Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Jan. 31, 2014 | Mar. 03, 2014 | |
Document And Entity Information | ' | ' |
Entity Registrant Name | 'PEREGRINE PHARMACEUTICALS INC | ' |
Entity Central Index Key | '0000704562 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 31-Jan-14 | ' |
Amendment Flag | 'false | ' |
Current Fiscal Year End Date | '--04-30 | ' |
Is Entity a Well-known Seasoned Issuer? | 'No | ' |
Is Entity a Voluntary Filer? | 'No | ' |
Is Entity's Reporting Status Current? | 'Yes | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 176,481,054 |
Document Fiscal Period Focus | 'Q3 | ' |
Document Fiscal Year Focus | '2014 | ' |
CONDENSED_CONSOLIDATED_BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (USD $) | Jan. 31, 2014 | Apr. 30, 2013 |
CURRENT ASSETS: | ' | ' |
Cash and cash equivalents | $63,177,000 | $35,204,000 |
Trade and other receivables, net | 2,782,000 | 1,662,000 |
Inventories | 5,224,000 | 4,339,000 |
Prepaid expenses and other current assets, net | 1,050,000 | 709,000 |
Total current assets | 72,233,000 | 41,914,000 |
Property and equipment, net | 2,514,000 | 2,678,000 |
Other assets | 1,738,000 | 466,000 |
TOTAL ASSETS | 76,485,000 | 45,058,000 |
CURRENT LIABILITIES: | ' | ' |
Accounts payable | 1,879,000 | 2,821,000 |
Accrued clinical trial and related fees | 1,358,000 | 930,000 |
Accrued payroll and related costs | 3,309,000 | 3,582,000 |
Deferred revenue, current portion | 4,329,000 | 4,171,000 |
Customer deposits | 8,646,000 | 8,059,000 |
Other current liabilities | 1,228,000 | 998,000 |
Total current liabilities | 20,749,000 | 20,561,000 |
Deferred revenue, less current portion | 292,000 | 292,000 |
Other long-term liabilities | 373,000 | 445,000 |
Commitments and contingencies (Note 11) | ' | ' |
STOCKHOLDERS' EQUITY: | ' | ' |
Preferred stock-$0.001 par value; authorized 5,000,000 shares; non-voting; nil shares outstanding | 0 | 0 |
Common stock-$0.001 par value; authorized 325,000,000 shares; outstanding - 176,453,261 and 143,768,946, respectively | 176,000 | 143,000 |
Additional paid-in-capital | 447,913,000 | 391,521,000 |
Accumulated deficit | -393,018,000 | -367,904,000 |
Total stockholders' equity | 55,071,000 | 23,760,000 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $76,485,000 | $45,058,000 |
CONDENSED_CONSOLIDATED_BALANCE1
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Jan. 31, 2014 | Apr. 30, 2013 |
Statement of Financial Position [Abstract] | ' | ' |
Preferred stock par value (in Dollars per share) | $0.00 | $0.00 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock par value (in Dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized | 325,000,000 | 325,000,000 |
Common stock, shares outstanding | 176,453,261 | 143,768,946 |
Common stock, shares issued | 176,453,261 | 143,768,946 |
CONDENSED_CONSOLIDATED_STATEME
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
Jan. 31, 2014 | Jan. 31, 2013 | Jan. 31, 2014 | Jan. 31, 2013 | |
REVENUES: | ' | ' | ' | ' |
Contract manufacturing revenue | $3,885,000 | $6,961,000 | $15,820,000 | $17,157,000 |
License revenue | 0 | 78,000 | 107,000 | 272,000 |
Total revenues | 3,885,000 | 7,039,000 | 15,927,000 | 17,429,000 |
COSTS AND EXPENSES: | ' | ' | ' | ' |
Cost of contract manufacturing | 2,416,000 | 3,651,000 | 9,281,000 | 9,378,000 |
Research and development | 6,649,000 | 5,437,000 | 18,910,000 | 18,471,000 |
Selling, general and administrative | 4,563,000 | 3,112,000 | 12,913,000 | 9,469,000 |
Total costs and expenses | 13,628,000 | 12,200,000 | 41,104,000 | 37,318,000 |
LOSS FROM OPERATIONS | -9,743,000 | -5,161,000 | -25,177,000 | -19,889,000 |
OTHER INCOME (EXPENSE): | ' | ' | ' | ' |
Interest and other income | 23,000 | 255,000 | 68,000 | 307,000 |
Interest and other expense | -4,000 | -8,000 | -5,000 | -53,000 |
Loss on early extinguishment of debt | 0 | 0 | 0 | -1,696,000 |
NET LOSS | -9,724,000 | -4,914,000 | -25,114,000 | -21,331,000 |
COMPREHENSIVE LOSS | ($9,724,000) | ($4,914,000) | ($25,114,000) | ($21,331,000) |
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING, Basic and diluted | 163,223,767 | 131,489,994 | 156,521,874 | 114,726,569 |
BASIC AND DILUTED LOSS PER COMMON SHARE | ($0.06) | ($0.04) | ($0.16) | ($0.19) |
CONDENSED_CONSOLIDATED_STATEME1
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (USD $) | 9 Months Ended | |
Jan. 31, 2014 | Jan. 31, 2013 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ' | ' |
Net loss | ($25,114,000) | ($21,331,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Share-based compensation | 4,914,000 | 2,320,000 |
Depreciation and amortization | 737,000 | 806,000 |
Loss on early extinguishment of debt | 0 | 1,696,000 |
Loss on disposal of property and equipment | 4,000 | 8,000 |
Changes in operating assets and liabilities: | ' | ' |
Trade and other receivables, net | -1,120,000 | 370,000 |
Inventories | -885,000 | -1,024,000 |
Prepaid expenses and other current assets, net | -341,000 | -83,000 |
Other non-current assets | -50,000 | 2,000 |
Accounts payable | -976,000 | -1,883,000 |
Accrued clinical trial and related fees | 428,000 | -633,000 |
Accrued payroll and related expenses | -273,000 | 481,000 |
Deferred revenue | 158,000 | 1,341,000 |
Customer deposits | 587,000 | 1,864,000 |
Other accrued expenses and current liabilities | 258,000 | -64,000 |
Other long-term liabilities | -72,000 | -80,000 |
Net cash used in operating activities | -21,745,000 | -16,210,000 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ' | ' |
Property and equipment acquisitions | -543,000 | -686,000 |
Increase in other assets | -1,222,000 | -55,000 |
Net cash used in investing activities | -1,765,000 | -741,000 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ' | ' |
Proceeds from issuance of common stock, net of issuance costs of $1,427,000 and $885,000, respectively | 50,980,000 | 26,166,000 |
Proceeds from issuance of notes payable, net of issuance costs of $251,000 | 0 | 14,749,000 |
Proceeds from issuance of common stock under Employee Stock Purchase Plan | 282,000 | 214,000 |
Proceeds from exercise of stock options | 249,000 | 77,000 |
Principal payments on notes payable | 0 | -15,000,000 |
Payment of final fee on notes payable | 0 | -975,000 |
Principal payments on capital leases | -28,000 | -58,000 |
Net cash provided by financing activities | 51,483,000 | 25,173,000 |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 27,973,000 | 8,222,000 |
CASH AND CASH EQUIVALENTS, beginning of period | 35,204,000 | 18,033,000 |
CASH AND CASH EQUIVALENTS, end of period | 63,177,000 | 26,255,000 |
SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ' | ' |
Accounts payable for purchase of property and equipment | 34,000 | 11,000 |
Fair market value of warrants issued in connection with notes payable | $0 | $470,000 |
CONDENSED_CONSOLIDATED_STATEME2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) (USD $) | 9 Months Ended | |
Jan. 31, 2014 | Jan. 31, 2013 | |
Statement of Cash Flows [Abstract] | ' | ' |
Common stock issuance costs | $1,427,000 | $885,000 |
Note payable issuance costs | $0 | $251,000 |
1_ORGANIZATION_AND_BUSINESS
1. ORGANIZATION AND BUSINESS | 9 Months Ended |
Jan. 31, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' |
1. ORGANIZATION AND BUSINESS | ' |
Peregrine Pharmaceuticals, Inc. (“Peregrine”, “we”, “us”, “our” or the “Company”) is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials focused on the treatment and diagnosis of cancer. We are advancing our lead immunotherapy candidate, bavituximab, in Phase III development for the treatment of second-line non-small cell lung cancer (the “SUNRISE trial”) while also seeking a licensing or funding partner to further advance Cotara into Phase III development for the treatment of brain cancer. In addition, we are evaluating our lead molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (“Avid”), a contract manufacturing organization that provides development and biomanufacturing services for Peregrine and its third-party clients. |
2_SUMMARY_OF_SIGNIFICANT_ACCOU
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended | ||
Jan. 31, 2014 | |||
Accounting Policies [Abstract] | ' | ||
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' | ||
Basis of Presentation | |||
The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) related to quarterly reports on Form 10-Q. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for a complete set of financial statements. These interim unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended April 30, 2013. The condensed consolidated balance sheet at April 30, 2013, has been derived from audited financial statements at that date. The unaudited financial information for the interim periods presented herein reflects all adjustments which, in the opinion of management, are necessary for a fair presentation of the financial condition and results of operations for the periods presented, with such adjustments consisting only of normal recurring adjustments. Results of operations for interim periods covered by this quarterly report on Form 10-Q may not necessarily be indicative of results of operations for the full fiscal year. | |||
The interim unaudited condensed consolidated financial statements include the accounts of Peregrine and Avid. All intercompany accounts and transactions have been eliminated in the interim unaudited condensed consolidated financial statements. | |||
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts, as well as disclosures of commitments and contingencies in the financial statements and accompanying notes. Actual results could differ from those estimates. | |||
Adoption of Recent Accounting Pronouncements | |||
Effective May 1, 2013, we adopted Financial Accounting Standards Board’s (“FASB”) Accounting Standards Update (“ASU”) No. 2013-02, Other Comprehensive Income (Topic 220): Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income. ASU No. 2013-02 does not change the current requirements for reporting net income or other comprehensive income in financial statements, however, it does require an entity to report the effect of significant reclassifications out of accumulated other comprehensive income on the respective line items in net income if the amounts are required to be reclassified in their entirety to net income. For other amounts that are not required to be reclassified in their entirety to net income in the same reporting period, an entity is required to cross-reference to other disclosures that provide additional detail about those amounts. The adoption ASU No. 2013-02 did not have a material impact on our consolidated financial statements. | |||
Pending Adoption of Recent Accounting Pronouncements | |||
In July 2013, the FASB issued ASU No. 2013-11, Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists. ASU No. 2013-11 requires entities to present in the financial statements an unrecognized tax benefit, or a portion of an unrecognized tax benefit as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward except to the extent such items are not available or not intended to be used at the reporting date to settle any additional income taxes that would result from the disallowance of a tax position. In such instances, the unrecognized tax benefit is required to be presented in the financial statements as a liability and not be combined with deferred tax assets. This guidance is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013, which will be our fiscal year 2015 (or May 1, 2014). We do not expect the adoption of this guidance to have a material impact on our consolidated financial statements. | |||
Liquidity and Financial Condition | |||
