Attached files
file | filename |
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EX-32.1 - EXHIBIT 32.1 - OSTEOTECH INC | c91860exv32w1.htm |
EX-10.1 - EXHIBIT 10.1 - OSTEOTECH INC | c91860exv10w1.htm |
EX-31.1 - EXHIBIT 31.1 - OSTEOTECH INC | c91860exv31w1.htm |
EX-31.2 - EXHIBIT 31.2 - OSTEOTECH INC | c91860exv31w2.htm |
EX-10.2 - EXHIBIT 10.2 - OSTEOTECH INC | c91860exv10w2.htm |
EX-32.2 - EXHIBIT 32.2 - OSTEOTECH INC | c91860exv32w2.htm |
EX-10.3 - EXHIBIT 10.3 - OSTEOTECH INC | c91860exv10w3.htm |
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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 September 30, 2009
or
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 0-19278
OSTEOTECH, INC.
(Exact name of registrant as specified in its charter)
Delaware (State or other jurisdiction of incorporation or organization) |
13-3357370 (I.R.S. Employer Identification No.) |
51 James Way, Eatontown, New Jersey 07724
(Address of principal executive offices)
(Zip Code)
(Address of principal executive offices)
(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 (Do not check if a smaller reporting company) |
Smaller Reporting Company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
The number of shares of the registrants common stock, $.01 par value, outstanding as of November
4, 2009 was 18,017,849.
OSTEOTECH, INC.
FORM 10-Q
Table of Contents
Page No. | ||||||||
PART I. FINANCIAL INFORMATION |
||||||||
3 | ||||||||
4 | ||||||||
5 | ||||||||
6 | ||||||||
13 | ||||||||
19 | ||||||||
20 | ||||||||
PART II. OTHER INFORMATION |
||||||||
21 | ||||||||
21 | ||||||||
21 | ||||||||
Exhibit 10.1 | ||||||||
Exhibit 10.2 | ||||||||
Exhibit 10.3 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 | ||||||||
Exhibit 32.2 |
- 2 -
Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
OSTEOTECH, INC. and SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(dollars in thousands)
September 30, | December 31, | |||||||
2009 | 2008 | |||||||
(Unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 10,607 | $ | 18,823 | ||||
Accounts receivable, net of
allowance of $219 in 2009 and $401
in 2008 |
19,393 | 17,968 | ||||||
Deferred processing costs |
45,476 | 38,715 | ||||||
Inventories |
1,683 | 1,467 | ||||||
Prepaid expenses and other current
assets |
2,303 | 3,115 | ||||||
Total current assets |
79,462 | 80,088 | ||||||
Property, plant and equipment, net |
30,894 | 34,005 | ||||||
Other assets |
8,718 | 13,022 | ||||||
Total assets |
$ | 119,074 | $ | 127,115 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable and accrued
liabilities |
$ | 19,973 | $ | 23,569 | ||||
Current maturities of capital lease
obligation |
968 | 895 | ||||||
Total current liabilities |
20,941 | 24,464 | ||||||
Capital lease obligation |
12,439 | 13,175 | ||||||
Other liabilities |
6,742 | 6,626 | ||||||
Total liabilities |
40,122 | 44,265 | ||||||
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 18,131,447 shares in 2009 and
17,979,846 shares in 2008 |
181 | 180 | ||||||
Additional paid-in capital |
70,844 | 69,801 | ||||||
Treasury stock, at cost; 115,670
shares in 2009 and 65,190 shares in
2008 |
(227 | ) | (125 | ) | ||||
Accumulated other comprehensive income |
1,460 | 1,393 | ||||||
Retained earnings |
6,694 | 11,601 | ||||||
Total stockholders
equity |
78,952 | 82,850 | ||||||
Total liabilities and
stockholders equity |
$ | 119,074 | $ | 127,115 | ||||
See accompanying notes to condensed consolidated financial statements.
- 3 -
Table of Contents
OSTEOTECH, INC. and SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(dollars in thousands, except per share data)
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Revenue |
$ | 22,961 | $ | 24,063 | $ | 70,363 | $ | 79,247 | ||||||||
Cost of revenue |
12,502 | 11,182 | 36,406 | 37,622 | ||||||||||||
Gross profit |
10,459 | 12,881 | 33,957 | 41,625 | ||||||||||||
Marketing, selling and general and administrative expenses |
10,648 | 10,476 | 33,034 | 33,479 | ||||||||||||
Research and development expenses |
1,544 | 1,739 | 5,195 | 5,273 | ||||||||||||
12,192 | 12,215 | 38,229 | 38,752 | |||||||||||||
Operating income (loss) |
(1,733 | ) | 666 | (4,272 | ) | 2,873 | ||||||||||
Other income (expense): |
||||||||||||||||
Interest income |
4 | 104 | 28 | 396 | ||||||||||||
Interest expense |
(358 | ) | (380 | ) | (1,091 | ) | (1,158 | ) | ||||||||
Other |
58 | (270 | ) | 106 | 953 | |||||||||||
(296 | ) | (546 | ) | (957 | ) | 191 | ||||||||||
Income (loss) before income taxes |
(2,029 | ) | 120 | (5,229 | ) | 3,064 | ||||||||||
Income tax provision (benefit) |
(122 | ) | 62 | (322 | ) | 452 | ||||||||||
Net income (loss) |
$ | (1,907 | ) | $ | 58 | $ | (4,907 | ) | $ | 2,612 | ||||||
Earnings (loss) per share: |
||||||||||||||||
Basic |
$ | (0.11 | ) | $ | | $ | (0.27 | ) | $ | 0.15 | ||||||
Diluted |
$ | (0.11 | ) | $ | | $ | (0.27 | ) | $ | 0.15 | ||||||
Shares used in computing earnings (loss) per share: |
||||||||||||||||
Basic |
18,120,350 | 17,881,018 | 17,925,718 | 17,749,402 | ||||||||||||
Diluted |
18,120,350 | 17,993,900 | 17,925,718 | 17,854,319 |
See accompanying notes to condensed consolidated financial statements.
