SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
x | Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the Quarterly Period Ended June 30, 2008.
¨ | 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 0-24517.
ORTHOVITA, INC.
(Exact Name of Registrant as Specified in its Charter)
| | |
Pennsylvania | | 23-2694857 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| |
77 Great Valley Parkway, Malvern, PA | | 19355 |
(Address of principal executive offices) | | (Zip Code) |
Registrant’s Telephone Number, Including Area Code (610) 640-1775.
Not Applicable.
Former Name, Former Address and Former Fiscal Year, If Changed Since Last Report
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 x Yes ¨ No
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
Large accelerated filer ¨ Accelerated filer x Non-accelerated filer ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ¨ Yes x No
Applicable only to corporate issuers:
Indicate the number of shares outstanding of each of the issuer’s classes of Common Stock, as of the latest practicable date.
Class
Outstanding as of August 1, 2008
Common Stock, par value $.01
75,893,689 Shares
ORTHOVITA, INC. AND SUBSIDIARIES
INDEX
2
PART I. FINANCIAL INFORMATION
ITEM I. | FINANCIAL STATEMENTS |
ORTHOVITA, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| | | | | | | | |
| | June 30, 2008 | | | December 31, 2007 | |
| (Unaudited) | | | (Audited) | |
ASSETS | | | | | | | | |
CURRENT ASSETS: | | | | | | | | |
Cash and cash equivalents | | $ | 11,878,131 | | | $ | 10,185,775 | |
Short-term investments | | | 21,672,895 | | | | 38,222,113 | |
Accounts receivable, net of allowance for doubtful accounts of $285,790 and $217,717, respectively | | | 9,841,373 | | | | 8,437,917 | |
Inventories | | | 17,064,516 | | | | 15,611,769 | |
Other current assets | | | 516,931 | | | | 633,058 | |
| | | | | | | | |
Total current assets | | | 60,973,846 | | | | 73,090,632 | |
| | | | | | | | |
Long-term investments | | | 2,506,230 | | | | — | |
Property and equipment, net | | | 10,686,693 | | | | 8,252,394 | |
License Right Intangible, net | | | 7,724,412 | | | | 8,149,608 | |
Other assets | | | 742,053 | | | | 724,504 | |
| | | | | | | | |
Total assets | | $ | 82,633,234 | | | $ | 90,217,138 | |
| | | | | | | | |
| | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | | | | | | | | |
CURRENT LIABILITIES: | | | | | | | | |
Accounts payable | | $ | 4,028,814 | | | $ | 4,151,145 | |
Accrued compensation and related expenses | | | 1,930,947 | | | | 2,284,191 | |
Other accrued expenses | | | 4,385,050 | | | | 4,846,247 | |
| | | | | | | | |
Total current liabilities | | | 10,344,811 | | | | 11,281,583 | |
| | | | | | | | |
LONG-TERM LIABILITIES: | | | | | | | | |
Other long-term liabilities | | | 168,374 | | | | 158,016 | |
Notes payable, net of debt discount of $983,979 and $1,104,624, respectively | | | 24,016,022 | | | | 23,895,376 | |
Derivative liability associated with non-employee stock options | | | 34,747 | | | | 352,746 | |
| | | | | | | | |
Total long-term liabilities | | | 24,219,143 | | | | 24,406,138 | |
| | | | | | | | |
Total liabilities | | | 34,563,954 | | | | 35,687,721 | |
| | | | | | | | |
| | |
COMMITMENTS AND CONTINGENCIES (Note 10) | | | | | | | | |
| | |
SHAREHOLDERS’ EQUITY: | | | | | | | | |
Common Stock, $.01 par value, 100,000,000 shares authorized, 75,862,290 and 75,683,840 shares issued and outstanding, respectively | | | 758,623 | | | | 756,838 | |
Additional paid-in capital | | | 220,600,135 | | | | 219,444,149 | |
Accumulated deficit | | | (173,754,932 | ) | | | (165,919,937 | ) |
Accumulated other comprehensive income | | | 465,454 | | | | 248,367 | |
| | | | | | | | |
Total shareholders’ equity | | | 48,069,280 | | | | 54,529,417 | |
| | | | | | | | |
Total liabilities and shareholders’ equity | | $ | 82,633,234 | | | $ | 90,217,138 | |
| | | | | | | | |
The accompanying notes are an integral part of these statements.
3
ORTHOVITA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| | | | | | | | | | | | | | | | |
| | Three Months Ended June 30 | | | Six Months Ended June 30 | |
| | 2008 | | | 2007 | | | 2008 | | | 2007 | |
PRODUCT SALES | | $ | 19,340,714 | | | $ | 14,851,943 | | | $ | 35,504,996 | | | $ | 28,002,629 | |
COST OF SALES | | | 6,355,907 | | | | 5,073,113 | | | | 12,168,116 | | | | 9,782,202 | |
| | | | | | | | | | | | | | | | |
GROSS PROFIT | | | 12,984,807 | | | | 9,778,830 | | | | 23,336,880 | | | | 18,220,427 | |
| | | | | | | | | | | | | | | | |
OPERATING EXPENSES: | | | | | | | | | | | | | | | | |
General and administrative | | | 3,072,327 | | | | 2,836,696 | | | | 5,530,732 | | | | 5,308,103 | |
Selling and marketing | | | 11,070,617 | | | | 8,312,483 | | | | 21,278,992 | | | | 15,726,623 | |
Research and development | | | 2,132,680 | | | | 1,638,410 | | | | 3,836,289 | | | | 3,411,728 | |
| | | | | | | | | | | | | | | | |
Total operating expenses | | | 16,275,624 | | | | 12,787,589 | | | | 30,646,013 | | | | 24,446,454 | |
| | | | | | | | | | | | | | | | |
OPERATING LOSS | | | (3,290,817 | ) | | | (3,008,759 | ) | | | (7,309,133 | ) | | | (6,226,027 | ) |
LOSS ON DISPOSAL OF ASSETS | | | (145,983 | ) | | | — | | | | (145,983 | ) | | | — | |
GAIN ON SALE OF PRODUCT LINE AND RELATED ASSETS | | | — | | | | — | | | | — | | | | 372,375 | |
INTEREST EXPENSE | | | (473,983 | ) | | | (61,652 | ) | | | (1,162,182 | ) | | | (127,549 | ) |
REVENUE INTEREST EXPENSE | | | — | | | | (351,865 | ) | | | — | | | | (671,494 | ) |
INTEREST INCOME | | | 302,507 | | | | 252,255 | | | | 811,003 | | | | 538,306 | |
| | | | | | | | | | | | | | | | |
LOSS BEFORE INCOME TAX | | | (3,608,276 | ) | | | (3,170,021 | ) | | | (7,806,295 | ) | | | (6,114,389 | ) |
INCOME TAX EXPENSE | | | (14,350 | ) | | | — | | | | (28,700 | ) | | | — | |
| | | | | | | | | | | | | | | | |
NET LOSS | | $ | (3,622,626 | ) | | $ | (3,170,021 | ) | | $ | (7,834,995 | ) | | $ | (6,114,389 | ) |
| | | | | | | | | | | | | | | | |
NET LOSS PER SHARE, BASIC AND DILUTED | | $ | (0.05 | ) | | $ | (0.05 | ) | | $ | (0.10 | ) | | $ | (0.10 | ) |
| | | | | | | | | | | | | | | | |
SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS PER SHARE | | | 75,795,861 | | | | 61,378,088 | | | | 75,774,893 | | | | 61,344,966 | |
| | | | | | | | | | | | | | | | |
The accompanying notes are an integral part of these statements.
4
ORTHOVITA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| | | | | | | | |
| | Six Months Ended June 30 | |
| | 2008 | | | 2007 | |
OPERATING ACTIVITIES: | | | | | | | | |
Net loss | | $ | (7,834,995 | ) | | $ | (6,114,389 | ) |
Adjustments to reconcile net loss to net cash used in operating activities - | | | | | | | | |
Depreciation and amortization | | | 735,926 | | | | 525,620 | |
Amortization of License Right Intangible | | | 425,196 | | | | 425,196 | |
Amortization of debt discount | | | 120,645 | | | | — | |
Compensation expense related to restricted stock and restricted stock units | | | 177,740 | | | | 141,672 | |
Common stock issued for services rendered | | | 20,971 | | | | 11,410 | |
Compensation expense related to employee stock options | | | 455,632 | | | | 420,882 | |
Charge related to exchange of non-employee stock options for common stock | | | 170,082 | | | | 98,972 | |
Fair market value adjustment related to derivative liability associated with non-employee stock options | | | (72,164 | ) | | | (647,953 | ) |
Provision for doubtful accounts | | | 48,132 | | | | 108,092 | |
Loss (gain) on disposal of assets or sale of product line and related assets | | | 145,983 | | | | (372,375 | ) |
(Increase) decrease in - | | | | | | | | |
Accounts receivable | | | (1,451,588 | ) | | | (398,452 | ) |
Inventories | | | (1,452,747 | ) | | | (2,644,240 | ) |
Prepaid revenue interest expense | | | — | | | | (507,972 | ) |
Other current assets | | | 116,127 | | | | (20,650 | ) |
Other assets | | | (127,315 | ) | | | (9,397 | ) |
(Decrease) increase in - | | | | | | | | |
Accounts payable | | | (721,143 | ) | | | 886,939 | |
Accrued compensation and related expenses | | | (353,244 | ) | | | 124,319 | |
Other accrued expenses | | | (877,208 | ) | | | (814,329 | ) |
Other long-term liabilities | | | 10,358 | | | | 4,644 | |
| | | | | | | | |
Net cash used in operating activities | | | (10,463,612 | ) | | | (8,782,011 | ) |
| | | | | | | | |
INVESTING ACTIVITIES: | | | | | | | | |
Purchases of investments | | | (20,749,070 | ) | | | (10,612,370 | ) |
Proceeds from sale and maturity of investments | | | 34,974,053 | | | | 12,050,000 | |
Proceeds from sale of product line | | | — | | | | 458,480 | |
Purchases of property and equipment | | | (2,413,246 | ) | | | (484,258 | ) |
| | | | | | | | |
Net cash provided by investing activities | | | 11,811,737 | | | | 1,411,852 | |
| | | | | | | | |
FINANCING ACTIVITIES: | | | | | | | | |
Repayment of notes payable | | | — | | | | (357,887 | ) |
Repayment of capital lease obligations | | | — | | | | (44,710 | ) |
Costs associated with sale of common stock | | | — | | | | (44,996 | ) |
Proceeds from exercise of common stock options and warrants and common stock purchased under the employee stock purchase plan | | | 87,511 | | | | 298,087 | |
| | | | | | | | |
Net cash provided by (used in) financing activities | | | 87,511 | | | | (149,506 | ) |
| | | | | | | | |
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | | | 256,720 | | | | (68,873 | ) |
| | | | | | | | |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | | | 1,692,356 | | | | (7,588,538 | ) |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | | | 10,185,775 | | | | 16,402,379 | |
| | | | | | | | |
CASH AND CASH EQUIVALENTS, END OF PERIOD | | $ | 11,878,131 | | | $ | 8,813,841 | |
| | | | | | | | |
Supplemental Cash Flow Information | | | | | | | | |
Cash paid for interest expense | | $ | 1,250,000 | | | $ | 127,549 | |
Capital lease obligations incurred | | $ | — | | | $ | 12,610 | |
The accompanying notes are an integral part of these statements.
