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| OSTE > SEC Filings for OSTE > Form 10-Q on 31-Jul-2009 | All Recent SEC Filings |
31-Jul-2009
Quarterly Report
The following discussions should be read in conjunction with the condensed
consolidated financial statements and notes thereto appearing elsewhere in this
Quarterly Report on Form 10-Q.
Information included herein contains "forward-looking statements" which can be
identified by the use of forward-looking terminology such as "believes,"
"expects," "may," "will," "should," or "anticipates" or the negative thereof or
variations thereon or comparable terminology, or by discussions of strategy. No
assurance can be given that the future results covered by the forward-looking
statements will be achieved. Some of the matters set forth in Item 1A, "Risk
Factors," of our Annual Report on Form 10-K for the year ended December 31, 2008
constitute cautionary statements identifying factors with respect to such
forward-looking statements, including certain risks and uncertainties, that
could cause actual results to vary materially from the future results indicated
in such forward-looking statements. Other factors could also cause actual
results to vary materially from the future results indicated in such
forward-looking statements. Except as may be required by law, we undertake no
obligation to update any forward-looking statement to reflect events after the
date of this report.
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2009 AND 2008
Results of Operations
Critical Accounting Policies and Estimates
The preparation of these financial statements requires us to make estimates and
judgments that affect the reported amounts of assets, liabilities, revenue and
expenses, and related disclosure of contingent assets and liabilities. On an
ongoing basis, we evaluate the estimates and may adjust them based upon the
latest information available. These estimates generally include those related to
product returns, bad debts, inventories including purchase commitments, deferred
processing costs including reserves for rework, excess and obsolescence,
long-lived assets, asset retirement obligations, income taxes, stock-based
compensation, contingencies and litigation. We base the estimates on historical
experience and on various other assumptions that are believed to be reasonable
under the circumstances, the results of which form the basis for making
judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Actual results may differ from these
estimates. Our accounting practices are discussed in more detail in
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" in our Annual Report on Form 10-K for the year ended December 31,
2008 as well as in "Recent Accounting Developments" included elsewhere herein.
There have been no significant modifications in our critical accounting policies
or estimates since December 31, 2008.
Net Income (Loss)
Three Months Ended Six Months Ended
(dollars in thousands, except per June 30, June 30,
share amounts) 2009 2008 Change 2009 2008 Change
Net income (loss) $ (1,204 ) $ 1,746 $ (2,950 ) $ (3,000 ) $ 2,554 $ (5,554 )
Earnings (loss) per share:
Basic $ (.07 ) $ .10 $ (.17 ) $ .14
Diluted $ (.07 ) $ .10 $ (.17 ) $ .14
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We generated a net loss in the second quarter and first half of 2009 compared to
net income in the comparable prior year periods. The net losses in both periods
were attributable to an expected decline in revenue which has delivered less
gross profit and lower gross margins on the remaining revenue streams primarily
due to lower production volumes to absorb our fixed cost base. In the second
quarter and first half of 2008 we realized income from a litigation settlement
of $1.0 million.
Revenue
For the three months ended June 30, 2009, revenue was $23.5 million as compared
to $27.6 million for the three months ended June 30, 2008. For the six months
ended June 30, 2009, revenue was $47.4 million compared to $55.2 million in the
comparable prior year period.
The following table details the components of our revenue for the three and six months ended June 30, 2009 and 2008:
Three Months Ended Six Months Ended
June 30, June 30,
Percent Percent
(dollars in thousands) 2009 2008 Change Change 2009 2008 Change Change
DBM $ 14,808 $ 16,575 $ (1,767 ) (11 )% $ 28,834 $ 33,541 $ (4,707 ) (14 )%
Hybrid/Synthetic 647 727 (80 ) (11 )% 1,395 1,371 24 2 %
Traditional Tissue 5,443 5,250 193 4 % 10,720 10,360 360 3 %
Spinal Allograft 1,862 2,286 (424 ) (19 )% 3,742 4,536 (794 ) (18 )%
Client Services 255 2,397 (2,142 ) (89 )% 1,888 4,821 (2,933 ) (61 )%
Other 456 318 138 43 % 823 555 268 48 %
$ 23,471 $ 27,553 $ (4,082 ) (15 )% $ 47,402 $ 55,184 $ (7,782 ) (14 )%
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DBM Segment revenue, which consists of revenue from the sale of Grafton® DBM and
Xpanse™ Bone Inserts and revenue from the processing of private label DBM,
declined 11% and 14% for the three and six months ended June 30, 2009,
respectively, as compared to the same period in 2008, primarily as a result of
the anticipated loss in revenue from the temporary suspension of distributing
tissue recovered by our Bulgarian subsidiary and a decline in domestic unit
sales volume. Revenue from Grafton® DBM and Xpanse™ Bone Inserts and revenue
from private label DBM tissue forms declined 9% and 29%, respectively, in the
second quarter of 2009 compared to the second quarter of 2008 and 12% and 37%,
respectively, in the first half of 2009 compared to the prior year period,
primarily as a result of competitive pricing and lower unit sales volume.
