Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Dec. 31, 2015 | Feb. 10, 2016 | |
Document and Entity Information | ||
Entity Registrant Name | Corium International, Inc. | |
Entity Central Index Key | 1,594,337 | |
Document Type | 10-Q | |
Document Period End Date | Dec. 31, 2015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --09-30 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Trading Symbol | cori | |
Entity Common Stock, Shares Outstanding | 22,220,350 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q1 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2015 | Sep. 30, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 63,028 | $ 72,218 |
Accounts receivable | 3,122 | 4,461 |
Unbilled accounts receivable | 883 | 812 |
Inventories, net | 2,864 | 2,902 |
Prepaid expenses and other current assets | 1,058 | 1,367 |
Total current assets | 70,955 | 81,760 |
Property and equipment, net | 11,603 | 11,593 |
Debt financing costs, net | 706 | 554 |
Intangible assets, net | 6,944 | 6,837 |
TOTAL ASSETS | 90,208 | 100,744 |
Current liabilities: | ||
Accounts payable | 2,746 | 3,952 |
Accrued expenses and other current liabilities | 3,096 | 4,091 |
Long-term debt, current portion | 58 | 57 |
Capital lease obligations, current portion | 694 | 820 |
Recall liability, current portion | 760 | 760 |
Deferred contract revenues, current portion | 104 | 134 |
Total current liabilities | 7,458 | 9,814 |
Long-term debt, net of current portion | 50,234 | 49,807 |
Capital lease obligations, net of current portion | 72 | |
Recall liability, net of current portion | 2,039 | 2,229 |
Deferred contract revenues, net of current portion | 3,500 | 3,500 |
Total liabilities | $ 63,231 | $ 65,422 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock, par value of $0.001 per share, 150,000,000 shares authorized; 22,219,413 and 22,160,991 shares issued and outstanding as of December 31, 2015 and September 30, 2015 | $ 22 | $ 22 |
Additional paid-in capital | 167,140 | 166,085 |
Accumulated deficit | (140,185) | (130,785) |
Total stockholders’ equity | 26,977 | 35,322 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 90,208 | $ 100,744 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2015 | Sep. 30, 2015 |
CONDENSED BALANCE SHEETS | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 22,219,413 | 22,160,991 |
Common stock, shares outstanding | 22,219,413 | 22,160,991 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Revenues: | ||
Product revenues | $ 5,972 | $ 6,539 |
Contract research and development revenues | 1,270 | 2,930 |
Other revenues | 295 | 297 |
Total revenues | 7,537 | 9,766 |
Costs and operating expenses: | ||
Cost of product revenues | 4,298 | 4,087 |
Cost of contract research and development revenues | 3,056 | 3,717 |
Research and development expenses | 4,457 | 4,197 |
General and administrative expenses | 3,017 | 2,687 |
Amortization of intangible assets | 159 | 161 |
Loss on disposal and sale and leaseback of equipment | 7 | |
Total costs and operating expenses | 14,987 | 14,856 |
Loss from operations | (7,450) | (5,090) |
Interest income | 30 | 2 |
Interest expense | (1,977) | (1,669) |
Loss before income taxes | (9,397) | (6,757) |
Income tax expense | 3 | 2 |
Net loss and comprehensive loss | $ (9,400) | $ (6,759) |
Net loss per share attributable to common stockholders, basic and diluted (in dollars per share) | $ (0.42) | $ (0.37) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted (in shares) | 22,188,332 | 18,034,689 |
CONDENSED STATEMENT OF STOCKHOL
CONDENSED STATEMENT OF STOCKHOLDERS' EQUITY - 3 months ended Dec. 31, 2015 - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Sep. 30, 2015 | $ 22 | $ 166,085 | $ (130,785) | $ 35,322 |
Balance (in shares) at Sep. 30, 2015 | 22,160,991 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Issuance of common stock under Employee Stock Purchase Plan | 268 | 268 | ||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 56,758 | |||
Issuance of common stock upon exercise of stock options | 9 | 9 | ||
Issuance of common stock upon exercise of stock options (in shares) | 1,664 | |||
Stock-based compensation | 778 | 778 | ||
Net loss and comprehensive loss | (9,400) | (9,400) | ||
Balance at Dec. 31, 2015 | $ 22 | $ 167,140 | $ (140,185) | $ 26,977 |
Balance (in shares) at Dec. 31, 2015 | 22,219,413 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss and comprehensive loss | $ (9,400) | $ (6,759) |
Adjustments to reconcile net loss to net cash used by operating activities: | ||
Depreciation and amortization of property and equipment | 479 | 553 |
Loss on disposal and sale and leaseback of equipment | 7 | |
Amortization of intangible assets | 159 | 161 |
Noncash amortized debt issue costs on long-term debt and capital leases | 48 | 45 |
Noncash amortized discount on long-term debt and capital leases | 6 | 7 |
Stock-based compensation expense | 778 | 688 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 1,339 | 106 |
Unbilled accounts receivable | (71) | 151 |
Inventories, net | 38 | (874) |
Prepaid expenses and other current assets | 534 | 308 |
Accounts payable | (1,453) | 1,077 |
Accrued expenses and other current liabilities | (554) | (1,163) |
Deferred contract revenues | (30) | 3 |
Recall liability | (190) | (196) |
Net cash used by operating activities | (8,317) | (5,886) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (467) | (328) |
Payments for patents and licensing rights | (266) | (198) |
Net cash used by investing activities | (733) | (526) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of long-term debt | 10,000 | |
Payment of transaction costs associated with issuance of long-term debt and capital leases | (200) | (150) |
Principal payments on long-term debt | (18) | (16) |
Principal payments on capital lease obligations | (199) | (187) |
Proceeds from exercise of stock options | 9 | 9 |
Proceeds from issuance of common stock under Employee Stock Purchase Plan | 268 | 298 |
Net cash provided (used) by financing activities | (140) | 9,954 |
NET INCREASE / (DECREASE) IN CASH AND CASH EQUIVALENTS | (9,190) | 3,542 |
CASH AND CASH EQUIVALENTS - Beginning of period | 72,218 | 36,395 |
CASH AND CASH EQUIVALENTS - End of period | 63,028 | 39,937 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 1,481 | 1,252 |
Cash paid for income taxes | 3 | 1 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Property and equipment purchases included in accounts payable | 220 | 46 |
Issuance of payment-in-kind notes in lieu of cash interest payments | 441 | $ 365 |
Unpaid deferred offering costs | $ 225 |
Organization, Description of Bu
Organization, Description of Business, and Summary of Significant Accounting Policies | 3 Months Ended |