5
ORTHOVITA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
1. THE COMPANY:
Orthovita, Inc. and subsidiaries (the “Company”) is a spine and orthopedic biosurgery company with proprietary biomaterials and biologic technologies for the development and commercialization of synthetic, biologically active, tissue engineering products. We develop and market synthetic-based biomaterial products for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets. We also market products which complement our biomaterials platforms.
Our near-term commercial business is based on our VITOSS® Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-derived bone material, and VITAGEL® Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS® Bone Augmentation Material technology platform, which is designed for injections into osteoporotic spines to treat vertebral compression fractures (“VCFs”).
In addition, we employ in-house research and development in support of biomaterial and biologic technology platforms. We work jointly with Kensey Nash Corporation (“Kensey”) to develop and commercialize certain products based upon our VITOSS platform, we market VITAGEL and the CELLPAKER® Plasma Collection System under a license with Angiotech Pharmaceuticals (U.S.) Inc. (“Angiotech”), we market VITASURE™ Absorbable Hemostat under a distribution agreement with Medafor, Inc. (“Medafor”), and continue to pursue similar relationships with other biomaterials companies.
In the U.S., we have assembled a field sales network of direct sales representatives and independent sales agencies in order to market VITOSS, VITAGEL, the IMBIBE® Bone Marrow Aspiration System, CELLPAKER and VITASURE. Outside of the U.S., we primarily utilize a network of independent stocking distributors to market VITOSS, CORTOSS, and the ALIQUOT® Delivery System, VITAGEL and CELLPAKER.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
Preparation of Financial Statements and Use of Estimates
The preparation of the consolidated interim financial statements requires us to make assumptions, estimates and judgments that affect the reported amounts of assets and liabilities, the disclosures of contingent assets and liabilities as of the date of the consolidated interim financial statements, and the reported amounts of revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates, including, but not limited to, those related to accounts receivable and inventories. We use authoritative pronouncements, historical experience and other assumptions as the basis for making estimates. Actual results could differ from those estimates.
Our consolidated interim financial statements are unaudited and, in our opinion, include all adjustments (consisting only of normal and recurring adjustments) necessary for a fair presentation of results for these interim periods. The consolidated interim financial statements do not include all of the information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and should be read in conjunction with the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2007, filed with the Securities and Exchange Commission, which includes Consolidated Balance Sheets as of December 31, 2007 and 2006, and related Consolidated Statements of Operations, Shareholders’ Equity and Comprehensive Loss and Cash Flows for each of the years in the three-year period ended December 31, 2007. The results of our operations for any interim period are not necessarily indicative of the results of our operations for any other interim period or for a full year.
Basis of Consolidation
The consolidated financial statements include the accounts of Orthovita, Inc. and our wholly owned subsidiaries. We have eliminated all intercompany balances in consolidation.
6
Net Loss per Common Share
Basic net loss per share excludes potentially dilutive securities and is computed by dividing net loss applicable to common shareholders by the weighted average number of shares of common stock outstanding for the period.
An aggregate of 8,403,387 and 8,187,530 common shares underlying options, restricted stock, restricted stock units and warrants were excluded from our computation of diluted net loss per common share for the six months ended June 30, 2008 and 2007, respectively, because the inclusion of the shares in the calculation would have been anti-dilutive due to our losses.
Accounting for Stock Options Issued to Employees
In accordance with Statement of Financial Accounting Standards (“SFAS”) No. 123R, “Share-Based Payment”, we expense the value of employee stock options and similar awards in our Consolidated Statements of Operations. We use the Black-Scholes option-pricing model to value our employee stock option grants under SFAS No. 123R. Stock-based compensation expense for all stock option awards granted to employees is based on the grant date fair value estimated in accordance with the provisions of SFAS No. 123R and amortized on a straight-line basis over the requisite service period of the award.
The following table sets forth the total stock-based compensation expense for our stock options in accordance with SFAS No. 123R included in our Consolidated Statements of Operations for the three and six months ended June 30, 2008 and 2007.
| | | | | | | | | | | | | | |
| | Three Months Ended June 30 | | | Six Months Ended June 30 | |
OPERATING EXPENSES: | | 2008 | | 2007 | | | 2008 | | 2007 | |
General and administrative | | $ | 86,197 | | $ | 158,897 | | | $ | 155,050 | | $ | 291,900 | |
Selling and marketing | | | 124,301 | | | 39,285 | | | | 213,900 | | | 143,858 | |
Research and development | | | 53,005 | | | (71,375 | ) | | | 86,682 | | | (14,876 | ) |
| | | | | | | | | | | | | | |
Total operating expenses | | $ | 263,503 | | $ | 126,807 | | | $ | 455,632 | | $ | 420,882 | |
| | | | | | | | | | | | | | |
The fair value of all outstanding and unvested stock option awards granted to employees was estimated using the Black-Scholes fair value option pricing model on the date of grant, with the following weighted average assumptions for the three and six months ended June 30, 2008 and 2007:
| | | | | | | | | | | | |
| | Three Months Ended June 30 | | | Six Months Ended June 30 | |
| | 2008 | | | 2007 | | | 2008 | | | 2007 | |
Risk-free interest rate | | 3.66 | % | | 4.90 | % | | 3.56 | % | | 4.64 | % |
Volatility | | 59 | % | | 54 | % | | 59 | % | | 57 | % |
Dividend yield | | 0 | % | | 0 | % | | 0 | % | | 0 | % |
Expected life | | 6 years | | | 5 years | | | 6 years | | | 5 years | |
The weighted average fair value of options granted was $1.50 and $1.51 per share for the three months ended June 30, 2008 and 2007, respectively. The weighted average fair value of options granted was $1.70 and $1.65 per share for the six months ended June 30, 2008 and 2007, respectively.
For the three and six months ended June 30, 2008 and 2007, we calculated historical volatility based upon the daily closing prices of our common stock as quoted on the Nasdaq Global Market (“Nasdaq”) over a prior period having a term equal to the expected life of the stock options.
Recent Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 157, “Fair Value Measurements” (“SFAS No. 157”). SFAS No. 157 clarifies the definition of fair value, establishes a framework for measuring fair value and expands disclosures on fair value measurements. In February 2008, the FASB issued two final staff positions (“FSP”) amending SFAS No. 157. FSP SFAS 157-1 amends SFAS No. 157 to exclude SFAS No. 13,“Accounting for Leases” and its related interpretive accounting pronouncements that address leasing transactions. FSP SFAS 157-2 delays the effective date of SFAS No. 157 until fiscal years beginning after November 15, 2008 for nonfinancial assets and nonfinancial liabilities that are recognized or disclosed at fair value in the financial statements on a nonrecurring basis. We adopted SFAS No. 157 on January 1, 2008, except for the items covered by FSP SFAS 157-2.
7
SFAS No. 157 establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
| • | | Level 1: Observable inputs such as quoted prices in active markets; |
| • | | Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and |
| • | | Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. |
Our short-term and long-term investments are reported at fair value on our consolidated balance sheet based on quoted prices in active markets for identical or comparable assets (Level 1).
In February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities – Including an amendment of FASB Statement No. 115” (“SFAS No. 159”). Under this Standard, we may elect to report certain securities and certain other items at fair value on a contract-by-contract basis with changes in value reported in earnings. This election is irrevocable. SFAS No. 159 is effective for us for the year beginning January 1, 2008. We have elected not to apply the fair value option to any of our eligible financial assets and liabilities.