- 4 -
Table of Contents
OSTEOTECH, INC. and SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(dollars in thousands)
Nine Months Ended | ||||||||
September 30, | ||||||||
2009 | 2008 | |||||||
Cash Flow From Operating Activities |
||||||||
Net income (loss) |
$ | (4,907 | ) | $ | 2,612 | |||
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: |
||||||||
Depreciation and amortization |
4,619 | 4,237 | ||||||
Stock-based compensation expense, net |
996 | 916 | ||||||
Changes in current assets and liabilities: |
||||||||
Accounts receivable |
(1,425 | ) | (1,067 | ) | ||||
Deferred processing costs |
(2,112 | ) | (7,533 | ) | ||||
Inventories |
(216 | ) | (204 | ) | ||||
Prepaid expenses and other current assets |
812 | 365 | ||||||
Accounts payable and other liabilities |
(3,596 | ) | 3,045 | |||||
Net cash provided by (used in) operating activities |
(5,829 | ) | 2,371 | |||||
Cash Flow From Investing Activities |
||||||||
Capital expenditures |
(1,267 | ) | (4,923 | ) | ||||
Other, net |
(465 | ) | (692 | ) | ||||
Net cash used in investing activities |
(1,732 | ) | (5,615 | ) | ||||
Cash Flow From Financing Activities |
||||||||
Purchase of treasury stock |
(102 | ) | | |||||
Proceeds from issuance of common stock |
48 | 424 | ||||||
Principal payments on capital lease obligation |
(663 | ) | (597 | ) | ||||
Net cash used in financing activities |
(717 | ) | (173 | ) | ||||
Effect of exchange rate changes on cash |
62 | (29 | ) | |||||
Net decrease in cash and cash equivalents |
(8,216 | ) | (3,446 | ) | ||||
Cash and cash equivalents at beginning of period |
18,823 | 22,777 | ||||||
Cash and cash equivalents at end of period |
$ | 10,607 | $ | 19,331 | ||||
Supplementary cash flow data: |
||||||||
Cash paid during the period for interest |
$ | 1,137 | $ | 1,152 | ||||
Cash paid during the period for taxes |
$ | 110 | $ | 357 |
See accompanying notes to condensed consolidated financial statements.
- 5 -
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, 2008, 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
September 30, 2009 and the results of operations for each of the three and nine months ended
September 30, 2009 and 2008 and cash flows for the nine months ended September 30, 2009 and 2008.
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 2009
presentation. The condensed consolidated financial statement 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, 2008 and the condensed
consolidated financial statements, which were included as part of the Companys Quarterly Report on
Form 10-Q for the quarters ended March 31, 2009 and June 30, 2009 as filed with the Securities and
Exchange Commission (SEC).
Recent Accounting Pronouncements
Except as noted below, or as described in the Companys Annual Report on Form 10-K for the fiscal
year ended December 31, 2008 and the Companys Form 10-Q for the six month period ended June 30,
2009, there have been no recent accounting pronouncements or changes in accounting pronouncements
during the nine months ended September 30, 2009 that are of significance, or potential
significance, to the Company.
Adopted
On January 1, 2008, the Company adopted the effective provisions of the Financial Accounting
Standards Board (FASB) Accounting Standards Codification (ASC) 820-10, which defines fair
value, establishes a framework for measuring fair value in generally accepted accounting
principles, and expands disclosures about fair value measurements. ASC 820-10 applies under a
number of other accounting pronouncements that require or permit fair value measurements. Certain
provisions of ASC 820-10, as they relate to non-financial assets and liabilities, were effective
for the Company beginning on January 1, 2009. The adoption of the remaining provisions of ASC
820-10 had no material impact on the Companys financial statements.
ASC 105-10, Generally Accepted Accounting Principles. ASC 105-10 is effective for the Company
beginning September 15, 2009 and establishes the FASB Standards Accounting Codification
(Codification) as the source of authoritative United States generally accepted accounting
principles (GAAP) recognized by the FASB to be applied to nongovernmental entities and rules and
interpretive releases of the SEC as authoritative GAAP for SEC registrants. The Codification will
supersede all the existing non-SEC accounting and reporting standards upon its effective date and
subsequently, the FASB will not issue new standards in the Form of Statements, FASB Staff Positions
or Emerging Issues Task Force Abstracts but rather, issues accounting standards updates (ASU).
The adoption of ASC 105-10 had no material impact on the Companys financial statements.
ASU 2009-05, Fair Value Measurements and Disclosures (Topic 820) Measuring Liabilities at Fair
Value. ASU 2009-05 is effective for the Company for the period ended September 30, 2009. ASU
2009-05 provides guidance on the fair value measurement of liabilities under ASC 820-10. The
adoption of ASU 2009-05 did not have any effect on the Companys financial statements.
