we may be subject to significant
regulatory fines or penalties. 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 that we seek additional approvals or clearances could result in delays, fines, costs
associated with modification of a product, loss of revenue and potential operating restrictions
imposed by the FDA.
Risks Related to Our Financial Results and Need for Financing
We have a limited operating history, have incurred significant operating losses since inception and
expect to continue to incur losses, and we cannot assure you that we will achieve profitability.
We were incorporated in Delaware in 1997, and have since focused primarily on research and
development and on seeking regulatory clearances to market our products. We began commercial sales
in 2001 and have several product offerings in both MAS and classic fusion. We have yet to
demonstrate that we can generate sufficient sales of our products to become profitable. The extent
of our future operating losses and the timing of profitability are highly uncertain, and we may
never achieve profitability. At June 30, 2006, we had an accumulated deficit of approximately
$135.4 million. It is possible that we will never generate sufficient revenues from product sales
to achieve profitability. Even if we do achieve significant revenues from our product sales, we
expect that increased operating expenses will result in significant operating losses in the near
term as we, among other things:
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pay the acquisition costs (i.e., purchase price and related expenses) and continued
development costs related to our recent acquisition of assets and technology from each of
RSB Spine LLC and Pearsalls Limited, especially with respect to the significant ongoing
development expenses associated with the assets acquired from Pearsalls Limited; |
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grow our internal and third-party sales and marketing forces to expand the penetration
of our products in the United States, and expend significant sums in connection with our
efforts to convince independents agents and sales representatives to exclusively sell our
products; |
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increase our research and development efforts to improve upon our existing products and
develop new product candidates, such as the potential products resulting from the assets
acquired from Pearsalls Limited; and |
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perform clinical research and trials on our existing products and product candidates. |
As a result of these activities, we may never become profitable. Even if we do achieve
profitability, we may not be able to sustain or increase profitability on an ongoing basis. In
addition, our independent distributors are entitled to certain payments in the event their services
are terminated in connection with (or shortly following) a change of control of our company. These
payments are the responsibility of our successor, but may represent an additional significant
expense or reduce the price paid in connection with any such event.
Our quarterly financial results are likely to fluctuate significantly because our sales prospects
are uncertain.
Our quarterly operating results are difficult to predict and may fluctuate significantly from
period to period, particularly because our sales prospects are uncertain. These fluctuations will
also affect our annual operating
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results and may cause those results to fluctuate unexpectedly from year to year. 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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our ability to drive increased sales of our products to hospitals and surgeons; |
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our ability to establish and maintain an effective and dedicated sales force; |
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pricing pressure applicable to our products, including adverse third-party reimbursement outcomes; |
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results of clinical research and trials on our existing products and products in
development and our ability to obtain FDA approval or clearance; |
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the mix of our products sold (i.e., profit margins differ between our products); |
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timing of new product offerings, acquisitions, licenses or other significant events by
us or our competitors; |
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the ability of our suppliers to timely provide us with an adequate supply of materials
and components; |
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the evolving product offerings of our competitors and the potential introduction of new
and competing technologies; |
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regulatory approvals and legislative changes affecting the products we may offer or
those of our competitors; and |
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interruption in the manufacturing or distribution of our products. |
Many of the products we may seek to develop and introduce in the future will require FDA
approval or clearance, without which we cannot begin to commercialize them in the United States,
and commercialization of them outside of the United States would likely require other regulatory
approvals and import licenses. As a result, it will be difficult for us to forecast demand for
these products with any degree of certainty. In addition, we will be increasing our operating
expenses as we build our commercial capabilities. Accordingly, we may experience significant,
unanticipated quarterly losses. Because of these factors, our operating results in one or more
future quarters may fail to meet the expectations of securities analysts or investors.
Risks Related to Our Intellectual Property and Potential Litigation
Our ability to protect our intellectual property and proprietary technology through patents and
other means is uncertain.
Our success depends significantly on our ability to protect our proprietary rights to 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, our pending U.S. and foreign patent applications may not issue
as patents in a form that will be advantageous to us or may issue and be subsequently successfully
challenged by others and invalidated. In addition, our pending patent applications include claims
to material 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 which provide outcomes which are comparable to ours. Although we have taken steps to
protect our intellectual property and proprietary technology, including entering into
confidentiality agreements and intellectual property assignment agreements with our officers,
employees, consultants and advisors, 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. Furthermore, the laws of some
foreign countries may not protect our intellectual property rights to the same extent as do the
laws of the United States.