Comprehensive Loss
We apply SFAS No. 130, “Reporting Comprehensive Income,” which requires companies to classify items of other comprehensive income (loss) separately in the shareholders’ equity section of our consolidated balance sheets. For the three and six months ended June 30, 2008 and 2007, comprehensive loss was:
| | | | | | | | | | | | | | | | |
| | Three Months Ended June 30 | | | Six Months Ended June 30 | |
| | 2008 | | | 2007 | | | 2008 | | | 2007 | |
Net loss | | $ | (3,622,626 | ) | | $ | (3,170,021 | ) | | $ | (7,834,995 | ) | | $ | (6,114,389 | ) |
Total other comprehensive (loss) income | | | (130,592 | ) | | | (56,628 | ) | | | 217,087 | | | | (30,953 | ) |
| | | | | | | | | | | | | | | | |
Comprehensive loss | | $ | (3,753,218 | ) | | $ | (3,226,649 | ) | | $ | (7,617,908 | ) | | $ | (6,145,342 | ) |
| | | | | | | | | | | | | | | | |
3. ACCOUNTING FOR DERIVATIVE LIABILITY ASSOCIATED WITH NON-EMPLOYEE STOCK OPTIONS:
Stock options granted to non-employee consultants are accounted for under SFAS No. 123R during the service and vesting period of the options. However, once the service or vesting period terminates, these options are then accounted for in accordance with Emerging Issues Task Force (“EITF”) Issue No. 00-19, “Accounting for Derivative Instruments” (“EITF No. 00-19”), from the date the service/vesting period terminates through the expiration of the option or until it is exercised, whichever is earlier. Historically, the common stock options we have granted to non-employee consultants as compensation for services rendered were fully vested on the date of the grant and are therefore accounted for under EITF No. 00-19. In certain circumstances, these awards may have to be settled in cash. In addition, we are required to record a fair value adjustment at the end of each quarter for the change in the fair value of our fully-vested non-employee consultant stock options outstanding.
Our stock price may be volatile and may fluctuate. Since we cannot determine what our stock price will be at the end of future quarters, we cannot estimate the impact of EITF No. 00-19 on our consolidated balance sheet and Consolidated Statements of Operations in the future. An increase to our stock price as of the last day of a given quarter, as compared to our stock price as of the last day of the prior quarter, may result in an increase to the liability recorded to our consolidated balance sheet and an increase to operating expenses recorded on our Consolidated Statements of Operations. Conversely, a decrease to our stock price as of the last day of a given quarter, as compared to our stock price as of the last day of the prior quarter, may have the opposite effect. Additionally, any subsequent changes to the assumptions used in the Black-Scholes model to estimate the fair value of these non-employee consultant options will impact the effect of EITF No. 00-19 on our consolidated balance sheet and Consolidated Statements of Operations.
During the six months ended June 30, 2008, we exchanged in a tender offer options held by non-employee consultants to purchase 131,250 shares of our common stock, with a weighted average exercise price of $3.03, for 131,250 common shares. In connection
8
with this exchange, we incurred a non-cash charge of $170,082. The fair value of the non-employee consultant stock options was $245,835 and the value of the common stock issued was $415,917. The table below summarizes the changes in our derivative liability associated with non-employee consultant stock options for the period from December 31, 2007 through June 30, 2008.
| | | | |
Balance as of December 31, 2007 | | $ | 352,746 | |
Fair value of fully vested consultant stock options exchanged for common stock | | | (245,835 | ) |
Fair value adjustment as of June 30, 2008 | | | (72,164 | ) |
| | | | |
Balance as of June 30, 2008 | | $ | 34,747 | |
| | | | |
The fair value of our derivative liability associated with consultant stock options was estimated using the Black-Scholes option pricing model and was based on the closing price of our stock as quoted on Nasdaq on June 30, 2008, which was $2.05 per share, and the following weighted average assumptions as of June 30, 2008:
| | | |
Risk-free interest rate | | 2.9 | % |
Volatility | | 44 | % |
Dividend yield | | 0 | % |
Life | | 4 years | |
The weighted average fair value of the consultant stock options outstanding was $0.52 per share at June 30, 2008. The volatility of 44% represents the weighted average volatility based upon the weighted average remaining term of all outstanding consultant stock options.
As of June 30, 2008, our consultants held fully-vested stock options to purchase 66,263 shares of our common stock, at a weighted average exercise price of $3.37 per share and a weighted average remaining term of approximately 4 years. We have classified this liability as non-current as management does not believe that it will need to be satisfied using current assets within the next twelve months.
4. CASH, CASH EQUIVALENTS AND INVESTMENTS:
We invest excess cash in highly liquid investment-grade marketable securities including corporate debt securities and asset – backed securities. For financial reporting purposes, we consider all highly liquid investment instruments purchased with an original maturity of three months or less to be cash equivalents. Short-term investments are investment instruments purchased with an original maturity of greater than three months and less than one year. Long-term investments are investments purchased with an original maturity of greater than one year. Investments are considered available-for-sale and, accordingly, unrealized gains and losses are included as a separate component of shareholders’ equity. As of June 30, 2008 and December 31, 2007, cash, cash equivalents and investments consisted of the following:
| | | | | | | | | | | | | |
| | Gross Unrealized |
| | Amortized Cost | | Gains | | Losses | | | Fair Market Value |
June 30, 2008: | | | | | | | | | | | | | |
Cash and cash equivalents | | $ | 11,878,131 | | $ | — | | $ | — | | | $ | 11,878,131 |
Short-Term Investments: | | | | | | | | | | | | | |
Corporate debt securities | | | 11,739,539 | | | 23,586 | | | (7,427 | ) | | | 11,755,698 |
Government-sponsored enterprise debt | | | 7,271,950 | | | — | | | (7,789 | ) | | | 7,264,161 |
Asset-backed securities | | | 2,644,565 | | | 8,471 | | | — | | | | 2,653,036 |
| | | | | | | | | | | | | |
| | | 21,656,054 | | | 32,057 | | | (15,216 | ) | | | 21,672,895 |
Long-Term Investments: | | | | | | | | | | | | | |
Corporate debt securities | | | 2,524,464 | | | — | | | (18,234 | ) | | | 2,506,230 |
| | | | | | | | | | | | | |
Total | | $ | 36,058,649 | | $ | 32,057 | | $ | (33,450 | ) | | $ | 36,057,256 |
| | | | | | | | | | | | | |
December 31, 2007: | | | | | | | | | | | | | |
Cash and cash equivalents | | $ | 10,185,775 | | $ | — | | $ | — | | | $ | 10,185,775 |
Short-Term Investments: | | | | | | | | | | | | | |
Corporate debt securities | | | 25,357,929 | | | 41,367 | | | (7,677 | ) | | | 25,391,619 |
Asset-backed securities | | | 8,816,085 | | | 14,409 | | | — | | | | 8,830,494 |
Auction rate securities | | | 4,000,000 | | | — | | | — | | | | 4,000,000 |
| | | | | | | | | | | | | |
| | | 38,173,914 | | | 55,776 | | | (7,677 | ) | | | 38,222,113 |
| | | | | | | | | | | | | |
Total | | $ | 48,359,789 | | $ | 55,776 | | $ | (7,677 | ) | | $ | 48,407,888 |
| | | | | | | | | | | | | |
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Amortization of discounts and premiums related to investments resulted in income of $68,770 and $231,485 for the three and six months ended June 30, 2008, respectively, as compared to income of $163,348 and $263,128 for the three and six months ended June 30, 2007.
5. INVENTORIES:
As of June 30, 2008 and December 31, 2007, inventories consisted of the following:
| | | | | | |
| | June 30, 2008 | | December 31, 2007 |
Raw materials | | $ | 4,716,161 | | $ | 2,647,695 |
Work-in-process | | | 3,750,236 | | | 4,393,537 |
Finished goods | | | 8,598,119 | | | 8,570,537 |
| | | | | | |
| | $ | 17,064,516 | | $ | 15,611,769 |
| | | | | | |
6. REVENUE INTEREST OBLIGATION:
During October 2001, we completed a $10,000,000 product development and equity financing with Paul Capital Royalty Acquisition Fund, L.P., which was subsequently assigned to Royalty Securitization Trust I (“Royalty Trust”) and provided for the payment of revenue interest to Royalty Trust. The net proceeds from the financing were first allocated to the fair value of the common stock purchased on the date of the transaction (which was $4,777,893) as part of the financing, and the $5,222,107 remainder of the net proceeds was allocated to the revenue interest obligation in accordance with EITF Issue No. 88-18, “Sales of Future Revenues” (“EITF No. 88-18”). On March 22, 2002, we amended the original financing, which resulted in a one-time increase to the revenue interest obligation of $1,945,593, increasing the balance of the revenue interest obligation to $7,167,700. On July 30, 2007, we repurchased the revenue interest obligation from Royalty Trust. As a result, we are no longer obligated to pay royalties on our products subject to the revenue interest obligation, including VITOSS and CORTOSS. The repurchase price for the revenue interest obligation consisted of a payment of $20,000,000 in cash and 1,136,364 shares of our common stock valued at $3.32 per share, which was the market price per share on the date of the transaction. As a result of the repurchase, we recorded a charge of $16,605,029 in July 2007 to account for the difference between the repurchase price valued at $23,772,729 and the $7,167,700 carrying value of the revenue interest liability on our consolidated balance sheet as of the date of the transaction. In connection with the repurchase, Royalty Trust assigned to us all of its interest under the agreement relating to the revenue interest obligation, effectively terminating the security interest in certain of our assets and the pledge of stock of our wholly-owned subsidiary that we had granted Royalty Trust to secure our obligations under the revenue interest agreement.
Throughout the term of the Royalty Trust revenue interest agreement, we were required to make advance payments on the revenue interest obligation at the beginning of each year. In January 2006, we paid Royalty Trust the $1,750,000 advance payment for 2006. Of the $1,750,000, $1,179,466 was earned in 2006 and the balance of $570,534 was repaid to us in January 2007. As a result of our repurchase of the revenue interest from Royalty Trust on July 30, 2007, Royalty Trust returned to us $993,297 of the 2007 advance payment of $1,750,000.
