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| OSTE > SEC Filings for OSTE > Form 10-K on 16-Mar-2009 | All Recent SEC Filings |
16-Mar-2009
Annual Report
with our more recently developed technologies. These technology platforms
represent the majority of our revenue, provide the opportunity to expand into
new markets and we believe will drive our future growth.
Our business is to alleviate pain, promote healing and restore function by
developing innovative biologic solutions for regenerative medicine. Our goal is
to utilize our current and future technology platforms to develop tissue forms
and products (collectively referred to herein as "Products") to create procedure
specific solutions to repair, replace or heal bone and tissue loss caused by
trauma, disease or surgical intervention, augment prosthetic implant procedures,
facilitate spinal fusion and replace and/or repair damaged ligaments, tendons
and other tissues within the human body. We expect to achieve this objective by
executing on three main initiatives: development of innovative technologies,
utilization of these technologies to create efficacious products for specific
surgical procedural applications and medical education. We provide our biologic
solutions to orthopedic, spinal, trauma, neurosurgical and oral/maxillofacial
surgeons for use in the various surgical procedures.
During 2008, we accomplished certain milestones as we continued to transform
the Company to one that provides to the medical profession procedure specific
biological solutions as follows:
• In December 2008, we initiated a pivotal clinical trial for our DuraTech™
BioRegeneration Matrix. DuraTech™ is the first of several products under
development based upon our proprietary human collagen technology platform. We
expect to file a 510(k) with the FDA to secure marketing clearance for
DuraTech in the third quarter of 2009.
• In October 2008, we received FDA clearance for our next generation grafting material, MagniFuse™ Bone Graft. MagniFuse™ will provide a range of market opportunities with products specifically designed for use in posterolateral spine, deformity and minimally invasive procedures.
• In May 2008, we announced our Plexur® Technology was to be used in the Craniofacial Reconstruction Program Funded by the Armed Forces Institute of Regenerative Medicine.
• In April 2008, we received FDA clearance to market our Plexur P® Biocomposite in spinal applications. Plexur P® is a porous, resilient scaffold that allows for the rapid absorption and retention of cells to facilitate bone growth.
• In March and July of 2008, we received FDA clearances for our Plexur M™ Biocomposite for application in the pelvis, extremities and spine. Plexur M™ is a uniquely moldable, settable biomaterial, which, when heated, gives surgeons the ability to contour the product into almost any shape.
During 2008, we invested $7.3 million to solidify our tissue supply position
and expanded certain of our tissue supply arrangements. This investment, and our
investment in plant and equipment, including a new enterprise software system,
resulted in our cash declining to $18.8 million at December 31, 2008.
Results of Operations
The following table sets forth our consolidated results of operations for
2008, 2007 and 2006:
Percent Change
2008 2007
Year Ended December 31, vs. vs.
(in thousands) 2008 2007 2006 2007 2006
Revenue $ 103,814 $ 104,277 $ 99,241 - 5 %
Cost of revenue 48,770 50,555 51,439 -4 % -2 %
Gross profit 55,044 53,722 47,802 2 % 12 %
Operating expenses 52,467 50,459 45,455 4 % 11 %
Operating income 2,577 3,263 2,347 -2 % 39 %
Other (expense) (111 ) (589 ) (498 ) 81 % -18 %
Income before income taxes 2,466 2,674 1,849 -8 % 45 %
Income tax expense (benefit) 263 57 (58 ) 361 % -198 %
Net income $ 2,203 $ 2,617 $ 1,907 -16 % 37 %
Earnings per share:
Basic $ .12 $ .15 $ .11
Diluted $ .12 $ .15 $ .11
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Net Income
Net income for the year ended December 31, 2008 was $2.2 million or $.12
diluted earnings per share. Net income included $1.0 million related to a gain
from a litigation settlement and $0.5 million related to the receipt of license
fees. Compared to 2007, net income in 2008 declined primarily from increased
operating expenses to support distribution initiatives and research and
development and was partially offset by improved gross margins.
