Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Jun. 30, 2018 | Aug. 07, 2018 | |
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 | Jun. 30, 2018 | |
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 | 36,250,261 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2018 | Sep. 30, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 82,523 | $ 57,466 |
Accounts receivable | 3,556 | 4,641 |
Unbilled accounts receivable | 228 | 169 |
Inventories | 1,686 | 2,300 |
Prepaid expenses and other current assets | 924 | 982 |
Total current assets | 88,917 | 65,558 |
Property and equipment, net | 15,810 | 12,176 |
Intangible assets, net | 7,404 | 7,117 |
TOTAL ASSETS | 112,131 | 84,851 |
Current liabilities: | ||
Accounts payable | 4,519 | 3,978 |
Accrued expenses and other current liabilities | 6,860 | 6,411 |
Long-term debt, current portion | 49 | 13,172 |
Recall liability, current portion | 119 | 114 |
Deferred contract revenues, current portion | 137 | 626 |
Total current liabilities | 11,684 | 24,301 |
Convertible notes, net | 70,021 | |
Long-term debt, net of current portion | 337 | 39,027 |
Recall liability, net of current portion | 1,697 | 1,811 |
Deferred contract revenues, net of current portion | 3,500 | 3,500 |
Total liabilities | 87,239 | 68,639 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Common stock, par value of $0.001 per share, 150,000,000 shares authorized; 36,244,074 and 36,004,602 shares issued and outstanding as of June 30, 2018 and September 30, 2017 | 36 | 36 |
Additional paid-in capital | 283,826 | 231,457 |
Accumulated deficit | (258,970) | (215,281) |
Total stockholders’ equity | 24,892 | 16,212 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 112,131 | $ 84,851 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2018 | Sep. 30, 2017 |
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 | 36,244,074 | 36,004,602 |
Common stock, shares outstanding | 36,244,074 | 36,004,602 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Revenues: | ||||
Product revenues | $ 5,901 | $ 5,906 | $ 18,512 | $ 16,301 |
Contract research and development revenues | 1,529 | 1,936 | 7,813 | 5,320 |
Other revenues | 240 | 267 | 720 | 801 |
Total revenues | 7,670 | 8,109 | 27,045 | 22,422 |
Costs and operating expenses: | ||||
Cost of product revenues | 3,507 | 3,935 | 10,806 | 10,892 |
Cost of contract research and development revenues | 2,339 | 2,977 | 9,238 | 7,891 |
Research and development expenses | 8,305 | 9,122 | 30,511 | 22,650 |
General and administrative expenses | 3,325 | 3,284 | 10,728 | 9,288 |
Amortization of intangible assets | 183 | 159 | 541 | 514 |
Loss on disposal of equipment | 4 | 6 | 4 | 6 |
Total costs and operating expenses | 17,663 | 19,483 | 61,828 | 51,241 |
Loss from operations | (9,993) | (11,374) | (34,783) | (28,819) |
Interest income | 332 | 77 | 617 | 149 |
Interest expense | (3,370) | (2,087) | (7,903) | (6,178) |
Loss on extinguishment of long-term debt | (2,258) | |||
Other income | 640 | 640 | ||
Loss before income taxes | (12,391) | (13,384) | (43,687) | (34,848) |
Income tax expense | 2 | 2 | ||
Net loss and comprehensive loss | $ (12,391) | $ (13,384) | $ (43,689) | $ (34,850) |
Net loss per share attributable to common stockholders, basic and diluted (in dollars per share) | $ (0.34) | $ (0.43) | $ (1.21) | $ (1.30) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted (in shares) | 36,214,740 | 31,457,702 | 36,144,746 | 26,784,678 |
CONDENSED STATEMENT OF STOCKHOL
CONDENSED STATEMENT OF STOCKHOLDERS' EQUITY - 9 months ended Jun. 30, 2018 - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Sep. 30, 2017 | $ 36 | $ 231,457 | $ (215,281) | $ 16,212 |
Balance (in shares) at Sep. 30, 2017 | 36,004,602 | |||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||
Issuance of common stock under Employee Stock Purchase Plan | 427 | 427 | ||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 126,298 | |||
Issuance of common stock upon exercise of stock options | 377 | 377 | ||
Issuance of common stock upon exercise of stock options (in shares) | 108,705 | |||
Issuance of common stock upon net exercise of common stock warrants (in shares) | 4,469 | |||
Equity component of convertible notes, net of issuance costs of $2.5 million | 46,154 | 46,154 | ||
Warrant issued in connection with the convertible note offering | 1,792 | 1,792 | ||
Stock-based compensation expense | 3,619 | 3,619 | ||
Net loss and comprehensive loss | (43,689) | (43,689) | ||
Balance at Jun. 30, 2018 | $ 36 | $ 283,826 | $ (258,970) | $ 24,892 |
Balance (in shares) at Jun. 30, 2018 | 36,244,074 |
CONDENSED STATEMENT OF STOCKHO6
CONDENSED STATEMENT OF STOCKHOLDERS' EQUITY (Parenthetical) $ in Millions | Jun. 30, 2018USD ($) |
STATEMENT OF STOCKHOLDERS' EQUITY | |
Portion of issuance costs allocated to equity component (additional paid-in capital) | $ 2.5 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss and comprehensive loss | $ (43,689) | $ (34,850) |
Adjustments to reconcile net loss to net cash used by operating activities: | ||
Depreciation and amortization of property and equipment | 703 | 801 |
Loss on disposal of equipment | 4 | 6 |
Amortization of intangible assets | 541 | 514 |
Noncash amortized debt discount and issuance costs on convertible notes | 2,379 | |
Noncash amortized debt discount and issuance costs on long-term debt and capital leases | 172 | 285 |
Stock-based compensation expense | 3,619 | 2,711 |
Issuance of payment-in-kind notes in lieu of cash interest payments | 1,369 | |
Loss on extinguishment of long-term debt | 2,258 | |
Other income | (640) | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 1,085 | (241) |
Unbilled accounts receivable | (59) | 86 |
Inventories | 614 | (97) |
Prepaid expenses and other current assets | 58 | 208 |
Accounts payable | 199 | 2,530 |
Accrued expenses and other current liabilities | 974 | 110 |
Deferred contract revenues | (489) | (234) |
Recall liability | (109) | (351) |
Net cash used by operating activities | (32,380) | (27,153) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (3,999) | (1,974) |
Payments for patents and licensing rights | (828) | (813) |
Net cash used by investing activities | (4,827) | (2,787) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of convertible notes | 120,000 | |
Payments of convertible notes issuance costs | (3,772) | |
Proceeds from issuance of common stock, net of issuance costs | 56,136 | |
Principal payments on long-term debt | (52,537) | (58) |
Payments for long-term debt extinguishment costs | (2,231) | |
Principal payments on capital lease obligations | (73) | |
Proceeds from exercise of stock options | 377 | 229 |
Proceeds from issuance of common stock under Employee Stock Purchase Plan | 427 | 436 |
Net cash provided by financing activities | 62,264 | 56,670 |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 25,057 | 26,730 |
CASH AND CASH EQUIVALENTS — Beginning of period | 57,466 | 39,833 |
CASH AND CASH EQUIVALENTS — End of period | 82,523 | 66,563 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 3,434 | 4,524 |
Cash paid for income taxes | 6 | 4 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Property and equipment purchases included in accounts payable | 372 | 310 |
Warrant issued in connection with convertible note offering | $ 1,792 | |
Unpaid transaction costs associated with issuance of long-term debt | $ 544 |
Organization, Description of Bu
Organization, Description of Business, and Summary of Significant Accounting Policies | 9 Months Ended |
Jun. 30, 2018 | |
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 the Company’s broad experience with advanced transdermal and transmucosal delivery systems. The Company refers to its Transdermal Delivery Systems as “TDS.” 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. 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 June 30, 2018, statements of operations and comprehensive loss for the three and nine months ended June 30, 2018 and 2017, statement of stockholders’ equity for the nine months ended June 30, 2018, and statements of cash flows for the nine months ended June 30, 2018 and 2017 are all 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 June 30, 2018, its results of operations for the three and nine months ended June 30, 2018 and 2017, and its cash flows for the nine months ended June 30, 2018 and 2017. The financial data and the other financial information contained in these notes to the financial statements related to the nine-month periods are also unaudited. The results of operations for the nine months ended June 30, 2018 are not necessarily indicative of the results to be expected for the year ending September 30, 2018 or for any future annual or interim period. The balance sheet as of September 30, 2017 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, 2017 included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on December 29, 2017. There have been no material changes to the significant accounting policies or recent accounting pronouncements previously disclosed in the Company’s audited financial statements for the year ended September 30, 2017. Liquidity With the exception of fiscal 2013, the Company has incurred losses from operations since fiscal 2006 and has an accumulated deficit of $259.0 million as of June 30, 2018. The Company has financed its operations primarily through the proceeds from the sale of equity securities, and various debt and capital lease financings. During the nine months ended June 30, 2018, the Company issued $120.0 million aggregate principal amount of convertible notes (the “Convertible Notes”) due in 2025 (see Note 4). The Company used the proceeds from the issuance of the Convertible Notes to prepay in full all outstanding borrowings, fees and other amounts due under the earlier term loan agreement with CRG, a structured debt and equity investment management firm. With the addition of the $61.5 million net proceeds arising from the issuance of the Convertible Notes and simultaneous retirement of the CRG indebtedness, the Company believes that its existing cash and cash equivalents will be sufficient to fund operations as currently planned beyond the next 12 months. Consequently, the Company believes there is no longer substantial doubt regarding its ability to continue as a going concern because the Company is no longer required to maintain compliance with covenants related to liquidity or revenues. The unaudited condensed financial statements as of June 30, 2018 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months. 