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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
[X] | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2011
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:001-33827
BG MEDICINE, INC.
(Exact name of registrant as specified in its charter)
Delaware | 04-3506204 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
610 Lincoln Street North Waltham, Massachusetts | 02451 | |
(Address of principal executive offices) | (Zip Code) | |
(781) 890-1199 | ||
(Registrant’s 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 [X] 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 [X] No [ ]
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | [ ] | Accelerated filer [ ] | ||||
Non-accelerated filer [X] (Do not check if a smaller reporting company) | Smaller reporting company | [ ] |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [X]
As of October 31, 2011, the registrant had 19,474,295 shares of common stock outstanding.
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BG Medicine, Inc.
Table of Contents
BG Medicine, Inc. and Subsidiary
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, 2011 | December 31, 2010 | |||||||
(in thousands, except share and per share data) | ||||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 13,101 | $ | 2,425 | ||||
Marketable securities | 14,248 | - | ||||||
Restricted cash | 631 | - | ||||||
Accounts receivable | 88 | 786 | ||||||
Inventory | 330 | - | ||||||
Prepaid expenses and other current assets | 779 | 405 | ||||||
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Total current assets | 29,177 | 3,616 | ||||||
Property and equipment, net | 348 | 604 | ||||||
Intangible assets, net | 477 | 541 | ||||||
Deferred offering costs | - | 2,229 | ||||||
Deposits and other assets | 37 | 37 | ||||||
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Total assets | $ | 30,039 | $ | 7,027 | ||||
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Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) | ||||||||
Current liabilities | ||||||||
Term loan, current portion | $ | - | $ | 96 | ||||
Bridge notes, including accrued interest | - | 6,276 | ||||||
Accounts payable | 863 | 1,380 | ||||||
Accrued expenses | 2,998 | 2,822 | ||||||
Deferred revenue and customer deposits | 1,442 | 1,521 | ||||||
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Total current liabilities | 5,303 | 12,095 | ||||||
Warrant liability | 11 | 248 | ||||||
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Total liabilities | 5,314 | 12,343 | ||||||
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Redeemable convertible preferred stock | ||||||||
Series A redeemable convertible preferred stock; $.001 par value; no shares authorized or issued at September 30, 2011 and 16,017,067 shares authorized at December 31, 2010; 15,823,566 shares issued and outstanding at December 31, 2010 | - | 23,735 | ||||||
Series A-1 redeemable convertible preferred stock; $.001 par value; no shares authorized or issued at September 30, 2011 and 2,475,247 shares authorized at December 31, 2010; 2,475,247 shares issued and outstanding at December 31, 2010 | - | 5,000 | ||||||
Series C redeemable convertible preferred stock; $.001 par value; no shares authorized or issued at September 30, 2011 and 1,369,863 shares authorized at December 31, 2010; 1,369,863 shares issued and outstanding at December 31, 2010 | - | 3,694 | ||||||
Series D redeemable convertible preferred stock; $.001 par value; no shares authorized or issued at September 30, 2011 and 6,246,151 shares authorized at December 31, 2010; 6,153,846 shares issued and outstanding at December 31, 2010 | - | 39,664 | ||||||
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Total redeemable convertible preferred stock | - | 72,093 | ||||||
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Stockholders' equity (deficit) | ||||||||
Series B convertible preferred stock; $.001 par value; no shares authorized or issued at September 30, 2011 and 2,000,000 shares authorized at December 31, 2010; 1,138,716 shares issued and outstanding at December 31, 2010 | - | 1,708 | ||||||
Preferred stock; $.001 par value; 5,000,000 shares authorized at September 30, 2011; no shares issued and outstanding | - | - | ||||||
Common stock; $.001 par value; 100,000,000 shares authorized at September 30, 2011 and 60,000,000 shares authorized at December 31, 2010; 19,474,295 and 2,994,668 shares issued and outstanding at September 30, 2011 and December 31, 2010, respectively | 19 | 3 | ||||||
Additional paid-in capital | 133,292 | 16,618 | ||||||
Accumulated deficit | (108,586 | ) | (95,738 | ) | ||||
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Total stockholders’ equity (deficit) | 24,725 | (77,409 | ) | |||||
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Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | $ | 30,039 | $ | 7,027 | ||||
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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BG Medicine, Inc. and Subsidiary
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
Revenue | $ | 179 | $ | 98 | $ | 1,255 | $ | 620 | ||||||||
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Cost of Revenue and Operating Expenses: | ||||||||||||||||
Cost of revenue | 84 | 172 | 428 | 650 | ||||||||||||
Research and development | 1,936 | 1,681 | 6,010 | 5,596 | ||||||||||||
Selling, general and administrative | 3,072 | 1,803 | 7,567 | 6,224 | ||||||||||||
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Total cost of revenue and operating expenses | 5,092 | 3,656 | 14,005 | 12,470 | ||||||||||||
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Loss from operations | (4,913) | (3,558) | (12,750) | (11,850) | ||||||||||||
Interest income | 10 | 1 | 25 | 4 | ||||||||||||
Interest expense | - | (945) | (90) | (1,964) | ||||||||||||
Other expense | 22 | 15 | (33) | (29) | ||||||||||||
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Net loss | (4,881) | (4,487) | (12,848) | (13,839) | ||||||||||||
Accretion of redeemable convertible preferred stock | - | (260) | (118) | (769) | ||||||||||||
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Net loss attributable to common stockholders | $ | (4,881) | $ | (4,747) | $ | (12,966) | $ | (14,608) | ||||||||
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Net loss attributable to common stockholders per share - basic and diluted | $ | (0.25) | $ | (1.59) | $ | (0.77) | $ | (4.93) | ||||||||
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Weighted-average common shares outstanding used in computing per share amounts - basic and diluted | 19,344,905 | 2,994,549 | 16,925,693 | 2,963,626 | ||||||||||||
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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BG Medicine, Inc. and Subsidiary
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ (DEFICIT) EQUITY
Series A redeemable convertible preferred stock | Series A-1 redeemable convertible preferred stock | Series C redeemable preferred stock | Series D redeemable convertible preferred stock | Total redeemable | ||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | stock | ||||||||||||||||||||||||||||
(in thousands, except share data) | ||||||||||||||||||||||||||||||||||||
At January 1, 2011 | 15,823,566 | $ | 23,735 | 2,475,247 | $ | 5,000 | 1,369,863 | $ | 3,694 | 6,153,846 | $ | 39,664 | $ | 72,093 | ||||||||||||||||||||||
Net loss | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||
Issuance of shares upon initial public offering, net of offering costs of approximately $5.4 million | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||
Conversion of bridge notes into common stock upon initial public offering | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||