Dec. 31, 2015 | |
Organization, Description of Business, and Summary of Significant Accounting Policies | |
Organization, Description of Business, and Summary of Significant Accounting Policies | CORIUM INTERNATIONAL, INC. Notes to the Condensed Financial Statements 1. Organization, Description of Business and Summary of Significant Accounting Policies Organization Corium International, Inc., a Delaware corporation (the “Company”), is a commercial stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty pharmaceutical products that leverage its broad experience in transdermal and transmucosal delivery systems. In the normal course of business, the Company enters into collaborative agreements with partners to develop and manufacture products based on the Company’s drug delivery technologies and product development expertise. Revenues consist of net sales of products manufactured, royalties and profit-sharing payments based on sales of such products by partners, and product development fees for research and development activities under collaboration agreements with partners. The Company is also engaged in the research and development of its own proprietary transdermal drug delivery products using its Corplex and MicroCor technologies. The Company’s fiscal year ends on September 30. References to “fiscal” refer to the years ended September 30. Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and follow the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. The interim balance sheet as of December 31, 2015 and the statements of operations and comprehensive loss for the three months ended December 31, 2015 and 2014, statement of stockholders’ equity for the three months ended December 31, 2015 and statements of cash flows for the three months ended December 31, 2015 and 2014 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary to present fairly the Company’s financial position as of December 31, 2015 and its results of operations and cash flows for the three months ended December 31, 2015 and 2014. The financial data and the other financial information contained in these notes to the financial statements related to the three month periods are also unaudited. The results of operations for the three months ended December 31, 2015 are not necessarily indicative of the results to be expected for the year ending September 30, 2016 or for any future annual or interim period. The balance sheet as of September 30, 2015 has been derived from the audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. The accompanying condensed financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended September 30, 2015 included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on December 16, 2015. There have been no material changes to the significant accounting policies previously disclosed in the Company’s audited financial statements for the year ended September 30, 2015. Use of Estimates Estimates and assumptions are required to be used by management in the preparation of financial statements in conformity with U.S. GAAP that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of operating revenues and operating expenses during the reporting period. Those estimates and assumptions affect revenue recognition and deferred revenues, impairment of long-lived assets, determination of fair value of stock-based awards and other debt- and equity-related instruments, and accounting for income taxes. As future events and their effects cannot be determined with precision, actual results could differ from those estimates. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash and cash equivalents and accounts receivable. The Company maintains its cash and cash equivalents with a single domestic financial institution that is well capitalized. The Company provides credit, in the normal course of business, to its partners and performs credit evaluations of such partners. For the three months ended December 31, 2015, three partners accounted for 85% of the Company’s revenues and 81% of accounts receivable as of December 31, 2015. These same partners accounted for 84% of accounts receivable as of September 30, 2015. For the three months ended December 31, 2014, four partners accounted for 89% of the Company’s revenues. Comprehensive Income (Loss) During the three months ended December 31, 2015 and 2014, the Company did not recognize any other comprehensive income (loss) and, therefore, the net loss and comprehensive loss was the same for all periods presented. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Dec. 31, 2015 | |
Fair Value Measurements | |
Fair Value Measurements | 2. Fair Value Measurements Financial assets and liabilities are recorded at fair value. Except as noted below, the carrying values of the Company’s financial instruments, including cash equivalents, accounts receivable, and accounts payable, approximated their fair values due to the short period of time to maturity or repayment. Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset, or an exit price that would be paid to transfer a liability, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: Level I —Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level II —Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level III —Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. The Company’s financial assets that are measured at fair value on a recurring basis by level within the fair value hierarchy are as follows (in thousands): As of December 31, 2015 Level I Level II Level III Total Financial Assets: Money market funds $ $ — $ — $ As of September 30, 2015 Level I Level II Level III Total Financial Assets: Money market funds $ $ — $ — $ The following financial liabilities have carrying values which differ from their fair value as estimated by the Company based on market quotes for instruments with similar terms and remaining maturities (Level III valuation) (in thousands): As of December 31, 2015 Carrying Fair Value Value Difference Long-term debt $ $ $ As of September 30, 2015 Carrying Fair Value Value Difference Long-term debt $ $ $ |
Inventories
Inventories | 3 Months Ended |
Dec. 31, 2015 | |
Inventories | |
Inventories | 3. Inventories Inventories consist of the following (in thousands): As of December 31, As of September 30, 2015 2015 Raw materials $ $ Work in process Finished goods Total inventories, cost Less inventory reserves Total inventories, net $ $ |
Long-Term Debt
Long-Term Debt | 3 Months Ended |
Dec. 31, 2015 | |
Long-Term Debt. | |