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, deferred revenues, impairment of long-lived assets, determination of fair value of stock-based awards and other debt- and equity-related instruments, accounting for clinical trial expenses 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 both the three and nine months ended June 30, 2018, three partners accounted for 100% and 99% of the Company’s revenues and three partners accounted for 99% of accounts receivable as of June 30, 2018. For the three and nine months ended June 30, 2017, three partners accounted for 96% and 93% of the Company’s revenues. As of September 30, 2017, three partners accounted for 88% of accounts receivable. Comprehensive Income (Loss) For the three and nine months ended June 30, 2018 and 2017, 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. These ASUs are 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 modified retrospective method, with early adoption permitted as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within those annual periods. In April 2016, the FASB issued ASU 2016-10, “ Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing ” which further clarifies guidance related to identifying performance obligations and licensing implementation guidance contained in ASU 2014-09. In May 2016, the FASB issued ASU 2016-12, “ Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients ” which addresses narrow-scope improvements to the guidance on collectibility, noncash consideration, and completed contracts at transition and provides a practical expedient for contract modifications at transition and an accounting policy election related to the presentation of sales taxes and other similar taxes collected from customers. In December 2016, the FASB issued ASU No. 2016-20, “ Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers ,” which clarifies areas for correction or improvement in the Accounting Standards Codification. The Company will adopt the new revenue recognition standard effective October 1, 2018, utilizing the modified retrospective method. The Company is in the process of evaluating the impact the adoption of this standard will have on its financial statements and has performed an initial review of its major contracts with partners. Based on the initial reviews, the Company believes the adoption of the new standard will not have a significant quantitative impact on product revenues, as the timing of revenue recognition for product sales, profit sharing and royalties is not expected to significantly change. For the Company’s collaboration and partner arrangements, the consideration the Company is eligible to receive under these arrangements typically consists of nonrefundable upfront payments, reimbursement of research and development costs and milestone payments. The Company believes the adoption of the new standard will not have a significant quantitative impact on the revenue recognition of the reimbursement of research and development costs as the timing of the revenue recognition is not expected to significantly change. The Company continues to review the impact that this new standard will have on the timing of recognition for nonrefundable upfront payments and milestone payments as well as on its financial statement disclosures and has not made a determination on the impact to its financial statements. The Company is also evaluating changes to its accounting processes, internal controls and disclosures required to support the new standard. 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 separating leases into liability and asset components to be presented in the statement of financial position. Certain qualitative disclosures are also required to enable users of financial statements to understand the amount, timing, and uncertainty of cash flows arising from leases. The provisions of ASU 2016-02 are effective for annual 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. The Company is evaluating the effect that this ASU will have on the Company’s future financial position, results of operations or cash flows. In May 2017, the FASB issued ASU No. 2017-09, “ Compensation-Stock Compensation (Topic 718) – Scope of Modification Accounting (Topic 718) ”. This ASU clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification, and provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. An entity should account for the effects of a modification unless all three of the following conditions are met: (1) The fair value (or calculated value or intrinsic value, if such an alternative measurement method is used) of the modified award is the same as the fair value (or calculated value or intrinsic value, if such an alternative measurement is used) of the original award immediately before the original award is modified. If the modification does not affect any of the inputs to the valuation technique that the entity uses to value the award, the entity is not required to estimate the value immediately before and after the modification. (2) The vesting conditions of the modified award are the same as the vesting conditions of the original award immediately before the original award is modified. (3) The classification of the modified award as an equity instrument or a liability instrument is the same as the classification of the original award immediately before the original award is modified. This ASU is effective for annual periods beginning after December 15, 2017 and t he Company will adopt the standard effective October 1, 2018 . The adoption of this standard is not expected to have a material impact on the Company’s future financial position, results of operations or cash flows. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Jun. 30, 2018 | |
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 that 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 did not have any transfers between Levels I, II and III of the fair value hierarchy during the three and nine months ended June 30, 2018. The Company’s policy is to determine the need for transfers between levels at the end of the reporting period when circumstances in the underlying valuation criteria are evaluated for changes requiring transfer between levels. 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 June 30, 2018 Level I Level II Level III Total Financial Assets: Money market funds $ 83,012 $ — $ — $ 83,012 As of September 30, 2017 Level I Level II Level III Total Financial Assets: Money market funds $ 57,928 $ — $ — $ 57,928 The Company did not have any Level III liabilities as of September 30, 2017. In March 2018, the Company issued $120.0 million aggregate principal amount of Convertible Notes due 2025 with embedded conversion features. The Company estimated the fair value of the liability component at issuance based on a hypothetical non-convertible debt instrument with a seven-year term, but with a fair market value interest rate derived from a Monte Carlo simulation of the coupon and conversion option outcomes of the Convertible Notes. The Company recorded $71.3 million as the gross fair value of the liability at issuance on March 5, 2018, with the balance of $48.7 million recorded to equity as additional paid-in capital, before issuance costs. The fair value of the liability component is based on unobservable inputs and is, therefore, a Level III liability. As of June 30, 2018, the carrying value of the Convertible Notes liability approximates the fair value, net of issuance costs allocated to it. The carrying value of the Company’s long-term debt as of September 30, 2017 reflects the principal amount, adjusted for any unamortized debt issuance costs and discount. The long-term debt liability as of September 30, 2017 includes $51.8 million of adjusted debt principal relating to the then-outstanding term loan with CRG (see Note 4). The fair value of certain debt liabilities have been estimated by the Company based on market quotes for instruments with similar terms and remaining maturities. The following table lists both the carrying and fair values for such liabilities (in thousands): As of June 30, 2018 Carrying Fair Value Value Difference Long-term debt $ 386 $ 386 $ — As of September 30, 2017 Carrying Fair Value Value Difference Long-term debt $ 52,199 $ 55,888 $ 3,689 |
Inventories
Inventories | 9 Months Ended |
Jun. 30, 2018 | |
Inventories | |
Inventories | 3. Inventories Inventories consist of the following (in thousands): As of June 30, As of September 30, 2018 2017 Raw materials $ 1,076 $ 1,683 Work in process 386 264 Finished goods 224 353 Total inventories $ 1,686 $ 2,300 |
Debt
Debt | 9 Months Ended |
Jun. 30, 2018 | |
Debt | |