Conversion of redeemable convertible preferred stock into common stock upon initial public offering | (15,823,566 | ) | (23,735 | ) | (2,475,247 | ) | (5,000 | ) | (1,369,863 | ) | (3,744 | ) | (6,153,846 | ) | (39,732 | ) | (72,211 | ) | ||||||||||||||||||
Conversion of convertible preferred stock into common stock upon initial public offering | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||
Issuance of common stock upon exercise of warrants | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||
Issuance of common stock upon exercise of stock options | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||
Accretion of redeemable convertible preferred stock | - | - | - | - | - | 50 | - | 68 | 118 | |||||||||||||||||||||||||||
Reclassification of warrants to equity | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||
Stock-based compensation | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||
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At September 30, 2011 | - | $ | - | - | $ | - | - | $ | - | - | $ | - | $ | - | ||||||||||||||||||||||
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Series B convertible preferred stock | Common stock | Additional paid-in capital | Accumulated deficit | Total stockholders’ (deficit) equity | ||||||||||||||||||||||||
Shares | Amount | Shares | Amount | |||||||||||||||||||||||||
(in thousands, except share data) | ||||||||||||||||||||||||||||
At January 1, 2011 | 1,138,716 | $ | 1,708 | 2,994,668 | $ | 3 | $ | 16,618 | $ | (95,738 | ) | $ | (77,409 | ) | ||||||||||||||
Net loss | - | - | - | - | - | (12,848 | ) | (12,848 | ) | |||||||||||||||||||
Issuance of shares upon initial public offering, net of offering costs of approximately $5.4 million | - | - | 5,750,000 | 6 | 34,812 | - | 34,818 | |||||||||||||||||||||
Conversion of bridge notes into common stock upon initial public offering | - | - | 908,651 | 1 | 6,360 | - | 6,361 | |||||||||||||||||||||
Conversion of redeemable convertible preferred stock into common stock upon initial public offering | - | - | 9,222,672 | 9 | 72,202 | - | 72,211 | |||||||||||||||||||||
Conversion of convertible preferred stock into common stock upon initial public offering | (1,138,716 | ) | (1,708 | ) | 319,259 | - | 1,708 | - | - | |||||||||||||||||||
Issuance of common stock upon exercise of warrants | - | - | 109,638 | - | - | - | - | |||||||||||||||||||||
Issuance of common stock upon exercise of stock options | - | - | 169,407 | - | 147 | - | 147 | |||||||||||||||||||||
Accretion of redeemable convertible preferred stock | - | - | - | - | (118 | ) | - | (118 | ) | |||||||||||||||||||
Reclassification of warrants to equity | - | - | - | - | 272 | - | 272 | |||||||||||||||||||||
Stock-based compensation | - | - | - | - | 1,291 | - | 1,291 | |||||||||||||||||||||
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At September 30, 2011 | - | $ | - | 19,474,295 | $ | 19 | $ | 133,292 | $ | (108,586 | ) | $ | 24,725 | |||||||||||||||
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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BG Medicine, Inc. and Subsidiary
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Nine Months Ended September 30, | ||||||||||
2011 | 2010 | |||||||||
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Cash flows from operating activities | ||||||||||
Net loss | $ | (12,848) | $ | (13,839) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities | ||||||||||
Depreciation and amortization | 330 | 414 | ||||||||
Stock-based compensation | 1,291 | 1,738 | ||||||||
Non-cash interest expense and changes in fair value of warrant liability | 124 | 1,892 | ||||||||
Changes in operating assets and liabilities | ||||||||||
Restricted cash | (631) | - | ||||||||
Accounts receivable | 698 | 98 | ||||||||
Prepaid expenses, inventory, and other current assets | (649) | 84 | ||||||||
Accounts payable and accrued expenses | 568 | 80 | ||||||||
Deferred revenue and customer deposits | (79) | 88 | ||||||||
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Net cash flows used in operating activities | (11,196) | (9,445) | ||||||||
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Cash flows from investing activities | ||||||||||
Purchases of property and equipment and intangibles | (65) | (59) | ||||||||
Purchases of investments | (16,048) | (598) | ||||||||
Proceeds from sales and maturities of investments | 1,800 | 2,650 | ||||||||
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Net cash flows (used in) provided by investing activities | (14,313) | 1,993 | ||||||||
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Cash flows from financing activities | ||||||||||
Proceeds from initial public offering | 37,433 | - | ||||||||
Proceeds from issuance of promissory notes and warrants | - | 4,000 | ||||||||
Proceeds from exercise of stock options | 147 | 42 | ||||||||
Payments on term loan | (100) | (900) | ||||||||
Costs related to initial public offering | (1,295) | (1,178) | ||||||||
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Net cash flows provided by financing activities | 36,185 | 1,964 | ||||||||
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Net increase (decrease) in cash and cash equivalents | 10,676 | (5,488) | ||||||||
Cash and cash equivalents, beginning of period | 2,425 | 8,343 | ||||||||
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Cash and cash equivalents, end of period | $ | 13,101 | $ | 2,855 | ||||||
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Supplemental disclosure of cash flow information | ||||||||||
Cash paid for interest | $ | 2 | 104 | |||||||
Accrued deferred offering costs | - | 306 | ||||||||
Settlement of 2009 accrued bonus with stock options | - | 163 | ||||||||
Conversion of preferred stock | 73,919 | - | ||||||||
Conversion of bridge notes and accrued interest | 6,361 | - | ||||||||
Conversion of warrant liability | 272 | - | ||||||||
Deferred rental expense for equipment exchange | 55 | - |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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BG Medicine, Inc. and Subsidiary
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. | Description of Business and Basis of Presentation |
Description of Business
BG Medicine, Inc. (“BG Medicine” or the “Company”) is a life sciences company focused on the discovery, development, and commercialization of novel, biomarker-based diagnostics for high-value market opportunities in healthcare that the Company identifies. The Company is developing and commercializing novel diagnostic tests that the Company’s management believes will provide clinicians with improved information to better detect and characterize disease states. The Company’s current focus is on developing products to address significant unmet needs in cardiovascular and other diseases. The Company’s lead product, the BGM Galectin-3 test for heart failure, is a diagnostic test for measuring galectin-3 levels in blood plasma or serum. The BGM Galectin-3 test received clearance from the U.S. Food and Drug Administration in November 2010 and obtained CE Mark in the European Union in October 2009. Galectin-3 testing services are currently being offered for use by clinicians in the United States and in certain countries in Europe.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States and in accordance with the rules and regulations of the SEC for interim financial information. Accordingly, they do not include all of the information and notes required by generally accepted accounting principles for complete financial statements. The interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s financial position at September 30, 2011 and results of operations and cash flows for the interim periods ended September 30, 2011 and 2010. These interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2010.
