UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2009
OR
¨ 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 0-18170
BioLife Solutions, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
94-3076866
(State or Other Jurisdiction
of Incorporation)
(IRS Employer
Identification No.)
3303 Monte Villa Parkway, Suite 310
Bothell, WA 98021
(Address of Principal Executive Offices, Including Zip Code)
(425) 402-1400
(Registrants Telephone Number, Including Area Code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ¨ No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer, or a smaller reporting company (as defined in Rule 12b-2 of the Exchange Act):
Large Accelerated Filer ¨
Accelerated Filer ¨
Non-Accelerated Filer ¨ (Do not check if a smaller reporting company)
Smaller reporting company þ
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No þ
The registrant had 69,639,854 shares of Common Stock, $0.001 par value per share, outstanding as of April 30, 2009.
BIOLIFE SOLUTIONS, INC.
FOR THE QUARTER ENDED MARCH 31, 2009
TABLE OF CONTENTS
Page
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
1
Balance Sheets as of March 31, 2009 (unaudited) and December 31, 2008
Statements of Operations (unaudited) for the three-month periods ended March 31, 2009 and 2008
2
Statements of Cash Flows (unaudited) for the three-month periods ended March 31, 2009 and 2008
3
Notes to Financial Statements (unaudited)
4
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
8
Item 4T. Controls and Procedures
11
PART II. OTHER INFORMATION
Item 6. Exhibits
12
Signatures
13
Index to Exhibits
14
Item 1.
Financial Statements
Balance Sheets(unaudited)
March 31,
December 31,
2009
2008
Assets
Current assets
Cash and cash equivalents
$
428,196
98,724
Accounts receivable, trade, net of allowance for doubtful accounts of $12,000 and $29,000 at March 31, 2009 and December 31, 2008, respectively
244,963
279,192
Other receivable
79,904
Inventories
453,011
625,291
Prepaid expenses and other current assets
123,816
19,483
Total current assets
1,329,890
1,022,690
Property and equipment
Modular clean room
202,270
Furniture and computer equipment
120,693
109,753
Manufacturing and other equipment
256,069
210,558
Subtotal
579,032
320,311
Less: Accumulated depreciation and amortization
(199,788
)
(190,214
Net property and equipment
379,244
130,097
Long term deposits
36,166
17,835
Total assets
1,745,300
1,170,622
Liabilities and Stockholders Equity (Deficiency)
Current liabilities
Accounts payable
586,150
659,133
Accrued expenses
203,929
242,181
Accrued interest, related parties
385,814
Deferred revenue
19,166
25,833
Promissory notes payable, related parties
6,463,127
Total current liabilities
7,658,186
927,147
Long term liabilities
5,063,127
278,961
Deferred revenue, long term
70,000
72,500
Total liabilities
7,728,186
6,341,735
Commitments and Contingencies
Stockholders' equity (deficiency)
Common stock, $0.001 par value; 100,000,000 shares authorized, 69,639,854 issued and outstanding at March 31, 2009 and December 31, 2008
69,640
Additional paid-in capital
42,229,912
42,202,117
Accumulated deficit
(48,282,438
(47,442,870
Total stockholders' equity (deficiency)
(5,982,886
(5,171,113
Total liabilities and stockholders' equity (deficiency)
See accompanying notes.
