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Need to Raise Additional Capital
12 Months Ended
Dec. 31, 2015
Text Block [Abstract]  
Need to Raise Additional Capital

2.    Need to Raise Additional Capital

We have incurred significant losses from operations since inception and expect losses to continue for the foreseeable future. As of December 31, 2015, we had cash, cash equivalents, marketable securities and restricted cash (Refer to Note 3 - Summary of Significant Accounting Policies) of $7,755,000 and a working capital deficiency of $47,206,000. The working capital deficiency is primarily the result of the classification of our royalty securitization financing as a current liability (Refer to Note 8 - Financing Obligations). Our operating and capital plans call for cash expenditures to exceed these amounts for the next twelve months.

We plan to finance our operations through partnership or licensing collaborations, the sale of equity securities, debt arrangements, a potential sale or disposition of one or more corporate assets or a strategic business combination or partnership, and we have engaged Guggenheim Securities, LLC to assist us in exploring such strategic options to enhance stockholder value. Such funding or potential transaction may not be available or may be on terms that are not favorable to us. Our inability to raise capital as and when needed could have a negative impact on our financial condition and our ability to continue as a going concern. If we become unable to continue as a going concern, we may have to liquidate our assets, and might realize significantly less than the values at which they are carried on our financial statements, and stockholders may lose all or part of their investment in our common stock. Based on our available cash resources, the additional $1,000,000 drawn in March 2016 under the Ferrer Note (Refer to Note 8 - Financing Obligations) and our expected cash usage, we estimate that we have sufficient capital resources to meet our anticipated cash needs until the end of April 2016. Also, as discussed in Note 12 - Restructuring, we have changed our commercial manufacturing strategy and during the third quarter of 2015, we suspended our commercial production after completing all ADASUVE production under our license and supply agreements with our collaborator, Ferrer, and our previous collaborator for ADASUVE in the United States, Teva Pharmaceuticals USA, Inc., or Teva.

In February 2016, we entered into a definitive agreement with Teva whereby we reacquired the ADASUVE commercial U.S. rights and restructure our obligations under the outstanding Note from Teva. The agreement is intended to allow us to continue to provide ADASUVE product to patients and health care providers. The Amended Note with Teva, or the Amended Teva Note, provides that (i) we issue  2,172,886 shares of our common stock to Teva pursuant to a stock issuance agreement as consideration for a reduction in the outstanding balance of the Amended Teva Note by $5,000,000 and forgiveness of all accrued and unpaid interest under the Amended Teva Note; (ii) we are obligated to repay the remaining $20,000,000 outstanding balance of the Amended Teva Note in four annual consecutive payments of $5,000,000 beginning in the first calendar year following the calendar year in which the aggregate annual net sales of ADASUVE and any other Staccato enabled products first reach $50,000,000 in the United States; and (iii) we have ability to prepay the outstanding balance of the Amended Teva Note. We are further evaluating the impact of these changes on our consolidated financial position, results of operations and cash flows.

The significant uncertainties surrounding any revenue from sales of ADASUVE, including royalties and milestone payments from our present and future collaborations, clinical development timelines and costs and the need to raise a significant amount of capital raises substantial doubt about our ability to continue as a going concern for a reasonable period of time. These consolidated financial statements have been prepared with the assumption that we will continue as a going concern and will be able to realize our assets and discharge our liabilities in the normal course of business and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from our inability to continue as a going concern.  In order to mitigate the risk related with this uncertainty, we plan to issue debt or additional shares of our common stock for cash and services or enter into additional collaborations or a strategic transaction during the next twelve months.  There is no assurance we will able to raise sufficient capital on acceptable terms, or at all, to continue commercialization efforts for ADASUVE, continue development of our product candidates or to otherwise continue operations or that we will be able to execute any strategic transaction. Even if we are able to source additional capital, we may be forced to significantly reduce our operations if our business prospects do not improve. If we are unable to source additional capital, we may be forced to shut down operations altogether.

In February 2016, we entered into the Letter of Intent with Ferrer with respect to the Transaction. The Letter of Intent does not constitute a binding agreement to consummate such acquisition and it entitles both us and Ferrer to terminate discussions at any time in our or Ferrer's sole discretion. Additionally we can, at our discretion, enter into discussions with third parties and continue to explore strategic options. We continue to have discussions with Ferrer regarding a transaction. There can be no assurance that such potential transaction will be agreed to or consummated. The entering into the Letter of Intent follows exploration of strategic options that we announced previously. In September 2015, we announced that we had retained Guggenheim Securities, LLC to assist in exploring strategic options to enhance stockholder value, including a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions. Our Board of Directors will review and carefully evaluate the terms of the potential Transaction with our financial and legal advisors.