Long-Term Debt | 4. Long-Term Debt Outstanding long-term debt consists of the following (in thousands): As of December 31, As of September 30, 2015 2015 Term loan agreement expiring June 30, 2019, less discount of $54 and $58 as of December 31, 2015 and September 30, 2015. See terms of the agreement below. $ $ Notes payable to lessor for tenant improvements. The note calls for monthly payments of principal and interest of $3 at an interest rate of 7% and is due April 2017 Notes payable to lessor for tenant improvements. The note calls for monthly payments of principal and interest of $6 at an interest rate of 7% and is due November 2024 Total Less current portion Long-term portion $ $ On July 13, 2012, the Company completed a $35.0 million term loan agreement with CRG, a structured debt and equity investment management firm. In August 2012 and December 2012, the Company drew down $29.0 million and $6.0 million under this agreement. On November 14, 2014, the agreement was amended to, among other things, increase the principal amount available under the term loan by $10.0 million, extend the interest-only period to June 30, 2018, and extend the maturity from June 30, 2017 to June 30, 2019. The amended agreement provides for a maximum borrowing of $45.0 million, excluding PIK notes, as defined below. The amended agreement requires interest to be paid quarterly at a simple annual rate of 15% , and all outstanding principal be repaid in four equal quarterly payments beginning on June 30, 2018, with interest continuing to accrue on the unpaid principal at a simple annual rate of 15% . In addition, the amended agreement contains a provision whereby the Company can, at each quarterly payment due date prior to June 30, 2018, choose to convert that portion of each quarterly interest obligation equal to 3.5% of the then-outstanding principal into additional notes (payment-in-kind (“PIK”) notes). Amounts outstanding under the term loan agreement are collateralized by all of the Company’s assets. The amended agreement also provides for a prepayment penalty, the amount of which varies with the date on which prepayment is made, if the Company chooses to repay principal prior to June 30, 2018 or upon other specified events, including a change of control. On December 4, 2014, the Company borrowed the remaining $10.0 million of principal provided for in the amended agreement. As of December 31, 2015 and September 30, 2015, the Company had converted $4.8 million and $4.4 million of interest into PIK notes, each of which added to the then-outstanding principal, and is included in the balances shown as of those dates. As of December 31, 2015, the principal amount outstanding under the term loan agreement, including all PIK notes, was $49.8 million. The term loan agreement was amended in November 2015 to modify the financial covenants for minimum annual revenues (beginning with the 12 months ended June 30, 2016) and minimum liquidity, with which the Company has been in continuous compliance since the inception of the loan. |
Collaboration and Partner Arran
Collaboration and Partner Arrangements | 3 Months Ended |
Dec. 31, 2015 | |
Collaboration and Partner Arrangements. | |
Collaboration and Partner Arrangements | 5. Collaboration and Partner Arrangements The Company has recognized the following revenues from its collaboration and partner agreements (in thousands): Three Months Ended December 31, 2015 2014 Teva $ $ Par P&G Other Total revenues $ $ Included in total revenues above are royalties and profit sharing totaled $0.7 million and $0.6 million for the three months ended December 31, 2015 and 2014. |
Warrants
Warrants | 3 Months Ended |
Dec. 31, 2015 | |
Warrants | |
Warrants | 6. Warrants The Company issued warrants to purchase shares of the Company's capital stock as part of several transactions from fiscal 2008 through fiscal 2013. The warrants were recorded as equity instruments at the date of their issuances based on the terms of the warrants. As of December 31, 2015 and September 30, 2015, warrants to purchase 51,386 shares of common stock, on an as-converted basis, were outstanding with a weighted-average exercise price of $9.26 per share. All of the common stock warrants are exercisable at any time up to ten years from issuance. The fair value of these warrants was recorded in stockholders’ equity upon issuance. |
Convertible Preferred Stock, Co
Convertible Preferred Stock, Common Stock and Stockholders' Equity | 3 Months Ended |
Dec. 31, 2015 | |
Convertible Preferred Stock, Common Stock and Stockholders' Equity | |
Convertible Preferred Stock, Common Stock and Stockholders' Equity | 7. Convertible Preferred Stock, Common Stock and Stockholders' Equity Convertible Preferred Stock The Company was authorized to issue up to 5.0 million shares of preferred stock as of December 31, 2015 and September 30, 2015 with a par value of $0.001 per share. No preferred stock was outstanding as of those dates. Common Stock The Company was authorized to issue up to 150.0 million shares of common stock as of December 31, 2015 and September 30, 2015 with a par value of $0.001 per share. As of December 31, 2015, there were 22,219,413 shares of common stock outstanding and as of September 30, 2015, there were 22,160,991 shares of common stock outstanding. Controlled Equity Offering In December 2015, the Company entered into a Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co., as agent (“Cantor Fitzgerald”), pursuant to which the Company may offer and sell, from time to time through Cantor Fitzgerald, shares of its common stock, par value $0.001 per share, with aggregate proceeds of up to $20.0 million. The offer and sale of these shares will be made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-204025) filed by the Company with the SEC on May 8, 2015 and declared effective by the SEC on May 21, 2015, as supplemented by a prospectus supplement dated and file d with the SEC on December 30, 2015. The Company will pay Cantor Fitzgerald a commission of 3.0% of the aggregate gross proceeds from any shares sold by Cantor Fitzgerald. During the three months ended December 31, 2015, the Company did not sell any shares under this sales agreement. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Dec. 31, 2015 | |
Stock-Based Compensation | |
