Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | 1-May-15 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | FALSE | |
Document Period End Date | 31-Mar-15 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | ALXA | |
Entity Registrant Name | Alexza Pharmaceuticals Inc. | |
Entity Central Index Key | 1344413 | |
Current Fiscal Year End Date | -19 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 19,422,854 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Mar. 31, 2015 | Dec. 31, 2014 | |
In Thousands, unless otherwise specified | |||
Current assets: | |||
Cash and cash equivalents | $11,093 | $15,200 | [1] |
Marketable securities | 11,427 | 19,574 | [1] |
Receivables | 99 | 173 | [1] |
Inventory | 2,472 | 3,729 | [1] |
Prepaid expenses and other current assets | 2,169 | 3,109 | [1] |
Total current assets | 27,260 | 41,785 | [1] |
Property and equipment, net | 11,693 | 13,953 | [1] |
Restricted cash | 1,361 | 2,757 | [1] |
Other assets | 2,856 | 3,065 | [1] |
Total assets | 43,170 | 61,560 | [1] |
Current liabilities: | |||
Accounts payable | 1,565 | 1,799 | [1] |
Accrued clinical trial expenses | 313 | 875 | [1] |
Other accrued expenses | 3,113 | 4,693 | [1] |
Current portion of contingent consideration liability | 800 | 1,700 | [1] |
Current portion of deferred revenue | 2,450 | 2,450 | [1] |
Total current liabilities | 8,241 | 11,517 | [1] |
Deferred rent | 4,452 | 4,781 | [1] |
Noncurrent portion of contingent consideration liability | 14,300 | 29,100 | [1] |
Noncurrent portion of deferred revenues | 2,450 | 3,063 | [1] |
Noncurrent portion of financing obligations | 64,157 | 63,767 | [1] |
Other noncurrent liabilities | 1,237 | 985 | [1] |
Stockholders' deficit: | |||
Preferred stock | 0 | 0 | [1] |
Common stock | 2 | 2 | [1] |
Additional paid-in-capital | 359,696 | 359,308 | [1] |
Accumulated other comprehensive loss | -1 | -3 | [1] |
Accumulated deficit | -411,364 | -410,960 | [1] |
Total stockholders' deficit | -51,667 | -51,653 | [1] |
Total liabilities and stockholders' deficit | $43,170 | $61,560 | [1] |
[1] | (1) The condensed consolidated balance sheet at December 31, 2014 has been derived from audited consolidated financial statements at that date. |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Loss and Comprehensive Loss (USD $) | 3 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Revenue | ||
Collaboration revenue | $618 | $1,728 |
Product sales | 87 | 438 |
Total revenue | 705 | 2,166 |
Operating expenses: | ||
Cost of goods sold | 6,147 | 3,791 |
Research and development | 3,824 | 3,130 |
General and administrative | 3,737 | 4,048 |
Total operating expenses | 13,708 | 10,969 |
Loss from operations | -13,003 | -8,803 |
(Loss)/gain on change in fair value of contingent consideration liability | 14,833 | -1,150 |
Interest and other income/ (expense), net | -5 | 6 |
Interest expense | -2,229 | -788 |
Net loss | -404 | -10,735 |
Basic and diluted net loss per share | ($0.02) | ($0.62) |
Shares used to compute basic and diluted net loss per share | 19,750 | 17,282 |
Other Comprehensive Loss | ||
Change in unrealized gain/ (loss) on marketable securities | 2 | -1 |
Comprehensive loss | ($402) | ($10,736) |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Cash Flows (USD $) | 3 Months Ended | ||
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 | |
Cash flows from operating activities: | |||
Net loss | ($404) | ($10,735) | |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Share-based compensation | 388 | 818 | |
Change in fair value of contingent consideration liability | -14,833 | 1,150 | |
Amortization of debt discount, deferred interest and right-to-borrow asset | 642 | 409 | |
Amortization of premium (discount) on available-for-sale securities | 50 | 2 | |
Impairment of property and equipment | 1,381 | 0 | |
Depreciation and amortization | 879 | 831 | |
Changes in operating assets and liabilities: | |||
Receivables | 74 | -149 | |
Inventory | 1,257 | -990 | |
Prepaid expenses and other current assets | 731 | -77 | |
Other assets | 165 | 0 | |
Accounts payable | -234 | -384 | |
Accrued clinical and other accrued liabilities | -2,140 | -1,346 | |
Deferred revenues | -613 | -428 | |
Other liabilities | -77 | -251 | |
Net cash used in operating activities | -12,734 | -11,150 | |
Cash flows from investing activities: | |||
Purchase of available-for-sale securities | -5,442 | 0 | |
Maturities of available-for-sale securities | 13,540 | 8,575 | |
Purchases of property and equipment | -174 | ||
Net cash provided by investing activities | 8,098 | 8,401 | |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock and warrants and exercise of stock options and stock purchase rights | 0 | 11 | |
Change in restricted cash | 1,396 | -6,890 | |
Payment on contingent consideration liability | -867 | -250 | |
Proceeds from financing obligations, net of issuance costs | 0 | 45,829 | |
Payments of financing obligations | 0 | -189 | |
Net cash provided by financing activities | 529 | 38,511 | |
Net (decrease)/increase in cash and cash equivalents | -4,107 | 35,762 | |
Cash and cash equivalents at beginning of period | 15,200 | [1] | 17,306 |
Cash and cash equivalents at end of period | 11,093 | 53,068 | |
Non-cash investing and financing activities: | |||
Value of warrants issued with royalty securitization financing | 0 | 1,721 | |
Value of the beneficial conversion feature related to borrowings against the Teva Note | $0 | $883 | |
[1] | (1) The condensed consolidated balance sheet at December 31, 2014 has been derived from audited consolidated financial statements at that date. |
The_Company_and_Basis_of_Prese
The Company and Basis of Presentation | 3 Months Ended |
Mar. 31, 2015 | |
Accounting Policies [Abstract] | |
The Company and Basis of Presentation | 1. The Company and Basis of Presentation |
Business | |
We were incorporated in the state of Delaware on December 19, 2000 as FaxMed, Inc., changed our name to Alexza Corporation in June 2001 and in December 2001 became Alexza Molecular Delivery Corporation. In July 2005, we changed our name to Alexza Pharmaceuticals, Inc. | |
We are a pharmaceutical company focused on the research, development, and commercialization of novel proprietary products for the acute treatment of central nervous system conditions. We operate in one business segment. Our facilities and employees are currently located in the United States. | |
Basis of Presentation | |
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not contain all of the information and footnotes required for complete financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly our interim condensed consolidated financial information. The results for the three months ended March 31, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015 or for any other interim period or any other future year. | |
The accompanying unaudited condensed consolidated financial statements and notes to condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2014 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 13, 2015. | |
Basis of Consolidation | |
The unaudited condensed consolidated financial statements include our accounts and those of our wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated. |
Need_to_Raise_Additional_Capit
Need to Raise Additional Capital | 3 Months Ended |
Mar. 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 March 31, 2015, we had cash, cash equivalents, marketable securities and restricted cash (see Note 4) of $23.9 million and working capital of $19.0 million. Our operating and capital plans call for cash expenditures to exceed these amounts over the next twelve months. We plan to raise additional capital to fund our operations and to develop our product candidates. We plan to finance our operations through partnership or licensing collaborations, the sale of equity securities or debt arrangements. Such funding 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 and our expected cash usage, we estimate that we have sufficient capital resources to meet our anticipated cash needs into the fourth quarter of 2015. Also, as discussed in Note 12, the Company plans to suspend manufacturing during the third quarter of 2015 in an effort to reduce its cash outflows. | |
The accompanying financial statements have been prepared assuming we will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts of liabilities that may result from uncertainty related to our ability to continue as a going concern. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Accounting Policies [Abstract] | |||||||||
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies | ||||||||
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. | |||||||||
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. We currently sell product through license and supply agreements with our collaborators, Grupo Ferrer Internacional, S.A., or Ferrer, and Teva Pharmaceuticals USA, Inc., or Teva. Persuasive evidence of an arrangement is generally determined by the receipt of an approved purchase order from the collaborator in connection with the terms of the related license and supply agreements. | ||||||||
• | Delivery. Typically, ownership of the product passes to the collaborator upon shipment. Our current license and supply agreements also provide our collaborators with an acceptance period during which they may reject any product which does not conform to agreed-upon specifications. Because ADASUVE is a new product, a new technology and our first product to be commercialized, and because we do not have a history of producing product to collaborator specifications, we will not consider delivery to have occurred until after the collaborator acceptance period has ended or the collaborator has positively accepted the product. Once we have demonstrated over the course of time an ability to reliably produce the product to collaborator specifications, we will consider delivery to have occurred upon shipment in the absence of any other relevant shipment or acceptance terms. | ||||||||