The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated through the date of issuance of these financial statements. The results of the nine months ended September 30, 2011 are not necessarily indicative of the results to be expected for the year ending December 31, 2011 or for any other interim period or for any other future year.
On February 3, 2011, the Company completed an initial public offering (IPO) of 5,750,000 shares of common stock at an offering price of $7.00 per share, resulting in net proceeds to the Company of approximately $34,818,000, after deducting underwriting discounts and offering costs. Effective upon the closing of the IPO, the Company’s outstanding shares of preferred stock were automatically converted into 9,541,931 shares of common stock. In addition, the principal and accrued interest related to all outstanding convertible bridge notes, totaling $6,361,000, were converted into 908,651 shares of common stock. In addition, the warrants to purchase the Company’s Series D preferred stock, which were accounted for as liabilities, converted into warrants to purchase the Company’s common stock. The new warrants to purchase the Company’s common stock are now qualified to be classified as equity, which resulted in $272,000 of carrying value related to the Series D preferred stock warrants being reclassified to additional paid-in capital.
Costs directly associated with the IPO, totaling $5,432,000, were recorded as a reduction of the IPO proceeds. These costs consisted of $2,817,000 in underwriting discounts, fees and commissions and $2,615,000 in professional fees, printing fees and miscellaneous expenses. At December 31, 2010, $2,229,000 of these costs were deferred.
The Company believes that the proceeds from the IPO together with its existing cash and cash equivalents and marketable securities will be sufficient to meet the Company’s anticipated cash requirements through 2012.
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BG Medicine, Inc. and Subsidiary
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
2. | Significant Accounting Policies |
Restricted Cash
Restricted cash of approximately $631,000 at September 30, 2011 consisted of cash received under the High Risk Plaque Initiative. This cash is to be used solely to fund the research and development efforts under this strategic initiative.
Marketable Securities
The Company invests any excess cash balances in short-term marketable securities, primarily securities management believes to be high-grade corporate notes and bonds. These investments are classified as available-for-sale. The average remaining maturity of our marketable securities as of September 30, 2011 was two months. Gains or losses on the sale of investments classified as available-for-sale, if any, are recognized on the specific identification method. Unrealized gains or losses are included in accumulated other comprehensive income (loss) as a separate component of stockholders’ deficit until the security is sold or until a decline in fair value is determined to be other than temporary. No unrealized gain or loss was recorded as of September 30, 2011 or December 31, 2010.
Inventory
Inventory is stated at the lower of cost or market. Costs are determined under the first-in, first-out (FIFO) method. Inventories at September 30, 2011 consisted of the following:
(in thousands) | September 30, 2011 | |||||||
Raw materials | $ | 46 | ||||||
Finished goods | 284 | |||||||
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Total inventories | $ | 330 | ||||||
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Intangible Assets
Intangible assets with aggregate costs of $750,000 at September 30, 2011 are comprised of completed technology that has been obtained under a perpetual license. The asset is being amortized over its economic life, which has been determined to be 10 years. Accumulated amortization totaled $273,000 and $209,000 at September 30, 2011 and December 31, 2010, respectively. Amortization expense for the nine months ended September 30, 2011 and 2010 was $63,000 and $63,000, respectively. The amortization expense for the next 5 years is expected to approximate $85,000 annually.
Net Loss Attributable to Common Stockholders Per Share
Basic net loss attributable to common stockholders per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted net loss attributable to common stockholders per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive common share equivalents outstanding for the period, determined using the treasury-stock method and the as-if-converted method, for convertible securities, if inclusion of these is not antidilutive. Because the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for all periods presented.
The following table summarizes the computation of basic and diluted net loss per share applicable to common stockholders for the three and nine months ended September 30, 2011 and 2010:
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
Net loss | $ | (4,881 | ) | $ | (4,487 | ) | $ | (12,848 | ) | $ | (13,839 | ) | ||||
Accretion of preferred stock | – | (260 | ) | (118 | ) | (769 | ) | |||||||||
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Net loss attributable to common stockholders | $ | (4,881 | ) | $ | (4,747 | ) | $ | (12,966 | ) | $ | (14,608 | ) | ||||
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Weighted average number of shares - basic and diluted | 19,344,905 | 2,994,549 | 16,925,693 | 2,963,626 | ||||||||||||
Net loss per share attributable to common stockholders - basic and diluted | $ | (0.25 | ) | $ | (1.59 | ) | $ | (0.77 | ) | $ | (4.93 | ) |
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BG Medicine, Inc. and Subsidiary
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For the three and nine months ended September 30, 2011 and 2010, the following potential common shares were excluded from the computation of diluted net loss per share attributable to common stockholders because they had an antidilutive impact due to the losses reported:
Three and Nine Months Ended September 30, | ||||||||
2011 | 2010 | |||||||
Options to purchase common stock | 3,202,391 | 2,442,662 | ||||||
Warrants to purchase common stock | 1,249,001 | 1,175,834 | ||||||
Warrants to purchase redeemable convertible preferred stock | - | 55,381 | ||||||
Conversion of redeemable convertible preferred stock | - | 9,541,931 | ||||||
Conversion of bridge notes and accrued interest | - | 588,689 |
3. Fair Value of Financial Instruments
The Company’s financial instruments consist of accounts receivable, cash equivalents, restricted cash, marketable securities, accounts payable, and certain warrant instruments. The carrying amounts of accounts receivable and accounts payable are considered reasonable estimates of their fair value, due to the short maturity of these instruments. The fair value of the other financial instruments is addressed below.
