Attached files
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EX-31.2 - EXHIBIT 31.2 - OSTEOTECH INC | c04582exv31w2.htm |
EX-32.1 - EXHIBIT 32.1 - OSTEOTECH INC | c04582exv32w1.htm |
EX-32.2 - EXHIBIT 32.2 - OSTEOTECH INC | c04582exv32w2.htm |
EX-31.1 - EXHIBIT 31.1 - OSTEOTECH INC | c04582exv31w1.htm |
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2010
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM to
COMMISION FILE NUMBER: 001-34612
OSTEOTECH, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE | 13-3357370 | |
(STATE OR OTHER JURISDICTION OF | (I.R.S. EMPLOYER | |
INCORPORATION OR ORGANIZATION) | IDENTIFICATION NUMBER) |
51 James Way, Eatontown, New Jersey, 07724
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES, INCLUDING ZIP CODE)
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES, INCLUDING ZIP CODE)
(732) 542-2800
(REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE)
(REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE)
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 þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files).
Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
Large accelerated filer o | Accelerated filer þ | Non-accelerated filer o | Smaller reporting company o | |||
(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Act). Yes o No þ
The number of shares of the registrants common stock, $.01 par value, outstanding as of
August 5, 2010 was 18,126,882.
OSTEOTECH, INC.
FORM 10-Q
Table of Contents
Page No. | ||||||||
PART I. FINANCIAL INFORMATION | ||||||||
2 | ||||||||
3 | ||||||||
4 | ||||||||
5 | ||||||||
12 | ||||||||
18 | ||||||||
19 | ||||||||
PART II. OTHER INFORMATION | ||||||||
20 | ||||||||
20 | ||||||||
20 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 | ||||||||
Exhibit 32.2 |
Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
OSTEOTECH, INC. and SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(dollars in thousands)
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
(Unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
10,686 | 10,708 | ||||||
Accounts receivable, net of allowance of $303 in 2010 and $304 in 2009 |
16,125 | 16,165 | ||||||
Deferred processing costs |
33,185 | 38,562 | ||||||
Inventories |
1,476 | 1,819 | ||||||
Prepaid expenses and other current assets |
2,949 | 3,247 | ||||||
Total current assets |
64,421 | 70,501 | ||||||
Property, plant and equipment, net |
26,952 | 29,575 | ||||||
Other assets |
17,740 | 16,861 | ||||||
Total assets |
109,113 | 116,937 | ||||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable and accrued liabilities |
10,180 | 16,206 | ||||||
Current maturities of capital lease obligation |
1,047 | 994 | ||||||
Total current liabilities |
11,227 | 17,200 | ||||||
Capital lease obligation |
11,644 | 12,181 | ||||||
Other liabilities |
7,073 | 7,270 | ||||||
Total liabilities |
29,944 | 36,651 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $.01 par value; 5,000,000 shares authorized; no shares
issued or outstanding |
||||||||
Common stock, $.01 par value; 70,000,000 shares authorized; issued
18,242,345 shares in 2010 and 18,179,180 shares in 2009 |
182 | 182 | ||||||
Additional paid-in capital |
72,060 | 71,337 | ||||||
Treasury stock, at cost; 115,670 shares in 2010 and 2009 |
(227 | ) | (227 | ) | ||||
Accumulated other comprehensive income |
1,038 | 1,410 | ||||||
Retained earnings |
6,116 | 7,584 | ||||||
Total stockholders equity |
79,169 | 80,286 | ||||||
Total liabilities and stockholders equity |
109,113 | 116,937 | ||||||
See accompanying notes to condensed consolidated financial statements.
- 2 -
Table of Contents
OSTEOTECH, INC. and SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(dollars in thousands, except per share data)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Revenue |
$ | 23,997 | $ | 23,471 | $ | 46,524 | $ | 47,402 | ||||||||
Cost of revenue |
11,922 | 11,940 | 23,479 | 23,904 | ||||||||||||
Gross profit |
12,075 | 11,531 | 23,045 | 23,498 | ||||||||||||
Marketing, selling and general and administrative expenses |
10,390 | 10,768 | 21,093 | 22,386 | ||||||||||||
Research and development expenses |
1,051 | 1,998 | 2,259 | 3,651 | ||||||||||||
11,441 | 12,766 | 23,352 | 26,037 | |||||||||||||
Operating income (loss) |
634 | (1,235 | ) | (307 | ) | (2,539 | ) | |||||||||
Other income (expense): |
||||||||||||||||
Interest income |
24 | 8 | 49 | 24 | ||||||||||||
Interest expense |
(340 | ) | (363 | ) | (704 | ) | (733 | ) | ||||||||
Other |
(147 | ) | 131 | (334 | ) | 48 | ||||||||||
(463 | ) | (224 | ) | (989 | ) | (661 | ) | |||||||||
Income (loss) before income taxes |
171 | (1,459 | ) | (1,296 | ) | (3,200 | ) | |||||||||
Income tax provision (benefit) |
56 | (255 | ) | 172 | (200 | ) | ||||||||||
Net income (loss) |
$ | 115 | $ | (1,204 | ) | $ | (1,468 | ) | $ | (3,000 | ) | |||||
Earnings (loss) per share: |
||||||||||||||||
Basic |
$ | 0.01 | $ | (0.07 | ) | $ | (0.08 | ) | $ | (0.17 | ) | |||||
Diluted |
$ | 0.01 | $ | (0.07 | ) | $ | (0.08 | ) | $ | (0.17 | ) | |||||
Shares used in computing earnings (loss) per share: |
||||||||||||||||
Basic |
18,069,937 | 18,004,217 | 18,098,827 | 17,882,059 | ||||||||||||
Diluted |
18,201,915 | 18,004,217 | 18,098,827 | 17,882,059 | ||||||||||||
See accompanying notes to condensed consolidated financial statements.