Statements of Operations(unaudited)
Three-month Period
Ended March 31,
Revenue
Product sales
367,945
306,384
Licensing revenue
9,167
11,250
Total revenue
377,112
317,634
Cost of product sales
230,277
158,402
Gross profit
146,835
159,232
Operating expenses
Research and development
133,624
111,302
Sales and marketing
123,581
96,086
General and administrative
456,075
512,458
Manufacturing start-up costs
166,951
Total operating expenses
880,231
719,846
Operating loss
(733,396
(560,614
Other income (expenses)
Interest income
681
4,255
Interest expense
(106,853
(45,418
Amortization of deferred financing costs
(43,750
Total other income (expenses)
(106,172
(84,913
Net Loss
(839,568
(645,527
Basic and diluted net loss per common share
(0.01
Basic and diluted weighted average common shares used to calculate net loss per common share
69,639,854
69,606,520
Statements of Cash Flows(unaudited)
Cash flows from operating activities
Net loss
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation
9,573
6,864
43,750
Share-based compensation expense
27,794
23,461
Change in operating assets and liabilities
(Increase) Decrease in
Accounts receivable, trade
34,229
85,754
(79,904
172,280
2,015
(122,664
(181,555
Increase (Decrease) in
(72,982
186,876
(38,251
(82,801
106,853
45,418
(9,167
(1,250
Net cash used in operating activities
(811,807
(516,995
Cash flows from investing activity
Purchase of property and equipment
(258,721
(5,653
Net cash used in investing activity
Cash flows from financing activities
Proceeds from promissory notes payable, related parties
1,400,000
600,000
Proceeds from exercise of options
2,333
Net cash provided by financing activities
602,333
Net increase in cash and cash equivalents
329,472
79,685
Cash and cash equivalents - beginning of period
56,497
Cash and cash equivalents - end of period
136,182
Non-cash items:
Transfer of accrued interest to promissory notes payable
113,127
Notes to Financial Statements(unaudited)
1.
Nature of the Business
BioLife Solutions, Inc. ("BioLife or the Company) develops and markets patented hypothermic storage and cryopreservation solutions for cells, tissues, and organs, and provides contracted research and development and consulting services related to optimization of biopreservation processes and protocols. Its proprietary HypoThermosol® and CryoStor™ biopreservation media products are marketed to companies, laboratories, and academic institutions engaged in research and commercial clinical applications. The Company’s line of serum-free and protein-free biopreservation solutions are fully defined and formulated to reduce preservation-induced, delayed-onset cell damage and death. This platform enabling technology provides academic and clinical researchers significant improvement in biologic source material shelf life and also post-thaw isolated cell, tissue, and organ vi ability and function.
2.
Financial Condition
The Company has been unable to generate sufficient income from operations in order to meet its operating needs and has an accumulated deficit of approximately $48 million at March 31, 2009. This raises doubt about the Companys ability to continue as a going concern.
In February, June and September, 2007, in order to secure capital necessary to continue its operations, the Company borrowed an aggregate of $2,750,000 in equal amounts, from Thomas Girschweiler, a director and stockholder of the Company, and Walter Villiger, an affiliate of the Company, each a non-U.S. Person (as defined in Regulation S of the Securities Act of 1933, as amended) (collectively, the Investors). Each loan was evidenced by a Promissory Note (collectively, Notes). Each Note, together with interest accrued thereon at the rate of 7% per annum (collectively, the Conversion Amount), was due and payable in one lump sum on the earlier of (a), in the case of the February Notes, the second anniversary of the date thereof and, in the case of the June Notes and the September Notes, June 30, 2008 and September 30, 2008, respectively, (b) an Event of Defa ult (as defined in the Notes) or (c) sale, merger or change in control of the Company, as defined. In addition, if any Note was outstanding at the time of any bona fide equity financing of the Company of at least $1,000,000 (a Financing), then the Note holder was able to convert the Note into that number of shares or units of the equity securities of the Company sold in the Financing (New Equity Securities) as is equal to the Conversion Amount divided by, in the case of the February Notes, 85% of the per share or per unit purchase price of the New Equity Securities and, in the case of the June Notes and September Notes, 100% of the per share or per unit purchase price of the New Equity Securities.
On January 11, 2008, the Company entered into a Secured Convertible Multi-Draw Term Loan Facility Agreement with each of the Investors, pursuant to which each Investor extended to the Company a secured convertible multi-draw term loan facility (the Facility) of $2,500,000, which Facility (a) incorporates (i) a refinancing of the existing indebtedness of the Company to the Investor, represented by the Notes, and accrued interest thereon, in the aggregate amount of $1,431,563.30, (ii) a current advance of $300,000, and (iii) a commitment to advance to the Company, from time to time, additional amounts up to a maximum of $768,436.70, (b) bears interest at the rate of 7% per annum on the principal balance outstanding from time to time, (c) is evidenced by a secured convertible multi-draw term loan note (the Multi-Draw Term Loan Note), due and payable, together with accrued interest thereon, the earlie r of (i) January 11, 2010, or (ii) an Event of Default (as defined in the Multi-Draw Term Loan Note), (d) if outstanding at the time of any bona fide equity financing of the Company of at least Two Million Dollars ($2,000,000) (a Financing), at the option of the Investor, may be converted into that number of fully paid and non-assessable shares or units of the equity security(ies) of the Company sold in the Financing (New Equity Securities) as is equal to the quotient obtained by dividing the principal amount of the Facility outstanding at the time of the conversion plus accrued interest thereon by 85% of the per share or per unit purchase price of the New Equity Securities, and (e) is secured by all of the Companys assets.
