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Liquidity Risks and Management's Plans
3 Months Ended
Mar. 31, 2015
Liquidity Risks and Management's Plans [Abstract]  
Liquidity Risks and Management's Plans
Note 2 – Liquidity Risks and Management’s Plans

We have incurred substantial losses since inception, due to investments in research and development, manufacturing, and, more recently, commercialization and medical affairs activities, and we expect to continue to incur substantial losses over the next several years.  Historically, we have funded our business operations through various sources, including public and private securities offerings, debt facilities, strategic alliances, committed equity financing facilities, at-the-market equity programs, and capital equipment financings.  We expect to fund our business operations in the future primarily through all or a combination of strategic alliances, public equity offerings, including under our ATM Program (see, Note 10, “Stockholders’ Equity – At-the-Market Program (ATM Program),” in the Notes to Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2014 that we filed with the Securities and Exchange Commission (SEC) on March 16, 2015 (2014 Form 10-K)), the potential exercise of outstanding warrants, and secured debt facilities.

We recently announced our decision to cease commercialization activities for our only approved product, SURFAXIN® (lucinactant) Intratracheal Suspension for the prevention of RDS in premature infants at high risk for RDS (see, Note 1, “The Company and Description of Business”).  As a result, for the next several years, if ever, we do not expect to generate any revenue from the sale of approved products.  Thus, to secure the significant additional infusions of capital that we will need to execute our business strategy, advance our development programs, pay debt obligations and fund our operations, we will have to rely on non-sales sources of capital, including potentially: (i) strategic alliances and collaboration arrangements, which could provide development and commercial expertise as well as financial resources to support the development and, if approved, commercial introduction of, our KL4 surfactant pipeline product candidates, beginning with AEROSURF, in markets outside the U.S., (ii) public and private equity offerings, including potentially pursuant to our ATM Program, (iii) secured debt arrangements to provide working capital and fund investment in capital assets, and (iv) the potential exercise of outstanding warrants (discussed below).  In addition, we have in the past collaborated with research organizations and universities to assess potential application of our KL4 surfactant in studies funded in part through various U.S. Government-sponsored drug development programs, including grants in support of initiatives related to our AEROSURF clinical program and biodefense-related initiatives under programs that encourage private sector development of medical countermeasures against chemical, biological, radiological, and nuclear terrorism threat agents, and pandemic influenza, and provide a mechanism for federal acquisition of such countermeasures.  We expect that we may have opportunities in the future to participate in similar programs.

As of March 31, 2015, we had cash and cash equivalents of $35.6 million and long-term debt of $30 million under our loan with affiliates of Deerfield Management Company, L.P. (Deerfield) (see, Note 9, “Deerfield Loan,” in the Notes to Consolidated Financial Statements in our 2014 Form 10-K).  Under our ATM Program, subject to market conditions, we may sell up to approximately $23 million of common stock at such times and in such amounts that we deem appropriate, subject to a 3% commission.  We also will consider public and private equity offerings or other financing transactions, including potentially secured equipment financing facilities or other similar transactions.  Under our collaboration agreement with Battelle Memorial Institute (Battelle), we have agreed to share equally in the planned cost of a project to develop our CAG device for use in our planned AEROSURF phase 3 clinical program and, if approved, initial commercialization.  If we are able to successfully complete our collaboration with Battelle as currently planned, we anticipate that our investment through the end of 2016 will be approximately $6 million to $8 million for all device development activities to be in a position to manufacture CAG devices, ADPs and related components for use in the planned AEROSURF phase 3 clinical program and, if approved, initial commercialization.  In addition, at our discretion from time to time, we may defer payment of amounts due to Battelle under our collaboration agreement in respect of our share of development costs for up to 12 months.  Any such deferred amounts that are outstanding for more than 90 days will bear interest at a rate of 12% per annum.  In addition, we have agreed that the aggregate amounts deferred beyond 30 days will not exceed our available cash and cash equivalents.  We currently have deferred certain payments and expect to defer payments of up to approximately $3.0 million through the first quarter of 2016.  Before any additional financings and taking into account our recent decision to cease our SURFAXIN commercial activities and allow our real property lease at our manufacturing facility in Totowa, NJ (Totowa Facility) to expire on June 30, 2015 in accordance with its terms, we anticipate that we will have sufficient cash available to support our AEROSURF clinical program, pay our debt service obligations and fund our operations through the first quarter of 2016.

To secure the capital required to fund our development programs, an important priority for us is to identify strategic transactions that could provide additional capital and strategic resources to support the continued development and, if approved, commercial introduction of AEROSURF for RDS and our other potential KL4 surfactant products in markets outside the U.S.  For AEROSURF, we seek a significant strategic alliance with a partner that has broad experience in markets outside the U.S., including regulatory and product-development expertise and, if AEROSURF is approved, an ability to support the commercial introduction of AEROSURF in selected markets outside the U.S.  Such alliances typically also would provide financial resources, in the form of upfront payments, milestone payments, commercialization royalties and a sharing of research and development expenses.  We believe that we will be better positioned to identify and enter into a significant strategic alliance for AEROSURF if we obtain encouraging results from the AEROSURF phase 2 clinical program.
 
