Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Basis of Presentation We have prepared the accompanying consolidated financial statements in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP. Our fiscal year ends on December 31. The accompanying consolidated financial statements include our accounts and those of our wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Fair Value of Financial Instruments Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Three levels of inputs, of which the first two are considered observable and the last unobservable, may be used to measure fair value which are the following: · Level 1 — Quoted prices in active markets for identical assets or liabilities. · Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. · Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The following table represents the fair value hierarchy for our financial assets (cash equivalents and marketable securities) by major security type and contingent consideration liability measured at fair value on a recurring basis as of December 31, 2015 and 2014 (in thousands): December 31, 2015 Level 1 Level 2 Level 3 Total Assets Money market funds $ 6,806 $ — $ — $ 6,806 Corporate debt securities — — — — Total assets $ 6,806 $ — $ — $ 6,806 Liabilities Contingent consideration liability $ — $ — $ 2,800 $ 2,800 Total liabilities $ — $ — $ 2,800 $ 2,800 December 31, 2014 Level 1 Level 2 Level 3 Total Assets Money market funds $ 12,674 $ — $ — $ 12,674 Corporate debt securities — 24,617 — 24,617 Total assets $ 12,674 $ 24,617 $ — $ 37,291 Liabilities Contingent consideration liability $ — $ — $ 30,800 $ 30,800 Total liabilities $ — $ — $ 30,800 $ 30,800 Contingent Consideration Liability In connection with the exercise of our option to purchase all of the outstanding equity of Symphony Allegro, Inc., or Allegro, in 2009, we are obligated to make contingent cash payments to the former Allegro stockholders related to certain payments received by us from future collaboration agreements pertaining to ADASUVE/AZ-104 ( Staccato Staccato The projected cash flow assumptions for ADASUVE in the United States are based on internally and externally developed product sales forecasts. The timing and extent of the projected cash flows for ADASUVE for the territories licensed to Ferrer are based on the Ferrer Agreement (Refer to Note 8 – Financing Obligations We then assigned a probability to each of the cash flow scenarios based on several factors, including: the product candidate’s stage of development, preclinical and clinical results, technological risk related to the successful development of the different drug candidates, estimated market size, market risk and potential collaboration interest to determine a risk adjusted weighted average cash flow based on all of these scenarios. These probability and risk adjusted weighted average cash flows were then discounted utilizing our estimated weighted average cost of capital, or WACC. Our WACC considered our cash position, competition, risk of substitute products, and risk associated with the financing of the development projects. In 2013, we reduced the discount rate from 18.0% to 16.5% to reflect our then current estimated WACC. The change in discount rate increased the net loss for 2013 by approximately $3,600,000 or $0.22 per share. In 2014, we increased the discount rate from 16.5% to 20% to reflect our current estimated WACC. The change in discount rate decreased the net loss for 2014 by approximately $6,400,000 or $0.36 per share. The increase in our discount rate reflects the impact of our current financial condition, market capitalization and our estimated increase in borrowing costs. The fair value measurement of the contingent consideration liability is based on significant inputs not observed in the market and thus represents a Level 3 measurement. Level 3 measurements are valued based on unobservable inputs that are supported by little or no market activity and reflect our assumptions in measuring fair value. We record any changes in the fair value of the contingent consideration liability in earnings in the period of the change. Certain events including, but not limited to, the timing and terms of any collaboration agreement, clinical trial results, approval or non-approval of any future regulatory submissions and the commercial success of ADASUVE, AZ-104 or AZ-002 could have a material impact on the fair value of the contingent consideration liability, and as a result, our results of operations and financial position for the impacted period. During the fiscal year ended December 31, 2014, we modified the assumptions associated with the amount and timing of milestones and royalties projected for ADASUVE and AZ-002 and the probability that AZ-002 would be licensed or sold by us. These changes in assumptions, the change in the discount rate and the effects of the passage of a year on the present value computation resulted in a decrease to the net loss of $8,149,000, or $0.46 per share, for the fiscal year ended December 31, 2014. For the fiscal year ended December 31, 2015, we updated the discounted cash flow model to reflect the impact of our reacquisition of the U.S. commercial rights for ADASUVE from Teva by updating the U.S. ADASUVE sales estimates and partnership milestones and changing the probability weightings. Additionally, we updated the sales forecasts for the ADASUVE Ferrer Territories and changed the timing and amount of certain milestones for sales of ADASUVE outside of the United States and the Ferrer Territories and AZ-002. These changes resulted in our recognizing a non-operating, non-cash gain of $27,132,000, or $1.37 per share during the fiscal year ended