• | Sales Price Fixed or Determinable. Sales prices for product shipments are determined by the license and supply agreements and documented in the purchase orders. After the collaborator acceptance period has ended or the collaborator has positively accepted the product, our collaborators do not have any product return or replacement rights, including for expired products. | ||||||||
• | Collectability. Payment for the product is contractually obligated under the license and supply agreements. We will monitor payment histories for our collaborators and specific issues as they arise to determine whether collection is probable for a specific transaction and defer revenue as necessary. | ||||||||
Royalty revenue from our collaboration agreements will be recognized as we receive information from our collaborators regarding product sales and collectability is reasonably assured. | |||||||||
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. We are in the early stages of commercialization and have incurred significantly higher than normal indirect costs in the production of our inventory due to start-up manufacturing costs and low production volumes. 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. Inventory, which is stated at the lower of cost or estimated market value, consists of the following at March 31, 2015 and December 31, 2014 (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Raw materials | $ | 1,788 | $ | 3,677 | |||||
Work in process | 8 | — | |||||||
Finished goods | 676 | 52 | |||||||
Total inventory | $ | 2,472 | $ | 3,729 | |||||
As discussed in Note 12 below, during the three-months ended March 31, 2015, we recorded a reserve of $1,229,000 related to certain raw materials that, based on current ADASUVE sales, production, and related projections, will not be used prior to expiration. | |||||||||
Contingencies | |||||||||
From time to time, we are involved in lawsuits, arbitrations, claims, investigations and proceedings that arise in the ordinary course of business. We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. No such provisions have been made for the periods presented herein. Litigation and related matters are inherently unpredictable. If any unfavorable ruling were to occur in any specific period, there exists the possibility of a material adverse impact on the results of operations of that period or on our cash flows and liquidity. | |||||||||
New 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. We do not believe the impact of adopting ASU 2014-15 on our results of operations or financial position. | |||||||||
In May 2014 the Financial Accounting Standards Board, or FASB, issued the Accounting Standards Update, or 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 the company expects 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, 2016. | |||||||||
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 April 2015, the Financial Accounting Standards Board tentatively decided to defer 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. |
Fair_Value_Accounting
Fair Value Accounting | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||
Fair Value Accounting | 4. Fair Value Accounting | ||||||||||||||||
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability 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. The three levels are: | |||||||||||||||||
• | 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, marketable securities and restricted cash) by major security type and contingent consideration liability measured at fair value on a recurring basis as of March 31, 2015 and December 31, 2014 (in thousands): | |||||||||||||||||
March 31, 2015 | Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets | |||||||||||||||||
Money market funds | $ | 10,525 | $ | — | $ | — | $ | 10,525 | |||||||||
Corporate debt securities | — | 13,173 | — | 13,173 | |||||||||||||
Total assets | $ | 10,525 | $ | 13,173 | $ | — | $ | 23,698 | |||||||||
Liabilities | |||||||||||||||||
Contingent consideration liability | $ | — | $ | — | $ | 15,100 | $ | 15,100 | |||||||||
Total liabilities | $ | — | $ | — | $ | 15,100 | $ | 15,100 | |||||||||
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 | |||||||||
Cash equivalents and marketable securities | |||||||||||||||||
The amortized cost, fair value and unrealized gain/(loss) for our financial assets by major security type as of March 31, 2015 and December 31, 2014 are as follows (in thousands): | |||||||||||||||||
March 31, 2015 | Amortized | Fair Value | Unrealized | ||||||||||||||
Cost | Gain/(Loss) | ||||||||||||||||
Money market funds | $ | 10,525 | $ | 10,525 | $ | — | |||||||||||
Corporate debt securities | 13,174 | 13,173 | (1 | ) | |||||||||||||
Total | 23,699 | 23,698 | (1 | ) | |||||||||||||
Less amounts classified as restricted cash | (1,361 | ) | (1,361 | ) | — | ||||||||||||
Less amounts classified as cash equivalents | (10,910 | ) | (10,910 | ) | — | ||||||||||||
Total marketable securities | $ | 11,428 | $ | 11,427 | $ | (1 | ) | ||||||||||
December 31, 2014 | Amortized Cost | Fair Value | Unrealized | ||||||||||||||
Gain/(Loss) | |||||||||||||||||
Money market funds | $ | 12,674 | $ | 12,674 | $ | — | |||||||||||
Corporate debt securities | 24,620 | 24,617 | (3 | ) | |||||||||||||
Total | 37,294 | 37,291 | (3 | ) | |||||||||||||
Less amounts classified as restricted cash | (2,757 | ) | (2,757 | ) | — | ||||||||||||
Less amounts classified as cash equivalents | (14,960 | ) | (14,960 | ) | — | ||||||||||||
Total marketable securities | $ | 19,577 | $ | 19,574 | $ | (3 | ) | ||||||||||
We had no sales of marketable securities during the three months ended March 31, 2015 or 2014. | |||||||||||||||||
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 loxapine) or AZ-002 (Staccato alprazolam). In order to estimate the fair value of the liability associated with the contingent cash payments, we prepared several cash flow scenarios for ADASUVE, AZ-104 and AZ-002, which are subject to the contingent payment obligation. Each potential cash flow scenario consisted of assumptions of the range of estimated milestone and license payments potentially receivable from such collaborations and assumed royalties received from future product sales. Based on these estimates, we computed the estimated payments to be made to the former Allegro stockholders. Payments were assumed to terminate in accordance with current agreement terms or, if no agreements exist, upon the expiration of the related patents. | |||||||||||||||||
The projected cash flow assumptions for ADASUVE in the United States are based on the License and Supply Agreement, or the Teva Agreement, between us and Teva (see Note 10) and on internally and externally developed product sales forecasts. The timing and extent of the projected cash flows for ADASUVE for Europe, Latin America and the Commonwealth of Independent States countries, or the Ferrer Territories, are based on the Collaboration, License and Supply Agreement, or Ferrer Agreement, between us and Ferrer (see Note 10). The timing and extent of the projected cash flows for the remaining territories for ADASUVE and worldwide territories for AZ-002 and AZ-104 were based on internal estimates for potential milestones and multiple product royalty scenarios and are also consistent in structure to the most recently negotiated collaboration agreements. | |||||||||||||||||
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. For the three months ended March 31, 2014, these probability and risk adjusted weighted average cash flows were then discounted utilizing our estimated weighted average cost of capital, or WACC, of 16.5%. In the fourth quarter of 2014, we adjusted our WACC to 20%. Our WACC considered our cash position, competition, risk of substitute products, and risk associated with the financing of the development projects. | |||||||||||||||||
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 projected 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 three months ended March 31, 2015, we updated the discounted cash flow model to reflect adjusted ADASUVE sales projections and the projected timing of the receipt of certain milestone payments. As part of this process, we received updated projections from our collaboration partners in late March, 2015 that indicated sales of ADASUVE would be lower in 2015 and 2016 than had been anticipated in the various projections and scenarios used to estimate the contingent consideration liability in previous periods. As a result of these lower projected sales and the decision to suspend our commercial production operations (see Note 12), we reevaluated the rate at which we believe sales will increase, the amount of peak sales, the period of time it will take to reach peak sales, the number of years at which peak sales would be achieved, and the related impact on the amount and timing of related royalties and milestones to be received. This evaluation resulted in a decrease to projected sales and the related milestones and royalties under the high, medium, and low sales scenarios and a heavier weighting to the lower sales scenario. These changes on the discounted cash flow model resulted in a decrease to our net loss of $14,833,000, or $0.75 per share, for the three months ended March 31, 2015. | |||||||||||||||||
During the three months ended March 31, 2014, we updated the discounted cash flow model to reflect the passage of three months and adjusted the timing of the receipt of certain milestone payments. These changes on the discounted cash flow model resulted in an increase to our net loss of $1,150,000 or $0.07 per share, for the three months ended March 31, 2014. | |||||||||||||||||
The following table represents a reconciliation of the change in the fair value measurement of the contingent consideration liability for the three months ended March 31, 2015 and 2014 (in thousands): | |||||||||||||||||