The products that had been subject to the revenue interest agreement had been approved and launched at various times over the last several years or were still under development. For these reasons, as of and prior to July 29, 2007, we could not make a reasonable estimate of future revenues and payments that could have become due to Royalty Trust under this financing. Accordingly, we did not amortize any portion of the liability attributable to the revenue interest obligation, and we charged revenue interest expense in accordance with EITF No. 88-18 for the revenue interest due to Royalty Trust as revenues subject to the revenue interest obligation were recognized.
Revenue interest expense of $351,865 and $671,494 was recorded for the three and six months ended June 30, 2007, respectively.
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7. OTHER ACCRUED EXPENSES:
As of June 30, 2008 and December 31, 2007, other accrued expenses consisted of the following:
| | | | | | |
| | June 30, 2008 | | December 31, 2007 |
Commissions payable | | $ | 1,372,288 | | $ | 1,093,231 |
Accrued professional fees | | | 719,820 | | | 1,179,306 |
Interest payable | | | 625,000 | | | 625,000 |
Royalties payable | | | 457,391 | | | 352,704 |
Building improvements | | | 409,650 | | | 1,084,494 |
Other | | | 801,901 | | | 511,512 |
| | | | | | |
Total | | $ | 4,385,050 | | $ | 4,846,247 |
| | | | | | |
8. SHAREHOLDERS’ EQUITY:
The table below summarizes the changes in the shares of common stock outstanding and in total shareholders’ equity for the period from December 31, 2007 through June 30, 2008.
| | | | | | |
| | Shares | | Total Shareholders’ Equity | |
| |
Balance, December 31, 2007 | | 75,683,840 | | $ | 54,529,417 | |
Common stock purchased under the employee stock purchase plan | | 40,500 | | | 87,511 | |
Exchange of consultant stock options for common stock | | 131,250 | | | 415,917 | |
Stock-based employee compensation expense determined under SFAS No. 123R | | — | | | 455,632 | |
Compensation expense related to restricted stock awards and restricted stock units | | — | | | 177,740 | |
Changes in other comprehensive income | | — | | | 217,087 | |
Common stock issued for services rendered | | 6,700 | | | 20,971 | |
Net loss | | — | | | (7,834,995 | ) |
| | | | | | |
Balance, June 30, 2008 | | 75,862,290 | | $ | 48,069,280 | |
| | | | | | |
Equity Compensation Plan
We have an equity compensation plan (the “Plan”) that provides for incentive and nonqualified stock options, restricted stock awards, restricted stock units and other equity incentives to be granted to directors, employees, and consultants. The Plan has been approved by our shareholders.
Common Stock
During six months ended June 30, 2008, we issued 0 and 6,700 shares of common stock valued at $0 and $20,971, respectively, for consulting services rendered, pursuant to consultant services agreements.
During the three and six months ended June 30, 2007, we issued 2,667 and 3,791 shares of common stock valued at $7,734 and $11,410, respectively, for consulting services rendered, pursuant to consultant services agreements.
Restricted Stock and Restricted Stock Units
We did not issue any restricted common stock units to our employees during the three and six months ended June 30, 2008. During the six months ended June 30, 2007, we issued an aggregate of 318,332 restricted common stock units valued at $1,040,946 to certain employees. These units vest 50% on each of the second and fourth anniversaries of the date of issuance.
On June 26, 2007, we issued restricted common stock awards of an aggregate of 36,204 shares to our non-employee directors in consideration of their services. These shares were valued at $104,992 and vest generally on the fifth anniversary of grant or earlier upon a change of control of the Company or when a director no longer serves on our board of directors.
There was $538,177 of unrecognized cost related to unvested restricted stock and restricted stock units as of June 30, 2008 which is expected to be recognized over a weighted average period of approximately 1.25 years. The compensation expense recorded for these awards during the six months ended June 30, 2008 and 2007 was $177,740 and $141,672, respectively.
Common Stock Options
During the six months ended June 30, 2008, we issued under the Plan options to purchase 1,353,342 shares of common stock to our employees. The aggregate fair value of the grants was $2,306,299 and will be amortized over the four year vesting term.
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There were no stock options exercised during the three and six months ended June 30, 2008. During the three and six months ended June 30, 2007, stock options to purchase 10,000 and 74,625 shares of common stock were exercised for proceeds of $27,050 and $221,350, respectively.
Options are granted with exercise prices equal to or greater than the fair market value of the common stock on the date of grant. Generally, incentive stock options become exercisable in equal installments over a four-year period and nonqualified stock options to non-employee consultants are fully vested on the date of grant. The non-employee consultant options generally remain exercisable for a maximum period of ten years.
During the three and six months ended June 30, 2008, in accordance with SFAS No. 123R, we expensed $263,503 and $455,632, respectively, for employee stock options (see Note 2). During the three and six months June 30, 2007, in accordance with SFAS No. 123R, we expensed $126,807 and $420,882, respectively, for employee stock options.
There was $3,009,796 of unrecognized compensation cost related to unvested employee stock options as of June 30, 2008 which is expected to be recognized over a weighted average period of approximately 2.6 years.
As of June 30, 2008, there were 13,850,000 shares authorized for issuance under our Plan, of which grants with respect to 6,520,197 shares are outstanding, and grants with respect to 2,923,434 shares were available for issuance.
| | | |
| | Shares | |
Outstanding at December 31, 2007 | | 5,411,740 | |
Granted | | 1,353,342 | |
Exercised | | — | |
Cancelled and Expired | | (244,885 | ) |
| | | |
Outstanding at June 30, 2008 | | 6,520,197 | |
| | | |
Additional information regarding stock options as of June 30, 2008 is as follows:
| | |
Exercise Price Range | | Number of Options Outstanding |
$1.65 - $1.98 | | 11,500 |
2.02 - 2.49 | | 196,000 |
2.56 - 2.98 | | 1,505,407 |
3.00 - 3.25 | | 1,098,690 |
3.26 - 3.99 | | 1,963,217 |
4.00 - 4.25 | | 136,300 |
4.26 - 4.50 | | 1,214,408 |
4.51 - 4.99 | | 98,000 |
5.00 - 5.75 | | 255,375 |
5.90 - 11.25 | | 41,300 |
| | |
Total | | 6,520,197 |
| | |
Employee Stock Purchase Plan
During the three and six months ended June 30, 2008, employees purchased 23,439 and 40,500 shares of common stock under the Employee Stock Purchase Plan for proceeds of $45,712 and $87,511, respectively. During the three and six months ended June 30, 2007, employees purchased 10,076 and 21,094 shares of common stock under the Employee Stock Purchase Plan for proceeds of $28,720 and $59,237, respectively.
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Common Stock Purchase Warrants
Summary information regarding warrants to purchase common stock outstanding as of June 30, 2008 is as follows:
| | | | | | | | |
| | Number of Shares Underlying Outstanding Warrants | | | Exercise Price | | Expiration Date |
| | 104,000 | | | $ | 2.80 | | October 2008 |
| | 1,466,276 | (1) | | $ | 3.41 | | July 2012 |
Total | | 1,570,276 | | | | | | |
(1) | Warrants to purchase 733,138 shares of common stock are currently exercisable. See Note 11 and 14. |
No warrants were exercised during the six months ended June 30, 2008. Warrants to purchase 996,787 shares of common stock at an exercise price of $3.61 per share expired during the six months ended June 30, 2008. During the six months ended June 30, 2007, warrants to purchase 10,000 shares of common stock were exercised for gross proceeds of $17,500.
9. PRODUCT SALES:
For the three and six months ended June 30, 2008 and 2007, product sales by geographic market were as follows:
| | | | | | | | | | | | |
| | Three Months Ended June 30 | | Six Months Ended June 30 |
| | 2008 | | 2007 | | 2008 | | 2007 |
PRODUCT SALES | | | | | | | | | | | | |
United States | | $ | 17,672,312 | | $ | 13,749,083 | | $ | 32,726,279 | | $ | 25,965,319 |
Outside the United States | | | 1,668,402 | | | 1,102,860 | | | 2,778,717 | | | 2,037,310 |
| | | | | | | | | | | | |
Total | | $ | 19,340,714 | | $ | 14,851,943 | | $ | 35,504,996 | | $ | 28,002,629 |
| | | | | | | | | | | | |
Approximately 60% of our product sales during each of the three and six months ended June 30, 2008 were from products based upon our VITOSS FOAM platform co-developed with Kensey (see Note 10), as compared to 60% and 61% for the same respective periods in 2007. VITAGEL accounted for approximately 25% of product sales during the three and six months ended June 30, 2008, as compared to approximately 19% and 20% of product sales during each of the three and six months ended June 30, 2007, respectively.
There were no VITASURE product sales during the periods reported. We launched VITASURE Absorbable Hemostat in July 2008.
10. | COMMITMENTS AND CONTINGENCIES: |
Operating Leases
We lease office space under non-cancelable operating leases. In July 2008 we extended the term of our existing office space leases by a term of 60 months, until July 31, 2017. As of June 30, 2008, future minimum rental payments under operating leases are as follows:
| | | |
Remainder of 2008 | | $ | 396,654 |
2009 | | | 812,104 |
2010 | | | 838,278 |
2011 | | | 864,465 |
2012 | | | 901,244 |
2013 and thereafter | | | 4,320,309 |
| | | |
| | $ | 8,133,054 |
| | | |
Agreement with Kensey
In March 2003, we entered into an agreement with Kensey to jointly develop and commercialize certain biomaterials-based products based upon our VITOSS platform. The new products that may be developed under this agreement are based on our internally developed proprietary VITOSS bone void filler material in combination with proprietary resorbable Kensey biomaterials. Kensey has the exclusive right to manufacture any approved or cleared jointly developed product under the agreement, and we will market and sell the product worldwide. Following the regulatory approval or clearance of each new product under the agreement, we have obligations to pay Kensey for manufacturing the product and make royalty payments to Kensey based on the net sales of such product. These rights and obligations extend until at least February 2024 for our VITOSS Bioactive Foam product, and until February 2014 for our other products under the VITOSS FOAM product platform.
