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FORM 10-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended December 31, 1998 Commission file number 0-28492
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INNOVASIVE DEVICES, INC.
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(Exact name of registrant as specified in its charter)
Massachusetts 04-3132641
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(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
734 Forest Street, Marlborough MA 01752
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(Address of principal executive offices)
Registrant's telephone number, including area code 508/460-8229
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N/A
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Former name, former address and former fiscal year, if changed since last
report.
Securities registered pursuant to Section 12(b) of the Act: NONE
Securities registered pursuant to Section 12(g) of the Act: COMMON STOCK $.0001
PAR VALUE
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 X No .
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Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained, to the
best of registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to
this Form 10-K. [ ]
The aggregate market value of the voting stock held by non-affiliates of the
Registrant, based upon the closing price of the Common Stock on March 24, 1998,
on the NASDAQ Stock Market, was approximately $ 20,520,565. Shares of Common
Stock held by each officer and director and by each person who owns 5% or more
of the outstanding Common Stock have been excluded in that such persons may be
deemed to be affiliates. This determination of affiliate status is not
necessarily a conclusive determination for other purposes.
As of March 24, 1999 the Registrant had 9,207,249 shares of Common Stock
outstanding.
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Part I
Item 1. Business
General
The Company designs, develops, manufactures and markets proprietary tissue
repair systems which facilitate the repair of soft tissue injuries. The
Company's tissue repair systems are designed to be used in either open surgical
or minimally invasive arthroscopic procedures. Performing repairs
arthroscopically offers several benefits, including reduced patient trauma and
shorter rehabilitation times, resulting in a faster return to full physical
activity. The Company currently markets a broad-based product line within five
product platforms: suture fasteners, suturing systems, cartilage repair,
anterior cruciate ligament ("ACL") reconstruction and meniscal repair products.
These product platforms have been developed to drive the emerging growth trends
in the sports medicine segment of the orthopaedics market: the movement away
from metallic implants in and around the joints and the development of
definitive soft tissue repairs to replace existing palliative treatments.
The Company competes in the soft tissue repair segment of the sports
medicine/arthroscopic surgery market. The Company markets its products and
related instruments principally to sports medicine orthopaedic surgeons who
treat and repair soft tissues, within and around joints, which have been damaged
by traumatic injury or degenerative disease.
The Company is focusing its efforts on this market primarily because of two
factors: the projected growth of the segment and the potential for improvement
over conventional clinical methods and products.
The Company's products are based on unique and proprietary technologies. Based
on its existing designs, the Company is developing and currently testing next
generation products using bioabsorbable composites, which degrade and absorb
into surrounding tissue, and collagen-based biomaterial composites, which
remodel into surrounding tissue. In addition, the Company is pursuing
opportunities to apply its core technologies outside of orthopaedics.
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Principal Products and Applications
The Company currently markets proprietary devices and instruments encompassing
five product platforms: Suture Fasteners, Suture Systems, Cartilage Repair
Systems, Anterior Cruciate Ligament ("ACL") Repair Systems and Meniscal Repair
Systems. All of the Company's current products have received 510(K) clearance
or have been exempted by the FDA from the 510(K) clearance process. The
following chart sets forth the product release date, current applications and
features and benefits of the Company's principal products:
<TABLE>
<CAPTION>
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Initial Current
Product Release Date Applications Features and Benefits
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Suture Fasteners
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<S> <C> <C> <C>
ROC EZ(TM) Suture Fastener Implants June 1997 Shoulder, knee, foot, ankle, . primary fastener for hard bone
bladder neck suspension . all polymer design
. revisable
. available for open and
arthroscopic repair
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ROC XS(TM) Suture Fastener Implants May 1996 Shoulder, bladder neck . primary fastener for soft bone
suspension . all polymer design
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MiniROC(TM) Suture Fastener Implants April 1996 Shoulder, hand and wrist . primary fastener for small bones
. all polymer design
. revisable
. 5mm fastener length
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Bioabsorbable BioROC EZ(TM) April 1998 Shoulder, elbow, knee, . L-PLA bioabsorbable polymer
Fastener Implants foot, ankle . revisable
. available for open and
arthroscopic repair
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Suture Systems
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Cuff Link(TM) Bone Tunnel July 1997 Rotator Cuff . prevents suture migration though
Augmentation Device bone following rotator
cuff repair
. protects the suture/bone
interface when using
transosseous tunnels
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Ideal (TM) Suture Grasper January 1995 Open and arthroscopic . 15, 30, 45 and 60 degree angles
knot tying . athroscopically sutures tissue
without needles
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Y-Knot (TM) Arthroscopic Knot April 1998 Open and arthroscopic . reproducible security of
Replacement knot tying traditional knots eliminates
complexity of tying arthroscopic
knots
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Cuff Guard(TM) Expanded Body Suture April 1998 Rotator Cuff . expanded body suture matches
holding strength of multiple
stitch techniques
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Cartilage Repair Systems
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COR(TM) System September 1996 Grafting of bone plugs . cutter allows for precise
in the knee cutting of bone plugs
. bone plugs are cleanly
transferred to donor site
. 4, 6 and 8mm cutter diameters
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</TABLE>
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Principal Products and Applications (continued)
<TABLE>
<CAPTION>
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Initial Current
Product Release Date Applications Features and Benefits
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ACL Repair Systems
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<S> <C> <C> <C>
Linx HT November 1997 ACL soft tissue graft femoral . links hamstring directly to bone
fixation . provides permanent biocompatible
fixation
. strong fixation using
conventional technique
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Cannulated Interference Screw System August 1997 ACL bone-tendon-bone fixation . design minimized tissue trauma
. locking thread secures bone
block fixation
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GeoFit(TM) Screw and Washer System October 1997 ACL soft tissue graft femoral . low profile screws and washers
and tibial fixation minimize tissue irritation
. washers shaped to conform to
bone contours
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Transverse Fixation System January 1998 ACL bone-tendon-bone and . rigid graft fixation
soft tissue graft femoral . simplifies femoral graft
fixation insertion and passage
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General ACL Instruments March 1998 ACL bone-tendon-bone and . complete systematic approach
soft tissue graft femoral and to endoscopic ACL
tibial fixation reconstruction
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Meniscal Repair Systems
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Clearfix(TM) Meniscal Screw October 1998 Repair posterior longitudinal . headless, to preclude abrasion
meniscus tears . may be repositioned for optimal
purchase
. molded PLA resists splintering
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</TABLE>
The Company also markets instrumentation used in the surgical implementation of
the products listed above.
The Company's line of suture fasteners was expanded in March 1998 with the
release of the BioROC, a bioabsorbable suture fastener which degrades and
absorbs into the surrounding bone and tissue after the repaired tissue has
sufficiently healed back to the bone.
Two new product lines were introduced within the suturing systems product line
in 1998: the Y-Knot, a device used in place of traditional knot configurations
when securing soft tissue to bone and the Cuff Guard, a suture with an expanded
surface area.
The Company introduced two new ACL reconstruction product lines in 1998: the
Transverse Fixation System, an ACL repair system which provides femoral fixation
of hamstring tendon grafts and a general ACL Repair system used in both patellar
tendon and hamstring tendon ACL reconstruction procedures.
In October 1998, the Company announced the commercial release of its Clearfix
Meniscal Screw, a bioabsorbable device used to repair traumatic tears within the
meniscus of the knee through a minimally invasive arthroscopic approach.
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Product Development
The Company has new products in various stages of development designed to
address a variety of clinical needs. The Company has been primarily developing
products in five market platforms: Suture Fasteners, Suture Systems, Anterior
Cruciate Ligament Repair Systems, Cartilage Repair Systems and Meniscal Repair
Systems. The Company utilizes a wide variety of materials to address the
mechanical requirement of the surgical repair in its product development
process. These materials include polymer, absorbable, biologic and metallic
formulations. The Company seeks regulatory clearance to market its products
throughout the world.
The Company's objective is to continue to develop innovative products for the
sports medicine/arthroscopy market and to leverage its core proprietary
technology in other markets. The Company's research and development team
currently consists of eight engineers with substantial design experience in the
field of orthopaedics and arthroscopy. During the fiscal year ended December
31, 1998, 1997 and 1996 the Company incurred expenses of $4.3 million, $4.0
million and $2.7 million, respectively, in connection with its research and
development efforts.
The Company's research and development team is continually engaged in assessing
new tissue repair device technologies and techniques which are applicable to the
Company's business strategy. The research and development engineers spend a
significant amount of time with surgeon advisors and members of the Company's
Medical Advisory Board in evaluating new product ideas. The Company has
collaborative arrangements with university-based research centers for pre-
clinical design testing. In the future, the Company's research and development
efforts may include the identification of new technologies developed by others
and the acquisition or licensing of new technologies and product lines.
Sales and Marketing
The Company's sales and marketing strategy is to focus its efforts on
arthroscopic/sports medicine surgeons through a combination of direct sales
calls, clinical workshops and presentations to medical arthroscopic surgeons and
sports medicine specialists. The Company's clinical sales agents and marketing
personnel meet with surgeons to conduct product demonstrations, attend surgical
procedures and provide training. Sales and marketing personnel also attend
numerous domestic and foreign medical conventions each year where they exhibit
and demonstrate the Company's products.
The Company markets its products to surgeons in the United States through a
network of twenty-six clinical employee sales representatives, 126 independent
sales agents and five regional sales managers. In addition to its field sales
force, as of March 24, 1999 the Company employed a staff of eleven corporate
marketing, sales and customer service support staff employees. This staff
manages clinical training workshops, sales management, print and video
promotion, sales data analysis, convention management and international
marketing. The Company ships to and invoices its hospital customers directly in
the US.
The Company markets its products internationally through nineteen established
distributors of orthopaedic medical devices. The Company's products are sold
directly to stocking distributors who sell the products to hospitals and
clinics. For the year ended December 31, 1998, international sales accounted
for 17% of net sales.
The Company also works with a Medical Advisory Board (the "MAB") of six surgeons
and a Clinical Advisory Group (the "CAG") of nineteen surgeons located across
the United States. The members of the MAB and CAG are opinion leaders in the
field of arthroscopy and sports medicine and are affiliated with professional
athletic teams, collegiate athletic departments and major orthopaedic hospitals.
The Company relies on the MAB and CAG to conduct workshops at which new surgeons
train on the use of the Company's products,
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evaluate products clinically prior to their general market release, present the
Company's products at conferences, assist in creating training videos and advise
the Company on new surgical and product techniques.
Manufacturing and Quality Control
The manufacture of the Company's devices and instruments consists of inspection,
assembly, testing, packaging and sterilization of components that have been
molded, machined or manufactured by the Company or to the Company's
specifications by outside contractors. Samples of sterilized products are sent
to a certified laboratory to validate that sterilization procedures have been
adequately performed. After this validation, the products are shipped to
customers. The Company maintains a high level of quality control and inspects
each lot of components to ensure that they comply with the Company's exacting
specifications. Most purchased components are available from more than one
vendor. For certain components, there are relatively few alternative sources of
supply and establishment of additional or replacement suppliers for such
components cannot be accomplished quickly. Many components are injection molded
using Company owned molds. Many polymer components have only one mold and
replacement of the molds can take 12 to 16 weeks. Bioabsorbable materials used
in products are likely to be available from only a single source. Any supply
interruption from single source vendors could have a material adverse effect on
the Company's ability to supply products. There is risk that certain suppliers
may terminate sales of certain materials to companies that manufacture medical
devices in an attempt to limit their potential product liability exposure. If
the materials which are used to manufacture the Company's polymer and absorbable
based devices become unavailable, the Company would be required to identify a
new polymer and absorbable materials for the devices and certify the quality and
suitability of the new material. In addition, a new 510(k) clearance would have
to be obtained to market products manufactured from the new materials. This
process could take a substantial period of time and there is no assurance that
the Company would be able to identify, certify or obtain clearance for new
polymer or absorbable based fasteners. The Company operates manufacturing
facilities in Marlborough, MA and Logan UT.
The Company abides by the FDA's Good Manufacturing Practices and the
requirements of foreign regulatory agencies. The Company's Marlborough, MA
manufacturing facility received ISO 9001 registration and EN 46001 certification
in October 1997.
Relationship with Cohesion Technologies, Inc. (formerly Collagen Corporation)
In October 1995, the Company entered into Research & Development, Distribution
and Supply agreements (the "Agreements") with Collagen Corporation ("Collagen").
In October 1997, Collagen announced that it would proceed to separate its
Aesthetic Technologies Group and its Collagen Technologies Group ("CTG") into
two independent, publicly traded companies. Cohesion Technologies, Inc.
("Cohesion") was organized as a Delaware corporation and wholly owned subsidiary
of Collagen in June 1997. Effective January 1, 1998, Collagen contributed
certain research and development programs of CTG to Cohesion including its
development program with Innovasive. Collagen also contributed various equity
investments to Cohesion including all of its holdings in Innovasive Devices,
Inc. In connection with the separation, Collagen distributed as a dividend to
its stockholders on August 18,1998, one share of Cohesion common stock for each
share of Collagen common stock outstanding. As a result of this transaction,
Cohesion Technologies holds 843,936 shares, or approximately 9.2% of the common
stock of Innovasive Devices, Inc. Pursuant to an agreement among the Company
and certain of its stockholders, Cohesion Technologies has the right to
designate one member of the Company's Board of Directors so long as it holds at
least five percent of the Company's outstanding Common Stock on a fully-diluted
basis. David Foster, Chief Executive Officer of Cohesion Technologies,
currently serves as Cohesion Technologies' designee on the Company's Board of
Directors.
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Pursuant to the agreements assigned to Cohesion Technologies, the Company and
Cohesion have cross-licensed their respective technologies relating to collagen
materials and medical devices. Under the Research and Development Agreement, the
Company and Cohesion have agreed to undertake the joint development of suture
fasteners made from collagen-based materials, to be funded by the Company up to
certain amounts as specified in an agreed project plan. The Research and
Development Agreement contemplates subsequent development of collagen-based
tissue fixation devices if the parties can agree on a project plan and budget
for their development. Any technology jointly developed pursuant to a project
plan is to be owned jointly by the parties. Until October 17, 2000, the parties
have agreed to work exclusively together with respect to the development of
products covered by the agreement. With respect to products for which a project
plan has been approved by the parties prior to October 17, 2000 and for which
there is funding through completion of development, Cohesion and the Company
have agreed not to commence the development of competing products until after
the second anniversary of the first commercial sale of such products.