At January 31, 2014, we had $63,177,000 in cash and cash equivalents. We have expended substantial funds on the research and development of our product candidates, and funding the operations of Avid. As a result, we have historically experienced negative cash flows from operations since our inception and we expect negative cash flows from operations to continue in the foreseeable future. Our net loss incurred during the nine-month period ended January 31, 2014 amounted to $25,114,000 and our net losses incurred during the past three fiscal years ended April 30, 2013, 2012 and 2011, amounted to $29,780,000, $42,119,000, and $34,151,000, respectively. Therefore, unless and until we are able to generate sufficient revenues from Avid’s contract manufacturing services and/or from the sale and/or licensing of our products under development, we expect such losses to continue in the foreseeable future. | |||
Therefore, our ability to continue to fund our clinical trials and development efforts is highly dependent on the amount of cash and cash equivalents on hand combined with our ability to raise additional capital to support our future operations through one or more methods, including but not limited to, raising additional capital in the equity markets, securing debt financing, licensing or partnering our products in development, or generating additional revenue from Avid. | |||
Historically, we have funded a significant portion of our operations through the issuance of equity. During the nine months ended January 31, 2014, we raised $52,407,000 in aggregate gross proceeds from the sale of shares of our common stock under an At Market Sales Issuance Agreement (Note 7). In February 2014, we raised an additional $19,375,000 in aggregate gross proceeds in connection with a firm commitment underwritten public offering of our newly designated 10.50% Series E Convertible Preferred Stock (the “Series E Preferred Stock”) at a public offering price of $25.00 per share (Note 12). With these proceeds, we currently estimate that we have sufficient cash resources to meet our anticipated cash needs to fund our operations through at least the next twelve months based on our current projections, which includes projected costs associated with our pivotal Phase III SUNRISE trial, projected cash outflows for the payment of dividends on our Series E Preferred Stock, projected cash inflows under signed contracts with existing customers of Avid and assuming we raise no additional capital from the capital markets or other potential sources. | |||
Our ability to raise additional capital in the equity markets to fund our clinical trials and development efforts in future years is dependent on a number of factors, including, but not limited to, the market demand for our common stock and/or Series E Preferred Stock. The market demand or liquidity of our common stock and/or Series E Preferred Stock is subject to a number of risks and uncertainties, including but not limited to, negative economic conditions, adverse market conditions, adverse clinical trial results and significant delays in one or more clinical trials. If our ability to access the capital markets becomes severely restricted, it could have a negative impact on our business plans, including our clinical trial programs and other research and development activities. In addition, even if we are able to raise additional capital, it may not be at a price or on terms that are favorable to us. | |||
While we will continue to explore these potential opportunities, we may not be successful in (i) raising additional capital in the equity markets, (ii) securing debt financing, (iii) licensing or partnering our products in development, or (iv) generating additional revenue from Avid, to complete the research, development, and clinical testing of our product candidates. | |||
Revenue Recognition | |||
We currently derive revenue from two sources: (i) contract manufacturing services provided by Avid, and (ii) licensing revenues related to agreements associated with Peregrine’s technologies under development. | |||
We recognize revenue in accordance with the authoritative guidance for revenue recognition. We recognize revenue when all of the following criteria are met: (i) persuasive evidence of an arrangement exists, (ii) delivery (or passage of title) has occurred or services have been rendered, (iii) the seller’s price to the buyer is fixed or determinable, and (iv) collectability is reasonably assured. We also comply with the authoritative guidance for revenue recognition regarding arrangements with multiple deliverables. | |||
Contract Manufacturing Revenue | |||
Revenue associated with contract manufacturing services provided by Avid is recognized once the service has been rendered and/or upon shipment (or passage of title) of the product to the customer. On occasion, we recognize revenue on a “bill-and-hold” basis in accordance with the authoritative guidance. Under “bill-and-hold” arrangements, revenue is recognized once the product is complete and ready for shipment, title and risk of loss has passed to the customer, management receives a written request from the customer for “bill-and-hold” treatment, the product is segregated from other inventory, and no further performance obligations exist. | |||
In addition, we also follow the authoritative guidance when reporting revenue as gross when we act as a principal versus reporting revenue as net when we act as an agent. For transactions in which we act as a principal, have discretion to choose suppliers, bear credit and inventory risk and perform a substantive part of the services, revenue is recorded at the gross amount billed to a customer and costs associated with these reimbursements are reflected as a component of cost of sales for contract manufacturing services. | |||
Any amounts received prior to satisfying our revenue recognition criteria are recorded as deferred revenue in the accompanying interim unaudited condensed consolidated financial statements. We also record a provision for estimated contract losses, if any, in the period in which they are determined | |||
License Revenue | |||
Revenue associated with licensing agreements primarily consists of non-refundable upfront license fees, non-refundable annual license fees and milestone payments. Non-refundable upfront license fees received under license agreements, whereby continued performance or future obligations are considered inconsequential to the relevant license technology, are recognized as revenue upon delivery of the technology. If a licensing agreement has multiple elements, we analyze each element of our licensing agreements and consider a variety of factors in determining the appropriate method of revenue recognition of each element. | |||
Multiple Element Arrangements. Prior to the adoption of ASU No. 2009-13 on May 1, 2011, if a license agreement has multiple element arrangements, we analyze and determine whether the deliverables, which often include performance obligations, can be separated or whether they must be accounted for as a single unit of accounting in accordance with the authoritative guidance. Under multiple element arrangements, we recognize revenue for delivered elements only when the delivered element has stand-alone value and we have objective and reliable evidence of fair value for each undelivered element. If the fair value of any undelivered element included in a multiple element arrangement cannot be objectively determined, the arrangement would then be accounted for as a single unit of accounting, and revenue is recognized over the estimated period of when the performance obligation(s) are performed. | |||
In addition, under certain circumstances, when there is objective and reliable evidence of the fair value of the undelivered items in an arrangement, but no such evidence for the delivered items, we utilize the residual method to allocate the consideration received under the arrangement. Under the residual method, the amount of consideration allocated to delivered items equals the total arrangement consideration less the aggregate fair value of the undelivered items, and revenue is recognized upon delivery of the undelivered items based on the relative fair value of the undelivered items. | |||
For new licensing agreements or material modifications of existing licensing agreements entered into after May 1, 2011, we follow the provisions of ASU No. 2009-13. If a licensing agreement includes multiple elements, we identify which deliverables represent separate units of accounting, and then determine how the arrangement consideration should be allocated among the separate units of accounting, which may require the use of significant judgment. | |||
If a licensing agreement includes multiple elements, a delivered item is considered a separate unit of accounting if both of the following criteria are met: | |||
1 | The delivered item has value to the licensing partner on a standalone basis based on the consideration of the relevant facts and circumstances for each agreement; | ||
2 | If the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in the Company’s control. | ||
Arrangement consideration is allocated at the inception of the agreement to all identified units of accounting based on their relative selling price. The relative selling price for each deliverable is determined using vendor specific objective evidence (“VSOE”) of selling price or third-party evidence of selling price if VSOE does not exist. If neither VSOE nor third-party evidence of selling price exists, we use our best estimate of the selling price for the deliverable. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. Changes in the allocation of the sales price between delivered and undelivered elements can impact revenue recognition but do not change the total revenue recognized under any agreement. | |||
Milestone Payments. Effective May 1, 2011, we adopted on a prospective basis the Milestone Method under ASU No. 2010-17 for new licensing agreements or material modifications of existing licensing agreements entered into after May 1, 2011. Under the Milestone Method, we recognize consideration that is contingent upon the achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone is substantive in its entirety. A milestone is considered substantive when it meets all of the following criteria: | |||
1 | The consideration is commensurate with either the entity’s performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone; | ||
2 | The consideration relates solely to past performance; and | ||
3 | The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. | ||
A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity’s performance or on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to the Company. | |||
The provisions of ASU No. 2010-17 do not apply to contingent consideration for which payment is either contingent solely upon the passage of time or the result of a counterparty’s performance. We will assess the nature of, and appropriate accounting for, these payments on a case-by-case basis in accordance with the applicable authoritative guidance for revenue recognition. | |||
Any amounts received prior to satisfying our revenue recognition criteria are recorded as deferred revenue in the accompanying interim unaudited condensed consolidated financial statements. | |||
Fair Value Measurements | |||
We determine fair value measurements in accordance with the authoritative guidance for fair value measurements and disclosures for all assets and liabilities within the scope of this guidance. This guidance, which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The guidance prioritizes the inputs used in measuring fair value into the following hierarchy: | |||
· | Level 1 – Quoted prices in active markets for identical assets or liabilities. | ||
· | Level 2 – Observable inputs other than quoted prices included in Level 1, such as assets or liabilities whose values are based on quoted market prices in markets where trading occurs infrequently or whose values are based on quoted prices of instruments with similar attributes in active markets. | ||
· | Level 3 – Unobservable inputs that are supported by little or no market activity and significant to the overall fair value measurement. | ||
