Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Mar. 31, 2016 | May. 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 | Mar. 31, 2016 | |
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 | 22,288,067 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2016 | Sep. 30, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 54,445 | $ 72,218 |
Accounts receivable | 3,532 | 4,461 |
Unbilled accounts receivable | 763 | 812 |
Inventories, net | 3,213 | 2,902 |
Prepaid expenses and other current assets | 955 | 1,367 |
Total current assets | 62,908 | 81,760 |
Restricted cash | 666 | |
Property and equipment, net | 11,298 | 11,593 |
Debt financing costs, net | 652 | 554 |
Intangible assets, net | 6,951 | 6,837 |
TOTAL ASSETS | 82,475 | 100,744 |
Current liabilities: | ||
Accounts payable | 3,412 | 3,952 |
Accrued expenses and other current liabilities | 3,888 | 4,091 |
Long-term debt, current portion | 59 | 57 |
Capital lease obligations, current portion | 492 | 820 |
Recall liability, current portion | 720 | 760 |
Deferred contract revenues, current portion | 341 | 134 |
Total current liabilities | 8,912 | 9,814 |
Long-term debt, net of current portion | 50,660 | 49,807 |
Capital lease obligations, net of current portion | 72 | |
Recall liability, net of current portion | 1,883 | 2,229 |
Deferred contract revenues, net of current portion | 3,500 | 3,500 |
Total liabilities | $ 64,955 | $ 65,422 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock, par value of $0.001 per share, 150,000,000 shares authorized; 22,287,830 and 22,160,991 shares issued and outstanding as of March 31, 2016 and September 30, 2015 | $ 22 | $ 22 |
Additional paid-in capital | 168,167 | 166,085 |
Accumulated deficit | (150,669) | (130,785) |
Total stockholders’ equity | 17,520 | 35,322 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 82,475 | $ 100,744 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2016 | 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 | 22,287,830 | 22,160,991 |
Common stock, shares outstanding | 22,287,830 | 22,160,991 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2016 | Mar. 31, 2015 | Mar. 31, 2016 | Mar. 31, 2015 | |
Revenues: | ||||
Product revenues | $ 5,694 | $ 7,632 | $ 11,666 | $ 14,171 |
Contract research and development revenues | 975 | 3,363 | 2,245 | 6,293 |
Other revenues | 293 | 296 | 588 | 593 |
Total revenues | 6,962 | 11,291 | 14,499 | 21,057 |
Costs and operating expenses: | ||||
Cost of product revenues | 4,000 | 5,219 | 8,298 | 9,306 |
Cost of contract research and development revenues | 2,803 | 4,510 | 5,859 | 8,227 |
Research and development expenses | 5,593 | 3,980 | 10,050 | 8,177 |
General and administrative expenses | 2,973 | 2,670 | 5,990 | 5,357 |
Amortization of intangible assets | 162 | 162 | 321 | 323 |
Loss on disposal of equipment | 2 | 2 | 7 | |
Total costs and operating expenses | 15,533 | 16,541 | 30,520 | 31,397 |
Loss from operations | (8,571) | (5,250) | (16,021) | (10,340) |
Interest income | 58 | 4 | 88 | 6 |
Interest expense | (1,971) | (1,896) | (3,948) | (3,565) |
Loss before income taxes | (10,484) | (7,142) | (19,881) | (13,899) |
Income tax expense | 3 | 2 | ||
Net loss and comprehensive loss | $ (10,484) | $ (7,142) | $ (19,884) | $ (13,901) |
Net loss per share attributable to common stockholders, basic and diluted (in dollars per share) | $ (0.47) | $ (0.40) | $ (0.89) | $ (0.77) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted (in shares) | 22,255,365 | 18,071,320 | 22,221,666 | 18,052,809 |
CONDENSED STATEMENT OF STOCKHOL
CONDENSED STATEMENT OF STOCKHOLDERS' EQUITY - 6 months ended Mar. 31, 2016 - 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 | 267 | 267 | ||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 56,758 | |||
Issuance of common stock upon exercise of stock options | 166 | 166 | ||
Issuance of common stock upon exercise of stock options (in shares) | 70,081 | |||
Stock-based compensation | 1,649 | 1,649 | ||
Net loss and comprehensive loss | (19,884) | (19,884) | ||
Balance at Mar. 31, 2016 | $ 22 | $ 168,167 | $ (150,669) | $ 17,520 |
Balance (in shares) at Mar. 31, 2016 | 22,287,830 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss and comprehensive loss | $ (19,884) | $ (13,901) |
Adjustments to reconcile net loss to net cash used by operating activities: | ||
Depreciation and amortization of property and equipment | 942 | 1,102 |
Loss on disposal of equipment | 2 | 7 |
Amortization of intangible assets | 321 | 323 |
Noncash amortized debt issue costs on long-term debt and capital leases | 103 | 87 |
Noncash amortized discount on long-term debt and capital leases | 10 | 12 |
Stock-based compensation expense | 1,649 | 1,364 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 929 | (723) |
Unbilled accounts receivable | 49 | 153 |
Inventories, net | (311) | (369) |
Prepaid expenses and other current assets | 412 | 606 |
Accounts payable | (566) | 121 |
Accrued expenses and other current liabilities | 679 | 70 |
Deferred contract revenues | 207 | (176) |
Recall liability | (386) | (359) |
Net cash used by operating activities | (15,844) | (11,683) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (624) | (419) |
Payments for patents and licensing rights | (435) | (381) |
Change in restricted cash | (666) | |
Net cash used by investing activities | (1,725) | (800) |
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 | (35) | (33) |
Principal payments on capital lease obligations | (402) | (380) |
Proceeds from exercise of stock options | 166 | 13 |
Proceeds from issuance of common stock under Employee Stock Purchase Plan | 267 | 298 |