The Manufacturing and Supply Agreement provides that Cohesion will be the
exclusive supplier to the Company for products manufactured from collagen and
developed under the Research and Development Agreement. If Cohesion is unable
to supply such products, the Company is entitled to develop a second source of
supply. The Manufacturing and Supply Agreement remains in effect with respect
to a product until either the Distribution Agreement between Cohesion and the
Company relating to such product terminates, expires or until the Manufacturing
Agreement is terminated by reason of default or as the result of the bankruptcy
or insolvency of a contracting party.
The Distribution Agreement provides that Cohesion will have exclusive
distribution rights to the Company's 3.5mm, 2.8mm and 1.9mm ROC suture fasteners
and collagen-based products developed under the Research and Development
Agreement which are labeled for facial plastic surgery or dermatology
applications. Under the agreement, the Company will have exclusive distribution
rights to collagen-based products developed under the Research and Development
Agreement which are labeled for orthopaedic applications. Each party must sell
a minimum number of units of products in its exclusive field to maintain
exclusivity; otherwise, the other party gains co-exclusive rights to market and
distribute products in that field. Under the agreement, a distributing party
will purchase products from a manufacturing party at various discounts from the
actual average selling price of the products, and Cohesion is required to pay
royalties to the Company with respect to Cohesion's net sales of products for
which development was funded by the Company pursuant to the Research and
Development Agreement.
Patents and Proprietary Technology
The Company believes that a key element of its competitive advantage depends on
its ability to develop and maintain proprietary aspects of its technology. To
this end, the Company files patent applications to protect technology,
inventions and improvements that it believes are significant to the growth of
its business. As of March 24, 1999 the Company had 33 issued patents and more
than 22 U.S. and foreign patent applications pending. As of March 24, 1999 the
Company had rights to license products under 26 issued patents and patents
pending. These issued patents and pending patent applications cover its radial
osteo compression (ROC) technology, it's COR cartilage repair technology,
meniscal repair systems, suture systems, ACL repair systems and various surgical
tools, systems and methods.
On October 28, 1998, Bionx Implants, Inc., Bionx Implants, Oy. and Dr. Saul N.
Schreiber ("Bionx") filed suit against the Company in the United States District
Court for the District of Massachusetts alleging that the Company's Clearfix(TM)
Meniscal Dart product infringed a Bionx patent. On March 24, 1999, Judge
Gertner of that Court denied Bionx's motion for a preliminary injunction which
would have precluded Innovasive from manufacturing, using or selling the
Meniscal Dart on the grounds that Bionx was unlikely to succeed on the merits of
its infringement claim. The Company does not believe that the Meniscal Dart
infringes the Bionx patent and intends to continue to manufacture and sell the
Meniscal Dart product and to vigorously defend its
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position with respect to the Bionx claim. However, there can be no assurance
that current and potential competitors and other third parties have not filed or
in the future will not file applications for, or have not received or in the
future will not receive, patents and will not obtain additional proprietary
rights relating to materials or processes used or proposed to be used by the
Company. Accordingly, there can be no assurance that the Company's products have
not, do not or will not infringe any patents or other proprietary rights of
third parties.
The Company typically requires its employees, consultants and advisors to
execute confidentiality agreements in connection with their employment,
consulting or advisory relationships with the Company. The Company also
typically requires its employees, consultants and certain advisors to agree to
disclose and assign to the Company all inventions conceived of on Company time,
using Company property or which relate to the Company's business. There can be
no assurance, however, that the foregoing agreements will effectively prevent
disclosure of the Company's confidential information or provide meaningful
protection for the Company's confidential information if there is unauthorized
use or disclosure. Furthermore, no assurance can be given that competitors will
not independently develop substantially equivalent proprietary information and
techniques or otherwise gain access to the Company's proprietary technology.
Competition
The Company faces strong competition in the marketplace from soft tissue
fixation devices for knee and shoulder applications sold by large corporations
with orthopaedic divisions. Mitek Surgical Products, Inc. ("Mitek"), a division
of Johnson & Johnson, the Zimmer division of Bristol-Meyers Squibb Company, the
Linvatec division of ConMed Inc., Smith & Nephew Endoscopy, ("Dyonics" and
"Acufex") subsidiaries of Smith & Nephew, Inc., Arthrotek Inc., a division of
Biomet, Inc. and Arthrex, Inc. all compete in the Company's market with metal
suture anchors and devices for arthroscopic soft tissue reconstruction of the
knee. These competitors have significantly greater financial, manufacturing,
marketing, distribution and technical resources than the Company. Mitek, which
sells metal barbed anchors and bioabsorbable bone anchors, currently has the
largest share of the suture fastener market. The Company also faces competition
from smaller companies including Bionx, Inc. and Orthopaedic Biosystems Ltd.,
Inc.
The Company believes that its suture fastener products compete favorably against
its competition based on a number of factors, including the Company's
proprietary radial osteo compression design which permits excellent holding
strength in both large and small bones and can be modeled from plastic,
bioabsorbable polymers and biomaterials; the revisability of the Company's
fasteners; the availability of a proprietary arthroscopic delivery system
without the need to tie suture knots for its products; and the small profile of
the Company's products when inserted into bone, which permits its fasteners to
be deployed in the small bones of the wrist, hand, ankle and foot. Furthermore,
the Company believes that its products compete favorably against its competition
in soft tissue reconstruction of the knee based on a number of factors,
including the Company's proprietary ACL ligament fastener devices and meniscal
repair devices for soft tissue reconstruction which can be modeled from plastic
and bioabsorbable polymers. However, there can be no assurance that the
Company's competitors will not succeed in developing products and technologies
that are more effective or less costly than those that have been or may be
developed by the Company.
Government Regulation
Clinical testing, manufacture and sale of the Company's products are subject to
regulation by the FDA and corresponding state and foreign regulatory agencies.
Pursuant to the Federal Food, Drug, and Cosmetic Act, and the regulations
promulgated thereunder, the FDA regulates the clinical testing, design,
manufacture, labeling, distribution and promotion of medical devices.
Noncompliance with applicable requirements can result in, among other things,
fines, injunctions, civil penalties, recall or seizure of products, total or
partial suspension of production, failure of the government to grant pre-market
clearance or pre-market approval for
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devices, withdrawal of marketing approvals and criminal prosecution. The FDA
also has the authority to request repair, replacement or refund of the cost of
any device manufactured or distributed by the Company.
In the United States, medical devices are classified into one of three classes
(i.e., Class I, II, or III) on the basis of the controls deemed necessary by the
FDA to reasonably ensure their safety and effectiveness. Class I devices are
generally exempt from the premarket notification (510(K)) and premarket approval
regulations. Class II devices are subject to general and special controls (e.g.,
performance standards, postmarket surveillance, patient registries and FDA
guidelines). Generally, Class III devices are those which must receive
premarket approval by the FDA to ensure their safety and effectiveness (e.g.,
life-sustaining, life-supporting and implantable devices, or new devices which
have been found not to be substantially equivalent to legally marketed devices).
Before a new device can be introduced in the market, the Company must generally
obtain FDA clearance through a 510(k) notification or approval of a Premarket
Approval ("PMA"). A 510(k) clearance will be granted if the submitted
information establishes that the proposed device is "substantially equivalent"
to a legally marketed Class I or Class II medical device or a Class III medical
device for which the FDA has not called for PMAs. The FDA recently has been
requiring more rigorous demonstration of substantial equivalence than in the
past, including in some cases requiring submission of clinical trial data. The
FDA may determine that the proposed device is not substantially equivalent to a
predicate device or that additional information is needed before a substantial
equivalence determination can be made. It generally takes from four to twelve
months from submission to obtain 510(k) premarket clearance, however the process
may take longer. The FDA may determine that a proposed device is not
substantially equivalent to a legally marketed device or that additional
information is needed before a substantial equivalence determination can be
made. A "not substantially equivalent" determination or a request for
additional information could prevent or delay the market introduction of new
products that fall into this category and could have a material adverse effect
on the Company's business, financial condition or results of operations. For
any of the Company's devices that are cleared through the 510(k) process,
modifications or enhancements that could significantly affect the safety or
effectiveness of the device or that constitute a major change to the intended
use of the device will require a new 510(k) submission.
A PMA application must be filed if a proposed device is not substantially
equivalent to a legally marketed Class I or Class II device, or if it is a Class
III device for which the FDA has called for PMAs. A PMA application must be
supported by valid scientific evidence which typically includes extensive
information (including relevant bench tests, laboratory and animal studies and
clinical trial data) to demonstrate the safety and effectiveness of the device.
The PMA application also must contain a complete description of the device and
its components; a detailed description of the methods, facilities and controls
used to manufacture the device; and the proposed labeling, advertising
literature and training materials (if any). The PMA process can be expensive,
uncertain and lengthy. A number of devices for which FDA approval has been
sought by other companies have never been approved for marketing. Modifications
to a device that is the subject of an approved PMA, its labeling, or
manufacturing process may require approval by the FDA or PMA supplements or new
PMAs.
If human clinical trials of a device are required and the device presents a
"significant risk," the sponsor of the trial (usually the manufacturer or the
distributor of the device) will have to file an Investigational Device Exemption
("IDE") application prior to commencing human clinical trials. The IDE
application must be supported by data, typically including the results of animal
and laboratory testing. If the IDE application is approved by the FDA and one or
more appropriate Institutional Review Boards ("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 "nonsignificant risk"
to the patient, a sponsor may begin the clinical trial after obtaining approval
for the study by one or more appropriate IRBs without the need for FDA approval.
Sponsors of clinical trials are permitted to sell investigational devices
distributed in the course of the study provided that compensation does not
exceed recovery of the costs of manufacture, research, development and handling.
An IDE supplement must
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be submitted to and approved by the FDA before a sponsor or investigator may
make a change to the investigational plan that may affect its scientific
soundness or the rights, safety or welfare of human subjects.
To date, all of the Company's products have received 510(k) clearance or have
been exempted by the FDA from the 510(k) clearance process. The Company has
made modifications to its devices which the Company believes do not require the
submission of new 510(k) notices. There can be no assurance, however, that the
FDA would agree with any of the Company's determinations not to submit a new
510(k) notice for any device modification, or would not require the Company to
submit a new 510(k) notice for any of the changes made to the device. If the
FDA requires the Company to submit a new 510(k) notice for any device
modification, the Company may be prohibited from marketing the modified device
until the 510(k) notice is cleared by the FDA. There can be no assurance that
any proposed modification will be cleared on a timely basis, if at all.
There can be no assurance the FDA will not determine that the Company's future
products must adhere to the more costly, lengthy, and uncertain PMA approval
process. There also can be no assurance that the Company will obtain FDA
clearance or approval for such future products on a timely basis, if at all, or
that the FDA will not impose limitations on the intended use of such products as
a condition of clearance or approval. Any delay in receipt of, failure to
obtain, or limitations on clearance or approval could have a material adverse
effect on the Company's business, financial condition or results of operation.
Any devices manufactured or distributed by the Company pursuant to FDA
clearances or approvals are subject to pervasive and continuing regulation by
the FDA and certain state agencies. Manufacturers of medical devices for
marketing in the United States are required to adhere to applicable regulations
setting forth detailed Good Manufacturing Practices ("GMP") requirements, which
include design, testing, control and documentation requirements. Manufacturers
must also comply with Medical Devices Reporting ("MDR") requirements that a firm
reports to the FDA any incident in which its product may have caused or
contributed to a death or serious injury, or in which its product malfunctioned
and, if the malfunction were to recur, it would be likely to cause or contribute
to a death or serious injury. Labeling and promotional activities are subject
to scrutiny by the FDA and, in certain circumstances, by the Federal Trade
Commission. Current FDA enforcement policy prohibits the marketing of approved
medical devices for unapproved uses.
The Company is also subject to regulation in each of the foreign countries in
which it sells its products in the areas of product standards, packaging
requirements, labeling requirements, import restrictions, tariff regulations,
duties and tax requirements. Many of the regulations applicable to the
Company's products in these countries are similar to those of the FDA. The
national health organization of some countries require the Company's products to
be qualified before they can be marketed in those countries. The Company relies
on its international distributors to comply with these requirements. To date,
the Company has not experienced significant difficulty in complying with these
regulations.
The Company has implemented policies and procedures which has allowed the
Company to receive ISO 9001 registration and EN 46001 certification. These
standards for quality systems in manufacturing have been developed to ensure
that companies know, on a worldwide basis, the standards of quality to which
they will be held. The European Union has promulgated rules which require that
medical products receive the CE mark before entering the European market. The CE
mark is an international symbol of quality and compliance with applicable
European medical device directives. As of March 24, 1999 the Company has
received CE Mark approval for substantially all of its principal products. There
can be no assurance that the Company will be successful in meeting the
continuing certification requirements for these products. There can also be no
assurance that the Company will be successful in meeting the certification
requirements for future product introductions.
The Company is subject to numerous federal, state and local laws relating to
such matters as safe working conditions and environmental protection. There can
be no assurance that the Company will not be required to incur significant costs
to comply with such laws and regulations in the future or that such laws or
regulations
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will not have a material adverse effect on the Company's business, financial
condition or results of operations.
Product Liability and Insurance
Medical device companies are subject to an inherent risk of product liability
and other liability claims in the event that the use of their products results
in personal injury. The Company maintains liability insurance coverage in the
amounts deemed appropriate by management based upon the nature and risks of its
business in general and its actual experience to date. There can be no
assurance that a future claim will not exceed insurance coverage or that such
coverage will continue to be available. In addition, any substantial increase
in the cost of such insurance could have a material adverse effect on the
Company's business, financial condition and results of operations.
Employees
As of February 28, 1999, the Company has 131 employees, 25 of whom were engaged
in research and development and regulatory, 50 in manufacturing and quality
assurance and 56 in marketing, sales and administrative positions. The Company
also contracts with outside consultants. None of the Company's employees is
covered by a collective bargaining agreement. The Company believes that it
maintains good relations with its employees.