Debt | 4. Debt Long-Term Debt Outstanding long-term debt consists of the following (dollars in thousands): As of June 30, As of September 30, 2018 2017 Term loan agreement expiring June 30, 2019, less unamortized issuance costs of $697 and unamortized discount of $27 as of September 30, 2017. See terms of the agreement below. $ — $ 51,779 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 386 420 Total 386 52,199 Less current portion 49 13,172 Long-term portion $ 337 $ 39,027 Term Loan Since 2012, the Company had borrowed $45.0 million from CRG, a structured debt and equity investment management firm, pursuant to a term loan agreement and subsequent amendments to such agreement. The amended agreement provided for a maximum borrowing of $45.0 million, excluding payment-in-kind (“PIK”) notes. The amended agreement required interest to be paid quarterly at a simple annual rate of 15%, and that all outstanding principal be repaid in four equal quarterly payments beginning on September 30, 2018, with interest continuing to accrue on the unpaid principal at a simple annual rate of 15%. In addition, the amended agreement contained a provision whereby the Company could, 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 PIK notes. Since inception of the amended agreement, the Company converted $7.5 million of interest into PIK notes, each of which were added to the then-outstanding principal. Amounts outstanding under the term loan agreement were collateralized by all of the Company’s assets. The amended agreement also provided for a prepayment premium, the amount of which varied with the date on which prepayment was made if the Company chose to repay principal prior to December 31, 2018, or upon other specified events, including a change of control. For the period January 1, 2018 through December 31, 2018, the prepayment premium was equal to 3.25% of the aggregate value of the principal and PIK notes outstanding at the time of prepayment. An additional fee of 1.0% of the aggregate value of the principal and PIK notes outstanding was due at the time of repayment of the loan, whether paid early or upon the maturity date. On March 5, 2018, the Company terminated the term loan agreement with CRG, as amended, and prepaid in full all outstanding borrowings, fees and other amounts due thereunder, in an aggregate amount of approximately $54.8 million plus accrued interest. This amount included total prepayment fees equal to 4.25% of the principal amount then outstanding. The loss on extinguishment of the debt was $2.3 million and is included in the Statement of Operations and Comprehensive Loss for the nine months ended June 30, 2018. The Company was in continuous compliance with the financial covenants from inception through termination of the loan. Convertible Notes In March 2018, the Company issued $120.0 million aggregate principal amount of Convertible Notes due 2025, which aggregate principal amount included the exercise in full by the initial purchaser of the Convertible Notes of an option to purchase $20.0 million of such Convertible Notes. The Convertible Notes are senior, unsecured obligations and accrue interest at an interest rate of 5.00% per year, payable in cash semi-annually in arrears on March 15 and September 15 of each year, beginning on September 15, 2018. The Convertible Notes have a maturity date of March 15, 2025, unless earlier converted or repurchased in accordance with their terms. The Company received $116.2 million in net proceeds from the sale of the Convertible Notes, after deducting payments for offering fees and expenses of $3.8 million. The Convertible Notes were issued pursuant to an indenture, dated as of March 5, 2018, by and between the Company and U.S. Bank National Association, as trustee (the “Indenture”). Pursuant to their terms, the Convertible Notes will be convertible into cash, shares of the Company’s common stock, or a combination of cash and shares of the Company’s common stock, at the Company’s election, as discussed in more detail below. The Convertible Notes have an initial conversion rate of 58.0552 shares of common stock per $1,000 principal amount, which is equivalent to an initial conversion price of approximately $17.22 per share of common stock. The conversion rate and the corresponding conversion price will be subject to adjustment upon the occurrence of certain events, including, but not limited to, stock splits and dividends, rights offerings, cash dividends, or a make-whole fundamental change (as described in the Indenture). The Company may not redeem the Convertible Notes prior to March 15, 2022. The Company may redeem for cash all or any portion of the Convertible Notes, at its option, on or after March 15, 2022 if certain conditions are met, including, but not limited to, if the last reported sales price per share of the Company’s common stock has exceeded 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter. Noteholders may convert their Convertible Notes at their option only in the following circumstances: · at any time during a calendar quarter after June 30, 2018, if the last reported sales price per share of the Company’s common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; · during the five consecutive business days immediately after any five consecutive trading day period (such five consecutive trading day period, referred to as the measurement period) in which the trading price per $1,000 principal amount of Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of the Company’s common stock on such trading day and the conversion rate on such trading day; · upon the occurrence of certain corporate events or distributions on the Company’s common stock; · the Company calls the Convertible Notes for redemption; and · at any time from, and including, September 15, 2024 until the close of business on the scheduled trading day immediately before the maturity date. The Convertible Notes are considered convertible debt with a cash conversion feature. The Company has separated the carrying value of the convertible debt into liability and equity components. The $71.3 million initial carrying amount of the liability component is based on the calculated fair value of a hypothetical non-convertible debt instrument with a seven-year term, but with a fair market value interest rate derived from a Monte Carlo simulation of the coupon and conversion option outcomes of the Convertible Notes. The $48.7 million gross carrying value of the equity component, which amount is also recorded as the initial debt discount, represents the standalone value of the conversion option, and was determined by Monte Carlo simulation. The carrying value of the Convertible Notes equals the aggregate par value of the Convertible Notes less the unamortized debt discount and unamortized debt issuance costs. The debt discount and debt issuance costs are being amortized to interest expense over the seven-year term of the Convertible Notes, using the effective interest rate method. The equity component will not be re-measured as long as it continues to meet the conditions for equity classification. The $46.2 million equity component of the Convertible Notes, which is net of $2.5 million in issuance costs allocated to it, is included in additional paid-in capital. In connection with the issuance of the Convertible Notes, the Company incurred $6.2 million of total debt issuance costs, primarily consisting of underwriting, legal and other professional fees, including a $2.4 million estimate of the fair value of a warrant issued to the initial purchaser (see Note 6), and allocated these costs to the liability and equity components in proportion to their respective carrying values. Of the total debt issuance costs, $3.7 million was allocated to the liability component and is recorded as a reduction of the Convertible Notes carrying value in the balance sheet, while the remaining $2.5 million was allocated to the equity component. Debt discount and issuance costs totaling $52.4 million are being amortized to interest expense over the seven-year life of the Convertible Notes using the effective interest rate method. As of June 30, 2018, the interest rate was 5.00%, and the effective interest rate was 11.21%. Interest expense related to the Convertible Notes for the three and nine months ended June 30, 2018 was $3.4 million and $4.3 million, including $1.9 million and $2.4 million related to the amortization of the debt discount and issuance costs. The table below summarizes the carrying value of the Convertible Notes as of June 30, 2018 (in thousands): Gross proceeds $ 120,000 Portion of proceeds allocated to equity component (additional paid-in capital) (48,671) Debt issuance costs (6,204) Portion of issuance costs allocated to equity component (additional paid-in capital) 2,517 Amortization of debt discount and debt issuance costs 2,379 Carrying value of Convertible Notes $ 70,021 |
Collaboration and Partner Arran
Collaboration and Partner Arrangements | 9 Months Ended |
Jun. 30, 2018 | |
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 June 30, Nine Months Ended June 30, 2018 2017 2018 2017 Mayne $ 1,572 $ 2,207 $ 6,261 $ 4,411 Par — — — 363 P&G 5,149 4,406 14,942 12,519 Agile 949 1,154 5,605 4,014 Other — 342 237 1,115 Total revenues $ 7,670 $ 8,109 $ 27,045 $ 22,422 Included in revenues from Mayne is profit sharing, which totaled $0.2 million and $0.6 million for the three and nine months ended June 30, 2018, compared to $0.1 million and $0.7 million for the corresponding periods in fiscal 2017. |
Warrants
Warrants | 9 Months Ended |
Jun. 30, 2018 | |
Warrants | |