Net income for the year ended December 31, 2007 was $2.6 million, or $.15
diluted earnings per share, and resulted from increased revenue and improved
gross margins, which were partially offset by higher operating expenses as
compared to 2006. Our investment in distribution effectiveness initiatives, the
costs associated with the settlement of certain litigation, and the non-cash
compensation costs related to grants of equity awards contributed to the
increase in operating expenses.
Revenue
For the year ended December 31, 2008, revenue of $103.8 million was
relatively flat when compared to revenue of $104.3 million for the prior year.
We plan to focus our strategic efforts on expanding the domestic and
international markets for our current and future primary product lines.
The following table details the components of our revenues for the years
presented:
Percent Change
2008 2007
Year Ended December 31, vs. vs.
(in thousands) 2008 2007 2006 2007 2006
DBM Segment $ 61,961 $ 65,794 $ 57,493 -6 % 14 %
Hybrid/Synthetic Segment 3,087 1,760 1,270 75 % 39 %
Traditional Tissue Segment 20,258 17,623 16,955 15 % 4 %
Spinal Allograft Segment 8,499 10,739 13,795 -21 % -22 %
Client Services Segment 8,201 7,621 9,128 8 % -17 %
Other 1,808 740 600 144 % 23 %
$ 103,814 $ 104,277 $ 99,241 - 5 %
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2008 Compared to 2007
DBM Segment revenue, which consists of revenue from the sale of Grafton® DBM
and Xpanse® Bone Inserts and revenue from the processing of two private label
DBMs, declined 4% in 2008 as compared to 2007, primarily as a result of the
decline in private label revenue. Revenue from Grafton® DBM, private label DBM
and Xpanse® Bone Inserts changed 2%, (62)% and 22%, respectively, in 2008
compared to 2007. Revenue from Grafton® DBM was negatively impacted in 2008 as a
result of a decline in average selling prices. The decline in private label
revenue was primarily due to one of our private label DBM customers formally
notifying us of their decision not to renew its current agreement with us upon
the agreement's expiration in March 2009. We recognized $0.5 million of revenue
from this customer in the first quarter of 2008 and the customer has not made
any purchases since.
Revenue in our Hybrid/Synthetic Segment, which reflects sales of our Plexur
P® Biocomposite and GraftCage® Spacers, increased 75% for the year ended
December 31, 2008, compared to the prior year, primarily as a result of a 139%
increase in Plexur P® revenue due to increased unit volume. We do not anticipate
revenue from the distribution of the GraftCage® Spacers to be a significant
contributor to our future revenue stream.
Revenue in our Traditional Tissue Segment, which represents the worldwide
distribution of allograft bone tissue grafts, increased 15% in 2008 as compared
to 2007. The increase in 2008 traditional tissue revenue resulted from increased
unit sales volume, especially in the international market.
Revenue in the Spinal Allograft Segment declined 21% in 2008 as compared to
2007, primarily due to a decrease in unit sales volume that we anticipate will
continue in 2009.
Client Services Segment revenue, which is generated by the processing of
allograft bone tissue for our clients, mainly the Musculoskeletal Transplant
Foundation ("MTF"), increased 8% in 2008 as compared to 2007. Our contractual
agreements with MTF expired at the end of 2008.
We expect to generate some revenue from our relationship with MTF in the first
quarter as the contractual relationship winds down.
Other revenue consists mainly of $0.5 million related to license fees, the
international distribution of xenograft products, sales commissions for the
distribution of traditional tissue processed by others and revenue from the
distribution of the Kinesis™ BMAC™ system. During the year ended December 31,
2008, other revenue increased 144% compared to 2007.
2007 Compared to 2006
DBM Segment revenue increased 14% in 2007 as compared to 2006 primarily as a
result of increased unit volumes. Revenue from Grafton® DBM, private label DBM
and Xpanse™ Bone Inserts increased 6%, 89% and 47%, respectively, in 2007
compared to 2006.
Revenue from our Hybrid/Synthetic Segment represented sales of our PLEXUR P®
Biocomposite and GraftCage® Spacers. The PLEXUR P® Biocomposite contributed
$1.0 million to revenue growth for the year ended December 31, 2007.