11
<PAGE>
Item 2. Properties
As of December 31, 1998, the Company leased the following facilities:
<TABLE>
<CAPTION>
Appx. Square
Location Type of Facility Footage
<S> <C> <C>
Marlborough, MA...................... Executive Offices, Research and Development, 28,000
Manufacturing, Warehousing and Distribution
Attleboro, MA........................ Research and Development 2,500
Logan, UT............................ Research and Development , Manufacturing 12,500
</TABLE>
Item 3. Legal Proceedings
On October 28, 1998, Bionx Implants, Inc., Bionx Implants, Oy. and Dr. Saul N.
Schreiber ("Bionx") filed suit against the Company in the United States District
Court for the District of Massachusetts alleging that the Company's Clearfix(TM)
Meniscal Dart product infringed a Bionx patent. On March 24, 1999, Judge
Gertner of that Court denied Bionx's motion for a preliminary injunction which
would have precluded Innovasive from manufacturing, using or selling the
Meniscal Dart on the grounds that Bionx was unlikely to succeed on the merits of
its infringement claim. The Bionx claim does not allege any infringement with
respect to the Company's Meniscal Screw, which was commercially launched in
October 1998. The Company believes that the Bionx claim is without merit and
intends to continue to defend itself vigorously.
Item 4. Submission of Matters to a Vote of Security Holders
None.
12
<PAGE>
Part II
Item 5. Market for Registrant's Common Equity and Related Stockholder Matters
The Company's common stock is traded in the over-the-counter market on The
NASDAQ National Market under the symbol IDEA. The table below lists the
quarterly range of the high and low per share closing bids of the Company's
Common Stock on the NASDAQ National Market during the periods indicated.
<TABLE>
<CAPTION>
FISCAL PERIOD HIGH LOW
- ------------- ---- ---
<S> <C> <C>
First Quarter - 1998 $11.00 $8.00
Second Quarter - 1998 $10.63 $8.63
Third Quarter - 1998 $ 9.50 $5.25
Fourth Quarter - 1998 $ 5.00 $2.38
</TABLE>
The Company has never declared or paid any cash dividends on its Common Stock.
The Company currently intends to retain all future earnings for the operation
and expansion of its business and therefore does not anticipate paying any cash
dividends in the foreseeable future.
On March 25, 1999 there were 98 stockholders of record of the Company's common
stock.
13
<PAGE>
Item 6. Selected Financial Data
<TABLE>
<CAPTION>
Years Ended December 31,
------------------------------------------------------------------------------------
1998 1997 1996 1995 1994
--------------- --------------- --------------- --------------- ---------------
<S> <C> <C> <C> <C> <C>
(in thousands, except per share data)
Statement of Operations Data:
Net sales $ 11,911 $ 7,754 $ 4,353 $ 1,234 $ 244
Cost of sales 3,339 2,232 1,611 1,000 465
-------- -------- ------- ------- -------
Gross profit (loss) 8,572 5,522 2,742 234 (221)
Selling, general and administrative
expenses 11,294 8,407 4,922 2,435 1,533
Purchased in-process research and
Development (1) - 13,370 - - -
Research and development
expenses (2) 4,290 3,952 2,667 1,597 1,172
-------- -------- ------- ------- -------
Loss from operations ( 7,012) (20,207) (4,847) (3,798) (2,926)
Interest income 513 1,053 785 64 34
-------- -------- ------- ------- -------
Net loss $ (6,499) $(19,154) $(4,062) $(3,734) $(2,892)
======== ======== ======= ======= =======
Basic and diluted net loss per share $(0.71) $(2.33) $(0.83) $(2.06) $(1.79)
======== ======== ======= ======= =======
Shares used in computing basic and
diluted net loss per share (3) 9,179 8,225 4,911 1,811 1,621
======== ======== ======= ======= =======
<CAPTION>
December 31,
----------------------------------------------------------------------------
1998 1997 1996 1995 1994
-------- -------- ------- ------- -------
(in thousands)
<S> <C> <C> <C> <C> <C>
Balance Sheet Data:
Cash and cash equivalents $ 3,724 $ 2,916 $12,825 $ 5,052 $ 2,051
Working capital 9,882 15,885 22,841 4,857 1,628
Total assets 16,059 21,520 25,363 6,399 3,099
Mandatorily redeemable convertible
preferred stock - - - 13,970 6,993
Stockholders' equity (deficit) $ 13,214 $ 19,197 $23,788 $(8,501) $(4,759)
</TABLE>
(1) See Note 2 of Notes to Financial Statements.
(2) Includes research and development costs payable to a related party of $60
in 1998, $428 in 1997 and $664 in 1996.
(3) See Note 1 of Notes to Financial Statements.
14
<PAGE>
Item 7. Management's Discussion and Analysis of Financial Condition and Results
of Operation
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Overview
Since its inception in 1990, the Company has been primarily engaged in the
development, manufacture and marketing of proprietary devices and
instrumentation which facilitate the reattachment of soft tissue structures,
such as ligaments and tendons, to bones and other tissues. The Company has a
limited operating history and as of December 31, 1998 had an accumulated deficit
of $41.7 million. These losses have resulted principally from expenses
associated to fund research and development, the establishment of its
manufacturing capabilities and the expansion of its marketing and sales
organization. On June 27, 1997, the Company acquired substantially all of the
assets, including intellectual property related to orthopaedic medicine, and
assumed substantially all of the liabilities of MedicineLodge, Inc., a Delaware
corporation ("MLI") in exchange for 1,885,000 shares of the Company's common
stock. MLI was a privately held designer, developer and manufacturer of
orthopaedic medical devices, particularly implantable systems and related
instrumentation used in minimally invasive arthroscopic procedures to repair
injuries to the knee. A portion of the purchase price was allocated to in-
process research and development, resulting in a charge to the Company's
operations of $13.4 million.
Although the Company's sales were principally derived from the sale of its
family of shoulder related products, the Company now markets five product
platforms: suture anchors, suturing systems, cartilage repair products, anterior
cruciate ligament ("ACL") reconstruction products and its newly introduced
meniscal repair products. Within these product platforms, the Company released
six new product lines in 1998. Included in these six releases were two product
lines that represent the Company's first offerings using bioabsorbable
materials, the BioROC and the Clearfix Meniscal Screw.
The Company's line of suture anchors was expanded in March 1998 with the release
of the BioROC, a bioabsorbable suture anchor which degrades and absorbs into the
surrounding bone and tissue after the repaired tissue has sufficiently healed
back to the bone. Two new product lines were introduced within the suturing
systems product line: the Y-Knot, a device used in place of traditional knot
configurations when securing soft tissue to bone and the Cuff Guard, a suture
with an expanded surface area. The Company introduced two new ACL reconstruction
product lines in 1998: the Transverse Fixation System, an ACL repair system
which provides femoral fixation of hamstring tendon grafts and a general ACL
Repair System used in both patellar tendon and hamstring tendon ACL
reconstruction procedures. In October 1998, the Company announced the commercial
release of its Clearfix Meniscal Screw, a bioabsorbable device used to repair
traumatic tears within the meniscus of the knee through a minimally invasive
arthroscopic approach.
The following information should be read in conjunction with the Financial
Statements and notes thereto and Management's Discussion and Analysis of
Financial Condition and Results of Operations contained in this Annual Report.
Any statements in this report expressing the beliefs and expectations of
management regarding the Company's future results and performance are forward-
looking statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements are based on current
expectations that involve a number of risks and uncertainties. The Company
wishes to caution readers not to place undue reliance on any such forward-
looking statements, which speak only as of the date made. Such forward looking
statements are subject to certain risks and uncertainties that could cause
actual results to differ materially from historical results and those presently
anticipated or projected. These risks include the receipt of regulatory
approvals, progress of product development programs, manufacturing of higher
volume product
15
<PAGE>
requirements, clinical efficacy of and market demand for the products and the
establishment of an effective distribution channel. Certain of such risks and
uncertainties are described in Exhibit 99 of this Annual Report.
Results of Operations
Years Ended December 31, 1998 and 1997
Net sales increased to $11.9 million for the year ended December 31, 1998 from
$7.8 million for the year ended December 31, 1997. Sales of the Company's
shoulder related products increased to $8.0 million for the year ended December
31, 1998 from $5.9 million in the prior year. Shoulder related products
include the Company's suture anchor and suturing system product lines. Suture
anchor products increased in 1998 over the prior year primarily as a result of
incremental sales generated from the BioROC, released in the first quarter of
1998. The BioROC is a bioabsorbable suture anchor which degrades and absorbs
into the surrounding bone and tissue after the repaired tissue has sufficiently
healed back to the bone. The Company also experienced increased sales in its
existing suture anchor offerings including its ROC EZ and ROC XS suture anchors.
The suture systems product platform experienced sales growth in 1998 with
increased sales contributions from the Suture Grasper, Cuff Link, Y-Knot and
Cuff Guard product lines. Sales of knee related products increased to $3.7
million for the year ended December 31, 1998 from $1.7 million in the prior
year. Knee related products include the Company's ACL repair, cartilage repair
and meniscal repair product platforms. The Company's ACL product offerings were
primarily introduced in the fourth quarter of 1997 and the first quarter of
1998. Significant contributors to ACL product sales in 1998 were: the Linx HT,
a product released in the fourth quarter of 1997 which facilitates femoral
fixation in ACL repair with the use of hamstring tendon grafts, the Geofit Screw
and Washer System, used in tibial fixation of hamstring tendon grafts and the
Transverse Fixation System, released in the first quarter of 1998 and also used
in femoral fixation of hamstring tendon grafts. Sales of the Company's COR
system, used to repair osteochondral defects in the knee, also experienced sales
growth over the prior year. In the fourth quarter of 1998, the Company
announced the commercial release of its Clearfix Meniscal Screw, a bioabsorbable
device used to repair traumatic tears within the meniscus of the knee through a
minimally invasive arthroscopic approach. Sales of the meniscal product
commenced in the fourth quarter of 1998 and also contributed to the overall knee
related product growth as compared to the prior year.
Domestic sales increased to $9.9 million for the year ended December 31, 1998
from $6.6 million in the prior year. This sales growth was attributable to an
increase in the unit sales and expansion of the Company's line of shoulder and
knee related product offerings and the expansion of the Company's direct sales
force and domestic distribution network.
International sales, which are denominated in US dollars, increased to $2.0
million for the year ended December 31, 1998 from $1.1 million in the prior
year. This increase was primarily attributable to the expansion of the
Company's international distribution network as well as an increase in the unit
sales and expansion of the Company's line of shoulder and knee related product
offerings. In the second quarter of 1998, the Company announced the appointment
of Protek GmbH, a division of Sulzer Orthopaedics, and Stryker Canada, Inc. as
distributors for the Company's products in Germany and Canada, respectively.
Gross profit increased to $8.6 million for the year ended December 31, 1998 from
$5.5 million in the prior year. As a percentage of net sales, gross profit
increased to 72% for the year ended December 31, 1998 from 71% in the prior
year. The increase in gross profit was primarily due to the increased improved
manufacturing efficiencies resulting from increased production volumes.
Selling, general and administrative expenses increased to $11.3 million for the
year ended December 31, 1998 from $8.4 million for the year ended December 31,
1997. The increase resulted partially from higher commission expense on the
increased sales volume and the expansion of the domestic direct sales force and
external distribution network. The Company also experienced increases in
clinical training costs of its direct
16
<PAGE>
sales force and external distributors due to the volume of new products
introduced in 1998. Legal fees also increased over the prior year primarily as a
result of costs related to the Company's response to a patent infringement suit
filed against the Company by Bionx, Inc. Increased costs were also incurred in
the following areas: salary and travel, product sample expenses, product
advertising, depreciation and incremental administrative costs resulting from
the acquisition of MLI on June 27, 1997.
Research and development expenses increased to $4.3 million for the year ended
December 31, 1998 from $4.0 million for the year ended December 31, 1997. The
increase was a result of incremental costs resulting from the acquisition of MLI
on June 27, 1997 as well as an increase in the non-cash compensation charge
related to the grant of stock options to the Company's Scientific Advisory
Board. Offsetting this increase was a reduction in costs relating to a joint
product development project undertaken with Cohesion Technologies (as assigned
from Collagen Corporation).
As a result of the Company's transaction with MLI in the second quarter of 1997,
the Company incurred a non-recurring charge to operations of $13,370,000
representing the portion of the purchase price allocated to in-process research
and development.
Net interest income decreased to $513,000 for the year ended December 31, 1998
from $1.1 million for the year ended December 31, 1997 primarily as a result of
investment returns earned on lower average cash balances maintained during the
year.
As a result of the foregoing, the net loss decreased $6.5 million for the year
ended December 31, 1998 from $19.2 million for the year ended December 31, 1997.
Years Ended December 31, 1997 and 1996
Net sales increased to $7.8 million for the year ended December 31, 1997 from
$4.4 million for the year ended December 31, 1996. Sales of shoulder related
products, including the Company's family of ROC suture fasteners, suture systems
and related surgical instrumentation increased to $5.9 million for the year
ended December 31, 1997 from $4.1 million in the prior year. In June 1997, the
Company introduced the ROC EZ, an improved version of the original ROC fastener
used in hardbone applications, and the CuffLink, used to augment tunnels made in
the bone for rotator cuff repair procedures. Sales of the Company's knee related
products increased to $1.7 million for the year ended December 31, 1997 from
$0.3 million in the prior year. The COR system, introduced in October 1996,
used to repair osteochondral defects in the knee, and the Linx HT, introduced in
December 1997, used to facilitate repair of the ACL, both contributed to the
increase in knee related products for the year ended December 31, 1997 over the
prior year.
Domestic sales increased to $6.6 million for the year ended December 31, 1997
from $3.2 million in the prior year. The increase was attributable to an
increase in the unit sales and expansion of the Company's line of shoulder and
knee related product offerings and the expansion of the Company's direct sales
force and domestic distribution network.
International sales, which are denominated in US dollars, decreased to $1.1
million for the year ended December 31, 1997 from $1.2 million in the prior
year. The decrease was primarily a result of a delay in the regulatory process
for the release of the ROC EZ in certain international markets and a transition
of an international distributor.
Gross profit increased to $5.5 million for the year ended December 31, 1997 from
$2.7 million in the prior year. As a percentage of net sales, gross profit
increased to 71% for the year ended December 31, 1997 from 63% for the year
ended December 31, 1996. The increase in gross profit was primarily due to the
increased sales of higher margin implants and the efficiencies resulting from
increased production volumes.