Warrants | 6. Warrants The Company issued warrants to purchase shares of the Company's capital stock as part of several transactions occurring from fiscal 2008 through fiscal 2018. The warrants were recorded as equity instruments at the date of their issuances based on the terms of the warrants. On May 14, 2018 (the “Warrant Issuance Date”), the Company issued a warrant to purchase 350,000 shares of the Company’s common stock to Cantor Fitzgerald (the “Cantor Warrant”) in connection with its role as the initial purchaser of the Company’s offering of the Convertible Notes. The Cantor Warrant has a term of 7 years and a strike price of $17.22 per share. The Company estimated the value of the warrant to be $2.4 million as of a measurement date of March 31, 2018, and recorded that value as an adjustment to equity, and then further adjusted this estimate to the actual fair value of the warrant at issuance, which was $1.8 million as of the Warrant Issuance Date. The change in the value of the warrant from March 31, 2018 to the Warrant Issuance Date was recorded as other income in the Statements of Operations and Comprehensive Loss for the three and nine months ended June 30, 2018. The warrant was treated as an equity instrument, with its initial estimated value of $2.4 million recorded as an additional issuance cost associated with the offering of the Convertible Notes. The total Convertible Notes issuance costs of $6.2 million includes the warrant’s initial estimated value of $2.4 million. The Company estimated the fair value of this warrant as of May 14, 2018 using the Black-Scholes option pricing model with the following key assumptions: Expected term (in years) Risk-free interest rate % Expected volatility % Expected dividend rate % As of June 30, 2018 and September 30, 2017, warrants to purchase 382,380 and 51,386 shares of common stock were outstanding, with a weighted average exercise price of $16.55 and $9.26 per share. These common stock warrants have terms ranging from seven to ten years and are exercisable at any time within the terms. These warrants expire at various dates between December 2020 and May 2025. The fair value of these warrants was recorded in stockholders’ equity upon issuance. During the nine months ended June 30, 2018, warrants to purchase 19,006 shares of common stock were net exercised, resulting in the issuance of 4,469 shares of common stock. |
Convertible Preferred Stock, Co
Convertible Preferred Stock, Common Stock and Stockholders' Equity | 9 Months Ended |
Jun. 30, 2018 | |
Convertible Preferred Stock, Common Stock and Stockholders' Equity - Convertible Preferred Stock | |
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 June 30, 2018 and September 30, 2017 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 June 30, 2018 and September 30, 2017 with a par value of $0.001 per share. As of June 30, 2018, there were 36,244,074 shares of common stock outstanding and as of September 30, 2017, there were 36,004,602 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 Company will pay Cantor Fitzgerald a commission of 3.0% of the aggregate gross proceeds from any shares of common stock sold by Cantor Fitzgerald. The Company has not sold any shares of common stock under this sales agreement. The offer and sale of these shares will require the filing of a new registration statement, or an amendment to an existing one, because the registration statement on Form S-3 that was filed by the Company with the SEC on May 8, 2015 (File No. 333-204025), including the related prospectus that covered the offer and sale of shares pursuant to the agreement with Cantor Fitzgerald, has expired. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Jun. 30, 2018 | |
Stock-Based Compensation | |
Stock-Based Compensation | 8. Stock-Based Compensation Equity Incentive Plans As of June 30, 2018 and September 30, 2017, the Company had three equity incentive plans, all of which are sponsored by the Company. On March 19, 2014, the Company’s board of directors approved the adoption of the 2014 Equity Incentive Plan (the "2014 Plan"), which is the only plan under which the Company can grant new awards. 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. The term “Corium Plans” refers to the 2014 Plan, the 2012 Plan and the 2002 Stock Option Plan. 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 4% of the number of shares of common stock outstanding as of the preceding December 31, unless a lesser number of shares is agreed to by the Company’s board of directors. On January 16, 2018 and January 10, 2017, the Company’s board of directors authorized an increase of 1,444,716 and 902,298 shares to be added to the total number of shares of common stock issuable under the 2014 Plan. As of June 30, 2018 and September 30, 2017, the Company had reserved 6,396,840 and 5,060,829 shares of common stock for issuance pursuant to the 2014 Plan. As of June 30, 2018 and September 30, 2017, the Company had 1,714,127 and 1,129,232 shares of common stock available for issuance pursuant to the 2014 Plan. Stock Options The exercise price of each stock 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 stock options granted under the Corium Plans is ten years and the vesting period is typically four years. A summary of stock option activity under the Corium Plans during the nine months ended June 30, 2018 is as follows: Weighted Weighted Stock Average Remaining Aggregate Options Exercise Contractual Intrinsic Value Outstanding Price Life (Years) (In thousands) Balance - September 30, 2017 3,787,222 $ 4.85 6.84 $ 23,819 Options granted 811,050 $ 11.59 Options exercised (108,705) $ 3.47 Options forfeited / cancelled (20,784) $ 7.48 Options expired (445) $ 2.22 Balance - June 30, 2018 4,468,338 $ 6.10 6.77 $ 11,990 Options exercisable - June 30, 2018 3,085,519 $ 5.01 5.92 $ 10,193 Options vested and expected to vest - June 30, 2018 4,328,101 $ 6.02 6.71 $ 11,835 All outstanding stock options under the Corium Plans as of June 30, 2018 have an exercise price between $2.12 and $14.12 per share. The weighted-average fair value of the stock options granted for the nine months ended June 30, 2018 were estimated using the Black-Scholes option-pricing model with the following assumptions: Nine Months Ended June 30, 2018 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 insufficient information on the volatility of its common stock due to 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. Restricted Stock Unit Awards The fair value of restricted stock unit awards is determined on the grant date based on the fair market value of the Company’s common stock on the date of the grant. The restricted stock unit awards granted under the 2014 Plan have a maximum term of ten years and typically vest over a four-year period. A summary of restricted stock unit award activity under the Corium Plans during the nine months ended June 30, 2018 is as follows: Weighted Average Number of Grant Date Shares Fair Value Nonvested - September 30, 2017 144,375 $ 6.44 Granted 70,000 $ 11.59 Vested (27,502) $ 5.50 Forfeited — $ — Nonvested - June 30, 2018 186,873 $ 8.51 As of June 30, 2018 and September 30, 2017, the Company had 214,375 and 144,375 restricted stock unit awards outstanding. 2014 Employee Stock Purchase Plan On March 19, 2014, the Company's board of directors approved the adoption of the 2014 Employee Stock Purchase Plan (the "2014 ESPP"), with 310,000 shares initially reserved for issuance. 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. On January 1 of each year during the ten-year term of the plan, the number of shares issuable under the 2014 ESPP will be automatically increased by 1% of the number of shares of common stock and common stock equivalents outstanding as of the preceding December 31, unless a lesser number of shares is agreed to by the Company’s board of directors. On January 16, 2018 and January 10, 2017, the Company’s board of directors reserved an additional 409,224 and 267,565 shares of common stock for issuance pursuant to the 2014 ESPP. 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. As of June 30, 2018 and September 30, 2017, there were 919,325 and 636,399 shares of common stock available for issuance pursuant to the 2014 ESPP. For the three and nine months ended June 30, 2018, the Company recorded stock-based compensation expense related to the 2014 ESPP of $73,000 and $146,000 compared to $60,000 and $224,000 for the corresponding periods in fiscal 2017. For the nine months ended June 30, 2018 and 2017, the Company issued 126,298 and 134,855 shares of common stock to employees pursuant to the 2014 ESPP. The fair value of the purchase rights granted under the 2014 ESPP for the current offering periods were estimated by applying the Black-Scholes option-pricing model to each of the four purchase periods in the offering period using the following assumptions : As of June 30, 2018 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. Grant Price — 85% of the fair market value of the Company’s common stock on the first day of the offering period. Expected Term — The expected term is based on the end dates of the four purchase periods of each two year offering period, which are six, twelve, eighteen or twenty-four months from the commencement of each new offering period. Expected Volatility — The expected volatility is based on the historical volatility of the Company’s common stock over each of the expected terms. 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 nine months ended June 30, 2018 and 2017 is classified in the condensed statements of operations and comprehensive loss as follows (in thousands): Three Months Ended June 30, Nine Months Ended June 30, 2018 2017 2018 2017 Cost of product revenues $ 127 $ 93 $ 348 $ 300 Cost of contract research and development revenues 96 61 266 169 Research and development 269 174 750 501 General and administrative 743 592 2,255 1,741 Total stock-based compensation $ 1,235 $ 920 $ 3,619 $ 2,711 As of June 30, 2018, there was a total of $7.7 million of unrecognized employee stock-based compensation expense, net of estimated forfeitures, related to unvested stock-based awards under the Corium Plans, 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 | 9 Months Ended |