Revenue in the Hybrid/Synthetic Segment, represented sales of our Plexur
Biocomposites and GraftCage® Spacers, declined 11% in the second quarter of 2009
as compared to the same period in 2008 as a result of a decline in revenue from
the GraftCage® Spacers. For the first half of 2009, increased Plexur P® revenue
offset a decline in revenue from GraftCage® Spacers resulting in a 2% increase
over revenue in the comparable prior year period.
Traditional Tissue Segment revenue generated from the worldwide distribution of
allograft bone tissue grafts increased 4% and 3%, respectively, in the second
quarter and first half of 2009 as compared to the same periods in 2008. The
increase in 2009 traditional tissue revenues resulted from increased domestic
unit sales volume.
Revenue in the Spinal Allograft Segment declined 19% and 18%, respectively, in
the second quarter and first half of 2009 as compared to the same periods in
2008 primarily due to a decrease in domestic unit sales volume. We anticipate
continued competitive challenges for our spinal allografts in 2009.
Client Services Segment revenue, which is generated by the processing of
allograft bone tissue for our clients, declined 89% and 61%, respectively, in
the second quarter and first half of 2009 as compared to the same periods in
2008. The revenue generated in 2009 relates mainly to the winding down of our
relationship with Musculoskeletal Transplant Foundation ("MTF") as our
contractual agreements expired at the end of 2008.
For the three and six months ended June 30, 2009, no customer accounted for more
than 10% of revenue. For the three and six months ended June 30, 2008, MTF
accounted for 13% and 14% of revenue, respectively.
Gross Profit Margin
Three Months Ended Six Months Ended
June 30, June 30,
(dollars in thousands) 2009 2008 2009 2008
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In the second quarter and first half of 2009, gross margin declined from gross margin in the comparable prior year periods, primarily due to lower revenue, the recording of certain reserves for our tissue inventories, increased pricing pressures, and a slight change in the mix of our revenue.
Operating Expenses
Three Months Ended Six Months Ended
June 30, June 30,
Percent Percent
(dollars in thousands) 2009 2008 Change Change 2009 2008 Change Change
Marketing, selling and
general and
administrative $ 10,768 $ 11,323 $ (555 ) (5 )% $ 22,386 $ 23,003 $ (617 ) (3 )%
Research and
development 1,998 1,774 224 13 % 3,651 3,534 117 3 %
Total $ 12,766 $ 13,097 $ (331 ) (3 )% $ 26,037 $ 26,537 $ (500 ) (2 )%
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Marketing, selling and general and administrative expenses declined in the
second quarter and first half of 2009 when compared to the prior year periods.
Generally, we had higher sales and marketing costs which were offset by lower
performance-based compensation costs and professional fees. In the second
quarter and first half of 2009, research and development expenses increased 13%
and 3%, respectively, as compared to the same periods in 2008, primarily due to
an increase in staffing. We anticipate that our quarterly research and
development expenditures for the remainder of 2009 will decline from the second
quarter level as several new tissue products have moved from development to
commercialization.
Operating Income (Loss) By Segment
Three Months Ended Six Months Ended
June 30, June 30,
Percent Percent
(dollars in thousands) 2009 2008 Change Change 2009 2008 Change Change
DBM $ 3,768 $ 5,102 $ (1,334 ) (26 )% $ 7,700 $ 11,083 $ (3,383 ) (31 )%
Hybrid/Synthetic (234 ) 66 (300 ) (455 )% (132 ) (106 ) (26 ) (25 )%
Traditional Tissue 778 670 108 16 % 1,068 1,526 (458 ) (30 )%
Spinal Allograft 307 254 53 21 % 551 16 535 3,344 %
Client Services (68 ) 1,617 (1,685 ) (104 )% 1,125 3,046 (1,921 ) (63 )%
Other Product Lines 209 230 (21 ) (9 )% 80 462 (382 ) (83 )%
4,760 7,939 (3,179 ) (40 )% 10,392 16,027 (5,635 ) (35 )%
Corporate (5,995 ) (6,534 ) 539 (8 )% (12,931 ) (13,820 ) 889 (6 )%
Operating Income (Loss) $ (1,235 ) $ 1,405 $ (2,640 ) (188 )% $ (2,539 ) $ 2,207 $ (4,746 ) (215 )%
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Total product segment operating income for the second quarter and first half of
2009 declined as compared to the comparable prior year periods principally due
to lower gross profit as a result of the decline in revenues and higher selling
expenses. In the second quarter and first half of 2009, product segment
operating income, as a percent of revenue, declined to 20% and 22%,
respectively, compared to 29% in both comparable prior year periods.