Stock-Based Compensation | 8. Stock-Based Compensation Equity Incentive Plans As of December 31, 2015 and September 30, 2015, the Company had three equity incentive plans, all of which are sponsored by the Company. On March 20, 2014, the Company's board of directors approved the adoption of the 2014 Equity Incentive Plan (the "2014 Plan"). Under the 2014 Plan, the Company had initially reserved a total of 1.0 million shares of common stock plus the remaining unissued shares under the Company's 2012 Equity Incentive Plan (the "2012 Plan"), which was adopted in November 2012 and was replaced by the 2014 Plan. The Company also sponsored the 2002 Stock Option Plan that expired in 2012. On January 1 of each year during the ten -year term of the 2014 Plan, the number of shares of common stock issuable under the 2014 Plan will be automatically increased by an amount equal to up to 4% of the number of shares of common stock outstanding as of the preceding December 31, or such lesser number agreed to by the Company’s board of directors. On January 16, 2015, the Company’s board of directors authorized an increase of 722,834 shares to be added to the total number of shares of common stock issuable under the 2014 Plan. As of December 31, 2015 and September 30, 2015, the Company had reserved 3,743,709 and 3,745,373 shares of common stock for issuance pursuant to the Corium Plans and had 251,392 and 830,396 shares of common stock available for grant purs uant to the 2014 Plan. The term “Corium Plans” refers to the 2014 Plan, the 2012 Plan and the 2002 Stock Option Plan. Stock Option Summary The exercise price of each option issued under the Corium Plans is required to be no less than the fair market value of the Company's common stock on the date of the grant. The maximum term of the options is ten years and the vesting period is typically four years. A summary of stock option activity under the Corium Plans during the three months ended December 31, 2015 is as follows: Weighted Weighted Average Stock Average Remaining Aggregate Options Exercise Contractual Intrinsic Value Outstanding Price Life (Years) (In thousands) Balance - September 30, 2015 $ $ Granted $ Exercised $ Forfeited / Cancelled $ Balance - December 31, 2015 $ $ Options exercisable - December 31, 2015 $ $ Options vested and expected to vest - December 31, 2015 $ $ All outstanding options under the Corium Plans as of December 31, 2015 have an exercise price between $2.12 and $14.12 per share. Restricted Stock Unit Summary The Company grants restricted stock unit awards under the 2014 Plan that typically vest over a four - year period. For the three months ended December 31, 2015, the Company granted 30,000 restricted stock unit awards at a grant date fair value of $7.94 . All restricted stock units were unvested as of December 31, 2015. The Company did not grant any restricted stock units during the three months ended December 31, 2014. As of December 31, 2015, there was a total of $0.2 million of unrecognized employee stock-based compensation expense, net of estimated forfeitures, related to unvested restricted stock units, which is expected to be recognized on a straight-line basis over a weighted-average period of approximately 4.1 years 2014 Employee Stock Purchase Plan On March 20, 2014, the Company's board of directors approved the adoption of the 2014 Employee Stock Purchase Plan (the "2014 ESPP"). On January 1 of each year during the ten -year term of the plan, the number of shares issuable under the 2014 ESPP can be increased by an amount equal to up to 1% of the number of shares of common stock and common stock equivalents outstanding as of the preceding December 31, or a lesser number agreed to by the Company’s board of directors. No more than 4.0 million shares may be issued over the ten -year term of the 2014 ESPP without the consent of the Company's stockholders. Shares subject to purchase rights granted under the Company's 2014 ESPP that terminate without having been exercised in full will not reduce the number of shares available for issuance under the Company's 2014 ESPP. The 2014 ESPP is intended to qualify as an "employee stock purchase plan" under Section 423 of the Internal Revenue Code of 1986 with the purpose of providing employees with an opportunity to purchase the Company's common stock through accumulated payroll deductions. As of December 31, 2015 and September 30, 2015, the total reserve available for issuance pursuant to the 2014 ESPP was 315,771 and 372,529 shares of common stock. For the three months ended December 31, 2015 and 2014 , the Company recorded stock-based compensation expense of $ 77,000 and $164,000 and issued 56,758 and 61,042 shares of common stock to employees related to the 2014 ESPP. Stock-Based Compensation Expense Employee stock-based compensation expense for the three months ended December 31, 2015 and 2014 is classified in the condensed statements of operations and comprehensive loss as follows (in thousands): Three months ended December 31, 2015 2014 Cost of product revenues $ $ Cost of contract research and development revenues Research and development General and administrative Total stock-based compensation $ $ As of December 31, 2015 , there was a total of $7.1 million of unrecognized employee stock-based compensation expense, net of estimated forfeitures, related to unvested stock option awards, which is expected to be recognized on a straight-line basis over a weighted-average period of approximately 2.8 years. |
Product Recall Liability
Product Recall Liability | 3 Months Ended |
Dec. 31, 2015 | |
Product Recall Liability | |
Product Recall Liability | 9. Product Recall Liability In fiscal 2008 and fiscal 2010, Allergan, Inc., formerly known as Actavis Inc. (“ Actavis”) issued two voluntary recalls of certain lots and strengths of Fentanyl TDS manufactured by the Company and sold and distributed at that time by Actavis in the United States. The Company and Actavis negotiated financial settlements for these two recalls, and the Company accrued amounts related to these settlements in fiscal 2009 and 2011. These recall liabilities were subsequently reduced through various mechanisms per the terms of the settlement agreements. In October 2012, the Company reached a revised settlement related to the two recalls, which provided for a total and combined remaining liability of $5.0 million as of the settlement date. The revised liability will be repaid through quarterly payments in arrears based on a percentage of the average of the total net revenues recorded by the Company in those prior periods related to Fentanyl TDS. These quarterly payments have been paid to Actavis since July 1, 2013 and will continue through April 1, 2017. To the extent that the revised settlement liability has not been fully repaid as of April 1, 2017, the remaining liability, if any, will be converted into the most recent form of capital stock issued by the Company in connection with a financing, at the price per share of that financing. The revised liability does not accrue interest. During the three months ended December 31, 2015 and 2014, the Company made settlement payments of $0.2 million and $0.2 million. |
Net Loss and Net Loss per Share