17
<PAGE>
Selling, general and administrative expenses increased to $8.4 million for the
year ended December 31, 1997 from $4.9 million for the year ended December 31,
1996. The increase resulted primarily from higher commission expense on the
increased sales volume and the expansion of the domestic direct sales force and
external distribution network. The Company also experienced cost increases in
the following areas: salary and travel, product sample expenses, product
advertising, depreciation and incremental administrative costs resulting from
the acquisition of MLI on June 27, 1997.
Research and development expenses increased to $4.0 million for the year ended
December 31, 1997 from $2.7 million for the year ended December 31, 1996. The
increase was primarily attributable to the following: research and development
costs incurred by MLI to support research projects in process at the time of the
acquisition, product development costs in support of the Company's meniscal
repair and bioabsorbable programs, compensation related to the grant of stock
options and patent preparation and filing costs.
As a result of the Company's transaction with MLI, the Company incurred a charge
to operations of $13,370,000 representing the portion of the purchase price
allocated to in-process research and development.
Net interest income increased to $1.1 million for the year ended December 31,
1997 from $785,000 for the year ended December 31, 1996. The primary reason for
the increase was due to investment returns earned on higher average cash
balances resulting from the proceeds of the initial public offering closed
during the second quarter of 1996.
As a result of the foregoing, the net loss increased to $19.2 million for the
year ended December 31, 1997 from $4.1 million for the year ended December 31,
1996.
Liquidity and Capital Resources
As of December 31, 1998, the Company had cash, cash equivalents and marketable
securities of $4.8 million as compared to a balance of $13.5 million on December
31, 1997. Working capital decreased to $9.9 million from $15.9 million in
1997.
Cash used in the Company's operations increased to $7.8 million for the year
ended December 31, 1998 from $7.3 million in 1997. The net loss in 1998
decreased to $6.5 million from $19.2 million in the prior year (which included a
$13.4 million non-cash charge for in-process research and development resulting
from the MLI transaction). Accounts receivable increased to $2.2 million in
1998 from $1.6 million in 1997 as a result of increased sales volume.
Inventories increased to $5.6 million in 1998 from $2.9 million in 1997. The
increase was primarily attributable to the expansion of the Company's product
lines and increased inventory requirements to support planned sales volumes.
Cash provided by investing activities totaled $8.4 million in 1998 resulting
from capital expenditures of $1.1 million and net redemptions of marketable
securities of $9.5 million.
Cash provided by financing activities totaled $162,000 in 1998 resulting
primarily from proceeds received from the issuance of common stock pursuant to
the Company's Employee Stock Purchase Plan.
On December 31, 1998, the Company entered into a working capital line of credit
with a bank, that provides the Company with a maximum borrowing availability of
$2.5 million, limited by certain receivable and inventory balances. Borrowings
under this agreement bear interest at the prime rate. The line of credit expires
and all outstanding amounts thereunder are due December 31, 1999. Under the
line of credit, the Company is obligated to comply with certain financial
covenants. There were no borrowing outstanding under the line of credit at
December 31, 1998.
18
<PAGE>
The Company's future liquidity and capital requirements will depend upon the
progress of research and development programs, regulatory matters and the
expansion of its manufacturing capabilities to satisfy increasing volume
requirements. In addition, the Company's capital requirements will depend upon,
among other factors, the timing of the establishment of effective sales channels
in the United States and abroad and the extent to which the Company's products
gain market acceptance resulting in increased sales sufficient to generate a
profit from operations. Therefore the Company cannot provide assurances that it
will not require additional financing in the future. If additional financing is
necessary, the Company would seek to raise these funds through bank facilities
or debt or equity offerings. There can be no assurance that such funds would be
available on terms acceptable to the Company.
Impact of the Year 2000 Issue
The year 2000 issue is the result of computer programs being written using two
digits rather than four to define the applicable year. Any computer programs
that have date-sensitive software may recognize a date using "00" as the year
1900 rather than the year 2000. This could result in a system failure or
miscalculations causing disruptions of operations, including, among other
things, a temporary inability to process transactions, send invoices, or engage
in similar normal business activities.
The Company believes that its primary business and research and development
systems will be Y2K compliant by the second quarter of 1999 based on it's
internal evaluations and testing of these systems. The Company does not rely
materially on non-IT related technology in its manufacturing processes and
thereby does not anticipate that Y2K issues will affect its ability to
manufacture finished goods. The Company has begun the process of developing a
communication strategy for third party vendors and intends to issue
questionnaires that will address Y2K compliance. The Company anticipates that
its assessment of third party vendors will be completed by the second quarter of
1999. The Company does not anticipate incurring additional costs outside of the
scope of its current IT budget to complete future testing and compliance
activities.
The Company relies extensively on third party suppliers. Because their systems
are not directly under the Company's control, the Company is at risk that all
required external Y2K compliance efforts will not be completed on a timely
basis. In the event that the Company's significant suppliers do not
successfully and timely achieve Y2K compliance, and the Company is unable to
replace them with alternate suppliers, the Company's operations could be
adversely affected.
At this time, the Company believes that the Y2K problem will not pose
significant operational problems for the Company's computer systems. Since no
significant issues have arisen, the Company does not have a contingency plan to
address any material Y2K issues. If significant Y2K issues arise, the Company
may not be able to timely develop and implement a contingency plan and the
Company's operations could be adversely affected.
The disclosure in this Section is a Y2K Readiness Disclosure under the Year 2000
Information and Readiness Disclosure Act of 1998.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
The Company is exposed to the impact of interest rate changes and the change in
the market values of its investments. The Company's exposure to market rate risk
for changes in interest rates relates primarily to the Company's investment
portfolio. The Company has not used derivative financial instruments in its
investment portfolio. The Company invests its excess cash in money market
accounts, debt instruments of the U.S. Government and its agencies and in high-
quality corporate issuers and, by policy, limits the amount of credit exposure
to any one issuer.
The Company protects and preserves its invested funds by limiting default,
market and reinvestment risk.
Investments in both fixed rate and floating rate interest earning instruments
carries a degree of interest rate risk. Fixed rate securities may have their
fair market value adversely impacted due to a rise in interest rates, while
floating rate securities may produce less income than expected if interest rates
fall. Due in part to these factors, the Company's future investment income may
fall short of expectations due to changes in interest rates or the Company may
suffer losses in principal if forced to sell securities which have declined in
market value due to changes in interest rates.
The amortized cost of the Company's investment approximate fair market value and
consists of $1.9 million of money market investments and $2.8 million of
corporate debt securities due in less than one year. The average interest rate
on these investments at December 31, 1998 was approximately 5.23%.
19
<PAGE>
Item 8. Financial Statements and Supplementary Data
INNOVASIVE DEVICES, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
<TABLE>
<CAPTION>
Page
---------
<S> <C>
Report of Independent Accountants 21
Consolidated Balance Sheet at December 31, 1998 and 1997 22
Consolidated Statement of Operations for the three years ended 23
December 31, 1998
Consolidated Statement of Stockholders' Equity (Deficit) for the 24
three years ended December 31, 1998
Consolidated Statement of Cash Flows for the three years ended 25
December 31, 1998
Notes to Consolidated Financial Statements 26
Financial Statement Schedule:
II. Valuation and Qualifying Accounts and Reserves for the three 42
years ended December 31, 1998
</TABLE>
All other schedules are omitted because they are not applicable.
20
<PAGE>
REPORT OF INDEPENDENT ACCOUNTANTS
To the Board of Directors and
Stockholders of Innovasive Devices, Inc.
In our opinion, the consolidated financial statements listed in the accompanying
index present fairly, in all material respects, the financial position of
Innovasive Devices, Inc. and its subsidiary at December 31, 1998 and 1997, and
the results of their operations and their cash flows for each of the three years
in the period ended December 31, 1998, in conformity with generally accepted
accounting principles. These financial statements are the responsibility of the
Company's management; our responsibility is to express an opinion on these
financial statements based on our audits. We conducted our audits of these
statements in accordance with generally accepted auditing standards which
require that we plan and perform the audit to obtain reasonable assurance about
whether the financial statements are free of material misstatement. An audit
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 the opinion expressed above.
PricewaterhouseCoopers LLP
Boston, Massachusetts
February 18, 1999
21
<PAGE>
INNOVASIVE DEVICES, INC.
CONSOLIDATED BALANCE SHEET
(In thousands, except share data)
<TABLE>
<CAPTION>
ASSETS December 31,
-------------------------
1998 1997
---------- ----------
<S> <C> <C>
Current assets:
Cash and cash equivalents $ 3,724 $ 2,916
Marketable securities 1,043 10,604
Accounts receivable, net of allowance for
doubtful accounts of $140 and $121 at
December 31, 1998 and 1997, respectively 2,189 1,625
Inventories 5,596 2,947
Prepaid expenses 175 116
---------- ----------
Total current assets 12,727 18,208
Fixed assets, net 2,212 1,960
Goodwill, net 1,093 1,326
Other assets 27 26
---------- ----------
$ 16,059 $ 21,520
========== ==========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 682 $ 809
Accounts payable to related party 60 392
Accrued expenses 2,103 1,122
---------- ----------
Total current liabilities 2,845 2,323
---------- ----------
Stockholders' equity:
Common stock, $.0001 par value;
Shares authorized: 15,000,000;
Shares issued and outstanding: 9,207,250 and
9,164,848 at December 31, 1998 and 1997, respectively 1 1
Additional paid-in capital 54,918 54,702
Accumulated deficit (41,655) (35,156)
Deferred compensation (50) (350)
---------- ----------
Total stockholders' equity 13,214 19,197
---------- ----------
Commitments (Note 14) - -
---------- ----------
$ 16,059 $ 21,520
========== ==========
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements.
22
<PAGE>
INNOVASIVE DEVICES, INC.
CONSOLIDATED STATEMENT OF OPERATIONS
(In thousands, except per share data)
<TABLE>
<CAPTION>
Year Ended December 31,
-------------------------------------
1998 1997 1996
----------- ---------- ----------
<S> <C> <C> <C>
Net sales $ 11,911 $ 7,754 $ 4,353
Cost of sales 3,339 2,232 1,611
---------- --------- ---------
Gross profit 8,572 5,522 2,742
Selling, general and administrative expenses 11,294 8,407 4,922
Research and development 4,230 3,524 2,003
Research and development - related party 60 428 664
Purchased in-process research and
development - 13,370 -
---------- --------- ---------
Loss from operations ( 7,012) (20,207) (4,847)
Interest income 513 1,053 785
---------- --------- ---------
Net loss $ (6,499) $(19,154) $ (4,062)
========== ========= =========
Basic and diluted net loss
per share (Note 1) $( 0.71) $( 2.33) $( 0.83)
========== ========= =========
Shares used in computing basic and
diluted net loss per share 9,179 8,225 4,911
========== ========= =========
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements.
23
<PAGE>
INNOVASIVE DEVICES, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT)
(In thousands, except share data)
<TABLE>
<CAPTION>
Common Stock
------------------
Number Additional Total
of Par paid-in Accumulated Treasury Deferred stockholders'
shares value capital deficit stock compensation equity (deficit)
--------- ----- ---------- ------------ --------- ------------- ----------------
<S> <C> <C> <C> <C> <C> <C> <C>
Balance at December 31, 1995 1,815,922 $1 $ 3,459 $(11,936) $(25) $ - $ (8,501)
Accretion of Series A and
Series B mandatorily
redeemable preferred stock
to redemption value (4) (4)
Issuance of common stock
under stock option plan 5,111 - 9 9
Conversion of Series A and
Series B mandatorily
redeemable preferred stock
into common stock -
(Note 9) 3,543,819 14,901 14,901
Issuance of common stock,
net of issuance costs of
$2,305 1,895,556 - 21,420 25 21,445
Net loss (4,062) (4,062)
--------------------------------------------------------------------------------------------------
Balance at December 31, 1996 7,260,408 1 39,789 (16,002) - - 23,788
Issuance of common stock
under stock option plan 9,940 - 35 35
Issuance of common stock -
acquisition of business
(Note 2) 1,885,000 - 14,326 14,326
Issuance of common stock
under employee stock
purchase plan (Note 11) 9,500 - 82 82
Compensation related to the
grant of common stock
options 470 (470) -
Amortization of deferred
compensation 120 120
Net loss (19,154) (19,154)
--------------------------------------------------------------------------------------------------
Balance at December 31, 1997 9,164,848 1 54,702 (35,156) - (350) 19,197
Issuance of common stock
under stock option plan 15,539 - 48 48
Issuance of common stock
under employee stock
purchase plan (Note 11) 26,863 - 114 114
Compensation related to the
grant of common stock
options 54 (54) -
Amortization of deferred
compensation 354 354
Net loss (6,499) ( 6,499)
--------------------------------------------------------------------------------------------------
Balance at December 31, 1998 9,207,250 $1 $54,918 $(41,655) $ - $ (50) $ 13,214
==================================================================================================
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements.
24
<PAGE>
INNOVASIVE DEVICES, INC.
CONSOLIDATED STATEMENT OF CASH FLOWS
(In thousands, except share data)
<TABLE>
<CAPTION>
December 31,
------------------------------------
1998 1997 1996
--------- ---------- ---------
<S> <C> <C> <C>
Cash flows from operating activities
Net loss $(6,499) $(19,154) $ (4,062)
Adjustments to reconcile net loss to net cash
provided by (used for) operating activities:
Depreciation and amortization 989 571 273
Amortization of deferred compensation 354 120 -
Purchased in-process research and development - 13,370 -
Changes in assets and liabilities:
Accounts receivable (564) (854) (476)
Inventories (2,649) (1,853) (454)
Prepaid expenses (59) 7 (64)
Other assets 108 (1) (13)
Accounts payable (127) 37 169
Accounts payable to related party (332) 222 (95)
Accrued expenses 981 254 571
----------- --------- --------
Net cash used for operating activities (7,798) (7,281) (4,151)
Cash flows from investing activities
Purchases of fixed assets (1,117) (856) (596)
Purchases of marketable securities (7,624) (11,374) (9,861)
Redemption of marketable securities 17,185 10,631 -
Acquisition of business, net of cash acquired - (544) -
----------- --------- --------
Net cash provided by (used for) investing activities 8,444 (2,143) (10,457)
Cash flows from financing activities
Proceeds from issuance of preferred stock,
net of issuance costs - - 927
Proceeds from issuance of common stock,
net of issuance costs 162 117 21,454
Principal payments on note payable - (602) -
Net cash provided by (used for) financing activities 162 (485) 22,381
----------- --------- --------
Net increase (decrease) in cash and cash equivalents 808 (9,909) 7,773
Cash and cash equivalents at beginning of year 2,916 12,825 5,052
----------- --------- --------
Cash and cash equivalents at end of year $ 3,724 $ 2,916 $ 12,825
=========== ========= ========
</TABLE>
Supplemental disclosure of non-cash financing activities:
In June 1997, the Company acquired substantially all of the operating assets of
MedicineLodge, Inc. in exchange for 1,885,000 shares of the Company's common
stock and the assumption of certain liabilities. (Note 2)
The accompanying notes are an integral part of the consolidated financial
statements.