Accounting literature provides a fair value hierarchy, which classifies fair value measurements based on the inputs used in measuring fair value. These inputs include: Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs for which little or no market data exists, therefore requiring an entity to develop its own assumptions.
The following table represents information about the assets and liabilities measured at fair value on a recurring basis as of September 30, 2011 and December 31, 2010:
Description | Level 1 | Level 2 | Level 3 | Total | ||||||||||||
September 30, 2011 | (in thousands) | |||||||||||||||
Assets: | ||||||||||||||||
Cash equivalents | $ | 11,412 | $ | 1,201 | $ | - | $ | 12,613 | ||||||||
Restricted cash | 631 | - | - | 631 | ||||||||||||
Marketable securities: | ||||||||||||||||
Commercial paper | - | 7,698 | - | 7,698 | ||||||||||||
Corporate bonds | - | 5,050 | - | 5,050 | ||||||||||||
U.S. agency securities | - | 1,500 | - | 1,500 | ||||||||||||
Liabilities: | ||||||||||||||||
Warrant liability | $ | - | $ | - | $ | 11 | $ | 11 | ||||||||
December 31, 2010 | ||||||||||||||||
Assets: | �� | |||||||||||||||
Cash equivalents | $ | - | $ | 621 | $ | - | $ | 621 | ||||||||
Liabilities: | ||||||||||||||||
Warrant liability | $ | - | $ | - | $ | 248 | $ | 248 |
The Company’s cash equivalents and restricted cash consist of money market funds, commercial paper and other debt securities recorded at fair value, which approximates cost. Marketable securities consist of
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BG Medicine, Inc. and Subsidiary
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
commercial paper and other short-term debt instruments. At September 30, 2011 the Company’s money market funds have been classified as Level 1 because these investments are registered securities that are actively traded. At September 30, 2011 the Company’s debt securities were generally valued on the basis of valuations provided by third-party pricing services, as derived from such services’ pricing models. Inputs to the models may include, but are not limited to, reported trades, executable bid and asked prices, broker/dealer quotations, prices or yields of securities with similar characteristics, benchmark curves or information pertaining to the issuer, as well as industry and economic events. The pricing services may use a matrix approach, which considers information regarding securities with similar characteristics to determine the valuation for a security, and are considered Level 2 inputs.
The fair value of the preferred and common stock warrants was determined using the Black-Scholes option pricing method. The assumptions included in the Black-Scholes model were as follows:
Preferred Stock | Common Stock | |||||||||||
December 31, 2010 | September 30, 2011 | December 31, 2010 | ||||||||||
Weighted average risk-free interest rate | 2.71% | 1.08% | 2.48% | |||||||||
Expected dividend yield | 0% | 0% | 0% | |||||||||
Weighted-average remaining contractual term | 7.2 years | 5.5 years | 6.3 years | |||||||||
Expected volatility | 65%-66% | 70% | 65% | |||||||||
Fair value of underlying shares of stock | $4.20 | $3.55 | $7.00 |
The following table provides a roll-forward for the three and nine months ending September 30, 2011 and 2010 of the fair value of the warrant liability categorized with Level 3 inputs:
Warrant Liability | ||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
(in thousands) | ||||||||||||||||
Balance - Beginning of period | $ | 32 | $ | 523 | $ | 248 | $ | 471 | ||||||||
Increase (decrease) in fair value-recognized in operations as other expense (income) | (21) | (14) | 35 | 38 | ||||||||||||
Reclassification of warrant liability to additional paid in capital | - | - | (272) | - | ||||||||||||
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Balance - End of period | $ | 11 | $ | 509 | $ | 11 | $ | 509 | ||||||||
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The change in fair value of the warrants was primarily due to the passage of time and changes in the fair value of the equity instruments that underlie the warrants.
4. Bridge Notes
On March 30, 2010, the Company entered into a securities purchase agreement with certain then-existing stockholders for the sale of up to $6.0 million of bridge notes and warrants to purchase the Company’s common stock. The bridge notes bore interest at 12% annually and were due at any time upon the earliest of (i) demand by holders of 66 2/3% of the aggregate principal amount outstanding under the notes, (ii) the occurrence of a liquidation event, (iii) acceleration due to the occurrence of an event of default, or (iv) March 29, 2011. Upon the completion of the Company’s initial public offering in February 2011, the principal and accrued interest of the Company’s then-outstanding bridge notes were converted into 908,651 shares of common stock.
5. Warrants
During the three months and nine months ended September 30, 2011, the Company issued 106,334 shares of common stock upon the net exercise of warrants to purchase 106,645 shares of common stock. At September 30, 2011, there were warrants to purchase 1,249,001 shares of common stock outstanding with a weighted-average exercise price of $0.53 per share.
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Item 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
You should read the following in conjunction with our condensed consolidated financial statements and the related notes thereto that appear elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto and management’s discussion and analysis of financial conditions and results of operations included in our Annual Report on Form 10-K for the year ended December 31, 2010. In addition to historical information, the following discussion and analysis includes forward-looking information that involves risks, uncertainties and assumptions. Our actual results and the timing of events could differ materially from those anticipated by these forward-looking statements as a result of many factors, including those discussed under “Risk Factors” in Item 1A. of our Annual Report on Form 10-K for the year ended December 31, 2010.
Overview
We are a life sciences company focused on the discovery, development, and commercialization of novel, biomarker-based diagnostics for high-value market opportunities in healthcare that we identify. We believe that our tests will provide clinicians with improved information to better detect and characterize disease states. We are developing products to address significant unmet needs in cardiovascular and other diseases.
Our lead product, the BGM Galectin-3 test for heart failure, is a novel diagnostic test for measuring galectin-3 levels in blood plasma or serum. We are also developing our galectin-3 test for a second indication as a predictor of heart failure development in patients following acute coronary syndrome, a condition which includes heart attack or a serious form of cardiac chest pain called unstable angina.