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In the event a competitor infringes upon our patent or other intellectual property rights,
enforcing those rights may be costly, difficult and time consuming. Even if successful, litigation
to enforce our intellectual property rights or to defend our patents against challenge could be
expensive and time consuming and could divert our managements attention. We may not have
sufficient resources to enforce our intellectual property rights or to defend our patents against a
challenge.
In addition, certain product categories, including pedicle screws, have been the subject of
significant litigation in recent years. Since we sell pedicle screws and recently introduced our
SpheRx pedicle screw system, any related litigation could harm our business.
The medical device industry is characterized by the existence of a large number of patents and
frequent litigation based on allegations of patent infringement. Patent litigation can involve
complex factual and legal questions and its outcome is uncertain. Any claim relating to
infringement of patents that is successfully asserted against us may require us to pay substantial
damages. Even if we were to prevail, any litigation could be costly and time-consuming and would
divert the attention of our management and key personnel from our business operations. Our success
will also depend in part on our not infringing patents issued to others, including our competitors
and potential competitors. If our products are found to infringe the patents of others, our
development, manufacture and sale of such potential products could be severely restricted or
prohibited. In addition, our competitors may independently develop similar technologies. Because
of the importance of our patent portfolio to our business, we may lose market share to our
competitors if we fail to protect our intellectual property rights.
As the number of entrants into our market increases, the possibility of a patent infringement
claim against us grows. While we make an effort to ensure that our products do not infringe other
parties patents and proprietary rights, our products and methods may be covered by patents held by
our competitors. In addition, our competitors may assert that future products we may market
infringe their patents.
A patent infringement suit brought against us or any strategic partners or licensees may force
us or any strategic partners or licensees to stop or delay developing, manufacturing or selling
potential products that are claimed to infringe a third partys intellectual property, unless that
party grants us or any strategic partners or licensees rights to use its intellectual property. In
such cases, we may be required to obtain licenses to patents or proprietary rights of others in
order to continue to commercialize our products. However, we may not be able to obtain any
licenses required under any patents or proprietary rights of third parties on acceptable terms, or
at all. Even if any strategic partners, licensees or we were able to obtain rights to the third
partys intellectual property, these rights may be non-exclusive, thereby giving our competitors
access to the same intellectual property. Ultimately, we may be unable to commercialize some of
our potential products or may have to cease some of our business operations as a result of patent
infringement claims, which could severely harm our business.
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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, 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. In addition, we sell allograft implants, derived from cadaver bones, which pose the
potential risk of biological contamination. If any such contamination is found to exist, sales of
allograft products could decline.
Currently, we maintain product liability insurance in the amount of $10 million. Any product
liability claim brought against us, with or without merit, could result in the increase of our
product liability insurance rates or the inability to secure coverage in the future. 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, if such reserves are not sufficient, which may harm our
financial condition. If longer-term patient results and experience indicate that our products or
any component cause tissue damage, motor impairment or other adverse effects, we could be subject
to significant liability. Finally, even a meritless or unsuccessful product liability claim could
harm our reputation in the industry, lead to significant legal fees and could result in the
diversion of managements attention from managing our business.
Any claims relating to our making improper payments to physicians for consulting services, or other
potential violations of regulations governing interactions between us and healthcare providers,
could be time consuming and costly.
We frequently engage spine surgeons as consultants to assist us with scientific research and
development and to help us evaluate technologies. We are subject to federal and state laws and
regulations governing our relationships with physicians and other health care providers. In April
2005, the United States Department of Justice expanded its investigation into the relationships
between medical device companies and health care providers. The investigation originally appeared
to focus on Medtronic Sofamor Danek, Inc., but the Department of Justice has apparently since
issued subpoenas to DePuy Spine, Inc., a Johnson & Johnson company, Biomet, Smith & Nephew, Stryker
and Zimmer Holdings, all orthopedic device manufacturers, relating to the consulting process and
procedures tied to fees that such companies have paid to physicians as consultants. Although we
have not been contacted by the Department of Justice in respect of this investigation, we could
become a subject of the investigation and be forced to incur significant costs as a result.