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During the six months ended June 30, 2008 and 2007, we purchased $3,859,988 and $4,206,758, respectively, of product inventory manufactured by Kensey on our behalf. As of June 30, 2008 and December 31, 2007, we owed Kensey $2,137,436 and $2,569,004, respectively, for manufactured product inventory and royalties, which are included in accounts payable and other accrued expenses on the consolidated balance sheets. All product royalty expense payable to Kensey is included in cost of sales on our Consolidated Statements of Operations as we recognize product sales revenue from our customers.
In addition, we pay royalties to Kensey on our VITOSS Bone Graft Substitute product sales, based on a royalty arrangement that Kensey purchased from the product’s co-inventor effective April 2004. Of the $5,000,000 in maximum aggregate royalties payable under the royalty arrangement, we have paid approximately $2,300,000 from inception of the arrangement through June 30, 2008.
Agreement with Allergan
In November 2007, we entered into a supply and license agreement to acquire raw material, equipment and a technology license from Allergan, Inc. and its affiliate Allergan Sales, LLC for an aggregate purchase price of approximately $6,600,000 in cash. We expect to close the transaction and make the purchase price payment in a lump sum during the second half of 2008. The raw material, equipment and license to be acquired from Allergan relate primarily to the production of our VITAGEL Surgical Hemostat product. Under the agreement, Allergan is obligated to manufacture and supply us with specified quantities of collagen, sell us certain collagen production and test equipment and grant us a non-exclusive, perpetual, royalty-free, irrevocable license to certain collagen production process technology and know how. Allergan has delivered the collagen raw material, know-how and equipment in part and we expect delivery to be completed during the fourth quarter of 2008. As of June 30, 2008, we have received approximately $746,000 of raw material and $466,000 of equipment relating to this agreement. Accordingly, these amounts are included in inventory, equipment, and accounts payable on our consolidated balance sheet as of June 30, 2008.
Agreement with Medafor
In April 2008, we obtained certain non-exclusive rights in the United States and in certain limited territories outside of the United States to distribute VITASURE™ Absorbable Hemostat pursuant to an agreement with Medafor. Under the agreement, if certain conditions are met, we must purchase at least $1,000,000 of VITASURE product from Medafor during each of the twelve month periods commencing in the third quarters of 2008 and 2009. We launched the VITASURE product in the third quarter of 2008.
11. | SENIOR SECURED NOTE PURCHASE FACILITY |
On July 30, 2007, we entered into a $45,000,000 senior secured note purchase facility with LB I Group Inc., an affiliate of Lehman Brothers Inc. Notes issued under the facility are due July 30, 2012. We initially issued $25,000,000 of our 10% senior secured notes due July 30, 2012 under the facility. The majority of the proceeds from the initial $25,000,000 principal amount note issuance was used to (i) pay to Royalty Trust the $20,000,000 cash portion of the revenue interest obligation repurchase price (see Note 6); and (ii) pay off approximately $2,000,000 of outstanding indebtedness under capital lease obligations and notes payable. As of June 30, 2008, we had the option through January 30, 2010 to issue under the debt facility up to an additional $20,000,000 aggregate principal amount of 10% senior secured notes due July 30, 2012 to fund working capital and other general business purposes, including product acquisitions, sales force expansion and product development, if certain conditions are met, including: (1) our consolidated net revenues for the most recently ended four consecutive quarterly periods are at least $45,000,000 and (2) we have not exercised our option to prepay any of the notes outstanding under the facility. See Note 14 (Subsequent Event) below for information regarding the issuance of an additional note under the facility during the third quarter of 2008.
Borrowings under the facility are guaranteed by us and one of our wholly-owned subsidiaries. The facility is secured by a first priority lien on substantially all of our assets (including intellectual property) other than those exclusively related to CORTOSS and ALIQUOT. We are required to make quarterly interest only payments to the note holder. Upon the occurrence of various events, including our receipt of (i) proceeds in excess of 5% of our total assets for certain asset dispositions; (ii) more than $1,000,000 in aggregate cash insurance proceeds for damaged or destroyed property that is not applied to the repair or replacement of the property within one year; or (iii) more than $7,500,000 in gross cash proceeds from judgment awards or settlements, the note holders are entitled to prepayment of the outstanding principal amount of the notes to the extent of the net cash proceeds that we receive. We may prepay at any time any part of the outstanding balance under the notes, in a minimum amount of $2,000,000 and in increments of at least $1,000,000 in excess of such minimum, together with interest accrued thereon. Both mandatory and optional prepayments are subject to a prepayment premium of up to 16% of the outstanding principal balance of the notes then outstanding, depending on the timing of the prepayment. The unpaid principal amount under the notes and accrued interest and all other obligations shall become due and payable immediately if we are insolvent, are in bankruptcy proceedings or have a custodian or receiver appointed for any substantial part of our property. If an event of default not described in the preceding sentence occurs and is continuing (including a
14
change of control of the Company), then the holders of at least two-thirds in principal amount of notes then outstanding may declare the unpaid principal amount of the notes, accrued interest and all other obligations due and payable immediately. In addition, if the notes become due and payable, whether automatically or by declaration, by reason of any of the following events of default, then we must pay a prepayment premium of up to 16% of the outstanding principal balance of the notes then outstanding, depending on the timing of the prepayment:
| • | | We fail to pay any principal on any note or prepayment premiums, if any, when due and payable; |
| • | | We fail to pay any interest on any note or other amount (other than principal or prepayment premiums) for more than three business days after becoming due and payable; |
| • | | We are insolvent, in bankruptcy proceedings or have a custodian or receiver appointed for any substantial part of our property; or |
| • | | A change of control of the Company occurs, which is defined as (i) any person becoming a beneficial owner, directly or indirectly, of Company securities representing more than 50% of the voting power of the then outstanding securities of the Company (excluding transactions in which the Company becomes a subsidiary of another corporation and in which the Company’s shareholders immediately prior to the transaction will beneficially own, immediately after the transaction, shares entitling the shareholders to more than 50% of all votes to which all shareholders of the parent corporation would be entitled in the election of directors); (ii) the consummation of a merger or consolidation of the Company with another corporation where the Company’s shareholders immediately prior to the transaction will not beneficially own, immediately after the transaction, shares entitling the shareholders to more than 50% of all votes to which all shareholders of the surviving corporation would be entitled in the election of directors; (iii) the consummation of a sale or other disposition of all or substantially all of the Company’s assets; (iv) a liquidation or dissolution of the Company; or (v) individuals who, as of July 30, 2007, constituted the Company’s board of directors (the “Incumbent Directors”) ceasing for any reason to constitute at least a majority of the board; provided that any person becoming a director subsequent to July 30, 2007 and whose election or nomination for election to the board was approved by a vote of at least a majority of the Incumbent Directors who are directors at the time of such vote shall be deemed an Incumbent Director. |
Under the facility, we must comply with various financial and non-financial covenants. Under the financial covenant, we are required to maintain a minimum cash balance equal to at least 25% of the then outstanding principal amount under the notes in a separate interest-bearing deposit or other similar demand investment account that is pledged as collateral for the loan. As of June 30, 2008, we must maintain a minimum cash balance of $6,250,000. If the balance in the separate account falls below an amount equal to 40% of the principal amount outstanding under the notes, we must obtain and maintain for the benefit of favor of the note holders a letter of credit in the amount of 25% of the principal amount outstanding under the notes. As of June 30, 2008, we must maintain a minimum balance of $10,000,000 in order to avoid obtaining a letter of credit, and we are not currently required to obtain a letter of credit. The primary non-financial covenants limit our ability to incur indebtedness or liens, sell assets, conduct mergers or acquisitions, make investments and pay dividends.
Outstanding principal amounts under the notes bear annual interest at 10%, provided that interest shall accrue at the rate of 12% per year during the continuance of any event of default and shall be payable on demand.
In connection with entering into the facility, we issued to the note purchaser five-year warrants to purchase 1,466,276 shares of our common stock at an exercise price of $3.41 per share, of which warrants to purchase 733,138 shares were exercisable as of June 30, 2008. The unexercisable warrants shall become exercisable ratably upon future issuances of the 10% senior secured notes under the facility. The fair value of $1,206,460 of the warrants exercisable as of June 30, 2008 was determined using the Black-Scholes option-pricing model and was recorded on our consolidated balance sheet at inception as a discount to the initial loan amount of $25,000,000 and is being amortized into interest expense over the five-year term of the facility. At June 30, 2008 and December 31, 2007, the unamortized debt discount to the loan amount related to the warrants totaled $983,979 and $1,104,624, respectively. The carrying value of the note on our consolidated balance sheet was $24,016,022 and $23,895,376 as of June 30, 2008 and December 31, 2007, respectively.
As of June 30, 2008, we had $25,000,000 outstanding under the facility, and had accrued approximately $625,000 in interest thereon.
12. AGREEMENTS WITH ANGIOTECH
In June 2004, we entered into a Distribution Agreement with Angiotech to distribute to surgical customers throughout North America the CoStasis® composite liquid hemostat (which we re-branded as VITAGEL Surgical Hemostat) and the CELLPAKER® plasma collection system used in conjunction with VITAGEL. The Distribution Agreement required us to purchase the products and make royalty payments to Angiotech based on the net sales of such products. Effective September 30, 2005, the Distribution Agreement was amended to provide for the transition of product and accessory manufacturing responsibility from Angiotech to us. The amendment also changed the royalty rate payable by us to Angiotech and modified the method for calculating net sales of such products.