We received 510(k) clearance from the FDA in November 2010 for a manual version of our BGM Galectin-3 test, and galectin-3 testing services are currently being offered for use by clinicians in the United States and in certain countries in Europe. This test is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. In addition, we obtained CE Mark in the European Union for the same manual version of the galectin-3 test in October 2009 and have begun limited sales and marketing activities in certain countries in Europe. The success of our business is largely dependent upon our ability to make our products widely available through existing automated systems and to obtain adequate reimbursement for our products. We have entered into worldwide development and commercialization agreements with Abbott Laboratories, Alere, bioMérieux and Siemens for the inclusion of our galectin-3 test on a variety of automated laboratory instruments and point-of-care instruments. Subject to clearance from the FDA, we expect automated instrument versions of this test to be available for commercial use in 2012. With respect to reimbursement of our galectin-3 tests, we have initiated the process to obtain an analyte-specific Current Procedural Terminology, or CPT, Code for measuring galectin-3 in plasma or serum, and based on the American Medical Association’s, or AMA’s, submission process, we expect to be eligible to obtain an analyte-specific CPT Code for galectin-3 testing beginning with the 2013 Clinical Laboratory Fee Schedule.
On May 11, 2011, we announced that we completed an important phase in the development of our AMIPredict diagnostic product candidate. AMIPredict is being developed to identify patients with a high risk of suffering heart attack or stroke within the next two to four years. The AMIPredict test is an in vitro diagnostic multivariate index assay that simultaneously measures multiple protein biomarkers in blood. The completed phase of development involved two milestones, the verification of AMIPredict’s performance in a second independent study, and the migration of the test from the original discovery platform to an automated, high-throughput platform. We are currently planning to conduct our validation study for AMIPredict in the fourth quarter of 2011. If we receive successful results in the validation study, we intend to submit a 510(k) premarket notification to the FDA for regulatory clearance of the AMIPredict test by year end.
In the coming years, we expect to devote most of our resources to the development and commercialization of our diagnostic product candidates, as well as the discovery of new biomarkers. Historically, we have generated revenue from our collaborative research and development agreements and biomarker discovery and analysis services agreements, but we do not expect to continue to receive significant revenue from these sources going forward. However, as we transition into a commercial organization, we expect to generate revenue from the sale of our products. As we continue our discovery, development and commercialization of diagnostic product candidates, we expect our research and development, sales and marketing, and general and administrative expenses to increase significantly.
During the three and nine months ended September 30, 2011, we incurred net losses of $4.9 million and $12.8 million, respectively. During the nine months ended September 30, 2011 we used cash in operating activities of $11.2 million. We expect to continue to incur losses and use cash in operating activities during the remainder of 2011 and beyond.
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In February 2011, we completed our initial public offering of 5,750,000 shares of common stock at $7.00 per share. We received net proceeds from the offering of approximately $34.8 million after deducting underwriter discounts and closing costs. Prior to our initial public offering in February 2011, we funded our operations primarily through private placements of preferred and common stock and debt financing, as well as through revenue generated from collaborative research and development and services agreements with pharmaceutical manufacturers, non-profit organizations and other entities. We expect to fund operations in the future through a combination of existing cash, sales of our products, private or public equity and debt financings, and payments from collaborators.
Material Factors Affecting Our Results of Operations and Financial Condition
We believe that the factors described in the following paragraphs have had and are expected to continue to have a material effect on our operational results and financial condition.
Revenue
To date, our revenue has been generated primarily through initiatives, collaborations and biomarker discovery and analysis services agreements. These services included the analysis of preclinical or clinical samples to identify biomarkers related to, for example, disease mechanism, drug response or toxicity. In some cases, we have retained rights to the biomarkers identified in the course of these agreements. Our revenue has tended to be concentrated, with arrangements with a limited number of large customers generating a significant percentage of revenue in any given year. During the remainder of 2011 and beyond, we do not expect to generate significant revenue from these collaborative research and development and services agreements. We expect to receive the substantial portion of any future revenue from sales of our diagnostic tests, subject to obtaining regulatory clearance or approval in the United States and other jurisdictions.
We initiated and are leading the HRP initiative for atherothrombotic cardiovascular disease such as heart attack and stroke. This initiative, which we began in 2006, is sponsored by Abbott, AstraZeneca, Merck, Philips and Takeda. To date, we have recognized $25.6 million in revenue from the contributions we received from the HRP initiative participant companies. In the nine months ended September 30, 2011, $1.0 million, or 82%, of our revenues were derived from the HRP initiative.
Cost of Revenue and Operating Expenses
We classify our cost of revenue and operating expenses into three categories: cost of revenue, research and development, and selling, general and administrative. Our operating expenses primarily consist of personnel costs, outside services, laboratory consumables and overhead, license fees, royalties on products, development costs, marketing program costs and professional fees. Personnel costs for each category of operating expenses include salaries, bonuses, employee benefit costs and stock-based compensation.
Cost of Revenue
Our cost of revenue to date consists primarily of research and development expenses incurred to support our initiatives, collaborative research and development agreements and biomarker discovery and analysis services agreements. These expenses include both outside services and internal personnel costs, laboratory consumables, license fees and overhead expenses. During the remainder of 2011, cost of revenue is expected to consist of product costs for our galectin-3 test and costs incurred to support the HRP initiative.
Research and Development Expenses
We incur research and development expenses in connection with our internal biomarker discovery and development efforts. Our research and development expenses consist primarily of direct personnel costs, fees for consultants and outside services, laboratory consumables and overhead expenses. We use consultants and outside services to provide expertise or services which we do not have.
Selling, General and Administrative Expenses
Selling expenses consist primarily of personnel-related expenses for employees engaged in market development and commercialization activities for our galectin-3 test. We expect increases in our selling and marketing expenses during the remainder of 2011 and beyond as we hire additional personnel, establish our sales force, and conduct marketing activities for the commercialization of our product candidates.