- 3 -
Table of Contents
OSTEOTECH, INC. and SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(dollars in thousands)
Six Months Ended | ||||||||
June 30, | ||||||||
2010 | 2009 | |||||||
Cash Flow From Operating Activities |
||||||||
Net loss |
(1,468 | ) | (3,000 | ) | ||||
Adjustments to reconcile net loss to net cash provided by
(used in) operating activities: |
||||||||
Depreciation and amortization |
2,874 | 3,078 | ||||||
Stock-based compensation expense, net |
716 | 842 | ||||||
Changes in current assets and liabilities: |
||||||||
Accounts receivable |
40 | (2,999 | ) | |||||
Deferred processing costs |
4,209 | (2,802 | ) | |||||
Inventories |
343 | (444 | ) | |||||
Receivable from license agreements |
800 | 500 | ||||||
Prepaid expenses and other current assets |
13 | 261 | ||||||
Accounts payable and other liabilities |
(6,164 | ) | (770 | ) | ||||
Net cash provided by (used in) operating activities |
1,363 | (5,334 | ) | |||||
Cash Flow From Investing Activities |
||||||||
Capital expenditures |
(198 | ) | (846 | ) | ||||
Other, net |
(590 | ) | (362 | ) | ||||
Net cash used in investing activities |
(788 | ) | (1,208 | ) | ||||
Cash Flow From Financing Activities |
||||||||
Purchase of treasury stock |
| (102 | ) | |||||
Proceeds from issuance of common stock |
7 | 47 | ||||||
Principal payments on capital lease obligation |
(484 | ) | (436 | ) | ||||
Net cash used in financing activities |
(477 | ) | (491 | ) | ||||
Effect of exchange rate changes on cash |
(120 | ) | 9 | |||||
Net decrease in cash and cash equivalents |
(22 | ) | (7,024 | ) | ||||
Cash and cash equivalents at beginning of period |
10,708 | 18,823 | ||||||
Cash and cash equivalents at end of period |
10,686 | 11,799 | ||||||
Supplementary cash flow data: |
||||||||
Cash paid during the period for interest |
701 | 760 | ||||||
Cash paid (refunded) during the period for taxes |
39 | (36 | ) |
See accompanying notes to condensed consolidated financial statements.
- 4 -
Table of Contents
OSTEOTECH, INC. and SUBSIDIARIES
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
1. Basis of Presentation
General
The accompanying condensed consolidated financial statements included herein, other than the
condensed consolidated balance sheet at December 31, 2009, which has been derived from the audited
balance sheet, are unaudited and reflect all adjustments (consisting only of normal recurring
accruals) considered necessary by management for a fair statement of financial position as of June
30, 2010 and the results of operations for each of the three and six months ended June 30, 2010 and
2009 and cash flows for the six months ended June 30, 2010 and 2009. The results of operations and
cash flows for the respective interim periods are not necessarily indicative of the results to be
expected for the full year. Certain prior year amounts within the condensed consolidated financial
statements have been reclassified to conform to the 2010 presentation. The condensed consolidated
financial statements should be read in conjunction with the audited consolidated financial
statements, which were included as part of Osteotech, Inc.s (the Company) Annual Report on Form
10-K for the year ended December 31, 2009, as filed with the Securities and Exchange Commission.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards
Board (FASB), as updates to the Codification, and other standard setting bodies that are adopted
by the Company as of the specified effective date. Unless otherwise discussed, we believe that the
impact of recently issued standards that are not yet effective will not have a material impact on
the Companys financial position or results of operations upon adoption.
Segment Realignment
Effective April 1, 2010 the Company eliminated client services as a separately reported segment
because it exited that business. Client service revenue and related operating income have been
reclassified to other and segment information for the three and six months ended June 30, 2009
has been restated to reflect the segment realignment. Other includes any products or services
not falling within the following four operating segments:
| Demineralized Bone Matrix (DBM), |
| Hybrid/Synthetic, |
| Traditional Tissue, and |
| Spinal Allograft. |
The determination of the Companys operating segments is based on an assessment by senior
management, as well as a review process with the Audit Committee of the Board of Directors, based
on the Companys current and future business opportunities, current and future products and
technologies, the markets in which it sells, and the revenue and cost make-up of its business
segments.
2. Deferred Processing Costs
Deferred processing costs consist of the following:
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
Unprocessed donor tissue |
$ | 13,200 | $ | 16,692 | ||||
Tissue in process |
4,938 | 4,062 | ||||||
Implantable donor tissue |
15,047 | 17,808 | ||||||
$ | 33,185 | $ | 38,562 | |||||
Unprocessed donor tissue represents the value of such allograft bone tissue expected to be
processed by the Company during the next twelve months. Unprocessed donor tissue expected to be
processed in periods subsequent to one year of $9,643 and $8,475 at June 30, 2010 and December 31,
2009, respectively, are reflected in other assets.
- 5 -
Table of Contents
OSTEOTECH, INC. and SUBSIDIARIES
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
3. Inventories
Inventories consist of the following:
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
Supplies |
$ | 336 | $ | 428 | ||||
Raw materials |
673 | 779 | ||||||
Finished goods |
467 | 612 | ||||||
$ | 1,476 | $ | 1,819 | |||||
4. Revolving Credit Facility
On December 29, 2009, the Company entered into a Revolving Credit and Security Agreement (the
Credit Agreement) with PNC Bank, National Association as lender and agent (PNC). Pursuant to
the terms of the Credit Agreement and upon request, the Company may borrow from PNC up to $10,000
subject to a maximum borrowing base that is based upon an amount equal to 85% of the Companys
eligible receivables (as that term is defined in the Credit Agreement) less such reserves as PNC
reasonably deems proper and necessary. Under the Credit Agreement, the Company is permitted to use
the proceeds of any such borrowings to satisfy its working capital needs and for general corporate
purposes. Borrowings under the Credit Agreement bear interest at one of three variable rates:
PNCs base commercial lending rate plus 2%; the federal funds open rate plus 0.5%; or LIBOR plus
3%. In no event will the interest rate be less than 3%. Borrowings are secured by essentially all
the assets of the Company. Under the Credit Agreement, the Company is obligated to pay PNC a
quarterly facility fee of 0.5% per annum on the unused portion of the Credit Agreement.
The Company is also required to maintain compliance with various financial and other covenants and
conditions, including, but not limited to, a prohibition on paying cash dividends, a requirement
that a fixed charge coverage ratio be maintained beginning on March 31, 2011, and certain
limitations on engaging in affiliate transactions, making acquisitions, incurring additional
indebtedness and making capital expenditures, the breach of any of which would permit PNC to
accelerate the obligations. The Credit Facility also includes subjective acceleration provisions.