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Angiotech decided to cease the manufacture of VITAGEL and CELLPAKER by November 2005; therefore, in October 2005, we purchased all available existing VITAGEL and CELLPAKER products, accessories and work-in-process from Angiotech for $1,800,000. On June 16, 2006, we obtained pre-market approval (“PMA”) from the FDA to sell VITAGEL manufactured at our Malvern, Pennsylvania facility (the “VITAGEL PMA”). After receiving the VITAGEL PMA, we started manufacturing VITAGEL in July 2006, and in August 2006 we commenced selling VITAGEL first manufactured since obtaining the VITAGEL PMA. In addition, we had previously manufactured under the VITAGEL PMA three lots of VITAGEL that became available for sale in late June 2006. In January 2007, we obtained approval from the FDA for a PMA supplement which enables us to sell CELLPAKER manufactured by our subcontractor’s facility. Effective January 1, 2006, we entered into a License Agreement with Angiotech pursuant to which Angiotech licensed VITAGEL products and the CELLPAKER plasma collection system to us and we assumed manufacturing responsibility for these products. The Distribution Agreement described above served as the basis for the establishment of the License Agreement. In accordance with its terms, the Distribution Agreement terminated in the first quarter of 2007 upon completion of the sale of all VITAGEL and CELLPAKER inventory products that we purchased from Angiotech in October 2005.
On December 29, 2006, pursuant to a Royalty Sale Agreement with Angiotech, we purchased the profit-sharing royalty rights for VITAGEL and CELLPAKER products under the License Agreement for $9,000,000 in cash. Concurrently with such purchase, we entered into an Amended and Restated License Agreement with Angiotech that amended the original License Agreement to eliminate our obligations to meet minimum sales requirements, extend the term of the license from December 31, 2014 through July 31, 2017, and eliminate certain termination rights in favor of Angiotech. Under the Amended and Restated License Agreement, we have exclusive rights to manufacture and sell VITAGEL products throughout the world for orthopedic indications, and non-exclusive rights to manufacture and sell CELLPAKER products throughout the world for all indications. Under the Amended and Restated License Agreement, Angiotech has an option for co-exclusive rights outside the orthopedic field which, if exercised, would permit Angiotech to manufacture and sell an Angiotech-branded VITAGEL product throughout the world. Until Angiotech elects to exercise its option for co-exclusive rights, we have exclusive rights to manufacture and sell VITAGEL outside of the orthopedic field throughout the world. If Angiotech elects to exercise its option, we would then have co-exclusive rights to manufacture and sell VITAGEL outside of the orthopedic field throughout the world. Prior to the amendment and restatement of the License Agreement on December 29, 2006, we were required to make royalty payments thereunder based on a share of all revenue we received from net sales of VITAGEL and CELLPAKER products that we manufactured. The $9,000,000 payment has been recorded as a License Right Intangible on the accompanying consolidated balance sheets as of June 30, 2008 and December 31, 2007. This amount is being amortized based upon the greater of (a) straight-line amortization through July 31, 2017, or (b) actual units sold in a given period in relation to the total estimated units to be sold over the expected life of the applicable patent, which is July 31, 2017. For the three and six months ended June 30, 2008 and 2007, this amount was amortized on a straight-line basis. Amortization expense of $212,598 and $425,196 was recorded in Cost of Sales on the accompanying Consolidated Statement of Operations for the three and six months ended June 30, 2008 and 2007, respectively.
13. SALE OF PRODUCT LINE AND RELATED ASSETS:
On February 15, 2007, we sold our assets associated with the ENDOSKELETON TA Vertebral Body Replacement structural device product line for $458,480, of which we recorded $372,375 as a gain on sale of assets during the six months ended June 30, 2007. As a result of the sale, we no longer manufacture or sell ENDOSKELETON products. We had no revenues related to the ENDOSKELETON products during the six months ended June 30, 2008 and 2007.
14. SUBSEQUENT EVENT
On July 31, 2008, we issued an additional 10% senior secured note in the principal amount of $10,000,000 under our debt facility with LB I Group Inc. We plan to apply the proceeds of this note toward payment of (i) the $6,600,000 purchase price for the collagen raw material, equipment and technology license to be acquired under our supply and license agreement with Allergan; and (ii) costs to expand our manufacturing capacity for VITAGEL and ancillary products such as ALIQUOT, IMBIBE and CELLPAKER. As a result of our issuance of the $10,000,000 note on July 31, 2008, warrants to purchase 366,569 shares of our common stock at an exercise price of $3.41 per share became exercisable. The fair value of the warrants that become exercisable as of July 31, 2008 is approximately $416,000 and was determined using the Black-Scholes option-pricing model. This discount will be amortized into interest expense over the remaining four-year term of the facility. These warrants were previously issued upon entering into the debt facility with LB I Group Inc. in July 2007. See Note 11 for additional information regarding the terms of our debt facility and notes issued thereunder.
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ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Forward-Looking Statements
Forward-looking statements give our current expectations, forecasts of future events or goals. You can identify these statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “may,” “will,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “seek” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Any or all of our forward-looking statements in this Form 10-Q may turn out to be wrong. They can be affected by inaccurate assumptions we might make, or by known or unknown risks and uncertainties. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially. There are important factors that could cause actual events or results to differ materially from those expressed or implied by forward-looking statements including, without limitation, the development, regulatory approval, demand and market acceptance of our products; results of our CORTOSS pivotal clinical trial in the U.S.; the amount and sufficiency of data that the FDA will require for our CORTOSS 510(k) application; the cost to expand our manufacturing and operating facilities; our need to borrow under our debt facility; the development of our sales network; capital expenditures; future liquidity; uses of cash; sales product mix and related margins; our ability to manage our manufacturing facilities and requirements; availability of raw materials; inventory levels; development costs for existing and new products; our ability to successfully launch the VITOSS Bioactive FOAM and VITASURE Absorbable Hemostat products; equity compensation expense; changes in market interest and foreign currency exchange rates; fluctuations in our stock price; and the other risk factors addressed in ITEM 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the U.S. Securities and Exchange Commission (the “SEC”). We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our filings with the SEC. This discussion is provided as permitted by the Private Securities Litigation Reform Act of 1995.
OVERVIEW
Product sales for the three and six months ended June 30, 2008 increased 30% and 27% to $19,340,714 and $35,504,996, respectively, as compared to $14,851,943 and $28,002,629 for the same periods in 2007. Increased product sales principally reflect increased sales of our VITOSS® FOAM and VITAGEL® products in the U.S. We anticipate our product sales for the foreseeable future will remain insufficient to support our operations at expected spending levels. We expect to continue to incur significant operating losses for the foreseeable future as we plan to continue to expand our sales and marketing activities, pursue product development efforts, further develop our manufacturing capabilities and attempt to increase manufacturing efficiencies.
The following summarizes our principal cash and operating commitments at June 30, 2008 and as of the date of this report:
| • | | Agreement with Kensey.Approximately 60% of our product sales during each of the three and six months ended June 30, 2008 were from products based upon our VITOSS FOAM platform co-developed with Kensey, as compared to 60% and 61% for the same periods in 2007. As of June 30, 2008, we owed Kensey $2,137,436 for manufactured product inventory and royalties, which amount is included in accounts payable and other accrued expenses on the consolidated balance sheets. See Note 10 to our consolidated interim financial statements included in this report for additional information. |
| • | | Operations – We expect to use cash, cash equivalents and investments to fund our operations until we generate sufficient cash to support our operations, if ever. See Note 10 to our consolidated interim financial statements included in this report for additional information on future minimum rental payments under operating leases. In addition, we may hire additional direct sales representatives to support not only the growth of our existing products, but to plan ahead for the possible clearance and commercial launch of CORTOSS in the U.S. While we believe that our investment in our sales force may also bring opportunities to in-license or distribute additional products, we expect to continue spending for research and development for new products. |
| • | | Allergan Agreement – In November 2007, we entered into a supply and license agreement to acquire collagen raw material, equipment and a technology license from Allergan, Inc. and its affiliate Allergan Sales, LLC for an aggregate purchase price of approximately $6,600,000 in cash. We expect to complete the acquisition of these assets and make the purchase price payment in a lump sum in the second half of 2008 from cash, cash equivalents, and investments and proceeds from the $10,000,000 note we issued in July 2008 under our debt facility with LB I Group Inc. See Notes 11 and 14 to our consolidated interim financial statements included in this report for additional information regarding the terms of our debt facility and borrowings thereunder. |
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| • | | Expansion of manufacturing capacity – We expect to spend approximately $7,000,000, with commitments outstanding for $6,200,000 as of June 30, 2008, for plant expansion and equipment during the remainder of 2008 to expand our capacity to manufacture VITAGEL and ancillary products such as ALIQUOT, IMBIBE and CELLPAKER, at sites we currently lease. We plan to finance the expansion and equipment through cash, cash equivalents and investments and proceeds from the $10,000,000 note we issued under our debt facility with LB I Group Inc in July 2008. |
| • | | CORTOSS clinical study and 510(k) application - We expect to incur approximately $1,400,000 in external costs during the remainder of 2008 and into 2009 for the CORTOSS pivotal clinical study in the U.S. Since the completion of patient enrollment for the study in February 2007 and the filing of our CORTOSS 510(k) application with the FDA in January 2008, we have been monitoring and will continue to monitor the patients in the study in order to collect, consolidate and analyze clinical data to support our CORTOSS 510(k) filing. In response to comments received by the FDA during the end of the first quarter of 2008 to our 510(k) submission for CORTOSS, we expect to submit to the FDA in the third quarter of 2008 additional clinical and pre-clinical data, which will include further two-year follow-up patient data. We may also be required to submit additional two-year follow-up patient data and other data thereafter. |
| • | | Medafor Agreement- We expect to spend $1,000,000 during each of the twelve month periods commencing in the third quarter of 2008 and 2009 to purchase VITASURE Absorbable Hemostat product inventory under our distribution agreement with Medafor. See Note 10 to our consolidated interim financial statements included in this report for additional information. |
| • | | Debt service obligation.We expect to pay approximately $792,000 and $875,000 in quarterly interest payments during the third and fourth quarters of 2008, respectively, under the $35,000,000 aggregate principal amount of notes issued under our debt facility with LB I Group Inc. |
Our existing cash, cash equivalents, and investments as of June 30, 2008 were $36,057,256. We believe our current cash, cash equivalents, and investments, together with the remaining amounts available to us under our debt facility, will be sufficient to meet our currently estimated operating and investing requirements for the foreseeable future. In addition, we received $10,000,000 in proceeds from the issuance of a note in July 2008 under our debt facility and, if certain conditions are met, we have the capacity to borrow up to an additional $10,000,000 under the terms of the facility. See Notes 11 and 14 to our consolidated interim financial statements included in this report for additional information regarding the terms of our debt facility.