Subsequent Events
In connection with the preparation of the Companys financial statements at September 30, 2009,
subsequent events through November 6, 2009, the date of the issuance of the financial statements,
have been evaluated. The Company is not aware of any significant events that occurred subsequent
to the balance sheet date but previous to the filing of this report that would have a material
impact on our condensed consolidated financial statements.
- 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)
2. Deferred Processing Costs
Deferred processing costs consist of the following:
September 30, | December 31, | |||||||
2009 | 2008 | |||||||
Unprocessed donor tissue |
$ | 22,461 | $ | 16,922 | ||||
Tissue in process |
6,960 | 4,506 | ||||||
Implantable donor tissue |
16,055 | 17,287 | ||||||
$ | 45,476 | $ | 38,715 | |||||
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 $2,969 and $7,618 at September 30, 2009 and December
31, 2008, respectively, are reflected in other assets.
3. Inventories
Inventories consist of the following:
September 30, | December 31, | |||||||
2009 | 2008 | |||||||
Supplies |
$ | 423 | $ | 478 | ||||
Raw materials |
800 | 533 | ||||||
Finished goods |
460 | 456 | ||||||
$ | 1,683 | $ | 1,467 | |||||
4. Shareholders Equity
Stock Compensation Plans
The Companys stock compensation plans authorize 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.
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, 2009 |
790,663 | $ | 4.88 | 1,390,962 | $ | 7.42 | ||||||||||||||
Granted |
121,528 | $ | 3.41 | 100,000 | $ | 4.74 | ||||||||||||||
Vested RSUs or exercised options |
(207,709 | ) | $ | 6.81 | | $ | | |||||||||||||
Forfeited, cancelled or expired |
(20,749 | ) | $ | 4.17 | (52,900 | ) | $ | 25.90 | ||||||||||||
Outstanding, September 30, 2009 |
683,733 | $ | 4.05 | 1,438,062 | $ | 6.56 | 4.3 | |||||||||||||
Options exercisable |
1,331,812 | $ | 6.71 | 3.8 |
- 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)
The Company issued one stock option in 2009. The Company did not issue stock options during
2008. The fair value of stock options at the date of grant is determined using the Black-Scholes
option-pricing model. The following assumptions were used to value the stock options:
Dividend yield |
0 | |||
Expected term (years) |
8.5 | |||
Expected volatility |
73.4 | % | ||
Risk-free interest rate |
3.38 | % | ||
Fair value of options granted |
$ | 3.58 |
The expected volatility is based on the historical volatility of the common shares of the Company,
and the risk-free interest rate is based on the United States Treasury yield in effect at the time
of the grant for the expected term of the stock options. The expected term was developed using the
historical experience.
Share-based compensation, included in selling, marketing and general and administrative expenses,
of $446 and $1,320 for the three and nine months ended September 30, 2009, respectively, and $450
and $1,278 for the three and nine months ended September 30, 2008, 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, at its option, withholds shares equal to the
employees tax liability and, as a result, the Company effectively pays the tax on its employees
behalf.
At September 30, 2009, the unrecorded non-cash fair value based compensation expense with respect
to nonvested share-based awards was $1,905 and the weighted average period over which that
compensation will be charged to operations is 1.4 years.
Shares of common stock available for future issuance under stock compensation plans were 909,355 at
September 30, 2009.
Stock Repurchase Program
In December 2008, the Companys Board of Directors authorized a stock repurchase program under
which up to $5.0 million of the Companys 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 the Companys 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. Through September 30, 2009,
the Company had acquired 115,670 shares of its common stock at an aggregate cost of $227.
5. Income Taxes
For the three and nine months ended September 30, 2009, the Company was not required to provide for
Federal taxes but recorded a provision for certain state taxes. For the three and nine months
ended September 30, 2008, the Company, after the application of available net operating loss
carryforwards, provided for Federal taxes based on the alternative minimum tax method, as well as
recorded a provision for certain state taxes. During the three and nine months ended September 30,
2009, certain unrecognized tax positions were effectively settled resulting in the recognition of
tax benefits of $152 and $482, respectively. The Company continues not to recognize any Federal,
state or certain foreign tax benefits, which were subject to full valuation allowances in
accordance with 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.
- 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)
The Company files 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. During the three months ended September 30, 2009,
the U.S. Internal Revenue Service (IRS) examination of the Companys 2003 through 2004 Federal
tax returns, the State of New Jerseys examination of Companys 2003 through 2006 state income tax
filings and the French tax authoritys audit of the 2006 and 2007 tax filings by the Companys
French subsidiary were concluded. The IRSs examination of the Companys 2005 Federal tax return
was concluded in the second quarter of 2009.
The audits resulted in the Company owing no additional tax, except for a minor amount of taxes
payable as a result of the French tax audit, and the aggregate amount of the Companys available
Federal and State of New Jersey net operating loss carryforwards (NOLs) was not materially
impacted. Certain Federal research and development credit carryforwards were eliminated. Any
remaining minor items disallowed are expected to be deductible in future periods.
The components of the Companys unrecognized tax benefits (UTBs) are substantially comprised of
deferred tax assets which are subject to a full valuation allowance. 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 in changes in facts and circumstances, the Companys effective tax rate in a given financial
reporting period may be affected.
Due mainly to the settlement of certain prior year unrecognized tax positions, subsequent to
December 31, 2008, the Companys gross UTB declined by $2,885 to $787. It is expected that the
amount of UTBs will change in the next twelve months due mainly to expiring statutes of limitation,
however, the Company does not anticipate the change, if any, to be significant.