As of January 31, 2014 and April 30, 2013, we do not have any Level 2 or Level 3 financial assets or liabilities and our cash and cash equivalents are carried at fair value based on quoted market prices for identical securities (Level 1 input). | |||
Customer Deposits | |||
Customer deposits primarily represent advance billings and/or payments received from Avid’s third-party customers prior to the initiation of contract manufacturing services. | |||
Research and Development Expenses | |||
Research and development costs are charged to expense when incurred in accordance with the authoritative guidance for research and development costs. Research and development expenses primarily include (i) payroll and related costs associated with research and development personnel, (ii) share-based compensation expense associated with share-based awards granted to research and development personnel, (iii) costs related to clinical and preclinical testing of our technologies under development, (iv) costs to develop and manufacture the product candidates, including raw materials and supplies, product testing, depreciation, and facility related expenses, (v) expenses for research services provided by universities and contract laboratories, including sponsored research funding, and (v) other research and development expenses. | |||
Accrued Clinical Trial and Related Fees | |||
We accrue clinical trial and related fees based on work performed in connection with advancing our clinical trials, which relies on estimates and/or representations from clinical research organizations (“CROs”), hospitals, consultants and other clinical trial related vendors. We maintain regular communication with our vendors, including our CROs, and gauge the reasonableness of estimates provided. However, actual clinical trial costs may differ from estimated clinical trial costs and are adjusted for in the period in which they become known. There were no material adjustments for a change in estimate to research and development expenses in the accompanying interim unaudited condensed consolidated financial statements for the three and nine months ended January 31, 2014 and 2013. | |||
Share-based Compensation | |||
We account for stock options and other share-based awards granted under our equity compensation plans in accordance with the authoritative guidance for share-based compensation. The estimated fair value of share-based payments to employees in exchange for services is measured at the grant date, using a fair value based method, and is recognized as expense on a straight-line basis over the requisite service periods. Share-based compensation expense recognized during the period is based on the value of the portion of the share-based payment that is ultimately expected to vest during the period. | |||
In addition, we periodically grant stock options and other share-based awards to non-employee consultants, which we account for in accordance with the authoritative guidance for share-based compensation. The cost of non-employee services received in exchange for share-based awards are measured based on either the fair value of the consideration received or the fair value of the share-based award issued, whichever is more reliably measurable. In addition, guidance requires share-based compensation related to unvested options and awards issued to non-employees to be recalculated at the end of each reporting period based upon the fair market value on that date until the share-based award has vested, and any adjustment to share-based compensation resulting from the re-measurement is recognized in the current period. See Note 8 for further discussion regarding share-based compensation. | |||
Basic and Dilutive Net Loss Per Common Share | |||
Basic net loss per common share is computed by dividing our net loss by the weighted average number of common shares outstanding during the period excluding the dilutive effects of stock options, common shares expected to be issued under our employee stock purchase plan, and warrants in accordance with the authoritative guidance. Diluted net loss per common share is computed by dividing the net loss by the sum of the weighted average number of common shares outstanding during the period plus the potential dilutive effects of stock options, common shares expected to be issued under our employee stock purchase plan, and warrants outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. Because the impact of options, common shares expected to be issued under our employee stock purchase plan, and warrants are anti-dilutive during periods of net loss, there was no difference between basic and diluted loss per share amounts for the three and nine months ended January 31, 2014 and 2013. | |||
The calculation of weighted average diluted shares outstanding excludes the dilutive effect of outstanding stock options, common shares expected to be issued under our employee stock purchase plan, and warrants, to purchase up to an aggregate of 3,800,577 and 3,984,472 shares of common stock for the three and nine months ended January 31, 2014, respectively, 3,387,483 and 3,500,609 shares of common stock for the three and nine months ended January 31, 2013, respectively, since their impact are anti-dilutive during periods of net loss. | |||
The calculation of weighted average diluted shares outstanding also excludes weighted average outstanding stock options and warrants to purchase up to an aggregate of 5,547,131 and 5,865,858 shares of common stock for the three and nine months ended January 31, 2014, respectively, and 6,053,421 and 6,044,158 shares of common stock for the three and nine months ended January 31, 2013, respectively, as their exercise prices were greater than the average market price of our common stock during the respective periods, resulting in an anti-dilutive effect. |
3_TRADE_AND_OTHER_RECEIVABLES
3. TRADE AND OTHER RECEIVABLES | 9 Months Ended | ||||||||
Jan. 31, 2014 | |||||||||
Receivables [Abstract] | ' | ||||||||
3. TRADE AND OTHER RECEIVABLES | ' | ||||||||
Trade and other receivables, net, consists of the following at January 31, 2014 and April 30, 2013: | |||||||||
January 31, | April 30, | ||||||||
2014 | 2013 | ||||||||
Trade receivables(1) | $ | 2,769,000 | $ | 1,642,000 | |||||
Other receivables, net | 13,000 | 20,000 | |||||||
Trade and other receivables, net | $ | 2,782,000 | $ | 1,662,000 | |||||
______________ | |||||||||
-1 | Represents amounts billed for contract manufacturing services provided by Avid. | ||||||||
We continually monitor our allowance for doubtful accounts for all receivables. We apply judgment in assessing the ultimate realization of our receivables and we estimate an allowance for doubtful accounts based on various factors, such as, the aging of accounts receivable balances, historical experience, and the financial condition of our customers. Based on our analysis of our receivables as of January 31, 2014 and April 30, 2013, we determined an allowance for doubtful accounts of $13,000 and $16,000, respectively, was necessary with respect to our other receivables, and no allowance was necessary with respect to our trade receivables. |
4_PROPERTY_AND_EQUIPMENT
4. PROPERTY AND EQUIPMENT | 9 Months Ended | ||||||||
Jan. 31, 2014 | |||||||||
Property, Plant and Equipment [Abstract] | ' | ||||||||
4. PROPERTY AND EQUIPMENT | ' | ||||||||
Property and equipment, net, consists of the following at January 31, 2014 and April 30, 2013: | |||||||||
January 31, | April 30, | ||||||||
2014 | 2013 | ||||||||
Leasehold improvements | $ | 1,522,000 | $ | 1,383,000 | |||||
Laboratory equipment | 5,558,000 | 5,441,000 | |||||||
Furniture, fixtures, office equipment and software | 2,601,000 | 2,627,000 | |||||||
9,681,000 | 9,451,000 | ||||||||
Less accumulated depreciation and amortization | (7,167,000 | ) | (6,773,000 | ) | |||||
Property and equipment, net | $ | 2,514,000 | $ | 2,678,000 | |||||
Depreciation and amortization expense for three and nine months ended January 31, 2014 was $244,000 and $737,000, respectively, and $280,000 and $806,000 for the three and nine months ended January 31, 2013, respectively. |
5_INVENTORIES
5. INVENTORIES | 9 Months Ended | ||||||||
Jan. 31, 2014 | |||||||||
Inventory Disclosure [Abstract] | ' | ||||||||
5. INVENTORIES | ' | ||||||||
Inventories are stated at the lower of cost or market and primarily include raw materials, direct labor and overhead costs (work-in-process) associated with our wholly-owned subsidiary, Avid. Cost is determined by the first-in, first-out method. Inventories consist of the following at January 31, 2014 and April 30, 2013: | |||||||||
January 31, | April 30, | ||||||||
2014 | 2013 | ||||||||
Raw materials | $ | 2,303,000 | $ | 2,169,000 | |||||
Work-in-process | 2,921,000 | 2,170,000 | |||||||
Total inventories | $ | 5,224,000 | $ | 4,339,000 |
6_NOTE_PAYABLE
6. NOTE PAYABLE | 9 Months Ended |
Jan. 31, 2014 | |
Debt Disclosure [Abstract] | ' |
6. NOTE PAYABLE | ' |
On August 30, 2012, we entered into a loan and security agreement (the “Loan Agreement”) with Oxford Finance LLC, MidCap Financial SBIC LP, and Silicon Valley Bank (collectively, the “Lenders”) for up to $30,000,000 in total funding available in two $15,000,000 tranches. The Loan Agreement was secured by a first-priority security interest in substantially all of our assets, excluding our intellectual property and our rights under license agreements granting us rights to intellectual property. On August 30, 2012, we received initial funding of $15,000,000 under the Loan Agreement, excluding debt issuance costs of $251,000. | |
On September 24, 2012, we received a written notice of default (“Notice of Default”) from the Lenders, with respect to the Loan Agreement. The Notice of Default was triggered by a material adverse change under the Loan Agreement due to our discovery of major discrepancies in treatment group coding by an independent third-party vendor responsible for distribution of blinded investigational product used in our bavituximab Phase IIb second-line non-small cell lung cancer (“NSCLC”) clinical trial. Pursuant to the terms of the Notice of Default, all amounts due under the Loan Agreement were declared immediately due and payable by the Lenders. On September 25, 2012, we paid the Lenders all obligations declared due and payable under the Loan Agreement, including outstanding principal of $15,000,000, accrued interest thereon at the Loan Agreement’s applicable fixed rate of 7.95% per annum, plus a final payment fee equal to 6.5% of the principal amount funded (or $975,000), upon which, the Loan Agreement was terminated. | |
In addition, under the Loan Agreement, we agreed to issue to the Lenders six-year warrants to purchase shares of our common stock upon the funding of each tranche in an amount equal to 4.50% of the amount of such tranche divided by the exercise price as defined in the Loan Agreement. Upon the initial funding under the Loan Agreement, we issued the Lenders warrants to purchase an aggregate of 273,280 shares of our common stock at a per share price of $2.47, which are exercisable on a cash or cashless basis, and will expire on August 30, 2018. The fair value of the warrants issued was $470,000 and was calculated using a Black-Scholes valuation model with the following assumptions: risk-free interest rate of 0.87%; expected volatility of 80.20%; expected term of six years; and a dividend yield of 0%. The fair value of the warrants issued was initially recorded as a debt discount with a corresponding increase to additional paid-in capital. As of January 31, 2014, the warrants issued under the Loan Agreement were outstanding and exercisable (Note 9). | |