Jun. 30, 2018 | |
Product Recall Liability | |
Product Recall Liability | 9. Product Recall Liability In fiscal 2008 and fiscal 2010, 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, and may be pre-paid by the Company in its discretion. These quarterly payments have been paid to Actavis since July 1, 2013. In April 2017, the Company and Actavis mutually agreed to extend the provision for quarterly payments through April 1, 2019, and agreed that, to the extent that the revised settlement liability has not been fully repaid as of April 30, 2019, 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 and nine months ended June 30, 2018, the Company made an immaterial amount of settlement payments to Actavis compared to $0.1 million and $0.3 million for the corresponding periods in fiscal 2017. The outstanding balance of the recall liability was $1.8 million and $1.9 million as of June 30, 2018 and September 30, 2017. |
Net Loss and Net Loss per Share
Net Loss and Net Loss per Share Attributable to Common Stockholders | 9 Months Ended |
Jun. 30, 2018 | |
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 nine months ended June 30, 2018 and 2017 (in thousands, except share and per share data): Three Months Ended Nine Months Ended June 30, June 30, 2018 2017 2018 2017 Basic and diluted net loss per share Net loss attributable to common stockholders, basic and diluted $ (12,391) $ (13,384) $ (43,689) $ (34,850) Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 36,214,740 31,457,702 36,144,746 26,784,678 Net loss per share attributable to common stockholders, basic and diluted $ (0.34) $ (0.43) $ (1.21) $ (1.30) 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 Nine Months Ended June 30, June 30, 2018 2017 2018 2017 Convertible notes 6,968,641 — 6,968,641 — Stock options to purchase common stock 4,468,338 4,058,134 4,468,338 4,058,134 Unvested restricted stock unit awards 186,873 102,500 186,873 102,500 Shares authorized under the 2014 ESPP 919,325 636,399 919,325 636,399 Common stock warrants 382,380 51,386 382,380 51,386 |
Income Taxes
Income Taxes | 9 Months Ended |
Jun. 30, 2018 | |
Income Taxes | |
Income Taxes | 11. Income Taxes The Company did not record a provision for Federal income taxes for the nine months ended June 30, 2018 because it expects to generate a net operating loss for the year ending September 30, 2018. The income tax expense of $2,000 for both the nine month periods ended June 30, 2018 and 2017 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. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “2017 Tax Act”). The 2017 Tax Act makes broad and complex changes to the U.S. tax code and will affect the Company’s fiscal year ending September 30, 2018, including, but not limited to reducing the U.S. federal corporate tax rate from 35 percent to 21 percent and creating limitations on net operating losses (“NOLs”) generated after December 31, 2017. Because the Company’s fiscal years do not coincide with the federal tax year, Section 15 of the Internal Revenue Code requires that the Company’s fiscal year ending September 30, 2018 will have a blended corporate tax rate of 24.53 percent, which is based on the applicable tax rates in effect before and after December 31, 2017 weighted by the number of days in the Company’s 2018 fiscal year before and after December 31, 2017. The SEC staff issued Staff Accounting Bulletin 118 (“SAB 118”), which provides guidance on accounting for the tax effects of the 2017 Tax Act. SAB 118 provides a measurement period that should not extend beyond December 22, 2018 for companies to complete the accounting under ASC 740, “ Income Taxes. ” In accordance with SAB 118, a company must reflect the income tax effects of those aspects of the 2017 Tax Act for which the accounting under ASC 740 is complete. To the extent that a company’s accounting for certain income tax effects of the 2017 Tax Act is incomplete but it is able to determine a reasonable estimate, it must record a provisional estimate in the financial statements. If a company is unable to determine such a provisional estimate, it should continue to apply ASC 740 on the basis of the provisions of the tax laws that were in effect immediately before the enactment of the 2017 Tax Act. Although the Company’s analysis of the 2017 Tax Act is incomplete, it does not currently have the necessary information available, prepared, or analyzed in sufficient detail to make reasonable estimates of the impact of the 2017 Tax Act on the Company’s financial statements, the Company expects there will be no impact on the Company’s financial statements due to the full valuation allowance applied to the Company’s deferred tax assets. The 2017 Tax Act also limits the use of Net Operating Loss carryforwards (or “NOLs”) generated after December 31, 2017 to 80% of taxable income. The Company does not expect profitability in the near term, nor has it conducted an analysis on its NOLs generated to date, so the future impact of such NOL limitations is not yet known. |
Segment and Enterprise-Wide Inf
Segment and Enterprise-Wide Information | 9 Months Ended |
Jun. 30, 2018 | |
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 conducting their business involving the Company’s products and services primarily in North America and all long-lived assets are located in the United States. |
Organization, Description of 20
Organization, Description of Business, and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Jun. 30, 2018 | |
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 the Company’s broad experience with advanced transdermal and transmucosal delivery systems. The Company refers to its Transdermal Delivery Systems as “TDS.” 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. 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 June 30, 2018, statements of operations and comprehensive loss for the three and nine months ended June 30, 2018 and 2017, statement of stockholders’ equity for the nine months ended June 30, 2018, and statements of cash flows for the nine months ended June 30, 2018 and 2017 are all 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 June 30, 2018, its results of operations for the three and nine months ended June 30, 2018 and 2017, and its cash flows for the nine months ended June 30, 2018 and 2017. The financial data and the other financial information contained in these notes to the financial statements related to the nine-month periods are also unaudited. The results of operations for the nine months ended June 30, 2018 are not necessarily indicative of the results to be expected for the year ending September 30, 2018 or for any future annual or interim period. The balance sheet as of September 30, 2017 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, 2017 included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on December 29, 2017. There have been no material changes to the significant accounting policies or recent accounting pronouncements previously disclosed in the Company’s audited financial statements for the year ended September 30, 2017. |
Liquidity | Liquidity With the exception of fiscal 2013, the Company has incurred losses from operations since fiscal 2006 and has an accumulated deficit of $259.0 million as of June 30, 2018. The Company has financed its operations primarily through the proceeds from the sale of equity securities, and various debt and capital lease financings. During the nine months ended June 30, 2018, the Company issued $120.0 million aggregate principal amount of convertible notes (the “Convertible Notes”) due in 2025 (see Note 4). The Company used the proceeds from the issuance of the Convertible Notes to prepay in full all outstanding borrowings, fees and other amounts due under the earlier term loan agreement with CRG, a structured debt and equity investment management firm. With the addition of the $61.5 million net proceeds arising from the issuance of the Convertible Notes and simultaneous retirement of the CRG indebtedness, the Company believes that its existing cash and cash equivalents will be sufficient to fund operations as currently planned beyond the next 12 months. Consequently, the Company believes there is no longer substantial doubt regarding its ability to continue as a going concern because the Company is no longer required to maintain compliance with covenants related to liquidity or revenues. The unaudited condensed financial statements as of June 30, 2018 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months. |