25
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS
(In thousands, except share data)
1. Nature of Business and Summary of Significant Accounting Policies
The Company designs, develops, manufactures and markets proprietary tissue
repair systems for use in the sports medicine/arthroscopy segment of the
orthopaedic market. The Company currently markets a broad-based product line
within five product platforms: suture fasteners, suturing systems, cartilage
repair products, ACL reconstruction systems and meniscal repair products.
As a result of funding an aggressive research and development effort, the
establishment of its manufacturing capabilities and the expansion of its
global sales and marketing organization, the Company has incurred losses
since inception and as of December 31, 1998 had an accumulated deficit of
$41.7 million. On December 31, 1998, the Company had cash and marketable
securities of $4.8 million and borrowing availability under a $2.5 million
working capital line of credit (Note 7).
The Company's ability to fund ongoing operating activities with existing
capital resources, its working capital line of credit and cashflow from
operations will be dependent upon the strengthening of its sales channels and
the extent to which its proucts gain market acceptance in order to increase
sales sufficiently to generate profits from operations.
Therefore, the Company cannot provide assurances that it will not require
additional financing in the future and that such funds would be available on
terms acceptable to the Company.
Revenue Recognition, Accounts Receivable and Concentration of Credit Risk
Revenue is recognized upon shipment of product. Ongoing credit evaluations
of customers' financial condition are performed and collateral is not
required. Concentration of credit risk with respect to accounts receivable
is limited due to the large number of customers comprising the Company's
customer base. The Company maintains reserves for potential credit losses
and such losses, in the aggregate, have not exceeded management's
expectations.
Principles of Consolidation
The consolidated financial statements reflect the operations of the Company
and its wholly-owned subsidiary. All significant intercompany balances and
transactions have been eliminated.
Cash, Cash Equivalents and Marketable Securities
The Company considers all highly liquid investments purchased with a maturity
of three months or less to be cash equivalents and those with maturities
greater than three months are considered to be marketable securities.
Marketable securities are stated at amortized cost plus accrued interest,
which approximates fair value. Cash equivalents and marketable securities
consist primarily of corporate debt securities, U.S. government agency
obligations and money market instruments.
The Company has classified its investments as "available-for-sale" as defined
under Statement of Financial Accounting Standards ("SFAS") No. 115,
"Accounting for Certain Investments in Debt and Equity Securities." and any
associated unrealized gains or losses, if material, are recorded as a
separate component of equity until realized. At December 31, 1998 and 1997,
any unrealized gains or losses were immaterial.
Inventories
Inventories are stated at the lower of cost or market, with cost being
determined using the first-in, first-out method.
Fixed Assets
Fixed assets are recorded at cost and depreciated using the straight-line
method over their estimated useful lives. Repair and maintenance costs are
expensed as incurred.
26
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS - (Continued)
(In thousands, except share data)
the carrying amount of such assets, an impairment loss is recognized for the
difference between estimated fair value and the carrying amount of the asset.
Goodwill
Goodwill represents the excess of cost over the fair value of net assets
acquired, and is being amortized on a straight-line basis over the estimated
useful life of ten years. Accumulated amortization totaled $193 and $77 at
December 31, 1998 and December 31, 1997, respectively.
Basic and diluted net loss per share
Net loss per share has been calculated in accordance with SFAS No. 128,
"Earnings per Share". SFAS No. 128 requires the presentation of basic
earnings per share and diluted earnings per share.
Basic earnings per share is computed by dividing the income available to
common stockholders by the weighted average number of common shares
outstanding for the period. For purposes of calculating diluted earnings per
share, the denominator includes both the weighted average number of common
shares outstanding and potential dilutive common shares outstanding for the
period.
For each of the years presented, basic and diluted earnings per share are
the same due to the antidilutive effect of potential common shares
outstanding. Antidilutive potential common shares excluded from the 1998,
1997 and 1996 computation include 1,656,299, 1,505,608 and 732,536 common
shares, respectively, issuable upon the exercise of stock options.
Stock-Based Compensation
Stock-based compensation awards to employees under the Company's stock plans
are accounted for using the intrinsic value method prescribed in Accounting
Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees"
and related interpretations. The Company has adopted the disclosure
requirements of SFAS No. 123, "Accounting for Stock-Based Compensation."
Accounting for the impairment of long-lived assets
The Company periodically evaluates its long-lived assets whenever events or
changes in circumstances indicate that the carrying amount of an asset may
not be recoverable. At the occurrence of such an event or change in
circumstances, the Company evaluates a potential impairment of an asset based
on estimated future undiscounted cash flows. In the event that future
undiscounted cash flows are less than
Use of Estimates
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of
contingencies at December 31, 1998 and 1997, and the reported amounts of
revenues and expenses during the three years in the period ended December 31,
1998. Actual results could differ from those estimates.
27
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS - (Continued)
(In thousands, except share data)
Concentration
Certain of the materials incorporated into the Company's products are
obtained from a single source or a limited group of suppliers. The Company
seeks to reduce the impact from it dependence on those sole and limited
source suppliers by considering alternative sources of supply and maintaining
an adequate supply of the materials. However, the loss of one or more of the
sole or limited suppliers could cause a delay in manufacturing and a
potential loss of sales, which could affect operating results adversely.
New Accounting Pronouncement
In June 1998, the FASB issued SFAS No. 133, "Accounting for Derivative
Instruments and Hedging Activities." This statement establishes new
standards for the recognition of gains and losses on derivative instruments
and provides guidance as to whether a derivative may be accounted for as a
hedging instrument. Gains or losses from hedging transactions may be wholly
or partially recorded in earnings or comprehensive income as part of a
cumulative translation adjustment, depending upon the classification of the
hedge transaction. Gain or loss on a derivative instrument not classified as
a hedging instrument is recognized in earnings in the period of change. SFAS
No. 133 will be effective for the Company in 2000. The Company does not
believe adoption of SFAS No. 133 will have a material impact on its financial
position or its results of operations.
2. Acquisition
On June 27, 1997, the Company, through a newly formed subsidiary, acquired
substantially all of the operating assets of MedicineLodge, Inc. ("MLI"), in
exchange for 1,885,000 shares of the Company's common stock valued at $14,326
and the assumption of certain liabilities. MLI designs, develops,
manufactures and is marketing proprietary surgical implants which facilitate
the repair of the Anterior Cruciate Ligament (ACL) of the knee. The
acquisition has been accounted for under the purchase method and,
accordingly, the purchase price has been allocated based on the estimated
fair value of assets purchased and liabilities assumed upon acquisition. A
portion of the purchase price relating to research projects which had not yet
reached technological feasibility and had no alternative future use, was
allocated to in-process research and development, resulting in a charge to
the Company's operations of $13,370. The excess of cost over the fair value
of net assets acquired (goodwill) of $1,403 is being amortized over 10 years
on a straight-line basis. The operating results of MLI are included in the
Company's results from the date of acquisition.
28
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS - (Continued)
(In thousands, except share data)
The following unaudited pro forma summary combines the results of operations
of the Company and MLI as if the acquisition had occurred at the beginning of
1997 and 1996, after giving effect to certain adjustments, including the
write-off of purchased in-process research and development and amortization
of goodwill. The unaudited pro forma summary does not necessarily reflect
the results of operations as they would have been if the Company and MLI had
constituted a single entity during such periods.
<TABLE>
<CAPTION>
Year ended
December 31,
----------------------------------------
1997 1996
---------------- ------------------
<S> <C> <C>
Net sales $ 8,298 $ 5,659
Net loss (20,080) (18,849)
Basic and diluted net loss per share $ (2.19) $ (1.74)
</TABLE>
3. Marketable Securities
The amortized cost of available-for-sale securities (including accrued
interest), which approximates fair value, consists of the following:
<TABLE>
<CAPTION>
December 31,
------------------------------------
1998 1997
--------------- ---------------
<S> <C> <C>
Corporate debt securities $ 2,842 $ 6,779
U.S. government agency obligations - 5,011
Money market instruments 1,925 1,694
------- -------
Total available for sale 4,767 13,484
Less cash equivalents (3,724) (2,880)
------- -------
Total marketable securities $ 1,043 $10,604
======= =======
</TABLE>
The amortized cost of the Company's investment in debt securities at December
31, 1998 was comprised of $2.8 million due in one year or less. Due to the
short-term nature of the investments, expected maturities and contractual
maturities are normally the same.
The Company did not realize any gains or losses on available-for-sale
securities during the three years ended December 31, 1998 as the securities
have been held to maturity.
4. Inventories
Inventories consist of the following:
<TABLE>
<CAPTION>
December 31,
----------------------------------
1998 1997
--------------- -------------
<S> <C> <C>
Raw materials $1,880 $1,360
Work-in-process 640 329
Finished goods 3,076 1,258
------- -------
$5,596 $2,947
======= =======
</TABLE>
29
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS - (Continued)
(In thousands, except share data)
Inventories are shown net of a reserve which has been established to provide
for estimated losses arising from inventory obsolescence. The Company
estimates its reserve requirement for obsolete inventory based upon such
factors as historical usage, projected sales and the impact of new product
introductions. Amounts charged to cost of sales relating to the obsolescence
reserve were approximately $606, $309, and $293 in 1998, 1997 and 1996,
respectively.
5. Fixed Assets
Fixed assets consist of the following:
<TABLE>
<CAPTION>
Useful life December 31,
in years ----------------------
1998 1997
--------- ----------
<S> <C> <C> <C>
Furniture and fixtures 3 - 7 $1,132 $1,042
Machinery and equipment 2 - 5 1,774 995
Leasehold improvements 3 159 141
Tooling 3 - 5 1,146 916
--------- ----------
4,211 3,094
Less - Accumulated depreciation
and amortization 1,999 1,134
--------- ----------
$2,212 $1,960
========= ==========
</TABLE>
Depreciation and amortization expense relating to fixed assets was $865, $522
and $273 for 1998, 1997 and 1996 respectively.
6. Accrued Expenses
Accrued expenses consist of the following:
<TABLE>
<CAPTION>
December 31,
----------------------------------
1998 1997
--------------- -------------
<S> <C> <C>
Employee compensation and benefits $ 795 $ 445
Commissions 239 250
Professional fees 269 164
Other 800 263
------- -------
$ 2,103 $ 1,122
======= =======
</TABLE>
7. Debt
In connection with the acquisition of MLI in June 1997 (Note 2), the Company
assumed a note payable in the amount of $602. The Company paid the note in
full in July 1997.
On December 31, 1998, the Company entered into a working capital line of
credit with a bank, that
30
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS - (Continued)
(In thousands, except share data)
provides the Company with a maximum borrowing availability of $2.5 million,
limited by certain receivable and inventory balances. Borrowings under this
agreement bear interest at the prime rate. The line of credit expires and all
outstanding amounts thereunder are due December 31, 1999. Under the line of
credit, the Company is obligated to comply with certain financial covenants.
There were no borrowings outstanding under the line of credit at December 31,
1998.
8. Income Taxes
The provision (benefit) for incomes taxes was as follows:
<TABLE>
<CAPTION>
December 31,
------------------------------------------
1998 1997 1996
-------- ------- -------
<S> <C> <C> <C>
Deferred tax benefit
Federal $(2,135) $(1,941) $(1,337)
State (609) (579) (383)
-------- -------- -------
Total deferred (2,744) (2,520) (1,720)
Tax asset valuation allowance 2,744 2,520 1,720
-------- -------- -------
$ - $ - $ -
======== ======== =======
</TABLE>
Deferred income taxes reflect the tax impact of temporary differences between
the amount of assets and liabilities for financial reporting purposes and
such amounts as measured by tax laws and regulations. Under SFAS No. 109, the
benefit associated with future deductible temporary differences is recognized
if it is more likely than not that a benefit will be realized. Based on
historical evidence of net losses, the Company has recorded a valuation
allowance that offsets all net deferred tax assets. Principal components of
the deferred tax assets and liabilities included on the balance sheet at
December 31, 1998 and 1997 were as follows:
<TABLE>
<CAPTION>
December 31,
---------------------------------------
1998 1997
------------------- ----------------
<S> <C> <C>
Deferred tax assets:
Net operating loss carryforwards $ 8,604 $ 6,217
Inventory 371 404
Research and development tax credit 621 407
Other items 444 268
--------- ---------
Gross deferred tax assets 10,040 7,296
Deferred tax asset valuation allowance (10,040) (7,296)
--------- ---------
$ - $ -
========= =========
</TABLE>
31
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS - (Continued)
(In thousands, except share data)
A reconciliation between the amount of reported tax benefit and the amount
computed using the U.S. Federal statutory rate of 35% for 1998, 1997 and 1996
follows:
<TABLE>
<CAPTION>
December 31,
-----------------------------------------------------------
1998 1997 1996
------------------- ------------------- -------------
<S> <C> <C> <C>
Tax benefit at statutory rate $ (2,275) $ (6,704) $ (1,422)
State tax, net of federal benefit (332) (307) (196)
In-process research and development
charge for the purchase of MLI - 4,680 -
Research and development credit (190) (209) (107)
Other 53 20 5
--------- --------- ---------
(2,744) (2,520) (1,720)
Increase in valuation allowance 2,744 2,520 1,720
--------- --------- ---------
$ - $ - $ -
========= ========== =========
</TABLE>
The Company has U.S. Federal net operating loss carryforwards of
approximately $21.1 million and tax credit carryforwards of approximately
$398. The operating loss and tax credit carryforwards expire in the
years 2009 through 2018.