Three Months Ended | |||||||||||||||||
March 31, | |||||||||||||||||
2015 | 2014 | ||||||||||||||||
Beginning balance | $ | 30,800 | $ | 39,200 | |||||||||||||
Payments made | (867 | ) | (250 | ) | |||||||||||||
Adjustments to fair value measurement | (14,833 | ) | 1,150 | ||||||||||||||
Ending balance | $ | 15,100 | $ | 40,100 | |||||||||||||
Financing Obligations | |||||||||||||||||
We estimated the fair value of our financing obligations (see Note 8) using the net present value of the payments discounted at an interest rate that is consistent with our estimated current borrowing rate for similar long-term debt. We believe the estimates used to measure the fair value of the financing obligations constitute Level 3 inputs. | |||||||||||||||||
At March 31, 2015 and December 31, 2014, the estimated fair value of our financing obligations was $51,581,000 and $52,075,000, respectively and had book values of $64,157,000 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 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. |
ShareBased_Compensation_Plans
Share-Based Compensation Plans | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||
Share-Based Compensation Plans | 5. Share-Based Compensation Plans | ||||||||
The following table sets forth the summary of option activity under our share-based compensation plans (the 2005 Equity Incentive Plan, or 2005 Plan and the 2005 Non-Employee Director Stock Award Plan, or the Directors’ Plan) for the three months ended March 31, 2015: | |||||||||
Outstanding Options | |||||||||
Number of | Weighted | ||||||||
Shares | Average | ||||||||
Exercise Price | |||||||||
Outstanding at January 1, 2015 | 1,978,273 | $ | 7.1 | ||||||
Options granted | 52,500 | 1.94 | |||||||
Options exercised | — | — | |||||||
Options canceled | (182,521 | ) | 5.19 | ||||||
Outstanding at March 31, 2015 | 1,848,252 | 7.14 | |||||||
There were no options exercised during the three months ended March 31, 2015. The intrinsic value of options exercised during the three months ended March 31, 2014 was $5,000. | |||||||||
The following table sets forth the summary of restricted stock units, or RSUs, activity under our share-based compensation plans for the three months ended March 31, 2015: | |||||||||
Number | Weighted | ||||||||
Of | Average | ||||||||
Shares | Grant-Date | ||||||||
Fair Value | |||||||||
Outstanding at January 1, 2014 | 81,050 | $ | 4.67 | ||||||
Granted | — | — | |||||||
Released | — | — | |||||||
Forfeited | (2,925 | ) | 4.67 | ||||||
Outstanding at March 31, 2015 | 78,125 | $ | 4.67 | ||||||
At March 31, 2015, RSUs to purchase 21,875 shares of common stock were vested but unreleased. These RSUs will be released upon opening of the quarterly trading window in May 2015. | |||||||||
On January 1, 2015 and 2014 an additional 100,000 shares were authorized for issuance under the evergreen provisions of the 2005 Plan. On January 1, 2015 and 2014, an additional 75,000 shares and 58,751 shares, respectively, were authorized for issuance under the evergreen provisions of the Directors’ Plan. | |||||||||
As of March 31, 2015, 1,886,906 and 225,000 shares remained available for issuance under the 2005 Plan and the Directors’ Plan, respectively. | |||||||||
2005 Employee Stock Purchase Plan | |||||||||
Pursuant to the 2005 Employee Stock Purchase Plan, or ESPP, an additional 75,000 shares were reserved for issuance on January 1, 2015 and 2014, respectively. We did not issue any shares under the ESPP during the three months ended March 31, 2015 or 2014. At March 31, 2015, 154,406 shares were available for issuance under the ESPP. |
ShareBased_Compensation
Share-Based Compensation | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||
Share-Based Compensation | 6. Share-Based Compensation | ||||||||
Employee Share-Based Awards | |||||||||
Compensation cost for employee share-based awards is based on the grant-date fair value and is recognized over the vesting period of the applicable award on a straight-line basis. 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 the ESPP (see Note 5). | |||||||||
Valuation of Stock Options, Stock Purchase Rights and Restricted Stock Units | |||||||||
During the three months ended March 31, 2015 and 2014, the per share weighted average fair value of employee stock options granted were as follows: | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Stock options | $ | 1.29 | $ | 3.69 | |||||
Restricted stock units | — | — | |||||||
Stock purchase rights | 0.67 | 2.03 | |||||||
The estimated grant date fair values of the stock options and stock purchase rights were calculated using the Black-Scholes valuation model, and the following weighted average assumptions: | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Stock Option Plans | |||||||||
Expected term | 5.0 years | 5.0 years | |||||||
Expected volatility | 85 | % | 87 | % | |||||
Risk-free interest rate | 1.4 | % | 1.54 | % | |||||
Dividend yield | 0 | % | 0 | % | |||||
Employee Stock Purchase Plan | |||||||||
Expected term | 0.5 years | 0.5 years | |||||||
Expected volatility | 60 | % | 92 | % | |||||
Risk-free interest rate | 1.62 | % | 1.37 | % | |||||
Dividend yield | 0 | % | 0 | % | |||||
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. | |||||||||
As of March 31, 2015, there was $2,564,000, $290,000, and $3,000 of total unrecognized compensation expense related to unvested stock option awards, unvested restricted stock units and stock purchase rights, respectively, which are expected to be recognized over a weighted average period of 2.5 years, 1.9 years, and 0.1 years, respectively. | |||||||||
Share-based compensation capitalized at March 31, 2015 was not material. |
Net_Loss_per_Share
Net Loss per Share | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Earnings Per Share [Abstract] | |||||||||
Net Loss per Share | 7. Net Loss per Share | ||||||||
Basic and diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. The following items were excluded in the net loss per share calculation for the three months ended March 31, 2015 and 2014 because the inclusion of such items would have had an anti-dilutive effect: | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Stock options | 1,913,263 | 2,216,410 | |||||||
Restricted stock units | 79,588 | 499,175 | |||||||
Warrants to purchase common stock | 5,918,943 | 6,634,897 | |||||||
Convertible debt | 5,382,363 | 3,933,151 |
Financing_Obligations
Financing Obligations | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||
Financing Obligations | 8. Financing Obligations | ||||||||||||||||
Teva Pharmaceuticals USA, Inc. | |||||||||||||||||
In May 2013, concurrent with the Teva Agreement (see Note 10), we entered into a Convertible Promissory Note and Agreement to Lend, dated as of May 7, 2013, between us and Teva, or the Teva Note. Under the terms of the Teva Note, we had the ability, upon written notice to Teva, draw upon the Teva Note to fund agreed operating budgets related to ADASUVE. The aggregate drawdowns totaled up to $25,000,000 and are due and payable, together with all interest, on the fifth anniversary of the signing of the Teva Note. We may prepay, from time to time, up to one-half of the total amounts advanced plus the related interest outstanding at any time prior to the maturity date. At any time prior to five days before the maturity date, Teva will have the right to convert the then outstanding amounts into shares of our common stock at a conversion price of $4.4833 per share. The Teva Note bears simple interest of 4% per year. | |||||||||||||||||
We had fully drawn the $25,000,000 available under the Teva Note as of December 31, 2014. At the time of the drawdowns, the contractual conversion price was less than the value of our common stock. As a result, at each draw down date, we calculated the value of the beneficial conversion feature of the convertible note and recorded an increase to additional paid-in-capital and a discount on the Teva Note which is being amortized to interest expense over the life of the borrowing. Additionally, at each draw, we reclassified the relative portion of the unamortized right-to-borrow asset, classified as an Other Asset, against the Teva Note, which will is also being amortized to interest expense over the life of the borrowing. | |||||||||||||||||
As we drew on the Teva Note, the relative portion of the unamortized right-to-borrow was accounted for as a discount on the borrowing and is being amortized to interest expense over the life of the borrowing. The following table shows the effective interest rate for each drawdown after taking into consideration the beneficial ownership features and the right-to-borrow asset discount. | |||||||||||||||||
Draw | Beneficial | Reclassified | Effective | ||||||||||||||
Amount | Conversion | Unamortized | Interest | ||||||||||||||
Feature | Right-to- | Rate | |||||||||||||||
Borrow | |||||||||||||||||
Sep-13 | $ | 10,000,000 | $ | 2,455,000 | $ | 900,000 | 14.2 | % | |||||||||
Dec-13 | 5,000,000 | 657,000 | 393,000 | 10.2 | % | ||||||||||||
Mar-14 | 5,000,000 | 883,000 | 318,000 | 11.6 | % | ||||||||||||
Jun-14 | 5,000,000 | 148,000 | 252,000 | 6.6 | % | ||||||||||||
We recognized $216,000 of interest expense related to amortization of the right-to-borrow asset during the three months ended March 31, 2014. As of December 31, 2014, all of the right-to-borrow asset had been reclassified against the Teva note. | |||||||||||||||||
Royalty Securitization Financing | |||||||||||||||||
In March 2014, we completed a royalty securitization financing, which consisted of a private placement to qualified institutional investors of $45,000,000 of non-recourse notes issued by our wholly-owned subsidiary, or the Notes, and warrants to purchase 345,661 shares of our common stock at a price of $0.01 per share exercisable for five years from the date of issuance. The Notes bear interest at 12.25% per annum payable quarterly beginning June 15, 2014. All royalty and milestone payments under the Teva Agreement, after paying interest, administrative fees, and any applicable taxes, will be applied to principal and interest payments on the Notes until the Notes have been paid in full. | |||||||||||||||||