Net cash provided (used) by financing activities | (204) | 9,748 |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (17,773) | (2,735) |
CASH AND CASH EQUIVALENTS - Beginning of period | 72,218 | 36,395 |
CASH AND CASH EQUIVALENTS - End of period | 54,445 | 33,660 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 2,954 | 3,466 |
Cash paid for income taxes | 3 | 1 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Property and equipment purchases included in accounts payable | 223 | 154 |
Issuance of payment-in-kind notes in lieu of cash interest payments | $ 882 | $ 786 |
Organization, Description of Bu
Organization, Description of Business, and Summary of Significant Accounting Policies | 6 Months Ended |
Mar. 31, 2016 | |
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 March 31, 2016 and the statements of operations and comprehensive loss for the three and six months ended March 31, 2016 and 2015, statement of stockholders’ equity for the six months ended March 31, 2016 and statements of cash flows for the six months ended March 31, 2016 and 2015 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 March 31, 2016 and its results of operations for the three and six months ended March 31, 2016 and 2015 and cash flows for the six months ended March 31, 2016 and 2015. The financial data and the other financial information contained in these notes to the financial statements related to the three and six month periods are also unaudited. The results of operations for the six months ended March 31, 2016 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 and six months ended March 31, 2016, four partners accounted for 95% of the Company’s revenues and 99% of accounts receivable as of March 31, 2016. These same partners accounted for 84% of accounts receivable as of September 30, 2015. For the three and six months ended March 31, 2015, four partners accounted for 89% of the Company’s revenues. Restricted Cash The Company’s restricted cash consists of cash maintained in a separate deposit account to secure a letter of credit issued by a bank to the landlord under a lease agreement for the Company’s new corporate headquarters. The Company has classified the restricted cash as noncurrent on the condensed balance sheet. Facility Lease 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. In addition, the lease provides that the landlord will reimburse the Company for up to $2.4 million in tenant improvements. Comprehensive Income (Loss) For the three and six months ended March 31, 2016 and 2015, 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. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers, (Topic 606)” (“ASU 2014-09”). This ASU affects any entity that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets, unless those contracts are within the scope of other standards. The guidance in this ASU supersedes the revenue recognition requirements in Topic 605, Revenue Recognition and most industry-specific guidance. The core principle of the guidance is that an entity should recognize revenue upon the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The new guidance also includes a set of disclosure requirements that will provide users of financial statements with comprehensive information about the nature, amount, timing, and uncertainty of revenue and cash flows arising from a reporting organization’s contracts with customers. In August 2015, the Financial Accounting Standards Board issued ASU No. 2015-14, “Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date”, which defers the effective date of ASU 2014-09 by one year. The ASU is effective for annual reporting periods, and interim periods within those years, beginning after December 15, 2017 for public companies and permits the use of either the retrospective or cumulative effect transition method, with early adoption permitted as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within those annual periods. We are currently evaluating the effect, if any, ASU 2014-09 may have on our future financial position, results of operations and cash flows. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) ("ASU 2016-02"), which supersedes existing guidance on accounting for leases in "Leases (Topic 840)" and generally requires all leases to be recognized in the statement of financial position. The provisions of ASU 2016-02 are effective for reporting periods beginning after December 15, 2018. Early adoption is permitted. The provisions of this ASU are to be applied using a modified retrospective approach. We are currently evaluating the effect that this ASU will have on our future financial position, results of operations and cash flows. In March 2016, the FASB issued ASU 2016-09, “Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting” (“ASU 2016-09”). ASU 2016-09 modifies U.S. GAAP by requiring the following, among others: (1) all excess tax benefits and tax deficiencies are to be recognized as income tax expense or benefit on the income statement (excess tax benefits are recognized regardless of whether the benefit reduces taxes payable in the current period); (2) excess tax benefits are to be classified along with other income tax cash flows as an operating activity in the statement of cash flows; (3) in the area of forfeitures, an entity can still follow the current U.S. GAAP practice of making an entity-wide accounting policy election to estimate the number of awards that are expected to vest or may instead account for forfeitures when they occur; and (4) classification as a financing activity in the statement of cash flows of cash paid by an employer to the taxing authorities when directly withholding shares for tax withholding purposes. ASU 2016-09 is effective for annual periods beginning after December 15, 2016, including interim periods. Early adoption is permitted. We are currently evaluating the effect that this ASU will have on our future financial position, results of operations and cash flows. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Mar. 31, 2016 | |