In May and July 2008, the Company received an additional $1,000,000 in total from the Investors pursuant to the Multi-Draw Term Loan Facility. On October 20, 2008, each Facility was increased by $2,000,000 to $4,500,000 (an aggregate of $9,000,000), and, on October 24, 2008, the Company received an additional $600,000 in total from the Investors pursuant to the amended Multi-Draw Term Loan Facilities and in January 2009, the Company received an additional $1,400,000 in total from the Investors pursuant to the amended Multi-Draw Term Loan Facilities, which brought the Companys total principal balance owed under the Multi-Draw Term Loan Notes to $6,463,127, which leaves $2,536,873 left to draw from the Facilities at March 31, 2009. In May 2009, the Company received an additional $500,000 in total from the Investors pursuant to the Facilities.
Management believes that continued access to the amended Multi-Draw Term Loan Facilities, in combination with cash generated from operations, will provide sufficient funds for the next twelve months. However, the Company would require additional capital in the immediate short term if its ability to draw on the amended Multi-Draw Term Loan Facilities is restricted or terminated. Other factors that would negatively impact the Companys ability to finance its operations include (i) significant reductions in revenue (ii) increased capital expenditures (iii) significant increases in cost of goods and operating expenses or; (iv) an adverse outcome resulting from current litigation. The Company expects that it may need additional capital to reach a sustainable level of positive cash flow. Although the Investors who have provided the amended Multi-Draw Term Loan Facilities have historically demonstrated a willingness to gra nt access to the Facilities, there is no assurance they will continue to do so in the future. If the Investors were to become unwilling to provide access to additional funds through the amended Multi-Draw Term Loan Facilities, the Company would need to find immediate additional sources of capital. There can be no assurance that such capital would be available at all, or if available, that the terms of such financing would not be dilutive to other stockholders. If the Company is unable to secure additional capital as circumstances require, it may not be able to continue its operations.
These financial statements assume that the Company will continue as a going concern. If the Company is unable to continue as a going concern, it may be unable to realize its assets and discharge its liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or to amounts and classification of liabilities that may be necessary should the Company be unable to continue as a going concern.
3.
Summary of Significant Accounting Policies
Basis of Presentation
The unaudited financial statements have been prepared by the Company, according to the rules and regulations of the Securities and Exchange Commission (SEC) and, therefore, certain information and disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States have been omitted.
In the opinion of management, the accompanying unaudited financial statements for the periods presented reflect all adjustments, which are normal and recurring, necessary to fairly state the financial position, results of operations and cash flows. These unaudited financial statements should be read in conjunction with the audited financial statements included on Form 10-K for the fiscal year ended December 31, 2008 filed with the Securities and Exchange Commission (SEC).
Reclassifications
Certain prior period amounts in the financial statements have been reclassified to conform to current period presentation. There has been no impact on previously reported net loss or shareholders equity.
Recent Accounting Pronouncements
In April 2009, the Financial Accounting Standards Board ("FASB") issued FASB Staff Position (FSP) FAS 107-1 and Accounting Principles Board 28-1 Interim Disclosures about Fair Value of Financial Instruments (FSP 107-1). FSP 107-1 amends Statement of Financial Accounting Standards (SFAS) No. 107, Disclosures about Fair Value of Financial Instruments, to require an entity to provide disclosures about fair value of financial instruments in interim financial statements. FSP 107-1 is to be applied prospectively and is effective for interim and annual periods ending after June 15, 2009. The Company will adopt FSP 107-1 for the quarter ending June 30, 2009.
4.