Such provisions are based upon, in the reasonable opinion of PNC, the occurrence of any adverse or
material change in the condition or affairs, financial or otherwise, of the Company, which impairs
the interest of PNC.
As of June 30, 2010 and December 31, 2009, there were no amounts outstanding under the Credit
Agreement and the Company is in compliance with all covenants.
5. Stockholders Equity
Stock Compensation Plans
The Companys stock compensation plan authorizes the grant of incentive and non-qualified share
based equity awards to eligible employees, directors, consultants and others with a business
relationship with the Company. Incentive stock options may be granted at prices not less than 100%
of the fair market value on the date of the grant. Other share-based equity awards may be granted
at the discretion of the Compensation Committee of the Board of Directors under terms and
conditions as determined by the Compensation Committee.
- 6 -
Table of Contents
OSTEOTECH, INC. and SUBSIDIARIES
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
The following table details certain information concerning the Companys restricted stock units
(RSUs) and stock options:
RSUs | Options | |||||||||||||||||||
Weighted- | ||||||||||||||||||||
Average | ||||||||||||||||||||
Weighted- | Weighted- | Remaining | ||||||||||||||||||
Average | Average | Contractual | ||||||||||||||||||
Number of | Grant Date | Number of | Exercise | Term | ||||||||||||||||
Shares | Fair Value | Shares | Price | (Years) | ||||||||||||||||
Outstanding, January 1, 2010 |
434,283 | $ | 4.58 | 1,386,812 | $ | 6.04 | ||||||||||||||
Granted |
291,830 | $ | 4.75 | | ||||||||||||||||
Vested RSUs or exercised options |
(87,505 | ) | $ | 3.96 | (2,000 | ) | $ | 3.50 | ||||||||||||
Forfeited, cancelled or expired |
(56,722 | ) | $ | 3.03 | (92,400 | ) | $ | 9.71 | ||||||||||||
Outstanding, June 30, 2010 |
581,886 | $ | 4.91 | 1,292,412 | $ | 5.78 | 3.87 | |||||||||||||
Options exercisable |
1,192,412 | $ | 5.86 | 3.44 | ||||||||||||||||
Share-based compensation, included in selling, marketing and general and administrative expenses,
of $435 and $822 for the three and six months ended June 30, 2010, respectively, and $448 and $874
for the three and six months ended June 30, 2009, respectively, resulted in no tax benefit to the
Company as a result of the Company providing a full valuation reserve on all deferred tax assets.
For vesting RSUs, the Company, in accordance with the current operation of its equity award
programs, withholds shares equal to the employees tax liability and, as a result, the Company
effectively pays the tax on its employees behalf. The Company funded employment taxes for
the three and six months ended June 30, 2010 of $14 and $106,
respectively, and $13 and $32 for the comparable prior year periods. Any such shares withheld by the Company are
returned to the pool of available shares and are eligible for re-issuance. Shares of common stock
available for future issuance under the stock compensation plan were 772,153 at June 30, 2010.
At June 30, 2010, the unrecorded non-cash fair value based compensation expense with respect to
nonvested share-based awards was $1,890 and the weighted average period over which that
compensation will be charged to operations is 1.8 years.
6. Income Taxes
Based on internal projections, including the effects of timing differences mainly related to
depreciation and amortization, the Company estimated as of June 30, 2010 and 2009 that it would
generate income for tax purposes. As a result, the Company, after the application of available net
operating loss carry forwards, provided for Federal taxes based on the alternative minimum tax
method, as well as recorded a provision for certain state and foreign taxes. During the three and
six months ended June 30, 2009, certain unrecognized tax positions were effectively settled
resulting in the recognition of a $330 tax benefit. The Company continues not to recognize any
Federal, state or certain foreign tax benefits, which are subject to full valuation allowances in
accordance with FASB Codification Topic (ASC) 740, Income Taxes. The Company intends to
maintain the valuation allowances until sufficient positive evidence exists to support the reversal
of a valuation allowance that the Company has established. The Company evaluates its 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 the Companys strategic plan.
The Company files U.S., state, and foreign income tax returns in jurisdictions with varying
statutes of limitations. Tax years subsequent to 2005 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.
The Companys unrecognized tax benefits (UTBs) at June 30, 2010 and December 31, 2009 were not
material. If the Company prevails in matters for which either a receivable or a liability for a
UTB has been established, is required to pay an amount or utilize NOLs to settle a tax liability,
or estimates regarding a UTB change as a result of changes in facts and circumstances, the
Companys effective tax rate in a given financial reporting period may be
affected. It is expected that the amount of UTBs will change in the next twelve months; however,
the Company does not anticipate such change to be significant.
- 7 -
Table of Contents
OSTEOTECH, INC. and SUBSIDIARIES
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
7. Commitments and Contingencies
Litigation
As discussed more fully in the Companys Annual Report on Form 10-K for the year ended December 31,
2009, the Company was involved in a lawsuit filed on August 8, 2007 by ReSource Tissue Bank (RTB)
against OST Developpement SA (OST), a wholly owned subsidiary of the Company, before the
Commercial Court of Clermond-Ferrand, France, arising from OSTs allegedly unlawful termination of
its exclusive distribution agreement. In April 2010, the Court issued its ruling in the case and
ordered OST to make a nominal payment to RTB. Neither party intends to appeal the Courts ruling.
On July 19, 2010, minSURG International, Inc. (minSURG) sued several entities, including the
Company, in the United States District Court for the Middle District of Florida. MinSURGs
complaint alleges that the Companys FacetLinx product infringes minSURGs U.S. Patent Nos.
7,708,761, D590, 943, and D574,495. The complaint also makes business torts allegations against
the Company, specifically, Lanham Act false advertising, Florida law unfair competition,
defamation, and tortious interference with business and contractual relationship allegations. The
Company was served with the complaint on July 28, 2010. The Company is currently evaluating this
recently filed complaint.