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 March 31, 2016 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 that 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 March 31, 2016 Carrying Fair Value Value Difference Long-term debt $ $ $ As of September 30, 2015 Carrying Fair Value Value Difference Long-term debt $ $ $ |
Inventories
Inventories | 6 Months Ended |
Mar. 31, 2016 | |
Inventories | |
Inventories | 3. Inventories Inventories consist of the following (in thousands): As of March 31, As of September 30, 2016 2015 Raw materials $ $ Work in process Finished goods Total inventories, cost Less inventory reserves Total inventories, net $ $ |
Long-Term Debt
Long-Term Debt | 6 Months Ended |
Mar. 31, 2016 | |
Long-Term Debt. | |
Long-Term Debt | 4. Long-Term Debt Outstanding long-term debt consists of the following (in thousands): As of March 31, As of September 30, 2016 2015 Term loan agreement expiring June 30, 2019, less discount of $51 and $58 as of March 31, 2016 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 March 31, 2016 and September 30, 2015, the Company had converted $5.2 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 March 31, 2016, the principal amount outstanding under the term loan agreement, including all PIK notes, was $50.2 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 | 6 Months Ended |
Mar. 31, 2016 | |
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 March 31, Six Months Ended March 31, 2016 2015 2016 2015 Teva $ $ $ $ Par P&G Agile Other Total revenues $ $ $ $ Included in total revenues above are royalties and profit sharing, which totaled $0.5 million and $1.2 million for the three and six months ended March 31, 2016, compared to $0.6 million and $1.2 million for the corresponding periods in 2015. |
Warrants
Warrants | 6 Months Ended |
Mar. 31, 2016 | |
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 March 31, 2016 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 | 6 Months Ended |
Mar. 31, 2016 | |
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 March 31, 2016 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 March 31, 2016 and September 30, 2015 with a par value of $0.001 per share. As of March 31, 2016, there were 22,287,830 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 filed 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 six months ended March 31, 2016, the Company did not sell any shares under this sales agreement. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Mar. 31, 2016 | |
Stock-Based Compensation | |
Stock-Based Compensation | 8. Stock-Based Compensation Equity Incentive Plans As of March 31, 2016 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 2014 Plan provides for the grant of incentive stock options (ISOs), nonstatutory stock options (NSOs), stock appreciation rights, restricted stock awards, restricted stock unit awards, stock bonus awards, performance-based stock awards, and other forms of equity compensation, all of which may be granted to employees (including officers), non-employee directors and consultants of the Company. 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 11, 2016 and January 16, 2015, the Company’s board of directors authorized an increase of 888,776 and 722,834 shares to be added to the total number of shares of common stock issuable under the 2014 Plan. As of March 31, 2016 and September 30, 2015, the Company had reserved 4,564,068 and 3,745,373 shares of common stock for issuance pursuant to the Corium Plans and had 1,121,886 and 830,396 shares of common stock available for grant pursuant to the 2014 Plan. The term “Corium Plans” refers to the 2014 Plan, the 2012 Plan and the 2002 Stock Option Plan. The exercise price of each option granted 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. The restricted stock unit awards granted under the 2014 Plan typically vest over a four -year period. A summary of activity under the Corium Plans during the six months ended March 31, 2016 is as follows: Weighted Weighted Average Stock Options Average Remaining Aggregate and Awards Exercise Contractual Intrinsic Value Outstanding Price Life (Years) (In thousands) Balance - September 30, 2015 $ $ Options granted $ Restricted stock unit awards granted $ Options exercised $ Options forfeited / cancelled $ Balance - March 31, 2016 $ $ — Options and awards exercisable - March 31, 2016 $ $ Options and awards vested and expected to vest - March 31, 2016 $ $ — All outstanding stock options under the Corium Plans as of March 31, 2016 have an exercise price between $2.12 and $14.12 per share. The weighted-average fair value of the stock options granted for the six months ended March 31, 2016 were estimated using the Black-Scholes option-pricing model with the following assumptions: Six Months Ended March 31, 2016 Expected term (in years) - Risk-free interest rate % - % Expected volatility % - % Expected dividend rate % Expected Term — The expected term represents the period that the stock-based awards are expected to be outstanding before exercise or cancellation. As the Company's historical share exercise experience has not yet provided a reasonable basis upon which to estimate expected term because of a lack of sufficient data points, the Company estimated the expected term by using the midpoint between the vesting commencement date and the contractual expiration period of the stock-based awards. Risk-Free