The regulations governing the interactions between medical device companies and health care
providers continue to evolve. Compliance with these regulations is costly, especially as accepted
methods of compliance are developed. We expect to continue to incur costs related to compliance
with these new measures.
We or our suppliers may be the subject of claims for non-compliance with FDA regulations in
connection with the processing or distribution of allograft implants.
It is possible that allegations may be made against us or against donor recovery groups or
tissue banks, including those with which we have a contractual relationship, claiming that the
acquisition or processing of tissue for allograft implants does not comply with applicable FDA
regulations or other relevant statutes and regulations. Allegations like these could cause
regulators or other authorities to take investigative or other action against us, or could cause
negative publicity for us or our industry generally. These actions or any negative publicity could
cause us to incur substantial costs, divert the attention of our management from our business, harm
our reputation and cause the market price of our shares to decline.
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Risks Related to the Securities Markets and Ownership of Our Common Stock
We expect that the price of our common stock will fluctuate substantially, potentially adversely
affecting the ability of investors to sell their shares.
The market price of our common stock is likely to be highly volatile and may fluctuate
substantially due to many factors, including:
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volume and timing of orders for our products; |
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the introduction of new products or product enhancements by us or our competitors; |
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disputes or other developments with respect to intellectual property rights or other
potential legal actions; |
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our ability to develop, obtain regulatory clearance or approval for, and market new and
enhanced products on a timely basis; |
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product liability claims or other litigation; |
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quarterly variations in our or our competitors results of operations; |
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sales of large blocks of our common stock, including sales by our executive officers and directors; |
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announcements of technological or medical innovations for the treatment of spine pathology; |
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changes in governmental regulations or in the status of our regulatory approvals,
clearances or applications; |
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changes in the availability of third-party reimbursement in the United States or other countries; |
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the acquisition or divestiture of products, assets or technology; |
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changes in earnings estimates or recommendations by securities analysts; and |
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general market conditions and other factors, including factors unrelated to our
operating performance or the operating performance of our competitors. |
Market price fluctuations may negatively affect the ability of investors to sell our shares at
consistent prices.
Recent
changes in the required accounting treatment for stock options have
had a material negative
impact on our financial statements and may affect our stock price.
In December 2004, the Financial Accounting Standards Board, or FASB, issued SFAS No. 123R,
which focuses primarily on accounting for transactions in which an
entity obtains employee services through share-based payment
transactions. SFAS 123R requires us to measure the cost of
employee services received in exchange for the award of equity
instruments based on the fair value of the award at the date of
grant. The cost will be recognized over the period during which an
employee is required to provide services in exchange for the award.
We adopted SFAS 123R in the first quarter of 2006, as required.
As a result, our reported earnings have been reduced, which may affect our stock price.
We may become involved in securities class action litigation that could divert managements
attention and harm our business.
The stock market in general, the NASDAQ Global 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
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companies have been particularly volatile. These broad market and industry factors may
materially harm the market price of our common stock, regardless of our operating performance. In
the past, following periods of volatility in the market price of a particular companys 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 often is expensive and diverts
managements attention and resources, which could materially harm our financial condition and
results of operations.
Anti-takeover provisions in our organizational documents and Delaware law 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 and prevent attempts by our stockholders to replace or remove our
current management.
Our certificate of incorporation and bylaws contain provisions that could delay or prevent a
change of control of our company or changes in our board of directors that our stockholders might
consider favorable. Some of these provisions:
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authorize the issuance of preferred stock which can be created and issued by the board
of directors without prior stockholder approval, with rights senior to those of the common
stock; |
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provide for a classified board of directors, with each director serving a staggered
three-year term; |
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prohibit our stockholders from filling board vacancies, calling special stockholder
meetings, or taking action by written consent; |
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prohibiting our stockholders from making certain changes to our certificate of
incorporation or bylaws except with 66 2¤3% stockholder
approval; and |
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require advance written notice of stockholder proposals and director nominations. |
In addition, we are subject to the provisions of Section 203 of the Delaware General
Corporation Law, which may prohibit certain business combinations with stockholders owning 15% or
more of our outstanding voting stock. These and other provisions in our certificate of
incorporation, our bylaws and Delaware law could make it more difficult for stockholders or
potential acquirers to obtain control of our board of directors or initiate actions that are
opposed by our then-current board of directors, including delay or impede a merger, tender offer,
or proxy contest involving our company. Any delay or prevention of a change of control transaction
or changes in our board of directors could cause the market price of our common stock to decline.