8. Comprehensive Loss
Comprehensive loss for the periods indicated is as follows:
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Net income (loss) |
$ | 115 | $ | (1,204 | ) | $ | (1,468 | ) | $ | (3,000 | ) | |||||
Currency translation adjustments |
(226 | ) | 103 | (372 | ) | (11 | ) | |||||||||
Comprehensive loss |
$ | (111 | ) | $ | (1,101 | ) | $ | (1,840 | ) | $ | (3,011 | ) | ||||
- 8 -
Table of Contents
OSTEOTECH, INC. and SUBSIDIARIES
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
9. Loss Per Share
The following table sets forth the computation of basic and diluted loss per share for the periods
indicated:
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Net income (loss) available to common
stockholders |
$ | 115 | $ | (1,204 | ) | $ | (1,468 | ) | $ | (3,000 | ) | |||||
Denominator for basic earnings (loss)
per share, weighted average common
shares outstanding |
18,069,937 | 18,004,217 | 18,098,827 | 17,882,059 | ||||||||||||
Effect of dilutive securities after application of the treasury stock method: |
||||||||||||||||
Restricted stock units |
113,504 | | | | ||||||||||||
Stock options |
18,474 | | | | ||||||||||||
Denominator for diluted loss per share |
18,201,915 | 18,004,217 | 18,098,827 | 17,882,059 | ||||||||||||
Basic earnings (loss) per share |
$ | 0.01 | $ | (0.07 | ) | $ | (0.08 | ) | $ | (0.17 | ) | |||||
Diluted earnings (loss) per share |
$ | 0.01 | $ | (0.07 | ) | $ | (0.08 | ) | $ | (0.17 | ) | |||||
For the three and six months ended June 30, 2010, common stock equivalent shares, consisting of
stock options and RSUs, of 1,552,677 and 1,803,738 respectively, are excluded from the calculation
of diluted loss per share as their effects are anti-dilutive.
For the three and six months ended June 30, 2009, common stock equivalent shares, consisting of
stock options and RSUs, of 2,223,231 are excluded from the calculation of diluted loss per share as
their effects are antidilutive.
10. Fair Value Measurements
In accordance with ASC 820, Fair Value Measurements and Disclosures (ASC 820) the Company values
its financial assets and liabilities at fair value but, unless required by other provisions of the
Codification, does not value non-financial assets and liabilities at fair value. ASC 820 provides a
framework for measuring fair value, expands disclosures about fair value measurements and
establishes a fair value hierarchy which prioritizes the inputs used in measuring fair value,
summarized as follows:
Level 1: Observable inputs such as quoted prices in active markets for identical assets or
liabilities;
Level 2: Observable market-based inputs or observable inputs that are corroborated by market
data; and
Level 3: Unobservable inputs reflecting the Companys own assumptions.
- 9 -
Table of Contents
OSTEOTECH, INC. and SUBSIDIARIES
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
The following table sets forth the Companys financial assets that were measured at fair value as
of June 30, 2010 and indicates the fair value hierarchy of the valuation techniques utilized by the
Company to determine such fair value:
Quoted Prices in | Significant | |||||||||||
Active Markets | Other | Significant | ||||||||||
for Identical | Observable | Unobservable | ||||||||||
Assets | Inputs | Inputs | ||||||||||
(Level 1) | (Level 2) | (Level 3) | ||||||||||
Asset: |
||||||||||||
Money market funds |
$ | 5,837 | $ | | $ | |
Money market funds are classified as cash and cash equivalents in the Companys condensed
consolidated balance sheets.
11. Operating Segments
Summarized financial information concerning the Companys segments is shown in the following
tables.
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
Revenue: | 2010 | 2009 | 2010 | 2009 | ||||||||||||
DBM |
$ | 14,128 | $ | 14,808 | $ | 27,261 | $ | 28,834 | ||||||||
Hybrid/Synthetic |
2,855 | 647 | 5,235 | 1,395 | ||||||||||||
Traditional Tissue |
4,933 | 5,443 | 10,003 | 10,720 | ||||||||||||
Spinal Allograft |
1,886 | 1,862 | 3,585 | 3,742 | ||||||||||||
Other |
195 | 711 | 440 | 2,711 | ||||||||||||
$ | 23,997 | $ | 23,471 | $ | 46,524 | $ | 47,402 | |||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
Operating income (loss): | 2010 | 2009 | 2010 | 2009 | ||||||||||||
DBM |
$ | 4,381 | $ | 3,768 | $ | 8,556 | $ | 7,700 | ||||||||
Hybrid/Synthetic |
641 | (234 | ) | 927 | (132 | ) | ||||||||||
Traditional Tissue |
483 | 778 | 783 | 1,068 | ||||||||||||
Spinal Allograft |
179 | 307 | (100 | ) | 551 | |||||||||||
Other |
4 | 141 | 16 | 1,205 | ||||||||||||
Corporate |
(5,054 | ) | (5,995 | ) | (10,489 | ) | (12,931 | ) | ||||||||
$ | 634 | $ | (1,235 | ) | $ | (307 | ) | $ | (2,539 | ) | ||||||
In each of the three and six months ended June 30, 2010 and 2009, no customer accounted for more
than 10% of revenue.
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OSTEOTECH, INC. and SUBSIDIARIES
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
Notes to Unaudited Condensed Consolidated Financial Statements
(dollars in thousands, except per share data)
12. Other Income (expense)
Certain components of Other income (expense) for the periods indicated are as follows:
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
Other: | 2010 | 2009 | 2010 | 2009 | ||||||||||||
Foreign exchange gain (loss) |
$ | (134 | ) | $ | 112 | $ | (309 | ) | $ | 42 | ||||||
Other |
(13 | ) | 19 | (25 | ) | 6 | ||||||||||
$ | (147 | ) | $ | 131 | $ | (334 | ) | $ | 48 | |||||||
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Item 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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 and our
Annual Report on Form 10-K for the year ended December 31, 2009.
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, 2009 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, 2010 AND 2009
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 Managements Discussion and Analysis of Financial Condition and Results of Operations
in our Annual Report on Form 10-K for the year ended December 31, 2009 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, 2009.