The Notes are secured by the right to receive royalty and milestone payments under the Teva Agreement and our equity ownership in the wholly-owned subsidiary. The Notes have no other recourse to us. The Notes may not be redeemed at our option until after March 18, 2016, and may be redeemed after that date subject to the achievement of certain milestones and the payment of a redemption premium for any redemption occurring prior to March 19, 2019. The Notes are not convertible into Alexza equity, nor have we guaranteed them. From the proceeds of the transaction, we established a $6,890,000 interest reserve account, which is classified as a noncurrent asset, to cover any potential shortfall in interest payments. At March 31, 2015, $1,361,000 remains in the interest reserve account. | |||||||||||||||||
We valued the warrants issued to the debt holders utilizing the Black-Scholes valuation model with an assumed volatility of 87%, an estimated life of 5 years, a 1.54% risk-free interest rate and a dividend rate of 0%. The total value of the warrants, $1,721,000, was recognized as an increase to Additional Paid In Capital and as a discount to the Notes. The amount will be amortized into interest expense over a five-year period. We incurred total fees and expenses of $4,171,000, which we recorded as a noncurrent Other Asset, and are amortizing into interest expense over a five-year period. | |||||||||||||||||
Future Scheduled Payments | |||||||||||||||||
Future scheduled principal payments under our various debt obligations as of March 31, 2015 are as follows (in thousands): | |||||||||||||||||
Total | |||||||||||||||||
2015 - remaining 9 months | — | ||||||||||||||||
2016 | — | ||||||||||||||||
2017 | — | ||||||||||||||||
2018 | 25,000 | ||||||||||||||||
Thereafter | — | ||||||||||||||||
Total | $ | 25,000 | |||||||||||||||
The above table excludes any payments pursuant to the $45,000,000 from the royalty securitization financing notes of our wholly-owned subsidiary, which have a legal maturity date in 2027. The principal payments by the subsidiary under the royalty securitization financing will be dependent upon the timing and amounts of royalties and milestone payments received under the Teva Agreement. |
Facility_Leases
Facility Leases | 3 Months Ended |
Mar. 31, 2015 | |
Leases [Abstract] | |
Facility Leases | 9. Facility Leases |
We lease a building in Mountain View, California which we began to occupy in the fourth quarter of 2007. We recognize rental expense on the facility on a straight line basis over the initial term of the lease. Differences between the straight line rent expense and rent payments are classified as deferred rent liability on the balance sheet. The lease for the building expires on March 31, 2018, and we have two options to extend the lease for five years each. |
License_Agreements
License Agreements | 3 Months Ended |
Mar. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License Agreements | 10. License Agreements |
Grupo Ferrer Internacional, S.A. | |
On October 5, 2011, we and Ferrer entered into the Ferrer Agreement to commercialize ADASUVE in the Ferrer Territories. Under the terms of the Ferrer Agreement, we received an upfront cash payment of $10,000,000, of which $5,000,000 was paid to the former stockholders of Allegro. The Ferrer Agreement provided for up to an additional $51,000,000 in additional milestone payments, contingent on approval of the EU Marketing Authorization Application, or MAA, certain individual country commercial sales initiations and royalty payments based on cumulative net sales targets in the Ferrer Territories. We are responsible for the MAA for ADASUVE. The MAA was submitted to the European Medicines Agency, or EMA, and was approved in February 2013 by the European Commission, or EC. We are also responsible for all post-authorization clinical studies required by the EMA and EC. Ferrer is responsible for the satisfaction of all other regulatory and pricing requirements to market and sell ADASUVE in the Ferrer Territories. Ferrer has the exclusive rights to commercialize the product in the Ferrer Territories. We supply ADASUVE to Ferrer for all of its commercial sales, and receive a specified per-unit transfer price paid in Euros. Either party may terminate the Ferrer Agreement for the other party’s uncured material breach or bankruptcy. The Ferrer Agreement continues in effect on a country-by-country basis until the later of the last to expire patent covering ADASUVE in such country or 12 years after first commercial sale. The Ferrer Agreement is subject to earlier termination in the event the parties mutually agree, by a party in the event of an uncured material breach by the other party or upon the bankruptcy or insolvency of either party. | |
In March 2012, we entered into an amendment to the Ferrer Agreement. We and Ferrer agreed to eliminate the potential MAA approval milestone payment in exchange for Ferrer’s purchase of 241,936 shares of our common stock for $12.40 per share for a total of $3,000,000, which reflected a premium on the fair value of our common stock of approximately $1,452,000 at the time of the transaction. | |
In October 2014, we entered into an amendment to the Ferrer Agreement. We and Ferrer agreed to eliminate certain individual country commercial sales initiation milestone payments in exchange for Ferrer’s purchase of 2,000,000 shares of our common stock for $4.00 per share for a total of $8,000,000, which reflected a premium on the fair value of our common stock of approximately $2,400,000. In January 2015, we paid the former shareholders of Symphony Allegro $865,000 related to this stock sale. | |
We evaluated whether the delivered elements under the Ferrer Agreement have value on a stand-alone basis and allocated revenue to the identified units of accounting based on relative fair value. We determined that the license and the development and regulatory services are a single unit of accounting as the licenses were determined not to have stand-alone value. We have begun to deliver all elements of the arrangement and are recognizing the $10,000,000 upfront payment as revenue ratably over the estimated performance period of the agreement of four years. The $1,452,000 and $2,400,000 premiums received from the sales of common stock to Ferrer are additional consideration received pursuant to the Ferrer Agreement and does not pertain to a separate deliverable or element of the arrangement, and thus is being deferred and recognized as revenue in a manner consistent with the $10,000,000 upfront payment. During the three months ended March 31, 2015 and 2014, we recognized $613,000 and $729,000, respectively, in revenue and at March 31, 2015 had deferred revenue of $4,900,000 related to the upfront payment and premium received. | |
The Ferrer Agreement, as amended, provides for us to receive up to $41,500,000 of additional payments related to first commercial sales in nine identified countries and cumulative net sales targets in the Ferrer Territories. The cumulative net sales targets will be recognized as royalty revenue when each target is earned and payable to us. The first commercial sales payments in the nine identified countries were or will be recognized utilizing the milestone method of revenue recognition. We believe each of these milestones is substantive as there is uncertainty that the milestones will be met, the milestone can only be achieved as a result of our past performance and the achievement of the milestone will result in additional payment to us. We will recognize milestone revenue upon first commercial sales in each of these identified countries. In January 2014, we recognized revenue in the amount of $1,000,000 from a milestone payment for the first product sale in Spain, of which $250,000 was paid to the former stockholders of Allegro (see Note 4). | |
Teva Pharmaceuticals USA, Inc. | |
In May 2013, we entered into the Teva Agreement to provide Teva with an exclusive license to develop and commercialize ADASUVE in the United States. Under the terms of the Teva Agreement, Teva is responsible for all U.S. development, regulatory and commercialization activities for ADASUVE, including the U.S. post-approval clinical studies and any additional clinical trials for new indications. Teva has the full right to sublicense its rights and obligations under the Teva Agreement. We are responsible for manufacturing and supplying ADASUVE to Teva for clinical trials and commercial sales. Teva has the exclusive rights to commercialize ADASUVE and AZ-104 in the United States and the co-exclusive rights, with us and our affiliates, to manufacture the product. | |
We received an upfront cash payment of $40,000,000 from Teva, $10,000,000 of which was paid to the former stockholders of Allegro. We are eligible to receive up to $195,000,000 in additional payments contingent on Teva’s successful completion of the ADASUVE post-approval studies in the United States and Teva achieving specified net sales targets. In addition to these payments, we supply ADASUVE to Teva for all of its clinical trials and commercial sales, and we receive a specified per-unit transfer price in an amount of the greater of our costs of commercial production or a specified per-unit price. Teva makes tiered royalty payments based on net commercial sales of ADASUVE in the United States. In March 2014, Teva announced the U.S. launch of ADASUVE. In March 2014, we completed a royalty securitization financing, in which we transferred certain rights to U.S. royalty and milestone payments under the Teva Agreement to a wholly-owned subsidiary. The subsidiary then sold $45,000,000 in notes backed by the royalty and milestone payments in a private placement to institutional accredited investors. The notes have no recourse to us, other than to our equity interest in our wholly-owned subsidiary, and we did not guarantee the notes. | |