Upon the termination of the Loan Agreement, we recorded a loss on the early extinguishment of debt of $1,696,000, which consisted of the final payment fee of $975,000, the unamortized debt discount associated with the fair value of the warrants issued to the Lenders of $470,000, and the unamortized aggregate debt issuance costs of $251,000. The loss on the early extinguishment of debt is included in the accompanying interim unaudited condensed consolidated statements of operations and comprehensive loss for the nine months ended January 31, 2013. |
7_STOCKHOLDERS_EQUITY
7. STOCKHOLDERS' EQUITY | 9 Months Ended | ||||
Jan. 31, 2014 | |||||
Equity [Abstract] | ' | ||||
7. STOCKHOLDERS' EQUITY | ' | ||||
Sales of Common Stock | |||||
Our ability to continue our clinical trials and development efforts is highly dependent on the amount of cash and cash equivalents on hand combined with our ability to raise additional capital to support our future operations through one or more methods, including but not limited to, issuing additional equity. | |||||
With respect to financing our operations through the issuance of equity, on December 27, 2012, we entered into an At Market Sales Issuance Agreement (“December 2012 AMI Agreement”) with MLV & Co. LLC (“MLV”), pursuant to which we may sell shares of our common stock through MLV, as agent, for aggregate gross proceeds of up to $75,000,000, in registered transactions from our shelf registration statement on Form S-3 (File No. 333-180028), which became effective on April 12, 2012. During the nine months ended January 31, 2014, we sold 31,983,986 shares of common stock at market prices under the December 2012 AMI Agreement for aggregate gross proceeds of $52,407,000 before deducting commissions and other issuance costs of $1,427,000. As of January 31, 2014, aggregate gross proceeds of up to $9,221,000 remained available under the December 2012 AMI Agreement. | |||||
In addition, on December 27, 2013, we filed a shelf registration statement on Form S-3, File number 333-193113 (“December 2013 Shelf”), which became effective on January 16, 2014, under which we may issue, from time to time, in one or more offerings, offer and sale either individually or in combination, shares of our common stock or preferred stock for gross proceeds not to exceed $100,000,000. As of January 31, 2014, we had not issued any shares of our common or preferred stock under the December 2013 Shelf. | |||||
Shares of Common Stock Authorized and Reserved for Future Issuance | |||||
As of January 31, 2014, we had reserved 29,584,997 additional shares of our common stock, which may be issued under our equity compensation plans and outstanding warrant agreements, excluding shares of common stock that could potentially be issued under our current effective shelf registration statements, as further described in the following table: | |||||
Number of Shares | |||||
Reserved | |||||
Common shares reserved for issuance under outstanding option grants and common shares available for issuance under our stock incentive plans | 26,134,940 | ||||
Common shares reserved for and available for issuance under our Employee Stock Purchase Plan | 3,176,777 | ||||
Common shares issuable upon exercise of outstanding warrants | 273,280 | ||||
Total shares of common stock reserved for issuance | 29,584,997 |
8_EQUITY_COMPENSATION_PLANS
8. EQUITY COMPENSATION PLANS | 9 Months Ended | ||||||||||||||||
Jan. 31, 2014 | |||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | ||||||||||||||||
8. EQUITY COMPENSATION PLANS | ' | ||||||||||||||||
Stock Incentive Plans | |||||||||||||||||
On October 17, 2013, our stockholders approved an amendment to our 2011 Stock Incentive Plan (the “2011 Plan”) to increase the number of shares of our common stock reserved for issuance under the 2011 Plan from 11,500,000 shares to up to 18,500,000 shares. | |||||||||||||||||
As of January 31, 2014, we had an aggregate of 26,134,940 shares of our common stock reserved for issuance under our stock incentive plans, of which, 18,226,657 shares were subject to outstanding options and 7,908,283 shares were available for future grants of share-based awards. | |||||||||||||||||
The following summarizes our stock option transaction activity for the nine months ended January 31, 2014: | |||||||||||||||||
Stock Options | Shares | Weighted Average | |||||||||||||||
Exercisable Price | |||||||||||||||||
Outstanding, May 1, 2013 | 15,287,208 | $1.84 | |||||||||||||||
Granted | 4,615,060 | $1.41 | |||||||||||||||
Exercised | (338,547 | ) | $0.74 | ||||||||||||||
Canceled or expired | (1,337,064 | ) | $4.35 | ||||||||||||||
Outstanding, January 31, 2014 | 18,226,657 | $1.57 | |||||||||||||||
The following summarizes our restricted stock award transaction activity for the nine months ended January 31, 2014: | |||||||||||||||||
Restricted Stock | Shares | Weighted | |||||||||||||||
Average | |||||||||||||||||
Grant Date | |||||||||||||||||
Fair Value | |||||||||||||||||
Unvested, May 1, 2013 | – | $ - | |||||||||||||||
Granted | 100,000 | $1.39 | |||||||||||||||
Vested | (100,000 | ) | $1.39 | ||||||||||||||
Canceled or expired | – | $ - | |||||||||||||||
Unvested, January 31, 2014 | – | $ - | |||||||||||||||
Employee Stock Purchase Plan | |||||||||||||||||
We have reserved a total of 5,000,000 shares of common stock to be purchased under our 2010 Employee Stock Purchase Plan (the “2010 ESPP”), of which 3,176,777 shares of common stock remain available for purchase as of January 31, 2014. Under the 2010 ESPP, we will sell shares to participants at a price equal to the lesser of 85% of the fair market value of stock at the (i) beginning of a six-month offering period or (ii) at the end of the six-month offering period. The 2010 ESPP provides for two six-month offering periods each year; the first offering period will begin on the first trading day on or after each November 1; the second offering period will begin on the first trading day on or after each May 1. During the nine months ended January 31, 2014, 261,782 shares of our common stock were purchased under the 2010 ESPP at a purchase price per share of $1.08. | |||||||||||||||||
Share-Based Compensation | |||||||||||||||||
Total share-based compensation expense for the three and nine-month periods ended January 31, 2014 and 2013 are included in the accompanying interim unaudited condensed consolidated statements of operations and comprehensive loss as follows: | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
January 31, | January 31, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Cost of contract manufacturing | $ | 18,000 | $ | 37,000 | $ | 58,000 | $ | 55,000 | |||||||||
Research and development | 769,000 | 539,000 | 2,231,000 | 1,151,000 | |||||||||||||
Selling, general and administrative | 814,000 | 453,000 | 2,625,000 | 1,114,000 | |||||||||||||
Total | $ | 1,601,000 | $ | 1,029,000 | $ | 4,914,000 | $ | 2,320,000 | |||||||||
Share-based compensation from: | |||||||||||||||||
Stock options | $ | 1,540,000 | $ | 870,000 | $ | 4,549,000 | $ | 2,069,000 | |||||||||
Restricted stock awards | – | – | 139,000 | – | |||||||||||||
Employee stock purchase plan | 61,000 | 159,000 | 226,000 | 251,000 | |||||||||||||
$ | 1,601,000 | $ | 1,029,000 | $ | 4,914,000 | $ | 2,320,000 | ||||||||||
As of January 31, 2014, the total estimated unrecognized compensation cost related to non-vested stock options was $5,452,000. This cost is expected to be recognized over a weighted average vesting period of 1.18 years based on current assumptions. |
9_WARRANTS
9. WARRANTS | 9 Months Ended |
Jan. 31, 2014 | |
Warrants and Rights Note Disclosure [Abstract] | ' |
9. WARRANTS | ' |
No warrants were granted or exercised during the three and nine months ended January 31, 2014. In addition, warrants to purchase 101,523 shares of common stock expired unexercised during the three and nine months ended January 31, 2014. As of January 31, 2014, warrants to purchase 273,280 shares of our common stock at an exercise price of $2.47 were outstanding and are exercisable through August 30, 2018 (Note 6). |
10_SEGMENT_REPORTING
10. SEGMENT REPORTING | 9 Months Ended | ||||||||||||||||
Jan. 31, 2014 | |||||||||||||||||
Segment Reporting [Abstract] | ' | ||||||||||||||||
10. SEGMENT REPORTING | ' | ||||||||||||||||
Our business is organized into two reportable operating segments and both operate in the U.S. Peregrine is engaged in the research and development of monoclonal antibodies for the treatment and diagnosis of cancer. Avid is engaged in providing contract manufacturing services for Peregrine and third-party customers on a fee-for-service basis. | |||||||||||||||||
The accounting policies of the operating segments are the same as those described in Note 2. We evaluate the performance of our contract manufacturing services segment based on gross profit or loss from third-party customers. However, our products in the research and development segment are not evaluated based on gross profit or loss, but rather based on scientific progress of the technologies. As such, gross profit or loss is only provided for our contract manufacturing services segment in the below table. All revenues shown below are derived from transactions with third-party customers. | |||||||||||||||||
Segment information for the three and nine-month periods is summarized as follows: | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
January 31, | January 31, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Contract manufacturing services revenue | $ | 3,885,000 | $ | 6,961,000 | $ | 15,820,000 | $ | 17,157,000 | |||||||||
Cost of contract manufacturing services | 2,416,000 | 3,651,000 | 9,281,000 | 9,378,000 | |||||||||||||
Gross profit | 1,469,000 | 3,310,000 | 6,539,000 | 7,779,000 | |||||||||||||
Revenue from products in research and development | – | 78,000 | 107,000 | 272,000 | |||||||||||||
Research and development expense | (6,649,000 | ) | (5,437,000 | ) | (18,910,000 | ) | (18,471,000 | ) | |||||||||
Selling, general and administrative expense | (4,563,000 | ) | (3,112,000 | ) | (12,913,000 | ) | (9,469,000 | ) | |||||||||
Other income, net | 19,000 | 247,000 | 63,000 | 254,000 | |||||||||||||
Loss on early extinguishment of debt | – | – | – | (1,696,000 | ) | ||||||||||||
Net loss | $ | (9,724,000 | ) | $ | (4,914,000 | ) | $ | (25,114,000 | ) | $ | (21,331,000 | ) | |||||
Revenue generated from our contract manufacturing services segment was derived from a limited number of customers. The percentages below represent revenue derived from each customer as a percentage of total contract manufacturing services revenue: | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
January 31, | January 31, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
United States (customer A) | 87 | % | 60 | % | 88 | % | 78 | % | |||||||||
United States (customer B) | 13 | 2 | 9 | 1 | |||||||||||||
United States (customer C) | – | 37 | 2 | 20 | |||||||||||||
Other customers | – | 1 | 1 | 1 | |||||||||||||
Total | 100% | 100 | % | 100 | % | 100 | % | ||||||||||
Revenue generated from our products in our research and development segment during the three and nine months ended January 31, 2014 and 2013 is directly related to license revenue recognized under licensing agreements with an unrelated entity. | |||||||||||||||||
11_COMMITMENTS_AND_CONTINGENCI
11. COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Jan. 31, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ' |
11. COMMITMENTS AND CONTINGENCIES | ' |
In the ordinary course of business, we are at times subject to various legal proceedings and disputes. Except as set forth below, we currently are not aware of any material litigation or other dispute nor, to management’s knowledge, is any litigation or other proceeding threatened against us that collectively is expected to have a material adverse effect on our consolidated cash flows, financial condition or results of operations. | |
Securities Class Action Lawsuit | |