December 31, 2015. A payment of $0.9 million was made during the first quarter of 2015 to the former Allegro stockholders. The following table represents a reconciliation of the change in the fair value measurement of the contingent consideration liability for the fiscal years ended December 31, 2015 and 2014 (in thousands): December 31, 2015 2014 (In thousands) Beginning balance $ 30,800 $ 39,200 Payments made (868 ) (251 ) Adjustments to fair value measurement (27,132 ) (8,149 ) Ending balance $ 2,800 $ 30,800 Financing Obligations We have estimated the fair value of our financing obligations (Refer to Note 8 – Financing Obligations At December 31, 2015 and 2014, the estimated fair value of our financing obligations was $52,151,000 and $52,075,000, respectively, and had book values of $67,967,000 and $63,767,000, respectively. Our payment commitments associated with these debt instruments may vary with changes in interest rates and are comprised of interest payments and principal payments. The estimated fair value of our debt will fluctuate with movements of interest rates, increasing in periods of declining rates of interest and declining in periods of increasing rates of interest. In addition, the fair value of our royalty securitization financing will be affected by the timing and amount of U.S. ADASUVE royalties and milestones. Concentration of Credit Risk Financial instruments that potentially subject us to credit risk consist of cash and cash equivalents to the extent of the amounts recorded on the balance sheets. Our cash and cash equivalents are placed with high credit-quality U.S. financial institutions and issuers. Cash Equivalents and Marketable Securities We determine the appropriate classification of our investments at the time of purchase. These securities are recorded as either cash equivalents or marketable securities. We consider all highly liquid investments with original maturities of three months or less from date of purchase to be cash equivalents. Cash equivalents consist of interest-bearing instruments including obligations of U.S. government agencies, high credit rating corporate borrowers and money market funds, which are carried at market value. All other investments are classified as available-for-sale marketable securities. We view our available-for-sale investments as available for use in current operations. Accordingly, we have classified all investments as short-term marketable securities, even though the stated maturity date may be one year or more beyond the current balance sheet date. Marketable securities are carried at estimated fair value with unrealized gains or losses included in accumulated other comprehensive income (loss) in stockholders’ (deficit) equity. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest and other income (expense), net. Realized gains and losses, if any, are also included in interest and other income (expense), net. The cost of all securities sold is based on the specific-identification method. Interest and dividends are included in interest income. We review our investments for other than temporary decreases in market value on a quarterly basis. To date, we have not recorded any charges related to other-than-temporary impairments. Restricted Cash In March 2014, from the proceeds from our royalty securitization financing (Refer to Note 7 – Commitments and Contingencies Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated life of the asset, generally three years for computer equipment, five years for manufacturing equipment and laboratory equipment, and seven years for furniture. Leasehold improvements are amortized over the estimated useful life or the remaining lease term, whichever is shorter. Impairment of Long-Lived Assets We review long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. The impairment loss, if recognized, would be based on the excess of the carrying value of the impaired asset over its respective fair value. During the fiscal year ended December 31, 2015, we evaluated the carrying values of our long-lived assets, principally our manufacturing and laboratory equipment and concluded that due to (i) the suspension of the ADASUVE commercial production operations during the third quarter of 2015, (ii) our continued operating losses and poor cash flows, (iii) the uncertainty of when we will resume commercial production, (iv) the limited ability to sell the capitalized equipment, and (v) our basic ability to continue as a going concern, the carrying amounts of our long-lived assets including the first and second manufacturing cells from Autoliv ASP, Inc., or Autoliv, exceeded their fair values based on a Level 3 fair value measurement. We recognized non-cash impairment charges of approximately $8,591,000 on our long-lived assets, $1,229,000 of related inventory with fixed expiration dates, and $1,024,000 on prepayments made to the supplier of our lower housing assembly for fiscal year 2015. We did not recognize any long-lived asset impairment during 2014. Revenue Recognition We recognize revenue when (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) the fee is fixed or determinable; and (iv) collectability is reasonably assured. Prior to the second quarter of 2013, our revenue consisted primarily of amounts earned from collaboration agreements and under research grants with the National Institutes of Health. Beginning in the second quarter of 2013, we also have revenue from product sales and beginning in the first quarter of 2014, we have royalty revenue. For collaboration agreements, revenues for non-refundable upfront license fee payments, where we continue to have performance obligations, are recognized as performance occurs and obligations