Net Loss and Net Loss per Share Attributable to Common Stockholders | 3 Months Ended |
Dec. 31, 2015 | |
Net Loss and Net Loss per Share Attributable to Common Stockholders | |
Net Loss and Net Loss per Share Attributable to Common Stockholders | 10. Net Loss and Net Loss per Share Attributable to Common Stockholders The following table sets forth the computation of the Company's basic and diluted net loss per share attributable to common stockholders during the three months ended December 31, 2015 and 2014 (in thousands, except share and per share data): Three Months Ended December 31, 2015 2014 Basic and diluted net loss per share Net loss attributable to common stockholders, basic and diluted $ $ Weighted average shares used in computing net loss per share attributable to common stockholders, basic and diluted Net loss per share attributable to common stockholders, basic and diluted $ $ The following outstanding shares of common stock equivalents were excluded from the computation of the diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive: Three Months Ended December 31, 2015 2014 Stock options to purchase common stock Unvested restricted stock unit awards — Shares authorized under the 2014 ESPP Common stock warrants |
Income Taxes
Income Taxes | 3 Months Ended |
Dec. 31, 2015 | |
Income Taxes | |
Income Taxes | 11. Income Taxes The Company did not record a provision for Federal income taxes for the three months ended December 31, 2015 because it expects to generate a net operating loss for the year ending September 30, 2016. The income tax expense of $3,000 for the three months ended December 31, 2015 represents minimum statutory payments due in the states in which the Company is subject to taxation. The Company’s deferred tax assets continue to be fully offset by a valuation allowance. |
Segment and Enterprise-Wide Inf
Segment and Enterprise-Wide Information | 3 Months Ended |
Dec. 31, 2015 | |
Segment and Enterprise-Wide Information | |
Segment and Enterprise-Wide Information | 12. Segment and Enterprise-Wide Information The Company’s chief operating decision maker is its President and Chief Executive Officer. The President and Chief Executive Officer reviews the Company’s operating results on an aggregate basis for purposes of allocating resources and evaluating financial performance. The Company has one business activity and there are no segment managers who are held accountable for operations or operating results for levels or components. Accordingly, the Company has a single reporting segment and operating unit structure. All of the Company’s revenues are derived from partners located primarily in North America and all long-lived assets are located in the United States. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Dec. 31, 2015 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events On January 11 , 2016, pursuant to the provisions of the respective plans, the board of directors authorized and approved the registration of 888,776 additional shares of the Company’s common stock subject to issuance by the Company under the 2014 Plan and 257,631 additional shares of the Company’s common stock subject to issuance by the Company under the 2014 ESPP. On February 12 , 2016, the Company entered into a lease agreement pursuant to which the Company will lease approximately 48,240 square feet of space, which will replace the Company’s current headquarters. The lease agreement provides for a term of ten years, commencing on or about August 1, 2016. The Company has an option to extend the term of the lease agreement for an additional seven years. Pursuant to the lease agreement, annual base rent will be approximately $72,360 per month for the first twelve months following the commencement of the term, $110,952 per month for the next twelve months and will increase by approximately 3% annually thereafter. |
Organization, Description of 20
Organization, Description of Business, and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Dec. 31, 2015 | |
Organization, Description of Business, and Summary of Significant Accounting Policies | |
Organization | Organization Corium International, Inc., a Delaware corporation (the “Company”), is a commercial stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty pharmaceutical products that leverage its broad experience in transdermal and transmucosal delivery systems. In the normal course of business, the Company enters into collaborative agreements with partners to develop and manufacture products based on the Company’s drug delivery technologies and product development expertise. Revenues consist of net sales of products manufactured, royalties and profit-sharing payments based on sales of such products by partners, and product development fees for research and development activities under collaboration agreements with partners. The Company is also engaged in the research and development of its own proprietary transdermal drug delivery products using its Corplex and MicroCor technologies. The Company’s fiscal year ends on September 30. References to “fiscal” refer to the years ended September 30. |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and follow the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. The interim balance sheet as of December 31, 2015 and the statements of operations and comprehensive loss for the three months ended December 31, 2015 and 2014, statement of stockholders’ equity for the three months ended December 31, 2015 and statements of cash flows for the three months ended December 31, 2015 and 2014 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary to present fairly the Company’s financial position as of December 31, 2015 and its results of operations and cash flows for the three months ended December 31, 2015 and 2014. The financial data and the other financial information contained in these notes to the financial statements related to the three month periods are also unaudited. The results of operations for the three months ended December 31, 2015 are not necessarily indicative of the results to be expected for the year ending September 30, 2016 or for any future annual or interim period. The balance sheet as of September 30, 2015 has been derived from the audited financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. The accompanying condensed financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto for the year ended September 30, 2015 included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on December 16, 2015. There have been no material changes to the significant accounting policies previously disclosed in the Company’s audited financial statements for the year ended September 30, 2015. |