Product, Finished Goods
399,427
502,089
Product, Work in Progress
113,382
Raw Materials
53,584
9,820
Total Inventory
5
5.
Share-based Compensation
During 1998, the Company adopted the 1998 Stock Option Plan. An aggregate of 4,000,000 shares of common stock are reserved for issuance upon the exercise of options granted under the plan. In September 2005, the shareholders approved an increase in the number of shares available for issuance to 10,000,000 shares. The purchase price of the common stock underlying each option may not be less than the fair market value at the date the option is granted (110% of fair market value for optionees that own more than 10% of the voting power of the Company). The plan expired on August 31, 2008. The options are exercisable for up to ten years from the grant date.
During the three month period ended March 31, 2009, and subsequent to the expiration of the Companys 1998 Stock Option Plan, the Company issued, outside of its plans, non-incentive stock options for an aggregate of 1,765,000 shares of Company common stock to five directors and four employees. Options to purchase 750,000 shares were awarded to five outside directors which vest 100% on the first anniversary date of the awards. Options to purchase 1,015,000 shares were awarded to four employees which vests as follows: twenty-five percent on the first anniversary date of the award, and then one-thirty sixth of the remaining balance in each of the ensuing thirty-six months following the first anniversary date of the award.
Under SFAS No. 123R, the Company recorded stock compensation expense of $27,794 and $23,461 for the three months ended March 31, 2009 and 2008, respectively.
As of March 31, 2009, the Company had approximately $204,761 of unrecognized compensation expense related to unvested stock options. The Company expects to recognize this compensation expense over a weighted average period of approximately two and one half years.
The Company uses the Black-Scholes options-pricing model (Black-Scholes model) to value share-based employee and non-employee director stock option awards. The determination of fair value of stock-based payment awards using an option-pricing model requires the use of certain estimates and assumptions that affect the reported amount of share-based compensation cost recognized in the Statements of Operations. Among these are expected term of options, estimated forfeitures, expected volatility of the Companys stock price, expected dividends and risk-free interest rate.
Three-month Period Ended
Risk free interest rate
1.78
%
2.70
Dividend yield
0.0
Expected term (in years)
6.4
7
Volatility
82
74
A summary of the Companys stock option activity and related information for the three months ended March 31, 2009 is as follows:
Weighted Average
Exercise
Shares
Price
Outstanding at December 31, 2008
8,000,000
0.09
Granted
1,765,000
Exercised
Forfeited/expired
(40,000
0.25
Outstanding at March 31, 2009
9,725,000
Outstanding options vested and exercisable at March 31, 2009
4,789,167
The weighted average grant-date fair value of option awards granted was $.06 and $.04 per share during the three months ended March 30, 2009 and 2008, respectively.
6
Information related to options outstanding at March 31, 2009 is as follows:
Weighted
Average
Remaining
Range of
Number
Contractual
Exercise Prices
of Shares
Life (in years)
$0.04-$0.07
3,000,000
8.30
0.06
$0.08-$0.09
5,910,000
8.24
0.08
$0.10-$1.25
815,000
7.18
0.16
8.10
6.
Net Loss per Common Share
Basic net income (loss) per common share is calculated by dividing the net income (loss) by the weighted average number of common shares outstanding during the period. Diluted earnings per share is calculated by dividing net income (loss) by the weighted average number of common shares outstanding plus dilutive common stock equivalents outstanding during the period. Common stock equivalents are excluded for the periods ending March 31, 2009 and 2008 as the effect would be anti-dilutive. Common stock equivalents include stock options, warrants, and convertible debt.
7.
Related Party Transactions
The Company incurred $15,956 and $44,622 in legal fees during the three months ended March 31, 2009 and 2008, respectively, for services provided by a law firm in which a director and stockholder of the Company is a partner. Pursuant to a consulting agreement disclosed on the Companys 8-K filing dated November 19, 2007, the Company incurred $30,000 in consulting fees during the three months ended March 31, 2009 and 2008, for services provided by a director and stockholder of the Company.
Included in accounts payable and accrued expenses is $39,165 and $37,116 due to related parties for services rendered as of March 31, 2009 and December 31, 2008, respectively.
8.