Unless earlier terminated, the Teva Agreement continues in effect until the later of the last to expire patent covering ADASUVE in the United States or a specified number of years after first commercial sale. The Agreement is subject to earlier termination in the event the parties mutually agree, by a party in the event of an uncured material breach by the other party or upon the bankruptcy or insolvency of either party. Teva may also terminate the Teva Agreement in the event the FDA requires withdrawal or suspension of ADASUVE from the market due to safety reasons or, subject to a specified period of notice, for Teva’s convenience at any time following the first anniversary of the Teva Agreement. | |
We evaluated whether the delivered elements under the Teva Agreement have value on a stand-alone basis and allocated revenue to the identified units of accounting based on relative fair value. We determined that the license fees are a single unit of accounting and valued the license based on its best estimate of selling price, as VSOE and TPE of the selling price could not be determined. The selling price was estimated using discounted projected cash flows related to the licensed territory. We have delivered the license to Teva and recognized the $40,000,000 non-refundable upfront payment as revenue. | |
As described in Note 8, in connection with the Teva Agreement, we received a right-to-borrow under the Teva Note, which included the ability to draw on the Teva Note in amounts not to exceed $25,000,000, over a two year period, all of which had been drawn upon as of December 31, 2014. As outlined in Note 7, the Teva Note has a fixed conversion price and interest rate. This right-to-borrow was considered additional consideration provided by Teva to us pursuant to the Teva Agreement. | |
As noted above, we are eligible to receive up to $195,000,000 of additional payments from Teva related to Teva’s successful completion of the ADASUVE post-approval studies in the United States and Teva achieving specified net sales targets. The payments related to net sales targets will be recognized as royalty revenue when each target is earned and payable to us. The payment related to the completion of the ADASUVE post-approval studies will be recognized upon completion of the studies when the payment is earned and payable to us. |
Autoliv_Manufacturing_and_Supp
Autoliv Manufacturing and Supply Agreement | 3 Months Ended |
Mar. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Autoliv Manufacturing and Supply Agreement | 11. Autoliv Manufacturing and Supply Agreement |
In November 2007, we entered into a Manufacturing and Supply Agreement, or the Manufacture Agreement, with Autoliv relating to the commercial supply of chemical heat packages that can be incorporated into our Staccato device, or the Chemical Heat Packages. Autoliv had developed these Chemical Heat Packages for us pursuant to a development agreement between Autoliv and us. | |
Subject to certain exceptions, Autoliv has agreed to manufacture, assemble and test the Chemical Heat Packages solely for us in conformance with our specifications. We pay Autoliv a specified purchase price, which varies based on annual quantities we order, per Chemical Heat Package delivered. Upon termination of the Manufacture Agreement, we were to retain full ownership of the production equipment for commercial manufacture of the Chemical Heat Packages developed for us by Autoliv, and Autoliv’s obligations under the Manufacture Agreement will terminate in full. In December 2014, we amended the Manufacture Agreement with Autoliv, or the 2014 Amendment through which we and Autoliv are extending the Manufacturing Agreement through 2018. In addition, we have the right to engage a second source supplier and implement a manufacturing line transfer from Autoliv to manufacture and supply the Chemical Heat Packages to us or our licensees. | |
We have contracted with Autoliv, through a third-party supplier, to build one additional manufacturing cell to manufacture chemical heat packages at a cost of approximately $2.4 million, or the New Cell. The New Cell was expected to be installed at Autoliv with the cell currently being utilized by Autoliv, or the Original Cell, to be installed at a second source supplier. Due to the Original Cell no longer being utilized and the uncertainty of the timing of engaging a second source supplier (see Note 12), we recorded additional cost of goods sold of $1,381,000 in the three months ended March 31, 2015 due to the impairment of the Original Cell. The $1,381,000 impairment reduced the carrying amount of this cell to $0, which we believe is the fair value of this equipment and is a level 3 fair value measurement. The equipment is specialized and was developed specifically for the manufacture of ADASUVE and would be of limited, if any, utility to a third-party. Thus, we concluded that given the decreased projections of ADASUVE sales and the related decline in production noted below in Note 12, as well as the limited ability to sell this equipment, that its fair value is $0. The New Cell will be utilized if and when commercial production resumes. |
Manufacturing_Operations
Manufacturing Operations | 3 Months Ended |
Mar. 31, 2015 | |
Text Block [Abstract] | |
Manufacturing Operations | 12. Manufacturing Operations |
As a result of orders we requested, and Teva and Ferrer provided, we currently plan to produce ADASUVE until early in the third quarter of 2015. Once orders are filled and shipped, it is our intention to suspend ADASUVE commercial production operations. We plan for ADASUVE commercial production to resume as additional commercial product is required by Teva or Ferrer or any future partner. As we consider future commercial manufacturing strategies, we may also seek third parties who could manufacture ADASUVE units on a more efficient basis, possibly in multi-product facilities. During the three months ended March 31, 2015, we recorded additional cost of goods sold related to $1,229,000 of inventory with fixed expiration dates and $1,024,000 of prepayments made to the supplier of our lower housing assembly all of which are in excess of our expected production needs prior to the planned suspension of production operations. |
The_Company_and_Basis_of_Prese1
The Company and Basis of Presentation (Policies) | 3 Months Ended | |||
Mar. 31, 2015 | ||||
Accounting Policies [Abstract] | ||||
Basis of Presentation | Basis of Presentation | |||
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not contain all of the information and footnotes required for complete financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly our interim condensed consolidated financial information. The results for the three months ended March 31, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015 or for any other interim period or any other future year. | ||||
The accompanying unaudited condensed consolidated financial statements and notes to condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2014 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 13, 2015. | ||||
Basis of Consolidation | Basis of Consolidation | |||
The unaudited condensed consolidated financial statements include our accounts and those of our wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated. | ||||
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, 2015, we had cash, cash equivalents, marketable securities and restricted cash (see Note 4) of $23.9 million and working capital of $19.0 million. Our operating and capital plans call for cash expenditures to exceed these amounts over the next twelve months. We plan to raise additional capital to fund our operations and to develop our product candidates. We plan to finance our operations through partnership or licensing collaborations, the sale of equity securities or debt arrangements. Such funding 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 and our expected cash usage, we estimate that we have sufficient capital resources to meet our anticipated cash needs into the fourth quarter of 2015. Also, as discussed in Note 12, the Company plans to suspend manufacturing during the third quarter of 2015 in an effort to reduce its cash outflows. | |||
Revenue Recognition | 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. | ||||
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. We currently sell product through license and supply agreements with our collaborators, Grupo Ferrer Internacional, S.A., or Ferrer, and Teva Pharmaceuticals USA, Inc., or Teva. Persuasive evidence of an arrangement is generally determined by the receipt of an approved purchase order from the collaborator in connection with the terms of the related license and supply agreements. | |||
• | Delivery. Typically, ownership of the product passes to the collaborator upon shipment. Our current license and supply agreements also provide our collaborators with an acceptance period during which they may reject any product which does not conform to agreed-upon specifications. Because ADASUVE is a new product, a new technology and our first product to be commercialized, and because we do not have a history of producing product to collaborator specifications, we will not consider delivery to have occurred until after the collaborator acceptance period has ended or the collaborator has positively accepted the product. Once we have demonstrated over the course of time an ability to reliably produce the product to collaborator specifications, we will consider delivery to have occurred upon shipment in the absence of any other relevant shipment or acceptance terms. | |||
