Liquidity, Capital Resources and Recent Developments | Liquidity, Capital Resources and Recent Developments Liquidity and Capital Resources As of September 30, 2015 , the Company has incurred net losses of $446.8 million since inception, and has funded those losses primarily through the sale and issuance of equity securities and secondarily through the issuance of debt. While the Company is currently in the commercialization stage of operations, the Company has not yet achieved profitability and anticipates that it will continue to incur net losses in the foreseeable future. The Company had cash and cash equivalents of $16.3 million, of which $4 million is restricted cash as of September 30, 2015 and net cash used in operating activities of $20.6 million for the nine months period ended September 30, 2015 . In addition, our current term loan facility (“2015 Loan Agreement”) provides for minimum quarterly amortization ratios of (i) the aggregate of our cash operating expenses, cash interest expenses and capital expenditures, to (ii) our gross profits. The Company did not meet the required amortization ratio of 3.5 for the quarter ended September 30, 2015, and may not achieve the required amortization ratio of 2.6 for the quarter ending December 31, 2015. If the Company fails to satisfy the required amortization ratio for any two out of three successive quarters, the date on which the first amortization payment is due under the term loan facility would accelerate to the next following payment date, and the minimum quarterly amortization rate would increase to approximately $3.3 million, resulting in a payoff of the current amount outstanding under the term loan facility in six fiscal quarters. Management is uncertain that its current and anticipated cash resources will be sufficient to support currently forecasted operations through at least the next twelve months, and therefore, the Company will need additional debt or equity financing in the future to execute its business plan and to be able to continue as a going concern. Capital outlays and operating expenditures may increase over the next twelve months as the Company expands its infrastructure, manufacturing capacity and research and development activities to support commercialization of our products. These capital outlays and operating expenditures would be curtailed if the Company is not successful in raising additional funds. Many of the aspects of the Company’s forecasts involve management’s judgments and estimates that include factors that could be beyond our control and actual results could differ. These and other factors could cause our forecasted plans to be unsuccessful which could have a material adverse effect on our operating results, financial condition, and liquidity. Term Loan Facility with NSPH Funding LLC and SWK Funding LLC On May 14, 2015 (the "Closing Date") the Company entered into a Loan and Security Agreement ("2015 Loan Agreement") with NSPH Funding LLC, an affiliate of Life Sciences Alternative Funding, LLC, and SWK Funding LLC, as lenders (together, the “New Lenders”) providing for the New Lenders to advance term loans in an aggregate amount of up to $30 million (the “Loan”) to the Company. NSPH Funding LLC also agreed to act as agent under the loan facility (the “Collateral Agent”). Also on the Closing Date, concurrent with the Company's entry into the 2015 Loan Agreement, the Company drew down $20.0 million of the Loan, terminated its existing debt facility, and repaid approximately $8.9 million in full satisfaction of all outstanding liabilities and obligations under such prior debt facility. The remaining $10 million of the New Lenders’ commitment (the “Second Advance”) can be drawn upon satisfaction of certain other conditions on or before May 14, 2016, including the Company achieving trailing six month revenue of at least $12 million during any consecutive six month period; and the Company selling no less than 100 cumulative new units during any 12 month period starting January 1, 2015. There can be no assurance that the Company will achieve the foregoing requirements in order to be able to draw the Second Advance. Under the original terms of the 2015 Loan Agreement, the Company was required to (i) raise at least $6.0 million in net proceeds from either equity financings or licensing or strategic partnership transactions on or before January 14, 2016 (the “Capital Requirement”), and (ii) maintain a minimum of $3.0 million in accounts that are subject to a control agreement in favor of the Collateral Agent. As further described below, on June 11, 2015 the Company completed a registered direct offering of series B preferred stock and warrants to purchase shares of common stock for approximately $4.0 million in net proceeds to the Company. On July 29, 2015 the Company and the New Lenders entered into an amendment to the 2015 Loan Agreement (the “Amendment”) that reduced the Capital Requirement to $4.0 million and included the Lenders’ acknowledgement that the Capital Requirement has been fully satisfied. The Amendment also modified the minimum account balance in the Company’s accounts that are subject to a control agreement in favor of the Collateral Agent, by increasing the minimum balance to $4.0 million concurrent with the entry into the Amendment and providing that it shall increase to $5.0 million after the earlier of the funding of the Second Advance or December 31, 2016. Under the 2015 Loan Agreement, the Company will pay interest only (the “Interest Only Period”) on a quarterly basis until the earlier of (i) three years from the Closing Date or (ii) the Company’s failure to satisfy a ratio of certain expenses to gross profit as set forth in the 2015 Loan Agreement. At the conclusion of the Interest Only Period, the Company will be required to repay a portion of the outstanding principal and all accrued interest on a quarterly basis through the maturity date of the Loan depending on certain revenue thresholds established under the 2015 Loan Agreement, but subject to certain caps on the principal amount to be paid per fiscal quarter as established under the 2015 Loan Agreement. The term of the Loan (including the second tranche, if advanced) is six years , or earlier if the Company fails to satisfy a ratio of certain expenses to gross profits or if an event of default occurs, all as set forth in the 2015 Loan Agreement. Interest on the Loan will accrue at a rate of 11.50% per annum plus the greater of (i) 1.00% or (ii) LIBOR. The interest rate will increase by 5.00% upon the occurrence and during the continuation of an event of default under the 2015 Loan Agreement. A facility fee for the Loan of $0.45 million was paid upon execution of the 2015 Loan Agreement. A final fee equal to 5.00% of the aggregate principal amount of the Loan funded (without regard to prepayments during the term of the Loan) at such time will be due upon any repayment