Interest Rate —The risk-free interest rate is based on the constant maturity yields of U.S. Treasury notes with remaining maturities similar to the expected term. Expected Volatility —Because the Company has limited information on the volatility of its common stock due to a lack of significant trading history and limited historical data regarding the volatility of its common stock, the expected volatility used is based on the volatility of a group of comparable publicly-traded companies. In evaluating comparability, the Company considered factors such as industry, stage of life cycle and size. The Company will continue to analyze the historical stock price volatility and term assumptions as more historical data for the Company's common stock becomes available. Expected Dividend Rate —The Company has never paid any dividends, does not plan to pay dividends in the foreseeable future, and, therefore, uses an expected dividend rate of zero in the valuation model. 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 as agreed to by the Company’s board of directors. No more than 4.0 million shares may be issued over the ten -year t erm 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 March 31, 2016 and September 30, 2015, 573,402 and 372,529 shares of common stock were available for issuance pursuant to the 2014 ESPP. For the three and six months ended March 31, 2016 , the Company recorded stock-based compensation expense of $ 61,000 and $138,000 , compared to $111,000 and $275,000 for the corresponding periods in 2015 related to the 2014 ESPP. For the six months ended March 31, 2016 and 2015, the Company issued 56,758 and 61,042 shares of common stock to employees related to the 2014 ESPP. The fair value of the purchase rights granted under the 2014 ESPP between April 2, 2014 and November 20, 2015 were estimated by applying the Black-Scholes option-pricing model to each of the four purchase periods in each offering period using the following assumptions: Six Months Ended March 31, 2016 Fair value of common stock $ – $ Grant price $ – $ Expected term (in years) – Expected volatility % – % Risk-free interest rate % – % Expected dividend rate % Fair Value of Common Stock —The fair market value of the Company’s common stock on the first day of each offering period, or $5.49 for the offering period commencing November 20, 2014 and $6.78 for the offering period commencing on November 20, 2015. Grant Price — 85% of the fair market value of the Company’s common stock on the first day of each offering period, or $4.67 for the offering period commencing November 20, 2014 and $5.76 for the offering period commencing November 20, 2015. Expected Terms —The expected terms are based on the end dates of the four purchase periods of each ESPP offering period, which are six , twelve , eighteen and twenty-four months from the commencement of each new offering period. Expected Volatility —Because the Company has limited information on the volatility of its common stock due to a lack of significant trading history and limited historical data regarding the volatility of its common stock, the expected volatility used is based on the volatility of a group of comparable publicly-traded companies. In evaluating comparability, the Company considered factors such as industry, stage of life cycle and size. The Company will continue to analyze the historical stock price volatility and term assumptions as more historical data for the Company's common stock becomes available. Risk-Free Interest Rate —The risk-free interest rate is based on the constant maturity yields of U.S. Treasury notes with remaining maturities similar to each expected term. Expected Dividend Rate —The Company has never paid any dividends, does not plan to pay dividends in the foreseeable future, and, therefore, uses an expected dividend rate of zero in the valuation model. Stock-Based Compensation Expense Employee stock-based compensation expense for the three and six months ended March 31, 2016 and 2015 is classified in the condensed statements of operations and comprehensive loss as follows (in thousands): Three months ended March 31, Six Months Ended March 31, 2016 2015 2016 2015 Cost of product revenues $ $ $ $ Cost of contract research and development revenues Research and development General and administrative Total stock-based compensation $ $ $ $ As of March 31, 2016 , there was a total of $6.7 million of unrecognized employee stock-based compensation expense, net of estimated forfeitures, related to unvested awards, which is expected to be recognized on a straight-line basis over a weighted-average period of approximately 2.6 years. |
Product Recall Liability
Product Recall Liability | 6 Months Ended |
Mar. 31, 2016 | |
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. The Company made settlement payments of $0.2 million during the three months ended March 31, 2016 and 2015 and $0.4 million during the six months ended March 31, 2016 and 2015. |
Net Loss and Net Loss per Share
Net Loss and Net Loss per Share Attributable to Common Stockholders | 6 Months Ended |
Mar. 31, 2016 | |
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 and six months ended March 31, 2016 and 2015 (in thousands, except share and per share data): Three Months Ended Six Months Ended March 31, March 31, 2016 2015 2016 2015 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 Six Months Ended March 31, March 31, 2016 2015 2016 2015 Stock options to purchase common stock Unvested restricted stock unit awards — — Shares authorized under the 2014 ESPP Common stock warrants |
Income Taxes
Income Taxes | 6 Months Ended |
Mar. 31, 2016 | |
Income Taxes | |