An ownership change, as defined by Section 382 of the Internal Revenue Code,
resulting from the Company's initial public offering in June 1996, will limit
the utilization of net operating loss and tax credit carryforwards generated
prior to June 1996 to approximately $3.9 million per year. Subsequent
significant ownership changes could, however, further limit the utilization
of these carryforwards in future years.
9. Mandatorily Redeemable Convertible Preferred Stock
In February and March 1994, the Company issued 4,260,337 shares of Series A
mandatorily redeemable convertible preferred stock ("Series A Preferred
Stock") and 695,032 shares of common stock. Upon issuance of the preferred
stock and the common stock, the Company received net proceeds of $6 million
and converted notes payable in the amount of $2.5 million plus accrued
interest of $107.
In October 1995, the Company issued 3,271,000 shares of Series B mandatorily
redeemable convertible preferred stock ("Series B Preferred Stock"). Upon
issuance, the Company received net proceeds of $6 million and converted notes
payable in the amount of $1 million which was issued in August 1995 in the
form of a bridge loan.
In January 1996, the Company issued an additional 442,235 shares of Series B
Preferred Stock, resulting in net proceeds to the Company of $927.
All shares of Series A and Series B Preferred Stock converted into 3,543,819
shares of common stock at the conversion ratio of 2.25 shares of Preferred
Stock for each share of common stock upon the closing of the Company's
initial public offering in June 1996.
32
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS - (Continued)
(In thousands, except share data)
10. Stockholders' Equity
Reverse Common Stock Split
A 1-for-2.25 reverse stock split of the Company's common stock became
effective on May 7,1996. All shares of common stock, options and per share
amounts included in the accompanying financial statements have been adjusted
to give retroactive effect to the reverse stock split for all years
presented.
Initial Public Offering
In June 1996, the Company completed an initial public offering of 1,900,000
shares of its common stock. The net proceeds to the Company were
approximately $21.5 million.
Preferred Stock
On April 3, 1996, the stockholders of the Company authorized 1,000,000
shares of $0.01 par value preferred stock. Preferred stock may be issued at
the discretion of the Board of Directors of the Company (without stockholder
approval) with such designations, rights and preferences as the Board of
Directors may determine from time to time. The preferred stock may have
dividend, liquidation, redemption, conversion, voting or other rights which
may be more expansive than the rights of the holders of common stock.
On January 12, 1999, the director's of the Company voted to designate
25,000 shares of the Company's Preferred Stock as Series A Junior Preferred
Stock and reserved those shares for issuance on the exercise of Rights
granted under the Company's Shareholder Rights Plan.
Treasury Stock
Common stock held in treasury at December 31, 1995 represents the Company's
repurchase of common stock at cost. These shares were reissued in
conjunction with the Company's initial public offering in June 1996.
Shareholder Rights Plan
In January 1999, the Company's Board of Directors adopted a Shareholders
Rights Plan. This Plan provides shareholders with special purchase rights
under certain circumstances, including if any new person or group acquires
15% percent or more of the Company's outstanding common stock.
11. Stock Plan
The Company maintains three stock plans which provide for the granting of
incentive stock options, non-qualified stock options and restricted stock to
employees, directors and certain other individuals.
The 1992 Stock Option Plan (the "1992 Plan") provides for the issuance of a
maximum of 692,869 shares of common stock pursuant to the grant of incentive
and non-qualified stock options.
33
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS - (Continued)
(In thousands, except share data)
Incentive stock options may be granted to any officer or employee at an
exercise price per share of not less than the fair market value per common
share on the date of such grant (not less than 10% of such value in the case
of holders of 10% or more of the total combined voting power of all classes
of the Company's stock). Non-qualified options may be granted to any
employee, officer, director or consultant at an exercise price per share to
be specified by the Board of Directors on the date of grant. Options granted
under the 1992 Plan are exercisable over periods determined by the Board of
Directors, not to exceed ten years from the date of grant. The Company does
not intend to issue any additional options under the 1992 Plan, however
options that are forfeited will become available for grant under the 1996
Omnibus Stock Plan (the "Omnibus Plan").
Under the terms of the Omnibus Plan, employees, directors and certain other
individuals may be awarded incentive stock options, nonqualified stock
options or restricted stock. The Omnibus Plan provides for the issuance of a
maximum of 800,000 shares of common stock, plus such additional number of
shares that become available due to the forfeiture of options granted under
the 1992 Plan. The term of each option cannot exceed ten years (five years
for options granted to holders of 10% or more of the total voting power of
all classes of the Company's stock). Incentive stock options must be granted
at an exercise price equal to the fair market value of the stock on the date
of grant and vest over a period not to exceed 10 years.
The 1996 Non-Employee Director Stock Option Plan (the "Director Plan")
provides for the grant of options for the purchase of up to 150,000 shares of
common stock of the Company. Under the terms of the Director Plan, each non-
employee director will receive an option to purchase 2,500 shares of common
stock at each annual meeting of stockholders. In addition, each new non-
employee director will receive upon his or her initial election an option to
purchase 10,000 shares of common stock. The term of each option cannot
exceed ten years. All options granted under the Directors plan will be at an
exercise price equal to the fair market value of the stock on the date of
grant and will vest evenly over a four-year period.
Stock option activity is summarized as follows:
<TABLE>
<CAPTION>
Weighted
Number of Average
Shares Exercise Price
------------------- -------------------
<S> <C> <C>
Outstanding at December 31, 1995 478,878 $ 1.78
Granted 262,324 7.34
Forfeited (3,555) 2.47
Exercised (5,111) 1.69
-------------------
Outstanding at December 31, 1996 732,536 3.77
Granted 807,100 10.35
Forfeited (24,628) 8.18
Exercised (9,940) 3.55
-------------------
Outstanding at December 31, 1997 1,505,068 7.23
Granted 978,444 4.87
Forfeited (811,674) 9.41
Exercised (15,539) 3.07
-------------------
Outstanding at December 31, 1998 1,656,299 $ 4.72
===================
</TABLE>
34
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS - (Continued)
(In thousands, except share data)
The number and weighted average exercise price of options exercisable at
December 31, 1998, 1997 and 1996 is 676,850 and $4.69; 421,738 and $2.58 and
284,222 and $1.81, respectively.
The following table summarizes information about stock options outstanding
and exercisable at December 31, 1998.
<TABLE>
<CAPTION>
Options Outstanding Options Exercisable
------------------------------------------------------------------- --------------------------------------------
Weighted Average
Range of Number Remaining Weighted Average Number Weighted Average
Exercise Price Outstanding Contractual Life Exercise Price Exercisable Exercise Price
<S> <C> <C> <C> <C> <C>
1.69 438,893 5.33 1.69 430,824 1.69
3.25 - 3.31 699,444 9.89 3.25 - -
5.00 - 5.63 23,998 7.85 5.21 7,998 5.63
6.75 158,327 7.14 6.75 70,766 6.75
9.25 - 9.50 104,550 9.39 9.38 1,675 9.46
10.00 - 10.87 74,050 7.77 10.08 39,300 10.06
12.00 157,037 8.49 12.00 126,287 12.00
-------------- --------------
Total 1,656,299 676,850
============== ==============
</TABLE>
An aggregate of 50,000 shares of common stock is reserved for issuance
pursuant to the 1996 Employee Stock Purchase Plan (the "Stock Purchase
Plan"). Employees whose customary employment is in excess of 20 hours per
week and five months per year and who own less than 5% of stock in the
Company are eligible to participate in the plan. Employees participating in
the plan will have the opportunity to purchase common stock at a price equal
to the lesser of 85% of the fair market value on the date the right was
granted or 85% of the fair market value on the date the right was exercised.
The Company issued 26,863 and 9,500 shares to employees participating in the
plan in 1998 and 1997, respectively.
Compensation cost based upon the fair value approach as prescribed under SFAS
No. 123 has not been recognized for stock options granted to employees as the
Company adopted the disclosure-only provisions of SFAS No. 123. Had
compensation for the Company's stock plans been determined based on the fair
value at the grant date for awards in 1998, 1997 and 1996 consistent with the
provisions of SFAS No. 123, the Company's net loss and net loss per share
would have been as follows:
<TABLE>
<CAPTION>
Year ended December 31,
------------------------------------------------------------
1998 1997 1996
------------------- ------------------- ---------------
<S> <C> <C> <C>
Net Loss:
As reported $ (6,499) $(19,154) $(4,062)
Pro forma (7,211) (19,682) (4,168)
Basic and diluted net loss per share
As reported $ (0.71) $ (2.33) $ (0.83)
Pro forma (0.79) (2.39) (0.85)
</TABLE>
35
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS - (Continued)
(In thousands, except share data)
The fair value of each option grant was estimated on the grant date using
the Black-Scholes option-pricing model with the following weighted average
assumptions for 1998, 1997 and 1996: expected option term of five years;
dividend yield of 0%; risk free interest rate of 4.5 to 5.3%, 5.7% and 6.2%
in 1998, 1997 and 1996, respectively; and expected volatility of 0% for
options granted prior to the initial filing of the Company's registration
statement in April 1996, 55% for options granted from April 1996 to December
1996 and 44%-55% for options granted from January 1997 through December
1998. The weighted average fair value per option for options granted in
1998, 1997 and 1996 was $2.25, $4.86 and $2.46, respectively.
Because options vest over several years and additional option grants are
expected to be made in subsequent years, the pro forma impact on 1998, 1997
and 1996 is not representative of the pro forma effects of reported net
income (loss) and net income (loss) per share for future years.
During 1997, the Company granted options in the amount of 154,000 shares to
nonemployees under the Omnibus Plan. The estimated fair value of these
options totaled $470, was recorded as deferred compensation and is being
amortized over the vesting period of the options. In November 1997, the
Emerging Issues Task Force of the Financial Accounting Standards Board
finalized Issue No. 96-18 "Accounting for Equity Instruments That Are Issued
to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods
or Services" ("EITF 96-18"). Under EITF 96-18, the compensation expense that
will ultimately be recognized for certain of the options issued to
nonemployees in 1997 will be measured at the vesting date of the underlying
options. The Company has recorded deferred compensation at a preliminary
value of $341 for 131,500 of these options which have not vested as of
December 31, 1997. As these options vest over periods of one to four years,
the Company will be required to remeasure the fair value of these options at
each reporting period prior to vesting and then finally at the vesting date
of the options. Changes in the estimated fair value of these options will be
recognized as compensation expense in the period of the change. During 1998,
the Company accelerated vesting on 115,000 of these options resulting in a
final compensation charge of $214.
Repricing
The Company elected to grant employees with outstanding stock options the
opportunity to cancel their existing options and receive new options on a
one for one basis with a new four-year vesting schedule commencing on the
new date of grant. On December 14, 1998, 684,444 outstanding common stock
options were canceled and 684,444 new options were granted with an exercise
price of $3.25 per share, the fair market value of the Company's common
stock on December 14, 1998. The cancellation and issuance of new options is
included in the option activity above.
12. Retirement Savings Plan
The Company provides an employee retirement savings plan under Section
401(k) of the Internal Revenue Code (the "Plan") which covers substantially
all employees. Under the terms of the Plan, employees may contribute a
percentage of their salary, up to a maximum of 15%, which is then invested
in one or more of several mutual funds selected by the employee. The Company
may make contributions to the Plan at its discretion; no contributions have
been made since inception of the Plan.
36
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS - (Continued)
(In thousands, except share data)
13. Segment Reporting
Effective January 1, 1998, the Company adopted SFAS No. 131, Disclosures
about Segments of an Enterprise and Related Information. SFAS No. 131
superseded SFAS No. 14, Financial Reporting for Segments of a Business
Enterprise. SFAS No. 131 establishes standards for reporting information
about operating segments, products and services, geographic areas, and major
customers. The adoption of SFAS No. 131 did not affect the Company's results
of operations or financial position. The Company operates in one reportable
segment under SFAS No. 131.
For 1996, sales approximating 13% of total sales were attributable to one
customer. No customer accounted for greater than 10% of net sales for 1998
or 1997.
Export sales were 17% (10% to Europe, 3% to Japan and 4% to other regions),
15% (7% to Japan, 7% to Europe and 1% to other regions), and 27% (13% to
Japan, 10% to Europe and 4% to other regions) of total sales for 1998, 1997
and 1996, respectively.
14. Commitments
Related Party Transaction
In October 1995, the Company entered into Research & Development,
Distribution and Supply agreements (the "Agreements") with Collagen
Corporation. In October 1997, Collagen announced that it would proceed to
separate its Aesthetic Technologies Group and its Collagen Technologies
Group ("CTG") into two independent, publicly-traded companies. Cohesion
Technologies, Inc. ("Cohesion") was organized as a Delaware corporation and
wholly owned subsidiary of Collagen in June 1997. Effective January 1, 1998,
Collagen contributed certain research and development programs of CTG to
Cohesion including its development program with Innovasive Devices, Inc.
Collagen also contributed various equity investments to Cohesion including
all of its holdings in Innovasive Devices, Inc. In connection with the
separation, Collagen distributed as a dividend to its stockholders on August
18,1998, one share of Cohesion Common Stock for each share of Collagen
common stock outstanding. As a result of this transaction, Cohesion
Technologies beneficially owned 843,936 shares, or approximately 9.2% of the
Company's Common Stock. Cohesion also assumed Collagen's relationship and
obligations with the Company.
Pursuant to the Agreements, the Company will fund up to $1.7 million of
research and development efforts performed by Cohesion Technologies to
develop certain products. In consideration for the funding provided, the
Company will receive certain rights to market, sell and distribute certain
products, subject to satisfying certain minimum sales requirements,
resulting from such research and development efforts. Total research and
development expense incurred under the Agreements was $60, $428, and $664
for 1998, 1997 and 1996, respectively.
37
<PAGE>
INNOVASIVE DEVICES, INC.
NOTES TO FINANCIAL STATEMENTS - (Continued)
(In thousands, except share data)
Facility Lease
The Company leases office and manufacturing facilities under various non-
cancelable operating leases ranging from one to five years. Future minimum
lease commitments are approximately as follows:
<TABLE>
<S> <C>
1999 $271
2000 250
2001 221
2002 92
2003 -
-----
$834
=====
</TABLE>
Total rent expense under non-cancelable facility leases was approximately
$264, $181 and $172 for 1998, 1997 and 1996, respectively.