Traditional Tissue Segment revenue from the worldwide distribution of
allograft bone tissue grafts increased 4% in the year ended December 31, 2007
from the prior year. The increase in 2007 traditional tissue revenues resulted
from increases in domestic and international unit sales, partially offset by
declines in domestic pricing.
Revenue in our Spinal Allograft Segment declined 22% in the year ended
December 31, 2007 compared to the same period in 2006 primarily due to a
decrease in unit sales volume.
Client Service Segment revenue declined 17% for the year ended December 31,
2007 compared to the prior year.
Major Customers
In 2008, 2007, and 2006, MTF accounted for $14.2 million, $16.2 million, and
$19.4 million of revenue, or 14%, 16%, and 20%, respectively, of consolidated
revenue. Our agreements with MTF expired at December 31, 2008.
Gross Margin
Year Ended December 31,
(in thousands) 2008 2007 2006
Gross Profit $ 55,044 $ 53,722 $ 47,802
Gross Margin 53.0 % 51.5 % 48.2 %
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In both 2008 and 2007 gross margin increased over gross margin levels in the respective prior year, primarily due to increased unit processing volumes, processing efficiencies and better management of inventory risk exposures, such as obsolescence.
Operating Expenses
Percent Change
2008 2007
Year Ended December 31, vs. vs.
(in thousands) 2008 2007 2006 2007 2006
Marketing, selling and general
and administrative $ 45,032 $ 44,801 $ 40,627 - 10 %
Research & development 7,435 5,658 4,828 31 % 17 %
Total $ 52,467 $ 50,459 $ 45,455 4 % 11 %
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Marketing, selling and general and administrative expenses in 2008 were
relatively flat compared to 2007. In 2008, we had higher non-cash compensation
costs for equity awards and increased marketing and selling expenses, compared
to the prior year, offset by lower performance based compensation expense.
Compensation expense related to our equity award program was $1.7 million in
2008 compared to $0.9 million in 2007. Also in 2007, we incurred $1.0 million in
costs associated with the settlement of and legal fees incurred in connection
with certain litigation.
For 2008, research and development expenses increased 31% as compared to
2007, primarily due to the costs incurred for basic research, product
development and process development activities to support the technologies and
products we are developing for future commercialization.
In 2007, marketing, selling and general and administrative expenses increased
10% when compared to 2006, principally due to our investment in improving
worldwide distribution effectiveness, the costs associated with the settlement
of certain litigation, the non-cash compensation costs associated with our
equity award programs and professional fees. Compensation expense related to our
equity awards program was $0.9 million and $0.3 million in 2007 and 2006,
respectively. Research and development expenses in 2007 increased 17% when
compared to 2006, primarily due to our focus on the development of new
technologies and products.
Operating Income
Percent Change
2008 2007
Year Ended December 31, vs. vs.
(in thousands) 2008 2007 2006 2007 2006
DBM Segment $ 18,902 $ 20,105 $ 16,305 -6 % 23 %
Hybrid/Synthetic Segment 5 277 (717 ) -98 % 139 %
Traditional Tissue Segment 3,666 2,470 5,888 48 % -58 %
Spinal Allograft Segment 286 1,941 1,819 -85 % 7 %
Client Services Segment 4,454 5,744 4,240 -22 % 35 %
Other 1,265 334 45 279 % 642 %
28,578 30,871 27,580 -7 % 12 %
Corporate (26,001 ) (27,608 ) (25,233 ) -6 % 9 %
Operating Income $ 2,577 $ 3,263 $ 2,347 -21 % 39 %
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Product segment operating income is comprised of segment revenue less
material and production cost and selling and marketing expenses. Total product
segment operating income of $28.6 million for the year ended December 31, 2008
declined 7% compared to 2007. Segment operating income was negatively impacted
by higher selling and marketing expenses which were partially offset by a higher
gross profit including the effect of $0.5 million in license fee revenue. In
2008 product segment operating income as a percentage of revenue was 28%
compared to 30% in the prior year.