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General and administrative expenses consist primarily of personnel-related expenses, occupancy expenses and professional fees, such as legal, auditing and tax service. We expect that our general and administrative expenses will increase significantly as we expand our business operations to accommodate new product offerings and add commercial infrastructure. As a result of our initial public offering in February 2011, we anticipate increases in general and administrative expense relating to operating as a public company. These increases will likely include regulatory, legal, directors’ and officers’ insurance premiums, investor relations services, and accounting and financial reporting expenses.
Provision for Income Taxes
We have historically generated operating losses in all jurisdictions in which we may be subject to income taxes. As such, we have not incurred any income taxes. We have accumulated significant net operating losses and other deferred tax assets. Because of our history of losses and the uncertainty as to the realization of those deferred tax assets, a full valuation allowance has been recorded. We do not expect to report a benefit for our deferred tax assets until we have a history of earnings, if ever, that would support their future realization.
Critical Accounting Policies and Significant Judgments and Estimates
A summary of our significant accounting policies is contained in the notes to our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2010. There have been no material changes to those policies during the three months ended September 30, 2011.
Results Of Operations
Comparison of the three months ended September 30, 2011 and 2010
Revenue
Revenue increased by 83%, or $81,000, to $179,000 in the three months ended September 30, 2011 from $98,000 in the same period in 2010. This increase was primarily due to revenue being recognized on the BGM Galectin-3 test in the three months ended September 30, 2011. We expect to receive only nominal revenue from the HRP initiative and other service agreements for the balance of 2011 and beyond. Commercial revenues from sales of our diagnostic products are expected to increase as the automated versions of the galectin-3 test become available for commercial use and as we obtain an analyte-specific CPT Code for galectin-3.
Cost of Revenue and Operating Expenses
Cost of Revenue
Cost of revenue decreased by 51%, or $88,000, to $84,000 in the three months ended September 30, 2011 as compared to the same period in 2010. The decrease in cost of revenue was primarily attributable to lower levels of activity associated with Phase II of the HRP initiative.
Research and Development Expenses
Research and development expenses increased by 15%, or $255,000, to $1.9 million in the three months ended September 30, 2011 as compared to the same period in 2010. The increase was primarily due to an increase in personnel-related costs and activity associated with our internal biomarker discovery and development efforts, primarily related to our galectin-3 automated platform programs and our AMIPredict program.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by 70%, or $1.3 million, to $3.1 million in the three months ended September 30, 2011 as compared to the same period in 2010. Marketing expenses increased by $848,000 primarily due to personnel-related costs and medical education programs associated with our galectin-3 product. General and administrative expenses increased by $422,000 primarily due to expenses related to being a public company, including directors’ and officers’ insurance, filing fees, and board of director fees.
Interest Income
Interest income increased by $9,000, to $10,000 in the three months ended September 30, 2011 as compared to the same period in 2010. This was due to interest being earned on larger balances of cash equivalents and investments held for sale purchased with the proceeds of the Company’s initial public offering in February 2011.
Interest Expense
Interest expense and other financing costs decreased by 100%, or $945,000, in the three months ended September 30, 2011 as compared to the same period in 2010. Interest expense and other financing costs in the three months
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ended September 30, 2010 were comprised of the non-cash expenses arising from the issuance of warrants for the bridge notes and term loans of $925,000, as well as cash interest from the term loans of $20,000. Interest expense is expected to remain lower for the balance of 2011 than in 2010 as no debt has been outstanding since the closing of our initial public offering in February 2011.
Income Taxes
The provision for income taxes was zero in the three months ended September 30, 2011 and 2010 due to the losses incurred and full valuation allowance recognized on the Company’s deferred tax assets because the Company cannot conclude that it is more likely than not that the deferred tax assets will be realized.
Comparison of the nine months ended September 30, 2011 and 2010
Revenue
Revenue increased by 102%, or $635,000, to $1.3 million in the nine months ended September 30, 2011 from $620,000 in the same period in 2010. This increase was primarily due to the recognition of revenue from a new agreement under the HRP initiative, which resulted in $700,000 of revenue realized upon the transfer of data which occurred in the nine months ended September 30, 2011. We expect to receive only nominal revenue from the HRP initiative and other service agreements for the balance of 2011 and beyond. Commercial revenues from sales of our diagnostic products are expected to increase as the automated versions of the galectin-3 test become available for commercial use and as we obtain an analyte-specific CPT Code for galectin-3.
Cost of Revenue and Operating Expenses
Cost of Revenue
Cost of revenue decreased by 34%, or $222,000, to $428,000 in the nine months ended September 30, 2011 as compared to the same period in 2010. The decrease in cost of revenue was primarily attributable to lower levels of activity associated with Phase II of the HRP initiative and other service agreements. The cost of revenue as a percentage of revenues in 2011 was significantly less than in 2010 because the cost of the data transferred resulting in $700,000 of revenue was de minimis.
Research and Development Expenses
Research and development expenses increased by 7%, or $414,000, to $6.0 million in the nine months ended September 30, 2011 as compared to the same period in 2010. The increase was primarily due to an increase in personnel-related costs and activity associated with our internal biomarker discovery and development efforts primarily related to our galectin-3 automated platform programs and our AMIPredict program.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by 22%, or $1.3 million, to $7.6 million in the nine months ended September 30, 2011 as compared to the same period in 2010. Marketing expenses increased by $778,000 primarily due to personnel-related costs and medical education programs associated with our galectin-3 product. General and administrative expenses increased by $565,000 primarily due to expenses related to being a public company, including directors’ and officers’ insurance, filing fees, and board of director fees.
Interest Income
Interest income increased by $21,000, to $25,000 in the nine months ended September 30, 2011 as compared to the same period in 2010. This was due to interest being earned on larger balances of cash equivalents and investments held for sale purchased with the proceeds of the Company’s initial public offering in February 2011.
Interest Expense
Interest expense and other financing costs decreased by 95%, or $1.9 million, to $90,000 in the nine months ended September 30, 2011 as compared to the same period in 2010. Interest expense and other financing costs in the nine months ended September 30, 2010 were comprised of the non-cash expenses arising from the issuance of warrants for the bridge notes and term loans of $1.8 million, as well as cash interest from the term loans of $104,000. Interest expense is expected to remain lower for the balance of 2011 than in 2010 as no debt has been outstanding since the closing of our initial public offering in February 2011.