6. Commitments and Contingencies
Litigation
There were no material developments that occurred during the nine months ended September 30, 2009
in the lawsuits reported in the Companys Annual Report on Form 10-K for the year ended December
31, 2008.
Other Contingencies
During the quarter ended September 30, 2009, as a result of a notice from afssaps, a French
regulatory agency, the Company again began the shipment of allograft tissue grafts processed from
tissue recovered by the Companys Bulgarian subsidiary. Suspension of shipment of these products
had been self-imposed by the Company since December 2008 as a result of deficiencies, unrelated to
product contamination, noted during afssaps inspections of donor recovery sites in Bulgaria. The
Company however, needs to complete additional procedures, which it expects to complete in early
2010, before it releases a remaining $555 in tissue product.
7. Comprehensive Income (Loss)
Comprehensive income (loss) for the periods indicated is as follows:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Net income (loss) |
$ | (1,907 | ) | $ | 58 | $ | (4,907 | ) | $ | 2,612 | ||||||
Currency translation adjustments |
$ | 78 | (400 | ) | 67 | (128 | ) | |||||||||
Comprehensive income (loss) |
$ | (1,829 | ) | $ | (342 | ) | $ | (4,840 | ) | $ | 2,484 | |||||
- 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)
8. Earnings (Loss) Per Share
The following table sets forth the computation of basic and diluted earnings (loss) per share for
the periods indicated:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Net income (loss) available to common
stockholders |
$ | (1,907 | ) | $ | 58 | $ | (4,907 | ) | $ | 2,612 | ||||||
Denominator for basic earnings (loss) per
share, weighted average common shares
outstanding |
18,120,350 | 17,881,018 | 17,925,718 | 17,749,402 | ||||||||||||
Effect of dilutive securities after
application of the treasury stock method: |
||||||||||||||||
Restricted stock units |
| 22,111 | | 8,857 | ||||||||||||
Stock options |
| 90,771 | | 96,060 | ||||||||||||
Denominator for diluted earnings (loss)
per share |
18,120,350 | 17,993,900 | 17,925,718 | 17,854,319 | ||||||||||||
Basic earnings (loss) per share |
$ | (0.11 | ) | $ | | $ | (0.27 | ) | $ | 0.15 | ||||||
Diluted earnings (loss) per share |
$ | (0.11 | ) | $ | | $ | (0.27 | ) | $ | 0.15 | ||||||
For the three and nine months ended September 30, 2009, common stock equivalent shares,
consisting of stock options and RSUs, of 1,682,870 and 1,913,745, respectively, are excluded from
the calculation of diluted loss per share as their effects are antidilutive. For the three and
nine months ended September 30, 2008, common stock equivalent shares, consisting of stock options
and RSUs, of 391,037 and 351,037, respectively, are excluded from the calculation of diluted
earnings per share as their effects are antidilutive.
9. Fair Value Measurements
On January 1, 2008, the Company adopted the effective provisions of ASC 820 as they related to
financial assets and liabilities, and on January 1, 2009, the Company adopted the remaining
provisions of ASC 820 as they relate to non-financial assets and liabilities. Non-financial assets
include goodwill and other intangible assets, property and equipment, and other long-term assets;
non-financial liabilities include asset retirement obligations. 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.
The following table sets forth the Companys financial assets that were measured at fair value as
of September 30, 2009 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 |
$ | 5,770 | $ | | $ | |
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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)
Money market funds are classified as cash and cash equivalents in the Companys condensed
consolidated balance sheets.
10. Operating Segments
Summarized financial information concerning the Companys segments is shown in the following
tables.
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
Revenue: | 2009 | 2008 | 2009 | 2008 | ||||||||||||
DBM |
$ | 14,611 | $ | 14,023 | $ | 43,445 | $ | 47,564 | ||||||||
Hybrid/Synthetics |
894 | 816 | 2,289 | 2,187 | ||||||||||||
Traditional Tissue |
5,101 | 5,246 | 15,821 | 15,606 | ||||||||||||
Spinal Allografts |
1,966 | 1,943 | 5,708 | 6,479 | ||||||||||||
Client Services |
125 | 1,706 | 2,013 | 6,527 | ||||||||||||
Other |
264 | 329 | 1,087 | 884 | ||||||||||||
$ | 22,961 | $ | 24,063 | $ | 70,363 | $ | 79,247 | |||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
Operating Income (loss): | 2009 | 2008 | 2009 | 2008 | ||||||||||||
DBM |
$ | 4,462 | $ | 4,262 | $ | 12,162 | $ | 15,345 | ||||||||
Hybrid/Synthetics |
(261 | ) | 104 | (393 | ) | (2 | ) | |||||||||
Traditional Tissue |
(220 | ) | 923 | 848 | 2,449 | |||||||||||
Spinal Allografts |
320 | (116 | ) | 871 | (100 | ) | ||||||||||
Client Services |
8 | 956 | 1,133 | 4,002 | ||||||||||||
Other |
(418 | ) | 115 | (338 | ) | 577 | ||||||||||
Corporate |
(5,624 | ) | (5,578 | ) | (18,555 | ) | (19,398 | ) | ||||||||
$ | (1,733 | ) | $ | 666 | $ | (4,272 | ) | $ | 2,873 | |||||||
For the three and nine months ended September 30, 2009, no customer accounted for more than
10% of revenue. For the three and nine months ended September 30, 2008, the Company had one
customer which accounted for 12% and 13%, respectively, of revenue.