• | Sales Price Fixed or Determinable. Sales prices for product shipments are determined by the license and supply agreements and documented in the purchase orders. After the collaborator acceptance period has ended or the collaborator has positively accepted the product, our collaborators do not have any product return or replacement rights, including for expired products. | |||
• | Collectability. Payment for the product is contractually obligated under the license and supply agreements. We will monitor payment histories for our collaborators and specific issues as they arise to determine whether collection is probable for a specific transaction and defer revenue as necessary. | |||
Royalty revenue from our collaboration agreements will be recognized as we receive information from our collaborators regarding product sales and collectability is reasonably assured. | ||||
Significant management judgment is used in the determination of revenue to be recognized and the period in which it is recognized. | ||||
Inventory | 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. We are in the early stages of commercialization and have incurred significantly higher than normal indirect costs in the production of our inventory due to start-up manufacturing costs and low production volumes. 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. | ||||
Contingencies | Contingencies | |||
From time to time, we are involved in lawsuits, arbitrations, claims, investigations and proceedings that arise in the ordinary course of business. We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. No such provisions have been made for the periods presented herein. Litigation and related matters are inherently unpredictable. If any unfavorable ruling were to occur in any specific period, there exists the possibility of a material adverse impact on the results of operations of that period or on our cash flows and liquidity. | ||||
New Accounting Pronouncements | New 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. We do not believe the impact of adopting ASU 2014-15 on our results of operations or financial position. | ||||
In May 2014 the Financial Accounting Standards Board, or FASB, issued the Accounting Standards Update, or 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 the company expects 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, 2016. | ||||
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 April 2015, the Financial Accounting Standards Board tentatively decided to defer 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. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Accounting Policies [Abstract] | |||||||||
Schedule of Inventory | Inventory, which is stated at the lower of cost or estimated market value, consists of the following at March 31, 2015 and December 31, 2014 (in thousands): | ||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Raw materials | $ | 1,788 | $ | 3,677 | |||||
Work in process | 8 | — | |||||||
Finished goods | 676 | 52 | |||||||
Total inventory | $ | 2,472 | $ | 3,729 | |||||
Fair_Value_Accounting_Tables
Fair Value Accounting (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||
Financial Assets by Major Security Type and Liability Measured at Fair Value on Recurring Basis | The following table represents the fair value hierarchy for our financial assets (cash equivalents, marketable securities and restricted cash) by major security type and contingent consideration liability measured at fair value on a recurring basis as of March 31, 2015 and December 31, 2014 (in thousands): | ||||||||||||||||
March 31, 2015 | Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets | |||||||||||||||||
Money market funds | $ | 10,525 | $ | — | $ | — | $ | 10,525 | |||||||||
Corporate debt securities | — | 13,173 | — | 13,173 | |||||||||||||
Total assets | $ | 10,525 | $ | 13,173 | $ | — | $ | 23,698 | |||||||||
Liabilities | |||||||||||||||||
Contingent consideration liability | $ | — | $ | — | $ | 15,100 | $ | 15,100 | |||||||||
Total liabilities | $ | — | $ | — | $ | 15,100 | $ | 15,100 | |||||||||
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 | |||||||||
Schedule of Cash Equivalents and Marketable Securities | The amortized cost, fair value and unrealized gain/(loss) for our financial assets by major security type as of March 31, 2015 and December 31, 2014 are as follows (in thousands): | ||||||||||||||||
March 31, 2015 | Amortized | Fair Value | Unrealized | ||||||||||||||
Cost | Gain/(Loss) | ||||||||||||||||
Money market funds | $ | 10,525 | $ | 10,525 | $ | — | |||||||||||
Corporate debt securities | 13,174 | 13,173 | (1 | ) | |||||||||||||
Total | 23,699 | 23,698 | (1 | ) | |||||||||||||
Less amounts classified as restricted cash | (1,361 | ) | (1,361 | ) | — | ||||||||||||
Less amounts classified as cash equivalents | (10,910 | ) | (10,910 | ) | — | ||||||||||||
Total marketable securities | $ | 11,428 | $ | 11,427 | $ | (1 | ) | ||||||||||
December 31, 2014 | Amortized Cost | Fair Value | Unrealized | ||||||||||||||
Gain/(Loss) | |||||||||||||||||
Money market funds | $ | 12,674 | $ | 12,674 | $ | — | |||||||||||
Corporate debt securities | 24,620 | 24,617 | (3 | ) | |||||||||||||
Total | 37,294 | 37,291 | (3 | ) | |||||||||||||
Less amounts classified as restricted cash | (2,757 | ) | (2,757 | ) | — | ||||||||||||
Less amounts classified as cash equivalents | (14,960 | ) | (14,960 | ) | — | ||||||||||||
Total marketable securities | $ | 19,577 | $ | 19,574 | $ | (3 | ) | ||||||||||
Fair Value Measurement of Contingent Consideration Liability | The following table represents a reconciliation of the change in the fair value measurement of the contingent consideration liability for the three months ended March 31, 2015 and 2014 (in thousands): | ||||||||||||||||
Three Months Ended | |||||||||||||||||
March 31, | |||||||||||||||||
2015 | 2014 | ||||||||||||||||
Beginning balance | $ | 30,800 | $ | 39,200 | |||||||||||||
Payments made | (867 | ) | (250 | ) | |||||||||||||
Adjustments to fair value measurement | (14,833 | ) | 1,150 | ||||||||||||||
Ending balance | $ | 15,100 | $ | 40,100 | |||||||||||||
ShareBased_Compensation_Plans_
Share-Based Compensation Plans (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||
Summary of Option Activity under Company's Share-Based Compensation Plans | The following table sets forth the summary of option activity under our share-based compensation plans (the 2005 Equity Incentive Plan, or 2005 Plan and the 2005 Non-Employee Director Stock Award Plan, or the Directors’ Plan) for the three months ended March 31, 2015: | ||||||||
Outstanding Options | |||||||||
Number of | Weighted | ||||||||
Shares | Average | ||||||||
Exercise Price | |||||||||
Outstanding at January 1, 2015 | 1,978,273 | $ | 7.1 | ||||||
Options granted | 52,500 | 1.94 | |||||||
Options exercised | — | — | |||||||
Options canceled | (182,521 | ) | 5.19 | ||||||
Outstanding at March 31, 2015 | 1,848,252 | 7.14 | |||||||
Summary of Restricted Stock Units, or RSUs, Activity under Company's Share-Based Compensation Plans | The following table sets forth the summary of restricted stock units, or RSUs, activity under our share-based compensation plans for the three months ended March 31, 2015: | ||||||||
Number | Weighted | ||||||||
Of | Average | ||||||||
Shares | Grant-Date | ||||||||
Fair Value | |||||||||
Outstanding at January 1, 2014 | 81,050 | $ | 4.67 | ||||||
Granted | — | — | |||||||
Released | — | — | |||||||
Forfeited | (2,925 | ) | 4.67 | ||||||
Outstanding at March 31, 2015 | 78,125 | $ | 4.67 | ||||||
ShareBased_Compensation_Tables
Share-Based Compensation (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||
Weighted Average Fair Value of Employee Stock Options Granted | During the three months ended March 31, 2015 and 2014, the per share weighted average fair value of employee stock options granted were as follows: | ||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Stock options | $ | 1.29 | $ | 3.69 | |||||
Restricted stock units | — | — | |||||||
Stock purchase rights | 0.67 | 2.03 | |||||||
Estimated Grant Date Fair Values of Stock Options with Weighted Average Assumptions | The estimated grant date fair values of the stock options and stock purchase rights were calculated using the Black-Scholes valuation model, and the following weighted average assumptions: | ||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Stock Option Plans | |||||||||
Expected term | 5.0 years | 5.0 years | |||||||
Expected volatility | 85 | % | 87 | % | |||||
Risk-free interest rate | 1.4 | % | 1.54 | % | |||||
Dividend yield | 0 | % | 0 | % | |||||
Employee Stock Purchase Plan | |||||||||
Expected term | 0.5 years | 0.5 years | |||||||
Expected volatility | 60 | % | 92 | % | |||||
Risk-free interest rate | 1.62 | % | 1.37 | % | |||||
Dividend yield | 0 | % | 0 | % |
Net_Loss_per_Share_Tables
Net Loss per Share (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Earnings Per Share [Abstract] | |||||||||
Anti-Dilutive Securities Excluded from Net Loss per Share | The following items were excluded in the net loss per share calculation for the three months ended March 31, 2015 and 2014 because the inclusion of such items would have had an anti-dilutive effect: | ||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Stock options | 1,913,263 | 2,216,410 | |||||||
Restricted stock units | 79,588 | 499,175 | |||||||
Warrants to purchase common stock | 5,918,943 | 6,634,897 | |||||||
Convertible debt | 5,382,363 | 3,933,151 |
Financing_Obligations_Tables
Financing Obligations (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||
Schedule of Effective Interest Rate Drawdown after Taking into Consideration Beneficial Ownership Features and Right to Borrow Asset Discount | The following table shows the effective interest rate for each drawdown after taking into consideration the beneficial ownership features and the right-to-borrow asset discount. | ||||||||||||||||