Income Taxes | 11. Income Taxes The Company did not record a provision for Federal income taxes for the three and six months ended March 31, 2016 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 six months ended March 31, 2016 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 | 6 Months Ended |
Mar. 31, 2016 | |
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 | 6 Months Ended |
Mar. 31, 2016 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events On May 10, 2016, we entered into a Lease Amendment #1 (the “Lease Amendment”) with 4741 Talon Court L.L.C. (“Landlord”), which amends the lease agreement, dated April 30, 2012, for our warehouse facility in Grand Rapids, Michigan, located at 4741 Talon Court SE (the “Lease”). The Lease term would have expired on April 30, 2017 and the Lease Amendment extends that term until April 30, 2019. |
Organization, Description of 20
Organization, Description of Business, and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Mar. 31, 2016 | |
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 March 31, 2016 and the statements of operations and comprehensive loss for the three and six months ended March 31, 2016 and 2015, statement of stockholders’ equity for the six months ended March 31, 2016 and statements of cash flows for the six months ended March 31, 2016 and 2015 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 March 31, 2016 and its results of operations for the three and six months ended March 31, 2016 and 2015 and cash flows for the six months ended March 31, 2016 and 2015. The financial data and the other financial information contained in these notes to the financial statements related to the three and six month periods are also unaudited. The results of operations for the six months ended March 31, 2016 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 and six months ended March 31, 2016, four partners accounted for 95% of the Company’s revenues and 99% of accounts receivable as of March 31, 2016. These same partners accounted for 84% of accounts receivable as of September 30, 2015. For the three and six months ended March 31, 2015, four partners accounted for 89% of the Company’s revenues. Restricted Cash The Company’s restricted cash consists of cash maintained in a separate deposit account to secure a letter of credit issued by a bank to the landlord under a lease agreement for the Company’s new corporate headquarters. The Company has classified the restricted cash as noncurrent on the condensed balance sheet. Facility Lease 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. In addition, the lease provides that the landlord will reimburse the Company for up to $2.4 million in tenant improvements. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) For the three and six months ended March 31, 2016 and 2015, 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) | 6 Months Ended |
Mar. 31, 2016 | |
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 March 31, 2016 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 that 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 March 31, 2016 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) | 6 Months Ended |
Mar. 31, 2016 | |
Inventories | |
Schedule of Inventories | Inventories consist of the following (in thousands): As of March 31, As of September 30, 2016 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) | 6 Months Ended |
Mar. 31, 2016 | |
Long-Term Debt. | |
Schedule of the entity's outstanding debt | Outstanding long-term debt consists of the following (in thousands): As of March 31, As of September 30, 2016 2015 Term loan agreement expiring June 30, 2019, less discount of $51 and $58 as of March 31, 2016 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) | 6 Months Ended |
Mar. 31, 2016 | |
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 March 31, Six Months Ended March 31, 2016 2015 2016 2015 Teva $ $ $ $ Par P&G Agile Other Total revenues $ $ $ $ |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Mar. 31, 2016 | |
Stock-Based Compensation | |
Schedule of valuation assumptions used | Six Months Ended March 31, 2016 Expected term (in years) - Risk-free interest rate % - % Expected volatility % - % Expected dividend rate % |
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 and six months ended March 31, 2016 and 2015 is classified in the condensed statements of operations and comprehensive loss as follows (in thousands): Three months ended March 31, Six Months Ended March 31, 2016 2015 2016 2015 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 Options Average Remaining Aggregate and Awards Exercise Contractual Intrinsic Value Outstanding Price Life (Years) (In thousands) Balance - September 30, 2015 $ $ Options granted $ Restricted stock unit awards granted $ Options exercised $ Options forfeited / cancelled $ Balance - March 31, 2016 $ $ — Options and awards exercisable - March 31, 2016 $ $ Options and awards vested and expected to vest - March 31, 2016 $ $ — |
2014 Employee Stock Purchase Plan | |
Stock-Based Compensation | |
Schedule of valuation assumptions used | Six Months Ended March 31, 2016 Fair value of common stock $ – $ Grant price $ – $ Expected term (in years) – Expected volatility % – % Risk-free interest rate % – % Expected dividend rate % |
Net Loss and Net Loss per Sha26
Net Loss and Net Loss per Share Attributable to Common Stockholders (Tables) | 6 Months Ended |
Mar. 31, 2016 | |
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 and six months ended March 31, 2016 and 2015 (in thousands, except share and per share data): Three Months Ended Six Months Ended March 31, March 31, 2016 2015 2016 2015 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 Six Months Ended March 31, March 31, 2016 2015 2016 2015 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 | Mar. 31, 2016 | Mar. 31, 2015 | Mar. 31, 2016 | Mar. 31, 2015 | Sep. 30, 2015 |