11. Other Income (Expense)
Certain components of Other Income (Expense) for the periods indicated are as follows:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
Other: | 2009 | 2008 | 2009 | 2008 | ||||||||||||
Foreign exchange gain (loss) |
$ | 74 | $ | (277 | ) | $ | 116 | $ | (53 | ) | ||||||
Litigation Settlement |
| | | 1,000 | ||||||||||||
Other |
(16 | ) | 7 | (10 | ) | 6 | ||||||||||
$ | 58 | $ | (270 | ) | $ | 106 | $ | 953 | ||||||||
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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.
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 NINE MONTHS ENDED SEPTEMBER 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 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, 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 | Nine Months Ended | |||||||||||||||||||||||
(dollars in thousands, except per | September 30, | September 30, | ||||||||||||||||||||||
share amounts) | 2009 | 2008 | Change | 2009 | 2008 | Change | ||||||||||||||||||
Net income (loss) |
$ | (1,907 | ) | $ | 58 | $ | (1,965 | ) | $ | (4,907 | ) | $ | 2,612 | $ | (7,519 | ) | ||||||||
Earnings (loss) per share: |
||||||||||||||||||||||||
Basic |
$ | (0.11 | ) | $ | | $ | (0.27 | ) | $ | 0.15 | ||||||||||||||
Diluted |
$ | (0.11 | ) | $ | | $ | (0.27 | ) | $ | 0.15 |
We generated a net loss for the third quarter and first nine months of 2009 compared to net
income in the comparable prior year periods. The net losses in both periods were attributable to a
more than expected decline in revenue which resulted in lower gross profit and a decline in gross
margin. In the second quarter and first nine months of 2008, we realized income from a litigation
settlement of $1.0 million.
Revenue
For the three months ended September 30, 2009, revenue was $23.0 million as compared to $24.1
million for the three months ended September 30, 2008. For the nine months ended September 30,
2009, revenue was $70.4 million compared to $79.2 million in the comparable prior year period.
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The following table details the components of our revenue for the three and nine months ended
September 30, 2009 and 2008:
Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||||||||
September 30, | September 30, | |||||||||||||||||||||||||||||||
Percent | Percent | |||||||||||||||||||||||||||||||
(dollars in thousands,) | 2009 | 2008 | Change | Change | 2009 | 2008 | Change | Change | ||||||||||||||||||||||||
DBM |
$ | 14,611 | $ | 14,023 | $ | 588 | 4 | % | $ | 43,445 | $ | 47,564 | $ | (4,119 | ) | -9 | % | |||||||||||||||
Hybrid/Synthetic |
$ | 894 | $ | 816 | $ | 78 | 10 | % | $ | 2,289 | $ | 2,187 | $ | 102 | 5 | % | ||||||||||||||||
Traditional Tissue |
$ | 5,101 | $ | 5,246 | $ | (145 | ) | -3 | % | $ | 15,821 | $ | 15,606 | $ | 215 | 1 | % | |||||||||||||||
Spinal Allograft |
$ | 1,966 | $ | 1,943 | $ | 23 | 1 | % | $ | 5,708 | $ | 6,479 | $ | (771 | ) | -12 | % | |||||||||||||||
Client Services |
$ | 125 | $ | 1,706 | $ | (1,581 | ) | -93 | % | $ | 2,013 | $ | 6,527 | $ | (4,514 | ) | -69 | % | ||||||||||||||
Other |
$ | 264 | $ | 329 | $ | (65 | ) | -20 | % | $ | 1,087 | $ | 884 | $ | 203 | 23 | % | |||||||||||||||
$ | 22,961 | $ | 24,063 | $ | (1,102 | ) | -5 | % | $ | 70,363 | $ | 79,247 | $ | (8,884 | ) | -11 | % | |||||||||||||||
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, increased 4% for the three months
ended September 30, 2009, as compared to the same period in 2008, mostly as a result of improved
domestic pricing and an increase in private label DBM revenue. DBM Segment revenue decreased 9%
for the nine months ended September 30, 2009, 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 increased 1%
and 424%, respectively, in the third quarter of 2009 compared to the third quarter of 2008.
Revenue from Grafton® DBM and Xpanse Bone Inserts and revenue from private label DBM decreased 8%
and 22%, respectively, in the first nine months of 2009 compared to the prior year period,
primarily as a result of lower unit sales volumes.
Revenue in the Hybrid/Synthetic Segment, which consists of revenue from our Plexur Biocomposites
and GraftCage® Spacers, increased 10% in the third quarter of 2009 as compared to the same period
in 2008 as a result of an increase in revenue from the GraftCage® Spacers. For the first nine
months of 2009, increased Plexur P® revenue offset a decline in revenue from GraftCage® Spacers
resulting in a 5% increase in revenue compared to the prior year period.
Traditional Tissue Segment revenue generated from the worldwide distribution of allograft bone
tissue grafts decreased 3% in the third quarter of 2009 as compared to the same period in 2008
primarily due to a decrease in international unit sales volume. For the first nine months of 2009,
increased domestic unit sales volume offset a decline in international revenue resulting in an
increase of 1% in revenue compared to the same prior year period.