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CRITICAL ACCOUNTING POLICIES
The preparation of the consolidated interim financial statements requires us to make assumptions, estimates and judgments that affect the reported amounts of assets and liabilities, the disclosures of contingent assets and liabilities as of the date of the consolidated interim financial statements, and the reported amounts of revenues and expenses during the reporting periods. By their nature, these assumptions, estimates and judgments are subject to an inherent degree of uncertainty. We use authoritative pronouncements, historical experience and other assumptions as the basis for making estimates. Actual results could differ from those estimates. We have addressed our critical accounting policies in ITEM 7 of our Annual Report on Form 10-K for the year ended December 31, 2007 under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies.” The following discussion supplements the discussion of critical accounting policies contained in our Form 10-K. The critical accounting policies addressed below, together with those described in our Form 10-K, have been reviewed with the Audit Committee and reflect our most significant judgments and estimates used in the preparation of our consolidated interim financial statements.
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. With the exception of the Texas Margin Credit described below, management believes it is more likely than not that we will not realize the deferred tax assets in excess of deferred tax liabilities. A valuation allowance is maintained against the net deferred tax assets in excess of the Texas Margin Credit.
On May 18, 2006, the Governor of the State of Texas signed into law a Texas margin tax which restructures the state business tax by replacing the taxable capital components of the current franchise tax with a new“taxable margin” component. The Texas margin tax was effective for taxable years ended on or after January 1, 2007. As a result of the Texas margin tax we recognized current state income tax expense of $28,700 for the six months ended June 30, 2008. Under the Texas Margin Tax enacted statute, we have the right to claim a temporary credit against our Texas Margin Tax liability over a 20 year period. As a result, we have reduced the deferred tax asset from $302,980 as of December 31, 2007 to $299,493 on our consolidated balance sheet as of June 30, 2008.
Liquidity and Capital Resources
We have experienced negative operating cash flows since our inception and we have funded our operations primarily from the proceeds received from sales of our stock. Cash, cash equivalents and investments were $36,057,256 and $48,407,888 at June 30, 2008 and December 31, 2007, respectively. We believe our current cash, cash equivalents, and investments, together with the remaining amounts available to us under our debt facility, will be sufficient to meet our currently estimated operating and investing requirements for the foreseeable future. In addition, we received $10,000,000 in proceeds from the issuance of a note in July 2008 under our debt facility and, if certain conditions are met, we have the capacity to borrow up to an additional $10,000,000 under the terms of the facility. See Notes 11 and 14 to our consolidated interim financial statements included in this report for additional information regarding the terms of our debt facility.
Discussion of Cash Flows
Cash Flows Used in Operating Activities
Net cash used in operating activities for the six months ended June 30, 2008 was $10,463,612, as compared to $8,782,011 for the same period in 2007. Our operating cash outflows for the six months ended June 30, 2008 primarily were used to fund our operations and include $1,451,588 for an increase in accounts receivable related to increased sales, $1,452,747 used to fund increases in inventories as well as funding for the expansion of our field sales team and sales commissions on our growing product sales. In addition, decreases in accounts payable of $721,143 and accrued expenses of $877,208 were a use of operating cash flows in the six months ended June 30, 2008.
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We expect to continue to focus our efforts on sales growth under our VITOSS and VITAGEL product platforms in 2008, and launched VITOSS Bioactive FOAM in the first quarter of 2008. We may continue to add direct sales representatives to our organization for those territories in the U.S. where either we do not currently have independent distributor coverage or the territory is underserved in an effort to increase sales of our VITOSS and VITAGEL product lines and to plan ahead for the possible clearance of CORTOSS in the United States. Also, we intend to fund studies to collect and publish post-clinical data relating to the performance of VITOSS to support our marketing and sales efforts.
We expect to continue to use cash, cash equivalents and investment proceeds to fund our operations until we are profitable, if ever. We anticipate that our product sales for the foreseeable future will remain insufficient to support our present operations at expected spending levels. As a result, we expect to continue to incur significant operating losses for the foreseeable future as we continue to expand our sales and marketing activities, pursue product development efforts and further develop our manufacturing capabilities.
We expect our primary use of cash for external research and development costs in 2008 to be directed to CORTOSS. During 2008 and 2009, we expect to incur approximately $1,400,000 in external costs to complete our pivotal clinical study in the U.S. for CORTOSS. The overall level of our research and development expense in future periods will depend upon the development status and cost of products currently in our pipeline and any new products that we may determine to pursue in the future. We may also incur additional expenses to support the U.S. launch of CORTOSS if it receives FDA clearance.
Our operating cash requirements are dependent heavily upon the timing of receipt of FDA 510(k) clearance for new products, the rates at which we add new direct sales representatives and our field sales network generates sales, our product sales mix as relative increases in sales of our lower margin products tend to increase our cash needs, the amount of inventory, including raw materials and work-in-process, we maintain to support product sales and anticipated product launches, the timing of subsequent product launches and market acceptance of our new products. Accordingly, in 2008, our operating cash requirements will continue to be subject to quarterly volatility.
We also expect to use cash, cash equivalents and investments to purchase at least $1,000,000 of VITASURE product during each of the twelve month periods commencing in the third quarters of 2008 and 2009 in accordance with our distribution agreement with Medafor. We launched the VITASURE product in the third quarter of 2008.
Cash Flows Provided by Investing Activities
Net cash provided by investing activities was $11,811,737 for the six months ended June 30, 2008 compared to $1,411,852 for the six months ended June 30, 2007. The increase in cash provided by investing activities for the six months ended June 30, 2008 primarily reflects the proceeds from the sale and maturity of investments of $34,974,053, partially offset by the purchases of new investments of $20,749,070, to fund our operating activities. In addition, we spent $2,413,246, including $211,889 in capitalized interest, during the six months ended June 30, 2008 to purchase equipment and leasehold improvements to support further expansion of our product development and manufacturing capabilities for VITAGEL and VITOSS, as compared to $484,258 spent during the six months ended June 30, 2007 for equipment and leasehold improvements.
We invest our excess cash in highly liquid investment-grade marketable securities, including corporate debt securities and asset – backed securities.
We expect to spend approximately $7,000,000 during 2008 to expand our manufacturing facility and for related leasehold improvements and capital equipment. In addition, we are committed contractually to spend approximately $6,600,000, expected to be incurred in 2008, to acquire a technology license related to collagen processing for our VITAGEL product and to purchase related equipment from Allergan. See Note 10 to our consolidated interim financial statements included in this report. We plan to fund these amounts through the use of cash equivalents and investments and from the proceeds of our issuance in July 2008 of an additional $10,000,000 note under our debt facility with LB I Group Inc.
Cash Flows Provided by Financing Activities
Net cash provided by financing activities for the six months ended June 30, 2008 was $87,511 compared to net cash used of $149,506 for the six months ended June 30, 2007.
We do not expect sales to generate cash flows in excess of operating expenses for the foreseeable future, if ever. Until we achieve sales levels to enable us to fund operating expenses, we expect to continue to use cash, cash equivalents and investment proceeds to fund operating and investing activities. As of June 30, 2008, we had cash, cash equivalents and investments of $36,057,256, and we had up to $20,000,000 available for additional borrowing under our debt facility with LB I Group Inc. We believe our existing cash, cash equivalents and investments, together with $10,000,000 borrowed in July 2008 and the remaining $10,000,000 available to us under our debt facility, will be sufficient to meet our currently estimated operating and investing requirements for the foreseeable future. The extent and timing of proceeds from future stock option and warrant exercises, if any, are primarily dependent upon future trading prices for our common stock and the expiration dates of these instruments.
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Contractual Obligation and Commercial Commitments
See the “Overview” section under MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
We lease office space and equipment under non-cancelable operating leases. We entered into two leases in January 2008 for space located in the Great Valley Corporate Center in Malvern, Pennsylvania. One lease is for approximately 30,900 square feet of unfinished space for a new warehouse. The initial term of this lease is 55 months commencing January 1, 2008, and the initial annual base rent under the lease is approximately $216,125. The other lease is for approximately 4,800 square feet of additional office and laboratory space. The initial term of this lease is 55 months commencing January 1, 2008, and the initial annual base rent under the lease is approximately $43,593. We completed renovations for both the warehouse and the office/laboratory space in April 2008. In July 2008 we extended the term of our existing office space leases by a term of 60 months, until July 31, 2017. As of June 30, 2008, future minimum rental payments under operating leases, which include the additional office space leases described above, are as follows:
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Remainder of 2008 | | | 396,654 |
2009 | | | 812,104 |
2010 | | | 838,278 |
2011 | | | 864,465 |
2012 | | | 901,244 |
2013 and thereafter | | | 4,320,309 |
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| | $ | 8,133,054 |
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Results of Operations
This section should be read in conjunction with the more detailed discussion under “Liquidity and Capital Resources.” As described therein, we expect to continue to incur significant operating losses in the foreseeable future as we continue our product development and sales efforts.