38
<PAGE>
Item 9. Changes in and Disagreements with Accountants
on Accounting and Financial Disclosure
Not Applicable
39
<PAGE>
Part III
Item 10. Directors and Executive Officers of the Registrant
Information with respect to Directors may be found under the caption
"Election of Directors" appearing in the Company's definitive Proxy
Statement for the 1999 Annual Meeting of Stockholders. Such
information is incorporated herein by reference.
Item 11. Executive Compensation
The information set forth under the captions "Executive Officer
Compensation" and "Director Compensation" appearing in the Company's
definitive Proxy Statement for the 1999 Annual Meeting of Stockholders
is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management
The information set forth under the captions "Principal Stockholders"
and "Stock Ownership of Directors and Executive Officers" appearing in
the Company's definitive Proxy Statement for the 1999 Annual Meeting
of Stockholders is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions
Related Party Transaction
In October 1995, the Company entered into Research & Development,
Distribution and Supply agreements (the "Agreements") with Collagen
Corporation. In October 1997, Collagen announced that it would proceed
to separate its Aesthetic Technologies Group and its Collagen
Technologies Group ("CTG") into two independent, publicly traded
companies. Cohesion Technologies, Inc. ("Cohesion") was organized as a
Delaware corporation and wholly owned subsidiary of Collagen in June
1997. Effective January 1, 1998, Collagen contributed certain research
and development programs of CTG to Cohesion including its development
program with Innovasive Devices, Inc. Collagen also contributed
various equity investments to Cohesion including all of its holdings
in Innovasive Devices, Inc. In connection with the separation,
Collagen distributed as a dividend to its stockholders on August
18,1998, one share of Cohesion common stock for each share of Collagen
common stock outstanding. As a result of this transaction, Cohesion
Technologies beneficially owned 843,936 shares, or approximately 9.2%
of the common stock of Innovasive Devices, Inc. at December 31, 1998.
At December 31, 1998, the Company had expended approximately
$1,416,000 pursuant to the Agreements. Cohesion Technologies has the
right to designate one member of the Company's Board of Directors so
long as it holds at least five percent of the Company's outstanding
Common Stock on a fully-diluted basis. Mr. David Foster, Chief
Executive Officer of Cohesion Technologies, currently serves as
Cohesion Technologies Corporation's designee on the Company's Board of
Directors.
40
<PAGE>
Part IV
ITEM 14. Exhibits, Financial Statements, Schedules, and Reports on Form 8-K
(a) The following documents are filed as a part of this report:
(1) Financial Statements - See Index to Financial Statements at
Item 8 of this report.
(2) Financial Statement Schedules
(3) Exhibits
41
<PAGE>
ITEM 14. (a) (2) Financial Statement Schedules
Schedule II
Valuation and Qualifying Accounts and Reserves for the Three Years Ended
December 31, 1998
<TABLE>
<CAPTION>
Balance at Charged to Charged Deductions Balance
(In thousands) beginning Costs and to other and at end of
of period expenses accounts write-offs period
<S> <C> <C> <C> <C> <C>
Allowance for doubtful accounts
- -----------------------------------------
December 31, 1996 50 52 - (13) 89
December 31, 1997 89 36 - (4) 121
December 31, 1998 121 36 - (17) 140
Inventory obsolescence reserve
- -----------------------------------------
December 31, 1996 389 293 - (60) 622
December 31, 1997 622 309 - (330) 601
December 31, 1998 601 606 - (157) 1,050
Deferred tax assets valuation
allowance
- -----------------------------------------
December 31, 1996 3,056 - 1,720 - 4,776
December 31, 1997 4,776 - 2,520 - 7,296
December 31, 1998 7,296 - 2,744 - 10,040
</TABLE>
42
<PAGE>
ITEM 14. (a) (3) Exhibits
INNOVASIVE DEVICES, INC.
EXHIBIT INDEX
Exhibit
10.1 Employment Agreement, dated June 27, 1997, between Registrant and
Alan Chervitz Incorporated by reference to the Company's Form 10-Q for
the Quarter ended June 30, 1997.
10.2 Employment Agreement, dated June 27, 1997, between Registrant
and T. Wade Fallin Incorporated by reference to the Company's Form
10-Q for the Quarter ended June 30, 1997.
10.3 Consulting Agreement dated June 27, 1997, between Registrant
and Richard B. Caspari, M.D. Incorporated by reference to the
Company's Form 10-Q for the Quarter ended June 30, 1997.
23 Consent of PricewaterhouseCoopers LLP, Independent Accountants
23.1 Consent of PricewaterhouseCoopers LLP, Independent Accountants
27 Financial Data Schedule
99 Cautionary statement for purposes of the "Safe Harbor" provisions of
the Private Securites Litigation Reform Act of 1995.
43
<PAGE>
Exhibit 23
CONSENT OF INDEPENDENT ACCOUNTANTS
We hereby consent to the incorporation by reference in the Registration
Statement on Form S-8 (No. 333-11815) of Innovasive Devices, Inc. of our report
dated February 18, 1999 appearing on page 21 of this Form 10-K.
PricewaterhouseCoopers LLP
Boston, Massachusetts
March 31, 1999
<PAGE>
Exhibit 23.1
CONSENT OF INDEPENDENT ACCOUNTANTS
We hereby consent to the incorporation by reference in the Prospectus
constituting part of the Registration Statement on Form S-3 (No. 333-32523) of
Innovasive Devices, Inc. of our report dated February 18, 1999 appearing on page
21 of this from 10-K.
PricewaterhouseCoopers LLP
Boston, Massachusetts
March 31, 1999
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE BALANCE
SHEET AT DECEMBER 31, 1998 AND THE STATEMETN OF OPERATIONS FOR THE YEAR ENDED
DECEMBER 31, 1998 AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH
FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
<S> <C>
<PERIOD-TYPE> YEAR
<FISCAL-YEAR-END> DEC-31-1998
<PERIOD-START> JAN-01-1998
<PERIOD-END> DEC-31-1998
<CASH> 3,724
<SECURITIES> 1,043
<RECEIVABLES> 2,329
<ALLOWANCES> 140
<INVENTORY> 5,596
<CURRENT-ASSETS> 12,727
<PP&E> 3,094
<DEPRECIATION> 1,999
<TOTAL-ASSETS> 16,059
<CURRENT-LIABILITIES> 2,845
<BONDS> 0
0
0
<COMMON> 1
<OTHER-SE> 13,213
<TOTAL-LIABILITY-AND-EQUITY> 16,059
<SALES> 11,911
<TOTAL-REVENUES> 11,911
<CGS> 3,339
<TOTAL-COSTS> 3,339
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (6,499)
<INCOME-TAX> 0
<INCOME-CONTINUING> (6,499)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (6,499)
<EPS-PRIMARY> (0.71)
<EPS-DILUTED> (0.71)
</TABLE>
<PAGE>
Exhibit 99
CAUTIONARY STATEMENT FOR PURPOSES OF THE
"SAFE HARBOR" PROVISIONS OF THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
Innovasive Devices, Inc. (the "Company") desires to take advantage of the "safe
harbor" provisions of the Private Securities Litigation Reform Act of 1995 (the
"Act"). Except for the Conference Report, no official interpretations of the
Act's provisions have been published. All of the following important factors
discussed below have been discussed in the Company's Registration on Form S-1,
File No. 333-3368 under the Securities Act of 1933, which was declared effective
by the Securities Exchange Commission (the "Commission") on June 5, 1996.
Forward Looking Statements; Cautionary Statement. When used anywhere in future
filings by the Company with the Securities and Exchange Commission, in the
Company's press releases and in oral statements made with the approval of an
authorized executive officer of the Company, the words or phrases "will likely
result", "are expected to", "will continue", "is anticipated", "project", or
"outlook" or similar expressions (including confirmations by an authorized
executive officer of the Company of any such expressions made by a third party
with respect to the Company) are intended to identify "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995. The Company wishes to caution readers not to place undue reliance on
any such forward-looking statements, which speak only as of the date made. Such
statements are subject to certain risks and uncertainties that could cause
actual results to differ materially from historical earnings and those presently
anticipated or projected. These risk factors are described below. The Company
specifically declines any obligation to publicly release the result of any
revisions which may be made to any forward-looking statements to reflect
anticipated or unanticipated events or circumstances occurring after the date of
such statements.
The Company wishes to caution readers that the following important factors,
among others, in some cases have affected, and in the future could affect, the
Company's actual results and could cause the Company's actual consolidated
results for the Company's current quarter and beyond, to differ materially from
those expressed in any forward-looking statements made by, or on behalf of, the
Company:
History of Losses; Probability of Substantial Additional Future Losses;
Uncertainty of Future Results; Seasonality of Sales. The Company has incurred
substantial operating losses since its inception and, as of December 31, 1998,
had an accumulated deficit of $41.7 million. These losses have resulted
principally from expenses associated with research and development efforts,
expenses associated with obtaining United States Food and Drug Administration
("FDA") clearance and the establishment of the Company's sales and marketing
organization. The Company expects to generate additional losses as it continues
to expend substantial resources in research and product development, funding of
clinical trials in support of obtaining necessary regulatory clearances or
approvals and expanding its manufacturing capabilities and marketing and sales
activities. Results of operations may fluctuate significantly from quarter to
quarter due to the timing of such expenditures, absence of a backlog of orders,
timing of the receipt of orders, promotional discounts of the Company's
products, timing of regulatory actions, introduction of new products by
competitors of the Company, pricing of competitive products and the cost and
effect of promotional and marketing programs. In addition, the Company
anticipates some seasonality due to the fact that generally fewer surgical
procedures are performed during the third quarter. The seasonal pattern may
cause fluctuations in the Company's results of operations. It is difficult to
predict the impact that this seasonality will have on the Company's results of
operations because of its limited operating history. The Company's revenue and
profitability will be critically dependent on expanding applications for its
current product lines both within arthroscopy and in other clinical specialties.
In addition, the Company's profitability could be adversely affected if it is
required to sell its products at reduced prices. There can be no assurance that
significant revenues or profitability will ever be achieved.
<PAGE>
Potential Volatility of Stock Price. The stock market has from time to time
experienced significant price and volume fluctuations that are unrelated to the
operating performance of particular companies. These broad market fluctuations
may adversely affect the market price of the Company's Common Stock. In
addition, the market price of the shares of Common Stock is likely to be highly
volatile. Factors such as fluctuations in the Company's operating results,
announcements of technological innovations or new products by the Company or its
competitors, FDA and international regulatory actions, actions with respect to
reimbursement matters, developments with respect to patents or proprietary
rights, mergers or acquisitions involving competitors, public concern as to the
safety of products developed by the Company or others, changes in health care
policy in the United States and internationally, changes in stock market analyst
recommendations regarding the Company, other medical device companies or the
medical device industry generally and general market conditions may have a
significant effect on the market price of the Common Stock.
Uncertainty of Market Acceptance. The Company's future prospects depend
significantly on increasing penetration of existing markets, acceptance of the
Company's products in new markets, and the development of new products for its
existing and future markets. There can be no assurance that any of the
Company's existing or future products will gain market acceptance among
physicians, patients or healthcare payors, even if reimbursement and necessary
regulatory approvals are obtained. To date, the Company's marketing efforts
have been directed primarily to the sports medicine segment of the orthopedic
market for tissue-to-bone fixation applications. The Company has no experience
in establishing marketing or distribution channels in other clinical areas.
With respect to its current products, the Company was not the first to market
devices for the attachment of soft tissue to bone and therefore, to succeed must
both take market share away from its existing competitors and create new demand
for its products. The size of the market for the Company's products will depend
in part on the Company's ability to persuade physicians that its products offer
clinical and other advantages over existing means of attaching soft tissue
structures to tissue or bone and that its fixation devices could be used for a
wider variety of clinical applications, such as repair of ligament or tendon
damage in the fingers or toes. In addition, the Company will need to
demonstrate that its products are cost-effective and convenient to use and that
the techniques for their use are relatively straightforward and simple. There
can be no assurance that the market for the Company's products will continue to
grow or that they will be accepted for orthopedic procedures not currently using
fixation devices and in markets outside of the sports medicine segment of the
orthopedic market.
Limited Product Line. A substantial portion of the Company's sales to date
have derived from the Company's suture fasteners and related instruments. The
Company now markets a broader line of products within five product platforms:
suture fasteners, suture systems, cartilage repair products, anterior cruciate
ligament ("ACL") reconstruction products and meniscal repair products. The
Company's clinical experience has been primarily in open surgery shoulder
procedures. The Company's future prospects depend in part on its ability to
broaden its clinical expertise to include arthroscopic procedures in the
shoulder and knee. The Company must also develop and train its distribution
channels to market and sell the expanded product offerings. For the fiscal
years ended December 31, 1998 and 1997, shoulder related products accounted for
approximately 67% and 75%, respectively, of the Company's sales. If the Company
is unable to maintain and gain market acceptance for each of its product
platforms there would be a material adverse effect on the Company's business,
financial condition and results of operations.
Rapid Technological Change and New Product Innovation. The medical device
market is subject to rapid technological change and new product introductions
and enhancements. The Company's ability to remain competitive in this market
will depend in significant part on its ability to develop and introduce new
products and enhancements on a timely and cost effective basis. The ability of
the Company to develop new and enhanced tissue fixation devices depends on a
number of factors, including product selection, timely and efficient completion
of product design, development of new materials and manufacturing processes,
timely
<PAGE>
regulatory approval, implementation of manufacturing and assembly processes and
effective sales and marketing and there is no assurance that the Company will be
successful in developing such products. If the Company experiences quality or
reliability problems with new products, reductions in orders, higher
manufacturing costs and additional warranty expenses may result. Because new
product development commitments must be made well in advance of sales, new
product decisions must anticipate both future demand and the availability of
technology to satisfy that demand. In the meantime, competitors may achieve
technological advances which provide a competitive advantage over the Company's
products. In addition, advances or developments in other fixation technologies,
including those relating to bioabsorbable materials or biomaterials, could
render the Company's products obsolete or less desirable. There can be no
assurance that the Company will successfully develop and introduce new products
and enhancements or that such products will achieve market acceptance.