Revenue in the Spinal Allograft Segment increased 1% in the third quarter of 2009 as compared to
the same period in 2008. For the first nine months of 2009, revenue in the Spinal Allograft
Segment decreased 12% 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 93% and 69%, respectively, in the third quarter and first nine months of 2009
as compared to the same comparable periods in 2008. The revenue generated in 2009 relates mainly
to the winding down of our relationship with the Musculoskeletal Transplant Foundation (MTF) as
our contractual agreements expired at the end of 2008.
For the three and nine months ended September 30, 2009, international revenue was $4.6 million and
$15 million, respectively, or 20% and 21% of total revenue. For the three and nine months ended
September 30, 2008, international revenue was $5.1 million and $17.2 million, respectively, or 21%
and 22% of total revenue. The reduction in revenue for the three and nine months ended September
30, 2009 mainly results from a decline in revenue from the Greek market, as a result of economic and
government reimbursement conditions in Greece, and a loss of revenue in a key Asian market. We also
now expect to recover less of the revenue we lost in the Asian market as a result of our
self-imposed temporary suspension of the distribution of Bulgarian tissue which was lifted early in
the third quarter.
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For the three and nine months ended September 30, 2009, no customer accounted for more than 10% of
revenue. For the three and nine months ended September 30, 2008, MTF accounted for 12% and 13% of
revenue, respectively.
Gross Profit Margin
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
(dollars in thousands) | 2009 | 2008 | 2009 | 2008 | ||||||||||||
Gross Profit |
$ | 10,459 | $ | 12,881 | $ | 33,957 | $ | 41,625 | ||||||||
Gross Margin |
46 | % | 54 | % | 48 | % | 53 | % |
In both the three and nine months ended September 30, 2009, gross margin declined from gross
margin levels in the comparable prior year periods primarily due to lower unit processing volumes
required to support lower revenues. Also impacting gross profit in the three and nine months ended
September 30, 2009 was the cost of our annual plant preventative maintenance shutdown, which
occurred in the second quarter in 2008, and a number of inventory reserves and adjustments.
Operating Expenses
Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||||||||
September 30, | September 30, | |||||||||||||||||||||||||||||||
Percent | Percent | |||||||||||||||||||||||||||||||
(dollars in thousands) | 2009 | 2008 | Change | Change | 2009 | 2008 | Change | Change | ||||||||||||||||||||||||
Marketing, selling and
general and
administrative |
$ | 10,648 | $ | 10,476 | $ | 172 | 2 | % | $ | 33,034 | $ | 33,479 | $ | (445 | ) | -1 | % | |||||||||||||||
Research and
development |
$ | 1,544 | $ | 1,739 | $ | (195 | ) | -11 | % | $ | 5,195 | $ | 5,273 | $ | (78 | ) | -1 | % | ||||||||||||||
$ | 12,192 | $ | 12,215 | $ | (23 | ) | 0 | % | $ | 38,229 | $ | 38,752 | $ | (523 | ) | -1 | % | |||||||||||||||
Marketing, selling and general and administrative expenses were relatively flat in the three
and nine months ended September 30, 2009 compared to the same prior year periods. In the three
months ended September 30, 2009, selling expenses declined in absolute dollars although increased
as a percentage of sales compared to the prior year period. In the nine months ended September 30,
2009, selling expenses increased over the comparable year period both in absolute dollars and as a
percentage of sales. Marketing costs in both the three and nine months ended September 30, 2009
increased over the prior year amounts while general and administrative expenses in the 2009 periods
have remained relatively flat when compared with the prior year periods. In the third quarter and
first nine months of 2009, research and development expenses decreased 11% and 1%, respectively, as
compared to the same periods in 2008, primarily due to several new tissue technologies and products
moving from development to commercialization.
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Operating Income (Loss) By Segment
Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||||||||
September 30, | September 30, | |||||||||||||||||||||||||||||||
Percent | Percent | |||||||||||||||||||||||||||||||
(dollars in thousands,) | 2009 | 2008 | Change | Change | 2009 | 2008 | Change | Change | ||||||||||||||||||||||||
DBM |
$ | 4,462 | $ | 4,262 | $ | 200 | 5 | % | $ | 12,162 | $ | 15,345 | $ | (3,183 | ) | -21 | % | |||||||||||||||
Hybrid/Synthetic |
$ | (261 | ) | $ | 104 | $ | (365 | ) | -351 | % | $ | (393 | ) | $ | (2 | ) | $ | (391 | ) | 19550 | % | |||||||||||
Traditional Tissue |
$ | (220 | ) | $ | 923 | $ | (1,143 | ) | -124 | % | $ | 848 | $ | 2,449 | $ | (1,601 | ) | -65 | % | |||||||||||||
Spinal Allograft |
$ | 320 | $ | (116 | ) | $ | 436 | -376 | % | $ | 871 | $ | (100 | ) | $ | 971 | -971 | % | ||||||||||||||
Client Services |
$ | 8 | $ | 956 | $ | (948 | ) | -99 | % | $ | 1,133 | $ | 4,002 | $ | (2,869 | ) | -72 | % | ||||||||||||||
Other Product Lines |
$ | (418 | ) | $ | 115 | $ | (533 | ) | -463 | % | $ | (338 | ) | $ | 577 | $ | (915 | ) | -159 | % | ||||||||||||
$ | 3,891 | $ | 6,244 | $ | (2,353 | ) | -38 | % | $ | 14,283 | $ | 22,271 | $ | (7,988 | ) | -36 | % | |||||||||||||||
Corporate |
$ | (5,624 | ) | $ | (5,578 | ) | $ | (46 | ) | 1 | % | $ | (18,555 | ) | $ | (19,398 | ) | $ | 843 | -4 | % | |||||||||||
Operating Income (Loss) |
$ | (1,733 | ) | $ | 666 | $ | (2,399 | ) | -360 | % | $ | (4,272 | ) | $ | 2,873 | $ | (7,145 | ) | -249 | % | ||||||||||||
Total product segment operating income, revenue less cost of revenue and marketing and selling
expenses, for the third quarter and first nine months 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. Marketing and selling expenses for the three months ended September 30, 2009 declined
slightly from the comparable 2008 period but for the nine month period September 30, 2009 increased
slightly compared to the prior year period although in both 2009 periods, revenue declined from the
comparable prior year period. As a result, in the third quarter and first nine months of 2009,
product segment operating income, as a percent of revenue, declined to 17% and 20%, respectively,
compared to 26% and 28% respectively in comparable prior year period.