Concentration of credit risk | ||||||
Number of partners | 4 | 4 | ||||
Revenues. | Customer concentration | ||||||
Concentration of credit risk | ||||||
Number of partners | 4 | 4 | ||||
Revenues. | Customer concentration | Four partners | ||||||
Concentration of credit risk | ||||||
Concentration risk percentage | 95.00% | 89.00% | 95.00% | 89.00% | ||
Accounts receivable | Credit concentration | ||||||
Concentration of credit risk | ||||||
Number of partners | 4 | |||||
Accounts receivable | Credit concentration | Four partners | ||||||
Concentration of credit risk | ||||||
Concentration risk percentage | 84.00% | 99.00% |
Organization, Description of 28
Organization, Description of Business and Summary of Significant Accounting Policies (Facility Lease) (Details) | Feb. 12, 2016USD ($)ft² | Mar. 31, 2016USD ($) |
Organization, Description of Business, and Summary of Significant Accounting Policies | ||
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% | |
Amount of tenant improvements to be reimbursed by the landlord | $ 2,400,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring basis - Money market funds - USD ($) $ in Thousands | Mar. 31, 2016 | Sep. 30, 2015 |
Financial Assets | ||
Total financial assets | $ 54,583 | $ 71,970 |
Level I | ||
Financial Assets | ||
Total financial assets | $ 54,583 | $ 71,970 |
Fair Value Measurements (Level
Fair Value Measurements (Level III Valuation) (Details) - Level III - USD ($) $ in Thousands | Mar. 31, 2016 | Sep. 30, 2015 |
Carrying Value | ||
Fair value measurements | ||
Long-term debt | $ 50,719 | $ 49,864 |
Fair Value | ||
Fair value measurements | ||
Long-term debt | 50,801 | 49,967 |
Difference | ||
Fair value measurements | ||
Long-term debt | $ 82 | $ 103 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2016 | Sep. 30, 2015 |
Inventories | ||
Raw materials | $ 1,385 | $ 1,573 |
Work in process | 910 | 852 |
Finished goods | 1,020 | 612 |
Total inventories, cost | 3,315 | 3,037 |
Less inventory reserves | (102) | (135) |
Total inventories, net | $ 3,213 | $ 2,902 |
Long-Term Debt (Details)
Long-Term Debt (Details) | Dec. 04, 2014USD ($) | Nov. 14, 2014USD ($) | Dec. 31, 2012USD ($) | Aug. 31, 2012USD ($) | Mar. 31, 2016USD ($)installment | Mar. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2015USD ($) | Mar. 31, 2016USD ($)installment | Jul. 13, 2012USD ($) |
Long-term Debt | ||||||||||
Total | $ 50,719,000 | $ 49,864,000 | $ 49,864,000 | $ 50,719,000 | ||||||
Less current portion | 59,000 | 57,000 | 57,000 | 59,000 | ||||||
Long-term Debt, Excluding Current Maturities | 50,660,000 | 49,807,000 | 49,807,000 | 50,660,000 | ||||||
Proceeds from issuance of long-term debt | $ 10,000,000 | |||||||||
Term loan agreement expiring on June 30, 2019 | ||||||||||
Long-term Debt | ||||||||||
Total | 50,185,000 | 49,295,000 | 49,295,000 | 50,185,000 | ||||||
Unamortized discount | $ 51,000 | 58,000 | 58,000 | $ 51,000 | ||||||
Interest rate (as a percent) | 15.00% | 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 | 4 | ||||||||
Percentage of cash payment the entity can defer by converting interest due into additional notes | 3.50% | |||||||||
Principal amount outstanding | $ 50,200,000 | $ 50,200,000 | ||||||||
Notes payable due April 2017 | ||||||||||
Long-term Debt | ||||||||||
Total | 51,000 | 66,000 | $ 66,000 | $ 51,000 | ||||||
Monthly payments of principal and interest | $ 3,000 | $ 3,000 | ||||||||
Interest rate (as a percent) | 7.00% | 7.00% | 7.00% | 7.00% | ||||||
Notes payable due in November 2024 | ||||||||||
Long-term Debt | ||||||||||
Total | $ 483,000 | $ 503,000 | $ 503,000 | $ 483,000 | ||||||
Monthly payments of principal and interest | $ 6,000 | $ 6,000 | ||||||||
Interest rate (as a percent) | 7.00% | 7.00% | 7.00% | 7.00% | ||||||
Pik notes | ||||||||||
Long-term Debt | ||||||||||
Portion of interest due converted into additional notes | $ 4,400,000 | $ 5,200,000 |
Collaboration and Partner Arr33
Collaboration and Partner Arrangements (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2016 | Mar. 31, 2015 | Mar. 31, 2016 | Mar. 31, 2015 | |
Collaboration and partner arrangements | ||||
Total revenues | $ 6,962 | $ 11,291 | $ 14,499 | $ 21,057 |
Royalties and profit sharing | 500 | 600 | 1,200 | 1,200 |
Teva | ||||
Collaboration and partner arrangements | ||||
Total revenues | 1,277 | 3,922 | 2,795 | 5,826 |
Par | ||||
Collaboration and partner arrangements | ||||
Total revenues | 1,778 | 2,611 | 3,593 | 4,863 |
P&G | ||||
Collaboration and partner arrangements | ||||
Total revenues | 2,815 | 2,539 | 5,902 | 6,216 |
Agile | ||||
Collaboration and partner arrangements | ||||
Total revenues | 762 | 980 | 1,415 | 1,867 |
Other | ||||
Collaboration and partner arrangements | ||||
Total revenues | $ 330 | $ 1,239 | $ 794 | $ 2,285 |
Warrants (Details)
Warrants (Details) - Common stock warrants - $ / shares | 6 Months Ended | |
Mar. 31, 2016 | 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, 35
Convertible Preferred Stock, Common Stock and Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | ||
Dec. 31, 2015 | Mar. 31, 2016 | 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 | 22,287,830 | 22,160,991 | |
Shares sold | 22,287,830 | 22,160,991 | |
Cantor Fitzgerald | |||
Common Stock | |||
Common shares par value (in dollars per share) | $ 0.001 | ||
Aggregate proceeds amount authorized from Controlled Equity Offering Sales Agreement | $ 20 | ||
Shares sold, commission percentage | 3.00% | ||