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, deferred revenues, impairment of long-lived assets, determination of fair value of stock-based awards and other debt- and equity-related instruments, accounting for clinical trial expenses 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 both the three and nine months ended June 30, 2018, three partners accounted for 100% and 99% of the Company’s revenues and three partners accounted for 99% of accounts receivable as of June 30, 2018. For the three and nine months ended June 30, 2017, three partners accounted for 96% and 93% of the Company’s revenues. As of September 30, 2017, three partners accounted for 88% of accounts receivable. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) For the three and nine months ended June 30, 2018 and 2017, 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 | 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. These ASUs are 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 modified retrospective method, with early adoption permitted as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within those annual periods. In April 2016, the FASB issued ASU 2016-10, “ Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing ” which further clarifies guidance related to identifying performance obligations and licensing implementation guidance contained in ASU 2014-09. In May 2016, the FASB issued ASU 2016-12, “ Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients ” which addresses narrow-scope improvements to the guidance on collectibility, noncash consideration, and completed contracts at transition and provides a practical expedient for contract modifications at transition and an accounting policy election related to the presentation of sales taxes and other similar taxes collected from customers. In December 2016, the FASB issued ASU No. 2016-20, “ Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers ,” which clarifies areas for correction or improvement in the Accounting Standards Codification. The Company will adopt the new revenue recognition standard effective October 1, 2018, utilizing the modified retrospective method. The Company is in the process of evaluating the impact the adoption of this standard will have on its financial statements and has performed an initial review of its major contracts with partners. Based on the initial reviews, the Company believes the adoption of the new standard will not have a significant quantitative impact on product revenues, as the timing of revenue recognition for product sales, profit sharing and royalties is not expected to significantly change. For the Company’s collaboration and partner arrangements, the consideration the Company is eligible to receive under these arrangements typically consists of nonrefundable upfront payments, reimbursement of research and development costs and milestone payments. The Company believes the adoption of the new standard will not have a significant quantitative impact on the revenue recognition of the reimbursement of research and development costs as the timing of the revenue recognition is not expected to significantly change. The Company continues to review the impact that this new standard will have on the timing of recognition for nonrefundable upfront payments and milestone payments as well as on its financial statement disclosures and has not made a determination on the impact to its financial statements. The Company is also evaluating changes to its accounting processes, internal controls and disclosures required to support the new standard. 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 separating leases into liability and asset components to be presented in the statement of financial position. Certain qualitative disclosures are also required to enable users of financial statements to understand the amount, timing, and uncertainty of cash flows arising from leases. The provisions of ASU 2016-02 are effective for annual 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. The Company is evaluating the effect that this ASU will have on the Company’s future financial position, results of operations or cash flows. In May 2017, the FASB issued ASU No. 2017-09, “ Compensation-Stock Compensation (Topic 718) – Scope of Modification Accounting (Topic 718) ”. This ASU clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification, and provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. An entity should account for the effects of a modification unless all three of the following conditions are met: (1) The fair value (or calculated value or intrinsic value, if such an alternative measurement method is used) of the modified award is the same as the fair value (or calculated value or intrinsic value, if such an alternative measurement is used) of the original award immediately before the original award is modified. If the modification does not affect any of the inputs to the valuation technique that the entity uses to value the award, the entity is not required to estimate the value immediately before and after the modification. (2) The vesting conditions of the modified award are the same as the vesting conditions of the original award immediately before the original award is modified. (3) The classification of the modified award as an equity instrument or a liability instrument is the same as the classification of the original award immediately before the original award is modified. This ASU is effective for annual periods beginning after December 15, 2017 and t he Company will adopt the standard effective October 1, 2018 . The adoption of this standard is not expected to have a material impact on the Company’s future financial position, results of operations or cash flows. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Jun. 30, 2018 | |
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 June 30, 2018 Level I Level II Level III Total Financial Assets: Money market funds $ 83,012 $ — $ — $ 83,012 As of September 30, 2017 Level I Level II Level III Total Financial Assets: Money market funds $ 57,928 $ — $ — $ 57,928 |
Schedule of differences between carrying values and estimated fair value of financial instruments | The following table lists both the carrying and fair values for such liabilities (in thousands): As of June 30, 2018 Carrying Fair Value Value Difference Long-term debt $ 386 $ 386 $ — As of September 30, 2017 Carrying Fair Value Value Difference Long-term debt $ 52,199 $ 55,888 $ 3,689 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Jun. 30, 2018 | |
Inventories | |
Schedule of Inventories | Inventories consist of the following (in thousands): As of June 30, As of September 30, 2018 2017 Raw materials $ 1,076 $ 1,683 Work in process 386 264 Finished goods 224 353 Total inventories $ 1,686 $ 2,300 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Jun. 30, 2018 | |
Schedule of the entity's outstanding debt | Long-Term Debt Outstanding long-term debt consists of the following (dollars in thousands): As of June 30, As of September 30, 2018 2017 Term loan agreement expiring June 30, 2019, less unamortized issuance costs of $697 and unamortized discount of $27 as of September 30, 2017. See terms of the agreement below. $ — $ 51,779 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 386 420 Total 386 52,199 Less current portion 49 13,172 Long-term portion $ 337 $ 39,027 |
Convertible Notes | |
Schedule of Convertible Notes | The table below summarizes the carrying value of the Convertible Notes as of June 30, 2018 (in thousands): Gross proceeds $ 120,000 Portion of proceeds allocated to equity component (additional paid-in capital) (48,671) Debt issuance costs (6,204) Portion of issuance costs allocated to equity component (additional paid-in capital) 2,517 Amortization of debt discount and debt issuance costs 2,379 Carrying value of Convertible Notes $ 70,021 |
Collaboration and Partner Arr24
Collaboration and Partner Arrangements (Tables) | 9 Months Ended |
Jun. 30, 2018 | |
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 June 30, Nine Months Ended June 30, 2018 2017 2018 2017 Mayne $ 1,572 $ 2,207 $ 6,261 $ 4,411 Par — — — 363 P&G 5,149 4,406 14,942 12,519 Agile 949 1,154 5,605 4,014 Other — 342 237 1,115 Total revenues $ 7,670 $ 8,109 $ 27,045 $ 22,422 |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Jun. 30, 2018 | |
Warrant | |
Warrants | |
Schedule of valuation assumptions for warrant | . The Company estimated the fair value of this warrant as of May 14, 2018 using the Black-Scholes option pricing model with the following key assumptions: Expected term (in years) Risk-free interest rate % Expected volatility % Expected dividend rate % |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Jun. 30, 2018 | |
Stock-Based Compensation | |
Summary of stock option activity | Weighted Weighted Stock Average Remaining Aggregate Options Exercise Contractual Intrinsic Value Outstanding Price Life (Years) (In thousands) Balance - September 30, 2017 3,787,222 $ 4.85 6.84 $ 23,819 Options granted 811,050 $ 11.59 Options exercised (108,705) $ 3.47 Options forfeited / cancelled (20,784) $ 7.48 Options expired (445) $ 2.22 Balance - June 30, 2018 4,468,338 $ 6.10 6.77 $ 11,990 Options exercisable - June 30, 2018 3,085,519 $ 5.01 5.92 $ 10,193 Options vested and expected to vest - June 30, 2018 4,328,101 $ 6.02 6.71 $ 11,835 |
Schedule of valuation assumptions used for stock options | Nine Months Ended June 30, 2018 Expected term (in years) - Risk-free interest rate % - % Expected volatility % - % Expected dividend rate % |
Schedule of restricted stock unit activity | Weighted Average Number of Grant Date Shares Fair Value Nonvested - September 30, 2017 144,375 $ 6.44 Granted 70,000 $ 11.59 Vested (27,502) $ 5.50 Forfeited — $ — Nonvested - June 30, 2018 186,873 $ 8.51 |
Schedule of valuation assumptions used for ESPP | As of June 30, 2018 Fair value of common stock $ – $ Grant price $ – $ Expected term (in years) – Expected volatility % – % Risk-free interest rate % – % Expected dividend rate % |
Schedule of employee stock-based compensation expense classified in the statements of operations and comprehensive loss | Employee stock-based compensation expense for the three and nine months ended June 30, 2018 and 2017 is classified in the condensed statements of operations and comprehensive loss as follows (in thousands): Three Months Ended June 30, Nine Months Ended June 30, 2018 2017 2018 2017 Cost of product revenues $ 127 $ 93 $ 348 $ 300 Cost of contract research and development revenues 96 61 266 169 Research and development 269 174 750 501 General and administrative 743 592 2,255 1,741 Total stock-based compensation $ 1,235 $ 920 $ 3,619 $ 2,711 |