Costs and expenses associated with Corporate for the three months ended September 30, 2009 were
flat when compared to the prior year period but declined in the nine month period ending September
30, 2009 compared to the prior year period primarily due to lower professional fees and performance
based compensation expense.
Other Income (Expense)
In the third quarter and first nine months of 2009, other expense of $0.3 million and $1.0 million,
respectively, primarily consists of interest expense associated with our capital lease obligation
partially offset by foreign exchange gains. Interest income on our invested cash balances was not
significant.
Other expense in the third quarter of 2008 of $0.5 million is principally the result of $0.4
million in interest expense associated with our capital lease obligation and $0.3 million in
foreign exchange loss partially offset by interest income on invested cash balances. Other income
in the first nine months of 2008 of $0.2 million was primarily the result of the litigation
settlement of $1.0 million, interest income and foreign exchange gains of $0.4 million, principally
on intercompany debt, which were partially offset by interest expense of $1.2 million.
Income Tax Provision
For the three and nine months ended September 30, 2009, we were not required to provide for Federal
taxes but recorded a provision for certain state taxes. For the three and nine months ended
September 30, 2008, 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 state taxes. During the three and nine months ended September 30, 2009,
certain unrecognized tax positions were effectively settled resulting in the recognition of tax
benefits of $152 and $482, respectively. We continue not to recognize any Federal, state or
certain foreign tax benefits, which were subject to full valuation allowances in accordance with
ASC 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.
We file United States, 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. During the three months ended September 30, 2009,
the U.S. Internal Revenue Service (IRS) examination of our 2003 through 2004 Federal tax returns,
the State of New Jerseys examination of our 2003 through 2006 state income tax filings and the
French tax authoritys audit of the 2006 and 2007 tax filings by our French subsidiary were
concluded. The IRSs examination of our 2005 Federal tax return was concluded in the second
quarter of 2009.
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Table of Contents
The audits resulted in us owing no additional tax, except for a minor amount of taxes payable as a
result of the French tax audit, and the aggregate amount of our available Federal and State of New
Jersey net operating loss carryforwards (NOLs) was not materially impacted. Certain Federal
research and development credit carryforwards were eliminated. Any remaining minor items
disallowed are expected to be deductible in future periods.
The components of our unrecognized tax benefits (UTBs) are substantially comprised of deferred
tax assets which are subject to a full valuation allowance. 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 in changes
in facts and circumstances, our effective tax rate in a given financial reporting period may be
affected.
Due mainly to the settlement of certain prior year unrecognized tax positions, subsequent to
December 31, 2008, our gross UTB declined by $2,885 to $787. It is expected that the amount of
UTBs will change in the next twelve months due mainly to expiring statutes of limitation; however,
we do not anticipate the change, if any, to be significant.
Liquidity and Capital Resources
September 30, | December 31, | |||||||
(dollars in thousands) | 2009 | 2008 | ||||||
Cash and cash equivalents |
$ | 10,607 | $ | 18,823 | ||||
Working Capital |
$ | 58,521 | $ | 55,624 | ||||
Stockholders equity |
$ | 78,952 | $ | 82,850 |
Summary of our cash flow:
Nine Months Ended | ||||||||
September 30, | ||||||||
2009 | 2008 | |||||||
Net cash provided by (used in) operating activities |
$ | (5,829 | ) | $ | 2,371 | |||
Net cash (used in) investing activities |
$ | (1,732 | ) | $ | (5,615 | ) | ||
Net cash (used in) financing activities |
$ | (717 | ) | $ | (173 | ) | ||
Effect of foreign currency exchange rates on cash |
$ | 62 | $ | (29 | ) | |||
Net decrease in cash and cash equivalents |
$ | (8,216 | ) | $ | (3,446 | ) | ||
Cash Flow From Operating Activities
Net cash used by operating activities was $5.8 million in the first nine months of 2009 compared to
$2.4 million provided by operating activities in the first nine months of 2008. The change
resulted primarily from the net loss for the first nine months 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 nine months
ended September 30, 2009, we reduced our investment in unprocessed tissue and finished goods by
$0.9 million and $1.2 million, respectively, which was partially offset by a $2.5 million increase
in tissue-in-process. During 2009, accounts receivables increased $1.4 million and accounts
payable and accrued expenses declined $3.6 million, both factors negatively impacting cash flow
from operating activities.
Cash Flow From Investing Activities
Net cash used in investing activities was $1.7 million and $5.6 million for the nine months ended
September 30, 2009 and 2008, respectively, and principally relates to the funding of capital
expenditures and intellectual property. We anticipate that for the balance of 2009, the funding of
capital expenditures and patent development will continue to be below our 2008 levels.