On September 28, 2012, three complaints were filed in the U.S. District Court for the Central District of California against us and certain of our executive officers and one consultant (collectively, the “Defendants”) on behalf of certain purchasers of our common stock. The complaints have been brought as purported stockholder class actions, and, in general, include allegations that Defendants violated (i) Section 10(b) of the Exchange Act, and Rule 10b-5 promulgated thereunder and (ii) Section 20(a) of the Exchange Act, by making materially false and misleading statements regarding the interim results of our bavituximab Phase II second-line NSCLC trial, thereby artificially inflating the price of our common stock. The plaintiffs are seeking unspecified monetary damages and other relief. On November 27, 2012, four prospective lead plaintiffs filed motions to consolidate, appoint a lead plaintiff and appoint lead counsel. On February 5, 2013, the court consolidated the related actions with the low-numbered case (captioned Anderson v. Peregrine Pharmaceuticals, Inc., et al., Case No. 12-cv-1647-PSG (FMOx)), appointed James T. Fahey as lead plaintiff, and appointed Mr. Fahey’s counsel as lead counsel. The lead plaintiff filed an amended consolidated complaint on April 15, 2013. On June 14, 2013, Defendants moved to dismiss the amended consolidated complaint. On July 15, 2013, lead plaintiff filed an opposition to Defendants’ motion to dismiss and separately moved to strike certain exhibits attached to Defendants’ motion. On August 19, 2013 the court held a hearing on Defendants’ motion to dismiss and on lead plaintiff’s motion to strike. On August 23, 2013, the court issued its order granting Defendants’ motion to dismiss and denying lead plaintiff’s motion to strike. In its order, the court gave lead plaintiff leave to amend his complaint on or before September 16, 2013. On September 16, 2013 lead plaintiff filed his first amended complaint. On October 3, 2013, Defendants’ filed a motion to dismiss the first amended complaint. Briefing on that motion concluded in early November 2013 and, on November 22, 2013, the court issued an order granting Defendants’ motion to dismiss the first amended complaint. The court again granted lead plaintiff leave to file a second amended complaint, which lead plaintiff did on January 22, 2014. On February 24, 2014, Defendants’ filed a motion to dismiss the second amended complaint. The court’s hearing on the Defendant’s motion to dismiss the second amended complaint is scheduled for May 5, 2014. We believe that the class action lawsuit is without merit and intend to vigorously defend the action, including seeking dismissal of any amended complaint. Due to the early stage of the proceeding, we believe that the probability of an unfavorable outcome or loss related to the proceeding and an estimate of the amount or range of loss related to the claims, if any, from an unfavorable outcome is not determinable at this time. | |
Derivative Litigation | |
On May 9, 2013, an alleged shareholder filed, purportedly on behalf of the Company, a derivative lawsuit, captioned Roy v. Steven W. King, et al., Case No. 13-cv-0741-PSG (RNBx), in the U.S. District Court for the Central District of California against certain of our executive officers and directors. The complaint asserts claims for breach of fiduciary duty, abuse of control, gross mismanagement, waste of corporate assets and unjust enrichment arising from substantially similar factual allegations as those asserted in the consolidated securities class action lawsuit, described above (the “Securities Class Action”). This case was subsequently transferred to the same court and judge handling the Securities Class Action lawsuit. On May 31, 2013, the judge issued an order staying this derivative litigation pending the final resolution of defendants’ motions to dismiss in the Securities Class Action. | |
On October 10, 2013, a derivative and class action complaint, captioned Michaeli v. Steven W. King, et al., C.A. No. 8994-VCL, was filed in the Court of Chancery of the State of Delaware against certain of our executive officers and directors. The complaint alleges that the Company’s directors and executives breached their respective fiduciary duties in connection with certain purportedly improper compensation decisions made by the Company’s Board of Directors during the past three fiscal years, including: (i) the grant of a stock option to Mr. King on May 4, 2012; (ii) the non-routine broad-based stock option grant to the Company’s directors, executives, all other employees and certain consultants on December 27, 2012; and (iii) the payment, during the past three fiscal years, of compensation to the Company’s non-employee directors. In addition, the complaint alleges that the Company’s directors breached their fiduciary duty of candor by filing and seeking stockholder action on the basis of an allegedly materially false and misleading proxy statement for the Company’s 2013 annual meeting of stockholders. The defendants filed their answer to the complaint on February 5, 2014. This matter is in the early stages of discovery, and therefore, we believe that the probability of an unfavorable outcome or loss related to the proceeding and an estimate of the amount or range of loss related to the claims, if any, from an unfavorable outcome is not determinable at this time. | |
Other Legal Matters | |
On September 24, 2012, we filed a lawsuit, captioned Peregrine Pharmaceuticals, Inc. v. Clinical Supplies Management, Inc., Case No. 8:12-cv-01608 JST(AN) (C.D. Cal), against Clinical Supplies Management, Inc. (“CSM”), in the U.S. District Court for the Central District of California. In 2010, we had contracted with CSM as our third-party vendor responsible for distribution of the blinded investigational product used in our bavituximab Phase IIb second-line NSCLC trial. As part of the routine collection of data in advance of an end-of-Phase II meeting with regulatory authorities, we discovered major discrepancies between some patient sample test results and patient treatment code assignments. Consequently, we filed this lawsuit against CSM alleging breach of contract, negligence and negligence per se arising from CSM’s performance of its contracted services. We are seeking monetary damages. On March 7, 2013, we and CSM submitted to the court a proposed stipulation pursuant to which the lawsuit would be stayed for up to 120 days during which time we and CSM would participate in an alternative dispute resolution process, pursuant to our contract with CSM. The proposed stipulation was approved by the court on March 8, 2013. On June 26, 2013, we and CSM engaged in an alternative dispute resolution session that did not result in any resolution of our dispute. The aforementioned stay expired on July 6, 2013. We granted CSM until July 19, 2013 to file an answer to our complaint, which CSM did on July 11, 2013. The parties appeared in court February 2014 for a scheduling conference at which the court scheduled the trial to commence in April 2015. | |
12_SUBSEQUENT_EVENTS
12. SUBSEQUENT EVENTS | 9 Months Ended |
Jan. 31, 2014 | |
Subsequent Events [Abstract] | ' |
12. SUBSEQUENT EVENTS | ' |
On February 11, 2014, we entered into an underwriting agreement (the “Underwriting Agreement”) with MLV & Co. LLC (“MLV”), as representative for the underwriters identified therein (collectively, the “Underwriters”), providing for the offer and sale to the Underwriters in a firm commitment underwritten public offering of 700,000 shares (the “Firm Shares”) of the Company’s newly designated 10.50% Series E Convertible Preferred Stock, par value $0.001 per share (the “Series E Preferred Stock”), at a public offering price of $25.00 per share (the “Offering”). In addition, pursuant to the Underwriting Agreement, we also granted the Underwriters a 30-day option to purchase up to an additional 105,000 shares of our Series E Preferred Stock under this Offering at the public offering price less the underwriting discount to cover over-allotments, if any (“Overallotment Option”). | |
We completed the sale of the Firm Shares on February 19, 2014 for aggregate gross proceeds of $17,500,000, before deducting underwriting discounts and commissions and other offering expenses payable by us. In addition, on February 27, 2014, the Underwriters purchased an additional 75,000 shares of our Series E Preferred Stock upon partial exercise of the Overallotment Option at the public offering price of $25.00 per share for aggregate gross proceeds of $1,875,000, before deducting underwriting discounts and commissions and other offering related expenses payable by us. The aggregate net proceeds received from the Offering, including the partial exercise of the Overallotment Option, were approximately $17.9 million, after deducting underwriting discounts and commissions and other offering related expenses. | |
The Offering was made pursuant to a prospectus supplement filed with the SEC on February 12, 2014 to our registration statement on Form S-3 (File No. 333-193113) (Note 7). | |
On February 12, 2014, we filed with the Secretary of State of the State of Delaware a Certificate of Designations of Rights and Preferences (the “Certificate of Designations”) to designate the Series E Preferred Stock. The Certificate of Designations designates 2,000,000 shares of Series E Preferred Stock to be created out of our 5,000,000 shares of authorized but unissued shares of preferred stock. The rights and preferences of the Series E Preferred Stock include: | |
(i) The holders are entitled to receive a 10.50% per annum cumulative quarterly dividend, payable in cash, on or about the 1st day of each of January, April, July, and October; | |
(ii) The dividend may increase to a penalty rate of 12.50% if: (a) we fail to pay dividends for any four consecutive or nonconsecutive quarterly dividend periods, or (b) once the Series E Preferred Stock becomes initially eligible for listing on a national securities exchange, we fail, for 180 or more consecutive days, to maintain such listing; | |
(iii) Following a change of control of the Company (as defined in the Certificate of Designations) by a person or entity, we (or the acquiring entity) may, at our option, redeem the Series E Preferred Stock, in whole but not in part, within 120 days after the date on which the change of control has occurred for cash, at the redemption price; | |
(iv) We may not redeem the Series E Preferred Stock prior to February 11, 2017 (except following a change of control) and, on and after February 11, 2017, we may redeem the Series E Preferred Stock for cash at our option, from time to time, in whole or in part, at the redemption price; | |
(v) The redemption price is $25.00 per share, plus any accrued and unpaid dividends (whether or not earned or declared) to, but excluding, the redemption date; | |
(vi) The liquidation preference is $25.00 per share, plus any accrued and unpaid dividends (whether or not earned or declared); | |
(vii) The Series E Preferred Stock has no stated maturity date or mandatory redemption and is senior to all of the Company’s other securities; | |
(viii) There is a general conversion right with respect to the Series E Preferred Stock with an initial conversion price of $3.00, a special conversion right upon a change of control, and a market trigger conversion at our option in the event of Market Trigger (as defined in the Certificate of Designations); and | |
(ix) The holders of the Series E Preferred Stock have no voting rights, except as defined in the Certificate of Designations. | |
The foregoing description does not purport to be complete and is qualified in its entirety by reference to the Certificate of Designations which was filed as Exhibit 3.11 to the Company’s Form 8-A filed with the SEC on February 12, 2014 and is incorporated herein by reference. |
2_SUMMARY_OF_SIGNIFICANT_ACCOU1
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended | ||
Jan. 31, 2014 | |||
Accounting Policies [Abstract] | ' | ||
Basis of Presentation | ' | ||