Draw | Beneficial | Reclassified | Effective | ||||||||||||||
Amount | Conversion | Unamortized | Interest | ||||||||||||||
Feature | Right-to- | Rate | |||||||||||||||
Borrow | |||||||||||||||||
Sep-13 | $ | 10,000,000 | $ | 2,455,000 | $ | 900,000 | 14.2 | % | |||||||||
Dec-13 | 5,000,000 | 657,000 | 393,000 | 10.2 | % | ||||||||||||
Mar-14 | 5,000,000 | 883,000 | 318,000 | 11.6 | % | ||||||||||||
Jun-14 | 5,000,000 | 148,000 | 252,000 | 6.6 | % | ||||||||||||
Long Term Debt Payments by Year | Future scheduled principal payments under our various debt obligations as of March 31, 2015 are as follows (in thousands): | ||||||||||||||||
Total | |||||||||||||||||
2015 - remaining 9 months | — | ||||||||||||||||
2016 | — | ||||||||||||||||
2017 | — | ||||||||||||||||
2018 | 25,000 | ||||||||||||||||
Thereafter | — | ||||||||||||||||
Total | $ | 25,000 | |||||||||||||||
The_Company_and_Basis_of_Prese2
The Company and Basis of Presentation - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2015 | |
Segment | |
Equity [Abstract] | |
Business incorporation, state country name | State of Delaware |
Business incorporation, date | 19-Dec-00 |
Number of business segment | 1 |
Need_to_Raise_Additional_Capit1
Need to Raise Additional Capital - Additional Information (Detail) (USD $) | 3 Months Ended |
In Millions, unless otherwise specified | Mar. 31, 2015 |
Need To Raise Additional Capital Textual [Abstract] | |
Cash, cash equivalents, marketable securities and restricted cash | $23.90 |
Working capital | $19 |
Operating and capital plans | Next twelve months |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies - Schedule of Inventory (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 | |
In Thousands, unless otherwise specified | |||
Inventory Disclosure [Abstract] | |||
Raw materials | $1,788 | $3,677 | |
Work in process | 8 | 0 | |
Finished goods | 676 | 52 | |
Total inventory | $2,472 | $3,729 | [1] |
[1] | (1) The condensed consolidated balance sheet at December 31, 2014 has been derived from audited consolidated financial statements at that date. |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | Mar. 31, 2015 |
Inventory Disclosure [Abstract] | |
Reserve related to raw materials | $1,229,000 |
Fair_Value_Accounting_Financia
Fair Value Accounting - Financial Assets by Major Security Type and Liability Measured at Fair Value on Recurring Basis (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Assets | ||
Cash and cash equivalents, fair value disclosure | $10,910 | $14,960 |
Total assets | 23,698 | 37,291 |
Liabilities | ||
Contingent consideration liability | 15,100 | 30,800 |
Total liabilities | 15,100 | 30,800 |
Money market funds [Member] | ||
Assets | ||
Cash and cash equivalents, fair value disclosure | 10,525 | 12,674 |
Corporate debt securities [Member] | ||
Assets | ||
Cash and cash equivalents, fair value disclosure | 13,173 | 24,617 |
Level 1 [Member] | ||
Assets | ||
Total assets | 10,525 | 12,674 |
Liabilities | ||
Contingent consideration liability | 0 | 0 |
Total liabilities | 0 | 0 |
Level 1 [Member] | Money market funds [Member] | ||
Assets | ||
Cash and cash equivalents, fair value disclosure | 10,525 | 12,674 |
Level 1 [Member] | Corporate debt securities [Member] | ||
Assets | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
Level 2 [Member] | ||
Assets | ||
Total assets | 13,173 | 24,617 |
Liabilities | ||
Contingent consideration liability | 0 | 0 |
Total liabilities | 0 | 0 |
Level 2 [Member] | Money market funds [Member] | ||
Assets | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
Level 2 [Member] | Corporate debt securities [Member] | ||
Assets | ||
Cash and cash equivalents, fair value disclosure | 13,173 | 24,617 |
Level 3 [Member] | ||
Assets | ||
Total assets | 0 | 0 |
Liabilities | ||
Contingent consideration liability | 15,100 | 30,800 |
Total liabilities | 15,100 | 30,800 |
Level 3 [Member] | Money market funds [Member] | ||
Assets | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
Level 3 [Member] | Corporate debt securities [Member] | ||
Assets | ||
Cash and cash equivalents, fair value disclosure | $0 | $0 |
Fair_Value_Accounting_Schedule
Fair Value Accounting - Schedule of Cash Equivalents and Marketable Securities (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 | |
In Thousands, unless otherwise specified | |||
Cash Cash Equivalents And Investments [Line Items] | |||
Amortized Cost | $11,428 | $19,577 | |
Fair Value | 11,427 | 19,574 | [1] |
Unrealized Gain/(Loss) | -1 | -3 | |
Less amounts classified as restricted cash, Amortized Cost | -1,361 | -2,757 | |
Less amounts classified as restricted cash, Fair Value | -1,361 | -2,757 | |
Less amounts classified as cash equivalents, Amortized Cost | -10,910 | -14,960 | |
Less amounts classified as cash equivalents, Fair Value | -10,910 | -14,960 | |
Less amounts classified as cash equivalents, Unrealized Gain/(Loss) | 0 | 0 | |
Money market funds [Member] | |||
Cash Cash Equivalents And Investments [Line Items] | |||
Amortized Cost | 10,525 | 12,674 | |
Fair Value | 10,525 | 12,674 | |
Unrealized Gain/(Loss) | 0 | 0 | |
Less amounts classified as cash equivalents, Fair Value | -10,525 | -12,674 | |
Corporate debt securities [Member] | |||
Cash Cash Equivalents And Investments [Line Items] | |||
Amortized Cost | 13,174 | 24,620 | |
Fair Value | 13,173 | 24,617 | |
Unrealized Gain/(Loss) | -1 | -3 | |
Less amounts classified as cash equivalents, Fair Value | -13,173 | -24,617 | |
Total [Member] | |||
Cash Cash Equivalents And Investments [Line Items] | |||
Amortized Cost | 23,699 | 37,294 | |
Fair Value | 23,698 | 37,291 | |
Unrealized Gain/(Loss) | ($1) | ($3) | |
[1] | (1) The condensed consolidated balance sheet at December 31, 2014 has been derived from audited consolidated financial statements at that date. |
Fair_Value_Accounting_Addition
Fair Value Accounting - Additional Information (Detail) (USD $) | 3 Months Ended | ||
Mar. 31, 2015 | Dec. 31, 2014 | Mar. 31, 2014 | |
Fair Value Disclosures [Abstract] | |||
Sales of marketable securities | $0 | $0 | |
Cash flow discount rate | 20.00% | 16.50% | |
Increase (decrease) in net loss | -14,833,000 | 1,150,000 | |
Increase (decrease) in net loss per share | ($0.75) | $0.07 | |
Estimated fair value of financing obligations | 51,581,000 | 52,075,000 | |
Book values of financing obligations | $64,157,000 | $63,767,000 |
Fair_Value_Accounting_Fair_Val
Fair Value Accounting - Fair Value Measurement of Contingent Consideration Liability (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Fair Value Disclosures [Abstract] | ||
Beginning balance | $30,800 | $39,200 |
Payments made | -867 | -250 |
Adjustments to fair value measurement | -14,833 | 1,150 |
Ending balance | $15,100 | $40,100 |
ShareBased_Compensation_Plans_1
Share-Based Compensation Plans - Summary of Option Activity under Company's Share-Based Compensation Plans (Detail) (USD $) | 3 Months Ended |
Mar. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Outstanding at January 1, 2015, Number of Shares | 1,978,273 |
Options granted, Number of Shares | 52,500 |
Options exercised, Number of Shares | 0 |
Options canceled, Number of Shares | -182,521 |
Outstanding at March 31, 2015, Number of Shares | 1,848,252 |
Outstanding at January 1, 2015, Weighted Average Exercise Price | $7.10 |
Options granted, Weighted Average Exercise Price | $1.94 |
Options exercised, Weighted Average Exercise Price | $0 |
Options canceled, Weighted Average Exercise Price | $5.19 |
Outstanding at March 31, 2015, Weighted Average Exercise Price | $7.14 |
ShareBased_Compensation_Plans_2
Share-Based Compensation Plans - Additional Information (Detail) (USD $) | 3 Months Ended | 0 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Jan. 01, 2015 | Jan. 01, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Intrinsic value of options exercised | $5,000 | |||
Options exercised | 0 | |||
2005 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Authorized shares of common stock for issuance, Number of Shares | 100,000 | 100,000 | ||
Shares available for issuance | 1,886,906 | |||
2005 Non-Employee Director's Stock Option Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Authorized shares of common stock for issuance, Number of Shares | 75,000 | 58,751 | ||
Shares available for issuance | 225,000 | |||
2005 Employee Stock Purchase Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares available for issuance | 0 | 0 | ||
Shares issued under ESPP | 75,000 | 75,000 | ||
Shares available for issuance under the ESPP | 154,406 | |||
Restricted stock units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares vested but unreleased | 0 |
ShareBased_Compensation_Plans_3
Share-Based Compensation Plans - Summary of Restricted Stock Units, or RSUs, Activity under Company's Share-Based Compensation Plans (Detail) (Restricted stock units [Member], USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Restricted stock units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding at January 1, 2015, Number Of Shares | 81,050 | |
Granted, Number Of Shares | 0 | |
Released, Number Of Shares | 0 | |
Forfeited, Number Of Shares | -2,925 | |
Outstanding at March 31, 2015, Number Of Shares | 78,125 | |
Outstanding at January 1, 2015, Weighted Average Grant-Date Fair Value | $4.67 | |
Granted, Weighted Average Grant-Date Fair Value | $0 | $0 |
Released, Weighted Average Grant-Date Fair Value | $0 | |
Forfeited, Weighted Average Grant-Date Fair Value | $4.67 | |
Outstanding at March 31, 2015, Weighted Average Grant-Date Fair Value | $4.67 |
ShareBased_Compensation_Weight
Share-Based Compensation - Weighted Average Fair Value of Employee Stock Options Granted (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock options | $1.29 | $3.69 |
Restricted stock units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Restricted stock units or Stock purchase rights | $0 | $0 |
