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Need to Raise Additional Capital
3 Months Ended
Mar. 31, 2016
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 March 31, 2016, we had cash and cash equivalents of $4,502,000 and a working capital deficiency of $52,909,000. The working capital deficiency is primarily the result of the classification of our royalty securitization financing as a current liability. Our operating and capital plans call for cash expenditures to exceed cash and cash equivalent balances 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 $2,300,000 drawn in April and May 2016 under that certain promissory note we issued to Ferrer as amended, or the Ferrer Note, and our expected cash usage, we estimate that we have sufficient capital resources to meet our anticipated cash needs until the end of June 2016.

In February 2016, we entered into a definitive agreement with Teva Pharmaceuticals USA, Inc. or Teva, whereby (i) we reacquired the ADASUVE commercial U.S. rights that we had licensed to Teva under that certain License and Collaboration Agreement we executed with Teva in May 2013, or the Teva Amendment, and (ii) restructured our obligations under the outstanding convertible promissory note from Teva, or the Amended Teva Note. The Teva Amendment is intended to allow us to continue to provide ADASUVE product to patients and health care providers either on our own or through another unaffiliated partner, at which time all Teva license rights to ADASUVE would terminate. The Amended Teva Note, provided for (i) the issuance of 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) the contingent repayment of remaining $20,000,000 outstanding balance of the Amended Teva Note in four annual consecutive payments of $5,000,000 beginning on January 31 of 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; (iii) the elimination of the conversion feature and (iv) the prepayment of the outstanding balance of the Amended Teva Note at any time without penalty. Refer to Note 8 - Financing Obligations for further discussion on the Teva Note.

 

As further described under note 13, Subsequent Events, below, on May 9, 2016, we entered into the Merger Agreement pursuant to which  Purchaser  has agreed to commence a cash  tender  offer  to acquire all of the shares of our common stock (excluding  any  shares  of  our  common  stock  held,  directly  or  indirectly,  by  Ferrer)  pursuant  to  the  Offer. Following the consummation of the Offer, the Merger Agreement provides that Purchaser will merge with and into us in the Merger, and we will become a wholly owned subsidiary of Ferrer. There can be no assurance that the Offer or the Merger will be consummated.

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.