The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) related to quarterly reports on Form 10-Q. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for a complete set of financial statements. These interim unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended April 30, 2013. The condensed consolidated balance sheet at April 30, 2013, has been derived from audited financial statements at that date. The unaudited financial information for the interim periods presented herein reflects all adjustments which, in the opinion of management, are necessary for a fair presentation of the financial condition and results of operations for the periods presented, with such adjustments consisting only of normal recurring adjustments. Results of operations for interim periods covered by this quarterly report on Form 10-Q may not necessarily be indicative of results of operations for the full fiscal year. | |||
The interim unaudited condensed consolidated financial statements include the accounts of Peregrine and Avid. All intercompany accounts and transactions have been eliminated in the interim unaudited condensed consolidated financial statements. | |||
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts, as well as disclosures of commitments and contingencies in the financial statements and accompanying notes. Actual results could differ from those estimates. | |||
Adoption of Recent Accounting Pronouncements | ' | ||
Effective May 1, 2013, we adopted Financial Accounting Standards Board’s (“FASB”) Accounting Standards Update (“ASU”) No. 2013-02, Other Comprehensive Income (Topic 220): Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income. ASU No. 2013-02 does not change the current requirements for reporting net income or other comprehensive income in financial statements, however, it does require an entity to report the effect of significant reclassifications out of accumulated other comprehensive income on the respective line items in net income if the amounts are required to be reclassified in their entirety to net income. For other amounts that are not required to be reclassified in their entirety to net income in the same reporting period, an entity is required to cross-reference to other disclosures that provide additional detail about those amounts. The adoption ASU No. 2013-02 did not have a material impact on our consolidated financial statements. | |||
Pending Adoption of Recent Accounting Pronouncements | ' | ||
In July 2013, the FASB issued ASU No. 2013-11, Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists. ASU No. 2013-11 requires entities to present in the financial statements an unrecognized tax benefit, or a portion of an unrecognized tax benefit as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward except to the extent such items are not available or not intended to be used at the reporting date to settle any additional income taxes that would result from the disallowance of a tax position. In such instances, the unrecognized tax benefit is required to be presented in the financial statements as a liability and not be combined with deferred tax assets. This guidance is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013, which will be our fiscal year 2015 (or May 1, 2014). We do not expect the adoption of this guidance to have a material impact on our consolidated financial statements. | |||
Liquidity and Financial Condition | ' | ||
At January 31, 2014, we had $63,177,000 in cash and cash equivalents. We have expended substantial funds on the research and development of our product candidates, and funding the operations of Avid. As a result, we have historically experienced negative cash flows from operations since our inception and we expect negative cash flows from operations to continue in the foreseeable future. Our net loss incurred during the nine-month period ended January 31, 2014 amounted to $25,114,000 and our net losses incurred during the past three fiscal years ended April 30, 2013, 2012 and 2011, amounted to $29,780,000, $42,119,000, and $34,151,000, respectively. Therefore, unless and until we are able to generate sufficient revenues from Avid’s contract manufacturing services and/or from the sale and/or licensing of our products under development, we expect such losses to continue in the foreseeable future. | |||
Therefore, our ability to continue to fund our clinical trials and development efforts is highly dependent on the amount of cash and cash equivalents on hand combined with our ability to raise additional capital to support our future operations through one or more methods, including but not limited to, raising additional capital in the equity markets, securing debt financing, licensing or partnering our products in development, or generating additional revenue from Avid. | |||
Historically, we have funded a significant portion of our operations through the issuance of equity. During the nine months ended January 31, 2014, we raised $52,407,000 in aggregate gross proceeds from the sale of shares of our common stock under an At Market Sales Issuance Agreement (Note 7). In February 2014, we raised an additional $19,375,000 in aggregate gross proceeds in connection with a firm commitment underwritten public offering of our newly designated 10.50% Series E Convertible Preferred Stock (the “Series E Preferred Stock”) at a public offering price of $25.00 per share (Note 12). With these proceeds, we currently estimate that we have sufficient cash resources to meet our anticipated cash needs to fund our operations through at least the next twelve months based on our current projections, which includes projected costs associated with our pivotal Phase III SUNRISE trial, projected cash outflows for the payment of dividends on our Series E Preferred Stock, projected cash inflows under signed contracts with existing customers of Avid and assuming we raise no additional capital from the capital markets or other potential sources. | |||
Our ability to raise additional capital in the equity markets to fund our clinical trials and development efforts in future years is dependent on a number of factors, including, but not limited to, the market demand for our common stock and/or Series E Preferred Stock. The market demand or liquidity of our common stock and/or Series E Preferred Stock is subject to a number of risks and uncertainties, including but not limited to, negative economic conditions, adverse market conditions, adverse clinical trial results and significant delays in one or more clinical trials. If our ability to access the capital markets becomes severely restricted, it could have a negative impact on our business plans, including our clinical trial programs and other research and development activities. In addition, even if we are able to raise additional capital, it may not be at a price or on terms that are favorable to us. | |||
While we will continue to explore these potential opportunities, we may not be successful in (i) raising additional capital in the equity markets, (ii) securing debt financing, (iii) licensing or partnering our products in development, or (iv) generating additional revenue from Avid, to complete the research, development, and clinical testing of our product candidates. | |||
Revenue Recognition | ' | ||
We currently derive revenue from two sources: (i) contract manufacturing services provided by Avid, and (ii) licensing revenues related to agreements associated with Peregrine’s technologies under development. | |||
We recognize revenue in accordance with the authoritative guidance for revenue recognition. We recognize revenue when all of the following criteria are met: (i) persuasive evidence of an arrangement exists, (ii) delivery (or passage of title) has occurred or services have been rendered, (iii) the seller’s price to the buyer is fixed or determinable, and (iv) collectability is reasonably assured. We also comply with the authoritative guidance for revenue recognition regarding arrangements with multiple deliverables. | |||
Contract Manufacturing Revenue | |||
Revenue associated with contract manufacturing services provided by Avid is recognized once the service has been rendered and/or upon shipment (or passage of title) of the product to the customer. On occasion, we recognize revenue on a “bill-and-hold” basis in accordance with the authoritative guidance. Under “bill-and-hold” arrangements, revenue is recognized once the product is complete and ready for shipment, title and risk of loss has passed to the customer, management receives a written request from the customer for “bill-and-hold” treatment, the product is segregated from other inventory, and no further performance obligations exist. | |||
In addition, we also follow the authoritative guidance when reporting revenue as gross when we act as a principal versus reporting revenue as net when we act as an agent. For transactions in which we act as a principal, have discretion to choose suppliers, bear credit and inventory risk and perform a substantive part of the services, revenue is recorded at the gross amount billed to a customer and costs associated with these reimbursements are reflected as a component of cost of sales for contract manufacturing services. | |||
Any amounts received prior to satisfying our revenue recognition criteria are recorded as deferred revenue in the accompanying interim unaudited condensed consolidated financial statements. We also record a provision for estimated contract losses, if any, in the period in which they are determined | |||
License Revenue | |||
Revenue associated with licensing agreements primarily consists of non-refundable upfront license fees, non-refundable annual license fees and milestone payments. Non-refundable upfront license fees received under license agreements, whereby continued performance or future obligations are considered inconsequential to the relevant license technology, are recognized as revenue upon delivery of the technology. If a licensing agreement has multiple elements, we analyze each element of our licensing agreements and consider a variety of factors in determining the appropriate method of revenue recognition of each element. | |||
Multiple Element Arrangements. Prior to the adoption of ASU No. 2009-13 on May 1, 2011, if a license agreement has multiple element arrangements, we analyze and determine whether the deliverables, which often include performance obligations, can be separated or whether they must be accounted for as a single unit of accounting in accordance with the authoritative guidance. Under multiple element arrangements, we recognize revenue for delivered elements only when the delivered element has stand-alone value and we have objective and reliable evidence of fair value for each undelivered element. If the fair value of any undelivered element included in a multiple element arrangement cannot be objectively determined, the arrangement would then be accounted for as a single unit of accounting, and revenue is recognized over the estimated period of when the performance obligation(s) are performed. | |||
In addition, under certain circumstances, when there is objective and reliable evidence of the fair value of the undelivered items in an arrangement, but no such evidence for the delivered items, we utilize the residual method to allocate the consideration received under the arrangement. Under the residual method, the amount of consideration allocated to delivered items equals the total arrangement consideration less the aggregate fair value of the undelivered items, and revenue is recognized upon delivery of the undelivered items based on the relative fair value of the undelivered items. | |||
For new licensing agreements or material modifications of existing licensing agreements entered into after May 1, 2011, we follow the provisions of ASU No. 2009-13. If a licensing agreement includes multiple elements, we identify which deliverables represent separate units of accounting, and then determine how the arrangement consideration should be allocated among the separate units of accounting, which may require the use of significant judgment. | |||