Stock Purchase Rights [Member] | Employee Stock Purchase Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Restricted stock units or Stock purchase rights | $0.67 | $2.03 |
ShareBased_Compensation_Estima
Share-Based Compensation - Estimated Grant Date Fair Values of Stock Options with Weighted Average Assumptions (Detail) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Stock Option Plans [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 5 years | 5 years |
Expected volatility | 85.00% | 87.00% |
Risk-free interest rate | 1.40% | 1.54% |
Dividend yield | 0.00% | 0.00% |
Employee Stock Purchase Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 6 months | 6 months |
Expected volatility | 60.00% | 92.00% |
Risk-free interest rate | 1.62% | 1.37% |
Dividend yield | 0.00% | 0.00% |
ShareBased_Compensation_Additi
Share-Based Compensation - Additional Information (Detail) (USD $) | 3 Months Ended |
Mar. 31, 2015 | |
Restricted stock units [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Dividends will be paid prior to the vesting of the restricted stock unit | $0 |
Employee Stock Purchase Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Total unrecognized compensation expense | 3,000 |
Expenses expected to be recognized over a weighted average period | 1 month 6 days |
Restricted stock unit awards [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Total unrecognized compensation expense | 290,000 |
Expenses expected to be recognized over a weighted average period | 1 year 10 months 24 days |
Stock options [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Total unrecognized compensation expense related to unvested stock option awards | $2,564,000 |
Expenses expected to be recognized over a weighted average period | 2 years 6 months |
Net_Loss_per_Share_AntiDilutiv
Net Loss per Share - Anti-Dilutive Securities Excluded from Net Loss per Share (Detail) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Stock options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 1,913,263 | 2,216,410 |
Restricted stock units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 79,588 | 499,175 |
Warrants to purchase common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 5,918,943 | 6,634,897 |
Convertible debt [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 5,382,363 | 3,933,151 |
Financing_Obligations_Addition
Financing Obligations - Additional Information (Detail) (USD $) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Mar. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 | Jun. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Dec. 31, 2014 | 31-May-13 | |
Debt Instrument [Line Items] | ||||||||
Borrowing under loan agreement | $0 | $45,829,000 | ||||||
Non-recourse notes issued | 45,000,000 | |||||||
Warrants to purchase common stock | 345,661 | 345,661 | ||||||
Price of common stock per share | $0.01 | $0.01 | ||||||
Warrant exercisable term | 5 years | |||||||
Effective interest rate of notes | 12.25% | 12.25% | ||||||
First quarterly interest payment | 15-Jun-14 | |||||||
Notes redemption description | The Notes have no other recourse to us. The Notes may not be redeemed at our option until after March 18, 2016, and may be redeemed after that date subject to the achievement of certain milestones and the payment of a redemption premium for any redemption occurring prior to March 19, 2019. | |||||||
Interest reserve | 6,890,000 | 1,361,000 | 6,890,000 | |||||
Estimated life of the warrant | 5 years | |||||||
Expected volatility rate | 87.00% | |||||||
Risk-free interest rate | 1.54% | |||||||
Expected dividend yield | 0.00% | |||||||
Interest expense amortization period | 5 years | |||||||
Total value of warrants | 1,721,000 | 0 | 1,721,000 | |||||
Total fees and expenses | 4,171,000 | |||||||
Financing from royalty securitization | 45,000,000 | |||||||
Royalty securitization financing legal maturity date | 2027 | |||||||
Teva Pharmaceuticals USA, Inc. [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Aggregate term loan advances | 25,000,000 | |||||||
Debt instrument payment terms | We may prepay, from time to time, up to one-half of the total amounts advanced plus the related interest outstanding at any time prior to the maturity date. At any time prior to five days before the maturity date, Teva will have the right to convert the then outstanding amounts into shares of our common stock at a conversion price of $4.4833 per share. | |||||||
Debt instrument conversion price per share | $4.48 | |||||||
Debt instrument interest rate | 4.00% | |||||||
Borrowing under loan agreement | 5,000,000 | 5,000,000 | 5,000,000 | 10,000,000 | 25,000,000 | |||
Interest expense under right-to-borrow asset | $216,000 | |||||||
Effective interest rate of notes | 11.60% | 11.60% | 6.60% | 10.20% | 14.20% |
Financing_Obligations_Schedule
Financing Obligations - Schedule of Effective Interest Rate Drawdown after Taking into Consideration Beneficial Ownership Features and Right to Borrow Asset Discount (Detail) (USD $) | 3 Months Ended | 12 Months Ended | ||||
Mar. 31, 2015 | Mar. 31, 2014 | Jun. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Dec. 31, 2014 | |
Debt Instrument [Line Items] | ||||||
Draw Amount | $0 | $45,829,000 | ||||
Beneficial Conversion Feature | 0 | 883,000 | ||||
Effective Interest Rate | 12.25% | |||||
Teva Pharmaceuticals USA, Inc. [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Draw Amount | 5,000,000 | 5,000,000 | 5,000,000 | 10,000,000 | 25,000,000 | |
Beneficial Conversion Feature | 883,000 | 148,000 | 657,000 | 2,455,000 | ||
Reclassified Unamortized Right-to-Borrow | $318,000 | $252,000 | $393,000 | $900,000 | ||
Effective Interest Rate | 11.60% | 6.60% | 10.20% | 14.20% |
Financing_Obligations_Long_Ter
Financing Obligations - Long Term Debt Payments by Year (Detail) (USD $) | Mar. 31, 2015 |
In Thousands, unless otherwise specified | |
Debt Disclosure [Abstract] | |
2015 - remaining 9 months | $0 |
2016 | 0 |
2017 | 0 |
2018 | 25,000 |
Thereafter | 0 |
Total | $25,000 |
Facility_Leases_Additional_Inf
Facility Leases - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2015 | |
Lease | |
Leases [Abstract] | |
Expiry of lease of Building | 31-Mar-18 |
Operating leases maturity period | 5 years |
Number of lease renewal options | 2 |
License_Agreements_Additional_
License Agreements - Additional Information (Detail) (USD $) | 3 Months Ended | 0 Months Ended | 1 Months Ended | 0 Months Ended | 1 Months Ended | 12 Months Ended | |||||
Mar. 31, 2015 | Mar. 31, 2014 | Oct. 05, 2011 | Oct. 31, 2014 | Jan. 31, 2014 | Mar. 31, 2012 | Jan. 31, 2015 | Oct. 31, 2014 | Mar. 31, 2012 | 31-May-13 | Dec. 31, 2014 | |
License Agreements [Line Items] | |||||||||||
Revenue under agreement | $618,000 | $1,728,000 | |||||||||
Grupo Ferrer Internacional, S.A. [Member] | |||||||||||
License Agreements [Line Items] | |||||||||||
Upfront cash received under collaborative arrangement | 10,000,000 | ||||||||||
Eligible receipt of additional milestone payments | 41,500,000 | 51,000,000 | |||||||||
License agreement contractual terms | Until the later of the last to expire patent covering ADASUVE in such country or 12 years after first commercial sale. | ||||||||||
License agreement term period | 12 years | ||||||||||
Aggregate purchase price | 2,000,000 | 241,936 | |||||||||
Purchase of common stock, value | 8,000,000 | 3,000,000 | |||||||||
Common stock price, per share | $4 | $12.40 | $4 | $12.40 | |||||||
Estimated performance period of agreement | 4 years | ||||||||||
Revenue under agreement | 613,000 | 729,000 | |||||||||
Deferred revenue | 4,900,000 | ||||||||||
Upfront cash received under collaborative arrangement | 1,000,000 | ||||||||||
Grupo Ferrer Internacional, S.A. [Member] | Symphony Allegro [Member] | |||||||||||
License Agreements [Line Items] | |||||||||||
Payment related to common stock | 865,000 | ||||||||||
Grupo Ferrer Internacional, S.A. [Member] | Private Placement [Member] | |||||||||||
License Agreements [Line Items] | |||||||||||
Premium on the fair value from sale of stock, classified as deferred revenue | 2,400,000 | 1,452,000 | |||||||||
Grupo Ferrer Internacional, S.A. [Member] | Allegro stockholders [Member] | |||||||||||
License Agreements [Line Items] | |||||||||||
Payments to former stockholders under collaborative arrangement | 5,000,000 | 250,000 | |||||||||
Teva Pharmaceuticals USA, Inc. [Member] | |||||||||||
License Agreements [Line Items] | |||||||||||
Upfront cash received under collaborative arrangement | 40,000,000 | ||||||||||
Eligible receipt of additional milestone payments | 195,000,000 | ||||||||||
Sale of notes backed by royalty and milestone payments | 45,000,000 | ||||||||||
Guarantee of notes | The notes have no recourse to us, other than to our equity interest in our wholly-owned subsidiary, and we did not guarantee the notes. | ||||||||||
Aggregate term loan advances | 25,000,000 | ||||||||||
Number of years from effective date to receive note advances | 2 years | ||||||||||
Eligible receipt of additional payments | 195,000,000 | ||||||||||
Teva Pharmaceuticals USA, Inc. [Member] | Allegro stockholders [Member] | |||||||||||
License Agreements [Line Items] | |||||||||||
Payments to former stockholders under collaborative arrangement | $10,000,000 |
Autoliv_Manufacturing_and_Supp1
Autoliv Manufacturing and Supply Agreement - Additional Information (Detail) (Autoliv ASP, Inc. [Member], USD $) | 3 Months Ended |
Mar. 31, 2015 | |
Autoliv ASP, Inc. [Member] | |
Debt Instrument [Line Items] | |
Agreement termination year | 2018 |
Additional manufacturing cell cost | $2,400,000 |
Additional cost of goods sold recorded | 1,381,000 |
Equipment carrying value | 0 |
Equipment fair value | $0 |
Manufacturing_Operations_Addit
Manufacturing Operations - Additional Information (Detail) (USD $) | 3 Months Ended |
Mar. 31, 2015 | |
Inventory Disclosure [Abstract] | |
Additional cost of goods sold related to inventory | $1,229,000 |
Prepayments to supplier for lower housing assembly | $1,024,000 |