Subsequent Event
Subsequent to period ended March 31, 2009, the Company received an additional $500,000 in total from the Investors pursuant to the Facilities. This draw will provide funds for the Companys operating expenses in the second quarter of 2009.
Item 2.
Managements Discussion and Analysis of Financial Condition and Results of Operations
The statements contained in this Quarterly Report on Form 10-Q, including under the section titled Managements Discussion and Analysis of Financial Condition and Results of Operations, include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements regarding the Company managements expectations, hopes, beliefs, intentions or strategies regarding the future. The words believe, may, will, estimate, continue, anticipate, intend, expect, plan and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements contained in th is Quarterly Report on Form 10-Q is based on its current expectations and beliefs concerning future developments and their potential effects on the Company. There can be no assurance that future developments affecting it will be those that the Company anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include those factors described in greater detail in the risk factors disclosed in our Form 10-K for the fiscal year ended December 31, 2008 filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those anticipated in these forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Overview
Managements discussion and analysis provides additional insight into BioLife Solutions, Inc. and is provided as a supplement to, and should be read in conjunction with, its annual report on Form 10-K for the fiscal year ended December 31, 2008 filed with the Securities and Exchange Commission.
We develop and market patented hypothermic storage and cryopreservation solutions for cells, tissues, and organs, and provide contracted research and development and consulting services related to optimization of biopreservation processes and protocols. Our proprietary HypoThermosol® and CryoStor™ biopreservation media products are marketed to companies, laboratories, and academic institutions engaged in research and commercial clinical applications. Our line of serum-free and protein-free biopreservation solutions are fully defined and formulated to reduce preservation-induced, delayed-onset cell damage and death. This platform enabling technology provides academic and clinical researchers significant improvement in biologic source material shelf life and also post-thaw isolated cell, tissue, and organ viability and function.
Critical Accounting Policies and Significant Judgments and Estimates
Managements discussion and analysis of the Companys financial condition and results of operations is based on its financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles for interim financial reporting. The preparation of financial statements requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and reported revenues and expenses during the reporting periods presented. On an ongoing basis, it evaluates estimates, including those related to share-based compensation and expense accruals. The Company bases its estimates on historical experience and on other factors that it believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities tha t are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions. The Companys critical accounting policies and estimates have not changed significantly from those policies and estimates disclosed under the heading Critical Accounting Policies and Estimates under Item 7 in the Companys Form 10-K for the fiscal year ended December 31, 2008, filed with the Securities and Exchange Commission.
Results of Operations
Three-month Periods Ended March 31, 2009 and 2008
Product sales for the three months ended March 31, 2009 increased $61,561, or 20%, to $367,945, compared to $306,384 for the three months ended March 31, 2008. This increase in revenue was primarily due to the acquisition of new customers and growth in orders from existing customers. Additionally, the Company had licensing revenue for the three months ended March 31, 2009 of $9,167, compared to $11,250 for the three months ended March 31, 2008 related to three license agreements. Despite the year-over-year revenue growth, the Company did see some customers postpone or reduce order sizes due to the general economic slowdown, particularly in the cord blood and cell supplier market segments.
Cost of Product Sales
Cost of product sales for the three months ended March 31, 2009 increased by $71,875, or 45%, to $230,277, compared to $158,402 for the three months ended March 31, 2008, resulting in a gross margin as a percentage of revenue of 39% as compared to 50% for the same period in 2008. The increase in cost of product sales is primarily attributable to the higher production costs at the companys CMO compared to the prior periods when the production costs were lower. To reduce cost of product sales, and enhance its production flexibility, the Company is transitioning to internal manufacturing and expects to begin production in the second calendar quarter of 2009.
Research and Development Expenses
Expenses relating to research and development for the three months ended March 31, 2009 increased $22,322, or 20%, to $133,624, compared to $111,302 for the three months ended March 31, 2008. The increase primarily was due to approximately $18,000 of obsolete raw materials and expired products that were expensed and will be used in research and development projects, and a slight increase in headcount costs, offset by a decrease in travel and related expenses.