Net Loss and Net Loss per Sha27
Net Loss and Net Loss per Share Attributable to Common Stockholders (Tables) | 9 Months Ended |
Jun. 30, 2018 | |
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 nine months ended June 30, 2018 and 2017 (in thousands, except share and per share data): Three Months Ended Nine Months Ended June 30, June 30, 2018 2017 2018 2017 Basic and diluted net loss per share Net loss attributable to common stockholders, basic and diluted $ (12,391) $ (13,384) $ (43,689) $ (34,850) Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 36,214,740 31,457,702 36,144,746 26,784,678 Net loss per share attributable to common stockholders, basic and diluted $ (0.34) $ (0.43) $ (1.21) $ (1.30) |
Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share attributable to common stockholders | Three Months Ended Nine Months Ended June 30, June 30, 2018 2017 2018 2017 Convertible notes 6,968,641 — 6,968,641 — Stock options to purchase common stock 4,468,338 4,058,134 4,468,338 4,058,134 Unvested restricted stock unit awards 186,873 102,500 186,873 102,500 Shares authorized under the 2014 ESPP 919,325 636,399 919,325 636,399 Common stock warrants 382,380 51,386 382,380 51,386 |
Organization, Description of 28
Organization, Description of Business and Summary of Significant Accounting Policies - Concentration of Credit Risk (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jun. 30, 2018USD ($)item | Jun. 30, 2017item | Jun. 30, 2018USD ($)item | Jun. 30, 2017item | Sep. 30, 2017USD ($)item | Mar. 31, 2018USD ($) | Dec. 04, 2014USD ($) | |
Liquidity | |||||||
Accumulated deficit | $ (258,970) | $ (258,970) | $ (215,281) | ||||
Net proceeds after issuance of convertible notes and payment of outstanding borrowings | $ 61,000 | ||||||
Term loan agreement expiring on June 30, 2019 | |||||||
Liquidity | |||||||
Face amount | $ 45,000 | ||||||
Revenues. | Customer concentration | Three partners | |||||||
Concentration of credit risk | |||||||
Number of partners | item | 3 | 3 | 3 | 3 | |||
Concentration risk percentage | 100.00% | 96.00% | 99.00% | 93.00% | |||
Accounts receivable | Credit concentration | Three partners | |||||||
Concentration of credit risk | |||||||
Number of partners | item | 3 | 3 | |||||
Concentration risk percentage | 99.00% | 88.00% | |||||
Convertible Notes | |||||||
Liquidity | |||||||
Face amount | $ 120,000 | $ 120,000 | $ 120,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring basis - Money market funds - USD ($) $ in Thousands | Jun. 30, 2018 | Sep. 30, 2017 |
Financial Assets | ||
Total financial assets | $ 83,012 | $ 57,928 |
Level I | ||
Financial Assets | ||
Total financial assets | $ 83,012 | $ 57,928 |
Fair Value Measurements (Level
Fair Value Measurements (Level III Valuation) (Details) - USD ($) $ in Thousands | 1 Months Ended | ||||
Mar. 31, 2018 | Jun. 30, 2018 | Mar. 05, 2018 | Sep. 30, 2017 | Dec. 04, 2014 | |
Term loan agreement expiring on June 30, 2019 | |||||
Fair value measurements | |||||
Principal amount | $ 45,000 | ||||
Principal amount outstanding | $ 51,800 | ||||
Convertible Notes | |||||
Fair value measurements | |||||
Principal amount | $ 120,000 | $ 120,000 | |||
Term of debt (in years) | 7 years | ||||
Portion of convertible notes proceeds allocated to debt | $ 71,300 | ||||
Portion of proceeds allocated to equity component (additional paid-in capital) | 48,671 | ||||
Carrying Value | |||||
Fair value measurements | |||||
Long-term debt | 386 | 52,199 | |||
Fair Value | |||||
Fair value measurements | |||||
Long-term debt | $ 386 | 55,888 | |||
Fair Value | Convertible Notes | |||||
Fair value measurements | |||||
Portion of convertible notes proceeds allocated to debt | $ 71,300 | ||||
Difference | |||||
Fair value measurements | |||||
Long-term debt | $ 3,689 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Sep. 30, 2017 |
Inventories | ||
Raw materials | $ 1,076 | $ 1,683 |
Work in process | 386 | 264 |
Finished goods | 224 | 353 |
Total inventories | $ 1,686 | $ 2,300 |
Debt (Details)
Debt (Details) $ in Thousands | Mar. 05, 2018USD ($) | Dec. 31, 2017installment | Jun. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($)installment | Dec. 31, 2018 | Dec. 04, 2014USD ($) |
Long-term Debt | |||||||
Carrying value of long-term debt | $ 386 | $ 52,199 | |||||
Less current portion | 49 | 13,172 | |||||
Long-term debt, net of current portion | 337 | 39,027 | |||||
Loss on extinguishment of long-term debt | (2,258) | ||||||
Term loan agreement expiring on June 30, 2019 | |||||||
Long-term Debt | |||||||
Carrying value of long-term debt | 51,779 | ||||||
Unamortized issuance costs | 697 | ||||||
Unamortized discount | 27 | ||||||
Interest rate (as a percent) | 15.00% | 15.00% | |||||
Face amount | $ 45,000 | ||||||
Maximum borrowing capacity | $ 45,000 | ||||||
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% | ||||||
Portion of interest due converted into additional notes | $ 7,500 | ||||||
Principal amount outstanding | 51,800 | ||||||
Percentage fee (as a percent) | 4.25% | 1.00% | 1.00% | ||||
Payment of debt, fees and other amounts due | $ 54,800 | ||||||
Term loan agreement expiring on June 30, 2019 | Forecast | |||||||
Long-term Debt | |||||||
Prepayment premium (as a percent) | 3.25% | ||||||
Notes payable due in November 2024 | |||||||
Long-term Debt | |||||||
Carrying value of long-term debt | 386 | 420 | |||||
Monthly payments of principal and interest | $ 6 | $ 6 | |||||
Interest rate (as a percent) | 7.00% | 7.00% |
Debt - Convertible Notes (Detai
Debt - Convertible Notes (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
Mar. 31, 2018USD ($)D$ / shares | Jun. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 05, 2018USD ($) | |
Convertible notes | ||||
Offering fees and expenses | $ 3,772,000 | |||
Initial portion of convertible notes proceeds allocated to equity component, net of issuance costs | 46,154,000 | |||
Gross proceeds | 120,000,000 | |||
Portion of issuance costs allocated to equity component (additional paid-in capital) | $ 2,500,000 | 2,500,000 | ||
Amortization of debt discount and debt issuance costs | 2,379,000 | |||
Carrying value Convertible Notes | 70,021,000 | 70,021,000 | ||
Convertible Notes | ||||
Convertible notes | ||||
Face amount | $ 120,000,000 | $ 120,000,000 | $ 120,000,000 | |
Interest rate (as a percent) | 5.00% | 5.00% | 5.00% | |
Optional amount of debt initial purchaser has option to purchase | $ 20,000,000 | |||
Net proceeds from debt offering | 116,200,000 | |||
Offering fees and expenses | $ 3,800,000 | |||
Conversion rate of common stock per $1 of principal amount | 0.0580552 | |||
Principal amount | $ 1,000 | |||
Conversion price (in dollars per share) | $ / shares | $ 17.22 | |||
Stock price trigger (as a percent) | 130.00% | |||
Number of trading days within 30 consecutive trading days | D | 20 | |||
Consecutive trading days, period | D | 30 | |||
Business days, period | 5 days | |||
Consecutive trading-day period | 5 days | |||
Maximum product of the closing sale price of shares of the Company's common stock and the applicable conversion rate for such trading day (as a percent) | 98.00% | |||
Portion of convertible notes proceeds allocated to debt | $ 71,300,000 | |||
Fair value of warrant | $ 2,400,000 | |||
Term of debt (in years) | 7 years | |||
Initial portion of convertible notes proceeds allocated to equity component, net of issuance costs | $ 46,200,000 | |||
Portion of convertible notes proceeds allocated to debt | 3,700,000 | |||
Debt discount and issuance costs subject to amortization | $ 52,400,000 | |||
Effective interest rate (as a percent) | 11.21% | 11.21% | ||
Interest expense | $ 3,400,000 | $ 4,300,000 | ||
Gross proceeds | 120,000,000 | |||
Portion of proceeds allocated to equity component (additional paid-in capital) | (48,671,000) | (48,671,000) | ||
Debt issuance costs | (6,204,000) | (6,204,000) | ||
Portion of issuance costs allocated to equity component (additional paid-in capital) | 2,517,000 | 2,517,000 | ||
Amortization of debt discount and debt issuance costs | 1,900,000 | 2,379,000 | ||
Carrying value Convertible Notes | $ 70,021,000 | $ 70,021,000 |
Collaboration and Partner Arr34
Collaboration and Partner Arrangements (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Collaboration and partner arrangements | ||||
Total revenues | $ 7,670 | $ 8,109 | $ 27,045 | $ 22,422 |
Mayne | ||||
Collaboration and partner arrangements | ||||
Total revenues | 1,572 | 2,207 | 6,261 | 4,411 |
Profit sharing | 200 | 100 | 600 | 700 |
Par | ||||
Collaboration and partner arrangements | ||||
Total revenues | 363 | |||
P&G | ||||
Collaboration and partner arrangements | ||||
Total revenues | 5,149 | 4,406 | 14,942 | 12,519 |
Agile | ||||
Collaboration and partner arrangements | ||||
Total revenues | $ 949 | 1,154 | 5,605 | 4,014 |
Other | ||||
Collaboration and partner arrangements | ||||
Total revenues | $ 342 | $ 237 | $ 1,115 |
Warrants (Details)
Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | May 14, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2017 |
Warrants | ||||
Amortization of debt discount and debt issuance costs | $ 2,379 | |||
Common stock warrants | ||||
Warrants | ||||
Warrants outstanding (in shares) | 382,380 | 51,386 | ||
Exercise price (in dollars per share) | $ 16.55 | $ 9.26 | ||
Warrant shares issued | 19,006 | |||
Stock exercised into shares of common stock using the net exercise provisions in the warrants (in shares) | 4,469 | |||
Common stock warrants | Minimum | ||||
Warrants | ||||
Warrant term | 7 years | |||
Common stock warrants | Maximum | ||||