Income Taxes
The provision for income taxes was zero in the nine months ended September 30, 2011 and 2010 due to the losses incurred and full valuation allowance recognized on the Company’s deferred tax assets because the Company cannot conclude that it is more likely than not that the deferred tax assets will be realized.
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Liquidity and Capital Resources
Sources of Liquidity
As of September 30, 2011, we had $27.3 million of cash and cash equivalents and marketable securities, and working capital of $23.9 million. We also had $631,000 of restricted cash from funding received under the HRP initiative.
Prior to our initial public offering in February 2011, our primary sources of liquidity were funds generated from our sale of shares of our preferred stock, debt financings, and cash receipts from our research and development collaborations and service agreements.
In February 2011, we raised $40.3 million in gross proceeds from the sale of 5,750,000 shares of our common stock in our initial public offering at $7.00 per share. The net proceeds from the offering were approximately $34.8 million after deducting underwriter discounts and closing costs and are being used to support our operating activities.
Net Cash Used
For the nine months ended September 30, 2011, we used cash in operating activities of $11.2 million, which reflects the net loss incurred totaling $12.8 million, offset by $1.6 million of non-cash charges and changes in working capital balances. Cash flows used in investing activities of $14.3 million consisted primarily of purchases of marketable securities, and to a lesser extent, purchases of property and equipment. Net cash flows provided by financing activities were $36.2 million, which included net proceeds from the initial public offering, offset by $100,000 from the repayment of our term loan. As a result, we had a net increase in cash for the nine months ended September 30, 2011 of $10.7 million. However, for the three months ended September 30, 2011, we used $4.0 million of cash to support our operations and would expect the use of cash to continue.
For the nine months ended September 30, 2010, we used cash in operating activities of $9.4 million, which reflects the net loss incurred totaling $13.8 million, offset by $4.4 million of non-cash charges and changes in working capital balances. Cash flows provided by investing activities of $2.0 million consisted of net proceeds from the purchase and sale of marketable securities. Net cash flows provided by financing activities were $2.0 million, which included proceeds from the issuance of convertible promissory notes of $4.0 million offset by $2.1 million from the repayment of our term loan and payment of the transaction fees related to our initial public offering. As a result, we had a net decrease in cash for the nine months ended September 30, 2010 of $5.5 million.
Funding Requirements
To date, we have generated revenue primarily through the provision of services to third parties in connection with our initiatives, collaborations and biomarker discovery and analysis services agreements. However, as we transition into a commercial organization, we expect to generate revenue from the sale of our products and do not expect to generate significant service-based revenue of this kind in the future under collaborative research and development and services agreements. We have generated only a limited amount of product revenue since our inception but expect that revenue from the sale of our testing products will increase as the automated versions of the galectin-3 test become available for commercial use and as we obtain an analyte-specific CPT Code for galectin-3. During the three and nine months ended September 30, 2011, we incurred net losses totaling $4.9 million and $12.8 million, respectively, and used cash in operating activities totaling $4.0 million and $11.2 million, respectively. We expect to continue to incur losses and use cash in operating activities during the remainder of 2011 and beyond. We expect to use our existing cash to fund operations, including continued research and product development, sales and marketing related to our launch of our first commercial product, capital expenditures, and existing debt service costs. We believe that our existing cash and cash equivalents and marketable securities will be sufficient to meet our anticipated cash requirements through 2012. This belief is based on our current operations and planned activities at normal levels and does not assume any cash inflows from partnerships, disposition of additional non-core assets or successful completion of any additional equity or debt financings.
If we are not able to generate significant revenues from sales of our galectin-3 tests by the end of 2012, we will need to raise funds to continue our operations. We may consider any of the following options:
Ø | partnering opportunities with pharmaceutical or biotechnology companies to pursue the development of our product candidates as companion diagnostic tests to their therapeutic products; |
Ø | license, sublicense, or other sources of financing relating to the development programs of our product candidates and other intellectual property; or |
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Ø | sales of equity or debt securities or the incurrence of commercial debt. |
Such financing, licensing and partnering arrangement may not be available to us on acceptable terms, if at all. If we are unable to obtain financing or enter into licensing or partnering arrangements on acceptable terms at that time, we will be required to implement aggressive cost reduction strategies. The most significant portion of our research and development expenses, as well as some portion of sales and marketing expenses, are discretionary and are in connection with development and commercial launch of our galectin-3 test. These cost reduction strategies could reduce the scope of the activities related to these development and commercialization activities and could harm our long-term financial condition and results of operations.
Our forecast of the period of time through which our financial resources will be adequate to support our operations, the costs to complete development of product candidates and the cost to commercialize our future products are forward-looking statements and involve risks and uncertainties, and actual results could vary materially and negatively as a result of a number of factors, including the factors discussed in the “Risk Factors” section contained in Item 1A. of our Annual Report on Form 10-K for the year ended December 31, 2010. We have based these estimates on assumptions that may prove to be incorrect, and we could utilize our available capital resources sooner than we currently expect. Our future liquidity and capital funding requirements will depend on numerous factors, including:
Ø | the rate of progress and cost of our commercialization activities; |
Ø | the success of our research and development efforts; |
Ø | the expenses we incur in marketing and selling our products; |
Ø | the revenue generated by sales of our galectin-3 test and any future products; |
Ø | the emergence of competing or complementary products; |
Ø | the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and |
Ø | the terms and timing of any collaborative, licensing or other arrangements that we have or may establish. |
Contractual Obligations and Commitments
There have been no material changes to our contractual obligations and commitments set forth under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations and Commitments” in our Annual Report on Form 10-K for the year ended December 31, 2010, except that we repaid our term loan in full, including accrued interest, in the amount of $101,000 in January 2011.
Off Balance Sheet Arrangements
As of September 30, 2011, we did not have any off balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K.