are completed. Revenues for non-refundable upfront license fee payments where we do not have significant future performance obligations are recognized when the agreement is signed and the payments are due. For multiple element arrangements, such as collaboration agreements in which a collaborator may purchase several deliverables, we account for each deliverable as a separate unit of accounting if both of the following criteria are met: (i) the delivered item or items have value to the customer on a standalone basis; and (ii) for an arrangement that includes a general right of return relative to the delivered item(s), delivery or performance of the undelivered item(s) is considered probable and substantially in our control. We evaluate how the consideration should be allocated among the units of accounting and allocate revenue to each non-contingent element based upon the relative selling price of each element. We determine the relative selling price for each deliverable using (i) vendor-specific objective evidence, or VSOE, of selling price if it exists; (ii) third-party evidence, or TPE, of selling price if it exists; or (iii) our best estimated selling price for that deliverable if neither VSOE nor TPE of selling price exists for that deliverable. We then recognize the revenue allocated to each element when the four basic revenue criteria described above are met for each element. For milestone payments received in connection with our collaboration agreements, we have elected to adopt the milestone method of accounting under Financial Accounting Standards Board Accounting Standards Codification 605-28, Milestone Method. Under the milestone method, revenues for payments which meet the definition of a milestone will be recognized as the respective milestones are achieved. We recognize product revenue as follows: · Persuasive Evidence of an Arrangement · Delivery · Sales Price Fixed or Determinable · Collectability Royalty revenue from our collaboration agreements is recognized as we receive information from our collaborators regarding product sales. Significant management judgment is used in the determination of revenue to be recognized and the period in which it is recognized. Inventory Inventory is stated at standard cost, which approximates actual cost, determined on a first-in first-out basis, not in excess of market value. Inventory includes the direct costs incurred to manufacture products combined with allocated manufacturing overhead, which consists of indirect costs, including labor and facility overhead. The carrying cost of inventory is reduced so as to not be in excess of the market value of the inventory as determined by the contractual transfer prices to Ferrer and Teva. The excess over the market value is expensed to cost of goods sold. If information becomes available that suggests that all or certain of the inventory may not be realizable, we may be required to expense a portion, or all, of the capitalized inventory into cost of goods sold. We have fulfilled all of the orders we received from Teva and Ferrer for commercial units of ADASUVE for the near and medium term. As a result, we have suspended our commercial production operations (Refer to Note 12 - Restructuring Our inventory as of December 31, 2015 and 2014, net of reserves, in thousands, is summarized as follows: December 31, 2015 2014 Raw materials $ — $ 3,677 Work in process — — Finished goods — 52 Total inventory $ — $ 3,729 Research and Development Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services. Research and development costs are expensed as incurred. Clinical development costs are a significant component of research and development expenses. We have a history of contracting with third parties that perform various clinical trial activities on our behalf in the ongoing development of our product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. We accrue and expense costs for clinical trial activities performed by third parties based upon estimates of the percentage of work completed over the life of the individual study in accordance with agreements established with contract research organizations and clinical trial sites. We expect that research and development expenses will decrease during the fiscal year 2016 compared to 2015. We anticipate continuing to incur expenses related to our AZ-002 Phase 2a clinical trial, and, if financing is secured, expenses related to the clinical development of AZ-007. With the suspension of commercial ADASUVE production operations in the third quarter of 2015, a larger percentage of fixed overhead costs were allocated to research and development expenses, beginning in the fourth quarter of 2015. Income Taxes We utilize the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax basis of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Share-Based Compensation Compensation cost for employee share-based awards is based on the grant-date fair value and is recognized on a ratable basis over the requisite service periods of the awards, which are generally the vesting periods. We issue employee share-based awards in the form of stock options and restricted stock units under our equity incentive plans and stock purchase rights under our employee stock purchase plan. Stock Options, Stock Purchase Rights and Restricted Stock Units During the fiscal years ended December 31, 2015, 2014 and 2013, the weighted average fair value per share of the employee stock options, restricted stock units and stock purchase rights granted were: 2015 2014 2013 Stock Options $ 0.80 $ 2.83 $ 3.46 Restricted Stock Units — — 4.67 Stock Purchase Rights 0.67 1.32 1.76 The estimated grant date fair values of the stock options