Use of Estimates | Use of Estimates Estimates and assumptions are required to be used by management in the preparation of financial statements in conformity with U.S. GAAP that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of operating revenues and operating expenses during the reporting period. Those estimates and assumptions affect revenue recognition and deferred revenues, impairment of long-lived assets, determination of fair value of stock-based awards and other debt- and equity-related instruments, and accounting for income taxes. As future events and their effects cannot be determined with precision, actual results could differ from those estimates. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash and cash equivalents and accounts receivable. The Company maintains its cash and cash equivalents with a single domestic financial institution that is well capitalized. The Company provides credit, in the normal course of business, to its partners and performs credit evaluations of such partners. For the three months ended December 31, 2015, three partners accounted for 85% of the Company’s revenues and 81% of accounts receivable as of December 31, 2015. These same partners accounted for 84% of accounts receivable as of September 30, 2015. For the three months ended December 31, 2014, four partners accounted for 89% of the Company’s revenues. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) During the three months ended December 31, 2015 and 2014, the Company did not recognize any other comprehensive income (loss) and, therefore, the net loss and comprehensive loss was the same for all periods presented. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Dec. 31, 2015 | |
Fair Value Measurements | |
Schedule of the Company's financial assets that are measured at fair value on a recurring basis by level within the fair value hierarchy | The Company’s financial assets that are measured at fair value on a recurring basis by level within the fair value hierarchy are as follows (in thousands): As of December 31, 2015 Level I Level II Level III Total Financial Assets: Money market funds $ $ — $ — $ As of September 30, 2015 Level I Level II Level III Total Financial Assets: Money market funds $ $ — $ — $ |
Summary of the changes in the fair value of the Company's Level III financial liabilities, which are measured on a recurring basis | The following financial liabilities have carrying values which differ from their fair value as estimated by the Company based on market quotes for instruments with similar terms and remaining maturities (Level III valuation) (in thousands): As of December 31, 2015 Carrying Fair Value Value Difference Long-term debt $ $ $ As of September 30, 2015 Carrying Fair Value Value Difference Long-term debt $ $ $ |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Dec. 31, 2015 | |
Inventories | |
Schedule of Inventories | Inventories consist of the following (in thousands): As of December 31, As of September 30, 2015 2015 Raw materials $ $ Work in process Finished goods Total inventories, cost Less inventory reserves Total inventories, net $ $ |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 3 Months Ended |
Dec. 31, 2015 | |
Long-Term Debt. | |
Schedule of the entity's outstanding debt | Outstanding long-term debt consists of the following (in thousands): As of December 31, As of September 30, 2015 2015 Term loan agreement expiring June 30, 2019, less discount of $54 and $58 as of December 31, 2015 and September 30, 2015. See terms of the agreement below. $ $ Notes payable to lessor for tenant improvements. The note calls for monthly payments of principal and interest of $3 at an interest rate of 7% and is due April 2017 Notes payable to lessor for tenant improvements. The note calls for monthly payments of principal and interest of $6 at an interest rate of 7% and is due November 2024 Total Less current portion Long-term portion $ $ |
Collaboration and Partner Arr24
Collaboration and Partner Arrangements (Tables) | 3 Months Ended |
Dec. 31, 2015 | |
Collaboration and Partner Arrangements. | |
Schedule of revenues from the entity's collaboration and partner agreements | The Company has recognized the following revenues from its collaboration and partner agreements (in thousands): Three Months Ended December 31, 2015 2014 Teva $ $ Par P&G Other Total revenues $ $ |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Dec. 31, 2015 | |
Stock-based compensation | |
Schedule of employee stock-based compensation expense classified in the statements of operations and comprehensive income (loss) | Employee stock-based compensation expense for the three months ended December 31, 2015 and 2014 is classified in the condensed statements of operations and comprehensive loss as follows (in thousands): Three months ended December 31, 2015 2014 Cost of product revenues $ $ Cost of contract research and development revenues Research and development General and administrative Total stock-based compensation $ $ |
Corium Plans | |
Stock-based compensation | |
Summary of activity under the Plans | Weighted Weighted Average Stock Average Remaining Aggregate Options Exercise Contractual Intrinsic Value Outstanding Price Life (Years) (In thousands) Balance - September 30, 2015 $ $ Granted $ Exercised $ Forfeited / Cancelled $ Balance - December 31, 2015 $ $ Options exercisable - December 31, 2015 $ $ Options vested and expected to vest - December 31, 2015 $ $ |
Net Loss and Net Loss per Sha26
Net Loss and Net Loss per Share Attributable to Common Stockholders (Tables) | 3 Months Ended |
Dec. 31, 2015 | |
Net Loss and Net Loss per Share Attributable to Common Stockholders | |
Schedule of computation of the Company's basic and diluted net loss per share attributable to common stockholders | The following table sets forth the computation of the Company's basic and diluted net loss per share attributable to common stockholders during the three months ended December 31, 2015 and 2014 (in thousands, except share and per share data): Three Months Ended December 31, 2015 2014 Basic and diluted net loss per share Net loss attributable to common stockholders, basic and diluted $ $ Weighted average shares used in computing net loss per share attributable to common stockholders, basic and diluted Net loss per share attributable to common stockholders, basic and diluted $ $ |
Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | Three Months Ended December 31, 2015 2014 Stock options to purchase common stock Unvested restricted stock unit awards — Shares authorized under the 2014 ESPP Common stock warrants |
Organization, Description of 27
Organization, Description of Business, and Summary of Significant Accounting Policies (Details) - Partnership | Sep. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 |