Cash Flow From Financing Activities
Net cash used in financing activities of $0.7 million for the nine months ended September 30, 2009
primarily relates to principal payments on our capital lease obligation of $0.7 million. In 2008,
payments of $0.6 million on our
capital lease obligation were offset by proceeds of $0.4 million from the exercise of stock options
and the sale of common stock pursuant to our employee stock purchase plan.
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Table of Contents
Financing Needs
At September 30, 2009, cash and cash equivalents were $10.6 million, a decline of $8.2 million from
cash and cash equivalents of $18.8 million at December 31, 2008. The decline in cash over the
first nine months of 2009 was primarily attributable to the net loss, continued investments in
working capital, funding capital expenditures and making required principal payments on our capital
lease obligation. 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 the
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 the 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 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 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 development can 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.
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 or third quarter of
2009. Through September 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 September 30, 2009, 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, 2008.
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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. 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.
The majority of our sales to international stocking distributors are denominated in U.S. dollars.
Generally, our results of operations are directly or indirectly positively impacted by a weakening
of the U.S. dollar against the euro or a weakening of the U.S. dollar against the other local
foreign currencies in countries to which we sell. During the first half of 2009, the U.S. dollar
remained flat against the euro whereas during the three months ended September 30, 2009 the dollar
weakened against the euro by 4.2% resulting in a gain of $0.1 million in each of the periods.
For the nine months ended September 30, 2008, the U.S. dollar strengthened against the euro by
approximately 3.7% resulting in our incurring a loss of $0.1 million on transactions denominated in
foreign currencies, and $0.1 million on the translation of our non-U.S. operations financial
statements to U.S. dollars. For the three months ended September 30, 2008, a period in which the
U.S. dollar strengthened by 11.9%, transaction and translation losses incurred were $0.3 million
and $0.4 million, respectively.
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 September 30, 2009 in the lawsuits reported in the Companys
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 nine months ended September
30, 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
During the quarter ended September 30, 2009, as a result of a notice from afssaps, a French
regulatory agency, we again began the shipment of allograft tissue grafts processed from tissue
recovered by our Bulgarian subsidiary. Suspension of shipment of these products had been
self-imposed by us since December 2008 as a result of deficiencies, unrelated to product
contamination, noted during afssaps inspections of donor recovery sites in Bulgaria. We however,
need to complete additional procedures, which we expect to be complete in early 2010, before we
release a remaining $555 in tissue product.
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, 2008. Except as discussed below, there have been no significant changes in our market
risk exposures since the fiscal 2008 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/euro exchange rate 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 September 30, 2009 and December 31, 2008, international stocking distributors accounted for 42%
and 30% respectively of our accounts receivable. At September 30, 2009, the balance due from our
stocking distributor in Greece was $1.3 million and represented 7% of our total accounts receivable
an increase from $0.8 million and 5% at December 31, 2008. As a result of delays in Greek
government medical cost reimbursements to hospitals, a substantial portion of this stocking
distributors account with us is past due for which no reserve for uncollectabilty has been
provided. We continue to monitor the reimbursement issue in Greece and the realizability of
amounts due.
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Included in other assets in our consolidated balance sheet is $2.0 million of goodwill related to
our international business. Our assessment of the carrying value of goodwill is dependent on
various assumptions including revenue growth, which is dependent upon expansion of geographic
markets and new product introductions. We annually test goodwill for impairment effective as of
January 1st. The assessment of goodwill is based on a variety of assumption,
which we believe are appropriate to such assessment. Changes to the underlying assumption may
result in a different valuation and such result, could have a material adverse impact on our
results of operations.
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 September 30, 2009 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 September 30, 2009.
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 September 30,
2009 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
There were no material developments that occurred during the three months ended September 30, 2009
in the proceedings reported under Item 3. Legal Proceedings in our Annual Report on Form 10-K for
the year ended December 31, 2008. We are not aware of any other material legal proceedings
initiated against us during the three months ended September 30, 2009.
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, 2008, which could have a material impact on our business, financial condition or results of
operations. The risks described in our 2008 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 AND REPORTS ON FORM 8-K
(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) |
|||||
10.1 | Nontransferable Independent Director Stock Option Agreement, dated July 1, 2009,
between the Company and Kenneth Fallon
|
+ | ||||
10.2 | Amendment No. 1 to Nontransferable Independent Director Stock Option Agreement
between the Company and Kenneth Fallon, dated September 3, 2009
|
+ | ||||
10.3 | Form of Letter Agreement between the Company and Non-Employee Directors, dated
September 3, 2009
|
+ | ||||
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: November 9, 2009 | Osteotech, Inc. (Registrant) |
|||
Date: November 9, 2009 | By: | /s/ Sam Owusu-Akyaw | ||
Sam Owusu-Akyaw | ||||
President and Chief Executive
Officer (Principal Executive Officer) |
||||
Date: November 9, 2009 | 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 | ||||
10.1 | Nontransferable Independent Director Stock Option
Agreement, dated July 1, 2009, between the Company
and Kenneth Fallon
|
+ | ||||
10.2 |
Amendment No. 1 to Nontransferable Independent
Director Stock Option Agreement between the
Company and Kenneth Fallon, dated September 3,
2009
|
+ | ||||
10.3 | Form of Letter Agreement between the Company and
Non-Employee Directors, dated September 3, 2009
|
+ | ||||
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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