Special Note Regarding Forward-Looking Statements
The Securities and Exchange Commission encourages companies to disclose forward-looking information so that investors can better understand a company’s future prospects and make informed investment decisions. This Quarterly Report on Form 10-Q contains such “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and other important factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
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Ø | our estimates of future performance, including the commercialization of our galectin-3 test and timing of the launch of our product candidates; |
Ø | our ability to market, commercialize and achieve market acceptance for our galectin-3 test and any of our product candidates that we are developing or may develop in the future; |
Ø | our ability to conduct the clinical studies required for regulatory clearance or approval and to demonstrate the clinical benefits and cost-effectiveness to support commercial acceptance of our product candidates; |
Ø | the timing, costs and other limitations involved in obtaining regulatory clearance or approval for any of our product candidates; |
Ø | the potential benefits of our galectin-3 test and our product candidates over current medical practices or other diagnostics; |
Ø | willingness of third-party payors to reimburse for the cost of our tests; |
Ø | estimates of market sizes and anticipated uses of our galectin-3 test and our product candidates; |
Ø | our ability to enter into collaboration agreements with respect to our galectin-3 test and our product candidates and the performance of our collaborative partners under such agreements; |
Ø | our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; |
Ø | the expected timing, progress or success of our research and development and commercialization efforts; |
Ø | our ability to successfully obtain sufficient supplies of samples for our biomarker discovery and development efforts; |
Ø | our estimates regarding anticipated operating losses, future revenue, expenses, capital requirements and our needs for additional financing; and |
Ø | our ability to obtain additional financing on acceptable terms, if at all. |
Words such as “may,” “anticipate,” “estimate,” “expects,” “projects,” “intends,” “plans,” “believes” and words and terms of similar substance used in connection with any discussion of future operating or financial performance, identify forward-looking statements. All forward-looking statements are management’s present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to those set forth under the heading “Risk Factors” contained in Item 1A. of our Annual Report on Form 10-K for the year ended December 31, 2010.
In light of these assumptions, risks and uncertainties, the results and events discussed in the forward-looking statements contained in this Quarterly Report on Form 10-Q or in any document incorporated by reference might not occur. Stockholders are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q. We are not under any obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise. All subsequent forward-looking statements attributable to BG Medicine, Inc. or to any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section.
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Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk is limited to our cash and cash equivalents and marketable securities, all of which have maturities of less than one year. The goals of our investment policy are preservation of capital, fulfillment of liquidity needs and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk. To achieve our goals, we maintain a portfolio of cash equivalents and investments in a variety of securities that management believes to be of high credit quality. We currently do not hedge interest rate exposure. Because of the short-term maturities of our investments, we do not believe that an increase in market rates would have a material negative impact on our results of operations or financial position.
We do not have any material foreign currency exposure and do not hedge any foreign currency exposures.
Item 4. CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures. Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Form 10-Q, have concluded that, based on such evaluation, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
(b) Changes in Internal Controls. There were no changes in our internal control over financial reporting identified in connection with the evaluation of such internal control that occurred during the quarter ended September 30, 2011 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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Item 1. | LEGAL PROCEEDINGS |
We are not currently a party to any material legal proceedings.
Item 1A. | RISK FACTORS |
There have been no material changes to the risk factors discussed in Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2010.
Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(a) | Unregistered Sales of Equity Securities |
Not applicable.
(b) | Use of Proceeds |
We registered shares of our common stock in connection with our initial public offering under the Securities Act. The registration statement on Form S-1 (File No. 333-164574), or the Registration Statement, filed in connection with our initial public offering was declared effective by the Securities and Exchange Commission on February 3, 2011. The net offering proceeds received by us, after deducting underwriting discounts and commissions and expenses incurred in connection with the offering, were approximately $34.8 million.
As of September 30, 2011, $7.5 million of the net proceeds of the offering had been used primarily for general working capital purposes, including the commercialization of our BGM Galectin-3 test for heart failure and related sales and marketing expenses incident thereto. The net proceeds from the offering have been invested in our operating account, bank time deposits, money market funds and short term marketable securities. There has been no material change in the expected use of the net proceeds from our initial public offering as described in our final prospectus dated February 3, 2011, filed with the Securities and Exchange Commission pursuant to Rule 424(b)(1).
(c) | Issuer Purchases of Equity Securities |
We did not repurchase any of our equity securities during the quarter ended September 30, 2011.
Item 3. | DEFAULTS UPON SENIOR SECURITIES |
None.
Item 4. | (REMOVED AND RESERVED) |
Item 5. | OTHER INFORMATION |
On November 3, 2011, we entered into a consulting agreement with our Executive Chairman, Stéphane Bancel, the terms of which are consistent with the terms disclosed in our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 29, 2011, except that our Compensation Committee later determined to commence payment of Mr. Bancel’s salary as of October 1, 2011 rather than January 1, 2012 due to an increase in his responsibilities earlier than originally anticipated. A copy of the consulting agreement is filed as Exhibit 10.1 to this Quarterly Report on Form 10-Q and incorporated by reference herein.
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Item 6. | EXHIBITS |
(a) Exhibits
Exhibit Number | Exhibit Description | Filed with this Report | ||
10.1* | Consulting Agreement between the Company and Stéphane Bancel dated November 3, 2011. | X | ||
31.1 | Certification of the Company’s Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | X | ||
31.2 | Certification of the Company’s Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | X | ||
32 | Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | ||
101 @ | The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, formatted in XBRL (eXtensible Business Reporting Language); (i) Unaudited Condensed Consolidated Balance Sheets as of September 30, 2011 and December 31, 2010, (ii) Unaudited Condensed Consolidated Statements of Operations for the three and nine-month periods ended September 30, 2011 and 2010, (iii) Unaudited Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ (Deficit) Equity for the nine-month period ended September 30, 2011, (iv) Unaudited Condensed Consolidated Statements of Cash Flows for the nine-month periods ended September 30, 2011 and 2010, and (iv) Notes to Unaudited Condensed Consolidated Financial Statements. | X |
(*) Management contract or compensatory plan or arrangement.
@ Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.
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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.
BG MEDICINE, INC. | ||||
Date: November 7, 2011 | By: | /s/ Pieter Muntendam, M.D. | ||
Pieter Muntendam, M.D. | ||||
President and Chief Executive Officer | ||||
Date: November 7, 2011 | By: | /s/ Michael W. Rogers | ||
Michael W. Rogers | ||||
Executive Vice President, Chief Financial Officer and Treasurer |