Reliance on Patents and Proprietary Technology. The Company relies on
proprietary technology which it seeks to protect primarily through patents,
trade secrets and proprietary know-how. The Company currently holds thirty
three patents and twenty two United States and foreign patent applications
pending which cover certain aspects of its technology. With respect to the
patent applications, however, the breadth of the claims that will be covered by
the issued patents cannot be known until they are issued. Moreover, the degree
of protection against competing devices afforded by the Company's patents is
subject to uncertainties. There can be no assurance that others will not be
successful in challenging, invalidating or circumventing the Company's patents
or that the Company's patents and intellectual property rights will confer a
competitive advantage on the Company. In addition, there can be no assurance
that the Company will be able to obtain patents on future products, or that the
Company's products will not infringe the patents and proprietary rights of third
parties. The medical device industry has been characterized by extensive
litigation involving patents and other intellectual property rights, and certain
companies in the medical device industry have employed intellectual property
litigation to gain a competitive advantage. The Company may not be able to
successfully defend against a claimed infringement and there can be no assurance
that the Company will not become subject to patent infringement claims or
litigation or interference proceedings. Litigation may be necessary to enforce
patents issued to the Company or to protect its trade secrets and other
intellectual property rights. Any litigation or interference proceedings will
result in substantial expense to the Company and a significant diversion of
effort by its employees, and, if adversely determined to the Company, could
result in significant liabilities to third parties and limitations on the
manufacture, distribution or sale of the Company's products or on the use of
certain technologies in the Company's products.
Future Capital Needs; Uncertainty of Additional Funding. There can be no
assurance that additional equity or debt financing will not be required prior to
the time, if ever, the Company achieves and sustains profitability. The Company
may require additional financing to fund its operations. The Company's future
capital requirements will depend on many factors, including the progress of the
Company's research and development, the scope and results of preclinical studies
and clinical trials, the cost, timing and outcome of regulatory reviews, the
rate of technological advances, the market acceptance of any of the Company's
products, administrative and legal expenses, competitive products, and
manufacturing and marketing arrangements. Any additional equity financing may
result in dilution to the Company's stockholders. There can be no assurance
that funds will be available on favorable terms, if at all. If adequate funds
are not available, the Company may be required to cut back or discontinue one or
more of its product development programs, or obtain funds through strategic
alliances that may require the Company to relinquish rights to certain of its
technologies or products.
Regulatory Risks. The manufacturing, labeling, distribution and marketing of
the Company's products are subject to extensive and rigorous governmental
regulation in the United States and certain other countries where the process of
obtaining and maintaining required regulatory approvals is lengthy, expensive
and uncertain. In order initially to market its products for clinical use in
the United States, the Company must obtain clearance from the FDA either through
a procedure known as 510(k) pre-market notification or must receive approval by
a lengthier and more difficult procedure known as pre-market approval ("PMA").
Although
<PAGE>
all of the Company's current products have been cleared using the 510 (k)
procedure, there can be no assurance that the Company's future products or
modifications to the Company's existing products will be cleared by the FDA
using the 510(k) process rather than the more arduous and lengthy procedures
required for a PMA application, which may include extensive clinical studies,
manufacturing information and review by a panel of experts outside the FDA. For
example, to the Company's knowledge, the closest predicate device for a
collagen-based fastener required PMA approval. If the FDA were to require the
Company to obtain pre-market approval for the sale of its future products using
the PMA process, the time from development to marketing of those products could
be significantly extended, with a concomitant negative impact on the Company's
financial performance. The Company may market its products only for indications
that have been cleared by the FDA. The Company has no control over the use of
its devices by physicians. There can be no assurance that the Company will not
become subject to FDA actions resulting from physician use of its products for
non-approved indications. FDA regulations for the commercial sale of products is
subject to interpretation. Failure to comply with FDA requirements could result
in the FDA's refusal to accept clinical data from the Company or the imposition
of regulatory sanctions. In addition, there can be no assurance that the FDA
will not place significant limitations upon the intended use of the Company's
products as a condition to 510(k) clearance or PMA approval. Failure to receive,
or delays in receipt of, FDA clearances or approvals, including the need for
clinical trials or additional data as a prerequisite to clearance or approval,
or any FDA limitations on the intended use of the Company's products, could have
a material adverse effect on the Company's business, financial condition and
results of operations.
The Company has not obtained regulatory approval in all foreign countries for
all products which it plans to sell product. Starting in mid-1998, the Company
was required to obtain "CE" mark certification, which is an international symbol
of quality and compliance with applicable European medical device directives, in
order for it to sell its products in Europe. There can be no assurance that the
Company will be able to obtain the proper certification or regulatory approval
for all products in the foreign countries for which the Company desires to sell
its products. If the Company obtains regulatory approval to sell its products
in foreign countries, it would rely on independent distributors to comply with
certain of the foreign regulatory requirements. The inability or failure of the
Company to obtain proper certification and regulatory approval or the failure of
its independent distributors to comply with applicable regulatory requirements
could materially and adversely affect the Company's business, financial
condition and results of operations.
The Company and its contract manufacturers will be required to adhere to "Good
Manufacturing Practices" of the FDA and similar requirements in other countries,
which include testing, control and documentation requirements. Ongoing
compliance with good manufacturing practices ("GMP") and other applicable
regulatory requirements will be monitored through periodic inspections by state
and federal agencies, including the FDA, and by comparable foreign agencies.
Failure to comply with applicable regulatory requirements could result in, among
other things, warning letters, fines, injunctions, civil penalties, recall or
seizure of products, total or partial suspension of production, refusal of the
government to grant clearance or approval to the marketing of devices,
withdrawals of approvals and criminal prosecution. The restriction, suspension
or revocation of regulatory approvals or any other failure to comply with
regulatory requirements could have a material adverse effect on the Company.
Limited Manufacturing Experience. The Company manufactures and assembles its
suture fastener, suture systems, COR systems, ACL repair products and meniscal
repair products, but has yet to manufacture the volumes necessary for the
Company to achieve profitability. The Company intends to expand its
manufacturing capabilities to include bioabsorbable products and biomaterials,
and if the Company encounters difficulties in scaling up production of new
products, including problems involving production yields, quality control and
assurance, component supply and shortages of qualified personnel, such problems
could have a material adverse effect on the Company's business, financial
condition and results of operations.
Reliance on Sole or Limited Sources of Supply. Certain of the Company's
products are manufactured from molded polymers. The Company owns only one set
of molds for each of its products requiring a molding
<PAGE>
manufacturing process. In the event that the molds are damaged, approximately 12
to 16 weeks would be required for the manufacture of new molds. Should the
Company's manufacturing process be disrupted, there can be no assurance that the
Company would be able to meet its commitments to customers. The failure of the
Company to meet its commitments could have a material adverse effect on the
Company's business, financial condition and results of operations.
In addition, certain suppliers may terminate sales of certain materials to
companies that manufacture medical devices in an attempt to limit their
potential product liability exposure. If the polymers which are used to
manufacture certain of the Company's products became unavailable, the Company
would be required to identify a new polymer material for those products and
certify the quality and suitability of the new material. In additional, a new
510(k) clearance would have to be obtained to market products manufactured from
the new materials. This process could take a substantial period of time and
there is no assurance that the Company would be able to identify, certify or
obtain clearance for the new polymer-based fasteners. The Company is attempting
to develop new tissue fixation devices from bioabsorbable materials and
biomaterials, particularly collagen. The Company believes that there are only a
few sources of bioabsorbable materials with the ability and expertise to
manufacture bioabsorbable materials for the Company's products. The Company
believes that even fewer sources of supply for collagen materials currently
exist. The Company has entered into a research and development and a
manufacturing and supply agreement with Collagen Corporation in connection with
a program to develop tissue fixation devices from collagen, but there are
provisions in those agreements that would enable either party to terminate the
arrangements in certain circumstances. If the Company were unable to obtain
sources of bioabsorbable materials or biomaterials to produce the next
generation of its products, the Company's future prospects and opportunities
would be substantially reduced, resulting in a material adverse effect on its
business, financial condition and results of operations.
Reliance on International Distributors. The Company depends primarily on outside
independent sales representatives and distributors for its international sales.
None of the Company's foreign representatives are subject to any long-term
commitments to the Company, and all of them represent a number of manufacturers
and sell a broad range of products in addition to those offered by the Company.
The revenues that such representatives are likely to receive from the promotion
and sale of other products may be substantially greater than the compensation
they may receive from the sale of the Company's products, and it may be
difficult for the Company to provide incentives to such representatives in order
to cause them to devote substantial attention to marketing and selling the
Company's products. International sales accounted for 17% of the Company's
revenues in 1998. The failure of the Company's foreign independent
representatives to generate substantial sales for the Company could have a
material adverse effect on the Company's business, financial condition and
results of operations. The loss of such sales representatives or distributors
or the inability of the Company to develop and maintain an alternative foreign
distribution network could have a material adverse impact on the Company's
international sales. The Company will depend in part on its international sales
representatives to obtain needed regulatory approval for the sale of the
Company's products in overseas markets. The failure of its international sales
representatives to obtain or maintain the necessary approvals could have a
material adverse effect on the Company's business, financial condition and
results of operations.
Certain risks are inherent in international operations, including changes in
demand resulting from fluctuations in exchange rates, the risk of government
financed or subsidized competition, changes in trade policies and tariff
regulations. Although the Company's international sales are denominated in
dollars, fluctuations in foreign currencies can impact the prices quoted by the
Company to prospective customers and thereby affect the Company's ability to
obtain orders from foreign customers.
Product Liability Risk. The development, manufacture and sale of medical
devices entail significant risks of product liability claims. There can be no
assurance that the amount of the Company's insurance coverage will be adequate
to protect it from product liability claims, that the Company will be able to
obtain adequate coverage at competitive rates in the future, or that the
Company's product liability experience in the future will
<PAGE>
enable it to obtain insurance coverage in the future. Product liability
insurance is expensive, and may not be available on acceptable terms, if at all,
in the future. A successful product liability suit not covered by such insurance
would have a material adverse effect on the Company's business, financial
condition and results of operations.
Influence of Collagen Corporation. An important part of the Company's long-term
strategy is to develop and sell products manufactured from collagen. Cohesion
Technologies Corporation holds approximately 9.2% of the Company's Common Stock.
Cohesion Technologies is entitled to designate one member of the Company's Board
of Directors so long as it holds at least five percent of the Company's Common
Stock on a fully-diluted basis and a representative of Cohesion Technologies
currently serves on the Board of Directors of the Company. In addition, the
Company and Cohesion Technologies are parties to a research and development
agreement, a manufacturing and supply agreement and a distribution agreement
with respect to tissue fixation devices manufactured from collagen-based
materials using Cohesion Technologies' proprietary technology. Pursuant to
those agreements, certain of the Company's products under development will be
based upon patents and intellectual property owned by Cohesion Technologies.
Accordingly, Cohesion Technologies may be able to exercise influence over the
business and financial affairs of the Company. If Cohesion Technologies'
licensed technology is invalidated or challenged, the Company's ability to sell
products based on such technology could be severely limited. In the event that
the Company materially breaches any of the terms of its agreements with Cohesion
Technologies, Cohesion Technologies could terminate the Company's license to
develop, manufacture and sell products using Cohesion Technologies' technology,
which could have a material adverse effect on the Company's business, financial
condition and results of operations.
Risk of Intense Competition. The medical device industry is highly competitive
and characterized by innovation and rapid technological change. Among the
Company's principal competitors are Mitek Surgical Products, Inc. ("Mitek"), a
division of Johnson & Johnson, the Zimmer and Linvatec divisions of Bristol-
Meyers Squibb Company and ConMed Inc. respectively, Smith & Nephew Endoscopy,
("Dyonics" and "Acufex"), a subsidiary of Smith & Nephew, Inc., Arthrotek Inc.,
a division of Biomet, Inc. and Arthrex, Inc. Each of these competitors has
significantly greater financial, manufacturing, marketing, distribution and
technical resources than the Company and a greater share of the tissue fixation
market than the Company. In addition, a number of smaller companies are
entering or have entered the tissue fixation market. Dyonics, Inc. and Mitek
have already released to the market a number of bioabsorbable products. Many
of the Company's competitors have large existing sales organizations devoted to
a wide variety of orthopedic products. These companies are well capitalized and
may be able to withstand price pressures and deep discounting better than the
Company. The Company has a small number of sales employees and independent
sales representatives focused on tissue fixation devices in the sports medicine
market and with relatively little experience selling the Company's products.
There can be no assurance that the Company's competitors will not succeed in
developing technologies and products that are more effective or less costly than
any which have been developed or may be developed by the Company or that would
render the Company's products obsolete or not competitive.
Price Pressure Resulting From Consolidation of Health Care Industry. The health
care industry is undergoing rapid change and consolidation as health care
systems merge to effect cost savings and operating efficiencies. In addition, a
number of large, national buying consortiums have formed to engage in group
purchasing of medical supplies and services in an effort at cost containment for
member hospital systems and health care providers. These consolidated systems
and large purchasing organizations are likely to apply pressure to manufacturers
and distributors of medical devices to reduce the purchase prices of their
goods. Manufacturers such as the Company may be forced to lower prices in
response to those pressures in order for their products to be approved for
purchase by those organizations, which could have a material adverse effect on
the Company's business, financial condition and results of operations.
<PAGE>
Possible Limitations on Third-Party Reimbursement. The Company's products are
generally purchased directly by hospitals and other health care providers, which
in turn bill third-party payors such as Medicare, Medicaid and private insurance
companies. Many of these payors are attempting to control health care costs by
authorizing fewer surgical procedures and by limiting reimbursement for
procedures to fixed amounts. The Company's strategy includes the expansion of
its market by encouraging physicians to use its tissue fixation devices for
procedures that are not routinely performed, or if performed, are performed
without the use of tissue fasteners. Failure by physicians, hospitals and other
users of the Company's products to obtain sufficient reimbursement from third-
party payors for procedures in which the Company's products are used, or adverse
changes in government and private third-party payors' policies toward
reimbursement for such procedures, could have a material adverse effect on the
Company's business, financial condition and results of operations.
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SIGNATURES
Pursuant to the requirements 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.
INNOVASIVE DEVICES, INC,
Date: March 31, 1999 By: /s/ Richard D. Randall
---------------------------------------
Richard D. Randall
President, Chief Executive Officer
and Director
(Principal Executive Officer)
Date: March 31, 1999 By: /s/ James V. Barrile
---------------------------------------
James V. Barrile
Executive Vice President of Finance,
Chief Financial Officer and Treasurer
(Principal Financial Officer)