Net income (loss)
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
(dollars in thousands, | June 30, | June 30, | ||||||||||||||||||||||
except per share amounts) | 2010 | 2009 | Change | 2010 | 2009 | Change | ||||||||||||||||||
Net income (loss) |
$ | 115 | $ | (1,204 | ) | $ | 1,319 | $ | (1,468 | ) | $ | (3,000 | ) | $ | (1,532 | ) | ||||||||
Earnings (loss) per share: |
||||||||||||||||||||||||
Basic |
$ | 0.01 | $ | (0.07 | ) | $ | (0.08 | ) | $ | (0.17 | ) | |||||||||||||
Diluted |
$ | 0.01 | $ | (0.07 | ) | $ | (0.08 | ) | $ | (0.17 | ) |
We generated net income in the second quarter of 2010 while incurring a net loss for the six months
ended June 30, 2010. Results in the quarter ended June 30, 2010 were positively impacted by
improved revenue and operating expense cost containment while, for the six month period ended June
30, 2010, unit sales volume was insufficient to cover our operating expenses. During the three and
six months ended June 30, 2010, we incurred $0.5 million and $0.9 million of costs and expenses,
respectively, related to the investigation of strategic alternatives by the Company. Also, in both
the three and six month periods, currency losses related to the decline in the exchange rate
between the U. S. dollar and the euro negatively impacted our results of operations.
In both the three and six months ended June 30, 2009, we incurred a net loss because our unit sales
volume was insufficient to effectively leverage the fixed cost base of our processing facilities to
cover our operating expenses.
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Revenue
For the three months ended June 30, 2010, revenue was $24.0 million as compared to $23.5 million
for the three months ended June 30, 2009. For the six months ended June 30, 2010, revenue was
$46.5 million as compared to $47.4 million in the comparable prior year period. We plan to
continue to focus our strategic efforts on the expansion of new products from our technology
platforms and to maintain the market position of our existing products lines.
The following table details the components of our revenue for the three and six months ended June
30, 2010 and 2009.
Three Months Ended | Six Months Ended | |||||||||||||||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||||||||||||||
Percent | Percent | |||||||||||||||||||||||||||||||
(dollars in thousands) | 2010 | 2009 | Change | Change | 2010 | 2009 | Change | Change | ||||||||||||||||||||||||
DBM |
$ | 14,128 | $ | 14,808 | $ | (680 | ) | -5 | % | $ | 27,261 | $ | 28,834 | $ | (1,573 | ) | -5 | % | ||||||||||||||
Hybrid/Synthetic |
2,855 | 647 | 2,208 | 341 | % | 5,235 | 1,395 | 3,840 | 275 | % | ||||||||||||||||||||||
Traditional Tissue |
4,933 | 5,443 | (510 | ) | -9 | % | 10,003 | 10,720 | (717 | ) | -7 | % | ||||||||||||||||||||
Spinal Allograft |
1,886 | 1,862 | 24 | 1 | % | 3,585 | 3,742 | (157 | ) | -4 | % | |||||||||||||||||||||
Other |
195 | 711 | (516 | ) | -73 | % | 440 | 2,711 | (2,271 | ) | -84 | % | ||||||||||||||||||||
$ | 23,997 | $ | 23,471 | $ | 526 | 2 | % | $ | 46,524 | $ | 47,402 | $ | (878 | ) | -2 | % | ||||||||||||||||
DBM Segment revenue, which consists of revenue from the sale of Grafton® DBM and Xpanse® Bone
Inserts and revenue from the processing of a private label DBM, declined 5% for the three and six
months ended June 30, 2010 as compared to the same period in 2009, primarily as a result of the
decline in domestic unit sales volume.
Revenue in the Hybrid/Synthetic Segment, which consists of revenue from our Magnifuse Technology,
Plexur® Biocomposites, and GraftCage® Spacers, increased 341% and 275% for three and six months
ended June 30, 2010, respectively, as compared to the same periods in 2009 as a result of the
continued expansion of our Magnifuse Bone Graft and Plexur M® Innovative Grafting products.
Traditional Tissue Segment revenue generated from the worldwide distribution of allograft bone
tissue grafts declined 9% and 7%, respectively, for three and six months ended June 30, 2010 as
compared to the comparable periods in 2009 primarily due to a decline in international unit sales
volume.
Revenue in the Spinal Allograft Segment in the second quarter of 2010 was relatively flat, compared
to the prior year period, as a result of revenue from the sale of our FacetLinxTM Fusion
Technology product, offsetting a decline in domestic unit sales volume of Graftech® Spacers. For
the six months ended June 30, 2010 Spinal Allograft Segment revenue declined by 4% compared to the
prior year period as a result of revenue from the sale of our FacetLinxTM Fusion
Technology product not totally offsetting the decline in the domestic unit sales volume of
Graftech® Spacers.
In both the second quarter and six months end June 30, 2010, other revenue consisted mainly of
revenue from the international distribution of Xenograft products and miscellaneous other revenue.
In the three and six months ended June 30, 2009, revenue from the processing of allograft bone
tissue for clients, a business we have exited, was $255 and $1,888, respectively.
For the three and six months ended June 30, 2010, domestic revenue was $18.9 million and $36.9
million, respectively, compared to $17.9 million and $37.0 million in the comparable prior year
periods. The increase in domestic revenue in the second quarter of 2010, compared to the
comparable 2009 quarter, mainly results from revenue from new products of $2.5 million, introduced
in the second half of 2009, partially offset by reductions in DBM revenue and revenue from client
services, a business we have exited. During the six months ended June 30, 2010 domestic revenue
from new products of $4.3 million only partially offset declines in DBM and client services revenue
from that reported in 2009.
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For the three and six months ended June 30, 2010, international revenue was $5.1 million and $9.6
million, respectively, compared to $5.6 million and $10.4 million in the same comparable prior year
periods. International
revenue represented 21% of total revenue both in the second quarter of 2010 and for the six months
ended June 30, 2010, compared to 24% and 22%, respectively, of total revenue in the three and six
months ended June 30, 2009. The reduction in international revenue in 2010 mainly results from a
decline in revenue in certain Asian markets which was partially offset by improvements in certain
European markets.
For each of the three and six months ended June 30, 2010 and 2009, no customer accounted for more
than 10% of revenue.