Concentration of credit risk | |||
Number of partners | 3 | ||
Revenues. | Customer concentration | |||
Concentration of credit risk | |||
Number of partners | 4 | ||
Revenues. | Customer concentration | Four partners | |||
Concentration of credit risk | |||
Concentration risk percentage | 89.00% | ||
Revenues. | Customer concentration | Three partners | |||
Concentration of credit risk | |||
Concentration risk percentage | 85.00% | ||
Accounts receivable | Credit concentration | |||
Concentration of credit risk | |||
Number of partners | 3 | ||
Accounts receivable | Credit concentration | Three partners | |||
Concentration of credit risk | |||
Concentration risk percentage | 84.00% | 81.00% |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring basis - Money market funds - USD ($) $ in Thousands | Dec. 31, 2015 | Sep. 30, 2015 |
Financial Assets | ||
Total financial assets | $ 62,811 | $ 71,970 |
Level I | ||
Financial Assets | ||
Total financial assets | $ 62,811 | $ 71,970 |
Fair Value Measurements (Level
Fair Value Measurements (Level III Valuation) (Details) - Level III - USD ($) $ in Thousands | Dec. 31, 2015 | Sep. 30, 2015 |
Carrying Value | ||
Fair value measurements | ||
Long-term debt | $ 50,292 | $ 49,864 |
Fair Value | ||
Fair value measurements | ||
Long-term debt | 50,375 | 49,967 |
Difference | ||
Fair value measurements | ||
Long-term debt | $ 83 | $ 103 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Sep. 30, 2015 |
Inventories | ||
Raw materials | $ 1,512 | $ 1,573 |
Work in process | 742 | 852 |
Finished goods | 706 | 612 |
Total inventories, cost | 2,960 | 3,037 |
Less inventory reserves | (96) | (135) |
Total inventories, net | $ 2,864 | $ 2,902 |
Long-Term Debt (Details)
Long-Term Debt (Details) | Dec. 04, 2014USD ($) | Nov. 14, 2014USD ($) | Dec. 31, 2012USD ($) | Aug. 31, 2012USD ($) | Dec. 31, 2015USD ($)installment | Dec. 31, 2014USD ($) | Sep. 30, 2015USD ($) | Jul. 13, 2012USD ($) |
Long-term Debt | ||||||||
Total | $ 50,292,000 | $ 49,864,000 | ||||||
Less current portion | 58,000 | 57,000 | ||||||
Long-term Debt, Excluding Current Maturities | 50,234,000 | 49,807,000 | ||||||
Proceeds from issuance of long-term debt | $ 10,000,000 | |||||||
Term loan agreement expiring on June 30, 2019 | ||||||||
Long-term Debt | ||||||||
Total | 49,740,000 | 49,295,000 | ||||||
Unamortized discount | $ 54,000 | 58,000 | ||||||
Interest rate (as a percent) | 15.00% | |||||||
Face amount | $ 45,000,000 | $ 35,000,000 | ||||||
Increase in principal amount | $ 10,000,000 | |||||||
Amount drawn | $ 6,000,000 | $ 29,000,000 | ||||||
Proceeds from issuance of long-term debt | $ 10,000,000 | |||||||
Number of quarterly installments for repayment of outstanding principal | installment | 4 | |||||||
Percentage of cash payment the entity can defer by converting interest due into additional notes | 3.50% | |||||||
Portion of interest due converted into additional notes | $ 4,800,000 | 4,400,000 | ||||||
Principal amount outstanding | 49,800,000 | |||||||
Notes payable due April 2017 | ||||||||
Long-term Debt | ||||||||
Total | 59,000 | 66,000 | ||||||
Monthly payments of principal and interest | $ 3,000 | $ 3,000 | ||||||
Interest rate (as a percent) | 7.00% | 7.00% | ||||||
Notes payable due in November 2024 | ||||||||
Long-term Debt | ||||||||
Total | $ 493,000 | $ 503,000 | ||||||
Monthly payments of principal and interest | $ 6,000 | $ 6,000 | ||||||
Interest rate (as a percent) | 7.00% | 7.00% |
Collaboration and Partner Arr32
Collaboration and Partner Arrangements (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Collaboration and partner arrangements | ||
Total revenues | $ 7,537 | $ 9,766 |
Royalties and profit sharing | 700 | 600 |
Teva | ||
Collaboration and partner arrangements | ||
Total revenues | 1,518 | 1,904 |
Par | ||
Collaboration and partner arrangements | ||
Total revenues | 1,814 | 2,308 |
P&G | ||
Collaboration and partner arrangements | ||
Total revenues | 3,087 | 3,677 |
Other | ||
Collaboration and partner arrangements | ||
Total revenues | $ 1,118 | $ 1,877 |
Warrants (Details)
Warrants (Details) - Common stock warrants - $ / shares | 3 Months Ended | |
Dec. 31, 2015 | Sep. 30, 2015 | |
Warrants | ||
Warrants outstanding (in shares) | 51,386 | 51,386 |
Weighted-average exercise price (in dollars per share) | $ 9.26 | $ 9.26 |
Maximum | ||
Warrants | ||
Warrant term | 10 years |
Convertible Preferred Stock, 34
Convertible Preferred Stock, Common Stock and Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | |
Dec. 31, 2015 | Sep. 30, 2015 | |
Preferred Stock | ||
Authorized preferred stock (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock outstanding (in shares) | 0 | 0 |
Common Stock | ||
Common shares authorized | 150,000,000 | 150,000,000 |
Common shares par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares outstanding | 22,219,413 | 22,160,991 |
Aggregate proceeds amount authorized from Controlled Equity Offering Sales Agreement | $ 20 | |
Shares sold, commission percentage | 3.00% |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) | Jan. 16, 2015shares | Mar. 20, 2014shares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)shares | Sep. 30, 2015$ / sharesshares | Dec. 31, 2015USD ($)plan$ / sharesshares | Sep. 30, 2015USD ($)planshares |
Stock-based compensation | |||||||
Number of plans | plan | 3 | 3 | |||||
Number of shares of common stock reserved under plan for issuance to employees | 315,771 | 372,529 | |||||
Stock-based compensation expense | $ | $ 778,000 | $ 688,000 | |||||
Restricted stock unit awards | |||||||
Stock-based compensation | |||||||
Vesting period | 4 years | ||||||
Shares granted (in shares) | 30,000 | 0 | |||||
Grant date fair value (in dollars per share) | $ / shares | $ 7.94 | ||||||
Unrecognized employee stock-based compensation expense, net of estimated forfeitures | $ | $ 200,000 | ||||||
Weighted-average period of recognition | 4 years 1 month 6 days | ||||||
2014 Plan | |||||||
Stock-based compensation | |||||||
Term of the plan | 10 years | ||||||
Number of shares of common stock reserved under plan for issuance to employees | 1,000,000 | ||||||
Maximum annual increase in number of shares issuable by the plan, as a percentage of shares outstanding as of the preceding December 31 | 4.00% | ||||||
Additional shares authorized | 722,834 | ||||||
Shares Available for Grant | |||||||
Additional shares authorized | 722,834 | ||||||
Corium Plans | |||||||
Stock-based compensation | |||||||
Vesting period | 4 years | ||||||
Corium Plans | Maximum | |||||||
Stock-based compensation | |||||||
Term of the plan | 10 years | ||||||