Costs and expenses associated with Corporate Segment declined 6% for 2008
compared to last year. In 2008, higher research and development expenses were
offset by lower performance compensation expenses while in 2007, we also
incurred a litigation settlement of $1.0 million.
Total product segment operating income for the year ended December 31, 2007
of $30.9 million increased 12% as compared to 2006 due to improved gross margin,
which was partially offset by the cost of our distribution effectiveness
initiatives. In 2007, product segment operating income as a percent of revenue
increased to 30% compared to 28% in 2006.
Costs and expenses associated with Corporate increased 9% in 2007 from the
prior year, mainly due to non-cash compensation costs for our equity award
programs and higher professional fees.
Other Income (Expense)
For the year ended December 31, 2008, other expenses of $0.1 million
primarily represents $1.5 million in interest expense associated with our
capital lease obligation offset partially by interest income of $0.4 million and
litigation settlement income of $1.0 million. For the year ended December 31,
2008, aggregate foreign exchange gains and losses were not significant.
For the year ended December 31, 2007, other expenses of $0.6 million
represents $1.6 million of interest expense associated with our capital lease
obligation, partially offset by interest income on invested cash balances of
$1.0 million; a net foreign currency loss of $0.1 million, principally on
intercompany debt, and a $0.1 million gain from a final contingent consideration
payment related to the sale of a foreign subsidiary in 2002.
Other expenses in 2006 of $0.5 million is principally the result of
$1.7 million in interest expense associated with our capital lease obligation,
partially offset by interest income of $0.8 million on invested cash balances, a
net foreign currency gain of $0.3 million, primarily related to intercompany
debt, and a $0.1 million gain from a contingent consideration payment related to
the sale of a foreign subsidiary in 2002.
Future foreign exchange gains and losses, including those related to
intercompany debt, may have a material impact on our results of operations in
the event of significant changes in the exchange rate between the U.S. dollar
and the Euro, although the impact of such gains and losses should not have any
impact on consolidated cash flows.
Income Tax Provision
In 2008 and 2007, after the application of available net operating loss
carryforwards, we provided for Federal income taxes based on the alternative
minimum tax method, as well as a provision for certain state taxes on
alternative methods and foreign taxes. The carryforwards utilized for Federal,
state and foreign purposes carried full valuation allowances. In 2008, we also
recorded a charge for estimated penalties and interest related to our assessment
of uncertain tax positions mainly as a result of an ongoing Federal tax audit.
Our state income tax benefit in 2007 was primarily due to the reversal of
certain domestic state tax reserves and the filing for a state tax refund
related to a prior year, partially offset by a provision for minimum state taxes
in certain jurisdictions. We have evaluated the continuing need for our
valuation allowances for our domestic and foreign deferred tax assets in
accordance with the provisions of the Financial Accounting Standards Board
("FASB") Statement of Financial Accounting Standards No. 109, "Accounting for
Income Taxes" ("SFAS No. 109"), which requires an assessment of both positive
and negative evidence when determining whether it is more likely than not that
deferred tax assets are recoverable, and we have determined based on our
assessment that there is not sufficient positive evidence to support the
reversal of such valuation allowances.
We intend to maintain the valuation allowance until sufficient positive
evidence exists to support the reversal of such valuation allowances. We
evaluate our position with respect to the valuation allowances each quarter by
taking into consideration numerous factors, including, but not limited to: past,
present and forecasted results; the impact in each jurisdiction of operating
activities; and the anticipated effects of our strategic plan.
In 2006, we provided an income tax benefit primarily due to the reversal of
certain domestic state tax reserves, which were no longer required, partially
offset by provisions for 2006 minimum state income taxes. No provision for
federal or foreign taxes was recorded due to the availability of prior year net
operating loss carryforwards, which carried a full valuation allowance, or due
to recognizing a current year taxable loss for which any tax benefits or assets
would be fully offset by the establishment of valuation allowances.