Shares sold | 0 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) $ / shares in Units, $ in Thousands | Jan. 11, 2016shares | Nov. 20, 2015$ / shares | Jan. 16, 2015shares | Nov. 20, 2014$ / shares | Mar. 20, 2014shares | Mar. 31, 2016USD ($)plan$ / sharesshares | Mar. 31, 2016USD ($)plan$ / sharesshares | Sep. 30, 2015USD ($)plan$ / sharesshares |
Stock-Based Compensation | ||||||||
Number of plans | plan | 3 | 3 | 3 | |||||
Weighted Average Exercise Price | ||||||||
Granted (in dollars per share) | $ / shares | $ 5.76 | $ 4.67 | ||||||
Assumptions used in estimating weighted average fair value of the options granted | ||||||||
Risk-free interest rate, minimum | 1.32% | |||||||
Risk-free interest rate, maximum | 1.97% | |||||||
Expected volatility, minimum | 74.00% | |||||||
Expected volatility, maximum | 77.00% | |||||||
Expected dividend rate (as a percent) | 0.00% | |||||||
Minimum | ||||||||
Assumptions used in estimating weighted average fair value of the options granted | ||||||||
Expected term (in years) | 5 years 3 months 7 days | |||||||
Maximum | ||||||||
Assumptions used in estimating weighted average fair value of the options granted | ||||||||
Expected term (in years) | 6 years 9 months 7 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 | |||||||
Shares of common stock available for grant | 1,121,886 | 1,121,886 | 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 | 4.00% | |||||||
Additional shares authorized | 888,776 | 722,834 | ||||||
2014 Plan | Restricted stock unit awards | ||||||||
Stock-Based Compensation | ||||||||
Vesting period | 4 years | |||||||
Corium Plans | ||||||||
Stock-Based Compensation | ||||||||
Vesting period | 4 years | |||||||
Number of shares of common stock reserved under plan for issuance to employees | 4,564,068 | 4,564,068 | 3,745,373 | |||||
Corium Plans | Maximum | ||||||||
Stock-Based Compensation | ||||||||
Term of the plan | 10 years | |||||||
Corium Plans | Stock options | ||||||||
Stock-Based Compensation | ||||||||
Options granted (in shares) | 619,100 | |||||||
Shares granted (in shares) | 30,000 | |||||||
Grant date fair value (in dollars per share) | $ / shares | $ 7.94 | |||||||
Award activity | ||||||||
Balance at the beginning of the period (in shares) | 2,914,977 | |||||||
Granted (in shares) | 619,100 | |||||||
Restricted stock unit awards granted | 30,000 | |||||||
Exercised (in shares) | (70,081) | |||||||
Forfeited / Cancelled (in shares) | (51,814) | |||||||
Balance at the end of the period (in shares) | 3,442,182 | 3,442,182 | 2,914,977 | |||||
Options and awards exercisable at the end of the period (in shares) | 1,932,612 | 1,932,612 | ||||||
Options and awards vested and expected to vest at the end of the period (in shares) | 3,296,856 | 3,296,856 | ||||||
Weighted Average Exercise Price | ||||||||
Balance at the beginning of the period (in dollars per share) | $ / shares | $ 4.04 | |||||||
Granted (in dollars per share) | $ / shares | 7.72 | |||||||
Restricted stock unit awards, grant date fair value (in dollars per share) | $ / shares | 7.94 | |||||||
Exercised (in dollars per share) | $ / shares | 2.38 | |||||||
Forfeited / Cancelled (in dollars per share) | $ / shares | 4.55 | |||||||
Balance at the end of the period (in dollars per share) | $ / shares | $ 4.69 | 4.69 | $ 4.04 | |||||
Options and awards exercisable at the end of the period (in dollars per share) | $ / shares | 3.26 | 3.26 | ||||||
Options and awards vested and expected to vest at the end of the period (in dollars per share) | $ / shares | $ 4.58 | $ 4.58 | ||||||
Weighted Average Remaining Contractual Life | ||||||||
Balance at the end of the period | 7 years 26 days | 6 years 11 months 9 days | ||||||
Options and awards exercisable at the end of the period | 5 years 8 months 19 days | |||||||
Options and awards vested and expected to vest at the end of the period | 6 years 11 months 23 days | |||||||
Aggregate Intrinsic Value | ||||||||
Balance at the end of the period | $ | $ 15,482 | |||||||
Options and awards exercisable at the end of the period | $ | $ 1,167 | $ 1,167 | ||||||
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 | 573,402 | 573,402 | 372,529 | |||||
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% | |||||||
Assumptions used in estimating weighted average fair value of the options granted | ||||||||
Risk-free interest rate, minimum | 0.07% | |||||||
Risk-free interest rate, maximum | 0.91% | |||||||
Expected volatility, minimum | 47.00% | |||||||
Expected volatility, maximum | 63.00% | |||||||
Expected dividend rate (as a percent) | 0.00% | |||||||
2014 Employee Stock Purchase Plan | Minimum | ||||||||
Weighted Average Exercise Price | ||||||||
Granted (in dollars per share) | $ / shares | $ 4.67 | |||||||
Assumptions used in estimating weighted average fair value of the options granted | ||||||||
Expected term (in years) | 6 months | |||||||
2014 Employee Stock Purchase Plan | Maximum | ||||||||
Weighted Average Exercise Price | ||||||||
Granted (in dollars per share) | $ / shares | $ 5.76 | |||||||
Assumptions used in estimating weighted average fair value of the options granted | ||||||||
Expected term (in years) | 2 years |
Stock-Based Compensation - 2014
Stock-Based Compensation - 2014 Employee Stock Purchase Plan (Details) | Nov. 20, 2015$ / shares | Nov. 20, 2014$ / shares | Mar. 20, 2014shares | Mar. 31, 2016USD ($)$ / sharesshares | Mar. 31, 2015USD ($) | Mar. 31, 2016USD ($)$ / sharesshares | Mar. 31, 2015USD ($)shares | Mar. 31, 2016item$ / sharesshares | Sep. 30, 2015shares |
2014 Employee Stock Purchase Plan | |||||||||
Stock-based compensation | $ | $ 871,000 | $ 676,000 | $ 1,649,000 | $ 1,364,000 | |||||
Assumptions used in estimating weighted average fair value of the shares expected to be purchased | |||||||||