Costs and expenses associated with Corporate declined in both the three and six
months ended June 30, 2009 from the comparable prior year periods primarily due
to lower performance based compensation and professional fees.
Other Income (Expense)
In the second quarter and first half of 2009, other expense of $0.2 million and
$0.7 million, respectively, primarily represented primarily by interest expense
associated with our capital lease obligation offset partially by foreign
exchange gains. Interest income on our invested cash balances was not
significant.
Other income in the second quarter of 2008 of $0.7 million is principally the
result of proceeds from a litigation settlement of $1.0 million and interest
income of $0.1 million on invested cash balances, partially offset by
$0.4 million in interest expense associated with our capital lease obligation.
Other income in the first half of 2008 of $0.7 million was primarily the result
of the litigation settlement of $1.0 million, interest income of $0.3 million
and foreign exchange gains of $0.2 million, principally on intercompany debt,
which were partially offset by interest expense of $0.8 million.
Income Tax Provision
For the three months ended March 31, 2009, after the application of available
net operating loss carryforwards, we provided for Federal taxes based on the
alternative minimum tax method, as well as recorded a provision for certain
minimum state taxes. During the three months ended June 30, 2009, certain
unrecognized tax positions were effectively settled resulting in the recognition
of a $0.3 million tax benefit. We continue not to recognize any Federal, state
and certain foreign tax benefits, which were subject to full valuation
allowances in accordance with Financial Accounting Standards Board Statement of
Financial Accounting Standard No. 109, "Accounting for Income Taxes." We intend
to maintain the valuation allowances until sufficient positive evidence exists
to support the reversal of a valuation allowance that we have established. 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.
We file U.S., state, and foreign income tax returns in jurisdictions with
varying statutes of limitations. The 2003 through 2007 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 2004 Federal tax returns are currently under
examination by the U.S. Internal Revenue Service ("IRS"). The State of New
Jersey is examining certain of the Company's 2003 through 2007 state tax filings
and an audit of our 2006 and 2007 tax filings by our French subsidiary has
recently commenced.
We have reached a tentative agreement with the IRS regarding the audit of the
Company's Federal tax returns, which is subject to review and approval by the
Joint Committee on Taxation. Pending receipt of the Joint Committee on Taxation
report, the State of New Jersey has completed its review of our filings. The
tentative agreement with the IRS results in us owing no additional Federal or
State of New Jersey tax and the aggregate amount of our available Federal and
State of New Jersey net operating loss carryforwards will not be materially
impacted as a result of either audit although certain Federal research and
development credit carryforwards will be eliminated. Any remaining items
disallowed would be deductible in future periods. Until such time as Joint
Committee on Taxation approval is received, the IRS and State of New Jersey
examinations will not be closed or effectively settled for financial reporting
purposes.
The components of our unrecognized tax benefits ("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, are required to pay an amount and/or
utilize net operating losses ("NOLs") to settle a tax liability or estimates
regarding a UTB change as a result of changes in facts and circumstances, our
effective tax rate in a given financial reporting period may be affected.
Subsequent to December 31, 2008, mainly because of the settlement of certain
prior year unrecognized tax positions, our gross UTB declined by $2.5 million to
$1.5 million. It is expected that the amount of UTBs will change in the next
twelve months due to our filing amended Federal and state tax returns,
resolution of the revenue authority examinations and expiring statutes of
limitation and audit activity; however, we do not anticipate the change, if any,
to be significant.
Liquidity and Capital Resources
June 30, December 31,
(dollars in thousands) 2009 2008
Cash and cash equivalents $ 11,799 $ 18,823
Working Capital $ 57,333 $ 55,624
Stockholders' equity $ 80,626 $ 82,850
Six Months Ended
June 30,
Summary of our cash flow: 2009 2008
Net cash (used in) operating activities $ (5,334 ) $ (100 )
Net cash (used in) investing activities $ (1,208 ) $ (3,573 )
Net cash (used in) financing activities $ (491 ) $ (27 )
Effect of foreign currency exchange rates on cash $ 9 $ 51
Net decrease in cash and cash equivalents $ (7,024 ) $ (3,649 )
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Cash Flow From Operating Activities
Net cash used by operating activities was $5.3 million in the first half of 2009
compared to $0.1 million used by operating activities in the first half of 2008.