We file U.S., state, and foreign income tax returns in jurisdictions with
varying statutes of limitations. The 2003 through 2008 tax years generally
remain subject to examination by Federal, foreign and most state authorities
including, but not limited to, the United States, France, Bulgaria and the State
of New Jersey. Our 2003 through 2005 Federal tax returns are currently under
examination by the Internal Revenue Service ("IRS") and the State of New Jersey
is examining certain of our 2003 to 2007 state tax filings. We have recently
been advised of an audit of the 2006 and 2007 tax filings by our French
subsidiary.
We are currently working with the IRS to complete and resolve their tax
examination, which is subject to review and approval by the Joint Committee on
Taxation. We anticipate we will owe no additional tax and the aggregate amount
of our available Federal net operating loss carryforwards will not be materially
impacted. Any remaining items disallowed would be deductible in future periods.
Until such time as the Joint Committee on Taxation approval is received, the IRS
examination will not be considered effectively settled for financial reporting
purposes.
Upon our adoption of FASB Interpretation No. 48, "Accounting for Uncertainty
in Income Taxes-An Interpretation of FASB Statement No. 109" ("FIN 48"),
effective January 1, 2007, we had no material liability for unrecognized tax
benefits ("UTBs"). The components of our UTBs are substantially comprised of
deferred tax assets which are subject to a full valuation
allowance. To the extent we prevail in matters for which either a receivable or
a liability for a UTB has been established, or are required to pay an amount or
utilize NOLs to settle a tax liability, or estimates regarding a specific UTB
change, our effective tax rate in a given financial reporting period may be
affected.
During the year ended December 31, 2008, the total amount of our UTBs
declined $0.3 million to $4.0 million. At December 31, 2008, the reduction in
net Federal, state and foreign deferred tax assets of $1.9 million as a result
of UTBs was offset by a similar change in the related valuation allowance.
We expect that the amount will change in the next twelve months due to our
filing of amended Federal and state tax returns, expiring statutes of
limitation, and audit activity. However, we do not anticipate the change to be
significant.
Liquidity and Capital Resources
Working Capital
At December 31, 2008, we had cash and cash equivalents of $18.8 million
compared to $22.8 million at December 31, 2007. Working capital declined to
$55.6 million at December 31, 2008 compared to $58.0 million at December 31,
2007, primarily due to the use of a portion of available cash to invest in
additional tissue inventories of $7.3 million and for capital expenditures of
$5.9 million.
Cash Flows From Operating Activities
Net cash provided by operating activities was $3.4 million in the year ended
December 31, 2008 compared to $8.1 million provided by operating activities in
the prior year. The decrease resulted primarily from an increased investment in
tissue inventories of $12.4 million partially offset by an increase in accounts
payable.
Cash Flows From Investing Activities
Net cash used in investing activities was $6.8 million and $4.0 million for
the years ended December 31, 2008 and 2007, respectively. During the year ended
December 31, 2008, net cash used in investing activity principally relates to
the funding of capital expenditures, including the implementation of a new
enterprise software system, and for production equipment and facilities for new
products.
Cash Flows From Financing Activities
Net cash used in financing activities of $0.5 million in the year ended
December 31, 2008 relates primarily to principal payments on our capital lease
obligation of $0.8 million, our purchase of our own common stock under a
repurchase program approved by our Board of Directors in December 2008,
partially offset by the proceeds from the exercise of stock options and the sale
of common stock pursuant to our employee stock purchase plan. In 2007, proceeds
received from the exercise of stock options and the sale of common stock
pursuant to our employee stock purchase plan were partially offset by payments
on our capital lease obligation resulting in net cash provided by financing
activities of $0.7 million.
Repurchase of Common Stock
In December 2008, our Board of Directors authorized a stock repurchase
program under which up to $5.0 million of shares of our common stock may be
acquired. Stock repurchases may be executed from time to time at current market
prices through open-market and privately negotiated transactions in such amounts
as management deems appropriate. The final number of shares repurchased will
depend on a variety of factors, including the level of our cash and cash
equivalents, price, corporate and regulatory requirements and other market
conditions. The repurchase program may be terminated at any time without prior
notice.
Further Liquidity and Financing Needs
As of December 31, 2008, we had cash and cash equivalents of $18.8 million.
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