Corium Plans | Stock options | |||||||
Stock-based compensation | |||||||
Options granted (in shares) | 593,200 | ||||||
Shares Available for Grant | |||||||
Granted (in shares) | (593,200) | ||||||
Forfeited / Cancelled (in shares) | 44,196 | ||||||
Stock Options Outstanding | |||||||
Balance at the beginning of the period (in shares) | 2,914,977 | ||||||
Granted (in shares) | 593,200 | ||||||
Exercised (in shares) | (1,664) | ||||||
Forfeited / Cancelled (in shares) | (44,196) | ||||||
Balance at the end of the period (in shares) | 3,462,317 | 2,914,977 | |||||
Options exercisable at the end of the period (in shares) | 1,840,258 | ||||||
Options vested and expected to vest at the end of the period (in shares) | 3,300,208 | ||||||
Weighted Average Exercise Price | |||||||
Balance at the beginning of the period (in dollars per share) | $ / shares | $ 4.04 | ||||||
Granted (in dollars per share) | $ / shares | 7.81 | ||||||
Exercised (in dollars per share) | $ / shares | 5.31 | ||||||
Forfeited / Cancelled (in dollars per share) | $ / shares | 4.32 | ||||||
Balance at the end of the period (in dollars per share) | $ / shares | $ 4.68 | $ 4.04 | |||||
Options exercisable at the end of the period (in dollars per share) | $ / shares | $ 3.04 | ||||||
Options vested and expected to vest at the end of the period (in dollars per share) | $ / shares | $ 4.56 | ||||||
Weighted Average Remaining Contractual Life | |||||||
Balance at the end of the period | 7 years 2 months 23 days | 6 years 11 months 9 days | |||||
Options exercisable at the end of the period | 5 years 8 months 9 days | ||||||
Options vested and expected to vest at the end of the period | 7 years 1 month 17 days | ||||||
Aggregate Intrinsic Value | |||||||
Balance at the end of the period | $ | $ 11,909,000 | $ 15,482,000 | |||||
Options exercisable at the end of the period | $ | 9,342,000 | ||||||
Options vested and expected to vest at the end of the period | $ | $ 11,763,000 | ||||||
Additional disclosures | |||||||
Exercise price, minimum(in dollars per share) | $ / shares | $ 2.12 | ||||||
Exercise price, maximum(in dollars per share) | $ / shares | $ 14.12 | ||||||
2014 Employee Stock Purchase Plan | |||||||
Stock-based compensation | |||||||
Term of the plan | 10 years | ||||||
Number of shares of common stock reserved under plan for issuance to employees | 3,743,709 | 3,745,373 | |||||
Shares of common stock available for grant | 830,396 | 830,396 | 251,392 | 830,396 | |||
Maximum annual increase in number of shares issuable by the plan, as a percentage of shares outstanding as of the preceding December 31 | 1.00% | ||||||
Stock-based compensation expense | $ | $ 77,000 | $ 164,000 | |||||
Maximum number of shares to be issued over the term of the plan | 4,000,000 | ||||||
Shares issued during the period | 56,758 | 61,042 | |||||
Shares Available for Grant | |||||||
Balance at the beginning of the period (in shares) | 830,396 | ||||||
Balance at the end of the period (in shares) | 251,392 | 830,396 |
Stock-Based Compensation (Stock
Stock-Based Compensation (Stock-Based Compensation Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Employee stock-based compensation expense | ||
Stock-based compensation | $ 778 | $ 688 |
Additional Disclosure | ||
Unrecognized employee compensation cost, net of estimated forfeitures | $ 7,100 | |
Weighted-average period over which unrecognized compensation cost is expected to be recognized | 2 years 9 months 18 days | |
Cost of product revenues | ||
Employee stock-based compensation expense | ||
Stock-based compensation | $ 75 | 102 |
Cost of contract research and development revenues | ||
Employee stock-based compensation expense | ||
Stock-based compensation | 43 | 57 |
Research and development | ||
Employee stock-based compensation expense | ||
Stock-based compensation | 157 | 126 |
General and administrative | ||
Employee stock-based compensation expense | ||
Stock-based compensation | $ 503 | $ 403 |
Product Recall Liability (Detai
Product Recall Liability (Details) $ in Millions | 3 Months Ended | 36 Months Ended | ||
Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Sep. 30, 2010item | Oct. 31, 2012USD ($) | |
Product recall liability | ||||
Revised combined remaining liability | $ 5 | |||
Payment of settlement liability | $ 0.2 | $ 0.2 | ||
Actavis | ||||
Product recall liability | ||||
Number of voluntary recalls of certain lots and strengths of Fentanyl TDS | item | 2 |
Net Loss and Net Loss per Sha38
Net Loss and Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | ||
Net loss attributable to common stockholders, basic and diluted | $ (9,400) | $ (6,759) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 22,188,332 | 18,034,689 |
Net loss per share attributable to common stockholders, basic and diluted (in dollars per share) | $ (0.42) | $ (0.37) |
Stock options | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | ||
Number of anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | 3,462,317 | 2,754,789 |
Unvested restricted stock unit awards | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | ||
Number of anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | 30,000 | |
Shares authorized under the 2014 ESPP | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | ||
Number of anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | 315,771 | 248,985 |
Common stock warrants | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | ||
Number of anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | 51,386 | 128,582 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Income Taxes | ||
Income tax expense | $ 3 | $ 2 |
Segment and Enterprise-Wide I40
Segment and Enterprise-Wide Information (Details) | 3 Months Ended |
Dec. 31, 2015item | |
Segment and Enterprise-Wide Information | |
Number of business activities | 1 |
Number of segment managers held accountable for operations or operating results for levels or components | 0 |
Subsequent Events (Details)
Subsequent Events (Details) | Feb. 12, 2016USD ($)ft² | Jan. 11, 2016shares | Jan. 16, 2015shares |
Subsequent event | |||
Subsequent events | |||
Area of property leased | ft² | 48,240 | ||
Lease agreement term | 10 years | ||
Lease agreement extension term | 7 years | ||
Annual base rent for first twelve months | $ | $ 72,360 | ||
Annual base rent for next twelve months | $ | $ 110,952 | ||
Annual increase in base rent (as a percent) | 3.00% | ||
2014 Plan | |||
Subsequent events | |||
Additional shares authorized | 722,834 | ||
2014 Plan | Subsequent event | |||
Subsequent events | |||
Additional shares authorized | 888,776 | ||
2014 Employee Stock Purchase Plan | Subsequent event | |||
Subsequent events | |||
Additional shares authorized | 257,631 |