The change resulted primarily from a net loss in the first half of 2009 compared
to a profit in the prior year period and an increase in accounts receivable as a
result of more of our customers managing their internal cash position due to the
current economic downturn. During the first half of 2009, we increased our
investment in unprocessed tissue and work-in-process by $3.4 million and
$2.7 million, respectively, which was partially offset by a $3.3 million decline
in finished goods.
Cash Flow From Investing Activities
Net cash used in investing activities was $1.2 million and $3.6 million for the
six months ended June 30, 2009 and 2008, respectively, and principally relates
to funding of capital expenditures and intellectual property. We anticipate that
for the balance of 2009 funding of capital expenditures and patent development
will be below our 2008 levels.
Cash Flow From Financing Activities
Net cash used in financing activities of $0.5 million in the six months ended
June 30, 2009 primarily relates to principal payments on our capital lease
obligation of $0.4 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 2008, proceeds
of $0.4 million from the exercise of stock options and the sale of common stock
pursuant to our employee stock purchase plan were offset by payments of
$0.4 million on our capital lease obligation.
Financing Needs
Based on our current projections and estimates, we believe that our currently
available cash and cash equivalents and anticipated future cash flow from
operations will be sufficient to meet our forecasted cash needs for the next
twelve months. We may seek additional funding to meet the needs of our long-term
strategic plans. We can provide no assurance that such additional funds will be
available, or if available, that such funds will be available on favorable
terms.
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. During
the first quarter of 2009 we repurchased 50,480 shares with an average price
paid of $2.02 per share. We made no repurchases in the second quarter of 2009.
Through June 30, 2009, we had acquired 115,670 shares of our common stock at an
average purchase price of $1.96 per share.
Recent Accounting Developments
For information on new accounting standards, refer to Note 1, Recent Accounting
Pronouncements, in "Notes to Unaudited Condensed Consolidated Financial
Statements" included elsewhere herein.
Contractual Obligations
As of June 30, 2009, there were no material changes in our contractual
obligations from that disclosed in Item 7, "Management's Discussion and Analysis
of Financial Condition and Results of Operations" in our Annual Report on Form
10-K for the year ended December 31, 2008.
Impact of Inflation and Foreign Currency Exchange Fluctuations
The results of operations for the periods discussed have not been materially
affected by inflation. We are subject to foreign currency fluctuations for
material changes in exchange rates between the U.S. dollar and the euro. To the
extent our foreign source revenue grows and represents a larger percentage of
our consolidated revenues and profits, foreign currency translation adjustments
may impact our operating results to a greater extent.
During the first half of 2009, the U.S. dollar remained flat against the euro
whereas in the same period in the prior year the euro strengthened against the
U.S. dollar. This change resulted in our recording a minimal
transaction/translation foreign exchange gain in the first half of 2009 compared
to a gain in the first half of 2008 of $0.2 million.
Litigation
Osteotech is involved in various legal proceedings. For a discussion of these
matters see, Note 14 of "Notes to Consolidated Financial Statements" and Item 3.
Legal Proceedings in our Annual Report on Form 10-K for the year ended
December 31, 2008. There were no material developments that occurred during the
three months ended June 30, 2009 in the lawsuits reported in the Company's
Annual Report on Form 10-K for the year ended December 31, 2008. We are not
aware of any other material matters or legal proceedings initiated against us
during the first six months of 2009.
It is possible that our results of operations or liquidity and capital resources
could be adversely affected by the ultimate outcome of pending litigation or as
a result of the costs of contesting such lawsuits.
Government Proceedings
In December 2008, we were advised that during a November 2008 inspection of
donor recovery sites in Bulgaria by the French regulatory agency, afssaps,
deficiencies were identified. As a precautionary measure, we temporarily
suspended the distribution of allograft tissue grafts processed from tissue
recovered by our subsidiary, TB OsteoCentre Bulgaria EAD ("OCBG"). This action
was not due to product contamination or to any deficiencies with the tissue
grafts. At June 30, 2009, approximately $6,900 in processed and unprocessed
tissue remained subject to our self-imposed suspension of shipments. In
July 2009, we received notice from afssaps which allowed us to lift our
self-imposed temporary suspension and immediately begin processing and
distributing tissue recovered by OCBG. We will be releasing finished OCBG
related allograft tissue grafts following a process agreed to with afssaps and
in accordance with our procedure. At the conclusion of the initial phase of this
process, we will need to complete additional procedures to release a remaining
$600 in tissue product.
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