Warrants | ||||
Warrant term | 10 years | |||
Common stock warrants | Cantor Fitzgerald | ||||
Warrants | ||||
Warrant term | 7 years | |||
Number of shares the warrant may be converted | 350,000 | |||
Fair value of warrant | $ 2,400 | |||
Debt issuance costs | $ 6,200 | |||
Exercise price (in dollars per share) | $ 17.22 | |||
Assumptions used in estimating weighted average fair value | ||||
Expected term (in years) | 7 years | |||
Risk-free interest rate (as a percent) | 2.96% | |||
Expected volatility (as a percent) | 70.00% | |||
Expected dividend rate (as a percent) | 0.00% | |||
Common stock warrants | Cantor Fitzgerald | Other Income | ||||
Warrants | ||||
Fair value of warrant | $ 1,800 |
Convertible Preferred Stock, 36
Convertible Preferred Stock, Common Stock and Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | ||
Dec. 31, 2015 | Jun. 30, 2018 | Sep. 30, 2017 | |
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 | 36,244,074 | 36,004,602 | |
Shares sold | 36,244,074 | 36,004,602 | |
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 - Stoc
Stock-Based Compensation - Stock Options (Details) $ / shares in Units, $ in Thousands | Jan. 16, 2018shares | Jan. 10, 2017shares | Mar. 19, 2014shares | Jun. 30, 2018USD ($)plan$ / sharesshares | Sep. 30, 2017USD ($)plan$ / sharesshares |
Stock-Based Compensation | |||||
Number of plans | plan | 3 | 3 | |||
Stock options | |||||
Assumptions used in estimating weighted average fair value | |||||
Risk-free interest rate, minimum | 2.08% | ||||
Risk-free interest rate, maximum | 2.72% | ||||
Expected volatility, minimum | 67.00% | ||||
Expected volatility, maximum | 73.00% | ||||
Expected dividend rate (as a percent) | 0.00% | ||||
Stock options | Minimum | |||||
Assumptions used in estimating weighted average fair value | |||||
Expected term (in years) | 5 years 3 months 7 days | ||||
Stock options | Maximum | |||||
Assumptions used in estimating weighted average fair value | |||||
Expected term (in years) | 6 years 6 months 26 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 | 1,444,716 | 902,298 | |||
Corium Plans | |||||
Stock-Based Compensation | |||||
Number of shares of common stock reserved under plan for issuance to employees | 6,396,840 | 5,060,829 | |||
Shares of common stock available for grant | 1,714,127 | 1,129,232 | |||
Corium Plans | Stock options | |||||
Stock-Based Compensation | |||||
Vesting period | 4 years | ||||
Stock Options Outstanding | |||||
Balance at the beginning of the period (in shares) | 3,787,222 | ||||
Granted (in shares) | 811,050 | ||||
Options exercised (in shares) | (108,705) | ||||
Options forfeited / cancelled (in shares) | (20,784) | ||||
Options expired | (445) | ||||
Balance at the end of the period (in shares) | 4,468,338 | 3,787,222 | |||
Options exercisable at the end of the period (in shares) | 3,085,519 | ||||
Options vested and expected to vest at the end of the period (in shares) | 4,328,101 | ||||
Weighted Average Exercise Price | |||||
Balance at the beginning of the period (in dollars per share) | $ / shares | $ 4.85 | ||||
Options granted (in dollars per share) | $ / shares | 11.59 | ||||
Options exercised (in dollars per share) | $ / shares | 3.47 | ||||
Options forfeited / cancelled (in dollars per share) | $ / shares | 7.48 | ||||
Options expired | $ / shares | 2.22 | ||||
Balance at the end of the period (in dollars per share) | $ / shares | 6.10 | $ 4.85 | |||
Options exercisable at the end of the period (in dollars per share) | $ / shares | 5.01 | ||||
Options vested and expected to vest at the end of the period (in dollars per share) | $ / shares | $ 6.02 | ||||
Weighted Average Remaining Contractual Life | |||||
Balance - Weighted Average Remaining Contractual Life | 6 years 9 months 7 days | 6 years 10 months 2 days | |||
Options exercisable at the end of the period | 5 years 11 months 1 day | ||||
Options vested and expected to vest at the end of the period | 6 years 8 months 16 days | ||||
Aggregate Intrinsic Value | |||||
Balance - Aggregate Intrinsic Value | $ | $ 11,990 | $ 23,819 | |||
Options exercisable at the end of the period | $ | 10,193 | ||||
Options vested and expected to vest at the end of the period | $ | $ 11,835 | ||||
Additional disclosures | |||||
Exercise price, minimum(in dollars per share) | $ / shares | $ 2.12 | ||||
Exercise price, maximum(in dollars per share) | $ / shares | $ 14.12 | ||||
Corium Plans | Stock options | Maximum | |||||
Stock-Based Compensation | |||||
Term of the plan | 10 years |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Unit Awards (Details) - Restricted stock unit awards - $ / shares | 9 Months Ended | |
Jun. 30, 2018 | Sep. 30, 2017 | |
Stock-Based Compensation | ||
Vesting period | 4 years | |
Maximum | ||
Stock-Based Compensation | ||
Term of the plan | 10 years | |
Corium Plans | ||
Number of Shares | ||
Balance at the beginning of the period (in shares) | 144,375 | |
Granted (in shares) | 70,000 | |
Vested (in shares) | (27,502) | |
Balance at the end of the period (in shares) | 186,873 | |
Outstanding awards | 214,375 | 144,375 |
Weighted Average Grant Date Fair Value | ||
Balance at the beginning of the period (in dollars per share) | $ 6.44 | |
Granted (in dollars per share) | 11.59 | |
Vested and released (in dollars per shares) | 5.50 | |
Balance at the end of the period (in dollars per share) | $ 8.51 |
Stock-Based Compensation - 2014
Stock-Based Compensation - 2014 Employee Stock Purchase Plan (Details) | Jan. 16, 2018shares | Jan. 10, 2017shares | Mar. 19, 2014shares | Jun. 30, 2018USD ($)$ / sharesshares | Jun. 30, 2017USD ($) | Jun. 30, 2018USD ($)$ / sharesshares | Jun. 30, 2017USD ($)shares | Nov. 20, 2017item | Sep. 30, 2017shares |
2014 Employee Stock Purchase Plan | |||||||||
Stock-based compensation | $ | $ 1,235,000 | $ 920,000 | $ 3,619,000 | $ 2,711,000 | |||||
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 | 310,000 | 919,325 | 919,325 | 636,399 | |||||
Stock-based compensation | $ | $ 73,000 | $ 60,000 | $ 146,000 | $ 224,000 | |||||
Additional shares authorized | shares | 409,224 | 267,565 | |||||||
Offering period | 2 years | ||||||||
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 | |||||||||
Expected volatility, minimum | 46.00% | ||||||||
Expected volatility, maximum | 84.00% | ||||||||
Risk-free interest rate, minimum | 1.08% | ||||||||
Risk-free interest rate, maximum | 2.58% | ||||||||
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 | ||||||||
Shares issued during the period | shares | 126,298 | 134,855 | |||||||
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 | $ / shares | $ 4.82 | $ 4.82 | |||||||
Grant Price | $ / shares | $ 4.10 | ||||||||
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 | $ / shares | $ 8.51 | $ 8.51 | |||||||
Grant Price | $ / shares | $ 7.23 | ||||||||
Expected term (in years) | 2 years |
Stock-Based Compensation - St40
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Employee stock-based compensation expense | ||||
Stock-based compensation | $ 1,235 | $ 920 | $ 3,619 | $ 2,711 |
Additional Disclosure | ||||
Unrecognized employee compensation cost, net of estimated forfeitures | 7,700 | $ 7,700 | ||
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 | 127 | 93 | $ 348 | 300 |
Cost of contract research and development revenues | ||||
Employee stock-based compensation expense | ||||
Stock-based compensation | 96 | 61 | 266 | 169 |
Research and development | ||||
Employee stock-based compensation expense | ||||
Stock-based compensation | 269 | 174 | 750 | 501 |
General and administrative | ||||
Employee stock-based compensation expense | ||||
Stock-based compensation | $ 743 | $ 592 | $ 2,255 | $ 1,741 |
Product Recall Liability (Detai
Product Recall Liability (Details) $ in Millions | 3 Months Ended | 9 Months Ended | 36 Months Ended | ||||
Jun. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Sep. 30, 2011item | Sep. 30, 2010item | Jun. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Oct. 31, 2012USD ($) | |
Product recall liability | |||||||
Recall liability | $ | $ 1.8 | $ 1.9 | $ 5 | ||||
Actavis | |||||||
Product recall liability | |||||||
Payment of settlement liability | $ | $ 0.1 | $ 0.3 | |||||
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 settlements | item | 2 |
Net Loss and Net Loss per Sha42
Net Loss and Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
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 | $ (12,391) | $ (13,384) | $ (43,689) | $ (34,850) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 36,214,740 | 31,457,702 | 36,144,746 | 26,784,678 |
Net loss per share attributable to common stockholders, basic and diluted (in dollars per share) | $ (0.34) | $ (0.43) | $ (1.21) | $ (1.30) |
Convertible Notes | ||||
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 | 6,968,641 | 6,968,641 | ||
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 | 4,468,338 | 4,058,134 | 4,468,338 | 4,058,134 |
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 | 186,873 | 102,500 | 186,873 | 102,500 |
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 | 919,325 | 636,399 | 919,325 | 636,399 |
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 | 382,380 | 51,386 | 382,380 | 51,386 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | Jan. 01, 2018 | Dec. 31, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Sep. 30, 2018 |
Income tax expense | $ 2 | $ 2 | |||
Statutory federal rate (as a percent) | 21.00% | 35.00% | |||
Forecast | |||||
Statutory federal rate (as a percent) | 24.53% |
Segment and Enterprise-Wide I44
Segment and Enterprise-Wide Information (Details) | 9 Months Ended |
Jun. 30, 2018item | |
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 |