Gross Profit Margin
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
(dollars in thousands) | 2010 | 2009 | 2010 | 2009 | ||||||||||||
Gross Profit |
$ | 12,075 | $ | 11,531 | $ | 23,045 | $ | 23,498 | ||||||||
Gross Margin |
50 | % | 49 | % | 50 | % | 50 | % |
In the second quarter of 2010, gross margin improved from the second quarter of 2009 primarily due
to improved unit sales volume, resulting in our ability to absorb the fixed cost base of our
processing facility, and lower royalty costs. For the six months ended June 30, 2010 our gross
margin was flat compared to the prior year period.
Operating Expenses
Three Months Ended | Six Months Ended | |||||||||||||||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||||||||||||||
Percent | Percent | |||||||||||||||||||||||||||||||
(dollars in thousands) | 2010 | 2009 | Change | Change | 2010 | 2009 | Change | Change | ||||||||||||||||||||||||
Marketing, selling and
general and
administrative |
$ | 10,390 | $ | 10,768 | $ | (378 | ) | -4 | % | $ | 21,093 | $ | 22,386 | $ | (1,293 | ) | -6 | % | ||||||||||||||
Research and
development |
1,051 | 1,998 | (947 | ) | -47 | % | 2,259 | 3,651 | (1,392 | ) | -38 | % | ||||||||||||||||||||
$ | 11,441 | $ | 12,766 | $ | (1,325 | ) | -10 | % | $ | 23,352 | $ | 26,037 | $ | (2,685 | ) | -10 | % | |||||||||||||||
Marketing, selling and general and administrative expenses declined 4% and 6%, respectively, in the
three and six months ended June 30, 2010 compared to the respective 2009 periods primarily due to
lower employee costs and cost containment initiatives. In the three and six months ended June 30,
2010, we incurred $0.5 million and $0.9 million of costs and expenses, respectively, related to the
investigation of strategic alternatives by the Company. In the three and six months ended June 30,
2010, research and development expenses decreased 47% and 38%, respectively, as compared to the
respective 2009 periods, primarily due to several new tissue technologies and products that were
still in development in the first half of 2009 moving into commercialization.
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Operating Income (Loss) By Segment
Three Months Ended | Six Months Ended | |||||||||||||||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||||||||||||||
Percent | Percent | |||||||||||||||||||||||||||||||
(dollars in thousands) | 2010 | 2009 | Change | Change | 2010 | 2009 | Change | Change | ||||||||||||||||||||||||
DBM |
$ | 4,381 | $ | 3,768 | $ | 613 | 16 | % | $ | 8,556 | $ | 7,700 | $ | 856 | 11 | % | ||||||||||||||||
Hybrid/Synthetic |
641 | (234 | ) | 875 | 374 | % | 927 | (132 | ) | 1,059 | 802 | % | ||||||||||||||||||||
Traditional Tissue |
483 | 778 | (295 | ) | -38 | % | 783 | 1,068 | (285 | ) | -27 | % | ||||||||||||||||||||
Spinal Allograft |
179 | 307 | (128 | ) | -42 | % | (100 | ) | 551 | (651 | ) | -118 | % | |||||||||||||||||||
Other |
4 | 141 | (137 | ) | -97 | % | 16 | 1,205 | (1,189 | ) | -99 | % | ||||||||||||||||||||
Product Segment Operating Income |
5,688 | 4,760 | 928 | 19 | % | 10,182 | 10,392 | (210 | ) | -2 | % | |||||||||||||||||||||
Corporate |
(5,054 | ) | (5,995 | ) | 941 | -16 | % | (10,489 | ) | (12,931 | ) | 2,442 | -19 | % | ||||||||||||||||||
Operating Income (Loss) |
$ | 634 | $ | (1,235 | ) | $ | 1,869 | 151 | % | $ | (307 | ) | $ | (2,539 | ) | $ | 2,232 | 88 | % | |||||||||||||
Product segment operating income is comprised of segment revenue less material and processing cost
and selling and marketing expenses. Total product segment operating income for the second quarter
of 2010 increased 19% as compared to the comparable prior year quarter due to higher gross profit
and lower selling expenses. For the six months ended June 30, 2010, product segment operating
income declined 2% from the comparable prior year period as a result of lower gross profit
partially being offset by lower selling expenses. As a result, in the second quarter of 2010
product segment operating income, as a percent of revenue, increase to 24% compared to 20% in the
second quarter of 2009, but was relatively constant at 22% during both the six months ended June
30, 2010 and 2009.
Costs and expenses associated with Corporate for the three and six months ended June 30, 2010
declined 16% and 19%, respectively, when compared to the comparable 2009 periods primarily due to
lower employee costs and cost containment initiatives. In the three and six months ended June 30,
2010, we incurred $0.5 million and $0.9 million of costs and expenses, respectively, related to the
investigation of strategic alternatives by the Company.
Other Income (Expense)
For the three and six months ended June 30, 2010, other expense was $0.5 million and $1.0 million,
respectively, compared to $0.2 million and $0.7 million in the respective 2009 periods. Interest
expense associated with our capital lease obligation, declined in the 2010 periods compared to the
2009 periods and interest income on our invested cash balances was not significant. In the second
quarter and six months ended June 30, 2010 we recorded foreign exchange losses of $0.1 million and
$0.3 million, respectively, compared to foreign exchange gains of $0.1 million and $.05 million in
the comparable 2009 periods. The foreign exchange losses in 2010 resulted from the U.S. dollar
strengthening against the euro in 2010 compared to a weakening U.S. dollar against the euro in
2009.
Income Tax Provision
Based on internal projections, including the effects of timing differences mainly related to
depreciation and amortization, we estimated as of June 30, 2010 and 2009 that we would generate
income for tax purposes. As a result, after the application of available net operating loss carry
forwards, we provided for Federal taxes based on the alternative minimum tax method, as well as
recorded a provision for certain state and foreign taxes. During the three and six months ended
June 30, 2009, certain unrecognized tax positions were effectively settled resulting in the
recognition of $0.3 million in tax benefits. We continue not to recognize any Federal, state or
certain foreign tax benefits, which were subject to full valuation allowances in accordance with
Financial Accounting Standards Board Codification Topic 740, 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.