Grant Price | $ 5.76 | $ 4.67 | |||||||
Expected volatility, minimum | 74.00% | ||||||||
Expected volatility, maximum | 77.00% | ||||||||
Risk-free interest rate, minimum | 1.32% | ||||||||
Risk-free interest rate, maximum | 1.97% | ||||||||
Expected dividend rate (as a percent) | 0.00% | ||||||||
Minimum | |||||||||
Assumptions used in estimating weighted average fair value of the shares expected to be purchased | |||||||||
Expected term (in years) | 5 years 3 months 7 days | ||||||||
Maximum | |||||||||
Assumptions used in estimating weighted average fair value of the shares expected to be purchased | |||||||||
Expected term (in years) | 6 years 9 months 7 days | ||||||||
2014 Employee Stock Purchase Plan | |||||||||
2014 Employee Stock Purchase Plan | |||||||||
Term of the plan | 10 years | ||||||||
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% | ||||||||
Maximum number of shares to be issued over the term of the plan | shares | 4,000,000 | ||||||||
Number of shares of common stock reserved under plan for issuance to employees | shares | 573,402 | 573,402 | 573,402 | 372,529 | |||||
Stock-based compensation | $ | $ 61,000 | $ 111,000 | $ 138,000 | $ 275,000 | |||||
Shares issued during the period | shares | 56,758 | 61,042 | |||||||
Number of purchase windows during each offering period | item | 4 | ||||||||
Purchase price of common stock of the lower of the fair market value of the Company's common stock (as a percent) | 85.00% | ||||||||
Assumptions used in estimating weighted average fair value of the shares expected to be purchased | |||||||||
Fair value of common stock | $ 6.78 | $ 5.49 | |||||||
Expected volatility, minimum | 47.00% | ||||||||
Expected volatility, maximum | 63.00% | ||||||||
Risk-free interest rate, minimum | 0.07% | ||||||||
Risk-free interest rate, maximum | 0.91% | ||||||||
Expected dividend rate (as a percent) | 0.00% | ||||||||
Expected term, window one (in months) | 6 months | ||||||||
Expected term, window two (in months) | 12 months | ||||||||
Expected term, window three (in months) | 18 months | ||||||||
Expected term, window four (in months) | 24 months | ||||||||
2014 Employee Stock Purchase Plan | Minimum | |||||||||
Assumptions used in estimating weighted average fair value of the shares expected to be purchased | |||||||||
Fair value of common stock | $ 5.49 | $ 5.49 | $ 5.49 | ||||||
Grant Price | $ 4.67 | ||||||||
Expected term (in years) | 6 months | ||||||||
2014 Employee Stock Purchase Plan | Maximum | |||||||||
Assumptions used in estimating weighted average fair value of the shares expected to be purchased | |||||||||
Fair value of common stock | $ 6.78 | $ 6.78 | $ 6.78 | ||||||
Grant Price | $ 5.76 | ||||||||
Expected term (in years) | 2 years |
Stock-Based Compensation (Stock
Stock-Based Compensation (Stock-Based Compensation Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2016 | Mar. 31, 2015 | Mar. 31, 2016 | Mar. 31, 2015 | |
Employee stock-based compensation expense | ||||
Stock-based compensation | $ 871 | $ 676 | $ 1,649 | $ 1,364 |
Additional Disclosure | ||||
Unrecognized employee compensation cost, net of estimated forfeitures | 6,700 | $ 6,700 | ||
Weighted-average period over which unrecognized compensation cost is expected to be recognized | 2 years 7 months 6 days | |||
Cost of product revenues | ||||
Employee stock-based compensation expense | ||||
Stock-based compensation | 89 | 82 | $ 164 | 185 |
Cost of contract research and development revenues | ||||
Employee stock-based compensation expense | ||||
Stock-based compensation | 49 | 46 | 92 | 103 |
Research and development | ||||
Employee stock-based compensation expense | ||||
Stock-based compensation | 183 | 143 | 340 | 268 |
General and administrative | ||||
Employee stock-based compensation expense | ||||
Stock-based compensation | $ 550 | $ 405 | $ 1,053 | $ 808 |
Product Recall Liability (Detai
Product Recall Liability (Details) $ in Millions | 3 Months Ended | 6 Months Ended | 36 Months Ended | ||||
Mar. 31, 2016USD ($) | Mar. 31, 2015USD ($) | Mar. 31, 2016USD ($) | Mar. 31, 2015USD ($) | Sep. 30, 2011item | Sep. 30, 2010item | Oct. 31, 2012USD ($) | |
Product recall liability | |||||||
Revised combined remaining liability | $ | $ 5 | ||||||
Payment of settlement liability | $ | $ 0.2 | $ 0.2 | $ 0.4 | $ 0.4 | |||
Actavis | |||||||
Product recall liability | |||||||
Number of voluntary recalls of certain lots and strengths of Fentanyl TDS | item | 2 | ||||||
Number of product recalls for which the company negotiated financial statements | item | 2 |
Net Loss and Net Loss per Sha40
Net Loss and Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2016 | Mar. 31, 2015 | Mar. 31, 2016 | Mar. 31, 2015 | |
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 | $ (10,484) | $ (7,142) | $ (19,884) | $ (13,901) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 22,255,365 | 18,071,320 | 22,221,666 | 18,052,809 |
Net loss per share attributable to common stockholders, basic and diluted (in dollars per share) | $ (0.47) | $ (0.40) | $ (0.89) | $ (0.77) |
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 | 3,412,182 | 2,767,810 | 3,412,182 | 2,767,810 |
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 | 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 | 573,402 | 430,952 | 573,402 | 430,952 |
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 | 51,386 | 128,582 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Income Taxes | ||
Income tax expense | $ 3 | $ 2 |
Segment and Enterprise-Wide I42
Segment and Enterprise-Wide Information (Details) | 6 Months Ended |
Mar. 31, 2016item | |
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 |