We do not intend to pay cash dividends.
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,
the terms of any future debt or credit facility may preclude us from paying any dividends. As a
result, capital appreciation, if any, of our common stock will be our stockholders source of
potential gain for the foreseeable future.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains include forward-looking statements within the meaning of Section 27A
of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. All
statements, other than statements of historical fact, are statements that could be deemed
forward-looking statements, including, but not limited to, statements regarding our future
financial position, business strategy and plans and objectives of management for future operations.
When used in this prospectus, the words believe, may, could will, estimate, continue,
anticipate, intend, expect and similar expressions are intended to identify forward-looking
statements.
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We have based these forward-looking statements largely on our current expectations and
projections about future events and financial trends that we believe may affect our financial
condition, results of operations, business strategy, short-term and long-term business operations
and objectives, and financial needs. These forward-looking statements are subject to certain risks
and uncertainties that could cause our actual results to differ materially from those reflected in
the forward-looking statements. Factors that could cause or contribute to such differences
include, but are not limited to, those discussed in this prospectus, and in particular, the risks
discussed under the heading Risk Factors and those discussed in other documents we file with the
Securities and Exchange Commission. Except as required by law, we do not intend to update these
forward-looking statements publicly or to update the reasons actual results could differ materially
from those anticipated in these forward-looking statements, even if new information becomes
available in the future.
In light of these risks, uncertainties and assumptions, the forward-looking events and
circumstances discussed in this prospectus and in the documents incorporated in this prospectus may
not occur and actual results could differ materially and adversely from those anticipated or
implied in the forward-looking statements. Accordingly, readers are cautioned not to place undue
reliance on such forward-looking statements.
USE OF PROCEEDS
All shares of our common stock offered by this prospectus are being registered for the account
of the selling stockholder. We will not receive any of the proceeds from the sale of these shares.
SELLING STOCKHOLDER
All of the shares of common stock registered for sale pursuant to this prospectus are
currently owned by the selling stockholder. All of the shares offered hereby were acquired by the
selling stockholder in September 2006 in connection with our buyout of all of our current and
future milestone and royalty obligations related to our acquisition of assets and technology from
Pearsalls Limited in August 2005. The shares were issued pursuant to Amendment No. 1 to Asset
Purchase Agreement, dated as of September 26, 2006, by and among us, Pearsalls Limited and American
Medical Instruments Holdings, Inc. The selling stockholder does not have a material relationship
with us.
The following table sets forth the name of the selling stockholder, the number of shares of
common stock owned by the selling stockholder immediately prior to the date of this prospectus, the
number of shares that may be acquired by the selling stockholder following the date of this
prospectus, and the total number of shares that may be offered pursuant to this prospectus. The
table also provides information regarding the beneficial ownership of our common stock by the
selling stockholder as adjusted to reflect the assumed sale of all of the shares offered under this
prospectus. Percentage of beneficial ownership before this offering is based on 33,880,852 shares
of our common stock outstanding as of September 30, 2006. The selling stockholder may offer the
shares for sale from time to time in whole or in part. Except where otherwise noted, the selling
stockholder named in the following table has, to our knowledge, sole voting and investment power
with respect to the shares beneficially owned by it.
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Beneficial |
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Ownership Before Offering |
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Beneficial Ownership After Offering |
Selling Stockholder |
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Shares Owned |
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Percent |
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Registered |
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Percent |
Pearsalls Limited |
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401,956 |
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1.2 |
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401,956 |
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The selling stockholder provided us with information with respect to its share ownership.
Because the selling stockholder may sell all, part or none of its shares, we are unable to estimate
the number of shares that will be held by the selling stockholder upon resale of shares of common
stock being registered hereby. We have, therefore, assumed for the purposes of the registration
statement related to this prospectus that the selling stockholder will sell all of its shares. See
Plan of Distribution.