As of March 31, 2015, we had outstanding warrants to purchase approximately 14.6 million shares of our common stock at various prices, exercisable on different dates into 2024.  This includes warrants to purchase 7 million shares that were issued to Deerfield in connection with the Deerfield Loan at an exercise price of $2.81 per share (Deerfield Warrants).  The Deerfield Warrants may be exercised for cash or on a cashless basis.  In lieu of paying cash upon exercise, the holders also may elect to reduce the principal amount of the Deerfield Loan in an amount sufficient to satisfy the exercise price of the Deerfield Warrants.  In addition to the Deerfield Warrants, we have outstanding warrants issued in February 2011 to purchase approximately 4.6 million shares of common stock that expire in February 2016 and contain anti-dilution provisions that adjust the exercise price if we issue any common stock, securities convertible into common stock, or other securities (subject to certain exceptions) at a value below the then-existing exercise price of the warrants.  These warrants currently have an exercise price of $1.50 per share.  If the market price of our common stock should exceed $1.50 at any time prior to the expiration date of these warrants (February 2016) and if the holders determine in their discretion to exercise these warrants (and we have an effective registration statement covering the warrant shares to be issued upon exercise of the warrants), we potentially could receive up to approximately $6.8 million.  There can be no assurance that the price of our common stock will achieve the needed level, that holders of the Deerfield Warrants would choose to exercise their warrants for cash, or that holders of any of our outstanding warrants would choose to exercise any or all of their warrants prior to the applicable warrant expiration dates.  Moreover, if our outstanding warrants are exercised, such exercises likely will be at a discount to the then-market value of our common stock and have a dilutive effect on the value of our shares of common stock at the time of exercise.

Our ability to execute our business plan will depend upon our ability to secure the necessary capital.  If we are unable to secure sufficient additional capital, through strategic and collaborative arrangements with potential partners and/or future debt and equity financings, we will not have sufficient cash flows and liquidity to fund our business operations and pay our debt service.  In that event, we may be forced to further limit our development programs and consider other means of creating value for our stockholders, such as licensing the development and/or commercialization of products that we consider valuable and might otherwise plan to develop ourselves.  If we are unable to raise the necessary capital, we may be forced to curtail all of our activities and, ultimately, cease operations.  Even if we are able to raise additional capital, such financings may only be available on unattractive terms, or could result in significant dilution of stockholders’ interests and, in such event, the market price of our common stock may decline.  If the market price of our common stock should decline below $1.00 and remain at that level for 30 consecutive business days, we would be out of compliance with Nasdaq requirements for listing on the Nasdaq Capital Market and would be subject to potential delisting.  If we were then unable to re-achieve compliance with the Nasdaq listing requirements within 180 days after receipt of a delisting notice, we would be subject to delisting, which likely would further impair the liquidity and value of our common stock.  Moreover, if we fail in the future to make any required payment under our Deerfield Loan or fail to comply with any commitments contained in the loan documents, Deerfield would be able to declare us in default regarding that indebtedness, which could result in the acceleration of the payment obligations under all or a portion of our indebtedness.  Since we have pledged substantially all of our assets to secure our obligations under the Deerfield Loan, a debt default would enable the lenders to foreclose on our assets securing the debt and could significantly diminish the market value and marketability of our common stock.  Our financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue in existence.

Our future capital requirements will depend upon many factors, including our efforts to (i) advance the AEROSURF development program to completion of the phase 2 clinical trials in RDS as planned; (ii) assure long-term continuity of supply for our lyophilized KL4 surfactant drug product with our contract manufacturing organization (CMO), (iii) through our collaboration arrangement with Battelle, advance the development of our CAG for use in a planned phase 3 clinical program and, if approved, early commercial activities, (iv) prepare for and conduct an AEROSURF phase 3 clinical program, and (v) secure one or more strategic alliances or other collaboration arrangements to support our development programs and commercialization of our approved products, if any, in markets outside the U.S.  We believe that we will be better positioned to enter into a significant strategic alliance for AEROSURF if we obtain encouraging results from the AEROSURF phase 2 clinical program.

There can be no assurance (i) that our AEROSURF development program will be successful within our anticipated time frame, if at all, (ii) that we will be able to secure long-term continuity of drug product supply of our lyophilized KL4 surfactant, (iii) that we will be able to secure regulatory marketing authorization for AEROSURF and our other potential KL4 surfactant product candidates in the U.S. and other markets, (iv) that any of our approved products will be commercially viable, (v) that the ATM Program will be available when needed, if at all, or (vi) that we otherwise will be able to obtain additional capital when needed and on acceptable terms. We will require significant additional capital to execute our business strategy, pay debt service and sustain operations.  Failure to secure the necessary additional capital when needed would have a material adverse effect on our business, financial condition and results of operations.  Even if we succeed in our efforts and subsequently commercialize our products, we may never achieve sufficient sales revenue to achieve or maintain profitability.

As of March 31, 2015, there were 250 million shares of common stock authorized under our Amended and Restated Certificate of Incorporation, as amended, and approximately 135.9 million shares of common stock were available for issuance and not otherwise reserved.