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We file United States, state, and foreign income tax returns in jurisdictions with varying statutes
of limitations. Tax years subsequent to 2005 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 unrecognized tax benefits (UTBs) at June 30, 2010 and 2009 were not material. If we prevail
in matters for which either a receivable or a liability for a UTB has been established, are
required to pay an amount or utilize 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. It is expected that the amount of UTBs will change in
the next twelve months; however, we do not anticipate such change to be significant.
Liquidity and Capital Resources
(dollars in thousands)
(dollars in thousands)
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
Cash and cash equivalents |
$ | 10,686 | $ | 10,708 | ||||
Working Capital |
$ | 53,194 | $ | 53,301 | ||||
Stockholders equity |
$ | 79,169 | $ | 80,286 |
Summary of our cash flow:
Six Months Ended | ||||||||
June 30, | ||||||||
2010 | 2009 | |||||||
Net cash provided by (used in) operating activities |
$ | 1,363 | $ | (5,334 | ) | |||
Net cash used in investing activities |
$ | (788 | ) | $ | (1,208 | ) | ||
Net cash used in financing activities |
$ | (477 | ) | $ | (491 | ) | ||
Effect of foreign currency exchange rates on cash |
$ | (120 | ) | $ | 9 | |||
Net decrease in cash and cash equivalents |
$ | (22 | ) | $ | (7,024 | ) | ||
Cash Flow From Operating Activities
Net cash provided by operating activities was $1.4 million in the first half of 2010 compared to a
consumption of $5.3 million in cash by operating activities in the first half of 2009. The change
resulted primarily from our efforts to more closely manage our investment in working capital and a
reduction in our net loss in the six months ended June 30, 2010 compared to the prior year period.
At June 30, 2010, working capital, excluding cash, was $42.5 million compared to $42.6 million at
December 31, 2009. During the six months ended June 30, 2010, we reduced our investment in
inventory and deferred processing costs by $4.6 million. Offsetting that reduction was a $6.2
million reduction in accounts payable and accrued expenses.
Cash Flow From Investing Activities
Net cash used in investing activities was $0.8 million and $1.2 million for the six months ended
June 30, 2010 and 2009, respectively. We anticipate that for 2010, the funding of capital
expenditures and patent development will be below our 2009 levels.
Cash Flow From Financing Activities
Net cash used in financing activities was $0.5 million for both the six months ended June 30, 2010
and 2009, respectively. Principal payments on our capital lease obligation were $0.5 and $0.4
million in the six months ended June 30, 2010 and 2009, respectively. In the first half of 2009,
we used $0.1 million to repurchase our common stock which was partially offset from the proceeds
from the sale of common stock pursuant to our employee stock purchase plan.
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Table of Contents
Financing Needs
At June 30, 2010, cash and cash equivalents were $10.7 million which approximated our December 31,
2009 balances. We have instituted plans to recover some of our investments in working capital, but
we will still fund additional investments in capital expenditures and make payments under our
capital lease obligation. We are
instituting cost reduction programs to align our infrastructure and initiatives with the size of
our revenue base. In addition, we are currently focused on the launch of several new tissue
products from our new, proprietary technology platforms which we believe will provide revenue
growth in future periods. Revenue growth is the most important factor in achieving the benefits of
our internal financial model by leveraging our processing operation and back office
infrastructure. All of these efforts are important components of our plan to reduce our cash burn
rate. Based on our current projections and estimates, we believe that our currently available cash
and cash equivalents and the cash generated from the actions noted above, will be sufficient to
meet our forecasted cash needs for the next twelve months. We can provide no assurance that our
efforts will be successful to recover some of the investments we have made in working capital, that
our cost reduction programs will be effective, that our new products will be accepted in the market
or that we will realize the benefits of our internal financial model. Our future liquidity and
capital requirements will depend upon numerous factors, including:
| the timing and expansion of our internal sales and marketing efforts, including
additional field sales staff, to support our product launches; |
| the progress of our product launch and product development programs and the need and
associated costs relating to regulatory approvals, if any, which may be needed to
commercialize some of our products under development; and |
| the resources we devote to the development, manufacture and marketing of our
services and products. |
Should we not attain our current projections and estimates, the pace of new product introductions
and new product development could be effected. 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.
Credit Facility
On December 29, 2009, we entered into a Revolving Credit and Security Agreement (the Credit
Agreement) with PNC Bank, National Association as lender and agent (PNC). Pursuant to the terms
of the Credit Agreement and upon request, we may borrow from PNC up to $10.0 million subject to a
maximum borrowing base that is based upon an amount equal to 85% of our eligible receivables (as
that term is defined in the Credit Agreement) less such reserves as PNC reasonably deems proper and
necessary. Under the Credit Agreement, we are permitted to use the proceeds of any such borrowings
to satisfy our working capital needs and for general corporate purposes. Borrowings under the
Credit Agreement bear interest at one of three variable rates: PNCs base commercial lending rate
plus 2%; the federal funds open rate plus 0.5%; or LIBOR plus 3%. In no event will the interest
rate be less than 3%. Borrowings are secured by essentially all our assets. Under the Credit
Agreement, we are obligated to pay PNC a quarterly facility fee of 0.5% per annum on the unused
portion of the Credit Agreement.
We are also required to maintain compliance with various financial and other covenants and
conditions, including, but not limited to, a prohibition on paying cash dividends, a requirement
that a fixed charge coverage ratio be maintained beginning on June 30, 2011, and certain
limitations on engaging in affiliate transactions, making acquisitions, incurring additional
indebtedness and making capital expenditures, the breach of any of which would permit PNC to
accelerate the obligations. The Credit Facility also includes subjective acceleration provisions.
Such provisions are based upon, in the reasonable opinion of PNC, the occurrence of any adverse or
material change in the condition or affairs, financial or otherwise, of us, which impairs the
interest of PNC.
As of June 30, 2010, there were no amounts outstanding under the Credit Agreement and we are in
compliance with all covenants.
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, 2010, there were no material changes in our contractual obligations from that
disclosed in Item 7, Managements Discussion and Analysis of Financial Condition and Results of
Operations in our Annual Report on Form 10-K for the year ended December 31, 2009.
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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 and other foreign currencies. 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. We do not hedge our
foreign currency transactions.
The majority of our sales to international stocking distributors are denominated in U.S. dollars.