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PLAN OF DISTRIBUTION
The selling stockholder and any of its pledgees, assignees and successors-in-interest may,
from time to time, sell any or all of the shares of common stock on any stock exchange, market or
trading facility on which the shares are traded or in private transactions. These sales may be at
fixed or negotiated prices. The selling stockholder may use any one or more of the following
methods when selling shares:
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ordinary brokerage transactions and transactions in which the broker-dealer solicits
purchasers; |
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block trades in which the broker-dealer will attempt to sell the shares as agent but may
position and resell a portion of the block as principal to facilitate the transaction; |
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purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
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an exchange distribution in accordance with the rules of the applicable exchange; |
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privately negotiated transactions; |
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settlement of short sales; |
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broker-dealers may agree with the selling stockholder to sell a specified number of such
shares at a stipulated price per share; |
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a combination of any such methods of sale; |
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through the writing or settlement of options or other hedging transactions, whether
through an options exchange or otherwise; or |
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any other method permitted pursuant to applicable law. |
The selling stockholder may also sell shares under Rule 144 under the Securities Act, if
available, rather than under this prospectus.
Broker-dealers engaged by the selling stockholder may arrange for other brokers-dealers to
participate in sales. Broker-dealers may receive commissions or discounts from the selling
stockholder (or, if any broker-dealer acts as agent for the purchaser of shares, from the
purchaser) in amounts to be negotiated. The selling stockholder does not expect these commissions
and discounts relating to its sales of shares to exceed what is customary in the types of
transactions involved.
In connection with the sale of our common stock or interests therein, the selling stockholder
may enter into hedging transactions with broker-dealers or other financial institutions, which may
in turn engage in short sales of the common stock in the course of hedging the positions they
assume. The selling stockholder may also sell shares of our common stock short and deliver these
securities to close out its short positions, or loan or pledge the common stock to broker-dealers
that in turn may sell these securities. The selling stockholder may also enter into option or
other transactions with broker-dealers or other financial institutions or the creation of one or
more derivative securities which require the delivery to such broker-dealer or other financial
institution of shares offered by this prospectus, which shares such broker-dealer or other
financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect
such transaction).
The selling stockholder and any broker-dealers or agents that are involved in selling the
shares may be deemed to be underwriters within the meaning of the Securities Act in connection
with such sales. In such event, any commissions received by such broker-dealers or agents and any
profit on the resale of the shares purchased by them may be deemed to be underwriting commissions
or discounts under the Securities Act. The selling stockholder has informed us that it does not
have any agreement or understanding, directly or indirectly, with any person to distribute the
common stock.
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Because the selling stockholder may be deemed to be an underwriter within the meaning of the
Securities Act, it will be subject to the prospectus delivery requirements of the Securities Act.
In addition, any securities covered by this prospectus which qualify for sale pursuant to Rule 144
under the Securities Act may be sold under Rule 144 rather than under this prospectus. The selling
stockholder has advised us that it has not entered into any agreements, understandings or
arrangements with any underwriter or broker-dealer regarding the sale of the resale shares. There
is no underwriter or coordinating broker acting in connection with the proposed sale of the resale
shares by the selling stockholder.
The shares will be sold only through registered or licensed brokers or dealers if required
under applicable state securities laws. In addition, in certain states, the shares may not be sold
unless they have been registered or qualified for sale in the applicable state or an exemption from
the registration or qualification requirement is available and is complied with.
Under applicable rules and regulations under the Securities Exchange Act of 1934, as amended
(the Exchange Act), any person engaged in the distribution of the resale shares may not
simultaneously engage in market making activities with respect to our common stock for a period of
two business days prior to the commencement of the distribution. In addition, the selling
stockholder will be subject to applicable provisions of the Exchange Act and the rules and
regulations thereunder, including Regulation M, which may limit the timing of purchases and sales
of shares of our common stock by the selling stockholder or any other person. We will make copies
of this prospectus available to the selling stockholder and have informed the selling stockholder
of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the
sale.
We will not receive any proceeds from the sale of the shares by the selling stockholder.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated
financial statements and schedule included in our Annual Report on Form 10-K for the year ended
December 31, 2005 and managements assessment of the effectiveness of internal control over
financial reporting as of December 31, 2005, as set forth in their reports, which are incorporated
by reference in this prospectus and elsewhere in the registration statement. Our financial
statements and schedule and managements assessment are incorporated by reference in reliance on
Ernst & Young LLPs reports, given on their authority as experts in accounting and auditing.