Sales and Marketing Expenses
For the three months ended March 31, 2009, sales and marketing expenses increased $27,495, or 29%, to $123,581, compared to $96,086 for the three months ended March 31, 2008. The increase primarily is due to higher compensation and benefit costs of approximately $46,000 attributable to payroll costs now classified in this expense category and an increase in marketing related expenses of approximately $12,000, offset by a decrease of approximately $36,000 in trade show costs due to the timing of certain trade shows that the Company attends.
General and Administrative Expenses
For the three months ended March 31, 2009, general and administrative expenses decreased $56,383, or 11%, to $456,075, compared to $512,458 for the three months ended March 31, 2008. The reduction primarily is due to a decrease of approximately $79,000 in litigation related legal fees, and a decrease of approximately $10,000 in travel related expenses. Offsetting these decreases is an increase in bad debt expense of approximately $18,000 attributed to uncollectible accounts receivable.
Manufacturing Start-up Costs
For the three months ended March 31, 2009, manufacturing start-up costs were $166,951. During the third quarter of 2007, as a result of relocating the Company from Owego, NY to Bothell, WA, the Company decided to outsource its manufacturing and entered into a contract with a CMO. One-time start-up costs related to the outsourcing of its manufacturing were expensed as incurred. In the third quarter of 2008, to reduce cost of product sales and enhance its production flexibility, the Company decided to transition to internal manufacturing and expects to begin production in the second calendar quarter of 2009.
Interest Expense
Interest expense increased to $106,853 for the three months ended March 31, 2009 from $45,418 for the three months ended March 31, 2008. The increase is due to a higher average debt balance.
9
Operating Expenses and Net Loss
For the three months ended March 31, 2009, operating expenses (excluding product costs) increased $160,385, or 22%, to $880,231, compared to $719,846 for the three months ended March 31, 2008. This increase primarily is attributed to the manufacturing start-up costs as the Company transitions into bringing the manufacturing process in-house. The Company reported a net loss of ($839,568) for the three months ended March 31, 2009, compared to a net loss of ($645,527) for the three months ended March 31, 2008.
Liquidity and Capital Resources
As of March 31, 2009, the Company had $428,196 in cash and cash equivalents. To date, the Company has financed its operations primarily through proceeds from debt instruments including the Secured Convertible Multi-draw Term Loan Facilities described in detail below.
On January 11, 2008, the Company entered into a Secured Convertible Multi-Draw Term Loan Facility Agreement with each of Thomas Girschweiler, a director and stockholder of the Company, and Walter Villiger, an affiliate of the Company (the Investors), pursuant to which each Investor extended to the Company a secured convertible multi-draw term loan facility (the Facility) of $2,500,000, which Facility (a) incorporates (i) a refinancing of the existing indebtedness of the Company to the Investor, represented by the Notes, and accrued interest thereon, in the aggregate amount of $1,431,563.30, (ii) a current advance of $300,000, and (iii) a commitment to advance to the Company, from time to time, additional amounts up to a maximum of $768,436.70, (b) bears interest at the rate of 7% per annum on the principal balance outstanding from time to time, (c) is evidenced by a secured convertible multi-draw term loan note (the & #147;Multi-Draw Term Loan Note), due and payable, together with accrued interest thereon, the earlier of (i) January 11, 2010, or (ii) an Event of Default (as defined in the Multi-Draw Term Loan Note), (d) if outstanding at the time of any bona fide equity financing of the Company of at least Two Million Dollars ($2,000,000) (a Financing), at the option of the Investor, may be converted into that number of fully paid and non-assessable shares or units of the equity security(ies) of the Company sold in the Financing (New Equity Securities) as is equal to the quotient obtained by dividing the principal amount of the Facility outstanding at the time of the conversion plus accrued interest thereon by 85% of the per share or per unit purchase price of the New Equity Securities, and (e) is secured by all of the Companys assets.
In May and July 2008, the Company received an additional $1,000,000 in total from the Investors pursuant to the Multi-Draw Term Loan Facilities. On October 20, 2008, each Facility was increased by $2,000,000 to $4,500,000 (an aggregate of $9,000,000), and, on October 24, 2008, the Company received an additional $600,000 in total from the Investors pursuant to the amended Multi-Draw Term Loan Facilities and in January 2009, the Company received an additional $1,400,000 in total from the Investors pursuant to the amended Multi-Draw Term Loan Facilities, which brought the Companys total principal balance owed under the Multi-Draw Term Loan Notes to $6,463,127, which leaves $2,536,873 left to draw from the Facilities as of March 31, 2009. In May 2009, the Company received an additional $500,000 in total from the Investors pursuant to the Facilities.