of the Loan or acceleration of the Loan. In the event that the Loan is prepaid or accelerated for any reason prior to the third anniversary of the Closing Date, a prepayment fee equal to 2.00% of the principal amount prepaid (if prior to the first anniversary of the Effective Date) or 1.00% (if after the first anniversary but prior to the third anniversary of the Closing Date) is also payable. The Loan is secured by substantially all of the assets of the Company, including, without limitation, the Company’s intellectual property. The 2015 Loan Agreement includes customary negative covenants that restrict the Company from incurring additional debt, paying dividends, disposing of material assets (except for sales in the ordinary course). The 2015 Loan Agreement also provides for customary events of default, including among others, nonpayment of principal, interest, fees or other amounts; material inaccuracy of representations; material adverse change; violation of covenants; and bankruptcy or insolvency of the Company. If an event of default occurs under the 2015 Loan Agreement, the entire outstanding balance would become immediately due and payable upon notice in certain instances from the Collateral Agent or New Lenders (or on an automatic basis in the event of a bankruptcy or insolvency event). As consideration for the funding of the Loan and the New Lenders’ commitment thereunder, on the Closing Date the Company issued warrants to the New Lenders to acquire an aggregate of up to 1,000,000 shares of common stock, par value $0.01 (the “Common Stock”) with an exercise price of $0.01 per share and an expiration date that is ten years from the date of the 2015 Loan Agreement (the “Lender Warrants”). At the time of issuance, the relative fair value of the warrants was estimated at $3.9 million using the Black-Scholes model and recorded as a debt discount. Series A Convertible Preferred Stock On May 11, 2015, the Company issued $4.4 million of series A convertible preferred stock (the "Series A Preferred Stock") (which are convertible into a total of 1,168,659 shares of common stock at a conversion price of $3.765 ) and warrants to purchase shares of common stock exercisable for up to 1,168,659 additional shares of common stock, in the aggregate at exercise price of $3.65 per share (the "Series A Investor Warrants"). In connection with the Series A Offering, and as partial payment of the placement agent’s fees in connection therewith, the Company issued to the placement agent and certain of its principals warrants to purchase an aggregate of 70,120 shares of common stock at an exercise price of $4.45 per share (the “Series A Placement Agent Warrants, and together with the Series A Investor Warrants, the “Series A Warrants”). The Series A Warrants are exercisable for 4.5 to 5 years commencing November 14, 2015. At the time of issuance, the relative fair value of the Series A Investor Warrants was estimated at $1.6 million using the Black-Scholes model and recorded as issuance costs. The Series A Preferred Stock is perpetual and does not have a required dividend right or voting rights and has a liquidation preference of $0.01 per share. As of September 30, 2015, all 4,400 shares of Series A Preferred Stock had been converted into 1,168,659 shares of common stock. The Company completed the issuance and sale of the Series A Preferred Stock and Series A Warrants on May 14, 2015. Net proceeds from the Series A Offering after placement agent fees and other offering expenses were approximately $4.0 million. Series B Convertible Preferred Stock On June 8, 2015, the Investors waived the Lock-Up Restriction and the Company issued $4.4 million of series B convertible preferred stock (the “Series B Preferred Stock”) (which are convertible into a total of 1,203,800 shares of common stock at a conversion price of $3.655 ) and warrants to purchase shares of common stock exercisable for up to 1,203,800 additional shares of common stock, in the aggregate at an exercise price of $3.54 per share (the “Series B Investor Warrants”). In connection with the Series B Offering, and as partial payment of the placement agent’s fees in connection therewith, the Company issued to the placement agent and certain of its principals warrants to purchase an aggregate of 72,230 shares of common stock at an exercise price of $3.54 per share (the “Series B Placement Agent Warrants, and together with the Series B Investor Warrants, the “Series B Warrants”). The Series B Warrants are exercisable for 4.5 to 5 years commencing December 11, 2015. At the time of issuance, the relative fair value of the Series B Investor Warrants was estimated at $1.6 million using the Black-Scholes model and recorded as issuance costs. The Series B Preferred Stock is perpetual and does not have a required dividend right or voting rights and has a liquidation preference of $0.01 per share. As of September 30, 2015, all 4,400 shares of Series B Preferred Stock has been converted into 1,203,800 shares of common stock. The Company completed the issuance and sale of the Series B Preferred Stock and Series B Warrants on June 11, 2015. Net proceeds from the Series B Offering after placement agent fees and other offering expenses were approximately $4.0 million. The Lender Warrants, Series A Warrants, and Series B Warrants can be settled in shares of our common stock by cashless exercise in lieu of payment of the exercise price at the option of the holder. The warrants contain no mandatory redemption features and no repurchase obligations requiring the transferring of assets and are for a fixed number of shares, except for customary anti-dilution adjustments. Under the original terms of the 2015 Loan Agreement, the Company was required to (i) raise at least $6.0 million in net proceeds from either equity financings or licensing or strategic partnership transactions on or before January 14, 2016 (the “Capital Requirement”), and (ii) maintain a minimum of $3.0 million in accounts that are subject to a control agreement in favor of the Collateral Agent. On June 11, 2015 the Company completed a registered direct offering of series B preferred stock and warrants to purchase shares of common stock for approximately $4.0 million in net proceeds to the Company. On July 29, 2015 the Company and the New Lenders entered into an amendment to the 2015 Loan Agreement (the “Amendment”) that reduced the Capital Requirement to $4.0 million and included the Lenders’ acknowledgement that the Capital Requirement has been fully satisfied. The Amendment also modified the minimum account balance in the Company’s accounts that are subject to a control agreement in favor of the Collateral Agent, by increasing the minimum balance to $4.0 million concurrent with the entry into the Amendment and providing that it shall increase to $5.0 million after the earlier of the funding of the Second Advance or December 31, 2016. |