Generally, our results of operations are directly or indirectly impacted by the strengthening or
weakening of the U.S. dollar against other foreign currencies, especially the euro, in countries to
which we sell. During the three and six months ended June 30, 2010, the U.S. dollar strengthened
against the euro resulting in our incurring a loss whereas in the respective prior year periods the
U.S. dollar weakened resulting in gains.
Litigation
As discussed more fully in 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, 2009, we were
involved in a lawsuit filed on August 8, 2007 by ReSource Tissue Bank (RTB) against OST
Developpement SA (OST), our wholly owned subsidiary, before the Commercial Court of
Clermond-Ferrand, France, arising from OSTs allegedly unlawful termination of its exclusive
distribution agreement. In April 2010, the Court issued its ruling in the case and ordered OST to
make a nominal payment to RTB. Neither party intends to appeal the Courts ruling.
On July 19, 2010, minSURG International, Inc. (minSURG) sued several entities, including us, in
the United States District Court for the Middle District of Florida. MinSURGs complaint alleges
that the Companys FacetLinx product infringes minSURGs U.S. Patent Nos. 7,708,761, D590, 943, and
D574,495. The complaint also makes business torts allegations against us, specifically, Lanham Act
false advertising, Florida law unfair competition, defamation, and tortious interference with
business and contractual relationship allegations. We were served with the complaint on July 28,
2010. We are currently evaluating this recently filed complaint.
We are not aware of any other material matters or legal proceedings initiated against us during the
three months ended June 30, 2010.
Government Proceedings
In December 2008, we were advised that during an inspection of donor recovery sites in Bulgaria by
the French regulatory agency, afssaps, deficiencies were identified, unrelated to product
contamination. We have completed additional procedures, and all tissue product can be released
from our self imposed suspension of shipment.
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
For information regarding our exposure to certain market risks, see Item 7A, Quantitative and
Qualitative Disclosures About Market Risk, in our Annual Report on Form 10-K for the year ended
December 31, 2009. Except as discussed below, there have been no significant changes in our market
risk exposures since the fiscal 2009 year-end.
We sell our products to hospitals in the United States and to stocking distributors
internationally. Stocking distributors in turn sell to hospitals or other medical establishments
and, in many instances, individual stocking distributors maintain higher individual balances with
longer payment terms. Loss, termination or changes in financial condition of a distributor, as
well as a change in medical reimbursement regimens by foreign governments where our products are
sold, along with changes in the U.S. dollar/foreign currency exchange rates or changes in local
currency exchange rates relative to the U.S. dollar, in international countries where our
distributors operate, could have a material adverse effect on our financial condition and results
of operations.
At June 30, 2010, international stocking distributors accounted for 31% of our accounts receivable.
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Item 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our principal
executive officer and principal financial officer, we evaluated our disclosure controls and
procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934,
as amended (the Exchange Act)) as of June 30, 2010 related to the recording, processing,
summarization and reporting of information in our reports that we file with the Securities and
Exchange Commission (SEC). These disclosure controls and procedures have been designed to ensure
that material information relating to us, including our subsidiaries, is made known to our
management, including our principal executive officer and principal financial officer, by others
within our organization, and that this information is recorded, processed, summarized, evaluated
and reported, as applicable, within the time periods specified in the SECs rules and forms. Due
to the inherent limitations of control systems, not all misstatements may be detected. Based upon
their evaluation, our principal executive officer and principal financial officer have concluded
that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the
Exchange Act) were effective as of June 30, 2010.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting, as such term is defined
in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act, during the quarter ended June 30, 2010
that has materially affected, or is reasonably likely to materially affect our internal control
over financial reporting.
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PART II. OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
Except as disclosed in Item 2, Litigation, in Part I of this Quarterly Report on Form 10-Q, there
were no material developments that occurred during the six months ended June 30, 2010 in the
proceedings reported under Item 3. Legal Proceedings in our Annual Report on Form 10-K for the year
ended December 31, 2009. We are not aware of any other material legal proceedings initiated
against us during the six months ended June 30, 2010. See Item 2, Litigation, in Part 1 of this
Quarterly Report on Form 10-Q for legal proceedings initiated against us subsequent to June 30,
2010.
Item 1A. RISK FACTORS
In addition to the other information set forth in this report, you should carefully consider the
factors discussed in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December
31, 2009, which could have a material impact on our business, financial condition or results of
operations. The risks described in our 2009 Annual Report on Form 10-K are not the only risks
facing the Company. Additional risks and uncertainties not presently known to us or that we
currently believe to be immaterial may also adversely affect our business, financial condition or
results of operations.
Item 6. EXHIBITS
(a) Exhibits (numbered in accordance with Item 601 of Regulation S-K)
Exhibit | Page | |||||
Number | Description | Number | ||||
3.1 | Restated Certificate of Incorporation of Osteotech, as amended (incorporated by
reference to Exhibit 3.1 to Registrants Annual Report on Form 10-K, filed on March
27, 2002) |
|||||
3.2 | Fifth Amended and Restated Bylaws of Osteotech (incorporated by reference to Exhibit
3.1 to Registrants Current Report on Form 8-K, filed on November 7, 2007) |
|||||
31.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
+ | ||||
31.2 | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
|
+ | ||||
32.1 | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
+ | ||||
32.2 | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
|
+ |
+ | Filed herewith. |
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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.
Date: August 9, 2010 | Osteotech, Inc. (Registrant) |
|||
Date: August 9, 2010 | By: | /s/ Sam Owusu-Akyaw | ||
Sam Owusu-Akyaw | ||||
President and Chief Executive
Officer (Principal Executive Officer) |
||||
Date: August 9, 2010 | By: | /s/ Mark H. Burroughs | ||
Mark H. Burroughs | ||||
Executive Vice President,
Chief Financial Officer (Principal Financial Officer and Chief Accounting Officer) |
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EXHIBIT INDEX
Exhibit | Page | |||||
Number | Description | Number | ||||
31.1 | Certification of Chief Executive Officer pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
|
+ | ||||
31.2 | Certification of Chief Financial Officer pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
|
+ | ||||
32.1 | Certification of Chief Executive Officer pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002
|
+ | ||||
32.2 | Certification of Chief Financial Officer pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002
|
+ |
+ | Filed herewith. |
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