If a licensing agreement includes multiple elements, a delivered item is considered a separate unit of accounting if both of the following criteria are met: | |||
1 | The delivered item has value to the licensing partner on a standalone basis based on the consideration of the relevant facts and circumstances for each agreement; | ||
2 | If the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially in the Company’s control. | ||
Arrangement consideration is allocated at the inception of the agreement to all identified units of accounting based on their relative selling price. The relative selling price for each deliverable is determined using vendor specific objective evidence (“VSOE”) of selling price or third-party evidence of selling price if VSOE does not exist. If neither VSOE nor third-party evidence of selling price exists, we use our best estimate of the selling price for the deliverable. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. Changes in the allocation of the sales price between delivered and undelivered elements can impact revenue recognition but do not change the total revenue recognized under any agreement. | |||
Milestone Payments. Effective May 1, 2011, we adopted on a prospective basis the Milestone Method under ASU No. 2010-17 for new licensing agreements or material modifications of existing licensing agreements entered into after May 1, 2011. Under the Milestone Method, we recognize consideration that is contingent upon the achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone is substantive in its entirety. A milestone is considered substantive when it meets all of the following criteria: | |||
1 | The consideration is commensurate with either the entity’s performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone; | ||
2 | The consideration relates solely to past performance; and | ||
3 | The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. | ||
A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity’s performance or on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to the Company. | |||
The provisions of ASU No. 2010-17 do not apply to contingent consideration for which payment is either contingent solely upon the passage of time or the result of a counterparty’s performance. We will assess the nature of, and appropriate accounting for, these payments on a case-by-case basis in accordance with the applicable authoritative guidance for revenue recognition. | |||
Any amounts received prior to satisfying our revenue recognition criteria are recorded as deferred revenue in the accompanying interim unaudited condensed consolidated financial statements. | |||
Fair Value Measurements | ' | ||
We determine fair value measurements in accordance with the authoritative guidance for fair value measurements and disclosures for all assets and liabilities within the scope of this guidance. This guidance, which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The guidance prioritizes the inputs used in measuring fair value into the following hierarchy: | |||
· | Level 1 – Quoted prices in active markets for identical assets or liabilities. | ||
· | Level 2 – Observable inputs other than quoted prices included in Level 1, such as assets or liabilities whose values are based on quoted market prices in markets where trading occurs infrequently or whose values are based on quoted prices of instruments with similar attributes in active markets. | ||
· | Level 3 – Unobservable inputs that are supported by little or no market activity and significant to the overall fair value measurement. | ||
As of January 31, 2014 and April 30, 2013, we do not have any Level 2 or Level 3 financial assets or liabilities and our cash and cash equivalents are carried at fair value based on quoted market prices for identical securities (Level 1 input). | |||
Customer Deposits | ' | ||
Customer deposits primarily represent advance billings and/or payments received from Avid’s third-party customers prior to the initiation of contract manufacturing services. | |||
Research and Development Expenses | ' | ||
Research and development costs are charged to expense when incurred in accordance with the authoritative guidance for research and development costs. Research and development expenses primarily include (i) payroll and related costs associated with research and development personnel, (ii) share-based compensation expense associated with share-based awards granted to research and development personnel, (iii) costs related to clinical and preclinical testing of our technologies under development, (iv) costs to develop and manufacture the product candidates, including raw materials and supplies, product testing, depreciation, and facility related expenses, (v) expenses for research services provided by universities and contract laboratories, including sponsored research funding, and (v) other research and development expenses. | |||
Accrued Clinical Trial and Related Fees | ' | ||
We accrue clinical trial and related fees based on work performed in connection with advancing our clinical trials, which relies on estimates and/or representations from clinical research organizations (“CROs”), hospitals, consultants and other clinical trial related vendors. We maintain regular communication with our vendors, including our CROs, and gauge the reasonableness of estimates provided. However, actual clinical trial costs may differ from estimated clinical trial costs and are adjusted for in the period in which they become known. There were no material adjustments for a change in estimate to research and development expenses in the accompanying interim unaudited condensed consolidated financial statements for the three and nine months ended January 31, 2014 and 2013. | |||
Share-based Compensation | ' | ||
We account for stock options and other share-based awards granted under our equity compensation plans in accordance with the authoritative guidance for share-based compensation. The estimated fair value of share-based payments to employees in exchange for services is measured at the grant date, using a fair value based method, and is recognized as expense on a straight-line basis over the requisite service periods. Share-based compensation expense recognized during the period is based on the value of the portion of the share-based payment that is ultimately expected to vest during the period. | |||
In addition, we periodically grant stock options and other share-based awards to non-employee consultants, which we account for in accordance with the authoritative guidance for share-based compensation. The cost of non-employee services received in exchange for share-based awards are measured based on either the fair value of the consideration received or the fair value of the share-based award issued, whichever is more reliably measurable. In addition, guidance requires share-based compensation related to unvested options and awards issued to non-employees to be recalculated at the end of each reporting period based upon the fair market value on that date until the share-based award has vested, and any adjustment to share-based compensation resulting from the re-measurement is recognized in the current period. See Note 8 for further discussion regarding share-based compensation. | |||
Basic and Dilutive Net Loss Per Common Share | ' | ||
Basic net loss per common share is computed by dividing our net loss by the weighted average number of common shares outstanding during the period excluding the dilutive effects of stock options, common shares expected to be issued under our employee stock purchase plan, and warrants in accordance with the authoritative guidance. Diluted net loss per common share is computed by dividing the net loss by the sum of the weighted average number of common shares outstanding during the period plus the potential dilutive effects of stock options, common shares expected to be issued under our employee stock purchase plan, and warrants outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. Because the impact of options, common shares expected to be issued under our employee stock purchase plan, and warrants are anti-dilutive during periods of net loss, there was no difference between basic and diluted loss per share amounts for the three and nine months ended January 31, 2014 and 2013. | |||
The calculation of weighted average diluted shares outstanding excludes the dilutive effect of outstanding stock options, common shares expected to be issued under our employee stock purchase plan, and warrants, to purchase up to an aggregate of 3,800,577 and 3,984,472 shares of common stock for the three and nine months ended January 31, 2014, respectively, 3,387,483 and 3,500,609 shares of common stock for the three and nine months ended January 31, 2013, respectively, since their impact are anti-dilutive during periods of net loss. | |||
The calculation of weighted average diluted shares outstanding also excludes weighted average outstanding stock options and warrants to purchase up to an aggregate of 5,547,131 and 5,865,858 shares of common stock for the three and nine months ended January 31, 2014, respectively, and 6,053,421 and 6,044,158 shares of common stock for the three and nine months ended January 31, 2013, respectively, as their exercise prices were greater than the average market price of our common stock during the respective periods, resulting in an anti-dilutive effect. |
3_TRADE_AND_OTHER_RECEIVABLES_
3. TRADE AND OTHER RECEIVABLES (Tables) | 9 Months Ended | ||||||||
Jan. 31, 2014 | |||||||||
Receivables [Abstract] | ' | ||||||||
Trade and other receivables | ' | ||||||||
January 31, | April 30, | ||||||||
2014 | 2013 | ||||||||
Trade receivables(1) | $ | 2,769,000 | $ | 1,642,000 | |||||
Other receivables, net | 13,000 | 20,000 | |||||||
Trade and other receivables, net | $ | 2,782,000 | $ | 1,662,000 |
4_PROPERTY_AND_EQUIPMENT_Table
4. PROPERTY AND EQUIPMENT (Tables) | 9 Months Ended | ||||||||
Jan. 31, 2014 | |||||||||
Property, Plant and Equipment [Abstract] | ' | ||||||||
PROPERTY AND EQUIPMENT | ' | ||||||||
January 31, | April 30, | ||||||||
2014 | 2013 | ||||||||
Leasehold improvements | $ | 1,522,000 | $ | 1,383,000 | |||||
Laboratory equipment | 5,558,000 | 5,441,000 | |||||||
Furniture, fixtures, office equipment and software | 2,601,000 | 2,627,000 | |||||||
9,681,000 | 9,451,000 | ||||||||
Less accumulated depreciation and amortization | (7,167,000 | ) | (6,773,000 | ) | |||||
Property and equipment, net | $ | 2,514,000 | $ | 2,678,000 |
5_INVENTORIES_Tables
5. INVENTORIES (Tables) | 9 Months Ended | ||||||||
Jan. 31, 2014 | |||||||||
Inventory Disclosure [Abstract] | ' | ||||||||
INVENTORIES | ' | ||||||||
January 31, | April 30, | ||||||||
2014 | 2013 | ||||||||
Raw materials | $ | 2,303,000 | $ | 2,169,000 | |||||
Work-in-process | 2,921,000 | 2,170,000 | |||||||
Total inventories | $ | 5,224,000 | $ | 4,339,000 |
7_STOCKHOLDERS_EQUITY_Tables
7. STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended | ||||
Jan. 31, 2014 | |||||
Equity [Abstract] | ' | ||||
Shares Of Common Stock Authorized And Reserved For Future Issuance | ' | ||||
Number of Shares | |||||
Reserved | |||||
Common shares reserved for issuance under outstanding option grants and common shares available for issuance under our stock incentive plans | 26,134,940 | ||||
Common shares reserved for and available for issuance under our Employee Stock Purchase Plan | 3,176,777 | ||||
Common shares issuable upon exercise of outstanding warrants | 273,280 | ||||
Total shares of common stock reserved for issuance | 29,584,997 |
8_EQUITY_COMPENSATION_PLANS_Ta
8. EQUITY COMPENSATION PLANS (Tables) | 9 Months Ended | ||||||||||||||||