and stock purchase rights were calculated using the Black-Scholes valuation model. The Black-Scholes model requires the use of a number of highly subjective and complex assumptions in determining the fair value of stock-based awards as follows: Weighted-Average Expected Term We determine the expected term of stock options granted through a combination of our own historical exercise experience and expected future exercise activities and post-vesting termination behavior. Under our 2005 Employee Stock Purchase Plan and our 2015 Employee Stock Purchase Plan, the expected term of employee stock purchase plan shares is equal to the offering period. Volatility We utilize our historical volatility to determine future volatility for the purpose of determining share-based payments for all options granted. Risk-Free Interest Rate We utilize U.S. Treasury zero-coupon issues with remaining terms similar to the expected term of the options or purchase rights on the respective grant dates to determine our risk-free interest rate. Dividend Yield We have never declared or paid any cash dividends and do not plan to pay cash dividends in the foreseeable future, and, therefore, use an expected dividend yield of zero in the valuation model. Forfeiture Rate We use historical data to estimate pre-vesting option forfeitures and record stock-based compensation expense only for those awards that are expected to vest. All stock-based payment awards are amortized on a straight-line basis over the requisite service periods of the awards, which are generally the vesting periods. During the fiscal years ended December 31, 2015, 2014 and 2013, we calculated the estimated grant date fair value of stock options and stock purchase rights using the following assumptions: 2015 2014 2013 Stock Option Plans Weighted-average expected term 5.0 Years 5.0 Years 5.0 Years Expected volatility 86% 83% 99% Risk-free interest rate 1.60% 1.66% 0.86% Dividend yield 0% 0% 0% Employee Stock Purchase Plan Weighted-average expected term 0.5 Years 0.5 Years 0.5 Years Expected volatility 87% 61% 80% Risk-free interest rate 0.19% 0.86% 0.70% Dividend yield 0% 0% 0% Restricted Stock Units The estimated fair value of restricted stock unit awards is calculated based on the market price of our common stock on the date of grant, reduced by the present value of dividends expected to be paid on our common stock prior to vesting of the restricted stock unit. Our estimate assumes no dividends will be paid prior to the vesting of the restricted stock unit. In 2013, certain restricted stock unit awards were issued that vest based on market conditions. The estimated fair value of these awards was calculated using a binomial lattice model with a term of 10 years, an expected volatility of 99.4%, a risk-free interest rate of 1.94% and a dividend yield of 0%. As of December 31, 2015, there were $1,725,000, $94,000 and $3,000 total unrecognized compensation costs, net of forfeiture, related to non-vested stock option awards, restricted stock unit awards and stock purchase rights, respectively, which are expected to be recognized over a weighted average period of 3.0 years, 1.1 years and 0.05 years, respectively. Recent Accounting Pronouncements In August 2014, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (“ASU 2014-15”). ASU 2014-15 requires management to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. In doing so, companies will have reduced diversity in the timing and content of footnote disclosures than under the current guidance. ASU 2014-15 is effective for us in the first quarter of 2016 with early adoption permitted. In May 2014, the Financial Accounting Standards Board issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), that will supersede nearly all existing revenue recognition guidance under US GAAP. The core principle of the guidance is that an entity should recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. The standard will be effective for public entities for annual and interim periods beginning after December 15, 2017. Entities can choose to apply the standard using either the full retrospective approach or a modified retrospective approach. Entities electing the full retrospective adoption will apply the standard to each period presented in the financial statements. This means that entities will have to apply the new guidance as if it had been in effect since the inception of all its contracts with customers presented in the financial statements. Entities that elect the modified retrospective approach will apply the guidance retrospectively only to the most current period presented in the financial statements. This means that entities will have to recognize the cumulative effect of initially applying the new standard as an adjustment to the opening balance of retained earnings at the date of initial application. The new revenue standard will be applied to contracts that are in progress at the date of initial application. In July 2015, the Financial Accounting Standards Board issued ASU No. 2015-14, which delays the effective date of the standard for one year to annual periods beginning after December 15, 2017, with early adoption permitted for annual periods beginning after December 15, 2016. We are evaluating the requirements of this guidance and have not yet determined the impact of its adoption on our consolidated financial position, results of operations and cash flows. In April 2015, the Financial Accounting Standards Board issued ASU 2015-03, Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs In February 2016, the Financial Accounting Standards Board issued ASU 2016-02, Leases (Topic 842) which supersedes FASB ASC Topic 840, Leases (Topic 840) - |