Net Cash Used in Operating Activities
For the three month period ended March 31, 2009, net cash used in operating activities was $(811,807) as compared to net cash used in operating activities of $(516,995) for the three month period ended March 31, 2008. The $294,812 increase in net cash used by operations primarily is reflected in the higher net loss for the quarter, partially offset by non-cash operating expenses including depreciation, amortization of deferred financing costs, share-based compensation, and changes in operating assets and liabilities.
Net Cash Provided by Investing Activities
Net cash used in investing activities consist of purchases of property and equipment. For the three month period ended March 31, 2009, the aggregate investment in property and equipment was $(258,721), compared to $(5,653) for the three month period ended March 31, 2008 primarily due to the manufacturing clean room build-out.
Net Cash Provided by Financing Activities
Net cash provided by financing activities totaled $1,400,000 for the three month period ended March 31, 2009, which resulted from the draws taken on the Multi-Draw Term Loan Facilities. Net cash provided by financing activities totaled $602,333 for the three month period ended March 31, 2008 resulting from draws taken on the Multi-Draw Term Loan Facilities.
10
Operating Capital and Capital Expenditure Requirements
The Company believes that continued access to the Multi-Draw Term Loan Facilities, in combination with cash generated from operations, will provide sufficient funds for the next twelve months. However, the Company would require additional capital in the immediate short term if the Companys ability to draw on the Multi-Draw Term Loan Facilities is restricted or terminated. Other factors that would negatively impact the Companys ability to finance its operations include (i) significant reductions in revenue (ii) increased capital expenditures (iii) significant increases in cost of goods and operating expenses or; (iv) an adverse outcome resulting from current litigation. The Company expects that it may need additional capital to reach a sustainable level of positive cash flow. Although the Investors who have provided the Multi-Draw Term Loan Facilities have historically demonstrated a willingness to grant access to the Facilities, there is no assurance they will continue to do so in the future. If the Investors were to become unwilling to provide access to additional funds through the Multi-Draw Term Loan Facilities, the Company will need to find immediate additional sources of capital and there can be no assurance that such capital would be available at all, or if available, that the terms of such financing would not be dilutive to other stockholders. If the Company is unable to secure additional capital, as circumstances require, it may not be able to continue its operations.
Contractual Obligations
The Company did not enter into any significant contractual obligations during the three month period ended March 31, 2009. It had no significant contractual obligations not fully recorded on our Balance Sheets or fully disclosed in the Notes to our Financial Statements in Form 10-K for the fiscal year ended December 31, 2008, filed with the Securities and Exchange Commission. The Company did not have any off-balance sheet arrangements as defined in S-K 303(a)(4)(ii).
Item 4T.
Controls and Procedures
The Company maintains disclosure controls and procedures designed to ensure that it is able to collect the information required to be disclosed in the reports that are filed with the SEC, and to record, process, summarize and disclose this information within the time periods specified in the rules of the SEC. Based on an evaluation of its disclosure controls and procedures as of the end of the period covered by this report conducted by its management, with the participation of the Companys Chief Executive/Chief Financial Officer, the Chief Executive/Chief Financial Officer believes that these controls and procedures are effective to ensure that it is able to collect, process and disclose the information required to be disclosed in the reports that are filed with the SEC within the required time periods.
There were no changes in the Companys internal control over financial reporting during the first quarter of fiscal 2009 that have materially affected, or are reasonably likely to materially affect, its internal control over financial reporting.
PART II: Other Information
Item 6.
Exhibits
See accompanying Index to Exhibits included after the signature page of this report for a list of exhibits filed or furnished with this report.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: May 15, 2009
/s/ MICHAEL RICE
Michael Rice
President and Chief Executive Officer
(Principal Executive and Financial Officer)
INDEX TO EXHIBITS
Exhibit No.
Description
31.1
Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002