Jan. 31, 2014 | |||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | ||||||||||||||||
Schedule of stock option transaction activity | ' | ||||||||||||||||
Stock Options | Shares | Weighted Average | |||||||||||||||
Exercisable Price | |||||||||||||||||
Outstanding, May 1, 2013 | 15,287,208 | $1.84 | |||||||||||||||
Granted | 4,615,060 | $1.41 | |||||||||||||||
Exercised | (338,547 | ) | $0.74 | ||||||||||||||
Canceled or expired | (1,337,064 | ) | $4.35 | ||||||||||||||
Outstanding, January 31, 2014 | 18,226,657 | $1.57 | |||||||||||||||
Share-based compensation expense | ' | ||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
January 31, | January 31, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Cost of contract manufacturing | $ | 18,000 | $ | 37,000 | $ | 58,000 | $ | 55,000 | |||||||||
Research and development | 769,000 | 539,000 | 2,231,000 | 1,151,000 | |||||||||||||
Selling, general and administrative | 814,000 | 453,000 | 2,625,000 | 1,114,000 | |||||||||||||
Total | $ | 1,601,000 | $ | 1,029,000 | $ | 4,914,000 | $ | 2,320,000 | |||||||||
Share-based compensation from: | |||||||||||||||||
Stock options | $ | 1,540,000 | $ | 870,000 | $ | 4,549,000 | $ | 2,069,000 | |||||||||
Restricted stock awards | – | – | 139,000 | – | |||||||||||||
Employee stock purchase plan | 61,000 | 159,000 | 226,000 | 251,000 | |||||||||||||
$ | 1,601,000 | $ | 1,029,000 | $ | 4,914,000 | $ | 2,320,000 | ||||||||||
Schedule of restricted stock activity | ' | ||||||||||||||||
Restricted Stock | Shares | Weighted | |||||||||||||||
Average | |||||||||||||||||
Grant Date | |||||||||||||||||
Fair Value | |||||||||||||||||
Unvested, May 1, 2013 | – | $ - | |||||||||||||||
Granted | 100,000 | $1.39 | |||||||||||||||
Vested | (100,000 | ) | $1.39 | ||||||||||||||
Canceled or expired | – | $ - | |||||||||||||||
Unvested, January 31, 2014 | – | $ - |
10_SEGMENT_REPORTING_Tables
10. SEGMENT REPORTING (Tables) | 9 Months Ended | ||||||||||||||||
Jan. 31, 2014 | |||||||||||||||||
Segment Reporting [Abstract] | ' | ||||||||||||||||
Segment information | ' | ||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
January 31, | January 31, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Contract manufacturing services revenue | $ | 3,885,000 | $ | 6,961,000 | $ | 15,820,000 | $ | 17,157,000 | |||||||||
Cost of contract manufacturing services | 2,416,000 | 3,651,000 | 9,281,000 | 9,378,000 | |||||||||||||
Gross profit | 1,469,000 | 3,310,000 | 6,539,000 | 7,779,000 | |||||||||||||
Revenue from products in research and development | – | 78,000 | 107,000 | 272,000 | |||||||||||||
Research and development expense | (6,649,000 | ) | (5,437,000 | ) | (18,910,000 | ) | (18,471,000 | ) | |||||||||
Selling, general and administrative expense | (4,563,000 | ) | (3,112,000 | ) | (12,913,000 | ) | (9,469,000 | ) | |||||||||
Other income, net | 19,000 | 247,000 | 63,000 | 254,000 | |||||||||||||
Loss on early extinguishment of debt | – | – | – | (1,696,000 | ) | ||||||||||||
Net loss | $ | (9,724,000 | ) | $ | (4,914,000 | ) | $ | (25,114,000 | ) | $ | (21,331,000 | ) | |||||
Customer Revenue | ' | ||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
January 31, | January 31, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
United States (customer A) | 87 | % | 60 | % | 88 | % | 78 | % | |||||||||
United States (customer B) | 13 | 2 | 9 | 1 | |||||||||||||
United States (customer C) | – | 37 | 2 | 20 | |||||||||||||
Other customers | – | 1 | 1 | 1 | |||||||||||||
Total | 100% | 100 | % | 100 | % | 100 | % | ||||||||||
2_SUMMARY_OF_SIGNIFICANT_ACCOU2
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Narrative) (USD $) | 3 Months Ended | 9 Months Ended | ||
Jan. 31, 2014 | Jan. 31, 2013 | Jan. 31, 2014 | Jan. 31, 2013 | |
Gross proceeds from stock issuance | ' | ' | 52,407,000 | ' |
Options ESPP Warrants | ' | ' | ' | ' |
Shares which would have dilutive effect if the entity had not been in a loss position | 3,800,577 | 3,387,483 | 3,984,472 | 3,500,609 |
Options and Warrants | ' | ' | ' | ' |
Shares which would have dilutive effect if the entity had not been in a loss position | 5,547,131 | 6,053,421 | 5,865,858 | 6,044,158 |
3_TRADE_AND_OTHER_RECEIVABLES_1
3. TRADE AND OTHER RECEIVABLES (Details) (USD $) | Jan. 31, 2014 | Apr. 30, 2013 | ||
Receivables [Abstract] | ' | ' | ||
Trade receivables | $2,769,000 | [1] | $1,642,000 | [1] |
Other receivables, net | 13,000 | 20,000 | ||
Trade and other receivables, net | $2,782,000 | $1,662,000 | ||
[1] | Represents amounts billed for contract manufacturing services provided by Avid. |
3_TRADE_AND_OTHER_RECEIVABLES_2
3. TRADE AND OTHER RECEIVABLES (Narrative) (USD $) | Jan. 31, 2014 | Apr. 30, 2013 |
Receivables [Abstract] | ' | ' |
Allowance for doubtful accounts | $13,000 | $16,000 |
4_PROPERTY_AND_EQUIPMENT_Detai
4. PROPERTY AND EQUIPMENT (Details) (USD $) | Jan. 31, 2014 | Apr. 30, 2013 |
Property, Plant and Equipment [Abstract] | ' | ' |
Leasehold improvements | $1,522,000 | $1,383,000 |
Laboratory equipment | 5,558,000 | 5,441,000 |
Furniture, fixtures, office equipment and software | 2,601,000 | 2,627,000 |
Property, gross | 9,681,000 | 9,451,000 |
Less accumulated depreciation and amortization | -7,167,000 | -6,773,000 |
Property and equipment, net | $2,514,000 | $2,678,000 |
4_PROPERTY_AND_EQUIPMENT_Narra
4. PROPERTY AND EQUIPMENT (Narrative) (USD $) | 3 Months Ended | 9 Months Ended | ||
Jan. 31, 2014 | Jan. 31, 2013 | Jan. 31, 2014 | Jan. 31, 2013 | |
Property, Plant and Equipment [Abstract] | ' | ' | ' | ' |
Depreciation and amortization | $244,000 | $280,000 | $737,000 | $806,000 |
5_INVENTORIES_Details
5. INVENTORIES (Details) (USD $) | Jan. 31, 2014 | Apr. 30, 2013 |
Inventory Disclosure [Abstract] | ' | ' |
Raw materials | $2,303,000 | $2,169,000 |
Work-in-process | 2,921,000 | 2,170,000 |
Total inventories | $5,224,000 | $4,339,000 |
6_NOTE_PAYABLE_Narrative
6. NOTE PAYABLE (Narrative) (USD $) | 3 Months Ended | 9 Months Ended | ||
Jan. 31, 2014 | Jan. 31, 2013 | Jan. 31, 2014 | Jan. 31, 2013 | |
Debt Disclosure [Abstract] | ' | ' | ' | ' |
Loss on early extinguishment of debt | $0 | $0 | $0 | ($1,696,000) |
Repayment of note payable | ' | ' | 0 | 975,000 |
Unamortized debt issuance cost | ' | ' | 0 | 251,000 |
Fair value of warrants | ' | ' | $0 | $470,000 |
7_STOCKHOLDERS_EQUITY_Details
7. STOCKHOLDERS EQUITY (Details) | Jan. 31, 2014 |
Total shares of common stock reserved for issuance | 29,584,997 |
Stock Incentive Plans | ' |
Total shares of common stock reserved for issuance | 26,134,940 |
Employee Stock Purchase Plan | ' |
Total shares of common stock reserved for issuance | 3,176,777 |
Warrants | ' |
Total shares of common stock reserved for issuance | 273,280 |
7_STOCKHOLDERS_EQUITY_Narrativ
7. STOCKHOLDERS EQUITY (Narrative) (USD $) | 9 Months Ended | |
Jan. 31, 2014 | Jan. 31, 2013 | |
Equity [Abstract] | ' | ' |
Gross proceeds from stock issuance | $52,407,000 | ' |
Shares issued | 31,983,986 | ' |
Stock issuance costs | 1,427,000 | 885,000 |
Aggregate gross proceeds remain available | $9,221,000 | ' |
8_EQUITY_COMPENSATION_PLANS_De
8. EQUITY COMPENSATION PLANS (Details) (USD $) | 9 Months Ended |
Jan. 31, 2014 | |
Stock Options | ' |
Number of Options | ' |
Number of Options Outstanding, Beginning | 15,287,208 |
Number of Options Granted | 4,615,060 |
Number of Options Exercised | -338,547 |
Number of Options Cancelled or Expired | -1,337,064 |
Number of Options Outstanding, Ending | 18,226,657 |
Weighted Average Exercise Price | ' |
Weighted Average Exercise Price Outstanding, Beginning | $1.84 |
Weighted Average Exercise Price Granted | $1.41 |
Weighted Average Exercise Price Exercised | $0.74 |
Weighted Average Exercise Price Canceled | $4.35 |
Weighted Average Exercise Price Outstanding, Ending | $1.57 |
Restricted Stock | ' |
Number of Options | ' |
Number of Options Outstanding, Beginning | 0 |
Number of Options Granted | 100,000 |
Number of Options Exercised | -100,000 |
Number of Options Cancelled or Expired | 0 |
Number of Options Outstanding, Ending | 0 |
Weighted Average Exercise Price | ' |
Weighted Average Exercise Price Outstanding, Beginning | $0 |
Weighted Average Exercise Price Granted | $1.39 |
Weighted Average Exercise Price Exercised | $1.39 |
Weighted Average Exercise Price Canceled | $0 |
Weighted Average Exercise Price Outstanding, Ending | $0 |
8_SHAREBASED_COMPENSATION_Deta
8. SHARE-BASED COMPENSATION (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Jan. 31, 2014 | Jan. 31, 2013 | Jan. 31, 2014 | Jan. 31, 2013 | |
Share based compensation | $1,601,000 | $1,029,000 | $4,914,000 | $2,320,000 |
Stock options | ' | ' | ' | ' |
Share based compensation | 1,540,000 | 870,000 | 4,549,000 | 2,069,000 |
Restricted Stock | ' | ' | ' | ' |
Share based compensation | 0 | 0 | 139,000 | 0 |
Employee Stock Purchase Plan | ' | ' | ' | ' |
Share based compensation | 61,000 | 159,000 | 226,000 | 251,000 |
Cost of contract manufacturing | ' | ' | ' | ' |
Share based compensation | 18,000 | 37,000 | 58,000 | 55,000 |
Research and development | ' | ' | ' | ' |
Share based compensation | 769,000 | 539,000 | 2,231,000 | 1,151,000 |
Selling, general and administrative | ' | ' | ' | ' |
Share based compensation | $814,000 | $453,000 | $2,625,000 | $1,114,000 |
8_EQUITY_COMPENSATION_PLANS_De1
8. EQUITY COMPENSATION PLANS (Details Narrative) (USD $) | 9 Months Ended |
Jan. 31, 2014 | |
Unrecognized compensation cost related to non-vested stock options | $5,452,000 |
Period for expense recognition | '1 year 2 months 5 days |
Shares reserved for issuance under all stock incentive plans | 29,584,997 |
Shares purchased under ESPP | 261,782 |
Stock Incentive Plans | ' |
Shares reserved for issuance under all stock incentive plans | 26,134,940 |
Stock Options | ' |
Shares reserved for issuance under all stock incentive plans | 18,226,657 |
Share-based Awards | ' |
Shares reserved for issuance under all stock incentive plans | 7,908,283 |
9_WARRANTS_Details
9. WARRANTS (Details) (August 30, 2012) | 9 Months Ended |
Jan. 31, 2014 | |
30-Aug-12 | ' |
Warrants outstanding | 273,280 |
Exercise price per share warrants | 2.47 |
Expiration date of warrants | 30-Aug-18 |
10_SEGMENT_REPORTING_Details
10. SEGMENT REPORTING (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Jan. 31, 2014 | Jan. 31, 2013 | Jan. 31, 2014 | Jan. 31, 2013 | |
Segment Reporting [Abstract] | ' | ' | ' | ' |
Contract manufacturing services revenue | $3,885,000 | $6,961,000 | $15,820,000 | $17,157,000 |
Cost of contract manufacturing services | 2,416,000 | 3,651,000 | 9,281,000 | 9,378,000 |
Gross profit | 1,469,000 | 3,310,000 | 6,539,000 | 7,779,000 |
Revenue from products in research and development | 0 | 78,000 | 107,000 | 272,000 |
Research and development expense | -6,649,000 | -5,437,000 | -18,910,000 | -18,471,000 |
Selling, general and administrative expense | -4,563,000 | -3,112,000 | -12,913,000 | -9,469,000 |
Other income, net | 19,000 | 247,000 | 63,000 | 254,000 |
Loss on early extinguishment of debt | 0 | 0 | 0 | -1,696,000 |
Net loss | ($9,724,000) | ($4,914,000) | ($25,114,000) | ($21,331,000) |
10_SEGMENT_REPORTING_Customer_
10. SEGMENT REPORTING (Customer Concentration) | 3 Months Ended | 9 Months Ended | ||
Jan. 31, 2014 | Jan. 31, 2013 | Jan. 31, 2014 | Jan. 31, 2013 | |
Customer revenue as a percentage of revenue | 100.00% | 100.00% | 100.00% | 100.00% |
SalesRevenueSegmentMember | United States (Customer A) | ' | ' | ' | ' |
Customer revenue as a percentage of revenue | 87.00% | 60.00% | 88.00% | 78.00% |
SalesRevenueSegmentMember | United States (Customer B) | ' | ' | ' | ' |
Customer revenue as a percentage of revenue | 13.00% | 2.00% | 9.00% | 1.00% |
SalesRevenueSegmentMember | United States (Customer C) | ' | ' | ' | ' |
Customer revenue as a percentage of revenue | 0.00% | 37.00% | 2.00% | 20.00% |
SalesRevenueSegmentMember | Other Customers | ' | ' | ' | ' |
Customer revenue as a percentage of revenue | 0.00% | 1.00% | 1.00% | 1.00% |