Product Sales.Product sales for each of the three and six months ended June 30, 2008 increased 30% and 27% to $19,340,714 and $35,504,996, respectively, as compared to $14,851,943 and $28,002,629 for the same periods in 2007. Sales growth was primarily attributable to increased sales of VITOSS FOAM and VITAGEL product portfolios in the U.S. as we further develop our U.S. field sales network. Approximately 60% of our product sales during the three and six months ended June 30, 2008 were from products based upon our VITOSS FOAM platform co-developed with Kensey (see Note 10 to our consolidated interim financial statements included in this report for additional information), as compared to 60% and 61% for the same periods in 2007. VITAGEL accounted for approximately 25% of product sales for the three and six months ended June 30, 2008 as compared to 19% and 20% for the same periods in 2007. For the three and six months ended June 30, 2008, 91% and 92% of product sales, respectively, were in the U.S., primarily from sales of VITOSS, VITAGEL and IMBIBE, as compared to 93% for each of the same periods in 2007. The remaining sales, during both periods in 2008 and 2007, were primarily the result of VITOSS, CORTOSS and ALIQUOT sales outside the U.S.
Gross Profit. The gross profit for the three and six months ended June 30, 2008 was $12,984,807 and $23,336,880, respectively, as compared to $9,778,830 and $18,220,427 for the same periods in 2007. As a percentage of sales, gross profit was 67% and 66% for the three and six months ended June 30, 2008, respectively, as compared to 66% and 65% for the same periods in 2007. The increase in the gross profit margin for the three and six months ended June 30, 2008, as compared to the gross profit margins for the corresponding periods in 2007, reflects improved manufacturing efficiencies and lower VITAGEL royalty expense as a percentage of product sales. Our gross margins may fluctuate from quarter to quarter based on the mix of products sold from period to period.
Operating Expenses.Operating expenses for the three months ended June 30, 2008 and 2007 were $16,275,624 and $12,787,589, respectively, which represents a 27% increase in operating expenses as compared to a 30% increase in product sales and a 33% increase in gross profit for the quarter. Operating expenses for the six months ended June 30, 2008 and 2007 were $30,646,013 and $24,446,454, respectively, which represents a 25% increase in operating expenses as compared to a 27% increase in product sales and a 28% increase in gross profit for the six month period. For the three months ended June 30, 2008, operating expenses were reduced by a non-cash fair value adjustment of $19,301, and increased by net non-cash charge of $111,895 for the six months ended June 30, 2008 for the exchange of non-employee consultant stock options for shares of our common stock pursuant to a tender offer, net of fair value adjustments for our fully-vested non-employee consultant stock options. For the three and six months ended June 30, 2007, operating expenses were reduced by non-cash fair value adjustments of $155,428 and $647,953, respectively, for our fully-vested non-employee consultant stock options outstanding.
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General & administrative expenses for the three months ended June 30, 2008 increased 8% to $3,072,327 from $2,836,696 for the same period of 2007. General & administrative expenses for the six months ended June 30, 2008 increased 4% to $5,530,732 from $5,308,103 for the same period of 2007. The increase in general & administrative expenses for the three and six months ended June 30, 2008, as compared to the corresponding period in 2007, was primarily due to legal and consulting costs. General & administrative expenses were equivalent to 16% of product sales for each of the three and six month periods ended June 30, 2008 and 19% of product sales for the same periods in 2007.
Selling & marketing expenses were $11,070,617 and $21,278,992 for the three and six months ended June 30, 2008, respectively, a 33% and 35% increase from $8,312,483 and $15,726,623 for the three and six months ended June 30, 2007. The increase for the three and six months ended June 30, 2008 was primarily due to higher salary and benefit costs incurred by expanding our field sales team in order to support the growth of U.S product sales, as well as higher commissions paid in the U.S. as a result of increased product sales in the three and six months ended June 30, 2008. The number of our direct sales representatives increased from 80 at June 30, 2007 to 92 at June 30, 2008. Selling & marketing expenses for the three months ended June 30, 2008 were reduced by a non-cash fair value adjustment of $19,301 and increased by net non-cash charge of $97,917 for the six months ended June 30, 2008 for the exchange of non-employee consultant stock options for shares of our common stock pursuant to a tender offer, net of fair value adjustments for our fully-vested non-employee consultant stock options. Selling & marketing expenses for the three and six months ended June 30, 2007 were reduced by non-cash fair value adjustments of $154,582 and $647,107, respectively, for our fully-vested non-employee consultant stock options outstanding. Amounts for selling & marketing expenses were equivalent to 57% and 56% of product sales for the three months ended June 30, 2008 and 2007, respectively. Amounts for selling & marketing expenses were equivalent to 60% and 56% of product sales for the six months ended June 30, 2008 and 2007, respectively.
Research & development expenses increased to $2,132,680 and $3,836,289 for the three and six months ended June 30, 2008, respectively, from $1,638,410 and $3,411,728 for the same periods in 2007. The increase for each of the three and six months ended June 30, 2008 is primarily due to increased product development activity and higher costs associated with the CORTOSS 510(k) application in the U.S. Research & development expenses were equivalent to 11% of product sales for the three months ended June 30, 2008 and 2007. Research & development expenses were equivalent to 11% and 12% of product sales for the six months ended June 30, 2008 and 2007, respectively.
Net other income (expense).Net other income (expense) included interest income, interest expense, and loss on asset disposals. We recorded $317,459 and $497,162 of net other expense for the three and six months ended June 30, 2008. Net other expense was $161,262 and net other income was $111,638 for the three and six months ended June 30, 2007 and included a gain on a sale of a product line, interest income, interest expense and revenue interest expense. The increase in net other expense for the three and six month periods is primarily a result of increased interest expense incurred under our debt facility in 2008, partially offset by a gain on sale of product line that occurred in February 2007.
ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Foreign Currency Risk
The functional currency for our European branch operation is the Euro. Accordingly, in accordance with SFAS No. 52 “Foreign Currency Translation,” all assets and liabilities related to this operation are translated at the current exchange rates at the end of each period. Revenues and expenses are translated at average exchange rates in effect during the period. The resulting translation adjustments are accumulated in a separate component of shareholders’ equity (accumulated other comprehensive income). Foreign currency transaction gains and losses, if any, are included in results of operations.
As of June 30, 2008 and December 31, 2007, our total exposure to foreign currency risk in U.S. dollar terms was approximately $5,500,000, and $3,630,000, or 6.7% and 4% of our total assets, respectively. The potential impact of a hypothetical 10% decline in the Euro foreign exchange rate would result in a total decline in the fair value of our assets of approximately $550,000 at June 30, 2008 and $363,000 at December 31, 2007.
Market Risk
We may be exposed to market risk through changes in market interest rates that could affect the value of our investments; however, we do not believe the fair value of our investment portfolio or related income would be significantly affected by changes in interest rates due mainly to the relatively short-term nature of the majority of our investment portfolio.
As of June 30, 2008 and December 31, 2007, our investments consisted of highly liquid investment-grade marketable securities including corporate debt securities and asset – backed securities. The impact on our future interest income and future changes in investment yields will depend on the gross amount of our investments and various external economic factors.
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ITEM 4. | CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of June 30, 2008 are functioning effectively to provide reasonable assurance that the information required to be disclosed by us in reports filed under the Securities Exchange Act of 1934 is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including the Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Withdrawal of Complaint: On June 24, 2008, Mo-Sci Corporation (Mo-Sci) withdrew without prejudice the complaint it had filed against us on March 4, 2008 in the United States District Court for the Eastern District of Pennsylvania. We had reported the filing of the complaint in our Annual Report on Form 10-K for the year ended December 31, 2007. We have asserted counterclaims and third-party claims against Mo-Sci and Dr. Erik Erbe, an individual we believe had served as a consultant to Mo-Sci and who is our former employee. With these counterclaims and third-party claims, we are seeking compensatory, special and punitive damages, attorneys’ fees and costs. In the counterclaim, we allege abuse of process, promissory estoppel, tortious interference with contract and fraud by Mo-Sci. In the third-party claim, we allege tortious interference with prospective contractual relations by Dr. Erbe. In addition, we charge Mo-Sci and Dr. Erbe with conspiracy.
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Exhibit 10.1 | | Employee Stock Purchase Plan of the Company |
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Exhibit 31.1 | | Certifications of the Chief Executive Officer Pursuant to Rule 13a – 14(a) and Rule 15d – 14(a) of the Securities Exchange Act of 1934, as amended |
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Exhibit 31.2 | | Certifications of the Chief Financial Officer Pursuant to Rule 13a – 14(a) and Rule 15d – 14(a) of the Securities Exchange Act of 1934, as amended |
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Exhibit 32.1 | | Certification of the Chief Executive Officer Pursuant to Rule 13a – 14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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Exhibit 32.2 | | Certification of the Chief Financial Officer Pursuant to Rule 13a – 14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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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.
| | | | |
| | ORTHOVITA, INC. |
| | (Registrant) |
| | |
August 8, 2008 | | By: | | /s/ ANTONY KOBLISH |
| | | | Antony Koblish |
| | | | Chief Executive Officer and President |
| | | | (Principal executive officer) |
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August 8, 2008 | | By: | | /s/ ALBERT J. PAVUCEK, JR. |
| | | | Albert J. Pavucek, Jr. |
| | | | Chief Financial Officer |
| | | | (Principal financial and accounting officer) |
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