LEGAL MATTERS
The validity of the issuance of the shares of common stock offered hereby and certain other
legal matters in connection therewith have been passed upon for us by Heller Ehrman LLP, San Diego,
California.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the information reporting requirements of the Exchange Act and we file
periodic reports, proxy statements and other information with the Securities and Exchange
Commission relating to our business, financial results and other matters. The reports, proxy
statements and other information we file may be inspected and copied at prescribed rates at the
Securities and Exchange Commissions Public Reference Room and via the Securities and Exchange
Commissions website (see below for more information).
In connection with the common stock offered by this prospectus, we have filed a registration
statement on Form S-3 under the Securities Act with the Securities and Exchange Commission. This
prospectus, filed as part of that registration statement, does not contain all of the information
included in that registration statement and its accompanying exhibits and schedules. For further
information with respect to our common stock and us you should refer to that registration statement
and its accompanying exhibits and schedules.
You may inspect a copy of the registration statement of which this prospectus is a part and
its accompanying exhibits and schedules, as well as the reports, proxy statements and other
information we file with the Securities and Exchange Commission, without charge at the Securities
and Exchange Commissions Public Reference Room, 100 F Street, N.E., Room 1580, Washington, D.C.
20549, and you may obtain copies of all or any part of the registration statement from those
offices for a fee. You may obtain information on the operation of the Public Reference Room
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by calling the Securities and Exchange Commission at 1-800-SEC-0330. The Securities and
Exchange Commission maintains a web site that contains registration statements, reports, proxy and
information statements and other information regarding registrants that file electronically,
including us. The address of the site is http://www.sec.gov.
DOCUMENTS INCORPORATED BY REFERENCE
The Securities and Exchange Commission allows us to incorporate by reference information in
this prospectus and other information that we file with the Securities and Exchange Commission,
which means that we can disclose important information to you by referring to those documents. The
information incorporated by reference is an important part of this prospectus. The following
documents filed by us with the Securities and Exchange Commission are incorporated herein by
reference:
(1) Annual Report on Form 10-K for the fiscal year ended December 31, 2005, as filed on March
15, 2006;
(2) Quarterly Report on Form 10-Q for the quarter ended March 31, 2006, as filed May 10, 2006;
(3) Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, as filed August 8,
2006;
(4) Current Reports on Form 8-K, as filed on January 9, 2006, February 7, 2006 (but only as to
Item 1.01), March 13, 2006, May 30, 2006 and September 29, 2006; and
(5) the description of our common stock contained in our registration statement on Form S-1,
filed March 5, 2004, under the caption Description of Capital StockCommon Stock, together with
Amendments Nos. 1, 2, 3 and 4 on Form S-1/A filed with the Securities and Exchange Commission on
April 8, 2004, April 26, 2004, May 5, 2004 and May 11, 2004, respectively, and in any report filed
for the purpose of amending such description.
All documents subsequently filed by us with the Securities and Exchange Commission pursuant to
Section 13(a), 13(c), 14 or 15(d) of the Exchange Act and prior to the termination of this
offering, shall be deemed to be incorporated by reference in this prospectus. Any statement
contained in a document incorporated or deemed to be incorporated by reference herein shall be
deemed to be modified or superseded for purposes of this prospectus to the extent that a statement
contained herein, or in any other subsequently filed document that also is or is deemed to be
incorporated by reference herein, modifies or supersedes such statement. Any such statement so
modified or superseded shall not be deemed, except as so modified or superseded, to constitute a
part of this prospectus.
We will provide, without charge, to each person, including any beneficial owner, to whom a
copy of this prospectus is delivered, upon the written or oral request of such person, a copy of
any or all of the documents that have been incorporated herein by reference, but are not delivered
with this prospectus, other than exhibits to such documents (unless such exhibits are specifically
incorporated by reference therein). Requests for such copies should be directed to:
NuVasive, Inc.
4545 Towne Centre Court
San Diego, California 92121
Attn: Chief Financial Officer
You should rely only on the information contained in this prospectus. We have not authorized
any person to provide you with information different from that contained in this prospectus. This
prospectus may be used only where it is legal to sell the common stock of NuVasive, Inc. The
information contained in this prospectus is accurate only as of the date of this prospectus,
regardless of the date of delivery of this prospectus or of any sale of the common stock of
NuVasive, Inc.
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